Initial Comments:
Based on the findings of an onsite unannounced recertification survey completed on April 22, 2022, 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 onsite unannounced recertification survey completed on April 22, 2022, Fresenius Medical Care Parkview, was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirement 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:
494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on observation of the clinical area, Center for Disease Control, (CDC) guidelines, and an interview with the facility clinical manager, the facility did not follow infection control practices regarding disposable gloves, performing hand hygiene, and touching the patient's equipment at the dialysis station three (3) of nineteen (19) observations conducted. (Observations #4(a)(b), and General observation #19).
Findings include:
On May 2, 2022, at approximately 11:04 a.m., a review of Center for Disease Control, (CDC), recommendations section entitled, IV.A.1. revealed that, "During the delivery of healthcare, avoid unnecessary touching of surfaces in close proximity to the patient to prevent both contamination of clean hands from environmental surfaces and transmission of pathogens from contaminated hands to surfaces." Reference; www.cdc.gov/infectioncontrol/guidelines/isolation/index.html.
Review of facility policy, FMS-CS-IC-II-155-090A, "Hand Hygiene" states: "Hands will be decontaminated using alcohol based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients...before performing any invasive procedures such as vascular access cannulation...Immediately after removing gloves....After contact with inanimate objects near the patient..."
Observation of the treatment area was conducted on April 21, 2022, from approximately, 9:45 a.m. - 12:00 p.m.
Observation #19-The Treatment area:
At approximately a general observation at approximately 11:45 a.m., revealed PF #7, moving between two Dialysis Stations closest to the right of the Nurses Station. PF #7 changed gloves three times and failed to wash or apply hand sanitizer in between glove changes.
Observation #4-Initiation/Access to the Fistula or Graft:
(a), PF #5, working station #14, wore gloves while palpating the cannulation sites but failed to change gloves before applying the antiseptic and inserting the cannulation needles.
(b), PF #7, working station #11, wore gloves while palpating the cannulation sites but failed to change gloves before applying the antiseptic and inserting the cannulation needles.
An interview with the clinical manager on April 22, 2022, at 3:00 p.m. confirmed the above findings.
Plan of Correction:V 113
To ensure compliance, the Clinic Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Hand Hygiene
- Initiation of Treatment Using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer
Special emphasis will be placed on ensuring that any time gloves are removed, hand hygiene is performed, before donning new gloves per policy. This includes changing gloves and performing hand hygiene after palpating the patient's access site and before cleaning the cannulation sites.
The in-servicing will be completed by May 18, 2022, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff 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, if compliance is sustained, the audits will then follow the monthly Quality Assessment Improvement (QAI) schedule. A plan of correction (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 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: May 31, 2022
494.30(c)(2) STANDARD
IC-CATHETERS:GENERAL
Name - Component - 00
(2) The "Guidelines for the Prevention of Intravascular Catheter-Related Infections" entitled "Recommendations for Placement of Intravascular Catheters in Adults and Children" parts I - IV; and "Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients," Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html
Observations:
Based on observation of the clinical area, company policy, and an interview with the facility clinical manager, the facility did not follow the "Guidelines for the Prevention of Intravascular Catheter-Related Infections," and handling infectious waste for one (1) of nineteen (19) observations conducted. (Observations #3).
Findings include:
A review was conducted of facility policy/procedure on April 28, 2022, at approximately 2:00 p.m. Policy ''Clinical Services' 'Changing the Catheter Dressing' 'Background' states "Catheter related infections are one of the leading causes of hospitalization and death. Strict infection control practices and adherence to the catheter dressing change procedure is essential to prevent serious complications."
Observation of the treatment area was conducted on April 21, 2022, from approximately, 9:45 a.m. - 12:00 p.m.
Observation #3-Discontinuation with the Central Venous Catheter, (CVC):
PF #8, working station #16, opened a clean field of supplies on the tray connected to the Dialysis chair, and later proceeded to disinfect the CVC connections with antiseptic pads. The contaminated pads were discarded onto the clean field with sterile/clean supplies not yet used.
An interview with the clinical manager on April 22, 2022, at 3:00 p.m. confirmed the above findings.
Plan of Correction:V 146
The CM or designee re-educated all the DPC staff on the following policy:
- Changing the Catheter Dressing
Special emphasis was placed on ensuring that no dirty/contaminated items are placed on the patient's catheter care clean field of supplies. This includes the contaminated antiseptic pads used to clean the catheter site.
The in-servicing of staff and patients will be completed by May 18, 2022, with documentation of the training 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 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 QAI 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 QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: May 31, 2022
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