[Federal Register: February 4, 2005 (Volume 70, Number 23)]
[Proposed Rules]
[Page 6183-6254]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe05-28]
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Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 400, 405, 410, et al.
Medicare Program; Conditions for Coverage for End Stage Renal Disease
Facilities; Proposed Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
42 CFR Parts 400, 405, 410, 412, 413, 414, 488, and 494
[CMS-3818-P]
RIN 0938-AG82
Medicare Program; Conditions for Coverage for End Stage Renal
Disease Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise the requirements that end
stage renal disease (ESRD) dialysis facilities must meet to be
certified under the Medicare program. The revised requirements focus on
the patient and the results of the care provided to the patient,
establish performance expectations for facilities, encourage patients
to participate in their care plan and treatment, eliminate many
procedural requirements from the current conditions for coverage, and
preserve strong process measures when necessary to promote patient well
being and continuous quality improvement. These changes are necessary
to reflect the advances in dialysis technology and standard care
practices since the requirements were last revised in their entirety in
1976.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 5, 2005.
ADDRESSES: In commenting, please refer to file code CMS-3818-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (fax) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments.
(Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3818-P, PO Box 8012, Baltimore, MD
21244-8012.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Robert Miller (410) 786-6797, Teresa
Casey (410) 786-7215, and Rachael Weinstein (410) 786-6775 (Conditions
for Coverage and Quality Standards). Jan Tarantino, (410) 786-0905
(Survey and Certification).
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-3818-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. After the close of the
comment period, CMS posts all electronic comments received before the
close of the comment period on its public website. Comments received
timely will be available for public inspection as they are received,
generally beginning approximately 3 weeks after publication of a
document, at the headquarters of the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an
appointment to view public comments, phone 1-800-743-3951.
Copies: To order copies of the Federal Register containing this
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and photocopy the Federal Register document at most libraries
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This Federal Register document is also available from the Federal
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Government Printing Office. The Web site address is: http://www.gpoaccess.gov/fr/index.html
.
Table of Contents
I. Introduction and the Provision of Reference Materials
II. Background
A.History
B. Existing ESRD Regulations
C. Overview
D. Establishment of Central Requirements
E. Development of Outcome-Based Performance Quality Measures
1. Dialysis Facility Compare
2. Dialysis Facility Data Reporting Requirements
3. Facility Specific Reports
4. The National Kidney Foundation Kidney Disease Outcomes
Quality Initiative (NKF-K/DOQI) Clinical Practice Guidelines
5. CMS ESRD Clinical Performance Measures Project
6. CPM Data Reporting
7. Updating Existing ESRD Patient-Specific Performance Measures
and Developing Future ESRD Facility Performance Standards
F. Summary of the Contents of the Proposed Rule
III. Provisions of Proposed Part 494 Subpart A (General Provisions)
A. Basis and Scope (Proposed Sec. 494.1)
B. Definitions (Proposed Sec. 494.10)
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C. Compliance with Federal, State, and Local Laws and
Regulations (Proposed Sec. 494.20)
IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)
A. Infection Control (Proposed Sec. 494.30)
B. Water Quality (Proposed Sec. 494.40)
C. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
D. Physical Environment (Proposed Sec. 494.60)
V. Provisions of Proposed Part 494 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)
1. Development of the Patient Plan of Care (Proposed Sec.
494.90(a))
a. Dose of Dialysis (Proposed Sec. 494.90(a)(1))
b. Nutritional Status (Proposed Sec. 494.90(a)(2))
c. Anemia (Proposed Sec. 494.90(a)(3))
d. Vascular Access (Proposed Sec. 494.90(a)(4))
e. Transplantation Status (Proposed Sec. 494.90(a)(5))
f. Rehabilitation Status (Proposed Sec. 494.90(a)(6))
g. Social Services
2. Implementation of the Patient Plan of Care (Proposed Sec.
494.90(b))
3. Transplantation Referral (Proposed Sec. 494.90(c))
4. Patient Education and Training (Proposed Sec. 494.90(d))
D. Care at Home (Proposed Sec. 494.100)
1. Dialysis of ESRD Patient in the Home Setting
2. Dialysis of ESRD Patients in Nursing Facilities and Skilled
Nursing Facilities
a. Delineation of Responsibility
b. Applicable ESRD Conditions for Coverage
c. Nursing Coverage
d. Training
e. Monitoring
E. Quality Assessment and Performance Improvement (Proposed
Sec. 494.110)
1. Program Scope (Proposed Sec. 494.110(a))
2. Monitoring Performance Improvement (Proposed Sec.
494.110(b))
3. Prioritizing Improvement Activities (Proposed Sec.
494.110(c))
4. Facility Specific Standards of Enforcement
F. Special Purpose Renal Dialysis Facilities (Proposed Sec.
494.120)
G. Laboratory Services (Proposed Sec. 494.130)
VI. Provisions of Proposed Part 494 Subpart D (Administration)
A. Personnel Qualifications (Proposed Sec. 494.140)
1. Medical Director (Proposed Sec. 494.140(a))
2. Nursing Services (Proposed Sec. 494.140(b))
3. Dietitian (Proposed Sec. 494.140(c))
4. Social Worker (Proposed Sec. 494.140(d))
5. Patient Care Dialysis Technicians (Proposed Sec. 494.140(e))
6. Other Personnel Issues
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)
1. Existing Requirements for Governing Bodies
2. Overview of the Proposed Governance Requirements
3. Governance Condition (Proposed Sec. 494.180)
4. Designating a Chief Executive Officer or Administrator
(Proposed Sec. 494.180(a))
5. Adequate Number of Qualified and Trained Staff (Sec.
494.180(b))
6. Medical Staff Appointments (Proposed Sec. 494.180(c))
7. Furnishing Services (Proposed Sec. 494.180(d))
8. Internal Grievance Process (Proposed Sec. 494.180(e))
9. Discharge and Transfer Policies and Procedures (Proposed
Sec. 494.180(f))
10. Emergency Coverage (Proposed Sec. 494.180(g))
11. Furnishing Data and Information for ESRD Program
Administration (Proposed Sec. 494.180(h))
12. Disclosure of Ownership (Proposed Sec. 494.180(i))
VII. Other Proposed Changes
A. Proposed Cross-Reference Changes
B. Proposed Additions to Part 488
VIII. Reference Materials
A. New Provisions in Part 494
B. ESRD Crosswalk
C. Bibliography
IX. Collection of Information Requirements and Public Comments
A. Collection of Information Requirements
B. Response to Comments
X. Regulatory Impact Analysis
Regulations Text
Acronyms
AKF American Kidney Fund
AAMI Association for the Advancement of Medical Instrumentation
ANNA American Nephrology Nurses Association
AHRQ Agency for Healthcare Research and Quality
AED Automatic external defibrillator
AIA American Institute of Architects
ANSI American National Standards Institute
BBA Balanced Budget Act of 1997
BONENT Board of Nephrology Nursing Examiners Nursing and Technology
BUN Blood urea nitrogen
CAHPS Consumer Assessment of Health Plans Survey
CBC Center for Beneficiary Choices
CDC Centers for Disease Control and Prevention
CHI Consolidated Health Informatics
CEO Chief executive officer
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare and Medicaid Services
CPG Clinical practice guidelines
CPM Clinical performance measures
CPR Cardiopulmonary resuscitation
CROWN Consolidated Renal Operations in a Web-enabled Network
DHHS Department of Health and Human Services
DME Durable medical equipment
DOQI Disease Outcomes Quality Initiative
DSN Dialysis Surveillance Network
EMS Emergency medical system
ESRD End stage renal disease
FDA Food and Drug Administration
HHA Home health agency
HIPAA Health Insurance Portability and Accountability Act of 1996
ICH In-center hemodialysis
IOM Institute of Medicine
IT Information technology
LSC Life Safety Code
MedPAC Medicare Payment Advisory Commission
MSW Master's degree social worker
NANT National Association of Nephrology Technicians
NF Nursing facility
NFPA National Fire Protection Association
NIH National Institutes of Health
NISTA National Institute of Standards and Technology Act
NKF National Kidney Foundation
NKF-K/DOQI National Kidney Foundation's Kidney Disease Outcomes
Quality Initiatives
NNCC Nephrology Nursing Certification Commission
NNCO National Nephrology Certification Organization
NQF National Quality Forum
NTTAA National Technology Transfer and Advancement Act of 1995
OBRA 1990 Omnibus Reconciliation Act 1990
OIG Office of the Inspector General
OMB Office of Management and Budget
QAPI Quality assessment and performance improvement
RPA Renal Physicians Association
RRG Rapid response group
SNF Skilled nursing facility
VISION Vital Information System to Improve Outcomes in Nephrology
URR Urea reduction rate
USRDS United States Renal Data System
I. Introduction and the Provision of Reference Materials
A. Introduction
The Centers for Medicare and Medicaid Services (CMS) is committed
to modernizing the existing regulations that are based on largely
procedural standards. One of our key initiatives is to revise many of
the health and safety conditions to focus on the patient's experience
with care in the delivery setting, patient outcomes of care, and the
elimination of unnecessary procedural requirements.
In concert with the Administration's regulatory reform initiative,
we believe that new ESRD regulations should--
Be founded on evidence;
Be patient-centered;
Promote outcomes desired for Medicaid and Medicare
beneficiaries as well as others served by participating ESRD suppliers
of services;
Establish a framework for the collection and reporting of
consensus-driven performance standards;
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Set clear expectations for dialysis facility
accountability; and
Stimulate improvements in processes, outcomes of care, and
beneficiary satisfaction.
In addition, the new ESRD conditions for coverage must comport with
our national performance measurement strategy, which consists of three
principles: (1) Performance measures should be consumer and purchaser-
driven; (2) performance measures should be in general, commonly-used
terms, and their associated collection tools should be generally
available at little or no cost to dialysis facilities; and (3) the
content and collection of data and performance measures derived from
that data should be standardized.
B. Provision of Informational and Review Aids
In our development of the proposed rule, we have included
references to a number of reports, articles, and other documents in the
preamble. To indicate the source of this information, we have provided
a brief parenthetical acknowledgement at the end of referenced
statement and have provided a full citation for the reference in the
bibliography (see section of VIII.C. of this preamble). Other
informational and review aids incorporated in this proposed rule
include--
A table of contents;
A list of acronyms;
A chart listing the new provisions (see section VIII.A. of
this preamble); and
A crosswalk of the existing requirements to the proposed
requirements (see section VIII.B. of this preamble).
II. Background
A. History
ESRD is a kidney impairment that is irreversible and permanent and
requires a regular course of dialysis or kidney transplantation to
maintain life. Dialysis is the process of cleaning the blood
artificially with special equipment when the kidneys have failed.
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 regulations relating to:
The Medicare conditions for coverage for suppliers of ESRD
services;
Certification procedures;
Establishment of minimal utilization rates;
Designation of ESRD network areas;
Establishment of Network Coordination Councils; and
The provision of a Medical Review Board.
A comment period lasting 60 days followed and comments were
carefully considered. 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 reimbursement. In addition,
section 1881(c) of the Act establishes ESRD network areas and network
organizations to assure that dialysis patients are provided appropriate
care.
B. Existing ESRD Regulations
The requirements from section 1881(b), (c), and (f)(7) are
implemented in regulations at 42 CFR 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 and renal transplantation centers
must meet to furnish care to Medicare beneficiaries. The regulations in
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.
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 and kidney transplantation facilities. To determine
if a facility meets these conditions, the State survey agency performs
on-site surveys 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
and kidney transplantation is limited to facilities meeting these
conditions.
