Transplant Quality Assurance & Performance Improvement
Plan (QAPI)
2015
Adult Liver, Adult Kidney (including Living Donor), Adult Kidney-Pancreas, Adult Pancreas (TNMH)
Pediatric Liver, Pediatric Kidney (TNLB)
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PART 1. TRANSPLANT QAPI PROGRAM INFORMATION
The Transplant Quality Assurance and Process Improvement Plan at Methodist Le Bonheur Healthcare (MLH)
oversees the quality management of the transplant program and the safety of transplant candidates and
recipients across the continuum of care. This quality assurance plan is based on the United Network Organ
Sharing (UNOS) Policies and bylaws, Centers for Medicare and Medicaid Services (CMS) Conditions of
Participation (CoP) for Transplantation, Joint Commission Standards and addresses three main components:
 Quality Assessment
 Process Improvement
 Root Cause Analysis
This (QAPI) Plan describes organization and structure of the Transplant quality assurance system of Methodist
Le Bonheur Healthcare (MLH) and serves as a guidance document for each member of the transplant staff. To
evaluate the effectiveness of process improvements, a formal resource utilization process is needed. The use of
MLH data, published multicenter reports, published standards of care, AHRQ clinical guidelines/systematic
reviews, and SRTR outcomes are examples of sources by which transplant programs may benchmark transplant
program data and identify best practices for streamlining workflow, improving clinical outcomes and reducing
the costs associated with care of complex patient populations.
Quality Components
 Clinical outcomes
o Pre transplant
o Perioperative
o Post transplant
 SRTR outcomes
 Compliance with regulatory standards
 Patient safety
 Patient satisfaction
 Resource utilization
 Data management and analysis
Objectives:
1. Continuous focus on improvement of patient care outcomes
a. Compare outcomes with national data
b. Track patient care and organizational process outcomes
c. Ensure patient safety in the ambulatory care setting
d. Maintain staffing levels that are appropriate for the acuity of specific patient group
e. Ensure clinical staff members are effectively trained to carry out their work competently and
provided with opportunities for continuous professional education
f. Prioritize performance improvement based patient outcomes and patient safety projects
g. Ensure health and safety measures are enforced
2. Evaluate patient satisfaction with transplant processes
a. Ensure patients and families are well informed about the transplant process with its risks and
benefits and feel confident about their treatment and care.
3. Ensure policies and procedures are evidence based, regularly reviewed and audited for compliance
4. Audit compliance with regulatory standards
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PART 2. QAPI DESIGN AND SCOPE
Design
The Transplant QAPI Plan outlines the design and scope of the transplant QAPI process, identifies governance
and leadership of the program, describes the process for feedback, methods for data collection and monitoring,
and addresses the program’s process for root cause analysis. The QAPI Plan describes the committee structure,
frequency of meetings, methods for collecting and analyzing data as well as reporting processes. The
Transplant QAPI Plan ensures compliance to national standards for the United Network Organ Sharing (UNOS)
policies and bylaws, Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (CoP) for
Transplant, the Tennessee Department of Health (DOH), The Joint Commission (TJC) Standards, and internal
quality indicators as deemed by the hospital
The transplant QAPI program has been designed as an adjunct to the institutional QAPI plan with the goal of
maintaining excellent outcomes for transplant candidates and recipients. The Plan defines the responsibilities
and tasks necessary to meet patient safety standards and to verify that those standards have been met. Transplant
QAPI data reflecting patient outcomes and process improvement findings are reported annually to the hospital’s
Quality Committee of the Board. Transplant specific policies and procedures reflect regulatory structure and
are developed to ensure optimal patient outcomes. Policies and procedures are reviewed at least every five years
and updated to include the most current evidence in clinical practice. The QAPI program is multidisciplinary
with participation by transplant physicians, surgeons, coordinators, advanced practice nurses, social workers,
pharmacists, dietitians and staff involved in direct patient care. A steering committee, The Transplant Institute
Executive Council (TIEC), oversees the organ specific transplant QAPI committees and collaborates with each
committee to determine performance measures to be tracked and analyzed.
Scope
The QAPI Plan will influence processes related to provision of care to patients during the evaluation process,
transplant surgery, and follow up post transplantation. These processes may include:
•
Patient referral
•
Evaluation of patients
•
