Medical Laboratory Scientists-Consecrate

Sejojo Phaaroe

AMLSL President and Lesotho Medical Laboratory Regulatory Council- Focal person

1st Health Professionals Symposium 2012

Oath of a medical laboratory technologist/Scientist

• I solemnly pledge myself to consecrate my life to

the service of humanity by generating Quality information and services

• I will preserve the Safety, dignity and privacy of patients’ and others

• I will lead my life and practice my profession in uprightness and honor

• I will exercise my profession solely for the benefit of humanity and perform no act for a criminal purpose

Cont

• I will be loyal to the profession of medical laboratory science

• I will maintain and promote standards of excellence in performing and advancing the art and science of medical laboratory technology

• I will seek to establish cooperative and respectful working relationships with other health professionals

• I make these promises solemnly, freely, and upon my honor.

Practice un- licensed

Release of non reliable results

Take unlawfully patient’s money

Any Crime

Mull-practice

Any unlawfull

Scandal

Un-harmonised

working relations

Misconduct Discriminate patients Belief /

Religion

Fraud Bioterrorism Ethnic / social

discrimination

Significance & Meaning of the consecrate

Med Laboratory Scientists should not be one of the

Following puzzle?

Significance & Meaning of the consecrate

• All the world is a laboratory to the inquiring mind. Martin H. Fischer • Non-Bioterrorist act, Safety to Patient and others comes first as we use

chemicals, Microorganisms and biological organs and hence behave like professionals.

• Integrity , honesty, trust is on our operations and reliable results to successfully treat and monitor patient’s treatment

• Behind every specimen lies the life of a Patient , careful handling and quality assurance procedures are mandatory before the results are validated, and they should reflect a true state of the patient

• Litigation is possible if professionals are negligent. • our work is of a humanitarian , we do not have to steal from sick

patients • We pledge to practice with safety, professionalism , and harmony with

our colleagues' and other health professionals • We pledge to continue inquiring new discoveries that will benefit , but

not to harm or robe mankind through Ethical considerations. • We are the Fact Factory.

Client tale • Insurances • Drs • Food Handlers • Travellers • Job SEEKERS • Marriage couples • New born • ANC, • FP, • PATIENTS • Priv Doctors • Community • Criminal investigations • Legal agencies

• Out patients • Health programs • Government

departments • Health planners • Development

partners • Economic planners • Health planners • Donor agencies • Bond contractor's

• “The Medical Laboratory is a place where , under rather difficult conditions , we create a protected island where together with our younger collaborators , we use all our mental power and energy , to be an active part of medical development and to enjoy the thrill of new discoveries in modern science to benefit mankind”. Sejojo Phaaroe

• Brancusi "Endless Column", science is infinite; science has no limit , no frontiers, no borders, Just like the "Endless Column", science is a continuous, endless exploration to uncover nature's secrets, including our own. This is the adventure we have embarked on. Hence we pledge to be humanitarians of success.

• In a word, I consider hospitals only as the entrance to scientific medicine; they are the first field of observation which a physician enters; but the true sanctuary of medical science is a laboratory; only there can he seek explanations of life in the normal and pathological states by means of experimental analysis and facts of Facts. We are the Fact Factory: Claude Bernard

• In the laboratory there are no fustian ranks, no brummagem aristocracies; the domain of Science is a republic, and all its citizens are brothers and equals, its princes of Monaco and its stonemasons of Cromarty meeting, barren of man-made gauds and meretricious decorations, upon the one majestic level!

• — Mark Twain

• Thank you

Role of a Medical Laboratory Scientists

Regulatory Board

Sejojo Phaaroe

AMLSL President and MLS Board Focal person

Health Research & Laboratory Services

BECHMARK Know where you are and where you are going

Consensus building workshop November 2009

Demand by International Conventions • International Federation of Biomedical Laboratory

Science- (IFBLS)

• Council for International Organizations of Medical Sciences-(CIOMS)

• AMCOA –Lesotho 2008

• International Laboratory Accreditation Cooperation (ILAC)

• SADAC-EU – 2009 Lead assessors/Technical assessors

• ISO 15189 , Medical laboratories – Particular requirements for quality and competence

• documents of other RB, ( IBSM-UK, AIMS, ASCP, HPCSA, Newzeland MLS regulatory board, ZIMLS , Honk Kong RB, Malaysia Rb, Lesotho Nursing Council, Lesotho Medical Dental and Pharmacy Council,

• HOW BIG IS THE PROBLEM?

