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DCD

Educational Guide

A Comprehensive Resource for OPOs & Hospital Patient Care Teams for Building and Supporting Effective Practices Surrounding Organ Donation After Circulatory Death

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Essential 11

Continuous Quality Improvement Activities

Strategies to implement a continuous quality improvement (CQI) process through critical assessment, process improvement activities, and quality practices to drive improvement in the hospital’s organ, eye, and tissue donation program

Fact-Finding Questions Hospital Leadership Should Ask

  1. What is our organ donation rate? What percentage of our organ donors are donors after circulatory determination of death (DCD)?
  2. Are all of the policies and procedures mentioned in all of the prior Essentials in place, and do we have a process for measuring compliance in following those policies? Do we have a regular review process for the currency of those policies?
  3. How often are we reviewing data for process improvement opportunities with our OPO coordinator?
  4. How do we align with national benchmarks?
  5. How do we compare to our peers?
  6. To improve our donation outcomes, have we conducted a quality assessment utilizing recognized quality tools such as Plan-Do-Study-Act (PDSA), Root Cause Analysis (RCA) and Failure Mode, Effects, and Criticality Analysis (FMECA)?

Key Points Hospital Leadership Should Remember

  1. Developing a continuous quality improvement (CQI) process for donation practices and pathways within the hospital will ensure safe, efficient, and ethical donation practices.
  2. A robust review of the donation process – from identification of a potential donor until recovery or non-recovery of organs or donation decline, such as with a detailed After Action Review (AAR) – will result in the recognition of areas in the process requiring improvement.
  3. Interweaving the review of donation processes into various meetings as part of the hospital’s key performance areas will ensure a proactive refinement of the donation process and prevent donation from being an after-thought.
  4. Developing a dedicated Donor Council or Donation Committee with multidisciplinary representation (including physicians) and in partnership with the OPO Hospital Development (HD) coordinator provides an ongoing forum for the continued development and refinement of the hospital’s donation program.

Model Elements for DCD Practice Within the Hospital

Implementing a CQI Process

Continuous quality improvement (CQI) in Donation after Circulatory Death (DCD) is essential to ensure the safety, efficacy, and ethical integrity of the process and ultimately leads to better outcomes for both donation and transplantation.  Here are some key aspects of implementing a CQI process in DCD donation:

Figure 11-1: Key Aspects of Implementing a CQI Process.

KEY ASPECTSIMPLEMENTATION
Data Collection and Analysis

Define key performance indicators (KPIs) to assess the effectiveness and efficiency of the DCD process and establish robust systems for collecting and analyzing data related to

  • The DCD processes
  • The DCD outcomes

This data should encompass both quantitative metrics (e.g., donor demographics, organ function) and qualitative feedback (e.g., staff experiences, family satisfaction).

(See the following data section for more details.)

Quality Assurance ProtocolsDevelop and implement standardized protocols for every step of the DCD organ donation process, from donor identification to organ recovery and transplantation. These protocols should align with established best practices and regulatory requirements (see Essential 1).
Staff Training and EducationEnsure that all personnel involved in the DCD process receive comprehensive training on relevant protocols, procedures, and ethical considerations. Continuous education programs should be implemented to keep staff updated on the latest advancements and best practices in organ donation and transplantation.
Risk ManagementIdentify potential risks and complications associated with the DCD process and develop strategies to mitigate them. This may involve regular reviews of adverse events, near misses, and critical incidents, with a focus on learning from these experiences to improve future practices.
Stakeholder EngagementFoster collaboration and communication among all stakeholders involved in the DCD process, including healthcare providers, OPOs, transplant teams, donor families, and regulatory agencies. Encourage feedback and input from stakeholders to identify areas for improvement and innovation. This can be accomplished through AARs.
Ethical ConsiderationsMaintain a strong focus on ethical principles throughout the DCD process, including respect for donor autonomy, beneficence, non-maleficence, and justice. Regular ethical review committee meetings or consultations can help ensure that practices align with ethical standards and societal values.
Continuous Review and AdaptationRegularly review processes and outcomes and be prepared to adapt practices based on emerging evidence, technological advancements, and changes in regulatory requirements or societal expectations.

