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The National
HIV and AIDS Registry
Manual of Operations
~I
01321
H7.45 N385 2006/ The National HIV and AIDS registry
Foreword
The Department of Health established the National HIV and AIDS Registry in
1987. Since then reported HIV positive cases surged to more than 2,000.
Through all these years, the National Epidemiology Center has been steadfast in
monitoring the country's HIV cases. Reports published every month serve as a
guide in designing effective interventions by program managers.
Submission of reports entails an organized process which involves key players in
HIV and AIDS: the NEC, SACCL, San Lazaro Hospital, RITM, the NVBSP, the
Philippine National Red Cross, Philippine Blood Center, HIV testing laboratories,
NASPCP, DOLE, POEA, OWWA and even the HIV and AIDS Core Team in the
hospitals. This Manual of Operations for the National HIV and AIDS Registry is
carefully written and intended for all health workers dedicated to controlling and
conquering HIV and AIDS. This also contains all the legal mandates related to
the HIV and AIDS Registry.
I wish to acknowledge the committed efforts of the National Epidemiology Center
in bringing quality data necessary for action. I thank all the contributors in this
Manual who helped in identifying gaps in the reporting system and provided
recommendations for improvement. I am also grateful to our International
Partners: the WHO, UNICEF and UNAIDS, who have constantly shared the
vision of the Department of Health.
The Philippines still enjoys a low-level prevalence of HIV and AIDS. But we
should not remain complacent. This Manual of Operations features a detailed
process to follow from the time a client comes in a clinic for testing, the need for
pre- and post-test counseling and the apt referral to a treatment center or
physician for treatment, care and support. With this Manual we aim to set the
standards in bringing an effective continuum of services for all HIV and AIDS
patients.
ACKNOWLEDGEMENT
The Technical Working Group
Aura C. Corpuz, MD, PHSAE, MPH
Dorothy May Agdamag, MD, MSc
Rontgene Solante, MD, FPCP, FPSMID
Rosario Jessica Tactacan-Abrenica, MD, MPH, FPSVI
Rossana Ditangco, MD, FPCP, FPSMID
Jose Gerard Belimac, MD
Allan Ignacio
ACKNOWLDEGEMENT
Other Contributors
Ricardo Mateo, MD, PHSAE
Guada Villanueva, MD, FPOGS
Janice Campos-Caoli, MD, FPSMID
Elizabeth Telan, MD
Dr. Rolando Villote, MD
Lina Roxas, MPH
Adelfa Espantaleon, RMT
Joseph Cario Sangco, RMT
Felicitas Marlano
Corazon Orlizo
UNICEF
UNAIDS
WHO-Country Office
WHO-WPRO
The Secretariat
Fe Sinson, MA in Math
lea Mylene Rebanal
Joel Jacob
The National Epidemiology Center (NEC) wishes to give special thanks to UNICEF,
WHO and UNAIDS for their technical support and generous contribution to the
development of this manual. NEC also acknowledges FETPAFI for rendering its
technical expertise and administrative assistance in this endeavor. Finally, NEC extends
its gratitude to the clients of Physician's Diagnostic who voluntarily participated in the
pre-testing of the new HIV Registry forms, to all the accredited HIV testing centers in
Cebu, Davao, Manila, Pasayand Quezon Cities and their respective CHDs (C. Visayas,
S. Mindanao and NCR) for their unsolicited support dUring the pilot testing of the
protocol.
TABLE OF CONTENTS
I.
07
II.
Data Collection
How the HIV/AIDS Registry Works
The HIV/AIDS Registry Forms
DOH-NEC Form A
DOH-NEC Form B
09
III.
........................................................... 18
IV.
Blood Donors
V.
VI.
Laboratory Section
VII.
VIII.
Addendum
ANNEXES
15
22
.................................................. 26
30
........................................................... 31
............................................................................. 32
ABBREVIATIONS
AIDS
AMCOW
ARV
BHFS
BSF
CHD
DOH
DOLE-OSHC
EQAS
HACT
HIV
NASPCP
NCDPC
NEC
NHSSS
NRL
NVBSP
OFW
01
OWWA
PA
PBC
PDOS
PEOS
PMTCT
PNAC
PNRC
POEA
RITM
SACCL
SLH
STI
rns
UNAIDS
UNICEF
VCCT
VNRBD
WB
WHO
WHO-WPRO
I.
Historical Background:
When the first AIDS case was reported in the Philippines in 1984, the
Department of Health declared HIV/AIDS a notifiable disease in 1986. The
following year, the HIV/AIDS Registry was institutionalized in the Department of
Health under the Health Intelligence Service Office. The goals of the Registry
were to log all confirmed HIV positive cases, analyze their profile and monitor the
progression of the disease.
However, the system encountered limitations namely the delayed reporting
and under reporting. To address this gap, the National HIV/AIDS Sentinel
Surveillance System (NHSSS) was established in the same office of the
Department of Health in 1993, under the AIDS Surveillance and Education
Project (ASEP) of the USAID with technical support from the World Health
Organization. The NHSSS initiated the active serologic surveillance, to serve as
warning signal of an impending HIV epidemic. To complement the serologic
surveillance, another active surveillance, the behavioral surveillance system was
established in 1997 to monitor the behavior that put people at risk for HIV.
The passage of Republic Act 8504 otherwise known as the Philippine
AIDS Prevention and Control Act of 1998 ushered in the establishment of a
comprehensive HIV/AIDS monitoring program or AIDSWATCH in the Department
of Health. Upon the effectivity of the Implementing Rules and Regulations (IRR)
of RA 8504, AIDSWATCH integrated unto itself the NHSSS and the AIDS
Registry (section 38, rule 6, IRR, RA 8504).
In 2000, with the reorganization of the Department of Health, the Health
Intelligence Service (HIS) and the Field Epidemiology Training Program (FETP)
were lumped into one Center, the National Epidemiology Center. The Center
gave birth to three divisions: Applied Public Health where FETP lodges, the
Public Health Surveillance and the Surveys, Risk Assessment and Evaluation,
where the AIDSWATCH lodges.
AIDSWATCH
II.
Data Collection
Filipinos who are applying for work abroad are referred by their respective
recruiting or manning agencies to accredited OFW clinics for medical clearance.
History taking and physical examination are done prior to blood extraction. In
countries where HIV antibody testing are required, he or she undergoes pre-test
counseling, signs a written informed consent and fills out the NEC-DOH Form A
(Personal Information Sheet) [ANNEX OJ.
Blood Extraction
The person proceeds to the blood extraction room for HIV antibody testing.
The HIV proficient medical technologist checks the completeness of the NECDOH Form A and signs the written informed consent. He or she shall see to it
that the written informed consent has also been signed by the person prior to
affixing his/her signature. The pathologist on duty shall also countersign the
consent.
The medical technologist will enter the person's code in a logbook and
assigns a laboratory code. He or she shall label the test tube with the said
laboratory code. Upon extraction, advice will be given regarding the date of return
for the result. A result claim card or receipt will be given to the person, whose
blood was extracted, indicating the date of extraction, the laboratory code, and
the date of return and the name of the medical technologist. The person will then
be advised to present the result claim card or receipt on the date of return
specified.
Release of Result
Release of result of HIV/AIDS testing shall be confidential. Upon
confirmation by the NRL, result will be sealed in an envelope and released
accordingly:
a.
b.
c.
d.
e.
10
r
Post Test Counseling. Treatment, Care and Support
Post test support and services are crucial. The results of HIV testing
should always be offered to the person being tested, along with appropriate posttest information, counseling, and referral to care, support and treatment.
If the referring hospital has a HIV/AIDS Gore Team (HAGT) [ANNEX GJ,
post test counseling will be done by any member of HAGT and assessment of
patient will be done by the medical doctor. HAGT ensures that proper
management will be given to the patient. The NEG-DOH Form B will be filled out
and signed by the physician and sent to NEG within five working days upon
receipt of the result.
If the referring hospital, clinic, laboratory has no HAGT, any trained
counselor on HIV/AIDS shall do the post test counseling and the in-house
medical doctor qualified to do the assessment of HIV patient shall do the initial
assessment and fills out the NEG-DOH Form B. The referring hospital, clinic,
laboratory is responsible to submit the completed and signed NEG-DOH Form B
to NEG. The hospital, clinic, laboratory or medical doctor shall then ensure that
the patient is referred to treatment hub for clinical management and psychosocial support (ANNEX H).
11
Fig. 1
Walk-in request!
consultationl
referral
Fills out Personal
Information Sheet
(DOH-NEC Form A)
Disagree
r-------,
Advise to
come back
if with risk
factors
Refer to VCCT)-----oi
Refer to attending
physician or HACT for
Post-test counseling &
Physician's assessment
Agree
Screening
Yes
Yes
Yes
Positive
Test?
Confirmation
No
-'
Release result to
attending physician or
"**HACT for post test
counseling of diem
Submits to HIV Registry when there Is follow up, conversion to AIDS or death
--HACT-HIVIAIDS Core Team
No
Sends Personal
Information sheet
wi Confirmatory
Result to NEC
HIV
Registry
Reactive/Indeterminate Result
A copy of the DOH-NEC Form A will accompany the NRL referral form and
specimen in sending the latter to the NRL for confirmation.
13
Follow-Up
Should there be changes in the patient's record like placing him/her on
ARV/prophylaxis/PMTCT (for pregnant women), a follow-up report should be
done to NEC. A new DOH-NEC Form B has to be filled out and sent to NEC
within five working days upon assessment.
14
III.
Client initiated
Provider initiated
15
Counseling is recommended:
By a trained counselor
In a place conducive for counseling
Emphasis on confidentiality
All hospital personnel with whom the patient may interact for the conduct
of HIV testing (social worker, laboratory personnel, billing and cashier
personnel) should act professionally to ensure confidentiality of the test.
Release of Reactive Result
1. Results should only be released to the client as described in the RA
8504
2. Cross-check clients 10, blood samples and records
3. Clients should be the one to open the results
4. Post-test counseling should be provided to the client with reactive
result
5. For non-reactive results, post-test counseling should consider behavior
change modification and window period implication
6. Serum samples reactive to HIV are automatically sent to the SACCL
for confirmatory testing
For HIV Ab seropositive individuals, intensive post-test counseling should
be done by the counselor and referral to appropriate services if indicated
(Treatment hubs, Support Network) should be emphasized.
B. Referred Patients
a. Asymptomatic but HIV status unknown
i. Patients referred to HACT for evaluation and assessment for
possible HIV infection shall be offered with VCT services.
He/she will undergo the same process described in section A.
b. Symptomatic but HIV status unknown
i. Clinical symptoms of patients referred to HACT for
evaluation and assessment for possible HIV infection shall
be addressed first before offering VCT services. If clinical
symptoms are already addressed, the referred clients will
undergo the same process described in section A.
16
i.
17
IV.
Blood Donor
Blood safety is one of the priority issues for prevention of HIV/AIDS. World
Health Assembly 45.35 states that there should be improved measures for the
prevention of HIV due to blood and blood products: by promoting transfusion
services that provide for the screening of all blood donations, counseling and
guidance and other preventive elements.
As a global health policy for blood safety in any country, the World Health
Organization (WHO) requires voluntary blood donation to prevent Transfusion
Transmitted Infections (Dis) to ensure the provision of adequate safe blood in
the country.
The voluntary non-remunerated blood donor (VNRBD) fills out the Donor
Data sheet as a self-screening tool for risk factors. The donor may self defer
based on this. If the donor finds no reason for self-deferral he would undergo
Donor screening by qualified blood bank staff. The donor must be assured that
information concerning his medical and social history shall be treated as highly
confidential and shall not be discussed even with his relatives and friends. Donor
interview and physical examination must be done in an area, which ensures
visual and auditory privacy. The importance and epidemiological significance of
donor recall shall be emphasized, ensuring that it will not discourage future blood
donations.
