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PMLS FINALS > Lesson 8 - Nature of the Clinical Laboratory > Flashcards

Lesson 8 - Nature of the Clinical Laboratory Flashcards

1
Q

Essential component of health institutions

A

Clinical Laboratory

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2
Q

Focuses on clinical chemistry, immunohematology, and blood banking. Concerned in the diagnosis and treatment of diseases performed through laboratory testing of blood and other fluids.

A

Clinical Pathology

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3
Q

TAT

A

Turnaround time

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4
Q

Focuses on histopathology, immunohistopathology, cytology. Concerned with the diagnosis of diseases through microscopic examination of tissues and organs

A

Anatomic pathology

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5
Q

Clinical laboratory that operates within the premises or part of an institution such as an hospital, school, medical clinic for overseas workers and seafarers.

A

Institution-based

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6
Q

Most common example of institution-based laboratories

A

Hospital-based clinical laboratories

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7
Q

Not part of an established institution. Most common example is a free-standing out-patient clinical laboratory

A

Free-standing clinical laboratory

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8
Q

Owned wholly, or partially by national, or local government units. San Jose Lazaro and Jose R. Reyes Memorial Medical Center are examples.

A

Government-owned

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9
Q

Are owned, established, and operated by an individual, corporation, etc. Examples are St. Luke’s Medical Center, Makati Medical Center, and MCU-FDTMF Hospital

A

Privately-owned

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10
Q

Are licensed to perform basic, routine laboratory testing, namely, routine urinalysis, routine stool examination, routine hematology or complete blood count

A

Primary category (clinical laboratory)

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11
Q

Equipment requirements for Primary category clinical laboratory (3)

A
  • Microscopes
  • Centrifuge
  • Hematocrit centrifuge
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12
Q

Space requirement for Primary category clinical laboratory

A

10 sq. meters

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13
Q

Are licensed to perform lab tests done by the primary category clinical labs along with routine clinical chemistry tests

A

Secondary category (clinical laboratory)

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14
Q

Secondary category clinical laboratory routine clinical chemistry tests (6) (non-hospital-based)

A
  • blood glucose concentration
  • blood urea nitrogen
  • blood uric acid
  • blood creatinine
  • cholesterol determination
  • qualitative platelet count
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15
Q

Secondary category clinical laboratory (3) (hospital-based)

A
  • gram stain
  • KOH mount
  • crossmatching
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16
Q

Secondary category clinical laboratory space requirement

A

20 sq. meters

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17
Q

Secondary clinical laboratory equipment requirements (7)

A
  • microscope
  • centrifuge
  • hematocrit centrifuge
  • semi-automated chemistry analyzers
  • autoclave
  • incubator
  • oven
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18
Q

Are licensed to perform all the laboratory tests performed in the secondary category plus (1) immunology and serology; (2) microbiology, bacteriology, and mycology; (3) special clinical chemistry; (4) special hematology; (5) immunohematology and blood banking

A

Tertiary category (clinical laboratory)

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19
Q

Tertiary category clinical laboratory equipment requirements (3)

A

those seen in secondary category along with:
- automated chemistry analyzer
- biosafety cabinet class II
- serofuge

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20
Q

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

A

National Reference Laboratory

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21
Q

EQAP

A

External Quality Assurance Programs

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22
Q

Labs according to Institutional Characteristics (2)

A
  • institution-based
  • free-standing
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23
Q

Labs according to Service Capability (4)

A
  • primary category
  • secondary category
  • tertiary category
  • National Reference Laboratory
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24
Q

Labs according to Ownership (2)

A
  • government-owned
  • privately-owned
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25
Q

an act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the department of health, providing penalty for the violation thereof, and for other purposes

A

RA No. 4688

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26
Q

Labs according to Function (2)

A
  • clinical Pathology
  • anatomic pathology
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27
Q

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license annually at the office of the Secretary of Health: provided, that government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions of government regional or central laboratories

A

RA 4688 Section 1

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28
Q

It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually. No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician, as provided for in the preceding paragraph.

A

RA 4688 Section 2

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29
Q

The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.

A

RA 4688 Section 3

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30
Q

Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year, or by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court.

A

RA 4688 Section 4

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31
Q

If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof.

A

RA 4688 Section 5

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32
Q

The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act.

A

RA 4688 Section 6

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33
Q

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

A

RA 4688 Section 7

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34
Q

This Act shall take effect upon its approval.

A

RA 4688 Section 8

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35
Q

The year RA 4688 was approved

A

June 18, 1966

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36
Q

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

A

Administrative Order No. 59 s. 2001

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37
Q

In the Administrative Order No. 59 s. 2001’s Section 1: Title, The Administrative Order shall be known as the

A

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

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38
Q

BHFS

A

Bureau of Health Facilities and Services

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39
Q

This laboratory includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring

A

Clinical Pathology

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40
Q

This laboratory includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology.

