Davita Plant City Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 34768 Based on observation, interview, and record review, the facility failed to follow infection control protocols related to donning and doffing gloves, hand sanitizing, and related to cleaning of the mechanical lift after usage. Findings included: An observation on 08/07/2024 at 9:25 a.m. of Staff A, Registered Nurse (RN) performing Central Venous Catheter (CVC) care for a patient at station 17. Staff A performed CVC dressing care. She cleaned both ports and withdrew blood into syringes and left them attached to the patient’s ports. She removed her gloves and reapplied gloves without hand sanitizing. Staff A removed one syringe with blood in it, cleaned the port, and flushed the port with saline. She then removed the second syringe with blood in it, cleaned the port, flushed it with saline and with a medication. She removed her gloves and replaced her gloves. She placed a syringe of medication into the dialysis machine. She removed her gloves and washed her hands with soap and water. She then touched her face, inputted into the computer and placed one glove on and opened a supply drawer with her ungloved hand and placed the supply on the drape. She then applied the second glove. She removed water from the dialysis machine to perform a test on the water. After performing the test she removed her gloves and hand sanitized and replaced one glove. She adjusted the dialysis machine, removed her single glove and inputted into the computer. She removed the thermometer from the computer stand and checked the patient’s temperature. She replaced her gloves, removed the blood pressure cuff from over the patient’s jacket, removed the patient’s jacket and replaced the blood pressure cuff on his sleeve. Staff A then touched the dialysis machine. She removed her gloves, hand sanitized, inputted into the computer and replaced her gloves. She touched the dialysis machine, removed her gloves and hand sanitized and replaced her gloves. She touched the dialysis machine, removed her gloves and inputted into the computer. She replaced her gloves, and touched the dialysis machine and connected the patient to the dialysis machine. Staff A put the patient’s legs up, touched the dialysis machine and removed her gloves and hand sanitized. An observation on 08/07/2024 at 10:00 a.m. of Staff D, Patient Care Technician (PCT) showed she hand sanitized, touched her face shield and applied her gloves. An observation on 08/06/2024 at 9:35 a.m. of Staff B, PCT and Staff C, RN during care of a patient at Station 16. Staff B and Staff C transferred the patient into a mechanical lift and transferred him into his wheelchair. The patient was wheeled to the scale by Staff B. Staff C replaced the mechanical lift into its holding area without cleaning it. Both staff members continued with their duties. During an interview with the Clinical Coordinator on 08/07/2024 at 10:00 a.m. she stated the expectation was for the staff to hand sanitize between glove changes. The staff was to hand sanitize after touching their face shields prior to applying gloves. The computer system was considered dirty, and the staff needed to hand sanitize before and after usage. She stated the mechanical lift was to be cleaned right after patient use, not at the end of the day. Review of the facility’s policy, “Infection Control for Dialysis Facilities,” revised April 2023 showed the purpose to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Hand Hygiene: 1. All teammates, Physicians and Non-physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment areas, b. prior to gloving and immediately after removal of gloves, d. after patient and dialysis deliver system contact, f. between patients even fi the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. PPE: 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-canulation or holding access sites. A. Gloves should be changed when: i. when soiled with blood, dialysate, or other body fluids. Ii. When going from a “dirty” area to task to a “clean” area or task, iii. When moving from a contaminated body site to a clean body site of the same patient. Disinfection: 12. Cleaning and / or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. 14. Non-disposable items to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient.”