Strategies for Engagement and Communication for CQI

For CQI to be effective, teamwork, timelines, and proactivity are key. Without implementation of these principles, CQI’s challenges can be difficult to overcome.1

Challenges to Implementing a CQI Process

Prior to being able to identify how best to develop teamwork and timelines, it is important to identify the challenges that can present themselves with a CQI process:1

  • Strategic challenges:
    • Setting inappropriate goals.
    • Inadequate planning.
  • Cultural challenges:
    • Fear of punishment or blame.
    • Resistance or reluctance to quality-focused culture.
  • Technical or structural challenges:
    • Related to the systems, processes, or organizational structure.

Activities to Promote Teamwork, Timelines, and Proactivity

Activities that will promote teamwork between the hospital and the OPO, facilitate the identification of timelines, and promote proactivity include:

  1. Yearly – ideally twice a year – meetings between the OPO HD coordinator, their OPO leadership, and the hospital’s executive leadership to review the hospital’s data and alignment with meeting regulatory requirements as well as their service to the community with regard to effective donation processes.
  2. Regular – ideally monthly – meetings to review data, discuss processes that are working for kudos and reinforcement, identify areas that are not working, and discuss strategies for process improvement. Meetings should include the OPO HD coordinator and the hospital’s middle management involved in the organ donation process (e.g., managers and directors from critical care units [CCUs], the emergency department [ED], the operating room (OR), the respiratory therapy department (RT), and quality department).
  3. If the hospital has a multi-disciplinary Donor Council or Donation Committee that includes the OPO HD coordinator, this group could provide a lot of value in fostering an ongoing quality assessment of the donation processes within the hospital and communication with the OPO. It is important to note that the most effective Donor Councils or Donation Committees involve several physicians from different specialties.
  4. If the hospital does not have a Donor Council or Donation Committee, it can be valuable to incorporate a donation process review by the OPO HD coordinator with and during the hospital’s monthly critical or quality care rounds where other key performance indicators for the critical care areas are reviewed.
  5. Monthly or quarterly participation of the OPO HD coordinator in trauma meetings to review trauma related data and donation processes.
  6. Participation of the OPO HD coordinator in morbidity and mortality rounds in the hospital is encouraged, particularly in cases where donation was a potential or occurred.
  7. Regular participation of the OPO HD coordinator in physician meetings dedicated to improving processes, particularly with physician groups that may see donation cases.

Donation should be interwoven into any hospital meeting where processes occurring in the CCUs, ED, or OR are discussed. This ensures it is considered as a standard practice requiring ongoing quality assessment and process improvement. Additionally, it should be integrated into meetings where end-of-life (EOL) care processes are reviewed. Involvement of an OPO representative, typically the OPO HD coordinator, is important to ensure an experienced donation professional can facilitate the answering of donation-related questions.

Donation Related Data

Typically, the OPO HD coordinator shares donation-specific data with the hospital on a monthly basis. These data reports are commonly referred to as dashboards or scorecards. If the hospital has limited donation activities, these reports may be provided quarterly. It is advisable for hospital leadership to engage in discussions with the OPO HD coordinator to identify any additional data requirements beyond the existing provisions. Both process and outcome metrics can provide helpful insights into the areas of strengths and opportunities. The more granular the data, the greater the chance of pinpointing the specific steps in the process that might need to be improved upon. It is also valuable to utilize the data to give kudos and recognition of excellent processes and actions.

Figure 11-2: Metrics that relate to measuring the DCD donation process.

MEASUREDESCRIPTIONSUGGESTIONS
Timely notificationsTimely notification to the OPO of each potential DCD donorConsider monitoring the impact the timeliness had on

  • Whether the opportunity for donation was maintained clinically,
  • How it relates to whether the family authorized donation

Breakdown the timeliness of calls by department, possibly by service line, by type of patient, etc.

