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Table of Contents
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. l302 and l395hh).
Source: 73 FR 20475, Apr. 15, 2008, unless otherwise noted.
(a) Statutory basis. This part is based on the following provisions:
(1) Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-603), which extended Medicare coverage to insured individuals, their spouses, and their dependent children with ESRD who require dialysis or transplantation.
(2) Section 1861(e)(9) of the Act, which requires hospitals to meet such other requirements as the Secretary finds necessary in the interest of health and safety of individuals who are furnished services in the institution.
(3) Section 1861(s)(2)(F) of the Act, which describes “medical and other health services” covered under Medicare to include home dialysis supplies and equipment, self-care home dialysis support services, and institutional dialysis services and supplies.
(4) Section 1862(a) of the Act, which specifies exclusions from coverage.
(5) Section 1881 of the Act, which authorizes Medicare coverage and payment for the treatment of ESRD in approved facilities, including institutional dialysis services, transplantation services, self-care home dialysis services, and the administration of erythropoiesis-stimulating agent(s).
(6) Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113), which requires Federal agencies to use technical standards that are developed or adopted by voluntary consensus standards bodies, unless their use would be inconsistent with applicable law or otherwise impractical.
(b) Scope. The provisions of this part establish the conditions for coverage of services under Medicare and are the basis for survey activities for the purpose of determining whether an ESRD facility's services may be covered.
As used in this part—
Dialysis facility means an entity that provides outpatient maintenance dialysis services, or home dialysis training and support services, or both. A dialysis facility may be an independent or hospital-based unit (as described in §413.174(b) and (c) of this chapter) that includes a self-care dialysis unit that furnishes only self-dialysis services.
Discharge means the termination of patient care services by a dialysis facility or the patient voluntarily terminating dialysis when he or she no longer wants to be dialyzed by that facility.
Furnishes directly means the ESRD facility provides the service through its own staff and employees or through individuals who are under direct contract to furnish these services personally for the facility.
Home dialysis means dialysis performed at home by an ESRD patient or caregiver who has completed an appropriate course of training as described in §494.100(a) of this part.
Self-dialysis means dialysis performed with little or no professional assistance by an ESRD patient or caregiver who has completed an appropriate course of training as specified in §494.100(a) of this part.
Transfer means a temporary or permanent move of a patient from one dialysis facility to another that requires a transmission of the patient's medical record to the facility receiving the patient.
The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements.
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
(a) Standard: Procedures for infection control. The facility must demonstrate that it follows standard infection control precautions by implementing—
(1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009.
(ii) When dialysis isolation rooms as required by (a)(1)(i) are available locally that sufficiently serve the needs of patients in the geographic area, a new dialysis facility may request a waiver of such requirement. Isolation room waivers may be granted at the discretion of, and subject to, additional qualifications as may be deemed necessary by the Secretary.
(2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I-IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters, in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html.
(3) Patient isolation procedures to minimize the spread of infectious agents and communicable diseases; and
(4) Maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the—
(i) Handling, storage, and disposal of potentially infectious waste; and
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
(b) Standard: Oversight. The facility must—
(1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit;
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
(3) Require all clinical staff to report infection control issues to the dialysis facility's medical director (see §494.150 of this part) and the quality improvement committee.
(c) Standard: Reporting. The facility must report incidences of communicable diseases as required by Federal, State, and local regulations.
