HospitalInspections.org

Based on record review and interview it was determined that the governing body failed to demonstrate responsibility for the conduct of surgical services, in that a contraindicated device was used routinely by one of two donor surgeons (Staff #3) during donor laparoscopic nephrectomies, citing as example for 5 of 8 donor nephrectomies done on 1/27/11 and 1/28/11, with no evidence the Governing Body was made aware of the contraindication of the use of the device in the ligation of the renal artery in laparoscopic donor nephrectomies or had been consulted or approved the use of the device for these procedures, citing as examples patient #'s 1, 2, 4, 7 & 8 of the sample of patient #'s 1-8 of donor nephrectomies performed on 1/27-1/28/11.

Findings:
For deficient practices related to the failure to require the medical staff to be accountable to the governing body, see A0049.

Based on record review and interview it was determined that the facility failed to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. A contraindicated device was used for donor laparoscopic nephrectomies with no evidence that the Governing Body had been requested to approve the use of this device in this procedure, This deficient practice presented a risk to all kidney donors participating in the transplant program.

Findings:
Review of medical records on 2/17/11, revealed that a contraindicated device (Weck Hem-o-lok clip) was used for ligating the renal artery during laparoscopic donor nephrectomies for 5 of 8 patients whose surgeries were performed on 1/27/11 and 1/28/11:

? Patient #1 on 1/28/11
? Patient #2 on 1/27/11
? Patient #4 on 1/27/11
? Patient #7 on 1/28/11
? Patient #8 on 1/28/11

The package insert for the Weck Endoscopic Hem-o-lok Applier removed from a packaged applier presented by staff member # 5 on 2/17/11 as part of the instrument tray routinely provided for donor nephrectomies included the following under the heading "contraindications:" "Hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laproscopic donor nephrectomies".

An interview was conducted with the Staff #11 (Director of Peri-Operative Services) on 2/17/11 at about 4:15 p.m. in a conference room of Methodist Hospital Transplant Program. Staff #11 stated that she was not aware of the Weck notice of contraindication of use of the Weck Hem-o-lok Clips for donor nephrectomy and she could not find any information to verify that she was notified of the recall. Staff #11 provided the two donor surgeon's (Staff #'s 3 and 4) preference cards for laparoscopic donor nephrectomies. Staff #3's preferences included Weck Hem-o-lok clips listed as a requested device for arterial ligation, without any type of a warning or contraindication present. On 2/18/2010 Staff #11 provided a revised copy of Staff #3's physician preference card which had "Hem-o-lok is not to be used on renal arteries" typed across the list of supplies. The physician preference card for Staff #4 did not have Hem-o-lok listed as a preference for arterial ligation.

An interview was conducted with Staff #3 (Donor Surgeon) on 2/17/11 at 1:00 pm in a conference room of Methodist Hospital Transplant Program. Staff #3 stated that he regularly used the Weck Hem-o-lik clip for ligating the renal artery during laproscopic donor nephrectomies in conjunction with a titanium clip. Staff #3 stated that he was aware of the Weck Hem-o-lok contraindication, but he believed that he "addressed the contraindication by using the metal clip more proximal to the donor's aorta."

An interview was conducted with the (Staff #2) Director of Quality/Regulatory Services on 2/18/11 at about 2:00 p.m. in a conference room of Methodist Hospital Transplant Program. When asked if the facility's Governing Body approved the continued use of the contraindicated Weck clips after the warning was issued in 2006 and re-issued in 2008, she was unable to provide any information to indicate that the Governing Body was apprised of the contraindication and had approved the use of the contraindicated Weck Hem-o-lok clips for ligating the renal artery during a laproscopic donor nephrectomy.

Based on record review and interview it was determined that the facility failed to implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment performance improvement program in that the hospital failed to identify and reduce medical errors by ensuring that a warning of a contraindication for use of a medical device was received and acted upon by staff responsible for the operating room (the Weck Hem-o-lok clip). This deficient practice placed all donors participating in the kidney transplant program at risk of harm.

Findings:

For deficient practices related to the failure to ensure dissemination of medical device recalls to responsible staff and end users, see A266.