Maintaining the opportunity for donationWas the opportunity for donation preserved by the hospital patient care team?Measuring Donor Management Goals (DMGs) met at time of authorization is an example.
(See Essential 5 for more details about DMGs.)
Donation Conversation & Authorization processHow well was the donation conversation managed with the legal next of kin / legal authorizing party (LNOK/LAP)?
  • Was the process for the donation conversation followed by having the OPO coordinator or the hospital’s designated requestor (if relevant) lead the conversation?
  • Was a huddle conducted between the OPO team and the hospital patient care team to determine how best to collaborate and customize the approach for the donation conversation for each family?
  • Was the appropriate LNOK/LAP presented with the donation opportunity?
  • Was respect and sensitivity demonstrated toward the LNOK/LAP in relation to their cultural and religious needs and practices as per Centers for Medicare & Medicaid Services (CMS) regulations?2,3
  • Was the Uniform Anatomical Gift Act (UAGA)4 followed?
  • Was the designated donor’s decision honored? If not, why not and was that in alignment with the UAGA?
  • If the patient was not identified or no family could be found, was the UAGA followed?
  • If a hospital does not support DCD and does not have a policy, how many families solely declined DCD due to the need to transfer?
  • (See Essential 4 for more details about the donation conversation and see Essential 1 for more details about CMS regulations and the UAGA.)
Organ recovery processHow well did the process work to facilitate all aspects needed for organ recovery? 

  • Monitor OR scheduling processes (e.g., at what time of the day are the cases usually occurring, how much time is added to donation cases due to OR scheduling, how often are donation cases delayed, how many times do families withdraw authorization due to delays in OR times, etc.)
  • Monitor the death declaration process, e.g., were there any challenges in identifying a declaring physician or physician designee? Did the identification cause any delays in the case?
  • Consider any other organ recovery-related processes that could be measured.
Perception of processHow was the process perceived by all involved?
  • Consider measuring family satisfaction with the process?
  • Consider measuring staff (hospital patient care team, OPO recovery team, and transplant recovery team) satisfaction with the process?
Missed DCD opportunitiesHow many DCD potentials were not identified and the OPO was not notified?
  • Consider breaking down the missed opportunities by demographics, diagnosis, unit, service line, etc., to identify potential trends and education and process improvement opportunities.

Figure 11-3: Metrics that relate to measuring the DCD donation outcomes.

MEASUREDESCRIPTIONSUGGESTIONS
DonorsNumber of actual donors
  • Consider trending the number of donors
  • Breakdown details of the donors, e.g., demographics, registered vs. non-registered donors, by units, by service lines, by diagnosis, etc.
DeclinesNumber of declines for donation
  • In addition to the process measures listed in Figure 11-2, track decline reasons.
  • Consider whether the decline reasons were preventable and actionable.
Donation ratesPercentage of potential donors converted to be actual donors
  • Identify the definition of a potential donor utilized in the calculation.
  • If the CMS definition of a potential donor** is utilized, consider comparing the donation rate to what it would have been had it been based only on ventilated potential donors.
  • Review the donation rate trends over a period of time.
  • Identify how the hospital is benchmarking in comparison to peer hospitals of similar make-up.
Authorized Not Recovered (ANR)Patients who did not become donors despite authorization for donation.
  • If donation did not proceed despite authorization for donation, monitor the reasons and their frequencies. What could have been prevented?
Organ utilizationThe number of organs utilized for transplantation
  • Review the organs recovered for transplant versus those that were actually transplanted.
  • Compare the number of organs transplanted in relation to the number of organs that could have been transplanted.
  • Identify reasons for non-utilization of organs, was it something that is preventable?

**CMS definition of a potential donor: Inpatient deaths among patients 75 years old or younger with a primary cause of death that is consistent with organ donation (based on death certificates).5

Sites for additional data mining can be found in the resource section below.

  1. Endalamaw A, Khatri RB, Mengistu TS, et al. A scoping review of continuous quality improvement in healthcare system: conceptualization, models and tools, barriers and facilitators, and impact. BMC Health Serv Res. 2024;24(1):487. doi:10.1186/s12913-024-10828-0
  2. The Federal Register. § 482.45 Condition of participation: Organ, tissue, and eye procurement. Accessed May 13, 2024. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-C/section-482.45
  3. The Federal Register. § 485.643 Condition of participation: Organ, tissue, and eye procurement. Accessed May 13, 2024. https://www.ecfr.gov/current/title-42/section-485.643
  4. Organ Donation and Transplantation Alliance. State legislation & donor registries by state. Accessed May 13, 2024. https://www.organdonationalliance.org/resources/state-uaga-legislation-organ-registry-info/
  5. Centers for Medicare & Medicaid Services. Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs (CMS-3380-F). Published November 20, 2020. Accessed May 13, 2024. https://www.cms.gov/newsroom/fact-sheets/organprocurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos