PROCEDURES AND GUIDELINES FOR THE REGIONAL CLINICAL LABORATORY AND BLOOD BANK INSPECTION TEAMS OF THE REGIONAL LICENSING UNITS

SECTION 1.       Title . — These Procedures and
Guidelines shall be known as “Procedures and Guidelines for the Regional
Clinical Laboratory and Blood Bank Inspection Teams of the Regional
Licensing Units”.

SECTION 2.       Authority . — These are being
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 Act of the Ministry of Health).
 These guidelines are issued pursuant to Department Circular 6-A, s.
1989 (Consolidation of Licensing Activities and Functions Under the
Office of the Assistant Regional Director)

SECTION 3.       Purpose . — To facilitate the
application and licensing of clinical laboratories and blood banks in
the Regions in accordance with the Laws and their implementing Revised
Rules and Regulations.

SECTION 4.       Functions of the Regional Licensing Units . —

4.1  To issue and accept applications for licenses to operate clinical laboratories and blood banks.

4.2  To inspect primary and secondary category hospital-based
clinical laboratories and primary category hospital-based blood banks.

4.3  To assist and guide applicant laboratories and blood banks so
that deficiencies are corrected within the period set by the Bureau of
Research and Laboratories.

4.4  To submit completed reports to the Bureau of Research and Laboratories, Division of Laboratory Regulation and Development.

4.5  To accept and issue approved licenses to operate and open clinical laboratories and blood banks.

4.6  To be liaison between the central regulatory body (BRL) and
the regional clinical laboratories and blood banks in the task of
maintaining the high standards of Laboratory and Blood Bank Services.

SECTION 5.       Regional Licensing Procedures and Guidelines . —

5.1     Application to operate CL/BB

5.1.1    The Regional Licensing Unit (RLU) specifically the
Clinical Laboratory and Blood Bank Inspection Team headed by the Chief
of the Regional Clinical Laboratory and the Medical Technologist
Inspector shall accept records and file applications submitted in
duplicate to operate Clinical Laboratories and Blood Banks and assign
each application a number.

5.1.2    Postal Money Orders addressed to the Bureau of Research
and Laboratories shall be forwarded together with duplicate copies of
application forms and documents to the BRL in Manila within one week
with the following information:

a.    Date PMO and application is received by the RLU and reference number.

b.    Information re: New or Renewal Application

c.    Category of Laboratory and Blood Bank to be licensed

5.1.3    Deficiencies noted in the application forms are
communicated by RLU to the applicant and should be corrected within 45
days of date of application.

5.2     Inspection

5.2.1    In inspection of the Clinical Laboratory or Blood Bank is made within 60 days of the date of receipt of application.

5.2.2    Initial licensure inspections are announced because they
are basically to verify capability of laboratories or blood banks to
deliver services applied for and to help the staff comply with
administrative and technical documentation now required by law. 
Subsequent inspections may be announced.

5.2.3    The Inspection visit includes:

a.    A brief meeting with the Head or Pathologist, Chief
Medical Technologist and if convenient with the laboratory owner before
and at the end of the inspection.

b.    Completion of the inspection which aims to be an
objective assessment of physical, technical, administrative and manpower
capabilities of the laboratory.

c.    The summation or post-inspection conference is a sharing
and teaching session and may be chaired by the Physician Head of the
Team or one of the Medical Technologist inspectors capable of guiding
the discussion.  To be taken up (a) Noted deficiencies; (b) Ways of
correcting these deficiencies explained and discussed.

5.2.4    A written copy of the deficiencies is left with the
staff and both staff and inspectors sign documents attesting to
knowledge of inspection findings going into the report; certificates of
appearance are also signed.

5.2.5    The laboratory staff are told where to present or mail
evidence of deficiencies corrected or whom to call if a repeat
inspection is required.

5.2.6    The laboratory is given two (2) deficiency letters, one
on the day of inspection and a follow-up in case deficiencies have not
been corrected 30 days after. They are given 60 days after inspection to
correct deficiencies.

5.3     Evaluation

5.3.1    The completed inspection report using BRL Inspection
Forms with all deficiencies corrected are forwarded within 2 weeks of
completion to the Office of the Assistant Regional Director to be sent
to the Bureau of Research and Laboratories.

5.3.2    The Evaluation, Processing and eventual approval or
(disapproval) and issuance of a License takes two weeks after receipt of
the above completed inspection report.

5.3.3    Licenses are sent to the Office of the Assistant
Regional Director for issuance to the applicant Clinical Laboratories
and Blood Banks.

SECTION 6.       Liaison . —

6.1  Applications for licenses to operate tertiary category
hospital-based and all categories of free-standing clinical
laboratories; secondary, tertiary categories and all categories of
free-standing blood banks shall be forwarded to the Bureau of Research
and Laboratories for processing.

6.2  Monthly Reports of Accomplishments are to be submitted to the
BRL by the Clinical Laboratory and Blood Bank Inspection Teams through
the Office of the Assistant Regional Director using the attached form.

This Bureau Order takes effect immediately.

Adopted: 16 Jan. 1990

(SGD.) TOMAS P. MARAMBA, JR., M.D., M.H.A.
Officer-In-Charge