CLINICAL B.

ACCORDING TO INSTITUTIONAL CHARACTERSTICS

LABORATORY
FREE-STANDING
INSTITUTION-BASED
(NON-HOSPITAL)
within a hospital, school, Specializes in chemical,
• Pathology Department
medical clinic, medical facility microbiological and
• “The Lab”
for overseas workers and hematologic
• Facility that performs chemical & microscopic seafarers, birthing home, procedures
examinations of various body fluids like blood & psychiatric facility, drug
tissues rehabilitation center, etc
• The workplace of the medical technologists differentiation of autopsy &
surgical tissues
ALSO INVOLVED IN:
– Research
C. ACCORDING TO OWNERSHIP
– Community outreach
 Government-owned
– Surveillance
 Privately-owned
– Infection control
– Information dissemination
D. ACCORDING TO SERVICE CAPABILITY
– Evaluation of the applicability of diagnostic
technologies
PRIMARY CATEGORY
LABORATORY ASSAYS – minimum service capabilities
 PAST: manual, taxing, labor-intensive and time  Routine Hematology
consuming  Qualitative Platelet Determination
 PRESENT: less laborious, shortened turnaround time  Routine Urinalysis and Fecalysis
(TAT), more reliable results  Blood Typing, Gram staining (hospital-based)
 FUTURE: more changes – Equipment: microscopes, centrifuge, hematocrit
centrifuge
CLASSIFICATIONS – AT LEAST 10 SQM
A. ACCORDING TO FUNCTION
SECONDARY CATEGORY (HOSP & NON-HOSP BASED)

– provides all tests conducted by primary category

plus:
 Routine Clinical Chemistry (Chem 5)
 Quantitative Platelet Determination
 Cross-matching (hospital-based)
 Gram staining (hospital-based)
 KOH test (hospital-based)
– Equipment: primary requirement + semi-automated
chemistry analyzers, autoclave, incubator and oven.
– AT LEAST 20 SQM
– Personnel: depends on the workload

TERTIARY CATEGORY (HOSP AND NON-HOSP BASED)

