Davita New Center Dialysis

“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: 38304 Based on observation, interview, and policy review, the facility failed to regularly monitor for a sanitary environment to minimize the transmission of infectious agents and failed to separate dirty/contaminated items from designated “clean areas” used for patient care, potentially effecting all 63 in-center hemodialysis patients currently receiving treatment, resulting in an increased potential for infections. Findings include: On 12/19/23 at 0926 through 0942, it was observed during treatment floor observations, both from below and above, that the overhead lighting directly above patient treatment stations #10 through #13, were contaminated with excessive dust, insect debris, and unknown material(s). In addition, the “CLEAN SINK” area across from station#4 had a red biohazard container stored by the designated clean area. The Facility Administrator (Staff B) acknowledged the findings on 12/19/23 at 1040. When queried when the last time the overhead lights had been cleaned, Staff B was unsure if it had ever been done. Staff B at 1130, submitted a work order to fix non-working lights on the treatment floor. However, no language was found in the work order which addressed the contamination concerns noted above. The facility failed to monitor and adhere to the facility’s policy referenced below. Facility Policy: “Physical Environment”, No. 8-04-01, Revised April 2018 stated, “The dialysis facility will be designed... and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. The dialysis facility will implement and maintain a program to verify all equipment... are maintained and operated in accordance with manufacturer’s recommendations.” 47976 During dialysis floor observation on 12/19/23 at 1000, it was noted the emergency to go box contained the following expired supplies: Approximately 70 Povidone-Iodine Prep pads with the expiration date of 8/2021 1 Bottle of Hand Sanitizer with the expiration date of 4/2022 Findings were reviewed with and acknowledged by the Clinical Manager (Staff Q) at the time of discovery.”

“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: 46476 Based on observation, interview, and record review the facility failed to ensure staff perform hand hygiene between each glove change and failed to ensure staff perform hand hygiene between each patient, resulting in the potential for spread of infectious agents to all 63 incenter patients being served by the facility. Findings include: Facility policy titled “Infection Control for Dialysis Facilities”, Policy: 1-05-01, last revised April 2023 was reviewed on 12/14/23. On page 1 under “Hand Hygiene”, it stated: 1. All teammates... will perform hand hygiene... a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact ... f. between patients even if the contact is casual ... g. before touching clean areas such as supplies ...” On page 2 under “PPE”, it stated: “5. PPE is to be ... Removed prior to leaving the treatment area ... 7 ... iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” On 12/20/23 during incenter hemodialysis treatment floor observation of staff, the following observations were noted: At 0815, Staff K, a Certified Clinical Hemodialysis Technician (CCHT), was observed while performing the procedure of changing a Central Venous Catheter (CVC) dressing and then connecting the CVC to dialysis blood lines to begin dialysis at station #17. During the multi-step procedure, Staff K removed dirty gloves and donned a new pair 6 separate times between tasks without first performing hand hygiene. At 0835, Staff I, a CCHT, was observed while disconnecting a patient’s arteriovenous (AV) fistula from dialysis blood lines at station #4. During the multi-step procedure, Staff I removed dirty gloves and donned a new pair 2 separate times between tasks without first performing hand hygiene. At 0855, Staff I was observed while disconnecting a patient’s AV fistula from dialysis blood lines at station #5. During the multi-step procedure, Staff I was observed removing dirty gloves and donning a new pair of gloves 2 separate times between tasks without first performing hand hygiene. At 0930, Staff K was observed while performing the procedure of changing a CVC dressing and then connecting the CVC to dialysis blood lines to begin dialysis at station #2. During the multi-step procedure, Staff K was observed removing dirty gloves and donning a new pair 4 separate times between tasks without first performing hand hygiene. These findings were reviewed and acknowledged during an interview on 12/21/23 at 1030 with the interim Facility Administrator (Staff P), and the Medical Director (Staff A). Staff A stated that it is expected that all staff will follow the policies and procedures set forth by the facility. 47976 During dialysis floor observation on 12/19/23 and 12/20/23, the following observations were made: On 12/19/23 at 1030, Certified Clinical Hemodialysis Technician (Staff M) was observed disconnecting a patient from dialysis at station #12. During her time at this station, Staff M was observed disconnecting 1 bloodline, removing her gloves and touching the computer keyboard/mouse without performing hand hygiene. She then donned new gloves before continuing the procedure, without performing hand hygiene. She was also observed picking items up off the floor with gloved hands, removing her gloves, and documenting again on the computer without performing hand hygiene. Additionally, Staff M was observed taking items to the Sharps container, removing her gloves, then assisting the patient with her walker without performing hand hygiene first. On 12/19/23 at 1045, Certified Clinical Hemodialysis Technician (Staff I) was observed sitting in a rolling office chair while working with the patient located at station #16. Staff I was then observed rolling 96 feet to the other side of the room with his gloves still on to talk to another staff member and 96 feet back to the nurses station across from station #16 where he removed his gloves and touched the clean desk/computer in that area. He then went into the treatment area at station #17 and donned new gloves without performing hand hygiene first. On 12/19/23 at 1143, Certified Clinical Hemodialysis Technician (Staff I) was observed cleaning station #16. Upon completion of the task, Staff I was observed removing his gloves and donning new gloves to assist the patient at station #17 without performing hand hygiene first. On 12/19/23 at 1350, Certified Clinical Hemodialysis Technician (Staff M) was observed working with the patient at station #17. During her time at this station, Staff M was observed grabbing the trash can with her gloved hands, removing her gloves, then going to get clean supplies from the cart without performing hand hygiene first. She then returned to station #17 and donned new gloves without performing hand hygiene. Findings were reviewed with and acknowledged by the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 1215.