Davita Rainbow City 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: 39098 Based on observations, facility policy, and interviews with staff, it was determined the facility failed to ensure treatment chairs were maintained and free of tears in the vinyl. This had the potential to affect all patients dialyzing at this facility. Findings include: Facility Policy: Infection Control for Dialysis Facilities Policy Number 1-05-01 Date Revised: April 2023 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...Disinfection 13. At the end of treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include... all surfaces in contact with the patient... (dialysis chair...) Observations of care were conducted on the treatment floor on 1/9/24 at 10:00 AM. Two chairs on the treatment floor were observed to have cracks in the vinyl in the seat of the chair. One had an approximate five inch long crack with multiple small cracks running perpendicular to the long crack. Another chair had a single, approximate five inch long crack in the center of the seat. A tour of the peritoneal dialysis home training room was conducted on 1/9/24 at 3:00 PM with Employee Identifier (EI) # 6, Registered Nurse, Peritoneal Dialysis Training Nurse. The patient chair was observed to have cracks in the vinyl in the seat of the chair, Approximately 2 inches each. An interview was conducted on 1/11/24 at 10:11 AM with EI # 1, Facility Administrator, who confirmed the cracks in the chairs.”

“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: 47295 Based on observations, facility policies, and interviews, it was determined the facility failed to ensure staff followed the facility policy for hand hygiene. This affected one of two observations of Cleaning and Disinfection of the Dialysis Station, one of two observations of AV (Arteriovenous) Fistula or Graft Access, and including PI # 11, one of two Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft, including PI # 7, and had the potential to affect all 47 In-Center Hemodialysis (ICHD) patients that dialyze at this facility. Findings include: Facility Policy: Infection Control for Dialysis Facilities Policy number: 1-05-01 Revision Date: April 2023 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Hand Hygiene: All teammates, physicians, and non-physicians will perform hand hygiene (HH): ...b. prior to gloving and immediately after removal of gloves... ...d. after patient and dialysis delivery system contact... ...g. before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse... ...3. Use of an alcohol-based hand rub may be substituted for handwashing... PPE: ...7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station... ...a. Gloves should be changed when: ...ii. When going from a “dirty” area or task to a “clean” area or task... Facility Policy: AV Fistula or Graft Cannulation... Procedure Number: 1-04-01E Date Revised: October 2022 ...Materials required: ...70 % alcohol preps ...Skin antiseptic ...Notes ...Use Isopropyl Alcohol 70 % as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics. Skin Antiseptic: Isopropyl Alcohol 70 % Effective Volume: At least 4 prep pads per site Effective Contact Time: 60 seconds Air Drying Time: 15 seconds Procedure: ...2. Perform hand hygiene. Put on PPE (Personal Protective Equipment). ...5. Perform inspection, auscultation and palpation on entire length of access... ...12. For patient who have a documented allergy to povidone iodine or ExSept Plus, necessitating alcohol alone, apply alcohol using a circular motion, center out for 60 seconds and allow to air dry for 15 seconds prior to cannulation. 13. Do not palpate insertion site once area has been prepped. ...16. Remove gloves, perform hand hygiene and put on clean gloves prior to cannulation. 1. An observation of cleaning and disinfection of station 4 by Employee Identifier (EI) # 4, Patient Care Technician (PCT), was conducted on 1/9/24 at 10:26 AM. At 10:32 AM, EI # 4 emptied the trash and removed gloves and without performing hand hygiene, touched clean supplies that were on the counter at the nurse’s station. An interview was conducted on 1/11/24 at 10:00 AM with EI # 1, Facility Administrator (FA), who confirmed hand hygiene was not completed per facility policy. 39098 2. An observation of Access of AV Fistula or Graft for Initiation of Dialysis for PI # 11 was conducted on 1/9/24 at 12:07 PM with EI # 3, CCHT (Certified Clinical Hemodialysis Technician) at station 18. EI # 3 performed hand hygiene and donned clean gloves and began opening the supplies for the procedure. EI # 3 removed one glove, documented on the computer beside the dialysis machine, then dispensed hand sanitizer into the one ungloved hand, rubbed her/his fingers together, and donned a clean glove. EI # 3 failed to remove both gloves and perform hand hygiene. With gloved hands, EI # 3 palpated both cannulation sites, and then cleaned both insertion sites with one alcohol pad each, approximately 15 seconds each. PI # 11 had no documented allergy to povidone iodine or ExSept Plus antiseptics. EI # 3 failed to follow facility procedure and use appropriate skin antisepsis. EI # 3 wore the same contaminated gloves to palpate the sites, perform skin antisepsis, and then cannulation. An interview was conducted on 1/11/24 at 10:11 AM with EI # 1, who confirmed staff failed to perform skin antisepsis per procedure, and perform hand hygiene per policy. 3. An observation of Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft for PI # 7 was conducted on 1/9/24 at 10:10 AM at station 17. EI # 3 performed hand hygiene, donned clean gloves, and disconnected PI # 7 from the blood lines. EI # 3 discarded the tubing in the garbage, removed gloves and donned clean gloves. EI # 3 failed to perform hand hygiene after removing gloves. An interview was conducted on 1/11/24 at 10:11 AM with EI # 1, who confirmed staff failed to perform hand hygiene per policy.”

