Clinical Laboratory Flashcards

1
Q

Is the place where specimens collected from individual are processed, analyzed, preserved, and properly disposed

A

Clinical laboratory

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2
Q

RA 4688 is aka

A

Clinical Laboratory Law

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3
Q

Classification of Clinical Laboratories

A

clinical pathology and anatomic pathology

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4
Q

Administrative Order no. 37 series of 2021 states that?

A

laboratories can be classified according to 3
classification of function (Clinical Pathology,
Anatomic Pathology and Molecular Pathology)

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5
Q

According to RA 4688 or the Clinical Laboratory Law, laboratories can be classified into two:

A

Clinical pathology, anatomic pathology

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6
Q

A clinical lab that focuses on the areas that is concerned with diagnosis of diseases through microscopic examination of tissues and organs

A

Anatomic pathology

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7
Q

It is concerned with the diagnosis and treatment of diseases performed through lab testing of body fluids

A

Clinical pathology

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8
Q
  • Analysis of genetic content and proteins
  • Other molecules in samples from
    organs, tissues or bodily fluids in
    order to diagnose disease and/or to
    guide the prevention and treatment
    of disease
A

Molecular Pathology

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9
Q

Classification of lab acc to institutional characteristics

A

Institution-based, free standing

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10
Q

Clinical lab that operates within the premises or part of an institution

A

Institution-based

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11
Q

Clinical lab that is not part of an established institution

A

Free-standing

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12
Q

Classification of clinical lab acc to Ownership

A

Government-owned and Privately-owned

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13
Q

Clinical lab that are owned, wholly or partially by national or local government units

A

Government-owned

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14
Q

Clinical lab are owned, established, and operated by an institution, corporation, organization, or association

A

Privately-owned

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15
Q

Classification of clinical lab acc to service capability

A

Primary category, secondary category, tertiary category, and national reference laboratory

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16
Q

Basic, routine lab testing
- routine urinalysis
- routine stool examination
- routine hematology or complete blood count

equipments:
Microscope
-Centrifuge
-Hematocrit centrifuge

A

Primary category

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17
Q

Licensed to perform lab tests being done by the primary category lab along with:
- routine chemistry tests
- cross matching

equipments:
- Microscopes
- Centrifuge
- Hematocrit centrifuge
- Semi-automated chemistry analyzers
- Autoclave (sterilize glasswares)
- Incubator

A

Secondary category

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18
Q

Gram stain is done in which type of lab?

A

Bacteriology

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19
Q

Are licensed to perform all the lab tests performd in the secondary category plus;
- immunology and serology (infection)
- microbiology, bacteriology, mycology
- special chemistry

A

Tertiary category

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20
Q

Minimum Floor requirement for primary, secondary, and tertiary category

A

Primary - 10 square meters
Secondary - 20
Tertiary - 60

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21
Q

Equipments include microscopes, centrifuge, hematocrit centrifuge are what type of category?

A

Primary category

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22
Q

Lab in a government hospital designated by the DOH to provide special diagnostic functions and services for certain diseases

A

National Reference Laboratory

23
Q

An act regulating the operation and maintenance of clinical lab and requiring th registration of the same with the department of health (DOH) providing penalty for the violation thereof, and for other purposes.

A

RA 4688

24
Q

● Section _ - Registration and Licensing
● Section 2- Lab should be headed by a duly
________ _________
● Section 3- Secretary of Health, through the Bureau of research and lab (RBL), now
____ -Issuance of rules and regulations
● Section 4- ______
- Imprisonment for not less than ONE MONTH but NOT MORE THAN ONE YEAR
- Fine of NOT LESS THAN 1K nor
MORETHAN5K
● Section 5- If any section or part of this Act
shall be adjusted by any court of competent
jurisdiction to be invalid, the judgment shall
not affect, impair or invalidate the remainder
thereof
Approval date: _______

A

1; REGISTERED PHYSICIAN; DOH; PUNISHMENT; June 18, 1966

25
Q

Rules and Regulation Governing the
Establishment, Operation and Maintenance
of Clinical Laboratories in the Philippines

A

ADMINISTRATIVE ORDER NO 59 S 2001

25
Q

An approved ______ to construct and Design layout of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a Petition to Operate

A

PERMIT

25
Q

A clinical Laboratory shall operate
with a valid ______ issued by
BHFS/Center Health Development
(CHD), based on compliance with
the minimum licensing requirements
(ANNEX A)

A

LICENSE

25
Q

Application for renewal of license shall be files WITHIN __ DAYS or ___ Months before the expiry date of the license described as follows:

A

90; 3

25
Q

Penalties
- ______ Pesos for late renewal
- ______ Pesos will be charged for an application received more than 2 months after expiry date

