[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