Davita South Yuma Dialysis

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 37489 Based on review of the facility Emergency Plan (EP) record review, and staff interview, it was determined the facility failed to develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must include contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers be reviewed and updated at least annually. Failure to have an emergency preparedness communication plan that includes specific information could lead to harm to both patients and staff. Findings include: The facility’s Emergency Plan related to a communication plan that included contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers that was reviewed and at least updated annually was requested on 12/20/2023. The Emergency Plan did not include an emergency preparedness communication plan that included current contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers and was not reviewed and at least updated annually. The administrator confirmed on 12/20/2023 that the EP plan did not identify an emergency preparedness communication plan that included current contact information related to staff, entities providing services under arrangement, next of kin, guardian or custodian, other facilities and volunteers, and was not reviewed annually.”

“Emergency Officials Contact Information CFR(s): §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This Standard is not met as evidenced by: 37489 Based on review of the facility Emergency Plan (EP) record review, and staff interview, it was determined the facility failed to develop an current emergency officials contact list. Failure to have an emergency officials contact list during an emergency could lead to harm to both patients and staff if specific Federal, State, tribal, regional, and local emergency preparedness staff or other sources of assistance are not known if the need to contact them should arise Findings include: Document review on 12/20/2023 revealed the facility failed to maintain a current complete list of Federal, State, tribal, regional, local emergency preparedness staff and Other sources of assistance. The administrator confirmed on 12/20/2023 that the facility failed to maintain a current complete list of Federal, State, tribal, regional, local emergency preparedness staff and Other sources of assistance.”

“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: During document review on 12/20/2023 it was revealed the facility was missing documents proving participation in a full-scale exercise (FSE) that was community-based or facility based exercise or table top drills for the last two cycles (four years). A facility based drill was conducted 06/22/2022 and 06/22/2023, and a community exercise was conducted on 10/20/2022. No additional documents were provided. Employee #1 confirmed on 12/20/2023 that the facility was not able to locate proof of participation in exercises that were community-based or facility based exercises for the last four years.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure compliance with applicable State laws for handling and storage of biohazardous medical waste which has the potential for transmission of infectious agents. Findings include: The “Arizona Administrative Code (A.A.C.)” requires: “...Title 18. ENVIRONMENTAL QUALITY...CHAPTER 13. DEPARTMENT OF ENVIRONMENTAL QUALITY - SOLID WASTE MANAGEMENT...ARTICLE 14 BIOHAZARDOUS MEDICAL WASTE AND DISCARDED DRUGS...R18-13-1408 Storage...C. Beginning at the time the waste is set out for collection, a generator who stores biohazardous medical waste shall comply with all of the following requirements: ...5. Keep the storage area free of visible contamination...6. Protect biohazardous medical waste from contact with water, precipitation, wind, or animals. A generator shall ensure that the waste does not provide a breeding place or a food source for insects or rodents....” The facility policy titled “ON-SITE STORAGE OF MEDICAL WASTE” did not address storage conditions for facility outdoor storage areas as outlined in the requirements listed in Arizona Administrative Code. The only requirement listed in the facility policy for outdoor storage areas listed that the waste be locked and conspicuously marked with the international biohazard symbol. Observation on 12/19/2023 revealed Employee #14 carrying a red biohazard trash bag out a back door of the facility. Employee #14 disposed of the trash bag in a rigid container in a block wall area outdoors behind the facility. The block wall enclosure spanned four sides to create a rectangular enclosure approximately eight feet tall with an approximately three-foot-wide welded square metal tube gate on the front side of the enclosure for entry to the enclosure. The gate was constructed of square tubing slats approximately three to four inches apart similar in appearance to a pool fencing gate which would allow for pass through and was not a solid door structure. The top of the rectangular enclosure was covered with chain link fencing with a black shade cloth attached over the top of the chain link. The inside of the enclosure contained multiple rigid red biohazard plastic totes along with cardboard containers used to contain/store the rigid plastic containers containing biohazard sharps containers. The ground inside the enclosure was littered with debris, exam gloves, and trash. The area used for storage of biohazardous medical waste and sharps was not protected from wind, precipitation, wind, or animals which could easily enter through the top of the enclosure and the open slat designed gate. Employee #14 confirmed on 12/20/2023 that biohazardous medical waste and sharps are stored outside in an enclosure that is not protected from wind, rain, animals, or insects, and that the area tends to collect trash and debris due to the open top and open gate design of the storage area. Additionally, Employee #14 confirmed that the cardboard storage boxes get damaged and/or disintegrate during rainy conditions which affects pick up of the waste by the transporter during these events.”

