Davita Cedar Rapids 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: 36083 Based on records review, observations, and interview, the facility failed to ensure consistent hand hygiene practices before and after use of gloves for 2 of 5 staff members (Staff A and Staff D) observed during patients’ care and treatment. The facility reported a census of 44 in-center dialysis patients at the time of the survey. Findings include: 1. The Policy # 1-05-01, titled, Infection Control for Dialysis Facilities, with latest revision date of April 2023, notes its purpose to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. The policy directs staff members to perform hand hygiene prior to gloving and immediately after removal of gloves. 2. Observations on 8/6/24, showed the following: - At 2:04 PM, Staff D showed Patient #10’s prescription in the computer (touching the keyboard and screen). Without hand hygiene, Staff D donned gloves to touch the hose from the dialysis machine (moving it from the outlet labeled 2 K 2.5 Ca to the 3 K 2.5 outlet), thereafter, Staff D removed gloves but did not perform hand hygiene and resumed showing Patient #10’s prescription on the computer. Staff D then donned another pair of gloves, without performing hand hygiene, and touched the dialysis machine to show the settings for prescription verification. Staff D removed gloves and did not do hand hygiene. -At 2:10 PM, Staff D logged into the computer at Station #5 to show Patient #16’s prescription. Staff D donned gloves without hand hygiene first and touched Patient #16’s dialysis machine to show settings. Thereafter, Staff D removed gloves but did not perform hand hygiene. 3. Observations on 8/7/24, showed the following: -At 9:08 AM, Staff D walked to Station #7, donned gloves without first performing hand hygiene, and assessed Patient #13 after treatment. Staff D removed gloves, did not perform hand hygiene, and then went to clean a used stethoscope with an alcohol pad. -At 9:26 AM, Staff D was setting up the machine in the isolation room (used as regular station) wearing gloves, thereafter, Staff D removed gloves but did not perform hand hygiene, and stepped out from the room. -At 10:02 AM, Staff D went to Station #7, donned gloves without first performing hand hygiene, and did the pre-treatment assessment for Patient #14. Thereafter, Staff D removed gloves, did not do hand hygiene, and went to clean stethoscope with a small alcohol pad. -At 10:06 AM, Staff D went to Station #5, donned gloves without first performing hand hygiene. Staff D assessed Patient #5 prior to treatment. Staff D removed gloves and did not perform hand hygiene. 4. On 8/8/24 at 11:40 AM, the Clinical Services Manager (CSM) acknowledged the importance of hand hygiene before and after use of gloves during patient care and procedures involving touching dirty surfaces. The CSM indicated expectation for staff to follow best practice guidelines and facility policy. 50072”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 50072 Based on observations, interview, and review of facility policy, it was determined the facility failed to ensure staff performed infection control practices to minimize the spread of infections or bloodborne pathogens in the dialysis facility in accordance with the facility’s policy. The facility staff reported a census 63 patients at the time of survey; 44 in-center hemodialysis patients and 19 home therapy services patients, who could potentially be adversely affected by the deficient practice. Findings include: 1. Review of the facility policy: 01-05-01, titled INFECTION CONTROL FOR DIALYSIS FACILITIES, with the latest revision date of April 2023, reads in part, “ ...12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area ...” 2. Observations on 08/07/24 at 1:30 pm in the storage area located adjacent to the treatment area included an IV pump with a dried red substance resembling blood splattered and smeared on the left side of the pump. Also noted inside the storage area to the right side, near a mini refrigerator, the wall and area around the wall charger contained a thick dark brown colored splatter. 3. During an interview with the Facility Administrator (FA) on 08/07/24 at 1:42 pm, they observed the IV pump contained in the storage area located off the treatment floor. The FA indicated the expectation is that equipment in storage should be cleaned before and after patient use. 4. During an interview with the Medical Director on 08/08/24 at 8:56 am, they acknowledged the storage area seemed a bit cluttered and identified any unknown substance on equipment or walls could be “a source for infection.””

