[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 SensitivityPhase 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 RangePhase 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 ChangesPhase 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.5 Reference Intervals Phase II The laboratory establishes or verifies its reference intervals
RE: [Histonet] Special Stain documentation
We have this statement embedded into every report: Quality of hematoxylin and eosin staining was appropriate for slide evaluation. and if it's an immuno we have an auto text with the same type of wording. We first tried to get the pathologists to sign a log each day but that was a nightmare. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Weems, Joyce K. Sent: Monday, August 13, 2012 6:06 PM To: 'lau...@blufrogpath.com'; Histonet post Subject: RE: [Histonet] Special Stain documentation Our techs document that the controls work. My dream would be that the pathologist would document in the report with a phrase something like Controls stain appropriately. Joyce Weems Pathology Manager 678-843-7376 Phone 678-843-7831 Fax joyce.we...@emoryhealthcare.org www.saintjosephsatlanta.org 5665 Peachtree Dunwoody Road Atlanta, GA 30342 This e-mail, including any attachments is the property of Saint Joseph’s Hospital and is intended for the sole use of the intended recipient(s). It may contain information that is privileged and confidential. Any unauthorized review, use, disclosure, or distribution is prohibited. If you are not the intended recipient, please delete this message, and reply to the sender regarding the error in a separate email. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of lau...@blufrogpath.com Sent: Monday, August 13, 2012 5:35 PM To: Histonet post Subject: [Histonet] Special Stain documentation How do others document the results of routine special stain controls to be acceptable before reporting patient results (CAP checklist item ANP.21395)? Do the histotechs document the results or do the pathologists - or both?? If your pathologists document the results, how do they document them? Thanks, Laurie Colbert ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet This e-mail message (including any attachments) is for the sole use of the intended recipient(s) and may contain confidential and privileged information. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this message (including any attachments) is strictly prohibited. If you have received this message in error, please contact the sender by reply e-mail message and destroy all copies of the original message (including attachments). NOTICE: The information contained in this e-mail and any accompanying documents or files is intended for the sole use of the recipient to whom it is addressed, and may contain information that is privileged, confidential, and prohibited from disclosure under applicable law. If you are not the intended recipient, or authorized to receive this on behalf of the recipient, you are hereby notified that any review, use, disclosure, copying, or distribution is prohibited and possibly a violation of federal/state law or regulations. If you received this information in error, please notify The Children's Medical Center of Dayton immediately via telephone at (937) 641-5293, or via electronic mail cmcconfidential...@childrensdayton.org and promptly destroy the original message. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] RE: Assisting with Autopsies
We are small too, about 3-5 per year and that is one thing I hate...yes we do. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Amy Self Sent: Tuesday, July 19, 2011 3:12 PM To: 'histonet@lists.utsouthwestern.edu' Subject: [Histonet] Assisting with Autopsies Hello All, We are small hospital that does approximately 5-10 autopsies a year. This being said our administration department does not want to hire a diener to assist with these autopsies. So I have decided to turn to all of you out there in histoland for a little poll. Does your facility use histotechs or a diener to assist with the autopsy? Thanks in advance for all of your help, Amy Amy Self Georgetown Hospital System 843-527-7179 NOTE: The information contained in this message may be privileged, confidential and protected from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify us immediately by replying to this message and deleting it from your computer. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet NOTICE: The information contained in this e-mail and any accompanying documents or files is intended for the sole use of the recipient to whom it is addressed, and may contain information that is privileged, confidential, and prohibited from disclosure under applicable law. If you are not the intended recipient, or authorized to receive this on behalf of the recipient, you are hereby notified that any review, use, disclosure, copying, or distribution is prohibited and possibly a violation of federal/state law or regulations. If you received this information in error, please notify The Children's Medical Center of Dayton immediately via telephone at (937) 641-5293, or via electronic mail cmcconfidential...@childrensdayton.org and promptly destroy the original message. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Dayton Ohio Histotech Needed
Hey All A fulltime Histotech position is open at Dayton Children's Hospital in Dayton Ohio. We are a small hospital. We have one part time, one full time (that could be you) and myself. We process about 5000 cases a year, we average about 15-40 blocks a day. This is Dayton Children's Hospital, good benefits, not a whole lot of stress. If you're looking for a great place with a great group of people give me a call, or call HR at 937-641-8090 and ask for Dan Krauss. Or just apply online at http://www.childrensdayton.org/cms/careers/index.html If you want more specifics you can call me at 641-3000 ext 8229. Please no Headhunters, we are not allowed to use employment agencies, thanks. Matt Chase Supervisor of Pathology NOTICE: The information contained in this e-mail and any accompanying documents or files is intended for the sole use of the recipient to whom it is addressed, and may contain information that is privileged, confidential, and prohibited from disclosure under applicable law. If you are not the intended recipient, or authorized to receive this on behalf of the recipient, you are hereby notified that any review, use, disclosure, copying, or distribution is prohibited and possibly a violation of federal/state law or regulations. If you received this information in error, please notify The Children's Medical Center of Dayton immediately via telephone at (937) 641-5293, or via electronic mail cmcconfidential...@childrensdayton.org and promptly destroy the original message. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[Histonet] Dayton Ohio Position Open
Hey All A fulltime Histotech position is open at Dayton Children's Hospital in Dayton Ohio. We are a small hospital. We have one part time, one full time (that could be you) and myself. We process about 5000 cases a year, we average about 15-40 blocks a day. Monday's are kinda heavy with around 70 blocks the rest of the week is easy. This is Dayton Children's Hospital, good benefits, not a whole lot of stress. If you're looking for a great place with a great group of people give me a call, or call HR at 937-641-8090 and ask for Dan Krauss. Or just apply online at http://www.childrensdayton.org/CMC_Careers/index.html If you want more specifics you can call me at 641-3000 ext 8229. Please no Headhunters, we are not allowed to use employment agencies, thanks. Matt Chase Supervisor of Pathology NOTICE: The information contained in this e-mail and any accompanying documents or files is intended for the sole use of the recipient to whom it is addressed, and may contain information that is privileged, confidential, and prohibited from disclosure under applicable law. If you are not the intended recipient, or authorized to receive this on behalf of the recipient, you are hereby notified that any review, use, disclosure, copying, or distribution is prohibited and possibly a violation of federal/state law or regulations. If you received this information in error, please notify The Children's Medical Center of Dayton immediately via telephone at (937) 641-5293, or via electronic mail cmcconfidential...@childrensdayton.org and promptly destroy the original message. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
