Administrative Order No. 2019 – 0001

 10 January 2019

 

GUIDELINES ON THE IMPLEMENTATION OF RAPID HIV DIAGNOSTIC ALGORITHM (rHIVda)

 

I.     RATIONALE

The Philippines registered the fastest growing HIV and AIDS epidemic in Asia Pacific in the past ten years. The reported case of HIV has increased from one case per day in 2007 to 31 newly diagnosed cases per day in 2017. Unprotected sex remains the leading mode of transmission, with men having sex with comprising 83% of the number of new cases. The HIV infection is also transmitted through male – female sex, needle sharing among injecting drug users, and mother to child transmission.

Until 2015, the country is using Western Blot test as part of the HIV Confirmatory algorithm. The average waiting time of confirmatory test result is around seven to ten days but may reach up to three weeks when referring laboratories pool their specimens before sending to the National Reference Laboratory – San Lazaro Hospital / STD AIDS Cooperative Central Laboratory (NRL – SLH/SACCL) to lessen the courier service expenses. The long waiting period of confirmatory test leads to delay in HIV treatment initiation.

With increasing trend of HIV cases, there is a need for early recognition of HIV cases. In low prevalence countries, WHO recommends testing algorithms of sequential combinations of two or three tests (immunoassay and/or rapid tests) which can be reliably used to rapidly confirm HIV infection. Thus, the introduction of Rapid Diagnostic Tests (RDT) in other countries has become an important strategy to increase access to HIV testing, reduce long waiting time for laboratory results, reduce undiagnosed cases, prevent HIV transmission, and provide immediate HIV Testing Services (HTS) to prolong and improve quality of life of People Living with HIV (PLHIV).

Hence, the National HIV, AIDS and STI Prevention and Control Program (NASPCP) is introducing the use of rapid HIV diagnostic algorithms (rHIVda) as the new HIV confirmatory test in the Philippines. This issuance is adopting the HIV diagnostic algorithm validated and piloted in eight sites around the country as a collaborative work of the Department of Health – Disease Prevention and Control Bureau (DOH (DPCB), World Health Organization (WHO), and National Reference Laboratory – San Lazaro Hospital / STD AIDS Cooperative Central Laboratory (NRL) – Australia in 2014 to 2015.

II.    OBJECTIVES

A. General Objective:

To provide implementation policies and guidelines for the use of rapid HIV diagnostic algorithm (rHIVda) as the new HIV confirmatory test in Certified rHIVda Confirmatory Laboratory (CrCL) facilities.

B. Specific Objective:

1. To provide standards for the establishment of CrCL.

2. To outline the operational guidelines for rHIVda.

3. To outline the roles and responsibilities of different DOH units and other stakeholders.

III.  SCOPE AND COVERAGE

This policy shall cover Social Hygiene Clinics and HIV testing laboratories except Medical Facilities for Overseas Workers and Seafarers (MFOWS). The rHIVda is intended to be used in both general and key HIV populations.

IV.   DEFINITION OF TERMS

1. Certified rHIVda Confirmatory Laboratory (CrCL) – a DOH–licensed clinical laboratory compliant with rapid HIV diagnostic algorithms (rHIVda) laboratory standards and technical requirements set by the National HIV, AIDS and STI Prevention and Control Program (NASPCP) and National Reference Laboratory – San Lazaro Hospital / STI, AIDS Central Cooperative Laboratory (NRL – SLH / SACCL).

2. Clinical Laboratory – a facility where tests are done on specimens from human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases. These includes, but not limited to, the following disciplines: Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Histopathology, Cytology, Toxicology, Endocrinology, Molecular Biology and Cytogenetics. Other functions of the clinical laboratory are to provide consultative advisory services covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation. Facilities that are involved in the pre –analytical processes, such as collection, handling and preparation of specimens, or act as mailing or distribution center, such as in a laboratory network or system are also considered to be a part of a clinical laboratory. The total testing process includes pre–analytical, analytical, and post analytical procedures (DOH A.O. No. 2007 – 0027)

3. Enhanced HIV/ AIDS and ART Registry of the Philippines (eHARP) – an electronic case–based reporting and database system maintained by the Epidemiology Bureau for reporting use of HIV treatment hubs, primary HIV care facilities, and CrCL facilities.

