Davita Tucson South Central Dialysis

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 37489 Based on review of the facility’s Emergency Preparedness Testing Requirements, record review and staff interview, it was determined the facility failed to participate in drills as required. Failure to participate in drills may lead to untrained staff in an emergency situation and may result in harm to the residents during an emergency. Findings include: Document review on 11/06/2024 revealed that the facility was missing documents proving participation in a full-scale exercise (FSE) that was community-based or a facility based exercise or table top drills for the year 2023. The administrator confirmed during the exit interview that the facility was not able to locate proof of participation in either a full-scale exercise that was community-based or a facility based exercise in 2023.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure a visitor wore appropriate PPE while on the treatment floor which has the potential risk of exposure and spread of potentially infectious materials. Findings include: The facility policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” requires: “...PURPOSE...To minimize the spread of infections and bloodborne pathogens in the dialysis facility environment...PPE...Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area....” Observation on 11/06/2024 revealed a visitor assisting a patient into the dialysis chair at station #13. The visitor had to help transfer the patient who arrived in a wheelchair and needed Hoyer lift assistance. A staff member offered the visitor a gown after the patient had been transferred into the chair. The visitor continued to handle the patient’s belongings, take the patient’s wheelchair to the scale to be weighed, and manipulated the television and other items within the dialysis station with the front of the gown left unbuttoned and completely open. Employees #1 and 30 confirmed on 11/06/2024 that the visitor on the treatment floor was not gowned initially upon arrival on the floor, nor did the visitor correctly don and close the gown down the front as required for the remainder of the observation.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure staff aseptically cannulated (1) of (2) patients’ vascular access (Patient #11) prior to initiation of dialysis. Failure to adhere to infection control procedures prior to cannulation poses an increased risk of blood stream and vascular access infection as bacteria at cannulation sites may not be reduced. Findings include: The facility policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” requires: “...Skin Antiseptic...Hypochlorite (ExSept Plus)...Use at least two (2) sterile gauze for each site...Effective Contact Time 60 seconds...Air Drying Time 2 minutes...While maintain [Sic]...aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site using a circular rubbing motion, center out...removes skin oil and debris from the skin surface only. This is not skin antisepsis for cannulation...While maintaining aseptic technique, cleanse the site by applying skin antiseptic (ExSept Plus) using a circular rubbing motion from the center out and allow to dry. (For contact and dry time refer to the table above)....” Observation on 11/06/2024 revealed Employee #14 preparing and disinfecting Patient #11’s vascular access for cannulation. Employee #14 did not use an alcohol prep pad to pre-clean each site prior to applying the ExSept skin disinfectant. Employee #14 used ExSept soaked gauze to disinfect both the arterial and venous cannulation sites together for 17 seconds, then a second ExSept soaked gauze to disinfect the arterial and venous cannulation sites together for an additional 18 seconds. Employee #14 then waited 1 minute and 10 seconds to cannulate the arterial site, then the venous site was cannulated immediately after the arterial needle was placed. Employees #1 and 30 confirmed on 11/06/2024 that Employee #14 did not prepare and disinfect Patient #11’s vascular access prior to cannulation as required by 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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. staff labeled two (2) multi-dose Tubersol vials when opened; and 2. staff labeled one (1) multi-dose Heparin vial and legibly labeled two (2) multi-dose Heparin vials when opened. Findings include: 1. and 2. The facility policy titled “Medication Policy” requires: “...Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer...Each vial is labeled with the initials of the person opening the vial and the expiration date...Disposal of expired medications....are removed from the treatment and inventory areas and disposed of per state/local regulations....” 1. Observation on 11/05//2024 revealed two (2) open, multidose vials of Tubersol purified protein derivative. The vials were not labeled with an open or discard date. Employee #6 confirmed on 11/05/2024 that two (2) open vials of Tubersol were not labeled with an expiration date as required by facility policy to determine when the contents were expired and the vials should be discarded. 2. Observation on 11/05/2024 revealed two (2) illegibly dated, open vials of Heparin in Workstation B medication lock boxes and one (1) undated, open vial of Heparin in a Workstation A medication lock box. Employee #9 confirmed on 11/05/2024 that the workstation A medication lock box contained an unlabeled, open vial of Heparin Sodium. Employee #7 confirmed on 11/05/2024 that workstation B medication lock boxes contained two illegibly labeled, open vials of Heparin Sodium that the expiration date could not be deciphered and read to determine the expiration date and when to discard the vials.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications in the treatment area were locked and secured to prevent unauthorized access. Failure to secure medications when not in use may result in unauthorized access to medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered. Findings include: The facility policy titled “Medication Policy” requires: “... Non-refrigerated medications are to be stored in cabinets(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations....” Observation on 11/06/2024 revealed two workstations (Workstation A and B) on the dialysis treatment floor used by the dialysis technicians to provide for patient care. There were two lockboxes at each workstation that contained Heparin Sodium 30 mL vials and pre-drawn heparin syringes for patient administration. Two lockboxes with Heparin vials and pre-drawn syringes at Workstation B were unlocked and unsupervised. One lockbox that contained Heparin vials and pre-drawn syringes at Workstation A was found unlocked and unsupervised. Employee #1 confirmed on 11/06/2024 that (3) of the (4) medication lockboxes were found unlocked and unsecured when not in use as required by facility policy.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure: 1. the glucometer was calibrated with High/Low controls daily; and 2. the medication refrigerator temperature was monitored and recorded twice daily and logs were completed in their entirety. Failure to calibrate equipment and ensure it is functioning correctly has the potential risk of malfunction or inaccurate results from testing and/or complications from medications that have been stored inappropriately. Findings include: 1. Review of the facility glucometer logs revealed the following days that glucometer was not calibrated with the appropriate low and high control solutions to determine if the unit and strips were functioning together correctly. 02/13/2024 02/24/2024 05/01/2024 05/10/2024 05/27/2024 Employee #1 and 31 confirmed on 11/05/2024 that staff did not document calibration of the low/high controls for the glucometer on the aforementioned dates as required. 2. Review of the facility medication refrigerator management log revealed: No logs dated for April, May, June 2024 were present in the binder. One log was labeled “September” without a year listed. The log dated February 2024 did not have an AM or PM temperature noted on 02/06/2024. The log dated July 2024 did not have an AM or PM temperature recorded on 07/13/2024, or a PM temperature recorded for 07/27/2024. The log dated “September” did not have a PM temperature recorded on 09/16. Employee #31 confirmed on 11/05/2024 that the medication refrigerator logs were incomplete and missing required information.”