Chapter 8 Flashcards
POCT is also known as- (2)
-near patient testing
-decentralized testing
POCT is defined as-
lab assays performed near patient
POCT has a reduced-
turnaround time, but at a higher cost
Importance of decentralized Lab POCT Assays- (2)
-WHO identified 147 essential lab tests (EDLs)
-19 lab tests with highest number of applications to essential medicine have been ranked
WHO list of top 19 EDLs for application-
-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
advantages of POCT- (7)
-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
use of instruments with stable calibration curves is-
important
QC program should be available from-
manufacturer
all sites performing lab testing are regulated under-
CLIA 88 & must be licensed to perform any testing
CLIA has granted deemed status to approve-
accreditation organizations & allows these entities to accredit or license testing sites
states & city governments may enact mandatory regulations, including-
qualifications of personnel performing the tests, which may be more but not less stringent than federal regulations
POCT procedure categories- (4)
-waived test
-moderately complex tests
-highly complex tests
-provider performed microscopy
termed a waived test by TJC-
diagnostic testing not performed within a traditional lab
a site performing only waived tests must- (2)
-have a “certificate of waiver”
-adhere to manufacturers’ instructions for performing the test
all lab testing must meet the same quality standards regardless of-
where it is performed
for moderately complex POCT, in addition to requirements for waived tests instrument validation is required for-
each new instrument
control of POCT resides with-
CLIA certified lab
CLIA certified lab requires-
at least one lab staff member with credentials & on site to be responsible for each POCT program
written policies & procedures must be available for- (7)
-patient prep
-specimen collection & preservation
-QC & remedial actions
-instrument calibration
-test performance
-equipment performance evals
-results reporting & recording
in 2016, FDA published new final guidelines- (2)
-blood glucose monitoring test systems for prescription point of care use
-self monitoring blood glucose test systems for over the counter use
the FDA 2016 new final guidelines was the first time the performance guidelines clearly differentiated the requirements for-
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
US FDA approved marketing for-
23 & me personal genome service genetic health risk tests
approval of 23 & me is the first direct to consumer test that-
analyze DNA from users’ saliva to calculate their genetic predisposition for 10 different diseases/conditions
23 & me 10 different diseases/conditions-
-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
development of diagnostic testing readily available globally including-
resource-challenged settings
ultra-low cost diagnostics examples-
low-cost, easy-to-use diagnostic platform for detecting Zika virus
non automated POCT manual rapid test methods include- (3)
-pregnancy
-occult blood
-infectious mononucleosis
most non-instrumental-based tests apply the principles of- (3)
-competitive/non competitive immunoassay
-enzymatic assay
-chemical reactions with a visually read endpoint
non automated POCT assays usually assay- (5)
-whole blood
-urine
-feces
-saliva
-throat swabs
non instrument based POCT pregnancy test- (2)
-beta-human chorionic gonadotropin
-specimen collection
non instrument based POCT pregnancy test types-
enzyme immunoassays
non instrument based POCT fecal (stool) tests- (3)
-fecal occult blood tests (FOBT)
-fecal immunochemical test
-stool DNA test
types of FOBT- (3)
-chemical testing
-immunologic testing
-chemical vs. immunologic FOBT
fecal (stool) tests clinical significance-
fecal (stool) tests principle-
fecal (stool) tests specificity-
fecal (stool) tests interfering substances-
fecal (stool) tests dietary considerations-
guaiac slide tests for occult blood-
microprocessors in small & often handheld instruments provide-
automated, easy-to-perform testing with calibration & on-board QC
handheld POCT equipment uses- (2)
-small blood samples
-rapid turnaround time
handheld POCT equipment has easy portability with- (2)
-single use disposable reagent cartridges or test strips
-easy to perform protocol with 1-2 steps
handheld POCT equipment uses accuracy & precision of results compared with- (2)
-central lab analyzers
-minimal QC tracking & storage at ambient temps for reagents
handheld POCT equipment has barcode technology for- (3)
-test packs
-controls
-specimens
handheld POCT equipment has economical- (2)
-equipment cost
-maintenance free
handheld POCT equipment software for- (3)
-automatic calibration
-system lockouts
-data management
handheld POCT equipment has hard copy or electronic data output that interfaces with-
an LIS or other tracking software
handheld POCT equipment has higher costs-
per test
handheld POCT equipment errors from improper cleaning of devices between patients can produce- (2)
