Clarification of the Term "Hospital"

Q1. Are psychiatric hospitals, rehabilitation hospitals, cancer centers, or small rural hospitals exempt from the regulation since they are unlikely to have potential donors?

A1. The regulation applies to all Medicare hospitals, including psychiatric hospitals, rehabilitation hospitals, cancer centers and small rural hospitals. The regulation applies to psychiatric hospitals, rehabilitation hospitals, cancer centers and small rural hospitals because these hospitals do have some donation potential, and including them ensures that no potential donors are missed. Some small rural hospitals have ventilators and may have potential organ donors. Psychiatric hospitals, rehabilitation hospitals, cancer centers, and hospitals without ventilators may have potential tissue or eye donors.

Q2. Does the regulation apply to Veterans Administration (VA) hospitals, military hospitals, Indian Health Service hospitals, or prison hospitals?

A2. The regulation does not apply to VA hospitals, military hospitals, or prison hospitals because they are not Medicare hospitals. However, the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) has adopted the provisions of the regulation in their standards for hospitals. Therefore, VA hospitals, military hospitals, or prison hospitals that are accredited by JCAHO are required by JCAHO to meet their standards for organ, tissue, and eye donation. (Revised 9/99.)

The regulation applies to Indian Health Service hospitals.

Q3. Are entities such as hospices, skilled nursing facilities, long term care facilities, or home health agencies covered by this regulation if they are located within or considered to be part of a hospital?

A3. No. The regulation covers only Medicare-certified hospitals. Although an entity such as a skilled nursing facility may be located within a hospital or may do business using a hospital's name, it is not covered by the regulation.

Q4. Should the death of a patient receiving skilled nursing services in a "swing bed" be reported to the OPO?

A4. Swing beds being used for skilled nursing are not covered under the regulation. Therefore, a hospital is not required to notify the OPO about the death or imminent death of a patient who was receiving skilled nursing services in a swing bed. A hospital is required to notify the OPO about the death or imminent death of a patient who was receiving hospital services in a swing bed.

Q.5 What is a critical access hospital (CAH)? Does the regulation apply to this type of hospital?

A.5 CAHs are a separate provider type with their own conditions of participation at 42 CFR 485.601-645. They were established under §1820 of the Social Security Act to ensure that certain medically under served rural and urban areas would have access to hospital care. With the exception of CAHs with swing bed agreements for provision of skilled nursing services, a CAH is permitted to maintain no more than 15 inpatient beds. Generally, a CAH must discharge or transfer a patient within 96 hours following admission.

The regulation does not apply to CAHs. However, they are covered by §1138 of the Social Security Act, which requires CAHs to have written protocols for identification of potential organ donors. They are required to assure that families are made aware of the option of organ or tissue donation, encourage discretion and sensitivity toward families, and notify the OPO about of potential organ donors. (Revised 9/99.)

Clarification of Terms "Hospital Death" and "Imminent Death"

Q6. Are hospitals required to report an abortion, miscarriage, fetal death or stillbirth?

A6. Hospitals should not report an abortion, miscarriage, or fetal death. If a death certificate is required for a stillbirth, the hospital should report the death to the OPO.

Q7. Some States have a "fetal death certificate," which is different from a standard death certificate. A fetal death certificate is sometimes issued for stillbirths (depending upon the gestational age), but it becomes part of the mother's medical record, and there is no separate medical record created for the stillborn child. Is it necessary for hospitals to notify OPOs about stillbirths if a fetal death certificate is issued instead of a standard death certificate?

A7. The hospital should check with the tissue bank to determine if usable tissues can be recovered from a stillborn child of the gestational age at which their State requires a fetal death certificate. If no usable tissues can be recovered, there is no need for the death to be reported. If usable tissues can be recovered, the hospital must report the death to the OPO. (Revised 9/99.)

