Davita Renaissance 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: 41624 Based on review of the Centers for Medicare and Medicaid Services (CMS) ESRD (End Stage Renal Disease) Core Survey Observations of Hemodialysis Care and Infection Control (IC) Practices, facility policy and procedure, observations, and interviews, it was determined the facility failed to ensure: 1. Staff changed gloves and performed hand hygiene after evaluation of the access in two of two observations of Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG) dialysis initiation. 2. Staff performed hand hygiene before donning clean gloves during one of two observations of CVC exit site care. 3. Staff performed hand hygiene before retrieving a glove from the box of clean gloves. 4. Staff performed hand hygiene upon removing gloves after performing pretreatment patient assessment and typing on the chairside computer. This did affect three patients including Patient Identifier (PI) # 9, PI # 13, and PI # 14, and had the potential to negatively affect the 54 patients dialyzing at the facility. Findings include: Facility Policy Title: Infection Control for Dialysis Facilities Policy: 1-05-01 Revision Date: April 2023 ...Policy: The...CDC (Centers for Disease Control) recommendations... will be followed... Hand Hygiene 1. All teammates...will perform hand hygiene. ...b. prior to gloving and immediately after removal of gloves, ...d. after patient care and dialysis delivery system contact, ...g. before touching clean areas such as supplies...and chairside keyboard/mouse... PPE (Personal Protective Equipment) ...gloves 7. Disposable gloves will be worn when...touching...equipment at the dialysis station... a. Gloves should be changed when: ...ii.... going from a dirty area or task to a clean area or task... ESRD Core Survey Version 1.6 Access of AVF or Graft for Initiation of Dialysis... ...Action ...Evaluate access: Locate/palpate cannulation sites Hand Hygiene (remove gloves, if worn); don clean gloves... Apply antiseptic to skin over cannulation sites... CVC Exit Site Care... ...Action ...Sterile dressing applied to CVC exit site... Remove gloves, hand hygiene 1. An observation of Access of an AVF/AVG for Initiation of Dialysis for PI # 9 was conducted on 12/2/24 at 11:50 AM with Employee Identifier (EI) # 3, Registered Nurse (RN), at station three. With gloves on, EI # 3 evaluated the access site using palpation, then proceeded to perform antisepsis over the cannulation sites wearing the same gloves. EI # 3 failed to perform hand hygiene and don clean gloves after access evaluation and before performing antisepsis. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1, Facility Administrator, who confirmed EI # 3 failed to follow the facility policy for hand hygiene, and CMS IC Practices. 2. An observation was conducted at station 2 on 12/2/24 at 12:01 PM of EI # 4, Patient Care Technician (PCT), access the AVF for PI # 13 . After locating and palpating the AVF, EI # 4 failed to remove his/her gloves, perform hand hygiene, and don new gloves before prepping the skin for cannulation. After the start of treatment for PI # 13, EI # 3, RN, entered station 2. Without performing hand hygiene, EI # 3 retrieved gloves from the clean glove box, and donned them. EI # 3 performed the pretreatment nursing assessment for PI # 13, then removed his/her gloves, and without performing hand hygiene began typing on the chairside computer. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 3. During observations on the treatment floor on 12/2/24 at 1:25 PM, the surveyor observed EI # 3 walk to station four, don one glove without performing hand hygiene, and silence the alarm on the dialysis machine. EI # 3 failed to perform hand hygiene before touching clean equipment in the dialysis station. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1 who confirmed EI # 3 failed to follow the facility policy for hand hygiene and gloving. 4. An observation of CVC Exit Site Care for PI # 14 was conducted on 12/3/24 at 8:15 AM with EI # 2, RN, at station six. After completing site care, EI # 2 removed his/her gloves and donned a new pair without performing hand hygiene. EI # 2 failed to perform hand hygiene and gloving per policy. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1 who confirmed EI # 2 failed to follow the facility policy for hand hygiene and gloving. 