Davita Renal Center of Hamilton

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 49828 Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure: 1) implementation of effective infection control practices for the care of a Clostridioides difficile (C. diff, inflammation of the colon caused by the bacteria Clostridium difficile resulting in diarrhea, abdominal pain and fever) patient to prevent cross contamination (V-112); 2) hand hygiene is performed in accordance with facility policy during the initiation of hemodialysis through an arteriovenous fistula (AVF, a type of vascular access used for hemodialysis)(V-113) and; 3) the threads and end hubs of central venous catheters (CVC, a type of access used for hemodialysis) are cleansed in accordance with facility policy prior to initiating hemodialysis (V-147). This failure resulted in an Immediate Jeopardy (IJ), posing serious risk of harm to the patients. Findings include: On 12/12/24 at 9:41 AM, an IJ was identified for the facility’s failure to ensure that C. diff precautions were followed in the care of a patient infected with C. diff. On 12/12/24 at 3:21 PM, the IJ template was presented to the Group Facility Administrator and the Facility Administrator (FA), and a removal plan was requested. On 12/13/24 at 10:42 AM, an acceptable Removal Plan was received. The facility implemented the following to address the IJ: a Governing Body meeting was held to develop, approve, and implement a Removal Plan; and clinical staff were re-educated on facility policy, “CLOSTRIDIOIDES DIFFICILE (C. diff) MANAGEMENT.” The IJ was removed on 12/13/24 at 11:40 AM, after the State Survey Agency verified the full implementation of the removal plan, and Condition Level non-compliance remains (V-112). Cross Reference: 494.30(a) - Ic-CDC MMWR 2001 494.30(a)(1) - Ic-Wear gloves/Hand Hygiene 494.30(a)(2) - Ic-Staff Education-Catheters/catheter Care”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 49828 Based on one of one observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure implementation of infection control measures to decrease the possible transmission of Clostridioides difficile (C. diff, inflammation of the colon caused by the bacteria Clostridium difficile resulting in diarrhea, abdominal pain and fever) between patients and staff. Findings include: On 12/11/24 at 10:52 AM, Staff (S) 12, a Registered Nurse (RN), escorted Patient (P) 5 into Station 9. P5 was noted to be on contact precautions for C. diff. S12 carried the patients’ belongings and placed them on the chase wall. S12 removed his/her gloves, and, without the benefit of washing his/her hands with soap and water first, donned (put on) new gloves. Without changing his/her gown first, S12 exited Station 9 and then entered Station 7. S12 made contact with another patient while he/she provided care to the patient, who was not on contact precautions. At 10:53 AM, S11, a Patient Care Technician (PCT), entered Station 9. S11 placed the re-useable blood pressure (BP) cuff that was attached to the hemodialysis machine onto P5’s arm. This was not the patient’s dedicated BP cuff, which is required by facility policy. S11 removed his/her gloves and rubbed hand sanitizer onto his/her hands before donning new gloves. S11, without first changing his/her gown, then entered Station 4 where he/she came in contact with the hemodialysis machine. During an interview on 12/11/24 at 10:55 AM, S11 stated he/she needed to use the patients’ dedicated BP cuff, use a different gown to treat P5, and that he/she should use soap and water after performing care on the patient with C. diff. At 11:05 AM, S12 returned to Station 9 with an intravenous (IV) pole that had a stethoscope hanging on it, and a clear bag with the patients initials on it. The bag contained a disposable BP cuff. S12 removed the blood pressure cuff that was on the patient and disposed of it into the trash receptacle. S12 placed the blood pressure cuff from the clear bag onto the patient. S12 then assisted P5 to the restroom. After the patient was in the restroom, S12 removed his/her gloves, rubbed hand sanitizer between his/her hands, and donned new gloves. S12 did wash his/her hands with soap and water in accordance with facility policy. Without the benefit of changing his/her gown first, S12 entered Station 4 and touched the hemodialysis machine and patient recliner chair. S12’s gown made contact with the hemodialysis chair in Station 4. During an interview at 11:10 AM, S12 stated he/she should change his/her gown and wash his/her hands with soap and water after contact with P5. Facility policy titled, “Clostridioides Difficile (C. diff) Management,” revised April 2024 stated, “... Gown: Separate long-sleeved garment that is removed and discarded after caring for the patient ... Supplies/equipment: Separate patient supplies, including stethoscope and blood pressure cuff; label for this patient only ... Hand hygiene: Handwashing with soap and water (for mechanical removal of spores) is the preferred hand hygiene method ...””

