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U.S. Department of Health and Human Services Recommendations 29-35

The Committee (ACOT) met on November 6-7, 2003, in Washington, DC, and unanimously agreed on the following seven recommendations:

Recommendation 29: HHS should fund necessary research initiatives, and convene a national consensus conference, updating the criteria involved in end of life issues related to the determination of death in the context of organ donation and transplantation. The three specific areas for review would be brain death, cardiac death, and imminent death.

Brain death and cardiac death involve two different but equally appropriate definitions of death, yet there is widespread confusion and uncertainty regarding their application, and some inconsistency in protocols employed in the determination of death. (Interestingly, while the public appears to have a clearer understanding of the concept of brain death, only about 1% of deaths declared are by brain death criteria.) The questions raised here are not unique to the issues of organ donation and transplantation, but have been highlighted by the advances in those fields, and the concomitant necessity to more clearly define the related concept of imminent death.

  • Brain Death: ACOT recommends that a Uniform Declaration of Death Protocol should be established and research initiatives essential to accomplishing this goal should be funded. The Department of Health and Human Services should encourage the American Academy of Neurology and other interested medical specialty organizations (e.g., American Academy of Pediatrics, Society for Critical Care Medicine [SCCM], Child Neurology Society, American Association of Neurological Surgeons, Congress of Neurological Surgeons, American Neurological Association, and so forth) to participate in the consensus conference and to assist in updating the practice guideline for brain death determination. Both the American Academy of Neurology’s Practice Parameter for Brain Death Determination and the American College of Critical Care Medicine’s Intensive Care Guidelines and Consensus could serve as a basis for preliminary discussion.

    HHS and other participating associations should work together with hospitals, organ procurement organizations, the American Hospital Association, and other interested groups to develop tools for the documentation of brain death determination and to promote consistent practices among hospitals.
  • Cardiac Death: ACOT recommends that a Uniform Declaration of Death Protocol should be established and research initiatives essential to accomplishing this goal should be funded. It is extremely important for families and all others involved in donation after cardiac death (DCD) to understand that DCD occurs only after the patient or family has decided to withdraw life-sustaining therapies, for reasons entirely apart from any potential for organ donation. Therefore, a certain amount of modeling or walk-through of what is involved will be essential at institutions contemplating the institution of a DCD protocol. A standard template for DCD needs to be developed, and the consensus conference should generate a white paper that could be used for professional and public education. With regard to DCD, the key problems for the conference to consider would include: (a) why the clear definition of legal and ethical responsibilities spelled out in the IOM reports and the SCCM guidelines have not achieved widespread acknowledgement or integration into clearly accepted procedural protocols; and (b) the lack of professional and public education and understanding associated with DCD.

    The two extensive DCD reports by the Institute of Medicine need to be reviewed and the impediments to the implementation of the recommendations within those reports must be identified and analyzed. In this regard, it should be noted that ACOT specifically endorses the current efforts of the HHS Breakthrough Collaborative toward DCD identification and referral.

    ACOT believes that it is time for a requirement that all Class A hospitals at least begin the necessary ethical conversation about DCD, involving both ICU professionals and ancillary caregivers. The parties involved should indeed include hospital leadership, ICU health care team members; transplantation surgeons, anesthesiologists, OR nurses and staff, Pastoral Caregivers, local community and church leaders, as well as OPO staff, public health officials, and families who have or have not been offered the opportunity to participate in DCD. Each such hospital should be required to actively and seriously consider the development, public promulgation, and implementation of protocols for transplantation from deceased donors after cardiac death. These protocols should focus on management in the ICU.
  • Imminent Death: ACOT recommends that HHS take the steps necessary to ensure that all potential organ donors are referred to OPOs in a timely fashion, including defining when a referral should be made to an OPO and establishing an appropriate enforcement mechanism to assure compliance. Two existing impediments to timely referrals have been identified. First, OPOs are not consistently notified before the withdrawal of all life sustaining therapies; there should be a requirement that the OPO be notified prior to such life sustaining therapies being withdrawn from any patient. Second, the lack of a clear definition of imminent death hinders the timely referral of potential donors; there need to be clear parameters concerning imminent death. Some physicians may be reluctant to adopt certain clinical triggers for a declaration of imminent death; this is why a consensus conference is needed to bring all relevant parties together for purposeful discussion. The pathway must be clearly defined so that OPOs may be involved at the appropriate time, and these standards should be enforced by an appropriate designated entity.

