Davita Shelbyville Road 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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure staff appropriately perform hand hygiene during 1 of 2 observations of initiation of dialysis and site care for patients with a central venous catheter (CVC). Findings included: A facility policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” revised in October 2023, indicated that the first step in the procedure was to “1. Perform hand hygiene per procedure. Put on PPE [personal protective equipment] and provide a mask to the patient.” The policy revealed, “4. Remove old dressing and discard. 5. Observe site for signs and symptoms of infection such as redness, drainage, swelling or tenderness. If present, report to RN [registered nurse]/physician. If drainage is present, obtain order for exit site culture. Observe CVC at exit site for evidence of cuff migration, cracks, of leaks in the catheter limbs. If present, do not initiate dialysis. Report to RN/physician for further follow-up. 6. Verify that both arterial and venous catheter limbs are clamped. 7. Remove gloves and discard. Perform hand hygiene per procedure and re-glove.” During an observation on 07/10/2024 at 10:49 AM, RN #5 was at patient treatment station #12 and donned gloves without performing hand hygiene and began CVC site care and treatment initiation procedures. RN #5 removed the patients old dressing and discarded it then began cleaning the exit site without changing gloves or performing hand hygiene. After applying a new dressing to the patients CVC exit site, the RN changed gloves without performing hand hygiene and continued the CVC treatment initiation procedure. During an interview on 07/10/2024 at 5:20 PM, RN #5 confirmed that hand hygiene was not performed in between all glove changes during CVC site care and dialysis initiation. RN #5 stated they felt a bit flustered because they had set up hand hygiene supplies in advance, but they had been moved. During an interview on 07/12/2024 at 11:28 AM, the Medical Director confirmed that hand hygiene should be performed between glove changes.”

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure staff disinfected, dedicated, or disposed of all equipment when removed from the patient treatment area by 3 (Registered Nurse [RN] #5, RN #4, and Patient Care Technician [PCT] #6) of 4 staff members observed providing patient care on 07/08/2024. Findings included: A facility policy titled, “Infection Control for Dialysis Facilities” revised in April 2023, revealed, “12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. [id est; that is] used or brought into the station) and prior to returning to clean/designated area or removal from treatment area.” The policy revealed, “15. The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas.” During an observation on 07/08/2024 at 3:11 PM, PCT #6 picked up a temporal thermometer from the clean computer workstation between patient treatment area #5 and patient treatment area #6 and brought it into patient treatment area #6 to take the temperature of the patient there. After taking the patient’s temperature, PCT #6 returned the thermometer to the clean computer workstation without disinfecting the thermometer. During an observation on 07/08/2024 at 3:22 PM, RN #5 picked up a temporal thermometer from the clean computer workstation between patient treatment area #10 and patient treatment area #11 and brought it into patient treatment area #11 to take the temperature of the patient there. After taking the patient’s temperature, RN #5 returned the thermometer to the clean computer workstation without disinfecting the thermometer. During an observation on 07/08/2024 at 4:23 PM, RN #4 picked up a temporal thermometer from the clean computer workstation between patient treatment area #3 and patient treatment area #4 and brought it into patient treatment area #3 to take the temperature of the patient there. After taking the patient’s temperature, RN #4 returned the thermometer to the clean computer workstation without disinfecting the thermometer. During an interview on 07/08/2024 at 5:11 PM, PCT #6 confirmed that the computer workstation was not considered part of the patient treatment area and that they used the temporal thermometer to take the temperature of the patient in patient treatment area #6 and returned it to the clean workstation afterwards, without disinfecting. During an interview on 07/08/2024 at 5:30 PM, RN #5 stated that she was unsure if the computer workstation was considered part of the patient treatment area. RN #5 confirmed that she used the temporal thermometer to take the temperature of the patient at patient treatment area #11 and did not disinfect the thermometer when returning to the workstation. RN #5 stated she was unsure whether the temporal thermometer needed to be disinfected after being taken from the patient treatment area. During an interview on 07/08/2024 at 5:45 PM, the Facility Administrator confirmed that the computer workstations were not part of the patient treatment area and were considered a clean area. During an interview on 07/12/2024 at 11:28 AM, the Medical Director confirmed that the expectation would be for items to be disinfected, dedicated, or disposed of when being removed from the patient treatment area.”

