Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines

April 7, 2020

DOH ADMINISTRATIVE ORDER NO. 2020-0014

 

I. RATIONALE/BACKGROUND

The current pandemic, Corona Virus Disease 2019 (COVID-19), has focused the attention on the scarcity of capable testing facilities. Local data, as of April 1, 2020, showed that there are 227 additional new confirmed cases with positive test results, bringing the number to 2,311 infected cases in the country, with 50 individuals recovering from the disease and 96 deaths reported.

The standard testing procedure for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, is the Real Time Reverse Transcriptase-Polymerase Chain Reaction (rRT-PCR) as recommended by the World Health Organization (WHO). Its sensitivity to detect the presence of the virus early on will result in the immediate enforcement of precautionary measures, thus curbing the further transmission of the disease. It is a highly delicate process involving several steps to detect RNA viruses. As such, handling of specimens requires strict adherence to biosafety and biosecurity guidelines by WHO.

There are only few molecular laboratories in the country, and their services include genotyping, identifying mutation defects, deoxyribonucleic acid (DNA) sequencing and paternity testing. However, only the Research Institute for Tropical Medicine (RITM) has the laboratory recognized by the WHO as capable of doing COVID-19 testing.

These guidelines are being issued to set the standards in licensing COVID-19 testing laboratories as a strategy to expand testing capacity, to have more capable laboratories, and at the same time ensuring that quality and safety are maintained.

II. OBJECTIVE

This Order aims to ensure the safety of personnel and the general public, as well as the quality and accuracy of the generated reports of COVID-19 testing laboratories.

III. SCOPE

This Order shall apply to all private and government COVID-19 testing laboratories in the Philippines, whether hospital-based or non-hospital-based.

IV. DEFINITION OF TERMS

1. Applicant — an individual, partnership, corporation or association seeking a license to operate to maintain a COVID-19 testing laboratory.

2. COVID-19 testing laboratory — a health facility where COVID-19 testing (SARS-CoV-2 detection) is done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of disease.

3. Department of Health-License to Operate (DOH-LTO) — a formal authorization issued by the DOH through the Health Facilities and Services Regulatory Bureau (HFSRB) to an individual, partnership, corporation or association seeking to perform SARS-CoV-2 detection in a COVID-19 testing laboratory in compliance with the requirements prescribed in this Order.

4. DOH-Permit to Construct — a permit issued by DOH through HFSRB to an applicant who will establish and operate a COVID-19 testing laboratory, upon compliance with required documents set forth in this Order prior to actual construction of the said facility. A DOH-PTC is also required for health facility with substantial alteration, expansion, renovation, etc. It is a prerequisite for License to Operate.

5. Letter of Recommendation — a formal endorsement issued by RITM or its duly recognized/authorized assessors upon full compliance of the applicant with their requirements, which includes proficiency testing of the laboratory.

6. Real Time Reverse Transcriptase-Polymerase Chain Reaction (rRT-PCR) — a PCR test designed to detect, measure and study RNA viruses. It allows a single strand of RNA to be translated into a complementary DNA which will then be amplified following the routine PCR method.

V. IMPLEMENTING MECHANISMS

A. GENERAL GUIDELINES

1. COVID-19 testing shall only be done in a DOH licensed COVID-19 testing laboratory.

2. The DOH-LTO for a COVID-19 testing laboratory shall only be issued upon full compliance to the standards and requirements of RITM and HFSRB/CHD-RLED.

3. The DOH-LTO of a hospital-based COVID-19 testing laboratory shall be subsumed in the LTO of the hospital.

4. For non-hospital-based COVID-19 testing laboratory:

a. With existing licensed general clinical laboratory — the DOH-LTO of COVID-19 testing laboratory shall be subsumed in the current LTO of the general clinical laboratory.

b. For facilities with Certificate of Registration by the DOH or without any DOH regulatory authorization — the DOH-LTO of COVID-19 testing laboratory shall be issued as clinical laboratory with limited service capability.

