Republic Act 4688
A.O 59 S. 2001
Clinical Laboratory Law
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
A.O 59 S. 2001
Rules and regulations governing the establishment, operation and maintenance of clinical laboratories in the Philippines
Section 1 Title :
Rules and regulations governing the establishment, operation and maintenance of clinical laboratories in the Philippines
Section 2 Authority
Rules and regulations are issued to implement R.A 4688; Clinical Laboratory consistent E.O 102 s. 1999: Redirecting the functions and operations of DOH. The DOH, through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations.
Section 3 Purpose
To protect and promote health of people by ensuring availability of clinical laboratory that are PROPERLY MANAGED with adequate resources, with effective and efficient performance through compliance with quality standards.
Section 4 Scope
Regulations shall apply to all entities performing the activities and functions of clinical lab which shall include the examination and analysis of any or all samples of human and other related tissues, fluids, secretions, excretions, radioactive of other materials form the human body for the determination of the existence of pathogenic organisms, pathologic processes/conditions in the person from whom such samples are obtained.
Regulations DO NOT INCLUDE GOVERNMENT LABORATORY during lab examinations limited to acid fast bacilli microscopy, malaria screening and cervical cancer screening, provided their services are declared as extension of a licensed government clinical laboratory.
Section 5 Classification of Laboratories
By Function:
Clinical Pathology- includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Blood Banking, Lab Endocrinology, Toxicology and Therapeutic Drug Monitoring and other similar disciplines.
Anatomic Pathology- Includes Serological Pathology, Immunohispathology, Cytology , Autopsy and Forensic Pathology
By Institutional Character:
Hospital-Based- a laboratory the operates within the hospital
Non- Hospital- Based- a laboratory that operates on its own
Primary- provides minimum capabilities such as:
Routine Hematology (CBC), Routine Urinalysis, Routine Fecalysis , Blood Typing- Hospital based, Quantitative platelet determination- hospital-based
2. Secondary- provides the services capabilities of the primary lab and the following:
Routine Clinical Chemistry- includes Blood Glucose Substance Concentration, BUN, BUA, Blood Creatine Concentration, Blood Total Cholesterol Concentration
3. Tertiary- provides the service capabilities of the secondary plus the floowing:
Special Chemistry, Special hematology ,serology and Microbiology
Section 6 Policies
An approved permit to construct and design lay-out of a clinical laboratory shall be secured from BHFS prior to submission of an application for a Petition to Operate.
No clinical laboratory shall be constructed unless plans have been approved and construction permit issued by the BHFS.
A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements (annex A)
The clinical laboratory shall be organized and managed to provide effective and efficient laboratory services.
The clinical laboratory shall provide adequate and appropriate safety practices for its personnel and clientele.
Section 7 Requirements and Procedures for Application of Permit to Construct and License to Operate.
Application for Permit to Construct: The following are the documents required:
• Letter of Application to the Director of BHFS
• Four (4) sets of Site Development Plans and floor Plans approved by an architect and/or engineer.
• DTI/SEC Registration (for private clinical laboratory)
2. Application for new license: A duly notarized application form “Petition to Establish, Operate, and Maintain a clinical Laboratory” (Annex B), shall be filed by the owner or his duly authorized representative at the BHFS.
3. Application for renewal of license: A duly notarized application form “Application for Renewal of License to Establish, Operate and Maintain a clinical Laboratory” (Annex C), shall be filed by the owner or his duly authorized representative at the respective CHD
Renewal of License:
Application for renewal of license shall be filed within 90 days before the expiry date of the license described as follows:
Schedule of Application for renewal of license
10, 11, 12, CARAGA and ARMM
4 Permit and License Fees:
A non-refundable license fee shall be charged for application for permit to construct, and for license to operate a government and private clinical laboratory.
A non-refundable fee shall be charged for application for renewal of license to operate.
All fees shall be paid to the cashier of the BHFS/CHD.
All fees shall follow the current prescribed schedules of fees of the DOH.
A penalty of one thousand pesos (P1, 000.00) for late renewal shall be charged in addition to the renewal fee for all categories if the application is filed during the next two (2) months after expiry date.
An application received more than two (2) months after expiry date shall be fined one hundred pesos (P100.00) for each month thereafter in addition to the p1, 000.00 penalty.
