Davita Commerce City Dialysis

“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 ensure medications were properly secured in two of two medication storage areas. V122 - [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-](ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. - Based on observations, interviews, and document reviews, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station per facility policy in one of two observations of dialysis station cleaning. Specifically, staff did not apply sufficient disinfectant so the surface was visibly wet. Additionally, the facility failed to ensure the patient treatment chair and the wall box (connections for the dialysis machine to receive acid and base concentrates and dispose of waste products) were cleaned with separate disinfectant cloths. V143 - [The facility must-](2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and - Based on observations, document review and interviews, the facility failed to ensure clinical staff demonstrated compliance when dispensing and administering intravenous (IV) medication from vials. Specifically, the facility failed to label a multi-dose vial (MDV) to ensure the correct expiration date was noted in one of two observations. 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 allowed dry time after the hub of the central venous catheter (CVC a device inserted through the skin for direct access to a large vein in the patient for dialysis treatment) was cleaned in accordance with facility policy in four of four observations of CVC procedures.”

“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. V403 - 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 implement and maintain a program to ensure that all equipment was maintained in accordance with facility policy. Specifically, 7 out of 19 treatment chairs had torn surfaces in the seat cushion, footrest, sidearm panel and/or armrests, which did not allow for effective disinfection of the surfaces.”

“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 ensure medications were properly secured in two of two medication storage areas. Findings include: Facility policy: 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. References: According to the manufacturer’s instructions for use for heparin, heparin sodium injection is an anticoagulant. Warnings and precautions are hemorrhage. Fatal cases have occurred. According to the manufacturer’s instructions for use for sodium thiosulfate (a medicine used to treat calcium buildup in small blood vessels). The medication is intended for intravenous injection. Each vial contains 12.5 grams of sodium thiosulfate, 8 mg boric acid, and 4.4 mg of potassium chloride. Patients should be informed of the possibility of hypotension (low blood pressure) and the need for close monitoring of blood pressure and oxygenation. 1. The facility failed to ensure heparin (a medication used to stop blood from forming blood clots) and sodium thiosulfate (a medication used to treat calcium buildup in small blood vessels) were properly stored and secured in the patient treatment area. A. Observations i. On 10/22/24 at 11:21 a.m., an observation was conducted in the treatment area. An unlocked drawer which contained 45 sealed vials of heparin and one open vial was observed. ii. On 10/22/24 at 11:23 a.m., an observation was conducted in the medication area of the treatment floor. In a drawer, which did not have a lock available, 28 boxes of sodium thiosulfate injection were observed. These observations were in contrast to the Medication policy which read, medications were to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate. B. Interviews i. On 10/23/24 at 9:23 a.m., an interview was conducted with patient care technician (PCT) #1. PCT #1 stated the nurse who closed the facility the previous day was expected to ensure the medications were secured in locked drawers. PCT #1 stated heparin was locked to prevent unauthorized access to this medication which could be tampered with and cause patient harm. PCT #1 stated heparin was a blood thinner and there was a risk of blood loss if it were to be used improperly. ii. On 10/23/24 at 10:21 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated medications were to be locked and secured by the nurse at the end of each shift. RN #3 stated if medications were not securely stored, there was a risk the medication could be tampered with which could cause contamination or adverse reactions, including death, if administered to patients. iii. On 10/23/24 at 12:01 p.m., an interview was conducted with facility administrator (FA) #4. FA #4 stated medications stored in drawers were to be locked at the end of each shift. FA #4 stated heparin was an anticoagulant and could cause excessive bleeding if misused. FA #4 further stated if medications were not secured there was a risk the medications, which were necessary for patient treatment, could be removed from the facility.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 45020 Based on observations, interviews, and document reviews, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station per facility policy in one of two observations of dialysis station cleaning. Specifically, staff did not apply sufficient disinfectant so the surface was visibly wet. Additionally, the facility failed to ensure the patient treatment chair and the wall box (connections for the dialysis machine to receive acid and base concentrates and dispose of waste products) were cleaned with separate disinfectant cloths. Findings include: Facility policy: The Infection Control for Dialysis Facilities policy read, the purpose of this policy is to minimize the spread of infections or blood borne pathogens in the dialysis facility environment. At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings (e.g., dialysis chair). Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. Disinfection should be completed by using a wiping motion with friction. Sufficient disinfectant should be applied so that surfaces are visibly wet. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. Reference: According to the manufacturer’s instructions for use for Pure Bright germicidal ultra bleach, for sanitizing non-porous surfaces, prepare a solution of this product, wash surface, let stand 5 minutes to air dry. 1. The facility failed to ensure dialysis chairs were cleaned and disinfected between patient treatments according to facility policy. A. Observation i. On 10/21/24 at 10:10 a.m., patient care technician (PCT) #5 was observed as they disinfected the dialysis chair at station #8. PCT #5 opened the right side armrest to clean the surfaces in between the chair and the armrest, cleaned the middle section of the chair, then cleaned the wall box. Using the same cloth, PCT #5 opened the left side armrest to clean the surfaces in between the chair and the armrest. The dialysis chair was not visibly wet and the same disposable cloth was used for the chair and wall box. This observation was in contrast to the Infection Control for Dialysis Facilities policy which read, sufficient disinfectant should be applied so that surfaces are visibly wet. B. Interviews i. On 10/23/24 at 9:23 a.m., an interview was conducted with PCT #1. PCT #1 stated the process for a dialysis chair to be cleaned was to use a bleach solution on disposable cloths. PCT #1 stated the wall box was to be cleaned last as it was the area where wastewater from the dialysis machine went. PCT #1 stated it was important the chair was visibly wet to ensure the entire chair was cleaned. PCT #1 stated it was important to clean dialysis chairs thoroughly between patients because there was a risk of infection. ii. On 10/23/24 at 10:21 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated dialysis chairs were to be cleaned after each use with a bleach solution and a new disposable cloth was to be used for each arm and the middle. RN #3 stated the wall box was to be cleaned after the chair because the wall box contained an acid solution that could irritate a patient’s skin.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45020 Based on observations, document review and interviews, the facility failed to ensure clinical staff demonstrated compliance when dispensing and administering intravenous (IV) medication from vials. Specifically, the facility failed to label a multi-dose vial (MDV) to ensure the correct expiration date was noted in one of two observations. Findings include: Facility policy: The Medication policy read, the purpose of this policy is to provide guidance for the safe and aseptic preparation of all medications. If the medication is not immediately administered, the medication must be labeled with the patient name, name of the medication, date, time prepared, dose, and initials of the teammate preparing the medication. 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 or as directed by the manufacturer. Each vial is labeled with the initials of the person opening the vial and the expiration date. Reference: According to the manufacturer’s instructions for use for heparin, heparin sodium injection is an anticoagulant. Warnings and precautions are hemorrhage. Fatal cases have occurred. 1. Facility staff failed to label multi-dose vials of medication with a date when opened. A. Observation i. On 10/21/24 at 2:53 p.m., an observation of the facility’s medications revealed an open MDV of heparin on a countertop in a medication preparation area. There was no date on the vial to indicate when the medication was opened. This observation was in contrast to facility policy which stated medication must be labeled with the date, time, and initials of the teammate. B. Interviews i. On 10/23/24 at 9:23 a.m., an interview was conducted with patient care technician (PCT) #1. PCT #1 stated when an MDV was opened, the staff member was expected to label the vial with the time, date, and their initials. PCT #1 stated if the vial was not dated when it was opened, other staff members would not know when the vial was opened and could administer an expired medication to the patient. ii. On 10/23/24 at 10:21 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated it was important to label MDVs to ensure the medication was still safe to be administered to the patient. RN #3 stated if the medication was not labeled appropriately and expired and was then administered to the patient, there was a risk the medication could be contaminated and cause an infection or lose potency.”

“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 allowed dry time after the hub of the central venous catheter (CVC a device inserted through the skin for direct access to a large vein in the patient for dialysis treatment) was cleaned in accordance with facility policy in four of four observations of CVC procedures. Findings include: Facility policy: The CVC with Clearguard Hemodialysis (HD) (cleaning the blood using a machine and a filter) Antimicrobial End Caps Procedure read, holding the catheter, place a sterile 4x4 gauze under catheter limbs. Using aseptic (free from contamination) 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. 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 10/21/24 at 8:05 a.m., an observation was conducted of a CVC initiation of treatment at station #6. Patient care technician (PCT) #2 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 the alcohol scrub, PCT #2 stated there was no dry time. ii. On 10/21/24 at 9:58 a.m., an observation was conducted of a CVC end of treatment procedure at station #8. After the dialysis lines were removed from the patient the CVC was prepared for the patient to leave the facility. PCT #5 removed the caps of the CVC and scrubbed the hubs with an alcohol pad for 7 seconds after which they immediately applied new caps to each hub while the hub remained visibly wet. iii. On 10/21/24 at 11:17 a.m., an observation was conducted of a CVC end of treatment procedure at station #6. After the dialysis lines were removed from the patient the CVC was prepared for the patient to leave the facility. PCT #2 scrubbed the blue hub for 20 seconds and a new blue cap was immediately applied. 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 iv. On 10/21/24 at 2:56 p.m., an observation was conducted of a CVC initiation of treatment at station #6. PCT #5 removed the caps of the CVC and scrubbed the hubs with an alcohol pad for 30 seconds, after which they immediately attached a syringe to each hub and withdrew blood. The hubs were visibly wet when the syringe was attached. This was in contrast to the CVC with Clearguard Hemodialysis Antimicrobial End Caps Procedure policy which read, scrub each CVC hub for 15 seconds. Hold the limbs until the antiseptic has dried B. Interviews i. On 10/23/24 at 9:23 a.m., an interview was conducted with patient care technician (PCT) #1. PCT #1 stated CVC hubs were to be scrubbed with alcohol for 15 seconds and allowed to fully air dry because alcohol needed dry time to disinfect the area. PCT #1 stated it was important to follow facility policy for CVC care because the CVC line went directly to the patient’s heart and there was a risk of infection and sepsis (a severe response to infection) which could be life threatening. ii. On 10/23/24 at 10:21 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated CVC hubs were to be scrubbed with alcohol for 15 seconds and allowed to air dry. RN #3 stated CVC hubs were to be scrubbed with alcohol and allowed to air dry because alcohol needed dry time to disinfect the area and to prevent alcohol from getting into the system. RN #3 stated policies were in place to prevent infection. RN #3 stated the risk of an infection to a CVC site included infection and possible death.”

