Rai Care Centers - Clearwater

“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: 20536 Based on observation, facility policies, staff education, and interviews the facility failed to 1. adhere to the standard of practice for hand hygiene in four (B, D, E, and F) out of 9 staff members; 2. Ensure disposable gloves were removed after patient care, and hand hygiene was done between patient contact in 5 of 7 observations; and 3. Ensure both hand washing sinks and wall mounted hand sanitizer stations had soap or product, during two of two days observed (5/13/2024, 5/14/2024). Findings included: 1. On 05/13/2024 at 9:39 AM Patent Care technician (PCT) staff D was observed donning gloves, then Staff D removed a patient Central Venous Catheter (CVC) (access used for hemodialysis) dressing. PCT Staff D cleaned the insertion site then applied a sterile dressing to the site with several missed opportunities for hand hygiene. PCT Staff D proceeded to clean the CVC ports and connect each port to the dialysis machine with several areas of missed opportunities for hand hygiene. On 05/132024 at 9:45 AM PCT Staff E was observed with gloves touching the computer at station 5 then touched Patient #7 and applied antiseptic to the left upper arm Arteriovenous(AV) fistula (surgical connection made between the artery and vein for dialysis treatments), PCT Staff E inserted the cannulated needles in the AV fistula. Several missed areas of opportunity for hand hygiene observed. On 05/13/2024 12:44 PM RN Staff B was observed with gloves touching the computer on station 1 then RN Staff B proceeded to remove one access port from the Patient 14’s AV fistula, noted bleeding RN Staff B applied pressure then placed a clamp on the patient arm, RN Staff B went to the computer to document before removing gloves and completing hand hygiene. On 05/13/2024 at 11:01 AM Nurse Practitioner Staff F was observed with gloves on assessing Patient 15, removed gloves with no hand hygiene noted. On 05/13/2024 at 11:17 AM Nurse Practitioner Staff F observed going into Patient 16’s personal bag without gloves and no hand hygiene noted. Nurse Practitioner Staff F then proceeded to Patient 17, wrapped a glove around index finger to touch the computer then put the glove into the trash with no hand hygiene observed. On 05/14/2024 at 7:15 AM PCT Staff D applied gloves and removed the CVC dressing from Patient 4, then PCT Staff D cleaned the insertion site and the dialysis hubs (end of the CVC that connects to the blood line or cap) and applied the syringes to the hubs, then withdrew blood into the syringe. PCT Staff D then applied a sterile dressing to the CVC site on the right chest of Patient #4. PCT Staff D then went to the computer/ dialysis machine and entered information into the computer, then cleaned the patients left upper extremity where Patient 4’s fistula is located and accessed the site with a dialysis needle. She then attached the dialysis machine to Patient 4’s CVC and fistula. Prior to exiting the room PCT Staff D removed her gloves then after exiting the room performed hand hygiene. Several missed areas of opportunity for hand hygiene observed. Review of the facility policy and procedure titled, “Hand Hygiene”, published 11/06/2023 revealed that all staff, patients. Patient care givers, including physicians and non-physicians practitioners, social workers, dietitians and any other indirect patient care staff must follow the same requirements for hand hygiene ...hands will be decontaminated using alcohol based hand rub or washing hands with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation ...immediately after removing gloves ... after contact with inanimate objects near the patient, and when moving from a contaminated body site to a clean body site of the same patient ... after contact with other objects within the patient station or treatment space ... Alcohol based hand rub dispensers should be: strategically placed throughout the facility ...at doors coming into and out of treatment area, technical area or staff lounge ...Sink Policy- a sufficient number of sinks with soap and plumbed with both hot and cold water shall be available to facilitate hand washing ... Review of the facility education on infection control training revealed that RN Staff B education was completed on 04/04/2024, PCT staff E education was completed on 10/19/2024 and PCT Staff D education was completed on 05/13/2024. An interview was conducted with PCT Staff E on 05/13/2024 at 9:50 AM. The surveyor inquired why the PCT Staff E did not