Medicare and Medicaid Programs; Hospital Conditions of Participation; Identification of Potential Organ, Tissue, and Eye Donors and Transplant Hospitals' Provision of Transplant-Related Data

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 482

[HCFA-3005-F]

RIN: 0938-AI95

Medicare and Medicaid Programs; Hospital Conditions of

Participation; Identification of Potential Organ, Tissue, and Eye

Donors and Transplant Hospitals' Provision of Transplant-Related Data

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule.

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SUMMARY: This final rule addresses only provisions relating to organ

donation and transplantation. It imposes several requirements a

hospital must meet that are designed to increase organ donation. One of

these requirements is that a hospital must have an agreement with the

Organ Procurement Organization (OPO) designated by the Secretary, under

which the hospital will contact the OPO in a timely manner about

individuals who die or whose death is imminent in the hospital. The OPO

will then determine the individual's medical suitability for donation.

As well, the hospital must 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 long as the agreement does not interfere with organ donation.

The final rule requires a hospital to ensure, in collaboration with the

OPO with which it has an agreement, that the family of every potential

donor is informed of its option to donate organs or tissues or not to

donate. Under the final rule, hospitals must work with the OPO and at

least one tissue bank and one eye bank in educating staff on donation

issues, reviewing death records to improve identification of potential

donors, and maintaining potential donors while necessary testing and

placement of organs and tissues take place. In addition, transplant

hospitals must provide organ-transplant-related data, as requested by

the OPTN, the Scientific Registry, and the OPOs. The hospital must also

provide, if requested, such data directly to the Department.

DATES: These regulations are effective on August 21, 1998.

FOR FURTHER INFORMATION CONTACT: Marcia Newton, (410) 786-5265.

SUPPLEMENTARY INFORMATION:Copies: To order copies of the Federal

Register containing this document, send your request to: New Orders,

Superintendent of Documents, P.O. Box 37194, Pittsburgh, PA 15250-7954.

Specify the date of the issue requested and enclose a check or money

order payable to the Superintendent of Documents, or enclose your Visa

or Master Card number and expiration date. Credit card orders can also

be placed by calling the order desk at (202) 512-1800 or by faxing to

(202) 512-2250. The cost for each copy is $8. As an alternative, you

can view and photocopy the Federal Register document at most libraries

designated as Federal Deposit Libraries and at many other public and

academic libraries throughout the country that receive the Federal

Register.

I. Background

A. Key Statutory Provisions

Sections 1861(e) (1) through (8) of the Social Security Act (the

Act) provide that a hospital participating in the Medicare program must

meet certain specified requirements. Section 1861(e)(9) of the Act

specifies that a hospital must also meet such other requirements as the

Secretary finds necessary in the interest of the health and safety of

the hospital's patients.

[[Page 33857]]

Under this authority, the Secretary has established in regulations the

requirements that a hospital must meet to participate in Medicare (42

CFR Part 482, Conditions of Participation for Hospitals).

Section 1905(a) of the Act provides that Medicaid payments must be

applied to hospital services. Under regulations at 42 CFR

440.10(a)(3)(iii), hospitals generally are required to meet the

Medicare Conditions of Participation in order to participate in

Medicaid.

Section 1138 of the Act provides that a hospital participating in

Medicare must establish written protocols for the identification of

potential organ donors that (1) ensure that families of potential organ

donors are made aware of the option of organ or tissue donation and

their option to decline donation, (2) encourage discretion and

sensitivity with respect to the circumstances, views, and beliefs of

those families, and (3) require that an organ procurement agency

designated by the Secretary be notified of potential organ donors.

B. Why the Hospital/OPO Relationship Must Improve

An estimated 12,000 to 15,000 deaths occurring in the United States

every year could yield suitable donor organs. [Gortmaker SL, Beasley

CL, et al. ``Organ donor potential and performance: Size and nature of

the organ donor shortfall.'' Critical Care Medicine (1996); 24 432-39]

However, in 1997, only 5,475 of these deaths resulted in the donation

of an organ.

As progress has been made in the science of transplantation, the

gap has widened considerably between the number of individuals who

could benefit from transplants and the number of organs available for

transplantation. In the twelve years since the enactment of Section

1138 of the Act, the number of organ donors has increased by only 33

percent, while the transplant waiting list has grown by 250 percent. As

of June 3, 1998, 56,222 individuals were on the waiting list for a

transplant, but the number of organs transplanted from cadaveric donors

in 1997 numbered only 17,032. Preliminary 1997 data compiled by the

Organ Procurement and Transplantation Network contractor indicates that

the number of donors (5,475 donors in 1997) increased by only 54 donors

or by less than one percent over the 5,421 donors in 1996.

A 1993 Gallup poll showed that 85 percent of Americans support the

general concept of organ donation and 69 percent would be somewhat or

very likely to donate their own organs. [The Gallup Organization, Inc.

``The American Public's Attitudes Toward Organ Donation and

Transplantation,'' A survey prepared by the Gallup Organization, Inc.

for The Partnership for Organ Donation, Boston, Massachusetts,

(February 1993)] Information from a number of recent studies and from

States that have passed organ donor legislation has given us a clearer

understanding of the reasons for the disparity between the strong

public support for the concept of organ donation and the apparent

failure of the current system to convert potential donors to actual

donors. We have used this information to guide us in promulgating the

final rule.

II. Notice of Proposed Rulemaking

On December 19, 1997, a proposed rule, ``Medicare and Medicaid

Programs; Hospital Conditions of Participation; Provider Agreements and

Supplier Approval'' [HCFA-3745-P] was published in the Federal Register

[62 FR 66726]. The proposed rule extensively revised the current

conditions of participation for hospitals. Among the proposed changes

were provisions designed to increase the number of organs available for

transplantation.

The proposed rule was developed in response to issues raised during

public hearings held by the Department on December 11 through 13, 1996,

to examine the allocation policies for liver transplantation and to

receive comments regarding methods to increase organ donation. The

comments we received at the public hearings highlighted that there is a

critical shortage of organs available for transplantation and some of

the options available to alleviate the shortage.

Every day an estimated 10 individuals in the United States die

because organs are not available to save their lives. This fact gave

particular urgency to publication of a final rule covering the

provisions of the proposed rule designed to increase donation and

transplantation. Therefore, we have extracted those provisions from the

proposed rule and are publishing them here, with some modifications, as

a final rule. We will be publishing other provisions of the proposed

rule as a final rule at a later date.

III. Analysis of and Responses to Public Comments

We received a total of 150 comments on these provisions from

hospitals, OPOs, tissue and eye banks, professional organizations,

transplant organizations, medical practitioners, donor family

organizations, and other organizations and individuals. A summary of

the major issues and our responses follow:

Impact on Tissue and Eye Donation

Comment: Several commenters said the regulation should not require

that hospitals contact OPOs exclusively about potential donors,

including potential tissue and eye donors. Commenters voiced concern

that calls about potential tissue donors would not be handled by the

OPOs satisfactorily.

Response: The proposed rule did not include a requirement that all

calls be referred exclusively to an OPO. However, the final rule does

include a requirement that all deaths must be referred to the OPO or a

third party designated by the OPO, using protocols developed by the

OPO. In the absence of separate arrangements between the hospital and a

tissue bank and an eye bank, the OPO will identify and refer potential

tissue and eye donors using protocols developed in consultation with

the tissue bank and eye bank. The final rule also authorizes a hospital

to notify a tissue or eye bank directly about potential tissue or eye

donors. We believe these requirements will assure that the interests of

the tissue and eye banks are considered and will encourage all parties

to reach a consensus that will honor the hospital's need for a referral

process that is not burdensome for hospital staff.

Comment: One commenter stated that the proposed rule does not

address ways to effectively ensure OPO and hospital cooperation with

the eye and tissue banks in their communities. Many commenters

questioned why the OPOs should be the ``gatekeepers'' for all donations

and predicted this would adversely impact tissue and eye donations. One

commenter suggested all language referring to tissues or eyes be

removed from the text of the regulation, so that the rule applies only

to organ donation. The commenter expressed the belief that expecting

OPOs to serve as the focal point for both organ and tissue donation

places too great a burden on OPOs.

Response: In promulgating a rule designed to increase organ

donation, we wish to avoid the possibility that the rule will have an

adverse impact on tissue and eye donation and retrieval. In the

proposed rule, we stated our expectation that hospitals, OPOs, eye and

tissue banks would work cooperatively and effectively to facilitate and

enhance organ, tissue, and eye donation. However, we noted the

considerable local variation in arrangements and how they might be

modified under the proposed changes. We specifically requested comments

on

[[Page 33858]]

how the proposed rule might impact tissue donation and suggestions for

measures we can take to maximize donation of organs, tissues, and eyes.

We received many comments from tissue and eye banks, their

professional organizations, and individuals active in this area. Some

of these commenters stated that in communities where the relationship

among the hospitals, OPOs, and the tissue and eye banks is

collaborative in nature, the system works well. Many described

communities where a single, toll-free telephone number has been

established for hospitals to call for referrals of potential organ,

tissue, and eye donors. The entity taking the call (whether the OPO or,

in some cases, a commercial entity under contract) screens the calls

and refers them appropriately and expeditiously. However, other

commenters described communities where some hospitals have never

referred a single potential donor and where the relationship between

the OPO and the tissue and eye banks is acrimonious and antagonistic.

The final rule preserves the flexibility of hospitals, tissue

banks, and eye banks to enter into arrangements that do not involve the

OPO. However, the final rule makes OPOs the default ``gatekeepers'' for

referral of potential tissue and eye donors in the absence of other

arrangements. Therefore, we have included in the final rule a

requirement that the OPO consult with the tissue and eye bank(s) in

establishing protocols for the identification and referral of potential

tissue and eye donors. We have also added language to ensure that

hospitals work cooperatively with a tissue bank and an eye bank, as

well as the OPO, in educating hospital staff, reviewing death records,

and maintaining potential donors. We will be monitoring the progress of

the cooperative relationships envisioned by this rule to ensure that

the gatekeeper role described does not harm tissue and eye donation.

Comment: Many commenters suggested expanding the regulation so that

tissues and eyes are included. One commenter pointed out that there is

a critical shortage of tissues for transplant in the United States. For

example, patients who await a long bone allograft for treatment of

cancer must often wait months for a transplant or resort to amputation.

Several commenters said that only 8 percent of needed tissue is

currently obtained. Other commenters added that we should include in

the final regulation definitions for tissues and eyes.

Response: We agree there is a critical need for tissues and corneas

as well as solid organs. We have, therefore, modified the text of this

regulation to ensure that tissue and eye banks participate in the local

decision-making process. We believe that the addition of these

references will increase donations for tissues and eyes as well as

solid organs. The procurement and transplantation of tissues and eyes,

however, is not regulated by HCFA; therefore, we are not including

definitions of these terms in the final rule. The regulation requires

OPOs to consult with the designated tissue and eye bank in defining

tissue and eye donor and we will rely upon the OPOs, tissue banks, and

eye banks to define tissues and eyes as well.

Comment: Some commenters suggested that the rule discourage

excessive fees charged by OPOs for referral of tissue donations to

tissue and eye banks. Some commenters said that some OPOs may begin

referring their donor calls to the highest cost reimburser, with eye

and tissue banks forced to try to outbid each other for tissues. One

commenter was concerned about donor family and public perceptions that

might negatively affect willingness to donate. Other commenters

expressed concern that high referral fees would put eye banks out of

business.

Response: Our policies defining reimbursement for OPOs extend only

to those activities in which the OPO engages on behalf of an eligible

Medicare or Medicaid beneficiary, and are limited to reasonable costs.

Therefore, any expenses incurred by an OPO, or any charges which may be

made to payers other than HCFA, will not be addressed here. We have,

however, expressly preserved hospitals' rights to enter into agreements

with tissue and eye banks so long as those arrangements do not

interfere with an OPO's efforts to recover solid organs. We would

anticipate that tissue and eye banks that encounter fees they consider

excessive would have the opportunity to address this issue during the

establishment of donor and referral protocols.

Comment: One commenter stated we should clarify that our intent is

not to disrupt existing contracts between hospitals and tissue banks.

Response: It is certainly not our intent to disrupt contracts

between hospitals and tissue banks or hospitals and eye banks. We

believe the regulation's requirement which authorizes agreements

between the hospital and a tissue bank and an eye bank and its emphasis

on collaboration among hospitals, OPOs, and tissue and eye banks will

increase tissue and eye donation without disrupting contracts.

Referral Systems

Comment: Some commenters expressed concern that the proposed rule

would mean elimination of current, successful community systems for

referral of organ, tissue, and eye donors.