“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: 49691 Based on observation, policy review, and interviews, the facility failed to follow facility policy and directions for use (DFU) of Dialysis machines in 23 of 23 dialysis machines reviewed. Findings Included: A review of the Direction for use for the facility’s dialysis machines, states: Disinfection 8.1 Procedure and disinfectants Machine disinfection system: The frequency of machine disinfection should be based on unit protocol while considering the allowable level of bacteria, endotoxin limits, and applicable regulatory requirements. At minimum, [manufacturer] recommends that the machine be disinfected once per day to disinfect and clean the fluid pathway. It is also necessary to disinfect the machine after a long out-of-operation time. A Disinfection can be performed with chemicals or with heat. A review of the facility policy titled: [Machine] System Cleaning and Disinfection Policy, showed that Thermal Disinfection should be completed each treatment day. A review of the last 8 months of facility disinfection logs was conducted. The subsection marked on the daily log as Integrated Heat (Thermal Disinfection) was blank on each day of operation and without initials or signatures. During an interview with Biomedical Technician, confirmed the integrated heat disinfection was not signed by staff and is part of the daily log requirements of the machines.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 34768 Based on interview and record review, the facility failed to ensure the Quality Assessment and Performance Improvement (QAPI) program continuously looked at indicators and trended outcomes and developed an improvement plan when indicated related to infection rates and adverse occurrences or “near misses.” Findings included: 1. During an interview on 08/07/2024 at 10:38 a.m. the Facility Administrator (FA), the Clinical Coordinator (CC), and two Manager Clinical Specialists (MCS) stated the current infection rate for July was 0.7% and the goal for the infection rate was 0.5%. The FA and CC stated they educated the staff and patients regarding infection control. The FA and the CC stated they put a plan into place. The FA and CC stated they went over the infection control policy and accesses including to look at the access for redness, heat to touch, etc., during a team meeting which occurred on 05/15/2024. They stated that 100% of the staff was present, it was a mandatory meeting. During the interview and review of the QAPI, it was revealed the patient which increased the infection rate to 0.7% had a positive blood culture and a fistula infection. It was documented as occurring on 06/19/2024. The FA and CC stated the plan was to educate the staff on the correct way to obtain blood cultures. The FA and CC stated they did not have formal education regarding infection control after the 06/19/2024 incident. The CC reviewed her “huddle” book and the only education she located was on hand washing and for the Patient Care Technicians (PCT) to observe for redness and report to the nurse so they can report to the physician. The CC stated they did not educate the staff on infection control related to accesses. The FA stated that the staff was educated on infection control on hire and as needed, at least once a quarter. The FA stated every month they go over something: hand hygiene, sanitation of the station, etc. The Monthly Infection Control audits are done monthly and reviewed monthly at the QAPI meetings. The FA and CC produced an in-service Training Documentation form dated 02/14/2024 that showed infection control was educated including checking for expired supplies, cleaning the station, hand hygiene to be performed after every glove removal and after touching the wall box, gloves not to be worn when using the computer. It was signed by all the staff employed on 02/14/2024. Review of the In-service Training Documentation form dated 02/14/2024 that showed infection control was educated including checking for expired supplies, cleaning the station, hand hygiene to be performed after every glove removal and after touching the wall box, gloves not to be worn when using the computer. It was signed by all the staff employed on 02/14/2024. 2. Review of Patient #8’s nursing note dated 06/12/2024 showed as a preventative safety measure, patient’s treatment was terminated prematurely with approval from NP, because the patient did not respond due to being very asleep and at the same time having involuntary movements, for which the AVF (arteriovenous fistula) was not functioning correctly with high AP (arterial pressure). We try to get some response from the patient, but she talks in a slurred manner, we can’t understand what she answers or says. The Blood pressure (BP) 53/39 was low and inaccurate. Also, she tried to get up from the chair several times. After rinsing the patient blood back, she keeps moving over and over, and the arterial needs comes off and the teammate was available to observe it before it became a bigger issue. No blood was lost. Patient refuses to go to ER. NP, FA aware. Review of the June 2024 FHR showed a “near miss” on 06/12/2024. As a preventative safety measure, patient’s treatment was terminated prematurely with approval from NP, as the patient did not respond due to being heavily self-medicated and not responding, had involuntary physical movements, tried to stand up numerous times from the dialysis chair causing tugging on the