QA Investigation Results

Pennsylvania Department of Health
DIALYSIS CLINIC, INC.
Health Inspection Results
DIALYSIS CLINIC, INC.
Health Inspection Results For:


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Initial Comments:


Based on the findings of an onsite unannounced Medicare Recertification survey completed on March 9, 2023, Dialysis Clinic, Inc.-Washington 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 9, 2023, Dialysis Clinic, Inc.-Washington 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:




494.90(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/procedure, standing order, medical records (MR), and staff (EMP) interview, the facility failed to assess and/or manage patient's blood pressure/volume status for three (3) of five (5) incenter hemodialysis medical records reviewed (MR1, MR2, MR3).

Findings included:

Review of facility policy on 3/9/23 revealed: " Subject: Patient Monitoring...Vital Signs: 1. BP (blood pressure) and pulse to be taken and recorded on initiation of treatment, every 30 minutes, and prn (as needed) if patient symptomatic. 2. Document S/S (signs/symptoms) and medication/interventions given...for every event during treatment. A response to every intervention should be documented in a time appropiate manner...Blood Pressure: 1. Physician to be notified if: 2. The BP stays below 90 systolic and the patient is symptomatic and unresponsive to ordered IV fluid or medication..."

Review of facility "Yearly Standing Orders" on 3/9/23 revealed the following: " ...7. Fluid Replacement NSS (Normal Saline Solution) up to 500 mL (milliliters) IV (intravenously) per treatment...8. Medications: ...NACL (Sodium Chloride) 23.4 % IV not to exceed 10 mL per treatment prn severe muscle cramps/hypotension to be administered 3 mL every 20 minutes...9. Vital Signs: ...Notify Nephrologist: ...Systolic BP < 90 or > 220, Diastolic BP < 40, or > 120..."

Review of MR1 - MR5 on 3/9/23 between approximately 10:00 AM and 1:00 PM revealed the following:

Review of MR1: Admission 11/19/2021. Review of incenter hemodialysis treatment flow sheets from 2/20/2022 to 3/6/2023 Intradialytic monitoring revealed:
2/20/2023, 1:18 PM - BP (blood pressure) 172/84, 1:36 PM - BP 136/67, 36 point drop in systolic BP between 30 minute check.
3/1/2023, 10:17 AM - BP 189/79, 10:47 AM - BP 159/72, 30 point drop in systolic BP between 30 minute check.
3/3/2023, 10:54 AM - BP 167/71, 11:24 AM - BP 137/66, 30 point drop in systolic BP between 30 minute check.
3/6/2023, 10:41 AM - BP 152/79, 11:12 AM - BP 112/59, 40 point drop in systolic BP between 30 minute check.
There was no documented evidence of intervention/re-assessment for patient MR1 systolic blood pressure drops/volume status between 30 minute checks for above treatment flowsheets reviewed.

Review of MR2: Admission 8/5/2020. Review of incenter hemodialysis treatment flow sheets from 2/13/2022 to 3/6/2023 Intradialytic monitoring revealed:
2/13/2023, 7:24 AM - BP (blood pressure) 163/68, 7:54 AM - BP 141/67, 22 point drop in systolic BP between 30 minute check.
2/17/2023, 9:29 AM - BP 148/67, 9:59 AM - BP 115/51, 33 point drop in systolic BP between 30 minute check.
2/24/2023, 10:02 AM - BP 174/78, 10:27 AM - BP 142/59, 32 point drop in systolic BP between 30 minute check.
There was no documented evidence of intervention/re-assessment for patient MR2 systolic blood pressure drops/volume status between 30 minute checks for above treatment flowsheets reviewed.

Review of MR3: Admission 11/28/2022. Review of incenter hemodialysis treatment flow sheets from 2/20/2022 to 3/6/2023 Intradialytic monitoring/post treatment assessment revealed:
2/22/2023, 10:02 AM - BP (blood pressure) 193/97, 10:19 AM - BP 137/84, 56 point drop in systolic BP between 30 minute check.
2/24/2023, Post BP 82/54.
2/27/2023, 7:30 AM - BP 154/58, 8:00 AM - BP 124/39, 30 point drop in systolic BP and Diastolic BP below 40, 9:30 AM - BP 167/61, 10:00 AM - BP 127/63, 40 point systolic BP drop between 30 minute checks.
3/3/2023, 8:59 AM - BP 156/70, 9:29 AM - BP 121/43, 35 point drop in systolic BP between 30 minute check.
3/6/2023, 7:32 AM - BP 129/57, 8:05 AM - BP 100/48, 29 point drop in systolic BP between 30 minute check.
There was no documented evidence of intervention/re-assessment for patient MR3 systolic/diastolic blood pressure drops/volume status between 30 minute checks for above treatment flowsheets reviewed nor was there documented evidence of intervention/assessment of patient MR3 for low BP post treatment on 2/24/2023.