Why do we Need for

Medical Lab Regulation in Lesotho

Response?

CHALLENGES: OP ‘I s HIV – AIDS LAB WORK OVERLOADS High staff turn over Attrition , and staff shortages Foreign work seekers Professional negligence cases Private Labs, mushrooming Task shifting Increased demand for Lab testing- Insurances, employment, victims of violence, school seekers, travelling Sentinel surveys Health planning and staffing

Response?

I see how big it is but there is

nothing I can do!

Response!!!! benchmark

Medical Lab Regulatory

Science is our

workplace issue

Lets take immediate

strategic measurable

action LIKE

PROFESSIONALS !!!

Medical Laboratory Science or LABORATORY MEDICINE

is not a replacement profession -

BRAINSTORM

1. What is composition of the board

2. Where that it stand

2. Pre-service

requirements

and training

3. Facility

Licensing

4. Legal powers and functions of Board

5. Regional & International Collaboration

Consensus building workshop November 2009

Role in general

• To protect the public.

• To do this, we keep a register of professionals who meet our standards for their training, professional skills, behaviour and health.

• We will take action against registered professionals who do not meet our standards or who use a protected Medical Technologist (MT) or Medical Laboratory Scientist (MLS) title illegally

• The Dogs with no falling teeth when professional Negligence emanate

Mission of the MLS Board • To protect the public health or welfare of people of

Lesotho by ensuring that each person Licensed as a Medical Laboratory Practitioner is Competent to Practise safely

• The board shall be empowered by the Legislation with Regulatory powers to regulate the Practice of Vocational, Professional and advanced practice Medical Laboratory Scientist( Technicians, Technologists, and Scientists)

• The Board shall meet regularly to execute its responsibilities for administering the Law governing MLS Practice and Education

COMPETENCE

5.2 Person

nel

5.5

Equipment

5.4, 5.6, 5.7

Test/Calibration

Methods, Measurement

Traceability; Sampling

4.5 Subcontracting

of tests and

calibrations

INPUTS

OUTPUTS

PROBLEM SOLVING

MONITORING & IMPROVEMENT

4.2 MANAGEMENT SYSTEM

5.9 Assuring the quality of test/calibration results

4.1 Organisation

4.3 Document Control

4.4 Review of Requests, Tenders & Contracts

4.6 Purchasing Services and Supplies

5.1 General

5.3 Accommodation & Environmental

conditions

4.8 Complaints

4.9 Control of Non-conformities

4.11 Corrective Action

4.12 Preventive Action

4.10 Continual Improvement

4.14 Internal Audits

4.15 Management Review

4.7 Service to the Customer

4.13 Control of Records

5.10 Reporting the Results

Personnel Performing specific tasks

Qualified Professional

Education CBE Training Professional

Experience + Demonstrated Skills

MLS Regulatory Board License

Cont • The Board Shall employ professional and

support staff to carry out the provision of the Law along with the Policies, and regulations established by the Board

• The Board Pursues its mission by upholding minimum standard for educational programs in MLS

• Licensing qualified individuals as Medical Laboratory Scientists and Technologists

Sampling

Tests / calibrations

Specific personnel to perform:

Issue test reports/calibrations certificates

Give opinions/interpretations/ Relevance to patient management

Operate particular equipment

Keep records Include dates

Readily available

Authorisations

Competence

Continuous Educational & professional qualifications

Training

Skills

Experience

CPD + Medical Laboratory Sciences Regulatory Board

Cont

• ISO 15189 ; Article 5.1 .2 Laboratory management shall maintain records of the relevant educational and professional qualifications, training and experience and competence of all personnel

-certification or License

-reference from previous employment

-job descriptions

-records of continuing education and achievements

-competency evaluation

-provision for untoward incident or accident reports

cont

• Educating Licenced Medical Scientists regarding changes in the Law

• Investigating alleged violations and imposing appropriate discipline on the licenses of those found to be violating Board statutes, regulations, rules and Policies.