    ACOT discussions suggest that the appropriate trigger could be the progression from aggressive care to palliative care. We need to figure out that exact desirable point in the process for OPO notification so that we can clearly specify it. This point is one of delicate balance in that it establishes a time before which the OPO should not be involved, while at the same time providing that there is accountability for assuring that the OPO is indeed contacted when it is appropriate to do so. It is thus essential to establish in resulting protocols precisely who on hospital staff is required to contact the OPO. Commitments to action and safeguards against potential conflict of interest must be put in place to (1) ensure that medical decisions are isolated from any decisions related to donation; (2) maintain complete separation between the transplant team and the patient care team; and (3) make certain that no discussion of donation with the family occurs prior to a decision to withdraw support.

    ACOT calls specific attention here to the following two questions and answers currently promulgated by the Centers for Medicare and Medicaid Services (CMS) Web site which have attempted to address the issue of imminent death. We do feel, however, that it is time to go beyond the below recommended discussion between OPOs and hospitals, and time now for a consensus conference that brings all relevant parties to the table in order to resolve this important issue. Moreover, upon reaching this consensus, it will be imperative for each of the groups involved to assure that their respective memberships are thoroughly educated on the matter.
    • Q. 11 What does "imminent death" mean? Does it mean the hospital has to call if a patient is expected to die, but the patient is not on a ventilator?

      A. 11 Based on suggestions from both the OPO and physician communities (including the Association of Organ Procurement Organizations and the Council on Scientific Affairs of the American Medical Association), we have developed the following guidelines for hospitals and OPOs to use in developing a mutually agreed upon definition of "imminent death." Although neither the statute nor CMS’s regulations define "imminent death," the definition might include:
      • A patient with severe, acute brain injury:
        • Who requires mechanical ventilation;
        • Is in an Intensive Care Unit or Emergency Department; AND
        • Has clinical findings consistent with a Glasgow Coma Score (GCS) that is less than or equal to a mutually-agreed-upon threshold;or
        • For whom physicians are evaluating a diagnosis of brain death; or
        • For whom a physician has ordered that life sustaining therapies be withdrawn, pursuant to the family’s decision.

      Discussion: In our September 1999 response to this question, we declined to define "imminent death." We said that such a definition involves a medical judgment that should be left up to hospitals and OPOs. We urged OPOs and hospitals to work together to develop a definition and a protocol for referral of imminent deaths. The only guidance we provided was that a definition for "imminent death" would likely include a brain dead or severely brain-injured individual on a ventilator.

      However, we have found that some hospitals have not developed protocols for imminent death and are not notifying their OPOs about imminent deaths. We believe this may be due to hospitals' confusion about what "imminent death" means. Therefore, we are providing guidance that OPOs and hospitals can use to develop a definition that includes specific triggers for notifying the OPO about an imminent death.

      In determining the appropriate threshold for the GCS, it is important to remember that if the threshold is too low, there may be too many "premature" deaths or situations where there is loss of organ viability. The Association of Organ Procurement Organizations suggests a GCS of < 5. However, some OPOs and hospitals use a GCS < 4 or < 3.

      Note that a patient with a "severe, acute brain injury" is not always a trauma patient. For example, post myocardial infarction resuscitation may result in a heart beating patient with no brain activity.

      The definition agreed to by the hospital and the OPO may include all of the elements listed above or just some of the elements. The definition should be tailored to fit the particular circumstances in each hospital. Whatever definition is used, the most important considerations are:

      Contacting the OPO early enough so that organ viability can be preserved. The OPO must assess the potential donor's medical suitability, discuss donation with the family, obtain consent, and arrange for placement and recovery of the organs. The OPO must begin this process early enough so that there is a strong likelihood the potential donor's organs will remain viable until recovery and transplantation can take place (assuming there is no disease process the OPO identifies that would cause the organs to be unsuitable);

      Collaborating to develop a definition of "imminent death" acceptable to both the OPO and hospital. In some hospitals, there is disagreement between the OPO and hospital staffs regarding the appropriate time for the OPO to begin assessment of the potential donor. From the OPO's perspective, early referral and assessment of the donor is crucial. However, physicians and nurses who are caring for the potential donor may regard the arrival of the OPO as a signal that they are expected to abandon their roles as care givers and "give up" on the patient. Unfortunately, the tensions caused by these disagreements are hampering donation in some hospitals. We urge OPOs and hospitals to work together to develop a definition for "imminent death" that strikes a balance between the needs of the OPO and the needs of the hospital's care givers to continue treatment of a patient until brain death is declared or the patient's family has made the decision to withdraw supportive measures. Collaboration between OPOs and hospitals will create a partnership that furthers donation, while respecting the perspective of the hospital staff.

