Edexcel NVQ/competence-based qualifications€¦ · · 2018-04-20Edexcel NVQ/competence-based...

Specification

Level 3 NVQ Diploma in Laboratory Science (QCF)

First registration June 2011

Edexcel NVQ/competence-based qualifications

Edexcel, a Pearson company, is the UK’s largest awarding organisation offering vocational and academic qualifications and testing, to employers, training providers, colleges, schools, and other places of learning in the UK, and in over 85 countries worldwide.

Our specialist suite of qualifications include NVQs, Apprenticeships, WorkSkills, Functional Skills, Foundation Learning, as well as our exclusive range of BTECs, from entry level right through to Higher National Diplomas.

References to third party material made in this specification are made in good faith. Edexcel does not endorse, approve or accept responsibility for the content of materials, which may be subject to change, or any opinions expressed therein. (Material may include textbooks, journals, magazines and other publications and websites.)

Authorised by Martin Stretton Prepared by Sarah Bacon

Publications Code N027134

All the material in this publication is copyright © Pearson Education Limited 2011

Contents

Qualification title covered by this specification 1

Key features of the Level 3 Diploma in Laboratory Science (QCF) 2

What is the purpose of this qualification? 2

Who is this qualification for? 2

What are the potential job roles for those working towards this qualification? 2

What progression opportunities are available to learners who achieve this qualification? 3

What is the qualification structure for the Edexcel Level 3 Diploma in Laboratory Science (QCF)? 4

How is the qualification graded and assessed? 6

Assessment requirements/strategy 6

Types of evidence (to be read in conjunction with the assessment strategy in Annexe D) 7

Centre recognition and approval 8

Centre recognition 8

Approvals agreement 8

Quality assurance 8

What resources are required? 8

Unit format 9

Units 11

Unit 1: Maintaining health and safety in a laboratory environment 13

Unit 2: Maintaining effective and efficient working relationships in the laboratory 23

Unit 3: Providing leadership for a laboratory team 31

Unit 4: Encouraging problem solving and innovation in a laboratory team 39

Unit 5: Managing budgets for laboratory projects 47

Unit 6: Analysing laboratory samples using High Performance Liquid Chromatography (HPLC) 55

Unit 7: Analysing laboratory samples using Gas Chromatography (GC) 65

Unit 8: Analysing laboratory samples using Gas Chromatography-Mass Spectrometry (GCMS) 75

Unit 9: Analysing laboratory samples using Gas Chromatography-Thermal Conductivity (GCTC) 85

Unit 10: Analysing DNA/RNA samples using Polymerase Chain Reaction (PCR) and Quantitative PCR (QPCR) 95

Unit 11: Amplifying DNA samples using Polymerase Chain Reaction (PCR) 105

Unit 12: Maintaining cell lines for laboratory activities using cryogenic storage 115

Unit 13: Culturing/fermenting cells for laboratory activities using controlled fed batch or continuous culture fermentation 125

Unit 14: Maintaining cell lines for laboratory activities using sub-culture 135

Unit 15: Measuring, weighing and preparing compounds and solutions for laboratory use 143

Unit 16: Separating samples for laboratory activities using centrifugation 153

Unit 17: Analysing laboratory samples using light microscopy 163

Unit 18: Analysing laboratory samples using ultraviolet-visible spectrophotometer (UV-Vis) 173

Unit 19: Analysing laboratory samples using Circular Dichroism (CD) 183

Unit 20: Analysing laboratory samples using Fourier-transform infrared (FT-IR) spectroscopy 193

Unit 21: Analysing laboratory samples using Chromatography 203

Unit 22: Using and communicating laboratory information to authorised personnel 213

Unit 23: Analysing DNA using gel electrophoresis 221

Unit 24: Using statistical process control (SPC) for laboratory measurement processes 231

Further information 239

Useful publications 239

How to obtain National Occupational Standards 239

Professional development and training 240

Annexe A: Progression pathways 241

The Edexcel qualification framework for the Science sector 241

Annexe B: Quality assurance 243

Key principles of quality assurance 243

Quality assurance processes 243

Annexe C: Centre certification and registration 245

What are the access arrangements and special considerations for the qualifications in this specification? 245

Annexe D: Assessment requirements/strategy 247

Introduction 247

Assessor Requirements to Demonstrate Effective Assessment Practice 247

Assessor Technical Requirements 247

Verifier Requirements (internal and external) 248

Assessment Environment 250

Access to Assessment 251

Carrying Out Assessment 251

Minimum Performance Evidence Requirements 251

Assessing knowledge and understanding 252

Witness testimony 253

Quality Control of Assessment 253

Annexe E: Additional requirement for qualifications that use the term ‘NVQ’ in a QCF qualification title 255

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

1

Qual

ific

atio

n t

itle

cov

ered

by

this

spec

ific

atio

n

This

spec

ific

atio

n g

ives

you t

he

info

rmation y

ou n

eed t

o o

ffer

the

Edex

cel Le

vel 3 D

iplo

ma in L

abora

tory

Sci

ence

(Q

CF)

:

Qu

alifi

cati

on

tit

le

Qu

alifi

cati

on

N

um

ber

(QN

) R

eg

ula

tio

n

start

date

Edex

cel Le

vel 3 D

iplo

ma

in L

abora

tory

Sci

ence

(Q

CF)

600/1

732/6

08/0

4/1

1

This

qual

ific

atio

n h

as

bee

n a

ccre

dited

within

the

Qual

ific

ations

and C

redit F

ram

ework

(Q

CF)

and is

elig

ible

for

public

fundin

g a

s det

erm

ined

by

the

Dep

artm

ent

for

Educa

tion (

DfE

) under

Sec

tion 9

6 o

f th

e Le

arnin

g a

nd S

kills

Act

2000.

The

qual

ific

atio

n t

itle

s lis

ted a

bove

fea

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in t

he

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g lis

ts p

ublis

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annual

ly b

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regula

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Learn

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wher

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You s

hould

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the

QCF

Qualif

icat

ion A

ccre

ditat

ion N

um

ber

(Q

N),

when

you w

ish t

o s

eek

public

fundin

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your

learn

ers.

Each

unit w

ithin

a q

ualif

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ill a

lso h

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a u

niq

ue

QC

F re

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, w

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liste

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his

spec

ific

atio

n.

The

QCF

qual

ific

atio

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itle

and u

nit r

efer

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num

ber

s w

ill a

ppea

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s’ f

inal

cer

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tion d

ocu

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earn

ers

nee

d t

o

be

made

aw

are

of th

is w

hen

they

are

rec

ruited

by

the

centr

e an

d r

egis

tere

d w

ith E

dex

cel.

N027134 – Specification – Level 3 NVQ Diploma in Laboratory Science (QCF) – July 2011 © Pearson Education Limited 2011

2

Key features of the Level 3 Diploma in Laboratory Science (QCF)

This qualification:

is nationally recognised

is based on the Level 3 Laboratory Science National Occupational Standards (NOS). The NOS, assessment requirements/strategy and qualification structure(s) are owned by SEMTA.

The Edexcel Level 3 NVQ Diploma in Laboratory Science (QCF) have been approved as components for the Level 3 Laboratory Technicians Apprenticeship framework.

What is the purpose of this qualification?

The Edexcel Level 3 NVQ Diploma in Laboratory Science (QCF) provides recognition of the skills and knowledge of individuals who work in a laboratory. It covers health and safety; effective working relationships; dealing with laboratory specimens/samples and communicating information. It contains two Pathways: Clinical Analysis and Compound Analysis.

Who is this qualification for?

This qualification is for all learners aged 18 and above who are capable of reaching the required standards.

Edexcel’s policy is that the qualification should:

be free from any barriers that restrict access and progression

ensure equality of opportunity for all wishing to access the qualification(s).

What are the potential job roles for those working towards this qualification?

Analytical scientist

Biochemist

Biomedical scientist

Biologist

Biotechnologist

Clinical scientist

Microbiologist

Physicist

Research scientist

Education laboratory technician

Laboratory technician


3

Medical laboratory technician

Scientific laboratory technician

What progression opportunities are available to learners who achieve this qualification?

Progression from this qualification can be to other relevant level 2 and/or level 3 qualifications, for example:

Directly into employment

Edexcel Level 4 HNC in Applied Biology

Edexcel Level 4 HNC in Applied Chemistry

Further information is available in Annexe A.


4

What is the qualification structure for the Edexcel Level 3 Diploma in Laboratory Science (QCF)?

Individual units can be found in the Units section. The QCF level and credit value are given on the first page of each unit.

Learners must achieve a minimum of 71 credits by completing five common mandatory units and four optional units. One of these optional units must come from Group A and the other three optional units must come from Group B.

Unit Title Credit Level

Common Mandatory units

Unit 1: Maintaining health and safety in a laboratory environment

5 2

Unit 2: Maintaining effective and efficient working relationships in the laboratory

5 2

Unit 3: Providing leadership for a laboratory team 16 3

Unit 15: Measuring, weighing and preparing compounds and solutions for laboratory use

16 3

Unit 22: Using and communicating laboratory information to authorised personnel

6 3


Group A - Optional units

Unit 4: Encouraging problem solving and innovation in a laboratory team

16 3

Unit 5: Managing budgets for laboratory projects 8 3

Unit 24: Using statistical process control (SPC) for laboratory measurement processes

8 4

Group B - Optional units

Unit 6: Analysing laboratory samples using High Performance Liquid Chromatography (HPLC)

16 3

Unit 7: Analysing laboratory samples using Gas Chromatography (GC)

8 3

Unit 8: Analysing laboratory samples using Gas Chromatography-Mass Spectrometry (GCMS)

12 3

Unit 9: Analysing laboratory samples using Gas Chromatography-Thermal Conductivity (GCTC)

8 3


5


Unit 10: Analysing DNA/RNA samples using Polymerase Chain Reaction (PCR) and Quantitative PCR (QPCR)

8 3

Unit 11: Amplifying DNA samples using Polymerase Chain Reaction (PCR)

8 3

Unit 12: Maintaining cell lines for laboratory activities using cryogenic storage

6 3

Unit 13: Culturing/fermenting cells for laboratory activities using controlled fed batch or continuous culture fermentation

12 3

Unit 14: Maintaining cell lines for laboratory activities using sub-culture

8 3

Unit 16: Separating samples for laboratory activities using centrifugation

3 3

Unit 17: Analysing laboratory samples using light microscopy

6 3

Unit 18: Analysing laboratory samples using ultraviolet-visible spectrophotometer (UV-Vis)

8 3

Unit 19: Analysing laboratory samples using Circular Dichroism (CD)

16 3

Unit 20: Analysing laboratory samples using Fourier-transform infrared (FT-IR) spectroscopy

8 3

Unit 21: Analysing laboratory samples using Chromatography

9 3

Unit 23: Analysing DNA using gel electrophoresis 8 3


6

How is the qualification graded and assessed?

The overall grade for the qualification is a ‘pass’. The learner must achieve all the required units within the specified qualification structure.

To pass a unit the learner must:

� achieve all the specified learning outcomes

� satisfy all the assessment criteria by providing sufficient and valid evidence for each criterion

� show that the evidence is their own.

The qualifications are designed to be assessed:

� in the workplace or

� in conditions resembling the workplace, as specified in the assessment requirements/strategy for the sector, or

� as part of a training programme.

Assessment requirements/strategy

The assessment strategy for this qualification has been included in Annexe D. It has been developed by SEMTA in partnership with employers, training providers, awarding organisations and the regulatory authorities. The assessment strategy includes details on:

criteria for defining realistic working environments

roles and occupational competence of assessors, expert witnesses, internal verifiers and standards verifiers

quality control of assessment

evidence requirements.

Evidence of competence may come from:

current practice where evidence is generated from a current job role

a programme of development where evidence comes from assessment opportunities built into a learning/training programme whether at or away from the workplace

the Recognition of Prior Learning (RPL) where a learner can demonstrate that they can meet the assessment criteria within a unit through knowledge, understanding or skills they already possess without undertaking a course of learning. They must submit sufficient, reliable and valid evidence for internal and standards verification purposes. RPL is acceptable for accrediting a unit, several units or a whole qualification

a combination of these.


7

It is important that the evidence is:

Valid relevant to the standards for which competence is claimed

Authentic produced by the learner

Current sufficiently recent to create confidence that the same skill, understanding or knowledge persist at the time of the claim

Reliable indicates that the learner can consistently perform at this level

Sufficient fully meets the requirements of the standards.

Types of evidence (to be read in conjunction with the assessment strategy in Annexe D)

To successfully achieve a unit the learner must gather evidence which shows that they have met the required standard in the assessment criteria. Evidence can take a variety of different forms including the examples below. Centres should refer to the assessment strategy for information about which of the following are permissible.

direct observation of the learner’s performance by their assessor (O)

outcomes from oral or written questioning (Q&A)

products of the learner’s work (P)

personal statements and/or reflective accounts (RA)

outcomes from simulation, where permitted by the assessment strategy (S)

professional discussion (PD)

assignment, project/case studies (A)

authentic statements/witness testimony (WT)

expert witness testimony (EPW)

evidence of Recognition of Prior Learning (RPL).

The abbreviations may be used for cross-referencing purposes.

Learners can use one piece of evidence to prove their knowledge, skills and understanding across different assessment criteria and/or across different units. It is, therefore, not necessary for learners to have each assessment criterion assessed separately. Learners should be encouraged to reference the assessment criteria to which the evidence relates.

Evidence must be made available to the assessor, internal verifier and Edexcel standards verifier. A range of recording documents is available on the Edexcel website: www.edexcel.com. Alternatively, centres may develop their own.

http://www.edexcel.com/�


8

Centre recognition and approval

Centre recognition

Centres that have not previously offered Edexcel qualifications need to apply for and be granted centre recognition as part of the process for approval to offer individual qualifications. New centres must complete both a centre recognition approval application and a qualification approval application.

Existing centres will be given ‘automatic approval’ for a new qualification if they are already approved for a qualification that is being replaced by the new qualification and the conditions for automatic approval are met. Centres already holding Edexcel approval are able to gain qualification approval for a different level or different sector via Edexcel online.

Approvals agreement

All centres are required to enter into an approvals agreement which is a formal commitment by the head or principal of a centre to meet all the requirements of the specification and any linked codes or regulations. Edexcel will act to protect the integrity of the awarding of qualifications, if centres do not comply with the agreement. This could result in the suspension of certification or withdrawal of approval.

Quality assurance

Detailed information on Edexcel’s quality assurance processes is given in Annexe B.

What resources are required?

This qualification is designed to support learners working in the Laboratory Science sector. Physical resources need to support the delivery of the qualifications and the assessment of the learning outcomes and must be of industry standard. Centres must meet any specific resource requirements outlined in Annexe D: Assessment strategy. Staff assessing the learner must meet the requirements within the overarching assessment strategy for the sector.


9

Unit format

Each unit in this specification contains the following sections.

Unit title:

Unit code:

Unit reference number:

QCF level:

Credit value:

Guided learning hours:

Unit summary:

Assessment requirements/evidence requirements:

Assessment methodology:

Learning outcomes:

Assessment criteria:

Evidence type:

Portfolio reference:

Date:

The unit title is approved on the QCF and this form of words will appear on the learner’s Notification of Performance (NOP).

This is the unit owner’s reference number for the specified unit.

This code is a unique reference number for the unit.

All units and qualifications within the QCF have a level assigned to them, which represents the level of achievement. There are nine levels of achievement, from Entry level to level 8. The level of the unit has been informed by the QCF level descriptors and, where appropriate, the NOS and/or other sector/professional.

All units have a credit value. The minimum credit value is one, and credits can only be awarded in whole numbers. Learners will be awarded credits when they achieve the unit.

A notional measure of the substance of a qualification. It includes an estimate of the time that might be allocated to direct teaching or instruction, together with other structured learning time, such as directed assignments, assessments on the job or supported individual study and practice. It excludes learner-initiated private study.

This provides a summary of the purpose of the unit.

The assessment/evidence requirements are determined by the SSC. Learners must provide evidence for each of the requirements stated in this section.

Learning outcomes state exactly what a learner should know, understand or be able to do as a result of completing a unit.

The assessment criteria of a unit specify the standard a learner is expected to meet to demonstrate that a learning outcome, or a set of learning outcomes, has been achieved.

Learners must reference the type of evidence they have and where it is available for quality assurance purposes. The learner can enter the relevant key and a reference. Alternatively, the learner and/or centre can devise their own referencing system.

This provides a summary of the assessment methodology to be used for the unit.

The learner should use this box to indicate where the evidence can be obtained eg portfolio page number.

The learner should give the date when the evidence has been provided.


10


11

Units


12


13

Unit 1: Maintaining health and safety in a laboratory environment

Unit reference number: K/601/1703

QCF level: 2

Credit value: 5

Guided learning hours: 35

Unit summary

This unit covers the skills and knowledge needed to prove the competences required to maintain health and safety in the laboratory. The learner is required to observe all legal, statutory and organisational requirements, and the learner must be able to identify any potential hazards and risks to health and safety. The learner must also know what actions to take in case of an emergency and, as well as ensuring their own safety, they must show responsibility towards their colleagues and others. The learner will be required to work to the relevant standard operation procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP).

The learner’s responsibilities will require them to comply with health and safety requirements and organisational policy and procedures for the laboratory work that is undertaken. The learner must be able to recognise the limitations of their own competence with the laboratory work, and ask for appropriate help and advice in when it is needed. The learner will work under a high level of supervision, whilst taking responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will provide an understanding of their laboratory work, in order to apply safely the appropriate scientific principles and practices. The learner will be competent in the safe use of the materials, equipment, consumables and instruments used to perform the laboratory investigations, and with the procedures appropriate to their job. The learner’s depth of knowledge will be sufficient to provide a sound basis for safely carrying out the laboratory activities, to a level that will allow the department to meet any agreed targets.

The learner will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes. The learner will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace.

Assessment requirements

Assessment requirements are set down in Annexe D: Assessment strategy.


14

Assessment methodology

This unit is assessed in the workplace. Learners can enter the types of evidence they are presenting for assessment and the submission date against each assessment criterion. Alternatively, centre documentation should be used to record this information.

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

15

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Mai

nta

in h

ealth a

nd s

afet

y in

a lab

ora

tory

en

viro

nm

ent

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

Acc

ura

tely

ass

ess

hea

lth a

nd s

afet

y in

rel

atio

n t

o

thei

r w

ork

and t

he

labora

tory

1.3

Id

entify

hea

lth a

nd s

afet

y st

andar

d o

per

ating

pro

cedure

s fo

r al

l of th

e fo

llow

ing:

–

labora

tory

haz

ards

–

man

ual

han

dlin

g

–

unsa

fe p

ract

ices

–

VD

U &

RSI

polic

ies

–

spill

ages

–

oth

er (

ple

ase

spec

ify)

1.4

U

se t

he

appro

priat

e per

sonal pro

tect

ive

cloth

ing

and e

quip

men

t fo

r th

e w

ork

1.5

M

ake

safe

any

hea

lth a

nd s

afet

y haz

ard

s, a

nd

report

them

to t

he

appro

priat

e per

son a

s so

on a

s poss

ible

1.6

M

ainta

in t

he

secu

rity

of th

e la

bora

tory

, in

ac

cord

ance

with o

rgan

isat

ional

req

uir

emen

ts

1.7

Ensu

re t

hat

they

mai

nta

in t

hei

r w

ork

are

a t

o a

st

andar

d o

f hea

lth a

nd s

afe

ty w

hic

h is

consi

sten

t w

ith loca

l polic

ies

and leg

al r

equirem

ents

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

16

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.8

M

ainta

in a

nd u

se e

quip

men

t an

d m

ater

ials

in

acco

rdan

ce w

ith m

anufa

cture

rs’ in

stru

ctio

ns

and

loca

l sa

fety

reg

ula

tions

2

Mai

nta

in h

ealth a

nd s

afet

y in

a lab

ora

tory

en

viro

nm

ent

(continued

)

2.1

D

ispose

of

haz

ardous

mat

eria

ls,

was

te a

nd w

aste

co

nta

iner

s, s

afe

ly a

nd c

orr

ectly

2.2

D

ispose

of,

saf

ely,

sev

en o

f th

e fo

llow

ing,

in

acco

rdan

ce w

ith a

ppro

ved p

roce

dure

s:

–

shar

ps

–

bio

logic

al m

ater

ials

–

met

al

–

chem

ical

(so

lid a

nd liq

uid

)

–

pla

stic

s

–

gla

ss

–

clea

nin

g w

ipes

/tis

sues

–

aero

sol co

nta

iner

s

–

confiden

tial re

cord

s

–

dom

estic

was

te

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

17

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.3

D

ispose

of

was

te in t

hre

e th

e fo

llow

ing t

ypes

of

conta

iner

, in

acc

ord

ance

with a

ppro

ved p

ract

ices

:

–

shar

ps

conta

iner

s

–

colo

ur-

coded

pla

stic

bag

s

–

auto

clav

e bin

s

–

solv

ent

dru

ms

–

pro

priet

ary

conta

iner

s

2.4

Pre

pare

, use

and d

ispose

of dis

infe

ctan

ts,

safe

ly

and c

orr

ectly

2.5

Car

ry o

ut

dec

onta

min

atio

n o

f w

ork

surf

ace

s an

d

floors

eff

ective

ly

2.6

Tak

e th

e appro

priat

e pre

cautions

to p

rote

ct

them

selv

es a

nd o

ther

s during w

ork

ing

2.7

H

andle

saf

ely

thre

e of th

e fo

llow

ing h

azar

dous

subst

ance

s, in a

ccord

ance

with a

ppro

ved

pro

cedure

s:

–

flam

mab

les

–

corr

osi

ve c

hem

icals

–

toxi

c ch

emic

als

–

bio

logic

al m

ater

ials

2.8

Fo

llow

the

corr

ect

pro

cedure

, w

ithout

del

ay,

if

an

emer

gen

cy a

rise

s or

is s

usp

ecte

d

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

18

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.9

Fo

llow

est

ablis

hed

pro

cedure

s fo

r al

l of

the

follo

win

g e

mer

gen

cies

:

–

labora

tory

fire

–

spill

age

of

haz

ardous

subst

ance

s

–

gas

esc

apes

–

oth

er e

mer

gen

cies

(ple

ase

spec

ify)

3

Know

how

to m

ainta

in

hea

lth a

nd s

afe

ty in a

la

bora

tory

envi

ronm

ent

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

he

lear

ner

is

carr

ying o

ut

the

labora

tory

act

ivitie

s

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

stan

dar

d o

per

atin

g p

roce

dure

s, a

s se

t dow

n in loca

l la

bora

tory

oper

ating m

anuals

3.4

D

escr

ibe

the

import

ance

of

follo

win

g

man

ufa

cture

rs’ in

stru

ctio

ns

3.5

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.6

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

spec

imen

s/sa

mple

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

19

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.7

D

escr

ibe

the

spec

ific

safe

ty p

reca

utions

to b

e ta

ken

when

work

ing w

ith labora

tory

equip

men

t an

d

com

pute

r-bas

ed s

yste

ms

(to incl

ude

such

thin

gs

as

safe

ty g

uid

ance

rel

atin

g t

o t

he

use

of

visu

al dis

pla

y unit (

VD

U)

equip

men

t an

d w

ork

sta

tion

envi

ronm

ent

(such

as

lighting,

seat

ing,

posi

tionin

g

of eq

uip

men

t),

and r

epet

itiv

e st

rain

inju

ry (

RSI)

)

3.8

D

escr

ibe

the

iden

tity

of hea

lth a

nd s

afe

ty

repre

senta

tive

s (s

uch

as

the

Labora

tory

Safe

ty

Off

icer

, Sta

ff H

ealth &

Safe

ty R

epre

senta

tive

s an

d

Firs

t-Aid

ers)

3.9

D

escr

ibe

the

loca

tion a

nd c

orr

ect

use

of em

ergen

cy

equip

men

t (s

uch

as

fire

ext

inguis

her

s, incl

udin

g t

he

situ

atio

ns

in w

hic

h d

iffe

rent

types

of

fire

ex

tinguis

her

s ar

e use

d)

3.1

0

Des

crib

e th

e org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce

3.1

1

Des

crib

e th

e lin

es o

f co

mm

unic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

hei

r lin

ks

with t

he

rest

of

the

org

anis

ation

3.1

2

Des

crib

e th

e lim

its

of th

e le

arn

er’s

ow

n a

uth

ority

an

d t

o w

hom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

3

Exp

lain

why

risk

s in

the

labora

tory

should

be

asse

ssed

, an

d t

he

corr

ect

action t

o b

e ta

ken

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

20

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to m

ainta

in

hea

lth a

nd s

afe

ty in a

la

bora

tory

envi

ronm

ent

(continued

)

4.1

Exp

lain

how

to p

reve

nt

infe

ctio

n in lab

ora

tories

4.2

D

escr

ibe

loca

l pro

cedure

s fo

r es

cape

(incl

udin

g

esca

pe

route

s an

d a

ssem

bly

poin

ts)

4.3

D

escr

ibe

the

loca

tion o

f fire

ala

rms,

and h

ow

to

oper

ate

them

4.4

D

escr

ibe

the

loca

tion o

f sp

illage

kits

, an

d t

he

pro

cedure

s to

follo

w in t

he

even

t of sp

illag

es o

f ch

emic

als

and/o

r bio

logic

al fluid

s

4.5

D

escr

ibe

the

contr

ol of

subst

ance

s haz

ardous

to

hea

lth (

CO

SH

H)

regula

tions,

and t

hei

r ap

plic

atio

n in

the

labora

tory

4.6

D

escr

ibe

the

types

of haz

ard

s w

hic

h m

ay o

ccur

in

the

labora

tory

set

ting,

and h

ow

thes

e ca

n b

e m

inim

ised

4.7

D

escr

ibe

the

corr

ect

stora

ge

and d

isposa

l pro

cedure

s fo

r haza

rdous

mat

eria

ls (

incl

udin

g:

flam

mab

les,

corr

osi

ve,

har

mfu

l an

d t

oxi

c ch

emic

als)

4.8

D

escr

ibe

the

haz

ards

asso

ciat

ed w

ith d

isin

fect

ants

an

d o

ther

chem

ical

s (i

ncl

udin

g t

oxi

city

)

4.9

Exp

lain

the

mea

nin

g o

f th

e te

rms

‘dis

infe

ctio

n’ an

d

‘dec

onta

min

ation’, a

nd t

he

use

of dis

infe

ctants

4.1

0

Des

crib

e th

e re

aso

ns

for

dis

infe

ctin

g/d

econta

min

atin

g lab

ora

tory

surf

ace

s an

d e

quip

men

t

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

21

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

1

Exp

lain

why

it is

import

ant

to d

iffe

rentiat

e an

d

segre

gate

cat

egories

of w

ast

e (s

uch

as

usi

ng w

ast

e co

lour-

codin

g)

4.1

2

Des

crib

e th

e co

rrec

t pro

cedure

s fo

r th

e st

ora

ge,

tr

ansp

ort

and d

isposa

l of

wast

e

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


22


23

Unit 2: Maintaining effective and efficient working relationships in the laboratory

Unit reference number: M/601/1895

QCF level: 2

Credit value: 5


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to work effectively and efficiently in the laboratory, in accordance with approved procedures and practices. Prior to undertaking the laboratory activity, the learner will be required to carry out all the necessary preparations, within the scope of their responsibility. This may include preparing the work area and ensuring that it is in a safe condition for the intended activities, and ensuring that any materials, equipment and other resources required are available and are in a safe and usable condition. They will be required to work to the relevant standard operation procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP).