Our decision to propose major changes to the existing conditions is
based on several considerations. As discussed above, revising the ESRD
requirements is part of our effort to modernize regulations and move
toward a patient outcome-based system that focuses on quality
assessment and performance improvement. We believe that revising the
conditions for coverage will encourage improvement in outcomes of care
for beneficiaries. Secondly, the existing ESRD conditions were
originally adopted in 1976 and although some amendments have been made
they have not been comprehensively revised since that time. The
existing requirements for dialysis facilities emphasize the policies
and procedures that must be in place to support good patient care, and
they focus on a facility's capacity to furnish quality care, rather
than on the actual provision of quality care to patients and the
outcomes of that care. Third, 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 standards of practice
such as the National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative (NKF-K/DOQI) clinical practice guidelines (CPGs).
The existing ESRD conditions do not require the facility to operate
a patient-centered, outcome-oriented quality assessment and performance
improvement program. Moreover, changes have taken place in the delivery
of services to dialysis patients, and these advances are not reflected
in the existing requirements. Thus, we have concluded that significant
revisions to the conditions for coverage for ESRD facilities are
essential. The proposed changes reflect improvements in standard care
practices, the use of more advanced technology and equipment, and, most
notably, a framework to incorporate performance measures viewed by the
scientific and medical community to be related to the quality of care
provided to dialysis patients.
C. Overview
Since 1994, we have received comments from the renal community at
large and we have used the contributions provided by the community in
developing the revised conditions contained in this proposed rule.
Several renal organizations have offered recommendations regarding the
conditions for coverage during the bimonthly public 2001 and 2002 CMS
meetings on ESRD topics. Notices of
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these were announced on the CMS Web site (http://www.cms.hhs.gov/opendoor/schedule.asp
). We believe that many in the community support
the overall shift in the proposed conditions 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 on the characteristics of ESRD facilities, its
patient population, 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. Thus, the new conditions would invest a
major expectation for performance in a requirement that each facility
participate in its own quality assessment and performance improvement
program. This allows the facility flexibility to create its own self-
tailored program of continuous quality improvement. Facilities could be
flexible and creative in their approach to patient care and delivery of
services as they use their own information to assess and improve
patient services, outcomes, and satisfaction.
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 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.
D. The Establishment of Central Requirements
We are proposing 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
the proposed rule are grouped into three broad categories: (1) Patient
safety; (2) patient care (which includes quality assessment and
performance improvement); and (3) administration. Subpart A contains
general provisions, for example, statutory authority, definitions, and
requirements for compliance with Federal, State and local laws and
regulations. Subparts B (patient safety) and C (patient care) of the
proposed conditions for coverage would focus the facility's efforts 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.
In Subpart B (patient safety), we are proposing 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 patient safety
requirements incorporate current CDC infection control procedures,
retain and update our incorporation by reference of the AAMI standards
and guidelines for water quality and dialyzer reuse practices, and
incorporate by reference applicable current Life Safety Code (LSC)
provisions.
Subpart C (patient care) includes: (1) Requirements that emphasize
a dialysis facility's fundamental responsibility to respect and promote
the rights of each patient (patient rights); (2) the critical nature of
a comprehensive assessment in determining appropriate treatments and
achieving desired health outcomes (patient assessment); (3) the
interdisciplinary team approach of providing dialysis services to
patients and the process by which the interdisciplinary team will
achieve effective patient health outcomes (patient plan of care); (4)
the quality assessment and performance improvement program which would
charge each dialysis facility with the responsibility for carrying out
a performance improvement program of its own design to affect
continuing improvement in quality outcomes and patient satisfaction;
and (5) the consolidation of the various aspects of home dialysis care
into a single condition (care at home).
Subpart D (administration) covers 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).
We recognize that there are some who believe that regulations--
particularly those that directly affect the health and safety of
patients--should be very prescriptive in their detail to ensure that
providers do not engage in practices that threaten patient health and
safety. Therefore, we invite public comment on this fundamental shift
in our regulatory approach, especially in terms of: (1) How we could
improve on this approach; (2) what additional requirements could be
removed or added to provide greater flexibility; and (3) which existing
and new requirements are critical to patient care and safety.
E. Development of Outcome-Based Performance Quality Measures
Sections 1881(b)(5)(B) through (D) of the Act provide authority for
us to obtain the data we need from ESRD suppliers. In accordance with
these goals, we envision an information system that protects patients'
privacy in compliance with the new privacy protections afforded by the
Department's health information privacy regulations at 45 CFR Parts 160
and 164. These regulations were developed under the authority of the
Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The data could be accessed by us as well as dialysis patients, the
public, dialysis facilities, State survey agencies, ESRD networks,
researchers, policy makers, renal physicians, and other professionals
providing care to dialysis patients (where permitted by the privacy
regulations). This system would provide information to meet the needs
of the entire renal community, particularly the patients, to make
better choices about care, and to help dialysis providers identify
opportunities for continuous improvement in patient care processes.
This proposal is in keeping with our strategic plan to help
patients and the public become better informed about the health care
services they need and receive so they can make better health
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care choices and participate more fully in their care. The availability
of information will permit patients to become more active and effective
participants in their own care and in their facility's quality
improvement process.
1. Dialysis Facility Compare
One of the first steps to make information more available to the
public is the CMS Dialysis Facility Compare website at: http://www.Medicare.gov/Dialysis/Home.asp.
Dialysis Facility Compare contains
various dialysis facility characteristics and specific quality measures
including the percentage of in-center hemodialysis patients with a urea
reduction rate (URR) (a measure of the adequacy of dialysis) equal to
or greater than 65, the percentage of patients treated with Epogen who
have hematocrits of 33 percent or greater (reflecting adequately
managed anemia), and patient data categories on every dialysis facility
approved to participate in the Medicare program.
2. Dialysis Facility Data Reporting Requirements
Sections 1881(b)(5)(B) through (D) of the Act require ESRD
suppliers to furnish all necessary information to CMS, the ESRD
networks, and State survey agencies. Moreover, existing regulations at
Sec. 405.2133 require that each ESRD facility furnish data and
information in a manner and frequency specified by the Secretary. This
proposed regulation would continue to require facilities to provide
data and other information, but in electronic format, including
clinical performance measures (CPM) data, necessary for the
administration of the ESRD program.
3. Facility Specific Reports
In 1996, CMS first distributed facility-specific reports to
Networks and facilities. These reports were compiled by the University
of Michigan, using data from the CMS forms used for patient eligibility
and patient death purposes; the CMS claims forms; the certification
forms; and facility-specific data on infection control practices
collected by the CDC.
The initial reports presented comparative data on patient
characteristics, patient outcomes, and facility practice patterns. A
common CMS database and common data formulations were used to create
these reports. Each year since 1996, these reports have been
distributed to ESRD Networks and ESRD facilities. The reports have
formed a basis for implementing and understanding quality improvement
activities. The data that form the basis for these facility-specific
reports are used to report patient outcomes and to develop additional
reports.
CMS has expanded the Facility Specific Reports to include a broader
array of information, including facility-specific reports for the use
of State survey agencies, state-specific reports, and region-specific
reports. The facility-specific reports have been improved by the
expansion of facility practice pattern information, explanatory text
with each report, table and graph modifications, and the inclusion of
additional risk-adjusters in the calculations of the standardized
mortality ratio.
4. The National Kidney Foundation Kidney Disease Outcomes Quality
Initiative (NKF-K/DOQI) Clinical Practice Guidelines
In March 1995, the National Kidney Foundation (NKF) initiated the
National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-
DOQI), the first comprehensive effort in nephrology designed to provide
evidence-based guidance to clinical care in nephrology. Development of
the NKF-DOQI clinical practice guidelines involved a 2-year effort in
which independent interdisciplinary workgroups reviewed the available
body of scientific literature on hemodialysis and peritoneal dialysis
adequacy, vascular access, and anemia. Each workgroup was composed of
renal experts from diverse clinical disciplines and renal patients. The
workgroups were tasked with developing and promulgating clinical
practice guidelines for the treatments of patients with ESRD. Four
principles guided the project's decision-making: (1) Use of a high
level of scientific and methodological rigor in the guideline
development process; (2) commitment to an interdisciplinary approach;
(3) independence of the workgroups; and (4) openness of the guideline
development process. To that end, the workgroups developed draft
guidelines with supporting rationales that included the evidentiary
basis for the recommendations.
Draft guidelines were subject to an unprecedented three-stage
review process: (1) An advisory council, comprised of 25 experts,
provided comments on the initial draft of the guidelines; (2) a variety
of organizations (that is, ESRD networks, professional and patient
associations, dialysis providers, government agencies, product
manufacturers, and managed care groups) were invited by NKF to review
and comment on a revised draft of the guidelines; and (3) a final draft
of the guidelines was made available for public review by all
interested individuals or parties.
Four sets of DOQI clinical practice guidelines were published by
the NKF in 1997, including recommended practices for management of
anemia, adequacy of hemodialysis, adequacy of peritoneal dialysis, and
vascular access. In 2000, the scope of DOQI expanded to encompass the
spectrum of chronic kidney disease prior to the need for dialysis
services. To reflect this expansion, DOQI became K/DOQI. A total of 114
chronic kidney disease clinical practice guidelines were developed by
the workgroups and reviewed by numerous professionals and patients. The
NKF has published Bone Metabolism and Disease in Chronic Kidney Disease
clinical practice guidelines and Hypertension and Antihypertensive
Agents in Chronic Kidney Disease as well as Managing Dyslipidemias
guidelines. The latest set of clinical practice guidelines being
developed under the K/DOQI umbrella are the CPGs for Cardiovascular
Disease in Dialysis patients.
5. CMS ESRD Clinical Performance Measures Project
In 1999, we merged our ongoing ESRD Core Indicators Project, a
quality improvement project, originally started in 1994, into a new
ESRD Clinical Performance Measures Project (ESRD CPM Project). The ESRD
CPM Project is an ongoing effort between us, the ESRD networks, and
dialysis facilities to collect performance measures on a representative
sample of dialysis patients in the areas of adequacy of dialysis,
anemia management, nutrition (that is, serum albumin), and more
recently, vascular access (DHHS/CMS/CBC, pp. 1-104). The ESRD CPM
Project was developed to implement section 4558(b) of the Balanced
Budget Act (BBA) of 1997 (Pub. L. 105-33). This provision required the
Secretary to develop and implement a method to measure and report on
the quality of renal dialysis services provided under Medicare no later
than January 1, 2000.
The goal of the CPM Project was to identify NKF DOQI guidelines
that were suitable for the agency's quality improvement initiatives and
to meet the BBA requirement. The ultimate purpose of the project is to
assist suppliers of ESRD services in improving the care provided to
ESRD patients.
In 1998, we contracted with PRO-West (now named Qualis Health), a
Seattle-based private nonprofit healthcare quality improvement
organization, to facilitate the process of developing dialysis clinical
[[Page 6189]]
performance measures (CPMs) based on the NKF's DOQI (now K/DOQI)
guidelines.
The process included several components. The first was to develop a
mechanism to assure appropriate participation from the community in
order to facilitate the acceptability and utility of the CPMs. The
second was to prioritize the NKF DOQI guidelines based on the strength
of the evidence supporting the guidelines, the feasibility of
developing performance measures, and the significance of the areas
addressed to the quality of care delivered to dialysis patients. The
third was to identify a limited set of CPMs that could be used to
support quality improvement activities as well as assist us in
assessing nationally the quality of care delivered to Medicare
beneficiaries. The fourth was to develop sampling and data
specifications for the CPMs to facilitate measurement. Finally, we
requested the development of data collection and analysis strategies to
be used to augment the existing national performance measurement
system.
The CPM Project was conducted in collaboration with a broad range
of stakeholders in the community. In order to facilitate this
involvement, participation was solicited through contacts with
professional and voluntary associations, presentations at national
meetings, and invitations to individuals identified through a variety
of sources.
Four expert groups were convened to address each of the topic areas
covered by the NKF DOQI guidelines: (1) Hemodialysis adequacy; (2)
peritoneal dialysis adequacy; (3) vascular access; and (4) anemia
management. The NKF DOQI guidelines were ranked via a survey of renal
experts for their suitability as candidates for development of CPMs.
All 114 NKF DOQI guidelines were included on a survey tool developed by
CMS that was distributed to the rapid response group (RRG) and other
expert consultants. Suitability of guidelines was based on clinical
importance, feasibility of measurement, and the respondent's assessment
of the strength of the evidence supporting the guideline.
We accepted 36 proposed guidelines for further evaluation and the 4
expert groups developed specific review criteria, algorithms, and CPMs
selected through the prioritization process described above. The CPM
development process was a modification of a methodology described by
the Agency for Healthcare Research and Quality (AHRQ) (formerly the
Agency for Health Care Policy and Research (AHCPR)). Candidate
guidelines that did not have a strong evidence basis were eliminated
from further consideration. Sixteen CPMs were developed based on 22 of
36 candidate NKF DOQI clinical practice guidelines.
Data collection instruments were subsequently developed and
submitted to us for field testing. Three data collection tools were
developed and pilot tested. The first instrument was intended to
collect data for the hemodialysis adequacy, anemia management, and
vascular access CPMs from hemodialysis patient records. The second
instrument was designed to collect adequacy and anemia management data
for peritoneal dialysis patients. The third instrument focused on
information about facility policies, procedures, and practices related
to selected hemodialysis adequacy CPMs. In the summer of 1999, after
field-testing, the CPMs were applied to a sample of 8,853 randomly
selected adult hemodialysis patients and 1,650 randomly selected adult
peritoneal dialysis patients.
In summary, the NKF DOQI process resulted in a broad set of
guidelines amenable to prioritization based on strength of evidence,
clinical importance and feasibility. The current NKF K/DOQI guidelines
are widely accepted among the renal community and increase the
likelihood that future CPMs can be developed and supported by a broad
cross-section of stakeholders, including clinical practitioners,
industry representatives, professional associations, and others
interested in assessment and improvement of the care provided to
dialysis patients.
We have been working closely with the ESRD networks and information
technology contractors to develop the Vital Information System to
Improve Outcomes in Nephrology (VISION) database. VISION is a patient-
specific, facility-based, outcome-oriented information system that will
enable dialysis facilities to electronically collect and report both
demographic and clinical data that can be profiled to assist efforts to
improve outcomes of care. VISION will capture, among other things, data
from the CMS ESRD CPM Project. VISION will be designed so that
Consolidated Health Informatics (CHI) standards will be met.
The CHI establishes health messaging and vocabulary standards that
enable data sharing across all Federal systems. Implementation of the
CHI standards is prospective (that is, applicable to new systems and
systems undergoing major upgrades). Current plans are to upgrade the
ESRD Information System within the next 2 to 3 years. Since the CHI
standards are prospectively applied, the CHI standards will be
incorporated when we upgrade the ESRD information system.
Following the upgrade to the ESRD information system, ESRD
facilities will be required to submit data using the new information
technology (IT) system. They can accomplish submission of data that is
consistent with the CHI standards by either modifying their internal
systems or by using mapping tools that are provided by the National
Library of Medicine (NLM) at no cost. The CHI standards are posted on
the egov.gov Web site located at http://www.whitehouse.gov/omb/egov/gtob/health_informatics.htm
.
6. CPM Data Reporting
ESRD CPM Project data have been collected for 1999, 2000, 2001, and
2002 and published in annual reports. The 2001 ESRD CPM report can be
found on the Internet at http://www.cms.gov/esrd/l.asp. The data for
each year include a random sample, stratified by ESRD network, of adult
in-center hemodialysis patients and a random peritoneal dialysis
patient sample of 5 percent of adult peritoneal dialysis patients in
the nation. The sample size of adult in-center hemodialysis patients
was selected to allow us to be 95 percent confident that Network-
specific estimates for selected clinical measures are accurate within
plus or minus 5 percent. The sample also included a 30 percent ``over
sample'' for in-center hemodialysis patients and a 10 percent ``over
sample'' for peritoneal dialysis patients to compensate for anticipated
nonresponse rates. In 2002, the in-center hemodialysis sample included
8,863 patients and the peritoneal dialysis sample included 1,451
patients. Also, a 5 percent national sample of hemodialysis facilities
was drawn, consisting over 200 hemodialysis facilities.
Three data collection tools were used, an in-center hemodialysis
form (Form CMS-820), a peritoneal dialysis form (Form CMS-821), and a
hemodialysis facility-specific form.
We believe that the ESRD CPM Project is an effective tool to
facilitate ESRD quality improvement, and this project has successfully
tracked positive improvements in patient outcomes of care in several
areas. The 2001 Annual Report for the ESRD CPM Project contains
additional Outcomes Comparison Tools (for hemodialysis and peritoneal
dialysis). Outcomes Comparison Tools are practical quality improvement
instruments that can be used by ESRD facilities to benchmark their
performance outcomes against rates at the ESRD network's level
[[Page 6190]]
(hemodialysis only) and the nation. Therefore, we are proposing in the
Governance condition for coverage (Sec. 494.180(h)), that all ESRD
facilities collect and provide us with ESRD CPM Project data
electronically. This proposal applies only to the current CPMs and is
discussed in more detail later in this preamble. We will carefully
evaluate any revisions to the CPMs as well as any future CPMs,
developed in accordance with the National Technology Transfer and
Advancement Act of 1995 process (described in the next section of this
preamble) for possible inclusion as electronic reporting requirements.
The Secretary will provide notice and an opportunity for comment in the
Federal Register before the CPMs are updated or new measures are
adopted.
7. Updating Existing ESRD Patient-Specific Performance Measures and
Developing Future ESRD Facility Performance Standards
We would like to propose ESRD performance standards that dialysis
facilities would be required to meet as well as propose a method to
recognize updates in existing consensus-based patient-specific
performance measures. We are proposing to adopt a framework that will
utilize existing Federal legislation and operational guidelines. The
National Technology Transfer and Advancement Act of 1995 ((NTTAA) Pub.
L. 104-113) and OMB Circular A-119 specify circumstances in which
Federal agencies should use technical standards developed by voluntary
consensus bodies. The phrase ``technical standards'' is defined in the
NTTAA at section 12(d)(4) as ``performance-based or design-specific
technical specifications and related management systems practices.''
The NTTAA has been implemented by, among other things, the
provisions of the Office of Management and Budget (OMB) Circular No. A-
119 (63 FR 8546, February 19, 1998). OMB Circular No. A-119 was
published to: (1) Revise and clarify policies on Federal use and
development of voluntary consensus standards; (2) set policy for
conformity assessment activities; and (3) improve the clarity and
effectiveness of the previously published (October 20, 1993) circular.
By implementing the policies in this circular, we intend to reduce to a
minimum our reliance on government-specific standards.
Definitions of terms and phrases within the circular are designed
for very broad application, but are meant to be applicable to any
specific and appropriate subject matter, including health care
performance measures.
The circular defines a ``performance standard'' as a standard that
states requirements in terms of required results with criteria for
verifying compliance but without stating the methods for achieving
required results. ``Voluntary consensus standards'' are defined as
standards developed or adopted by voluntary consensus standards bodies,
both domestic and international. ``Voluntary consensus standards
bodies'' are organizations that plan, develop, establish, or coordinate
voluntary consensus standards using agreed-upon procedures. One example
of a voluntary consensus standards body is the National Forum for
Health Care Quality Measurement and Reporting, also known as the
National Quality Forum (NQF), which is currently engaged in various
projects such as standardizing measures of hospital quality and
developing diabetes mellitus treatment performance measures.
The expected products of a voluntary consensus body would include
the measures or indicators and standards, as well as explanatory text
and other supporting documentation, such as guidelines for reporting
the indicators. A voluntary consensus body would make a draft product
available for general public review during the development of the
measures. When the performance standards are complete, we would
evaluate them and then promulgate the standards following the
requirements of the Administrative Procedures Act.
We are not advocating the NQF as the voluntary consensus body that
is most appropriate to develop ESRD performance standards. We have only
provided an illustration of the manner in which performance standards
are being developed. Other organizations, for example, the NKF-K/DOQI,
also function in a manner consistent with voluntary consensus bodies.
Once ESRD facility performance measures are developed by a voluntary
consensus body, the Secretary would evaluate those facility performance
measures and adopt those that meet our needs for the effective
administration of the ESRD program after notice and comment rulemaking
required by the Administrative Procedures Act.
We will also reference the NTTAA later in this preamble under our
discussion of the Governance condition for coverage (see Sec.
494.180(h)).
F. Summary of the Contents of the Proposed Rule
We are proposing to revise both the content and the organization of
the existing regulations. The ESRD Network conditions for coverage will
remain in part 405, subpart U. Through a separate proposed rule
regarding conditions of participation for transplant hospitals, we are
proposing to move the renal transplant center conditions to part 482.
The ESRD conditions for coverage (health and safety provisions for
dialysis facilities) would be moved from existing 42 CFR part 405,
subpart U, to a new 42 CFR part 494, where they would 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 to Sec. 488.604 through Sec. 488.610. Since many of the
existing ESRD conditions would be revised, consolidated with other
conditions, or deleted, we also propose to completely renumber and
reorganize the requirements. The format for the dialysis facility
conditions for coverage represents a dramatic change from the
organization of the existing regulations, which contain nearly 20
conditions addressing organizational structure, utilization rate
requirements, and other process-intensive requirements. The proposed
regulations are divided into four subparts: general provisions, patient
safety, patient care, and administration.
The proposed organization of Part 494 is as follows:
Subpart A--General Provisions
Sec. 494.1 Basis and scope.
Sec. 494.10 Definitions.
Sec. 494.20 Compliance with Federal, State, and local laws and
regulations.
Subpart B--Patient Safety
Sec. 494.30 Condition: Infection control.
Sec. 494.40 Condition: Water quality.
Sec. 494.50 Condition: Reuse of hemodialyzers and other dialysis
supplies.
Sec. 494.60 Condition: Physical environment.
Subpart C--Patient Care
Sec. 494.70 Condition: Patient rights.
Sec. 494.80 Condition: Patient assessment.
Sec. 494.90 Condition: Patient plan of care.
Sec. 494.100 Condition: Care at home.
Sec. 494.110 Condition: Quality assessment and performance
improvement.
Sec. 494.120 Condition: Special purpose renal dialysis facilities.
Sec. 494.130 Condition: Laboratory services.
Subpart D--Administration
Sec. 494.140 Condition: Personnel qualifications.
Sec. 494.150 Condition: Responsibilities of the medical director.
Sec. 494.160 Condition: Relationship with ESRD network.
[[Page 6191]]
Sec. 494.170 Condition: Medical recordkeeping.
Sec. 494.180 Condition: Governance.
The following provides a detailed discussion of each new
requirement and a discussion of the existing ESRD requirements that
have been revised or deleted in this proposed rule.
III. Provisions of Proposed Part 494 Subpart A (General Provisions)
A. Basis and Scope (Proposed Sec. 494.1)
[If you choose to comment on issues in this section please include the
caption ``Basis'' at the beginning of your comment.]
Proposed Sec. 494.1, identifies the statutory authority for the
regulations. Proposed Sec. 494.1 also states that provisions of part
494 serve as the basis for survey activities for determining whether a
dialysis facility meets the conditions for coverage under the Medicare
program. We note that the organizational format of the proposed
conditions permits the elimination of almost all of the material in
existing Sec. 405.2100, Scope of subpart, which consists largely of a
description of the contents of the existing ESRD conditions for
coverage.