Q8. Are hospitals required to report the death of an individual who is dead on arrival at the hospital, for example, an individual who dies in an ambulance on the way to the hospital but is pronounced dead in the emergency room or an individual whose body is brought to the hospital by a funeral director to be pronounced dead?

A8. If the State in which the hospital is located and/or the hospital itself construes the death for legal purposes as a death that occurred in the hospital, the death should be reported to the OPO.

Q9. 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?

A9. HCFA did not propose a regulatory definition for imminent death, because we believe defining "imminent death" involves making a medical judgement that is properly left up to OPOs and hospitals. Each OPO should work with the hospitals in its service area to develop a definition for "imminent death" and a protocol for referral of imminent deaths. However, we would expect that a definition of "imminent death" would include a brain dead or severely brain-injured individual on a ventilator.

Notification Issues

Q10. What does it mean for a hospital to notify the OPO about a death or imminent death in a "timely manner?"

A10. 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.

Q11. If an OPO does not accept organs from donors past a certain age, is it acceptable for the OPO to instruct hospitals to notify them of the deaths of these individuals on a periodic (e.g., weekly or monthly) basis rather them calling the OPO about these deaths immediately?

A11. No. Hospitals may not use "batch" reporting for deaths by providing a list of deaths to the OPO on a periodic basis, even if instructed to do so by the OPO. A hospital must notify the OPO as soon as possible about the death of every individual who dies in the hospital. The regulation does not permit any exclusions from this requirement.

Q12. Is it acceptable for an OPO to instruct hospitals to notify them directly only if they have a "potential donor" and notify a third party, such as a State health department about all other deaths. The health department would then notify the OPO about the death. This avoids the hospital making two phone calls, one to the OPO and one to the State health department to report the death.

A12. No. It is the responsibility of the OPO to screen donors for medical suitability. Although the regulation permits hospitals to notify "a third party designated by the OPO" in place of the OPO, the preamble makes it clear that the third party is expected to be an entity that will act in the OPOs place by accepting all referral calls for the OPO (24 hours per day or only during certain hours) and screening them for medical suitability. Under the arrangement described in this question, the hospital would determine medical suitability in place of the OPO by referring directly to the OPO only those individuals the hospital believes to be potential donors. Even if the State health department referred the remaining deaths to the OPO promptly, there exists the possibility that a potential donor would be missed if this arrangement were to be used.

Q.13 Is it permissible for the hospital to notify the tissue bank or eye bank about a death and ask the tissue bank or eye bank to notify the OPO or does the hospital have to notify the OPO directly?

A.13 The regulation specifies that the hospital must notify the OPO or "a third party designated by the OPO." The language permitting the use of a third party was added to the final rule to make it clear that the regulation does not preclude continuation of successful community referral systems, whereby hospitals can refer potential donors by making only one telephone call. However, in providing OPOs the latitude to designate a third party, our assumption was that an OPO would designate a third party with staff specially trained to triage the calls and contact the OPO about potential organ donors. Putting a process in place whereby every referral call from the hospital is passed through an agency whose staff is not specially trained to screen referrals for potential organ donors runs the risk that a potential organ donor will be overlooked. (Revised 9/99.)

Q14. If a hospital wants to be able to inform the OPO, a tissue bank, and an eye bank about a death by making only one call, is the OPO required to notify the tissue bank and eye bank selected by the hospital about the death?

A14. Yes. An OPO, as the "gatekeeper" receiving notification about every hospital death, must notify the tissue bank and eye bank chosen by the hospital about potential tissue and eye donors. This is based on the OPO regulations at 42 CFR 486.306(l), which require OPOs to:

"Have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all usable tissues are obtained from potential donors."

If requested to do so by the hospital, the OPO must determine medical suitability for tissue and eye donation and notify the tissue and/or eye bank, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital. The OPO must notify the tissue bank and/or eye bank selected by the hospital about potential tissue and eye donors, even if the OPO itself offers tissue and eye recovery services in addition to organ recovery services.

