Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 24, 2023 through October 26, 2023, Fresenius Medical Care Waynesboro, 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 October 24, 2023 through October 26, 2023, Fresenius Medical Care Waynesboro, 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 on review of policy/procedures, observations (OBS.) and an interview with the Agency Unit Manager and facility administrator, the facility failed to ensure staff performed handwashing/hand hygiene and wore gloves in four (4) out of fourteen (14) observations. (OBS # 1- # 4)
Review of Fresenius Kidney Care Clinical services hand hygiene on 10/26/23 at approximately 2:00 PM revealed: " Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination.; Responsibility: All staff, patients, patient care givers ....and any other indirect patient care staff must follow the same requirements for hand hygiene.; Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub ... ; Hands will be decontaminated using alcohol-based hand rub or by washing hands with soap and water when: Before performing any invasive procedure such as vascular access cannulation.., immediately after removing gloves, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with other objects within the patient station or treatment space ... "
Review of Fresenius Kidney Care Clinical services initiation and termination of treatment using a central venous catheter (CVC) on 10/26/23 at approximately 2:20 PM revealed: " Purpose: The purpose of this policy is to provide direction on initiating and terminating a hemodialysis treatment ...using a CVC " ; Background: The catheter exit site and hubs are the two (2) primary sources of microorganism access which can result in a blood stream infection (BSI). Strict infection control practices and adherence to the procedure is essential to prevent serious complications. " ; Infection control: Hand hygiene must be performed per policy: hand hygiene to prevent transmission of pathogenic microorganisms. Aseptic technique must be followed to prevent infection. "
Review of Fresenius Kidney Care Clinical services initiation and termination of treatment using an Arteriovenous (AV) graft or fistula on 10/26/23 at approximately 2:30 PM revealed: " Purpose: The purpose of this policy is to provide direction on initiating and terminating a hemodialysis treatment ...using an arteriovenous (AV) graft or fistula " ; Background: " A standardized method, ..., must be utilized when initiating or terminating dialysis treatments to minimize complications and ensure the safety of the patient. " ; Infection control: Hand hygiene must be performed per policy: hand hygiene to prevent transmission of pathogenic microorganisms. Aseptic technique must be followed to prevent infection. "
Floor observations conducted on 10/24/23 between 10:25 AM-12:00 PM and 10/26/23 between 10:00 AM-11:00 AM and 10/26/23 between 1:00 PM-1:30 PM revealed:
OBS # 1: Patient care technician (PCT) # 1 observed on 10/24/23 at 11:10 AM initiating treatment on patient located in station # 8 and no glove change or hand hygiene performed after touching dialysis machine to touching patient's belongings by taking blanket from patient bag and placing on patient.
OBS # 2: Patient care technician (PCT) # 1 observed on 10/24/23 at 11:20 AM initiating treatment on patient located in station # 2 and no glove change or hand hygiene performed after touching dialysis machine to touching patient's belongings by taking blanket from patient bag and placing on patient, taking patient's headphones from bag and handing the headphones to the patient.
OBS # 3: Patient care technician (PCT) # 2 observed on 10/26/23 at 11:10 AM initiating treatment on patient located in station # 3 and no glove change or hand hygiene performed after touching dialysis machine to touching patient's belongings by taking blanket from patient bag and placing on patient, taking patient's headphones from bag and handing the headphones to the patient and handing patient a bottle of soda from the patient bag.
OBS # 4: Registered Nurse # 1 observed on 10/26/23 at 11:20 AM initiating treatment on patient located in station # 5 and no glove change or hand hygiene performed after touching dialysis machine to touching patient's belongings by taking blanket from patient bag and placing on patient.
An interview conducted with the facility clinical manager and facility administrator on 10/26/23 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:To ensure compliance, the Clinic Manager (CM) or designee will re-educate all the direct patient care staff (DPC) staff on the following policy:
- Hand Hygiene
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
- Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyze
- Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyze
- Termination of Treatment Using an Arteriovenous Fistula or Graft and Optiflux® Single Use Ebeam Dialyzer
Special emphasis will be placed on ensuring that hand hygiene is always performed per policy to prevent possible cross contamination. The meeting will reinforce that hand hygiene must be completed after touching any inanimate objects, including the dialysis machine, patient belongings e.g. headphones, blankets, soda.
