Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 15, 2021 through March 17, 2021, Fresenius Kidney Care Pennsylvania Dialysis Center Reading, was identified to have the following standard level deficiency and is determined to be in substantial compliance with the following 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:
494.62(d)(3) STANDARD
ESRD Patient Orientation Training
Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.
Observations:
Based upon medical record (MR) review, policy and procedure review, and an interview with the facility nurse manager, it was determined the facility failed to ensure documentation of patient education for emergency evacuation within the first month of admission to the facility for three (3) out of fifteen (15) MR's reviewed (MR#10-MR#12).
Findings include:
Review of Policy "Patient Education" on 3/17/2021 at approximately 12:00 PM states " Patients must be educated by the IDT according to the following schedule: Fire/Emergency Evacuation and Take Off Procedures: Within the 1st month for new patients...."
Review of MR#10 (Start of care (SOC) 02/06/2021) on 3/17/2021 at approximately 11:00 AM revealed no documentation of education for Fire/Emergency Evacuation and Take Off Procedures.
Review of MR#11 (SOC: 12/10/2020) on 3/17/2021 at approximately 11:20 AM revealed no documentation of education for Fire/Emergency Evacuation and Take Off Procedures.
Review of MR#12 (SOC: 12/11/2020) on 3/17/2021 at approximately 11:40 AM revealed no documentation of education for Fire/Emergency Evacuation and Take Off Procedures.
An interview with the facility Nurse Manager on 03/17/2021 at approximately 1:00 PM confirmed the above findings.
Plan of Correction:On 3/17/21, the CM added the emergency evacuation acknowledgement of education to the admission packet.
By 3/26/21 the CM will hold a staff meeting, elicit input, and reinforce the expectations and responsibilities of the facility staff on the Patient Education policy. Any staff member not available for the meetings will be educated one on one as soon as they return to work.
Emphasis was placed on:
Patients must be educated by the Inter Disciplinary Team (IDT), according to the following schedule: Fire/Emergency Evacuation and Take Off Procedures: Within the 1st month for new patients and quarterly for existing patients.
Effective 3/29/21, the CM or designee will audit 100% of the new patient records monthly x 3 months to ensure patient education including but not limited to, Fire/Emergency Evacuation and Take Off Procedures has been completed within the first month of dialysis. Ongoing compliance will be monitored using the medical record audit tool.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly. The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and
take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 4/30/21
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 15, 2021 through March 17, 2021, Fresenius Kidney Care Pennsylvania Dialysis Center Reading, 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) 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 upon observation, policy and procedure review, and an interview with the facility nurse manager, it was determined the facility failed to ensure hand hygiene post Central Venous Catheter (CVC) dressing removal and prior to cleaning the access site for one (1) of two (2) observations made. (Observation #1); failed to ensure donning of gloves prior to handling saline primed dialysate lines for one (1) of two (2) observations made. (Observation #2).
Findings include:
Review of policy "Changing a Central Venous Catheter Dressing" on 3/17/2021 at approximately 12:00 PM states " 5. Inspect and remove the old dressing....discard dressing and remove gloves. Perform hand hygiene..."
Observation #1: On 3/15/2021 at approximately 10:00 AM, PCT (Patient Care Technician) #4, was observed handling saline primed dialysate lines at Station #2 without gloves.
Observation #2: On 3/15/2021 at approximately 10:30 AM, PCT #4, was observed removing and discarding the CVC dressing at Station #3, then proceeding to clean the CVC access site without first removing gloves, performing hand hygiene, and donning clean gloves.
An interview with the facility nurse manager on 3/17/2021 at approximately 1:00 PM confirmed the above findings.
Plan of Correction:
3/26/21 By, the Clinical Manager (CM), will hold a staff meeting, elicit input, and reinforce the expectations and responsibilities of the facility staff on the following policies and CMS interpretive guidance.
- Version 1.1- V113 End Stage Renal Disease (ESRD) Program Interpretive Guidance
- Changing the Catheter Dressing
Any staff member not available for the meetings will be educated one on one as soon as they return to work.
Emphasis was placed on:
Because exposure to blood and potentially contaminated items can be routinely anticipated during hemodialysis, gloves are required whenever caring for a patient or touching the patient's equipment including but not limited to primed dialysis lines.
Gloves should be changed, and hand hygiene performed, when going from a "dirty" area or task to a "clean" area or task including but not limited to the removal of a central venous catheter dressing and before cleaning the site.
Effective 3/29/21, the CM or designee will conduct daily audits utilizing plan of correction (poc) audit tool for 2 weeks. Once compliance is sustained, the Governing Body will decrease frequency to weekly x 3 weeks then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinical Audit Tool.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly. The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings and
take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 4/9/21
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based upon observation, policy and procedure review, and an interview with the facility nurse manager, it was determined the facility failed to ensure the PCT (Patient Care Technician) to wash the vascular access area with liquid soap for patients unable to independently wash their access at the handwashing/clean sink, prior to initiating treatment for Observation #3 and Observation #4.
Findings include:
Review of policy "Access Assessment and Cannulation" on 3/17/2021 at approximately 12:15 PM states " Step 1: Prior to treatment, ask your patient to wash access area with liquid soap for one minute, rinsing well. Dry with clean paper towel. Wash access (per above) if patients unable to clean their access."
Observation #3: On 3/15/2021 at approximately 11:30 AM, PCT (Patient Care Technician) #4, was observed at Station #2, not washing the vascular access area for Patient #1(wheelchair bound) with liquid soap prior to initiating treatment.
Observation #4: On 3/15/2021 at approximately 12:00 PM, PCT #4, was observed at Station #3, not washing the vascular access area for Patient #2 (access located on thigh) with liquid soap prior to initiating treatment.
An interview with the facility nurse manager on 3/17/2021 at approximately 1:00 PM confirmed the above findings.
Plan of Correction:By 3/26/21, the CM will hold a staff meeting, elicit input, and reinforce the expectations and responsibilities of the facility staff on the Access Assessment and Cannulation Policy. Any staff member not available for the meetings will be educated one on one as soon as they return to work.
Emphasis was placed on:
Prior to treatment, ask your patient to wash access area with liquid soap for one minute, rinsing well. Dry with clean paper towel. If patient is unable to clean their access, the Direct Patient Care Staff (DPC) will clean the access (per above).
Effective 3/29/21, the CM or designee will conduct daily audits utilizing plan of correction (poc) audit tool for 2 weeks. Once compliance is sustained, the Governing Body will decrease frequency to weekly x 3 weeks then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinical Audit Tool.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly. The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues. The QAI Committee is responsible to provide oversight, review findings, and
take actions as appropriate. The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
Documentation of education, monitoring, QAI, and Governing Body is available for review.
The Clinic Manager is responsible for overall compliance. Completion Date: 4/9/21
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