Medicare and Medicaid Programs; Hospital Standard for Potentially HIV Infectious Blood and Blood Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 482

[BPD-633-F]

RIN 0938-AE40

Medicare and Medicaid Programs; Hospital Standard for Potentially

HIV Infectious Blood and Blood Products

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

ACTION: Final rule.

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SUMMARY: This final rule requires hospitals participating in the

Medicare and Medicaid programs to take appropriate action when the

hospitals learn that they have received whole blood, blood components

(including recovered plasma), source plasma, and source leukocytes

(hereafter referred to as blood or blood products) that are at

increased risk of transmitting Human Immunodeficiency Virus (HIV)

[[Page 47424]]

infection. If the hospital learns that it has received blood or blood

products collected from a donor recently exposed to HIV, before the

donor has a sufficient level of antibody to be detected by the

screening test for antibody to HIV, the hospital must quarantine any

blood or blood products remaining in inventory pending confirmatory

testing. If the presence of HIV is confirmed by more specific testing,

the hospital must notify patients who received the blood or blood

product.

This final rule is intended to ensure that proper health and safety

steps are taken to minimize further spread of HIV infection. A final

rule published elsewhere in this Federal Register by the Food and Drug

Administration applies the same requirements to entities furnishing

transfusion services that do not participate in the Medicare and

Medicaid programs and clarifies the responsibilities of blood

establishments to identify and notify the transfusion service that

received affected blood and blood products.

EFFECTIVE DATES: This rule is effective on November 8, 1996.

FOR FURTHER INFORMATION CONTACT: Janet Samen, (410) 786-9161.

SUPPLEMENTARY INFORMATION:

I. Background

Hospitals must meet certain conditions in order to participate in

the Medicare program. These conditions are intended to protect patient

health and safety and ensure that high-quality care is provided.

Hospitals receiving payment under Medicaid must meet the conditions for

participation in Medicare.

Regulations containing the Medicare conditions of participation for

hospitals are located in the Code of Federal Regulations at 42 CFR part

482, with the condition for hospital laboratory services at

Sec. 482.27. Section 482.27 contains general requirements for hospital

laboratories. The more detailed requirements for laboratories appear in

part 493, which sets forth requirements for all laboratories

participating in the Medicare, Medicaid, and Clinical Laboratories

Improvement Act (CLIA) programs.

In the Department of Health and Human Services, the Food and Drug

Administration (FDA) and HCFA are responsible for different aspects of

ensuring the safety of blood and blood products. Blood banks (referred

to as blood establishments in FDA regulations) are subject to the FDA

regulations for current good manufacturing practices and additional

standards for the manufacture of blood and blood components under 21

CFR parts 211 and 600, 601, 606, 610, and 640. Laboratories that

provide transfusion services are subject to CLIA requirements for

quality control and health and safety standards (42 CFR part 493,

subpart K) and laboratories in hospitals are also subject to the

hospital conditions of participation for adequacy of laboratory

services (Sec. 482.27). FDA and HCFA coordinate inspections of

hospital-based blood banks to minimize duplication of effort and reduce

the burden on affected facilities.

Human Immunodeficiency Virus (HIV) is a virus whose presence is

associated with Acquired Immune Deficiency Syndrome (AIDS). In response

to scientific data that show HIV is transmissible through infectious

blood and blood products, FDA has implemented an extensive system of

donor screening and testing procedures performed before, during, and

after a donation takes place to help prevent the transfusion of blood

and blood products that are infected with HIV.

Existing FDA regulations require each donation of blood to be

tested and found negative for the antibody to HIV and restrict the use,

for transfusion or further manufacture, of a donation testing

repeatedly reactive for the antibody to HIV. Repeatedly reactive means

that the initial HIV antibody screening test is reactive, retested in

duplicate, and one or both of the duplicate tests are reactive. As a

result of the FDA blood donor screening and testing procedures, the

risk of transmitting HIV infection through blood transfusion is very

low. However, despite the best practices of blood establishments, a

person may donate blood early in infection when the antibody to HIV is

not detectable by the screening test, but HIV is present in the donor's

blood (a so-called ``window'' period). If the donor attempts to donate

blood at a later date, the test for the antibody to HIV may at that

time be repeatedly reactive. Under such circumstances, previously

collected blood and blood products would be at increased risk for

transmitting HIV and a recipient of a blood product collected during

the ``window'' period would not know whether the donor was infected

with HIV at the time of the previous donation. Steps taken to identify

and quarantine remaining blood and blood products in storage and notify

recipients of the blood are known as ``lookback.''

As a result of advances in identifying the presence of HIV, the

``window'' period continues to shrink. The FDA final rule published

elsewhere in this Federal Register provides more information on the

length of the window period and discusses various diagnostic modalities

for HIV infection.

II. Proposed Regulations

FDA and HCFA published proposed regulations in the Federal Register

on June 30, 1993 (58 FR 34962 and 58 FR 34977, respectively) to require

lookback by blood establishments and transfusion services when it is

later determined that potentially HIV infectious blood or blood

products might have been collected and administered.

FDA proposed to require blood establishments (that is, facilities

involved in the manufacture of blood and blood components) to

quarantine previously collected blood and blood products collected from

a donor who tested negative at the time of a previous donation but

tests repeatedly reactive for the antibody to HIV on a later donation.

A donor would be considered to be infected by HIV if the results of the

FDA's licensed tests described at 21 CFR 610.45 show the presence of

the antibody to HIV and if the screening results are confirmed positive

by a licensed, more specific test. Blood establishments would be

required to promptly notify the hospital transfusion service of the

need to quarantine the potentially HIV infectious blood or blood

products that were distributed.

In the HCFA regulation, we proposed to add a new paragraph (c) to

Sec. 482.27 (``Conditions of participation: Laboratory services.'') to

set forth the standard for potentially HIV infectious blood and blood

products. Under the proposed rule, when the hospital learns that it has

administered blood that may have been collected during the ``window''

period, the hospital would be required to make several attempts to

notify the patient's attending physician (physician of record) and ask

the physician to inform the patient of the need for HIV testing and

counseling. If the physician is unavailable or declines to notify the

patient, the hospital must make several attempts to inform the patient

of the need for HIV testing and counseling. We proposed that the

notification include basic explanations to the patient and referral for

counseling and that the hospital document the notification or attempts

to notify the attending physician and the patient.

In addition, we proposed to require that, when services are

furnished to a hospital by an outside blood bank, there must be an

agreement governing the procurement, transfer, and availability of

blood and blood products specifying that the blood bank promptly notify

the hospital if potentially HIV infectious blood or blood products have

been made available to the hospital.

[[Page 47425]]

Notification would enable the hospital to take proper health and safety

steps to minimize further spread of HIV infection.

III. Analysis of and Responses to Public Comments

In response to the June 1993 HCFA proposed rule, we received 28

timely items of correspondence from national organizations, nurses,

hospital administrators, State offices, law firms, and various

organizations representing infection control officers and blood banks.