• The malpractice lawsuits

Professional qualification • The Board in collaboration with the Association will run

a programme of post-registration training and advanced qualifications to help medical Laboratory scientists to demonstrate the required knowledge and skills to advance in their careers as Technology and practice advances

• In Australia, UK , Malaysia, SA, – Professional Fellowship Programs (FIBMS) / (FIMLS) / (CFIAC) exist through research and records of publications as Professional Doctorates and are an equivalent of Ph. D

• Chartered Scientists status- C. Sci

• Professional Doctorate Vs. Ph. D discuss differences

PROFESSIONAL LEVELS & ROUTES

PROFESSIONAL DOCTORATE

MEDICAL SCIENTISTS

MEDICAL TECHNOLOGIST

MEDICAL TECHNOLOGIST

MEDICAL SCIENTISTS

MEDICAL SCIENTISTS

MEDICAL TECHNICIANS

LEVEL 1

LEVEL 2

LEVEL 3

LEVEL 4

LEVEL 1

FELLOWSHIP ( FIMLS/FIBMS /CFIAC

Ph.D. /DSc.

M. Sc./ M.Phil. Advanced Specialist Registry Diplomas .

Specialist Registry Diplomas

Certificate of Practice

Assistants

B Med Sci. (Hon.)

LEVEL 2

B Med Sci.

Dip. MLS

Cert MLS

• Research conducted by medical scientists has resulted in advanced treatments for many diseases.

Client tale • Insurances • Drs • Food Handlers • Oveaseas Travellers • Job SEEKERS • Marriage couples • New borne • ANC, • FP, • PATIENTS • Private Doctors • Community • School seekers • Legal agencies

• Out patients • Health programs • Epidemiology • Government

departments • Health planners • Development

partners • Economic planners • Health planners • Donor agencies • Bond contractor's

Eosinophilia in parasitic infestation

Laboratory frontiers-

• FNAB-cytology

• Estrogen receptors

• Genetic screening- BRCA1, BRCA2

25 cycles

1 cycle

1

step1 step 2 step 3 step 4

94

105 – fold amp of target DNA fragment

74

Synthesis of cDNA

55 Primer annealing

Temperature( Åé)

22

1 2 3 4 5

Time (min) (Sejojo Phaaroe MT CT (IAC), AIBMS)

--------------------------------------------------------------------------------------------------------------------------------------

Step 1: Denature the target double- stranded DNA fragment in the reaction

Mixture containing containing primer, dNTP, and polymerase

: 940c, 30 sec

Step2: Anneal primer to obtained single- stranded DNA: 550C, 30 sec

Step 3: Synthesize cDNA with DNA polymerase: 72oc, 1min.

Step 4: Return to step 1- to denature the amplifiedouble- stranded

DNA again to yield single- stranded DNA: 94oc, 30 sec

One set of the consecutive 1-4 steps is referred as one cycle and perform 25 cycles.

Parameters must be optimised for a target DNA fragment as the most efficient

condition for PCR varies depending on a target DNA fragment.

Detailed Method of PCR

CYTOGENETICS & INHERITANCE

LIST OF STANDARDS 1. DEFINED PROFESSIONAL LEVELS

• Medical Laboratory Scientists • - Degree in Medical Laboratory Sciences • -National Diploma in Medical Laboratory Sciences + 3

years Specialist professional training /Registry/ in a recognised institution

• - Board Examination • -Board Certified • General subject covered : anatomy and physiology,

Instrumentation, cell biology, biochemistry, genetics, molecular biology, immunology, Pathophysiology, Quality Management Essentials , Research Methology

• • specialist subjects: Medical Microbiology,

Histopathology, Clinical Biochemistry, Clinical Immunology, Clinical Haematology, Blood Transfusion Sciences, Molecular Pathology , Cytopathology.

