[Federal Register: April 15, 2008 (Volume 73, Number 73)]
[Rules and Regulations]
[Page 20369-20484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap08-14]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 413 et al.
Medicare and Medicaid Programs; Conditions for Coverage for End-Stage
Renal Disease Facilities; Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 413, 414, 488, and 494
[CMS-3818-F]
RIN 0938-AG82
Medicare and Medicaid Programs; Conditions for Coverage for End-
Stage Renal Disease Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This rule finalizes the February 4, 2005 proposed rule
entitled ``Medicare Program; Conditions for Coverage for End-Stage
Renal Disease Facilities.'' It establishes new conditions for coverage
that dialysis facilities must meet to be certified under the Medicare
program. This final rule focuses on the patient and the results of care
provided to the patient, establishes performance expectations for
facilities, encourages patients to participate in their plan of care
and treatment, eliminates many procedural requirements from the
previous conditions for coverage, preserves strong process measures
when necessary to promote meaningful patient safety, well-being, and
continuous quality improvement. This final rule reflects the advances
in dialysis technology and standard care practices since the
requirements were last revised in their entirety in 1976.
DATES: The provisions of this final rule are effective October 14,
2008. Compliance with Sec. 494.30(a)(1)(i) and Sec. 494.60(e)(1) is
not required until February 9, 2009. In addition, the compliance with
Sec. 494.180(h) is effective on February 1, 2009. The incorporation by
reference of certain publications listed in the regulations is approved
by the Director of the Federal Register as of October 14, 2008.
FOR FURTHER INFORMATION CONTACT: Lynn Riley, (410) 786-1286, Stefan
Miller, (410) 786-6656, Lauren Oviatt, (410) 786-4683, Judith Kari,
(410) 786-6829, (Survey and Certification), Teresa Casey, (410) 786-
7215, (Issues related to Quality Assessment Performance Improvement).
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Introduction
B. Legislative History
C. Existing ESRD Regulations
D. The Establishment of Central Requirements
II. Summary of the Proposed Provisions and Response to Comments on
the February 4, 2005 Proposed Rule
A. Part 414--Payment for Part B Medical and Other Health
Services; Payment for Home Dialysis Equipment, Supplies, and Support
Services (Proposed Sec. 414.330)
B. Part 488--Survey, Certification, and Enforcement Procedures;
Special Procedures for Approving End-Stage Renal Disease Facilities
(Proposed Sec. 488.60)
C. Part 494--Conditions for Coverage for End-Stage Renal Disease
Facilities
1. Subpart A--General Provisions
a. Basis and Scope (Proposed Sec. 494.1)
b. Definitions (Proposed Sec. 494.10)
c. Compliance With Federal, State, and Local Laws and
Regulations (Proposed Sec. 494.20)
2. Subpart B--Patient Safety
a. Infection Control (Proposed Sec. 494.30)
b. Water and Dialysate Quality (Proposed Sec. 494.40)
c. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
d. Physical Environment (Proposed Sec. 494.60)
3. Subpart C--Patient Care
a. Patients' Rights (Proposed Sec. 494.70)
b. Patient Assessment (Proposed Sec. 494.80)
c. Patient Plan of Care (Proposed Sec. 494.90)
d. Care at Home (Proposed Sec. 494.100)
e. Quality Assessment and Performance Improvement (Proposed
Sec. 494.110)
f. Special Purpose Renal Dialysis Facilities (Proposed Sec.
494.120)
g. Laboratory Services (Proposed Sec. 494.130)
4. Subpart D--Administration
a. Personnel Qualifications (Proposed Sec. 494.140)
b. Responsibilities of the Medical Director (Proposed Sec.
494.150)
c. Relationship With the ESRD Network (Proposed Sec. 494.160)
d. Medical Records (Proposed Sec. 494.170)
e. Governance (Proposed Sec. 494.180)
D. Other Proposed Changes and Issues
1. Proposed Cross-Reference Changes
2. Proposed Additions to Part 488
E. Survey & Certification Comments
F. Impact Analysis Comments
III. Provisions of the Final Rule
IV. Effective Dates for the Final Rule
V. Reference Materials
A. Provisions of Part 494
B. ESRD Crosswalk
VI. Collection of Information Requirement
VII. Regulatory Impact Analysis
Regulations Text
Acronym List
AAMI Association for the Advancement of Medical Instrumentation
ACLS Advanced Cardiac Life Support
ADA American Dietetic Association
AED Automated external defibrillator
AIA American Institute of Architects
AHA American Heart Association
ALT Alanine Aminotransferase
APA Administrative Procedures Act
ANSI American National Standards Institute
BMI Body mass index
BONENT Board of Nephrology Nursing Examiners Nursing and Technology
BSW Bachelor's degree social worker
CADE Commission on Accreditation for Dietetics Education
CAHPS Consumer Assessment of Health Plans Survey
CCHT Certified Clinical Hemodialysis Technician
CDC Centers for Disease Control and Prevention
CEO Chief executive officer
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare and Medicaid Services
CNSW Council of Nephrology Social Workers
CPG Clinical practice guidelines
CPM Clinical performance measures
CRAFT CROWN Responsiveness and Feedback Tree
CROWNWeb Consolidated Renal Operations in a Web-enabled Network
DFC Dialysis Facility Compare
DHHS Department of Health and Human Services
DOPPS Dialysis Outcomes and Practice Patterns Study
DOQI Disease Outcomes Quality Initiative
DTR Dietetic Technician, Registered
EDI Electronic Data Interchange
EMS Emergency medical system
ESRD End-Stage renal disease
FDA Food and Drug Administration
HBsAg Hepatitis B surface antigen
HIPAA Health Insurance Portability and Accountability Act 1996
HBV Hepatitis B virus
HCV Hepatitis C virus
HICPAC Healthcare Infection Control Practices Advisory Committee
HMO Health Maintenance Organization
ICC International Code Council
ICH In-center hemodialysis
IOM Institute of Medicine
KCP Kidney Care Partners
KDOQI Kidney Disease Outcomes Quality Initiative
K/DOQI Kidney Disease Outcomes Quality Initiative
LAL Amoebocyte lysate
LDO Large dialysis organization
LPN Licensed practical nurse
LVN Licensed vocational nurse
LSC Life Safety Code
MedPAC Medicare Payment Advisory Commission
MNT Medical nutrition therapy
MPD Mission and Priority Document
MSW Master's degree social worker
NCD National Coverage Determination
NF Nursing Facility
NKF National Kidney Foundation
NKF-KDOQI National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative
NNCC Nephrology Nursing Certification Commission
NNCO National Nephrology Certification Organization
NQF National Quality Forum
NTTAA National Technology Transfer and Advancement Act of 1995
OIG Office of the Inspector General
PA Physician assistant
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PCT Patient care technician
QAPI Quality assessment and performance improvement
QIS Quality Infrastructure Report
RD Registered dietitian
RN Registered nurse
REMIS Renal Management Information System
RO Reverse osmosis
RPA Renal Physicians Association
SGA Subjective global assessment
SHEA Society for Healthcare Epidemiology of America
SNF Skilled nursing facility
SOW Scope of work
STIC Safe and Timely Immunization Coalition
TEP Technical Expert Panel
VISION Vital Information System to Improve Outcomes in Nephrology
I. Background
A. Introduction
End-Stage Renal Disease (ESRD) is a kidney impairment that is
irreversible and permanent and requires either a regular course of
dialysis or kidney transplantation to maintain life. Dialysis is the
process of cleaning the blood and removing excess fluid artificially
with special equipment when the kidneys have failed. Our existing ESRD
services conditions for coverage were originally adopted in 1976 (41 FR
22502). In our existing requirements for dialysis facilities at 42 CFR
part 405, subpart U, we emphasize the policies and procedures that must
be in place to support good patient care, and we focus on a facility's
capacity to furnish quality care. To determine if a facility meets ESRD
conditions for coverage, the State survey agency performs an on-site
survey of the facility. If a survey indicates that a facility is in
compliance with the conditions, and all other Federal requirements are
met, we then certify the facility as qualifying for Medicare payment.
Medicare payment for outpatient maintenance dialysis is limited to
facilities meeting these conditions. We have made several changes to
our ESRD requirements since they were first adopted in 1976. However,
they have not been comprehensively revised since that time.
On February 4, 2005, we published in the Federal Register a
proposed rule entitled ``Conditions for Coverage for End-Stage Renal
Disease Facilities'' (70 FR 6183). In that rule, we proposed revisions
to the requirements that ESRD dialysis facilities must meet in order to
be certified under the Medicare program.
Our decision to propose major changes to the existing conditions
was based on several considerations. Revising the ESRD requirements is
part of our effort to modernize regulations and improve the
availability of quality-of-care information; to promote transparency;
and to move toward a patient outcome-based system that focuses on
quality assessment and performance improvement. We believe that
revising the conditions for coverage would encourage improvement in
outcomes of care for beneficiaries. We wish to incorporate the most
recent medical and scientific guidelines and recommendations for
dialysis facilities from the Centers for Disease Control and Prevention
(CDC), the Association for the Advancement of Medical Instrumentation
(AAMI), and recognize current practice guidelines and professional
standards of practice such as the National Kidney Foundation's Kidney
Disease Outcomes Quality Initiative (NKF-K/DOQI) clinical practice
guidelines (CPGs).
B. Legislative History
Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-
603) originally extended Medicare coverage to insured individuals,
their spouses, and their dependent children with ESRD who require
dialysis or transplantation. The ESRD program became effective July 1,
1973, and initially operated under interim regulations published in the
Federal Register on June 29, 1973 (38 FR 17210). In the July 1, 1975
Federal Register (40 FR 27782), we published a proposed rule that
revised sections of the ESRD requirements. On June 3, 1976 the final
rule was published in the Federal Register (41 FR 22501). Subsequently,
the ESRD Amendments of 1978 (Pub. L. 95-292), amended title XVIII of
the Social Security Act (the Act) by adding section 1881. Sections
1881(b)(1) and 1881(f)(7) of the Act further authorize the Secretary to
prescribe health and safety requirements (known as conditions for
coverage) that a facility providing dialysis and transplantation
services to dialysis patients must meet to qualify for Medicare
payment. In addition, section 1881(c) of the Act establishes ESRD
Network areas and Network organizations to assure that dialysis
patients are provided appropriate care.
We know, based on comments, that many in the community support the
overall shift in the ESRD conditions for coverage from an emphasis on
process-oriented requirements to a more patient-centered, outcome-
oriented approach. Further, we believe that virtually all members of
the community support a quality assessment and performance improvement
requirement and the development of a comprehensive data set that will
contain information including the characteristics of ESRD facilities,
their patient populations, as well as outcome measures of patient care.
The fundamental principles that guided us during this collaborative
effort to develop new conditions were as follows:
Ensure that patients' rights and physical safety are
protected;
Stress continuous quality assessment and performance
improvement, incorporating, to the greatest extent possible, outcome-
oriented, data-driven measures;
Facilitate flexibility in how dialysis facilities meet our
performance requirements;
Eliminate unnecessary administrative policies. Process-
oriented standards are only included where we believe they are
essential to protect patient health and safety;
Focus on the continuous, interdisciplinary, integrated
care system that a dialysis patient experiences, centered around
patient assessment, care planning, service delivery, and quality
assessment and performance improvement; and
Stress patient satisfaction and ongoing patient
involvement in the development of the care plan and treatment.
Finally, in order for the ESRD facility conditions for
coverage to move from a process and structure orientation toward a more
patient-centered, outcome-oriented approach, individual patient and
facility-specific outcome measures must be identified and evaluated, or
in the absence of existing measures, they must be developed and
validated with community input to ensure they are clinically meaningful
and reflect current scientific knowledge.
C. Existing ESRD Regulation
The requirements from section 1881(b), (c), and (f)(7) of the Act
are implemented in regulations at 42 CFR part 405, subpart U,
``Conditions for Coverage of Suppliers of End-Stage Renal Disease
(ESRD) Services.''
The existing regulations describe the health and safety
requirements that dialysis facilities must meet to furnish care to
Medicare beneficiaries. The regulations in part 405, subpart U also
include the provision that dialysis facilities be organized into
Network areas and describe the role that Networks play in the ESRD
program. Networks are defined at Sec. 405.2110 as ``CMS designated
ESRD Networks in which the approved ESRD facilities collectively
provide the necessary care for ESRD patients.''
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The purpose of the existing conditions for coverage (also known as
conditions) is to protect dialysis patients' health and safety and to
ensure that quality care is furnished to all patients in Medicare-
approved dialysis facilities.
The ESRD conditions for coverage (health and safety provisions for
dialysis facilities) will be moved from existing 42 CFR part 405,
subpart U, to a new 42 CFR part 494, where they will follow regulations
establishing standards for other Medicare providers, such as the
conditions of participation for hospitals (42 CFR part 482), long-term
care facilities (42 CFR part 483), and home health agencies (42 CFR
part 484). The termination of Medicare coverage and alternative
sanctions conditions at Sec. 405.2180 through Sec. 405.2184 will be
recodified at Sec. 488.604 through Sec. 488.610. Since many of the
existing ESRD conditions will be revised, consolidated with other
conditions, or deleted, we are renumbering and reorganizing the
requirements.
