HOSPITAL LOGO / ORGAN TRANSPLANT PROGRAMS
ADMINISTRATIVE POLICY

SUBJECT: Quality Assessment and Performance Improvement Policy

PURPOSE STATEMENT

The organ transplant QAPI Program at xxx Hospital 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

xxx Hospital 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 xxx Hospital.

RELATIONSHIP TO xxx HOSPITAL QAPI

The xxx 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 xxx 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 xxx organ transplant programs with national data

3.  Continuously tracking patient care and organization process outcomes in the organ transplant setting

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 xxx

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 xxx 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

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 xxx quality and safety committees

All PI projects requiring integration of multiple service lines or requiring resources beyond the service line will be approved by the xxx 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)

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

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 xxx Quality Department on a quarterly basis

14. Review performance metrics of contracted services – LIST CONTRACTED SERVICES HERE

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 at xxx.

Data is submitted or available to all of the following, but not limited to:

1.  OPTN/UNOS per OPTN and CMS guidelines

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

xxx 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.

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 xxx, 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

SLH 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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