Initial Comments:
Based on the findings of an on-site, unannounced Medicare recertification survey conducted April 10, 2023 through April 12, 2023, Rossmoyne Dialysis, 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 on-site, unannounced Medicare recertification survey conducted April 10, 2023 through April 12, 2023, Rossmoyne Dialysis, was found to have the following standard level deficiencies that were determined to be in substantial compliance with the 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 a review of facility policy/procedure, observations, and an interview with the facility adminstrator (EMP# 1), ), it was determined the facility failed to ensure the staff followed infection control protocols, including but not limited to, ensuring staff performed hand hygiene/don clean gloves according to facility procedure, for one (1) of two (2) observations of 'Discontinuation of Dialysis with Central Venous Catheter (CVC)' (Observation #1); and for eight (8) of eight (8) observations of patient treatment area (Observation #2-9).
Findings:
A review was conducted of facility policy on April 10, 2023 at approximately 1:00 p.m. Policy 'Infection Control for Dialysis Facilities: 1-05-01' states "...Teammate Hygiene....1. Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area...Teammate Safety...12. Gloves should be worn when:...Touching the blood lines, dialyzer or dialysis delivery system during or after a dialysis treatment..."
Observations conducted in the patient treatment area on April 10, 2023 between approximately 9:15 a.m. and 2:30 p.m. revealed the following:
Observation #1: On April 10, 2023 at approximately 1:51 p.m. while observing 'Discontinuation of Dialysis with Central Venous Catheter' observation #2, at station #4, employee #3 failed to remove gloves, perform hand hygiene and don clean gloves after reinfusing extracorporeal circuit and prior to closing CVC clamps and disinfecting CVC connections with appropriate antiseptic.
Observation #2: On April 10, 2023 at approximately 10:45 a.m. while observing the patient treatment area, employee #5 removed her gloves and donned clean gloves. Employee #5 failed to perform hand hygiene after removing dirty gloves and prior to donning clean gloves.
Observation #3: On April 10, 2023 at approximately 11:01 a.m. while observing the patient treatment area, employee #4 was at station #11, with patient #3 receiving his treatment. Employee #4 began to type on the dialysis machine keyboard and touch the dialysis machine screen without wearing any gloves.
Observation #4: On April 10, 2023 at approximately 11:20 a.m. while observing the patient treatment area, employee #5 removed her gloves and donned clean gloves. Employee #5 failed to perform hand hygiene after removing dirty gloves and prior to donning clean gloves.
Observation #5: On April 10, 2023 at approximately 11:29 a.m. while observing the patient treatment area, employee #5 was at station # 6, patient #9 was receiving his treatment. Employee #5 had gloves on while caring for patient #9, then went to station #7 which was vacant and began opening to outer packaging from clean tubing without changing gloves and performing hand hygiene.
Observation #6: On April 10, 2023 at approximately 11:55 a.m. while observing the patient treatment area, employee #5 removed her gloves and reached into the clean supply drawer. Employee #5 failed to perform hand hygiene after removing dirty gloves.
Observation #7: On April 10, 2023 at approximately 11:56 a.m. while observing the patient treatment area, employee #5 was at station #5, patient #5 was receiving his treatment. Employee #5 had gloves on while caring for patient #5, then picked up a black Sharpie marker from the nurse's station countertop, brought it to station #5, wrote on the tape that was on the dialysis chair tray, then returned the black Sharpie onto the clean nurses's station countertop. Employee #5 failed to removed gloves, perform hand hygiene prior to picking up the black Sharpie marker from the clean nurse's countertop.
Observation #8: On April 10, 2023 at approximately 12:07 p.m. while observing the patient treatment area, employee #5 was at station #5, patient #5 was receiving his treatment. Employee #5 walked away from the station, removed her gloves and took some alcohol wipes from the clean supply cart. Employee #5 failed to perform hand hygiene after removing dirty gloves.
Observation #9: On April 10, 2023 at approximately 2:19 p.m. while observing the patient treatment area, employee #5 removed her gloves and donned clean gloves. Employee #5 failed to perform hand hygiene after removing dirty gloves and prior to donning clean gloves.
An interview with the facility EMP# 1 on April 12, 2023 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:V 0113
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/03/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" rev. April 2023, with the emphasis on but not limited to: 1) All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves; c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact ... f. between patients even if the contact is casual; g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator will conduct infection control audits to verify glove wearing, glove changes and proper hand hygiene is performed by teammates per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT
Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility adminstrator (EMP# 1), it was determined the facility failed to ensure the staff disposed of, discarded, or dedicated items taken into the dialysis station for one (1) of eight (8) patient treatment area observations. (Obervations #7)
Findings:
A review was conducted of facility policy on April 10, 2023 at approximately 1:00 p.m. Policy 'Infection Control for Dialysis Facilities:1-05-01' states "...Dialysis Station Management...65. Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient or cleaned and disinfected fore taken to a common clean area or used on another patient..."
Observations conducted in the patient treatment area on April 10, 2023 between approximately 9:15 a.m. and 2:30 p.m. revealed the following:
Observation #7: On April 10, 2023 at approximately 11:56 a.m. while observing the patient treatment area, employee #5 was at station #5, patient #5 was receiving his treatment. Employee #5 had gloves on while caring for patient #5, then picked up a black Sharpie marker from the nurse's station countertop, brought it to station #5, wrote on the tape that was on the dialysis chair tray, then returned the black Sharpie marker onto the clean nurses's station countertop. Employee #5 failed to clean and disinfect the black Sharpie marker prior to returning it to the clean nurse's station.
