HospitalInspections.org

Based on a review of facility policy, documentation and staff interviews (EMP), it was determined the facility failed to ensure the contracted services (OTH1 and OTH2) had met all applicable Federal and State regulations.
Findings include:
A review on January 13, 2016, of the facility's policy, Reprocessing of Medical Devices Labeled for *Single Use Only* effective September 12, 2011, revealed "...Corporate Materials Management, in collaboration with appropriate clinical departments, will designate/authorize a qualified third party company(ies) for the reprocessing of single use medical devices and contract with that company for such services."
A review on January 13, 2016, of facility documents, Governing Body Meeting Minutes for February 10, June 9, October 9, December 16, 2015, revealed no documentation that the contracted services (OTH1 and OTH2) had been reviewed by the governing body to ensure all applicable Federal and State Regulations had been met.
A review on January 19, 2016, "U.S. Food and Drug Administration: Compliance Policy Guide Sec. 300.500 *Reprocessing of Single Use Devices* (CPG 7124.16), released date March 18, 2005, last updated April 20, 2005, revealed "Policy: Firms and hospitals that are reprocessing SUDs are considered by FDA to be manufacturers and as such must comply with all of the following and regulatory requirements:
Quality System Regulation (Section 520(f) of the Act; 21 CFR Part 820)
Medical Device Reporting (Section 519 (a), (b) and (c) of the Act; 21 CFR Part 803)
Registration and Listing (Section 510 of the Act; 21 CFR Part 807)
Labeling (Section 502 of the Act 21 CFR Part 801)
Premarket Approval and Premarket Notification (501(k)) Section 510, 513 and 515 of the Act; 21 CFR Part 807 and 21 CFR Part 814)
Medical Device Corrections and Removals (Section 519(f) of the Act; 21 CFR Part 806)
Medical Device Tracking (Section 519(e) of the Act 21 CFR Part 821)."
A review on January 12, 2016, of facility document, "Registration Information" dated December 9, 2014, revealed Registration Status: Expiration Date: December 31, 2015.
An interview conducted on January 13, 2016, at 2:05PM, with EMP2, EMP3 and EMP23 confirmed the expiration date for the registration status for contracted service (OTH2) was December 31, 2015. Further interview with EMP2 and EMP3 revealed that the facility could not produce documentation ensuring that the contracted services (OTH1 and OTH2) had met all applicable Federal and State Regulations.
An interview conducted on January 19, 2016, at 2:15PM, with EMP23 revealed "The contracts for contracted services, (OTH1 and OTH2) were not taken before the governing board and we do not know at this time if all applicable Federal and State Regulations have been met."

Based on a review of facility policy, documentation and staff interviews (EMP), it was determined the facility failed to evaluate contracted services (OTH1 and OTH2) to ensure the services were provided in a safe and effective manner.
Findings include:
A review on January 13, 2016, of the facility's policy, Clinical Effectiveness and Quality Improvement (CEQI) Performance Plan last updated February 2012 revealed " ...Contracted Services-Contracted services that are directly related to patient care are evaluated through the CEQI structure to ensure that they are provided safely and effectively and in accordance with hospital policies, law and regulation including Medicare conditions of participation."
A review on January 13, 2016, of the facility's, Clinical Effectiveness and Quality Improvement (CEQI) Performance Plan last updated February 2012 revealed "Scope. CEQI evaluation and performance planning involves all aspects of clinical care and supporting services at the Hospital University Of Pennsylvania ... Objectives for CEQI include: Improving safety and outcomes of patient care ...promoting clinical excellence and quality of care ... CEQI ... Initiates and oversees formation and function of PI teams, Reviews performance improvement data and reports. ..Unit Based Clinical Leadership Teams (UBCLs) ... HUP has a adopted a model of leadership on its clinical units which pairs a physician leader with a nurse leader, who are supported by quality and patient safety project managers at the front line level. The physician-nurse leadership pair manages the unit and focuses the UBCL team on specific activities such as interdisciplinary round and oversight of performance improvement projects. Results of UBCL team activities are documented and reported to the services/departments involved, administration and CEQI committee. Clinical Leadership debriefings and rounds are held monthly with each of the UBCLs. 10. Quality Control Activities- Equipment used for monitoring patients physiologic status ... "
A review on January 19, 2016, of the facility's policy, Contracted Services Quality Monitoring Process Number 1-12-36, effective January 25, 2010, revealed "Purpose. The purpose of this policy is to ensure that contracted services for the care, treatment and service provided directly to patients by contractual arrangement from an outside vendor (also referred to in this policy as "Clinical Contracts") meets the same standards of safety and effectiveness as services provided to patients by HUP...personnel. Procedure. 2. The Originator, in consultation with the administrator, manager, supervisor or other designated senior leader(s) who oversees the particular Clinical Contract, must identify and document the specific quality measures and expectations for the outside vendor which will be monitored for the contracted service and the method of monitoring them annually. Examples of options for monitoring the outside vendor's performance include review of information for the vendor's Joint Commission accreditation or certification status;...review of periodic reports submitted by the vendor; ...review of performance reports based on indicators set forth in the contract."
A review on January 13, 2016, of the facility's Clinical Effectiveness and Quality Improvement (CEQI) Meeting Minutes for February 5, March 5, April 2, May 7, June 4, July 2, August 6, September 3, Ocotber 1, November 5 and December 3, 2015 revealed no documentation that performance monitoring for the contracted services OTH1 and OTH2 had not been completed to ensure the services were provided in a safe and effective manner.
A review on January 13, 2016, of facility documents EP UBCL agenda and committee meeting minutes for August 10, September 10, October 26, and November 9, 2015, revealed no documentation that the contracted services (OTH1 and OTH2) had been evaluated and the service was provided in a safe and effective manner.
A review on January 13, 2016, of facility documentation (excel spreadsheet) received from EMP3 and EMP27 revealed, "2015 Returned reprocessed product to OTH1, 1 Carto Cable Cr3434ct and 1 Dynamic Deca R201101."
An interview conducted on January 13, 2016, at 1:10PM with EMP14 confirmed that performance monitoring for the contracted services (OTH1 and OTH2) had not been evaluated in the Clinical Effectiveness and Quality Improvement Meeting for the months of February, March, April, May, June, July, August, September, October, November and December of 2015.
An interview conducted on January 13, 2016, at 2:55PM with EMP2, EMP3, and EMP17 confirmed the facility's UBCL committee had not completed performance monitoring for contracted services, (OTH1 and OTH2). Further interview with EMP2, EMP3 and EMP17 confirmed that the Carto CableCr3434ct and Dynamic Deca R201101 reprocessed medical equipment was returned to contract service (OTH1) has dysfunctional and the information had not been reported to the CEQI and UBCL committees. EMP2 and EMP3 stated "We were unaware of the 2015 returned reprocessed equipment until today."