Amendment to the Administrative Order No. 2020-0014 "Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines"

May 20, 2020

DOH ADMINISTRATIVE ORDER NO. 2020-0014-A

 

The Department of Health Administrative Order (A.O.) No. 2020-0014 dated April 7, 2020, titled "Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines" was issued as a strategy to expand the testing capacity for SARS-CoV-2 in the country. It sets the standards that will ensure maintenance of quality and safety at all times.

Initially, only Real Time Reverse Transcriptase Polymerase Chain Reaction (rRT-PCR) is the acceptable diagnostic method to detect SARS-CoV-2, the causative agent of COVID-19. With the demand for more testing to be done and faster releasing of results, new diagnostic platforms with a shorter turnaround time have emerged, such as the cartridge-based technology or the automated platforms for nucleic acid based technology, and are now considered as a means to augment the current testing capacity. Moreover, innovative ways of setting up COVID-19 testing laboratories are being proposed by stakeholders to help the government address the demand for more testing.

To include the use of these new platforms as acceptable methods in detecting SARS-CoV-2 and the different models or designs of COVID-19 testing laboratories, such as but not limited to pop-up labs which may be the modular types laboratories or container vans converted into labs, etc., the following additional guidelines are hereby issued to supplement A.O. No. 2020-0014.

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V. IMPLEMENTING MECHANISMS

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Under Section V.A.7.

7. The COVID-19 testing laboratory shall be supervised by a Board Certified Clinical Pathologist, with training in Molecular Laboratory Diagnosis. aDSIHc

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The aforementioned is hereby amended to read as follows:

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7. The COVID-19 testing laboratory shall be supervised by a Board Certified Clinical Pathologist.

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Under Section V.A.13.

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13. In reporting of results, COVID-19 testing laboratories shall follow DOH Department Memorandum No. 2020-0110 dated March 13, 2020, titled "Directive to All Public and Private hospitals and Healthcare Facilities on Reporting Coronavirus Disease (COVID-2019)"

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The aforementioned is hereby amended to read as follows:

13. The reporting of results in COVID-19 testing laboratories shall be in accordance with the following issuances:

a) Republic Act No. 11332, also known as the "Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act"

b) A.O. No. 2020-0013 dated April 9, 2020, titled Revised Administrative Order No. 2020-0012 "Guidelines for the Inclusion of the Coronavirus Disease 2019 (COVID-19) in the List of Notifiable Diseases for Mandatory Reporting to the Department of Health" dated March 17, 2020.

c) Department Memorandum No. 2020-0110 dated March 13, 2020, titled "Directive to All Public and Private hospitals and Healthcare Facilities on Reporting Coronavirus Disease (COVID-2019)"

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Under Section V.B.2.A.

A. PERSONNEL

There shall be an adequate number of personnel, depending on the workload.

1. The minimum number of personnel shall be SEVEN (7), but may be more depending on the workload, and shall be composed of the following:

a) One (1) Board Certified Clinical Pathologist with knowledge in Infectious Diseases and training in Molecular Laboratory Diagnosis;

b) Three (3) Full-time Analysts per eight (8) hour shift, which shall be composed of EITHER three (3) Registered Medical Technologists OR two (2) Registered Medical Technologists and any allied health professionals with a Bachelor's degree relevant to the job, and with knowledge, experience, and skills in molecular biology techniques, such as Molecular Biology and Biotechnology, Biology, Applied Biology, Biochemistry, and Microbiology; ETHIDa

c) One (1) Full-time Laboratory Aide per eight (8) hour shift;

d) One (1) Full-time Receptionist per eight (8) hour shift; AND

e) One (1) Full-time Encoder per eight (8) hour shift.

2. The laboratory staff shall have the following trainings:

a) Fundamentals of Biosafety and Biosecurity, which shall cover Biological Risk Assessment, Mitigation Controls (engineering, practices and procedures, administrative), Personal Protective Equipment, specimen transport, waste management, decontamination and disposal, and Emergency Responses (biological spill drill), AND

b) Molecular Diagnostics.

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The aforementioned is hereby amended to read as follows:

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A. PERSONNEL

There shall be an adequate number of personnel, depending on the workload.

1. The following are the minimum number of personnel, but may be more depending on the workload, and shall be composed of:

A. For COVID-19 laboratories performing rRT-PCR, the minimum number is SEVEN (7)

a) One (1) Board Certified Clinical Pathologist;

b) Three (3) Full-time Analysis per eight (8) hour shift, which shall be composed of EITHER three (3) Registered Medical Technologists OR two (2) Registered Medical Technologists and any allied health professionals with a Bachelor's degree relevant to the job, and with knowledge, experience, and skills in molecular biology techniques, such as Molecular Biology and Biotechnology, Biology, Applied Biology, Biochemistry, and Microbiology;

c) One (1) Full-time Laboratory Aide per eight (8) hour shift;

d) One (1) Full-time Receptionist per eight (8) hour shift; AND

e) One (1) Full-time Encoder per eight (8) hour shift.