If risk factors are present blood donation shall be deferred. If one of these
factors is HIV/AIDS related, the blood donor shall be referred to VCCT. In the
absence of these risk factors the blood donor shall be advised that in the event
18
that the donated blood is found positive for TTls, especially HIV, he shall be
recalled for repeat testing, confirmatory tests, and referral if necessary.
If the donor qualifies, he/she must sign a donor medical declaration form,
which is witnessed and signed by the interviewer. This medical declaration form
shall include consent for HIV Testing and recall.
Donor recall
19
The physician fills out the Physicians HIV case reporting form (DOH-NEG
Form B) and submits to NEG together with the DOH-NEG Form A and
confirmatory test result within five working days upon receipt of the confirmatory
test result.
20
Walk-In
Donor
p",.
donation
Information
Risk
Factors
Present
Donor Recall
Prevention
Reinforced
IV
Refer 10 -VCCT
Fills out
Personal
Information
Sheel & refer
lo-HACT
No
Sends
Confirmatory
Result to referring
Blood
Donation &
Screening
Refer to
HACT for
Post-test
counseling &
Physician's
Assessment
-Fills out
Physician's
HIVCase
Reporting
Form and
SUbmits to
-NEC
Yes
-BSF
Post-donatlon
Counseling
~-"---
Yes
Yes
Reactive
Confirmation
Positive?
Submits Donor Interview
Sheet and Confirmatory
Submits -RITM
Referral form 10 RITM
No
Care.
Support &
Treatment
HIV
Registry
Resurt
(Blood Unit Infonnatton)
Release result
to referring
Enters pool of
healthy donors
BSF
"Refer to NEG when there is fo(low up, conversion to AIDS or death -*RITM-Research Institute for Tropical Medicine --*HACT HIV/AIDS Core Team
-VCCT-Voluntary Confidential Counseling & Testing
V.
HIV Testing and counseling services are a gateway to HIV prevention, care
and treatment. The benefits of knowledge of HIV status can be seen at the
individual, community and population levels. They include the following:
22
confidential
be accompanied by counseling and
only be accompanied with informed consent, meaning that it is both
informed and voluntary
In many low and middle income countries, the primary model for HIV testing has
been the provision of client-initiated voluntary counseling and testing services.
Increasing, provider-initiated approaches in clinical settings are being promoted,
i.e., health care providers routinely initiating an offer of HIV testing and
counseling in which the provision of, or referral to, effective prevention and
treatment services is assured.
23
24
25
VI.
LABORATORY SECTION
It
Nonreactive
Re~ort
Inconclusive/Gray zone/Reactive
Repeat in duptcate or use another test format
~-
J+
Retort
(SACCL-patient; RITM-blood
Units)
26
Confirmatory testing
--..
EIA Ag-Ab/Rapid(PA)
Both NR
..
Discordant
Reiortas
Negative to anti-HIV
.>
-.
WB/IFAlLIA
/~~
Report
Indeterminate
Negative (repeat after 3-6mos)
to anti-HIV
27
Report
Positive
to antiHIV
(- )
(+)
(+)
(+)
Action of
referring
laboratory
Release as
neqative
Re-test;
Refer
Re-test;
Refer
Re-test;
Refer
SACCL Result
Test 1
Test 2
(EIAAa/Ab (RaDid/PAI
(+)
(+)
(+)
(-)
(-)
(-)
Confirmatory
Test Result
(WB/IFA)
100%
(+)
Indeterminat
e,
Neqative
Negative
100% (-)
Interpretati
on
(+)
Indeterminate or
Neqative
Negative
Based on these findings by SACCL, the rate of false positive results are
50%-60% (private laboratories) and 30%-40% (government laboratories). It must
be noted that an average referral from HIV testing laboratories is around 500 per
year. Analysis of the cost by SACCL showed that if all referred reactive samples
will be confirmed, the Department of Health will be spending around P1.75M
against PO.85M per year if two negative screening tests (repeat screening by
SACCL) will no longer be confirmed.
so"
28
Legal Mandates
~
RA 7179 - All blood products must be tested for TTl including HIV
29
VII.
A.O. 55-A s. 1989 dated 02 January 1989 Section B (ANNEX LJ and A.O. 20050027 dated 15 August 2005 Section V. No. 4- sub-sections a-d (ANNEX I)
Each HIV testing laboratory shall report monthly the number of tests done,
results and referrals of seroreactive samples in accordance with the format
prescribed by the BRL-DOH. This report shall be accompanied by copies of
invoices and purchase of HIV kits the previous month.
30
VIII.
Addendum
Role ofOWWA
OWWA encourages PDOS providers/trainors to strictly follow PDOS
standardized module. It also intensifies discussion of HIV/AIDS prevention in the
Personal Health Care module of PDOS for OFWs and encourages returning
OFWs to undergo voluntary counseling and testing.
31
Chemical Poisoning
Indudes chemical and pestldde poisonings that are diagnosed with laboratory support
Appendix B
Depertment of Health
National Epidemiology center
San Lazaro Compound SIa. Cruz Manila
Tel. No. 742-39-45 Telefax: 743-60-76 Emall:nh18s0m9lro.n9l.ohor nsc_dohOyaboO.com
Patlanfs Code:
Addre88:
Nationality:
Lab. Code:
-..,.
_
Bll1bdate'
Age:
_
Sex: _ _ CivilStatus..,..-Oocupatlon: _ - - - - - - - - - -
ClasslflcsUon:
Puroo..
( 1Yes If ves:
When
Result
() HIY ( ) AIDS
Mode of Transmlnloo'
Sexual Intercourse:
( ) Heterosexual
( ) Homosexual
( ) Bisexual
Annex A
Department Circular No. 176 s. 2001
33
Annex B
Department Circular No. 224 s. 2004
34
..
1-,
~luljju,~ 1. Sao Lataro Compound, Rlzlll Avenue, Slit CiUl, Manila 1003
T.I. ~,,",, 14J.8l01 locals 1125, 1132. Fax ',32) 1431829,7431785, Dlla1 711.95Q2, 711,,~03
(J:>et@l:k~l
gailph
31 May 2004
DEPARTMENT CIRCULAR
No. JJ4
.s, 2004
TO:
SUBJECT:
Emphasizing
the
Monitoring' System . and
Clarifying the Roles of the STO/AIOS Cooperative
Central Laboratory (SACCL) and the Research
Institute for Tropical Medicine (RITM) in
Confirmatory Testing for HIV/AIOS in the
Philippines
This issuance serves to clarify the monitoring system for HIV/AIDS and the roles
the confirmatory laboratories. play with regards HIV/AIDS testing within this
system.
Pursuant to Article V, Sections 27 and 28 of Republic Act {RA), Number 8504,
otherwise known as "Philippine AIDS Prevention and Control Act of 1998", the
National Epidemiology Center (NEC) of the Department of Health (DOH) shall
serve as AIDSWATCH or the Comprehensive HIV/AIDS Monitoring Program
'mandated to determine and monitor the magnitude and progression of HIV
infection in the country. In pursuit of this, a standardized Case Reporting FOJm
shall be disseminated to concerned institutions for completion upon identification
of HIV-positive individuals on screening (Annex A).
In relation to this, in the 1998 Implementing Rules and Regulations of RA 8504,
the Research Institute of Tropical Medicine (RITM) was mandated to perform
all confirmatory tests related to HIV. In 2001, by virtue of Department Circular
No. 176 s 2001, the mentioned mandate for RITM was modified, In the said
Department Circular, blood specimens reactive to HIV screening tests should be
No.
IT b s 2001
TO:
SU6JECT:
ReportabJ~Diseases
Pursuant to section 3 Act 3S73 otherwise known as the Law of Reporting of Communicable
Diseases, the list of notifiable diseases In the Philippines specified In Department Circular No.
325 - 6 s 1997 dated December 4, 1997 is hereby revised to indude the following:
Notifiable Diseases
A22
Anthrax
Cholera
Diphtheria
Viral Encephalitis
Viral Hepatitis
Leprosy
Leptospirosis
Malaria
Measles
Viral Meningitis
Neonatal Tetanus
Non-neonatal Tetanus
Meningococcal Infection
Paralytic Shellfish Poisoning
Rabies
Typhoid and paratyphoid fever
Whooping cough (Pertussis)
AOO
A36
A83-86
615-17
AJO
A27
650-54
605
A87
A33
AJ5
AJ9
T61.2
A82
A01
AJ7
These diseases have been selected due to their tendency to occur in epidemic
proportion, are targeted for eradication or elimination, or subject to international health
regulation.
Signed
De-
Received in the/REcords
~ )/01
f I
Section on
Because of the changing pattern of Infectious d1sease threats and the possibility of new
emerging and re-emergln~ diseases, unusual occurrences of the following syndromes should
alSo be reported:
DAL:/I.Vl'
UfL ..
Secretary of Health
Appendix A
Case Definitions of Notifiable Diseases
Anthru:
(A22)
".
'
An Illness with acute onset characterized by several dlnlcal forms. These are:
(a) locallzedform:
CUtaneous: skin lesion evolving over 1 to 6 days from papular through a
vesicular stage, to a depressed black eschar Invariably accompanied by edema .
that may be mild to extensive
(b) systemic forms:
gastro-lntestfnal: abdominal distress characterized by naLJliea, vomltlng, anorexia
and followed by fever
.
pulmonary (Inhalation) briefprodrome resembling acute viral respiratory Illness,
followed by rapid onset of hypoxia, dyspnea and high temperature, with x-ray
evidence of mediastinal widening
menIngeal: acute onset of high fever possibly with convulsiOns, loss of
COftSdousness, meningeal signs and symptoms; commonly noted In all systemic
Infectlons
Chollll'll (AOO)
Acute watery diarrhea and lsolatlon of VlbrfQ cholerae from stool or rectal swab
culture
Diphtheria (A36)
An Illness of the upper respiratory tract characterized by laryngltls or pharyngitis or
tonslllltls, andadherent membranes of tonsils, pharynx and/or nose
Viral Encephalitis (A83-86)
Inflammatlon of the brain which manifests as mild disease with headache and a general
malaise and muscle ache similar to that associated with Influenza. The more acute and ser10us
symptoms may Indude fever, delirium, convulsions, and coma.
Viral Hepatltl. (115-19)
Acute Illness characterized by fever, jaundice, dark urine, anorexia, malaise,
and extreme fatigue, right upper quadrant tenderness. This Indudes all kinds of
Hepatltls diagnosed dlnlcally with or without laboratory support
LeproIy (A30)
A person showing one or more of the following features, and who as yet has to .
complete a full course of treatment:
hypoplgmented or reddish skin lesions with definite loss of sensation
Involvement of the peripheral nerves as demonstrated by definite thickening with
loss of sensation
skin smear positive for add fast badlll
l.eptDspll'Oll. (A:27)
Acute febrile Illness with headache, myalgia (especially of calfmuscles) and prostration
associated with any of the following symptoms:
.
conjunctival suffuslon
meningeal Irritation
anuria or oligUria and/or proteinuria
. jaundice
.
. hemorrhages (from the Intestines; lung bleeding Isnotorious In some areas)
cardiac arrhythmia or failure
skin rash
and a hlsllory of exposure to Infected animals or an environment contaminated with
animal urine (e.g. wading Inflood waters)
Malaria (850-54)
Fever, chills, headache plus isolation of malorial parasites In the blood
Measlet(BOS)
SUspect: Fever of at least three days duration with maculopapular rash and any of the
following: cough, coryza, or conjunctivitis
Confirmed: A suspect case positive for measles 19M antibody or suspect case with
epidemiologic linkage to an 19M antibody positive case
VIral Menlngltl. (AS7)
SSESS Installation CD
Step I: Insert the installer Disk in to CD Drive..
Step 2: On the taskbar click START> RUN).
Step 3: Browse CD Drive
Step 4: Double-Click on the file SETUP.EXE.
