Davita Pace Road Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 46831 Based on facility policy review, observation, and interview, the facility failed to ensure adequate Infection control measures were taken to ensure patient safety and a clean and sanitary environment. The findings included: 1. The facility failed to ensure appropriate infection control measures were taken by allowing team members to wear artificial nails and failed to ensure supplies were discarded once opened. Refer to V-111 2. The facility failed to ensure staff members providing care to Positive Hepatitis B patients followed infection control guidelines and facility policy to lower the risk of spreading infection to non-positive Hepatitis B patients and staff. Refer to V-115 3. The facility failed to ensure infection control measures were taken to prevent potential cross contamination between patients by staff members. Refer to V-116 4. The facility failed to ensure dialysis machines and stations were adequately cleaned and disinfected between patients to prevent cross-contamination. Refer to V-122 5. The facility failed to ensure staff members providing care to Positive Hepatitis B patients followed infection control guidelines and facility policy in order to lower the risk of spreading infection to non-positive Hepatitis B patients and staff. Refer to V-128 6. The facility failed to dispose of medications that were expired and were readily available for use on the treatment floor. Refer to V-143 7. The facility failed to ensure measures to prevent CVC related infections were performed during CVC exit site care. Refer to V-147 8. The facility failed to dispose of supplies that were expired and were ensure they were readily available for use on the treatment floor Refer to V-401”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 46831 Based on facility policy, observation, and interview, the facility failed to ensure appropriate infection control measures were taken by allowing staff to 5 of 8 (CCHT #3, #4, #5, #6 and RN #1) team members providing patient care to wear artificial nails, failed to ensure supplies were discarded once opened on 1 of 2 (06/09/2025) observation days, and failed to ensure the barrier piece of tape was not used by 2 of 4 (CCHT #2 and #3) staff members on 1 of 2 observation days. The findings included: 1. Review of the facility policy “Principles of Aseptic Technique” revised 01/2020, revealed, “...Prevent organisms from being carried from place to place by air currents. Items which must be kept sterile should not be opened until ready for use because exposure to the air for long periods of time will contaminate them...” Review of the facility policy “Infection Control and Precautions for All Patients” revised 07/2023, revealed, “...Staff performing dialysis access care will not wear artificial nails and will maintain nails no longer than ¼ inch beyond the fingertip...” Review of the facility policy “Personal Appearance” revised 1/1/2025, revealed, “...Artificial nails including but not limited to tips, overlays, acrylics, wraps or other artificial attachments are not permitted...” 2. Observations on the treatment floor on 06/09/2025 at 9:34 AM, revealed CCHT #6 was wearing long, acrylic nails with pink tips and flowers. Observations on the treatment floor on 06/09/2025 at 9:42 AM, revealed CCHT #3 with long painted nails, dark in color. Observations on the treatment floor on 06/10/2025 at 1:23 PM, revealed CCHT #4 wearing clear and light pink acrylic painted nails. Observations on the treatment floor on 06/10/2025 at 1:30 PM, revealed CCHT #5 wearing long acrylic nails with blue nail tips. During an interview on 06/11/2025 at 9:32 AM, the FA stated artificial nails were not supposed to be worn nor should staff have long fingernails per facility policy. 3. Observation on the treatment floor at Station #18 on 06/09/2025 at 9:32 AM, revealed CCHT #3 used barrier tape on RP #11’s vascular access. Observation on the treatment floor at Station #3 on 06/09/2025 at 10:31 AM, revealed CCHT #2 used barrier tape on RP #12’s vascular access. During an interview on 06/11/2025 at 9:32 AM, the FA stated the barrier tape should not be used on the vascular access. 