Davita Littleton Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.30 Infection Control, was out of compliance. V117 - 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. Based on observations and interviews, the facility failed to properly store and secure medications in one of one observations of medications left on a countertop located in front of the dialysis stations, in the dialysis treatment area. V146 - The facility must demonstrate that it follows standard infection control precautions by implementing-] (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.” Based on observations, interviews, and document review, the facility failed to ensure patient care staff performed hand hygiene when a central venous catheter (CVC, a device inserted through the skin for direct access to a large vein in the patient for dialysis treatment) was accessed according to facility policy in one of two observations of staff accessing CVCs. Additionally, the facility failed to ensure patient care staff allowed dry time after the hub of the CVC catheter was cleaned in four of four observations of staff cleaning CVCs.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.60 Physical environment, was out of compliance. V401 - Physical environment. The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. Based on observations, interviews, and document review, the facility failed to have a process in place to ensure expired medications and medical supplies were removed and not available for use in one of one medication storage areas. V403 - Standard: Equipment maintenance. 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. Based on observations, document review, and staff interviews, the facility failed to maintain the storage of peracetic acid (a highly corrosive liquid used as an antimicrobial agent and sanitizer) at the temperature instructed by the manufacturer and facility policies in one of one storage areas observed which contained this acid.”

“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: 45020 Based on observations and interviews, the facility failed to properly store and secure medications in one of one observations of medications left on a countertop located in front of the dialysis stations in the dialysis treatment area. Findings include: Facility policies: The Infection Control for Dialysis Centers Policy read, the purpose of this policy is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. The Medication Policy read, non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 1. The facility failed to ensure heparin (a medication that stops blood from forming blood clots) was properly stored and secured in the patient treatment area. A. Observations i. On 7/31/24 at 10:05 a.m., observations were conducted in the treatment area. On a countertop located in front of the dialysis stations, six syringes were filled with heparin and labeled with the patients’ names and the doses in the syringes. No staff was observed directly supervising the medication. B. Interviews i. On 7/31/24 at 10:22 a.m., an interview was conducted with patient care technician (PCT) #9. PCT #9 stated the syringes contained heparin. PCT #9 stated the countertop where they were observed was not a medication storage area. ii. On 7/31/24 at 10:31 a.m., an interview was conducted with PCT #2. PCT #2 stated the heparin syringes were prepared for patients who had not yet arrived for treatment. PCT #2 stated syringes that contained heparin were not normally stored on this countertop. PCT #2 stated there was a risk of contamination if the syringes fell off the countertop or if a patient accessed the syringes. iii. On 8/1/24 at 12:58 a.m., an interview was conducted with PCT #5. PCT #5 stated heparin was a medication and was to be stored in the clean area where the the medication was prepared for use on patients. PCT #5 stated the countertop where the syringes were observed was not a medication storage area. PCT #5 stated patient information was printed on a label attached to each syringe and there was a risk of patient information not being secured, as well as a safety risk to patients having access to the medications and the needles attached to the syringes. PCT #5 also stated the medication could fall to the floor which was an infection risk. iv. On 8/1/24 at 2:15 p.m., an interview was conducted with registered nurse (RN) #6. RN #6 stated heparin was prepared by patient care technicians at a designated medication station. RN #6 stated medication was not to be stored in an area that could be accessed by patients. RN #6 further stated there was a safety risk of patients removing the medication syringes, which included a needle.