5. The COVID-19 testing laboratory shall be a separate unit, with its own designated working room.

6. Strict adherence to biosafety and biosecurity guidelines, as prescribed by the RITM based on WHO recommendations, shall be strictly enforced.

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

8. The staff shall have the appropriate trainings prescribed by RITM.

9. COVID-19 testing laboratories shall have a Manual of Operations, which shall include, but not limited to, the standard operating procedures being implemented in the facility; policies and procedures on biosafety and biosecurity, handling and transporting of specimens; disposal of infectious wastes; Infection Prevention and Control; records management; preventive maintenance of the facility and the equipment; and copies of relevant laws and DOH issuances.

10. COVID-19 testing laboratories shall only use FDA registered testing kits, reagents and devices.

11. COVID-19 testing laboratories shall adhere and ensure strict compliance with infection prevention and control guidelines.

12. COVID-19 testing laboratories shall be strictly prohibited from outsourcing of examinations.

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 Corona Virus Disease (COVID-2019)."

14. COVID-19 testing laboratories shall follow the standards, criteria and requirements prescribed in the DOH Assessment Tool for Licensing a COVID-19 testing laboratory (ANNEX A), RITM's Biosafety and Laboratory Assessment Tool (ANNEX B1 and ANNEX B2), and accomplish the WHO risk assessment form (ANNEX C).

B. SPECIFIC GUIDELINES

1. CLASSIFICATION OF COVID-19 TESTING LABORATORIES

A. According to Ownership

a) Government — created by law. A government facility may be under the national government, DOH, local government unit (LGU), Department of National Defense (DND), Philippine National Police (PNP), Department of Justice (DOJ), State Universities and Colleges (SUCs), Government Owned and Controlled Corporations (GOCCs) and others.

b) Private — owned, established and operated with funds through donation, principal, investment or other means by any individual corporation, association or organization. A private health facility may be a single proprietorship, partnership, corporation, cooperative, foundation, religious, non-government organization and others.

B. According to Institutional Character

a) Hospital Based — within the premises or the compound of the hospital. It may be a part of the general clinical laboratory, but with a specific designated room distinct from the main laboratory.

b) Non-hospital-based — located outside the premises or the compound of a hospital and independently functioning on its own.

2. STANDARDS

COVID-19 testing laboratories shall be organized to provide safe, quality and effective and efficient services.

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;

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.

3. The staff shall be proficient on Molecular Diagnostic Techniques.

4. The staff shall undergo fit testing for respirator with at least 95% efficiency, e.g., N95 mask.

5. The staff shall have an annual medical examination including influenza vaccination.

6. The staff shall have continuing updated trainings on biosafety and biosecurity, new techniques and technologies, among others.

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.

2. Unidirectional workflow following the abovementioned activities shall be maintained at all times.

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)

4. Controlled and adequate ventilation with the prescribed air changes per hour shall be maintained for each specific area.

5. Adequate lighting shall be provided in all areas.

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) They shall comply with or have:

1. Required equipment, supplies and reagents are organized and appropriately located in their designated areas.

2. There shall be a documented inventory of equipment, supplies, reagents and control.

3. Periodic calibration and maintenance of equipment are carried out and duly documented.

4. The equipment shall undergo daily cleaning and maintenance.

4. SERVICE CAPABILITY

COVID-19 testing laboratories shall ensure that the services delivered to patients comply with the standards in the Assessment Tool for Licensing a COVID-19 testing laboratory (ANNEX A) and other relevant issuances. They must have:

1. Manual of Procedures and Work Instructions on the laboratory techniques.

2. Accomplished WHO Risk Assessment form.

3. Standard Operating Procedures of the facility, which shall include, but not limited to, Policies on Biosafety and Biosecurity; proper use of Personal Protective Equipment; Specimen Storage, Transport and Disposal; Waste Management; Emergency Response System (accidents, medical emergencies, spills, natural disasters, facility containment).

4. A copy (soft or hard copy) of RITM Biorisk Management Office Interim Biosafety Guidelines for Laboratories Handling and Testing SARS-COV-2 (COVID-19) Specimen Version 2 or its latest version.

