June 9, 2015 marks World Accreditation Day as a global initiative, jointly established by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), to raise awareness of the importance of accreditation. This year’s theme focuses on how accreditation can support the delivery of health and social care. the day was celebrated across the world with the hosting of major national events, seminars, and press and media coverage, to communicate the value of accreditation to Government, Regulators and the leaders of the business community. What international support for quality improvement is available to Lesotho national health care initiatives? • To what extent do national governments around the world specify quality improvement in legislation and published policy? • What are the distinguishing structures and activities of national approaches to quality improvement within countries? • What resources (in the form of organizations, funding, training and information) are available nationally? What maintenance or implementation pathways are available , to prove to the world that Lesotho health care services are of excellence???

1. The Role of the Government in
strengthening accreditation and
Quality Heath and social care
delivery
Sejojo Phaaroe
SADCAS- Technical Advisory Committee Member
SANAS-SADCAS-EU trained Technical Assessor
MLS- REGULATORY BOARD FOCAL PERSON

3. PRESENTATION OVERVIEW
• This presentation constitutes a snapshot –,
• What is accreditation
• Why- Remove Barriers' to free trade
• World accreditation day - Advocacy for quality,
and accreditation services support in health
care in
• structures and processes that are built help to
inform local improvement of health services
• Strengthening of accreditation activities
nandsscape
• What Lesotho has been doing in the Health
sector SUPPORTING ACCREDITATION

4. June 9, 2015 marks World
Accreditation Day
• June 9, 2015 marks World Accreditation Day as a global
initiative, jointly established by the International
Accreditation Forum (IAF) and the International
Laboratory Accreditation Cooperation (ILAC), to raise
awareness of the importance of accreditation.
• This year’s theme focuses on how accreditation can
support the delivery of health and social care.
• the day was celebrated across the world with the hosting
of major national events, seminars, and press and media
coverage, to communicate the value of accreditation to
Government, Regulators and the leaders of the business
community.

5. What is accreditation?
• Accreditation is defined as the procedure by
which an authoritative body gives formal
recognition that an institution/organization/body
or person is competent to carry out specific
tasks.
• The key words from the above definition in the
process of accreditation are “authoritative”,
• formal recognition”
• “competent”, there is NO national authority in
Lesotho for granting accreditation to conformity
assessment bodies involved in calibration,
testing, inspection and certification

6. Why accreditation?
• At the international level, the purpose
of Accreditation is to remove technical
barriers to trade by ensuring that the
results of conformity assessment are
accepted and recognized among
trading partners.

7. Why accreditation
• Accreditation also improves the quality and
reliability of services provided to local users
of conformity assessment bodies and is thus
important at the national level for the
protection of the health and safety of the
population and for the protection of the
environment.
• ISO STANDARD 15189

8. Client tale
• Insurances
• Drs
• Food Handlers
• Travellers
• Job SEEKERS
• Marriage couples
• New born
• ANC,
• FP,
• PATIENTS
• Private 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

9. Proactive to Prevent
Paparatzi after a Medical Lab Scandal ?

10. International and national structures
and activities for improving health
care
• What international support for quality improvement is
available to Lesotho national health care initiatives?
• • To what extent do national governments around the
world specify quality improvement in legislation and
published policy?
• • What are the distinguishing structures and activities of
national approaches to quality improvement within
countries?
• • What resources (in the form of organizations, funding,
training and information) are available nationally?
• What maintenance or implementation pathways are
available , to prove to the world that Lesotho health care
services are of excellence???

11. International - Multilateral Recognition
Arrangement Documents (ML Series)
• purpose of IAF is to establish Multilateral Recognition
Arrangements (MLA) between its accreditation body
members in order to contribute to the freedom of world
trade by eliminating technical barriers to trade.
• cover all accreditation bodies in all countries in the world,
• thus eliminating the need for suppliers of products or
services to be certified in each country where they sell their
products or services (certified once accepted everywhere).

12. • Quality and accreditation in health
care services:
• International Society for Quality in Health Care
(ISQua) under contract to the World Health
Organization.
• structures and activities at national and
international levels around the world to promote
quality in health care.
• catalogues quality concepts
• Gives representation in International Quality
Forum . ILAC. AMCOA , SADCAS and LFL
• African Centre for Integrated Laboratory
Training (ACILT- accreditation HAS BEED
IDENTIFIED BY DEVELOPING- SMLTA as an
assistance to developing countries like Lesotho

13. Pro-active
Quality Health
management
delivery
system
Patient Sales and
marketing
Accredit
ation
Infustructure
and
equipment
Finance
/budget
s
OUT REACH
AND Education
Policy makers
Laws ; vision,
mission, values,
norms, location
Environment
and climate
change
RISK
MANAGEMENT
REGULATORY
AGENCIES
COMMUNITY
INFORMATION
mngt
International
Collaborations
Human
Resource
Job seekers
Recruitment
Public
relations
Medic
al staff

