Fkc Bridgeville

“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 appropriate Personal Protective Equipment (PPE) (refers to wearable equipment used to protect workers from serious injuries or illnesses while doing their jobs and acts as a barrier between infectious materials and the skin, mouth, nose, or eyes) as required during initiation of dialysis treatment via fistula/graft for one of three survey days. The failure to wear appropriate PPE has the potential for staff to be exposed to Bloodborne Pathogens (BBP) (infectious microorganisms in human blood that can cause disease in humans), which could affect 36 in-center. Findings include: Observation on 03/20/25 at 10:40 AM revealed Patient Care Technician (PCT) 1 was at Station 2 initiating the treatment for Patient (P)10 via the patient’s fistula (a connection between an artery and vein that allows access for hemodialysis). PCT1 had goggles and a mask. However, the mask was under the nose and barely over the mouth. During an interview on 03/20/25 at 10:50 AM, PCT1 acknowledged the mask was not covering their nose and was low on the mouth and that there was a risk for exposure to Bloodborne Pathogens if they were splattering from the fistula. During an interview on 03/21/25 at 1:25 PM, the Nurse Manager confirmed that staff should have a mask that completely covers the nose and mouth when goggles are worn to protect the staff from being splashed with blood and contamination. Review of the facility policy titled, “Personal Protective Equipment,” revised 11/06/23 indicated, “...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 potentially infectious material (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM 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).””

“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 review of facility policy, the facility failed to ensure staff completed Central Venous Catheter (CVC -a large flexible tube inserted into a vein in the arm, check, or neck that leads to the venal cava and can be used for hemodialysis) cleaning as required for one of two observations. The failure to complete CVC cleaning as required increased the risk for infections by contamination which could impact 12 patients with CVC’s. Findings include: Observation on 03/20/25 at 11:15 AM: Patient Care Technician (PCT) 2 was at Station 7, completing CVC care for Patient (P) 9. PCT2 removed the old dressing from the CVC, removed the gloves, and sanitized the hands. PCT2 then used a swab to clean the CVC site; however, PCT2 started at the top of the chest approximately 1-2 inches above the CVC insertion site, worked their way down to the insertion site, and cleaned around the insertion site. During an interview on 03/20/25 at 11:30 AM, PCT2 acknowledged they started at the top of the chest and worked their way down to the insertion site as that was how they were trained to complete CVC dressing change cleaning. During an interview on 03/21/25 at 1:25 PM, the Nurse Manager confirmed the cleaning of the CVC site should start at the insertion site and move away from the insertion site to prevent contamination of the CVC insertion site. A review of the facility policy titled “Changing the Catheter Dressing Procedure,” revised 02/05/24, indicated, “...Remove swab stick from package by stick and without touching foam applicator. Handle only the stick portion. Chlorhexidine and 70% alcohol: Using gentle back and forth friction. Clean the exit site continuing outward the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds. If exudate or crusting is noted, an additional swab stick may be necessary to clean the exit site ...””