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 45020 Based on observations, interviews, and document review, the facility failed to ensure patient care staff performed hand hygiene when a central venous catheter (CVC, a device inserted through the skin for direct access to a large vein in the patient for dialysis treatment) was accessed according to facility policy in one of two observations of staff accessing CVCs. Additionally, the facility failed to ensure patient care staff allowed dry time after the hub of the CVC catheter was cleaned in four of four observations of staff cleaning CVCs. Findings include: Facility policies: The CVC with Clearguard Hemodialysis (HD) (cleaning the blood using a machine and a filter) Antimicrobial End Caps Procedure read, perform a 15-second hub scrub of the CVC during the process of connecting or disconnecting from the bloodlines, or if the patient is disconnected during treatment for any reason. Perform hand hygiene per procedure. Remove old dressing and discard. Verify that both arterial and venous catheter limbs (tubing) are clamped. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. Holding catheter and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol for a minimum of 30 seconds, and apply to the CVC exit site in a “back and forth” pattern. Then wait 60 seconds for air dry time. Clean each CVC limb and cap with a new large alcohol prep pad. Remove gloves and discard, perform hand hygiene per procedure and re-glove. Apply antibiotic ointment to exit site, if prescribed. Place sterile 2x2 gauze over the catheter exit site leaving connections accessible. Seal edges of gauze with tape. Apply label to the dressing indicating date the dressing change was performed and initials of the teammate performing procedure. Remove gloves and discard, perform hand hygiene per procedure and re-glove. Holding catheter, place sterile 4x4 under catheter limbs. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub (the ends of the CVC connecting to the bloodlines or cap) with a new alcohol prep pad. Scrub each CVC hub for 15 seconds. Hold the limbs until the antiseptic has dried. The Infection Control policy read, all teammates will perform hand hygiene prior to gloving and immediately after removal of gloves, after contamination with blood or other infectious material, and after patient and dialysis delivery system contact. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station. Gloves should be changed when soiled, when going from a “dirty” area or task to a “clean” area or task, and when moving from a contaminated body site to a clean body site of the same patient. 1. The facility failed to ensure patient care staff performed hand hygiene before the CVC access site was cleaned according to facility policy. Additionally, the facility failed to ensure patient care staff allowed dry time after the hub of the CVC catheter was cleaned. A. Observations i. On 7/31/24 at 7:20 a.m., an observation was conducted of a CVC initiation at station #17. PCT #1 removed the caps of the CVC and scrubbed the hubs with an alcohol pad for 15 seconds, after which they immediately attached a syringe to each hub and withdrew blood. The hubs were visibly wet when the syringe was attached. When asked if there was a dry time to the hubs after alcohol scrub, PCT #1 stated there was no dry time. ii. On 7/31/24 at 11:03 a.m., an observation was conducted of a CVC end of treatment procedure at station #17. After the dialysis lines were removed from the patient the CVC was prepared for the patient to leave the facility. PCT #2 removed the caps of the CVC and scrubbed the hubs with an alcohol pad for 15 seconds, after which they immediately applied new caps to each hub while the hub remained visibly wet. iii. On 7/31/24 at 2:48 p.m., an observation was conducted of a CVC end of treatment procedure at station #11. After the dialysis lines were removed from the patient the CVC was prepared for the patient to leave the facility. PCT #3 scrubbed the blue hub for 15 seconds and a new blue cap was immediately applied. PCT #3 stated there was no dry time. The red hub was scrubbed for 15 seconds and a new red cap was immediately applied to the hub. Both hubs were visibly wet when the new caps were applied. This was in contrast to the CVC with Clearguard Hemodialysis (HD) Antimicrobial End Caps Procedure policy, which read, one at a time, each CVC hub was to be disinfected with a new alcohol prep pad. Each CVC hub was to be scrubbed for 15 seconds. The limbs were to be held until the antiseptic was dry. iv. On 7/31/24 at 10:46 a.m., an observation was conducted of a CVC initiation of treatment at station #1. PCT #4 . PCT #4 removed the gauze covering the patient’s CVC access and the gauze around the catheter limbs. PCT #4 swabbed the area on and around the CVC access for 60 seconds. Hand hygiene was not observed between these steps. PCT #4 removed the blue cap of the CVC, no hub scrub observed, a syringe was immediately attached and blood was withdrawn. PCT #4 then removed the red cap of the CVC and a syringe was immediately attached. No hub scrub with an alcohol pad was observed. Without hand hygiene performed, or gloves changed, PCT #4 applied a new gauze dressing over the patient’s CVC access site and secured it with tape. This was in