Response: Our intent in promulgating this rule is certainly not to

disturb successful community referral systems, and we would urge

hospitals and OPOs not to abandon them. Therefore, we have revised the

rule to clarify that it does not preclude such systems. The final rule

permits the hospital to refer potential donors to a third party

designated by the OPO and to continue successful arrangements with

tissue banks and eye banks. In addition, we encourage OPOs and

hospitals, in consultation with tissue and eye banks, to use this

opportunity to improve upon current referral systems to maximize not

only organ donation but tissue and eye donation as well.

Comment: Many commenters suggested a system whereby all referral

calls go to a single non-proprietary answering service or a referral

system operated by one of the organ or tissue agencies and supported by

all. They pointed out that the process is more successful when

hospitals are required to make a single phone call, rather than

contacting multiple agencies about a potential donor. One commenter

added that hospitals and grieving families should not be burdened with

two distinct but parallel operating communications regarding donations.

One large, nationwide tissue bank suggested that all referrals be made

either to the OPO or a non-proprietary service. One eye bank commented

that eye banks in areas with a non-proprietary phone number experience

an increase in donations. In contrast, another tissue bank suggested a

two-call system which is used in its State. In this State, hospitals

are required to contact the OPO on all brain deaths. All other deaths

are reported to a referral agency, based on a plan agreed to by the

hospital and all other agencies.

Response: Before responding to the comment, we want to clarify that

this rule requires hospitals to notify OPOs or a third party designated

by the OPO, of individuals whose death is imminent of who have died in

the hospital. Some commenters make reference to ``brain death'' donors,

meaning heart beating donors who have been declared brain dead. This

regulation does not exclude the reporting of non-heartbeating deaths.

Hospitals must report both brain dead and cadaveric potential donors.

[[Page 33859]]

We have added language to the text of the regulation to clarify that

referral of phone calls to a third party entity designated by the OPO

is not precluded. Anecdotal evidence indicates that a one-phone-call

referral process may increase organ donations, as well as tissue and

eye donations. Logically, it would seem that a system that makes it

possible for a hospital to refer potential donors with a single phone

call would make hospital compliance easier and, therefore, more likely.

We would urge communities to explore this option.

However, regardless of how the referral by the hospital is

accomplished, we would also urge that protocols ensure that families of

potential donors are approached about donation by a single agency

(either the OPO, a tissue bank, or an eye bank) in collaboration with

hospital staff. For example, Florida donation legislation provides that

the OPO must be given the opportunity to approach the families of

suitable vascular organ donors. OPOs may represent the tissue and eye

bank. Under the Florida law, the tissue bank must be given the

opportunity to approach the family of suitable tissue donors if the OPO

has not already approached the family. Eye banks must be given the

opportunity to approach the family of suitable eye donors if the OPO or

a tissue bank has not already approached the family.

Comment: Several commenters suggested we strengthen the regulation

by adopting a routine referral approach which requires referral of all

patient deaths to OPOs. Commenters pointed to the success of the

Pennsylvania routine referral law and predicted similar increases in

donation rates if a nationwide routine referral approach were to be

adopted. Commenters gave the following reasons for supporting routine

referral: (1) A clear standard is established for hospitals regarding

when referrals must be made to the OPO; (2) allows early intervention

by the OPO to guide the organ and tissue process to ensure a successful

outcome; (3) ensures that the hospital will not erroneously assume that

a potential donor is too old or has a medical condition that precludes

donation; (4) removes from hospitals the burden of keeping abreast of

changing standards for donor screening and suitability criteria; (5)

minimizes regional differences in organ procurement and transplant

waiting times, and (6) facilitates compliance by hospital systems whose

member hospitals are served by more than one OPO. However, many

commenters who supported routine referral suggested some flexibility be

built into the regulation in consideration of resource limitations or

local circumstances. For example, commenters suggested that deaths of

individuals above a certain age be excluded from routine referral.

Response: We agree with the commenters who support routine referral

of all deaths and have adopted their recommendation in this regulation.

We believe that the experiences of States with routine referral

legislation have demonstrated that referral of all deaths is the single

most critical factor in increasing organ donation rates. Referral of

all deaths assures that determination of medical suitability is made by

the OPOs, because OPOs are the entities with knowledge of transplant

hospitals' donor suitability criteria.

However, we have not adopted the recommendations of those who

advised us to give OPOs the discretion to exclude certain categories of

deaths from the requirement for routine referral. Referral of all

deaths, with no exclusions, eliminates the need for OPOs and hospitals

to rewrite referral protocols and reeducate hospital staff whenever

transplant hospitals' donor suitability criteria change. It is also

less difficult for HCFA to monitor hospital compliance if there are no

exclusions. Finally, it is important to note that many OPOs will be

screening donors for tissue and eye donation, and tissue and eye banks

often have criteria for donation that differ significantly from the

criteria for organ donation. For example, in 1997, only 6.4 percent of

organ donors were over the age of 65. The Eye Bank Association of

America reports however, that more than 28 percent of all eye donors in

1997 were over the age of 70.

Comment: Some commenters urged us not to adopt a routine referral

approach. Commenters stated that routine referral will not work where

relationships between OPOs and hospitals are, at best, uncooperative.

Other commenters cited the burden and cost to hospitals and OPOs of

making or receiving many unproductive calls.

Response: We believe routine referral is workable and will increase

organ donation. We hope that all OPOs and hospitals will be encouraged

by this regulation to develop relationships that increase organ and

tissue donation. If they are not able to develop such relationships,

however, a hospital may choose to seek waiver to associate with another

OPO, or the original OPO may find itself unable to meet HCFA

certification standards and be replaced by an OPO better able to

develop the kind of relationships that lead to greater organ and tissue

recovery.

A 1988 commentary published in the Journal of the American Medical

Association states that the cooperation of the medical professions is

the primary factor limiting the supply of transplantable organs. The

author suggests that routine referral ``would not solve all the

problems of professional cooperation, but it would ameliorate a key one

and open the bottleneck that presently constrains the supply of

organs.'' [Prottas, J. ``Shifting Responsibilities in Organ

Procurement: A Plan for Routine Referral.'' Journal of the American

Medical Association. 1988;260:6]

We do not expect the cost to hospitals of referring all deaths to

be significant. As discussed in the Regulatory Impact Statement, the

average hospital should require no more than four person days per year

to report every death that occurs in the hospital to the OPO. This time

is in lieu of time hospitals' spend complying with existing

requirements. If tissue and eye referrals are made by the hospital to

either the OPO or a third party entity, rather than to tissue and eye

banks, calls made to tissue and eye banks about medically unsuitable

donors should not increase, as the calls will be screened by the OPO or

third party entity. However, we expect that OPOs will find that the

increased number of donations resulting from routine referral will

enable them to meet the additional expenses without a significant

increase to their current standard organ acquisition costs. Further

information about the expected economic impact of routine referral on

OPOs can be found in the Regulatory Impact Analysis.

Best Practices

Comment: Some commenters suggested that HCFA is abdicating its

policy-making and regulatory authority to the OPOs. The commenters

urged us to identify the best practices by which organ donation can be

increased and use those practices as the basis for a regulatory

definition of potential donor. The commenters pointed out that the

proposed rule indicates that approximately 12,000 to 15,000 of the one

million patients who die in hospitals annually are likely to be

potential organ donors but that the proposed rule does not establish

criteria by which hospitals would be required to identify those

patients.

Response: We have not specifically defined potential donor in the

final rule because the definition is continually changing, particularly

as to the upper age. Instead, we have included the requirement that

hospitals routinely refer all deaths and all individuals for

[[Page 33860]]

whom death is imminent to the OPO, with the assumption that this

requirement will, in most communities, lead to better identification of

the medical suitability of the potential donor based on the most recent

medical research in transplantation. Contrary to the commenter's

statement that one million patients die annually in hospitals, it is

estimated that there are approximately 2,080,000 hospital deaths per

year. The final rule also requires that the hospital and OPO

collaborate in advising the family of potential donors of their option

to donate. We have chosen not to dictate best practices for other

aspects of organ donation, such as education and death records review,

as we believe that each hospital and OPO, working together, can

identify practices that will be most useful in their specific

situation.

Following is a synopsis of the most recent research in organ

donation and best practices for organ donation. We encourage hospitals

and OPOs to use these studies and the many other studies that have been

done on best practices for organ donation to guide their development of

protocols that will work to increase organ donation in their

communities. The estimate of 12,000 to 15,000 potential organ donors

annually is based on the results of retrospective reviews of 1,990

medical records in 69 acute care hospitals in 4 geographic regions in

the United States and a stratified random sample of 89 hospitals in 3

of the same areas (33 of the same hospitals) in 1993. The study found

that only one third of the potential organ donors became organ donors.

By extrapolating the 1990 findings to the entire United States,

researchers postulated a pool of 13,700 medically suitable donors per

year. [Gortmaker SL, Beasley CL, et al. ``Organ donor potential and

performance: Size and nature of the organ donor shortfall,'' Critical

Care Medicine (1996); 24:432-39]

The study also showed that potential donors were correctly

identified 90 percent of the time, and families were advised of their

donation options only 71 percent of the time. The study's authors

concluded that prospective identification and requesting donation in

all suitable potential donor cases could lead to 1,800 additional

donors per year.

An earlier study based on 1988 and 1989 data estimated the pool of

potential organ donors to be between 6900 and 10,700 annually. [Evans

RW, Orians CE, Ascher NL. ``The Potential Supply of Organ Donors: An

Assessment of the Efficiency of Organ Procurement Efforts in the United

States,'' Journal of the American Medical Association (1992); 267:239-

246.] The study was based on a review of multiple cause of death data

from death certificates. The researchers excluded non-traumatic causes

of death and, therefore, may have underestimated the potential donor

pool by as much as 50 percent. However, the study demonstrated that

there are many more potential than actual donors. The study's authors

concluded that it may be possible to increase the number of actual

donors by 80 percent.

These studies and several other recent studies are defining the

best practices for increasing organ donation. As research continues in

the field of organ donation, best practices will continue to evolve.

Therefore, we are hesitant to use current best practices as the sole

basis for promulgating a regulation that cannot be changed quickly

enough to keep pace with the results of future research in the field of

organ donation. However, we firmly believe there has been sufficient

research upon which OPOs and hospitals can develop protocols that will

lead to a significant increase in organ donation rates.

Through this final rule and related activities in the National

Organ and Tissue Donation Initiative, we are encouraging hospitals and

OPOs to incorporate other best practices into protocols for increasing

donation rates. For example, recent studies have indicated that organ

donation rates can be increased using a variety of best practices

related to (1) advising families of potential donors of their rights

regarding donation; (2) medical record reviews for evaluating

performance and identifying opportunities for education; and (3)

education of hospital staff.

The study cited above [Gortmaker SL, Beasley CL, et al. ``Organ

donor potential and performance: Size and nature of the organ donor

shortfall,'' Critical Care Medicine (1996); 24:432-39] found that

approximately half of the families asked to donate a relative's organs

decline to give consent. Likewise, a stratified random sample of 23

acute-care general hospitals in two metropolitan areas found that only

46.5 percent of families of potential organ donors agreed to donate

organs, and 22 percent of those who agreed to donate placed conditions

on the donation. [Siminoff LA, Arnold RM, Caplan, AL, Virnig BA,

Seltzer DL. ``Public Policy Governing Organ and Tissue Procurement in

the United States.'' Annals of Internal Medicine. 1995; 123:10-17] The

study's authors concluded that ``problems with the ways in which

families are asked about donation rather than the failure of . . .

altruism, may account for the high refusal rate.''

An interview study of donor and nondonor families [DeJong W, Franz

HG. ``Requesting Organ Donation: An Interview Study of Donor and

Nondonor Families,'' American Journal of Critical Care (1998);7: 13-23]

identified the factors identified with consent for organ donation. The

study cites unpublished data [Gortmaker SL, Beasley CL, Sheehy E, et

al] that demonstrate a significant increase in the consent rate when

three elements are in place when the family is advised of its right to

consent to or to decline donation. First, family members must be given

time to understand and accept their relative's death before the

donation request is made. This means that the hospital staff's

notification of the family about the patient's death and the

explanation of brain death must be ``decoupled'' from the request for

donation. An earlier study of the consent process also found the timing

of the request to be critical. The study indicated a 60 percent consent

rate when the subject of organ donation was discussed with the family

before notification of death, a 68 percent consent rate when organ

donation was discussed simultaneously with notification of death, and a

78 percent consent rate when organ donation was discussed after

notification of death. [Cutler JA, et al. ``Increasing the Availability

of Cadaveric Organs for Transplantation: Maximizing the Consent Rate,''

Transplantation (1993); 56(1)225-28]

Second, consent rates are higher when the request is made by the

OPO in conjunction with the hospital staff. A retrospective review of

all medically suitable potential donors referred to a single OPO in a

one-year period found a 67 percent consent rate when the OPO

coordinator approached the family alone, a 9 percent consent rate when

the hospital staff approached the family alone, and a 75 percent

consent rate when the approach was made by the OPO coordinator and

hospital staff together. [Klieger J, Nelson K, Davis R, er al. Analysis

of Factors Influencing Organ Donation Consent Rates. Journal of

Transplant Coordination (1994); 4:132-34] A 1995 article [Dejong, W,

Drachman, et al. ``Options for Increasing Organ Donation: The Potential

Role of Financial Incentives, Standardized Hospital Procedures, and

Public Education to Promote Family Discussion,'' The Milbank Quarterly

(1995);73: 463-79] suggested that the donation option should first be

mentioned to the family by a hospital-based health professional, but

the

[[Page 33861]]

formal request should be made by the OPO coordinator.

