Fred Odhiambo. NPHL Launches a National Centre of excellence for Public Health Laboratory Services and Influenza Centre and a five year Strategic Plan

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1 MINISTRY OF HEALTH April 2017 NATIONAL PUBLIC HEALTH LABORATORY Issue 2 EDITOR S NOTE elcome and enjoy reading this W 2nd issue of the NPHL bulletin. In the 1st issue, we highlighted events that characterized the evolution of NPHL, milestones in infrastructural transformation, service delivery, quality assurance, attainment and maintenance of accreditation status among other activities. In this issue we feature activities and events that defined NPHL in the first quarter of 2017 which included the launch of the NPHL five year strategic plan, Centre of Excellence (CoE) for equipment management, laboratory policy guideline documents and accreditation of the National Microbiology Reference Laboratory, among others. The NPHL Quarterly bulletin gives us a communication platform on which to highlight strategic achievements of the division through written articles. We have posted this bulletin on our website where we share more information to keep abreast with the emerging issues. We invite your feedback, including suggestions on areas you need covered in the subsequent issues. I wish to acknowledge the contribution of authors of articles and pictorials in this issue. Finally, I wish to thank members of the editorial team for objectively reviewing the written articles for this bulletin. Fred Odhiambo Editor-in-chief NPHL Launches a National Centre of excellence for Public Health Laboratory Services and Influenza Centre and a five year Strategic Plan On 6 April 2017 the National Public Health Laboratory (NPHL) launched a Centre of Excellence (CoE) for equipment management, laboratory policy guideline documents and accreditation of the National Microbiology Reference Laboratory. The CoE which was established in collaboration with PEPFAR partners and CDC Kenya will offer calibration services to the public laboratories and serve as a center of excellence in equipment maintenance as well as a learning centre for biomedical engineering technologists. Thirty biomedical engineering technologists and 12 trainer of trainers (TOTs) have already undergone training at the centre to assist in the strengthening of equipment preventive maintenance programs and improving the quality of laboratory services, the Director of Medical Services (DMS), Dr. Jackson Kioko who was represented by Dr. Pacifica Onyacha, the Head of Department of Quality and Standards at the Ministry of Health said at the launch. She said the national public laboratory is essential for achievement of the Ministry of Health policy objectives particularly the elimination of communicable diseases, provision of essential healthcare and decreasing the burden of non-communicable diseases The National Public Health Laboratory is key in protecting the health of Kenyans against emerging and re-emerging health threats as mandated in the current constitution dispensation, Dr. Pacifica Onyancha said. The National Public Health Laboratory performs specialized testing for priority infectious and non-communicable diseases, laboratory-based disease surveillance, provision of quality assurance for the public health laboratories and referral services linking national, international and county laboratories. The Laboratory is responsible for surveillance, detection, response and control of disease threats and outbreaks; as well as effective planning, implementation, monitoring and evaluation of public health programs. The DMS representative also opened the National influenza Centre (NIC) which is a public health laboratory facility established by the Ministry of Health with the mandate to conduct Influenza surveillance. The centre will offer services to the private, national referral & county public health institutions, public institutions, and also serve as a resource for training on influenza surveillance in Kenya and beyond, by providing information summaries that are crucial in the assessment of influenza public health trends and epidemic dynamics on a national scale.