Patient and family education throughout the phases of transplantation
•
Presentation of candidates at patient selection committee meetings
•
Waitlist management
•
Organ transplantation
•
Discharge planning
•
Follow up and long term monitoring of recipients and living donors
•
Provision of staff education
•
Process improvement and patient safety projects
•
Patient satisfaction
•
Review of policies for approval
•
Investigation of adverse events
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Collaboration with regulatory agencies and insurers
Reports on quality outcomes and process improvement project results will be submitted and/or presented to the
hospital’s quality and/or safety committees as well as to patient care area staff such as the Intensive Care Units,
Operating Room and step down units.
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3. GOVERNANCE AND LEADERSHIP
The Methodist LeBonheur Hospital Administration assigns one representative from the hospital QAPI
department as a resource for the transplant program. The representative provides guidance as needed for
various aspects of the transplant QAPI process, and ensures the hospital’s QAPI program is shared with
Transplant. The transplant QAPI program presents data to the hospital QAPI leadership and hospital
administration to ensure they remain aware of activities and outcomes in the transplant program. Transplant
QAPI reports and minutes are provided to the hospital QAPI and administrative teams. Hospital administration
provides resources in terms of personnel, space and equipment such as computers and software to maintain the
transplant QAPI program. A member of the transplant staff serves on the hospital QAPI committee to ensure
that information is communicated from the hospital QAPI to transplant QAPI as well as from transplant to
hospital QAPI programs.
The Transplant TIEC is responsible for oversight of the QAPI processes in the transplant program and ensures
reporting to the hospital’s QAPI Committee. The TIEC membership includes leadership of the transplant team.
TIEC Committee
 Director of Transplantation
 Transplant Administrator
 Program Medical Directors
 Director of Clinical Operations/Program Manager
 Director of Transplant Quality
TIEC Committee’s Oversight Role (governance) Related to QAPI
The TIEC Committee
 Meets at least twice yearly and maintains minutes from each meeting
 Evaluates organ specific quality reports and data
 Provides final approval to process improvement projects for the transplant program
 Review of Policies and Procedures
 Ensures policies and procedures are evidence based
 Delegates specified policies and procedures to users for oversight and to ensure appropriate
implementation
 Requests development of new policies to reflect new regulations or change in practices
 Reviews proposed and revised policies and procedures
 Ensures policies and procedures are archived
 Reviews Transplant QAPI Plan annually
 Oversight for all QAPI activities in the Clinical Program
 Oversees day to day quality improvement activities
 Allocates resources
 Recommends and prioritizes process improvement projects
 Approves all performance indicators in organ specific scorecards
 Reviews SRTR outcomes as released on secure site
 Reviews CUSUM reports
 Participates in investigation of Adverse Events and directs further review.
 Reviews corrective action plans for Root Cause Analyses
 Reviews corrective action plans for UNOS and CMS if indicated
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
Reviews adverse events and near misses
Reviews and maintains written agreements with third parties
o Ensures third party QAPI is released to transplant program
Establishment and maintenance of written agreements with third parties
The TIEC Committee is also responsible for oversight of current contracts with third party agencies such as
suppliers related to organ procurement, transplant database, the HLA laboratory and transportation services for
organ procurement. Suppliers of products or services that can affect the quality of service are evaluated and
selected based on their ability to supply in accordance with specified requirements. Contracted parties must
provide the transplant program with their QAPI outcomes based on elements outlined in the agreement.
Organ Specific Transplant QAPI Teams:
Organ specific meetings provide opportunities for staff to ensure that the patients receive appropriate treatment
and monitoring in line with the QAPI Plan and established policies and procedures. Any suggested changes to
policies and procedures are presented to the QAPI Committee for discussion and approval. The Transplant
QAPI Team members are responsible to report on their assigned activities with process improvement projects
at team QAPI meetings.
Roles for members of this committee include:
 Presenting process improvement projects to the TIEC Committee for approval
 Implementing process improvement projects based on problems identified or areas of concern identified
by members of the team.
 Discussing clinical practice changes that may improve patient outcomes
