Mary Imogene Bassett Hospital

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 33426 Based on document review and staff interview, the facility failed to ensure policy included thresholds to be used when evaluating conductivity and pH readings. On 5/28/24 a policy was requested pertaining to use of the independent pH and conductivity meters prior to patient treatment. This request was made via email to Vice President Quality, Safety Patient Experience. The policy received in response to this request did not include procedures for comparing the independent conductivity meter reading to the dialysis machine reading or expected thresholds for pH or conductivity. AAMI RD 52: 2004 Table 4 specifies that for dialysate conductivity and pH testing, the conductivity should be verified as being within +/-0.5 of the nominal machine value, and the pH should be within the range of 6.9-7.6.”

“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: 33426 Based on document review and staff interview, the facility failed to ensure all equipment is maintained and operated in accordance with the manufacturer’s recommendations and facility policy. On 5/22/24 review was conducted of documentation of the logs for calibration of the pH and conductivity meters used on the treatment floor, titled “Documentation Sheet for Calibration and Maintenance of Phoenix Meter XL”. During this review it was noted that in several instances the readings deviated greater than 0.1 from the standard, and in these instances the meters were not recalibrated per the logs. The months of March and April of 2024 were reviewed for meter #1 and #2. Out of 104 total readings within this sample there were 27 instances of the conductivity reading being between 13.6 and 13.8 and not having been recalibrated. In that same sample there were 3 instances of the pH reading being 6.8 and not having been recalibrated. Instructions on these forms indicate that for any reading greater than 0.1 from the standards the Phoenix Meter XL must be recalibrated. The standard is 14.0 for conductivity and 7.0 for pH. Review of the Standard Operating Procedure titled “Phoenix Meter XL” confirmed this policy. The policy is also in accordance with manufacturer specifications. This finding was confirmed through interview with Vice President Quality, Safety Patient Experience on 5/22/24 at 4:00 PM. Staff reeducation began being implemented by the facility during the survey.”

“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: 09785 Based on document review the facility failed to ensure the quality assessment and performance improvement (QAPI) program included review of issues associated with pH and conductivity meter calibrations. On 5/22/24 review was conducted of documentation of the logs for calibration of the pH and conductivity meters used on the treatment floor, titled “Documentation Sheet for Calibration and Maintenance of Phoenix Meter XL”. It was identified during pH/conductivity meter log reviews that meters were not being calibrated when results fell outside the limits indicating need for calibration. The facility’s QAPI documentation was also reviewed on 5/22/2024. QAPI documentation did not include identification or review of these issues with pH/conductivity meter logs. QAPI review and analysis must include measures of water and dialysate quality and safety, and safe machine maintenance.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 09785 Based on staff interview and facility record review, the facility’s Quality Assurance/Performance Improvement (QAPI) process collected, but failed to analyze patients’ vaccination status as a quality indictor for the unit’s infection control program. Findings are: -The facility’s QAPI documentation was reviewed on 5/22/2024. Vaccination status of patients was collected in the patient assessment process, but aggregate data was not accurately summarized and analyzed so that opportunities for improvement could be identified and implemented. Findings: -Hepatitis B status of all patients was reviewed by the State Agency (SA) for October 2023 to March 2024. The QAPI documents contained supporting documentation listing the hepatitis B status of all patients. Patients were also reported on a separate summary sheet, the “QAPI tool” as being in one of four categories: hepatitis B antibody positive, hepatitis B non-responder, “in series” and “refusals” But the number reported on the “QAPI tool” did not account for the entire census of the facility. -For October 2023 the facility census was 36; the QAPI tool reported 14 patients across the categories. -For November 2023 the facility census was 40; the QAPI tool reported 13 patients across the categories. -For December 2023 the facility census was 39; the QAPI tool reported 14 patients across the categories. -For January 2024 the facility census was 38; the QAPI tool reported 11 patients across the categories. -For February 2024 the facility census was 39; the QAPI tool reported 11 patients across the categories. -For March 2024 the facility census was 40; the QAPI tool reported 11 patients across the categories. -The facility will need to ensure that all patients on census are reported in the correct category so that opportunities for improvement, if any, can be identified. -This finding was verified with the Interim Nurse Manager during an interview from 2:00 to 2:30 PM on 5/22/2024.”