Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 2,2023 through October 5, 2023, Fresenius Medical Care Dubois, Llc., 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 2,2023 through October 5, 2023, Fresenius Medical Care Dubois, was identified to have the following standard level deficiency, and was 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 observation of the clinical area, facility policy and an interview with the facility administrator, clinic manager and facility nursing staff, the facility did not ensure infection control procedure regarding glove removal and handwashing for one (1) of 2 (two)observations (OBS#1).
Findings include:
Review of policy: Personal Protective Equipment; reference number: 47663 revealed...
"...A supply of clean, non-sterile gloves and a waste container shall be placed
near each dialysis station or treatment area.
Disposable gloves must be used:
When holding access bleeding sites.
When performing venipunctures or other vascular access
procedures
When handling blood specimens.
When handling contaminated dialysis equipment and accessories.
When touching blood, body fluids, secretions, excretions, or items
or surfaces potentially contaminated with these substances.
When touching patients during activities with potential exposure
to bloodborne pathogens and other potentially infectious material.
When injecting solutions or medications.
When touching any part of the dialysis machine or equipment at
the dialysis station.
Gloves must be worn appropriately.
Change gloves and practice hand hygiene between each patient and/or station
to prevent cross-contamination.
Remove gloves and wash hands after each patient contact, and after exposure
to blood and body fluids. If hands are not visibly soiled, use of a waterless
antiseptic hand rub is acceptable. (See Hand Hygiene policy).
Hand hygiene must always be performed after glove removal..."
Observation of the clinical area was conducted on 10/2/23 at approximately 2:00 p.m. to 3:30 p.m.
OBS#1 Station # 2 after termination of dialysis procedure patient donned glove to right hand to hold/apply pressure to cannulation sites post treatment to stop bleeding, removed glove, packed personal belongings, walked to scale, touched buttons on scale to obtain weight, walked to exit door from facility, opened door with right hand, no hand hygiene was performed by patient between termination of treatment and exiting of facility.
Interview at approximately 3:50 p.m. with charge nurse confirmed patient did not perform hand hygiene. Charge nursee states "We encourage them to, but they don't always listen and we can't force them to do it."
Plan of Correction:V 113
To ensure compliance the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on:
- Hand Hygiene
- Personal Protective Equipment
The meeting will focus on ensuring that hand hygiene is always performed by patients after removing the glove used to hold their access site. Staff will be informed to remind the patient to complete hand hygiene and to offer the hand gel to the patients before they exit the station.
All patients will be re-educated on the importance of hand hygiene, especially after glove removal. The patient education will be completed by October 31, 2023, with a note completed in the patients' medical record regarding the re-education.
Inservicing for the DPC staff will be completed by October 24, 2023. All training documentation is on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) specific 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: November 24, 2023
494.30(a)(4)(i) STANDARD
IC-HANDLING INFECTIOUS WASTE
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-
(i) Handling, storage and disposal of potentially infectious waste;
Observations:
Based on observations and interview with Clinic Manager and Administrator the clinic failed to ensure staff transported infectious waste to a closed bin for one (6) of six (6) observations.
Findings include:
Observation #1 10/3/23 at approximately 10:45 am EMP#8 was observed removing used blood line/extracorporeal system from station # 10, held the system in gloved hands approximately 6 (six) to 12 inches from EMP#8 body and proceeded to walk approximately 8 (eight) feet to biohazard container sitting with it's lid open containing contaminated waste products to discard used system. EMP#8 walked past a designated clean sink and a clean utility cart that contained clean supplies. The system was observed leaving a spotted trail of blood droplets falling to the floor in front of EMP#8 walking path. EMP#4 stated "I did not notice the lines leaking onto the floor." Surveyor showed EMP#8 where droplets had left a trail. EMP#8 stated "I will clean that up now."
Observations #2, #3, #4, #5, #6 on 10/3/23 from approximately 11:00 am to 1:45 pm revealed EMP#8, EMP#10, EMP#9 and EMP#5 continued to transport used blood lines/extracorporeal systems from stations # 4, #5 and #9 to a biohazardous waste container with a lid that remained open for the entire observation period stated.
Observations reviewed with EMP#5, EMP#8, EMP#9 and EMP#10. EMP#5 stated "I didn't realize the lid had to be closed while we were treating patients if it stays in the designated dirty area."
An interview with EMP#2 (clinic manager) and EMP#1 (area operations director - AOD) on 10/3/23 at approximately 3:00 PM confirmed the above findings . EMP #2 states "we can correct that."
