MOD 4 Flashcards
(Revised* Rules and Regulations Governing the Licensure and Regulation of
Clinical Laboratories in the Philippines)
DOH A.O. 2007-0027
DOH A.O. 2021-0037
A facility where tests are done on specimens from the human body
Clinical Laboratory
provide consultative advisory services covering all aspects of laboratory investigation
Clinical Laboratory
include areas that are involved in the collection, handling, and or preparation of specimens
Clinical Laboratory
The basic, commonly requested tests in the laboratory, the results of which are NOT REQUIRED to be released immediately upon completion.
Routine Testing
STAT abbreviation
Abbreviation for sta’tim (immediately)
-Tests done on urgent cases
-Within 1 hour
STAT Tests
Lundberg: “life-threatening”
-something is done promptly and for which some corrective
action could be undertaken
Critical Values
by the national government, a local government unit, any other political unit or any department, division, board or agency
Government Ownership
Owned, established, and operated by any individual, corporation, association, or organization
Private Ownership
Clinical Pathology Function Services
11
Clinical Chemistry
Hematology
Immunohematology
Microbiology
Immunology
Clinical Microscopy
Endocrinology
Molecular Biology
Cytogenetics
Toxicology
TDM and other similar disciplines
Anatomic Pathology Function Services7
Surgical Pathology
Immunohistopathology
Cytology
Autopsy
Forensic
Pathology
Molecular Pathology
laboratory that operates within the premises and as part of an institution
Institution Based
A laboratory that does not form part of any other institution
Freestanding
GENERAL CLINICAL LABORATORY
primary category per DOH Department Memorandum No. 148 s.2003
Minimum technical working area of 10 square meters
GENERAL CLINICAL LABORATORY
primary category tests
a. Routine Hematology
i. Hemoglobin Mass Concentration
ii. Erythrocyte Volume Fraction (Hematocrit)
iii. Leukocyte Number Concentration (WBC count)
iv. Leukocyte Type Number Fraction (Differential count)
b. Qualitative platelet determination
c. Routine urinalysis
d. Routine fecalysis
e. Blood typing (for hospital based laboratories)
GENERAL CLINICAL LABORATORY
secondary category per DOH Department Memorandum No. 148 s.2003
Minimum technical working area of 20 square meters (as per DM No. 148 s.2003)
GENERAL CLINICAL LABORATORY
secondary tests
a. Services offered by primary laboratory
b. Routine Chemistry
i. Blood glucose substance concentration
ii. Blood urea nitrogen concentration
iii. Blood uric acid substance concentration
iv. Blood creatinine concentration
v. Blood total cholesterol concentration
c. Quantitative platelet determination
d. For Hospital-based laboratories:
Cross-matching
Gram staining
KOH preparation
GENERAL CLINICAL LABORATORY
Tertiary Category
Minimum technical working area of 60 square meters (as per DM No. 148 s.2003)
GENERAL CLINICAL LABORATORY
Tertiary Category tests
a. Services offered by secondary laboratory
b. Special Chemistry
c. Special Hematology, including coagulation procedures
d. Immunology
e. Microbiology- Culture and Sensitivity (C&S):
Hospital based: Aerobic AND anaerobic C&S
Non-hospital based : Aerobic OR anaerobic C&S
Provides the laboratory tests required for a particular service in institutions
Examples: Labs in dialysis center and hygiene clinics
GENERAL CLINICAL LABORATORY
Limited Services Capability (For institution-based only)
Laboratory that offers highly specialized laboratory services
not provided by a general clinical lab
SPECIAL CLINICAL LABORATORY
SPECIAL CLINICAL LABORATORYv tests
a. Assisted reproduction technology laboratories
b. Molecular and cellular technology
c. Molecular Biology
d. Molecular Pathology
e. Forensic Pathology
f. Anatomic Pathology
laboratory designated by the DOH to provide special functions and services for specific disease areas
National Reference Laboratories (NRL)
Functions NRL
5
a. Provision of referral services
o Confirmatory testing
o Surveillance
o Resolution of conflicting results between or among laboratories
b. Training
c. Research
d. Evaluation of diagnostic kits and reagents
e. Implementation of *EQAP