2 UPDATES FROM NPHL NPHL centre of excellence for equipment management conducts refresher training of biomedical engineering technologists For a long time, public health laboratories have faced a big challenge of non-functional laboratory equipment and unsustainable service contracts, which has had a negative impact on patient results. To address this challenge the National Public Health Laboratory (NPHL) in partnership with American International Alliance (AIHA) and Association of Public Health Laboratories (APHL) through PEPFAR/CDC funding have embarked on a program to capacity build biomedical engineering technologists, Laboratory technologists and technicians on laboratory equipment management which involves; needs assessment, equipment selection, use, maintenance, retirement and disposal. In this regard, a training of trainers was conducted in April 2017 to equip Biomedical Engineering technologists with the requisite skills to service and maintain laboratory equipments. Ms Charity Maina, the head of the Centre of Excellence for equipment management said that as more laboratories enroll for the accreditation process, equipment management component is very key and takes a substantial proportion (35%) of the marks on the Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) checklist She observed that due to lack of proper equipment management program, some of these laboratories are lagging behind in the journey to achieving the quality they so desire. Properly functioning medical laboratory equipment, that is well serviced, maintained, and calibrated gives correct results and guarantees uninterrupted services which is central to the diagnostic and analytic needs in clinical operations, she stated. Ms Maina said the training offered in-depth hands-on sessions where the participants were able to repair broken down equipments and service the functioning ones at the NPHL creating huge excitement and signaling a major paradigm shift in the maintenance of laboratory equipments. Follow up has been conducted in the various facilities with impressive reports. As a results of this training, the NPHL will henceforth not procure service contracts for the eleven (11) basic laboratory equipments because our resident Biomedical Engineering technologists are now able to service, maintain and repair them thus reducing maintenance costs, said Ms Maina. She further disclosed that the program has also procured modern tool kits for all the biomedical engineering technologists. A Biomedical Engineer Ms. Victoria Chausiku explaining to the team led by Dr. Onyancha how a biosafety cabinet works 2

3 NPHL Launches a 5 year Laboratory Strategic Plan The Government of Kenya has entrenched strategic planning as a mechanism to improve efficiency and effectiveness in public service delivery. In line with this, NPHL 5-year strategic plan describes how the division will support the implementation of the Ministry of Health (MoH) strategic plan as well as an achievement of the goals of the Kenya Health Sector Strategic and Investment Plan ( ) and the Kenya Health Policy ( ). This is in addition to global obligations such as the International Health Regulations and the global UNAIDS 90:90:90 targets for HIV management. The aim of NPHL Strategic Plan is to define the division s strategic direction towards achieving its core mandate of delivery of safe, reliable, quality laboratory services that meets national health priorities and international requirements and standards. It is important to note that an effective and efficient national public health laboratory system is essential for achievement of policy objectives particularly the elimination of communicable diseases, provision of essential healthcare and containing the burden of non-communicable diseases. Public health laboratories also have an important role in surveillance, detection, response and control of disease threats and outbreaks; as well as effective planning, implementation, monitoring and evaluation of public health programs. Achievement of this task necessitates having a documented comprehensive road map to help focus on the set priorities and targets. Five thematic areas have been identified to guide the development of the NPHL strategic plan: 1. Laboratory Services 2. Monitoring, Evaluation; ICT and Communication 3. Quality Management, Accreditation, Biosafety and Biosecurity 4. Leadership, Governance, Partnership, Financing and Human Resource 5. Infrastructure, Equipment and Logistics Strategic interventions have been developed for each of the thematic areas. The thematic areas are supported by one or more overall goals, objectives, strategies and a number of activities that build towards strategic direction and achievement of objectives. Implementation of this strategic plan will enhance and strengthen the planning and resource mobilization efforts for the institution. A cake to commemorate the NPHL Strategic Plan