“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: 42144 Based on observations, facility procedure, and interview, it was determined the facility failed to ensure staff performed Central Venous Catheter (CVC) care per facility policy. This affected one of two observations for discontinuation of a CVC including Patient Identifier (PI) # 9 and one of two observations for initiation of dialysis with a CVC including PI # 4, and had the potential to negatively affect all patients with CVC’s who dialyze at the facility. Findings include: Facility Policy: Central Venous Catheter With Clearguard HD (Hemodialysis) Antimicrobial End Caps Procedure Procedure Number: 1-04-02B Revised Date: October 2023 Notes: ...Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason...Effective contact time, 15 seconds. Procedure ...16. Using aseptic technique. remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried. 1. An observation was conducted on 1/9/24 at 10:45 AM at station 6 with Employee Identifier (EI) # 5, Registered Nurse (RN), to observe CVC discontinuation on PI # 9. During the observation, EI # 5 scrubbed both CVC hubs with alcohol for 7 seconds each failing to clean each hub for 15 seconds per policy. An interview conducted on 1/11/24 at 9:45 AM with EI # 1, Facility Administrator confirmed staff failed to follow the facility procedure for cleaning the CVC hubs. 2. An observation was conducted on 1/9/24 at 11:30 AM with EI # 5 at station 3 to observe CVC initiation for PI # 4. During the observation, EI # 5 scrubbed the red CVC hub for 3 seconds, connected a syringe and withdrew blood, removed the syringe and scrubbed the red hub again for 2 seconds prior to flushing the CVC. EI # 5 failed to scrub the hub for 15 seconds per the facility procedure. EI # 5 then scrubbed the blue CVC hub for 3 seconds, connected a syringe to withdraw blood, removed the syringe and scrubbed the hub for 3 seconds prior to flushing the CVC. EI # 5 failed to scrub the hub for 15 seconds per facility procedure. After starting dialysis, EI # 5 clamped, disconnected and reversed the blood lines without recleaning the hubs. An interview conducted on 1/11/24 at 9:45 AM with EI # 1 confirmed staff failed to follow the facility procedure for cleaning the CVC hubs.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 39098 Based on observation, facility policy and procedure, and interview, it was determined the facility failed to ensure: 1. Staff performed total chlorine testing per policy, in one of one observations for total chlorine testing. 2. All staff whose duties included interpreting total chlorine testing had passed a color blindness test. This had the potential to affect all 47 patients dialyzing at this facility. Findings include: Facility Policy: Daily Water System Total Chlorine Monitoring Policy Number: 2-05-02 Date Revised: October 2023 Purpose: To establish that total chlorine testing is regularly performed... ...Policy: 1. Only trained teammates may perform daily water system total chlorine testing. 2. To verify that Chlorine and Chloramine levels are within limits... ...6. The following test kits/strips are approved... ...RPC (Brand) Ultra Low Total Chlorine Test Strip Facility Procedure: Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip. Procedure Number: 2-05-02H Date Revised: October 2023 ...Procedure ...3. Remove the strip and shake once, briskly, to remove excess water. ...5. After the 20 second wait period, immediately compare the strip color to the K 100-0118 color chart to determine the Total Chlorine level in the sample. An observation was conducted on 1/10/24 at 8:11 AM to observe Employee Identifier (EI) # 2, Registered Nurse, perform chlorine testing on the water system. After inserting the strip in the sample for 60 seconds, EI # 2 removed the strip and stated, “Now I shake the strip for 20 seconds.” The surveyor observed EI # 2 shake the testing strip for 20 seconds. EI # 2 failed to perform the test according to facility procedure. A review of EI # 2’s personnel file revealed a Teammate/Patient/Helper Color Vision Test Results form, dated 5/15/23. The form had not been graded and marked ‘Normal’ or ‘Color Vision Defect.’ The surveyor was unable to determine if EI # 2 was determined competent to interpret the color matching test results for chlorine testing. An interview was conducted on 1/10/24 at 3:50 PM, with EI # 1, Facility Administrator, who confirmed staff failed to follow facility procedure for testing total chlorine and further confirmed EI # 2’s vision test had not been graded. EI # 1 provided the surveyor with a copy of EI # 2’s graded form, which had been graded 1/10/24 and marked as ‘Normal.’”