DOH AO NO. 2021-0037

New Rules & Regulations governing the Regulations of Clinical Laboratories in the Philippines

New Rules & Regulations governing the Regulations of Clinical Laboratories in the Philippines

What is the title of DOH AO NO. 2021-0037

DOH AO NO. 2021-0037

This refers to the New Rules & Regulations governing the Regulations of Clinical Laboratories in the Philippines

13 sections

How many sections does DOH AO NO. 2021-0037 have?

June 11, 2021

When did DOH AO NO. 2021-0037 take effect?

Francisco Duque III (DOH Secretary) and President Rodrigo Duterte

Who signed the DOH AO NO. 2021-0037?

Clinical Laboratory Law of 1966

What is RA 4688?

RA 4688

What is the RA of Clinical Laboratory Law of 1966?

AO 59 s2001

This refers to the Rules & Regulations Governing the Establishment, Operation and Maintenance of Clinical Labs in the PH

AO 2007-0027

This refers to the revised Rules & Regulations Governing the Licensure & Regulation of Clinical Labs in the PH

Universal Health Care Act

What is RA 11223?

RA 11223

This act guarantee the access to quality & affordable health products, devices, facilities, and services

FALSE

TRUE or FALSE The scope of DOH AO NO. 2021-0037 includes COVID-19 testing laboratories.

DOH AO NO. 2020-0014

What administrative order does the COIVD-19 testing labs fall under?

Applicant

This refers to any natural juridical person, government instrumentalities/agencies, partnership, corporation, or agency seeking a license to operate and maintain a clinical laboratory

Assessment Tool

This refers to the checklist which prescribes the minimum standards and requirements for licensure of a clinical lab

Clinical Laboratory

This 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 to obtain information about the health status of a patient

DOH - License to Operate

This is a formal authorization issued by the DOH to those who are seeking to perform laboratory tests in compliance with the requirements

DOH - Permit to Construct

This is a permit issued by DOH through HFSRB or Center for Health Development-Regulation, Licensing and Enforcement Division (CHD-RLED)

DOH - Permit to Construct

This document is required for hospitals and other health facilities with substantial alteration, expansion, renovation, increase in the number of beds, transfer of site, or for additional services

(EQAP) External Quality Assessment Program

What program gives participating CLs unknown samples for analysis?

Initial Application

This refer to the applications by newly constructed health facilities, or those with changes in the circumstances of the facility

Mobile Clinical Laboratory

This refers to a lab testing unit that performs limited CL diagnostic procedures that moves from one testing site to another

Mobile Clinical Laboratory

This refers to a laboratory that is in a 100km radius from the Clinical Lab

(NEQAS) National External Quality Assessment Scheme

This assesses the quality of performance and accuracy of the results of laboratories

(NRL) National Reference Laboratory

NEQAS is conducted by what organization?

(NRL) National Reference Laboratory

This is the highest level of laboratory in the country performing highly complex procedures

(NRL) National Reference Laboratory

This is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines

(POL) Physician's Office Laboratory

This refers to a doctor's office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor's patients only

(POCT) Point of Care Testing

This refers to the diagnostic testing done at or near the site of patient care rather than in the CL

(SCL) Satellite Clinical Laboratory

This refers to the extension of the main CL that has the same service capability as the main laboratory

Referral Tests

These refer to CL tests that are either sent-out or outsourced to other DOH licensed CL with the same or higher service capability

• Letter of Application to the Director of Health Facilities & Services Regulatory Bureau

• Four (4) sets of Site Development Plans & Floor plans approved by an Architect or Engineer

• DTI Sec registration (private)

What are the requirements for the application of DOH-PTC?

Four (4)

How many site development & floor plans does the DOH-PTC require?

AO No. 2016-0042

What administrative order has the guidelines in the application for DOH-PTC?

• HFSRB (Health Facilities And Services Regulatory Bureau)

• or Center of Health Development Regulatory Licensing & Enforcement Division (CHD-RLED)

DOH-LTO is issued by?

One (1) year

DOH-LTO is valid for how many years?

One (1) year

DOH-PT is valid for how many years?

Ninety (90) days

How many days before to the expiration date of your LTO should you submit your renewal application?

January to March

What is the schedule for license renewal application in the NCR region?

February to April

What is the schedule for license renewal application in the 1, 2, 3, CAR regions?

March to May

What is the schedule for license renewal application in the 4, 5, 6 regions?

April to June

What is the schedule for license renewal application in the 7, 8, 9 regions?

May to July

What is the schedule for license renewal application in the 10, 11, 12, CARAGA, & ARMM regions?

P1,000 + Renewal Fee

How much is the penalty when an applicant failed to renew his/her LTO for two months?

P100 each month

How much is the late fee for each month that a license is not renewed on time?

(HFSRB & CHD-RLED)

• Health Facilities & Services Regulatory Bureau

• Center for Health Development Regulation, Licensing and Enforcement Division

Application & Renewal of DOH-LTO shall be approved by _________ & __________?

Four (4)

How many classifications of clinical lab are there?

1. by Ownership

2. by Institutional Characteristics

3. by Function

4. by Service Capability

Enumerate the classifications of Clinical Labs

1. Government-owned

2. Privately-owned

What laboratories fall under the classification of Ownership?

