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Based on review of facility documents and staff interviews (EMP), it was determined that the facility failed to measure success of actions aimed at performance improvement for issues identified by the United Network For Organ Sharing (UNOS) related to deceased donor vessel refrigerator storage temperatures and destruction of those vessels.

Findings include:

Review of "The UPMC Presbyterian Shadyside Performance Improvement Plan Fiscal Year 2009 ... Fiscal Year 2010 ... Fiscal Year 2011" revealed "I. Purpose The leadership at UPMC Presbyterian Shadyside develops and implements the Performance Improvement Plan. In keeping with the Mission and Vision, the Performance Improvement Plan is designed to establish, organize, implement, monitor, and document evidence of the ongoing and systematic performance improvement process. ... VI. Objective The fundamental objective of quality improvement at UPMC Presbyterian Shadyside is to continuously improve patient safety and the quality of all patient care and services. Leadership is responsible for creating and maintaining a supportive and nurturing atmosphere that empowers participants to proactively reduce risk, enhance patient safety, and initiate performance improvement activities. VII. Performance Improvement Approach ... Prioritizing Leadership sets process improvement priorities based on: established standards and guidelines; accrediting and regulatory requirements; ... Intense Analysis In addition to intense analysis for sentinel and serious events, undesirable patterns or trends in performance are analyzed under the following conditions: when data comparisons indicate that levels of performance, patterns, or trends vary substantially from those expected ... VII. Structure To Support The Implementation Of The Performance Improvement Plan: ... Total Quality Councils (TQC) The Total Quality Councils of each campus oversee, prioritize and guide the organizational performance improvement process. ... Additionally councils will: Review aggregate data reports on existing, new and revised indicators or performance measures. Review proactive risk reduction strategies based on review of internal and external data on patient safety issues."

Review of "UPMC Presbyterian Shadyside Quality Assurance/Patient Safety/Performance Improvement Program Transplant Services" revealed "Purpose The leadership of the UPMC Adult Transplant Programs develops and implements the Quality Plan. In keeping with the Mission and Vision, the plan is designed to establish, organize, implement, monitor, and document evidence of on-going and systematic performance improvement processes specifically related to the adult transplant services. ... Goals of the Quality Plan ... 3) Meet and maintain regulatory compliance standards established by CMS and the United Network for Organ Sharing (UNOS). 4) Identify, develop and implement process improvement activities which are specific to the transplant patient population and services provided. ... Performance Improvement Approach ... Internal and External Performance Data Comparative data is used to determine if there is excessive variability or unacceptable levels of performance. Comparative data is provided by internal data collection and external reference data bases, including but not limited to ... the United Network for Organ Sharing (UNOS) ... Evaluation and Effectiveness Evaluation of the effectiveness of the implementation of the Performance Improvement Plan is accomplished through the on-going measurement and analysis of the identified initiatives ..."

1) Review of facility documents revealed that in August 2008, UNOS conducted an onsite review of the facility's transplant programs. During this review, clinical and administrative issues were identified with deceased donor vessel refrigerator storage temperatures and destruction of vessels.

Further review of correspondence between the facility and UNOS, dated October 7, 2008, and January 23, 2009, revealed that the facility submitted a plan of correction to UNOS for these clinical and administrative issues identified, during the August 2008, survey.

2) Review of facility documents revealed a letter, dated December 18, 2009, from UNOS to the facility indicating that the facility will be subjected to a desk review in six months, due to the clinical and administrative issues identified during the August 2008, survey.

3) Review of facility documents revealed that in February 2010, UNOS conducted a desk review of the transplant programs. During this review, clinical and administrative issues were again found with deceased donor vessel refrigerator storage temperatures and destruction of vessels.

Review of additional documents revealed that the facility submitted another plan of correction to UNOS for those clinical and administrative issues identified during the February 2010, desk review.

4) Review of the meeting minutes for "STI Abdominal Transplant Quality Assessment and Performance Improvement", dated July 14, 2010, revealed Powerpoint slides which included the findings of the February 2010, desk review and the corrective action plan that corresponded with this review. Further review of these minutes revealed no documented evidence of any measuring or monitoring of success or tracking of performance to ensure that improvements were sustained for the corrective action plans that were submitted to UNOS.

5) A document was presented by the facility titled "Vessel Deficiencies Logs" which indicated four instances of temperatures being out of range, between the dates of March 2 to July 3, 2010. The document also indicated that there were issues with the discarding of vessels between January 6 to June 11, 2010.

6) During interview with EMP5, on September 4, 2010, at approximately 12:30 PM, EMP5 was asked what monitoring was done in relation to the corrective action plan for UNOS and EMP5 stated "We did the summary [Vessel Deficiencies Logs] this week ... [EMP4] did it ... We did that audit after we got the letter [dated August 26, 2010] from UNOS [indicating that the facility transplant program may be placed on probation by UNOS]." Further interview revealed that the auditing was completed on September 1, 2010.

