F. Clinical Laboratory Laws (AO 2007-0027)
F. Clinical Laboratory Laws (AO 2007-0027)
F. Clinical Laboratory Laws (AO 2007-0027)
Thus, this Order revises such issuance in order to ensure the quality of services of
clinical laboratories nationwide.
II. OBJECTIVE
• This Order is promulgated to prescribe a revised minimum standard for clinical
laboratories.
• This shall also ensure accuracy and precision of laboratory examinations in order
to safeguard public health and safety.
III. SCOPE AND COVERAGE
This Administrative order:
• shall apply to all individuals, agencies, partnerships or corporations that operate
clinical laboratories in the Philippines
• performing examinations and analysis of samples of tissues, fluids, secretions,
excretions, or other materials from the human body
• that would yield relevant laboratory information:
• which physicians use for the prevention, diagnosis, and treatment of diseases,
• and the management and promotion of personal and public health.
(exemptions to the provisions of AO 2007-0027)
Government clinical laboratories,
• doing microscopy work only for specific DOH programs
such as but not limited to:
• malaria screening,
• acid fast bacilli microscopy,
• test for sexually transmitted infections, and
• cervical cancer screening using Pap smears,
shall be exempted from the provisions of this Order.
IV. DEFINITION OF TERMS
For purposes of this Order, the following terms and acronyms shall have the
following definition:
1. Applicant
• – a natural or juridical person who intends to operate a clinical laboratory
2. BHFS
• – acronym for the Bureau of Health Facilities and Services
3. CHD
• – acronym for the Center for Health Development
4. Clinical laboratory
• – a facility where tests are done on specimens from the human body:
• to obtain information about the health status of a patient
• for the prevention, diagnosis and treatment of diseases.
These tests include, but are not limited to, the following disciplines:
• clinical chemistry, hematology, immunohematology, microbiology, immunology,
clinical microscopy, histopathology, cytology, toxicology, endocrinology,
molecular biology, and cytogenetics.
Other functions of the clinical laboratory
• are to provide consultative advisory services covering all aspects of laboratory
investigations.
Facilities that are involved in the pre–analytical processes:
• such as the collection, handling or preparation of specimens,
• or act as a mailing or distribution center, such as in a laboratory network or system
are also considered to be a part of a clinical laboratory.
2. Private
– owned, established and operated
• by any individual, corporation, association or organization
B. Classification by Function
1. Clinical Pathology
– includes:
• Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology,
Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology
and Therapeutic Drug Monitoring and other similar disciplines
• 2. Anatomic Pathology
– includes:
• Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic
Pathology and Molecular Pathology
C. Classification by Institutional
Character
1. Institution Based
– a laboratory that operates within the premises and as part of an institution,
such as but not limited to:
• hospital, medical clinic, school, medical facility for overseas and seafarers, birthing
home, psychiatric facility, drug rehabilitation center
2. Freestanding
– a laboratory that does not form part of any other institution
D. Classification by Service Capability
1. General Clinical Laboratory
2. Special Clinical Laboratory
1. General Clinical Laboratory
(a) Primary Category – provides the following minimum service capabilities:
2. Clinical laboratories that are operated and maintained exclusively for research
and teaching purposes:
• shall be exempted from the licensing requirement of this Order
• but shall be required to register with the BHFS.
3. Special clinical laboratories that are not subject to the provisions of other
administrative orders:
such as but not limited to:
• Assisted Reproduction Technology Laboratories, Molecular and Cellular
Technology, Molecular Biology, Molecular Pathology, Forensic Pathology,
Anatomic Pathology laboratories operating independent of a clinical laboratory
Are required to register with the BHFS without being licensed under the provisions
of this Order.
Such procedure shall subsist until the appropriate regulation for such purpose is
subsequently promulgated.
Examinations performed in a POL shall only be permitted when they are used
for monitoring patients.
6. A POCT, conducted in a hospital,
- is required to be under the management and supervision of the licensed clinical
laboratory of the respective hospital.
B. SPECIFIC GUIDELINES
1. Standards
(2) The head of the laboratory shall have administrative and technical supervision
of the activities in the laboratory.
