[Federal Register: November 16, 2000 (Volume 65, Number 222)]
[Proposed Rules]
[Page 69416-69424]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no00-15]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 482
[HCFA-3014-P]
RIN 0938-AJ29
Medicare and Medicaid Programs; Hospital Conditions of
Participation: Laboratory Services
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would require hospitals that transfuse
blood and blood products to prepare and follow written procedures for
appropriate action when it is determined that blood and blood products
the hospitals received and transfused are at increased risk for
transmitting hepatitis C virus (HCV); quarantine prior collections from
a donor who is at increased risk for transmitting HCV infection; notify
transfusion recipients, as appropriate, of the need for HCV testing and
counseling; and extend the records retention period to 10 years.
These changes are based on recommendations by the Secretary's
Advisory Committee on Blood Safety and Availability. The intent is to
aid in the prevention of HCV infection and to create opportunities for
disease prevention many years after recipient exposure to a donor.
DATES: We will consider written comments if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on or
before January 16, 2001.
ADDRESSES: Mail written comments (one original and three copies) to the
following address: Health Care Financing Administration, U.S.
Department of Health and Human Services, P.O. Box 8010, Attention:
HCFA-3014-P, 7500 Security Boulevard, Baltimore, Maryland 21244-8010.
If you prefer, you may deliver your written comments (one original
and three copies) to one of the following addresses:
Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or,
Room C5-09-26, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Because of staffing and resource limitations, we cannot accept
audio, visual, or facsimile (FAX) copies of comments. In commenting,
please refer to file code HCFA-3014-P. Comments received timely will be
available for public inspection as they are received, generally
beginning approximately 3 weeks after publication of a document, in
room 443-G of the Department's offices at 200 Independence Avenue, SW.,
Washington, DC, on Monday through Friday of each week from 8:30 a.m. to
5 p.m. (phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Mary Collins, (410) 786-3189.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 1861(e) of the Social Security Act (the
Act), 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 Medicare
conditions of participation.
Regulations containing the Medicare conditions of participation for
hospitals are located in the Code of Federal Regulations at 42 CFR part
482. The condition of participation for hospital laboratory services at
Sec. 482.27 (c) currently specifies the steps hospitals must take when
they become aware they have administered potentially human
immunodeficiency virus (HIV) infectious blood or blood products to a
patient. The more detailed requirements for laboratories appear in 42
CFR part 493, which sets forth requirements for all laboratories
participating in the Medicare, Medicaid, and Clinical Laboratory
Improvement Amendments (CLIA) programs.
The Health Care Financing Administration (HCFA) and the Food and
Drug Administration (FDA) are responsible for 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, 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). Laboratories in hospitals are also subject to
the hospital conditions of participation for adequacy of laboratory
services (42 CFR 482.27). HCFA coordinates inspections of hospital-
based blood banks with the FDA to minimize duplication of effort and
reduce the burden on affected facilities.
Hepatitis C virus (HCV) was first discovered and established as a
causative agent of transfusion-associated hepatitis in the late 1980s.
In October 1989, FDA's Blood Products Advisory Committee (BPAC) first
discussed steps to identify and quarantine potentially HCV infectious
blood and blood products remaining in storage and notify recipients of
the blood. (These steps are known as ``lookback.'') BPAC advised that
there was insufficient information available concerning HCV infection
to propose either product quarantine or notification of recipients
transfused with products prepared from prior collections from donors
later determined to be at increased risk for transmitting HCV.
In 1996, the Tenth Report of the U.S. House of Representatives
Committee on Government Reform and Oversight (H. Rpt. No. 104-746)
focused attention on the significant public health problem that HCV
infections pose for the nation. HCV infection is the most common blood-
borne infection in the United States. The Centers for Disease Control
and Prevention (CDC) estimate that during the 1980s, as many as 180,000
new HCV infections occurred each year. Since 1989, the annual number of
new infections has declined by 80 percent. Currently approximately 4
million individuals in the United States are believed to be chronically
infected with HCV.
In 1996, however, data from the Third National Health and
Nutritional Examination Survey conducted from 1988 to 1994 indicated
that chronically infected persons may not be aware of their infection.
Despite progression of the disease, HCV infection is usually
asymptomatic for about 20 years, but in many cases causes serious liver
injury that is thought to be the leading cause of late stage liver
failure and cirrhosis in the United States. HCV is also thought to play
a significant role in the development of liver cancer. Between 8,000
and 12,000 deaths annually result from HCV-related chronic liver
disease.
HCV can be transmitted in a number of ways, including sharing of
drug use equipment among injection drug users, blood transfusion and
solid organ
[[Page 69417]]
transplants from infectious donors, hemodialysis, occupational exposure
to blood, perinatal exposure of infants to infected mothers, and
unprotected sex.
In response to scientific data that show that HCV 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 HCV.
Blood establishments are currently testing each donation of blood
and blood components for the antibody to HCV. FDA restricts the use,
for transfusion or further manufacture, of donations testing repeatedly
reactive for the antibody to HCV. Repeatedly reactive means that the
initial HCV antibody screening test is reactive (in which case it is
retested in duplicate), and that 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 HCV infections through blood
transfusion is very low. Despite the best practices of blood
establishments, however, a person may donate blood early in the
infection process when the antibody to HCV is not detectable by the
screening test but is nevertheless 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 HCV may at that time be
repeatedly reactive. Under these circumstances, previously collected
blood and blood products would be at increased risk for transmitting
HCV, and a recipient of a blood product collected during the window
period would not know whether the donor was infected with HCV at the
time of the previous donations. Approximately 7 percent of the 3.9
million Americans believed to be chronically infected with HCV were
infected as a result of transfusion of blood components before the
availability of donor screening tests or due to past use of non-viral-
inactivated plasma derivative products. \1\
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\1\ M.J. Alter, ``Epidemiology of Hepatitis C,'' Hepatology 26.3
(1997): 62s-65s.
