UNOS Compliance Experience

1
UNOS Compliance Experience

• Celebrating our Partners
• 3rd Annual Donation and Transplantation
  Conference
• One Legacy
• June 6, 2007
• Debra Maurer, Administrator, Transplant Center

2
From Crisis to Correction

• Liver case was a terrible ethical and regulatory
  breach
• Breakdown in accountability and institutional
  oversight
• Severe damage to the hospitals reputation,
  finances and morale lead to closure of heart
  transplant program
• Revealed silo mentality
• With corrective actions, we have reclaimed the
  transplant center and created a new culture of
  accountability and transparency

3
A complete transformation

• Institutional Redesign
• Transplant Center fully integrated into hospital
  operations and management structure, including
  formation of Transplant Committee which reports
  into Medical Executive Committee and Board of
  Directors
• New personnel at all leadership levels hospital
  and system leaders are actively informed and
  involved in transplant center
• Redesign of the transplant center supports
  accountability, integration and compliance with
  all regulatory agencies (UNOS, JCAHO, CMS and CA
  DHS)
• Enhanced systems, oversight, audits and processes

4
Physicians as accountable partners

• Defined roles, responsibilities, reporting
  relationships, levels of authority and lines of
  accountability
• Medical Executive Committee, as a part of checks
  and balances in the organization, has concurrent
  oversight of MOTC operations, outcomes and
  quality improvement
• Full consultation with Medical Executive
  Committee on closure of heart transplant program

5
A culture of accountability

• Program Director, Administrator and VP Quality
  reviewing all match runs for organ offers for
  deceased donor transplants
• Revised internal policy to limit access to UNet
  database only to appropriate users
• Reviewed/revised all internal policies related to
  transplant data collection and submission
• Monthly reports on key metrics and audit results
  being submitted to Transplant Committee for
  oversight and monitoring

6
A culture of transparency

• Hospital-wide ethics training liver incident is
  incorporated into Compliance training for new
  hire orientation and annual training
• St. Vincent Quality Department actively auditing
  transplant data and processes on monthly basis
  checks and balances are in place
• Pre transplant audit includes assessing
  compliance with UNOS bylaws and policies such as
  ABO verification prior to listing, listing letter
  within 10 days and ABO verification prior to
  transplant procedure
• Post transplant audit includes assessing
  compliance with removal within 24 hours and
  verification of Operative report with UNet data
• Transplant specific Quality program with metrics
  incorporated on St Vincent Medical Center Quality
  Dashboard

7
Communication

• Constant and on-going with all regulatory
  agencies UNOS, JCAHO, CMS and CA DHS as well as
  cooperation with surveys and audits
• Internally to associates and medical staff on
  progress being made, status of UNOS approved
  Corrective Action Plan including monthly report
  to Hospital Board of Directors and as well as
  System Board
• Patients and their families Per UNOS Bylaws
  required to notify all patients on the CASV
  waiting lists when Member Not in Good Standing
  action was taken. In March 2006, 1165 letters
  mailed to patients on the CASV heart, kidney and
  pancreas waiting lists
• Consistent updates and clarifications to
  Customers (referral sources including payors) on
  status of programs can we do transplants and
  updates on implementation of corrective action
  plan

8
UNOS Resources available

• OPTN Evaluation Plan- updated March 2007
• Audit results of routine surveys performed by
  UNOS Evaluation and Quality department
  involvement of Hospital quality department
• Improving patient safety on line reporting
  system for safety situation, live donor adverse
  event and/or proposed best practice
• UNOS staffing survey
• 888-894-6361 toll free patient services line
• 866-787-4909 reporting hotline for transplant
  professionals

9
Where we are now

• Initial liver transplant issue has caused damage
  to the hospital that will never be repaired
  including closure of the heart transplant program
  in October 2006
• UNOS approved Corrective Action Plan in June
  2006 monthly submission of reports to MPSC and
  completion of unannounced site survey in March
  2007
• We have taken accountability and responsibility
  and remain committed to providing excellent
  quality and compassionate care to our patients
  and their families

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