ADMINISTRATIVE

ORDER 2007-0027
Medical Technology Laws
 SUBJECT
• Revised rules and regulations governing the licensure and
regulation of clinical laboratories in the Philippines
 RATIONALE
• Ensure access to quality and affordable health products,
facilities and services

• Physicians utilize laboratory work-ups in aid of diagnosis and

management of patients
• Accuracy of laboratory results is important in assuring and improving
quality
 RATIONALE
• RA 4688 mandates DOH to effectively enforce and update
current regulations for improvement

• Advances in technology necessitate the need to update the

minimum standards and technical requirements
 OBJECTIVE
• To prescribe a revised minimum standard for clinical
laboratories
 SCOPE & COVERAGE
• This AO shall apply to all individuals, agencies, partnerships or
corporations that operate clinical laboratories in the Philippines

• Government clinical laboratories doing microscopy work only for

specific DOH programs shall be exempted from this Order
• Malaria screening, acid fast bacilli microscopy, tests for STIs, cervical
cancer screening using Pap smears
 DEFINITION OF TERMS
• Important terms
• Clinical laboratory
• Critical values
• EQAP
• License
• Licensee
• LTO
 CLASSIFICATION OF CLINICAL
LABORATORIES
A. Ownership
• Government or Private

B. Function
• Clinical Pathology or Anatomic Pathology

C. Institutional Character
• Institution based or Freestanding
 CLASSIFICATION OF CLINICAL
LABORATORIES
D. Service Capability
1. General Clinical Laboratory
• Primary, Secondary, Tertiary category
• Permitted to offer services other than stipulated minimum services
• Comply with requirements to staff, equipment, reagents
• Additional services are listed under its LTO

2. Special Clinical Laboratory

• Offers special laboratory services not provided by general clinical laboratory
• Molecular techniques, Assisted reproduction technology
 GUIDELINES
A. General Guidelines
• LTO is issued to clinical laboratories complying with standards and
requirements by BHFS

• Research clinical laboratories are exempted from licensing but must be

registered with BHFS

• Special clinical laboratories are required to register without being

licensed
• Until appropriate regulations for such purpose is promulgated
 GUIDELINES
• NRL designated by DOH is covered by the license of the clinical
laboratory of the hospital where they are assigned

• POL is required a license if it performs the following

• Issue official laboratory results, performs more than monitoring exams, caters not
only to physician’s own patients

• POCT conducted in a hospital will be under management and

supervision of the licensed clinical laboratory of the hospital
 GUIDELINES
B. Specific Guidelines
1. (a) Human Resource
• Headed by a pathologist certified by Board of Pathology
• Shall have administrative and technical supervision
• Supervise the staff in accordance to standards
• Adequate number of medical technologists and other health professionals with
documented training and experience
• Number of staff shall depend on the workload and services provided
• Staff development training and continuing education programs
 GUIDELINES
1. (b) Equipment. (c) Glasswares, reagents, supplies

(d) Administrative Policies and Procedures

• Written policies and procedures for the provision of services and operations

(e) Technical Procedures

• Documented technical procedures for services provided in each Section of the
laboratory (laboratory procedure manuals)

(f) Quality Assurance Program

 GUIDELINES
1. (g) Communication and Records
• Procedures for receipt and performance of routine and STAT requests
• Procedures for reporting of results including critical values
• All reports shall bear the name and signature of pathologist and the RMT who
performed the examination
• Procedures for reporting of workload, QC, inventory, work schedule
• Procedures for reporting incidents, adverse events, handling complaints
• Retention of laboratory records should follow standards by DOH
• Records kept on file for at least 1 year
• Anatomic and forensic pathology records kept permanently
 GUIDELINES
1. (h) Physical Facilities / Work Environment
• Conform to all applicable local and national regulations for construction and
maintenance
• Conform to required space for conduct of activities
• Primary 10 sqm, Secondary 20 sqm, Tertiary 60 sqm
• Well-ventilated, lighted, clean, safe and functional areas
• Program for proper maintenance and monitoring
• Procedures for waste disposal
• Policies for biosafety and biosecurity