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 47976 Based on observation and record review, the facility failed to ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient, resulting in the potential to spread infectious diseases to all 63 patients receiving in-center dialysis at this facility. Findings include: **Policy 1-05-01 titled “Infection Control for Dialysis Facilities” (revised April 2023) stated, “14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses.” During dialysis floor observation on 12/19/23 at 1045, Certified Clinical Hemodialysis Technician (Staff I) was observed sitting in a rolling office chair while working with the patient located at station #16. Staff I was then observed rolling 96 feet to the other side of the room to talk to another staff member, 96 feet back to the nurses station across from station #16, and then into the treatment area at station #17 to work with another patient without disinfecting the chair in between. Findings were reviewed with and acknowledged by the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 1215. 46476 On 12/19/23 during incenter hemodialysis treatment floor observation of staff, the following observation was noted: At 1135, Staff I, a Certified Clinical Hemodialysis Technician (CCHT), was observed retrieving a thermometer from the computer between stations #16 and #17 and going into station #16 to take the patient’s temperature. Staff I then returned the thermometer to the computer between stations #16 and 17 (clean area between 2 stations) without first disinfecting it. On 12/20/23 during incenter hemodialysis treatment floor observation of staff, the following observation was noted: At 0835, Staff I, a CCHT, was observed while disconnecting a patient’s arteriovenous (AV) fistula from dialysis blood lines at station #4. During the procedure, Staff I was observed leaving station #4 treatment area, collecting a blood pressure cuff from station #6 (another patient was at station #6), and bringing it back to station # 4 to use on the patient at station #4 without first disinfecting it. These findings were reviewed and acknowledged during an interview on 12/21/23 at 1030 with the interim Facility Administrator (Staff P), and the Medical Director (Staff A). Staff A stated that it is expected that all staff will follow the policies and procedures set forth by the facility.”

“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: 46476 Based on observation and interview, the facility failed to ensure staff disposed of infectious waste in a safe manner resulting in the potential for the spread of infectious agents to the 14 patients being served by the facility at the time of observation. Findings include: On 12/19/23 during incenter hemodialysis treatment floor observation of staff, the following were noted: At 1135, Staff I, a Certified Clinical Hemodialysis Technician (CCHT), was observed while removing blood lines and discontinuing dialysis for the patient at station #16. During the procedure, Staff I took sharps containing blood from the patient at station #16 to dispose of them in a sharps container which was in station #17 (where another patient was being treated at the time). At 1150, Staff K, a CCHT, was observed while removing blood lines and discontinuing dialysis for a patient at station #14. During the procedure, Staff K took sharps containing blood from the patient at station #14 to dispose of them in a sharps container which was in station #15 (where another patient was being treated at the time). An interview was conducted with the Clinical Manager (Staff Q) on 12/19/23 at 2pm and Staff Q was queried to why staff would need to take used sharps from one station to an adjacent station to dispose of where another patient was receiving treatment. Staff Q stated that the facility has plenty of sharps containers and was unsure of why staff would take used sharps to adjacent stations. Staff Q agreed that used sharps should not enter another treatment station. These findings were reviewed and acknowledged during an interview on 12/21/23 at 1030 with the interim Facility Administrator (Staff P), and the Medical Director (Staff A).”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 46476 Based on observation, interview, and record review, the facility failed to ensure staff maintained aseptic technique when providing care to patients with intravascular catheters during 2 of 4 observations (Station #16 and 17) resulting in an increased risk for infection and potential for poor patient outcomes. Findings include: Facility policy titled, “Central Venous Catheter (CVC) with TEGO Connectors or CVC End Caps Procedure”; Procedure: 1-04-02A; Last revised: October 2023, was reviewed on 12/21/23. On page 2., under “Additional Notes”, it stated: “ ... If using a CVC end cap, perform a 15 second hub scrub every time the CVC is connected or disconnected from the blood lines ...”. 47976 During dialysis floor observation on 12/19/23 at 1130, Certified Clinical Hemodialysis Technician was (Staff I) was observed disconnecting a patient with a central venous catheter (CVC) from dialysis at station #16. Upon disconnecting the hubs from the bloodlines, it was noted Staff I scrubbed one for 6 seconds and the other for 8 seconds before connecting the syringe of saline. During dialysis floor observation on 12/20/23 at 1350, Certified Clinical Hemodialysis Technician (Staff M) was observed disconnecting dialysis from a central venous catheter (CVC) on the patient at station #17. Upon disconnecting the hubs from the bloodlines, it was noted Staff M scrubbed one side for 6 seconds and the other for 5 seconds before connecting the syringe of saline. After removing the syringe of saline, Staff M scrubbed the hubs again for 5 seconds and 6 seconds, respectively. Findings were reviewed with and acknowledged with the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 1215.”

“BACT CONTROL-SUPPLY LINE DISINFECTED CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: machine supply line disinfected Users should establish a procedure for regular disinfection of [the line between the outlet from the water distribution system and the back of the dialysis machine]. This Standard is not met as evidenced by: 47976 Based on observation and interview, the facility failed to ensure staff used unexpired test strips for testing residual chlorine levels in all 17 hemodialysis machines after the disinfection process of the machine water lines. This practice has the potential to result in undetected levels of a harmful disinfectant being distributed to all 63 patients receiving hemodialysis at this facility. Findings include: During a flash tour of the hemodialysis treatment floor on 12/19/23, a bottle of Residual Chlorine test strips was found in the 2nd drawer of the clean supply cart located near pod #2. It was discovered the bottle had previously been opened and the expiration date was 1/31/23. Findings were reviewed with and acknowledged by the Clinical Manager (Staff Q) at time of discovery.”

“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: 39083 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment and properly secure a compressed air canister, resulting in the potential for uncleanable surfaces and a hazard to health and safety, affecting all patients and staff in the facility. Findings include: On 12/19/23 at 11:12 AM, dust and mineral deposits were observed accumulating at the wall/floor juncture underneath the chase system at station 6. At the time of observation, Biomed “G” stated that the cleaning services are contracted. On 12/19/23 at 11:15 AM, a compressed Oxygen canister was observed to be stored unsecured on the treatment floor near the clean sink across from station 5. At this time, Biomed “G” removed the Oxygen tank canister and properly secured it. On 12/29/23 at 11:16 AM, stations 1, 14, 13, and 18 were observed to have excessive bicarb mineral build up accumulating at the wall/floor juncture under the chase systems. The mineral accumulation in these areas were approximately 1/8 to 1/4 inch thick. According to the facility’s policy, “PHYSICAL ENVIRONMENT,” revised April 2018, it notes, “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. 2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public... 10. The dialysis facility will store supplies in a manner that is consistent with fire safety and other appropriate regulations. Supplies will not obstruct any fire exits or hallways. Refer to: Monthly OSHA and Safety Checklist for further guidance or as required by local jurisdiction requirements. Supplies are stored as to minimize deterioration, contamination or breakage. Supplies will not be stored directly on the floor but stored on shelves or pallets if allowable per specific state or local codes.””

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to have Against Medical Advice documentation concerning early termination of dialysis treatment by the patient for 2 (Patients #4, 5) of 7 total sample patients per their policy, resulting in the potential for the patient to not understand their right to refuse or the possible consequences of early termination. Findings include: **Policy 1-01-09 titled “Prescribed Treatment Time Not Met” (revised October 2023) stated, “A copy of the Early Termination of Treatment Against Medical Advice form signed by the patient, if shortened voluntarily by the patient, will be kept in the patient’s health record.” It also stated, “If a patient refuses to sign the Early Termination of Treatment Against Medical Advice form, the RN (registered nurse) will document the patient’s refusal with the words ‘patient refused’ in the patient signature box along with the date. Under such circumstances, the RN will sign the form and will also obtain a witness’ signature on the form.” P-4: This 71-year-old patient was admitted to this dialysis facility on 1/4/12 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week for an ordered duration of 180 minutes. During record review on 12/20/23, it was determined 8 of the last 10 AMA forms for shortened treatments (dated between 12/4/21 and 9/21/23) were not signed by the patient and it was not noted the patient refused. P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week for an ordered duration of 195 minutes. During record review on 12/20/23, it was determined 15 of the last 20 AMA forms for shortened treatments (dated between 8/19/23 and 12/19/23) were not signed by the patient and it was not noted the patient refused. The interim Facility Administrator (Staff P) was queried during an interview on 12/21/23 regarding the expectation for patient signatures on the forms. Staff P stated it is expected the patient signs each form as well as a reason given for the shortened treatment time. If the patient refuses to sign, Staff P stated that should be documented as well. She acknowledged the findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to ensure the appropriateness of the dialysis prescription was met in 2 (P-3, P-5) of 7 in-center patients, out of a total sample of 7 records, resulting in the potential for less-than-optimal patient outcomes for all 63 in-center patients currently receiving services. Findings include: P-3: This patient was admitted to the facility on 12/22/2009, with diagnoses which included end-stage renal failure, hypertension, and anemia. On 12/20/2023, review of P-3’s active orders (effective 10/4/2023), noted the “Max UF” (upper limit of ultra filtration) was 13 mL/kg/hr. Further review of recent UF rates delivered during the last 13 treatments (11/21/23 through 12/19/23) revealed 5 of 13 treatments exceeded the maximum prescribed UF. They are as follow: On 11/21/23-14.3 mL/kg/hr.; 11/25/23-17.3 mL/kg/hr.; 11/30/23-27.3 mL/kg/hr.; 12/5/23-14.0 mL/kg/hr.; and 12/14/23-14.0 mL/kg/hr. This adversely effects the patient as research (referenced below) has recently shown the “median survival rate was significantly longer for patients in the bottom quartile (UF less than 13 mL/kg/hr.) than top quartile (UF greater than 13 mL/kg/hr.): 8.8 vs. 5.6 years.” No documentation was found in the medical record which alerted a registered nurse or physician for potential safety interventions. The above findings were reviewed and acknowledged by the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 0940 and was noted this failed to comply to the facility’s policy referenced below. Facility Policy: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” No. 1-03-08 stated, “The prescription components are confirmed by a licensed nurse within (1) hour of treatment initiation... Prescription components include but are not necessarily limited to: UFR and Max UFR... UF Profiling. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... The licensed nurse notifies the physician as needed of changes in patient status.” Research Article: Navarrete JE, Rajabalan A, Cobb J, Lea JP. Proportion of hemodialysis treatments with high ultrafiltration rate and the association with mortality. Kidney360. Published online May 5, 2022. 47976 P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/20/23, it was noted the “Max UF” (upper limit of ultrafiltration) was 13 milliliters per kilogram per hour (mL/kg/hr) according to the most recent treatment orders dated 12/9/23. Upon review of the 4 treatments done on/after 12/9/23, the UF was recorded as follows: 13.9 mL/kg/hr on 12/9/23 24.6 mL/kg/hr on 12/12/23 18.6 mL/kg/hr on 12/16/23 16.1 mL/kg/hr on 12/19/23 During an interview on 12/21/23 at 1030, the Medical Director (Staff A) was queried regarding when values higher than 13 mL/kg/hr should be reported to the physician and addressed. Staff A reported any treatment with a UF higher than 13 mL/kg/hr is a significant finding that should be addressed. During an interview on 12/21/23 at 1215, the interim Facility Administrator (Staff P) was queried whether there was documentation stating the physician had been notified or the interdisciplinary team had discussed these values. Staff P was unable to provide evidence that the interdisciplinary team was aware and addressing the issue. She acknowledged the findings.”

“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: 47976 Based on record review and interview, the facility failed to ensure that each patient new to dialysis had a comprehensive assessment completed within 30 days or 13 treatments of admission in 1 (Patient #5) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 and was receiving dialysis treatment 3 times per week. During record review on 12/20/23, it was determined the 30 day comprehensive assessment was never completed. According to the record, the only comprehensive assessment that was completed was the 90 day comprehensive assessment that was done on 3/22/23. The 30 day comprehensive assessment was due by 1/12/23. The interim Facility Administrator (Staff P) was interviewed on 12/21/23 at 1215 regarding any documentation of the 30 day assessment being completed. Staff P was unable to provide any evidence the assessment occurred or any documentation regarding a reason for it not being completed. Staff P acknowledged the findings.”

“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: 38304 Based on record review and interview, the facility failed to ensure staff notified the registered nurse (RN) of elevated BP readings per facility policy in 2 (Patient # 2, and 3) of 7 records reviewed, out of sample of 7 records reviewed, and failed to report a change in target weight per facility policy in 1 (Patient # 6) of 7 records reviewed resulting in a reporting practice with the potential for unrecognized changes in volume status and poor patient outcomes for all 63 in-center hemodialysis patients currently receiving treatment. Findings include: P-2: This patient was admitted to the facility on 9/8/2023 with diagnoses which included end-stage renal disease, hypertension, diabetes-type 2, and anemia. P-2 was receiving treatments 3 times per week (Mon-Wed-Fri) for an ordered duration of 225 minutes each treatment. On 12/20/23, record review of P-2’s six most recent dialysis treatment sheets found that on 12/6/23, a run of 8 consecutive elevated BP readings failed to document RN notification with readings greater than 180 mm/Hg. (systolic) and/or BP greater than 100 mm/Hg. (diastolic) per facility expectations and policy noted below. The 8 recordings on 12/6/23 are as follow: At 0804 (Pre-treatment), BP was 193/97 At 0816, BP was 189/95 At 0831, BP was 195/98 At 0901, BP was 205/104 At 0912, BP was 213/102 At 0915, BP was 203/100 At 0931, BP was 209/97 At 0932, BP was 204/100 No RN notification regarding P-2’s elevated BP readings were found in 8 of 8 opportunities. P-3: This patient was admitted to the facility on 12/22/2009, with diagnoses which included end-stage renal failure, hypertension, and anemia. P-3 was receiving treatments 3 times per week (Tues-Thu-Sat) for an ordered duration of 180 minutes each treatment. On 12/20/23, record