Seminole Dialysis Center

“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: 20536 Based on facility record review and staff interview, it was found the facility failed to ensure it’s Emergency Preparedness Plan was reviewed by management annually, and had not been reviewed and approved for a period of two years. Findings included: On 5/28/2024 9:20 a.m., an interview with the facility’s Administrative Assistant (AA), Staff A, revealed the facility has gone through a management change and currently a Facility Administrator (FA) Staff B, assists this facility as well as another facility located in another county. Staff A revealed they have not had a dedicated Clinical Manager (CM), or FA for months and receives assistance from other FAs and Directors of Operations (DO). Staff A revealed the facility does have an Emergency Preparedness program and plan, but she was not sure if it had been reviewed annually by management. Staff A. confirmed she could not find the Emergency Preparedness Plan for the years 2023 and 2024. On 5/28/2024 at 10:30 a.m. an interview with the interim FA, Staff B, revealed she has been working at this facility as well as another facility in another county for a couple of months now, but was not able to find evidence that the Emergency Preparedness plan was available to be reviewed by this surveyor. She revealed there should be one but could not find it. On 5/28/2024 at 10:40 a.m. an interview with the incoming FA, Staff C, revealed she would look for the past Emergency Preparedness plan. Further interview with Staff C, revealed she has been working some at this facility, but her original start date to take over FA responsibilities was not until 6/10/2024. On 5/29/2024 at 9:00 a.m. the facility’s Emergency Preparedness Plan was reviewed with Staff C. Upon review of the Emergency Preparedness Plan book, and confirmed with Staff C, there was no evidence the plan was reviewed for the entire year of 2023. Staff C revealed that she had been working on the plan prior to her hire date and usually the plans are reviewed late April, beginning of May. She confirmed there was no evidence of a reviewed plan by management since 2022. The facility did not have a policy and procedure related to expectations of when the Emergency Preparedness Plan was to be reviewed.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff 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. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 20536 Based on staff interview and employee record review, the facility failed to ensure one of three (Staff K) sampled employees reviewed, received training in emergency preparedness upon his hire date and within the last two years. Findings included: On 5/29/2024 Staff G, a Regional Director of Operations, provided personnel files with training and education for review. Staff G was not a permanent employee at this facility, but was sent to assist with the survey inspection. Upon review of the employee files the following was revealed: 1. Staff K, who was a Registered Nurse and a permanent employee at the facility, was noted with a hire date of 2/23/2009. Review of the provided “ESRD CORE Survey Facility Worksheet: Personnel File”, revealed “N/A” under the Emergency Procedures, Infection Control Training section. Further interview with Staff G confirmed she could not find any Emergency Preparedness training/education upon his hire date, nor within the last two years. Staff G revealed she was not a permanent member of this facility but had also communicated with staff development/human resources and they could not find this completed training either. Staff G confirmed there was no evidence to show Staff K was current with this training. On 5/29/2024 at 11:00 a.m. an interview with the interim Facility Administrator (FA), Staff B, revealed she had only been the interim FA for a couple months filling in until a permanent FA could be hired. Staff B also confirmed she could not provide evidence that Staff K had ever received Emergency Preparedness training either upon his hire date and within the last two years. On 5/29/2024 at 11:20 a.m. an interview with the incoming FA, Staff C, revealed she has been somewhat working at the facility recently but her original hire date is not until 6/10/2024. She too confirmed she was not able to provide any evidence that Staff K had ever completed Emergency Preparedness training upon his hire date and within the last two years. Both Staff B and C were not able to provide a policy and procedure related to training requirements for Emergency Preparedness.