Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on August 31, 2023, Fresenius Medical Care-Greensburg, 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 August 31, 2023, Fresenius Medical Care-Greensburg, was identified 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:
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on reviews of medical records (MR), facility policy, and staff (EMP) interview, the facility failed to provide the necessary care and services to manage the patient's volume status for five (5) of five (5) in center dialysis records reviewed. (MR1-5)
Findings included:
Review of facility policy on August 29, 2023, at approximately 1:30pm revealed:
"Patient Assessment and Monitoring...Pre-Treatment. Pulse Record Pulse. Verify pulses manually if automated reading display below 60 or greater than 100 beats per minute. Document irregular rhythms...During Treatment...Pulse Record Pulse. Verify pulses manually if automated reading display below 60 or greater than 100 beats per minute. Document irregular rhythms. Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular...""
"Patient Monitoring and safety Checks During Hemodialysis and Treatment...Policy...Patient Monitoring, Monitor and document every 30 minutes or more frequently as need but not to exceed 45 minutes or per state regulations in the FKC Treatment Record..."
Review of MR on 8/31/2023 at between approximately 9:30am and 2:00pm revealed:
MR1, admission date 7/31/2023, treatment dates reviewed 8/4/23-8/5/23.
8/21/23 at 3:31pm pulse documented to be 48. No documentation of manual recheck or report to nurse per policy.
MR2, admission date 6/1/2023, treatment dates reviewed 7/24/23-8/11/23.
7/24/23 at 2:03pm at 3:43pm pulse documented to be 56. No documentation of manual recheck or report to nurse per policy. One hour and 31 minutes between documented vitals and safety check (1:31pm-3:02pm)
8/5/23 58 minutes between documented vitals and safety checks (8:03am-9:01am)
8/7/23 at 3:43pm pulse documented to be 103. No documentation of manual recheck or report to nurse per policy. One hour and 43 minutes between documented vitals and safety check (2:00pm-3:43pm)
MR3, admission date 5/27/2023, treatment dates reviewed 8/7/23-8/21/23.
8/7/23 pretreatment pulse 111. No documentation of manual recheck or report to nurse per policy.
8/11/23 57 minutes between documented vitals check (5:37am-6:34am)
8/18/23 pretreatment pulse 104. No documentation of manual recheck or report to nurse per policy.
8/21/23 One hour between documented vitals check (9:32am-10:32am), one hour between documented safety check (9:33am-10:33am)
MR4, admission date 5/1/2023, treatment dates reviewed 8/14/23-8/25/23.
8/18/23 58 minutes between documented vitals check (8:03am-9:01am), 1hour and 27 minutes between documented safety check (7:34am-9:01am)
MR5, admission date 5/12/2023, treatment dates reviewed 5/27/23-8/29/23.
6/6/23 pretreatment pulse 59, 7:31am pulse 75, 8:02 pulse 58 8:31am pulse 56, 9:02am pulse 57, 9:32am pulse 56, 10:07am pulse 54. No documentation of manual recheck or report to nurse per policy.
8/5/23 8:02am pulse 54, 9:02am pulse 55, 9:33am pulse 54, 10:32am pulse 56, 10:44am pulse 58. No documentation of manual recheck or report to nurse per policy. One hour between documented vitals check (8:02am-9:02am),
8/19/23 pretreatment pulse 56, 8:33am pulse 54, 9:07am pulse 53. No documentation of manual recheck or report to nurse per policy.
Interview with the Director of Operations and Center Manager on August 31, 2023, at approximately 4:00pm confirmed findings.
Repeat deficiency, previously cited: 8/21/17, & 10/13/20
Plan of Correction:The Clinical Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
External POC Report Page 1 of 3
Patient Assessment and Monitoring Nursing Supervision and Delegation
Special emphasis will be placed on timeliness of monitoring and documentation of safety checks and vital signs including blood pressure and pulse rate. Ensuring patient monitoring and documentation is completed every 30 minutes or more as needed, not exceeding 45 minutes. The meeting will also review the importance of ensuring direct patient care (DPC) staff refers to RN team leader or charge nurse if patient presents with a heart rate below 60 beats per minute (BPM) or above 100 BPM. The RN staff will notify the Attending physician as necessary of all patients with any abnormal findings for further evaluation. RN staff will ensure interventions are documented as specified by the Physician, including re-checking of pulse rate.
The in-servicing of staff will be completed by 9/22/23, with documentation of the training on file at the facility.
The CM or designee will perform daily audits of 10% of patient treatment sheets utilizing a developed Plan of Correction Auditing tool to verify adherence to policy and procedure for 2 weeks. If compliance is noted, the audits will be completed 2 times/week for 2 weeks. If compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
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 reviews of medical records (MR), facility policy, and staff (EMP) interview, the facility failed to provide the necessary care and services to manage the patient's volume status for three (3) of five (5) in center dialysis records reviewed. (MR1, 2, & 5)
Findings included:
Review of facility policy on August 29, 2023, at approximately 1:30pm revealed:
"Patient Assessment and Monitoring...During Treatment...Machine Parameters and Extracorporeal Cricut...Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct and the prescribed flow is being delivered..."
