Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on December 2, 2022, Fresenius Medical Care Pottstown, 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 December 2, 2022, Fresenius Medical Care Pottstown, was identified to have the following standard level deficiencies and was 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:
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based upon review of Dialysis Preventative Maintenance Work Orders and an interview with the Area Biomed Manager, it was determined the ESRD failed to ensure accurate documentation of Fresenius -2008 T hemodialysis machine annual and semi annual preventative maintenance, for six (6) out of twenty eight (28) hemodialysis machines reviewed, (HD Machine #4, HD Machine #9, HD Machine #10, HD Machine #13, HD Machine #17, HD Machine #19).
Dialysis Preventative Maintenance Work Orders for the time frame of December 2021-November 2022, for HD machine #1-HD Machine #28, were reviewed on 11/30/22, from approximately 1:00 PM-2:00 PM, revealing the following:
HD Machine #4:
Annual preventative maintenance completed on 4/26/2022 with clock hours (total operating hours of machine) documented as "1".
HD Machine #9:
Semi Annual preventative maintenance completed on 3/22/2022 with clock hours (total operating hours of machine) documented as "1".
HD Machine 10:
Annual preventative maintenance completed on 4/25/2022 with clock hours (total operating hours of machine) documented as "1".
HD Machine #13:
Semi Annual preventative maintenance completed on 1/28/2022 with clock hours (total operating hours of machine) documented as "1".
HD Machine #17:
Semi Annual preventative maintenance completed on 12/21/2022 with clock hours (total operating hours of machine) documented as "1".
HD Machine #19:
Annual preventative maintenance completed on 1/19/2022 with clock hours (total operating hours of machine) documented as "1".
An interview with the Area Biomed Manager on 11/30/22 confirmed the above documented clock hours were inaccurate and confirmed the above listed HD machines were not new to usage.
Plan of Correction:V 403
To ensure compliance, the Clinic Manager (CM) and Area Technical Operation Manager (ATOM) will re-educate the bio-medical technician (BMT) on:
- Dialysis Preventive Maintenance Work Orders
The meeting will focus on ensuring that the hemodialysis treatment machines are maintained and operated in accordance with the manufacturer's recommendations for use. This also includes that there is accurate and proper documentation of annual and semi-annual preventive maintenance.
In-servicing will be completed by December 20, 2022. Documentation of the training will be on file at the facility.
The CM, ATOM or designee will perform monthly audits for four (4) months. At that time, if one hundred percent (100%) compliance is maintained, 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.
Issues of non-compliance will be addressed by the ATOM with re-education and counseling.
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: January 12, 2023
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 upon policy and procedure review, medical record (MR) reviews, and an interview with Employee #1 (EMP#1), it was determined that the ESRD failed to ensure in center hemodialysis patient assessments, including blood pressures, to be assessed and documented at minimum every 45 minutes, while on hemodialysis as per facility policy for six (6) out of seven (7) in-center hemodialysis Medical Records reviewed (MR#1, MR#3-MR#7).
Findings include:
A review on 12/2/2022 at 3:00 PM of dialysis facility policy "Patient Assessment and Monitoring" revealed : "....Monitoring during Treatment...Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations, Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations..."
MR#1-MR#7 were reviewed on 12/2/2022 from 12:00 PM-2:00 PM, revealing the following:
MR#1 (Start of care: 11/25/2019):
Treatment Sheets from 11/18/2022-12/01/2022 revealed the following:
On 11/23/2022, between 18:36 and 20:02, 86 minutes in between monitoring.
On 12/1/2022, between 11:52 and 13:05, 73 minutes in between monitoring.
MR#3 (Start of care: 9/22/2022):
Treatment Sheets from 11/18/2022-12/01/2022 revealed the following:
On 11/23/2022, between 17:35 and 18:37, 62 minutes in between monitoring.
MR#4 (Start of care: 10/06/2022):
Treatment Sheets from 11/18/2022-12/01/2022 revealed the following:
On 11/18/2022, between 15:35 and 16:34, 59 minutes in between monitoring
On 11/21/2022, between 13:33 and 14:33, 60 minutes in between monitoring and between 14:33 and 16:34 , 124 minutes in between monitoring.
On 11/23/2022, between 14:47 and 16:08, 81 minutes in between monitoring.
On 11/26/2022, between 12:31 and 13:38, 67 minutes in between monitoring.
On 11/28/2022, between 15:03 and 16:45, 102 minutes in between monitoring
MR#5 (Start of care: 9/12/2022):
Treatment Sheets from 11/18/2022-12/01/2022 revealed the following:
On 11/28/2022, between 11:00 and 11:57, 57 minutes in between monitoring.
On 11/30/2022, between 08:06 and 09:02, 56 minutes in between monitoring, and between 11:00 and 11:56, 56 minutes in between monitoring.
MR#6 (Start of care: 1/24/2022):
Treatment Sheets from 11/18/2022-12/01/2022 revealed the following:
On 11/28/2022, between 12:33 and 13:37, 64 minutes in between monitoring and between 15:06 and 16:02, 56 minutes in between monitoring..
On 12/1/2022, between 15:30 and 15:31, 61 minutes in between monitoring.
MR#7 (Start of care: 10/25/2019):
Treatment Sheets from 11/18/2022-12/01/2022 revealed the following:
On 11/26/2022, between 15:30 and 16:34, 64 minutes in between monitoring.
On 12/1/2022, between 15:30 and 15:31, 61 minutes in between monitoring.
An interview with EMP#1 on 12/2/2022 at approximately 2:00 PM confirmed the above findings.
Plan of Correction:V 504
To ensure compliance the CM or designee will in-service all direct patient care (DPC staff on policy:
- Patient Assessment and Monitoring
The meeting will focus on ensuring that the patient is monitored every 30 minutes and not exceeding 45 minutes. This monitoring includes obtaining blood pressures (BP) with documentation of the BP.
The inservice will be completed by December 20, 2022, and the education records will be on file in the facility.
The CM or designee will perform daily flowsheet audits for two (2) weeks on twenty percent (20%) of the patients on each shift . 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, 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.
Completion date: January 12, 2023
|