St. Pete Dialysis/ Central Dialysis

“ADDITIVES-MIXING SPIKES CFR(s): 494.40(a) 5.4.5 Additives: mixing spikes Concentrate additives should be mixed with liquid acid concentrates according to the manufacturer’s instructions, taking care to ensure that the additive is formulated for use in concentrates of the appropriate dilution ratio. When liquid additives are used, the volume contributed by the additive should be considered when calculating the effect of dilution on the concentration of the other components in the resulting concentrate. When powder additives are used, care should be taken to ensure that the additive is completely dissolved and mixed before the concentrate is used. This Standard is not met as evidenced by: 42154 Based on facility policy, observation, and interview the facility failed to properly label acid jug in one of one observed. Findings included: On 3/21/2025 at 08:15AM an acid jug (Acid concentrate is an essential component in the preparation of dialysis fluid) was located on Machine #7 at Station number 12 being used for dialysis on Patient # 4. The acid jug was labeled with a manufacturer label of 2.0 K/potassium and 2.0 Ca/Calcium. In black marker scribed on the container was 2.0 K/potassium & 3.5 Calcium. There was another marking with black marker showing 2.0 Calcium and 3.5 K potassium, initials were noted on the container and dated for 3/21/2025. During an interview on 3/21/2025 at 08:15AM, concurrent with the observation with Staff B, RN (Reigstered Nurse) he stated, “Its labeled correctly above.” Photographic evidence obtained.”

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 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. This Standard is not met as evidenced by: 42154 Based on an observation and an interview, the facility failed to ensure patient care supplies were not expired in 6 of 6 expired blood vials observed. Using expired blood collection vials can affect the results of patient bloodwork and plan for treatment. Findings included: On 3/21/2025 at 08:35 AM while touring the facility supply room and laboratory area, 6 expired lab vials were noted in the storage area. The expiration date from oldest 04/06/2022 to 03/01/2025. During an interview on 03/21/2025 at approximately 12:30 PM with Staff H, Medical Doctor regarding the expired tubes and he stated, “Did you find it on the top of the cabinet, because we have not gone through there yet.” Photographic evidence obtained.”

“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: 49691 Based on the facilities Emergency Preparedness binder, interviews, and medical records the facility failed to review and update the emergency preparedness program biannually in 1 of 1 Emergency Preparedness Program. Findings included: Review of the Emergency Preparedness binder shows it was last reviewed in 5/2021. Review of the facility policies revealed the facility had no policy on Emergency Preparedness. During and interview on 02/13/2025 at 10:00 AM with the Medical Director and DON (Director of Nursing), The Medical Director stated that the Social Worker does all of the Emergency Preparedness, he had all the data that you need for “cut and clamp” and fire drills. The Social Worker was not available at that time. Review of 4 medical records revealed there was no education noted for fire drills or cut and clamp in case of emergency.”

“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: 49691 Based on review of the facility Emergency Preparedness Binder, Florida ESRD Network 7 standard of care, and interviews, the facility failed to develop an Emergency Preparedness plan based on an all-hazards approach identified by the facility risk assessment. Findings included: Review of the Emergency Preparedness binder shows it was last reviewed in 5/2021. The last risk assessment was conducted in 2021. The DI (Deionization) contract for temporary RO (reverse osmosis) for use in emergencies last contracted 2021. The contract stated good for 1 year. Review of the facility policies revealed the facility had no policy on Emergency Preparedness. Review of The Florida ESRD (End Stage Renal Disease) Network (Network 7) Clinical Performance Guidelines and Standards of Care for Florida Dialysis Facilities dated 2018 accessed at https://www.hsag.com/globalassets/esrd/clinical-standards/nw7perfguidelinesstandardscare.pdf on 2/14/2025 reveals All Medicare-certified ESRD providers shall have written policies and procedures that specifically define the handling of emergencies which may threaten the health and safety of patients. Such emergencies would exist during natural disaster (e.g., fire or hurricane) or during functional failures in equipment or utilities. Specific emergency preparedness procedures exist for different kinds of emergencies. At a minimum, the provider shall: · Review and test the emergency preparedness plan, at least annually, and revise as necessary. · Ensure all personnel are knowledgeable and trained in their respective roles in emergency situations. · Ensure the availability of emergency medications, medical supplies, and equipment. · Ensure that staff are familiar with the use of all dialysis equipment and procedures to handle medical emergencies. · Ensure that patients are trained to handle medical and non-medical emergencies. - Patients must be fully informed regarding what to do, where to go, and who to contact if a medical or non-medical emergency occurs. During an interview on 02/13/2025 at 10:00AM with the Medical Director and DON (Director of Nursing), The Medical Director stated that the Social Worker does all of the Emergency Preparedness, he has all the data that you need for “cut and clamp” and fire drills. The Social Worker was not available at that time.”

