Davita Dunmore Dialysis

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and documentation and based on interview with the registered nurse (RN-Employee #2) assigned to the Dialysis Services Den (DSD-hemodialysis services provided in a long-term care facility (LTCF)), the Regional Operations Director (ROD/Manager-Employee #10) assigned to the DSD and the facility administrator (Employee #9), the facility failed to ensure the one (1) of two (2) “Hazard Vulnerability Assessment” (HVA) forms were developed in accordance with facility policy/procedure. (HVA for the DSD) Findings include: On June 5, 2024 at approximately 11:17 AM, review of the DSD policy/procedure “Title: Facility Emergency Management Plan (DSD)” revealed the following under “Facility Hazard Vulnerability Assessment”: 1. The ROM (Regional Operations Manager), or designee, will coordinate with SNF (Skilled Nursing Facility-LTCF) leadership and the CCN (CMS Certification Number) Facility (Parent-Hub facility) to identify, evaluate and rate each hazard... On June 7, 2024 at approximately 9:04 AM, review of the facility policy titled “Facility Incident Management Tool” revealed strategies for the following were included in the Emergency Management Plan (EMP): -Cyber Security Event; and -Supply Chain Interruption. During interview conducted on June 5, 2024 at approximately 11:38 AM, the DSD RN (Employee #2) reported the emergency equipment cart for the DSD is the property of the LTCF and confirmed that the only emergency equipment cart located on the floor on which the DSD is located is shared with the LTCF. During interview conducted on June 5, 2024 at approximately 11:40 AM, a SNF staff member reported if there was a simultaneous medical emergency on the same floor on which the DSD is located, and the emergency cart was in use by the LTCF, a different emergency cart from another floor of the LTCF would be transferred to the DSD. On June 7, 2024 at approximately 9:04 AM, review of the CCN Facility (Parent-Hub facility) EMP revealed an in-center hemodialysis patient suffered cardiac arrest prior to the hemodialysis treatment on 01/24/2023. On June 5, 2024 at approximately 11:17 AM, review of the HVA for the DSD failed to reveal the following hazards were included in the emergency event review: -Care-Related Emergencies (Cardiac Arrest); -Cyber Security Event; and -Supply Chain Interruption. During interview conducted on June 7, 2024 at approximately 3:55 PM, the ROD and the facility administrator confirmed the HVA for the DSD did not include a review of the following emergency events/hazards: Care-related emergencies (cardiac arrest), cyber security event nor supply chain interruption.”

“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: 19122 Based on review of facility policy/procedure and observation, and based on interview with the Regional Operations Director (ROD/Manager-Employee #10) assigned to the Dialysis Services Den (DSD-hemodialysis services provided in a long-term care facility (LTCF)) and the facility administrator (Employee #9), the facility failed to ensure the one (1) of two (2) staff members assigned to the DSD performed hand hygiene in accordance with facility policy/procedure. (Employee #2) Findings include: On June 6, 2024 at approximately 10:35 AM, review of facility policy/procedure 1-05-01 titled ‘Infection Control for Dialysis Facilities” revealed the following under “Hand Hygiene”: 1. All teammates...will perform hand hygiene... b...immediately after removing gloves, d. after patient and dialysis system delivery contact... g. before touching clean areas such as supplies... On June 5, 2024, observation of patient care in the DSD revealed the following: 9:58 AM: After initiating the hemodialysis (HD) treatment and completing the dressing change for the central venous catheter (CVC-intravenous line utilized to administer dialysis) for the patient located at hemodialysis (HD) station #1, the registered nurse (RN-Employee #2), picked up the blood specimens obtained from the patient and removed a single glove which was discarded with the supplies utilized during the HD initiation process and CVC dressing change. Without removing the second glove nor performing hand hygiene, the RN proceeded to transport the computer cart to a different position on the treatment room floor. 12:55 PM: After inserting the access needles and initiating the hemodialysis (HD) treatment for the patient located at HD station #3, the RN (Employee #2) proceeded to discard the supplies and gloves utilized during the treatment initiation process but without performing hand hygiene, the RN proceeded to obtain clean laboratory supplies from a storage cabinet. During interview conducted on June 7, 2024 at approximately 3:55 PM, the ROD and the facility administrator confirmed the RN (Employee #2) failed to perform hand hygiene in accordance with facility policy/procedure.”

