Republic Act No. 4688- CLINICAL LABORATORY ACT OF 1966

RA 4688 is also known as the?

CLINICAL LABORATORY ACT OF 1966

RA 4688 was approved on?

JUNE 18, 1966

RA 4688 was promulgated for the purpose of:

PREVENTING (THE OPERATION AND MAINTENANCE OF SUBSTANDARD, IMPROPERLY MANAGED AND POORLY EQUIPPED CLINICAL LABORATORIES.)

RA 4688: Section 1?

- clinical laboratory shall register and secure a license annually at the office of the Secretary of Health

- 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

What is the complete title of 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

RA 4688: Section 2?

- unlawful for any person to be professionally in-charge (HEAD) of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health

- authorization to be renewed annually

- No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician

RA 4688: Section 3?

The Secretary of Health, through the Bureau of Research and Laboratories (BRL) 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.

RA 4688: Section 4?

- 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 with imprisonment for not less than 1 month but not more than 1 year

- or by a fine of not less than 1,000 pesos nor more than 5,000 pesos

- or both such fine and imprisonment, at the discretion of the court.

RA 4688: Section 5?

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.

RA 4688: Section 6?

The sum of fifty thousand pesos (50,000), or so much 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.

RA 4688: Section 7?

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

RA 4688: Section 8?

This Act shall take effect upon its approval.

Administrative Order no.59 s. 2001?

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

Administrative Order 59 s. 2001: Section 1?

Title

Administrative Order 59 s. 2001: Section 2?

Authority

Administrative Order 59 s. 2001: Authority?

- issued to implement R.A. 4688: Clinical Laboratory Law consistent with E.O. 102 series 1999: Redirecting the Functions and Operations of the Department of Health

- DOH, through BHFS in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations.

BHFS?

Bureau of Health Facilities and Services

Administrative Order 59 s. 2001: Section 3?

Purpose

Administrative Order 59 s. 2001: Purpose?

promulgated to protect and promote the health of the people by ensuring availability of clinical laboratories that are:

- properly managed with adequate resources

- with effective and efficient performance through compliance

- with quality standards.

Administrative Order 59 s. 2001: Section 4?

Scope

Administrative Order 59 s. 2001: Section 4: Scope- applies to all entities performing the functions of clinical laboratories such as:

- EXAMINATION AND ANALYSIS (Examination and analysis of human samples such as tissues and body fluids)

- DETERMINATION (Determination of pathogenic organisms, processes and conditions in patient samples)

Administrative Order 59 s. 2001: Section 4: Scope- does not apply to GOVERNMENT LABS performing:

AFB (Acid-Fast Bacilli) MICROSCOPY,

MALARIA SCREENING,

CERVICAL CANCER SCREENING

(provided that these will be declared as an extension of services of a licensed government clinical laboratory)

Administrative Order 59 s. 2001: Section 5?

Classification of Laboratories

Administrative Order 59 s. 2001: Section 5: What are the 3 Classification of Laboratories?

- Classification by Function

- Classification by Institutional Character

- Classification by Service Capability

Classification of Laboratories by FUNCTION?

- ANATOMIC PATHOLOGY

- CLINICAL PATHOLOGY

What are sections under Clinical Pathology?

Hematology,

Clinical Chemistry, Microbiology, Parasitology, Mycology,

Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring

and other similar disciplines.

What are sections under Anatomic pathology?

Surgical Pathology, Immunohistopathology,

Cytology,

Autopsy

Forensic Pathology

Classification of Laboratories by INSTITUTIONAL CHARACTER

- Hospital-based laboratory

- Non-hospital-based laboratory

What is a Hospital-based laboratory?

a laboratory that operates within a hospital.

What is a Non-hospital-based laboratory?

a laboratory that operates on its own.

Classification of Laboratories by SERVICE CAPABILITY

- Primary (10 sq. m.)

- Secondary (20 sq. m.)

- Tertiary (60 sq. m.)

A primary laboratory performs minimum services such as:

ROUTINE HEMATOLOGY (CBC),

ROUTINE CLINICAL MICROSCOPY PROCEDURES:urinalysis and fecalysis

(for primary hospital-based)

BLOOD TYPING

QUANTITATIVE PLATELET DETERMINATION

A secondary laboratory provides minimum services of a PRIMARY LAB and the following:

ROUTINE CLINICAL CHEMISTRY (Blood Glucose, BUN, SUA, Serum Creatinine, Total Blood Cholesterol)

CROSS MATCHING

A tertiary laboratory provides minimum services of a SECONDARY LAB and the following:

SPECIAL CLINICAL CHEMISTRY,

SPECIAL HEMATOLOGY,

IMMUNOLOGY AND SEROLOGY,

MICROBIOLOGY

Administrative Order 59 s. 2001: Section 6?