The third critical element in the consent process is the setting in

which the request for donation is made to the family. The request

should be made in a quiet, private setting, such as a conference room

or family meeting room, rather than in a hallway or waiting room. When

all of these methods are used in conjunction, consent rates are 47

percent higher than when none of these methods is used.

The study's authors note that in general there is currently no

widely accepted protocol with regard to the process for requesting

donation. They suggest that hospitals' protocols should include (1)

communicating often and honestly with the family about the patient's

prognosis, (2) making sure the family understands brain death, (3)

decoupling the request for donation from the explanation of brain

death, (4) using a quiet, private setting for discussion of donation

options, and (5) defining clear roles and responsibilities for the

hospital staff and the OPO coordinator.

Another recent study [McNamara P, Franz HG, Fowler RA, et al.

``Medical Record Review as a Measure of the Effectiveness of Organ

Procurement Practices in the Hospital,'' Joint Commission Journal on

Quality Improvement (1997);23:321-33] makes several recommendations for

quality improvement initiatives based on medical records review. The

study's authors suggest that OPO staff provide feedback from medical

records review to key hospital staff concerning practice improvements.

They suggest hospitals use information from medical records review to

assess the hospitals' performance in the organ donation process,

identify areas where performance can be improved, and monitor the

effectiveness of the implemented changes. They also suggest that

medical records review should be conducted annually at large hospitals.

As referenced earlier, research in education of hospital critical

care staff [Evanisko MJ, Beasley, CL, Brigham, LE. ``Readiness of

Critical Care Physicians and Nurses to Handle Requests for Organ

Donation,'' American Journal of Critical Care (1998); 7:4-12] found

that training of critical care physicians and nurses in effective

procedures for requesting organ donation is significantly associated

with higher rates of organ donation. However, two thirds of critical

care staff reported no relevant training. A 1986 United Network for

Organ Sharing survey found a surprising lack of knowledge among the

transplant hospital staff regarding knowledge of organ donation and

transplantation. [Ettner BJ, Youngstein KP, Ames JE. ``Professional

Attitudes and Knowledge About Organ Donation and Organ

Transplantation,'' Dialysis and Transplantation, (1988); 17:72-76]

Eighteen percent of the respondents were physicians, and 68 percent

were nurses. Thirty-four percent of the respondents were unsure if

their hospital had written protocols for organ recovery, and nearly

half of the respondents answered no to the statement that the organ

donor protocols provided adequate guidelines and protection for the

donor and for hospital staff. The final rule ensures that only OPO

representatives or trained individuals will approach families to

explain their donation options and make the actual request for

donation.

Our review of these and other studies has convinced us that there

has been sufficient research upon which OPOs and hospitals can base

protocols that will take advantage of best practices for advising

families of their right to consent to or to decline donation, evaluate

hospital and OPO staff performance through medical records reviews, and

educate hospital staff.

Necessity for Change

Comment: Several commenters suggested that we make no change in the

hospital conditions of participation for organ procurement

responsibilities. They pointed out that the current regulations, which

allow hospitals to establish their own organ donation policies, often

result in good donation rates. They suggested that in lieu of a

regulation, HCFA continue to evaluate what works to increase donation

rates and encourage hospitals and others to make changes.

Response: The current hospital conditions of participation have not

produced the results which were anticipated. Therefore, in our response

to the previous comment, we outlined research studies that show several

approaches that work to increase donation rates. We believe that all

hospitals, including those that are currently successful, should

consider whether these approaches, in addition to routine referral,

could further increase organ donation. A study of 1,990 death records

from 69 hospitals in four geographic regions found a wide variation in

hospital performance with a hospital donation rate (i.e., actual donors

as a percentage of potential donors) ranging from 0 percent to 68

percent. Note that this was not a random sample of hospitals; the

hospitals tended to be larger institutions with either a history of

donor activity or suspected potential for donation. The average organ

donor potential in the hospitals was 13.3; average actual organ donors

were 4.3. [Sheehy E, Poretsky A, Gortmaker, SL. ``Relationship of

Hospital Characteristics to Organ Donation Performance,''

Transplantation Proceedings (1996); 28:139-141]

These data demonstrate that, some hospitals need more than

encouragement to meet the requirements of section 1138 of the Act,

which mandates that hospitals identify potential organ donors and

assure that families of organ donors are informed of their donation

options. In view of the critical and growing shortage of donated organs

in this country, we would be abdicating our responsibility as a Federal

agency if our only response to this crisis were merely to be

encouragement. We believe that a less burdensome approach for

hospitals, requiring only a phone call to the OPO, will be more

successful in providing opportunities for families to consider

donation. Therefore, we are not accepting this comment.

Comment: One commenter suggested a delay in publishing the final

rule until the Department can convene a workshop to come up with a

different proposal. The same commenter also suggested allowing

hospitals at least three years to develop an action plan to increase

donation rates.

Response: We believe the need to substantially increase organ

donation immediately outweighs any potential benefits from adopting the

commenter's suggestion. As noted above, 10 people die every day waiting

for an organ transplant. In addition, the Department sought public

comments on the issue of increasing organ donation as part of its

development of a related rule regarding the Organ Procurement and

Transplantation Network, including a three-day public hearing in

December 1996. It also conducted a conference in April 1998 to identify

methods to evaluate and identify successful mechanisms to increase

donating consent. In view of the every-widening gap between the number

of people waiting for organ transplants and the number of organs

available, further delay in passing a regulation to alleviate this

crisis is unacceptable.

Regulatory Flexibility

Comment: Many commenters warned against promulgating a final

regulation that is too prescriptive. They emphasized that what is

needed, above all, is flexibility to design protocols to meet needs of

local communities, rather than a ``one-size-fits-all'' regulation

[[Page 33862]]

which defines potential donor and the protocols for notification and

referral for the entire country. One commenter pointed out that such

flexibility allows for look-back data and new research to be

incorporated into hospitals' policies.

Response: We agree with these commenters and have used this

viewpoint to guide our development of the final rule. For example, it

allows the OPO to determine medical suitability in light of the most

recent transplantation research and the needs of transplant recipients,

surgeons, and hospitals. The final rule requires collaboration between

the hospital and the OPO in informing families of potential donors of

their donation options because the evidence is overwhelming that

involvement of the OPO in the consent process is critical. We believe

however, it is best for hospitals and OPOs to have the flexibility to

design a protocol for informing families that takes into account

circumstances in each community. Finally, the final rule allows

hospitals, OPOs, and tissue and eye banks the flexibility to adapt best

practices in the areas of death record reviews and education of

hospital staff to suit the circumstances in their local communities.

Medical Suitability

Comment: One commenter suggested there should be Federal baseline

criteria for defining potential donors, with HCFA setting minimum

standards, including tests, required for an individual to donate an

organ. Hospitals and OPOs could be more exacting, but could not fall

below the Federal standard. Another commenter called for a national

conference to determine the broadest possible definition based on

national need and the varying acceptance criteria of transplant

surgeons and institutions. For example, commenters suggested variously

that ``potential donor'' should be defined as a patient who is brain

dead and heart beating or any patient on a ventilator.

Response: We believe these commenters are seeking a Federal

definition for medically suitable donors, rather than a Federal

definition for potential donors. Generally, a definition for potential

donors is designed to cast a wide net by defining potential donors, for

example, as all hospital deaths or all patients on ventilators. By

making the pool of potential donors so large, OPOs ensure that no

medically suitable donors are missed. However, many, if not most, of

the potential donors in this large pool will not be medically suitable

to be actual donors.

We are reluctant to impose a Federal standard for medically

suitable donors. Some OPOs, for example, the Louisiana Organ

Procurement Agency, have experimented with expanded criteria for

determining medically suitable donors, with good results. However,

transplant hospitals vary in their willingness and ability to

transplant organs from potential donors with particular medical

conditions or from donors who are past a certain age. At one time, most

organ donors were age 45 or younger; now some transplant hospitals are

transplanting livers from 80-year-old donors. According to the Organ

Procurement and Transplantation Network contractor, the 33 percent

increase in cadaveric donors between 1988 and 1996 is primarily due to

the increase in donors ages 50 and over. Cadaveric donors age 50 and

over increased from 12 percent in 1988 of all cadaveric donors to 27

percent in 1996. [United Network for Organ Sharing 1997 Scientific

Registry and Organ Procurement and Transplantation Network Annual

Report] Some transplant hospitals will consider organs from donors with

any medical condition other than metastatic cancer or HIV; other

transplant hospitals are more restrictive.

It is likely that as transplantation research continues, the

ability of medical professionals to obtain and transplant organs from

patients once considered medically unsuitable will grow. Therefore,

since the definition of medically suitable donor will likely be

broadened in the future, we believe it would be inappropriate to impose

a regulatory definition.

Comment: One commenter stated that in order to determine if a

potential donor is medically suitable to be a donor, it may be

necessary for the OPO to examine the body, conduct tests, review

medical records, and obtain medical information from the family and

physician. The commenter said that hospitals have expressed concern

that this violates laws governing patient privacy and confidentiality

of medical records and asked us to emphasize that the authority to do

so is implicit in the law.

Response: We agree with the commenter that the OPO may examine the

body of the potential donor and his or her medical records and conduct

the tests, inquiries, and investigations that are necessary to

determine if the potential donor would be medically suitable to be a

donor. The Public Health Service Act section 371, 42 U.S.C. 274

specifies that OPOs must arrange for the acquisition and preservation

of donated organs and provide quality standards for the acquisition of

organs which are consistent with the standards adopted by the OPTN

under section 372(b)(2)(E), including arranging for testing with

respect to preventing the acquisition of organs that are infected with

the etiologic agent for acquired immune deficiency syndrome. Section

371 of the Act also specifies that OPOs must arrange for the

appropriate tissue typing of donated organs. Certainly, after receipt

of consent for donation from the potential donor's family, it would be

necessary for the OPO to examine the body of the potential donor,

conduct tests, review medical records, and obtain medical information

from the family and physician in order to accomplish the requirements

of section 371 of the Act. Therefore, after receipt of consent, we

believe the authority to conduct testing, review medical records, and

gather other medical information needed to determine the medical

suitability of the potential donor is implicit in the law.

OPO Conditions of Coverage

Comment: Some commenters had suggestions for changes in the OPO

procedural standards in the regulations governing OPOs, such as

requiring OPOs to refer potential tissue donors to eye banks and/or

tissue banks.

Response: We are not making changes to the OPO conditions of

coverage here, as the OPO conditions of coverage are not within the

purview of this regulation. However, we will retain the comments for

reference and continue to review the OPO requirements with a view

toward improving their effectiveness. In addition, we would point out

that the OPO conditions of coverage do 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.'' [42 CFR 486.306(l)] Because this final rule does

establish OPOs as the default gatekeepers for referral of tissues and

eyes, we will regard very seriously the failure of any OPO to refer

promptly all potential tissue and eye donors to the tissue and eye

bank(s) specified by the hospital.

Comment: One commenter cited ``anecdotal evidence'' that managed

care organizations, hospitals, and other providers are reluctant to

provide services for patients with non-survivable brain injuries. The

commenter recommended changing HCFA reimbursement rules for OPOs to

allow costs related to donor clinical assessment prior to declaration

of death. The commenter suggested this would eliminate a barrier to

OPOs' early

[[Page 33863]]

involvement with the potential donor and address hospital concerns

regarding donation-related charges incurred prior to brain death.

Response: Although reimbursement is not within the scope of this

regulation, HCFA will be looking into this matter with a view to

determining what steps appropriately can be taken to ensure that

providers' difficulties in obtaining reimbursement for services to

patients with non-survivable brain injuries does not become a barrier

to organ donation.

Comment: A few commenters responded to our request for suggestions

about how to design or implement the most cost-effective outcome

standard for OPOs related to organ recovery. The commenters called for

a more precise way to measure potential donors for comparison with

actual donors so that each OPO is evaluated in light of its true

potential. Some commenters said that if HCFA adopts an outcome standard

based on conversion of potential to actual donors, the current

performance standards should be reviewed with a view to changing or

eliminating them.