A summary of individual comments we received on the June 1993 proposed

rule, our responses, and the changes we have made are discussed below.

Coordination of FDA and HCFA Efforts

When HCFA and FDA published the June 1993 proposed rules, we

intended that all blood banks (that is, blood establishments involved

in the manufacture of blood and blood components) and transfusion

services (that is, consignees that receive blood and blood products

from blood banks/blood establishments and perform compatibility

testing) comply with the quarantine and patient notification

requirements. However, based on public comments received by both

agencies, it appears that there was public misunderstanding of the

mission of each agency and the scope of the rulemaking, as discussed

below.

Comment: One commenter indicated that terminology used by HCFA and

FDA is not consistent. In the FDA regulation, the terms ``consignees''

and ``transfusion services'' are used while the HCFA regulations refer

to ``hospitals'' and ``blood banks.'' The commenter requested more

consistent use of the terms. In addition, the commenter noted that the

term ``blood banks'' may refer to a transfusion service or a

freestanding community blood center. Finally, the commenter noted that

the term ``consignee'' may mean the facility providing the transfusion

service and that the term ``recipient'' may refer to the transfused

patient. The commenter asked that ``transfusion service'' and

``transfused patient'' be the preferred terms.

Response: While we agree that the use of different terms can be

confusing, we do not believe it would be appropriate to revise the

terminology used in the HCFA regulation because it is consistent with

that used elsewhere in title 42 of the Code of Federal Regulations,

including the hospital conditions of participation and the CLIA

regulations. Likewise, although the FDA terminology is different, it is

understood by the entities regulated by FDA and described by FDA as

follows.

A transfusion service is a facility that is part of either

a hospital or an independent clinical laboratory, that performs

compatibility tests, stores and distributes blood components, but is

not engaged in the routine collection or preparation of blood or plasma

except for therapeutic collections or separation of recovered plasma or

red blood cells.

A blood establishment is an FDA registered facility or

portion of a facility registered as such with FDA pursuant to 21 U.S.C.

section 510 and 21 CFR part 607 that manufactures blood or blood

products. These include hospital and non-hospital blood banks,

plasmapheresis centers, donor centers, and the laboratories performing

testing for these establishments.

To avoid confusion concerning whether FDA requirements regarding

lookback and quarantine apply to hospital transfusion services, we are

adding those requirements to the hospital conditions of participation.

We have added a paragraph (c)(3) to Sec. 482.27 to include the

following requirements:

Upon notification by the blood bank (blood establishment)

that certain blood and blood products are at increased risk for

transmitting HIV infection, the hospital (transfusion service) must

determine the disposition of the blood or blood product and if it is

holding any of the blood or blood product in inventory. If so, the

hospital must quarantine the blood or blood products until notified by

the blood bank of the results of an FDA-licensed, more specific test or

other followup testing recommended or required by FDA.

The hospital may release the blood or blood product from

quarantine only after notification by the blood bank that the

additional testing was negative for the HIV antibody, absent other

informative test results. If the testing confirms the presence of the

antibody for HIV, the hospital must dispose of the blood and blood

products in accordance with FDA regulations at 21 CFR 606.40 and notify

any patients who received the affected blood or blood products of the

need for HIV testing and counseling. (The FDA final regulation requires

the blood bank to complete the licensed, more specific test for the

antibody to HIV within 30 days and promptly notify the hospital

transfusion service of the test results.)

Comment: Several commenters suggested that any facility receiving

and administering blood or blood products be required to comply with

the same notification requirements as set forth in the proposed rule.

Two commenters also suggested this standard for ambulatory surgical

centers.

Response: When we published the proposed regulation, we

specifically requested public comment regarding the need to develop

similar requirements for other facilities that provide transfusion

services. Although we did not receive specific suggestions, we have

revised Sec. 482.27(c)(4) to clarify that when a hospital (transfusion

service) furnishes blood or blood products to another entity or

appropriate individual, the hospital retains responsibility for patient

notification.

We believe this approach is reasonable and consistent with the

usual path followed by blood from donation to transfusion. As clarified

in FDA regulations, blood establishments (defined in 21 CFR 607.3(c))

collect, screen, and test the blood, prepare blood components or

process blood for further manufacture, and label blood components for

distribution to a transfusion service. The transfusion service is the

entity responsible for determining compatibility with the patient's

sample and sending the blood to the patient's location (for example,

the hospital, clinic, nursing facility, or home setting). In order to

release the blood and blood products for transfusion, the hospital must

crossmatch the blood for compatibility with the patient's sample. In

doing so, the hospital would obtain enough information to enable them

to notify the patient. Thus, the hospital has patient information and a

notification system in place and is in the best position to perform

patient notification.

We note that FDA is adopting the patient notification requirements

for hospitals that do not participate in Medicare and Medicaid. Thus,

all hospitals that administer blood and blood products or release the

blood and blood products must comply with the same patient notification

requirements.

Timeframe for Completing Notification

In the proposed rule, we did not require a specific timeframe for

completion of the notification effort. Rather, we required the hospital

to make several attempts to notify the patient's attending physician

and, if the physician is unavailable or declines to notify, make

several attempts to notify the patient. We indicated in the preamble

that the hospital's notification effort should begin immediately after

receiving the information from the blood bank and be completed within 8

weeks. Although we specifically invited public comment on the

sufficiency of this level of effort, we did not receive enough

information to draw any

[[Page 47426]]

conclusions about existing patient notification activities. In

addition, the information we received indicated fundamental differences

in the viewpoints of the commenters as described below.

Comment: Two commenters agreed with the approach contained in the

proposed rule and did not want the hospital's search for the patient's

physician or the patient to be bound by a specific timeframe. One

commenter suggested that we only include the following requirements in

the final rule: (1) Require that hospitals have written procedures for

notifying patients; (2) provide for an appropriate, knowledgeable

person to talk with the patient if the physician cannot be reached or

chooses not to be involved; and (3) require that the notice be

expeditious and confidential and include recommendations to seek HIV

testing and counseling. Another commenter suggested that we require

only that the hospital exercise due diligence and document its

notification efforts.

Response: In order to respond to these commenters, we consulted

with FDA on the best approach to the notification timeframe. We have

decided to include a specific timeframe for completion of the

notification effort in order to prevent hospitals from making sporadic

efforts over a protracted period of time and to provide a reasonable

minimum standard (Sec. 482.27(c)(5)). We believe requiring at least

three attempts to notify the physician and, as necessary, three

attempts to notify the patient within 8 weeks is reasonable. Since

patient notification by the hospital rarely will be necessary, we do

not believe that requiring as many as six notification attempts will be

burdensome to hospitals.

Comment: One commenter asserted that the search could be performed

in less than 8 weeks depending on a hospital's ability to locate

records and contact the patient by mail. Still another commenter

questioned whether we had considered the possible delay in starting

treatment that may occur because of the 8-week period allowed for

notification and expressed concern that an 8-week delay could

contribute to individuals unknowingly transmitting HIV. One commenter

indicated that four or five attempts over a 3- to 5-day period would be

sufficient while another commenter suggested that we require a 12-week

timeframe based on their concern that the physician might decline at

the end of the 8 weeks and leave little time for the hospital to

perform the notification.

