Module 6: Clinical Laboratory for Molecular Pathology and Licensure of COVID-19 Testing Laboratories

Flashcards covering key standards, guidelines, personnel requirements, processes, and comparisons for DOH Administrative Orders 2023-0018 and 2023-0004.

Main objective of DOH Administrative Order No. 2023-0018?

To provide guidelines in the regulation of diagnostic Clinical Laboratories for Molecular Pathology in the Philippines, whether private or government-owned, to ensure accountability in generating accurate and precise results while safeguarding public safety.

Biorisk Assessment

The process to identify acceptable and unacceptable risks and their potential consequences.

What are the staffing, qualification, and training requirements for personnel in a Clinical Laboratory for Molecular Pathology under DOH A.O. 2023-0018?

Head of Laboratory: Board-certified Pathologist (CP, AP, or AP/CP) trained in Molecular Diagnostics and Biorisk Management. Analysts: 3 per shift trained in Molecular Diagnostic techniques, with at least 1 per shift trained in Biorisk Management. Support Staff: At least vocational graduates with in-house biosafety training (at least 1 per shift).

What is the process flow for the initial licensing of a Clinical Laboratory for Molecular Pathology?

Apply for DOH-PTC at HFSRB -> Apply for DOH-LTO -> Evaluators assess technical completeness -> Issuance of Order of Payment -> HFSRB conducts inspection -> LTO recommendation (with a 30-day stop-clock if non-compliant) -> Approval and signing of DOH-LTO -> Recording and releasing of approved DOH-LTO.

What is the validity period of a DOH License to Operate (DOH-LTO) for a Clinical Laboratory for Molecular Pathology under DOH A.O. 2023-0018?

The DOH-LTO is valid until December 31 of the current calendar year.

What is the appeal process and timeline for a Clinical Laboratory for Molecular Pathology contesting a decision by the DOH-HFSRB?

File a notice of appeal to the Head of the Health Facility and Patient Support Team (HFPST) within ten (10) days after receipt of the notice of decision. A final appeal may be brought to the Secretary of Health, whose decision is final and executory.

What is recommended by the WHO as the reference standard for detecting SARS-CoV-2 genetic material?

Nucleic Acid Amplification Tests (NAAT) such as Real Time Reverse Transcriptase - Polymerase Chain Reaction (rRT-PCR).

Who issues and signs the Certificate of Proficiency required before a COVID-19 Testing Laboratory can operate?

A certification from RITM signed by the Office of the Undersecretary of Field Implementation and Coordination Team (FICT) NCR and Luzon (COVID-19 Laboratory Operations Team Lead).

How do freestanding collection sites differ from satellite collection sites for COVID-19 testing?

Freestanding collection sites are not owned by any DOH-licensed COVID-19 TL and require a valid MOA with a DOH-licensed COVID-19 TL, whereas satellite collection sites are remote collection sites owned directly by the DOH-licensed COVID-19 TL.

Is outsourcing of examinations allowed for NAAT-based COVID-19 Testing Laboratories under DOH A.O. 2023-0004?

No, NAAT-based COVID-19 Testing Laboratories are strictly prohibited from outsourcing examinations.

Within how many days must a COVID-19 Testing Laboratory notify DOH-HFSRB or CHD-RLED in writing of any substantial changes in physical plant, equipment, or personnel?

Within fifteen (15) days. Failure to do so may be a basis for suspension or revocation of the DOH-LTO.

What are the specific human resource requirements per 8-hour shift for a non-cartridge-based rRT-PCR COVID-19 Testing Laboratory?

Three (3) analysts (either 3 RMTs, or 2 RMTs + 1 allied health professional), one (1) laboratory aide, one (1) encoder per 200 samples, one (1) receptionist, and one (1) analyst as a reliever.

What are the human resource requirements per 8-hour shift for a cartridge-based rRT-PCR COVID-19 Testing Laboratory?

One (1) RMT per two (2) machines, one (1) laboratory aide per four (4) machines, one (1) encoder per four (4) machines, and one (1) analyst as a reliever.

What are the minimum required air changes per hour (ACH) for the processing rooms in a COVID-19 Testing Laboratory?

12 ACH for the sample receiving room and sample preparation room, and 6 ACH for the PCR room.

What is the duration of validity for a DOH-LTO issued to a COVID-19 Testing Laboratory under DOH A.O. 2023-0004?

The DOH-LTO of a COVID-19 Testing Laboratory is valid for one (1) year.

What is the standard chemical procedure specified for decontaminating work surfaces in a COVID-19 Testing Laboratory?

