Davita Mayland Dialysis Center

“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: 35306 Based on policy review, observation, and interview, patient care staff failed to prevent cross contamination by failing to remind patients to perform hand hygiene in 2 of 2 observations of patients leaving the treatment area after dialysis (PCT #1, Patient #C1, CCHT #1, Patient #B3). Findings included: Review on 11/29/2023 of facility policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” (Policy: 1-05-01, revised April, 2023), revealed “...Patients and caregivers will be encouraged to...b. Perform hand hygiene after treatment before leaving the treatment area...” 1. Observation on 11/29/2023 at 1004 revealed PCT #1 accompanied Patient #C1 to the scale via wheelchair, weighed the patient and after removing PPE, the PCT wheeled the patient to the lobby. Observation revealed the PCT failed to remind the patient to perform hand hygiene prior to leaving the treatment area. Interview on 11/29/2023 at 1015 with PCT #1 revealed “We are supposed to remind them and I forgot.” Interview on 11/29/2023 at 1715 with the FA and MCS, revealed “They [patients] are educated on that [hand hygiene] often and should be washing their hands when they leave.” The interview revealed staff “should be encouraging patients to wash their hands when they leave.” 2. Observation on 11/29/2023 at 1030 revealed CCHT #1 accompanied Patient #B3 to the scale via a rolling walker. The patient weighed himself, told CCHT #1 his weight for documentation, removed a glove from the hand used to hold pressure to the access site post-removal of the hemodialysis needles, laid it on a shelf beside the scales, and walked to the lobby while CCHT #1 documented the patient’s weight. Observation revealed the CCHT failed to remind the patient to perform hand hygiene prior to leaving the treatment area. Interview on 11/29/2023 at 1040 with CCHT #1 revealed “Usually I remind them but I was distracted I guess, with trying to get the weight documented. It just slipped my mind.” Interview on 11/29/2023 at 1715 with the FA and MCS, revealed “They [patients] are educated on that [hand hygiene] often and should be washing their hands when they leave.” The interview revealed staff “should be encouraging them [patients] to wash their hands when they leave.””

“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: 35306 Based on policy review, observation and staff interview, the facility staff failed to prevent possible cross-contamination in 2 of 2 observations of patient care staff cleaning and disinfecting dialysis stations (Sta. C9, PCT #1 and Sta. B7, CCHT #1). Findings included: Review on 11/30/2023 of facility policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” (Policy: 1-05-01, revised April, 2023), revealed “... The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients... DISINFECTION...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings....and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touch screens; countertops)...” 1. Observation on 11/29/2023 at 1007, revealed PCT #1 cleaned and disinfected dialysis station #C9. Observation revealed the back HDM was not included in the cleaning and disinfection process. Interview on 11/29/2023 at 1030 with PCT #1, revealed she did not include the back of the HDM in the disinfection process. Interview revealed, “We are supposed to wipe the back of the machines and I forgot.” Interview on 11/29/2023 at 1715 with the FA and MCS, revealed “They [facility staff] are suppose to wipe the backs of the HDM, in addition to the wall box, drain and water supply lines.” 2. Observation on 11/29/2023 at 1030, revealed CCHT #1 cleaned and disinfected dialysis station #B7. Observation revealed the back dialysis machine was not included in the cleaning and disinfection process. Interview on 11/29/2023 at 1055 with CCHT #1, revealed she did not include the back of the HDM in the disinfection process. Interview revealed, “We’re suppose to [disinfect the back of the HDM] and I forgot to do it.” Interview on 11/29/2023 at 1715 with the FA and MCS, revealed “They [facility staff] are suppose to wipe the backs of the HDM, in addition to the wall box, drain and water supply lines.””