The facility must be able to demonstrate the following:
(a) Standard: Water purity. Water and equipment used for dialysis meets the water and dialysate quality standards and equipment requirements found in the Association for the Advancement of Medical Instrumentation (AAMI) publication, “Dialysate for hemodialysis,” ANSI/AAMI RD52: 2004. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. Copies may be purchased from the Association for the Advancement of Medical Instrumentation, 3300 Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
(b) Standard: Chlorine/chloramines. (1) The water treatment system must include a component or carbon tank which removes chlorine/chloramine along with a backup component or second carbon tank in series for chlorine/chloramine removal;
(2)(i) If the test results from the port of the initial component or carbon tank referred to in section 6.2.5 of AAMI RD52:2004 are greater than 0.5 mg/L for free chlorine or 0.1 mg/L for chloramines, or equal to or greater than 0.1 mg/L of total chlorine, then the second component or carbon tank which removes chlorine/chloramine must be tested;
(ii) If the test results from the last component or carbon tank are greater than the parameters for chlorine or chloramine specified in paragraph (b)(2)(i) of this section the facility must—
(A) Immediately take corrective action to bring chlorine or chloramine levels into compliance with paragraph (b)(2)(i) of this section and confirm through testing that the corrective action has been effective, or terminate dialysis treatment to protect patients from exposure to chlorine/chloramine;
(B) Only allow use of purified water in a holding tank, if appropriate, and if testing shows water chlorine or chloramine levels that are in compliance with paragraph (b)(2)(i) of this section; and
(C) Immediately notify the medical director; and
(D) Take corrective action to ensure ongoing compliance with acceptable chlorine and chloramine levels as described in paragraph (b)(2)(i) of this section.
(c) Standard: Corrective action plan. Water testing results including, but not limited to, chemical, microbial, and endotoxin levels which meet AAMI action levels or deviate from the AAMI standards must be addressed with a corrective action plan that ensures patient safety.
(d) Standard: Adverse events. A dialysis facility must maintain active surveillance of patient reactions during and following dialysis. When clinically indicated (for example, after adverse patient reactions) the facility must—
(1) Obtain blood and dialysate cultures and endotoxin levels;
(2) Evaluate the water purification system; and
(3) Take corrective action.
(e) Standard: In-center use of preconfigured hemodialysis systems. When using a preconfigured, FDA-approved hemodialysis system designed, tested and validated to yield AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate, the system's FDA-approved labeling must be adhered to for machine use and monitoring of the water and dialysate quality. The facility must meet all AAMI RD52:2004 requirements for water and dialysate. Moreover, the facility must perform bacteriological and endotoxin testing on a quarterly, or more frequent basis, as needed, to ensure that the water and dialysate are within AAMI limits.
(a) Standard: General requirements for the reuse of hemodialyzers and bloodlines. Certain hemodialyzers and bloodlines—
(1) May be reused for certain patients with the exception of Hepatitis B positive patients;
(2) Must be reused only for the same patient; and
(3) Must be labeled for multiple reuse in accordance with the premarket notification provisions of section 510(k) of the Food, Drug, and Cosmetics Act and 21 CFR 876.5860.
(b) Standard: Reprocessing requirements for the reuse of hemodialyzers and bloodlines. A dialysis facility that reuses hemodialyzers and bloodlines must adhere to the following reprocessing guidelines:
(1) Meet the requirements of AAMI published in “Reuse of Hemodialyzers,” third edition, ANSI/AAMI RD47:2002 and RD47:2002/A1:2003. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. Copies may be purchased from the Association for the Advancement of Medical Instrumentation, 3300 Washington Boulevard, Suite 400, Arlington, VA 22201-4598.
(2) Reprocess hemodialyzers and bloodlines—
(i) By following the manufacturer's recommendations; or
(ii) Using an alternate method and maintaining documented evidence that the method is safe and effective.
(3) Not expose hemodialyzers to more than one chemical germicide, other than bleach (used as a cleaner in this application), during the life of the dialyzer. All hemodialyzers must be discarded before a different chemical germicide is used in the facility.
(c) Standard: Monitoring, evaluation, and reporting requirements for the reuse of hemodialyzers and bloodlines. In addition to the requirements for hemodialyzer and bloodline reuse specified in paragraphs (a) and (b) of this section, the dialysis facility must adhere to the following:
(1) Monitor patient reactions during and following dialysis.
(2) When clinically indicated (for example, after adverse patient reactions), the facility must—
(i) Obtain blood and dialysate cultures and endotoxin levels; and
(ii) Undertake evaluation of its dialyzer reprocessing and water purification system. When this evaluation suggests a cluster of adverse patient reactions is associated with hemodialyzer reuse, the facility must suspend reuse of hemodialyzers until it is satisfied the problem has been corrected.
(iii) Report the adverse outcomes to the FDA and other Federal, State or local government agencies as required by law.
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
(a) Standard: Building. The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff, and the public.
(b) Standard: Equipment maintenance. The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
(c) Standard: Patient care environment. (1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff.
(2) The dialysis facility must:
(i) Maintain a comfortable temperature within the facility; and
(ii) Make reasonable accommodations for the patients who are not comfortable at this temperature.
(3) The dialysis facility must make accommodations to provide for patient privacy when patients are examined or treated and body exposure is required.
(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety (video surveillance will not meet this requirement).
(d) Standard: Emergency preparedness. The dialysis facility must implement processes and procedures to manage medical and nonmedical emergencies that are likely to threaten the health or safety of the patients, the staff, or 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.
(1) Emergency preparedness of staff. The dialysis facility must provide appropriate training and orientation in emergency preparedness to the staff. Staff training must be provided and evaluated at least annually and include the following:
(i) Ensuring that staff can demonstrate a knowledge of emergency procedures, including informing patients of—
(A) What to do;
(B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated;
(C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and
(D) How to disconnect themselves from the dialysis machine if an emergency occurs.
(ii) Ensuring that, at a minimum, patient care staff maintain current CPR certification; and
(iii) Ensuring that nursing staff are properly trained in the use of emergency equipment and emergency drugs.
(2) Emergency preparedness patient training. The facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1)(i) of this section.
(3) Emergency equipment. Emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, must be on the premises at all times and immediately available.
(4) Emergency plans. The facility must—
(i) Have a plan to obtain emergency medical system assistance when needed;
(ii) Evaluate at least annually the effectiveness of emergency and disaster plans and update them as necessary; and
(iii) Contact its local disaster management agency at least annually to ensure that such agency is aware of dialysis facility needs in the event of an emergency.
(e) Standard: Fire safety. (1) Except as provided in paragraph (e)(2) of this section, by February 9, 2009, dialysis facilities that are located adjacent to high hazardous occupancies or do not provide one or more exits to the outside at grade level from the patient treatment area level, must comply with applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference at §403.744(a)(1)(i) of this chapter).
(2) Notwithstanding paragraph (e)(1) of this section, dialysis facilities participating in Medicare as of October 14, 2008 that require sprinkler systems are those housed in multi-story buildings construction Types II(000), III(200), or V(000), as defined in the 2000 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference at §403.744(a)(1)(i) of this chapter), section 18.104.22.168, which were constructed after January 1, 2008, and those housed in high rise buildings over 75 feet in height, which were constructed after January 1, 2008.
(3) If CMS finds that a fire and safety code imposed by the facility's State law adequately protects a dialysis facility's patients, CMS may allow the State survey agency to apply the State's fire and safety code instead of the Life Safety Code.
(4) After consideration of State survey agency recommendations, CMS may waive, for individual dialysis facilities and for appropriate periods, specific provisions of the Life Safety Code, if the following requirements are met:
(i) The waiver would not adversely affect the health and safety of the dialysis facility's patients; and
(ii) Rigid application of specific provisions of the Life Safety Code would result in an unreasonable hardship for the dialysis facility.
[73 FR 20475, Apr. 15, 2008, as amended at 77 FR 29031, May 16, 2012]
The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights.
(a) Standard: Patients' rights. The patient has the right to—
(1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD;
(2) Receive all information in a way that he or she can understand;
(3) Privacy and confidentiality in all aspects of treatment;
(4) Privacy and confidentiality in personal medical records;
(5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research;
(6) Be informed about his or her right to execute advance directives, and the facility's policy regarding advance directives;
(7) Be informed about all treatment modalities and settings, including but not limited to, transplantation, home dialysis modalities (home hemodialysis, intermittent peritoneal dialysis, continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis),and in-facility hemodialysis. The patient has the right to receive resource information for dialysis modalities not offered by the facility, including information about alternative scheduling options for working patients;
(8) Be informed of facility policies regarding patient care, including, but not limited to, isolation of patients;
(9) Be informed of facility policies regarding the reuse of dialysis supplies, including hemodialyzers;
(10) Be informed by the physician, nurse practitioner, clinical nurse specialist, or physician's assistant treating the patient for ESRD of his or her own medical status as documented in the patient's medical record, unless the medical record contains a documented contraindication;
(11) Be informed of services available in the facility and charges for services not covered under Medicare;
(12) Receive the necessary services outlined in the patient plan of care described in §494.90;
(13) Be informed of the rules and expectations of the facility regarding patient conduct and responsibilities;
(14) Be informed of the facility's internal grievance process;
(15) Be informed of external grievance mechanisms and processes, including how to contact the ESRD Network and the State survey agency;
(16) Be informed of his or her right to file internal grievances or external grievances or both without reprisal or denial of services; and
(17) Be informed that he or she may file internal or external grievances, personally, anonymously or through a representative of the patient's choosing.
(b) Standard: Right to be informed regarding the facility's discharge and transfer policies. The patient has the right to—
(1) Be informed of the facility's policies for transfer, routine or involuntary discharge, and discontinuation of services to patients; and
(2) Receive written notice 30 days in advance of an involuntary discharge, after the facility follows the involuntary discharge procedures described in §494.180(f)(4). In the case of immediate threats to the health and safety of others, an abbreviated discharge procedure may be allowed.
(c) Standard: Posting of rights. The dialysis facility must prominently display a copy of the patient's rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients.
The facility's interdisciplinary team consists of, at a minimum, the patient or the patient's designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient's treatment plan and expectations for care.
(a) Standard: Assessment criteria. The patient's comprehensive assessment must include, but is not limited to, the following:
(1) Evaluation of current health status and medical condition, including co-morbid conditions.
(2) Evaluation of the appropriateness of the dialysis prescription, blood pressure, and fluid management needs.
(3) Laboratory profile, immunization history, and medication history.
(4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s).
(5) Evaluation of factors associated with renal bone disease.
(6) Evaluation of nutritional status by a dietitian.
(7) Evaluation of psychosocial needs by a social worker.
(8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts, and peritoneal catheters).
(9) Evaluation of the patient's abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process; the preferred modality (hemodialysis or peritoneal dialysis), and setting, (for example, home dialysis), and the patient's expectations for care outcomes.
(10) Evaluation of suitability for a transplantation referral, based on criteria developed by the prospective transplantation center and its surgeon(s). If the patient is not suitable for transplantation referral, the basis for nonreferral must be documented in the patient's medical record.
(11) Evaluation of family and other support systems.
(12) Evaluation of current patient physical activity level.
(13) Evaluation for referral to vocational and physical rehabilitation services.
(b) Standard: Frequency of assessment for patients admitted to the dialysis facility. (1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.
(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient's plan of care specified in §494.90.
(c) Standard: Assessment of treatment prescription. The adequacy of the patient's dialysis prescription, as described in §494.90(a)(1), must be assessed on an ongoing basis as follows:
(1) Hemodialysis patients. At least monthly by calculating delivered Kt/V or an equivalent measure.
(2) Peritoneal dialysis patients. At least every 4 months by calculating delivered weekly Kt/V or an equivalent measure.
(d) Standard: Patient reassessment. In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted—
(1) At least annually for stable patients; and
(2) At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis.
The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient's needs, as identified by the comprehensive assessment and changes in the patient's condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards.
(a) Standard: Development of patient plan of care. The interdisciplinary team must develop a plan of care for each patient. The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status; and achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
(2) Nutritional status. The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient's albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate.
(3) Mineral metabolism. Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease.
(4) Anemia. The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient's hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient's anemia management needs. For a home dialysis patient, the facility must evaluate whether the patient can safely, aseptically, and effectively administer erythropoiesis-stimulating agents and store this medication under refrigeration if necessary. The patient's response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis.
(5) Vascular access. The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. The patient's vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis.
(6) Psychosocial status. The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis.
(7) Modality—(i) Home dialysis. The interdisciplinary team must identify a plan for the patient's home dialysis or explain why the patient is not a candidate for home dialysis.
(ii) Transplantation status. When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient's plan of care must include documentation of the—
(A) Plan for transplantation, if the patient accepts the transplantation referral;
(B) Patient's decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or
(C) Reason(s) for the patient's nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10).
(8) Rehabilitation status. The interdisciplinary team must assist the patient in achieving and sustaining an appropriate level of productive activity, as desired by the patient, including the educational needs of pediatric patients (patients under the age of 18 years), and make rehabilitation and vocational rehabilitation referrals as appropriate.
(b) Standard: Implementation of the patient plan of care. (1) The patient's plan of care must—
(i) Be completed by the interdisciplinary team, including the patient if the patient desires; and
(ii) Be signed by team members, including the patient or the patient's designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided.
(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d).
(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient's plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must—
(i) Adjust the plan of care to reflect the patient's current condition;
(ii) Document in the record the reasons why the patient was unable to achieve the goals; and
(iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section.
(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist, or physician's assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis.
(c) Standard: Transplantation referral tracking. The interdisciplinary team must—
(1) Track the results of each kidney transplant center referral;
(2) Monitor the status of any facility patients who are on the transplant wait list; and
(3) Communicate with the transplant center regarding patient transplant status at least annually, and when there is a change in transplant candidate status.
(d) Standard: Patient education and training. The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types.
A dialysis facility that is certified to provide services to home patients must ensure through its interdisciplinary team, that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable conditions of this part.
(a) Standard: Training. The interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in §494.10) and when the home dialysis caregiver or home dialysis modality changes. The training must—
(1) Be provided by a dialysis facility that is approved to provide home dialysis services;
(2) Be conducted by a registered nurse who meets the requirements of §494.140(b)(2); and
(3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas:
(i) The nature and management of ESRD.
(ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient's plan of care.
(iii) How to detect, report, and manage potential dialysis complications, including water treatment problems.
(iv) Availability of support resources and how to access and use resources.
(v) How to self-monitor health status and record and report health status information.
(vi) How to handle medical and non-medical emergencies.
(vii) Infection control precautions.
(viii) Proper waste storage and disposal procedures.
(b) Standard: Home dialysis monitoring. The dialysis facility must—
(1) Document in the medical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training;
(2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and
(3) Maintain this information in the patient's medical record.
(c) Standard: Support services. (1) A home dialysis facility must furnish (either directly, under agreement, or by arrangement with another ESRD facility) home dialysis support services regardless of whether dialysis supplies are provided by the dialysis facility or a durable medical equipment company. Services include, but are not limited to, the following:
(i) Periodic monitoring of the patient's home adaptation, including visits to the patient's home by facility personnel in accordance with the patient's plan of care.
(ii) Coordination of the home patient's care by a member of the dialysis facility's interdisciplinary team.
(iii) Development and periodic review of the patient's individualized comprehensive plan of care that specifies the services necessary to address the patient's needs and meets the measurable and expected outcomes as specified in §494.90 of this part.
(iv) Patient consultation with members of the interdisciplinary team, as needed.
(v) Monitoring of the quality of water and dialysate used by home hemodialysis patients including conducting an onsite evaluation and testing of the water and dialysate system in accordance with—
(A) The recommendations specified in the manufacturers' instructions; and
(B) The system's FDA-approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate. The facility must meet testing and other requirements of AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly, or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits.
(C) The dialysis facility must correct any water and dialysate quality problem for the home hemodialysis patient, and if necessary, arrange for backup dialysis until the problem is corrected if—
(1) Analysis of the water and dialysate quality indicates contamination; or
(2) The home hemodialysis patient demonstrates clinical symptoms associated with water and dialysate contamination.
(vi) Purchasing, leasing, renting, delivering, installing, repairing and maintaining medically necessary home dialysis supplies and equipment (including supportive equipment) prescribed by the attending physician.
(vii) Identifying a plan and arranging for emergency back-up dialysis services when needed.
(2) The dialysis facility must maintain a recordkeeping system that ensures continuity of care and patient privacy. This includes items and services furnished by durable medical equipment (DME) suppliers referred to in §414.330(a)(2) of this chapter.
The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility's organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS.
(a) Standard: Program scope. (1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors.
(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. The program must include, but not be limited to, the following:
(i) Adequacy of dialysis.
(ii) Nutritional status.
(iii) Mineral metabolism and renal bone disease.
(iv) Anemia management.
(v) Vascular access.
(vi) Medical injuries and medical errors identification.
(vii) Hemodialyzer reuse program, if the facility reuses hemodialyzers.
(viii) Patient satisfaction and grievances.
(ix) Infection control; with respect to this component the facility must—
(A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence;
(B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and
(C) Take actions to reduce future incidents.
(b) Standard: Monitoring performance improvement. The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.
(c) Standard: Prioritizing improvement activities. The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. The facility must immediately correct any identified problems that threaten the health and safety of patients.
A special purpose renal dialysis facility is approved to furnish dialysis on a short-term basis at special locations. Special purpose dialysis facilities are divided into two categories: vacation camps (locations that serve ESRD patients while the patients are in a temporary residence) and facilities established to serve ESRD patients under emergency circumstances.
(a) Standard: Approval period. The period of approval for a special purpose renal dialysis facility may not exceed 8 months in any 12-month period.
(b) Standard: Service limitation. Special purpose renal dialysis facilities are limited to areas in which there are limited dialysis resources or access-to-care problems due to an emergency circumstance. A special purpose renal dialysis facility may provide services only to those patients who would otherwise be unable to obtain treatments in the geographic locality served by the facility.
(c) Standard: Scope of requirements—(1) Scope of requirements for a vacation camp. A vacation camp that provides dialysis services must be operated under the direction of a certified renal dialysis facility that assumes full responsibility for the care provided to patients. A special purpose renal dialysis facility established as a vacation camp must comply with the following conditions for coverage—
(i) Infection control at §494.30;
(ii) Water and dialysate quality at §494.40 (except as provided in paragraph (c)(1)(viii) of this section);
(iii) Reuse of hemodialyzers at §494.50 (if reuse is performed);
(iv) Patients' rights and posting of patients' rights at §494.70(a) and §494.70(c);
(v) Laboratory services at §494.130;
(vi) Medical director responsibilities for staff education and patient care policies and procedures at §494.150(c) and §494.150(d);
(vii) Medical records at §494.170; and
(viii) When portable home water treatment systems are used in place of a central water treatment system, the facility may adhere to §494.100(c)(1)(v) (home monitoring of water quality), in place of §494.40 (water quality).
(2) Scope of requirements for an emergency circumstance facility. A special purpose renal dialysis facility set up due to emergency circumstances may provide services only to those patients who would otherwise be unable to obtain treatments in the geographic areas served by the facility. These types of special purpose dialysis facilities must comply with paragraph (c)(1) of this section and addition to complying with the following conditions:
(i) Section 494.20 (compliance with Federal, State, and local laws and regulations).
(ii) Section 494.60 (physical environment).
(iii) Section 494.70(a) through section 494.70(c) (patient rights).
(iv) Section 494.140 (personnel qualifications).
(v) Section 494.150 (medical director).
(vi) Section 494.180 (governance).
(d) Standard: Physician contact. The facility must contact the patient's physician, if possible, prior to initiating dialysis in the special purpose renal dialysis facility, to discuss the patient's current condition to assure care provided in the special purpose renal dialysis facility is consistent with the patient plan of care (described in §494.90).
(e) Standard: Documentation. All patient care provided in the special purpose facility is documented and forwarded to the patient's usual dialysis facility, if possible, within 30 days of the last scheduled treatment in the special purpose renal dialysis facility.
The dialysis facility must provide, or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter.
All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.
(a) Standard: Medical director. (1) The medical director must be a board-certified physician in internal medicine or pediatrics by a professional board who has completed a board-approved training program in nephrology and has at least 12-months of experience providing care to patients receiving dialysis.
(2) If a physician, as specified in paragraph (a)(1) of this section, is not available to direct a certified dialysis facility another physician may direct the facility, subject to the approval of the Secretary.
(b) Standard: Nursing services—(1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must—
(i) Be a full time employee of the facility;
(ii) Be a registered nurse; and
(iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis.
(2) Self-care and home dialysis training nurse. The nurse responsible for self-care and/or home care training must—
(i) Be a registered nurse; and
(ii) Have at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality for which the nurse will provide self-care training.
(3) Charge nurse. The charge nurse responsible for each shift must—
(i) Be a registered nurse, a licensed practical nurse, or vocational nurse who meets the practice requirements in the State in which he or she is employed;
(ii) Have at least 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis; and
(iii) If such nurse is a licensed practical nurse or licensed vocational nurse, work under the supervision of a registered nurse in accordance with state nursing practice act provisions.
(4) Staff nurse. Each nurse who provides care and treatment to patients must be either a registered nurse or a practical nurse who meets the practice requirements in the State in which he or she is employed.
(c) Standard: Dietitian. The facility must have a dietitian who must—
(1) Be a registered dietitian with the Commission on Dietetic Registration; and
(2) Have a minimum of 1 year professional work experience in clinical nutrition as a registered dietitian.
(d) Standard: Social worker. The facility must have a social worker who—
(1) Holds a master's degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education; or
(2) Has served at least 2 years as a social worker, 1 year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under §494.140(d)(1).
(e) Standard: Patient care dialysis technicians. Patient care dialysis technicians must—
(1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and
(2) Have a high school diploma or equivalency;
(3) Have completed a training program that is approved by the medical director and governing body, under the direction of a registered nurse, focused on the operation of kidney dialysis equipment and machines, providing direct patient care, and communication and interpersonal skills, including patient sensitivity training and care of difficult patients. The training program must include the following subjects:
(i) Principles of dialysis.
(ii) Care of patients with kidney failure, including interpersonal skills.
(iii) Dialysis procedures and documentation, including initiation, proper cannulation techniques, monitoring, and termination of dialysis.
(iv) Possible complications of dialysis.
(v) Water treatment and dialysate preparation.
(vi) Infection control.
(viii) Dialyzer reprocessing, if applicable.
(4) Be certified under a State certification program or a national commercially available certification program, as follows—
(i) For newly employed patient care technicians, within 18 months of being hired as a dialysis patient care technician; or
(ii) For patient care technicians employed on October 14, 2008, within 18 months after such date.
(f) Standard: Water treatment system technicians. Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body.
The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. Medical director responsibilities include, but are not limited to, the following:
(a) Quality assessment and performance improvement program.
(b) Staff education, training, and performance.
(c) Policies and procedures. The medical director must—
(1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; and
(2) Ensure that—
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; and
(ii) The interdisciplinary team adheres to the discharge and transfer policies and procedures specified in §494.180(f).
The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility.
(a) Standard: Protection of the patient's record. The dialysis facility must—
(1) Safeguard patient records against loss, destruction, or unauthorized use; and
(2) Keep confidential all information contained in the patient's record, except when release is authorized pursuant to one of the following:
(i) The transfer of the patient to another facility.
(ii) Certain exceptions provided for in the law.
(iii) Provisions allowed under third party payment contracts.
(iv) Approval by the patient.
(v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program.
(3) Obtaining written authorization from the patient or legal representative before releasing information that is not authorized by law.
(b) Standard: Completion of patient records and centralization of clinical information. (1) Current medical records and those of discharged patients must be completed promptly.
(2) All clinical information pertaining to a patient must be centralized in the patient's record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient's condition and prescribed treatment.
(3) The dialysis facility must complete, maintain, and monitor home care patients' records, including the records of patients who receive supplies and equipment from a durable medical equipment supplier.
(c) Standard: Record retention and preservation. In accordance with 45 CFR §164.530(j)(2), all patient records must be retained for 6 years from the date of the patient's discharge, transfer, or death.
(d) Standard: Transfer of patient record information. When a dialysis patient is transferred, the dialysis facility releasing the patient must send all requested medical record information to the receiving facility within 1 working day of the transfer.
The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients' personal and property rights, and to the general operation of the facility.
(a) Standard: Designating a chief executive officer or administrator. The governing body or designated person responsible must appoint an individual who serves as the dialysis facility's chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to—
(1) Staff appointments;
(2) Fiscal operations;
(3) The relationship with the ESRD networks; and
(4) Allocation of necessary staff and other resources for the facility's quality assessment and performance improvement program as described in §494.110.
(b) Standard: Adequate number of qualified and trained staff. The governing body or designated person responsible must ensure that—
(1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; and the registered nurse, social worker and dietitian members of the interdisciplinary team are available to meet patient clinical needs;
(2) A registered nurse, who is responsible for the nursing care provided, is present in the facility at all times that in-center dialysis patients are being treated;
(3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; and
(4) All employees have an opportunity for continuing education and related development activities.
(c) Standard: Medical staff appointments. The governing body—
(1) Is responsible for all medical staff appointments and credentialing in accordance with State law, including attending physicians, physician assistants, nurse practitioners, and clinical nurse specialists; and
(2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility's quality assessment and performance improvement program specified in §494.110.
(3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients.
(d) Standard: Furnishing services. The governing body is responsible for ensuring that the dialysis facility furnishes services directly on its main premises or on other premises that are contiguous with the main premises and are under the direction of the same professional staff and governing body as the main premises (except for services provided under §494.100).
(e) Standard: Internal grievance process. The facility's internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include:
(1) A clearly explained procedure for the submission of grievances.
(2) Timeframes for reviewing the grievance.
(3) A description of how the patient or the patient's designated representative will be informed of steps taken to resolve the grievance.
(f) Standard: Involuntary discharge and transfer policies and procedures. The governing body must ensure that all staff follow the facility's patient discharge and transfer policies and procedures. The medical director ensures that no patient is discharged or transferred from the facility unless—
(1) The patient or payer no longer reimburses the facility for the ordered services;
(2) The facility ceases to operate;
(3) The transfer is necessary for the patient's welfare because the facility can no longer meet the patient's documented medical needs; or
(4) The facility has reassessed the patient and determined that the patient's behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient's interdisciplinary team—
(i) Documents the reassessments, ongoing problem(s), and efforts made to resolve the problem(s), and enters this documentation into the patient's medical record;
(ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge;
(iii) Obtains a written physician's order that must be signed by both the medical director and the patient's attending physician concurring with the patient's discharge or transfer from the facility;
(iv) Contacts another facility, attempts to place the patient there, and documents that effort; and
(v) Notifies the State survey agency of the involuntary transfer or discharge.
(5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure.
(g) Standard: Emergency coverage. (1) The governing body is responsible for ensuring that the dialysis facility provides patients and staff with written instructions for obtaining emergency medical care.
(2) The dialysis facility must have available at the nursing/monitoring station, a roster with the names of physicians to be called for emergencies, when they can be called, and how they can be reached.
(3) The dialysis facility must have an agreement with a hospital that can provide inpatient care, routine and emergency dialysis and other hospital services, and emergency medical care which is available 24 hours a day, 7 days a week. The agreement must:
(i) Ensure that hospital services are available promptly to the dialysis facility's patients when needed.
(ii) Include reasonable assurances that patients from the dialysis facility are accepted and treated in emergencies.
(h) Standard: Furnishing data and information for ESRD program administration. Effective February 1, 2009, the dialysis facility must furnish data and information to CMS and at intervals as specified by the Secretary. This information is used in a national ESRD information system and in compilations relevant to program administration, including claims processing and reimbursement, quality improvement, and performance assessment. The data and information must—
(1) Be submitted at the intervals specified by the Secretary;
(2) Be submitted electronically in the format specified by the Secretary;
(3) Include, but not be limited to—
(i) Cost reports;
(ii) ESRD administrative forms;
(iii) Patient survival information; and
(iv) Existing ESRD clinical performance measures, and any future clinical performance standards developed in accordance with a voluntary consensus standards process identified by the Secretary.
(i) Standard: Relationship with the ESRD network. The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network's current statement of work. Each facility must participate in ESRD network activities and pursue network goals.
(j) Standard: Disclosure of ownership. In accordance with §420.200 through §420.206 of this chapter, the governing body must report ownership interests of 5 percent or more to its State survey agency.