Initial Comments:
Based on the findings of an onsite unannounced complaint investigation survey completed on January 3, 2024, Ara Dialysis Unit at Ohio Valley Hospital was found 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)(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 observations of the clinical area (OBS), a review of facility policy and procedure, and interviews with staff (EMP), the facility did not follow standard infection control precautions by implementing and maintaining policies and procedures for the cleaning and disinfection of contaminated surfaces in accordance with CDC guidelines for one (1) of two (2) observations (OBS) of Discontinuation of Dialysis and Post Dialysis Access Care of AV Grafts. (OBS1)
Findings include:
A review of CDC document Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019 notes, " 5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities ...n. For site decontamination of spills of blood or other potentially infectious materials (OPIM), implement the following procedures. ... Disinfect areas contaminated with blood spills using an EPA registered tuberculocidal agent, a registered germicide on the EPA Lists D and E (i.e., products with specific label claims for HIV or HBV or freshly diluted hypochlorite solution. ...1. * If sodium hypochlorite solutions are selected use a 1:100 dilution (e.g., 1:100 dilution of a 5.25-6.15% sodium hypochlorite provides 525-615 ppm available chlorine) to decontaminate nonporous surfaces after a small spill (e.g. <10 mL) of either blood or OPIM. If a spill involves large amounts (e.g., >10 mL) of blood or OPIM, or involves a culture spill in the laboratory, use a 1:10 dilution for the first application of hypochlorite solution before cleaning in order to reduce the risk of infection during the cleaning process in the event of a sharp injury. Follow this decontamination process with a terminal disinfection, using a 1:100 dilution of sodium hypochlorite. "
A review of facility policy, " G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area " on 12/27/23 at approximately 12:30 pm revealed: " 2. Bleach solutions for this purpose must be made fresh each day and all containers are labeled per Risk Management policies for labeling of chemical containers and must be covered with a lid to prevent contamination ... "
During an onsite observation of patient care on 12/27/23 at approximately 9:55 am a blood spill was observed during discontinuation of an AV graft. It was noted that the facility ' s containers of equipment cleaning solution were not labeled with a solution type and the spill was cleaned with wipes saturated in the cleaning solution. Multiple staff were questioned about the concentration and type of cleaning solution. EMP2 stated they were, " unsure " of the concentration of bleach. An interview was conducted with EMP6, clinic manager, at approximately 11:50 am and the findings of the unlabeled solution and blood spill were discussed. EMP6 confirmed per clinic policy disinfection of equipment was done with 1:100 bleach and there was no designation of a separate bleach concentration for blood spills.
The above finding was confirmed during an exit interview with EMP6, clinical manager, on 12/27/23 at approximately 4:00 pm.
Plan of Correction:V 000
The governing body and management staff of this facility takes this deficiency statement very seriously and will ensure that these citations are corrected and that they remain in compliance. The governing body met on 1/12/2024 to review and approve the plan of correction and the tools that will keep approved plan in compliance. The in-services and tools are attached and available for review in the facility.
V 122
An in-service was initiated to all Direct Patient Care (DPC) staff on 1/12/2024 by the Clinic Manager (CM) regarding the importance of preventing cross contamination by adhering to strict infection control practices when disinfecting the patient station and blood spills. Per G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area it states "1. Unless equipment manufacturers specify use of another agent, equipment, treatment area and work surfaces will be disinfected using a 1:100 bleach/water solution using 5.25% -6% bleach. 2. Bleach solutions for this purpose must be made fresh each day and all containers are labeled per Risk Management policies for labeling of chemical containers and must be covered with a lid to prevent contamination." Also, the policy was revised to state "1:10 bleach/water solution should be used for blood spills >10cc." It was stressed during the in-service that bleach solutions must be made fresh each day and the contents of the solution must be labeled on the container. A separate solution of 1:10 must also be made each treatment day and the container labeled with this concentration. The 1:10 bleach/water solution will be used for blood spills >10cc. This has been added to the monthly Infection Control (IC) Audit, which will be increased to weekly for 8 weeks by an assigned Direct Patient Care (DPC) staff member. Additionally, the CM will spot check the treatment floor, one day per week for 8 weeks, to ensure staff are labeling the bleach solution and using a 1:10 bleach/water solution for blood spills. All breaks in Infection Control will be immediately reported to and addressed by the Clinic Manager. The Clinic Manager will ensure compliance through direct observation and review of the Infection Control Audits at least monthly prior to the Total Quality Management (TQM) meeting. All findings will be addressed at the monthly TQM meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly audits or if trends are identified, disciplinary action.