An interview with the facility EMP# 1 on April 12, 2023 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:V 0116
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/03/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: 1) Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient.
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify non-disposable items are disinfected after each patient use, prior to removal from treatment area / station: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
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-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility adminstrator (EMP# 1), it was determined the facility failed to ensure staff followed standard infection control precautions by emptying the prime waste receptacle and disinfecting prior to preparing the machine/circuit for the next patient for three (3) of three (3) observations of 'Cleaning and Disinfection of the Dialysis Station' (Observation #1-3).
Findings:
A review was conducted of facility policy on April 10, 2023 at approximately 11:00 a.m. Policy 'Termination of Dialysis Utilizing Fresenius 2008 Series Dialysis Delivery System and Streamline Blood Lines:1-03-12F' states "... Procedure:...21. Once patient has vacated the dialysis station; empty and rinse priming container if needed. Clean exterior surface of dialysis system and the interior surface of reusable priming container with appropriate disinfectant...."
Observations conducted in the patient treatment area on April 10, 2023 between approximately 9:15 a.m. and 1:51 p.m. revealed the following:
Observation #1: On April 10, 2023 at approximately 9:34 a.m. while observing 'Cleaning and Disinfection of the Dialysis Station' observation #1, at station #11, employee #4 began to disinfect the front of the dialysis machine and the side of the dialysis machine. During the middle of cleaning the side of the dialysis machine, employee #4 emptied the prime waste receptacle, wiped the inside and outside of it out, put it back on the dialysis machine and continued wiping the side of the dialysis machine. Employee #4 failed to empty prime waste receptacle and clean the interior and exterior prior to cleaning and disinfecting the dialysis station.
Observation #2: On April 10, 2023 at approximately 10:00 a.m. while observing 'Cleaning and Disinfection of the Dialysis Station' observation #1, at station #5, employee #3 began to disinfect the front of the dialysis machine and the side of the dialysis machine. During the middle of cleaning the side of the dialysis machine, employee #4 emptied the prime waste receptacle, wiped the inside and outside of it out, put it back on the dialysis machine and continued wiping the side of the dialysis machine. Employee #3 failed to empty prime waste receptacle and clean the interior and exterior prior to cleaning and disinfecting the dialysis station.
Observation #3: On April 10, 2023 at approximately 10:26 a.m. while observing 'Cleaning and Disinfection of the Dialysis Station' observation #1, at station #7, employee #4 began to disinfect the front of the dialysis machine and the side of the dialysis machine. During the middle of cleaning the side of the dialysis machine, employee #4 emptied the prime waste receptacle, wiped the inside and outside of it out, put it back on the dialysis machine and continued wiping the side of the dialysis machine. Employee #4 failed to empty prime waste receptacle and clean the interior and exterior prior to cleaning and disinfecting the dialysis station.
An interview with the facility EMP# 1 on April 12, 2023 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:V 0147
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/03/23. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1) Verify patient's clothing is secured away from the exit site/work area. Rational: Securing the patient's clothing away from the work area minimizes the risk of cross contamination.
Verification of attendance is evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee will conduct audits to verify CVC exit site care complies with policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator will review audit results with the Medical Director during monthly Quality Assessment Performance Improvement Meeting known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for ongoing compliance with this plan of correction.
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 on a review of facility policy/procedure, observations, and an interview with the facility adminstrator (EMP# 1), it was determined the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for one (1) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' observations. (Observation #2)
Findings:
A review was conducted of facility policy on April 10, 2023 at approximately 10:00 a.m. Policy 'Central Venous Catheter (CVC) with clearguard HD Antimicrobial End Caps Procedure:1-04-02B' states "... Procedure:...3. Place patient in comfortable supine position. Verify patient's clothing is secured away from the exit site/work area....Rationale...3...Securing the patient's clothing away from the work area minimizes the risk of cross-contamination..."
Observations conducted in the patient treatment area on April 10, 2023 between approximately 9:15 a.m. and 1:51 p.m. revealed the following:
Observation #2: On April 10, 2023 at approximately 11:05 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #2, for patient #3, station #11 employee #4 failed to ensure the patients shirt was secured away from the exit site. The patients shirt made contact with the access site after the CVC exit site area was cleansed with antiseptic. Employee #4 failed to cleanse the area again after the patient's shirt made contact with the access site and prior to applying a sterile dressing to the CVC exit site.
An interview with the facility EMP# 1 on April 12, 2023 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/03/23. Surveyor observations were reviewed. Education included but was not limited to a review of Procedure 1-04-02B "Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure" with emphasis on but not limited to: 1) Verify patient's clothing is secured away from the exit site/work area. Rational: Securing the patient's clothing away from the work area minimizes the risk of cross contamination.
Verification of attendance is evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee will conduct audits to verify CVC exit site care complies with policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator will review audit results with the Medical Director during monthly Quality Assessment Performance Improvement Meeting known as Facility Health Meeting, with supporting documentation in the meeting minutes. The Facility Administrator is responsible for ongoing compliance with this plan of correction.
**Please Note: Observation #: 0122 should have had the following POC instead of the POC for V0147:
V 0122
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 05/03/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with the emphasis on but not limited to: 1) At the end of each treatment, the dialysis station will be cleaned and disinfected... Priming containers are to be emptied prior to disinfection.
Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify priming containers are emptied at the end of treatment, prior to disinfection: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meetings, with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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