Elite Dialysis

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 36734 Based on interview and observation, the facility failed to have documentation of an emergency preparedness plan in place. The findings included: An observation of binder titled Emergency Preparedness revealed the binder was empty. An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:30 PM. The FA stated they have not completed the emergency preparedness program binder. There was no evidence of an emergency preparedness plan in place.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have documentation of the emergency equipment’s daily checklist completed. The findings included: An observation of the facility’s emergency cart was conducted on 08/05/24 at 1:00 PM. The emergency equipment daily checklist was not completed for the month of 07/24. Further observation revealed the facility failed to have an emergency evacuation cart. An interview was conducted with the Facility Administrator on 08/05/24 at 1:30 PM. The FA acknowledged the above.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have emergency contact information for staff, and failed to have emergency contact information and treatment orders for patients. The findings included: An observation of the facility’s emergency evacuation cart revealed the cart was unsecured and empty. An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:30 PM. The FA acknowledged the above.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 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. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have a sanitary environment. The findings included: A tour of the facility was conducted on 08/05/24 at 12:00 PM. The hallway in front of the storage room was observed with stacks of cardboard boxes of supplies. Further observation revealed the facility’s supply room was also cluttered with stacks of cardboard boxes of supplies. An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:30 PM. The FA acknowledged the above.”

“H20 PURITY-ANSI/AAMI RD52:2004 CFR(s): 494.40(a) The facility must be able to demonstrate the following: 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, 75000 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, 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have documentation of water and equipment testing. The findings included: An observation of the facility’s water log binder revealed a lack of documentation for disinfection of water and dialysis machines. An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:00 PM. The FA acknowledged the above. The FA stated the disinfection logs were with the biomed tech, who was not available.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have documentation of water and equipment testing. The findings included: An observation of the facility’s water log binder revealed a lack of documentation for disinfection of water and dialysis machines. An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:00 PM. The FA acknowledged the above. The FA stated the disinfection logs were with the biomed tech, who was not available.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) 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. This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to have a prominently display of 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 findings included: A tour of the facility’s waiting room failed to display patient rights, as well as current State agency and ESRD network mailing addresses and telephone complaint numbers. An interview was conducted with the Facility Administrator (FA) conducted on 08/05/24 at 1:30 The FA acknowledged the above.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 36734 Based on record review and interview, the facility failed to documentation of immunizations for Patient #1. The findings included: Patient #1 was admitted to the facility on 08/05/24. A review of Patient #1’s record on 08/05/24 during treatment failed to reveal documentation of immunizations. An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:30 PM. The FA acknowledged the above.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) 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; This Standard is not met as evidenced by: 36734 Based on observation and interview, the facility failed to obtain a patient’s weight prior to dialysis (Patient #1). The findings included: Patient #1 was admitted to the facility on 08/05/24. Patient #1 was scheduled for Home Hemodialysis (HHD) training on 08/05/24. The facility failed to have a nurse available for HHD training. The facility proceeded with in-house Hemodialysis. The facility did not obtain a pre-dialysis weight. An interview conducted with Staff A, a Registered Nurse. Staff A stated the facility’s scale was broken and a weight could not be obtained.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) 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. This Standard is not met as evidenced by: 36734 Based on interview and record review, the facility failed to have a Social Worker available. The findings included: An interview was conducted with the Facility Administrator (FA) on 08/05/24 at 1:30 PM. The FA stated the facility did not have a Social Worker.”