Fmc - Kokomo

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility 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. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to implement its EP policies and procedures by failing to ensure all emergency drugs were on-site at all times, which had the potential to affect all 108 active patients. Findings include: 1. The facility policy #46865 “Emergency Medications, Equipment and Supplies,” dated 2/03/25, indicated the facility must maintain at least two doses of Calcium Chloride on-site “to manage emergency situations.” 2. An observation of the facility’s emergency medications available on-site on 5/12/25 beginning at 9:17 AM failed to evidence the emergency drug Calcium Chloride. 3. During an interview on 5/12/25 beginning at 9:30 AM, Charge Nurse 1 reported the agency did not have Calcium Chloride on the premises. 4. During an interview on 5/19/25 beginning at 4:16 PM, Administrator was unsure of the reason Calcium Chloride was not kept on-site.”

“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: 42617 Based on EP plan review, policy review, and interview, the dialysis facility failed to maintain and update its communication plan to include federal and state emergency preparedness staff and other sources of assistance, which had the potential to affect 108 active patients and all staff. Findings include: 1. The facility policy #25907 “Guidelines for Emergency Preparedness,” dated 7/03/23, indicated the facility “must develop a communication plan” which was to include “facility emergency information contact lists ....” 2. The review of the facility’s EP communication plan failed to evidence contact information for federal and state EP staff as well as other sources of assistance. 3. During an interview on 5/19/25 beginning at 4:16 PM, Administrator was unsure of the reason a list of EP official contacts and other sources of assistance was not included 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: 42617 Based on EP review, policy review, and interview, the dialysis facility failed to revise and enact changes to the EP plan based on after-action reviews (AAR) of its EP testing, which had the potential to affect 108 active patients and staff. Findings include: 1. The facility policy “Guidelines for Emergency Preparedness,” dated 7/03/23, indicated if a facility activated its emergency plan for a disaster, an after-action review was to be completed, and the plan was to be revised as needed. 2. The facility’s EP documentation evidenced the home therapy division conducted a fire tabletop drill on 3/13/24. An AAR of the drill evidenced opportunities for improvement included “pull fire alarm to notify other tenants of [the building],” which would include the ICHD treatment floor, and “take emergency cart with evacuation.” The facility’s improvement plan included repeating the drill within six months. The EP documentation failed to evidence a repeat fire drill which included the home therapy division had been completed. During an interview on 5/19/25 beginning at 3:20 PM, Home Therapy Manager 4 reported he was not aware if a follow-up fire drill had been conducted. During an interview on 5/19/25 beginning at 4:16 PM, Administrator was not aware if a follow-up fire drill including the home therapy division had been conducted. 3. The agency’s EP documentation evidenced the facility activated its EP plan for a “blizzard” on 1/06/25. The AAR of the EPP activation identified “improvement plans or action steps needed to help [the facility] be more prepared in case of a disaster” was “Patient communication.” The EP documentation failed to evidence further details regarding revisions to the EPP or action steps to be taken to improve the EPP based on the AAR. During an interview on 5/19/25 beginning at 4:16 PM, Administrator after the activation of the facility’s EP plan on 1/06/25, the facility found many patients did not come for their scheduled ICHD treatment despite the facility remaining open, and the facility needed to improve its communication with patients by reach out via phone if there was advanced warning of severe weather. The EP documentation failed to evidence the recommended changes were revised in the EP plan and enacted.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to maintain a sanitary environment within the ICHD treatment area for 2 of 2 days of ICHD treatment area observations, which had the potential to affect 76 active ICHD patients. Findings include: 1. The policy “Cleaning and Disinfecting the Dialysis Station,” dated 9/05/23, indicated bleach solution would be stored in “covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air.” 2. The policy “General Cleanliness and Infection Control Guidelines,” dated 11/04/24, indicated “supplies ... should not be kept or stored behind the machine at the patient station.” 3. During an ICHD flash tour on 5/12/25 beginning at 8:38 AM - 9:35 AM, three containers with 1:100 concentration bleach solution were observed without a lid completely covering the solution on one occasion. One face shield was observed sitting on the chaise wall immediately behind Station 2 while a patient was dialyzing at the station. 4. During an ICHD observation on 5/12/25 from 10:45 AM - 12:28 PM, two containers of 1:100 concentration bleach solution were observed without a lid completely covering the solution on four occasions. 5. During an ICHD observation on 5/13/25 from 9:23 AM - 10:57 AM, two containers of 1:100 concentration bleach solution and one container of 1:10 concentration bleach solution were observed without a lid completely covering the solution on two occasions. At 9:43 AM, PCT 2 dipped gauze wipes into a container of 1:100 concentration bleach solution. After wetting the gauze, the technician failed to return the lid to where it completely covered the solution. At 9:23 AM, four face shields and staff binders used to prepare tape for fistula cannulation were observed stored on a counter behind Stations 19 and 20. Patient #25 was dialyzing in Station 19, directly in front of the stored supplies. At 10:50 AM, the face shields and staff binders remained on the counter behind Stations 19 and 20. Patient #30 was sitting in Station 20 preparing to begin dialysis treatment. 6. During an interview on 5/12/25 beginning at 2:19 PM, PCT 4 reported bleach solution should be stored in containers with the lids on, as light would “dilute” the bleach concentration. 7. During an interview on 5/12/25 beginning at 3:12 PM, PCT 6 reported bleach solution should be stored in containers with the lid on. 8. During an interview on 5/12/25 beginning at 3:21 PM, PCT 5 reported bleach solution should be stored in containers with the lid on. 9. During an interview on 5/13/25 beginning at 9:47 AM, PCT 3 reported bleach solution should be stored in containers with the lid on. 10. During an interview on 5/13/25 beginning at 3:19 PM, Charge Nurse 1 reported bleach solution should be stored in a container with the lid on. The nurse also reported face shields and staff binders should not be stored behind treatment stations.