Fresenius Medical Care of Plymouth Cordage

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44223 Based on observation and staff interview, the facility failed to ensure that proper infection control practices were followed when personal protective equipment (PPE) came in contact with both clean and dirty areas on the dialysis treatment floor. Findings include: During an observation of the treatment floor on 3/25/25 at 11:00 A.M., the surveyor observed multiple hooks, along the wall, outside of the Clinic Manager’s (CM) office. There were 11 faceshields and 2 gowns hanging on the hooks. The faceshields were overlapping and stacked on each other, causing concern for potential cross contamination. The 2 gowns, which had been worn by staff on the treatment floor, were overlapping, causing concern for potential cross contamination. During an observation of the treatment floor on 3/26/25 at 7:45 A.M., the surveyor observed multiple hooks along the wall outside the CM’s office. There were 11 faceshields and 3 gowns observed hanging from the hooks. The shields and gowns were touching each other, causing concern for potential cross contamination. There was a stethoscope hanging on the hook, under one of the gown, causing concern for cross contamination. During an observation of the treatment floor outside of the isolation room on 3/26/25 at 2:00 P.M., the surveyor observed a stethoscope hanging on a hook and the end was touching the fire extinguisher located below the hook. During an interview on 3/26/25 at 2:00 P.M., the CM said that PPE should be separated when hung on the hooks. She said there is a special box, located by the exit door to the lobby where staff should store their stethoscopes.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 27189 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff (Registered Nurse [RN] #6), follow proper infection control practices during the initiation of dialysis for 1 of 2 patients (Patient #1) with an Arteriovenous Fistula/Graft (AVF/G), from a total sample of 8 patients. Findings include: Review of the facility policy titled, Assessment and Cannulation, dated 5/6/24, included but was not limited to the following: *Perform skin antisepsis on one site at a time, allow it to dry and then cannulate. Do not touch cannulation sites after skin disinfection. For Patient #1, RN #6 failed to disinfect the cannulation sites of the patient’s AVF/G, after she palpated the access sites, which increased the potential risk for infection. Patient #1 was admitted to the facility in January 2025 with the diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis three times a week. During an observation on the treatment floor on 3/25/2025 at 9:30 A.M., the surveyor observed RN #6 initiate dialysis treatment for Patient #1 with an AVF. RN #6 listened and palpated the fistula, then disinfected the upper and lower access of the AVF with two separate alcohol prep pads (one for each access site). RN #6 then palpated the access sites again, contaminating the site. Without performing disinfection of the access sites, RN #6 cannulated both sites. RN #6 failed to disinfect the access sites after she contaminated the area. During an interview on 3/25/25 at 9:45 A.M., RN #6 said she should have disinfected the AVF access sites after she palpated the area, just prior to cannulation.”

“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: 10249 Based on observation, staff interview, and policy review, the facility failed to ensure 1 of 2 staff observed (Registered Nurse [RN] #1) implemented adequate infection control measures during termination of treatment for 1 of 2 patients (#8) with a Central Venous Catheter (CVC), out of a total sample of 8 patients. Finding include: Review of the facility policy titled, Termination of Treatment Using a Central Venous Catheter and Optiflux single Use Ebeam Dialyzer, published 11/4/24, included the following: *Prior to termination: *Preparation: *Don own gown and full face shield with mask (or protective eyewear with full side shields and mask). Place mask on patient, perform hand hygiene, then don gloves. During an observation of the treatment floor on 3/25/25 at 9:30 A.M., the surveyor observed RN #1 terminate the dialysis treatment for Patient #8 who had a CVC for dialysis access. Patient #8 wore a mask below his/her nose, only covering his/her mouth, throughout the whole process of termination of dialysis treatment. RN #1 failed to encourage Patient #8 to adjust his/her face mask to cover his/her nose and mouth while she performed termination of dialysis treatment with CVC, including disconnecting the blood lines. During an interview on 3/25/25 at 9:35 A.M., RN #1 said she “totally missed that” and should have made sure that Patient #8’s mask was covering his/her nose and mouth. During an interview on 3/26/25 at 1:00 P.M., The Clinic Manager said the staff member had told her about the observation and the patient’s mask should have covered their nose and mouth during the termination of the treatment.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44223 Based on observation and staff interview, the facility failed to maintain a safe environment for staff in the water and storage supply room. Findings include: On 3/25/25 at 8:05 A.M., during the flash tour of the water and supply storage room, the surveyor observed the following: *The storage room floor was cement and gray in color. In five areas the floor was observed to have cracks and broken pieces. These cracks caused divots in the flooring causing potential risk for tripping. *In front of the storage room delivery door, the floor had two large circular broken areas, where the cement was missing, exposing the plywood underneath, causing potential risk for tripping. During an interview on 3/26/25 at 8:30 A.M., the Biomedical Technician (Biomed) said he has tried to patch the broken areas on the floor but it does not stay. He says he has to repatch the areas every three months or so. The Biomed said that the floor has been discussed in the past about what can be done to fix it but he is not really sure if there is a set plan in place to fix or replace the floor. During an interview on 3/26/25 at 2:30 P.M., the Director of Operations said he is aware of the floor in the water storage area, but had not developed a plan as to when the floor would be fixed.