Legal basis and reorganization mandate
- The procedures are issued to implement Republic Act No. 4688 (Clinical Laboratory Law) with its Revised Rules and Regulations (A.O. #49-B, s. 1988).
- The procedures are issued to implement Republic Act No. 1517 (Blood Bank Law) with its Revised Rules and Regulations (A.O. #57, s. 1989).
- The issuance is consistent with Executive Order No. 119 (Reorganization Act of the Ministry of Health).
Purpose of the procedures
- The order exists to facilitate the application and licensing of clinical laboratories and blood banks.
- Licensing must be conducted in accordance with the applicable laws and their implementing Revised Rules and Regulations.
License application: requirements
- An applicant must submit a properly accomplished application, required supporting documents, and must pay the corresponding license fee.
- Forms may be secured in person or requested by mail from the Licensure Section, Division of Laboratory Regulation and Development of the Bureau of Research and Laboratories, San Lazaro Compound, Sta. Cruz, Manila, or from the Regional Health Office where the clinical laboratory/blood bank is located.
- For new applications, the required forms are BRL/CL/BB Forms Nos. 1, 2, 3.
- For renewal applications, the required forms are BRL/CL/BB Forms Nos. 2&3.
- For every new application, the required supporting papers and documents are:
- a Xerox copy of the proficiency certificate of the pathologist or head of the clinical laboratory/blood bank;
- a Xerox copy of the current hospital license, except for new hospitals which are not yet licensed;
- a Xerox copy of the Certificate of Registration of Business Name from the Bureau of Domestic Trade; and
- a notarized certification of compliance with other business requirements.
Where and how to file
- Applications are filed either in person or by mail to the Bureau of Research and Laboratories or the Regional Licensing Unit of the Regional Health Office where the clinical laboratory/blood bank is located.
- For applications filed at the BRL, the application may be filed in person or by mail:
- In person: the applicant or authorized representative submits the completed application and required supporting documents to the Licensure Section of the Division of Laboratory Regulation and Development (DLRD) in the Bureau of Research and Laboratories (BRL), Department of Health, San Lazaro Compound, Sta. Cruz, Manila.
- In person: the license fee is paid—usually in cash or postal money order—to the Cashier of BRL using a charge slip issued by the Licensure Section, and penalties and other charges are likewise paid at this time.
- In person: the applicant returns to the Section with the copy of the charge slip and the official receipt (OR) so the OR number can be recorded on the application form and countersigned by the applicant or representative.
- In person: the applicant keeps the OR while the copy of charge slip is filed by the Section.
- In person: only completed and supported applications are processed.
- By mail: the application and license fee are mailed to the BRL through Registered Mail, with the license fee in the form of a postal money order (PMO) payable to the Bureau of Research and Laboratories.
- By mail: upon receipt at the Licensure Section, a charge slip is issued and the PMO is paid to the Cashier of BRL.
- By mail: the OR number is recorded on the application; the charge slip is filed.
- By mail: receipt of the application is acknowledged by mail, and deficiencies, plus any penalties and charges, are communicated in the letter of acknowledgement; the OR is enclosed.
- For applications filed in the Region, the applicant files:
- the application and supporting documents all in duplicate with the Regional Licensing Unit of the Regional Health Office where the clinical laboratory/blood bank is located;
- license fees and other charges through a PMO to the Bureau of Research and Laboratories;
- the PMO, notice and date of receipt, and one copy of the application and documents to the BRL, Licensure Section, DLRD, before PMO expires, via mail or messenger;
- the PMO is paid to the Cashier by Licensure Section using a charge slip;
- receipt is acknowledged through a letter with the OR enclosed; and
- the application is then processed and evaluated.
Recording and application acknowledgment
- A new application received is assigned a number and filed in an individual folder.
- A renewal application is filed in its assigned folder.
- Every application is recorded in the In-Coming Record Book.
- The applicant receives a letter acknowledging receipt of the application with the OR enclosed.
