ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
PURPOSE STATEMENT
The organ transplant QAPI Program at Hospital X has been established for the purpose of monitoring
financial, administrative and clinical data as well as providing a structured method of reviewing
unplanned events in organ transplant and living donor patient populations. The performance
improvement plan as designed by the organ transplant programs is devised to continuously ensure
quality patient care and service in a safe environment via continuous data collection, analysis, reporting
and action to monitor outcomes as related to operational processes while also identifying opportunities
for improvement.
POLICY
Hospital X will maintain a written, comprehensive, data- driven QAPI program to monitor and evaluate
performance of all organ transplant services, including those provided under contract or arrangement.
AFFECTED PROGRAMS
This policy applies to all organ transplant programs at Hospital X.
RELATIONSHIP TO HOSPITAL QAPI
The Hospital Quality Department establishes the format and methods of reporting and provides
umbrella oversight for transplant QAPI. The format for trending, reviewing and reporting data is the use
of dashboards and scorecard.
The PDMAI (plan, design, measure, analyze and improve) has been chosen as HOSPITAL
improvement structure.
PROGRAM DESIGN
The organ transplant quality program is designed around a bi-directional committee structure. All
clinical staff members in the organ transplant department are part of the quality improvement teams
and participate in quality activities. Support staff members participate on an ad hoc basis.
The Transplant Quality Manager will be responsible for monitoring of the transplant QAPI program.
PROGRAM GOALS AND OBJECTIVES
The goals and objectives of the organ transplant QAPI program are to assure safety and quality care
for transplant patients and living donors by:
1. Meeting or exceeding national benchmark or program developed goals on dashboard measures
2. Comparing outcomes in organ transplant programs with national data
3. Continuously tracking patient care and organization process outcomes in the organ transplant
setting
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
PAGE:
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ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
4. Providing consistent measurement, collection and analysis of data to drive improvements related
to quality and safety within organ transplantation
5. Assuring compliance with all internal hospital-wide quality indicators at Hosptial
6. Providing a continuous focus on improvement of patient care outcomes in organ transplantation
7. Observing zero adverse events as defined by CMS
a. Serious medical complications or death caused by living donation
b. Unintentional transplantation of organs of mismatched blood types
c. Transplantation of organs to unintended recipients
d. Unintended transmission of infectious disease to a patient
8. Identifying and investigating unplanned events within the organ transplant programs and making
recommendations for change in the delivery of care based upon multi-disciplinary review and
evaluation of these events
9. Ensuring patient safety and creating a culture in which employees involved in the care of organ
transplant candidates, recipients and living donors detect and help to correct unsafe systems as
part of their daily work responsibility
10. Assuring compliance with all external regulatory bodies, including but not limited to: the Organ
Procurement and Transplantation Network (OPTN), the United Network for Organ Sharing
(UNOS),Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (COP),
the Missouri State Department of Health (DOH), The Joint Commission (TJC) Standards
11. Ensuring the programs accreditation
12. Identifying opportunities for improvement
13. Prioritizing performance improvement and patient safety projects within organ transplantation
14. Continuously audit compliance and regulatory standards related to organ transplantation
15. Ensuring policies and procedures applicable to organ transplantation are evidence based,
regularly reviewed and audited for compliance
SCOPE
The organ transplant performance improvement plan will have a multi-disciplinary focus and will
influence all processes related to provision of care of organ transplant candidates, transplant recipients
and living donors during all phases of transplant related care, including the evaluation process, ongoing
treatment in both the inpatient and outpatient environment and long term follow-up post-transplantation
and living donation.
These processes include, but are not limited to, the following:
1. Patient referral
2. Evaluation of potential recipients and living donors
3. Waitlist management
4. Organ transplantation
5. Living donor surgery
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
PAGE:
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ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
6. Discharge planning of the transplant recipient and living donor
7. Follow-up and long term care of the transplant recipient and living donor
8. Quality improvement and patient safety projects
9. Patient satisfaction
10. Review of transplant related policies
11. Investigation of Adverse Events
12. Collaboration with regulatory agencies and payors
13. Reporting quality outcomes and process improvement project results to the Hospital squality and
safety committees
All PI projects requiring integration of multiple service lines or requiring resources beyond the CV
service line will be approved by the Senior Director of Quality.
QAPI COMMITTEES
Program-Level QAPI Committee
Each organ transplant program has a program level QAPI committee.
The program level QAPI committee meets a minimum of ten times per year and is co-chaired by the
Transplant Quality Analyst and the Program Clinical Nurse Manager. Minutes will be documented,
distributed and stored in the Transplant Quality folder on the department drive.
The activities and responsibilities of the program level QAPI committee are as follows:
1. Review of graft loss and patient death within one year of transplant
2. Use objective measures to evaluate the program’s performance
3. Review program dashboard quarterly – measures not meeting goals for two consecutive
quarters will generally result in a PI project
4. Final approval of policies and procedures related to their specific organ
5. Selection and completion of program related PI projects – minimum of one per program per year
6. Selection of annual CMS quality performance metrics
7. Monitoring of annual CMS quality performance metrics
8. Annual review of the performance improvement plan for their specific organ
9. Monthly review of projected outcomes analysis for their specific organ
10. Review of organ specific patient satisfaction reports
11. Review of new regulatory guidelines for their specific organ
12. Review of OPTN proposed guidelines for their specific organ
13. Review of issues/problems with departments involved in the care of patients for their specific
organ
14. Review of ongoing compliance, current and new audits
15. Report activities performed and key findings to the Transplant Performance Improvement
Steering Committee (TPISC)
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
PAGE:
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ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
Composition of the program-level QAPI Committee is as follows:
1. Transplant Quality Analyst, Co-Chair
2. Program Clinical Nurse Manager, Co-Chair
3. Transplant Surgery
4. Transplant Medicine
5. Statistician
6. Transplant Coordinator(s)
7. Transplant Administrator
8. Anesthesiologist, as needed or required by organ
9. Infectious Diseases physician, as needed
10. Transplant Social Worker
11. Mid-Level Providers
12. Transplant Pharmacist, as needed
13. Transplant Dietitian, as needed
14. Operating Room Representative, as needed
15. In-patient Nursing Representative, as needed
16. Transplant Financial Coordinator, as needed
17. Program support staff, as needed
18. Transplant Compliance RN
19. Transplant Quality Manager
Member attendance expectations are 80% of the meetings per year.