4. HIV Testing – refers to initial serological test to determine the presence of antigens and/or antibodies against HIV, performed by a HIV–proficient medical technologist (A.O. No. 2017 – 0019)

5. HIV Testing Services (HTS) – full range of services accompanying HIV testing including counselling (pre–HIV test and post–HIV test); linkage to appropriate HIV prevention, treatment and care services and other clinical and support services with proper coordination with reference laboratories to support quality assurance and delivery of accurate results (A.O. No. 2017 – 0019).

6. HIV Testing Services (HTS) facility – any health facility providing HIV testing services. This can offer stand–alone HTS or incorporated into existing healthcare support services to People Living with HIV (PLHIV) including but not limited to HIV testing services, clinical management, patient monitoring, and other care and support services. Antiretroviral (ARV) treatment can be accessed through these facilities.

7. Key population – members of this population are males who are having sex with males, people in prisons and other closed settings, people who inject drugs, sex workers, and transgender men and women (A.O. No. 2017 – 0019).

8. Non–certified rHIVda Confirmatory Laboratory (Non–CrCL) – a clinical laboratory where HIV screening test is performed but is unauthorized to perform HIV confirmatory test (i.e., rHIVda, Western Blot or PCR).

9. Non–reactive Result – when an HIV testing or screening procedure indicates absences of HIV antibodies and/or antigens.

10. Quality Assurance (QA) – a planned, and systematic intervention done by testing laboratories that aims to ensure that their services and processes will satisfy given requirements for quality.

11.  Quality Management System (QMS) – a comprehensive and integrated organizational approach that provides guidance and support to achieve quality in all components of HIV testing using rHIVda.

12.  Rapid HIV diagnostic algorithms (rHIVda) – uses a combination of 2 or 3 rapid test formats done in parallel or sequence on a sample that had a reactive result in the initial test (A.O. NO. 2017 – 0019).

13.  Reactive result – when an HIV testing or screening procedure indicates presence of HIV antibodies and/or antigens. This result should be confirmed using the current diagnostic algorithm.

14.  Regional Laboratory Quality Officer – a dedicated DOH – Center for Health Development (CHD) personnel to monitor and provide technical support CrCL in compliance with laboratory standards and technical requirements.

15.  Social Hygiene Clinics – these are clinics of local government unit (LGU) that specialize in the management of Sexually Transmitted Infections (A.O. No. 2017 – 0019).

V.    GENERAL GUIDELINES

1. The Disease Prevention and Control Bureau (DPCB shall provide overall direction in the nationwide implementation of rHIVda as confirmatory test for HIV.

2. The rHIVda shall be a combination of three WHO prequalified and FDA registered HIV Rapid Diagnostic Tests (RDT).

3. The rHIVda shall be established in government clinical laboratories, HIV Treatment Hubs, Social Hygiene Clinics (SHC), HIV Testing Services (HTS) facilities, private and project–based HIV clinics that passed the laboratory standards and technical requirements of a Certified rHIVda Confirmatory Laboratory (CrCL).

4. Only DOH–licensed and Certified rHIVda Confirmatory Laboratory is allowed to issue an official confirmatory result based on rHIVda algorithm.

5. Confirmatory test results released by CrCL shall be acknowledged for PhilHealth Out–Patient HIV and AIDS Treatment (OHAT) package enrolment.

6. Quality Assurance Program for rHIVda shall include, but not limited to lot testing, National External Quality Assurance (NEQAS), and validation, monitoring, and supervision to ensure correct laboratory testing and diagnosis, appropriate management of specimens, recording and releasing of results.

7. Strong collaboration with LGU shall be developed to ensure compliance of CrCL to laboratory standards and sustain its operations.

VI.  SPECIFIC GUIDELINES

A. Establishment of Certified rHIVda Confirmatory Laboratory (CrCL)

1. Any public clinical laboratories interested to establish a CrCL shall submit a Letter of Intent to DOH Regional Director.

2. Areas with high prevalence of HIV and HTS facilities initially supported by Global Fund Project – New Funding Model (NFM) shall prioritize in the establishment of CrCL.

3. A certificate “Certified rHIVda Confirmatory Laboratory (CrCL)” shall be issued by NRL – SLH/SACCL or its regional counterpart to a public clinical laboratory which met rHIVda laboratory standards and technical requirements. The CrCL certificate is a pre–requisite for the issuance of LTO, which is valid for 2 years, by HFSRB or Centers for Health Development – Regulatory, Licensing and Enforcement Division (CHD – RLED).

4. For laboratory with existing LTO, rHIVda shall be applied as additional service to existing DOH – LTO.

5. For laboratory without existing DOH – LTO, it shall receive a CrCl certificate from SACCL before it can apply to DOH for LTO as laboratory with limited capacity. (Refer to A.O. 2007 – 0027, Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines).

6. Clinical Laboratories which need technical assistance to meet requirements for certification shall be supported by the CHD – HIV/STI Program and/or the designated Quality Laboratory Officer.

7. Licensing of CrCL shall be under the responsibility of the Health Facilities and Service Regulatory Bureau (HFSRB) as defined in Administrative Order No. 2018 – 0016 or the Revised Guidelines in the Implementation of the One–Stop Shop Licensing System.

B. Capability–building

1. For the first 2 years of implementation, training, on rHIVda for Medical Technologists of CrCL shall be provided by the NRL – SLH/SACCL.

2. The NRL shall accredit training institutions to provide accessible and sustainable HIV proficiency training for medical Medical Technologists in different regions.

3. A pool of trainers shall be established by NRL – SLH/SACCL to cascade rHIVda training and provide continuing technical support to CrCL.

C. Human Resource

1. HIV proficiency certification shall be required to any Medical Technologists who will perform rHIVda.

2. There shall be adequate number of Medical Technologists in a CrCL. The standard number of medical technologists shall be based on the ratio of one medical technologist to manually perform 50 laboratory test per eight hours. Additional staff depends on workload (10 minutes/test). (Refer to A.O. No. 2007 – 0027).

D. Laboratory Testing

1. The rHIVda algorithm shall be done in sequence of three WHO pre–qualified and FDA registered Rapid Diagnostic Tests (RDTs) pre–selected by NRL – SLH/ SACCL in coordination with NASPCP.

2. Test 0 (T0) reactive blood specimens from Non–CrCL shall be sent to CrCL for confirmatory test along with the Laboratory Request Form for HIV Testing (See Annex 4). Only reactive blood specimen referred from Non–CrCL facility shall be accepted by CrCL facility.

3. Walk–in clients in CrCl facility without T0 result shall tested using rHIVda Test 1 (T1). If T1 result is non–reactive, release result as non–reactive. If T1 result is reactive, test specimen using rHIVda Test 2 (T2). If T2 result is reactive, test specimen using rHIVda Test 3 (T3). If T3 result is reactive, release result as HIV positive.

4. Clients with T0 reactive results from Non–CrCL facility shall be tested using rHIVda Test one (T1). If T1 result is reactive, test specimen using rHIVda test 2 (T2). If T2 result is reactive, test specimen using rHIVda Test 3 (T3). If T3 result is reactive, release result as HIV positive.

5. If rHIVda result is Inconclusive or there is any inconsistency with T1, T2 and T3 results, follow recommendations in Annex 1. Interpretation and release of Inconclusive Results.

E. Interpretation and Release of Result

1. HIV POSITIVE result shall be released if three rHIVda results are all reactive (T1+, T2+, T3+).

2. HIV NEGATIVE result shall be released if the following conditions are satisfied:

a. T0 test is not done and T1 result is non–reactive for walk–in clients in CrCL.

b. If repeated T1 is non–reactive for second time (Two T1 non–reactive results).

3. HIV INCONCLUSIVE result shall be reported if there is any inconsistency with screening and/or rHIVda RDT results. Combinations are as follows:

a. T0 results is reactive, T1 result is non–reactive (T0+, T1–)

b. T1 result is reactive, T2 result is non–reactive (T1+, T2–)

c. T1 result is reactive, T2 result is reactive, T3 result is non–reactive (T1+, T2+, T3–)

4. The confirmatory test result released by CrCL shall be signed by HIV–proficient Medical Technologists and Pathologist.

5. All results shall be released to client during post–test counselling sessions. (Refer to A.O. No. 2017 – 0019)

F. Data Management

1. All CrCL shall have a designated data management point person.

2. All rHIVda–related processes must be properly documented and recorded, including errors and gaps in the processes in the laboratory workbook/registry.

3. All CrCL shall maintain daily client registry and shall submit monthly monitoring report to NASPC Coordinator of their respective LGU every Friday of the month. These collected reports shall be submitted by the DOH Regional Coordinator to the Disease Prevention and Control Bureau (DPCB) every three months.

4. All CrCL shall report all rHIVda clients’ data to the Epidemiology Bureau using the eHARP software. (See Forms in Annex 2 and 3).

G. Quality Assurance

1. Lot Testing

a. The NRL – SLH/SACCL shall subject samples per lot number of rHIVda RDTs to evaluation prior to shipment to CrCL.

b. Consolidated report shall be submitted by NRL to DPCB every lot number tested.

