EQUIPMENT

Selection & Purchasing equipment

EQUIPMENT FACILITY REQUIREMENTS

Performance xtics

Cost

Reagents

Ease of use

Language of instruction

Warranty

Safety

Space (Will it fit)

Equipment acquisition

Purchase, lease, rent, donation

Conditions of contract

Request:

- Wiring diagrams

- Software diagrams

- Parts list

- Operator manual

- Installation by manufacturer

- Trial period

Before Installation Confirm vendor’s responsibilities

Establish checklist

Don’t attempt to use prior to proper installation

After equipment installation

MAINTENANCE PROGRAM

Overview:

An equipment mgt program address:

- Equipment selection

- Preventive maintenance

- Procedures for trouble shooting & repair

Implementation Assign responsibility for all equipment

Develop written policies & procedures

Maintain records

Monitor equipment mgt activities

- Ensure all procedures are followed

- Review all records routinely

- Update procedures as needed

Train all personnel on requirements & maintenance needs

Benefits High performance level

Lowers cost of repair

Reliability of results

Elimination of premature replacement of equipment (lengthens

lifespans)

Increases safety to personnel

Reduces interruption of work

Documents & records Inventory of all lab equipment

Information provided by the manufacturer on operation,

maintenance & repair activities

Records of all preventive maintenance & repair activities

Equipment Inventory log

Record: - Instrument type, model no. serial number

- Location in the lab

- Date purchased/ acquired

- Manufacturer & Vendor contact info

- warranty note, expiration date

- Spare parts list

ACCREDIATION

Why the assessment?

Recognition as delivering accurate & reproducible results

Recognition of compliance with the quality standards &

norms used for assessment

Certification (ISO/IEC 17000)

Procedure by which a third party gives written assurance that a product,

process or service conforms to specific requirements.

Accreditation (ISO 15189)

Procedure by which an authoritative body gives formal recognition that a

body or person is competent to care out specific tasks.

Licensure (Wikipedia 2007)

Granting of ability to practice provided most often by a local governmental

agency, usually based on demonstrated knowledge, training and skills.

Self-developed Standards

Develop their own accreditation requirements rather than using

internationally recognized standards.

Advantages:

- optimized for local use, recognized local strengths & weaknesses

- can be developed in progressive steps

- can lead to full international recognition

Weaknesses:

- may be narrow or biased

- may not be recognized by other organizations

CLSI

Global, nonprofit, standards-developing organization

Promotes the development and use of voluntary consensus standards and guidelines within

the health care community

Documents are developed by experts working on subcommittees or working groups

WHO

has developed several standards for disease-specific diagnostic laboratories,

such as polio, tuberculosis, influenza, measles

International bodies include:

ISO World's largest developer and publisher of international standards

Standards are applicable to many kinds of organizations including clinical and public health

laboratories

CEN European Committee for Standardization

National standards bodies in the European Economic Community and associated countries

General terms include openness and transparency, consensus, and integration

Good Clinical Laboratory Practice

The scheme involves the assessment of a clinical laboratory which

undertakes the analysis of samples from clinical trials, to assess

compliance with the Good Clinical Laboratory Practice (GCLP) standard,

as published by the British Association of Research Quality Assurance

(BARQA), 2003 ISBN 1-904610-00-5

This is a quality system for laboratories that analyse samples from

Clinical Trials in accordance with Good Clinical Practice (GCP)

regulations

Elements of an Accreditation Process

Accreditation Body

Standards

Assessors

User laboratory

Examples: commonly used standards

Certification standards

- ISO 9001:2000

- ISO 14000

Accreditation standards

- ISO 17025

- ISO 15189

- WHO polio standards

Regulations

- US CLIA Regulations

- French GBEA

- UN Transport of Dangerous Goods Regulations

Accreditation outcomes

Strength and integrity of the quality system are measured

Continual monitoring of the quality system

Recognition for efforts

Accredited laboratories tend to: Perform better on proficiency testing

Are more likely to have a working quality management system

SUMMARY Standards provide guidelines that form the basis for quality

practices. They are developed by organizations.

Accreditation and certification are processes that recognize

that a laboratory is meeting the designated standards.

An active quality management program can assure the

laboratory is in a constant state of “accreditation-readiness”.

Accreditation is an important step in the continual

improvement of the quality management system.

It is an accomplishment to be accredited; it is an achievement

to maintain accreditation.

GOOD

DOCUMENTATION

PRACTISE

Definition

Documentation has been defined as all records in any form

(written, electronic data) that describes or records the

methods, conduct and/or results of a trial, the factors affecting

a trial and the actions taken

Good Documentation Practice refers to concise, legible,

accurate and traceable records

Principles of Good Documentation Practice Attributable

- It should be clear, who has documented the data

Legible

- Readable and signatures identifiable

Contemporaneous

- Info should be noted in the correct time frame along with the flow of events. Delay should be defined & justified

Original

-Original, if not original should be exact copy; the first record made by the appropriate person. The investigator should have the original source document.

Accurate

-Accurate, consistent and real representation of facts

Ensure proper documentation by knowing your study

- Protocol

- CRF guidelines

- Lab procedures

- Regulations

Data are complete, accurate, legible and timely

Items (data fields) are completed per CRF completion guidelines

Errors are corrected following good documentation practices

Cont

Always use permanent ink

Write legibly

Write responses in ALL CAPS in the boxes or lines provided

Do not type data; handwrite it

Never use correction fluid

Pay attention to bolded instructions

Avoid making unnecessary marks

Keep responses in margins and space provided