Unit 3.2: Licensure and Regulation of COVID-19 Laboratories

Question 1

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

Answer 1

Administrative Order No. 2020-0014

Question 2

Amendment to the Administrative Order No. 2020-0014

Answer 2

Administrative Order No. 2020-0014-A

Question 3

Amendment to the Administrative Order No. 2020-0014-A

Answer 3

Administrative Order No. 2020-0014-B

Question 4

Classification of COVID-19 Laboratories (According to Ownership)

Government – created by law; may be under:

at least 5

Answer 4

• National Government
• Department of Health (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)

Question 5

Owned, established and operated with funds through donation, principal, investment or other means by any individual corporation, association or organization; may be:
- Single proprietorship
- Partnership
- Corporation
- Cooperative
- Foundation
- Religious
- Non-government organization

Answer 5

Private

Question 5

Classification of COVID-19 Lab (According to Institutional Character)

• Within the premises or compound of the hospital
• May be part of general clinical laboratory but with designated room distinct from the main laboratory.

Answer 5

Hospital-based

Question 6

Classification of COVID-19 Lab (According to Institutional Character)

Located outside the premises or compound of a hospital and independently functioning on its own

Answer 6

Non-Hospital based

Question 7

What is the minimum number of personnel in a laboratory?

Answer 7

7

Question 8

• ____ Pathologist (with training in Infectious Disease & Molecular Diagnostics)
• ____ Analyst
• ____ Laboratory Aide
• ____ Receptionist
• ____ Encoder

Answer 8

• 1 – Pathologist (with training in Infectious Disease & Molecular Diagnostics)
• 3 – Analyst (3 MTs; or 2 MTs & 1 Allied Health with training)
• 1 – Laboratory Aide
• 1 – Receptionist
• 1 – Encoder

Question 9

Personnel must be trained for:

Answer 9

• Biosafety and Biosecurity
• Molecular Diagnostic Techniques

There must be an annual Medical Exam w/ Influenza Vaccination

Question 10

Equipment and Supplies

Enumerate at least 5 equipments for reagent preparetion

Answer 10

• PCR cabinet/laminar flow
• 4°C refrigerator for reagents
• -20°C freezer for reagents
• Microcentrifuge
• Vortex mixer
• Minifuge
• Cold rack for PCR tube
• Set of four adjustable-volume micropipettes with rack - 100-1000 uL, 20-200 uL, 2-20 uL, and 0.5-10 uL
• Micropipette tips
• Gloves

Question 11

Enumerate at least 5 equipments for specimen preparation

Answer 11

• Biological Safety Cabinet Class II Type A2
• 4°C refrigerator with -20°C for specimens
• 4°C refrigerator with -20°C for nucleic acid extracts
• Microcentrifuge
• Vortex mixer
• Minifuge
• Computer and printer for accessioning
• Cold rack for PCR tube
• Set of four adjustable-volume micropipettes with rack - 100-1000 uL, 20-200 uL, 2-20 uL, and 0.5-10 uL
• Micropipette tips
• Gloves

Question 12

Enumerate at least 5 equipments for aplification/PCR

Answer 12

• Real-time PCR machine
• Conventional PCR machine
• Minifuge
• Computer and printer (associated with the Real-time PCR machine) * -20°C or -40°C freezer for storage of PCR products