Response: We believe that most, if not all, notifications would be

accomplished with relatively little effort and that three attempts

should be sufficient in most cases. On the other hand, if a hospital

has made a good faith effort of at least three attempts but is not able

to locate the patient within 8 weeks, we do not expect the hospital to

continue its search. Of course, there is no limit on how much time a

hospital may choose to expend on this effort.

We do not intend for the hospital to use the entire 8 weeks to

attempt to locate a physician who, at the end of the 8-week period, may

be determined to be unavailable. Rather, we intend that the majority of

the 8 weeks be used to locate and notify the patient. We recommend that

the hospital promptly make three attempts within one week to notify the

physician. If the hospital is unable to locate the physician or the

physician does not agree to notify the patient, the hospital should

promptly start attempts to locate the patient.

In addition, it would be inappropriate for the physician to wait

until the end of the 8-week period to inform the hospital that he or

she is unwilling to notify the patient. In most cases, we believe that

the hospital will contact the physician by telephone and the physician

will make an immediate decision to agree or decline to notify the

patient. However, if the physician is not able to make an immediate

decision, the physician should indicate his or her decision within 1

week of the hospital's request. In this way, it is reasonable to expect

the hospital to locate and notify the patient in the remaining 7 weeks.

We are aware that there may be instances where the hospital's

notification efforts will extend beyond the 8-week period due to

circumstances beyond the hospital's control. For example, a physician

who agrees to notify the patient may later inform the hospital that he

or she was unable to notify the patient or the patient may not respond

timely to notification efforts because he or she is away from home. In

these cases, the hospital must document in the patient's medical record

the extenuating circumstances that prevented patient notification

within the 8-week timeframe (Sec. 482.27(c)(5)).

Comment: One commenter questioned whether patient notification is

necessary if several years have passed after receipt of a transfusion,

or whether the hospital can establish timeframes after which patient

notification need not be made.

Response: Section 610.46(a) of the FDA regulation published

elsewhere in this Federal Register defines the quarantine and

notification process to be followed by blood establishments supplying

blood to hospitals. Under this rule, when a blood establishment learns

of a change in the HIV status of a donor, the blood establishment must

determine if any prior donations meet the quarantine and notification

requirements set forth in 21 CFR 610.46(a) and, as appropriate, inform

the hospital(s) that received any prior donations from the donor. Once

the blood establishment notifies the hospital(s), we do not believe

that there is ever a time that patient notification need not be

attempted. It is only when the physician or the hospital cannot locate

the patient that the process may come to an end.

Role of the Physician in the Notification Process

Comment: One commenter suggested that we require any physician who

wishes to participate in the Medicare or Medicaid program to assume the

responsibility for notifying the patient and providing or making

available appropriate HIV counseling to the patient. Another commenter

requested that we indicate the consequences for physicians who fail to

notify the patient.

Response: Although we believe that it is appropriate for attending

physicians to notify their patients, we do not have authority under

current law to require that physicians do so. Thus, while it is true

that there are no Federal penalties imposed on physicians who decline

or do not take appropriate steps to notify the patient, we believe most

physicians will choose to notify the patient and voluntarily inform the

hospital whether notification occurred. Since we have an agreement with

each Medicare and Medicaid participating hospital and the law

authorizes us to include provisions such as these under the hospital

conditions of participation, we have determined that if the physician

does not agree to notify the patient, the hospital must assume

responsibility for patient notification.

Comment: Several commenters wanted clarification regarding when a

physician could decline to notify the patient. Many commenters

disagreed with permitting the physician the option to decline

notification. Four commenters stated that this policy contradicts

principles of continuity of care and sound medical practice. One

commenter asserted that no physician will notify patients if given the

option and that the requirement for hospitals to notify patients when

physicians decline removes any incentive for the physicians to

participate in the notification process.

Response: In the interest of continuity of care and sound medical

practice, we believe that most physicians will notify

[[Page 47427]]

their patients. However, we continue to believe there could be

legitimate reasons why a physician might refuse to notify the patient;

for example, the physician determines that the patient has moved to

another State and it would be difficult for the physician to identify

HIV counseling and testing programs in the patient's new location, or

the physician has had very limited or no contact with the patient in

several years.

Comment: Several commenters asked us to publish a definition of

``attending physician'' to clarify who should be responsible for

patient notification.

Response: In Sec. 482.27(c)(4), we have included the phrase

``physician of record'' in parentheses next to the term ``attending

physician.'' Although many physicians may have contact with a patient

in the course of a hospital stay, the admitting physician is identified

on the admission form. We believe that this physician is the

``physician of record'' and should be responsible for the notification.

However, if the physician who orders the transfusion is not the same

physician as the physician identified on the admitting form, the

hospital may ask either physician to perform the notification.

Comment: One commenter questioned the role the hospital plays in

determining whether a physician provided information and referred the

patient for counseling. One commenter asked that we specify whether the

hospital is obligated to complete any part of the notification that the

physician fails to carry out. Additionally, the commenter questioned

how the hospital would know what the physician had done.

Response: Under this regulation, when the physician accepts

responsibility for the notification, the hospital is not required to

follow up with the physician to determine whether patient notification

occurred. Since the hospital may not be aware of the information the

physician provides, we cannot require that the hospital complete the

notification. In light of physicians' professional relationship with

hospitals, we believe physicians will inform the hospital whether

notification occurred. If the physician informs the hospital that he or

she was unable to notify the patient, the hospital must proceed with

patient notification.

Comment: One commenter wanted to know at what point the hospital

resumes responsibility for notification if the physician is unable to

contact the patient. Two commenters questioned whether the physician is

required to inform the hospital of the results of notification, for

example, whether the physician was unable to locate the patient,

whether the patient was tested, and the results of the testing.

Response: Although we believe that the physician, as part of his or

her professional responsibility, will inform the hospital of the

results of notification, he or she is not required to do so. If the

physician accepts responsibility for notification, and later informs

the hospital that the patient was not notified, the hospital must

attempt notification, regardless of the time that elapsed after the

hospital first notified the physician.

Some State or local health groups may require further followup and

other epidemiological information but release of information is

dependent upon State and local laws, the medical practice, and the

patient-physician relationship. Finally, having the physician notify

the hospital of the results of testing of the referred patient is

outside the scope of the notification requirements of this regulation.

Comment: One commenter noted that the laws in his State require the

physician to provide information to the patient regarding blood

products in advance of any non-emergency transfusion and, when the

physician orders an HIV test, to obtain the patient's informed consent.

Response: While these precautions are indeed important to the risk

management of blood and blood products, they do not remove the need for

notification by the hospital or physician of possible contamination.

