Medicare Program; Conditions for Coverage for End Stage Renal Disease Facilities

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.

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.

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.

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 § 494.1)

B. Definitions (Proposed § 494.10)

C. Compliance with Federal, State, and Local Laws and Regulations (Proposed § 494.20)

IV. Provisions of Proposed Part 494 Subpart B (Patient Safety)

A. Infection Control (Proposed § 494.30)

B. Water Quality (Proposed § 494.40)

C. Reuse of Hemodialyzers and Bloodlines (Proposed § 494.50)

D. Physical Environment (Proposed § 494.60)

V. Provisions of Proposed Part 494 Subpart C (Patient Care)

A. Patients' Rights (Proposed § 494.70)

B. Patient Assessment (Proposed § 494.80)

C. Patient Plan of Care (Proposed § 494.90)

1. Development of the Patient Plan of Care (Proposed § 494.90(a))

a. Dose of Dialysis (Proposed § 494.90(a)(1))

b. Nutritional Status (Proposed § 494.90(a)(2))

c. Anemia (Proposed § 494.90(a)(3))

d. Vascular Access (Proposed § 494.90(a)(4))

e. Transplantation Status (Proposed § 494.90(a)(5))

f. Rehabilitation Status (Proposed § 494.90(a)(6))

g. Social Services

2. Implementation of the Patient Plan of Care (Proposed § 494.90(b))

3. Transplantation Referral (Proposed § 494.90(c))

4. Patient Education and Training (Proposed § 494.90(d))

D. Care at Home (Proposed § 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 § 494.110)

1. Program Scope (Proposed § 494.110(a))

2. Monitoring Performance Improvement (Proposed § 494.110(b))

3. Prioritizing Improvement Activities (Proposed § 494.110(c))

4. Facility Specific Standards of Enforcement

F. Special Purpose Renal Dialysis Facilities (Proposed § 494.120)

G. Laboratory Services (Proposed § 494.130)

VI. Provisions of Proposed Part 494 Subpart D (Administration)

A. Personnel Qualifications (Proposed § 494.140)

1. Medical Director (Proposed § 494.140(a))

2. Nursing Services (Proposed § 494.140(b))

3. Dietitian (Proposed § 494.140(c))

4. Social Worker (Proposed § 494.140(d))

5. Patient Care Dialysis Technicians (Proposed § 494.140(e))

6. Other Personnel Issues

B. Responsibilities of the Medical Director (Proposed § 494.150)

C. Relationship with the ESRD Network (Proposed § 494.160)

D. Medical Records (Proposed § 494.170)

E. Governance (Proposed § 494.180)

1. Existing Requirements for Governing Bodies

2. Overview of the Proposed Governance Requirements

3. Governance Condition (Proposed § 494.180)

4. Designating a Chief Executive Officer or Administrator (Proposed § 494.180(a))

5. Adequate Number of Qualified and Trained Staff (§ 494.180(b))

6. Medical Staff Appointments (Proposed § 494.180(c))

7. Furnishing Services (Proposed § 494.180(d))

8. Internal Grievance Process (Proposed § 494.180(e))

9. Discharge and Transfer Policies and Procedures (Proposed § 494.180(f))

10. Emergency Coverage (Proposed § 494.180(g))

11. Furnishing Data and Information for ESRD Program Administration (Proposed § 494.180(h))

12. Disclosure of Ownership (Proposed § 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;

• 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

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

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 § 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

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

(hemodialysis only) and the nation. Therefore, we are proposing in the Governance condition for coverage (§ 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

§ 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 § 405.2180 through § 405.2184 will be recodified to § 488.604 through § 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

§ 494.1 Basis and scope.

§ 494.10 Definitions.

§ 494.20 Compliance with Federal, State, and local laws and regulations.

Subpart B—Patient Safety

§ 494.30 Condition: Infection control.

§ 494.40 Condition: Water quality.

§ 494.50 Condition: Reuse of hemodialyzers and other dialysis supplies.

§ 494.60 Condition: Physical environment.

Subpart C—Patient Care

§ 494.70 Condition: Patient rights.

§ 494.80 Condition: Patient assessment.

§ 494.90 Condition: Patient plan of care.

§ 494.100 Condition: Care at home.

§ 494.110 Condition: Quality assessment and performance improvement.

§ 494.120 Condition: Special purpose renal dialysis facilities.

§ 494.130 Condition: Laboratory services.

Subpart D—Administration

§ 494.140 Condition: Personnel qualifications.

