Davita Shelton Dialysis

“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: 44675 Based on observation, interview and review of facility policy, the facility failed to ensure the facility was maintained in a clean and sanitary manner in accordance with facility policy. The finding included: a. Observation conducted on 12/2/24 at 10:30 AM identified a sharps container located in the lab/soiled utility room with several dried blood droplets on top of the bucket, and on the adjacent wall. Interview with the Manager of Clinical Services on 12/2/24 at 10:35 AM identified that there should not be any dried blood splatter. Further observation on 12/3/24 at 2:45 PM and 12/4/24 at 10:30 AM identified the sharps container located in the lab/soiled utility room and adjacent wall remained. Observation on 12/4/24 at 10:30 AM identified the sharps container located in the lab/soiled utility room and adjacent wall were still not cleaned. Interview with the Manager of Clinical Services on 12/4/24 at 10:37 AM identified he/she had informed staff of the dried blood splatter in the lab/soiled utility room, but that they must have forgotten to clean it. b. Observations conducted on 12/3/24 at 11:45 AM identified stations #3, #7, #14, #20 and #11 were cleaned, disinfected and set up for a new patient treatment. There was white crusted splatter on the wallboxes (connections for the dialysis machine to concentrations, treated water and dispose of waste products), surrounding walls and machine lines. Interview and observation with Staff Person #2 on 12/3/24 at 11:50 AM identified she was the staff member who disinfected Station #20 after a patient hemodialysis treatment. She identified the hemodialysis machine was disinfected and set up for a new patient treatment, however, she did not clean the wallbox. She identified she did put hot water on the wallbox to help remove the crusted white buildup in the wallbox. Interview and observation with the Clinical Services Manager on 12/3/24 at 11:53 AM identified the wallbox did not appear to be clean due to the amount of dried white buildup. Subsequently, at 11:58 AM Staff Person #2 disinfected Station #20’s wallbox. c. Observations conducted on 12/4/24 at 10:00 AM identified stations #5 and #14 were cleaned, disinfected and set up for a new patient treatment. There was white crusted buildup on the wallboxes and machine lines. Station #11’s machine was not in use but had a large buildup of white crusted splatter on the wallbox. d. Observations conducted on 12/4/24 at 12:00 PM identified stations #1 - #3, #5 - #9 and #12 - #21 had patients on the machines currently treating. There was white crusted buildup on the wallboxes and machine lines. At station #9 there was an IDPN (intravenous nutrition administered during treatment) pole with IDPN connected to the patient’s hemodialysis machine. There was a rusted wrench taped on the top of the pump device with rust runoff on the pump. Interview and observations with the FA on 12/4/24 at 12:05 PM identified there should not be anything taped onto the medication pumps and subsequent to surveyor inquiry, the pump at Station #9 was cleaned. Review of the infection control policy directed at the end of each treatment, the dialysis station will be cleaned and disinfected. The wall box, drain and water supply lines are considered part of the dialysis delivery system. Teammates will monitor and address wall box residue/build up.”