Response: We agree that the current method of using population to

define potential donors may not reflect regional differences in number

and cause of deaths. A recent GAO report [U.S. General Accounting

Office, ``Alternatives Being Developed to More Accurately Assess

Performance (GAO/HEHs-98-26),'' (November 1997)] noted that unless OPO

performance is measured according to the number of potential donors,

HCFA cannot determine OPOs' effectiveness in acquiring organs. We agree

with the conclusions of the GAO report and will be evaluating two

methods suggested by the GAO for more accurately identifying the number

of potential donors in an OPO's service area: death record review and

modeling. We also will be evaluating the results of the study of death

record reviews being conducted by the Association of Organ Procurement

Organizations in conjunction with the American Congress for Organ

Recovery and Donation (ACORD) and a methodology for estimating

potential donors, which is being developed by Harvard Medical School,

the Harvard School of Public Health, and the Partnership for Organ

Donation. If the current method of using population to estimate the

number of potential donors in an OPO's service area is changed, we will

review all OPO conditions of coverage to determine their

appropriateness in view of that change.

Comment: One commenter suggested hospitals should be allowed to set

minimum credentials for OPO personnel working in their hospitals. The

commenter said surveys of donor family satisfaction and satisfaction of

hospital personnel with OPO personnel should be permitted, and

hospitals should have the option of terminating their contract with the

OPO if a workable solution is not found.

Response: There is nothing in the regulation that precludes a

hospital from surveying donor families or hospital personnel to

determine their level of satisfaction with the OPO. However, standards

for OPO personnel are a HCFA responsibility. [42 CFR 486.306] A

hospital dissatisfied with its designated OPO has the option of

requesting a waiver from HCFA permitting an agreement with an OPO other

than the OPO designated for the service area in which the hospital is

located. To qualify for a waiver, the hospital must submit data to HCFA

showing that the waiver is expected to increase organ donations and

will ensure equitable treatment of patients referred for transplants

within the service area served by the hospital's designated OPO and

within the service area served by the OPO with which the hospital seeks

to enter into an agreement.

Resolution of Disputes

Comment: Several commenters suggested there should be a mechanism

for ``due process'' if there are disagreements between OPOs and

hospitals or between OPOs and tissue and eye banks. One commenter

suggested that the rule should require an agreement as to the content

of the protocols signed by both the OPO and the hospital. The commenter

suggested that the Department should set up a system for mediating and,

if necessary, arbitrating disputes. In the case of arbitration, the

decision of the Secretary would be final.

Response: We have tried to structure a final rule that will

encourage hospitals and OPOs to work together to alleviate the critical

shortage of organs for transplant. We have included a requirement that

hospitals and OPOs work ``collaboratively'' in advising families of

potential donors of their donation options. We have included a

requirement that hospitals work ``cooperatively'' with OPOs and tissue

and eye banks in reviewing death records, educating hospital staff

about donation issues, and maintaining potential donors. We have

included a requirement that the OPO consult with a tissue and an eye

bank in developing protocols for identification and referral of tissues

and eyes. We believe these requirements will obviate the need for

dispute resolution mechanisms, such as mediation or arbitration.

However, based on the correspondence we have received, we understand

that, in some communities, relationships between hospitals and OPOs and

between OPOs and tissue and eye banks are contentious and that

collaboration may prove to be difficult.

We know that hospitals, OPOs, and tissue and eye banks share our

view that organs and tissues are a precious national resource and that

only through the collaborative efforts of all parties can lives be

saved. As one commenter wrote, ``at risk in * * * this issue are

patient lives that could either be saved or be unnecessarily lost by

the success--or failure--of hospitals and OPOs working together.''

We will monitor donation rates and OPO and hospital performance

after this rule becomes effective. In those instances where tensions

among the actors in the donation process are hindering improvements in

organ donation, we will explore ways in which we might play a

constructive role in encouraging and facilitating a successful local

solution.

Family Consent to Donation

Comment: One commenter expressed concern that strengthening the

role of the OPOs in the donation process will encourage OPOs to apply

too much pressure on bereaved families in order to meet HCFA

performance standards. The commenter suggested the final rule should

address the need for sensitivity toward families and their religious

views and the need for education of hospital staff in sensitivity to

families' grief. Another commenter cited OPO ``quotas'' and hospitals'

concerns about lack of control as reasons why the OPO should not be

involved with the potential donor's family until the family has agreed

to donation or requested additional information about donation.

Response: We have no evidence that families of potential donors are

being pressured by OPO or hospital staff and no reason to believe that

this change in the hospital conditions of participation would lead to

such a problem. We note however, that the final rule requires

collaboration between the hospital and OPO in informing families of

potential donors of their donation options and also requires hospitals

to encourage discretion and sensitivity with respect to the

circumstances, views and beliefs of families of potential donors. In

addition, the final rule both permits the hospital to choose the

individual who will initiate the request for donation to the family and

ensures that the

[[Page 33864]]

individual initiating the request has been educated in the consent

process.

Although our earlier references to research on the family consent

process emphasize that best practices lead to improved consent rates,

such improvement is achieved in large part through greater sensitivity

to families and their beliefs, their backgrounds, and their grief. For

example, the interview study cited earlier [DeJong W, Franz HG.

``Requesting Organ Donation: An Interview Study of Donor and Nondonor

Families,'' American Journal of Critical Care (1998);7:13-23] discusses

family demographic characteristics, such as race, ethnicity, and

education and concludes, ``This information should be used to remind

the health care team to be especially attentive to concerns that

certain families might have and to take special care to meet the

families' informational and emotional needs. Healthcare providers

should approach the family with the belief that a donation is possible

and should take steps to ensure the family is treated with respect and

care.''

The services provided by Nebraska Health Systems are an example of

what hospitals and OPOs can do to increase family consent to donation

while providing emotional support and counseling to grieving families.

This transplantation facility offers a program called Acute Bereavement

Services, staffed by organ recovery personnel, nurse resource

coordinators, and pastoral care staff. These individuals are available

at any time to guide discussions with survivors concerning potential

organ and tissue donation; act as a resource for family questions about

funeral arrangements, coroner notification, autopsy consent, grief

resources, hospital leave-taking, religious resources, and ritual; act

as a resource for staff questions about notification of organ recovery

staff; and act as advocates for the immediate grief needs of survivors.

Nebraska Health Systems instituted their Acute Bereavement Services

because ``we wanted to have a positive impact on the grieving process

even after our medical responsibilities to the patient and family

ended.'' In 1996, the Nebraska Health Systems family consent rate was

75 percent. Hospitals interested in obtaining more information about

Acute Bereavement Services can contact Nebraska Health Systems at Box

984075, 600 South 42nd St., Omaha, NE 68198-4075, Attention: Marsha

Morien.

Comment: Some commenters voiced concern about the use of the word

``discretion'' in the text of the regulation. The regulation requires

that hospitals ``encourage discretion and sensitivity with respect to

the circumstances, views, and beliefs of the families of potential

donors.'' Commenters suggested there is a risk that in some

circumstances the term ``discretion'' might be used as a justification

to avoid advising eligible families about organ donation because of a

presumption on the part of hospital staff that the family would not be

receptive because of their intense grief, socioeconomic status, race,

or religion. The commenter cited a study that found minority families,

particularly African Americans, were less likely to be asked about the

option of donation. The commenter suggested this might be due to

hospital staff perception that ethnic minorities are opposed to

donation, despite ample evidence that minorities donate in significant

numbers. One OPO commented that the greatest impediment to donation is

a hospital's conclusion that consent cannot be obtained. The OPO

stated, ``In such a situation, the OPO has lost a potential donor

without ever being afforded the opportunity to act.''

Response: Our use of the term ``discretion'' in the text of the

regulation reflects the statute's use of that term in section

1138(a)(1)(A)(ii) of the Act. However, we are grateful for an

opportunity to point out that our use of the term ``discretion'' in the

text of the regulation should not be construed to mean that hospital

staff should, under any circumstances, make a judgment that certain

families should not be approached about donation. 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.

Comment: Many commenters strongly supported our language regarding

notification of donor families. Many mentioned the research that shows

that highest family consent rates are obtained when OPOs and hospitals

collaborate. One OPO reported an 87 percent consent rate when OPO staff

and hospital staff collaborate in the request to the family and a 38

percent consent rate when the hospital staff approach the family alone.

Some commenters emphasized that hospital staff should be free to

continue to participate in advising families of their donation options.

However, one commenter suggested that if hospital staff consent rates

differ markedly from OPO staff consent rates, the hospital should be

required to return consent responsibility to the OPO or provide

training to hospital staff. Some commenters recommended that the

regulation specify that only trained personnel (whether OPO or hospital

staff) are permitted to advise families of potential donors of their

donation options. One commenter pointed out that in Pennsylvania, which

has a routine referral law, hospital personnel can become designated

requestors only after undergoing training by the OPO.

Response: We appreciate the commenters' support for the final

rule's emphasis on collaboration in notifying families of potential

donors of their options for donation. Research has shown best practices

include participation of both OPO personnel and hospital staff in the

process, with the actual request for donation made by OPO personnel. We

encourage hospitals and OPOs to consider these best practices when

determining how this process will occur. We agree with the commenters

who suggested that only personnel trained in the consent process be

permitted to approach families with a request for donation, and we have

included that provision in the final regulation. We have also modified

the text of the regulation to make it clear that hospitals have

discretion in determining who will initiate the request for donation.

Comment: Some commenters suggested further strengthening the rule

by giving the OPOs even more control over the process. For example, one

commenter suggested the rule be strengthened to give OPOs the sole

responsibility for initiation of the request for organs or tissues. The

commenter mentioned that currently OPOs are being held accountable by

the Federal government but have not been given the tools to increase

donation rates. Several commenters urged us to eliminate the

requirement for collaboration between the OPOs and the hospital in the

consent process and make it clear that only OPO staff should be

permitted to approach the family about donation.

Response: We are sympathetic to the commenters' point of view. OPOs

have been in the difficult position of having to meet specific

performance standards for organs donated and transplanted, while at the

same time having less than total control over the donation and

transplantation processes. However, we disagree that only OPOs should

be permitted to advise families of potential donors of their donation

options. As stated elsewhere in this preamble, studies show that the

highest family consent rates are a result of collaboration between OPOs

and

[[Page 33865]]

hospitals. The participation of hospital staff is critical both to

ensure that a family understands and accepts the brain death of the

potential donor and to provide compassionate support to the family. A

1987 study of donor family perspectives concluded that the hospital

nursing staff are in the best position to have a positive effect on

donor families' attitudes toward their donation experiences and,

ultimately, as families share their experiences with family and

friends, in the future availability of organs for transplant.

[Bartucci, MR. ``Organ Donation: A Study of the Donor Family

Perspective.'' Journal of Neuroscience Nursing. 1987; 19:305-309] The

final rule gives OPOs considerably more control over the donation

process while at the same time encouraging collaborative relationships

between OPOs and hospitals.

Death Record Reviews

Comment: Many commenters strongly supported the requirement for

death record reviews. One commenter, a hospital association from a

State with a routine referral law, suggested that death record reviews

be performed only by licensed OPOs. Another commenter encouraged us to

take the next step by providing support and resources to allow

compilation of medical records review data in a centralized database,

and by accelerating the development and application of methods to

accurately estimate underlying donor potential in hospitals and OPOs.

Response: We agree that death record reviews are an essential

component of this final rule. We expect that requiring hospitals to

cooperate with OPOs, tissue banks and eye banks in reviewing death

records will allow the OPOs, tissue banks and eye banks the opportunity

to review death records to determine donor potential, monitor hospital

compliance, and identify areas where education in a hospital's organ

donation procedures is needed. The final rule will permit the hospital,

OPO, tissue bank, and eye bank to determine who will perform the death

record reviews. Providing resources for compilation of medical records

review data is beyond the scope of this regulation. However, we are

interested in a further exploration of how such a database could be

useful in increasing organ donation. We are currently considering

various methods for estimating donor potential and are also awaiting

the outcome of a review of hospital death records being conducted by

the Association of Organ Procurement Organizations in conjunction with

the ACORD.

Comment: A few commenters were concerned that giving outside

agencies access to death records would be disruptive or would

jeopardize patient confidentiality.

