Initial Comments:
Based on the findings of an unannounced complaint survey conducted October 11,2023, Fresenius Medical Care - Dubois, 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 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on observations(OBS) tour, review of facility policy and procedure and interview with facility employees (EMP), the facility failed to maintain a sanitary environment for 1 (one) of 1 (one) observation. (OBS #1)
Findings include:
A review of facility policy conducted on 10/11/23 at approximately 1:30 pm " Priming an Optiflux Single Use E-Beam Dialyzer " Published: 05/02/2022 Reference Number: 45654 Version: 4 states: " ...Procedure ...1. Perform hand hygiene and don gloves. 2. Visually inspect the dialyzer for: Physical damage, Tampering with the dialyzer, Compromised packaging. Verify that the dialyzer blood ports are properly capped If no defects noted, place the dialyzer in the holder Venous end up. 3. Remove the 0.9% Normal Saline bag from its protective cover. Inspect the saline bag for: Leaks Port cover defects Expiration date If no defects noted, hang saline bag on the IV pole ...Note: Bloodlines and saline may not be removed from the outer wrapping and hung on the machine overnight. "
OBS#1 on 10/11/2023 at approximately 8:45 am: Surveyor observed approximately 8 (eight) - Optiflux dialyzers removed from packaging and 11 - one liter bags of 0.9% normal saline bags removed from manufacturers packaging placed directly on the common use counter next to hand washing sink.
On 10/11/2023 at approximately 08:55 am interview conducted with EMP#1 that confirms findings. EMP#1 states " I tell them all the time this is wrong. I will throw these all away and get new ones. "
Plan of Correction:V 111
For ongoing compliance, the Clinic Manager (CM) will in-service all direct patient care (DPC) staff on policy:
· Priming an Optiflux Single Use E-beam Dialyzer
The in-service will focus on the staff ensuring that no treatment supplies, including dialyzers and normal saline solutions (NSS), are removed from their outer protective wrapping prior to being used.
In-servicing will be completed by November 1, 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 Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (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.
Completion Date: December 8, 2023
494.30(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on observations (OBS) tour, review of facility policy and procedure and interview with facility employees (EMP), the facility did not ensure precautions were in place to maintain a clean environment to prevent the possibility of spreading infectious diseases for 2 (two) of 2 (two) observations. (OBS#1, OBS#2)
Findings include:
A review of facility policy conducted on 10/11/23 at approximately 12:00 pm " General Cleanliness and Infection Control Guidelines " Published: 02/07/2022 Reference Number: 47685 Version: 6 states: " Purpose - The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, aesthetically pleasant environment for patients, staffs, and visitors. Responsibility All staff Definitions Decontamination - The use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. "
OBS#1- conducted on 10/11/2023 at approximately 10:25 am: Surveyor witnessed staff personal coat, color black, placed on a wall hook with used " dirty " PPE is stored. Surveyor interview with EMP#1 at approximately 10:30 am confirms finding. EMP#1 states " I don ' t know why their coat is there. It is a dirty area for us to hang our gowns and shields that we wear for patient care. "
OBS#2- conducted on 10/11/2023 at approximately 11:30 am: Surveyor witnessed the same staff place the same personal coat, color black, on a wall hook with used " dirty " PPE is stored. Surveyor immediately verified observation with EMP#1. EMP#1 confirms finding. EMP#1 states " I can ' t believe they put their coat there again. I will have them remove it immediately. " At approximately 11:35 am surveyor witnessed EMP#6 take the personal coat from wall hook with used " dirty " PPE hanging on a wall hook next to the personal coat and then transport the personal coat to the employee break room and place it on the back of a chair.
10/11/2023 at approximately 12:40 am - an interview with EMP#1 confirmed above findings.
Plan of Correction:V 115
To ensure compliance the covering CM or designee will in-service all DPC staff on:
· General Cleanliness and Infection Control Guidelines
The in-service will focus on the staff ensuring that they take all steps necessary to prevent the possibility of spreading infections. Staff will be re-educated not to bring personal items onto the treatment floor. This includes clothing such as coats or jackets which must be stored in an area off the treatment floor.
Inservicing will be completed by November 1, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: December 8, 2023
494.30(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS
Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on observations (OBS), review of facility policy and procedure and interview with facility employees (EMP), the facility failed to ensure proper medication preparation and handling was performed for 1 (one) of 1 (one) observation. (OBS #1)
Findings include:
On 10/11/2023 at approximately 1:30 pm Review of policy and procedure " Medication Preparation and Administration " Published: 02/06/2023 Reference Number: 47488 Version: 9 states:
" ...Labeling Reconstituted Medication Solutions and Syringes
medications in syringes, not being administered immediately, shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time, and initials of the person who prepared the medication. If more than one syringe of the same medication is needed for a single patient, mark the label as " 1 of 2, 2 of 2. "
- Reconstituted medication admixtures shall also include on the label the date and time the solution was prepared.
syringes do not have to be labeled if drawn up and administered immediately. These unlabeled, filled syringes must not be placed down at any time. Only one unlabeled, filled syringe can be drawn up and administered at one time.
medications not being administered immediately must also be labeled as indicated above. "
" ...Pre-drawing Medications
may be pre-drawn up to 4 hours prior to administration (unless state specific requirements such as New Jersey, and New Mexico where there is a 1 hour maximum for pre drawing medications). These pre-drawn medications shall be labeled and must be kept under the preparer ' s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration. "
OBS #1 conducted on 10/11/2023 at approximately 9:00 am: Surveyor observed 15 prefilled syringes with preprinted labels affixed. The preprinted labels affixed to the syringes had patient name, patient medical record number, date of birth, medication name, strength of medication, date and amount of medication that was to be in the syringe. The labels on the syringes did NOT contain initials of the employee who prepared the syringes with medication. The syringes did NOT contain the time the medication was prepared. The syringes were observed lying on common counters in the center of the dialyis facility. The syringes were NOT in a controled or locked environment. Surveyor observed patients walking past the common counters to and from the treatment stations.
Interview conducted on 10/11/2023 at approximately 9:05 am with EMP#1 confirmed the above findings. EMP#1 states " Some of the staff feel that they can get the syringes ready whenever they want, we try to tell them not to and they don ' t listen. "
Plan of Correction:V 143
To ensure compliance the covering CM or designee will in-service all DPC staff on:
· Medication Preparation and Administration
The meeting will focus on the importance of the staff always adhering to all policies and ensuring that medications, including oral medications, are prepared and labeled with time, date and initials if not being administered immediately. This includes adding the initials and time to the pre-printed labels. The meeting will also reinforce that medications not administered right away must be stored in a secure and locked area and that medications may be pre-drawn up to four (4) hours prior to administration.
Inservicing will be completed by November 1, 2023. All training documentation is on file at the facility.
The covering 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 covering 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: December 8, 2023
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