Initial Comments:
Based on the findings of an onsite unannounced state relicensure survey completed on November 18, 2024 through November 20, 2024, Fresenuis Medical Care -Logan was found to be in compliance with the requirements of 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 re-certification survey conducted November 18, 2024 through November 20, 2024, Fresinius Medical Care- Logan 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:
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on observations, agency policy, and interview with the facility staff, it was determined that the facility staff did not follow facility policy to maintain the quality and storage of supplies for two (2) of four (4) observations. Observations #1 and #2
Findings include:
Policy titled "Storage of Supplies" states, " ...Supplies must be rotated First In-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date ... "
Observation tour of medication area near the nurse ' s station and supply carts in treatment area was conducted on November 19, 2024 from approximately 1:40PM until approximately 3:10PM revealed:
The following supplies were expired:
Observation #1 (POD #1)
(Located in the second drawer of the storage area in front of the nurse ' s station next to the clean sink)
One (1) Box of NIPRO SafeTouch Tulip Safety Fistula Needles (17G 1.5 x 300mm) (17G x 1 " HC-30W), Lot 17L01B, Expired 11/30/2022 (approximately 16 needles remaining)
(Located on a portable cart next to the fire exit near station #1, and across from the dirty sink)
One (1) Container of E-Z Check Blood Leak Test Strips (unopened), Lot 101062, Expired 5/31/2024
(Located in storage area on the other side of the nurse ' s station across from station #10)
Six (6) Tempa Dot Single-Use Clinical Thermometers, Lot 07027, Expired 5/18/2022
Observation #2 (POD #2)
(Located in supply cabinets in front of the nurse ' s station)
One (1) Box of NIPRO SafeTouch Tulip Safety Fistula Needles (16G 1.6 x 300mm) (16G x 1 " HC-30W), Lot 19A02A, Expired 12/31/2022 (approximately 17 needles remaining)
One (1) Box of NIPRO SafeTouch Tulip Safety Fistula Needles (17G 1.5 x 300mm) (17G x 1 " HC-30W), Lot 16H04C, Expired 7/31/2021 (approximately 21 needles remaining)
Tempa Dot Single-Use Clinical Thermometers, Lot 07036, Expired 6/12/2022 (Thirty-Six (36) Sheets - 4 per sheet)
An interview conducted with the facility administrator on November 20, 2024 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:For immediate compliance all expired items found at the time of the survey were removed and discarded on November 19, 2024, by the Clinic Manager (CM) and the bio-medical technician (BMT).
For ongoing compliance, the CM will in-service all direct patient care (DPC) staff on the following policy:
- Storage of Supplies
Emphasis will be placed on ensuring that all supplies, including those stored at the nurse's station and on the treatment floor supply cart and in the storeroom, are all within the current date for use. The meeting reviewed that supplies must be rotated First In – First Out when restocking. Staff will also be reminded that any supplies must be checked for the expiration date before using the item.
The inservice was completed by December 20, 2024, and the education records will be on file in the facility.
The CM and/or designee will conduct daily audits for two (2) weeks. If one hundred percent (100%) compliance is observed, then audits will continue weekly x 2 weeks. If compliance has been sustained audits will continue monthly per Quality Assessment and Performance Improvement (QAPI) program. 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 counseled.
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.
494.80(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 a review of facility policy, medical records (MR), and an interview with the facility staff, the facility did not follow its policy for patient assessment and monitoring for two (2) of seven (7) MRs reviewed, (MR # 7 and 9).
Findings include:
A review of facility policy titled "Patient Assessment and Monitoring" conducted on November 20, 2024 at approximately 12:00 PM states, "During Treatment:...the following steps below for monitoring patient and machine parameters during treatment: Record blood pressure: Report to the nurse: Systolic blood pressures greater than 100mm/Hg, Diastolic blood pressure greater than 100mm/Hg, and blood pressure less than or equal to 100mm/Hg/systolic..."
A review of MRs and treatment sheets was conducted on 11/19/2024 from approximately 8:30am and on 11/20/2024 from approximately 8:35am until approximately 10:15am.
MR #7. Admission Date: 1/5/2023. Dialysis Treatment Order Date: 8/6/2024; Frequency: Three (3) days per week; Treatment Duration: 4 hours and 30 minutes. Review of treatments sheets for 11/9/2024 and 11/14/2024 revealed the following:
Treatment Record for 11/9/2024:
Pre-Treatment Blood Pressure (BP) sitting 162/84, documented by PCT.
12:00pm BP 184/106 "UF On: Access visible; Green AMP Light; Denies complaints; Patient alert; Started" documented by RN.
12:36pm BP 196/92 " Access visible; Green AMP Light; Denies complaints; Patient alert " documented by PCT.
1:02pm BP 147/91 " UF On: Access visible; Denies complaints; Patient alert " documented by RN.
1:32pm BP 166/88 " UF On: Access visible; Denies complaints; Patient alert " documented by RN.