“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: 19122 Based on review of facility policy/procedure and observation, and based on interview with the facility administrator (Employee #9), the in-center hemodialysis (ICHD) facility failed to ensure dialysis supply management was conducted in accordance with facility policy/procedure by two (2) of two (2) ICHD staff members. (Employees #3 and #13) Findings include: On June 6, 2024 at approximately 10:35 AM, review of facility policy/procedure 1-05-01 titled ‘Infection Control for Dialysis Facilities” revealed the following under “Supplies”... 10...supplies...or medications...taken to the station should be used only for that patient and should not be returned to a common clean area or used on other patients. On June 4, 2024, observation of patient care in the ICHD facility at approximately 10:10 AM revealed the following: During the hemodialysis (HD) treatment initiation process, the patient care technician (PCT-Employee #3) transported a can of CryoDose Topical Anesthetic Spray (medicated spray designed to temporarily control pain associated with IV starts) from the common supply cart to HD station #13. After the PCT applied the medicated spray to the access site, the spray can remained uncapped on the HD chair tray while the PCT inserted the HD needles and connected the HD set (bloodlines). After completion of the treatment initiation process, the PCT replaced the cap on the spray can, disinfected the exterior of the can and then returned the can to the common supply cart which was contrary to the dialysis supply management requirements included in the above referenced policy/procedure. On June 7, 2024, observation of patient care in the ICHD facility at approximately 10:00 AM revealed the following: During the HD treatment initiation process, the registered nurse (RN-Employee #13) applied CryoDose Topical Anesthetic Spray to the access site of the patient located at HD station #3. After the RN applied the medicated spray to the access site, the spray can remained uncapped on the HD chair tray while the RN inserted the HD needles and connected the HD set (bloodlines). After completion of the treatment initiation process, the RN replaced the cap on the spray can, disinfected the exterior of the can and then returned the can to the common supply cart which was contrary to the dialysis supply management requirements included in the above referenced policy/procedure. During interview conducted on June 7, 2024 at approximately 3:55 PM, the facility administrator confirmed the above referenced ICHD staff failed to ensure dialysis supply management was conducted in accordance with facility policy/procedure.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and documentation and based on interview with the Regional Operations Director (ROD/Manager-Employee #10) assigned to the Dialysis Services Den (DSD-hemodialysis services provided in a long-term care facility (LTCF)) and the facility administrator (Employee #9), the facility failed to ensure total chlorine testing was conducted in accordance with facility policy/procedure for four (4) of four (4) months in 2024. (March, April, May and June 2024) Findings include: On June 6, 2024 at approximately 10:10 AM, review of facility policy 1-12-26, titled “DSD Total Chlorine Monitoring of Portable Osmosis (RO) Water Treatment Systems” revealed the following under “Policy”: 9. If the results of total chlorine testing from the primary carbon filter or set of tank/filters indicate a level of less than or equal to 0.1 ppm (part per million). Record results on the approved DaVita Water Treatment Safety Record in use at the SNF (skilled nursing facility-LTCF) program/facility which contains entries for the...date...test time...signature of person performing the test, test result and the signature of licensed nurse verifying that each test on the day log is complete and results are appropriate. Between June 5, 2024 at approximately 10:58 AM and June 6, 2024 at approximately 9:31 AM, review of the DSD “Water Treatment Safety Record (Prior to each treatment)” a single registered nurse (RN-Employee #2) performed and verified all total chlorine tests performed between March 1 and June 5, 2024 for portable RO’s #1, #2, #3, #4, #5, #6 and #7. There was no documentation on the DSD “Water Treatment Safety Record (Prior to each treatment)” which provided evidence two (2) DSD staff participated in the testing nor verification of the total chlorine results obtained between March 1 and June 5, 2024. During interview conducted on June 7, 2024 at approximately 3:55 PM, the ROD and the facility administrator confirmed there was no documentation which provided evidence two (2) DSD staff participated in the testing nor verification of the total chlorine results between March 1 and June 5, 2024 for the above referenced RO’s.