Plan of Correction:V 121
To ensure compliance the CM or designee will in-service all the DPC staff on:
- General Cleanliness and Infection Control Guidelines
The in-service will focus on ensuring that all bio-hazard containers are easily accessible and located as close as is feasible to the immediate area for disposable of the contaminated supplies. Staff will be instructed to bring the bio-hazard container close to the patient station and not to walk across the treatment floor with used bloodlines. The staff will also be reminded that the lids to the bio-hazard containers must be kept closed whenever they are not in use and that any blood splatters must be cleaned up right away.
Inservicing will be completed by October 24, 2023. All training documentation is 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/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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: November 24, 2023
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 upon a review of facility policy, review of manufacturer's direction for use, treatment area observations, and an interview with the Charge Nurse, Clinic Manager and Facility Administrator, facility failed to ensure staff maintained aseptic technique for the care of vascular accesses, including intravascular catheters, for two (2) of two (2) observations (Observation #1, Observation #2).
Findings include:
On 10/3/23 at approximately 12:15 p.m. a review of Manufacturer's direction for use - Chloraprep One-Step (2% Chlorahexidine gluconate/ 70% Isopropyl alcohol) antiseptic swab states"...dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds..."
On 10/3/23 at approximately 1:00 p.m. a review of policy reference number: 45664 states Action: Step 2 "...2% Chlorahexidine and 70% Alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle..."
Observations conducted in patient treatment area on 10/3/23 between approximately 10:45 a.m.-12:00 p.m. and 10/4/23 between approximately 11:00 a.m.-12:00 p.m. revealed the following:
Observation #1: During observation (1 of 2) of Central Venous Catheter (CVC) Exit Site Care on 10/3/23 at approximately 11:00 a.m., station #9, Employee #9; Employee #9 cleansed area around the CVC exit site, starting from the insertion site and moving outward in a spiral circular motion with a Chloraprep One-Step (Chlorahexidine swabstick) antiseptic swab.
An interview with Charge Nurse, Clinic Manager and Facility Administrator on October 3, 2023 at approximately 3:00 p.m. confirmed the above findings. Charge Nurse states "The procedure is a circular motion from inside, closest entry point, to outside away from the catheter making a spiral."
Observation #2: During observation (2 of 2) of Initiation of Dialysis with Central Venous Catheter on October 4, 2023 at approximately 11:15 a.m., station #1, Employee #11; Employee #11 set up "clean field" with supplies to use for initiation placed on barrier sheet, clean supplies include: 6 (six) alcohol antiseptic wipes and (6) six 10cc syringes. Employee #11 disinfected the patients CVC hubs with antiseptic wipes, placed used "dirty" antiseptic wipes on clean barrier with clean supplies. Employee#11 immediately proceeded to attach the 10 cc syringes (one at a time) to the CVC hubs - withdrawing blood from the CVC hubs. Employee#11 then detached the used 10 cc syringes (one at a time) - filled with blood - and placed them onto the clean field with remaining clean supplies. Employee#11 immediately proceeded to attach the next 10 cc syringe filled with heparin medication and instill the heparin directly into the CVC hub, removed that 10cc syringe and placed it onto clean field. Employee #11 then immediately connected the remaining 2 (two) pre-filled normal saline syringes to the CVC hubs (one at a time) and instilled the normal saline solution. Employee #11 performed cleansing with antiseptic wipes at the beginning of the afformentioned interaction with the CVC. CVC hubs were not disinfected again prior to attaching sterile syringes to each port.
An interview with employee #11 on 10/4/23 at approximately 11:30 a.m. confirmed the above findings. Employee #11 states "I usually just throw everything away immediately. I can't believe I did that.". An interview with clinic manager and facility administrator on 10/4/23 at approximately 1:30 p.m. confirmed the above findings. Clinic manager states "Employee #11 had told me what happened and knows better.".
Plan of Correction:V 147
To ensure compliance the CM or designee will in-service all DPC staff on the following policies and procedure:
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
The meeting will emphasize that all staff must ensure that strict infection control practices per policy are adhered to when caring for a patient with a CVC. The meeting will reinforce that the patient's central venous catheter (CVC) site is cleaned starting in the center and moving outward for 2 inches in a concentric circle. The in-service will also review that no dirty items, such as used antiseptic wipes, may not be placed on the exit site clean barrier. The meeting will reinforce that the CVC hubs are disinfected prior to attaching saline syringes to each port.
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/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific 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: November 24, 2023
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