– provides all tests conducted by secondary category

ANOTOMICAL PATHOLOGY
Diagnosis/confirmation of
diseases through autopsy
examination & cellular
differentiation of autopsy &
surgical tissues
CLINICAL PATHOLOGY
Specializes in chemical,
microbiological and
hematologic
procedures
plus:
 Special Clinical Chemistry
 Special Hematology including coagulation tests
 Immunology and serology
 Microbiology, bacteriology and mycology
 Immunohematology and blood banking
 – Equipment: secondary + automated chem. analyzer,
BSL-II, serofuge, etc.
– AT LEAST 60SQM
NATIONAL REFERENCE LABORATORY
– Government hospitals designated by DOH
– Provide diagnostic functions and services for certain
diseases
– Referral service, confirmatory testing, assistance for
research activities, implementation of External Quality
Assurance Programs (EQAP), resolution of conflicts,
training
LAWS ON THE OPERATION , MAIN TENANC E, AND REGISTRATION
OF CLIN IC AL L ABO RATO RIES IN THE PH IL IPPINES
REPUBLIC ACT NO 4688
An act regulating the operation and maintenance of clinical
laboratories and requiring the registration of the same with
the department of health, providing penalty for the violation
thereof, and for other purposes
SECTION 1
– shall register and secure a license annually at the
office of the Secretary of Health; provided that
government hosp lab doing routine examination
shall be exempt from the provisions of this section if
their services are extensions of government regional
or central laboratories.
SECTION 2
– It shall be unlawful for any person to be
professionally in-charge of a registered clinical
laboratory unless he is a licensed physician duly
qualified in the lab medicine and authorized by the
Secretary of Health, such authorization to be
renewed annually.
SECTION 3
– The Secretary of Health, through the Bureau of
Research and Laboratories shall be charged with the
responsibility of strictly enforcing the provisions of
this Act and shall be authorized to issue such rules
and regulations as may be necessary to carry out its
provisions.
SECTION 4
– Any person, firm or corporation who violates any
provisions of this Act or the rules and regulations
issued thereunder by the Secretary of Health shall be
punished with imprisonment for not less than 1
month but not more than 1 year, or by a fine of not
less than 1,000.00 nor more than 5,000.00, or both
SECTION 5
– If any section or part of this Act shall be adjudged by
any court of competent jurisdiction to be invalid, the
judgment shall not affect, impair, or invalidate the
remainder thereof.
SECTION 6
– The sum of 50,000.00 or so much thereof as may be
necessary, is hereby authorized to be appropriated,
out of any funds in the national Treasury not
otherwise appropriated, to carry into effect the
provisions of this Act
SECTION 7
– All acts or parts of Acts which are inconsistent with
the provisions of this Act are hereby repealed.
SECTION 8
– This Act shall take effect upon its approval
– Approved, June 18, 1966
RULES AND REGUL AT IO NS GOVERNING TH E ES TAB LIS HMEN T,
OPERAT IO N AN D MAINT EN ANC E OF CL IN ICAL LAB ORATORIES IN
TH E PH IL IPPINES
ADMINISTRATIVE ORDER NO. 59 S. 2001
SECTION 1: TITLE
– Rules and Regulations Governing the Establishment,
Operation and Maintenance of Clinical Laboratories
in the Philippines
SECTION 2: AUTHORITY
– Issued to implement R.A. 4688: Clinical Laboratory
Law consistent with E.O 102 series 1999: Redirecting
the Functions and Operations of the DOH. The DOH,
through the Bureau of Health Facilities and Services
(BHFS) in the Health Regulation Cluster, shall
exercise the regulatory functions under these rules
and regulations
SECTION 3: PURPOSE
– promulgated to protect and promote the health of
the people by ensuring availability of clinical
 laboratories that are properly managed with
adequate resources, with effective and efficient
performance through compliance with quality
standards
SECTION 4: SCOPE
1. These regulations shall apply to all entities
performing the activities and functions of clinical
laboratories
2. These regulations do not include government
laboratories doing laboratory examinations limited
to acid fast bacilli microscopy, malaria screening and
cervical cancer screening, provided their services are
declared as extension of a licensed government
clinical lab
SECTION 5: CLASSIFICATION OF CLIN LAB
SECTION 6: POLICIES
1. An approved permit to construct and design layout
of a clinical laboratory shall be secured from the
BHFS prior to submission of an application for a
Petition to Operate.
2. No clinical laboratory shall be constructed unless
plans have been approved and construction permit
issued by the BHFS.
3. A clinical laboratory shall operate with a valid license
issued by BHFS/CHD, based on compliance with the
minimum licensing requirements.
4. The clinical laboratory shall be organized and
managed to provide effective and efficient services.
5. The clinical lab shall provide adequate and
appropriate safety practices for its personnel and
clientele.
SECTION 7: REQUIREMENTS AND PROCEDURES FOR
APPLICATION OF PERMIT TO CONSTRUCT AND
LICENSE TO OPERATE
1. Application for Permit to Construct
Documents required:
a. Letter of application to the Director of BHFS
b. Site Development Plans and Floor Plan
c. DTI/ SEC Registration
2. Application for New License
A duly notarized application form “Petition to Establish,
Operate and Maintain a Clinical Laboratory”, shall be filed
by the owner or his duly authorized representative at the
BHFS.
3. Application for renewal of license
A duly notarized application form “Application for
Renewal of License to Establish, Operate and Maintain a
Clinical Laboratory” shall be filed by the owner or his duly
authorized representative at the respective CHD
a. Renewal of License
- shall be filed within 90 days before the
expiry date
– NCR (Jan. – March)
– 1,2,3 & CAR (Feb. – April)
– 4,5 & 6 (March – May)
– 7,8 & 9 (April – June)
– 10,11,12, CARAGA & ARMM (May – July)
4. Permit and License Fees
a. non-refundable license fee for application for
permit to operate and for license to operate
b. non-refundable fee for application for renewal of
license to operate
c. shall be paid to the Cashier of BHFS/ CHD
d. shall follow the current prescribed schedule of
fees of the DOH
5. Penalties
a. 1,000.00 for late renewal if filed during the next 2
months after expiry date
b. 100.00 for each month for application received
more than 2 months after expiry date
6. Inspection
a. Each license shall make available to the Director of
BHFS/ CHD or representative at any reasonable time
for inspection
b. Each license shall make available to the Director or
his representative(s) all pertinent records
c. shall be inspected every 2 years as necessary
7. Monitoring
a. shall be monitored regularly and records shall be
made available
b. The Director or his representative shall be allowed
to monitor the clin lab at any given time
c. shall make available to the Director or
representative records for monitoring
 8. Issuance of License
– shall be issued by the Director of CHD or his
authorized representative, if the application is
found to be meritorious
9. Terms and Conditions of License
a. granted upon compliance
b. non-transferable
c. desiring to transfer to another location shall
inform the CHD in writing at least 15 days before the
actual transfer
d. new location shall be subject to re-inspection and
shall comply with the requirements
e. an extension lab shall have a separate license
f. Any change affecting the substantial conditions of
the license to operate a lab shall be reported within 15
days in writing by the person(s) concerned, to the BHFS/
