DCD

Considerations for the withdrawal of life-sustaining treatment (WLST), declaration of circulatory death, organ recovery, and advanced organ procurement technologies

Fact-Finding Questions Hospital Leadership Should Ask

1. What is our process for WLST and comfort care for the potential Donation after Circulatory Death (DCD) donor?
2. What is our comfort care medication administration protocol for all critical care patients facing end-of-life (EOL) care?
3. Does our DCD policy contain a detailed plan for where and how WLST occurs in DCD cases?
4. How do we determine who the declaring physician or physician designee will be? Do we have any limitations with declaring physician/designee availability? How often do restrictions on physician availability for pronouncement impact DCD cases?
5. What is our circulatory (cardiac) death declaration policy?
6. How does our Operating Room (OR) prioritize organ donation recoveries?
7. Do our ICU and OR teams understand their role and responsibilities for WLST and organ recoveries?
8. What practices do we have in place to honor the donor decision (e.g., Honor Walks, Moment of Silence)?
9. Does our policy allow for the donor family to be in the OR during WLST and comfort care?
10. What questions do our ICU and OR teams have about DCD organ recoveries?
11. What is our process if a patient does not die in the time frame necessary to donate organs?

Key Points Hospital Leadership Should Remember

1. The declaring physician or physician designee cannot be part of the OPO or transplant recovery team.
2. The declaring physician or physician designee must remain at the bedside for the duration of WLST to provide ongoing appropriate comfort care, and to determine time of death as soon as it occurs.
3. The hospital must have a DCD policy that addresses the use of a validated test to determine circulatory cessation. It should also include a required ‘observation period’ or ‘hands-off period’ (typically 5 minutes according to OPTN and ethical recommendations¹) to monitor for and verify an absence of autoresuscitation. The verification time frame should be identified in the policy.
4. Family needs, including presence at the end of life and during WLST in the OR, should be honored and addressed in policy.
5. The OPO and transplant recovery teams may not participate in, nor give advice regarding WLST, comfort care, or declaration of death.
6. The transplant recovery team must exit the room prior to WLST and may not reenter the room until death is declared.
7. The acceptable time frame for organ viability from WLST to death declaration is dependent on several factors and should be determined by the OPO and/or transplant recovery team on a case-by-case basis.

Model Elements for DCD Practice Within the Hospital

Preparation for WLST and Organ Recovery

The OR should be notified of the potential DCD as soon as authorization is obtained. Together, the OPO recovery team and OR team will collaborate on the timing of the recovery with input from the transplant recovery teams and declaring physician or physician designee. In addition, any family requests for timing should be honored, if possible. Another consideration for the hospital is identifying the priority status for the organ recovery to ensure that the timing is not bumped for cases other than possible emergencies. “Bumping” organ recovery times can negatively impact the family who is emotionally prepared for the set OR time,  the transplant recovery teams already in transport to the hospital, the declaring physician or physician designee who committed their availability to pronounce the death of the patient, as well as the intended donation recipient who is simultaneously being prepared for their transplant surgery.

The hospital should establish a protocol to hold either the ICU bed or an alternate non-critical care bed in the event the patient does not die within the time frame necessary to preserve organ viability for transplant. If organ recovery must be aborted, the patient should then be transported to the pre-identified bed for continued comfort care.

Withdrawal of Life-Sustaining Treatment (WLST)

The WLST process for a potential DCD donor should closely follow the same WLST process as for any other hospital patient. This includes the administration of comfort care medications.¹ The hospital should identify a location for WLST in their policy. The preferred location for WLST is the OR room to allow for prepping and draping, however an adjacent OR room, the Post Anesthesia Care Unit (PACU), and/or the ICU room may be more appropriate dependent on the specific situation. If WLST occurs in a location other than the OR room where the organ recovery will occur, careful consideration must be given to its proximity to the OR room. Any transportation time between locations must occur during the hands-off period (typically 5 minutes). Any delay in the first incision being made after the hands-off period adds to the warm ischemic time (WIT), which in turn places a risk on organ viability. The patient will not be transported to the location of WLST (if other than the ICU), and WLST will not begin until it is confirmed that the transplant recovery teams have arrived at the hospital. During transport to the location of WLST, the potential DCD donor should be monitored and mechanically ventilated.