“BICARB JUGS RINSED DAILY/STORED DRY CFR(s): 494.40(a) 6.5 Concentrate distribution: bicarb jugs rinsed daily/stored dry Bicarbonate concentrate jugs should be rinsed with treated water and stored inverted at the end of each treatment day. Pick-up tubes should also be rinsed with treated water and allowed to air dry at the end of each treatment day. This Standard is not met as evidenced by: 28297 Based on observation, interview, facility document review, and review of facility policy, the facility failed to ensure 13 of 13 bicarbonate jugs were stored inverted to ensure they air dry at the end of every day for one of three survey days. Five of 13 jugs were found with fluid in the bottom of the jugs for one of three survey days. The failure to ensure jugs were stored and allowed to dry has the potential for bacterial growth in the jugs, which could affect 36 in-center patients. Findings include: On 03/19/25 at 11:20 AM, an observation revealed that 13 bicarbonate jugs in the water room were not inverted on the storage shelf. Upon further inspection, five of the jugs were found to have fluid at the bottom. During an interview on 03/19/25 at 11:20 AM, Patient Care Technician (PCT)1 stated they did not know the jugs needed to be stored inverted to allow them to air dry. PCT1 confirmed there were five jugs with fluid in the bottom. During an interview on 03/21/25 at 1:25 PM, the Nurse Manager confirmed that Bicarbonate containers should always be stored inverted to ensure they air dry to prevent bacteria growth. A review of the “Bicarbonate Concentrate Container and Cap and Wand Rinse” document indicated that five jugs were rinsed on 03/18/25 by PCT1. Review of the facility’s policy and procedure titled, “Bicarbonate Concentrate Container Cap and Wand Disinfection Procedure,” revised 02/03/25 indicated, “ ...Invert concentrate container and cap to drain and allow to air dry ...Concentrate containers should be stored in a manner that prevents contamination and reduces environmental exposure to dust and debris’ ...””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 28297 Based on observation, interview, manufacturer directions for use, and review of facility policy, the facility failed to ensure residual chlorine strips were dated when opened as required for one of three observation days. The failure to date the strips caused the potential for strips to be used that may have expired, and this could affect 36 in-center patients. In addition, the facility failed to ensure staff emptied the prime fill prior to starting dialysis when using dialyzers per manufacturer’s directions for use for one of three observation days. The failure to dump the prime fill had the potential for patients to be exposed to endotoxin and or debris, and this could affect 36 in-center patients. Findings include: 1. An observation on 03/19/25 at 11:10 AM revealed a bottle of “Water Check RC, for Residual Chlorine in Rinse Water,” was sitting on the ledge between the bicarbonate mixing and storage tank that was opened and unlabeled. During an interview on 03/19/25 at 11:10 AM, Patient Care Technician (PCT)1 confirmed the bottle was open and unlabeled. However, it should have been labeled when opened, as it was only good for three months after opening. During an interview on 03/21/25 at 1:25 PM, the Nurse Manager confirmed it was expected that staff would date all bottles of strips when opened to ensure they were not expired. A review of the undated manufacturer’s directions for use for “Water Check RC, for Residual Chlorine in Rinse Water” indicated, “...Store the Watercheck RC Residual Chlorine Test Strip at room temperatures between 59’F and 86’F (15’-30’C). Do not expose the strip under direct sunlight. Do not refrigerate. Use the strip within three months after opening ...” A review of the facility policy titled “Testing for Residual Bleach Using Watercheck RC Residual Chlorine Reagent Test Strips,” revised 05/02/24, indicated, “ ...The opened bottle of strips will expire three months after the date the bottle is opened or on the manufacturer’s expiration date, whichever comes first.” 2. Observation on 03/19/25 at 11:35 AM: PCT1 initiated the treatment at Station 9 for Patient (P)7 via a Central Venous Catheter (CVC). PCT1 prepared the CVC and initiated the treatment, including connection; however, PCT1 failed to dump the prime fill as required. A review of P7 dialysis prescription, dated 03/17/25, revealed the patient used an Optiflux 180 non-reuse dialyzer. During an interview on 03/19/25 at 11:45 AM, PCT1 immediately admitted he/she failed to dump the prime fill as required to ensure the patient received fresh saline and not saline that had been recirculating. PCT1 stated there was a shortage of normal saline during COVID-19, and they were instructed not to dump the prime to save on saline. Observation on 03/19/25 at 12:00 PM: PCT3 initiated the treatment for P8 at Station 8. PCT3 failed to dump the prime fill saline just prior to initiating the treatment. A review of the dialysis prescription for P8, dated 03/12/25, revealed the patient used an Optiflux 160 non-reuse dialyzer. During an interview on 03/21/25 at 1:00 PM, Registered Nurse (RN)2 stated that during COVID-19, there was a shortage of normal saline intravenous fluid, and they were instructed not to dump the prime fill to save on normal saline. During an interview on 03/21/25 at 1:25 PM, the Nurse Manager stated that staff were required to dump the normal saline prime fill prior to initiating all treatment per facility policy. Review of the Directions for Use for “Optiflux 160, Optiflux 180, Optiflux 200 and Optiflux 250 Single Use Only Electronic Beam Sterilized,” revised 07/2023, found in the box as a package insert, indicated, “...Do not infuse the recirculated saline prime into the patient. Discard the recirculated saline and fill the entire extracorporeal circuit with fresh saline prior to connecting to the patient. The volume of fresh saline used to fill the extracorporeal circuit should be equal to the volume of the dialyzer and blood tubing set in use.” A review of the facility policy titled “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” revised 05/06/24, indicated, “...Follow the steps below to replace the fluid in the blood circuit with fresh saline using at least 300 milliliters. Replacement of fluid in the circuit is necessary to assure removal of any endotoxin from back filtration and/or residuals of the debris that may be present in a dry pack dialyzer from the manufacturing process.””

