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

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

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.

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

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.

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

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

Proactive to Prevent

Paparatzi after a Medical Lab Scandal ?

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???

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).

• 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

Pro-active Quality Health management

delivery system

Patient Sales and marketing

Accreditation

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

Medical staff

Health systems and programs

MDG’s

Community involvement

Competent motivated Health

professionals

Quality

Patients programs

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

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.

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

• MLS- BOARD

COHSASA - Improving health care through standards & accreditation

The Council for Health Service

Accreditation of Southern Africa

(COHSASA)

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

Personnel Performing specific Medical Laboratory tasks

Qualified Professional

Education CBE Training

Professional Experience +

Demonstrated

Skills + Passed

Board Exam

MLS Regulatory Board License

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.

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

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.

COHSASA

• Think Tank Trainings and motivation- proposals\cohsasa_hospital_standards_-_certificate.pdf

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.

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

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

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.

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

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

Technical systems, and process control

The SADCAS MLAP – Accreditations by Country

32

Levels of care needing quality

View larger version:

Figure 3

The SADCAS MLAP - Applications by Scope

34

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)

YES WE CAN!!!!!

Our voices should be heard !!!!!!!!

after this Gap analysis

International Networking events and

Collaborations- BENCHMARKING

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

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.

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.

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),

• 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

• “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

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. ?

• Thank you