HIV AIDS Resource Guide/HIV-AIDS Resource Guide.iso/STAT/PROP_FED/CFR-3ABC.ASC

Text File | 1993-01-14 | 21KB | 613 lines

/* These blood handling rules were proposed by the federal

government in Autumn 1993.  If finalized, they will be

enforced in any hospital which received Medicare funds. */



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 482

Medicare Program; Hospital Standard for HIV Infectious Blood

and Blood Products

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

ACTION:   Proposed rule.





SUMMARY:  This proposed rule would address a blood and blood
products safety issue that concerns the prompt notification of
transfusion recipients who are at increased risk of HIV
infection. Thus, this proposed rule would require hospitals to
notify the recipient's attending physician when potentially HIV
infectious blood and blood products have been administered, and
ask the physician to inform the recipient of the need for HIV
testing and counseling. If the physician is unavailable or
declines to notify the recipient, the hospital must notify the
recipient and inform the recipient of the need for HIV testing
and counseling.


DATES:    Written comments will be considered if we receive
them at the appropriate address, as provided below, no later
than 5:00 p.m. on August 30, 1993.



ADDRESSES: Mail written comments (1 original and 3 copies) to
the following address: Health Care Financing Administration,
Department of Health and Human Services, Attention: BPl3-633-P,
P.O. Box 26688, Baltimore, MD 21207.



If you prefer, you may deliver your written comments (1
original and 3 copies) to one of the following addresses: Room
309-G, Hubert H. Humphrey Building, 200 Independence Ave., SW.,
Washington, DC 20201, or room 132, Fast High Rise Building,
6325 Security Boulevard, Baltimore, Maryland 21207.



Due to staffing and resource limitations, we cannot accept
audio, visual, or facsimile (FAX) copies of comments.



If comments concern information collection or recordkeeping
requirements, please address a copy of comments to: Office of
Management and Budget, Office of Information and Regulatory
Affairs, Room 3206, New Executive Office Building, Washington,
DC 20503, Attention: Allison Herron Eydt.



In commenting, please refer to file code BPD633-P. Comments

received timely will be available for public inspection as they

are received, beginning approximately three weeks after

publication of this document, in Room 309-G of the Department's

offices at 200 Independence Ave., SW., Washington, DC, on

Monday through Friday of each week from 8:30 a.m. to 5 p.m.

(phone: [phone]).



FOR FURTHER INFORMATION CONTACT:

Joyce Eng, [phone].





SUPPLEMENTARY INFORMATION:

I. Background





Hospitals must meet certain conditions of participation in
order to participate in the Medicare program. These conditions
are intended to protect patient health and safety and to ensure
that high-quality care is provided to Medicare patients.






Regulations containing the Medicare conditions of participation
for hospitals are located in the Code of Federal Regulations at
42 CFR part 482, with the conditions for hospital laboratory
services at  482.27. The laboratory regulations at  482.27 are
relatively general because 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 programs. Part 493
was added to the CFR on March 14, 1990 (55 FR 9538).






The Human Immunodeficiency Virus (HIV) is a virus whose
presence is associated with Acquired Immune Deficiency Syndrome
(AIDS). Receipt of potentially HIV infectious blood and blood
products does not mean that a person will get AIDS, but it
indicates a likelihood that one may, depending upon the
recipient's immunity and other factors.






In response to scientific data that show HIV is transmissible
through blood and blood products, the Food and Drug
Administration (FDA) has implemented an extensive system of
additional donor screening and testing procedures, performed
before, during, and after donation takes place, to help prevent
the transfusion of blood and blood products that are
potentially contaminated with HIV. The FDA continues to monitor
blood donor issues and updates its recommendations as more
information becomes available.






The Social Security Administration operates a Blood Donor
Locator Service (BDLS) 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 205(c)(2)(D) of

the Act permits States to require a blood donor to furnish his

or her Social Security number (SSN) to a State agency or to an

authorized blood donation facility. With the SSN, an authorized

blood donation facility may request the State to contact the

BDLS to obtain the donor's last known personal mailing address.

