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MLSCI 330 - Hem > QC > Flashcards

QC Flashcards

1
Q

Quality Management

Organizational Level

A

Processes that affect the quality of laboratory test results
12 major components (QSE)

Update processes

SOP review

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2
Q

12 QSE

Quality Management

A

Quality Improvemt
Organization and Structure
Personnel Management
Information Management
Occurance Management
Process Control
Service and Satisfaction
Assessment
Documents and Records Management
Equipment Management
Purchasing and Inventory
Facilities and Safety

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3
Q

Quality Assurance

Management/Supervisor level

A

Activities implemented so quality requirements are fulfilled - ensures reliability of test results.
All activities related to specimen testing
Pre-analytical, Analytical, Post-analytical

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4
Q

Pre-analytical variables

A

Test ordering
Patient preparation and ID
Specimen collection
Transport of specimen
Handling of specimen before testing

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5
Q

Analytical variables

A

QC procedures for each test method
Use of QC samples along with pt samples

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6
Q

Post-analytical variables

A

Turn-around-time
Reporting of results

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7
Q

Quality Control

Individual Level

A

Monitoring of a test procedure
Ensures results are VALID, ACCURATE, PRECISE

Alerts technologist of a problem

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8
Q

Accuracy

Reliability

A

Closeness in which a result checks with the true value

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9
Q

4 assessments of Accuracy

A
  1. Running QC sample with known amount of substance - compared to true value
  2. Comparison of results from a reference method
  3. Comparison of results to reference laboratory
  4. Use of recoveries (not used in Hem) - known substance is added to a solution, ran, determine how much substance is recovered

Reference method - specific for analyte, accurate, gold standard

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10
Q

Precision

Reproducibility

A

Closeness of results between several repeats

Coefficient of Variation

Standard Deviation

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11
Q

Qualities of QC material

A
  1. Similar composition and form to unknown samples (whole blood)
  2. Analyzed in same manner as unknowns
  3. Stable (saves money and time)
  4. Known value established by manufacturer
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12
Q

When do you use Coefficient of Variation?

A

Comparison of two different assays
Test precision of tests with different concentration units
Methods with different means
Establish limits of allowable variation (at diff conc ranges)

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13
Q

Primary Standard

A

Reference material with known [analyte]
Used to calibrate instrument or prepare standard curves

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14
Q

Secondary Standard

A

Reference material [analyte] was determined by reference to primary method

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15
Q

Calibrator

A

Cell suspension with known parameters
Assigned value has been tested by multiple reference labs and reference methods

Cyan-methemoglobin standard

Adjust parameters on auto analyzer

Neither precision or accuracy - instrument adjustment

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16
Q

Westguard QC rules

A

12S - single control value +/-2SD (random, systmatic) WARNING RULE
22S - two consequtive control values outside +/-2SD (systematic) REJECTION RULE
13S - single control value is outside +/-3SD (random) REJECTION RULE
R4S - range between two control value within a run is >4SD; one exceeds +2SD while next exceeds -2SD (random) REJECTION RULE
41S - four consequtive control values exceed 1SD on same side (systematic) REJECTION RULE
10X - ten consequtive control values fall on same side of mean (systematic) REJECTION RULE

41S, 10X - trend is starting/established

17
Q

Systematic Error

A

Regular and deteminate (measurable)
Loss of accuracy
Change in mean (not SD)
Result in shifts/trends

18
Q

Contant systematic error

A

same direction, same magnitude

19
Q

Proportional systematic error

A

increase in magnitude and concentration of substance increases

20
Q

Sources of SYSTEMATIC ERROR

A

Change of reagent/calibrator lot number
Deteriorationg or imporoperly prepared reagents
Imporoper pipette calibration (alters sample volume)
Deterioration of light source (photometric)
Deterioration of QC material
Changed incubator temperature

21
Q

Random Errors

A

Accidental, indeterminate, lack defined pattern
Decrease precision, large SD

can be detected via Delta Checks

22
Q

Sources of RANDOM ERROR

A

Bubbles (reagent, line)
Inadequate mixing
Unstable temperature, electrical source
Individual operator variation (pipetting)

23
Q

Delta Check

A

Compares patient recent result with past one
> 30% change

Add comment to result
Recollection may be needed

24
Q

Bull’s Moving Averages

A

Detect/monitor instrument issues
Shift

25
Q

Bull’s Moving Averages Principle

A

RBC indices contant in a population
Data is compared between batches in a population

26
Q

Action with critical results

A

Review testing conditon
Previous criticals?
Sample integrity
- confirm result

Phone pt location/physician
-document phone call

MLSCI 330 - Hem (10 decks)

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