LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS

RA 4688 (Clinical Laboratory Law)

AO 2007-0027 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical
Laboratories in the Philippines)

RA 4688
 Was passed on 1966 – its provisions may sound obsolete nowadays, therefore the AO was passed.
 Section 1: all labs should be licensed and regulated by the DOH (except government labs doing minimum lab
exams)
o Once the lab has already a license it is now subjected to repeated regulations by the DOH.
o The purpose licensing and regulating is for the department or the Government will be ensured that
the Laboratory is performing well. Since laboratories produce results that are used by physicians –
therefore if there is no regulation is place, any laboratory can just create or manufacture fictitious
results, or may not perform the tests accurately – and that could damage the healthcare.
 Section 2: licensed physicians should be in-charge of the labs
o Nowadays the pathologist is the one who is in-charge of the laboratory
 Section 3: DOH-BRL is the one in-charge with the implementation of this act and to issue rules and
regulations
o BRL does not exist anymore
 Section 4: punishment for violators (1 month-1 year imprisonment, 1000-5000 pesos fine)
 Section 5: Separability Clause
 Section 6: Php 50,000 from the National Treasury are appropriated to carry out this act
 Section 7: Repealing Clause
 Section 8: Effectivity (June 18, 1966)

AO 2007-0027
 The currently followed regulation, which was passed on 2007 and was signed last 2007
 Objective: prescribe a revised minimum standard for clinical laboratories in the Philippines
o A person cannot just open a lab that has not been evaluated by the DOH.
 Scope and Coverage: all individuals, agencies, partnerships, and corporations that operate clinical
laboratories in the Philippines
 Exceptions: government labs doing microscopy work for DOH programs (malaria, AFB, STDs, Pap smear, tb)
o These labs do not necessarily release or issue results and do not accept patients because they are
just focused on public health programs.

Definition of Terms:

 APPLICANT: a person who intends to operate a lab

 BHFS: Bureau of Health Facilities and Services (Current name of BRL).
o Assigned with the regulation of laboratories in the Philippines.
 CHD: Center for Health Development
o The original arm of the DOH
o Alter ego of the DOH
o CHD region 11 – DOH region 11
 CLINICAL LABORATORY: facility where tests are done on body specimens to obtain info about the health
status of the patients for the prevention, diagnosis, and treatment of diseases
 CRITICAL VALUES: panic values; life-threatening
o Lab results wherein if found in the results of the patients will create panic in the laboratory.
o Under these situations, the laboratory must be prepared. The lab must have programs or
procedure on what to do – retest or dilute, or re-perform manual examinations on the samples,
to avoid erroneous diagnosis, or erroneous treatment for the patient
o Check machines

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LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS
o Perform quality control
 DOH: Department of Health
 EQAP: External Quality Assessment Program
o DOH tests the laboratory by sending unknown samples to be tested, and will be sent back to the
laboratory that sent the unknown sample. Their result and your result must coincide.
 INSPECTION TOOL: checklist
o Checklist used by the DOH whenever they inspect the laboratory, so institutions or any
corporate body or establishment organized for a specific purpose license, this is the document.
 INSTITUTION: a corporate body or establishment organized for a specific purpose
 LICENSE: document issued by the DOH to anyone that operates a lab upon compliance with the
requirements
 LICENSEE: the individual or agency to whom the license is issued
o Formerly an applicant
 LTO: License to Operate
o Will be given once the lab has passed the checklist or inspection tool created by the DOH
 MOBILE CLINICAL LABORATORY: a lab testing unit that moves from one site to another; should have a
base lab
o No Mobi-lab should exist on its own. (layk dili pwede walay base lab. Char)
 MONITORING EXAMINATIONS: tests done in series to a patient
o Platelet count from a dengue patient
 NRL: National Reference Laboratory (confirmation, surveillance, resolution of conflicts, training,
research, evaluation)
o Gold standard laboratories for sample results.
o They are also the ones who send EQAP
o There are 6 NRLs in the Philippines:
 Research Institute for Tropical Medicine
 San Lazaro Hospital (SACCL)
 East Avenue Medical Center
 NRL for drug testing.
 National Kidney and Transplant Institute
 Philippine Heart Center
 Lung Center of the Philippines
 POL: Physician's Office Laboratory
 POCT: Point-of-care Testing
 ROUTINE TESTS: basic and commonly requested
o FBS, CBC, Urinalysis, etc.
 SATELLITE TESTING SITE: a site that performs lab exams outside the physical confines of a licensed lab
 STAT TESTS: done on urgent cases
 COR: Certificate of Registration

Classification of Clinical Laboratories

 Ownership
o Government
 Funded by the government.
o Private
 Operators / owners are private individuals or corporations, or partnerships.
 Function
o Clinical Pathology
 CBC, Urinalysis, FBS, Immuno-sero, Blood banking, Hematology, all major commonly
requested tests.

