Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed on March 26, 2021, Liberty Dialysis-Banksville LLC 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 unannounced onsite Medicare recertification survey completed on March 26, 2021, Liberty Dialysis-Banksville LLC 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 review of facility policy, medical records (MR), and staff (EMP) interview the facility failed to assess and/or manage patient's blood pressure for two (2) of eighteen (18) records reviewed with twelve (12) of those records being in center hemodialysis MR. (MR3-ICHD, MR18-ICHD).
Findings Included:
Review of facility policy on 3/26/21 at approximately 1:00 p.m. revealed: Patient Assessment and Monitoring...Procedure, Monitoring During Treatment-"Obtain blood pressure and pulse rate every 30 minutes or more as needed but do not exceed 45 minutes or per state regulations. Document matching parameters and safety checks every 30 [minutes] or more often as needed but do not exceed 45 minutes or per state regulations."
Review of MRs on 3/26/21 at approximately 10:30 a.m. to 1:15 p.m. revealed the following:
MR3, admission date of 3/8/16. Review of treatment records dated 3/2/21 through 3/20/21. Treatment sheet dated 3/9/21 revealed patient was assessed at 10:30 a.m. and patient was not assessed again until 11:26 a.m. (56 minutes between assessments).
MR18, admission date of 9/3/2020. Review of treatment records dated 3/3/21 through 3/17/21. Treatment sheet dated 3/17/21 revealed patient was assessed at 8:46 a.m. and patient was not assessed again until 10:04 a.m. (78 minutes between assessments).
An interview on 3/26/21 at 1:15 p.m. with EMP1 and Director of Operations confirmed the above findings.
Plan of Correction:V 543
To ensure compliance the clinic manager (CM) or designee will in-service all the direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
Emphasis will be placed on ensuring that patients must be monitored for their vital signs (VS) every thirty (30) minutes, not to exceed forty-five (45) minutes, during treatment. The meeting reviewed the need to document VS timely.
Inservicing will be completed by 4/15/2021. All training documentation is on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment Improvement (QAI) schedule. A plan of correction (POC) specific 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: 4/30/2021
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 review of facility policy, medical records (MR) and staff (EMP) interviews, it was determined that the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician for one (1) of eighteen (18) records reviewed with twelve (12) of those records being in center hemodialysis MR. (MR17-ICHD).
Findings Included:
Review of facility policy completed on 3/26/21 at approximately 1:15 p.m. revealed "...Policy: Patient Assessment and Monitoring...Machine Parameters and Extracorporeal Circuit: Check machine settings and measurements...Check prescribed blood flow rate 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...Document any findings and interventions in the medical record..."
Review of MRs on 3/26/21 at approximately 10:30 a.m. to 1:15 p.m. revealed the following:
MR17 revealed an admission date 1/28/17. Treatment sheets reviewed dated between 3/8/21 and 3/19/21. Patient orders dated 3/10/21 treatment time 3 hours and 30 minutes, blood flow rate (BFR) 400, dialysate flow rate (DFR) Manual 600 mL/min.
3/10/21 DFR ran at 800 the entire treatment time.
3/19/21 DFR ran at 800 the entire treatment time.
Interview on 3/26/21 at 1:15 p.m. with EMP1 and Director of Operations confirmed the above findings.
Repeat deficiency: 4/3/18.
Plan of Correction:V 544
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 all machine parameters are set within the physician prescribed limits. These parameters include the dialysate flow rate (DFR).
Inservicing will be completed by 4/15/2021. All training documentation is on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAI schedule. A POC specific 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: 4/30/2021
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on a review of facility policy, observation of the treatment area and an interview with staff (EMP) the facility staff did not follow facility policy as ensured by the medical director for one (1) of two (2) observations of discontinuation of dialysis with an arteriovenous fistula (AVF). Observation # 1.
Findings included:
Review of facility policy on 3/26/21 at approximately 1:00 p.m: Policy-Termination of Treatment with a 2008 Series Hemodialysis Machine using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer Step 4. "While closely monitoring the access site, return blood through the arterial line either by gravity or by applying gentle pressure to the saline bag. Do not apply excessive pressure on the saline bag; this may cause damage to the access..."
Observation of the treatment area was conducted on 3/22/21 from approximatley 9:20 a.m. to 11:20 a.m..
Observation #1 at station #24 on 3/22/21 at 10:35 a.m., the registered nurse (RN) was observed squeezing the saline bag during termination of treatment.
An interview on 3/26/21 at 1:15 p.m. with the Director of Operations indicated "it is our policy to apply gently pressure to the saline bag during the arterial rinseback, no other way to be sure all is returned."
Plan of Correction:V 715
On, 4/21/2021 the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the Medical Staff Bylaws and policies:
- Termination of Treatment with a 2008 Series Hemodialysis Machine using Arteriovenous Fistula of Graft and Optiflux Single Use Ebeam Dialyzer
The meeting will focus on the importance of the staff always following Fresenius Medical Care (FMC) policies. The meeting reviewed that a gentle pressure must be used when squeezing the saline bag during the arterial rinseback.
Minutes of the meeting with the Medical Director will be on file at the facility for review.
The Medical Director was informed at the meeting that the CM and the staff will receive education on the above policies by the CM or designee by 4/21/2021. The staff meeting will emphasize that the access site must be closely monitored when returning the blood by use of slow and gradual pressure on the saline bag when rinsing back the arterial line during termination of treatment. The meeting reviewed not to apply excessive pressure on the saline bag.
All training documentation will be on file at the facility.
The Medical Director was informed that the CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAI schedule. A POC specific audit tool will be used for the audits.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director.
The Medical Director was informed that staff found to be non-compliant will be re-educated and counseled.
Completion date: 4/30/2021
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