2. National External Quality Assessment Scheme (NEQAS)

a. The CrCL shall participate in the annual National External Quality Assessment Scheme (NEQAS) implemented by NRL – SLH/SACCL.

b. The CrCL passing the NEQAS shall receive certificate valid for 1 year.

c. The CrCL that will not pass the NEQAS shall be subjected to onsite assessment, retraining and close monitoring of performance until all recommendations are satisfactory met; and/or cancellation of CrCl certificate.

d. An annual report on NEQAS shall be submitted by NRL to DPCB and HFSRB, to be used as reference in renewing DOH – LTO of clinical laboratories.

3.     Monitoring and Supervision

a. The CrCL shall comply with Quality Management System (QMS) policies and procedures.

b. Monitoring of the CrCL performance shall be assessed regularly by the Quality Assessment Team composed of NRL – SLH/SACL, CHD and/or DOH Central Office – HIV Program.

c. Technical laboratory supervision shall be provided as necessary or upon CrCL request.

H.   Monitoring and Evaluation

1. Program performance indicators shall be used as basis for the conduct of monitoring and evaluation activities.

2. Monitoring of rHIVda programmatic outcomes shall be covered by the annual Health Sector Strategic Plan for HIV of the NASPCP.

VII. ROLES AND RESPONSIBILITIES

A. Disease Prevention and Control Bureau (DPCB)

1. Together with NRL – SLH/SACCL, develop standards and technical requirements for a CrCL.

2. Endorse the list of potential CrCL laboratories to NRL – SLH/SACCL.

3. Oversee the creation of rHIVda pool of trainers to implement decentralize training and other capability building activities for health workers.

4. Provide rHIVda commodities to government CrCL through CHD.

5. Support NRL – SLH/SACCL in preparation of budget proposal in the implementation of rHIVda and NEQAS.

6. Collaborate with the National Voluntary Blood Donation Safety Program (NVBSP) to provide constant supply of blood for NEQAS implementation in the CrCL.

7. Conduct health promotion and advocacy activity for rHIVda service.

8. Conduct monitoring, supervision, and evaluation activities of rHIVda implementation.

B. Epidemiology Bureau (EB)

1. Integrate rHIVda reporting in the current HIV surveillance system.

2. Conduct training on Data Management and Encoding for rHIVda.

3. Ensure all CrCl submission of reports to HIV surveillance system.

4. Provide HIV surveillance report to DPCB.

C. Health Facilities and Services Regulatory Bureau (HFSRB)

1. Set minimum licensing standards for HIV testing laboratories.

2. Issue License to Operate (LTO) to compliant laboratories applying for rHIVda.

3. Disseminate regulatory policies and standards for information and compliance.

4. Provide list of licensed CrCL sites to PhilHealth and DPCB.

D. National Reference Laboratory – San Lazaro Hospital – STD AIDS Cooperative Central Laboratory (NRL – SLH/SACCL)

1. Assess and certify clinical laboratories and clinics as “Certified rHIVda Clinical Laboratory (CrCL)” based on certification requirements.

2. Validate inconsistent rHIVda results.

3. Develop Proficiency Training Program, training modules, monitoring, and supervision tools for pool of trainers pursuant to the implementation of this guidelines.

4. Continually assess diagnostic kits with potential use for rHIVda and shall provide updated list of in – vitro diagnostic kits and combination of rapid tests.

5. Provide Proficiency Training and certificates to Medical Technologists and rHIVda trainers.

6. Provide technical assistance, mentorship, and supervision to CrCl in the development of site standard operating procedures (SOPs), job aids (work instructions) and internal quality assurance procedures.

7. Oversee the implementation of Quality Assurance Program (QAP) together with NASPCP and CHD.

8. Conduct regular National External Quality Assurance Scheme (NEQAS).

9. Provide list of certified facilities to HFSRB and DOH – RLED regularly for validation of certificates submitted by the facility when they apply for LTO.

10.  Provide feedback and recommendations on the performance of CrCL to NASPCP regularly.

E. Center for Health Development (CHD) – HIV/STI Program

1. Coordinate and disseminate rHIVda guidelines to HIV stakeholders and partners.

2. Lobby with Local Chief Executives (LCEs) in setting up CrCL in identified areas with high prevalence of HIV.

3. Endorse to Disease Prevention and Control Bureau (DPCB) the list of potential CrCL facilities.

4. Support the compliance of CrCl to required technical and standard requirements / Quality Management Systems of rHIVda laboratories.

