Legal basis, relationship to prior issuances
- Republic Act No. 4688 regulates the operation and maintenance of clinical laboratories and requires registration with the Department of Health, and provides a penalty for violations.
- Administrative Order No. 59, s. 2001 (“Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines”) is revised through this Order.
- Provisions from previous issuances inconsistent or contrary to this Order are rescinded and modified accordingly (Repealing Clause).
- Provisions not affected by a judicial or competent authority declaration of invalidity remain valid and effective (Separability Clause).
Policy and objective
- The Order is anchored on regulation under FOURmula One (F1) for Health to ensure access to quality and affordable health products, devices, facilities, and services, especially for the poor.
- The Order requires regulatory enforcement to improve clinical laboratory performance mandated under Republic Act No. 4688.
- The Order prescribes revised minimum standards and technical requirements to ensure accuracy and precision of laboratory examinations for public health and safety.
- The Order aims to safeguard patient care quality because physicians rely on laboratory work-ups for prevention, diagnosis, and treatment.
Coverage and key definitions
- The Order applies to all individuals, agencies, partnerships, or corporations that operate clinical laboratories in the Philippines performing examinations and analysis of samples of tissues, fluids, secretions, excretions, or other materials from the human body yielding relevant laboratory information for disease prevention, diagnosis, treatment, and health management.
- Government clinical laboratories doing microscopy work only for specific DOH programs (including malaria screening, acid fast bacilli microscopy, tests for sexually transmitted infections, and cervical cancer screening using Pap smears) are exempt from the provisions of this Order.
- Applicant means a natural or juridical person who intends to operate a clinical laboratory.
- Clinical Laboratory means a facility where tests are performed on specimens from the human body to obtain information about a patient’s health status, covering disciplines that include (among others) clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, histopathology, cytology, toxicology, endocrinology, molecular biology, and cytogenetics, and providing consultative advisory services including interpretation of results and advice on further appropriate investigation; it also includes pre-analytical processes (collection, handling, preparation) and mailing/distribution centers in a laboratory network; total testing includes pre-analytical, analytical and post-analytical procedures.
- Critical Values are panic values originally described by Lundberg as life-threatening unless something is done promptly and corrective action can be undertaken.
- LTO (License to Operate) refers to the license.
- Mobile Clinical Laboratory is a laboratory unit that moves or has a temporary testing location, and it shall have a base laboratory.
- Monitoring Examinations are tests done in series on patients as a guide for treatment or follow-up.
- POCT (Point of Care Testing) is diagnostic testing at or near the site or patient care rather than in the clinical laboratory, including bedside testing, outpatient and home care.
- POL (Physician’s Office Laboratory) is a physician’s individual office/clinic where laboratory examinations are performed.
- Satellite Testing Site is any testing site performing laboratory examinations under the administrative control of a licensed laboratory, but outside the physical confines of that laboratory.
- STAT Tests are urgent cases with results released immediately, within one (1) hour after the procedure.
Classification and laboratory categories
- Clinical laboratories are classified by ownership as either:
- Government (operated and maintained wholly or partially by the national government, a local government unit, other political unit, or any department/division/board/agency), or
- Private (owned, established and operated by individuals, corporations, associations, or organizations).
- Clinical laboratories are classified by function into:
- Clinical Pathology (includes clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, endocrinology, molecular biology, cytogenetics, toxicology, therapeutic drug monitoring, and similar disciplines), and
- Anatomic Pathology (includes surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology, and molecular pathology).
- Clinical laboratories are classified by institutional character as:
- Institution Based (operates within premises and as part of an institution such as hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center), or
- Freestanding (does not form part of any other institution).
- Clinical laboratories are classified by service capability as:
- General Clinical Laboratory (with Primary, Secondary, and Tertiary categories, plus limited service capability for institution-based only), or
- Special Clinical Laboratory (highly specialized laboratory services usually not provided by a general clinical laboratory).