Q.15 If a patient is transferred from one hospital to another, (e.g., an accident victim is treated in the emergency room of a small rural hospital and transferred to a hospital with a trauma center or a patient in a psychiatric hospital is transferred to an acute care hospital for treatment of a medical condition), must the staff from the hospital from which the patient is transferred notify the OPO if they believe death is imminent?

A.15 Notification of the OPO is the responsibility of the hospital to which the patient is transferred.

Q.16 May a hospital specify to the OPO that they want only certain categories of individuals referred as potential tissue or eye donors to the tissue bank and eye bank with which the hospital has agreements?

A.16 Yes. However, the hospital should collaborate with the tissue bank and eye to specify donor criteria that ensure all usable tissues are recovered. As outlined in the answer to Q.30, there are numerous sources a hospital can consult to determine acceptable criteria. (Revised 9/99.)

Agreements Between Hospitals and Tissue/Eye Banks

Q17. The regulation requires hospitals to have an agreement with a least one tissue bank and at least one eye bank. If the hospital's OPO also provides tissue procurement services, is it acceptable for the hospital to have an agreement with the OPO to provide both organ and tissue services, or must the hospital have a separate agreement with a tissue bank?

A17. It is not necessary for a hospital to have a separate agreement with a tissue bank if it has an agreement with its OPO to provide tissue procurement services nor is it necessary for a hospital to have a separate agreement with an eye bank if its OPO provides eye procurement services. The requirements of the regulation are satisfied as long as the hospital has an agreement with one or more entities to ensure that all usable tissues and eyes are recovered.

Q18. If an OPO presents a hospital with an agreement that specifies all organs and tissues will be recovered by the OPO, is the hospital required by the regulation to accept such an arrangement?

A18. No. Hospitals are required only to have an agreement for recovery of organs with the OPO designated by the Secretary unless the hospital has submitted and had approved a waiver to work with a different OPO. The hospital is not required to use the OPO for tissue or eye procurement but is free to have an agreement with the tissue bank and eye bank of its choice.

Q19. The answer to the previous question refers to a waiver a hospital can obtain to work with an OPO other than the OPO to which the hospital has been assigned. What is the process hospitals use to request a waiver?

A19. Under some circumstances, HCFA will permit a hospital to have an agreement with an OPO other than the OPO designated for the service area in which the hospital is located. The requirements are found at 42 CFR §486.316(d)-(g). To qualify, the hospital must submit data to HCFA showing that (1) the waiver is expected to increase organ donations; and (2) the waiver will ensure equitable treatment of patients referred for transplants within the hospital's current service area and within the service area to which the hospital is requesting reassignment. In making the determination, HCFA considers: (1) cost effectiveness; (2) improvements in quality; (3) changes in a hospital's designated OPO due to changes in the metropolitan service area designations, if applicable; and (4) length and continuity of the hospital's relationship with an OPO other than the hospital's designated OPO.

If the hospital requests a waiver because HCFA has designated another OPO for the county in which the hospital is located, the hospital may continue to work with its current OPO until HCFA acts on the waiver request, as long as the hospital submits the waiver request within 30 days of notice of the change in designation. If the hospital requests a waiver for any other reason, the hospital must continue to work with its current OPO until HCFA acts on the waiver request.

Waiver requests should be submitted to:

All Usable Tissues

Q.20 The regulation requires hospitals to have an agreement with at least one tissue bank and at least one eye bank to "cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement." Will HCFA define "usable tissues" and include age criteria for donor suitability in the definition? If not, how will hospitals know whether their tissue banks are recovering all usable tissues?

A.20 HCFA does not regulate tissue banks or the retrieval, processing, preservation, storage, or distribution of tissues, and, therefore, will not define usable tissues. The regulation does not prescribe how hospitals, OPOs, and tissue banks ensure that all usable tissues are obtained. Rather, the regulation encourages hospitals, OPOs, and tissue banks to collaborate and use best practices to ensure that all usable tissues are obtained. Hospitals, in making decisions about which tissue bank to use, may consult several sources to determine current government and industry standards for usable tissues.