“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: 49691 Based on facility documents, standards of care, observations, and interviews the facility failed to provide and monitor a sanitary environment on 2 (2/12/25, 2/13/25) of 2 survey days. Findings included: Review of the Infection Control Surveillance and Reporting Monitoring Tool provided by the Facility, states 1. Personal Protective Euipment (PPE) including gloves, mask, protective eye war or face shields and gowns are readily available and worn when appropriate according to established protocols. Review of facility policies revealed there was no policy on sanitary environment or minimizing transmission of infectious agents. Review of Donning and Doffing PPE: Proper Wearing, Removal, and Disposal accessed at https://www.cdc.gov/niosh/learning/safetyculturehc/module-3/8.html on 02/26/2025 revealed Donning means to put on and use PPE properly to achieve the intended protection and minimize the risk of exposure... Remove PPE before entering any non-clinical areas including restrooms, breakrooms, and administrative areas. On 02/12/2025 at 10:30 AM Staff B, LPN (License Practical Nurse) left the unit in personnel protective equipment (PPE) gown without performing hand hygiene. She then walked down the hall, out of sight, and then returned to the unit, and left again. On 02/12/2025 at 2:08 PM Staff A, CCHT (Certified clinical hemodialysis technician) left the dialysis unit in a PPE gown to the staff lounge and get ice for a patient. Staff A, CCHT left the unit a total of 3 times with the gown on and without performing hand hygiene. On 02/12/2025 at 12:23 PM Staff F, CCHT discontinued a left upper extremity AV (arteriovenous) graft on patient #1. Staff F, CCHT disconnected bloodlines and changed her gloves. no hand hygiene was performed. Staff F, CCHT documented in the computer, with the gloves still on and then moved to get a rolling chair to sit in. Staff F then picked up a pen and wrote on clip board. Staff F, CCHT removed the needles from the patient’s arm; she had the patient apply pressure to the arm before removing gloves and performing hand hygiene. During an interview on 02/13/2025 at 11:00 AM Staff E, Facility Administrator/ Director of Nursing stated, “They know that they cannot leave the unit in their gowns, we should put up a sign not to leave the unit with your gown on and to hang it up on the hooks before exiting, the sink is right there before you exit the unit”.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 42154 Based on CDC (Centers for Disease Control and Prevention) guidelines, observations and interviews, the facility failed to ensure that hand hygiene was performed in 3 of 3 observations. Findings included: Review of Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients accessed at https://www.cdc.gov/infection-control/hcp/dialysis-infections/index.html on 2/26/2025 revealed ...In the hemodialysis setting, contact transmission plays a major role in transmission of bloodborne pathogens. If a health-care worker ’ s hands become contaminated with virus-infected blood from one patient, the worker can transfer the virus to a second patient’s skin or blood line access port, and the virus can be inoculated into that patient when the skin or access port is punctured with a needle. Contact transmission can be prevented by hand hygiene (i.e., hand washing or use of a waterless hand rub), glove use, and disinfection of environmental surfaces. Review of facility policies revealed there was no policy on hand hygiene or Personal Protective Equipment (PPE). On 02/12/2025 at 10:30 AM Observed Staff B, LPN (Licensed Practical Nurse) leave the hemodialysis area wearing personnel protective equipment (PPE) gown without performing hand hygiene. She then walked down the hall, out into the doctor’s office area, and returned to the patient care area, and left again without performing hand hygiene or removal of PPE gown. On 02/12/2025 at 12:23 PM Staff F, CCHT (Certified Clinical Hemodialysis Technician) discontinued a left upper extremity AV (arteriovenous) graft on patient #1. Staff F, CCHT disconnected bloodlines and changed her gloves. No hand hygiene was performed. Staff F, CCHT documented in the computer, with the gloves still on and then moved to get a rolling chair to sit in. Staff F then picked up a pen and wrote on clip board. Staff F, CCHT removed the needles from the patient ’ s arm; she had the patient apply pressure to the arm before removing gloves and performing hand hygiene. On 02/12/2025 at 2:08 PM Staff A, CCHT left the dialysis unit in a PPE (Personal Protective Equipment) gown to the staff lounge and get ice for a patient. Staff A, CCHT left the unit a total of 3 times with the gown on and without performing hand hygiene. During an interview on 02/13/2025 at 11:00 AM Staff E, Facility Administrator/ Director of Nursing stated, They know that they cannot leave the unit in their gowns, we should put up a sign not to leave the unit with your gown on and to hang it up on the hooks before exiting, the sink is right there before you exit the unit. All you need to do is hang up your gown and wash your hands.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 42154 Based on CDC guidelines, observation, and interviews the facility failed to follow the standard of care in PPE (Personal Protective Equipment) usage in 4 (Staff A, B, C, F) of the 5 staff observed. Findings included: Review of CDC (Centers for Disease Control and Prevention) Guidelines, “Standard Precautions for All Patient Care”, accessed on 02/14/2025 at https://www.cdc.gov/infection-control/hcp/basics/standard-precautions.html shows .......personal protective equipment use that protect healthcare providers from infection and prevent the spread of infections from patient to patient ... Use Personal Protective Equipment (PPE) whenever there is an expectation of possible exposure to an infectious material ... Review of the facility policies revealed that there was no policy on use of PPE. Review of the Infection Control Surveillance and Reporting Monitoring Tool provided by the Facility, states 1. Personal Protective Equipment (PPE) including gloves, mask, protective eye war or face shields and gowns are readily available and worn when appropriate according to established protocols. During observation on 2/12/25 between 8:15 AM -10:15 AM Staff A, CCHT (Certified Clinical Hemodialysis Technician), Staff F, CCHT and Staff C, RN were not wearing protective eye wear. During observation on 2/12/25 between 10:15 AM - 4:30 PM Staff A, CCHT, Staff F, CCHT and Staff C, RN applied PPE protective equipment as headbands on their heads, improperly covering their eyes, while placing patients on hemodialysis. During an interview on 2/12/2025 at approximately 10:15 AM with Staff C, RN (Registered Nurse) regarding utilization of Face Shields or eye goggles, he stated, “I’m wearing [prescription] glasses” and stated we do not have them available.”