Policies

Before a petition for a License to operate will be given a lab must:

- DESIGN (Get a BHFS approved design lay-out of the laboratory),

- PERMIT (Get a BHFS approved permit to construct)

Administrative Order 59 s. 2001: Section 7?

Requirements and Procedures for application of Permit to Construct and License to Operate

What are the requirements for application to construct?

LETTER (Application letter to BHFS Director),

4 SETS OF PLANS (FOUR (4) Architect/Enginner approved sets of Site Development Plans and Floor Plans),

DTI/SEC Registration (FOR PRIVATE LABS)

DTI means?

DEPARTMENT OF TRADE AND INDUSTRY

SEC means?

SECURITIES AND EXCHANGE COMMISSION

What are the requirements for application for new license?

PETITION ("Petition to Establish, Operate and Maintain a Clinical Laboratory" filed at the BHFS by the owner or his representative.)

What are the requirements for application for renewal of license?

APPLICATION ("Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory" filed at the respective CHD by the owner or his representative.)

CHD means?

CENTERS FOR HEALTH DEVELOPMENT

The renewal of license shall be filed ______ days before the expiry date of the license

90

What are the penalties for late renewal of license if filed 2 MONTHS after expiry date?

RENEWAL FEE + P1,000

What are the penalties for late renewal of license if filed more than 2 MONTHS after expiry date?

RENEWAL FEE + P1,000 + P100 for every month after the 2 months

Who conducts inspections of laboratories?

BHFS/CHD DIRECTOR (or any of his/her representative)

Inspection of laboratories is to be conducted every _________

2 YEARS or as necessary.

What are the conditions for the inspection of laboratories?

- INSPECTED AT ANY REASONABLE TIME,

- PERTINENT RECORDS MUST BE MADE AVAILABLE,

- INSPECTION IS EVERY 2 YEARS

Laboratories that would like to transfer locations shall give a written notice _________ before the actual transfer.

15 DAYS

True or False: An extension laboratory shall have a separate license?

True

A LTO is ___________ which means it cannot be used for another clinical laboratory even if the owner is the same

NON-TRANSFERABLE

Extension laboratories are laboratories which are within a ___________ from the Main laboratory

100 sq m radius

Laboratories which exceed the 100 sq m radius are known as...?

SATELLITE LABORATORIES

Terms and Conditions of Issuance of License to Operate?

COMPLIANCE OF REQUIREMENTS,

NON-TRANSFERABLE,

WRITTEN NOTICE BEFORE TRANSFER,

RE-INSPECTION AFTER TRANSFER,

EXTENSION LABS ARE SEPARATE,

REPORT CHANGE IN LABS

LTO must always me placed in a ____________________.

CONSPICUOUS AREA

Administrative Order 59 s. 2001: Section 8?

VIOLATIONS

License to operate will be revoked/suspended by the ______________

SECRETARY OF HEALTH

LTO will be taken if laboratory personnel and owner will commit the following:

NO PATHO AND MTS (Operate without a licensed Pathologist and licensed Medical Technologists.),

CHANGE W/O INFORMING (Change ownership, location or laboratory head without informing the BHFS),

REFUSAL (Refusal of inspection within reasonable hours),

GROSS NEGLIGENCE (Gross negligence),

DETRIMENTAL (Any act or omission detrimental to the public)

Institutions authorized to report unlicensed laboratories or laboratories operating with unlicensed staff:

- PROVINCIAL HEALTH OFFICERS,

- CITY HEALTH OFFICERS,

- MUNICIPAL HEALTH OFFICERS

Administrative Order 59 s. 2001: Section 9?

INVESTIGATION OF CHARGES AND COMPLAINTS

Who investigates charges and complaints?

BHFS/CHD DIRECTOR (or any of his/her representatives)

What can the BHFS/CHD DIRECTOR do?

- SUSPEND/REVOKE LTO OR LICENSE OF PERSONNEL,

- CHARGE FOR CRIMINAL ACTION

Laboratories operating without an LTO shall be penalized with:

FINE,

IMPRISONMENT,

BOTH

Range of IMPRISONMENT if laboratory is caught operating without at LTO:

NOT LESS THAN 1 MONTH AND NOT MORE THAN 1 YEAR

Range of FINE if laboratory is caught operating without at LTO:

NOT LESS THAN P 1,000 AND NOT MORE THAN P 5,000

If the laboratory is owned by a FIRM OR CORPORATION, the ______________ will be held liable

OWNER or MANAGING HEAD

Administrative Order 59 s. 2001: Section 10?

