[Histonet] RE: competency form- Inspector Perspective.

joelle weaver joelleweaver <@t> hotmail.com
Fri Apr 11 10:14:13 CDT 2014


Thank you- good reminder of what the true goals are.  




Joelle Weaver MAOM, HTL (ASCP) QIHC
 
> From: ibernard <@t> uab.edu
> To: trathborne <@t> somerset-healthcare.com; smah2 <@t> msn.com; joelleweaver <@t> hotmail.com; amber.mckenzie <@t> gastrodocs.net; ronald.houston <@t> nationwidechildrens.org; histonet <@t> lists.utsouthwestern.edu
> Subject: RE: [Histonet] RE: competency form- Inspector Perspective.
> Date: Thu, 10 Apr 2014 01:57:10 +0000
> 
> I recently had the great honor to serve as a CAP inspector in Arizona. The lab we inspected will be accredited.   
> 
> Lest we forget as inspectors or future inspectors, I hope the below perspective illuminates the purpose of the CAP inspection and helps preserve the integrity of the program if adhered to.
> 
> As inspectors, we are trained to be thorough but to  simultaneously use "objective judgment" i.e. " there may be several ways to meet the intent of the question" and that "we must review all pertinent documentation and then determine if the process meets the intent of the requirement".
> 
> Keeping in mind that the purpose of CAP inspection is not punitive but "quality laboratory improvement to fulfill the regulatory purpose of the inspection (CLIA)". Our focus should be, in the interest of time and  thoroughness "major compliance issue rather than nitpick". This helps us maintain "professionalism and  preserve the peer-review nature of the program".
> 
> So what is it that constitutes compliance? 
> Per CAP:
> "- One, that the laboratory has defined a policy, a procedure, or a plan "of the three P's" for how they are going to do things in the lab. 
>   - Secondly, actual practices that matches those three P's. 
>   - Finally, documentation to support the fact that practice has indeed matched policies and procedures."
> 
> So what is a deficiency? 
> 
> Per CAP:
> "A deficiency means that the lab did not meet the intent of the checklist item.  It's not the wording; it's not the specifics. It is the intent".  If any of the three above criteria are not yet met, we should cite a deficiency" We are admonished to remember that "there may be many ways to accomplish an objective. The lab may not do things exactly the way that your lab does, but may still be meeting the intent of the requirement(s). Citing a laboratory for "not doing it the way we do it" is a common inspector error."
> 
> Per CAP, partial compliance is the following:  "If there is partial compliance (e.g., some records are inconsistent, one bottle of reagent was not labeled completely, a few temperatures were not recorded, etc.), you must judge whether the degree of non-compliance is likely to have adverse effects on test accuracy, patient care, or worker safety. Also, determine if the lab staff was aware of the inconsistency and if corrective actions were performed. If adverse effects are likely or if there are definite patterns (e.g., missing temperatures only on weekends) without corrective actions" only then we must cite a deficiency.
> 
> Bottom-line, If you feel you were incorrectly cited since you met the intent of the question, you should  appeal to  CAP. It is an inspected lab's right.  If a phase 11  deficiency, submit your evidence of compliance and the Lab  Accreditation Committee will either overrule or sustain.  I suspect they will overrule.
> 
> Just saying, but based upon just what you described, it sounds like you all met the intent of the question.
> 
> MSgt Ian R Bernard, HT(ASCP), MSHA-UAB
> Anatomic Pathology Lab Manager
> USAF- Active Duty
> ibernard <@t> uab.edu
> ian.bernard <@t> comcast.net
> 
> 
> 
> 
> 
> 
> 
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rathborne, Toni
> Sent: Wednesday, April 09, 2014 7:04 AM
> To: 'Sheila Haas'; joelle weaver; Amber McKenzie; Houston, Ronald; Histonet
> Subject: RE: [Histonet] RE: competency form
> 
> CAP inspectors may have opinions which differ from our own, and their interpretation of standards may also be different. Have you challenged this deficiency with CAP? 
> 
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Sheila Haas
> Sent: Wednesday, April 09, 2014 8:52 AM
> To: joelle weaver; Amber McKenzie; Houston, Ronald; Histonet
> Subject: RE: [Histonet] RE: competency form
> 
> What we had here, which did not meet the CAP inspectors requirements apparently, were the procedure (of course); a form with each observation of each task documented along with any corrective action necessary; the correlation of proficiency tests, educational assessments  and performance reviews for technical staff; daily evaluations from the pathologists concerning staining, microtomy and grossing; and educational training documentation. We had no idea with all pieces of this documentation that we were anticipated to have more. The form for DO of each task was not detailed enough (despite listing each task and proficiency or corrective action of each task) according to the inspectors. I was hoping someone could share a form so as to assist us in seeing what holes there are in our form. While this DO form is definitely not our only form, the inspectors specifically commented on this one.
