Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on May 6, 2025 through May 8, 2025, Fresenius Medical Care Parkview 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 re-certification survey conducted May 6, 2025 through May 8, 2025, Fresinius Medical Care- Parkview 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 observation during a tour of the facility, review of policy and procedure, and interview with the Facility Administrator, it was determined, that the facility failed to maintain a functional treatment environment by storing expired medical supplies (OBS#1).The facility failed to provide a sanitary environment to minimize the transmission of infectious agents within the facility (OBS#2).
Findings include:
A review of facility policy titled, "Emergency Medications, Equipment and Supplies " conducted on May 8, 2025, at approximately 9:50 AM states, " Emergency cart: The emergency cart must be: checked monthly or after use for contents, expiration dates, cleanliness and proper functioning of all equipment ... "
A review of facility emergency cart monthly checklist conducted on May 6, 2025, at approximately 9:45 AM, and observations of dialysis treatment and care area completed on May 6, 2025 between approximately 10:15 AM and 11:30 AM revealed the following:
Note: The last date the emergency cart was reviewed was on April 10, 2025.
OBS#1. A tour of the dialysis unit treatment area on May 6, 2025, at approximately 11:00 AM revealed the emergency cart contained two (2) expired Yankhauer sets with tubing. One (1) had an expiration date of 11/20/2020 and the other had an expiration date of 11/31/2020.
Review of facility Preferred Vendor Overview in lieu of a policy completed on 5/08/2025, at approximately 12:45 PM revealed: "Vendor Overview Pest Control: with last revision date of June 2019. TITLE: Pest Service Overview: Fresenius Medical Care North America has partnered with two national Pest Control companies to provide services to clinics...Covered Pest are pests that are covered for treatment, at no additional charge, during you recurring treatment..."
OBS#2 on 5/6/2025 at approximately 11:20 AM, a live brown insect (approximately 1 inch long) crawling on the floor was observed in the lab area.
An interview with the Charge Nurse conducted on May 6, 2025, at approximately 11:25 AM revealed last pest control treatment was a "few weeks ago".
An interview with the Facility Administrator conducted on May 8, 20205, at approximately 10:10 AM confirmed the above findings.
Plan of Correction:V 401
For immediate compliance on May 8, 2025, all expired items identified during the survey tour observation were discarded by the clinic manager (CM). All items were replaced with current, non-expired supplies. The Cm also called the facility exterminator on May 6, 2025, to schedule a pest control treatment visit to be completed by May 12, 2025.
For ongoing compliance, the CM or designee will in-service all direct patient care (DPC) staff and the Home Therapy (HT) staff on the following policy:
- Emergency Medications, Equipment and Supplies
Emphasis will be placed on ensuring that all medications and supplies are all within the current date for use. This includes anything that is stored in the emergency cart, including Yankhauer sets with tubing. The meeting reviewed that all supplies and medications must be rotated First in-First out (FIFO) when being stocked to ensure that items do not expire. The meeting will reinforce that staff must check the expiration date of medications and supplies monthly.
All facility staff will be educated by the CM on the policy:
- General Cleanliness and Infection Control Guidelines
The meeting will reinforce that the unit must be maintained in a clean, neat and orderly manner at all times. Staff will be informed that if they see any type of bugs/insects in any of the rooms, they are to notify the CM. The exterminating company will then be called to complete an additional treatment at the unit.
The in-services will be completed by May 28, 2025, and the education records will be on file in the facility.
The CM or designee will perform weekly audits for two (2) months. At that time, if one hundred percent (100%) compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) audit tool will be used for the audits.
The CM or designee will also complete daily audits for cleanliness 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 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: June 30, 2025
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 administrator, the facility did not follow its policy for patient assessment and monitoring for one (1) of ten (10) MRs reviewed, (MR # 9).
Findings include:
A review of facility policy titled "Patient Assessment and Monitoring" conducted on 05/08/2025 at approximately 1:30 PM AM states, "If the PCT/LPN (patient care technician/licensed practical nurse) note any changes or abnormal findings in the patient's condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the registered nurse must assess the patient. The nurse will notify the patient's physician of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The registered nurse ill assess/re-assess any findings addressed pre or during treatment as needed...Pre-Treatment: The direct patient care staff may obtain the following data...Blood Pressure: Record blood pressure. Verify: Systolic blood pressures greater than 180 mm/Hg and /or diastolic blood pressures greater than 100 mm/Hg. Systolic blood pressures less than or equal to 100 mm/hg systolic during treatment...Report to the nurse: Systolic blood pressures greater than 180 mm/Hg; Diastolic blood pressures greater than 100 mm/Hg; Blood Pressure less than or equal to 100 mm/Hg systolic...Reported by patient: Report to the nurse any complaints by the patient during treatment...Document any findings and interventions in the medical record..."
