Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification survey completed on March 24, 2023, Fresenius Medical Care Three Rivers 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 on March 24, 2023, Fresenius Medical Care Three Rivers 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)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on review of facility policy, medical records (MR) and interview with facility staff, the facility failed to assess/manage patient's blood pressure and/or heart rate needs for one (1) of six (6) in center hemodialysis patient medical records reviewed (MR2).
Findings Included:
Review of facility policy on 3/24/23 revealed: "Nursing Supervision and Delegation...Reporting of patient care findings to the team nurse in charge...staff member who collects information pre, post, and during treatment will document their findings...abnormal findings in the patient's condition...must be reported to the qualified licensed registered nurse...Document all findings in the patient's medical record...The following criteria can be used as a guideline to identify when a PCT (patient care technician)...or RN (registered Nurse) shall refer a patient to the Team Leader/Charge Nurse for further assessment pre, during, post treatment...Blood Pressure...A Systolic pressure greater than 180 mm/Hg (milliliters/mercury) and/or diastolic pressure greater than 100 mm/HG at any time before, during, or after the treatment...Cardiac...A pulse greater than 100 or less than 60 beats per minute... "
Review of MR2 on 3/23/23 at approximately 1:30 PM: Admission 12/5/22. Physician order Scheduled hours (treatment time) 4:15 (hours/minutes) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3/6/23 to 3/20/23 revealed:
3/6/23, Pre Dialysis, BP (blood pressure) Sit 125/107, BP Stand 160/103; Intradialytic, 5:52 AM BP 157/108, Pulse 112, 6:03 AM Pulse 117, 6:30 AM Pulse 119, 9:34 AM Pulse 108.
3/10/23, Pre Dialysis, BP (blood pressure) Sit 178/112, BP Stand 196/119, Pulse 110; Intradialytic, 5:32 AM BP 164/117, Pulse 116, 6:00 AM Pulse 119, 6:33 AM Pulse 113, 7:14 AM Pulse 104, 8:05 AM Pulse 112, 8:37 Pulse 105.
3/13/23, Pre Dialysis, BP (blood pressure) Sit 183/112, Pulse 118; Intradialytic, 5:49 AM BP 175/118, Pulse 120, 7:09 AM Pulse 115, 7:36 AM Pulse 110, 8:09 AM BP Pulse 106, 9:04 AM Pulse 119, 9:40 AM BP 155/106, Pulse 109, 9:52 AM BP 131/108; Post Dialysis BP 131/106.
3/17/23, Intradialytic, 6:36 AM Pulse 121, 7:10 AM Pulse 106, 7:34 AM Pulse 108, 8:09 AM Pulse 115, 8:34 AM Pulse 103, 9:34 AM Pulse 113.
There was no documented evidence of interventions/assessments provided for patient pulse greater than 100 beats per minute and/or patient systolic BP greater than 180/diastolic BP greater than 100 in accordance with facility policy for treatment dates reviewed.
Exit conference conducted on 3/24/23 at approximately 1:30 PM with Administrator (EMP1) and Clinical manager (EMP2). Above findings were reviewed.
Plan of Correction:To ensure compliance the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on policy:
- Nursing Supervision and Delegation
Emphasis will be placed on ensuring that any vital signs, including pulse and blood pressure (BP) not within the parameters of the policy are reported to the registered nurse (RN). The meeting will reinforce the importance of the staff documentation of the RN notification on the treatment sheet. Upon notification, the RN will then complete an assessment and intervention if indicated. The meeting will review that the RN must document the findings of the assessment, outcome of the intervention and the physician notification.
Inservicing will be completed by April 7, 2023. All training documentation will be on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time, if improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed monthly following the Quality Assessment and Performance Improvement (QAPI) program. A plan of correction (POC) specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion date: May 5, 2023
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
Observations:
Based on a review of facility policy, medical records (MR) and interviews with staff, the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician for six (6) of six (6) incenter patient medical records reviewed. (MR1 - MR6).
Findings Included:
Review of facility policy on 3/24/23 revealed: "Patient Assessment and Monitoring...Monitoring During Treatment...Step 3...Check machine settings and measurements...Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate...Check dialysate flow rate setting is correct, and prescribed flow is being delivered..."
Review of MR1 on 3/23/23 at approximately 12:30 PM: Admission 1/5/23. Physician order for BFR (blood flow rate) 350 ml/min (milliliters/minute), DFR (dialysate flow rate) 500 ml/min, Scheduled hours (treatment time) 4:00 (hours) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3//23 to 3/20/23 revealed:
3/7/23, BFR at 400 ml/min, DFR at 800 ml/min throughout treatment.