Comment: One commenter indicated that assigning patient

notification responsibility to the hospital means that a clinician must

be identified to handle the cases declined by the physician. Several

commenters questioned whether the appropriate individual to notify the

patient should be limited to someone with medical experience or whether

the hospital may designate any nonmedical personnel to perform these

notifications. One commenter indicated that the physician is the only

individual who should notify the patient, while another commenter noted

that the infection control representative in his facility is

responsible for notification. Another commenter requested that we

permit the hospital to bypass the doctor/patient relationship if the

physician resists the hospital's request to notify the patient. One

commenter suggested that when the physician declines to notify the

patient, the hospital should use the mail system, rather than have a

hospital employee unknown to the patient, to provide the notification.

Response: We continue to believe it is preferable that notification

be made by a physician with whom the patient has a professional

relationship, such as the attending physician who coordinated the care

during the patient's hospitalization or the physician who ordered the

blood or blood product. Nevertheless, the hospital may designate

another physician or an appropriate hospital representative to inform

the patient. We believe that the hospital in its policies and practices

will designate an appropriate, competent individual to perform this

type of notification such as an infection control officer, a nurse, a

clinical laboratory scientist, an individual with medical expertise who

is not a physician, or a social worker. We note that the hospital must

review any voluntary notification procedures to ensure that they

conform to the requirements of this regulation.

Comment: Several commenters indicated that hospitals should develop

policies to identify the appropriate physician to assist in

notification and counseling, in the event efforts to locate the

attending physician are unsuccessful.

Response: We have revised the regulation to require hospitals to

establish policies and procedures for notification (Sec. 482.27(c)(6)).

The final regulation does not require a hospital to provide HIV testing

or counseling, but merely to refer the patient for testing and

counseling. We expect that the referral for testing and counseling will

be made to a physician or organization that provides high quality HIV

testing and has extensive experience in providing HIV counseling.

Notification Requirements

Comment: We invited comment on whether our proposed rule should be

implemented as part of a Medicare hospital standard or as part of the

FDA requirements applicable to blood establishments. While most

commenters indicated that hospitals, not blood banks, should be

responsible for assuring that patients are properly notified of the

possibility that they have received infectious blood, some commenters

recommended that blood banks should be required to make notification.

Response: Based on the comments we received, we have determined

that the hospital could best perform the notifications since it has

access to medical records. Blood banks that are not departments of

hospitals do not routinely receive hospital patient information. If the

blood bank were a department within the hospital or performed

compatibility testing for the hospital, it would have access to patient

information and could perform the

[[Page 47428]]

notification as designated by hospital policy. Under this final

regulation, blood banks must notify the hospital of receipt of

potentially HIV infectious blood and blood products and hospitals are

responsible for patient notification.

Comment: Two commenters recommended that specific operational

issues should be developed at the hospital level within general

guidelines established by regulation. Another commenter suggested that

the regulation describe what hospitals are expected to accomplish and

let hospitals determine, based on their own experience and

circumstances, how best to notify patients. However, two others

requested that the mechanics of notification be spelled out for

standardization.

Response: As noted previously, we added Sec. 482.27 (c)(4) and

(c)(5) to require three attempts to notify the physician, and, as

necessary, three attempts to notify the patient with 8 weeks. We

believe that, within these parameters, the hospital retains flexibility

to develop its own policies and procedures in order to meet the

notification requirements.

Comment: One commenter indicated that the language of proposed

Sec. 482.27(c)(2) is inconsistent with the preamble because it implies

that the hospital is obligated to notify both the physician and the

patient.

Response: We are clarifying in this final rule that the hospital

must notify the patient only if the physician is unavailable, declines,

or later informs the hospital that he or she was unable to notify the

patient (Sec. 482.27(c)(4)).

Comment: One commenter indicated that a search should be terminated

only after a review is conducted by a hospital-sponsored ``lookback

advisory committee'' composed of relevant specialists and expert staff

members.

Response: While we support the use of an advisory committee to

determine when it is appropriate for patient notification efforts to

cease, we have decided not to adopt this suggestion in the regulation.

We would prefer to allow a hospital flexibility to develop responsible

policies and procedures. Of course, a hospital may choose to

incorporate the commenter's suggested approach into its policies and

procedures.

Comment: Four commenters indicated that there are no requirements

that identify the information to be released during patient

notification. The commenters suggested that we establish uniform and

standard minimum requirements for disclosing information to patients

during the notification process.

Response: We agree and have added Sec. 482.27(c)(6)(iii) to clarify

that when a physician or hospital notifies a patient about the need for

HIV testing and counseling, the patient will also be given the names of

several programs or places in the area where the patient resides that

provide these services. In addition, the patient will be told about any

requirements or restrictions the programs may impose such as whether

the program requires a fee, a physician request form, identification or

public assistance cards, or a residency requirement. In some

situations, the hospital, in conjunction with its advisory groups, will

provide the materials for the physician to use or identify programs

that provide the HIV testing and counseling. Some groups have developed

packages of materials, brochures, and information about the risks of

blood and blood products and how HIV infection is transmitted. The

Centers for Disease Control and Prevention (CDC) National AIDS Hotline

operates a toll-free number (1-800-342-2437) 24 hours a day that the

hospital or physician can give to the patient for more assistance. (The

Hotline offers anonymous, confidential AIDS information to the American

public. Trained information specialists answer questions about HIV

infection and AIDS. The physician or hospital can give the patient the

Hotline number (1-800-342-AIDS/2437 (English); 1-800-344-7432 (Spanish)

and 1-800-243-7889 (TDD/Deaf Access)). We encourage physicians and

hospitals to make available to the patient any additional information

that would be useful to the patient and consult with and obtain

resource materials from programs that are funded by the Ryan White

Comprehensive AIDS Resources Emergency Act, the CDC, county and State

health departments, and AIDS awareness groups.

Privacy and Recordkeeping

Comment: One commenter expressed concern that the proposed

regulation did not address the issue of privacy in recordkeeping,

including access to the information from the Blood Donor Locator

Service (BDLS) operated by the Social Security Administration (SSA),

and blood bank and hospital records. The commenter suggested that, even

though these issues may be addressed elsewhere, they needed to be

restated in this regulation.

Response: Hospital requirements for confidentiality in

recordkeeping are already in existing regulations at Sec. 482.24.

Documents related to notification become part of the patient's medical

record and are subject to the normal safeguards for access, information

release, patient consent, and other precautions for confidential

information, whether in hard copies, films, or computer records. If

there is any doubt about confidentiality or disclosure, a medical

record administrator can be consulted to provide adequate instructions.

In addition, the hospital must establish procedures that conform to all

Federal, State and local laws regarding confidentiality.

Comment: One commenter suggested that the hospital send the

physician a return postcard and ask that the postcard be sent back to

the hospital indicating whether the patient was notified, and, if so,

the date the physician notified the patient.

