[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47423-47434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22708]


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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