CHD for notation and approval. Failure to do so will
cause revocation of the license.
g. license must be placed in a conspicuous
location/area within the laboratory
SECTION 8: VIOLATIONS
1. The license to operate shall be suspended or
revoked by the Secretary of Health upon violation of
R.A 4688 or the Rules and Regulations issued in
pursuance thereto.
2. The following acts committed by the Owner,
President, Managers, Board of Trustees, Director,
Pathologist or its personnel are considered
violations.
a. operations without a certified pathologist or RMT
b. Change of ownership, location, head of lab or
personnel without informing the BHFS and/ or the CHD
c. Refusal to allow inspection by the persons
authorized by BHFS during reasonable hours
d. Gross negligence
e. Any act or omission detrimental to the public
3. The Provincial, City and Municipal Health Officers are
authorized to report to the CHD and BHFS the
existence of unlicensed clin lab or any private party
performing lab exams without proper license and/or
violations of these rules and regulations
SECTION 9: INVESTIGATION OF CHARGES OR COMPLAINTS
The BHFS/CHD or his duly authorized
representative(s) shall investigate the complaint and verify if
the laboratory concerned or any of its personnel is guilty of
the charges.
1. If found violating the provision of R.A 4688, or any of
these rules and regulations, the BHFS/CHD or duly
authorized representative shall suspend, cancel or
revoke for a determined period of time the license,
as well as the authority of the offending person(s),
without prejudice to taking the case to judicial
authority for criminal action.
2. Any person who operates a clinical laboratory
without the license from DOH shall upon conviction
be subject to imprisonment or fine or both at the
discretion of the court. Provided, however, that if
the offender is a firm or corporation, the Managing
Head and/or owner/s thereof shall be liable to the
penalty imposed herein.
3. Any clin lab operating without a valid license or
whose license has been revoked/ cancelled shall be
summarily closed upon order issued by the
BHFS/CHD or his duly authorized representative. The
BHFS/ CHD may seek assistance of the law
enforcement agency to enforce the closure of any
clin lab
4. The closure order issued by the DOH shall not be
rendered ineffective by any restraining order and
injunction order issued by any court, tribunal or
agency or instrumentalities.
S ECT IO N 10: MODIF IC AT IO N AND REVO CATION OF L ICENSE
1. A license maybe revoked, suspended or modified in
full or in part for any material false statement by the
applicant, or as shown by the record of inspection or
for a violation of, or failure to comply with any of the
terms and conditions and provisions of these rules
and regulations.
2. No license shall be modified, suspended or revoked
unless prior notice has been made and the
corresponding investigation conducted except in
cases of willful, or repeated violations hereof, or
where public health interest or safety requires
otherwise.
SECTION 11: REPEALING CLAUSE
• These rules and regulations shall supersede all other
previous official issuances hereof.
SECTION 12: PUBLICATION AND LIST OF LICENSED
CLINICAL LABORATORIES
• A list of licensed clinical laboratories shall be
published annually in a newspaper of general
circulation.
SECTION 13: EFFECTIVITY
• These rules and regulations shall take effect 15 days
after its publication in the Official Gazette, or in a
newspaper of general circulation.
ANNEX A: TECHNICAL STANDARDS AND
MINIMUM REQUIREMENTS
– The clinical laboratory shall be organized to
provide effective and efficient laboratory services
I. STAFFING
1. Shall be managed by a licensed physician certified by
the Philippine Board of Pathology
-if not available, physician with 3 mos training on clin
lab medicine, quality control and lab management may
manage a primary/secondary clin. lab. The training shall be
certified by BHFS
2. shall employ qualified and adequately train
personnel. Work assignment shall be consistent with
the qualification of the concerned personnel.
a. shall have sufficient # of RMT proportional to
the workload and shall be available at all times
during hrs. of lab operations. For hosp-based
lab, at least 1 RMT per shift
3. There shall be staff development and CPE available
at all levels of the organization
II. PHYSICAL FACILITIES
1. well ventilated, adequately lighted, clean and safe
2. working space shall be sufficient
3. adequate water supply
4. working space for all categories shall have the
following measurements: 10, 20, 60 sq. m
III. EQUIPMENT/ INSTRUMENT
1. Sufficient number and types of appropriate
equipment/ instruments and shall comply with
safety requirements
2. For other lab exams being performed, equipment
must also be available
IV. GLASSWARES/ REAGENTS/SUPPLIES
All categories shall provide adequate and appropriate
glassware, reagents and supplies necessary to undertake the
required services
V. WASTE MANAGEMENT
There shall be provisions for adequate and efficient disposal
of waste following guidelines of the DOH and local
government
VI. QUALITY CONTROL PROGRAM
All clin lab shall have a functional QA program
1. Internal Quality Control Program
a. there shall be documented, continuous
competency assessment program for lab personnel
b. the program shall provide appropriate and std. lab
methods, reagents, supplies and equipment
c. There shall be a program for the proper
maintenance and monitoring of all equipment.
d. The program shall provide for the use of quality
reference material
2. External Quality Control Program
a. All labs shall participate in the External QA
program given by designated Reference Laboratories and/ or
other recognized reference lab.
b. A satisfactory performance rating given by a
National Reference Laboratory shall be one of the criteria for
the renewal of license.
c. Any refusal to participate in external QA program
given by the designated National Reference Laboratories shall
be one of the bases for suspension/ revocation of the license
of the lab
VII. REPORTING
Lab request shall be construed as consultation bet. the
requesting physician and the Pathologist of the lab and as
such, lab results shall be released accordingly
1. All reports shall bear the name of pathologist and
RMT (signed by both)
2. No person in the clin. lab shall issue a report, orally
or in writing, whole or portions thereof without a
directive from the Pathologist or his authorized
associate except in emergency cases when results
may be released as authorized by Pathologist
VIII. RECORDING
There shall be system of accurate recording to ensure quality
results
 1. adequate and effective system 2. MICCROBIOLOGY
2. provisions for filing, storage and accession of all
reports - identification of causative agents of diseases
3. shall be kept for at least 1 year - identification of bacteria and fungi
a. anatomic and forensic pathology shall be kept - Divided into bacteriology, mycobacteriology,
permanently mycology and virology
- Samples: blood, other body fluids, stool, tissues,
IX. LABORATORY FEES swabs
- TESTS:
The lab fees and professional fees to be charged for lab  Staining, Isolation, and identification
examination shall be at the prevailing rates  Microscopic visualization
1. The rates shall be within the range of the usual fees  Biochemical tests
prevailing at the time and the particular place, taking  Antigen typing
into consideration the cost of testing and QC of lab  Susceptibility testing
procedures  Preparation of culture media
2. Prof. services shall be charged separately
3. HEMATOLOGY AND COAGULATION STUDIES

