Initial Comments:
Based on the findings of an on-site, unannounced Medicare recertification survey and complaint investigation survey conducted April 19, 2022 through April 21, 2022, US Renal Care Carlisle 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 and complaint investigation survey conducted April 19, 2022 through April 21, 2022, US Renal Care Carlisle Dialysis, 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 facility policies/procedures, observations of the patient treatment area during patient care and interview with facility administrator (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 three (3) of three (3) patient treatment area observations (OBS). (OBS #3, OBS #4 and OBS #5); and one (1) of two (2) of 'Access of AV Fistula or Graft for Initiation of Dialysis' observations. (OBS #6)
Findings Included:
Review of 'Hand Hygiene: Policy: C-IC-0060' policy/procedure on April 20, 2022 at approximately 1:45 p.m. revealed, "...HAND HYGIENE will be performed....14...After handling biohazardous waste...
Review of 'Assessment and Needle Placement for Existing and New AV Fistula and Graft: Policy: C-TI-0030' policy/procedure on April 20, 2022 at approximately 12:15 p.m. revealed, "...PROCEDURE: 1. Don full PPE, perform handy hygiene and don clean gloves. a. Patient must wash access with soap and water prior to disinfection and cannulation. b. If unable, staff will wash patient's access with soap and water (rinsing and drying afterwards), other approved skin cleansing agent or cleansing wipe...2. Access Assessment...3. Access preparation...b. Locate and palpate the needle cannulation sites prior to skin disinfection; remove gloves, perform hand hygiene and don clean gloves. c. Disinfect each access site separately with one of the below options..."
Patient treatment area observations conducted on April 20, 2022 between approximately 9:04 a.m. and 11:38 a.m. revealed the following:
OBS #3: On April 20, 2022 at approximately 10:13 a.m. surveyor observed employee #7, remove dirty gloves, walk to cabinet containing empty, unused lab tubes and remove one (1) empty lab tube from the cabinet. Employee #7 failed to perform hand hygiene after removing dirty gloves.
OBS #4: On April 20, 2022 at approximately 10:18 a.m. surveyor observed employee #7, throw away one (1) blood filled lab tube, remove her dirty gloves and don clean gloves. Employee #7 failed to perform hand hygiene after removing dirty gloves and prior to donning clean gloves.
OBS #5: On April 20, 2022 at approximately 11:12 a.m. surveyor observed employee #7, carrying two (2) blood filled lab tubes, placing them in the blood tube rack and then put on clean gloves. Employee #7 failed to perform hand hygiene after carrying blood filled lab tubes and prior to donning clean gloves.
OBS #6: 'Access of AV Fistula or Graft for Initiation of Dialysis' On April 20, 2022 at approximately 10:05 a.m. surveyor observed employee #7, wash skin over access with soap or antibacterial scrub, evaluate access; locate/palpate cannulation sites and then apply antiseptic to skin over cannulation sites to patient # 9 at station #8. Employee #7 failed to remove gloves, perform hand hygiene and don clean gloves after evaluating access and prior to applying antiseptic to skin over cannulation sites.
An interview with the facility administrator on April 21, 2022 at approximately 2:00 p.m. confirmed the above findings and confirmed the above policy as current.
Plan of Correction:Staff educated regarding policy C-IC-0060: Hand Hygiene and policy C-TI-0030: Assessment and Needle Placement for an Existing and New AVF/AVG. Education reinforced the following infection control and hand hygiene requirements: hand hygiene must be performed after every glove removal; hand hygiene must be performed following contact with biohazardous waste; glove change and hand hygiene must be performed following access assessment and prior to applying antiseptic to the skin over cannulation sites. FA or designee will audit for proper glove change and hand hygiene compliance 2 times per week for 3 weeks and then monthly x 3. The results of the audits will be reviewed with the staff weekly upon initial auditing and then monthly as audits are completed. Audit results will be reviewed during monthly QAPI meetings. The Governing Body will review QAPI meeting minutes to ensure continued compliance. Identified non-compliance will result in additional staff in-servicing and increased frequency of auditing.
