Fmc Leah Layne Dialysis Center

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) 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. This Standard is not met as evidenced by: 28297 Based on observation, interview and policy review, the facility failed to ensure staff wore Personal Protective Equipment (PPE), appropriately for one of three days of the survey. The failure to wear PPE appropriately had the potential for staff to cross contaminate other surfaces and themselves and this could affect 38 in-center patients. Findings include: During an observation on 11/18/24 at 11:25 AM revealed Patient Care Technician (PCT) 4 was at Station 2 stripping the machine of contaminated dialyzer and lines. PCT 4 wore goggles on top of his/her head while stripping the machine. During an observation on 11/18/24 at 1:45 PM PCT 4 was at Station 2 cleaning the dialysis station using bleach wipes 1:100 concentration. PCT 4 goggles were on top of his/her head. During an observation on 11/18/24 2:15 PM PCT 4 was at Station 7 rinsing Patient (P) 9’s back via fistula (a surgical connection of the vein and artery to access during hemodialysis) and disconnected the venous and arterial lines from the needle access lines with his/her goggles on top of his/her head. During an interview on 11/18/24 at 2:25 PM PCT 4 confirmed she wore goggles on top of head during the above observations and did not realize that he/she did not have eye protection as required. During an interview on 11/20/24 at 1:00 PM the Clinic Manager confirmed staff were required to wear eye protection during any activity where there was a risk for splatter contamination of blood, body fluids or chemical contamination. Review of the facility policy “Personal Protective Equipment,” revised 11/06/23 revealed, “Personal protective equipment including a full-face shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potential infectious materials (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or splattering of blood might occur (e.g. during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood.) Review of the facility policy “Exposure Categories and Determination,” revised 07/01/24 revealed, “ ...Task and Procedures with Exposure Determination: Handling infected materials require gloves, Full Face shield or mask and goggle, and gown ...Termination of Hemodialysis-gloves, Full face shield or mask and goggles, and gown ...Cleaning the machine and patient area- gloves, full face shield or mask and goggles and gown ...””

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) 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]. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure two (Patients (P) 6 and P7) were protected from exposure to contaminates during initiation and discontinuation of Central Venous Catheter (CVC) (A hemodialysis central venous catheter is a type of access used for hemodialysis.) for two of three survey days. The failure to protect patients from contamination had the potential for increased risk of infection and this could affect 10 patients with CVC’s. Finding includes: 1.During an observation on 11/18/24 at 2:10 PM, Patient Care Technician (PCT) 1 was at Station 3 discontinuing the treatment via a CVC for P7. During the entire disconnection procedure, the patient mask was not covering the patient’s nose as required. During an interview on 11/18/24 at 2:20 PM PCT 1 confirmed the mask was not covering the patient’s nose as required to prevent contamination. 2.During an observation on 11/19/24 at 10:50 AM revealed PCT4 was at Station 3 initiating the treatment via a CVC and completed the CVC dressing change for P6. During the entire procedure, the patient mask was not covering the patient’s nose as required. During an interview on 11/19/24 at 11:00 AM PCT 4 confirmed the mask was not covering the patient’s nose as required to prevent contamination. During an interview on 11/20/24 at 1:00 PM the Clinic Manager confirmed the patients mask should be covering the patients nose during initiation and termination of the CVC to prevent potential contamination of the CVC per policy. Review of the facility policy “Central Venous Cather (CVC) Dressing Change,” revised 05/06/24 indicated, “ ... ...The patient and Inpatient Service Staff must wear a mask for all procedures that require accessing the catheter to help prevent contamination by airborne nasal bacterial ...””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 28297 Based on interview, personal file review, and policy review, the facility failed to ensure three of six personnel files reviewed had completed annual water training as required. (Patient Care Technician (PCT) 1, PCT3, and PCT4. The failure to have annual water training had the potential for staff not to be updated on any changes with the water testing procedure and this could affect 38 in-center patients. Findings include: Review of the personal file review form provided by the Administrator indicated that PCT1 had their last annual water skills validation on 06/06/23 (4 months 16 days late), PCT 3 had their last annual water skills validation on 08/06/21 (3 years, 3 months, and 14 days late, and PCT 4 had their last annual water skills validation on 12/10/21 (2 years, 11 month and 10 days late. During an interview on 11/20/24 at 1:00 PM the Clinic Manager confirmed the three PCT’s were late for their skills validation on water testing because their regular biomedical technician had been out on leave and there had been a change of management in the technical department. The Clinic Manager confirmed staff were required to complete annual competency on water training. During an interview on 11/20/24 at 1:00 PM the Area Technical Operations Director stated he was unaware that three PCT’s had not been up to date on their annual water competency. He/she stated they were sure there were more records for water competency check offs however he/she was currently unable to locate the check offs. Review of the facility policy “Knowledge, Skills and Competency Evaluation for Clinical Staff,” revised 06/04/24 indicated, “ ...Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given timeframe ...””

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 28297 Based on interview, record review, and review of facility policy, the facility failed to ensure two of five (Patients (P)2 and P3) were given the opportunity to attend and participate in their Plan of Care (POC). The failure to give patients opportunities to be involved in their POC had the potential for missed opportunities for improved care and this could affect 38 total facility patients. Findings include: 1.Review of the “Face Sheet” provided by the facility for P2 revealed the facility admitted the patient on 10/22/20 with a diagnosis of end stage renal disease (ESRD). Review of P2’s annual “POC” provided by the facility dated 09/20/24 revealed there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” 2. Review of the “Face Sheet” provided by the facility for P3 revealed the facility admitted the patient on 02/03/22 with a diagnosis of ESRD. Review of P3’s annual “POC” provided by the facility dated 06/14/24 revealed there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” During an interview on 11/20/24 at 12:50 PM the Registered Nurse (RN)1 stated the Clinic Manager was responsible for having patients sign their POC. During an interview on 11/20/24 at 1:00 PM the Clinic Manager stated he/she was responsible for having patients sign their POC however he/she acknowledged and confirmed P2 and P3 had not signed their POC. The Clinic Manager stated it was important for patients to sign to acknowledge the information in the POC. Review of the facility policy titled, Comprehensive Interdisciplinary Assessment and Plan of Care, revised 07/03/23 revealed, “ ...Patient Participation in Plan of Care the following are recommendations for involving the patient in the development and review of the Plan of Care: ...Encourage both patient and family to participate in the Plan of Care discussions in whatever format the facility and attending physician develop. Notify the patient inwriting of the time and date of the Plan of Care review ...If the patient and or designee is unable or unwilling to attend the Plan of Care meeting ...the Registered Nurse may review the Plan of Care as developed by the IDT at the meeting with the patient and obtain the patients’ signature and any comments. The patients’ level of participation is determined by the patients ...””