QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE SHADYSIDE
Health Inspection Results
FRESENIUS MEDICAL CARE SHADYSIDE
Health Inspection Results For:


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey completed on May 2, 2018, Fresenius Medical Care Shadyside 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 conducted on April 27, 2018 through May 2, 2018, Fresenius Medical Care Shadyside 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:




494.30(a)(1)(i) STANDARD
IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS

Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.

When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.

Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.


Observations:

Based on review of agency policy, direct observation and interview with staff (EMP), it was determined that the facility failed to ensure staff prepared medications in a clean area, had removed PPE (gown) worn during initiation or discontinuation of dialysis treatments for one (1) of two (2) observed staff (EMP 3) preparing medication in the medication treatment area and that staff failed to follow facility policy for pre-filling medications.

Findings included:

CDC (Center for Disease and Control) MMWR (Morbidity and Mortality Weekly Report ) August 15, 2008 'Infection Control Requirements for Dialysis Facilities and Clarification Regarding Guidance on Parenteral Medication Vials' states " All parenteral medications should be prepared in a clean area separate from potentially contaminated items and surfaces. In hemodialysis settings where environmental surfaces and medical supplies are subjected to frequent blood contamination, medication preparation should occur in a clean area removed from the patient treatment area".


Review of facility policy "FMS-CS-IC-II-155-080A" on May 2, 2018, at approximately 11:30 AM revealed," ... Policy ... Personal protective equipment such as a full face shield or mask and protective eyewear with full face shield, fluid-resistant gowns and gloves will be worn to protect and prevent employees from blood or other potentially infectious materials to pass through to or reach the employees skin, eyes mouth, or other mucous membranes, or work clothes when performing procedures during spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis ... "

Review of facility policy "FMS-CS-IC-II-155-040A" on May 2, 2018, at approximately 11:30 AM revealed," ... Pre-Drawing Medications ... Medications may be pre-drawn up to 4 hours prior to administration ... Special Considerations when Preparing and Administering Medications ... Prepare medications for one patient shift a a time after the patients have arrived for treatment ... "

Review of facility policy "FMS-CS-IC-II-155-040C" on May 2, 2018, at approximately 11:30 AM revealed," ... Procedure ... Follow the procedure below to drawing medications from a vial: ... Step 1 ... Action ... Draw up a medication in a clean area ... Medication Administration Procedure ... Follow the steps in the table to prepare for administration of medication. Supplies: Medication to be administered ... PPE: Gloves, gown, safety glasses and mask or full face shield for IV medication administration into extracorporeal circuit or peripheral site ... Step 1 ... Action .. Wash hands, Apply PPE ... Step 3 ... Action ... Take the medication to the patient's chair or bedside ..."


During treatment floor observations on April 30, 2018, from 8:30 AM to 12:00 PM, surveyor had requested to observe mediation administration and EMP3 (RN) walked to the designated medication treatment area for team 1 and opened a locked drawer that contained syringes with medications that were pre-filled and labled by EMP3. Surveyor asked when these medications were completed and EMP3, replied,"This morning." This surveyor did not observe EMP3 drawing up medications during this time.

Interview with the clinic manager on April 30, 2018, at approximately 1:30 PM confirmed that the change over for the second shift begins about 9:00 AM and lasts until 12:30 PM and that the facility policy for pre-filling medications was 4 hours.

During observation on May 2, 2018 at approximately 10:40 AM, EMP 3 (RN) observed at designated medication treatment area for team 1 to prepare syringe containing Hectorol for medication administration for patient in station 13. RN continued to wear PPE (gown and face shield) worn previously when provided patient care, initiation/termination of hemodialysis treatment.

Interview with EMP3 (RN) immediately after the observation confirmed that she failed to remove the PPE (gown and face shield) when preparing medication in a clean area. EMP3 responded," I didn't know that ... never been told that before ..."

During interview on May 2, 2018 at approximately 11:30 AM, nurse manager confirmed medication treatment area was considered a clean area and that the nurse should have not been wearing PPE to draw up medication.






Plan of Correction:

By 5/18/2018 the Education Coordinator (EC) will re-educate all the Direct Patient Care (DPC) staff on the following Policy:
- FMS-CS-IC-II-155-040A Medication Preparation and Administration Policy
- FMS-CS-IC-II-120-040C Medication Preparation and Administration Procedure
- FMS-CS-IC-II-155-080A Personal Protective Equipment Policy
Emphasis of the education will be on ensuring that medications are prepared in a clean area following policy and that medications will be administered within 4 hours of being prepared. The in-service also reinforced that medications are prepared for one shift at a time per policy.
For ongoing compliance, the Clinic Manager (CM) or designee will complete daily visual observation audits for 2 weeks. If compliance is observed the audits will then be completed twice a week for 2 weeks. At that time if compliance is sustained the audits will be completed monthly following the Quality Assurance Improvement (QAI) auditing schedule. A plan of correction (POC) specific auditing tool will be used for the audit.
Staff found to be non-compliant will be referred for reeducation and counseling.
Results of the audit will be summarized by the CM who will report the audit results at the monthly QAI meetings for ongoing guidance and sustained compliance.
All training documentation and QAI Minutes will be available for review at the facility



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 and medical records (MR) and staff (EMP) interview, it was determined the facility failed to ensure staff assessed the patient's Intradialytic blood pressures every 30 minutes during dialysis treatment for five (5) of five (5) MRs reviewed (MR1 through MR5).

Findings Included:

Review of facility policy "FMS-CS-IC-I-110-133A"on May 2, 2018 at approximately 11:00 AM revealed, "... Policy ... Monitor the patient at the initiation of treatment and every 30 minutes, or more frequently as necessary ... Vital Signs/Mental Status ... Vital signs will be monitored at the initiation of treatment and every 30 minutes, or more frequently as necessary ... Documentation ... must be recorded in the patient's medical record within 15 minutes of being performed ..."