    • Q. 12 What does it mean for a hospital to notify the OPO about a death or imminent death in a "timely manner?"

      A. 12 In our September 1999 response to this question we stated, "Timely notification means that a hospital must contact the OPO by telephone as soon as possible after an individual has died, has been placed on a ventilator due to a severe brain injury, or who has been declared brain dead. That is, a hospital must notify the OPO while a brain dead or severely brain-injured, ventilator-dependent individual is still attached to the ventilator and as soon as possible after the death of any other individual, including a potential non-heart-beating donor. Even if the hospital does not consider an individual who is not on a ventilator to be a potential donor, the hospital must call the OPO as soon as possible after the death of that individual has occurred."

      We have found that some hospitals are not notifying their OPOs about deaths and imminent deaths in a timely manner. This is of particular concern in the event of an imminent death if a hospital contacts the OPO after a patient is removed from the ventilator or contacts the OPO so late in the process that the patient's organs have started to deteriorate. Therefore, we are adding the following clarification. Hospitals should follow this or a similar protocol to ensure that the OPO can arrive at the hospital with sufficient time to assess the patient's donor potential while organs are still viable. We believe that referral by a hospital to the OPO is timely if it is made:

      As soon as it is anticipated a patient will meet the criteria for imminent death agreed to by the OPO and hospital or as soon as possible after a patient meets the criteria for imminent death agreed to by the OPO and the hospital (ideally within one hour); AND

      Prior to the withdrawal of any life sustaining therapies (i.e., medical or pharmacological support).

      Whenever possible, referral should be made early enough to allow the OPO to assess the patient's suitability for organ donation before brain death is declared and before the option of organ donation is presented to the family of the potential donor. Timely assessment of the patient's suitability for organ donation increases the likelihood that the patient's organs will be viable for transplantation (assuming there is no disease process identified by the OPO that would cause the organs to be unsuitable), assures that the family is approached only if the patient is medically suitable for organ donation, and assures that an OPO representative is available to collaborate with the hospital staff in discussing donation with the family.

Recommendation 30: HHS should review the results of the research conducted and national consensus conference convened in response to Recommendation 29 and seek to resolve the many reimbursement issues related to the determination of death in the context of organ donation and transplantation. These deal with determination of brain death, cardiac death, and imminent death, particularly with regard to ECD organs. CMS and other appropriate HHS agencies should also review their procedures with regard to living donors to ensure that living donors are fully reimbursed, and further that living donors are not disadvantaged with respect to their other insurance needs.

ACOT is recommending that HHS re-examine government reimbursement mechanisms, and further encourage private payers to re-examine their guidelines for the coverage of costs associated with procurement and transplantation, to ensure that reimbursement rules do not discourage the procurement of organs from any deceased donor whose organs are suitable for transplantation. The present reimbursement system was formulated at a time when the transplant community was doing something very different from what it is doing now. The consensus conference proposed in Recommendation 29 will examine the system in light of how the transplant system works today. The goal of Recommendation 30 is therefore to similarly assure that the reimbursement system accurately reflects current practice.