“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: 45999 Based on observation, review of policies and procedures, and staff interview, it was determined that the facility failed to ensure: 1. that visitors wear personal protective gowns and also wear a face shield appropriately when holding a patient’s vascular access site which poses a potential risk of cross contamination and infection between patients and patients and visitors; and 2. that staff thoroughly cleaned and disinfected the dialysis machine and station between patients which poses a potential risk of infection and cross contamination between patients. Cross reference tag V116. Findings include: A review of policy titled “FACILITY VISITATION” revealed: “...A visitor is considered to be any non-teammate who may be, but not limited to ... not receiving treatment but is in the treatment area with an individual who is receiving treatment ...DaVita adheres to strict procedures for allowing visitors in the dialysis facility without compromising patient care....” Observation during facility tours on December 19, 2023, revealed that a visitor was sitting with patient #10, the visitor was sitting with a gown completely unbuttoned. When patient #10’s treatment was completed the same visitor was holding the patient’s access with the gown only buttoned with three buttons in the middle, gloves, and mask but no shield. Employees #1 and #2 confirmed during an interview conducted on December 20, 2023, that visitors are required to wear gowns completely secured with no personal clothing exposed and also wear a face shield when helping the patient to hold their vascular access site. 2. The facility policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” requires: “...At the end of each treatment, the dialysis station/training will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops)...Non-disposable items are to be disinfected after each patient use...If item cannot be cleaned and disinfected it will be dedicated for use on a single patient....” Observation on 12/19/2023 revealed Employee #5 cleaning and disinfecting station #2. The employee did not wipe all surfaces of the dialysis machine with disinfectant including the face of the machine, IV pole, bicarbonate dissolutionment cartridge and missed areas on the dialysis chair. Observation on 12/19/2023 revealed Employee #13 cleaning and disinfecting stations #8 and 9. The employee did not wipe all surfaces of the dialysis machines with disinfectant including face of the machines, bicarbonate dissolutionment cartridges, and IV poles. Observation on 12/19/2023 revealed Employee #8 cleaning and disinfecting station #18. The employee did not wipe the heparin holder, bicarbonate dissolution cartridge, lower front of machine, back of machine, side of machine next to the dialysis chair, left side arm that meets the back of the chair, left corner of foot rest, and outside of left arm rest with disinfectant. Observation on 12/19/2023 revealed Employee #13 cleaning and disinfecting statin #6. The employee did not wipe the edges of the dialysis machine, dialysis chair, bicarbonate dissolutionment cartridge, and back of the chair with disinfectant. Employees #1 and 2 confirmed on 12/20/2023 that staff did not clean and disinfect the dialysis stations as required by facility policy.”