Transplant Performance Improvement Steering Committee (TPISC)
This committee performs oversight of the program-level QAPI committee.
The TPISC meets four times a year and is co-chaired by the Transplant Quality Manager and a
Transplant Medical or Surgical Director. Minutes will be documented, distributed and stored in the
Transplant Quality folder on the department drive.
The activities and responsibilities of the TPISC are as follows:
1. Review findings and recommendations from organ specific graft loss and patient mortality
reviews
2. Make recommendations for transplant center wide changes based upon the above reviews
3. Use objective measures to evaluate the program performances
4. Evaluate reports and data from program level QAPI committees, including dashboard metrics
requiring PI intervention
5. Selection and completion of at least one PI project per year that encompasses all programs
6. Final approval of policies and procedures related to all organ programs
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
PAGE:
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ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
7. Final approval of annual CMS quality performance metrics
8. Organization of quality initiatives
9. Prioritization of QAPI presentations
10. Recommendation of PI projects based upon data
11. Review of quality audit completion
12. Review of all programs SRTR outcomes
13. Report activities performed and key findings to the Quality Department on a quarterly basis
14. Review performance metrics of contracted services – Cardiac Anesthesia Associates, Westport
Anesthesia, Ameripath
Composition of the TPISC is as follows:
1. Transplant Quality Manager, Co-Chair
2. Physician/Surgeon Co-Chair
3. Medical Director from each program
4. Surgical Director from each program
5. Clinical Nurse Manager from each program
6. Transplant Administrator
7. Vice President of CV Product Line
8. Senior Director of Quality
9. Director, Strategic Business Development
10. Anesthesiologist, MOR
11. Liver Anesthesia Director, CVOR
12. Chief Nursing Officer
13. Clinical Pharmacy Coordinator
14. Physician Director of Critical Care
15. Infectious Diseases Liaison to transplant
16. Transplant Quality Analysts
17. Transplant Compliance RN’s
Member attendance expectations are 75% of the meetings per year.
DATA REPORTING
The timely collection and reporting of data to internal and external audiences is considered a quality
function for the organ transplant programs.
Data is submitted or available to all of the following, but not limited to:
1. OPTN/UNOS per OPTN and CMS guidelines
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
PAGE:
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ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
2. Insurance companies per contract
3. The Joint Commission, CMS or UNOS when requested as part of the regulatory process
SRTR data is reviewed prior to being released to the public.
Data dictionaries are maintained for all data elements required for submission.
Routine data entry and data submission audits are performed and reported within the audit reports to
each organ transplant quality committee.
PATIENT/FAMILY INPUT
This hospital uses HCAPS and an internally developed patient satisfaction survey. Scores and
comments from the in-patient nursing floors where transplant patients are housed are reviewed.
Outpatient customer satisfaction scores and comments are also reviewed.
Verbal feedback from patients/families to transplant team members is shared with the team and
addressed as appropriate.
ADVERSE EVENTS
Adverse event means an untoward, undesirable and usually unanticipated event that causes death or
serious injury, or the risk thereof.
As applied to organ transplant programs, examples of adverse events include, but are not limited to, the
following:
1. Serious medical complications or death caused by living donation
2. Unintentional transplantation or organs of mismatched blood types
3. Transplantation of organs to unintended recipients
4. Unintended transmission of infectious disease to a recipient
As soon as an adverse event is identified, the event will be reported to the program specific clinical
nurse manager, transplant administrator or the program medical and surgical directors, who will then in
turn report the event to risk management.
Adverse events will be investigated, documented in the incident reporting system and reported as
applicable with risk management direction and oversight using the current hospital model for such
events.
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
PAGE:
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ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY
SUBJECT: Quality Assessment and Performance Improvement Policy
The risk management department will make post-event recommendation to TPISC, who will in turn be
responsible for implementation, documentation and auditing of these recommendations.
If the event is suspected to be donor related, the program medical or surgical director will report the
event to the Organ Procurement Organization (OPO) where the organ originated.
External reporting of events to appropriate agencies including, but not limited to OPTN, ESRD Network,
State of X, FDA, and/or CDC will be performed by risk management in partnership with transplant
administration.
Communication with agencies to whom the event is reported will be multidirectional.
REFERENCES
CMS Conditions of Participation - Organ Transplant Surveys, Interpretive Guidelines
CMS Memorandum Summary October 24, 2008 – Page 5 – 2060B-1 – Adverse Events
Hospital Administrative Guidelines – Incident Reporting
Yearly PI Projects
Transplant Program Dashboards
Transplant Program Audits
THIS POLICY ADDRESSES THE FOLLOWING CMS CONDITIONS OF PARTICIPATION:
482.96
Tag X099
Tag X100
Tag X101
Tag X102
Tag X103
Tag X104
ISSUED BY: TRANSPLANT ADMINISTRATION
EFFECTIVE DATE: 11/2012
SUPERCEDED EFFECTIVE DATE: NEW POLICY
APPROVED BY: TRANSPLANT PERFORMANCE IMPROVEMENT STEERING COMMITTEE
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