The State agency may also make a request on its own behalf for

this information to the BDLS.



II. Provisions of the Regulations



This proposed rule would amend the conditions of participation
for hospitals to require hospitals to develop agreements which
would require outside blood banks to notify the hospitals when
the blood banks have made potentially HIV infectious blood and
blood products available to the hospitals. We also would
require that the hospitals ensure that the recipients of the
blood and blood products be notified and informed of the need
for HIV testing and counseling. Testing persons for HIV could
allow individuals who test positive to seek medical treatment
and to change behavior so as not to infect others.






This proposed rule would set forth a new standard for hospitals
at  482.27, which sets forth standards for hospital laboratory
services. Section 482.27(c)(1) would require that, when
services are furnished to a hospital by an outside blood bank,
there be an agreement governing the procurement, transfer and
availability of blood and blood products specifying that the
blood bank notify the hospital if potentially HIV infectious
blood and blood products have been made available to the
hospital. We are especially interested in receiving comments on
whether this proposed requirement would be more appropriately
implemented in the manner proposed, as part of a Medicare
hospital standard, or as part of the FDA requirements
applicable to blood banks.






Potentially  infectious blood and blood products would be
defined as blood and blood products from a donor whose licensed
or approved screening test shows the presence of HIV and whose
licensed or approved screening supplemental, more specific
tests are positive or unavailable. An individual would be
considered to be infected by HIV if the individual's results
from the FDA's licensed or approved tests at 21 CFR 610.45 show
the presence of HIV and if these screening results are
confirmed by a licensed or approved supplemental, more specific
test.






A new paragraph (c) (2) would require that, if a hospital has
administered potentially HIV infectious blood and blood
products, the hospital must first make several attempts to
notify the recipient's attending physician (physician of
record) and ask the physician to inform the recipient of the
need for HIV testing and counseling. Then, if the physician is
unavailable or declines to notify the recipient, the hospital
must make several attempts to notify the recipient and inform
the recipient of the need for HIV testing and counseling. The
notification must be confidential. The hospital is responsible
for notification, including basic
explanations to the recipient and referral for counseling.



We believe that the hospital's notification effort should
consist of, at the minimum, several attempts by phone or in
writing to reach the attending physician and then, the
recipient. The hospital's notification effort should begin
immediately after receiving word from the blood bank and be
completed eight weeks later. We would require that the hospital
document the attempts to notify the attending physician, the
attempts to notify the recipient, and indicate whether the
recipient was located. We specifically invite public comment on
the sufficiency of this level of effort and on whether the
notification should be done by certified mail marked
"confidential".



In the proposed 482.27(c)(2), we believe that the chain of
notification about the potentially infectious blood and blood
products should be from the hospital to the recipient's
attending physician      (physician of record), and that only
in rare situations would the recipient receive this
notification from the hospital. We invite comment as to whether
a regulation describing the mechanics of this notification is
necessary and whether additional explanation is necessary to
identify when the hospital should directly notify the
recipient. We believe this proposed rule is self-explanatory;
but that a stated time frame may be necessary to determine when
the recipient should be notified by the hospital if the
attending physician cannot be reached by telephone.



If a hospital furnishes HIV testing or counseling, we do not
anticipate that the hospital will furnish these services
without costs. It may choose to furnish the services and bill
the recipient, or it may refer the recipient to a public health
agency or a laboratory. Medicare and Medicaid would pay for
services they cover (coverage would vary, depending on which
program was used and which services were furnished). Private
insurance may pay for non-Medicare or non-Medicaid patients.



We have not yet determined whether these new requirements
should be independently verified by a survey or whether
hospitals accredited by the Joint Commission on Accreditation
of Healthcare Organizations (JCAHO) and the American
Osteopathic Association (AOA) can be assumed to meet these
requirements. Because accreditation standards change regularly,
this proposed new requirement may well be incorporated into the
accreditation programs of the JGAHO and the AOA. When a final
regulation is published, we will announce whether accreditation
by one of these organizations creates presumptive compliance or
whether a compliance survey will be performed.



