[Histonet] downloads available on these questions RE: Let's Talk CAP Inspections

Tue Aug 28 10:46:32 CDT 2012

You can download a powerpoint I made for validation presentations at NSH and ASCP meetings. Part of that presentation covers the issues mentioned below on how to relate regulations written primarily for analytical clinical labs to the histo and IHC labs.

This is a Yahoo group. Join for free and download the presentation "ASCP 2011 IHC QC Oct 20 2011 v10212011.pdf" (and you won't get any emails from me about the group. It is just a convenient download site).

http://pets.groups.yahoo.com/group/histoinfo/files/

There are several other files there as well, mostly concerning IHC validation, including extensive references.

Tim Morken
Supervisor, Electron Microscopy/Neuromuscular Special Studies
Department of Pathology
UC San Francisco Medical Center
505 Parnassus Ave, Box 1656
Room S570
San Francisco, CA 94143

(415) 353-1266 (ph)
(415) 514-3403 (fax)
tim.morken <@t> ucsfmedctr.org

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Matthew Chase
Sent: Tuesday, August 28, 2012 6:44 AM
To: 'Ian R Bernard'; histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: Let's Talk CAP Inspections

We just received the "All Common Checklist" all the questions from COM 40300 Analytic Accuracy/Precision to the end seem to be something for the clinical lab. How are some of you dealing with the following questions?

COM.40300       Analytic Accuracy/Precision     Phase II
        The laboratory verifies or establishes analytic accuracy and precision for each test.
NOTE:  Where current technology permits, accuracy is established by comparing results to a definitive or reference method, or may be verified by comparing results to an established comparative method.  Use of reference materials or other materials with known concentrations or activities is suggested in establishing or verifying accuracy.  Precision is established by repeat measurement of samples at varying concentrations or activities within-run and between-run over a period of time.
Evidence of Compliance:
✓       Written procedure for determining method performance characteristics, including accuracy/precision AND
✓       Records of verification or establishment of analytic accuracy and precision for each test

COM.40400       Analytic Sensitivity    Phase II
        The laboratory verifies or establishes the analytic sensitivity (lower detection limit) of each assay, as applicable.
NOTE:  For FDA-cleared/approved tests, documentation may consist of data from manufacturers or the published literature.
Evidence of Compliance:
✓       Written procedure for determining method performance characteristics, including analytic sensitivity AND
✓       Records of verification or establishment of analytic sensitivity for each assay

COM.40500       Analytic Interferences  Phase II
        The laboratory verifies or establishes analytic interferences for each test.
NOTE:  Interfering substances may pose a significant problem to the clinical laboratory and healthcare providers who may be misled by laboratory results that do not reflect patient clinical status.  The laboratory must be aware of common interferences by performing studies or having available studies performed elsewhere (such as by the instrument-reagent manufacturer).
Evidence of Compliance:
✓       Written procedure for determining method performance characteristics, including analytic interferences AND
✓       Records of verification or establishment of analytic interferences for each test

COM.40600       Reportable Range        Phase II
        The reportable range (analytic measurement range) is verified/established for each analytic procedure before implementation.
NOTE:  The analytic measurement range (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution or concentration.
Expanded definitions and details of the AMR are provided in some of the section-specific checklists (e.g. Chemistry).  Verification of the AMR may not apply to certain assays (for example, in immunology and coagulation).
The limits of the AMR are based on meeting accuracy and precision requirements such as the minimal limit of quantification or sensitivity, when applicable.  In some cases, clinically relevant limits may be narrower than the potential analytical range, and the clinically relevant limit would be used as the limit of the reportable range.
Evidence of Compliance:
✓       Written policy for determining method performance characteristics, including reportable range AND
✓       Records of verification or establishment of reportable ranges for each test

COM.40700       Method Performance Specifications Availability  Phase II
        The laboratory's current test methods, including performance specifications and supporting validation data (analytic accuracy, precision, analytic sensitivity, interferences, reference range, and reportable range, as acceptable), are available to clients of the laboratory and to the inspection team upon request.
NOTE: The laboratory must also provide data on clinical validity, if available, to clients upon request.
The CAP inspection team is instructed to use the validation data solely for accreditation purposes.
The laboratory may at its option require clients to agree to treat validation data as confidential and not to share such data with any other party except as required by law.

COM.40800       Analytic Methodology Changes    Phase II
        If the laboratory changes its analytic methodology so that test results or their interpretations may be SIGNIFICANTLY different, the change is explained to clients.
NOTE:  This requirement can be accomplished in any of several different ways, depending on local circumstances.  Some methods include directed mailings, laboratory newsletters or part of the test report itself.
Evidence of Compliance:
✓       Records such as directed mailings, laboratory newsletters or comment on the patient report advising of the change

COM.50000       Reference Intervals     Phase II
        The laboratory establishes or verifies its reference intervals (normal values).
NOTE:  Reference intervals are important to allow a clinician to assess patient results against an appropriate population.  The reference range must be established or verified for each analyte and specimen source (e.g. blood, urine, cerebrospinal fluid), when appropriate.  For many analytes (e.g. therapeutic drugs and CSF total protein), literature references or a manufacturer's package insert information may be appropriate.
Evidence of Compliance:
✓       Record of reference range study OR records of verification of manufacturer's stated range when reference range study is not practical (e.g. unavailable normal population) OR other methods approved by the laboratory director

COM.50100       Reference Interval Evaluation   Phase II
        The laboratory evaluates the appropriateness of its reference intervals and takes corrective action if necessary.
NOTE:  Criteria for evaluation of reference intervals include:

1.      Introduction of a new analyte to the test repertoire
2.      Change of analytic methodology
3.      Change in patient population
If it is determined that the range is no longer appropriate for the patient population, corrective action must be taken.
Evidence of Compliance:
✓       Records of evaluation and corrective action, if indicated

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Ian R Bernard
Sent: Tuesday, August 28, 2012 6:44 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Let's Talk CAP Inspections

I trust all of us will hopefully benefit from this line of discussion:

In 2013 our lab will undergo our 2013 CAP inspection. The Cyto (Non-Gyn)-pathology, and Anatomic(Surgical only) Pathology and now the new "Commons" checklist will be used.

Over the next weeks, in an effort to prepare, and to get feedback to CAP questions that tend to be subject-to-interpretation or subjective (since inspectors are our peers) versus objective questions (that are straight forward (or "elementary my dear friend"), I will present questions with hopes of obtaining interpretations from you, my fellow subject matter experts and fellow inspectors.

By the way, this will be my first CAP inspection as sole manager of our lab.

I also think volunteering to serve as an inspector will help the process as well. Look out, I may be coming your way.

IB

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Tom McNemar
Sent: Tuesday, August 28, 2012 4:37 AM
To: 'angela smith'; histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] Remote processor alarms

We are tied into the main lab system. It is a wireless system from Rees Scientific.  We have the VIP 5 and it monitors the voltage.  I get a call if there is an error of any type.

Tom McNemar, HT(ASCP)
Histology Co-ordinator
Licking Memorial Health Systems
(740) 348-4163
(740) 348-4166
tmcnemar <@t> lmhealth.org
www.LMHealth.org

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of angela smith
Sent: Monday, August 27, 2012 4:53 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Remote processor alarms

What kind of remote alarms do you all have on your various processors when something goes wrong when you are not open but have processors running. So far I found sensaphone for the Peloris. I am interested in all types.
Thank you
Angela Smith
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