Step 5: Follow on screen instructions.
Using HIV/AIDS software
After installation, a HIVAIDS shortcut icon will appear on your desktop. Click on the
shortcut to start program or the program can be started by selecting
'Start>Programs>HIVAIDS Registry'. Click on either to start the program.
"if- - - -
ij) - - -
11-....
.--
l1i - - - -
lllI"""......""
'" .........""""
lllI ~,...,.
lllI ,...,.-
~-
t:lI -
~_
"*""
ij)_
fusion Pt.
i:ll-........_
~
"".5
ij) .........
ij)"
HlVAJDS Re9StJY
lllI
....
e.-
0--
i:ll-
~_OfflooT'"
~ Maosdt *-Istulo 6.0
..
~--
~ ~5ettrIQI
~--_.
Tr
lllI .....-
AJJf'H..qrJf),~
.,
1: start
.'
_ _ .o
.......-
ij)
ij)<:S'lo'..
~ <:S'lo 2.5
i:ll <:S'lo 3~
~-"'*"
ll!Ii!D 5lIIrt1l
iill"ll!I .....
37
~-I!I """
Ill! """'"
II fIIcro5IDft Pc:Jwer9l:*'t
1 1 -........
i1--
,,'
DATA ENTRY
The main HIVAIDS screen will appear and the menu choices are available on top of the
screen
Step 1: Click
Data Entry Menu
Step 2: Click
PIS Data Entry
38
Step 3: Data Entry Screen for Personal Information Record will appear.
Hi
~tH8
Recolve!Source of Information
Truvol History
Date of Reglsb'atlOn
II
If fOr E""loyment
If Other Please Specify
FrstName
M.I.
LaatName
..-....s,
RegIOn
:::::J
Provnce
Contact No.
sex,
BO'1hday
:::::J
,.",rnber Oliidren
CMIStatu9
39
Sexual Encounters
EmploymBnt History
Source o1lnlDnnation
T'BVeI History
PatientCode 1123a
P\IpOS8ofT"b1g
Ifftr
E"""'
''''
0hIr
If
1 " " 1- - - - - - . . ,
Pease Specify
.---IlIi
- _.... 1 - - FntName
MI.
::1
Note: After you entered the patient code the computer will check if the patient code
already exist and will advice the user for any possible duplication, then the system will
automatically fill up the rest of the fields. If patient code does not exist on the database,
the entry fields will remain blank.
40
Step 6: After doing all data entry on the Personal Information Screen, Click Save button
to add the patient to the database. After saving, click the physician button to start
entering the physician case reporting data of patient.
,,"i~;'~"'~'---:--
~-~~'~"'~$
.. I>hysu:ian'sIIiV/AIl)S C<1S(!
txl
I~cporlmr.
Data Vbut
Type of
Ifllea1ll. Data
Lalxra'....."""",.....---;:,.---,-------'
Mon1ll
I
NewAecxwd
QUI
Report Menu
Step I Click on
report menu after
clicking 3 sub
menu will appear
41
3 Sub Menus
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42
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I:llV/tJ~S, ~.nU8!l' 1984 October 2IXIi
CONTACT
~ '!ET!'BQSEXUAl.
HOMOSEXUAl.
CONTACT
r-l,BISEXUAL CoNTACT
~
9 BLOODIBt..OOi:l PRODUCTS
iNJECTING DRUG USEfT, NEEDLE PRIci<INJURIES
PERIN.6JAI. 13 NO EXPOSURE REPORTED
:! Mol
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23
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BV Gender
3
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. Oct. 2006
0-01
2-04
5-14
15-19
20-39
40-49
>50
121 080604020020406081 12
Male
Ferral.
0-01
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HIV/AIDS Registry .
Information System
36
Hospitals. Clinics,
Laboratories
Blood Banks
Case Reporting
- - Form of WesternBlot Confirmed
HIVCases
Physicians
NeonatlllTetanUi (A33)
:~ . :
OC:curence of the following symptDms Ina nonnal newborn within the J'" to 28111 day
post partum:
Inability to suck
generalized muscle spasm (stiffness)
convulsions and
r1sus sardonlcus
SUdden onset of fever and any of.the following: neck stiffness, altered consciousness,
other meningeal signs, petechial or purpural rash, gram negative cocci on gram stain of
CSF or skin saaplngs and without apparent cause.
bbl. (A82)
SYNDROMES:
Aeut8Placdd PlI'lIIyIII (APP)
'~,
Sudden onset of flaccid ("fIoppyj paralysisIn a child below 15years old Indudlng those
diagnosed to have Gulllain Barre Syndrome for which noother cause could be Identlfled
Acute onset of fever of less than 3 weeks duration In a severely III patient and any 2 cif
the following
hemorrhagic or purpuric rash
epistaxis
hematernesls
hemoptysis
blood Instools
Acute watery diarrhea (passage of 3 or more loose watery stools In the past 24
hours) with or without dehydration
r
Republic ofthe Philippines
DeparbnentofHeatth
BUREAU OF HEALTH FACILITIES AND SERVICES
Manila
LIST OF ACCREDITED HIV TESTING
LABORATORIES
As of December 31, 2005
ADDRESS
NAME
AVS MEDICAL CLINIC, INC. 2JF.1214 ....."" T"dl c.."It,....."" St., Enn"" Mil
BIO-LAB MEDICAL SYSTEMS, INC. CLINICAL LAB. 8103 VA RuBno 8U.Ig.IlpiVIlIagl, M_
BIOMED DIAGNOSTIC & HEALTHCARE CTR, INC.
BIOMEDIX, INC., MEDICAL LABORATORY 82015 Modica! P~u Bldg., Ortlgll, SanMlg",'A......g
BIOSCAN CLINICAL lABORATORY Unit g J TlOlIoro St.,.... A..n." G.... Plrk, Col. CIty
CALPE MEDICAL CLINIC 81421 A.llablnl SL, Enn""
Monl~
CLINICAL OCCUPATIONAL MED. & TREATMENT CTR.,INC. ..70 San An.... c. U.H. Dol PUar51., U.,..., U",~
CLlNILAB MEDICAL SERVICES, INC. 7JF .2303 Bid;., Chin. R_ Ell!., U.kaII City
CLlNIMEO BIODIAGNOSTIC CENTER W4GoC P.1m Court,PC
CUNJTECH DIAGNOSTICS Unit 4,Parlan Commerdal Center, Common.earth Ave., Q.c.
CO MEDICAL & DIAGNOSTIC' CLINIC 8011I101 Uulm BIdg.,G UlllnO"'"y St., BllIon", Monl~
DE LOS SANTOS MEDICAL CENTER 1201 E. RodrlOu" SLA"AC
DEPT. OF PATHOLOGY VETERANS MEM. MED. CTR. Nortll Avo., Dlllm", C.C.
DONICA DIAGNOSTIC AND IMAGING SERVICES .12ADr. A. San... Ave., P.""",u. City
DR. FE DEL MUNDO MEDICAL CTR. FOUND. PHILS.INC BonlUl S1, CC
DR. JESUS C. DELGADO MEM. HOSP. 17Klmunlllo Rd., CC.
DR. JOSE FABELLA MEM. HOSP. Lopod. VOO', SII. Crvz, UII.
DR. JOSE N. RODRIGUEZ MEMORIAL HOSPITAL T.,.,CoJoocan City
DR. VICTOR R. POTENCIANO MED. CTR. 1163 EDSA, U"doIuyonO City
EASTERN DOCTORS CUNIC
EBN SIMA MEDICAL DIAGNOSTIC
E.C. TORRES MEDICAL CLINIC Rm. 320 C.1t Sy ~mond BIdO., PlllY CIty
EAST AVENUE MEDICAL CENTER eoltAv"C.C.
ECHAVEZ MEDICAL SERVICES
Arl. SqUill
EL ROI MEDICAL CLINIC & DIAGNOSTIC CTR. INC. ..... 5dl St., Klmunlno, Qu"on City
FAR EASTERN POLYCLINIC I6BO J."n Condo, S.... Blvd., cor SImIt St, Uondo
FATIMA MEDICAL CENTER 120 IIcArUn.!f Highway, 1111111 , Valenzuela City
DlhU.Cor.Rooo~d.Avo.
WlltF.hvlow,CC
FIRST MULTI HEALTHCARE SERVICES T.ft Avo. c. Qulrln. Avo., Mo~.. , U~.
FMT HEALTHCARE SPECIALIST GROUP
GAlENUS CLINIC, INC. 3F F'rvuIOn Pm Tow,', ".H.de1 Pilar, Ermlta, Mia.
GEN MEO HEAlTH SERVICES 40Cuevas Tower, raftAn.,cor. P. Gil St.,M.llte, Mia
GOOD HEALTH DIAGNOSTIC CENTER Gen. M.lvaf Avenue, Ataneta Center, Cubao, a.c.
HEALTHLAB,INC.
HEALTH POINT MEDICAL CLINICS & DIAG. CTR. 5T7 P.... FIUII St., Emili, UI,
HEALTHWAY MEDICAL CLINICS 2F Ay.l. Ufo BldO., 16788 Ay.l. Avonuo, U.kaII City
HEALTHWAY MEDICAL LABORATORY
HEARTLAND MEDICAL & DIAGNOSTIC CENTER 11585 Gon. Luoo 51., P.co, Usnll.
HOLY ANGEL MEDICAL CLINIC, INC.
HOPE LOVE FAITH MEDICAL CLINIC & LAB. 35-<: Quozon Av"uo C. Cordill", St., Cuo... City
HOSPITAL OF THE INFANT JESUS 1558 L.onOI.on St. S.mpoloc, Yonll.
INTERNATIONAL DIAGNOSTIC CENTER. INC. IDCl BldO., RImed... 51., MolIlI, Uon",
IPPOKRATIS DIAGNOSTIC SERVICES CTR.,INC,
J/J MEDiCAl & INDUSTRIAL CLINIC t2001
CUIVII
JABEZ MEDICAl DIAGNOSTIC eTR., INC. Rm. 305 Boo Bldg., 202 E.RodDoulZ Sr, Avo., Q.C.
JOSE L GlITlERREZ CLINIC & CLINICAl LAB.
JOSE R. REYES MEMORIAl MEDICAl CENTER RIul AVL, StL Cna, M~.
KING OF KINGS LABORATORY & DIAGNOSTIC CTR. I4O-A V. Luna Road, Qu.... CIty
LABSTAT DIAGNOSTICS & DRUG SCREENING LAB.
LAKAMBINI DIAGNOSTIC CENTER '1991 Unit E& FWardlly B1dg., Taft AnnUl, PIIIY
ely
LAS ptAAs CITY MEDiCAl CENTER, INC. 1314 M..... A1vIlWZ Avo., Talon I,La. Pl... CIty
LAS PIAAs DISTRICT HOSPITAl PulanO Lup., La. PUl.. CIty
lAS PIAAs DOCTORS HOSP. 8009 JIAguilar AVe., Pullnglupa U, lis PlA.. CI~
UB CLINICIANS DIAGNOSTIC CENTER cor. Edl... SI., Son.G' PuyaIAvL, M.kati CIty
Qu.... Avo.Q,C.
MARITIME CLINIC FOR INTERNATIONAl SERVICE 10F Tim.. Plaza B1do., ..,UN A
MARITIME MEDICAl & LAB. INC. 1531 2f Pa..gon Towar, AFI
MERITA DlAGNOSTIC. CLINIC .1990Taft Ave. cor. P.Qulrlno Ava., "alate, "'nO,
METROMED CLINICAl LABORATORY 12m M.blnl sr, Mal"', ManU.
METROPOLITAN HOSPITAl 1357 G. Mmngka, SI., StLCruz M~.
MHYCARE DIAGNOSTIC CENTER 75-C Main AVL, Murplly, Cubao, ac.