4. Observations on the treatment floor counter on 06/09/2025 revealed twenty-eight (28) 10 ml syringes found open to air with needles attached and prelabeled with 06/10/2025. During an interview on 06/09/2025 at 11:40 AM, RN #1 stated “It is not normal for me to do that.” 5. Observations of the medication station on 06/09/2025 revealed six (6) 1.0 ml syringes opened to draw up Epogen (Medication used to treat Anemia). During an interview on 06/09/2025 at 10:08 AM, RN #2 stated “they [syringes] come wrapped up, but I opened too many this AM so I left them.” 6. Observations on 06/09/2025 of the Blue cart on treatment floor revealed three (3) 1.0 ml syringe used to draw up Epogen opened at 11:34 AM and one (1) 3.0 ml syringe opened at 11:34 AM. During an interview on 06/09/2025 at 11:38 AM, RN #1 verified all of the above was opened. 7. Observations on 06/09/2025 at 9:59 AM of the storage Cabinet on the treatment floor revealed One (1) OptiFlux F160NRe Dialyzer (a membrae used to allow the removal of small and middle size moleculed from the blood) was found opened. During an interview on 06/11/2025 at 9:32 AM, the FA stated that dialyzers, syringes, or anything else should not be opened until time for use.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 49570 Based on facility policy review, observation, and interview, the facility failed to ensure staff members providing care to Positive Hepatitis B patients followed infection control guidelines and facility policy to lower the risk of spreading infection to non-positive Hepatitis B patients and staff during 1 of 1 (06/09/2025) observation days. The findings included: 1. Review of facility policy, “Use of Isolation for Hepatitis B Antigen Positive or Unknown Status Patients” revised 09/2020 revealed, “...To decrease the risk of contact between infectious sources (blood or body fluids of an infectious sources (blood or body fluids of an infectious patient or objects which may come in contact with patient’s blood or body fluids) and staff members, other patients and visitors within the dialysis facility...Infection Control: Infection control procedures must be strictly adhered to in the care of HBsAg positive patients...Don full PPE prior to entering the isolation room/area and wear at all times while providing care...” 2. Observations on the treatment floor outside of the isolation room at 9:40 AM revealed CCHT #3 providing care to Patient #2. CCHT #3 was observed donning PPE; however, CCHT #3 did not fully put on the isolation gown. It was not tied in the back nor fully draped over her shoulders. 3. During an interview on 06/11/2025 at 9:32 AM, the FA stated that PPE should be worn according to policy, which did include tying the gown and it being fully draped over shoulders.”

“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: 49570 Based on facility policy review, observation, and interview, the facility failed to ensure infection control measures were taken to prevent potential cross contamination between patients by 2 of 2 (CCHT #1 and CCHT #3) staff members observed during 1 of 2 (06/09/2025) observation days. The findings included: 1. Review of facility policy, “Infection Control and Precautions for All Patients” revised 07/2023 revealed, “...Supplies: Items taken into the dialysis station will 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...” 2. Observations on the treatment floor at Station #18 on 06/09/2025 at 9:32 AM revealed CCHT #3 used a thermometer on RP #11 and did not sanitize it before or after use. Observations on the treatment floor at Station #5 on 06/09/2025 at 11:03 AM revealed CCHT #1 used a thermometer on RP #13 and did not sanitize it before or after use. 3. During an interview on 06/11/2025 at 9:32 AM, the FA confirmed that electronic thermometers should always be cleaned after each patient use.”

