I

Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

June 1, 2010

ADMINISTRATIVE ORDER
No. 2010- OO!"O

SUBJECT: Policies and Guidelines in the Conduct of Human

I. INTRODUCTION AIID RATIONALE

The Philippines still maintains less than one (1) percent prevalence rate of HIV infection.
Preventive interventions must be undertaken by the country in order to maintain its low
prevalence status, and the Department of Health and other concemed agencies are focusing
their efforts thereon.

Pursuant to the 4th AIDS Medium Term Plan (2005-2010), HIV counseling and testing is one
of the preventive interventions used to reach the most at risk population. The at-risk and
vulnerable populations for HIV infection include people in prostitution, men having sex with
men, people who inject drugs, and migrant.workers. HIV counseling and testing is being
advocated to the most at risk population because through this intervention, the same are given
the opportunity to know their HIV status and at the samb time are provided with information
on risk reduction strategies and location of facilities to treat HIV positive individual.

Since counseling is anchored on HIV testing, efficient post-test counseling can appropriately
manage the negative consequences of client's knowing their HIV status especially if the client
tested positive for HIV. On the other hand, poor quality counseling which may inadequately
address client issues may result in suicide, depression and other psychological consequences
in persons tested positive for HIV.

Furthermore, the importance of implementing quality counseling anchored on HIV testing as

mandated by Republic Act No. 8504, "AIDS Prevention and Control Act of 1988':, will not
only benefit the individual being tested but will also scale up preventive intervention so as to
slow down or halt the spread of HIV. Hence, there is a need to provide a standard in the
\ conduct of HIV counseling and testing.

Building l, San Lazaro Compound, Rizal Avenue, Sta- Crua 1003 Manila. Trunkline 743-83-01 Direct Line: 7l l-9501
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II. OBJECTIVES

General Objective:
To piovide policies and guidelines in the conduct of HIV counseling and testing (HCT)
at community and health facility settings.

Specific Objectives:
1. To identiff the required comlonents of HIV counseling and testing and set the protocol
for these components;
2. To set the standards/requirements for an HIV counseling and testing facility; and
, 3. To defrne the roles and responsibilities of DOH and other stakeholders in the
implementation of these guidelines.

ilI. SCOPE AND COVERAGE

This guideline covers all Sexually TransmittedInfection (STI) and HIV service
providers, coordinators and man'agers of HIV clinics anilor testing laboratories, all facilities
offering HIV testing for diagnostic prrposes, suroeillance and research,.and blood safety
purposes.

IV. DEFINITIOT{ qF TERMS

1. Blood Service Facility (BSD - ary unit, office or institution providrng any of the blood
transfusion services and which can be a blood center, blood bank, blood collection unit or
blood station.

2. Conlirmatory test/testing- refers to the test performed on samples that have tested reactive
to the screening test to find out if the results were true positive or not.

3. DOH Retained Hospitals- hospitalsfrat remain under the management and supervision of
the Department even after the devolution.

4. Fourth AIDS Medium Term Plan- The five-years Plan containing the country's action and
response towards maintaining the low HIV prevalence status of the Philippines and
preventing theispread of HIV infection.

) Informed written consent-

5. refers to the voluntary written agreement of a person allowing
him/ herself to undergo or be subjected to a procedure based on full infor?nation.

6. Overseas Filipino Workers (OFW) clinics- these are clinics that conduct pre-employment
medical examination for Filipinos bound for abroad.

7. Pre - donation counseling - a process in blood donor selection wherein donors are
informed about health conditions or risk behavior that would make
 donate blood. The donor's informed consent to blood donation and to the blood testing. is
obtained during counseling.

8. Reactive sample- the blood sample from patient /client has antibodies that reacted to the
HIV antigen or vice versa present in the screening test. However, the presence of, reactive
sample does not totally confirm that the person has HIV infection.

g. Screening test- refers to initial serological test performed to determine the presence of
antibody and/or antigen against HIVI and HlVz.

