SECTION 1. Title:

This Administrative Order shall be known as the "Rules and Regulations Governing the Establishment, Operation and Maintenance Of Clinical Laboratories in the Philippines."

SECTION 2. Authority:

These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law consistent with E.O. 102 s. 1999: Redirecting the Functions and Operations of the Department of Health. The Department of Health (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:

These rules and regulations are 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.

SECTION 4. Scope:

4.1 These regulations shall apply to all entities performing the; activities and functions of clinical laboratories which shall include the examination and analysis of any or all samples of human and other related tissues, fluids; secretions, excretions, radioactive, or other materials from the human body for the determination of the existence of pathogenic organisms, pathologic processes or conditions in the person from whom such samples are obtained:

4.2 These regulations do not include government laboratories doing laboratory 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:

5.1 Classification by Function

5.1.1 Clinical Pathology - includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Blood Banking, Laboratory Endocrinology, Toxicology and Therapeutic Drug Monitoring and. other similar disciplines.

5.1.2 Anatomic Pathology - includes Surgical, Pathology, Immunohispathology; Cytology, Autopsy and Forensic Pathology.

5.2 Classification by Institutional Character

5.2.1 Hospital-based laboratory - a laboratory that operates within a hospital.

5.2.2 Non-hospital-based laboratory - a laboratory that operates on its own.

5.3 Classification by Service Capability

5.3.1 Primary - provides the. minimum service capabilities such as:

5.3.1.1 Routine Hematology (Complete Blood Count or CBC) - includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocytes Number Concentration, (White Blood Cell or WBC Count) and Leucocytes Type Number Fraction (Differential Count), Qualitative Platelet Determination.

5.3.1.2 Routine Urinalysis

5.3.1.3 Routine Fecalysis

5.3.1.4 Blood Typing -hospital based

5.3.1.5 Quantitative platelet determination-hospital, based

5.3.2 Secondary - provides the minimum service capabilities of a primary category and the following:

5.3.2.1 Routine Clinical Chemistry - includes Blood Glucose Substance Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration, Blood Total Cholesterol Concentration.

5.3.2.2 Cross matching-hospital based.

5.3.3 Tertiary - provides the secondary service capabilities and the following:

5.3.3.1 Special Chemistry

5.3.3.2 Special Hematology

5.3.3.3 Immunology/Serology

5.3.3.4 Microbiology

SECTION 6. Policies:

6.1 An approved permit, to construct and design lay-out of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a Petition to Operate.

6.2 No clinical laboratory shall be constructed unless plans have been approved and construction permit issued by the BHFS.

6.3 A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements (Annex A).

6.4 The clinical laboratory shall be organized and managed to provide effective and efficient laboratory services.

6.5 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:

7.1 Application for Permit to Construct: The following are the documents required:

7.1.1 Letter of Application to the Director of BHFS

7.1.2 Four (4) sets of Site Development Plans and Floor Plans approved by an architect and/or engineer.

7.1.3 DTI/SEC Registration (for private clinical laboratory)

7.2 Application for new license: A duly notarized application-form "Petition to Establish, Operate and Maintain a Clinical Laboratory" (Annex C), shall be filed by the owner or his duly authorized representative at the BHFS.

7.3 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.

7.3.1 Renewal of License:

Application for renewal of license shall be filed within 90 days before the expiry date of the license described as follows:



Region

Schedule of application for renewal of license

NCR

January to March

1, 2, 3 & CAR

February to April

4, 5, & 6

March to May

10, 11, 12, CARAGA & ARMM

May to July

7.4. Permit and License Fees:

7.4.1 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.

7.4.2 A non-refundable fee shall be charged for application for renewal of license to operate.

7.4.3 All fees shall be paid to the cashier of the BHFS/CHD.

7.4.4 All fees shall follow the current prescribed schedules of fees of the DOH.

7.5 Penalties:

7.5.1 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.

7.5.2 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.

7.6 Inspection:

7.6.1 Each licensee 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.

7.6.2 Each licensee shall make available to the Director of the BHFS/CHD or his duly authorized representative(s) all pertinent records.

7.6.3 Clinical laboratories shall be inspected every two (2) years or as necessary.

7.7 Monitoring:

7.7.1 All clinical laboratories shall be monitored regularly and records shall be made available to determine compliance with these rules and regulations.

7.7.2 The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time.

7.7.3 All clinical laboratories shall make available to the Director of the BHFS or his duly authorized representative(s) records for monitoring.

7.8 Issuance of License:

The license shall be issued by the Director of the CHD or his authorized representative, if the application is found to be meritorious.

7.9 Terms and Conditions of License:

7.9.1 The license is granted upon compliance with the licensing requirements.

7.9.2 The license is non transferable.

7.9.3 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.

7.9.4 The laboratory in its new location shall be subject to reinspection and shall comply with the licensing requirements.

7.9.5 An extension laboratory shall have a separate license.

7.9.6 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.

7.9.7 The clinical laboratory license must be placed in a conspicuous location/area within the laboratory.

SECTION 8. Violations:

8.1 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.