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As a result of advances in identifying the presence of HCV, the
window period continues to shrink. The FDA proposed rule titled
``Current Good Manufacturing Practice for Blood and Blood Components:
Notification of Consignees and Transfusion Recipients Receiving Blood
and Blood Components at Increased Risk of Transmitting HCV Infection
(`Lookback'),'' published elsewhere in this issue of the Federal
Register, provides more information on the length of the window period
and discusses various diagnostic modalities for HCV infection.
The incidence of transfusion-transmitted HCV infection has
decreased markedly since the implementation of donor screening for HCV
and viral inactivation of clotting factors and intravenous immune
globulins. Blood establishments implemented donor screening tests after
a single antigen, enzyme linked immunosorbent assay (EIA) for antibody
to HCV (HCV EIA 1.0 screening test) was licensed in May 1990. FDA
issued a memorandum to all registered blood establishments in November
1990, ``Testing for Antibody to Hepatitis C Virus Encoded Antigen
(Anti-HCV),'' recommending use of approved donor screening tests for
antibody to HCV. A lookback program was not recommended because: (1)
Screening tests available at the time could not distinguish between on-
going infection and recovery, thus rendering unclear the meaning of a
reactive test for any one individual; (2) donor screening for antibody
to HCV did not include confirmatory testing, and most notification
would have been based on false positive donor test results; (3) there
was limited knowledge of routes of transmission for HCV other than
parenteral; and (4) no potential long-term benefits of therapy were
known.
A significantly more sensitive multiantigen screening test (HCV EIA
2.0 screening test) was licensed in March 1992. In June 1993, FDA
licensed an HCV 2.0 strip immunoblot assay (HCV RIBA 2.0), also known
as recombinant immunoblot assay (RIBA), a supplemental test for
antibody to HCV. Supplemental tests for antibody to HCV are used to
distinguish false positive test results from true repeatedly reactive
screening test results. Following the December 1993 BPAC meeting, BPAC
recommended product quarantine of prior collections from a donor who
later tests repeatedly reactive for the antibody to HCV and tests
positive or indeterminate on a supplemental test; however, BPAC only
marginally endorsed consignee notification for the purpose of
transfusion recipient notification because the public health benefit of
the notification was not clear.
The Public Health Service Advisory Committee on Blood Safety and
Availability (PHS Advisory Committee) discussed improvements in the
treatment and management of HCV infection and improvements in testing
for the antibody to HCV at public meetings held on April 24, 1997 and
on August 11 and 12, 1997. The PHS Advisory Committee also discussed
the public health benefits of notifying transfusion recipients
receiving prior collections from a donor who subsequently tests
repeatedly reactive for evidence of HCV infection. Following the
Department of Health and Human Services' acceptance of recommendations
from the PHS Advisory Committee, the FDA developed guidance, published
in March 1998, regarding procedures for testing blood for HCV,
quarantining blood and blood products, and notifying patients who may
have received HCV-infected blood and blood products.
At public meetings on November 24, 1998 and January 28, 1999, the
PHS Advisory Committee reconsidered the issue of recipient notification
related to repeatedly reactive results on the single antigen screening
test. The PHS Advisory Committee recommended that targeted lookback
should be initiated based on a repeatedly reactive HCV EIA 1.0
screening test result on a repeat donor unless a supplemental test was
performed and the result did not indicate increased risk of HCV
infection, or, in the absence of a supplemental test result, unless the
signal to cut off value of the repeatedly reactive HCV EIA 1.0
screening test was less than 2.5 or follow-up testing of the donor was
negative.
FDA published a notice in the Federal Register on June 22, 1999 (64
FR 33309) announcing the availability of a draft guidance titled
``Guidance for Industry: Current Good Manufacturing Practice for Blood
and Blood Components: (1) Quarantine and Disposition of Prior
Collections from Donors with Repeatedly Reactive Screening Tests for
Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification
of Consignees and Transfusion Recipients of Donor Test Results for
Antibody to HCV (Anti-HCV).'' Consistent with the recommendations of
the PHS Advisory Committee, this revised draft guidance addressed
lookback actions related to donor screening by HCV EIA 1.0 and also
recommended that the search of historical testing records of prior
donations from donors with repeatedly reactive EIA 1.0, EIA 2.0, or EIA
3.0 screening tests for HCV should extend back indefinitely to the
extent that electronic or other retrievable records exist.
In the proposed rule titled ``Medicare and Medicaid Programs;
Hospital Conditions of Participation; Provider Agreements and Supplier
Approval'' (HCFA-3745-P), published on
[[Page 69418]]
December 19, 1997 in the Federal Register (62 FR 66726), we proposed to
revise the hospital conditions of participation to focus on patient
care outcomes, reflect a cross-functional view of the hospitals'
organization and patient treatment, encourage flexibility in meeting
quality standards, and eliminate outdated and redundant evaluation
criteria. The lookback requirement for HIV infectious blood and blood
products was the only lookback under this proposed condition. The HIV
requirement was restated without change in the existing Sec. 482.27(c).
This requirement would merely be redesignated under this proposed rule.
We are still in the process of analyzing comments we received on the
December 19, 1997 proposed rule as we develop the final rule.
Should the restructuring of part 482 in the December 19, 1997
proposed rule become final before we publish this proposed rule (HCFA-
3014-P) as a final rule, the provisions dealing with potentially HCV
infectious blood and blood products would be set forth in the final
rule (HCFA-3014-F) as a revision to Sec. 482.145.
