Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
May
29, 2019
DEPARTMENT CIRCULAR
No. 2019 - 0497

TO : ALL REGIONAL DIRECTORS, HEADS OF HOSPITALS AND

OTHER HEALTH FACILITIES, CHIEFS OF THE HEALTH
FACILITIES AND SERVICES REGULATORY BUREAU AND
THE CENTERS FOR HEALTH DEVELOPMENT -
REGULATION, LICENSING AND ENFORCEMENT
DIVISION, MINISTRY OF HEALTH OF THE BANGSAMORO
AUTONOMOUS REGION IN MUSLIM MINDANAO (MOH-
BARMM), REGULATORY OFFICERS AND OTHER
STAKEHOLDERS CONCERNED

SUBJECT: Guidelines in Securing a License to Operate a Certified rHIVda

Confirmatory Laboratory (CrCL)

L. Rationale

Administrative Order (A.O.) No. 2019-0001, dated January 10, 2019, titled
“Guidelines on the Implementation of Rapid HIV Diagnostic Algoritm (rHIVda)”, was issued
by the Disease Prevention and Control Bureau of the DOH in coordination with the World
Health Organization (WHO) and National Reference Laboratory — San Lazaro Hospital /
STD AIDS Cooperative Central Laboratory (NRL-SLH/SACCL) with technical assistance
from HIV National Reference Laboratory Australia. The recommended new testing
algorithm, in lieu of Western Blot, will allow early and accurate confirmation of the HIV
infection, thus prompting initiation of early treatment and prevention of loss to follow up of
patients. Any DOH licensed clinical laboratory, identified by DPCB in coordination with
NRL-SLH/SACCL, shall be allowed to establish a Certified rHIVda Confirmatory
Laboratory (CrCL) using this new algorithm.

Currently, the Health Facilities and Services Regulatory Bureau (HFSRB) issues
License to Operate (LTO) to compliant clinical laboratories which offer HIV screening tests,
with this service subsumed in the LTO as an add-on service of the clinical laboratory.

II. Implementing Guidelines

A. General Guidelines
1. Only DOH licensed clinical laboratories identified by the program, in
coordination with NRL-SLH/SACCL, shall be allowed to apply for CrCL.

2. The DOH licensed clinical laboratory shall secure a certificate as “Certified

rHIVda Confirmatory Laboratory” from the NRL-SLH/SACCL or its
designated regional counterpart, prior to application of DOH-LTO CrCL.

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 11412, 1113
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: [email protected]
 3. The NRL-SLH/SACCL and its designated regional counterpart shall be a
different entity from CHD-RLED.

4. The CrCL
laboratory.
may
be a section, unit, or division integrated in a licensed clinical

5. Timeline for the processing of complete application to issuance of the DOH-

LTO shall follow the citizen’s charter timeline prescribed by the Bureau.

6. DOH-LTO CrCL shall be secured from:

a. HFSRB — for institution-based clinical laboratories in Levels 2 and 3
general hospitals, and specialty hospitals.
b. CHD-RLEDs — for institution-based clinical laboratories in Level 1
hospitals, RHUs and SHCs.

7. DOH-LTO CrCL shall be signed by the Director [V of HFSRB or Center for

Health Development (CHD), or his designate.

8. DOH-LTO CrCL shall be renewed annually and shall follow the current
schedule of fees.

B. Specific Guidelines
1. The application for licensing a CrCL shall be done in phases:
l.a. Phase 1- Pilot sites or selected DOH licensed clinical laboratories
identified by the program in coordination with NRL-SLH/SACCL, for
the first three (3) years.
1.b Phase 2 — All private and public or government owned DOH licensed
clinical laboratories identified by DPCB in coordination with NRL-
SLH/SACCL.
_

2. The CrCL shall be headed by a Board Certified Clinical Pathologist trained in

rHIVda.

3. There shall be at least (1) one full-time Registered Medical Technologist with
valid HIV proficiency and rHIVda training certificates.

4. For initial application, complete documentary requirements shall consist of the

following:
a. Letter of intent addressed to Director IV of HFSRB or Center for Health
Development (CHD);
b. Notarized completely accomplished application form (downloadable at
[email protected]);
c. Notarized list of personnel, including photocopies of valid PRC
identification card and valid HIV proficiency training certificate from
NRL-SLH/SACCL;
d. List of equipment with specifications, reagents, and supplies;
e. For clinical laboratories with existing LTO as HIV screening testing
laboratories, current Certificate of Performance (with a passing mark) in
the National External Quality Assessment Scheme (NEQAS) for HIV
conducted by NRL-SLH/SACCL;
 f. Certificate from the NRL-SLH/SACCL
or its designated regional
counterpart, as “Certified rHIVda Confirmatory Laboratory”’;
g. Acopy of official receipt.

. Annual renewal of DOH-LTO CrCL shall follow the annual cut-off dates as
prescribed in A.O. no. 2019-0004 dated April 30, 2019, titled “Guidelines on
the Annual Cut-off Dates for Receipt of Complete Applications for Regulatory
Authorizations Issued by the Department of Health.”