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 20536 Based on staff interview and employee record review, the facility failed to ensure one of three (Staff K) sampled employees reviewed and received training in Infection Control practices upon hire. Findings included: On 5/29/2024 Staff G, a regional Director of Operations, provided personnel files with training and education for review. Staff G was not a permanent employee at this facility, but was sent to assist with the survey inspection. Upon review of the employee files the following was revealed: 1. Staff K, who was a Registered Nurse and a permanent employee at the facility, was noted with a hire date of 2/23/2009. Review of the provided “ESRD CORE Survey Facility Worksheet: Personnel File”, revealed “N/A” under Emergency Procedures and Infection Control Training section. Further interview with Staff G confirmed she could not find any Infection Control training/education upon his hire date, nor within the last two years. Staff G revealed she was not a permanent member of this facility but had also communicated with staff development/human resources and they could not find this completed training either. Staff G confirmed there was no evidence to show Staff K was current with this training. On 5/29/2024 at 11:00 a.m. an interview with the interim Facility Administrator (FA), Staff B, revealed she had only been the interim FA for a couple months filling in until a permanent FA could be hired. Staff B also confirmed she could not provide evidence that Staff K had ever received Infection Control training either upon his hire date or within the last two years. On 5/29/2024 at 11:20 a.m. an interview with the incoming FA, Staff C, revealed she has been somewhat working at the facility recently but her original hire date is not until 6/10/2024. She too confirmed she was not able to provide any evidence that Staff K had ever received or completed Infection Control training upon his hire date and within the last two years. Both Staff B and C were not able to provide a policy and procedure related to training requirements for Infection Control training.”

“IC-MONITOR CATH-RELATED BSI RATES/SURV CFR(s): 494.30(a)(2) Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. I. Surveillance A. Conduct surveillance ...to determine CRBSI rates, monitor trends in those rates, and assist in identifying lapses in infection-control practices. C. Investigate events leading to unexpected life-threatening or fatal outcomes. This includes any process variation for which a recurrence would likely present an adverse outcome. This Standard is not met as evidenced by: 20536 Based on facility documentation, medical records, and interview, the facility failed to report infections to the dialysis module of the national healthcare safety network and conduct surveillance on infections in two (2 and 4) out of ten sampled patients. Findings included: Review of Patient #2’s medical record shows patient was admitted to the hospital with sepsis (a life threatening complication of an infection, occurs when chemical s released in the blood stream to fight an infection trigger inflammation throughout the body- MAYOCLINIC.COM) and fever on 08/21/2023, on 08/25/2023 patient expired. Review of Patient #4’s medical record shows patient was admitted to the hospital and expired on 01/31/2024 with a cause of death of severe endocarditis (an infection of the heart’s inner lining usually involving the heart valves, it occurs when germs from elsewhere in the body travel through the blood and attach to damaged areas of the heart- MAYOCLINIC.COM). Review of the facility document to report to the National Healthcare Safety Network (NHSN) revealed the facility failed to report patients #2 and #4’s infections. No evidence of surveillance for catheter related infections was provided from the facility after requests on 05/28/2024 and on 05/29/2024. During an interview on 05/28/2024 at 12:43 PM with Staff F, Director of Operations, revealed that the corporate leadership reports to NHSN for infection and they get the information from the dashboard of each facility that is triggered when an employee puts in the patient medical record that the patient is on antibiotics. Staff F did not respond on why these patients are not listed. Staff F stated that the facility did not investigate the deaths of patients #2 and #4. An interview was conducted with staff C, Facility Administrator (FA), on 05/29/2024 at 11:58 AM. Staff C stated that the Equip (facility Electron medical record) did not cross over to the Quality assessment and that is why the mortality and infection is not being tracked and trended with the four patients that have expired. An interview was conducted with staff G, Director of Quality, on 05/29/2024 at 12:29 PM. Staff G stated that major changes had occurred in this facility, and that unfortunately this center has had no manager and no leadership, and things have been missed because of this.