Davita Ocala Regional Kidney Center-East

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 49777 Based on record review and interview, the facility failed to develop amd maintain an emergency preparedness communication plan that included contact information for Federal, State, and Local emergency preparedness staff. Findings include: Record review of Emergency Preparedness Plan did not include names and contact information for Federal, State, and local emergency preparedness staff. During an interview on 3/20/2025 at 11:45 AM, the Administrator confirmed that names and contact information were not included in the facility Emergency Preparedness plan and stated, “ I will revise the plan to include the names and contact information for Federal, State, and local Emergency Preparedness staff. “”

“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: 49777 Based on observation, interview and record review the facility failed to ensure staff followed acceptable infection control standard practices during dialysis treatment care when staff did not perform hand hygiene after doffing gloves and before donning new gloves. Findings include: On 5/15/2023 at 10:08 AM, Staff A, Certified Clinical Hemodialysis Technician, was observed cleaning and disinfecting a dialysis station chair. Staff A doffed gloves and then donned a new pair of gloves after cleaning the dialysis machine and began cleaning the chair. Staff A did not perform hand hygiene before she donned a new pair of gloves. On 5/15/2023 at 10:52 AM, Staff A, Certified Clinical Hemodialysis Technician, was observed during initiation of dialysis through a central venous catheter for Patient #6. Staff A doffed gloves then donned a new pair of gloves, entered data on the computer screen and then connected Patient #6’s catheter lines without performing hand hygiene. On 5/15/2023 beginning at 11:10 AM, Staff B, Patient Care Technician (PCT), was observed during initiation of dialysis through an arterial venous fistula for Patient #1. Staff B doffed gloves and donned a new pair of gloves, retrieved a stethoscope and then assessed Patient #1’s bruit and thrill by directly touching Patient #1. Staff B then retrieved a pad, walked to the sink, applied only water to the pad and wiped Patient #1’s access site with the wet pad. Staff B did not perform hand hygiene before he donned the new pair of gloves. On 5/15/2023 at 11:22 AM, Staff B, PCT left Patient #1’s chair side after touching the computer screen. Staff B then returned to Patient #1’s chair side, attached the dialysis lines to Patient #1’s shirt and taped the dialysis lines to Patient #1 without doffing gloves, performing hand hygiene and donning new gloves. During an interview on 5/16/2023 at 11:32 AM, the Clinical Manager confirmed staff should sanitize their hands after they doff a used pair of gloves and before they don a new pair of gloves during dialysis care. Record review of the policy and procedure titled “Hand Hygiene”, read “The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. All staff, patients, patient care givers, including physician’s and non-physician practitioners, social workers, dieticians and any other indirect patient care staff must follow the same requirements for hand hygiene.Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. Hands should be washed with soap and water or when alcohol-based hand rubs could be used as hands would be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of parental medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands or not visibly soiled, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain, or water lines and after contact with other objects within the patient station or treatment space.””

