APIN LABORATORY SERVICES
The Laboratory Services Department of APIN supports and manages the provision of state-of-the-art laboratory services for HIV and TB treatment at all tiers of healthcare facilities in Nigeria. The department engages in active collaboration with hospitals, universities and research institutions, as well as Federal and State Ministries of Health, Faith Based Organisations (FBOs) to strengthen laboratory systems in public, private and missionary hospitals. The laboratory program of APIN is an offshoot of the Harvard School of Public Health PEPFAR project. The department has a reputation for the provision of quality service delivery with over 12 years of experience in designing, developing and managing both routine and hi-tech laboratories supporting ART, TB and other disease of public health in Nigeria. Through funding from PEPFAR and Global Fund, APIN is currently supporting the provision of comprehensive laboratory services at more than 60 healthcare and research facilities in three assigned lead states of the country. Out of these laboratories are 6 Molecular Diagnostics (PCR), 3 HIV Drug Resistant (HIV-DR), and 2 TB Multi-Drug Resistant (MDR-TB) testing laboratories. Before the PEPFAR Nigeria rationalization policy by USG, APIN had previously managed 48 comprehensive facility laboratories including 10 PCR laboratories, some of were transitioned to other implementing partners.
The department has well experienced and highly skilled program staff that are responsible for the implementation of its services in active collaboration with partner institutions. The department also has a pool of highly-skilled and well-experienced laboratory professionals derived from supported institutions.
The laboratory department is organized into 6 operational units headed by an Associate Director, and supported by the supervisors for each of the units.
- Core HIV Laboratory,
- TB/HIV Laboratory,
- Molecular Diagnostics,
- Quality Assurance,
- Capacity Building,
- Commodity Logistics, and
- Field services.
Program management activities of the department are coordinated from the central office located in Abuja, while field activities are coordinated from state offices located in Lagos, Oyo, and Plateau.
“To become the foremost provider of quality clinical and research laboratory support in Nigeria, with a reputation for service excellence driven by innovation and professionalism.”
“To improve and expand the provision of laboratory diagnostic and monitoring services that will support the effective implementation of prevention, care, and treatment programs in public health and clinical settings.”
Objectives of the Laboratory Program:
- Provide a cost effective, appropriate, and high quality laboratory services at all levels of healthcare.
- Strengthen and expand laboratory services and infrastructural development for efficient service delivery.
- Strengthen laboratory supply chain management system, and provide effective equipment maintenance support.
- Strengthen quality management capacity of supported facility laboratories towards national and international accreditation.
- Develop a pool of highly skilled laboratory professionals through intensive trainings and capacity building activities.
- Collaborate with and support relevant agencies of GON and USG PEPFAR, and other stakeholders in developing appropriate national tools to aid service delivery.
- Keep our staff motivated and well equipped to discharge their responsibilities in a conducive environment.
SCOPE OF SERVICES AND COMPONENTS OF LABORATORY SUPPORT
Laboratory Design and Infrastructural Upgrade
Over the years, the department has been actively engaged in the design and development of laboratory infrastructure to support clinical and public health services at the supported facilities. Facility laboratories are supported and provided with the appropriate infrastructure and enabling environment necessary to support quality testing services. Baseline/needs assessments are conducted for selected facility laboratories to identify need for infrastructural renovation and/or upgrade. This is vital in ensuring that laboratory layout, floor plan, workstations are adequate enough and well-organized to facilitate optimal workflow and ensure safety. Appropriate utilities such as alternative power and water supply are also provided to support service provision.