On completion of the laboratory activity, the learner will be required to return their immediate work area to an acceptable condition before undertaking further work requirements. This may involve placing completed work items in the correct location, returning and/or storing any materials and equipment in the correct condition/area, identifying any waste and arranging for its disposal, and reporting any defects or damage to the materials and equipment used.

The learner’s responsibilities will require them to comply with organisational policy and procedures for the laboratory investigations undertaken, and to report any problems with the activities, materials or equipment that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. The learner will work under a high level of supervision, whilst taking responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will provide a good understanding of their work, and will provide an informed approach to working efficiently and effectively in a laboratory environment. The learner will understand the need to work efficiently and effectively, and will know about the things that they need to consider when preparing and tidying up the work area. The learner will also need to know how to contribute to improvements, deal with problems, maintain effective working relationships, and how to agree and achieve their development objectives and targets, in adequate depth to provide a sound basis for carrying out the activities safely and correctly.


24

The learner will understand the safety precautions required when carrying out laboratory activities. The learner will be required to demonstrate safe working practices throughout, and will understand the responsibility they owe to themselves and others in the workplace.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

25

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Mai

nta

in e

ffec

tive

and

effici

ent

work

ing

rela

tionsh

ips

in t

he

labora

tory

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

Est

ablis

h a

nd m

ainta

in e

ffec

tive

work

ing

rela

tionsh

ips

1.4

Sust

ain p

osi

tive

work

ing r

elat

ionsh

ips

by

all of

the

follo

win

g:

–

work

ing in t

eam

s

–

support

ing o

ther

s

–

bei

ng c

ooper

ativ

e an

d fle

xible

–

pro

vidin

g c

lear

and a

ccura

te info

rmat

ion

1.5

M

ainta

in e

ffec

tive

work

ing r

elationsh

ips

with t

wo o

f th

e fo

llow

ing:

–

colle

agues

in t

hei

r ow

n w

ork

ing g

roup

–

super

viso

rs/m

anager

s

–

more

sen

ior

pro

fess

ional

s/sc

ientist

s

–

colle

agues

outs

ide

thei

r norm

al w

ork

ing g

roup

–

per

sons

exte

rnal

to t

hei

r org

anis

atio

n

1.6

M

eet

org

anis

atio

nal

sta

ndar

ds

for

appea

rance

and

beh

avio

ur

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

26

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Mai

nta

in e

ffec

tive

and

effici

ent

work

ing

rela

tionsh

ips

in t

he

labora

tory

(co

ntinued

)

2.1

D

eal w

ith d

isag

reem

ents

in a

n a

mic

able

and

const

ruct

ive

way

, so

that

good r

elat

ionsh

ips

are

mai

nta

ined

2.2

M

ainta

in c

om

munic

ation w

ith o

ther

s, t

o e

nsu

re t

hat

th

ey a

re k

ept

info

rmed

about

any

work

pla

ns

or

activi

ties

whic

h m

ay a

ffec

t th

em

2.3

Be

awar

e of th

e lim

its

of th

eir

skill

s, a

nd s

eek

assi

stan

ce f

rom

oth

ers

in a

polit

e an

d c

ourt

eous

way

without

causi

ng u

ndue

dis

ruption t

o n

orm

al

work

act

ivitie

s

2.4

Rev

iew

thei

r per

sonal

per

form

ance

and

dev

elopm

ent,

with t

he

appro

priat

e peo

ple

, at

re

gula

r in

terv

als

2.5

Rev

iew

per

sonal

dev

elopm

ent

obje

ctiv

es a

nd

targ

ets,

to incl

ude

one

of th

e fo

llow

ing:

–

dual

or

multi-

skill

ing

–

trai

nin

g o

n n

ew e

quip

men

t/te

chnolo

gy

–

under

stan

din

g o

f co

mpan

y w

ork

ing p

ract

ices

, pro

cedure

s, p

lans

and p

olic

ies

–

incr

ease

d r

esponsi

bili

ty

–

oth

er s

pec

ific

req

uirem

ents

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

27

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.6

Rec

ord

det

ails

of

work

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to m

ainta

in

effe

ctiv

e and e

ffic

ient

work

ing r

elat

ionsh

ips

in

the

labora

tory

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

stan

dar

d o

per

atin

g p

roce

dure

s, a

s se

t dow

n in loca

l la

bora

tory

oper

ating m

anuals

3.4

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.5

D

escr

ibe

the

purp

ose

of th

e sp

ecia

lity

of th

e dep

artm

ent

in w

hic

h t

hey

are

em

plo

yed,

and h

ow

it

fits

into

the

oth

er s

pec

ialit

ies

of th

e la

rger

org

anis

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

28

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

inte

ract

ions

whic

h t

ake

pla

ce b

etw

een

the

dep

artm

ent

and o

ther

spec

ialit

ies

in t

he

sam

e org

anis

atio

n

3.7

D

escr

ibe

the

inte

ract

ions

whic

h t

ake

pla

ce b

etw

een

the

spec

ialit

y in

whic

h t

hey

are

em

plo

yed a

nd

oth

ers

in t

he

sam

e sp

ecia

lity

else

wher

e

3.8

Exp

lain

how

thei

r w

ork

act

ivitie

s affec

t oth

ers

within

the

dep

artm

ent,

org

anis

ation a

nd t

he

com

munity

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

hei

r lin

ks

with t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

4

Know

how

to m

ainta

in

effe

ctiv

e and e

ffic

ient

work

ing r

elat

ionsh

ips

in

the

labora

tory

(co

ntinued

)

4.1

D

escr

ibe

the

lines

of

acco

unta

bili

ty w

ithin

the

dep

artm

ent

4.2

D

escr

ibe

the

gen

eral

funct

ion a

nd p

urp

ose

of al

l th

e re

leva

nt

labora

tories

4.3

D

escr

ibe

the

reaso

ns

why

good w

ork

ing

rela

tionsh

ips

are

im

port

ant

4.4

Exp

lain

how

to c

reate

and m

ainta

in g

ood w

ork

ing

rela

tionsh

ips

4.5

D

escr

ibe

the

met

hods

of w

ork

ing e

ffec

tive

ly w

ith

oth

ers

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

29

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.6

D

escr

ibe

the

pro

ble

ms

that

can a

ffec

t re

lationsh

ips

in t

he

work

pla

ce

4.7

D

escr

ibe

the

pro

cedure

s fo

r dea

ling w

ith

dis

agre

emen

ts w

ithin

the

work

pla

ce

4.8

D

escr

ibe

the

dep

art

men

tal per

form

ance

rev

iew

pro

cess

, and t

hei

r ro

le in t

his

pro

cess

4.9

D

escr

ibe

the

reaso

ns

why

effe

ctiv

e co

mm

unic

atio

n

is im

port

ant,

and t

he

met

hods

use

d f

or

com

munic

atin

g e

ffec

tive

ly

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


30


31

Unit 3: Providing leadership for a laboratory team

Unit reference number: J/601/8173

QCF level: 3

Credit value: 16


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to provide leadership to members of a laboratory team, in accordance with approved procedures. The learner is required to motivate and support them to achieve the objectives of the team and their personal work objectives. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their work to the appropriate people.

The learner will be required to plan the work of their team, and to set and agree individual objectives. They will help them solve technical problems, monitor their progress against the objectives they set, and provide feedback and guidance for improvements in their performance

The learner’s responsibilities will require them to comply with health and safety requirements, and organisational policy and procedures, for the laboratory work that is undertaken. They will be required to report any problems with the laboratory procedures that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to verbal/written instructions and standard operating procedures, with a minimum of supervision, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to team leading/building procedures. They will have an understanding of the necessary leadership skills, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace.


32





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

33

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Provi

de

leader

ship

for

a la

bora

tory

tea

m

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g lab

ora

tory

ite

ms

or

mat

eria

ls

1.3

U

se t

hre

e of th

e fo

llow

ing t

ypes

of pro

tect

ive

cloth

ing a

nd e

quip

men

t, a

s ap

pro

priat

e fo

r th

e sp

ecim

ens

bei

ng h

andle

d:

–

labora

tory

coat

–

face

mask

–

glo

ves

–

safe

ty g

lass

es

–

oth

er (

ple

ase

spec

ify)

1.4

Set

out

and p

osi

tive

ly c

om

munic

ate

the

purp

ose

an

d o

bje

ctiv

es o

f th

eir

labora

tory

tea

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

34

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g lea

der

ship

act

ivitie

s:

–

eval

uat

e th

e te

am

know

ledge

and s

kills

–

obta

in a

nd g

ive

info

rmat

ion t

o a

chie

ve t

eam

goal

s an

d o

bje

ctiv

es

–

pla

n t

ask

s an

d o

bje

ctiv

es for

the

team

to

acco

mplis

h s

et g

oals

–

repre

sent

the

team

at

mee

tings

and in

com

munic

atio

ns

with s

enio

r co

lleag

ues

and

cust

om

ers

–

impro

ve t

he

know

ledge,

ski

lls a

nd a

ttitude

of th

e te

am

1.6

In

volv

e te

am m

ember

s in

pla

nnin

g h

ow

thei

r la

bora

tory

tea

m w

ill a

chie

ve its

obje

ctiv

es

1.7

Ensu

re t

hat

each

mem

ber

of th

eir

labora

tory

tea

m

has

per

sonal

work

obje

ctiv

es a

nd u

nder

stands

how

ac

hie

ving t

hes

e w

ill c

ontr

ibute

to a

chie

vem

ent

of

the

team

’s o

bje

ctiv

es

2

Provi

de

leader

ship

for

a la

bora

tory

tea

m

(continued

)

2.1

Enco

ura

ge

and s

upport

thei

r la

bora

tory

tea

m

mem

ber

s to

ach

ieve

thei

r per

sonal

work

obje

ctiv

es

and t

hose

of th

e te

am

, an

d p

rovi

de

reco

gnitio

n

when

obje

ctiv

es h

ave

bee

n a

chie

ved

2.2

Ste

er t

hei

r la

bora

tory

tea

m s

ucc

essf

ully

thro

ugh

difficu

ltie

s an

d c

halle

nges

, in

cludin

g c

onflic

t w

ithin

th

e te

am

2.3

Enco

ura

ge

and r

ecognis

e cr

eativi

ty a

nd innova

tion

within

thei

r la

bora

tory

tea

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

35

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.4

G

ive

thei

r la

bora

tory

tea

m m

ember

s su

pport

and

advi

ce w

hen

nee

ded

2.5

M

onitor

act

ivitie

s an

d p

rogre

ss a

gai

nst

obje

ctiv

es

acro

ss t

hei

r la

bora

tory

tea

m,

and e

nco

ura

ge

resp

onsi

bili

ty in indiv

idual

s fo

r th

eir

ow

n a

ctio

ns

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

of th

eir

labora

tory

tea

m,

to a

uth

orise

d p

eople

, in

acc

ord

ance

with d

epar

tmen

tal an

d o

rgan

isat

ional

pro

cedure

s

2.7

Rec

ord

and c

om

munic

ate

to t

he

appro

priat

e peo

ple

, usi

ng a

ll of th

e fo

llow

ing:

–

verb

al re

port

–

writt

en o

r ty

ped

rep

ort

–

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

–

gra

phs/

char

ts

3

Know

how

to p

rovi

de

lead

ersh

ip f

or

a la

bora

tory

te

am

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

36

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.,

w

ork

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.5

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.6

D

escr

ibe

the

limits

of th

eir

ow

n a

uth

ority

and t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.7

D

escr

ibe

the

diffe

rent

way

s of

com

munic

ating

effe

ctiv

ely

with m

ember

s of a

team

3.8

Exp

lain

how

to s

et o

bje

ctiv

es w

hic

h a

re S

MART

(Spec

ific

, M

easu

rable

, Ach

ieva

ble

, Rea

listic

and

Tim

e-bound)

3.9

Exp

lain

how

to p

lan t

he

achie

vem

ent

of

team

obje

ctiv

es,

and t

he

import

ance

of in

volv

ing t

eam

m

ember

s in

this

pro

cess

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

37

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to p

rovi

de

lead

ersh

ip f

or

a la

bora

tory

te

am (

continued

)

4.1

D

escr

ibe

the

import

ance

of

show

ing t

eam

mem

ber

s how

thei

r per

sonal

work

obje

ctiv

es c

ontr

ibute

to

ach

ieve

men

t of

team

obje

ctiv

es

4.2

Exp

lain

how

to a

lloca

te w

ork

obje

ctiv

es a

nd

del

egate

res

ponsi

bili

ty t

o indiv

idual

s in

thei

r la

bora

tory

tea

m

4.3

Exp

lain

how

to s

elec

t an

d s

ucc

essf

ully

apply

a

limited

ran

ge

of m

ethods

for

motiva

ting,

support

ing

and e

nco

ura

gin

g t

eam

mem

ber

s an

d r

ecognis

ing

thei

r ac

hie

vem

ents

4.4

D

escr

ibe

the

types

of difficu

lty

and c

halle

nge

that

m

ay a

rise

(in

cludin

g c

onflic

t w

ithin

the

team

), a

nd

way

s of id

entify

ing a

nd o

verc

om

ing t

hem

4.5

D

escr

ibe

the

import

ance

of

enco

ura

gin

g o

ther

s to

ta

ke t

he

lead

, an

d w

ays

in w

hic

h t

his

can

be

achie

ved

4.6

D

escr

ibe

the

ben

efits

of,

and h

ow

to e

nco

ura

ge

and

reco

gnis

e, c

reat

ivity

and innova

tion w

ithin

a t

eam

4.7

D

escr

ibe

the

labora

tory

tea

m m

ember

s, t

hei

r purp

ose

, obje

ctiv

es a

nd p

lans

for

them

4.8

D

escr

ibe

the

types

of su

pport

and t

echnic

al a

dvi

ce

that

thei

r la

bora

tory

tea

m a

re lik

ely

to n

eed,

and

how

to r

espond t

o t

hes

e nee

ds

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

38

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


39

Unit 4: Encouraging problem solving and innovation in a laboratory team

Unit reference number: F/601/8172

QCF level: 3

Credit value: 16


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to encourage and support the identification and practical implementation of ideas from their laboratory team, in accordance with approved procedures. The learner is required to motivate and support them to achieve the objectives of the team and their personal work objectives. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to think creatively with their team, and to set and agree individual objectives. They will help them solve technical problems, monitor their progress the objectives they set, and provide feedback and guidance on their innovative ideas.

The learner’s responsibilities will require them to comply with health and safety requirements and organisational policy and procedures for the laboratory work that is undertaken. They will be required to report any problems with the laboratory procedures that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to verbal/written instructions and standard operating procedures, with a minimum of supervision, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to the introduction of new ideas. They will have an understanding of the required leadership skills, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to themselves and others in the workplace


40





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

41

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Enco

ura

ge

pro

ble

m

solv

ing a

nd innova

tion in

a la

bora

tory

tea

m

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s/sa

mple

s

1.3

U

se t

hre

e of th

e fo

llow

ing t

ypes

of pro

tect

ive

cloth

ing a

nd e

quip

men

t, a

s ap

pro

priat

e fo

r th

e sp

ecim

ens

bei

ng h

andle

d:

–

labora

tory

coat

–

face

mask

–

glo

ves

–

safe

ty g

lass

es

–

oth

er (

ple

ase

spec

ify)

1.4

M

otiva

te m

ember

s of th

eir

labora

tory

tea

m t

o

iden

tify

idea

s fo

r new

pro

duct

s/se

rvic

es a

nd

pro

cess

im

pro

vem

ents

1.5

Enco

ura

ge

idea

s fo

r al

l of

the

follo

win

g:

–

new

lab

ora

tory

pro

duct

s an

d/o

r se

rvic

es

–

impro

vem

ents

to e

xist

ing lab

ora

tory

pro

duct

s an

d/o

r se

rvic

es

–

impro

vem

ents

to e

xist

ing lab

ora

tory

pra

ctic

es,

pro

cedure

s, s

yste

ms

and w

ays

of w

ork

ing

1.6

Res

pond e

nth

usi

ast

ical

ly t

o idea

s id

entified

by

mem

ber

s of th

eir

labora

tory

tea

m,

and p

rovi

de

const

ruct

ive

feed

back

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

42

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.7

Enco

ura

ge

mem

ber

s of th

eir

labora

tory

tea

m t

o

shar

e, d

iscu

ss a

nd w

ork

toget

her

in d

evel

opin

g

initia

l id

eas

1.8

Enco

ura

ge

pro

ble

m s

olv

ing a

nd innova

tion,

usi

ng

thre

e of th

e fo

llow

ing:

–

forc

e-fiel

d a

nal

ysis

–

cause

-eff

ect

analy

sis

–

five

‘w

hys

’ an

alys

is

–

min

d-m

appin

g

–

focu

s gro

ups

–

bra

inst

orm

ing

–

flow

char

ting a

nal

ysis

–

fault-t

ree

anal

ysis

–

de

Bono’s

thin

king t

ools

–

oth

er (

ple

ase

spec

ify)

1.9

Id

entify

and p

urs

ue

opport

unitie

s to

work

with

oth

er lab

ora

tory

tea

ms

to g

ener

ate

and d

evel

op

idea

s

1.1

0

Dis

cuss

and a

gre

e w

ith m

ember

s of th

eir

labora

tory

te

am t

hose

idea

s w

hic

h s

hould

be

dev

eloped

fu

rther

, how

they

should

be

dev

eloped

and t

he

required

res

ourc

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

43

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Enco

ura

ge

pro

ble

m

solv

ing a

nd innova

tion in

a la

bora

tory

tea

m

(continued

)

2.1

Pr

ovi

de

ongoin

g s

upport

, en

coura

gem

ent

and

reso

urc

es t

o m

ember

s of th

eir

labora

tory

tea

m w

ho

are

dev

elopin

g a

nd t

esting idea

s, a

nd h

elp t

o

rem

ove

any

obst

acl

es

2.2

Agre

e th

e pra

ctic

al im

ple

men

tation o

f id

eas,

base

d

on t

he

iden

tified

ben

efits,

ris

ks a

nd r

equired

re

sourc

es,

when

they

hav

e th

e au

thority

to d

o s

o

2.3

Support

mem

ber

s of

thei

r la

bora

tory

tea

m in

subm

itting form

al p

roposa

ls a

nd p

lans

for

the

pra

ctic

al im

ple

men

tation o

f id

eas

to o

ther

peo

ple

fo

r ap

pro

val

2.4

O

vers

ee t

he

pra

ctic

al im

ple

men

tation o

f id

eas

by

thei

r la

bora

tory

tea

m,

and m

onitor

and r

eport

on

pro

gre

ss

2.5

Enco

ura

ge

and d

evel

op t

he

crea

tivi

ty o

f m

ember

s of th

eir

labora

tory

tea

m

2.6

Enco

ura

ge

mem

ber

s of th

eir

labora

tory

tea

m t

o

take

acc

epta

ble

ris

ks in p

urs

uin

g innova

tion

2.7

Ensu

re t

hat

the

origin

ators

and d

evel

oper

s of an

y id

eas

whic

h a

re s

ucc

essf

ully

im

ple

men

ted r

ecei

ve

reco

gnitio

n for

thei

r ach

ieve

men

t

2.8

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

of th

eir

labora

tory

tea

m t

o a

uth

orise

d p

eople

, in

acc

ord

ance

with d

epar

tmen

tal an

d o

rgan

isat

ional

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

44

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.9

Rec

ord

and c

om

munic

ate

det

ails

of w

ork

done,

to

the

appro

priate

peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to e

nco

ura

ge

pro

ble

m s

olv

ing a

nd

innova

tion in a

lab

ora

tory

te

am

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.,

w

ork

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.5

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

45

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

limits

of th

eir

ow

n a

uth

ority

and t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.7

D

escr

ibe

the

org

anis

atio

nal

polic

y an

d s

trat

egy

for

innova

tion

3.8

D

escr

ibe

the

org

anis

atio

nal

guid

elin

es a

nd

pro

cedure

s fo

r dev

elopin

g a

nd im

ple

men

ting n

ew

idea

s

3.9

D

escr

ibe

the

ben

efits

of

innova

tion t

o t

hei

r te

am

, th

e ove

rall

org

anis

atio

n a

nd its

cust

om

ers

3.1

0

Exp

lain

how

to m

ake

tim

e ava

ilable

for

iden

tify

ing

and d

evel

opin

g idea

s

3.1

1

Exp

lain

how

to m

otiva

te p

eople

to g

ener

ate

and

dev

elop idea

s

4

Know

how

to e

nco

ura

ge

pro

ble

m s

olv

ing a

nd

innova

tion in a

lab

ora

tory

te

am (

continued

)

4.1

Exp

lain

how

to p

rovi

de

const

ruct

ive

feed

bac

k on

idea

s to

indiv

idual

s

4.2

D

escr

ibe

the

import

ance

of

good c

om

munic

atio

n t

o

innova

tion,

and h

ow

to e

nco

ura

ge

it a

cross

thei

r te

am

4.3

D

escr

ibe

the

pote

ntial

obst

acl

es t

o c

reat

ivity,

and

how

they

can

be

min

imis

ed

4.4

D

escr

ibe

the

import

ance

of

giv

ing fee

dback

on

initia

l id

eas

4.5

Exp

lain

how

initia

l id

eas

mig

ht

be

furt

her

dev

eloped

an

d t

este

d

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

46

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.6

Exp

lain

how

to r

ecognis

e an

d m

anag

e risk

in

innova

tion

4.7

Exp

lain

how

to d

evel

op form

al pro

posa

ls a

nd p

lans

for

the

pra

ctic

al im

ple

men

tation o

f an

idea

, an

d

how

to s

upport

oth

ers

in d

oin

g t

his

4.8

Exp

lain

how

to d

evel

op c

reat

ivity

in t

hem

selv

es a

nd

oth

ers

4.9

D

escr

ibe

the

reso

urc

es r

equir

ed for

crea

tivi

ty a

nd

innova

tion,

par

ticu

larly

tim

e

4.1

0

Exp

lain

how

to e

nco

ura

ge

thei

r la

bora

tory

tea

m t

o

lear

n f

rom

mis

take

s as

soci

ate

d w

ith n

ew idea

s

4.1

1

Exp

lain

how

to r

ecognis

e th

e ac

hie

vem

ents

of th

e origin

ato

rs/d

evel

oper

s of id

eas

whic

h h

ave

bee

n

succ

essf

ully

im

ple

men

ted

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


47

Unit 5: Managing budgets for laboratory projects

Unit reference number: L/601/8174

QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to manage project budgets in the laboratory, in accordance with approved procedures and practices. Prior to undertaking the laboratory activity, the learner will be required to carry out all the necessary preparations, within the scope of their responsibility. This may include preparing the work area and ensuring that it is in a safe condition for the intended activities, and ensuring that any materials, equipment and other resources required are available and are in a safe and usable condition. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner’s responsibilities will include ownership of, and responsibility for a budget for a laboratory team and activity. It will involve preparing, submitting and agreeing a budget for a set operating period. It also involves monitoring actual performance against the agreed budget, and taking necessary action in response to identified variances and any unforeseen developments.

The learner’s responsibilities will require them to comply with organisational policy and procedures for the laboratory projects undertaken, and to report any problems with the activities, materials or equipment that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will work with minimal supervision, whilst taking responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to budgeting procedures. They will have an understanding of the budgeting process and its application, and will know about the process used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out laboratory activities. They will be required to demonstrate safe working practices throughout, and will understand the responsibility they owe to themselves and others in the workplace.


48





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

49

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Man

age

budget

s fo

r la

bora

tory

pro

ject

s 1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

Eva

luat

e ava

ilable

info

rmat

ion a

nd c

onsu

lt w

ith

oth

ers

to p

repar

e a

real

istic

budget

for

the

resp

ective

are

a or

act

ivity

of w

ork

.

