Kisen Kaisha D.

Dagook
1-MT

CHAPTER 8: Nature of the Clinical Laboratory

Clinical Laboratory
Is an essential component of health institutions. Its main task is to provide
accurate and reliable information to medical doctors for the diagnosis, prognosis,
treatment, and management of diseases.
The clinical laboratory is also actively involved in research, community outreach
programs, surveillance, infection control in the hospital and community setting,
information dissemination, and evaluation of the applicability of current and
innovative diagnostic technologies.
The clinical laboratory is the place where specimens are collected from
individuals are processed, analyzed, preserved, and properly disposed.
Clinical laboratories vary according to size, function, and the complexity of tests
performed.

CLINICAL LABORATORY ACCORING TO FUNCTIONS

Clinical Pathology is a clinical laboratory that focuses on the areas of clinical
chemistry, immunohematology and blood banking. medical microbiology,
immunology and serology, hematology, parasitology, clinical microscopy,
toxicology, therapeutic drug monitoring, and endocrinology, among others. It is
concerned with the diagnosis treatment of diseases performed through laboratory
testing of blood and other body fluids.
Anatomic Pathology is a clinical laboratory that focuses on the areas of
histopathology immunohistopathology, cytology, autopsy, and forensic pathology
among other. It concerned with the diagnosis of diseases through microscopic
examination of tissues and organ.

CLINICAL LABORATORY ACCORING TO INSTITUTIONAL PRACTICES

 Institution-based is a clinical laboratory that operates within the premises or
part of an institution such as a hospital, school, medical clinic, medical facility for
overseas workers and seafarers, birthing home, psychiatric facility, drug
rehabilitation center, and others. Hospital-based clinical laboratories are the most
common example of institution- based laboratories.
Free-standing clinical laboratory is not part of an established institution and
the most common example is a free-standing out-patient clinical laboratory.

CLINICAL LABORATORY ACCORING TO OWNERSHIP

Government-owned clinical laboratories are owned, wholly or partially, by
national or local government units.
Examples:
 Clinical and anatomical laboratories of DOH
 San Lazaro Hospital
 Jose R. Reyes Memorial Medical Center.

Privately owned clinical laboratories are owned, established, and operated by

an individual, corporation, institution, association, or organization.
Examples:
 St. Luke's Medical Center

CLINICAL LABORATORY ACCORING TO SERVICE CAPABILITY

Clinical laboratories under the primary category are licensed to perform
basic, routine laboratory testing.
Like:
 routine urinalysis
 routine stool examination
 routine hematology or complete blood count
 Gram staining (if hospital-based).
 Space requirement is at least 10 square meters

Clinical laboratories secondary category (Hospital and non hospital-

based) is licensed to perform laboratory tests being done by the primary
category clinical laboratories along with routine clinical chemistry tests.
Like:
  blood glucose
 concentrations
 blood urea nitrogen
 blood uric acid
 blood creatinine
 cholesterol determination.
 A minimum requirement of 20 square meters is needed for the floor
area.

Clinical laboratories under the tertiary category (Hospital and non

hospital based) are licensed to perform all the laboratory tests performed
in the secondary category laboratory.
Like:
 Immunology
 serology
 microbiology
 bacteriology
 mycology
 special clinical chemistry
 special hematology
 immunohematology
 blood banking
 Tertiary laboratories have a minimum floor area requirement of at
least o square meter. Equipment requirements include those seen in
secondary category laboratories along with automated chemistry
analyzer, biosafety cabinet class 11, serofuge, among others.

