Montego Bay, Jamaica 24 th August, Presented by: Omah Maraj Desiree Herrera
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1 Montego Bay, Jamaica 24 th August, 2011 Presented by: Omah Maraj Desiree Herrera
2 Introduction In preparation for the creation of the entity CARPHA (Caribbean Public Health Agency), the Caribbean Epidemiology Centre (CAREC) aligned its work plan with that of PAHO.
3 Introduction CAREC now focused on its core Public Health functions and ceased clinical diagnostic services in October As a result of this restructuring, there was a transfer of diagnostic/clinical assays to countries which would simultaneously build country capacity.
4 Introduction In Trinidad and Tobago: Transfer to 2 main Institutions: o The Trinidad Public Health Laboratory (TPHL) o Eric Williams Medical Sciences Complex (EWMSC), a hospital of the NCRHA.
5 EWMSC was identified as the best possible site for the transfer of Introduction Molecular Diagnostic Services (HIV Viral Load and DNA PCR) Laboratory support for Organ Transplant (Transplant Immunology)
6 Introduction January 20 th -23 rd 2009: Clinton Foundation team visited the EWMSC Lab on two occasions and met with relevant stakeholders to discuss details of establishing the Molecular HIV Lab.
7 Introduction Key stakeholders: Ministry of Health Trinidad and Tobago (MOHTT- HACU) Clinton Health Access Initiative (CHAI) National AIDS Coordinating Committee (NACC) NCRHA (Finance, Legal, CEO, Tenders, Evaluation, Board, Laboratory, Complex manager)
8 Introduction On request from the MOHTT, the Clinton Foundation arranged for Dr. Duncan Blair, a Laboratory specialist, to visit and assess this site. A report was submitted which outlined key recommendations.
9 Introduction Based on these recommendations the NCRHA, MOHTT and CAREC worked towards implementing the Molecular HIV diagnostic service The Molecular HIV Laboratory team worked towards implementing essential elements of a QMS
10 Introduction On 19 th July 2010, the Eric Williams Medical Sciences Complex (EWMSC) Diagnostic Laboratory officially launched Molecular HIV Diagnostic Testing.
11 ELEMENTS OF A QMS Organization Personnel Equipment Facilities & Safety Specimen Collection & Testing QC /QA & EQAS Data Inventory Record Keeping Monitoring System Improvement Client Satisfaction
12 Organization
13 Organization The Molecular HIV Diagnostic service functions as a National Service which was initiated with funding from the World Bank.
14 Organization The present organogram at EWMSC Diagnostic Lab, needs to be modified to fully accommodate the new National Services The HIV/AIDS Coordinating Unit of the MOH provides oversight of the program and monitors service provision
15 Personnel
16 Personnel Recommendations by Dr. Blair: 2 Junior Technicians 1 Senior Technician Hiring of replacement staff Hiring of a full time Quality manager
17 Personnel Reality: 4 technicians from 3 different departments initially selected for training. No Quality Manager hired. No additional technicians hired. A qualified Laboratory Consultant hired.
18 Personnel Result: Major staffing adjustments needed Increased workload for selected technicians Staff shortages at times from other departments
19 Personnel Dynamics of TEAM building Forming Storming Norming BUT consistently PERFORMING
20 Personnel Three additional technicians were selected for training in 2011 The competency of these Technicians was assessed using checklists that were developed for each procedure indentified in the Molecular HIV workflow charts.
21 Personnel One technician resigned Further adjustments needed At present there are 6 technicians from 4 different departments
22 Equipment
23 Equipment Proposals were invited from vendors providing commercial assays for HIV-1 viral load testing, certified for in vitro diagnostics. Roche Molecular Diagnostics was awarded the contract through Bryden Pi Ltd.