-Program where participating laboratories are given unknown samples for analysis
-Quality of performance is evaluated through peer group analysis (pre-determined value or to the reference value generated by labs)
External Quality Assurance Program (EQAP) or National External Quality Assurance Scheme (NEQAS)
NRLs in the Philippines
6
- East Avenue Medical Center
- Lung Center of the Philippines
- San Lazaro Hospital STD AIDS Cooperative Center Laboratory (SLH SACCL)
- National Kidney & Transplant Institute
- Research Institute for Tropical Medicine (RITM)
- Philippine Heart Center
NRL for environmental, occupational health, toxicology and
micronutrient assay
East Avenue Medical Center
NRL for Clinical Chemistry
Lung Center of the Philippines
NRL for HIV/AIDS and other Sexually Transmitted Infections
San Lazaro Hospital STD AIDS Cooperative Center Laboratory (SLH SACCL)
NRL for Hematology, Immunohematology, Immunopathology, Automated Urinalysis, and Anatomic Pathology for Renal Diseases and other unassigned organ system diseases
National Kidney & Transplant Institute
NRL for Microbiology and Parasitology
Research Institute for Tropical Medicine (RITM)
NRL for dengue, influenza, enteroviruses, measles and other viral exanthems, polio, tuberculosis and other mycobacteria, bacterial enteric diseases, mycology, emerging diseases, malaria and other parasites
Research Institute for Tropical Medicine (RITM)-
confirmatory testing laboratory for blood donor units for the National Voluntary Blood Services Program
Research Institute for Tropical Medicine (RITM)
National External Quality Assurance for Bacteriology, Parasitology, and Mycobacteriology
Research Institute for Tropical Medicine (RITM)
recognized National Influenza Center
WHO World Health Organization
NRL for Anatomic Pathology for Cardiovascular Diseases
Philippine Heart Center
Accreditation for Medical Technology Training Laboratories (Based on CHED Memorandum Order No. 13 s.2017)
-DOH- licensed tertiary clinical laboratory and duly accredited by CHED
-space to accommodate both staff and interns (1 sq. meters per intern)
-MLS intern must render 32 hours per week of internship duties
How many hours an intern must render in 1 year
1664
office/ clinic wherein laboratory examinations are performed
required to secure a clinical laboratory license
The Physician’s Office Laboratory (POL)
when is POL required to secure clin lab license
Issue official laboratory results
Perform more than *monitoring examinations
Cater not only to the physician’s own patients
Tests done in series on patients as a guide for treatment or follow-up of their condition
Monitoring examinations:
under the administrative control of a licensed
laboratory, but performs outside the physical confines of that laboratory
SEPARATE LICENSE: outside the premises where the central laboratory is
Satellite Testing Site
from testing site to another testing site, or has a temporary testing location
Has a base laboratory
Only permitted to collect specimens
only within 100 km radius from its main laboratory
Mobile Clinical Laboratories
testing at or near the site of patient care
bedside testing, outpatient and home care
If conducted in a hospital: Required to be under the management and supervision of the licensed clinical laboratory
Point of Care Testing (POCT)
-Persons performing POCTs are called
-primary patient providers
operators
regulates the qualifications for health-care personnel authorized to perform POCT
CLIA ’88 Clinical Laboratory Improvement Amendments of 1988 (CLIA’88)
US amendment to their Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing
Clinical Laboratory Improvement Amendments of 1988 (CLIA’88)
-Considered simple to perform and interpret
-The likelihood of erroneous results is negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly
-Require no special training or educational background
-Require only minimum quality control
Waived tests
Original eight waived tests (NOW 80)
o Blood glucose
o Reagent strip or tablet reagent urinalysis
o Erythrocyte sedimentation rate (nonautomated)
o Fecal occult blood
o Hemoglobin by copper sulfate (nonautomated)
o Ovulation tests
o Spun hematocrit
o Urine pregnancy tests