When WLST occurs in the OR, the potential donor is transferred to the surgical table. The OR room should already be set up for the recovery, with all required tables and instrumentations in place. The OR team may complete the surgical scrub and apply sterile drapes prior to WLST. Completing these steps prior to WLST reduces WIT of the organs. The transplant recovery team is allowed to verify the set-up of the room prior to WLST.

A surgical time-out confirming the correct patient and procedure should be performed with the OR team, the ICU nurse, declaring physician or physician designee, OPO recovery team, and transplant recovery team prior to WLST. Once the surgical time-out is completed, the transplant recovery team must leave the OR before the WLST process begins.^1,2

As with any EOL situation, The Institute of Medicine (IOM), now the National Academy of Medicine, in its 2000 Practice and Protocols, recommended following the patient’s and family’s wishes as closely as possible, which includes allowing the family to be present at the time of WLST.³ If WLST occurs in the OR, this can be accomplished by designating an OPO family support person to escort the family to and from the OR, adequately preparing them for what they may experience, and ensuring that they wear appropriate attire within clean areas of the OR. Additional considerations in the OR include dimming the lights, warming the room, and draping the patient and surgical tables in such a manner as to shield the surgical set-up from the view of the family and to create as warm and comforting environment as possible. The family should be brought into the room and seated around the patient’s head after the transplant recovery team exits the room. The OPO family care coordinator will prepare the family to say their final goodbyes and exit the OR upon declaration of death. Whether the family is present for extubation or is brought into the room after terminal extubation is dependent on the hospital and family decisions.

Prior to WLST, a dose of 30,000 units of intravenous Heparin is typically administered^1,3 to prevent microemboli/thrombi formation in the organs. Comfort care medications to alleviate pain and discomfort should be given to the potential DCD donor, as for any patient going through EOL care and will be directed by the declaring physician.¹ A consideration that should be addressed by the hospital is how the comfort care medications will be released to the ICU nurse for administration, especially if WLST does not occur in the ICU. Once terminal extubation has occurred, the ICU nurse and declaring physician or physician designee remain with the patient and follow hospital policy for WLST until death occurs.

The OPO and transplant recovery teams may not participate in WLST or make any recommendations toward comfort care medication administration. During WLST, at least one OPO coordinator will usually remain in the room to document vital signs as required by the OPTN contractor and transplant programs.

The ICU nurse, declaring physician or physician designee, and respiratory therapist have important responsibilities during transportation of the potential donor to the location of WLST and during WLST:

• ICU Nurse: Assists potential donor to location of WLST, administers comfort care medications during WLST, documents interventions per hospital policy.
• Declaring physician or physician designee: Present for WLST, directs comfort care medication administration, identifies start time of cessation of circulation, monitors for autoresuscitation during “hands-off” time, declares time of circulatory death, documents the death note in the electronic health record (EHR).
• Respiratory Therapist: Assists potential donor to location of WLST (with portable ventilator if requested by OPO) and upon physician order, extubates potential donor at time of WLST.

Declaration of Circulatory Death

Death determination for DCD donors is based on the permanent cessation of circulation⁴ and is completed according to state law and hospital policy. Death must be determined promptly to limit WIT and preserve organ viability;⁴ therefore, the declaring physician or their designee should be present throughout the dying process. In order to declare death, the declaring physician or their designee must verify that circulatory cessation has occurred and that the period for possible autoresuscitation has elapsed. (This is also known as the “observation period” or “hands-off period.”)

­­Requisites to determine death after WLST in DCD protocol⁵

1. Verify that circulatory cessation has occurred using validated test:
   • Absence of arterial pulsations observed by an indwelling arterial line or absence of continuous flow generated by a ventricular assist device or extracorporeal circuit;
   • Absence of opening of the aortic valve by echocardiography;
   • Absence of circulation by arterial Doppler studies; or
   • Absence of electrical activity on an electrocardiogram;
     Preference should be given to non-pulsatile arterial line monitoring^4,5
2. Verify that the time for possible autoresuscitation has elapsed
   • In a 2021 international prospective study, 4 minutes 20 seconds was the “longest duration of pulselessness before resumption of cardiac electrical and pulsatile activity.” ⁶
   • While practices have previously varied between 2 minutes³ and 5 minutes,^5,6 with the expanding use of NRP (normothermic regional perfusion), most organizations have transitioned to a 5-minute waiting period. This has now also become an OPTN recommendation.

Once the declaring physician or physician designee (independent of the OPO and transplant recovery teams) verifies that circulatory cessation has occurred and that the minimal observation period has elapsed, death may be declared based on the permanent absence of circulation.⁵ The family should be notified and (if present) allowed to say final goodbyes, and escorted from the OR or the location of WLST. The transplant recovery team may then enter the room and organ recovery can begin.⁷ The declaring physician or their designee must write the death note immediately upon death declaration and make it available to the OPO recovery team.

In the event that, during comfort care, it is determined that the time for organ viability for transplant has passed, as determined by the OPO and transplant recovery teams, the patient is moved to the predetermined location (return to ICU room or another room) and comfort measures will continue to be provided by the hospital patient care team. The patient may still be a potential tissue and eye donor once death has occurred.

Checklist for WLST and Declaration of Circulatory Death

The following checklist outlines considerations for the hospital to include in policy and procedure. Note that items in bold are ethical and/or federal policy requirements that must be adhered to.

• Clearly defined roles and responsibilities of hospital patient care team members involved in WLST and organ recovery
• Location for WLST (e.g., OR, PACU, ICU) and process for transportation during the “observation period” or “hands-off period” to the OR, if WLST does not occur in the OR
• Identification of physician or physician designee (e.g., mid-level provider or registered nurse if allowed by state law and hospital policy) responsible for death determination
• Statement that the declaring physician or physician designee cannot be part of the OPO or transplant recovery team^1,2
• Clarification that the declaring physician or physician designee must remain at the bedside for the duration of WLST to provide ongoing appropriate comfort care as well as to determine the time of death
• Transplant recovery team is on-site prior to WLST and may verify room set-up
• A surgical time-out is performed prior to WLST
• Transplant recovery team must exit the OR prior to WLST and may not reenter until after the death declaration^1,2
• Considerations for family presence for WLST in the OR, with a member of the OPO team assigned to support the family
• OR room set up (e.g., draping, dimming of lights, temperature of the room)
• Comfort care medication administration per hospital policy, with the stipulation that the OPO and transplant recovery teams may not participate in or make recommendations for WLST and comfort care medication administration
• 30,000 units Heparin administration as per organ recovery protocol (unless otherwise requested)
• Process for releasing comfort care medication to ICU nurse if comfort care is performed in the OR
• Identify how circulatory cessation will be determined (what validated test and electrical rhythm, if monitored)
• Time frame for determining that autoresuscitation has elapsed (also referred to as “observation period” or “hands-off period”)
• The acceptable wait time (time from extubation to death declaration) for organ recovery is determined by the OPO and/or transplant recovery teams
• Location (e.g., ICU room or other predetermined room) for continued comfort care, should death not occur in a time frame that maintains organ viability for transplantDOWNLOAD PRINT FORMAT

The OR Process

The DCD process in the OR is hospital-specific. Each hospital in collaboration with their OPO should work through the anticipated needs to establish guidelines tailored to their facility and (when necessary) to each specific patient care area for DCD recovery. These guidelines will require dynamic updates, as practices in DCD recovery continue to evolve in the United States.

The OR room is typically set up with all of the anticipated equipment and instrumentation prior to WLST. Generally, there is a transplant recovery team assigned to each organ type procured. Often kidneys are recovered by the same transplant recovery team procuring the liver or a transplant recovery surgeon/OPO recovery surgeon local to the area. The transplant recovery team (consisting of surgeons and organ preservation technicians) are assisted by the OPO recovery team and the hospital OR team assigned to the case. At minimum, the hospital is responsible for providing a scrub nurse or technician and a circulating nurse. If the lungs are to be recovered for transplant, after the death of the patient and after the main aorta has been cross-clamped, an anesthesiologist may be required to assist with re-intubation and re-inflation of the lungs to facilitate lung recovery.

The transplant recovery team arrives prior to WLST, participates in the surgical time-out, and verifies room set-up prior to exiting the OR for WLST. The transplant recovery team should be provided an area adjacent to the OR to wait for death declaration. Depending on the organs allocated for transplant, the wait time for death to occur could range from 30 to 120 minutes or longer. However, this time frame is specific to the donor, the organs to be recovered, and the transplant team. It is also subject to change as advances in organ preservation are made; therefore, hospitals should collaborate with their OPO to establish policies related to current wait times.

Once death is declared, the transplant recovery team may enter the room. The surgical technician should be prepared to assist with gowning and gloving so as to minimize WIT. A transplant surgeon typically performs a median sternotomy and midline abdominal incision. The surgeon will quickly dissect to the aorta, insert a cannula (provided by the OPO recovery team) distal to the renal arteries and clamp the aorta. This is considered “cross-clamp” time and is documented by the hospital and the OPO and transplant recovery teams. Cross-clamp time marks the end of WIT and the start of cold ischemic time (CIT). The cannula is connected to cold preservation solution provided by the OPO or transplant recovery team, which is then rapidly infused into the aorta to flush the organs clear of blood. Large suction canisters (e.g., Neptune or Dornoch) with multiple suction cannulas are utilized after cross-clamp. The abdominal and thoracic (if thoracic organs are to be recovered) cavity will be filled with slush (ice) to rapidly begin the cooling process.⁷ Slush machines, or large basins for hospitals without slush machines, should be set up prior to WLST. The OPO and/or transplant recovery team typically provides some (if not all) of the slush used for cooling and packaging organs.

Once the preservation solution has cleared as much of the blood out of the organs as possible, the surgeon(s) continues to dissect the intended organs for transplant and associated vessels free of the body. The organs are then removed from the body to the back table where they will be assessed and measured for anatomy. In addition, pictures are typically taken by the OPO recovery team for potential reference at a later time. The OPO or transplant recovery team will carefully package each organ in slush and sterile containers and transfer the packaged organs to an approved transport carrier (corrugated waxed box, cooler, or organ pump). The OPO recovery team is responsible for ensuring that each organ is properly labeled prior to the organ leaving the OR. The organs are then transported to the intended recipient at the transplant hospital as quickly as possible. The OPO recovery team and/or hospital should have someone available to assist the transplant recovery team to the changing lockers and to the location of their transportation vehicle to decrease time navigating the hospital.

According to the OPTN,² hearts and lungs can tolerate, on average, four to six hours of CIT; livers, intestines, and pancreata can last approximately 12 – 18 hours, and kidneys 24-36 hours.

Organ Biopsies

Kidney biopsies should be performed on DCD donors, 18 years of age and older who meet at least one of the following criteria per OPTN Policy:²

• Anuria or urine output less than 100 ml in 24 hours
• Donor received hemodialysis or other renal replacement therapy
• History of diabetes or Hemoglobin A1C 6.5 or greater
• A Kidney Donor Profile Index (KDPI) of 85% or more
• Donor age 60 years or older
• Donor age 50-59 years and has at least two of the following criteria:
  • History of hypertension
  • Cerebrovascular Accident (CVA) as cause of death
  • Final serum creatinine greater than or equal to 1.5 mg/dl

Liver biopsies may also be requested, for instance, if the donor has a high Body Mass Index (BMI) or a history of alcohol abuse.

The OPO coordinator is responsible for ensuring that biopsies are obtained per OPTN policy. A rapid turnaround of biopsy results is necessary prior to organ acceptance; consequently, hospital pathology should be prepared to expedite the processing and preparation of the biopsy for interpretation. Most commonly a wedge biopsy for a frozen section will be submitted to pathology.⁸

In recent years, OPOs have addressed the complexity of renal biopsy interpretation by contracting with renal pathology specialists and/or utilizing telepathology services. Unfortunately, there remains limited access to these specialized services for approximately half of the requested kidney biopsies.⁸ It is imperative that hospitals and OPOs establish clear protocols for the coordination of biopsy preparation and interpretation to ensure timely availability of results.

OR Preparation Checklist & OR Set Up

The following checklist and set up outlines considerations for OR preparation. This is not an exhaustive list. Collaborate with your partnering OPO for specific needs:

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MARK LAMBIE/EL PASO TIMES

Honor Practices

Many organizations honor donation decisions through raising Donate Life flags during donor cases, Honor Walks from the ICU to the OR, and/or a Moment of Silence in the OR before WLST. Collaborate with your partnering OPO to develop protocols for flag raisings, Honor Walks, and the Moment of Silence, or any other practice that honors the generosity of the donor and the legacy that is being created.

Honor Walk: A practice that provides families, friends, and medical teams an opportunity to honor the generosity of the potential donor by lining the transportation route from the ICU room to the location of WLST when the donor is transported.

Donate Life Flag Raising: A practice that honors the donor through the raising of the Donate Life Flag during the donor case. Some hospitals may even present the flag to the family after the case or families may want to take a photo of the flying flag.

Moment of Silence/Moment of Silence reading: A practice that honors the person donating organs through reading a statement from the family and taking a few minutes in silence with the hospital, OPO, and transplant recovery team before WLST.