B. Definitions (Proposed Sec. 494.10)
[If you choose to comment on issues in this section please include the
caption ``Definitions'' at the beginning of your comment.]
Under proposed Sec. 494.10, we set forth definitions for terms
used in the ESRD conditions. Existing Sec. 405.2102 provides a list of
32 definitions. We are proposing to eliminate the definitions of
several terms for which we believe the meaning is self-evident, as well
as terms that are not used in the revised conditions. We do not believe
it is appropriate to have substantive requirements contained in those
definitions. Thus, we would move definitions that contain qualification
requirements to the appropriate conditions in the proposed rule. We
have proposed to retain the definition of ``furnishes on the premises''
and add it to proposed Sec. 494.180 (Governance). We are proposing a
modification of the definition of ``home dialysis'' to recognize the
assisting role that a family member/caregiver may play. We have
previously received questions about whether the definition of ``home''
includes institutional settings such as nursing facilities (NFs) and
skilled nursing facilities (SNFs). Please refer to section V.D. of this
preamble in which we discuss the unique needs of the NF/SNF dialysis
patient and the overall issue. We are soliciting comment on whether the
definition of ``home'' for ``home dialysis'' should also include these
institutional settings.
We propose to include the following definitions in Sec. 494.10:
Dialysis facility means an entity that provides (1)
outpatient maintenance dialysis services; or (2) home dialysis training
and support services; or (3) both. A dialysis facility may be an
independent or hospital-based unit (as described in Sec. 413.174(b)
and (c) of this chapter), or a self-care dialysis unit, which furnishes
only self-dialysis services.
Discharge means the termination of patient care services
by a dialysis facility.
Furnishes directly means the ESRD facility provides the
service through its own staff and employees or through individuals who
are under contract with the facility to furnish these services
personally for the facility. We note that furnishes directly does not
apply to companies providing services under contract or arrangement.
Home dialysis means outpatient dialysis performed at home
by an ESRD patient (or caregiver) if the individual performing such
dialysis has completed the course of training required in Sec.
494.100(a) of this part.
Interdisciplinary team (as required in Sec. 494.80
(Patient assessment)) means the group of persons responsible for
providing patient care to each dialysis patient.
Self-dialysis means dialysis performed with little or no
professional assistance by an ESRD patient (or caregiver) if the
individual performing such dialysis has completed an appropriate course
of training as required in Sec. 494.100(a) (Care at Home).
Transfer means a temporary or permanent move of a patient
from one dialysis facility to another that requires the transmission of
the patient's medical record information to the facility receiving the
patient.
C. Compliance With Federal, State, and Local Laws and Regulations
(Proposed Sec. 494.20)
[If you choose to comment on issues in this section please include the
caption ``Compliance with Laws and Regulations'' at the beginning of
your comment.]
Existing Sec. 405.2135 requires that a dialysis facility be in
compliance with applicable Federal laws and that a dialysis facility be
licensed or approved as meeting applicable standards by the agency of
the State or locality responsible for approval. Section 405.2135
further requires a facility to comply with all relevant laws (for
example, laws relating to licensure of staff) and requires conformity
with other laws (for example, fire safety, equipment maintenance).
We propose to retain the requirement that dialysis facilities must
be in compliance with applicable Federal, State, and local laws and
regulations pertaining to fire safety, equipment, and any other
relevant health and safety issues. We are also proposing that dialysis
facilities must be in compliance with the appropriate Federal, State,
and local laws and regulations regarding drug and medical device usage.
An example of meeting applicable Federal regulations is that the
dialysis facility must use FDA-approved/cleared medical devices and
adhere to the devices' labelling instructions. We have added these
examples because drugs and medical devices are major components of
dialysis facilities and compliance with existing laws and regulations
in this area is important in ensuring patient safety.
We may find a facility to be in violation of these conditions for
coverage if the facility is found out of compliance with any Federal,
State, and local law or regulation pertaining to health and safety
requirements.
IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)
A. Infection Control (Proposed Sec. 494.30)
[If you choose to comment on issues in this section please include the
caption ``Infection Control'' at the beginning of your comment.]
Patients with ESRD have impaired immunological systems and are more
at risk of developing serious infections than similarly situated non-
ESRD patients. During hemodialysis therapy, there is a potential for
patients to be exposed to a variety of microbial pathogens (including
blood-borne pathogens) if proper procedures are not meticulously
followed. Likewise, peritoneal dialysis patients are at risk of
contamination leading to peritonitis if proper procedures are not
followed. This proposed rule stipulates that the dialysis facility must
provide and monitor conditions to ensure a sanitary environment that
prevents the transmission of infectious agents.
The existing standards relating to infection control are contained
in Sec. 405.2140(b)(1) and (c). Section 405.2140(b)(1) requires
written procedures for controlling hepatitis and other infections. It
further specifies that the procedures include surveillance and
reporting of infections, housekeeping, handling of waste and
contaminants, and sterilization and disinfection. Section 405.2140(c)
requires the facility
[[Page 6192]]
to employ appropriate techniques to prevent cross-contamination between
the unit and adjacent hospital or public areas.
We believe infection control is vital to the health and safety of
dialysis patients and others; and therefore, we propose to establish
infection control as a separate condition for coverage (Sec. 494.30).
The proposed infection control requirement states that each dialysis
facility must provide and monitor a sanitary environment that prevents
and controls the transmission of infectious agents, within and between
the unit and any adjacent hospital, or other public areas. The proposed
requirement sets forth the basic guidelines or procedures that
facilities must follow to prevent and control infections.
Proposed Sec. 494.30(a)(1) requires that the facility demonstrate
that it follows standard infection control precautions, including the
``Recommended Infection Control Practices for Hemodialysis Units At a
Glance'' with the exception of screening for Hepatitis C as explained
below. The ``At a Glance'' section is in the publication,
``Recommendations for Preventing Transmission of Infections Among
Chronic Hemodialysis Patients'' developed by the Centers for Disease
Control and Prevention (CDC) (DHHS/CDC, 20-21). We propose to
incorporate these guidelines to prevent and control cross contamination
and the spread of infectious agents. These CDC infection control
recommendations specific to the hemodialysis setting were developed in
consultation with other Federal agencies and specialists and are based
on available knowledge regarding transmission of infectious agents.
Recommended Infection Control Practices for Hemodialysis Units at a
Glance
Infection Control Precautions for All Patients
Wear disposable gloves when caring for the patient or
touching the patient's equipment at the dialysis station; remove gloves
and wash hands between each patient or station.
Items taken into the dialysis station should either be
disposed of, dedicated for use only on a single patient, or cleaned and
disinfected before taken to a common clean area or used on another
patient.
--Nondisposable items that cannot be cleaned and disinfected (e.g.,
adhesive tape, cloth covered blood pressure cuffs) should be dedicated
for use only on a single patient.
--Unused medications (including multiple dose vials containing
diluents) or supplies (syringes, alcohol swabs, etc.) taken to the
patient's station should be used only for that patient and should not
be returned to a common clean area or used on other patients.
When multiple dose medication vials are used (including
vials containing diluents), prepare individual patient doses in a clean
(centralized) area away from dialysis stations and deliver separately
to each patient. Do not carry multiple dose medication vials from
station to station.
Do not use common medication carts to deliver medications
to patients. Do not carry medication vials, syringes, alcohol swabs or
supplies in pockets. If trays are used to deliver medications to
individual patients, they must be cleaned between patients.
Clean areas should be clearly designated for the
preparation, handling and storage of medications and unused supplies
and equipment. Clean areas should be clearly separated from
contaminated areas where used supplies and equipment are handled. Do
not handle and store medications or clean supplies in the same or an
adjacent area to that where used equipment or blood samples are
handled.
Use external venous and arterial pressure transducer
filters/protectors for each patient treatment to prevent blood
contamination of the dialysis machines pressure monitors. Change
filters/protectors between each patient treatment, and do not reuse
them. Internal transducer filters do not need to be changed routinely
between patients.
Clean and disinfect the dialysis station (chairs, beds,
tables, machines, etc.) between patients.
--Give special attention to cleaning control panels on the dialysis
machines and other surfaces that are frequently touched and potentially
contaminated with patients' blood.
--Discard all fluid and clean and disinfect all surfaces and containers
associated with the prime waste (including buckets attached to the
machines).
For dialyzers and blood tubing that will be reprocessed,
cap dialyzer ports and clamp tubing. Place all used dialyzers and
tubing in leak-proof containers for transport from station to
reprocessing or disposal area.
Schedule for Routine Testing for Hepatitis B Virus (HBV) and Hepatitis C virus (HCV) Infections
----------------------------------------------------------------------------------------------------------------
Patient status On admission Monthly Semi-annual Annual
----------------------------------------------------------------------------------------------------------------
All patients HBsAg*, Anti-HBc (total)*
Anti-HBs*, Anti-HCV,
ALT[dagger]
----------------------------
HBV susceptible, including ........................... HBsAg
non-responders to vaccine
----------------------------
Anti-HBs positive(>10 mIU/ ........................... ................. ................. Anti-HBs
mL), anti-HBc negative
----------------------------
Anti-HBs and anti-HBc ........................... No additional HBV testing needed
positive
----------------------------
Anti-HCV negative ........................... ALT Anti-HCV
----------------------------------------------------------------------------------------------------------------
Hepatitis B Vaccination
Vaccinate all susceptible patients against hepatitis B.
Test for anti-HBs 1-2 months after last dose.
--If anti-HBs is < 10 mIU/mL, consider patient susceptible, revaccinate
with an additional three doses, and retest for anti-HBs.
--If anti-HBs is >10 mIU/mL, consider immune, and retest annually.
--Give booster dose of vaccine if anti-HBs declines to < 10 mIU/mL and
continue to retest annually.
Management of HBsAg-Positive Patients
Follow infection control practices for hemodialysis units
for all patients.
Dialyze HBsAg-positive patients in a separate room using
separate machines, equipment, instruments, and supplies.
[[Page 6193]]
Staff members caring for HBsAg-positive patients should
not care for HBV susceptible patients at the same time (e.g., during
the same shift or during patient change-over).
We are proposing an exception to the CDC recommendation for monthly
and semiannual screening for all hemodialysis patients for hepatitis C.
Patients with clinical indicators or risk factors for hepatitis C
should receive diagnostic testing as deemed necessary by the attending
physician. Medicare covers diagnostic testing for hepatitis C on a
case-by-case basis, but does not cover blanket hepatitis C screening at
this time. According to the CDC, transmission of hepatitis C can be
prevented by strict adherence to infection control precautions
recommended for all hemodialysis patients.
The ``At a Glance'' page highlights the crucial CDC recommendations
that serve as the minimum acceptable infection control practices. This
document reproduced above is currently available on the CDC Web site at
http: //http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm.
There is substantial evidence that the CDC guidelines work in
preventing the transmission of bloodborne infections. Recommendations
for the control of hepatitis B in hemodialysis centers were first
published in 1977 and within 3 years there was a sharp reduction in
incidence of hepatitis B infection among both patients and staff
members in hemodialysis centers (Alter, pp. 860-865).
The entire CDC RR05 report contains recommendations for infection
control precautions in greater detail than the ``At a Glance''
highlights. We considered proposing that the entire CDC RR05 document
be incorporated by reference. However, we want to be less prescriptive
and burdensome in our requirements while protecting patient safety.
Dialysis facilities are encouraged to utilize the more comprehensive
document when developing their infection control programs. For example,
the CDC infection control precautions for all patients identify
procedures for cleaning up a blood spill; and detail information on
glove use, protective gear, and handwashing. The CDC has issued
additional guidance regarding hand hygiene and environmental infection
control in the October 25, 2002 and June 6, 2003 issues of the
Morbidity and Mortality Weekly Report that dialysis facilities may want
to reference in their infection control policies (DHHS/CDC, pp.1-45 and
DHHS/CDC, pp. 1-44, respectively).