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 39098 Based on observations, facility policy, and interviews, it was determined staff failed to document refrigerator temperatures per policy. This had the potential to affect all patients dialyzing at this facility. Findings include: Facility Policy: Medications Requiring Refrigeration Policy number: 1-06-06 Date Revised: December 2022 Purpose: To provide guidance for the storage and management of medications requiring refrigeration . Policy: ...3. The refrigerator is checked during facility normal operating hours... a. Twice daily temperature checks located on the Digital Data Logger display, at the beginning and end of the day... During a tour of the treatment floor on 1/9/24 at 10:00 AM, the surveyor reviewed the temperature logs for the refrigerators on the floor. The following was observed: 1. Medication Refrigerator Management Log: December 2023 “Medication” Missing AM and PM temperatures on the following dates: 12/1/23 12/9/23 12/19/23 2. Medication Refrigerator Management Log: December 2023 “Freezer” Missing documentation on the following dates: 12/1/23 12/7/23 12/9/23 12/19/23 12/23/23 12/26/23 3. Medication Refrigerator Management Log: December 2023 “Lab” Missing AM and PM temperatures on the following dates: 12/1/23 12/9/23 12/19/23 Missing PM temperatures on the following dates: 12/15/23 12/23/23 12/24/23 An interview was conducted on 1/11/24 at 10:15 AM with Employee Identifier # 1, Facility Administrator, who confirmed staff failed to document temperatures per policy.”

“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: 39098 Based on review of medical records (MR), facility policy, and interviews with the staff, it was determined the facility failed to ensure: 1. Normal Saline (NS) used for prime and post treatment rinse was documented. 2. Blood pressure (BP), pulse rate and safety checks were performed and documented every 30 minutes per policy. 3. Pre and post treatment Estimated Dry Weight (EDW) was reported to physician if less than or greater than one kilogram (kg) from prescribed EDW. 4. The physician was notified for elevated pre, intra, and post-treatment BP. This deficient practice affected 6 of 6 hemodialysis records reviewed and did affect Patient Identifier (PI) # 7, PI # 1, PI # 4, PI # 2, PI # 5, and PI # 3, and had the potential to negatively affect all 47 hemodialysis patients dialyzing at this facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy Number: 1-03-08 Date Revised: October 2023 Purpose: To obtain and document baseline and ongoing information... Policy: 1. Patient data will be obtained and documented... a. Data collection includes... ...ii. Measurement of Blood Pressure... iii. Heart or pulse rate... iv. Patient weight... Intradialytic Data Collection/ Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT (Patient Care Technician) or licensed nurse includes: a. Vital signs and treatment monitoring i. For non-nocturnal treatments is completed at least every thirty (30) minutes... b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate ...iv. Fluid removal and/or replacement... 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... 12. The licensed nurse notifies the physician... as needed of changes in patient status. Abnormal Findings ...Pre-treatment: Any weight loss from last post weight... Post-treatment: If patient is above or below 1 kg from the target weight. Blood Pressure: Pre-dialysis: Systolic Blood Pressure (SBP) greater than ( >) 180 mm Hg (millimeters Mercury) or less than (<) 90 mm Hg Diastolic Blood Pressure (DBP) > or equal (=) to 100 mm Hg Blood Pressure-Intradialytic: Difference of 20 mm Hg increase or decrease from patient’s last intradialytic treatment BP reading. Blood Pressure Post Treatment: ...Standing SBP > 140 mm Hg or < 90 mm Hg Standing DBP > 90 mm Hg or < 50 mm Hg Sitting BP for patient’s that cannot stand: Sitting SBP > 140 mm Hg or < 90 mm Hg Sitting DBP > 90 mmHg or < 50 mm Hg 1. PI # 7 was admitted to the facility on 5/4/19 with a diagnosis of ESRD (End Stage Renal Disease). Review of the Treatment Detail Report (TDR) dated 12/23/23 revealed the PCT documented at 9:34 AM, “Normal saline prime given...” There was no documentation how much saline was administered. Review of the Dialysis Prescription dated 12/26/23 revealed an ordered EDW of 84 kg. Review of the TDR dated 12/26/23 revealed a pre-treatment weight of 81.5 kg, which was 2.5 kg below EDW. The was no documentation the physician was notified of the pre-treatment weight below EDW and below the last post-treatment weight of 85 kg, per policy. Further review of the TDR dated 12/26/23 revealed the PCT documented at 9:33 AM, “Normal saline prime given...” There was no documentation how much saline was administered. Further review of the TDR dated 12/26/23 revealed a VS (Vital Sign) and safety check at 9:33 AM. The next VS and safety check was at 10:35 AM, which was 62 minutes later, and not every 30 minutes per policy. Review of the post-treatment EDW on 12/26/23 was 81.0 kg. There was no documentation the physician was notified of the post-treatment weight, which was 4 kg below EDW. Review of the TDR dated 12/28/23 