- A General Clinical Laboratory Primary Category provides at minimum: Routine Hematology (Complete Blood Count) (including specified components), Qualitative Platelet Determination, Routine Urinalysis, Routine Fecalysis, and Blood Typing for hospital based laboratories.
- A General Clinical Laboratory Secondary Category provides at minimum: the Primary Category capabilities plus Routine Clinical Chemistry (including specified substances), Quantitative Platelet Determination, Cross Matching for hospital based, Gram Staining for hospital based, and KOH for hospital based.
- A General Clinical Laboratory Tertiary Category provides at minimum: the Secondary Category capabilities plus Special Chemistry, Special Hematology including coagulation procedures, Immunology, and Microbiology – culture and sensitivity with aerobic and anaerobic capability differentiated by hospital based versus non-hospital based.
- A laboratory licensed under any general category may offer services other than the stipulated minimum services only if it complies with staff, equipment, reagents, and supplies requirements for the additional services and the additional services are listed under its LTO.
- Limited Service Capability is available for institution-based only and provides tests required for particular services in institutions such as dialysis centers and social hygiene clinics.
Licensing rules and operational standards
- The LTO is issued only to clinical laboratories that comply with minimum standards and technical requirements formulated by the BHFS.
- Clinical laboratories operated and maintained exclusively for research and teaching purposes are exempt from licensing, but must register with the BHFS.
- Special clinical laboratories not subject to other administrative orders (including Assisted Reproduction Technology Laboratories; Molecular and Cellular Technology; Molecular Biology; Molecular Pathology; Forensic Pathology; Anatomic Pathology laboratories independent of a clinical laboratory) must register with the BHFS without being licensed under this Order, and registration subsists until the appropriate regulation is promulgated; these laboratories must be headed by a pathologist or a licensed physician trained in management, principles, and methodology of the specialized services provided.
- The NRL designated by the DOH is covered by the license of the clinical laboratory of the hospital where it is assigned.
- An NRL physically independent from its hospital’s clinical laboratory may register only with the BHFS if duly accredited or certified by an international accrediting/certifying body (examples include CDC (U.S.A.) and WHO) and/or a local accrediting/certifying body recognized by the DOH.
- A POL must secure a clinical laboratory license if it:
- Issues official laboratory results; and/or
- Performs more than monitoring examinations; and/or
- Caters not only to the physician’s own patients.
- Examinations performed in a POL are permitted only when used for monitoring patients.
- A POCT conducted in a hospital must be under the management and supervision of the licensed clinical laboratory of the hospital.
- Every clinical laboratory must be organized to provide quality, effective and efficient laboratory services.
- Each clinical laboratory must be headed and managed by a pathologist certified as a Clinical Pathologist, an Anatomic Pathologist, or both by the Philippine Board of Pathology.
- The laboratory head must provide administrative and technical supervision, supervise staff in accordance with standards set by the Philippine Society of Pathologists, and ensure adequate medical technologists and other health professionals based on workload and services.
- Laboratories must maintain staff development and continuing education at all organizational levels.
- Laboratories must have operational equipment for licensed examinations, with a calibration, preventive maintenance, and repair program, plus a contingency plan for equipment breakdown.
- Laboratories must have required reagents, glassware, and supplies, with inventory control and storage under required conditions.
- Laboratories must implement written administrative policies and procedures, documented technical procedures, and quality systems including:
- An Internal Quality Assurance Program with an internal quality control program for technical procedures and an internal quality assurance program for inputs, processes and outputs, plus a continuous quality improvement program covering all aspects of laboratory performance.
- Participation in an EQAP administered by designated NRL or other local and international EQAP approved by the DOH.
- Laboratories must establish procedures for:
- Receipt and performance of routine and STAT requests;
- Reporting of routine and STAT results including critical values impacting patient care;
- Laboratory reports bearing the name and facsimile signature of accountable pathologists, and the name and signature of registered medical technologist(s) who performed the examinations; electronic signatures are permitted under the E-Commerce Law;
- Reporting workload, quality control, inventory control, work schedules and assignments;
- Reporting and analyzing incidents, adverse events, and handling complaints;
- Retention of laboratory records consistent with DOH or competent authority standards.