II. Provisions of This Proposed Rule
In order to have consistent industry standards for potentially
infectious blood and blood products, we propose to adopt as our
requirements for hospitals the procedures for HIV and HCV proposed by
the FDA published elsewhere in this issue of the Federal Register.
Since our proposed rule is in concert with the FDA's proposed rule, we
will consider comments we receive in conjunction with the FDA. We
specifically request comments on the reasonableness of our adopting the
FDA requirements.
The FDA proposed rule for HCV lookback would require the search of
historical testing records of prior donations from donors with
repeatedly reactive EIA 1.0, EIA 2.0, or EIA 3.0 screening tests for
HCV to extend back indefinitely for computerized electronic records and
to January 1, 1998 for other retrievable records. Under the FDA rule,
the blood establishment would notify the hospital if it supplied the
hospital with potentially HIV or HCV infectious blood.
Our proposed rule would amend the hospital conditions of
participation to require a hospital to develop agreements with outside
blood banks under which the blood bank would notify the hospital when
it has supplied the hospital with potentially HCV infectious blood and
blood products. This proposed rule would establish a lookback, similar
to that now in effect for HIV, requiring hospitals, when notified by
blood banks, to quarantine prior collections from a donor who later
tests repeatedly reactive for evidence of HCV infection, and to notify
transfusion recipients based on further testing of such a donor, as
appropriate.
In existing Sec. 482.27, we propose to remove the designation for
paragraph (a) and redesignate paragraphs (b) and (c) as (a) and (b),
respectively. In addition, we would add a definition of potentially HCV
infectious blood and blood products as prior collections from a donor
who tested repeatedly reactive for evidence of HCV infection on a
single antigen screening test with a signal to cut off value equal to
or greater than 2.5 for at least two of the three EIA tests, or the
signal to cut off value cannot be calculated, and with no record of
further testing; who tests or tested repeatedly reactive for evidence
of HCV infection and positive on a multiantigen supplemental test
licensed at an earlier or later date by FDA; who tested repeatedly
reactive for evidence of HCV infection and indeterminate on a
supplemental test for HCV, unless an indeterminate RIBA 3.0
supplemental test result was obtained or a negative EIA 3.0 or negative
RIBA 3.0 test result was subsequently obtained; who tested repeatedly
reactive for evidence of HCV infection on a multiantigen screening test
with no record of further testing; or who tested repeatedly reactive
for evidence of HCV infection on a single antigen screening test and
repeatedly reactive on a subsequent multiantigen screening test, unless
a negative supplemental test result or an indeterminate RIBA 3.0
supplemental test result was obtained. (See proposed
Sec. 482.27(b)(2).)
Our regulations currently require that a hospital that regularly
uses the services of an outside blood bank have an agreement with the
blood bank that requires the blood bank to notify the hospital if the
blood bank has supplied the hospital with potentially HIV infectious
blood. This proposed rule would amend that provision to also require
notification in the case of potentially HCV infectious blood. (See
proposed Sec. 482.27(b)(3).) In addition, we would revise our
regulations to include HCV-relevant testing required by FDA. (See
proposed Sec. 482.27(b)(3)(ii).)
As a new provision, we would require hospitals to include in
agreements with blood banks that the blood bank notify the hospital
under FDA's proposed 21 CFR 610.48(h)(3)(i) and (h)(3)(ii), and
(i)(3)(i) and (i)(3)(ii). The FDA's proposed rule would require
hospitals to perform a lookback of blood or blood products collected
from a donor extending back indefinitely for computerized electronic
records and to January 1, 1998 for other retrievable records, or to the
date 12 months before the donor's most recent negative multiantigen
screening test for the antibody to HCV, whichever is the later date.
(See proposed Sec. 482.27(b)(3)(ii) and (b)(3)(iii).)
We would also revise our regulations to apply the provisions
regarding the quarantine of potentially HIV infectious blood and blood
products currently set forth at Sec. 482.27(c)(3) to potentially HCV
infectious blood and blood products. In addition, we would require
hospitals to destroy or label prior collections of blood or blood
products held in quarantine as set forth in FDA's proposed 21 CFR
610.48(k). (See proposed Sec. 482.27(b)(4).)
Hospitals are currently required to maintain clinical records on
all patients for 5 years. We would add a new provision requiring
hospitals to maintain adequate records of the source and disposition of
all units of blood and blood products for at least 10 years from the
date of disposition. Hospitals would be required to increase the record
retention period yearly until 10 years of records from the date of
disposition have accrued. (For example, the first year after the
effective date of this regulation, hospitals would have 6 years of
records, the second year after the effective date, 7 years, etc., until
10 years have been reached.) Hospitals would then be able and expected
to maintain 10 years of patient records. (See proposed
Sec. 482.27(b)(5).) This is necessary to increase opportunities for
disease prevention or treatment years after a recipient has been
exposed to a donor later determined to be at risk of transmitting a
disease through transfusion.
The FDA has proposed changes in its requirement for patient
notification to allow transfusion services to make three attempts to
either notify patients directly or notify the attending physician or
the physician who ordered the blood. We are proposing that hospitals
follow the same notification procedures with regard to potentially HIV
and HCV infectious blood and blood products. For consistency, we are
also proposing that the HIV lookback requirements be changed to conform
to the requirements for HCV lookback. (See proposed Sec. 482.27(b)(6).)
We propose to add a new paragraph (c) requiring hospitals to comply
with FDA regulations pertaining to the appropriate testing and
quarantining of infectious blood and blood products and to the
notification and counseling of
[[Page 69419]]
recipients that may have received infectious blood and blood products.
