Medicare Program; Standards for Quality of Water Used in Dialysis and Revised Guidelines on Reuse of Hemodialysis Filters for End-Stage Renal Disease Patients

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 405

[BPD-766-P]

RIN 0938-AG21

Medicare Program; Standards for Quality of Water Used in Dialysis

and Revised Guidelines on Reuse of Hemodialysis Filters for End-Stage

Renal Disease Patients

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

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would revise the conditions for coverage of

suppliers of end-stage renal disease services to incorporate by

reference standards for monitoring the quality of water used in

dialysis as published by the Association for the Advancement of Medical

Instrumentation (AAMI) in ``Hemodialysis Systems'' (2nd Edition). It

would also update an existing incorporation by reference to refer to

the 1993 edition of AAMI's voluntary guidelines on ``Recommended

Practice for Reuse of Hemodialyzers''. These standards and guidelines

contain recognized benchmarks for high quality dialysis procedures.

Section 1881(b)(1)(A) of the Social Security Act authorizes the

Secretary to limit Medicare payment for ESRD services to facilities

meeting the requirements prescribed in regulations.

DATES: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5 p.m. on April

15, 1994.

ADDRESSES: Mail an original and three copies of written comments to the

following address: Health Care Financing Administration, Department of

Health and Human Services, Attention: BPD-766-P, P.O. Box 26676,

Baltimore, MD 21207.

If you prefer, you may deliver your written comments to one of the

following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore,

MD 21207.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code BPD-766-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 309-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: Jacqueline Sheridan, (410) 966-4635

SUPPLEMENTARY INFORMATION:

I. Background

Section 1881 of the Social Security Act (the Act) authorizes

Medicare coverage and payment for the treatment of end-stage renal

disease (ESRD) in approved facilities that provide dialysis and

transplantation services to ESRD patients. The Health Care Financing

Administration (HCFA) grants approval of ESRD facilities after a State

survey agency determines that the facility is in compliance with

conditions for coverage of suppliers of ESRD services in 42 CFR part

405, subpart U. Since their initial publication on June 3, 1976 (41 FR

22502), the conditions for coverage have undergone several revisions as

a result of legislation, as well as operating experience, to reflect

evolving medical standards and techniques.

The regulations contain conditions and standards prescribing the

services that must be provided and the qualifications of staff who

provide those services. The decision as to whether a facility complies

with a particular condition for coverage depends on the manner and

degree to which the supplier satisfies the various standards within

each condition. A supplier is not in compliance if, after completion of

a survey, a State survey agency determines that the supplier fails to

comply with one or more of the standards within the conditions for

coverage, and the deficiencies are of such character as to limit

substantially the supplier's capacity to furnish adequate care or to

affect adversely the health and safety of patients.

II. Quality of Water Used in Dialysis

Our current regulation governing the quality of water used in

dialysis at Sec. 405.2140(a)(5) requires that water used for dialysis

must be analyzed periodically and treated as necessary to maintain a

continuous supply that is biologically and chemically compatible with

acceptable dialysis techniques. Records of test results and equipment

maintenance are maintained at the facility. This standard was developed

in 1976 and has never been modified.

State agency surveyors have difficulty measuring facility

compliance with the standard due to its lack of specificity. Surveyors

favor a standard that includes specific biological and chemical water

purity levels and user monitoring guidelines that can be applied

consistently during each survey.

Water quality is one of the most important aspects of health and

safety in dialysis. Contaminants in water used to make the dialysis

solution (dialysate) may cause adverse reactions when they enter the

patient's bloodstream. Some chemical contaminants are not normally

harmful when present in usual physiological fluids but can become

dangerous if their concentrations are increased by contaminants in the

water used to make dialysate. If water supplies are biologically or

chemically contaminated, such contaminates may be passed into the

patient during the dialysis session, leading to infection or other

adverse consequences. Limits on bacterial growth in dialysate are

necessary to prevent high bacterial counts associated with pyrogenic

reaction.