7) Review of "Total Quality & Patient Safety Council" meeting minutes from October 16, 2008 to August 19, 2010, revealed no documented evidence of any measuring or monitoring of success or tracking of performance to ensure that improvements were sustained for the corrective action plans that were submitted to UNOS.

Telephone interview with EMP6 on September 22, 2010, at approximately 11:30 AM confirmed the above findings and revealed "There is one mention of vessels [unrelated to these findings]."

Based on review of facility documents, observations, and staff interviews (EMP), it was determined that the facility failed to ensure that there were proper temperature controls for the storage of deceased donor vessels.

Findings include:

Review of "Department of Surgical Services ... Storage of Vessels for Transplant ... Reviewed: January 2010" revealed "Purpose: To ensure a safe process with the storage and handling of vessels for transplant in the Montefiore Operating Room. Background: The UPMC Presbyterian Shadyside policy on Cadaveric Storage and Transplantation of Vessels ... will be followed to comply with the Organ Procurement and Transplantation Network (OPTN) policies. Policy: ... 2. The temperature is maintained between 2 degrees and 8 degrees C [Celsius] ... as per UNOS policy 5.7.6.3. ... 5. An alarm is attached to the refrigerator and if the temperature is outside of the listed ranges, and alarm will notify the security service who in turn will notify management. ... 7. If the vessels are older than 14 days from the date of recovery, the vessel is discarded by ORC."

Review of "Deceased Donor Vessel Recovery, Monitoring and Storage ... Date Revised: ... May 2010" revealed "I. Policy It is the policy of UPMC Presbyterian Shadyside (UPMCPS) to comply with all Centers for Medicare and Medicaid Services (CMS) regulations and the Organ Procurement and Transplantation Network (OPTN) Policies and Bylaws. As a member of the OPTN, UPMCPS is bound by all provisions of the OPTN charter, bylaws and policies, including amendments thereto. ... The vessels must be stored in a secured refrigerator with a range of 2 to 8 [degrees] C [Celsius]. As per UNOS policy 5.10.2 vessels can be stored up to a maximum of 14 days from the original recovery date. ... The vessels must be discarded if the refrigerator temperature is out of range for more than 2 hours. ... Procedure (ORC) ... An alarm is attached to the refrigerator and if the temperature is outside of the listed ranges, an alarm will notify [security company] who in turn will notify [EMP8]."

1) A tour of the area in which the refrigerator, for the deceased donor vessels are housed, was conducted on September 2, 2010, at 9:40 AM, with EMP4. During this tour, EMP4 stated "The fridge is hardwired into a security system ... if the temperature is out of range for more than 30 minutes, it will alarm and notify the OR (operating room) director via a page ... If vessels are out of range for more than two hours, they are no good and need to be discarded ... The temperature range needs to be between 2 and 8 degrees Celsius."

Observation of the front of the vessel refrigerator revealed a small yellow, rectangular piece of paper indicating "High Temp 10 [degrees] C (50 [degrees] F) ... Low Temp 0 [degrees] C (32 [degrees] F." During interview with EMP4, EMP4 was asked why the High and Low limits were set at 10 and 0 degrees Celsius and EMP4 stated "I don't know."

2) During a further tour of the area in which the vessel refrigerator is housed, on September 3, 2010, at approximately 10:40 AM, observation of the alarm system, located on top of the refrigerator, revealed that the when the "Hi" button was pressed, it indicated that the High temperature setting was set for 10 degrees Celsius and when the "Lo" button was pressed, it indicated that the Low temperature setting was set for 0 degrees Celsius.

3) During an additional tour of the area in which the vessel refrigerator is housed, on September 3, 2010, at approximately 1:30 PM, staff were shown the observation that the High and Low limit on the refrigerator monitor were set at 10 degrees and 0 degrees Celsius. During interview with EMP8, EMP8 was asked when the alarm system sounds and EMP8 stated "I think it is when it goes above 10 or below 0 [degrees Celsius]."

During this tour, the surveyor observed a "Operating Instructions Manual" on top of the vessel refrigerator. Review of this manual revealed "Hi (High Limit) This is the high temperature limit. When in Normal Run mode, the alarm will trigger if the probe reads a temperature equal to or above the high temperature limit. ... Lo (Low Limit) this is the low temperature limit. When in Normal Run mode, the alarm will trigger if the probe reads a temperature equal to or below the low temperature limit."

4) During interview with EMP5, on September 3, 2010, at approximately 1:40 PM, EMP5 was asked how the facility would know if the temperature of the vessel refrigerator was 1 degree or 9 degrees Celsius for any given two hour period of time and EMP5 stated "We can't."