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 35306 Based on policy review, “Annual Competency Certification Course List” review, personnel file worksheet review, internal Improvement Plan review, and staff interview, the facility staff failed to ensure 4 of 4 direct care personnel (FA, RN #1, CCHT #1, and CCHT #2) completed annual water and dialysate competency training. Findings included: Review on 11/30/2023 of policy, “TEAMMATE QUALIFICATIONS, LICENSURE AND ADEQUATE TEAMMATE STAFFING” (Policy: 8-02-01, revised October 2017), revealed “...3. The dialysis facility’s teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s teammates (or contractors) will have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions... 17. Water Treatment System Technicians Standards: Any teammate who performs monitoring and testing of the water treatment system will complete a training program that has been approved by the medical director and the governing body. Review on 11/30/2023 of the “Annual Competency Certification Course List” (Updated 1/31/2023), revealed, “... CLED9001: ICHD RN Competency Certification... CLED9001A: ICHD RN Competency Exam & Attestation (Complete Per State Requirements) DVU2062: Annual Nurse Competency Exam CKLINV1000: Nurse Chronic Hemodialysis Skills Checklist Attestation” Review on 11/30/2023 of the “Annual Competency Certification Course List” (Updated 1/31/2023), revealed, “... CLED9002: ICHD PCT Competency Certification... CLED9002A: ICHD PCT Competency Exam & Attestation (Complete Per State Requirements) DVU2062: Annual PCT Competency Exam CKLINV1000: Patient Care Technician Chronic Hemodialysis Skills Checklist Attestation” 1. Review on 11/29/2023 of the Personnel file for the FA revealed the last documented “Water Monitoring & Testing Procedural Skills Verification Checklist” was completed on 10/17/2022. Review of FA #1’s computer-based learning transcript revealed the “Water Skills Checklist” was completed 10/17/2022. Review on 11/29/2023 of an internal Improvement Plan implemented 09/20/2023 revealed the, Improvement Plan (IP) was implemented for failure to conduct monthly “TM [teammate] file” reviews July, August, and September 2023, with am “Anticipated IP Completion” date of “11/30/2023 12:00:00AM” noted. Review revealed, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview 11/30/2023 at 1300 with the FA revealed the administrative staff were unable to locate any documentation of a water monitoring checkoff competency since 10/17/2022 for the FA. Interview revealed the AA position became vacant and personnel file audits were missed July, August, and September 2023. Interview revealed that once it was discovered on 11/29/2023, that staff had failed to complete the annual “Water Monitoring and Testing Procedural Skills Verification Checklist”, the AA updated the IP to include, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview revealed facility administrative staff learned the “Water Monitoring & Testing Procedural Skills Verification Checklist” 11/28/2023 during the personnel file review during completion personnel file worksheet review. 2. Review on 11/29/2023 of the Personnel file for RN #1 revealed the last documented “Water Monitoring & Testing Procedural Skills Verification Checklist” was completed on 10/17/2022. Review of RN #1’s computer-based learning transcript revealed the “Water Skills Checklist” was completed 10/17/2022. Review on 11/29/2023 of an internal Improvement Plan implemented 09/20/2023 revealed the, Improvement Plan (IP) was implemented for failure to conduct monthly “TM [teammate] file” reviews July, August, and September 2023, with am “Anticipated IP Completion” date of “11/30/2023 12:00:00AM” noted. Review revealed, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview 11/30/2023 at 1300 with the FA revealed the administrative staff were unable to locate any documentation of a water monitoring checkoff competency since 10/17/2022 for RN #1. Interview revealed the AA position became vacant and personnel file audits were missed July, August, and September 2023. Interview revealed that once it was discovered on 11/29/2023, that staff had failed to complete the annual “Water Monitoring and Testing Procedural Skills Verification Checklist”, the AA updated the IP to include, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview revealed facility administrative staff learned the “Water Monitoring & Testing Procedural Skills Verification Checklist” 11/28/2023 during the personnel file review during completion personnel file worksheet review. 3. Review on 11/29/2023 of the Personnel file for CCHT #1 revealed the last documented “Water Monitoring & Testing Procedural Skills Verification Checklist” was completed on 10/17/2022. Review of CCHT #1’s computer-based learning transcript revealed the “Water Skills Checklist” was completed 10/17/2022. Review on 11/29/2023 of an internal Improvement Plan implemented 09/20/2023 revealed the, Improvement Plan (IP) was implemented for failure to conduct monthly “TM [teammate] file” reviews July, August, and September 2023, with am “Anticipated IP Completion” date of “11/30/2023 12:00:00AM” noted. Review revealed, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview 11/30/2023 at 1300 with the FA revealed the administrative staff were unable to locate any documentation of a water monitoring checkoff competency since 10/17/2022 for CCHT #1. Interview revealed the AA position became vacant and personnel file audits were missed July, August, and September 2023. Interview revealed that once it was discovered on 11/29/2023, that staff had failed to complete the annual “Water Monitoring and Testing Procedural Skills Verification Checklist”, the AA updated the IP to include, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview revealed facility administrative staff learned the “Water Monitoring & Testing Procedural Skills Verification Checklist” 11/28/2023 during the personnel file review during completion personnel file worksheet review. 