“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: 51227 Based on one of one observations of hand hygiene during the initiation of hemodialysis through an Arteriovenous Fistula (AVF, a type of vascular access used for hemodialysis), and review of facility documents, it was determined that the facility failed to ensure that the staff perform hand hygiene in accordance with facility policy. Findings include: On 12/11/24 at 9:40 AM, in Station 7, S12, a Registered Nurse (RN), initiated hemodialysis through an AVF. With gloved hands, S12 checked the patients blood pressure and touched the dialysis machine. S12 removed his/her gloves and donned (put on) a new pair of gloves. S12 did not perform hand hygiene before donning new gloves. S12 set up a clean field and placed two unopened fistula needles, alcohol pads on the patient recliner side table. S12 removed one of his/her gloves and then exited the station and went to the clean area by the nurses’ station. S12 made contact with the nurse station, retrieved gauze pads and removed other gloved hand. S12 did not remove his/her gloves and perform hand hygiene upon exiting the station. S12 returned to Station 7, donned new gloves and began the initiation of hemodialysis. S12 did not perform hand hygiene upon re-entering the station and changing his/her gloves. This was not in accordance with facility policy. Facility policy titled, “Infection Control for Dialysis Facilities,” revised April 2023, stated, “... Policy: ... Hand Hygiene 1. All teammates, ... will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, ... d. after patient and dialysis delivery system contact, ... f. between patients even if the contact is casual, ...””

“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: 50912 Based on one of two observations of the initiation of hemodialysis using a central venous catheter (CVC, a type of access used for hemodialysis), review of facility policy, and staff interview, it was determined the facility failed to ensure that the policy for the initiation of hemodialysis is implemented. Findings include: On 12/11/24 at 10:30 AM, in Station 12, Staff (S) 8, a Registered Nurse (RN), initiated hemodialysis on Patient (P) 11 through a CVC. S8 removed the red thread cap, scrubbed the threads and the end hub for three (3) seconds with an alcohol prep pad before he/she attached the blood line to the red limb. This was 12 seconds less than the 15 seconds required by facility policy. S8 proceeded to remove the blue thread cap and scrub the threads and end of the blue hub for three (3) seconds, before he/she attached the bloodline to the blue limb. This was 12 seconds less than the 15 seconds required by facility policy. During an interview at 10:40 AM, S8 explained that he/she should clean the thread, hubs, and end caps for 15 seconds before attaching to the bloodlines according to the facility policy. Facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure,” revised October 2024, stated, “... Procedure ... Perform a 15 seconds hub scrub of the CVC during the process of connecting or disconnecting from the bloodlines ... 70% Alcohol pad CVC limbs and caps, one large pad per CVC limb, effective contact time: 15 second scrub ...””

