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By virtue of Administrative Order No. 2007-0027 Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines, the classification of clinical laboratories was revised. Laboratories are now classified according to service capability as general clinical laboratories or special clinical laboratories. The former is further classified into the following primary category, secondary category, tertiary cat-90ry, and limited service capability (for institution-based only)

Another important provision of A.O. No. 2007-0027 is the decentralization of the licensing process for clinical laboratories to the Centers for Health Development (CHDs) both for initial licensure and the renewal of license. Since licensing is now performed by the CHDs, there would be an expected decrease in the cost of regulation, which should be reflected in a decrease in the license to Operate (LTO) fees, particularly for non-hospital based clinical laboratories.

In view of the above, the schedule of fees related to the regulation of clinical laborato ries has to be revised in order to address the LTO fee or registration fee for the two new categories of clinical laboratories, namely the special clinical laboratory as well as the general clinical laboratory with limited service capability, taking into account the changes in the licensing process for clinical laboratories.

II. OBJECTIVE
This Administrative Order prescribes the schedule of fees for certain services rendered by the CHDs in relation to the regulation of clinical laboratories, particularly the LTO fees for general clinical laboratories and the registration fee for special clinical laboratories.

III. FEES, SURCHARGES AND DISCOUNTS
A. Schedule of Fees

The CHDs shall prescribe the following fees for their services related to the regulation of clinical laboratories.

1. Hospital-Based General Clinical Laboratory

The LTO fee for a hospital-based general clinical laboratory with limited service capability shall be the same as the current LTO fee for the general clinical laboratory of primary category. It shall be incorporated into the hospital LTO fee.

The LTO fee for hospital-based general clinical laboratory of primary, secondary and tertiary categories shall follow the current schedule of fees prescribed under Administrative Order No. 2007-0023 Schedule of Fees for the One-Stop Shop Licensure System for Hospitals.

LTO Free	Initial (PHP)			Renewal (PHP)
	2008	2009	2010	2008	2009	2010
Clinical Laboratory
-Limited Service Capability	1,200	1,600	2,000	---	1,200	1,500
-Primary	1,200	1,600	2,000	---	1,200	1,500
-Secondary	1,500	2,000	2,500	---	1,600	2,000
-Tertiary	2,000	2,700	3,000	---	2,300	2,500

2 Non-Hospital-Based General Clinical Laboratory

The following is the new schedule of fees for non-hospital-based general Clinical laboratories. Because of the decentralization of the licensing process for clinical laboratories to the CHDs, the LTO fees for these health facilities are set lower than those prescribed under A.O. 2007-0001.

The LTO fee for a non-hospital based general clinical laboratory with limited service capability shall be the same as the prescribed LTO fee for the general clinical laboratory primary category.

LTO Free	Initial (PHP)			Renewal (PHP)
	2008	2009	2010	2008	2009	2010
Clinical Laboratory
-Limited Service Capability	1,500	2,000	2,500	1,000	1,500	2,000
-Primary	1,500	2,000	2,500	1,000	1,500	2,000
-Secondary	2,000	2,500	3,000	1,500	2,000	2,500
-Tertiary	2,500	3,000	3,500	2,000	2,500	3,000

3 special Clinical Laboratory

The registration fee for special clinical laboratories shall be the same as existing registration fee for other health facilities such as new hospitals, psychiatric care facilities and dental laboratories

Registration Fee (in PHP)
Special Clinical Laboratory 200

B. Other Fees, Surcharges, Discounts and Payment of Fees

For hospital-based clinical laboratories, guidelines on additional fees to be charged by the CHD, re-inspection fee, surcharge, discount on the renewal fee and payment of fees shall follow the relevant provisions of Administrative Order No. 2007-0023 Schedule of Fees for the One-Stop Shop Licensure System for Hospitals.

For non-hospital-based clinical laboratories, the following are the guidelines on other fees and discounts, and payment of fees, which are based on the relevant provisions of Administrative Order No. 2007-0027 Revised Rules and Regulations Governing the Licensure and Regulations of Clinical Laboratories in the Philippines, as well as the relevant provisions of Administrative Order No. 2007-0001 Revised Schedule of Fees for Certain Services Rendered by the Bureau of Health Facilities and Services and Centers for Health Development in Relation to the Regulation of Health Facilities and Services and Validity Period of License to Operate, Accreditation, Authority to Operate, and Clearance to Operate for Certain Health Facilities and Services.

1 Additional Fee to be Charged by the CHD

The CHDs may charge an additional fee of not more than twenty percent (20%) of the Prescribed fee, depending on the actual costs incurred by the concerned CHD in the Provision of the service.

2 Re-inspection Fee

If additional site visits or inspections are needed before the LTO can be granted, a re-inspection fee that is equal to one hundred percent (100%) of the LTO fee shall be charged 0 the applicant for each re-inspection conducted by the CHD, over and above the initial LTO fee.

The re-inspection fee shall be applicable to both initial LTO and renewal of LTO

3. Discount on Renewal Fee

A ten percent (10%) discount on the renewal fee shall be granted if a complete application for renewal is filed during the period beginning on the first day of October until the last day of November of the current year.

4. Payment of Fees

The applicant, upon filing an application, shall pay the corresponding fee to the CHD Cashier in person or through postal money order.

IV. SEPARABILITY CLAUSE
In the event that any provision or part of this Order be declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected by such declaration shall remain valid and effective.

V. REPEALING CLAUSE
This Order shall repeal or supersede all administrative orders and previous issuances inconsistent thereof.

VI. EFFECTIVITY
This Order shall take effect fifteen days (15) upon approval and publication in the official gazette or newspaper of general circulation.

Adopted: 14 March 2008

(SGD.) FRANCISCO T. DUQUE III, MD, MSc.
Secretary of Health