MODIFICATION AND REVOCATION OF LICENSE

License to operate shall be modified/revoked/suspended if:

FALSE STATEMENTS (Applicant will give any false statements),

VIOLATIONS (Record of inspection shows violations),

FAILURE TO COMPLY (Lab fails to comply any of the terms of this law)

An LTO will only be modified/revoked/suspended if there is:

PRIOR NOTICE,

INVESTIGATION (A corresponding investigation done)

An LTO will only be modified/revoked/suspended according to the following conditions except for laboratories with ____________________

WILLFUL OR REPEATED VIOLATIONS

Administrative Order 59 s. 2001: Section 11?

REPEALING CLAUSE

Administrative Order 59 s. 2001: Section 12?

PUBLICATION OF LIST OF LICENSED CLINICAL LABORATORIES

A list of licensed Clinical laboratories shall be published _________ in ______ newspaper of general circulation

ANNUALY, ONE

Administrative Order 59 s. 2001: Section 13?

EFFECTIVITY

Administrative Order 59 s. 2001: Section 13: These rules and regulations shall take effect __________ after its publication in the Official Gazette, or in a newspaper of general circulation

15 DAYS

AO 59 s. 2001: What is the Minimum Facilities Required for PRIMARY Laboratory?

- Clinical centrifuge

- Hemacytometer

- Microhematocrit centrifuge

- Microscope with OIO

- Hemoglobinometer or its equivalent

- Differential blood cell counter or its equivalent

AO 59 s. 2001: What is the Minimum Facilities Required for SECONDARY Laboratory?

- Primary laboratory equipment/ instruments

- Refrigerator

- Photometer or its equivalent

- Water bath or its equivalent

- Timer or its equivalent

AO 59 s. 2001: What is the Minimum Facilities Required for TERTIARY Laboratory?

- Secondary laboratory equipment/ instruments

- Incubator

- Analytical balance

- Rotator

- Serofuge or its equivalent

- Autoclave

- Drying oven

- Biosafety cabinet or its equivalent

Who is the laboratory head?

ANATOMICAL AND CLINICAL PATHOLOGIST

In case a Pathologist is not available, _________________ on clinical laboratory medicine, QC and lab management may manage PRIMARY and SECONDARY labs

A PHYSICIAN WITH 3 MONTHS TRAINING

At least __________ per shift per section for Hospital based laboratories

1 RMT

Why should the MICROBIO room be separated?

MT WON'T BE INFECTED,

SAMPLES WON'T BE AFFECTED

What steps do QA involve?

PRE-ANALYTICAL, ANALYTICAL, POST-ANALYTICAL

What does QC involve?

ANALYTICAL

Administrative Order no. 27 series of 2007?

Revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines

AO 27 s. 2007: Objective?

to prescribe a revised minimum standard for clinical laboratories; to ensure accuracy and precision of laboratory examinations in order to safeguard public health and safety

Licensee?

to whom the license is issued

External Quality Assessment Program?

unknown samples are given to the participating laboratories for analysis by the NRL

National Reference Laboratory?

A laboratory in a government hospital which has been designated by the DOH to provide special functions and services

What are the special functions and services of the NRL?

-Confirmatory testing

- Surveillance

- Resolution of conflicts

- Training and research

- Evaluation of kits and reagents

- External quality assessment program

What is the NRL 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; for confirmatory testing of blood units.

- Transfusion Transmissible Infection(Infectious)

- EMERGING and Reemerging disease?

Research Institute for Tropical Medicine (RITM)

What is the NRL for HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls)?

STD-AIDS Cooperative Central Laboratory- SACCL

(San Lazaro Hospital)

What is the NRL for:

- Environmental and Occupational Health; Toxicology and Micronutrient Assay?

- Drug tesing laboratory, Drinking Water Analysis?

East Avenue Medical Center

What is the NRL for Hematology?

National Kidney and Transplant Institute

What is the NRL for Biochemistry?

Lung Center of the Philippines

Critical value?

life threatening results unless something is done promptly and for which some corrective action could be undertaken

Mobile Clinical Laboratory?

a lab testing unit that moves from testing site to another testing site which shall have a base laboratory.

Physician's Office Laboratory?

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

Point of Care Testing?

- diagnostic testing at or near the site of patient care (bedside testing, outpatient and home care)

- required to be under the management and supervision of licensed clinical laboratory of the hospital.