24 Equipment The HIV Molecular testing instrument and analyser were provided by ROCHE: COBAS AmpliPrep instrument with the COBAS TaqMan 48 analyser
25 Equipment COBAS AmpliPrep Instrument
26 Equipment COBAS TaqMan 48 Analyzer
27 Equipment COBAS AmpliLink Software + Data Station
28 Equipment Ancillary equipment : Biosafety Cabinet (BSC) Special centrifuges Dedicated Refrigerators Freezers.
29 Equipment Biological Safety Cabinet (BSC)
30 Facilities and Safety
31 Facilities & Safety The Molecular Lab is a limited access area. The 2 rooms are situated in a high public traffic area Danger of patients being exposed to contaminated material
32 Facilities & Safety In a Molecular Biology Lab workflow must be unidirectional THE SENSITIVITY OF THE PCR PROCESS MEANS THAT CONTAMINATION AT ANY STEP WILL LEAD TO FALSE POSITIVES.
33 Facilities & Safety Although the instrument and analyser are closed systems, every effort has been made to ensure that strict safety guidelines and adherence to Molecular workflow requirements are maintained.
34 Facilities & Safety Although the layout of the lab is not ideal, every effort was made to adhere to the structure of a molecular lab. 3 rooms at the EWMSC lab were selected, assessed and determined to provide sufficient and appropriate space. With minor renovations the rooms were made suitable for delivery of a quality service.
35 Pre Refurbishment PCR 1 PCR 2 PRE ANALYTICAL & SET UP AREA DESIGNATED FOR LOCATION OF TAQMAN & AMPLIPREP
36 Renovations Refurbishment work in progress Post installation of A/C & Extractor Fans
37 Post Refurbishment PCR 1 PCR 2 PRE ANALYTICAL & SET UP AREA LOCATION OF TAQMAN & AMPLIPREP
38 Specimen Collection and Testing
39 Sample Collection & Testing Sample collected from Specimen reception Process workflow for HIV-1 viral load testing Sample type: Plasma Sample type: EDTA whole blood Centrifuge at 2200rpm, rtp Sample acceptable, But data incomplete Sample acceptable i.e. sufficient volume, not haemolysed Sample unacceptable Follow-up of incomplete data Accepted as STAT Sample rejected and client informed Patient data entered on LABIS (electronic data base) Sample forwarded to HIV Molecular Diagnostics Lab Aliquots stored at -80 C Carry out COBAS Ampliprep/Taqman test Yes Is result in linear range? No Results reported Test repeated using dilutions if necessary
40 Procedures and Policies Policies and Standard Operating Procedures (SOPs) for each step of the workflow process were prepared and are followed. Rejection criteria were developed. In order to ensure that quality service is provided it is necessary to strictly adhere to these policies and procedures.
41 QA/QC and EQAS
42 QC/QA and EQAS The AmpliPrep instrument was validated against the Amplicor at CAREC. It is important to note however that the reference range for the Amplicor is < 400 to cp/ml & the reference range for the AmpliPrep is < cp/ml A validation against the same platform or a validated platform with a similar range is pending
43 QC/QA and EQAS Quality Control samples are tested with every run Kit controls Internal Quality Control (IQC) / Process control
44 QC/QA and EQAS IQC samples are prepared from pooled plasma which is tested, aliquoted and stored. DBS IQC are made from known EDTA whole blood samples.
45 QC/QA and EQAS Levy-Jennings graphs generated Positive Kit controls IQC
46 External Quality Assurance Services (EQAS) EQAS
47 DATA
48 Data A comprehensive system of data collection and storage was developed. Logs are kept for specimen receival, sample rejection, temperature charts, results etc. Equipment logs are also kept user, date, time etc.
49 Data All data is stored in an easily retrievable manner in labelled binders and folders. It is hoped that in the near future we will be able to combine the data from our CD4 counts and VL tests to track patients over a period of time and so supply more comprehensive report to physicians
50 Inventory
51 Inventory All stock reagents and consumables are accounted for in individual inventory logs. Inventory is updated as items are used.