“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: 45999 Based on a review of policy and procedure, observation, and staff interview, it was determined that the facility failed to ensure staff appropriately cleansed (2) of (2) patients (Patients #11, #12) vascular access prior to cannulation with fistula needles. Failure to practice safe aseptic technique when cleansing and disinfecting a patient’s vascular access increases the risk for vascular access and bloodstream infection if bacteria are not sufficiently reduced at the cannulation sites prior to needle insertion. Findings include: The policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” requires: “...Check for patient sensitivity to preferred skin antiseptic/skin disinfectant listed in table below (povidone iodine, hypochlorite ExSept Plus Isopropyl Alcohol 70%). If using Hypochlorite (ExSept Plus) ...if using sterile 2x2 gauze saturate with 3-5ml...Effective Contact Time...60 seconds with effective dry time ...2 minutes....” Observation on December 19, 2023, revealed Employee #5 preparing to cannulate Patient #11’s vascular access with fistula needles. Employee #5 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the arterial site for 38 seconds. Employee #5 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the venous site for 103 seconds, then allowed the site to dry for two minutes and twenty seconds, and then cannulated with the fistula needles. Observation also revealed on December 19, 2023, Employee #8 preparing to cannulate Patient #12’s vascular access with fistula needles. Employee #8 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the arterial site for 6 seconds then allowed the site to dry for 20 seconds and proceeded to cannulate the site with a fistula needle. Employee #8 used a 2x2 saturated with hypochlorite ExSept Plus to disinfect the venous site for 6 seconds, then allowed the site to dry for 20 seconds, and then cannulated with a fistula needle. Employees # 1 and # 2 confirmed on December 20, 2023, that Employees #5, and #8, did not apply the Hypochlorite ExSept Plus for the required 60 seconds prior to cannulation of Patient #11, # 12’s vascular access with fistula needles as required by facility policy.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure that staff discarded bicarbonate cartridges after dialysis treatment which poses a potential risk of cross contamination and infection if disposable supplies are used on multiple patients. Cross reference tag V111 Findings include: The facility policy titled “BICARBONATE CARTRIDGES” requires: “...To maintain bicarbonate online dissolutionment cartridges free of contamination...Bicarbonate online dissolutionment cartridges are considered single use products and may not be removed from the dialysis machine for use at a future point in time...Single use is considered one continuous use event on a single machine...Bicarbonate dissolutionment cartridges will be labeled with date, time and initials when they are first primed...The unused portion of the bicarbonate online dissolutionment cartridge is discarded at the end of the treatment and before the machine undergoes cleaning....” Observation on 12/19/2023 revealed staff dismissing patients from treatment and setting up dialysis stations/machines for another patient without discarding the unused portion of the bicarbonate online dissolutionment cartridges for stations #2, 6, 8, 9, and 18. The bicarbonate cartridges were used on multiple patients until empty. Employee #2 confirmed on 12/20/2023 that the cartridges are not discarded after single patient use as required by facility policy for any of the dialysis stations in the facility.”

“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: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure: 1. staff secured patient medications when not in use or under supervision which poses a potential risk for medications to be contaminated and/or tampered with by unauthorized persons; 2. staff labeled and dated glucose test strips and control test solutions when opened which poses a potential risk that expired supplies are used which may be ineffective for providing patient care. Findings include: 1. The facility policy titled “Medication Policy” requires: “...All refrigerated medications...and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinets(s) and locked at the close of each business day or if not under the supervision by the licensed teammate or per state regulations....” Observation on 12/20/2023 revealed an unlocked medication refrigerator containing multiple injectable vaccines in the medication preparation area. No staff were present in the area providing supervision of the vaccines during the observation. Employee #11 confirmed on 12/20/2023 that the vaccine refrigerator was not locked as required when medications were unsupervised. Observation on 12/20/2023 revealed Employee #8 prepare multiple pre-drawn heparin syringes. Employee #8 then placed the medication syringes on a workspace in a clear baggie and several in chux with other dialysis supplies and leave the area. No staff were present in the area during the observation. Employee #11 confirmed on 12/20/2023 that Employee #8 did not lock and secure the heparin syringes in the drawer at his/her workstation as required by facility policy. 2. Observation on 12/20/2023 revealed two (2) open glucose test strip vials and two (2) open glucose test control solutions that were undated and unlabeled. The glucose test strips revealed that the manufacturer requires that they be discarded within (4) months after first open. The control test solution package insert required that the solutions be discarded within (3) months after opening the vials. Employee #11 confirmed on 12/20/2023 that the glucose test strips and control solutions were not labeled with an open date as required to ensure staff knew when the expiration date was to discard the supplies.”