The in-servicing of staff will be completed by December 11, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for two (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 Quality Improvement 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.
494.60(a) STANDARD
PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY
Name - Component - 00
The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public.
Observations:
Based on observations and an interview with the facility unit manager and the facility administrator; the facility failed to maintain the integrity of the walls and the floors within the dialysis treatment area for ten (10) of fourteen (14) observations. OBS #5-# 14.
Findings include:
OBS # 5-11 completed 10/24/23 between 10:25 AM and 11:55 AM, multiple areas of backboards of walls behind the dialysis machines are chipped away at the base, loose wall moldings, water damage and two (2) panels of the wall are not secured to the wall between stations # 6 through # 8.
OBS # 12-completed 10/25/23 at approximately 2:30 PM, area of staff bathroom wall that connects to the dialysis treatment floor revealed paint chipping away at the base and water damage.
OBS # 13-completed 10/25/23 at approximately 2:40 PM, area in patient bathroom revealed water damages to tiles around toilet.
OBS # 14-completed 10/25/23 at approximately 2:45 PM, hole approximately a half inch by half inch in dirty sink by station # 3
An interview with the facility administrator on 10/25/23 at approximately 2:50 PM revealed: " We had a flood here awhile ago, a pipe burst upstairs in the pediatric office. We did make repairs then and they still have some repairs to do. Sure I can get you the work orders for it."
Email response received from facility administrator on 10/30/23 at 1:48 PM revealed: " Attached are the old POs and an updated PO to complete the work we spoke about. " Attachments revealed old work orders dated 10/7/22 and 10/26/22 for patching holes, fixing wall dings and painting the staff break room, patching holes in waiting room, installing two (2)touch pad door locks and Provide 2 crash bar key-pad locks with installation. The email also included an attachment dated 10/26/23 for the repairs to the treatment room floor that surveyor brought to the administrator ' s attention.
Surveyor sent email to facility administrator on 10/30/23 at 2:24 PM requesting facility checklists and policies for conducting physical plants checks and disinfection of the dialysis station and dialysis control unit and surveyor has not received any further response from facility administrator.
An interview conducted with the facility clinical manager and facility administrator on 10/26/23 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:On October 24, 2023, after the survey tour, the CM, the Director of Operations (DO), the Area Technical Operations Manager (ATOM) and the Biomedical Technician (BMT) met to review the physical plant issues identified in the unit. It was determined at the meeting an estimate would be obtained to have the repairs completed. The repairs include painting, repairing water damage and loose walls, patching holes and dings in the walls, touch pad door locks and crash bar key-pad locks. Once the estimate is obtained, it will be submitted to the DO for approval.
The DO will meet with the BMT, CM to review:
- Building Interior Physical Environment Inspection Audit
The meeting will focus on the importance of ensuring that the physical plant is always maintained in a clean and safe manner. The repair of any damage must be completed timely to provide a safe and comfortable environment.
In-servicing will be completed by December 11, 2023, and the training documentation will be on file at the facility.
After the completion of the repairs, the ATOM or designee will perform bi-monthly audits for three (3) months to ensure the facility is being maintained in a safe fashion. At that time if 100% compliance is maintained, the audits will then follow the monthly QAPI schedule. A POC specific auditing tool will be used for the audits.
Issues of non-compliance will be addressed by the DO with re-education and counseling.
