QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE - NEW BLOOMFIELD
Health Inspection Results
FRESENIUS MEDICAL CARE - NEW BLOOMFIELD
Health Inspection Results For:


There are  11 surveys for this facility. Please select a date to view the survey results.

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Initial Comments:


Based on the findings of an on-site, unannounced Medicare recertification survey conducted on March 19, 2024 through March 20, 204, Fresenius Medical Care - New Bloomfield, 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 on-site, unannounced Medicare recertification survey conducted on March 19, 2024 through March 20, 204, Fresenius Medical Care - New Bloomfieldwas identified to have the following standard level deficiencies that were determined to be in compliance with the following requirements of 42 CFR, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.




Plan of Correction:




494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL

Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.



Observations:


Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Clinical Manager, the facility failed to ensure staff followed standard infection control precautions by emptying the prime waste receptacle prior to disinfecting the dialysis station for one (1) of two (2) observations of 'Cleaning and Disinfection of the Dialysis Station' (Observation #2).


Findings:

A review was conducted of facility policy titled, 'Prime Bucket Disinfection' on March 20,, 2024 at approximately 1:00 p.m. 'Prime Bucket Disinfection' policy, reads, "Procedure: Step #1: Dispose of saline solution down any marked dirty sink or utility room hopper; Step #2: Clean all surfaces of the priming bucket; Step #3: Return clean priming bucket or approved receptacle to the machine"

The CDC 'Checklist: Dialysis Station Routine Disinfection' 'Part A: Before beginning routine disinfection of the dialysis station' includes but is not limited to "Ensure that the priming bucket has been emptied", ..........., "remove gloves and perform hand hygiene". Part B: Routine disinfection of the dialysis station-After the patient has left station' includes but is not limited to "Wear clean gloves". "Apply disinfectant to all surfaces in the dialysis station .....".

*Note: Facility Procedure does not include "Emptying prime waste receptacle if present on the machine"/"Remove gloves, hand hygiene, don clean gloves" before "using disinfectant soaked cloth/wipe to visibly wet all machine ........" as listed in sequence on the 'Centers for Medicare & Medicaid Services ESRD Core Survey Version 1.6" surveyor observation form.

Observations conducted in the patient treatment area on March 19, 2024 between approximately 10:20 a.m. and 11:41 a.m. and on March 20, 2024 between approximately 9:55 a.m. and 10:06 a.m. revealed the following:

Cleaning and Disinfection of the Dialysis Station Observation #2 :On 3/19/2024 at approximately 11:36 a.m. while observing 'Cleaning and Disinfection of the Dialysis Station' observation #2 of 2, employee #11 failed to empty prime waste receptacle after removing all bloodlines and disposable equipment and prior to disinfecting the dialysis station.


An interview with the facility Clinical Manager on March 20, 2024 at approximately 2:00 p.m. confirmed the above findings.





Plan of Correction:

V 122

To ensure ongoing compliance the Clinic Manager (CM) or designee will in-service all the direct patient care (DPC) staff on the following policies:

- Prime Bucket Disinfection
- Cleaning and Disinfection of the Dialysis Station

The meeting will focus on ensuring that the prime waste bucket is emptied in a marked dirty sink prior to the cleaning and disinfection of the dialysis machine and station. The meeting reinforced that all internal and external surfaces of the prime waste bucket must be cleaned and disinfected before returning the unit to the machine.

The in-service of staff will be completed by April 5, 2024, with documentation of the training on file at the facility.

The CM or designee will perform random daily audits of cleaning and disinfection of the dialysis station for two (2) weeks. At that time if one hundred percent (100%) compliance is observed, the audits will then be completed 2 times/week for 2 weeks. At that time, if 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.

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: May 3, 2024



494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE

Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children

I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.

II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.

Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.

VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].





Observations:


Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility Clinical Manager, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters, for one (1) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' observations (Observations #2) and for one (1) of two (2) 'Discontinuation of Dialysis with Central Venous Catheter' observations. (Observation #2 )

Findings:

A review was conducted of facility policy titled, 'Changing the Catheter Dressing Procedure' on March 20, 2024 at approximately 1:30 p.m. 'Changing the Catheter Dressing Procedure', section, 'Removal of Dressing and Inspection of Site' reads, "Follow the steps below to remove a catheter dressing and inspect the exit site before initial of dialysis treatment: Step 1: Place an underpad under catheter limbs to protect work area and clothing; Step 2: Apply mask to patient and caregiver to help prevent contamination by airborne nasal..."

A review was conducted of facility policy titled, 'Termination of treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' on March 20, 2024 at approximately 1:30 p.m. 'Termination of treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' section, 'Prior to Termination Preparation' reads, Follow the steps below to prepare for the termination of dialysis::... Step 3: Don gown and full-face shield with mask (or protective eyewear
with full side shield and mask)... "


Observations conducted in the patient treatment area on March 19, 2024 between approximately 10:20 a.m. and 11:41 a.m. and on March 20, 2024 between approximately 9:55 a.m. and 10:06 a.m. revealed the following:

Central Venous Catheter (CVC) Exit Site Care Observation #2 :On 3/19/2024 at approximately 11:05 a.m. while observing 'Central Venous Catheter (CVC) Exit Site Care' observation #2 of 2, for patient #6, station #8 employee #4; employee #4 failed to ensure face mask on patient # 8 was above nose throughout the procedure.

Discontinuation of Dialysis with Central Venous Catheter Observation #2 :On 3/20/2024 at approximately 10:00 a.m. while observing 'Discontinuation of Dialysis with Central Venous Catheter' observation #2 of 2, for patient #8, station #2 employee #4; employee #4 failed to ensure face mask on patient # 8 was above nose throughout the procedure.

An interview with the facility Clinical Manager on March 20, 2024 at approximately 2:00 p.m. confirmed the above findings.






Plan of Correction:

V 147

For ongoing compliance, the CM will in-service all DPC staff on policies:

- Changing the Catheter Dressing Procedure
- Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer

The in-service will focus on the staff ensuring that the policy for catheter care and termination of treatment with a catheter is always followed. This includes ensuring that the staff and the patient are wearing their mask properly with the nose and mouth covered by the mask.

The in-service of staff will be completed by April 5, 2024, with documentation of the training on file at the facility.

The CM or designee will perform random daily audits of cleaning and disinfection of the dialysis station for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks. 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: May 3, 2024