RA 4688 THE CLINICAL LABORATORY LAW OF 1966

REPUBLIC ACT NO. 4688

Is the law regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the DOH through the HSFRB

October 12, 2012

when was Administrative Order No. 2012-0021 approved?

Department Memo No. 2009-0086

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

February 3, 2009

when was Department Memo No. 2009-0086 approved?

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"

• 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

August 28,2008

when was Administrative Order No. 2007-0027-A approved?

Administrative Order No. 2007-0027

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

• The current implementing rule of RA No. 4688

August 22, 2007

when was Administrative Order No. 2007-0027 approved?

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"

April 4, 2007

when was Administrative Order No. 2007-0011 approved?

Administrative Order No. 59, Series of 2001

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

November 19, 2001

when was Administrative Order No. 59, Series of 2001 approved?

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)

November 14, 2000

when was Administrative Order No. 393,- E series 2000 approved?

Administrative Order No. 118,-B series 1992

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

March 16, 1992

when was Administrative Order No. 118,-B series 1992 approved?

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"

October 24, 1998

when was Administrative Order No. 49,-B series 1988 approved?

• government owned

• private

Classification of clinical laboratories in the Philippines based on ownership

• clinical pathology

• anatomic pathology

Classification of clinical laboratories in the Philippines based on function

• institution based clinical laboratory

• free standing

Classification of clinical laboratories in the Philippines based on institutional character

• primary

• secondary

• tertiary

• limited service

• special clinical laboratories

Classification of clinical laboratories in the Philippines based on service capacity

Biosafety Level 1

• Handle organisms which are considered by the WHO as Risk Group 1

• Personnel are expected to wear standard PPE (masks, gloves, and laboratory gowns) and supervised by a scientist with training in microbiology or related field

• Special containment systems NOT required

Biosafety Level 2

• Handle a broad spectrum of moderate risk agents or Risk Group 2 organisms Personnel process human-derived specimens (blood, body fluids, tissues, and human cell lines with unknown disease-causing organism)

• PPE + 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 organisms)

• Access to laboratory is controlled to prevent infectious aerosols from escaping to the environment

• ALL procedures should be done in biosafety cabinets with gas-tight aerosol generation chamber

Biosafety Level 4

• Handle extremely dangerous and exotic agents that can be transmitted through the air, have NO available vaccine or therapeutic cure (Risk Group 4)

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

• Provided with a specialized ventilation and waste management system Operates in a separate building

License

Is 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

one year

How long is the validity of the LTO?

False

True or False: LTO must be not be renewed

Physician’s Office Laboratory

is an individual doctors' office/ clinic wherein laboratory examinations are performed, Examinations done are be permitted as long as they are used for monitoring patients

Mobile Clinical Laboratory

is a specialized facility that moves from one testing site to another or has a temporary testing location. It shall have a base laboratory.

Point Of Care Testing

is a diagnostic test at or near the site of patient care rather than in the clinical laboratory. It includes bedside testing, outpatient services and home care.

pathologist

every clinical laboratory must be headed and managed by a?

10 minutes

A single laboratory test is estimated to be processed within?

HFSRB or through the CHD

where is the application for LTO filed?

National Reference Laboratory (NRL)

is a laboratory in a government hospital which has been designated by the DOH to provide special functions and services for specific disease areas.

PHILIPPINE NATIONAL HEART CENTER (PNHC)

Anatomic pathology for cardiac diseases

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI)

Hematology, coagulation tests, immunohematology, immunopathology, anatomic pathology for renal diseases, automated urinalysis

LUNG CENTER OF THE PHILIPPINES (LCP)

Clinical chemistry, anatomic pathology for pulmonary diseases

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

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

RESEARCH INSTITUTE FOR TROPICAL MEDICINE (RITM)

Dengue, influenza, tuberculosis and other mycobacteria, malaria, and other parasites, bacterial enteric diseases, measles and other exanthems, enterovirus, antimicrobial resistance, emerging and re-emerging infections, confirmatory testing for blood donors and blood units, rabies, Japanese encephalitis, and other pathogens that cause meningitis and meningoencephalitis

EAST AVENUE MEDICAL CENTER (EAMC)

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

• medical technologist

• pathologist

who are authorized to sign an official laboratory report?

the secretary of health through the HFSRB

who is tasked to enforce the provisions of the clinical laboratory law and its implementing rules?

Health Facilities and Services Regulatory Bureau

HFSRB

Center for Health Development

CHD

government-owned laboratories

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

private laboratories

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

Clinical Pathology function

tests involving clinical chemistry, hematology, immunohematology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetics, 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 the premises and as part of an institution such as hospital, clinic, school, or medical facility

Free standing clinical laboratory

• has no affinity with any other institution

• ex. Hi-Precision Diagnostics laboratory

Primary clinical laboratory

• offer standard laboratory procedures such as routine hematology, urinalysis, fecalysis, and blood typing

• technical working area must be at least 10 square meters

Secondary clinical laboratory

• are those that provide the minimum service capabilities of a primary laboratory with added services such as routine chemistry analysis, cross matching, gram staining, and KOH preparations

• technical working area must have at least 20 square meters

Tertiary clinical laboratories

• provide the service capabilities of secondary laboratory in addition to the following services: special chemistry procedures, special hematology, coagulation procedures, immunology and culture, and sensitivity procedures

• technical working area must at least be 60 square meters

Special clinical laboratories

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

• assisted reproduction technology, molecular and cellular technology, molecular biology, molecular pathology, forensic pathology, and anatomic pathology

RG-1

what risk group does this virus or diseases belong to: Bacillus subtilis, Escherichia coli K12, adeno-associated virus (AAV)

RG-2

what risk group does this virus or diseases belong to: Staphylococcus aureus, Salmonella sp, Herpes simplex viruses, Adenovirus

RG-3

what risk group does this virus or diseases belong to: Mycobacterium tuberculosis, Bacillus anthracis, HIV

100 km

Mobile laboratories are allowed to operate only within how many km radius from their base laboratory?

True

True or False: All clinical laboratory must participate with External Quality Program (EQP)