Kaiser Central Interstate Peritoneal Dialysis Facility

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37237 Based on observation, interview and review of documentation, it was determined that the facility failed to ensure that medications were prepared and stored correctly. Findings: Observation of the facility on 10/30/2024 beginning at 0950 revealed: - An opened MDV of “Procrit Epoetin Alfa 1mL (used to stimulate the production of red blood cells).” The BUD label covered the name of the medication, the medication strength and medication’s expiration date. - An opened MDV of “Tuberculin Purified Protein Derivative (Mantoux)” (used for TB testing). The BUD label covered the medication strength and the medication’s expiration date. Review of the facility policy, “Medication Preparation, Administration and Documentation,” dated as “Last Review 04/05/2022” stipulated “Five (5) Rights of Medication Administration ... Right medication.” The right medication could not be verified with the name and strength covered. During the observations, the Clinic Manager and the Clinic Manager in training confirmed the findings.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 37237 Based on observation and interview it was determined the facility failed to maintain a safe and functional treatment environment. Findings: Observation of the facility on 10/30/2024 beginning at 0950 revealed: - An opened container of glucose test strips that expired on 07/11/2024. A discard date of 11/01/2024 was handwritten below the expiration date. * Review of the document, “Nova StatStrip Xpress ... Glucometer,” dated as “Approval Date: 05/18/2022” stipulated in the “Equipment and Materials” section that “Once opened the test strips are stable at room temperature for up to 180 days or until the expiration date, whichever is first.” * Review of “Nova Xpress Glucometer QC Log, POCT” log sheet for glucometer tests done on 08/01/2024, 09/05/2024 and 10/01/2024 revealed the noted “Strip Lot#” matched the lot number on the expired test strip container. The “Expiration” date on the log sheet was noted as “11/1/2024.” It could not be determined if the “Expiration” on the log sheet was meant to be the expiration of the test strips or of the discard date. - An opened gallon container of “Clorox Bleach Germicidal Cleaner” in the biohazard room expired on 05/10/2024. The remaining 3 unopened containers stored in the room also expired 05/10/2024. - The treatment chairs in treatment rooms 2 and 4 failed to be thoroughly cleaned inside and out. When the sides of the treatment chairs in both training rooms were opened, a white precipitate was noted on the inside of the chairs. - The upper cabinet in treatment room 5 had about an inch long crack in the outside laminate that could not be effectively cleaned for infection control purposes. The FA and FA-in-training confirmed the above findings on 10/30/2024 during the observations.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 37237 Based on interview, review of patient records, and review of documentation, it was determined the facility failed to ensure complete self-monitoring data was received by self-care/home dialysis patients for 4 of 6 home dialysis patients (Patient #s 1, 2, 4 and 6). Findings: Patient #1 Review of patient #1’s medical records revealed patient was prescribed “Epoetin Inj 10,000 Units ... Start Date 6/17/2024 ... End Date 6/17/2025 ... ‘Inject in clinic 10,000 units (0.5 mL) subcutaneously 1 time every 7 days as directed per epo protocol.’” Review of the patient’s medication administration record for epoetin revealed Patient #1 received only 3 epoetin injections: - 08/26/2024, a one-time 20,000 unit epo injection was given. - 09/02/2024, a 10,000 unit dose was given. - 10/02/2024, a 10,000 unit dose was given. Review of an RN progress note signed on 10/17/2024 at 1330 reflected “On EPO: Yes, patient prescribed Procrit 10,000 units every week. Patient has administered at NTR. Compliance with EPO: fair Patient states [they] will go to NTR today to get dose administered.” Review of an RN progress note dated 10/30/2024 reflected “Discussed decreased hemoglobin and the importance of getting prescribed Procrit administered as ordered ... Patient’s last administration was completed on 08/26/2024. Patient “promised he would go get and administration on 10/17/2024.” Patient #2 Review of Patient #2’s medical records revealed PD treatments were ordered 7 days per week. Further review of the medical record revealed: * The last “CCPD Exchange Record” home log completed by the patient started on “9/30.” This was the only date listed but contained some cycler device information, such as “I-Drain, Total UF, Average Dwell and Lost Dwell” for 20 entries. None of the 20 entries contained documentation of the patient’s daily weight, vital signs (to include BP and temperature) or the “Dextrose” solution used. * Review of the “CCPD Exchange Record” home log dated 07/112024 through 08/12/2024 revealed the patient’s daily weight, vital signs (to include BP and temperature) and “Dextrose” solution used were sporadically documented. Of the 33 entries listed, the patient’s BP was missed 19 days and the patient’s weight was missed 15 days. * The facility failed to present documentation for home record logs between 08/13/2024 and 09/30/2024. Patient #4 Review of Patient #4’s medical records revealed PD treatments were ordered 7 days per week. Further review of the medical record revealed: * The last daily home treatment log, “CCPD Exchange Record” completed by the patient that documented the patient’s daily weight and vital signs (to include BP and temperature) was for the dates 11/26/2023 through 01/06/2024. No other home log documentation was presented for the patient. * Clinical notes from 08/26/2024 through 10/22/2024 did not show the lack of patient documentation and monitoring was addressed with Patient #4. * Review of the Progress Notes for Patient #4’s office visit on 10/11/2024 revealed a “Medication List at End of Visit as of 10/11/2024 5:12 PM” that listed updated epoetin alfa orders as followed: - “Epoetin Inj 2,000 Units, Subcutaneous, Every 7 days, give as directed ... Start date 07/10/2024 ... End Date 10/18/2024. - “Epoetin Inj 4,000 Units (Epogen/Procrit) ... 