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Medical Technology Laws and Bioethics

RA 4688

CLINICAL LABORATORY LAW (RA 4688)


The Clinical Laboratory Law RA 4688 was approved on June 18, 1966. Promulgated for the purpose of preventing the
operation and maintenance of substandard, improperly managed and poorly equipped clinical laboratories.

The Implementing Guidelines:


1. Administrative Order No. 201, Series of 1973
2. Administrative Order No. 290, Series of 1976
3. Administrative Order No. 52, Series of 1983
4. Administrative Order No. 49-B, Series of 1988
5. Executive Order No. 102, Series of 1999
Redirecting the Functions & Operations of the DOH
6. Administrative Order No. 2001-0059
Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the
Philippines
7. Administrative Order No. 2007-0027
Revised Rules & Regulations Governing the Licensure and Regulation of Clinical Laboratories in the
Philippines

Administrative Order No. 2007-0027


Objective: Promulgated to prescribe a revised minimum standard for clinical laboratories

Scope & Coverage


Applies to all entities performing the activities and functions of clinical labs, excludes government laboratories doing laboratory
examinations limited to AFB microscopy, malaria screening and cervical cancer screening; declared as extension of a licensed
government clinical lab.

Acronyms & Definition of Terms:

BHFS - Bureau of Health Facilities & Services


CHD Center for Health Development
Critical Values panic values that needs for some corrective action
EQAP External Quality Assurance Program
Mobile Clinical Laboratory moves from testing site but affiliated with base lab
Satellite Testing Site any testing site that performs lab exams outside the physical confines of the base lab
NRL National Reference Laboratory; govt hospital lab designated by DOH and may or may not be a part of
general clinical lab

Confirmatory testing; surveillance; resolution of conflicting results; training; research; implementation of EQAS; evaluation of diagnostic
kits and reagents

POCT Point of Care Testing (at or near the site of the patient)
Routine Test basic, commonly requested tests
STAT (short turn-around time)Tests urgent tests and to be released within one hour after procedure

Classification of Laboratories

A. Classification by Ownership
Government
Private
B. Classification by Function
Clinical Pathology
Anatomic Pathology
C. Classification by Institutional Character
Institution-based
Freestanding

D. Classification by Service Capability

D.1 General Clinical Laboratory


1. Primary Category
Routine hematology (CBC) Hb, Hct, WBC & Diff. count
Qualitative Platelet Determination
Routine Urinalysis
Routine Fecalysis
Blood Typing (Hospital-based)

2. Secondary Category performs the primary lab services +
Routine Clinical Chemistry includes blood glucose, BUN, BUA, Creatinine & Total Cholesterol
Quantitative platelet determination
Cross matching (Hospital-based)
Gram staining (Hospital-based)
KOH (Hospital-based)

3. Tertiary Category - performs the Primary and Secondary lab services +
Special Chemistry
Special Hematology
Immunology/Serology
Microbiology (C/S)

4. Limited Service Capability (for institution based only) i.e. dialysis centers & social hygiene clinics

D.2. Special Clinical Laboratory


1. Offers highly specialized laboratory services that are usually not provided by a general clinical
laboratory
Assisted Reproduction Technology Labs
Molecular and Cellular Technology
Molecular Biology
Molecular Pathology
Forensic Pathology
2. Anatomic Pathology

License to Operate (LTO)


It is a Requirement to ALL Clinical laboratories (one year) should be renewed 90 days prior to actual expiration date in the
months of OCTOBER and NOVEMBER

For LTO (non-hospital based lab)


State the name of the laboratory, name of the owner/operator, the Head of the laboratory, service capability and the period of
validity. In addition for the requirements are the license number and some official and Non-transferable document. If there
are major changes as well. Include in the submission is the Headship, address and ownership

D. 3. Government hospital Laboratories doing routine procedures / simple assays


Malarial Screening
AFB stains
PAP smear
STI screening
Exemptions in Laboratories:
Those laboratories designed for Academic and Research Purposes
The laboratory within clinics (POL Physicians Office Laboratory)

Penalty for the Late Renewal


Fine of Php 1000.00
Plus 100.00 for each month

Laboratory Heads and Staff


1. Headed and managed by a pathologist
2. Adequate number registered medical technologists and other professionals

In Areas where Pathologists are NOT available


A license physician with 3 months training on clinical lab medicine, QC (quality control) and lab management approved by the
Board of Pathologists will act as can head of the Clinical Laboratory

Requirements Physical Facilities:


1. Well ventilated
2. Working area should be sufficient to accommodate
3. Adequate water supply

QUALITY ASSURANCE PROGRAM


1. Internal Quality Assurance program
2. External Quality Assurance Program

National Reference Laboratory (NRL)


The Laboratory in a government hospital which have been designated by DOH to provides special function such:
Confirmatory testing
Surveillance
Resolution of conflicts
Training and Research
Evaluation of Reagents
EQAP

External Quality Assessment Program


It is a requirement in the renewal of license based on the reports of the External quality control for the satisfactory
performance of the laboratory services.