8.2 The following acts committed by the Owner, President, Managers, Board of Trustees/Director, Pathologist or its personnel are considered violations:

8.2.1 Operation of a clinical laboratory without a certified pathologist or without a registered medical technologist.

8.2.2 Change of ownership, location, head of laboratory or personnel without informing the BHFS and/or the CHD.

8.2.3 Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the BHFS during reasonable hours.

8.2.4 Gross negligence.

8.2.5 Any act or omission detrimental to the public.

8.3 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.

9.1 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.

9.2 Any person who operates a clinical laboratory without too 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 or corporation, the Managing Head and/or owner/s thereof shall be liable to the penalty imposed herein.

9.3 Any Clinical Laboratory operating without a valid license or whose license have 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 issuance of the law enforcement agency to enforce the closure of any clinical laboratory.

9.4 The closure order issued by the DOH shall not be rendered ineffective by any restraining order and injunction order issued by any court, tribunal or agency or instrumentalities.

SECTION 10. Modification and Revocation of License:

10.1 A license may be 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.

10.2 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 regulations shall supersede all 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 Gazette, or in a newspaper of general circulation.

Adopted: 19 Nov. 2001


Annex A

TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS

The Clinical Laboratory shall be organized to provide effective and efficient laboratory services.

I. STAFFING

1. 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.

2. The clinical laboratory shall employ qualified and adequately trained personnel. Work assignment shall be consistent with the qualification of the concerned personnel.

2.1 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 hospital-based clinical laboratory, there shall be at least one registered medical technologist per shift to cover the laboratory operation.

3. There shall be staff development and appropriate continuing education program available at all levels of organization to upgrade the knowledge, attitudes and skills of staff.

II. PHYSICAL FACILITIES

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.

3. There shall be an adequate water supply.

4. The working space for all categories of clinical laboratories (both hospital and non-hospital-based) shall have at least the following measurements:.

Category



Space in sq.m



Primary



10



Secondary



20



Tertiary (to include a separate,



60







enclosed and adequately







ventilated room for Microbiology)





III. EQUIPMENT/INSTRUMENTS:

1. There shall be provisions for sufficient number and types of appropriate equipment/instruments: in order to undertake all the activities and laboratory examinations. These equipment shall comply with safety requirements.

MINIMUM REQUIREMENTS FOR EQUIPMENT/INSTRUMENTS:

PRIMARY



SECONDARY



TERTIARY



CATEGORY



CATEGORY



CATEGORY















Clinical centrifuge



All those in Primary Category plus the following:



All those in Secondary Category plus the following:











Hemacytometer



Refrigerator



Incubator



Microhematocrit



Photometer or its equivalent



Balance, trip/analytical



centrifuge











Microscope w/ oil immersion objective



Water bath or its equivalent



Rotator















Hemoglobinometer or its equivalent



Timer or its equivalent



Serofuge or its equivalent















Differential blood cell











counter or its equivalent







Autoclave











Drying oven











Biosafety cabinet or its











equivalent



2. For other laboratory examinations being performed, the appropriate equipment necessary for performing such procedures shall be made available.

IV. GLASSWARES/REAGENTS/SUPPLIES

All categories of clinical laboratories shall provide adequate and appropriate glass wares, reagents and supplies necessary to undertake the required services.

V. WASTE MANAGEMENT

There shall be provisions for adequate and efficient disposal of waste following guidelines of the Department of Health and the local government. (copies of which are available at respective CHDs and DOH-BHFS and local government offices)

VI. QUALITY CONTROL PROGRAM

All clinical laboratories shall have a functional Quality Assurance Program.

1. Internal Quality Control Program

1.1 There shall be a documented, continuous competency assessment program for all laboratory personnel.

1.2 The program shall provide appropriate and standard laboratory methods, reagents & supplies and equipment.

1.3 There shall be a program for the proper maintenance and monitoring of all equipment.

1.4 The program shall provide for the use of quality control reference materials.

2. External Quality Control Program

2.1 All clinical laboratories shall participate in an External Quality Assurance Program given by designated National Reference Laboratories and/or other recognized reference laboratories.

2.2 A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of license.

2.3 Any refusal to participate in an External Quality Assurance Program given by the designated National Reference Laboratories shall be one of the basis for suspension/revocation of the license of the laboratory.

VII. REPORTING:

Laboratory requests shall be construed as consultation between the requesting physician and the pathologist of the laboratory and as such laboratory results shall be released accordingly.

1. All laboratory reports on various examinations of specimens shall bear the name of the registered medical technologist and the pathologist and duly signed 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.

VIII. RECORDING

There shall be a system of accurate recording to ensure quality results.

1. There shall be an adequate and effective system of recording requests and reports of all specimens submitted and examined.

2. There shall be provisions for filing, storage and accession of all reports.

3. All laboratory records shall be kept on file for at least one (1) year.

3.1 Records of anatomic and forensic pathology shall be kept permanently in the laboratory.

IX. 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 Technologist/s.

A notarized statement that the applicant has complied with all business requirements under existing laws or ordinances in the locally in the locality where the laboratory is located.

Location Map.

Floor Diagram.