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 47275 Based on interview and record review, the facility failed to ensure all staff members caring for a Hepatitis B positive patient did not terminate or intiate dialysis treatment for a patient that does not have immunity to Hepatitis B Virus (Patient # 16). Findings include: Record review of Patient #9’s treatment orders dated 3/8/25 reads, “Treatment duration: 3 hours, 30 minutes.” Record review of Patients #9’s treatment detail report dated 3/13/25 showed Staff A, CCHT initiated dialysis treatment for the hepatitis B positive patient at 10:53 AM. Record review of Patient #16 treatment detail report dated 3/13/25 showed staff A, terminated dialysis treatment at 12:11 PM. Record review of Patient #16’s Vaccinations and Surveillance report dated 1/9/25 read, “ HBV Susceptible/ Hepatitus B surface Antibody (HBsAb) Less than 3 (<3). The patient has no current Hepatitis B vaccinations documented.” During an interview on 3/19/25 at 11:38 AM the Facility Administrator stated, “I create the schedule, but I was not here that day, I do not know why the nurse usually assigned to [Patient #9’s Name] was on the floor as a resource nurse, or why she was not assigned to [Patient #9’s Name] We usually will have a dedicated nurse for the entire treatment for [Patient #9’s Name].” During an interview on 3/19/25 at 11:45 AM Staff A CCHT, confirmed the initiation of the dialysis treatment for the hepatitis B positive patient on 3/13/25 at 10:53 AM and confirmed the termination of dialysis treatment on 3/13/25 at 12:11 PM for Patient #16. Review of the policy titled, “Hepatitis B Surveillance, vaccination, infection control measures and isolation guidance” reads, “21. TEAMMATE ASSIGNMENT a. Teammates caring for confirmed or suspect hepatitis B surface antigen positive (HBsAg) positive patient(s) do not care for surface antibody negative (susceptible) patients simultaneously and will only be assigned to care for surface antibody positive (immune) patients.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 49777 Based on observation, interviews and policy/procedure review, the facility failed to ensure that the access sites of 4 patients (Patient #1, #3, #13, and #14) of 15 patients receiving dialysis treatment were consistently visible during dialysis treatments. Findings include: An observation on 3/17/2025 at 10:40 AM, Patient #1 was seated in a treatment chair receiving dialysis treatment through a central venous catheter (CVC). Patient #1’s access site was covered with a blanket and was not visible to staff. Staff were not observed to ask the patient to remove the blanket or educate the patient related to access visibility. An observation on 3/17/2025 at 10:40 AM, Patient #3 was seated in a treatment chair receiving dialysis treatment through an arterial venous fistula (AVF). Patient #3’s access site was covered with a blanket and was not visible to staff. Staff were not observed to ask the patient to remove the blanket or educate the patient related to access visibility. An observation on 3/18/2025 at 9:30 AM, Patient #13 was seated in a treatment chair receiving dialysis treatment through an arterial venous graft (AVG). Patient #13’s access site was covered with a blanket and was not visible to staff. Staff were not observed to ask the patient to remove the blanket or educate the patient related to access visibility. An observation on 3/18/2025 at 9:30 AM, Patient #14 was seated in a treatment chair receiving dialysis treatment through an arterial venous graft (AVG). Patient #14’s access site was covered with a blanket and was not visible to staff. Staff were not observed to ask the patient to remove the blanket or educate the patient related to access visibility. During an interview on 3/17/2025 at 10:45 AM Staff C RN confirmed Patient #1 and Patient #3 had their access sites covered and the patient’s access sites were not visible to staff. During an interview on 3/18/2025 at 10:45 AM Staff B RN confirmed Patient #13 and Patient #14 had their access sites covered and the patient’s access sites were not visible to staff. During an interview on 3/18/2025 at 11:00 AM Facility Administrator stated “Access sites are to be visible to staff at all times and should not be covered.” Record review of the facility policy and procedure “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, with last review date of April 2024, reads “Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. ..2 iv. Verification that the patient access is visible and face is not covered.””