Note that our Medicaid regulations at Sec. 441.17 (``Laboratory
services'') provide that the State plan must pay for laboratory
services furnished by a hospital-based laboratory meeting the
requirements for Medicare participation set forth in Sec. 482.27.
Therefore, the provisions of this proposed rule would also affect the
Medicaid program. That is, in order for the laboratory services
furnished by a hospital-based laboratory under Medicaid to be covered
under the State plan, the hospital would have to meet the new
requirements set forth in this proposed rule.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, agencies are required to
provide a 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, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)) requires that we solicit comment on
the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Therefore, we are soliciting public comment on each of these issues
for the provisions summarized below that contain information collection
requirements:
Section 482.27 Condition of participation: Laboratory services
In summary, Sec. 482.27(b)(3) requires a hospital that regularly
uses the services of an outside blood bank to establish and maintain a
written agreement with the blood bank that governs the procurement,
transfer, and availability of blood and blood products. This section
also requires the blood bank to notify the hospital within 3 calendar
days after the date on which the donor tested repeatedly reactive for
evidence of HCV infection or after the date on which the blood
establishment was made aware of other test results indicating evidence
of HCV infection, as outlined in (i) through (iii).
In summary, Sec. 482.27(b)(5) requires a hospital to maintain, in a
manner that permits prompt retrieval, adequate records of the source
and disposition of all units of blood and blood products for at least
10 years from the date of disposition. In addition, this section
requires a hospital to maintain a fully funded and documented plan that
demonstrates how the hospital will transfer these records to another
hospital or other entity if the former hospital ceases operation for
any reason.
In summary, Sec. 482.27(b)(6) requires a hospital that has
administered potentially HIV or HCV infectious blood or blood products
(either directly through its own blood bank or under an agreement), or
released the blood or blood products to another entity or individual,
to make at least three attempts to notify the patient, or to notify the
attending physician or the physician who ordered the blood or blood
product and ask the physician to notify the patient, that potentially
HIV or HCV infectious blood or blood products were transfused to the
patient. Time frame and notification requirements are outlined in
Secs. 482.27(b)(6), (b)(7), and (b)(8).
In summary, Sec. 482.27(b)(9) requires a hospital to maintain
policies and procedures for notification and documentation that conform
to Federal, State, and local laws, including requirements for
confidentiality and medical records.
In summary, Sec. 482.27(b)(10) requires a physician or hospital, if
the patient has been adjudged incompetent by a State court, to 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. If the patient is
a minor, the legal guardian must be notified.
While all of the information collection requirements referenced
above are subject to the Paperwork Reduction Act, the burden associated
with these requirements is captured and discussed in the FDA's proposed
regulation titled ``Current Good Manufacturing Practice for Blood and
Blood Components: Notification of Consignees and Transfusion Recipients
Receiving Blood and Blood Components at Increased Risk of Transmitting
HCV Infection (`Lookback'),'' Docket No. 98N-0609. Therefore, we are
assigning 1 token hour of burden to these requirements.
The FDA's rule assigns a one-time burden of 16 hours for hospitals
to develop procedures to conduct lookback activities. HCFA also
requires hospitals that currently receive blood from an outside blood
bank to have an agreement with the blood bank that governs the
procurement, transfer, and availability of blood and blood products for
HIV. Our proposed rule would require those hospitals to modify their
current agreements to include HCV. Although the FDA does not require
hospitals to have this agreement, we believe that the time necessary to
perform this task would be minimal and is already captured in the 16
hours allotted in the FDA rule.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirement. These requirements
are not effective until they have been approved by OMB. A notice will
be published in the Federal Register when approval is obtained.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Security and Standards Group, Division of HCFA Enterprise Standards,
Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. Attn:
John Burke, HCFA-3014-P, Fax number: (410) 786-0262,
and,
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503. Attn.: Allison Herron Eydt, HCFA Desk Officer, Fax numbers:
(202) 395-6974 or (202) 395-5167.
IV. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
[[Page 69420]]
V. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of the proposed rule as required by
Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L.
96-354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more annually). Because the
projected cost of this proposed rule falls below the threshold for a
major rule, we have determined that this proposed rule is not a major
rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $5
million or less annually. Individuals and States are not included in
the definition of a small entity.
In addition, section 1102(b) of the Act requires us to prepare an
RIA 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 603 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area and has fewer
than 50 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) also requires that agencies assess anticipated costs and
benefits before issuing any rule that may result in an expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million in any one year. We believe that this
proposed rule is not an economically significant rule as described in
the Executive Order, nor a significant action as defined in the
Unfunded Mandates Reform Act. Aggregate impacts of the rule, and
aggregate expenditures caused by the rule, would not reach $100 million
for either the public or the private sector. As discussed in the
following paragraphs, because of the lack of information to
characterize the number and volumes of affected blood and blood
products in hospitals that might qualify as small business entities,
the impact on small business establishments is uncertain.
It is clear that a number of hospitals that provide blood
transfusions will be affected by the implementation of this proposed
rule and that a substantial number of those entities will be required
to make changes in their operations. For these reasons, we have
prepared the following voluntary analysis. This analysis, in
combination with the rest of the preamble, is consistent with the
analysis set forth by the RFA.
B. Anticipated Effects
1. Effects on Hospitals
This proposed rule would require hospitals that transfuse blood and
blood products to (1) prepare and follow written procedures for
appropriate action when it is determined that blood and blood products
the hospitals received and transfused are at increased risk for
transmitting HCV; (2) quarantine prior collections from a donor who is
at increased risk for transmitting HCV infection; (3) notify
transfusion recipients, as appropriate, of the need for HCV testing and
counseling; and (4) extend the records retention period to 10 years.