  • ECD. Several flaws in current reimbursement methodology have been identified. The current Centers for Medicare and Medicaid Services (CMS) reimbursement for the transplant experience, for example, creates undesirable disincentives to using Expanded Criteria Donor (ECD) organs, whether obtained from brain death donors or cardiac death donors. Although the long-term outcomes of using ECD organs appears good, and such usage is desirable in the context of ongoing organ shortages, it is clear and understandable that the patients in whom these organs are placed experience more complications post-operatively, and thus have a more expensive hospital course. At present, if an OPO aggressively pursues the transplantation of expanded criteria donors, as, for example, in transplanting two kidneys into a single patient, the OPO is effectively punished financially by having to pay back Medicare rather than rewarded for utilizing an additional organ. Moreover, to determine suitability of organs for transplantation, certain diagnostic tests must be performed and additional costs are thereby incurred; such costs should be covered, whether or not the organs ultimately prove suitable for transplantation. Therefore, CMS must develop a plan of action related to revising the current unitary transplantation Diagnostic Related Group (DRG) reimbursement structure, along with a review of the Medicare Cost Report. One possibility might be to come up with a sub-DRG to define a high-risk donor, and the OPTN and/or SRTR could provide the necessary data to CMS to demonstrate that the present DRG is presently very under-weighted.
  • DCD. Similarly, the current CMS reimbursement scheme for transplants creates undesirable disincentives to using Donation after Cardiac Death (DCD) organs. There should be coverage/reimbursement of additional costs occasioned by approved DCD protocols. Presently, donor hospitals are not supposed to get reimbursed for costs prior to brain death; families or their insurers bear those costs. Thus, CMS does not reimburse the OPO for any costs until after declaration of brain death; this criterion, however, is irrelevant to DCD because the brain death criterion does not apply to cases involving cardiac death. For DCD, where should the break point occur-when the decision is made to transition to comfort care, when life support is withdrawn, or at some other point? It seems appropriate to facilitate actions (e.g., instrumentation, obtaining consent for catheter placement) that meet the donor's wishes to donate organs. With DCD donors in particular, if the family decides to withdraw life support, OPOs are under an obligation to determine whether the patient might be a suitable donor. Tests to answer this question are therefore often performed early in the process. This common practice is described in the "Cost of Altruism" paper. Practices are changing because referrals are occurring earlier in the death process. OPOs must make decisions about donor suitability before approaching the family. Changes are necessary in order to preserve a designated donor's right to donate and/or the family's right to consent to donation. If a detailed protocol were in place, as is envisioned with respect to Recommendation 29, we would have a better idea as to where to apply these recommendations and how to suggest specific changes in the reimbursement structure. This dilemma is arising because the practice of donation is changing; practices are in turn changing because referrals are occurring earlier in the death process. In the past, OPOs did not get a call until both brain death exams were done; later, they would get a call after the first exam; still later, they would get a call when it appeared that death was imminent. Yet, present reimbursement rules do not reflect this reality. The OPO is being called in earlier than ever in order to determine whether the patient might be a donor. Since, in such instances, the OPO is only providing an option for families, it would appear logical that it be reimbursed for its efforts.
  • Living Donors. With respect to living donors, a category that represents an increasing percentage of donor organs available for transplantation, ACOT recommends that living organ donors be fully reimbursed for any and all direct and indirect costs occasioned by the donation. Furthermore, ACOT recommends that a needs assessment be undertaken to determine whether, and to what extent, living donors experience difficulties obtaining or maintaining health, life and disability insurance. (A specific question should be raised about mental health coverage because a lack of parity between mental and other medical coverage remains a concern.) Government and private payer policies here too need to be re-examined to ensure that all appropriate costs associated with living organ donation are fully reimbursed.

In sum, DCD and brain death acquisition costs, particularly for ECD organs, as well as all living donor travel and lodging expenses, should be reimbursed and CMS needs to revise its rules to assure that such reimbursement occurs. ACOT further recommends that, in order to fully assure that policies and practices in this regard are kept up to date, HHS direct the OPTN and the SRTR to provide annual reports summarizing significant financial and insurance data on relevant socio-economic groupings.

Recommendation 31: The OPTN should continue its efforts at developing a national standardized transplant quality of life (QOL) tool that could be made available to all transplant centers for assessing transplant end points in addition to mortality. In this context, transplant centers should be encouraged to establish and implement back to work programs for transplant recipients and living organ donors because of their proven ability in improving post-transplant quality of life, and the OPTN should consider including such programs in their criteria for transplant centers.

Measures of transplant outcomes are very limited presently: graft loss, patient survival, hospitalization. For real human beings, there are many stages in between. It behooves us to study what the appropriate tools would be to assess the economic and quality of life (QOL) status of patients post-transplant. Moreover, since we need to know, if only in terms of allocation, whether we are doing a service or disservice by transplanting some patients, we need to assess QOL at various time points before and after transplant.