remove her gloves and perform hand hygiene after accessing the cannulation site and inserting the cannulation needled and PCT Staff E said it is a waste of supplies and time to remove them constantly for the same patient and that she did not know that she had to do that. An interview was conducted with The Nurse Manager on 05/14/2024 at 8:21 AM inquired if she was aware of the infection control issues related to hand hygiene and the Nurse Manager stated that she is now aware and that they have a lot of traveler staff. Inquired if the traveler staff are employees of the company and was informed that they are. An interview was conducted with The Facility Administrator on 05/14/2024 at 8:21 AM. The Facility Administrator stated that the traveler staff is trained on the company’s Policy and Procedure for infection control. 2. Review of the policy for Fresenius Kidney Care Hand Hygiene policy 47664 Version 8 pages 1-6 Procedure for Decontaminating Hands, defines when to perform hand hygiene. Specifically noted after glove removal hand hygiene is to be immediately performed. On 05/13/2024 at 11:37 AM, an observation was performed of Staff A, Patient Care Technician, while caring for Patient # 9. Staff A removed gloves after cleaning Patient # 9’s Catheter insertion site, and donned another pair of gloves without performing hand hygiene between glove changes and placed a new dressing onto the patient’s catheter insertion site. On 5/13/2024 at 11:45 AM, observed Staff A, Patient Care Technician ,preparing to place Patient # 9 on dialysis. With gloves on, Staff A connected lumens to dialysis lines after cleaning the sites with alcohol, removed gloves and placed a new set of gloves on without performing hand hygiene in between doffing and donning new gloves. On 5/13/2024 at 11:18 AM, observed Staff A, Patient Care Technician, don gloves to discontinue Patient #10’s dialysis treatment. Patient #10 had an Arterial Venous Fistula. Staff A disconnected the arterial line after rinse back and disconnecting the venous line, removed her gloves. Went to obtain additional supplies i.e.: Clamps, gauze then came back to patient #10 donned new gloves and did not perform hand hygiene after doffing and donning. On 5/13/2024 @ 11:29 AM, observed Staff B Registered Nurse, don gloves to assist Patient #11 with removal of arterial needle of an Arterial Venous Fistula to place a clamp on the site, while giving Patient #11 an additional glove to hold Patient #11’s venous site. Staff B did not perform hand hygiene prior to donning gloves. When staff B removed gloves to obtain clean glove for the patient to hold their venous site, Staff B removed dirty gloves did not perform hand hygiene and obtained a glove for Patient #11. Hand hygiene was not performed. On 5/13/2024 @ 0950 AM, Observed Staff C Patient Care Technician ,while prepping a machine for an incoming treatment, check conductivity and pH from machine station 10, with gloves on, go to the Phoenix meter that is a multiuse conductivity meter, check the pH and Conductivity with the same gloves on, then go back to the Hemodialysis machine and note the conductivity and pH on the machine without changing gloves and without performing hand hygiene in between. 3. On 05/13/2024 at 9:34 AM, when entering the Patient Treatment Area from the employee hallway door, there was a “Lab” room with the door wide open. The room contained two hand washing sinks and one wall mounted paper towel dispenser. Both sinks were observed without any hand hygiene products to include either hand soap or hand sanitizer. There were no hand hygiene products in the room at all. Photographic evidence taken. Also, there were no staff in or around this Lab room. However, one of two sinks was observed with water pooling as if it were used. On 05/13/2024 at 9:38 AM between the “Lab” door wall and the employee hall door wall was observed with a wall mounted electronic hand sanitizer station. Surveyor tested the station and when hands were brought beneath the service spout, the electronic sensor did not trigger, therefore hand sanitizer product did not flow out. It appeared there was sufficient product in the bag within the machine. However, it appeared the batteries to the machine were not working. Photographic evidence taken. On 05/14/2024 at 10:30 AM an interview with the Clinical Care Manager, a Registered Nurse, as well as the facility’s Infection Preventionist, confirmed the wall mounted hand sanitizer station located at the exit door to the employee hall/office, and located near the lab entrance, was