1.4

M

anag

e budget

s fo

r all

of th

e fo

llow

ing:

–

accr

ued

v a

ctual

pro

ject

exp

enditure

–

pro

ject

cas

hflow

–

pro

ject

tea

m c

ost

s

–

pro

ject

equip

men

t co

sts

–

pro

ject

res

ourc

e co

sts

–

oth

er (

ple

ase

spec

ify)

1.5

Subm

it t

he

pro

pose

d b

udget

to t

he

rele

vant

peo

ple

in

the

org

anis

atio

n,

for

appro

val and t

o a

ssis

t th

e ove

rall

finan

cial

pla

nnin

g p

roce

ss

1.6

D

iscu

ss a

nd,

if a

ppro

priat

e, n

egotiat

e th

e pro

pose

d

budget

with t

he

rele

vant

peo

ple

in t

he

org

anis

atio

n,

and a

gre

e th

e final

budget

1.7

U

se t

he

agre

ed b

udget

to a

ctiv

ely

monitor

and

contr

ol per

form

ance

for

the

resp

ective

are

a o

r ac

tivi

ty o

f w

ork

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

50

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.8

Agre

e budget

s w

ith t

wo o

f th

e fo

llow

ing:

–

colle

agues

in t

hei

r ow

n w

ork

ing g

roup

–

super

viso

rs/m

anager

s

–

more

sen

ior

pro

fess

ional

s/sc

ientist

s

–

colle

agues

outs

ide

thei

r norm

al w

ork

ing g

roup

–

per

sons

exte

rnal

to t

hei

r org

anis

atio

n

2

Man

age

budget

s fo

r la

bora

tory

pro

ject

s (c

ontinued

)

2.1

Id

entify

the

cause

s of an

y si

gnific

ant

variance

s bet

wee

n w

hat

was

budget

ed a

nd w

hat

act

ual

ly

hap

pen

ed,

and t

ake

pro

mpt

corr

ective

act

ion,

obta

inin

g a

gre

emen

t fr

om

the

rele

vant

peo

ple

if

required

2.2

Pr

opose

rev

isio

ns

to t

he

budget

, if n

eces

sary

, in

re

sponse

to v

arian

ces

and/o

r si

gnific

ant

or

unfo

rese

en d

evel

opm

ents

, an

d d

iscu

ss a

nd a

gre

e th

e re

visi

ons

with t

he

rele

vant

peo

ple

in t

he

org

anis

atio

n

2.3

Pr

ovi

de

ongoin

g info

rmat

ion o

n p

erfo

rman

ce

agai

nst

the

budget

to r

elev

ant

peo

ple

in t

hei

r org

anis

atio

n

2.4

Advi

se t

he

rele

vant

peo

ple

as

soon a

s poss

ible

if

they

hav

e id

entified

evi

den

ce o

f pote

ntially

fr

audule

nt

activi

ties

2.5

G

ather

info

rmat

ion f

rom

im

ple

men

tation o

f th

e budget

to a

ssis

t in

the

pre

par

atio

n o

f fu

ture

budget

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

51

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

2.7

Rec

ord

and c

om

munic

ate

det

ails

of w

ork

done,

to

the

appro

priate

peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to m

anag

e budget

s fo

r la

bora

tory

pro

ject

s

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

stan

dar

d o

per

atin

g p

roce

dure

s, a

s se

t dow

n in loca

l la

bora

tory

oper

ating m

anuals

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

fact

ors

, pro

cess

es a

nd t

rends

likel

y to

af

fect

the

sett

ing o

f budget

s in

thei

r in

dust

ry/s

ecto

r

3.5

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

hei

r lin

ks

with t

he

rest

of

the

org

anis

ation

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

52

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

limits

of th

eir

ow

n a

uth

ority

and t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.7

D

escr

ibe

the

purp

ose

s of

budget

ary

syst

ems

3.8

Exp

lain

wher

e to

get

, an

d h

ow

to e

valu

ate,

the

avai

lable

info

rmation in o

rder

to b

e ab

le t

o p

repar

e a

real

istic

budget

3.9

D

escr

ibe

the

import

ance

of

spen

din

g t

ime

and

consu

ltin

g w

ith o

ther

s in

pre

par

ing a

budget

4

Know

how

to m

anag

e budget

s fo

r la

bora

tory

pro

ject

s (c

ontinued

)

4.1

Exp

lain

how

to d

iscu

ss,

neg

otiate

and c

onfirm

a

budget

with p

eople

who c

ontr

ol th

e finan

ces,

and

the

key

fact

ors

that

should

be

cove

red

4.2

Exp

lain

how

to u

se a

budget

to a

ctiv

ely

monitor

and c

ontr

ol per

form

ance

for

a def

ined

are

a or

activi

ty o

f w

ork

4.3

D

escr

ibe

the

mai

n c

ause

s of

varian

ces,

and h

ow

to

iden

tify

them

4.4

Exp

lain

what

diffe

rent

types

of

corr

ective

act

ion

could

be

take

n t

o a

ddre

ss iden

tified

var

iance

s

4.5

Exp

lain

how

unfo

rese

en d

evel

opm

ents

can

aff

ect

a budget

, an

d h

ow

to d

eal w

ith t

hem

4.6

D

escr

ibe

the

import

ance

of agre

eing r

evis

ions

to

the

budget

and o

f co

mm

unic

atin

g t

he

changes

4.7

D

escr

ibe

the

import

ance

of

pro

vidin

g r

egula

r in

form

atio

n o

n p

erfo

rman

ce a

gai

nst

the

budget

to

oth

er p

eople

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

53

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.8

D

escr

ibe

the

types

of fr

audule

nt

activi

ties

, an

d h

ow

to

iden

tify

them

4.9

D

escr

ibe

the

import

ance

of usi

ng t

he

imple

men

tation o

f th

e budget

to iden

tify

in

form

atio

n a

nd les

sons

for

the

pre

para

tion o

f fu

ture

budget

s

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


54


55

Unit 6: Analysing laboratory samples using High Performance Liquid Chromatography (HPLC)

Unit reference number: R/601/8175

QCF level: 3

Credit value: 16


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using high performance liquid chromatography (HPLC) analysers, in accordance with approved procedures. The learner is required to confirm that the HPLC analyser is ready for the analysis to be performed and that the required reagents are available. In operating the analyser, they will be expected to follow the correct procedures for calling the analyser-operating program, entering operating parameters for analysis, dealing with error messages and executing the program activities safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the HPLC analyser in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, make the required adjustments, in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the HPLC work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions, with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying HPLC analyser procedures. They will have an understanding of the HPLC analysis process and its application, and will know about the analyser, samples and reagents used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.


56






N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

57

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng H

igh

Perf

orm

ance

Liq

uid

Chro

mat

ogra

phy

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

equip

men

t is

cal

ibra

ted,

safe

and

read

y fo

r oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

58

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g H

igh P

ress

ure

Liq

uid

Chro

mat

ogra

phy

(HPL

C)

oper

atio

ns:

–

confirm

that

the

mach

ine

is r

eady

for

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts,

mobile

phase

and m

achin

e oper

atin

g p

rogra

m s

equen

ces

–

inst

all th

e co

lum

n a

nd p

rim

e th

e sy

stem

–

ensu

re t

hat

spec

imen

s ar

e in

suitab

le

conta

iner

s/vi

als

(e.g

. not

ove

rfill

ed,

poorly

crim

ped

or

wro

ng s

epta

)

–

ensu

re t

hat

mach

ine

sett

ings

are

adju

sted

as

and w

hen

req

uired

for

the

anal

ysis

–

allo

w f

or

suitab

le s

yste

m e

quili

bra

tion b

y ru

nnin

g m

ethod c

onditio

ns

and m

onitoring t

he

bas

elin

e

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

seq

uen

ce r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m s

equen

ce is

at

the

corr

ect

start

poin

t, a

nd t

hat

all th

e data

han

dlin

g is

read

y fo

r dat

a acq

uis

itio

n

–

oper

ate

the

anal

yser

, fo

llow

ing t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

59

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

1.7

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

1.8

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2

Anal

yse

labora

tory

sa

mple

s usi

ng H

igh

Perf

orm

ance

Liq

uid

Chro

mat

ogra

phy

(continued

)

2.1

Lo

ad s

pec

imen

s fo

r anal

ysis

and r

un p

rogra

m

sequen

ces

corr

ectly

2.2

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

2.3

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

60

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.4

Conduct

four

of th

e fo

llow

ing a

nal

yses

:

–

single

pea

k ass

ay

–

multi-

pea

k det

erm

ination

–

sam

ple

agre

emen

t ca

lcula

tions

(pre

cise

re

plic

atio

n)

–

syst

em s

uitab

ility

pea

k asy

mm

etry

pla

te c

ount

reso

lution b

y EP

and U

SP c

alcu

lations

–

glo

bal

res

ponse

fact

or

–

stan

dar

d a

gre

emen

t ca

lcula

tion

–

bra

cket

res

ponse

fac

tor

–

linea

r ra

nge

stan

dar

ds

2.5

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

2.6

Rec

ord

det

ails

of th

e an

alys

is w

ork

, an

d

com

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

61

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Hig

h P

erfo

rman

ce L

iquid

Chro

mat

ogra

phy

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

62

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

Hig

h P

ress

ure

Liq

uid

Chro

mat

ogra

phy

(HPLC

) in

vest

igat

ions

conduct

ed

by

the

labora

tory

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

conta

iner

s use

d f

or

HPL

C a

naly

sis

in t

he

labora

tory

, an

d o

ther

es

sential

res

ourc

es n

eeded

for

each

inve

stig

atio

n

3.1

3

Des

crib

e th

e im

port

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy

3.1

4

Des

crib

e th

e m

ain fea

ture

s of th

e H

PLC

anal

yser

, an

d t

he

acce

ssories

that

can

be

use

d

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Hig

h P

erfo

rman

ce L

iquid

Chro

mat

ogra

phy

(continued

)

4.1

D

escr

ibe

the

various

HPL

C a

naly

ser

oper

ations

that

ca

n b

e per

form

ed,

and t

he

met

hods

and e

quip

men

t use

d

4.2

Exp

lain

how

to r

ecord

and p

repar

e st

andard

sa

mple

s, r

eagen

ts a

nd m

obile

phas

es

4.3

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g c

onsu

mab

les

and m

ainte

nan

ce ite

ms

in

the

HPL

C a

nal

yser

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

63

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.4

Exp

lain

how

to inte

rpre

t th

e an

aly

ser

visu

al dis

pla

y an

d u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.5

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.6

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m,

if t

he

HPL

C h

as b

een s

topped

bef

ore

co

mple

tion o

f th

e pro

gra

m

4.7

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

analy

sis

to b

e co

nduct

ed

4.8

Exp

lain

how

to m

easu

re t

he

effici

ency

of a c

olu

mn

4.9

Exp

lain

how

to d

eter

min

e th

e sy

mm

etry

of a

pea

k (e

.g.

taili

ng)

4.1

0

Exp

lain

how

to d

eter

min

e th

e se

par

atio

n a

nd

reso

lution o

f th

e co

lum

n

4.1

1

Exp

lain

how

to a

pply

sta

ndar

d a

gre

emen

t, r

esponse

fa

ctor,

sam

ple

pre

cisi

on,

stan

dar

d lin

eari

ty

calc

ula

tions

4.1

2

Des

crib

e th

e ty

pic

al H

PLC a

nd c

olu

mn fau

lts,

and

the

act

ions

to b

e ta

ken if th

ey o

ccur

4.1

3

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

64

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


65

Unit 7: Analysing laboratory samples using Gas Chromatography (GC)

Unit reference number: Y/601/8176

QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using gas chromatography (GC) analysers, in accordance with approved procedures. The learner is required to confirm that the GC analyser is ready for the analysis to be performed, and that the required reagents and standards are available. In operating the analyser, they will be expected to following the correct procedures for calling the analyser operating program, entering operating parameters for analysis, dealing with error messages and executing the program safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the GC analyser in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, to make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the GC work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions, with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying GC analyser procedures. They will have an understanding of the GC analysis process and its application, and will know about the analyser, the use of appropriate standards, samples and reagents, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.


66






N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

67

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng G

as

Chro

mat

ogra

phy

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

equip

men

t is

cal

ibra

ted,

safe

and

read

y fo

r oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

68

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g o

per

atio

ns:

–

confirm

that

the

mach

ine

is r

eady

for

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts,

mobile

phase

and m

achin

e oper

atin

g p

rogra

m s

equen

ces

–

inst

all th

e co

lum

n a

nd p

rim

e th

e sy

stem

–

ensu

re t

hat

spec

imen

s ar

e in

suitab

le

conta

iner

s/vi

als

(e.g

. not

ove

rfill

ed,

poorly

crim

ped

or

wro

ng s

epta

)

–

ensu

re t

hat

mach

ine

sett

ings

are

adju

sted

as

and w

hen

req

uired

for

the

anal

ysis

–

allo

w f

or

suitab

le s

yste

m e

quili

bra

tion b

y ru

nnin

g m

ethod c

onditio

ns

and m

onitoring t

he

bas

elin

e and s

tandar

d p

eak

hei

ght

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

seq

uen

ce r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m s

equen

ce is

at

the

corr

ect

start

poin

t, a

nd t

hat

all th

e data

han

dlin

g is

read

y fo

r dat

a acq

uis

itio

n

–

oper

ate

the

anal

yser

, fo

llow

ing t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

69

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

1.7

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

2

Anal

yse

labora

tory

sa

mple

s usi

ng G

as

Chro

mat

ogra

phy

(continued

)

2.1

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2.2

Lo

ad s

tandar

ds

and s

pec

imen

s fo

r an

alys

is a

nd r

un

pro

gra

m s

equen

ces

corr

ectly

2.3

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

2.4

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

70

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.5

Car

ry o

ut

anal

yser

mai

nte

nan

ce invo

lvin

g e

ight

of

the

follo

win

g:

–

chan

gin

g lin

ers

–

chan

gin

g inje

ctor

septa

–

chan

gin

g w

aste

arm

sep

ta

–

chan

gin

g r

inse

res

ervo

ir f

luid

–

venting t

he

pum

p

–

chan

gin

g p

um

p o

il

–

chan

gin

g s

yrin

ges

–

chan

gin

g f

erru

les

–

chan

gin

g c

apill

ary

colu

mns

–

pre

par

ing a

nd c

onditio

nin

g c

olu

mns

–

pac

king c

olu

mns

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

71

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of th

e pre

par

ation w

ork

and

com

munic

ate

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Gas

Chro

mat

ogra

phy

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

72

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

gas

chro

mat

ogra

phy

(GC)

inve

stig

ations

conduct

ed b

y th

e la

bora

tory

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

conta

iner

s use

d f

or

GC a

nal

ysis

in t

he

labora

tory

and o

ther

es

sential

res

ourc

es n

eeded

for

each

inve

stig

atio

n

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Gas

Chro

mat

ogra

phy

(continued

)

4.1

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy

4.2

D

escr

ibe

the

mai

n fea

ture

s of th

e G

C a

naly

ser,

and

the

acc

esso

ries

that

can b

e use

d

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

73

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.3

D

escr

ibe

the

various

GC a

naly

ser

oper

atio

ns

that

can b

e per

form

ed,

and t

he

met

hods

and e

quip

men

t use

d

4.4

D

escr

ibe

the

various

sourc

es o

f co

mbust

ion a

nd

carr

ier

gas

es,

and t

he

import

ance

of

ensu

ring

consi

sten

cy o

f su

pply

and f

low

rat

e an

d c

hec

king

for

leaks

2,1

7

Exp

lain

how

to r

ecord

and p

repar

e st

andard

sa

mple

s, r

eagen

ts a

nd m

obile

phas

es

4.5

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g c

onsu

mab

les

and m

ainte

nan

ce ite

ms

in

the

GC

anal

yser

4.6

Exp

lain

how

to inte

rpre

t th

e an

aly

ser

visu

al dis

pla

y an

d u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.7

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.8

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m if th

e G

C h

as

bee

n s

topped

bef

ore

co

mple

tion o

f th

e pro

gra

m

4.9

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

analy

sis

to b

e co

nduct

ed

4.1

0

Des

crib

e th

e ty

pic

al G

C f

aults,

and t

he

actions

to b

e ta

ken if th

ey o

ccur

4.1

1

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

74

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


75

Unit 8: Analysing laboratory samples using Gas Chromatography-Mass Spectrometry (GCMS)

Unit reference number: D/601/8177

QCF level: 3

Credit value: 12


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using gas chromatography-mass spectrometry (GCMS) analysers, in accordance with approved procedures. The learner is required to confirm that the GCMS analyser is ready for the analysis to be performed, and that the required reagents and standards are available. In operating the analyser, they will be expected to follow the correct procedures for calling the analyser operating program, entering operating parameters for analysis, dealing with error messages and executing the program safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the GCMS analyser in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the GCMS activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions, with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying GCMS analyser procedures. They will have an understanding of the GCMS analysis process and its application, and will know about the analyser, the use of appropriate standards, samples and reagents, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.


76






N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

77

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng G

as

Chro

mat

ogra

phy-

Mas

s Spec

trom

etry

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

equip

men

t is

cal

ibra

ted,

safe

and

read

y fo

r oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

78

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g o

per

atio

ns:

–

confirm

that

the

mach

ine

is r

eady

for

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts,

mobile

phase

and m

achin

e oper

atin

g p

rogra

m s

equen

ces

–

inst

all th

e co

lum

n a

nd p

rim

e th

e sy

stem

–

ensu

re t

hat

spec

imen

s ar

e in

suitab

le

conta

iner

s/vi

als

(e.g

. not

ove

rfill

ed,

poorly

crim

ped

or

wro

ng s

epta

)

–

ensu

re t

hat

mach

ine

sett

ings

are

adju

sted

as

and w

hen

req

uired

for

the

anal

ysis

–

allo

w f

or

suitab

le s

yste

m e

quili

bra

tion b

y ru

nnin

g m

ethod c

onditio

ns

and m

onitoring t

he

bas

elin

e and s

tandar

d p

eak

hei

ght

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

seq

uen

ce r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m s

equen

ce is

at

the

corr

ect

start

poin

t, a

nd t

hat

all th

e data

han

dlin

g is

read

y fo

r dat

a acq

uis

itio

n

–

oper

ate

the

anal

yser

, fo

llow

ing t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

79

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

1.7

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

2

Anal

yse

labora

tory

sa

mple

s usi

ng G

as

Chro

mat

ogra

phy-

Mas

s Spec

trom

etry

(co

ntinued

)

2.1

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2.2

Lo

ad s

tandar

ds

and s

pec

imen

s fo

r an

alys

is a

nd r

un

pro

gra

m s

equen

ces

corr

ectly

2.3

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

2.4

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

80

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.5

Car

ry o

ut

anal

yser

mai

nte

nan

ce invo

lvin

g t

en o

f th

e fo

llow

ing:

–

chan

gin

g lin

ers

–

chan

gin

g inje

ctor

septa

–

chan

gin

g w

aste

arm

sep

ta

–

chan

gin

g r

inse

res

ervo

ir f

luid

–

venting t

he

pum

p

–

chan

gin

g p

um

p o

il

–

chan

gin

g s

yrin

ges

–

chan

gin

g f

erru

les

–

chan

gin

g c

apill

ary

colu

mns

–

pre

par

ing a

nd c

onditio

nin

g c

olu

mns

–

pac

king c

olu

mns

–

chan

gin

g e

lect

ron m

ultip

lier

and r

epla

cem

ent

horn

s

–

chan

gin

g fila

men

ts

–

chan

gin

g ion s

ourc

e

–

chan

gin

g M

S c

hem

ical

s

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

81

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of th

e pre

par

ation w

ork

and

com

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Gas

Chro

mat

ogra

phy-

Mas

s Spec

trom

etry

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

82

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

Gas

Chro

mat

ogra

phy-

Mas

s Spec

trom

etry

(G

CM

S)

inve

stig

ations

conduct

ed b

y th

e la

bora

tory

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

conta

iner

s use

d f

or

GCM

S a

naly

sis

in t

he

labora

tory

, an

d o

ther

es

sential

res

ourc

es n

eeded

for

each

inve

stig

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

83

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Gas

Chro

mat

ogra

phy-

Mas

s Spec

trom

etry

(c

ontinued

)

4.1

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy

4.2

D

escr

ibe

the

mai

n fea

ture

s of th

e G

CM

S a

nal

yser

, an

d t

he

acce

ssories

that

can

be

use

d

4.3

D

escr

ibe

the

various

GCM

S a

naly

ser

oper

atio

ns

that

ca

n b

e per

form

ed,

and t

he

met

hods

and e

quip

men

t use

d

4.4

D

escr

ibe

the

various

sourc

es o

f co

mbust

ion a

nd

carr

ier

gas

es,

and t

he

import

ance

of

ensu

ring

consi

sten

cy o

f su

pply

and f

low

rat

e an

d c

hec

king

for

leaks

4.5

Exp

lain

how

to r

ecord

and p

repar

e st

andard

sa

mple

s, r

eagen

ts a

nd m

obile

phas

es

4.6

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g c

onsu

mab

les

and m

ainte

nan

ce ite

ms

in

the

GC

MS a

nal

yser

4.7

Exp

lain

how

to inte

rpre

t th

e an

aly

ser

visu

al dis

pla

y an

d u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.8

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.9

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m if th

e G

CM

S h

as b

een s

topped

bef

ore

co

mple

tion o

f th

e pro

gra

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

84

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

0

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

analy

sis

to b

e co

nduct

ed

4.1

1

Des

crib

e th

e ty

pic

al G

CM

S f

aults,

and t

he

actions

to

be

take

n if th

ey o

ccur

4.1

2

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


85

Unit 9: Analysing laboratory samples using Gas Chromatography-Thermal Conductivity (GCTC)

Unit reference number: H/601/8178

QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using gas chromatography-thermal conductivity (GCTC) analysers, in accordance with approved procedures. The learner is required to confirm that the GCTC analyser is ready for the analysis to be performed, and that the required reagents and standards are available. In operating the analyser, they will be expected to follow the correct procedures for calling the analyser operating program, entering operating parameters for analysis, dealing with error messages and executing the program safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

They will be required to set up and operate the GCTC analyser in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

Their responsibilities will require them to comply with standard operating procedures for the GCTC activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions, with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

Their underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying GCTC analyser procedures. They will have an understanding of the GCTC analysis process and its application, and will know about the analyser, the use of appropriate standards, samples and reagents, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.


86

They will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect yourself and others in the workplace.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

87

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng G

as

Chro

mat

ogra

phy-

Ther

mal

Conduct

ivity

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

equip

men

t is

cal

ibra

ted,

safe

and

read

y fo

r oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

88

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g o

per

atio

ns:

–

confirm

that

the

mach

ine

is r

eady

for

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts,

mobile

phase

and m

achin

e oper

atin

g p

rogra

m s

equen

ces

–

chec

k re

fere

nce

gas

flo

w f

or

ther

mal

co

nduct

ivity

anal

ysis

–

chec

k th

erm

al c

onduct

ivity

refe

rence

supply

cy

linder

lev

els

–

inst

all th

e co

lum

n a

nd p

rim

e th

e sy

stem

–

ensu

re t

hat

spec

imen

s ar

e in

suitab

le

conta

iner

s/vi

als

(e.g

. not

ove

rfill

ed,

poorly

crim

ped

or

wro

ng s

epta

)

–

confirm

the

mach

ine

sett

ings

are

adju

sted

as

and w

hen

req

uired

for

the

anal

ysis

–

allo

w f

or

suitab

le s

yste

m e

quili

bra

tion b

y ru

nnin

g m

ethod c

onditio

ns

and m

onitoring t

he

bas

elin

e and s

tandar

d p

eak

hei

ght

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

seq

uen

ce r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m m

ethod a

nd

sequen

ce is

at t

he

corr

ect

star

t poin

t, a

nd t

hat

al

l th

e data

han

dlin

g is

read

y fo

r data

acq

uis

itio

n

–

oper

ate

the

anal

yser

, fo

llow

ing t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

89

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

1.7

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

1.8

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2

Anal

yse

labora

tory

sa

mple

s usi

ng G

as

Chro

mat

ogra

phy-

Ther

mal

Conduct

ivity

(continued

)

2.1

Lo

ad s

tandar

ds

and s

pec

imen

s fo

r an

alys

is a

nd r

un

pro

gra

m s

equen

ces

corr

ectly

2.2

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

2.3

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

90

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.4

Car

ry o

ut

anal

yser

mai

nte

nan

ce invo

lvin

g e

ight

of

the

follo

win

g:

–

chan

gin

g lin

ers

–

chan

gin

g inje

ctor

septa

–

chan

gin

g w

aste

arm

sep

ta

–

chan

gin

g r

inse

res

ervo

ir f

luid

–

venting t

he

pum

p

–

chan

gin

g p

um

p o

il

–

chan

gin

g s

yrin

ges

–

chan

gin

g f

erru

les

–

chan

gin

g c

apill

ary

colu

mns

–

pre

par

ing a

nd c

onditio

nin

g c

olu

mns

–

pac

king c

olu

mns

2.5

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

91

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.6

Rec

ord

det

ails

of pre

par

atio

n w

ork

, an

d

com

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Gas

Chro

mat

ogra

phy-

Ther

mal

Conduct

ivity

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

92

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

Gas

Chro

mat

ogra

phy-

Ther

mal

Conduct

ivity

(GCTC)

inve

stig

atio

ns

conduct

ed b

y th

e la

bora

tory

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

conta

iner

s use

d f

or

GCTC a

nal

ysis

in t

he

labora

tory

, an

d o

ther

es

sential

res

ourc

es n

eeded

for

each

inve

stig

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

93

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Gas

Chro

mat

ogra

phy-

Ther

mal

Conduct

ivity

(continued

)

4.1

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy

4.2

D

escr

ibe

the

mai

n fea

ture

s of th

e G

CTC a

nal

yser

, an

d t

he

acce

ssories

that

can

be

use

d

4.3

D

escr

ibe

the

various

GCTC a

naly

ser

oper

atio

ns

that

ca

n b

e per

form

ed,

and t

he

met

hods

and e

quip

men

t use

d

4.4

D

escr

ibe

the

various

sourc

es o

f co

mbust

ion a

nd

carr

ier

gas

es,

and t

he

import

ance

of

ensu

ring

consi

sten

cy o

f su

pply

and f

low

rat

e an

d c

hec

king

for

leaks

4.5

Exp

lain

how

to r

ecord

and p

repar

e st

andard

sa

mple

s, r

eagen

ts a

nd m

obile

phas

es

4.6

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g c

onsu

mab

les

and m

ainte

nan

ce ite

ms

in

the

GCTC a

nal

yser

4.7

Exp

lain

how

to inte

rpre

t th

e an

aly

ser

visu

al dis

pla

y an

d u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.8

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.9

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m if th

e G

CTC h

as b

een s

topped

bef

ore

co

mple

tion o

f th

e pro

gra

m.