D. The Establishment of Central Requirements
Our 2005 proposed rule proposed new conditions for coverage for
ESRD facilities that revise or eliminate many of the existing
requirements and establish critical central requirements. The central
requirements of this rule were grouped into three broad categories: (1)
Patient safety; (2) patient care; and (3) administration. Subpart A
contained general provisions, for example, statutory authority,
definitions, and requirements for compliance with Federal, State and
local laws and regulations. Subpart B (Patient Safety), and subpart C
(Patient Care) of the proposed conditions for coverage focused on the
actual care delivered to the patients, the performance of the dialysis
facility, and the impact of the treatment furnished by the dialysis
facility on the health status of its patients. Subpart D contained
personnel, ESRD Network, medical records and governance requirements.
In subpart B (Patient Safety), we proposed to retain and strengthen
some process-oriented patient safety provisions that we believe remain
highly predictive of ensuring desired outcomes and preventing harmful
outcomes. Accordingly, the proposed patient safety requirements
incorporated current CDC infection control procedures, retained and
updated our incorporation by reference of the AAMI standards and
guidelines for water quality and dialysate, hemodialyzer reuse
practices, and incorporated by reference applicable current Life Safety
Code (LSC) provisions.
Subpart C (Patient Care) included provisions: (1) Emphasizing a
dialysis facility's fundamental responsibility to respect and promote
the rights of each patient (patient rights); (2) requiring a facility
to perform a comprehensive assessment to determine appropriate
treatments and achieve desired health outcomes (Patient Assessment);
(3) requiring an interdisciplinary team approach to providing dialysis
services to patients; and specifying the process by which the
interdisciplinary team would achieve effective patient health outcomes
(Patient Plan of Care); (4) requiring a quality assessment and
performance improvement program which would charge each dialysis
facility with carrying out a program of its own design to continually
improve quality outcomes and patient satisfaction; and (5)
consolidating various aspects of home dialysis care into a single
condition (Care at home).
Subpart D (Administration) covered the operation of the dialysis
facility in a patient outcome-oriented environment, including: (1)
Minimum personnel qualifications; (2) the role of the medical director;
(3) the facility's relationship with its servicing ESRD Network; (4)
medical recordkeeping; and (5) minimum operating responsibilities of
the facility, including data collection and reporting requirements
(Governance).
On August 22, 2006, President Bush signed Executive Order 13410,
entitled ``Promoting Quality and Efficient Health Care in Federal
Government Administered or Sponsored Health Care Programs' (71 FR
51089, August 28, 2006). In order to empower Americans to find better
health care value and better health care, they should know their health
care options in advance. Patients need access to information regarding
the quality of doctors, hospitals, dialysis facilities and other
providers in their area, as well as the costs of various medical
procedures. The August 2006 executive order directs agencies to
increase transparency in pricing by sharing pricing information with
patients; to increase transparency in quality by sharing information
with patients on the quality of services provided by doctors,
hospitals, ESRD facilities, and other health care providers; to
encourage the adoption of health information technology systems that
meet recognized interoperability standards; and to provide patients
with options that promote quality and efficiency in health care, by
developing and identifying approaches that facilitate high quality and
efficient care. Building on efforts of quality alliances that include a
broad range of healthcare stakeholders, we will work collaboratively to
improve quality and cost information. Patients will be able to access
this information from a variety of potential sources, including
insurance companies, employers, and Medicare sponsored Web sites. In
order to help dialysis patients make more informed health care
decisions and to increase transparency, this final rule promotes a
patient-centered approach and focuses on disclosing relevant
information regarding care to patients.
We believe that transparency will also be improved by the
implementation of an electronic Web-based data collection system,
Consolidated Renal Operations in a Web-enabled Network (CROWNWeb),
which is designed to collect clinical performance measures (CPMs) data
from dialysis facilities. CPM data are used to monitor the performance
of Medicare-certified dialysis facilities on a national and local
level. These data are also used to provide information to individuals
who have or may develop ESRD and their caregivers to assist them in
making health care decisions; to allow the identification of
opportunities for quality improvement at a national, regional, or
dialysis facility-level; and to calculate case-mix adjustments and the
potential future use of value based purchasing.
Dialysis Facility Compare (DFC) is an online tool at http://
www.medicare.gov available for dialysis patients and their caregivers,
which serves to enhance public accountability in healthcare by
increasing transparency regarding the quality of dialysis facility
care. DFC allows patients and caregivers to find and compare
information about the services and quality of care provided at dialysis
facilities in any State. Important information and resources regarding
chronic kidney disease is also available on the DFC Web site.
II. Summary of the Proposed Provisions and Response to Comments on the
February 4, 2005 Proposed Rule
The comment period for the February 4, 2005 proposed rule was 90
days, and closed on May 5, 2005. We received over 3,000 public
comments, but many were form letters, so that the total number of
discrete comments was approximately 315. Interested parties that
commented included the American Association of Kidney Patients, the
American Kidney Fund, the American Nephrology Nurses Association, the
American Society of Nephrology, the American Healthcare Association,
the Association of Dialysis Advocates, the
[[Page 20373]]
Association for the Advancement of Medical Instrumentation, the
American Society of Pediatric Nephrology, the American Dietetic
Association, DaVita, Inc., Dialysis Centers Inc., Fresenius Medical
Care North America, Gambro Healthcare, Kidney Care Partners, Life
Options Rehabilitation Advisory Council, the National Kidney
Foundation, the National Renal Administrator's Association, the
National Association of Nephrology Technicians, the Renal Care Group,
the Renal Physicians Association, the Renal Support Network, Medical
Education Institute, Inc., state survey agencies, ESRD Networks and the
Forum of ESRD Networks, healthcare professionals, administrators,
academics, dialysis patients, pharmaceutical and dialysis product
companies, and hospital-based and non-hospital-based dialysis
providers. Many commenters applauded the long overdue modernization of
the ESRD conditions for coverage, even though they may have disagreed
with a specific requirement or concept. Below we provide a brief
summary of each proposed provision, a summary of the public comments we
received, and our responses to the comments.
We received several comments on issues outside of the scope of this
final rule, which we will not address. Please note, that in this final
rule we have revised the title of subpart U from ``Conditions for
Coverage for Suppliers of End-Stage Renal Disease'' to read
``Requirements for End-Stage Renal Disease Facilities.'' We are
changing this final rule because the ``Hospital Conditions of
Participation: Requirements for Approval and Re-approval of Transplant
Centers to Perform Organ Transplants'', published on March 30, 2007 (72
FR 15198) updated and recodified the kidney transplant center
conditions for coverage and the remaining provisions only apply to the
ESRD Networks.
A. Part 414--Payment for Part B Medical and Other Health Services;
Payment for Home Dialysis Equipment, Supplies, and Support Services
(Proposed Sec. 414.330)
We proposed a new Sec. 414.330(a)(2)(iii)(C) that would require
the patient's home dialysis medical equipment supplier to report to the
facility, every 30 days, all services and items furnished to the
beneficiary, so that the information could be documented in the
patient's medical record.
Comment: Two commenters supported the proposed requirement for a
30-day reporting timeframe for durable medical equipment suppliers who
provide support services to home dialysis patients. Several other
commenters suggested that the 30-day timeframe was inappropriate and
restrictive and recommended we allow 45 days in the final rule.
Response: We agree with both sets of comments because we believe
that all information showing what supplies and services were provided
to the patient and when each was provided should be reported to the
ESRD facility on a regular basis. However, we agree with the second
group of commenters that the 30-day timeframe is restrictive.
Therefore, to allow greater flexibility, we have modified the final
rule at Sec. 414.330(a)(2)(iii)(C) to allow durable medical equipment
suppliers to report to the ESRD facility providing support services at
least once every 45 days.
B. Part 488--Survey, Certification, and Enforcement Procedures; Special
Procedures for Approving End-Stage Renal Disease Facilities (Proposed
Sec. 488.60)
We proposed to retain the procedures for approving ESRD facilities
as specified at Sec. 488.60. We received one public comment pertaining
to the procedures for approving ESRD facilities. The comment and
response are found at the end of this section. We have recodified Sec.
405.2180, Sec. 405.2181, Sec. 405.2182, and Sec. 405.2184 as Sec.
488.604, Sec. 488.606, Sec. 488.608, and Sec. 488.610, respectively.
These provisions were relocated without any modifications. Comments
pertaining to hemodialyzer reuse sanctions are addressed in the Sec.
494.50, ``Reuse of hemodilayzers and bloodlines'' discussion, later in
this preamble.
Comment: One commenter expressed concern regarding the
certification process for ESRD facilities. The commenter remarked that
facilities applying for initial approval may not have all of the data
required by the conditions for coverage in accordance with Sec.
488.60(a).
Response: Although we understand the commenter's concern that a new
provider may not have all of the required data available, data are
important for use in improving quality outcomes and play an important
part in the management and oversight of the ESRD facilities. Therefore,
we are retaining the provisions of Sec. 488.60(a) as proposed. In
addition, the absence of data would not necessarily result in the
denial of certification. If an ESRD facility is unable to supply all of
the data required in Sec. 488.60(a), the facility could be cited at a
standard deficiency level, thus emphasizing the importance of the data,
but not precluding the ESRD facility from receiving approval to operate
in the Medicare program.
C. Part 494--Conditions for Coverage for End-Stage Renal Disease
Facilities
1. Subpart A (General Provisions)
a. Basis and Scope (Proposed Sec. 494.1)
We proposed a new organizational format for the conditions for
coverage, which permitted the elimination of almost all of Sec.
405.2100, Scope of subpart. This section consists largely of a
description of the contents of the existing ESRD conditions for
coverage. We proposed at Sec. 494.1 to identify the statutory
authority for the revised regulations, and to state that provisions of
part 494 would serve as the basis for survey activities for determining
whether a dialysis facility met the conditions for coverage under the
Medicare program. We received no comments on this section.
b. Definitions (Proposed Sec. 494.10)
We proposed to recodify Sec. 405.2102 as Sec. 494.10, with an
abbreviated set of definitions. While Sec. 405.2102 defined 32 terms,
we proposed to define only 7 terms at Sec. 494.10. We proposed to
eliminate several terms that were self-evident and others that would
not be utilized in these revised conditions. In addition, we did not
believe it would be appropriate to have substantive requirements
contained within definitions, so we proposed to move definitions that
contained qualification requirements, such as the term
``interdisciplinary team,'' to the appropriate conditions in the final
rule.
Comment: A few commenters suggested revisions to the proposed
definition for ``dialysis facility.'' One commenter recommended we
adopt the phrase ``chronic kidney dialysis facility'' and two other
commenters suggested the addition of ``self-care dialysis'' to the
current list of services provided by the facility.
Response: Adding the word ``chronic,'' we believe, would add no
value to the term ``dialysis facility'' since kidney disease requiring
outpatient dialysis is chronic by nature. The proposed definition for
``dialysis facility'' does recognize self-care dialysis. Self-care
dialysis is a modality described in section 1881 of the Act. We believe
the proposed definition of ``dialysis facility'' is sufficient.
Therefore, we adopt this definition as proposed.
Comment: Two commenters suggested adding language to clarify that a
facility that taught a patient how to self-cannulate would not need to
obtain
[[Page 20374]]
certification as a self-dialysis unit exclusively because of such
instruction.
Response: We agree with the commenters that any dialysis facility
that is Medicare-certified to provide outpatient dialysis services may
include instruction in self-cannulation in its dialysis program. We do
not require any additional certifications, nor is a separate ``self-
dialysis'' certification category available. Dialysis facilities
receive Medicare certification to provide in-center dialysis or home
dialysis training and support services, or both. We are not adding a
regulatory statement regarding the absence of a self-dialysis
certification category to this final rule.
Comment: One commenter requested additional clarification regarding
what would constitute ``discharge'' (for example, ``30 days after
departure from a facility for any reason'').
Response: Our intent was to describe the cessation or end of
patient care services for patients who either voluntarily leave the
facility or for patients who are discharged for reasons listed at Sec.
494.180(f). To address the commenter's concern, we have added
clarifying language at Sec. 494.10 to read, ``Discharge means the
termination of patient care services by a dialysis facility or the
patient voluntarily terminating dialysis when he or she no longer wants
to be dialyzed by that facility.''