MICAH MEDICAl CLINIC & DIAGNOSTIC LAB. '1971T.ft Avanva, M.,..., Man"
MOTHER SEATON CLINICAl LAB 11577 MaNy Man...,F. Tva... Bl,StLt.na, Manl.
MP~
MSC MEDICAl DENTAl DIAGNOSTIC SERVICES 11153 DoVIDa B1do., II.H.d.1 PDar SI.,EnnI.. ,Manll.
MT. GILEAD MEDICAL & DIAGNDSTIC SERVICES, URa Townhom..,""'ng. Zlpoto Rd., La. P~II
M-TECH MED. DIAGNOSTIC &THERAPUETIC CTR, 1379 Son. Gil Puyol Avo" Bel.AJr VBI.g., ...... City
MVR LAB, DIAGNOSTIC CENTER 11636 T'" Kola. St,Ennlto, nI~
NATIONAL CENTER FOR MENTAL HEALTH
11~2'"
NOTRE DAME MEDICAL DENTAL CLiNIC INC, 11268-1' UN Avonuo, Poco, Nonlla
OSPITAL NGMAKATI Slmpallulta cor. Dahill St, Fort Bonifacio, ... kIt! CIty
a!l'
,....
T.ftAvonuo"'~
PHiLiPPINE MEDICAL TESTS SYSTEM Rm. 203-2001 Bon-Lor Bldg., Quozon A~, Qu"on CI!l'
PHYSICIANS DIAGNOSTIC SERVICE CENTER t533 Phyoldon.' Towor, UN Avonuo, .........
PNP GENERAL HOSPITAL Comp CnIme, D.C.
PNRC QUEZON CITY CHAPTER BLOOD CENTER Now a!l' H.IICompound, Dlllmon, QC.
PRJME LABORATORY .17Gen. Urn Sl COl'. Gen. DeJesul St., San Juan, ....
PROBE POLYCLINIC & DIAGNDSTIC CENTER, INC. 3F AIlIC Bldg.
,.onlla
~:Al'/*i.~;;.1> :'2:'
s ,; . ~~.,--,---",,==~"'4
RSS cm HEALTH SERVICES 121 P"'g Blvd. ExL, Conlogon, PIIlg CIty
SAN JUAN DE DIOS EDUC, FOUND., INC. 2T72 Roxoo Blvd, P..oya!l'
SAN LAZARO HOSPITAL QuIrlCidi a, S1L CM, .
_.qu.
MM.
ST. ANDREW MEDICAl AND CLINICAl DIAG. LAB., INC. 397 J.P. RJuI 81. "".Illnokod Sl., M.WCity
ST. IGNATIUS DE LOYOLA HEAlTH CARE SERV.(Maln) 239 Shoo Avo., SIll. Millo, M.r1kIn. CIty
ST. LUKE'S MEDICAl CENTER
a.c.
THE FAMILY CLINIC AND HOSP., INC. " .." M.n. ctoro 81., SampaJce, MIL.
THE MEDICAl CITY Sin Mlgull Ave. cor. lounl.. Rd.,lIandiluyong City
ClIy. LaUnl",
IlIyombo
ILOCOS TRAINING AND REGIONAL MEDICAL CTR CIty ofSan Fe........ LaUnIOn
LAUNION MEDICAL DIAGNOSTIC CENTER & HOSP _OIl St., ClIy ofSanFtmando, La Union
LORMA MEDICAL CENTER CWtan, ClIy ofS.. F......do. LaUnIOn
MARlAND MARCOS MEM. HOSP. AND MED. CTR. 1lOIIe, II_ Norto
PANGASINAN CENTER FOR FAMILY MEDICINE, INC. Amodo Sl, TIpI" DioOid, Dagup.. CUr
PANGASINAN MEDICAL CENTER
PNRC lLOCOS NORTE LAOAG CITY CHAPTER
BLDG. CTR.
N.~.
a, D.gupon City
oIn..
oIn..
M~o",
MaIol.., Bul.,,"
it
SUBIC BAY MEDICAL CENTER Cubl .oln~ Soble FIHpM Zo"" O'aog.po City
TALON GENERAL HOSPITAL F. TIOadoSt,T'Ne
TARLAC PROVINCIAL HOSPITAL Sao Vice""" Twe City
vi, MAKABAU MEM. HOSP., INC. B.Mondoza St, Sa" Ferna""City, "",,"ga
Zo"" 0I0~ C~
~cl~ CapItal,
BaJanga all
T.rIIC CIIl
CnlI~ng
Cl....ba QI.Laguna
PNRC- LAGUNA CHAPTER (new) J. deltorl St. cor. P. OUIY&m Ave., Sta. Cruz.ulIun.
QUEEN MARY HELP OF CHRISTIAN HOSPITAL CtIthln, Conl"'., RIW
SAN PABLO COLLEGES MEO. CTR. 1l'llY. Stn Rtft'L Stn P.blo ClIy
ST. OOMINIC MEDICAL CENTER Aguinaldo Hlghway, T.~bI, eacoor, Co~llI
ST. FRANCES CABRINI MEDICAL CENTER Pob. 211.h.rIIka Hlghy, &to. Toma., Batang..
ST. PATRICK'S HOSP. MED. CTR. Lopez Jain' St, BallI.... City
BICOL REGIONAL TRAINING AND TEACHING HOSP. RIW St, L....pl City
ESTEVEZ MEMORIAL HOSPITAL Dan....nS. E _ 81.. GUIVa.. Subel., Le... pl ClIy
MOTHER SETON HOSPITAL Roxu Av...Dlvlnlon, N... CIIy
REGIONAL HEALTH LAB. AND BLD. BANK NO. V Legu,l CIIy
SAN ANTONIO DIAGNOSTIC LABORATORY GIF AMVVSLAJ BId;., Rlul a, Legu,l City
ST. JOHN HOSP INC. Ptn..nlbln 81., .... ClIy
STA. MARIA JOSEFA HOSPITAL Y2005
MASBATE HOSP. & HEALTH SERVICE COOP., Y2005 IIubllll CIIy
STS. PETER & PAUL HOSPITAL Y2005
_09'"City
PNRC Y2005
o.d, Carnarln..
Nortt
DR. PABLO O. TORRE MEM. HOSP, as. Aquino 1lItY', Bacolod Cl1r
OR. V.T. TALEON MEDICAL CLINIC, X-RAY & VllCA Bldg, 1znartSt., DoIloCity
DIAGNOSTIC LAB.
ILOILO DOCTORS' HOSP., INC. Wo.. Ave., MoIo, IIoDo Cl1r
ILOILO MEDICAL CENTER CLINICAL LABORATORY Ddlo City
IMSMC DIAGNOSTIC CENTER Jarv, IIolIo aty
JAflA.CLlNICAL PATHOLOGICAL LABORATORY BacoIod aty, ..... ~ I
JARANIllA MEDICAL LABORATORY Lapaz, 110110 Cl1r
MEDICUS (ILOILO CITY) INC. BRANCH DolIo City
MEDICUS OLOILO CITY) INC. MAIN 110I10 City
MEDISENSE LABORATORY CENTER, INC. (new) Door 3AU & 80M Bldg., BuIVOl St.,Bacolod aty
PNRC- BACOLOD CITY CHAPTER lDlh La..... St, BacoIod Cl1r
PNRC BLOOO BANK LABORATORY IJalJo City
PNRC- CAPIZ CHAPTER BLD. CTR. Dlnggoy Rom "."'lC~1
Q. _
79 F. Ramos St.,CIbuCity
.. Ibn_ aty,Cebu
City
VU~
SILUMAN UNIV. MED. CTR. FOUND., INC. V. Aldoc.. Rd., ilIro, Dumogutll City
ST. PETER.pAUL MEDICAL CENTER
MAYOR H1lAR10N A RAMIRO, SR. REG. TRNG. & ."dog, Ozam~ City
TEACH.HOSP.
MEDINA GENERAL HOSPITAl. 0wnI. City
MERCY COMMUNITY HOSP., INC.
NItI",~
MMG HOSP. AND HEALTH SERVICES COOP. OF DAYAO 3nl A"., lion Gm~ SL,Dan. City
MMGH & HEAl.TH SERV. COOP. OF TAGUM
ALXIAN BROTHERS
MLS PRIME HEALTH AND DIAGNOSTIC CENTER
RICARDO UMSO MEDICAL CENTER
ORMEDIC
ST. CAMILLUS HOSPITAl.
MATI PROVINCIAl. HOSPITAl.
DIGOS DOCTORS HOSPITAl.
K.....da1 CIty
_Ion
CIty
Annex D
DOH-NEe Form A
(English and Tagalog Version)
48
confidential. Please fill out form as honestlV as possible. If below 18 year. old, or
physically/mentallV Incapacitated, the guardian I. requested to fill out this form on behalf
of the Individual/client.
t. Purpose
Personal
EmploYlnent
0
0
0
0
Local
Abroad
Legal':lnsurance
Entrance to School
No
0
0
0
0
0
Yes
Yes
Yes
Yes
No
No
No
No
c::J
I
last name
MI
First Name
permanent lIddress/malllng address:
Contilct No: _ _ _ _
6Irthd.y[M'I/DD/Y,n): --1--1_ _
No.of Children (if applicable):
Age: _ _
Sex (M/F):_
Civil Status:
Nationality:
------
Occupaucws in
If OFW
Yes
No
Tourist
0 Educatlon!Trelnlng
Buslness/Offldal
Employment
See-Based
0 land-Based
- (Please check box/a that .-;D~l-
0 No
Date:
Date:
Date:
o
o
o
o
o
0
0
0
How a person can get HIV
Services AvaUable (O:lIl1UClln;, lr"eatmentarc 6 $UpJlOIlJ 0
DYes
ONo
VIII. What are your other sources of Information on HIV I AIDS (check all that applle.)
0
0
0
0
0
0
Group Counseling
Video
Other, Please spedfy:
--~
--
--
49
--
--
_.
_._- . -
--,
HIV antibody test Is a blood test. It will show If you have antibodies to
HIY- - the virus that causes AIDS. A sample of blood will be taken from
your arm. If the first test (screening) shows a positive reaction, another
test (confirmatory) will be done to make sure that the first test Is really
positive. A positive antibody test means you have been Infected with HI\{,
a negative test means you are probably not.Infected because It takes
time for the body to produce antibodies. So If you have been exposed recently, you need to be retested after 3 6 months to make sure you are
not infected.
2. What are the benefits of taking the test?
If you test negative:
You can learn how to protect yourself from getting infected by practldng
safer sex (e.g. monogamous relationship, condom use).
If yoy test positive:
You can learn how to avoid transmitting the virus to others like your partner or unborn child and how to take good care of your health properly by
adhering to your doctor's advice. You can also seek assistance from the
Sex:
Address:
Physician
Medical Technologist
(signature over printed name)
Agency/Hosplta.l:
Date:
t.