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LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS
o Anatomic Pathology (Surgical Patho, Immunohistopath, Cytology, Autopsy, Forensic Patho,
Molecular Patho)

 Institutional Character
o Institution-based
 Attached on a hospital/ institution
o Freestanding
 Acculab, etc
 Service Capability: General, Special
o General Clinical Laboratory: Primary, Secondary, Tertiary, Limited Service
 PRIMARY
 Routine Hematology
o WBC differential count
 Qualitative Platelet
o Many, few – wala ga state ug numbers, but the doctor will have an idea as to
how many platelets are still present on the patient’s sample.
 Routine Urinalysis/Fecalysis
 Blood Typing (hospital-based)
o If the lab is free standing, it cannot perform blood typing
 SECONDARY
 all the services of primary lab
 Routine Clinical Chemistry (Glucose, BUN, UA, Crea, Total Chole)
 Quantitative Platelet
o Reporting of platelet count by a number. More specific.
 Crossmatching (hospital-based)
 Gram staining (hospital-based)
 KOH (hospital-based)
o Qualitative test to determine the fungal elements from a patient’s sample.
 TERTIARY
 all the services of a secondary lab
 Special Chemistry
 Special Hematology
o Pro-time, APTT, ESR, Immuno-tests, and Microbiology tests
o Sometimes secondary labs can perform microbiology tests and immunology
tests. However, this must be specified in their LTO.
 The government allows this only if they underwent inspection. Layk
ma satisfy sa nila dapat ang DOH
 Immunology
 Microbiology
 LIMITED SERVICE: dialysis centers, social hygiene clinics.
 Labs that only perform specific tests required in accordance to the specific centers.
For instance, dialysis center laboratories only have services that are requires to the
patients (Such as hemoglobin tests, hepatitis B, Creatinine tests).
o Dialysis centers
o Social hygiene clinics
 Only STD tests are done here
o Special Clinical Laboratory: services not provided by general labs
 Provides tests or services that are not provided by general laboratories.

GENERAL GUIDELINES

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LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS
 How licensing is performed.
 research and teaching labs/special clinical labs: exempted from licensing (Since they do not really cater a
vast number of patients) but are required to register with the BHFS
 Hospital-based NRL: covered by the license of the assigned hospital lab
o independent NRL: register only with BHFS provided they are accredited by the CDC, WHO, or
local/int'l accrediting body. Once the accreditation is done, that is the only time that they can apply
for a COR from the BHFS again.
 Not required to secure an LTO, it’s only required to secure a COR from BHFS
 POL: tests should be for monitoring only (license: issue official lab results, perform more than monitoring
tests, cater to other patients)
o Only allowed to operate license only if they are performing monitoring tests.
o Monitoring tests: For example, dermatologist ka, so endocrinologist jud ka unya naa kay sub-
specialization sa diabetes mellitus0. So pwede nimo imonitor ang glucose level sa imong patient.
Now what if gusto pud nimo mag urinalysis ug mag fecalysis, kailangan na nimo ug license kay naga
go beyond naka sa role sa POL
 POCT: should be under the management and supervision of the licensed clinical lab of the hospital
o As much as possible, only med-techs must perform POCTS, otherwise in cases of emergencies in the
emergency room, there should be an existing agreement between the lab and the emergency room.