49894”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 41624 Based on observation, review of facility policy, and interview, it was determined the facility failed to ensure the staff cleaned and disinfected non disposable equipment before returning it to a common clean area or use on another patient. This had the potential to negatively affect the 54 patients served by this facility. Findings Include: Policy Title: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: April 2023 ...Disinfection ...14. Non-disposable items are to be disinfected after each patient use... a. Stethoscopes will be disinfected with alcohol prep pad.... 1. During observations of care on 12/3/24 at 8:15 AM, the surveyor observed Employee Identifier (EI) # 2, Registered Nurse, retrieve a stethoscope from the common clean area that had fabric covering its length of tubing. This fabric would prevent effective cleaning and disinfection of the stethoscope. EI # 2 took the stethoscope to station six to perform an assessment on an unsampled patient, and returned the stethoscope to the common clean area. EI # 2 failed to remove the fabric covering and failed to disinfect the stethoscope per policy before returning it to the common clean area. An interview was conducted on 12/4/24 at 11:30 AM with EI #1, Facility Administrator, who confirmed EI # 2 failed to follow policy and disinfect the stethoscope after use.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 41624 Based on observation, review of facility policy and interview, it was determined the facility failed to ensure all equipment used in the isolation room was designated and labeled for “isolation” only. This had the potential to affect all Hepatitis B susceptible patients and staff at the facility. Findings include: Facility Policy: Hepatitis B Surveillance, Vaccinations, Infection Control Measures and Isolation Guidance Policy Number: 1-05-02 Revision Date: April 2024 Purpose: To prevent the spread of hepatitis B infections in the dialysis setting. Policy: ...Infection Control Measures For Confirmed Positive or Suspected/Unknown Status ...18. Machine ...b. A designated dialysis machine...will be used for treatment in the isolation room... 19. Equipment/Supplies a. Dedicated ancillary supplies...will be used. b. Such supplies will be labeled “isolation” and will remain in the isolation room... 1. An observation of the isolation room, station one, was conducted on 12/2/24 at 1:00 PM. The following items/supplies were observed not labeled for isolation only: a. B Braun dialysis machine # 14. b. Large rolling biohazard/garbage container. c. One box each of small, medium and extra large gloves. d. One pack of yellow gowns. An interview was conducted on 12/4/24 at 11:30 AM with Employee Identifier #1, Facility Administrator, who confirmed the observations.”

“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 49894 Based on observations, review of facility policies, and staff interview, it was determined the facility failed to ensure: 1. Medications were discarded within 28 days after opening. 2. Staff disinfected the rubber septum of the medication vial each time prior to entering a multi-dose vial (MDV) with a new sterile syringe and needle. 3. All refrigerated medications were locked if not under supervision by a licensed teammate. This had the potential to negatively affect all patients receiving medications at the facility, and did affect Patient Identifier (PI) # 8, one of two observations of Parenteral Medication Preparation and Administration. Findings include: Facility Policy: Medication Policy Policy Number: 1-06-01 Revision Date: 10/23 Policy: ...8. All teammates administering medications must utilize aseptic technique. ...11. All refrigerated medications, for example Erythropoeitin Stimulating Agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by a licensed teammate or per state regulations. ...29. Medications...must be discarded 28 days after opening or accessed (e.g. needle punctured) Facility Policy Title: Infection Control for Dialysis Facilities Policy: 1-05-01 Revision Date: April 2023 ...Policy: The...CDC (Centers for Disease Control) recommendations... will be followed... CDC Injection Safety Information for Providers FAQs Regarding Safe Practices for Medical Injections. Revision Date: March 2011 Medication Preparation Questions; 1. How should I draw up medications? Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications ...and the rubber septum should be disinfected with alcohol prior to piercing it. 1. A Flash Tour was conducted on 12/2/24 at 11:15 AM. In the medication refrigerator located at the nurse’s station, there was a vial of Tubersol (Tuberculin Purified Protein Derivative) with an open date of 10/16/24. Employee Identifier (EI) # 5, Registered Nurse (RN) confirmed it was past the expiration date. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1, Facility Administrator, who confirmed staff failed to discard the medication per facility policy. 2. An observation of care was conducted on 12/2/24 at 1:05 PM with EI # 5 for intravenous (IV) Heparin preparation and administration from a MDV for PI # 8. EI # 5 disinfected the septum of the MDV with alcohol and withdrew 1800 units of Heparin utilizing a three cubic centimeter (cc) syringe. EI # 5 then proceeded to puncture the septum with a second three cc syringe and withdraw an additional 1800 units of Heparin without disinfecting the septum with alcohol. EI # 5 failed to follow aseptic technique and disinfect the septum of the MDV with alcohol each time prior to entering the vial. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1 who confirmed staff failed to follow aseptic technique when entering the MDV vial. 3. A tour of the Home Hemodialysis Training Room was conducted on 12/2/24 at 1:10 PM. The medication refrigerator containing ESA was unlocked and not under direct supervision by a licensed teammate. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1, who confirmed staff failed to lock the refrigerator per facility policy.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 41624 Based on medical record (MR) review, facility policy and interview, it was determined the facility failed to ensure: 1. The Patient Care Technician (PCT) notified the Registered Nurse (RN) of a patient’s elevated heart rate during dialysis treatment. 2. Staff obtained weights post dialysis treatment via the facility scale and documented the weights in the MR. 3. Staff rechecked elevated blood pressures during dialysis treatment. 4. Staff notified the physician of elevated blood pressures. 5. Staff administered medication for elevated blood pressure. This affected Patient Identifer (PI) # 2, PI # 4, and had the potential to affect all 54 patients who dialyze at this facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy Number: 1-03-08 Revision Date: April 2024 Policy: 1. Patient data will be obtained and documented by the PCT or a licensed nurse. a. Data collection includes... ii. Measurement of Blood Pressure (BP) iii. Heart or pulse rate iv. Patient weight... ...9. Intradialytic Data Collection/Assessment a. Vital signs and treatment monitoring ...iii. Non-nocturnal...are completed at least every 30 minutes. b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate 11. Abnormal findings...will be reported to the licensed nurse immediately... The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician of changes in patient status. Post Treatment Data Collection/Assessment 15. The PCT or licensed nurse will obtain and document basic data on each patient post treatment and compare to pre-dialysis findings. Abnormal Findings Unless other abnormal parameters are established...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s MR... Blood Pressure-Intradialytic: Systolic greater than 180 Diastolic greater than 100 Heart or Pulse Rate Pre/Intra/Post Less than 60 beats per minute or greater than 100 beats per minute... 1. PI # 2 was admitted to the facility on 8/3/2020 with a diagnosis of End Stage Renal Disease (ESRD). Review of the 11/15/24 Treatment Details Report (TDR) Intradialytic Vital Signs revealed PI # 2 began dialysis treatment at 1:32 PM with a heart rate (HR) of 80 beats per minute. Further review revealed the PCT documented PI # 2’s HR was 171 beats per minute at 2:02 PM. There was no documentation the PCT notified the licensed nurse of the elevated HR. The PCT failed to follow policy and notify the licensed nurse of the abnormal finding. An interview was conducted on 12/4/24 at 12:24 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the PCT failed to follow policy and notify the licensed nurse of the elevated HR. 49894 2. PI # 4 was admitted to the facility on 8/25/17 with a diagnosis of ESRD. Review of the Patient Summary Report revealed an order dated 11/13/24 for Hydralazine 50 milligrams as needed. Review of the TDR dated 11/15/24 revealed intradialytic BPs measuring 204/115, 206/123, 197/166, 187/124, and 171/155. There was no documentation of the blood pressure being rechecked for accuracy. There was no documentation by the RN the ordered Hydralazine was offered or administered, or the physician was notified of the elevated BP. Review of the TDR dated 11/18/24 revealed intradialytic BPs measuring 206/103, 202/110, 193/109, 212/111, 191/111, and 193/106. There was no documentation of the blood pressure being rechecked for accuracy. There was no documentation the RN offered or administered the ordered Hydralazine. Review of the TDR dated 11/22/24 revealed intradialytic BPs measuring 190/115, 137/104, 180/114, 202/120, and 194/124. There was no documentation of the BP being rechecked for accuracy. There was no documentation the RN offered or administered the ordered Hydralazine, or the physician was notified of the elevated BP. Review of the TDR dated 11/25/24 revealed intradialytic BPs measuring 182/110, 198/153, 197/105, and 205/108. There was no documentation of the BP being rechecked for accuracy. There was no documentation the RN offered or administered the ordered Hydralazine, or the physician was notified of the elevated BP. Review of the TDRs dated 11/15/24, 11/18/24, 11/22/24, and 11/25/24 (four of six TDRs reviewed) revealed the post weight was documented as calculated by the dialysis machine and not obtained by the PCT or licensed nurse post dialysis treatment. An interview was conducted on 12/4/24 at 1:05 PM with EI #1, who confirmed staff failed to recheck elevated blood pressure, offered or administered ordered medication for elevated blood pressure, or notified the physician of elevated blood pressures. EI # 1 also confirmed staff failed to obtain and document post weights per facility policy.”

