Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2008-0007)
The purpose of DOH Administrative Order No. 2008-0007 is to prescribe the schedule of fees for services rendered by the Centers for Health Development (CHDs) related to the regulation of clinical laboratories, specifically the License to Operate (LTO) fees for general clinical laboratories and the registration fee for special clinical laboratories.
Clinical laboratories are classified into two main categories: general clinical laboratories and special clinical laboratories. General clinical laboratories are further categorized into primary, secondary, tertiary, and limited service capability (institution-based only).
Licensing of clinical laboratories has been decentralized to the Centers for Health Development (CHDs), which conduct initial licensure and renewal processes, leading to expected cost savings and lower LTO fees for non-hospital-based clinical laboratories.
The LTO fee for a hospital-based general clinical laboratory with limited service capability is the same as that for a general clinical laboratory of primary category and is incorporated into the hospital License to Operate fee.
Non-hospital-based general clinical laboratories have a lower fee structure due to decentralized licensing. For example, the LTO fees for limited service capability and primary category laboratories range from PHP 1,500 to PHP 2,500 for initial fees from 2008 to 2010, with corresponding renewal fees lower than hospital-based counterparts.
The registration fee for special clinical laboratories is PHP 200, the same fee as for other health facilities such as new hospitals and dental laboratories.
CHDs may charge an additional fee of up to 20% of the prescribed fee based on actual costs incurred for the service.
If additional inspections are required before issuing the License to Operate, a re-inspection fee equal to 100% of the original LTO fee will be charged for each re-inspection. This applies to both initial and renewal LTO applications.
Yes, a 10% discount on the renewal fee is granted if the complete renewal application is filed between October 1 and November 30 of the current year.
Applicants must pay the corresponding fees to the CHD cashier in person or via postal money order upon filing their application.
The separability clause provides that if any provision or part of this Order is declared invalid or unauthorized, the remaining provisions not affected will remain valid and effective.
This Order took effect fifteen (15) days after its approval and publication in the Official Gazette or a newspaper of general circulation, following its adoption on March 14, 2008.