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Clinical Lab Science Lecture > Chapter 8 > Flashcards

Chapter 8 Flashcards

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1
Q

POCT is also known as- (2)

A

-near patient testing
-decentralized testing

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2
Q

POCT is defined as-

A

lab assays performed near patient

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3
Q

POCT has a reduced-

A

turnaround time, but at a higher cost

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4
Q

Importance of decentralized Lab POCT Assays- (2)

A

-WHO identified 147 essential lab tests (EDLs)
-19 lab tests with highest number of applications to essential medicine have been ranked

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5
Q

WHO list of top 19 EDLs for application-

A

-CBC
-liver enzymes
-renal function
microscopy
-urinalysis
-nucleic acid testing (micro)
-electrolytes
-micro culture & sensitivity
-glucose
-antigen testing in micro
-serology
-human chronic gonadotropin
-bacterial biochemical typing
-lipid panel
-CD4+ lymphocyte count
-blood gases
-coag testing
-hemoglobin A1C testing
-calcium

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6
Q

advantages of POCT- (7)

A

-patient convenience
-smaller blood specimen required
-faster turnaround time
-testing performed near patient
-reduction of length of hospital stay
-improved patient care management
-easy to operate equipment

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7
Q

use of instruments with stable calibration curves is-

A

important

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8
Q

QC program should be available from-

A

manufacturer

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9
Q

all sites performing lab testing are regulated under-

A

CLIA 88 & must be licensed to perform any testing

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10
Q

CLIA has granted deemed status to approve-

A

accreditation organizations & allows these entities to accredit or license testing sites

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11
Q

states & city governments may enact mandatory regulations, including-

A

qualifications of personnel performing the tests, which may be more but not less stringent than federal regulations

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12
Q

POCT procedure categories- (4)

A

-waived test
-moderately complex tests
-highly complex tests
-provider performed microscopy

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13
Q

termed a waived test by TJC-

A

diagnostic testing not performed within a traditional lab

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14
Q

a site performing only waived tests must- (2)

A

-have a “certificate of waiver”
-adhere to manufacturers’ instructions for performing the test

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15
Q

all lab testing must meet the same quality standards regardless of-

A

where it is performed

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16
Q

for moderately complex POCT, in addition to requirements for waived tests instrument validation is required for-

A

each new instrument

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17
Q

control of POCT resides with-

A

CLIA certified lab

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18
Q

CLIA certified lab requires-

A

at least one lab staff member with credentials & on site to be responsible for each POCT program

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19
Q

written policies & procedures must be available for- (7)

A

-patient prep
-specimen collection & preservation
-QC & remedial actions
-instrument calibration
-test performance
-equipment performance evals
-results reporting & recording

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20
Q

in 2016, FDA published new final guidelines- (2)

A

-blood glucose monitoring test systems for prescription point of care use
-self monitoring blood glucose test systems for over the counter use

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21
Q

the FDA 2016 new final guidelines was the first time the performance guidelines clearly differentiated the requirements for-

A

both types of CLIA waived devices self-monitoring blood glucose devices vs. blood glucose monitoring systems for professional/prescription use in a hospital or professional care setting

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22
Q

US FDA approved marketing for-

A

23 & me personal genome service genetic health risk tests

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23
Q

approval of 23 & me is the first direct to consumer test that-

A

analyze DNA from users’ saliva to calculate their genetic predisposition for 10 different diseases/conditions

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24
Q

23 & me 10 different diseases/conditions-

A

-alpha-1 antitrypsin deficiency
-celiac disease
-early onset primary dystonia
-factor XI deficiency
-gaucher disease type 1
-glucose 6 phosphate dehydrogenase deficiency
-hereditary hemochromatosis
-hereditary thrombophilia
-late onset alzheimer disease
-parkinson disease

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25
Q

development of diagnostic testing readily available globally including-

A

resource-challenged settings

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26
Q

ultra-low cost diagnostics examples-

A

low-cost, easy-to-use diagnostic platform for detecting Zika virus

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27
Q

non automated POCT manual rapid test methods include- (3)

A

-pregnancy
-occult blood
-infectious mononucleosis

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28
Q

most non-instrumental-based tests apply the principles of- (3)

A

-competitive/non competitive immunoassay
-enzymatic assay
-chemical reactions with a visually read endpoint

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29
Q

non automated POCT assays usually assay- (5)

A

-whole blood
-urine
-feces
-saliva
-throat swabs

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30
Q

non instrument based POCT pregnancy test- (2)

A

-beta-human chorionic gonadotropin
-specimen collection

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31
Q

non instrument based POCT pregnancy test types-

A

enzyme immunoassays

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32
Q

non instrument based POCT fecal (stool) tests- (3)

A

-fecal occult blood tests (FOBT)
-fecal immunochemical test
-stool DNA test

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33
Q

types of FOBT- (3)

A

-chemical testing
-immunologic testing
-chemical vs. immunologic FOBT

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34
Q

fecal (stool) tests clinical significance-

A
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35
Q

fecal (stool) tests principle-

A
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36
Q

fecal (stool) tests specificity-

A
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37
Q

fecal (stool) tests interfering substances-

A
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38
Q

fecal (stool) tests dietary considerations-

A
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39
Q

guaiac slide tests for occult blood-

A
40
Q

microprocessors in small & often handheld instruments provide-

A

automated, easy-to-perform testing with calibration & on-board QC

41
Q

handheld POCT equipment uses- (2)

A

-small blood samples
-rapid turnaround time

42
Q

handheld POCT equipment has easy portability with- (2)

A

-single use disposable reagent cartridges or test strips
-easy to perform protocol with 1-2 steps

43
Q

handheld POCT equipment uses accuracy & precision of results compared with- (2)

A

-central lab analyzers
-minimal QC tracking & storage at ambient temps for reagents

44
Q

handheld POCT equipment has barcode technology for- (3)

A

-test packs
-controls
-specimens

45
Q

handheld POCT equipment has economical- (2)

A

-equipment cost
-maintenance free

46
Q

handheld POCT equipment software for- (3)

A

-automatic calibration
-system lockouts
-data management

47
Q

handheld POCT equipment has hard copy or electronic data output that interfaces with-

A

an LIS or other tracking software

48
Q

handheld POCT equipment has higher costs-

A

per test

49
Q

handheld POCT equipment errors from improper cleaning of devices between patients can produce- (2)

A

-higher error rate for POCT than central lab testing
-result in disease transmission to patients from the instruments

50
Q

emerging patient centric technologies- (2)

A

-tricorder
-technology transfer

51
Q

tricorder is a collection of non-invasive sensors custom designed to collect data about- (3)

A

-vital signs
-body chemistry
-biological functions

52
Q

tricorders diagnostic engine synthesizes a patient’s health data to make-

A

quick & accurate assessment

53
Q

the national air & space agency needs compact, reliable, lightweight diagnostics for monitoring-

A

crew health in space

54
Q

a collaboration with DNA medicine institute has made a reusable microfluidic device that performs-

A

rapid, low-cost cell counts

55
Q

a collaboration with DNA medicine institute has made a reusable microfluidic device that measures- (3)

A

-electrolytes
-proteins
-other biomarkers

56
Q

microfluids channels are typically- (3)

A

-etched/molded into glass
-silicone
-plastic

57
Q

Lab Info Management Systems (LIMS) represents transmission of-

A

sample centric info

58
Q

Lab Info Management Systems (LIMS) represents transmission of sample centric info with the goal of-

A

providing timely, accurate info to clinicians

59
Q

LIMS can routinely- (4)

A

-integrate automation & data handling
-provide uniform methodology with complete visibility
-lead to increased productivity
-process integrity

60
Q

LIS is the tool for delivery of-

A

lab data

61
Q

LIS is the integration of computers through a common database via-

A

various communication networks

62
Q

technology driven enhancements in LIS include- (6)