494.30(a)(1)(i) STANDARD
IC-TRAINING & EDUCATION
Name - Component - 00
Infection Control Training and Education
Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices.
Observations:
Based on reviews of clinic's policies, personnel files (PF), and employee interviews (EMP), the clinic did not maintain documentation of completed staff education and training for one (1) of five (5) personnel files reviewed. (PF 4)
Findings include:
A review of facility policy, RM1000 Mandatory In-Services, on 1/27/23 at approximately 12:30 pm revealed, " Policy: ...Associates receive in-service training and education on critical safety and compliance programs affecting the associates ' and patients ' health and well-being. This will be done at the time of hire, annually, and whenever changes within the center require additional training. ...Guidelines: 1. Annual mandatory In-services include the following: Bloodborne Pathogen Regulations ...Medical Waste Management ...Safety Needle Training ...Hazard Communication Program ...Associate (Employee) Safety ...Fire and Emergency Evacuation Procedures ...Infection Control ...Medical Emergency Procedures ...Tuberculosis ...5. Mandatory in-services will be documented on the Training/Inservice Documentation Form and will be maintained for a period of three years from the date of training or as mandated by state regulations. Records of training and in-services will be maintained in the center ' s Training and In-service Binder."
A review of facility policy G19 Associates Training & In-Services on 1/27/23 at approximately 12:30 pm revealed, " Purpose: To ensure that ...associates: receive the training required to perform their assigned job tasks correctly and safely ...To ensure that all current ...associates: are trained on critical safety programs on a regular basis, and ...receive ongoing education on pertinent issues or procedures ...10. Ongoing education shall be made available to all employees through various methods ...11. The Center Manager is accountable for implementation of this policy, and will identify in-service needs, establish a plan to address the needs, and schedule required in-service sessions ... 13. Records of all in-services (mandatory and non-mandatory) will be maintained for a period of three years from the date of training or as mandated by State regulations if required longer. Records of in-services shall be maintained in the center ' s Record of In-service Manual ... "
During an onsite visit conducted on 12/27/23 personnel files were reviewed at approximately 3:00 pm for 2023 annual education and training. 2022 mandatory training and annual competencies were requested for PF4 at that time. Clinic manager was unable to locate the 2022 training for PF4. As of 1/3/2024 no documentation of PF4 ' s 2022 annual competency and mandatory training documentation was provided.
This finding was confirmed with EMP6, Clinical Manager, via email on 1/3/2024 at approximately 10:00 am.
Plan of Correction:V 132
An in-service was initiated to the Clinic Manager (CM) and Direct Patient Care (DPC) staff on 1/12/2024 by the Corporate Clinical and Regulatory Manager (CRM) regarding the policy for ensuring staff are trained on all mandatory training and competencies upon hire and annually. Per RM 1000 Mandatory Inservice policy "Innovative Renal Care and American Renal Associates' will ensure associates receive in-service training and education on critical safety and compliance programs affecting the associates'' and patients' health and well-being. This will be done at the time of hire, annually, and whenever changes within the center require additional training." It was stressed during the in-service that all staff are to complete all mandatory and annual competencies in the computerized system "UKG Learning" upon hire and then annually thereafter. All staff files have been audited to ensure annual in-services and competency are current. Staff #PF4 will complete all mandatory in-services and competency by 1/19/2024 and a record of this training is filed in the employee's personnel file record. The CM has documented the date of training on the Associate Monitoring Log that is used for tracking all staff in-services. The Associate Monitoring log is normally audit yearly and will now be completed quarterly for a minimum of 1 year to ensure all staff complete mandatory and competency upon hire and annually. New employees, upon hire, will be added to the Associate Monitoring Log and the CM will ensure all staff receive mandatory in-services and competencies upon hire and annually thereafter and that there is documentation in the employee personnel file supporting the training. The clinic manager will ensure compliance by reviewing the Associate Monitoring Log a minimum of quarterly, as outlined above, to ensure the training is completed. All findings from the employee file audits will be reviewed at the monthly Total Quality Management meeting, of which the medical director is a member, and where additional action will be taken as deemed appropriate by the committee such as continuing the quarterly audits and/or if trends are identified, disciplinary action.