“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: 49691 Based on observations, and staff interviews, the facility did not ensure the patient Dialysis treatment area was free from spread of potentially infectious waste by failing to secure open acid jugs leaving the fluid open to the elements, in 3 of 3 acid jug containers (Dialysis acid jugs contain a concentrate of acid that is used to mix with bicarbonate to create dialysate. Findings Inlcuded: On 02/12/2025 at 9:00 AM, an Acid jug sitting on the bottom of the Station #15 dialysis machine with the lid not secured. Dialysis acid jugs contain a concentrate of acid that is used to mix with bicarbonate to create dialysate. On 02/12/2025 at 11:30 AM observation of Staff F, CCHT (Certified Clinical Hemodialysis Technician) at station #3. There was an acid jug at the dialysis station that was not secured with a tight-fitting cap. On 02/12/2025 at 1:13 PM Staff, F CCHT set up station #7 with an acid jug not secured prior to starting patient on dialysis treatment. During an interview on 02/12/2025 at 9:30 AM with Staff C, RN (Registered Nurse) the unsecured lid to the acid jug was shown to him and it was fixed, and he stated, “I already told her that it had to be secure”. During an interview on 02/12/2025 at 11:35 PM with Staff C, RN it was noted that Staff A, CCHT at station #15 had an acid jug that had an unsecure lid. He said nothing and delegated Staff H, CCHT to fix the jug. Photo evidence obtained. Based on observations, and staff interviews, the facility did not ensure the patient Dialysis treatment area was free from spread of potentially infectious waste in 1 of 1 day of observation. On 02/12/2025 at 9:00 AM the dialysis unit was noted to have clean sterile supplies on the nursing station next to the biohazard bin and garbage can with 2 patient wheelchairs and a walker in front of the biohazard bins. A used Acid jug with the patients name on it from station #15 was placed on the nurse’s station next to clean supplies ready for incoming dialysis patients. During an interview on 02/13/2025 at approximately 11:30AM with Staff F, Facility administrator / Director of Nursing , she was informed of the used acid jug sitting on the nursing station and shown the photo evidence and she stated, “They should not write the patient name on it, and they must wipe it down, but yes it should not be placed on the nursing station next to the sterile supplies”. Photographic evidence was obtained.”

