TECHNICAL STANDARDS AND REQUIREMENTS FOR THE REGISTRATION, OPERATION AND MAINTENANCE OF CLINICAL LABORATORIES IN THE PHILIPPINES

SECTION 1.       Title . — These standards shall be
known as “Technical Standards and Requirements for the Registration,
Operation and Maintenance of Clinical Laboratories in the Philippines”.

SECTION 2.       Authority . — These technical
standards are issued to implement R.A. 4688 (Clinical Laboratory Law)
with its Revised Rules and Regulations (A.O. 49-B, s. 1988) consistent
with E.O. 119 (Reorganization Act of the Ministry of Health).

SECTION 3.       Purpose . — These standards are
promulgated to protect and promote the health of the people by
preventing the operation of substandard, improperly managed and
inadequately supported clinical laboratories and by improving the
quality of performance of clinical laboratory examinations as well as to
enable the Bureau of Research and Laboratories, Department of Health to
evaluate compliance with such technical standards as requirements for
the issuance of a license.

SECTION 4.       Scope . — The requirements
embodied herein shall apply to primary, secondary and tertiary hospital
clinical laboratories and free-standing (non-hospital) clinical
laboratories.

SECTION 5.       Classification . — Clinical laboratories are classified according to:

1.       Function — It may perform any or all of the following:

1.1. Clinical Pathology includes clinical chemistry, hematology,
microbiology, parasitology, mycology, clinical microscopy, immunology
and serology, immunohematology and blood banking, radioisotope analysis
and laboratory endocrinology and similar discipline.

1.2. Anatomic Pathology includes surgical pathology, histochemistry, immunopathology, cytology and post-mortem examinations.

1.3. Forensic Pathology includes all medico-legal examinations.

2.       Institutional Character — They may either be a:

2.1. Hospital laboratory that operates within a hospital, or

2.2. Free-standing (non-hospital) laboratory that operate on its own or as part of an activity other than a hospital.

3.       Service extent and level — They are either (1) primary;
(2) secondary; or (3) tertiary category depending on the range of
laboratory examinations they perform and the presence of certain
manpower, materials and facilities required.

SECTION 6.       Service Capabilities . — The minimum services required of each respective category of hospital and free-standing clinical laboratories shall be:

Primary Category

1.       Routine Hematology — Complete Blood Count (CBC) which includes:

– Hemoglobin Mass Concentration
– Erythrocyte Volume Fraction ( Hematocrit)
– Leucocyte Number Concentration (WBC)
– Leucocyte Type Number Fraction (Differential Count)

2.       Routine Urinalysis

3.       Routine Fecalysis

4.       Gram Staining

Secondary Category

1.       Routine Hematology, Urinalysis, Fecalysis and Gram Staining

2.       Routine Chemistry

– Blood Glucose Substance Concentration
– Urea Substance Concentration
– Uric Acid Substance Concentration
– Creatinine Substance Concentration
– Cholesterol Substance Concentration
– Total Protein Mass Concentration

Tertiary Category

1.       Routine Hematology, Urinalysis, Fecalysis and Gram Staning

2.       Routine Chemistry

3.       Blood Typing and Cross-matching, donor selection and blood collection for transfusion

4.       Special Chemistry

5.       Special Hermatology

6.       Culture and Sensitivity for Bacteria

SECTION 7.       Standards . — The following
technical standards and requirements are to be complied with by the
following corresponding category of clinical laboratories:

I
Head

The clinical laboratory shall be managed and supervised by a
physician who is licensed and duly registered with the Board of Medicine
(PRC), qualified in laboratory medicine and duly authorized by the
Undersecretary of Health for Standards and Regulation or his duly
authorized representative.

1.  Depending on the category, the following shall be the requirements:

Primary Category:

1.       Free standing Clinical Laboratory shall be
managed by a licensed physician, certified by the Philippine Board of
Pathology in either Anatomic or Clinical Pathology or both.

2.       Hospital Clinical Laboratory (in areas where
Pathologists are not available) may be managed by a certified
pathologist or a physician with training at least three (3) months in
laboratory medicine, quality control and laboratory management and
authorized by the Bureau of Research and Laboratories.

Secondary Category

1.       Hospital and free-standing clinical laboratories shall be managed by a certified pathologist.

2.       Hospital clinical laboratory, in areas where there are
insufficient pathologists, may be managed by a physician with training
of at least three (3) months in laboratory medicine, quality control and
laboratory management and authorized by the Bureau of Research and
Laboratories.

Tertiary Category

1.       Hospital and free-standing clinical laboratories shall be managed by a certified pathologist.

2.       A certified pathologist may be authorized to manage or
supervise or be an Associate in not more than four (4) clinical
laboratories/blood banks.

A physician who is not certified pathologist may be authorized
under Sec. 7, 1-2 of A.O. #49-B, s. 1988, to manage/supervise only one
(1) hospital laboratory.

II
Personnel

The clinical laboratory shall have adequate staff or qualified and
trained personnel with at during hours of laboratory operation, the
number of which is dependent on the workload.

1.  Work assignment shall be consistent with the qualification of the
employee. Emergency laboratory procedures, (i.e. arterial puncture or
potentially hazardous procedures) shall be performed only a qualified
medical staff or duly authorized personnel.