One significant QOL measure is work. ACOT believes that all transplant centers should develop, in conjunction with their state's vocational rehabilitation department, a back to work program (sometimes referred to as a return to work program) for transplant recipients, and, where applicable, for living donors. The back to work referral should begin prior to transplantation. It may even be useful to begin vocational evaluation while patients are still on dialysis, especially since many dialysis patients have been out of work for many years.

Vanderbilt University's back to work program demonstrates the interrelationship of such a vocational effort and QOL. The patient satisfaction survey that Vanderbilt has conducted demonstrates that optimal employment following liver transplantation is associated with a higher quality of life. Conversely, lower QOL is associated with sub-optimal employment and unemployment. A report on this program received by ACOT indicates that unemployment nationally among transplant patients is 62%. Post-transplant Social Security Disability costs run about $10,800 per patient annually. The median return-to-work time is 3.5 years. Each 100 patients served by vocational services can therefore save more than $1 million if we can get them back to work a year earlier. The following non-financial aspects should also be noted:

The human costs of post-transplant unemployment include:

  • Incomplete recovery process
  • Sick role reinforced
  • Damaged self-confidence
  • Disruption of family and social structure
  • Financial problems.

Vocational specialists can help patients tap into such resources as:

  • State vocational rehabilitation
  • Ticket-to-work programs
  • Social Security disability employment supports
  • The Health Insurance Portability and Accountability Act of 1996 (HIPAA), which prohibits discrimination in employer health insurance because of disability or preexisting condition
  • American with Disabilities Act (ADA) technical assistance.

Recommendation 32: HHS should fund or conduct a review of all underlying issues related to recipient selection criteria.

The proposed study should include an unbiased review of the literature that examines and comments upon the legal, ethical, and medical bases for some clinical and all non-clinical transplant recipient selection criteria, as well as related issues. ACOT recommends that the Secretary employ whatever means are deemed appropriate to conduct such a review, whether it should involve the commissioning of a study (perhaps by the Institute of Medicine) to explore and frame the underlying issues and/or the convening of a consensus conference to discuss attempts to resolve competing viewpoints.

It is apparent that public dissatisfaction and sometimes expressed cynicism with elements of the donation and transplantation system relate to concerns about the propriety and appropriateness of present recipient selection criteria. While these and many related issues have not generally been discussed openly within the donation and transplant communities, everyone is aware that the public frequently raises these and many related concerns, as indeed do many health professionals.

Some of the issues involved may reflect broader health and equity concerns than are involved in transplantation alone, while others may exist only because of the supply shortages that uniquely affect our field of concern. Many physicians feel that widely accepted ethical principles provide sufficient guidance or that their reading of the Hippocratic Oath settles all individual patient selection issues. Nevertheless, the goals of a nationwide patient selection system are not necessarily resolved in a similar way, and, indeed, may call for differential criteria to be employed. Note well that ACOT is not by this Recommendation stating a preferred end result for the review it is requesting, only that such an impartial and thorough review be conducted and reported openly.

Recommendation 33: So as to identify more kidneys, and more appropriate kidneys, that can be used for transplantation, HHS should fund a clinical multi-center trial to determine whether, and under what circumstances, pre-transplant kidney biopsies are a predictor of post-transplant kidney function.

Some transplant physicians use biopsies to determine if a kidney can be used and to predict post-transplant function. One small study has been published, and a second, Italian, paper suggests as well that such biopsy results are not valid predictors. However, there are at present no comprehensive data correlating post-transplant function with biopsy outcomes. The experiences of transplant physicians and surgeons serving on ACOT indicate that some kidneys with unfavorable biopsies function well after transplant. Retrospective data analyses, followed by prospective multi-center clinical trials, should be undertaken to better define the predictive value of pre-transplant biopsies for the purpose of increasing the number of kidneys available for transplantation.

Recommendation 34: HHS should review and report on factors affecting multicultural donation, and present data on transplantation by race, ethnicity, sex, and region.

