Question & AnswerQ&A (ADMINISTRATIVE ORDER NO. 59, S. 2001, NOVEMBER 19, 2001)
The Administrative Order is titled "Rules and Regulations Governing the Establishment, Operation and Maintenance Of Clinical Laboratories in the Philippines."
The purpose is to protect and promote public health by ensuring clinical laboratories are properly managed, adequately resourced, and comply with quality standards.
They apply to all entities performing clinical laboratory activities including examination and analysis of human tissues, fluids, and related materials for detecting pathogenic organisms or pathological conditions.
No, government laboratories limited to such tests are exempt if their services are considered extensions of a licensed government clinical laboratory.
By function (Clinical Pathology and Anatomic Pathology), by institutional character (Hospital-based and Non-hospital-based), and by service capability (Primary, Secondary, and Tertiary).
Routine Hematology, Urinalysis, Fecalysis, Blood Typing (hospital-based), and Quantitative Platelet Determination (hospital-based).
An approved permit to construct and layout design must be secured from BHFS prior to applying for a Petition to Operate, and operation requires a valid license issued by BHFS/CHD.
Operators may be imprisoned from 1 month to 1 year, fined between P1,000 to P5,000, or both. For firms or corporations, managing heads/owners are liable.
Operating without a certified pathologist or registered medical technologist; changing ownership or location without informing BHFS/CHD; refusal to allow authorized inspection; gross negligence; and acts detrimental to the public.
Must be managed by a licensed physician certified by the Philippine Board of Pathology or a physician with specified training; sufficient registered medical technologists must be present proportional to workload, with at least one per shift in hospital-based labs.
Every two years or as necessary.
A notarized application must be filed within 90 days before expiry, with specific regional schedules, and renewal fees must be paid. Late renewals incur penalties.
No, the license is non-transferable. Transfer or relocation requires written notice to CHD at least 15 days prior and compliance with reinspection and licensing requirements.