QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2007-0027)
DOH Administrative Order No. 2007-0027 is issued to revise the minimum standards and technical requirements for the licensure and regulation of clinical laboratories in the Philippines, to improve accuracy of laboratory results and safeguard public health. It is anchored on the mandate of Republic Act No. 4688 (which requires DOH oversight of clinical laboratories for public welfare), and it updates earlier DOH regulatory issuances that may no longer be relevant.
It applies to individuals, agencies, partnerships, or corporations that operate clinical laboratories in the Philippines performing tests on human specimens to yield information used for prevention, diagnosis, and treatment. Government clinical laboratories that do microscopy work only for specific DOH programs (e.g., malaria screening, AFB microscopy, certain STI tests, and cervical cancer screening via Pap smears) are exempt.
A clinical laboratory is a facility where tests are done on human specimens to obtain relevant information about a patient’s health status, used for prevention, diagnosis, and treatment. It includes multiple disciplines (e.g., chemistry, hematology, microbiology, histopathology, cytology, toxicology, immunology, molecular biology, cytogenetics). It also includes consultative advisory services and facilities involved in pre-analytical processes (collection/handling/preparation) and mailing/distribution centers in lab networks. The “total testing process” includes pre-analytical, analytical, and post-analytical procedures.
The LTO is the license issued by DOH (through the CHD) to a laboratory operator upon compliance with the requirements. It is non-transferable whether voluntarily or involuntarily (e.g., through sale/assignment). It is not valid for any premise/location other than that stipulated in the LTO. The license is generally valid for one year and expires on the date stated by the CHD.
They are classified: (1) by ownership—government or private; (2) by function—clinical pathology or anatomic pathology; (3) by institutional character—institution-based or freestanding; and (4) by service capability—general clinical laboratory (primary/secondary/tertiary), limited service capability (institution-based only), or special clinical laboratory.
A primary category general clinical laboratory must provide: (i) Routine Hematology (including Hb concentration, hematocrit, WBC count, and differential count), (ii) Qualitative platelet determination, (iii) Routine urinalysis, (iv) Routine fecalysis, and (v) Blood typing for hospital-based laboratories.
A secondary category laboratory provides the primary capabilities plus: Routine clinical chemistry (glucose, BUN, uric acid, creatinine, total cholesterol), quantitative platelet determination, cross-matching for hospital-based labs, Gram staining for hospital-based labs, and KOH for hospital-based labs. A tertiary category provides the secondary capabilities plus: special chemistry, special hematology including coagulation procedures, immunology, and microbiology (culture and sensitivity) with aerobic/anaerobic options depending on whether hospital-based or non-hospital based.
Yes. A laboratory licensed under any category may offer additional services other than the minimum stipulated ones, provided it complies with staff, equipment, reagent, and supply requirements for such additional services and that the additional services are listed under its LTO.
A POL must secure a clinical laboratory license if it: (a) issues official laboratory results; (b) performs more than monitoring examinations; and/or (c) caters not only to the physician’s own patients. Examinations in a POL are permitted only when used for monitoring patients.
A POCT conducted in a hospital is required to be under the management and supervision of the licensed clinical laboratory of the respective hospital.
Every clinical laboratory must be headed and managed by a pathologist certified either as a Clinical Pathologist, an Anatomic Pathologist, or both by the Philippine Board of Pathology. The head must provide administrative and technical supervision of lab activities and supervise staff in line with standards set by the Philippine Society of Pathologists.
Each laboratory must have an Internal Quality Assurance Program including: (i) an Internal Quality Control Program for technical procedures, (ii) an Internal Quality Assurance Program for inputs, processes, and outputs, and (iii) a Continuous Quality Improvement Program covering all aspects of laboratory performance. It must also participate in an EQAP administered by designated NRLs or other local/international EQAPs approved by DOH.
The lab must have procedures for the receipt and performance of routine and STAT requests; procedures for reporting results (including critical values that impact patient care); and lab reports must bear the name and facsimile signature of the accountable pathologist and the name/signature of the registered medical technologist(s) who performed the tests. Electronic signatures are allowed per the E-Commerce Law.
Satellites within the same compound generally share one LTO for the clinical laboratory and satellite services. A satellite laboratory outside the physical premises where the central laboratory is situated must secure a separate LTO. Mobile clinical laboratories are licensed as part of the main clinical laboratory and may collect specimens only, operating only within a 100 km radius from the main laboratory.
The laboratory must report such changes to the concerned CHD within two (2) weeks from the initial date of implementation. The report must be in writing, signed by the licensee, and submitted for notation.
Examples include: refusal to participate in EQAP; issuing reports not in accordance with documented procedures; permitting unauthorized persons to perform technical procedures; consistent errors/incompetence; deviation from standard test procedures (including use of expired reagents); reporting erroneous results; lending/using a licensed laboratory’s name to an unlicensed lab; unauthorized use of pathologist/technologist names to secure LTO; reporting tests not actually performed; performing tests in specialties/subspecialties not covered by the license; and engaging in kickbacks/split-fee arrangements with facilities or physicians for patient referrals.
Any person who operates a clinical laboratory without the proper DOH license, upon conviction, may be punished by imprisonment of not less than one (1) month or a fine of not less than PHP 1,000 and not more than PHP 5,000, or both, at the court’s discretion. If the offender is a firm or corporation, the managing head and/or owner(s) may be liable.