2.  All personnel including the Head, belonging to the professional
group shall maintain a current license issued by the Philippine
Regulation Commission, Philippine Board of Pathology or an authority
from the Bureau of Research and Laboratories.

III
Physical Facilities

The clinical laboratory shall be well- ventillated, lighted, clean
and safe, the physical space sufficient to accommodate its activities.

1.  The technical working space for all categories of clinical
laboratories both hospital and free-standing shall have a minimum area
of:

Category      Space in sq. m.

Primary         10
Secondary    20
Tertiary         60

2.  It should be well- ventillated, adequately lighted, safe and a clean place to work in with an adequate water supply.

IV
Equipment

There shall be provision for a sufficient number and types of
necessary equipment/instruments in order to undertake the different
types of activities or range of laboratory examinations and the volume
of examinations to be done and that they shall comply with safety
requirements.

1.  Hospital and free-standing clinical laboratories shall have the following minimum requirements:

Primary Category

Equipment/Instruments

          Burner/alcohol lamp
          Centrifuge
          Hemacytometer
          Hemoglobinometer
          Hematocrit centrifuge
          Microscope
          Urinometer

Secondary Category

Equipment/Instruments

          Burner/alcohol lamp
          Centrifuge
          Hemacytometer
          Hemoglobinometer
          Hematocrit centrifuge
          Microscope
          Urinometer
          Refrigerator
          Serofuge
          Photometer
          Water bath

Tertiary Category

Equipment/Instruments

          Burner/alcohol lamp
          Centrifuge
          Hemacytometer
          Hemoglobinometer
          Hematocrit centrifuge
          Microscope
          Urinometer
          Blood Counter, differential
          Refrigerator
          Serofuge
          Photometer
          Timer, interval
          Water bath
          Incubator, 35ºC + 2ºC
          Stethoscope
          Trip balance
          Rotator
          Weighing Scale
          Autoclave (in lab/CSR)
          Drying oven

For Anatomic Pathology Services:

          Microtome with knife
          Paraffin oven
          Flotation bath

2.  For other laboratory examinations being performed, the
appropriate equipment necessary for performing such procedures should be
available.

3.  Provisions for the proper functioning and maintenance of the
equipment should be made to ensure quality performance at all times.

V
Glasswares/Reagents/ Supplies

Hospital and free-standing clinical laboratories, primary, secondary
and tertiary categories shall prove the glasswares, reagents and
supplies necessary to undertake the required services.

VI
Quality Control

All clinical laboratories shall have a program of Quality Control
that is sufficiently comprehensive to ensure that reagents, equipment
and methods function as expected thus help and upgrade the standards of
laboratory practices.

1.  There shall be provisions for an internal and external Quality Control Program.

1.1.    Internal Quality Control Program

1.1.1.   There should be proper selection and maintenance of appropriate personnel.

1.1.2.   There should be program for the proper maintenance and monitoring of status of all equipment.

1.1.3.   The program must provide for specific and sensitive methods and appropriate standards.

1.1.4.   There shall be a program to detect deviations from
proper laboratory practices/conditions with the use of quality control
materials.

1.2.    External Quality Control Program

1.2.1.   All clinical laboratories shall participate promptly in
the Quality Assurance Program of the BRL whenever samples for
proficiency testing are received.

1.2.2.   The Satisfactory performance in the proficiency testing shall be one of the criteria for the renewal of license.

1.2.3.   Any refusal to participate in the Quality Assurance
Program of the BRL will be the basis for suspension/revocation of the
license of the laboratory.

VII
Reporting

Laboratory requests shall be construed as consultation between the
requesting physician and the pathologist of the laboratory and as such
should be properly released.

1.  The following shall be observed:

1.1. All laboratory reports on various examinations of specimens shall bear the name of the pathologist or his associate.

1.2. No person in the clinical laboratory shall issue a report,
orally or in writing, whole or portions thereof without a directive from
the pathologist or his authorized associate and only to the requesting
physician or his authorized representative except in emergencies when
the results may be released as authorized by the pathologist.

2.  There shall be provision for an effective method of communication to ensure prompt and reliable reporting.

VIII
Recording

There should be provisions of accurate recording to ensure proper
care of patients, the production of quality results and for medico-legal
purposes.

1.       There must be maintained in the clinical laboratory an
adequate and effective system of recording all requests and reports of
all human specimens submitted and examined.

2.       To prevent erroneous reporting and permit ready
identification and retrieving, there should be provisions for filing,
storage and accession number in addition to patient’s personal
information.

3.       All reports in the clinical laboratory shall be kept in file
for at least one (1) year provided the original report is on file in
the patient’s medical records.

4.       Records of anatomic and forensic pathology should be kept permanently in the laboratory.

There should be a coded system using patients personal and clinical data.

IX
Laboratory Fees

The laboratory and professional fees to be charged for a clinical laboratory examination shall be the prevailing rates.

1.  The rates shall be within the range of the usual fees prevailing
at the time and the particular place taking into consideration cost of
production and quality control of various laboratory procedures.

2.  Professional services rendered to the patient in the performance
of the special procedures or examination shall be treated separately and
not included in the laboratory fee.

This Bureau Order takes effect immediately.

Adopted: 15 Jan. 1990

(SGD.) TOMAS P. MARAMBA, JR.
Officer-In-Charge