National Reference Laboratory is a laboratory in a government hospital

designated by the DOH to provide special diagnostic functions and
services for certain diseases.
LAWS ON THE OPERATION, MAINTENANCE, AND REGISTRATION OF CLINICAL
LABORATORIES IN THE PHILIPPINES
Republic Act No. 4688
- An act regulating the operation and maintenance of clinical laboratories and requiring
the he registration of the same with the department of health, providing penalty for the
violation thereof, and for other purposes.
SECTION 1. Any person, firm or corporation, operating and maintaining a
clinical laboratory in which body fluids, tissues, secretions, excretions and
radioactivity from beings or animals are analyzed for the determination of
the presence of pathologic organisms, processes and/or conditions in the
persons or animals from which they were obtained, shall register and
secure a license annually at the office of the Secretary of Health:
provided, that government hospital laboratories doing routine or minimum
laboratory examinations 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 laboratory medicine and authorized by the Secretary of
Health, such authorization to be renewed annually, No license shall be
granted or renewed by the Secretary of Health for the operation and
maintenance of a clinical laboratory unless such laboratory is under the
administration, direction and supervision of an authorized physician, as
provided for in the preceding paragraph.
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 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 one
month but not more than one year, or by a fine of not less than one
thousand pesos nor more than five thousand pesos, or both such fine and
imprisonment, at the discretion of the court.
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 fifty thousand pesos, 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.
ADMINISTRATIVE ORDER NO. 59 S. 2001
RULES AND REGULATIONS GOVERNINGTHE ESTABLISHMENT, OPERATION
AND MAINTENANCE OF CLINICAL LABORATORIES IN THE PHILIPPINES
Section 1: Title. This Administrative Order shall be known as the "Rules and
Regulations Governing the Establishment, Operation and Maintenance of Clinical
Laboratories in the Philippines."
Section 2: Authority. These rules and regulations are issued to implement R.A.
4688: Clinical Laboratory Law consistent with EO. 102 series 1999: Redirecting
the Functions and Operations of the Department of Health. The Department of
Health (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. These rules and regulations are 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 which shall include the examination
and analysis of any or all samples of human and other related tissues, fluids,
secretions, radioactive, or other materials from the human body for the
determination of the existence of pathogenic organisms, pathologic processes or
conditions in the person from whom such samples are obtained. 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 laboratory.

Section 5: Classification of Laboratories

1. Classification by Function
Clinical Pathology
 Hematology
 Clinical Chemistry
 Microbiology
 Parasitology
 Mycology
 Clinical Microscopy
  Immunology and Serology
 Immunohematology
 Toxicology
 Therapeutic Drug Monitoring
Anatomic Pathology
 Surgical Pathology
 Immunohistopathology
 Cytology
 Autopsy
 Forensic Pathology
2. Classification by Institutional Character
 Hospital-based laboratory
- a laboratory that operates within a hospital
 Non-hospital-based laboratory
- a laboratory that operates on its own.
3. Classification by Service Capability
 Primary- provides the minimum service capabilities such as:
A. Routine Hematology (Complete Blood Count or CBC)
 Hemoglobin Mass Concentration
 Erythrocyte Volume Fraction (Hematocrit)
 Leucocyte Number Concentration (WBC count)
 Leucocyte Type Number Fraction (Differential Count).
 Qualitative Platelet Determination

B. Routine Urinalysis
C. Routine Fecalysis
D. Blood Typing - hospital-based
E. Quantitative Platelet Determination - hospital-based
 Secondary - provides the minimum service capabilities of a primary category
and the following
A. Routine Clinical Chemistry
 Blood Glucose Substance Concentration Blood Urea Nitrogen Concentration
  Blood Uric Acid Substance Concentration Blood Creatinine Concentration
 Blood Total Cholesterol Concentration
B. Crossmatching
 Tertiary - provides the secondary service capabilities and the following:
A. Special Chemistry
B. Special Hematology
C. Immunology /Serology
D. Microbiology
Section 6: Policies
1. An approved permit to construct and design layout of clinical laboratory shall be
secured form 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
constraction 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 (Annex A).
4. The clinical laboratory shall be organized and managed to provide effective and
efficient laboratory services.
5. The clinical laboratory 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
The following are the documents required:
 Letter of Application to the Director of BHFS
 Four (4) sets of Site Development Plans and Floor Plans approved by an
architect and/or engineer,
 DTI/SEC Registration (for private clinical laboratory)
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 CIHD.
4. Permit and License Fees
 A non-refundable license fee shall be charged for application for permit to
construct, and for license to operate a government and private clinical
laboratory.
 A non-refundable fee shall be charged for application for renewal of license to
open up and operate.
 All fees shall be paid to the Cashier of the BHFS / CHD.
 All fees shall follow the current prescribed schedule of fees of the DOH.
5. Penalties
 A penalty of one thousand pesos (P1,000.00) for late renewal shall be charged in
addition to the renewal fee for all categories if the application is filed during the
next two (2) months after expiry date.
 An application received more than two (2) months after expiry date shall be fined
one hundred pesos (P100.00) for each month thereafter in addition to the
P1,000.00 penalty.

