The Alliance

Insight Series

The Alliance insight series offers critical resources for stakeholders across the donation and transplantation continuum. For each topic, you can find related action items, tools, and references.

The Alliance Insight Series

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A Note About Content

Some legacy resources on this website may refer to UNOS in place of the OPTN, reflecting common usage at the time of publication when the two were often used interchangeably. In recent years, significant work has gone into distinguishing these as separate entities: the OPTN is the nationwide organ transplant network established by federal law, while UNOS is one of several organizations currently under contract to support OPTN operations. We’ve preserved these resources as originally published, but recommend referring to current terminology for the most accurate understanding of each organization’s role.

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APRIL 2025

Apr2025 TQC

From its inception in 1986 through continuous refinement in 2024, CMS’s oversight of transplant programs is the federal government’s earnest attempt at ensuring high standards of care. While CMS oversight has undoubtedly improved transplant program accountability and patient safety, many transplant centers still struggle with the balance between regulatory compliance and real-world clinical decision-making.

The 2024 updates reflect progress, but transplant leaders continue to advocate for a more streamlined, patient-centered approach that reduces administrative burdens while maintaining high standards of care. The Conditions of Participation (CoPs) and SOM Appendix X serve as an essential tool for transplant programs to be successful in meeting these standards.

1986

LAYING THE REGULATORY FOUNDATION: Early Oversight of Transplant Programs

The Federal Government Steps In

  • Following growing concerns over program variability, inconsistent patient outcomes, there was a call for national oversight in the rapidly advancing field of transplantation.
  • The Omnibus Budget Reconciliation Act (OBRA) of 1986 mandated that organ transplant programs receiving Medicare and Medicaid funding meet federal quality, safety, and performance standards.
  • The Health Care Financing Administration (HCFA, now CMS) was tasked with developing regulatory standards.
  • Surveys were conducted by State Survey Agencies under CMS oversight.
  • Programs previously varied greatly in eligibility criteria, outcomes, and quality standards.

Impact on Transplant Programs:

  • Established a basic regulatory structure and national benchmarks.
  • Lack of implementation detail created compliance uncertainty.
  • New reporting burdens without standardized metrics.

2007

ESTABLISHING COMPREHENSIVE NATIONAL STANDARDS

CMS Codifies Conditions of Participation (CoPs)

  • Regulation introduced to address inconsistent enforcement and disparate outcomes.
  • Formalized eligibility, performance measurement, patient safety protocols, and quality improvement requirements.

Key Tenets:

  1. CMS Certification required for Medicare and Medicaid reimbursement.
  2. Defined the conditions of transplant program CoPs.
  3. Programs must track data and implement corrective actions as needed.

Impact on Transplant Programs:

  • Created structure and national oversight consistency.
  • Programs risk losing certification due to poor results.
  • Significant new administrative burden.

2008

ENHANCING SURVEY AND COMPLIANCE PROCESSES

  • Appendix X added to the State Operations Manual (SOM) to provide “how to” guidance.
  • Interpretive guidelines help ensure consistent evaluations.
  • Processes defined for scoring compliance with CoPs.

Impact:

  • More consistent surveys, less subjectivity.
  • Labor-intensive site visits place demands on staff.

2010–2015

INCREASED SCRUTINY & LIVING DONOR PROTECTIONS

  • Focus shifted to prevention rather than punishment.
  • CMS initiated targeted surveys and piloted third-party surveyor contracts.
  • Living donor protections strengthened.
  • QAPI refinements introduced.

Impact:

  • Enhanced living donor safety, fewer liability risks.
  • Increased administrative burden balancing multiple oversight bodies (CMS, OPTN, IRB).

2017

RESHAPING MODERN OVERSIGHT & FLEXIBILITY IN REGULATIONS

  • Revised SOM Appendix X aligned CMS and OPTN guidance.
  • Standardized surveyor processes to reduce variability.
  • More flexibility in corrective actions.

Impact:

  • Improved data clarity and reduced ambiguity.
  • Surveyors and programs had clearer expectations.

2019–2021

ALIGNING FOR GREATER FLEXIBILITY IN QUALITY STANDARDS

  • CMS signaled flexibility in how programs meet requirements.
  • Encouraged programs to use their own data to identify quality gaps.
  • Stronger emphasis on QAPI and multidisciplinary team decision-making.

Impact:

  • Programs with complex cases felt less penalized.
  • State agencies took on more survey responsibility.

December 2024

THE LATEST UPDATES & THE FUTURE OF CMS OVERSIGHT

  • CMS updates to Appendix X reflect input from audits, patient safety, and transplant teams.
  • Standardized surveyor training and streamlined processes.
  • Real-time data reporting and deeper analysis.
  • Focus on multidisciplinary collaboration and QAPI accountability.

Impact:

  • Improved transparency and clarity.
  • Patient safety enhancements for living and high-risk donors.
  • Continued burden of administrative documentation remains a challenge.
CMS Readiness Checklist 2025

Survey Reports
(Required within 4 hours of arrival)

Existing Elements:

ADDED Elements

  Active waiting list
  •   Name
  •   Date of Listing
  •   Wait List Status
  •   MRN
  •   Age
  •   Race
  •   Gender
  Total number of individuals on the waiting list
  Waitlist Removals (non-death) past 12 months
  •   MRN
  Waitlist Removals due to death or transplant (New Report)
  •   Name
  •   MRN
  Evaluation Declines past 12 months
  •   Name
  •   MRN
  •   Decision Date
  •   Decision Reason
  Transplanted last 18 months
  •   Name
  •   DOT
  •   MRN
  •   Age
  •   Race
  •   Gender
  •   Address
  •   Country of primary residence
  •   Date of Death / Graft Failure
  Living Donors evaluated past 12 months
  •   Name
  •   MRN
  •   Organ donated
  •   Date of donation
  Currently admitted transplant and living donor patients
  •   Unit
  •   Floor
  Follow-up visits for post-transplant & post-donation (New Report)
  Declined Organ Offers past 18 months (New Report)  List and number of declined offers with decline code

Survey Reports
(Required within 4 hours of arrival)

What are surveyors looking for?

  Schedule for all multidisciplinary team meetings *including rounding

  •   Attendance and roles of the team members
  •   Leadership and collaboration within the team
  •   Communication among team members
  •   Involvement of recipient/family in care decisions
  •   Documentation and evidence of individualized implementation and evaluation of patient’s plan of care to ensure they are meeting their goals

  Schedule of Selection Committee meetings

  •   Attendance and leadership of the meeting
  •   Team participation in patient discussion
  •   Selection criteria used
  •   Process for making determinations
  •   Outcome of meetings
  •   Results shared with patient/family
  •   Review of prior minutes for consistency

  Schedule of all QAPI meetings

  •   Team member attendance
  •   QAPI leadership identification
  •   Issues and concerns identified
  •   Improvement plans and follow-up
  •   Action items and results documented

Additional opening survey required documentatioN

  Organizational chart

  Incorporates how the transplant center fits into overall hospital organization

  Schedule of Selection Committee meetings  Incorporates how the transplant center fits into overall hospital organization
  Contracts

  Incorporates transplant center into hospital organization. Include, but not limited to:

  •   HLA services
  •   Living donor – NKR, APD
  Training schedule for personnel (New Documentation)
  •   Agenda
  •   Dates
  •   Evidence of attendance
  On-call schedule for transplant surgeons and physicians (past 30 days)

  Quality related documentation

  Adverse Events for the past 24 months (New extended time frame)

  Adverse Event/ Occurrence Policy

  Quality Assessment and Performance Improvement (QAPI) Plan

  Hospital QAPI Plan

  QAPI reports, records, minutes

POLICIES

New / Emphasized requirements:

  Patient Selection Criteria for transplant and living  donors

  ABO Verification Policy Transplant Recipients & Living Donors

  Include associated blank forms

  Waiting list management policy

  Including patient notification

  Psychosocial Evaluation Policy for transplant candidates and living donors (new policy requirement)

  Update policies to include the following:

  •   The length of time in which the psychosocial evaluation is deemed to be current and/or frequency of re-evaluation to determine continued appropriateness;
  •   The type of qualified professional healthcare personnel (MSW, LCSW, psychiatrist or psychologist) who may complete these evaluations;
  •   The follow-up and referral procedures if a transplant candidate requires such activities; and

  The method of communicating the psychosocial evaluation findings into the selection process.

  Patient Management Policies for transplant and Discharge

  •   Transplant programs should define the structure of their evaluation and transplant processes
  •   Patient management policies for the discharge phase of transplant should have mechanisms in place to identify, assess, and meet the medical and psychosocial needs of the patient to ensure they have the resources necessary to care for their transplant.
  •   These patients will require discharge planning at an early stage of their hospitalization to ensure their discharge needs are identified and addressed prior to actual discharge.

  Living Donor Management for Pre-donation, donation and discharge phases

  •   Transplant programs that provide living donor transplant services must develop and implement living donor policies that direct the care and management of donors through their evaluation, donation, and discharge after donation.
  •   The evaluation policies must ensure it incorporates at a minimum, all potential donors that have chosen to undergo all or any portion of the transplant program’s evaluation process.
  •   Transplant programs should ensure its discharge policies for living donors are based on the hospital policies for discharge planning.
  Informed Consent policy for transplant recipients and living donors

  Policy needs to be updated to include the following:

  •   Who is responsible for discussing the informed consent process with the potential donor;
  •   Where the discussions concerning the informed consent process are documented in the medical record;
  •   The methods used by the program to ensure and document the potential donor’s understanding of the information being delivered; and
  •   When the discussion(s) will take place, if the information is provided at different points of the donation process.
  Communication between patients and dialysis centers
  Availability of transplant team
  •   The transplant program’s policies must address communication methods to inform patients of situations or events that could impact their ability to receive a transplant.
  •   If the event is related to an emergency situation, which may or may not require transfer of patients to another hospital, the transplant program is expected to notify patients on the waiting list of the emergency plan in accordance with the program’s emergency preparedness protocol in place.
  Potential unavailability at centers with single surgeon/physician
  Emergency Management Preparedness

  Patient Education: all material used pre and post-transplant and pre and post living donation

  •   Include education that explains selection criteria.

Additional Regulations for Consideration

  A request for nutritional and/or social services can also be made by the patient, family member(s)/caretakers, and/or the patient’s multidisciplinary team.

Living Donor Services Under contract arrangement

  Have written evidence of a contract or agreement with the living donor transplant program(s). This may be a specific contract or agreement between two hospitals or programs, or it may include participation in a transplant registry for paired donation of living donors and recipients.

  Have a copy of the Medicare-approval letter for the living donor transplant program with which it has a contract or agreement, or have documented evidence that the CMS website listed below was reviewed prior to accepting the living donor organ to ensure that the program was a Medicare-approved program.

  Donor record information requirements:

  •   There is a complete medical and psychosocial evaluation in the medical record completed by the relevant professionals of a multidisciplinary team which has determined that the individual is a suitable living donor.
  •   An Independent Living Donor Advocate (ILDA) has met and worked with the potential living donor and has been included in the discussions of the potential donor’s suitability.
  •   There is a fully documented informed consent process in the living donor’s medical record that meets the minimum Medicare requirements.

  As part of the Quality Assessment and Performance Improvement (QAPI) requirement, ensure that there is a feedback system between the recipient and donor hospital to address any adverse events that occur in the donor or the recipient for a specific donation or transplant.

A SPECIAL THANKS TO THE TRANSPLANT QUALITY CORNER WORKGROUP

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Ashley Cardenas
MAS, MBA, FASTTransplant AdministratorRenown Transplant Institute
AlisonPeck
Allison Peck
MSN, CCTC RN-BCClinical Transplant Program Coordinator Kidney & Pancreas TransplantCedars Siani Medical Center
Abbey Olsen
Abbey Olsen
MSN, RN, CCRNTransplant Quality ManagerUniversity of Utah Hospital
Adriana Kochi
Adriana Kochi
MHA, CPHQTransplant Quality DirectorInova Fairfax Hospital
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Melissa Robinson
Quality & Safety Director, Transplant Institute Loma Linda University Medical Center
Lawson Jenna Silo 1
Jenna Lawson
MSProgram Director, Pediatric TransplantVanderbilt University Medical Center
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Lecia Snell Kinen
MSN, RN, CCTCManager, Quality and ComplianceKeck Medical Center at USC
Ff 4ab2fbf66829b830ecca7eee90f146cb Ff Smith Lindsay
Lindsay Smith
RN, MSNTransplant Quality DirectorVanderbilt University Medical Center

FEEDBACK

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