Lecture 5 - RA 4688

REPUBLIC ACT NO. 4688

The law regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the DOH through the Health Facilities and Services Regulatory Bureau (HSFRB).

To ensure access to quality and affordable health products, devices facilities, and services especially those commonly used by the poor.

Main objective of regulating clinical laboratories in the Philippines:

ASMINISTRATIVE ORDER NO. 2012 – 0021 o

o National Framework of the National Health Laboratory Network

o Approved on October 12, 2012

DEPARTMENT MEMO NO. 2009 – 0086

o "Implementation of External Quality Assessment Program as a Regulatory Requirement for Licensing of Clinical Laboratories"

o Approved on Feb 3, 2009

DEPARTMENT MEMO NO. 2009 – 5148

Amended to Department Order No. 393 - E series of 2000, designating the Philippine Heart Center as the National Reference Laboratory in anatomic pathology for cardiac diseases.

ADMINISTRATIVE ORDER NO. 2007 – 0027 – A

o Amendment to Section III of Administrative Order No. 2007-0027 to exempt the National Tuberculosis Reference Laboratory from securing a License to Operate as a clinical laboratory

o Approved on August 28, 2008

Administrative Order No. 2007 – 0027

o "Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories"

o The current implementing rule of R.A. No. 4688

o Approved on August 22, 2007

Administrative Order No. 2007 – 0011

o Repeal of Administrative Order 118-B series of 1992, entitled "Rules and Regulations Governing the Accreditation of Clinical Laboratories for the Training of Medical Technology Interns"

o Approved on April 4, 2007

Administrative Order No. 59, Series of 2001

o Rules and regulations governing the establishment, operation, and maintenance of clinical laboratories in the Philippines

o Approved on November 19, 2001

Administrative Order No. 393, - E series 2000

o “Designation of National Reference Laboratories and Transfer of corresponding Equipment, Instruments, Supplies and Specimens, Records from the Bureau of Research and Laboratories to the Designated national Reference Laboratories"

Administrative Order No. 118, - B series 1992

o "Rules and regulations Governing the Accreditation of Clinical Laboratory for Training of Medical Technology Interns"

o Approved on March 16, 1992

Bureau Order No. 04, series of 1990

o "Technical Standards for the Registration, Operation and Maintenance of Clinical Laboratories in the Philippines"

Administrative Order No. 49, - B series 1988

o "Revised Rules and Regulation Governing the Registration, Operation and Maintenance of Clinical Laboratories in the Philippines"

o Approved on October 24, 1998

▪ Ownership

▪ Function

▪ Institutional Character

▪ Service Capacity

Under Administrative Order No. 2007-0027 of the revised rules and regulations governing the licensing and regulation of clinical laboratories in the Philippines, clinical laboratories can be classified based on:

GOVERNMENT-OWNED LABORATORIES

o Are those which are maintained, partially or wholly, by either the national or local government.

PRIVATE LABORATORIES

o Are established, operated, and maintained by an individual, corporation, or association without any affinity with the government

CLINICAL PATHOLOGY

▪ Clinical Chemistry

▪ Hematology

▪ Immunohematology

▪ Microbiology

▪ Immunology

▪ Clinical Microscopy

▪ Serology

▪ Endocrinology

▪ Molecular Biology

▪ Cytogenetics

▪ Toxicology

▪ Therapeutic Drug Monitoring

ANATOMIC PATHOLOGY

▪ Surgical

▪ Immunology

▪ Histopathologic

▪ Cytologic

▪ Autopsy Procedure

▪ Forensic

▪ Molecular Pathologic Techniques

INSTITUTION-BASED CLINICAL LABORATORY

If a laboratory operates within the premises and as part of an institution such as a hospital, clinic, school, or a medical facility.

FREE-STANDING LABORATORY

If it has no affinity with any other institution.

PRIMARY

offer standard laboratory procedures such as:

▪ Routine Hematology

▪ Urinalysis

▪ Fecalysis

▪ Blood Typing

PRIMARY

Must have a minimum technical working area of at least 10 square meters.

SECONDARY

provide the minimum service capabilities of a primary laboratory with added services such as:

▪ Routine Chemistry Analysis

▪ Cross-matching

▪ Gram Staining

▪ KOH preparations

SECONDARY

Must have a minimum technical working area of at least 20 square meters.