revealed the post-treatment EDW was 82.5 kg, which was 1.5 kg below the EDW. There was no documentation the physician was notified of the weight below EDW. Review of the TDR dated 1/9/24 revealed a VS and safety check at 8:32 AM. The next VS and safety check was documented at 9:32 AM, which was 60 minutes later, and not every 30 minutes per policy. An interview was conducted on 1/11/24 at 9:34 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed staff failed to document amount of prime fluids administered, VS and safety checks per policy, and also failed to notify the physician when the patient’s pre and post-treatment weight was less than or greater than 1 kg from the ordered EDW. 47295 2. PI # 1 was admitted to the facility on 4/30/19 with a diagnosis of ESRD. Review of the Dialysis Prescription dated 12/24/23 revealed an ordered EDW of 82 kg. Review of the TDR dated 12/24/23 revealed a post-treatment weight of 86.5 kg. There was no documentation the physician was notified of the post-treatment weight, which was 4.5 kg above EDW. Further review of the TDR dated 12/24/23 revealed PI # 1’s Pre-Treatment BP was 181/96 and the Post Treatment BP was 143/89. There was no documentation the physician was notified for pre-dialysis SBP > 180 or for post-dialysis sitting SBP > 140. Review of the TDR dated 12/27/23 revealed PI # 1’s Post-Treatment BP was 171/104. There was no documentation the physician was notified for post-dialysis sitting SBP > 140 or sitting DBP > 90. Review of the TDR dated 12/29/23 revealed PI # 1’s Post-Treatment BP was 166/87. There was no documentation the physician was notified for post-dialysis sitting SBP > 140. Review of the TDR dated 1/5/24 revealed a post-treatment weight of 86.2 kg. There was no documentation the physician was notified of the post-treatment weight, which was 4.2 kg above EDW. Further review of the TDR dated 1/5/24 revealed PI # 1’s pre-treatment BP was 185/116 and the post-treatment BP was 152/97. There was no documentation the physician was notified of pre-treatment SBP > 180 or DBP > 100. There was also no documentation the physician was notified of post-dialysis sitting SBP > 140 or sitting DBP > 90. Review of the TDR dated 1/8/24 revealed a post treatment weight of 85.7 kg. There was no documentation the physician was notified of the post-treatment weight, which was 3.7 kg above EDW. Further review of the TDR dated 1/8/24 revealed PI # 1’s post-treatment BP was 159/91. There was no documentation the physician was notified of post-dialysis sitting SBP > 140 or sitting DBP > 90. An interview was conducted on 1/11/24 at 9:23 AM with EI # 1, who confirmed staff failed to notify the physician per policy for elevated BPs and post-treatment weights greater than 1 kg from EDW. 3. PI # 4 was admitted to the facility on 5/15/23 with an admitting diagnosis of ESRD. Review of the Dialysis Prescription dated 12/27/23 revealed an ordered EDW of 96 kg. Review of the TDR dated 12/27/23 revealed a pre-treatment weight of 94.7 kg, which was 1.3 kg below EDW. There was no documentation the physician was notified of the pre-treatment weight below EDW and below the last post-treatment weight of 95.1 kg, per policy. Further review of the TDR dated 12/27/23 revealed a post-treatment weight of 92.8 kg. There was no documentation the physician was notified of the post-treatment weight, which was 3.2 kg below EDW. Review of the TDR dated 12/29/23 revealed a post-treatment weight of 94.9 kg. There was no documentation the physician was notified of the post-treatment weight, which was 1.1 kg below EDW. Review of the TDR dated 1/1/24 revealed a pre-treatment weight of 94.6 kg, which was 1.4 kg below EDW. There was no documentation the physician was notified of the pre-treatment weight below EDW and below the last post-treatment weight of 94.9 kg, per policy. Further review of the TDR dated 1/1/24 revealed a post-treatment weight of 94.1 kg. There was no documentation the physician was notified of the post-treatment weight, which was 1.9 kg below EDW. Review of the TDR dated 1/3/24 revealed a post-treatment weight of 99.5 kg. There was no documentation the physician was notified of the post-treatment weight, which was 3.5 kg above EDW. Review of the TDR dated 1/5/24 revealed a post-treatment weight of 99.5 kg. There was no documentation the physician was notified of the post-treatment weight, which was 3.5 kg above EDW. An interview was conducted on 1/11/24 with EI # 1, who confirmed staff failed to notify the physician per policy for pre-treatment weights less than the last treatment’s post weight and for post-treatment weights greater than 1 kg from the EDW. 42144 4. PI # 2 was transferred to the facility on 12/19/23 with a diagnosis of ESRD. Review of the physician medication order dated 12/18/23 revealed an order for Clonidine 0.2 mg (milligram) oral every hour as needed with provider instructions as follows: “Administer 0.2 mg PO (by mouth) for