Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2007-0027)
The main objective is to prescribe revised minimum standards for clinical laboratories in the Philippines to ensure accuracy and precision of laboratory examinations in order to safeguard public health and safety.
It applies to all individuals, agencies, partnerships, or corporations that operate clinical laboratories in the Philippines performing examinations and analyses of human body specimens for diagnosis, prevention, and treatment of diseases and public health management.
Yes, government clinical laboratories doing microscopy only for specific DOH programs like malaria screening, acid-fast bacilli microscopy, tests for sexually transmitted infections, and cervical cancer screening using Pap smears are exempted from the provisions of this Order.
A clinical laboratory is a facility where tests are done on human specimens to obtain health information for prevention, diagnosis, and treatment of diseases, including various disciplines such as clinical chemistry, hematology, microbiology, pathology, and others, covering pre-analytical to post-analytical procedures.
Every clinical laboratory shall be headed and managed by a pathologist certified by the Philippine Board of Pathology as a Clinical Pathologist, Anatomic Pathologist, or both.
The LTO is a document issued by the Department of Health allowing an individual, agency, partnership, or corporation to operate a clinical laboratory upon compliance with prescribed requirements. It is non-transferable and specific to the licensed premises.
Any person operating without a proper license shall, upon conviction, be subject to imprisonment for not less than one month or a fine of not less than Php 1,000.00 but not more than Php 5,000.00 or both, at the court's discretion. If the offender is a firm or corporation, owners and managing heads are liable.
EQAP is a program where laboratories are given unknown samples to analyze, helping assess the quality of laboratory performance by comparing results to reference or peer group values. Participation in EQAP is mandatory for licensed clinical laboratories.
Changes must be reported in writing, signed by the licensee, to the concerned Center for Health Development within two weeks from the date of implementation for notation.
Violations include refusal to participate in EQAP, issuing reports not in accordance with protocols, permitting unauthorized persons to perform procedures, making consistent errors, using expired reagents, releasing erroneous results, unauthorized use of names and signatures, and engaging in illegal commission or rebate schemes.