Davita Sheffield 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: 47295 Based on observations, facility policy, and interviews, it was determined the facility failed to ensure staff followed the facility policy for hand hygiene. This affected one of two observations of Cleaning and Disinfection of the Dialysis Station, one of two observations of Access of Arteriovenous Fistula or Graft (AVF/AVG) for Initiation of Dialysis, and one of two observations of Discontinuation of Dialysis and Post Dialysis Access Care for AVF/AVG, and had the potential to negatively affect all 42 patients who dialyzed at this facility. Findings include: Facility Policy: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: April 2023 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...Hand Hygiene 1. All teammates, physicians, and non-physicians will perform hand hygiene (HH): ...b. prior to gloving and immediately after removal of gloves, ...g. before touching clean areas such as supplies... 2. Patients...will be encouraged to... ...b. Perform HH after treatment before leaving treatment area. 3. Use of an alcohol-based hand rub may be substituted for hand washing... 1. An observation of discontinuation of dialysis and post dialysis access care for AVF/AVG by Employee Identifier (EI) # 5, Licensed Practical Nurse (LPN), was conducted at station 2 on 1/30/24 at 10:15 AM for an unsampled patient. During the observation, the surveyor observed the patient holding his/her access site after needle removal with a gloved hand. At 10:52 AM, the patient removed the glove, exited the station to the scale, and exited the treatment floor without performing hand hygiene. Staff failed to remind/encourage patient compliance with hand hygiene after holding access sites, and glove removal, and prior to leaving the treatment floor. An interview was conducted on 2/1/24 at 9:15 AM with EI # 1, Facility Administrator (FA), who confirmed staff failed to encourage patient compliance with HH per policy. 2. An observation of cleaning and disinfection of the dialysis station by EI # 2, CCHT (Certified Clinical Hemodialysis Technician), was conducted at station 7 on 1/30/24 at 10:23 AM. During the observation, EI # 2 removed his/her gloves and without performing HH, donned clean gloves five times. 3. An observation of access of AVF/AVG for initiation of dialysis by EI # 2 was conducted at station 7 on 1/30/24 at 11:05 AM for Patient Identifier (PI) # 11. During the observation, EI # 2 palpated the AVF site with a gloved hand, removed gloves, and without performing HH opened a drawer and removed a tourniquet. EI # 2 then donned gloves, and without performing HH applied the tourniquet to PI # 11’s right arm and plapated the AVF site again. An interview was conducted on 2/1/24 at 9:15 AM with EI # 1, Facility Administrator, who confirmed EI # 2 failed to perform HH per policy. 41624”

“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: 41624 Based on observations, facility policy and interview, it was determined the staff failed to follow the facility policy for safe medication management and label all medications not immediately administered per policy. This affected one of two observations for dialysis supply management and contamination prevention, and had the potential to negatively affect all 42 patients who dialyzed at this facility. Findings include: Facility Policy: Medication Policy Policy Number: 1-06-01 Revision Date: October 2023 Purpose: To provide guidance for medication management in the facility... Policy: ...20. ...If the medication is not immediately administered...the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. 1. During observations of care on 1/30/24 at 3:30 PM, two filled three cc (cubic centimeter) syringes were observed being stored inside the Pharma Vac refrigerator located at the nurse’s station. Each syringe had a label which included the following: a. Patient name. b. Parsabiv (a medication utilized to reduce levels of parathyroid hormone) 2.5 mg (milligrams) c. Initials of teammate who prepared the dose d. Time 1439 (2:39 PM) The staff failed to document the date the medication was prepared on the label. An interview was conducted on 2/1/24 at 9:15 AM with Employee Identifier # 1, Facility Administrator, who confirmed staff failed to label the medication per facility policy.”

“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: 41624 Based on observations, facility policy and interview, it was determined the facility failed to ensure staff followed the facility policy for cleaning and disinfection of the dialysis station between patients in two of two observations of dialysis station disinfection. This had the potential to negatively affect all 42 patients who dialyzed at this facility. Findings include: Facility Policy Number: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis facility environment. Disinfection ...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings ...dialysis chair, tray tables....and frequently contacted by healthcare personnel ... 14. Non-disposable items are to be disinfected after each patient use... 1. An observation for cleaning and disinfection of the dialysis station was conducted on 1/30/24 at 10:58 AM at station 2 with Employee Identifier (EI) # 5, Licensed Practical Nurse. EI # 5 cleaned and disinfected one of the hooks on the IV (Intravenous) pole, but failed to clean and disinfect the three remaining hooks on the pole, and failed to clean and disinfect the laminated card and green emergency bag hanging on the pole. An interview was conducted on 2/1/24 at 9:15 AM with EI # 1, Facility Administrator, who confirmed the dialysis station was not cleaned/disinfected per facility policy. 47295 2. An observation for cleaning and disinfection of the dialysis station was conducted on 1/30/24 at 10:23 AM with EI # 2, CCHT (Certified Clinical Hemodialysis Technician) at Station 7. During the observation, EI # 2 failed to clean the counter behind the dialysis chair. An interview was conducted on 2/1/24 at 9:15 AM with EI # 1, who confirmed the dialysis station was not cleaned/disinfected per facility policy.”

