RA 4688 and RA 7719 Flashcards by Merphy Papin

**In order to maintain quality in our laboratory services, there
should be involvement by the government

Regulation by the government
Clinical laboratories should follow standards in their
operation and in providing laboratory services

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**Apart from international regulations, the government itself has
its own laws in place

Minimum requirements only

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Whether in hospitals or not (Red Cross)

**Blood banks should also follow standards

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Clinical Laboratory Act of 1966

**RA 4688

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Will specify provisions of the law
o Specific meaning
o Scope

**Implementing Rules and Regulations (IRR)

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“An Act Regulating the Operation and Maintenance of
Clinical Laboratories and Requiring the Registration of
the Same with the Department of Health, Providing
Penalty for the Violation Thereof, and for Other
Purposes”  complete title

Clinical Laboratory Act of 1966

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Clinical Laboratory Act of 1966 Approved on:

June 18, 1966

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DOH: Implementing Agency of health-related
laws
 Issues IRR  guidelines

UPDATED by several IRR

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There is a “…necessity to review the current AO and to
revise and update the minimum standards and
technical requirements for licensing clinical
laboratories in the Philippines is aligned with the main
objective of Republic Act No. 11223 or the Universal
Health Care Act which is to guarantee access to quality
and affordable health products, devices, facilities and
services

AO #37 series 2021
- Approved on: June 11, 2021

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Shall serve as the new guidelines in licensing diagnostic clinical
laboratories in the Philippines

AO 37 ser. 2021

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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

o Facility that is involved in the
 (a) pre-analytical
 (b) analytical
 (c) post-analytical procedures

Clinical Laboratory (CL)

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SCL

satellite clinical laboratory

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mobile clinical laboratory

MCL

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Are medtechs allowed to supervise CL?

No, that is not the scope of our profession

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Are medtechs allowed to supervise CL?

No, that is not the scope of our profession

**Kapag walang pathologist, the lab may be supervised a nonpathologist physician (dating AOs)

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 Renew license here
 With inspection of DOH personnel

Center for Health Development

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o Must be registered in HSFRB
o Registration permit  no inspection
o Shall be placed in an area that can readily be
seen by the public at all times

Research/academic labs

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 Apply for new license if:
 New owner
 Transfer of location

Non-transferable

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Changes: name, ownership, headship, inform DOH within

15 days

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 License Validity
- DOH-LTO:
 Whether hospital-based or freestanding

valid for 1 year

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 DOH has a scheduling
scheme in renewing license
of CL

After 1 year, should renew

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90 days before expiration
date
(busy starting October)

Dec. 31st of the year

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Required to register with the DOHHFSRB every 3 years

COR of CL operated for research and training

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o A program where participating CL are given
unknown samples for analysis (by reference
labs)

o Samples should be treated as ordinary human
specimens for the usual processing and
examination

o The quality of performance of the CL shall be
assessed through the closeness of its results to
the pre-determined value (reference value)
generated by the participating CL through peer
group analysis

External Quality Assessment Program

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o Best practice to maintain quality of lab and check skills of MTs o Need maipasa per section ng lab

National External Quality Assessment Scheme

- Operating CL without LTO-CL o Issuing fraudulent lab test results knowingly, willfully, or through gross negligence **Penalty: up to 50,000 pesos **Revocation or suspension of license

Violation

- All existing licensed CL - For new CL

Transitory Provision

shall be given 3 years to comply with the physical plant requirements from the date of effectivity of this Order

All existing licensed CL

shall be given _____ to fully offer the additional services for each category with corresponding personnel and equipment from the date of effectivity of this Order

2 years

shall be given_____ to comply with the physical plant requirements from the date of effectivity of this Order

3 years

this Order shall be immediately applicable  Habang pinaplano, i-adapt na nila yung nasa new IRR

For new CL

 Do not qualify in the scope of the law  Research  Academic  Genetics for research  Immunohematology/Blood bank  Has separate regulation  Don’t need to follow this IRR

Special CL

same as AO 27 series 2007 o Private o Government-owned

By ownership

same as AO 27 series 2007 o Free-standing o Institution-based (hospital-based)

By institutional character

o Clinical pathology o Anatomic pathology o + Molecular pathology

By functions

Deals with the analysis of certain genes, proteins and other molecules in samples from organs, tissues or bodily fluids in order to diagnose disease and/or to guide the prevention and treatment of disease based on the principles, techniques and tools of molecular biology as they are applied to diagnostic medicine in the lab

+ Molecular pathology

o Primary o Secondary o Tertiary o Limited-service

By service capabilities

- Primary - Secondary - Tertiary - Limited

Lab Services

Kung ano nakalista

Primary

o Primary + yung nakalista sa kanya

Secondary

o Primary + secondary + nakalista sa kanya

Tertiary

o Do not follow minimum services of primary, secondary, and tertiary CL o Designed to cater needs of specific needs o Ex. Hemodialysis, Cancer center, Malarial center

Limited

Minimum number of Lab personnel - Primary:

o Private: at least 8 RMTs o Government: at least 9 RMTs

Minimum number of Lab personnel Secondary

at least 12 RMTs o Regardless if private or government

Minimum number of Lab personnel Tertiary

o At least 12 RMTs without histopathology o At least 13 RMTs for hospital-based

at least 1 RMT per section

CL for AP

at least 3 RMTs (depend on services offered)

