Progress Toward Quality Management Systems Implementation and Laboratory Accreditation in the Caribbean region

Transcription

1 Progress Toward Quality Management Systems Implementation and Laboratory Accreditation in the Caribbean region George Alemnji, Ph.D. Laboratory Advisor, Global AIDS Program CDC Caribbean Regional Office 1

2 The Caribbean Region

3 Introduction A Third World Region with Third World Problems

4 Better positioned than their African counterparts However, health systems strengthening is still an issue Implementation of Laboratory QMS and Accreditation is still a challenge

5 Introduction Continue Over laboratories accredited worldwide Less than 0.05% (16) are located in the Caribbean region Only six (6) of them are medical laboratories Only one (1) is public (government) > 90% of the people use the public hospitals (government subsidy)

6 Past Efforts Toward QMS Improvement in the Caribbean

7 The EU Funded Project In response to evidence of unacceptable high levels of laboratory errors Absence of regulation and legislation in most of the Project countries Result: 1% failure Very few Caribbean laboratories were accredited.

8 The EU Funded Project Funded by the European Union Implemented by the CAREC Nov 2002 to Dec 2007

9 Laboratory Challenges in 2003 Shortages of staff, equipment & supplies Weak lab management & operational systems WARNING OUT OF ORDER DO NOT USE Limited government commitment Absence of national or regional standards 9

10 Laboratory Challenges in 2003 Planning > 21% countries had no strategic health plan Regulations > 68% countries had no regulations for labs Laboratory Management > 71% had no staff training programme Quality Management 75% had no assigned responsibility for quality mgt. Safety 92% had no safety programme

11 Project Strategies Focus on governance mechanism Creating alliances with key stakeholders Utilizing an inclusive and participative approach to decision-making Encouraging ownership of the change process 11

12 Achievements ISO adopted as regional standard Guidance Document developed Model legislation for med labs established Regional MLT curriculum developed Lab staff trained in quality management and ISO

13 Process/Policy Improvements

14 Outcome Project ended in 2007 Despite all these, progress toward QMS implementation and accreditation in the entire region is still very slow Main Reasons: Cumbersomeness of the process Lack of advocacy at all levels 14

15 Way Forward The region should adopt The Step-wise Approach End Point CAP ISO JCI SADCAS SANAS --Etc Incremental process

16 1) Ladymeade Lab Accredited By CAP

17 How it all Happened Buy-in from the Barbados MOH Lab management team implemented the ISO QMS including issues of Biosafety

18 Key to this Success Strong support from the Barbados MOH Solid lab management (designated QO) Ministry of Health Motivated lab staff Both Regional and Headquarter CDC and other partners' support

19 2) CDC/WHO/PAHO/CHAI Initiative Meeting on Implementation of the CDC/WHO-AFRO/PAHO Step-Wise Process to Prepare Laboratories for Accreditation in the Caribbean Region Kapok Hotel Cotton Hill, St. Clair Port of Spain, Trinidad and Tobago March 29-30,

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21 Attendance WHO/PAHO, CAREC, CARICOM, PANCAP, CDC Atlanta, CDC Central America, CDC Dominican Republic, CDC Barbados, DoD CHAI (Laboratory and Latin America & Caribbean team) CMLF JANAAC TTLABS MOH, Haiti

22 Expected Outcomes of this Meeting To learn about the CDC/WHO-AFRO/PAHO tools To assess its applicability in the Caribbean region To agree on best way forward to implement Quality Management Systems and Laboratory Accreditation in the Caribbean region

23 Summary Outcome There is high level of awareness of the ISO QMS in the region More advocacy at all levels is needed in the region A cost benefit analysis showing advantages and disadvantages of lab accreditation should be done

24 Summary Outcomes The region should develop its own step wise graded process. The current WHO AFRO checklist should serve as a skeleton The SLMTA and the Structure Mentoring program should be encouraged The region should develop southsouth/third-world third-world partnerships