Response: In requiring hospitals to work cooperatively with OPOs,

tissue, and eye banks in performing death record reviews, we are

confident that a system can be worked out among all parties to minimize

disruptions. Likewise, we would expect that all parties can come to an

agreement on the protocols that will be used both to perform death

record reviews and analyses. We also expect all parties involved to use

the resulting data in a manner that ensures patient confidentiality is

not threatened. Note that both hospital and OPO regulations require

hospitals and OPOs to have procedures for ensuring the confidentiality

of patient records. Hospitals and OPOs must ensure that unauthorized

individuals cannot gain access to or alter patient records. Hospitals

and OPOs must also ensure that original medical records are released

only in accordance with Federal or State laws, court orders, or

subpoenas. [See 42 CFR 482.24(b)(3) and 42 CFR 486.306(o).] We believe

that sufficient safeguards exist in Federal and State law to protect

the confidentiality of hospital death records.

Comment: One commenter asked that HCFA provide explicit authority

for OPOs to conduct audits of hospital organ and tissue donation

performance to be provided upon request to HCFA or the Joint Commission

on Accreditation of Health Care Organizations. Confidentiality would be

assured as a condition of OPO designation.

Response: Although this regulation does not give OPOs specific

authority to conduct death record reviews, it does require that

hospitals work cooperatively with their OPOs in reviewing death

records. This means that a hospital must develop a protocol which

permits the OPO access to death record information that will allow the

OPO to assess the hospital's donor potential, assure that all deaths or

imminent deaths are being referred to the OPO in a timely manner, and

identify areas where both OPO and hospital staff performance might be

improved.

General Comments

Comment: One commenter cited ``concerns in the medical community''

about the broad language of the proposed rule and the possibility that

unintended and unanticipated actions could be taken. The commenter

suggested that we hold meetings with interested parties to assess their

understanding of the language and request suggestions for clarifying

the proposed rule.

Response: We carefully considered all comments we received from

hospital and medical associations; tissue and eye banks and their

professional organizations; transplant and donor organizations; OPOs;

and other organizations and individuals. In addition, we have tried to

be quite specific in this preamble in our discussions of the meaning of

the regulation text and in our suggestions for implementation.

Comment: Some hospital associations expressed concern that OPOs

would establish policies that are unworkable because the proposed rule

provides no guidance to OPOs about the policies they should establish.

The hospital associations gave as an example, the proposed requirement

that the hospital assure that the family of each potential donor knows

of its option to donate or decline to donate organs or tissues. They

suggested that if an OPO defined potential organ donor as any patient

who dies, the hospital would be required to inform the families of all

deceased patients of their donation options even if it knew the

patients were not medically suitable to be donors.

Response: We believe the final rule's emphasis on cooperation and

collaboration between hospitals and OPOs will ensure protocols are

developed and implemented that will function efficiently for both

hospitals and OPOs. In addition, since OPOs must meet regulatory

performance standards, it certainly is in their best interests to

establish policies that are workable.

Comment: One commenter stated that the key to success of protocols

for defining and referring donors will be ensuring that the burden on

hospitals to carry out the protocols is not unduly heavy. The commenter

suggested there should be some latitude in local protocols but that all

protocols should strive to meet three criteria: (1) Ensuring that no

medically suitable potential organ donor is missed; (2) minimizing the

number of non-eligible cases that are referred; and (3) ensuring

referral well before discontinuation of ventilation and cardiac arrest.

Others echoed the third criterion in asking us to clarify that,

whenever possible, referrals should be made when death is imminent to

ensure that brain-dead or near brain-dead patients are maintained until

a referral is made and are not referred to the OPO after mechanical

support has been discontinued.

[[Page 33866]]

Response: We agree with the commenters' first and third criteria

and believe the final rule will achieve these goals. OPOs are the

entities familiar with the parameters for transplantable organs used by

transplant hospitals and surgeons. Routine referral coupled with the

OPO's determination of medical suitability increases the likelihood

that no medically suitable potential donors are missed.

The requirement for timely referral at death or when death is

imminent means that hospitals must make referrals both before a

potential donor is removed from ventilator and while the potential

donor's organs are still viable. Timely referral also means that the

hospital must notify the OPO about potential donors early enough in the

process to allow sufficient time for the family of the potential donor

to make an informed decision about donation. We added these

requirements to the final rule to minimize the possibility that organs

will be lost to medical complications. One recent study noted that

without aggressive support, cardiac arrest occurs in 20 percent of

potential donors within 6 hours after the declaration of brain death

and in 50 percent of donors within 24 hours. The authors conclude that

delays in referrals may reduce the availability of organs since

hemodynamic instability and cardiac arrest can develop relatively soon

after brain death and emphasize that early identification and

intervention are crucial for the successful recovery of organs.

[Hauptman PJ, O'Connor KJ. ``Medical Progress: Procurement and

Allocation of Solid Organs for Transplantation,'' New England Journal

of Medicine; 336:422-431]

With respect to the commenters' second suggested criterion, we

would prefer also to minimize the referrals of potential donors later

determined not to be medically suitable. We believe such an approach is

implicit in our current regulation which permits hospitals to develop

protocols for potential donors and refer only those cases to OPOs.

However, as discussed previously, this approach has resulted in a

significant percentage of potential donors not being identified.

Comment: Some commenters suggested we include provisions and

funding for public education, which could be a cooperative effort by

the OPOs and hospitals. One commenter questioned the need for any of

the provisions in the proposed rule and implied the best way to

increase the donation rate is to educate the public.

Response: We agree with the commenters that public education about

organ donation is important and a variety of efforts have been and will

be needed to enhance public awareness of the benefits of organ

donation. The Department of Health and Human Services launched the

National Organ and Tissue Donation Initiative with dozens of partners

in December 1997. One of the three goals of the initiative is to build

public awareness about the essential role of families in consenting to

donation. The initiative features the Coalition on Donation's message,

``Organ and Tissue Donation: Share your life. Share your decision'' to

underscore the need for family discussion about donation. The

Department also has a new site on the Internet at http://

www.organdonor.gov to provide up-to-date information to the public

about organ and tissue donation and transplantation.

However, we do not believe we should rely exclusively on that as a

strategy to increase donation. If hospitals do not identify potential

donors, if families of potential donors are not asked to donate, or if

those families are asked in a way that is unlikely to lead to their

consent for donation, then public support for organ donation is

immaterial.

Comment: Several commenters suggested we expand the definition of

organ to include small bowel or intestine.

Response: We will not expand the definition of organ at this time.

Before moving forward, we will need to assess fully the policy

considerations of expanding the definition of organ to include small

bowel or intestine. However, we will retain these comments with a view

toward consideration of expanding the definition of organ in a future

regulation.

Comment: A rural hospital suggested we take into account rural

frontier areas when finalizing the regulation. They pointed out that

their closest tertiary facility is 300 miles away. Another commenter

recommended an exemption from the regulation for hospitals without

potential donors, such as those facilities that lack ventilator support

capabilities, do not have ICUs and do not provide trauma, neurology or

neurosurgery services.

Response: We do not intend to establish exemptions for particular

types of hospitals at this time. We do not believe routine referral

will be burdensome to these small hospitals, and we believe that the

information provided to the OPOs through the referral calls made by

these hospitals may prove to be useful for organ, tissue, or eye

donation.

Comment: A commenter pointed out that studies have shown that

transplant hospitals as a group are no more effective in organ donation

than non-transplant hospitals. The commenter recommended an extra level

of donation accountability for transplant hospitals.

Response: We believe the requirements contained in the final rule

will maximize the number of transplantable organs yielded by every

hospital, making it unnecessary to have a different level of

accountability for transplant hospitals. We agree that transplant

hospitals should be especially active in identifying potential donors.

However, we intend to hold all hospitals to the same level of

accountability, that is, to use their best efforts to respond to the

critical organ shortage.

Comment: Three commenters described proposed regulations or

existing laws in their States that require hospitals to develop their

own protocols for organ donation. The commenters expressed concern that

the proposed rule is in conflict with those State laws because it would

remove a hospital's authority under State law to determine a potential

donor's medical suitability.

Response: We do not believe the final rule is in conflict with the

spirit of the State legislation described by the commenters, which

appears to have been written for the purpose of increasing organ

donation. We note that in the 1980s, 44 States and the District of

Columbia passed legislation designed to increase organ donation by

requiring hospitals to develop protocols for identifying potential

organ donors and informing families of their option to donate, and it

is clear from the research on potential donors that have not been

identified by hospitals that the laws have been inadequate. In

response, States have begun to pass routine referral laws. We would

also point out that the Federal regulation would supersede both State

law and State regulations to the extent that it presents otherwise

irreconcilable conflicts with State policies.

Comment: One commenter had several questions related to how various

issues should be handled in cases where two or more OPOs are operating

in the same area, such as whether hospitals would be responsible for

two or more sets of criteria from these OPOs.

Response: The regulations at 42 CFR Part 486, Conditions for

Coverage for Organ Procurement Organizations, specifically

Sec. 486.316, states that HCFA designates only one OPO per service

area. A hospital must enter into an agreement only with the OPO

designated to serve the area in which

[[Page 33867]]

the hospital is located unless HCFA has granted the hospital a waiver.

Thus, a hospital would never be permitted nor required to have an

agreement with more than one OPO at a time.

Hospitals' Provision of Transplant Data and Hospital Accountability

Comment: Several commenters urged us not to add outcome standards

to the regulation because they would be too prescriptive. One commenter

suggested individual hospitals should decide whether they need to

monitor their outcomes.

Response: This regulation does not include numerical organ donation

goals for hospitals.

Comment: An OPO pointed out that a hospital cannot (except with HHS

approval) choose its OPO and is at the mercy of how well the OPO

performs. The commenter suggested that to ensure hospitals' cooperation

and to ensure they are not evaluated on the basis of their OPOs'

performance, a provision be added to the final rule that states a

hospital has met its obligations under section 1138 of the Act if it

has entered into an agreement with an OPO designated by HCFA, the OPO

certifies that the hospital has complied with the agreement and

protocols, and the hospital has authorized the OPO to determine medical

suitability and to make requests for donation.

Response: We see no need to include this specific language in the

regulation. However, we would agree that if a hospital has met the

requirements in the regulation, then it is likely the hospital has met

its obligations under section 1138 of the Act, regardless of whether

the OPO's performance has been satisfactory or unsatisfactory. Meeting

the requirements of the regulation include, but are not limited to,

referring all deaths to the OPO and ensuring that the family of every

potential donor determined by the OPO to be medically suitable for

donation has been advised of its donation options by an OPO

representative or a designated requestor.

Comment: One commenter suggested oversight of the hospitals' actual

participation in the process, which could be assured through death

record reviews, audit results, or other record keeping to demonstrate

the hospitals' level of compliance. The commenter added that this

should be enforced by Medicare surveyors, and a second commenter urged

us to discuss our plans for educating surveyors to ensure that

hospitals will work assiduously to meet organ donor identification,

referral and other related requirements. Another commenter suggested

that hospitals be required to maintain records of a quality improvement

process that supports its protocols. One commenter stated that they

would support the inclusion of an assessment of organ donation

procedures as part of a hospital's overall quality assessment and

performance improvement process. The commenter added that such a

provision would establish a hospital's accountability for actions it

can control. Some commenters recommended including performance

standards for hospitals to measure the variance between the number of

potential donors, referrals, and actual donations. The commenters added

that OPOs should participate in developing performance indicators based

on documented best practices.

Response: Surveyors and HCFA regional offices will oversee

compliance with the requirements of this regulation. However, surveyor

procedures are beyond the scope of this regulation. The proposed rule

for the hospital conditions of participation does not propose a

specific set of quality indicators or objective performance measures be

used. Instead, each hospital would be allowed flexibility to identify

its own measures of performance for the activities it identifies as

priorities in its quality assessment and performance improvement

strategy. We recommend that every hospital make organ donation one of

its priorities for quality assessment and performance improvement.

Death record reviews are a powerful tool hospitals can use in their

quality assessment and performance improvement strategies. In addition,

we strongly recommend that OPOs perform death record reviews and advise

hospitals of any failure to identify or refer potential donors or to

advise families of potential donors of their donation options.

Comment: Many commenters suggested that the proposed rule must be

strengthened to hold hospitals accountable if they do not cooperate

with OPOs. Several commenters stated that the language of the proposed

rule falls short of requiring hospital staff to cooperate with the OPO.

One commenter suggested that we strengthen the language related to

termination of participation in Medicare and Medicaid if a hospital

does not cooperate. Another commenter added, ``We do not see how these

proposed regulations will make a hospital with a ``lukewarm'' interest

in donation become more actively involved in the process.''

Response: We believe the language of the final rule is unequivocal

in requiring a hospital to refer all deaths to the OPO or a third party

designated by the OPO, collaborate with the OPO in assuring that

families of potential donors are advised of their donation options, and

cooperate with the OPO and tissue and eye banks in reviewing death

records and educating hospital staff in donation issues. This

regulation is part of the conditions for hospital participation in the

Medicare and Medicaid programs. Therefore, a hospital will jeopardize

its Medicare and Medicaid certification should it fail to meet the

requirements listed in the regulation.

