Hi Angela,
For accreditation, we are supposed to do what we say and say what we do (in
our policies and procedures, P&Ps). So, I went to see what ours currently
say...
In our SPE P&P:
Quality Control
Quality control is run once per box of gel. Results of the control sample are
recorded in LIS.
In our IF P&P:
Quality Control
As directed by the Clinical Chemist responsible for interpretation and
validation of all SPE, UPE and IFE patterns, Quality control consists of: •
the delta check by the Clinical Chemist and technologist of the patient file
(paper record) of both regular and monoclonal proteins.
• Visual correlation of simultaneous protein patterns with Qigs
• Chemical (Modular) and electrophoretic albumin concentration correlations •
Quality and consistency is constantly reviewed visually by Clinical Chemist
NOTE: SPE and IFE protein investigations are only recommended for screening
and monitoring of monoclonal proteins
So, most of the things in the IF P&P could be added to the SPE P&P. The issue
is that QCing using a control without an (faint) M-Band does then not QC for
the purpose of the procedure, which is to detect M-Bands. Certainly when we
evaluate new SPE systems we challenge them in this fashion.
QCing using a normal control would QC for the quantitation of normal fraction
concentrations, and we do report these concentrations. However, I have noted
that the purchase QC material often has low Beta protein levels.
If the QC was considered as a "normal" control only...then, I would point out
that we have never had a gel with only monoclonol patients on it...there are
always normals on each gel of 30 lanes.
Another "QC" feature that we are fortunate to have, is that we rotate the
interpretations monthly between the 2 clinical chemists here, so for patients
with more than one sample, the previous (scans, IFs) come up to us in a file
(with all serum and urine results on that patient) for comparison...thus
standardizing and providing internal checking to some extent.
So, I have anticipated that question, but not sure we have the perfect answer
yet.
Looking forward to other comments,
Christine
> Dear all,
> We recently had a CPA inspection and one of our non-conformances was the
lack of internal QC for the quantitation of paraproteins by
> electrophoresis.
> I would be interested to hear what (?if) other labs have in place. Happy to
summarise any responses I get.
> Thanks in anticipation
> Angela
> Angela Kremmyda
> Senior Biochemist
> Dept of Clinical Biochemistry
> Royal Shrewsbury Hospital
> Mytton Oak Road
> Shrewsbury
> SY3 8XQ
> Tel: 01743 261158
> Fax: 01743 261159
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Christine Collier, PhD FCACB,
Service Chief, Clinical Chemistry,
Kingston General Hospital
Associate Professor, Queen's University
Phone: 613-549-6666 ext 4137
FAX results: 613-548-2429
FAX general: 613-548-6076
Pager: 613-536-7571
Cell: 613-541-8055
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