TERTIARY

provide the service capabilities of a secondary laboratory in addition to the following services:

▪ Special Chemistry Procedures

▪ Special Hematology

❖ Coagulation Procedures

▪ Immunology

▪ Culture and Sensitivity Procedures

TERTIARY

Must have a minimum technical working area of at least 60 square meters.

LIMITED SERVICE

Only for Institution-Based

LIMITED SERVICE

They provide laboratory tests required for a particular service in an institution but they are not limited to Dialysis Center and Social Hygiene Clinic.

RG-1

Agents that are NOT associated with diseases in healthy adult humans.

RG-2

Agents that are associated with human diseases that are RARELY serious

RG-2

Preventive or therapeutic interventions are OFTEN available.

RG-3

Agents that are associated with serious or lethal human diseases

RG-3

Preventive or therapeutic interventions MAY be available.

RG-4

Agents that are likely to cause SERIOUS or LETHAL human diseases

RG-4

Preventive or therapeutic interventions are NOT USUALLY available.

RG-1

Bacillus subtilis

RG-1

Escherichia coli K12

RG-1

adeno associated virus (AAV)

RG-2

Staphylococcus aureus

RG-2

Salmonella sp

RG-2

Herpes simplex viruses

RG-2

Adenovirus

RG-3

Mycobacterium tuberculosis

RG-3

Bacillus anthracis

RG-3

HIV

RG-4

Ebola virus

RG-4

Marburg virus

RG-4

Lassa virus

RG-4

COVID-19

BIOSAFETY LEVEL 1 LABORATORIES

o Laboratories that fall under this classification include those that handle organisms that are considered by the WHO as Risk Group 1, i.e., those that are unlikely to cause human diseases.

BIOSAFETY LEVEL 1 LABORATORIES

Personnel who work in a Biosafety Level 1 laboratory are expected to wear the standard personal protective equipment (PPE) such as masks, gloves, and laboratory gowns.

BIOSAFETY LEVEL 1 LABORATORIES

Special containment systems are NOT REQUIRED for this type of laboratory.

BIOSAFETY LEVEL 2 LABORATORIES

These laboratories handle a broad spectrum of moderate-risk agents or Risk Group 2 organisms associated with human diseases with different degrees of severity.

BIOSAFETY LEVEL 2 LABORATORIES

The personnel working in this type of laboratory normally process human-derived specimens such as blood, body fluids, tissues, and, to some extent, human cell lines in which the organism causing the disease is unknown.

BIOSAFETY LEVEL 2 LABORATORIES

Aside from wearing PPE, the personnel have secondary barriers such as a sink, waste decontamination facilities (such as an autoclave) to reduce the transmission of biohazard waste, and a biosafety cabinet.

BIOSAFETY LEVEL 3 LABORATORIES

handle Risk Group 3 organisms that are considered indigenous or exotic agents with the potential to be transmitted via respiratory routes and that can cause severe or sometimes fatal infection.

BIOSAFETY LEVEL 3 LABORATORIES

ALL procedures in processing samples should be done in a biosafety cabinet with a gas-tight aerosol generation chamber.

BIOSAFETY LEVEL 4 LABORATORIES

handle extremely dangerous and exotic agents that can be transmitted through the air, have NO available vaccine or therapeutic cure, and are under Risk Group 4 classification.

BIOSAFETY LEVEL 4 LABORATORIES

required to wear full-body, air-supplied positive pressure suits.

BIOSAFETY LEVEL 4 LABORATORIES

o Moreover, this kind of laboratory is provided with a specialized ventilation and waste management system.

o Most of the time, such a facility operates in a separate building.

LICENSE TO OPERATE (LTO)

A document issued by the DOH to an individual, agency, partnership, or corporation that operates a clinical laboratory upon compliance with the requirements set forth by the law.

GOVERNMENT HOSPITAL LABORATORIES

performing routine or minimum laboratory operations shall be exempted from the provisions of these sections.

LICENSE TO OPERATE (LTO)

valid for 1 YEAR and it must be renewed annually

PHYSICIAN’S OFFICE LABORATORY (POL)

An individual doctor's office/clinic wherein laboratory examinations are performed.

PHYSICIAN’S OFFICE LABORATORY (POL)

Examinations done in a POL are permitted as long as they are used for monitoring patients.

MOBILE CLINICAL LABORATORY

A specialized facility that moves from one testing site to another or has a temporary testing location.

MOBILE CLINICAL LABORATORY

They are licensed as part of the main clinical laboratory and they are only permitted to COLLECT SPECIMENS ONLY.