5. QUALITY IMPROVEMENT ACTIVITIES

COVID-19 testing laboratories shall establish and maintain a system for continuous quality improvement activities, and be able to:

1. Pass the proficiency testing given by RITM prior to its operation.

2. Identify the many potential risks in the laboratory processes and document the recommendations to mitigate such risks.

3. Participate and pass in the National External Quality Assessment Scheme (NEQAS) given by RITM.

6. INFORMATION MANAGEMENT

Every COVID-19 testing laboratory shall maintain a system of communication, recording, reporting and releasing of the patient's results, in adherence to Republic Act (R.A.) No. 10173 also known as the "Data Privacy Act of 2012" AND R.A. No. 11332 also known as the "Mandatory Reporting of Notifiable Diseases and Health Events of Public Health Concern Act."

There shall be logbook or record for:

1. Receiving of specimen with laboratory request from the health facility or attending physician.

2. Specimen storage, transport, and disposal.

3. Releasing of results to the DOH Epidemiology Bureau (EB) and DOH Regional Epidemiologic Surveillance Unit (RESU).

4. Sentinel/adverse events.

5. Preventive and corrective maintenance of equipment and instruments.

6. Maintenance and monitoring of health facility.

7. ENVIRONMENTAL MANAGEMENT

COVID-19 testing laboratories shall ensure that the environment is safe for its patients and staff, including the general public.

1. There shall be a written plan and program of proper disinfection and preventive maintenance of the facility.

2. There shall be appropriate signage, and that only authorized personnel shall be allowed entry.

3. The use of Personal Protective Equipment and adherence to Infection Control Policies shall be strictly observed.

4. There shall be procedures for the proper disposal of infectious wastes and toxic and hazardous substances in accordance with R.A. No. 6969 known as "Toxic and Hazardous Substances and Nuclear Wastes Act" and other related policy guidelines and/or issuance (e.g., DOH Healthcare Waste Management Manual).

5. There shall be a Memorandum of Agreement with infectious waste and toxic and hazardous substances hauler.

8. CONTINGENCY PLAN

Every COVID-19 testing laboratory shall have a contingency plan in case of equipment breakdown and shall have a Notarized Memorandum of Agreement (MOA) with another DOH licensed COVID-19 testing laboratory.

1. The COVID-19 testing laboratory shall inform in writing the DOH-HFSRB or CHD-RLED about the temporary suspension of their COVID-19 testing.

2. In case of equipment breakdown during the actual processing of specimens, the sample shall be immediately transported (in strict adherence to the guidelines for specimen handling and transport) to another COVID-19 testing laboratory, which they have a MOA with.

3. In the event of machine breakdown, the COVID-19 testing laboratory shall not accept specimens from any patient or referral health facility.

4. The COVID-19 testing laboratory shall inform their clients and refer them to another DOH licensed COVID-19 testing laboratory.

5. Full operation shall be restored within three (3) months.

9. RELEASE OF RESULTS

1. Results shall be signed by the medical technologist who performed the test, verified by a senior technologist, and approved by the pathologist prior to release.

2. Releasing of results shall follow the DOH guidelines.

3. The Laboratory shall submit a linelist of POSITIVE specimens following the linelist format below:

 

Name of COVID-19 Testing Laboratory:

Date of Report:

LAB ID	PATIENT NAME	AGE	SEX	HEALTH FACILITY	SPECIMEN TYPE	PCR RESULT
COVIDID-XXXX	Dela Cruz, Juan	40	M	Hospital A	NPS/OPS	SARS-CoV-2 viral RNA detected
COVIDID-XXXX	Cruz, Gabriella	60	F	Hospital B	NPS/OPS	SARS-CoV-2 viral RNA detected

 

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)

e) Dr. Celia Carlos — [email protected]

5. The Laboratory shall submit a linelist of NEGATIVE specimens following the linelist format below:

 

Name of COVID-19 Testing Laboratory:

Date of Report:

LAB ID	PATIENT NAME	AGE	SEX	HEALTH FACILITY	SPECIMEN TYPE	PCR RESULT
COVIDID-XXXX	Dela Cruz, Juan	40	M	Hospital A	NPS/OPS	SARS-CoV-2 viral RNA detected
COVIDID-XXXX	Cruz, Gabriella	60	F	Hospital B	NPS/OPS	SARS-CoV-2 viral RNA detected

 

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]

VI. PROCEDURAL GUIDELINES

1. Licensing Process

a. DOH-Permit to Construct (DOH-PTC)

1) A DOH-PTC shall be a prerequisite in the application of LTO.

2) A completely filled out application form shall be submitted to:

a. HFSRB for COVID-19 testing laboratories based in levels 2 and 3 general hospitals, and specialty hospitals;

b. CHD-RLEDs for non-hospital based COVID-19 testing laboratories and for COVID-19 testing laboratories based in level 1 general hospitals.

3) Complete applications (based on A.O. No. 2016-0042, "Guidelines in Securing a DOH-PTC") shall be processed according to the Citizen's Charter timeline.

4) Once approved, the facility owners can commence with the construction of the laboratory.

b. DOH-License to Operate (DOH-LTO)

1) Filing of complete application requirements, whether manual or online, shall be at HFSRB or CHD-RLEDs.

a. HFSRB for COVID-19 testing laboratories based in levels 2 and 3 general hospitals, and specialty hospitals;

b. CHD-RLEDs for non-hospital based COVID-19 testing laboratories and for COVID-19 testing laboratories based in level 1 general hospitals.

2) Complete documentary requirements shall consist of the following:

a. Notarized completely accomplished application form (ANNEX E);

b. A copy of approved DOH-PTC and floor plan;

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

d. List of equipment with specifications, reagents, and supplies;

e. Copy of Certificate of Product Registration (CPR) from Food and Drug Administration for all equipment, reagents and supplies;

f. Accomplished Self-Assessment Tool for Licensing a COVID-19 testing laboratory;

g. For renewal, a copy of NEQAS, Certificate of Performance with PASSING results, conducted by RITM.

3) After evaluation of the submitted documents for technical completeness and correctness, the assigned team from HFSRB/CHD-RLED shall schedule an inspection date, in coordination with the team from RITM or its duly recognized/authorized 3rd party assessors.

4) Process for Inspection (initial or renewal) shall follow Section VI. E and F of A.O. No. 2012-0012, known as "Rules and Regulations Governing the New Classification of Hospitals and Other Health Facilities in the Philippines" and the Quality Management System (QMS) guidelines of the Bureau.

5) RITM or its duly recognized/authorized 3rd party assessors shall transmit to HFSRB/CHD-RLED a Letter of Recommendation when the facility is fully compliant to the standards and requirements of RITM.

6) The DOH-LTO a COVID-19 testing laboratory shall be issued only after full compliance to the standards and requirements by HFSRB/CHD-RLED and the RITM.

7) The DOH-LTO shall be signed by the Director IV of HFSRB or CHD-RLED.

8) Processing from application to issuance of DOH-LTO shall be according to the Citizen's Charter Timeline.

2. Validity of DOH-LTO

The DOH-LTO, for both hospital-based and non-hospital-based COVID-19 testing laboratory, shall be valid for one (1) year. Annual renewal of DOH-LTO COVID-19 testing laboratory 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."

3. Monitoring

HFSRB/CHD-RLED together with RITM or its duly recognized/authorized 3rd party assessors may conduct unannounced visits to ensure continuous compliance to the standards.