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff and patients followed facility infection control policies and procedures for 6 of 10 staff observed performing procedures on the ICHD treatment floor (PCT 1, PCT 2, PCT 4, PCT 7, RN 2, RN 3). Findings include: 1. The facility policy “Hand Hygiene”, dated 11/06/23, indicated hand hygiene should be performed “before and after direct contact with patients ... before performing any invasive procedure such as vascular access cannulation or administration of parenteral [administered through a non-oral route] medications. Immediately after removing gloves ... After contact with inanimate objects near the patient ... After contact with other objects within the patient station or treatment space.” The policy also indicated patients should perform hand hygiene after each dialysis treatment “to help ensure the prevention of cross contamination to [patients’] family members or other patients. Gloves were to be provided to patients “when performing procedures which risk exposure to blood or body fluids, such as ... holding [fistula or graft] access sites post treatment ....” 2. The facility policy “Access Assessment and Cannulation,” dated 5/05/25, indicated when cannulating a fistula, staff should evaluate the access area, remove gloves, perform hand hygiene, don new gloves, then apply antiseptic to each cannulation site. 3. The facility policy “Termination of Treatment Using a Central Venous Catheter ...,” dated 2/07/22, indicated after a patient’s treatment was complete, staff were to return blood from the dialysis machine and tubing, obtain the patient’s sitting and standing blood pressure, remove their gloves, perform hand hygiene, don new gloves, and disconnect the patient’s dialysis lines from the CVC. 4. During an ICHD treatment floor observation on 5/12/25 beginning at 10:50 AM, PCT 1 was in Station 1 preparing Patient #5 for their dialysis treatment. The technician left the station, picked up a thermometer sitting above a hand washing sink, re-entered the station, and obtained Patient’s temperature. PCT 1 then left the station, returned the thermometer, re-entered Station 1, donned new gloves, and continued preparing Patient #5 for dialysis. The technician failed to perform hand hygiene prior to donning gloves. During an interview on 5/13/25 beginning at 3:16 PM, PCT 1 reported hand hygiene should be performed prior to donning gloves. 5. During an ICHD treatment floor observation on 5/12/25 beginning at 11:19 AM, PCT 4 was in Station 12 cannulating Patient #16’s fistula. The technician evaluated the access then applied antiseptic over the cannulation sites, failing to change gloves and perform hand hygiene prior to applying the antiseptic. During an interview on 5/12/25 beginning at 2:19 PM, PCT 4 reported when cannulating a fistula, gloves should be changed and hand hygiene performed between evaluating the fistula and applying antiseptic. 6. During an ICHD treatment floor observation on 5/12/25 beginning at 12:20 PM, RN 2 was at the medication preparation counter preparing an IV medication for Patient #18. The nurse took the medication syringe to Station 9, donned gloves, then injected the medication into a port on the dialysis tubing. The nurse failed to perform hand hygiene prior to donning gloves. During an interview on 5/12/25 beginning at 2:42 PM, RN 2 reported staff should perform hand hygiene prior to donning gloves. 7. During an ICHD treatment floor observation on 5/12/25 beginning at 11:45 AM, PCT 4 removed Patient #17’s fistula needles in Station 11 at the end of treatment. Patient donned a glove and held pressure to both cannulation sites. After the sites had stopped bleeding, Patient removed their glove. RN 3 walked with Patient from the station to the treatment doorway. PCT 4 and RN 3 failed to instruct Patient to perform hand hygiene after removing their glove. During an interview on 5/12/25 beginning at 2:19 PM, PCT 4 reported patients were to perform hand hygiene after holding pressure to their cannulation sites and removing their glove. The technician was unsure if Patient was advised to perform hand hygiene after their treatment as RN 3 had walked Patient out of the treatment floor. During an interview on 5/12/25 beginning at 3:09 PM, RN 3 could not recall if Patient #17 was advised to perform hand hygiene after holding pressure to their cannulation sites and removing their glove. 8. During an ICHD treatment floor observation on 5/13/25 beginning at 10:19 AM, PCT 7 removed Patient #22’s fistula needles in Station 16 at the end of treatment. Patient donned a glove and held pressure to both fistula cannulation sites. After the site had stopped bleeding, Patient removed their glove, and PCT 7 walked Patient from the station to the treatment doorway. PCT 7 failed to instruct Patient to perform hand hygiene after removing their glove. During an interview on 5/13/25 beginning at 3:13 PM, PCT 7 reported the patient should perform hand hygiene after holding pressure to cannulation sites and removing their glove. The technician was unsure if Patient performed hand hygiene on 5/13/25 because Patient “leaves quickly” after treatment. 9. During an ICHD treatment floor observation on 5/13/25 beginning at 10:39 AM, PCT 2 was in Station 14 discontinuing Patient #21’s dialysis. Patient had a CVC. The technician reinfused the extracorporeal circuit, moved Patient’s belongings, assisted Patient in standing to obtain a BP, then disconnected the blood lines and disinfected the CVC’s open hubs. PCT 2 failed to change gloves and perform hand hygiene prior to disconnecting the blood lines and disinfecting the CVC open hubs. During an interview on 5/13/25 beginning at 3:09 PM, PCT reported when discontinuing dialysis from a CVC, staff should change gloves and perform hand hygiene before disconnecting the blood lines from the CVC. 10. During an interview on 5/13/25 beginning at 3:19 PM, Charge Nurse 1 reported staff should perform hand hygiene prior to donning gloves. Staff should remind patients to perform hand hygiene after the patient holds pressure to a fistula cannulation site. Charge Nurse 1 reported when discontinuing dialysis from a CVC, staff should change gloves and perform hand hygiene after disconnecting the blood lines and before cleaning the CVC hubs.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 42617 Based on personnel file review and interview, the dialysis facility failed to ensure all staff susceptible to Hepatitis B were offered the vaccine series upon hire for 1 of 3 ICHD personnel files reviewed (Employee C). Findings include: 1. The review of Employee C’s personnel file evidenced a hire date of 7/22/24. The employee’s duties included direct patient contact. The file indicated the employee completed an Anti-HBS blood test (evaluates for the presence of antibodies in the blood which indicate immunity or susceptibility to the hepatitis B virus) on 11/06/24. The employee’s result was “<10,” indicating the employee was susceptible to Hepatitis B. The file failed to evidence the employee received or declined the Hepatitis B vaccine series upon hire. During an interview on 5/19/25 beginning at 4:06 PM, Administrator reported the facility did not have record of Employee C being offered the Hepatitis B vaccine upon hire.