B. For COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2, the minimum number shall be FOUR (4)

a) One (1) Board Certified Clinical Pathologist;

b) One (1) Full-time Registered Medical Technologist as Analysts per eight (8) hour shift for every (2) machines; cSEDTC

c) One (1) Full-time Laboratory Aide per eight (8) hour shift for every (4) machines; AND

d) One (1) Full-time Encoder per eight (8) hour shift for every (4) machines.

2. The laboratory staff shall have the following trainings:

a) Fundamentals of Biosafety and Biosecurity, which shall cover Biological Risk Assessment, Mitigation Controls (engineering, practices and procedures, administrative), Personal Protective Equipment, specimen transport, waste management, decontamination and disposal, and Emergency Responses (biological spill drill);

 The abovementioned trainings, which can be provided in-house, shall be required for Laboratory Aide, Receptionist and Encoder.

b) Molecular Laboratory Diagnosis or Molecular Laboratory Diagnostics for Clinical Pathologist and Analysts.

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Under Section V.B.2.B.

B. PHYSICAL FACILITIES

COVID-19 testing laboratories shall have adequate and appropriate areas to safely, effectively and efficiently provide the services to clients.

1. There shall be a dedicated space for each of the following activities:

a) Specimen reception;

b) Virus inactivation and nucleic acid extraction (Pre-PCR);

c) Reagent storage and handling;

d) PCR; AND

e) Clerical activities.

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3. The prototype floor plan and the floor plan checklist for constructing a COVID-19 testing laboratory shall be used as references in constructing the testing laboratory. (ANNEX D1 and ANNEX D2)

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The aforementioned is hereby amended to read as follows:

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B. PHYSICAL FACILITIES

COVID-19 testing laboratories shall have adequate and appropriate areas to safely, effectively and efficiently provide the services to clients.

1. There shall be a dedicated space for each of the following activities:

A. For COVID-19 laboratories performing rRT-PCR

a) Specimen reception;

b) Virus inactivation and nucleic acid extraction (Pre-PCR);

c) Reagent storage and handling;

d) PCR; AND

e) Clerical activities. SDAaTC

B. For COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2

a) Specimen reception;

b) Specimen Processing; AND

c) Clerical Activities

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3. COVID-19 testing laboratories shall be in accordance with the prototype floor plan and floor plan checklist prior to construction of the laboratory.

The following are the references:

a. Prototype floor plan

1) ANNEX D1 — for COVID-19 laboratories performing manual RNA extraction

2) ANNEX D3 — for COVID-19 laboratories using automated RNA extraction machines

3) ANNEX D4 — for COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2

4) ANNEX D5 — for COVID-19 Pop-Up testing laboratories

b. Floor plan checklist

1) ANNEX D2 — for COVID-19 laboratories performing Real Time Reverse Transcriptase Polymerase Chain Reaction (rRT-PCR)

2) ANNEX D6 — for COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2

c. General Notes — ANNEX D7

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Under Section V.B.3.

3. EQUIPMENT AND INSTRUMENTS

COVID-19 testing laboratories shall have available and operational equipment and instruments appropriate and consistent to the designated areas. (Please refer to Annex A — Assessment Tool for Licensing a COVID-19 testing laboratory)

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The aforementioned is hereby amended to read as follows:

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3. EQUIPMENT AND INSTRUMENTS

COVID-19 testing laboratories shall have available and operational equipment and instruments appropriate and consistent to the designated areas.

For COVID-19 laboratories performing rRT-PCR — Please refer to Annex A1 (Assessment Tool for Licensing a COVID-19 testing laboratory)

For COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2 — Please refer to Annex A2 (Assessment Tool for Licensing a COVID 19 testing laboratory using the cartridge-based technology to detect SARS-CoV-2). acEHCD

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Under Section V.B.5.

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1. Pass the Proficiency Testing (PT) given by RITM prior to its operation.

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The aforementioned is hereby amended to read as follows:

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1. Pass the Proficiency Testing (PT) or its equivalent given by RITM prior to its operation.

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Under Section V.B.9.4. and 6

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4. The linelist of POSITIVE specimens shall be e-mailed to the following:

a) Usec. Myrna Cabotaje — [email protected]

b) DOH Epidemiology Bureau — [email protected]

c) Director of the Hospital

d) Appropriate Regional Epidemiology and Surveillance Unit (RESU)

c) Dr. Celia Carlos — [email protected]

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6. The linelist of NEGATIVE specimens shall be e-mailed to the following:

a) DOH Epidemiology Bureau — [email protected]

b) Director of the Hospital

c) Appropriate Regional Epidemiology and Surveillance Unit (RESU)

d) Dr. Celia Carlos — [email protected]

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Submission of Linelist of POSITIVE and NEGATIVE specimens shall be at the Health Regulation Team instead of RITM, the aforementioned is hereby amended to read as follows:

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4. The linelist of POSITIVE specimens shall be e-mailed to the following:

a) Usec. Maria Rosario Singh-Vergeire — [email protected]

b) Usec. Myrna Cabotaje — [email protected]

c) DOH Epidemiology Bureau — [email protected]

d) Director of the Hospital

e) Appropriate Regional Epidemiology and Surveillance Unit (RESU)

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6. The linelist of NEGATIVE specimens shall be e-mailed to the following:

a) Usec. Maria Rosario Singh-Vergeire — [email protected]

b) DOH Epidemiology Bureau — [email protected]

c) Director of the Hospital SDHTEC

d) Appropriate Regional Epidemiology and Surveillance Unit (RESU)

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Under Section VI.1.b.2.c

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c. Notarized list of personnel, including photocopies of valid PRC identification card, valid COVID-19 proficiency a from RITM, and copy of certificates of all necessary trainings;

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The aforementioned provisions are hereby amended to read as follows:

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c. Notarized list of personnel, including photocopies of valid PRC identification card, valid COVID-19 proficiency training certificate or its equivalent from RITM, and copy of certificates of all necessary trainings;

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Under Section VI.4

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The following statement shall be inserted as items (3):

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3. Proficiency Testing (PT) fees shall follow the Schedule of Fees currently prescribed by RITM.

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Under Section VII.3.b.

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b. To inspect and issue DOH-LTO CHD-RLEDs for non-hospital based COVID-19 testing laboratories and for COVID-19 testing laboratories based in level 1 general hospitals.

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To omit the term "CHD-RLEDs" in the abovementioned provision and this shall be read as follows:

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b. To inspect and issue the DOH-LTO for non-hospital based COVID-19 testing laboratories and for COVID-19 testing laboratories based in level 1 general hospitals.

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VII. TRANSITORY PROVISIONS

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Under Section VIII.b.

b) All initial application shall be submitted to HFSRB whether hospital-based or nonhospital-based. However, renewal for COVID-19 testing laboratories in based in level 1 hospitals and non-hospital based shall be at their respective CHD-RLED.

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e) Team to conduct inspection or monitoring shall come from HFSRB and RITM or its duly recognized/authorized 3rd party assessors. AScHCD

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The aforementioned provisions are hereby amended to read as follows:

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b) All initial application shall be submitted to HFSRB whether hospital-based or nonhospital-based. However, HFSRB may delegate the inspection of COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2 to CHD-RLEDs. Renewal for COVID-19 testing laboratories based in level 1 hospitals and nonhospital-based shall be at their respective CHD-RLED.

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e) Team to conduct inspection or monitoring shall come from HFSRB and RITM or its duly recognized/authorized 3rd party assessors. However, inspection of COVID-19 laboratories using the cartridge-based technology to detect SARS-CoV-2 may be delegated to teams from CHD-RLEDs and RITM or its duly recognized/authorized 3rd party assessors.

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The following statements shall be inserted as items (f), (g), (h), and (i):

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f) The DOH-LTO of COVID-19 laboratories of the National Tuberculosis Control Program which performs SARS-CoV-2 testing shall be valid for three (3) months but may be extended, if warranted after evaluation.

g) The details as to the additional standards and requirements for new platforms deemed acceptable to detect SARS-CoV-2 shall be in the Assessment Tool for that particular platform, and shall be issued in the form of a Department Circular as an Annex of AO 2020-0014.

h) The DOH-LTO fee shall be waived.

i) RITM shall bear the cost of up to two (2) PT panels. However, if the applicant failed to pass the PT after two (2) attempts, the analyst shall undergo re-training and the laboratory shall pay the corresponding fees for the succeeding panels to RITM.

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XI. n REPEALING CLAUSE

All other provisions of Administrative Order No. 2020-0014 shall remain in effect and provisions/issuances inconsistent or contrary to this Order are hereby rescinded or modified accordingly.

XII. SEPARABILITY CLAUSE

In the event that any provision or part of this issuance is declared unconstitutional or rendered invalid by any court of law or competent authority, the portions not affected thereby shall remain in full force and effect.

XIII. EFFECTIVITY

This Order shall take effect immediately. AcICHD

(SGD.) FRANCISCO T. DUQUE III, MD, MScSecretary of Health

ANNEX A1

Assessment Tool for Licensing a COVID-19 Testing Laboratory

ANNEX A2

Assessment Tool for Licensing a COVID-19 Testing Laboratory

 

ANNEX D1

COVID-19 Testing Laboratory Performing Manual RNA Extraction rRt-PCR

 

ANNEX D2

Checklist for Review of Floor Plans

 

ANNEX D3

COVID-19 Testing Laboratory

 

ANNEX D4

COVID-19 Testing Laboratory

 

ANNEX D5

COVID-19 Pop-Up Testing Laboratory

 

ANNEX D6

Checklist for Review of Floor Plans

 

ANNEX D7

General Notes

 

n Note from the Publisher: Copied verbatim from the official copy. Irregular numerical sequence.