“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: 49777 Based on interview and record review of dialysis treatment flowsheets for 3 patients (Patient #1, #7 and #12) out of 11 patient dialysis treatment flowsheets, the facility failed to ensure monitoring of intradialytic blood pressures, reporting blood pressures outside of acceptable parameters to nursing resulting in a lack of assessment by nursing. Finding include: Record review of Patient #1’s dialysis treatment record dated 2/24/2025, had recorded intradialytic Blood pressure readings of 183/94 at 6:31 AM; 188/97 at 7:02 AM; and 168/100 7:32 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by the Patient Care Technician. Record Review of Patient #1’s dialysis treatment record dated 2/26/2025, had recorded intradialytic Blood pressure readings of 178/123 5:15 AM and 169/109 6:01 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by the Patient Care Technician. Record Review of Patient #1’s dialysis treatment record dated 2/28/2025, had recorded intradialytic Blood pressure reading of 181/105 6:02 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by the Patient Care Technician. Record Review of Patient #1’s dialysis treatment record dated 3/3/2025, had recorded intradialytic Blood pressure reading of 151/115 at 9:06 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by the Patient Care Technician. Record Review of Patient #1’s dialysis treatment record dated 3/7/2025, had recorded intradialytic Blood pressure reading of 158/104 at 8:02 AM ana 173/105 at 9:20 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by the Patient Care Technician. During an interview on 3/18/2025 at 10:30 AM the Administrator, confirmed Resident #1’s Blood Pressures identified during record review were outside of parameters and should have been reported by the Patient Care Technician to the nurse for further assessment. Record Review of Patient #7’s dialysis treatment record dated 3/8/2025, had recorded intradialytic Blood pressure readings of 91/54 at 8:01 AM; 89/45 at 8:31 AM; and 97/53 at 9:09 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by the Patient Care Technician. During an interview on 3/18/2025 at 10:30 AM the Administrator, confirmed Resident #7’s Blood Pressures identified during record review were outside of parameters and should have been reported by the Patient Care Technician to the nurse for further assessment. Record review of Patient #12’s dialysis treatment record dated 3/13/2025, had recorded intradialytic Blood pressure readings of 105/65 at 10:06 AM; 91/58 at 10:31 AM; 87/58 at 11:01 AM; 66/48 at 11:05 AM; 84/52 at 11:07 AM; 85/43 at 11:31 AM; 71/57 at 11:33 AM; 84/51 at 12:01 PM; 78/49 at 12:31 PM; 83/58 at 13:01 (1:01 PM); 80/56 at 13:02 (1:02 PM); 87/42 at 13:31 (1:31 PM); 87/52 at 13:34 (1:34 PM); and 91/55 at 13:36 (1:36 PM) which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by Patient Care Technician. Record review of Patient #12’s dialysis treatment record dated 3/15/2025, had recorded intradialytic Blood pressure reading of 68/52 at 11:32 AM which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by Patient Care Technician. Record review of Patient #12’s dialysis treatment record dated 3/18/2025, had recorded intradialytic Blood pressure reading of 169/147 at 14:01 (2:01 PM); 176/107 at 14:03 (2:03 PM; and 190/105 at 14:25 (2:25 PM) which is outside of the parameters identified by policy and warrants documentation of nurse notification. Nurse notification is not documented by Patient Care Technician. During an interview on 3/18/2025 at 2:50 PM the Administrator, confirmed Resident #12’s Blood Pressures identified during record review were outside of parameters and should have been reported by the Patient Care Technician to the nurse for further assessment. Review of the facility policy and procedure titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, with last review date of April 2024, reads “Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge .... Abnormal Findings: unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the license nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Blood Pressure: Pre-dialysis: Systolic greater than 180 mm (millimeters)/HG (mercury) or less than 90 mm/HG; Diastolic greater than or equal to 100 mm (millimeters)/HG (mercury) or less than 50 mm (millimeters)/HG (mercury); Blood Pressure-Intradialytic: Systolic greater than 180 mm (millimeters)/HG (mercury) or less than 90 mm/HG; Diastolic greater than or equal to 100 mm (millimeters)/HG (mercury) or less than 50 mm (millimeters)/HG (mercury).”