Quality Assurance and Performance Improvement (QAPI) and Regulatory Issues in Transplantation: A New Focus in Transplantation
Linda Ohler, RN, MSN, CCTC, FAAN
Samira Scalso de Almeida, RN, MS
Karina Dal Sasso Mendes, RN, PhD
Luciana Carvalho Moura, RN, MS, MBA(c)
I. INTRODUCTION1A. Since the first successful kidney transplant by Dr. Joseph Murray in Boston in 1954, advances in solid organ transplantation have resulted in lifesaving procedures for individuals with end-organ diseases.1
B. Historical perspective:
Starzl and colleagues performed the first successful liver transplant in the United States in 1967.
The heart transplant procedure was developed by Shumway and Lower in the mid-1960s. These initial heart transplants were in dogs, and interestingly, some of the transplant dogs went on to have puppies.
However, the first successful human heart transplant was performed by Dr. Christian Barnard in 1967 who studied under Lower and Shumway. Barnard had spent time with Dr. Lower in 1967 and learned the surgical technique for this procedure. He is credited with the first successful heart transplant, which he performed upon his return to South Africa.
Cooper and colleagues performed the first successful lung transplant in Toronto, Canada, in 1983.
During these early years, there was very little oversight of the allocation of organs.
C. The foundations for transplantation in the United States were established when Congress passed the National Organ Transplant Act (NOTA) in 1984.2
This act established the Organ Procurement Transplantation Network (OPTN), which required
A national registry for organ matching, which would be operated by a private, not-for-profit organization:
The United Network for Organ Sharing (UNOS) has been awarded the OPTN contract for organ allocation and waiting list registry since 1986.
Public release of program-specific information regarding the performance of transplant programs:
This requirement is accomplished through an OPTN contract with the Scientific Registry of Transplant Recipients (SRTR) that was established in 1987.3
Each transplant program in the United States submits required data on transplant candidates and recipients to UNOS through a secure portal.
These data are aggregated and sent to the SRTR for analysis.
Following analysis, SRTR releases the data publicly via their Web site: www.srtr.org.3 These data include applicable program-specific, local, and national data relative to:
Waitlist information such as
Characteristics of waitlisted patients
Transplant and mortality of waitlisted patients
Percent transplanted, waitlisted patients
Time to transplant, waitlisted patients
Recipient characteristics: deceased and living donors
Donor characteristics: deceased and living donors
Transplant operation characteristics
Patient survival
Graft survival
II. EVOLUTION OF REGULATORY OVERSIGHTA. Oversight for performance of transplant programs based on outcomes and quality was not fully established in the United States until 2007 when the Centers for Medicare and Medicaid Services (CMS) issued the Conditions of Participation (CoPs) for transplant programs.4
B. With the release of the CoPs, every transplant program in the United States was required to submit a letter to CMS indicating the program’s commitment to follow the new CoPs. This was the beginning of the linkage of Medicare payment to data-driven outcomes as well as standardized regulations in transplantation.
C. Initially, there were doubts in the transplant community that these new regulations and outcome expectations would or could be upheld by CMS.
D. As the SRTR began to release data twice annually, patient and graft survival outcomes were being scrutinized by public (CMS) as well as private insurers.
E. CMS began site surveys of transplant programs in 2007 to evaluate adherence to the newly released CoPs.
Regulatory on-site surveys from CMS occur every 3 to 5 years without notification to transplant programs, much like The Joint Commission hospital surveys.
Transplant programs must be ready at all times for a site survey that may continue for 2 to 5 days, depending on the size of the transplant program.
If deficiencies are identified, the transplant program must develop a corrective action plan to improve program compliance with CMS standards.
Additionally, data reflecting program changes stipulated in the corrective action plan must be tracked and reported to demonstrate positive results and sustainability of processes or outcomes.
F. Implementation of the CMS CoPs has resulted in most transplant programs adding personnel such as quality and regulatory managers, clinicians, and data managers to ensure adherence to the structured oversight.
G. In addition to the structure and personnel necessary to meet expectations, the CoPs stipulate organ-specific volume requirements as well as expectations regarding patient and graft survival outcomes.
Programs that report statistically lower than expected outcomes in two of the last five SRTR releases are likely to receive a notification from CMS that they are at risk of losing Medicare reimbursement unless they can demonstrate improvements in their outcomes.
If the progress toward better outcomes is not satisfactory to CMS, a transplant program may enter into a probationary period with a systems improvement agreement (SIA) issued by CMS.
SIA process:
An independent peer review team consisting of an interdisciplinary group of transplant professionals is directed by CMS to conduct on-site survey of the transplant program.
A report of recommended corrective actions is submitted to the transplant program and conveyed verbally to CMS.
Transplant programs are given 8 to 12 months to make the required improvements to meet expected outcomes.
During an SIA, a transplant program is required to hire consultants to assist with implementation of a corrective action plan that has been reviewed and approved by CMS officials.
Monthly calls are conducted with the consultants, CMS (national and regional), and the transplant program on probation.
Updates on progress are assessed through a review of the transplant program’s performance improvement projects and data.
Programs are released from the SIA based on demonstration of improvements and completion of their corrective action plans.
H. UNOS surveys of regulatory requirements:
UNOS began site surveys to evaluate transplant programs for compliance with UNOS policies and data integrity in 2006.
In 2009, UNOS began to survey transplant programs with living donor programs to ensure all national living donor policies are being upheld.
UNOS schedules 2-day site surveys and provides transplant programs with a list of patient charts they review while on site.
It is possible for a transplant program to have three to four on-site surveys in 1 year.