6. Inspection
 Each license shall make available to the Director of the BHFS / CHD or his duly
authorized representative (s) at any reasonable time, the premises and facilities
where the laboratory examinations are being performed for inspection.
 Each license shall make available to the Director of the BHFS / CHD or his duly
authorized representative (s) all pertinent records.
 Clinical laboratories shall be inspected every two (2) years or as necessary.
7. Monitoring
  All clinical laboratories shall be monitored regularly and records shall be made
available to determine compliance with these rules and regulations
 The Director of the BHFS/CHD or his authorized representative(s) shall be
allowed to monitor the clinical laboratories shall be monitored regularly and
records shall be made to monitor the clinical laboratory at any given time.
 All clinical laboratories shall make available to the Director of the BHFS or his
duly authorized representative(s) records for monitoring.
8. Issuance of license
 The license shall be issued by the Director of the CHD or his authorized
representative the application is found to be meritorious.
9. Terms and Conditions of License
 The license is granted upon compliance with the licensing requirements.
 The license is non-transferable.
 The owner or authorized representative of any clinical laboratory desiring to
transfer a licensed clinical laboratory to another location shall inform the CHD in
writing at least 15 days before actual transfer.
 The laboratory in its new location shall be subject to re-inspection and shall
comply with the licensing requirements.
 An extension laboratory shall have a separate license.
 Any change affecting the substantial conditions of the license to operate a
laboratory 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 the
revocation of the license of the clinical laboratory.
 The clinical laboratory license must be placed in a conspicuous location/area
within the laboratory.

Section 8: Violations
1. The license to operate a clinical laboratory shall be suspended or revoked by the
Secretary of Health upon violation of R.A. 4688s 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.
 Operation of a clinical laboratory without a certified pathologist or without
registered medical technologist
  Change of ownership, location, head of laboratory or personnel without
informing the BHFS and/or the CHD.
 Refusal to allow inspection of the clinical laboratory by the person(s)
authorized by he BHFS during reasonable hours
 Gross negligence
 The Provincial, City and Municipal Health Officers are authorized to report to
the CHD and BHFS the existence of unlicensed clinical laboratories or any
private party performing laboratory examinations without proper license
and/or violations to these rules and regulations.
Section 9: Investigations of Charges or complaints
- The BHFS/CHD or his duly authorized representative(s) shall investigate the
complaint and verity if the laboratory concerned or any of its personnel is guilty of
the charges.
 If upon investigation, any person is found violating the provision of R.A. 4688, or any
of these rules and regulations, the BHFS/CHD or his duly authorized
representative(s) shall suspend, cancel or revoke for a determined period of time the
license, as well as the authority’s the offending person (s) without prejudice to taking
the case to judicial penalty authority for criminal action.
 Any person who operates a clinical laboratory without the proper license from the
Department of Health shall upon conviction be subject to imprisonment for not less
than 1 month but not more 1 year or a fine of not less than P1,000.00 and not more
than P5000.00 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 e imposed herein.
 Any Clinical Laboratory 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 the assistance of the
law enforcement agency to enforce the closure of any clinical laboratory.
 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.

Section 10: Modifications and Revocation of License

- A license maybe revoked, suspended or modified in full or in 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.
- No license shall be modified, suspended or revoked unless prior notice has been
made and the corresponding investigation conducted except in 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
circulation.
Section 13: Effectivity
- These rules and regulations shall take effect 15 days after its publication in the Official
Ganette, or in a newspaper of general circulation.

TECHNICAL STANDARDS AND MINIMUM REQUIREMENTS

STAFFING
1. The clinical laboratory shall be managed by a licensed physician certified ha
Philippine Board of Pathology. In areas where pathologists are not available, a
physician with three (3) months training on clinical laboratory medicine, quality control
and laboratory management, may manage a primary/secondary category clinical
laboratory BHFS shall certify such training.
2. The clinical laboratory shall employ qualified and adequately train personnel Work
assignment shall be consistent with the qualification of the concerned personnel.
 A clinical laboratory shall have sufficient number of registered medical
technologists proportional to the workload and shall be available at all times
during hours of laboratory operations. For hospital-based clinical laboratory.
there shall be at least one registered medical technologist per shift to cover the
laboratory operation.
3. There shall be staff development and appropriate continuing education program
available at all levels of the organization to upgrade the knowledge, attitudes and skills
of staff.
PHYSICAL FACILITIES
 The clinical laboratory shall be well-ventilated, adequately lighted, clean and
safe.
 The working space shall be sufficient to accommodate its activities and allow for
smooth and coordinated work flow.
 There shall be an adequate water supply.
 The working space for all categories of clinical laboratories (both hospital and
non-hospital-based) shall have at least the following measurements:
 CATEGORY SPACE IN SQ
PRIMARY 10
SECONDARY 20
TERTIARY 60

