Clinical Lab Law RA.4688 Flashcards
The central governmental agency authorized to regulate the operation and maintenance of lab
DOH
Formulate rules and regulations
The secretary of DOH through the director of BRL
Bureau of Research and Laboratory
The 1st implementing rules and regulation
AO 201 s. 1973
Redirecting the Functions & Operations of the DOH
EO 102 s. 1999
Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines
AO 59 s. 2001
Revised Rules & Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
AO 27 s. 2007
I. Rationale
The registration operation and maintenance of Clin. Lab. In the Phils.
Preventing substandard, Improperly managed and poorly equipped clinical laboratories
AO No. 0027 s. 2007
Objective
Promulgated to prescribe a revised minimum standard for clinical laboratories
AO No. 0027 s. 2007
III. 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
AO No. 0027 s. 2007
who intends to operate a clinical lab
Applicant
BHFS
Bureau of Health Facilities & Services
CHD
Center for Health Development
panic values that needs for some corrective action
Critical values
EQAP
External Quality Assurance Program
checklist used by regulatory officer
Inspection Tool
any corporate body organized for educational, medical, charitable or similar purpose
Institution
document issued by DOH to applicant upon compliance
License
whom the license is issued
Licensee
moves from testing site but affiliated with base lab
Mobile Clinical Laboratory
series of tests on patients
Monitoring Examinations
gov’t hospital lab designated by DOH and may or may not be a part of general clinical lab
National Reference Laboratory
Dengue, Influenza, TB and Malaria
NRL for confirmatory testing of blood units.
RITM Research Institute for Tropical Medicine
HIV/AIDS, Hepatitis, Syphilis and other Sexually Transmitted Infections (STls).
SLH San Lazaro Hospital
Toxicology and Micronutrient Assay
East Avenue Medical Center
Hematology / Immunohematology
NKTI National Kidney and Transplant Institute
Biochemistry
Lung Center of the Philippines
POL
Physician Office Laboratory
POCT
Point of Care Testing (at or near the site of the patient)
basic, commonly requested tests
Routine Test
– any testing site that performs lab exams outside the physical confines of the base lab
Satellite Testing Site
– urgent tests and to be released within one hour after procedure
STAT Tests
3 Classification of Laboratories
Classification by Ownership
Classification by Function
Classification by Institutional Character
CC, Hema, Micro-Para, Mycology, CM
Clinical Pathology
Includes surgical pathology, histochemistry, immunopathology, cytology and post-mortem examinations
Anatomic Pathology
Includes all medico-legal examinations
Forensic Pathology
Classification by Service Capability
Routine hematology (CBC) – Hb, Hct, WBC & Differential count Qualitative platelet determination Routine urinalysis Routine fecalysis Blood typing
- General Clinical Laboratory
Primary
primary lab services + Routine clinical chemistry – includes blood glucose, BUN, BUA, Crea & total cholesterol Quantitative platelet determination Cross matching Gram staining KOH
Secondary
secondary lab services + special chemistry special hematology immunology/serology Microbiology (C/S)
Tertiary
– i.e. dialysis centers & social hygiene clinics
Note: Labs can be permitted to offer other lab services provided they comply with reqt’s with respect to, staff, equipment, reagents and supplies and listed under its LTO
Limited Service Capability (for institution based only)
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 Anatomic Pathology
. Special Clinical Laboratory
exempted but needs to be registered w/ BHFS
Clinical labs operated and maintained for research and teaching purposes
are required to register w/ BHFS w/o being licensed (if not subject to other AO)
. Special clinical labs
designated by DOH shall be covered by license of the clinical lab of the hospital
NRL- (??)
– required of license if doing any or all of the ff:
Issue official lab results
Perform more than monitoring exams
Cater not only to physician’s own patients
POL
LTO
CHD
License to Operate
Center for Health Development
Non-infectious dry waste
black
Non-infectious wet waste
green
Infectious and pathological waste
yellow
chemical waste with heavy metals
yellow w/ black band
radioactive waste
orange
Pressurized containers and sharps
red
Work space reqt’s
1º
2º
3º
10 m2 20 m2 60 m2
Managed by licensed Physician certified by the Philippine Board of Pathology
Staffing
“Any clinical laboratory weather attached or unattached to a hospital or clinic performing not more than 800 examinations a month should have atleast one medical technologist
For every other additional 800 or fraction thereof, another medical technologist should be hired”
A.O. no 290 S. 1976 – Moraleta p. 64