Response: As noted earlier, we have revised the regulation to

require hospitals to establish policies and procedures for

notification, including requirements for confidentiality

(Sec. 482.27(c)(7)). We have concerns about maintaining patient

confidentiality through use of postcards to convey information about

potentially HIV infectious blood and blood products. Although this

final rule affords the hospital the flexibility to establish policies

and procedures for the notification process, the policies and

procedures must protect patient confidentiality.

Comment: In addition to any State requirements or laws concerning

HIV confidentiality, many commenters recommended that all written

patient notifications be marked ``confidential'' and be sent only by

certified mail. Two commenters asked for a ``return receipt.''

Response: While we would support efforts by hospitals to use

certified mail when written patient notification is necessary, we have

decided not to incorporate this requirement in the regulation.

Similarly, although use of a return receipt would provide the hospital

with confirmation that the individual received the information,

incorporating this specific requirement may conflict with State laws

that require ``marking for confidentiality'' and would limit the

hospital's flexibility to develop a process based on its experience and

circumstances.

Comment: One commenter did not want all patients notified based on

a concern that once a patient's HIV status is known, the patient may be

subjected to ostracism and discrimination in receiving care. Since many

hospitals use universal precautions for infection control, the

commenter believed that there is no need to know the HIV status of

patients. However, information about

[[Page 47429]]

the HIV status could be retained by the patient's physician.

Response: We believe it is important for the patient to know of his

or her potential exposure to HIV so that he or she will be informed of

the need for testing and counseling in order to promote behavior

changes that will reduce the risk for transmission of HIV and to detect

HIV infection in persons so that their need for medical treatment and

other services can be assessed.

Comment: One commenter recommended that we clarify the

documentation needed to be filed by the attending physician and

materials to be developed and retained by the hospital. Another

commenter wanted to know which steps in the process should be

documented, that is, the attempts to notify patients, counseling,

patient referral, etc. One commenter questioned whether compliance can

be evaluated by Medicare, the FDA, or the Joint Commission on

Accreditation of Healthcare Organizations (JCAHO) without specific

documentation requirements for notifying patients of potentially

infectious blood or blood products.

Response: We are not looking for lengthy documentation, but

sufficient recordkeeping that indicates when attempts were made to

notify the patient and the results of those attempts. We are not

prescribing forms that a hospital must use; however, a hospital may

develop its own record forms. We do not believe that additional files

or new systems of data should be kept on this matter. The surveyor, in

determining compliance, must be able to determine satisfactorily that

the manner in which the hospital performs notifications comports with

the regulation.

Comment: One commenter requested that we clarify the type of

information regarding the patient, for example, patient testing

results, that can be shared between physician and hospital.

Response: The hospital and the physician may determine if any

information should be shared. This rule does not require the sharing of

information between the physician and the hospital. Patient testing

results are outside the scope of this regulation.

Comment: One commenter asked for standardized recommendations for

record retention by blood banks and by institutions accepting and

administering blood and blood products. The commenter asserted that his

facility requires that employee health records be kept for 30 years

after terminating employment.

Response: Although a facility may require that employee health

records be kept for 30 years after the employee leaves employment, this

is not the current Federal standard for records involving blood and

blood products. The hospital conditions of participation require that

hospital medical records must be kept at least 5 years

(Sec. 482.24(b)(1)). The notification records and blood bank records

are subject to the same 5-year requirement. Additionally, the FDA

regulations at 21 CFR 606.160(d) require that blood and blood product

records be kept for at least 5 years after processing, or 6 months

after the latest expiration date, whichever is later. Under CLIA, the

laboratory regulations on quality control records for blood and blood

products (Sec. 493.1221) reflect the FDA regulation. Any longer

timeframe for retention of medical records is dependent upon hospital

policies, State laws, computerization, storage space, and

investigational studies.

Comment: Two commenters interpreted the proposed rule as requiring

notification by the hospital when the patient is terminally ill,

debilitated, or celibate, and is not (and has not been) an infection

risk to others. The commenters expressed concern that these patients

would be adversely affected by the notification. The commenter

interpreted the proposed rule to require the hospital to inform the

patient even if the physician caring for the patient, either alone or

in consultation with relatives, believes the harmful effects of

notification exceed the benefits of notification.

Response: We have revised the regulation at Sec. 482.27(c)(8) to

clarify that the physician or hospital may notify a legal

representative designated in accordance with State law. Further, if the

patient is competent, but the physician believes the information should

not be given to the patient and State law permits a legal

representative or relative to receive information on the patient's

behalf (for example, when the patient is under age 18), then the

physician must notify the patient's representative or relative. Upon

learning of the death of a transfusion patient, the hospital must

pursue the notification process to inform the patient's family. Public

health concerns would warrant that the notification process continue

and include the deceased patient's legal representative or relative. It

would not be appropriate for a physician or hospital to determine that

the patient or someone acting on his or her behalf need not be

informed.

Comment: Three commenters wanted epidemiologic information,

demographics, or other information to be provided to the State health

department or other appropriate entity for patient followup. Another

commenter requested that the blood bank notify the physician and the

regional health departments about potentially HIV infectious blood and

blood products being administered. The commenter referred to the health

department's ability to track various diseases and to provide pre- and

post- counseling of possible HIV-infected individuals.

Response: Disclosure of information to entities other than the

hospital, the patient, and, as appropriate, the patient's legal

representative or relative, is governed by State law and hospital

policies and is outside the scope of this rulemaking.

Comment: One commenter suggested that the notification about a

patient's HIV status be given to good samaritan bystanders. The

commenter stated that there are circumstances when an individual

injured in an accident or fire requires subsequent medical care. When

that care is given and the patient is found to be HIV positive, the

commenter stated that all those who have given the patient medical care

should be informed of the patient's status. The commenter wants State

and Federal regulations to protect health care workers, emergency

medical technicians, and public safety officials.

Response: The comment, while addressing an important public health

and safety issue, is beyond the scope of this regulation. However, the

CDC published a final rule on March 21, 1994 to address this issue (59

FR 13418).

Comment: One commenter wanted the hospital to be informed promptly

by outside blood sources if there is any doubt about its blood supplies

possibly being infected by the HIV virus.

Response: The issue raised by the commenter is addressed in the FDA

final regulation published elsewhere in this Federal Register.

Hospital Agreements With Blood Banks

Comment: One commenter indicated that government intrusion in

mandating agreements between hospitals and blood banks would not permit

the organizations to work out their own agreements. Another commenter

stated that if hospitals are required by regulation to have an

agreement for procurement, transfer, and availability of blood and

blood products, the blood banks would be in a position to impose

additional terms through the agreements that the hospital would not

otherwise wish to accept, for example, an agreement under which a

hospital would never seek indemnification from the blood bank for

infectious blood or

[[Page 47430]]

blood products. Another commenter suggested that his facility

occasionally obtains blood or blood products from a source other than

the blood bank that regularly supplies it. The commenter questioned

whether the hospital is required to have an agreement with all sources

supplying blood to the hospital.

