Davita Brunswick Dialysis

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 33921 Based on observation, staff interview, and a review of the Food and Drug Administration (FDA) recommendations and manufacturer’s Directions for Use (DFU), it was determined that the facility failed to ensure that expired medications in one of one Emergency Crash Cart, and in one of one Medication Refrigerator, were removed and not made available for use. This deficient practice had the potential to negatively affect the health and safety of 37 in-center hemodialysis (ICHD) patients, 29 Peritoneal Dialysis (PD) patients, and one Home Hemodialysis (HHD) patient, who were under the care of this facility. Findings include: During a tour of the facility with the Facility Administrator on 8/26/24 between 10:50 a.m and 11:30 a.m., the following medications had expired and some had no date of when these were opened/accessed, thus these were not suitable for use. In the Emergency Crash Cart: 1. one vial of Ondansetron Injection 4 mg/2 mL (for nausea and vomiting) - there was no date when it was opened/accessed and no initial of the person who opened/accessed it. 2. one vial of Diphenhydramine 50 mg/mL (antihistamine) - there was no date when it was opened/accessed and no initial of the person who opened/accessed it. In the In-Center Medication Refrigerator: 1. one opened/accessed multidose vial of Epogen 20,000 units (for the treatment of Anemia) - had no date when first accessed and no initial of the person who opened/accessed it. According to the manufacturer’s direction for use (DFU) - regarding storage of Epogen: - Throw away multiple-dose vials of Epogen no later than 21 days from the first day that you put a needle into the vial. Keep refrigerated. 2. one vial of accessed/opened Tubersol (Tuberculin Purified Protein Derivative, is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk), was dated (accessed) 4/2/24 with no initial of the person who opened/accessed it. According to the manufacturer’s DFU for Tubersol and FDA, opened/used Tubersol should be discarded after 30 days. 3. three vials of Flucelvax (influenza vaccine) and 10 prefilled syringes of Flucelvax, expired 6/2024. According to the manufacturer’s DFU regarding Flucelvax: - If the expiration date on the vial is just a month and a year (e.g., “08/23”), then the vaccine should not be used after the last day of August 2023. If the expiration day is a specific day (e.g., “8/15/23”), then the vaccine should not be used after that date. According to FDA recommendation dated 2/8/21, drugs’ expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective. A review of facility Policy: 1-06-01, titled, “Medication Policy” with latest revision date of October 2023, stated: 13. All open or unopened medication packages (i.e. vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired. 29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date... Each vial is labeled with the initials of the person opening the vial and the expiration date... ... Epogen multidose vials must be discarded 21 days after opening or accessed... 31. Medications are ordered and replaced prior to expiration...”

“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: 33921 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, a review of facility Procedures, and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse, (RN AA), observed during discontinuation of hemodialysis (HD) treatment on one of one Patient, (P), (P#8), and initiation of HD treatment on one of one patient, (P#9), who both had Central Venous Catheters (CVCs), utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques could negatively affect the health and safety of P#8 and P#9 and other patients who had CVCs, as their primary dialysis access. The facility had 37 in-center hemodialysis patients. Findings were: During observation in the Patient Treatment Room on 8/28/24 between 9:50 a.m. and 11:40 a.m., the following was revealed: - RN AA was observed during discontinuation of HD treatment on P#8 at Station (S), (S8). After disconnecting the used bloodlines (the arterial and venous ends of the extracorporeal circuit that connect the patient’s catheter to the dialyzer), from the CVC, RN AA did not disinfect the CVC hubs (the end of the CVC that connects to the blood lines or caps) before flushing the CVC limbs (the catheter that extends from the patient’s body to the hub) with Normal Saline flushes and Heplock (anticoagulant locking solution). RN AA only disinfected the CVC hubs prior to re-capping the hubs with new end caps, (cap - refers to a device that screws on to and occludes the hub). - RN AA was observed during initiation of P#9’s hemodialysis treatment at S16. RN AA did not remove used gloves and did not perform hand hygiene after removing P#9’s old CVC exit site dressing. Instead, RN AA proceeded to clean/disinfect P#9’s CVC exit site wearing the same contaminated gloves. - RN AA stated on 8/28/24 at 11:25 a.m., that he didn’t realize that he failed to change gloves and to perform hand hygiene after removing P#9’s old dressing. RN AA also added that he thought the CVC hubs (during termination of HD treatment), were only disinfected once right before covering the hubs with new end caps. - According to the CDC, cross contaminating (going from dirty to clean tasks), could cause the spread of bacteria/infections. And even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ... - According to CDC, BEFORE ACCESSING catheter hubs, needleless connectors or injection ports, vigorously apply mechanical friction or “scrub the hub” for no less than five seconds with an antiseptic... - CDC’s disconnection steps: b. Disconnect the bloodline from the catheter and disinfect the hub with a new antiseptic pad. Scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood)... A review of facility Procedure: 1-04-02B titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps” with latest revision date of 10/23, stated: 4. Remove old dressing and discard. 7. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. UPON COMPLETION OF DIALYSIS: 30. Clamp arterial catheter limb and blood line. Aseptically disconnect arterial blood line from arterial CVC limb. Attach a 10 mL (milliLiter, sic) syringe filled with normal saline to arterial catheter limb... 31. ... Aseptically disconnect venous blood line and connect 10 mL syringe with normal saline to the venous catheter limb... 32. If a CVC locking solution is prescribed, remove normal saline syringes and connect syringe appropriate for catheter lumen volume with prescribed locking solution to each catheter limb one at a time... 33. Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub... The facility’s Procedure at completion of dialysis for patients with CVC, did not show “scrub the hub” after disconnection of used blood lines and CVC limbs and/or before accessing catheter hubs.”

“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: 33921 Based on observation and staff interview, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was maintained free from damage and defects to ensure the safety of the patients and staff. This failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. This deficient practice was observed in one of one Dialysate Preparation Room. Findings were: - The pipe connector in the Granuflo Acid Mixer was covered with dust and a rust-colored substance. - The wooden door frame, of the back entrance and exit door, was partly coming off from the wall, and was not secured. - The drain area next to the Granuflo Acid Mixer was covered with whitish sediment. The Biomed Technician acknowledged these observations on 8/27/24 at 2:50 p.m. and stated that these will be addressed.”