- The applicant is informed of deficiencies in the application if any.
Inspection and evaluation mechanics
- Inspection determines and evaluates compliance with the Rules and Regulations and technical standards, including:
- the address;
- the physical plant;
- the number and names of laboratory personnel;
- service capabilities;
- equipment/instruments;
- reagents, glasswares, and supplies;
- laboratory records;
- schedule of duties, rates, procedures; and
- the quality control program.
- Inspection is authorized by the Chief of the DLRD and the Director of BRL (or Regional Director/Assistant Regional Director) through Travel Order or Letter-Request.
- Ocular inspection of the facility is conducted within 60 days of application, unless the convenience of a single inspection trip dictates an earlier inspection.
- Usually, the inspection date is communicated first to the applicant, who replies to confirm readiness and availability on the scheduled date.
- The prescribed Inspection Form is used for inspection.
- BRL Inspection Team:
- inspects all categories of clinical laboratories and blood banks in the National Capital Region; and
- in the Regions, 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 of hospital laboratories; and
- primary category of hospital blood banks.
Inspection report, license preparation, approval
- After inspection, the Inspection Team submits the duly accomplished and signed inspection report to the Chief of Division within a week after the inspection.
- In the Regions, the completed report is forwarded to BRL only when deficiencies have been corrected.
- In the Regions, after a designated period, the inspection report is forwarded regardless of deficiencies.
- The Chief of Division evaluates the data gathered.
- When compliance is verified, the Chief of the Division approves the preparation of the license.
- If compliance is not verified, the deficiencies are informed to the applicant for corrections while processing is held in abeyance.
- The prepared license is sent to the Director, who recommends approval to the Undersecretary of Health for Standards and Regulation.
- The Undersecretary of Health approves the license.
Releasing, license terms, and changes
- For clinical laboratories/blood banks located in the NCR:
- the original of the license is sent or mailed to the applicant; and
- the duplicate is filed in the Section.
- For those in the Regions:
- the original of the approved license is sent to the Regional Licensing Unit, c/o the Assistant Regional Health Director, for mailing to the applicant; and
- the duplicate is filed in the BRL.
- The license is granted based on specific conditions, and limitations are established during inspection.
- The license and any right under the license cannot be assigned or transferred to an authorized party.
- If the owner transfers the laboratory to another place, the owner must inform BRL in writing within fifteen (15) days after the transfer.
- The laboratory in the new location is subject to inspection.
- If there is a change in the personnel or the head, it must be reported in writing to BRL within fifteen (15) days.
- Failure to report changes in personnel or head may be the basis for suspension or revocation of the license.
Modification, revocation, and complaints investigation
- A license may be revoked, suspended, or modified in full or in part if:
- any material false statement in the application is revealed by the record of inspection; or
- there is failure to observe any terms and provisions of the Rules and Regulations.
- Prior notice and a corresponding investigation are required except where the case involves willful or repeated violations, or where public interest or safety requires otherwise.
- Only written and/or duly sworn complaints are entertained.
- For charges and complaints, the following steps may be done:
- a letter is sent to the pathologist and/or owner against whom the complaint was filed, informing them of the charges and requesting comments and explanations; and
- an inspection is conducted to verify the complaint by gathering pertinent data.
- The gathered data are analyzed and evaluated by the Chief of the Division and the Director of BRL.
- If the person(s) are found guilty of the charges, the Undersecretary of Health shall suspend, cancel or revoke the license, without prejudice to taking the case to judicial authorities through the Legal Division of DOH for criminal action.
Display of license and publications
- The license holder must place the following in a conspicuous place within the clinical laboratory/blood bank:
- License to Open and Operate; and
- the Certificate of Proficiency of the Pathologist or Head.
- A copy of the Rules and Regulations for CL and/or BB must be made readily available.
- The Bureau sends to all concerned for legitimate purposes:
- the list of licensed clinical laboratories and blood banks; and
- the results of the quality control test.