Hospital Transplant Data

Comment: We received many comments about the requirement in the

proposed rule for transplant hospitals to provide transplant-related

data. Several commenters pointed out that the text of the proposed rule

specifies that the data must be provided to the Organ Procurement and

Transplantation Network, the Scientific Registry, the OPOs, and the

Department of Health and Human Services, whereas the preamble language

specifies that the data must be provided to the Organ Procurement and

Transplantation Network, the Scientific Registry, the OPOs, or the

Department of Health and Human Services. Commenters added that

requiring hospitals to report data to all entities would be

duplicative, burdensome, and would increase administrative costs.

Response: The information provided in the preamble was correct. The

text of the final rule has been changed to state that the data must be

provided as requested to the OPTN, the Scientific Registry, or the

OPOs. The hospital must also provide data directly to the Department

when requested by the Secretary. However, our intent is not to require

hospitals routinely to report identical data to more than one entity,

but rather to authorize direct requests by each of these entities.

Comment: Several commenters asked whether the intent of this

provision is to require hospitals to provide tissue transplant data as

well as organ transplant data. They pointed out that approximately

500,000 tissue transplants are performed annually in the U.S., and

providing tissue transplant data would be a significant burden for

hospitals.

Response: This requirement applies only to organ transplant data.

The text of the regulation has been changed to clarify that hospitals

must provide organ-transplant-related data.

Comment: Many commenters pointed out that the proposed rule was too

vague regarding the type of data hospitals would be required to provide

and how often they would be required to provide it. Commenters asked

for reassurance that data requests will be reasonable.

[[Page 33868]]

One commenter suggested that we specify what data will be requested and

allow time for meaningful comment. The commenter added, ``In the

absence of this specificity, the claim on page 66754 of the Federal

Register that these requirements are usual and customary in the conduct

of hospital business are without foundation.'' Another commenter asked

that we specify the branch of the Department that will receive the

data.

Response: At this time, we have not determined the type of organ

transplant data that may be requested by the Department. We included

this provision to give the Department the flexibility to request data

from transplant hospitals in the event that needed data cannot be

obtained expeditiously from the OPOs, the OPTN, or the Scientific

Registry. Data may be needed by HCFA, the Health Resources and Services

Administration (HRSA), or the Office of the Secretary, but, under this

regulation, data could be requested by any agency within the

Department. Note that a similar provision regarding the mandatory

reporting of data by transplant hospitals also is contained in a

related regulation. [See final rule with comment period, Organ

Procurement and Transplantation Network [98-HRSA-01, 63 FR 16295]

published April 2, 1998, effective October 1, 1998.] In accordance with

42 CFR 121.11(a)(2)(record maintenance requirements for OPOs and

transplant programs) and 121.11(b)(2) (reporting requirements for OPOs

and transplant hospitals) these programs are required to maintain and

report to the OPTN, the Scientific Registry, and the Secretary data

concerning, among other things, each potential donor identified.

Therefore, the requirement in this (HCFA) rule, when considered with

the requirements in the OPTN rule, will enable the Department to obtain

information routinely from all transplant hospitals and OPOs in support

of donation programs under this authority.

Comment: Several commenters expressed concern about the

confidentiality of the data and pointed out the extremely sensitive

nature of transplant patient data. One commenter stressed that because

the patient population is relatively small, it is difficult to protect

patient confidentiality, even when patient identifiers are removed from

the data.

Response: HCFA's primary intent is to use requested data internally

to assess whether a transplant hospital is qualified to participate (or

continue to participate) in the Medicare program and monitor organ

donation. We agree that the confidentiality of donor and transplant

recipient records must be protected and are confident that Federal and

State laws provide adequate safeguards. No additional specific

provisions to protect confidentiality are required in this regulation.

Comment: One commenter suggested that the public have access to all

data provided by the transplant hospitals. However, several commenters

warned that release of data without proper analysis and verification

can result in dissemination of inaccurate or misleading information.

One commenter noted that release of such data may harm individuals or

have a negative impact on organ donation.

Response: Section 121.11(b)(1)(v) of the recent OPTN regulation

[98-HRSA-01, 63 FR 16295] requires the OPTN and the Scientific Registry

to provide data which is to be used for bona fide research or analysis

purposes, to the extent that resources permit, or as directed by the

Secretary. Section 121.11(b)(1)(vi) requires the OPTN and the

Scientific Registry to provide data to the public. Section 121.11(b)(2)

requires that hospitals and OPOs provide data directly to the

Department upon request and that they may not impose restrictions on

subsequent redisclosure. The Secretary has requested comments on

whether the provisions ``sufficiently achieve the several important

purposes served by providing information to the OPTN, the Department,

and the public, while protecting patient privacy.''

Another related provision Sec. 121.11, ``Public access to data''

provides that the Secretary may release to the public information that

will serve the public interest. This information would include data on

comparative costs and outcomes at different transplant programs,

information on waiting list time, and information on the frequency with

which transplant hospitals refuse offers of organs for their listed

patients. The preamble to the OPTN regulation notes that release of

this data is consistent with section 375 of the Public Health Service

Act, 42 U.S.C. 274c, which directs the Department to provide

information to patients, their families, and their physicians about

transplantation resources and about the comparative costs and patient

outcomes at each transplant hospital affiliated with the OPTN.

IV. Provisions of the Final Rule

We are adding Sec. 482.45 in regulations to add the new

requirements concerning organ procurement organizations and transplant

hospitals. The final rule strengthens the role of OPOs in the donation

process, encourages the use of best practices, and provides a framework

for better collaboration among organizations involved in organ, tissue,

and eye donation with the goal of making transplants more readily

available to the many patients who need them. We are confident these

revisions to the current hospital conditions of participation will

narrow the gap between the number of deaths of patients on the waiting

list and the number of organs available for transplant.

The final rule will enable hospitals and OPOs to take advantage of

the most recent research in organ donation by using protocols that have

proved successful for referring potential donors, obtaining family

consent for donation, educating OPO and hospital staff, and reviewing

death records. We have written the provisions of this final rule to

enable hospitals and OPOs to take advantage of these best practices in

order to increase organ donation rates nationwide.

In view of the research that has been done in the field of organ

donation, the demonstrated increase in organ donation rates in States

that have passed routine referral laws, and the comments we have

received, we believe that routine referral of all deaths is the most

effective way to increase organ donation rates substantially.

However, the final rule does not mandate how best practices are to

be applied at the local level. It is designed to maximize organ

donation while allowing local communities a certain amount of

flexibility in applying the rule to their local situation. The rule

takes this approach in order to encourage innovation at the local level

and to assure that successful alternative approaches are not disrupted.

For example, although the final rule specifies that the individual

requesting donation from the family of a potential donor must be

trained in the family consent process, it allows the hospital to decide

whether that individual will be an OPO representative, a tissue bank or

eye bank representative, or a hospital employee and encourages OPOs and

hospitals to collaborate in defining how the process will occur

[Sec. 482.45(a)(3)].

There are a number of sources of information and guidance about the

most recent research in organ donation for OPOs and hospitals that want

to ensure their protocols reflect best practices. One of these is The

Partnership for Organ Donation, Inc., Two Oliver St., Boston, MA 02109-

4901. The Partnership is an independent, nonprofit organization that

sponsors research in organ donation and has worked with hospitals and

[[Page 33869]]

OPOs across the United States to improve organ donation.

The current regulations require the governing board of a hospital

to have a written protocol to identify potential organ donors and carry

out the other requirements of section 1138 of the Act. We have revised

how these requirements are articulated, in keeping with the way in

which we are generally transforming these conditions of participation

for hospitals. The final rule requires that the hospital actually carry

out specified responsibilities. For example, the hospital must contact

the OPO or its designee about every death or imminent death that occurs

in the hospital. This requirement will relieve the hospital of the

responsibility for keeping current with changing potential donor

criteria and determining the medical suitability of potential organ

donors (unless the hospital has an alternative arrangement with its

tissue and eye banks in which the hospital determines the medical

suitability of tissue and eye donors) and will ensure that no potential

donors are missed.

The Commonwealth of Pennsylvania passed legislation effective in

March 1995, requiring that hospitals report all deaths to the OPO. The

OPO for southeastern Pennsylvania, Delaware and southern New Jersey

(Delaware Valley Transplant Program) has seen a 40 percent increase in

organ donation since enactment of the law. In contrast, since 1990, the

organ donation rate nationwide has increased an average of less than 3

percent per year and, as noted above, remained essentially unchanged in

1997. Other OPOs that have instituted routine referral within some

hospitals in their service areas have seen similar, substantial

increases in those hospitals. One OPO reported that two of their

hospitals had their first organ donors in 1997, yielding five organs

for transplantation. Another OPO that uses routine referral has seen

their consent rate for organ donation among African Americans rise from

32.7 percent in 1991 to 68.9 percent in 1997.

The final rule specifies that the hospital must ensure, in

collaboration with the OPO, that the family of each medically suitable

potential donor identified by the OPO is advised of the right to donate

or decline to donate. This provision is based on research that

indicates that consent to organ donation is highest when the formal

request is made by OPO staff or by OPO and hospital staff together

rather than by hospital staff alone. While we require collaboration, we

also recognize that hospital staff may wish to perform this function

and may do so when properly trained. Under this final rule, the

hospital may choose to have OPO staff contact potential donor families,

have hospital and OPO staff jointly perform this function, or rely

exclusively on hospital staff. If hospital staff, rather than organ

procurement coordinators, initiate the request for donation to the

family, it is important that they be trained in best practices for

advising the family of their options and initiating the request for

donation. Therefore, the rule requires that hospital staff who initiate

the request for donation must be designated requestors. A designated

requestor is defined in the regulation as an individual who has

completed a course offered or approved by the OPO and designed in

conjunction with the tissue and eye bank community in the methodology

of approaching potential donor families and requesting organ or tissue

donation. The Pennsylvania routine referral legislation also requires

that hospital employees complete a course in how to approach families

and explain their donation options.

One recent study demonstrated a 47 percent increase in consent

rates when best practices are used. [Gortmaker SL, Beasley CL, Sheey E,

et al, unpublished data] Another recent study demonstrated that

training of hospital staff about protocols for organ donation is

significantly associated with superior rates of organ donation.

However, the study also demonstrated that current levels of training

about organ donation are inadequate. [Evanisko MJ, Beasley, CL,

Brigham, LE ``Readiness of Critical Care Physicians and Nurses to

Handle Requests for Organ Donation.'' American Journal of Critical Care

(1998; 7:4-12]

The final rule requires a hospital to ensure that it works

cooperatively with the OPO, a tissue bank, and an eye bank in educating

staff on donation issues, reviewing death records to improve

identification of potential donors, and maintaining potential donors

during necessary testing and placement of donated organs and tissues

[Sec. 482.45(a)(5)]. Review of death records is the key method an OPO

uses to determine a hospital's donor potential. It allows the hospital

to develop strategies for improving donation and allocating resources

to educate hospital staff. Review of death records also enables

hospitals to recognize missed opportunities for organ donation and to

identify hospital, OPO, and recovery staff who may need additional

education.

The final rule mandates that a hospital 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 [Sec. 482.45(a)(2)]. This agreement can be used to

spell out whether the OPO will determine medical suitability for tissue

and eye donation and handle the referral process for tissue and eye

donors or whether an alternative referral process will be used. If the

OPO determines medical suitability and refers tissue and eye donors, it

must do so using the definition of potential tissue and eye donor and a

notification protocol developed in consultation with the tissue bank

and eye bank designated by the hospital. An alternative arrangement

might, for example, specify that the hospital will refer potential

tissue and eye donors directly to the tissue bank and eye bank. We

added these requirements in the final rule to ensure that tissue and

eye banks have potential tissue and eye donors referred to them

appropriately and expeditiously. It is important to note when

discussing agreements between hospitals, tissue banks and eye banks,

that some OPOs are also tissue and/or eye banks. This regulation does

not preclude a hospital from having a single agreement with such an OPO

which encompasses the services the OPO will provide in regard to

organs, tissues, and eyes, in lieu of separate agreements with an OPO,

a tissue bank, and an eye bank.

The final rule stresses cooperation and collaboration between all

parties. It is our expectation that in communities where hospitals,

OPOs, and tissue and eye banks have not yet developed cooperative

relationships, these requirements will encourage all parties to work

together with the best interests of their communities in mind to

establish protocols that will increase organ, tissue, and eye donation

rates.

The final rule requires transplant centers to provide requested

organ-transplant-related data to the OPTN, the Scientific Registry, the

OPO, or the Department, as requested by the Secretary

[Sec. 482.45(b)(3)]. Currently, transplant centers report data to the

OPTN, the OPO, and the Scientific Registry regarding the disposition of

organs made available for transplant. These data include information

regarding why a center declines the offer of a donated organ,

information regarding patients waiting for transplants, information on

those who have received a transplant, follow-up data on patients who

have received a transplant, and information on those offered an organ

for transplant but declining to use the organ at the time. At the time

the proposed rule was published, submission of these data by transplant

centers to the OPTN was voluntary.