Based on document review and interview the facility failed to ensure that the transplant program had a functional ongoing Quality Assessment & Performance Improvement (QAPI) system in that the transplant program QAPI failed to identify benchmarks and did not demonstrate that outcomes were reviewed against expected targets to allow identification of areas where improvements or changes were needed. The transplant program QAPI failed to track donor outcomes and issues pre and post donation. The transplant program failed to include a Nutritionist or Social Worker in the QAPI quarterly meeting for 4/4 meetings in the last 12 months as expected by these regulations and required by policy. These deficient practices present a risk to all patients in the Adult Kidney Only transplant program.

Findings:
The following documents were reviewed on 2/18/11:

- Facility document entitled "Abdominal Transplant QA Presentation" dated July 2010 and characterized by the Director of Abdominal Transplant Services (Staff #9) as a QAPI report, identified transplant patient outcomes, and failed to identify benchmarks or to demonstrate that outcomes were reviewed against expected targets to allow identification of areas where improvements or changes were needed. There were no objective measures tracked for living donors regarding pre and post donation outcomes.

- Facility document entitled "2010 Monthly and Quarterly Performance Improvement Metrics- Kidney Transplant" listed objective measures for the kidney program from Jan 2010 to Sept 2010; there was no data included from Oct 2010 to present (2/18/11). This document identified patient outcomes; it failed to identify benchmarks or to demonstrate that outcomes were reviewed against expected targets to allow identification of areas where improvements or changes were needed. There were no objective measures tracked for living donors regarding pre and post donation outcomes.

- The records of the last four "Quarterly Transplant Operations & Quality Meetings," dated 2/22/10, 4/26/10, 7/26/10 and 11/30/10 were reviewed. None of these included evidence of the use of benchmarks to measure quality. There was no representative for Social Services or Nutrition present at any of these meetings.

- Facility policy entitled "QA/QI for Transplant Program," which was marked "not approved yet," identified "Core Members" of the QA/QI program as including "Social Services" and "Nutritionists".

An interview was conducted with the Director of Abdominal Transplant Services (Staff #9) on 2/18/11 at about 10:45 a.m. in a conference room of Methodist Hospital Transplant Program. Staff #9 confirmed that her department's QAPI program does not compare their outcomes to benchmarks for patient outcomes and transplant processes during QAPI meetings. Staff #9 confirmed that no objective measures are collected to evaluate the pre and post transplant phases of the donor experience. Staff #9 also confirmed that a Nutritionist and Social Worker have not attended QAPI meetings for the past 4 quarterly QAPI meetings.

Based on record review and interview it was determined that the facility's quality assessment performance improvement program failed to disseminate effectively a warning of a contraindicated medical device (Weck Hem-o-lok clips) for laparoscopic donor nephrectomies to Operating Room Management. This deficient practice presented a risk to living kidney donors who could be exposed to the use of contraindicated medical devices.

Findings:
An interview was conducted with Staff #13 (Central Supply Risk Manager) on 2/18/11 at 9:30 a.m. in a conference room of a supply facility for Methodist Hospital. Staff #13 stated that her department did not get the 2006 Weck notice regarding the Hem-o-lok clips contraindications. She stated that her department did receive the repeat notice in 2008, and provided a copy of the Weck clip notice of contraindications she received from Teleflex Medical dated 4/21/2008 to the surveyors. She also provided an acknowledgment form that she sent to Methodist Hospital Transplant Program, which was signed by Staff #16 (OR Supply Coordinator) and dated 4/30/08.

An interview was conducted with Staff #16 on 2/18/11 at 12:15 p.m. in a conference room of Methodist Hospital Transplant Program. Staff #16 stated that she could not remember receiving the Weck notice, as she was new to her job at the time. She stated that at that time she did not have a process for removing items that are recalled, but now she does. She stated that now she gives such notices to Staff #11 (Director of Peri-Operative Services), who then notifies the physicians.