. The following shall be submitted for the renewal of DOH-LTO CrCL:

a. Completely filled out and notarized application form for renewal of
DOH-LTO CrCL;
b. Notarized list of personnel, including photocopies of valid PRC
identification card, valid HIV proficiency and rHIVda training
certificates from NRL-SLH/SACCL;
c. List of equipment with specifications, reagents, and supplies;
d. Certificate of Performance (with a passing mark) in NEQAS for
rHIVda
conducted by NRL-SLH/SACCL;
e. Certificate from the NRL-SLH/SACCL or its designated regional
counterpart, as “Certified rHIVda Confirmatory Laboratory”;
f. Proof of implementation of Internal Quality Assurance such as policies,
protocols, records of quality control results and control values assigned.
g. Acopy of official receipt.

. Upon evaluation of the application, the HFSRB or CHD-RLED shall

schedule
the inspection of the CrCL to check full compliance based on the current
assessment tool for licensing a clinical laboratory.

. If fully compliant, a DOH-LTO shall be issued

to the health facility.
. If not fully compliant, the CrCL shall be given thirty (30) days to comply.
However, in the event that the applicant cannot comply within the given period,
the application shall be automatically denied and the payment shall be forfeited.

III. Monitoring
The HFSRB or CHD-RLED may conduct unannounced monitoring visits to check for
the continuous compliance of the clinical laboratory, including the CrCL, to the minimum
licensing standardssetforth by the Department.

The NRL-SLH/SACCL orits designated regional counterpart, shall have a separate

monitoring activity to ensure that the CrCL is compliant to the NRL-SLH/SACCL’s criteria.

IV. Quality Assurance

. The CrCL shall participate in the annual rH[Vda NEQAS implemented by the
NRL-SLH/SACCL.
 Failure to participate or unsatisfactory ratings in NEQAS shall be a ground for
revocation of DOH-LTO CrCL.

V. Reports

1. All official confirmatory test results shall ONLY be released to the referring
facility by the NRL-SLH/SACCL or by its
designated certified CrCL. (A.O. No.
2017-0019)

The laboratory report form issued to the clients shall bear the name of
institution/laboratory, laboratory number, name of patient and/or code of the
patient, age, sex, date of specimen collected, requesting physician, assay result
(name of kit and lot number used) and, name and signature of the analyst and
head of the laboratory. (Please see attached Annex A)

3. The CrCL shall maintain and ensure the confidentiality of all records.

VI. Violations

Violations of the guidelines stated herein, and related policies or laws shall be the basis
for suspension/revocation of the DOH-LTO.

VII. Appeal

Any CrCL or
any of
its personnel not amenable with the decision of the HFSRB/CHD-
a notice of appeal to the Health Regulations Team; serve a copy of the notice
RLED may file
of appeal to the HFSRB/CHD-RLED within fifteen (15) days, after receipt of notice of
decision. Thereupon, the HFSRB/CHD-RLED shall
promptly certify and file a copy of the
decision including the transcript of hearings on which the decision is based to the Office of the
Secretary for review. The decision of the Office of the Secretary shall be final and executory.

VIII. Validity

The DOH-LTO shall be valid for one (1) year.

IX. Effectivity

This Order shall take effect immediately.

By Authority of the Secretary of Health:

rorkin
Undersegretary of Health
Health Regulations Team
 ANNEX A

Institution
Name of Institution/Laboratory
Logo Address
Contact no., email address

rHiVda RESULT
LABORATORY NUMBER

Name: DELA CRUZ, JUAN Date of Collection: 06/01/2019

Age: 24 Specimen Type: Serum

Sex: Male Source: walk-in

HIV TEST

Test # Date Performed Name of Kit Lot # Result

Test! 06/01/2019 SD Bioline 1/2 3.0 01234 REACTIVE

Test II 06/01/2019 Alere Determine HIV 1/2 11567M REACTIVE

Test It1 06/01/2019 Bio-Rad Geenius HIV 1/2 891AB REACTIVE

Final Interpretation: POSITIVE for HIV Antibodies

Remarks: Fill out DOH-EB Reporting form B/C and submit to the Department of Health -Epidemiology
Bureau.

Analyzed by: Reviewed by: Noted by:

Medical Technologist Chief Medical Technologist Pathologist

PRC License Number PRC License Number PRC License Number

Form Control No. Effectivity Date: ,lssue #:___ Rev. Date Released: 06/01/2019
COMPUTER GENERATED FORM Date Printed: 06/01/2019
 ANNEX A

Name of Institution/Laboratory
ee Address
Contact no., email address

rHiVda RESULT
LABORATORY NUMBER

Name: DELA CRUZ, JUAN Date of Collection: 06/01/2019

Age: 24 Specimen Type: Serum

Sex: Male Source: walk-in

HIV TEST

Test # Date Performed Name of Kit Lot # Result

Test! 06/01/2019 SD Bioline 1/2 3.0 01234 REACTIVE

Test !1 06/01/2019 Alere Determine HIV 1/2 11567M REACTIVE

Test I11 06/01/2019 Bio-Rad Geenius HIV 1/2 891AB REACTIVE

Final Interpretation: |
POSITIVE for HIV Antibodies

Remarks: Fill out DOH-EB Reporting form B/C and submit to the Department of Health -Epidemiology
Bureau.

Analyzed by: Reviewed by: Noted by:

Medical Technologist Chief Medical Technologist Pathologist

PRC License Number PRC License Number PRC License Number

Form Control No. Effectivity Date: ,lssue #:_ Rev. Date Released: 06/01/2019
COMPUTER GENERATED FORM Date Printed: 06/01/2019