3/11/23, BFR at 400 ml/min, DFR at 800 ml/min throughout treatment.
3/16/23, BFR at 400 ml/min, DFR at 800 ml/min throughout treatment.
3/18/23, DFR at 800 ml/min throughout treatment.
3/21/23, BFR at 400 ml/min, DFR at 800 ml/min throughout treatment.
MR1 treatment flowsheets reviewed above did not document reason BFR's/DFR's were not at prescribed rates.
Review of MR2 on 3/23/23 at approximately 1:30 PM: Admission 12/5/22. Physician order for BFR (blood flow rate) 400 ml/min (milliliters/minute), DFR (dialysate flow rate) 800 ml/min, Scheduled hours (treatment time) 4:15 (hours/minutes) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3/6/23 to 3/20/23 revealed:
3/8/23, BFR at 250 ml/min throughout treatment.
3/13/23, BFR at 200 ml/min throughout treatment.
3/15/23, BFR at 250 ml/min throughout treatment.
3/17/23, BFR at 250 ml/min throughout treatment.
3/20/23, BFR at 250 ml/min throughout treatment.
MR2 treatment flowsheets reviewed above did not document reason BFR's were not at prescribed rates.
Review of MR3 on 3/24/23 at approximately 9:30 AM: Admission 12/4/20. Physician order for BFR (blood flow rate) 400 ml/min (milliliters/minute), DFR (dialysate flow rate) Autoflow 2.0 (2 times the BFR = 800), Scheduled hours (treatment time) 4:00 (hours) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3/6/23 to 3/20/23 revealed:
3/8/23, BFR at 450 ml/min throughout treatment.
3/17/23, BFR at 450 ml/min throughout treatment.
MR3 treatment flowsheets reviewed above did not document reason BFR's were not at prescribed rates.
Review of MR4 on 3/24/23 at approximately 10:35 AM: Admission 12/5/22. Physician order for BFR (blood flow rate) 450 ml/min (milliliters/minute), DFR (dialysate flow rate) 800 ml/min, Scheduled hours (treatment time) 4:00 (hours) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3/6/23 to 3/20/23 revealed:
3/8/23, BFR at 400 ml/min throughout treatment.
3/10/23, BFR at 400 ml/min throughout treatment.
3/15/23, BFR at 400 ml/min throughout treatment.
MR4 treatment flowsheets reviewed above did not document reason BFR's were not at prescribed rates.
Review of MR5 on 3/24/23 at approximately 11:20 AM: Admission 1/23/23. Physician order for BFR (blood flow rate) 400 ml/min (milliliters/minute), DFR (dialysate flow rate) 800 ml/min, Scheduled hours (treatment time) 4:15 (hours/minutes) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3/8/23 to 3/20/23 revealed:
3/8/23, BFR at 350 ml/min throughout treatment.
3/15/23, BFR at 450 ml/min throughout treatment.
3/15/23, BFR at 450 ml/min throughout treatment.
MR5 treatment flowsheets reviewed above did not document reason BFR's were not at prescribed rates.
Review of MR6 on 3/24/23 at approximately 12:10 PM: Admission 9/22/17. Physician order for BFR (blood flow rate) 400 ml/min (milliliters/minute), DFR (dialysate flow rate) 500 ml/min, Scheduled hours (treatment time) 3:45 (hours/minutes) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 3/10/23 to 3/20/23 revealed:
3/13/23, BFR at 350 ml/min throughout treatment.
3/15/23, BFR at 370 ml/min, DFR at 800 ml/min throughout treatment.
MR6 treatment flowsheets reviewed above did not document reason BFR's/DFR were not at prescribed rates.
Exit conference conducted on 3/24/23 at approximately 1:30 PM with Administrator (EMP1) and Clinical manager (EMP2). Above findings were reviewed.
Plan of Correction:To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Patient Assessment and Monitoring
Emphasis will be placed on ensuring that any machine parameters not within the prescribed limits must be reported to the RN for evaluation, intervention and if not able to be resolved, physician notification. These parameters include the blood flow rate (BFR) and the dialysate flow rate (DFR). The reason the BFR and/or the DFR are not being achieved must be documented as well as any steps taken to correct the issue. The staff will be instructed that there must be documentation of the RN notification by the patient care technician (PCT).
Inservicing will be completed by April 7, 2023. All training documentation will be on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time, if improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAPI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion date: May 5, 2023
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