lines for which the AVF was not functioning correctly with high AP. RN and PCT tried to get a response from the patient, but she had slurred speech. During rinse back, the patient stood up again, causing the arterial needle to become dislodged and the PCT caring for the patient immediately noticed and took safety precautions before it became a bigger issue. No blood was lost. NP advised for the patient to go to the ER, patient requested for her family to take her to the hospital. Patient left with family. During an interview on 08/07/2024 at 10:38 a.m. the Facility Administrator (FA), the Clinical Coordinator (CC), and two Manager Clinical Specialists (MCS) stated they had a recent “near miss.” The FA stated they had a “near miss” when a patient became unresponsive during her treatment. She was completely out of it. She was delirious. She became responsive and started trying to pull out her lines. The FA stated she had taken a lot of medication at home before her treatment. She was an hour or two into her treatment. Staff C, RN was on duty that day as the charge nurse and Staff E, PCT was the technician involved. The FA stated Staff C, RN called the nurse practitioner (NP) and family of the patient. The NP ordered the treatment to stop, and the patient to be sent to the ER for evaluation. The incident was documented as a “near miss.” The FA stated both of these staff members were interviewed after the incident. The FA stated she followed up with the two team members regarding “observing patents during their treatments.” The FA stated she followed up with the family, and they did not take her to the ER. The FA stated the incident was listed as a “near miss.” The FA stated they did not do an action plan or educate the staff members regarding protocol. The MCS stated she did not follow up with Staff C, RN nor Staff E, PCT regarding the incident. The FA stated a root cause analysis was not performed regarding the incident. A plan was not put into place. The FA stated education was not provided to Staff C nor staff E by a senior nurse nor to the rest of the staff. The MCS stated they needed to perform a root-cause analysis to find out what and why the incident happened. The MCS stated there should have been education provided. The MCS stated they should track incidents over time, to ensure a major incident does not occur. The CC stated she was on vacation during the incident. The CC stated she was not aware of the incident until today. The CC stated she had not followed up with the nurse nor the PCT regarding the incident. Review of the facility’s policy, “Continuous Quality Improvement Program,” revised 2021, showed the Purpose: to improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in t4h CMA Conditions of Coverage. Policy: 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. Ther program must include, but not limited to, the following: Patient Safety, including “ Review of sentinel events o Review of trends of adverse patient occurrences including falls and blood loss “ Infection Control, including o Incidence of infections 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperforming, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 9. Each plan will be evaluated as to priority with Patient Safety and Clinical Outcomes indicators considered for the highest level of priority. Review of the facility’s policy, “Risk Event management Reporting,” dated July 2023 showed the purpose was to establish the process for handling and investigating Risk Event Management (REM) Reports. Policy: A. Preparing A Risk Event Management Report (Event Report) 1. Any unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event. Such risk events include, but are not limited to, personal injury or potential personal injury to a patient or third party, property damage, theft, equipment failure, flood or “near miss” events. 2. All risk events will be promptly reported to the Facility Administrator / Manager or designee. The teammate involved in the risk event or who witnessed the risk event firsthand will complete a Risk Event Management (REM) Report. The teammate will complete the Risk Event Management (REM) Report as soon after the occurrence as is reasonably possible, but no later than the completion of the teammates’ shift during which the risk event happened. B. Handling of the Risk Event Management (REM) Report to the Administrator / Manager or Designee: 3. Risk Event Management (REM) Reports are to be trended and reviewed during the Facility Health Meeting (FHM). This includes “Near Miss” events. Any negative trend should result in a plan of action. D. Investigation of the Risk Event Management (REM) Report by the MCS under the Direction of Risk and Litigation Unit: 1. The MCS will undertake investigations of Risk Event Management (REM) Reports at the direction of counsel. Such investigations may include, but are not limited to, risk events involving unexpected deaths, unexpected hospitalizations, and / or sentinel events. Sentinel events include suspected disinfectant infusion, suspected air embolism, suspected hemolysis, blood line separation, head injury, falls with fractures, burns, cardiac or respiratory arrest, suspected Hepatitis B exposure events and suspected pyrogenic reaction. The investigation will be conducted as soon as possible, but no later than thirty days of the occurrence. Exhibit A: Examples of Reportable Risk Events: Known or Suspected: “ Near Miss Events “ Unexpected Hospitalizations / ER”