KadahlJan.an n9 ppgpapll5url ng DU80 (Paldlauyan ng check [I) ang plnak. ongkop n'8 Algot
, ,
panSar111
Trabaho
Pillplnas
Abroad
'0
00
HIndi
00
00
HIndI
HIndI
Hindi
Hindi
0
0
I.egal/InSunlnce
PagpDsok sa Paii!lralan:
00
00
0
0
c::
Pangalan
::=J
llrahal1/Address ne pW",deng
c=J
I
Apelyldo
paopadelhan ng SUlat:=================
retepcnc: __ ~_ _.".._-=-----.,
---------
Kapilnganakan(BuwaniAraw/Taon): --1_1
Dllang ng
anak ne
HI
Kasarlan(M/F):_
ll1ababe sa Ie teen (Saguun kung I\aaangkop): __
Edad: _ _ Estttdo:
Lilhl:
patuten 09 Paglulakbay:
_L . _ . . . . . .
tUndl
_
PlJg-aaral(TllIlnlng
Trabaho
;:J. pall~: lupa
00
TUrlS\'D
Business/Official
v.
taon:
pangalan ng nspnet:
Petsa:
Pilngalan ng Klinlka
Pangalan "9 Blood Benk:
Petsa:
Hindi
Resulta(i/-): _
Resulta(+I-):
Petsll:
mil
Dilot)
VII. Mav natangvap lea bang lmporm..yon tungkal sa HIV at AIDS sa kUniQ. o&;pltal 0 laboratoryo
itol 00 0
Hindi 0
Kung 00. pakllauyan ng check [IJ BUg box na naaangkop
o
o
n.
test
VIII. Ano 0 Alln ling Ibll pIIng plnanggagallnlilan ng Ivonlillmpormuyon tufllilkDl HIV at AIDS (Iagvan ng check
oS na ngkOp na IIDClot)
U
One on One Counseling
Pre-Departure Orientation SeminaI' (POOS)
PamphletS/Posters
Address:
Name and Signature of MO:
Contact No.:
51
Group Counseling
At Iba pa:
Video
Pangalan/Alyas:
Kasarlan:
Edad:
Address:
Doktor
Medical Technologist
(Pangalan at Lagda)
4. Pagkuha n9 resulta
Aog resulta og HIV test ay mananatiling Ilhlm. AAg resulta ay ibibigay Jamang salvo 09 personal 0 sa taong blnlgyan ma "9 kapangayar1han
Agencia/Hospltal:
Petsa:
Annex E
List of Accredited HIV Testing Laboratories
53
CHD-CARAGA
BUTUAN MEDICAl CENTER Butu.. CIty
CARAGA REGIONAL HOSPITAL RlzaI St. Burigl. City
D.O. PLAZA MEM. HOSPITAL Patln...y, Prooparldad, AQuu, daI Sur
PNRCo BUTUAN CITY BLD. CTR. Capltol SI... Ag.... daJ
PNRCo SUR/GAO DEL NORTE CHAPTER (now) PI"'" eor. IlagaD
_ .. City
St. S.riga. CIty
Annex F
54
first Neme
0MI
I
Last name
Ovll Status:
Age:
0
0
0
0
Initial'
Follow-up
Conversion to AIDS
Date (MM/DD/yyyy): ...../-----.1
Death
IV.
urv/ AIDS
Laboratory Code:
V. Mode or Transmission
0
0
0
0
0
Homosexual
DYes
IX. If patient Is child < 2 years old, What is current feeding practice
0 Exclusive Breastfeeding
0 Mixed Breastfeedlng
X. If patient Is <::: 18 years old
0 On Cotrlmoxazole
0 OnARV
Started (MM/YYVY) :
Started (MM/YYVY) :
[n.
Physicians Name:
Contact Number:
Health FadIJty(Narne/Address) :
Dote Report (MM/DD/YYVY): -----.1-----.1
55
Yes
No
No
WHO Classification
Indicate in the columns below what disease(s) the patients has by placing a ring around the bullet point next to the disease or clinical problem
Lymphoma
Kaposi'S sarcoma
HJV encephalopathy'
Annex G
Administrative Order No. 18 s. 1995
57
.SAN:i?~:tARO:COMPOUNO'':
RIZAl:AVeNve;STA. CRUZ
MANILA,:p!liLIPPINeS :: .....
reqlO. 7\ i -00'80 .
21 November 199.5
AD.l\w;tISTRATIVE ORDER
s, 1995
.
.
NO~.Ltr_
SUBJEc;I':.
1.
BAcKG;ROUND
by
lnresponse to the emerging need for standardized procedures in the OPp. consultation and/or
hospitalization ofIDV/AIDS patients, the Department of Health through the Hospital Operations and
MamgemenlService in collaboration with the Nationill:AIDS/SID Prevention and CO"Jlrbl Program
issued Adminis!rllti"e Order 'No. 27 last :M:~c,h::l994;",Sincethen, the-guidelineshad been:
disseminated to concernedhospitals lJIfough.orie!,\!swlIisemfuars; Wid even through other training
r
workshops conducted
by
'
.
. the.national AIDS prognui
.
:.:' ,
More than a-year after'its issuance.' experisllcli'in field implementation had gradually
accumulated,
WiUllessons learned, the need for
.
. , '.
. .the revision.'of "this
. guidelines
'.
.. became evident.
"
"
II.
OBJECTIVES'
General Objective: . To strengthen the cap3,ll'ility~f:Uie hospital in the prevention and
control ofHIV infection!AIDS.,':
Specific Objectives:
To organize an HlV/AIDS Core,:TellliJ.
~. .
To formulate standardized guidelines: in the management ofHIV/AIDS.
3.
To provide holistic' care to HlV~infe~tediAIDS patients, their families and
signiflcant others including refe,~~~:and, networking withNGOs WId GOs.
4.. " To develop human resoufces';iiecessarv to' carry out the provisions of this
. guidelines,
5. . 'To' Implement Wid op,!,r~J'9.ll1.i,ze: HIVI AIDS-related programmes in the
. hospital.
1.
JJ. OROAtfJ
zArlotfAL1!,S:r;RUCrURE!
.
.. ..
-., .,.
.
'
:"
'
~,
I
I
I
COHMJTTEE
Otl HOSPJ TAL
POLJCJES
Otf
I
I
I
I
_ .J
IUDS
CHIEF
'OF 1I0SPJTfiLS
I--t .. "ACT
.. .
~
SERVICE
HEDICAL/DENTAL"
SERVJCE ..
NURSING
SERVJCE
N.
.
Each DOH hospitalshal! organize lUI HN/AIDS Core TewII (HACf) wbibh shall direetly
reportto the ChiefofHospital. It shall be composed of, butnot limited to the folloWing: doctorts),
dentist(s), lIurse(s), medical social workerts), wid medical teclmologistts) wid have tho following
functions:
1.
2.
3.
4.
S.
6.
7,
8.
'.;'
9.
1.
PHYSICIAN
1.1
1.2
Coordinate with the Hospital Infection Control Conunilt~e" ill Ole strict
implementation of prevention ami infection control measures within the
hospital.
'.
1.3
1.4
..":' ....
.:':,~:.~y:.:~>~:.~~~.::i:;}:::.<.:~....
.-~
. \' .:
1.7::
<'provides post-test counseling,
. . '.'
~
2.
':: .-
'DENTIST
"
'
<
2.1
2:2 '
2.3 '
2.4
2.5
3.
NURSE
,..
,
, 3.1
'3,2
Coordinates patientrcfcrralawithinthehospital.
3.4
3.5
4.
:;.
Provides psychosocial support services including counseling to HIVinfected!AIDS patients and their families.
4.2
.4.3:
'. .4.4
.Provides
beaiUI
education..
. .
.
"
~'.
4.5
5.
MEDICAL'ruCHNOLOGIST
5.1
WI
oral or written
.infonned consent,
5.2
5.4.
5.5
V.
APPROACH TO MANAGEMENT
1.
2.
3.
. .
Sl~'i(lecfed HIV cases s11~dllUldergo mv lUl(ibody testing with lUI infonued cousenr alter
a. pre-lest counselling, Post-test counselling shall be provided to all patients who
The decisi 011 to admit known HIV-infecledlAIDS case shall be det~llniued by the
HACT doctor and shall be admitted to the appropriate ward according 10 the
presenting mrnliibslalion.
5.
6.
7.
8.
-,'
Vl:,RECORDSANDREPORTS'
.;....':::/'i/,"
';fu~1i;~~G~i~tf~,~~:}~~~~~~~~:~,~:t~::~r;;/:;~ ;~::;'I~t~~lO[~'
';;;:'i;y .ri~t~;;!~{i~r~!~~~~~;;;;~~~'u:erocords
"
VII.
'. regulurlyupdated,
3.
.4.
HACT shall submit updated reports 10 concerned offices for statistical purposes
(DOH-National AIDS Registry),
1.
HACT sIll/II fonnulale lJIonitoriug tools :llId guidelines for the lUV/AIDS program
of Ule hospital.
2.
3..
HA~'Tshal1
4.
toNASPCP.
.submit
' annual report
.
".
VIII.
guidelines .
. ".:':
. '.
. .:. . . . . .
GENElW, PROVISIONS
.
.
"'
,"
1.
..
'.
'
.....
,.1.-,.
Confidentiality
.
.
,
All HACT members shall ensure lhat all medical dala andinfonuation bfIllV/AIDS
p:dicllls lU'C maintained with ulmos(confidcntinlitY,. IfACT physicians are required to report
using Ow official HIV/AIDS reporting form (See'ANNEX 3) ~y lUV i1~ection/lm~ c:~e the
HACTmcmbenllulemlfo.lll order to protect the flmdamental right ofpnvacy of lUI individual
with AIDS or iuleeted with lIlV, (lui reporting must be limited 10 Ihe number ofAIDS cases
Wid other statisticsWiUlOUt divulging the .identity ofthe person unless (he pat~ent agrees in
~
writing to the disclosure. .
,
2.
Counselling
All BACT members should be able to provide counselliog to :III patients including
pre- nnd post-testcounaeling,
3.
..
".
'
..'.; ..:lllVlA!DS'pptiimts'have the right to avail of healIII care services in oj1y health care
1hcilily. OnewhohnsHIY Jufecliou/AIDS shnll not be denied his right [0 medical uealment,
.
....
'..
".' .'
'. ;. .
.
:" ~ ."
. . . ; : "":
.:.;".
. ..... TIle HACI' shall be responsible for Iormulating 1l1E' implementing iprocedw'e of
Illis guidelines and such procedure shall be in accordance to the objectives B!ld provisions
of this Administrative Order. '111e scope and.limitations of the Hospital Implementing
Procedure shall be concurrent to the hospital set-up and capacity,
5.
Case Definition
Anyperson wilh or without overt signs and symploms of opporhUlisti~ infection and
gives a conlirmed positive HIV antibody test result is diagnosed to be lllV-ilillJcted. On the
odlerlllllK~ lUI AIDS.case lias one or more of theAIDS-dE'fining conditions (sl:'~ ANNEX 1).
6.
Universal Precautions
Post-Mortem Care
.
All dead bodies shall be considered potentially infected with liN( Procedures
tlmt would entail'physical contact with blood and oilier body fluids shall ~e carried out
with precautions, Cadavers should be properly placed inside a non-permeable material
such as plastic bag before burialor cremation, Physical barriers io prevent exposure of
skill mid ImJCOllS membranes to potentially infected bodyfluids during post-mortem procedure
shall beutilized. Patients who died ofAIDS shall be buried unembalmed within 24 how's or
cremated.
IX.
PENALTY CLAUSE
AllY individual wllo does lUI ac~ ill violation of any of the foresy,ing provisions or fails
todoanactprovided hereof, shall be subjectto appropriate' actlon by proper authorities afler
due notice Wid process.'
.
, .. .." ;':i;;'F!1bu!kd;;rSUp~~A~irlSlrativ~6I'd~rN~.:il>~.'1994'(S~bj;~t;")3~idelilles~n
~,'
inuUediStely."
#~.,
... ~r
ANNEX",,!,;
; -. :.' .;";::.1..: ..
.....
"
....
.',
9;;~~i~~istt~;i~;~~,:i~~~l;;\)-~>;f':;''''>~'\''~ ,::'d':>',
ANNEX'Z:';
,.:UnivenaJ Precautions"
;:,,-,:".r~.~F;!.-'~!~i:~J~;~ bygien~e
': . , .... :'.,::.'
.... ,
b.
c.'
d.
e.
f.
g.
h.
..
pell~Wne~~"QK.;J:I~al$; .
/:;:";,':;,Na,tionalAD.:>SPry'~nti()ltX8n~:
ControlProgram
, ',., '<':'\San:La:rn.roCom.P()~ndi.S~;.C!-11Z;M~la
:' '. -c-, ' . : : ' . , '
."
....
.,- . '
.'
' .
DfI'M,
,1t1J"
Patient's InitiallCode:=
0'
~-_
----'----,----.-jf---
....
