Overview of medical laboratory regulatory council, objectives 2013

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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 …

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

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  • 1. overview of Medical Laboratory RegulatoryCouncil, Objectives , progress report, workshopexpectations 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 Personeltraining 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 CARENETWORKS -establishment of uniform standards of health care and health care servicedelivery, including specific objectives and targets for the Ministry for Health, districthealth councils and categories of public, private, non-governmental and charitablehealth care establishments, management and personnel, to ensure delivery of healthcare 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 forHealth and its SWAp partners as specified in section 45(1) to harmonise funding forhealth services from the annual and supplementary health appropriations in theConsolidated Fund or other public money and from the Government’s developmentpartners, including but not limited to international donors, non-governmental andnon-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 Councilsetc. , 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 bodiesCertification Inspection Test CalBody 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 TrainingEducation Experience Skills + Passed Professional Different Board Exams MLS Regulatory Board License + Professional Qualifications/ Credentials
  • 17. Specific personnel to perform: Sampling Tests / calibrationsKeep records Include dates Issue test reports/calibrations certificatesReadily 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 01-10-2012Time Topic / Activity By Whom08:00-08: 30 Registration08:-30-08:45 Official opening DLS08:45-09:00 Introduction , Objectives of the workshop and expectations Sejojo Phaaroe09:00-09:45 The role of a Professional Association09:45-10:15 The Role of a Professional Council Sejojo Phaaroe10:15- 10:45 Discussions10:45-11:15 TEA11:15-12: 45 Critical review of Health Professions Bill Zero Draft All12:45-14:00 LUNCH14:00-15:00 Critical review of Health Professions Bill Zero Daft All15:00-16:15 Correlation , Extraction of Minimum standards and Discussions Sejojo Phaaroe16:15- 16: 30 TEA16:30 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 02-10-2012Time Topic / Activity By Whom08:00-08: 30 Registration08:-30-08:45 Group Repertoire Groups08:45-09:00 Overview of a Medical Laboratory Policy and strategy Ms Tsietso Motsoane09:00-09:45 Review of Medical Laboratory Council , structures and function Sejojo Phaaroe09:45-10:15 Discussions and extraction of Minimum Standards All10:15- 10:45 Review of Medical Laboratory Rules and Regulations Sejojo Phaaroe10:45-11:15 TEA11:15-12: 45 Discussions and extraction of Minimum Standards groups12:45-14:00 LUNCH14:00-15:00 Review and comparison of ISO Standards Groups15:00-16:00 Group Repertoires16:00 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 3Time Topic / Activity By Whom08:00-08: 30 Registration08:-30-08:45 Group Repertoire08:45-09:00 Management and Managing aspects of a health system Sejojo Phaaroe09:00-09:45 Communication channels in public services HR09:45-10:15 Discussions All10:15- 10:45 Recruitment and selection process in public services HR10:45-11:15 TEA BREAK11:15-12: 45 code of conduct 2008 , and Employment benefits in public services HR Discussions HR12:45-14:00 LUNCH14:00-15:00 Presentation of Minimum standards extracts Sejojo Phaaroe15:00 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