Lesotho Medical Laboratory Regulatory Council

1. Medical Laboratory Scientists-
Consecrate
Sejojo Phaaroe
AMLSL President and
Lesotho Medical Laboratory Regulatory Council- Focal person
1st Health Professionals Symposium 2012

2. 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

3. 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.

4. Significance & Meaning of the consecrate
Med Laboratory Scientists should not be one of the
Following puzzle?
Release of non Any
reliable results Any Crime unlawfull
Practice un- Take unlawfully Mull-
licensed patient’s money practice
Scandal
Un-harmonised Misconduct Discriminate Bioterrorism Ethnic / social
patients Fraud discrimination
Belief /
working
relations
Religion

5. 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.

6. Client tale
• Insurances • Out patients
• Drs
• Food Handlers • Health programs
• Travellers • Government
• Job SEEKERS departments
• Marriage couples
• New born
• Health planners
• ANC, • Development
• FP, partners
• PATIENTS • Economic planners
• Priv Doctors
• Community • Health planners
• Criminal investigations • Donor agencies
• Legal agencies • Bond contractor's

7. • “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

8. • 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.

9. • 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

10. • 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

11. • Thank you

12. Role of a
Medical Laboratory Scientists
Regulatory Board
Sejojo Phaaroe
AMLSL President and
MLS Board Focal person
Health Research & Laboratory Services

13. BECHMARK
Know where you are and where you are going
Consensus building workshop November 2009

14. 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,

15. • HOW BIG IS THE
PROBLEM?
Why do we Need for
Medical Lab Regulation
in Lesotho

16. 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

17. Response?
I see how big it is but there is
nothing I can do!

18. 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 -

19. BRAINSTORM
Consensus building workshop November 2009
5. Regional &
International
Collaboration
2. Pre-service
requirements
and training
1. What is
composit
ion of
the
board
2. Where
that it
4. Legal powers stand
3. Facility and functions of
Licensing Board

20. 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

21. 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

22. 4.2 MANAGEMENT SYSTEM
INPUTS PROBLEM SOLVING
4.1 Organisation 4.8 Complaints
4.3 Document Control 4.9 Control of Non-conformities
4.4 Review of Requests, Tenders & Contracts 4.11 Corrective Action
4.6 Purchasing Services and Supplies 4.12 Preventive Action
5.1 General
5.3 Accommodation & Environmental
conditions
COMPETENCE
5.4, 5.6, 5.7 4.5 Subcontracting
5.2 Person 5.5 Test/Calibration of tests and
nel Equipment Methods, Measurement calibrations
Traceability; Sampling
5.9 Assuring the quality of test/calibration results
MONITORING & IMPROVEMENT OUTPUTS
4.10 Continual Improvement
4.7 Service to the Customer
4.14 Internal Audits
4.13 Control of Records
4.15 Management Review
5.10 Reporting the Results

23. Personnel
Performing specific tasks
Qualified Professional
Education
CBE Training
Professional
Experience
+ Demonstrated
Skills
MLS Regulatory Board License

24. 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

25. Specific personnel to perform:
Sampling
Tests / calibrations
Keep records
Include dates Issue test reports/calibrations certificates
Readily available
Give opinions/interpretations/
Authorisations Relevance to patient management
Competence Operate particular equipment
Training
Skills
Experience
Continuous Educational & professional qualifications
CPD + Medical Laboratory Sciences Regulatory Board

26. 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

27. 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

28. 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

29. PROFESSIONAL LEVELS & ROUTES
FELLOWSHIP ( Ph.D. /DSc.
FIMLS/FIBMS /CFIAC PROFESSIONAL LEVEL 4
DOCTORATE
Advanced Specialist M. Sc./ M.Phil.
Registry Diplomas .
B Med Sci.
Specialist (Hon.)
Registry
LEVEL 3
Diplomas
MEDICAL MEDICAL MEDICAL B Med Sci.
SCIENTISTS SCIENTISTS SCIENTISTS
Certificate MEDICAL MEDICAL Dip. MLS
of Practice LEVEL 2 TECHNOLOGIST TECHNOLOGIST LEVEL 2
MEDICAL Cert MLS
Assistants LEVEL 1 LEVEL 1
TECHNICIANS

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

31. Client tale
• Insurances
• Out patients
• Drs • Health programs
• Food Handlers • Epidemiology
• Oveaseas Travellers • Government
• Job SEEKERS
• Marriage couples departments
• New borne • Health planners
• ANC, • Development
• FP,
• PATIENTS
partners
• Private Doctors • Economic planners
• Community • Health planners
• School seekers • Donor agencies
• Legal agencies
• Bond contractor's

32. Eosinophilia in parasitic infestation

35. Laboratory frontiers-
• FNAB-cytology
• Estrogen receptors
• Genetic screening- BRCA1, BRCA2

36. Detailed Method of PCR
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.

37. CYTOGENETICS & INHERITANCE

38. 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.

39. 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.

40. 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

41. 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

42. 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 .

43. 4. ESTABLISH BOARD EXAMINATIONS
• - Board Examinations shall be conducted for
all levels of professional Practitioners.

44. 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
Reporting of Impairment or of
• - Advertising and canvasing or touting
Unprofessional, illegal or unethical
• -information on professional stationery
Conduct
• -Naming of the Practice
-Research, development and use of
• -fees and commission
chemical, nuclear and Biological
• -Partnership and Juristic persons
capabilities.
• -Professional reputation
-Dual registration
• -professional confidentiality
- Repeal
• -Retention of Human organs
-Patients right charter
• -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

45. 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

46. 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.

47. 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

48. • 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

49. 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.

50. 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 .

51. 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. ?

52. 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

53. 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?

54. 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.

55. • 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

56. • 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

57. THE ROAD AHEAD NOW?

59. • THANK YOU FOR LISTENING

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

61. 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.

62. 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

63. 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

64. • 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

65. 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

69. • Thank you

72. 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

73. 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

74. 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

75. Protective Equipment
• Chemical protective clothing required
• Respirator filters containing silver oxide offer
effective protection
– Change filter immediately after exposure

76. Signs and Symptoms
• Diagnosis
– History
– Abrupt onset of symptoms
– Bitter almond odor on the breath
• Mild HCN cases
– Headache
– Vertigo
– Nausea

77. 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

78. 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

79. 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