Food and Drug Administration (FDA) regulations require specific medical screening and infectious disease testing of tissue. (See 21 CFR 1270.1 through 1270.43.) However, like the HCFA regulations, the FDA regulations do not specifically define "usable tissues," nor do they include age criteria. Individuals with questions about the FDA regulations may contact Paula S. McKeever at 301-827-6344.

One source of information hospitals can consult for guidance on standards for usable tissues is the American Association of Tissue Banks (AATB). The AATB is a peer review organization that publishes standards to ensure that tissue banks meet acceptable technical and ethical norms. The AATB accredits more than 60 of the approximately 100 tissue banks operating in the United States. In order to become accredited, a tissue bank must be inspected and monitored by the AATB for compliance with all aspects of the AATB's standards and procedures, such as record keeping, quality control, donor selection criteria, patient history, and safety. Individuals with questions about AATB accreditation and standards may contact the AATB at 703-827-9582.

The AATB's age criteria for tissue donors are as follows:

Cardiovascular:Acceptable donors shall be within the range of newborn (minimum weight generally four pounds) to 60 years of age.

Musculoskeletal:The medical director of the tissue bank shall determine age limits for bone and soft tissue.

Skin:Potential donors shall be evaluated on an individual basis by chart review and visual assessment for size, current medical status, and skin condition.

Individual tissue banks have widely varying standards for what they regard as usable tissues. Although all tissue banks must meet FDA minimum standards for screening and testing for infectious disease, some tissue banks perform additional screening and testing beyond the FDA requirements. There is also wide variation in the age limits individual tissue banks have established for suitable donors. For example, the University of California at San Diego Tissue Bank accepts skin from donors up to age 75 and certain types of bone and soft tissues from donors up to age 55; other tissue banks accept tissues from donors only up to age 60, regardless of the type of tissue.

Following are the donor age criteria from the American Red Cross Tissue Services, as an example of the criteria established by another well-respected, nationwide tissue bank.

Relationships Between OPOs, Eye Banks, and Tissue Banks

Q23. Are OPOs permitted to charge tissue banks and eye banks a fee for referring potential donors to them?

A23. Yes. In fact, the HCFA Provider Reimbursement Manual (Part I, §2773.1) instructs OPOs to establish a charge for tissue and eye services unless the cost is so insignificant that a charge cannot reasonably be determined. In response to requests from tissue banks and eye banks, we are considering whether to set up guidelines for OPOs to use in establishing a fair charge for referrals of potential tissue and eye donors. (Revised 9/99.)

Q24. Is it possible for tissue banks and eye banks to limit the number of referrals they receive from the OPO, rather than receiving a call about every death or receiving calls that have been screened using criteria established by the OPO?

A24. Yes. The regulation states that the OPO "determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose." (Emphasis added.) For example, if an eye bank wants to be notified only about the deaths of individuals under the age of 55 who do not test positive for HIV, the notification protocol should specify that. (Revised 9/99.)

Designated Requestors

Q25. Which entity has the authority to decide who initiates the request for donation to the family of a potential donor -- the OPO or the hospital? May OPOs require hospitals to track their consent rates or agree to provide total 24-hour coverage as a condition of using designated requestors in lieu of or in addition to organ procurement representatives?

A25. It has come to our attention that some OPOs have informed their hospitals that only organ procurement representatives may discuss donation with or request donation from families of potential donors or that hospitals may use designated requestors only if the hospital meets certain conditions specified by the OPO, such as providing 24-hour coverage. This is incorrect.