“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: 49430 Based on document review, observation, and interview, it was determined that the facility failed to ensure compliance with the Life Safety Code (LSC) of the National Fire Protection Association (NFPA) by not keeping a current, yearly city fire inspection which has the potential risk of harm to patients if identifiable fire sources are not removed/repaired, increasing the risk of a fire in the facility. Findings include: Policy titled “Facility Emergency Management Plan” requires “a. Maintenance, inspection, and testing must be conducted by a certified vendor, as required by state or local regulations...Service records will be made available upon request...” Yearly city fire inspections are required for outpatient treatment centers per the Fire Code of the City of Yuma. Employee #2 confirmed on 12/20/2023 absence of a current city fire inspection.”

“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: 49430 Based on review of facility policy, medical records and interview, it was determined that the facility failed to ensure that staff followed the attending physicians prescribed hemodialysis (HD) order for blood flow rate for patients #2 and 4. Failure to follow physician orders poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations. Findings Include: Patient #2 Treatment Sheet 12/4/23: Blood Flow Rate (BFR) ordered 550 ml/min. BFR charted 400 ml/min at 11:01-13:57 without any charted reason for deviation from physician order. Patient #4 Treatment Sheet 12/13/23: BF ordered 400 ml/min. BF charted 450 ml/min during entire treatments without any charted reason for deviation from physician order. Treatment Sheet 12/6/23: BF ordered 400 ml/min. BF charted 450 ml/min during entire treatments without any charted reason for deviation from physician order. Employees #1 and 2 confirmed on 12/20/2023 that staff failed to ensure the ordered BFR was followed for the aforementioned patients.”

“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: 49430 Based on review of facility policy, medical records and interview, it was determined that the facility failed to ensure that staff followed the attending physicians prescribed hemodialysis (HD) order for blood flow rate for patients #2 and 4. Failure to follow physician orders poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations. Findings Include: Patient #2 Treatment Sheet 12/4/23: Blood Flow Rate (BFR) ordered 550 ml/min. BFR charted 400 ml/min at 11:01-13:57 without any charted reason for deviation from physician order. Patient #4 Treatment Sheet 12/13/23: BF ordered 400 ml/min. BF charted 450 ml/min during entire treatments without any charted reason for deviation from physician order. Treatment Sheet 12/6/23: BF ordered 400 ml/min. BF charted 450 ml/min during entire treatments without any charted reason for deviation from physician order. Employees #1 and 2 confirmed on 12/20/2023 that staff failed to ensure the ordered BFR was followed for the aforementioned patients. Based on review of facility policy and procedure, medical records, and interview it was determined that the facility failed to ensure RNs and PCTs monitored, assessed, and documented abnormal findings for (6) of (6) patients during treatment (Patients #1, 2, 3, 4, 5 and 6 ). This deficient practice limits the interdisciplinary team (IDT) in addressing blood pressure, heart rate, and fluid management issues in the patient’s plan of care if treatment data is not documented, assessed, and addressed in the patient’s medical record. Findings include: The facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” requires: “...Patient data will be obtained and documented...Data collection includes...Measurement of Blood Pressure...Intradialytic Data Collection/Assessment...Vital signs and treatment monitoring...At a minimum, obtain and document...Blood pressure...Abnormal findings...will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician...as needed of changes in patient status...Abnormal Findings...Blood pressure: Pre-dialysis ...Systolic greater than 180 mm Hg ...Diastolic greater than or equal to 100 mm Hg ...Blood Pressure-Intradialytic...Difference of 20 mm/Hg increase or decrease from patient’s last intradialytic treatment BP reading ...Post Treatment ...Standing systolic BP greater than 140 mm Hg ...Standing diastolic BP greater than 90 mm Hg ...Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute....” Review of Patient Treatment Sheets reveals: Patient #1 Treatment Sheet 12/16/23: 07:32 - Heart Rate (HR) 53. No note charted Registered Nurse (RN) notified or RN assessment noted. 