§ 494.150 Condition: Responsibilities of the medical director.

§ 494.160 Condition: Relationship with ESRD network.

§ 494.170 Condition: Medical recordkeeping.

§ 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 § 494.1)

[If you choose to comment on issues in this section please include the caption “Basis” at the beginning of your comment.]

Proposed § 494.1, identifies the statutory authority for the regulations. Proposed § 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 § 405.2100, Scope of subpart, which consists largely of a description of the contents of the existing ESRD conditions for coverage.

B. Definitions (Proposed § 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 § 494.10, we set forth definitions for terms used in the ESRD conditions. Existing § 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 § 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 § 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 § 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 § 494.100(a) of this part.

•

Interdisciplinary team

(as required in § 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 § 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 § 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 § 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 § 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 § 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

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 (§ 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 § 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†

HBV susceptible, including non-responders to vaccine

HBsAg

Anti-HBs positive(>10 mIU/mL), anti-HBc negative

Anti-HBs

Anti-HBs and anti-HBc positive

No additional HBV testing needed

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.

• 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://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 § 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 § 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 § 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 § 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

infection (§ 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 § 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 (§ 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 § 405.2140(b).

Existing § 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 § 405.2140(b)(1). In this proposed rule, reporting requirements for communicable diseases are listed at § 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 § 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 § 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

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 § 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 § 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 § 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 § 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 § 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 § 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 § 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 (§ 494.40(d)).

If chlorine/chloramine levels in treated water from the last backup component (or carbon tank) are above the AAMI standards as required in proposed § 494.40(a)(1)(ii), dialysis treatments must be immediately stopped to protect patients from exposure to chlorine/chloramine as proposed in § 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 § 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 (§ 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 § 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 § 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 § 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 § 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 § 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 § 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 § 405.2150(a)(3) requires that facilities take appropriate blood cultures at the time a patient has a febrile response and discontinue reuse of

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 § 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 § 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 § 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 (§ 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 § 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 § 494.60(a) and equipment in proposed § 494.60(b). We propose to maintain the existing requirement (described in § 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 § 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 § 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 § 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 § 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 § 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 § 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 § 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

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 § 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 § 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 § 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 § 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 (§ 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 § 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 (

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

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 § 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 § 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 § 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 § 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 (§ 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 § 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

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 (§ 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, § 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; § 405.2138(d) protects patient confidentiality of personal and medical records; and § 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 § 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 § 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 § 494.70 that facilities inform the patients (or their representatives), and at § 494.70(c) that facilities post a copy of the patients' rights in a prominent location where it can easily be seen and read. This not only meets the objectives of the current list of disclosures, it also allows patients

to review their rights at any time during the course of their care at the dialysis facility.

Section 405.2138 also states that the CEO is responsible for the development of, and adherence to, procedures implementing the patients' rights policies. In § 494.70, we are proposing to change this requirement by holding the facility accountable for the outcome, which is to ensure that each patient's rights and the ability to exercise them are protected.

We are proposing to retain the patients' rights enumerated in § 405.2138(a)(1) through (a)(5) and include them in the proposed § 494.70(a).

Proposed § 494.70(a)(1) requires the dialysis facility to inform patients of their right to be treated with respect, dignity, and recognition of their individuality and personal needs as well as sensitivity to the patients' psychosocial needs and ability to cope with ESRD.

Proposed § 494.70(a)(2) requires a dialysis facility to provide information to patients in an understandable manner. The existing requirement at § 405.2138(c) requires dialysis facilities to provide translators “where a significant number of patients exhibit language barriers.” Presumably, under this existing requirement, if a single patient has language difficulty, the facility does not need to act to address this patient's needs. We are proposing to modify this requirement. Since written information is not required, the dialysis facility has the flexibility to decide the best vehicle for providing information to patients. We believe this more outcome-oriented requirement provides a facility with the latitude to devise its own means to ensure the outcome is met.

Proposed §§ 494.70(a)(3) and (4) would require a dialysis facility to inform patients regarding privacy and confidentiality, and also expands those rights to include specific references to privacy and confidentiality in all aspects of the patient's treatment as well as the patient's medical records. These requirements include existing provisions from § 405.2138(c) and (d). Staff should be instructed that any discussions with dialysis patients or relatives regarding treatment, the patient care plan, and medical conditions should be held in private and kept confidential. There should be reasonable precautions to keep both written and verbal patient information private. Staff should be aware of the need to speak at a volume and at a proximity to patients such that privacy is reasonably protected. Facility staff must make efforts to protect patient information and physical privacy. While recognizing the patient's right to privacy and confidentiality, we are not necessarily advocating physical barriers in the dialysis clinical area that provide patient privacy because patients should be in view of staff at all times during treatment to ensure safety. However, in situations when there is patient body exposure during therapy, the staff should be instructed to provide temporary screens, curtains, or blankets.

We are proposing at § 494.70(a)(5) to retain the existing requirement under § 405.2138(b)(1) that describes the right of patients to participate in the planning of their medical treatment and to refuse to participate in experimental research (or any part of their care). Section 494.70(a)(5) requires a facility to inform patients regarding their right to participate in all aspects of their care. Although we recognize that a facility cannot require its patients to participate in the care process, we expect the facility to work closely with patients and encourage patient participation to ensure that a care plan is developed that is suitable to the needs and concerns of both the patient and staff. The facility should notify patients in advance, if possible, of any changes in the treatment plan recommended by the physician and the basis for the changes. The facility should also encourage patients to disclose any concerns they may have with the proposed changes.

Proposed § 494.70(a)(5) would also require the facility to inform patients of the right to establish an advance directive. Advance directives establish in writing an individual's preference with respect to the degree of medical care and treatment desired or who should make treatment decisions if the individual should become incapacitated and lose the ability to make or communicate medical decisions. Advance directives include written documents including living wills and durable powers of attorney for health care, as recognized by State law.

Congress passed section 4206 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) (Pub. L. 101-508) to ensure that patients receive information regarding their right to execute or not to execute advance directives. While the OBRA 1990 requires hospitals, skilled nursing facilities, HHAs, managed care plans, and hospice programs participating in the Medicare program to establish and maintain written policies and procedures regarding advance directives, it does not specifically mention dialysis facilities.

In proposing to add advance directives to the patients' rights condition for coverage we took several factors into consideration. First is the chronic nature of ESRD. Kidney impairment is irreversible and permanent, and a regular course of dialysis or transplantation is essential to maintain life. In addition, we considered the amount of time a patient spends in the dialysis unit, and also the rapidly changing demographics of the ESRD patient population. The average age of the ESRD patient population is increasing annually. Elderly ESRD patients now comprise a large percentage of the total ESRD patient population. Data compiled by the United States Renal Data System, from 1990 to 2001, shows the following rate of new cases of ESRD for patients 65 years of age and older:

Age

(in years)

Year

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

65-69

7,177

7,982

8,597

8,895

9,852

9,643

10,390

10,829

11,078

11,225

11,415

11,545

70-74

6,159

7,260

8,093

8,533

9,664

9,678

10,753

11,248

11,648

12,005

12,276

12,367

75-79

4,587

5,367

5,997

6,293

7,243

7,404

8,481

9,339

10,133

11,170

11,407

11,408

80-84

2,386

2,754

3,228

3,427

4,051

4,290

4,959

5,725

6,125

6,785

7,349

7,477

85+

961

1,113

1,277

1,481

1,659

1,833

2,248

2,598

3,110

3,587

3,870

4,146

The emergence of an older, sicker ESRD patient population has motivated the Renal Physicians Association (RPA) and the NKF to develop guidelines for implementation of advance directives in dialysis facilities, and we are encouraging dialysis facilities to adopt voluntary consensus guidelines for advance directives. The guidelines can be obtained through the NKF's Web site at:

http://www.kidneyva.org/public_ed/orderforms.pdf

and through the RPA

Web site at

http://www.renalmd.org/publications/index.cfm.

After taking these factors into account, we believe it is prudent to consider adding advance directives as a requirement in the patients' rights condition of this proposed rule.

Existing § 405.2138(a)(5) requires that patients be informed of their suitability for transplantation or home dialysis. We have strengthened this requirement at § 494.70(a)(6) by proposing that patients be informed about alternative treatment modalities by requiring dialysis facilities to address all treatment choices. The treatment modality selected may directly affect the quality of life for dialysis patients. This choice is a very personal one, with important implications for how likely the patient is to be rehabilitated to the highest possible level. To assist dialysis patients in achieving the optimal quality of life, patients need education about each modality and must have access to the widest array of treatment choices possible.

For example, a successful kidney transplant is the most desirable treatment for many ESRD patients and facilities should make every effort to both educate and inform patients regarding the transplantation option. Also, forms of dialysis that can be performed at home have been shown to have a positive influence on the patient's quality of life. Home dialysis affords patients' control over scheduling and setting, and it can be done in comfortable, familiar surroundings. Also, home dialysis is generally perceived to be less disruptive to family life and employment. We propose to require that a facility inform patients about all available treatment modalities and settings, so patients can make an informed decision regarding the most appropriate course of treatment that meets their needs.

Open communication between the facility staff and the patient and patient access to treatment information are vital tools for enhancing the patient's participation in his or her coordinated care planning. Proposed § 494.70(a)(7) requires that patients be informed of the facility's patient care policies, including its patient isolation policies.

Proposed §§ 494.70(a)(8) through (10) retain existing requirements in § 405.2138(a)(2) through (4) that patients be fully informed regarding the facility's reuse of dialysis supplies, including hemodialyzers; be informed by a physician regarding his or her own medical condition unless contraindicated; and be informed of services available in the facility and charges not covered by Medicare.

Proposed § 494.70(a)(11) would require that patients be informed of the right to receive the necessary services outlined in the patient plan of care in proposed § 494.90. The importance of the patient plan of care is discussed in section V.C. of this preamble.

Proposed § 494.70(a)(12) would retain the existing requirement at § 405.2138(a)(1) that patients be informed of the rules and expectations of the facility regarding patient conduct and responsibilities. The success of the dialysis treatment is as contingent upon patients adhering to their responsibilities as it is upon other important factors. There is a discussion of the dialysis facility's responsibility regarding disruptive and difficult patients in section VI.E.9. of this preamble.

Proposed § 494.70(a)(13) would require facilities to inform patients regarding the facility's internal grievance process and their right to express grievances against the facility using the internal grievance process through a representative chosen by the patient (if so desired).

Proposed § 494.70(a)(14) strengthens the existing requirement for facilities to inform patients regarding the various external grievance mechanisms available to them, including how to contact the ESRD network and the State survey agency, and how to file external grievances without reprisal or denial of services, through a representative chosen by the patient or anonymously (if so desired). We believe that patients must be made aware of every grievance option available to them, including, at a minimum, contacting the two entities with the statutory responsibility under Federal law for addressing patient grievances (that is, the ESRD networks and the State survey agencies).

In proposed §§ 494.70(b)(1) and (2), we would require a facility to inform patients regarding its transfer and discharge policies and provide 30 days notice in advance of reducing or terminating patient care services following the discharge and transfer procedure outlined in § 494.180(f). The facility would be exempt from the 30-day notification requirement in cases when there was an immediate threat to the health and safety of others. Proposed §§ 494.70(b)(1) and (b)(2) and the procedure outlined at § 494.180(f) have been proposed, in part, in response to the “disruptive” or “challenging” patient issue. Increasing numbers of staff and patient grievances presented to the ESRD networks and the State survey agencies involve allegations of disruptive behavior by patients and allegations of inappropriate patient discharges from facilities for noncompliance or disruptive behavior. We would not expect a patient to be involuntarily discharged from a dialysis facility for failure to follow the instructions of a facility staff member. However, it may be necessary to discharge a disruptive patient in order to protect the rights and safety of other patients in the facility, or to protect the safety of facility staff.

We believe that a dialysis facility has both the resources and a responsibility to make a good faith effort to work with every patient, including patients perceived to be disruptive or challenging, to provide the necessary assessment, training, knowledge, and motivation to facilitate good outcomes of care. This process begins when the facility interdisciplinary team performs the comprehensive patient assessment described in proposed § 494.80, with periodic reassessments as needed; continues through the care planning process described in proposed § 494.90; as well as the facility's quality assessment and performance improvement (QAPI) program described in proposed § 494.110. We believe the disruptive or challenging patient problem is multifaceted, and even conscientious assessments, care planning, and QAPI programs by a facility will not always be successful in mitigating the disruptive behavior of some patients. In those instances when good faith efforts by a facility have been unsuccessful and the facility has determined that it wants to discharge or transfer the patient, facilities must follow the procedure outlined in proposed § 494.180(f), and arrange to transfer or discharge the patient, as appropriate.

We also recognize there will be rare instances when a facility must act immediately to discharge a patient. Such instances could be, for example, when a patient physically harms or threatens other patients and staff, a patient who brings weapons or illegal drugs into a facility, or a patient who is verbally abusive and disruptive to such an extreme degree that the facility is unable to operate effectively. In those and comparable circumstances, we would propose to shorten the 30-day notification requirement. We are soliciting comments on the proposed §§ 494.70(b)(1) and (b)(2), as well as suggestions for addressing the disruptive or challenging patient issue in the proposed ESRD conditions.

If a patient chooses not to use a facility's internal grievance process, or when grievances cannot be resolved at the facility level, the patient may elect to register a grievance with the

appropriate ESRD network or make a complaint directly to the State survey agency at any time. We believe it is essential that we require that patients be informed of every grievance and complaint option currently available to them under the law.

Proposed § 494.70(c) would require dialysis facilities to prominently display a copy of the patients' rights as well as the telephone numbers for the appropriate ESRD network and State survey agency in order to afford patients the opportunity to contact either entity, if desired. Dialysis patients have the right to be advised of and to use grievance processes developed by the facility, the ESRD network and the State survey agency.

B. Patient Assessment (Proposed § 494.80)

The proposed patient assessment condition at § 494.80 underscores our belief that systematic patient assessment is essential to improving quality of care and patient outcomes. The information generated from the patient assessment is a vital tool for developing a patient's care plan and subsequent treatment. A comprehensive patient assessment allows the dialysis facility to monitor the patient's progress toward achieving the desired care outcomes and adjust the plan of care and treatment prescription as necessary.

The existing regulations in part 405 subpart U do not state that a patient will receive a comprehensive assessment. However, two sections of the existing regulations, §§ 405.2136(g)(1) and 405.2137(b)(1), provide a basis for a patient assessment. For example, § 405.2136(g)(1) holds the patient's physician responsible to prescribe a planned regimen of care, “which covers indicated dialysis and other ESRD treatments, services, medications, diet, special procedures recommended for the health and safety of the patient, and plans for continuing care and discharge.” That section also states that such plans are made with the input of the professional personnel providing care to the patient. Existing § 405.2137(b)(1) states that a patient care plan “reflects the psychological, social, and functional needs of the patient,” and indicates ESRD and other care needed to achieve the long- and short-term treatment goals.

Therefore, while the existing regulations indicate that a specialized care plan must be developed based upon the nature of the patient's illness, the treatment prescribed, and an assessment of the patient's needs, it does not specify the criteria that a facility must include in a patient assessment. Over the past 25 years, research has improved our knowledge of the components important to assessing and treating the dialysis patient so that improvements in quality of life and morbidity and mortality rates have been achieved.

We believe that a comprehensive patient assessment that includes clinical interaction with the patient is a prerequisite for the delivery of quality care and is the basis for determining a patient's functional status and identifying the services necessary to address the patient's needs. Accurate and accessible patient information generated from the comprehensive assessment is critical to the development of a successful patient care plan and the achievement of desired patient outcomes.

We do not believe that expanding the existing requirements in this proposed condition will impose any additional burden on facilities. Rather, we believe quality-oriented facilities already routinely perform comprehensive patient assessments upon initiating treatment. Further, we believe most facilities already have this information in different parts of the medical record since an appropriate and effective treatment plan cannot be developed without an initial assessment.

We are proposing at § 494.80 to add a patient assessment condition for coverage that would make the ESRD facility, through the patient's interdisciplinary team, responsible for providing each of its patients with an individualized and comprehensive assessment of his or her needs. The members of the interdisciplinary team (see proposed § 494.10) would include the patient (if he or she chooses), a registered nurse, a physician, a social worker, and a registered dietitian. With the team concept, the goal is to obtain input from each designated health professional as well as from the patient to develop an assessment that identifies the patient's needs and allows for planning for necessary services. The proposed team members represent vital components of the patient's medical treatment and psychosocial development. These professionals are also key to a successful transition to dialysis as well as to maintaining the patient's quality of life. An assessment that involves the patient as a key member of the interdisciplinary team is important to the successful delivery of service and the patient's adherence to the program.

In proposed § 494.80(a), we list the assessment criteria. The minimum proposed elements of a patient's assessment include the following:

• Evaluation of current health status, including comorbid conditions and medical condition.

• Evaluation of the appropriateness of the dialysis prescription, blood pressure control, and fluid management needs.

• Laboratory profile and medication history.

• Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of recombinant erythropoietin.

• Evaluation of factors associated with renal bone disease.

• Evaluation of nutritional status.

• Evaluation of psychosocial needs.

• Evaluation of dialysis access type and maintenance.

• Evaluation of the patient's ability, interests, preferences, and goals, including level of participation in the dialysis care process; modality and setting (for example, home dialysis, including home hemodialysis or peritoneal dialysis); and expectations for care outcomes.

• Evaluation of suitability for transplantation referral, based on criteria developed by the transplant surgeon at the transplant center that would receive such transplantation referral including the basis for referral or nonreferral.

• Evaluation of family and other support systems.

• Evaluation of current physical activity level.

• Evaluation of vocational and physical rehabilitation status and potential.

Other information to be included in the initial assessment would be determined by the interdisciplinary team based on the specific characteristics and needs of the patient.

We recognize that inclusion of a minimum set of assessment criteria may appear to be inconsistent with our goal of eliminating unnecessarily prescriptive and process-oriented requirements. However, we believe it is appropriate and necessary for every patient assessment to focus not only on the patient's medical needs, but also on his or her psychosocial and rehabilitation needs. Further, these assessment criteria would assure that needed information would be available for the patient plan of care and the facility's quality assurance and performance improvement program.

We propose criteria for the frequency of assessment and reassessment of new patients in §§ 494.80(b)(1) and (2). A timely, comprehensive assessment is critical for planning patient care and achieving desired patient outcomes. We

believe this requirement, though process-oriented, is necessary to prevent harm to the patient. By permitting facilities 20 calendar days to complete assessments, we are providing a reasonable timeframe for every member of the team to assess the patient prior to development of the treatment plan.

We also recognize that patients who are new to dialysis need time to adjust and adapt to the treatment. Initially, patients may experience a great deal of anxiety while learning self-care skills, modifying their diet, changing their behavior, and perhaps dealing with access issues. The level of compliance with the renal regimen may be set by the time the person has been on dialysis for 4 to 6 months (Sciarini, pp. 299-305). Because of this period of adjustment, and the opportunity to establish the patient's adherence to the renal regimen, proposed § 494.80(b)(2) would require a follow-up comprehensive reassessment for new patients within 3 months after the completion of the initial comprehensive assessment. Three months was chosen so that the window of opportunity for establishing adherence to the renal regimen by a new patient is not missed. We recognize the additional burden this 3-month reassessment will place on the interdisciplinary team. However, an updated plan of care and the attention to the patient's adjustment to the renal regimen may prevent problems in the coming months. The reassessment also ensures the continued accuracy and effectiveness of the treatment regimen.

Existing § 405.2136(g) states that the physician responsible for the patient's medical supervision evaluates the patient's needs and prescribes a planned regimen of care for dialysis. Sections 494.80(c)(1) and (2) propose a schedule for the assessment of the treatment prescription for hemodialysis and peritoneal dialysis patients. Studies indicate that ESRD patient mortality is lower when patients receive sufficient dialysis treatments. There has been considerable research recently indicating that the dose of dialysis is an important determinant of survival and morbidity of patients on hemodialysis ((Held, pp.871-875); (Owen, pp.1001-1006); (Parker, pp.981-989); and (Parker, pp.670-680)). The delivered dose of dialysis (Kt/V or an equivalent measure) indicates how well the dialysis treatment is working. Kt/V is the dialyzer clearance of urea (K) times the time of treatment (t), divided by the volume of distribution of urea (V), which yields a dimensionless value. Adequacy of dialysis clinical practice guidelines are available in the National Kidney Foundation's Kidney Disease Quality Initiative (NKF-K/DOQI). As previously discussed in this preamble, the NKF-K/DOQI has established clinical practice guidelines for ESRD patients. This systematic, evidence-based approach to developing guidelines used focus workgroups to identify target issues and conducted extensive literature searches to extract relevant clinical study reports for each target issue. Clinical practice guidelines were derived from this information. The guidelines are available for public review and comment, and they continue to be reviewed. Health care professionals and providers, ESRD networks, managed care groups, industry, government, patient associations and individuals are invited to provide comments to the NKF-K/DOQI workgroups. These comments are reviewed and when appropriate, incorporated in future editions.

An important initiative of this project is the development of guidelines for the dose of dialysis, including standard methodology(ies) for measuring the dialysis dosage.

To ensure that ESRD patients receive sufficient dialysis, the delivered dose of dialysis needs to be measured. Therefore, in keeping with the NKF's K/DOQI clinical practice guidelines, we propose in § 494.80(c) to specify that the delivered dose of dialysis for the patient's hemodialysis treatment prescription must be measured at least monthly, and the patient's peritoneal dialysis treatment prescription should be assessed at least every 4 months. More frequent monitoring may be necessary for new dialysis patients or when the dialysis prescription is changed. Less frequent monitoring of the adequacy of dialysis may compromise the timeliness with which deficiencies in the delivered dose of dialysis are identified and hence may delay implementation of corrective action.

In §§ 494.80(d)(1) and (2) we propose patient reassessment timeframes for both stable and unstable patients with respect to the standards specified in §§ 494.80(a)(1) through (a)(13). The comprehensive assessment process can be seen as part of a cycle. Through the use of the patient assessment, accurate and timely patient information is reflected in the plan of care. As the assessment changes, the plan of care must be revised accordingly. If the patient's condition is stable, we propose in § 494.80(d)(1) that the facility must perform comprehensive reassessments at least annually, which assures that patients are receiving a continuing program of care that meets their needs. This proposed timeframe minimizes the facility burden because the existing § 405.2137(b)(4) requires care plan review every 6 months for stable patients. If the patient is unstable, we are proposing in § 494.80(d)(2) to require a monthly reassessment, to allow for the update of the plan of care. Existing § 405.2137(b)(4) also requires a monthly review of the care plan for patients whose medical condition has not become stabilized. In proposed §§ 494.80 (d)(2)(i) through (d)(2)(iv), we added criteria to specify at a minimum, which patients may be considered to be unstable patients. These criteria include extended or frequent hospitalizations, marked deterioration in health status, a significant change in psychosocial needs, or poor nutritional status, with unmanaged anemia and inadequate dialysis. Extremely frail patients may need monthly reassessments. However, we are not proposing a specific requirement for monthly reassessments for frail patients because we believe this type of requirement would be too prescriptive and limit the flexibility of dialysis facilities to make clinical determinations on a case-by-case basis.

The renal community has been unable to reach a consensus regarding the optimum frequency of assessments. Some believe that the proposed time periods create a strain on facilities, while others have encouraged us to propose more stringent timeframes. Because of the wide range of opinion in this matter, we are specifically soliciting public comments on whether the proposed 3-month timeframe for reassessment of new patients is reasonable and consistent with meeting the patient's needs.

C. Patient Plan of Care (Proposed § 494.90)

[If you choose to comment on issues in this section please include the caption “Plan of Care” at the beginning of your comments.]

The patient assessment serves as the basis for the patient plan of care. Existing § 405.2137 contains a large number of prescriptive requirements for the development of patient care plans. These requirements specify that there needs to be a patient long-term program and a patient care plan.

The patient long-term program described in existing §§ 405.2137(a)(1) through (a)(4) relates to the selection of a suitable treatment modality and treatment setting by the treatment team. It also requires active participation by the physician director in the unit where the patient is being treated, a formal review of the written long-term plan by the team every 12 months, patient involvement in the plan's development,

and a requirement to send the plan to the receiving facility within 1 day of an interfacility transfer.

The patient care plan in existing § 405.2137(b) requires a written care plan based on the nature of the patient's illness, the treatment prescribed, and an assessment of the patient's needs. Additional requirements in existing §§ 405.2137(b)(1) through (b)(7) include a personalized care plan reflecting the patient's needs, a care plan developed by a professional team (including the physician responsible for the patient's care), the involvement of the patient (or the patient's parent or legal guardian), a monthly review for unstable patients, a 6 month review for stable patients, sending the plan to the receiving facility within one day for interfacility transfers, periodic monitoring of home dialysis patients, and monitoring for home dialysis patients who use erythropoietin.

In accordance with our goal of reducing Federal regulatory burden, we have simplified the proposed patient care plan condition (§ 494.90) by eliminating the separate requirement for a patient long-term program.

We propose to retain some of the existing requirements of § 405.2137 in the patient assessment condition (proposed § 494.80). We believe that the patient assessment and patient care planning processes are inextricably linked. That is, each patient assessment must be followed with a review and revision, if necessary, of the patient's plan of care.

The comprehensive plan of care is an individualized program that ensures that each dialysis patient receives personalized and appropriate patient care within the selected modality and setting of treatment. In proposed § 494.90 we would specify that the patient's plan of care must include measurable and expected outcomes and estimated timetables to meet the patient's medical and psychosocial needs as identified in the initial and subsequent comprehensive assessments. This section would also specify that the patient's plan of care must address all the services that are to be furnished to achieve and maintain the expected outcomes of care.

Existing §§ 405.2137(a)(1) and 405.2137(b)(2) specify the composition of the professional team responsible for the preparation of the long-term and the patient care plans. The facility's professional team currently writes a patient long-term program and a short-term care plan. However, proposed § 494.90 would require that a single patient plan of care be developed and this plan would address all of the patient's needs. We are proposing in § 494.90 to retain the existing requirement that the patient plan of care to be developed by the interdisciplinary team. Although we would retain the existing §§ 405.2137 (a)(1) and (2), we have chosen to use the term “interdisciplinary team.” The term “interdisciplinary team” is defined § 494.10 and described in § 494.80. In § 494.80, we are proposing that the interdisciplinary team consist of, at a minimum, the patient (if he or she desires) or his/her designee, a registered nurse, a nephrologist or physician treating the patient for ESRD, a social worker, and a dietitian. We are using the term “interdisciplinary team” instead of “professional team” because the term “interdisciplinary team” is commonly used in health care settings, including dialysis facilities.

Although existing § 405.2137(a)(1) specifies a transplant surgeon as a member of the professional team, we did not include a transplant surgeon as a member of the interdisciplinary team as defined in proposed § 494.10 and described in proposed § 494.80. We believe all eligible ESRD patients must be referred for transplantation. However, it may not be reasonable to have transplant surgeons sign every care plan. The existing interpretive guidelines for surveyors (Survey Procedures and Interpretive Guidelines for End-Stage Renal Disease Facilities, Appendix H, State Operations Manual) allow a transplant surgeon's designee, who could be a transplant coordinator or the treating nephrologist, to screen patients in the long-term care plan process (DHHS/CMS, April 1995). The designee would have to use screening criteria developed by the transplant surgeon. Because not every patient is medically suited for a transplant, we believe the transplant surgeon need not be involved with the team unless a possible candidate has been identified. We are proposing that the dialysis facility must have inclusion/exclusion criteria, defined by the transplant surgeon based at the transplant center that would receive the transplantation referral, to use in the evaluation of patients for transplant referral. Therefore, we propose to delete the requirement that a transplant surgeon directly sign the care plan. We believe transplant referral tracking must be part of the comprehensive plan of care condition (

see

§ 494.90(c)), and we have also proposed to strengthen this requirement in the patient assessment (§ 494.80) and patient's rights (§ 494.70) conditions. We are soliciting comment on the appropriate role of the transplant surgeon in developing the patient plan of care.

Existing § 405.2137(a)(1) also requires that the facility medical director and a physician from a facility that offers home dialysis (if the patient's present facility does not) be included in the team that develops the patient's long-term program. While we believe the involvement of these physicians would be valuable in most cases, we recognize that there are situations when the services of these physicians may not be needed. Thus, in keeping with our goal of eliminating unnecessary process requirements, proposed § 494.10 specifies the definition of “interdisciplinary team” without including the facility medical director and the home dialysis physician. Nonetheless, we encourage facilities to expand the interdisciplinary team to include as many health professionals as necessary to furnish the best care possible to their patients.

As required in existing § 405.2137 and in proposed § 494.10, a physician is part of the interdisciplinary team. We propose retention of this requirement because we believe the physician must play an integral role on the interdisciplinary team. The physician responsible for the patient's dialysis treatment works with the other team members to ensure the development of an appropriate care plan for the patient. We also expect the physician to see the patients and monitor their care.

Existing § 405.2137(b)(3) specifies that the patient may be involved in the development of the care plan and consideration is given to the patient's preferences. The patient's right to be informed about and participate within the interdisciplinary team is encompassed in proposed § 494.70(a)(5). The patient or his/her designee, if he or she desires, as a member of the interdisciplinary team, must collaborate to design a plan of care that enables the patient to reach his or her desired level of general health, activity, and quality of care. When a patient communicates his or her goals regarding their medical treatment, he or she plays a more active role in improving their quality of life. We have eliminated the phrase “due consideration is given to [the patient's] preferences” because we believe it implies the patient (or the patient's designee) is not an equal member of the team. Each patient must be given the opportunity to participate with the interdisciplinary team. However, we would not require them to do so in the proposed requirements because we recognize that some patients may not wish to participate in the team process. We are proposing that the patient or

designee must sign the plan of care to assure the patient is aware of treatment plans and goals regardless of whether the patient has opted to participate in the care planning team process.

The patient plan of care must include measurable and expected outcome targets or goals for each patient based on the individual patient's assessment. These outcome targets must allow the patient to achieve current evidence-based community-accepted standards. Currently, the K/DOQI clinical practice guidelines are the community-accepted standards for individual patient care and we expect ESRD facilities to reflect the

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