Medical Laboratory Technologist • Diploma Medical Laboratory Sciences

• Board Examination

• Board Certified

• General subject covered : anatomy and physiology, cell biology, biochemistry, genetics, Instrumentation ,molecular biology, immunology, Pathophysiology, Quality Management Essentials, Project

• Medical Laboratory Sciences : : Medical Microbiology, Cellular pathology, Clinical Biochemistry, Haematology, Blood Transfusion Sciences.

Medical Laboratory Technicians • Vocational training or trained on the Bench

• Certificate in Medical Laboratory Sciences

• Basic Medical Laboratory Sciences: haematology, Medical microbiology, clinical chemistry, Quality Management Essentials

• Board Examination

• Board Certified

2. DEFINED CRITERIA FOR INITIAL REGISTRATION OF PROFESSIONALS QUALIFIED INSIDE AND OUTSIDE

LESOTHO

• National: • - Certificate, Diploma or Degree as above obtained from

approved institutions that are Board Certified. • - Completion of Board approved Manual during in-service

training • -Passed the Board Examination • International: • - Diploma or Degree obtained from approved institutions that are

Board certified in the Country of Origin. • -Currently Registered in the Country of Origin • - Reciprocity of Qualifications • - If a candidate comes from a Country which does not appear in

the International Directory of Medical Laboratory Science Education of IFBLS they should Pass Lesotho Board Examination

3. LEVELS OF REGISTRATION – LICENSING

• Students

• National Students from approved institutions that are Board Certified.

• International Students from approved institutions that are Board Certified in the country of origin.

• Qualified Professionals

• Qualified graduates with board certificate

• International qualified graduates with current board certificate in the country of origin which appears in the IFBLS Directory .

4. ESTABLISH BOARD EXAMINATIONS

• - Board Examinations shall be conducted for all levels of professional Practitioners.

5. PRESCRIBE CODE OF CONDUCT

• The code of conduct covers prohibitions and professional Conduct performance and ethics within which Medical Laboratory Practitioners work in relation to patient expectation, limitations and confidentiality. The ethical framework within which a Medical Laboratory Practitioners concerned with

• -interpretation and application of Board Registration • - Continuous Professional Development • - Advertising and canvasing or touting • -information on professional stationery • -Naming of the Practice • -fees and commission • -Partnership and Juristic persons • -Professional reputation • -professional confidentiality • -Retention of Human organs • -Signing official documents • -Professional Appointments • -Defeating and or obstructing the Board in the performance of its duties • - Performance of The Professional acts • - Exploitation • -Financial Interest

Reporting of Impairment or of Unprofessional, illegal or unethical Conduct -Research, development and use of chemical, nuclear and Biological capabilities. -Dual registration - Repeal -Patients right charter

6. SET CRITERIA FOR CONTINOUS PROFESSIONAL DEVELOPMENT (CPD) AND ONGOING COMPETENCY

• CPD is the means for maintaining and updating professional competence, to ensure that the public interest will be always promoted and protected, as well as ensuring the best possible service to the community.

• CPD should address the emerging health needs and be relevant to the health priorities of Lesotho

• Maintaining, updating and improving competence

7. CPD CRITERIA

• - CPD is required over a twelve month period and is requisite for Re-registration.

• - CPD points shall be set according to level of professional practitioners as well as type of CPD approved activity.

• - CPD service providers shall be approved by the Board.

• - CPD shall be self-monitored by the individual registered professional practitioner.

