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Based on review of documentation, the dates the Hospital reported the Serious Reportable Event [SRE] to the Department and Patient, and interviews, the Hospital failed to ensure that the Patient had the right to make informed decisions regarding her care. The Hospital failed to ensure the Patient had the right to be involved in care planning and treatment and being able to request or refuse treatment.

Findings included:

Background information:

The Hospital reported a Serious Reportable Event [SRE] on 6/22/10 regarding a surgical burn from an instrument that occurred on 5/27/10. A Bovie tip cauterizer and Senn Retractors were used during surgery for a breast biopsy that involved two separate incisions, each about one inch long. On completion of the breast biopsy, the Surgeon noted the incision edges had a full thickness burn. The edges were excised an additional 1-2 mm for wound closure and healing.

Findings included:

1) The General Surgeon was interviewed on 6/28/10 at 4:25 pm. The General Surgeon said he did not inform the Patient about the surgical burn after the breast biopsy procedure because the Patient was still under the effects of general anesthesia. The General Surgeon said he waited until the one week post-surgical visit at his outpatient office to tell the Patient about the incident in a face to face setting. The General Surgeon said the Patient is electing to have plastic surgery to improve the appearance of the scars. Review of photographs the Surgeon provided post-operatively revealed the total length of the scared area was about four inches in length.

The Hospital mailed the Patient letter regarding the SRE after the Surgeon met with the Patient to disclose the incident.

Based on review of documentation and interviews, the Hospital failed to ensure that surgical services developed policies governing surgical care to assure the achievement and maintenance of high standards of medical practice and patient care.


Findings included:

1) After the burn was noted, the Senn Retractors were removed from the operating field and inspected. During the inspection of the Senn Retractors, a small crack/fissure was noted in the insulation coating. It was determined that the cause of the burn was due to the Bovie tip touching the metal exposed in the crack of the insulation of the Senn Retractor.
2) Although Central Sterilization staff regularly inspects surgical instruments, no documentation is logged regarding the frequency and process for surgical instrument inspections.
3) Review of the Central Sterilization policy and procedure manual indicated that there are no policies and procedures for the surgical instrument inspection process.
4) Interview with the Central Sterilization Supervisor on 6/28/10 at 9 am indicated that the Hospital does not use any particular set of national standards such as the Association of Operating Room Nurses [AORN] perioperative standards and recommended practices for inspection for breaks in instrument insulation which can cause electrical current leakage and burns.
5) The Central Sterilization Supervisor said the Manufacturer produces the Senn retractor in plain surgical grade stainless steel. The Senn Retractor was coated with insulation to prevent electrical conductivity when used near a cauterizing device which is generated by electricity. The special coating of the Senn Retractor was requested by the Surgeon and was done at an outside agency. The Central Sterilization Supervisor was not aware of any special indications to maintain the coating prior to the incident. The burn injury was not reported to the agency that coated the surgical instrument for quality improvement information.