Review of MR on 8/31/2023 at between approximately 9:30am and 2:00pm revealed:
MR1, admission date 7/31/2023, treatment dates reviewed 8/4/23-8/5/23.
8/4/23 Dialysis flow rate (DFR) to be 400 and treatment time to be 4 hours. Records revealed DFR to be run at 500 the entirety of the treatment (12:10pm-2:40pm). Treatment duration 2 hours and 30 minutes. Record failed to include explanation for early termination of treatment or increased DFR.
8/7/23 treatment time to be 4 hours, terminated 3 hours and 5 minutes after start. Record failed to include explanation for early termination of treatment.
8/21/23 Blood Flow Rate (BFR) ordered to be 250. Documentation- revealed BFR to be run at 350 the entirety of treatment (11:58am-3:58pm). Record failed to include explanation for increased BFR.
8/23/23 DFR ordered to be 400. Documentation revealed DFR to be run at 600 the entirety of the treatment (11:47am-3:44pm). Record failed to include explanation for increased DFR.
MR2, admission date 6/1/2023, treatment dates reviewed 7/24/23-8/11/23.
7/31/23 Blood Flow Rate (BFR) ordered to be 350. Documentation revealed BFR to be run at 250. Record failed to include explanation for decreased BFR.
MR5, admission date 5/12/2023, treatment dates reviewed 5/27/23-8/29/23.
8/5/23 Blood Flow Rate (BFR) ordered to be 400. Documentation revealed BFR to be run at 350. Record failed to include explanation for decreased BFR.
Interview with the Director of Operations and Center Manager on August 31, 2023, at approximately 4:00pm confirmed findings.
Plan of Correction:The Clinical Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
External POC Report Page 2 of 3
Patient Assessment and Monitoring Nursing Supervision and Delegation
Special emphasis will be placed on ensuring all physician treatment prescriptions contain specific orders or parameters for the BFR and DFR rate and is followed as prescribed. The meeting will also include the importance of reporting to the Charge Nurse/Team Leader if the dialysis prescription order is not achievable or reporting to the attending Physician for further orders if the treatment prescription cannot be carried out as ordered. The facility staff will also ensure that the attending physician is notified when the patient's prescribed BFR and DFR orders could not be met.
The in-servicing of staff will be completed by 9/22/23, with documentation of the training on file at the facility.
The CM or designee will perform daily audits of 10% of patient treatment sheets utilizing a developed Plan of Correction Auditing tool to verify adherence to policy and procedure for 2 weeks. If compliance is noted, the audits will be completed 2 times/week for 2 weeks. If compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
494.100(b)(2),(3) STANDARD
H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS
Name - Component - 00
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.
Observations:
Based on reviews of medical records (MR), facility policy, and staff (EMP) interview, the facility failed to ensure dialysis orders were followed for one (1) of one (1) home hemodialysis records reviewed. (MR7)
Findings included:
Review of MR on 8/31/2023 at between approximately 9:30am and 2:00pm revealed:
MR7, admission date 12/25/2021, treatment period reviewed 7/1/2023-8/28/2023. MR included an order for home hemodialysis dated 10/28/2022 specifying treatment "...4xweek, Mon, Tues, Wed, Fri..." Review of treatment sheets revealed home treatments being conducted on varying days week to week. Treatments that were conducted outside of ordered days as follows:
Saturday: 7/1/23, 7/8/23, 7/16/23, 7/29/23, 8/12/23, 8/26/23
Sunday: 7/2/23, 7/23/23, 7/30/23, 8/6/23, 8/20/23
Thursday: 7/6/237/20/23, 7/27/23, 8/17/23
MR revealed treatments conducted 3 times the weeks dated 7/9/23-7/15/23, 7/30/23-8/5/23, and 8/13/23-8/19/23.
Interview with Director of Operations on 8/31/23 at approximately 2:00pm revealed: "...We tell the patients to make the treatment work for them and accommodate their schedules. We should put a "special order" in the chart to clarify that..."
Interview with the Director of Operations and Center Manager on August 31, 2023, at approximately 4:00pm confirmed findings.
Plan of Correction:The Home Therapy Clinical Manager (HTCM) or designee re-educated all the direct patient care (DPC) staff on the following
External POC Report Page 3 of 3
policy:
Home Therapies Patient Treatment Record Keeping Home Therapies Patient Non-Adherence
Special emphasis will be placed on ensuring all physician treatment prescriptions, including dialysis orders is followed as prescribed. The meeting will also include the importance of the Home Therapy Registered Nurse (HTRN) reviewing the patient's home treatment records and ensuring that the patient is in compliance with their treatment regimen as prescribed by the Nephrologist. The HTRN will re-educate and address the patient and/or care partner if there are any issues or concerns.
The in-servicing of staff will be completed by 9/22/23, with documentation of the training on file at the facility.
The Home Therapy Clinical Manager or designee is responsible to review monthly all home treatment records ensuring patients are compliant with their treatment prescription. The Home Therapy Clinical Manager or designee will present a status report monthly, along with any applied interventions to correct the deficiency at each months Quality Assessment Improvement meeting. If compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
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