8. DEFINE CRITERIA FOR HANDLING PROFESSIONAL MISCONDUCT or LAW

SUITS

• The purpose of malpractice lawsuits is to hold professionals accountable while securing appropriate compensation for losses and suffering. Since a Statute of Limitations may apply to malpractice lawsuits—usually within two years--the victim or the victim's loved ones should file a complaint as soon as possible

• 9. ONGOING, RE-REGISTRATION AND DE-REGISTRATION

• • A person shall not be entitled to practise in medical laboratories

within Lesotho unless he/she is currently board certified. • Renewal fee shall be payable annually. • Re-registration fees shall be applicable. • On-going and re-registration shall be on the basis of CPD

compliance and proof of good conduct. • Circumstances of de-registration • Professional misconduct • Payment failure of membership fee • CPD non-compliance

10. CRITERIA FOR PRE-SERVICE EDUCATIONAL CURRICULUM

–All curricula, graduation criteria and training institutions shall be board approved.

–All institutional faculty shall be Board approved in collaboration with CHE

–The Board shall enforce adherence to set standards within the approved curriculum.

–The Board shall provide a current list of approved training institutions, curricula and qualifications.

•

case1BLOOD TRANSFUSION REACTION • A Medical Laboratory Technologist is working night

duty, and he gets a bell notice and a porter gives him blood to perform a x-match for blood transfusion. The Patients request form is written urgent with a diagnosis of Road traffic accident. The Doctor Follows the Blood request sent by the Porter and ask the Technologist to urgently process 4 Units of Blood as the Patient is Pale and bleeding massively . A technologist performs a group which is group A and decide to give all 3 units labelled group A without performing x-matching techniques because the Doctor is Nailing him and he is lethargic he needs a sleep. The Units of Blood are transfused but later the Patient develops transfusion reactions

• Analyse the scenario .

Case 2 • It is Early January, Food handlers attend the

Public Health screening clinic before they could receive the School feeding and Catering contract and are sent to the Laboratory for Widal test, VDRL and Stool culture . The Widal test of One of the handler test Positive , so she bribes the Laboratory Technologist to report it falsely as Negative as she desperately needs to win a school feeding tender.

• An out break of Typhoid erupts in one of the schools when the school open late January and vertical investigations continue.

• What would be the ethical case scenario and consequences of the case. ?

A false Positive Pap Smear

• Analyse the scenarion? • Unnecessary surgery • Death • Drug toxicity

• A false negative , follow up TB smear • -drug resistance • Relapse • Community spread • Death

Case 3 • A laboratory practitioner is working night duty and

receive a request to perform a test of Urea , Na, Cl, and Creatinine ,and blood glucose to a patient

• The Technologist does not know how to operate the chemistry analyser and writes K+ results within the normal range when the Doctor requests urgently release of the results . A patient was found unconscious , in a park, and she has been sent by the municipal with an emergency umbulance to Mamohato Memorial Hospital and was put on IV line when further investigations are carried

• What would be the consequences of the scenario if the patient truly had hyperkalaemia?

Case 4.

• Context.-Shigella dysenteriae type 2 is rare in the United States, and outbreaks associated with this pathogen are uncommon.

• Objective.- To determine the magnitude and source of an outbreak of S dysenteriae type 2.

• Design.-Retrospective cohort.

• Setting.-Laboratory of a large medical center .

• Patients.-Case patients were identified as laboratory workers who had diarrhea on or after October 28 and a positive stool culture or temperature greater than 37.8°C. Laboratory workers with diarrhea only were probable case patients.

• Main Outcome Measures.-We interviewed laboratory staff and performed identification, serotyping, and pulsed-field gel electrophoresis on isolates from case patients, implicated food, and laboratory stock culture.

• Results.-From October 29 through November 1, a total of 12 (27%) of 45laboratory staff developed severe, acute diarrheal illness; 8 had S dysenteriae isolated from stool and 4 were hospitalized. All case patients reported having eaten muffins or doughnuts placed in the staff break room on October 29. Pulsed-field gel electrophoresis

• showed stool isolates from 9 case patients were indistinguishable from S dysenteriae type 2 recovered from an uneaten muffin and from the laboratory's stock strain, a portion of which was missing.