• Each license shall make available to the Director of the BHFS/CHD or his duly authorized representative(s) at any reasonable time, the premises and facilities where the laboratory examinations are being performed for inspection.
• Each license shall make available to the Director of the BHFS/CHD or his duly authorized representative(s) all pertinent records.
• Clinical laboratories shall be inspected every two (2) years or as necessary.
7. Monitoring:
All Clinical laboratories shall be monitored regularly and records shall be made available to determine compliance with these rules and regulations.
The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time.
All clinical laboratories shall make available to the Director of the BHFS or his duly authorized representative(s) records for monitoring.
The license shall be issued by the Director of the CHD or his authorized representative, if the application is found to be meritorious.
9. Terms and Conditions of License:
• The license is granted upon compliance with the licensing requirements.
• The license is non-transferable.
• The owner or authorized representative of any clinical laboratory desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in writing at least 15 days before actual transfer.
• The laboratory in its new location shall be subject to re-inspection and shall comply with the licensing requirements.
• An extension laboratory shall have a separate license.
• Any change affecting the substantial conditions of the license to operate a
• laboratory shall be reported within 15 days in writing by the person(s) concerned, to the BHFS/CHD for notation and approval. Failure to do so will cause the revocation of the license of the clinical laboratory.
• The clinical laboratory license must be placed in a conspicuous location/area within the laboratory.
Section 8 Violations
1. The License to operate a clinical laboratory shall be suspended or revoked by the Secretary of Health upon violation of R.A. 4688 or the Rules and Regulations issued in pursuance thereto.
2. The following acts committed by the Owner, President, Managers, Board off Trustees/Director, Pathologist or its personnel are considered violations.
A. Operation of a clinical laboratory without a certified pathologist or without a registered medical technologist.
B. Change of ownership, location, and head of laboratory or personnel without informing the BHFS and/or the CHD.
C. Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the BHFS during reasonable hours
E. Any act or omission detrimental to the public
3. The Provincial, City and Municipal Health Officers are authorized to report to the CHD and BHFS the existence of unlicensed clinical laboratories or any private party performing laboratory examinations without proper license and/or violations to these rules & regulations.
Section 9 Investigation of Charges or Complaints
The BHFS/CHD or his duly authorized representative(s) shall investigate the complaint and verify if the laboratory concerned or any of its personnel is guilty of the charges.
1. If upon investigation, any person is found violating the provisions of R.A. 4688, or any of these rules and regulations, the BHFS/CHD or his duly authorized representative(s) shall suspend, cancel or revoke for a determined period of time the license, as well as the authority of the offending person(S), without prejudice to taking the case to judicial authority for criminal action.
2. Any person who operates a clinical laboratory without the proper license from the Department of Health shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1 year or a fine of not less than P1, 000.00 and not more than P5, 000.00 or both at the discretion of the court. Provided, however, that if the offender is a firm a corporation, the Managing Head and/or owner/s thereof shall be liable to the penalty imprisoned herein.
3. Any clinical laboratory operating without a valid license or whose license has been revoked/cancelled shall be summarily closed upon order issued by the BHFS.CHD or his duly authorized representative. The BHFS/CHD may seek the assistance of the law enforcement agency to enforce the closure of any clinical laboratory.
Section 10 Modification and Revocation of License
A license maybe revoked, suspended or modified in full or in part for any material false statement by the applicant, or as shown by the record of inspection or for a violation of, or failure to comply any of the terms and conditions and provisions of these rules and regulations.
No license shall be modified, suspended or revoked unless prior notice has been made and the corresponding investigation conducted except in cases of willful, or repeated violations hereof, or where public health interest or safety requires otherwise.
Section 11 Repealing Clause
These rules and regulation shall supersede ail other previous official issuances hereof.
Section 12 Publication of List of Licensed Clinical Laboratories:
A list of licensed clinical laboratories shall be published annually in a newspaper of general circulation.
Section 13 Effectivity
These rules and regulations shall take effect 15 days after its publication in the Official Gazettte, or in a newspaper of general circulation.
Technical Standards and Minimum Requirements
The Clinical Laboratory shall be managed by a licensed physician certified by the Philippine Board of Pathology.