After consultation with the Public Health Service and a variety of

professionals in the dialysis industry, we have concluded that

establishing specific, measurable standards regarding the quality of

water used in dialysis would better ensure the health and safety of

Medicare beneficiaries. We propose to incorporate by reference the

water quality standard approved by the Association for the Advancement

of Medical Instrumentation (AAMI) and published in ``Hemodialysis

Systems'' (2nd edition). According to the Public Health Service's

Centers for Disease Control and Prevention, the AAMI standard on water

quality is the only standard available, is accepted by the medical

community, and is already utilized by most facilities. We assume that

using this water quality standard will reduce patient risk. However, we

specifically solicit public comments on the validity of this

assumption. We are also seeking comments on the assumption that the

majority of facilities are already using this standard.

III. AAMI Standard on Hemodialysis Systems

The 1992 AAMI standard, ``Hemodialysis Systems,'' reflects the

collective expertise of a committee of health care professionals, in

conjunction with device manufacturers and government representatives,

to develop a standard of performance for manufacturers that will, at a

minimum, ensure the effective, safe performance of hemodialysis

systems, devices, and related materials. Included in the standard are

specific water quality requirements, including maximum levels of

bacteriological and chemical contamination. Additionally, a guideline

for the device user, with specific emphasis on water purity assurance

and monitoring, is appended to the standard. The standard is outcome-

oriented in that it stipulates only specific biological and chemical

water purity levels and does not restrict the methods used by

facilities to attain and maintain the acceptable levels. We are

interested in comments on whether the outcome measures are appropriate

and whether our assumption that most facilities can meet these

requirements is reasonable.

Each AAMI standard or recommended practice is reviewed at least

every 5 years. These reviews are required because of the constant

changes in medical technology and to clarify or improve existing

guidelines. The AAMI Renal Disease and Detoxification Committee

initiated a thorough review of the standard ``Hemodialysis Systems'' in

1986, recognizing that the technology of hemodialysis had changed in a

number of respects since the standard was originally published in 1982.

Task groups were established in those areas that the committee felt

needed most careful review. As a result of the work of these task

groups and of review by the full committee, a proposed revision of the

standard was prepared. (The allowable levels of chemical contaminants

in dialysis water were not changed.) Following committee balloting and

public review, the second edition of ``Hemodialysis Systems'' was

approved March 16, 1992.

Because AAMI guidelines represent medically acceptable standards

and techniques developed in collaboration with health professionals and

industry representatives, we believe manufacturers and users already

have access to, and are familiar with, the standard. However,

``Hemodialysis Systems'' (2nd Edition) (ANSI/AAMI RD5) may be purchased

from AAMI, 3300 Washington Boulevard, suite 400, Arlington, Virginia

22201-4598. Upon final approval of the incorporation by reference, the

publication will be available for inspection at the HCFA Information

Resource Center, 6325 Security Boulevard, Room G-10-A East High Rise

Building, Baltimore, MD or the Office of the Federal Register, 800

North Capitol Street, NW., suite 700, Washington, DC.

We propose to adopt the water quality requirements contained in

sections 3.2.1--Water Bacteriology and 3.2.2--Maximum Level of Chemical

Contamination, as well as the guidelines for monitoring water purity

contained in sections B1 through B5 of Appendix B of AAMI's standard

``Hemodialysis Systems''. The requirements of these sections are

summarized below.

3.2.1 Water Bacteriology

The water used to prepare dialysate should not have a

total viable microbial count exceeding 200/ml. The manufacturer or

supplier recommends a method of cleaning the equipment to meet this

requirement. The user monitors the water bacteriology of the system

following installation.

The total viable microbial count for the dialysate should

not exceed 2000/ml. The supplier of the dialysate supply system

recommends a method of cleaning the equipment that results in a device

capable of meeting this requirement. The user is responsible for

monitoring the purity of the dialysate.

3.2.2 Maximum Level of Chemical Contaminants

This section includes a table listing the maximum

allowable chemical contaminant levels for the water used to prepare

dialysate. The manufacturer or supplier of the water treatment device

is responsible for recommending a system capable of meeting the

requirements of this section. The physician in charge of dialysis has

the ultimate responsibility for selecting the water treatment system

and is also responsible for monitoring the water.

Appendix B, Sections B1 Through B5: Guideline for Monitoring Purity of

Water Used for Hemodialysis

Appendix B outlines the responsibilities of users of

hemodialysis systems to ensure purity of water used for hemodialysis.

