Davita Arvada Dialysis Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 48269 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition §494.40 - Condition: Water and dialysate quality, was out of compliance. V184 - The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimize the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. Based on observations, and interviews, the facility failed to ensure the water purification and storage system was secure to prevent unauthorized access.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 48269 Based on observations and interviews, the facility failed to secure the water purification and storage system to prevent unauthorized access. Findings include: Reference: The water treatment systems minimum component requirement policy read, new and renovated water purification and distribution systems should be located in a secure area that is readily accessible to authorized teammates. 1. The facility failed to ensure a temporary water purification system was secured from unauthorized access during its use while the facility’s original system was out of service. A. Observations i. Observations of the water room on 11/13/23 at 10:45 a.m. and on 11/20/23 at 12:20 p.m. revealed a temporary deionized (DI) water system (a process done when there is an immediate need for purified water) in the hallway outside of the water room. Four tanks were located in the hallway with hoses connecting the tanks to the inside of the water room. The door to the water room was removed. A new reverse osmosis (RO) water system (a water purification process that uses a semi-permeable membrane to separate water molecules from other substances) was set in place but not yet installed. There was no lock on the door to the treatment floor at the end of the hallway securing the water system from unauthorized access. This was in contrast to the water treatment systems minimum component requirement policy which read, new and renovated water purification and distribution systems should have been located in a secure area that was readily accessible to authorized teammates. B. Interviews i. On 11/20/23 at 2:55 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated the water room should have been locked to keep the water safe and prevent unauthorized people from entering. She said this was important because the water used for patient treatments had to be pure. Further, she stated the staff would not want someone tampering with the water which could put patients at risk of contamination. ii. On 11/20/23 at 2:35 p.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated the door to the water room should have been kept secure to audit access and to ensure that only staff had access. She said staff needed to ensure no one tampered with the water because that could be dangerous. RN #1 stated that staff needed access to the water room to perform chlorine checks according to policy or there could be chlorine in the water putting patients at risk for illness. Further, she stated if the acid in the water room was tampered with it could lead to possible negative patient outcomes, including cardiac arrest (a sudden stop in the function of the heart). RN #1 said, in general, patients were at risk for harm if the water room was not secured. iii. On 11/20/23 at 9:33 a.m., an interview was conducted with the biomedical operations manager (Manager) #4. Manager #4 stated the door to the water room should have been kept closed to prevent unauthorized access. He said the water room should have been kept secure to protect patients and ensure the water was safe. Manager #4 explained when the RO system failed, a temporary DI system was installed. Manager #4 stated the DI system was placed in the hallway due to the physical layout of the water room and to keep the shortest distance for the water treatment system. Manager #4 stated that if someone was intent on causing harm they would be able to access the system if the door to the water room was unsecured. Further, he said the risk to patients if an unauthorized individual tampered with the water system could be potential hemolysis (the rupture or destruction of red blood cells) from contaminated water used during hemodialysis treatments. iv. On 11/21/23 at 7:40 a.m., an interview was conducted with the medical director (Director) #3. Director #3 stated a door was needed to the water room to prevent someone from coming in and tampering with the water. Director #3 said the main reason to keep the water room door secure was to prevent water contamination by someone untrained in sterile conditions or who would purposely put chemicals in the water to contaminate it. Director #3 stated although the water system was monitored, it did not have continuous monitors for endotoxins (a toxin present inside a bacterial cell that was released when the cell disintegrated) or bacterial contaminations that could harm a patient during treatment. She said she would be concerned that patients could get infections and even go into shock if they received contaminated water during a dialysis treatment.”

“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: 46675 Based on observations, document review, and interviews, the facility failed to ensure medical supplies had not expired and were unavailable for patient use in two of two supply storage areas observed. Findings include: Facility policy: The Infection Control For Dialysis Facilities policy read, supplies will be stored in a manner that maintains their integrity. 1. The facility failed to ensure expired medical supplies were discarded and not available for patient use. A. Observations i. On 11/13/23 at 7:25 a.m., observations of the treatment floor revealed four bottles of ExSept skin and exit site wound cleanser, expired on 7/8/23. ii. On 11/13/23 at 11:00 a.m., an observation of the supply storage room revealed a one gallon jug of liquid acid concentrate (a chemical used to assist with the removal of waste from the body), expired on 5/31/23. B. Interviews i. On 11/20/23 at 2:35 p.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated the facility utilized the first in first out approach to monitor medical supplies for expiration date. RN #1 stated the facility had no documented formal process in place to monitor medical supplies for expiration date. RN #1 stated it was important to monitor medical supplies for expiration date to keep patients safe and patients were at risk for an adverse reaction to the supply if expired medical supplies were used for patient care. ii. On 11/20/23 at 2:55 p.m., an interview was conducted with patient care technician (PCT) #2. PCT #2 stated medical supplies were rotated when new supplies were received. PCT #2 stated the facility had no documented formal process in place to monitor medical supplies for expiration date. PCT #2 stated expired medical supplies were important to monitor to ensure patient safety and patients were at risk for contamination and the supply to not work as intended if expired and used in patient care. iii. On 11/21/23 at 7:40 a.m., an interview was conducted with medical director (Director) #3. Director #3 stated the facility visually monitored the treatment floor for expired supplies on a quarterly basis, but nothing was documented. Director #3 stated expired medical supplies placed the patient at risk for developing an adverse reaction to the specific supply or possible infection if used in patient care. This was in contrast to The Infection Control For Dialysis Facilities policy which read, supplies were to be stored in a manner that maintained their integrity.”

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 46675 Based on interviews and document review, the facility failed to ensure the medical staff met regularly and maintained written records of their meetings. Findings include: Reference: The Medical Staff Bylaws read, the prerogatives of an attending staff member shall be to attend medical staff meetings. Each facility medical staff shall hold staff meetings as needed to address patient care needs, or more frequent meetings as required by state or local law. At each medical staff meeting, the medical director shall determine the order of business for that meeting, as required by state law. Where warranted, minutes of all meetings shall be prepared and shall include a record of attendance and the results of votes taken on each matter considered. Copies of minutes of a meeting of a facility medical staff shall be made available and maintained on file as appropriate. 1. The facility failed to ensure the medical staff met regularly and maintained written records of those meetings. A. Document review i. Upon request, the facility was unable to provide documentation of medical staff meetings and minutes from those meetings. This was in contrast to the Medical Staff Bylaws which read, staff members were to attend medical staff meetings. Each medical staff held staff meetings as needed to address patient care needs and as required by state law. Minutes of all meetings were prepared and included a record of attendance and the results of votes taken on each matter considered. Copies of minutes were made available and maintained on file. B. Interviews i. On 11/21/23 at 7:40 a.m., an interview was conducted with medical director (Director) #3. Director #3 stated she met with the other provider from the facility on a bi-monthly basis. Director #3 further stated no meeting minutes were taken during meetings between the two providers at the facility. Director #1 stated patients were at risk for fragmented care if providers did not meet regularly and document communication. This was in contrast to the Medical Staff Bylaws which read, staff members were to attend medical staff meetings. Each medical staff held staff meetings as needed to address patient care needs and as required by state law. Minutes of all meetings were prepared and included a record of attendance and the results of votes taken on each matter considered. Copies of minutes were made available and maintained on file.”