The proposed rule would affect hospitals that transfuse blood and
blood components. We estimate that there are approximately 6,200
Medicare- and Medicaid-participating hospitals. The CDC estimates that
303,676 recipients may need to be notified due to the historical
review.
As indicated previously, the proposed rule would require hospitals
to notify transfusion recipients who received prior collections from a
donor at increased risk for transmitting HCV. The hospital may notify
the attending physician or notify the recipient directly. If the
transfusion recipient is a minor or adjudged incompetent by a State
court, the hospital or physician would be required to notify the
recipient's legal representative. The proposed rule is expected to
generate one-time costs and some additional annual costs for hospitals.
One-time costs include the development of procedures and policies for
recipient notification and the agreement a hospital should have with a
blood bank if it uses the services of an outside bank. We assume that
these tasks will involve a review of current procedures and policies
(for example, for HIV lookback) and the adaptation or modification of
current procedures and policies to address the provisions of this rule,
and we estimate, in consultation with the FDA, that the tasks will
require an average of 16 hours per facility. The Bureau of Labor
Statistics estimates that the total hourly compensation in 1997 for a
staff medical technologist performing the review would be $25.67. Thus,
we estimate the total one-time cost for all 6,200 hospitals to develop
HCV lookback procedures to be $2,546,464 (16 x $25.67 x 6,200). (See
Table in this section.)
For notifications resulting from donors tested on or after the
effective date of the final rule under FDA's proposed
Sec. 610.48(a)(b), the hospital's required notification effort must
include a minimum of three attempts to notify the transfusion
recipient, and the hospital must complete the process within a maximum
of 12 weeks from the time it receives from the blood establishment the
results of the donor's supplemental test for HCV. The following
estimated cost for compliance with provisions concerning the
prospective review and recipient notification is based on: (1) FDA's
estimation of the number of recipient notification multiplied by the
unit cost of each notification. First, the number of annual affected
blood donations was calculated as the product of 12 million donations,
an 80 percent donor rate, and a 12 percent HCV positive donor rate. (2)
The resulting 11,520 figure was then adjusted upward to 12,816 to
reflect the difference found between the number of donors triggering
lookback and the component notifications reported as interim results
from a recent survey conducted by the Centers for Disease Control and
prevention (CDC). (3) The cost per attempted notification is estimated
at $165, which reflects the average cost quoted by a third party
contractor for matching, notifying, testing, counseling, and
documenting lookback efforts for over 100 hospitals.\2\ Although the
proposed rule does not specifically require hospitals to perform
testing and counseling services many do. These assumptions yield an
annual cost of $2,114,640 (12,816 x $165) for hospitals to conduct
prospective lookback activities. (See Table in this section.)
---------------------------------------------------------------------------
\2\ Richard Quattrocchi, Home Access Health Corporation.
---------------------------------------------------------------------------
For notifications resulting from donors tested before the effective
date of the final rule under FDA's proposed Sec. 610.48(c)(d), the
hospital must complete the notification effort within 1 year from the
time it receives notification from the blood establishment. The
recipient notification provided by the hospital
[[Page 69421]]
must include a basic explanation to the recipient, referral for
counseling and further testing, and documentation of the notification
or attempts to notify the attending physician or recipient.
Notification resulting from the review of historical testing records
and the identification of prior collections are to be completed by the
hospital within one year of receipt of notification from the blood
establishment. The recipient notification provided by the hospital
would include a basic explanation to the recipient, referral for
counseling and further testing and documentation of the notification or
attempts to notify the physician of record or recipient. The estimated
one-time cost of recipient notification associated with the review of
historical testing records is $50,106,540. This is based on the CDC
estimate of blood components of about 303,676 recipients identified for
notification produced from donations (188,448 from 1990 to mid-1992 and
115,228 from 1990 to mid-1992), and the average cost of $165 of staff
time per component for recipient notification. Thus, the total one-time
cost to hospitals for conducting the historical ``lookback'' efforts is
estimated to be $52,653,004 ($2,546,464 to develop procedures and
$50,106,540 for recipient notification). (See Table in this section.)
Summary of Estimated Cost of Proposed Rule
----------------------------------------------------------------------------------------------------------------
Total one-time
Type of cost cost Total annual cost
----------------------------------------------------------------------------------------------------------------
Development of HCV Lookback Procedures.................................... \1\ $2,546,464.00 .................
Prospective Review........................................................ ................. \3\ $2,114,640.00
Historical Review......................................................... \2\ 50,106,540.00 .................
-------------------------------------
Total................................................................. 52,653,004.00 2,114,640.00
----------------------------------------------------------------------------------------------------------------
\1\ Based on 6,200 hospitals.
\2\ Based on the CDC estimate of the total number of blood products (303,676).
\3\ Based on the CDC estimate of 12,816 repeat-donor repeatedly reactive donations per year.
2. Effects on Beneficiaries
Timely notification of HCV infection benefits beneficiaries, both
directly and indirectly, in several important ways. First, although
factors predicting the severity of liver disease due to HCV have not
been well defined, recent data indicate that increased alcohol intake
is associated with more severe liver disease. According to CDC, even
moderate amounts of alcohol in patients with chronic HCV might
exacerbate liver disease. Consequently, an HCV-infected patient
identified by the proposed lookback program could minimize liver damage
associated with alcohol consumption by restricting his or her intake.
Furthermore, while other percutaneous exposures currently represent
the most common means of infection, some case-control studies have also
reported that HCV can be transmitted through sexual contact. In fact,
15 to 25 percent of the acute HCV patients who were reported to CDC's
sentinel counties surveillance system have a history of sexual exposure
in the absence of other risk factors. Infected patients identified
through the proposed lookback procedures could take steps to protect
sexual partners from the risk of infection.