Comment: We requested comments regarding whether to reference
nursing facilities (NFs) and skilled nursing facilities (SNFs) in the
definition for ``home dialysis.'' We received many comments regarding
the definition of ``home dialysis.'' Some commenters questioned the
definition of ``home,'' while others commented that nursing homes and
other institutional settings were appropriate for home dialysis. Yet
others stated that nursing homes and other institutional settings were
inappropriate for home dialysis. One commenter expressed concern
regarding permanent versus temporary residence status within a nursing
facility. One commenter suggested we adopt a new term, ``institutional
home dialysis,'' to describe patients in a nursing home setting. Other
commenters suggested a separate definition for dialysis provided in a
nursing home setting that would be distinct from ``home dialysis.''
Many commenters noted the nursing home setting is different from
the typical dialysis facility setting, and that the needs of the NF/SNF
patient population are unique. One commenter proposed the term ``staff
assisted nursing home dialysis'' be used. Other topics of concern
included training course specifications, recommendations about
peritoneal dialysis and hemodialysis modalities, and the burden
associated with including NFs and SNFs in the definition.
Some commenters believed that neither short nor long-term stays in
NFs/SNFs should be considered a patient's home for purposes of home
dialysis, while others took the opposite view. Other commenters
responded that only a long-term stay in a NF/SNF should be considered a
patient's home for purposes of home dialysis. Major dialysis
associations and a major nursing home association urged Centers for
Medicare and Medicaid Services (CMS) not to classify NF/SNF as the
patient's ``home'' in this final rule, but to convene an expert panel
to study this complex issue and then address it in a separate rule at a
later date.
Response: We understand the concerns of commenters. Currently a SNF
may be considered a patient's home for self-dialysis, as noted in the
Medicare Claims Processing Manual, which can be found at http://
www.cms.hhs.gov/manuals/downloads/clm104c20.pdf and as noted in the
Program Integrity Manual, Chapter 5 at http://www.cms.hhs.gov/manuals/
downloads/pim83c05.pdf.
We recognize that the provision of hemodialysis to nursing home
patients presents unique challenges, given this frail population. We
note that there was no consensus within either the renal community or
the medical community at large as to the inclusion of SNFs or NFs in
the definition of ``home dialysis.'' A more detailed discussion of this
issue can be found later in this preamble under the ``Care at home''
condition (Sec. 494.100). Given the variety of differing comments, we
believe that a regulation regarding NF/SNF dialysis would be premature.
Therefore, we will consider addressing this issue at a later date, and
the current guidance for dialysis in a nursing home environment will
remain in effect at this time.
Comment: Three commenters suggested that the definition for
``interdisciplinary team'' use the same language as that of Sec.
494.80, and that the definitions be cross-referenced throughout the
text.
Response: The composition of the interdisciplinary team is a
minimum requirement of this final rule. We are not including
requirements in the definition section. We are defining the
``interdisciplinary team'' in the ``Patient assessment'' condition
opening paragraph at Sec. 494.80. We have also added the requirement
to the ``Patient plan of care'' condition at Sec. 494.90, to include
the same language describing the composition of the team. The
definition for ``interdisciplinary team'' appearing under Sec. 494.10
in the proposed rule has been removed from this final rule.
Comment: We received several comments regarding the definition of
``self-dialysis.'' Two commenters suggested changing the definition
from ``dialysis performed with little or no professional assistance''
to ``dialysis performed with limited or no professional assistance * *
*.'' Some commenters stated the definition should not reference the
training requirement at Sec. 494.100(a) since such requirement would
not apply to all self-dialysis, and that many patients would perform
some level of self-care in the facility. One commenter recommended that
we issue interpretive guidelines to address the issue of patients that
would perform self-care dialysis in a facility. Another commenter
suggested dropping ``self-dialysis'' terminology from the definition
section of this final rule.
Response: ``Self-dialysis'' is addressed in section 1881 of the Act
and the Secretary has the discretion to define ``self-dialysis
services'' in regulations. We are retaining the proposed language,
which contains the term ``little'' because we believe ``limited'' may
imply the necessity of a potentially higher degree of professional
assistance for self-dialysis patients than envisioned by the statute.
Interpretive guidelines will be developed to instruct the surveyors how
to review facilities for compliance with the requirement.
Comment: Several commenters requested clarifications of terminology
and additional definitions in the final rule such as: New patient;
first dialysis; direct supervision; and grievance.
Response: The terms ``first dialysis'' and ``new patient'' are
clarified in the section in which the terms are used. For example,
``new patient'' is now clarified in the ``Patient assessment''
condition at Sec. 494.80(b). The term ``direct supervision'' has been
deleted from the final rule, as explained in the preamble discussion
for ``Personnel qualifications'' at Sec. 494.140(e)(3). ``Grievance''
is discussed in the preamble for ``Patients' rights'' at Sec. 494.70.
Comment: A renal association recommended that we define the term
``standards'' in the final rule since we used that term in the preamble
of the proposed rule. The commenter noted that the use of the term
``standards'' is significant and should be explicitly defined to ensure
consistency throughout the regulation. The commenter also noted that
each of the NKF's clinical practice guidelines
[[Page 20375]]
contains a disclaimer stating that guideline is ``not intended to
define a standard of care, and should not be construed as one.''
Response: The term ``standards'' appears throughout the regulation,
as it is used to identify levels of requirements within each condition
for coverage. Historically, our conditions of participation and
conditions for coverage are written in hierarchical form of conditions,
with standards and elements (or factors) contained within the
conditions. For the most part they are written as individual,
surveyable requirements. Merriam-Webster's Collegiate Dictionary
defines ``standards'' as ``something established by authority, custom,
or general consent as a model or example.'' This definition matches how
the term ``standards'' is used in this final rule. When using the term
``standards'' as applied to care of patients, we expect that
professionals would rely upon principles and practices of care that
are, for example, widely used and supported by professional
organizations, academic institutions, and recognized standard-setting
organizations. We recognize that professionals may vary in their use of
particular ``standards.'' We assume the commenter is concerned about
the use of the terms ``standards'' as used in the preamble discussion
of facility-wide standards to be used for enforcement. Any facility-
level standards for Medicare participation developed subsequent to
publication of this final rule, will be developed in accordance with
the National Technology Transfer and Advancement Act of 1995 (NTTAA)
process adopted by the Secretary, as discussed in the ``Governance''
condition at Sec. 494.180.
c. Compliance With Federal, State, and Local Laws and Regulations
(Proposed Sec. 494.20)
We proposed a slightly broader version of Sec. 405.2135 in our
February 2005 proposed rule. While Sec. 405.2135 specifies applicable
laws and regulations pertaining to licensure, fire safety, equipment,
and other relevant health and safety requirements with which a facility
had to comply, we proposed that, additionally, facilities specifically
comply with State and local building codes, and any laws regulating
drugs and medical device usage.
Comment: Several commenters suggested deleting the reference to
``drugs'' at proposed Sec. 494.20. Commenters are concerned that this
reference to drugs would restrict physicians' use of Medicare Part B
covered drugs for ``off label'' use.
Response: We agree with the commenters. The reference to ``drugs''
has been removed from Sec. 494.20 of the regulation text. Medicare
contractors may make reasonable and necessary determinations regarding
off-label uses of drugs pursuant to instructions published in program
manuals.
Additionally, we removed the phrase ``staff licensure and other
personnel staff qualifications'' from Sec. 494.20, as this requirement
may be found in ``Personnel qualifications'' at Sec. 494.140. We
removed the phrase ``fire safety, equipment, building codes'' from
Sec. 494.20, as these issues are addressed in the ``Physical
environment'' condition at Sec. 494.60. In addition, we removed the
phrase ``medical device usage'' from Sec. 494.20, as it is covered
under the condition for ``Water and dialysate quality'' at Sec.
494.40, the condition for ``Reuse of hemodialyzers and bloodlines'' at
Sec. 494.50, the ``Physical environment'' condition at Sec.
494.60(b), and in the ``Care at home'' condition at Sec. 494.100.
Comment: A commenter stated that water treatment systems are
``medical devices'' and fall under Food and Drug Administration (FDA)
regulations. The commenter stated that the proposed rule preamble
suggests that water systems would have to meet FDA guidance document
requirements even if installed before May 1997. The commenter is
concerned that replacement of water systems with ``510(k) cleared''
systems would incur needless expense.
Response: As explained above, we have removed the words
``equipment'' and ``medical device usage'' from Sec. 494.20 and do not
single out these categories of law. Facilities are expected to comply
with all Federal, State and local laws regarding health and safety.
Under current FDA regulations, all water treatment systems installed
after May 30, 1997 must meet review requirements under section 510(k)
of the Food, Drug, and Cosmetic Act (21 U.S.C. sec. 360(k)) as
described in Guidance for the Content of Premarket Notifications for
Water Purification Components and Systems for Hemodialysis (http://
www.fda.gov/cdrh/ode/hemodial.pdf). This document is intended to
provide guidance in the preparation of a regulatory submission and
reflects the current FDA review guidance for water purification
components and systems for hemodialysis. Water purification systems
installed before May 30, 1997 are not affected by this guidance;
however, all systems installed after this date must meet FDA
requirements. Regardless of when a water purification system was
installed, the system must yield water and dialysate that meets AAMI
standards and must be monitored and maintained in accordance with the
AAMI RD52 guidelines, which are incorporated by reference in this final
rule at Sec. 494.40.
Comment: A number of commenters recommended we include a reference
to the Americans with Disabilities Act of 1990 (Disabilities Act)
within this condition. The rationale is that patients must be
accommodated for mobility, hearing, vision, or other disabilities or
language barriers.
Response: A specific reference to the Disabilities Act is not
necessary since ESRD facilities must comply with all applicable
Federal, State, and local laws, including the Disabilities Act. The
Department of Justice, Civil Rights Division, is charged with oversight
and enforcement of the Disabilities Act. We would also continue to
support the enforcement of the Disabilities Act provisions through the
survey process under Sec. 494.20.
2. Subpart B--Patient Safety
a. Infection Control (Proposed Sec. 494.30)
We proposed a separate condition for coverage for infection control
requirements, to update the provisions currently found at Sec.
405.2140(b) and Sec. 405.2140(c). We proposed incorporating by
reference ``Recommended Infection Control Practices for Hemodialysis
Units at A Glance'' precautions found in the CDC publication
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients'' (DHHS/CDC, pages 20-21), with the
exception of the screening recommendations for hepatitis C. We proposed
that dialysis facilities implement appropriate procedures for patient
isolation; for the handling, storage, and disposal of waste; and the
disinfection of surfaces, devices, and equipment. We proposed the
appointment of an infection control officer registered nurse (RN) to
ensure oversight of the facility's infection control program,
maintenance of current infection control information, reporting of
infection control issues to the facility chief executive officer (CEO)
or administrator and the facility improvement committee, and the
development of facility infection control improvement recommendations.
We also proposed monitoring and reporting standards that would require
the facility to analyze and document the incidence of infection to
identify trends, establish baselines, take action to reduce future
infection control incidents, and report incidences of communicable
diseases as
[[Page 20376]]
required by Federal, State, and local regulations.
Comment: We received numerous comments on Sec. 494.30 ``Infection
control'' condition. Many commenters agreed with the inclusion of the
CDC infection control precautions for hemodialysis settings. Some
commenters recommended that we incorporate in the final rule the entire
CDC (RR05) document entitled, ``Recommendations for Preventing
Transmission of Infections Among Chronic Hemodialysis Patients''
(published on April 27, 2001), rather than only the ``At A Glance''
section.
A number of commenters referenced particular infection control
precautions included in the ``At A Glance'' section and requested
clarification or raised issues related to the cost or logistics of
implementing the specific precaution in a hemodialysis facility. The
precautions referred to in these comments include: use of disposable
items, use of cloth-covered blood pressure cuffs, use of leak-proof
containers for used hemodialyzers, specifications for medication carts,
carrying supplies or medications in the pockets of staff, and isolation
room requirements. Some commenters stated that there was no need for
every new dialysis unit to have an isolation room. Two commenters
supported having separate staff to care for hepatitis B-positive
patients, but other commenters stated the cost of separate staff for
this would be prohibitive.
Response: We appreciate the support for inclusion of the CDC
hemodialysis infection control precautions in this final rule. Based on
the comments, it is apparent that clarifications are needed for the
``At A Glance'' guidelines, which are an abbreviated version of the CDC
RR05 ``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients.'' The majority of comments concerning
specific precautions are addressed in the CDC narrative section
entitled ``Recommendations'' on pages 18 through 28 of
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients.'' In order to better clarify the
requirements of the infection control precautions, we are expanding our
RR05 incorporation by reference to include the entire
``Recommendations'' narrative section of the document (pages 18-28) in
the final rule, with one exception (hepatitis C screening), as
discussed below. The introduction and background sections of the RR05
document (pages 1-17) provide the evidentiary basis for the recommended
precautions. The entire CDC RR05 document provides rich background
information and rationale for the recommended practices; we encourage
facilities to use the entire document as a resource.