-higher error rate for POCT than central lab testing
-result in disease transmission to patients from the instruments
emerging patient centric technologies- (2)
-tricorder
-technology transfer
tricorder is a collection of non-invasive sensors custom designed to collect data about- (3)
-vital signs
-body chemistry
-biological functions
tricorders diagnostic engine synthesizes a patient’s health data to make-
quick & accurate assessment
the national air & space agency needs compact, reliable, lightweight diagnostics for monitoring-
crew health in space
a collaboration with DNA medicine institute has made a reusable microfluidic device that performs-
rapid, low-cost cell counts
a collaboration with DNA medicine institute has made a reusable microfluidic device that measures- (3)
-electrolytes
-proteins
-other biomarkers
microfluids channels are typically- (3)
-etched/molded into glass
-silicone
-plastic
Lab Info Management Systems (LIMS) represents transmission of-
sample centric info
Lab Info Management Systems (LIMS) represents transmission of sample centric info with the goal of-
providing timely, accurate info to clinicians
LIMS can routinely- (4)
-integrate automation & data handling
-provide uniform methodology with complete visibility
-lead to increased productivity
-process integrity
LIS is the tool for delivery of-
lab data
LIS is the integration of computers through a common database via-
various communication networks
technology driven enhancements in LIS include- (6)
-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
LIMS & LIS have converged-
somewhat in functionality
input devices- (2)
-monitors
-touch screens
barcodes- (2)
-one dimensional
-two dimensional
1D barcodes are-
linear
1D barcodes consist of-
series of parallel lines of varying widths that encode data
1D barcodes are read by-
laser optical device known as a scanner or reader
2D barcodes are _______ scannable-
omnidirectionally
radio frequency ID devices are an automatic ID method that-
stores & retrieves data using tags or transponders
output devices- (3)
-monitor
-printers
-on-board instrument displays
data storage devices- (4)
-hard drives
-optical storage disks (CDs/DVDs)
-solid state drives
-cloud storage
software-
encoded instructions for the operation of a computer
middleware connects- (2)
-software components
-applications
for interaction with users, LIS uses-
personal computers as work stations directly connected to the server for the LIS
interfacing-
exchange of info between the computer & the user
most labs connect work stations together using routers to form a local area network (LAN) that can access- (2)
-LIS server
-hospital information system (HIS)
a well-designed, easily accessible HIS-LIS database offers improvements in- (4)
-medical record keeping
-patient care planning
-budget planning
-general operations management tasks
for lab use, the interface specification should include- (4)
-what data will be transferred
-where data will be transferred
-when data will be transferred
-security/encryption considerations
a wide area network (WAN) connects-
multisite facilities into a single network
general functions of the lab info system can include- (7)
-patient ID
-patient demographics
-test ordering
-specimen collection
-specimen analysis
-test results
-test interpretation
pre analytical (pre exam) functions- (2)
-patient demographics
-test ordering
analytical (exam) functions- (2)
-molecular data
-genetic data
analytical (exam) functions auto verification-
computer based algorithms automatically perform actions on a defined subset of lab results without the need for manual intervention
post analytical (post exam) functions- (2)
-lab report
-critical patient results
benefits of automation- (6)
-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
automated systems include some type of device for-
sampling the patient’s specimen or other samples to be tested (blanks, controls & standard solutions)
automated systems includes a mechanism to add-
the specimen to reagents in the proper sequence
automated systems includes incubation modules when-
needed for the specific reaction
automated systems includes a measuring device such as photometric technology to-
quantitate the extent of the reaction
automated systems include recording mechanisms to provide the final-
reading or permanent record for the analytical result
major steps in automated analysis designed to mimic manual techniques- (5)
-specimen collection & processing
-specimen & reagent measurement & delivery
-chem reaction phase
-measurement phase
-signal processing & data handling
automated instruments have been designed to perform-
most frequently ordered tests
automated analyzers are desirable for-
less frequently ordered tests
initially, highly automated systems were introduced in- (2)
-larger volume clinical chemistry
-hematology labs
today, automation & semi-automation exists in other clinical lab sections of- (3)
-urinalysis
-blood bank
-micro
applicable info related to automation or semi-automation for each clinical specialty is included in-
specific clinical chapters