[[Page 33870]]

However, a final rule with comment period, Organ Procurement and

Transplantation Network [98-HRSA-01, 63 F.R. 16295, published April 2,

1998, effective October 1, 1998] has made reporting by transplant

centers mandatory. In accordance with 42 CFR 121.11(a)(2) (record

maintenance requirements for OPOs and transplant programs) and

121.11(b)(2) (reporting requirements for OPOs and transplant hospitals)

these programs are required to maintain and report data to the OPTN,

the Scientific Registry, and the Secretary. Therefore, the requirement

in this HCFA final rule, when considered with the requirements in the

OPTN rule, will ensure that data will be available to implement section

1138 of the Act to operate the OPTN and to obtain information from the

Scientific Registry, and to provide information to the Secretary,

patients, their families, physicians, and the public.

V. Regulatory Impact Statement

We have examined the impact of this rule as required by Executive

Order 12866 and the Regulatory Flexibility Act (Public Law 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits, including

potential economic, environmental, public health and safety effects,

distributive impacts, and equity.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 through 612)

requires agencies to analyze options for regulatory relief for small

entities. Consistent with the RFA, we prepare a regulatory flexibility

analysis unless we certify that a rule will not have a significant

economic impact on a substantial number of small entities. For purposes

of the RFA, we treat most hospitals and most other providers,

physicians, health care suppliers, carriers, and intermediaries as

small entities, either by nonprofit status or by having revenues of $5

million or less annually. Individuals and States are not included in

the definition of a small entity.

Also, section 1102(b) of the Act requires us to prepare a

regulatory impact analysis if a rule may have a significant impact on

the operations of a substantial number of small rural hospitals. That

analysis must conform to the provisions of section 603 of the RFA. For

purposes of section 1102(b) of the Act, we define a small rural

hospital as a hospital that is located outside of a Metropolitan

Statistical Area and has fewer than 50 beds.

The Unfunded Mandate Reform Act of 1995 requires (in section 202)

that agencies prepare an assessment of anticipated costs and benefits

for any rule that may result in an annual mandated expenditure by

State, local, and tribal governments, in the aggregate, or by both the

private sector, of $100 million. The notice has no mandated

consequential effect on State, local, tribal governments, or the

private sector and will not create an unfunded mandate.

We have determined that this regulation is economically significant

under E.O. 12866 and a major rule for purposes of Congressional review

of agency rulemaking.

We do not anticipate that the provisions in this final rule will

have a substantial economic impact on most hospitals, including small

rural hospitals. However, we believe it is desirable to inform the

public of our projections of the likely effects of the final rule on

hospitals, small rural hospitals, OPOs, tissue banks, and eye banks.

There are several provisions in this regulation that will impact

hospitals to a greater or lesser degree. Specifically, hospitals will

be required to have written protocols; have agreements with an OPO, a

tissue bank, and an eye bank; refer all deaths that occur in the

hospital to the OPO; ensure that hospital employees who initiate a

request for donation to the family of a potential donor have been

trained as ``designated requestors''; and work cooperatively with the

OPO, tissue bank, and eye bank in educating hospital staff, reviewing

death records, and maintaining potential donors. It is important to

note that because of the inherent flexibility of this regulation, the

extent of the economic impact of most of these requirements is

dependent upon decisions which will be made either by the hospital or

by the hospital in conjunction with the OPO and/or the tissue and eye

banks. Thus, the impact on individual hospitals will vary and is

subject in large part to their decision making. The impact will also

vary according to each hospital's current organ donation protocols and

level of compliance with existing law and regulation. For example,

eight States already have routine referral legislation, and in several

other States, OPOs and hospitals have routine referral agreements.

The first requirement in the regulation is that hospitals have and

implement written protocols that reflect the various provisions of the

regulation. Currently, under section 1138 of the Act and the existing

regulation, hospitals must have written protocols for organ donation.

Most hospitals will need to rewrite their existing protocols to conform

with this regulation; however, this is clearly not a requirement that

imposes a significant economic burden.

In addition, a hospital must have an agreement with its designated

OPO and with at least one tissue bank and at least one eye bank.

Although the current regulation does not specifically require an

agreement with an OPO, hospitals are required under section 1138 of the

Act and the existing regulation to refer all potential donors to an

OPO. Also, the OPO regulation at 42 CFR 486.306 requires, as a

qualification for designation as an OPO, that the OPO have a ``working

relationship'' with at least 75 percent of the hospitals in its service

area that participate in the Medicare and Medicaid programs and that

have an operating room and the equipment and personnel for retrieving

organs. Therefore, presumably most hospitals already have some type of

agreement with their designated OPO. Although hospitals may need to

modify those existing agreements, the need to make modifications would

not impose a significant economic burden. The current regulation does

not require hospitals to have agreements with tissue and eye banks.

However, we must assume most hospitals have agreements with tissue and

eye banks, since hospitals are the source for virtually all tissues and

eyes.

The provision of the regulation that will have the most impact on

hospitals is the requirement to notify the OPO about every death that

occurs in the hospital. Approximately 400 deaths per year occur in the

average hospital in the U.S. If the average notification telephone call

to the OPO takes five minutes, the hospital will need approximately

four person days per year to make the calls. We believe this is a

generous estimate. One OPO has reported that the referral calls

hospitals make to the vendor that handles their referral calls average

one minute, 20 seconds. An OPO in a State with routine referral

estimates the calls they receive from hospitals, on average, last no

more than three to five minutes. (A call about a ventilator dependent

patient might last an hour, but, of course, these calls are

infrequent.)

Most likely, additional time would be needed by the hospital staff

person to annotate the patient record or fill out a form regarding the

disposition of the call. This paperwork should take no more than five

minutes. Therefore, paperwork associated with the call might add

approximately four person days per year.

[[Page 33871]]

In summary, the impact of referring all deaths to the OPO should be

limited to approximately eight person days per year. Thus, the economic

impact for a hospital of referring all deaths will be small. Although

small rural hospitals have fewer staff than the average hospital, there

are also fewer deaths to report. Therefore, the impact on small rural

hospitals of notifying OPOs of all deaths would be commensurately

small.

Under the regulation, a hospital may agree to have the OPO

determine medical suitability for tissue and eye donation or may have

alternative arrangements with a tissue bank and an eye bank. These

alternative arrangements could include the hospital's direct

notification of the tissue and eye bank of potential tissue and eye

donors or direct notification of all deaths. If a hospital chose to

contact both a tissue bank and an eye bank directly on all deaths, it

would need a total of 16 person days per year (i.e., five minutes per

call (four person days) and five minutes for paperwork (four person

days) in order to call both the tissue and eye bank directly). Again,

the impact is small, and the regulation permits the hospital to decide

how this process will take place. Note that many communities already

have a one-phone-call system in place, and this regulation does not

preclude, and in fact encourages, these local systems. Also, some OPOs

are also tissue banks and/or eye banks. A hospital that chose to use

the OPO's tissue and eye bank services in these localities would need

to make only one telephone call on every death.

This regulation requires that the individual who initiates a

request for donation to the family of a potential donor must be an OPO

representative or a ``designated requestor.'' A designated requestor is

an individual who has taken a course offered or approved by the OPO in

the methodology for approaching families of potential donors and

requesting donation. It is difficult to estimate how much hospital

staff time will be needed for designated requestor training, as it is

dependent both upon the length of the course and the number of

employees the hospital wishes to have trained. An OPO in a State with

similar legislation has a one-day training course for its designated

requestors. The Partnership for Organ Donation, an independent,

nonprofit organization that sponsors research in organ donation and

work with hospitals and OPOs to improve organ donation, offers

intensive two-day training for hospital donation teams. Even if the OPO

requires a two-day training course and the hospital wants to have a

sufficient number of designated requestors to ensure that all shifts

are covered, this provision of the regulation would not have a

significant economic impact on hospitals. In addition, the hospital may

choose to have donation requests initiated by the OPO staff rather than

hospital staff, in which case there is no economic impact.

The regulation requires a hospital to work cooperatively with the

OPO, a tissue bank, and an eye bank in educating hospital staff. We do

not believe education of hospital staff will demand a significant

amount of staff time. For example, the Pacific Northwest Transplant

Bank recently worked with the Oregon Health Sciences University to

educate all 400 nurses and all staff physicians, chaplains, social

workers, and medical interpreters. The OPO transplant coordinator gave

a 15-minute presentation highlighting staff responsibilities and

changes in the hospital protocol, with an emphasis on a more sensitive

family approach. Presentations were given at times convenient for the

staff, such as at regular staff meetings and before and after shift

reports. Clearly, such brief educational presentations, even if given

once a year or more often, would not have a significant impact on

hospitals. Also, most OPOs currently have educational programs for

their hospitals. For example, one OPO has one full-time and eight part-

time staff devoted to hospital staff training for the hospitals in

their service area.

The regulation requires a hospital to work cooperatively with the

OPO, a tissue bank, and an eye bank in reviewing death records. Most

OPOs currently conduct extensive hospital death record reviews. The

hospital's assistance is required only to provide lists of hospital

deaths and facilitate access to records.

Finally, the regulation requires a hospital to work cooperatively

with the OPO, a tissue bank, and an eye bank in maintaining potential

donors while necessary testing and placement of potential donated

organs and tissues take place. If this regulation is successful in

increasing organ donation, hospitals will have more brain dead

potential donors to maintain until family consent is obtained and the

donors' organs are removed. As referenced earlier, The OPO for

southeastern Pennsylvania, Delaware and southern New Jersey (Delaware

Valley Transplant Program) has seen a 40 percent increase in organ

donation since enactment of routine referral legislation in

Pennsylvania in 1995. In contrast, since 1990, the organ donation rate

nationwide has increased an average of less than 3 percent per year. Of

course, we must take into account the fact that eight States have some

type of routine referral legislation, although most of it is quite

recent. Therefore, if we assume that this regulation will result in a

more modest increase of 20 percent (10 percent or 548 additional donors

per year) in the two years following the effective date, there will be

approximately 1,096 additional donors in that two-year period (based on

the 5,475 organ donors in 1997). (Note that the goal of the Organ and

Tissue Donation Initiative is an increase in the organ donation rate of

20 percent in two years.) However, since there are approximately 5,200

short stay hospitals in the U.S., the additional number of donors per

hospital would be quite small.

It is possible that because of the final rule, some small rural

hospitals may have their first organ donors. Therefore, we considered

the impact on a rural hospital of maintaining a brain dead potential

donor on a ventilator until the organs can be placed. Small rural

hospitals with full ventilator capability should have no trouble

maintaining a potential donor until the organs are placed. However,

some small rural hospitals have ventilator capability only so that a

patient can be maintained until he or she is transferred to a larger

facility for treatment. These hospitals would have the equipment and

staffing to maintain a potential donor until transfer to another

facility occurs. Many small rural hospitals do not have ventilator

capability and would be unable to maintain a potential donor however,

small rural hospitals without ventilator capability will still be

obligated to notify the OPO, or a third party designated by the OPO, of

all individuals whose death is imminent or who have died in the

hospital. We do not believe there will be a significant impact on small

rural hospitals no matter what their situation--full ventilator

capability, ventilator capability only for patients who are to be

transferred to a larger facility, or no ventilator capability.

It is important to estimate the costs to OPOs of screening the

significant number of additional calls they will receive. There are 63

OPOs that will receive the referral calls generated by the

approximately 2,080,000 hospital deaths per year. This means that the

average OPO will receive 33,016 referral calls per year (90 referral

calls per day). An OPO may choose to hire a third party vendor to

triage the phone calls or may hire staff to handle the calls in-house.

Currently, some OPOs use a combination of systems, with OPO staff

[[Page 33872]]

handling calls received during business hours and a vendor handling

calls received during non-business hours. One OPO that uses a vendor

pays $1,200 per month for the first 300 calls and $3.20 per call for

each additional call. The vendor's staff enters all necessary

information into a database that can be accessed by the OPO and also

contacts the tissue and eye banks on every call. One vendor that

triages calls for a number of OPOs charges $5 to $10 per call,

depending upon the type of services desired.

An OPO that chooses to have calls handled by OPO staff will have

costs for staff training, additional telephone lines and computers, and

computer software upgrades. One OPO in a State with routine referral

legislation, has 70 percent of the 32,000 calls it receives every year

handled by a vendor and the remainder handled by OPO staff. An OPO

representative estimated their start-up costs to be approximately

$40,000. The OPO pays the vendor $180,000 per year and spends $220,000

per year on salary and benefits for the additional staff that is needed

for routine referral. The OPO has also seen their telephone charges

increase by about 50 percent. However, in spite of these costs, the OPO

has maintained its organ acquisition costs below the national average.