The RR05 CDC infection control precautions state that items taken
into the dialysis station should be disposed of, dedicated for use only
on a single patient, or cleaned and disinfected before being taken to a
common clean area or used on another patient. Items that cannot be
cleaned and disinfected (for example, adhesive tape, cloth-covered
blood pressure cuffs) should be dedicated for use only on a single
patient. Blood pressure cuff covers may be more cost-effective and may
be used for blood pressure cuffs that cannot be decontaminated easily
between patients. In contrast, rolls of tape cannot be decontaminated
and can serve as a source of contamination for both facility personnel
and patients. Tape rolls must be dedicated to a single patient, or
disposed of after patient use.
Hemodialyzers carried to the reuse area should always be in a leak-
proof container. We wish to prevent a blood-contaminated item from
potentially contaminating the treatment (and clean) areas as it is
carried from a patient's station. A container could be a plastic bag.
We believe that the practice of carrying a contaminated hemodialyzer to
the reuse room without the use of a leakproof container does not
adequately prevent contamination.
Although one commenter stated that banning a medication cart and
taping medication to the hemodialysis machine would ``waste'' RN time,
the CDC has made clear that patient safety is best protected and risk
of cross-contamination reduced when medications are prepared and
distributed from a centralized clean area dedicated to that purpose.
Another commenter argued that staff should have immediate access to
gloves for times when a patient suddenly starts to bleed, and that
staff members should be allowed to carry extra gloves in their pockets.
The CDC precautions do not allow this practice. Instead, the facility
should have gloves strategically placed so that staff has adequate
access to them for both routine and emergency use.
Regarding the treatment of hepatitis B-positive patients, many
commenters provided alternative isolation room recommendations and
requested clarification of the isolation room requirement for new units
as well as for existing units. The ``At A Glance'' page states (under
``Management of HBsAg-Positive Patients'') that the dialysis facility
should dialyze hepatitis B surface antigen (HBsAg) positive patients in
a separate room using separate machines, equipment, instruments, and
supplies; and that staff members caring for HBsAg-positive patients
should not care for hepatitis B virus (HBV) susceptible patients at the
same time (for example, during the same shift or during patient change-
over). CDC language from page 27 of the CDC RR05 document states, ``For
existing units in which a separate room is not possible, HBsAg-positive
patients should be separated from HBV-susceptible patients in an area
removed from the mainstream of activity and should undergo dialysis on
dedicated machines. If a machine that has been used on an HBsAg-
positive patient is needed for an HBV-susceptible patient, internal
pathways of the machine can be disinfected using conventional protocols
and external surfaces cleaned using soap and water or a detergent
germicide.'' Therefore, we are incorporating this section by reference
into the ``Infection control'' condition at Sec. 494.30, as it is
found in the ``Recommendations'' narrative section of the CDC ``At A
Glance'' infection control precautions. However, we are allowing
dialysis facilities extra time to come into compliance with the
provision requiring a separate isolation room (recommendation found on
pages 27 and 28 under the ``HBV-Infected Patient'' section header of
RR05), since in some cases the provision would require that a facility
retrofit its building, which would necessitate project development,
architectural design, contractor bids, building permits, and time to
complete the job. Therefore, we are allowing dialysis facilities 300
days after the publication of this final rule in the Federal Register
to comply with the requirements of this provision. In addition, any
HBsAg-positive patient in an existing dialysis facility should be
separated from hepatitis B-susceptible patients either by a buffer zone
of hepatitis B-immune patients or by a demarcated physical space at
least equal to the width of one dialysis station. Separate dedicated
supplies and equipment must be used to provide care to the HBsAg-
positive patient. Note that ``separate equipment'' includes
glucometers. Use of an ``end of row'' hemodialysis station can
facilitate the separation of the area from the mainstream of the
dialysis facility's activities and decreases the number of adjacent
dialysis stations. If this space is needed for both HBsAg-positive as
well as HBsAg-negative patients on other shifts, the space may be
disinfected using conventional protocols and used for both types of
patients at different
[[Page 20377]]
times. If a facility does not have any HBsAg-positive patients, this
space may be used by non-HBsAg-positive patients on a normal basis.
Every facility must have the capacity to separate HBsAg-positive
patients in the facility.
In response to comments that not every new unit should be required
to have an isolation room due to the low incidence of hepatitis B in
hemodialysis patients, we have added a waiver provision at Sec.
494.30(a)(1)(ii) that states, ``When dialysis isolation rooms as
required by (a)(1)(i) are available locally that sufficiently serve the
needs of patients in the geographic area, a new dialysis facility may
request a waiver of such requirement. Such waivers are at the
discretion of and subject to such additional qualifications as may be
deemed necessary by the Secretary.''
The CDC infection control precautions specifically call for
separate staff to care for hepatitis B-positive patients to prevent
infection of susceptible dialysis patients. According to the CDC, using
separate staff is a very effective method to reduce the spread of HBV.
One staff person may care for a HBsAg-positive patient and immune
patients at the same time, but may not simultaneously care for
hepatitis B-susceptible patients. Section 494.30 requires dialysis
facilities to implement this infection control precaution.
Comment: Two commenters pointed out that the RR05 ``At A Glance''
section uses the word ``should'' and seems to allow less than full
compliance with the infection control precautions.
Response: We recognize that the RR05 CDC document uses the word
``should'' when describing implementation of the infection control
precautions, for example, ``clean areas should be clearly designated
for the preparation, handling and storage of medications * * *'' The
CDC document is written as guidelines and therefore guideline language
is used. For purposes of these Conditions for Coverage, the CDC
infection control precautions, which are incorporated by reference, are
mandatory and must be adhered to and demonstrated within the dialysis
facility. The regulation states, ``the facility must demonstrate that
it follows standard infection control precautions' by implementing the
CDC hemodialysis infection control practices found in the RR05
document. The guidelines incorporated by reference will be deemed
mandatory in the survey process.
Comment: One commenter asked whether a reverse isolation negative
pressure room would be required.
Response: The RR05 CDC recommended infection control practices
incorporated by reference address the unique needs of a hemodialysis
unit and include contact precautions. When airborne pathogens are
discovered within the dialysis unit, the CDC infection control
recommendations regarding airborne pathogens should be consulted and
the proper measures taken to protect patients and staff from exposure.
This could mean that the affected patient is transferred to a setting
that provides the necessary isolation precautions for the pathogen. The
facility may want to have an agreement with a hospital if the facility
discerns that this is necessary; however, we are not incorporating this
provision into the Medicare ESRD conditions for coverage.
Comment: One commenter asked whether staff cover gowns are
required.
Response: Staff scrubs or uniforms are sufficient attire within the
dialysis unit, except for times when one might expect to be exposed to
a blood spattering. Cover gowns primarily serve to protect a staff
member from exposure to blood within the dialysis unit. This is
addressed on page 22 of RR05 CDC document.
Comment: We received more than a dozen comments regarding the CDC
RR05 recommendation for hepatitis C screening of dialysis patients.
Most of the comments supported the CDC recommendation and several
suggested that Medicare pay for hepatitis C screenings. Commenters
stated that hepatitis C is an important pathogen for dialysis patients,
screening would allow for early detection, and would alert the facility
to significant breaks in use of infection control precautions. Some
commenters did not support hepatitis C screening by the dialysis
facility, and one noted that a positive diagnosis would not change
treatment or patient care within the dialysis facility.
Response: In the proposed rule, we specified an exemption for
hepatitis C screening, since Medicare only covers diagnostic hepatitis
C testing when indicated, and does not cover general screening for
hepatitis C. A patient with a hepatitis C positive test is treated in
the dialysis facility with the same protocols as a patient who is not
positive for hepatitis C. However, transmission of hepatitis C serves
as a marker to evaluate the adequacy of infection control practices
within a dialysis facility. Medicare generally covers preventive care
and screenings if stipulated in law, including diagnostic testing. We
will continue to omit from our incorporation by reference the CDC RR05
sections that specify hepatitis C screening.
On December 14, 2005, we published a coverage decision memo (CAG-
00304N) that allows Medicare coverage of hepatitis panel testing when
there is an elevation of liver enzyme levels. The memo title is
``Decision Memo for Addition of ICD-9-CM code 790.4, Nonspecific
Elevation of Levels of Transaminase or Lactic Acid Dehydrogenase, as a
Covered Indication for the Hepatitis Panel/Acute Hepatitis Panel
National Coverage Determination'' and may be found at http://
www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=173. Elevated liver
enzymes, with or without other signs or symptoms of hepatitis, is a
covered indication for the hepatitis panel. Most hemodialysis patients
with newly acquired Hepatitis C virus (HCV) infection have elevated
serum transaminase levels. Elevations in serum transaminase levels
often precede anti-HCV seroconversion. Monthly serum ALT (a
transaminase) determination is included in the composite payment to
renal dialysis facilities. Consequently, if a beneficiary has an
elevated ALT, the provider may order a diagnostic hepatitis panel,
which includes a hepatitis C antibody test as part of the panel. The
hepatitis panel National Coverage Determination (NCD) does not require
the physician to order all of its constituent component tests. Thus, a
provider may order a hepatitis C antibody test when the beneficiary's
serum ALT, ordered and covered for monthly testing in the composite
rate, is elevated.
Comment: A few commenters referred to the CDC guidelines regarding
injectable medications and disagreed with the established protocol that
allows re-entry of single-use medication vials.
Response: The April 27, 2001/50 (RR05); 1-43 CDC infection control
guidelines, ``Recommendations for Preventing Transmission of Infections
Among Chronic Hemodialysis Patients'' (http://www.cdc.gov/mmwr/preview/
mmwrhtml/rr5005a1.htm) state: ``Intravenous medication vials labeled
for single use, including erythropoietin, should not be punctured more
than once (196,197). Once a needle has entered a vial labeled for
single use, the sterility of the product can no longer be guaranteed.
Residual medication from two or more vials should not be pooled into a
single vial.''
We have retained the intent of this policy and the proposed
requirement at Sec. 494.30(b)(2), regarding current infection control
information including the most current CDC guidelines for the proper
techniques in the use of vials and ampules containing medication.
However, we have modified the wording slightly because we have
[[Page 20378]]
removed the proposed infection control officer requirement, as
discussed below.
Under the ``Oversight'' standard at Sec. 494.30(b)(2) we are
requiring the clinical staff to ``demonstrate compliance with current
aseptic technique when dispensing and administering intravenous
medications from vials and ampules.''
Comment: Several comments were submitted in response to our
solicitation as to whether we should incorporate by reference the
Healthcare Infection Control Practices Advisory Committee's (HICPAC)
``Hand Hygiene in Healthcare Settings'' guidelines and the ``Guideline
for Preventing Intravascular Device-Related Infections.'' Comments were
evenly divided regarding incorporation of the hand hygiene guidelines.
Two of the commenters stated there is no consensus between HICPAC hand
hygiene guidelines and guidelines developed by Society for Healthcare
Epidemiology of America (SHEA) regarding standards of care for
preventing nosocomial transmission of staph aureus and enterococcus.
While one commenter did not support incorporation of the intravascular
device guidelines, there was some support for their inclusion, notably
from the American Nephrology Nurses Association.
Response: We would expect that dialysis facilities demonstrate
adherence to professional standards of practice for infection control,
which include adherence to hand hygiene guidelines. This expectation is
included in the stem statement of the infection control condition:
``The dialysis facility must provide and monitor a sanitary environment
to minimize the transmission of infectious agents within and between
the unit and any adjacent hospital or other public areas.'' The
expectation of acceptable hand hygiene extends to all healthcare
providers. We will not specifically incorporate by reference the HICPAC
hand hygiene standards, but we do expect compliance to the hand hygiene
professional standards of practice.
We do not agree that the guidelines developed by SHEA regarding
standards of care for preventing nosocomial transmission of staph
aureus and enterococcus conflict with the HICPAC hand hygiene
standards. We note that the SHEA guidelines are not specific to
dialysis facilities where contact precautions are recommended, but
address infection control issues in the hospital setting. The SHEA
guidelines reflect the general lack of adherence by health care workers
to hand hygiene standards and recommend additional measures, such as
surveillance cultures, to prevent and monitor cross-contamination.
Facilities have the flexibility to use appropriate resources to assist
in the development and implementation of their hand hygiene infection
control and prevention program.
Catheter infections continue to be a concern in hemodialysis
facilities and lead to hospitalizations. HICPAC states in its
``Guidelines for the Prevention of Intravascular Catheter-Related
Infections'' RR-10 document (http://www.cdc.gov/mmwr/preview/mmwrhtml/
rr5110a1.htm) (page 11), that the use of catheters for hemodialysis is
the most common factor contributing to bacteremia in dialysis patients
and the relative risk for bacteremia in patients with dialysis
catheters is sevenfold the risk for patients with primary arteriovenous
fistulas. In Sec. 494.30(a)(2) we are incorporating by reference the
pertinent hemodialysis catheter use sections (pages 13-14, and 17-18)
of RR-10, 2002, ``Guidelines for the Prevention of Intravascular
Catheter-Related Infections.'' These guidelines describe appropriate
health-care worker education and training, surveillance, hand hygiene
(I-III, page 16), aseptic technique (IV, page 16), hemodialysis
catheter exit site care (section III-V, page 21), and catheter-site
dressing regimens (section VI, C, page 22), and are the nursing
standard of practice for catheter care. We expect that incorporation of
these guidelines will increase staff awareness of the protections
needed for hemodialysis patients with catheters and lead to reduced
catheter infections.