– enumeration of cells in the blood and other

Revised Rules and Regulati ons Governing the body fluids
– TESTS:
Licensure and Regulati on of Clinical
 Complete blood count
Laboratories In The Philippines
 Coagulation studies
ADMINISTRATIVE ORDER NO. 2007-0027  Bone marrow smear

 Revision to A.O. No. 59 s. 2001 4. CLINICAL MICROSCOPY

 Objective: “To ensure accuracy and precision of 2 MAJOR AREA

laboratory examinations in order to safeguard public a. routine and special examinations of urine;
health and safety.” examination of other body fluids
b. fecalysis

– mainly urinalysis, but also includes:

SECTIONS OF THE CLINICAL LABORATORY
 includes CSF cell counts
• different sections, different activities and procedures  gastric analysis
• different clinical laboratory personnel  semen analysis
 transudates & exudates analysis
1. CLINICAL CHEMISTRY  parasitology

– Where chemical analysis of body fluids 5. BLOOD BANK/IMMUNOHEMATOLOGY

– Commonly tested: blood and urine
– one of the busiest sections – Blood typing and compatibility testing
– state-of-the-art – Screening of all antibodies and
– fully automated identification of antibodies and blood components
– may be manual as well used for transfusion
– TESTS: – The most critical in the clin. lab.
 FBS, HBA1c – diabetes – Donor screening, recruitment, bleeding and
 Lipid profile – CVD post-donation care
 BUA, BUN, Crea – kidney diseases
6. IMMUNOLOGY AND SEROLOGY
 TP, ALB, Na, K, Cl, enzymes
 – Serum antibodies in certain infectious
agents
– TESTS: VARIABLES THAT MAY CAUSE ERROR
 Serologic tests for syphilis
 Hepatitis
 HIV and other common diseases

7. ANATOMIC PATHOLOGY

A. HISTOPATHOLOGY/CYTOLOGY
– examination of tissues obtained from
biopsy (LIVING) and autopsy (DEAD)

SPECIALIZED SECTIONS OF THE LABORATORY

1. IMMUNOHISTOCHEMISTRY
– combines anatomical, clinical and QUALITY ASSURANCE IN THE CLINICAL LAB
biochemical techniques
– antibodies (monoclonal and polyclonal) – organized, systematic, well-planned, and regularly
bounded to enzymes and flourescent dyes are done with the results properly documented and
used to detect the presence of antigens in consistently reviewed
tissues – involves the entire testing process: pre-analytical,
– diagnosis of some types of cancer (detects analytical (testing), and post-analytical processes
tumor-specific antigens, oncogenes and tumor
suppressor genes)
– neurodegenerative disorders

2. MOLECULAR BIOLOGY AND BIOTECHNOLOGY

– Used different enzymes and other reagents
– DNA and RNA are identified and sequences
to detect diseases
– PCR

LABORATORY 2 MAJOR COMPONENTS

TESTING CYCLE 1. IQAS

- day to day activities to control factors that may

affect results; regular review and audit of results

2. EQAS

- checking performance among clin labs and is

facilitated by designated external agencies
- NRL is the DOH-designated EQAS

NRL-EQAS:
1. NKTI
2. RITM
3. LCP
4. EAMC
5. SACCL