HospitalInspections.org

Based on interview and document review, the facility failed to ensure that only the Governing Body had authority to grant temporary privileges to a physician, to provide care in the facility.

Findings:

A review of the Medical Staff Bylaws, dated 2012, was conducted on 6/27/12, at 10:45 A.M. The bylaws specified that temporary privileges may be granted by the Chief Executive Officer (CEO) or the Chief of Staff (COS) or their designees, to a physician who is currently a member, in good standing, of a medical staff at another hospital [in the same healthcare system], on a case by case basis.

An interview with the CEO was conducted on 6/28/12, at 11:30 A.M. The CEO acknowledged that the Medical Staff Bylaws specified that the CEO or the COS or their designees, had authority to grant temporary privileges. The CEO stated that the CEO and COS are members of the Governing Body at this hospital. The CEO also acknowledged that the designees specified in the bylaws, may allow for the potential for non-governing board members to be given the authority to grant temporary privileges.

Based on observation, interview and record review, the facility failed to ensure that expired medications were not available for patient use. The emergency crash cart on the medical/surgical unit contained 2 expired syringes.

Findings:

On 6/26/12, at 11:10 A.M., during a tour of the medical/surgical unit, an inspection of the emergency crash cart was conducted. The emergency crash cart was opened and inventoried with the licensed nurse charge nurse (LNCN) 1. The following discrepancy was observed:

Two 10% calcium chloride injection 10 millimeter syringes, were noted to have an expiration date of 6/1/12.

On 6/26/12, at 11:12 A.M., an interview was conducted with LNCN 1. LNCN 1 acknowledged that the 2 calcium chloride syringes were out of date. LNCN 1 stated that the 2 syringes should have been removed from the emergency crash cart medication supply.

On 6/28/12, the "Expiration Dating - Medications," policy and procedure was reviewed. Per the policy, "...C. Expiration date: In all cases where the manufacturer's date applies...unless otherwise specified as day of the month by manufacturer..."

Based on interview and document review, the hospital failed to ensure that a surgical policy and procedure was developed and implemented, related to the identification and verification of surgical implants (prostheses).

Findings:

Patient 1 was admitted to the hospital on 4/25/12 with a diagnosis of osteoarthritis of the right knee, according to the admission face sheet. A review of Patient 1's medical record was conducted on 6/12/12, at 2:50 P.M. According to the Intra-Operative Record, Patient 1 was taken to the Operating Room (OR) and underwent a Right Total Knee Replacement on 4/25/12. Also documented in the Intra-Operative Record was a list of implants that were inserted during Patient 1's Right Total Knee Replacement surgery.

The implants listed were:

Femoral Posterior Stabilized
Oval Dome Patella
Tibial Tray
Tibial Insert

A progress note written by Patient 1's surgeon (MD 1) on 4/26/12, at 4:30 P.M. indicated, "I was notified by the [company] Rep (representative) [name] that yesterday I implanted a TC3 (tibial) insert not the stabilized plus (tibial) insert that I had asked for. He acknowledged that he verbally told me he was opening the stabilized plus insert, but he made a mistake." Patient 1 was taken back to the OR on 4/26/12, and underwent a Right Total Knee Revision. During the surgical procedure the TC3 tibial insert was removed and a Posterior Stabilized Plus tibial insert was implanted.

An interview was conducted with the Director of Acute Care (DAC) on 6/12/12, at 3:00 P.M. The DAC stated that the hospital had no formal policy regarding identification and verification of a surgical implant, prior to insertion of the implant during a surgical procedure.

On 6/13/12, at 8:35 A.M., an interview was conducted with the Lead Clinical Registered Nurse (LCRN) of the OR. The LCRN stated that Sales Representatives from the total joint vendor were present for all total joint replacements at the hospital. The Sales Representatives are considered Health Care Industry Representatives (HCIR). The LCRN explained that the HCIR's role was to identify the implant that the surgeon actually requested during the surgery. The HCIR should show the implant description (indicated on the implant box) to the surgeon, and then open the box and give the sterile packaged implant to the circulating RN.

An interview was conducted with the HCIR on 6/13/12 at 10:15 A.M. The HCIR stated that when the surgeon asked for a Posterior Stabilized Plus tibial insert, he went to the OR's supply room and grabbed a TC3 tibial insert instead of a Posterior Stabilized Plus tibial insert. He returned to the OR suite and announced to the surgeon that he had a Posterior Stabilized Plus tibial insert, and handed it to the circulating nurse. It was not until the next day that the HCIR realized that he had picked out the wrong tibial insert. The HCIR further explained that a TC3 tibial insert is 4 mm (millimeters) higher than the Posterior Stabilized Plus model and the TC3 tibial insert is not compatible with the Posterior Stabilized Femoral implant. Therefore, the TC3 tibial insert was removed the next day and replaced with Posterior Stabilized Plus model.

On 6/26/12, at 2:15 P.M., an interview was conducted with the Chief Nursing Officer (CNO) and the Director of Quality (DQ). Both the CNO and the DQ acknowledged that it was the hospital's practice to follow the Association of periOperative Register Nurses (AORN) standards.

An interview was conducted with Patient 1's surgeon (MD 1) on 6/27/12, at 3:45 P.M. MD 1 stated that during Patient 1's Total Knee Replacement procedure, he had decided that he wanted a tibial insert with more stability, so he asked the HCIR for a Posterior Stabilized Plus tibial insert. The HCIR held up a box and said, "I am opening a Stabilized Plus," and announced the size. The HCIR was across the room from the surgeon and the surgeon could not read the implant description on the box. The surgeon approved the tibial insert and the HCIR opened the box and handed the sterile packaged tibial insert to the circulation nurse to give to the scrub technician.

According to the AORN Guidance Statement: The Role of the Health Care Industry Representative in the Perioperative Setting, "Policies should be developed in collaboration with the facility's risk manager and/or legal counsel to ensure compliance with applicable local, state, and federal laws. Each facility should develop a system that clearly delineates limits on the health care industry's activities in the room where the surgical or other invasive procedure is performed..."