Clinical Lab Regulations, DOH AO No. 59, 2001

Legal basis and policy intent

Administrative Order No. 59, s. 2001 is 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 purpose is to protect and promote the health of the people by ensuring that clinical laboratories are available and properly managed.
Compliance is required to achieve effective and efficient laboratory performance through adherence to quality standards.
The regulatory framework centers on licensing, inspection, and enforcement to ensure safe and quality laboratory services.

Coverage and applicable clinical laboratories

These regulations apply to all entities that perform activities and functions of clinical laboratories.
A clinical laboratory is covered when it examines and analyzes samples of human and other related tissues, fluids, secretions, excretions, radioactive, or other materials from the human body to determine the existence of pathogenic organisms, pathologic processes, or conditions.
The regulations govern laboratories performing the above determinations for the person from whom samples are obtained.
The regulations do not include government laboratories doing laboratory examinations limited to acid fast bacilli microscopy, malaria screening, and cervical cancer screening when their services are declared as extension of a licensed government clinical laboratory.

Laboratory classifications

Clinical laboratories are classified by function, including Clinical Pathology and Anatomic Pathology.
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.
Anatomic Pathology includes: Surgical Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology.
Laboratories are classified by institutional character as either hospital-based (operates within a hospital) or non-hospital-based (operates on its own).
Laboratories are classified by service capability as Primary, Secondary, and Tertiary, with defined minimum capabilities for each:
- Primary includes Routine Hematology (Complete Blood Count or CBC) with specified components; Routine Urinalysis; Routine Fecalysis; Blood Typing (hospital-based); and Quantitative platelet determination (hospital-based).
- Secondary provides the minimum primary capabilities and adds Routine Clinical Chemistry with specified analytes and Cross matching (hospital-based).
- Tertiary provides the secondary capabilities and adds Special Chemistry, Special Hematology, Immunology/Serology, and Microbiology.

Core compliance policies

A clinical laboratory must secure an approved permit to construct and design lay-out from BHFS before submitting an application for a petition to operate.
No clinical laboratory may be constructed unless plans have been approved and a construction permit has been issued by BHFS.
A clinical laboratory must operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements (Annex A).
A clinical laboratory must be organized and managed to provide effective and efficient laboratory services.
A clinical laboratory must provide adequate and appropriate safety practices for its personnel and clientele.

Permits, petitions, licenses, and fees

Application for a Permit to Construct requires:
- A Letter of Application to the Director of BHFS; and
- Four (4) sets of Site Development Plans and Floor Plans approved by an architect and/or engineer; and
- DTI/SEC Registration (for private clinical laboratory).
Application for a New License must be filed by the owner or a duly authorized representative at BHFS using a duly notarized application-form “Petition to Establish, Operate and Maintain a Clinical Laboratory” (Annex C).
Application for Renewal of License must be filed by the owner or a duly authorized representative at the respective CHD using a duly notarized application-form “Application for Renewal of License to Establish, Operate and Maintain A Clinical Laboratory” (Annex C).
Renewal applications must be filed within 90 days before the expiry date of the license, with region-based filing schedules:
- 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
Fees and payments are governed as follows:
- A non-refundable license fee is charged for applications for permit to construct and for license to operate for both government and private clinical laboratories.
- A non-refundable fee is charged for applications for renewal to operate.
- All fees must be paid to the cashier of BHFS/CHD.
- Fees must follow the current prescribed schedules of fees of the DOH.

Penalties and enforcement mechanisms

Late renewal penalties apply as follows for all categories:
- A P1,000.00 penalty for late renewal is charged in addition to the renewal fee if filed during the next two (2) months after expiry date.
- An application received more than two (2) months after expiry date is fined P100.00 for each month thereafter in addition to the P1,000.00 penalty.
For inspection, each licensee must:
- Make premises and facilities available to the Director of the BHFS/CHD (or authorized representative) at any reasonable time for inspection;
- Make all pertinent records available to the Director (or authorized representative);
- Allow inspection of clinical laboratories every two (2) years or as necessary.
For monitoring, the Director (or authorized representative) must be allowed to monitor the clinical laboratory at any given time and the laboratory must make records available for monitoring.
License issuance and license status rules:
- A license is issued by the Director of the CHD (or authorized representative) if the application is found meritorious.
- The license is non-transferable.
- Relocating a licensed laboratory requires written notice to the CHD at least 15 days before actual transfer, and the new location must undergo reinspection and comply with licensing requirements.
- An extension laboratory must have a separate license.
- Any change affecting substantial conditions of the license must be reported within 15 days in writing to BHFS/CHD for notation and approval; failure to do so causes revocation of the license.
- The clinical laboratory license must be placed in a conspicuous location/area within the laboratory.

Violations, suspensions, and criminal sanctions

The Secretary of Health may suspend or revoke the license to operate a clinical laboratory upon violation of R.A. 4688 or these rules and regulations.
The following acts are considered violations committed by the Owner, President, Managers, Board of Trustees/Director, Pathologist, or its personnel:
- Operating without a certified pathologist or without a registered medical technologist.
- Changing ownership, location, head of laboratory, or personnel without informing BHFS and/or CHD.
- Refusing to allow inspection by authorized persons of BHFS during reasonable hours.
- Gross negligence.
- Any act or omission detrimental to the public.
Provincial, City, and Municipal Health Officers are authorized to report to CHD and BHFS the existence of unlicensed clinical laboratories or private parties performing laboratory examinations without proper license and/or violating the rules.
Complaint/investigation procedure:
- BHFS/CHD or authorized representative(s) must investigate complaints and verify whether the laboratory or personnel are guilty of the charged violations.
- If a person violates R.A. 4688 or these rules, BHFS/CHD or authorized representative(s) may suspend, cancel, or revoke the license and the authority of the offending person(s) for a determined period of time, without prejudice to criminal action in judicial authority.
Criminal liability for unlicensed operation:
- Any person who operates a clinical laboratory without proper license and is convicted is subject to imprisonment of 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.
- If the offender is a firm or corporation, the Managing Head and/or owner/s are liable to the imposed penalty.
Closure and injunction rule:
- Laboratories operating without a valid license or whose license has been revoked/cancelled are subject to summary closure by order issued by BHFS/CHD or authorized representative(s).
- BHFS/CHD may seek law enforcement agency action to enforce closure.
- A DOH closure order is not rendered ineffective by any restraining order and injunction issued by any court, tribunal, or agency or instrumentalities.