The regulation requires collaboration between the OPO and the hospital to ensure "that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate." Ideally, the OPO and hospital will decide together how and by whom the family will be approached. If possible, the OPO representative and a designated requestor (such as someone from the hospital staff who has established a rapport with the family) should approach the family together. Research has shown that the highest consent rates occur when the OPO and hospital staff approach the family together. However, in the event that collaboration is not possible, the hospital decides who approaches the family to provide information, discuss the family's options, and request donation. The hospital may choose to have an organ procurement coordinator from the OPO approach the family or may choose to have a "designated requestor" approach the family.

Q26. Are tissue banks and eye banks required to have their training for tissue and eye requestors approved by the OPO before their tissue and eye requestors can become "designated requestors."? Does the regulation require tissue and eye bank representatives to take training offered by the OPO in order to request tissue and eye donation from families of potential tissue and/or eye donors who are not potential organ donors?

A26. There has been some confusion about the regulation's requirement for training of designated requestors. As stated in the preamble to the regulation, the requirement is based on research that shows that families of potential organ donors are more likely to consent to donation when best practices are used to initiate the request for donation. Therefore, the regulation requires that the individual who initiates the request must be an organ procurement representative or a designated requestor, i.e., an individual who has been trained in best practices for obtaining consent for donation.

Therefore, individuals such as physicians, nurses, clergy, tissue bank representatives, and eye bank representatives who initiate a request for organ donation must be trained in the consent process for organ donation. Individuals such as physicians, nurses, or clergy who initiate a request for tissue and eye donation must be trained in the consent process for tissue and eye donation. However, we assume that tissue and eye bank representatives already have been trained in the consent process for tissue and eye donation just as we assume that organ procurement representatives have been trained in the consent process for organ donation.

HCFA does not regulate issue banks or eye banks and has no authority over the training that tissue bank and eye bank representatives receive. The regulation does not require tissue and eye bank representatives to take training offered or approved by the OPO in order to request tissues or eyes. However, if a hospital believes a tissue bank or eye bank requestor has not been properly trained, the hospital can refuse to allow the tissue bank or eye bank requestor to talk to families of potential tissue or eye donors until such training takes place.

A tissue bank or eye bank representative would need to take training offered or approved by the OPO and become a "designated requestor" only if he or she were to request organ donation or if he or she were to request tissue or eye donation from the family of a potential organ donor before the OPO representative or a designated organ requestor had the opportunity to discuss organ donation with the family.However, the latter circumstance is unlikely. The preamble to the regulation clearly states that families of potential donors should be approached by only one agency, so that the family of a potential organ, tissue, and eye donor is not approached separately by the OPO, the tissue bank, and the eye bank. Nevertheless, a tissue bank or eye bank representative who is not a designated requestor but who needs to discuss tissue or eye donation with the family of a potential organ donor must wait until the organ procurement representative or designated organ requestor has either obtained or been refused consent for organ donation.

The specific requirement that the training offered to designated requestors be "offered or approved by the OPO and designed in conjunction with the tissue and eye bank community" was included to encourage OPOs, tissue banks, and eye banks to collaborate in designing a course so that individuals such as physicians, nurses, and clergy who want to become designated requestors for organ, tissue, and eye donation can take a single course, rather than two or even three separate courses. If an OPO plans to offer training in tissue and eye donation as well as organ donation, they must include the tissue and eye banks in their service area in developing the training material and training designated requestors. (Revised 9/99.)

Q27. Does the regulation require that anyone who discusses donation with the family of a potential organ donor must be a designated requestor, even if that person does not actually "initiate the request?"

A27. The process of requesting donation from the family of a potential donor includes providing information to the family about donation and their donation options and making an actual request for donation. Since these two parts of the process are inextricably linked, the phrase "initiate the request" in the regulation describes the entire process. Therefore, any individual who provides information to the family about donation, informs the family of its donation options, or makes the request for donation must be either an organ procurement representative or a designated requestor. The individual must be a trained designated requestor even if the individual is acting in a supportive or collaborative role with the OPO in performing any of these functions. As stated in the answer to the previous question, whenever possible, part of this process or the entire process should be performed by the OPO and a designated requestor from the hospital together. (Revised 9/99.)

Q28. Does the requirement for designated requestor training mean that individuals who have not received the training are not permitted to answer questions about donation?

A28. No. The requirement for designated requestor training should not be construed as a "gag order" for hospital staff who have not received training. Hospital staff and others, such as chaplains, are not forbidden to answer questions about organ donation if they have not received designated requestor training. The key to whether designated requestor training is required lies in whether the individual "initiates the request" to the family. As explained in the answer to the previous question, initiating the request includes mentioning donation to the family of a potential donor, providing information about donation to the family, informing the family about their donation options, or making the actual request for donation.

Although it is important for other hospital staff to receive some training about donation issues, it is not necessary for every individual to be a trained designated requestor merely to answer a question about donation. For example, an attending physician whose patient asks a question about donation during a hospital stay would not need to be a designated requestor to answer the question. (Revised 9/99.)

Q29. What type of training should OPOs be offering for designated requestors? For example, how long should the training last and what should be covered?

A29. The goal of designated requestor training is to train individuals in best practices for requesting organ donation, so that hospital staff and other individuals who initiate a request for donation to the family of a potential donor will do so both with respect for the family's circumstances, views, and beliefs and in a manner that is most likely to lead to the family's willing consent to donation. It is apparent that there is a wide disparity in the types of training OPOs are planning to offer. We believe that some uniformity is necessary to ensure that the training produces competent, successful designated requestors. Therefore, we are providing a list of elements for OPOs to utilize in designing their training.

The following list was developed in conjunction with organizations and agencies experienced in this type of training -- the North American Transplant Coordinators Organization, the Partnership for Organ Donation, Verble and Worth, the National Kidney Foundation, and the Health Resources and Services Administration (HRSA). HRSA, in collaboration with the organ donation community, will be studying training programs and making recommendations for future training.

Confidentiality Issues

Q41. Is a hospital violating confidentiality by calling the OPO and providing information about an individual who has died or whose death is imminent? Should the family be informed that the hospital must contact the OPO before the OPO is notified about the death? (Revised 9/99.)

A41. No. The Federal statute and implementing regulation require the hospital to call the OPO to provide timely notification of all deaths or imminent deaths that occur in the hospital. Although the statute and regulations are not explicit in establishing that such notification does not violate patient confidentiality, it is implicit in the law. A major goal of the hospital and OPO conditions of participation is to increase organ donation. It is implicit that this can only be accomplished by the exchange of information between hospitals and OPOs about potential donors so that medical suitability can be determined. Otherwise, the law would be ineffective. Additionally, there is no requirement in the statute or regulations that the family is informed about the hospital's notification of the OPO before the OPO can be contacted.

However, both the hospital and OPO regulations require that hospitals and OPOs have procedures for ensuring the confidentiality of patient records and information. See 42 C.F.R. § 482.24(b)(3) and 42 C.F.R. § 486.306(o). Therefore although patient records and information are exchanged between the hospitals and OPOs to facilitate and increase organ donation, they must ensure the information remains confidential and is not accessed by unauthorized individuals. The term "unauthorized individuals" has not been specifically defined in the regulation, but it is implicit that such individuals are those who are not directly involved as employees of the hospital or OPO in facilitating organ donation or transplantation.

Q42. Is it a violation of confidentiality for a hospital to permit the OPO to review patient death records?

A42. No. The Federal statute and implementing regulation require the hospital to work cooperatively with OPOs, tissue, and eye banks in performing death record reviews. Although the regulation is not explicit in establishing that death record reviews do not violate patient confidentiality, it is implicit in the law. The goal of the hospital and OPO conditions of participation is to increase organ donation. It is implicit that this can be accomplished by the exchange of information between hospitals and OPOs, through death record review, to facilitate and/or increase organ donation.

However, both the hospital and OPO regulations require that hospitals and OPOs have procedures for ensuring the confidentiality of patient records and information. See 42 C.F.R. § 482.24(b)(3) and 42 C.F.R. § 486.306(o). Therefore although patient records and information are exchanged between the hospitals and OPOs to facilitate and increase organ donation, they must ensure the information remains confidential and is not accessed by unauthorized individuals. The term "unauthorized individuals" has not been specifically defined in the regulation, but it is implicit that such individuals are those who are not directly involved as employees of the hospital or OPO in facilitating organ donation or transplantation.

Hospital Records

Q43. Is a hospital "cooperating" with an OPO in death record reviews if the hospital performs the death record reviews and shares the information with the OPO but does not permit the OPO access to the death records?

A43. No. The regulation requires a hospital to "work cooperatively" with the OPO in reviewing death records. OPOs and hospitals should work together to include death record reviews in their internal quality improvement processes.

Q44. Is a hospital required to permit the OPO to review death records of individuals who died prior to the date the regulation became effective, August 21, 1998?

A44. No. The regulation applies only to deaths that occur on or after August 21, 1998. However, there is nothing in the regulation that precludes review of death records for deaths that occurred prior to the effective date of the regulation. Most OPOs, tissue banks, and eye banks have been performing death record reviews in hospitals in their service areas for years. (Revised 9/99.)

Q45. Will results from an OPO's review of hospital death records be used by HCFA to monitor hospital compliance with the regulation?

A45. No. Compliance monitoring is the responsibility of HCFA, the State survey agencies with which it contracts, and the two organizations that have been given deeming authority by HCFA for hospital accreditation (the Joint Commission for Accreditation of Healthcare Organizations and the American Osteopathic Association). OPOs and hospitals should include death record reviews as part of their internal quality improvement processes.

Q.46 Are there specific records hospitals will need to keep to show a surveyor that the hospital has notified the OPO about a death?

A.46 Not at the present time. Some OPOs are providing their hospitals with a form hospital staff can fill out and include with the patient's medical record. Alternatively, hospitals may devise their own form or simply annotate the patient's medical record. However, we would suggest that the hospital include information the OPO and hospital will need for quality improvement, e.g., the name of the individual who requested consent.

Q47. If an OPO performs hospital death record reviews, is the OPO required to share the results of those reviews with the tissue bank and eye bank with which the hospital has agreements?

A47. Although there is nothing in the OPO conditions of coverage that requires OPOs to share the results of their death record reviews with tissue banks and eye banks, generally OPOs are willing to do so. However, this information is of somewhat limited value to tissue banks and eye banks, because OPOs' death record reviews focus on missed opportunities for organ (but not tissue or eye) donation. However, the regulation requires hospitals to work cooperatively with tissue banks and eye banks, as well as OPOs, in reviewing death records to improve identification of potential donors. Therefore, hospitals are encouraged to give their tissue banks and eye banks access to death records so that they can perform their own reviews. (Revised 9/99.)

Q48. A State hospital association has instructed their member hospitals to forward unsigned orders for the donor to the OPO medical director for his signature. Do HCFA regulations permit the OPO medical director to sign such orders?

A48. A hospital is required under the hospital conditions of participation at 42 CFR 482.24(c)(1) to assure that all entries into the medical record (including orders) are legible, complete and authenticated and dated by the person responsible for ordering, providing, or evaluating the service furnished. The fact that the patient has died does not negate this requirement. Therefore, the orders should not be signed by the OPO's medical director but by the responsible physician in the hospital. (Revised 9/99.)

Consent Process

Q.49 If the attending physician of a potential donor believes that the family of the donor is too grief stricken to be approached about donation, has religious beliefs that would preclude donation, or would react in a hostile manner to the idea of donation, is it permissible for the physician to decide that the family should not be approached by anyone about donation?