CL for MP

- Stationed in San Lazaro Hospital - Provides training for HIV testing

**SACCL – STD AIDS COOPERATIVE CENTRAL LABORATORY

- Training provided by the National Tuberculosis Research Laboratory

**DSSM – DIRECT SPUTUM SMEAR MICROSCOPY

RITM

RESEARCH INSTITUTE FOR TROPICAL MEDICINE

- Provides service for genetics, immuno/hematopathology and infectious diseases - COVID-19 testing laboratories shall be covered by another AO

Clinical Laboratory for Molecular Pathology only

Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines *Before molecular testing, antibody testing was only done

AO #14 series 2020

AO #14 series 2020 Approved on:

April 7, 2020

6 months to produce antibodies might become false positive AO #14 series 2020

Babies

Health facility where COVID-19 testing is done on specimens from the human body to obtain info about the health status of a patient for the prevention, diagnosis, and treatment of disease

COVID-19 Testing Laboratory

Whether free-standing or hospital-based

Laboratory should be a DOH-LTO holder

1. Laboratory should be a DOH-LTO holder 2. LTO is issued upon full compliance to standards and requirements of RITM and CHD-RLED 3. DOH-LTO of a hospital-based COVID-19 testing lab should be subsumed in the LTO of the hospital 4. DOH-LTO of non-hospital-based 5. COVID-19 testing lab should have a separate unit with its own designated working area 6. Should follow strict biosafety and biosecurity guidelines

General guidelines AO #14 series 2020

a. Existing LTO  Can put up COVID-19 testing lab as long as they are approved by DOH b. With COR by DOH or w/o DOH  Shall be issued as COVID-19 testing lab with limited-service capability

DOH-LTO of non-hospital-based

Can put up COVID-19 testing lab as long as they are approved by DOH

Existing LTO

Shall be issued as COVID-19 testing lab with limited-service capability

With COR by DOH or w/o DOH

o Separate performance of procedures to avoid cross-contamination o Extraction (most dirty)  reagent preparation  PCR  If only 1 person will do that, process is prone to contamination

Situation: PCR

clinical pathologist with training in Molecular Laboratory Diagnostics

Head

should have appropriate trainings prescribed by RITM  3 RMTs or 2 RMTs and 1 molecular biologist

Staff

Cleans the lab to avoid contamination

1 full-time lab aide: per 8-hr shift

o Receiving area o Encodes patient info

1 full-time receptionist: per 8-hr shift

Encodes result

1 full-time encoder: per 8-hr shift

- Proficient in molecular biology techniques, biosafety, and biosecurity - Should undergo fit testing - Shall have annual medical examination - Shall have continued updated training in biosafety, biosecurity, new techniques and technologies

Minimum requirement for staff

Minimum requirement for staff Should undergo fit testing

o Respirator with at least 95% efficiency ( N95 mask) o Person will breathe through their mouth while wearing respirator

Shall have annual medical examination

With influenza vaccination

Must pass EQAS o Swab samples are given to the lab by RITM o Lab should test samples and report results to RITM k Report value of gene detected in PCR

Quality improvement activities

- Logbook - Laboratory Information System - Processes and concerns must be well-documented

Information management

- HFSRB - CHD-RLEDs

Licensing Requirement

o Based in Level 2 and 3 hospitals and specialty hospitals

HFSRB

Non-hospital-based labs and Level 1 hospitals

CHD-RLEDs

LTO is valid for

1 year only

The enactment of RA 4688 otherwise known as “Clinical Laboratory Act of 1966” took place on A. June 16, 1966 B. July 18, 1966 C. June 18, 1966 D. February 13, 1966

C. June 18, 1966

Regular inspection of clinical laboratories is done every ________?

o Every 2 years

Are MT allowed to supervise CL?

No  MT can own and work in lab but not manage  Pathologists manage the lab

Crystal Lab is a tertiary, privately owned laboratory whose main lab is situated in Makati. It has branch labs in:  E. Rodriguez Ave., Quezon City o Tertiary category  Binondo, Manila o Tertiary Category  Taft Ave., Pasay City o Secondary Category **Which of these would require a license to operate? A. Only the main lab in Makati B. Main lab + the 2 tertiary branch lab C. Main lab + secondary CL D. Main labs + all the branch labs

D. Main labs + all the branch labs

Validity of license to operate laboratories?

o 1 year only

A clinical laboratory installed a dialysis center performing lab tests limited to creatinine and BUN determinations is classified as:

Limited-service CL

Most recent implementing rules and regulations for RA 4688

AO #37 series 2021

All clinical pathology reports must be kept on file in the laboratory for how long?

At least 1 year

Clinical pathology reports: kept on file for

at least 1 year

Anatomic pathology reports:

permanently kept on file

Where should a clinical lab secure/renew its license to operate? A. DOH-BHFS B. DOH-CHD C. Either D. Neither

DOH-CHD

How long is the license of clinical labs performing diagnostic tests valid? A. 1 year B. 2 years C. 3 years D. Lifetime

A. 1 year

Mandatory personnel of clinical laboratory: A. Medical Technologist B. Laboratory technician C. Pathologist D. A and C

A. Medical Technologist C. Pathologist

The application for renewal of license to operate clinical laboratories begin _____ days before expiration day A. 20 B. 60 C. 30 D. 90

RA 4688 and RA 7719 Flashcards

(89 cards)