>  
> If anyone can assist, it would be helpful.
> Thank you,
> Sheila Haas
> MicroPath Laboratories, Inc.
> Quality Assurance Coordinator
> 
>  
> From: joelleweaver <@t> hotmail.com
> To: smah2 <@t> msn.com; amber.mckenzie <@t> gastrodocs.net; ronald.houston <@t> nationwidechildrens.org; histonet <@t> lists.utsouthwestern.edu
> Subject: RE: [Histonet] RE: competency form
> Date: Wed, 9 Apr 2014 12:26:47 +0000
> 
> 
> 
> 
>  
> Is the question that Ronnie posed yesterday requesting justification of the need and extent of competency documentation for histology, or is it just a form needed? The general checklist pretty much sums up the necessity for doing, and required elements to me- GEN. 55500 and CLIA. Maybe I am not understanding?
> As for a form, I would expect that the specific items on any forms will vary by your personnel and by the testing and processes you perform. 
> What I did to document initial training and competency was a make a summary checklist for each "bench" with tasks and direct observations "DO" for initial training  & documentation of satisfactory performance before patient testing.
> I just put all those checklists together in a summary table for each person. High complexity; such as grossing, IHC, FISH scoring get more attention and documentation, the waived tests, you have more discretion,- but I thought it easier to do everything about the same. I have not been inspected on this document yet ( so can't say if CAP will have issues with it- but will know soon...) but here is basically what I did to meet GEN.55500 or the main parts; 
>  
>  
> Defined how competency is monitored- method and frequency ( just included as part of the competency SOP) Orientation and initial training documentation in a checklist for general lab, safety Training checklist on each technical bench, instrument, major procedure PT records and performance/results
> DO- a practical assessment ( block, slides, stains),  for the assessment of previously analyzed specimens, and a PI feedback checklist for the technical from this audit of issues- how/what to improve Check off in performing QC, calibration, patient ID procedures ( acceptable error rates), examples for file DO of grossing, other performance such as instrument programming/maintenance Written quiz, policies & procedures, troubleshooting( problem solving documentation) Continuing education participation records
> 
> 
> 
> 
> 
> Joelle Weaver MAOM, HTL (ASCP) QIHC
>  
> > From: smah2 <@t> msn.com
> > To: amber.mckenzie <@t> gastrodocs.net;
> > ronald.houston <@t> nationwidechildrens.org;
> > histonet <@t> lists.utsouthwestern.edu
> > Date: Wed, 9 Apr 2014 11:10:18 +0000
> > Subject: RE: [Histonet] RE: competency form
> > CC: 
> > 
> > We were recently dinged by CAP for our competency assessments in all areas. While that's no longer my immediate responsibility, I would love to be able to assist the lab manager with some information so we can tweek our assessments if you all wouldn't mind sharing with me as well.
> > Thanks a bunch.
> > Sheila Haas
> > MicroPath Laboratories, Inc.
> > Quality Assurance Coordinator
> >  
> > > From: amber.mckenzie <@t> gastrodocs.net
> > > To: Ronald.Houston <@t> nationwidechildrens.org;
> > > histonet <@t> lists.utsouthwestern.edu
> > > Date: Tue, 8 Apr 2014 21:17:44 +0000
> > > CC: 
> > > Subject: [Histonet] RE: competency form
> > > 
> > > Can you pass it on to me as well?  I'd love to compare what I've got to what someone else is doing. 
> > > Thanks,
> > > Amber
> > > 
> > > -----Original Message-----
> > > From: histonet-bounces <@t> lists.utsouthwestern.edu
> > > [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of 
> > > Houston, Ronald
> > > Sent: Tuesday, April 08, 2014 2:37 PM
> > > To: Histonet
> > > Subject: [Histonet] competency form
> > > 
> > > Can someone please share the competency form(s) they are using to satisfy CAP?
> > > 
> > > I am having problems convincing our QA/Compliance folks of the 
> > > differences between testing in AP compared to the other lab 
> > > disciplines, who do read our test results
> > > 
> > > Thanks
> > > 
> > > Ronnie Houston, MS HT(ASCP)QIHC
> > > Anatomic Pathology Manager
> > > ChildLab, a Division of Nationwide Children's Hospital 
> > > www.childlab.com
> > > 
> > > 700 Children's Drive
> > > Columbus, OH 43205
> > > (P) 614-722-5450
> > > (F) 614-722-2899
> > > ronald.houston <@t> nationwidechildrens.org<mailto:ronald.houston <@t> nationw
> > > idechildrens.org>
> > > www.NationwideChildrens.org<http://www.nationwidechildrens.org/>
> > > 
> > > "One person with passion is better than forty people merely interested."
> > > ~ E.M. Forster
> > > 
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