External Quality Assessment
Performance Investigation Form
Laboratory result(s) reported by your laboratory for a recent proficiency testing survey were outside the acceptable limits.
Please review the survey results, answer the following questions and return the completed form to ALQEP:
Email:
Fax #:
[email protected]
(preferred)
(780) 428-2712
Mail:
College of Physicians & Surgeons of Alberta
2700, 10020 – 100 Street NW
Edmonton, AB T5J 0N3
Please call Ms. Liz McBride at (780) 969-5010 if you have any questions or concerns regarding the completion of this form.
1. Facility Information:
a.
ALQEP Facility #:
b.
Facility Name:
L
Zone:
** Select from the list **
2. General Survey Information:
a. External Quality Assessment Provider:
Clinical Microbiology Proficiency Testing Program (CMPT)
Other:
College of American Pathologists (CAP)
College of Physicians & Surgeons (CPSA)
b.
Survey Shipment date:
c.
3. Analyte/Result Information:
a.
Analyte/constituent/specimen source :
Select or enter only one per form;
Choose from the drop down lists,
OR Specify in the ‘All Others’ field
Survey ID/
Program Code :
Specify:
CAP
A–B
C–F
G–M
N–S
T–Z
Analytes :
--
--
--
--
--
All Others (please specify) :
b.
Challenge ID # (e.g. Sample B; M034-5; 04-12 B)
For more than 3, attach an additional page 1
c.
Unacceptable result value :
d.
Acceptable evaluation range/expected result:
Y
4. Unacceptable Result Investigation:
a.
Was the EQA survey report reviewed for discrepancies?
b.
Was the EQA testing material re-assayed/re-evaluated? Repeat value/assessment:
c.
Were problems with the survey material investigated (e. g. handling, reconstitution, storage, analysis sequence,
matrix effects, stain/preparation quality)?
d.
Were previous EQA challenge problems identified and investigated? (attach explanation)
e.
Was the method performance history reviewed (e. g. QC, maintenance, reagent/calibrator lot #’s, staff competency,
policy/procedure adherence)?
f.
Were appropriate reagents and controls used?
g.
Was equipment operated according to documented procedures?
h.
Was re-calibration of the method performed?
i.
Was the Instrument/kit manufacturer consulted?
j.
Was a reference or secondary method comparison completed?
N
N/A
Internal ALQEP use only:
cc:
ALQEP EQA Performance Investigation Form
© Copyright 2015 College of Physicians and Surgeons of Alberta
LAC:
Page 1 of 3
DOC:
SS:
CPSA: October 28, 2015
Replaces: August 7, 2008
5. Unacceptable Result Classification – Sources of Errors: Please check appropriate cause(s):
Laboratory/Internal:
a.
Clerical
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
Mislabelled vial or slide
Result not correctly transcribed to EQA report form
Incorrect units or misplaced decimal point
Incorrect instrument/method/reagent classification provided to EQA provider
Calculation/conversion error
Wrong or missing reporting code used
Missed reporting deadline
Other clerical problem unable to classify above (specify):
b.
Technical
Operation
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
xii.
xiii.
xiv.
xv.
Incorrect vial/sample assayed/evaluated
Improper mixing or handling of survey material
Pipetting/dilution error
EQA material improperly prepared (reconstitution) or stored
Expired kits or reagents used
Standards/reagents improperly reconstituted
Automated pipette incorrectly calibrated
Run acceptance in nonlinear range or when QC values were out of range
QC material outdated or improperly stored
Errors in result interpretation
Errors in interpretation of cell/organism morphology
Incorrect inoculum used
Written procedures not followed by analyst
Policy or procedure requires revision
Other technical problem unable to classify above (specify):
c.
Equipment /
Reagents
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
Problem with instrument data processing functions
Problem in manufacture of reagents/standards/kit (includes lot# problems)
Carry-over from previous specimen
Scheduled or preventative maintenance not performed or performed inappropriately
Insufficient sampling
Inappropriate identification of organism by system database
Failure of automated system to generate correct susceptibility test result
Equipment malfunction (e.g. obstruction of instrument tubing/orifice)
Other equipment problem unable to classify above (specify):
d.
Method
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
Incorrect calibration; Calibration issues/problems
Imprecision from result being too close to detection limit
Controls do not span detectable limits of test
Method inappropriate
Method lacks sensitivity
Stain lacks sensitivity
Method lacks specificity
Inappropriate incubation conditions
Other method problem unable to classify above (specify):
EQA Provider/External:
Provider
Issues
g. Random
e. Material Problems:
i.
Presence of interfering substances
ii.
Material deteriorated during transit
iii.
Bacterial contamination
iv.
Unstable survey material
v.
Inadequate sample (includes leakage problems)
vi.
Sample not viable
vii.
Matrix effect incompatible with method
viii.
Other material problems unable to classify (specify):
i.
f. Evaluation Issues:
i.
Peer group not appropriate
ii.
Target value not appropriate
iii.
Incorrect data entry by provider
iv.
Narrow range of acceptability
v.
No participant consensus
vi.
Incorrect method assigned
vii.
Other evaluation problems unable to classify
(specify):
Random event; investigation yielded no satisfactory explanation; unable to replicate error
ALQEP EQA Performance Investigation Form
© Copyright 2015 College of Physicians and Surgeons of Alberta
Page 2 of 3
CPSA: October 28, 2015
Replaces: August 7, 2008
6. Additional comments regarding your result assessment investigation as indicated on page 1:
(Attach supporting documents if appropriate)
7. Additional comments regarding source of error/classification as indicated on page 2:
(Attach supporting documents if appropriate)
8. Action taken as a result of investigation:
Reviewed by:
Laboratory Supervisor or designate (required)
Laboratory Director or designate (required)
Name:
Name:
Date:
Date:
Optional Reviewers:
Title:
Title:
Title:
Name:
Name:
Name:
Date:
Date:
Date:
Copied To:
Thank you for completing this performance investigation form. The information obtained from these forms will be
used to compile performance follow-up statistics for ALQEP stakeholders.
ALQEP EQA Performance Investigation Form
© Copyright 2015 College of Physicians and Surgeons of Alberta
Page 3 of 3
CPSA: October 28, 2015
Replaces: August 7, 2008