SPECIFIC GUIDELINES
 Human Resource
o headed and managed by a pathologist
o adequate number of MTs with training and experience
o staff development and continuing education programs (trainings and seminars)
 Equipment
o available and operational equipment
o calibration, preventive maintenance, repair program
o contingency plans
 what to do, and what not to do in machine malfunctions
 Glassware, Reagents, and Supplies
o available for lab exams
o inventory control and proper storage
 Administrative Policies and Procedures
o written policies and procedures for the services provided and for operation and maintenance
 Technical Procedures
o procedures for each section of the lab
 Quality Assurance Program
o Internal
 wherein the med techs working in the lab will perform the quality assurance
o External
 Sending of NRLs of unknown samples to labs for analysis.
 Communication and Records
o There should be existing policies published in the lab on how to receive and/or reject samples.
 Rejection criteria should be written down
 When to accept stat tests
 How stat tests are defined
 How to report routine and stat tests
 What is the matter of reporting
 What is the allotted turn-around-time for stat tests
o for receipt, performance, and reporting of routine and STAT tests

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LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS
o name and facsimile of the pathologist (accountable for the reliability of results) and the performing
MT
o retention of lab records

 Communication and Records

o reporting of workload, QC, inventory, schedule, and assignments
o reporting and analysis of incidents, complaints, and adverse events
 Physical Facilities/Work Environment
o space, cleanliness, ventilation, maintenance/monitoring of facilities, proper disposal, biosafety
o Primary (10 sq.m.), secondary (20 sq.m.), tertiary (60 sq.m.)
 Referral of Examinations Outside the Lab
o MOA, assurance of quality of services
o Delivered by a medtech
 LTO
o issued in the name of the licensee, non-transferable
o valid for 1 year (renewed every year)
o hospital-based: one-stop-shop licensing for
hospitals
 no need for the chief medtech to
secure the license.
o non-hospital based: individual filing
o Must be displayed at all times
 Evidence that the lab is performing
well and releasing accurate results.
o HIV testing and water analysis: specific
indication (should be indicated on the LTO)
o Test that do not fall on the lab’s category
must be specified on the LTO
o lab and satellite within the premises: one
LTO
 LTO is issued to the base lab only if
the satellite-lab is located at the
premises of the base lab.
Otherwise, a separate license is
needed to operate.
o lab and satellite outside the premises:
separate LTOs
o mobile labs: licensed as part of the base
lab; allowed to collect specimens only
within a 100-km radius from the base lab
 A way of the laboratory to reach far
flung areas and be able to collect samples from far away places.
o changes: report to CHD within 2 weeks from implementation
o Head of the lab is a certified pathologist, both anatomic and clinical.

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LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS
PROCEDURAL GUIDELINES
 Registration for Special Labs, NRLs, and Research/Teaching Labs (Certificate of Registration)
o registration form/necessary attachments submitted to BHFS or CHD (whichever is available)
o application fee for COR
o BHFS (evaluates the applications)
o BHFS will issue COR and CHD will
issue LTO
 Application for Initial/Renewal of LTO
o application form
o attachments/form to CHD (conducts
inspections)
 Renewal of LTO
o hospital-based: One-stop-shop
o non-hospital based: filing (Oct.-
Nov.)
o processing: not later than 5 days
after the expiration
 Inspection
o CHD: announced licensure
inspections (inspection tool will be
used)
o ensure accessibility and availability
of records
 Monitoring
o More frequent than the inspection
o BHFS or CHD: monitoring visits
 Notice of Violation
o CHD: submits a quarterly summary
of the violations to BHFS
o Health Offices: should report
unlicensed clinical labs
 SCHEDULE OF FEES
o non-refundable
o paid to DOH

VIOLATIONS
 refusal to participate in EQAP
 issuance of report not in accordance with documented procedures
 permitting unauthorized persons to perform procedures
 incompetence/consistent errors (habitual)
 deviation from standard test procedures
 reporting of erroneous results
 lending the name of a licensed lab to an unlicensed lab (sharing of licenses)
 unauthorized use of the name and signature of pathologist/MT to secure LTO
 reporting of results without performing the test
 transfer of results from an outside lab
 performing tests in which the lab is unlicensed to perform
 giving/receiving commission for patients referred to a clinical lab

INVESTIGATION OF COMPLAINTS

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LAB MANAGEMENT – LESSON 11 – LABORATORY LAWS AND REGULATIONS
 BHFS or the CHD Director: investigates the complaint
 CHD Director: shall suspend, revoke, or cancel LTO
 Penalty for operating an unlicensed lab:
o imprisonment of not less than 1 month
o fine: Php 1000-5000
o LTO will be revoked, cancelled, or suspended depending upon the investigation.
o Suspension is the lightest – if the offense is not that grave
 Appeal: to the DOH Sec. within 10 days
 Signatory: Sec. Francisco T. Duque
o Created: August 22, 2007