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 10249 Based on record review, interview, facility report review, and policy review, the facility failed to ensure an unstable comprehensive re-assessment and revision of the plan of care was conducted after an extended hospitalization stay greater than 15 days, for 1 of 7 applicable patients (#2), out of a total sample of 8 patients. Findings Include: Review of the facility policy titled, Comprehensive Interdisciplinary Assessment and Plan of Care, revised 7/3/23, indicated the following: *Unstable patients must be reassessed by the IDT (Interdisciplinary Team) monthly. Monthly reassessment and any POC updates related to the reason the patient is considered “unstable” must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the conditions is chronic. *The following are unstable criteria: *Extended or frequent hospitalizations: *a. Hospitalization of more that 15 days with discharge occurring within the last 30 days, or *b. More than 3 admissions in the past 30 days Patient #2 was admitted in November 2021 with a diagnosis of End Stage Renal Disease, requiring dialysis three times a week. Review of the clinical record indicated that Patient #2 had an annual Comprehensive Assessment completed in April 2024, with a plan of care developed based on that assessment. Further review of the clinical record, and Absence and Hospitalization report, indicated that Patient #2 had been hospitalized from 2/3/25 through 2/21/25, for a total of 18 days, for a diagnoses of osteomyelitis. During an interview on 3/26/25 at 9:40 A.M., the Clinic Manager said when Patient #2 returned to the clinic after the hospitalization, she discussed the status with the Medical Director who determined that the patient was stable, so the team did not reassess. She also said there is no documentation of the discussion she had with the Medical Director.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 10249 Based on review of the facility Quality Assessment Performance Improvement (QAPI) committee meeting minutes, review of the monthly infection control audits, interview, and policy review, the facility failed to ensure monthly visual infection control audits were completed for arteriovenous fistula and graft (AVF/AVG) disinfection compliance, to ensure they could be consistently measured, analyzed, and a plan developed based on the results of monthly infection control audits. Findings include: Review of the facility policy titled, Quality Assessment and Performance Improvement Program, dated 11/4/24, indicated the following: *The QAPI Committee will monitor data/information, prioritize areas for improvement, determine potential root cause analysis, develop, implement, evaluate and revise action plans that results in sustainable improvements in patients care. *Elements to be reviewed will include: -Patient care outcomes. -Infection surveillance. -Patient safety. -Staff training and education. *An effective and successful review of QAPI meeting and program activities will include: -Analysis of QAPI trending tool. -Review of the results of required self-audits. During the survey, 1 of 2 staff (Registered Nurse [RN] #6) observed had an infection control breach during initiation of hemodialysis treatment for a patient with an AVF. RN #6 failed to disinfect each access site after palpating with gloved hands, per facility policy. Review of the facility monthly visual infection control audit checklist for 12 months (March 2024 through February 2024) failed to include visual audits of care for patients with Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) access. During an interview on 3/26/25 at 1:00 P.M., the Clinic Manager said they do not monitor AVF/G during monthly infection control visual audits.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) 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; This Standard is not met as evidenced by: 27189 Based on record review, interview, and policy review, the Medical Director failed to ensure that staff followed the policy related to reversal of Central Venous Catheter (CVC) lines for 1 patient (#5), in a total sample of 8 patients. Findings include: Review of the facility policy titled, Reversal of Central Venous Catheter Lines, dated 2/5/2024, indicated but was not limited to the following: *The RN is responsible for assessing and performing any trouble-shooting procedures including reversal of CVC lines. *Reversal of CVC lines requires the following documentation in the patient’s medical recorded: *Provider order with frequency (each treatment, x 1, etc.) entered in the patient medical record. *Reason for line reversal. *Action of reversal in the treatment record. *Evaluation of catheter function and future need for vascular referral. For Patient #5, the staff failed to notify the physician of the CVC lines needing to be reversed, document the reason why, and obtain a physician’s order to reverse the lines, per facility policy. Patient #5 was admitted to the facility in March 2017 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Patient #5 was receiving dialysis treatment via a CVC. Review of the dialysis treatment flowsheets, dated 3/6/25 through 3/25/25, indicated that for 8 of 9 treatments the CVC lines were reversed on 3/6/2025, 3/11/2025, 3/13/2025, 3/15/2025, 3/18/2025, 3/20/2025, 3/22/2025, and 3/25/2025. Review of the clinical record, and dialysis treatment flowsheet, indicated there was no documented evidence that nursing had notified the physician and obtained an order to reverse the lines. During an interview on 3/26/25 at 3:00 P.M., the Clinic Manager (CM) said the nursing staff should notify the physician if the CVC lines needed to be reversed, document the reason why, and obtain a physician’s order to reverse the lines. She also said staff failed to do this.”