A.49 No. The preamble to the regulation states, "The hospital staff's perception that a family's grief, race ethnicity, religion, or socioeconomic background would prove a barrier to donation should never be used as a reason not to approach the family. We cannot emphasize too strongly that all families of potential donors must be advised about their donation options." If the attending physician or other hospital staff have concerns about how the family of a potential donor will react to being approached about donation, they should share their concerns with OPO staff and collaborate with them in devising a way to ensure that family members are advised of their right to donate, while at the same time respecting the family's individual circumstances and beliefs.

Q50. If the family of a potential donor raises the subject of donation and informs hospital staff they do not want to donate their loved one's organs, tissues, or eyes, is it still necessary for an OPO representative or designated requestor to talk to the family to ensure the family "is informed of its options to donate organs, tissues, or eyes, or to decline to donate" as the regulation requires?

A50. Yes. A family may indicate an unwillingness to donate for many reasons. For example, the family may not understand brain death or they may feel angry because they do not believe every effort was made to save their loved one. An OPO, tissue bank, or eye bank representative or designated requestor is trained to help families of potential donors understand issues such as brain death. They can also serve as counselors and can help families begin to come to terms with their anger or grief. It is possible that if a representative or designated requestor talks to the family, the family will decide to donate. Even if the family declines to donate, the discussion may serve as the first step in helping the family deal with their loss.

Maintaining Potential Donors

Q51. Once the family of a hospital patient has decided upon a "do not resuscitate" (DNR) order, some hospitals discontinue fluids because they believe that giving fluids is counter to the intent of a DNR order. However, if the family subsequently decides to donate, organs may already have been lost because dehydration has developed. Is there anything in the regulation that requires hospitals to continue to hydrate these patients?

A51. The regulation requires hospitals to report "imminent deaths" to the OPO and to work cooperatively with the OPO, tissue bank, and eye bank to maintain potential donors while necessary testing and placement of potential organs, tissues, and eyes take place. HCFA does not define "imminent death," and the answer to Q.7 states that OPOs should work with their hospitals to develop a definition of "imminent death" and a referral protocol. Once the imminent death is reported, if the patient is identified by the OPO as a potential donor, the hospital is required to continue to maintain the patient so that the patient's organs remain viable. (Revised 9/99.)

Effect of the Regulation on State Laws

Q.52 If a State has routine referral legislation in effect, does the State law take precedence? For example, New York State law permits OPOs to exclude certain age or clinical categories of deaths from referral. Are hospitals in New York required to refer all deaths, or may they use exclusionary criteria developed by their OPO?

A.52 The Federal regulation supersedes both State laws and State regulations unless the Federal regulation presents irreconcilable conflicts with State policies. In a State that permits OPOs and hospitals to exclude certain categories of deaths from referral, the Federal regulation takes precedence, and hospitals in that State must refer all deaths to their OPO.

Q53. The regulation requires hospitals to ensure that families of potential donors are informed about their donation options "in collaboration with the designated OPO." However, the regulation stops short of requiring that hospitals allow OPOs access to families to discuss donation. In fact, the answer to Q15 states that if collaboration is not possible, the hospital decides who approaches the family.

In contrast, some States have laws that require that hospitals allow OPOs to talk to families of potential donors. In these States, does State law supersede the Federal regulation?

A53. We strongly urge hospitals to make their OPOs partners in the process of informing families about their donation options. Research has demonstrated clearly that when OPOs and hospitals collaborate in discussing donation with families of potential donors, consent rates are the highest. Consent rates are nearly as high when OPO representatives discuss donation without hospital collaboration and considerably lower when hospital staff discuss donation without OPO collaboration. However, in States with laws requiring hospitals to permit the OPO to request consent from the families of potential donors, the Federal regulation prevails, and the hospital may choose to have either an OPO representative or a designated requestor initiate the request to the family. (Revised 9/99.)