QuestionsQuestions (KPL BUREAU ORDER NO. 6)
It is issued to implement R.A. 4688 (Clinical Laboratory Law) with its Revised Rules and Regulations (A.O. #49-B, s. 1988) and R.A. #1517 (Blood Bank Law) with its Revised Rules and Regulations (A.O. #57, s. 1989), consistent with E.O. 119 (reorganization of the Ministry of Health).
To facilitate the application and licensing of clinical laboratories and blood banks in accordance with the cited laws and their implementing rules and regulations.
Forms may be secured in person or requested by mail from the Licensure Section, Division of Laboratory Regulation and Development, Bureau of Research and Laboratories (BRL), San Lazaro Compound, Sta. Cruz, Manila, or from the Regional Health Office where the clinical laboratory/blood bank is located.
New application: BRL/CL/BB Forms Nos. 1, 2, 3. Renewal application: BRL/CL/BB Forms Nos. 2 & 3.
The order requires: (1) Xerox copy of proficiency certificate of the pathologist or head of the CL/BB; (2) Xerox copy of current hospital license (except new hospitals not yet licensed); (3) Xerox copy of Certificate of Registration of Business Name from the Bureau of Domestic Trade; and (4) Notarized certification of compliance with other business requirements.
It may be filed either in person or by mail to the BRL through its Licensure Section (DLRD).
The fee (usually cash or postal money order) is paid to the BRL cashier using a charge slip issued by the Licensure Section. Penalties and other charges, if any, are paid at the same time.
The application must be mailed with the license fee in a postal money order payable to the BRL. Upon receipt at the Licensure Section, a charge slip is issued and the PMO is paid to the cashier.
The applicant files in duplicate with the Regional Licensing Unit of the Regional Health Office; pays fees through a PMO to BRL; forwards to BRL (before PMO expires) the PMO and notice/date of receipt plus one copy of the application and documents; pays PMO to the cashier via a charge slip; and receives acknowledgment letter with OR enclosed.
It states that only completed and supported applications are processed.
It is assigned a number and filed in an individual folder; recorded in the In-Coming Record Book; and an acknowledgment letter is sent to the applicant with the OR enclosed, informing them of deficiencies if any.
To determine and evaluate compliance with the rules, regulations, and technical standards, including items such as address/physical plant, personnel, service capabilities, equipment/instruments, reagents, glassware/supplies, laboratory records, duty schedules, rates, procedures, and quality control program.
Within 60 days of the application, unless the convenience of a single inspection trip dictates an earlier inspection.
Inspection is authorized by the Chief of the DLRD and the Director of BRL (or Regional Director/Assistant Regional Director) through a Travel Order or Letter-Request.
In NCR, the BRL Inspection Team inspects all categories of clinical laboratories and blood banks. In the regions, the Team inspects all free-standing and tertiary category of hospital laboratories and all free-standing, secondary and tertiary categories of hospital blood banks. Regional Inspection Teams inspect primary and secondary categories hospital laboratories and primary category hospital blood banks.
In the regions, the completed report is forwarded to BRL only when deficiencies have been corrected; however, after the designated period, the inspection report is forwarded regardless of deficiencies.
If compliance is not verified, deficiencies are informed to the applicant for correction and processing of the license is held in abeyance. When compliance is verified, the Chief of the Division approves preparation of the license; the Director recommends approval to the Undersecretary of Health for Standards and Regulation; and the Undersecretary approves the license.
It may be revoked/suspended/modified in whole or in part if: (1) any material false statement in the application is revealed by inspection records; (2) failure to observe terms/provisions of the rules and regulations; or (3) in cases of willful/repeated violations or where public interest/safety requires otherwise, with prior notice and corresponding investigation generally required.
Except in willful or repeated violations or where public interest/safety requires otherwise, no license is modified/suspended/revoked unless prior notice has been made and a corresponding investigation is conducted.
Only written and/or duly sworn complaints are entertained. The Bureau sends a letter to the pathologist and/or owner requesting comments/explanations; an inspection may be conducted to check the complaint; Chief of the Division and the Director evaluate data; and if found guilty, the Undersecretary may suspend/cancel/revoke without prejudice to criminal action through DOH Legal Division.