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

94

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

0

Iden

tify

wher

e to

obta

in t

he

standar

d o

per

atin

g

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

analy

sis

to b

e co

nduct

ed

4.1

1

Des

crib

e th

e ty

pic

al G

CTC fau

lts,

and t

he

actions

to

be

take

n if th

ey o

ccur

4.1

2

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


95

Unit 10: Analysing DNA/RNA samples using Polymerase Chain Reaction (PCR) and Quantitative PCR (QPCR)


QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using Polymerase Chain Reaction and Quantitative PCR, in accordance with approved procedures. The learner is required to confirm that the required reagents are available and have been stored in the way indicated by the supplier. Before carrying out the analysis, they will be expected to follow the correct procedures for ensuring that a high standard of cleanliness is maintained with due regard for the risk of cross contamination of samples. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous chemicals in such a way that they are contained within designated areas whilst in use, and are disposed of in the correct way. They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the PCR thermal/light cycler, choosing the required program, in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, to make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the PCR activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions, with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying PCR, thermal/light cycler procedures. They will have an understanding of the PCR reaction and the reagents used, the use of fluorescent dyes in visualizing DNA and RNA, and in QPCR, and the interpretation of amplified DNA, in adequate depth to provide a sound


96

background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out the preparation and disposal of hazardous chemicals, and will understand the nature of the risks involved with these chemicals. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect yourself and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

97

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

DN

A/R

NA s

am

ple

s usi

ng P

oly

mer

ase

Chai

n

Rea

ctio

n a

nd Q

uan

tita

tive

PC

R

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

anal

yser

and a

ssoci

ated

eq

uip

men

t ar

e re

ady

for

oper

ation

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

98

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g:

–

confirm

that

the

mach

ine

is r

eady

for

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts a

nd r

eact

ion m

ixtu

res

to t

he

des

ired

lev

el o

f acc

ura

cy

–

load

the

ther

mal

/lig

ht

cycl

er,

and s

elec

t th

e co

rrec

t oper

atin

g p

rogra

m

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

seq

uen

ce r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m m

ethod a

nd

sequen

ce is

at t

he

corr

ect

star

t poin

t, a

nd t

hat

al

l th

e data

han

dlin

g is

read

y fo

r data

acq

uis

itio

n

–

oper

ate

the

anal

yser

, fo

llow

ing t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

1.6

Ensu

re t

hat

reag

ents

are

sto

red c

orr

ectly

and a

re

mai

nta

ined

at

the

corr

ect

tem

per

ature

during u

se

1.7

Sta

rt a

nd r

un t

he

oper

atin

g s

yste

m,

and s

elec

t th

e ap

pro

priat

e pro

gra

m f

or

the

analy

sis

to b

e done

1.8

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

and r

eport

those

that

cannot

be

reso

lved

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

99

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Anal

yse

DN

A/R

NA s

am

ple

s usi

ng P

oly

mer

ase

Chai

n

Rea

ctio

n a

nd Q

uan

tita

tive

PC

R (

continued

)

2.1

Lo

ad s

pec

imen

s fo

r anal

ysis

and r

un p

rogra

m

sequen

ces

corr

ectly

2.2

Ensu

re t

hat

corr

ect

posi

tive

and n

egat

ive

contr

ols

ar

e in

cluded

for

each

run o

f th

e th

erm

al/l

ight

cycl

er

2.3

Rec

ord

and e

valu

ate

dat

a in a

ccord

ance

with

stan

dar

d o

per

atin

g p

roce

dure

s and t

he

LIM

S

2.4

Sto

re r

eact

ion m

ixtu

res

at

the

corr

ect

tem

per

ature

, an

d d

ispose

of sp

ent

mat

eria

ls in a

ccord

ance

with

dep

artm

enta

l hea

lth a

nd s

afe

ty p

roce

dure

s

2.5

Conduct

all

the

follo

win

g:

–

calib

ration o

f m

icro

pip

ette

s

–

stora

ge

of

reag

ents

–

stora

ge

of

sam

ple

s

–

han

dlin

g a

nd d

isposa

l of dan

ger

ous

chem

ical

s

–

sele

ctin

g a

nd r

unnin

g t

he

pro

gra

m

–

reco

rdin

g d

ata

in t

he

LIM

S

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

100

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of th

e an

alys

is w

ork

, an

d

com

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

DN

A/R

NA s

ample

s usi

ng

Poly

mer

ase

Chai

n

Rea

ctio

n a

nd Q

uan

tita

tive

PC

R

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

anal

ytic

al

activi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

101

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.,

w

ork

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

PCR inve

stig

atio

ns

conduct

ed b

y th

e la

bora

tory

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

conta

iner

s use

d f

or

sam

ple

sto

rage

and P

CR a

nal

ysis

in t

he

labora

tory

, an

d o

ther

ess

ential

res

ourc

es n

eeded

fo

r ea

ch inve

stig

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

102

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to a

nal

yse

DN

A/R

NA s

ample

s usi

ng

Poly

mer

ase

Chai

n

Rea

ctio

n a

nd Q

uan

tita

tive

PC

R (

continued

)

4.1

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

4.2

D

escr

ibe

the

mai

n fea

ture

s of th

e PC

R a

nal

yser

, an

d t

he

under

lyin

g a

ctio

n o

f th

e re

agen

ts invo

lved

in

the

react

ion m

ixtu

re

4.3

D

escr

ibe

the

various

PCR t

her

mal

cyc

ler

oper

atio

ns

that

can

be

per

form

ed,

and t

he

met

hods

and

react

ion m

ixtu

res

use

d

4.4

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g p

rogra

ms

and m

ainte

nan

ce ite

ms

in t

he

ther

mal

cyc

ler

4.5

Exp

lain

how

to inte

rpre

t th

e cy

cler

vis

ual

dis

pla

y an

d u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.6

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.7

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m if th

e cy

cler

has

bee

n s

topped

bef

ore

co

mple

tion o

f th

e pro

gra

m

4.8

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

pro

cedure

to b

e co

nduct

ed

4.9

D

escr

ibe

the

typic

al t

her

mal

cyc

ler

faults,

and t

he

actions

to b

e ta

ken if th

ey o

ccur

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

103

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f harm

ful ch

emic

als

and c

onta

min

ated

eq

uip

men

t

4.1

1

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


104


105

Unit 11: Amplifying DNA samples using Polymerase Chain Reaction (PCR)


QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample amplification using Polymerase Chain Reaction (PCR), in accordance with approved procedures. The learner is required to confirm that the necessary reagents are available and have been stored in the way indicated by the supplier. They will be expected to follow the correct procedures, whilst ensuring that a high standard of cleanliness is maintained with due regard for the risk of cross contamination of samples. The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous chemicals, ensuring that they are contained within designated areas whilst in use and are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the PCR thermal cycler, choosing the required program, in line with safe working practices and approved procedures and, where necessary, to make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the PCR work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying PCR and thermocycler procedures. They will have an understanding of the PCR reaction and the reagents used, in sufficient detail to provide a sound background for carrying out the laboratory activities to the required specification.


106

The learner will understand the safety precautions required when carrying out the preparation and disposal of dangerous chemicals, and they will be aware of the risks involved with these chemicals. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

107

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

DN

A s

ample

s usi

ng P

oly

mer

ase

Chai

n

Rea

ctio

n

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

or

hav

e th

e ap

pro

priat

e sa

fety

co

ntr

ols

in p

lace

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

equip

men

t is

cle

an,

safe

and

read

y fo

r oper

atio

n a

nd t

hat

any

anci

llary

eq

uip

men

t is

calib

rate

d

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

108

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g a

mplif

icat

ion

oper

atio

ns:

–

use

corr

ectly

store

d r

eagen

ts,

and t

haw

on ice

–

set

up r

eact

ions,

and m

ainta

in o

n ice

prior

to

tran

sfer

to t

he

ther

mocy

cler

–

confirm

that

the

ther

mocy

cler

is

read

y fo

r th

e am

plif

icat

ion p

roce

ss

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts a

nd r

eact

ion m

ixtu

res,

acc

ord

ing t

o t

he

scale

req

uired

–

add s

pec

imen

s to

the

react

ion m

ixtu

re,

load

the

ther

mocy

cler

and s

elec

t th

e co

rrec

t oper

ating

pro

gra

m

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

seq

uen

ce a

nd r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m s

equen

ce is

at

the

corr

ect

start

poin

t an

d t

hat

all

the

data

han

dlin

g is

read

y fo

r dat

a acq

uis

itio

n

–

oper

ate

the

PCR e

quip

men

t, f

ollo

win

g t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing p

ract

ices

and p

roce

dure

s at

all tim

es

–

rem

ove

the

amplif

ied D

NA a

nd s

tore

corr

ectly

for

the

nex

t oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

109

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Ensu

re t

hat

reag

ents

are

sto

red,

thaw

ed a

nd

tran

sfer

red t

o t

he

ther

mocy

cler

corr

ectly

1.7

Corr

ectly

quan

tify

the

DN

A c

once

ntr

atio

n o

f ea

ch

sam

ple

, by

spec

trosc

opic

tec

hniq

ues

(O

D260nm

)

2

Anal

yse

DN

A s

ample

s usi

ng P

oly

mer

ase

Chai

n

Rea

ctio

n (

continued

)

2.1

Sta

rt a

nd r

un t

he

ther

mocy

cler

, an

d iden

tify

the

appro

priat

e PC

R a

mplif

icat

ion p

rogra

m

2.2

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol an

d

report

those

that

can

not

be

reso

lved

2.3

Lo

ad t

he

PCR t

her

mal

cyc

ler

with r

eact

ions

conta

inin

g t

he

DN

A,

and r

un t

he

amplif

icat

ion

pro

gra

m c

orr

ectly

2.4

Tra

nsf

er t

he

amplif

ied D

NA t

o t

he

corr

ect

loca

tion

for

furt

her

pro

cess

ing

2.5

Com

ple

te a

ll of

the

follo

win

g a

ctiv

itie

s:

–

calib

rating o

f m

icro

pip

ette

s

–

stora

ge

of

reag

ents

–

stora

ge

of

sam

ple

s

–

dis

posa

l of

was

te p

roduct

s

–

sele

ctin

g P

CR a

mplif

icat

ion

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

110

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of th

e w

ork

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

DN

A

sam

ple

s usi

ng P

oly

mer

ase

Chai

n R

eact

ion

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

anal

ytic

al

activi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

111

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.,

w

ork

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e/D

NA

conce

ntr

atio

n o

f la

bora

tory

sam

ple

req

uired

for

the

PCR a

mplif

ications

conduct

ed b

y th

e la

bora

tory

4

Know

how

to a

nal

yse

DN

A

sam

ple

s usi

ng P

oly

mer

ase

Chai

n R

eact

ion

(continued

)

4.1

D

escr

ibe

the

range

of sa

mple

s am

plif

ied,

the

conta

iner

s use

d f

or

sam

ple

sto

rage

and P

CR

amplif

icat

ion in t

he

labora

tory

, an

d o

ther

ess

ential

re

sourc

es n

eeded

for

each

inve

stig

ation

4.2

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

112

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.3

D

escr

ibe

the

mai

n fea

ture

s of th

e PC

R

ther

mocy

cler

, an

d t

he

under

lyin

g a

ctio

n o

f th

e re

agen

ts invo

lved

in t

he

react

ion m

ixtu

re

4.4

D

escr

ibe

the

various

PCR t

her

mocy

cler

oper

atio

ns

that

can

be

per

form

ed,

and t

he

met

hods

and

react

ion m

ixtu

res

use

d

4.5

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g p

rogra

ms

and m

ainte

nan

ce ite

ms

in t

he

ther

mocy

cler

4.6

Exp

lain

how

to inte

rpre

t a

PCR’s

vis

ual

dis

pla

y, a

nd

how

to u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.7

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.8

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

pro

cess

to b

e co

nduct

ed

4.9

D

escr

ibe

the

typic

al t

her

mocy

cler

fau

lts,

and t

he

actions

to b

e ta

ken if th

ey o

ccur

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f harm

ful ch

emic

als

and c

onta

min

ated

eq

uip

men

t

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

113

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


114


115

Unit 12: Maintaining cell lines for laboratory activities using cryogenic storage


QCF level: 3

Credit value: 6


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to maintain cell lines in cryogenic storage, in accordance with approved procedures. The learner is required to confirm that the required media are available, and that they have been prepared and stored in the way indicated by the manufacturer. In carrying out these activities, they will be expected to follow the correct procedures, whilst ensuring that a high standard of cleanliness and accuracy is maintained, with due regard for the risk of cross contamination of samples.

The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous materials and chemicals, ensuring that they are contained within designated areas whilst in use, and are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and grow cell lines in continuous or monolayer culture, choosing the required support medium, in line with safe working practices and approved procedures. They will then be required to harvest the cells and to determine the cell density, using a microscope or cell counting apparatus. They will make the required adjustments to cell density to obtain the predetermined value to give optimum viability after cryopreservation, in order to ensure that the output is to the required quality and accuracy, and that the cells remain viable after long term preservation. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the cell culture work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions, with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.


116

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying the appropriate procedures. They will have an understanding of the principles of cell culture and cryopreservation, the media and reagents used, and the factors affecting viability of cells during and after freezing, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out the preparation and disposal of dangerous materials and chemicals, and they will be aware of the risks involved with these materials, chemicals and associated equipment. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect yourself and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

117

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Mai

nta

in c

ell lin

es f

or

labora

tory

act

ivitie

s usi

ng

cryo

gen

ic s

tora

ge

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

handlin

g s

pec

imen

s and

equip

men

t

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves/

cryo

glo

ves

–

safe

ty g

lass

es/g

oggle

s/vi

sor

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

118

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.4

Car

ry o

ut

all of

the

follo

win

g f

or

cell

cryo

pre

serv

atio

n:

–

confirm

that

the

safe

ty c

abin

et,

cryo

pre

serv

atio

n

dev

ice

and s

tora

ge

unit a

re c

lean

and r

eady

for

use

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts a

nd r

eact

ion m

ixtu

res

to t

he

des

ired

lev

el o

f acc

ura

cy,

ensu

ring t

hat

ste

rilit

y is

mai

nta

ined

–

Prep

are

the

cell

susp

ensi

on a

t th

e co

rrec

t ce

ll den

sity

–

load

the

cell

susp

ensi

on into

am

poule

s, a

nd s

eal

corr

ectly

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

label

led

–

oper

ate

the

contr

olle

d fre

ezin

g d

evic

e until th

e co

rrec

t te

mper

ature

is

reach

ed

–

tran

sfer

fro

zen c

ulture

s to

long t

erm

sto

rage

–

chec

k th

e vi

abili

ty o

f fr

oze

n c

ulture

s af

ter

stora

ge

at

very

low

tem

per

atu

re

1.5

H

arve

st c

ells

in logar

ithm

ic g

row

th s

uitab

le for

cryo

gen

ic s

tora

ge

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

119

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Count

the

cells

in a

cel

l su

spen

sion,

ensu

ring t

hat

cl

um

ps

of

cells

are

bro

ken u

p,

and a

dju

st t

he

cell

count

to t

he

pre

-det

erm

ined

optim

um

for

reco

very

af

ter

free

zing

1.7

Pr

epare

the

free

zing m

edia

and r

e-su

spen

d c

ells

in

this

med

ium

1.8

Pu

t aliq

uots

of

cells

into

am

poule

s, a

nd s

eal an

d

label

them

appro

priate

ly

2

Mai

nta

in c

ell lin

es f

or

labora

tory

act

ivitie

s usi

ng

cryo

gen

ic s

tora

ge

(continued

)

2.1

Fr

eeze

culture

s in

am

poule

s, u

sing a

contr

olle

d

free

zing c

ham

ber

, in

the

corr

ect

man

ner

2.2

Rem

ove

fro

zen c

ells

to a

n a

ppro

priat

e lo

ng t

erm

cr

yopre

serv

atio

n c

ham

ber

2.3

M

onitor

the

cryo

pre

serv

atio

n u

nit,

as r

equired

, an

d

reple

nis

h liq

uid

nitro

gen

when

req

uired

2.4

Rem

ove

am

poule

s in

cry

opre

serv

atio

n c

ham

ber

st

ora

ge,

to c

hec

k vi

abili

ty o

f th

e ce

ll lin

e

2.5

Car

ry o

ut

all th

e fo

llow

ing:

–

calib

ration o

f m

icro

pip

ette

s

–

stora

ge

of

reag

ents

–

stora

ge

of

sam

ple

s

–

han

dlin

g a

nd d

isposa

l of dan

ger

ous

chem

ical

s

–

mea

suring c

ell den

sity

–

sele

ctin

g t

he

free

zing p

rogra

m

–

reco

rdin

g d

ata

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

120

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

2.7

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng b

oth

of th

e fo

llow

ing:

–

verb

al re

port

–

labora

tory

note

book

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to m

ainta

in c

ell

lines

for

labora

tory

ac

tivi

ties

usi

ng c

ryogen

ic

stora

ge

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

activi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce.

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

121

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is (

incl

udin

g low

te

mper

ature

sam

ple

s an

d liq

uid

nitro

gen

)

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

122

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to m

ainta

in c

ell

lines

for

labora

tory

ac

tivi

ties

usi

ng c

ryogen

ic

stora

ge

(continued

)

4.1

D

escr

ibe

the

min

imum

num

ber

/siz

e/vo

lum

e of

labora

tory

sam

ple

s re

quired

for

long t

erm

sto

rage

4.2

D

escr

ibe

the

range

of ce

ll lin

es a

nd c

onta

iner

s use

d

for

sam

ple

sto

rage

and a

nal

ysis

in t

he

labora

tory

, an

d o

ther

ess

ential

res

ourc

es n

eeded

for

each

in

vest

igation

4.3

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

4.4

D

escr

ibe

the

mai

n fea

ture

s of th

e cr

yopre

serv

atio

n

unit,

and t

he

under

lyin

g a

ctio

n o

f th

e re

agen

ts

invo

lved

in fre

ezin

g c

ells

and r

eact

ion m

ixtu

re

4.5

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

on t

he

contr

olle

d f

reez

ing s

tation,

and w

hat

to d

o if an

er

ror

mes

sage

is d

ispla

yed

4.6

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t if t

he

free

zing r

un h

as b

een s

topped

bef

ore

com

ple

tion o

f th

e oper

atio

n

4.7

Exp

lain

how

to c

hec

k th

at t

he

free

zing a

nd s

tora

ge

of th

e ce

ll lin

e has

bee

n s

ucc

essf

ul

4.8

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

act

ivitie

s to

be

carr

ied

out

4.9

D

escr

ibe

the

pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f harm

ful m

ater

ials

, ch

emic

als

and

conta

min

ate

d e

quip

men

t

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

123

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


124


125

Unit 13: Culturing/fermenting cells for laboratory activities using controlled fed batch or continuous culture fermentation

Unit reference number: Y/601/8193

QCF level: 3

Credit value: 12


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory culturing/fermentation of cells using a batch, fed batch or continuous culture fermenter, in accordance with approved procedures. The learner is required to confirm that the required media, reagents and components are available and have been stored in the way indicated by the supplier. In carrying out these activities, they will be expected to follow the correct procedures, whilst ensuring that a high standard of cleanliness is maintained with due regard for the risk of cross contamination of samples. The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous cultures, materials and chemicals, ensuring that they are contained within designated areas while in use and are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the fermenter, choosing the appropriate program, in line with safe working practices and approved procedures. They are also expected to monitor and analyse operations and, where necessary, make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the fermentation work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying fermentation and process control procedures. They will have an


126

understanding of the fermentation reaction and the reagents used, in relation to control of temperature, pH, pO2, agitation and foaming in the reaction vessel, in order to produce and accumulate an end product.

The learner will understand the safety precautions required when carrying out the preparation and disposal of dangerous materials and chemicals, and the will be aware of the risks involved in handling these substances. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

127

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Culture

/fer

men

t ce

lls f

or

labora

tory

act

ivitie

s usi

ng

contr

olle

d f

ed b

atch

or

continuous

culture

fe

rmen

tation

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

handlin

g s

pec

imen

s and

equip

men

t, a

nd a

pply

saf

e w

ork

ing p

ract

ices

at

all

tim

es

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

128

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.4

Car

ry o

ut

all of

the

follo

win

g f

erm

enta

tion

oper

atio

ns:

–

confirm

that

the

equip

men

t is

rea

dy

for

the

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts a

nd r

eact

ion m

ixtu

res

to t

he

des

ired

lev

el o

f acc

ura

cy

–

dis

man

tle,

auto

clav

e an

d r

eass

emble

the

ferm

ente

r on t

he

contr

ol bas

e

–

calib

rate

and p

repar

e pro

bes

for

pH

and p

O2

–

oper

ate

the

ferm

ente

r pro

gra

m,

and r

ecord

and

eval

uat

e dat

a during f

erm

enta

tion

–

use

the

equip

men

t so

ftw

are

to c

ontr

ol th

e fe

rmen

tation u

ntil th

e cr

itic

al e

nd p

oin

t is

re

ached

–

har

vest

the

des

ired

cel

ls/c

om

ponen

ts o

f th

e fe

rmen

tation

–

dis

infe

ct t

he

com

ponen

ts o

f th

e fe

rmen

ter,

and

clea

n t

he

equip

men

t re

ady

for

use

agai

n

1.5

Pr

epare

the

ferm

ente

r fo

r fe

rmen

tation,

in

acco

rdan

ce w

ith e

stablis

hed

pro

cedure

s

1.6

In

ocu

late

the

ferm

enta

tion m

ediu

m w

ith a

sta

rter

cu

lture

, an

d m

onitor

the

culture

purity

and g

row

th

rate

during t

he

gro

wth

sta

ge

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

129

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.7

M

onitor

the

ferm

enta

tion u

sing t

he

soft

ware

, m

akin

g a

dditio

ns

to t

he

ferm

ente

r ve

ssel

as

det

aile

d in t

he

rele

vant

pro

cedure

s, w

hen

nec

essa

ry

2

Culture

/fer

men

t ce

lls f

or

labora

tory

act

ivitie

s usi

ng

contr

olle

d f

ed b

atch

or

continuous

culture

fe

rmen

tation (

continued

)

2.1

Tak

e sa

mple

s to

monitor

the

pro

gre

ss o

f ce

ll gro

wth

and p

roduct

ion o

f m

etabolit

es

2.2

H

arve

st t

he

culture

at

the

required

gro

wth

phas

e/ce

ll den

sity

/met

abolit

e pro

duct

ion

2.3

D

ispose

of

spen

t m

ater

ials

in a

ccord

ance

with

dep

artm

enta

l hea

lth a

nd s

afe

ty p

roce

dure

s

2.4

D

isin

fect

and c

lean

the

ferm

ente

r re

ady

for

nex

t use

, in

acc

ord

ance

with t

he

man

ufa

cture

r’s

guid

elin

es

2.5

Car

ry o

ut

all of

the

follo

win

g:

–

calib

ration o

f m

icro

pip

ette

s

–

stora

ge

of

reag

ents

–

stora

ge

of

sam

ple

s

–

han

dlin

g a

nd d

isposa

l of dan

ger

ous

chem

ical

s

–

sele

ctin

g/r

unnin

g t

he

pro

gra

m

–

usi

ng c

orr

ect

auto

clave

cyc

le

–

reco

rdin

g d

ata

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

130

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

com

pute

r re

adout

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

elec

tronic

mai

l

3

Know

how

to

culture

/fer

men

t ce

lls f

or

labora

tory

act

ivitie

s usi

ng

contr

olle

d f

ed b

atch

or

continuous

culture

fe

rmen

tation

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

ferm

enta

tion a

ctiv

itie

s

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

131

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.,

w

ork

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e/ce

ll den

sity

of

any

star

ter

culture

req

uired

for

the

ferm

enta

tion

inve

stig

ations

conduct

ed b

y th

e la

bora

tory

3.1

2

Des

crib

e th

e ra

nge

and c

onditio

n o

f es

sential

re

sourc

es n

eeded

for

each

inve

stig

ation

3.1

3

Des

crib

e th

e im

port

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

132

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to

culture

/fer

men

t ce

lls f

or

labora

tory

act

ivitie

s usi

ng

contr

olle

d f

ed b

atch

or

continuous

culture

fe

rmen

tation (

continued

)

4.1

D

escr

ibe

the

mai

n fea

ture

s of th

e fe

rmen

ter,

and

the

under

lyin

g a

ctio

n o

f th

e ce

lls,

med

ia a

nd

reag

ents

invo

lved

in t

he

ferm

enta

tion r

eact

ion

vess

el

4.2

D

escr

ibe

the

various

ferm

enta

tion o

per

atio

ns

that

ca

n b

e per

form

ed,

and t

he

cells

, m

ethods

and

react

ion m

ixtu

res

use

d

4.3

Exp

lain

how

to d

ism

antle

the

ferm

ente

r, c

alib

rate

pro

bes

and s

terilis

e co

mponen

ts b

efore

co

mm

enci

ng fer

men

tation

4.4

Exp

lain

how

to a

pply

good a

septic

tech

niq

ues

, an

d

how

to r

eass

emble

the

ster

ilise

d fer

men

ter

prior

to

the

culture

fer

men

tation a

ctiv

itie

s

4.5

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g p

rogra

ms

and m

ainte

nan

ce ite

ms

in t

he

ferm

ente

r

4.6

Exp

lain

how

to inte

rpre

t th

e fe

rmen

ter

visu

al

dis

pla

y, a

nd h

ow

to u

nder

stan

d t

he

various

mes

sages

dis

pla

yed

4.7

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.8

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m if th

e fe

rmen

tation h

as

bee

n s

topped

bef

ore

com

ple

tion o

f th

e pro

gra

m

4.9

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

ferm

enta

tion a

ctiv

itie

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

133

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

0

Des

crib

e th

e ty

pic

al f

erm

enta

tion fau

lts,

and t

he

actions

to b

e ta

ken if th

ey o

ccur

4.1

1

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f harm

ful cu

lture

s and b

i-pro

duct

s an

d

conta

min

ate

d e

quip

men

t

4.1

2

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


134


135

Unit 14: Maintaining cell lines for laboratory activities using sub-culture

Unit reference number: D/601/8194

QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to maintain cell lines by regular sub-culture, in accordance with approved procedures. The learner is required to confirm that the necessary media are available, and that they have been prepared and stored in the way indicated by the manufacturer. In carrying out these activities, they will be expected to follow the correct procedures, whilst ensuring that a high standard of cleanliness and accuracy is maintained with due regard for the risk of cross contamination of samples. The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous materials and chemicals, ensuring that they are contained within designated areas whilst in use and are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

They will be required to maintain cell lines in batch or continuous culturing, in either monolayer or suspension culture, choosing the required support medium, in line with safe working practices and approved procedures. They will add agents to break any adhesion bonds between cells, and will determine the cell density using a microscope and cell counting apparatus. They will make the required adjustments to cell density to obtain the predetermined value for further culture work, in order to ensure that the output is to the required quality and accuracy, and that the cells remain viable and continue to grow. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

Their responsibilities will require them to comply with standard operating procedures for the cell culture work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

Their underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable they to adopt an informed approach to


136

procedures. They will have an understanding of the principles of cell culture and sub-culture, the media and reagents used, the factors affecting viability, and likely sources and signs of contamination, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

They will understand the safety precautions required when carrying out the preparation and disposal of dangerous materials and chemicals, and they will be aware of the risks involved with these materials and chemicals, and with the associated equipment. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect yourself and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

137

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Mai

nta

in c

ell lin

es f

or

labora

tory

act

ivitie

s usi

ng

sub-c

ulture

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s/sa

fety

vis

or

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Apply

saf

e w

ork

ing p

ract

ices

at

all tim

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

138

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g f

or

cell

scal

e-up

activi

ties

:

–

confirm

that

the

safe

ty c

abin

et,

med

ia a

nd

equip

men

t ar

e cl

ean a

nd r

eady

for

use

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts a

nd r

eact

ion m

ixtu

res

to t

he

des

ired

lev

el o

f acc

ura

cy e

nsu

ring s

terilit

y is

m

ainta

ined

–

pre

par

e a

cell

susp

ensi

on a

t th

e co

rrec

t ce

ll den

sity

–

sub-c

ulture

the

cell

susp

ensi

on into

cle

an c

ulture

ve

ssel

s an

d a

dd fre

sh m

ediu

m

–

incu

bat

e th

e ce

ll cu

lture

s at

the

corr

ect

tem

per

ature

, hum

idity

and C

O2 c

once

ntr

atio

n

–

chec

k gro

wth

and s

terilit

y of cu

lture

s on a

dai

ly

bas

is

1.6

Ensu

re t

hat

sam

ple

s, m

edia

and r

eagen

ts a

re

store

d c

orr

ectly

and a

re m

ain

tain

ed a

t th

e co

rrec

t te

mper

ature

during u

se

1.7

W

ash m

edia

fro

m t

he

cells

, an

d a

dd a

n a

ppro

priat

e ag

ent

to b

reak

cel

l adhes

ion,

wher

e nec

essa

ry

1.8

Pe

rform

cel

l co

unts

on a

cel

l su

spen

sion,

ensu

ring

that

clu

mps

of

cells

are

bro

ken u

p a

nd a

suitab

le

dilu

tion is

use

d,

and a

dju

st t

he

cell

count,

wher

e nec

essa

ry,

bef

ore

div

isio

n into

sub-c

ulture

ves

sels

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

139

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Mai

nta

in c

ell lin

es f

or

labora

tory

act

ivitie

s usi

ng

sub-c

ulture

(co

ntinued

)

2.1

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

quip

men

t fa

ults

and r

eport

those

that

cannot

be

reso

lved

2.2

Pre

pare

fre

sh g

row

th m

edia

, and r

e-su

spen

d c

ells

in

acc

ord

ance

with r

equirem

ents

2.3

M

easu

re o

ut

aliq

uots

of

the

cells

into

fre

sh c

ulture

ve

ssel

s, label

them

corr

ectly

and a

dd m

ore

med

ium

to

ach

ieve

the

final

volu

me

for

the

reco

mm

ended

ve

ssel

2.4

Set

incu

bation c

onditio

ns,

monitor

cell

gro

wth

and

ensu

re t

hat

the

culture

s ar

e fr

ee fro

m

conta

min

ation

2.5

Car

ry o

ut

all of

the

follo

win

g:

–

calib

ration o

f m

icro

pip

ette

s

–

stora

ge

of

reag

ents

–

stora

ge

of

sam

ple

s

–

han

dlin

g a

nd d

isposa

l of dan

ger

ous

chem

ical

s

–

mea

suring c

ell den

sity

–

incu

bat

ing c

ulture

s

–

reco

rdin

g d

ata

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

140

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng b

oth

:

–

verb

al re

port

–

labora

tory

note

book

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to m

ainta

in c

ell

lines

for

labora

tory

ac

tivi

ties

usi

ng s

ub-

culture

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

activi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

141

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

4

Know

how

to m

ainta

in c

ell

lines

for

labora

tory

ac

tivi

ties

usi

ng s

ub-

culture

(co

ntinued

)

4.1

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

4.2

D

escr

ibe

the

limits

of th

eir

ow

n a

uth

ority

and t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

4.3

D

escr

ibe

the

min

imum

num

ber

/siz

e/vo

lum

e of

sam

ple

s re

quired

for

labora

tory

exp

erim

enta

tion

4.4

D

escr

ibe

the

range

of ce

ll lin

es,

the

conta

iner

s use

d

for

cell

gro

wth

and s

ub-c

ulture

in t

he

labora

tory

, an

d o

ther

ess

ential

res

ourc

es n

eeded

for

each

ac

tivi

ty

4.5

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

for

dea

ling w

ith p

ote

ntial

ly d

anger

ous

cell

lines

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

142

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.6

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

4.7

D

escr

ibe

the

mai

n fea

ture

s of th

e ce

ll lin

e, a

nd t

he

under

lyin

g a

ctio

n o

f th

e m

edia

and r

eagen

ts

invo

lved

in c

ell adhes

ion a

nd d

isru

ption,

and t

he

gro

wth

of

cells

in c

ulture

4.8

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

act

ivitie

s bei

ng

under

take

n

4.9

D

escr

ibe

the

pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f harm

ful m

ater

ials

and c

hem

ical

s an

d

conta

min

ate

d e

quip

men

t

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


143

Unit 15: Measuring, weighing and preparing compounds and solutions for laboratory use


QCF level: 3

Credit value: 16


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to measure, weigh and prepare compounds and solutions for laboratory investigations. Prior to undertaking the laboratory activity, and in accordance with approved procedures and practices, the learner will be required to carry out all the necessary preparations, within the scope of their responsibility. This may include preparing the work area and ensuring that it is in a safe condition to carry out the intended activities, and ensuring that any materials, equipment or other resources required are available and are in a safe and usable condition. The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). The learner will also be required to present records and details of their laboratory work to the appropriate people.

On completion of the laboratory activity, the learner will be required to return their immediate work area to an acceptable condition before undertaking further work. This may involve putting processed paperwork in the correct location, returning and/or storing any materials and equipment in the correct area, identifying any waste and arranging for its disposal, and reporting any defects or damage to the materials and equipment used.

The learner’s responsibilities will require them to comply with organisational policy and procedures for the measuring, weighing and preparations undertaken, and to report any problems with the activities, materials or equipment that they cannot personally resolve or that are outside their permitted authority, to the relevant people. The learner will work with a minimum of supervision, either on their own or as part of a team, whilst taking responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will provide a good understanding of their work, and will provide an informed approach to measuring, weighing and preparing compounds and solutions in a laboratory environment. The learner will understand the importance of doing this work efficiently and effectively, and will know what to consider when preparing and tidying up the work area before and after the measuring, weighing and preparation activities. The learner will also know how to deal with problems, and how to


144

achieve their work objectives and targets, in adequate depth to provide a sound basis for carrying out the activities safely and correctly.

The learner will understand the safety precautions required when carrying out laboratory activities. The learner will be required to demonstrate safe working practices throughout, and will understand the responsibility they owe to themselves and others in the workplace.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

145

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Mea

sure

, w

eigh a

nd

pre

par

e co

mpounds

and

solu

tions

for

labora

tory

use

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g m

ater

ials

1.3

U

se t

hre

e of th

e fo

llow

ing t

ypes

of pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

–

face

mask

–

glo

ves

–

safe

ty g

lass

es

–

oth

er (

ple

ase

spec

ify)

1.4

U

se lab

ora

tory

sca

les

for

accu

rate

ly w

eighin

g o

ut

mat

eria

ls,

usi

ng m

etric/

imper

ial m

easu

res

1.5

Car

ry o

ut

wei

ghin

g a

ctiv

itie

s usi

ng b

ala

nce

s (s

cale

s),

usi

ng t

wo o

f th

e fo

llow

ing a

ccura

cies

:

–

gra

ms

–

mill

igra

ms

–

mic

rogra

ms

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

146

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

M

easu

re o

ut

aliq

uots

of

solu

tions,

usi

ng f

our

of th

e fo

llow

ing:

–

auto

mat

ed p

ipet

tes

–

gra

duat

ed/b

ulb

pip

ette

s

–

syringes

–

gra

duat

ed c

ylin

der

s/bea

kers

/tubes

–

bure

ttes

–

volu

met

ric

flask

s

–

oth

er (

ple

ase

spec

ify)

1.7

Acc

ura

tely

mea

sure

pH

and c

onduct

ivity

of

solu

tions

in t

he

labora

tory

, usi

ng c

orr

ectly

calib

rate

d m

eter

s

1.8

M

easu

re o

ut

aliq

uots

of liq

uid

s in

to t

ubes

and

mic

rotr

ays

for

labora

tory

use

and a

nal

ysis

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

147

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Mea

sure

, w

eigh a

nd

pre

par

e co

mpounds

and

solu

tions

for

labora

tory

use

(co

ntinued

)

2.1

M

easu

re liq

uid

s an

d s

olid

s fo

r la

bora

tory

use

and

anal

ysis

2.2

M

easu

re p

H a

nd/o

r co

nduct

ivity,

usi

ng t

wo o

f th

e fo

llow

ing:

–

han

dhel

d p

H m

eter

–

ben

ch t

op p

H m

eter

–

com

bin

ed p

H/c

onduct

ivity

met

er

–

conduct

ivity

met

er

–

oth

er (

ple

ase

spec

ify)

2.3

Cal

ibra

te o

r ch

eck

the

calib

ration for

two o

f th

e fo

llow

ing:

–

pH

met

er

–

bal

ance

–

conduct

ivity

met

er

–

pip

ette

s

–

oth

er(p

lease

spec

ify)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

148

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.4

Cal

cula

te t

he

conce

ntr

atio

ns

of

solu

tions,

the

amounts

and v

olu

mes

req

uired

, usi

ng four

of th

e fo

llow

ing:

–

mole

s per

litre

–

gra

ms

per

litre

–

par

ts p

er m

illio

n

–

mas

s per

cent

–

oth

er (

ple

ase

spec

ify)

2.5

M

ake

up k

now

n v

olu

mes

of

solu

tions

to a

spec

ifie

d

conce

ntr

atio

n,

usi

ng b

oth

of

the

follo

win

g:

–

by

mea

suri

ng a

nd d

isso

lvin

g t

he

corr

ect

am

ount

of

solu

te in t

he

corr

ect

volu

me

of dilu

ent/

solv

ent

–

by

dilu

tion fro

m a

conce

ntr

ate

d s

tock

solu

tion

2.6

W

eigh a

nd p

repare

thre

e of

the

follo

win

g t

ypes

of

com

pound o

r so

lution:

–

pow

der

s/gra

nula

tions

that

do n

ot

read

ily lose

or

gai

n w

eight

(mois

ture

or

solv

ent)

–

solid

s th

at r

eadily

lose

or

gai

n w

eight

(mois

ture

or

solv

ent)

–

liquid

sam

ple

s (b

y diffe

rence

)

–

liquid

sam

ple

s (d

irec

t)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

149

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s.

2.8

Rec

ord

det

ails

of

work

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Pl

us

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

(e.

g.

labora

tory

note

book)

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to m

easu

re,

wei

gh a

nd p

repar

e co

mpounds

and s

olu

tions

for

labora

tory

use

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

150

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

spec

imen

s/sa

mple

s

3.5

D

escr

ibe

the

import

ance

of

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

atio

nal

or

labora

tory

num

ber

s

3.6

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

hei

r lin

ks

with t

he

rest

of

the

org

anis

ation

3.7

D

escr

ibe

the

limits

of th

eir

ow

n a

uth

ority

and t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.8

Exp

lain

how

to c

alcu

late

mass

/mole

cal

cula

tions

in

met

ric

and/o

r im

per

ial m

easu

res

3.9

Exp

lain

how

to s

elec

t th

e appro

priat

e bal

ance

and

scal

e fo

r le

ss t

han

100m

g,

100m

g t

o 5

g,

and 5

g

and a

bove

3.1

0

Exp

lain

how

to c

hec

k th

at a

pip

ette

is

clea

n,

dry

, fr

ee o

f ch

ips

and r

eady

for

use

4

Know

how

to m

easu

re,

wei

gh a

nd p

repar

e co

mpounds

and s

olu

tions

for

labora

tory

use

(c

ontinued

)

4.1

Exp

lain

how

to c

hec

k th

e ca

libra

tion o

n a

pip

ette

4.2

Exp

lain

how

to c

alib

rate

and c

hec

k th

e ca

libra

tion

on a

pH

met

er

4.3

Exp

lain

how

to c

alib

rate

and c

hec

k th

e ca

libra

tion

on a

bal

ance

4.4

Exp

lain

how

to c

alib

rate

and c

hec

k th

e ca

libra

tion

on a

conduct

ivity

met

er

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

151

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.5

Exp

lain

how

to m

easu

re a

nd w

eigh s

olid

s an

d

liquid

s fo

r la

bora

tory

use

4.6

Exp

lain

how

to c

onve

rt b

etw

een d

iffe

rent

units

of

conce

ntr

atio

n (

such

as

mole

s/lit

re,

gra

ms/

litre

, per

cent

mas

s per

volu

me

and p

arts

per

mill

ion)

4.7

Exp

lain

how

to c

alcu

late

dilu

tion fact

ors

and d

ilution

volu

mes

to m

ake

solu

tions

from

conce

ntr

ated

sto

ck

solu

tions

4.8

D

escr

ibe

the

pH

sca

le a

s a

logarith

mic

sca

le for

the

mea

sure

men

t of th

e ac

idity

of aqueo

us

solu

tions,

an

d t

he

import

ance

of pH

to b

iolo

gic

al sy

stem

s an

d

pro

cess

es

4.9

Exp

lain

how

to c

hoose

the

appro

priat

e m

easu

ring

equip

men

t fo

r th

e sc

ale,

acc

ura

cy a

nd p

reci

sion

required

for

the

task

4.1

0

Exp

lain

how

to c

lean

and m

ain

tain

the

pip

ette

s,

bal

ance

s, p

H m

eter

pro

bes

and c

onduct

ivity

met

er

pro

bes

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


152


153

Unit 16: Separating samples for laboratory activities using centrifugation


QCF level: 3

Credit value: 3


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory centrifugation, using low speed bench-top centrifuges and high speed refrigerated ultracentrifuges, in accordance with approved procedures. The learner is required to confirm that the necessary rotors and adaptors are available, and that they have been cleaned and stored in the way indicated by the supplier. In carrying out these activities, they will be expected to follow the correct procedures, whilst ensuring that a high standard of cleanliness and accuracy is maintained, with due regard for the risk of production of aerosols and damage to the instrument due to poor laboratory cleanliness and care. The learner will be required to work to the relevant standard operation procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous materials, ensuring that they are contained within designated areas while in use and that they are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the centrifuges, choosing the required rotors, buckets and accessories, in line with safe working practices and approved procedures, so that the instrument is safe and the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the centrifugation work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to procedures. They will have an understanding of the principles of centrifugation, the use and limitations of the sample vessels, how to load and balance tubes and load the instrument. They will also know about the


154

rotors, adaptors and accessories used, and the use of centrifugation as an end product or as a preparative technique for further analysis, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification. They will have an understanding of measurement of speed in revolutions per minute (rpm), and the conversion to relative centrifugal force.

The learner will understand the safety precautions required when carrying out the preparation and disposal of dangerous chemicals, and the risks involved with these chemicals. They will also understand the safety requirements of the equipment, particularly with the production of aerosols and with the effects of corrosive materials on the long term safety and integrity of centrifuge rotors. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

155

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Sep

arat

e sa

mple

s fo

r la

bora

tory

act

ivitie

s usi

ng

centr

ifugation

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

W

ear

two o

f th

e fo

llow

ing t

ypes

of pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s/sa

fety

vis

or

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Set

up t

he

equip

men

t an

d e

nsu

re t

hat

it

is r

eady

for

the

centr

ifugin

g a

ctiv

itie

s to

be

carr

ied o

ut

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

156

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

In

car

ryin

g o

ut

thei

r ac

tivi

ties

, en

sure

all

of th

e fo

llow

ing:

–

the

centr

ifuge

is c

lean a

nd r

eady

for

use

–

all sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and

are

funct

ionin

g c

orr

ectly

–

the

roto

rs,

buck

ets

and c

entr

ifuge

vess

els

are

com

patible

with t

he

centr

ifuge

oper

atio

n

–

all sp

ecim

ens

are

corr

ectly

label

led

–

lids

are

tight

and s

am

ple

s ar

e lo

aded

dia

met

rica

lly a

nd e

venly

–

the

run p

ara

met

ers

on t

he

centr

ifuge

are

com

patible

with t

he

roto

r, b

uck

ets,

adap

tors

and

vess

els

use

d

–

sam

ple

s hav

e no lea

ks o

r sp

ills

when

rem

ove

d

from

the

centr

ifuge

1.6

Car

ry o

ut

all of

the

follo

win

g:

–

load

the

roto

r, a

nd a

dd b

uck

ets

and a

dap

tors

–

load

and b

alan

ce s

am

ple

tubes

–

set

the

run p

aram

eter

s

–

han

dle

spill

s an

d lea

kages

–

rem

ove

and c

lean

roto

rs,

buck

ets

and a

dapto

rs

–

store

roto

rs

–

reco

rd d

ata

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

157

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.7

Sep

ara

te s

am

ple

s fo

r la

bora

tory

act

ivitie

s, u

sing

both

of

the

follo

win

g:

–

low

spee

d b

ench

-top c

entr

ifuges

–

hig

h s

pee

d r

efriger

ated

ultra

centr

ifuges

1.8

O

per

ate

the

centr

ifuge

contr

ols

saf

ely

and c

orr

ectly,

in

lin

e w

ith o

per

ational

pro

cedure

s

2

Sep

arat

e sa

mple

s fo

r la

bora

tory

act

ivitie

s usi

ng

centr

ifugation (

continued

)

2.1

Cen

trifuge

sam

ple

s to

the

required

qualit

y an

d

within

the

spec

ifie

d d

imen

sional

acc

ura

cy

2.2

Car

ry o

ut

qual

ity

chec

ks w

hen

rem

ovi

ng s

ample

s fr

om

the

centr

ifuge

2.3

D

eal pro

mptly

and e

ffec

tive

ly w

ith p

roble

ms

within

th

eir

contr

ol an

d r

eport

those

that

can

not

be

solv

ed

2.4

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e ce

ntr

ifugin

g a

ctiv

itie

s

2.5

Conduct

all

the

follo

win

g m

ain

tenan

ce a

ctiv

itie

s on

the

centr

ifuge:

–

rem

ove

and c

lean

buck

ets

and a

dap

tors

–

rem

ove

the

roto

rs a

nd c

lean

with t

he

man

ufa

cture

r’s

reco

mm

ended

cle

aner

–

rem

ove

roto

rs a

nd c

lean

and lubrica

te r

oto

r pin

s

–

report

any

signs

of w

ear,

dam

age

or

corr

osi

on

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

158

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of

work

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

ver

bal

rep

ort

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to s

epar

ate

sam

ple

s fo

r la

bora

tory

ac

tivi

ties

usi

ng

centr

ifugation

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

centr

ifugin

g

activi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

159

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

and m

axi

mum

siz

e/vo

lum

e of la

bora

tory

sam

ple

req

uired

for

the

centr

ifugat

ion

oper

ations

conduct

ed b

y th

e la

bora

tory

4

Know

how

to s

epar

ate

sam

ple

s fo

r la

bora

tory

ac

tivi

ties

usi

ng

centr

ifugation (

continued

)

4.1

D

escr

ibe

the

range

of sa

mple

s an

alys

ed,

the

conta

iner

s use

d f

or

sam

ple

sto

rage

and a

nal

ysis

in

the

labora

tory

, an

d o

ther

ess

ential

res

ourc

es

nee

ded

for

each

inve

stig

ation

4.2

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

160

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.3

D

escr

ibe

the

mai

n fea

ture

s of th

e ce

ntr

ifuge,

and

its

use

s an

d lim

itat

ions

4.4

D

escr

ibe

the

rela

tionsh

ip b

etw

een r

evolu

tions

per

m

inute

(RPM

) an

d r

elat

ive

centr

ifugal fo

rce

(RC

F [g

]),

and t

he

calc

ula

tions

to inte

rconve

rt t

hes

e va

lues

4.5

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.6

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

centr

ifugat

ion t

o b

e co

nduct

ed

4.7

D

escr

ibe

the

typic

al c

entr

ifugation fau

lts

and

pro

ble

ms,

and t

he

actions

to b

e ta

ken if th

ey o

ccur

4.8

D

escr

ibe

the

routine

clea

nin

g a

nd s

tora

ge

pro

cedure

for

the

centr

ifuge,

roto

r an

d a

dapto

rs

4.9

D

escr

ibe

the

pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f bre

akag

es o

f co

nta

min

ated

equip

men

t or

spill

s of

har

mfu

l ch

emic

als

and m

ater

ials

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

centr

ifuge

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

161

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


162


163

Unit 17: Analysing laboratory samples using light microscopy


QCF level: 3

Credit value: 6


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using a light microscope, in accordance with approved procedures. The learner is required to confirm that the required reagents are available, and has been stored in the way indicated by the supplier, and that the microscope is set up and used in line with the manufacturer’s recommendations and the standard operating procedure. In carrying out these activities, they will be expected to follow the correct protocols for ensuring that a high standard of cleanliness and accuracy is maintained, with due regard for the risk of cross contamination of samples, the introduction of aberrations, and damage to the instrument resulting from misuse or poor maintenance.

The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous biological materials and chemicals, ensuring that they are contained within designated areas whilst in use and that they are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to prepare biological materials for viewing, and to set up and operate the microscope, choosing the appropriate microscope configuration, and attaching any additional accessories to view and record samples, as applicable. They will also be required to make the necessary adjustments, in line with safe working practices and approved procedures and, when necessary, to produce a permanent record of the image by photography or LIMS, in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the microscopy work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.


164

The learner will be expected to maintain the microscope in working order and to follow simple procedures to replace used or worn out components and reagents, as required.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying the appropriate procedures. They will choose the correct program to record and interpret the images viewed, as an end product or as a preparative technique for further analysis. They will have an understanding of the principles of light microscopy, the set-up, use and care of lenses used, and the different methods of specimen illumination, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out the preparation and disposal of biological material. They will also understand the safety precautions required when using dangerous chemicals, and the risks involved with these chemicals and with the equipment. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace and outside.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

165

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng lig

ht

mic

rosc

opy

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

U

se t

hre

e of th

e fo

llow

ing t

ypes

of pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s/sa

fety

vis

or

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Apply

saf

e w

ork

ing p

ract

ices

at

all tim

es

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

166

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g f

or

light

mic

rosc

opy:

–

confirm

that

the

mic

rosc

ope

and a

llied

eq

uip

men

t is

cle

an a

nd r

eady

for

use

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

pre

par

e re

agen

ts a

nd r

eact

ion m

ixtu

res

to t

he

des

ired

lev

el o

f acc

ura

cy

–

pre

par

e bio

logic

al s

pec

imen

s fo

r vi

ewin

g,

by

stai

nin

g o

r ad

ditio

n o

f sp

ecific

dye

s

–

mount

spec

imen

s onto

the

mic

rosc

ope,

and

sele

ct t

he

corr

ect

oper

atin

g p

aram

eter

s fo

r th

e m

icro

scope

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

label

led

with r

espec

t to

thei

r origin

and s

ubse

quen

t tr

eatm

ent

–

set

up a

nd o

per

ate

the

mic

rosc

ope,

follo

win

g t

he

def

ined

oper

atin

g p

roce

dure

s; c

hoose

the

required

pro

gra

m a

nd a

pply

safe

work

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

–

focu

s th

e sp

ecim

en,

usi

ng t

he

required

len

s to

giv

e gre

ate

st r

esolu

tion o

f th

e sa

mple

, an

d

reco

rd d

ata

as

a dra

win

g,

photo

gra

ph o

r in

a

LIM

S,

in a

ccord

ance

with d

epar

tmen

tal

pro

cedure

s

–

dis

pose

of

or

store

use

d m

ate

rial an

d

conta

min

ate

d P

PE,

in a

ccord

ance

with s

afe

dep

artm

enta

l oper

atin

g p

roce

dure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

167

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Fo

llow

the

def

ined

pro

cedure

for

pre

par

atio

n o

f bio

logic

al/c

om

pound m

ater

ial

1.7

Car

ry o

ut

all of

the

follo

win

g:

–

calib

ration o

f m

icro

pip

ette

s

–

stora

ge

of

reag

ents

–

stora

ge

of

sam

ple

s

–

han

dlin

g a

nd d

isposa

l of dan

ger

ous

chem

ical

s

–

sett

ing u

p a

nd c

lean

ing t

he

equip

men

t

–

pre

par

ing a

nd s

tain

ing b

iolo

gic

al sa

mple

s

–

reco

rdin

g d

ata

–

mai

nta

inin

g e

quip

men

t bet

wee

n u

ses

2

Anal

yse

labora

tory

sa

mple

s usi

ng lig

ht

mic

rosc

opy

(continued

)

2.1

Lo

ad s

ample

s fo

r an

aly

sis

on t

o t

he

mic

rosc

ope

care

fully

, usi

ng low

pow

er,

ensu

ring t

hat

the

fiel

d

of

view

is

focu

sed c

aref

ully

without

dam

age

to t

he

sam

ple

or

obje

ctiv

e le

nse

s

2.2

U

se s

tandard

siz

e m

ark

ers

and s

elec

tive

sta

ins

or

pro

bes

to m

easu

re,

quan

tify

and iden

tify

sam

ple

s

2.3

M

easu

re,

quan

tify

and iden

tify

sam

ple

s, u

sing t

hre

e of th

e fo

llow

ing:

–

stai

nin

g p

roce

dure

s

–

counting c

ham

ber

–

counting flu

ore

scen

ts

–

oth

er d

yes

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

168

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.4

Sto

re p

repar

ativ

e sa

mple

s in

the

corr

ect

loca

tion

for

stora

ge,

furt

her

pre

par

atio

n o

r an

alys

is

2.5

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done

to a

uth

orise

d p

eople

, in

acc

ord

ance

with

dep

artm

enta

l an

d o

rgan

isat

ional

pro

cedure

s

2.6

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

169

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

light

mic

rosc

opy

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

anal

ytic

al

activi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

and p

repar

ing labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

170

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

mic

rosc

ope

slid

e pre

par

ation a

nd inve

stig

ations

conduct

ed b

y th

e la

bora

tory

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

the

conta

iner

s use

d f

or

sam

ple

sto

rage

and a

nal

ysis

in

the

labora

tory

, an

d o

ther

ess

ential

res

ourc

es

nee

ded

for

each

inve

stig

ation

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

light

mic

rosc

opy

(continued

)

4.1

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

4.2

D

escr

ibe

the

mai

n f

eatu

res

of th

e lig

ht

mic

rosc

ope;

how

to c

alc

ula

te a

nd r

ecord

magnific

atio

n,

and t

he

diffe

rence

bet

wee

n m

agnific

atio

n a

nd r

esolu

tion

4.3

D

escr

ibe

the

under

lyin

g a

ctio

n o

f th

e re

agen

ts,

stai

ns

and d

yes

invo

lved

in t

he

pro

cess

of

sam

ple

pre

par

ation,

and t

he

expec

ted o

utc

om

e of

each

tr

eatm

ent

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

171

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.4

D

escr

ibe

the

various

types

of

mic

rosc

ope

availa

ble

in

the

labora

tory

, th

e oper

ations

that

can b

e per

form

ed w

ith e

ach

and t

he

acco

mpan

ying s

am

ple

pre

par

ation

4.5

D

escr

ibe

the

clea

nin

g a

nd m

ainte

nan

ce o

f m

icro

scopes

aft

er u

se,

and t

he

har

mfu

l ef

fect

s of

usi

ng inco

rrec

t cl

eanin

g m

ater

ials

4.6

D

escr

ibe

the

com

mon e

rrors

that

may

occ

ur

in

sam

ple

pre

par

atio

n,

and h

ow

to o

verc

om

e or

avoid

th

ose

err

ors

4.7

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

work

to b

e ca

rrie

d o

ut

4.8

D

escr

ibe

the

typic

al m

icro

scope

faults

and

mai

nte

nan

ce p

roce

dure

s, a

nd t

he

actions

to b

e ta

ken if fa

ults

occ

ur

4.9

D

escr

ibe

the

pro

cedure

to b

e fo

llow

ed w

hen

dis

posi

ng o

f harm

ful ch

emic

als

and c

onta

min

ated

eq

uip

men

t

4.1

0

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

4.1

1

Des

crib

e th

e ty

pes

of st

ainin

g p

roce

ss u

sed,

and

the

range

of dye

s ava

ilable

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

172

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


173

Unit 18: Analysing laboratory samples using ultraviolet-visible spectrophotometer (UV-Vis)

Unit reference number: T/601/8198

QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using UV-Vis spectrophotometry analysers, in accordance with approved procedures. The learner is required to confirm that the UV-Vis analyser is ready for the analysis to be performed and that the required consumables are available. In operating the analyser, they will be expected to follow the correct procedures for calling the analyser operating program, entering operating parameters for analysis, dealing with error messages and executing the program activities safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the UV-Vis analyser, in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the UV-Vis work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying UV-Vis analyser procedures. They will have an understanding of the UV-Vis analysis process and its application, and will know about the analyser, samples and reagents used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.


174






N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

175

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng u

ltra

viole

t-vi

sible

spec

trophoto

met

er

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.3

U

se t

hre

e of th

e fo

llow

ing t

ypes

of pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.4

Confirm

that

the

equip

men

t is

cal

ibra

ted,

safe

and

read

y fo

r oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

176

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g u

ltra

viole

t-vi

sible

sp

ectr

ophoto

met

er (

UV-V

is)

oper

atio

ns:

–

confirm

that

the

inst

rum

ent

is s

et u

p a

nd r

eady

for

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

set

the

mach

ine

oper

atin

g p

rogra

m a

nd

sequen

ces

–

ensu

re t

hat

mach

ine

sett

ings

are

adju

sted

as

and w

hen

req

uired

for

the

anal

ysis

bei

ng c

arried

out

–

allo

w f

or

suitab

le s

yste

m e

quili

bra

tion,

by

runnin

g m

ethod c

onditio

ns

and m

onitoring t

he

bas

elin

e

–

ensu

re t

hat

all sp

ecim

ens

are

corr

ectly

load

ed

with r

espec

t to

the

sequen

ce r

equirem

ents

–

chec

k th

at t

he

oper

ating p

rogra

m a

nd s

equen

ce

is a

t th

e co

rrec

t st

art

poin

t, a

nd t

hat

all

the

dat

a

han

dlin

g is

read

y fo

r dat

a acq

uis

itio

n

–

oper

ate

the

anal

yser

, fo

llow

ing t

he

def

ined

oper

atin

g p

roce

dure

s, a

nd a

pply

saf

e w

ork

ing

pra

ctic

es a

nd p

roce

dure

s at

all

tim

es

1.6

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

177

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.7

Set

all

of th

e fo

llow

ing:

–

wav

elen

gth

sca

n

–

photo

met

ric

mode

–

slit w

idth

–

scan

ran

ge

–

scan

spee

d

–

dat

a in

terv

al

–

dat

a file

nam

e

1.8

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

2

Anal

yse

labora

tory

sa

mple

s usi

ng u

ltra

viole

t-vi

sible

spec

trophoto

met

er

(continued

)

2.1

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2.2

Lo

ad s

pec

imen

s fo

r anal

ysis

and r

un p

rogra

m

sequen

ces

corr

ectly

2.3

Pe

rform

all

of

the

follo

win

g t

ypes

of

scan

:

–

fixe

d w

ave

length

–

tim

e sc

an

–

wav

elen

gth

sca

n

2.4

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

178

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.5

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

2.7

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

ultra

viole

t-vi

sible

sp

ectr

ophoto

met

er

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

179

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e of la

bora

tory

sa

mple

req

uired

for

the

inve

stig

atio

ns

conduct

ed b

y th

e la

bora

tory

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

180

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

ultra

viole

t-vi

sible

sp

ectr

ophoto

met

er

(continued

)

4.1

D

escr

ibe

the

range

of sa

mple

s an

alys

ed u

sing U

V-

Vis

anal

ysis

in t

he

labora

tory

, an

d o

ther

ess

ential

re

sourc

es n

eeded

for

each

inve

stig

ation

4.2

D

escr

ibe

the

import

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy

4.3

D

escr

ibe

the

mai

n fea

ture

s of th

e U

V-V

is a

nal

yser

, an

d t

he

acce

ssories

that

can

be

use

d

4.4

D

escr

ibe

the

various

UV-V

is a

nal

yser

oper

atio

ns

that

can

be

per

form

ed,

and t

he

met

hods

and

equip

men

t use

d

4.5

D

escr

ibe

the

man

ufa

cture

r’s

inst

ruct

ions

for

chan

gin

g c

onsu

mab

les

and m

ainte

nan

ce ite

ms

in

the

UV-V

is a

nal

yser

4.6

Exp

lain

how

to inte

rpre

t th

e an

aly

ser

visu

al dis

pla

y,

and h

ow

to u

nder

stand t

he

various

mes

sages

dis

pla

yed

4.7

D

escr

ibe

the

funct

ion o

f er

ror

mes

sages

, an

d w

hat

to d

o if an

err

or

mes

sage

is d

ispla

yed

4.8

Exp

lain

how

to f

ind t

he

corr

ect

rest

art

poin

t in

the

pro

gra

m if th

e U

V-V

is h

as

bee

n s

topped

bef

ore

co

mple

tion o

f th

e pro

gra

m

4.9

Exp

lain

wher

e to

obta

in t

he

stan

dar

d o

per

ating

pro

cedure

s, e

quip

men

t pro

cedure

s an

d job

inst

ruct

ions

required

for

the

analy

sis

to b

e ca

rrie

d

out

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

181

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.1

0

Des

crib

e th

e ty

pic

al U

V-V

is f

aults,

and t

he

actions

to b

e ta

ken if th

ey o

ccur

4.1

1

Des

crib

e th

e pro

cedure

to b

e fo

llow

ed if

a bro

ken o

r le

akin

g s

am

ple

is

iden

tified

in t

he

labora

tory

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


182


183

Unit 19: Analysing laboratory samples using Circular Dichroism (CD)


QCF level: 3

Credit value: 16


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using circular dichroism (CD) spectrophotometer analysers, in accordance with approved procedures. The learner is required to confirm that the CD equipment is equilibrated and calibrated for the analysis to be performed, and that the required consumables are available. In operating the analyser, they will be expected to follow the correct procedures for calling the analyser operating program, entering operating parameters for analysis, dealing with error messages and executing the program safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

They will be required to set up and operate the CD analyser, in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, to make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

Their responsibilities will require them to comply with standard operating procedures for the CD work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

Their underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying CD analyser procedures. They will have an understanding of the CD analysis process and its application, and will know about the analyser, samples and reagents used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

They will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes. They will be required to demonstrate safe working practices throughout, and will


184

understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

185

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng C

ircu

lar

Dic

hro

ism

(CD

)

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.4

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.5

Confirm

that

the

equip

men

t is

equili

bra

ted,

calib

rate

d,

safe

and r

eady

for

oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

186

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Car

ry o

ut

all of

the

follo

win

g c

ircu

lar

dic

hro

ism

(C

D)

oper

atio

ns:

–

confirm

that

the

mach

ine

is r

eady

for

the

anal

ysis

–

chec

k th

at a

ll sa

fety

equip

men

t an

d g

uar

ds

are

in p

lace

and a

re funct

ionin

g c

orr

ectly

–

purg

e th

e eq

uip

men

t, a

nd t

urn

on t

he

lam

ps

read

y fo

r th

e an

alys

is

–

ensu

re t

hat

the

equip

men

t is

cal

ibra

ted for

the

anal

ysis

to b

e done

–

pre

par

e re

agen

ts,

sam

ple

s an

d m

achin

e oper

atin

g m

ethods

–

acquire

data

, usi

ng a

ppro

priat

e se

ttin

gs

–

anal

yse

the

dat

a, a

nd m

ake

out

a re

port

1.7

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

1.8

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

2

Anal

yse

labora

tory

sa

mple

s usi

ng C

ircu

lar

Dic

hro

ism

(CD

) (c

ontinued

)

2.1

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2.2

Lo

ad s

pec

imen

s fo

r anal

ysis

and r

un p

rogra

m

sequen

ces

corr

ectly

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

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tion L

imited

2011

187

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.3

Car

ry o

ut

all of

the

follo

win

g d

uring t

he

anal

ysis

:

–

wav

elen

gth

and inte

nsi

ty c

alib

ration

–

per

form

ance

ass

essm

ent

bas

ed o

n C

D a

nd H

T

voltage

signal

s

–

conve

rt r

aw

dat

a s

ignal

s to

abso

rban

ce a

nd

mola

r CD

, w

her

e nec

essa

ry

–

ove

rlay

spec

tra for

com

par

ison,

or

use

obje

ctiv

e sp

ectr

a co

mpar

ison t

echniq

ues

2.4

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

2.5

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

188

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

(e.

g.

labora

tory

note

book)

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

ultra

viole

t-vi

sible

sp

ectr

ophoto

met

er

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

189

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

ain f

eatu

res

of C

D a

nal

ysis

(su

ch a

s optics

, la

mp a

nd c

um

ula

tive

oper

atio

n t

ime,

nitro

gen

gas

supply

, sa

mple

com

par

tmen

t, s

ample

hold

ers

[cel

ls])

3.1

2

Exp

lain

how

to p

repare

the

equip

men

t by

purg

ing

with N

2 (

incl

udin

g s

afet

y co

nsi

der

atio

ns

in h

andlin

g

nitro

gen

gas

cyl

inder

s, s

tabili

sation o

f la

mp a

nd

elec

tronic

s)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

190

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.1

3

Exp

lain

how

to c

alib

rate

the

CD

equip

men

t fo

r w

avel

ength

and inte

nsi

ty (

e.g.

usi

ng N

d a

nd H

o

gla

ss f

ilter

s, w

her

e in

tensi

ty c

alib

ration is

conduct

ed u

sing 0

.06%

am

moniu

m d

-10-

cam

phosu

lphonat

e (A

CS)

solu

tion)

3.1

4

Des

crib

e per

form

ance

eva

luat

ion a

t a s

pec

ifie

d

wav

elen

gth

(e.

g.

0.0

6%

ACS s

olu

tion c

an b

e use

d

for

the

per

form

ance

eva

luat

ion a

t 290.4

± 0

.5 n

m

for

the

majo

rity

of C

D s

pec

tropola

rim

eter

s)

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

ultra

viole

t-vi

sible

sp

ectr

ophoto

met

er

(continued

)

4.1

D

escr

ibe

per

form

ance

eva

luat

ion u

sing t

he

HT

voltage

(e.g

. ACS s

olu

tion t

o m

onitor

deg

radat

ion

of in

stru

men

t optics

)

4.2

D

escr

ibe

the

import

ance

of an

appro

priat

e pat

h

length

sam

ple

cel

l to

ove

rcom

e pro

ble

ms

due

to

solv

ent

abso

rban

ce

4.3

Exp

lain

how

to d

eter

min

e th

e tr

ue

pat

h len

gth

of

the

sam

ple

cel

l, c

om

par

ed t

o t

he

nom

inal pat

h

length

4.4

Exp

lain

how

to p

repare

sam

ple

s (i

ncl

udin

g t

he

range

of

volu

mes

and c

once

ntr

atio

n o

f th

e sa

mple

s to

be

anal

ysed

in a

ppro

priat

e sa

mple

hold

ers

[cel

ls])

4.5

Exp

lain

how

to r

ecord

and p

repar

e sa

mple

s,

reag

ents

and b

uff

ers

(incl

udin

g intr

oduct

ion o

f buffer

or

sam

ple

to C

D c

ell w

ithout

intr

oduci

ng a

ir

bubble

s)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

191

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.6

Exp

lain

how

to m

odify

CD

dat

a ac

quis

itio

n

par

amet

ers

in o

rder

to a

cquire

a hig

h q

ualit

y CD

sp

ectr

um

(e.

g.

sensi

tivi

ty,

wav

elen

gth

ran

ge,

dat

a pitch

, sc

an m

ode,

sca

n s

pee

d,

resp

onse

, ban

dw

idth

, ac

cum

ula

tion,

data

mode)

4.7

Exp

lain

how

to a

cquire

dat

a in

a logic

al se

quen

ce

(e.g

. th

e bas

elin

e an

d e

xper

imen

tal dat

a sh

ould

be

colle

cted

usi

ng t

he

sam

e ce

ll, o

bta

inin

g a

n

abso

rban

ce s

pec

trum

for

the

sam

ple

bef

ore

m

easu

ring t

he

CD

)

4.8

Exp

lain

how

to c

lean

sam

ple

cel

ls b

etw

een

mea

sure

men

ts w

ith a

ppro

priat

e cl

eanin

g a

gen

ts

(e.g

. dei

onis

ed w

ater

, 2%

Hel

lman

ex,

ethanol,

acet

one,

dry

ing w

ith n

itro

gen

gas

)

4.9

Exp

lain

how

to c

lean

sam

ple

cel

ls w

ith s

ever

e co

nta

min

ation (

e.g.

soak

ing in n

itri

c aci

d (

70%

) ove

rnig

ht)

4.1

0

Des

crib

e th

e pre

cautionar

y sa

fety

ste

ps

when

han

dlin

g n

itric

acid

4.1

1

Exp

lain

how

to p

roce

ss d

ata a

nd a

nal

yse

it (

e.g.

conve

rtin

g H

T a

nd m

Deg

sig

nals

to a

bso

rban

ce a

nd

mola

r CD

)

4.1

2

Exp

lain

how

to a

sses

s data

qualit

y, f

or

signal

to

nois

e or

satu

ration

4.1

3

Exp

lain

how

to c

alcu

late

sec

ondar

y st

ruct

ura

l co

nte

nt

of

a pro

tein

usi

ng a

lgorith

ms

from

m

anufa

cture

rs o

r on t

he

web

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

192

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


193

Unit 20: Analysing laboratory samples using Fourier-transform infrared (FT-IR) spectroscopy


QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using Fourier-transform infrared (FT-IR) spectroscopy analysers, in accordance with approved procedures. The learner is required to confirm that the FT-IR equipment is equilibrated and calibrated for the analysis to be performed, and that the required consumables are available. In operating the analyser, they will be expected to following the correct procedures for calling the analyser operating program, entering operating parameters for analysis, dealing with error messages and executing the program activities safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and operate the FT-IR analyser in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, make the required adjustments in order to ensure that the output analysis is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the FT-IR work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying FT-IR analyser procedures. They will have an understanding of the FT-IR analysis process and its application, and will know about the analyser, samples and reagents used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.


194






N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

195

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng F

ouri

er-

tran

sform

infr

ared

(FT

-IR)

spec

trosc

opy

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.4

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

1.5

Confirm

that

the

equip

men

t is

equili

bra

ted,

calib

rate

d,

safe

and r

eady

for

oper

atio

n

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

196

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Car

ry o

ut

all of

the

follo

win

g o

per

atio

ns:

–

turn

on t

he

equip

men

t, c

ool w

ith liq

uid

nitro

gen

w

her

e nec

essa

ry,

and p

urg

e w

ith n

itro

gen

gas

–

valid

ate

the

equip

men

t

–

pre

par

e re

agen

ts,

sam

ple

s an

d m

achin

e oper

atin

g m

ethods

–

acquire

data

, usi

ng a

ppro

priat

e se

ttin

gs

–

anal

yse

the

dat

a a

nd m

ake

out

a re

port

1.7

Fo

llow

the

def

ined

pro

cedure

s fo

r st

arting a

nd

runnin

g t

he

oper

atin

g s

yste

m a

nd/o

r dat

a han

dlin

g

and c

ontr

ol so

ftw

are

1.8

Run a

ppro

pri

ate

syst

em p

ara

met

er t

ests

and

confirm

the

syst

em s

uitab

ility

for

the

anal

yses

to b

e done

2

Anal

yse

labora

tory

sa

mple

s usi

ng F

ouri

er-

tran

sform

infr

ared

(FT

-IR)

spec

trosc

opy

(continued

)

2.1

D

eal pro

mptly

and e

ffec

tive

ly w

ith e

rror

mes

sages

or

equip

men

t fa

ults

that

are

within

thei

r co

ntr

ol,

and r

eport

those

that

cannot

be

reso

lved

2.2

Lo

ad s

ample

s fo

r an

aly

sis

and r

un p

rogra

m

sequen

ces

corr

ectly

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

197

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.3

Car

ry o

ut

all of

the

follo

win

g:

–

mea

sure

sam

ple

s in

a logic

al se

quen

ce

(bac

kgro

und,

bla

nk,

sam

ple

s)

–

per

form

ance

ass

essm

ent

(e.g

. usi

ng

man

ufa

cture

r’s

reco

mm

endat

ions)

–

pro

cess

data

by

an a

ppro

priat

e m

ethod

–

ove

rlay

spec

tra for

com

par

ison,

and c

ritica

lly

asse

ss q

ualit

y of th

e dat

a

2.4

Shut

dow

n t

he

equip

men

t to

a s

afe

conditio

n o

n

concl

usi

on o

f th

e act

ivitie

s, u

sing t

he

com

pat

ible

flush

ing a

nd lin

e st

ora

ge

pro

cedure

s

2.5

Eva

luat

e dat

a in

acc

ord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d m

anufa

cture

rs’

inst

ruct

ions

2.6

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

198

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Rec

ord

det

ails

of

work

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

(e.

g.

labora

tory

note

book)

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Fourier

-tra

nsf

orm

infr

ared

(F

T-I

R)

spec

trosc

opy

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

199

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

ain f

eatu

res

of

FT-I

R a

nal

ysis

(su

ch

as s

ourc

e, s

ample

com

par

tmen

t, d

etec

tor,

liq

uid

nitro

gen

supply

, w

ater

bat

h)

3.1

2

Exp

lain

how

to e

quili

bra

te t

he

equip

men

t (e

.g.

purg

ing w

ith n

itro

gen

gas

)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

200

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Fourier

-tra

nsf

orm

infr

ared

(F

T-I

R)

spec

trosc

opy

(continued

)

4.1

Exp

lain

how

to v

alid

ate

the

inst

rum

ent

(e.g

. usi

ng

soft

war

e fr

om

the

manufa

cture

r)

4.2

Exp

lain

how

to c

reate

a logic

al s

equen

ce f

or

anal

ysis

(in

cludin

g b

ackg

round,

bla

nk

and s

am

ple

m

easu

rem

ents

, th

e ra

nge

of w

eights

, vo

lum

es a

nd

conce

ntr

atio

n o

f sa

mple

s th

at c

an b

e an

alys

ed in

appro

priat

e sa

mple

hold

ers)

4.3

Exp

lain

how

to p

repare

sam

ple

s fo

r diffe

rent

types

of an

aly

sis

mode

(tra

nsm

issi

on o

r at

tenuate

d t

ota

l re

flec

tance

[ATR])

, th

e ra

nge

of

liquid

or

solid

sa

mple

pre

par

atio

n t

echniq

ues

use

d,

and t

he

appro

priat

e so

lven

ts

4.4

Exp

lain

how

to a

ssem

ble

and d

emount

cells

re

pro

duci

bly

; th

e ch

oic

e of w

indow

mat

eria

l base

d

on s

am

ple

solu

bili

ty,

chem

ical

com

pat

ibili

ty,

and

the

range

nee

ded

4.5

Exp

lain

how

to f

ill s

am

ple

cel

ls w

ithout

intr

oduci

ng

air

bubble

s or

aggre

gat

es

4.6

Exp

lain

how

to m

odify

the

FT-I

R d

ata a

cquis

itio

n

par

amet

ers

in o

rder

to a

cquire

a hig

h q

ualit

y FT

-IR

spec

trum

(e.

g.

reso

lution,

scan

ner

vel

oci

ty,

num

ber

of

scan

s, p

has

e re

solu

tion)

4.7

Exp

lain

how

to a

cquire

sam

ple

dat

a in

a logic

al

sequen

ce,

acquirin

g a

bla

nk

spec

trum

under

the

sam

e co

nditio

ns

as

the

sam

ple

(e.

g.

tem

per

ature

, num

ber

of

scan

s, r

esolu

tion)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

201

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.8

Exp

lain

how

to c

lean

sam

ple

cel

ls o

r ATR

acce

ssories

bet

wee

n s

ample

s (e

.g.

usi

ng 2

%

Hel

lman

ex a

nd c

hec

king t

est

spec

tra for

sam

ple

ca

rryo

ver)

4.9

Exp

lain

how

to p

roce

ss a

nd a

naly

se t

he

data

(e.

g.

subtr

act

ion o

f w

ater

sig

nal

wher

e nec

essa

ry,

sele

ctio

n o

f a

spec

tral ra

nge

wher

e th

e w

ate

r abso

rbance

does

not

ove

rlap

with t

hat

of

the

solu

te

and h

as inte

nsi

ty c

om

par

able

with t

hat

in t

he

range

of in

tere

st)

4.1

0

Des

crib

e th

e m

ethods

for

pro

cess

ing d

ata

(e.

g.

by

calc

ula

ting t

he

seco

nd d

eriv

ativ

e, t

o r

emove

bro

ad

under

lyin

g c

onto

urs

in t

he

spec

tra

due

to w

ater

)

4.1

1

Exp

lain

how

to e

xtra

ct info

rmat

ion fro

m t

he

spec

tra

(e.g

. to

det

erm

ine

the

seco

ndary

str

uct

ura

l co

nte

nt

of pro

tein

), a

nd h

ow

to iden

tify

com

pounds

from

sp

ectr

al lib

raries

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


202


203

Unit 21: Analysing laboratory samples using Chromatography


QCF level: 3

Credit value: 9


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out laboratory sample analysis using chromatography, in accordance with approved procedures. The learner is required to confirm that the equipment is ready for the analysis to be performed and that the required consumables are available. In operating the equipment, they will be expected to follow the correct procedures, and to work safely and correctly. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and use the chromatography equipment in line with safe working practices and approved procedures, to monitor the analysis operations and, where necessary, to make the required adjustments in order to ensure that the output is to the required quality and accuracy. Meeting laboratory targets will be an important issue, and their laboratory records must show consistent and satisfactory performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the chromatography work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying chromatography analysis procedures. They will have an understanding of the chromatography analysis process and its application, and will know about the equipment, samples and reagents used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.



