MOD 4 Flashcards by Aubs Ganda

(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

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A facility where tests are done on specimens from the human body

Clinical Laboratory

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provide consultative advisory services covering all aspects of laboratory investigation

Clinical Laboratory

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include areas that are involved in the collection, handling, and or preparation of specimens

Clinical Laboratory

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The basic, commonly requested tests in the laboratory, the results of which are NOT REQUIRED to be released immediately upon completion.

Routine Testing

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STAT abbreviation

Abbreviation for sta’tim (immediately)

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-Tests done on urgent cases
-Within 1 hour

STAT Tests

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Lundberg: “life-threatening”
-something is done promptly and for which some corrective
action could be undertaken

Critical Values

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by the national government, a local government unit, any other political unit or any department, division, board or agency

Government Ownership

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Owned, established, and operated by any individual, corporation, association, or organization

Private Ownership

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Clinical Pathology Function Services
11

Clinical Chemistry
Hematology
Immunohematology
Microbiology
Immunology
Clinical Microscopy
Endocrinology
Molecular Biology
Cytogenetics
Toxicology
TDM and other similar disciplines

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Anatomic Pathology Function Services7

Surgical Pathology
Immunohistopathology
Cytology
Autopsy
Forensic
Pathology
Molecular Pathology

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laboratory that operates within the premises and as part of an institution

Institution Based

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A laboratory that does not form part of any other institution

Freestanding

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GENERAL CLINICAL LABORATORY
primary category per DOH Department Memorandum No. 148 s.2003

Minimum technical working area of 10 square meters

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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)

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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)

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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

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GENERAL CLINICAL LABORATORY
Tertiary Category

Minimum technical working area of 60 square meters (as per DM No. 148 s.2003)

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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

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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

1. East Avenue Medical Center 2. Lung Center of the Philippines 3. San Lazaro Hospital STD AIDS Cooperative Center Laboratory (SLH SACCL) 4. National Kidney & Transplant Institute 5. Research Institute for Tropical Medicine (RITM) 6. 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