contrast to the CVC Procedure which read, the old dressing was to be removed and discarded. Gloves were to be removed, discarded and hand hygiene was to be performed. This was also in contrast to the Infection Control policy which read, gloves were to be changed when soiled, going from a “dirty” area or task to a “clean” area or task, and going from a contaminated body site to a clean body site of the same patient. B. Interviews i. On 8/1/24 at 12:58 p.m., an interview was conducted with PCT #5. PCT #5 stated CVC care required multiple glove changes because patients were prone to infection. PCT #5 stated CVC hubs were to be scrubbed with an alcohol pad for 15 seconds, and allowed to air dry before a syringe was attached to withdraw blood from the line. PCT #5 stated CVC care was important because there was a risk of infection which could cause sepsis or death. ii. On 8/1/24 at 12:16 p.m., an interview was conducted with PCT #4. PCT #4 stated CVC care was important because the CVC was near the patient’s heart and was prone to infection. PCT #4 stated they believed the dry time after alcohol scrub to the CVC hub was 30 seconds. PCT #4 stated glove changes were important so the risk of infection was minimized. PCT #4 stated if policy was not followed for CVC care there was a risk of infection which could cause death. iii. On 8/1/24 at 2:15 p.m., an interview was conducted with registered nurse (RN) #6. RN #6 stated CVC hubs were to be scrubbed with alcohol and allowed to air dry because alcohol needed dry time to disinfect the area. RN #6 stated glove changes were important to decrease the risk of infection and policies were in place to prevent infection. RN #6 stated the risk of an infection to a CVC site included sepsis and possible death.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 45020 Based on observations, interviews, and document review, the facility failed to have a process in place to ensure expired medications and medical supplies were removed and not available for use in one of one medication storage areas. Findings include: Facility policies: The infection control for dialysis Centers Policy read, the purpose of this policy is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Supplies will be stored in a manner that maintains their integrity. Expiration date and package integrity will be verified prior to use. Anytime the integrity of a package is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used. The Physical Environment policy read, the purpose of this policy is to provide guidance on the physical environment of the dialysis facility and treatment area. The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and water treatment systems are maintained and operated in accordance with manufacturer’s recommendations. 1. The facility failed to have a process in place to ensure expired medications were removed from the facility’s inventory and not available for use. A. Observations i. On 7/30/24 at 12:58 p.m., the medication preparation and storage area was observed. Observation of the intravenous antibiotic medication storage area revealed a box of 12 Cefazolin 1 gram (G) vials with an expiration date of 5/2024. Further observation of the storage area revealed a box of 23 Tazicef 1G vials with an expiration date of 4/2024. During the observation, registered nurse (RN) #6 stated the antibiotics were used when a patient had a diagnosis of an infection and that expired medications could have lost efficacy (desired beneficial effect). RN #6 stated the administrative administrator (AA) checked for outdated supplies. The observation was in contrast to facility policies, which read expired medications were to be discarded and a program to verify that all equipment, including emergency equipment, dialysis delivery systems, and water treatment systems were maintained and operated in accordance with manufacturers’ recommendations. B. Interviews i. On 8/1/24 at 2:15 p.m., an interview was conducted with RN #6. RN #6 stated the expired medications were on the treatment floor and available for use. RN #6 stated they checked for expiration dates before administering medication, but was unsure if other nurses checked. RN #6 stated they were unsure if there was a risk if these medications expired and were administered to a patient. ii. On 8/1/24 at 2:53 p.m., an interview was conducted with the facility administrator (FA) #7. FA #7 stated the AA was responsible for removing expired supplies and had assumed the AA also removed expired medications. FA #7 stated the risk of expired medications, if given to patients, was a loss of efficacy. iii. On 8/1/24 at 3:15 p.m., an interview was conducted with AA #8. AA #8 stated they checked for outdated supplies, but this did not include medications. AA #8 stated they counted on the nurses to check medications and there was a miscommunication between staff for this responsibility. AA #8 stated the risk of expired medications, if given to patients, was a loss of efficacy.”

