[MTLE] Unit 3: RA 4688

RA 4688

Clinical Laboratory Law

June 18, 1966

Date of approval of the RA 4688

President Ferdinand Marcos Sr.

Who ratified the RA 4688

RA 4688

Promulgated for the purpose of preventing the operation and maintenance of substandard, improperly managed and poorly equipped clinical laboratories

RA 4688

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

Department Of Health

Organization for registration for operation and maintenance of clinical laboratories

8 sections

How many sections does RA 4688 have

Registration and License

Section 1 of RA 4688

Authorized Person

Section 2 of RA 4688

Enforcement

Section 3 of RA 4688

Penalty

Section 4 of RA 4688

Separability Clause

Section 5 of RA 4688

Funding

Section 6 of RA 4688

Repealing clause

Section 7 of RA 4688

Effectivity

Section 8 of RA 4688

Section 1

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: Provided, That government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories.

Annually;

Office of the Secretary of Health

Acc to Sec 1 of RA 4688, where and how frequent should a clinical laboratory register and secure a license

extensions of government regional or central laboratories;

doing routine or minimum laboratory examinations

Acc to Sec 1 RA 4688, they shall be exempted from the provisions of the law if their services are _________________

Physician;

Secretary of Health

RA 4688 Section 2:

It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a ______________ duly qualified in laboratory medicine and authorized by the_____________, such authorization to be renewed annually

Physician (authorized by Sec of Health)

According to RA 4688 Section 2, who is professionally in-charge of laboratory

Annually

According to RA 4688 Section 2, how frequent should the authorization of in-charge physician be done

Secretary of Health, Bureau of Research and Laboratories

Acc to RA 4688 Section 3:

The _____________ shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions

Secretary of Health, Bureau of Research and Laboratories

Acc to RA 4688 Section 3:

who is responsible for enforcing the provisions of this law and they are also allowed to issue rules and regulations to carry out its provisions

1) Imprisonment of 1month-1year

2) Fine of 1000-5000pesos

3) both

According to RA 4688 Section 4, what is the punishment of anyone, any firm or corporation that violates any provisions of this Act, or the rules and regulations issued thereunder by the Secretary of health

Court

According to RA 4688 Section 4,

the punishment of violator is at the discretion of _________

Section 5 of RA 4688

"If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof"

50, 000 pesos

RA 4688 SECTION 6.

The sum of ______________ pesos, or so must thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act

Section 7

"All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed"

June 18 1966

Date of approval of RA 4688

Implementing Guidelines of RA 4688

Administrative Order No. 201, Series of 1973

Administrative Order No. 290, Series of 1976

Administrative Order No. 52, Series of 1983

Administrative Order No. 49-B, Series of 1988

Executive Order No. 102, Series of 1999

Administrative Order No. 2001-0059

EO 102 S. 1999

Executive order for the redirection of the functions and operations of the DOH

Administrative Order No. 2001-0059

Administrative order for the rules and regulations Governing the Establishment, Operations and Maintenance of Clinical Laboratories in the Philippines

Current Implementing Guidelines of RA 4688

Administrative Order No. 2007-0027

Administrative Order No. 2007-0027-A

Administrative Order No. 2008-0002

Administrative Order No. 2008-0007

Administrative Order No. 2007-0027

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

Administrative Order No. 2007-0027-A

Amendment to Administrative Order No. 2007-0027

Administrative Order No. 2008-0002

Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities

Administrative Order No. 2008-0007

Schedule of Fees for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories

Health Facilities and Services Regulatory Bureau

Specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories

formerly BHFS (Bureau of Health Facilities & Services)

located at Building 15, DOH San Lazaro Compound, Rizal Ave., Sta. Cruz, Manila

Old: AO 2007-0027

New: AO 2021-0037

Administrative order signed by then DOH Sec. Francisco Duque

promulgated to prescribe a revised minimum standard for clinical laboratories

ensure accuracy and precision of laboratory examinations in order to safeguard public health and safety

AO 2007-0027

ensure accuracy and precision of laboratory examinations in order to safeguard public health and safety

Advances in Technology

Necessitates the need to update the minimum standards and technical requirements for clinical laboratories

DOH Sec. Francisco Duque

Who signed the AO 2007-0027 and AO 20221-0037

AO 59 s. 2001

Rules and Regulation Governing the Establishment, Operation and Maintenance of Clinical Laboratory in the Philippines

One of the regulatory issues of RA 4688 that is no longer relevant

Government Clinical Laboratories doing microscopy work for specific DOH programs (Malarial screening, acid-fast bascili STIs, Pap smears)

Who are exempted in the provisions of AO 2007-0027 or AO 2021-0037 (NEW)

Applicant

natural or juridical person who intends to operate a clinical laboratory

BHFS

Bureau of Health Facilities and Services

CHD

Center for Health Development

Clinical Laboratory

facility where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases

True

T/F:

Acc to AO 2007-0027, other functions of clinical laboratory is to provide consultative advisory services covering all aspects of laboratory investigation including the interpretation of results and advise on further appropriate investigations

True

T/F:

Acc to AO 2007-0027, facilities conducting pre-analytical procedures are considered to be part of clinical laboratory

Critical Values

panic values originally described by Lundberg as "life- threatening" unless something is done promptly and for which some corrective action could be undertaken

