[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