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 42617 Based on personnel file review, policy review, and interview, the dialysis facility failed to implement infection control policies and procedures specific to ensuring all staff had been screened for tuberculosis prior to direct patient contact for 1 of 3 home dialysis personnel files reviewed (Employee A) and 3 of 3 ICHD personnel files reviewed (Employees B, C, D). Findings include: 1. A facility policy #47630 “Employee Tuberculosis [TB, a highly contagious respiratory infection] Testing,” dated 5/05/25, indicated a two-step tuberculin skin test (TST, a screening test for TB, which is done by injecting an inactive form of TB under the skin on 2 separate occasions and assessing the area for a reaction) would be performed on hire. If the first-step TB test had a negative result (no evidence of reaction), the second-step TB test was to be completed within 1-3 weeks. 2. The review of Employee A’s personnel file evidenced a hire date of 2/06/23. The employee’s duties included direct patient contact. The file indicated the employee received a first-step TST on 4/23/24. The file failed to evidence the employee had completed a second step TST. Employee A completed a “Tuberculosis Risk Assessment Employee Questionnaire” form on 3/12/25. The employee indicated he/she had experienced symptoms of TB including “Change in cough or coughing up blood ... Fever or night sweats for more than 1 week ... Recent ‘cold’ or upper respiratory infection lasting more than 7-10 days ....” The file failed to evidence further investigation was conducted based on the employee’s answers. During an interview on 5/19/25 beginning at 10:16 AM, Home Therapy Manager 4 reported a two-step TST was performed on hire, unless the employee had performed a TST in the “past few years.” If the employee had a previous TST, a copy was to be obtained and placed in the employee’s personnel file. The manager stated if an employee reported potential symptoms of TB on the questionnaire, the employee would be sent for a chest x-ray. Home Therapy Manager 4 was unsure if there had been any follow-up to Employee A’s potential symptoms of TB on 3/12/25. During an interview on 5/19/25 beginning at 11:28 AM, Employee A reported he/she had one TST performed upon hire. The employee reported the facility did not perform any follow-up to the TB questionnaire completed on 3/12/25. 3. The review of Employee B’s personnel file evidenced a hire date of 4/29/24. The employee’s duties included direct patient contact. The file failed to evidence the employee was screened for TB prior to date of survey entrance. 4. The review of Employee C’s personnel file evidenced a hire date of 7/22/24. The employee’s duties included direct patient contact. The file indicated the employee received a first-step TST on 11/06/24. The file failed to evidence the employee had completed a second-step TST. 5. The review of Employee D’s personnel file evidenced a hire date of 11/11/24. The employee’s duties included direct patient contact. The file indicated the employee received a first-step TST on 3/05/25. The file failed to evidence the employee had completed a second-step TST. 6. During an interview on 5/19/25 beginning at 4:06 PM, Administrator reported all employees were to complete one TST upon hire. Administrator reported the facility did not have record of Employee B completing a TST prior to survey entrance. Employee C and Employee D’s first-step TST was done late as the facility was “catching up” to performing TSTs on hire. Administrator reported he had not been performing a second step TST on hire.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure all patients access sites were visible for 2 of 2 days of ICHD treatment observations and failed to ensure all staff documented access site checks according to facility policy for 4 of 6 ICHD records reviewed (Patients #1, 2, 3, 4). Findings include: 1. The facility policy “Patient Assessment and Monitoring,” dated 5/01/23, indicated safety checks were to be documented “every 30 [minutes] ... not to exceed 45 minutes.” Staff were to ensure the patient’s access site “remains uncovered throughout the treatment.” 2. During an ICHD flash tour on 5/12/25 beginning at 8:38 AM, the following was observed: a. At 8:38 AM, Patient #11 was receiving dialysis treatment in Station 21. Patient’s access site was not visible. At 9:09 AM, Patient #11’s access site was still not visible. PCT 3 was observed at a supply station near Station 21. The technician failed to instruct Patient to keep their access site visible. b. At 8:42 AM, Patient #1 was receiving dialysis treatment in Station 20. Patient’s access site was not visible. c. At 8:46 AM, Patient #13 was receiving dialysis treatment in Station 17. PCT 5 was observed standing next to Station 17. The technician failed to instruct Patient to keep their access site visible. d. At 8:57 AM, PCT 1 and PCT 5 were observed at a supply station near Stations 17 and 20. Patient #13 and Patient #1’s access sites were not visible. The technicians failed to instruct the patients to keep their access sites visible. e. At 9:35 AM, Patient #1 and Patient #13’s access sites were not visible. 3. During an ICHD observation on 5/12/25 from 2:15 PM - 3:30 PM, the following was observed: a. At 2:15 PM, Patient #14 was receiving dialysis treatment in Station 23. Patient’s access was not visible. PCT 6 was observed at a supply station near Station 23. The technician failed to instruct Patient to keep their access site visible. b. At 2:57 PM, Patient #12 was observed receiving dialysis treatment in Station 20. Patient’s access was not visible. PCT 5 was observed at a supply station near Station 20. The technician failed to instruct Patient to keep their access site visible. 4. During an ICHD observation on 5/13/25 from 5:40 AM - 7:10 AM, the following was observed: a. At 6:22 AM, Patient #21 was receiving dialysis treatment in Station 14. Patient’s access was not visible. At 6:29 AM, PCT 1 and PCT 2 were observed at a supply station near Station 14. Patient’s access was not visible. The technicians failed to instruct Patient to keep their access visible. 5. During an ICHD observation on 5/13/25 from 9:23 AM - 10:57 AM, the following was observed: a. At 9:30 AM, Patient #25 was receiving dialysis treatment in Station 19. Patient’s access site was not visible. At 10:50 AM, Patient #25 was receiving dialysis treatment in Station 19. Patient’s access site remained not visible. b. At 10:08 AM, Patient #28 was receiving dialysis treatment in Station 2. Patient’s access site was not visible. PCT 3 took supplies into the station, placed them on the dialysis chair’s side table, then left the station. The technician failed to instruct Patient to keep their access site visible. c. At 10:52 AM, Patient #29 was receiving dialysis treatment in Station 11. Patient’s access site was not visible. PCT 1 walked by Station 11 but did not instruct Patient to keep their access site visible. 6. During an interview on 5/12/25 beginning at 3:12 PM, PCT 6 reported patient access sites should remain uncovered. The technician stated staff should perform access site checks every 30 minutes. 