“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: 44675 Based on observation, interview and review of facility policy the facility failed to ensure staff hand hygiene was performed per facility policy and for one (1) of five (5) patients reviewed for hand hygiene, the facility failed to ensure a patient was offered hand hygiene after holding their access sites. The findings included:. a. Observations conduced on 12/3/24 at 12:00 PM identified Staff Person #1 went to station #16, applied gloves without the benefit of hand hygiene before applying, conducted an assessment on the patient at station #16, then removed her gloves without the benefit of hand hygiene subsequent.. b. On 12/4/24 at 10:30 AM, Patient #10 was observed holding his/her hemodialysis access site with his/her gloved left hand. The patient removed the glove at 10:46 AM and did not perform hand hygiene, walked to the weigh station, weighed his/herself, then went to exit the clinic by grabbing the door knob with his/her left hand and was stopped prior to exiting and given hand sanitizer to clean his/her hands, however, the patient did not perform hand hygiene prior to coming into contact with the scale and the door knob. Interview with the Charge Nurse on 12/4/24 at 10:55 AM identified facility practice was to give hand sanitizer to patients who held their site(s) following treatment immediately after removing their glove and prior to going to the scale to weigh. Review of the Infection Control for Dialysis Facilities policy directed Review of the infection control for dialysis facilities policy directed that all teammates and physicians will perform hand hygiene prior to gloving and immediately after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual and before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. The policy further directed gloves should be changed when going from a “dirty” area or task to a “clean” area or task, after touching one patient or their dialysis delivery system, before arriving to care for another patient or touch another patient’s dialysis delivery system, and that patients will be encouraged to perform hand hygiene after treatment, before leaving the treatment area.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. 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 as 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 This Standard is not met as evidenced by: 44675 Based on observation, interview and review of facility policy for two (2) of six (6) patients (Patient #11 and #12) reviewed for catheter care, the facility failed to ensure staff and the patient donned personal protective equipment and performed Central Venous Catheter (CVC) care in accordance with facility policy. The findings included: 1. Patient #11 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and forty-five (45) minutes utilizing a CVC. Observations conducted on 12/4/24 at 10:28 AM identified Staff Person #3 disconnecting Patient #11’s CVC from both the arterial and venous blood lines at the end of his/her dialysis treatment, inserting heparin solution into each limb of the CVC, and applying end caps to each limb of the CVC while both Staff #3’s and Patient #11’s mask were only covering their mouths. Furthermore, Patient #11 was observed adjusting his/her mask at 10:32 AM, however had only maintained coverage of his/her mouth. Interview with the Clinical Coordinator identified both Patient #11’s and Staff Person #3’s mask should have been covering both their noses and mouths during the disconnection/termination of treatment process Review of the central venous catheter procedure directed to put on PPE and that the teammate and patient would wear masks covering their noses and mouths during the procedure. The policy further directed those measures are vital to preventing the exposure of the catheter and exit sit to nasal droplets and infectious bacteria such as MRSA. 2. Patient #12 was admitted to the facility with diagnoses that included end stage renal disease. Patient #12’s physician orders included hemodialysis treatment three times a week for three (3) hours and thirty (30) minutes with a left central venous catheter (CVC). Observations conducted on 12/3/24 at 11:37 AM identified Staff Person #1 at Station #5 for a treatment initiation. Staff Person #1 removed Patient #12’s catheter dressing, and without the benefit of hand hygiene, taped a new dressing over Patient #12’s catheter, without the benefit of hand hygiene, staff Person #1 proceeded to clean the catheter limb and hub. At 11:40 AM Staff Person #1 administered heparin via the catheter, treatment was then initiated at 11:42 AM without the benefit of letting the heparin anticoagulated for three (3) to five (5) minutes prior to initiation of treatment. Review of the central venous catheter procedure directed, in part, to perform hand hygiene, remove the old dressing and discard. Remove gloves, discard and perform hand hygiene per procedure and re-glove. Clean the exit site and clean each catheter limb/cap with a new large alcohol pad. Remove gloves, discard and perform hand hygiene. Review of the anticoagulation policy directed to anticoagulated the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the ventral venous catheter at least three (3) to five (5) minutes prior to the initiation of the hemodialysis treatment. 47491”