10. Social Hygiene Clinics- these are clinics of the local govemment unit that are usually part
of the municipal/city health office providing reproductive health service including
management of STI.

11. Treatment hub- a hospital facility with an organized HIV/AIDS Core Team (HACT)
providing prevention, treatment care and suppor{ services to People tiving with HIV
(PLHIV) including but not limited to HIV counsfling and testing, clinical management,
patient monitoring and other care and support servi{es. ARV treatment can only be accessed
through these facilities. Refer to Annex II for the list of treament hubs.

12. HMounseling and Testing (HCT) - also called Voluntary Counseling and Testing
(VCT), is a counseling process that enables a client make an informed choice about being
tested for HIV. The counseling process has two components, the pre and post HIV test
counseling.

l2.l Pre-IIIV test iounseting - a process that prepares the client for the HIV test. Pre
HIV test counseling explains the implications of knowing that one is or is not infected
with HIV, facilitates discussion about ways to cope with knowrng one's HIV stiatus, to
enable an individual to practice strategy to reduce future risk behaviors. It can be
Client initiated (CICT) oi provider initiatea HIV counseling and testing (PICT), both
process is voluntary and enables client make informed decision about being tested for
HIV.infection.

12.2 Post HIV test counseling - process conducted by a trained personnel to assist
the client understand and cope with the HIV test result and be bble to identiff
options for future plans including physical, mental, social, reproductive and other
personal concerns.

13 HCT facilify -any health facility equipped in providing services on HIV counseling and
testing recognized by DOH. It can be free-standing or incorporated into existing health-care
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servlces.
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V. GENERAL GUIDELINES

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Pre-test Counseling).

2. All HCT facilities shall be duly licensed and comply with the standards set by the
Departryent of Health for an HIV Testing Center.

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4. All DOH -.licensed OFW clinics shall provide pre-HIV test and post-H]V test_counseling
to all their clients for HIV testing as mandated by Republic Act No. 8504, *AIDS
Prevention and Control Act of 1998". Provision for counseling shall be par.t of the
accreditation requirements of OFW clinics.

5. Blood service facilities (BS.F) shall include in its pre-d"*tt"i."9pseling an assessment

of risk behavior among all'its potential blood donors. All individuals seen at tsSF with

6. All identified treatment hubs (See Annex II) a1{_!_O{11t1ined hospitals shall set-up and
provideHIVcounselingandtestingaspartofHIVAIDSCoreTeam(HACT)services
ard as potential referral facilities for LGU and NGO based HIV counseling and testing
facilities.

. 7. Private and LGU hospitals shall be encouraged to set-up within their sysftlms provision of
HIV counseling and testing services for walk in clients. The said services shall be closely
inked to the HACT of the hospital.

8. , AJl persons who underwent HCT shall be provided with their test rezults with post-test
counseling, except for.testing done during blood donation, surveillance and research
. purposes. No other person shall be provided with the result other than the person tested
except in circumstances allowed by RA 8504 or similar guidelines.

VI. SPECIFICGUIDELINES

1. Conduct of Pre - HIV Test Counseling

I .I. Client - Initiated Counselins and Testins
a. All clients who want to be tested for HIV shall be provided with pre-TIIV test
counseling in a space where privacy could be observed and confidentiality ensured.

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 b. Pre-HIV test counseling shall either be conducted in individual or group settings.
Clients shall be strongly encoura€ed to bring their confidants during the pre- and
post-HIV test counseling.

c. The same counselor is highly recommended to conducJ both pre- and post-test
counseling and, if needed, follow-up sessions for a client.

d. Adult clients shall be counseled in a setting that is safe and secure for both counselor
and client.

e. Pre- and post-HIV test counseling of children shall take into consideration the
maturity oi the client and, when necessury, responsible parents or a legal guardian,
including any registered social worker, shall be inyolved.

f. Counselors shall ensure that clients understand the information piinted on the consent
form. All necessary and correct information that clients need to rnake decisio:rs for
themselves shall be provided.

g. Counselors shall strongly encourage follow-up counseling sessions and ensure that.
clients utilize referral networks that are in place and functional.