5. Designate Regional Quality Officer and provide support and technical assistance to clinical laboratories and facilities to ensure readiness to comply with laboratory standards and technical requirements in establishing CrCL.

6. Lead the creation of rHIVda pool of trainers.

7. Together with NRL – SLH/SACCL, organize training, mentoring and coaching activities for CrCL health workers following NASPCP policies and direction.

8. Provide rHIVda testing kits and other consumables to CrCL.

9. Conduct monitoring, supervision, and evaluation activities of rHIVda implementation.

10.  Regularly collect and analyze regional supply inventory reports, monitoring, and supervision reports, and provide feedback to DPCB.

F. PhilHealth

1. Inform and provide list of accredited CrCL facilities for OHAT claims.

2. Coordinate with HFSRB for regular updates of CrCl list.

G. DOH Hospitals and HIV Treatment Hubs

1. Establish CrCL in their respective laboratories.

2. Accept and manage clients with HIV positive results from CrCl and/or NRL – SLH/SACCL.

H.   Local Government Units

1. Support the establishment and maintenance of CrCL in their respective areas, including but not limited to, provision of laboratory space, additional funds for hiring of human resource, additional commodities, and other logistical needs.

2. Institutionalize the implementation of rHIVda in HIV testing facilities in their area of jurisdiction.

3. Support CrCL to comply with standards and requirements for rHIVda.

I. Certified rHIVda Confirmatory Laboratories (CrCL)

1. Release accurate laboratory result on the same day the specimen is received.

2. Ensure confidentiality of laboratory results.

3. Develop, update, sustain and strictly implement standard operating procedures (SOP), job aids (work instructions), and Quality Management System (QMS) for a CrCL facility.

4. Establish and maintain good coordination with CHD, NRL – SLH/SACCL, HIV testing and treatment facilities, LGU, CBO, NGO and other agencies to facilitate efficient rHIVda implementation and service delivery.

5. Participate in NEQAS by NRL – SLH/SACCL.

6. Advocate for logistical and human resource supports for rHIVda.

7. Submit reports to CHD and DOH – Epidemiology Bureau.

VIII.  FUNDING

The DOH – DPCB shall allocate budget for the implementation of these guidelines, including but not limited to, augmentation of rHIVda test kits and consumable, conduct of capacity building activities, monitoring, supervision, and evaluation activities. The Local Government Units (LGU) shall be tapped to provide financial support for the implementation of these guidelines that shall be included in their respective annual budgets.

IX.   REPEALING CLAUSE

Provisions in previous issuances inconsistent and contrary to this Administrative Order are hereby rescinded and repealed.

X.    EFFECTIVITY CLAUSE

This Administrative Order shall take effect immediately. All implementing agencies are required to strictly follow this directive.

 

FRANCISCO T. DUQUE, III, MD, MSc.

Secretary of Health

 

ANNEX 1: INTERPRETATION AND RELEASE OF INCONCLUSIVE RESULTS

TEST RESULT IN CrCL	INTERPRETATION OF HIV STATUS	RECOMMENDATION	REMARKS
1. T1 Non–Reactive	Inconclusive	Repeat rHIVda after 2 – 6 weeks   (Send specimen to SACCL for data collection)	To come back after 2 – 6 weeks
Same result after Return 1	Negative	– release negative result   (Send specimen to SACCL for data collection)	Post – test counselling
2. T1 Reactive / T2 Non–Reactive	Inconclusive	Repeat rHIVda after 2 – 6 weeks   (Send specimen to SACCL for data collection)	To come back after 2 – 6 weeks
Same result after Return 1	Inconclusive	Repeat rHIVda after 2 – 6 weeks   (Send specimen to SACCL for data collection)	To come back after 2 – 6 weeks
Same result after Return 2	Inconclusive	Request final result from SACCL   (Send specimen to SACCL for data collection)	Release final result from SACCL
3. T1 Reactive T2 Reactive T3 Non–Reactive	Inconclusive	Repeat rHIVda after 2 – 6 weeks   (Send specimen to SACCL for data collection)	To come back after 2 – 6 weeks
Same result after Return 1	Inconclusive	Repeat rHIVda after 2 – 6 weeks   (Send specimen to SACCL for data collection)	To come back after 2 – 6 weeks
Same result after Return 2	Inconclusive	Request final result from SACCL	Release final result from SACCL