Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on June 14, 2024, Butler County Dialysis Center was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed June 14, 2024, Butler County Dialysis Center was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.80(a)(3) STANDARD
PA-IMMUNIZATION/MEDICATION HISTORY
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Immunization history, and medication history.
Observations:
Based on review of facility policy, clinical records (CR), and staff (EMP) interview, the facility failed to ensure the patient's medication history included the patient's medication allergies for four (4) of four (4) incenter hemodialysis clinical records with medication allergies (CR1-CR4).
Findings included:
Review of facility policy on June 14, 2024, at 10:45 a.m. showed, "Clinical Services ...POLICY: ... 6. All allergies, including allergies to medications will be documented in the patient's medical record."
Review of CR1 on June 12, 2024, at 11:50 a.m. showed a history and physical (H&P) from a March 2022 well visit. The H&P showed the patient had the following medication allergies verified on 2/23/2022: Xarelto (slows the time it takes blood to clot) with "severe" reaction, erythromycin (antibiotic) with "HIVES," and Morphine (opioid pain reliever) that makes the patient "sick." Review of CR1's most recent medication list (a medication history that is maintained and used when staff administer medications to patients; H&Ps are not referenced during patient medication administration) and incenter hemodialysis treatment sheet did not show the above medication allergies listed.
Review of CR2 on June 12, 2024, at 12:15 p.m. showed a hospital H&P from a 6/8/2024 admission. The H&P showed the patient had the following medication allergies verified on 6/8/2024: allantoin (a component found in skin creams and orajel), benzalkonium (antiseptic), carbamide peroxide (ear wax removal), red dye (food dye), and zinc chloride (mineral/electrolyte). Review of CR2's most recent medication list and incenter hemodialysis treatment sheet did not show the above medication allergies listed.
Review of CR3 on June 12, 2024, at 12:30 p.m. showed a hospital H&P from a 12/19/2023 admission. The H&P showed the patient was allergic to the COVID-19 vaccine that was verified on 12/19/2023. Review of CR3's most recent medication list and incenter hemodialysis treatment sheet did not show the above vaccine allergy listed.
Review of CR4 on June 12, 2024, at 1 p.m. showed a hospital H&P from a 11/2/2023 admission. The H&P showed the patient was allergic to aspartame (artificial sweetener) with a rash as a reaction that was verified on 11/1/2023. Review of CR4's most recent medication list and incenter hemodialysis treatment sheet did not show the above medication allergies listed.
During an interview on June 13, 2024, at 11:30 a.m., EMP1 (clinic manager) reviewed CR1-CR4 and confirmed the findings.
Plan of Correction:
V 000
The governing body and management staff of this facility takes this deficiency statement very seriously and will ensure that these citations are corrected and that they remain in compliance. The governing body met on 6/19/24 to review and approve the plan of correction and the tools that will keep approved plan in compliance. The in-services and tools are available for review in the facility.
V 506
An in-service was initiated to all Direct Patient Care (DPC) staff on 6/20/24 and the Interdisciplinary Team (IDT), by the Clinic Manager regarding the importance of complete and accurate medical records. Per policy G52 Medication Checks it states "6. Upon completion of the patient's admission and history, all allergies, including allergies to medications will be documented in the patient's medical record." Additionally, per G32 Medical Records policy "The Center Manager is the designated IRC/ARA care center Custodian of Medical Records. The Custodian of Medical Records' responsibilities include, but are not limited to: ensuring that the medical records are complete, documented accurately, maintained and preserved in a accordance with accepted professional standards and practices..." During the in-service it was stressed that all documentation in the patient medical record must be complete and accurate. This includes ensuring the allergies, as listed on the patient History and Physical are documented correctly onto the patient treatment sheet and medication list. It was additionally stressed that anytime the patient is hospitalized the discharge records, including the History and Physical, must be reviewed to ensure if there are any changes, such as to the patient allergies list, this is documented on the treatment sheet and medication list.
All patient records, including CR1, CR2, CR3 and CR4 have been reviewed to ensure the allergies from the History and Physical are accurately documented throughout the treatment sheet and medication list. To ensure compliance with accurate documentation of patient allergies the CM will review the History and Physical on all the new admission records and hospitalization records, weekly for 3 months, to ensure allergies are accurately documented in the treatment record and medication list. A CM monitoring tool has been developed to monitor this action. As the Custodian of Medical Records the CM will ensure ongoing compliance by periodically reviewing documentation to ensure it is complete and accurate.
The CM will ensure compliance through direct observation and use of the CM monitoring tool. The CM monitoring tool will be brought to the monthly Quality Assessment Performance Improvement (QAPI) meeting, of which the medical director is a member, for review and further action will be taken as deemed appropriate by the committee such as continued monitoring or disciplinary action.
