Thank you- good reminder of what the true goals are.
Joelle Weaver MAOM, HTL (ASCP) QIHC > From: ibern...@uab.edu > To: trathbo...@somerset-healthcare.com; sm...@msn.com; > joellewea...@hotmail.com; amber.mcken...@gastrodocs.net; > ronald.hous...@nationwidechildrens.org; histonet@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 > ibern...@uab.edu > ian.bern...@comcast.net > > > > > > > > -----Original Message----- > From: histonet-boun...@lists.utsouthwestern.edu > [mailto:histonet-boun...@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-boun...@lists.utsouthwestern.edu > [mailto:histonet-boun...@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: joellewea...@hotmail.com > To: sm...@msn.com; amber.mcken...@gastrodocs.net; > ronald.hous...@nationwidechildrens.org; histonet@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: sm...@msn.com > > To: amber.mcken...@gastrodocs.net; > > ronald.hous...@nationwidechildrens.org; > > histonet@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.mcken...@gastrodocs.net > > > To: ronald.hous...@nationwidechildrens.org; > > > histonet@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-boun...@lists.utsouthwestern.edu > > > [mailto:histonet-boun...@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.hous...@nationwidechildrens.org<mailto:ronald.houston@nationw > > > idechildrens.org> > > > www.NationwideChildrens.org<http://www.nationwidechildrens.org/> > > > > > > "One person with passion is better than forty people merely interested." > > > ~ E.M. Forster > > > > > > _______________________________________________ > > > Histonet mailing list > > > Histonet@lists.utsouthwestern.edu > > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > > > > > _______________________________________________ > > > Histonet mailing list > > > Histonet@lists.utsouthwestern.edu > > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > > > _______________________________________________ > > Histonet mailing list > > Histonet@lists.utsouthwestern.edu > > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > _______________________________________________ > Histonet mailing list > Histonet@lists.utsouthwestern.edu > http://lists.utsouthwestern.edu/mailman/listinfo/histonet > > > _______________________________________________ > Histonet mailing list > Histonet@lists.utsouthwestern.edu > http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