systolic greater than 200 and in one hour if BP still greater than 200 systolic then repeat the 0.2 mg. Call MD if no decrease after the second dose.” Review of the TDR dated 12/19/23 at 11:19 AM revealed a systolic BP of 221 and Clonidine 0.2 mg was given at 11:30 AM at the beginning of treatment. At 2:00 PM, the patient complained of a headache, systolic BP 223 and the RN (Registered Nurse) documented very little symptom improvement and a second dose of Clonidine 0.2 mg was given. At 3:10 PM, the RN documented treatment was terminated and the systolic BP was 229. There was no documentation the physician was notified the systolic BP remained greater than 200 after the second dose of Clonidine as ordered. Review of the TDR dated 12/21/23 at 11:08 AM revealed 200 ml NS prime given and a systolic BP of 238 at the beginning of treatment. The RN documented, Clonidine 0.2 mg given at 12:00 PM. At 1:00 PM, the systolic BP was 214 and a second dose of Clonidine 0.2 mg given. The RN documented a systolic BP of 226 at 2:31 PM. There was no documentation the physician was notified the systolic BP remained greater than 200 after the second dose of Clonidine as ordered and no documentation of rinseback at the end of treatment. Further review of the TDR dated 12/21/23 revealed a target weight of 58.1 kg and a post treatment weight of 59.2 kg. There was no documentation the physician was notified the post treatment weight was greater than 1 kg per policy. Review of the TDR dated 12/23/23 at 11:30 AM revealed a systolic BP of 226 at the beginning of treatment. At 12:32 PM, the RN documented the systolic BP continued to be elevated at 202 and the patient declined to take Clonidine. At 1:04 PM, the RN documented a systolic BP of 208 and the patient continued to decline to take Clonidine. At 2:27 PM, the patient requested Tylenol for a headache, refused Clonidine and 650 mg of Tylenol was administered. There was no documentation the physician was notified the patient refused Clonidine for the elevated systolic BP. At 2:40 PM, the RN documented the patient requested to end treatment early and left AMA (Against Medical Advice). Review of the TDR dated 1/4/24 at 11:07 revealed a systolic BP of 209 and 200 mg of NS prime was administered by the PCT at the beginning of treatment. Further review revealed at 12:10 PM, 200 mg of NS prime was administered by the RN. There was no documentation the patient was administered Clonidine for the systolic BP greater than 200, why the NS prime was repeated and no documentation the physician was notified. Further review of the TDR dated 1/4/24 at 12:30 PM revealed PI # 2’s systolic BP was 205 and Clonidine 0.2 mg was administered. At 1:31, PM, the PCT documented a systolic BP of 229. There was no documentation Clonidine 0.2 mg was repeated after one hour when the systolic remained greater than 200. At 2:14 PM, the RN documented PI # 2 complained of a severe headache and treatment was terminated. An interview conducted on 1/11/24 at 9:45 AM with EI # 1 confirmed the staff failed to follow the physician’s orders and administer Clonidine every hour for systolic BP greater than 200 and failed to notify the physician when the systolic BP remained greater than 200 after the second dose of Clonidine and the EDW was greater than 1 kg over the target weight. EI # 1 also confirmed the staff failed to document why a prime of normal saline was documented as administered twice for one treatment and failed to document rinseback at the end of a treatment. 5. PI # 5 was admitted to the facility on 10/13/10 with a diagnosis of ESRD. Review of the TDR dated 12/28/23 revealed a target weight of 73.5 kg and a post treatment weight of 75.1 kg. There was no documentation the physician was notified the post treatment weight was greater than 1 kg above the target weight. An interview conducted on 1/11/24 at 9:45 AM with EI # 1 confirmed there was no documentation the staff notified the physician the post treatment weight was greater than 1 kg above the target weight. 49603 6. PI # 3 was admitted to the facility on 12/05/23 with a diagnosis of ESRD. Review of the TDR dated 12/26/23 revealed an ordered target EDW of 71.5 kg, and post treatment weight of 74.4 kg. There was no documentation the physician was notified of the post-treatment weight 2.9 kg over target EDW. Review of the TDR dated 12/28/23 revealed an ordered target EDW of 71.5 kg, and post treatment weight of 74.5 kg. There was no documentation the physician was notified of the post-treatment weight 3.0 kg over target EDW. Review of the TDR dated 1/06/24 revealed an ordered target EDW of 71.5 kg, and post treatment weight of 73.9 kg. There was no documentation the physician was notified of the post-treatment weight 2.4 kg over target EDW. An interview was conducted on 1/11/24 at 9:18 AM with EI # 1, who confirmed staff failed to notify MD of post weight greater than 1.0 kg over target EDW per facility policy.”