2:00pm BP 166/88 " UF On: Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
2:32pm BP 199/82 " UF On: Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
3:06pm BP 213/74 " UF On: Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
3:35pm BP 180/110 " UF On: Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
4:06pm BP 209/96 " UF On: Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
Post-Treatment sitting B/P 145/105 documented by PCT.
RN documented at 4:46pm Comments: " Dialysis completed successfully. Weight reduced by less than 4kg. Patient is AAO x3. Patient discharged home in a stable state " .
No evidence documented that RN was notified during the last two (2) hours of treatment of BP readings out of facility parameters and no evidence that RN reviewed the post treatment blood pressures.
Treatment Record for 11/14/2024:
Pre-Treatment Blood Pressure (BP) sitting 151/77, documented by PCT.
12:30pm BP 208/114 documented by RN.
1:34pm BP 198/60 " Denies complaints; Access visible " documented by PCT.
2:04pm BP 192/68 " Green AMP Light; Denies complaints; Access visible " documented by PCT.
2:37pm BP 138/99 " UF On; Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
3:01pm BP 197/86 " Denies complaints; Access visible " documented by PCT.
3:33pm BP 214/107 documented by PCT.
3:34pm BP 167/107 " UF On; Resting comfortably; Access visible; Denies complaints; Patient alert " documented by PCT.
4:00pm BP 188/101 " UF On; Resting comfortably; Access visible; Green AMP Light; Denies complaints; Patient alert " documented by PCT.
4:30pm BP 200/103 " Resting comfortably; Access visible; UF Off; Patient alert; Green AMP Light; Denies complaints; Treatment discontinued without problem; Patient tolerated treatment well " documented by PCT.
Post-Treatment sitting B/P 175/103 documented by PCT.
RN documented at 5:00pm Comments: " Dialysis completed successfully. Weight reduced by less than 3.8kg. Patient is AAO x3. Patient discharged home in a stable state " .
No evidence documented that RN was notified of BP readings out of facility parameters during treatment and no evidence that the RN reviewed post treatment blood pressure. No evidence documented that BP was checked at 1:00PM.
MR #9, Admission Date: 8/24/2024. Dialysis Treatment Order Date: 10/21/24; Frequency: Three (3) days per week; Treatment Duration: 4 hours and 30 minutes. Review of treatments sheets for 11/13/2024, revealed the following:
Treatment Record for 11/13/2024:
Pre-Treatment Blood Pressure (BP) sitting 119/53 at 3:40pm, documented by PCT.
3:50 pm BP: 92/69 with Comment: UF on; treatment initiated without problem; access visible; Green AMP light; Denies complaints; pt alert: pt offered no co bp low; started hep pump documented by PCT.
4:02 pm BP: 106/61..Comment: Green Amp Light, denies complaints, access visible, no co..documented by PCT.
4:37 pm BP: 88/49.. Comment: "Denies Complaints, Access Visible, bp low uf off" documented by PCT.
5:00pm BP 87/48 ..Comment: "Denies Complaints; Access Visible; pt feels ok" documented by PCT.
5:33pm BP 101/56..Comment: "Denies Complaints; Access Visible; bp still low" documented by PCT.
6:02pm BP 94/47..Comment: "Denies Complaints; Access Visible; bp low uf on "documented by PCT.
6:32pm BP 100/54..Comment: "Denies Complaints; Access Visible; no co" documented by PCT.
7:02 pm BP 97/47..Comment: "Denies Complaints; Access Visiblle; no co" documented by PCT.
7:33pm BP 100/54..Comment:" Denies Complaints; Access Visible; no co" documented by PCT.
8:02 pm BP 97/47 ..Comment: "Denies Complaints; Access Visible; no co" documented by PCT.
8:03 pm BP 97/62..Comment : "Denies Complaints; Access Visible " documented by PCT.
8:28 pm BP 122/52..Comment: "Denies Complaints; Access Visible; tx complete.. ended "documented by PCT.
RN documented at 8.28pm Comments: "Patient tolerated treatment uneventfully. He had no complaints during or post treatment. AAO x3. VSS. CVC lines flushed, cleaned and capped. Patient ambulated from unit without assistance."
No evidence documented that RN was notified of BP readings out of facility parameters during treatment.
An interview conducted with the facility administrator on November 20, 2024 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all the direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
The in-service will focus on the staff ensuring that the registered nurse (RN) is informed of any vital signs (VS) outside of parameters per policy and/or physician orders. This includes blood pressures which are not in the acceptable range at any time pre, post or during treatment. The staff will also be re-educated to verify the BP by repositioning electronic cuff or to use a manual cuff to take the BP. The meeting will reinforce the need to document the RN notification of the out-of-range BP. The meeting will re-educate the RNs that an assessment of the patient needs to be completed with documentation of the evaluation and any interventions taken along with a follow-up assessment after the intervention. The staff will also be instructed to document physician notification as indicated
Inservicing will be completed by December 20, 2024. 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 100% 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 QAPI 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 QAPI Committee at the monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion date: 1/10/2025
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