Existing Sec. 405.2140(b)(1) requires that written policies and
procedures must be in effect for preventing and controlling hepatitis
and other infections. There is no current requirement in the conditions
for coverage addressing patient isolation. However, many facilities
have adopted the 1977 CDC guidelines that recommend use of a separate
dialysis area, preferably a separate isolation room, for dialyzing
hepatitis B surface antigen positive patients. Newly opened
hemodialysis units would be required to have isolation rooms for
hepatitis B positive patients as described in the ``At a Glance''
section. For existing units in which a separate room is not possible,
there would be required to be a separate area removed from the
mainstream of activity that also allows for dedicated staff and
dedicated dialysis machines. When the facility determines that a
patient is infectious (from admission or at least annual testing) the
guidelines state that the facility would be required to isolate the
infected patient from susceptible patients to prevent the transmission
of the disease. We propose to require at Sec. 494.30(a)(2) that a
facility implement and maintain patient isolation procedures that
prevent and control the spread of infectious agents and communicable
diseases.
We also propose at Sec. 494.30(a)(3) that facilities implement
appropriate procedures for the handling, storage, and disposal of
waste, and for disinfection. Appropriate waste storage and disposal
procedures are important not only for the control of infections within
the units, but also for the welfare of the unit staff and the
community. Since local policies vary, we do not believe it is
appropriate to specify the minimum requirements for waste storage and
disposal. Rather, facilities should continue to operate in accordance
with applicable local laws and accepted public health procedures. We
also propose to require that facilities implement protocols for
cleaning and disinfection because we believe that adequate disinfection
of surfaces, medical devices, and equipment is an important part of a
facility's efforts to control and prevent cross-contamination. We
propose to add a requirement for the implementation and maintenance of
procedures regarding cleaning of surfaces and devices potentially
contaminated with blood to prevent patients from coming into contact
with a blood-borne pathogen. The CDC RR05 recommendations and dialysis
equipment manufacturers' instructions provide valuable information on
procedures a facility may adopt to meet this requirement.
We considered proposing to include 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. The AIA standards provide guidance to
facilities regarding unit design and parts of the guidance relate to
infection control. While we believe it is desirable for new units to
follow AIA standards, and many States have adopted these as minimum
standards, we recognize it may be overly burdensome to require existing
dialysis units to adhere to these standards.
We also considered including in the proposed rule the Healthcare
Infection Control Practices Advisory Committee's (HICPAC) guidelines
entitled ``Hand Hygiene in Healthcare Settings'' and ``Guideline for
Preventing Intravascular Device-Related Infections.'' We are inviting
comments on whether we should require new dialysis facilities to adhere
to AIA design standards or HICPAC guidelines.
We propose requirements for oversight of facility infection control
in Sec. 494.30(b). The facility must implement and monitor biohazard
and infection control policies and activities within the dialysis unit.
Any infection control policies adopted by the facility are only
effective when put into action. We propose that facilities must
designate a registered nurse as the infection control or safety officer
who maintains current infection control information, and reports to the
facility's chief executive officer or administrator and quality
improvement committee. The infection control nurse must maintain
current infection control information including the most current CDC
guidelines for the proper techniques in the use of vials and ampules
containing medication. For example, facilities should not pool vials of
any medications. An outbreak of serratia liquefacies from contamination
of erythropoietin at a hemodialysis center serves as a reminder of the
importance of the proper handling of medications in protecting the
dialysis patient. (Grohskopf, pp. 1491-1497.)
The infection control or safety officer is also responsible for
making recommendations regarding infection control training and
improvements. The designation of an infection control officer provides
a structure for infection control, encourages the maintenance of up-to-
date information, and increases accountability for infection control.
We propose to maintain the essence of the existing requirement for
surveillance and reporting of the incidence of
[[Page 6194]]
infection (Sec. 405.2140(b)(1)). The facility must analyze and
document the incidence of infections to identify trends and establish
baseline information on infection incidence as proposed in Sec.
494.30(c). By conducting a trend analysis of infections, the facility
will be able to identify opportunities for improvement to prevent or
eliminate the spread of infection or communicable disease between
patients. By tracking the number and types of infections, the facility
can identify areas that require improvement, indicate areas that have
improved, define measures to improve outcomes, review implementation of
improvement measures, and determine the success of the improvement
measures implemented.
In August 1999, the CDC initiated the CDC Dialysis Surveillance
Network (DSN), a voluntary national surveillance system monitoring
bloodstream and vascular infections by individual hemodialysis centers.
The purposes of the DSN are to provide a method for individual
hemodialysis centers to record and track rates of vascular access
infections, other bacterial infections, and intravenous antimicrobial
starts, and to provide rates for comparisons among various dialysis
centers. The infection control or safety officer should look toward the
CDC surveillance system as a resource. Information on the DSN may be
found on the following Web site: http://www.cdc.gov/ncidod/hip/Dialysis/dsn.htm
.
The existing standard governing infection control (Sec.
405.2140(b)(1)) contains a requirement governing reuse of dialyzers
which states that when dialysis supplies are reused, records are
maintained that can be used to determine whether established procedures
covering the rinsing, cleaning, disinfection, preparation, and storage
of reused items conform to the requirements for reuse. This standard is
redundant with the reuse requirements included in the AAMI guidelines
that are incorporated by reference in both the existing and proposed
regulations. Therefore, we are proposing to delete the requirement in
Sec. 405.2140(b).
Existing Sec. 405.2140(c) requires that written patient care
policies specify the functions of facility personnel and self-dialysis
patients with respect to contamination prevention. We are proposing to
delete the ``written policy'' requirement because it is process-
oriented and a paperwork burden.
As noted above, the existing conditions for coverage require
policies for surveillance and reporting of infections at Sec.
405.2140(b)(1). In this proposed rule, reporting requirements for
communicable diseases are listed at Sec. 494.30(d). The facility must
maintain a current list of the communicable diseases that must be
reported according to Federal, State, and local requirements, and have
a procedure for reporting these communicable diseases, which allows the
facility to accurately report incidences of communicable diseases.
These requirements are in concert with the present standard operating
practices in dialysis facilities.
B. Water Quality (Proposed Sec. 494.40)
[If you choose to comment on issues in this section please include the
caption ``Water Quality'' at the beginning of your comment.]
Water quality is of vital importance to a dialysis facility and to
the patient. Because we believe water quality is an essential health
and safety issue for ESRD patients, we are proposing a condition for
coverage for water quality in this proposed rule.
The hemodialysis patient's blood has the potential to be exposed to
toxic contaminants present in water. Some chemical contaminants are not
normally harmful when present in small amounts in usual physiological
fluids. However, since hemodialysis patients are exposed to the large
volume of water that is used to make dialysate, chemical contaminants
can be dangerous to them. If water supplies are biologically or
chemically contaminated, the patient may experience infection or other
adverse consequences. Limits on bacterial growth in water and dialysate
are necessary to prevent high bacterial counts associated with
pyrogenic reactions (fevers, chills, nausea).
The patient's exposure to contaminated water can be through water
mixed with dialysate, water mixed with reprocessing germicides, or
water used to flush out dialyzers. Contamination of the water system
with organic and inorganic chemicals, bacteria, and endotoxins can
result in adverse patient reactions, such as hemolysis, bacteremia,
pyrogenic reactions, or death. Exposure to some contaminants such as
aluminum can cause chronic health problems, while exposure to other
contaminants such as fluoride can be fatal. Therefore, a dialysis
facility must monitor the quality of the water used in treatments, as
well as monitor the equipment used in water treatment.
In the September 18, 1995 Federal Register (60 FR 48039), we
published a final rule that incorporated by reference the 1992 AAMI
standard for water quality and the AAMI recommended guidelines for
monitoring purity of water as published in the ``Hemodialysis
Systems,'' ANSI/AAMI RD5: 1992, sections 3.2.1, 3.2.2, and Appendix B,
sections B1-B5 (American National Standards Institute 1992). Each AAMI
standard or recommended practice reflects the collective expertise of a
committee of health care professionals and industrial representatives,
whose work has been reviewed nationally. AAMI standards and guidelines
undergo a regular 5-year review process that allows updates and
revisions. These consensus recommendations are intended to help ensure
patient safety.
The AAMI guidelines referenced in the existing conditions for
coverage have been replaced by more recent AAMI guidelines, and
therefore, we are proposing to incorporate new AAMI references. The
ANSI/AAMI RD5: 1992 document has been replaced by ``Concentrates for
Hemodialysis'' ANSI/AAMI RD61: 2000, ``Water Treatment Equipment for
Hemodialysis Applications'' ANSI/AAMI RD62: 2001, and ``Dialysate for
Hemodialysis'' ANSI/AAMI RD 52:2004. These publications update the
information on monitoring of water quality currently incorporated by
reference in Sec. 405.2140(a)(5) and provide additional recommended
practices.
We are proposing to incorporate by reference the following revised
AAMI water quality standards, published in ``Water Treatment Equipment
for Hemodialysis Applications,'' 4.2.1 and 5.2.1, Water Bacteriology;
4.2.2 and 5.2.2, Maximum Level of Chemical Contaminants; and 4.3, Water
Treatment Equipment requirements (American National Standards
Institute, 2001). The updated water purity standards, section 4.2.1,
now include bacteria and endotoxin action levels that identify the
concentration at which steps (such as system disinfection and
retesting) should be taken to reduce the levels to an acceptable range.
Facilities must take corrective action when these action levels are met
or exceeded.
The AAMI list of contaminants for which water must be tested has
been expanded to include antimony, beryllium, and thallium. These
chemicals were added based on changes in the United States
Environmental Protection Agency Safe Drinking Water Act 1996 (Pub. L.
104-182). AAMI's rationale for testing water for these contaminants may
be found in the appendix of the ANSI/AAMI RD62: 2001 document at
A.4.2.2 (American National Standards Institute, 2001).
We have also included the updated AAMI requirements for water
treatment equipment. This inclusion provides clarity by defining the
minimum
[[Page 6195]]
standards for water treatment equipment needed to protect patient
safety. Proper hemodialysis is dependent on the quality of the
dialysate. A water system consisting of the proper components and
maintained in accordance with the manufacturers' instructions, can be
expected to produce dialysate that meets the AAMI standards and
produces acceptable patient outcomes. The minimum safety requirements
are specified in the AAMI standards referenced in proposed Sec.
494.40(a)(1)(iii) for each component of the water treatment system
(that is, deionization, reverse osmosis, monitors, sediment filters,
carbon absorption media, automatically regenerated water softeners,
storage tanks, piping systems; and when used, ultrafilters, ultraviolet
irradiators, hot water disinfection systems, ozone disinfection
systems, and tempering valves). A water treatment system consisting of
the proper equipment components as identified by AAMI (and the Food and
Drug Administration (FDA)) is standard practice in dialysis facilities.
We are proposing state of the art water purity monitoring
guidelines outlined in ANSI/AAMI RD52: 2004 ``Dialysate for
Hemodialyzers'' section 7.2.1 document. Proposed Sec. 494.40(a)(2)
incorporates by reference the section that specifies the frequency of
water purity testing to insure meeting the AAMI limits specified in
Sec. 494.40(a)(1)(i) and (ii) as follows:
Bacteria and bacterial endotoxin levels of water must be
measured--
++ In established systems at least monthly;
++ In newly-installed systems at least weekly until an established
pattern of compliance can be demonstrated.