(i) Referral of Examinations outside of Clinical Laboratory

• Memorandum of Agreement with a licensed clinical laboratory performing the test
needed
 LICENSE TO OPERATE
A. Issued in the name of the licensee
• Valid only for the location stipulated on license

B. LTO is valid for one year and expires on the date set by CHD
on the license

C. LTO issued to non-hospital clinical laboratory shall contain:

• Name of clinical laboratory, name of owner, head of the lab, service
capability, period of validity, license number, location
 LICENSE TO OPERATE
D. LTO issued to non-hospital clinical laboratory must be
displayed at all times at a prominent place within laboratory

E. Hospital based clinical laboratories shall be licensed as part of

the hospital

F. Special tests (HIV, water testing), if any, shall be indicated on

the LTO
 LICENSE TO OPERATE
G. Clinical laboratory and its satellite services within same
compound shall have one LTO

H. Satellite laboratory outside the premises where central

laboratory is located shall have a separate LTO

I. If changes are to implemented on the clinical laboratory

• Report to CHD within 2 weeks from initial date of implementation
 LICENSE TO OPERATE
K. LTO may be revoked, suspended, modified for any
• Material false statement by applicant or shown by inspection
• Violation or failure to comply with rules and regulations
 PROCEDURAL GUIDELINES
B. Registration for Application for Initial / Renewal of LTO
• Acquire prescribed forms for LTO from BHFS, CHD or at DOH
• Submit form and all necessary documents to CHD
• Pay non-refundable fee for LTO
• CHD shall conduct inspections in accordance with licensing
requirements
 PROCEDURAL GUIDELINES
C. Renewal of LTO
• Renewal for hospital based clinical laboratories shall be in accordance
with licensing process under One-Stop-Shop Licensure System for
Hospitals
• Non-hospital clinical laboratories shall file applications from October
until November of the current year
• Renewal of license shall be processed not later than 5 working days
• For compliant clinical laboratories
• LTO shall be automatically cancelled without notice upon failure to
submit forms and fees on or before expiration date on the license
 PROCEDURAL GUIDELINES
D. Inspection
• CHD shall conduct announced inspections at any reasonable time
• Licensee ensures accessibility to premises and facilities for inspection
at any reasonable time
• Licensee shall ensure availability of all records for review
• Inspection tool (rubrics / criteria) for monitoring shall be utilized
 PROCEDURAL GUIDELINES
E. Monitoring
• All clinical laboratories shall be monitored regularly
• BHFS or CHD shall monitor through visits at any reasonable time
• All records, premises, facilities of the clinical laboratory shall be made
available to BHFS or CHD
• Notice of Violation shall be issued immediately after monitoring
• CHD concerned shall submit quarterly summary of violations to BHFS
• Provincial, City, Municipal Health Officers are enjoined to report
existence of any unlicensed clinical laboratories or any violations of
rules and regulations
 SCHEDULE OF FEES
• Non-refundable fee shall be charged for application and
renewal of license

• All fees shall be paid to the order of DOH

• All fees, surcharges and discounts shall follow current DOH

prescribed schedule
 VIOLATIONS
• Violations of RA 4688 or any rules and regulations of the
following acts by personnel operating the clinical laboratory

• Violations as listed
 INVESTIGATION OF COMPLAINTS
• BHFS or CHD shall investigate complaint and verify if the
laboratory concerned or any personnel is accountable

• CHD after investigation shall suspend, cancel or revoke for a

determined period the LTO of licensee found violating
provisions of RA 4688 or this Order
 PENALTY
• Person operating a clinical laboratory without license

• Imprisonment of at least 1 month or fine of Php 1,000.00 to Php

5,000.00
• Or both at discretion of the court
 APPEAL
• Decision by BHFS / CHD may be appealed to Office of the
Health Secretary within 10 days after receipt of notice of
decision

• Decision of the Office of the Health Secretary is final and

executory
 EFFECTIVITY
• Order shall take effect 15 days after its approval

• Publication in official gazette or newspaper

• Approved
• August 22, 2007
 REFERENCES
1. Moraleta, N. 2015. Manila, Philippines.

2. Suba, S.C. Milanez, G.D.J. 2017. C&E Publishing, Inc.

Quezon, City, Philippines.