Davita Sapulpa Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 34696 Based on record review and interview, the facility failed to ensure that all Hepatitis B susceptible patients had monthly Hepatitis B Surface Antigen (HBsAg) testing, citing six of sixty Hepatitis B susceptible patients (Patient #4, #5, #6, #7, #8, and #9). This presented a risk to patient health and safety. Findings included: 1. The facility failed to perform monthly HBsAg testing on six of sixty Hepatitis B susceptible patients (Patient #4, #5, #6, #7, #8, and #9). Cross refer to V 124.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 34696 Based on observations, record review, and interview, the Governing Body failed to demonstrate respoonsibility for the opereraation of the facility, health care, and safety of the patients, staff, and public. Findings included: 1. The facility failed to ensure that all Hepatitis B susceptible patients had monthly Hepatitis B Surface Antigen (HBsAg) testing, citing six of sixty Hepatitis B susceptible patients (Patient #4, #5, #6, #7, #8, and #9). This presented a risk to patient health and safety. Cross refer to V 110. 2. The facility failed to provide a physical environment that was safe and free from defects in two of five areas (water treatment area and hemodialysis treatment area). Cross refer to V 400.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 34696 Based on record review and interview, the facility failed to perform monthly Hepatitis B Surface Antigen (HBsAg) testing on six of sixty Hepatitis B susceptible patients (Patient #4, #5, #6, #7, #8, and #9). Findings included: A review of the “Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance” policy revision date 10/2023 included, “All patients will be routinely tested for Hepatitis B virus (HBV)...Results will be reviewed promptly to verify that patients are managed appropriately based on their testing results...Documentation of the following will remain in the patient’s current active medical record...HBV serology results such as Hepatitis B surface antibodies (HBsAb or anti-HBS)...Hepatitis B total core antibody (total anti-HBc or HBcAb) and HBsAg...If HBsAb is less than 10 milli-international units per milliliter (mIU/mL), consider the patient susceptible...to Hepatitis B infection and monthly HBsAg testing is required.” 1. The facility’s “Vaccinations and Surveillance” report dated 11/15/2023 indicated Patient #4’s HBsAb result on 08/19/2023 was greater than or equal to zero. There was no documented evidence the monthly HBsAg drawn in 09/2023. 2. The facility’s “Vaccinations and Surveillance” report dated 11/15/2023 indicated Patient #5’s HBsAb result on 06/21/2023 was less than three. There was no documented evidence the monthly HBsAg drawn in 08/2023. 3. The facility’s “Vaccinations and Surveillance” report dated 11/15/2023 indicated Patient #6’s HBsAb result on 07/10/2023 was six. There was no documented evidence the monthly HBsAg drawn in 10/2023. 4. The facility’s “Vaccinations and Surveillance” report dated 11/15/2023 indicated Patient #7’s HBsAb result on 06/13/2023 was less than three. There was no documented evidence the monthly HBsAg drawn in 09/2023. 5. The facility’s “Vaccinations and Surveillance” report dated 11/15/2023 indicated Patient #8’s HBsAb result on 06/13/2023 was less than three. There was no documented evidence the monthly HBsAg drawn in 09/2023 and 10/2023. 6. The facility’s “Vaccinations and Surveillance” report dated 11/15/2023 indicated Patient #9’s HBsAb result on 04/04/2023 was less than three. There was no documented evidence the monthly HBsAg drawn from 01/2023 to 09/2023. On 11/16/2023 at 11:20 AM, the Group Facility Administrator (Personnel #1) said the monthly HBsAgs for Patients #4, #5, #6, #7, #8, and #9 were not drawn.”

“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: 34696 Based on observation, interview, and record review, the facility failed to maintain the building to ensure the safety of the patients and the staff in three of three areas (storage room, water treatment area, and hemodialysis treatment area). Findings included: A review of the “Physical Environment” policy revision date 04/2018 included: “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public...The dialysis facility will implement and maintain a program to verify that all equipment including...water treatment systems are maintained...systems to assure patient safety will be in place...Access to...water treatment systems, supply storage, and dialysis equipment is restricted to authorized personnel only...Access limitation does not preclude visitors or tours by individual(s) authorized and supervised by facility personnel.” On 11/15/2023, the following was observed: At 1:50 PM, the storage room was not secure. The door to the storage room was propped open. At 2:00 PM, a liquid was observed spilling from underneath the door of the water treatment area into the hallway. The Manager of Clinical Services (MCS, Personnel #2) turned the handle of the door leading into the water treatment area. The security key pad was not engaged. The door opened. Upon entering the water treatment area, it was observed that the liquid was all over the floor inside the water treatment area. The MCS said the staff had cleaned the floor. At 2:20 PM, it was observed in the hemodialysis treatment area that the counter top at the “Dirty Sink” near station #4 was covered with blue pads that had been previously wetted and dried with yellowish-brown stains. The under-counter cabinet was dirty, stained, and had old equipment stored underneath. At the time of the findings, the MCS said the staff should maintaining the area. On 11/15/2023 at the time of the findings the MCS said the door to the storage room should be closed unless deliveries are being made. The MCS said the door to water treatment area should be locked at all times. The MCS said the staff should have removed the excess water.”

“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: 34696 Based on observation and interview, the facility failed to implement and maintain a program to ensure that all equipment was maintained citing two of five areas (water treatment area and hemodialysis treatment area). Findings included: A review of the “Physical Environment” policy revision date 04/2018 included: “The dialysis facility will implement and maintain a program to verify that all equipment...are maintained...systems to assure patient safety will be in place.” On 11/15/2023, the following was observed: At 2:00 PM, it was observed in the water treatment area that the lid of the acid mixer was caked and splattered with dried acid concentrate. The Manager of Clinical Services (MCS, Personnel #2) said the staff was responsible for maintaining the water treatment area. At 2:05 PM, it was further observed in the water treatment area that a five gallon bucket of liquid, without a lid, sat in a corner behind the acid mixer. The MCS said bicarbonate was mixed in the bucket to neutralize the acid. Dried acid was observed on the floor around the bucket. At 2:15 PM, it was observed in the hemodialysis treatment area at stations #2, #5, #6, #7, and #12 had vinyl treatment chairs that had rips and tears in the head rest, arm rests, and seats that exposed the inside cushions. This did not allow for effective cleaning and disinfection. At the time of the findings, the Patient Care Technician (PCT, Personnel #9) said the chairs had been in disrepair for awhile. At 2:25 PM, the Group Facility Administrator (GFA, Personnel #1) said she was aware that the chairs were damaged.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 34696 Based on observation, record review, and interview, the facility failed to safeguard records against unauthorized use and keep confidential all information contained in patients’ records. Findings included: A review of the “Medical Records Custodian and Maintenance” policy revision date 10/2019 included: “The responsibilities of the custodian of the medical records include...verifies that all medical records are stored in a safe manner to protect against...unauthorized use.” On 11/15/2023 at 1:50 PM, 24 storage boxes were observed sitting in an unsecured, open space outside of the receptionist area. The Administrative Assistant (AA, Personnel #5) said the boxes were filled with patient’s records. She said the boxes had been sitting in the open space since 11/13/2023. Personnel #5 said the janitorial service goes to the facility daily. It was observed the medical records room had ample space and a locking mechanism on the door. On 11/15/2023, at the time of the findings, the Manager of Clinical Services (MCS, Personnel #2) said the boxes should have been stored in the medical records room.”