Review of MR1 on April 30, 2018, at approximately 12:30 PM. revealed: admission date of 11/10/2017, 9 treatment sheets reviewed dated between 4/2/18 and 4/20/18.
On 4/2/18, the patient was assessed at 12:24 PM, and was not assessed again until 1:07 PM [42 minutes between assessments]
On 4/13/18, the patient was assessed at 7:22 AM, and was not assessed again until 8:01 AM [39 minutes between assessments],
On 4/16/18, the patient was assessed at 10:02 AM, and was not assessed again until 22:16 AM [46 minutes between assessments]
On 4/18/18, the patient was assessed at 11:23 AM, and was not assessed again until 12:00 PM [37 minutes between assessments]
On 4/20/18, the patient was assessed at 7:00 AM, and was not assessed again until 7:46 AM [46 minutes between assessments]; then the patient was assessed at 9:00 AM, and was not assessed again until 9:55 PM [55 minutes between assessments]

Review of MR2 on April 30, 2018, at approximately 12:46 PM. revealed: admission date of 9/16/16, 9 treatment sheets reviewed dated between 4/2/18 and 4/20/18.
On 4/6/18, the patient was assessed at 2:15 PM, and was not assessed again until 3:07 PM [52 minutes between assessments]
On 4/9/18, the patient was assessed at 1:41 PM, and was not assessed again until 2:24 PM [43 minutes between assessments]; and the patient was assessed at 2:24 PM, and was not assessed again until 3:12 PM [38 minutes between assessments]
On 4/11/18, the patient was assessed at 2:23 PM, and was not assessed again until 3:04 PM [41 minutes between assessments]; and the patient was assessed at 10:58 PM, and was not assessed again until 11:42 AM [44 minutes between assessments]
On 4/16/18, the patient was assessed at 1:28 PM, and was not assessed again until 2:09 PM [41 minutes between assessments]
On 4/18/18, the patient was assessed at 12:00 PM, and was not assessed again until 12:41 PM [41 minutes between assessments]


Review of MR3 on April 30, 2018, at approximately 8:55 AM. revealed: admission date of 6/4/13, 6 treatment sheets reviewed dated between 4/4/18 and 4/20/18.
On 4/4/18, the patient was assessed at 12:23 PM, and was not assessed again until 1:05 PM [42 minutes between assessments]
On 4/11/18, the patient was assessed at 10:40 AM, and was not assessed again until 11:34 AM [56 minutes between assessments]; and the patient was assessed at 12:26 PM, and was not assessed again until 1:02 PM [36 minutes between assessments]
On 4/18/18, the patient was assessed at 10:16 AM, and was not assessed again until 10:50 AM [45 minutes between assessments]; and the patient was assessed at 11:03 AM, and was not assessed again until 11:41 AM [38 minutes between assessments]


Review of MR4 on April 30, 2018, at approximately 9:15 AM. revealed: admission date of 8/28/17, 8 treatment sheets reviewed dated between 4/2/18 and 4/20/18.
On 4/2/18, the patient was assessed at 12:44 PM, and was not assessed again until 1:39 PM [55 minutes between assessments]
On 4/6/18, the patient was assessed at 12:40 PM, and was not assessed again until 1:21 PM [40 minutes between assessments]
On 3/16/18, the patient was assessed at 8:23 AM, and was not assessed again until 9:00 AM [37 minutes between assessments]
On 4/2/18, the patient was assessed at 8:02 AM, and was not assessed again until 8:38 AM [36 minutes between assessments]; and the patient was assessed at 8:51 AM, and was not assessed again until 9:27 AM [36 minutes between assessments]


Review of MR5 on April 30, 2018, at approximately 9:40 PM. revealed: admission date of 1/26/16, 9 treatment sheets reviewed dated between 4/2/18 and 4/20/18.
On 4/11/18, the patient was assessed at 6:24 AM, and was not assessed again until 7:04 AM [40 minutes between assessments]
On 4/13/18, the patient was assessed at 7:24 AM, and was not assessed again until 8:20 AM [56 minutes between assessments]
On 4/16/18, the patient was assessed at 5:15 AM, and was not assessed again until 6:05 AM [50 minutes between assessments]; patient was assessed at 8:33 AM, and was not assessed again until 9:12 AM [39 minutes between assessments]
On 4/18/18, the patient was assessed at 5:24 AM, and was not assessed again until 6:03 AM [39 minutes between assessments]; patient was assessed at 7:04 AM, and was not assessed again until 7:44 AM [44 minutes between assessments]
On 4/20/18, the patient was assessed at 5:30 AM, and was not assessed again until 5:37 AM [37 minutes between assessments]


Exit conference on May 2, 2018, at approximately 2:30 PM with the nurse manager and facility administrator confirmed the above findings.







Plan of Correction:

By 5/18/2018 the EC will re-educate all the DPC staff on the following Policy:
- FMS-CS-IC-I-110-133A Monitoring During Patient Treatment Policy
The focus of the education will be on ensuring that the patients will be monitored every 30 minutes during their treatment.
For ongoing compliance, the CM or designee will complete daily visual observation audits for 2 weeks. If compliance is observed the audits will then be completed twice a week for 2 weeks. At that time if compliance is sustained the audits will be completed monthly following the QAI auditing schedule. A POC specific auditing tool will be used for the audit.
Staff found to be non-compliant will be referred for reeducation and counseling.
Results of the audit will be summarized by the CM who will report the audit results at the monthly QAI meetings for ongoing guidance and sustained compliance.
All training documentation and QAI Minutes will be available for review at the facility