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Guidelines in Securing Remote Collection Permit 8-5-2021

1. Only licensed clinical laboratories can apply for a Remote Collection Permit to collect specimens at non-clinical sites like schools and offices. 2. Specimens must be properly handled and transported with blood serum separated within 4 hours and urine/stool refrigerated within 1 hour of collection. 3. The remote collection site must be within 100km of the licensed clinical laboratory and permits are valid for a single collection date.

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Maureen Pascua Mangabat
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2K views2 pages

Guidelines in Securing Remote Collection Permit 8-5-2021

1. Only licensed clinical laboratories can apply for a Remote Collection Permit to collect specimens at non-clinical sites like schools and offices. 2. Specimens must be properly handled and transported with blood serum separated within 4 hours and urine/stool refrigerated within 1 hour of collection. 3. The remote collection site must be within 100km of the licensed clinical laboratory and permits are valid for a single collection date.

Uploaded by

Maureen Pascua Mangabat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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A.O. No.

2021 - 0037
ANNEX E
Republic of the Philippines
Department of Health
HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT


FOR CLINICAL LABORATORIES

1. Only DOH-licensed clinical laboratories (CL), without mobile clinical laboratory (MCL)
shall be required to apply for Remote Collection Permit-CL (RCP-CL).

2. Remote collection can only be done in the following non-clinical laboratory settings such
as but not limited to:
2.1. Schools;
2.2. Offices;
2.3. Churches; and
2.4. Other areas used for community-based activities.

3. The remote collection facility should have a proper area for specimen collection (e.g. clean
toilet for urine and stool collection).

4. Only employed Registered Medical Technologists (RMTs) of the applicant’s CL shall be


allowed to collect blood samples/specimens.

5. The activity at the remote collection facility shall only last for four (4) to six (6) hours.

6. No testing or processing of specimens shall be done in the temporary collection facility.

7. Specimens should be properly handled and transported.


7.1. Samples for routine urinalysis and routine fecalysis shall be stored at refrigerated
temperature within one (1) hour from the time of collection.
7.2. The serum from blood samples for chemistry must be separated within four (4) hours
from the time collection.

8. The remote collection facility shall be located within the same region, at a maximum of
one hundred (100) kilometre radius, from the address of DOH licensed CL.

9. RCP-CL shall be secured from the DOH at least seven (7) working days prior to the
scheduled activity.

10. RCP-CL shall be secured from the DOH regulatory office in accordance with DOH
guidelines.

11. RCP-CL shall be signed by the Director IV of HFSRB or Center for Health Development
(CHD), or his designate.

12. The following are the documentary requirements:

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12.1. Letter of request, signed by the Head of Clinical Laboratory, to conduct remote
collection with the following information:
12.1.1. Name of facility with DOH-LTO number
12.1.2. Address of facility
12.1.3. Date of collection
12.1.4. Time of collection
12.1.5. Venue
12.1.6. Estimated number of clients
12.1.7. Specimen to be collected

12.2. Notarized Memorandum of Agreement or contract between the contracting parties.


12.3. Technical or operational procedures for remote collection including specimen
handling and transportation.

12.4. List of laboratory supplies/equipment to be used during remote collection including


the transport materials.

13. A remote collection permit fee of Php500.00 for each site shall be collected from the
clinical laboratory.

14. The RCP-CL shall be valid only up to the date of collection. In case of failure to conduct
the collection at the specified date, the laboratory shall inform the HFSRB or CHD-
Regulation, Licensing and Enforcement Division (CHD-RLED) in writing, at least within
48 hours before the scheduled date of remote collection and shall be informed of the new
schedule which should be within the validity period. Otherwise, another RCP-CL shall be
secured.

13. A copy of the RCP-CL shall be posted in conspicuous area of the remote collection facility.

16. The clinical laboratory shall maintain records of all remote collection performed.

17. The HFSRB or CHD-RLED may inspect the remote collection site prior to the issuance of
the permit or monitor during the actual collection.

18. In case of failure to conduct the collection at the specified date, the laboratory shall inform
the HFSRB or CHD-RLED in writing, at least within 48 hours before the scheduled date
of remote collection, and shall be informed of the new schedule which should be within the
validity period. Otherwise, another RCP-CL shall be secured.

19. Home service blood collection shall be exempted from securing RCP-CL provided, that it
of collection must be within (1) hour travel
is upon the patient’s doctor request, and the area
time, under normal circumstances, from the licensed clinical laboratory. To ensure proper
specimen collection and handling, provision nos. 4, 5, 7.1, and 8 of this guidelines should
be followed.

20. Violations of the guidelines stated herein, and related policies or laws shall be the basis for

“*
suspension/revocation of the RCP-CL and the LTO of the main clinical laboratory.

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