“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: 42154 Based on Standards of Care, Observation, and interviews, the facility failed to properly disinfect a station between patients care in one of two observations. Findings included: Review of Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients accessed at https://www.cdc.gov/infection-control/hcp/dialysis-infections/index.html on 2/26/2025 revealed ... Cleaning and Disinfection ... After each patient treatment, clean environmental surfaces at the dialysis station, including the dialysis bed or chair, countertops, and external surfaces of the dialysis machine, including containers associated with the prime waste. On 02/12/2025 at 9:41 AM Staff A, CCHT (Certified Clinical Hemodialysis Technician started to clean station #6. She removed all blood lines and discarded them in the biohazard waste receptacle. Staff, A CCHT left the station to attend to a patient. She returned to station #6 at 10:19 AM with new supplies for another patient without cleaning and disinfecting the station. During an interview on 02/12/2025 at 10:22 AM Staff A, CCHT stated that the station was already cleaned by Staff F, CCHT. Staff A, CCHT asked Staff F, CCHT and the station had not been cleaned. During an interview on 02/12/2025 at 10:25 AM Staff C, RN stated, “the stations must be cleaned prior to bringing supplies for another patient there.””

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 49691 Based on waterlog record reviews, observations and interviews, the facility failed to ensure accurate timing and documentation of chloramines testing in 1 of the 3 tests Observed. Findings included: Review of facility policies revealed there was no policy on water testing. A review of the RO (Reverse Osmosis) log, which includes chloramine (Chloramines are a disinfectant that can contaminate dialysis water and harm patients. They are toxic and must be removed from water used in dialysis machines) checks, revealed that the recorded times noted on the chloramine checks were precisely every 4 hours starting at 5:00AM, 9:00AM, 1:00PM, and 5:00PM every Monday, Wednesday and Friday. On 2/12/2025 at 1:01PM an observation was performed of Staff A, CCHT (Certified Clinical Hemodialysis Technician) conducting Chloramine checks in the Reverse Osmosis room. The test occurred at 1:16PM, which was 16 minutes over the allotted 4-hour timeframe from the last chloramine check. When staff A, CCHT recorded the task, they wrote in the log the results noting the time as 1:00PM. In an interview with the Director of Nursing (DON) on 02/13/2025 at 10:38AM, the DON stated there is no alarm to remind Staff to do chloramine checks, they would obtain one.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) 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. This Standard is not met as evidenced by: 49691 Based on observation and interview the facility failed to ensure that independent pH and conductivity testing was performed in 3 (Staff A, C, F) of 3 Staff during patient dialysis shifts machine turnovers. Findings included: Review of the facility policies revealed there was no formal policy on performing independent verification of pH and Conductivity on the Hemodialysis Machines. During an observation on 2/12/25 at approximately 10:45 AM Staff A, CCHT (Certified Clinical Hemodialysis Technician) Staff C, RN (Registered Nurse) and Staff F, CCHT prepared dialysis machines for incoming dialysis patients. Independent verification of pH (logarithmic scale used to specify the acidity or basicity of aqueous solutions) strips and conductivity (The degree of which a specific material conducts electricity) of the dialysate on the hemodialysis machines was not conducted by staff members. pH and conductivity meter noted to be in storage at the nursing station, without being accessed by the team members. During an interview on 2/12/2025 at 11:20. When asked when they perform these required tests Staff C, RN said “once the machine is set up.””