-,-_ _-t)
I
I .
,'"
Initial
Report Type:
Date
or Report:
..'
_
--,.
-:-__
AdcJressrrc1.N~.;--.
.;
"
ReCerrrlng Agency:'
.. ,
=:-":.../,...,..--------"-_
Reportlng Agencyll'hys!clan:.
. .AddIessJTe1:
No.:
,
.' c.
__._--!L
I
=l-
Annex H
List of HIV Treatment Centers
58
Chief of Hospital
San Lazaro Hospital
Telefax No. 711-6979
Executive Director
Research Institute of Tropical Medicine
Telefax No. 842-2245
Chief of Hospital
lIocos Training and Regional Medical Center
Telefax No. 888-3671
Medical Director
Philippine General Hospital
Telefax No. 524-2221
59
Annex I
Administrative Order No. 2005 - 0027
60
I.
Background/Rationale:
II.
Objective:
These rules and regulations are promulgated to ensure utmost safety and
quality in the performance of HIV testing by laboratories.
III.
Scope:
2.
1.2
Particle Agglutination (PA)
1.3
Other screening tests for HIV antibody
Confirmatory tests for HIV antibody
2.1
Western Blot (WB)
2.2
Immunofluorescence (IF)
2.3
Radio Immune-Precipitation Assay (RIPA)
2.4
Other supplemental tests for HIV antibody
IV.
Definition of Terms:
A.
B.
C.
D.
E;
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
P.
V.
A.
General
1.
Only licensed clinical laboratory and/or blood center designated by the
NVBSP are allowed to operate an HIV testing laboratory provided that requirements
set forth in these regulations are met. Permission' to operate an HIV testing
laboratory shall be included in the License to Operate a clinical laboratory or blood
center.
2.
The BHFS or the CHD may conduct unannounced on site monitoring visits
and shall document the overall quality of the laboratory setting.
3.
The HIV testing laboratory shall be a section/unit /division of a clinical
laboratory or blood center.
4.
The number of HIV testing laboratory an HIV Proficient Medical Technologist
can handle shall be based on the Guidelines on Quality Assurance Program for HIV
Testing Laboratories set forth by the NRLSACCUSLH.
B.
Specific
1.
Physical Plant
There shall be a designated area within the clillical laboratory or blood center
adequate enough for the conduct of HIV testing. The designated area shall be welllighted and ventilated. dust free with adequate water supply and provision of an area
for decontamination of infectious/contaminated materials. Further, there shall be a
designated area (outside the laboratory) accessible for pre and post-test counseling.
2.
Personnel
The HIV testing laboratory shall have a licensed Medical Technologist with
training in HIV Proficiency Testing certified by the NRL-SACCUSLH. The HIV
Proficiency Certificate of the Medical Technologist shall be posted in a conspicuous
place within the laboratory.
3.
Equipment/Supplies
a.
The HIV testing laboratory shall have the appropriate equipment and
necessarysupplies for HIV testing which include personal protective devices.
b.
The HIV testing laboratory shall utilize reagents, such as HIV test kits,
which have been registered with the BFAD and with a valid Certificate of Product
Registration (CPR). However, for screening of blood donors, only BFAD registered
kits shall be used.
4.
Laboratory Reports
a.
The report form issued to the client shall indicate the name/laboratory
code of patient, age, sex, address, date of specimen received, requesting physician,
screening assay result (name of kit, lot number used, cut off value and patient's
absorbance, when necessary) and name and signature of the analyst and head of
the laboratory. Reporting of confirmatory result shall include among others
confirmatory assay results (name of kit, lot number used, brand present and/or grade
of IF results, If any).
b.
Each HIV testing laboratory shall maintain a documentary evidence (or
records) of all HIV testing performed, results and referrals of sera-active samples.
This should be made available during monitoring visitslinspection or at any time
deemed necessary.
.
c.
Reactive samples shall be referred for confirmatory testing to NRLSACCUSLH. Reactive samples for blood units/blood donors shall be referred for
confirmatory testing to NRL-RlTM NVBSP. Laboratories other than NRL may perform
confirmatory testing provided that the Philippine National AIDS Council upon the
recommendation of NRL- SACCUSLH deputizes it.
d.
Each HIV testing laboratory shall submit a quarterly report to the DOHNational Epidemiology Center on the number of tests performed, results and
referrals of sere-reactive samples and confirmed sero-active samples as required
under R.A. 3573 using the HIV/AIDS Case Reporting Format which can be
downloaded in this website: www.doh.gov.ph/saccl.
5.
Procedural Guidelines
A.
2. List
of
personnel,
including
photocopies
of
valid
PRe
identification cards and current certificates of HIV proficiency training
3. List of equipment with specifications
4. Current certificate of EQAS Participation from NRL-SACCUSLH (renewal
only)
B.
C.
VII.
Violations
Penalty
Any clinical laboratorylblood center performing HIV testing that violates these
rules and regulations shall be liable under the Clinical Laboratory Law (R.A. 4688) or
National Blood Services Act 0(-1994 (R.A. 7719) or Philippine AIDS Prevention and
Control Act of 1998 (R.A. 8504) and suffer penalties provided for- in the law and its
Implementing Rules and RegUlations. Such violations shall be basis for sanctions
including suspension or revocation of the license to operate the clinical laboratory/
blood center.
IX.
Appeal
Any HIV testing laboratory, or any of its personnel aggrieved by the decision
of the BHFS may, wlthin ten (10) days after receipt of the notice of the decision, file a
notice of appeal with the Office of the Secretary and serve a copy of the notice of
appeal to the BHFS. Thereupon, the BHFS shall promptly certify and file a copy of
the decision, including all documents and transcript of hearings on which the
decision is based, with the Office of the Secretary, for review. The decision of the
Office of the Secretary shall be final and executory.
X.
Separability Clause
In the event that any provision or part of this Order be declared unauthorized
or rendered invalid by any court of law or competent authority, those provisions not
affected by such declaration shall remain valid and effective.
XI.
Repealing Clause
These rules and regulations shall repeal and supercede all administrative
orders and previous issuances inconsistent thereof.
XII.
Effectivity
These rules and regulations shall take effect fifteen (15) days after publication
Ina newspaper of general circulation.
CO T.
Secretary of Health
Annex J
Administrative Order No. 2005 - 0032
61
Administrative Order
No. 4.o~!i~oo99.
SUBJECT:
I. RATIONALE! BACKGROUND:
HIVIAIDS isone ofthe diseases that have to be combated as reflected in the Millennium
Development Goal, proposed issuance alluned to the said international commitment. This is also
being addressed in the Medium Term Development Plan and the national directions/thrust. To
sustain this goal. HIV testing laboratories have to be standardized to maintain quality results for
proper diagnosis ot HIV/AIDS. The STD/AIDS Cooperative Central Laboratories! san Lazaro
Hospital (SACCL) was designated as the Nationai Re(erence Laboratory (NRL) for HIVIAIDS,
Hepatitis and STls. Pursuant to the Department Order no. 393-E s.2000 of the Department of
Health, the functions of the NRL-SACCUSLH are the following: to maintain Quality Assurance
Program (OAP) for laboratory tests - in coordination with the Bureau of Health Facilities and
Services, Department of Health (DOH); to provide laboratory referrals services, e.g. for
confirmatory testing, surveillance, research; to train laboratory personnel; and to evaluate kits and
reagents in coordination with the Bureau 01 Food. and Drugs (BFAD) and the Bureau of Health
Devices and Technology (BHDT), DOH. The NRL-SACCUSLH has lully deveioped their service
. capabilities including QAP for HIV, Hepatitis B, Hepalitis C and other Sexually Transmitted
Infections. NRL-SACCUSLH is responsible for all referrals Irom private and govemment
laboratories for confirmatory tests and for resolution ofdiscrepant and conflicting HIV test results.
The Quality Assurance Program (QAP) guarantees the accuracy of the final results
reported by a laboratory. It involves proper training oflaboratory personnel inhandling specimens,
reviewing transcriptional measures, verifying final results. and using most reliable assays. The
External Quality Assessrnent Scheme (EQAS) is established to evaluate the effectiveness of lhe
QAP. EQAS is an external evaluation ofa laboratory's performance using a proficiency panels.
. Failure ofthe HIV testing center to obtain satisfactory rating indicates deficiencies with the Quality
Assurance/ Quality Control (QAlQC) procedures in the laboratory.
All HIV testing laboratories need to be fully established and monitored through the QAP
to assess, and improve !he quality 01 testing and performance oflhese laboratories.
To establish and promote Quality Assurance Program for all HIV testing laboratories.
To provide training for medicallechnologists performing HIV testing.
To strengthen coordination thru networking among HIV testing laboratories.
V. DEFINITION OF TERMS
. QualIty Assurance - an overall program that ensures that the final results reported by the
laboratory are correct as accurate as possible.
Quality Assessment - is a means to determine the quality of results. It is usually an
external evaluation ofa laboratory's performance that relies on incorporating proficiency panels of
well-characterized sera into the testing routine. It challenges the effectiveness of the quality
assurance program.
External Quality Assessment (EQAs) Panels - a set ofserum samples that is used to
validate the performance of laboratories which are sent in support of the external proficiency
. program designed to determine the ability of the laboratories to accurately test samples and
report results.
External Quality Assessment Scheme (EQAS) - an external evaluation of a laboratory's
performance using proficiency panels and assessed by the National Reference Laboratory for
HIV/AIDS, Hepatitis and STls. Failure of the HIV testing center 10 obtain satisfactory rating
indicates deficiencies with the Quality Assurancel Quality Control (QA/QC) procedures in the
laboratory. Further, failure to participate in an authorized EQAs shall be grounds for suspension,
. non-renewal or revocation ofthe HIV accreditation ofthe laboratory.
EQAS Participants - laboratories participating in the External Quality Assessment Scheme
conducted by the NRL-SACCUSLH.
Training Participants - medical technologists who are undergoing HIV proficiency training
either for initial HIV accreditation orrenewal of HIV proficiency licenses.
.'
Proficiency Certificate- refers to the citation received by the medical technologist after they
have undergone initial and renewal ofHIV proficiency training.
Certificate of Qualification- refers to the certification issued after the clinical laboratory has
achieved satisfactory results in EQAS.
Certificate of Participation - refers to the certification issued after the clinical laboratory has
participated in EQAS.
. VI. QUALITY ASSURANCE GUIDELINES
A. Requirements for Quality Results
A.1. Recording
A.1.1. Record keeping. An efficient HIV laboratory shall be able to monitor the records
of specimens from the time the samples are received until the time the results are
released. Appropriate logbooks are essential step in recording. It must be kept
confidential and must include the following:
.
a. Name and/or specimen identification
b. Address or source ofspecimen
c. The date of sample collection
d. The name ofrequesting physician
e. The specific test required
f. Adequacy ofsamples received
A.1.2. Worksheets. This serves as a work map for each test run. This should be filled
up before the test is performed and must be kept for a permanent record. The results
after each test run should be reflected in \he worksheets and should also contain the
following:
a. Kit lotnumber
b. Expiration date
c. Date ofperformance
d. Medical technologist's initial
e. Supervisor's signature
A.1.3. Daily log sheets. this includes the daUy records of temperature of water baths,
incubators. refrigerators and freezers or any documents to show that the operating
conditions ofthese equipment are maintained appropriately.
A.1.4. Reviewing of transcriptional measures
Transcriptional or clerical error includes mistakes made during the transfer of
information from the test readout to the worksheet. and from \he worksheet to the
computer orreport fonn. System must be developed tore-check results in each of these
steps. The following mechanism shall be observed:
a. Have a second proficient medical technologist read the results from the
instrumenl/ worksheel/ computer to another technologist who will check the final
result, and/or
b. Have a supervisor check all results at the end of the day, before releasing the
results ofthe laboratory.