4. Fees

1. The DOH-LTO fee shall follow the schedule of fees currently prescribed by the DOH.

2. The applicant, upon filing the application, shall pay the corresponding fee to the DOH Cashier/RO Cashier.

VII. ROLES AND RESPONSIBILITIES

1. Health Facilities and Services and Regulatory Bureau

a. To strictly enforce the provisions of this Order.

b. To set standards for the regulation of health facilities including COVID-19 testing laboratories.

c. To create/modify inspection and monitoring tools from time to time.

d. To disseminate regulatory policies, standards and forms for information and guidelines to the DOH-CHDs.

e. To provide consultation and technical assistance to stakeholder, including regulatory officers from the DOH-CHDs in regulation of COVID-19 testing laboratories.

f. To inspect and issue DOH-LTO for COVID-19 testing laboratories based in levels 2 and 3 general hospitals, and specialty hospitals.

g. To conduct unannounced monitoring visits to check for continuous compliance of DOH-LTO.

h. To promptly respond to complaints relative to the operation of COVID-19 testing laboratories.

2. Research Institute of Tropical Medicine (RITM) — the reference laboratory for COVID-19 testing recognized by the World Health Organization (WHO)

a. To provide laboratory reference/referral services for COVID-19.

b. To train laboratory personnel.

c. To maintain quality assurance program for COVID-19 testing laboratories through proficiency testing.

d. To perform technical evaluation of reagents and diagnostic kit.

e. To train & authorize 3rd party trainer and/or assessors.

3. Center for Health Development-Regulation, Licensing, and Enforcement Division (CHD-RLED)

a. To strictly enforce the provisions of this Order.

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.

c. To conduct unannounced monitoring visits to check for continuous compliance of COVID-19 testing laboratories.

d. To submit report on Suspension/Revocation/Cease and Desist Order issued on COVID-19 testing laboratories as soon as possible.

e. To promptly respond to complaints relative to the operation of COVID-19 testing laboratories.

4. Epidemiology Bureau and its Regional Epidemiology Surveillance Units

a. Collect and aggregate data from COVID-19 testing laboratories.

b. Analyze and report data collected from COVID-19 testing laboratories.

VIII. TRANSITORY PROVISIONS

In view of the urgency of the need for more COVID-19 testing laboratories:

a) The DOH-PTC application shall be waived for existing facilities and shall submit an as built floor plan, in lieu of the DOH-PTC which reflects the workflow on the prototype reference plan.

b) All initial application shall be submitted to HFSRB whether hospital-based or non-hospital-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.

c) The technical assistance done by DOH, RITM or its duly recognized/authorized 3rd party assessors may serve as the initial inspection visit. As such, compliance to the recommendations done then and to the Assessment Tool for licensing a COVID-19 testing laboratory may preclude another visit prior to the issuance of DOH-LTO. A re-visit may be done by the team, if so warranted.

d) The laboratories already assessed by the team from HFSRB/CHD-RLEDs are advised to apply for a DOH-LTO, using these guidelines as reference.

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

IX. VIOLATION AND SANCTIONS

COVID-19 testing laboratories and/or the responsible personnel thereof, found to be violating any provision of these rules and regulations, related issuances, and other applicable policy guidelines, shall be penalized under the existing laws, which may include suspension or revocation of DOH-LTO.

X. APPEAL

Any hospital or health facility aggrieved by the decision of the Director IV of HFSRB, or in his/her absence or unavailability or when delegated, the Director III of HFSRB, may, within ten (10) days after receipt of the notice of decision, file a notice of appeal to the head of the Health Regulation Team (HRT). All pertinent documents and records of the applicant shall then be elevated by the HFSRB to the HRT. The decision of the head of the HRT, if still contested, may be brought on a final appeal to the Secretary of Health whose decision shall be absolute and executory.

XI. REPEALING CLAUSE

Previous issuances or any of their provisions which are inconsistent or contrary to the provisions of this issuance 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.

(SGD.) FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health

ANNEX A

Assessment Tool for Licensing a COVID-19 Testing Laboratory

ANNEX B1

COVID-19 Testing Laboratory

ANNEX B2

COVID-19 Testing Laboratory

ANNEX C

Annex 2 Risk Assessment Template

ANNEX D1

Reference Plan

ANNEX D2

Checklist for Review of Floor Plans COVID-19 Testing Laboratory Using RT-PCR

ANNEX E

Application for License to Operate COVID-19 Testing Laboratory