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on observations of the clinical area (OBS), a review of facility policy and procedure, and interviews with staff (EMP) and patients (PT), the facility staff did not adhere to all policies and procedures relative to patient care, infection control, and safety for one (1) of two (2) observations (OBS) of AV fistula/Graft initiation. (OBS2)
Findings include:
A review of facility policy, " IC04A AVF-AVG Cannulation, Treatment Initiation and Termination ... " on 12/27/23 at approximately 12:30 revealed, " Actions ...1. The access will be washed with antibacterial soap and water or skin antiseptic wipe, prior to preparing the site for cannulation. ... Comments/Rationale ...Skin cleansing decreases the amount of bacteria present on the skin surface ... "
During an onsite observation of AV fistula/Graft initiations on 12/27/23 at approximately 11:00 am EMP1 removed a transparent, occlusive dressing from Patient 1 (PT1) ' s fistula site to reveal an area covered with an unknown cream. The site was wiped in a single stroke with a disposable towel prior to being prepped with antiseptic for cannulation. It was unable to be determined if the disposable towel contained soap and water or if the site was adequately cleansed prior to antisepsis.
During an onsite interview with PT3 at approximately 11:00 am on 12/27/23 it was noted that the ambulatory patient did not wash his graft site at the sink upon entry to the facility and he was " unsure " if a cleansing wipe was used by staff prior to the antiseptic wipe before cannulation.
The finding of OBS2 was reviewed with EMP6, clinical manager, during an exit interview at approximately 4:00 pm on 12/27/23.
Plan of Correction:V 715
The Corporate Clinical and Regulatory Manager (CRM) met with the Medical Director (MD) on 1/12/2024 to review the responsibilities of the position of medical director. Emphasis was placed on the responsibility of ensuring that all policies and procedures relative to patient admissions, patient care, infection control and safety are adhered to by all staff that treats patients in the facility including physicians, non-physician providers, registered nurses, and patient care technicians. A review/summary of the following in-services with staff was discussed:
An in-service was initiated with all Direct Patient Care (DPC) staff, including PT3 on 1/12/2024 by the Clinic Manager (CM) regarding the procedure for washing the patient vascular access prior to cannulation. Per procedure IC04A AVF-AVG Cannulation, Treatment Initiation and Termination "1. The access extremity will be washed with antibacterial soap and water or skin antiseptic wipe, prior to preparing the site for cannulation." It was stressed during the in-service to prevent the potential for vascular related infections, the patients' accesses must be washed with soap and water prior to cannulation. Prior to the DPC staff member initiating dialysis, they need to ask the patient if they have washed their access and educate the patient as to why it needs to be done prior to cannulation. This education is to be documented in the patient's medical record. If the patient is unable to wash their access, then the staff should assist the patient with washing their access. All patients were educated on 1/15/2024 regarding the requirement for washing their vascular access prior to cannulation.
These items are on the Infection Control (IC) Audit. The IC audit, normally completed monthly, will now be completed weekly for 8 weeks, by an assigned DPC staff member. The Clinic Manager will also spot check the treatment floor weekly for 8 weeks, to ensure patients are washing their dialysis access prior to cannulation and that staff are reminding patient. The Clinic Manager will ensure compliance through direct observation and through review of the Infection Control Audits. All findings will be addressed at the monthly Total Quality Management (TQM) Meeting, of which the Medical Director is a member, and additional action will be taken as deemed appropriate by the committee, such as more education, continuing the weekly audits or if trends are identified, disciplinary action.
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