It is also important to note that identified infected patients
would benefit from counseling and treatment with available therapies.
Studies of patient characteristics and responsiveness to therapy
indicate that best results are achieved if treatment is initiated
earlier in the disease, when patients are younger and have not yet
developed cirrhosis.\3\ For example, Bennett et al. estimated the cost
effectiveness of a single course (6 months) of treatment with
interferon alfa and found that patients at age 20 gained an average of
3.1 years of life, at $500 per year of life extended (YLE); 30-year-old
patients gained an average of 1.9 years of life, at $1200/YLE; patients
starting treatment at age 50 gained 6 months of life, at $2900/YLE; and
70-year-old patients gained an average of 22 days, at $62,000/YLE.\4\
---------------------------------------------------------------------------
\3\ G.L. Davis and J.Y.N. Lau, ``Factors Predictive of a
Beneficial Response to Therapy of Hepatitis C,'' Hepatology 26.3
(1997): 122s-126s.
\4\ W.G. Bennett et al., ``Estimates of the Cost-Effectiveness
of a Single Course of Interferon-alfa2b in Patients with
Histologically Mild Chronic Hepatitis C,'' Annals of Internal
Medicine, 127.10 (1997): 855-865.
---------------------------------------------------------------------------
Another benefit of timely notification is that care providers for
the infected patient would be aware of the infection and could use
additional precautions to avoid the risk of exposure to blood or wounds
when providing care.
Finally, infected patients would be informed that they must not
donate blood. The proposed lookback program would, therefore, help to
ensure the safety and continued availability of the national blood
supply.
3. Effects on Medicaid and Medicare Programs
We expect this proposed rule to generate a one-time cost to develop
procedures for recipient notification. We estimate that this cost will
be less than $5 million. Finally, the total one-time cost for the
development of HCV lookback procedures and for recipient notification
associated with the review of historical testing records is estimated
to be $52,653,004 ($2,546,464 + $50,106,540). These one-time costs
would likely be distributed among health programs as follows: Medicare,
33.3 percent; private health insurance, 30.5 percent; Federal Medicaid,
9.8 percent; State Medicaid, 5.8 percent; other private funds, 7.9
percent; other Federal funds, 6.9 percent; and other State and local
funds, 5.7 percent. The total Federal distribution would be 50 percent;
that is, 33.3 percent for Medicare, 9.8 percent for Medicaid, and 6.9
percent for other Federal sources. The degree to which the Federal
programs fund these amounts will vary: Medicaid providers may be able
to pass on costs through the States depending on the method of payment
the State Medicaid program has adopted, while Medicare payments could
be limited because of the hospital outpatient prospective payment
system and increase only in accordance with specific rules regarding
coverage of HCV testing for patients who have been exposed to HCV-
infected blood, including those identified through the FDA lookback
process.
It is important to note that, although this proposed rule presents
the costs that would be imposed on all payers of hospital services,
including the Medicare and Medicaid programs, it merely conforms to the
FDA's proposed rule and has no additional economic impact. It simply
repeats the analysis performed in the FDA companion rule
[[Page 69422]]
and presents the same total costs to hospitals.
C. Alternatives Considered
The PHS Advisory Committee discussed improvements in the treatment
and management of HCV infection and improvements in testing for the HCV
antibody at public meetings held in April and August 1997. The Advisory
Committee recommended that blood establishments and hospitals notify
previous recipients of blood components from donors who tested positive
for HCV upon a subsequent donation.
Following the Department of Health and Human Services' acceptance
of recommendations from the PHS Advisory Committee, FDA developed
industry guidelines for testing blood for HCV, quarantining blood and
blood products, and notifying patients who may have received HCV-
infected blood and blood products. We explored the possibility of using
a program memorandum to notify hospitals that they are required to
follow FDA guidelines. We believe, however, that we should promulgate
an enforceable regulation.
The following discussion considers some key elements of successful
lookback efforts, describes certain challenges identified in lookback
programs already in operation, and reviews the value of targeted
recipient notification and treatment efforts.
The lookback provisions of the proposed rule can be characterized
as a ``targeted lookback'' program, meaning that the notification of
infection risk is limited to, or targeted at, individuals identified as
recipients of blood from donors subsequently found to be infected with
HCV. This program is distinct from ``general lookback'' programs, which
are aimed at all patients who received blood before the onset of
screening and which include the recommendation that the patients be
tested for evidence of infection. General and targeted lookback
programs may be complementary. General lookback can be conducted in a
variety of ways, including use of the broadcast media, education, and
letter campaigns addressed to physicians or patients. By contrast,
targeted lookback can only be performed successfully if the transfusion
service is aware that the donor subsequently tested positive, if donor
and product disposition records are available to link blood components
with the identified donors, and if the physician or hospital knows the
recipient's current whereabouts. Hospitals would locate recipient
records for all transfused units from an affected donor and would have
current recipient or physician address information available so that
the hospitals could deliver notifications. Ideally, the recipient would
still be alive and would respond to the notification for testing and
treatment, if appropriate.