204





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

205

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

labora

tory

sa

mple

s usi

ng

Chro

mat

ogra

phy

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

when

han

dlin

g s

pec

imen

s

1.4

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

206

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.5

Car

ry o

ut

all of

the

follo

win

g:

–

use

the

corr

ect

issu

e of

job inst

ruct

ions

and

spec

ific

atio

ns

–

follo

w r

isk

asse

ssm

ent

pro

cedure

s an

d C

OSH

H

regula

tions

–

pre

par

e m

edia

for

size

of co

lum

n,

and w

ash

it

–

asse

mble

and c

hec

k th

e co

lum

n c

om

ponen

ts

–

pour

chro

mat

ogra

phy

mate

rial in

to t

he

colu

mn,

seal

the

colu

mn a

nd s

et t

he

plu

nger

–

conduct

a p

acki

ng t

est,

set

the

pre

ssure

lim

it

and flo

w r

ate

of th

e buffer

solu

tion

–

connec

t pip

ework

to t

he

colu

mn,

and p

repar

e fo

r th

e lo

adin

g a

nd c

olle

ctio

n o

f fr

act

ions

–

run t

he

pro

gra

m for

load

ing,

and m

onitor

the

syst

em inst

rum

ents

–

store

fra

ctio

ns

in s

teri

le c

onta

iner

s, a

nd s

end

sam

ple

s fo

r an

alys

is

–

stop t

he

pro

cess

ing,

clea

n in p

lace

and d

ispose

of w

ast

e

–

store

conta

iner

s w

ith fra

ctio

ns

in t

he

corr

ect

loca

tion a

nd q

uan

tities

for

furt

her

pro

cess

ing

–

store

rec

ord

s of

your

activi

ties

, in

acc

ord

ance

w

ith a

ppro

priat

e pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

207

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.6

Lo

ad t

he

colu

mn b

y both

of

the

follo

win

g m

ethods:

–

man

ual

loadin

g

–

auto

mat

ed load

ing

1.7

Fi

ll th

e co

lum

n w

ith b

oth

of

the

follo

win

g f

ilter

ty

pes

:

–

uniform

mat

rix

–

den

sity

gra

die

nt

1.8

Conduct

a p

acki

ng t

est,

to incl

ude

all of th

e fo

llow

ing:

–

inje

ct

–

asym

met

ry

–

hei

ght

equiv

alen

t to

a t

heo

retica

l pla

te (

HETP)

1.9

Pr

epare

the

filter

unit a

nd c

onnec

t to

the

bio

mat

eria

l so

urc

e fo

r pro

cess

ing,

in a

ccord

ance

w

ith e

stab

lished

pra

ctic

es a

nd p

roce

dure

s

1.1

0

Set

the

syst

em p

ress

ure

lim

it f

or

all of th

e fo

llow

ing:

–

med

ia t

ype

–

colu

mn t

ype

–

syst

em t

ype

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

208

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Anal

yse

labora

tory

sa

mple

s usi

ng

Chro

mat

ogra

phy

(continued

)

2.1

Pu

mp b

iom

ater

ial th

rough t

he

filter

unit,

monitoring

and a

dju

stin

g flo

w-r

ate

acc

ord

ing t

o s

pec

ific

atio

n

2.2

M

onitor

all

of th

e fo

llow

ing s

yste

m p

ara

met

ers:

–

pre

ssure

–

flow

-rat

e

–

frac

tion

–

colle

ctio

n

–

pH

–

uV

–

conduct

ivity

–

tem

per

ature

2.3

Colle

ct t

he

filter

ed b

iom

ater

ial in

the

corr

ect

ase

ptic

conta

iner

s an

d q

uan

tities

2.4

Colle

ct f

ract

ions

in a

ll of th

e fo

llow

ing:

–

ster

ile b

ags

–

ster

ile c

onta

iner

s

–

ster

ile t

ubes

2.5

Pe

rform

a f

ilter

unit inte

grity

tes

t, in a

ccord

ance

w

ith e

stab

lished

pra

ctic

es a

nd p

roce

dure

s

2.6

D

ispose

of

was

te in t

he

corr

ect

man

ner

and

loca

tion,

and t

idy

and c

lean

the

work

are

a,

in

acco

rdan

ce w

ith e

stablis

hed

pro

cedure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

209

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.7

Sep

arat

e outp

uts

into

all

of th

e fo

llow

ing

cate

gories

:

–

was

te for

auto

clav

ing

–

was

te for

chem

ical cl

eanin

g

–

was

te for

flush

ing

–

bio

mat

eria

l pro

duct

2.8

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

with

dep

artm

enta

l an

d o

rgan

isat

ional

pro

cedure

s

2.9

Rec

ord

det

ails

of

work

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

210

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Chro

mat

ogra

phy

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

are

a in

whic

h y

ou a

re c

arry

ing o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

while

under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

211

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t an

d t

he

links

w

ith t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

4

Know

how

to a

nal

yse

labora

tory

sam

ple

s usi

ng

Chro

mat

ogra

phy

(continued

)

4.1

D

escr

ibe

the

basi

c princi

ple

of

purifica

tion u

sing

larg

e-sc

ale

chro

mat

ogra

phy

4.2

D

escr

ibe

the

pro

cedure

s fo

r lo

adin

g,

pack

ing a

nd

sett

ing p

lunger

s fo

r optim

al h

eight

in lar

ge-

scal

e ch

rom

ato

gra

phy

4.3

Exp

lain

how

to c

onduct

pac

king t

ests

(su

ch a

s in

ject

, as

ymm

etry

and H

ETP)

4.4

Exp

lain

how

to s

et p

ress

ure

lim

its

and f

low

rat

es o

f buffer

solu

tion

4.5

Exp

lain

how

to c

onnec

t pip

ework

to t

he

syst

em for

pro

cess

ing

4.6

Exp

lain

how

to m

onitor

the

syst

em inst

rum

enta

tion

4.7

Exp

lain

how

to s

tore

fra

ctio

ns

and c

olle

ct s

ample

s

4.8

Exp

lain

how

to s

tore

, se

para

te a

nd d

ispose

of w

aste

in

the

corr

ect

man

ner

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

212

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.9

D

escr

ibe

the

mai

n d

iffe

rence

s bet

wee

n u

niform

and

den

sity

gra

die

nt

colu

mn m

ater

ials

4.1

0

Exp

lain

how

to s

tore

fill

ed b

iom

ater

ial co

nta

iner

s fo

r fu

rther

pro

cess

ing

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


213

Unit 22: Using and communicating laboratory information to authorised personnel

Unit reference number: T/601/8203

QCF level: 3

Credit value: 6


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to use and communicate laboratory information to authorised personnel, in accordance with approved procedures. The learner will be able to access data from the laboratory information management system (LIMS), from the appropriate files, as well as other laboratory paperwork, and they will need to communicate accurately the information to authorised personnel. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will also be required to present records and details of their laboratory work to the appropriate people.

The learner’s responsibilities will require them to access laboratory data on tests/samples, and to provide this to authorised personnel, in accordance with organisational procedures. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide an understanding of the data requirements for tests/samples and test requirements for the speciality that they work in. They will understand the importance of the Data Protection Act, and the need to maintain the security and integrity of the laboratory records.

The learner’s underpinning knowledge will provide a good understanding of their work, and will provide an informed approach to accessing laboratory information and communicating this to authorised personnel, in a laboratory environment. They will understand the need to work efficiently and effectively, and will know what to consider when communicating laboratory information, including how to deal with problems, and how to achieve their work objectives and targets, in adequate depth to provide a sound basis for carrying out the activities safely and correctly.

The learner will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes. They will be required to demonstrate safe working practices throughout, and will


214

understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

215

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Use

and c

om

munic

ate

labora

tory

info

rmat

ion t

o

auth

orise

d p

erso

nnel

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

Ensu

re t

he

inte

grity

of th

e la

bora

tory

info

rmat

ion

man

agem

ent

syst

em (

LIM

S)

by

all of th

e fo

llow

ing:

–

usi

ng t

he

corr

ect

star

tup/s

hutd

ow

n p

roce

dure

s

–

follo

win

g g

ood p

ract

ice

for

loggin

g o

n/o

ff

–

info

rmat

ion is

pass

ed t

o a

uth

orise

d p

eople

only

1.4

Sea

rch a

nd a

cces

s dat

a fr

om

the

LIM

S f

or

thre

e of

the

follo

win

g:

–

test

/sam

ple

info

rmation

–

pro

cess

info

rmat

ion

–

outp

ut

qualit

y in

form

atio

n

–

cost

/budget

info

rmation

–

work

del

iver

y in

form

atio

n

–

oth

er (

ple

ase

spec

ify)

1.5

Fo

llow

pro

cedure

s co

rrec

tly

to e

nsu

re t

he

secu

rity

an

d c

onfiden

tial

ity

of la

bora

tory

info

rmat

ion

1.6

Rec

eive

and r

ecord

the

info

rmation fro

m c

ust

om

ers,

in

the

appro

priat

e m

anner

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

216

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2

Use

and c

om

munic

ate

labora

tory

info

rmat

ion t

o

auth

orise

d p

erso

nnel

(c

ontinued

)

2.1

Fo

rwar

d m

essa

ges

and info

rmation t

o t

he

appro

priat

e peo

ple

, in

acc

ord

ance

with p

roce

dure

s

2.2

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

2.3

Com

munic

ate

labora

tory

info

rmat

ion t

o t

hre

e of

the

follo

win

g c

ust

om

ers:

–

oth

er d

epart

men

t

–

clin

icia

n/s

cien

tist

–

team

mem

ber

s

–

oth

er lab

ora

tories

–

oth

er (

ple

ase

spec

ify)

2.4

Com

munic

ate

four

of th

e fo

llow

ing t

ypes

of

info

rmat

ion:

–

inst

ruct

ions

–

test

res

ults

–

pro

gre

ss r

eport

–

work

req

uirem

ents

–

serv

ices

ava

ilable

–

oth

er (

ple

ase

spec

ify)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

217

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.5

Rec

ord

det

ails

of

work

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to u

se a

nd

com

munic

ate

labora

tory

in

form

atio

n t

o a

uth

orise

d

per

sonnel

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

stan

dar

d o

per

atin

g p

roce

dure

s, a

s se

t dow

n in t

he

loca

l la

bora

tory

oper

atin

g m

anual

s

3.5

D

escr

ibe

the

dat

a s

ecurity

req

uirem

ents

for

diffe

rent

com

pute

r applic

atio

ns

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

218

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.6

Exp

lain

how

to a

cces

s an

d s

tore

dat

a, in

acco

rdan

ce w

ith s

tandar

d o

per

ating p

roce

dure

s an

d

org

anis

atio

nal

pra

ctic

es

3.7

Exp

lain

why

it is

import

ant

to m

ainta

in a

ccura

te

test

/sam

ple

and d

epar

tmen

tal re

cord

s

3.8

D

escr

ibe

the

spec

ific

safe

ty p

reca

utions

to b

e ta

ken

when

work

ing w

ith c

om

pute

r sy

stem

s (t

o incl

ude

such

thin

gs

as

safe

ty g

uid

ance

rel

atin

g t

o t

he

use

of

visu

al d

ispla

y unit (

VD

U)

equip

men

t an

d

work

stat

ion e

nvi

ronm

ent

(such

as

lighting,

seat

ing,

posi

tionin

g o

f eq

uip

men

t),

repet

itiv

e st

rain

inju

ry

(RSI)

; th

e dan

ger

s of

trai

ling lea

ds

and c

able

s; h

ow

to

spot

faulty

or

dan

ger

ous

elec

tric

al lea

ds,

plu

gs

and c

onnec

tions)

3.9

Exp

lain

why

it is

import

ant

to m

ainta

in g

ood

house

keep

ing a

rran

gem

ents

(su

ch a

s putt

ing d

isks

, m

anual

s and u

nw

ante

d ite

ms

of eq

uip

men

t in

to

safe

sto

rage;

lea

ving t

he

work

are

a in a

saf

e an

d

tidy

conditio

n)

3.1

0

Des

crib

e th

e la

bora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.1

1

Des

crib

e th

e ty

pes

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

am

ple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.1

2

Des

crib

e th

e im

port

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r te

sts/

sam

ple

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

219

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.1

3

Des

crib

e th

e org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

4

Know

how

to u

se a

nd

com

munic

ate

labora

tory

in

form

atio

n t

o a

uth

orise

d

per

sonnel

(co

ntinued

)

4.1

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

4.2

D

escr

ibe

the

limits

of th

eir

ow

n a

uth

ority

and t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

4.3

D

escr

ibe

the

basi

c se

t-up a

nd o

per

atio

n o

f th

e la

bora

tory

rec

ord

s sy

stem

and t

he

per

ipher

al

dev

ices

that

are

use

d (

such

as

mouse

, ke

yboar

d,

VD

U,

pri

nte

r and b

arco

de

reader

)

4.4

D

escr

ibe

the

corr

ect

star

tup a

nd s

hutd

ow

n

pro

cedure

s to

be

use

d for

the

com

pute

r sy

stem

4.5

Exp

lain

how

to a

cces

s th

e sp

ecific

com

pute

r la

bora

tory

info

rmat

ion m

anag

emen

t sy

stem

(LI

MS)

dat

abase

to b

e use

d,

and t

he

use

of

soft

war

e m

anual

s and r

elat

ed d

ocu

men

ts t

o a

id e

ffic

ient

oper

atio

n o

f th

e re

leva

nt

labora

tory

rec

ord

s sy

stem

4.6

Exp

lain

how

to d

eal w

ith s

yste

m p

roble

ms

(such

as

erro

r m

essa

ges

rec

eive

d,

per

ipher

als

whic

h d

o n

ot

resp

ond a

s ex

pec

ted,

obvi

ous

faults

with t

he

equip

men

t or

connec

ting lea

ds)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

220

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.7

Exp

lain

how

to a

cces

s an

d c

om

munic

ate

dat

a ef

fect

ivel

y, a

nd h

ow

to iden

tify

key

info

rmat

ion

when

rec

ord

ing a

nd f

orw

ardin

g m

essa

ges

ac

cura

tely

4.8

Exp

lain

wher

e to

obta

in t

he

info

rmat

ion t

hat

they

nee

d t

o c

arr

y out

thei

r jo

b,

the

form

in w

hic

h t

he

info

rmat

ion is

expre

ssed

and w

hy

it s

hould

be

up t

o

dat

e

4.9

D

escr

ibe

the

diffe

rent

form

s of

com

munic

atio

n

avai

lable

to t

hem

, an

d h

ow

they

are

use

d

4.1

0

Exp

lain

why

it is

import

ant

to c

om

munic

ate

cle

arly

an

d t

o g

ive

all of th

e in

form

atio

n n

eces

sary

to t

he

audie

nce

4.1

1

Des

crib

e th

e org

anis

atio

nal

and/o

r la

bora

tory

pro

cedure

s fo

r ac

know

ledgin

g a

nd r

espondin

g t

o

inco

min

g a

nd o

utg

oin

g info

rmation

4.1

2

Des

crib

e th

e org

anis

atio

nal

and/o

r la

bora

tory

pro

cedure

s fo

r re

cord

ing lab

ora

tory

info

rmat

ion

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


221

Unit 23: Analysing DNA using gel electrophoresis

Unit reference number: F/601/8205

QCF level: 3

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to carry out DNA sample analysis by gel electrophoresis, in accordance with approved procedures. The learner is required to confirm that the necessary reagents are available and have been stored in the way indicated by the supplier. They will be expected to follow the correct procedures, and to ensure that a high standard of cleanliness is maintained with due regard for the risk of cross contamination of samples. The learner will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be expected to handle potentially dangerous chemicals, ensuring that they are contained within designated areas whilst in use and are disposed of in the correct way. They will be required to present records and details of their laboratory work to the appropriate people.

The learner will be required to set up and run agarose gels by gel electrophoresis, to interpret the DNA data and, where necessary, to repeat the analysis to confirm or clarify the result. Conforming to the laboratory quality system will be an important aspect of their work and their laboratory records must reflect consistent experimental and data recording and reporting performance.

The learner’s responsibilities will require them to comply with standard operating procedures for the gel electrophoresis work activities undertaken, and to report any problems that they cannot personally resolve, or that are outside their permitted authority, to the relevant people. They will be expected to work to instructions with a minimum of supervision, either on their own or as part of a team, taking personal responsibility for their own actions and for the quality and accuracy of the work that they carry out.

The learner’s underpinning knowledge will be sufficient to provide a sound basis for their work, and will enable them to adopt an informed approach to applying DNA analysis procedures. They will have an understanding of the gel electrophoresis process and its application, and will know about the analysis, samples and reagents used, in adequate depth to provide a sound background for carrying out the laboratory activities to the required specification.

The learner will understand the safety precautions required when carrying out the laboratory activities for scientific operations and processes, and the


222

potential environmental impacts. They will be required to demonstrate safe working practices throughout, and will understand their responsibility for taking the necessary safeguards to protect themselves and others in the workplace.





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

223

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Anal

yse

DN

A u

sing g

el

elec

trophore

sis

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ear

the

appro

priat

e per

sonal

pro

tect

ion

equip

men

t (P

PE)

or

hav

e th

e ap

pro

priat

e sa

fety

co

ntr

ols

in p

lace

when

han

dlin

g s

pec

imen

s

1.3

W

ear

thre

e of

the

follo

win

g t

ypes

of

pro

tect

ive

cloth

ing a

nd e

quip

men

t:

–

labora

tory

coat

/ove

ralls

–

face

mask

/res

pir

ator

–

glo

ves

–

safe

ty g

lass

es/s

afe

ty g

oggle

s

–

mop c

ap

–

oth

er (

ple

ase

spec

ify)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

224

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.4

Car

ry o

ut

all of

the

follo

win

g o

per

atio

ns:

–

pre

par

e ag

arose

gel

s fo

r an

alys

is

–

load

DN

A s

ample

s onto

an a

gar

ose

gel

for

elec

trophore

sis,

and s

et t

he

pow

er s

upply

at

an

appro

priat

e le

vel

–

visu

alis

e and r

ecord

dat

a (s

uch

as

via d

igital

ca

mer

a),

in a

ccord

ance

with d

epar

tmen

tal

pro

cedure

s

–

dis

pose

of

agar

ose

gel

s sa

fely

, in

acc

ord

ance

w

ith d

epar

tmen

tal oper

atin

g p

roce

dure

s an

d

loca

l re

quirem

ents

1.5

Pr

epare

the

appro

priat

e per

centa

ge

agar

ose

gel

for

the

amplif

ied D

NA fra

gm

ent.

1.6

Ensu

re t

hat

inte

rcala

ting d

yes

(EtB

R,

SYBR g

reen

, et

c) a

re a

dded

to t

he

gel

during s

etup,

acc

ord

ing t

o

stan

dar

d o

per

atin

g p

roce

dure

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

225

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1.7

Car

ry o

ut

all fo

llow

ing g

el e

lect

rophore

sis

act

ivitie

s:

–

rem

ove

gel

com

b

–

subm

erge

in r

unnin

g b

uff

er

–

load

the

ladder

(s)

–

pre

par

e th

e sa

mple

and load t

he

dye

–

load

sam

ple

s onto

gel

–

connec

t to

gel

box

and o

per

ate

pow

er s

upply

–

dis

pose

of

unw

ante

d g

el in h

azard

ous

was

te

2

Anal

yse

DN

A u

sing g

el

elec

trophore

sis

(continued

)

2.1

Lo

ad t

he

DN

A r

efer

ence

lad

der

s an

d s

am

ple

s w

ith

the

appro

priat

e D

NA v

isualis

atio

n d

ye,

and r

un g

els

acc

ord

ing t

o s

tandar

d o

per

ating p

roce

dure

s

2.2

Pe

rform

gel

ele

ctro

phore

sis

anal

ysis

for

one

of th

e fo

llow

ing c

ateg

ories

:

–

larg

e D

NA f

ragm

ents

(5–10kb

)

–

smal

l D

NA f

ragm

ents

(0.2

–1kb

)

2.3

Vis

ualis

e th

e gel

usi

ng U

V o

r w

hite

light,

as

appro

priat

e, a

nd a

ccord

ing t

o s

tandar

d o

per

atin

g

pro

cedure

s

2.4

D

ispose

of

spen

t m

ater

ials

(gel

and b

uff

er s

yste

ms)

ap

pro

priat

ely

and a

ccord

ing t

o loca

l re

quirem

ents

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

226

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.6

Eva

luat

e th

e dat

a, in a

ccord

ance

with s

tandar

d

oper

atin

g p

roce

dure

s an

d lab

ora

tory

inst

ruct

ions

2.7

Com

munic

ate

the

required

info

rmat

ion a

bout

the

work

done,

to a

uth

orise

d p

eople

, in

acc

ord

ance

w

ith d

epar

tmen

tal an

d o

rganis

ational

pro

cedure

s

2.8

Rec

ord

det

ails

of

the

work

, an

d c

om

munic

ate

the

det

ails

to t

he

appro

priat

e peo

ple

, usi

ng:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

3

Know

how

to a

nal

yse

DN

A

usi

ng g

el e

lect

rophore

sis

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

227

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.3

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.4

D

escr

ibe

the

import

ance

of w

earing p

rote

ctiv

e cl

oth

ing,

glo

ves

and e

ye p

rote

ctio

n w

hen

handlin

g

labora

tory

sam

ple

s fo

r an

alys

is

3.5

D

escr

ibe

the

labora

tory

sam

ple

rec

eption,

reco

rds

dat

abase

and t

rack

ing s

yste

m

3.6

D

escr

ibe

the

types

of han

dlin

g a

nd s

ort

ing s

yste

m

use

d,

and t

he

pro

cedure

s an

d p

ract

ices

use

d for

tran

sfer

ring s

pec

imen

s/sa

mple

s w

ithin

the

labora

tory

whils

t under

goin

g p

roce

ssin

g

3.7

D

escr

ibe

the

import

ance

of usi

ng t

he

corr

ect

iden

tifica

tion,

and a

ny

uniq

ue

org

anis

ational

or

labora

tory

num

ber

s fo

r sp

ecim

ens/

sam

ple

s

3.8

D

escr

ibe

the

org

anis

atio

nal

req

uirem

ents

for

mai

nta

inin

g t

he

secu

rity

of th

e w

ork

pla

ce (

e.g.

work

pla

ce a

cces

s an

d lab

ora

tory

sam

ple

co

nta

inm

ent)

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

he

links

w

ith t

he

rest

of

the

org

anis

ation

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

228

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

3.1

1

Des

crib

e th

e m

inim

um

siz

e/vo

lum

e/D

NA

conce

ntr

atio

n o

f la

bora

tory

sam

ple

req

uir

ed

3.1

2

Des

crib

e th

e ra

nge

of sa

mple

s an

alys

ed,

the

conta

iner

s use

d f

or

sam

ple

sto

rage

in t

he

labora

tory

, an

d o

ther

ess

ential

res

ourc

es n

eeded

fo

r ea

ch inve

stig

atio

n

3.1

3

Des

crib

e th

e im

port

ance

of

keep

ing t

he

work

are

a

clea

n a

nd t

idy,

and o

f av

oid

ing c

ross

conta

min

atio

n

of

sam

ple

s

3.1

4

Des

crib

e th

e m

ain t

ypes

of gel

solu

tion u

sed for

anal

ysis

(su

ch a

s gel

per

centa

ge

(bet

wee

n 0

.2 a

nd

2%

) fo

r la

rge

and s

mal

l D

NA f

ragm

ents

)

4

Know

how

to a

nal

yse

DN

A

usi

ng g

el e

lect

rophore

sis

(continued

)

4.1

D

escr

ibe

the

diffe

rent

types

of

gel

tan

k use

d (

such

as

8x1

0cm

gel

(m

inig

els)

)

4.2

D

escr

ibe

the

typic

al D

NA s

ample

siz

e to

be

loaded

fo

r a

ladder

to b

e vi

sible

under

UV lig

ht

4.3

D

escr

ibe

the

range

of gel

com

bs

ava

ilable

, an

d t

he

mai

n f

acto

rs t

o c

onsi

der

when

sel

ecting o

ne

for

use

(s

uch

as

DN

A s

ample

siz

e, n

um

ber

of

teet

h)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

229

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.4

Exp

lain

how

to t

ransf

er a

n a

ppro

priat

e am

ount

of

each

sam

ple

to a

fre

sh m

icro

fuge

tube

4.5

Exp

lain

how

to a

dd a

n a

ppro

priat

e am

ount

of

loadin

g b

uffer

and D

NA s

am

ple

onto

the

gel

4.6

Exp

lain

how

to load

the

gel

tra

y w

ith m

arke

r bef

ore

an

d a

fter

load

ing t

he

sam

ple

s

4.7

Exp

lain

how

to c

lose

the

gel

tan

k, s

witch

on t

he

pow

er s

ourc

e an

d r

un t

he

gel

at

the

corr

ect

voltag

e an

d t

ime

4.8

D

escr

ibe

the

poin

t at

whic

h t

o s

witch

off

the

pow

er

supply

(su

ch a

s w

hen

the

dye

is

2/ 3

to

¾ o

f th

e w

ay d

ow

n t

he

gel

)

4.9

Exp

lain

how

to u

se a

sta

in b

ox

to s

tain

the

gel

la

dder

4.1

0

Exp

lain

how

to v

iew

and r

ecord

dat

a fro

m t

he

gel

la

dder

(su

ch a

s U

V lig

ht

and a

dig

ital ca

mer

a)

4.1

1

Exp

lain

how

DN

A s

am

ple

s ca

n b

e ex

cise

d fro

m g

els

when

iso

lation is

required

4.1

2

Exp

lain

how

to c

onst

ruct

and u

se a

calib

ration

curv

e fo

r m

arke

rs

4.1

3

Exp

lain

how

to r

ecord

and inte

rpre

t re

sults

from

gel

el

ectr

ophore

sis

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

230

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


231

Unit 24: Using statistical process control (SPC) for laboratory measurement processes


QCF level: 4

Credit value: 8


Unit summary

This unit covers the skills and knowledge needed to prove the competences required to analyse laboratory data, and to apply the principles and processes of statistical process control (SPC), in accordance with approved procedures and practices. The learner will be expected to apply SPC, utilising statistical and graphical methods to represent the laboratory data. Typically, these would include run charts, tally charts, bar charts, histograms, box plots, Pareto diagrams, stem and leaf plots, and summary statistics. The competences include seeking authority and terms of reference from a senior scientist/project leader for the work to be undertaken. They will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP). They will be required to present their analysis of the data to the appropriate people.

The learner’s responsibilities will require them to comply with organisational policy and procedures for analysing laboratory measurement processes, and to report any problems that they cannot personally resolve to the relevant authority. They will be expected to work unsupervised, either on their own or as part of a team, which they may lead or direct, taking full responsibility for their actions and, possibly, for the work of colleagues or subordinates.

The learner’s underpinning knowledge will provide a good understanding of general and discipline-specific drug development principles and processes. They will understand the physical drug form principles and different modes of administration, data analysis methods, and patent, copyright and intellectual property issues, project planning and methodology for analysing laboratory measurements. They will be able to apply SPC with sufficient depth of understanding to enable them to show results to the required standard.

The learner will be fully aware of any health, safety and environmental requirements, and the appropriate legislative and regulatory frameworks, applicable to their area of responsibility. They will be required to ensure that safe working practices are maintained throughout, and will understand the responsibility they owe to themselves and others in the workplace.