Response: The laboratory requirements at Sec. 493.1277 already

require that in the case of services regularly furnished by an outside

blood bank, the hospital laboratory must have an agreement reviewed and

approved by the director that governs the procurement, transfer, and

availability of blood and blood products. We note that a blood bank

that is part of a hospital is not required to have an agreement with

the hospital administration, but the laboratory still would have

policies of proper practice that meet the FDA regulations and

requirements of other regulatory and accrediting bodies. We intend that

the details of the agreements or practice policies that are worked out

between the blood bank and the hospital be consistent with Federal,

State and local laws. Finally, we recognize that, under certain

circumstances, hospitals may receive blood from a source other than the

blood bank that has an agreement with the hospital. For example, during

a blood emergency, a hospital may receive blood from another blood bank

that may have a surplus of a special blood type that is needed by the

hospital's patient. In this situation, if the blood bank becomes aware

that the blood it furnished the hospital is potentially infected with

HIV, the FDA regulations require the blood bank to notify the hospital.

Comment: One commenter indicated that the blood bank obligations

are better achieved through regulations by the FDA. Further, the

commenter suggested that since requirements change from time to time,

all agreements would need to be changed every time. The commenter also

concluded that establishing requirements by regulation alone is more

flexible and efficient than regulations and contractual agreements.

Response: As noted previously, FDA and HCFA are responsible for

different aspects of ensuring the safety of blood and blood products.

Blood banks are subject to FDA regulations for current good

manufacturing practices and additional standards for the manufacture of

blood and blood components under 21 CFR parts 211 and 600, 601, 606,

610, and 640. HCFA regulations cover quality control, health and safety

issues, and adequacy of laboratory services. Since the hospital has

access to medical records and it is preferable that the notification is

made by an individual with whom the patient has a professional

relationship, such as the attending physician who coordinated the care

during the patient's hospitalization, we believe that the requirements

of this regulation should be addressed through the hospital conditions

of participation. Agreements can be written flexibly so that any

changes in FDA or HCFA requirements can be incorporated into operating

procedures rather than by constructing a new contractual agreement.

Comment: One commenter recommended that the SSA BDLS be expanded

and adapted to provide assistance in mandated lookback programs to

locate patients. Another commenter asked that the SSA BDLS program be

available for locating the last address of known sexual partners of

lookback patients if notifying them is determined to be necessary.

Response: The SSA BDLS was implemented to enable States and

authorized blood donation facilities to notify blood donors whose

donations indicate that they are or may be infected with HIV. Section

8008 of the Technical and Miscellaneous Revenue Act of 1988 (Pub. L.

100-647) provides for furnishing only to participating States and

authorized blood donation facilities at their request the last known

personal mailing address of blood donors whose blood donation shows

that they are or may be infected with HIV, if the State or authorized

blood donation facility has been unable to locate the donors. The SSA

BDLS cannot be used for any other purpose. To expand the program to

include obtaining information on the patient or known sexual partner

would require a legislative amendment.

Comment: One commenter stated that the rule did not address

requirements for hospitals that have their own blood banks.

Response: We have clarified in Sec. 482.27(c)(4) that if the

hospital has administered potentially HIV infectious blood and blood

products directly through its own blood bank or under an agreement with

an outside blood bank, the hospital must promptly notify the patient's

physician. We note that a hospital transfusion service that also

functions as a blood establishment, that is, collects and manufactures

blood and blood products, is subject to HCFA's final rule as a

transfusion service and FDA's final rule as a blood establishment.

Contracting for Notification

Comment: Four commenters recommended that we permit a hospital to

formally contract with a blood center to supervise the notification of

the patient, testing, and counseling procedures, if the physician is

unavailable or declines to do so. One commenter mentioned that the

departments of health in three States perform notification and tracing

of HIV/AIDS patients and contacts. Another commenter suggested public

health departments as an alternative for notification and counseling

because of the expertise and mechanisms that are already in place.

Response: There is no barrier to a hospital contracting with

another organization to perform the notification, testing, and

counseling. However, under this rule, the hospital is responsible for

the notification and referral. We are aware that a number of State

departments of health provide notification and tracing of HIV/AIDS

patients and contacts. Nonetheless, we continue to believe that the

hospital and the physician are in a better position to perform the

notification because of their prior involvement with the patient. A

hospital that delegates notification must ensure that the notification

and referral for counseling are performed in accordance with this

regulation. If the blood center or organization fails to comply with

the conditions of participation, the hospital would be subject to a

noncompliance action.

Counseling

Comment: Two commenters stated that some State laws require

specific counseling procedures and clinical information for those

undergoing counseling for HIV testing.

Response: We believe individual State laws should be followed to

provide information and counseling procedures following the

notification process. The notification and referral requirements in the

rule do not conflict with any such State laws.

Enforcement

Comment: One commenter urged us to recognize the Joint Commission

on Accreditation of Healthcare Organizations (JCAHO) and the American

Osteopathic Association (AOA) standards to avoid a second survey by

Medicare.

Response: We have been in contact with the JCAHO and AOA and have

evaluated their standards to ensure comparability with the requirements

in this final regulation. Both organizations plan to incorporate the

new requirements into the 1996 update to their accreditation standards.

Therefore, a hospital accredited by the JCAHO or the AOA would be

deemed to meet the Medicare requirement for the standards

[[Page 47431]]

on potentially HIV infectious blood and blood products. A second survey

by HCFA would not be routinely required. However, if a complaint was

filed regarding a look-back situation and HCFA decided the situation

warranted an investigation, HCFA may authorize a complaint

investigation.

Burden on Hospitals

Comment: One commenter disputed the estimate in the proposed rule

of 1 hour of public reporting burden (58 FR 34980) and suggested that

notification takes more than 1 hour to complete.

Response: We estimated the 1-hour timeframe based on several

assumptions: (1) The records on the patient had already been retrieved,

(2) the physician of record was noted on the admission sheet, and (3)

the hospital had the physician's correct phone number or address. We

anticipated that the phone conversation between the hospital

representative and physician would last approximately 10 minutes. We

inflated this figure to 1 hour because we wanted to include any time

necessary for recalls and wrong numbers. We also considered time

necessary for preparation of written notices and delivery of notices to

the mail room. We expect that a hospital will rarely need to notify a

patient directly, although we recognize that it would take additional

time. We did not receive any comments that cited examples of the time

involved to notify a patient. Some hospitals have computer linkup

between departments and can easily retrieve information. The time

involved for each case also may differ depending upon whether it was a

single unit of blood given to one patient versus a unit of blood that

was separated into several blood products and given to several

patients. If a single unit of blood is separated into several

components or blood products, each individual affected by the donor

represents a separate notification case.

Comment: Two commenters stated that the cost associated with an

additional standard would add an unnecessary regulatory burden.

Response: We disagree that the cost of this standard would be

burdensome. Although initial implementation of notification procedures

will require some expenditure of time and effort, we believe most

hospitals, blood banks, and physicians are currently voluntarily

complying with the requirements of this final regulation. We estimate

that the ongoing cost of complying with this regulation will be small

because the risk of a person being transfused with potentially HIV

infectious blood and blood products is small and declining.