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 48966 Based on two of two observations of dialysate pH (potential of Hydrogen) tests, staff interview, and review of facility documents, it was determined that the facility failed to ensure that pH testing is completed in accordance with facility policy and manufacturer instructions for use (MIFU). Findings include: On 12/11/24 at 11:00 AM, Staff (S) 10, a Patient Care Technician (PCT), was observed at the designated counter area across from Station 3 with a cup of clear solution. S10 confirmed, he/she was testing the pH of the machine dialysate. S10 proceeded to take a strip out the RPC 0-14 Ph test strip bottle and dip the strip into the clear solution for five seconds. S10 then read the strip immediately comparing the test strip to the color chart on the bottle showing the pH was 7.0. During an interview at 11:02 AM, S10 stated that the pH test strip needs to be dipped into the dialysate solution for five seconds and read immediately. On 12/11/24 at 11:15 AM, S11, a PCT, stood at the designated counter area across from Station 3 with a cup of clear solution. S11 confirmed he/she was testing the pH of the machine dialysate. S11 proceeded to take a test strip out of the RPC 0-14 pH test strip bottle and dip the strip into the clear solution for five seconds. S11 waited 15 seconds before comparing the strip to the color chart on the bottle showing the pH was 7.0. During an interview at 11:17 AM, S11 stated that the pH test strip needs to be dipped into the dialysate solution for five seconds and wait 15 seconds before comparing the strip to the color chart on the bottle. During an interview at 11:24 AM, S3, the Biomedical Technician, when asked for the MIFU for the RPC 0-14 Ph test strips being used on the hemodialysis floor stated the staff is using the wrong Ph test strips. S3 explained the RPC E-Z Chek 6.8- 8.5 pH should be used when checking the pH of the hemodialysis machine dialysate. While the RPC 0-14 Ph test strips being used provide accurate results, the correct strips allow for a narrower pH range. S3 stated he/she uses these strips when testing the water after disinfection. Upon review of the MIFU for E-Z Chek 0-14 pH Test Strips, it was revealed that the facility staff was not performing pH checks with the correct strips and also not performing the testing according to the MIFU for either the RPC E-Z Chek 0-14 pH Test Strips or the RPC E-Z Chek 6.8-8.5 pH Test Strips. This was not in accordance with facility policy and can lead to inaccurate test results. A review of the RPC E-Z Chek 0-14 pH Test Strips instructions for use stated, “Indications for Use K1000-0104 E-Z Chek 0-14 pH Test Strips are indicated for use in testing the Ph of water used for preparing dialysate. There are no other indications for use. Directions ... 2) Dip the strip into the test solution until the color on the indicator pads no longer changes. 3) Remove the strip and compare it to the color chart on the bottle. 4) Match the strip as closely as possible to one of the color scales on the bottle. Read the pH listed above the matched colors. Colors that are between two scales indicate a pH that is between the two values for those scales ...” A review of the RPC E-Z Chek 6.8-8.5 pH Test Strips instructions for use stated, “Indications for Use: K1000-0117 E-Z Chek 6.8-8.5 pH Test Strips are indicated for use in the testing the pH of bicarbonate/acetate dialysate and bicarbonate concentrate. Directions for Use: Bicarbonate/Acetate Dialysate or Bicarbonate Concentrate: ... 3) Dip or wet test strip pads for one second with fresh solution to be tested. ... 5) Briskly shake off excess solution. Compare test results to color scale on the bottle within 5-10 seconds. ...” Facility policy titled, “Testing pH For Acetate Based Dialysate Using RPC E-Z Check K100-0117 6.8-8.5 Test Strips,” revised February 2024, stated, “... Procedure ... 2. Obtain dialysate sample using a disposable cup, then dip the strip into the solution for one (1) second ... 3. Remove the strip from the fluid and shake off excess dialysate. Within 5-10 seconds, compare the strip to the color chart on the bottle. 4. Match the strip as closely as possible to one of the color scales on the bottle and read the pH range listed above the matched color. 5. pH test results should be between 6.9-7.6. ...””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 33556 Based on observation of the hemodialysis treatment floor and support space, it was determined the facility failed to ensure that a defect free environment is maintained at all times. Findings include: During a tour conducted on 12/11/24 at 10:45 AM with Staff (S) 3, the Facility Bio-Medical Technician, the following was observed: The exterior wall at the front of the Treatment Floor exhibited discoloration and staining indicative of water infiltration at the base creating an uncleanable surface. Within the Medical Waste Room, the exhaust vent register was visibly dusty. The floor inside the Medical Waste Room had grime on the surface, particularly under the pallets. Station 9 was missing trim molding. This exposed the wood-like base, which is an uncleanable material. S3 confirmed the above findings upon discovery.”