. h. All Counselors shall have basic knowledge on voluntary blood donation and
incorporate facts on blood donation when appropriate. ,

L2. Provider - Initiated Counseling and Testins

a. As part of medical management, HIV testing shall be offered by health care
provider to"ALL the following:
1. Clients assessed for STI in an STI clinic or elsewhere;
2., Prcgnantwomen with one or more of the following HIV risks:
i. multiple sex pertners,
ii.
...
personwho inject drags (PWID),
iii. history of STI, including a diagnosis of syphilis,
iv. husband or partner has multiple sex partners, history of STI or is a
known PWID.

3. People accessing community-based services depigned for males having sex

wi]h male_s, people in prostitution and those who inject drugs;
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Prevention and Control."

5. Patients showing signs and symptoms consistent with HlV-related

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diseases or AIDS seen by the attending physician.

6. Parents/ Guardian of all children born to HIV infected mothers (or those
with possible exposure)

b. Basic conditions on confidentiality, informed consent, and counseling shall be

adhered to.

c. Pre-HIV test counseling shall be limited to basic information-giving that would

help the patient decide whether to accept HIV testing (See Annex I).

d. Post-HIV test counseling services shall be provided to all clients tested by trained
'personnel (See Annex III).

e. Counselors providing post test counseling seryices shall emphasize prevention for
those that tested negative and, medical and psychosocial support to those that
tested positive.

f. The capacities for pte and post HIV test counseling including the capacity to
provide medical and psychosocial support shall be enhanced and the referral
networks between and among these providers shall be functional.

2. Conduct of HIV Testing

Only registered medical technologist with HIV proficiency training shall perform the
HIV test using Food and Drug Administration (FDA) registered test kits. Other screening
tests may be performed including but not limited to Enzyme Immunoassay (EIA), Particle
Agglutination (PA) and Rapid A,ssay (RA). Reactive samples from clientVpatients shall be
brought to the STD/AIDS Central Cooperative Laboratory (SACCL) at the San Lazaro
Hospital for confirmatory testiirg (Refer to Annex IV for the Current HIV Diagnostic Testing
Algorithm). For reactive blood units (not person) from bloOd banks, samples shall be referred
to the Research Institute for Tropical Medicine (RITM) for confirmatory testing.

3. Release and Reporting of Test Result

,samples reactive to screening test shall not be reported directly to the client/patient. All
reactive samples shall be referred for confirmatory testing. The reference laboratories namely
SACCL and RITM shall not release the result of the confirmatory test directly to the
patient/client under any circumstance but must send the result to the referring HIV testing
facility. This is to ensure that the release of the HIV test shall be accdmpanied by post'test
rormrlfng especially if the result is positive. SACCL and RITM are required to report the
confirmed positive samples to the National Epidemiology Center (NEC).

It is the responsibility of the BSF to ensure that donors have been screened properly and
pre-donation counseling has been provided to all potential blood donors in order to prevent
 the occurrence of reactive and positive samples by eliminating those individual with high risk
behaviors. For confirmed positive blood units, tracing the donor and informing himlher of the
result is not recommended. Providing result to a free HIV test can put the blood supply at risk
as high risk individuals within the window period may avail of this free services. Information
campaign on HIV services available and stigma reduction activities will be intensified by
CHD in areas where positive blood units are identified.

4. Conduct of Post - HIV test Counseling

Post-HIV test counseling shall be provided together with the release of the test result
whether the test is negativ:e or positive. It shall be done in an enclosed space where
counseling can be done in privacy. It is recommended that the trained counselor who
i' performed the pre-test counseling shall also provide the postest counseling. Refer to Annex
itl for the list of information that should be disclosed to the clients/patiants during post'test
counseling.