4 NPHL sets up a Centre of Excellence for Equipment Calibration, Certification and Training Currently in Kenya there is a gap in equipment maintenance in the laboratories. Most of the equipment s used in the laboratories are not maintained due to lack of resources pegged on high cost involved. There is no program on laboratory equipment maintenance in the country due to prohibitive costs. The situation is exacerbated by the increased number of laboratories enrolled in Strengthening Laboratory Management Towards Accreditation (SLMTA) program which requires that for any laboratory to be accredited, equipment management is a must. The training on the biomedical engineering technologists currently done in the institutions is on obsolete technology. With the change in technology, there is need therefore for the therse technologists to be trained on the new technology. The calibration centre will offer calibration services to the public, serve as a learning centre for biomeds and act as a center of excellence in equipment maintenance This will assist in the strengthening of equipment preventive maintenance program and ensure sustainability of equipment calibration. This project in turn complements the laboratories in the country in getting ISO Certified as a requirement of the quality management system. This program has contributed greatly in improving the quality of laboratory services in Kenya. Dr Onyancha unveils the plaque for the equipment calibration centre. Looking on are Dr Mark-Alain Widdowson of the Division of Global Health Protection (DGHP) - CDC and Mr Mamo Umuro, Head NPHL Dr Onyancha cuts a tape to officially open the equipment calibration centre. Looking on is Ms Charity Maina, Head of Quality Assuarance at NPHL 4

5 NPHL LAUNCHES EIGHT LABORATORY POLICY GUIDELINE DOCUMENTS 1. The National HIV Viral Load Testing Scale-Up Strategic Plan : The Strategic Plan sets targets, strategies and activities along the treatment cascade to increase access to, coverage of, and quality of testing for viral load 2. A laboratory supportive supervision and mentorship guideline: This guideline outlines mentorship methodology for national and county levels. The national level will provide mentorship and technical support while the county level will provide support supervision and mentorship. 3. National Integrated External Quality Assessment Strategy for Medical Laboratory Services : This strategy is developed in line with the Quality Policy Manual for Medical Laboratories in Kenya (2012) & ISO which establishes overall policies for the national quality management system for the medical laboratory services in Kenya. 4. Quality Rapid HIV Testing in Kenya: Training Manual for Training of Trainers/Laboratory Supervisors Curriculum 2015: This training manual outlines the 12 modules required for training trainers and laboratory supervisors in QMS for HTS 5. National HIV Test Kit Evaluation Guideline 2015: this document is intended to act as practical guide and reference to the laboratory personnel who conduct evaluations of HIV rapid/eia tests. 6. Operations manual for guiding the implementation of quality assurance in rapid HIV testing in Kenya: This is an integrated testing quality manual for HIV/AIDS related policy guidelines. This operational manual is intended to strengthen implementation of quality assurance in rapid HIV testing in all service delivery points. 7. Framework for The Implementation of HIV Related Point of Care Testing Policy And Quality Assurance 2015: This framework aims to support efforts towards developing and strengthening existing POCT policies and initiatives to assure reliable and accurate client results. 8. The Integrated Laboratory Point of Care Testing Policy Guideline 2015: The objective of this guideline is to streamline POCT services that have been historically implemented in other countries and solidify operational practices. Dr Mark-Alain Widdowson of DGHP receives the guidelines and policy documents that were launched from the chief guest Dr Pacifica Onyancha 5

6 ACCREDITATION OF THE NATIONAL MICROBIOLOGY REFERENCE LABORATORY Marks a major milestone in Laboratory Practice in Kenya NPHL in April celebrated the accreditation of the National Microbiology Reference Laboratory which became an ISO 15189:2012 accredited laboratory in The laboratory conducts microbiological testing on water, food and environmental samples. It also performs specialized tests such as typing and characterization of common microorganisms and antimicrobial resistance (AMR) surveillance. Accreditation means that the laboratory has set up the required international Quality Management System (QMS) in all the areas including customer care, well serviced equipment, and quality assurance of the patient from the time the patient gives the samples for testing, processing the sample the right way, to the point where the patient is given the results The accreditation of the laboratory is very important for the health of the public. Achieving these international standards means that the results that are produced by the laboratory are of high quality for the benefit of the patient. QMS also assures that the reagents (chemicals) used to test the patients samples are of good quality thus validating the results given. Accreditation of this laboratory has also helped other county medical laboratories pursuing the ISO certification through mentorship programs; ensuring that they produce quality results through providing them with proficiency test (PT) panels and training the county laboratory staff on proper testing techniques. Staff of the National Microbiology Reference Laboratory celebrate after receiving an accreditation certificate from KENAS. They were joined by Dr Onyancha and other guests. 6

