In our previous blogs, we have reviewed some aspects of transplant operations, how to stay compliant and how to address concerns raised by regulatory agencies such as the United Network for Organ Sharing (UNOS) and the Centers for Medicare and Medicaid Services (CMS) when issues arise. Our next series of blogs will focus on how transplant programs can proactively track their progress and address potential problems before theybecome major issues. During this series, we will review the structure, operations and tools of an effective Quality Assessment and Process Improvement Program (QAPI). First, let’s review the 5 aspects that create the conceptual framework for a QAPI program under the Medicare requirements.
The first aspect, Design and Scope, provides guidance of what a QAPI program is; namely, a data driven, ongoing and comprehensive multi-disciplinary quality effort that covers all phases of transplantation and donation including patient safety, clinical care, quality of care and those services provided under contract or arrangement. The transplant QAPI program, which is written and integrated with the hospital quality program, includes processes to identify high risk, high/low volume and problem prone areas and methods for conducting analyses, implementing corrective actions, evaluating improvements and assessing whether these improvements are sustained. These programs must include multi-disciplinary participation, methodologies to fulfill hospital and federal requirements and assessments for both process and outcome objective measures. The QAPI program must establish the frequencies for performance review, methods to identify transplant specific adverse events and the structure of investigation processes. Finally, the methods of bi-directional communication between transplant and hospital programs must be clearly delineated.
The second aspect of a QAPI program focuses on Governance and Leadership. The hospital leadership team and governing body must clearly be engaged in QAPI oversight by setting the expectations for quality and safety as well as by ensuring that the QAPI program is adequately resourced and implemented and ongoing in a comprehensive effective manner. The transplant program must identify the members of the multi-disciplinary QAPI team and be assured that they are appropriately educated and trained to set the expectations for safety, quality care and patient rights utilizing input from transplant program staff, transplant recipients, living donors and their families or representatives. The transplant QAPI reports are provided to hospital leadership and the appropriate hospital QAPI and governing bodies that provide assessment as well as guidance back to the transplant program to improve and sustain quality of care and program performance reducing the risk of future harm.
As QAPI programs are data driven, the third focus of the program is on feedback, data systems and monitoring. Transplant programs must have systems in place to monitor care and services in all phases of transplantation as well as living donation with both process and outcome indicators. The feedback systems must include input from staff as well as transplant patients, living donors and their families or representatives and must include a bidirectional communication of these assessments and recommendations between hospital and transplant QAPI programs. The process and outcome indicators chosen must reflect the complexity of the services the transplant program provides and define, measure, analyze and track the information compared to established applicable benchmarks or targets in order to respond to adverse events and prevent recurrence.
Systematic analysis and systemic action represents the fourth aspect of the QAPI program and reflects the methodical approach that is employed to determine when an in-depth analysis to understand improvement opportunities, causes and implications of change for care and services delivered is needed. The program must have policies and procedures that address the performance of and provide evidence of proficiency in thorough analyses. The program must analyze data that is collected relative to proactively defined quality indicators and use systemic methods to analyze adverse events. Adverse events as defined in the CMS regulations means an untoward, undesired and usually unanticipated event that causes death or serious injury or the risk thereof. Thus, it is important to recognize that near-misses can be considered adverse events. CMS further describes transplant specific adverse events as including but not being limited to graft failure, serious medical complications or death in a transplant recipient or donor, unintentional transplantation of organs of mismatched blood types, transplantation of organs to unintended beneficiaries and unintended transmission of infectious disease to a beneficiary. The transplant program employs a structured approach with policies and procedures to comprehensively assess with a root cause analysis all involved systems to avoid future negative events and occurrences.
The final aspect of a QAPI program is a focus on performance improvement through which the transplant program defines, implements and evaluates interventions made to improve care. These efforts involve gathering of information to identify issues, the introduction of interventions and then reassessment once the interventions have been implemented. The documentation of these performance improvement interventions should reflect the utilization of the program’s defined performance improvement methodology and should reflect bi-directional communication of the findings, interventions and outcomes between the transplant program, staff, and hospital leaders.
About the Author: Dr. John Daller, MD, PhD, FACS
As a former Director of several transplant programs, Dr. Daller has expertise in all aspects of transplant program management, as well as hospital program development including clinical, regulatory, business and administrative leadership via his company Strategic Illuminations. He consults in the area of medical legal review, due diligence and scientific evaluations, as well as utilization review via Daller Consulting. He is also Chief Medical Officer of Concordia Valsource, LLC which provides consultative services to developing biopharmaceutical companies and to Venture Capital groups investing in the health and life sciences. Previously, Dr. Daller was Vice President for Medical Programs in the Transplant Business Unit of Genzyme Corporation.