However, recent experiences among Canadian facilities implementing
HCV lookback suggest that the effectiveness of targeted lookback may
vary depending on the extent to which conditions for success exist
within a community. For example, an analysis of targeted lookback in
Quebec province found that, because the records were inadequate or the
whereabouts of recipients were unknown, hospitals could provide
information on only approximately 50 percent of the components
involved.\5\ A Canadian Red Cross Center in Toronto reported on another
lookback challenge. Although the establishment was able to identify
5,301 affected components, trace 3,209 of those to hospitals, obtain
responses for 2,807 (87 percent) of the units, and identify 2,437 as
having been transfused, 45 percent of the transfused patients had
already died. Of those remaining, the Canadian facilities finally
tested only 184 patients (8 percent of the transfused patients) as a
result of the lookback effort although as many as 68 percent of those
tested were found to be HCV positive.\6\
---------------------------------------------------------------------------
\5\ M. Goldman et al., ``Hepatitis C Lookback,'' Transfusion
Medicine Review 12.2 (1998): 84-93.
\6\ A. Wall et al., ``Hepatitis C Virus (HCV) Targeted Lookback
Program,'' Transfusion 37 (1997): 392s.
---------------------------------------------------------------------------
Despite the difficulties of implementing targeted lookback, it is
considered a valuable means of reaching patients at high risk for HCV.
For example, a comparison of Canadian efforts in targeted lookback with
general lookback through physician and public education found that a
large number of patients and families were unaware of the transfusion
episode. These recipients would not have been reached through the
general lookback effort.\7\
---------------------------------------------------------------------------
\7\ M. Goldman et al., ``Hepatitis C Lookback,'' Transfusion
Medicine Review 12.2 (1998): 84-93.
---------------------------------------------------------------------------
Timely notification is important because studies of patient
characteristics and responsiveness to therapy indicate that the best
results are achieved if patients receive treatment when they are
younger and have not yet developed cirrhosis.\8\ The primary treatment
for chronic HCV is alfa interferon therapy.\9\ Of those patients who
undergo interferon treatment, a reported 10 to 20 percent show a
sustained response (SR) after 6 months of therapy, and 20 to 30 percent
show an SR if therapy is continued for 12 months. However, alfa
interferon produces a wide array of adverse side effects,\10\ and some
patients experience a relapse after therapy. Still, the benefits for
patients identified for treatment through HCV lookback are likely to
continue to increase as improved therapies are developed. For example,
recent reports based on pilot studies and completed randomized
controlled trials indicate that the combination of interferon alfa and
ribavirin leads to higher virological SR rates (40 to 50 percent) than
interferon alfa alone, which was administered in 6-month clinical
trials.\11\ FDA has recently approved the use of this combination
therapy for HCV patients who suffer a relapse after initial therapy
with interferon alone.
---------------------------------------------------------------------------
\8\ G.L. Davis and J.Y.N. Lau, ``Factors Predictive of a
Beneficial Response to Therapy of Hepatitis C,'' Hepatology 26.3
(1997): 122s-126s.
\9\ A. Wall et al., ``Hepatitis C Virus (HCV) Targeted Lookback
Program,'' Transfusion 37 (1997): 392s.
\10\ G. Duscheiko, ``Side Effects of Alpha interferon in Chronic
Hepatitis C,'' Hepatology 26.3 (1997): 112s-119s.
\11\ National Institutes of Health (NIH) Consensus Development
Conference Panel Statement: Management of Hepatitis C, Hepatology
26.3 (1997): 2s-10s.
---------------------------------------------------------------------------
As discussed in section I of this document, the BPAC and PHS
Advisory Committee have met a number of times to discuss HCV testing
and other issues related to ``HCV lookback.'' The PHS Advisory
Committee made recommendations after considering alternative procedures
to notify transfusion recipients. Alternative approaches for lookback
are available but are not considered fully effective. Because of the
importance of a safe national blood supply and because our mission is
to protect the public health, we accepted the recommendations of the
PHS Advisory Committee and did not select an alternative approach.
D. Conclusion
In addition to the prospective HIV lookback that hospitals are
currently required to perform, hospitals would be required to conduct a
lookback of transfusion recipients of potentially HCV-infected blood.
This proposed rule would also require hospitals to have in their
agreements with blood banks that blood banks notify hospitals after
performing the FDA-mandated lookback. Therefore, we have prepared a
voluntary analysis consistent with the analysis set forth by the RFA.
We solicit public comments on the extent that any of the entities would
be significantly economically affected by these provisions.
[[Page 69423]]
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by OMB.
We have reviewed this proposed rule under the threshold criteria of
Executive Order 13132, Federalism. We have determined that it would not
significantly affect the rights, roles, and responsibilities of States.
List of Subjects in 42 CFR Part 482
Grant programs--health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, 42 CFR part
482 would be amended as set forth below:
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).
2. In Sec. 482.27, the designation for paragraph (a) is removed;
paragraphs (b) and (c) are redesignated as paragraphs (a) and (b),
respectively; redesignated paragraph (b) is revised; and a new
paragraph (c) is added to read as follows:
Sec. 482.27 Condition of participation: Laboratory services.
* * * * *
(b) Standard: Potentially infectious blood and blood products--(1)
Definition. Potentially human immunodeficiency virus (HIV) infectious
blood and blood products are prior collections from a donor--
(i) Who tested negative at the time of donation but tests
repeatedly reactive for the antibody to HIV on a later donation;
(ii) Who tests positive on the FDA-licensed, more specific test or
other followup testing required by FDA; and
(iii) For whom the timing of seroconversion cannot be precisely
estimated.