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and documentation and based on interview with the biomedical technician (Employee #14) assigned to the Dialysis Services Den (DSD-hemodialysis services provided in a long-term care facility (LTCF)), the Regional Operations Director (ROD/Manager-Employee #10) assigned to the DSD and the facility administrator (Employee #9), the facility failed to ensure biomedical staff were notified three (3) of seven (7) portable reverse osmosis (RO’s) (water purification component of a dialysis water treatment system) failed to meet the minimum rejection rate of 90%. (Portable RO’s #3, #4 and #7) Findings include: On June 5, 2024 at approximately 12:55 PM, review of the DSD policy titled “EON Portable RO System Start Up Procedure” revealed the following: 7. Warning! The RO should not be placed into service until data on the daily water log sheet...meet the minimum standards set at your facility. On June 6, 2024 at approximately 10:11 AM, review of facility policy 1-12-25, titled “DSD Water Quality Monitoring of Portable Osmosis (RO) Water Treatment Systems” revealed the following under “Policy”: 3. Reverse Osmosis (RO) function is measured by: -Percent rejection value (minimum acceptable value is 90%). If percent ejection is less than 90%, contact your local biomedical specialist. During interview conducted on June 6, 2024 at approximately 10:26 AM, the biomedical technician reported that DSD staff provided notification on 05/20/2024 that portable RO’s had failed to attain a 90% rejection rate. Between June 5, 2024 at approximately 10:58 AM and June 6, 2024 at approximately 9:31 AM, review of the DSD “Water Treatment Safety Record (Prior to each treatment)” revealed the RO rejection was less than 90% on the following dates for the below listed portable RO machines: Portable RO #3 (03-10190609): 05/06, 05/08, 05/10 and 05/13/2024. Portable RO #4 (04-10192922): 04/22, 04/24, 04/26, 05/06, 05/08, 05/10, 05/13, 05/15 and 05/17/2024. Portable RO #7 (07-101932823): 04/24, 05/03, 05/06, 05/08, 05/10 and 05/13/2024. There was no documentation on the DSD “Water Treatment Safety Record (Prior to each treatment)” which provided evidence DSD staff notified biomedical staff prior to 05/20/2024 that the aforementioned RO’s failed to attain the 90% rejection rate on the above identified dates. During interview conducted on June 7, 2024 at approximately 3:55 PM, the ROD and the facility administrator confirmed there was no documentation which provided evidence DSD staff notified biomedical staff prior to 05/20/2024 that the aforementioned RO’s failed to attain the 90% rejection rate on the above identified dates.”

“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: 19122 Based on review of facility policy/procedure and medical records, and based on interview with the Regional Operations Director (ROD/Manager-Employee #10) assigned to the Dialysis Services Den (DSD-hemodialysis services provided in a long-term care facility (LTCF)) and the facility administrator (Employee #9), the facility failed to ensure the hemodialysis treatment was administered as per hemodialysis treatment orders for three (3) of four (4) patients who received HD services in the DSD. (Patient #1, #2 and #4) Findings include: On June 6, 2024 at approximately 10:15 AM, review of facility policy/procedure 1-03-081 titled “Treatment Initiation Utilizing B Braun Dialog+ Dialysis Delivery Systems With All Single Use Dialyzer Types and Streamline Bloodlines” revealed the following under “Procedures”: 2. Verify patient prescription. Prescription components include...Treatment time...UFR and Max UFR (ultrafiltration rate-rate of volume removal during dialysis)... Patient #1: On June 5, 2024 at approximately 1:15 PM, review of the DSD medical record revealed the hemodialysis (HD) treatment orders dated 05/06/2024 included the following: -Max UFR rate of 13 mg/kg/hr (milligrams per kilogram per hour). Review of hemodialysis treatment records revealed the UFR on 0520/2024 was 14.7 mg/kg/hr and on 05/27/2024 the UFR was 42 mg/kg/hr. There was no documentation in the medical record which provided evidence the UFR on 05/20/2024 and 05/27/2024 was in accordance with the above referenced HD treatment order. Patient #2: On June 6, 2024 at approximately 1:37 PM, review of the DSD medical record revealed the HD treatment orders dated 04/29/2024 included the following: -Max UFR rate of 13 mg/kg/hr (milligrams per kilogram per hour); -Treatment time: 180 minutes. Review of hemodialysis treatment records revealed the following: -The UFR on 0520/2024 was 18.6 mg/kg/hr, on 05/27/2024 the UFR was 30.7 mg/kg/hr and on 06/03/2024 the UFR was 13.4 mg/kg/hr; and -The treatment time on 05/22/2024 was 205 minutes and on 05/27/2024 the treatment time was 232 minutes. There was no documentation in the medical record which provided evidence the UFR and treatment time was administered in accordance with the above referenced HD treatment order on the above identified dates. Patient #4 (Discharge): Between June 5, 2024 at approximately 1:15 PM and June 6, 2024 at approximately 3:00 PM, review of the DSD medical record revealed the HD treatment orders dated 12/16/2023 included the following: -Max UFR rate of 13 mg/kg/hr (milligrams per kilogram per hour). Review of hemodialysis treatment records revealed the UFR on 01/08/2024 was 14.9 mg/kg/hr and on 01/10/2024 the UFR was 14.2 mg/kg/hr. There was no documentation in the medical record which provided evidence the UFR on 01/08/2024 and 01/10/2024 was in accordance with the above referenced HD treatment order. During interview conducted on June 7, 2024 at approximately 3:55 PM, the ROD and the facility administrator confirmed the UFR and/or treatment time was not in accordance the hemodialysis treatment orders for the above identified DSD patients on the above referenced dates.”