7. During an interview on 5/12/25 beginning at 3:21 PM, PCT 5 reported patient access sites should remain uncovered. The technician stated she was “always” watching patients to ensure their sites were visible and access checks should be documented every 30 minutes. 8. During an interview on 5/13/25 beginning at 9:47 AM, PCT 3 reported staff were “constantly watching” patients during treatment, and should monitor for access site visibility whenever staff “walk by” or were “around” a patient. 9. During an interview on 5/13/25 beginning at 3:16 PM, PCT 1 reported staff should perform access site checks every 30 minutes or when walking by patients to ensure access sites were visible. 10. Patient #1’s clinical record included treatment flowsheets between 4/30/25 - 5/12/25. The flowsheets evidenced on 5/09/25, Patient’s treatment began at 7:56 AM. The record failed to evidence access site checks were documented between 7:57 AM - 8:45 AM, which was 48 minutes between checks. During an interview on 5/16/25 beginning at 2:47 PM, PCT 3 reported access site checks should be performed and documented every 30 minutes. The technician was unsure of the reason no site checks were documented between 7:57 - 8:45 AM. 11. Patient #2’s clinical record included treatment flowsheets between 4/25/25 - 5/12/25. The flowsheets evidenced the following: a. On 4/25/25, Patient’s treatment began at 11:30 AM. The record failed to evidence access site checks were documented between 11:33 AM - 12:31 PM, which was 58 minutes between checks. b. On 5/02/25, Patient’s treatment began at 11:22 AM. The record failed to evidence access site checks were documented between 12:00 PM and 1:09 PM, which was 1 hour and 9 minutes between checks. During an interview on 5/15/25 beginning at 2:34 PM, PCT 5 reported access site checks should be performed and documented every 30 minutes. The technician stated she was likely on break on 4/25/25 and 5/02/25 when site checks were not documented. 12. Patient #3’s clinical record included a treatment flowsheet dated 5/02/25. The record failed to evidence access site checks were documented between 7:10 AM - 8:00 AM, which was 50 minutes between checks. During an interview on 5/16/25 beginning at 2:37 PM, PCT 2 reported access site checks should be documented every 30 minutes and she was likely on break when site checks were not documented. 13. Patient #5’s clinical record included a treatment flowsheet dated 5/07/25. The record failed to evidence access site checks were documented between 11:00 - 11:48 AM, which was 48 minutes between checks. During an interview on 5/19/24 beginning at 9:41 AM, PCT 4 was unsure of the reason Patient’s access site checks were not documented between 11:00 - 11:48 AM.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to administer medications to treat anemia according to its anemia management protocols, which resulted in the patient failing to achieve his/her goal hemoglobin level, for 1 of 2 ICHD records reviewed of patients not meeting anemia goals (Patient #1). Findings include: 1. The facility policy “CMAB Recommended Anemia Algorithm Venofer (InCenter) Version 4.0,” dated 7/08/19, indicated for patients new to dialysis, an Erythropoietin Stimulating Agent (ESA, a class of medications including Mircera used to treat anemia) was not to be started until the patient received a total of 1 gram (g) of iron (Venofer) in consecutive treatment doses (“Iron Series”). For patients with a Transferrin Saturation (TSAT, a laboratory test used to assess and treat low iron and/or anemia) result less than 30% and Ferritin (a laboratory test used to assess and treat low iron levels and/or anemia) less than 800 nanogram (ng) per milliliter (mL), an Iron Series consisting of 100 milligram (mg) iron administered for 10 consecutive treatments was to be administered. 2. The facility policy “Corporate MAB Recommended Anemia Algorithm Mircera [IV Push] Administration ...,” last revised 9/07/17, indicated patients new to dialysis with a hemoglobin level (laboratory test used to assess for anemia) less than 10.0 were to be started on Mircera once the patient received an Iron Series. 3. Patient #1’s clinical record evidenced an admission date of 3/11/25. A plan of care (POC) dated 4/23/25 evidenced an “Area of Focus” of “Anemia Management,” with a goal of a hemoglobin (Hgb) level of “10 - 11.” The POC indicated Patient had not met his/her goal. On 3/11/25, Patient’s Hgb was 11.4, TSAT was 14%, and Ferritin was 12 ng/mL. On 3/14/25, Corporate Employee 1 documented due to Patient’s 3/11/25 lab results, Patient was to begin receiving an Iron Series consisting of 100 mg Venofer three times a week for 10 doses. Patient did not need to begin Mircera due to his/her Hgb level. The record evidenced Patient received only one dose of Venofer between 3/15/25 - 4/05/25. On 4/07/25, Patient’s Hgb was 9.0. On 4/14/25, Patient’s Hgb was 9.7, TSAT was 15%, and Ferritin was 22 ng/mL. On 4/16/25, Corporate Employee 1 documented due to Patient’s lab results, Patient was to begin receiving an Iron Series consisting of 100 mg Venofer three times a week for 10 doses. Patient was not to begin Mircera until he/she had received the complete Iron Series. During an interview on 5/15/25 beginning at 11:48 AM, Corporate Employee 1 reported she would adjust patients’ Mircera and Venofer doses based on the facility’s anemia algorithms. Corporate Employee 1 reported Patient was unable to begin receiving doses of Mircera on 4/14/25 as Patient had not received a full Iron Series. The employee was unsure of the reason Patient did not receive the full Iron Series ordered to be administered 3/15/25 - 4/05/25. During an interview on 5/16/25 beginning at 2:59 PM, Charge Nurse 1 was unsure of the reason Patient did not receive the full Iron Series ordered to be administered between 3/15/25 - 4/05/25.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure the IDT noted trends and documented re-education for patients not documenting intra-dialysis vital signs for 1 of 2 HHD records reviewed (Patient #10) and failed to ensure the IDT noted trends and documented re-education for patients not documenting PD catheter site appearance for 2 of 3 PD records reviewed (Patients #6, 8). Findings include: 1. Patient #6’s clinical record evidenced Patient’s admission date was 7/20/20. Patient was to receive Continuous Cycling Peritoneal Dialysis (CCPD) through a PD catheter. Review of Patient’s PD flowsheets from 3/03/25 - 5/17/25 failed to evidence Patient documented the appearance of their PD catheter site, including if signs of infection, such as redness, drainage, and/or warmth was present. The record evidenced Patient went to the facility for a nurse visit on 4/02/25 and 5/05/25. The record failed to evidence the IDT noted and/or discussed the need to document the appearance of Patient’s PD catheter site daily. 2. Patient #8’s clinical record evidenced Patient’s admission date was 7/08/24. Patient was to receive CCPD daily through a PD catheter. Review of Patient’s PD flowsheets from 3/07/25 - 5/04/25 failed to evidence Patient documented the appearance of their peritoneal catheter site, including if signs of infection, such as redness, drainage, and/or warmth was present. The record evidenced Patient went to the facility for a nurse and/or IDT visit on 3/07/25, 3/18/25, 4/02/25, 4/22/25, 4/30/25, and 5/05/25. Patient reported symptoms of peritonitis on 4/30/25 with laboratory results confirming the infection. The record failed to evidence the IDT noted and/or discussed the need to document the appearance of Patient’s peritoneal catheter site daily. 