COLLABORATION Franklin W. Maddux, M.D.,FACP March 16, /16/2011A renal community collaboration C C Q Creating a Culture of Quality

Disclosure Statement Franklin W. Maddux, M.D., FACP Employment – Fresenius Medical Care North America – Chief Medical Information Officer – Senior Vice President Board and Directorships – Renal Physician Association Board of Directors – Mid Atlantic Renal Coalition Board of Directors – American National Bank & Trust (NASDAQ:AMNB) Board of Directors Chairman, Audit Committee, Governance Committee – Averett University Board of Trustees A renal community collaboration3/16/2011 C C Q Creating a Culture of Quality

My Collaborators on Collaboration Jenny Kitsen Jenny Kitsen – ESRD Networks – Collaboration is at the heart of Network activity Judith Kari, MSSW, ACSW, LICSW Judith Kari, MSSW, ACSW, LICSW – CMS – Survey and Certification Collaboration enables all access to care Gina Randolph, RN,MSN,MBA Gina Randolph, RN,MSN,MBA – DaVita – Collaboration central to addressing the number 1 clinical issue - Catheters Denise VanValkenburgh, BA, RN,CNN,CPHQ Denise VanValkenburgh, BA, RN,CNN,CPHQ – Liberty Dialysis – How collaboration will help us deal with Healthcare Associated Infections 3/16/2011A renal community collaboration

C C Q Creating a Culture of Quality Patient Safety and Quality Improvement Act “To Err is Human: Building a Safer Health System” PL was signed into law July 29, 2005 in response to a growing concern about patient safety and in response to the Institute of Medicine’s 1999 report, “To Err is Human: Building a Safer Health System” improve Goal of the Act is to improve patient safety by: – Fostering a culture of patient safety – Encouraging voluntary reporting of adverse events – Establishing a new, federal legal privilege and confidentiality – Eliminating the fear of information being used against the provider in litigation or disciplinary proceedings 3/16/2011A renal community collaboration

C C Q Creating a Culture of Quality How? PSO Allows health care providers to submit patient adverse event data to a Patient Safety Organization P SWP Designate that information as privileged, “Patient Safety Work Product” PSE S Deem the entire structure and all communications part of a confidential Patient Safety Evaluation System 3/16/2011A renal community collaboration

C C Q Creating a Culture of Quality What is a Patient Safety Organization? dedicated A PSO is an organization dedicated to improving patient safety & quality of care by: information – Collecting, aggregating, and analyzing confidential information root causes – Exploring all possible root causes patterns – Identifying patterns of failures recommendations – Making recommendations for improvements to providers 3/16/2011A renal community collaboration

dedicated Fresenius created a PSO dedicated to improving patient safety & quality of care for those with renal disease : Develop consistent root cause analysis Encourage reporting of AEs Avoid repeat AEs Develop Best Practices Make recommendations for improvements to providers Develop methods of analyzing root causes of very rare events of high consequence Collect, aggregate, and analyze confidential information reported by dialysis service providers Have a more structured way of communicating “lessons learned” throughout the company Identify trends and patterns –Analyze specific types of Adverse Events (“AEs”) –Obtain expert opinions and advice 3/16/2011A renal community collaboration

C C Q Creating a Culture of Quality Adverse Event Documentation & Analysis QAI Committee Performs Facility RCA PSO Performs System wide analysis Medical Record QAI Log PSO MDR An Adverse Event 3/16/2011A renal community collaboration

QAI – PSO Distinctive Activities QAI is performed at the facility level as required by Conditions for Coverage QAI is an independent process from the PSO analyses QAI is not confidential from surveyors  Information reported to PSO is done on a parallel track from the facility’s own analysis  Information reported to PSO is same factual information reported to QAI PSO collects data from multiple facilities PSO conducts independent analysis at “macro” level PSO material is confidential and privileged PSO has the scope to analyze root causes for rare events by having access to multiple facilities 3/16/2011A renal community collaboration C C Q Creating a Culture of Quality

C C Q Patient Safety Act: Prohibits Prohibits PSWP from being shared with surveyors – “Survey and licensure bodies are not accrediting bodies and are not treated as such under this provision. Thus, such entities are not entitled to receive patient safety work product voluntarily from providers under this provision” does not relieve However, creation of a PSO does not relieve provider from state and regulatory obligations 2 Tracking Systems Need to create 2 Tracking Systems to support – QAPI – PSO 3/16/2011A renal community collaboration

C C Q Creating a Culture of Quality Quality Collaboration with CMS Fresenius PSO has been certified by AHRQ following extended analysis by AHRQ and the FDA Notified CMS in September 2009 of intent to create PSO Worked with CMS to ensure new system was understood by all parties – a goal of no surprises Have asked CMS to provide guidance to surveyors of change in processes with the advent of the PSO – Facilities will meet Conditions for Coverage via QAI processes – Surveyors are not entitled to the aggregated analysis under PSWP 3/16/2011A renal community collaboration

C C Q Creating a Culture of Quality The Collaboration Panel Jenny Kitsen Jenny Kitsen – ESRD Networks – Collaboration is at the heart of Network activity Judith Kari, MSSW, ACSW, LICSW Judith Kari, MSSW, ACSW, LICSW – CMS – Survey and Certification Collaboration enables all access to care Gina Randolph, RN,MSN,MBA Gina Randolph, RN,MSN,MBA – DaVita – Collaboration central to addressing the number 1 clinical issue - Catheters Denise VanValkenburgh, BA, RN,CNN,CPHQ Denise VanValkenburgh, BA, RN,CNN,CPHQ – Liberty Dialysis – How collaboration will help us deal with Healthcare Associated Infections 3/16/2011A renal community collaboration