“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: 47295 Based on review of Medical Records (MR), policies, and staff interviews, it was determined the facility failed to ensure: 1. The staff followed the physician’s orders for Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR). 2. The staff had patients sign the Early Termination of Treatment Against Medical Advice (AMA) Form when treatment was terminated early. This deficient practice affected six of six in-center hemodialysis (ICHD) records reviewed and did include PI # 1, PI # 4, PI # 2, PI # 5, PI # 3, and PI # 7, and had the potential to negatively affect all 47 ICHD patients who dialyzed at this facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Policy Number: 1-03-08 Revision Date: 10/2023 Purpose: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment... Policy: ...3. Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment with the exception of BFR which is verified and documented when the ordered rate is obtained after onset of treatment... Intradialytic Data Collection/Assessment: ...9. At a minimum, obtain and document the following: ...iii. Blood and dialysate flows... ...10. If the dialysis prescription is not being met (including DFR or change to/inability to obtain prescribed BFR) the reason will be documented and the licensed nurse informed. Facility Policy: Prescribed Treatment Time Not Met Policy Number: 1-01-09 Revision Date: 10/2023 Purpose: To provide requirements for teammates to follow when a patient’s treatment is terminated early. Policy: A. Completion of the Early Termination of Treatment Against Medical Advice Form 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time... B. Prescribed Treatment Time Not Met 1. 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... 1. Patient Identifier (PI) # 1 was admitted to the facility on 4/30/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Dialysis Prescription revealed hemodialysis treatment orders dated 12/24/23 with a BFR of 400 and a DFR of 800. Review of the Treatment Details Report (TDR) dated 12/24/23 revealed the DFR ran at 500 from 11:04 AM to 1:03 PM. There was no documentation why the DFR was not at the ordered rate of 800. Review of the TDR dated 12/27/23 revealed the BFR rate was 0 at 10:33 AM, was increased to 260 at 11:03 AM, then decreased to 200 at 12:03 PM. There was no documentation why the BFR was not at the ordered rate of 400. Review of the TDR dated 12/29/23 revealed the BFR rate was 300 at 10:15 AM, was decreased to 250 at 10:31 AM, decreased to 0 at 11:00 AM, and then increased to 200 from 11:31 AM to 12:31 PM. The DFR rate was 500 from 10:14 AM to 12:31 PM. There was no documentation why the BFR was not at the ordered rate of 400 or why the DFR was not at the ordered rate of 800. Further review of the TDR dated 12/29/23 revealed a prescribed treatment time of 225 minutes and completed treatment time of 137 minutes. There was no documentation that an AMA form was signed or that the physician was notified of an early termination of treatment time exceeding 30 minutes. Review of the TDR dated 1/3/24 revealed the BFR rate was 300 at 10:14 AM, was decreased to 220 at 11:01 AM, and then decreased to 200 at 2:01 PM. There was no documentation why the BFR was not at the ordered rate of 400. Review of the TDR dated 1/5/24 revealed the BFR rate was 350 at 10:17 AM then decreased to 300 at 10:31 AM until treatment ended at 2:01 PM. There was no documentation why the BFR was not at the ordered rate of 400. Review of the TDR dated 1/8/24 revealed the BFR ran the entire treatment from 10:13 AM to 2:17 PM at 300. There was no documentation why the BFR was not at the ordered rate of 400. An interview was conducted on 1/11/24 at 9:23 AM with Employee Identifier (EI) # 1, Facility Administrator (FA), who confirmed staff failed to follow orders for BFR and DFR and failed to follow facility policy for early treatment termination. 2. PI # 4 was admitted to the facility on 5/15/23 with a diagnosis of ESRD. Review of the Dialysis Prescription revealed hemodialysis treatment orders dated 12/22/23 with a BFR of 350 and DFR of 500. Review of the TDR dated 12/22/23 revealed the BFR rate was 300 from 11:31 AM until treatment ended at 2:33 PM. There was no documentation why the BFR was not at the ordered rate of 350. Review of the TDR dated 12/29/23 revealed the BFR rate was 300 from 11:31 AM until 2:04 PM. There was no documentation why the BFR was not at the ordered rate of 350. An interview was conducted on 1/11/24 at 9:41 AM with EI # 1, who confirmed staff failed to follow orders for BFR. 42144 3. PI # 2 was transferred to the facility on 12/19/23 with a diagnosis of ESRD. Review of the Dialysis prescription dated 12/23/23 revealed an ordered treatment time of four hours. Review of the TDR dated 12/23/23 at 2:40 PM revealed, “treatment terminated, patient request to end treatment early” which was 51 minutes earlier than the prescribed run time. There was no documentation the patient signed or refused to sign the AMA form and no documentation the physician was notified. An interview conducted on 1/11/24 at 9:45 AM with EI # 1 confirmed the staff failed to follow the policy and there was no documentation an Early Termination of Treatment Against Medical Advice form was signed or refused and staff failed to notify the physician. 