IV. Provisions of the Final Regulations

After consideration of the public comments, we are adopting the

June 1993 proposed rule with the following changes.

We have clarified that when the blood bank notifies the

hospital that certain blood and blood products are at increased risk

for HIV infection, the hospital must determine if it is holding any of

the blood or blood product in inventory. If so, the hospital must

quarantine the blood or blood products until notified by the blood bank

of the results of a licensed, more specific test or other followup

testing recommended or required by FDA. The hospital may release the

blood or blood product from quarantine only after notification by the

blood bank that the licensed, more specific test was negative for HIV

antibody, absent other informative test results. (Sec. 482.27(c)(3))

We have clarified that when patient notification is

necessary, hospitals are required to make three attempts to notify the

patient's attending physician or the physician who ordered the blood or

blood product and ask the physician to notify the patient. If the

physician is unavailable, declines, or later informs the hospital that

he or she was unable to notify the patient, the hospital must make

three attempts to notify the patient. (Sec. 482.27(c)(4)

We have clarified that when a hospital releases blood and

blood products to another entity or appropriate individual for

transfusion, the hospital is responsible for the patient notification

process. (Sec. 482.27(c)(4))

We have specified that notification to a legal

representative or relative of the patient may be appropriate in those

instances permitted by State law or where the patient is deceased.

(Sec. 482.27(c)(8))

We have clarified that we are not requiring the physician

to make the actual counseling appointment for the patient and expanded

the description of the content of notification. (Sec. 482.27(c)(6)(ii)

and (iii))

We have clarified that a hospital's steps to notify must

be initiated promptly and completed within 8 weeks.

(Secs. 482.27(c)(4)(i) and (c)(5))

We have required that hospitals establish policies and

procedures for notification and documentation that conform to Federal,

State, and local laws, including requirements for confidentiality and

for medical records. (Sec. 482.27(c)(7))

We clarified that, if the hospital uses the services of an

outside blood bank, the agreement governing the procurement, transfer,

and availability of blood and blood products must require the blood

bank to promptly notify the hospital about potentially HIV infectious

blood and blood products. (Sec. 482.27(c)(2))

V. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.),

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 approval. In order to fairly evaluate whether an

information collection should be approved by OMB, 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.

Since this final rule contains information collections that are

subject to OMB review under the Paperwork Reduction Act of 1995, we are

soliciting public comment on these information collections as discussed

below.

As discussed in detail section III. of this preamble, we are

requiring in Sec. 482.27(c) that Medicare participating hospitals

undertake certain activities when they learn that they have received

blood or blood products that are at increased risk of transmitting HIV

infection. These activities include the identification and quarantine

of affected blood and blood products that remain in inventory pending

confirmatory testing. If the testing confirms that blood or blood

products the hospital received are potentially HIV infectious, the

hospital must promptly make at least three attempts to notify the

patient's attending physician and ask the physician to inform the

patient of the need for HIV testing and counseling. If the physician is

unavailable, declines, or later informs the hospital that he or she was

unable to notify the patient, the hospital must promptly make at least

three attempts to notify the patient, the patient's surviving relative,

or other person designated in accordance with State law. The hospital

must document in the patient's medical record the notification

[[Page 47432]]

or attempts to give the required notification. Hospitals must establish

policies and procedures for patient notification and documentation that

conform to Federal, State, and local laws, including requirements for

confidentiality. Finally, if the hospital uses the services of an

outside blood bank, the agreement governing procurement, transfer, and

availability of blood and blood products must be revised to require the

blood bank to promptly notify the hospital about potentially HIV-

infectious blood or blood products. We note that the burden associated

with these requirements involves the establishment of a system to

facilitate information collection (that is, the notification and

documentation of notification), but are not themselves information

collections.

These changes would not increase significantly the paperwork and

information collection burden on the approximately 6,400 Medicare-

participating hospitals. We estimate that development of policies and

procedures for handling potentially HIV-infectious blood and blood

products and revision of agreements between hospitals and their blood

banks will increase each hospital's recordkeeping burden by

approximately 2 hours. Since this 2 hour burden is a one-time

occurrence for each hospital, the total burden associated with this

particular requirement is 12,800 hours.

We further estimate that notifying patients and documenting

notification efforts in patients' medical records will take

approximately 1 hour per occurrence. As indicated in section III. of

this preamble, we based this estimate on several assumptions: (1) The

records on the patient had already been retrieved; (2) the physician of

record was noted on the admission sheet; and (3) the hospital had the

physician's correct telephone number or address. The time involved for

each lookback case also may differ depending upon whether it was a

single unit of blood given to one patient versus a unit of blood that

was separated into several blood products and given to several

patients. We considered each individual affected by the donor to be a

separate notification case. FDA has estimated that approximately 60

lookback cases occur annually, with 16 involving patient notification.

These cases are spread over approximately 6,600 hospitals, including

approximately 200 hospitals that do not participate in the Medicare

program. If we assume that all 16 cases involving patient notification

were to occur in Medicare-participating hospitals, this requirement

would increase the recordkeeping burden on these hospitals by a total

of 16 hours.

The total paperwork and reporting burden on Medicare participating

hospitals as a result of the information collection requirements in

this rule is, therefore, estimated to be 12,816 (12,800+16) hours.

Organizations and individuals were given an opportunity to comment

on these information collection requirements at the time the June 30,

1993 rule was published. However, because of the new estimate of the

two-hour recordkeeping burden on hospitals resulting from the need to

establish policies and procedures and to amend agreements with blood

banks, we are again soliciting public comment on these information

collection requirements and providing the 60-day notice. As also stated

in the June 30, 1993 rule, a document will be published in the Federal

Register after Office of Management and Budget approval is obtained.

Organizations and individuals desiring to submit comments on these

information collection and recordkeeping requirements should send them

to HCFA, OFHR, MPAS, C2-26-17, 7500 Security Boulevard, Baltimore,

Maryland 21244-1850.

VI. Regulatory Impact Statement

Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612), 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

consider hospitals, blood banks, and physicians to be small entities.

In addition, 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. This

analysis must conform to the provisions of section 604 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.

This final rule expands the scope of the notification requirements

to include hospitals that release blood and blood products to another

entity or appropriate individual. Physicians will be asked to inform

the recipient of a potentially HIV infectious blood or blood product of

the need for HIV testing and counseling. If the physician is

unavailable, declines, or informs the hospital that he or she was

unable to notify the patient, the hospital is responsible for

notification. It also requires hospitals to quarantine blood or blood

products collected during the ``window'' period pending completion of

more specific testing.

