Final Test Flashcards
Who owns the software associated with LIS?
- Laboratory
- Analyzer manufacturer
- Other companies who create and sell LIS software
What is included in patient database management?
- Collection of patient info
- card readers can ‘swipe’ patients health card to load info onto computer
- reporting physician info
- patient history to compare results
- tests entered into system and corresponding barcodes are printed containing a variety of patient and test info
What does LIS do in relation to quality control?
Storage of results
- evaluation of results against predetermined set of values and flags abnormalities
- some calculations, calibration curves, graphing
- even QC done through LIS must be accepted by MLT
How does LIS interact with analyzers?
- capacity for auto verification where LIS compares results to predetermined numbers and flags abnormal results for MLT evaluation (possible redo of test)
- results then verified and sent directly to patient database
How does LIS relate to the printing of reports?
Some labs have auto fax system that will give Doctor results immediately
STAT testing can be programmed and results flagged for calls from staff
What are the advantages and disadvantages of point of care testing?
Pros- less sample needed, faster
Cons- no QA or QC
It is MLA job to provide required QC training for POC tests
What is the Laboratory Information System used for?
- Manage their patient database
- manage their quality control info
- interface between analyzers and data bases
- print out reports or send them electronically
- connect between laboratory sites
What are som examples of point of care testing?
Glucose testing Pregnancy testing Analysis for strep throat Urinalysis Occult blood testing
What is total quality management?
Determines quality of both quantitative and qualitative processes
5 components: Quality lab processes Quality assurance Quality improvement Quality planning Quality control
What are some examples of quality lab processes?
Staff training-
- job specific
- WHMIS
- TDG
- legislation
Service contracts
- biohazard collection
- chemical collection
- instrument repair
- lab coats
Procedure manuals
- production and updating of manuals
- procedures strictly followed
What is quality assurance?
Assessing qualitative procedures using KEY INDICATORS by assessing individual steps of a process
Broken into 3 parts
What are the three parts of quality assurance?
Pre analytical
Analytical procedures
Post-analytical procedures
What is the purpose of key indicators?
To find errors and determine why they occurred
Find potential areas of weakness/improvement (linked to QI)
Meet accreditation standards
What are some pre analytical quality assurance examples?
Specimen collectiona(patient ID, data entry, data collection, specimen collection, collection instructions)
Specimen handling-(labelling, aliquoting, storage prior to testing, delivery to testing- correct temp etc)
Transportation-(delivery to correct site, proper packaging, correct storage)
What are some of the analytical components of quality assurance?
Reagent preparation
Instrument maintenance
Correct sample placed in analyzer
Control runs and control interpretation (qualitative)
Repeat tests if required
What are some post analytical components of quality assurance?
Test results transcribed/ reported with no typos
CORRECT normal ranges are applied to the test
Stat/urgent results faxed as requested
Results sent to correct place
What is an example of a preanalytical, analytical, and post analytical key indicator?
Preanalytical: Design an audit of samples that have been aliquoted- checking to make sure no errors. Calculate error %
Analytical: design an audit to determine if all samples requiring repeats are actually repeated. Calculate error -%
post analytical: design an audit to check transcription of test results
What is quality improvement?
1-Analysis of key indicator data: analyzed regularly to detect areas of improvement by determining error rates and looking for root causes
2- annual procedure manual review: review of processes and procedures by employees to remind of correct practices (identification of non compliance and evaluation of need for update)
What is quality planning?
Planning and implementing improvements using Quality assurance and Quality Improvement processes
Looking ahead at potential improvements
What is quality control?
Internal and external proficiency testing to see if it meets regulatory Criteria
What is the mathematical expression of precision?
SD and CV
Specificity
Ability to detect a SPECIFIC substance without interference from others
Calibration solution
- has one or more accurately known analytes
- basis for determining unknown values
Control
Solution that has one or more accurately known values
Used to verify ACCURACY and PRECISION
What is standard deviation?
A measure of spread in an array of data
Coefficient of variation
Measure of imprecision
Allowable limits of error
Maximum allowable deviation from mean or target value for each test (Max 95% of 2SD)
What are levy-Jennings charts used for?
Used to display quality control data
What are the two types of quality control material?
Commercial- purchased, used specifically for piece of equipment
In house-run with commercial control, then at regular intervals to ensure valid results are still being produced
What are he quality control materials for coagulation labs?
3 levels of commercial control
- abnormally high
- normal
- therapeutic
Run daily at start of new shift/operator, or when reagents change
- commercial run with every batch , or pooled in house control
- no westgard rules- review if results beyond 2SD
What are the controls used in hematology labs?
3 levels -
Abnormally low
Normal
Abnormally high
- uses patient control at regular intervals ( first test after commercial controls)
- patients tested 1 at a time
No westgard rules. 2SD out of control
What are quality control mechanisms for chesty labs?
2 levels:
Normal
Abnormal
Both commercial and in house are run with every batch of patient samples
Westgard rules to determine whether in control or not
What are the 3 warning rules?
12S- one value beyond 2SD
41S- 4 consecutive values beyond 1SD
10x- 10 consecutive cakes fall on one side of mean
What are the 3 rejection rules?
22s- 2 consecutive values outside of 2SD
13S- 1 value exceeds 3 SD
r 45- range of 2 points greater than 4 SD
What is class A?
Compressed gas
What is class B?
Flammable and combustible materials
What is class C?
Oxidizing materials
What is class D?
Poisonous materials
What is class E?
Corrosive materials
What is class F?
Dangerously reactive
What is the consignor?
Person packaging goods
What is the consignee?
Person signing for package
What is the UN # for Class A?
2814
What is the UN # for class B?
3373
