Rai - Parallel Parkway - Kansas City Dialysis

“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: 35949 Based on observation, interview, and facility policy review, the facility failed to ensure 2 (Certified Clinical Hemodialysis Technicians [CCHT] 6 and 9) of 2 observed staff performed hand hygiene before they touched patient care equipment (dialysis machine), before they touched patient care supplies, after removal of gloves, and before patient contact. Failure to perform hand hygiene provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 79 patients who received dialysis treatments and/or home therapy oversight at the facility. Findings Include: A facility policy titled, “Hand Hygiene,” published 11/06/23, indicated, “The table below identifies when hands shall be washed specifically with soap and water or when alcohol-based hand rubs can be used.” In part, the table indicated, hands will be “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water. Before and after direct contact with patients” and “immediately after removing gloves.” Observations of the dialysis treatment area on 10/09/24 with the Clinical Manager (CM) revealed the following: At 11:55 AM, CCHT 6 obtained and applied a previously used personal protective equipment (PPE) gown. CCHT 6 obtained and applied a pair of gloves, entered Station 17, and touched the dialysis machine. At 12:15 PM, at the nurses’ station, CCHT 6 opened the supply storage drawers with gloved hands. CCHT 6 exited the nurses’ station, entered Station 15, and touched the dialysis machine. CCHT 6 exited the station, removed their pair of gloves, and obtained a patient care supply from the clean storage area. During an interview on 10/098/24 at 12:25 PM, CCHT 6 acknowledged he did not perform hand hygiene after he removed gloves and before he touched the patient care equipment and supplies. CCHT 6 confirmed he was trained and expected to perform hand hygiene after removal of gloves and before he touched patient care equipment and supplies. At 3:10 PM, in Station 5, CCHT 9 wore a pair of gloves. CCHT 9 exited the station and removed the pair of gloves. CCHT 9 obtained and applied a new pair of gloves, re-entered Station 5, and touched Patient 9. At 3:55 PM, CCHT 9 opened the supplies storage drawers near the nurses’ station while she held a pair of gloves in her right hand. CCHT 9 entered Station 8, applied the held pair of gloves, and touched the dialysis machine. At 4:15 PM, CCHT 9 obtained a pair of gloves and touched her PPE face shield while she held the pair of gloves in her hand. CCHT 9 entered Station 7, applied the held gloves, and touched Patient 10. During an interview on 10/09/24 at 12:20 PM, the CM confirmed staff were trained and expected to perform hand hygiene after they removed gloves, before they touched patient care equipment, before they touched patient care supplies, and before patient contact. During an interview on 10/09/24 at 5:38 PM, CCHT 9 confirmed she was trained and expected to perform hand hygiene after removal of gloves, before she touched patient care equipment, and before patient contact. During an interview on 10/10/24 at 10:20 AM, the Medical Director confirmed staff should perform hand hygiene after removal of gloves and before they touched patient care equipment.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 35949 Based on observation, interview, manufacturer’s directions for use (DFU) review, and procedure review, the facility failed to prevent inaccurate arterial and venous pressure readings and possible blood cross contamination by not immediately removing the external transducer protector (TP - a filter which helped prevent the passage of bacteria, viruses, particulate matter, and fluid/blood to the dialysis machine by way of the arterial and venous pressure ports) when they became wetted with blood or other fluid, and by not inspecting the machine side of a wetted external TP for visible fluid and/or blood, during 1 of 1 observations. Failure to immediately remove a wetted external TP and inspect the machine side, had the potential to cause inaccurate pressure readings and possible contamination of the dialysis machine’s transducer component and the potential to expose the 67 in-center patients to blood borne pathogens. Findings Include: A facility procedure titled, “Maintenance of Transducer Protectors Procedure,” published 11/01/21, indicated, “External transducer protectors must be changed immediately when they become wet with blood or other fluid. Wet external transducer protectors must be thoroughly examined to determine if any blood or other fluid contamination is visible on the machine side (back) of the transducer protector prior to replacement. If no evidence of blood or fluid contamination is evident, no further action