At least monthly in samples drawn from--
++ The first and last outlets of the water distribution loop;
++ Where water enters the dialyzer reprocessing equipment;
++ Outlet of the water storage tanks, if used;
++ Concentrate or from the bicarbonate concentrate mixing tank.
Bacteria levels must be measured at least monthly from a
sample of two or more dialysis machines, this sampling must ensure that
all machines are tested at least once a year.
Chemical analysis of water purity must be done at least
once a year and when--
++ The system is installed;
++ Membranes are replaced if using a reverse osmosis system;
++ Seasonal variations in source water suggest worsening water
quality; and
++ Reverse osmosis rejection rates, which are monitored daily using
continuous-reading monitors that measure product water conductivity,
fall below 90 percent.
Ultrapure dialysate has received attention in the clinical
literature and the working draft AAMI standards ``Dialysate for
Hemodialysis'' RD52 contains guidelines pertaining to ultrapure
dialysate. We are not proposing a requirement for ultrapure dialysate
at this time but we do invite comment on this topic. We also welcome
comment on the requirements for the frequency of water purity testing.
In addition, we are proposing further evidence-based requirements
consistent with AAMI guidelines within the proposed water quality
condition. The existing conditions for coverage do not address
requirements for the water treatment equipment, although the
interpretive guidelines for Sec. 405.2140(a)(5)(ii) do advise that
water treatment systems must include a carbon tank and either a reverse
osmosis or deionization system (DHHS/CMS, 1995). We are proposing that
the water treatment system must include a reverse osmosis or
deionization component that conforms to the referenced water treatment
equipment for hemodialysis applications AAMI guidelines 4.3.5 and
4.3.6. This is in keeping with current standards of practice, which are
widely adhered to by dialysis facilities. The reverse osmosis process
serves to remove dissolved salts, bacteria, viruses, pyrogens, and
organic molecules. Deionization serves to remove ions. A reverse
osmosis system along with pretreatment is used in the vast majority of
all dialysis centers and this requirement should not present an
additional burden to hemodialysis centers.
A consequence of patient exposure to high levels of chloramine via
dialysis is hemolytic anemia, which may be life-threatening. The 1992
AAMI guidelines specified at least once daily testing of purified water
for chlorine/chloramine levels. It is now widely recognized that
testing before each shift of hemodialysis sessions, which is the
current standard in many dialysis units, provides greater patient
safety. Therefore, we are proposing at Sec. 494.40(c)(2) to require
chlorine/chloramine testing of water samples that must be taken from
the exit port of the initial chlorine/chloramine removal component (or
carbon tank) prior to each patient shift or every 4 hours, whichever is
shorter, during operation of the water system, unless the facility
ensures on a daily basis that the source water is chlorine/chloramine
free by way of testing. In addition, proposed Sec. 494.40(c)(2)(i)
would require subsequent testing from the backup component (or second
carbon tank) if the test shows greater than 0.50 parts per million
(ppm) for free chlorine or 0.10 ppm for chloramine. Due to the dangers
of chlorine/chloramine exposure, each water purification system must
provide for the adequate removal of chlorine/chloramine and this is
standard operating practice in hemodialysis facilities. In conformity
with the referenced AAMI guidelines at 4.3.9, carbon tanks used for the
removal of chlorine/chloramine must contain granulated activated carbon
and provide adequate empty bed contact time to be effective. A backup
component or second carbon tank must be in place for failure of the
first line component for chlorine/chloramine removal (or first carbon
tank), in order to protect patients during a hemodialysis session.
Dialysis facilities would be required to follow the applicable FDA
recommendations in ``Guidance for the Content of Premarket
Notifications for Water Purification Components and Systems for
Hemodialysis'' that 2 carbon tanks be installed in series with empty
bed contact time of 10 minutes (DHHS/FDA, 1997). The second carbon tank
provides the backup safety measure. Some dialysis facilities have three
or four carbon tanks that provide even more assurance there will not be
chloramine breakthrough. We invite comment as to whether our proposed
conditions for coverage that include expanded water equipment
requirements are still too minimal. In addition, we are requesting
comments on whether the current AAMI guidance regarding carbon tanks is
adequate to address all potential health and safety problems associated
with chlorine, chloramines, and unannounced variations in source water.
Specifically, we seek comments regarding where there is sufficient
evidence to require Medicare-participating dialysis facilities to
maintain at least two carbon tanks (that is, primary and backup) as
part of their water treatment system, regardless of the current
composition of its source water.
We are proposing in Sec. 494.40(e) to require active surveillance
of hemodialysis patient reactions during and following dialysis,
particularly when there are adverse reactions that might be associated
with a problem with the water purification system. The facility must
take steps to protect patient safety and obtain the appropriate blood
and dialysate cultures. Evaluation of the water purification system
must be undertaken as well as any necessary corrective action (Sec.
494.40(d)).
[[Page 6196]]
If chlorine/chloramine levels in treated water from the last backup
component (or carbon tank) are above the AAMI standards as required in
proposed Sec. 494.40(a)(1)(ii), dialysis treatments must be
immediately stopped to protect patients from exposure to chlorine/
chloramine as proposed in Sec. 494.40(c)(2)(ii). The medical director,
who is ultimately responsible for water quality, must be notified
immediately and corrective action taken. A corrective action plan is
also required (see Sec. 494.40(d)) whenever any of the water purity
action levels or standards, including but not limited to, chemical,
microbial, and endotoxin, are detected.
We propose to add a requirement, consistent with in the AAMI
document RD52:2004, that specifies that once mixed, bicarbonate
concentrate must be used within the time specified by the manufacturer
of the concentrate and may not be mixed with fresh concentrate. The
holding of the bicarbonate concentrate presents the risk of bacterial
growth and should be avoided.
We considered addressing water quality for home dialysis patients
in this condition, but we decided instead to include a requirement that
the facility monitor water used by its home dialysis patients to ensure
that the water meets the AAMI standards under the proposed ``care at
home'' condition for coverage (Sec. 494.100). Addressing all home
dialysis issues under a single condition simplifies the organization of
the regulations and eliminates the need for readers to refer to
separate sections for the requirements for home dialysis services.
C. Reuse of Hemodialyzers and Bloodlines (Proposed Sec. 494.50)
Section 1881(f)(7) of the Act requires the Secretary to establish
protocols for reuse of hemodialyzers for those facilities that
voluntarily elect to reuse the filters. The Act further states that
dialysis facilities that fail to follow the reuse protocol will be
subject to denial of participation in the Medicare program and denial
of payment for dialysis treatment not furnished in compliance with the
reuse protocol.
In hemodialysis the patient's blood is cleansed of impurities when
it passes through the filter (hemodialyzer) of a hemodialysis machine.
There are various techniques that allow some of these filters to be
reused under certain conditions. Reuse involves cleaning, disinfecting,
and preparing such hemodialysis devices for subsequent use for the same
patient. Although the potential exists for adverse patient outcomes
from reuse, reprocessing and reuse of dialyzers are safe when proper
techniques are utilized.
The existing regulation at Sec. 405.2150 requires ESRD facilities
reusing hemodialyzers to meet the guidelines and standards adopted by
AAMI and issued in July 1993, as ``Reuse of Hemodialyzers'' (American
National Standards Institute, 1993). We are proposing to retain this
requirement in the proposed rule but to incorporate by reference the
newly revised version and associated amendment (ANSI/AAMI RD47: 2002
and ANSI/AAMI RD47: 2002/A1: 2003) which replaces the 1993 version.
This document received final AAMI approval on November 7, 2002.
Some in the renal community believe that we should not incorporate
the CDC guideline that prohibits reuse for hepatitis B patients. They
believe there is no documentation that reuse contributes to the spread
of hepatitis or that it negatively affects the patient with hepatitis.
In addition, they indicated that this prohibition is costly to
facilities because a new dialyzer must be used for each session.
Hepatitis B is a highly contagious and potentially damaging
illness, especially for a dialysis patient. Thus, the CDC has for many
years recommended extreme caution and isolation for those patients who
are Hepatitis B positive. Many physicians, nurses and other
professionals involved in the dialysis field have similarly supported
the position of extreme caution in treating the hepatitis B positive
patient. The 2001 CDC guidelines advise against the reprocessing of
dialyzers used for patients who have Hepatitis B because of the risk to
facility staff. The hepatitis virus is relatively stable in the
environment and has been shown to remain viable for several days on
surfaces (via blood spills). While there may be no appreciable evidence
to demonstrate that reuse would increase the spread of hepatitis B,
there is not conclusive evidence that reuse in this population is safe.
At this time we propose to maintain the CDC guidelines prohibiting
reuse for hepatitis B patients to minimize the incidence of this mode
of transmission.
We are also proposing at Sec. 494.50(b)(2) that the hemodialyzer
manufacturer recommendations be followed, or if an alternate method for
reprocessing hemodialyzers is used, that the facility have documented
evidence that the method is safe and effective. According to FDA
guidance, hemodialyzer labeling should reflect the clinical use of a
hemodialyzer, and whether it is intended for single or multiple usage
(DHHS/FDA, 1995). Only hemodialyzers and bloodlines labeled for
multiple use may be reused. In addition, manufacturers of reusable
hemodialyzers are required to provide adequate instructions for safe
and effective reuse in accordance with 21 CFR 801.5. If the facility
chooses to use an alternate method for reprocessing hemodialyzers there
must be sufficient scientific evidence that the method is safe and
effective. This flexibility is provided to allow for the use of newer
and improved technologies that are proven safe in scientific studies
which may become available in the future. The FDA approved label
recommendations for the proper use of the device must be adhered to by
dialysis facilities.
Existing Sec. 405.2150(a)(2) states that to prevent any risk of
dialyzer membrane leaks due to the combined action of different
chemical germicides, dialyzers are exposed to only one chemical
germicide during the reprocessing procedure. We have received informal
suggestions that we alter the current language because many facilities
use bleach as part of the reuse process to flush and clean blood
deposits before the actual germicide soaking process is initiated.
However, for purposes of reuse, we consider bleach to be a cleansing
agent, not a germicide. The requirement to discard dialyzers treated
with a different germicide does not apply to bleaching. Nonetheless,
since the language appears to be confusing to some, we are proposing to
clarify the provision in proposed Sec. 494.50(b)(3) by inserting the
phrase ``other than bleach.''
Some in the renal community and on the AAMI RD47 workgroup stated
that discarding dialyzers exposed to a second germicide was expensive
and unnecessary if air pressure leak test results indicated the
dialyzer was still effective. However, we are proposing to retain the
requirement in existing Sec. 405.2150 that if a dialyzer is exposed to
a second germicide it must be discarded because we are concerned that
exposure to different germicides may cause membrane leaks. While we
recognize that it may be considered wasteful by some to discard
dialyzers with test values that indicate they are still effective, we
believe this is a necessary safety measure. We do not have sufficient
evidence that clearly supports the safety of using multiple germicides
on hemodialyzers. We welcome comment on the issue of multiple germicide
use in reused hemodialyzers.
Existing Sec. 405.2150(a)(3) requires that facilities take
appropriate blood cultures at the time a patient has a febrile response
and discontinue reuse of
[[Page 6197]]
hemodialyzers in the case of pyrogenic reactions, bacteremia, or
unexplained reactions possibly associated with ineffective
reprocessing, until the entire reprocessing system is evaluated. We
have been advised that a single febrile response in one patient can be
the consequence of many different etiologies not related to reuse,
including an infected access, a current infection, or contamination of
the water purification system. Members of the renal community suggested
that a febrile reaction in a single patient is rarely attributed to
dialyzer reuse. Facilities do not believe it is necessary to terminate
reuse or order blood cultures when a febrile reaction occurs in only a
single patient. It was suggested that a facility need only respond
through aggressive evaluation of its water purification system,
dialysis concentrates, and reuse system when the surveillance of
febrile events reveals a cluster of febrile patients. Based on this
evaluation, the facility can make an appropriate clinical decision
concerning termination of reuse. As a result, we are proposing in Sec.