“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: 49570 Based on facility policy, observation, and interview, the facility failed to ensure the hemodialysis station was adequately cleaned and disinfected between patient use by 1 of 3 (CCHT #1) staff members observed on the treatment floor during 1 of 2 (06/09/2025) observation days. The findings included: 1. Review of facility policy, “Infection Control and Precautions for All Patients” revised 07/2023 revealed, “...Cleaning and disinfection: Clean and disinfect the dialysis station (e.g., chairs, beds, tables, integrated keyboards, dialysis machines, ancillary equipment) after patient has vacated the station...” Review of facility policy, “Disinfection and Cleaning of Dialysis Machine Equipment” revised 07/2023 revealed, “...Clean all external surfaces of the dialysis machine to include top, sides, front and back, BP cuffs and basket; dialysate connectors and lines; hand sanitizer and holder; IV pole, items hanging on pole, attached computer monitors and keyboard/mouse...Disinfect all surfaces of the prime waste container, inside and out, with a moistened 1:100 bleach cloth...Clean counter tops behind patient station...Clean chair by placing in the reclining position and swing arms out (if applicable) to clean seat, footrest, backrest and sides, armrest, inside of chair arms and chair frame and side tray tables. Return chair to its upright position when cleaning is complete...” 2. Observations on the treatment floor at Station #5 on 06/09/2025 at 11:15 AM revealed CCHT #1 failed to wipe down the entirety of the patient chair, the entirety of the dialysis machine, and failed to clean the countertop behind the dialysis station when performing cleaning and disinfection of a dialysis station. 3. During an interview on 06/11/2025 at 9:32 AM, the FA verified that the chair, dialysis machine, and countertop should be completely wiped down with bleach after each patient treatment.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 49570 Based on facility policy review, observation, and interview, the facility failed to ensure staff members providing care to Positive Hepatitis B patients followed infection control guidelines and facility policy in order to lower the risk of spreading infection to non-positive Hepatitis B patients and staff. The findings included: 1. Review of facility policy, “Use of Isolation for Hepatitis B Antigen Positive or Unknown Status Patients” revised 09/2020 revealed, “...To decrease the risk of contact between infectious sources (blood or body fluids) of an infectious sources (blood or body fluids of an infectious patient or objects which may come in contact with patient’s blood or body fluids) and staff members, other patients and visitors within the dialysis facility...Infection Control: Infection control procedures must be strictly adhered to in the care of HBsAg positive patients...” 2. Observations on the treatment floor outside of the isolation room at 9:24 AM revealed the isolation room door was propped open while Patient #2, a positive Hepatitis B patient was receiving hemodialysis. CCHT #3 closed the door at 9:40 AM while entering to provide care to Patient #2. 3. During an interview on 06/11/2025 at 9:32 AM, the FA stated that the isolation room door should only be closed during initiation and discontinuation of hemodialysis 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: 46831 Based on facility policy, observation, and interview, the facility failed to ensure medications were labeled with initials, date, and time after being opened, failed to ensure medications were discarded before the expiration date, and ensure ports were cleaned before use for 1 of 2 (06/09/2025) observation days. The findings included: 1. Review of facility policy “Guidelines for Administration of Medication” revised 02/2025, revealed, “...Disinfect the rubber septum on the vial (single and multi-dose) with an alcohol wipe prior to each needle insertion...Any medications that are not immediately administered, will be labeled with the patient’s name, medication name, dose, date, time and preparer’s initial and will not be stored more than four (4) hours (or per stricter state regulations) prior to the anticipated administration time...” 2. Observations at the medication station on 06/09/2025 at 10:02 AM revealed the following unlabeled medications: Sodium Citrate (sodium salt of citric acid) 4% 1200mg/30mL containing Gentamicin (powerful antibiotic used to treat serious bacterial infections) injection 9.6 mg/30mL During an interview on 06/09/2025 at 10:10 AM, RN #1 stated “I opened it this morning and did not date it. Yes, it is supposed to be labeled.” Continued observations at the medication station revealed the following opened with no opened date, time or initials: One (1) vial Epogen (medication used to treat Anemia) 2 ml with no opened date, time, or initials present. Seven (7) 10 ml syringes pre-drawn with Heparin (medication used to prevent and treat blood clots by thinning the blood) with no initials or time present. During an interview on 06/09/2025 at 10:10 AM, RN #1 stated, “That is all [named] RN #2’s stuff...she drew them up. Mine are labeled.” During an interview on 06/11/2025 at 9:32 AM with the FA, he stated that vials and syringes should be labeled with date, time, and initials once opened or drawn up. He stated that syringes should only be opened when they are ready for use. 3. Observations on the treatment floor on 06/09/2025 at 10:12 AM, revealed RN #2 opened a vial of Venofer (an intravenous medication used to treat iron deficiency) 50 mg and did not clean the rubber stopper before injecting the syringe into the solution. Observation on the treatment floor on 06/09/2025 at 10:15 AM, revealed RN #2 went to RP #6’s dialysis station to administer the medication and did not wipe the port prior to injecting the syringe. During an interview on 06/11/2025 at 9:32 AM, the FA stated stoppers should be cleaned prior to injecting into and all ports should be cleaned prior to use.”