14. Health systems and programs
MDG’s
Community
involvement
Competent
motivated Health
professionals
Quality
Patients
programs

15. Health Departments
1. Administration-
2. Clinical Services
laboratory ,
pharmacy,
dental,
nursing ,
mental health, and Medical, )
2. Health Planning
3. HIV/AIDS Directorate and disease control
4. Human Resource
5. Primary Health Care
6. Procurement
7. Social Welfare

16. Call for Government strengthening
Quality health care
• Government expenditure on health has in recent years
gone toward healthcare services, improvement and
refurbishment of clinics, and other activities aimed at
addressing the effects of HIV/ AIDS and tuberculosis
(TB) and improving access to healthcare services.
• Accessibility of good quality healthcare services is a
cornerstone of Lesotho’s Vision 2020 framework.
• This combination of funding and policy emphasis has
led to infrastructure improvement in the form of new
facilities, particularly in the primary healthcare sector
THROUGH MCC.

17. GOVERNMENT SUPPORT
New public health bill
• Developing new regulations and requirements
• Measuring compliance with regulatory and legal
requirements:
• Allocating resources, both technical and financial-
parliamentary cluster ASSESSING THE QUALITY
OF HEALTH SERVICES
• QUALITY ASSURANCE UNIT – MOH/COHSASA
• SECTOR WIDE APPROACH- Partners, suppliers,
CHAL, NGO’s
• SLMTA run by ACILT

18. COHSASA - Improving health care through standards & accreditation
The Council for Health Service
Accreditation of Southern Africa
(COHSASA)

19. Facilities and Safety - Module 2 19
Organization
Personnel
Licensed/certified
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process Improvement
Customer Service
Facilities
&
Safety
The Quality Management System

20. Personnel
Performing specific Medical Laboratory tasks
Qualified Professional
Education
CBE Training
Professional
Experience
+
Demonstrated
Skills + Passed
Board Exam
MLS Regulatory Board License

21. Measurement of Quality health care
• Measurement Compliance with the above expectations
has been assessed by:
• questionnaires and medical examinations before and
during employment;
• staff satisfaction surveys;
• exit interviews when staff resign;
• routine indicators of sickness, absence and turnover;
• safety audits, such as handling of glutaraldehyde and
cytotoxic chemicals;
• quality circles;
• statutory inspectorates;
• external certification of personnel management
function.

22. Legislation within the workplace
LAW RIGHT
Employment Equity
Act (EEA)
a) Right not to be unfairly
discriminated against on the
basis of your HIV status
b) Right not to be tested for HIV
unless your employer ahs applied
to the Labour Court for
authorisation
c) Do not have to disclose HIV
status
Occupational
Health and Safety
Act
Right to a safe working environment

23. Accreditation of Southern Africa
(COHSASA)
The Council for Health Service is the only
internationally accredited quality
improvement and accreditation body for
healthcare facilities based in Africa. In the
past 20 years over 600 facilities
throughout the continent have entered the
COHSASA programme to improve the
quality and safety of the healthcare
services they provide to patients.

24. COHSASA
• Think Tank Trainings and motivation-
proposalscohsasa_hospital_standards_-
_certificate.pdf

25. LFL
• To encourage one-to-one interaction of all testing, calibration and inspection
laboratories in order to guide in workplace Laboratory capability, development of
skills , infrastructure and assessment necessary for accreditation
• To represent the experience, knowledge and formulated opinions of all Lesotho
laboratories on a technical, ethical and commercial level .
• To assist in the interpretation of accreditation requirements, to identify generic
national accreditation needs and to resolve issues on such matters for all
Laboratories in Lesotho
• To establish a singular interface of representation of its members with SADCAS and
ILAC.
• To establish effective communication channels for technology transfer with
organizations that have similar objectives to the NLA-L
• To provide and encourage International professional recognition for scientific work
and provide appropriate training in Quality management systems and all issues of
accreditation.
• Liaise with SADCAS and other International Organizations, for all government
Laboratories and private laboratory facilities in matters related to accreditation,
capacity building and on going personnel certification.