is required other than replacing the wet transducer. If the machine side (back) of the external transducer protector shows evidence of contamination with blood or other fluid; the machine must NOT be used to dialyze another patient until it has been thoroughly examined for any internal evidence of blood or fluid contamination by Technical Services.” The manufacturer’s DFU titled, “Combiset True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protector Instructions for Use,” indicated, “If fluid is visible on the side of the TP [transducer protector] that faces the machine, have qualified personnel open the machine and check for contamination after the treatment is completed. If contamination has occurred, the machine must be taken out of service and disinfected before further use according to manufacturer recommendations.” Observation on 10/07/24 at 11:10 AM during the environmental tour, revealed a wetted external TP on the venous pressure port of the dialysis machine located in Station 12. Observation on 10/07/24 at 11:25 AM with the Clinical Manager, revealed a wetted external TP on the venous pressure port of the dialysis machine located in Station 12. During a concurrent observation and interview on 10/07/24 at 11:30 AM, Certified Clinical Hemodialysis Technician (CCHT) 5 terminated a dialysis treatment in Station 12. CCHT 5 removed the used bloodlines and wetted TP from the machine and approached the biohazard bin to discard the used bloodlines and wetted TP. CCHT 5 acknowledged that the machine side of the TP was not visualized after removal. CCHT 5 stated she was “not sure” if she had been trained to visualize the machine side of the TP when wetted with blood or fluid after removal from the machine. During an interview on 10/07/24 at 11:33 AM, the Clinical Manager confirmed staff were trained and expected to remove wetted transducer protectors immediately, and to visualize the machine side after removal from the machine. During an interview on 10/10/24 at 10:20 AM, the Medical Director confirmed staff were expected to immediately change a TP when wetted and to visualize the machine side after removal from the machine.”

“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: 35949 Based on observation, interview, manufacturer’s directions for use (DFU) review, and facility procedure review, the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the arterial drip chamber fluid levels at 85% - 95% full and the venous drip chamber fluid levels at 65% - 75% full during 3 of 3 observations. Failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 67 patients who received in-center dialysis treatments at the facility. Findings Include: A facility procedure titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 06/28/24, indicated, “Fill the Pre-pump arterial chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 85% - 95% full and tighten cap.” Further review indicated, “Fill the venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75% full.” The manufacturer’s DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” indicated, “During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 10/07/24 at 11:10 AM, revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 3, 5, 6, 9, 10, 12, 13, 15, 16, and 17, and the venous drip chamber fluid levels were greater than (>) 75% full in Stations 2, 3, 5, 6, 9, 10, 12, 13, 15, 16, and 17. Observation of the hemodialysis treatment area on 10/07/24 at 11:25 AM with the Clinical Manager (CM), revealed the arterial drip chamber fluid levels were < 85% full in Stations 3, 6, 9, 10, 13, 14, 15, 16, and 17, and the venous drip chamber fluid levels were > 75% full in Stations 2, 3, 6, 9, 10, 13, 14, 15, 16, and 17. Observation of the hemodialysis treatment area on 10/09/24 at 11:20 AM, revealed the arterial drip chamber fluid levels were < 85% full in Stations 4, 6, 10, 11, 14, 15, and 16, and the venous drip chamber fluid levels were > 75% full in Stations 2, 4, 6, 10, 11, 14, 15, and 16. During an interview on 10/07/24 at 11:33 AM, the CM reviewed the manufacturer’s DFU and acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 10/09/24 at 5:38 PM, Certified Clinical Hemodialysis Technician 9 stated the arterial chamber was to be filled “darn near full” and she was unable to recall the percentage fill level for the venous chamber. During an interview on 10/10/24 at 10:20 AM, the Medical Director confirmed the staff were expected to follow the manufacturer’s DFU.”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to follow the individualized dialysis prescription as prescribed by the medical provider for 3 (Patients 1, 3, and 4) of 4 sampled in-center patients. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 67 in-center patients who received dialysis treatments at the facility. Findings Include: A facility policy titled, “Patient Assessment and Monitoring,” published 05/01/23, indicated, “Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet the prescribed blood flow. Check the dialysate flow rate setting is correct, and the prescribed flow rate is being delivered.” A facility policy titled, “Physician Order Documentation,” published 07/03/23, indicated, “Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders.” Patient 1 Patient 1’s treatment sheet, dated 09/19/24, revealed a prescribed dialysate flow rate (DFR) of 600 milliliters per minute (mL/min). Patient 1’s DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient 1’s treatment sheet, dated 09/21/24, revealed a prescribed DFR of 600 mL/min. Patient 1’s DFR was documented as 800 mL/min from 2:30 PM until 3:01 PM. There was no rationale documented why the prescribed DFR was not achieved. Patient 1’s treatment sheet, dated 09/24/24, revealed a prescribed DFR of 600 mL/min. Patient 1’s DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient 1’s treatment sheet, dated 09/26/24, revealed a prescribed blood flow rate (BFR) of 400 mL/min and a prescribed DFR of 600 mL/min. Patient 1’s BFR was documented as 420 mL/min from 2:30 PM until 3:03 PM and the DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient 1’s treatment sheet, dated 09/28/24, revealed a prescribed DFR of 600 mL/min. Patient 1’s DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient 1’s treatment sheet, dated 10/01/24, revealed a prescribed BFR of 400 mL/min and a prescribed DFR of 600 mL/min. Patient 1’s BFR was documented as 420 mL/min from 2:30 PM until 3:03 PM and the DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient 1’s treatment sheet, dated 10/03/24, revealed a prescribed DFR of 600 mL/min. Patient 1’s DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient 1’s treatment sheet, dated 10/05/24, revealed a prescribed BFR of 400 mL/min and a prescribed DFR of 600 mL/min. Patient 1’s BFR was documented as 350 mL/min from 3:36 PM until the treatment was terminated at 4:04 PM and the DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient 3 Patient 3’s treatment sheet, dated 09/18/24, revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Patient 3’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient 3’s treatment sheet, dated 09/27/24, revealed a prescribed BFR of 450 mL/min. Patient 3’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient 3’s treatment sheet, dated 09/30/24, revealed a prescribed BFR of 450 mL/min. Patient 3’s BFR was documented as 250 mL/min from 12:07 PM until 1:38 PM and 400 mL/min from 1:38 PM until the treatment was terminated at 2:39 PM. There was no rationale documented why the prescribed BFR was not achieved. Patient 3’s treatment sheet, dated 10/04/24, revealed a prescribed BFR of 450 mL/min. Patient 3’s BFR was documented as 300 mL/min from 12:04 PM until 1:33 PM and 400 mL/min from 1:33 PM until the treatment as terminated at 3:09 PM. There was no rationale documented why the prescribed BFR was not achieved. Patient 4 Patient 4’s treatment sheet, dated 09/20/24, revealed a prescribed blood flow rate (BFR) of 500 milliliters per minute (mL/min). Patient 4’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient 4’s treatment sheet, dated 09/23/24, revealed a prescribed BFR of 500 mL/min. Patient 4’s BFR was documented as 400 mL/min from 8:05 AM until 9:02 AM. There was no rationale documented why the prescribed BFR was not achieved. Patient 4’s treatment sheet, dated 09/25/24, revealed a prescribed dialysate flow rate (DFR) of 600 mL/min. Patient 4’s DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. Patient 4’s treatment sheet, dated 09/27/24, revealed a prescribed BFR of 500 mL/min. Patient 4’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient 4’s treatment sheet, dated 10/02/24, revealed a prescribed BFR of 500 mL/min. Patient 4’s BFR was documented as 300 mL/min from 7:45 AM until 9:30 AM. There was no rationale documented why the prescribed BFR was not achieved. Patient 4’s treatment sheet, dated 10/04/24, revealed a prescribed BFR of 500 mL/min. Patient 4’s BFR was documented between 400 mL/min and 450 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient 4’s treatment sheet, dated 10/07/24, revealed a prescribed BFR of 500 mL/min. Patient 4’s BFR was documented as 450 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. During an interview on 10/09/24 at 4:07 PM, the Clinical Manager stated staff were trained and expected to follow the physicians’ orders and document rationales when the prescribed BFR and/or DFRs were not achieved. During an interview on 10/09/24 at 5:38 PM, Certified Clinical Hemodialysis Technician 9 stated additional documentation was required if changes were made to a patient’s prescription. During an interview on 10/10/24 at 10:20 AM, the Medical Director stated staff were expected to follow the physicians’ orders and document reasons for any changes to the prescribed BFR and/or DFRs.”