Davita Fort Wayne North Dialysis

“Arrangement with Other Facilities CFR(s): §403.748(b)(7), §418.113(b)(5), §441.184(b)(7), §460.84(b)(8), §482.15(b)(7), §483.73(b)(7), §483.475(b)(7), §485.625(b)(7), §485.920(b)(6), §494.62(b)(6). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] *[For Hospices at §418.113(b), PRFTs at §441.184,(b) Hospitals at §482.15(b), and LTC Facilities at §483.73(b):] Policies and procedures. (7) [or (5)] The development of arrangements with other [facilities] [and] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. *[For PACE at §460.84(b), ICF/IIDs at §483.475(b), CAHs at §486.625(b), CMHCs at §485.920(b) and ESRD Facilities at §494.62(b):] Policies and procedures. (7) [or (6), (8)] The development of arrangements with other [facilities] [or] other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. *[For RNHCIs at §403.748(b):] Policies and procedures. (7) The development of arrangements with other RNHCIs and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of non-medical services to RNHCI patients. This Standard is not met as evidenced by: 44599 Based on record review and interview, the facility failed to obtain agreements with all hospital providers included in the EP plan to receive facility patients in the event the facility would be unable to provide services during an emergency for 1 of 1 facility. Findings include: 1. Review of the facility Emergency Management Plan indicated each facility shall have a prearranged hospital patient transfer agreement with local hospital(s) that can provide inpatient care, and routine and emergency dialysis. 2. Review of the facility EP plan included contact information for Entity 2 as a hospital provider to receive facility patients during an emergency. Documentation failed to evidence documentation of an agreement between the facility and Entity 2. During an interview on 11/25/2024 at 1:00 PM, when asked to see the hospital agreement with Entity 2, Group FA indicated could not find the agreement.”

“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: 44599 Based on record review and interview, the facility failed to ensure the EP communication plan included contact information for federal and state EP officials for 1 of 1 agency. Findings include: 1. Review of the facility’s EP communication plan failed to evidence contact information for the federal and state EP officials. During an interview on 11/25/2024 at 1:00 PM, when asked to see the contact information for the federal and state EP officials in the EP communication plan, the FA from another location indicated it is not in the EP communication plan.”

“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: 44599 Based on record review and interview, the facility failed to test the EP plan with participation in a full-scale community-based EP exercise, facility-based functional exercise, actual emergency of activation of the EP plan, mock disaster drill, or tabletop exercise for 1 of 1 agency. Findings include: 1. Review of the facility’s EP testing indicated participation in functional exercises, on 05/25/2022 and 06/28/2024, presented by the state Healthcare Coalition. The testing failed to identify facility employees who participated. The EP failed to evidence facility participation in a full-scale community-based exercise, actual emergency activation, mock disaster drill, or tabletop exercise for the past three years. 2. Review of the facility Safety Binder failed to evidence facility participation in mock disaster drills. 3. During an interview on 11/25/2025 at 1:00 PM, when asked who attended the functional exercise on 06/28/2024, the Group FA indicated FA’s from other locations attended the functional exercise. The FA indicated no one from this location attended.;”

