Corrective Action Documentation Form - Wp Engine Page 3

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2016 PROGRAM GUIDE
I
Proficiency Testing Service
I
AAB
INVESTIGATION CHECKLIST
This form is to be used as a guide to assist in investigating, documenting, and correcting proficiency test failure or unacceptable results.
Identify the reasons for failure or unacceptable results in proficiency testing and take appropriate corrective measure. Complete
Proficiency Testing Corrective Action Form and attach copies of all records reviewed to this form.
1)
SPECIMEN HANDLING
a)
Were proficiency test specimens checked for acceptability when received? (Review notes made at the time proficiency test
was received).
Y / N / NA
b)
Were the specimens handled properly? (Review instruction for specimen preparation).
Y / N / NA
2)
CLERICAL ERRORS
a)
Verify correct value was transcribed from instrument printout to report form, or that the correct response was entered from the
list of results.
Y / N / NA
b)
Verify that decimal point and units of measure were honored on the report form.
Y / N / NA
c)
Verify that the correct code from the instrument or reagent list was entered on the report form.
Y / N / NA
d)
Verify that the correct testing method information was provided.
Y / N / NA
e)
Verify that any calculations were performed correctly. (even if automated calculation)
Y / N / NA
f)
Check summary report to verify value on report form was honored by the PT service.
Y / N / NA
3)
QUALITY CONTROL
a)
Were quality control materials within the acceptable range on the date of PT testing?
(Verify the quality control acceptable range in use.)
Y / N / NA
b)
Any evidence of trends or shifts in the periods just before and just after PT was tested?
Y / N / NA
4)
CALIBRATION
a)
What was the date of the last calibration?
___/___/____
b)
How often is calibration to be performed?
___/___/____
c)
When was last calibration verification performed?
___/___/____
d)
Were any calibration problems noted?
Y / N / NA
5)
INSTRUMENT
a)
Were instrument parameters entered correctly?
Y / N / NA
b)
Was daily maintenance performed on the date of PT testing?
Y / N / NA
c)
Was special maintenance performed just prior to PT?
Y / N / NA
d)
Were instrument problems noted when PT was performed?
Y / N / NA
6)
REAGENTS
a)
Check reagent / instrument log for notation of recent problems.
Y / N / NA
b)
Check reconstitution instructions in package insert versus procedure -any changes?
Y / N / NA
c)
Verify that open stability of reagent was not exceeded by reviewing procedure with testing personnel.
Y / N / NA
7)
TESTING PERSONNEL
a)
Date of last competency assessment for testing personnel.
___/___/____
b)
Review assay procedure and proficiency test sample preparation instructions with testing personnel to ensure that instructions
were followed.
Y / N / NA
c)
Review with testing personnel how samples were loaded to rule out misidentification or transposition of samples.
Y / N / NA
d)
Was retraining of testing personnel required and if so is this completed?
Y / N / NA
8)
PROCEDURE
Review procedure versus manufacturer’s most current recommendation for any changes.
a)
Y / N / NA
b)
If retained frozen or refrigerated specimens were retested, were the results the same as those reported?
Y / N / NA
c)
Call instrument or reagent manufacturer for input if cause is not readily identified.
Y / N / NA
9)
INTERPRETATION ERRORS
a)
Was PT challenge beyond the scope and extent of the testing routinely performed in your lab?
Y / N / NA
b)
Has summary report been reviewed for an explanation of key features of the element presented in the photomicrographs
and/or pictures?
Y / N / NA
c)
Have textbook references been consulted for additional information?
Y / N / NA
d)
(Microbiology) Compare the test characteristics found in your laboratory with the characteristics of the
correct identification. Review your results and procedure for the key to distinguish the correct identification
from the incorrect identification.
Y / N / NA
67
2016 PROGRAM GUIDE | Proficiency Testing Service | AAB

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