Decontamination of work surfaces and items using 10% bleach or RNAse Away, followed by 70% ethanol.

AO No. 2016-0042

Guidelines in the Application for the DOH-PTC

Polymerase Chain Reaction and Fluorescent In-Situ Hybridization

What are the most commonly available tests in the country, allowing gene detection, even if they may be present in minute quantities?

Bangsamoro Autonomous Region in Muslim Mindanao (BARMM) & Bangsamoro Organic Act (Republic Act No. 11054)

In case of ________, the adoption of this Order shall be in accordance with the _________ and subsequent laws and issuances.

Clinical Laboratory (CL)

refers to a facility that is involved in the (a) pre-analytical, (b) analytical, (c) and post-analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis and treatment of diseases.

Anatomic pathology, clinical microscopy, clinical chemistry, endocrinology, hematology, immunology and serology, microbiology, toxicology, and molecular and nuclear diagnostics

What are the tests offered in CL?

Section VI. E of AO No. 2012-0012: “Rules and Regulations Governing the New Classification of Hospitals and Other Health Facilities in the Philippines” and the QMS guidelines of the HFSRB/CHD-RLED.

The process for inspection shall follow….

Section VI. F of AO No. 2012-0012: “Rules and Regulations Governing the New Classification of Hospitals and Other Health Facilities in the Philippines” and the QMS guidelines of HFSRB/CHD-RLED.

The process for monitoring shall follow…

Real Time Reverse Transcriptase-Polymerase Chain Reaction (rRT-PCR)

Currently, the reference standard for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, are Nucleic Acid Amplification Tests (NAAT) such as ____

Applicant

refers to any natural or juridical person, government instrumentalities/agencies, partnership, corporation, or agency seeking a DOH License- to operate and maintain a NAAT COVID-19 TL

Certificate of Proficiency

Office of the Undersecretary of Field Implementation and Cooperation Team NCR and Luzon

____ refers to a Certification from RITM signed by the ______ (COVID-19 Laboratory Operations Team Lead) that the COVID-19 TL has

completed and passed the proficiency testing. It is required prior to the operation of the COVID-19 TL.

Nucleic Acid Amplification Test (NAAT)

It refers to a molecular test that amplifies or makes multiple copies of detected target genetic material from a given sample.

PCR-based

refers to a technique of amplifying target sequence from DNA template in an exponential manner generally with the aid of target-specific primers, dNTPs, Mg ions, a Taq polymerase enzyme and a PCR thermal cycler; such as rRT-PCR and Multiplex PCR

Isothermal Amplification Methods (non-PCR-based)

it refers to amplification of a specific nucleic acid fragment at constant temperature with the use of a heat block instead of a thermal cycler; such as loop-mediated isothermal amplification (LAMP) and transcription-mediated amplification (TMA).

Remote Collection

It refers to all sample collection activities for SARS-CoV-2 detection using NAAT, done outside and not within the DOH-licensed COVID-19 TL.

Freestanding Collection Sites

It refers to collection sites not owned by any DOH-licensed COVID-19 TL with the sole purpose of collecting specimens/samples for COVID-19 testing. A valid Memorandum/Memoranda of Agreement (MOA) with DOH-licensed COVID-19 TL shall be required for these freestanding collection sites.

Satellite Collection Sites

refers to remote collection site owned by the DOH-licensed COVID-19 TL but located outside the premises/compound of the DOH-licensed COVID-19 TL.

AO 2020-0013 issued Abril 9, 2020

“Revised Administrative Order No. 2020-0012 “Guidelines for the Inclusion of the Coronavirus Disease 2019 (COVID-19) in the List of Notifiable Diseases fornMandatory Reporting to the Department of Health” dated March 17, 2020,” and its amendments.

Department Memorandum (DM)No. 2020-0542 issued on December 17, 2020

“Interim Guidelines on the Compliance of COVID-19 Testing Laboratories

to Data Submission and Quality Standards.”

AO. No. 2021-0037

New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

Annex A

Licensing Standards for NAAT-based specific for rRT-PCR COVID- 19 TL

Annex B

Assessment Tool for Licensing a COVID-19 TL

Annex C

Guideline in Mandatory Notification of Remote Collection Activity of

NAAT-based COVID-19 TL

Annex D

Planning and Design Guidelines for a COVID-19 TL

Annex E

Checklist for Review of Floor Plans for COVID-19 TL using (E1) Non-

Cartridge-Based and (E2) Cartridge-Based

Annex G

Department Circular No. 2021-0275 titled “Advisory on the Regulation

on Innovations in the RT-PCR Plate Based Diagnostic Platform for COVID-19