The historical monitoring of just survival outcomes to monitor program quality is outdated and insufficient. The Catapult Consultants report provided specific instructions for ensuring that transplant programs also analyze process measures. They further describe the need to implement quality measurement at all phases of transplantation including the pretransplantation phase (during evaluation and while waitlisted), the inpatient and perioperative phase, and the posttransplantation phase. Their guidelines necessitate a minimum of nine quality measures per organ program with at least three measures per phase of transplant, at least one of which is an outcome measure and at least one of which is a process measure. This guideline, although tremendously helpful for both transplant centers and surveyors in setting forth clear expectations, is not exhaustive of all necessary quality assessment practices for Transplant Centers, nor does it provide practical guidance to transplant programs for building their quality plan in a collaborative and meaningful way. For example, their guidelines cover process and outcome requirements but do not encompass structure monitoring or value monitoring.

Avedis Donabedian’s work on the structure, process, and outcome (SPO) paradigm has been frequently cited as the necessary comprehensive framework for quality measurement in healthcare (Donabedian 1988). Specific structural parameters have long been required in order for a transplant program to obtain and maintain institutional membership in the OPTN. In addition, the majority of the CMS Conditions for Coverage can be categorized as either structure, process, or outcome requirements. Given that both the OPTN rules and CMS rules are required (OPTN for membership and CMS for reimbursement), it is a worthwhile safeguard to include measurement of these rules as part of a comprehensive QAPI program. Donabedian (1988, 2005) describes structure variables/measures as the setting in which care is delivered including adequate facilities and equipment and qualifications of personnel. This data is often readily accessible and objective making it an easy opportunity for data gathering. For example, it should be relatively easy for a transplant program to gather and monitor data on maintenance of competencies for personnel (a CMS requirement), monitor appropriate personnel on nursing units (a CMS requirement), and monitor appropriate vessel storage units (an OPTN requirement).

Value in healthcare is defined as outcomes relative to costs (Porter and Teisberg 2010). Value has been recognized as the one goal that is overarching for all stakeholders involved in transplantation: hospitals and healthcare providers, regulators, payers, and patients (Porter and Teisberg 2010). As organ transplantation costs are very closely monitored within the hospital setting due to Medicare cost report requirements, obtaining this data should be practical and accessible for transplant programs. Monitoring costs as the denominator in the value equation can assist a program in ensuring that care is delivered efficiently and responsibly. In organ transplantation, process measures are very telling indicators of efficiency, and utilizing a process measure relative to cost will also be an effective tool for measuring value in this setting. For example, if the liver transplant program utilizes a fast-track option for high-MELD patients, it may be an area they wish to analyze to explore cost savings with this option. Therefore, looking at the average cost for fast-track evaluations is a useful value measure. As an additional example, graft survival at 1 month is a common outcome measure. To look at this in terms of value, a simplified measure would be 1-month graft survival relative to a cost measure such as posttransplant costs at 1 month. Having an understanding of costs at different phases of transplant and relative to different processes and outcomes from within the program is very useful in understanding how the program provides high value to the patients.

In summary, utilizing the Donabedian SPO paradigm plus the addition of V (value) as a more modern construct, a best practice for a transplant program is to have SPOV quality assessment measures at all phases. Please refer to Table 1 as an example of quality measures to meet minimum regulatory guidelines for QAPI (at least three measures per organ per phase with at least one process and one outcome) while also capturing structural indicators and value-related indicators.

Although the examples illustrated in Table 1 may be useful for a program, it is important for transplant programs to have a quality committee or council tasked with collaborative agreement on quality measures. The CMS guidelines recommend establishing a quality committee whose membership is clearly defined in terms of disciplines, roles, and format and frequency of meetings. Table 2 lists the recommended functions of a quality committee (Norris 2008). CMS requires that key personnel be included on the quality committee. Key personnel are defined as medical and surgical directors and all key members of the multidisciplinary team such as transplant coordinators, etc.

The quality plan developed by the quality committee should be updated annually to ensure that it is effective. It should be considered a program “policy” and adhered to as such. CMS defines in its Interpretive Guidelines what the quality plan should include. In addition to defining the team members by title and role, the quality plan should include explanation of decision-making methodology such as committee vote, subcommittee vote, etc. The plan should list the measures you choose, list the benchmarks and goals chosen, and list the methodology by which data will be analyzed to obtain each measure. For example, the quality plan associated with the example measures above in Table 1 would list the measures and the numerator and denominator for each one established. Average time from referral to waitlist, for example, should include information in the plan as to what date is considered the referral date and where the referral date is being obtained. The purpose of this is to ensure that measures are truly objective data driven and are not estimates or subject to collection bias.

The quality plan should also list the frequency with which the quality committee will meet and how often new measures will be established. Reporting methodology from the quality committee to the hospital-wide QAPI program or quality committee is important to be defined in the plan as well. Specifically the plan should include what is being reported, how often it is being reported, and to whom. The program should be prepared to have available documentation to demonstrate that this is happening. Any recommendations from the hospital-wide QAPI committee should be documented.

CMS requires that a person be designated to be responsible for monitoring the quality plan and this person should be listed within the plan document. Commonly this position is considered a quality coordinator or a QAPI coordinator. This person also does not need to be the same as the QAPI chairperson. The chairperson’s role can be a clinical lead or a decision maker. The trend nationally, as demonstrated by the UNOS staffing survey of 2015, is for this position to be embedded within the transplant program and for at least one full time equivalent be dedicated to the program in this capacity. The QAPI coordinator should ensure that data required for analysis is readily available, valid, and comprehensive. The QAPI coordinator should coordinate quality committee meetings, maintain the quality plan, represent the program for hospital-level quality meetings, and work toward bringing consensus to the team on matters of quality decision making. The QAPI coordinator should have readily available all documents related to the quality plan for immediate dissemination in the event of an on-site visit from CMS. These documents, although accessible to the transplant team, should be kept in a secure location due to the sensitivity and peer-protected nature of the information.

Also required within the quality plan is evidence of tracking and implementing recommendations for improvements, evidence of ongoing compliance with changes as recommended by the committee, and broad representation of transplant program issues across disciplines. In order for the quality committee to achieve all that is laid out in the plan, plus meet the SPOV framework, choosing measures is the next step.

Additional quality plan items include the program’s adverse event policy and policy for tracking of complaints and incidents. A recommended table of contents for the quality plan can be found in Table 3.