4 | RA 4688: Clinical Laboratory Law of 1966

unfinished | licensing not included

Clinical Laboratories

plays a vital role in medical practice.

medical technologist

person who works in a laboratory where he/she is expected to practice his/her laboratory skills with high accuracy and competency (RA 5527)

Clinical Laboratories

provide information and services that can help in detecting, diagnosing, treating and monitoring diseases.

Clinical Laboratories

regulated by the Department of Health

1958

BRL (Bureau of Research and Laboratories) was created

June 18, 1966

R.A. No. 4688 was created

R.A. No. 4688

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

HFSRB

Health Facilities and Services Regulatory Bureau

objective of regulating clinical laboratories

to ensure access to Quality and Affordable Health Products devices facilities and services especially those commonly used by the poor

Physicians

utilize laboratory tests to Aid the diagnosis and management of the patients

accuracy of the laboratory results

important to assure and improve the quality of the patient care

Administrative Order No. 2012 - 0021

National Framework of the National Health Laboratory Network

Administrative Order No. 2012 - 0021

Approved on October 12,2012

Department Memo No. 2009-0086

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

Department Memo No. 2009-0086

Approved on Feb 3, 2009

Department Memo No. 2009-5148

Amended to D.O. 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

Amendment to Administrative Order No. 2007-0027 "Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories"

Administrative Order No. 2007-0027-A

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

Administrative Order No. 2007-0027-A

Approved on August 28,2008

Administrative Order No. 2007-0027

Approved on August 22,2007

Administrative Order No. 2007-0027

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

Administrative Order No. 2007-0027

The current implementing rule of RA No. 4688

Administrative Order No. 2007-0011

Repeal of A.O. 118-B series of 1992, entitled "Rules and Regulations Governing the Accreditation of Clinical Laboratories for the Training of Medical Technology Interns"

Administrative Order No. 2007-0011

Approved on April 4, 2007

Administrative Order No. 59, Series of 2001

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

Administrative Order No. 59, Series of 2001

Approved on November 19, 2001

Administrative Order No. 393,- E series 2000

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. 393,- E series 2000

Designation of five National Reference Laboratories(NRLs) to undertake the functions of the Bureau of Research and Laboratories (BRL)

Administrative Order No. 393,- E series 2000

Approved on November 14, 2000

Administrative Order No. 118,-B series 1992

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

Administrative Order No. 118,-B series 1992

Approved on March 16, 1992

Bureau Order No. 04, series of 1990

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

Administrative Order No. 49,-B series 1988

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

Administrative Order No. 49,-B series 1988

Approved on October 24, 1998

CLASSIFICATION OF CLINICAL LABORATORIES IN THE PH

OWNERSHIP

FUNCTION

INSTITUTIONAL CHARACTER

SERVICE CAPACITY

CLASSIFICATION OF CLINICAL LABORATORIES IN THE PH

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 ownership, function, institutional character, and service capacity.

OWNERSHIP

GOVERNMENT-OWNED LABORATORIES

PRIVATE LABORATORIES

GOVERNMENT-OWNED LABORATORIES

maintained, partially or wholly, by either the national or local government.

PRIVATE LABORATORIES

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

FUNCTION

CLINICAL PATHOLOGY

ANATOMIC PATHOLOGY

CLINICAL PATHOLOGY

provides diagnosis through tests involving clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetics, toxicology, and therapeutic drug monitoring is classified as a laboratory with a clinical pathology function.

ANATOMIC PATHOLOGY

provides diagnosis through surgical, immunology, histopathologic, cytologic, autopsy procedure, forensic, and molecular pathologic techniques, it is a laboratory with an anatomic pathology function.

INSTITUTIONAL CHARACTER

INSTITUTION-BASED CLINICAL LABORATORY

FREE-STANDING LABORATORY

INSTITUTION-BASED CLINICAL LABORATORY

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

FREE-STANDING LABORATORY

it has no affinity with any other institution

SERVICE CAPACITY

primary,

secondary,

tertiary,

limited-service capability

Primary clinical laboratories

offer standard laboratory procedures

Primary clinical laboratories

10 sq. m minimum

Primary clinical laboratories

routine hematology

Primary clinical laboratories

urinalysis

Primary clinical laboratories

fecalysis

Primary clinical laboratories

blood typing

Secondary clinical laboratories

minimum service capabilities of a primary laboratory with added services

Secondary clinical laboratories

20 sq. m minimum

Secondary clinical laboratories

routine chemistry analysis

Secondary clinical laboratories

cross-matching

Secondary clinical laboratories

Gram staining

Secondary clinical laboratories

KOH preparations

Tertiary clinical laboratories

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

special chemistry procedures

special hematology including

coagulation procedures

immunology and

culture and sensitivity procedures

Tertiary clinical laboratories

60 sq. m minimum

limited -Service Capability

institution-based

limited -Service Capability

Dialysis centers

limited -Service Capability

Social Hygiene Clinics

Special Clinical Laboratory

Assisted reproduction technology

Molecular and cellular technology

Molecular Biology

Molecular Pathology

Forensic Pathology

Anatomic Pathology

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 and for which preventive or therapeutic interventions are OFTEN available.

RG-3

Agents that are associated with serious or lethal human diseases for which preventive or therapeutic interventions may be available.

RG-4

Agents that are likely to cause SERIOUS or LETHAL human diseases for which 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

handle organisms which are considered by the WHO as Risk Group 1, i.e., those that are unlikely to cause human diseases.

BIOSAFETY LEVEL 1 LABORATORIES

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

BIOSAFETY LEVEL 1 LABORATORIES

personnel are supervised by a scientist with previous training in microbiology or a related field.

BIOSAFETY LEVEL 2 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

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

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 3 LABORATORIES

access to the laboratory is controlled to prevent potentially infectious aerosols from escaping to the environment.

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

provided with a specialized ventilation and waste management system.

BIOSAFETY LEVEL 4 LABORATORIES

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

Licensing

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

Licensing

also called LTO (License to Operate)

Department of Health (DOH)

responsible for the regulation of operations of Clinical Laboratories.

annually

As a general rule, any person, firm, or corporation operating and maintaining clinical laboratory shall register and secure a license _____ through HSFRB