RA 4688

RA No. 4688

Clinical Laboratory Act of 1966

RA No. 4688

Law regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the DOH through the HFSRB

Health Facilities and Services Regulatory Bureau

HFSRB stands for

October 12, 2012

Administrative Order no. 2012-0021

Administrative Order no. 2012-0021

National Framework of the National Health Laboratory Network

Department Memo no. 2009-0086

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

February 3, 2009

Department Memo no. 2009-0086

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 in the Philippines"

August 28, 2008

Administrative Order No. 2007-0027-A

Administrative Order No. 2007-0027

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

August 22, 2007

Administrative Order No. 2007-0027

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. 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

November 14, 2000

Administrative Order No. 393-E series 2000

Administrative Order No. 118-B series 1992

Rules and regulations governing the accreditation if clinical laboratories 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

Government Owned

Laboratories maintained either partially or wholly by either the national or local government

Private

Established or operated by an individual or corporation or association without any connection with the government

Clinical Pathology Function

Provides test involving clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetic, toxicology, and therapeutic drug monitoring

Anatomic Pathology Function

provides diagnosis through surgical, immunology, histopathologic, cytologic, autopsy procedure forensic and molecular pathologic techniques

Institution Based Clinical Laboratory

Operates within institutions like hospitals, schools, medical clinics, and psychiatric facilities.

Free standing

No affinity with any institution

General Clinical Laboratories

Primary, Secondary, Tertiary, Limited Service

Primary

They offer standard laboratory procedure

Secondary

they offer primary lab services plus routine chemistry analysis, cross matching, gram staining, and potassium hydroxide preparation

Tertiary

They offer primary, secondary lab services and special chemistry procedures, special hematology

Limited Service

For institution based only

Special Clinical Laboratories

They offer highly specialized laboratory services that are usually not provided by the general clinical laboratory

Biosafety Level 1

Handle organisms which are considered by the WHO as Risk group 1

Biosafety Level 1

Personnel are expected to wear standard PPE and supervised by a scientist with training in microbiology or related field

Biosafety Level 2

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

PPE plus secondary barriers (sink, waste decontamination facilities to reduce transmission of biohazard waste, and biosafety cabinet)

Biosafety Level 3

Handle indigenous or exotic agents that can be transmitted via respiratory routes and cause severe or sometimes fatal infections (Risk group 3)

Biosafety Level 3

all procedures should be done in safety cabinets with gas-tight aerosol generation chamber

Biosafety Level 4

Handle extremely dangerous and exotic agents that can be transmitted through the air

Biosafety Level 4

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

Biosafety Level 4

Operates in a separate building

License

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

License

also called as LTO or License to Operate

Physician's Office Laboratory

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

Mobile Clinical Laboratory

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

Mobile Clinical Laboratory

Allowed to operate within 100 km radium from its main laboratory

Point of Care testing

is 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

National Reference Laboratory

Is a laboratory in a government hospital designated by the DOH to provide special diagnostic functions and services for specific disease areas

Philippine National Heart Center

Reference laboratory for anatomic pathology for cardiac diseases

National Kidney and Transplant Institute

Reference laboratory for hematology, coagulation tests, immunohematology, immunopathology, anatomic pathology for renal diseases, automated urinalysis

Lung Center of the Philippines

Reference laboratory for clinical chemistry, anatomic pathology for pulmonary diseases

STD/AIDS Cooperative Central Laboratory / San Lazaro Hospital

Screening and confirmatory tests for HIV, syphilis, Hepatitis B and Hepatitis C

Research Institute for Tropical Medicine

Reference laboratory for Dengue, Influenza, Tuberculosis and other Mycobacteria, Malaria and other parasites, Bacterial enteric diseases, measles and other viral exanthems, Mycology, Enteroviruses, Antimicrobial resistance and Emerging Diseases

East Avenue Medical Center

Screening and confirmatory drug tests, water testing potability, analytical toxicology, methemoglobin, hemoglobin, and sulfhemoglobin