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ONE MELLON WAY

LATROBE, PA 15650

WRITTEN PROTOCOL FOR TISSUE SPECIMENS

Tag No.: A0585

Based on review of facility documents, and staff interviews (EMP), it was determined the facility failed to adopt policies/procedures to ensure that specimens received in the laboratory matched the requisition form and container label, listing specimens sent, for one of one patient. (PT1)

Findings include:

Review of the laboratory policy entitled "Policy for Timely Communication and Documentation of Significant or Unexpected Cytology, Gyne, Non-Gyne, and Surgical Pathology Findings, Version #3", dated January 2010, revealed "Principle: Certain cytology, gyne, non-gyne, and surgical pathology diagnoses may be considered significant or unexpected. Such diagnoses may include, but are not limited to: malignancy in an uncommon location or specimen type, change of a frozen section diagnosis after review of permanent sections, significant infectious organisms identified on special stains, tangential sections of fallopian tube in patients with desired infertility, blood vein instead of fallopian tube as surgical specimen, unexpected infection ... Reasonable effort should be made by the pathologist to contact the clinician of "significant" or "unexpected" findings ... Procedure: 1. The physician of the case is paged and/or telephoned. 2. Significant or unexpected findings are reported to the physician by the pathologist. 3. Documentation of the date and time notification is included in the cytology or surgical pathology report."

1) Review of the Operating Room Log, revealed that laboratory personnel had picked up three specimens (uterus, tubes, ovaries) of the patient's (PT1) for transport to the laboratory. The patient's pathology requisition form listed three specimens (uterus, tubes, ovaries.)

2) Review of the patient's pathology report revealed that the container was labeled as containing three specimens (uterus, tubes, ovaries.) The pathology report stated that definite ovaries and fallopian tubes were not readily identified.

3) A telephone interview with EMP11 on May 24, 2010, at approximately 1:15 PM, revealed "... I identified what was there and noted there wasn't any ovaries ... It's not rare that there are discrepancies, especially polyps and GI [gastrointestinal] cases. I compare the label to what's in the container ... We don't typically call for discrepancies. Discrepancies are frequent in GI cases. In retrospect, I would have called the OR [Operating Room] ... In retrospect, I should have called ... ."

4) A telephone interview with EMP6 on June 15, 2010, at approximately 9:30 AM, revealed "... Lab is to initiate a specific check for specimens sent to pathology ...The pathologist is to check with the form that is sent from the OR. There should have been a call ... They are to initiate a specific check for all specimens related to pathology ... ."

5) A telephone interview with EMP2, on June 17, 2010, at approximately 10:00 AM, revealed "...We're going to start doing specific checks of specimens on arrival. We're also going to do education for all of us to remind everyone of significant findings of what we do if the specimens don't marry up with the form. We're going to make sure a call is made ... ."

6) A telephone interview with EMP13, on June 17, 2010, at approximately 11:15 AM, revealed "... You should immediately call the OR if the tissue isn't there ... ."