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(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. This Standard is not met as evidenced by: 42154 Based on facility documents, and interviews the facility failed to evaluate and analyze trends in the cause of death in dialysis patients in 6 deaths in 4 months. Findings included: Review of the policy, Quality Assurance and Quality Improvement Plan, undated revealed the Quality Assurance Program will define problem areas, solutions, corrections taken, and follow-up as well as monitor policy and procedures with emphasis on staff performance. The Goal is also to ensure policy and procedures are done according to standards set by the Governing Body of Central Dialysis Center. Review of the Quality Assurance Performance improvement meeting minutes in September 2024 one death, October 2024 1 death, November 2024 1 death, and December 2024 3 deaths. No evidence that the mortalities were evaluated or analyzed to determine if a trend exists. The facility was unable to provide evidence of which patients had expired or that an investigation/determination of death was identified. Review of meeting minutes provided for July 2024 to December of 2024 revealed no identification of areas of concerns, no tracking or trending to improve outcomes of quality of patient care. During review of meeting minutes provided on 2/13/2025 at 10:00 AM with the Medical Director and DON (Director of Nursing) the MD (Medical Director/Medical Doctor) stated he has to sign the death certificates and puts cause of death, but they died in the hospital. During an interview on 02/13/2025 at 10:00 AM with Staff E Facility Administrator/ Director of Nursing stated, “we talk about the mortalities, but I do not have anything to show that we do.””

“PQ-NURSE MANAGER-12 MO RN+6 MO DIALYSIS CFR(s): 494.140(b)(1) (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. This Standard is not met as evidenced by: 42154 Based on observations, personnel file and interviews the facility failed to have a Nurse Manager with 6 months of experience in providing nursing care to patients on maintenance dialysis with oversight of the dialysis unit during patient treatments in 1of 1 Charge Nuse. Findings included: Review of the Staff C, Charge RN (Registered Nurse) personnel file, revealed Staff C began training and orientation in Dialysis in January of 2025 and had not completed orientation. Staff C, RN (Registered Nurse) was the only RN and charge nurse within the facility on 2/12/2025. On 2/13/2025 interview with the administrator and Physician when asked about the current charge nurses lack of experience they responded that the “regular” Charge nurse was coming back from FMLA next week who has dialysis experience. The physician also stated that it has been difficult finding experienced staff, and the costs were high. During an interview on 02/13/2025 at 8:56 AM with Staff E Facility Administrator/ DON (Director of Nursing), she stated, “I can’t be here Monday, Wednesday, or Friday. I come every week on Tuesday to assist with the Quality Assessment Performance Improvement (QAPI).” She also stated that Staff D Medical Director is here every day during dialysis seeing patients in his [attached] office.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 42154 Based on the facility policy binders, Facility Quality Assessment Performance Improvement plan and interviews it was determined the facility did not have an appropriate policies in place for an in-center dialysis unit. Findings included: Review of the Quality Assurance and Quality Improvement Plan ...B. Quality Assurance Purpose and Goals: The facility has established a quality assurance program to review quality of patient care, regulations and operations of the facility ...the goal is also to ensure policy and procedures are done according to stands set by the Governing body ... Review of the facility two policy binders revealed that there was no date when the policies were reviewed, and numerous policies not related to an in-center dialysis unit. During an interview on 02/13/2025 at 11:30 AM Staff D, Medical Director stated, “those policies are from a dialysis center that I went to before we opened and I took them for this unit, we were thinking about doing home dialysis but chose not to.””