08:02 - HR 123. No note charted Registered Nurse (RN) notified or RN assessment noted. 06:33-07:01 Blood Pressure (BP) decreased more than 20 mm HG without RN notification charted. 07:01-07:32 BP increased more than 20 mm HG without RN notification charted. Treatment Sheet 12/14/23: 07:01-07:31 BP increased more than 20 mm HG without RN notification charted. Treatment Sheet 12/12/23: 06:01 - HR 59 without RN noted or assessment. 08:02 - HR 38 No note charted Registered Nurse (RN) notified or RN assessment noted. 08:32 - HR 31 without RN noted or assessment. 05:31-06:01 BP decreased more than 20 mm HG without RN notification charted. 06:01-06:32 BP increased more than 20 mm HG without RN notification charted. 06:01-06:32 Vital Signs greater than 30 min interval. Treatment Sheet 12/9/23: 07:31-08:02 BP increased more than 20 mm HG without RN notification charted. 08:02-08:33 BP decreased more than 20 mm HG without RN notification charted. 08:02 BP 193/90 No note charted Registered Nurse (RN) notified or RN assessment noted. 06:01-06:35 Vital Signs greater than 30 min interval. 07:31-08:02 Vital Signs greater than 30 min interval. 08:02-08:33 Vital Signs greater than 30 min interval. Patient #2 Treatment Sheet 12/8/23: 11:32-12:01 BP increased more than 20 mm HG without RN notification charted. Treatment Sheet 12/6/23: 12:02-12:32 BP increased more than 20 mm HG without RN notification charted. 13:01-13:34 Vital Signs greater than 30 min interval. Treatment Sheet 12/4/23: 12:01-12:31 BP decreased more than 20 mm HG without RN notification charted. Patient #3 Treatment Sheet 12/18/23: 05:50 BP 235/124. No note charted Registered Nurse (RN) notified or RN assessment noted. 06:02 BP 183/80. No note charted Registered Nurse (RN) notified or RN assessment noted. 06:02-06:32 BP decreased more than 20 mm HG without RN notification charted. 07:31 - HR 59. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/11/23: 07:07-07:32 Vital Signs greater than 30 min interval. Treatment Sheet 12/13/23: 08:02-08:31 BP increased more than 20 mm HG without RN notification charted. 05:57-09:02 BP decreased more than 20 mm HG without RN notification charted. 07:01-07:33 Vital Signs greater than 30 min interval. Treatment Sheet 12/8/23: 06:31-07:02 BP increased more than 20 mm HG without RN notification charted. 07:02-07:34 BP decreased more than 20 mm HG without RN notification charted. 06:31-07:02 Vital Signs greater than 30 min interval. 07:02-07:34 Vital Signs greater than 30 min interval. Patient #4 Treatment Sheet 12/11/23: 13:31 - HR 100. No note charted Registered Nurse (RN) notified or RN assessment noted. 13:41 - HR 100. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/8/23: 12:31-13:01 BP decreased more than 20 mm HG without RN notification charted. 13:01-13:31 BP increased more than 20 mm HG without RN notification charted. Patient #5 Treatment Sheet 12/16/23: 11:31-12:01 BP increased more than 20 mm HG without RN notification charted. 10:31-11:02 Vital Signs greater than 30 min interval. Treatment Sheet 12/14/23: 12:01-12:31 BP increased more than 20 mm HG without RN notification charted. 10:01-10:32 Vital Signs greater than 30 min interval. Treatment Sheet 12/12/23: 09:33 - HR 56. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:02 - HR 56. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:32 - HR 55. No note charted Registered Nurse (RN) notified or RN assessment noted. 11:02 - HR 55. No note charted Registered Nurse (RN) notified or RN assessment noted. 12:02 - HR 59. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/9/23: 09:47 - HR 59. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:01 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/7/23: 10:02 - HR 59. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:16 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:18 - HR 56. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:22 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:31 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:46 - HR 59. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:47 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. 11:01- HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. 11:16 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/5/23: 09:49 - HR 56. No note charted Registered Nurse (RN) notified or RN assessment noted. 10:01 - HR 57. No note charted Registered Nurse (RN) notified or RN assessment noted. 