There is an urgent need for professional regulation in the region , because of staff mobilty, and professional demands and aspirations for continous professional development and harmony in ethical practices. Lesotho Medical Regulatory Council is advocated , and this will operate within the Legal Framework of the Health Professional Council

1. overview of Medical Laboratory Regulatory
Council, Objectives , progress report, workshop
expectations
Sejojo Phaaroe
Medical Laboratory Regulatory Council- Focal Person

2. Introduction
• Medical laboratories, both public and private, provide
essential services to patient care through clinical
diagnosis and monitoring of treatment for all patients.
• There is currently no regulatory authority in Lesotho
to comprehensively regulate medical laboratory
professionals, their training and practice including
facilities.
• Establishment of a regulatory authority will assist in
the protection towards a healthy general public.
• The Medical Laboratory Policy has recognized this and
recommends for the establishment of a Regulatory
Council , to regulate medical laboratory practice
including registration of personnel, setting standards
and licensing facilities and development and
enforcement of professional code of conduct.

3. Vision
• A healthy public within the Kingdom of
Lesotho, assured through the provision of
quality medical laboratory services operating
at the highest professional standards, that is
accessible and affordable to all.

4. Mission
• To protect public health and safety through
licensing and regulation of professional medical
laboratory personnel, laboratory practice and
medical laboratory facilities of Lesotho by:
• Facilitating affordable quality education and
training of the profession
• Promoting an accessible system for continued
professional development
• Monitoring and regulation of professional
practice, and scopes of practice, including
enforcement of professional ethics
• Continuously promote high professional
standards of a Practice and facilities

5. Progress to date
• Medical Regulatory Board Policy has been
developed and validated by stakeholders
• Strategic Plan has been developed and validated
by stakeholders
• Funding Proposal has been drawn ,
• Guidelines , Rules and regulations have been
developed and validated by all stakeholders
• Sensitization of professionals and networking
with other health professionals has been run
through symposia
• Documents dissemination has been done to all
Laboratory Heads , for them to step down the
dissemination

6. Where are we heading?
organizational QMS
QMS
Personel
training facilities
environment
safety
lab facilities accreditation
lab persnel
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%

7. ROLE OF COUNCIL ROLE OF ASSOCIATION
• Its autonomous in Legislature , enacted in • Is an organization whose members must pay dues to
Parliament , it protect the public. has suing enjoy the benefits of membership?
powers and it can be sued
• Keep a register of professionals who meet our • One of the primary functions of an AMLSL is to
standards for their training, professional skills, represent its members in legislative, Professional
behaviour and health. and practice matters.
• take action against registered professionals who • It provides a central voice for its MLS membership.
do not meet our standards or who use a • Lobby for the interests of its members and the
protected Medical Technologist (MT) or Medical profession of MLS.
Laboratory Scientist (MLS) title illegally
• To protect the public health or welfare of people • AMLSL provides a united voice that can speak out on
of Lesotho by ensuring that each person Licensed the issues important to a specific area of MLS
as a Medical Laboratory Practitioner is Competent practice and/or to the MLS profession as a whole.
to Practise safely • It can lobby the legislature for the interest of its
• The Dogs with no falling teeth when professional members
Negligence emanate
• empowered by the Legislation with Regulatory • AMLSL provides leadership in other areas such as
powers to regulate the Practice of Vocational, improving working conditions and benefits for MLS
Professional and advanced practice Medical Scientists.
Laboratory Scientist( Technicians, Technologists, • AMLSL also may lead the way in developing public
and Scientists) health policies and educational continuous
professional development