26. accreditation services for SADC Member States aimed at:
• Supporting regional and international trade;
• Enhance the protection of consumers and the
environment; and Improve the competitiveness of SADC
products and services in both the voluntary and
regulatory areas.
• SADCAS offers programmes for the accreditation of
testing/calibration laboratories, certification bodies
(management systems/product/personnel) and
inspection bodies

27. Structures of support• ISO
• International Accreditation Forum (IAF) and International Laboratory
Accreditation Cooperation (ILAC)
• AMCOA- , ASLM, AMLSA, AMLSCSA
• SADCAS is recognized by the SADC Council of Ministers as a subsidiarity
organization of SADC.
• to raise awareness of the importance of accreditation‐related activities IN
Lesotho
• make sure structures will be in place for Lesotho and other SADC
COUNTRIES to establish its own capacity state of art conformity
assessment body like Mauritas and SANAS
• ..ISO 15189 STANDART.doc- SADCAS ASSESSORS TRAININGS
• Review of new public health bill
• MLS -Regulatory board
• Lab policy , quality manual initiation and biosafety manaul
• ACILT
• SLMTA
• Readiness of laboratories to apply for SADCAS certificate= -
• Advocacy, awareness, Assessments and mentorship activities

28. REGIONAL SUPPORT
• SADC Member States aimed at:
• Supporting regional and international trade;
• Enhance the protection of consumers and the
environment; and
• Improve the competitiveness of SADC
products and services in both the voluntary
and regulatory areas.

29. The SADCAS MLAP
The SADCAS Medical Laboratories Accreditation
Programme (MLAP)
– Established in June 2010
– A multi-disciplinary accreditation program
operated in accordance with ISO/IEC 17011
– The fields of accreditation under the SADCAS
MLAP include: Biochemistry; Cytology;
Hematology; Histopathology; Immunology;
Microbiology; Pathology; Virology; Serology;
Andrology
29

30. ISO 15189 Technical Assessors- SADC-EU.
Botswana ; LESOTHO CANDIDATES 2010-
12

31. Technical systems, and process control

32. The SADCAS MLAP – Accreditations by Country
32

33. Levels of care needing quality
View larger version:
Figure 3

34. The SADCAS MLAP - Applications
by Scope
34

35. Improve Systems and programs – to address MDG’s ,
PRD’s,
• International health
Regulation ,
regulators, policies,
laws, Biosafety and
biosecurity
• political science .
• Economics,
Acriculture
• trade stds,
accreditation, basic
living, income
diversification,
lifestyles,
• Environment
• Biodiversity ,
Biotechnology,
• Industry ,
hydrogeology, town
planning
• Community
• Culture ,
education,
sociology
Medical and nursing
Laboratory
medicine
Health planning, HR,
Administration
Pharmacy,
physiotherapy
Information mgt ( I C T)

36. YES WE CAN!!!!!

41. Our voices should be heard !!!!!!!!
after this Gap analysis

42. International Networking events and
Collaborations- BENCHMARKING

43. Needs for applications
• Application for Good Clinical Practice (GCP) Compliance
Status
• Application for Good Laboratory Practice (GLP)
Compliance Status
• Application for Inspection Body Accreditation to ISO/IEC
• Application for Medical Laboratory Accreditation to ISO
15189:2012
• Application for Proficiency Scheme Provider
Accreditation to ISO/IEC 17043F
• Application for Reference Material Producer
Accreditation to ISO Guide 34F
• Application for Testing and Calibration Laboratory
Accreditation to ISO/IEC 17025

44. Way Forward and Call to Action
• Excellent medical laboratories AND OTHER
CLINICAL SERVICES are vital to ensure accurate
diagnoses and to identify pathology at early
disease stages.
• It is essential to embark on solid operational
research to identify the root causes of poor
laboratory service AND OTHER CLINICAL
SERVICES to develop practical models for not
only building, but also maintaining medical
laboratory capacity and services in developing
countries.

45. Recom
• Government officials and health care professionals
in these countries should agree on the importance
of creating strong medical diagnostic capabilities.
• The need for quality laboratories is often not
considered a priority in improving a struggling
health care system.
• A significant investment should be made in
laboratory systems and financial accountability to
ensure universal access to efficient, accurate
laboratory testing.

46. Laboratories Quality Systems
Laboratory quality systems are critical to the
success of any laboratory service.
The most important prerequisite for the
establishment of an effective laboratory quality
system is to create and/or adopt medical
laboratory standards and regulations specific for
each country’s unique setting. Currently, some,
follow international laboratory standards such as
the International Organization for
Standardization (ISO 15189), Good Clinical
Laboratory Practices (GCLP),

47. • A focus on strengthening laboratories could
change largely empiric algorithm-based
clinical care to rapidly confirmed diagnoses
with targeted curative treatment and cost
savings.
• . Building and maintaining a strong,
sustainable medical laboratory infrastructure
in RLS will help build and strengthen the
whole medical system by ensuring sufficient
diagnostic capacity to produce accurate and
reliable laboratory results that improve
patient outcomes

48. • “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 1997

49. 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. ?

50. • Thank you