494.50(c) to revise the regulations to state that a facility need only
obtain blood and dialysate cultures and evaluate its reprocessing and
water purification systems in response to an adverse reaction when
clinically indicated. If the evaluation indicates that the facility
should discontinue reuse, we expect facilities to have established
contingency plans, suspend the reuse of hemodialyzers until the problem
has been corrected, and report the adverse outcomes to the FDA and
other agencies as required by Federal, State or local laws and
regulations.
Existing Sec. 405.2150(c) lists 4 requirements applicable to a
facility that reuses bloodlines. Facilities must: (1) Limit the reuse
of bloodlines to the same patient; (2) not reuse bloodlines labeled for
``single use only''; (3) reuse only bloodlines for which the
manufacturer's protocol for reuse has been accepted by the FDA in
accordance with the premarket notification (see section 510(k) of the
Food, Drug, and Cosmetic Act and 21 CFR 876.5860 of the regulations);
and (4) follow the FDA-accepted manufacturer's protocol for reuse of
that bloodline. We propose to maintain the first requirement to limit
the reuse of bloodlines to the same patient because the risk of
transmitting blood-borne pathogens is so high, and reusing for the same
patient limits the risk of cross-contamination. We also propose to
maintain the third and fourth requirements, that is, a facility may
reuse only bloodlines for which the manufacturer's protocol for reuse
has been accepted by the FDA; and that the facility must follow the
FDA-accepted manufacturer's protocol for reuse of the bloodline. With
these requirements, the facility must follow any specific instructions
listed by the FDA, as well as any guidelines by the manufacturer that
may not be discussed in the FDA regulations. We are proposing to delete
the second existing requirement that facilities not reuse bloodlines
labeled for ``single use only'' because it is redundant with the
existing third and fourth requirements. Since the FDA would not
recommend reuse on bloodlines labeled ``single use only,'' there is no
need to maintain the requirement.
D. Physical Environment (Proposed Sec. 494.60)
[If you choose to comment on issues in this section please include the
caption ``Physical Environment'' at the beginning of your comment.]
The existing physical environment condition (Sec. 405.2140)
stipulates that the physical environment in which dialysis services are
furnished afford a functional, sanitary, safe, and comfortable setting
for patients, staff, and the public. The existing regulation consists
of four separate standards concerning building and equipment, favorable
environment for patients, contamination prevention, and emergency
preparedness. We propose to refine the physical environment section to
include only those elements that relate directly to the physical
surroundings of the dialysis facility and to relocate the remaining
elements to other sections in the proposed rule that relate more
closely to those subject areas.
The existing building and equipment requirements in Sec.
405.2140(a), include fire safety procedures, equipment maintenance,
facility maintenance, and water treatment. Based on the experience and
suggestions of our surveyors, we propose to establish separate
standards for the building itself in proposed Sec. 494.60(a) and
equipment in proposed Sec. 494.60(b). We propose to maintain the
existing requirement (described in Sec. 405.2140(a)) that the building
in which dialysis services are furnished be constructed and maintained
to ensure the safety of patients, the staff, and the public. The
dialysis facility should be free from hazards that may bring harm to
the patients, the staff, and the public.
The existing language of Sec. 405.2140(a)(2) stipulates that all
electrical and other equipment used in the facility be maintained free
of defects that could present a potential hazard to patients or
personnel and that there is a planned program of preventive maintenance
of equipment used in dialysis and related procedures in the facility.
We propose at Sec. 494.60(b) to maintain the essence of this
requirement but to clarify that all equipment is maintained in
accordance with the manufacturer's recommendations. Based on their
experience with the equipment, we believe manufacturers have the most
knowledge about routine maintenance and recommended repair.
Existing Sec. 405.2140(b) requires each facility to maintain a
favorable environment for patients; and the facility must be maintained
and equipped to provide a functional, sanitary, and comfortable
environment with an adequate amount of well-lighted space for the
services provided. The existing language in this standard combines
several different concepts, including sanitary environment and
infection control, and we propose to address each subject in separate
sections of the regulation. As a result, we are proposing at Sec.
494.60(c) to include only those standards regarding the safety and
comfort of each patient.
Since the proposed conditions are outcome-oriented, we believe that
we do not need to specify all the process requirements that a facility
must meet to provide a dialysis environment in which the patient can
receive quality care. Each facility can develop its own strategies and
techniques as long as the space for treating each patient is sufficient
to provide needed care and services, prevent cross-contamination, and
accommodate medically needed emergency equipment and staff. Existing
Sec. 405.2140(b) also requires the facility to provide a well-lit
space. We propose to delete this requirement because it is too
subjective to be meaningful, and we believe this detail is better left
to the judgment of the facility staff.
We expect the dialysis facility to provide patients with a
comfortable environment. Existing Sec. 405.2140(b)(4) requires that
heating and ventilation systems be capable of maintaining adequate and
comfortable temperatures. We recognize that not all patients are
comfortable at the same temperature; and therefore, proposed Sec.
494.60(c)(2) specifies that the facility maintain a temperature that is
comfortable for the majority of patients. The dialysis facility must
make reasonable accommodations for patients who are not comfortable at
the temperature setting determined by the majority of patients. The
facility has the option of allowing patients to bring a blanket to
dialysis or providing freshly laundered blankets to the patients.
Infection control procedures must be
[[Page 6198]]
adhered to in either case. Often patients need a warm environment
because of lowered body temperature during the dialysis process, and
therefore, facilities should look to patients rather than staff to
ascertain comfortable building temperatures.
In the emergency preparedness standard (proposed Sec. 494.60(d)),
we have proposed requirements that we believe are fundamental for a
dialysis facility to prepare effectively for emergency situations.
These requirements include: (1) Procedures for medical and non-medical
emergencies; (2) staff and patient training; (3) facility emergency
equipment; and (4) periodic evaluation of emergency plans. Existing
Sec. 405.2140(d) requires the facility to have written policies and
procedures that specifically define the handling of emergencies that
may threaten the health and safety of patients. The existing
regulations also stipulate that facility staff should be trained for
any emergency or disaster, as part of their employment orientation.
We propose to clarify at Sec. 494.60(d) that each dialysis
facility must implement emergency preparedness procedures to manage
potential medical and nonmedical emergencies that are likely to
threaten the health or safety of facility patients, the staff, and the
public. These emergencies 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. The facility will need to identify which hazards are
most likely to effect their facility, evaluate how to minimize risks,
and plan how to best protect patients in the event of an emergency,
using an emergency management approach. We do not expect individual
facilities to develop emergency plans for natural disasters that
typically do not affect their geographic location. For example,
facilities located in the Southeast would not typically need to develop
emergency procedures for earthquakes. Facilities located in the central
plains States, on the other hand, would need to be prepared for
tornadoes. All facilities must plan for fire, care related emergencies,
equipment and power failures, and interruption of the water supply,
because these emergencies may occur regardless of a facility's
geographic location.
In addition to having emergency procedures, a facility will need to
plan ahead so that necessary information and tools are available to
staff and patients. For example, a facility would need to have current
patient telephone numbers, addresses, and transportation information
available before an emergency happens rather then scrambling to update
this kind of information during an emergency. As a resource in their
movement toward an emergency management approach, dialysis facilities
may want to use the ESRD facility emergency preparedness guidelines
available from the ESRD Networks.
We propose to maintain the existing requirement that a facility
train each staff member on the actions required for different medical
and nonmedical emergencies. The existing conditions for coverage
require that emergency preparedness procedures be reviewed and tested
at least annually and revised as necessary. Also, all personnel must be
knowledgeable and trained in their respective roles in emergency
situations. We are proposing that staff training must be evaluated at
least annually and that staff must demonstrate knowledge of emergency
procedures. This requirement is designed to ensure the safety and
security of both the patients and the staff. We propose also to require
that the facility provide periodic training to patients and staff.
Patients routinely treated in dialysis units are at risk for medical
emergencies. As a result, standard medical practice dictates that the
facility must have trained personnel, drugs, and emergency equipment
available to adequately support patients until an Emergency Medical
System (EMS) unit responds to the facility.
We are proposing at Sec. 494.60(d)(1)(ii) that staff must maintain
current cardiopulmonary resuscitation (CPR) certification. This is the
standard practice in United States dialysis facilities. We have not
prescribed the type or number of staff who must maintain CPR
certification but at a minimum, the patient care staff must maintain
current CPR certification. In this instance, patient care staff are
staff who routinely provide direct medical care to patients in the
dialysis unit.
We would maintain the standard in the existing regulation (Sec.
405.2140(d)(5)) that the facility provides appropriate training to
patients, so that they know the facility's emergency procedures, since
they may need to take steps to protect themselves during an emergency.
Dialysis patients need to be informed on what to do, where to go, whom
to contact from home, and how to disconnect themselves from dialysis
equipment if an emergency occurs.
The existing text in Sec. 405.2140(d)(3) requires that the
facility have available at all times on the premises a fully equipped
emergency tray, including emergency drugs, medical supplies, and
equipment. We propose to maintain this requirement, but we want to
eliminate the confusion regarding the meaning of ``fully equipped.'' We
propose to define the minimum emergency equipment that must be on the
premises and immediately available as ``oxygen, airways, suction,
artificial resuscitator ventilation bag, defibrillator, and emergency
drugs.'' We propose to specifically require defibrillators. Automated
external defibrillators (AEDs), in particular, have been shown to save
lives in a variety of settings, most notably aboard airlines and in
airports. One Seattle study (Arch Intern Med. 2001;161:1509-1512
available at http://www.ARCHINTERNMED.com) identified dialysis centers
as having a relatively high incidence of cardiac arrest (>= 0.746 per
practice annually). In the 9 dialysis facilities studied there were 47
cardiac arrests over a 7-year period. Approximately 56 percent, or 26
patients, had ventricular fibrillation and may have benefited from use
of an AED. The authors of this study presented their findings to the
nine dialysis centers and all nine agreed to equip their centers with
AEDs and to train their staff in the use of AEDs.
The key to saving a life is getting the defibrillator on the
patient as soon as possible. The AED allows dialysis facility staff to
defibrillate a patient without requiring the immediate presence of a
physician. According to the American College of Emergency Physicians
(http://www.acep.org/1,2891,0.html), when a person suffers a sudden cardiac
arrest, the chance of survival decreases by 7 to 10 percent for each
minute that passes without defibrillation. The very real potential for
saved lives supports the financial investment in an AED. The cost of an
AED is approximately $2,000 to $3,000. Some units have already
voluntarily purchased AEDs. Very small units (for example, units with
two hemodialysis stations) may find the purchase of an AED to be a
heavy financial burden. We are soliciting comments on whether small,
predominantly rural dialysis facilities should receive special
consideration and possibly an exemption from the defibrillator
requirement. We propose that the dialysis nursing staff must be trained
on the proper use of emergency equipment and emergency drugs. Staff
could be trained on the use of an AED in conjunction with the CPR
training. Having the right equipment at the time of an emergency is
only useful when staff is well versed in how to effectively use it. In
addition, the facility must have
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a plan to obtain EMS assistance when needed.
We are proposing to require a defibrillator without specifying an
AED due to the fact that some dialysis units already have access to a
defibrillator. Hospital-based dialysis units, in particular, may have
immediate physician availability built into the hospital-wide cardiac
resuscitation plan. This reduces the financial burden of the proposed
defibrillator requirement.
We are proposing to maintain the requirement that facilities
conduct reviews of their emergency and disaster plans to ensure that
facilities appropriately respond to the situations and needs that may
arise from a variety of emergencies, medical and nonmedical. We are
proposing in Sec. 494.60(d)(3)(ii) that facilities review their
emergency and disaster plans at least annually. Drill and emergency
episodes often reveal a weakness or flaw in the design of the emergency
plan. An annual update will allow such flaws or potential problems to
be identified and corrected.
Existing Sec. 405.2140(b)(3) specifies that the facility have a
nursing/monitoring station from which adequate surveillance of patients
receiving dialysis services can be made. We propose to delete this
requirement because we believe this is not a physical environment
issue. It is important that patients are appropriately monitored during
the dialysis session. However, monitoring is most effectively done
through interaction between the patients and the staff in the dialysis
area and not from a monitoring station.
We believe that existing Sec. 405.2140(b)(5) is another process-
oriented requirement, and we propose to delete this requirement. This
requirement states that facilities using central batch processing must
make arrangements to meet the needs of patients with special dialysis
solutions. The Patient plan of care condition, proposed Sec. 494.90,
would require the dialysis facility to implement the care plan and make
arrangements to meet the individual requirements of each patient
regardless of whether those needs are related to special dialysis
solutions or other medically necessary supplies or equipment.
The existing emergency preparedness standard (Sec. 405.2140(d))
enumerates the facility physical emergency management procedures but
provides minimal standards for the procedures that must be followed
during a fire. We propose to strengthen the section governing fire
safety to provide greater detail regarding the appropriate procedures
that must be followed.
We are proposing at Sec. 494.60(e) to adopt the 2000 edition of
the National Fire Protection Association's (NFPA) Life Safety Code
(LSC). The LSC is a compilation of fire safety requirements for new and
existing buildings and is updated and published every 3 years by the
NPFA, a private, non-profit organization dedicated to reducing loss of
life due to fire.
The Medicare and Medicaid conditions of participation have
historically incorporated by reference these requirements along with
Secretarial waiver authority. The statutory basis for incorporating
NFPA's LSC for ESRD facilities falls under the Secretary's general
rulemaking authority.
The 2000 edition of the LSC is divided into several occupancy
chapters including a business chapter, educational chapters, ambulatory
health care occupancy chapters, and health care occupancy chapters. The
business occupancy chapter pertains to clinics and offices. The
educational occupancy chapters pertain to schools and day care centers.
The health care occupancy chapters pertain to inpatient health care
facilities (for example, hospitals, nursing homes). Finally, the
ambulatory health care occupancy chapters pertain to facilities that
provide outpatient medical treatment that may render the patient
temporarily incapable of self-preservation (for example, critical
access hospitals, dialysis centers).
The NFPA LSC Handbook specifically designates Chapter 20 and
Chapter 21 for outpatient dialysis services. We propose to adopt, as
recommended by the NFPA LSC, Chapter 20 (that is, new ambulatory health
care occupancy buildings) and Chapter 21 (that is, existing ambulatory
health care occupancy buildings) of the 2000 edition of the LSC for all
outpatient dialysis facilities regardless of size.
The LSC classifies dialysis facilities as ambulatory health care
occupancies because the treatment is not a routine medical visit to a
doctor's office but rather a procedure that may hinder the patient from
self-preservation in the event of an emergency or fire. Incapability of
self-preservation might be the result of the use of general anesthesia
or a treatment such as dialysis. Dialysis patients are not as mobile as
a person working or visiting an office building or health clinic but
more mobile than patients being treated in an inpatient health care
facility, such as a hospital or nursing home. Chapters 20 and 21 give a
level of safety from fire that is greater than the typical business
occupancy but less than a health care occupancy such as a hospital or
nursing home.
Under our proposal, an outpatient dialysis facility would comply
with the business occupancy provisions in Chapters 38 (that is, the new
business occupancies) and 39 (that is, existing business occupancies)
with the additional provisions contained within Chapters 20 and 21.
Where there may be a conflict between the business occupancy chapter
and the ambulatory health care occupancy chapter, the more stringent
requirements would apply (LSC sections 20.1.1.1.2 and 21.1.1.1.2). The
requirements of Chapters 20 and 21 are described below.
Chapter 20.1.2.1 and Chapter 21.1.2.1 require 1-hour fire
separation between different occupancies or tenants in a multi-tenant
building. We believe most dialysis facilities currently meet this
requirement because most State building codes already require this
provision.
Chapters 20.2.4 and 21.2.4 require that there be at least two
emergency exits. Emergency lighting is required by Chapters 20.2.9.1
and 21.2.9.1 to ensure that the center is lighted and that egress paths
are illuminated to allow movement during an emergency.
Chapters 20.2.9.2 and 21.2.9.2 require an essential electrical
system. This provision does not apply to dialysis facilities because
dialysis equipment is not life-support equipment under the Life Safety
Code.
Chapters 20.3.4.4 and 21.3.4.4 require the fire alarm system to
provide automatic notification of a fire to emergency forces. This is
of great importance for the protection of patients. Any delay in the
notification of fire and rescue personnel could adversely impact the
health and safety of patients and expose them to a fire, smoke, or
toxic gases created by the fire.
Chapters 20.3.7 and 21.3.7 pertain to smoke compartmentation,
otherwise known as subdivision of building space. Section 3.7 of
Chapters 20 and 21 apply to any dialysis facility that is larger than
5,000 square feet (or 10,000 square feet for facilities with
sprinklers). We believe most dialysis facilities will fall within the
exceptions outlined in this provision. If a dialysis facility is
smaller that 5,000 square feet and protected by an approved, supervised
sprinkler system, then section 3.7 of Chapters 20 and 21 do not apply.
Section 7 of Chapters 20 and 21 specify procedures to assist
outpatient dialysis facilities in providing fire safety. Section 7.1 of
Chapters 20 and 21 propose evacuation plans and fire exit drills and
require staff to practice the
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procedures outlined in the dialysis facilities written emergency plans.
Section 7.1 of Chapters 20 and 21 are appropriate for outpatient
dialysis facilities because there is a possibility a dialysis patient
could lose blood or suffer unnecessary risks if the patient were
removed from the dialysis machine during a fire drill. We believe that
requiring a dialysis facility to stop dialysis treatment and evacuate
all dialysis patients during a fire drill is an unnecessary procedure
that could jeopardize the dialysis patient's health and safety. Annex
A, Explanatory Material to the 2000 NFPA LSC provides guidance for
conducting fire drills when it is inexpedient and impractical to move
patients during a fire drill. Many health care occupancies conduct fire
drills by choosing the location of the simulated emergency in advance;
practicing the movement of simulated patients or empty wheelchairs to
adjacent safe areas, and ensuring that staff have the efficiency,
knowledge, and response capability to implement the facility's fire
emergency plan. Surveyors may determine whether this standard was met
by checking a dialysis facility's records and interviewing staff to
verify that the emergency and fire drills were conducted not less than
once in each 3-month period and that staff are very familiar with the
procedures.
Section 7.1.1 in Chapters 20 and 21 also require that the dialysis
facility prominently post its emergency plan. We expect the plan to
include continuity of essential building operations in the event of an
emergency. Electrical, water, fire protection, ventilation, and
communications systems are some, but not all, areas a dialysis facility
should consider in its disaster plan. A good reference, but not a
requirement for developing an emergency plan for a dialysis facility,
is the NFPA 99--Standard for Health Care Facilities, Chapter 11, Health
Care Emergency Preparedness (NFPA, November 2001). Our intent in
proposing the posting requirement is to ensure patients, staff and the
public have the proper information to quickly evacuate in the event of
an emergency.
The remaining provisions in section 7 of Chapters 20 and 21 include
requirements for the procedures in case of fire (20.7.2 and 21.7.2);
maintenance of exits (20.7.3 and 21.7.3); smoking regulations (20.7.4
and 21.7.4); furnishings, beddings, decorations (20.7.5 and 21.7.5);
maintenance and testing of life safety-related equipment (20.7.6 and
21.7.6); portable space heating devices (20.7.7 and 21.7.7); and
construction, repair and improvement operation (20.7.9 and 21.7.9).
We recognize that for some dialysis facilities it would be
extremely burdensome to adhere strictly to all of the LSC requirements.
For example, older dialysis facilities or facilities leasing space in
an office building may not be able to add sprinkler systems. We are
proposing to retain our existing authority to waive specific provisions
of the LSC on a case-by-case basis, further reducing the exposure to
additional cost and burden for facilities with unique situations that
can justify the application of waivers which we determine will not
endanger the health and safety of patients. We propose that a waiver
may be granted for a specific LSC requirement if: (1) We determine that
the waiver would not adversely affect the patient/staff health and
safety; and (2) we determine that it would impose an unreasonable
hardship on the facility to meet a specific LSC requirement. A provider
may request a waiver from its State Agency. The State Agency will
review the request and make a recommendation to the appropriate CMS
Regional Office. The CMS Regional Office will review the waiver request
and the State Agency's recommendation and make a final decision on the
waiver request. A waiver cannot be granted if patient safety is
compromised in any way.
A State may also request that a State fire and safety code, imposed
by State law, be applicable to all dialysis facilities rather than the
LSC proposed in this rule. The State must submit the request to its CMS
Regional Office and the Regional Office will forward the State's
request to CMS Central office for a final determination.
V. Proposed Part 494 Subpart C (Patient Care)
A. Patients' Rights (Sec. 494.70)
[If you choose to comment on issues in this section please include the
caption ``Patients' Rights'' at the beginning of your comment.]
The existing patients' rights condition, Sec. 405.2138, requires
that the facility's governing body adopt written patients' rights
policies that are administered by the facility's chief executive
officer (CEO). Sections 405.2138(a)(1) through (5) state that patients
must be informed regarding the following: (1) Their rights and
responsibilities; (2) services available at the facility and charges
not covered; (3) their medical condition (by a physician); (4) the
facility's reuse policies; and (5) their suitability for
transplantation or home dialysis. Sections 405.2138(b)(1) and (2)
afford patients the right to participate in planning their medical
treatment; require that a patient may be transferred or discharged for
only medical reasons or for the patient's or other patient's welfare or
nonpayment of fees; and require that patients must be given advance
notice to ensure an orderly transfer or discharge. Section 405.2138(c)
states that patients must be treated with respect and dignity; Sec.
405.2138(d) protects patient confidentiality of personal and medical
records; and Sec. 405.2138(e) states patients must be advised,
encouraged, and assisted in exercising their rights to bring grievances
(through a representative, if desired) without fear of discrimination
or reprisal.
We are proposing to revise the provisions of this condition to
include a number of changes, in keeping with our goals to reduce the
Federal regulatory burden on dialysis facilities, eliminate unnecessary
procedural requirements, and revise the conditions for coverage to be
more outcome-oriented while protecting the basic rights of ESRD
patients.
First, we are proposing at Sec. 494.70 that the facility must
inform patients (or their representatives) of their rights and
responsibilities when they begin their treatment at the facility, and
must also protect and provide for the exercise of those rights. We
believe it is important to take steps to ensure that patients are fully
and promptly informed of their rights. The existing regulatory language
permits a facility an unspecified period of time to complete this
activity. However, we believe that all dialysis patients must be
informed of their rights and responsibilities when they begin their
treatment, which is the standard practice in dialysis facilities, so
they may exercise them from the beginning of their relationship with
the facility.
Existing Sec. 405.2138 provides a list of numerous persons to whom
these written patient rights policies must be ``made available.'' The
list includes patients and guardians, next of kin, sponsoring agencies,
representative payees, and the public. Essentially, the facility must
provide the list of patient rights to anyone who asks to see them.
Rather than specifying a list of people to whom the patients' rights
policies must be made available, we are proposing at Sec. 494.70 that
facilities inform the patients (or their representatives), and at Sec.
494.7