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure staff appropriately prepared parenteral medications prior to administration for 1 of 2 parenteral medication administrations observed. Findings included: A facility policy titled, “Preparation and Administration of Parenteral Medications (Non- ESA [erythropoiesis-stimulating agents], Non-Parsabiv)” revised in April 2024, revealed, “7. If the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad.” During an observation on 07/12/2024 at 8:40 AM, Registered Nurse (RN) #4 drew medication (Venofer) out of a single dose vial without first cleaning the vial stopper with alcohol. During an interview on 07/12/2024 at 8:47 AM, RN #4 confirmed that she did not clean the stopper of the single dose vial prior to drawing out the medication. RN #4 stated that she did not think she needed to clean the top of the vial since she opened the vial (removed the cap). During an interview on 07/12/2024 at 11:28 AM, the Medical Director confirmed that it was the expectation that all parenteral medication vial stoppers be cleaned with alcohol prior to drawing out the medication.”

“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: 50873 Based on interview, record review, and facility policy review, the facility failed to provide the necessary care and services to manage the patient’s volume status for 4 (Patients #1, #3, #4, and #6) of 5 patients in the medical record review sample. Findings included: A facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revised in April 2024, indicated, “2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). a. The assessment includes the following components:” “iii. Verification of prescription including machine parameters.” The policy revealed, “The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR [Ultra Filtration Rate; the rate of fluid volume removal during dialysis treatment] and Max UFR.” The policy revealed under the section titled “Intradialytic Data Collection/Assessment” that “a. Vital signs and treatment monitoring” included “iii. Non-nocturnal treatments are completed at least every thirty (30) minutes.” Patient #1’s “Treatment Details Report” dated 06/19/2024 revealed there was no evidence of vital sign monitoring from 7:04 AM to 8:12 AM (68 minutes) and 8:34 AM to 10:26 AM (112 minutes). Patient #1’s Treatment Details Report dated 06/24/2024 revealed there was no evidence of vital sign monitoring from 8:04 AM to 8:52 AM (48 minutes). Patient #1’s Treatment Details Report dated 07/01/2024 revealed there was no evidence of vital sign monitoring from 10:03 AM to 11:03 AM (60 minutes). Patient #1’s Treatment Details Report dated 07/08/2024 revealed there was no evidence of vital sign monitoring from 7:35 AM to 8:33 AM (58 minutes). During an interview on 07/11/2024 at 1:30 PM, the Facility Administrator confirmed the findings found in Patient #1’s medical record. Patient #3’s “Treatment Details Report” dated 06/19/2024 revealed there was no evidence of vital sign monitoring from 8:30 AM to 9:30 AM (60 minutes) and 9:30 AM to 10:30 AM (60 minutes). Patient #3’s “Orders 06/19/2024 - 07/08/2024” revealed an order with a start date of 03/30/2024 for maximum UFR of 15.0 milliliters (mL)/ kilograms (kg)/ hour (hr). Patient #3’s “Treatment Details Report” dated 06/19/2024 revealed staff documented the patient’s treatment UFR was 17.9 mL/kg/hr. Patient #3’s Treatment Details Report dated 06/21/2024 revealed staff documented the patient’s treatment UFR was 29.1 mL/kg/hr. Patient #3’s Treatment Details Report dated 06/28/2024 revealed staff documented the patient’s treatment UFR was 16.4 mL/kg/hr. During an interview on 07/11/2024 at 3:33 PM the Facility Administrator confirmed the findings found in Patient #3’s medical record. Patient #4’s “Treatment Details Report” dated 06/19/2024 revealed there was no evidence of vital sign monitoring from 6:13 AM to 7:33 AM (80 minutes), 8:10 AM to 9:00 AM (50 minutes), and 9:32 AM to 10:52 AM (80 minutes). Patient #4’s Treatment Details Report dated 07/08/2024 revealed there was no evidence of vital sign monitoring from 5:08 PM to 6:05 PM (57 minutes) and 7:06 PM to 8:05 PM (59 minutes). During an interview on 07/11/2024 at 5:22 PM, the Facility Administrator confirmed the findings found in Patient #4’s medical record. Patient #6’s “Orders 06/19/2024 - 07/08/2024” revealed an order dated 06/18/2024 for maximum UFR of 13.0 mL/kg/hr. Patient #6’s “Treatment Details Report” dated 06/19/2024 revealed staff documented the patient’s treatment UFR was 14.2 mL/kg/hr. Patient #6’s Treatment Details Report dated 06/24/2024 revealed staff documented the patient’s treatment UFR was 16.1 mL/kg/hr. During an interview on 07/11/2024 at 4:44 PM, the Facility Administrator confirmed the findings found in Patient #6’s medical record. During an interview on 07/12/2024 at 11:28 AM, the Medical Director confirmed that the expectation would be for patients to be monitored, including vital signs, at least every 30 minutes or more frequently per patient condition and for patient treatments to be run in such a way as to not exceed the ordered maximum UFR.”