7 The National HIV Reference Laboratory gets re-accreditation for the second year. The National HIV Reference Laboratory (NHRL) attained ISO certification in 2013 and has maintained the accreditation status to date. It is important to note that the NHRL was the first public laboratory in the ministry of healthy to get accreditation and is charged with the responsibility of coordinating laboratory testing in HIV diagnostics, DNA for early infant diagnosis (EID), antiretroviral treatment (ART) monitoring (Viral load, CD4, Biochemical tests) as well as providing technical support and leadership in HIV Quality Assurance. The laboratory also serves as a hub to national laboratory-based HIV surveillance studies for estimation of country HIV prevalence and incidence, HIV drug resistance monitoring and special population based surveys. The laboratory is a center of excellence and offers training and mentorship to county laboratories and labs undergoing the SLIPTA process Among the land mark achievements of NHRL for the past years is successful organisation of the Kenya AIDS Indicator Survey (KAIS, 2007 and 2012), coordination of national HIV Viral load, EID scale-up and HIV drug resistance testing. The laboratory is also taking a lead in the evaluation of new technology such as point of care testing (POCT) to enhance access of HIV molecular laboratory testing services at the point of testing in the country. In regards to quality assurance in HIV testing, the laboratory has an established proficiency testing (PT) scheme the largest PT scheme in Sub Saharan Africa. This targets all HIV testing service providers conducting HIV rapid testing. The scheme has revolutionized quality of HIV testing and result acceptability by clinician and the public at large. The National HIV Reference Laboratory was established in the year 2003 to assure the quality of HIV testing services in Kenya. It is housed within NPHL campus and acquired a state of art laboratory courtesy of US PEPFAR in Mr Mamo Umuro receives the accreditation certificate from the Chief guest Dr Pacifica Onyancha during the launch 7

8 QUALITY ASSUARANCE FOR HIV RAPID DIAGNOSTIC TEST The laboratory has established the largest proficiency panel testing scheme in Sub Saharan Africa HIV testing services (HTS) is the key entry point into HIV care and treatment services, as well as HIV prevention and intervention. UNAIDS targets of ensuring that 90% of people know their HIV status, 90% of those HIV-positive are receiving treatment and that 90% of those on treatment achieve viral suppression by 2020 will rely heavily on accurate HIV results. Continued expansion and decentralization of HIV testing has resulted in non-laboratory health care personnel offering HTS in a wide range of settings across the country As a way of ensuring the reliability of results, proficiency testing panels from National HIV Reference Laboratory (NHRL) whose composition is unknown to the service providers are used to test the validity of HIV results being given to clients. The use of cutting edge technology in the production of these panels has enabled the PT program to reach over 19,000 testers countrywide. As a quality assurance laboratory, the NHRL remains committed to improving the quality of laboratory results both in Kenya and in the East Africa region. Mr Mamo Umuro, Head of NPHL hands over the accreditation certificate to the Head of the Virology Unit Ms Nancy Bowen. Next to her is Ms. Sophie Mwanyumba, Manager of NHRL and her laboratory staff 8

9 NPHLS opens the National Influenza Centre The National Influenza Centre (NIC) is a public health laboratory facility established by the Ministry of Health (MOH) with the mandate to offer surveillance services and oversee all quality assurance programs. The laboratory offers quality and affordable reference diagnostic testing and surveillance monitoring services to the public and private institution and continually upgrades all the tests to reflect technological change in laboratory medicine.nic is a resource for training on influenza surveillance in Kenya and beyond. NIC receives specimens from county public health institutions and other local and national health institutions and agencies for analysis providing information summaries that are crucial in the assessment of public health trends and epidemic dynamics on a national scale. It serves as the key point of contact between the World Health Organization and Kenya in all questions relating to virological and epidemiological surveillance of influenza and provision of influenza virus isolates to the WHO Global Influenza Surveillance Network Influenza occurs in distinct outbreaks of varying extent every year. This epidemiologic pattern reflects the changing nature of the antigenic properties of influenza viruses, and their subsequent spread depends upon multiple factors, including transmissibility of the virus and the susceptibility of the population. NIC is striving to achieve WHO recognition as a public health Influenza laboratory for the country. We extend our gratitude to our partner CDC and the NPHL fraternity for the support that culminated in the establishment of this laboratory. 9