- Laboratories must conform to applicable local and national regulations for construction, renovation, maintenance and repair; maintain required space; ensure well-ventilated, lighted, clean, safe and functional areas; run a physical plant and facilities maintenance/monitoring program; implement procedures for proper disposal of waste and hazardous substances; and adopt biosafety and biosecurity policy guidelines.
- When laboratory examinations are referred to an outside laboratory, the referring laboratory head must obtain assurance of service quality through a Memorandum of Agreement or equivalent with a licensed clinical laboratory performing the needed tests.
LTO requirements, duration, display, and change reporting
- The LTO is issued in the name of the licensee and is non-transferable whether voluntarily or involuntarily, including through sale, assignment, or any other means.
- The LTO is valid only for the premise/location stipulated in the license and is not valid for other premises/locations.
- For a clinical laboratory, the LTO remains valid for one year and expires on the date stated on the face of the license as set by the CHD, unless suspended or revoked sooner.
- For a non-hospital based clinical laboratory, the LTO must specifically stipulate the: name of the clinical laboratory, owner/operator name(s), head of laboratory, service capability, period of validity, license number, and location where laboratory procedures are performed.
- A non-hospital based clinical laboratory must display the LTO at all times in a prominent place within the laboratory premises.
- Hospital based clinical laboratories must be licensed as part of the hospital through the One-Stop-Shop Licensure for Hospitals and do not require a separate license.
- The capability to perform HIV testing and/or drinking water analysis must be specifically indicated in the LTO issued by the CHD.
- The clinical laboratory and its satellite services within the same compound must have one (1) LTO.
- A satellite laboratory outside the premises of the central laboratory must secure a separate LTO.
- A mobile clinical laboratory must be licensed as part of the main clinical laboratory and may collect specimens only.
- A mobile clinical laboratory may operate only within a radius of one hundred (100) km from its main laboratory.
- Substantial changes affecting conditions of a clinical laboratory set forth in its LTO must be reported to the concerned CHD within two (2) weeks from the initial date of implementation through a written, signed report by the licensee for notation.
- The LTO may be revoked, suspended, or modified in full or in part for any material false statement by the applicant, for findings shown by inspection records, or for violation of, or failure to comply with, any terms and conditions and provisions of the rules.
Application, renewal, inspection, and monitoring
- Registration for special clinical laboratories, NRLs, and research/teaching laboratories uses a prescribed application form obtained from the BHFS, CHD with jurisdiction, or the DOH website (doh.gov.ph).
- Registration application submissions include the accomplished form and necessary attachments submitted to the BHFS or through the CHD with jurisdiction over the existing or proposed laboratory.
- Registration requires payment of a non-refundable application fee for a Certificate of Registration upon submission of the accomplished form and documentary requirements.
- The BHFS evaluates and accepts applications based on proper execution of forms and completeness of attachments.
- For initial and renewal LTO applications:
- The prescribed LTO application form is obtained from the BHFS, CHD with jurisdiction, or doh.gov.ph.
- Completed forms with attachments must be submitted to the CHD with jurisdiction over the existing or proposed clinical laboratory.
- An LTO requires payment of a non-refundable application fee upon submission.
- The CHD with jurisdiction conducts inspections consistent with licensing requirements, including under the One-Stop-Shop Licensure System for Hospitals.
- Renewal rules:
- Hospital based clinical laboratories renew through the One-Stop-Shop Licensure System for Hospitals.
- Non-hospital based clinical laboratories must file renewal applications beginning the first day of October until the last day of November of the current year.
- A discount on the renewal fee is granted when a complete application is filed during the October 1 to November last period.
- Renewal of license for compliant clinical laboratories is processed not later than five (5) working days after the expiration date of the license.