3. During an interview on 5/19/25 beginning at 1:45 PM, Home Therapy Nurse 7 reported patients should be documenting the appearance of their PD catheter site daily. The nurse reported Patient #6 and Patient #8’s flowsheets failed to evidence the patients were documenting the appearance of their PD catheter site daily. 4. Patient #10’s clinical record evidenced Patient transferred from an outside hemodialysis facility to Fresenius Medical Care Kokomo on 1/23/25. Patient performed his/her hemodialysis at home and did not have a caregiver assisting with the treatment. Review of Patient’s HHD flowsheets from 3/31/25 - 4/17/25 failed to evidence Patient documented vital sign and access checks every 30 minutes. During an observation of a HHD clinic visit on 5/12/25 beginning at 12:22 PM, the facility’s IDT, including Medical Director, Home Therapy Manager 4, LPN 4, Social Worker 1, Dietitian 1, and PCT 8 met with Patient. Medical Director and LPN 4 reviewed Patient’s HHD flowsheet summary. During the clinic visit, the IDT failed to note and/or discuss the need to document vital signs and access checks every 30 minutes with Patient. During an interview on 5/19/25 beginning at 3:20 PM, Home Therapy Manager 4 reported HHD patients were to document vital signs every 30 minutes during treatment.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 42617 Based on QAPI minute review, policy review, and interview, the dialysis facility failed to review and evaluate all ICHD patient deaths to identify potential trends, which had the potential to affect 76 active ICHD patients. Findings include: 1. The facility policy “Quality Assessment and Performance Improvement Program,” dated 11/04/24, indicated the dialysis facility’s QAPI committee would “monitor data/information ... determine potential root causes ....” Data to be reviewed included but was not limited to “patient care outcomes ... medical records ....” The QAPI committee was also to identify “commonalities, circumstances, conditions, or barriers that are impacting quality improvement and facility indicators.” 2. The review of the agency’s QAPI meeting minutes analyzing October 2024 - February 2025 data evidenced the following: a. The QAPI meeting held 11/27/24, analyzing October 2024 data, evidenced three ICHD patients had died. The QAPI minutes failed to evidence all patient deaths were evaluated to identify potential trends in causes and/or contributing factors. b. The QAPI meeting held 12/17/24, analyzing November 2024 data, evidenced one ICHD patient had died. The QAPI minutes failed to evidence all patient deaths were evaluated to identify potential trends in causes and/or contributing factors. c. The QAPI meeting held 1/22/25, analyzing December 2024 data, evidenced one ICHD patient had died. The QAPI minutes failed to evidence all patient deaths were evaluated to identify potential trends in causes and/or contributing factors. d. The QAPI meeting held 2/19/25, analyzing January 2025 data, evidenced one ICHD had died. The QAPI minutes failed to evidence all patient deaths were evaluated to identify potential trends in causes and/or contributing factors. e. The QAPI meeting held 3/26/25, analyzing February 2025 data, evidenced three ICHD had died. The QAPI minutes failed to evidence all patient deaths were evaluated to identify potential trends in causes and/or contributing factors. During an interview on 5/19/25 at 5:15 PM, Administrator reported the QAPI committee tracked and analyzed only the number of patient deaths. The QAPI committee did not review the cause of death nor contributing factors.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 42617 Based on QAPI documentation, policy review, and interview, the dialysis facility failed to ensure its QAPI program identified low vaccination rates among its ICHD patients and developed action plans to promote immunization, which had the potential to affect 76 active ICHD patients. Findings include: 1. The facility policy “Quality Assessment and Performance Improvement Program,” dated 11/04/24, indicated the dialysis facility’s QAPI committee would “monitor data/information ... develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care ....” Data to be reviewed included but was not limited to “patient care outcomes. Infection surveillance ... medical records ....” The QAPI committee was also to prioritize identified opportunities for improvement and develop action plans for identified problems. 2. The review of the agency’s QAPI meeting minutes analyzing October 2024 - March 2025 data evidenced the following: a. The QAPI meeting held 11/27/24, analyzing October 2024 data, evidenced: i. The facility had received the flu vaccine and “started to discuss and administer the flu shot.” ii. 38.5% of ICHD patients had received a pneumonia vaccine. 20 patients needed to be offered the vaccine. b. The QAPI meeting held 12/17/24, analyzing November 2024 data, evidenced: i. 41% of ICHD patients had received a flu vaccine and 37 patients needed to be offered the vaccine. ii. 39.2% of ICHD patients had received a pneumonia vaccine. 17 patients needed to be offered the vaccine. c. The QAPI meeting held 1/22/25, analyzing December 2024 data, evidenced: i. 44% of ICHD patients had received a flu vaccine. 34 patients needed to be offered the vaccine. ii. 43.8% of ICHD patients had received a pneumonia vaccine. 15 patients needed to be offered the vaccine. d. The QAPI meeting held 2/19/25, analyzing January 2025 data, evidenced: i. 42% of ICHD patients had received a flu vaccine. 34 patients needed to be offered the vaccine. ii. 43.1% of ICHD patients had received a pneumonia vaccine. 15 patients needed to be offered the vaccine. e. The QAPI meeting held 3/26/25, analyzing February 2025 data, evidenced: i. 45% of ICHD patient had received a flu vaccine. 32 patients needed to be offered the vaccine. ii. 44.3% of ICHD patients had received a pneumonia vaccine. 15 patients needed to be offered the vaccine. f. The QAPI meeting held 4/23/25, analyzing March 2025 data, evidenced: i. 43% of ICHD patients had received a flu vaccine. 36 patients needed to be offered the vaccine. ii. 40.8% of ICHD patients had received a pneumonia vaccine. 19 patients needed to be offered the vaccine. During an interview on 5/19/25 at 5:15 PM, Administrator reported the facility had been tracking its ICHD patient vaccination rates, but had not created any formal action plans to address the low flu and pneumonia vaccination rates.”