review of P-3’s six most recent dialysis treatment sheets found that on 12/2/23, a run of 10 consecutive elevated BP readings failed to document RN notification with readings greater than 180 mm/Hg. (systolic) and/or BP greater than 100 mm/Hg. (diastolic) per facility expectations and policy noted below. The 10 recordings on 12/2/23 are as follow: At 0508, BP was 191/80 At 0509, BP was 188/96 At 0530, BP was 198/88 At 0600, BP was 189/73 At 0630, BP was 209/83 At 0700, BP was 197/71 At 0730, BP was 187/96 At 0800, BP was 196/69 At 0809, BP was 186/72 (treatment terminated) At 0813, BP was 217/106 (post-treatment, standing) P-3 was then sent home with no RN notification, no re-check of the 217/106 post-treatment BP, no potential interventions such as BP medication(s), and no physician notification was evidenced in the medical record. The above findings were reviewed and acknowledged by the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 0945 and noted this failed to adhere to the facility’s expectations and policy referenced below. Facility Policy: “Pre-Intra-Post Treatment Data collection, Monitoring and Nursing Assessment” No. 1-03-08 (Revised October 2023) stated, “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. Blood Pressure-Pre-dialysis (Also applies to intradialytic per Staff P) Systolic greater than 180 mm Hg... Diastolic greater than or equal to 100 mm Hg. Blood Pressure-Post Treatment: Standing systolic BP greater than 140 mm Hg.” 46476 Facility policy titled: “Pre-Intra-Post Treatment Data collection, Monitoring and Nursing Assessment”; Policy: 1-03-08; Last revised October 2023 was reviewed on 12/21/23. On page 5., it stated, “ ... the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record ...Post-treatment: If patient is above or below 1 kg from the target weight”. P-6: This 58-year-old was admitted to facility on 9/28/21 with end stage kidney disease and high blood pressure. The medical record was reviewed on 12/20/23 and included 6 treatment sheets between the dates of 12/7/23 and 12/19/23. The active physician order for the period of review included a target weight of 80.5 kilograms (kg), or 177.1 pounds. During review, it was noted on the treatment sheet dated 12/16/23 that P-6 had a pre-weight (prior to dialysis) of 85.6 kg, or 188.7 pounds, and a post-weight (after dialysis) of 65.4, or 144.2 pounds. This is a weight loss of 15.1 kg, or 33.3 pounds. There was no documentation that the nurse was aware of the change between the pre-dialysis and post-dialysis weights. These findings were reviewed and acknowledged during an interview on 12/21/23 at 1030 with the interim Facility Administrator (Staff P), and the Medical Director (Staff A). Staff P stated that it was most likely an error in entered weight however, no documentation could be found to support whether the weight difference was in error, investigated, or reported to either a nurse or physician.”

“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: 46476 Based on record review and interview, the facility failed to ensure the delivery of the dialysis prescription as ordered in 5 (Patient # 1, 2, 4, 5, and 6 ) of 7 sample records reviewed potentially resulting in less than optimal adequacy, and failed to investigate root cause for routinely shortened or missed dialysis treatments in 2 (Patient # 5 and 7) out of 7 sample records reviewed resulting in reduction in adequacy below the goal in the patient plan of care and the potential for poor outcomes. P-6: This 58-year-old was admitted to facility on 9/28/21 with end stage kidney disease and high blood pressure. The medical record was reviewed on 12/20/23 and included 6 treatment sheets between the dates of 12/7/23 and 12/19/23. The active physician orders for the period reviewed included dialysis to be run with a dialysate flow rate (DFR) of 800 milliliters/minute (mL/min). During review of treatment sheets, the following was noted: On the treatment sheet dated 12/9/23, the DFR was ran at 500 mL/min (300 mL/min less than prescribed) for the entire treatment duration (183 minutes). On the treatment sheet dated 12/16/23, the DFR was ran at 500 mL/min (300 m/L min less than prescribed) for the entire treatment duration (183 minutes). There was no documentation on either of the above dated treatment sheets for why the dialysis treatment was not delivered as prescribed. These findings were reviewed and acknowledged during an interview on 12/21/23 at 1030 with the interim Facility Administrator (Staff P), and the Medical Director (Staff A). Staff A stated that it is expected that all staff will follow the policies and procedures set forth by the facility. Facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”; Policy: 1-14-01; Last revised: July 2023, was reviewed on 12/21/23. On page 2., it stated: “6. The adequacy of the patient’s dialysis prescription will be assessed on an ongoing basis ... For hemodialysis patients, at least monthly ...”. On page 4., it stated: “ ... if the expected outcome is not achieved, the interdisciplinary team ... will adjust the patient’s plan of care to achieve the specified goal. When a patient is unable to achieve the desired outcomes, the team will: Adjust the plan of care to reflect the patient’s current condition; Document in the patient’s medical record the reasons why the patient was unable to achieve the goals; Implement plan of care changes to address the issues identified.”