As an LIS company we frequently see inspectors making up requirements. Sometimes it makes sense to appeal them sometimes it's easier to do what they want even if it isn't an actual requirement. I will admit that I had seen medical directors listed on laboratory reports so often that I found the idea that it was required plausible. I checked my copy of CLIA when the first post was made and was surprised to find that it wasn't there. The most common confusion is between the requirements for test reports (493.1291) and requirements for test records (493.1283).

I would suggest that the advent of patients having the right to get their lab report would be an argument against the medical director being listed as this is probably not the person that the patient should be calling for an explanation of their report. This is just my opinion, of course.

William Shipley
Schuyler House

----- Original Message ----- From: "Victor A. Tobias" <vtob...@uw.edu>
To: "Burke Reed" <burk...@hotmail.com>
Cc: <histonet@lists.utsouthwestern.edu>
Sent: Monday, April 28, 2014 11:22 AM
Subject: RE: [Histonet] Pathology Report Templates


Here is the explanation from the CAP inspector, not a requirement yet.

Okay I just talked to Anita about why the inspector wanted CLIA number and Director Name on report and the reason why is that the inspector said that patients are now having easier access to their reports, and laboratories are placing this information on the reports for references, and this is something that will be necessary in the future, and he for some reason wanted to see that we were going to do this.


Victor Tobias HT(ASCP)
Clinical Applications Analyst
Harborview Medical Center
Dept of Pathology Room NJB244
Seattle, WA 98104
vtob...@u.washington.edu<mailto:vtob...@u.washington.edu>
206-744-2735
206-744-8240 Fax
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Privileged, confidential or patient identifiable information may be contained in this message. This information is meant only for the use of the intended recipients. If you are not the intended recipient, or if the message has been addressed to you in error, do not read, disclose, reproduce, distribute, disseminate or otherwise use this transmission. Instead, please notify the sender by reply e-mail, and then destroy all copies of the message and any attachments.
________________________________
From: Burke Reed [mailto:burk...@hotmail.com]
Sent: Thursday, April 24, 2014 12:24 PM
To: Victor A. Tobias
Subject: RE: [Histonet] Pathology Report Templates

I reviewed the 2014 CAP checklist twice. I see no mention of a requirement for CLIA# and Medical Director to be on the final pathology report.

Burke Reed, III

From: vtob...@uw.edu
To: histonet@lists.utsouthwestern.edu
Date: Thu, 24 Apr 2014 17:50:30 +0000
Subject: [Histonet] Pathology Report Templates

One of our facilities had a CAP inspection last week and I was asked to add the CLIA# and Medical Director to the template, immediately. Is this something new, as we had our CAP inspection last Aug. and there was no mention about CLIA# or having the Director's name on the templates?

I haven't been able to get any follow-up from the lab supervisor.

Victor Tobias HT(ASCP)
Clinical Applications Analyst
Harborview Medical Center
Dept of Pathology Room NJB244
Seattle, WA 98104
vtob...@u.washington.edu<mailto:vtob...@u.washington.edu>
206-744-2735
206-744-8240 Fax
=================================================
Privileged, confidential or patient identifiable information may be contained in this message. This information is meant only for the use of the intended recipients. If you are not the intended recipient, or if the message has been addressed to you in error, do not read, disclose, reproduce, distribute, disseminate or otherwise use this transmission. Instead, please notify the sender by reply e-mail, and then destroy all copies of the message and any attachments.

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