M5: CLINICAL LABORATORY

Question 1

the definition of terms is based on

Answer 1

DOH A.O 2006-0027

Question 2

Replacement for DOH AO 2007-0027
all requirements for lab/yearly guidelines

Answer 2

AO 2021-0037

Question 3

• facility where tests are done on specimens from the human body to obtain information about the health status of a patient
• consultative advisory services
• collection, handling, and or preparation of specimens

Answer 3

clinical laboratory

Question 4

basic commonly requested tests in the laboratory, the results if which are not required to be released immediately upon completion. usual procedures and systems

Answer 4

routine testing

Question 5

sta’tim (immediately)
- urgent cases, results released immediately within one hr of the procedure

Answer 5

STAT test

Question 6

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

Answer 6

critical values

Question 7

start of specimen collection to release

Answer 7

turn around time

Question 8

classification by ownership

Answer 8

government and private

Question 9

national gov/local gov/political unit

Answer 9

government

Question 10

individual/corporation/association/org

Answer 10

private

Question 11

clinical pathology includes

Answer 11

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

Question 12

anatomic pathology

Answer 12

Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic
Pathology, Molecular Pathology

Question 13

molecular pathology includes

Answer 13

histopathology, cytopathology, molecular pathology

Question 14

within premises as part of an institution (hospital/med clinic/school/med facility/birthing home/psychiatric fac/ drug rehab)

Answer 14

institution based

Question 15

does not form any other institution

Answer 15

freestanding

Question 16

primary category description and services

Answer 16

• min 10 square meters
  a routine hematology
  b qualitative platelet determination
  c routine urinalysis
  d routine fecalysis
  e blood typing

Question 17

secondary

Answer 17

• min of 20 square meters
  a servuces offered by primary
  b routine chemistry
  c quantitative plateley determination
  d hospital based - cross matching, gram staining, koh preparation

Question 18

tertiary

Answer 18

• min 60 square meters
  a services by secondary
  b special chemistry
  c special hematology
  d immunology
  e microbiology culture and sensitivity
  hospital based - aerobic and anaerobic cs
  non hospi tal- aerobic or anaerobic
  cs

Question 19

• provides the laboratory tests required for a particular service for institutions

Answer 19

limited services capability (institutional based)

Question 20

classification by service capabilities

Answer 20

general clinical laboratory
special clinical laboratory

Question 21

services offered by special clinical laboratory

Answer 21

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

Question 22

regulates qualifications for health-care personnel authorized to perform POCT
- US ammendment to their pub health services act in which congress revised the federal program for certification and oversight of clin lab testing

Answer 22

clinical laboratory amendments of 1988 (CLIA’88)

Question 23

• considered simple to perform and interpret
  likelihood of erroneous results is negligible, no reasonable risk of harm to the patient if the test is done incorrectly
• no special training/background
• 8 before 1988 but 80 today

Answer 23

waived tests

Question 24

original 8 waived tests

Answer 24

blood glucose
reagent strip or tablet reagent urinalysis
erythrocyte sedimentation rate
fecal occult blood
hemoglobin by copper sulfate
ovulation tests
spun hematocrit
urine pregnancy tests

Question 25

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

Answer 25

special clinical laboratory

Question 26

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

Answer 26

National Reference Laboratories (NRL)

Question 27

national reference laboratories function

Answer 27

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

Question 28

- Program where participating laboratories are given unknown samples for analysis. The said samples are to be tested via the laboratory’s usual processing and examination - Quality of performance is evaluated using closeness of results to the pre-determined value or to the reference value generated by the participating laboratories through peer group analysis

Answer 28

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

Question 29

- NRL for environmental, occupational health, toxicology and micronutrient assay

Answer 29

East Avenue Medical Center

Question 30

– NRL for Clinical Chemistry

Answer 30

Lung Center of the Philippines

Question 31

NRL for HIV/AIDS and other Sexually Transmitted Infections 4. National Kidney & Transplant Institute- NRL for Hem

Answer 31

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

Question 32

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

Answer 32

National Kidney & Transplant Institute-

Question 33

NRL for Microbiology and Parasitology • 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 • Also the confirmatory testing laboratory for blood donor units for the National Voluntary Blood Services Program • National External Quality Assurance for Bacteriology, Parasitology, and Mycobacteriology • WHO-recognized National Influenza Center

Answer 33

Research Institute for Tropical Medicine (RITM)

Question 34

– NRL for Anatomic Pathology for Cardiovascular Diseases

Answer 34

Philippine Heart Center

Question 35

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

Answer 35

- Shall be a DOH- licensed tertiary clinical laboratory and duly accredited by CHED for Medical Technology/ Medical Laboratory Science Training Program - Shall have adequate space to accommodate both staff and interns (1 sq. meters per intern) - MLS intern must render 32 hours per week of internship duties not exceeding a total of 1664 hours in 1 year

Question 36

total hours that an MLS intern must work

Answer 36

1664 hours/6 months

Question 37

An individual doctor’s office/ clinic wherein laboratory examinations are performed

Answer 37

The Physician’s Office Laboratory (POL)

Question 38

Required to secure a clinical laboratory license when it undertakes any or all of the following:

Answer 38

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

Question 39

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

Answer 39

Monitoring examinations

Question 40

- Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performs outside the physical confines of that laboratory - outside the premises where the central laboratory is situated shall be required to secure a separate license to operate

Answer 40

Satellite Testing Site

Question 41

- Laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location - Has a base laboratory and licensed as part of the base laboratory - Only permitted to collect specimens - Allowed to operate only within 100 km radius from its main laboratory

Answer 41

Mobile Clinical Laboratories

Question 42

- Diagnostic testing at or near the site of patient care rather than in the clinical laboratory - Includes bedside testing, outpatient and home care

Answer 42

Point of Care Testing (POCT)

Question 43

US amendment to their Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. o Two subsequent amendments were made after 1988. However, the law continues to be cited as CLIA ’88 as named in legislation.

Answer 43

Clinical Laboratory Improvement Amendments of 1988 (CLIA’88)

Question 44

o Considered simple to perform and interpret o The likelihood of erroneous results is negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly o Require no special training or educational background o Require only minimum quality control

Answer 44

waived tests

Question 45

point of care testing people are often called

Answer 45

operators