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on review of National Kidney Foundation (NKF) Guidelines, observation (OBS), and staff (EMP) interview, the facility failed to ensure three (3) of three (3) patients with an arteriovenous fistula (AVF) washed their access prior to disinfection and initiation of dialysis (AVF1, AVF2, & AVF3).
Findings included:
According to NKF Guidelines, "Tips for Everyday Care of Your AV Fistula or Graft Prevent Infection ... Wash your access site before every dialysis treatment. Your dialysis center has hand washing sinks and antimicrobial soap." Retrieved from https://www.kidney.org/sites/default/files/11-50-0216_va.pdf
Observation (AVF1) on treatment floor during initiation of dialysis on June 13, 2024, at 9:45 a.m. revealed patient arrive to the unit and wash his/her hands in the sink but not his/her access (did not bother to roll up sleeves of long-sleeve shirt). Patient walked to station 4 and sat down. The registered nurse wiped patient's access with alcohol prep wipes, inserted needles, and initiated dialysis.
Observation (AVF2) on treatment floor during initiation of dialysis on June 13, 2024, at 10:10 a.m. revealed patient arrive to the unit and wash his/her hands in the sink but not his/her access. Patient walked to station 20 and sat down. The patient care technician wiped patient's access with alcohol prep wipes, inserted needles, and initiated dialysis.
Interview with EMP10 (registered nurse who performed pre-treatment assessments near facility's handwashing sink) on June 13, 2024, at 9:35 a.m. confirmed the patient's from AVF1 and AVF2 only washed their hands in the sink and not their access.
Observation (AVF3) on treatment floor during initiation of dialysis on June 14, 2024, at 9:25 a.m. revealed patient arrive to the unit and wash his/her hands in the sink but not his/her access. Patient walked to the dialysis station and sat down. Interview with EMP11 (registered nurse who performed pre-treatment assessments near facility's handwashing sink) on June 14, 2024, at 9:27 a.m. confirmed the patient only washed their hands in the sink and not their access. Surveyor requested that EMP11 not mention this finding until surveyor finished the AVF3 observation. On June 14, 2024, at approximately 9:35 a.m., EMP4 (registered nurse) walked to the station and whispered to the patient care technician (PCT) who would be initiating the patient's dialysis that he/she needed to wash the patient's access. At this time, the PCT left the station and retrieved a prepackaged hand sanitizing wipe to use on the patient's access. The observation was terminated and interview with EMP4 at 9:40 a.m. confirmed that he/she prompted the PCT to "wash" the patient's access.
Plan of Correction:V 550
An in-service was initiated to all Direct Patient Care (DPC) staff, including EMP 10, EMP 4 on 6/20/24 by the Clinic Manager (CM) regarding ensuring patients wash their access prior to cannulation. Per policy IC04A AVF-AVG Cannulation, Treatment Initiation and Termination policy it states "1. The access will be washed with antibacterial soap and water or skin antiseptic wipe, prior to preparing the site for cannulation." Also, per National Kidney Foundation Access Care it states "Tips for everyday care of your AV fistula or graft – Wash your access site every day. Ask your dialysis care team to recommend a good soap to use. Wash your access site before every dialysis treatment." It was stressed during the in-service that to prevent the potential for vascular related infections the patients should wash their accesses with soap and water prior to cannulation. Prior to the DPC staff member initiating dialysis, they should ask the patient if they have washed their access and educate the patient as to why it should be done prior to cannulation. This education is to be documented in the patient's medical record. If the patient refuses to wash their access this should be documented in the patient's medical record. Also, if for any reason the patient is unable to wash their access, then the staff should assist the patient with washing their access prior to cannulation. All patients, including AVF1, AVF2, and AVF3 will be educated by 7/22/2024 on the requirement for washing their vascular access with soap and water prior to cannulation. Each DPC staff member will educate their patients, including patients AVF1, AVF2, and AVF3, on the requirement for washing their access with soap and water, each treatment for 4 weeks, and observe or assist the patient with washing their hands and dialysis access with soap and water. If patient refuses to wash their access, this will be documented on the patient flow sheet and the CM will meet with the patient to provide further education to the patient. To ensure further compliance, the Clinic Manager will spot check the treatment floor, one day a week for 12 weeks, prior to and during patient initiation, to ensure staff are prompting patients to wash their access with soap and water prior to cannulation or assisting them to wash their access prior to cannulation if they are not able to. A CM monitoring tool was developed to monitor this action. Additionally, to ensure ongoing compliance, staff are to document a Yes or No in the EMR Treatment flow sheet indicating if the patient has washed their access prior to cannulation. The CM as the custodian of medical records will periodically review this documentation on the treatment flowsheet to ensure it is being conducted and will meet with staff and patients who are not in compliance. The Clinic Manager will ensure compliance through direct observation and use of the CM monitoring tool. All findings from the CM monitoring tool will be addressed at the monthly QAPI meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly audits or if trends are identified, disciplinary action.
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