“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: 49570 Based on review of facility policy, medical record review, observation, and interview, the facility failed to ensure infection control measures were taken on 1 of 2 (06/06/2025) observation days when 2 of 2 (RN #1 and RN #2) nurses failed to clean the CVC exit site per facility policy and failed to follow MD orders regarding use of antibiotic ointment usage; the facility failed to ensure 1 of 2 (RN #1) nurses adequately cleaned the ends of the CVC between connecting and re-connecting syringes before initiating hemodialysis, and failed to ensure 3 of 3 (RN #1, RN #2, and RN #3) nurses changed out the under pad during the discontinuation of CVC hemodialysis on 2 of 2 (06/09/2025 and 06/10/2025) observation days. The findings included: 1. Review of facility policy, “Dialysis Catheter Dressing Change Procedure” revised 02/2023 revealed, “To provide guidance on performing dialysis catheter dressing changes to prevent infection which includes but is not limited to who can perform the dressing change, frequency, assessment of insertion site and procedure ...Using aseptic technique, cleanse the skin surrounding the exit site with the appropriate skin antiseptic ...Cleansing Agent ...ChloraPrep ...Povidone iodine ...ExSept ...NOTE: Antimicrobial ointment may be applied to catheter exit site with physician order only ...” Review of facility policy, “Accessing and De-Accessing the Dialysis Catheter” revised 06/2024 revealed, “Accessing: NOTE: Any time the catheter is disconnected ...clean the sides and end of hub thoroughly with friction ...De-Accessing ...replace underpad beneath catheter ...” 2. Review of the medical record for RP #1 revealed no MD order for the use of alcohol as a cleansing agent nor for the use of an antimicrobial ointment. Observations on the treatment floor at Station #19 on 06/09/2025 at 10:14 AM revealed RN #1 performing CVC exit site care on RP #1. RN #1 used an alcohol prep pad to cleanse the area around the CVC exit site instead of using an approved antiseptic listed in facility policy. RN #1 applied antimicrobial ointment (ointment used in the prevention of infections) to a 2 x 2 gauze before placing it on the site for the dressing change. Observations on the treatment floor at Station #19 on 06/09/2025 at 10:28 AM revealed RN #1 initiating hemodialysis on RP #1 via CVC. RN #1 initially cleaned the ends of the hub with an alcohol prep pad and then administered a flushing agent. RN #1 then unhooked the flushing agent and administered a blood thinning medication, followed by another flushing agent, and then the initiation of hemodialysis. RN #1 did not clean the ends of the CVC each time the hub was disconnected from a syringe and prior to administering medication or flush. Observations on the treatment floor at Station #7 on 06/09/2025 at 10:35 AM revealed RN #2 performing CVC exit site care on RP #2. RN #2 used an alcohol prep pad to cleanse the area around the CVC exit site. RN #2 failed to use an approved antiseptic listed on facility policy. Observations on the treatment floor at Station #9 on 06/09/2025 at 10:17 AM revealed RN #2 performing discontinuation of hemodialysis via CVC on RP #3. RN #2 failed to place a clean field [underpad] under the CVC ports, per facility policy. Observations on the treatment floor at Station #4 on 06/10/2025 at 10:40 AM revealed RN #1 performing discontinuation of hemodialysis via CVC on RP #4. RN #1 failed to place a clean field [underpad] under the CVC ports, per facility policy. Observations on the treatment floor at Station #7 on 06/10/2025 at 10:50 AM revealed RN #3 performing discontinuation of hemodialysis via CVC on RP #5. RN #3 failed to place a clean field [underpad] under the CVC ports, per facility policy. 3. During an interview on 06/11/2025 at 9:32 AM, the FA confirmed that facility policy should be followed for exit site care unless there is a specific MD order for the patient. He confirmed that anytime a CVC hub is open to air, the hub should be cleansed with alcohol and confirmed that a clean field should be placed under the CVC ports when discontinuing hemodialysis.”