A

1K; 100

25
Q

Clinical Laboratory shall be inspected every ___ years or as necessary

A

2

25
Q

representative of any clinical desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in WRITING AT LEAST __ DAYS before the actual transfer

A

15

25
Q

An extension laboratory shall have a _____ LICENSE

A

separate

25
Q

The following acts committed by the Owner, President, Managers, Board of Trustees/Directors, Pathologist, or personnel are considered VIOLATIONS:

a. Operation of a clinical lab without a certified pathologist or without a ____
b. Change in location, ownership, head of the laboratory, or personnel without informing the BHFS and/or the CHD.
c. Refusal to allow inspection of the clinical lab by the person(s) authorized by the BHFS during reasonable hours.
d. Gross negligence.
e. Any act or omission detrimental to the public.

A

RMT

25
Q

The laboratory shall be managed by
a _______ _______ certified
by the Philippine Board of ______

A

LICENSED PHYSICIAN; PATHOLOGY

25
Q

At least __ RMT per shift to cover laboratory operations

A

1

25
Q

a. There shall be a documented, continuous competency assessment program for all laboratory personnel.
b. The program shall provide appropriate and standard laboratory methods, reagents, supplies, and equipment.
c. There shall be a program for the proper maintenance and monitoring of all equipment.
d. The program shall provide for the use of quality control reference materials

A

Internal quality control program

25
Q

a. All clinical laboratories shall participate in an External Quality Assurance Program provided by designated National Reference Laboratories and/or other recognized reference laboratories.
b. A satisfactory performance rating given by a National Reference Laboratory shall be one of the criteria for the renewal of the license.
c. Any refusal to participate in an External Quality Assurance Program given by the designated National Reference Laboratories shall be one of the bases for suspension/revocation of the laboratory’s license.

A

External Quality Control Program

25
Q

All laboratory reports on various examinations of specimens shall bear the name of the ______ and the _____ and duly signed by both.

A

RMT; Pathologist

25
Q

This section is intended for the testing of blood and other body fluids to quantify essential soluble chemicals, including waste products, useful for the diagnosis of certain diseases.

A

clinical chemistry

26
Q

This section deals with the enumeration of
cells in the blood and other body fluids

A

hematology

26
Q

focus on blood testing for the determination of various coagulation factors

A

coagulation studies

26
Q

CLINICAL MICROSCOPY

This section comprise two areas:
● ____ analysis and other body fluids (Physical exam, Chemical:Glucose, protein and bacteria, Microscopic)
● Examination of stool or routine _____

A

Urine, fecalysis

26
Q

Blood typing and compatibility testing are
the two main activities performed in this
section.

A

blood bank

26
Q

Screening for all ANTIBODIES and
identification of antibodies as well as. blood
components used for transfusion are also
conducted.

A

Immunohematology

26
Q

Analyses of SERUM ANTIBODIES in
certain infectious agents (primarily viral
agents) are performed in this section

A

serology

26
Q
  • a specialized section of the laboratory that combines anatomical, clinical, and biochemical techniques where antibodies (monoclonal and polyclonal) bounded to enzymes and fluorescent dyes are used to detect presence of antigens in tissue.
  • useful in the diagnosis of some types of cancers
A

IMMUNOHISTOCHEMISTRY

26
Q

Using different enzymes and other reagents, DNA and RNA are identified and sequenced to detect\ any pathologic conditions/disease processes. The most common technique currently in use is the ________

A

polymerase chain reaction

26
Q

________ phase includes the receipt of the laboratory request, patient preparation specimen collection, and proper transport and processing of specimen to the clinical laboratory.

A

pre-analytic

26
Q

deals with the actual testing of the
submitted/collected specimen. Important
consideration should be given to equipment and instruments used, reagents, and internal quality control program

A

analytic phase

26
Q

phase includes the transmission of test results to the medical doctor for interpretation, TAT, and application of doctor’s recommendations. The diagnosis and treatment are based on the generated data.

A

post-analytic

26
Q
  • Encompasses all activities performed by laboratory personnel to ensure reliability of test results.
  • It is organized, systematic, well planned and regularly done with the results properly
    documented and consistently reviewed
A

Quality Assurance

26
Q

includes day-to-day activities that are
undertaken in order to control factors or variables that may affect test results. Regular review and audit of results are done in order to identify weaknesses and consequently perform corrective actions

A

IQAS (Internal Quality Assurance System

26
Q

a system for checking performance among clinical laboratories and is facilitated by designated external agencies.

A

EQAS (External Quality Assurance System)

26
Q

The National Reference Laboratories (NRL) is the DOH-designated ____. An unknown sample with known test results is regularly sent to a clinical laboratory for testing

A

EQAS