“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: 41624 Based on observations, facility policy and interview, it was determined the facility failed to ensure Multi-dose vials (MDV) were labeled when opened per policy. This affected one of two observations for dialysis supply management and contamination prevention, and one of three observations for parenteral medication preparation and administration, and had the potential to negatively affect all 42 patients who dialyzed at this facility. Findings include: Facility Policy: Medication Policy Policy Number: 1-06-01 Revision Date: October 2023 Purpose: To provide guidance for medication management in the facility... Policy: ...29. Medications containing a preservative must be discarded 28 days after opening...Each vial is labeled with the initials of the person opening the vial and the expiration date. 1. During observations of care on 1/30/24 at 9:45 AM, a MDV of Heparin 30,000 units per 30 milliliters was observed opened at the medication preparation area. There was no opened date, initials of who opened the MDV, or expiration date written on the vial. Employee Identifier # 4, Registered Nurse (RN), confirmed at the time of the observation the MDV was opened and not labeled with his/her initials or an expiration date. 47295 2. During an observation of Parenteral Medication Preparation and Administration on 1/30/24 at 12:10 PM with EI # 4, he/she opened a new MDV of Heparin 30,000 units per 30 milliliters at the medication preparation area. EI # 4 did not write the date opened, expiration date, or initials on the vial and stated “I label it at the end of the day.” An interview was conducted on 2/1/24 at 10:15 AM with EI # 1, Facility Administrator, who confirmed EI # 4 did not follow the facility policy for labeling of MDVs.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 41624 Based on observations, facility procedure and interview, it was determined the facility failed to ensure staff performed Central Venous Catheter (CVC) care per facility policy. This affected one of two observations for CVC exit site care for an unsampled patient, and one of two observations for initiation of dialysis with a CVC for an unsampled patient, and had the potential to negatively affect all patients with CVC’s who dialyzed at the facility. Findings include: Facility Policy: Central Venous Catheter With Clearguard HD (Hemodialysis) Antimicrobial End Caps Procedure Procedure Number: 1-04-02B Revision Date: October 2023 Notes: ...Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines... Device Disinfectant and Skin Antiseptic 2% (percent) Chlorhexidine Gluconate 70% Isopropyl Alcohol (Chloroprep)...Effective for CVC access exit site...Effective Contact Time 30 seconds... 70% Alcohol pad...Effective for CVC Hubs....Effective Contact Time 15 second scrub... Procedure ...8. Holding catheter with the non-dominant hand and using aseptic technique, clean exit site with Chloroprep swab for a minimum of 30 seconds... ...16. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood.. 1. An observation was conducted on 1/30/24 at 12:07 PM at station 1 with Employee Identifier (EI) # 1, Facility Administrator (FA), to observe CVC exit site care for an unsampled patient. During the observation, EI # 1 performed antisepsis to the CVC exit site for 15 seconds utilizing a chloroprep swabstick. EI # 1 failed to perform antisepsis for 30 seconds per facility policy and procedure. An interview conducted on 2/1/24 at 9:15 AM with EI # 1 confirmed he/she failed to follow the facility procedure for CVC exit site care. 2. An observation was conducted on 1/30/24 at 12:12 PM at station 1 with EI # 1, to observe initiation of dialysis with a CVC for an unsampled patient. During the observation, EI # 1 scrubbed both CVC hubs with alcohol for 5 seconds each, failing to clean each hub for 15 seconds per policy. An interview conducted on 2/1/24 at 9:15 AM with EI # 1 confirmed he/she failed to follow the facility procedure for cleaning the CVC hubs.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 47295 Based on review of medical records (MR), facility policy and interviews, it was determined the facility failed to ensure staff followed the physician’s orders for Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR). This deficient practice affected two of five records reviewed and did affect Patient Identifier (PI) # 3, PI # 2, and one of four random observations conducted on the treatment floor for verification of dialysis treatment orders, and had the potential to negatively affect all 42 patients who dialyzed at this facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Policy Number: 1-03-08 Revision Date: 10/2023 Purpose: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment... Policy: ...3. Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment with the exception of BFR which is verified and documented when the ordered rate is obtained after onset of treatment... Intradialytic Data Collection/Assessment: ...9. ...b. At a minimum, obtain and document the following: ...iii. Blood and dialysate flows... ...10. If the dialysis prescription is not being met (including DFR or change to/inability to obtain prescribed BFR) the reason will be documented... 1. PI # 3 was admitted to the facility on 7/1/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the IDT (Interdisciplinary Team) Patient Profile Worksheet Treatment Orders dated 1/5/24 revealed PI # 3 had an ordered BFR rate of 400. Review of the TDR (Treatment Details Report) dated 1/16/24 revealed the BFR ran at 350 for the entire duration of treatment (9:02 AM to 12:38 PM). There was no documentation why the BFR was not at 400 as ordered. Review of the TDR dated 1/18/24 revealed the BFR ran at 350 for the entire duration of treatment (10:21 AM to 1:48 PM). There was no documentation why the BFR was not at 400 as ordered. Review of the TDR dated 1/20/24 revealed the BFR ran at 350 from 11:18 AM until treatment ended at 12:00 PM (42 minutes). There was no documentation why the BFR was not at 400 as ordered. An interview was conducted on 2/1/24 with EI (Employee Identifier) # 1, Facility Administrator, who confirmed the staff failed to follow the physician’s order for BFR. 41624 2. PI # 2 was admitted to the facility on 7/11/18 with a diagnosis of ESRD.. Review of the IDT Patient Profile Worksheet Treatment Orders dated 1/5/24 revealed PI # 2 had an ordered BFR of 350 ml/min (milliliters per minute). Review of the TDR dated 1/23/24 revealed the BFR ran at 450 from the start of treatment 10:47 AM until 11:15 AM. The BFR ran at 400 from 11:15 AM until the end of treatment at 1:46 PM. There was no reason documented why the BFR was not run at 350 as ordered. An interview was conducted on 2/1/24 at 9:05 AM with EI # 1 who confirmed the staff failed to follow policy and document why the BFR was not run at the ordered rate. 3. During observations on the treatment floor on 1/30/24 at 3:20 PM, the surveyor asked EI # 3, CCHT, to verify the current dialysis prescription order to compare it with the prescription currently being utilized for an unsampled patient receiving hemodialysis at station 3. EI # 3 stated the ordered DFR was 800 ml/min. The DFR at the time of the observation was 500, not 800 as ordered. EI # 3 confirmed at the time of the observation the DFR was not running at the ordered rate of 800. Review of the TDR dated 1/30/24 obtained by the surveyor on 1/31/24 revealed the DFR ran at 500 from the start of treatment at 12:40 PM until 1:09 PM. The DFR ran at 510 from 1:09 PM until 1:39 PM. The DFR ran at 500 from 1:39 PM until it was increased to 800 at 3:39 PM. There was no documentation on the 1/30/24 TDR why the DFR was not run at 800 as ordered. An interview was conducted on 2/1/24 at 10:30 AM with EI # 1 who confirmed the staff failed to follow policy and document why the DFR was not run at the ordered rate.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 41624 Based on observations, review of facility procedure and interview, it was determined the facility failed to ensure staff performed AVF/AVG (arteriovenous fistula/graft) site preparation per facility procedure in one of two observations conducted for AVF/AVG access and initiation of dialysis for an unsampled patient. This had the potential to negatively affect all patients who dialyzed with an AVF/AVG at this facility. Findings include: Facility Procedure Number: 1-04-01E Facility Procedure: AV (Arteriovenous) Fistula or Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose. Revision Date: October 2022 ...Materials required: 70 % alcohol preps ...Skin antiseptic... Notes: Check for patient sensitivity to preferred antiseptic/skin disinfectant listed in table below. Use Isopropyl Alcohol 70 % as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics. Notes: ...Skin Antiseptic Povidone Iodine...Effective Contact Time 30 seconds, Air Drying Time 2 minutes ...Isopropyl Alcohol 70 %...Effective Contact Time 60 seconds, Air Drying Time 15 seconds Procedure: ...10. While maintain(ing) aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic... 1. An observation of care for access of AVF/AVG for initiation of dialysis was conducted on 1/30/24 at 9:10 AM with Employee Identifier (EI) # 3, Certified Clinical Hemodialysis Technician (CCHT), at station 12 for an unsampled patient. Using two alcohol pads, EI # 3 performed antisepsis to each site of the AVF/AVG for five seconds with each pad, for a total of ten seconds with the alcohol pads, and after dry time, performed antisepsis using two povidone iodine pads for five seconds with each pad, for a total of ten seconds to each site. EI # 3 failed to perform antisepsis to each access site for the minimal effective contact time per facility procedure. An interview was conducted on 2/1/24 at 9:15 AM with EI # 1, Facility Administrator, who confirmed staff failed to perform access site antisepsis of the cannulation sites per facility procedure.”