 Presenting updates on policies and procedures to the TIEC for approval
 Collecting and analyzing data
 Presenting analyzed data to the committee on a monthly basis
 Maintaining minutes from each meeting.
 Membership to organ specific QAPI meetings includes the following:
 TIEC Committee members
 Social Worker
 Clinical Dietitian
 ICU unit representative
 Transplant unit staff RN/APN
 OR staff representative
 Anesthesiologist
 Pharmacist
 Unit Case Managers
 Financial Coordinator
 Transplant Coordinator
 Consultants from Infectious Disease, Pathology, HLA lab, and specialty services as required to address
specific patient problems.
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PART 4. FEEDBACK, DATA SYSTEMS AND MONITORING
The transplant program monitors care and services, drawing data from multiple sources. Feedback systems
actively incorporate input from staff, patients, families and hospital departments with which the transplant
program interacts. This element includes using Performance Indicators to monitor a wide range of care
processes and outcomes, and reviewing findings against benchmarks and/or targets the facility has established
for performance. Data are analyzed monthly (quarterly for pediatric programs) and reported to the specific
QAPI committees. Feedback systems and monitoring includes tracking and investigating Adverse Events when
they occur. Data from action plans that have been implemented to prevent recurrences of adverse events are also
included in regularly scheduled reports to the QAPI committees.
The QAPI manager and data coordinators are responsible for collecting data, analyzing the data and reporting it
on a monthly basis to each committee (quarterly for pediatric programs). A statistician may be consulted to
perform more in depth analysis of data. The QAPI manager is responsible for ensuring the accuracy of data.
The SRTR data reports are reviewed with the TIEC Committee and/or QAPI Committee as released on the
secure site twice a year. CUSUM reports are reviewed at regularly scheduled meetings with the QAPI
Committees.
Performance indicators are identified and reviewed annually by the QAPI TIEC Committee with specific
emphasis on promoting safe, effective care and outcomes that equal or excel national benchmarks or internal
trends. Data related to performance measures are collected, trended and reported to the appropriate committees.
QAPI data, elements of corrective action plans, audit reports, outcomes of Causal Analysis or departmental
investigation provide opportunities for developing performance measures to be tracked.
Benchmarks are included in QAPI scorecards from resources such as:
 AHRQ clinical guidelines or systematic reviews
 Evidence based on systematic reviews or meta analysis
 Clinical guidelines for transplant candidates and recipients
 SRTR national and program specific reports
Quality Focus for 2015
Examples of areas for specific transplant quality focus in 2015 include patient safety and regulatory compliance.
Performance indicators are reviewed annually by the TIEC Committee for each program, and may include any
of the following:
Transplant process
 Pre transplant
a. Structure and process for waitlist management
b. Two ABOs checked prior to listing
c. Data are entered into UNet in a timely manner
d. Informed consent for evaluation is obtained from each candidate being evaluated
e. Letters are sent to candidates within 10 days of listing or de listing.
f. Quality of data entry
 Perioperative
a. ABO and UNOS ID verification intra-operatively
b. Ischemic time
c. Discharge Planning
d. Medical complications
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e. Surgical complications
f. Unplanned return to the OR during transplant admission
g. Length of stay/ Readmission rates
 Post operative follow up
a. Patient and graft survival
b. Rejection rate
c. Infection
d. Patient satisfaction in ambulatory care setting
Living Donor
Pre donation
 Medical and psychosocial evaluation is documented in chart
 Informed consent is documented during the evaluation process
 Living donor advocate documents assessment prior to presenting patient at selection meeting
 Review of increased risk behaviors
Donation
 Length of stay
 Medical complications
 Surgical complications
 Return to the OR required
Post donation
 Documentation of follow up visits at
o 1 month
o 6 months
o 1 year
o 2 years
 Documentation of follow up visits includes:
o Blood pressure
o Serum creatinine
o Return to work
Patient satisfaction – This is assessed in a variety of ways:
a. Complaints - processed through the Patient Relations Department. A summary of complaints is fed back
at the Monthly Staff meetings to identify any necessary corrective actions
b. Patient satisfaction surveys
c. A log of all patient complaints is maintained in the Patients Relations Department and provided to
hospital QAPI as requested.
PART 5: PERFORMANCE IMPROVEMENT ACTIVITIES
The QAPI teams develop process improvement projects that focus on high risk, high or low volume activities
and areas that are prone to problems and scrutiny. Each process improvement project is conducted with