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to complete an initial comprehensive assessment conducted by all members of the interdisciplinary team (IDT - a registered nurse, a physician who treated the patient for end stage renal disease, a social worker, and a dietitian [Registered Dietician (RD)] within 30 calendar days or 13 treatments after admission, for 1 (Patient 1) of 1 sampled in-center patients new to dialysis and admitted to the facility within the last 90 days. Failure to complete an initial comprehensive assessment performed by all members of the IDT within 30 calendar days or 13 treatments after admission for patients new to dialysis provided opportunities for areas of concern to be unidentified and left unaddressed related to the patients’ plan of care and had the potential to negatively impact the care and well-being of the 67 in-center patients who received dialysis treatments at the facility. Findings Include: A facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” published 07/03/23, indicated, “An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.” A “Hemodialysis Treatment” log revealed Patient 1’s first dialysis treatment at the facility was performed on 09/07/24 and the 13th treatment was performed on 10/05/24. During an interview on 10/08/24 at 1:10 PM, the Clinical Manager confirmed no initial comprehensive assessment was completed by a RD for Patient 1 within 30 days and/or 13 treatments. During a follow-up interview on 10/08/24 at 1:52 PM, the CM stated the facility’s former RD vacated the position “prior to May [2024]” and a “regional” RD was responsible for the completion of assessments until the position was filled. The CM confirmed the expectation was to complete an initial comprehensive assessment for new patients within “the first 30 days or 13 treatments.” During an interview on 10/10/24 at 10:20 AM, the Medical Director confirmed the staff were expected to complete the initial comprehensive assessment on newly admitted patients new to dialysis within 30 days and/or 13 treatments of the admission date.”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to monitor patients’ vital signs and/or machine parameters according to their policy for 3 (Patients 1, 3, and 4) of 4 sampled in-center patients. Failure to monitor patients’ vitals and machine parameters according to the facility’s policy provided an opportunity for changes to the patients’ condition during dialysis treatments to be unrecognized and unaddressed and negatively impact the care provided to the 67 in-center patients who received dialysis treatments at the facility. Findings Include: A facility policy titled, “Patient Assessment and Monitoring,” published 05/01/23, indicated, “During Treatment ? Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. ? Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations.” Patient 1 Patient 1’s treatment sheet, dated 09/17/24, revealed monitoring was not documented for 59 minutes, from 12:35 PM until 1:34 PM. Patient 1’s treatment sheet, dated 09/24/24, revealed monitoring was not documented for 58 minutes, from 2:08 PM until 3:06 PM. Patient 3 Patient 3’s treatment sheet, dated 09/18/24, revealed monitoring was not documented for 54 minutes, from 11:43 AM until 12:37 PM and for 60 minutes, from 1:32 PM until 2:32 PM. Patient 3’s treatment sheet, dated 09/20/24, revealed monitoring was not documented for 50 minutes, from 11:33 AM until 12:23 PM. Patient 3’s treatment sheet, dated 09/23/24, revealed monitoring was not documented for 55 minutes, from 2:08 PM until 3:03 PM. Patient 3’s treatment sheet, dated 09/27/24, revealed monitoring was not documented for 64 minutes, from 11:30 AM until 12:34 PM. Patient 3’s treatment sheet, dated 10/02/24, revealed monitoring was not documented for 57 minutes, from 12:35 PM until 1:32 PM. Patient 4 Patient 4’s treatment sheet, dated 09/20/24, revealed monitoring was not documented for 89 minutes, from 9:31 AM until 11:00 AM. Patient 4’s treatment sheet, dated 10/02/24, revealed monitoring was not documented for 97 minutes, from 9:30 AM until 11:07 AM. During an interview on 10/09/24 at 4:07 PM, the Clinical Manager stated staff were expected to monitor patients every 30 minutes. During an interview on 10/09/24 at 5:38 PM, Certified Clinical Hemodialysis Technician 9 stated staff were expected to monitor patients every 30 minutes. During an interview on 10/10/24 at 10:20 AM, the Medical Director confirmed staff were expected to monitor patients every 30 minutes according to the facility’s policy.”