5. Special Concerns on Post HIV Test Counseling: Infant Feeding

HlV-infected pregnant women shall also be given information on the risk and benefits of
exclusive breastfeedrng, exclusive replacement feeding and guidance in selecting the most
suitable option in their circumstances. (The entire spectrum of preventing mother to child
transmission of HIV is described under AO No. 2009 - 0016).

VII. REQUIREMENTS FOR AN HIV COUNSELING AND TESTING FACILITY

Human Resources
1.
a. Physician, allied medicallsocial welfare personnel trained in conducting pre-test and
post-test counseling for HIV by DOH or any of its recognized organizations
b. Registered medical technologist with training on HIV proficiency testing
2. HIV test kits :

a.
Only FDA registered test kit or other available screening test (EIA/PA/RA) shall be
used in HIV testing;
b.
For HCT facilities with no HIV testing capacity,there shall be an explicit linkage to
any DOH * accredited HIV laboratory for HIV testing
3. Space - an enclosed room or devoted section/ space where counseling can be done in
pnvacy.
4. Annual certification of satisfactory perfonnance ,in the National Extemal Quality
Assurance Programme ofNRL -SACCL or its designate.

V[I. ROLES AND RESPONSIBILITIES

1. National Center for Disease Prevention and Conti'ol

a. Advocate the setting up of HCT facilities to the local government units
. (Lcu)/hospitals/health facilities as a preventive intervention in reaching the most at
risk population.
 b. Disseminate these guidelines thru the Centers for Heath Development (CHD) to all
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facilities conducting HtrV testing.

c. Develop ,r"r"rrury-t aining .odrrl", on HIV counseling and testing in coordination
with the Health Hunan Resource Development Bureau (HHRDB).
d. Mobilize existing resources and funding support from donor agencies in order to
augment the HIV test kits and facilitate the required training of human resource at the
LGU.
e. Monitor the implementation of these policies and guidelines in coordination with the
National Center for Health Facility Development (NCHFD) and the Bureau of Health
Facilities and Services (BHFS).

2. National Center for Health Facility Development (NCIIFD)

a. Develop policies and guidelines that shali further strengthen pre-donation counseling. 6
and screening at BSF.
b. Assist the NCDPC in monitoring the implernentation of.these policies and
guidelinesespeciallythosepertainingtoHIVtestinginrelationtoblooddorration.
c. Designate and capacitate additional HIV laboratories for Confirmation Test in close
coordination with National Reference Laboratory -- STD AIDS Cooperative
Laboratory San Lazaro Hospital.

3. Bureau of Health Facilities and Services (BHFS)

a. Develop policies and guidelines that shall ensure strict compliance of all accredited
OFW clinics to the provision of pre-test and post-test counseling to all their clients as
part of licensing requirements.
b. Assist the NCDPC in monitoring the implementation of these policies and guidelines
especially those pertaining to OFW clinics.

4. Centers for Health Development

a. Provide technical assistance and support
' for the implementation of these policies
and guidelines.
b. Through its regulatory division, CHD shall monitor the implemenlation of this
guideline. It'should include in its monitoring checklist indicators pertaining to the
complianoe of this gqideline.
c. Ensure that HCT services are available in all Social Hygiene Clinics, Provincial and
DOH Hospitals.
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5. Field Implementation and Management Office
a. Monitor the implementation of this policy at the CHD leyel
b. AssistCHD in advpcating to LGU for the implernentation of the policy
6. Philippine National AIDS Council Secretariat
a. Advocate and disseminate these policies and guidelines in partrrership with NCDPC.
b. Assist DOH in the conduct of monitoring of this policy