members representing the various disciplines on the transplant team and at least one member of TIEC whenever
possible. The rationale for selection of each process improvement project is documented in the minutes of the
QAPI meeting. Data collected should be analyzed and demonstrate evidence of sustainable changes in
practice.
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Performance improvement projects are approved by the TIEC Committee. Data are defined and analyzed to
determine progress. Minutes of meetings are maintained and processes are documented. Data are tracked after
completion of the project to demonstrate sustained improvements.
Methods used to improve quality performance may include:
 Plan Do Study Act (PDSA)
 Focus Analyze, Develop and Execute (FADE)
 Six Sigma
 Define Measure Analyze Improve Control (DMAIC)
 Failure Mode and Effects Analysis (FMEA)
Instruments used for capturing and documenting data may include:
 Flow charts
 Check sheets to collect data
 Process Mapping
 Control charts
 Fishbone diagram
 Pareto diagram
PART 6: ADVERSE EVENT (AE)
The transplant program recognizes the need for immediate thorough investigation to be conducted when certain
events occur such as adverse or sentinel events. To address the need for immediate investigation the Transplant
Institute Executive Committee or Chairs of organ specific QAPI committees may authorize certain individuals
to act as investigators for the committee. These investigators shall review events and report to the next
scheduled committee meeting. The program’s adverse event policy follows the institution’s adverse events
policy and also identifies transplant specific adverse events. Reports from the investigation, including Root
Cause Analysis if indicated, for each adverse or sentinel event are provided to the Transplant TIEC Committee
as well as to the institution’s Quality Committee of the Board when appropriate.
All staff are provided with education on how to report adverse events. Adverse event reporting is part of each
staff member’s orientation. A thorough investigation and, if indicated, Causal Analysis is completed using
methods outlined by the institution’s and the Transplant program’s adverse events policy. In addition, a time
line may be utilized, providing the transplant team with possible factors that may have impacted on the
outcome, from pre transplant, perioperative and post-transplant periods. Each investigation is conducted by the
chairs of the organ specific QAPI program, the Director of Transplant Quality, or the designated hospital leader
representing Hospital Quality when appropriate. Tools such as Cause and Effect charting, fishbone diagram
and 5 whys may be used to explore the root cause of a problem. Reports of the investigation and the corrective
action plans are presented to the Transplant TIEC Committee. The corrective action plan addresses actions
taken to prevent similar adverse events, the method for tracking and evaluating actions taken. A log of adverse
events is maintained in the transplant QAPI office and is shared with the institution leadership as requested.
Detecting, evaluating, documenting, and reporting errors, accidents, suspected adverse
events, deviations, and complaints
All members of the Transplant Institute team are responsible for detecting and reporting potential problems,
deviations and/or undesirable incidents, as rapidly as possible. Deviations shall be reported immediately to the
QAPI manager, transplant administrator or a member of the TIEC Committee.
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A deviation and/or undesirable incident is defined as:

Any adverse event as defined by the Transplant Adverse Event policy

Graft Loss within first year post transplantation

Death within first year post transplantation

Serious complication or death caused by the transplant process

Unintentional transplant of organs of mismatched blood type

Organ transplanted into an unintended recipient

Unintended transmission of infectious disease to a recipient

An occurrence that deviates from accepted policy or procedure, even if no harm occurred
Any life threatening or potentially life-threatening event shall be reported immediately to Chairperson of the
TIEC Committee
Tools used to assist in the analysis of an adverse event include:
 Time line leading to the adverse event or near miss
 Fishbone diagram/ cause and effect diagram
 5 Why’s
Confidentiality
All information, reports, statements, or other data that serve or are the outcome of the quality improvement
process shall be considered privileged and strictly confidential in their entirety. Such materials shall be used
only for the evaluation and improvement of organizational processes and patient care. The above fall within the
privilege status and are free from discovery and shall not be admissible as evidence.
Approvals
Date
Clinical Director, Transplant Institute
Date
Program Director, Transplant Institute
Date
Director of Transplant Quality
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