An exit conference was conducted on 3/9/2023 with the facility Clinical manager (EMP2) and Clinical educator (EMP8) at approximately 2:00 PM. Above findings were reviewed.





Plan of Correction:

543
Policy and Procedure H-30 "Patient monitoring" will be updated to include symptoms and interventions to be documented with significant vital sign changes. This updated policy will be reviewed and approved by the governing body, and prior to education with staff. Once approved, all clinical staff will be educated on the updated policy "Patient Monitoring" policy H30 and Policy "Clinic Reporting Parameters" H-42 by the nurse educator or designee. All clinical staff will sign acknowledgment of understanding policies H-30 and H-42 in regards to the requirement of assessing each patient's vital signs at least every 30 minutes during their dialysis treatments, and while assessing the patient as being symptomatic or not determining if any of the vital signs need any interventions to be considered including notification of a registered nurse, and completion of all such documentation. A copy of acknowledgment will be placed in the respective employee files. This training will be completed and documentation placed in employee files by 4/7/23 for all staff.
The Nurse Educator, or designee, will audit 50% of the daily treatments for 1 week (the week of April 10th) to ensure staff is following the policy with emphasis on documentation of documentation of vital sign monitoring and significant changes noted. If standards are met, 20% of the weekly treatments will be audited weekly for 4 weeks (The weeks of 4/17/23, 4/24/23, 5/1/23, and 5/8/23). If standards are met, 10% of the monthly treatments will be audited for three (3) months. If standards are met, 10% of one month's treatments will be audited semi-annually. The respective audit results will be reviewed at monthly QAPI/GB meetings. Governing Body will determine frequency of future audits based upon compliance



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 one (1) of five (5) incenter patient medical records reviewed. (MR2).

Findings Included:

Review of facility policy on 3/9/23 revealed: " Subject: Patient Monitoring...Each patient and machine shall be monitored during each dialysis treatment...Machine Settings: ...Record when changes are made, along with the reason for the change..."

Review of MR1 - MR5 on 3/9/23 between approximately 10:00 AM and 1:00 PM revealed the following:

Review of MR2: Admission 8/5/2020. Physician order for BFR (blood flow rate) 350 ml/min (milliliters/minute) for period reviewd. Review of incenter hemodialysis treatment flow sheets from 2/13/2022 to 3/6/2023 Intradialytic monitoring revealed:
2/24/2023, from 8:26 AM to 10:27 AM, BFR at 300 ml/min. MR did not contain evidence of why BFR was not at rate as ordered.
3/6/2023, from 7:57 AM to 10:57 AM BFR at 325 ml/min. MR did not contain evidence of why BFR was not at rate as ordered.

An exit conference was conducted on 3/9/2023 with the facility Clinical manager (EMP2) and Clinical educator (EMP8) at approximately 2:00 PM. Above findings were reviewed.









Plan of Correction:

544
Policy and Procedure H-30 "Patient monitoring" and H-31 "Patient Care Pre and Post Treatment" will be updated to include monitoring of the BFR ordered versus the BFR the patient is running at during treatment with documentation of why they do not match, and any interventions that occur, including notification of the registered nurse. These policies will be reviewed and approved by the governing body after updating and prior to education with staff. Once approved, all clinical staff will be educated on the "Patient Monitoring" policy H30 and "Patient Care Pre and Post Treatment" H-31 by the nurse educator or designee. Training will include the responsibility to document the reason when unable to achieve the prescribed BFR and notification to the registered nurse. The nurse will be responsible for notifying the physician if the prescribed BFR cannot be prescribed for 3 consecutive treatments. This training will be completed and documentation placed in the employee files by 4/7/23 for all staff.
The "In-Center Hemodialysis Standing Orders" will be reviewed with all clinical staff with particular emphasis on physician orders for machine settings to include "blood flow rate (BFR)". All clinical staff will review and sign acknowledgement of understanding of standing orders. A copy of the acknowledgement will be placed into the respective employee education file. This will be completed by the nurse educator or designee and in employee files by 4/7/23.
The Nurse Educator or designee will audit 50% of the daily treatments for 1 week (the week of April 10th) to ensure staff is following the policy with emphasis on documentation of physician orders not being met and notifying the physician per policy. If standards are met, 20% of the weekly treatments will be audited weekly for 4 weeks (the week of 4/17/23, 4/24/23, 5/1/23, and 5/8/23). If standards are met, 10% of the monthly treatments will be audited for three (3) months. If standards are met, 10% of the treatments will be audited semi-annually. The audit results will be reported and reviewed at monthly QAPI and Governing Body meetings.