4. PI # 5 was admitted to the facility on 10/13/2010 with a diagnosis of ESRD. Review of the TDR dated 12/28/23 revealed a dialysis order for DFR 800 ml/min. Further review of the TDR dated 12/28/23 revealed the DFR was run at 500 instead of 800 as ordered and continued to run at 500 from the beginning of treatment at 5:25 AM until the treatment terminated at 9:16 AM. There was no documentation of why the DFR was not run at the ordered rate of 800. An interview conducted on 1/11/24 at 9:45 AM with EI # 1 confirmed the staff failed to follow the policy and there was no documentation of why the DFR was run at 500 instead of 800 as ordered. 49603 5. PI #3 was admitted to the facility on 12/05/2023 with a diagnosis of ESRD. Review of the TDR dated 12/26/23 revealed an ordered BFR of 450. Further review revealed the BFR ran the entire treatment from 11:04 AM to 2:03 PM at 350. There was no reason documented why the BFR was 350 and not at 450 as ordered. Further review of the TDR dated 12/26/23 revealed a prescribed treatment time of 225 minutes and completed treatment time of 137 minutes. There was no documentation that an Early Termination of Treatment AMA form was signed or that the physician was notified of an early termination of treatment time exceeding 30 minutes. Review of the TDR dated 12/28/23 revealed a prescribed treatment time of 225 minutes and completed treatment time of 163 minutes. There was no documentation that an Early Termination of Treatment AMA form was signed or that the physician was notified of an early termination of treatment time exceeding 30 minutes. Review of the TDR dated 12/30/23 revealed an ordered BFR of 450. Further review revealed the BFR ran the entire treatment from 11:21 AM to 1:44 PM at 350. There was no reason documented why the BFR was 350 and not at 450 as ordered. Further review of the TDR dated 12/30/23 revealed a prescribed treatment time of 225 minutes and completed treatment time of 181 minutes. There was no documentation that an Early Termination of Treatment AMA form was signed or that the physician was notified of an early termination of treatment time exceeding 30 minutes. Review of the TDR dated 1/04/24 revealed an ordered BFR of 450. Further review revealed the BFR ran at 200 at 11:37 AM, increased to 350 from 12:01 PM to 2:31 PM , then decreased to 200 at 2:40 PM end of treatment. There was no reason documented why the BFR was 200 or 350 and not at 450 as ordered. Further review of the TDR dated 1/04/24 revealed a prescribed treatment time of 225 minutes and completed treatment time of 181 minutes. There was no documentation that an Early Termination of Treatment AMA form was signed or that the physician was notified of an early termination of treatment time exceeding 30 minutes. Review of the TDR dated 1/06/24 revealed a prescribed treatment time of 225 minutes and completed treatment time of 182 minutes. There was no documentation that an Early Termination of Treatment AMA form was signed or that the physician was notified of an early termination of treatment time exceeding 30 minutes. An interview was conducted on 1/11/24 at 9:18 AM with EI # 1 who confirmed the staff failed to document why the BFR was not at the 450 ordered rate and confirmed the staff failed to document early treatment termination, complete AMA form and notify physician of early termination of treatment time exceeding 30 minutes. 39098 6. PI # 7 was admitted to the facility on 5/4/19 with a diagnosis of ESRD. Review of the Patient Summary Report printed 1/9/24 revealed active treatment orders of BFR 450, and DFR 500. Review of the TDR dated 12/26/23 revealed the BFR was 400 from 9:33 AM start of treatment to 1:30 PM end of treatment. There was no documentation why the BFR was not 450 as ordered. Review of the TDR dated 12/30/23 revealed the BFR was 450 at treatment start until 10:32 AM, then decreased to 400 until 11:01 AM, then decreased to 300 until end of treatment at 1:01 PM. There was no documentation why the BFR was not 450 as ordered. Review of the TDR dated 1/4/24 revealed the BFR was 450 at start of treatment, then decreased to 400 at 1:03 PM to end of treatment at 2:21 PM. There was no documentation why the BFR was not 450 as ordered. Further review of the TDR dated 1/4/24 revealed the DFR was 500 from start of treatment at 10:33 AM until 1:03 PM, then increased to 800 until end of treatment at 2:21 PM. There was no documentation why the DFR was not 500 as ordered. Review of the TDR dated 1/9/24 revealed the BFR was run at 400 the entire treatment from 6:06 AM to 10:06 AM. There was no documentation why the BFR was not at the ordered rate of 450. An interview was conducted on 1/11/24 at 9:34 AM with EI # 1, who confirmed staff failed to follow physician’s orders for BFR and DFR.