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 20536 Based on observations, record review, and interviews, the facility failed to ensure that monitoring of pH and conductivity (Measure of a solutions ability to conduct electricity) was conducted with an independent method before starting a treatment of a patient (2 of 2 observations). Failure to ensure independent verification of the dialysis machine’s conductivity may come out of range causing the machine to be in bypass mode, resulting in dialysis machine not removing toxins and fluid. Findings Included: The observation occurred after observing the complete dialysis machine set up and preparation for the treatment of the patient. On 05/28/2024 at 10:09 AM observed and heard an alarm for chair 15 and 16 with Bicarb Cond low. Chair 16 alarm was corrected at 10:32 AM and chair 15 the staff changed the machine at 10:58 AM Based on an observation on 5/28/2024 @ 10:45 observed Staff J at Dialysis Station #7 complete a dialysis treatment set up and preparation to initiate a dialysis treatment without performing an independent verification of the pH and conductivity. On 05/28/2024 at 10:09 AM observed and heard an alarm for chair 15 and 16 with Bicarb Cond low. Chair 16 alarm was corrected at 10:32 AM and chair 15 the staff changed the machine at 10:58 AM. Based on an observation on 5/29/2024 @ 10:10 a.m. observed Staff J at Dialysis station #14 initiate a dialysis treatment of a patient, without independent verification of pH and conductivity. In an interview with the Facility Administrator on 5/28/2024 at 11:34 a.m. a discussion regarding the dialysis machines alarms it was brought to her attention that the machines were alarming for 30 minutes and that we noted that in our observations there wasn’t any independent verification of the pH and conductivity for the dialysis machines performed by the dialysis staff and she shook her head. Interview with Staff F RN Director of operations on 05/28/2024 at 12:43 PM where she stated that she is going to be transparent, and she did identify that the alarms were going off for over 30 minutes. Review of Fresenius Policy 47798/Titled Pretreatment Safety Check procedure; Regarding pretreatment safety checks and procedures specify that, “Staff must test the dialysate pH using a different independent method, such as a handheld meter or pH strip.” Review of the Daily Phoenix meter calibration logs over a 2-month record including the dates of the observations noted, the Phoenix meter machines that are used in the facility for the purpose of verifying pH and conductivity were calibrated and ready for use for but were not used for independent verification.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 20536 Based on staff interview and employee record review, the facility failed to ensure one of three (Staff K) sampled employees reviewed received training in Water and Dialysate practices upon hire. Findings included: On 5/29/2024 Staff G, a regional Director of Operations, provided personnel files with training and education for review. Staff G was not a permanent employee at this facility, but was sent to assist with the survey inspection. Upon review of the employee files the following was revealed: 1. Staff K, who was a Registered Nurse and a permanent employee at the facility, was noted with a hire date of 2/23/2009. Review of the provided “ESRD CORE Survey Facility Worksheet: Personnel File”, revealed “N/A” under Water Dialysate, Machine, Reuse section. Further interview with Staff G confirmed she could not find any Water Dialysate and Water training/education upon his hire date, nor within the last two years. Staff G revealed she was not a permanent member of this facility but had also communicated with staff development/human resources and they could not find this completed training either. Staff G confirmed there was no evidence to show Staff K was current with this training. On 5/29/2024 at 11:00 a.m. an interview with the interim Facility Administrator (FA), Staff B, revealed she had only been the interim FA for a couple months filling in until a permanent FA could be hired. Staff B also confirmed she could not provide evidence that Staff K had ever received Water and Dialysate, Machine use, and Reuse training either upon his hire date and within the last two years. On 5/29/2024 at 11:20 a.m. an interview with the incoming FA, Staff C, revealed she has been somewhat working at the facility recently but her original hire date is not until 6/10/2024. She too confirmed she was not able to provide any evidence that Staff K had ever received and completed Water and Dialysate, Machine use, and Reuse training upon his hire date and within the last two years. Both Staff B and C were not able to provide a policy and procedure related to training requirements for Water and Dialysate, Machine use, and Reuse.