Lundberg

panic values originally described by _________ as "life- threatening" unless something is done promptly and for which some corrective action could be undertaken

DOH

Department of Health

EQAP

External Quality Assessment Program;

program where participating laboratories are given unknown samples for analysis

Inspection Tool

checklist used by regulatory officers during inspection visits to evaluate compliance of clinical laboratory to minimum standards and technical requirements

Institution

corporate body or establishment organized for an educational, medical, charitable or similar purpose

License

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

Licensee

individual, agency, partnership or corporation to whom the license is issued and upon whom rests compliance

LTO (or ATO in BB)

License to Operate; also refers to the license

Mobile Clinical Laboratory

laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location; shall have a base laboratory

Monitoring Examination

tests done in series on patients as a guide for treatment or follow-up of their condition

NRL

National Reference Laboratory;

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

NRL

Responsible for confirmatory testing, surveillance, conflicting results, training, research implementation of EQAS, evaluation of diagnostic kits and reagents

True

T/F:

NRL May or may not be part of a general clinical laboratory

NRL

Considered as the highest-level laboratories in the country whose primary role is to perform highly complex procedures

Department Order No. 202-0820

The department order for the 6 designated hospitals of DOH as NRL

National Kidney and Transplant Institute (NKTI)

NRL for Hematology, Immunohematology, Urinalysis

STD/AIDS Central Cooperative Laboratory (SACCL) or San Lazaro Hospital

NRL for Serology

STD/AIDS Central Cooperative Laboratory (SACCL) or San Lazaro Hospital

NRL for HIV/AIDs, Hepatitis and STIs

Lung Center of the Philippines (LCP)

NRL for Clinical Chemistry

Lung Center of the Philippines (LCP)

NRL for anatomic pathology and Biochemistry

East Avenue Medical Center (EAMC)

NRL for Drug Testing, Water Microbiology, Micronutrient Assay

Research Institute of Tropical Medicine (RITM)

NRL for Microbiology and Parasitology

Research Institute of Tropical Medicine (RITM)

NRL for

Dengue, Influenza, Tuberculosis

Mycobacteria, Malaria,

Parasites, Bacterial Enteric diseases

measles, and other exanthems

Mycology

Enteroviruses

Antimicrobial resistance Resistance

Philippine Heart Center

NRL for clinical chemistry

✔ Ensuring quality assurance in clinical chemistry testing.

✔ Providing confirmatory testing for clinical chemistry analytes (e.g., glucose, cholesterol, enzymes, and electrolytes).

✔ Conducting research and training related to clinical chemistry.

✔ Monitoring proficiency testing programs for clinical chemistry laboratories nationwide.

DPO No. 2009-5148

The Philippine Heart Center is designated as NRL through what DPO

POL

Physician's Office Laboratory;

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

POCT

Point of Care Testing;

diagnostic testing at or near the site of patient care rather than in clinical laboratory; includes bedside testing, outpatient and home care

Routine Tests

Basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately upon completion

Satellite Testing Site

any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

STAT Tests

done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure. STAT is an abbreviation for sta'tim which means immediately.

Sta'tim

Stat is an abbreviation for what

1) Government

2) Private

Classification of Laboratories (by Ownership)

Government

operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipal), any other political unit or any department, division, board or agency thereof

Private

owned, established and operated by any individual, corporation, association or organization

1) Clinical Pathology

2) Anatomic Pathology

Classification of Laboratories (by Function)

Clinical Pathology

includes Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring and other similar disciplines

Anatomic Pathology

includes Surgical Pathology, lmmunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology

1) Institution Based

2) Free Standing

Classification of Laboratories (by Institutional Character)

Institution Based

a laboratory that operates within the premises and as part of an institution

such as but not limited to: hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center

Free-Standing

a laboratory that does not form part of any other institution

1) General Clinical Laboratory

2) Special Clinical Laboratory

Classification of Laboratories (by Service Capability)

General Clinical Laboratory

Includes Primary, Secondary Tertiary and Limited-Service Capability (institution based) laboratory

Special Clinical Laboratory

a laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory

Primary Laboratory

Service Capabilities:

Routine Hematology

Complete Blood Count

Hemoglobin

Hematocrit

WBC Count

WBC Differential Count

Qualitative Platelet Determination

Routine Urinalysis

Routine Fecalysis

Blood Typing – for hospital based

Secondary Laboratory

Routine Clinical Chemistry

• Glucose

• Blood Urea Nitrogen

• Uric Acid

• Creatinine

• Total Cholesterol

Quantitative Platelet Determination

Cross Matching – for hospital based

Gram Staining – for hospital based

KOH – for hospital based

+ all primary lab services

Tertiary Laboratory

Special Chemistry

Special Hematology, including coagulation procedures

Immunology

Microbiology

Culture and Sensitivity

aerobic and anaerobic (for hospital based)

aerobic or anaerobic (for non-hospital based)

+ all primary and secondary labs

True

T/F:

Acc to AO 2007-0027, any laboratory licensed under any category can be permitted to perform services other than stipulated, provided that they comply with the requirements with respect to staff, equipment, reagent, and supplies for such additional services listed in the LTO

Limited Service Capability Laboratory

Provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics

Standards and technical requirements of DOH-HFSRB

LTO shall be issued only to clinical laboratories that comply with the ____________