(2) Definition. Potentially hepatitis C virus (HCV) infectious
blood and blood products are prior collections from a donor--
(i) Who tested repeatedly reactive for evidence of HCV infection on
a single antigen screening test with a signal to cut off value equal to
or greater than 2.5 for at least two of the three enzyme linked
immunosorbent assay (EIA) tests, or the signal to cut off value cannot
be calculated, and with no record of further testing;
(ii) Who tests or tested repeatedly reactive for evidence of HCV
infection and positive on a multiantigen supplemental test licensed at
an earlier or later date by FDA;
(iii) Who tested repeatedly reactive for evidence of HCV infection
and indeterminate on a supplemental test for HCV, unless an
indeterminate recombinant immunoblot assay (RIBA) 3.0 supplemental test
result was obtained or a negative EIA 3.0 or negative RIBA 3.0 test
result was subsequently obtained;
(iv) Who tested repeatedly reactive for evidence of HCV infection
on a multiantigen screening test with no record of further testing; or
(v) Who tested repeatedly reactive for evidence of HCV infection on
a single antigen screening test and repeatedly reactive on a subsequent
multiantigen screening test, unless a negative supplemental test result
or an indeterminate RIBA 3.0 supplemental test result was obtained.
(3) 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 notify the hospital--
(i) Within 3 calendar days if the blood bank 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 or
HCV on a later donation or who is determined to be at increased risk
for transmitting HIV or HCV infection;
(ii) Within 45 days of the test, of the results of the FDA-
licensed, more specific test for HIV or HCV, as relevant, or other
followup testing required by FDA; and
(iii) Within 3 calendar days if the blood bank supplied blood and
blood products collected from a donor, whenever records are available,
as set forth in FDA's 21 CFR 610.48(h)(3)(ii) and (i)(3)(ii), in
instances in which the donor--
(A) Tested repeatedly reactive on the screening test and positive
on a supplemental test for HCV performed on the repeatedly reactive
sample;
(B) Tested repeatedly reactive on the screening test and
indeterminate on a supplemental test for HCV; or
(C) Tests repeatedly reactive on the screening test with no record
of a supplemental test for HCV performed on the repeatedly reactive
sample and no record of a negative licensed screening test performed on
the same donor.
(4) Quarantine and disposition of blood and blood products pending
completion of testing. If the blood bank (either internal or under an
agreement) notifies the hospital of the repeatedly reactive HIV or HCV
screening test results, 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 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 required by
FDA is positive, the hospital must--
(A) Dispose of the blood and blood products; and
(B) Notify the transfusion recipients as set forth in paragraph
(b)(6) of this section.
(iii) If the blood bank notifies the hospital that the result of
the FDA-licensed, more specific test or other followup testing required
by FDA is indeterminate, the hospital must destroy or label prior
collections of blood or blood products held in quarantine as set forth
in FDA's 21 CFR 610.48(k).
(5) Recordkeeping by the hospital. The hospital must maintain--
(i) Adequate records of the source and disposition of all units of
blood and blood products for at least 10 years from the date of
disposition;
(ii) The records in a manner that permits prompt retrieval; and
(iii) A fully funded plan to transfer these records to another
hospital or other entity if the former hospital ceases operation for
any reason.
(6) Patient notification. If the hospital has administered
potentially HIV or HCV infectious blood or blood products (either
directly through its own blood bank or under an agreement) or released
the blood or blood products to another entity or individual, the
hospital must take the following actions:
(i) Make at least three attempts to notify the patient, or to
notify the attending physician or the physician who ordered the blood
or blood product and ask the physician to notify the patient, that
potentially HIV or HCV infectious blood or blood products were
transfused to the patient.
(ii) Immediately notify the patient, or other individual as
permitted under paragraph (b)(10) of this section, of the need for HIV
or HCV testing and counseling.
(iii) If the physician is unavailable or declines to make the
notification, make at least three attempts to give this
[[Page 69424]]
notification to the patient or other individual.
(iv) Document in the patient's medical record the notification or
attempts to give the required notification.
(7) Timeframe for notification. (i) For donors tested on or after
[effective date of final regulation]. For notifications resulting from
donors tested on or after [effective date of final regulation] as set
forth in FDA's 21 CFR 610.48(a)(b), the notification effort begins when
the blood bank notifies the hospital that it received potentially HIV
or HCV infectious blood and blood products and continues for 12 weeks
unless--
(A) The patient is located and notified; or
(B) 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 12
weeks.
(ii) For donors tested before [effective date of final regulation].
For notifications resulting from donors tested before [effective date
of final regulation] as set forth in FDA's 21 CFR 610.48(c)(d), the
notification effort begins when the blood bank notifies the hospital
that it received potentially HCV infectious blood and blood products.
The hospital must make at least three attempts to give notification and
must complete the actions within 1 year of the date on which the
hospital received notification from the outside blood service.
(8) Content of notification. The notification must include the
following information:
(i) A basic explanation of the need for HIV or HCV testing and
counseling.
(ii) Enough oral or written information so that the transfused
patient can make an informed decision about whether to obtain HIV or
HCV testing and counseling.
(iii) A list of programs or places where the patient can obtain HIV
or HCV testing and counseling, including any requirements or
restrictions the program may impose.
(9) 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 the
confidentiality of medical records and other patient information.
(10) 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. If the patient is a minor, the legal guardian must be
notified.
(c) General blood safety issues. Hospitals must comply with
regulations of the FDA as they pertain to blood safety issues in the
following areas:
(1) Appropriate testing and quarantining of infectious blood and
blood products.
(2) Notification and counseling of recipients that may have
received infectious blood and blood products.
Authority: Sections 1818(d)(2) and 1818A(d)(2) of the Social
Security Act (42 U.S.C. 1395i-2(d)(2) and 1395i-2a(d)(2)).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance)
Dated: September 22, 1999.
Michael M. Hash,
Deputy Administrator, Health Care Financing Administration.
Dated: March 27, 2000.
Donna E. Shalala,
Secretary.
[FR Doc. 00-28908 Filed 11-15-00; 8:45 am]
BILLING CODE 4120-01-P