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Based on a review of policies, procedures, other documentation and interviews it was determined that the closed record of patient #1, of 6 closed and 4 open surgical records, revealed that the hospital failed to consistently enforce the Operating Room Policy Manual (revised 12/12) for the Care and Handling of Procedural Surgical Specimens, resulting in the loss of patient #1's specimen.
Patient #1 presented on April 11, 2013 for a left salpingo oophorectomy by mini-laparotomy which is a procedure to remove the ovary and fallopian tube by way of a small incision.
The hospital policy for the Care and Handling of Procedural Surgical Specimens (revised 12/12) reveals the responsibilities of the Circulating Nurse and Scrub Person. According to policy, the circulating nurse is responsible in part to " ...receives the specimen from the sterile field using standard precautions," and, "Places the specimen in the appropriate container." The responsibilities of the scrub person in part are to "Assist circulating nurse in identification of the specimen(s) and type test required."
In practice, the physician removed the specimen, and gave it to Scrub Person #1. Scrub person #1 placed the specimen in a kidney basin and placed the kidney basin on the sterile "back table." Contrary to policy, the circulating nurse who entered the operating room (OR) on the opposite side of patient table from scrub person #1, placed the formalin-filled specimen cup on the case cart, which was also on the opposite side of the patient table from scrub person #1. Other documentation reveals that the circulating nurse and scrub person #1 verbally identified the specimen, how the specimen should be labeled. The circulating nurse made out the label for the specimen cup and performed other documentation. The circulating nurse reported she informed Scrub person #1 to put the specimen in the cup, and stated to scrub person #1, "Don't forget." However, and per policy, the circulating nurse should have received the specimen in the specimen cup from scrub person #1. The circulating nurse then reportedly turned her attention to getting patient #1 to the Post Anesthesia Care Unit (PACU) and left the operating room.
Interview with the Executive Director of Surgical Services on 5/31 at approximately 11 am, reveals that a formalin spill occurred the previous day when a lid had been unscrewed, but not fully removed. The spill prompted the circulating nurse to retain the lid on the specimen cup for concern that a formalin spill could occur again. This does not account for the fact that the specimen cup was left at a distance from scrub person # 1, on the other side of the patient table. Additionally, it was revealed that "sometimes" the circulating nurse receives the specimen in the cup and "sometimes" the scrub person places the specimen in the cup. This revealed the ongoing potential for confusion regarding OR staff responsibilities related to specimen handling.
Scrub person #1 reported her assumption that when told by the circulating nurse that the specimen cup was on the case cart, that the circulating nurse had already placed the specimen in the cup. The scrub person cleaned up the back table, which still held the specimen, and the specimen was accidentally thrown away. The loss of the specimen was appropriately reported to patient #1 and a plan was made for continuing long-term follow-up.
The scrub person also per policy, "Takes permanent specimens to the Utility Room after the end of each case and follows the procedure for disposition of permanent specimens." When in the Utility Room, the scrub person is responsible for completing the specimen log with the patient name, date, time, number of specimens, and the initials of the person completing the log. The scrub person reported that she did take the labeled specimen cup to the Utility Room, but does not report filling out the log book. Review of the log book appears to reveal the initials of scrub person #2 who denied ever signing the log book in that case. The hospital has initiated a new policy in which the circulating nurse is responsible for receiving, handling and documentation of all surgical specimens.
In summary, the circulating nurse was not present to receive the specimen in the cup per policy contributing to a change in procedure and the loss of a specimen. Additionally the scrub person did not fill in the specimen log book per policy, resulting in the loss of a verifiable chain of custody. Consequently, the hospital failed to maintain consistent quality care related to the handling of surgical specimens.