. P-7: This 74-year-old was admitted to facility on 12/18/20 with end stage kidney disease; type 2 Diabetes; and high blood pressure. The medical record was reviewed on 12/20/23 and included 6 treatment sheets between the dates of 12/1/23 and 12/13/23. Active physician orders for the period reviewed included hemodialysis to be done incenter three times per week for a duration of 210 minutes per treatment. During review, it was noted that treatment had been shortened on 5 of the 6 treatments reviewed and was noted as follows: On 12/1/23, the treatment was shortened by 89 minutes. On 12/4/23, the treatment was shortened by 90 minutes. On 12/6/23, the treatment was shortened by 86 minutes. On 12/11/23, the treatment was shortened by 79 minutes. On 12/13/23, the treatment was shortened by 83 minutes. Upon further record review, it was noted that the lab which measures adequacy (measured in Kt/V: clearance of toxins in the patient’s blood multiplied by time of dialysis divided by volume of blood) of the dialysis prescription was found to be lower than the goal in the plan of care (POC) of 1.2 milliliters per minute (mL/min) for the last 3 months as was set forth in the stable POC dated 4/24/23, as follows: On 10/11/23, adequacy was measured as 0.9 mL/min (0.3 mL/min less than goal). On 11/15/23, adequacy was measured as 0.9 mL/min (0.3 mL/min less than goal). On 12/11/23, adequacy was measured as 1.0 mL/min (0.2 mL/min less than goal). It was also noted on the above dated POC that the Registered Dietician (Staff F) stated that the patient was shortening treatments by 70 minutes on average and that staff would reinforce importance of treatment time. On the 5 treatments dated 12/1/23 through 12/13/23 (the dates that treatments were shortened), there was an Against Medical Advice (AMA) form which gave information on consequences of leaving treatment early found in the medical record that was signed by only staff and indicated that the patient refused to sign (no education documented). During interview on 12/21/23 at 1120 with the Interim Facility Administrator (Staff P) these findings were reviewed, and Staff P was queried to whether there was documentation that could show that staff had investigated the root cause to why P-7 had been shortening treatment times for the period reviewed. Staff P was not able to provide documentation that gave evidence that staff had investigated why P-7 was shortening treatments. There was no documented evidence that P-7 was aware of consequences of early termination of treatment. There was no evidence that staff had adjusted the POC so P-7 would achieve adequacy goals. 47976 tP-4: This 71-year-old patient was admitted to this dialysis facility on 1/4/12 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/20/23, it was determined the BFR was ordered at 500 milliliters per minute (mL/min) and the DFR was ordered at 500 mL/min. Upon review of the last 6 treatment sheets, it was noted the BFR and DFR were run incorrectly as follows: On 12/5/23, the DFR was run at 800 mL/min for the entire duration of the treatment (187 minutes) On 12/7/23, the BFR was run at 400 mL/min for the entire duration of the treatment (181 minutes) There was no documentation on the treatment sheets for the reason the BFR and DFR were not met or of the licensed nurse being notified. P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 and was receiving dialysis treatment 3 times per week. During record review on 12/20/23, it was determined the BFR was ordered at 450 milliliters per minute (mL/min) and the DFR was ordered at 800 mL/min. Upon review of the last 6 treatment sheets, it was noted the BFR and DFR were run incorrectly as follows: On 12/2/23, the BFR was recorded at 215 mL/min at 0544, 270 mL/min at 0601, 0631 and 0701, 300 mL/min at 0731, 0801 and 0822 (total of 158 minutes) On 12/5/23, the DFR was run at 500 mL/min for the entire treatment (128 minutes) On 12/9/23, the DFR was run at 500 mL/min for the entire treatment (164 minutes) On 12/12/23, the BFR was recorded at 200 mL/min at 0600, 350 mL/moin at 0631 and 0701, 0 mL/min at 0732, 235 mL/min at 0801 and 175 mL/min at 0831 (total of 151 minutes); the DFR was run at 500 mL/min for the entire duration of the treatment (151 minute) On 12/16/23, the BFR was recorded at 200 mL /min at 0620, 325 mL/min at 0631, 0 mL/min at 0701, 300 mL/min at 0731 and 0801, 0 mL/min at 0831 and 300 mL/min at 0901 and 0938 (total of 198 minutes) On 12/19/23, the DFR was run at 500 mL/min for the entire treatment (149 minutes) There was no documentation of the reason the BFR and DFR were not met or of the licensed nurse being notified. During an interview on 12/21/23 at 1215, the interim Facility Administrator (Staff P) was queried whether there was documentation of the reason the BFR and DFR were not met during these treatments or if there were any special orders to change the rates on those days. Staff P was unable to provide documentation showing this, however she acknowledged there should be evidence in the record anytime the rates are not run as prescribed. ___ P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 and was receiving dialysis treatment 3 times per week. During record review on 12/20/23, the plan of care dated 3/21/23 was reviewed. The plan of care identified the patient was not meeting several goals, including fluid management and adequacy. Upon further review of this plan of care, it was noted the registered dietician (Staff F) documented, “Pt continues to not be at treatment. Made 6/12 treatments the last month. Will educate when pt shows for tx,” and “Pt misses half of tx and leaves 67% of tx over TW (target weight). RD (registered dietician) will follow up with pt when he shows.” During an interview on 12/21/23 at 1215, the interim Facility Administrator (Staff P) was queried regarding documentation of education provided to this patient about missed visits and its effect on treatment effectiveness. Staff P was unable to provide documentation this patient had received education from Staff F to address the above concerns at any time. Upon review of the patient’s most recent data, this continues to be an ongoing problem with this patient with no steps documented to help correct. Staff P acknowledged the findings. 