“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: 42617 Based on observation, record review, and interview, the medical director failed to ensure policies were followed specific to medication labeling and storage for 2 of 2 days of ICHD treatment floor observations, fistula access site disinfection for 1 of 2 observations of ICHD fistula cannulation (Patient #16), patient monitoring and reporting of abnormal vital signs and/or weights for 6 of 6 ICHD records reviewed (Patients #1, 2, 3, 4, 5, 10). Findings include: 1. The facility policy “Medication Preparation and Administration”, dated 2/06/23, indicated all medications were to be kept in a locked cabinet except when in use. Any open multi-dose vial not used immediately must be labeled with the date the vial was opened. 2. The facility policy “Access Assessment and Cannulation,” dated 5/05/25, indicated after evaluating a fistula, staff should apply antiseptic to disinfect the cannulation sites. Staff were not to touch the cannulation sites after disinfection. 3. The facility policy “Nursing Supervision and Delegation”, dated 11/06/23, indicated the RN must evaluate each patient within an hour of treatment initiation to “review accuracy and completeness of treatment and patient data ... Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed.” PCTs were to report the following to the nurse for further assessment: a. Any post treatment weight more than 1.0 kilogram (kg) above the Estimated Dry Weight (EDW, the weight a patient is ordered to be at after dialysis had removed excess fluid from the body) b. A systolic (SBP, top number in a BP reading) reading greater than 180 millimeters of mercury (mmHg) at any time before, during, or after treatment c. A diastolic (DBP, bottom number in a BP reading) reading greater than 100 mmHg at any time before, during, or after treatment d. A drop in SBP of 20 mmHg between sitting and standing 4. The facility policy “Patient Assessment and Monitoring,” dated 5/01/23, indicated pre-treatment, staff were to verify SBP greater than 180 mmHg and DBP greater than 100 mmHg. During treatment, staff were to report the following to the nurse: a. SBP greater than 180 mmHg or less than 100 mmHg b. DBP greater than 100 mmHg c. Heart rates (HR) less than 60 or greater than 100. The policy also indicated a patient’s BP and HR were to be obtained “every 30 minutes or more as needed but not to exceed 45 minutes.” 5. The facility policy “Guidelines for Recognizing and Treating Orthostatic (Postural) Hypotension,” dated 2/07/22, defined orthostatic hypotension as “a drop in blood pressure from sitting to standing that is equal to or greater than 20 mmHg systolic or 10 mmHg diastolic.” If a patient exhibited signs or symptoms of orthostatic hypotension, staff were to place the patient in modified Trendelenburg position (on the back with the legs elevated), recheck the patient’s vital signs, and administer normal saline in bolus doses of 100 - 200 milliliters (ml). Patients were to be re-assessed after 10-15 minutes, and the physician was to be notified if signs and symptoms of orthostatic hypotension continued. 6. During an ICHD flash tour observation on 5/12/25 beginning at 8:38 AM, four vials of Heparin (a medication used to thin the blood) were observed unsecured on a counter. One bottle of Calcitrol (medication used to treat low calcium levels), one bottle of Cinacalcet (medication used to treat an elevated parathyroid level), one vial of Heparin (a blood thinner), and one bottle of Midodrine (a medication used to treat low blood pressure) were observed open without a label indicating the date the bottles/vial were opened. During an interview on 5/12/25 beginning at 9:30 AM, Charge Nurse reported multi-use medication bottles and vials should be labeled with the date the bottle/vial was opened. 7. During an ICHD floor observation on 5/13/25 from 5:40 AM - 7:10 AM, four vials of Heparin were observed unsecured on a counter. During an interview on 5/13/25 beginning at 3:19 PM, Charge Nurse 1 was unsure how the Heparin vials were kept secured when stored on the counter. 8. During an ICHD treatment floor observation on 5/12/25 beginning at 11:19 AM, PCT 4 was in Station 12 cannulating Patient #16’s fistula. After applying antiseptic to the second cannulation site, PCT 4 re-evaluated the access site by palpating with her fingers. The technician then cannulated the second fistula site, failing to re-apply antiseptic prior to cannulation. During an interview on 5/12/25 beginning at 2:19 PM, PCT 4 reported when cannulating a fistula, antiseptic should be re-applied if the site needed to be re-evaluated after it was disinfected. 9. Patient #1’s clinical record evidenced the Dialysate Flow Rate (DFR) was ordered to be 800 milliliters per minute (ml/min). Treatment flowsheets reviewed between 4/30/25 - 5/12/25 evidenced the following: a. On 4/30/25, Patient’s post-treatment sitting BP was 163/85 and standing BP was 139/76, a decrease by 24 mmHg. The record failed to evidence the nurse was notified nor did the facility enact any interventions to address orthostatic hypotension according to its policy. b. On 5/02/25, Patient’s post-treatment sitting BP was 146/84 and standing BP was 119/67, a decrease by 27 mmHg. The record failed to evidence the nurse was notified nor did the facility enact any interventions to address orthostatic hypotension according to its policy. c. On 5/05/25, Patient’s treatment began at 7:55 AM. At 11:53 AM, Patient’s heart rate was 103. Patient’s treatment ended at 11:54 AM. Patient’s post-treatment heart rate was 107, sitting BP was 139/68, and standing BP was 115/65. Patient’s BP dropped by 24 mmHg. The record failed to evidence the nurse was notified of Patient’s elevated HR or drop in BP, and failed to evidence the facility enacted interventions to address Patient’s orthostatic hypotension according to its policy. During an interview on 5/15/25 beginning at 2:24 PM, PCT 4 reported she would not report a drop in SBP at the end of treatment. The technician stated she would only report if the SBP was less than 100 mmHg. PCT 4 reported a HR above 100 or below 60 should be reported to the nurse. The PCT was unsure if Patient’s post-treatment elevated HR was reported to the nurse. d. On 5/07/25, Patient’s pre-treatment sitting BP was 128/84 and standing BP was 103/71, a drop by 25 mmHg. Patient’s treatment began at 7:52 AM. At 11:01 AM, Patient’s DFR was noted to be 500 milliliters per minute (ml/min). The DFR remained at 500 ml/min until Patient’s treatment ended at 11:52 AM. The record failed to evidence the nurse was notified of Patient’s drop in BP and failed to evidence the reason Patient’s DFR was not followed according to physician order. During an interview on 5/15/25 beginning at 3:08 PM, PCT 7 was unsure Patient’s DFR was not run according to physician orders. e. On 5/09/25, Patient’s treatment began at 7:56 AM. The record failed to evidence vital signs were documented between 7:57 AM - 8:45 AM, which was 48 minutes between vital sign checks. Patient’s nurse assessment was documented at 9:55 AM, which was 1 hour and 59 minutes after Patient’s treatment began. Patient’s post-treatment sitting BP was 146/72 and standing BP was 124/66, a drop in 22 mmHg. During an interview on 5/15/25 beginning at 2:57 PM, RN 2 reported she tried to assess all patients within one hour of treatment start. The nurse was unsure of the reason Patient’s nurse assessment was documented 1 hour and 59 minutes into treatment, but stated she was likely the only nurse on the treatment floor at the time. RN 2 reported PCTs should report a decrease by 30 mmHg from sitting to standing SBP. During an interview on 5/16/25 beginning at 2:47 PM, PCT 3 reported vital signs should be performed and documented every 30 minutes. The technician was unsure of the reason vital signs were not documented between 7:57 - 8:45 AM. During an interview on 5/15/25 beginning at 2:34 PM, PCT 5 stated she would report a decrease by 30 mmHg from sitting to standing SBP. The technician referenced an undated document taped to a medication cabinet titled “Reporting to the RN,” which indicated PCTs should report a decrease by 30 mmHg from sitting to standing SBP. During an interview on 5/15/25 beginning at 4:30 PM, Administrator reported the “Reporting to the RN” document was outdated, and staff should follow the facility policies for reporting a drop in SBP from sitting to standing. 