A

Anatomic Pathology

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41
Q

A laboratory that operates within a hospital

A

Hospital-based laboratory

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42
Q

A laboratory that operates on its own

A

Non-hospital-based laboratory

43
Q

A clinical laboratory shall operate with a valid license issued by _____ based on compliance with the minimum licensing requirements

A

BHFS/CHD

44
Q

Application for renewal of license shall be filed within how many days

A

90 days before expiry date

45
Q

Schedule of application for Renewal of License for NCR

A

January to March

46
Q

Schedule of application for Renewal of License for 1,2,3 & CAR

A

February to April

47
Q

Schedule of application for Renewal of License for 4,5 & 6

A

March to May

48
Q

Schedule of application for Renewal of License for 7,8 & 9

A

April to June

49
Q

Schedule of application for Renewal of License for 10,11,12, CARAGA & ARMM

A

May to July

50
Q

A penalty of ______ for late renewal shall be charged in addition to the renewal fee for all categories if the application is filed during the next two (2) months after expiry date.

A

₱1000

51
Q

An application received more than two (2) months after expiry date shall be fined _______ for each month thereafter in addition to the P1,000.00 penalty.

A

₱100

52
Q

Clinical laboratories shall be inspected every

A

2 years or as necessary

53
Q

Any change affecting the substantial conditions of the license to operate a laboratory shall be reported within ____ days in writing by the person(s) concerned, to the BHFS/ CHD for notation and approval. Failure to do so will cause the revocation of the license of the clinical laboratory.

A

15 days

54
Q

Any person who operates a clinical laboratory without the proper license from the Department of Health shall upon conviction be subject to imprisonment for not less than _______ or a fine of _______

A

1 month but not more than 1 year

Not less than ₱1000 and not more than ₱5000 or both at the discretion of the court

55
Q

According to AO No. 59 s. 2001 Section 13: Effectivity, These rules and regulations shall take effect ____ days after its publication in the Official Gazette, or in a newspaper of general circulation.

A

15 days

56
Q

For hospital-based clinical laboratory, there shall be at least ______ per shift to cover the lab operation

A

One registered medical technologist

57
Q

All lab reports shall be kept on file for at least ___ year

A

One year

58
Q

What are the clinical laboratory personnel? (4)

A
  • pathologist
  • medical technologist/clinical laboratory scientist
  • medical technician
  • phlebotomist
59
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. In terms of the number of tests performed, this section is considered to be one of the busiest. In majority of tertiary-level clinical laboratories, this section is characterized as a state-of-the-art, fully automated facility.

A

Clinical Chemistry

60
Q

Are the two most common body fluids subjected for analyses in Clinical Chemistry

A

Blood and urine

61
Q

The tests performed in Clinical Chemistry are: (12)

A

For diagnosis of Diabetes
- Fasting blood sugar (FBS)
- Glycosylated hemoglobin (HbA1c)

Total cholesterol
- High Density Lipoprotein (HDL)
- Low Density Lipoprotein (LDL)

Diagnosis of cardiovascular diseases
- Triglycerides (TAG)

Diagnosis of diseases involving the kidney
- Blood Uric Acid (BUA)
- Blood Urea Nitrogen (BUN)
- Creatinine

  • Total Protein (TP)
  • Albumin
  • Electrolytes
  • Clinical enzymology
62
Q

In some laboratories, hormone in the blood and urine are also measured under

A

Endocrinology

63
Q

Thyroid hormone tests include: (3)

A
  • Thyroid-stimulating Hormone (TSH)
  • T3 (Triodothyronine)
  • T4 (Thyroxine)
64
Q

IQA

A

Internal Quality Assurance

65
Q

CQA

A

Continuous Quality Improvement

66
Q

NEQAP

A

National External Quality Assurance Program

67
Q

Microbiology is subdivided into: (4)

A
  • bacteriology
  • mycobacteriology
  • mycology
  • virology
68
Q

At present, the work in this section is more focused on the identification of bacteria and fungi on specimens received.