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (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. This Standard is not met as evidenced by: 20536 Based on medical records, facility documentation, and interview, the facility failed to analyze and document infections to establish a baseline on infection incidence in two (2 and 4) out of four patients with infection sampled. Findings included: Review of Patient #2’s medical record shows patient was admitted to the hospital with sepsis (a life threatening complication of an infection, occurs when chemical s released in the blood stream to fight an infection trigger inflammation throughout the body- MAYOCLINIC.COM) and fever on 08/21/2023, on 08/25/2023 patient expired. Review of Patient #4’s medical record shows patient was admitted to the hospital and expired on 01/31/2024 with cause of death severe endocarditis (an infection of the hearts inner lining usually involving the heart valves, it occurs when germs from elsewhere in the body travels through the blood and attach to damaged areas of the heart- MAYOCLINIC.COM). Review of the facility document to report to the CDC’s National Healthcare Safety Network (NHSN)(most widely used healthcare associated infection tracking system) revealed the facility failed to report patients #2 and #4’s infections. No evidence of surveillance for catheter related infections was provided from the facility after numerous requests on 05/28/2024 and on 05/29/2024. During an interview on 05/28/2024 at 12:43 PM with Staff F, Director of Operations, revealed that corporate leadership reports to NHSN for infection and they get the information from the dashboard of each facility that is triggered when an employee puts in the patient medical record that the patient is on antibiotics. Staff F did not respond on to why these patients are not listed. Staff F stated that the facility did not investigate the deaths of patients #2 and #4. An interview was conducted with Staff C, Facility Administrator (FA), On 05/29/2024 at 11:58 AM. Staff C stated that the Equip (facility Electron medical record) did not cross over to the Quality assessment and that is why the mortality and infection is not being tracked and trended with the four patients that have expired. An interview was conducted with staff G, Director of Quality, on 05/29/2024 at 12:29 PM. Staff G stated that major changes had occurred in this facility, and that unfortunately this center has had no manager and no leadership, and things have been missed because of this.”

“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: 20536 Based on staff interview and employee record review, the facility failed to ensure one of three (Staff K) sampled employees reviewed, received training and documented competencies to include tasks to include, but not limited to, skills at testing for chlorine/chloramine levels; operating reuse equipment; identifying and treating intradialytic morbidities, and monitoring patients and equipment alarms during treatment, upon his hire date. Findings included: On 5/29/2024 Staff G, a Regional Director of Operations, provided personnel files with training and education for review. Staff G was not a permanent employee at this facility, but was sent to assist with the survey inspection. Upon review of the employee files the following was revealed: 1. Staff K, who was a Registered Nurse and a permanent employee at the facility, was noted with a hire date of 2/23/2009. Review of the provided “ESRD CORE Survey Facility Worksheet: Personnel File”, revealed “N/A” under Competencies Documented date section. Further interview with Staff G confirmed she could not find any training and documented competencies to include skills at testing for chlorine/chloramine levels; operating reuse equipment; identifying and treating intradialytic morbidities, and monitoring patients and equipment alarms during treatment upon his hire date, nor within the last two years. Staff G revealed she was not a permanent member of this facility but had also communicated with staff development/human resources and they could not find this completed training either. Staff G confirmed there was no evidence to show Staff K was current with this training. On 5/29/2024 at 11:00 a.m. an interview with the interim Facility Administrator (FA), Staff B, revealed she had only been the interim FA for a couple months filling in until a permanent FA could be hired. Staff B also confirmed she could not provide evidence that Staff K had ever received skills at testing for chlorine/chloramine levels; operating reuse equipment; identifying and treating intradialytic morbidities, and monitoring patients and equipment alarms either upon his hire date and within the last two years. On 5/29/2024 at 11:20 a.m. an interview with the incoming FA, Staff C, revealed she has been somewhat working at the facility recently but her original hire date is not until 6/10/2024. She too confirmed she was not able to provide any evidence that Staff K had ever received and completed skills at testing for chlorine/chloramine levels; operating reuse equipment; identifying and treating intradialytic morbidities, and monitoring patients and equipment alarms upon his hire date and within the last two years. Both Staff B and C were not able to provide a policy and procedure related to training requirements for training and competencies for skills at testing for chlorine/chloramine levels; operating reuse equipment; identifying and treating intradialytic morbidities, and monitoring patients and equipment alarms.”