Lesson 8 - Nature of the Clinical Laboratory Flashcards
1
Q
Essential component of health institutions
A
Clinical Laboratory
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
3
Q
TAT
A
Turnaround time
4
Q
Focuses on histopathology, immunohistopathology, cytology. Concerned with the diagnosis of diseases through microscopic examination of tissues and organs
A
Anatomic pathology
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
6
Q
Most common example of institution-based laboratories
A
Hospital-based clinical laboratories
7
Q
Not part of an established institution. Most common example is a free-standing out-patient clinical laboratory
A
Free-standing clinical laboratory
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
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
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)
11
Q
Equipment requirements for Primary category clinical laboratory (3)
A
- Microscopes
- Centrifuge
- Hematocrit centrifuge
12
Q
Space requirement for Primary category clinical laboratory
A
10 sq. meters
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)
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
15
Q
Secondary category clinical laboratory (3) (hospital-based)
A
- gram stain
- KOH mount
- crossmatching
16
Q
Secondary category clinical laboratory space requirement
A
20 sq. meters
17
Q
Secondary clinical laboratory equipment requirements (7)
A
- microscope
- centrifuge
- hematocrit centrifuge
- semi-automated chemistry analyzers
- autoclave
- incubator
- oven
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)
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
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
21
Q
EQAP
A
External Quality Assurance Programs
22
Q
Labs according to Institutional Characteristics (2)
A
- institution-based
- free-standing
23
Q
Labs according to Service Capability (4)
A
- primary category
- secondary category
- tertiary category
- National Reference Laboratory
24
Q
Labs according to Ownership (2)
A
- government-owned
- privately-owned
25
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
RA No. 4688
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Labs according to Function (2)
- clinical Pathology
- anatomic pathology
27
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
RA 4688 Section 1
28
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.
RA 4688 Section 2
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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.
RA 4688 Section 3
30
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.
RA 4688 Section 4
31
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.
RA 4688 Section 5
32
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.
RA 4688 Section 6
33
All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.
RA 4688 Section 7
34
This Act shall take effect upon its approval.
RA 4688 Section 8
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The year RA 4688 was approved
June 18, 1966
36
Rules and Regulation Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines
Administrative Order No. 59 s. 2001
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In the Administrative Order No. 59 s. 2001's Section 1: Title, The Administrative Order shall be known as the
Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines
38
BHFS
Bureau of Health Facilities and Services
39
This laboratory includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring
Clinical Pathology
40
This laboratory includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy and Forensic Pathology.
Anatomic Pathology
41
A laboratory that operates within a hospital
Hospital-based laboratory
42
A laboratory that operates on its own
Non-hospital-based laboratory
43
A clinical laboratory shall operate with a valid license issued by _____ based on compliance with the minimum licensing requirements
BHFS/CHD
44
Application for renewal of license shall be filed within how many days
90 days before expiry date
45
Schedule of application for Renewal of License for NCR
January to March
46
Schedule of application for Renewal of License for 1,2,3 & CAR
February to April
47
Schedule of application for Renewal of License for 4,5 & 6
March to May
48
Schedule of application for Renewal of License for 7,8 & 9
April to June
49
Schedule of application for Renewal of License for 10,11,12, CARAGA & ARMM
May to July
50
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.
₱1000
51
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.
₱100
52
Clinical laboratories shall be inspected every
2 years or as necessary
53
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.
15 days
54
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 _______
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
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.
15 days
56
For hospital-based clinical laboratory, there shall be at least ______ per shift to cover the lab operation
One registered medical technologist
57
All lab reports shall be kept on file for at least ___ year
One year
58
What are the clinical laboratory personnel? (4)
- pathologist
- medical technologist/clinical laboratory scientist
- medical technician
- phlebotomist
59
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.
Clinical Chemistry
60
Are the two most common body fluids subjected for analyses in Clinical Chemistry
Blood and urine
61
The tests performed in Clinical Chemistry are: (12)
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
In some laboratories, hormone in the blood and urine are also measured under
Endocrinology
63
Thyroid hormone tests include: (3)
- Thyroid-stimulating Hormone (TSH)
- T3 (Triodothyronine)
- T4 (Thyroxine)
64
IQA
Internal Quality Assurance
65
CQA
Continuous Quality Improvement
66
NEQAP
National External Quality Assurance Program
67
Microbiology is subdivided into: (4)
- bacteriology
- mycobacteriology
- mycology
- virology
68
At present, the work in this section is more focused on the identification of bacteria and fungi on specimens received.
Microbiology
69
Specimens usually received in Microbiology are: (5)
- blood
- body fluids
- stool
- tissue
- swabs from different sites of the body
70
Tests in Microbiology (3)
- 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
Activities performed in Microbiology (5)
- preparation of culture media and stains
- quality assurance and control
- infection control
- biosafety
- proper waste disposal
72
Looks into the identification of mycobacterium from the specimens submitted
Mycobacteriology
73
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
Hematology and Coagulation Studies
74
Examinations done at Hematology and Coagulation Studies (9)
- 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
Focus on blood testing for the determination of various coagulation factors
Coagulation Studies
76
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.
Clinical Microscopy
77
What are the primary activities in Clinical Microscopy
- detection and identification of parasitic worms and ova
78
Two main activities performed in Blood Bank/Immunohematology
- blood typing
- compatibility testing
79
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.
Blood Bank/Immunohematology
80
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.
Immunology and Serology
81
Examples of antibody screening tests (3)
- hepatitis B profile tests
- serological tests for syphilis
- tests for hepatitis C and dengue fever
82
Activities performed in Histopathology/Cytology (4)
- tissue processing
- cutting into sections
- staining
- preparation for microscopic examination by a pathologist
83
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.
Immunohistochemistry
84
Primarily uses different enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic conditions/disease processes.
Molecular Biology and Biotechnology
85
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.
Polymerase Chain Reaction (PCR)
86
The three phases of Laboratory Testing Cycle are:
- pre-analytic
- analytic
- post-analytic
87
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.
Laboratory Testing Cycle
88
This phase includes the receipt of the laboratory request, patient preparation, specimen collection, and proper transport and processing of specimen to the clinical laboratory.
Pre-analytic phase
89
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
Analytic phase
90
Includes the transmission of test results to the medical doctor for interpretation, TAT, and application of doctor's recommendations.
Post-analytic phase
91
Variables that may cause errors in pre-analytic phase are (9)
- 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
Encompasses all activities performed by lab personnel to ensure reliability of test results
Quality Assurance (QA)
93
Two major components of Quality Assurance
- IQAS (Internal Quality Assurance System)
- EQAS (External Quality Assurance System)
94
Includes day-to-day activities that are undertaken in order to control factors or variables that may affect test results
IQAS
95
Is a system for checking performance among clinical laboratories and is facilitated by designated external agencies
EQAS
96
NRL
National Reference Laboratories
97
NKTI
National Kidney and Transplant Institute
98
RITM
Research Institute of Tropical Medicine
99
LCP
Lung Center of the Philippines
100
EAMC
East Avenue Medical Center
101
SACCL
San Lazaro Hospital STD-AIDS Cooperative Center Laboratory
102
HCV
Hepatitis C Virus
103
HBsAg
Hepatitis B surface antigen
