69416 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules

Dated: December 3, 1999.

Jane E. Henney,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 00–28907 Filed 11–15–00; 8:45 am]

BILLING CODE 4160–01–F

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.

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 § 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

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules 69417

1M.J. Alter, ‘‘Epidemiology of Hepatitis C,’’

Hepatology 26.3 (1997): 62s–65s.

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

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 transfusiontransmitted 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 longterm 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 HCVinfected 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 (AntiHCV).’’ 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

69418 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules

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

§ 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 § 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 § 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

§ 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 § 482.27(b)(3).) In addition, we

would revise our regulations to include

HCV-relevant testing required by FDA.

(See proposed § 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 § 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 § 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 § 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 § 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 § 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

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules 69419

recipients that may have received

infectious blood and blood products.

Note that our Medicaid regulations at

§ 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 § 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, § 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, § 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, § 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

§§ 482.27(b)(6), (b)(7), and (b)(8).

In summary, § 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, § 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.

69420 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules

2Richard Quattrocchi, Home Access Health

Corporation.

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 § 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 × $165) for

hospitals to conduct prospective

lookback activities. (See Table in this

section.)

For notifications resulting from

donors tested before the effective date of

the final rule under FDA’s proposed

§ 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

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules 69421

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.

4W.G. Bennett et al., ‘‘Estimates of the CostEffectiveness of a Single Course of Interferon-alfa2b

in Patients with Histologically Mild Chronic

Hepatitis C,’’ Annals of Internal Medicine, 127.10

(1997): 855–865.

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

Type of cost Total one-time

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

1Based on 6,200 hospitals.

2Based on the CDC estimate of the total number of blood products (303,676).

3Based 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 HCVinfected 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

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 onetime 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

69422 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules

5M. Goldman et al., ‘‘Hepatitis C Lookback,’’

Transfusion Medicine Review 12.2 (1998): 84–93.

6A. Wall et al., ‘‘Hepatitis C Virus (HCV) Targeted

Lookback Program,’’ Transfusion 37 (1997): 392s.

7M. Goldman et al., ‘‘Hepatitis C Lookback,’’

Transfusion Medicine Review 12.2 (1998): 84–93.

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.

9A. 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.

11National Institutes of Health (NIH) Consensus

Development Conference Panel Statement:

Management of Hepatitis C, Hepatology 26.3 (1997):

2s–10s.

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

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

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.

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.

Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules 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 § 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:

§ 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 FDAlicensed, 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 FDAlicensed, 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 FDAlicensed, 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 FDAlicensed, 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

69424 Federal Register / Vol. 65, No. 222 / Thursday, November 16, 2000 / Proposed Rules

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