- The LTO of a clinical laboratory is automatically cancelled without notice when the laboratory fails to submit a duly accomplished application form and pay the proper fee on or before the license’s expiration date.
- Inspection and access:
- The CHD conducts announced licensure inspections at any reasonable time.
- The licensee must ensure accessibility of premises and facilities and availability of all pertinent records for review by the CHD Director or authorized representatives at any reasonable time.
- An inspection tool with standards, criteria, and technical requirements for LTO issuance is utilized.
- Monitoring:
- Clinical laboratories are monitored regularly.
- The BHFS or the CHD Director (or authorized representatives) performs monitoring visits at any reasonable time.
- Laboratories must make records, premises, and facilities available for compliance determination.
- A Notice of Violation for non-compliant clinical laboratories is issued immediately after monitoring.
- The CHD concerned must submit a quarterly summary of violations to the BHFS stating the laboratory name, location, the corresponding violation, and the course of action taken.
- Provincial, City and Municipal Health Officers must report to the BHFS/CHD the existence of unlicensed clinical laboratories or private parties performing laboratory examinations without proper license and/or violating these rules.
Fees and payment rules
- A non-refundable fee is charged for the initial application and renewal of a license to operate a clinical laboratory, whether government or private.
- Fees/checks must be paid to the order of DOH in person or through postal money order.
- All fees, surcharges, and discounts follow the current DOH prescribed schedule of fees.
Prohibited acts, sanctions, investigation, and appeal
- Violations subject to penalty include violation of Republic Act 4688 and/or this Order, including the following acts by personnel operating the clinical laboratory under authority:
- Refusal to participate in an EQAP conducted by the designated NRL or other external proficiency program approved by the DOH.
- Issuance of reports orally or in writing, in whole or portions, not in accordance with documented procedures approved by the head of the laboratory.
- Permitting unauthorized persons to perform technical procedures.
- Demonstrating incompetence or making consistent errors in performing clinical laboratory examinations and procedures.
- Deviating from standard test procedures including using expired reagents.
- Reporting/releasing erroneous results.
- Lending or using the name of the licensed clinical laboratory, the head of the laboratory, or medical technologist(s) to an unlicensed clinical laboratory.
- Unauthorized use of the name and signature of the pathologist and medical technologist to secure LTO.
- Reporting a test result for a clinical specimen even if the test was not actually performed.
- Transferring results of tests done in an outside clinical laboratory to the referring laboratory’s result form.
- Performing and reporting tests in a specialty or subspecialty in which the laboratory is not licensed.
- Giving and receiving any commission, bonus, kickback, or rebate or engaging in any split-fee arrangement directly or indirectly with any facility, physician, organization, agency, or person for patients referred to a DOH-licensed clinical laboratory.
- Complaint investigation:
- The BHFS or the CHD Director (or authorized representatives) investigates complaints and verifies accountability for alleged violations.
- After investigation, the CHD Director (or authorized representatives) suspends, cancels, or revokes the LTO for a determined period for licensees found violating Republic Act 4688 or this Order.
- The CHD may take steps to seek assistance of law enforcement to execute closure of an erring clinical laboratory when necessary.
- Sanctions under this process do not prejudice taking the case to judicial authority for criminal action.
- Criminal penalty for operating without proper license:
- Any person who operates a clinical laboratory without the proper license from DOH upon conviction is subject to imprisonment for not less than one (1) month or a fine of not less than PHP 1,000.00 and not more than PHP 5,000.00, or both, at the discretion of the court.
- If the offender is a firm or corporation, the managing head and/or the owner(s) are liable to the penalty imposed.
- Appeal:
- Decisions of the BHFS/CHD may be appealed to the Office of the Health Secretary within ten (10) days after receipt of the notice of the decision.
- The BHFS must promptly certify and file with the Office of the Health Secretary a copy of the decision, including all documents and transcript of hearings on which the decision is based.
- The decision of the Office of the Health Secretary is final and executory.