Comment: Few commenters responded to our solicitation for comment
regarding whether we should incorporate by reference the American
Institute of Architects (AIA) Guidelines for Design and Construction of
Hospitals and Health Care Facilities, which outline building
requirements pertinent to dialysis facilities. Comments were split
between supporting and rejecting AIA guidelines, and incorporation by
reference if adopting the guidelines.
Response: We have not incorporated the AIA building standards in
our final rule. However, facilities must comply with all State and
local building codes/requirements.
Comment: Several commenters addressed our proposed infection
control officer requirement at Sec. 494.30(b)(2). Some supported
having an RN assume the role of the infection control officer. Others
believed that a staff member other than an RN should assume the role.
Some commenters stated this role was not the best use of RN time, and a
few cited cost concerns. Several commenters stated that oversight of
infection control should be performed by the medical director or that
the medical director should be notified of infection control issues at
proposed Sec. 494.30(b)(2)(ii) instead of our proposed notification of
the chief executive officer or administrator and the quality
improvement committee.
Response: We understand that dialysis facilities may face a
shortage of RNs and that in many facilities RNs must be used to perform
duties that only an RN can perform. While comments supported infection
control to protect patient safety, several alternatives to an RN
infection control officer were suggested. In response to comments and
in order to increase facility flexibility in assigning staff roles, we
have removed the infection control officer requirement from Sec.
494.30(b)(2), and added infection control to the quality assessment and
performance improvement (QAPI) condition at Sec. 494.110(a)(2)(ix) as
a required topic. This change requires that infection control be
addressed within the action-oriented, data-driven QAPI program, which
is under the direction of the medical director and requires RN and
interdisciplinary team participation.
In response to comments we have also modified the proposed
requirement at Sec. 494.30(b)(2)(ii) (now Sec. 494.30(b)(3)), to
require that clinical staff report infection control issues to the
dialysis facility's medical director and the quality improvement
committee instead of the chief executive officer or administrator. The
medical director has a critical role in addressing infection control
issues in the dialysis facility and Sec. 494.150(c)(2)(i) now requires
the medical director to ensure that staff adhere to infection control
policies and procedures.
Comment: We received a few comments regarding the role of the
patient and patient perceptions of infection control practices in
dialysis facilities. One patient stated that patients should be fully
informed about infection control so they can protect themselves and be
aware of staff infection control violations. Another patient's
observation was that facility staff has no training regarding infection
control and no one seems to worry about its ramifications.
Response: We agree that the dialysis patient has a role in
assisting the staff in preventing the spread of infection. It is
appropriate for the patient to be educated regarding infection control.
We have added ``infection prevention and personal care'' to the Patient
Education standard under Sec. 494.90(d) in
[[Page 20379]]
the ``Patient plan of care'' condition. The facility should provide
information to dialysis patients on topics including current infection
control precautions, the facility's infection control practices, and
the role of the patient in preventing the spread of infection. As
explained above, we have strengthened infection control by making it a
condition for coverage and expect that dialysis staff will comply with
the hemodialysis infection control precautions developed by the CDC and
required by this rule.
Comment: One commenter asked whether State surveyors could enforce
local regulations and laws pertaining to disposal of hazardous wastes.
Response: Surveyors make referrals regarding unlawful disposal of
hazardous wastes to the appropriate local authorities. If there is a
problem, it can be cited by the surveyor under Sec. 494.20,
``Compliance with Federal, State, and local laws and regulations,''
when local authorities confirm infringement.
Comment: It was suggested that the final rule require more
surveillance, include septicemia and infection data elements, include
an added CPM or standard for infection control, and require mandatory
reporting of such data on the DFC Web site.
Response: As stated above, the facility must address infection
control within the action-oriented, data-driven QAPI program.
Surveillance and use of infection data will be necessary components of
QAPI. We will consider the ``reporting'' as appropriate when developing
new CPMs and adding new measures to the DFC Web site. We are not
requiring new performance measures that have not been fully developed
in this regulation.
b. Water and Dialysate Quality (Proposed Sec. 494.40)
We proposed a separate condition for coverage to update the water
purity requirements that were incorporated by reference into part 405,
subpart U (Sec. 405.2140(a)(5)) in 1995. AAMI has since rescinded the
document from which the sections were incorporated (ANSI/AAMI RD5:1992,
Hemodialysis Systems, second edition) and published updated AAMI
guidelines in 2001. We proposed to incorporate sections from the new
AAMI document, ``Water Treatment Equipment for Hemodialysis
Applications'' (ANSI/AAMI RD62:2001), to update the bacterial and
chemical concentrations allowed in water used in hemodialysis. The new
AAMI guidelines established action levels for contaminants in addition
to merely identifying unsafe contaminant levels. At ``action levels,''
the facility must implement corrective actions to prevent contaminants
from reaching unsafe levels. We also proposed water treatment equipment
requirements and water testing frequency and sample sites that are
consistent with the new AAMI document, ``Dialysate for Hemodialysis''
(ANSI/AAMI RD52:2004). We proposed chlorine and chloramine testing
frequency, thresholds, and actions for unacceptable high levels to
prevent the occurrence of hemolytic anemia in patients. We proposed
corrective action plan and adverse event standards to further protect
patient safety. We additionally proposed that facilities use
bicarbonate dialysate, which has the potential for high levels of
bacterial contamination, within the timeframe specified by the
manufacturer.
Comment: We received many comments regarding Sec. 494.40 ``Water
quality'' condition. The comments were unanimous in supporting
incorporation of AAMI water quality guidelines. Several of the comments
recommended that the more recent 2004 ANSI/AAMI RD52 ``Dialysate for
hemodialysis'' guidelines, written for water treatment system users, be
incorporated by reference, rather than the 2001 ANSI/AAMI RD62 ``Water
treatment equipment for hemodialysis applications,'' which are
addressed primarily to the manufacturers of equipment. A commenter
associated with the AAMI Renal Disease and Detoxification Committee
stated that the 2001 ANSI/AAMI RD62 guidelines are slated to be revised
in the near future.
Response: We agree with the commenters that ANSI/AAMI RD52:2004
``Dialysate for hemodialysis'' is the more appropriate set of
guidelines to incorporate by reference into these conditions for
coverage. In fact, the RD52 guidelines addressing water purity
monitoring and equipment parameters are similar to the requirements we
proposed at Sec. 494.40(a), Sec. 494.40(b), and parts of Sec.
494.40(c). Therefore, we are incorporating the AAMI guidelines (ANSI/
AAMI RD 52:2004) by reference at Sec. 494.40(a). These RD52 guidelines
are compatible with the RD62 guidelines that we proposed to incorporate
by reference, and are the standard of practice in dialysis facilities.
We have removed the redundant sections of proposed Sec. 494.40(a)
through Sec. 494.40(c) from the regulation, since the ANSI/AAMI
RD52:2004 incorporation by reference addresses this issue. We are also
renaming this condition ``Water and dialysate quality'' to more closely
reflect the requirements of this condition.
Comment: One commenter recommended that we define ``established
pattern'' (as related to collecting cultures for new water systems)
(proposed Sec. 494.40(a)(2)(i)(B)), as being on a weekly basis until
an established pattern can be demonstrated.
Response: We agree. This issue is addressed in ANSI/AAMI RD52
(section 6.1--page 19; table 4), which, as discussed above, we are
incorporating by reference. This section states that cultures should be
drawn ``weekly until a pattern of consistent compliance with limits can
be demonstrated.'' We have removed proposed Sec. 494.40(a)(2)(i)(B).
Comment: One commenter stated that Sec. 494.40(a)(2)(ii)(C) and
(D) are redundant since the ``seasonal variations in source water''
specified as a trigger for chemical analysis at (C) will cause the
reverse osmosis (RO) rejection rate to fall below 90 percent, the
trigger listed at (D). A second commenter stated that RO is monitored
by both rejection rate and dissolved solids or resistivity, and all of
these types of monitoring should be indicated as acceptable.
Response: RO monitoring is addressed by ANSI/AAMI RD52 section
5.2.7 (page 10) and section 6.1 (pages 18-19), which we are
incorporating by reference. As explained above, we have removed the
redundant language from Sec. 494.40(a)(2)(ii)(C) and Sec.
494.40(a)(2)(ii)(D). Facilities also must follow the manufacturers'
instructions for feed water treatment and monitoring. In the absence of
manufacturer's recommendations, the AAMI guidelines require facilities
to monitor product water conductivity, total dissolved solids or
resistivity, and calculated rejection at a frequency and using
thresholds provided by the manufacturer.
Comments: Many commenters made recommendations or requested
clarification regarding carbon tank requirements at proposed Sec.
494.40(c)(1). Many commenters supported a two carbon tank requirement,
and some opposed it. A few commenters agreed with the 10-minute empty
bed contact time, while one commenter said that the ``adequate'' empty
bed contact time standard was too subjective. One commenter recommended
that we clarify that the second carbon tank is in series with the
first, and that we require the first tank to be replaced if test
results are above the specified permissible levels. A few commenters
pointed out that high chloramine levels may be mitigated with the use
of ascorbic acid.
Response: Section 5.2.1 of the ``Dialysate for hemodialysis'' ANSI/
[[Page 20380]]
AAMI RD:52 guidelines specify, ``Whether a device is included in a
particular water purification system will be dictated by local
conditions.'' Since comments overwhelmingly supported two carbon tanks
in series due to patient safety concerns and the fact that carbon tanks
also remove organic contaminants from water, we will require at least
two carbon tanks or equivalent components at Sec. 494.40(b)(1) of our
final rule (proposed Sec. 494.40(c)(1)). Section 5.2.5 of ANSI/AAMI
RD52 clarifies that two carbon tanks must be placed in series and that
the carbon bed must be replaced in the first tank when depleted. We
have added the phrase ``in series'' to our carbon tank requirement at
Sec. 494.40(b)(1), as suggested by the commenter. This RD52 section
also clarifies that empty bed contact time must be at least 5 minutes
in each bed. The empty bed contact time is an indicator of how much
water contact with the particles in the carbon bed occurs so that there
is adequate binding and removal of impurities.
AAMI does refer to use of ascorbic acid to correct chloramine/
chlorine levels in RD62 (section A.4.3.9), though only in reference to
portable water treatment systems. In RD52 (section 5.2.5 and appendix
section A.5.2.5), AAMI also acknowledges the supplementation of carbon
adsorption with other methods of chloramine removal.
In response to comments regarding an alternate means of correcting
chloramine/chlorine breakthrough that would permit the continuation of
hemodialysis, we have added a provision to the final rule at Sec.
494.40(b)(2)(ii)(A) to allow immediate corrective action, and confirm
through testing that the corrective action has been effective. We will
not limit the means by which chloramines/chlorine levels are brought
back into compliance at Sec. 494.40(b)(2)(ii)(A). This regulation
allows for use of other proven methods to remove chloramines including
ascorbic acid and new technologies that may be developed. When using
alternate methods to remove chloramines/chlorine, the facility must
perform the required testing to ensure the successful removal of
harmful chloramine/chlorine. After measures have been taken to resolve
the immediate problem of chloramine/chlorine breakthrough, the facility
must implement actions to maintain long-term compliance with acceptable
chloramines/chlorine levels. We have added a provision at Sec.
494.40(b)(2)(ii)(D), which requires facility action to ensure ongoing
compliance. This provision reads, ``The facility must * * * Take
corrective action to ensure ongoing compliance with acceptable chlorine
and chloramine levels as described in paragraph (b)(2)(i) of this
section.''
Comment: Many comments addressed our proposed requirement for
chlorine/chloramine testing (proposed Sec. 494.40(c)(2)) before each
patient shift or every 4 hours, whichever was shorter. The majority of
comments favored chlorine/chloramine testing only before every shift
and not every 4 hours. One commenter recommended we change the 4 hours
to 6 hours and retain the requirement, while another suggested we
delete the phrase ``whichever is shorter.'' A few commenters agreed
with the testing frequency of every 4 hours.
Response: According to ANSI/AAMI RD52, section 6.2.5 (page 20),
testing should be done at the beginning of the day and again before
each shift, and if there are no set shifts, then every 4 hours. We
refer to this section, which has been incorporated by reference, at
Sec. 494.40(b)(2)(i), and we believe it provides sufficient
clarification. We have deleted the proposed requirement at Sec.
494.40(c)(2).
Comment: One commenter stated the regulation should include maximum
carbon tank limits on usage time, flow, volume, and that testing for
iodine should be required.