An interview was conducted with Staff #11 on 2/17/11 at about 4:15 p.m. in a conference room of Methodist Hospital Transplant Program. Staff #11 stated that she was not aware of the Weck notice of contraindications for use of the Hem-o-lok clips for laparoscopic donor nephrectomy and she could not find any information identifying that she was notified of this issue. Staff #11 stated that she gets recall notices via email from several different sources including material management, vendors, and risk management. She stated that once she is made aware of recalls she has a staff member pull the item off of the shelf and for restricted use recalls (such as the Weck clips) she contacts the doctors that use the device and personally notifies them. Staff #11 stated that she was unsure as to why she did not get the Weck recall. On questioning, she stated that she does not have a system to document when or how she notifies physicians of recalls or contraindications.

An interview was conducted with the Staff #5 (OR Manager) on 2/17/11 at about 11:00 a.m. in a conference room of Methodist Hospital Transplant Program. During the interview he presented the instrument trays that would be provided to the surgeon for a laparoscopic donor nephrectomy. One of the devices included was a Weck Endoscopic Hem-o-lok Applier and clips. The packaging of the applier included the notice of the contraindication for use for ligating the renal artery in a laparoscopic donor nephrectomy. Staff #5 stated that he was unaware of this contraindication or of the notice regarding this from Weck.

A policy entitled "Product Recalls-Medical/Surgical Supplies and Equipment", dated November 2005, stated "The department receiving the recall notification from Materials Management is responsible for informing the physician involved in using the products of the recall notification and its contents."

Review of medical records on 2/17/11, revealed that a Weck Hem-o-lok clip was used for ligating the renal artery during laproscopic donor nephrectomies for 5 of 8 patients on 1/27/11 and 1/28/11:

? Patient #1 on 1/28/11
? Patient #2 on 1/27/11
? Patient #4 on 1/27/11
? Patient #7 on 1/28/11
? Patient #8 on 1/28/11

Interview of Staff member # 3 (Donor Surgeon) on 2/17/11 at 1 pm revealed his routine practice was to use a Weck Hem-o-lok clip and a Titanium clip to ligate the renal artery. Staff #3 stated that he was aware of the Weck Hem-o-lok contraindication, but he believed that he "addressed the contraindication by using the metal clip more proximal to the donor's aorta."

Based on document review and interview the facility failed to ensure that the transplant program program had a functional ongoing QAPI system in that the transplant program QAPI failed to conduct an analysis for 13 of 14 adverse events. This deficient practice presents a risk to all patients in the Adult Kidney Only transplant program.

Findings:
The following documents were reviewed on 2/18/11:

- Facility document entitled " Transplant Medication Error Discussion " identified 11 separate medication errors for the time period of January 2010 to December 2010 and actions to correct each error on an individual basis. There was no documentation of aggregate data collection or trends identified and tracked regarding the medication errors.

- Facility document entitled " Mortality and Morbidity Conference - Abdominal Transplantation - Methodist Specialty and Transplant Hospital" which stated that it was an "agenda and minutes - for January 7, 2011 ...covering the Morbidity and Mortality over the period of 8 - 2010 to 12 - 2010". This document addressed three separate cases of morbidity and mortality, two of the cases discussed stated specifically that a root cause analysis was not conducted.

An interview was conducted with the Director of Abdominal Transplant Services (Staff #9) on 2/18/11 at about 10:45 a.m. in a conference room of Methodist Hospital Transplant Program. During the interview Staff #9 confirmed that there was no documentation of aggregate data collection or trends identified and tracked regarding the 11 medication errors and that 2 of the 3 morbidity and mortality cases reviewed did not have a root cause analysis.

Based on review of documents and interview the facility failed to ensure that an operative report was dictated immediately following surgery for 1 of 12 surgical patients reviewed.

Findings:
Review of Patient #1's medical record on 2/17/11 revealed an anesthesia report dated 1/31/11 with a start time of 1404 (2:04 pm) and end time of 1535 (3:35 pm). There was no operative report found that coincided with the date and time of this anesthesia report.

During an interview with Staff #2 (Director of Quality/Regulatory) on 2/17/11 she stated that Patient #1 had an operation on 1/31/11 performed for irrigating and packing of a wound. After a search, Staff #2 informed the surveyors that each of the two surgeons involved thought the other one had dictated the report, and neither had dictated the report.