EQUIPMENTS
 There shall be provisions for sufficient number and types of appropriate
equipment/instruments in order to undertake all the activities and laboratory
examinations. This equipment shall comply with safety requirements.
 For other laboratory examinations being performed, the appropriate equipment
necessary for performing such procedures shall be made available.
GLASSWARES/REAGENTS/SUPPLIES
 All categories of clinical laboratories shall provide adequate and appropriate
glassware, reagents and supplies necessary to undertake the required
services.
WASTE MANAGEMENT
 There shall be provisions for adequate and efficient disposal of waste
following guidelines of the Department of Health and the local government.
QUALITY CONTROL PROGRAM
 All clinical laboratories shall have a functional Quality Assurance Program
1. Internal Quality Control Program
 There shall be a documented, continuous competency assessment program
for all laboratory personnel.
 The program shall provide appropriate and standard laboratory methods,
reagents and supplies and equipment.
 There shall be a program for the proper maintenance and monitoring of all
equipment.
 The program shall provide for the use of quality control reference materials.

2. External Quality Control Program

 All clinical laboratories shall participate in an External Quality Assurance
Program given by designated National Reference Laboratories and/or other
recognized reference laboratories.
 A satisfactory performance rating given by a National Reference Laboratory
shall be one of the criteria for the renewal of license.
 Any refusal to participate in an External Quality Assurance Program given by
the designated National Reference Laboratories shall be one of the bases for
suspension.
 REPORTING
 Laboratory requests shall be construed as consultation between the requesting
physician and the Pathologist of the laboratory and as such laboratory results
shall released accordingly.
 All laboratory reports on various examinations of specimens shall bear the name
of the registered medical technologist and the Pathologist and duly signed by
both.
 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 to the requesting physician or his authorized representative except in
emergency cases when the results may be released as authorized by the
Pathologist.
RECORDING
 There shall be a system of accurate recording to ensure quality results.
 There shall be an adequate and effective system of recording requests and
reports of all specimens submitted and examined.
 There shall be provisions for filing, storage and accession of all reports.
 All laboratory records shall be kept on file for at least one (1) year.
 Records of anatomic and forensic pathology shall be kept permanently in the
laboratory.
LABORATORY FEES
 laboratory and professional fees to be charged for laboratory examination shall
be at the prevailing rates.
 The rates shall be within the range of the usual fees prevailing at the time and
the particular place, taking into consideration the cost of testing and quality
control of various laboratory procedures.
 Professional services rendered to the patient in the performance of special
procedures or examinations shall be charged separately and not included in the
laboratory fee/s.

SECTIONS OF THE CLINICAL LABORATORY

 A clinical laboratory is made up of different sections cohesively and

comprehensively performing different activities and procedures for each
specimen collected from patients to produce reliable test results.
Clinical Chemistry
  This section is intended for the testing of blood and other body fluids to quantify
essential soluble chemicals including Waste products useful for the diagnosis of
certain diseases. Blood and urine are the two most common body fluids
subjected for analyses in this section.
Examples of tests performed:
 FBS
 Hba1c
 HDL and LDL
 TAG
 Bua
 BUN
 Internal Quality Assurance, Continuous Quality Improvement, and participation in
National External Quality Assurance Program are important activities that
medical technologists perform and are responsible for.
Microbiology
 This section is subdivided into four sections: bacteriology, mycobacteriology,
mycology. and virology. At present, the work in this section is more focused on
the identification of bacteria and fungi on specimens received. Specimens usually
submitted are blood and other body fluids, stool, tissues, and swabs from
different sites in the body.

Hematology and Coagulation Studies

 This section deals with the enumeration of cells in the blood and other body fluids
(e.g., r pleural fluid, etc.).
The examinations done in this section include:
 complete blood count ORC
  hemoglobin
 hematocrit
 WBC differential count
 red cell morphology and cell indices
 antitative platelet count
 total cell count and differential count
 blood smear preparation
 d staining for other body fluids
 Coagulation studies focus on blood testing for the determination of various
coagulation factors.