“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: 41746 Based on observation during a tour on 12/03/24 at 10:15 AM, while accompanied by the Facility Administrator, the Regional Bio-medical Technician, and the facility Bio-medical Technician, the surveyor observed that the facility failed to maintain a safe, functional and comfortable environment, the findings include the following: a) The floors throughout the treatment area were dirty, stained and ripped, not providing a sanitary and/or cleanable surface. b) The dirty sinks faucets on the treatment floor are rusted and pitting, not providing a cleanable surface. c) The trim around the drain and supply line for the eye-wash station in the treatment area are rusted and pitted, not providing a cleanable surface. d) The millwork at station #5 was broken, exposing raw wood, not providing a cleanable surface. e) The water treatment room floor was stained and separating at the seams, not providing a sanitary or cleanable surface. f) The return vents for the HVAC system throughout the facility were full of rust, not providing a safe and comfortable environment or a cleanable surface.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 41746 Observations on 12/03/24 at approximately 9:30 AM and during document review, the facility failed to maintain a building that was constructed and maintained to ensure the safety of the patients, the staff and the public. The findings include the following: a) On 12/03/24 at approximately 9:00 AM, and during document review Documentation was not provided to indicate that the fire drills were being conducted , as required by section # 21.7.1.6 of the “Life Safety Code”; i.e. there is no indication that fire drills were done in the 2nd quarter of 2024. b) On 12/03/24 at approximately 9:30 AM and during document review, the surveyors were not provided with documentation to show that the facility is maintaining the automatic sprinkler system in accordance with NFPA 25. Ie. 5 year obstruction test has been conducted as required by section # 5.1.1.2 of NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems”. Reports show no obstruction test done. c) On 12/03/24 at approximately 9:30 AM and during document review, the surveyor was not provided with documentation from the facility to indicate that a fuel sampling has been completed within the past year for diesel fired generators in accordance with Section 8.3.8 of the 2010 edition of NFPA 110.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for three (3) out of nine (9) hemodialysis patients reviewed for prescriptions (Patient #4, #6, and #7), the facility failed to ensure the patient’s hemodialysis treatment was in accordance with the physician orders. The findings include the following: 1. Patient #4 was admitted to the facility with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left central venous catheter (CVC), a dialysate flow rate (DFR) of 600 and blood flow rate (BFR) of 450. A sample review of Patient #4’s hemodialysis flowsheets identified on 11/12/24, 11/16/24, 11/19/24 and 11/30/24 the BFR was 400 with no rationale as to why the prescribed BFR of 450 was not met. Review of the nursing notes failed to identify documentation of why Patient #4’s hemodialysis prescribed BFR was not achieved. 2. Patient #6 was admitted to the facility with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times weekly for three hours and fifteen minute with a left arteriovenous fistula (AVF), DFR of 600 and BFR of 400. a) Review of Patient #6’s hemodialysis flowsheet dated 10/23/24 identified Patient #6’s catheter was accessed with no problems, however for the entirety of the treatment Patient #6’s BFR was 350 with no rationale as to why the prescribed BFR of 400 was not met. Review of the nursing notes failed to identify documentation of why Patient #6’s hemodialysis prescribed BFR was not achieved. b) Review of Patient #6’s hemodialysis flowsheet dated 10/28/24 identified for the entirety of the treatment Patient #6’s DFR was 400 with no rationale as to why the prescribed DFR of 600 was not met. Review of the nursing notes failed to identify documentation of why Patient #6’s hemodialysis prescribed DFR was not achieved. Review of the kt/v (adequacy of the hemodialysis treatment to be greater than or equal to 1.2) dated 10/28/24 identified Patient #6’s kt/v was .54 (inadequate). Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed, in part, if the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47491 Based on a review of clinical records, interview, and policy review for one (1) of five (5) hemodialysis patients reviewed for blood pressure (Patient #7), the facility failed to notify a registered nurse when the patient’s intradialytic blood pressure had decreased. The findings included: Patient #7 was admitted to the facility with diagnoses that included end stage renal disease. Patient #3’s physician order included hemodialysis treatment three (3) times weekly for three (3) hours with an upper left arm arteriovenous fistula (AVF). Review of Patient #7’s hemodialysis flowsheets identified on 11/11/24, Patient #7 had intradialytic blood pressures of 67/40 and 86/42 without documenting the registered nurse was informed or had assessed the patient. Interview with the Facility Administrator on 12/4/24 at 3:34 PM identified the registered nurse should be informed of systolic blood pressures of less than ninety (90) during treatment to assess the patient. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “abnormal findings” section in this policy). The policy directed an abnormal blood pressure finding would be a systolic less than 90 mm/HG.”