Response: The AAMI guidelines call for chlorine/chloramine testing
every shift to monitor carbon tank performance. We are not aware of any
evidence suggesting that these precautions are insufficient. We believe
the commenter is suggesting that a minimum iodine number for the carbon
should be required. Section 5.2.5 of the AAMI RD52 document states that
``When granular activated carbon is used as the medium, it shall have a
minimum iodine number of 900.''
Comment: A few commenters stated that chlorine/chloramine testing
requirements should also allow the testing for total chlorine with a
limit of 0.10 mg/L.
Response: This suggestion corresponds with ANSI/AAMI RD52 section
6.1; table 4 (page 8) which allows total chlorine levels of less than
0.1 mg/L. This section is now incorporated by reference. We have
modified proposed Sec. 494.40(c)(2)(i), now Sec. 494.40(b)(2)(i) to
allow total chlorine testing with acceptable levels of less than 0.1
mg/L as an alternative to testing free chlorine and chloramine levels.
Comment: One commenter stated that chlorine/chloramine requirements
at proposed Sec. 494.40(c)(2)(ii) do not account for facilities with a
holding tank, and we should allow water in the holding tank to be used
if testing shows this water contains total chlorine < 0.1 mg/L.
Response: Water in the holding tanks may be used during failure of
carbon tanks only if testing indicates the holding tank water meets
AAMI chlorine/chloramines standards of < 0.1 mg/L total chlorine OR <
0.50 mg/L free chlorine AND < 0.1 mg/L chloramines and no additional
water is allowed to enter the tank. Revised Sec. 494.40(b)(2)(ii)(B)
(proposed (c)(2)(ii)) allows use of purified water in the holding tank
when it meets the AAMI standards at Sec. 494.40(b)(2)(i).
Comment: One commenter recommended that endotoxin levels be
measured in addition to blood and dialysis cultures when there is an
adverse event (proposed at Sec. 494.40(e)(1)), since cultures may be
negative even with high endotoxin levels.
Response: We agree with the commenter that measurement of dialysate
endotoxin levels should be performed along with dialysate cultures when
a suspected adverse event occurs. We note that the AAMI guidelines call
for dialysate bacterial cultures to be accompanied by endotoxin level
testing. The AAMI guidelines state that endotoxin testing, if performed
in the dialysis facility, can give results in about 1 hour, eliminating
the long delay between sampling and obtaining a result (ANSI/AAMI
RD52:2004, section A.1.4). We have added endotoxin testing to the blood
and dialysate culture requirement at Sec. 494.40(d)(1) (proposed Sec.
494.40(e)(1).
Comment: Two commenters requested that we clarify the language of
proposed Sec. 494.40(e) ``Adverse events'' (now Sec. 494.40(d)),
regarding the active surveillance of patient reactions during and
following dialysis. One commenter suggested that the word ``following''
be defined to mean ``after post-dialysis assessment with subsequent
discharge by nurse or caregiver.''
Response: We appreciate the comment; however, we believe that the
suggested definition is too narrow, since not every adverse advent will
be limited to the time period the patient is physically in the dialysis
unit. ``Following dialysis'' runs from the moment when the treatment
session ends through the time the patient leaves the unit and beyond.
In addition, when the patient calls and/or when the patient returns for
the next dialysis session, if there are symptoms that are correlated
with a water purity adverse event, then cultures and endotoxin testing
must be performed.
[[Page 20381]]
Comment: Many comments reflected concern regarding the proposed
requirement at Sec. 494.40(f) that mixed bicarbonate concentrate be
used within the timeframe specified by the manufacturer of the
concentrate, and the accompanying preamble statement that fresh
bicarbonate must not be mixed with other batches of fresh bicarbonate.
Several commenters stated that mixing batches of bicarbonate
concentrate may be unavoidable due to mixing processes and the use of
holding tanks. Two commenters agreed with limiting use of bicarbonate
to the time limit given by the manufacturer, while others stated that
it was only necessary to use bicarbonate the same day it was mixed.
Some commenters stated that bicarbonate is the most vulnerable part of
dialysis solutions.
Response: AAMI addresses procedures for bicarbonate concentrate in
ANSI/AAMI RD52, section 7.1 (page 24), stating, ``Storage times for
bicarbonate concentrate should be minimized, as well as the mixing of
fresh bicarbonate concentrate with unused portions of concentrate from
a previous batch.'' Section 5.4.4.3 (page 15), also states, ``Once
mixed, bicarbonate concentrate should be used within the time period
recommended by the manufacturer of the concentrate. The concentrate
shall be shown to routinely produce dialysate meeting the
recommendations of 4.3.2.1.'' ANSI/AAMI RD52 stipulates the use of
bicarbonate concentrate within the time period recommended by the
manufacturer and does not expressly prohibit the mixing of bicarbonate
concentrate. If the first batch of bicarbonate concentrate has not yet
expired, it could be mixed with a second batch, provided the first
batch had not expired in accordance with the manufacturer's time
limitations before it was used. We have removed the proposed water and
dialysate quality standard at Sec. 494.40(f), regarding unused
bicarbonate, since we are instead incorporating ANSI/AAMI RD52 by
reference.
Comment: We received many comments regarding whether we should
include requirements related to ultrapure dialysate. Although two
commenters (including a large patient organization) supported ultrapure
dialysate requirements, a number of commenters opposed such
requirements, citing a lack of evidence that supported the use of
ultrapure dialysate. One commenter stated that in light of new findings
showing that ultrapure dialysis could be beneficial to hemodialysis
patients, ultrapure dialysate should be strongly encouraged. Another
commenter, who was a national expert in the area of dialysis water
treatment systems, suggested that we require that all new water systems
installed after publication of the final rule be capable of delivering
ultrapure dialysate. This would allow facilities to provide ultrapure
dialysate in the future should an evidentiary basis be solidified. A
few comments suggested that if we require ultrapure dialysate, Medicare
should provide corresponding reimbursement.
Response: We appreciate the comments; however, we are not requiring
dialysis facilities to provide ultrapure dialysate in this final rule.
Current information shows promise of ultrapure dialysate, but we
believe that sufficient evidence is lacking. We will revisit this issue
in the future when more evidence is available, recognizing that
dialysis patients are in favor of a lower permissible level of
bacterial contamination in the dialysate. If additional evidence
supports the use of ultrapure dialysate, we may undertake the necessary
rulemaking to incorporate the requirement at a later date. Facilities
choosing to provide ultrapure dialysate must meet section 4.3.2.2 of
the ANSI/AAMI RD52 guidelines.
Comment: Some commenters suggested that we avoid codifying dates
and values in the regulations, as these may change before the
regulation changes.
Response: We believe that the avoidance of values and use of
general language for Medicare patient safety requirements may create
confusion and allow less than full compliance with these conditions for
coverage. There are currently clear thresholds and standards for
dialysis water purity, which we have included. Where necessary, we will
consider updating specific dates and values via future rulemaking, as
appropriate.
Comment: Two commenters pointed out that the AAMI guidelines for
bacteria and bacterial toxin sample sites were misquoted in the
proposed rule preamble bullets (70 FR 6195) as follows:
Outlet of the water storage tanks if used
Concentrate or from the bicarbonate concentrate mixing
tank.
Response: The commenters are correct. The bullets above do not
accurately reflect the guidelines. However, the language will not
appear in this final rule since the issue is covered in ANSI/AAMI RD52;
section 7.2.1 (page 25), incorporated by reference at Sec. 494.40(a)
in this final rule, which addresses collection sites for water/
dialysate samples.
Comment: One commenter stated that the final rule should require a
water quality technician who would be independent from the primary
caregivers.
Response: Provisions regarding the water treatment system
technicians are found at Sec. 494.140(f); water treatment system
technicians must complete a training program that has been approved by
the medical director and governing body. Section 9 of AAMI RD52 calls
for a training program that includes ``quality testing, the risks and
hazards of improperly prepared concentrate, and bacterial issues.''
Section 9 also states, ``Operators should be trained in the use of the
equipment by the manufacturer or should be trained using materials
provided by the manufacturer. The training should be specific to the
functions performed (that is, mixing, disinfection, maintenance, and
repairs). Periodic audits of the operators' compliance with procedures
should be performed. The user should establish an ongoing training
program designed to maintain the operator's knowledge and skills.'' The
dialysis facility has flexibility with staff assignments and the water
quality technician may or may not be independent of the primary
caregivers. As noted, we are incorporating these provisions by
reference.
Comment: One commenter objected to the RO/deionization component
requirement at Sec. 494.40(b), which it believed could preclude use of
new/improved technologies.
Response: We have removed this language from Sec. 494.40(b). At
Sec. 494.40(a), we have incorporated by reference ANSI/AAMI RD52,
which states in section 5, ``Equipment'' (page 8):
Since feed water quality and product water requirements may vary
from facility to facility, not all of the components described in
the following clauses will be necessary in every purification and
distribution system. Components must be included, which would allow
product water and dialysate to meet the AAMI standards specified at
4.1.2, 4.2.1, and 4.3.2.1.
Comment: One commenter objected to the requirement to assay
cultures within 24 hours since this may not be realistic on weekends.
The commenter suggested allowing a 48-hour time period for cultures.
Response: The proposed rule did not prescribe culture assay
timelines. However, the ANSI/AAMI RD52 guidelines at section 7.2.3
state that samples that cannot be cultured within 1-2 hours can be
refrigerated for up to 24 hours. Samples that are held longer than 24
hours do not accurately measure
[[Page 20382]]
the degree of contamination against the established AAMI standards. We
have incorporated ANSI/AAMI RD52 standards into this final rule by
reference at Sec. 494.40(a).
Comment: One comment stated that facilities should be able to
substitute a reuse water sample from the site where the dialyzer
connects to the reuse system for a sample taken from the entrance to
the reprocessing equipment (described at 70 FR 6195).
Response: AAMI specifies collection of water samples from the
outlets supplying the reuse equipment (ANSI/AAMI RD52 section 6.3.3,
page 22). We will adhere to this AAMI guideline. We have incorporated
ANSI/AAMI RD52 by reference at Sec. 494.40(a) in this final rule.
Comment: One commenter suggested the requirement for a water sample
at the outlet of the water storage tank be deleted, since this is only
necessary initially and when trouble-shooting.
Response: The commenter refers to proposed rule preamble language
(70 FR 6195) describing RD52 sample sites and is correct in observing
that samples are taken from the outlet of the water storage only
initially and when troubleshooting. This matter is addressed in section
7.2.1 of AAMI RD52, which we are incorporating into this final rule by
reference.
Comment: One commenter stated that when referring to water samples
from the distribution ``loop'' we should change our wording, as a
``loop'' has no ``beginning'' or ``end''.
Response: We refer the commenter to AAMI RD52 section 6.3.3 (page
22), which states that samples should be taken from the first and last
outlets of the water distribution loop and the outlets supplying the
reuse equipment and bicarbonate mixing tanks. We have incorporated
ANSI/AAMI RD52 by reference at Sec. 494.40(a) into this final rule. We
believe that the AAMI language is generally understood.
Comment: We received comments regarding the quality of home
hemodialysis water, recommending that there be separate water purity
standards for home dialysis systems due to the availability of new
technology and the cost burden associated with the proposed water
quality requirements.
Response: We acknowledge that the AAMI RD52 water and dialysate
purity guidelines were not intended by AAMI for home dialysis or
portable systems. However, in the absence of water purity guidelines
for home hemodialysis, we believe that the AAMI RD52 water and
dialysate purity guidelines offer the best protection for use in
preconfigured systems.
Therefore, the dialysis facility must monitor the quality of water
and dialysate used by home hemodialysis patients, and conduct an onsite
evaluation and testing of the water and dialysate system. The water and
dialysate monitoring must be in accordance with the system's
manufacturer instructions at Sec. 494.100(c)(1)(v)(A), and the
system's FDA approved labeling for preconfigured systems designed,
tested, and validated to meet AAMI quality (which includes standards
for chemical and chlorine/chloramine testing) water and dialysate. The
facility must meet testing and other requirements of AAMI RD52:2004 for
water and dialysate. In addition, bacteriological and endotoxin testing
must be performed at least quarterly, or on a more frequent basis, as
needed, to ensure that the water and dialysate are within AAMI
standards at Sec. 494.100(c)(1)(v)(B).
In cases where these new preconfigured hemodialysis machines are
used in a dialysis facility, the home dialysis requirements do not
apply. Therefore, we have added the following language at Sec.
494.40(e) to address in-center use of these machines: ``When using a
preconfigured, FDA-approved hemodialysis system designed, tested, and
validated to yield AAMI-quality (which includes standards for chemical
and chlorine/chloramine testing) water and dialysate, the system's FDA-
approved labeling must be adhered to for machine use and monitoring of
the water and dialysate quality. The facility must meet AAMI RD52:2004
requirements for water and dialysate. However, the facility must
perform bacteriological and endotoxin testing on a quarterly or more
frequent basis, as needed, to ensure that the water and dialysate are
within AAMI limits.''