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 39098 Based on observations, facility policy, and interview, it was determined the facility failed to ensure staff followed the policy for incident/event reporting. This included two incidents/events affecting Patient Identifier (PI) # 7, one of four patient care observations conducted to verify the patient’s prescription during the flash tour, and had the potential to negatively affect all 47 patients who dialyze at the facility. Findings Include: Facility Policy: Risk Event Reporting Policy Policy Number: 13-01-02 Revised Date: July 2023 Purpose: To establish the process for handling and investigating Risk Event Management (REM) Reports. Policy: 1. Any unexpected event that is inconsistent with the... routine provision of acute dialysis... 2. All risk events will be promptly reported to the Facility Administrator... The teammate involved in the risk event... will complete a REM report. The teammate will complete the REM report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened. ...B. ...2. If the risk event involves a patient, the Facility Administrator... will notify... the patient’s attending physician/nephrologist and the facility Medical Director... Exhibit A Examples of Reportable Risk Events ...Dialysate Concentrate Issue ...Medication Error 1. During the flash tour of the facility and observations of patient care on 1/9/24 at 10:00 AM the surveyor asked Employee Identifier (EI) # 3, Certified Clinical Hemodialysis Technician, to verify the dialysis prescription for PI # 7 at station 17. The dialysis prescription revealed the ordered dialysate of 3.0 K (potassium)/2.5 Ca (Calcium). PI # 7 was currently dialyzing and the dialysis machine was connected to the wall plumbing, which delivered a 2.0 K/2.5 Ca dialysate. The surveyor asked EI # 3 if the patient was receiving the correct dialysate, and EI # 3 responded, “No, his/her jug (a container with dialysate concentrations different than the plumbed dialysate) ran out, and we connected PI # 7 to the wall to finish his/her dialysis.” EI # 3 confirmed PI # 7 was not dialyzing with the correct dialysate. On a cart in the back of the treatment floor, the surveyor observed multiple jugs containing the ordered 3.0 K/2.5 Ca dialysate. At 10:10 AM the surveyor observed EI # 3 disconnect PI # 7 from the dialysis machine, and exit the treatment floor. The surveyor observed a 250 cc (cubic centimeter) IV (Intravenous) bag with fluid remaining in the bag, still hanging on the dialysis machine IV pole. The surveyor asked EI # 3 what was in the bag. EI # 3 retrieved the bag from the pole and showed the surveyor it contained 1 Gm (Gram) of Vancomycin, with 150 cc remaining in the bag. The surveyor asked EI # 3 if PI # 7 should have received all of the Vancomycin. EI # 3 stated, “Yes.” An interview was conducted on 1/11/24 at 9:34 AM with EI # 1, Facility Administrator. The surveyor asked EI # 1 if two adverse/ incident reports were documented by the staff for the incorrect dialysate and medication error, and reported to the physician. EI # 1 stated staff failed to report and record two patient safety events as directed per facility policy. EI # 1 further stated the staff failed to notify the physician as directed per the facility policy.”

“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: 49603 Based on review of medical records (MR), facility policy, and interview, it was determined the Medical Director failed to ensure the Registered Nurse (RN) followed the facility policies and performed and documented an initial nurse assessment evaluation prior to initiation of the first in-center dialysis treatment, which did affect Patient Identifier (PI) # 3, in one of one in-center new patient record reviews. This had the potential to negatively affect all patients admitted to this facility. Findings include: Facility Policy: CWOW (Centers Without Walls)- Initial Nursing Assessment for New Patients Policy Number: 1-03-07 Revision Date: October 2021 ...Purpose: To provide guidance for all new patients to be evaluated by a RN prior to the initiation of their first treatment at the facility. Policy: 1. A RN as required by federal regulation will perform an initial pre-treatment evaluation of all new patients prior to initiation of their first treatment at the facility. ...4. This initial pre-treatment evaluation will be documented ... as the Initial Patient Nursing Assessment... 1. PI # 3 was admitted to the facility on 12/5/23 with a primary diagnosis of ESRD (End Stage Renal Disease). Review of the Treatment Details Report dated 12/5/23 revealed the initial facility dialysis treatment started at 11:50 AM, the pre-treatment assessment was completed at 12:48 PM, and the initial patient nursing assessment was completed on 12/5/23 at 12:00 PM, which was 10 minutes after the initial dialysis treatment start time. An interview was conducted on 1/11/24 at 9:18 AM with EI (Employee Identifier) # 1, Facility Administrator, who confirmed staff failed to document initial RN assessment findings prior to the initial dialysis treatment initiation.”