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PMLS > MOD 4 > Flashcards

MOD 4 Flashcards

1
Q

(Revised* Rules and Regulations Governing the Licensure and Regulation of
Clinical Laboratories in the Philippines)

A

DOH A.O. 2007-0027
DOH A.O. 2021-0037

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2
Q

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

A

Clinical Laboratory

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3
Q

provide consultative advisory services covering all aspects of laboratory investigation

A

Clinical Laboratory

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4
Q

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

A

Clinical Laboratory

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5
Q

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

A

Routine Testing

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6
Q

STAT abbreviation

A

Abbreviation for sta’tim (immediately)

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7
Q

-Tests done on urgent cases
-Within 1 hour

A

STAT Tests

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8
Q

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

A

Critical Values

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9
Q

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

A

Government Ownership

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10
Q

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

A

Private Ownership

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11
Q

Clinical Pathology Function Services
11

A

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

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12
Q

Anatomic Pathology Function Services7

A

Surgical Pathology
Immunohistopathology
Cytology
Autopsy
Forensic
Pathology
Molecular Pathology

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13
Q

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

A

Institution Based

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14
Q

A laboratory that does not form part of any other institution

A

Freestanding

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15
Q

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

A

Minimum technical working area of 10 square meters

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16
Q

GENERAL CLINICAL LABORATORY
primary category tests

A

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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17
Q

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

A

Minimum technical working area of 20 square meters (as per DM No. 148 s.2003)

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18
Q

GENERAL CLINICAL LABORATORY
secondary tests

A

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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19
Q

GENERAL CLINICAL LABORATORY
Tertiary Category

A

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

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20
Q

GENERAL CLINICAL LABORATORY
Tertiary Category tests

A

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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21
Q

Provides the laboratory tests required for a particular service in institutions
Examples: Labs in dialysis center and hygiene clinics

A

GENERAL CLINICAL LABORATORY
Limited Services Capability (For institution-based only)

22
Q

Laboratory that offers highly specialized laboratory services
not provided by a general clinical lab

A

SPECIAL CLINICAL LABORATORY

23
Q

SPECIAL CLINICAL LABORATORYv tests

A

a. Assisted reproduction technology laboratories
b. Molecular and cellular technology
c. Molecular Biology
d. Molecular Pathology
e. Forensic Pathology
f. Anatomic Pathology

24
Q

laboratory designated by the DOH to provide special functions and services for specific disease areas

A

National Reference Laboratories (NRL)

25
Q

Functions NRL
5

A

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

26
Q

-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)

A

External Quality Assurance Program (EQAP) or National External Quality Assurance Scheme (NEQAS)

27
Q

NRLs in the Philippines
6

A
  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
28
Q

NRL for environmental, occupational health, toxicology and
micronutrient assay

A

East Avenue Medical Center

29
Q

NRL for Clinical Chemistry

A

Lung Center of the Philippines

30
Q

NRL for HIV/AIDS and other Sexually Transmitted Infections

A

San Lazaro Hospital STD AIDS Cooperative Center Laboratory (SLH SACCL)

31
Q

NRL for Hematology, Immunohematology, Immunopathology, Automated Urinalysis, and Anatomic Pathology for Renal Diseases and other unassigned organ system diseases

A

National Kidney & Transplant Institute

32
Q

NRL for Microbiology and Parasitology

A

Research Institute for Tropical Medicine (RITM)

33
Q

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

A

Research Institute for Tropical Medicine (RITM)-

34
Q

confirmatory testing laboratory for blood donor units for the National Voluntary Blood Services Program

A

Research Institute for Tropical Medicine (RITM)

35
Q

National External Quality Assurance for Bacteriology, Parasitology, and Mycobacteriology

A

Research Institute for Tropical Medicine (RITM)

36
Q

recognized National Influenza Center

A

WHO World Health Organization

37
Q

NRL for Anatomic Pathology for Cardiovascular Diseases

A

Philippine Heart Center

38
Q

Accreditation for Medical Technology Training Laboratories (Based on CHED Memorandum Order No. 13 s.2017)

A

-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

39
Q

How many hours an intern must render in 1 year

A

1664

40
Q

office/ clinic wherein laboratory examinations are performed
required to secure a clinical laboratory license

A

The Physician’s Office Laboratory (POL)

41
Q

when is POL required to secure clin lab license

A

Issue official laboratory results
Perform more than *monitoring examinations
Cater not only to the physician’s own patients

42
Q

Tests done in series on patients as a guide for treatment or follow-up of their condition

A

Monitoring examinations:

43
Q

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

A

Satellite Testing Site

44
Q

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

A

Mobile Clinical Laboratories

45
Q

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

A

Point of Care Testing (POCT)

46
Q

-Persons performing POCTs are called
-primary patient providers

A

operators

47
Q

regulates the qualifications for health-care personnel authorized to perform POCT

A

CLIA ’88 Clinical Laboratory Improvement Amendments of 1988 (CLIA’88)

48
Q

US amendment to their Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing

A

Clinical Laboratory Improvement Amendments of 1988 (CLIA’88)

49
Q

-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

A

Waived tests

50
Q

Original eight waived tests (NOW 80)

A

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

PMLS (4 decks)

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