7. Private Sector Health Facilities/OFW Clinic /y

a. Ensure that provisions of thiqpolicy are complied; I
 b. il
Conduct awareness campaign on HIV and AIDS in the workplace including the
availability of HIV counseling services either by the DOH - licensed HIV laboratory
staffand/or HIV AIDS Core Team

IX. FUNDING

The Infectious Disease Offrce of the NCDPC shall allocate budget for the
implementation of these policies and guidelines including but not limited to fund for the
augmentation of HIV test kits and funds for training. Other DOH Offices including CHD
and DOH-retained hospitals shall supp<irt financially, as part of their annual budget, the
implementation of these policies and guidelines. :

X. REPEALING CLAUSE

Provisions in previous issuances that are inconsistent and eontary to this

Administrative Order are hereby rescinded and repealed.

XI. EFFECTIVITY

This Adminisfative Order shall take effect immediately.

EI\RIQUE T. MD, FPCS, FACS

ONAO
Secretaw of Health
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Annex I. Minimum Information Provided during Pre-test Counseling
Adaptedfrom Guidance on Provider- Initiated HIV Testing and Counseling in Health Facilities, WHO -
UNATDS 2007)

i. The reasons why FIIV testing and counseling is being recommended;

ii. The clinical and prevention benefits of testing and the potential risks, such as
discrimination, abandonment or violence;
ii. The services that are available in the case of either an HlV-negative or an HIV-
positive test result, including whether antiretroviral treatment is available;
iv. The fact that the test result will be treated confidentially and will not be shared with
anyone other than heath care providers directly involved in providing services to
the patient;
v. The fact that the patient has the right to decline the test and that testing will be
performed unless the patient exercises that right;
vi. The fact that declining an HIV test will not affect the patient s access to services that
do not depend upon knowledge of HIV status;
iii. In the event of an HlV-positive test result, encouragement of disclosure to other
persons who may be at risk of exposure to HIV;
[ii. An opportunity to ask the health care provider questions;
f*. Patients should also be made aware of relevant laws in jurisdictions that mandate the
I aisclosure of HIV status to sexual and/or drug injecting partngrs.

i. Risk assessment and risk-reduction strategies

ii. Promotion and facilitation of behavior change
iii. Ways of coping positive result
iv. Exploration of potential support for family or friends

i. The risks of transmitting HIV to the infant;

ii. Measures that can be taken to reduce mother-to-child transmission, including
antiretroviral prophylaxis and infant feeding counseling;
iii. The benefits to infants of early diagnosis of HIV.
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Annex II. List of Treatment Hubs in the Philippines

A. Luzon

l. San Lazaro Hospital

2. Research Institute for Tropical Medicine
3. Philppine General Hospital
4. Ilocos Training and Regional Medical Center
5. Baguio General Hospital and Medical Center
6. Bicol Regional Training and Teaching Hospital
7. Cagayan Valley Medical Center
8. Josle b. LirrgadMemorial Regional Hospital
B. Visayas
,

l. Vicente Sotto Memorial Medical Center

2. Western Visayas Medical Center
3. Corazon Locsin Montelibano Memorial Regional Hospital

C. Nlindanao

1. Davao Medical Center

2. Zamboanga City Medical Center
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Annex III. Minimum Information Given During Post-test Counseling

(Adaptedfrom Guidance on Provider-Initiated HIV Testing and Counseling in Health Facilities, WHO -
UNATDS 2007)
Annex IV-A Current HIV Diagnostic Testing Algorithm for Adults and
Infants >l8months old
Screening Test:
Rapid or EIA

Refer to
NRL-SACCL

Sample

AIg orithm for HN Confirmatory PA + Ag-Ab EIA

Testing ilnNRL'SACCL

PA (+1
EIA (+)