“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: 28297 Based on interview, medical record review, and review of facility policy, the facility failed to complete an unstable assessment for one of five sampled patients (Patient (P)2). The failure to complete an unstable assessment had the potential to miss opportunities for improvement, and this could affect 36 in-center patients. Findings include: A review of the medical record for P2 revealed the patient was admitted on 11/02/20 with a diagnosis including end-stage renal disease (ESRD). A review of the last Assessment and Plan of Care for P2 revealed the facility completed it on 04/22/24 and identified the patient as stable and ambulating with a cane. The patient was able to perform Activities of Daily Living independently. Review of the hospitalizations report provided by the facility revealed the patient was hospitalized from 01/08/25-01/11/25 with diagnosis of Cerebral Infarction, 01/21/25-01/23/25 with diagnosis Myocardial Infarction and hypotension, and 01/24/25-01/31/25 with diagnosis of Facial Weakness, Myopathy. In a review of the “Nurses Notes,” dated 01/13/25, the nurse documented that P2 had right-sided weakness, difficulty walking with a walker, and Aphasia (difficulty speaking). On 01/22/25, the nurse documented that the patient was transferred to a Rehab facility due to difficulty walking and speaking. A review of the “Provider Notes,” dated 02/17/25, for P2 revealed the physician (Medical Director) documented, “Recent admission for CVA (Cerebral Vascular Accident- Blood supply to the brain is reduced or blocked preventing the brain tissue from getting oxygen or nutrients). Then, another admission for NSTEMI [Non-ST Elevation Myocardial Infarction- Heart Attack- happens when the heart’s need for oxygen can’t be met] followed by rehab at [a local rehabilitation hospital]. Blood pressure 94/53”. During an interview on 03/21/25 at 9:05 AM, the Medical Director stated the Dietician, Nurse, and himself share oversight of the Assessment and Plan of Care process. The Medical Director confirmed that P2 was fragile and should have been made unstable due to multiple hospitalizations. He/she stated they did not realize the patient had been in the hospital that many times because his/her partner had seen the patient in the hospital. During an interview on 03/21/25 at 11:50 AM, the Dietician stated he/she oversees the schedule and invitations of the Plan of Care; however, the Doctor, Nurse Practitioner, and Nurse get together on patients who may be unstable to make that determination. During an interview with the Nurse Manager on 03/21/25 at 1:25 PM, he/she indicated the Dietician organizes the assessments and plans of care and talks to the Nurse Practitioner or Physician if there may be a patient who needs to be made unstable. The Nurse Manager confirmed P2 should have been made unstable in January and February 2025 due to a significant decline in status. Review of the facility policy “Comprehensive Assessment and Interdisciplinary Plan of Care,” revised 07/03/21, indicated, “ ...Unstable patients must be reassessed by the IDT 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 condition is chronic. The following are unstable criteria: Extended or Frequent hospitalizations: a. Hospitalization of more than 15 days with discharge occurring within the last 30 days, or b. More than 3 admissions in the last 30 days OR Marked deterioration in health status - IDT to identify and document the specific reasons, such as: a. Change in ambulation severe enough to interfere with the patient’s ability to follow aspects of the treatment plan. Hypotension, restlessness, pruritus or other symptoms severe enough to prevent completion of majority of dialysis ...””