unit 2: republic act 4688

• Clinical Laboratory Law

• Comprised of eight (8) sections only

• Approved on June 18, 1966

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from humans 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

Section 1:

shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories

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

Section 2:

No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless

The Secretary of Health, through the Bureau of Research and Laboratories 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

Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished

Section 4:

imprisonment

Section 4:

fine

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

Section 6:

The sum of ___, or so must thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

Redirecting the Functions & Operations of DOH

Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

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

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

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

New Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines

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

• formerly BHFS (Bureau of Health Facilities & Services)

Definition of Terms:

natural or juridical person who intends to operate a clinical laboratory

Definition of Terms:

Center for Health Development

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

External Quality Assessment Program; program where participating laboratories are given unknown samples for analysis

Definition of Terms:

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

Definition of Terms:

ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY

Definition of Terms:

EQUIPMENT/INSTRUMENT S/GLASSWARE/SUPPLIES/ REAGENTS PER AREA OF ACTIVITY/SERVICE CAPABILITY OF GENERAL CLINICAL LABORATORY

Definition of Terms:

PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL LABORATORIES

Definition of Terms:

PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL LABORATORY

Definition of Terms:

CHECKLIST FOR REVIEW OF FLOOR PLANS GENERAL CLINICAL LABORATORY

Definition of Terms:

GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT FOR CLINICAL LABORATORIES

Definition of Terms:

APPLICATION FORM FOR CERTIFICATE OF REGISTRATION FOR RESEARCH AND TEACHING CLINICAL LABORATORY

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

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

Definition of Terms:

done on urgent cases, results of which shall be released immediately, within one (1) hour after the procedure.

Definition of Terms:

A division at the Center for Health Development (CHD) responsible for the issuance of Certificate of Need, Permit to Construct, License to Operate/Authority to Operate, and the conduct monitoring of hospital and health facilities

Definition of Terms:

a permit issued by DOH to an applicant who will establish and operate a hospital or other health facility, upon compliance with required documents; required for hospitals and other health facilities with substantial alteration, expansion, renovation, or for additional services (add-ons) beyond their service capability

Definition of Terms:

refer to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovation

Definition of Terms:

an EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.

Definition of Terms:

refers to CL tests that are either sent-out or outsourced to other DOH-licensed CL with the same or higher service capability.

National Reference Laboratories:

• Hematology

• Immunohematology

• Urinalysis

National Reference Laboratories:

• Serology

National Reference Laboratories:

• Clinical Chemistry

National Reference Laboratories:

• Drug Testing

• Water Microbiology

• Micronutrient Assay

National Reference Laboratories:

• Microbiology

• Parasitology

Classification of Laboratories: By Ownership

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

Classification of Laboratories: By Ownership

privately owned, established and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization

Classification of Laboratories: By Function

• deals with the chemical and cellular analyses of blood and other body fluids

• Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring

Classification of Laboratories: By Function

• provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues

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

Classification of Laboratories: By Function

• deals with the analysis of certain genes, proteins and other molecules in samples from organs, tissues or bodily fluids in order to diagnose disease

Classification of Laboratories: By Institutional Character

• 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

• A laboratory that is located within the premises and operates as part of a DOH licensed health facility.

Classification of Laboratories: By Institutional Character

• a laboratory that does not form part of any other institution

• A laboratory that operates independently and is not attached to any DOH licensed health facility.

(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL

• Routine Hematology

  • Complete Blood Count

    • Hemoglobin

    • Hematocrit

    • WBC Count

    • WBC Differential Count

• Qualitative Platelet Determination

• Routine Urinalysis

• Routine Fecalysis

• Blood Typing (hospital based)

AO 2021-0037:

Primary Laboratory additions

(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL

• Routine Clinical Chemistry

  • Glucose

  • Blood Urea Nitrogen

  • Uric Acid

  • Creatinine

  • Total Cholesterol

• Quantitative Platelet Determination

• Cross Matching (hospital based)

• Gram Staining (hospital based)

• KOH (hospital based)

(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL

• Special Chemistry

• Special Hematology, including coagulation procedures

• Immunology

• Microbiology

  • Culture & Sensitivity

  • Aerobic & Anaerobic (for hospital based)

  • Aerobic or Anaerobic (for non-hospital based)

Classification of Laboratories: By Service Capability: General CL

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

Classification of Laboratories: By Service Capability: General CL

provides services for any of the following, but not limited to: cytology and histopathology

Classification of Laboratories: By Service Capability: General CL

provides services for genetics, immuno/hematopathology and infectious disease. COVID-19 testing laboratories shall be covered by another order.

General Guidelines:

shall be exempted from the licensing requirement but shall be required to register

General Guidelines: Special Laboratories

General Guidelines:

NRL shall be covered by ___

General Guidelines:

POL ___ to secure a LTO

General Guidelines:

POCT (in hospital) required under ___

Specific Guidelines: Human Resources

• Head of Laboratory

• shall have administrative and technical supervision of the activities in the laboratory

Specific Guidelines: Human Resources

• number of staff shall depend on ___

Specific Guidelines: Human Resources

Microscopy, Hematology, Clinical chemistry

Specific Guidelines: Human Resources

Working hours

Specific Guidelines: Human Resources

Manual testing: 8 hours

Specific Guidelines: Human Resources

Manual testing: 12 hours

Specific Guidelines: Human Resources

Automated testing: 8 hours

Specific Guidelines: Human Resources

Automated testing: 12 hours

Specific Guidelines: Physical Facilities: Minimum Technical Working Area

Primary

Specific Guidelines: Physical Facilities: Minimum Technical Working Area

Secondary

Specific Guidelines: Physical Facilities: Minimum Technical Working Area

Tertiary

Specific Guidelines: Physical Facilities: Quality Control Program

criteria for renewal of license

Specific Guidelines: Physical Facilities: Quality Control Program

basis for suspension/revocation of license

Specific Guidelines: Physical Facilities

• Bear the name and signature of Pathologist & RMT

• No report orally or in writing without directive from pathologist or associate except in emergency cases

Specific Guidelines: Physical Facilities

• All requests and reports of all specimens submitted and examined

• Kept in file for at least 1 year

Specific Guidelines: Physical Facilities: Recording

Anatomic and forensic pathology reports

Renewal of LTO:

Hospitals

Renewal of LTO:

Non-hospitals: discount on renewal fee if application completed during this period

Renewal of LTO:

processed not later than ___ after expiration date of LTO

Renewal of LTO:

LTO ___ when failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in license

Inspection:

Licensee shall ensure ___ of CHD Director or authorized representative(s) at any reasonable time

Inspection:

Licensee shall ensure ___ of CHD Director or his authorized representative(s)

Violations:

___ on any clinical lab to participate in EQAP

Violations:

___ (in whole or part thereof) which is not in accordance with documented procedures

Violations:

Permitting unauthorized persons to ___

Violations:

___ from standard test procedure

Violations:

Lending or using the name of licensed laboratory or head or RMT to an ___

Violations:

Unauthorized use of the name and signature of Pathologist and RMT to ___