Sections B1 through B5 delineate committee recommendations with respect

to frequency of monitoring water used in dialysis to ensure that the

maximum levels of contaminants specified in section 3.2.1 and 3.2.2 are

not exceeded. These recommendations include:

+ The bacteriology of water and dialysate should be sampled at

least monthly or more frequently to define, solve, and control

problems.

+ The frequency of sampling for chemical contaminants varies from 3

months to 12 months depending on the method of water treatment. Because

chemical contamination can vary widely from month to month, monthly

testing is recommended initially to develop a data base for determining

optimum frequency of testing for each facility. When chloramines are

added municipally to the water supply, the water used to prepare

dialysate should be checked for the presence of chloramines at least

once a day.

+ Maximum levels of organic chemicals, pesticides, herbicides, and

radioactive material cannot be specified at present, therefore,

frequency of testing for these materials cannot be established.

+ Frequency of disinfection of the water treatment and disinfection

system, dialysis machines, and equipment used to distribute and prepare

dialysate should be determined by the results of microbiological

monitoring, by any requirements to meet AAMI standards and/or

guidelines, and by the manufacturer's recommendations.

IV. Reuse of Hemodialyzers

Section 1881(f)(7) of the Act requires the Secretary to establish

protocols for reuse of hemodialyzers for those facilities that

voluntarily elect to reuse the filters. In the process of hemodialysis,

the patient's blood is cleansed of impurities by passing the blood

through the filter (hemodialyzer) of a hemodialysis machine. Various

techniques exist that allow these filters to be reused. Reuse involves

cleaning, disinfecting, and preparing disposable hemodialysis devices

for subsequent use for the same patient. Although the potential exists

for adverse patient outcomes from reuse, reprocessing and reuse of

dialyzers are safe when done properly.

On October 2, 1987, through a Federal Register publication (52 FR

36926), final regulations were issued specifying the performance

requirements for reuse of hemodialyzers and other dialysis supplies

(Sec. 405.2150). Section 405.2150 requires ESRD facilities reusing

hemodialyzers to meet the voluntary guidelines and standards adopted by

AAMI and issued in July 1986 as ``Recommended Practice for Reuse of

Hemodialyzers''.

Unlike AAMI ``standards'' which are directed to manufacturers,

``recommended practices'' are directed to health professionals and

provide guidelines for the use, care, and processing of a medical

device or system. The AAMI guidelines on reuse of hemodialyzers are

based on the national consensus of physicians, other health care

professionals, government representatives, patients, and industry. They

describe the details of reprocessing dialyzers and address various

areas such as personnel qualifications and training, patient

considerations, equipment, reprocessing supplies, monitoring during

dialysis, quality assurance, and quality control.

Since the publication of the 1986 edition of the ``Recommended

Practice for Reuse of Hemodialyzers'' and HCFA's adoption of the

recommended practice, users of the guidelines have asked numerous

questions. As a result of the AAMI review of the 1986 guidelines, the

Hemodialyzer Reuse Subcommittee of the AAMI Renal Disease and

Detoxification Committee developed a 1993 edition. The subcommittee

consists of representatives from the manufacturing, governmental

(including HCFA), physician, dialysis facility, and patient consumer

communities.

The preliminary revisions underwent concurrent public review and

committee balloting which lasted 2 months. The final revisions also

underwent public review and committee balloting and were approved May

3, 1993. A quorum of two-thirds of the subcommittee was necessary to

vote the document's approval.

The announcement of the 1993 edition of ``Recommended Practice for

Reuse of Hemodialyzers'' was made in the ``AAMI News'', the ``American

National Standards Institute Reporter'', and in press releases to 500

trade journals. The 1993 edition (ANSI/AAMI RD47) may be purchased from

AAMI, 3300 Washington Boulevard, suite 400, Arlington, Virginia 22201-

4598. Upon final approval of the incorporation by reference, the 1993

edition will be available for inspection at the HCFA Information

Resource Center, 6325 Security Boulevard, Room G-10-A East High Rise

Building, Baltimore, MD 21207, or the Office of the Federal Register,

800 North Capitol Street, NW., suite 700, Washington, DC.

The 1993 edition is directed to the physician in charge of

hemodialyzer reprocessing by either the manual or automated method and

describes the essential elements of good practices for reprocessing

dialyzers to help assure device safety and effectiveness. Some of the

salient changes included in the document are:

New Occupational Safety and Health Administration (OSHA)

recommended environmental exposure limits of chemicals;

Significant simplification and clarification of the

process of validating indirect performance measurements;

A new section on equipment safety that recommends testing

the function of the reprocessing system after repair of automated

equipment unless a system has an autotest mode;

A definition for ``rebound'' that describes the

disinfectant rebound effect;

Revisions regarding use, testing, and removal of chemical

germicide and more detailed specifications on germicides involved in

reuse;

An expanded section on safety monitoring of clinical test

results;

Several new bibliographical references;

Appendices that list the rationales for the revised

sections and include a new basic formaldehyde assay test method; and

Revised requirements for personnel qualifications and

training, patient considerations, water and reprocessing equipment.

V. Provisions of the Proposed Regulations

We propose to revise Sec. 405.2140(a)(5) to require that ESRD

facilities meet the AAMI standards on water quality found in sections

3.2.1, 3.2.2, and B1-B5 of Appendix B of ``Hemodialysis Systems'' (2nd

Edition) which would be incorporated by reference. We would indicate

that copies of this publication may be purchased from AAMI and are

available for inspection at the HCFA Information Resource Center or the

Office of the Federal Register.

In Sec. 405.2150(a)(1), we propose to require ESRD facilities

reusing hemodialyzers to meet the 1993 edition of the AAMI guidelines

on ``Recommended Practice for Reuse of Hemodialyzers'' which we propose

to incorporate by reference. We would indicate that copies of the 1993

edition may be purchased from AAMI and are available for inspection at

the HCFA Information Resource Center or the Office of the Federal

Register.

We would remove Sec. 405.2150(a)(2) concerning staff exposure to

chemical germicides, paragraph (a)(3)(iii) concerning reporting adverse

patient reactions to the manufacturer; and paragraph (b) concerning the

standard for dialyzer caps. These topics are covered in the following

sections of the revised 1993 AAMI guidelines which would be

incorporated by reference:

Section 8--Physical plant and environmental safety

considerations

Section 11--Reprocessing

Section 13--Monitoring

Annex A--Section A11.4--Germicide.

VI. Response to Comments

Because of the large number of items of correspondence we normally

receive on a proposed rule, we are not able to acknowledge or respond

to them individually. However, we will consider all comments that we

receive by the date and time specified in the DATES section of this

preamble, and if we proceed with the final rule, we will respond to the

comments in the preamble to the final rule.

VII. Collection of Information Requirements

This rule contains no information collection requirements.

Consequently, this rule need not be reviewed by the Office of

Management and Budget under the authority of the Paperwork Reduction

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

VIII. Regulatory Impact Statement

A. Introduction

We generally prepare a regulatory flexibility analysis that is

consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612) unless the Secretary certifies that a proposed rule would

not have a significant economic impact on a substantial number of small

entities. For purposes of the RFA, all ESRD facilities are considered

to be small entities.

Also, section 1102(b) of the Act requires the Secretary to prepare

a regulatory impact analysis if a proposed rule may have a significant

impact on the operations of a substantial number of small rural

hospitals. 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.

In accordance with the provisions of Executive Order 12866 this

proposed rule was reviewed by the Office of Management and Budget.

B. Water Quality Standards

The proposed rule would incorporate into regulations existing

industry standards on the quality of water used in dialysis to enable

surveyors to accurately assess a facility's compliance with the

standard on water quality. The AAMI standards are the result of a

collaborative effort by health professionals and industry

representatives to respond to clinical needs and to help ensure patient

health and safety. It is our understanding that AAMI's recommended

maximum levels for water contaminants have been clearly defined and

supported by scientific literature and developed through industry

consensus. Under the AAMI water standard, the supplier/manufacturer of

dialysis water treatment equipment is responsible for assuring that the

water produced by the system routinely does not exceed the maximum

allowable chemical contaminant levels. Because AAMI's acceptable

contamination levels have been in effect since 1982 and are recognized

as medically acceptable standards, we believe that manufacturers have

been producing, and facilities purchasing, equipment capable of meeting

these requirements. We understand that technology is in place for all

facilities to meet the AAMI water standard and solicit comments on this

understanding. While variations in water quality do typically occur,

any changes that occur will be handled through consultation with State

and local water authorities and safe purity levels ensured through

continued monitoring by the physician in charge of dialysis. Although

contaminants in water used in dialysate may cause adverse patient

reactions, actual documented adverse incidents are rare when water is

monitored properly. Because the AAMI water quality standard represents

long-standing acceptable medical practice, we believe the vast majority

of facilities already comply with this standard. Incorporation of the

AAMI standard into regulations will help ensure patient health and

safety by providing surveyors with a measurable standard with which

they may assess facility compliance, especially in the few facilities

that do not voluntarily conform to the water quality guidelines adopted

by the industry.