ACOT Recommendation 9 was "That research be conducted into the causes of existing disparities in organ transplant rates and outcomes, with the goal of eliminating those disparities." ACOT is pleased that the Secretary supported this Recommendation and that HHS has announced initiatives in this area. Recommendation 34 is for some specific follow-ups to these activities, to include as well the donation side of issues affecting multicultural populations:

  1. HHS should review and report the results of funded grants that have examined factors affecting multicultural organ donation, as well as identify and explore any programs that have been successful in enhancing minority donation. Programs in existence within the procurement community and those identified through the Division of Transplantation (DOT) grant program should both be highlighted. DOT has funded numerous grants focusing on multicultural organ donation. The final reports for these grants should be reviewed in a timely manner and factors identified to distinguish successful from unsuccessful programs. Results should be reported to the procurement and transplant community and should be examined closely for transferability because a program that works in one location may not work in another.
  2. The SRTR (and any other relevant regulatory body with information regarding this issue, including the Centers for Medicare and Medicaid Services) should coordinate the collection of data and develop an annual report that examines referrals for transplantation, transplant rates, waiting times, and outcome by race, ethnicity, economic status, sex, and region. The results should as well be reported to the procurement and transplant community. This reporting should be mandatory so that the data can be monitored on a prospective or concurrent basis so as to illuminate disparities.
  3. The NIH research agenda that the Secretary has established should focus on these issues with a view to suggesting biomedical solutions beyond epidemiological studies. This should include research as to whether there might be significant genetic differences in biological responses to allografts.

Recommendation 35: HHS should conduct an evaluation of materials presently used by various centers and organizations across the nation to educate potential transplant recipients; the purpose of this review would be to develop improved patient information and education as part of the informed consent process. HHS should also ensure that appropriate hospital personnel undergo annual training in the organ donation process; such training would include OPO reporting requirements.

ACOT has previously made several Recommendations urging additional education and information for both patients (ACOT Recommendations 1, 3, 4, and 8) and transplant professionals (ACOT Recommendation 11). Recommendation 35 is designed to build upon those Recommendations in specific ways for both patients and professionals.

  • Patients: At present, too many patients report that, prior to receiving their transplants, they had not been adequately informed about what to expect post-transplant. HHS should conduct or fund a research project or grant designed to review existing pre-transplant information packages and evaluate the perception of recipients post-transplant assessing the value of the educational efforts to which they were subject. As a result of the information gleaned from such a project or grant, a template or set of guidelines should be developed regarding the kind and quality of patient information/education which should be incorporated into the informed consent process, possibly as a part of the ongoing HHS Best Practices Initiative.

Potential organ recipients and their families also need to be aware of and understand any complications that might occur after the patient undergoes a transplant. Transplantation teams need to help patients and their families in the advance care planning process. They need to discuss the possibilities of life-sustaining interventions and the potential need for intensive care, as well as the possibility that the patient could die or have an unacceptably poor outcome after transplantation. Patients and their families in turn should be encouraged to describe in detail their wishes or goals for care. Kidney patients should also be informed about the possibility of having to go back on dialysis for a time during the post-transplant course. Educational materials should describe the range of outcomes, from very good to very poor, including death. Patients have a need to know about the spectrum of possibilities that can occur post-transplant. Neurological complications from immunosuppressive therapy, mood changes, and complications concerning pregnancy all need to be more fully described in patient education materials. It might also be desirable to develop an educational video, which could be widely distributed by HHS, including interviews with a range of patients, to more fully explain what should be expected post-transplant.

As ACOT noted with respect to its Recommendation 8, we could also do far more education about the transplant experience while people are on dialysis awaiting transplant. The key importance of fully educating patients beforehand is not only to provide a knowing consent to procedures, but also to encourage patients to become their own best advocates and empower them to be more involved in their own care.

  • Transplant Professionals: Training on the organ donation process (including OPO reporting requirements) should be one of the yearly mandatory updates that hospital personnel are required to take, just as they presently undertake annual training, for example, in CPR. Yet, even most hospital personnel are unaware of the fact that more lives are saved annually through organ donation than through CPR. The training updates proposed here should be tailored to meet the needs of the area where the employee works, but virtually all hospital personnel should comply with such a training requirement since the public tends to ask relevant questions of almost all hospital employees. The training should vary according to need; i.e., ICU, ER and OR physicians and staff — who are more likely to actively participate in organ donation — should receive full updates, whereas other staff should be trained primarily on where questions should be referred.

For most hospitals, training is presently available from the local OPO, but it is offered sporadically. ACOT is here recommending that the process of OPOs disseminating appropriate education to relevant personnel in the hospital become more regularized.

Date Last Reviewed: