Davita Falls Road Dialysis

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 36839 Based on review of the facility’s emergency preparedness (EP) plan and interviews with administrative staff, the facility’s governing body and the medical director failed to develop and implement a facility-based and community-based risk assessment, utilizing an all-hazards approach. This failure placed patients, staff and visitors at potential risk of harm in the event of an emergency situation. Findings included: End-stage renal disease (ESRD) facilities must complete the facility hazard vulnerability analysis tool for natural hazards in order to assess their susceptibility to potential risks and vulnerabilities posed by natural disasters specific to the facility’s location. This also ensures that proactive preparation and mitigation strategies are in place to safeguard the patients, staff, and the facility’s operations during emergencies. A review of the facilities EP plan on 3/13/2024 revealed no evidence of a documented facility hazard vulnerability analysis tool for natural hazards. This finding was confirmed by the facility’s administration during interview, and discussed during the exit conference on 3/13/2024.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) 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. This Standard is not met as evidenced by: 36839 Based on review of personnel files and interview with the facility administrator, the governing body failed to ensure that all clinical staff were screened for tuberculosis (TB) upon hire. This failure placed the patients, staff and visitors at potential risk for infection. Findings included: According to the Centers for Disease Control, all United States health care personnel should be screened for TB upon hire (i.e., preplacement). The local health department should be notified immediately if TB disease is suspected. Annual TB testing of health care personnel is not recommended unless there is a known exposure or ongoing transmission. Upon review of the personnel file on 3/13/2024, it was noted that Staff #11, who was hired at the facility on 11/27/2023, did not have any record showing that he/she was screened for TB. This finding was confirmed by the facility administrator and the manager of clinical services on 3/1/3/2024.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And 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; This Standard is not met as evidenced by: 36839 Based on infection control observations, the governing body failed to ensure that all clinical staff followed safe practices when handling infectious wastes. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Findings included: The Occupational Health and Safety Administration (OSHA): 29CFR1910.1030(d)(2)(xi)states: “All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Carrying a contaminated blood tubing and dialyzer from the patient’s station across the treatment floor to a biohazard box could result in unknown spattering of blood. Therefore, if an employee carries contaminated dialysis tubing and dialyzer from a patient’s station, at the end of treatment, to the biohazard box that is located across the treatment floor, this could result in a blood splatter. During observations in the clinical treatment room on 3/12/2024, it was noted that Staff #5 removed the blood tubings and dialyzer from the dialysis machine at the end of a patient’s dialysis treatment and walked approximately 10 feet to the biohazard trash to discard the contaminated supplies. This finding was discussed with the facility administrator and the manager of clinical services during the exit conference on 3/13/2024.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 36839 Based on review of the dialysis machine disinfection logs and a review of the facility’s policies and procedures, the governing body failed to ensure that the clinical staff followed standard infection control practices. This failure placed all patients and staff at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings included: To prevent the transmission of infectious diseases, healthcare facilities must follow strict policies and procedures for cleaning and disinfecting dialysis machines. These policies and procedures should be based on the guidelines set forth by regulatory agencies such as the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). According to the facility’s policy (7-05-16, page 1, #2), “All dialysis delivery systems, including backup dialysis delivery systems intended for patient use, are routinely required to be disinfected at no more than 48 hour interval.” Upon review of the facility’s disinfection logs on 3/12/2024, no documentation was found showing that all 15 dialysis machines used for their patients were cleaned and disinfected at the end of the day on 2/17/2024. This finding was verified and discussed with the facility administrator and the manager of clinical services during the exit conference on 3/13/2024.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) 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. This Standard is not met as evidenced by: 36839 Based on observations in the clinical treatment room, the governing body failed to maintain the facility in a manner that ensured the integrity of all surfaces were kept intact, clean and free of damage. This failure increased the risk of ineffective cleaning, and the potential for unseen microbial growth and safety issues. Findings included: A dialysis facility has to be maintained free from defects and hazards in order to ensure safety and functionality. The integrity of all surfaces must be intact, clean and free from damage to allow for adequate cleaning and disinfection in order to prevent the spread and growth of microbial organisms. During observations in the patients’ treatment room on 3/12/2024, the following were noted which were indicative of lack of regular and proper cleaning: 1. The right faucet knob of the dirty sink across station #5 was surrounded by a yellowish substance. 2. The left and right faucet knobs of the dirty sink facing station #11 was surrounded by blue, black, and white crystallized substances. 3. A 3-tier cart located across station #5 had white and crystallized substances on the surface. 4. A 3-tier cart located across station #11 had white and crystallized substances on the surface. These findings were discussed with the facility’s administrative team during the exit conference on 3/13/2024.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(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 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 36839 Based on patient record review, the governing body and the interdisciplinary team (IDT) failed to ensure that a Plan of Care (PoC) has been conducted on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patient #5 Findings included: The Centers for Medicare and Medicaid Services (CMS) require a PoC to be completed for each new dialysis patient within 30 days or 13 treatments, whichever comes first, starting from the first dialysis session. The purpose of this assessment is to provide a comprehensive evaluation of the patient’s physical, psychosocial, and medical status, which is used to develop an individualized care plan for the patient. A review of the sampled patients’ medical records on 3/13/2024 showed that Patient #5’s first dialysis treatment at the facility was on 12/14/2022; however, the initial PoC was done on 2/27/2023 which was greater than 30 days from the patient’s first dialysis session. This finding was discussed with the administrative team during the exit conference on 3/13/2024.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) 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; This Standard is not met as evidenced by: 36839 Based on review of patients’ plans of care (POC), the governing body failed to ensure that the facility’s interdisciplinary team (IDT) completed the comprehensive reassessment of stable patients on an annual basis. This failure placed the affected patients at risk for receiving inadequate health care and denied the patients their rights. Patient #3 Findings included: As per the Centers for Medicare and Medicaid Services (CMS) guidelines, every stable patient must undergo a thorough annual reassessment. The initial annual review is expected either 12 months after the 3-month reassessment or 15 months following admission to the facility. While annual reassessments are the required minimum, more frequent reassessments of stable patients may be done as needed based on facility policies or clinical considerations. The facility’s policy (1-14-01, page 2, #7) states, “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: · At least annually for stable patients · At least monthly for unstable patients including, but not limited to, patients with the following: · Extended or frequent hospitalizations · Marked deterioration in health status · Significant changes in psychosocial needs · Concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis” Upon review of the sampled patients’ PoCs on 3/13/2024, it was noted that Patient #3 had an initial hemodialysis treatment at the facility on 6/17/2021. The patient’s first annual PoC was done on 9/7/2021 and the second annual PoC was done on 8/30/2022; however, the third annual PoC was done on 10/3/2023 which was greater than 12 months from the previous PoC. This finding was discussed with the facility administrator and the manager of clinical services during the exit conference on 3/13/2024.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 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. This Standard is not met as evidenced by: 36839 Based on review of the facility’s personnel files, the governing body failed to ensure that all clinical staff had current completion of the annual written and skills checklist competencies. This failure denied the patients their rights to receive competent care from the clinical staff, and placed the patients at potential risk of harm. Findings included:. Personnel files should include annual competence review and applicable retraining. Each person performing procedures within the end-stage renal disease (ESRD) unit shall have successfully completed the dialysis facility’s training course relevant to that person’s task and demonstrated competence in the area covered by his or her training. Annual review of competence is required with appropriate retraining if deficiencies are found. A review of the facility’s personnel file provided by the facility administrator on 3/13/2024 revealed the following: 1. Out of 12 clinical staff members, 6 (50%) patient care technicians (PCT) did not have any record of annual competencies. (Staff #5, #6, #7, #8, #9 and #10). 2. Staff #11, who was hired on 11/27/2023, had no record of emergency procedures and infection control training. These findings were confirmed by the facility administrator and the manager of clinical services, and discussed during the exit conference on 3/13/2024.”