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2.9 Repeat Analysis

2.9.1 Test Objective

Track the repeat and reject activity for the purpose of trend analysis. These analyses are to help maintain delivery of

consistent high quality clinical image data. This analysis should be performed on a quarterly basis.

2.9.2 Frequency

• QUARTERLY

For the repeat rates to be signicant, at least 250 patients must be tested.

2.9.3 Required Equipment

• Total Number of images acquired during the period

• Table RT-4a (Repeat/Reject Tracking)

2.9.4 Procedure

• Calculate the total number of repeated and rejected images for each reason code by adding each pertinent occur-

rence using the data from the RT-4a tables for the period.

• Calculate the repeated image total for the period by adding the individual repeat totals.

• Calculate the rejected image total in the same manner as the repeat totals using the individual reject totals.

• Calculate the Repeat Performance by dividing the repeated image total by the total number of images acquired

during the period.

• Calculate the Reject Performance by dividing the rejected image total by the total number of images acquired dur-

ing the period.

2.9.5 Performance Criteria and Corrective Action

Performance Criteria: Repeat Performance and Reject Performance should not change by more than two percent

from the previous period.

Corrective Action: Source of the change should be identied and evaluated to determine if improvement is possible.

The corrective action shall be taken within 30 days of the test date. Patient examination may continue during this pe-

riod.

HINT

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• During initial use while the total number of clinically acquired images are relatively low (below 200) these results can take

large changes as a result of the signicance of change concerning a single repeat or reject action.

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Konica Minolta CS-3 Quality Control Manual

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