4,000 Units, Subcutaneous, Every 2 Weeks, Give as directed ... Start Date 10/11/2024 ... End Date 03/28/2025 ...” Review of the Progress Notes for Patient #4’s office visit on 07/10/2024 revealed a “Medication List at End of Visit as of 07/10/2024 11:39 AM” that listed updated epoetin alfa orders as followed: - “Epoetin Inj 3,000 Units (Epogen/Procrit) ..., 3,000 Units, Subcutaneous, Every 7 days, give as directed ... Start date 05/31/2024 ... End Date 09/20/2024. - “Epoetin Inj 2,000 Units (Epogen/Procrit) ... 2,000 Units, Subcutaneous, Every 2 Weeks, Give as directed ... Start Date 07/10/2024 ... End Date 10/18/2024 ...” Review of the patient’s medication administration records for epoetin revealed Patient #4 received only 3 epoetin injections: - 07/05/2024 - 3,000 Unit dose was given. - 09/27/2024 - 2,000 Unit dose was given. - 10/18/2024 - 4,000 Unit dose was given. Review of the monthly progress notes revealed: - 08/28/2024 Office visit - RN documented “Current Epogen prescription: Procrit 2,000 units every week. Patient has administered at NTR. Patient states [they] forgot and has held the Procrit.” - 09/20/2024 - Office visit, RN documented “On EPO: yes, NTR, patient prescribed Procrit 2,000 units every week. Compliance with EPO: inconsistent. Patient was to be getting Procrit 2,000 units every week but has not received it approximately 2 months.” - 09/27/2024 - Office visit. RN documented “Patient to train to administer Procrit at home at next MNV. Patient will have Procrit administered today and again next week until training can occur.” - 10/11/2024 - RN documented “Compliance with EPO: poor.” - 10/22/2024 - Office visit, RN documented “Current Epogen prescription: Procrit 4,000 units every other week at NTR. Patient to be trained to self administer at home at November MNV.” Patient #6 Review of Patient #6’s medical records revealed the patient transferred from another ESRD clinic and was admitted to the facility on 06/26/2024. - There was no log documentation presented for Patient #6’s home monitoring. * Review of the facility procedure, “Home Visit Evaluations,” dated as last revised 10/14/2024 stipulated: - “Home visits are an integral part of the PD patient’s regimen for health. Peritoneal Dialysis (PD) Registered Nurses (RN), as part of the interdisciplinary team (IDT), shall conduct home visits to assess, evaluate and assist patients in adapting to dialysis in the home environment.” - “Home Visit Evaluation workflow ... Set up an appointment with the patient/caregiver/helper for a home visit: During the training period ... Within 7 days of the patient starting their PD treatment ... Within 7 days after the patient completed initial training ... As needed (additional home visits performed to assess the patient’s home adaption, as needed): ... Episodes of peritonitis.” * Review of the facility policy, “Patient Home Record Keeping,” dated as last revised 05/2024 stipulated “Patients and/or patient authorized caregivers will be taught to maintain a daily record of home dialysis treatments and home medications ... Patient must bring Home Treatment log to each monthly clinic visit ... Home treatment log will be reviewed by the Peritoneal Dialysis Nurse and or Nephrologist during patient monthly clinic visits to identify trends or omissions ... Copies of the Home Treatment log will be kept in the patient medical record ... The treatment log is used to monitor patient weight, blood pressure, solution selection, ultrafiltration, medications and compliance with treatment regime.” The FA confirmed the above findings on 11/07/2024 at 0855.”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. This Standard is not met as evidenced by: 37237 Based on interview, review of medical records and review of policies and procedures, the facility failed to ensure 2 of 6 patients (Patient #2 and Patient #6) received monitoring of the patient’s home adaption by a facility RN. Findings: Patient #2 Review of Patient #2’s medical record revealed the patient received Vancomycin (an antibiotic) between 10/10/2024 and 10/19/202 for peritonitis. There was no documentation presented that an RN visited the patient’s home for evaluation of peritonitis during or after the time the patient completed the antibiotic treatment. Patient #6 Review of Patient #6’s medical records revealed the patient transferred from another ESRD clinic and was admitted to the facility on 06/26/2024. There was no documentation presented that an RN visited the patient’s home for an evaluation. Review of the facility procedure, “Home Visit Evaluations,” dated as last revised 10/14/2024 stipulated: - “Home visits are an integral part of the PD patient’s regimen for health. Peritoneal Dialysis (PD) Registered Nurses (RN), as part of the interdisciplinary team (IDT), shall conduct home visits to assess, evaluate and assist patients in adapting to dialysis in the home environment.” - “Home Visit Evaluation workflow ... Set up an appointment with the patient/caregiver/helper for a home visit: During the training period ... Within 7 days of the patient starting their PD treatment ... Within 7 days after the patient completed initial training ... As needed (additional home visits performed to assess the patient’s home adaption, as needed): ... Episodes of peritonitis.” The FA confirmed the above findings on 11/07/2024 at 0855.”