“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: 33556 Based on observation of the hemodialysis treatment floor and support space, it was determined the facility failed to ensure that a safe environment is maintained for patients, staff, and the general public. Findings include: During a tour conducted on 12/11/24 at 10:45 AM with Staff (S) 3, the Biomedical Technician, the following was observed: Exterior Exit Door 3, located at the front of the Treatment Room, was found in disrepair. The door required extraordinary force to open, making it unusable for patients, and the door would not self-latch when allowed to close. The door separating the Main Storage Room from the Treatment Floor was propped open with corrugated boxes. The storage room is a hazardous environment which should be contained within a smoke tight enclosure at all times. Exterior Exit Door 4, located on the side of the Treatment Floor, was blocked by Intravenous (IV) poles in storage. This inhibited the exit doors use in the event of an emergency. The door was also structurally corroded at its bottom. The Medical Waste Storage Room door would not latch when closed. Unprotected wall penetrations were found in the Main Storage Room. There was no visible fireproof protection for BX electrical cabling and mechanical piping exiting/entering from the adjacent electrical and water treatment rooms. S3 confirmed the above findings upon discovery.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 50912 Based on one of one observation of central venous catheter (CVC, a type of access used for hemodialysis) care, review of facility policy, and staff interview it was determined that the facility failed to ensure visual privacy is maintained during CVC care. Findings include: On 12/11/24 at 10:30 AM, in Station 12, Staff (S) 8, Interim Charge Nurse, pulled the privacy curtains located on each side of the station to ensure Patient (P) 11’s privacy on the left and right side of the patient. S8 did not pull a privacy curtain at the chase wall behind the dialysis chair in Station 12. This allowed staff and patients in Stations 5, 6, and 7 on the treatment floor to have a direct view of P11’s care. S8 proceeded to expose P11’s right upper chest wall in order to complete CVC exit site care and initiation of hemodialysis treatment. This is not in accordance with facility policy. During an interview at 10:41 AM, S8 stated, “Oh, I need to see the clock hanging on the wall on the other side of the station, so I did not close the curtains on the half back wall”. During an interview at 12:37 PM, S2, the Nurse Manager, confirmed that all the privacy curtains located in the station should be fully closed during CVC care. Facility policy titled, “Patient Rights,” last revised October 2021, stated, “Your Rights As A Patient: ... 4. The right to privacy and confidentiality in all aspects of treatment. The dialysis facility will make accommodations for ... privacy when patients are examined or body exposed ... with privacy screens or curtains ...””

“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: 51227 Based on one of one observations of the initiation of hemodialysis through an Arteriovenous Fistula (AVF, a type of vascular access used for hemodialysis), staff interview, and review of facility policy, it was determined that the facility failed to ensure that the staff perform skin disinfection of the access site prior to initiating the dialysis treatment in accordance with facility policy. Findings include: On 12/11/24 at 9:40 AM, in Station 7, Staff (S) 12, a Registered Nurse (RN), initiated hemodialysis through an AVF. S12 cleansed the first site of the AVF with povidone iodine in a circular motion for 13 seconds. This was 17 seconds less than required per facility policy. S12 then cleaned the second site with povidone iodine for eight (8) seconds. This was 22 seconds less than required per facility policy. S12 allowed both sites to dry then inserted the fistula needles. During an interview at 10:30 AM, S12 stated that each site must be cleansed with betadine (povidone iodine) for 30 seconds. Facility policy titled, “AV Fistula or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” revised October 2022, stated, “Skin Antiseptic ... Povidone Iodine ... Effective Contact Time ... 30 seconds ...””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51227 Based on one of one observation of medication administration, staff interview, and review of facility policy, it was determined that the facility failed to ensure the policy for the administration of heparin is implemented. Findings include: On 12/11/24 at 09:40 AM, in Station 7, the following was observed after cannulation (the process of inserting dialysis needles into a patient’s vascular access to allow blood flow to and from a dialysis machine) of an Arteriovenous Fistula (AVF, a type of vascular access used for hemodialysis). Staff (S) 12, a Registered Nurse (RN), attached a pre-filled heparin (blood thinner) syringe to the venous access line and slowly injected the heparin with a back-and-forth motion. Following the administration of heparin, S12 initiated the dialysis treatment after one minute. This was two minutes less than required by facility policy. During an interview at 10:30 AM, S12 stated that after administering heparin, the wait time to initiate dialysis is three to five minutes. S12 confirmed, he/she did not wait the proper amount of time. Facility policy and procedure titled, “AV Fistula Or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) And Administration Of Heparin Loading Dose,” revised in October 2022, stated, “... 29. Do not initiate dialysis for a minimum of three (3) to five (5) minutes after administering heparin loading dose. ...””