This proposed rule addresses hospital requirements only,
because we believe the overwhelming majority of blood and blood
products are furnished in hospitals. However, we welcome public
comment regarding the need to develop similar requirements for
other types of facilities.



III. Regulatory Impact Analysis



Executive Order 12291 (E.O. 12291) requires us to prepare and

publish a regulatory impact analysis for any proposed rule that

meets one of the E.O. 12291 criteria for a "major rule"; that

is, that would be likely to result in-



An annual effect on the economy of $100 million or more;



 A major increase in costs or prices for consumers, individual
industries, Federal, State, or local government agencies, or
geographic regions; or



Significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of
United States-based enterprises to compete with foreign-based
enterprises in domestic or export markets.



In addition, we generally prepare a regulatory flexibility
analysis that is consistent with the Regulatory Flexibility Act
(RFA) (5 U.S.& 601 through 612) unless the Secretary certifies
that a proposed rule would not have a significant economic
impact on a substantial number of small entities. For purposes
of the RFA, we consider all hospitals, blood banks and
physicians to be small entities.



Also, section 1102(b) of the Act requires the Secretary to
prepare a regulatory impact analysis if a proposed rule may
have a significant impact on the operations of a substantial
number of small rural hospitals. Such an analysis must conform
to the provisions of section 603 of the RFA. For purposes of
section 1102(b) of the Act, we define a small rural hospital as
a hospital with fewer than 50 beds located outside of a
Metropolitan Statistical Area.



This proposed rule would add a new paragraph (c) to  482.27
regarding the notification of a patient when potentially HIV
infectious blood and blood products have been administered.
These proposed regulations do not affect blood testing required
by 493.1269 ("Condition: Immunohematology").



From 1988 through 1991, the risk of HIV transmission via blood
and blood products transfusion has been estimated to be between
1 in 38,000 and 1 in 153,000. 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,
when the test for
anti-HIV remains negative but HIV is present in the person's
blood. Section 482.24 ("Condition of participation: Medical
record services") currently requires hospitals to maintain
records for a period of 5 years. We expect hospitals would
identify recipients of blood and blood products and furnish
appropriate notice to the extent to which they have maintained
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 transfused blood and blood products, and thus, we do
not expect these proposed regulations would result in a
substantial economic or resource burden on hospitals, blood
banks or physicians. We do not have estimates of the additional
cost due to the HIV counseling and subsequent testing that
would be required, but since the services would be covered for
those persons eligible to receive Medicare and Medicaid
benefits, if they meet other eligibility and coverage
requirements, we believe the effect on beneficiaries, even in
high risk areas, would be minimal. To the extent possible,
private insurance may also pay, or, if the State has a program,
the Ryan White Comprehensive AIDS Resource Emergency Act of
1990 (Pub. L. 101- 381) may cover some of these services. In
addition. since many hospitals, blood banks, and physicians are
currently voluntarily complying with the requirements of these
proposed regulations, new effects due to these proposed
regulations are not expected to be substantial. We expect the
continued cost of implementing this regulation after the
initial implementation to be small because the risk of a person
being transfused with potentially HIV infectious blood and
blood products is declining. Even though this proposed rule
would affect few people per year after initial implementation,
public awareness of the HIV issue dictates that we address it
by  taking steps to ensure that potentially infected people are
notified so they may seek appropriate medical care or consider
behavior changes so as not to infect others.



As part of this proposed rule, blood banks with records that
permit them to do so may notify hospitals of potentially HIV
infectious blood and blood products provided in past years.
Recipients of potentialy HIV blood and blood products would
need to be notified and informed of the need for HIV testing
and counseling. Since it is extremely important to notify these
individuals that they have the potential to transmit the HIV
virus to others, it is necessary that they be identified and
notified, and that their status be assessed. This is critical
to the epidemiology of AIDS.



For the reasons cited above, we do not believe these proposed
regulations would meet any of the criteria for a major rule,
therefore we are not including an initial regulatory impact
analysis.