10. Patient #2’s clinical record evidenced a physician-ordered Blood Flow Rate (BFR) of 400 ml/min, Estimated Dry Weight (EDW) of 98.0 kilograms (kg), and special attention order of “ok to run [Patient] with low BP readings if patient asymptomatic.” Treatment flowsheets reviewed between 4/25/25 - 5/12/25 evidenced the following: a. On 4/25/25, Patient’s record failed to evidence a pre-treatment standing BP was obtained. A nurse assessment indicated Patient was ambulatory. Patient’s treatment began at 11:30 AM. The record failed to evidence vital signs were documented between 11:33 AM - 12:31 PM, which was 58 minutes between checks. Patient’s BPs during treatment included: i. At 11:33 AM, BP was 93/75 ii. At 1:02 PM, BP was 89/46 iii. At 1:33 PM, BP was 90/29 iv. At 2:41 PM, BP was 82/47. The record failed to evidence Patient was evaluated for symptoms of low blood pressure. Patient’s post-treatment weight was 100 kg, which was 2.0 kg above Patient’s EDW. The record failed to evidence Patient’s physician was notified of the post-treatment weight more than 1 kg above the EDW. b. On 4/28/25, Patient’s record failed to evidence a pre-treatment standing BP was obtained. A nurse assessment indicated Patient was ambulatory. Patient’s BP during treatment included: i. At 11:34 AM, BP was 92/79 ii. At 12:02 PM, BP was 83/45 iii. At 1:12 PM, BP was 140/113 iv. At 2:06 PM, BP was 147/104 and 147/114 The record failed to evidence Patient was evaluated for symptoms of low BP and failed to evidence the nurse was notified of a diastolic BP above 100. During an interview on 5/15/25 beginning at 3:08 PM, PCT 7 reported a DBP greater than 100 should be reported to the nurse. He was unsure if Patient’s elevated DBP was reported. PCT also reported all ambulatory patients should have a standing BP documented prior to start of treatment. c. On 5/02/25, Patient’s record failed to evidence a pre-treatment standing BP was obtained. A nurse assessment indicated Patient was ambulatory. The record failed to evidence vital signs were documented between 12:00 PM and 1:09 PM, which was 1 hour and 9 minutes between checks. Patient’s BP during treatment included: i. At 11:23 AM, BP was 97/85 ii. At 12:00 PM, BP was 92/45 and 82/57 iii. At 1:31 PM, BP was 89/53 iv. At 2:03 PM, BP was 87/78 The record failed to evidence Patient was evaluated for symptoms of low BP. d. On 5/05/25, Patient’s record evidenced the following vital signs: i. At 12:04 PM, BP was 165/102 and HR was 47 ii. At 12:32 PM, HR was 49 iii. At 1:35 PM, HR was 52 iv. At 2:32 PM, HR was 48 The record failed to evidence the nurse was notified of the low heart rate and elevated diastolic BP. During an interview on 5/15/25 beginning at 2:24 PM, PCT 4 reported a heart rate less than 60 and a DPB above 100 should be reported to the nurse. The technician thought Patient had a standing order for his/her HR to run lower than 60, and reported the nurse notification of Patient’s elevated DBP was not documented. e. On 5/09/25, Patient’s record failed to evidence a pre-treatment standing BP was obtained. A nurse assessment indicated Patient was ambulatory, patient lung sounds were clear, and no shortness of breath was documented. Patient’s vital signs during treatment included: i. At 11:21 AM, BP was 131/107. The record failed to evidence the nurse was notified of the elevated diastolic BP. During an interview on 5/15/25 beginning at 2:57 PM, RN 2 stated the reporting of a post-treatment weight to the MD was patient-specific and depended on the patient’s trends, but generally would report a post-treatment weight which was “4-5 kg” above the EDW. RN 2 stated she would not have reported Patient’s post-treatment weight of 2.0 kg above the EDW on 4/25/25. The nurse reported a PCT should report a SBP “trending up” above 180 mmHg, “trending down” below 90 mmHg, DBP above 100 or below 50 mmHg. RN 2 stated Patient’s standing order to dialyze with low SBPs was not specific. The nurse stated staff should be documenting that Patient was asymptomatic when his/her SBP was low. During an interview on 5/19/25 beginning at 9:05 AM, PCT 3 reported standing BPs were to be performed prior to treatment initiation. The technician stated many patients were short of breath at the beginning of treatment and would not get up to obtain a standing BP. The technician reported this should be documented as “patient refused.” During an interview on 5/15/25 beginning at 2:34 PM, PCT 5 reported vital signs should be obtained and documented every 30 minutes. The technician stated she was likely on break on 4/25/25 and 5/02/25 when vital signs were not documented. PCT 5 reported patients will often “plop down” in the chair at the beginning of treatment, and staff do not always ask the patient to stand to obtain a standing BP. The technician also stated Patient’s SBP typically ran low during treatment, and was “generally ok” if the SBP was “70s - 80s.” PCT 5 stated she didn’t always document if Patient was asymptomatic. 11. Patient #3’s clinical record evidenced orders to administer Clonidine (a medication used to treat elevated BP) as needed for a SBP greater than 180 and administer 100 mL saline flush every 30 minutes during treatment in order to prevent clotting as Patient was allergic to Heparin. Treatment flowsheets reviewed between 4/30/25 - 5/12/25 evidenced the following: a. On 4/30/25, Patient’s pre-treatment BP was 215/98 sitting and 233/98 standing. Patient’s treatment started at 6:50 AM. Patient’s BP during treatment included: i. At 6:51 AM, BP was 232/94 ii. At 7:31 AM, BP was 232/94 iii. At 8:01 AM, BP was 208/89 iv. At 8:35 AM, BP was 222/95 v. At 9:01 AM, BP was 197/82 vi. At 9:33 AM, BP was 208/91 vii. At 10:14 AM, BP was 194/89 Patient’s post-treatment BP was 207/81 sitting and 193/89 standing. The record failed to evidence the nurse was notified of Patient’s elevated BPs before, during, and after treatment, failed to evidence Clonidine was administered per order, and failed to evidence saline flushes were administered per order. During an interview on 5/19/24 beginning at 9:41 AM, PCT 4 reported whether an elevated SBP was reported to the nurse was patient-specific. She would generally report an elevated SBP to the nurse if the number was “in red” on the EMR. The technician reported Patient’s BP “runs high” and the nurse notification should be documented in the record. PCT 4 was not aware