1. Clinical Pathology

2. Anatomic Pathology

3. Molecular Pathology (new)

What laboratories fall under the classification of Function?

1. Institution-based

2. Non-institution based

What laboratories fall under the classification of Institutional Characteristics?

1. Primary Category

2. Secondary Category

3. Tertiary Category

4. National Reference Laboratory

What laboratories fall under the classification of Service Capability?

Government-owned laboratory

This laboratory is operated and maintained, partially or wholly, by the national government, a local government unit

Privately-owned laboratory

This laboratory is established & operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization

Institution-based lab

This laboratory is located in the premises & operates as part of a DOH licensed health facility

Non institution-based

This lab operates independently and is not attached to any DOH licensed health facility

Clinical Pathology

This lab deals with the chemical & cellular analyses of blood and other body fluids, identification & examination of microbes and parasites

Anatomic Pathology

This lab provides processing & examination of surgical specimens (microscopic structure of tissues, surgical pathology, cytopathology, immunohistochemical techniques, autopsies, and forensic pathology

Molecular Pathology

This lab deals with the analysis of certain genes, proteins, and other molecules in samples for organs, tissues or bodily fluids in order to diagnose disease

Primary lab

This lab provides minimum service capabilities

Secondary lab

This lab provides the minimum service capabilities of a primary category with additional services

Tertiary lab

This lab provides the minimum service capabilities of a secondary category with additional services

Specialized tests

This lab provides one or two specialized tests that are not classified under anatomic or molecular pathology

Secondary & Tertiary lab

What lab offer these kinds of services?

• Serum

• ALT

• AST

• Coagulation studies

Secondary & Tertiary lab

What lab offer these kinds of services?

• Gram stain

• KOH

• Pap smear

Tertiary lab

This lab offers any machine based serological & immunological testing such as:

• Tumor markers

• Thyroid function tests

• Hepatitis profile

Primary lab

This lab does not offer Anatomic pathology tests

Specialized tests

These tests can be performed by a clinical laboratory as long as it is indicated in the license to operate

National Reference Laboratory

This laboratory is where other labs send specimens for confirmation testing.

a. Confirmatory Testing b. Surveillance c. Resolution of Conflicts d. Training & Research e. Evaluation of kits & reagents f. External quality assessment program

Functions & Services of NRLs

Research Institute for Tropical Medicine (RITM)

What is the reference laboratory for dengue, influenza, tuberculosis, mycobacteria, malaria, bacterial enteric diseases, measles, mycology, enteroviruses, antimicrobial resistance, and emerging diseases?

Research Institute for Tropical Medicine (RITM)

Reference lab for confirmatory testing of SARS-CoV-2

Research Institute for Tropical Medicine (RITM)

Reference lab for measles

Research Institute for Tropical Medicine (RITM)

Reference lab for malaria

Research Institute for Tropical Medicine (RITM)

Reference lab for viral exanthems

Research Institute for Tropical Medicine (RITM)

Reference lab for influenza

Research Institute for Tropical Medicine (RITM)

Reference lab for tuberculosis

STD-AID Cooperative Central Lab San Lazaro Hospital

Reference lab for HIV/AIDS, hepatitis, syphilis, and STIs

STD-AID Cooperative Central Lab San Lazaro Hospital

Reference lab for HIV/AIDS

STD-AID Cooperative Central Lab San Lazaro Hospital

Reference lab for syphilis

STD-AID Cooperative Central Lab San Lazaro Hospital

Reference lab for hepatitis

East Avenue Medical Center

Reference lab for Environmental & Occupational Health

East Avenue Medical Center

Reference lab for Toxicology & Micronutrient Assay

East Avenue Medical Center

Reference lab for drug testing

East Avenue Medical Center

Reference lab for water bacteriology/ drinking water analysis

National Kidney and Transplant Institute

Reference lab for hematology tests

Lung Center of the Philippines

Reference lab for biochemistry

HFSRB/CHD Director

If a person who owns/ runs a Clinical Laboratory break any rules or policies from this law, who would sanction and fine them?

Stern warning

What is the sanction for the 1st offense of a non-institution based CL?

Php 30,000

What/ How much is the sanction for the 2nd offense of a non-institution based CL?

Php 50,000

What/ How much is the sanction for the 2nd offense of a non-institution based CL?

Revocation of DOH-LTO

What is the sanction for the 4th offense of a non-institution based CL?

AO No. 2007-0022 (

According to what administrative order declares the violations under the One-Stop Shop Licensure System for Hospitals?

AO No. 2007-0022

What administrative order governs CLs that are part of hospitals under OSS licensure system?

Cease-and-Desist Order (CDO) & P50,000

Those CLs without DOH-PTC and DOH-LTO would receive an issuance of ___ and a fine that costs ___?

60 day preventive suspension

How many days of investigation is given in case of complaints for the issuance of Cease & Desist Order?

Head of the Health Regulation Team (HRT) - 10 days

Who/Where will you file a notice of appeal if you don’t agree with the HFSRB/CHDRLED's decision?

10 days

Within how many days should you file a notice of appeal in case you do not agree with the HFSRB/ CHDRLED's decision

Secretary of Health

This person will have the last say or final decision whether to accept the appeal or not

FALSE - it should be 1 year after the revocation

TRUE OR FALSE CLs with revoked licenses re-apply after 6 months from the date of LTO revocation?