In addition, since we have determined, and the Secretary
certifies, that this proposed rule would not be likely to have
a significant economic impact on a substantial number of small
entities or on the operations of a substantial number of small
rural hospitals, we are not preparing analyses for either the
RFA or small rural hospitals.


IV.  Information Collection



Requirements



Section 482.27(c)(2) of this proposed rule contains information

collection requirements that are subject to review by the

Office of Management and Budget (OMB) under the authority of

the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).

This section requires that, if potentially HIV infectious blood

and blood products are administered, regardless of the source

of the blood, a hospital must first make several attempts to

notify the recipient's attending physician and ask the

physician to inform the recipient of the need for HIV testing

and counseling. Then, if the physician is unavailable, or

declines to notify the recipient, the hospital must make

several attempts to notify the recipient and inform the

recipient of the need for HlV testing and counseling. The

hospital must also document the notification or attempts to

notify the attending physician and the recipient. Public

reporting burden for the collection of information is estimated

to be 1 hour per response. A notice will be published in the

Federal Register if approval is obtained. Other organizations

and individuals desiring to submit comments regarding the

burden estimate or any aspect of this collection of

information, including suggestions for reducing this burden,

should direct them to the OMB official whose name appears in

the "ADDRESSES" section of this preamble.



V.   Response to Comments



Because of the large number of items of correspondence we
normally receive on a proposed rule, we are not able to
acknowledge or respond to them individually. However, we will
consider all comments that we receive by the date and time
specified in the "DATES" section of this preamble, and if we
proceed with a final rule, we will respond to the comments in
the preamble of that rule.






List of subjects in 42 CFR Part 482

Hospitals, Medicaid, Medicare, Reporting and recordkeeping
requirements.

For the reasons set forth in the preamble, Chapter IV, 42 CFR
482.27 would be 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, 1136, 1138, 1814 (a)(6), 1861(e), (f),
(k), (r), (v)(1)(G), (z), and (ee), 1864, 1871, 1883, 1886,
1902 (a)(30), and 1905(a) of the Social Security Act (42 U.S.C.
1302,
1302b-6, 1338, 1395f(a)(6), 1395x(e), (f), (k), (r),

(v)(1)(G), (z) and (ee), 1395aa, 1395hh, 1395tt, 1395ww,

1396a(a)(30), and 1396(a).

2.   In 482.27, a new paragraph (c) is added as follows:

482.27 Condition of participation; Laboratory services.

* * * * *

(c)  Standard: Infectious blood and blood products.

(1)  When services are furnished by an outside blood bank, the
hospital must have an agreement governing the procurement,
transfer, and availability of blood and blood products.  The
agreement must require that the blood bank notify the hospital
if potentially HIV infectious blood and blood products have
been made available to the hospital.  "Potentially HIV
infectious blood and blood products" is defined as blood and
blood products from a donor whose licensed or approved
screening test shows the presence of HIV and whose licensed or
approved screening supplemental, more specific tests are
positive or unavailable.


An individual would be considered to be infected by HIV if the
individual's results from the FDA's licensesd or approved tests
at 21 CFR 610.45 show the presence of HIV, and if these
screening results are confirmed by a licensed or approved
supplemental, more specific test.


(2)  If a hospital has administered potentially HIV infectious
blood and blood products, the hospital must make several
attempts to notify the recipient's attending physician
(physician of record) and ask him or her to inform the
recipient of the need for HIV testing and counseling.  If the
physician is unavailable or declines to notify the recipient,
the hospital must make several attempts to notify the recipient
and inform the recipient of the need for HIV testing and
counseling.  The hospital is responsible for notification,
including basic explanations to the recipient and referral for
counseling, and nust document the notification or attempts to
notify the attending physician and the recipient.


(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare -- Supplementary Medical Insurance.)


Dated:  March 2, 1993


William Toby, Jr., Acting Deputy Administrator, Health Care
Finincing Administation.


Approved:  May 19, 1993.


Doonna E. Shalala, Secretary.


[FR Doc. 93-15357 Filed 6-29-93; 8:45 am]