4. Review on 11/29/2023 of the Personnel file for CCHT #2 revealed the last documented “Water Monitoring & Testing Procedural Skills Verification Checklist” was completed on 10/17/2022. Review of CCHT #2s computer-based learning transcript revealed the “Water Skills Checklist” was completed 10/17/2022. Review on 11/29/2023 of an internal Improvement Plan implemented 09/20/2023 revealed the, Improvement Plan (IP) was implemented for failure to conduct monthly “TM [teammate] file” reviews July, August, and September 2023, with am “Anticipated IP Completion” date of “11/30/2023 12:00:00AM” noted. Review revealed, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview 11/30/2023 at 1300 with the FA revealed the administrative staff were unable to locate any documentation of a water monitoring checkoff competency since 10/17/2022 for CCHT #2. Interview revealed the AA position became vacant and personnel file audits were missed July, August, and September 2023. Interview revealed that once it was discovered on 11/29/2023, that staff had failed to complete the annual “Water Monitoring and Testing Procedural Skills Verification Checklist”, the AA updated the IP to include, “AA completed for October 2023 found Water Skills Checklist missing for teammates last completed was October 2022...” Interview revealed facility administrative staff learned the “Water Monitoring & Testing Procedural Skills Verification Checklist” 11/28/2023 during the personnel file review during completion personnel file worksheet review.”

“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: 35306 Based on policy review, observations, Risk Event Management (REM) log review, “Grievance/Investigation Document” reviews, medical record review, and staff interviews, the facility administrative staff failed to have an effective quality performance program by failing to implement an action plan to mitigate factors that contributed staff’s failure to connect a patients arterial and venous lines appropriately for a patient (Patient #A1). Findings included: Review on 11/30/2023 of facility policy, “RISK EVENT REPORTING POLICY (NON-TEAMMATE RELATED)” (Policy: 13-01-02, revised July, 2023), revealed “... A. PREPARING A RISK EVENT MANAGEMENT REPORT (EVENT REPORT) 1. An unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event. Such risk events include, but are not limited to....’near miss’ events. Additional examples are set forth in Exhibit “A” to this policy... B. HANDLING OF THE RISK EVENT MANAGEMENT (REM) REPORT BY THE ADMINISTRATOR/MANAGER OR DESIGNEE 1.. All additional information pertaining to the Risk Event will be entered in the “Event Report Follow Up” in the Risk Management (REM) Reporting System... 3. Risk Event Management (REM) Reports are to be trended and reviewed during the Facility Health Meeting (FHM). This includes “Near Miss” events. Any negative trend should result in a plan of action... EXHIBIT A EXAMPLES OF REPORTABLE RISK EVENTS...Near Miss Events...Treatment Error...” Review on 11/28/2023 of the “Monthly Facility event by location” log dated 11/28/2023, revealed event entries on 02/08/2023, 03/01/2023, and 07/28/2023 for Patient #A1 stating, “Specific Event Type Patient Complaint SE3 General Event Type Behavioral/Patient Complaints and Security.” Review revealed all three events were entered into the REM reporting system as “Behavioral/Patient Complaints and Security” events and not “Clinical Events”. Review on 11/28/2023 of the “Grievance/Invesitgation Document”, dated 02/08/2023 for Patient #A1 revealed, “... I [CCHT #3] accidentially placed the Art. [arterial] and Ven. [venous] needles opposite. When TX [treatment] was started I made sure to hook up his needles opposite (the correct way). It was verifiied by the RN that he was hooked up correctly... FA talked to patient to reassure that lines were correctly connected...” Review of the “Grievance/Investigation Document”, dated 03/01/2023 for Patient #A1 revealed, “The patient was cannulated with a 15G [guage] needle instead of the prescribed 14G needle [by CCHT #3]. It was not noticed until treatment was started. The patient was concerned that his treatment would be affected negatively, and stated that the tech [technician] need to pay more attention... Describe the Plan of