52 Record Keeping
53 Record Keeping A n Excel spreadsheet is used for record keeping. Hard copies provide back-up. Records of technician training and competencies are also kept in individual Personnel folders.
54 Monitoring
55 Monitoring The HIV Molecular Lab is managed by a Lab Consultant. The team has documented weekly meetings.
56 Monitoring An Internal audit has been performed which identified gaps. Corrective action to follow. Process control IQC Monitors the entire testing process
57 System Improvement
58 System Improvement A Systems Improvement Log is used to document all errors and corrective action taken. These logs provide a means of viewing how errors increase or decrease over time and serve as a good quality indicator.
59 Client Satisfaction
60 Client Satisfaction Dr. Armour of the HACU MOHTT notified clients of the transfer of services to EWMSC We presently provide service to: SFGH HIV Clinic SGH ERHA TRH and THPC Cyril Ross Nursery POPC EWMSC Any in-house requests
61 Client Satisfaction The stated Turnaround time (TAT) for VL/DNA PCR is 14 days but has been as little as 3-4 days. Increased TAT has been due to equipment down time. Challenges Backlog
62 Client Satisfaction The issues faced include: Broken AmlpiPrep covers Reagent open - expiry date (internal quality mechanism in machine) Circuit board failure
63 Client Satisfaction Client satisfaction is of the highest priority for this Molecular HIV team. Presently there is no formal mechanism for assessing client satisfaction and this will be addressed.
64 The Future For Molecular HIV At EWMSC Our GOAL at the Molecular HIV Diagnostic Lab of the EWMSC is to FULLY implement and operate under ALL elements of a Quality Management System.
65 The Future For Molecular HIV At EWMSC When the implementation of QMS is complete, the next step would be ACCREDITATION as a medical diagnostic laboratory in compliance with ISO 15189:2007.
66 The Personal Impact On Molecular HIV Team Nicolette James Working in the molecular Department has made me even more committed to proper patient care and helped me develop my skills as a Medical Lab Technician.
67 The Personal Impact On Molecular HIV Team Ronnie Jhingai Being part of this Molecular HIV Team has enhanced my skills as a Medical Lab Technologist & has presented me with the knowledge to be able to think like a Manager
68 The Personal Impact On Molecular HIV Team Omah Maraj This experience has taught me that quality is never an accident. It is the result of planning, teamwork and a commitment to excellence.
69 The Personal Impact On Molecular HIV Team Kimberly Rahamut This opportunity has indeed developed my skills technically, enhanced my decision making & it s an honor to provide continued quality health care for a national service
70 The Personal Impact On Molecular HIV Team Desiree Herrera To think and operate with quality foremost in view. To think in terms of offering service - not just a job but a profession that serves.
71 The Personal Impact On Molecular HIV Team Naila McLeod-Goodridge The patients come to mind first. Without even realizing it we are impacting positively on the lives of PLWHA, & this thought helps me appreciate the opportunity to work with this team.
72 Acknowledgements Management of EWMSC Diagnostic Laboratory o Dr. Ayanna Baptiste Clinical Director o Mrs. Udra Sookal-Goolsair Laboratory Manager (Ag.) o Mr. Lewis McIntosh Business Manager Mrs. Anjenny Dwarika Lab Manager (former) Ms. Deana Sammy Business Manager (former) Dr. Laura Lee Boodram CAREC Consultant Dr. Brian Armour Programme Director, HACU MOHTT Dr. Ayanna Sebro Treatment & Care Coordinator, HACU MOHTT The ROCHE Technical and Management team
73 Acknowledgements Special Acknowledgement without the hard work and commitment of one person this rolling out would NOT have been possible. She has been not only the driving force behind this project but the steering wheel and gear shift as well. For success in any major project, it is vital to have a focal point person with the authority to make things happen.
74 Acknowledgements We were privileged to have this in the person of Ms. Arlene Darmanie - Laboratory Consultant Mentor Coach Teacher
75
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