CMS site survey
CMS focused QAPI survey
UNOS site survey
UNOS living donor survey
III. EVOLUTION OF DATA-DRIVEN QUALITY IN TRANSPLANT PROGRAMSA. Medicare is a federally funded insurance program administered through CMS.
B. If Medicare does not pay for a transplant in a specific transplant program, most private insurers will not pay for the transplant either.
CMS CoP requirements for transplant programs are similar to a private insurer’s requirements for a transplant program to become a center of excellence (CoE).
C. Prior to 2007, there was very little enforcement of transplant outcomes.
Once enforcement began, transplant programs became more focused on data-driven outcomes.
Data were submitted and analyzed but outcomes were not initially tied to payment.
D. Although the initial CoPs required transplant programs to begin implementing quality assessment and performance improvement (QAPI) programs, at first, the surveys did not delve deeply into the QAPI programs.
In August 2013, CMS issued more focused quality standards for transplant programs.5
CMS surveys on Focused QAPI began in 2014.
Because most clinicians and administrations were not formally trained in QAPI processes, initially, there were concerns about the new focus on quality, the SRTR’s analytic methodologies, and potential additional staffing requirements for transplant programs.
At the same time, however, clinicians and administrators began to examine the quality and accuracy of data being collected by their own transplant programs and submitted to UNOS.
Problems associated with data collection/submission and opportunities for improvement were identified, for example:
Lack of staff trained in data collection and submission process
Data entry by busy clinicians who already had a full patient care workload and for whom patient care was their first priority
Failure to submit data in a timely manner
Transplant programs began to take note of the seriousness of failure to meet UNOS and CMS data submission deadlines.
Timeliness of data submission is monitored.
Metrics regarding the timeliness of data submission are reported for each organ-specific transplant program.
Initiatives to improve data collection and submission were implemented.
Programs began to train additional staff whose sole job was to enter data into the secure UNOS portal.
Representatives of the SRTR began presenting at transplant conferences to help clinicians understand the importance of data integrity.
Various agencies offered webinars to help transplant programs understand the importance of integrity of the data entered for analysis.
Today, many data coordinators receive a comprehensive orientation with regard to
Key components of data management
SRTR data submission processes and reports
Risk adjustment profiles
IV. FOCUS ON QUALITY IN TRANSPLANTATIONA. Quality in health care is a complex process and reflects the degree to which health services increase the probability of desired health outcomes and are reliable with current professional knowledge.6
B. The Institute of Medicine has identified six dimensions of quality in health care: health care must be safe, effective, patient centered, timely, efficient, and equitable.7
C. The publication of three reports, “The Urgent Need to Improve Health Care Quality,”8 “To Err Is Human,”5 and “Crossing the Quality Chasm”6 provided evidence regarding quality deficiency in health care and directed clinicians to develop improvements.
Most United States programs have hired a quality manager or quality team, depending on the size of the program.
This new focus on quality has resulted in a better understanding of the need for data accuracy and methods used by the SRTR to determine outcomes.
An example of the emerging global emphasis on quality in transplantation is discussed below.
D. Elements of a QAPI plan
CMS surveyors spend several days focused on the quality aspects of a transplant programs starting with the quality assessment and performance improvement (QAPI) plan.
The QAPI plan serves as a guidance document for a transplant program’s QAPI program.
According to CMS, a quality plan for transplantation includes five elements that must be addressed in a QAPI plan:
Element 1: Design and scope
The design and scope must describe:
How the transplant QAPI plan is integrated with the hospital QAPI plan
A bidirectional flow of communication between the hospital quality department and transplantation
How outcomes are communicated to transplant staff
Activities of all three phases across the continuum of care of transplantation
Activities of all three phases of living donation
Contracted services in terms of reporting their outcomes on a regular basis
The frequency of quality meetings
Members of the steering (or QAPI leadership) committee and each organ committee
The roles of individual(s) responsible for each meeting
How the transplant program addresses adverse events for inpatients and ambulatory care patients
How adverse events are analyzed, including a time frame and staff involved
Roles and responsibilities of transplant personnel in overseeing the quality and safety of patient care across the continuum of pretransplant care, perioperative care, and posttransplant follow-up care
Element 2: Executive responsibilities/governance and leadership
Leadership involvement must be described in the transplant QAPI plan.
This refers to hospital leadership as well as transplant leadership.
It is important for hospital leadership to be aware of the outcomes and quality in a transplant program.
The transplant QAPI plan should be reviewed and approved by the hospital’s governing body. This should be addressed in the QAPI plan.
Resources available to the transplant QAPI should be described to ensure quality and outcomes are effectively covered.
Element 3: Feedback and data systems
This section of the QAPI plan should describe
How data are collected for each measure
Resources available for timely collection of data
How staff is trained and communicates any concerns about processes to leadership
How leadership responds to staff
How communication flows from the program to front line staff
How data are maintained and reported
Element 4: Analyses
The QAPI plan should address
How data are collected and analyzed
Tools used for analyzing data
How data are tracked and used to make meaningful improvements that are sustainable
Element 5: Performance improvement interventions
The plan should describe
How decisions are made to focus performance improvement on high risk, high volume, or problem areas
How performance improvement projects are organized, led, tracked, analyzed, and reported
V. MANAGING DATA WITH SCORECARDSA. Goals of scorecards
The demand to improve patient safety, quality of the processes, and information in transplantation is increasing as it is within all health care organizations.9
In 1998, the IOM made recommendations to improve performance measures through the collection and evaluation of reliable data.10
In transplantation, we have seen an increase in the amount of data that are being collected by health information systems.
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