empty on 05/13/2024 and that the Biohazard Technician is the person who is responsible for maintaining the station’s batteries and replacing new bags of hand hygiene product. The Biohazard Technician was not available for interview on 5/14/2024. The Clinical Care Manager also confirmed the lab room had two sinks and the sinks are utilized for staff to wash their hands. She also confirmed that on 05/13/2024 there was no evidence of any bottles of hand soap, or hand soap at all for staff to wash their hands at either station. She confirmed the lab room in whole lacked hand soap or hand hygiene/sanitizer products for staff to utilize. On 05/14/2024 the Facility Administrator provided it’s “Hand Hygiene” policy and procedure with a published date 11/06/2023 for review. The policy revealed; Soap dispensers that use packaged soap packets may be used in facilities and refilled with prepackaged soap packets. If using individual hand pump soap bottles such as those meant for personal use, they will not be refilled and will be discarded when empty. The policy further revealed; Alcohol based hand rub dispensers should be: 1. Strategically placed throughout the facility, 2. Placed away from sinks to avoid any confusion between using soap and water and alcohol hand rub dispensers, 3. Installed on the side of each dialysis machine, 4. Place within reach of home patient training and treatment stations/spaces, 5. At doors coming into and out of the treatment area, technical area or staff lounge. The “Sink Policy” with a publish date 11/06/2023 revealed; A sufficient number of sinks with soap and plumbed with both hot and cold water shall be available to facilitate hand washing, Hand washing sinks should be dedicated for hand washing only and should remain clean.”

“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: 20536 Based on observation, policy review and interviews, the facility failed to: 1. Follow equipment maintenance per manufacturers DFU (Directions for Use); and 2. Failed to ensure patient care supplies/equipment were not expired. Findings included: 1. Review of the policy on 5/13/2024 of Fresenius Kidney Care: Biomedical Services DiaSafe Plus filter replacement and Integrity, Reference number 47413 Version 4 defines the policy for routine replacement and integrity of DiaSafe filters used in 2008T series Hemodialysis Machines. Under the policy manufacturers instruction for use states: The DiaSafe plus filters will be replaced in accordance to the manufacturer’s IFU (Instructions for Use). Review of Manufacturers Instruction for use regarding DiaSafe filter instructions form Fresenius medical care of North America, page 2; “Replace the DiaSafe filter at least every 90 days (3 Months). Review of Preventative maintenance logs provided by Biomedical personnel 2 of the 5 machines reviewed the DiaSafe Filters were not changed according to policy. Machine # 8 serial # 2TOS116405 and machine #14 Serial Number 2TOS116733 DiaSafe filters were not changed per policy and manufacturer IFU/DFU. In an interview with Biomed technician on 5/13/2024 at 1:45PM, when asked what the policy is for changing DiaSafe filters in the 2008T Hemodialysis machines, they stated; “We follow the policy of the manufacturer’s DFU/Direction for use.” 2. The storage closet was observed with the door open and with the room lights on. A rack of BD Vacutainer vials were noted on the shelves. The package of 100 was open with vials missing from the rack. Review of the expiration date on the front packaging revealed 12/23/2023. It was noted the vials were expired for almost 5 months. Photographic evidence was taken. On 5/14/2024 at 10:30 a.m. an interview with the Clinical Care Manager, confirmed the expired Vacutainer vials in the storage supply room and did not know why they were stored in that room. She explained that Vacutainer vials are stored in cabinets in the lab room. She also confirmed there were missing Vacutainer vials from the pack that were expired and could not be sure if tubes were used on or after 12/2023. She revealed it is the floor manager staff and her responsibility to go through the storage supply room and the lab room to look for expired supplies on a daily basis. She did not have documented evidence that showed this takes place on a daily basis.