38304 P-1: This patient was admitted to the facility on 11/24/2023 with diagnoses which included end-stage renal disease, hypertension, diabetes-type 2, and anemia. During record review on 12/20/23, it was determined the treatment order for P-1 (effective 11/24/23) was written for a blood flow rate (BFR) of 400 milliliters per minute (mL/min). During review of the last 6 treatment sheets, it was noted the BFR was run at 275 mL/min for the entire treatment on 12/11/23. In 10 of 10 opportunities from 0920 through 1222, no documentation was evidenced in the medical record which explained why the BFR was delivered at a significantly lower rate than what was prescribed. The overseeing RN (Staff D) signed off on 12/11/23 at 0948 “that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” In addition, the patient care technicians (Staff I, J, and O) failed to notify/document to an RN the BFR was 275 mL/min. in 10 of 10 opportunities. The above findings were reviewed and acknowledged by the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 0915 and noted this failed to adhere to the facility’s policy referenced below. P-2: This patient was admitted to the facility on 9/8/2023 with diagnoses which included end-stage renal disease, hypertension, diabetes-type 2, and anemia. During record review on 12/20/23, it was determined the treatment order for P-2 (effective 11/29/23) was written for a dialysis flow rate (DFR) of 600 mL/min. During review of the last 6 treatment sheets, it was noted on 12/11/23, the DFR was changed from 600 mL/min. to 800 mL/min. for the last four entries (1031 through 1201) prior to treatment completion. No rationale was found in the medical record why the DFR was changed. In addition, review of the treatment sheet dated 12/15/23, found entire treatment had the DFR being delivered at 500 mL/min. in 10 of 10 opportunities (0817 through 1202). No documentation was found which explained why the DFR was delivered at a significantly lower rate than what was prescribed. The overseeing RN (Staff D) signed off on 12/15/23 at 1009 “that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” In addition, the patient care technician (Staff I) failed to notify/document to an RN the DFR was 500 mL/min. in 10 of 10 opportunities. The above findings were reviewed and acknowledged by the interim Facility Administrator (Staff P) during an interview on 12/21/23 at 0925 and noted this failed to adhere to the facility’s policy referenced below. Facility Policy: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” No. 1-03-08 stated, “Intradialytic Data Collection/Assessment: 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 informed.””

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 38304 Based record review and interview, the facility’s Quality Assessment Performance Improvement (QAPI) program failed to assess, analyze, and incorporate measures to improve aggregate data concerning the facility’s patient transplant waitlist for the last two years, resulting in the potential to negatively impact all 63 patients currently receiving services at this facility. Findings include: On 12/20/23 at 1350, the facility’s QAPI program was reviewed with the Facility Administrator (Staff B) and Clinical Manager (Staff Q). Review was completed of multiple facility concerns, including but not limited to hospitalizations, infections, water and dialysate quality, complaints and grievances, dialysis treatment adherence to facility policy and procedures, as well as discussion of performance improvement projects (PIP’s). During QAPI review, the facility’s PIP concerning patient transplant waitlist was chosen due to a 78% lower than expected value vs. national averages identified during pre-survey. The most 6 recent months revealed a failure by the facility to document overall rationale which would explain the significantly lower expected value surrounding patient transplant waitlist data. Subsequently, request was made to review the transplant waitlist monthly data reports going back to January 2022. Additional review of any documentation (Governing Body meeting minutes, Master of Social Work notes, and FHR (facility health reports) was also performed. Each of the months (Dec. 2022 through Nov. 2023 or 12 of 12 opportunities) documented the following word for word each month, with no further information provided by the facility at the time of exit. Issue Statement: “Not meeting (Corporate) goals. Facility not meeting CMS goal of > (greater) than 20.1% of patients on active transplant list.” Process Improvement Goals(s): “To increase active transplant population as permitted.” Process Deep Dive: “Non-viable candidates, root causes: 1. Lack of family support system 2. Multiple medical comorbidities 3. lack of follow up with transplant referral workup evaluations 4. Not interested 5. Expired 6. Harper transplant clinic closing.” Action(s) and interventions: “Continue to follow up with the patients who are in the workup stage and encourage their follow up and completion of testing. Continue to educate patients quarterly on transplantation as a treatment option.” IP Evaluation Plan: “We will continue to evaluate on a monthly basis for appropriate candidates and discuss monthly with MD at FHM.” Request was then made to Staff B and Q to submit any documentation which would support efforts made to improve the transplant data using the interventions identified above. No evidence was submitted at the time of exit on 12/21/23 at 1345. In addition, further review revealed only 3 of 23 months (March, April, and May of 2023) had only 1 patient (2.7% vs. goal of 20.1%) on the transplant waitlist. The remaining 20 months had 0% which documented, “There are no patients active on the transplant list.” The facility failed to show any efforts within its QAPI program for the last two years to significantly improve and achieve the CMS national expectation of 20.1% of patients on the active transplant list. The above findings were reviewed and acknowledged by Staff B and Staff Q during an interview on 12/20/23 at 1545 and noted this failed to meet facility expectations and facility policy referenced below. Facility Policy: “Continuous Quality Improvement Program” No. 1-14-06 (Revised April 2021) stated, “The facility will measure, analyze, and track quality indicators or other aspects of performance. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure the Initial Nursing Assessment was performed by a registered nurse prior to initiation of treatment in 1 (Patient #5) of 7 records reviewed; and failed to ensure the physician was notified of visits that were shortened greater than 30 minutes per facility policy in 3 (Patient # 5, 6 and 7) of 7 records reviewed, resulting in the potential for poor patient outcomes. Finding included: **Policy 1-03-07 titled “CWOW-Initial Patient Nursing Assessment for New Patients” (revised October 2021) stated, “A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility.” P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 and was receiving dialysis treatment 3 times per week. During record review on 12/20/23, it was noted the Initial Nursing Assessment did not have a time it was completed documented, therefore, it can not be determined whether the assessment was completed before the first treatment. During an interview on 12/21/23 at 1215, the interim Facility Administrator (Staff P) was queried regarding when the Initial Nursing Assessment should be completed. Staff P stated it should be completed prior to the first dialysis treatment. She acknowledged this cannot be determined if time is not written on the form. __ **Policy 1-01-09 titled, “Prescribed Treatment Time Not Met” (revised October 2023) stated, “If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs.” P-5: This 39-year-old patient was admitted to this dialysis facility on 11/29/22 and was receiving dialysis treatment 3 times per week for a duration of 195 minutes. During record review on 12/20/23, it was determined that since 9/1/23, the following visits were shortened by greater than 30 minutes: 9/21/23 = 45 minutes 9/26/23 = 60 minutes 10/7/23 = 75 minutes 10/24/23 = 75 minutes 10/28/23 = 51 minutes 10/31/23 = 35 minutes 11/4/23 = 30 minutes 11/11/23 = 45 minutes 11/14/23 = 45 minutes 11/18/23 = 45 minutes 12/2/23 = 45 minutes 12/5/23 = 75 minutes 12/9/23 = 45 minutes 12/12/23 = 75 minutes 12/19/23 = 55 minutes There was no evidence that noted the physican was contacted per facility policy. During an interview on 12/21/23 at 1215, interim Facility Administrator (Staff P) was queried regarding documentation that would show the physician was contacted about these visits. Staff P stated there was no evidence of this in the record. She acknowledged the findings. The Medical Director (Staff A) was interviewed on 12/21/23 at 1030. During the interview, Staff A stated it is expected that all staff will follow the policies and procedures set forth by the facility. 46476 P-6: This 58-year-old was admitted to facility on 9/28/21 with end stage kidney disease and high blood pressure. The medical record was reviewed on 12/20/23 and included 6 treatment sheets between the dates of 12/7/23 and 12/19/23. During review it was noted: On 12/7/23, the treatment was shortened by 32 minutes. On 12/14/23, the treatment was shortened by 56 minutes. There was no documented evidence in the medical record indicating the physician was aware of the above shortened treatment times. P-7: This 74-year-old was admitted to facility on 12/18/20 with end stage kidney disease; type 2 Diabetes; and high blood pressure. The medical record was reviewed on 12/20/23 and included 6 treatment sheets between the dates of 12/1/23 and 12/13/23. During review it was noted: On 12/1/23, the treatment was shortened by 89 minutes. On 12/4/23, the treatment was shortened by 90 minutes. On 12/6/23, the treatment was shortened by 86 minutes. On 12/11/23, the treatment was shortened by 79 minutes. On 12/13/23, the treatment was shortened by 83 minutes. There was no documented evidence in the medical record indicating the physician was aware of the dates above with shortened treatment times. These findings were reviewed and acknowledged during an interview on 12/21/23 at 1030 with the interim Facility Administrator (Staff P), and the Medical Director (Staff A). Staff A stated that it is expected that all staff will follow the policies and procedures set forth by the facility.”