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) 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. This Standard is not met as evidenced by: 47275 Based on record review and interview, the facility failed to follow the prescribed blood flow rate (BFR) for 3 patients, Patient #12, #1, #8 , and failed to follow the prescribed dialysate flow rate (DFR) for 3 patients, Patient #1, #4, #11, of 11 in center hemodialysis patients reviewed. Findings Include: 1) Review of Patient #4’s dialysis prescription treatment record, dated 1/28/25, showed Patient #4’s prescribed dialysate flow rate was 800. A review of Patient #4’s dialysis treatment record, dated 3/7/25, revealed the dialysate flow rate was set at 500 during the entire 2 hour and 37 Minute treatment. Review of Patient #4’s dialysis prescription treatment record, dated 1/28/25, showed Patient #4’s prescribed dialysate flow rate was 800. A review of Patientds #4’s dialysis treatment record dated 3/17/25 showed Patient #1’s Dialysate flow rate was set at 500 during the entire 3 hour and 4-minute treatment. Review of Patient #4’s dialysis treatment records failed to reveal documentation that justified or explained why Patient #4’s blood flow rate had deviated from the prescribed blood flow rate. Review of Patient #11’s dialysis prescription treatment record, dated 2/18/25, showed Patient #11’s prescribed Dialysate flow rate was 800. Review of Patient #11’s dialysis treatment record, dated 3/14/25, revealed Patient #11’s Dialysate flow rate was set at 500 during the entire 3 hours and 29 Minute treatment. Review of Patient #11’s dialysis treatment records failed to reveal documentation that was justified or explained why Patient #11’s blood flow rate had deviated from the prescribed blood flow rate. During an interview on 3/19/25 beginning at 11:08 AM, the Facility Administrator confirmed the deviation from Patient #4’s, and Patient #11’s prescribed dialysate flow rate and stated, “There should always be documentation in the clinical record when the BFR/DFR is changed or cannot be reached.” Record review of the facility policy titled “PRE-INTRA-POST TREATMENT COLLECTION, MONITORING, AND NURSING ASSESMENT DATA” Reads, “Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patients dialysis treatment, monitoring during treatment, and for reviewing the patients response to treatment and status prior to discharge. INTRADIALYTIC DATA COLLECTION/ASSESMENT: 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse will be informed.” 49777 2) Review of Patient #1’s dialysis prescription treatment record, dated 3/10/25, showed Patient #1’s prescribed blood flow rate was 350. A review of Patient #1’s dialysis treatment record, dated 3/10/25, revealed the bloood flow rate was set at 400 nine times during dialysis treatment. Review of Patient #1’s dialysis prescription treatment record, dated 3/10/25, showed Patient #1’s prescribed dialysate flow rate was 500. A review of Patient #1’s dialysis treatment record, dated 3/10/25, revealed the dialysate flow rate was set at 800 nine times during dialysis treatment. Review of Patient #1’s dialysis prescription treatment record, dated 3/12/25, showed Patient #1’s prescribed blood flow rate was 350. A review of Patient #1’s dialysis treatment record, dated 3/12/25, revealed the bloood flow rate was set at 345 five times and at 400 three times during dialysis treatment. Review of Patient #1’s dialysis prescription treatment record, dated 3/12/25, showed Patient #1’s prescribed dialysate flow rate was 500. A review of Patient #1’s dialysis treatment record, dated 3/12/25, revealed the dialysate flow rate was set at 800 eight times during dialysis treatment. During an interview on 3/18/2025 at 10:30 AM with the Administrator, confirmed Resident #1’s Blood flow rate and dialysate flow rate were not provided as prescribed and lacked documentation to explain why there was a deviation during treatment. “ Review of Patient #8’s dialysis prescription treatment record, dated 2/14/25, showed Patient #1’s prescribed blood flow rate was 350. A review of Patient #8’s dialysis treatment record, dated 2/14/2025 revealed the blood flow rate was set at 300 one time during dialysis treatment. During an interview on 3/18/2025 at 10:30 AM the Administrator, confirmed Resident #8’s Blood flow rate was not provided as prescribed and lacked documentation to explain why there was a deviation during treatment. “ Review of Patient #12’s dialysis prescription treatment record, dated 3/11/25, showed Patient #12’s prescribed blood flow rate was 300. A review of Patient #12’s dialysis treatment record, dated 3/11/25, revealed the blood flow rate was set at 350 ten times during dialysis treatment. Review of Patient #12’s dialysis prescription treatment record, dated 3/17/25, showed Patient #12’s prescribed blood flow rate was 400. A review of Patient #12’s dialysis treatment record, dated 3/17/25, revealed the blood flow rate was set at 350 six times during dialysis treatment. During an interview on 3/18/2025 at 2:50 PM the Administrator, confirmed Resident #12’s Blood flow rate was not provided as prescribed and lacked documentation to explain why there was a deviation during treatment. “ Review of the policy titled “PRE-INTRA-POST TREATMENT COLLECTION, MONITORING, AND NURSING ASSESMENT DATA” read, “Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patients dialysis treatment, monitoring during treatment, and for reviewing the patients response to treatment and status prior to discharge. INTRADIALYTIC DATA COLLECTION/ASSESMENT: 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse will be informed.””