A.2. Testing
A.2.1. Testing algorithm for HIV testing
All HIV testing laboratories must estabtish their own testing algorithm patterned
on the NRL-SACCUSlH algorithm depending on the service capabOity they have. The
NRL-SACCUSLH testing algorithm is indicated in Annex 1 for both screening and
confinnatory tests. This will serve as a guide for the laboratory personnel in the proper
interpretation and management ofHIV diagnosis.
g. Confinnatory Assay results (name ofkit &lot number used, bands present
and/or ofreactivity of IF results, ifany)
h. Remarl<s and comments
i. Signature ofthe proficient medical technologist
j. Signature ofthe pathologist
A.4. Storage of reactive and 'indeterminate specimen for follow-up testing
Reactive serum specimen must be stored in -20 C for follow-up testing
containing a minimum of 500 ulvolume, and placed in a plastic screw capped vial. A log
book containing all the pertinent information should be capable of identifying stored
samples. To preserve the integrity ofsamples, aliquot into several vials is recommended.
This avoids repeat freeze thawing.
Stored serum specimen must be labeled properly using water proof fine point
marking pens.
Reactive specimen SUbject for confirmatory and/or validation oftest results must
be submitted and transported with care. The specimen must be packed with the
following instruction indicated in Annex 3 to ensure the safety ofthe personnel handling
the specimen during transport. A written communication must be attached
IndependenUy outside the package where the serum specimen are kept. 1\ is appropriate
to declare that the samples are potentially infectious and written clearly in the package.
Transport ofspecimen byair freight should follow the aircraft's rules and regulations.
B.Standard Operating Procedure (SOP).
Standard Operating Procedures (SOPS) should be adhered to in the laboratory
at all times. 1\ includes the detailed protocols, principles and explanations of all the
procedures performed within the laboratory. The laboratory manager shall monitor the
performance of the proficient medical technologists to ensure that the SOPs are being
followed. Package inserts can be used as areference but not as substitute for the SOPs.
C.
will be subject for supervisory visit. Any discordant results obtained on the said
panels will be monitored by repeattesllng orwill be given another set ofpanels
as the case may be.
e. Certificate ofparticipation shall be granted to participants obtaining
unsatisfactory results after the supervisory visit. A recommendation to BHFS
shall be forwarded to address the problem for further evaluation and appropriate
action.
VIII. TRAINING.
All HIV testing laboratories are dependent on the quality ofwork generated as part of the
Quality Assurance Program by the proficiency of the medical technologist. HIV proficiency
training of medical technologist shall be provided by the NRLSACCUSLH to maintain Ihe
effectiveness ofthe quality assurance and for accreditation purposes.
A. Requirements of initial HIV proficiency training
a. Accomplished application form provided by the NRL-SACCUSLH (a prototype of the
application forms are posted atthe DOH website www.doh.gov.ph/saccl ).
b. Photocopy ofPRC ID;
c. Letter of endorsement from the pathologist or head of agency and certification that
he/she is a practicing technologist inlaboratory work;
d. Registration fee 10 be paid directly to San Lazaro Hsopilal to defray the cost of the
training materials. reagents and serum panel preparations.
B. Scope of the Proficiency training
a. Laboratory safety and precautions and waste management
b. Laboratory screening methods for HIV and HCV antibody, HBsAg and Syphilis including
principles inVOlved, methodology and technical trouble shooting, QC/QA Program
c. Nature ofHIV Infection, Epidemiology, clinical manifestation and laboratory diagnosis
Social, ethical and legal aspects of HiV infecllon
d. Pre-post donalion/tesl'counseling
.
e. HIVaccreditation for clinical laboratory
.C. HIV Proficiency Training shall bebased Inthefollowing:
a.
b.
c.
d.
e.
Lectures/discussion
Practicum/hands-on
Demonstration
Discussion ofproblem cases
Pre and post written exams, quizzes and practical examinations
10
1I
The following violations shall be grounds for non issuance ofcertificate ofparticipation:
1. The use ofunregistered lor expired certificate ofproduct registration for HIV test kits
and reagenls;
2. Performance ofHIV testing without valid proficiency training certificate;
3. Unauthorized use of proficiency Certificate by non proficient medical technologist
performing the test.
4. Switching of EQAS panels to and from other HIV facilities;
5. Falsification ofdocumenls pertinent to EQAS results.
XII. Separability! Repealing Clause
In the event that any section, paragraph, sentence, clause or word of this order is
declared invalid for whatever, any reason, other provisions thereof shall not be affected thereby.
These guidelines shall repeal and supercede all administrative orders and previous
issuances inconsistent thereof.
XIII. Effectivity
These guidelines shall 'take effect fifteen (15) days after its pUblication in a newspaper of
general circulation.
12
ANNEX 1
National Relercn,:" ..',horatory lor HIV, Hepatitis and other STis
,sam
__..ole lested
r-r
...-------.~
Both Methods
Nonreactive
::---==:._-_.-
DiscoIdanl or inconclusive
Both Methods
Readive
linmunoflourescent
Test OF)
Immunoflourescent
Test (IF)
Report as
Negative
Western Blot
Negative
Report as negative to
Anti-HIV
Indeterminate
Report as Indeterminate
(repeal blood test after 3-6
months)
Report as
Posilive
Positive
Report as positive to
AntiHIV
ANNEX2a
National Reference Laboratory for HIV, Hepatitis, and other STls
STO I AIDS COOPERATIVE CENTRAL LABORATORY
San LazaroHospitalCompound. Quiricada St., Sta. Cruz, Manila
Tel Nos: 3099528/29 Telelax: 711-4117 e-mail: sacd@compaos.com.ph
Fax Number:
PatientName/ Code:
Age: __ Sex: _.
Blrthdate:
CivllStatlls:
Occupation:
Nationality:
Date bloodcollected:
serum
n~P!.o!!~~
bloodun;/
Interpretation
Test 1
plasma
0.0.
C.O.V.
date tested
__ _____________________ .
--------.-------.
I -----------------
--------------------------------- ----------------.
I -----------------
I .----------------
.....
---- .. ------._-------._----______________________________
Lg!~
Tesl2
n~!_o!!i!~
_________________________
I
____________________ .____
._----------_._----------------_.______________________________ -----------------
~9t~
~ fOR STRICTCOMPLIANCE.
SpacimenMUST NOT be HEMOLYZED or LIPEMIC. A minimumvoIuma of et LEAST500ulis required.
Preferably use PLASTICcontainers(I.e. cryovials). DO NOT use GLASSlubes for transport.
Submitsample together with PROPERLY fdJed up mimi! and ~ reporting form. HIV ConfirmalDIY Is FREE of CHARGE.
Storein freezer if there'sdelay.
--------..,..,..-::-"'7'::---:-...,......
RMT
MedicalTeChnologist
(signature overptintetllM1Tle)
_ _ _ _ _ _ _ _ _ _ _ _ _ .MD
PathologiSt
(signature over printed name)
ANNEX2b
INFORMED CONSENT AND PRETEST COUNSELING DETAILS
FOR LABORATORY RETROVIRAL DISEASE TESTING
A. Explanation about tiletest
1. What isHIV antibody testing?
HIV antibody is a blood test. It will show if you have antibodies 10 HIV. the virus
that causes AIDS. ASAMPLE OF BLOOD WILL BE TAKEN FROM YOUR ARM. Ifthe first
rest (screening) shows a positive reaction. another lest (oonfirmatory) will be done to make
sure thai the flfSl lest is really positive. A positive anlibody test means you have been
infected with HIV. A negative test means you are probably not infecled. Bul i1tal<es time for
the body 10 produce antibodies, so if you have been exposed recently, you need to be
retested after several months to make sure you are not infecled.
.
Taking an HIV antibody test isvoluntary. Ifyou do not want to be tested, you have
the right to refuse the lest. Ifyou want tohave the test but don't want toreveal your identity,
you can use acode narne.
( ) None
Inclusive Dale
() No
Puroose
_
_
Result
My questions about testing have been answered. I, therefore, agree to lake the HIV
antibody lest and olher tests as deemed necessary.
Date:
Name/Code: __.
Address:
Signature:
AgeJsex:' __.._ .
__
_
..
I have explained the HIV antibody test, how it isdone, the meaning ofthe results and the possible
consequence ofdisclosure.
Name of Physician/Counselor:
Designation:
Date:
_
_
ANNEX 3
1. Dispense at least 500 ul ofserum specimen to a screw cap (1.0 ml) cryovial.
2. Clearly label specimen with patient's name orcode with water proof cryo marker
pen.
3. Seaied the cryovial with paraffin film and wrap with tissue orabsorbent paper!
material.
4. Tie with rubber band around the absorbent tissue orpaper material.
5.
9. Write the name ofthe sender orthe Pathologist and the name/address ofthe
HIV accredited laboratory.
10. Include in the package all pertinent documents sealed in plastic envelope such
as:
a. Filled up request form;
b. Inform consent and pre-test counseling details;
c. Laboratory test results ofthe particular specimen to be transported.
11. Send specimen package to the:
National Reference Laboratory for HIV, Hepatitis and Blood Borne STis
STD/AIDS Cooperative Central Laboratory
5an Lazaro Hospital Compound, DOH
Sta. Cruz, Manila 1003
nemlNo.
Brand
Work Done
Maintenance I Calibration
Location
Jan.
Feb.
Date Performed
Apr.
Mar.
Remarks
May June
:z
:z
I
I
I
m
X
I
I
I
I
I
Name ofTechnician:
Annex K
Department Order No. 393 - E s. 2000
62
No.
3'3-G
8.2000
SUBJECT:
OF
SUPpLIES,
PECIMENS,
CORRESpONplNG
RECORp
EQUIPMENT,
FROM
THE
INSTRUMENTS,
BUREAU OF
As part of the Department of Health's goal of streamlining the Central Office In line with
devolution and decentralization of functions to improve the qualny of health services and establish
an effectlve pUblic health laboratory network In the countrY, the following Instnutions, In addition to
their regUlar responsibililles, are hereby designated as National Reference Laboratories (HRLs)
effective November 1, 2000.
Research Institute for Tropical Medicine - National Reference Laboratory for Dengue,
Influenza, Tuberculosis and other Mycobaeleria, Malaria and other parasltes, Baelerial enteric
diseases, Measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance
and Emerging Diseases; NRL for confirmatory testing of blood donors and blood units.
Sa(i Lazaro Hospital National Reference LaboratOlY for HIV/AIDS, Hepatitis; and SexuallyTransmitted Diseases.
East Avenue Medical Center - National Reference Laboratory for Environmental and'
.
Occupallonal Health; Toxicology and Micronutrient Assay..
National Kidney and Transplant Institute National Reference Laboratory for Hematology
including Immunohematology (consistent with previously issued D.O. 301-1 s. 1999).
Lung Center of the Philippines - National Reference Laboratory for Anatomic Pathology arid
Biochemistry.
.
The above institutions should develop their capabilities to fulfill the following functions as
National Reference Laboratories:
a. To providelaboratory referral services, e.g. for confirmatory testing, surveillance,
research.
b. To train laboratory personnel.
c. To maintain a qualityassurance program for laboratory tests - in coordination with the
Bureau of HealthFacilities and Services, DOH.
d. To evaluate test kits and reagents - In coordination with the Bureau of Food and Drugs
and the Bureau of Health Devices and Technology, DOH.
The Bureau of. Research and laboratories (BRL) Is hereby ordered to endorse all
equipment, Instruments/devices, IUpplieS, apecimens and relevant records of Its various
laboratories to the corresponding designated National Reference laboratories.
To facilitate the smooth tum-over of the laboratory functions of BRL to the designated
National Reference laboratories, the following task forces are created to develop the transition
plan for each NRL and oversee the Implementation of transition plan upon approval of the DOH
Executive Committee.