A representative from an OPO in a State that recently passed routine

referral legislation called its start-up costs ``significant.''

However, in the seven-month period since the legislation went into

effect, the OPO's organ donors have increased by 70 percent (when

compared to the nine-month period prior to the legislation), while its

organ acquisition cost has risen just 3 percent.

It is clear that set-up costs for OPOs to handle the increased

calls resulting from routine referral are significant. They include

costs for improving communications and computer systems and hiring and

training staff. Likewise, ongoing costs for OPOs of handling the

increased calls are significant. The OPO that pays its vendor $1,200

per month for the first 300 calls and $3.20 per call for each

additional call would spend approximately $105,280 to screen 32,000

calls per year. An OPO that uses a vendor that charges $10 per call

would spend $320,000 per year to screen 32,000 calls. An OPO that uses

both a vendor and OPO staff might spend more than $400,000 per year to

screen 32,000 calls. However, the critical issue is whether the

acquisition cost per organ will increase significantly. The acquisition

cost per organ is a function not only of the cost per call, but the

number of calls required for each organ, given the system set up by the

OPO. Based on the experience of some OPOs in States with routine

referral, these costs are likely to remain the same or increase only

slightly.

We received many comments about the proposed rule which expressed

concern that the regulation would have a negative impact on tissue and

eye banks. A few commenters even predicted that some eye banks would be

forced out of business. However, the final rule contains safeguards to

ensure that OPOs consult with tissue and eye banks in establishing

protocols for identifying and referring tissue and eye donors to the

tissue banks and eye banks chosen by the hospital. Therefore, we do not

believe there will be a significant impact on a substantial number of

tissue and eye banks.

We expect that this regulation will increase tissue and eye

donations as well as organ donations. A study of the impact of the

Pennsylvania routine referral legislation on tissue and eye donations

was presented at the Fourth International Society for Organ Sharing

Congress and Transplant Congress in July 1997. [Nathan, HM, Abrams, J,

Sparkman BA, et al. ``Comprehensive State Legislation Increases Organ

and Tissue Donations'] This study used data from the Delaware Valley

Transplant Program, the OPO for southeastern Pennsylvania, and found

that although the maximum donor age was lowered from Normal annual percentage increase in organ donation and

transplantation that would occur independent of the impact of this

regulation;

The fact that the Medicare population tends to be sicker

than the general transplant population;

The fact that approximately \1/3\ of kidney transplant

recipients leave Medicare end stage renal disease (ESRD) rolls after

three years if the transplant is successful; and

Reduced costs to the Medicare program for kidney

transplant recipients because they no longer need dialysis.

HCFA actuaries also estimated the cost to the Medicare program of

transplants and follow-up medical care for transplant recipients in FY

2004 without the regulation to be $1,630,000,000. Total costs to the

Medicare program in FY 2004 with this regulation total $1,870,000,000

($1,630,000,000 + $240,000,000). Thus, the regulation will increase the

cost to the Medicare program and associated medical care by

approximately 15 percent in FY 2004.

Note the cost estimate for 1999 does not include the first three

months of FY 1999. Although the regulation's effective date will be in

August 1998, it is not expected that there will be an impact on the

Medicare budget until January 1, 1999.

We attempted to compare the costs to hospitals and OPOs of the

proposed regulation and the final regulation. The proposed regulation

would have permitted OPOs to define both ``potential donor'' and the

notification protocol hospitals would use to refer potential donors. We

cannot quantify the costs of implementing the proposed regulation

because we have no way of knowing with any certainty, what the

individual OPOs would decide to do if given the responsibility of

deciding which deaths would be referred by their hospitals. Some OPOs

might exclude individuals by age; other OPOs might exclude individuals

by clinical category (e.g., HIV positive or metastatic cancer).

However, even absent a comparison of costs, we believe the final

regulation is a more effective mechanism to increasing organ donation.

Referring all deaths is a better approach because it creates a clear

standard for hospitals to follow, it ensures that hospitals will not

erroneously assume that a potential donor should be excluded, it allows

early intervention by the OPO to guide the organ and tissue procurement

process to ensure a successful outcome, and will make it easier to

standardize transplantation waiting time.

In accordance with the provisions of Executive Order 12866, this

final rule was reviewed by the Office of Management and Budget.

VI. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, agencies are required to

provide 60-day notice in the Federal Register and solicit public

comment before a collection of information requirement is submitted to

the Office of Management and Budget (OMB) for review and

[[Page 33874]]

approval. In order to fairly evaluate whether an information collection

should be approved, section 3506(c)(2)(A) of the Paperwork Reduction

Act of 1995 requires that we solicit comment on the following issues:

Whether the information collection is necessary and useful

to carry out the proper functions of the agency;

The accuracy of the agency's estimate of the information

collection burden;

The quality, utility, and clarity of the information to be

collected; and

Recommendations to minimize the information collection

burden on the affected public, including automated collection

techniques.

Therefore, we are soliciting public comment on each of these issues

for the information collection requirements summarized and discussed

below.

Section 482.45(a) Standard: Organ Procurement Responsibilities

The burden associated with the requirements of this section

include; (1) the requirement to maintain protocol documentation

demonstrating that the five requirements of this section have been met,

(2) the requirement for a hospital to notify an OPO and/or tissue bank

of a death, and (3) the time required for a hospital to document and

maintain OPO referral information.

We estimate that, on average, the requirement to maintain protocol

documentation demonstrating that the requirements of this section have

been met will impose one hour of burden per hospital (on 5,200

hospitals) on an annual basis (a total of 5,200 annual burden hours).

The burden associated with the requirement for a hospital to notify

an OPO of every death that occurs in the hospital is estimated to be

approximately 400 calls per year in an average hospital, multiplied by

five minutes per call, for a total annual burden of 34 hours per

hospital (a total of 176,800 annual burden hours). We believe this is a

generous estimate. One OPO has reported that the referral calls

hospitals make to the vendor that handles their referral calls average

one minute, 20 seconds. An OPO in a State with routine referral

estimates the calls they receive from hospitals, on average, last no

more than three to five minutes. (A call about a ventilator dependent

patient might last an hour, but, of course, these calls are

infrequent.)

In addition, time would be needed by the hospital staff person to

annotate the patient record or fill out a form regarding the

disposition of the call. The burden associated with this activity is

estimated that be five minutes per call, multiplied by 400 calls, for

an annual burden of 34 burden hours per hospital (a total of 176,800

annual burden hours).

Under the regulation, a hospital may agree to have the OPO

determine medical suitability for tissue and eye donation or may have

alternative arrangements with a tissue bank and an eye bank. These

alternative arrangements could include the hospital's direct

notification of the tissue and eye bank of potential tissue and eye

donors or direct notification of all deaths. If a hospital chose to

contact both a tissue bank and an eye bank directly on all deaths, it

would need an additional 68 annual hours of burden per hospital (a

total of 353,600 annual burden hours), (i.e., five minutes per call and

five minutes for paperwork in order to call both the tissue and eye

bank directly). Again, the impact is presumed to be small, since the

regulation permits the hospital to decide how this process will take

place. It should be noted that many communities already have a one-

phone-call system in place, and this regulation does not preclude, and

in fact encourages, these local systems. Also, some OPOs are also

tissue banks and/or eye banks. A hospital that chose to use the OPO's

tissue and eye bank services in these localities would need to make

only one telephone call on every death.

Section 482.45(b) Standard: Organ Transplantation Responsibilities

If a hospital performs any type of transplants, it must provide

organ-transplant-related data as requested by the Organ Procurement and

Transplantation Network (OPTN), the Scientific Registry (SR), or the

organ procurement organizations (OPOs). The hospital must also provide

such data directly to the Department of Health and Human Services when

requested by the Secretary.

The new reporting requirement imposed with this section, which is

subject to the PRA, is the requirement on an estimated 300 transplant

hospitals to provide data to 63 OPOs. Based upon discussions with

industry representatives the data that will be requested by the OPO's

is data currently requested and supplied by transplant hospitals to the

OPOs. Therefore, we are assigning one token-hour for the burden

associated with this requirement.

The burden related to the requirement for a hospital to provide

data to the OPTN and SR is currently imposed by the Health Resources

and Services Administration and is approved under OMB number 0915-0157,

with an expiration date of 10/31/99. The burden associated with these

requirements ranges from .1 hour to .4 hours per submission, depending

on donor type. On an annual basis the total number of submissions is

285,600 for a total burden of 39,970 hours. The remaining requirement

that data may be requested by the Secretary, would be collected on an

individual basis and/or during the pursuit of an administrative action,

audit, or investigation, and is therefore not subject to the

requirements of the PRA as defined under 5 CFR 1320.3 (h)(6) and

1320.4.

We have submitted a copy of this proposed rule to OMB for its

review of the information collection requirements in Secs. 482.45(a)

and 482.45(b). These requirements are not effective until they have

been approved by OMB.

If you comment on any of these information collection and record

keeping requirements, please mail copies directly to the following:

Health Care Financing Administration, Office of Information Services,

Information Technology Investment Management Group, Division of HCFA

Enterprise Standards, Room C2-26-17, 7500 Security Boulevard,

Baltimore, MD 21244-1850. Attn.: John Burke HCFA-3005-P

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Building, Washington, DC

20503. Attn.: Allison Herron Eydt, HCFA Desk Officer

List of Subjects in 42 CFR Part 482

Grant programs-health, Health facilities, Medicaid, Medicare,

Reporting and recordkeeping requirements.

For reasons set forth in the preamble, 42 CFR chapter IV is amended

as follows:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

1. The authority citation for part 482 continues to read as

follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42

U.S.C. 1302 and 1395hh), unless otherwise noted.

Subpart B--Administration

Sec. 482.12 [Amended]

2. In Sec. 482.12, paragraph (c)(5) is removed.

Subpart C--Basic Hospital Functions

3. A new Sec. 482.45 is added to subpart C to read as follows:

[[Page 33875]]

Sec. 482.45 Condition of participation: Organ, tissue, and eye

procurement

(a) Standard: Organ procurement responsibilities. The hospital must

have and implement written protocols that:

(1) Incorporate an agreement with an OPO designated under part 486

of this chapter, under which it must notify, in a timely manner, the

OPO or a third party designated by the OPO of individuals whose death

is imminent or who have died in the hospital. The OPO determines

medical suitability for organ donation and, in the absence of

alternative arrangements by the hospital, 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;

(2) Incorporate 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 and eyes are obtained

from potential donors, insofar as such an agreement does not interfere

with organ procurement;

(3) Ensure, in collaboration with the designated OPO, that the

family of each potential donor is informed of its options to donate

organs, tissues, or eyes or to decline to donate. The individual

designated by the hospital to initiate the request to the family must

be an organ procurement representative or a designated requestor. A

designated requestor is an individual who has completed a course

offered or approved by the OPO and designed in conjunction with the

tissue and eye bank community in the methodology for approaching

potential donor families and requesting organ or tissue donation;

(4) Encourage discretion and sensitivity with respect to the

circumstances, views, and beliefs of the families of potential donors;

(5) Ensure that the hospital works cooperatively with the

designated OPO, tissue bank and eye bank in educating staff on donation

issues, reviewing death records to improve identification of potential

donors, and maintaining potential donors while necessary testing and

placement of potential donated organs, tissues, and eyes take place.

(b) Standard: Organ transplantation responsibilities. (1) A

hospital in which organ transplants are performed must be a member of

the Organ Procurement and Transplantation Network (OPTN) established

and operated in accordance with section 372 of the Public Health

Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term

``rules of the OPTN'' means those rules provided for in regulations

issued by the Secretary in accordance with section 372 of the PHS Act

which are enforceable under 42 CFR 121.10. No hospital is considered to

be out of compliance with section 1138(a)(1)(B) of the Act, or with the

requirements of this paragraph, unless the Secretary has given the OPTN

formal notice that he or she approves the decision to exclude the

hospital from the OPTN and has notified the hospital in writing.

(2) For purposes of these standards, the term ``organ'' means a

human kidney, liver, heart, lung, or pancreas.

(3) If a hospital performs any type of transplants, it must provide

organ-transplant-related data, as requested by the OPTN, the Scientific

Registry, and the OPOs. The hospital must also provide such data

directly to the Department when requested by the Secretary.

(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare

Hospital Insurance; Program No. 93.778, Medical Assistance Program)

Dated: June 15, 1998.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.

Dated: June 16, 1998.

Donna E. Shalala,

Secretary.

[FR Doc. 98-16490 Filed 6-17-98; 10:12 am]

BILLING CODE 4120-01-P