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34TH ST & CIVIC CENTER BLVD

PHILADELPHIA, PA 19104

CONTENT OF RECORD: COMPLICATIONS

Tag No.: A0465

Based on review of facility documents and medical records (MR), and interview with staff (EMP), it was determined that the facility failed to document an operative complication in one of one medical records (MR1),

Findings include:

Review of facility policy "Count Policy for Sponges, Sharps, Instruments and Miscellaneous Items" revised May 2008, revealed " 2. Practice II - Sharps and related miscellaneous items should be counted on all procedures, establishing a baseline for subsequent counts. ... When a discrepancy in the count(s) is identified, the surgical team is responsible for carrying out steps to locate the missing item, steps include, but are not limited to: 1. Report the discrepancy to the surgical team 2. Suspend procedure if the patient's condition permits 3. Manual inspection of the operative site 4. Visual inspection of the area surrounding the field : a. Floor b. Kick buckets c. Linen d. Trash receptacles 5. If item is still unaccounted for, call the charge nurse 6. If item is still unaccounted for, an intra-operative x-ray must be obtained, which should be taken and read by the attending Radiologist before the patient leaves the OR....8. If still unable to account for the missing item at case end: a. Document the count as INCORRECT b. Complete an Incident Report 5. Practice V - Sponge, sharp and instrument counts should be documented on the patient's intra-operative record. Documentation of counts should include but not limited to: 1. Types of counts ( i.e., sponges, sharps, instruments, and miscellaneous items) and the number of counts performed ...3. Results of surgical item counts 4. Notification of the surgeon...6. Actions taken if count discrepancies occur (X-ray, search of wound, or room, etc.) 7. Outcome of actions taken...".

1) Review of MR1 Operating Room fluoroscopy report dated February 12, 2010, on May 21, 2010, at 4:14 PM revealed, "...Findings are limited by artifact. On 1 of the final images, there is faint curvilinear opacity projecting through the right upper pelvis of uncertain etiology, possibly artifact. No definite metallic foreign body is identified. Please see full procedure report for further details."

Review of MR1's "Progress Record Operative Note" dated February 12, 2010, revealed "Needle count correct at end of procedure" was checked and signed by OTH1 and EMP2. Review of the Operative Report dictated by OTH1 on February 12, 2010, revealed "There was no intraoperative complications." Review of the "Intraoperative Nursing Plan of Care" dated February 12, 2010, revealed, "Final Counts Needles was incorrect."

3) Interview with EMP2 on May 21, 2010, at approximately 2:15 PM confirmed that they had assisted with the laparoscopic resection performed by OTH1 on February 12, 2010.
EMP2 confirmed that the needle could not be found while the patient's abdomen was still incised. EMP2 confirmed that the needle count was incorrect at the end of the surgery, and further confirmed that OTH1 used the laparoscopic telescope twice to survey the abdominal cavity in search of the missing needle, which could not be visualized. Continued review of MR1 revealed several fluoroscopic views of the abdomen were obtained, as well as a third attempt with the laparoscopic telescope to visualize the needle. There was no documented evidence in MR1 of the above attempts to locate the missing needle other than the fluoroscopic study.