“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: 44599 Based on observation, record review, and interview, the facility failed to ensure employees performed proper hand hygiene in 4 of 12 observations over 2 of 3 observation periods (PCT 2). Findings include: 1. Review of an agency policy titled “Infection Control for Dialysis Facilities” indicated all teammates will perform hand hygiene prior to gloving and immediately after removal of gloves and before touching clean areas such as supplies and chairside keyboard. 2. During an observation on 11/21/2024 at 11:49 AM, observed PCT 2 while wearing gloves touched skin below the eyes, and while wearing the same gloves disconnected the AV (arteriovenous) fistula (an artery and vein are surgically connected for dialysis) bloodline of Patient #6 at Station #9. 3. During an observation on 11/21/2024 at 12:55 PM, observed PCT 2 rubbing nose without wearing gloves and touched the chairside keyboard at Station #10. Observed PCT 2 don gloves without performing hand hygiene and cleaned and connected central venous catheter (tube inserted into a vein to provide access to the superior vena cava used for dialysis) bloodline of Patient #7, then removed gloves. PCT 2 failed to perform hand hygeine after removing gloves. 4. During an observation on 11/22/2024 at 9:56AM, observed PCT 2 don gloves without performing hand hygiene and picked up clean patient supplies from the treatment center counter and placed supplies on chairside table at Station #5 for the next patient. 5. During an observation on 11/22/2024 at 9:58 AM, observed PCT 2 while wearing gloves touch hair and while wearing the same gloves placed new dialysis tubing at Station #9 for use with the next patient. 6. During an interview on 11/22/2024 at 10:10 AM, when asked what should be done after touching face or hair while wearing gloves and providing care, PCT 2 indicated should remove gloves, use hand sanitizer and put on new gloves. When asked what is done before putting on new gloves, PCT 2 indicated should have used hand sanitizer before putting on gloves and after removing gloves.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44599 Based on observation and interview, the facility failed to ensure staff stored disinfectants in the treatment area to prevent loss of disinfectant properties to clean and disinfect the dialysis stations and equipment in 1 of 3 treatment floor observation periods completed creating the potential to affect all the facility’s 49 current incenter patients. Findings include: 1. During on observation 11/21/2024 at 10:51 AM, across from Station 3, observed two bleach containers, which are used for wetting paper towels for station cleaning, with opened lids. No employees observed cleaning at that time. During an interview on 11/21/2024 at 10:51 AM, when asked when the lids to the bleach containers can be open, PCT 1 indicated when using the bleach to clean. 3. During an observation on 11/21/2024 at 11:50 AM, across from Station 9, observed one bleach container with an opened lid. Further observations at 12:08 PM and 12:18 PM evidenced the same container lid remained open. No employees observed cleaning at those times. 4. During an interview on 11/22/2024 at 4:00 PM, when asked where the lids to the bleach containers should be, the FA indicated they should be left on top of the container.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 44599 Based on record review, observation, and interview, the medical director failed to ensure the policies and procedures related to patient care and safety were followed creating the potential to affect all 49 in-center dialysis patients. Findings include: 1. Review of an agency document titled “Parenteral (intravenous) Medication Preparation and Administration” indicated multiple dose vials are labeled with the date opened. 2. During an observation on 11/21/2024 at 10:10 AM, observed PCT 1 withdraw Heparin (blood thinner) into a syringe from an opened multiple dose vial at the medication prep area. Observation of the vial failed to evidence the date opened. During an interview on 11/21/2024 at 10:15 AM, when asked what is done to a multiple dose vial when opened, the FA indicated the vial should have been dated when opened.”

“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: 44599 Based on observation, record review, and interview, the facility failed to safeguard patient records against loss or unauthorized use for active and discharged patient records creating the potential to affect the facility’s patients on service within the past two years. Findings include: 1. Review of an agency policy titled “Medical Records Custodian and Maintenance” indicated hardcopy medical records for the previous 12 months are maintained in a secure medical records storage site in the facility, and medical records two years, but not less than 12 months should remain on site if space allows, and after that time, medical records may be stored off site with an approved medical records storage facility. 2. During the entrance conference on 11/21/2024, the Group FA indicated 90% of facility medical records are electronic and the remainder 10% are paper patient records and paper medical records older than 2 years are taken to Entity 1 for storage. 3. On 11/21/2024 and 11/22/2024 this writer was taken to an unlocked room in the administrative area of the facility and observed multiple banker boxes containing paper medical records. 4. On 11/25/2024 at 8:30 AM arrived at the facility and taken to the same unlocked room and observed the banker boxes with paper medical records were no longer present. 5. During an interview on 11/25/2024 at 9:32 AM, when asked what happened to the paper medical records that had been in the unlocked room, the FA from another location indicated the medical records that had been in the unlocked room were waiting to go to Entity 1 for storage. When asked to describe the measures the facility had taken to maintain the confidentiality of these records, the FA from another location indicated no one can walk in off the street because the facility interior doors are password protected. 6. A tour of the facility medical record storage site began on 11/25/2024 at 9:32 AM. Tour began in the patient lobby. Observed sliding glass windows with no visible locks which separated the lobby from the receptionist area. The FA from another location was unable to locate the brackets that lock the glass windows. No employees observed in the unsecured receptionist area. Walked from the lobby through a password protected door into the administration area and observed a locked door leading from the administration area to the receptionist area. Observed no door from the receptionist area to the medical record room and observed medical records in separate patient binders on shelves and in unlocked file cabinets. Observed the banker boxes with paper medical records stored in the medical record area. The facility failed to evidence paper medical records were stored in a secured space with the observation of no locks on the sliding glass windows that separated the front lobby to the medical record room.”