NRL (National Reference Laboratory)


RITM Dengue, Influenza, TB and other Mycobacterium, Malaria and other parasites
San Lazaro Hospital AIDS/HIV, Hepatitis, Syphilis and other STI
East Avenue Medical Center environmental and occupational Health, Toxicology
NKTI Hematology
Lung Center - Biochemistry

Communication and Records


Laboratory results shall bear the name and signature of: a Pathologist and the Medical technologist
ALL laboratory records shall be kept on file for at least 1 year while anatomic and forensic pathology are (kept
permanently)

NO PERSON IN THE LAB SHALL ISSUE A REPORT ORALLY OR IN WRITING WITHOUT THE DIRECTIVE FROM THE
PATHOLOGIST OR HIS AUTHORIZED ASSOCIATE
Inspection/Inspector of a Clinical Laboratory
1. Director for Center for Health Development/BHFS
2. BHFS or the CHD Director or his authorized representative

General Laboratory Guidelines

The LTO shall be issued only to clinical labs that comply with standards and technical requirements formulated by the BHFS
Clinical labs operated and maintained for research and teaching purposes (exempted but needs to be registered w/ BHFS). The
Special clinical labs are required to register w/ BHFS w/o being licensed (if not subject to other AO), NRL-designated by DOH shall be
covered by license of the clinical lab of the hospital

Register only w/ BHFS if physically independent & duly accredited by international certifying body like. CDC (Center for
Disease Control) and WHO (World Health Organization), or local body recognized by DOH (Department of Health)

POL required of license if doing any or all of the ff:


1. Issue official lab results
2. Perform more than monitoring exams
3. Cater not only to physicians own patients

POCT (Point of Care Testing) Specific Guidelines


A. Standards
Human Resources
Equipment
Glassware, Reagents & Supplies
Administrative Policies & Procedures
Technical Procedures
Quality Assurance Program
Communication & Records
Physical facilities/ Work Envt
Referral of Examinations Outside of the Clinical Lab
B. License to Operate
Issued in the name of licensee and is non-transferrable
Valid for one year and expires on the date set forth by CHD
Capability to perform HIV testing and /or drinking water analysis shall be specifically indicated in the LTO
Mobile labs permitted to collect specimens only & operate w/n 100 kms radius from base lab
Any substantial changes shall be reported to CHD w/n 2 wks in writing

Procedural Guidelines:
1. Registration for Special Clinical Labs, NRL, Research & teaching Labs
2. Procedures for Application for Initial/Renewal of LTO
3. Renewal of LTO
Hospital-based processed under the One-Stop-Shop Licensure System for Hospitals
Non-hospital based beginning first day of October until end of November of current year (discount on renewal
fee)
Automatic cancellation of LTO
a. Failure to submit duly accomplished form
b. Non-Payment of proper fee on or before expiration date
4. Inspection
CHD shall conduct announced inspections at reasonable time using inspection tool
5. Monitoring
BHFS/CHD Director or rep shall monitor clinical labs
Notice of violation for non-compliant labs shall be issued immediately
CHD concerned shall submit quarterly summary of violations to BHFS
Provincial, City & Municipal Health Officers can report existence of unlicensed labs

Violations

1. Refusal on any clinical lab to participate in EQAP


2. Issuance of a report, orally or in writing (in whole or part thereof) which is not in accordance w/ documented procedures
3. Permitting unauthorized persons to perform technical procedures
4. Incompetence
5. Deviations from standard test procedures
6. Lending or using the name of licensed lab or head or RMT to an unlicensed lab
7. Unauthorized use of the name and signature of Pathologist and RMT to secure LTO
8. Reporting a test result for clinical specimens even if the test was not actually done
9. Transferring results of tests done in an outside lab to the result form of the referring lab
10. Performing and reporting tests in a specialty or subspecialty in which the lab is not licensed
11. Giving and receiving any commission, bonus or kickback or rebate or engaging in any split-free for referral to clinical labs
licensed by DOH

Investigation of Charges or Complaints

The BHFS/CHD Dir or rep shall investigate the complaint or the BHFS/CHD Dir or rep shall suspend, cancel or revoke & may
seek any law enforcement agency to execute the closure of any erring lab when necessary
Penalty
1. Imprisonment of not less than 1 month; or
2. Fine not less than Php1000 but no more than Php5000; or Both
3. If a corporation- managing head or owner is liable

Administrative Order No. 2007-0027 Appeal


Appeal to the Office of the Health Sec within 10 days after receipt of notice of decision
a. Decision is final & executory
Repealing Clause
Separability Clause
Effectivity

Technical Standards and Minimum Requirements

A. Staffing
1. Managed by licensed Physician certified by the Philippine Board of Pathology
If the licensed Physician certified by the Philippine Board of Pathology not available any physician w. 3
months training on clinical lab medicine, QC & management may manage a primary/secondary lab as
certified by BHFS
2. RMTs should be available at all times during operation hours
Hospital-based lab at least 1 RMT/shift
3. Staff development & CPE program instituted

B. Physical Facilities
1. Well-ventilated, adequately lighted, clean & safe
2. Work space requirements (at least)
Primary - 10 m2
Secondary - 20 m2
Tertiary - 60 m2
C. Glasswares/Reagents/Supplies
D. Waste Management

E. Quality Control Program

1. Internal Quality Control


2. External Quality Control

All labs shall participate in an EQAS (External Quality Assurance) given by designated NRL
Satisfactory performance rating is the criteria for renewal of license
Refusal to participate in EQAS-NRL is a basis for suspension/revocation of license
F. Reporting
1. Bear the name & signature of Pathologist & RMT (Registered Medical Technologists)
2. No report orally or in writing without directive from pathologist or associate except in emergency cases

G. Recording
1. All requests and reports of all specimens submitted and examined
2. Kept in file for at least 1 year
Anatomic and forensic pathology reports are kept permanently
H. Laboratory Fees

Equipment/Instruments
Primary Laboratory Secondary Laboratory Tertiary Laboaratory
Clinical centrifuge All those in 1 plus the ff: All those in 2 plus the ff:
Hemacytometer Refrigerator Incubator
Microhematocrit centrifuge Photometer or its equivalent Balance
Microscope with OIL Waterbath or its equivalent Rotator
Hemoglobinometer or equivalent Timer or its equivalent Serofuge or its equivalent

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