[Federal Register Volume 65, Number 222 (Thursday, November 16, 2000)]
[Proposed Rules]
[Pages 69416-69424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28908]


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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:
    <bullet> Whether the information collection is necessary and useful 
to carry out the proper functions of the agency;
    <bullet> The accuracy of the agency's estimate of the information 
collection burden;
    <bullet> The quality, utility, and clarity of the information to be 
collected; and
    <bullet> 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