“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: 50873 Based on interview, record review, and facility policy review, the facility failed to implement the adequacy plan for each patient for 4 (Patients #1, #2, #3, and #4) of 5 patients in the medical record review sample. Findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revised in April 2024, revealed, “2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). a. The assessment includes the following components:” “iii. Verification of prescription including machine parameters.” The policy revealed, “The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR [Ultra Filtration Rate; the rate of fluid volume removal during dialysis treatment] and Max UFR e. UF profiling f. Blood flow rate [BFR].” The policy revealed, “10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.” Patient #1’s “Orders 06/11/2024 - 07/11/2024” revealed an order with a start date of 06/26/2024 for a BFR of 350 millimeter (mL)/minute (min). Patient #1 “Treatment Details Report” dated 06/28/2024 revealed staff documented the patient ran at a BFR of 400 mL/min from 7:12 AM to 10:03 AM. Patient #1 Treatment Details Report dated 07/01/2024 revealed staff documented the patient ran at a BFR of 400 mL/min from 7:08 AM to 10:03 AM. Patient #1’s medical record revealed there was no evidence of documentation explaining the discrepancy between the ordered BFR and the BFR the patient was treated at. During an interview on 07/11/2024 at 1:30 PM, the Facility Administrator confirmed the findings found in Patient #1’s medical record. Patient #2’s “Orders 06/17/2024 - 07/11/2024” revealed an order with a start date of 06/11/2024 for a BFR of 450 mL/min. Further review revealed an order with a start date of 07/02/2024 for a BFR of 450 mL/min. Patient #2’s “Treatment Details Report” dated 06/17/2024 revealed staff documented the patient ran at a BFR of 300 mL/min from 1:35 PM to 4:14 PM. Patient #2’s Treatment Details Report dated 07/01/2024 revealed staff documented the patient ran at a BFR of 350 mL/min from 1:36 PM to 3:05 PM. Patient #2’s Treatment Details Report dated 07/05/2024 revealed staff documented the patient ran at a BFR of 400 mL/min from 3:32 PM to 5:00 PM. Patient #2’s medical record revealed there was no evidence of documentation explaining the discrepancy between the ordered BFR and the BFR the patient was treated at. During an interview on 07/11/2024 at 2:35 PM, the Facility Administrator confirmed the findings found in Patient #2’s medical record. Patient #3’s “Orders 06/19/2024 - 07/08/2024” revealed an order with a start dated of 03/30/2024 for a BFR of 450 mL/min. Patient #3’s “Treatment Details Report” dated 06/19/2024 revealed staff documented the patient ran at a BFR of 400 mL/min from 9:30 AM to 11:00 AM. Patient #3’s Treatment Details Report dated 06/21/2024 revealed staff documented the patient ran at a BFR of 350 mL/min from 9:00 AM to 10:00 AM Patient #3’s medical record revealed there was no evidence of documentation explaining the discrepancy between the ordered BFR and the BFR the patient was treated at. During an interview on 07/11/2024 at 3:33 PM, the Facility Administrator confirmed the findings found in Patient #3’s medical record. Patient #4’s “Orders 06/17/2024 - 07/08/2024” revealed an order dated 06/19/2024 for a BFR of 500 mL/min. Patient #4’s “Treatment Details Report” dated 07/05/2024 revealed staff documented the patient ran at a BFR of 600 mL/min from 1:15 PM to 5:30 PM. Patient #4’s medical record revealed there was no evidence of documentation explaining the discrepancy between the ordered BFR and the BFR the patient was treated at. During an interview on 07/11/2024 at 5:22 PM, the Facility Administrator confirmed the findings found in Patient #4’s medical record. During an interview on 07/12/2024 at 11:28 AM, the Medical Director confirmed that the expectation would be for the patient to be run at the ordered BFR or for there to be documentation of why the BFR the patient was run at differed from the ordered BFR.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to adequately respond to unusual or adverse patient events for 2 (Patient #1 and Patient #4) of 5 patients in the medical record review sample. Findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revised in April 2024, revealed, “17. Licensed nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP [non-physician practitioner] as applicable) is necessary prior to discharge of the patient from the facility.” The policy revealed under the section titled “Abnormal Findings” that “Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time.” Further review of the “Abnormal Findings” section of the policy revealed “Blood pressure: Pre-dialysis: Systolic [the top number of the blood pressure reading] greater than 180 mm/Hg [millimeters of mercury] or less than 90 mm/Hg. Diastolic [the bottom number of the blood pressure reading] greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” Patient #1’s “Treatment Details Report” dated 06/24/2024 revealed that at 10:34 AM, staff documented the patient had a blood pressure reading of 182/119 mmHg. Further review revealed there was no evidence of a nursing reassessment for symptoms related to the elevated blood