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 review of facility policy/procedure, observations of the patient treatment area during patient care and interview with facility administrator (EMP# 1), it was determiend the facility failed to ensure patients wore face masks to protect themselves for one (1) of one (1) of 'Initiation of Dialysis with Central Venous Catheter (CVC)' observations (OBS). (OBS #2)
Findings Included:
Review of 'Accessing and De-Accessing the Dialysis Catheter: Policy: C-TI-0090' policy/procedure on April 20, 2022 at approximately 12:00 p.m. revealed, "...PROCEDURE: 1. Don full PPE including mask; assist patient to don mask..."
Patient treatment area observations conducted on April 20, 2022 between approximately 9:04 a.m. and 11:38 a.m. revealed the following:
OBS #2: 'Initiation of Dialysis with Central Venous Catheter' On April 20, 2022 at approximately 10:30 a.m. surveyor observed employee #7 initiate dialysis with a central venous catheter for patient #7 at station #11. Patient #7's face mask was positioned below the nose during the entire CVC dialysis initiation. Employee #7 failed to ensure employee #7's face mask was positioned correctly.
An interview with the facility administrator on April 21, 2022 at approximately 2:00 p.m. confirmed the above findings and confirmed the above policy as current.
Plan of Correction:Staff educated regarding policy C-TI-0090: Accessing and De-accessing the Dialysis Catheter. Education reinforced that the mask must cover the nose and mouth of the patient and staff member when accessing the CVC, performing a CVC dressing change, and de-accessing the CVC. FA or designee will audit for proper mask placement during CVC care 2 times per week for 3 weeks and then monthly x 3. The results of the audits will be reviewed with the staff weekly upon initial auditing and then monthly as audits are completed. Audit results will be reviewed during monthly QAPI meetings. The Governing Body will review QAPI meeting minutes to ensure continued compliance. Identified non-compliance will result in additional staff in-servicing and increased frequency of auditing.
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 review of facility policy/procedure, flash tour observation of the patient treatment area during patient care and interview with facility administrator (EMP# 1), it was determiend the facility failed to ensure that correct cleaning and disinfection of environmental surfaces was performed for one (1) of one (1) observations (OBS). (OBS #1)
Findings Included:
Review of 'Guidelines for the Handling and Disposal of Infectious Medical Waste: Policy: C-IC-0100' policy/procedure on April 19, 2022 at approximately 9:35 a.m. revealed, "...BACKGROUND...3. the following are to be considered and treated as infectious and/or special waste materials...PROCEDURE:...10. Spills from hazardous waste containers will be cleaned up immediately using a two-step process. a. Clean the gross spill with a 1:100 bleach solution for a 5-minute minimum contact time or other facility-approved disinfectant with equivalent germicidal properties. b. Reapply 1:100 bleach solution for a 5-minute contact time..."
Flash tour patient treatment area observation conducted on April 19, 2022 between approximately 9:30 a.m. and 10:00 a.m. revealed the following:
OBS #1: On April 19, 2022 at approximately 9:35 a.m. surveyor observed employee #7 clean-up drops of blood from the floor. The area was not cleaned a second time with a new disposable towel.
An interview with the facility administrator on April 21, 2022 at approximately 2:00 p.m. confirmed the above findings and confirmed the above policy as current.
Plan of Correction:Staff educated regarding policy C-IC-0100: Guidelines for the Handling and Disposal of Infectious Medical Waste. Education reinforced that a 2-step process must be utilized when cleaning blood from a surface. Staff are to clean the blood with a 1:100 bleach solution-soaked cloth and follow with a second cleaning with a new 1:100 bleach solution-soaked cloth. FA or designee to audit for proper cleaning of visible blood 2 times per week for 3 weeks and then monthly x 3. The results of the audits will be reviewed with the staff weekly upon initial auditing and then monthly as audits are completed. Audit results will be reviewed during monthly QAPI meetings. The Governing Body will review QAPI meeting minutes to ensure continued compliance. Identified non-compliance will result in additional staff in-servicing and increased frequency of auditing.
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