[Federal Register Volume 59, Number 30 (Monday, February 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3307]


[[Page Unknown]]

[Federal Register: February 14, 1994]


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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.

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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