A. RITM National Reference Laboratory:
Chairperson:
Dr. Socorro Luplsan Head. Laboratory Research Division, RtTM
Members:
Dr. Veronica cnan- Consultant. BRL
Dr. FemJuliaPaladin Head, Virology Dept., RITM
Ms. Ellen Castillo Head. TB SectJon, RITM
Ms. Lydia Sombrero Head, Gen. Bacteriology Section, RITM
Ms. Nenlta Canafranca ChiefMed. Tech., Bacteriology SectJon. BRL
Dr. Cielo Pasay Head, ParasItology Dept., RITM
Ms. Angelita Jimenez, ChiefMed. Tech, Parasitology Section, BRL
Dr. Rose Capedlng Head, Bacteriology Dept., RITM
Dr. Daria Manalo - Veterinary Reaearch Dept., RITM
Dr. MaryElizabeth Miranda Veterinary research Dept., RITM
Dr. cella Carlos - Program Director, Antimicrobial Resistance and
SUNeUlance Program. RITM
Or. Rosita de Leon - Chief, Laboretory Division I, BRL
B. San Lezaro Hospital National Reference Laboratory:
Chairperson:
Dr. Dorothy Agdamag - Medical Specialist III, San Lezaro HaSp.
Members:
Mrs. Myrna Reyes ChiefMad. Tech., Immunology Section, BRL
Or. Fem JuliaPaladin - Head. Virology Dept., RITM
C. East Avenue Medical CenterNational Reference Laboratory:
Chairperson:
Or. Socorro Yanez - Head, Dept. of laboratories, EAMC
Members:
Or. Marilyn Barza - Medical OfficerVII, East Avenue Medical center
Mrs,. Celina Pacls ChiefChemist. Environmental Health Examination
SectJon, BRL
D. NKTI National Reference Laboratory:
Chairperson: Or. Juanlto Blllote - Deputy Director, NKTI
Members:
Or. Jane Baylon Chairman, Stem Cell and CryopreseNatlon Dept. NKTI
Or. Januarlo VeioBO Head, Hematology & Transfusion Division, NKTI
Ms. Cecille Cuerde>- ChiefMad. Tech,lmmunohematology Section, BRL
Ms. Annarlssa Bumanlag- ChiefMed. Tech., Hematology Section, BRL
Annex L
Administrative Order No. 55-A s. 1989
63
Aciffiinistr~tive
Crder
series --.,/9tf
;r-f:-It
No.
'January 2, 1989
1 -
Title:
"RULES
These Rules
and
R~GULATIONS GOVERNING
AND
rRE~~DrATION'
Or
.t n
accordance
s:.
a.s.
to
,4688,
1.517
(Clinical
Laboratory
E.O.
to
:; - Purpose:
protect
and
the performance,
-'
and
b Lood
promote
an(~,
banks
and
(;~eo"g8nization
119
Sec.
Law)
the
health
of
licensed
according
to
by, reg~18ting
the
?eople
mv
testing in laJ;lOratories
the
implementing Rules
and
'The
regulations
embodied
herein
".
pe rso n ,
corporacion~
bank
or
in
performing
che
Pha Li pp i.ne s
for
determination
antigen/protein,
of
viral
to
the
?r
blood
perrormRlV' testing
public
for, d i ag no st f c
t~$ting
EIV
he
:.
l abo r a t or y-:'
seeking
:0 any
shan "apply,
pr e senc e
particles
in
shall incluce
of
ant i.body ,
cl Ln i c e l
Regulatory
Authority:
Lebo;cat,ories/Blood ,Eanits
be -exe r c t se d by
Research
and
unde r
The
t
Accreditation
he se . ru l e s
of'
uiv
Laboratories
in
'Office
fo~
Stendarcs
anG
Sec. 6 ..:
6.1
of
the
f911~wing
Ac c r e'd i t a t i.o n :
1sbo=etory
proce4ures
shall
I?
Page 2
.=============~======
1)
1.1
1.2
1.3
2)
3)
Others
2.1
2.2
lmmunoflourescence (IF)
2.3
2.4
Others
laboratory'
Other
procedures
such
as
test ing
accreditation
by
the
Department
of
Health'
6.3
No
lilV
by
the
unless
the
laboratory
procedure
has
. All
clinical
requireci
be
f o Ll owf ng
laboratories
to
or
demonstrate
Technical
blood
banks
sha l l
compiiance' with
Standards
the
a . requirement
as
to accreditation:
1)
The
be
clinical
du ly
laboratory
licensed
by
or
the
blood
Bureau
bank
of
shall'
Research
and LaLoratories.
2)
The
laboratory
shall
be
headed
by
and
under
who
is
certified
by
the
Philippine
The
t
laboratory.
ecbnc l ogI s t s
of
Medical
shall
duly
be
staffed
registered
Technology,
who
"ith
have
by
the
medi ca l
Board
,undergone
Administrative Order
Page 3
====================
by a training laboratory.
,4)
The
physical
plant
and
ventilated,
be
be hous ed in well-lighted
dust-free
areas
with
an
adequate
supply of water.
should
shall
sufficient
to
accomodate' the
activities
equipment,
and
supplies
other
needed
Reagents:
The
laboratory
ut i l ize
shall
reagents,
such
as
Report
objective
report
The
forms
and
indicate
the
forms
should
be, clear;
(brand/
manufacturer) utilized.
7.2
The
Bureau
compliance
to
of
Research
with
such
and
technical
standards
in
accordance
and Regulations.
Sec. 8 - Reporting:
Each
tests, done,
HIV
testing
laboratory
shall
report
monthly
the
number of
9.1
All
or
serum
PA)
by
samples
reactive
in
private
laboratories
sc reen t ng
shall
be
tests
referred
(EIA
to
All
or
serum
PA)
by
samples
reactive
government
in
screening
laboratories
shall
tests
be
(EIA
referred
The
to
names,
be
age,
seropositive
(by
WB/IF/RIPA)
shall
be
confirmed
reported
Administrat<.ve. :~er
Page 4
====================
to
AIDS
Registrar,
accordance
to
Health
Department
Intelligence' Service,
Circular
No.
11,
s.
DOH
1987
in
dated
Such
a
person
shall
be
informed
of
the
implications
of
requirement of a confidential
10
Quality
Control
Tests:
The
Direc.tor
of
the
Bureau
ill
Sec.
records
Inspection:
HIV
testing
laboratory
facilities
and
Director
his
of
duly
reasonable
the
Bureau
authorized
time
and
of
Research
and
representative(s)
opportunity
to
Laboratories
shall
inspect
be
the
given
premises
laboratory
the
Bureau
authorized
shall
of
make
available
Research
representative
and
all
to . the
Director
kepr" pursuant
duly
to
Director
his
of
the
Bureau
of
representative. may be
Research
assisted
and
Laboratories
by duly designated
of
Regional
Health
Health
Officers
'Bureau
of
Municipal
report
to
existence
any
the
of
private
are
HIV
performing
and
test
'directed
Laboratories
testing
such
~ity
Provincial,
hereby
Research
unaccredited
party
Offices,
laboratories
without
to
the
or
proper
accreditation certificate.
Sec.
or
12
corporation
Bureau
of
desiring
Research
the prescribed
1)
Basic
and
Accreditation
to
Requirements:
perform' HIV
Laboratories,
testing
sworn
Any
shall
person,
submit
to
firm
the
petition/application on
Name,
citizenship
Testing Laboratory.
and
domicile
of
the
head
of
the
HIV
........-----
Administrativ~ OrGer
Page 5
====================
established.
3)
4~
5')
Copy of
An
a
application
form
for'
accreditation
"Application
performing
HIV
for
shall
Accreditation
testing" with
be
of
the Office
filed
in
Laboratories
of
the Bureau
the
applicant
or
person
duly
authorized
to
act'
verify
the
if
applicant
has
complied
13.4
Any
material
failure
false
statement
to comply with
in
the
v
-,'
with
the
'
application
or
basis
refuse
recommending
the
issuance
of
certificate
of accreditation.
Sec. 14 - Accreditation Fees:
14.1
14.2
14.3
All
fees
shall
be
payable
to
the Bureau
of Research
14.4,
P 500.00
P 250.00
....I ......
~c
.. _.
Administrativ~
Order
Page 6
14.5
Sixty
'unrenewed
and
days
(60)
after
expiration
certificates
cer~~fica~e
new
shall
be
shall
have
accreditation,
'0.
considered
to
be
lapsed,
applied
for.
The
certificate
Undersecretary
the
if
will
of
be
issued, and
Health
application
for
signed
Standards
is found
and
by
the
Regulation
to be meritorious and
the
The
accreditation
conspicuous
the
rules
certificate
place
and
within
should
the
regulations
be
placed
laboratory'.
shall
be
in
A copy
readily
a
of
available
The
certificate
the
certificate
transferred
16.2
party
The
owner
desiring
the
within
herein granted
shall
directly
or
to
shOUld
.1
be
to
right' unde r
any
assigned
indirectly
of
transfer
of
the
new place
fifteen
(15)
or
an
.oche rwt s e
unauthorized
HIV
another
and
and
of
after
laboratory
place, shall
Labo r a to r'Les
site
days
testing
such
in
inform
writ ing,
The
antibody
notify
any
to
Research
Any HIV
or
manager
new facilities
16.3
not
or
... >
Bureau
stating
as
laboratory
the
Bureau
of
Research
and
Laboratories
"I
Any
pathologist
who
decides
Laboratories
within
to
terminate'
services
or
fifteen
(15)
days
after
such
termination or transfer.
16.5
revocation
of
the
certificate
of
Accreditation
of
the laboratory.
. . . /7
Administrative- Order
Page 7
==========~==~======
Each
the
date
certificate
shall
expire
one
year
after
be filed at least Sixty (60) days before the expiration of the certificate
in
accordance
shall
to
Sec.
14.
The
Research
and Laboratories
to
however,
the Director,
upon
of
subject
action. on
inspection
Bureau
the
application,
discretion
unless
of
the
otherwise
Director;
advised
provided'
or ordered by
to cease operation.
A list
of
laboratories
HIV
testing
be
published
under
and
these
blood
rules
periodically
and
regulations
be
made
shall
available
to
The
results
of
quality
control
testing ,shall
likewise
be published.
Sec. 20 - Modification and Revocation of Certificates:
T\le terms and conditions of each certificate shall be subject
to amendment or modification !,ly means of amendments to these regulations
as
the Secretary
willful,
of
Health may
deem necessary.
Except
in cases of
revoked
unless
prior
notice
has
been made
and
the
corresponding
investigation conducted,
Sec. 21 - Violations:
21.1
The
certificate
perform
HIV
of
testing
accreditation
shall
be
of
suspended
laboratory
or
revoked
to
by
violation of
, . . . /8
1)
false
or medical
2)
Any
3)
4)
Repeated
failure
statement
to
submit
in
technologist.
the
application.
monthly
report
with
5)
(confirmatory)
of
testing
Tropical
to
Medicine
the
or
Research
Bureau
of
Institute
Research
and
Laboratories.
to
Failure
6)
seropositive
confirmed
report
cases
Refusal
to
allow
persons
authorized
inspection
by
the
of
the
Bureau
laboratory
by
Research
and
of
Refusal
Failure
time
to
correct
after
due
notice
from
the
and Laboratories.
21.2
Any
HIV
Testing
and
Laboratory
shall
Laboratory
Law
1517)
suffer
and
and
the
Revised
to such law.
including
(R.A.
be
4688)
penalties
Rules
and
that
violates
1iab l e
under
or
Blood
provided
Regulations
these
the
Bank
for
Clinical
LaW
in
rules
(R.A.
the law
issued. pur-suant;
suspension
or
revocation
of
the
license
to
22
effect fifteen
EffectiVity:
(15)
regulations shall
take
Annex M
Memorandum Circular No. 2006 0075
64
25 October 2006
MEMORANDUM CIRCULAR
No. .100<;- OO"'t5
TO:
SUBJECT:
DOH Centrallibrory