Laboratory Testing Services
Laboratory services at all the comprehensive treatment facilities are supported with the capability to perform full range of tests ranging from screening, diagnostic, treatment and monitoring tests for HIV/TB using manual, semi-automated, and fully automated and hi-tech diagnostic systems. The support covers the provision of appropriate equipment and supplies, including automated analytical equipment for CD4 T-lymphocyte enumeration, blood chemistries, haematology, and molecular diagnostics. Non-analytical supporting equipment are also provided such as centrifuges, biosafety cabinets, autoclaves, blood mixers, micro-pipettes, refrigerators, incubators/water baths, water distillers, etc. Laboratory services at selected Primary level facilities are supported with point of care testing devices such for CD4 T-lymphocyte enumeration, and Haemoglobin and/or Haematocrit estimation
|1||Serology||HIV, HBsAg, HCV, VDRL, hCG rapid testing and ELISA techniques.||ELISA washers and Readers|
CD4 and CD4% T-lymphocyte
|Partec Cyflow, BD FACSCount, and Alere PIMA for point of care testing.|
|3||Chemistry||Liver function tests, Renal function tests, Lipid profile, Blood electrolytes, Blood glucose, Amylase, etc.||COBAS C-111 and 311 series, Roche Reflotron for point of care testing.|
|4||Hematology||Full blood count (FBC), WBC differentials, Hemoglobin/Hematocrit, Blood morphology||Mindray BC-3200 and 5200 series|
|5||HIV Molecular Diagnostics||HIV-1 RNA-PCR, HIV-1 DNA-PCR assays||COBAS Taqman and COBAS Ampliprep|
|6||Gene Sequencing||HIV drug resistance testing||Applied Biosystems|
|7||TB Services||TB Microscopy, TB-DNA PCR, TB Multi-drug resistance||GeneXpert, Hains Assay, Fluorescence microscopes|
Training and Capacity Development
APIN is a key player in the development of laboratory training programs and delivery of laboratory and related trainings. The laboratory department recognizes laboratory personnel as a great asset, and sees their professional development as key to the provision of quality services. Trainings are planned, organized and conducted to meet the training needs of all cadres of laboratory and other healthcare professionals at all the supported facilities, as well as staff of other partner institutions, Federal and State Ministries of Health (FMOH/SMOH). Our flagship yearly laboratory quality conference has trained more than two hundred and fifty personnel vast in quality management system, laboratory safety and other key topics. Since inception, the APIN laboratory program has trained more than one thousand healthcare professionals on laboratory and related topics.
Trainings are periodically organized and covers a wide range of areas including the following:
- Activation trainings,
- Basic HIV diagnosis (HIV serology),
- Molecular HIV diagnosis (DNA, RNA PCR, and Gene Sequencing),
- Basic TB diagnosis (AFB Microscopy),
- Molecular TB diagnosis (GeneXpert, Hains Assay)
- Sample Collection and Handling,
- Quality Management System,
- Good Laboratory Practice,
- Quality Control and LJ-Chart,
- Equipment maintenance,
- Logistics and Inventory Management,
- Quality Audit and Accreditation,
- Laboratory safety and waste management,
- SLMTA, etc.
The department also collaborate with other departments to train other healthcare professionals. There are existing collaborations with PMTCT team, Prevention team, Clinical team, etc to support trainings such as EID-DBS sample collection, HIV Counselling and Testing (HCT), Injection Safety, and Blood safety, etc.
Periodic on-site mentorship and supportive supervisory visits to the facility laboratories also provide great opportunities to identify capacity gaps and address them appropriately. Mentorship activities are targeted at the peculiar needs of each facility laboratory and individual laboratory personnel to improve their skills and capacity.
APIN “CLASS” Project
APIN is currently implementing a project titled “Capacitating Laboratories for Accreditation, Strengthening and Sustainability (C.L.A.S.S.)”
The project is designed to build the institutional capacity of Nigerian indigenous organizations implementing comprehensive clinical and laboratory services to sustain and enhance the prevention, care and treatment of HIV/AIDS. The project is funded by a grant from the President’s Emergency Plan for AIDS Relief (PEPFAR) with the specific purpose of building and strengthening the capacity of local and indigenous organizations in Nigeria to develop, implement, monitor and manage HIV/AIDS laboratory services and strategic information management activities that adhere to Nigerian national policy.
The main objectives of the project is to build and strengthen laboratory capacity by providing technical assistance that will ensure the following:
- strengthen laboratory management towards accreditation using the SLIPTA strategies,
- train and mentor assessors, and develop national assessment tools for laboratory audits in collaboration with Medical laboratory Science Council of Nigeria (MLSCN),
- enhance the provision of molecular diagnostic services,
- increase access to PCR services and linkages to the national HIV drug resistance surveillance network,
- enhance the effective implementation of advanced Tuberculosis (TB) diagnostic technologies in collaboration with the National Tuberculosis and Leprosy Control Program,
- improve efficiency of logistics management of laboratory commodities, etc.
This project is currently being implemented in collaboration with relevant agencies of Federal Ministry of Health and selected State Ministries of Health, as well as other PEPFAR Implementing Partners.
Procurement and Management of Laboratory Equipment and Supplies.
APIN supports the selection, procurement, distribution, installation and maintenance of automated and non-automated analytical and non-analytical laboratory equipment that support testing services. Service agreements are also established with appropriate vendors to ensure effective maintenance and optimal functioning of all supported equipment. A combination of an in-country vendor service and an active in-house equipment maintenance program using identified facility laboratory staff are employed to ensure an effective equipment maintenance system across supported laboratories.
The department also maintains an independent commodity management system with periodic quantifications, procurement, distribution and pipeline monitoring system for all the necessary reagents and supplies required to maintain uninterrupted laboratory services. APIN is the sole supplier of EID laboratory commodities (DBS collection bundles, HIV-1 DNA PCR reagents and consumables) for the national EID program in Nigeria.