Comment: One commenter recommended that we require facilities to
use only certified labs for analysis of bacteria growth and limulus
amoebocyte lysate (LAL) testing.
Response: We are aware that many facilities do their own water and
dialysate cultures and endotoxin testing on-site. The AAMI RD52
guidelines address the monitoring of water and dialysate systems for
bacteria and endotoxin levels. Section 7.2.3 states that ``Dip samplers
may be used for bacterial surveillance. However, they should be used
only in conjunction with a quality assurance program designed to ensure
their appropriate use.'' Section 7.2.4 addresses in-house testing for
endotoxin levels. We have not modified the requirements as the RD52
document provides guidance regarding cultures and endotoxin testing.
c. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
We proposed to update our condition for coverage at Sec. 405.2150,
``Reuse of hemodialyzers and other dialysis supplies'', by replacing it
with a new condition for coverage at Sec. 494.50. The ANSI/AAMI
``Reuse of Hemodialyzers'' guidelines (ANSI/AAMI RD47: 1993, second
edition), incorporated by reference in 1995, were revised in 2002 and
amended in 2003. We proposed incorporation by reference of the third
edition of ``Reuse of Hemodialyzers'' (ANSI/AAMI RD47: 2002/A1: 2003).
We proposed that only hemodialyzers and bloodlines labeled for reuse
could be reprocessed and that reprocessing would have to meet the AAMI
guidelines and adhere to the manufacturer's recommendations, unless an
alternate method, documented to be safe and effective, was employed.
The prohibition on reuse of hemodialyzers for hepatitis B patients was
retained in the proposed rule, to protect staff from exposure to the
hepatitis B virus. The requirement that the facility use only one
germicide for each reprocessed hemodialyzer was retained in the
proposed rule, to ensure integrity of the dialyzer membrane; we added a
clarification that bleach would not be considered a germicide in this
context. We proposed monitoring, evaluation, and reporting requirements
to ensure surveillance for adverse patient reactions to reuse, and
proposed that the facility suspend reuse when a problem was suspected
or discovered. We also proposed that when required by law, adverse
outcomes would have to be reported to the FDA and other Federal, State,
or local government agencies.
We received more than two dozen comments on the Reuse condition.
The comments support inclusion of the updated 2002/2003 AAMI ``Reuse of
hemodialyzers'' guidelines.
Comment: Several commenters addressed the first provision of this
condition, which states, ``The dialysis facility that reuses
hemodialyzers or bloodlines must meet the requirements of this section.
Failure to meet any of these requirements constitutes grounds for
denial of payment for the dialysis treatment affected and termination
from participation in the Medicare program.'' Some of the commenters
suggested deletion of this statement, while others suggested stronger
penalties. One commenter stated this statement merely repeated proposed
Sec. 488.604, while another suggested the penalty was too drastic.
Response: The language regarding penalties for failure to meet the
reuse
[[Page 20383]]
requirements is consistent with section 1881(f)(7) of the Act, which
directly addresses dialyzer filter reuse. However, denial of payment
for discrete instances of reuse non-compliance, authorized by section
1881(f)(7)(C) of the Act, has not been implemented, due to
administrative difficulties associated with identifying which
particular treatments would be associated with any specific denial of
payment when there is a reuse problem. Currently, when a compliance
problem is identified, the surveyor cites the facility and the facility
must develop and implement a corrective action plan. If the facility
does not make the necessary corrections then the facility is put on a
termination track. This process has been effective in protecting
patient health and safety when hemodialyzers are reused and will
continue under this final rule. Therefore, we have removed the
undesignated paragraph ``Failure to meet any of these requirements
constitutes grounds for denial of payment for the dialysis treatment
affected and termination from participation in the Medicare program''
from Sec. 494.50.
We believe dialysis facility termination for reuse deficiencies and
non-compliance fulfills the statutory requirement at section
1881(f)(7)(C) of the Act, that CMS deny payment for hemodialyzer reuse
non-compliance. Under the current process, when a reuse problem is
confirmed by a surveyor, we require immediate corrective action, which
protects patient safety. If the reuse problem presented immediate
jeopardy to patient safety, we would shut down the reuse program
immediately until the facility could demonstrate that the problem had
been corrected. CMS also has the authority to withhold payment from a
facility when it has determined that there have been specific
violations of this provision. If the facility were to continue to
compromise patient safety, we would put the facility on a termination
track. We believe that termination procedures provide more incentive to
return to compliance than the denial of payment alternative sanction.
Comment: One commenter asked how the proposed rule ensures patient
consent for dialyzer reuse.
Response: Our requirement for patient consent for dialysis reuse is
located at Sec. 494.70(a)(9), which states the patient has the right
to be informed of facility policies regarding the reuse of dialysis
supplies, including hemodialyzers. Patients may want to discuss this
aspect of their medical treatment with their physician.
Comment: An organization representing kidney disease patients
expressed concern regarding the large number of times a hemodialyzer is
reused (up to 30 times), and requested that CMS convene a technical
expert panel to examine all facets of reuse and make recommendations to
improve current practice.
Response: We have added incorporation by reference the AAMI reuse
guidelines, ANSI/AAMI RD47:2002 & RD47:2002/A1:2003 ``Reuse of
hemodialyzers'' to this final rule at Sec. 494.50(b)(1). The AAMI
guidelines, which represent the consensus of technical experts, include
dialyzer performance measurements (that is, total cell volume) that
must be met in order for a dialyzer to be reused. Currently these
parameters do not include a maximum number of allowable reuses. We may
consider updates to this final rule through separate rulemaking when
AAMI updates its reuse guidelines.
Comment: A few commenters disagreed with some of the AAMI
hemodialyzer reuse guidelines. One commenter recommended that we
require immediate disinfection of dialyzers and not allow the
refrigeration of dialyzers; another commenter suggested that we ban the
reuse of bloodlines, since AAMI is withdrawing the bloodline reuse
guidelines. A third commenter recommended that dialyzer heat
disinfection be prohibited.
Response: We defer to the AAMI guidelines on each of these reuse
issues. Section 11 of the AAMI reuse guidelines, ANSI/AAMI RD47:2002 &
RD47:2002/A1:2003 ``Reuse of hemodialyzers,'' incorporated into this
final rule by reference, describes the approved processes for cleaning
and disinfecting dialyzers, including heat disinfection. The guidelines
also permit refrigeration of hemodialyzers that cannot be reprocessed
within 2 hours, in order to inhibit bacterial growth. The AAMI
guidelines allow disinfection procedures that have been shown to
accomplish at least high-level disinfection when tested in dialyzers
artificially contaminated with the relevant types of microorganisms.
The guidelines also state that the disinfection process shall not
adversely affect the integrity of the dialyzer. To date, AAMI has not
rescinded the bloodline reuse guidelines and this final rule requires
facilities that reuse bloodlines to follow them.
Comment: Two commenters recommended a further clarification of the
requirement we proposed at Sec. 494.50(b)(3), which stated that
facilities will ``Not expose hemodialyzers to more than one chemical
germicide, other than bleach, during the life of the dialyzer.'' One
suggestion was to insert a clarifying parenthetical phrase so that this
requirement would read, ``Not expose hemodialyzers to more than one
chemical germicide, other than bleach (used as a cleaner in this
application), during the life of the dialyzer.'' This commenter
suggested that without adding this phrase the statement would be
misleading, as it implied that bleach could be used as a disinfectant,
which could damage the dialyzer if used long-term in such a manner.
Response: We agree with the commenter. We have revised Sec.
494.50(b)(3) to clarify that bleach is considered a ``cleaner'' and not
a disinfectant in this context.
Comment: We received a few comments regarding Sec. 494.50(c),
``Monitoring, evaluation, and reporting requirements for the reuse of
hemodialyzers and bloodlines.'' Some commenters recommended clarifying
the phrase ``cluster of adverse patient reactions'' and two commenters
supported a requirement that a blood test be done whenever a febrile
reaction occurs, not just when there is a cluster. Another commenter
cited a 1987 study published in the Journal of the American Medical
Association that established a direct relationship between endotoxin
levels and febrile reactions caused by poor reuse reprocessing
techniques and recommended that endotoxins be measured in addition to
blood and dialysis cultures since cultures may be negative with high
endotoxin levels.
Response: ``A cluster of adverse patient reactions'' means a set of
undesirable events affecting the health of dialysis patients that could
be clinically related to dialyzer reuse practices. In such cases, the
physician responsible for the hemodialyzer reprocessing program must
act in accordance with the AAMI guidelines found at ANSI/AAMI RD47:2002
& RD47:2002/A1:2003. If a single patient has a suspected adverse
reaction, the physician should evaluate the incident and order testing
as appropriate in his or her clinical judgment.
The requirements of section 494.50(c) (regarding obtaining blood
and dialysate cultures and evaluation of dialyzer reprocessing and
water purification systems) would apply if a group of patients (that
is, a cluster) was suspected of having adverse reuse reactions. We
agree with the commenter that facility personnel should perform
dialysate endotoxin level tests along with dialysate cultures when a
[[Page 20384]]
suspected adverse event occurs; this is consistent with our requirement
in the ``Adverse events'' standard in the ``Water and dialysate
quality'' condition at Sec. 494.40. Therefore we have added endotoxin
testing requirements at Sec. 494.40(d)(1) and Sec. 494.50(c)(2)(i).
A dialysis facility that uses outside hemodialyzer reprocessing
services is responsible for fully protecting patient health and safety
and ensuring compliance with these conditions for coverage and AAMI
reuse guidelines as well as carrying out appropriate testing and
evaluation of reuse processing and water purification systems when a
cluster of adverse events occurs.
d. Physical Environment (Proposed Sec. 494.60)
We proposed to update the Sec. 405.2140 ``Physical environment''
requirements, which address facility building safety, equipment
maintenance, the patient care environment, emergency preparedness, and
fire safety, at new Sec. 494.60. The proposed rule was consistent with
part 405, subpart U provisions in requiring that a facility be
constructed, equipped, and maintained to provide dialysis patients,
staff, and the public a safe, functional, and comfortable environment.
The proposed rule further addressed patient comfort by requiring that
the facility temperature be comfortable for the majority of its
patients or that reasonable accommodations be offered. We proposed that
the dialysis facility implement processes and procedures to manage
medical and nonmedical emergencies (including fire, equipment or power
failures, care-related emergencies, water supply interruption, and
natural disasters) that are likely to threaten the health or safety of
the patients, the staff, or the public. The proposed rule would require
emergency preparedness training for staff and patients, and would
specify the emergency equipment that would have to be available in the
dialysis facility (including oxygen, airways, suction, defibrillator,
artificial resuscitator, and emergency drugs). The proposed fire safety
requirements called for facility compliance with applicable provisions
of the 2000 edition of the LSC of the National Fire Protection
Association. The LSC waiver provisions were included in the proposed
rule for those instances when, in the view of CMS, LSC compliance would
result in unreasonable hardship and patient health and safety would not
be adversely affected; or when a State had fire and safety codes that
adequately protected dialysis patients. For a detailed discussion of
our proposed physical environment provisions at Sec. 494.60, see the
February 4, 2005 proposed rule (70 FR at 6197).
Comment: Under the ``Equipment maintenance'' standard at Sec.
494.60(b), one commenter suggested that equipment be maintained
according to a regular maintenance schedule rather than the
manufacturer's recommendations. The commenter was concerned that the
manufacturer might overstate the amount of maintenance required.
Response: Our intent was to ensure that all dialysis facility
equipment was adequately maintained and working properly. We proposed
that ``The dialysis facility must implement and maintain a program to
ensure that all equipment (including emergency equipment, dialysis
machines and equipment, and the water treatment system) is maintained
and operated in accordance with the manufacturer's recommendations.''
It is expected that routine maintenance be performed so that the risk
of equipment malfunction is small. The facility will need to use the
manufacturer's recommendations as a reference and guide. We have
retained Sec. 494.60(b) as proposed.
Comment: While the majority of commenters support our proposed
requirement at Sec. 494.60(c)(2) (that the facility maintain a room
temperature that would be comfortable for patients, and make reasonable
accommodations for the patients who might not be comfortable at the
temperature that is comfortable for the majority), several commenters
disagreed with this requirement. Some thought the proposal was too
prescriptive, ignored the needs of staff (who are required to wear
protective clothing), and allowed patients to dictate staff working
conditions. Commenters noted that facilities already strive to keep
patients comfortable, and stated that patients should be educated as to
why body temperature drops during dialysis.
Response: Room temperature is a source of frequent tension in a
hemodialysis facility. Generally, the sedentary patients undergoing
treatment prefer a warmer room temperature, while staff who are engaged
in activity and wearing protective coverings prefer a cooler room
temperature. The proposed requirement would have tilted the room
temperature in favor of the patients without consideration of the needs
of the staff. In response to comments, we have modified the requirement
to acknowledge the room temperature needs of staff. The intent of the
new requirement is to have facilities arrive at a middle ground so that
the room temperature is at least marginally acceptable to both patients
and staff. Patients who continue to feel cold could use coverings or
blankets. Regardless of the room temperature, patients should not be
deprived of the ability to use covers or blankets. The dialysis
facility may allow patients to bring their own blanket or may opt to
provide a cover. In either case, adequate infection control precautions
must be taken considering the risk of blood spatter. Additionally, the
access sites and line connections should remain uncovered to allow
staff to visually monitor these areas to ensure patient safety. In
response to comments, we have revised Sec. 494.60(c)(2)(i) by removing
the phrase ``that is comfortable for the majority of its patients'' and
inserted the word ``comfortable'' earlier in the sentence. Section
Sec. 494.60(c)(2)(i) and Sec. 494.60(c)(2)(ii) now requires a
facility to maintain a comfortable temperature within the facility; and
make reasonable accommodations for the patients who are not comfortable
at this temperature.
Comment: Many commenters recommended that we add privacy
requirements to allow facility staff to conduct confidential interviews
with patients, and to ensure that facilities utilized physical barriers
whenever body exposure necessitated usual privacy. Commenters who
supported a confidential area for patient interviews cited the April
14, 2003 Health Insurance Portability and Accountability Act (HIPAA)
fact sheet (http://www.hhs.gov/news/facts/privacy.html) which outlines
patient information privacy protections, including the patient's right
to request confidential communications.
Response: HIPAA requirements protecting patient privacy apply to
dialysis facilities. Two provisions of the proposed rule would support
the patient's right to privacy. Proposed paragraph Sec. 494.70(a)(3)
stated that the patient would have the right to privacy and
confidentiality in all aspects of treatment. Likewise, proposed Sec.
494.70(a)(4), stated that the patient would have the right to privacy
and confidentiality in personal medical records. Our preamble
discussion of this requirement in the proposed rule (70 FR 6201)
clearly stated our belief that any staff discussion with dialysis
patients regarding treatment, the patient care plan, and medical
conditions should be held in private and kept confidential, using
reasonable precautions. We also pointed out that in situations when
there was patient body exposure, the staff would be instructed to
provide temporary screens, curtains, or blankets to protect patient
privacy. To respond to these comments and to further
[[Page 20385]]
strengthen the patient's right to physical privacy, we have added a new
provision at Sec. 494.60(c)(3), stating that ``The dialysis facility
must make accommodations to provide for patient privacy when patients
are examined or treated and body exposure is required.'' This provision
also protects those patients who do not wish to intrude on another
patient's privacy.
Comment: Several commenters objected to the deletion of the
centralized nursing monitoring station requirement in the proposed
rule, formerly at Sec. 405.2140(b)(3), as they believe a monitoring
station is needed to support adequate surveillance of patients
receiving dialysis. One commenter suggested that patient call buttons
be required. Another commenter suggested retaining the concept of the
nursing station requirement by adding the language, ``Patients should
be in view of staff at all times during treatment to ensure patient
safety.''
Response: We had proposed deleting the centralized nursing station
requirement in order to increase facility flexibility in designing the
clinical area. Patients undergoing hemodialysis require surveillance
and continuous monitoring. Without vigilant monitoring it is possible
for a dialysis needle to become dislodged, which could result in
patient death from blood loss in just minutes. The suggested call
button would place responsibility on the patient to alert staff to a
problem; however, we expect continual monitoring of the patient, which
would make a call button unwarranted. We are not restoring the
requirement for a ``nursing station'' to allow maximum facility
flexibility, but will require staff surveillance of in-center
hemodialysis patients during treatment. Therefore, we have added a new
provision at Sec. 494.60(c)(4), ``Patients must be in view of staff
during hemodialysis treatment to ensure patient safety (video
surveillance will not meet this requirement).''
Comment: We received several comments regarding ``Emergency
preparedness'' at Sec. 494.60(d). Two commenters objected to having
specific types of emergencies ``spelled out'' in regulation while
another commenter recommended that bioterrorism be added to the list of
emergencies for which facilities would be required to be prepared.
Response: In the proposed rule, the list of emergencies at Sec.
494.60(d) for which dialysis facilities must be prepared ``include, but
are not limited to, fire, equipment or power failures, care-related
emergencies, water supply interruption, and natural disasters likely to
occur in the facility's geographic area.'' This list clarifies for
facilities what types of emergencies must be addressed in the emergency
plans. Facilities may prepare for many types of emergencies, including
bioterrorism, which are identified as a risk after the performance of a
facility risk assessment. We are retaining the proposed list of
emergencies in this final rule.
Comment: Some commenters concurred with the standard as proposed.
Two commenters advocated for a back-up generator requirement. Others
requested clarification of proposed requirement for periodic training
of staff and patients.
Response: The proposed emergency preparedness standard was designed
to allow dialysis facilities maximum flexibility in meeting our
requirements, which could include a back-up generator or other means of
supplying needed power to the facility.
As for training, our final staff training requirements (Sec.
494.60(d)(1)) state that the dialysis facility must ``provide
appropriate training and orientation in emergency preparedness to the
staff. Staff training must be provided and evaluated at least annually
* * *.'' The regulation goes on to specify what topics must be included
in the training and the patients' instruction. The frequency of this
training must be sufficient so that staff and patients are able to
implement emergency procedures at any time. We are adopting Sec.
494.60(d) introductory text and Sec. 494.60(d)(1) introductory text as
proposed. We believe this addresses the commenter's concern.
Comment: After the tragic hurricane events of 2005 (Hurricanes
Katrina, Rita, and Wilma) we received some additional comments and
recommendations from the national ESRD disaster response workgroup
related to natural disaster preparedness, as these experiences led to
new ``lessons learned.'' One recommendation was to add a requirement
that would enable patients to contact their dialysis facility during a
disaster, such as requiring each facility to provide an emergency toll-
free phone number where patients could obtain critical medical
information. A second recommendation was to include evacuation
procedures in the disaster plan. A third recommendation was to require
not only a plan, but also to require facilities to have a procedure in
place to obtain back-up utilities, including agreements with utility
companies for water and energy. A fourth suggestion was to require
dialysis facilities to contact local disaster management officials at
least annually, to ensure that local disaster aid agencies were aware
of the dialysis facility's patients' needs in the event of an
emergency.
Response: The final emergency preparedness standard includes
requirements for the emergency preparedness of staff and patients and
addresses instructions that are provided to dialysis patients. We have
revised Sec. 494.60(d)(1)(i)(B) to require that staff inform patients
of where to go during an emergency, including evacuation instructions
for emergencies in which geographic area of the dialysis facility must
be evacuated.
We believe it is reasonable for dialysis facilities to provide an
alternate phone number if the phone is not being answered, and/or the
facility is not functioning during a disaster. We have added this
requirement at Sec. 494.60 (d)(1)(i)(C). This additional requirement
reads, ``This contact information must include an alternate emergency
phone number for the facility for instances when the dialysis facility
is unable to receive phone calls due to an emergency situation (unless
the facility has the ability to forward calls to a working phone number
under such emergency conditions) * * *.''
A disaster plan must include procedures and processes for use in
the event of power or water source loss, or a disaster that would make
the dialysis facility inoperable. We believe that it is reasonable for
a dialysis facility to establish at least annual contact with its local
disaster management agency to ensure that the agency is aware of the
dialysis facility's needs in the event of an emergency. This pre-
emptive contact could facilitate the meeting of dialysis patient needs
during a disaster. We have added a new provision, codified at Sec.
494.60(d)(4)(iii), requiring the dialysis facility to, ``Contact its
local disaster management agency at least annually to ensure that such
agency is aware of dialysis facility needs in the event of an
emergency.''
We did not modify the final rule in response to the disaster
response workgroup's recommendation that we require facilities to have
a procedure in place to obtain back-up utilities, including agreements
with utility companies for water and energy. This final rules requires
that dialysis facilities develop an emergency plan that addresses
emergency situations that may occur. These emergencies include power
failure and water supply problems. The dialysis facility has
flexibility in designing an emergency plan for these types of
emergencies. The plan may include agreements with utility companies or
alternative
[[Page 20386]]
interventions. We will not prescribe the methods that must be employed
in responding to the various types of emergencies. The emergency plan
must provide sufficient guidance to staff in preparing for emergencies
and carrying out the plan.
Comment: A few comments were specific to proposed Sec.
494.60(d)(1)(iii), requiring the facility to ensure that nursing staff
are properly trained in the use of emergency equipment and emergency
drugs. Two commenters objected to such nurse training, because it
``placed an emergency room-type burden on them.'' Other commenters
suggested that the relevant emergency drugs be specified, and that
suction devices be specifically excluded from the definition of
``emergency equipment.''
Response: We believe it is reasonable for dialysis facility nurses
to be trained and prepared to handle emergencies that are likely to
occur within the dialysis facility, and to require the facility to have
equipment available for treating these emergencies. Suction machines
are necessary medical devices used to clear a patient's airway of
secretions or vomit. In the absence of these medical devices, it is
possible that the patient's airway could not be cleared. Therefore, we
are not deleting this requirement. The specific emergency drugs that
are to be available should be determined by the medical director and
described in the facility's policies and procedures. We are making no
changes based on these comments.
Comment: We received many comments regarding the proposed
defibrillator requirement at Sec. 494.60(d)(3). The vast majority of
commenters support inclusion of a defibrillator requirement, but
recommended that an automated external defibrillator (AED) be an
acceptable option. Commenters stated that AEDs were preferable because
they are easy to use, more affordable, and do not require the extensive
Advanced Cardiac Life Support (ACLS) training and certification that a
non-automated defibrillator would require. Commenters did not support a
defibrillator exception for small rural dialysis facilities, stating
that these more remote facilities do not have nearby emergency medical
services (EMS) and have a greater need for an in-house AED. A few
commenters objected to the defibrillator requirement because they saw
this as an unfunded mandate. One commenter said defibrillators should
only be required if Medicare funds them, while another dissenting
commenter said the need for a defibrillator should be based on the
facility's proximity to EMS. The American Heart Association (AHA)
commented on this issue and strongly supported a defibrillator
requirement and AEDs in dialysis units, and suggested that AED training
be combined with cardiopulmonary resuscitation training. The AHA
pointed out that defibrillators have been shown to save lives in a
variety of settings including office buildings, airplanes, and
stadiums, where survival rates without AEDs are otherwise 1 percent.
The AHA also noted that cardiac disease accounts for 43 percent of
deaths in ESRD patients (United States Renal Data System 2003 Annual
Data Report). The AHA recommended no exemptions for small, rural units
but suggested a 1-year phase-in period for these types of dialysis
facilities.
Response: We received substantial support from commenters for
requiring a defibrillator, specifically an AED. In response to
comments, we will require a defibrillator or an automated external
defibrillator in our ``Emergency equipment'' standard at Sec.
494.60(d)(3). However, we are not allowing a ``1-year phase-in period''
for small, rural units as suggested by one commenter. This is because
we believe that a small, rural unit is likely to be further from
emergency services and/or ambulance services, and as such, we believe
that having a defibrillator or AED on hand would greatly increase the
chance of survival for a dialysis patient in the event of a cardiac
arrest. We believe that facilities will have sufficient time to
purchase a defibrillator or AED and to train staff, since this
regulation is effective 180 days after publication in the Federal
Register.
Comment: We received many comments on proposed Sec. 494.60(e)
``Fire safety.'' Several commenters concurred with the standard as
proposed. We received many comments objecting to the proposed LSC
provisions that require sprinklers and central monitoring systems in
dialysis facilities. The commenters felt that LSC provisions should
apply only to new facilities that are built after the effective date of
the final rule. Several commenters felt that requiring the installation
of sprinkler and a central monitoring system would be costly and
burdensome. Some stated this could impose excessive burdens on leased
dialysis facilities, building landlords, multi-story buildings and
multi-tenant buildings, where sprinkler systems would need to be
installed in a general retrofit for the entire structure. Commenters
stated that since existing dialysis facilities occupied buildings that
met the building codes in effect at the time of construction, they
should be grandfathered for the 2000 LSC requirements, as long as State
codes were met.
Response: The proposed LSC requirements provide significantly
greater protection to dialysis patients than the fire protection
provisions of part 405, subpart U at Sec. 405.2140(a) and Sec.
405.2140(c). Commenters objected most strongly to the LSC requirement
for a sprinkler system in certain existing buildings. The 2000 LSC only
requires buildings with certain structural configurations to have
sprinkler systems. Specifically, 2000 LSC requires that only Type II
(000) and ordinary constructed Type III (200) buildings, and Type V
(000) buildings of two or more stories must be protected throughout by
an approved, supervised automatic sprinkler system (2000 LSC section
21.1.6.3). We acknowledged in the proposed rule preamble that for some
existing dialysis facilities it could be overly burdensome to comply
with certain LSC requirements, and provided the sprinkler requ