232





N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

233

Lear

nin

g ou

tcom

es a

nd a

sses

smen

t cr

iter

ia

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

1

Use

sta

tist

ical

pro

cess

co

ntr

ol fo

r la

bora

tory

m

easu

rem

ent

pro

cess

es

1.1

Ensu

re t

hat

thei

r w

ork

is

carr

ied o

ut

in a

ccord

ance

w

ith s

tandar

d o

per

atin

g p

roce

dure

s

1.2

W

ork

safe

ly a

t al

l tim

es,

com

ply

ing w

ith h

ealth a

nd

safe

ty a

nd o

ther

rel

evan

t re

gula

tions

and g

uid

elin

es

1.3

Id

entify

the

appro

priat

e an

aly

tica

l pro

cess

to b

e st

udie

d u

sing S

PC

1.4

Est

ablis

h t

he

scope

and p

urp

ose

of th

e la

bora

tory

dat

a to

be

anal

ysed

1.5

Consu

lt w

ith r

elev

ant

peo

ple

, and g

ather

all

the

nec

essa

ry d

ata

for

anal

ysis

1.6

Apply

the

princi

ple

s an

d p

roce

sses

of st

atis

tica

l pro

cess

contr

ol to

the

labora

tory

mea

sure

men

t pro

cess

2

Use

sta

tist

ical

pro

cess

co

ntr

ol fo

r la

bora

tory

m

easu

rem

ent

pro

cess

es

(continued

)

2.1

Com

ple

te a

ll of

the

follo

win

g f

or

anal

ytic

al

pro

cess

es:

–

pla

n t

he

anal

ysis

of la

bora

tory

mea

sure

men

t pro

cess

es in a

logic

al a

nd s

truct

ure

d w

ay

–

asse

ss t

he

pre

cisi

on o

f a m

easu

rem

ent

syst

em

–

det

erm

ine

if t

he

syst

em is

stab

le w

ith r

espec

t to

a

num

ber

of

variable

s

–

quan

tify

the

amount

of

variation t

hat

exi

sts

within

a p

art

icula

r sa

mple

–

quan

tify

the

amount

of

variat

ion fro

m s

am

ple

to

sam

ple

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

234

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

2.2

U

tilis

e st

atist

ical

and g

raphic

al m

ethods

to p

rese

nt

the

resu

lts

of th

e an

aly

sis

2.3

Pr

oduce

gra

phic

al an

alys

is in t

hre

e of

the

follo

win

g

form

ats

:

–

run c

har

ts

–

tally

char

ts

–

bar

char

ts

–

his

togra

ms

–

box

plo

ts

–

Pare

to d

iagra

ms

–

stem

and lea

f plo

ts

–

multi-

vari

char

ts

2.4

Pr

esen

t th

e re

sults

of an

alys

is t

o t

he

appro

priat

e peo

ple

2.5

Rec

ord

det

ails

of th

e w

ork

done,

and c

om

munic

ate

the

det

ails

to t

he

appro

priate

peo

ple

, usi

ng b

oth

:

–

verb

al re

port

Plus

one

met

hod f

rom

the

follo

win

g:

–

writt

en o

r ty

ped

rep

ort

(e.

g.

labora

tory

note

book)

–

spec

ific

com

pan

y docu

men

tation

–

com

pute

r-bas

ed r

ecord

–

elec

tronic

mai

l

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

235

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3

Know

how

to u

se

stat

istica

l pro

cess

contr

ol

for

labora

tory

m

easu

rem

ent

pro

cess

es

3.1

D

escr

ibe

the

hea

lth a

nd s

afe

ty r

equirem

ents

of

the

area

in w

hic

h t

hey

are

carr

ying o

ut

the

labora

tory

ac

tivi

ties

3.2

D

escr

ibe

the

implic

atio

ns

of not

taki

ng a

ccount

of

legis

lation,

regula

tions,

sta

ndar

ds

and g

uid

elin

es

when

conduct

ing lab

ora

tory

act

ivitie

s

3.3

D

escr

ibe

the

stan

dar

d o

per

atin

g p

roce

dure

s, a

s se

t dow

n in loca

l la

bora

tory

oper

ating m

anuals

3.4

D

escr

ibe

the

princi

ple

s of G

ood L

abora

tory

Pra

ctic

e (G

LP)

and/o

r G

ood C

linic

al Pr

actice

(G

CP)

/Good

Man

ufa

cturing P

ract

ice

(GM

P) a

pplie

d in t

he

work

pla

ce

3.5

D

escr

ibe

the

purp

ose

or

spec

ialit

y of th

e dep

artm

ent

in w

hic

h t

hey

are

em

plo

yed,

and h

ow

it

fits

into

the

oth

er s

pec

ialit

ies

of th

e la

rger

org

anis

atio

n

3.6

D

escr

ibe

the

inte

ract

ions

whic

h t

ake

pla

ce b

etw

een

the

dep

artm

ent

and o

ther

spec

ialit

ies

in t

he

sam

e org

anis

atio

n

3.7

D

escr

ibe

the

inte

ract

ions

whic

h t

ake

pla

ce b

etw

een

the

spec

ialit

y in

whic

h t

hey

are

em

plo

yed a

nd

oth

ers

in t

he

sam

e sp

ecia

lity

outs

ide

the

org

anis

atio

n

3.8

Exp

lain

how

thei

r w

ork

act

ivitie

s affec

t oth

ers

within

the

dep

artm

ent,

org

anis

ation a

nd t

he

com

munity

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

236

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

3.9

D

escr

ibe

the

lines

of

com

munic

atio

n a

nd

resp

onsi

bili

ties

in t

hei

r dep

art

men

t, a

nd t

hei

r lin

ks

with t

he

rest

of

the

org

anis

ation

3.1

0

Des

crib

e th

e lim

its

of th

eir

ow

n a

uth

ori

ty a

nd t

o

whom

they

should

rep

ort

if th

ey h

ave

pro

ble

ms

that

they

can

not

reso

lve

4

Know

how

to u

se

stat

istica

l pro

cess

contr

ol

for

labora

tory

m

easu

rem

ent

pro

cess

es

(continued

)

4.1

D

escr

ibe

the

org

anis

atio

n’s

req

uirem

ents

for

reco

rdin

g a

nd a

rchiv

ing r

eport

s

4.2

Exp

lain

how

to a

pply

sta

tist

ical

pro

cess

contr

ol

char

ts t

o m

easu

rem

ent

pro

cess

es

4.3

Exp

lain

why

acc

ura

cy a

nd p

reci

sion in

mea

sure

men

t an

alys

is is

esse

ntial to

ensu

re

appro

priat

e co

ncl

usi

ons

in e

xper

imen

tal re

sults

4.4

D

escr

ibe

the

way

s to

def

ine

limits

(such

as

limits

of

det

ection,

det

erm

inat

ion,

quan

tita

tion a

nd

quan

tifica

tion)

4.5

Exp

lain

how

to u

se o

utlie

r te

sts

and lim

its

of

det

ection c

orr

ectly,

and w

hen

not

to u

se t

hem

4.6

Exp

lain

how

to r

ecognis

e th

e ac

tion s

ignal on t

he

contr

ol ch

art

4.7

Exp

lain

how

to s

et in-h

ouse

spec

ific

atio

ns

4.8

Exp

lain

how

to u

nder

stan

d t

he

influen

ce o

f sa

mple

si

ze (

e.g.

in c

ontr

ol ch

arts

for

gro

uped

dat

a, o

n

stat

istica

l si

gnific

ance

and p

ow

er)

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

237

Learn

ing

ou

tco

mes

Ass

ess

men

t cr

iteri

a

Evid

en

ce

typ

e

Po

rtfo

lio

re

fere

nce

D

ate

4.9

Exp

lain

how

to u

nder

stan

d t

he

stre

ngth

s an

d

wea

knes

ses

of data

(e.

g.

the

import

ance

of usi

ng

the

stan

dard

oper

atin

g p

roce

dure

)

4.1

0

Exp

lain

how

to u

se s

tatist

ical te

chniq

ues

to a

sses

s ex

per

imen

tal ap

pro

ach

es w

ith r

espec

t to

spec

ific

ity,

se

nsi

tivi

ty a

nd lin

eari

ty

Lear

ner

nam

e:__________________________________________

D

ate:

___________________________

Lear

ner

sig

nat

ure

:_______________________________________

D

ate:

___________________________

Ass

esso

r si

gnat

ure

:______________________________________

D

ate:

___________________________

Inte

rnal

ver

ifie

r si

gnatu

re:

________________________________

(i

f sa

mple

d)

Dat

e:___________________________


238


239

Further information

Our customer service numbers are:

BTEC and NVQ 0844 576 0026

GCSE 0844 576 0027

GCE 0844 576 0025

The Diploma 0844 576 0028

DiDA and other qualifications 0844 576 0031

Calls may be recorded for training purposes.

Useful publications

Related information and publications include:

Centre Handbook for Edexcel QCF NVQs and Competence-based Qualifications published annually

functional skills publications – specifications, tutor support materials and question papers

Regulatory Arrangements for the Qualification and Credit Framework (published by Ofqual, August 2008)

the current Edexcel publications catalogue and update catalogue.

Edexcel publications concerning the Quality Assurance System and the internal and standards verification of vocationally related programmes can be found on the Edexcel website.

NB: Some of our publications are priced. There is also a charge for postage and packing. Please check the cost when you order.

How to obtain National Occupational Standards

To obtain the National Occupational Standards for Laboratory Science please go to:

SEMTA www.semta.org.uk


240

Professional development and training

Edexcel supports UK and international customers with training related to NVQ and BTEC qualifications. This support is available through a choice of training options offered in our published training directory or through customised training at your centre.

The support we offer focuses on a range of issues including:

planning for the delivery of a new programme

planning for assessment and grading

developing effective assignments

building your team and teamwork skills

developing student-centred learning and teaching approaches

building functional skills into your programme

building effective and efficient quality assurance systems.

The national programme of training we offer can be viewed on our website (www.edexcel.com/training). You can request customised training through the website or by contacting one of our advisers in the Training from Edexcel team via Customer Services to discuss your training needs.

The training we provide:

is active

is designed to be supportive and thought provoking

builds on best practice

may be suitable for those seeking evidence for their continuing professional development.

N027134 –

Spec

ific

atio

n –

Lev

el 3

NVQ

Dip

lom

a in

Lab

ora

tory

Sci

ence

(Q

CF)

–

July

2011 ©

Pea

rson E

duca

tion L

imited

2011

241

Annex

e A

: Pro

gres

sion

pat

hw

ays

The

Edex

cel qual

ific

atio

n f

ram

ewor

k fo

r th

e Sc

ience

sec

tor

Level

Gen

era

l q

uali

fica

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Annexe B: Quality assurance

Key principles of quality assurance

A centre delivering Edexcel qualifications must be an Edexcel recognised centre and must have approval for qualifications that it is offering.

The centre agrees, as part of gaining recognition, to abide by specific terms and conditions relating to the effective delivery and quality assurance of assessment. The centre must abide by these conditions throughout the period of delivery.

Edexcel makes available to approved centres a range of materials and opportunities to exemplify the processes required for effective assessment and provide examples of effective standards. Approved centres must use the guidance on assessment to ensure that staff who are delivering Edexcel qualifications are applying consistent standards.

An approved centre must follow agreed protocols for: standardisation of assessors; planning, monitoring and recording of assessment processes; internal verification and recording of internal verification processes and dealing with special circumstances, appeals and malpractice.

Quality assurance processes

The approach to quality assured assessment is made through a partnership between a recognised centre and Edexcel. Edexcel is committed to ensuring that it follows best practice and employs appropriate technology to support quality assurance processes where practicable. The specific arrangements for working with centres will vary. Edexcel seeks to ensure that the quality-assurance processes it uses do not inflict undue bureaucratic processes on centres, and works to support them in providing robust quality-assurance processes.

The learning outcomes and assessment criteria in each unit within this specification set out the standard to be achieved by each learner in order to gain each qualification. Edexcel operates a quality-assurance process, designed to ensure that these standards are maintained by all assessors and verifiers.

For the purposes of quality assurance, all individual qualifications and units are considered as a whole. Centres offering these qualifications must be committed to ensuring the quality of the units and qualifications they offer, through effective standardisation of assessors and internal verification of assessor decisions. Centre quality assurance and assessment processes are monitored by Edexcel.


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The Edexcel quality-assurance processes will involve:

gaining centre recognition and qualification approval if a centre is not currently approved to offer Edexcel qualifications

annual visits to centres by Edexcel for quality review and development of overarching processes and quality standards. Quality review and development visits will be conducted by an Edexcel quality development reviewer

annual visits by occupationally competent and qualified Edexcel Standards Verifiers for sampling of internal verification and assessor decisions for the occupational sector

the provision of support, advice and guidance towards the achievement of National Occupational Standards.

Centres are required to declare their commitment to ensuring quality and appropriate opportunities for learners that lead to valid and accurate assessment outcomes. In addition, centres will commit to undertaking defined training and online standardisation activities.


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Annexe C: Centre certification and registration

Edexcel Standards Verifiers will provide support, advice and guidance to centres to achieve Direct Claims Status (DCS). Edexcel will maintain the integrity of Edexcel QCF NVQs through ensuring that the awarding of these qualifications is secure. Where there are quality issues identified in the delivery of programmes, Edexcel will exercise the right to:

direct centres to take action

limit or suspend certification

suspend registration.

The approach of Edexcel in such circumstances is to work with the centre to overcome the problems identified. If additional training is required, Edexcel will aim to secure the appropriate expertise to provide this.

What are the access arrangements and special considerations for the qualifications in this specification?

Centres are required to recruit learners to Edexcel qualifications with integrity.

Appropriate steps should be taken to assess each applicant’s potential and a professional judgement should be made about their ability to successfully complete the programme of study and achieve the qualification. This assessment will need to take account of the support available to the learner within the centre during their programme of study and any specific support that might be necessary to allow the learner to access the assessment for the qualification. Centres should consult Edexcel’s policy on learners with particular requirements.

Edexcel’s policy on access arrangements and special considerations for Edexcel qualifications aims to enhance access to the qualifications for learners with disabilities and other difficulties (as defined by the 1995 Disability Discrimination Act and the amendments to the Act) without compromising the assessment of skills, knowledge, understanding or competence. Please refer to Access Arrangements and Special Considerations for BTEC and Edexcel NVQ Qualifications for further details. www.edexcel.com.


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Annexe D: Assessment requirements/strategy

Introduction

Semta, the Sector Skills Council for the Science Engineering Manufacturing Technologies

Sector, has produced this QCF Unit Assessment Strategy to:

assist Assessors, Internal Verifiers and External Verifiers

encourage and promote consistent assessment of NVQ units

promote cost effective assessment plans

This document also provides definitions for:

the qualifications and experience required for Assessors and Verifiers

the assessment environment and notes on simulation/replication.

access to units

and requirements relating to:

carrying out assessments

performance evidence

assessing knowledge and understanding

The importance and value in which employers and learners place on undertaking NVQ units will provide a key measure of [Semta’s] success with this unit assessment strategy. Another key success factor will be [Semta’s] partnership with the relevant Awarding Organisations.

Assessor Requirements to Demonstrate Effective Assessment Practice

Assessment must be carried out by competent Assessors that as a minimum must hold the QCF Level 3 Award in Assessing Competence in the Work Environment. Current and operational Assessors that hold units D32 and/or D33 or A1 and/or A2 as appropriate to the assessment being carried out, will not be required to achieve the QCF Level 3 Award as they are still appropriate for the assessment requirements set out in this Unit Assessment Strategy. However, they will be expected to regularly review their skills, knowledge and understanding and where applicable undertake continuing professional development to ensure that they are carrying out workplace assessment to the most up to date National Occupational Standards (NOS)

Assessor Technical Requirements

Assessors must be able to demonstrate that they have verifiable, relevant and sufficient technical competence to evaluate and judge performance and knowledge evidence requirements as set out in the relevant QCF unit learning outcomes and associated assessment criteria.


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This will be demonstrated either by holding a relevant technical qualification or by proven industrial experience of the technical areas to be assessed. The assessor’s competence must, at the very least, be at the same level as that required of the learner(s) in the units being assessed.

Assessors must also be:

Fully conversant with the Awarding Organisation’s assessment recording documentation used for the QCF NVQ units against which the assessments and verification are to be carried out, other relevant documentation and system and procedures to support the QA process.

Verifier Requirements (internal and external)

Internal quality assurance (Internal Verification) must be carried out by competent Verifiers that as a minimum must hold the QCF Level 4 Award in the Internal Quality Assurance of Assessment Processes and Practices. Current and operational Internal Verifiers that hold internal verification units V1 or D34 will not be required to achieve the QCF Level 4 Award as they are still appropriate for the verification requirements set out in this Unit Assessment Strategy. Verifiers must be familiar with, and preferably hold, either the nationally recognised Assessor units D32 and/or D33 or A1 and/or A2 or the QCF Level 3 Award in Assessing Competence in the Work Environment.

External quality assurance (External Verification) must be carried out by competent External Verifiers that as a minimum must hold the QCF Level 4 Award in the External Quality Assurance of Assessment Processes and Practices. Current and operational External Verifiers that hold external verification units V2 or D35 will not be required to achieve the QCF Level 4 Award as they are still appropriate for the verification requirements set out in this Unit Assessment Strategy. Verifiers must be familiar with, and preferably hold, either the nationally recognised Assessor units D32 and/or D33 or A1 and/or A2 or the QCF Level 3 Award in Assessing Competence in the Work Environment.

External and Internal Verifiers will be expected to regularly review their skills, knowledge and understanding and where applicable undertake continuing professional development to ensure that they are carrying out workplace Quality Assurance (verification) of Assessment Processes and Practices to the most up to date National Occupational Standards (NOS).

Verifiers, both Internal and External, will also be expected to be fully conversant with the terminology used in the QCF NVQ units against which the assessments and verification are to be carried out, the appropriate Regulatory Body’s systems and procedures and the relevant Awarding Organisation’s documentation, systems and procedures within which the assessment and verification is taking place.


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Specific technical requirements for internal and external verifiers

Internal and external verifiers of this qualification must be able to demonstrate that have verifiable, sufficient and relevant industrial experience, and must have a working knowledge of the processes, techniques and procedures that are used in the relevant sector/occupation.

The tables on the following page show the recommended levels of technical competence for assessors, internal verifiers, and external verifiers.

Technical Requirements for Assessors and Verifiers

Position Prime activity requirements

Support activity requirements

Technical requirements (see notes)

Assessor Assessment Skills

IV Systems Technical competence in the areas covered by the QCF units being assessed

Internal Verifier Verification Skills Assessment Knowledge

Technical understanding of the areas covered by the qualifications

External Verifier Verification skills Assessment Understanding

Technical awareness of the areas covered by the qualifications

Notes

1 Technical competence is defined here as a combination of practical skills, knowledge, and the ability to apply both of these, in familiar and new situations, within a real working environment.

2 Technical understanding is defined here as having a good understanding of the technical activities being assessed, together with knowledge of relevant Health & Safety implications and requirements of the assessments.

3 Technical awareness is defined here as a general overview of the subject area, sufficient to ensure that assessment and portfolio evidence are reliable, and that relevant Health and Safety requirements have been complied with.

4 The competence required by the assessor, internal verifier and external verifier, in the occupational area being assessed, is likely to exist at three levels as indicated by the shaded zones in the following table.


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Technical Competence

Required by:

An ability to discuss the general principles of the competences being assessed

An ability to describe the practical aspects of the competence being assessed

An ability to demonstrate the practical competences being assessed

Assessor

Internal Verifier

External Verifier

Assessment Environment

The evidence put forward for this unit can only be regarded valid, reliable, sufficient and authentic if achieved and obtained in the working environment and be clearly attributable to the learner. However, in certain circumstances, simulation/replication of work activities may be acceptable.

The use of high quality, realistic simulations, which impose pressures which are consistent with workplace expectations, should only be used in relation to the assessment of the following:-

o rare or dangerous occurrences, such as those associated with health, safety and the environment issues, emergency scenarios and rare operations at work;

o the response to faults and problems for which no opportunity has presented for the use of naturally occurring workplace evidence of learners competence;

o aspects of working relationships and communications for which no opportunity has presented for the use of naturally occurring workplace evidence of learner’s competence.

Simulations will require prior approval from the specific Awarding Organisation and should be designed in relation to the following parameters: -

o the environment in which simulations take place must be designed to match the characteristics of the working environment;

o simulations which are designed to assess competence in dealing with emergencies, accidents and incidents must be verified as complying with relevant health, safety and environmental legislation by a competent health and safety/environmental control officer before being used;

o simulated activities should place learners under the same pressures of time, access to resources and access to information as would be expected if the activity was real;

o simulated activities should require learners to demonstrate their competence using real plant and equipment;


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o simulated activities which require interaction with colleagues and contacts should require the learner to use the communication media that would be expected at the workplace;

o for health and safety reason simulations need not involve the use of genuine substances/materials. Any simulations which require the learner to handle or otherwise deal with materials substances/should ensure that the substitute take the same form as in the workplace

Simulations/replications should be designed in relation to a realistic work environment, having an acceptable level of appropriate equipment and operating to Good Laboratory Practice (GLP)/Good Control Laboratory Practice (GCLP) and/or Good Manufacturing Practice (GMP)/Current Good Manufacturing Practice (CGMP) standards. It may involve the use of inert substitutes for dangerous compounds or microbiological materials.

Access to Assessment

There are no entry qualifications or age limits required by learners to undertake the NVQ units unless this is a legal requirement of the process or the environment. Assessment is open to any learner who has the potential to achieve the assessment criteria set out in the units.

Aids or appliances, which are designed to alleviate disability, may be used during assessment, providing they do not compromise the standard required.

Carrying Out Assessment

The NVQ units were specifically developed to cover a wide range of activities. The evidence produced for the units will, therefore, depend on the learners choice of “bulleted items” listed in the unit assessment criteria.

Where the assessment criteria gives a choice of bulleted items (for example ‘any three from five’), assessors should note that learners do not need to provide evidence of the other items to complete the unit (in this example, two) items, particularly where these additional items may relate to other activities or methods that are not part of the learners normal workplace activity or area of expertise.

Minimum Performance Evidence Requirements

Performance evidence must be the main form of evidence gathered. In order to demonstrate consistent, competent performance for a unit, performance evidence must be provided, and must be sufficient to show that the performance requirements of the unit have been carried out to the prescribed standards. It is possible that some of the scope items may be covered more than once. The assessor and learner need to devise an assessment plan to ensure that performance evidence is sufficient to cover all the specified scope items and which maximises the opportunities to gather evidence. Where applicable, performance evidence maybe used for more than one unit.

The most effective way of assessing competence, especially for the performance statements in relation to scope items, is through direct


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observation of the learner. Assessors must make sure that the evidence provided reflects the learner’s competence and not just the achievement of a training programme.

Evidence that has been produced from team activities, for example, cleaning equipment, is only valid when it clearly relates to the learners specific and individual contribution to the activity, and not to the general outcome(s).

Each example of performance evidence will often contain features that apply to more than one unit, and can be used as evidence in any unit where appropriate.

Performance evidence must be a combination of:

outputs of the learner’s work, such as items that have been processed or worked on, and documents produced as part of a work activity

together with:

evidence of the way the learner carried out the activities such as witness testimonies, assessor observations or authenticated learner reports, records or photographs of the work/activity carried out, etc.

Competent performance is more than just carrying out a series of individual set tasks. Many of the units contain statements that require the learner to provide evidence that proves they are capable of combining the various features and techniques. Where this is the case, separate fragments of evidence would not provide this combination of features and techniques and will not, therefore, be acceptable as demonstrating competent performance.

If there is any doubt as to what constitutes valid, authentic and reliable evidence, the internal and/or external verifier should be consulted.

Assessing knowledge and understanding

Knowledge and understanding are key components of competent performance, but it is unlikely that performance evidence alone will provide enough evidence in this area. Where the learner’s knowledge and understanding (and the handling of contingency situations) is not apparent from performance evidence, it must be assessed by other means and be supported by suitable evidence.

Knowledge and understanding can be demonstrated in a number of different ways. Semta expects oral questioning and practical demonstrations to be used, as these are considered the most appropriate for these units. Assessors should ask enough questions to make sure that the learner has an appropriate level of knowledge and understanding, as required by the unit.

Awarding Organisations may choose other methods, which must be supported by a suitable rationale

Evidence of knowledge and understanding will not be required for those bulleted items in the assessment criteria that have not been selected by the learner.

The achievement of the specific knowledge and understanding requirements of the units cannot simply be inferred by the results of tests or assignments


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from other units, qualifications or training programmes. Where evidence is submitted from these sources, the assessor must, as with any assessment, make sure the evidence is valid, reliable, authentic, directly attributable to the learner, and meets the full knowledge and understanding requirements of the unit.

Where oral questioning is used the assessor must retain a record of the questions asked, together with the learner’s answers.

Awarding Organisations may choose other methods, which must be supported by a suitable rationale.

Witness testimony

Where observation is used to obtain performance evidence, this must be carried out against the unit assessment criteria. Best practice would require that such observation is carried out by a qualified Assessor. If this is not practicable, then alternative sources of evidence may be used.

For example, the observation may be carried out against the assessment criteria by someone else that is in close contact with the learner. This could be a team leader, supervisor, mentor or line manager who may be regarded as a suitable witness to the learner’s competency. However, the witness must be technically competent in the process or skills that they are providing testimony for, to at least the same level of expertise as that required of the learner. It will be the responsibility of the assessor to make sure that any witness testimonies accepted as evidence of the learner’s competency are reliable, auditable and technically valid.

Quality Control of Assessment

General

There are two major points where an Awarding Organisation interacts with the Centre in relation to the External Quality Control of Assessment and these are:

Approval - when a Centre take on new qualifications/units, the Awarding Organisation, normally through an External Verifier (EV) ensures that the Centre is suitably equipped and prepared to deliver the new units/qualification

Monitoring - throughout the ongoing delivery of the qualification/units the Awarding Organisation, through EV monitoring and other mechanisms must maintain the quality and consistency of assessment of the units/qualification

Approval

In granting Approval, the Awarding Organisation, normally through its External Verifiers (EV) must ensure that the prospective Centre:

Meets the requirements of the Qualification Regulator

Has sufficient and appropriate physical and staff resources

Meets relevant health and safety and/or equality and access requirements


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Has a robust plan for the delivery of the qualification/units

The Awarding Organisation may visit the Centre to view evidence or may undertake this via other means.

The Awarding Organisation must have a clear rationale for the method(s) deployed

Monitoring

The Awarding Organisation, through EV monitoring and other mechanisms must ensure:

that a strategy is developed and deployed for the ongoing Awarding Organisation monitoring of the Centre. This strategy must be based on an active risk assessment of the Centre. In particular the strategy must identify the learner’s, assessors and Internal Verifier sampling strategy to be deployed and the rationale behind this

that the Centre’s internal quality assurance processes are effective in learner’s assessment

that sanctions are applied to a Centre where necessary and that corrective actions are taken by the Centre and monitored by the Awarding Organisation/EV

that reviews of Awarding Organisation’s external auditing arrangements are undertaken

Awarding Organisations are required to provide to SEMTA, on request, details of the strategies, rationales and reviews detailed above.

Notes:

a) It is recognised that some Awarding Bodies provide supplementary guidance and documentation to centres to support the quality of assessment and verification practice of N/SVQs.


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Annexe E: Additional requirement for qualifications that use the term ‘NVQ’ in a QCF qualification title

Please go to www.ofqual.gov.uk to access the document ‘Operating rules for using the term ‘NVQ’ in a QCF qualification title’.

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Publications Code N027134 July 2011 For more information on Edexcel and BTEC qualifications please visit our website: www.edexcel.com Pearson Education Limited. Registered in England and Wales No. 872828 Registered Office: Edinburgh Gate, Harlow, Essex CM20 2JE. VAT Reg No GB 278 537121

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