A

-QC storage & functionality
-comprehensive analyzer interface support including calculations
-tools to aid in regulations compliance
-capability to share data with third parties
-automated result report dissemination to support workflow models
-rules based logic for decision making support

63
Q

LIMS & LIS have converged-

A

somewhat in functionality

64
Q

input devices- (2)

A

-monitors
-touch screens

65
Q

barcodes- (2)

A

-one dimensional
-two dimensional

66
Q

1D barcodes are-

A

linear

67
Q

1D barcodes consist of-

A

series of parallel lines of varying widths that encode data

68
Q

1D barcodes are read by-

A

laser optical device known as a scanner or reader

69
Q

2D barcodes are _______ scannable-

A

omnidirectionally

70
Q

radio frequency ID devices are an automatic ID method that-

A

stores & retrieves data using tags or transponders

71
Q

output devices- (3)

A

-monitor
-printers
-on-board instrument displays

72
Q

data storage devices- (4)

A

-hard drives
-optical storage disks (CDs/DVDs)
-solid state drives
-cloud storage

73
Q

software-

A

encoded instructions for the operation of a computer

74
Q

middleware connects- (2)

A

-software components
-applications

75
Q

for interaction with users, LIS uses-

A

personal computers as work stations directly connected to the server for the LIS

76
Q

interfacing-

A

exchange of info between the computer & the user

77
Q

most labs connect work stations together using routers to form a local area network (LAN) that can access- (2)

A

-LIS server
-hospital information system (HIS)

78
Q

a well-designed, easily accessible HIS-LIS database offers improvements in- (4)

A

-medical record keeping
-patient care planning
-budget planning
-general operations management tasks

79
Q

for lab use, the interface specification should include- (4)

A

-what data will be transferred
-where data will be transferred
-when data will be transferred
-security/encryption considerations

80
Q

a wide area network (WAN) connects-

A

multisite facilities into a single network

81
Q

general functions of the lab info system can include- (7)

A

-patient ID
-patient demographics
-test ordering
-specimen collection
-specimen analysis
-test results
-test interpretation

82
Q

pre analytical (pre exam) functions- (2)

A

-patient demographics
-test ordering

83
Q

analytical (exam) functions- (2)

A

-molecular data
-genetic data

84
Q

analytical (exam) functions auto verification-

A

computer based algorithms automatically perform actions on a defined subset of lab results without the need for manual intervention

85
Q

post analytical (post exam) functions- (2)

A

-lab report
-critical patient results

86
Q

benefits of automation- (6)

A

-reduce medical errors
-reduce specimen sample volume
-increased accuracy & precision
-improved safety for lab staff
-faster turnaround time of results
-partially alleviating the impending shortage of skilled lab staff

87
Q

automated systems include some type of device for-

A

sampling the patient’s specimen or other samples to be tested (blanks, controls & standard solutions)

88
Q

automated systems includes a mechanism to add-

A

the specimen to reagents in the proper sequence

89
Q

automated systems includes incubation modules when-

A

needed for the specific reaction

90
Q

automated systems includes a measuring device such as photometric technology to-

A

quantitate the extent of the reaction

91
Q

automated systems include recording mechanisms to provide the final-

A

reading or permanent record for the analytical result

92
Q

major steps in automated analysis designed to mimic manual techniques- (5)

A

-specimen collection & processing
-specimen & reagent measurement & delivery
-chem reaction phase
-measurement phase
-signal processing & data handling

93
Q

automated instruments have been designed to perform-

A

most frequently ordered tests

94
Q

automated analyzers are desirable for-

A

less frequently ordered tests

95
Q

initially, highly automated systems were introduced in- (2)

A

-larger volume clinical chemistry
-hematology labs

96
Q

today, automation & semi-automation exists in other clinical lab sections of- (3)

A

-urinalysis
-blood bank
-micro

97
Q

applicable info related to automation or semi-automation for each clinical specialty is included in-

A

specific clinical chapters

Clinical Lab Science Lecture (10 decks)

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