(3) The head of the laboratory shall supervise the staff in accordance to the
standards set by the Philippine Society of Pathologists.
(a) Human Resource (continued)
(4) There shall be an adequate number of medical technologists and other health
professionals with documented training and experience to conduct the laboratory
procedures.
• The number of staff shall depend on the workload and the services being provided.
(5) There shall be staff development and continuing education program at all levels
of organization to upgrade the knowledge, attitude and skills of staff.
(b) Equipment
• (1) There shall be available and operational equipment to provide the laboratory
examinations that the laboratory is licensed for.
• (2) There shall be a calibration, preventive maintenance and repair program for
the equipment.
• (2) There shall be an inventory control of the reagents, glassware and supplies.
• (3) The reagents, glassware and supplies shall be stored under the required
conditions.
(d) Administrative Policies and
Procedures
The clinical laboratory shall have written policies and procedures
• for the provision of laboratory services
• and for the operation and maintenance of the laboratory.
(e) Technical Procedures
There shall be documented technical procedures for services provided in each
Section of the laboratory:
• which will ensure the quality of laboratory results.
(f) Quality Assurance Program
• (1) There shall be an Internal Quality Assurance Program which shall include:
• (2) There shall be procedures for the reporting of results of routine and STAT
laboratory examinations, including critical values that would impact on patient
care.
(g) Communication and Records
(continued)
• (3) All laboratory reports on various examinations of specimens shall bear the
name of:
• facsimile signature of the Pathologist who shall be accountable for the reliability
of the results.
• The reports shall also bear the name and signature of the registered medical
technologist(s) who have performed the examinations.
• (5) There shall be procedures for the reporting and analysis of incidents, adverse
events and in handling complaints.
• (2) The laboratory shall conform to the required space for the conduct of its
activities.
• (3) There shall be well–ventilated, lighted, clean, safe and functional areas based
on the services provided.
(h) Physical Facilities/Work Environment
(continued)
• (4) There shall be a program of proper maintenance and monitoring of physical
plant and facilities
• (5) There shall be procedures for the proper disposal of waste and hazardous
substances.
• (b) The LTO is issued to a clinical laboratory, unless sooner suspended or revoked,
• is valid for one year
• and expires on the date set forth by the CHD,
• as stipulated on the face of the license.
2. LTO (License to Operate)
(continued)
• (c) The LTO issued to a non–hospital based clinical laboratory
shall specifically stipulate the following:
• name of the clinical laboratory,
• name(s) of the owner or operator,
• head of the laboratory,
• service capability,
• period of validity,
• license number, and
• location wherein the laboratory procedures are to be performed.
(d) The LTO issued to a non–hospital based clinical laboratory must be displayed at all time at a
prominent place within the laboratory premises.
2. LTO (License to Operate)
(continued)
• (e) Hospital based clinical laboratories:
• shall be licensed as part of the hospital through the One–Stop–Shop Licensure for
Hospitals
• and are therefore not required to obtain a separate license.
• (f) The capability to perform HIV testing and/or drinking water analysis shall be
specifically indicated in the LTO, as issued by the CHD.
2. LTO (License to Operate)
(continued)
• (g) The clinical laboratory and its satellite services within the same compound
shall have one (1) LTO.
• (h) A satellite laboratory outside the premises where the central laboratory is
situated shall be required to secure a separate LTO.
2. LTO (License to Operate)
(continued)
• (i) Mobile clinical laboratories
• shall be licensed as part of the main clinical laboratory and
• shall be permitted to collect specimens only.
It shall be allowed to operate only within one hundred (100) km radius from its
main laboratory.
• (j) The LTO may be 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 violation of, or failure to comply with any of the terms and conditions and
provisions of these rules and regulations.
VII. PROCEDURAL GUIDELINES
A. Registration for Special Clinical Laboratories, National Reference
Laboratories, Research and Teaching Laboratories
B. Procedures for Application for Initial/Renewal of LTO
C. Renewal of LTO
D. Inspection
E. Monitoring
A. Registration for Special Clinical Laboratories, National
Reference Laboratories, Research and Teaching Laboratories
1. Applicants can acquire the prescribed Application Form for Registration from:
• the BHFS,
• CHD that has jurisdiction over the existing or proposed clinical laboratory
• or at the DOH website (www.doh.gov.ph).