Quality Management System and Accreditation
The laboratory program maintains a well-defined Quality Management Systems (QMS) infrastructure consistent with International Organization for Standardization (ISO) and Clinical Laboratory Standard Institute standards and guidelines. Our QMS and accreditation program implementation is structured according to ISO 15189 (2012) standard and CLSI GP-26A QMS Model for Laboratory Services. APIN supports the development, implementation, and monitoring of Quality Management System in all the supported health facility laboratories. The program also supports the processes for accreditation at selected facility laboratories. Generic QMS tools are developed centrally and distributed to facilities for them to customize and adopt.
APIN laboratory department is a key player in the implementation of the Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program established by WHO-AFRO regional office to serve as a framework for improving quality of public health laboratories in developing countries to achieve ISO 15189 standards. This program was rolled out in Nigeria in 2010 with 23 pilot laboratories out of which six are supported by APIN. Four out of the six laboratories being prepared for accreditation have been awarded 4-Star certificates of recognition by African Society for Laboratory Medicine (ASLM) on behalf of WHO-AFRO (in recognition of the level of quality improvement recorded). It is on record that two APIN-supported laboratories (NIMR TB Reference laboratory and NIMR Human Virology Laboratory) were the first laboratories to receive 4-Star SLIPTA certificate of recognition in Africa. APIN played several outstanding roles in supporting these laboratories to attain resounding success in the accreditation preparedness process.
Table 1: Laboratories Supported for Accreditation through the SLIPTA Program
|Facility||Baseline Score in 2010||Recognition Status (2013)||Remarks|
|NIMR (TB Reference Laboratory), Lagos||2-Star||4-Star
|Preparing for ISO 15189 Accreditation|
|NIMR (Human Virology Laboratory), Lagos||3-Star||4-Star||Preparing for ISO 15189 Accreditation|
|Jos University Teaching Hospital (JUTH), Jos||2-Star||4-Star||Preparing for ISO 15189 Accreditation|
|University College Hospital (UCH), Ibadan||1-Star
|4-Star||Preparing for ISO 15189 Accreditation|
|COCIN Hospital and Rehabilitation Centre, Mangu||2-Star
Table 2: Laboratories awaiting next round of ASLM Audit
|Facility||Baseline Score in 2010||Post-SLMTA Exit Score (2014)||Remarks|
|Lagos University Teaching Hospital (LUTH), Lagos||1-Star||3-Star||Awaiting next ASLM audit|
|Lagos State University Teaching Hospital (LAUTH), Lagos||2-Star
|Undergoing mentorship prior to next ASLM audit|
Our technical team are members of the Nigeria team for Strengthening Laboratory Management Towards Accreditation (SLMTA), a Master Trainer for the SLMTA program, and a Certified Auditor and Mentor for the SLIPTA program. These APIN team members provide support to the SLIPTA program both in Nigeria and Africa by facilitating SLMTA trainings, participating in SLIPTA audits, SLIPTA mentorship, etc. They also provide technical assistance to other partner institutions supporting laboratories for accreditation.
TB/HIV Laboratory Services
APIN supports the provision of routine and advanced laboratory diagnosis and follow-up for HIV patients with TB co-infection. Facility laboratories are supported with the capability to provide services for AFB microscopy, fluorescence microscopy (FM) for diagnosis, culture for follow-up, and Hain-Line probe assay for TB Multi-drug resistance monitoring. Supported facilities include the National TB Reference Laboratory at the Nigerian Institute of Medical Research (NIMR) Lagos, a Regional TB Reference Laboratory at the University College Hospital Ibadan. TB laboratory services are also supported at other DOT centres and all the comprehensive treatment facilities in collaboration with the National TB and Leprosy Control Program and other implementing partners such as Damien Foundation.
APIN has successfully and consistently provided technical assistance to all of its supported TB laboratories as well as the national and regional reference TB laboratories. These laboratories have also benefited from infrastructural renovations, laboratory capacity building through training of laboratory personnel, introduction of new detection technologies and provision of advanced equipment to enhance TB laboratory diagnosis. In collaboration with the NTBLCP, international consultants and national experts in the field of TB, APIN is involved in developing national policies, guidelines and checklists to ensure quality TB laboratory services.
LABORATORY CONTRIBUTION TO NATIONAL PROGRAM
Besides services provided for the APIN supported programs, the department also supports testing services for the national HIV and TB programs. Our staff also play major roles contributing to the development of the laboratory program at state and national levels.
- Six (6) supported laboratories at tertiary care hospitals and research institution have the capacity to perform early infant diagnosis (EID) by HIV DNA-PCR.