Western Blot

Indeterminate

a) HIV test kits with 49% specificity is used for the first screening Process.
b) Samples that tumed out tri be non-reactive on the first screening test arc considered "sertr
negativd' and the client is given a negative test report. No further testing is required
c) Samples found serercactive by all HIV screening test will be sent to the referral laboratory
(SACCL) for confirmatory testing.
d) Serereactive samples will be tested on SACCL with 2 different test format (PA and EIA
Ag/Ab). If one or Soth of the tests on parallel examination is positive then lVestern Blot test
will be performed on the sample. If both tests are negative then a negative test rePort will be
released.
e) Samples that are positive on. Western blot will be reported as positive and those thpt are
negative will be reported as negative. If the rault is indderminac, rqed follow-up
t6frt g nay be reqaired (3,6 and 12 nmnths).If the results remain indeterminate after I
year, the porson is considered to be HIV antibody negative. The client is given a negative test
rcport
0 Client s.hould be advised to come back to the HIV counseling and testing (VCT) facility after
an estimated turn-around time.
g) The client is given HIV test report after conducting Post-test counseling.
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Annex IV-B. Current HIV Diagnostic Testing Algorithm for Infants <lSmonths old*

PCR start at
6 weeks old
(Plasma)

Report as Positive Report as Negative

Repeat PCR
> 4 weeks after
(Separate sample)
Breastfeeding?

Negative Positive

Report as Negative Repeat PCR Repeat PCR

Repeat PCR > 6 weeks after last BF > 3-6months after
> 4 weeks after (Separate sample) (Separate sample)
(Seoarate samole)

Negative Positive

Negative

Report as
Negative Report as Positive
Repeat PCR
Z 4 weeks after
(Separate sample)

Positive Negative

Report as Positive Report as Negative

HrV Infected Not HMnfected

* HIV infection among infants < lSmonths old is confirmed after2 positive results by PCR
 Annex V. Administrative Order Exempting Social Hygiene Clinics from
Securing a License to Operate a Clinical Laboratory.

Republic of the Philippines

Depertment of Health
OFFICE OF THE SECRETARY
i:.w
zlF Building l, Ser Lrzrro Compound, Rizrl Avcnue, Str. Ctrzr l0O3 Mrnih
Tnrnk Line 743-E3-Ol Direct Line: 7ll-9501; Fer: 74*1E29;74T1829; 74-1-17E6
IIRL: ltttp: i,irt lr n.tloh.gor .grh; emeil: {)rc( rr doh.gor.plr €l'.t

August 28, 2008

ADTINISTRATIVE ORDER
No. 200$ oal?- A

SUBJEGT: Amendment to Adminiatrative Order No. 2OO5 - 0027 "Rules

and Reoulations Govemino the Reoulation of HIV Testinq
Laboratoriee"
Tuberculosis (TB) is one of the most common opportunistic infections among
People Living with HIV (PLHIV). Since TB significantly contributes to the mortality of
PLHIV, one strategy identified to address this concem was to put up a TB DOTS
laboratory with HIV testing capability as exemplified in Administrative Order (AO) No.
2OO8 - OO22 "Policies and Guidelines in the Collaborative Approach of TB and HIV
Prevention and Control"-

Another major public health conoem is the Sexually Transmitted Infections (STl)
which has been showrn to increase the risk of HlV. Performance of rapid serologic
tests for HIV will enhance the availability of testing in Social Hygiene Clinics (SHC).

ln view of the above, Section V. A. 1. of AO No. 2005-0027 "Rules and

Regulations Governing the Regulation of HIV Testing Laboratories" is hereby
amended to allow TB DOTS Centers and SHC to operate an HIV testing laboratory
under the direct supervision of the National AIDS/ STI Prevention and Control
Program and the National Reftrence Laboratory - STD/ AIDS Central Cooperative
Laboratory/ San Lazaro Hospital. Furthermore, these laboratories are exempted
from securing a license to operate a clinical laboratory, provided sbict adherence to
program policies and participation in their respective Quality Assurance Programs
are observed

This Order shall take effect immediately.

FRANCI T.D E lll, t.D., ilsc

of Health