pressure reading or provider notification of the elevated vital sign reading. The report revealed there was no evidence of the patient having as-needed (PRN; pro re nata) treatment orders in the event of elevated blood pressure readings (such as administering a PRN dose of an anti-hypertensive) or an order giving alternate provider notification parameters specific to this patient. Patient #1’s “Treatment Details Report” dated 07/03/2024 at 7:34 AM, revealed staff documented the patient had a blood pressure reading of 146/106 mmHg. Further review revealed there was no evidence of nurse notification of elevated diastolic blood pressure reading. Patient #1’s “Treatment Details Report” dated 07/05/2024, revealed there was no evidence of nurse notification of the following elevated blood pressure readings: -At 7:00 AM staff documented a blood pressure reading of 173/100 mmHg -At 7:03 AM staff documented a blood pressure reading of 183/99 mmHg -At 8:33 AM staff documented a blood pressure reading of 147/119 mmHg -At 9:03 AM staff documented a blood pressure reading of 135/101 mmHg Patient #1’s “Treatment Details Report” dated 07/08/2024 at 7:33 AM, revealed staff documented the patient had a blood pressure reading of 200/110 mmHg. Further review revealed there was no evidence of a nursing reassessment for symptoms related to the elevated blood pressure reading or provider notification of the elevated vital sign reading. The report revealed there was no evidence of the patient having PRN treatment orders in the event of elevated blood pressure readings or an order giving alternate provider notification parameters specific to this patient. During an interview on 07/11/2024 at 1:30 PM, the Facility Administrator confirmed the finding found in Patient #1’s medical record. The Facility Administrator confirmed that the expectation would be for the registered nurse (RN) to notify the provider of the elevated blood pressure reading. Patient #4’s “Treatment Details Report” dated 07/03/2024 revealed there was no evidence of nurse notification of the following elevated blood pressure readings: -At 6:33 AM staff documented a blood pressure reading of 186/129 mmHg -At 7:03 AM staff documented a blood pressure reading of 187/97 mmHg -At 7:34 AM staff documented a blood pressure reading of 193/110 mmHg -At 8:03 AM staff documented a blood pressure reading of 194/103 mmHg -At 8:33 AM staff documented a blood pressure reading of 183/111 mmHg -At 9:02 AM staff documented a blood pressure reading of 192/111 mmHg -At 9:33 AM staff documented a blood pressure reading of 193/96 mmHg -At 10:03 AM staff documented a blood pressure reading of 185/96 mmHg Further review revealed that at 10:40 AM, staff documented the patient’s blood pressure reading was 201/109 mmHg, with documented notification of the elevated reading to the nurse. The report revealed there was no evidence of a nursing reassessment for symptoms related to the elevated blood pressure reading, rechecking the blood pressure, or provider notification of the elevated vital sign reading. The report revealed there was no evidence of the patient having PRN treatment orders in the event of elevated blood pressure readings or an order giving alternate provider notification parameters specific to this patient. Patient #4’s “Treatment Details Report” dated 07/05/2024 revealed there was no evidence of nurse notification of the following elevated blood pressure readings: -At 1:16 PM staff documented a blood pressure reading of 184/115 mmHg -At 1:30 PM staff documented a blood pressure reading of 182/94 mmHg -At 2:00 PM staff documented a blood pressure reading of 184/113 mmHg -At 2:30 PM staff documented a blood pressure reading of 199/106 mmHg -At 3:00 PM staff documented a blood pressure reading of 186/104 mmHg -At 3:30 PM staff documented a blood pressure reading of 201/116 mmHg Further review revealed that at 4:05 PM, staff documented the patient’s blood pressure reading was 195/112 mmHg, with documented notification of the elevated reading to the nurse. The report revealed there was no evidence of a nursing reassessment for symptoms related to the elevated blood pressure reading, rechecking the blood pressure, or provider notification of the elevated vital sign reading. The report revealed there was no evidence of the patient having PRN treatment orders in the event of elevated blood pressure readings or an order giving alternate provider notification parameters specific to this patient. During an interview on 07/11/2024 at 5:22 PM, the Facility Administrator confirmed the findings found in Patient #4’s medical record. During an interview on 07/12/2024 at 11:28 AM, the Medical Director confirmed that the expectation would be that any nurse notification of out-of-range vital signs would be documented. The Medical Director stated if the patient did not have parameters specifying otherwise, the nurse should assess the patient, notify the provider, and document the assessment and provider notification along with any new orders received from the provider for patients with a blood pressure reading greater than 180 mmHg systolic or 100 mmHg diastolic. The Medical Director confirmed that was not a corporate policy but was decided individually by each clinic.”