- Four (4) of these laboratories (LUTH, NIMR, JUTH and UCH) are linked to numerous PMTCT sites to provide DNA- PCR testing support for the national EID program.
- The six (6) PCR laboratories also provide viral load testing services for the APIN ART program, and have the capability of providing support to the national HIV program.
- APIN supports three out of the four drug resistant monitoring (DRM) laboratories in Nigeria. These laboratories are being prepared for WHO accreditation which will enhance their capacity to support both national and regional HIV-DR surveillance studies.
- APIN had previously managed 10 PCR laboratories six (6) of which were integrated into the National EID program before the USG rationalization policy on PEPFAR Nigeria program. Some of these laboratories were transitioned to other implementing partners.
Table 3: APIN Supported PCR Laboratories Providing Testing for the National EID Program
|NIMR Human Virology Laboratory||Yaba, Lagos State||COBAS Taqman/Ampliprep|
|Lagos University Teaching Hospital (LUTH)||Idi-Araba, Lagos State||COBAS Taqman/Ampliprep|
|Jos University Teaching Hospital (JUTH)||Jos, Plateau State||COBAS Taqman/Ampliprep|
|University College Hospital (UCH)||Ibadan, Oyo State||COBAS Taqman/Ampliprep|
|Other APIN-Supported PCR Laboratories|
|Lagos State University Teaching Hospital (LASUTH)||Ikeja, Lagos State||COBAS Taqman/Ampliprep|
|Our Lady of Apostle (OLA) Hospital||Jos, Plateau||COBAS Taqman|
Table 4: PCR Laboratories Previously Managed by APIN
|PCR Laboratories Previously Supported by APIN|
|68 Military Reference Hospital, Yaba||Yaba, Lagos State||COBAS Amplicor|
|Ahmadu Bello University Teaching Hospital (ABUTH)||Zaria, Kaduna State||COBAS Taqman/Ampliprep|
|University of Maiduguri Teaching Hospital (UMTH)||Maiduguri, Borno State||COBAS Taqman/Ampliprep|
|University of Nigeria Teaching Hospital (UNTH)||Ituku-Ozalla Enugu State||COBAS Taqman|
|Federal Medical Center (FMC)||Makurdi, Benue State||COBAS Taqman/Ampliprep|
Table 4: Supported Gene Sequencing Laboratories
|Supported Gene Sequencing Laboratories|
|NIMR Human Virology Laboratory||Yaba, Lagos State||Applied Biosystem|
|Jos University Teaching Hospital (JUTH)||Jos, Plateau State||Applied Biosystem|
|University College Hospital (UCH)||Ibadan, Oyo State||Applied Biosystem|
National EID Commodity Logistics
APIN is the sole supplier of EID laboratory commodities (DBS collection bundles, HIV-1 DNA PCR reagents and consumables) for the national EID program in Nigeria. This supplies cover both the Global Fund and PEPFAR supported PMTCT programs.
Development of National Policies and Guidelines
Our staff are members of different national Technical Working Groups and committees, and have significantly been contributing in policy formulation, guideline development and review, development and review of training curriculum, participation in surveillance studies and protocol development, facility monitoring and assessment, accreditation audits, training facilitation, national commodity forecast and quantification, and other activities of national interest.
National HIV and Drug Resistance Surveillance
Our team and supported facility laboratories have been playing active roles and providing needed technical capacity and laboratory support to the national HIV program in facilitating HIV surveillance studies, Drug resistance surveillance studies, etc.
National Trainings and Accreditation
Our technical team are members of the Nigeria team for Strengthening Laboratory Management Towards Accreditation (SLMTA), a Master Trainer for the SLMTA program, and a Certified Auditor and Mentor for the SLIPTA program. These APIN team members provide support to the SLIPTA program both in Nigeria and Africa by facilitating SLMTA trainings, participating in SLIPTA audits, SLIPTA mentorship, etc. We also provide technical assistance to other local and regional institutions supporting laboratories for accreditation.
FACT SHEETS ABOUT APIN LABORATORY PROGRAM
1. Two (2) APIN supported laboratories (NIMR TB Reference Laboratory, and NIMR Human Virology laboratory) are the first laboratories in Nigeria and Africa to receive 4-Stars certification in the WHO-AFRO SLIPTA program.
2. APIN has four (4) of its supported labs NIMR TB, NIMR HVL, JUTH Jos, and UCH Ibadan) with 4-Stars certification in the WHO-AFRO SLIPTA program. This is highest number from any individual organization in Nigeria and Africa.
3. APIN is supporting 3 out of the 4 drug resistance testing laboratories in Nigeria.
4. The largest contribution to HIV viral load testing in Nigeria is made by APIN.
5. 22% of PCR laboratories integrated into the National EID program is supported by APIN.