“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: 47491 Based on review of clinical records, and review of facility documentation and policy for one (1) of five (5) patients (Patient #7) reviewed for assessments, the facility failed to document a pre-treatment assessment in accordance with policy, for one (1) patient (Patient #5) reviewed for blood stream infections, the facility failed to notify the physician/nurse practitioner of a positive culture result, and failed to maintain daily glucometer calibration and refrigerator temperature logs. The findings included: 1. Patient #7 was admitted to the facility with diagnoses that included end stage renal disease. Patient #3’s physician order included hemodialysis treatment three (3) times weekly for three (3) hours with an upper left arm arteriovenous fistula (AVF). Review of Patient #7’s treatment sheet dated 11/18/24 identified treatment was initiated at 11:42 AM, however the patient’s pre-treatment assessment was not documented until 12:51 PM, one (1) hour and nine (9) minutes after treatment had started. Review of Patient #7’s treatment sheet dated 11/24/24 identified treatment was initiated at 11:47 AM, however the patient’s pre-treatment assessment was not documented until 1:52 PM, two (2) hours and five (5) minutes after treatment had started. Interview with the Facility Administrator on 12/4/24 at 3:36 PM identified nurses are to document pre-treatment assessments within one (1) hour of initiating treatment. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directs the prescription components of treatment as well as the nursing assessment are confirmed within one (1) hour of treatment initiation. 2. Patient #5 was admitted to the facility with diagnoses that included end stage renal disease. Patient #5’s physician order included hemodialysis treatment three times weekly for three (3) hours and thirty (30) minutes utilizing a central venous catheter (CVC). Review of Patient #5’s treatment record dated 2/1/23 identified a concern with CVC exit site/dressing. Review of a nurse’s noted dated 2/1/23 at 6:04 PM identified non-purulent drainage noted at the CVC and an order for a swab culture to be done to the catheter exit site. Review of the swab culture results dated 2/10/23 identified staphylococcus epidermidis and a sensitivities sheet indicating antibiotic treatment options. Review of nursing notes dated 2/10/23 at 3:25 PM failed to identify the physician/nurse practitioner was notified of the swab culture results, however identified the physician was notified of swelling and soreness that Patient #5 had in his/her right arm/shoulder and an order for blood cultures and follow-up with Access Center to evaluate for stenosis. Review of a nurse’s note dated 2/13/23 at 4:45 PM identified preliminary blood culture results of positive cocci in clusters in both aerobic and anaerobic culture bottles, notification of the nurse practitioner, and the instruction to send the patient to the hospital following treatment for evaluation and likely removal of the CVC. Review of Patient #5’s hospital discharge summary dated 2/18/23 identified removal and replacement of Patient #5’s CVC on 2/17/24 due to bacteremia growing Staphlococcus Epidermidis from the CVC. A physician’s order for 1250 mg vancomycin was administered to Patient #5 on 2/13/24 and 750 mg of vancomycin was administered each treatment following the patient’s return from the hospital until 3/20/23. Interview with the Facility Administrator on 12/4/24 at 10:15 AM identified the facility’s standard of practice was to monitor for results of a swab culture and review with the nurse practitioner once the results were received. The Facility Administrator further identified he/she was unable to determine if any discussion/documentation between the clinic and the physician/nurse practitioner had occurred regarding the swab culture results. Review of the Suspected Bloodstream Infection policy directed to obtain results from the blood culture, if applicable, and document in the electronic health record. The policy further directs to notify the nephrologist with results and sensitivities then to follow nephrologist orders as applicable. 3. Review of the Glucometer Calibration Log sheets identified missing entries dated 12/2/24, 11/25/24, 11/23/24, 11/15/24, 11/11/24, 11/9/24, 11/1/24, 10/30/24, 10/26/24, 10/25/24, 10/17/24, 10/12/24, 10/11/24, 10/7/24, 10/5/24, 10/4/24, and 10/3/24. Interview with the Facility Administrator on 12/4/24 at 3:38 PM that although policy directed to perform and document quality control procedures (testing and calibration of the glucometer) every day the monitor was used, best demonstrated practice was to calibrate the glucometer machine daily to ensure it was ready for use if needed. 4. Review of the Laboratory Refrigerator Log sheet identified missing entries dated 12/2/24, 11/25/24, 11/15/24, 11/11/24, 11/9/24, 11/1/24, 10/30/24, 10/26/24, 10/25/24, 10/17/24, 10/12/24, 10/11/24, 11/7/24, 10/5/24, 10/4/24, and 10/3/24. Interview with the Manager of Clinical Services on 12/2/24 at 10:35 AM identified glucometer callibrations and lab refrigerator temperature checks should be done on days of operation (days the facility is open, Monday through Saturday). Interview with the Facility Administrator on 12/4/24 at 3:40 PM identified the laboratory refrigerator temperature should be checked and documented daily when the facility was opened.”