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 50072 Based on documents review, policy review, and staff interviews, the facility did not ensure quality of dialysis water by its failure to ensure water processes or components were within the acceptable limits. The facility staff reported a census 63 patients at the time of survey; 44 in-center hemodialysis patients and 19 home dialysis therapy patients, who could potentially be adversely affected by the deficient practice. Findings include: 1. Review of Policy: 1/17/02, titled DAILY WATER TREATMENT SYSTEM MONITORING, last revised April 2023, reads in part, “ ...1. All observations and test results must be recorded on the approved Daily Water Treatment Log and required IT Clinical System entries ... 5. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log ... 7. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated ...” 2. Review of facility documents titled “CWP (Central Water Processing) Daily Water Log,” dated 06/01/24 - 07/31/24, showed: a. Line 25 “Ultrafilter Delta Pressure (Pre - Post) entry shows the entry documented outside of Acceptable Limits. A handwritten note date “07/03” at the bottom of the log indicates Biomedical Technician (Biomed) was notified. Line 27 “If Required, Time when Biomed Contacted for Direction or Assistance.” The entry for line 27 on this date read “NA.” b.On 07/05/24 there was no entry entered in line 17 “Loop Return Flow Rate, L/min” . Despite no entry on line 17, line 29 “Initials of Licensed Nurse (Verifying that Log is Complete and Results are within Acceptable Limits)” was signed off. c. On 07/06/24, lines 30 “End of Day Hardness Test Result,” Line 31 “At end of day, have you placed the CM 130 in idle mode? (Y/N)” and Line 32 “Time and initials of Teammate performing End of Day Hardness test” were left blank. d. On 07/08/24, Line 14 value entered was 10.5, outside of “Acceptable Limits” according to the log. Line 29 “Initials of Licensed Nurse (Verifying that Log is Complete and Results were within Acceptable Limits)” was signed off with no indication Biomed was notified. 3. On 08/07/24 at 9:20 am, the Facility Administrator verified the information included in the CWP Daily Water Logs. They confirmed they review the water logs for completion and have scheduled an in-service with staff to review expectations for completing the CWP Water Logs. 4. On 08/07/24 at 10:11 am, the Clinical Services Manager verified the missing entries in the CWP Daily Water Logs. They indicated the log should include written documentation at the bottom or on the back of the log regarding any entries outside of the acceptable limits. The Clinical Services Manager noted that staff need to clearly document communication with Biomed and when they’ve been given clearance to proceed with treatments. 5. On 08/07/24 at 2:15 pm, the Biomedical Operations Director verified the missing entries contained in the CWP Daily Water Logs. They acknowledged the entry on 07/08/24, line 14, is outside of acceptable limits according to the parameters listed. They further verified the level wasn’t caught until the following day when it was reported to the Biomedical team for direction. The Biomedical Operations Director indicated, “That’s a miss,” noting the Biomedical team should have been made aware of the out of range reading on 07/08/24 when the value was first recorded.”

“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: 36083 Based on documents review, observations, and interviews, the facility did not ensure correct dialysis prescription for 1 of 4 patients (Patient #10) observed for prescription verification. The facility reported a census of 44 in-center hemodialysis patients at the time of the survey. Findings include: 1. The Policy # 1-03-08, titled, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, dated April 2024, indicates that staff verify patient identity and prescriptions prior to the initiation of treatment. The policy provides that prescription components are confirmed by a licensed nurse within one hour of treatment initiation, to include verifying correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings. 2. The first step of Procedure # 1-03-081, titled, Treatment Initiation Utilizing B Braun Dialog+ Dialysis Delivery Systems with All Single Use Dialyzer Types and Streamline Blood Lines, dated October 2021, directs staff to verify that the correct dialysate concentrate is attached. The procedure also indicates treatment checks should be completed every 30 minutes. 3. During observations on 8/6/24 at 2:04 PM, showed Patient #10 on dialysis treatment at Station #8, with 49 minutes left of treatment time. Patient #10’s dialysis machine was hooked to the outlet that delivered 2 K (potassium) and 2.5 Ca (calcium). Staff D disconnected the hose/line from Patient #10’s machine and immediately moved and connected it to the outlet for 3 K and 2.5 Ca. A review of Patient #10’s prescription revealed Patient #10’s dialysate concentrate as 3 K and 2.5 Ca and 3.5 hours treatment time. Staff D acknowledged that Patient #10 had been on treatment with the wrong dialysate for 2 hours and 45 minutes, indicating failure to verify correct prescription during treatment initiation and monitoring. 4. During interview on 8/8/24 at 11:40 AM, the Facility Administrator (FA) and the Clinical Services Manager (CSM) also verified that Patient #10 received incorrect dialysate concentrate and showed that the incident was reported in the facility’s incident reporting system. The FA and CSM indicated expectations for staff to ensure patients dialyzed with the correct prescriptions.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 36083 Based on documents review, observation, and interviews, the facility did not ensure medical records/documentation reflected patients’ failure to receive the prescribed treatments for 1 of 4 patients observed for prescription verification (Patient #10) and for 1 of 2 patients reviewed for adverse occurrence report (Patient #6). The facility reported a census of 44 in-center hemodialysis patients at the time of the survey. Findings include: 1. The Policy # 1-03-08, titled, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, dated April 2024, indicates that staff verify patient identity and prescriptions prior to the initiation of treatment. The policy provides that prescription components are confirmed by a licensed nurse within one hour of treatment initiation, to include verifying correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings. The policy also provides if the dialysis prescription is not being met, the reason will be documented; and all findings, interventions, and patient response will be documented in the patient’s medical record. The policy further provides that abnormal findings should be reported to the licensed nurse and documented in the patient’s medical record. 2. The Patient Summary Report dated 7/19/24, showed Patient #10’s dialysis prescription, including dialysate bath of 3 K (potassium) and 2.5 Ca (Calcium). 3. During observation on 8/6/24 at 2:04 PM, Patient #10 dialyzed for 2 hours and 45 minutes with 2 K and 2.5 Ca. Staff D who was present during the observation, indicated Patient #10 should have been on 3 K and 2.5 Ca. Staff D verified Patient #10 did not receive the prescribed dialysate. 4. The Treatment Details Report dated 8/6/24, also indicated Patient #10’s dialysis prescription to include dialysate composed of 3 K and 2.5 Ca. However, the report lacked entries to show Patient #10 dialyzed on 2 K and 2.5 Ca dialysate for 2 hours and 45 minutes during this particular treatment. 5. On 8/8/24 at 11:40 AM, the Clinical Services Manager (CSM), stated that Patient #10’s medical records lacked entries to show dialysis treatment error on 8/6/24 regarding the wrong dialysate. The CSM indicated expectations that errors such as treatments with wrong prescription should be documented in the patient’s medical records. 44475”