MOBILE CLINICAL LABORATORY

Only allowed to operate within a 100-kilometer radius from its main laboratory.

POINT OF CARE TESTING (POCT)

a diagnostic test at or near the site of patient care rather than in the clinical laboratory.

PATHOLOGIST

WHO HEADS AND MANAGES A CLINICAL LABORATORY?

PHYSICIAN WITH COMPLETE TRAINING IN CLINICAL LABORATORY MEDICINE AND LABORATORY MANAGEMENT MAY MANAGE

In areas where there is no pathologist,

MAY ONLY MANAGE 1 PRIMARY CLINICAL LABORATORY

A licensed physician

GUIDELINES OF ESTABLISHING THE NUMBER OF LABORATORY PROFESSIONALS

working hours vary from A minimum of 8 hours to a maximum of 12 hours.

SINGLE LABORATORY TEST

estimated to be processed within 10 minutes (10 minutes per test)

MANUAL TESTING

50 tests/RMT/8 hours

MANUAL TESTING

75 tests/RMT/12 hours

AUTOMATED TESTING

100 tests/RMT/8 hours

AUTOMATED TESTING

150 tests/RMT/12 hours

HFSRB/ Center for Health Development (CHD)

WHERE IS THE APPLICATION FOR LTO FILED?

HFSRB/ Center for Health Development (CHD)

WHO INSPECTS AND MONITORS CLINICAL LABORATORIES?

NATIONAL REFERENCE LABORATORY (NRL)

A laboratory in a government hospital that has been designated by the DOH to provide special functions and services for specific disease areas:

▪ Confirmatory testing (If there are positive tests)

▪ Surveillance resolution of conflicting results between or among the laboratories

▪ Training

▪ Research implementation of External Quality Assessment Survey (EQAS)

▪ Evaluation of diagnostic kits and reagents.

PHILIPPINE NATIONAL HEART CENTER (PNHC)

o Anatomic pathology for cardiac diseases

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI)

o Hematology

o Coagulation tests

o Immunohematology

o Immunopathology

o Anatomic pathology for renal diseases

o Automated urinalysis

LUNG CENTER OF THE PHILIPPINES (LCP)

o Clinical chemistry

o Anatomic pathology for pulmonary diseases

STD/AIDS COOPERATIVE CENTRAL LABORATORY (SACCL) / SAN LAZARO HOSPITAL (SLH)

o Screening

o Confirmatory tests for HIV, syphilis, hepatitis B and hepatitis C

RESEARCH INSTITUTE FOR TROPICAL MEDICINE (RITM)

o Dengue

o Influenza

o Tuberculosis and other mycobacteria

o Malaria and other parasites

o Bacterial enteric diseases

o Measles and other exanthems

o Enterovirus

o Antimicrobial resistance

o Emerging and re-emerging infections

o Confirmatory testing for blood donors and blood units

o Rabies

o Japanese encephalitis and other pathogens that cause meningitis and meningoencephalitis

EAST AVENUE MEDICAL CENTER (EAMC)

o Screening and confirmatory drug tests

o Water testing portability

o Analytical toxicology

o Methemoglobin

o Hemoglobin and Sulfhemoglobin

EXTERNAL QUALITY PROGRAM (EQAP)

It is mandated that all clinical laboratories must participate

MEDICAL TECHNOLOGIST & PATHOLOGIST

WHO ARE THE PERSONS AUTHORIZED TO SIGN AN OFFICIAL LABORATORY REPORT?

OUTSOURCING

only allowed when the laboratory test required is not part of the service capability of the referring clinical laboratory, and it is part of a contingency plan in case of an equipment breakdown.

SECRETARY OF HEALTH

WHO IS TASKED TO ENFORCE THE PROVISIONS OF THE CLINICAL LABORATORY LAW AND ITS IMPLEMENTING RULES?

➢ IMPRISONMENT for not less than 1 month but not more than 1 year, or;

➢ FINE of not less than ₱1,000 or more than ₱5,000, or;

➢ Both such FINE AND IMPRISONMENT, at the discretion of the court

Any person, firm, or corporation who violates any provisions of R.A. No. 4688 or the rules and regulations issued thereunder by the Secretary of Health shall be punished with:

HFSRB/ Center for Health Development (CHD)

WHO WILL INVESTIGATE THE COMPLAINT LODGED AGAINST A CLINICAL LABORATORY?