CAP Accreditation Requirements–Paraphrased
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Requirement:
Document validation of new reagent lots or shipments of reagents.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
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Requirement:
Document calibration or recalibration when controls fail to meet established criteria.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
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Requirement:
Use data to make changes to improve performance and patient safety.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Chart
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Requirement:
For quantitative tests, document use of control materials at more than one concentration (level) at least daily.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Chart
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Requirement:
For numeric QC data, document calculation of QC statistics at specified intervals to define analytic imprecision.
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- Intralaboratory Reports and Charts:
Summary Data Report
- Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Demonstrate that QC and instrument maintenance are performed and evaluated.
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Requirement:
Document verification results of controls for acceptability before reporting patient test results.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
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Requirement:
For hematology, document testing of two different stabilized control specimens and record results during each 24 hours of analyzer use.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Chart
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Requirement:
If commercially assayed controls are used for hematology instruments, verify the target values (mean and QC ranges).
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- Intralaboratory Reports and Charts:
Operator Report
- Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Laboratory Histogram Report
Statistical Profile Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
If unassayed controls are used in hematology, establish a statistically valid target mean and range for each lot by repetitive analysis.
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- Intralaboratory Reports and Charts:
Operator Report
- Unity™ Interlaboratory Reports:
Laboratory Comparison Report
Laboratory Histogram Report
Statistical Profile Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Fully define and document tolerance limits (numeric and nonnumeric) for all hematology and coagulation control procedures.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Chart
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Requirement:
Monitor precision data for significant changes.
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- Intralaboratory Reports and Charts:
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Histogram Report
Bias and Imprecision Histogram
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Document review and assessment of quality control data at least monthly.
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- Intralaboratory Reports and Charts:
Summary Data Report
Supervisor's Report
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Verify manufacturer's calibrations with control materials appropriate for the system.
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- Intralaboratory Reports and Charts:
Data Review Report
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Requirement:
Document that the photo-optical coagulation testing system (for PT, aPTT, and so on) is checked with two different levels of control material during each eight hours of patient testing and each time there is a change in reagents.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
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Requirement:
Document that the manual coagulation system is checked with two different levels of control material in duplicate during each eight hours of patient testing and each time there is a change of reagents.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
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Requirement:
Document ongoing evaluation of (QC) records, instrument maintenance and function, temperature, etc.
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Requirement:
Organize and present QC data so that it can be evaluated daily by the technical staff to detect problems, trends, etc.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Document that at least one quality control specimen for pH, pCO2, and pO2 (tonometered sample or liquid control material) is tested at least every eight hours of operation when patient specimens are tested.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
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Requirement:
Document that control materials for pH, pCO2, and pO2 represent both high and low values on each day of patient testing.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
Levey-Jennings Chart
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Document that one sample of control material for pH, pCO2, and pO2 is included each time patient samples are tested, except for automated instruments that internally calibrate at least once every 30 minutes of use.
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- Intralaboratory Reports and Charts:
Point Data Report
Supervisor's Report
Data Review Report
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Requirement:
Document the review for acceptability of quality control results.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Laboratory Performance Overview
Bias and Imprecision Histogram
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Requirement:
Collect and analyze pertinent data to monitor and assess performance.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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Requirement:
Use data to identify unwanted trends.
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- Intralaboratory Reports and Charts:
Point Data Report
Summary Data Report
Supervisor's Report
Operator Report
Data Review Report
Levey-Jennings Chart
- Unity™ Interlaboratory Reports:
Monthly Evaluation Report
Data Rejection Report
Laboratory Performance Overview
Laboratory Comparison Report
Laboratory Histogram Report
Bias and Imprecision Histogram
Statistical Profile Report
Affiliated Data Exception Report
Affiliated Laboratory Comparison Report
- InstantQC™ Reports and Charts:
InstantQC™ Report
InstantQC™ Chart
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