11:01-11:32 Vital Signs greater than 30 min interval. Patient #6 Treatment Sheet 12/9/23 13:30-14:01 Vital Signs greater than 30 min interval. Treatment Sheet 12/7/23 14:01 BP 206/102. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:31 BP 212/119. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:01 - HR 102. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:31 - HR 100. No note charted Registered Nurse (RN) notified or RN assessment noted. 16:01 - HR 103. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/5/23: 13:28 BP 213/136. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:01 BP 213/124. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:32 BP 245/127. No note charted Registered Nurse (RN) notified or RN assessment noted. 16:01 BP 187/114. No note charted Registered Nurse (RN) notified or RN assessment noted. 16:12 BP 187/98. No note charted Registered Nurse (RN) notified or RN assessment noted. Treatment Sheet 12/2/23: 15:31-16:01 BP decreased more than 20 mm HG without RN notification charted. Treatment Sheet 11/28/23: 13:32 - HR 117. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:01 - HR 114. No note charted Registered Nurse (RN) notified or RN assessment noted. 14:01-1500 Vital Signs greater than 30 min interval. Employee #1 and 2 confirmed on 12/19/2023 that staff failed to ensure RNs and PCTs monitored, assessed, and documented abnormal findings for the aforementioned patients and medical records.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 49430 Based on review of facility policy, medical records and interview, it was determined that the facility failed to ensure AMAs (against medical advice) forms were completed for treatment times not met for (4) of (6) patients (Patients #1, 3, 4 and 6) with early termination of treatment which has the potential risk of adverse events related to inadequate dialysis. Findings include: The facility policy titled “Prescribed Treatment Time Not Met” requires: “...1. The Registered Nurse (RN) will verify that a patient signs the Early termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time....4. A copy of the Early termination of Treatment Against Medical Advice form signed by the patient, if shortened voluntarily by the patient, will be kept in the patient’s health record....” Document titled “Davita Governing Body Meeting” states “...per Dr Lim MD orders, patients who decide to terminate treatment with </= 10 mins remaining, will not be required to sign an AMA. Pt’s will be given education and follow up instructions....”. The following sited AMA’s were in excess of 10 minutes; Patient #1 Treatment records dated 11/20/2023 through 12/19/2023 revealed (4) of (13) treatments were terminated early. The medical record did not contain AMA documentation for (1) of the (4) early terminated treatments. Patient #3 Treatment records dated 11/19/2023 through 12/18/2023 revealed (4) of (13) treatments were terminated early. The medical record did not contain AMA documentation for (1) of the (4) early terminated treatments. Patient #4 Treatment records dated 11/19/2023 through 12/18/2023 revealed (6) of (13) treatments were terminated early. The medical record did not contain AMA documentation for (2) of the (6) early terminated treatments. Patient #6 Treatment records dated 11/18/2023 through 12/16/2023 revealed (11) of (13) treatments were terminated early. The medical record did not contain AMA documentation for (2) of the (11) early terminated treatments. Employees #1 and 2 confirmed on 12/20/2023 that medical records were not completed for treatment times not met for the aforementioned patients as required.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. 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 stored patient medical records in a secure manner. Failure to store patient medical records per facility policy poses the potential risk of unauthorized use. Findings include: The facility policy titled “Medical Records Custodian and Maintenance” requires: “...A purged medical record will be created for each patient and maintained in the same order as the active record. The information that is removed from the permanent medical record is placed in the patient’s purged record. The purged records are kept in a secure medical records storage site in the facility....” Observation on 12/19/2023 revealed multiple thinned and discharged patients’ medical records in bankers style boxes on a shelving unit in an unlocked storage room with a paper label on the door that read “OXYGEN.” Employee #1 and 2 confirmed on 12/19/2023 that the medical records for discharged patients and thinned charts were not secured.”