The most recent estimates of the current HIV risk per unit is 1 in

420,000. These estimates are a dramatic improvement over the 1 in 487

odds that prevailed before HIV testing of the blood supply began in

1985. Appropriate efforts to further reduce the risk have occurred by

public education, improved tests, donor questionnaires, and revised

criteria for donor self-referral. However, it remains possible, despite

the best practices of a blood bank, that a person might donate blood

and blood products early in infection during the ``window'' period, the

time it takes a recently infected person to develop the antibodies that

screening tests are designed to detect. That window period is estimated

to range from a few weeks to 6 months. Section 482.24 (``Condition of

participation: Medical record services.'') currently requires hospitals

to maintain records for a period of 5 years. We expect hospitals will

identify recipients of blood and blood products and meet the

requirements of this rule to the extent the hospitals have records that

permit them to do so.

As for ongoing activities, we anticipate that only a small number

of cases per year can be traced to potentially HIV infectious blood and

blood products, and thus, we do not expect these final regulations will

result in a substantial economic or resource burden on small entities.

In addition, since most hospitals, blood banks, and physicians are

currently voluntarily complying with the requirements of these final

regulations, the ramifications of these final regulations are not

expected to be substantial. Because of the small number of cases

detected, individual hospitals will be required to quarantine blood and

blood products and notify blood recipients in only a few, if any,

cases. Nevertheless, the policies and procedures must be written and

periodically updated to ensure that appropriate and timely quarantine

and patient notification take place. Though not significant, there will

be an additional burden of time and resources on hospitals not

currently involved in the notification process.

We believe the ongoing cost of notification after implementation of

this regulation will not be significant or burdensome because the risk

of a person being transfused with potentially HIV infectious blood and

blood products is declining. Even though this final rule will affect

few people per year, it is

[[Page 47433]]

important that we ensure that potentially infected people are notified

so they may seek appropriate medical care or consider behavior changes

so as not to infect others.

Therefore, we are not preparing analyses for either the RFA or

small rural hospitals since we have determined, and we certify, that

this final rule will not likely have a significant economic impact on a

substantial number of small entities or have a significant impact on

the operations of a substantial number of small rural hospitals.

In accordance with the provisions of Executive Order 12866, this

regulation was not reviewed by the Office of Management and Budget.

Under the provisions of Public Law 104-121, we have determined that

this final rule is not a major rule.

List of Subjects in 42 CFR Part 482

Grant programs--health, Hospitals, Medicaid, Medicare, Reporting

and recordkeeping requirements.

42 CFR part 482 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).

Subpart C--Basic Hospital Functions

2. Section 482.27 is amended by adding a new paragraph (c) to read

as follows:

Sec. 482.27 Condition of participation: Laboratory services.

* * * * *

(c) Standard: Potentially infectious blood and blood products--(1)

Potentially HIV infectious blood and blood products are prior

collections from a donor who tested negative at the time of donation

but tests repeatedly reactive for the antibody to the human

immunodeficiency virus (HIV) on a later donation, and the FDA-licensed,

more specific test or other followup testing recommended or required by

FDA is positive and the timing of seroconversion cannot be precisely

estimated.

(2) Services furnished by an outside blood bank. If a hospital

regularly uses the services of an outside blood bank, it must have an

agreement with the blood bank that governs the procurement, transfer,

and availability of blood and blood products. The agreement must

require that the blood bank promptly notify the hospital of the

following:

(i) If it supplied blood and blood products collected from a donor

who tested negative at the time of donation but tests repeatedly

reactive for the antibody to HIV on a later donation; and

(ii) The results of the FDA-licensed, more specific test or other

followup testing recommended or required by FDA completed within 30

calendar days after the donor's repeatedly reactive screening test.

(FDA regulations concerning HIV testing and lookback procedures are set

forth at 21 CFR 610.45-et seq.)

(3) Quarantine of blood and blood products pending completion of

testing. If the blood bank notifies the hospital of the repeatedly

reactive HIV screening test results as required by paragraph (c)(2)(i)

of this section, the hospital must determine the disposition of the

blood or blood product and quarantine all blood and blood products from

previous donations in inventory.

(i) If the blood bank notifies the hospital that the result of the

FDA-licensed, more specific test or other followup testing recommended

or required by FDA is negative, absent other informative test results,

the hospital may release the blood and blood products from quarantine.

(ii) If the blood bank notifies the hospital that the result of the

FDA-licensed, more specific test or other followup testing recommended

or required by FDA is positive, the hospital must dispose of the blood

and blood products in accordance with 21 CFR 606.40 and notify patients

in accordance with paragraph (c)(4) of this section.

(4) Patient notification. If the hospital has administered

potentially HIV infectious blood or blood products (either directly

through its own blood bank or under an agreement described in paragraph

(c)(2) of this section) or released such blood or blood products to

another entity or appropriate individual, the hospital must take the

following actions:

(i) Promptly make at least three attempts to notify the patient's

attending physician (that is, the physician of record) or the physician

who ordered the blood or blood product that potentially HIV infectious

blood or blood products were transfused to the patient.

(ii) Ask the physician to immediately notify the patient, or other

individual as permitted under paragraph (c)(8) of this section, of the

need for HIV testing and counseling.

(iii) If the physician is unavailable, declines to make the

notification, or later informs the hospital that he or she was unable

to notify the patient, promptly make at least three attempts to notify

the patient, or other individual as permitted under paragraph (c)(8) of

this section, of the need for HIV testing and counseling.

(iv) Document in the patient's medical record the notification or

attempts to give the required notification.

(5) Timeframe for notification. The notification effort begins when

the blood bank notifies the hospital that it received potentially HIV

infectious blood and blood products and continues for 8 weeks unless--

(i) The patient is located and notified; or

(ii) The hospital is unable to locate the patient and documents in

the patient's medical record the extenuating circumstances beyond the

hospital's control that caused the notification timeframe to exceed 8

weeks.

(6) Content of notification. The notification given under

paragraphs (c)(4) (ii) and (iii) of this section must include the

following information:

(i) A basic explanation of the need for HIV testing and counseling.

(ii) Enough oral or written information so that the transfused

patient can make an informed decision about whether to obtain HIV

testing and counseling.

(iii) A list of programs or places where the patient can obtain HIV

testing and counseling, including any requirements or restrictions the

program may impose.

(7) Policies and procedures. The hospital must establish policies

and procedures for notification and documentation that conform to

Federal, State, and local laws, including requirements for

confidentiality and medical records.

(8) Notification to legal representative or relative. If the

patient has been adjudged incompetent by a State court, the physician

or hospital must notify a legal representative designated in accordance

with State law. If the patient is competent, but State law permits a

legal representative or relative to receive the information on the

patient's behalf, the physician or hospital must notify the patient or

his or her legal representative or relative. If the patient is

deceased, the physician or hospital must continue the notification

process and inform the deceased patient's legal representative or

relative.

(Catalog of Federal Domestic Assistance Program No. 93.773,

Medicare--Hospital Insurance; Program No. 93.774, Medicare--

Supplementary Medical Insurance; and Program No. 93.778, Medical

Assistance Program)

[[Page 47434]]

Dated: July 11, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: July 11, 1996.

Donna E. Shalala,

Secretary.

[FR Doc. 96-22708 Filed 9-6-96; 8:45 am]

BILLING CODE 4120-01-P