“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: 41624 Based on medical record (MR) review, facility policies and interview, it was determined the facility failed to ensure: 1. Staff had patients sign an Early Treatment Termination Against Medical Advice (AMA) form. 2. Staff waited three to five minutes to initiate dialysis treatment after administering loading dose heparin. This had the potential to affect all 54 patients dialyzing at this facility, and did affect Patient Identifier (PI) # 13, PI # 4, and PI # 2. Findings include: Facility Policy: Prescribed Treatment Time Not Met Policy Number: 1-01-09 Revision Date: April 2024 Policy: 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment AMA form any time the patient requests to terminate their treatment earlier than the prescribed run time. ...5. If a patient refuses to sign the Early Termination of Treatment AMA form, the RN will document the patient’s refusal with the words “patient refused” in the patient signature box along with the date... Facility Policy: Anticoagulation Policy Number: 1-06-02 Revision Date: Sept 2024 ...14. To anticoagulate the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the Central Venous Catheter at least three to five minutes prior to the initiation of hemodialysis treatment. 1. An observation was conducted on 12/2/24 at 12:01 PM with Employee Identifier (EI) # 3, RN administering a loading dose of heparin to PI # 13. EI # 3 adminstered the heparin and then immediately connected the blood lines to the patient’s access and initiated treatment. PI # 13 failed to wait three to five minutes after administering heparin bolus to initiate treatment to allow for anticoagulation. An interview was conducted on 12/4/24 at 11:30 AM with EI # 1, Facility Administrator, who confirmed staff failed to wait three to five minutes for anticoagulation before initiating treatment per facility policy. 2. PI # 4 was admitted to the facility on 8/25/17 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Patient Summary Report (PSR) revealed Active Treatment Orders with a treatment time of three hours and thirty minutes and a start date of 11/1/24. Review of the Treatment Details Reports (TDR) dated 11/6/24 and 11/15/24 revealed the treatment time was not three hours and thirty minutes and there was no AMA form signed by the patient in the MR for the shortened treatments. An interview conducted on 12/4/24 at 1:05 PM with EI # 1 confirmed staff failed to obtain a signed AMA form for treatment times not as prescribed per facility policy. 3. PI # 2 was admitted to the facility on 11/6/2020 with a diagnosis of ESRD. Review of the Active Treatment Orders with start date 11/11/24 revealed PI # 2 had an ordered treatment time of three hours and 30 minutes (210 minutes). Review of the TDR dated 11/12/24, 11/16/24, 11/20/24, and 11/23/24 revealed PI # 2 had a treatment time less than 210 minutes as ordered, ranging from 40 minutes to 111 minutes. There was no Early Termination of Treatment AMA form in the MR for dates 11/12/24, 11/16/24, 11/20/24 or 11/23/24. An interview was conducted on 12/4/24 at 12:24 PM EI # 1 who confirmed there was no documentation an Early Termination of Treatment AMA form was completed for the dates PI # 2 did not dialyze the ordered treatment time. 49894”

“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 49894 Based on observations, review of facility policy, and staff interviews, it was determined the facility failed to ensure staff performed skin preparation before cannulation per facility policy in one of two observations of accessing an Arteriovenous Fistula/Graft (AVF/AVG). This affected Patient Identifier (PI) # 13 and had the potential to affect all patients dialyzing with an AVF/AVG at this facility. Findings include: Facility Procedure: AVF/AVG Cannulation with a Nipro or Medisystems Fistula Needle and Administration of Heparin Loading Dose Procedure Number: 1-04-01E Revision Date: 10/22 Skin Antiseptic: Povidone Iodine Effective Volume: At least one prep pad per site Effective Contact Time: 30 Seconds Air Drying Time: 2 minutes Skin Antiseptic: Isopropyl Alcohol 70 percent (%) Effective Volume: At least four prep pads per site Effective Contact Time: 60 seconds Air Drying Time: 15 seconds Procedure: ...11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. 1. An observation was conducted on 12/2/24 at 12:01 PM with Employee Identifier (EI) # 4, Patient Care Technician, accessing the AVF for PI # 13 at station 2. EI # 4 cleaned the arterial access with two Isopropyl Alcohol 70% prep pads for five seconds and allowed to dry for two seconds. EI # 4 then immediately applied Povidone Iodine for five seconds. EI # 4 then repeated the skin preparation on the venous access using the same technique. EI # 4 failed to follow the facility policy for cleaning the AVF/AVG prior to cannulation. An interview was conducted on 12/4/24 at 11:30 AM with EI #1, facility administrtor, who confirmed staff failed to perform skin preparation before cannulation per facility policy.”