“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 implement and maintain a program to ensure that all equipment was maintained in accordance with facility policy. Specifically, 7 out of 19 treatment chairs had torn surfaces in the seat cushion, footrest, sidearm panel and/or armrests, which did not allow for effective disinfection of the surfaces. Findings include: Facility policies: 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. The Preventive Maintenance Schedules for Equipment policy read, the purpose of this policy is for the dialysis delivery systems and all ancillary equipment, to be maintained in good working condition and operating according to the manufacturer’s specifications. Preventive maintenance (PM) schedules must be made in accordance with the manufacturer’s recommendation for all equipment used to perform a patient treatment. A copy of the equipment PM schedule will be filed in the appropriate Equipment Maintenance Manual. All miscellaneous equipment will receive PM performed by a trained Biomed teammate or outside vendor per manufacturer’s recommendations. Reference: The Champion Chair Operations Instructions and Service Manual read, general maintenance and care of chairs: Each facility should check their chairs and set their own maintenance schedule. 1. The facility failed to maintain and repair patient treatment chairs to allow effective cleaning and disinfection. a. A tour of the patient treatment area on 10/22/24 at 8:17 a.m. revealed 7 out of 19 dialysis treatment chairs had torn surfaces on the seat cushion, arm rests and/or footrests which had not effectively been repaired. The torn surfaces did not allow effective disinfection due to the broken surfaces. For example: i. Station #4’s patient dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 9 inches long. The backrest was noted to have a large rip which measured approximately 8 inches long, fabric and foam underneath were visible. ii. Station #18’s patient dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 12 inches long, fabric and foam were visible. The lower edge of the left side arm had an “L” shaped rip, which measured approximately 1.5 inches long, foam was visible, and a smaller 1 inch square area revealed the fabric was visible. iii. Station #12’s patient dialysis chair was noted to have a large section of the plastic covering missing, which measured approximately 4 inches by 4 inches. The plastic covering was peeled back revealing the fabric. iv. Multiple other dialysis chairs were noted to have torn, ripped, and open areas in the seat and armrest cushions. b. On 10/23/24 at 9:23 a.m., an interview was conducted with patient care technician (PCT) #1. PCT #1 stated dialysis chairs were cleaned with a bleach solution after each patient to remove any blood to prevent any cross-contamination between patients. PCT #1 stated ripped and cracked chair surfaces could not be cleaned well. PCT #1 stated there was a risk of infection, including HIV (human immunodeficiency virus)( a virus that attacks the body’s immune system) if the dialysis chairs were not cleaned per policy. c. On 10/23/24 at 9:56 a.m., an interview was conducted with PCT #2. PCT #2 stated dialysis chairs were cleaned with a bleach solution after each patient to remove any blood to prevent any cross-contamination between patients. PCT #4 stated the facility used disposable drapes to cover each chair seat, but these drapes sometimes ripped while the patient was on treatment as they moved in their seat and the drapes did not cover the dialysis chair arms. d. On 10/23/24 at 12:10 p.m., an interview was conducted with facility administrator (FA) #4. FA #4 stated quarterly preventative maintenance inspections occurred, however, FA #4 was only able to provide an undated physical plant inspection and stated it was completed in July of 2024. The undated inspection revealed five chairs had rips in the covers. FA #4 stated two new chairs had been ordered, however, they were not able to show evidence of the order. FA #4 stated the dialysis chair surfaces were to be cleaned between each patient and if the chairs were not properly cleaned, there was a risk of infection.”