A review of MRs was conducted on 05/07/2025 at approximately 9:00 AM.
MR #9, Start of Care: 08/02/2023. Review of treatments sheets for 04/24/2025, 04/29/2025, 05/01/2025, 05/06/2025 revealed the following:
4/24/2024:
Pre-treatment blood pressure: BPSIT179/108, BPSTAND 186/108
PCT documented at 5:46 AM 179/108, "Treatment intiated without problem, Access Visible, Green AMP light, Denies Complaints; Patient Alert"
RN post assessment at 10:04 AM states, "tolerated tx well. VSS and AAOX3.completed treatment without any complaint, no sobx, cp, bleed or fall.UF removed 3.3kg ,pt left stable
There is no documentation of a recheck of the blood pressure and no documentation of RN acknowledgement/patient assessment or if any interventions were performed at the time of occurrence.
04/29/2024
Pre-treatment blood pressure: BPSIT 189/98, BPSTAND 172/110
PCT documented at 5:56 AM, B/P 189/98 ""Treatment intiated without problem, Access Visible, Green AMP light, Denies Complaints; Patient Alert"
PCT documented at 6:00 AM, BP 178/11 "Patient Alert; Access Visible"
PCT documented at 6:29 AM, 181/ 106
PCT documented at 6:57 AM, 172/105 "Patient Alert; Access Visible"
PCT documented at 8:22 AM, 164/102
PCT documented at 8:51 AM, 180/104
PCT documented at 9:20 AM, 152/100 "Patient Alert: Treatment discontinued without problems; Access Visible; come off early ama signed
PCT documented at 9:34 AM "NEW COMPLAINT OR OBSERVATIONS WHICH DEVELOPED DURING DIALYSIS: No new findings"
RN post assessment at 9:47 AM states, "pt. requested to come off early and signed off ama. pt educated and aware about the consequences of shortened tx. post vital signs stable. no complaints. left the unit stable/ambulatory.
There is no documentation of a recheck of the blood pressure and no documentation of RN acknowledgement/patient assessment or if any interventions were performed at the time of occurrence.
05/01/2025
Pre-treatment blood pressure: BPSIT 204/105, BPSTAND 171/105
PCT documented at 5:46 AM, 195/115 "Treatment intiated without problems, access visible; Green AMP light; Denies complaints; Patient Alert"
RN Evaluation at 6:08 AM, "No unusual findings noted"
PCT documented at 6:25 AM, 189/112
PCT documented at 6:58 AM, 185/112
RN post assessment at 12:32 PM, "pt tolerated tx. well post vital signs stable.no complaints.left the unit stable/ambulatory
There is no documentation RN acknowledgement/patient assessment or if any interventions were performed at the time of occurrence.
05/06/2025
Pre-treatment blood pressure: BPSIT 196/113, BP STAND 195/116
PCT documented at 5:50 AM, 163/100 "Lines Reversed; Patient Alert; Treatment Initiated without problem; Resting comfortably"
PCT documented at 7:56 AM 184/100
RN evaluation at 7:15 AM states, "pt denies any sob, cp, nvd, bleed or fall, hrr, lungs clr, uf as tolerated, no edema, AA0x3 ,access visible, pt orders as prescribed, will monitor
RN evaluation at 10:10 AM states " tolerated tc well, post vss, left the unit stable and ambulatory"
There is no documentation of a recheck of the blood pressure and no documentation of RN notification and therefore, no RN patient assessment or if any interventions were performed at the time of occurrence.
An interview with the Facility Administrator conducted on May 8, 20205, at approximately 10:10 AM confirmed the above findings.
Plan of Correction:V 504
To ensure compliance the CM or designee will in-service all the 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 the electronic cuff or using a manual cuff to take the BP. The meeting will reinforce the need to document the RN notification of the out-of-range BP as stated in the policy. 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
In-servicing will be completed by May 28, 2025. 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: June 30, 2025
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