8. • empowered by the Legislation with • AMLSL provides leadership in other areas such
Regulatory powers to regulate the Practice of as improving working conditions and benefits for
Vocational, Professional and advanced MLS Scientists.
practice Medical Laboratory Scientist( • AMLSL also may lead the way in developing
Technicians, Technologists, and Scientists) public health policies and educational
continuous professional development
• Investigating alleged violations and imposing • Give indemnity insurance services
appropriate discipline on the licenses of those
found to be violating Board statutes, regulations,
rules and Policies. The malpractice lawsuits
• Licentiates pay annual Practising fees • Members pay dues to enjoy membership
benefits- journal.
• Regulate compliance to Professionalism and • It promotes professionalism and standards
investigate breaches of standards
• The Board Shall employ professional and • Organises Scientific congresses in MLS
support staff to carry out the provision of the • Voluntary social contact of a professional
Law along with the Policies, and regulations expects
established by the Board
• The Board Pursues its mission by upholding • CPD schemes
minimum standard for educational programs
in MLS and maintenance of CPD
• Licensing qualified individuals as Medical • Bench marks , Market and promote the
Laboratory Scientists and Technologists profession
• Harmonise environment world wide • Harmonise environment
• International , Regional, National cooperation • International , Regional, National cooperation

9. Med Laboratory Scientists should not be one of the
Following puzzle?
Corruption Any
Release of non unlawfull
reliable results
Practice un- Mull-
Take unlawfully
licensed practice Scandal
patient’s money
Ethnic / social
Discriminate Bioterrorism discrimination
Neglegence patients
Fraud
Misconduct Belief /
Religion

10. PUBLIC HEALTH BILL 2013
• PART IV: STRUCTURE FOR INTEGRATED HEALTH SERVICE DELIVERY 29
-DECENTRALIZATION OF HEALTH SERVICES-INTERGRATED HEALTH CARE
NETWORKS
-establishment of uniform standards of health care and health care service
delivery, including specific objectives and targets for the Ministry for Health, district
health councils and categories of public, private, non-governmental and charitable
health care establishments, management and personnel, to ensure delivery of health
care services within the integrated national health care network;
- near patient Lab testing ( Point of care )- level 1
• PART IX: SECTOR WIDE APPROACH 67
-“SWAp” means the sector-wide approach by and among the Ministry for
Health and its SWAp partners as specified in section 45(1) to harmonise funding for
health services from the annual and supplementary health appropriations in the
Consolidated Fund or other public money and from the Government’s development
partners, including but not limited to international donors, non-governmental and
non-profit organisations;
• PART X: HUMAN RESOURCES FOR HEALTH 72
-Human Resources for Health Policy and Guidelines 73
-Regulations for Human Resources for Health 73
-Establishment of Health Professions Board 74
- Medical Laboratory , Nursing , Medical Dental, Council, Pharmacy Councils
etc. , will be under this legal control framework

11. • Roster of Public, Private, Non-Governmental and
Charitable Health Establishments 74.
• Health Establishment Regulations, Rules and
Guidelines 79
• Classification and Certification of Public Health
Establishments/ Facilities 81
• Classification and Registration of Private, Non-
Governmental and Charitable Health
Establishments 83
• PART XXVI: CONTROL OF USE OF BLOOD, BLOOD
PRODUCTS, TISSUE AND GAMETES IN HUMANS
155

12. Why Minimum Standards for Medical
Laboratories
• The establishment of a Medical Laboratory
Regulatory Council (onwards referred to as
“the Council”) is necessary to regulate
Medical Laboratory Services
• regulate Medical Laboratory facilities
• regulate Medical Laboratory personnel as
articled in the Laboratory Policy
• Regulate Medical laboratory training facilities

13. List of Documents and standards we
review
• International conventions
• MDG’s and Vision 2020
• Horizon 2020
• WHO SLIPTA Minimum standards
• International Standards – ISO 9001
-ISO 17025
-ISO15189
-ISO 15000
 Public Health Bill 2012
 Health Professions Council bill 2012
 Laboratory Policy
 Laboratory Strategic Plan

14. Regulation and Supervision in the Market
Accreditation Bodies/ regulatory bodies
Accreditation service/ regulatory activities
Conformity assessment bodies
Certification Inspection Test Cal
Body Body Lab Lab
Conformity Assessment Service
Market
Conforming Demands for
Product/ product/service Purchasers competent
service Requirements Regulators conformity
assessment
Trade
Suppliers Demands for
Organizations facilitating
and Authorities trade