A

Microbiology

69
Q

Specimens usually received in Microbiology are: (5)

A
  • blood
  • body fluids
  • stool
  • tissue
  • swabs from different sites of the body
70
Q

Tests in Microbiology (3)

A
  • microscopic visualization of microorganisms after staining, isolation, and identification of bacteria and fungi using varied culture media and different biochemical tests
  • antigen typing
  • antibacterial susceptibility testing
71
Q

Activities performed in Microbiology (5)

A
  • preparation of culture media and stains
  • quality assurance and control
  • infection control
  • biosafety
  • proper waste disposal
72
Q

Looks into the identification of mycobacterium from the specimens submitted

A

Mycobacteriology

73
Q

This section deals with the enumeration of cells in the blood and other body fluids. Bone marrow examination using automated analyzers is also conducted in this section

A

Hematology and Coagulation Studies

74
Q

Examinations done at Hematology and Coagulation Studies (9)

A
  • complete blood count (CBC)
  • hemoglobin
  • hematocrit
  • WBC differential count
  • red cell morphology and cell indices
  • quantitative platelet count
  • total cell count and differential count
  • blood smear preparation
  • staining for other body fluids
75
Q

Focus on blood testing for the determination of various coagulation factors

A

Coagulation Studies

76
Q

There are two major areas in this section of the laboratory. The first area is allotted to routine and other special examinations of urine such as macroscopic examinations to determine color, transparency, specific gravity, and pH level, and microscopic examinations to detect presence of abnormal cells and/or parasites as well as to quantify red cells and WBC and other chemicals found in urine. Examination of other body fluids is also performed in this area. The second area is assigned to the examination of stool or routine fecalysis.

A

Clinical Microscopy

77
Q

What are the primary activities in Clinical Microscopy

A
  • detection and identification of parasitic worms and ova
78
Q

Two main activities performed in Blood Bank/Immunohematology

A
  • blood typing
  • compatibility testing
79
Q

Screening for all antibodies and identification of antibodies as well as the blood components used for transfusion are also conducted in this section. This section is considered as the most critical in the clinical laboratory.

A

Blood Bank/Immunohematology

80
Q

Analyses of serum antibodies in certain infectious agents (primarily viral agents) are performed in this section. Similar to Clinical Chemistry and Hematology sections, automated analyzers are commonly used in this section when performing different serological tests.

A

Immunology and Serology

81
Q

Examples of antibody screening tests (3)

A
  • hepatitis B profile tests
  • serological tests for syphilis
  • tests for hepatitis C and dengue fever
82
Q

Activities performed in Histopathology/Cytology (4)

A
  • tissue processing
  • cutting into sections
  • staining
  • preparation for microscopic examination by a pathologist
83
Q

It is 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. This is useful in the diagnosis of some types of cancers by detecting the presence of tumor-specific antigens, oncogenes, and tumor suppressor genes. It can also be used to assess the responses of patients to cancer therapy as well as diagnosis of certain neurodegenerative disorders.

A

Immunohistochemistry

84
Q

Primarily uses different enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic conditions/disease processes.

A

Molecular Biology and Biotechnology

85
Q

The most common technique currently in use in Molecular Biology and Biotechnology. This technique has contributed to scientific advancements in laboratory research and is useful for a number of clinical techniques such as screening genetic indicators of disease and diagnosis of cancer and infectious diseases.

A

Polymerase Chain Reaction (PCR)

86
Q

The three phases of Laboratory Testing Cycle are:

A
  • pre-analytic
  • analytic
  • post-analytic
87
Q

Encompasses all activities starting from a medical doctor writing a laboratory request up to the time (called the turnaround time [TAT]) the results are generated and become useful information for the treatment and management of patients.

A

Laboratory Testing Cycle

88
Q

This 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 phase

89
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

90
Q

Includes the transmission of test results to the medical doctor for interpretation, TAT, and application of doctor’s recommendations.

A

Post-analytic phase

91
Q

Variables that may cause errors in pre-analytic phase are (9)

A
  • physiologic factors
  • diet
  • medications
  • alcohol and caffeine intake
  • exercise
  • underlying disease conditions
  • identification of patients and labeling of specimens
  • anticoagulant used
  • volume of specimen collected vis-a-vis volume of anticoagulant
92
Q

Encompasses all activities performed by lab personnel to ensure reliability of test results

A

Quality Assurance (QA)

93
Q

Two major components of Quality Assurance

A
  • IQAS (Internal Quality Assurance System)
  • EQAS (External Quality Assurance System)
94
Q

Includes day-to-day activities that are undertaken in order to control factors or variables that may affect test results

A

IQAS

95
Q

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

A

EQAS

96
Q

NRL

A

National Reference Laboratories

97
Q

NKTI

A

National Kidney and Transplant Institute

98
Q

RITM

A

Research Institute of Tropical Medicine

99
Q

LCP

A

Lung Center of the Philippines

100
Q

EAMC

A

East Avenue Medical Center

101
Q

SACCL

A

San Lazaro Hospital STD-AIDS Cooperative Center Laboratory

102
Q

HCV

A

Hepatitis C Virus

103
Q

HBsAg

A

Hepatitis B surface antigen

PMLS FINALS (1 decks)

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