C. Reuse of Hemodialyzers

The AAMI ``Recommended Practice on Reuse'' does not promote either

single use or reuse of dialyzers. The guidelines were developed to

acknowledge the widespread practice of reprocessing and provide

recommendations for optimal hemodialyzer reprocessing. In January 1993,

HCFA's Health Standard and Quality Bureau canvassed the 2,345 Medicare

certified ESRD facilities to determine if they practiced reuse, and if

so, the disinfecting protocols used. Sixty-five percent (1,532) of the

facilities reported practicing reuse. Of these facilities,

approximately 51 percent use renalin as the germicide, with two-thirds

of these facilities using an automated disinfecting system.

Approximately 40 percent of the facilities reported using formalin/

formaldehyde as the germicide, with manual and automated systems

receiving equal use. Approximately 9 percent of the facilities

practicing reuse reported using glutaraldehyde as the germicide, with

the majority of these facilities using an automated disinfecting

system. Less than 1 percent of the facilities use other disinfecting

methods.

Because the 1993 AAMI guidelines do not differ significantly from

the 1986 guidelines (which all Medicare participating facilities

practicing reuse already must meet), we believe that the great majority

of the facilities practicing reuse would be in compliance with the new

standards proposed in this regulation. The 1993 AAMI standards were

developed through a public forum and their adoption was well

publicized. They reflect the most up-to-date reuse procedures already

practiced by many of the facilities, and we do not believe that

incorporating the 1993 guidelines into our regulations, in and of

itself, would prompt any facility to begin or discontinue reuse.

We expect that each facility would respond to these new standards

based on the relationship of these standards to its current reuse

practices and to factors such as whether or not a facility presently

meets the standards or can meet them without extensive changes, and

whether or not the facility can buy new filters in quantity less

expensively than it can upgrade its reuse practices. As we said above,

65 percent of the facilities are already reusing dialyzers. The major

effect of this proposed rule would be to assure that Medicare standards

for reuse reflect safe and effective practices.

D. Conclusion

Because we are unable to predict the decisions facilities would

make in response to this regulation, we are unable to quantify the

potential effect it would have. Some beneficiaries may be reassured

that HCFA has adopted specific water quality standards and updated its

standards for reuse of hemodialyzers to ensure their health and safety.

However, we expect that there would be a negligible effect on most

beneficiaries and facilities since we believe these revisions would

make no major changes in current facility operation or patient

experience. This proposed rule is not expected to result directly in

any increases or reductions in Medicare program expenditures.

For these reasons, we have determined, and the Secretary certifies

that this proposed rule would not have a significant economic impact on

a substantial number of small entities and would not have a significant

economic impact on the operations of a substantial number of small

rural hospitals. Therefore, we are not preparing analyses for either

the RFA or section 1102(b) of the Act.

List of Subjects in 42 CFR Part 405

Administrative practice and procedure, Health facilities, Health

professions, Incorporation by reference, Kidney diseases, Medicare,

Reporting and recordkeeping requirements, Rural areas, X-rays.

42 CFR chapter IV, part 405, subpart U would be amended as set

forth below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

A. The authority citation for part 405, subpart U continues to read

as follows:

Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, and 1881 of

the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh,

1395kk, and 1395rr), and sec. 353 of the Public Health Service Act

(42 U.S.C. 263a), unless otherwise noted.

B. In Sec. 405.2140, the heading of paragraph (a) is republished,

and paragraph (a)(5) is revised to read as follows:

Sec. 405.2140 Condition: Physical environment.