“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: 46831 Based on facility policy review, observation, and interview, the facility failed to dispose of supplies that were expired and were readily available for use on the treatment floor for 1 of 2 observation days. The findings included: 1. Review of the facility policy, “Facility Space/Design and Safety Requirements” revised 04/2023, revealed, “...Ensure all supplies, medications, and testing strips are checked at least monthly for expiration...Expired items will be discarded appropriately prior to or day of expiration...” 2. Observations on the treatment floor on 06/09/2025 at 9:50 AM, revealed the following expired supplies: Storage Cabinet: 10:10 AM One (1) box of Betadine (Povidone-Iodine Prep Pad) (used for disinfecting skin and mucous membranes) with expiration date of 09/2024. During an interview on 06/09/2025 at 10:15 AM, RN #2 confirmed the box of Povidone-Iodine preps had an expiration date of 09/2024 and should be thrown away. Blue Cart: 11:34 AM One (1) First Aid Antiseptic (chemical solution applied topically to skin or wound to reduce the growth of harmful bacteria) with expiration date of 12/19/2014. One (1) AleveX pain spray (spray used for temporary relief of minor aches and pains of muscles and joints) with expiration date of 07/2023. One (1) Alcohol 91% 32 oz with expiration date of 06/2017. Nineteen (19) Betadine (Povidone-Iodine Prep Pad) with expiration date of 05/2024. During an interview on 06/09/2025 at 11:38 AM, RN #1 stated “Those are for my own personal use.” 3. During an interview on 06/11/2025 at 9:32 AM, the FA stated that expired supplies should be taken off the treatment floor and discarded.”

“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: 49570 Based on review of facility policy, observation, and interview, the facility failed to ensure appropriate measures were taken by 1 of 2 (CCHT #3) staff members to effectively evaluate access and prevent infection before cannulation of an AVF and/or AVG prior to initiation of hemodialysis on 1 of 2 (06/09/2025) observation days. The findings included: 1. Review of facility policy, “Assessment and Cannulation for AV Fistula/Graft and Patient Self Cannulation” revised 10/2023 revealed, “To provide guidelines for successful cannulation of new and existing arteriovenous fistulas and grafts ...Access preparation: Disinfect each access site separately with one of the below options: Alcohol Prep Pad, Utilize a rubbing motion for at least 30 seconds ...” 2. Observations on the treatment floor at Station #18 on 06/09/2025 at 9:32 AM revealed CCHT #3 initiating hemodialysis on RP #11 via an AVF/AVG. CCHT #3 failed to ensure appropriate disinfection of the access sites occurred by cleansing with an alcohol prep pad for 10 seconds and 7 seconds instead of 30 seconds on each site per facility policy. 3. During an interview on 06/11/2025 at 9:32 AM, the FA confirmed that AVG/AVG access sites should be cleaned with an alcohol pad for at least 30 seconds prior to cannulation.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 46831 Based on policy review, observation and interview, the facility failed to ensure visibility of hemodialysis access sites during treatment for 3 of 4 (Random Patient #8, #9, #10) patients observed during tour with their access covered for 1 of 2 observation days. The findings included: 1. Review of the facility policy “Intradialytic Monitoring of Patient” revised 07/2024, revealed, “...Ensure Patient’s Access, Blood Lines and Face are Visible at all times...During every 30-minute monitoring, the access and visualization of the face must be observed...Document patient refusal and charge nurse notifications in the flow sheet...Continued non-adherence will require additional intervention from the interdisciplinary team...” 2. Observations on 06/09/2025 at 3:33 PM revealed RP #8 receiving hemodialysis. The patient’s access site remained covered from 3:33 PM until 3:58 PM without staff interventions. This surveyor left the treatment floor at 3:58 PM and the site was still covered. 3. Observations on 06/09/2025 at 3:33 PM revealed RP #9 receiving hemodialysis. The patient’s access site remained covered from 3:33 PM until 3:58 PM without staff interventions. This surveyor left the treatment floor at 3:58 PM and the site was still covered. 4. Observations on 06/09/2025 at 3:33 PM revealed RP #10 receiving hemodialysis. The patient’s access site remained covered from 3:33 PM until 3:58 PM without staff interventions. This surveyor left the treatment floor at 3:58 PM and the site was still covered. 5. During an interview on 06/11/2025 at 9:32 AM, the FA stated hemodialysis accesses should be uncovered and able to be viewed by staff at all times.”