Clinical Microscopy
 There are two major areas in this section of the laboratory. The first area is
allotted to routine and other special examinations of urine such as macroscopic
examinations to determine color, transparency, specific gravity, and pH level, and
microscopic examinations to detect presence of abnormal cells and/or parasites
as well as to quantify red cells and WBC and other chemicals found in urine.
 The second area is assigned to the examination of stool or routine like Fecalysis.
Detection and identification of parasitic worms and ova are the primary activities
in this area.
Blood Bank/Immunohematology
Blood typing and compatibility testing are the two main activities performed in this
section. Screening for all antibodies and identification of antibodies as well as the
blood Components used for transfusion are also conducted in this section. In
hospital-based clinical laboratories, blood donation activities prompt other
activities such as donor recruitment and screening, bleeding of donor, and post-
donation care.
Immunology and Serology
 Analyses of serum antibodies in certain infectious agents (primarily viral agents)
are performed in this section. Hepatitis B profile tests, serological tests for
syphilis, and tests for hepatitis C and dengue fever are some examples of
antibody screening tests. Similar to Clinical Chemistry and Hematology sections,
automated analyzers are commonly used in this section when performing
different serological tests.
ANATOMICAL PATHOLOGY
Section of Histopathology/Cytology
 Activities performed in this section include tissue (removed surgically as in biopsy
and autopsy) processing, cutting into sections, staining, and preparation for
microscopic examination by a pathologist.
SPECIALIZED SECTIONS OF THE LABORATORY IMMUNOHISTOCHEMISTRY
 It is a specialized section of the laboratory that combines anatomical, clinical,
biochemical techniques where antibodies (monoclonal and polyclonal) bounded
to enzymes and fluorescent dyes are used to detect presence of antigens in
tissue. This is useful in the diagnosis of some types of cancers by detecting the
presence of tumor-specific antigens, oncogenes, and tumor suppressor genes.
Molecular Biology and Biotechnology
 One of the exciting developments in medical technology is molecular biology and
biotechnology diagnostics. Primarily using different enzymes and other reagents,
DNA and RNA are identified and sequenced to detect any pathologic
conditions/disease processes the most common technique currently in use is the
polymerase chain reaction (PCR).

LABORATORY TESTING CYCLE

 The laboratory testing cycle encompasses all activities starting from a medical
doctor writing a laboratory request up to the time (called the turnaround time
(TAT) the results are generated and become useful information for the
treatment and management of patients This cycle has three phases, namely,
pre-analytic, analytic, and post-analytic.
The pre-analytic phase includes the receipt of the laboratory request, patient
preparation, specimen collection and proper transport and processing of
specimen to the clinical laboratory.
The analytic phase deals with the actual testing of the submitted/collected
specimen.
The post-analytic phase includes the transmission of test results to the medical
doctor for interpretation, TAT, and application of doctor's recommendations.

QUALITY ASSURANCE IN THE CLINICAL LABORATORY

 Quality assurance (QA) encompasses all activities performed by laboratory
personnel to ensure reliability of test results.
 Quality assurance in the clinical laboratory has two major components:
Internal Quality Assurance System (IQAS) and External Quality Assurance
System (EQAS), IQAS include day-to-day activities that are undertaken in
order to control factors or variables that affect test results. Regular review and
audit of results are done in order to identify weakness and consequently
 perform corrective actions, EQAS, on the other hand, is a system on checking
performance among clinical laboratories and is facilitated by designated
external agencies. The National Reference Laboratories (NRL) is the DOH-
designated EQAS.
At present, the designated NRL-EQAS are the following:
National Kidney and Transplant Institute – Hematology and Coagulation
Research Institute of Tropical Medicine - Microbiology (identification and
antibiotic susceptibility testing) and Parasitology (identification of ova and
quantitation of malaria)
Lung Center of the Philippines – Clinical Chemistry (for testing 10 analytes,
namely glucose, creatinine, total protein, albumin, blood urea nitrogen, uric acid,
cholesterol, sodium, potassium, and chloride)
East Avenue Medical Center- Drugs of abuse (methamphetamine and
cannabinoids)
San Lazaro Hospital Cooperative Center Laboratory– Infectious immunology
hepatitis B surface antigen, human immunodeficiency virus, hepatitis C virus.