A. Registration for Special Clinical Laboratories, National
Reference Laboratories, Research and Teaching Laboratories
(continued)
The applicant shall be required to pay a non–refundable application fee for LTO
upon submission of the accomplished form.
B. Procedures for Application for
Initial/Renewal of LTO (continued)
3. The CHD that has jurisdiction over the existing or proposed clinical laboratory:
• shall conduct inspections in accordance with licensing requirements,
• as provided for under this Order and the One–Stop–Shop Licensure System for
Hospitals.
C. Renewal of LTO
• 1. Renewal of hospital based clinical laboratories shall be in accordance with the
licensing process under the One–Stop–Shop Licensure System for Hospitals.
• 2. Non–hospital based clinical laboratories shall file applications for renewal of LTO
beginning on:
• the first day of October until the last day of November of the current year.
A discount on the renewal fee shall be granted if a complete application filed during
this period.
C. Renewal of LTO (continued)
• 3. Renewal of license for compliant clinical laboratories:
• shall be processed not later than five (5) working days after the expiration date of
its license.
• 2. The licensee shall ensure the accessibility of the premises and facilities where
the laboratory examinations are being performed for the inspection of the CHD
Director or his authorized representative(s) at any reasonable time.
D. Inspection (continued)
• 3. The licensee shall ensure the availability of all pertinent records for
checking/review of the CHD Director or his authorized representative(s).
• 3. All clinical laboratories shall ensure that all laboratory records, premises and
facilities are made available to the BHFS or the CHD Director or his authorized
representative(s) in order to determine compliance with the provisions of this Order.
E. Monitoring (continued)
• 4. A Notice of Violation for non–compliant clinical laboratories shall be issued
immediately after monitoring the clinical laboratory.
• 5. The CHD concerned shall submit a quarterly summary of the violations to the
BHFS stating:
• the name of the clinical laboratory,
• location,
• its corresponding violation
• and the course of action taken.
E. Monitoring (continued)
• 6. The Provincial, City and Municipal Health Officers:
• are enjoined to report to the BHFS /CHD the existence of unlicensed clinical
laboratories or any private party
performing laboratory examinations without proper license
and/or violations to these rules and regulations.
VIII. SCHEDULE OF FEES
A. A non–refundable fee shall be charged for the initial application /renewal of
license to operate a clinical laboratory, either government or private.
B. All fees/checks shall be paid to the order of DOH in person or through postal
money order.
C. All fees, surcharges and discounts shall follow the current DOH prescribed
schedule of fees.
IX. VIOLATIONS
• Violation of Republic Act 4688 or these rules and regulations and/or commission of
the following acts by personnel operating the clinical laboratory under this
authority shall be penalized:
• A. Refusal of any clinical laboratory to participate in an EQAP conducted by the
designated NRL or other external proficiency program approved by the DOH;
• E. Deviation from the standard test procedures including use of expired reagents;
• F. Reporting/release of erroneous results;
• G. Lending or using the name of the licensed clinical laboratory or the head of the
laboratory or medical technologist to an unlicensed clinical laboratory;
• H. Unauthorized use of the name and signature of the Pathologist and medical
technologists to secure LTO;
• I. Reporting a test result for a clinical specimen even if the test was not actually
performed;
The decision of the Office of the Health Secretary is final and executory.
XIII. REPEALING CLAUSE
• Provisions from previous issuances that are inconsistent or contrary to the
provisions of this Order are hereby rescinded and modified accordingly.
XIV. SEPARABILITY CLAUSE
In the event that any provision or part of this Order be declared unauthorized or
rendered invalid by any court of law or competent authority:
• those provisions not affected by such declaration shall remain valid and effective.
XV. EFFECTIVITY
• This Order shall take effect fifteen (15) days after its approval and publication in
the Official Gazette or newspaper of general circulation