10 PICTURES OF THE NPHL LAUNCH NPHLS staff during a staff retreat in Naivasha 10

11 Focus on Laboratories NATIONAL ONCOLOGY/BIOCHEMISTRY REFERENCE LABORATORY ADDRESSES THE RISING BURDEN OF NON-COMMUNICABLE DISEASES IN THE COUNTRY Kenya is experiencing an upsurge of non-communicable diseases (NCDs), and is receiving attention in public health policies and programs, commensurate with the disease burden. According to Kenya National Forum on Non-communicable diseases (NCDs) report of August 2011, Non-communicable diseases cause over 50% of all hospital admissions and deaths. It is estimated that by 2030, non-communicable diseases will contribute to over 60% of the total national mortality. The leading causes of deaths due to non-communicable diseases include cardiovascular diseases (13%), cancers (7%) and diabetes (4%) according to the NCD Alliance report. Towards the end of the year 2013, MOH through Department of Preventive and Promotive Health (DPPH) established the National Oncology/ Biochemistry Reference laboratory (NOBRL) under the Division of National Public Health Laboratory (NPHL) to address the rising burden of NCDs through provision of specialized testing. The laboratory performs immunoassays on Prostate Surface Antigen ( PSA) for prostate cancer and cancer markers such as CA 19-9 for pancreas/bile ducts cancer, CA125 for ovarian cancer, Alpha fetoprotein (AFP) for liver cancer; CA 15-3 (Breast cancer), carcino-embryonic Antigen (CEA) for colorectal carcinoma, diabetes screening and monitoring (HB A1c), thyroid function tests (T3, T4 & TSH); and fertility hormones profile. Other tests include renal function tests, bone metabolism, lipid profile and liver function tests. The average turnaround time (TAT) for these tests is 2 hours. The projection of the laboratory is to introduce more specialized test in haematology, cytology, immunohistochemistry, molecular methods and urinary iodine. NOBRL receive walk-in patients from public and private health facilities across the country. Majority of these clients are referred from Kenyatta National Hospital (KNH), Consultants Clinics at KNH doctors plaza, Nairobi county health facilities, Kiambu County health facilities among others. The cost of Thyroid function tests (FT3, FT4 & TSH) is KES 1,500. Fertility hormones, HbA1c, Tumour markers cost KES 1,000 per parameter requested. The cost of Biochemistry tests range from KES 200 to 1,000 depending on the analytes to be tested. These are presumably the most affordable prices in the country, with reliable and quality results in a turnaround time of 24 hrs. 11

12 EDITORIAL TEAM: Head of division: Mamo Umuro Editors: Fred Odhiambo and Redemtor Atieno Writers: John Mwihia, Solomon Gikundi, Christabel Awour, Ruth Mumo, Christabel Misiko, Rosbella Kiplagat, Lily Kirui, Judith Muindi, Peninah Nzioka, Nelson Akenga, Redemtor Atieno and Susan Githii Contributors: Dr. Christina Mwachari, Elvis Kirui and Kenneth Ouma Design and Layout: Graphitec and Redemtor Atieno National Public Health Laboratory Kenyatta National Hospital Grounds, Nairobi, Kenya Website: This newsletter was produced by the National Public Health Laboratory (NPHL) and the Centre for International Health, Education and Biosecurity (CIHEB) Kenya at the University of Maryland UNIVERSITY of MARYLAND SCHOOL OF MEDICINE