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 20536 Based on observation, facility documents, and interviews the facility failed to identify areas of opportunity for infection prevention in two of two days of observation. Findings included: On 05/13/2024 at 9:39 AM Patent Care technician (PCT) Staff D was observed to donning gloves then removing a patient Central Venous Catheter (CVC) (access used for hemodialysis) dressing. PCT Staff D cleaned the insertion site then applied a sterile dressing to the site with several missed opportunities for hand hygiene. PCT staff D proceeded to clean the CVC ports and connect each port to the dialysis machine with several areas of missed opportunities for hand hygiene. On 05/132024 at 9:45 AM PCT Staff E was observed with gloves touching the computer at station 5 then touched Patient #7 and applied antiseptic to the left upper arm Arteriovenous (AV) fistula (surgical connection made between the artery and vein for dialysis treatments). PCT Staff E inserted the cannulated needles in the AV fistula. Missed areas of opportunity for hand hygiene observed. On 05/13/2024 at 12:44 PM RN Staff B was observed with gloves touching the computer on station 1 then RN Staff B removed one access port from Patient 14’s AV fistula. Noting bleeding, RN Staff B applied pressure then placed a clamp on the patients arm. RN Staff B went to the computer to document before removing gloves and completing hand hygiene. On 05/13/2024 at 11:01 AM Nurse Practitioner Staff F was observed with gloves on assessing Patient 15. Staff F removed gloves with no hand hygiene noted. On 05/13/2024 at 11:17 AM Nurse Practitioner Staff F observed going into Patient 16’s personal bag without gloves and no hand hygiene noted. Nurse Practitioner Staff F then proceeded to Patient 17, wrapped a glove around index finger to touch the computer then put the glove into the trash with no hand hygiene observed. On 05/14/2024 at 7:15 AM PCT Staff D applied gloves and removed the CVC dressing from Patient 4. PCT Staff D cleaned the insertion site and the dialysis hubs (end of the CVC that connects to the blood line or cap) and applied the syringes to the hubs, then withdrew blood into the syringe. PCT Staff D then applied a sterile dressing to the CVC site on the right chest of Patient 4. PCT Staff D then went to the computer/ dialysis machine and entered information into the computer then proceeded to clean the patient’s left upper extremity where Patient 4’s fistula is located and then accessed the site with a dialysis needle. She then attached the dialysis machine to Patient 4’s CVC and fistula. Prior to exiting the room PCT Staff D removed her gloves then after exiting the room went to do hand hygiene. Several missed areas of opportunity for hand hygiene observed. Review of the facility infection surveillance platform documents from March 2023 to March 2024 revealed eight (8) cellulitis (a deep infection of the skin caused by bacteria) patients, two patients in December 2023, one patient in November 2023, one patient in October 2023, one patient in September 2023, one patient in July 2023, one patient in April 2023 and one patient in January 2023. Review of the facility meeting minutes revealed in December 2023 infection surveillance platform ...”goal met”; meeting minutes for November 2023 infection surveillance platform ... “goal met”. No infection for the month of November; September 2023 infection surveillance platform ... “goal met”: no infection for September. An interview was conducted with the Nurse Manager on 05/13/2024 at 12:22 PM. The Nurse Manager stated she thinks that she is the infection prevention nurse and Nurse Educator comes annually to educate on infection control. The Nurse Manager also said that the facility did not identify a trend with the staff not performing proper hand hygiene. A second interview was conducted with the Nurse Manager on 05/14/2024 at 8:21 AM. Inquired if she was aware of the infection control issues related to hand hygiene and the nurse manager stated that she is now aware and that they have a lot of traveler staff. Inquired if the traveler staff are employees of the company and was informed that they are. An interview was conducted with the Facility Administrator on 05/13/2024 at 2:30 PM. The Facility Administrator stated that he does not know where the cellulitis was located at on the report and would have to look in each patient medical record to determine if the cellulitis is at the dialysis access point. He stated that he did not have anything in place to prevent the spread of infection related to hand hygiene. A second interview was conducted with the Facility Administrator on 05/14/2024 at 8:43 AM. The Facility Administrator stated that he has no audits in place and no performance improvement in place.”