* * * * *

(a) Standard: Building and equipment. * * *

(5)(i) The ESRD facility must employ the water quality requirements

listed in paragraph (a)(5)(ii) of this section developed by the

Association for the Advancement of Medical Instrumentation (AAMI) and

published in ``Hemodialysis Systems'' (2nd edition) which is

incorporated by reference.

(ii) Required water quality requirements are those listed in

sections 3.2.1, Water Bacteriology; 3.2.2, Maximum Level of Chemical

Contaminants; and in Appendix B: Guideline for Monitoring Purity of

Water Used for Hemodialysis as B1 through B5.

(iii) Incorporation by reference of the Association for the

Advancement of Medical Instrumentation's ``Hemodialysis Systems'' (2nd

edition) (ANSI/AAMI RD5-1992) was approved by the Director of the

Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

This publication is available for inspection at the HCFA Information

Resource Center, 6325 Security Boulevard, Room G-10-A East High Rise

Building, Baltimore, MD 21207 and the Office of the Federal Register,

800 North Capitol Street, NW., suite 700, Washington, DC. Copies may be

purchased from AAMI, 3300 Washington Boulevard, suite 400, Arlington,

VA 22201-4598. If any changes in ``Hemodialysis Systems'' (2nd edition)

are also to be incorporated by reference, a document to that effect

will be published in the Federal Register.

* * * * *

C. In Sec. 405.2150, the undesignated introductory text and

paragraph (a) are revised, paragraph (b) is removed, paragraphs (c) and

(d) are redesignated as paragraphs (b) and (c), respectively, and

redesignated paragraph (c)(1) is revised to read as follows:

Sec. 405.2150 Condition: Reuse of hemodialyzers and other dialysis

supplies.

An ESRD facility that reuses hemodialyzers and other dialysis

supplies meets the requirements of this section. Failure to meet any of

paragraphs (a) through (c) of this section constitutes grounds for

denial of payment for the dialysis treatment affected and termination

from participation in the Medicare program.

(a) Standard: Hemodialyzers. If the ESRD facility reuses

hemodialyzers, it conforms to the following:

(1) Reuse guidelines. Voluntary guidelines adopted by the

Association for the Advancement of Medical Instrumentation (A.A.M.I.)

1993 edition (i.e., ``Recommended Practice for Reuse of

Hemodialyzers''). Incorporation by reference of the Association for the

Advancement of Medical Instrumentation 1993 edition of the

``Recommended Practice for Reuse of Hemodialyzers'' (ANSI/AAMI RD47)

was approved by the Director of the Federal Register in accordance with

5 U.S.C. 552(a) and 1 CFR part 51. This publication is available for

inspection at the HCFA Information Resource Center, 6325 Security

Boulevard, Room G-10-A East High Rise Building, Baltimore, MD 21207 and

the Office of the Federal Register, 800 North Capitol Street, NW.,

suite 700, Washington, DC. Copies may be purchased from AAMI, 3300

Washington Boulevard, Suite 400, Arlington, VA 22201-4598. If any

changes in the ``Recommended Practice for Reuse of Hemodialyzers'' are

also to be incorporated by reference, a document to that effect will be

published in the Federal Register.

(2) Procedure for chemical germicides. To prevent any risk of

dialyzer membrane leaks due to the combined action of different

chemical germicides, dialyzers are exposed to only one chemical

germicide during the reprocessing procedure. If a dialyzer is exposed

to a second germicide, the dialyzer must be discarded.

(3) Surveillance of patient reactions. In order to detect

bacteremia and to maintain patient safety when unexplained events

occur, the facility--

(i) Takes appropriate blood cultures at the time of a febrile

response in a patient; and

(ii) If pyrogenic reactions, bacteremia, or unexplained reactions

associated with ineffective reprocessing are identified, terminates

reuse of hemodialyzers in that setting and does not continue reuse

until the entire reprocessing system has been evaluated.

(b) * * *

(c) * * *

(1) Limit the reuse of bloodlines to the same patient;

* * * * *

(Catalog of Federal Domestic Assistance Program No. 93.773,

Medicare--Hospital Insurance; and Program No. 93.774, Medicare--

Supplementary Medical Insurance Program)

Dated: September 23, 1993.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: October 23, 1993.

Donna E. Shalala,

Secretary.

[FR Doc. 94-3307 Filed 2-11-94; 8:45 am]

BILLING CODE 4120-01-P