COLLABORATION Franklin W. Maddux, M.D.,FACP March 16, 2011 3/16/2011A renal community collaboration C C Q Creating a Culture of Quality

COLLABORATION

Franklin W. Maddux, M.D.,FACPMarch 16, 2011

3/16/2011 A renal community collaboration

CCQCreating a Culture of

Quality

Disclosure StatementFranklin 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 TrusteesA renal community collaboration3/16/2011


Quality

My Collaborators on Collaboration

• Jenny KitsenJenny Kitsen– ESRD Networks– Collaboration is at the heart of Network activity

• Judith Kari, MSSW, ACSW, LICSWJudith Kari, MSSW, ACSW, LICSW– CMS– Survey and Certification Collaboration enables all access to care

• Gina Randolph, RN,MSN,MBAGina Randolph, RN,MSN,MBA– DaVita– Collaboration central to addressing the number 1 clinical issue - Catheters

• Denise VanValkenburgh, BA, RN,CNN,CPHQDenise VanValkenburgh, BA, RN,CNN,CPHQ– Liberty Dialysis– How collaboration will help us deal with Healthcare Associated Infections



Quality

Patient Safety and Quality Improvement Act

• PL-109-41 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: To Err is Human: Building a Safer Health SystemBuilding a Safer Health System” ”

• Goal of the Act is to improveimprove 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



Quality

How?

• Allows health care providers to submit patient adverse event data to a PPatient SSafety OOrganization

• Designate that information as privileged, “PPatient SSafety WWork PProduct”

• Deem the entire structure and all communications part of a confidential PPatient SSafety EEvaluation SSystem



Quality

What is a Patient Safety Organization?

A PSO is an organization dedicateddedicated to improving patient safety & quality of care by:

– Collecting, aggregating, and analyzing confidential informationinformation

– Exploring all possible root causesroot causes

– Identifying patternspatterns of failures

– Making recommendationsrecommendations for improvements to providers


Fresenius created a PSO dedicateddedicated 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



Quality

Adverse Event Documentation & Analysis

QAI Committee Performs Facility

RCA

PSO Performs

System wide analysis

Medical Record

QAI Log PSO MDR

An Adverse Event


QAI – PSODistinctive 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



Quality


Quality

Patient Safety Act:

• ProhibitsProhibits 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”

• However, creation of a PSO does not relievedoes not relieve provider from state and regulatory obligations

• Need to create 2 Tracking Systems2 Tracking Systems to support– QAPI– PSO



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 processesFacilities will meet Conditions for Coverage via QAI processes– Surveyors are not entitled to the aggregated analysis under PSWPSurveyors are not entitled to the aggregated analysis under PSWP



Quality

The Collaboration Panel

• Jenny KitsenJenny Kitsen– ESRD Networks– Collaboration is at the heart of Network activity

• Judith Kari, MSSW, ACSW, LICSWJudith Kari, MSSW, ACSW, LICSW– CMS– Survey and Certification Collaboration enables all access to care

• Gina Randolph, RN,MSN,MBAGina Randolph, RN,MSN,MBA– DaVita– Collaboration central to addressing the number 1 clinical issue - Catheters

• Denise VanValkenburgh, BA, RN,CNN,CPHQDenise VanValkenburgh, BA, RN,CNN,CPHQ– Liberty Dialysis– How collaboration will help us deal with Healthcare Associated Infections


Documents

COLLABORATION Franklin W. Maddux, M.D.,FACP March 16, 2011 3/16/2011A renal community collaboration C C Q Creating a Culture of Quality