25 Conclusion and Way Forward In line with the WHO Lyon meeting in April 2008, PAHO/WHO with the participation of other partners, including the United States CDC and CHAI, will provide guidance to develop a joint strategy to implement a stepwise approach to sustainable quality management systems and facilitate the process of accreditation of laboratories in the Caribbean region. The particular contours of a stepwise approach best suited to the Caribbean region will be determined through the evaluation of existing programs and further consultations. PAHO/WHO and partners will advocate at all levels for a stepwise approach to strengthening, evaluating and recognizing progress in the improvement of laboratory quality management systems toward accreditation

26 3) Second Meeting PAHO-CDC Joint Meeting on Developing a Strategic Framework Document for Implementation of Quality Management Systems in a Step-Wise Approach Toward Accreditation of Laboratories in the Caribbean Region Kapok Hotel Cotton Hill, St. Clair Port of Spain, Trinidad and Tobago August th 2010

27 Background The WHO and CDC joint Conference on Laboratory Quality Systems in Lyon, France in April 2008 The WHO-AFRO Step-Wise Laboratory Accreditation Scheme Launched in Rwanda, July 2009 Thailand S Step-Wise Laboratory Accreditation Process The Argentina Step-Wise Laboratory Accreditation The EU Funded Project on QMS Improvement in the Caribbean region

28 Specific Objectives Encourage and aid national governments to develop and implement registration/ licensing of all medical laboratories Implement stepwise recognition of quality improvement and implementation of quality management systems and accreditation Provide a pathway for medical laboratories to progressively fulfill the requirements of ISO 15189

29 Main Outcome Implement a stepwise assessment and recognition process for medical laboratories to strengthen quality management systems and prepare laboratories in the Caribbean region for accreditation.

30 Next Steps September 1 st 2010 draft report submitted September 10 th 2010 workgroups begin discussions December 2010 submit final report June 2011 Launching

31 Opportunities in the Region Presence of some national accrediting bodies such as JANAAC, TTLABS Presence of CAREC, CLAS/CROSQ and CMLF Presence of some MOH lab management staff and private individuals (directors, managers, QA coordinators etc) with QMS vision

32 CDC Offices Involved GAP CDC Caribbean Regional Office, Barbados GAP CDC Central American Office, Guatemala GAP CDC Guyana Office, Guyana GAP CDC Dominican Republic Office, Dominica GAP CDC Haiti Office, Haiti

33 PEPFAR PEPFAR: President s Emergency Plan For AIDS Relief PEPFAR II vision is on overall health systems strengthening with eventual transfer of ownership to the countries and regions Lab emphasis is on: Capacity building, equipment and infrastructure upgrade, QMS, accreditation Ensure staff retention and long-term sustainable lab services and systems

34 PEPFAR Laboratory Indicators Number of testing facilities (laboratories) with capacity to perform clinical laboratory tests Number of testing facilities (laboratories) that are accredited according to regional or international standards Number of people who receive laboratory tests for diagnosis and clinical monitoring Number of individuals trained in the provision of laboratory related services

35 PEPFAR Laboratory Strengthening Support countries to develop National Laboratory Strategic plans Implement LIS Implement EQA (PT) Procurement/Service contracts Support countries to sustain HIV diagnostic services (serology, DNA PCR) Bio-safety Trainings Support countries to sustain clinical laboratory monitoring platforms (CD4, Haem, Chem, viral load, TB, HIV drug resistance, OIs). Implement QMS Accreditation

36 Caribbean Regional Lab Referral and Back-up System Jamaica Bahamas Trinidad & Tobago HUBS Belize Suriname Regional Ref Laboratory Barbados OECS Countries

37 Expected OECS Support from Barbados DNA PCR Viral Load HIV Drug Resistance QA/QC Training Other emerging complex diseases (E.G H1N1 etc)

38 Acknowledgement -John Nkengasong -Shirley Lecher -Bharat Parehk -David Crosss -Katy Yao -Shanna Nesby Sandra Juarez Ann Malla Gayathri Warnasuriya -Guy-Michel -Gershey-Damet -Phil Rotz -EU Project team CHART-CCAS-CDC -Giselle Guavara -Ladymaede team 38