• Conclusions.- The source of the outbreak was most likely the laboratory's stock culture, which was used to contaminate the pastries. Results of this investigation underscore the need for adequate precautions to prevent inadvertent or intentional contamination from highly pathogenic laboratory specimen

• An Outbreak of Shigella dysenteriae Type 2 Among Laboratory Workers Due to Intentional Food Contamination (JAMA, 1997)

• A large community outbreak of salmonellosis caused by intentional contamination of

restaurant salad bars JAMA 1997 Aug 6;278(5):389-95 (ABSTRACT)

• An Outbreak of Shigella dysenteriae Type 2 Among Laboratory Workers Due to Intentional Food Contamination (JAMA, 1997

THE ROAD AHEAD NOW?

• THANK YOU FOR LISTENING

Association of Medical Laboratory Scientists of Lesotho • “advanced technology advances Health” • Registered since 1993

The Role of Medical Laboratory Scientists (Professional) Association-

AMLSL •

Unlike the MLS BOARD , a AMLSL (also called professional association(s) is a private organization whose members must pay dues to enjoy the benefits of membership.

• One of the primary functions of a MLS association is to represent its members in legislative, political and practice matters.

• It provides a central voice for its MLS membership.

cont

• An association can lobby for the interests of its members and the profession of MLS.

• AMLSL provides a united voice that can speak out on the issues important to a specific area of MLS practice and/or to the MLS profession as a whole.

• In addition, a MLS provides leadership in other areas such as improving working conditions and benefits for MLS Scientists.

• AMLSL also may lead the way in developing public health policies and educational continuous professional development

Cont • Members pay dues to enjoy membership

benefits- journal, congress fees, discounts travel • Primary function od AMLSL:- To represent

members in legislative, education, political and practice matters

• It’s a Mouth Piece of Profession • It Provides Central Voice for its Medical Scientists

Membership • It can lobby the legislature for the interest of its

members • Provides a united voice that can speak out on

issues important • It promotes professionalism and standards

• It provides a platform of networking, learning and sharing

• Promote Education and practice standards • Organises congresses • CPD schemes • Bench marks • Market and promote the profession • Harmonised environment • International , Regional, National cooperation • Forecast

cont • Advocacy

• Careers

• Provide information relevant to all walks of Laboratory Medicine

• Motivate professionals and give them certificate of recognition

• Public Journal

• to provide personal and professional support such as Discounts , bank cards, travel discounts , cash advances, arranged car advances, insurances

• Thank you

Cyanides-Overview

• HCN and CK

– Highly volatile

– Easily dispersed as aerosols

– Readily soluble and stable in water

– Major route of toxicity is inhalation

– Aroma of bitter almonds or marzipan

– CK has cumulative effect on victims

Cyanides-Toxicity

• Inhibits oxidizing enzymes containing ferric iron, mainly cytochrome oxidase

• Interferes with aerobic respiration

• Lactic acid accumulates and cells die from a histotoxic anoxia

• Alters calcium metabolism

Cyanides-Toxicity

• Hydrogen Cyanide (HCN)

– 60 mg•min/m3 - No serious symptoms

– 200 mg•min/m3 - Fatal after 10 minutes

– Above 2,500 mg•min/m3 - death within a minute

Protective Equipment

• Chemical protective clothing required

• Respirator filters containing silver oxide offer effective protection

– Change filter immediately after exposure

Signs and Symptoms

• Diagnosis – History

– Abrupt onset of symptoms

– Bitter almond odor on the breath

• Mild HCN cases – Headache

– Vertigo

– Nausea

Signs and Symptoms

• Low HCN concentrations – Apprehension, dyspnea, headache, vertigo and a

metallic taste are seen initially

– Convulsions and coma may follow and can last for hours or days

Signs and Symptoms

• High concentrations

– Throat constriction, giddiness, confusion, decreased vision, vice-like gripping of the temples, and pain in the back of neck and chest

– If unconsciousness follows, further exposure can be fatal within 2-3 minutes

Signs and Symptoms

• Very high concentrations

– Main initial symptom: hyperventilation

– Loss of consciousness, convulsions, and loss of corneal reflex

– Death by cardiac and/or respiratory arrest