15. 4.2 Develop and manage a Professional 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

16. Personnel
Performing specific Medical Laboratory tasks
Qualified Professional
+
Demonstrated
CBE Training
Education Experience Skills + Passed
Professional
Different Board Exams
MLS Regulatory Board License + Professional Qualifications/ Credentials

17. Specific personnel to perform:
Sampling
Tests / calibrations
Keep records
Include dates Issue test reports/calibrations certificates
Readily available
Give opinions/interpretations
Authorisations
Competence Operate particular equipment
Training
Skills
Experience
Educational & professional qualifications
Minimum Standards : Areas of personnel assessment for competency

18. Regulatory Council and documents dissemination to all Facilities Public and
Private At Blue Mountain Inn- Berea 01-03 October 2012
Time Table Day 1
01-10-2012
Time Topic / Activity By Whom
08:00-08: 30 Registration
08:-30-08:45 Official opening DLS
08:45-09:00 Introduction , Objectives of the workshop and expectations Sejojo Phaaroe
09:00-09:45 The role of a Professional Association
09:45-10:15 The Role of a Professional Council Sejojo Phaaroe
10:15- 10:45 Discussions
10:45-11:15 TEA
11:15-12: 45 Critical review of Health Professions Bill Zero Draft All
12:45-14:00 LUNCH
14:00-15:00 Critical review of Health Professions Bill Zero Daft All
15:00-16:15 Correlation , Extraction of Minimum standards and Discussions Sejojo Phaaroe
16:15- 16: 30 TEA
16:30 Close

19. Stakeholders Workshop on development of Minimum standards for a Medical
Laboratory Regulatory Council and documents dissemination to all Facilities Public
and Private At Blue Mountain Inn- Berea 01-03 October 2012
Day 2 time Table
02-10-2012
Time Topic / Activity By Whom
08:00-08: 30 Registration
08:-30-08:45 Group Repertoire Groups
08:45-09:00 Overview of a Medical Laboratory Policy and strategy Ms Tsietso Motsoane
09:00-09:45 Review of Medical Laboratory Council , structures and function Sejojo Phaaroe
09:45-10:15 Discussions and extraction of Minimum Standards All
10:15- 10:45 Review of Medical Laboratory Rules and Regulations Sejojo Phaaroe
10:45-11:15 TEA
11:15-12: 45 Discussions and extraction of Minimum Standards groups
12:45-14:00 LUNCH
14:00-15:00 Review and comparison of ISO Standards Groups
15:00-16:00 Group Repertoires
16:00 TEA and Closure

20. Stakeholders Workshop on development of Minimum standards for a Medical
Laboratory Regulatory Council and documents dissemination to all Facilities Public
and Private
At Blue Mountain Inn- Berea 01-03 October 2012
Day 3
Time Topic / Activity By Whom
08:00-08: 30 Registration
08:-30-08:45 Group Repertoire
08:45-09:00 Management and Managing aspects of a health system Sejojo Phaaroe
09:00-09:45 Communication channels in public services HR
09:45-10:15 Discussions All
10:15- 10:45 Recruitment and selection process in public services HR
10:45-11:15 TEA BREAK
11:15-12: 45 code of conduct 2008 , and Employment benefits in public services HR
Discussions HR
12:45-14:00 LUNCH
14:00-15:00 Presentation of Minimum standards extracts Sejojo Phaaroe
15:00 Way forward and assignments to each participants Sejojo Phaaroe

21. Minimum Standards for Laboratory
Facility Licensing
• Develop the 12 minimum standards and fill a
gap to suit our environment
• Later develop checklist and tools for licensing
medical laboratory facilities and training
facilities
• Present them as tools for enacting our
Medical Laboratory regulatory Council , and
Gazetting them for us by regulatory
Authorities in Lesotho.

22. • Thank you