Resolution: FA work with team on verifying orders of needle gauges before patient comes in for tx...” Review on 11/28/2023 of the Adverse Event description dated 07/23/2023 revealed, “Pt [Patient] was on machine for about 2 hours when he told PCT to look at his access and the color of the needles placed in the opposite places that they are usually placed. The blue needle and the blue lines [venous line] were placed at the lower portion of the access and the red needle and red lines [arterial lines] were placed at the top portion of the access...” Open medical record review on 11/28/2023 revealed, Patient #A1 was admitted to the facility on 05/16/2011 for ICHD three times per week on Mondays, Wednesdays, and Fridays for 210 minutes/treatment. Review the “Treatment Details Report” (TDR) for 07/28/2023 revealed CCHT #3 accessed/cannulated Patient #A1’s right forearm AVF and initiated hemodialysis at 1111. Review of nursing documentation revealed RN #1 verified the patient’s prescription and proper machine set-up at 1127 (16 minutes after hemodialysis initiation). At 1356, CCHT #3 noted that Patient #A1 alerted staff that the arterial and venous lines had been reversed at treatment initiation (2 hours, 45 minutes later). CCHT #1 noted that the line placements were reversed and treatment was resumed without further incident. Further review of the TDR revealed at 1425, CCHT #3 noted that the patient requested extra treatment time to make-up for time when treatment was running with reversed lines. Review revealed treatment was discontinued at 1552, with a total treatment duration of 279 minutes (1 hour, 9 minutes over prescribed treatment duration) recorded. Interview with CCHT #3 on 11/29/2023 at 1000, revealed she was assigned to Patient #A1 on 07/23/2023. CCHT #3 stated she inadvertantly reversed the arterial and venous lines upon initiation of treatment on 07/28/2023 at 1111. CCHT #3 stated the patient (Patient #A1) noticed the lines were reversed and alerted her. CCHT #3 stated another staff member (CCHT #1) corrected the line placement (reversed the lines) and treatment was resumed without issue. Interview revealed, CCHT #3 stated the patient (Patient #A1) requested to extend the treatment time to make up for effective treatment time that was lost when the arterial/venous lines had been reversed (2 hours, 45 minutes). Interview confirmed the arterial and venous lines were connected incorrectly and that treatment time was extended (1 hour, 9 minutes) on 07/28/2023. Interview with RN #1 on 11/29/23 at 1030, revealed an adverse event related to Patient #A1’s ICHD treatment on 07/28/2023 had occurred. RN #1 shared that CHHT #3 reversed the arterial and venous lines upon initiation of hemodialysis on 07/28/2023 at 1111 and that nursing is responsible for verifying a patient’s prescription for proper delivery of treatment once initiated. During the interview, RN #1 confirmed Patient #A1 notified CCHT #3, after treatment had been running for about 2 hours, that the arterial and venous lines had been reversed. RN #1 stated CCHT #1 corrected the line placement and treatment was resumed without further issues or complaints. Interview confirmed the patient requested extended treatment time to make up for lost time during the line reversal. Interview confirmed the arterial and venous lines were connected incorrectly on 07/28/2023 and that treatment time was extended (1 hours, 9 minutes) per the patient’s request. Interview with the FA and MCS on 11/30/2023 at 1015, revealed that the result of reversing the venous and arterial lines would be to not get as much blood cleaning as the patient is entitled to. The FA explained that the patient likely had some benefit from the dialysis, but the clean blood would have been mixed with dirty blood over and over again so that the cleaning would have been less efficient. Interview with the FA on 11/30/2023 at approximately 1215, revealed the event on 07/23/2023 was discussed with CCHT #3 and RN #1 but was unable to provide a date and time of the discussion. The FA shared at the time of the event review and follow up discussion with the staff involved, she did not believe an action plan was warranted because there were no trends identified at that time. The FA stated there had been no reeducation, observations, or audits performed in follow up of her investigation. Additionally, review of the “Grievance/Investigation Document” dated, 02/08/2023 and “Grievance/Investigation Document” dated 03/01/2023 with the FA revealed a noted trend in hemodialysis cannulation, initiation, and prescription verification errors involving CCHT #3 and RN #1. Interview confirmed the FA failed to implement an action plan to mitigate factors that contributed staff’s failure to connect a patients arterial and venous lines appropriately for Patient #A1 on 07/23/2023. NC00205427”