The DO or designee will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
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 review of medical records (MR), policies and procedures and interviews with facility clinical manager and facility administrator, it was determined that the facility failed to adequately monitor blood pressures and pulses during treatment in two (2) of five (5) MR reviewed. (MR #3 and #4)
Findings:
Review of Fresenius Kidney Care Clinical services safety checks on 10/26/23 at approximately 2:00 PM revealed: " Purpose: The purpose of this policy is to provide guidance on safety checks to prevent, detect, and treat complications; Policy: Safety checks will be performed pretreatment and every thirty (30) minutes or more frequently as needed once the treatment has begun. "
Review of Fresenius Kidney Care Clinical services patient assessment and monitoring on 10/26/23 at approximately 2:10 PM revealed: " Pre-treatment assessment and data collection: Direct patient care staff may collect pre-treatment weight, blood pressure (BP), access, and complaints reported by the patient. Monitoring During Treatment: Obtain blood pressure and pulse rate every thirty (30) minutes or more as needed but not to exceed forty-five (45) minutes or per state regulations ... "
Review of medical records (MR) on 10/26/23 between 8:50 AM-10:15 AM, 12:10 PM-12:35 PM and 2:00 PM-2:35 PM revealed:
MR # 3: Start of care (SOC): 8/8/23; Review of treatment flow sheets from 10/12/23-10/24/23 revealed:
a.Treatment flow sheet from 10/21/23: Blood pressure: 183/101; pulse: 62 at 12:31 PM; next blood pressure and pulse check were completed at 2:02 PM and were Blood pressure: 167/94 and pulse: 67. (one (1) hour and one (1) minute between checks)
b.Treatment flow sheet from 10/24/23: Blood pressure: 125/65; pulse: 63 at 10:50 AM; next blood pressure and pulse check were completed at 12:12 PM and were Blood pressure: 128/71 and pulse: 64. (one (1) hour and two (2) minutes between checks)
MR # 4: SOC: 1/16/23; Review of treatment flow sheets from 10/12/23-10/24/23 revealed:
a.Treatment flow sheet from 10/11/23: Blood pressure: 103/62; pulse: 75 at 12:47 PM; next blood pressure and pulse check were completed at 1:39 PM and were Blood pressure: 115/60 and pulse:70. (fifty-two (52) minutes between checks)
b.Treatment flow sheet from 10/11/23: Blood pressure: 109/64; pulse: 78 at 2:33 PM; next blood pressure and pulse check were completed at 3:07 PM and were Blood pressure: 111/61 and pulse:79. (thirty-four (34) minutes between checks)
c.Treatment flow sheet from 10/16/23: Blood pressure: 120/71; pulse: 89 at 1:08 PM; next blood pressure and pulse check were completed at 2:11 PM and were Blood pressure: 136/83 and pulse: 84. (one (1) hour and three (3) minutes between checks)
d.Treatment flow sheet from 10/16/23: Blood pressure: 124/78; pulse: 79 at 2:28 PM; next blood pressure and pulse check were completed at 3:18 PM and were Blood pressure: 144/95 and pulse: 83. (fifty (50) minutes between checks)
e.Treatment flow sheet from 10/23/23: Blood pressure: 137/83; pulse: 86 at 12:47 PM; next blood pressure and pulse check were completed at 1:37 PM and were Blood pressure: 128/76 and pulse: 82. (fifty (50) minutes between checks)
f.Treatment flow sheet from 10/23/23: Blood pressure: 140/93; pulse: 93 at 2:03 PM; next blood pressure and pulse check were completed at 2:48 PM and were Blood pressure: 134/78 and pulse: 86. (forty-five (45) minutes between checks)
g.Treatment flow sheet from 10/25/23: Blood pressure: 131/72; pulse: 89 at 2:15 PM; next blood pressure and pulse check were completed at 3:12 PM and were Blood pressure: 129/68 and pulse: 75. (fifty-seven (57) minutes between checks)
An interview conducted with the facility clinical manager and facility administrator on 10/26/23 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:For ongoing compliance, the CM or designee will in-service all direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
The in-service will focus on ensuring that the patient's assessments and vital signs (VS) and safety checks are obtained per policy. The meeting will reinforce that the VS must be taken and documented during treatment every thirty (30) minutes but not to exceed forty-five (45) minutes.
In-servicing will be completed by December 11, 2023, and the training documentation will be on file at the facility.
The CM or designee will perform daily audits 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 maintained, the audits will then follow the monthly QAPI schedule. A POC specific auditing tool will be used for the audits.
Issues of non-compliance will be addressed by the CM with re-education and counseling.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
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