*In areas where pathologists are not available, a physician with a three (3) months training on clinical laboratory medicine, quality control and laboratory management, may manage a primary/secondary category clinical laboratories. The BHFS shall certify such training.
The clinical laboratory shall employ qualified and adequately trained personnel. Work assignment shall be consistent with the qualification of the concerned personnel.
*A clinical laboratory shall have sufficient number of registered medical technologists proportional to the workload and shall be available at all times during hours of laboratory operation. For the hospital-based clinical laboratory, there shall be at least one registered medical technologist per shift to cover the laboratory operation.
There shall be staff development and appropriate continuing education program available at all levels of organization to upgrade the knowledge, attitudes and skill of staff.
1. The clinical laboratory shall be well-ventilated, adequately lighted, clean and safe.
2. The working space shall be sufficient to accommodate its activities and allow for smooth and coordinated work flow.
There shall be an adequate water supply.
The working space for all categories of clinical laboratories (both hospital and non-hospital-based) shall have at least the following measurements:
Tertiary (to include a separate, enclosed and adequately ventilated room for Microbiology)
There shall be provisions for sufficient number and types of appropriate equipment/instruments in order to undertake all the activities and laboratory examinations. There equipment shall comply with safety requirements.
All those in Primary Category plus the following:
All those in Secondary Category plus the following:
Microhematocrit centrifuge
Photometer or its equivalent
Microscope with oil immersion objective
Water bath or its equivalent
Hemoglobinometer or its equivalent
Serofuge or its equivalent
Differential blood cell counter or its equivalent
Biosafety cabinet or its equivalent
For other laboratory examinations being performed, the appropriate equipment necessary for performing such procedures shall be made available
GLASSWARES/REAGENT/SUPPLIES
All categories of clinical laboratories shall provide adequate and appropriate glass wares, reagents and supplies necessary to undertake the required services.
There shall be provisions for adequate and efficient disposal of waste following guidelines of the Department of Health and the local government.
Internal Quality Control Program
-There shall be a documented, continuous competency assessment program for all laboratory personnel
-The program shall provide appropriate and standard laboratory methods, reagent and supplies and equipment.
-There shall be a program for the proper maintenance and monitoring of all equipment.
The program shall provide for the use of quality control reference materials.
External Quality Control Program
-All clinical laboratories shall participate in an External Quality Assurance Program given by designated National Reference Laboratory and/or other recognized reference laboratories.
-A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of license.
-Any refusal to participate in an External Quality Assurance Program given by the designated National Reference Laboratories shall be one of the bases for suspension/revocation of the license of the laboratory
REPORTING
Laboratory requests shall be constructed as consultation between the requesting physician and the pathologist of the laboratory and as such laboratory results shall be released accordingly:
All laboratory reports on various examinations of specimens shall bear the name of the registered medical technologist and the pathologist and duly singed by both.
2. No person in the clinical laboratory shall issue a report, orally or in writing, whole or portions, thereof without a directive from the pathologist or his authorized associate to the requesting physician or his authorized representative except in emergency cases when the results may be released as authorized by the pathologist.
Recording
There shall be a system of accurate recording to ensure quality results.
There shall be an adequate and effective system of recording requests and reports of all specimens submitted and examined.
There shall be provisions for filing, storage and accession of all reports.
All laboratory records shall be kept on file for at least one (1) year.
*Records of anatomic and forensic pathology shall be kept permanently in the laboratory
LABORATORY FEES
The laboratory and professional fees to be charged for a laboratory examination shall be at the prevailing rates.
1. The rates shall be within the range of the usual fees prevailing at the time and the particular place, taking into consideration the cost of testing and quality control of various laboratory procedures.
2. Professional services rendered to the patient in the performance of special procedures or examinations shall be charged separately and not included in the laboratory fee/s.
Requirements For Registration/Operation Of Clinical Laboratories
For private laboratories: Certificate of registration of business name from the Department of trade and Industry and certificate from the Security and Exchange Commission (if Corporation).
Certificate/s from the Philippine Board of Pathology
PRC Board certificate of Medical technologists
A notarized statement that the applicant has complied with all business requirements under existing laws or ordinances in the locality where the laboratory Is located
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