License modification, notice, and procedure

A license may be revoked, suspended, or modified in whole or in part for any material false statement by the applicant, or based on inspection records, or for violations or failure to comply with terms and conditions and provisions of the rules.
No license may be modified, suspended, or revoked unless prior notice is given and a corresponding investigation is conducted.
Prior notice and investigation may be dispensed with in cases of willful or repeated violations, or where public health interest or safety requires otherwise.

Annex A: Technical standards and minimum requirements

Staffing standards require:
- Management by a licensed physician certified by the Philippine Board of Pathology.
- In areas where pathologists are not available, management of primary/secondary category laboratories by a physician with three (3) months training in clinical laboratory medicine, quality control, and laboratory management, with BHFS certification of such training.
- Qualified and adequately trained personnel with work assignments consistent with qualifications.
- Sufficient registered medical technologists proportional to workload and available at all times during operating hours.
- For hospital-based laboratories, at least one registered medical technologist per shift to cover laboratory operations.
- Staff development and continuing education programs at all levels.
Physical facilities minimum requirements require:
- Well-ventilated, adequately lighted, clean and safe facilities.
- Working space sufficient for activities and smooth work flow.
- Adequate water supply.
- Minimum floor area by category:
  - Primary: 10 sq.m
  - Secondary: 20 sq.m
  - Tertiary: 60 sq.m, including a separate, enclosed and adequately ventilated room for Microbiology.
Equipment/instruments minimum requirements require:
- Sufficient number and types of appropriate equipment to undertake all activities and examinations, and equipment must comply with safety requirements.
- Minimum equipment lists by category:
  - Primary: clinical centrifuge; hemacytometer; refrigerator; incubator; microhematocrit; photometer or its equivalent; balance (trip/analytical centrifuge); microscope w/ oil immersion objective; water bath or its equivalent; timer or its equivalent; serofuge or its equivalent; differential blood cell counter or its equivalent; hemoglobinometer or its equivalent; autoclave; drying oven; biosafety cabinet or its equivalent; and rotator.
  - Secondary: all those in Primary plus: (as listed) refrigerator, incubator, autoclave, and other items under the combined minimum list for Primary are carried forward as “all those in Primary Category plus the following” and includes the additional secondary items shown (including items explicitly listed under Secondary).
  - Tertiary: all those in Secondary plus: (as listed) additional equipment necessary for tertiary capabilities, including microbiology support equipment indicated by the tertiary room requirement.
- For other examinations performed, appropriate equipment for those procedures must be available.
Glassware, reagents, and supplies must be adequate and appropriate for all required services in all categories.
Waste management requires adequate and efficient disposal following DOH and local government guidelines, with copies available at respective CHDs, DOH-BHFS, and local government offices.
Quality control program requires:
- A functional Quality Assurance Program for all clinical laboratories.
- Internal Quality Control Program requiring documented continuous competency assessment, standardized methods/reagents/supplies/equipment maintenance and monitoring, and use of quality control reference materials.
- External Quality Control Program participation in an External Quality Assurance Program given by designated National Reference Laboratories and/or other recognized reference laboratories.
- A satisfactory performance rating from a National Reference Laboratory as a criterion for renewal of license.
- Refusal to participate in the external quality assurance program as a basis for suspension/revocation of the license of the laboratory.
Reporting requirements require:
- Laboratory requests to be treated as consultation between requesting physician and pathologist, and results released accordingly.
- Laboratory reports to bear the name of the registered medical technologist and the pathologist and must be signed by both.
- No report issuance by any person in the laboratory—oral or written, whole or portions—without directive from the pathologist or authorized associate to the requesting physician or authorized representative, except in emergency cases when results may be released as authorized by the pathologist.
Recording requirements require:
- Accurate recording system ensuring quality results.
- Adequate system for recording requests and reports of all specimens submitted and examined.
- Filing, storage, and accession provisions for all reports.
- Keeping all laboratory records on file for at least one (1) year.
- Keeping records of anatomic and forensic pathology permanently in the laboratory.
Laboratory fees require:
- Charging laboratory and professional fees at prevailing rates.
- Ensuring rates fall within the usual fees prevailing at the time and place, taking into consideration the cost of testing and quality control of procedures.
- Charging professional services rendered to the patient for special procedures or examinations separately and not included in laboratory fees.

Registration/operation document requirements for private

Private laboratories must obtain a Certificate of Registration of Business Name from the Department of Trade and Industry, and a certificate from the Security and Exchange Commission if the laboratory is a corporation.
Private laboratories must obtain certificates from the Philippine Board of Pathology.
Private laboratories must obtain PRC board certificates of Medical Technologist/s.
Private laboratories must submit 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.
Private laboratories must submit a Location Map and Floor Diagram.

Publication and list of licensed laboratories

A list of licensed clinical laboratories must be published annually in a newspaper of general circulation.