“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: 45020 Based on observations, document review, and staff interviews, the facility failed to maintain the storage of peracetic acid (a highly corrosive liquid used as an antimicrobial agent and sanitizer) at the temperature instructed by the manufacturer and facility policies in one of one storage areas observed which contained this acid. Findings include: Facility policies: The Chemical Use policy read, the purpose of this policy is to provide guidance for preparation of approved specific chemicals used in a facility. Peracetic acid is to be stored separate from other chemicals, especially bleach. It is to be stored in a cool, dry area (32°F-75°F). The Physical Environment policy read, the purpose of this policy is to provide guidance on the physical environment of the dialysis facility and treatment area. The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and water treatment systems are maintained and operated in accordance with manufacturer’s recommendations. Supplies are stored as to minimize deterioration, contamination or breakage. The Incoming Supply, Storage and Utilization of Peracetic Acid policy read, The purpose of this policy is to provide guidance for peracetic acid (PAA) management in the facility and to provide guidance for storage and utilization of peracetic acid (PAA). The Facility Administrator/designee is responsible for supervising the safe handling, storage and utilization of PAA within the facility. The PAA storage cabinet will be located in a secure, temperature-controlled and well ventilated area. References: The Minncare HD (peracetic acid) Safety Data Sheet read, Use of substance/mixture: Sanitizing of RO (reverse osmosis) systems. Precautionary statements: Keep away from heat. Conditions for safe storage, Store at temperatures not exceeding 23.9 degrees C (75 degrees F). A notice from the manufacturer of Minncare, which was signed as reviewed by the facility on November 4, 2021, read, the recommended storage temperature for Minncare is between 32-75 degrees Fahrenheit (F). The shelf-life of MINNCARE Cold Sterilant and MINNCARE HD Disinfectant takes into account short-term exposures to elevated temperatures above 75 degrees F. In this context, “short-term” refers to time periods measured by days and weeks, not years. Such conditions can be experienced while the product is being warehoused and shipped. Elevated temperatures will increase the activity of the solution and can cause the container to inflate with oxygen due to the conversion of peracetic acid to hydrogen peroxide and acetic acid and the conversion of the hydrogen peroxide to oxygen and water. Elevated temperatures can also cause a breakdown of PAA (peracetic acid) and a potential decrease in efficacy. In addition, exposure to temperatures greater than 75 degrees F will increase the chemical reaction between the chemicals and the container, which may embrittle the container’s material causing it to produce a crack and possibly leak chemicals. 1. The facility failed to maintain storage of peracetic acid in accordance with the manufacturer’s IFU and facility policies. a. A review of the temperature log for the storage area where peracetic acid was stored revealed from 6/14/24 to 7/31/24 two days had no temperature recorded on days the facility had patients who received treatment. In addition, the log revealed seven days with temperatures noted to have been out of the range specified by the manufacturer with no evidence of the biomedical technician (biomed) being notified or of interventions implemented to decrease the temperature. For example: i. On 7/31/24 the temperature was recorded at 88 degrees F. ii. On 7/30/24 the temperature was recorded at 81.5 degrees F. iii. On 7/29/24 the temperature was recorded at 81.5 degrees F. iv. On 7/27/24 the temperature was recorded at 80.6 degrees F. v. On 6/18/24 the temperature was recorded at 77.9 degrees F. vi. On 6/17/24 the temperature was recorded at 77.8 degrees F. vii. On 6/14/24 the temperature was recorded at 78.6 degrees F. b. On 8/1/24 at 12:58 a.m., an interview was conducted with patient care technician (PCT) #5. PCT #5 stated peracetic acid was used to disinfect the water system used for dialysis treatments. PCT #5 stated the room temperature checks were conducted in the morning before the dialysis clinic opened. PCT #5 stated if any readings were out of range, the process was to notify the facility’s biomedical technician, as well as the nurse. c. On 8/1/24 at 2:15 p.m., an interview was conducted with registered nurse (RN) #6. RN #6 stated they were unsure what peracetic acid was used for. RN #6 stated PCTs checked the room temperatures in the mornings before the clinic opened. RN #6 stated they were not aware some temperatures were out of range and had the expectation to have been notified if an out of range temperature occurred. d. On 8/1/24 at 9:53 a.m., an interview was conducted with biomed technician (Biomed) #10. Biomed #10 stated peracetic acid was a chemical used to disinfect the reverse osmosis machine in the water room. Biomed #10 stated they were aware of some out of range storage temperatures but did not document date or times of notifications. Biomed #10 stated the facility had a letter from the manufacturer of the peracetic acid, but it was vague on what the manufacturer determined as an acceptable time for the peracetic acid to be stored at temperatures out of range.. Biomed #10 stated this facility was not considered a warehouse. Biomed #10 stated they had the expectation to have been notified by staff for all out of range readings and was unsure if an incident report would have been completed for each occurrence. Biomed #10 stated they were unsure if the out of range temperature could decrease effectiveness of the peracetic acid. e. On 8/1/24 at 2:53 p.m., an interview was conducted with facility administrator (FA) #7. FA #7 stated they had recently moved the peracetic acid from one storage room to another and had not discussed the move with biomed before moving it. FA #7 stated they had the expectation of biomed to have been notified by staff for all out of range readings.”