Patient had an order to administer saline flushes every 30 minutes. b. On 5/02/25, Patient’s treatment began at 7:09 AM. The record failed to evidence vital signs were documented between 7:10 AM - 8:00 AM, which was 50 minutes between checks. A nurse assessment was documented at 8:14 AM, which was one hour and five minutes after Patient’s treatment began. The record failed to evidence saline flushes were administered per order. During an interview on 5/16/25 beginning at 2:37 PM, PCT 2 reported a SBP above 180 mmHg should be reported to the nurse. The technician stated vital signs should be documented every 30 minutes and she was likely on break during the time no vital sign checks were documented. PCT 2 reported saline flushes were only administered for Patient on an as-needed basis. During an interview on 5/19/25 beginning at 3:02 PM, Charge Nurse 1 reported the nurse assessment should be documented within one hour of the start of treatment. The nurse was unsure of the reason Patient’s nurse assessment was documented late. c. On 5/05/25, Patient’s pre-treatment sitting BP was 194/80 and standing BP was 101/72, a drop of 93 mmHG. The record failed to evidence the nurse was notified of the drop in SBP nor did the facility enact any interventions to address orthostatic hypotension according to its policy, and failed to evidence saline flushes were administered per order. During an interview on 5/16/25 beginning at 2:37 PM, PCT reported a drop in SBP by 20 mmHg should be reported to the nurse. The PCT stated the nurse notification was not documented on 5/05/25. d. On 5/07/25, Patient had a pre-treatment standing BP documented. A nurse assessment indicated Patient was ambulatory. The record failed to evidence a post-treatment standing BP was performed and failed to evidence saline flushes were administered per order. During an interview on 5/19/25 beginning at 9:24 AM, PCT 2 reported standing BPs were to be obtained after a patient completed treatment. The technician reported Patient would intermittently leave the facility by wheelchair. PCT 2 stated this was not documented in the treatment flowsheet. e. On 5/09/25, Patient’s BPs during treatment included: i. At 7:14 AM, BP was 188/81 ii. At 9:06 AM, BP was 136/109 iii. At 10:02 AM, BP was 192/85 iv. At 10:31 AM, BP was 202/86 v. At 11:05 AM, BP was 192/85 vi. At 11:12 AM, BP was 188/78 Patient’s post-treatment BP was 188/78 sitting and 197/83 standing. The record failed to evidence the nurse was notified of Patient’s elevated BPs during and after treatment, failed to evidence Clonidine was administered per order, and failed to evidence saline flushes were administered per order. During an interview on 5/16/25 beginning at 2:17 PM, PCT 7 reported a SBP above 180 should be reported to the nurse. The PCT was unsure of the reason Patient’s elevated SBP was not documented as reported. PCT 7 was unaware Patient had orders for saline flushes to be administered every 30 minutes. f. On 5/12/25, the record failed to evidence saline flushes were administered per order. During an interview on 5/16/25 beginning at 3:11 PM, Charge Nurse 1 reported Patient had no “special attention” orders indicating it was ok for Patient’s BP to be elevated, therefore PCTs should notify the nurse of a SBP above 180 mmHg. Charge Nurse 1 reported the nurse should administer Clonidine for Patient’s SBP above 180 mmHg. The nurse was unsure of the reason Patient did not receive Clonidine on 4/30/25 or 5/09/25. Charge Nurse 1 reported staff should be administering saline flushes every 30 minutes per standing order. 12. Patient #4’s clinical record included orders for a DFR of 800 ml/min. Treatment flowsheets between 4/30/25 - 5/12/25 were reviewed and evidenced: a. On 5/05/25, Patient’s DFR throughout treatment was 500 ml/min. Patient’s HR during treatment included: i. At 1:03 PM, HR was 50 ii. At 2:07 PM, HR was 53 iii. At 2:16 PM, HR was 49 iv. At 2:03 PM, HR was 56 v. At 3:09 PM, HR was 56 vi. At 3:31 PM, HR was 53 The record failed to evidence the nurse was notified of Patient’s low HR. During an interview on 5/19/25 beginning at 9:24 AM, PCT 2 stated she would report a HR less than 60 to a nurse. The technician thought Patient had a special attention order indicating it was ok for Patient’s heart rate to be less than 60. The technician was unsure of the reason Patient’s DFR was not run according to the prescribed rate, but stated it could have been a conductivity or machine issue. During an interview on 5/19/25 beginning at 9:41 AM, PCT 4 stated she would report a HR less than 50 to a nurse. The technician was unsure of the reason Patient’s DFR was not run according to the prescribed rate, but stated it could have been an issue with the bicarbonate bag attached to the machine. b. On 5/09/25, Patient’s HR prior to treatment was 56. Patient’s HR during treatment included: i. At 11:55 AM, HR was 51 ii. At 12:31 PM, HR was 55 iii. At 1:12 PM, HR was 53 iv. At 2:01 PM, HR was 53 v. At 2:31 PM, HR was 53 vi. At 3:02 PM, HR was 57 The record failed to evidence the nurse was notified of Patient’s low HR. During an interview on 5/19/25 beginning at 9:19 AM, PCT 5 reported she would have reported Patient’s low HR to the nurse. The technician reported she may have forgotten or gotten busy and did not document reporting the low HR. 13. Patient #5’s clinical record included flowsheets between 4/30/25 - 5/12/25 which evidenced: a. On 4/30/25, Patient’s vital signs during treatment included: i. At 1:03 PM, BP was 180/83 and HR was 106 ii. At 1:31 PM, HR was 105 iii. At 2:01 PM, HR was 116 The record failed to evidence the nurse was notified of the elevated BP and HR. b. On 5/05/25, Patient’s treatment began at 10:55 AM. A nurse assessment was documented at 12:14 PM, which was one hour and 19 minutes after start of treatment. Patient’s HR during treatment included: i. At 1:02 PM, HR was 105 ii. At 1:33 PM, HR was 103 During an interview on 5/19/25 beginning at 9:15 AM, RN 2 reported the nurse assessment may be documented late due to only having one nurse on the treatment floor at the time. c. On 5/07/25, Patient’s treatment began at 10:36 AM. The record failed to evidence vital signs were documented between 11:00 - 11:48 AM, which was 48 minutes between checks. At 12:32 PM, Patient’s HR was 113. The record failed to evidence the nurse was notified of the elevated HR. During an interview on 5/19/24 beginning at 9:41 AM, PCT 4 reported whether an elevated SBP or HR was reported to the nurse was patient-specific. She would generally report an elevated SBP or HR to the nurse if the number was “in red” on the EMR. PCT 4 she would document in the EMR when the nurse was notified. The technician was unsure of the reason Patient’s vital signs were not done between 11:00 - 11:48 AM. 14. Patient #10’s clinical record evidenced Patient transferred from an outside hemodialysis facility to Fresenius Medical Care Kokomo on 1/23/25. Patient received respite ICHD from 4/22/25 - 5/03/25. Patient’s ordered EDW was 88.0 kg. The ICHD flowsheets evidenced: a. On 4/22/25, Patient’s nursing assessment evidenced Patient was dyspneic, had decreased breath sounds and wheezing, and pitting edema (swelling which causes an indentation when pressed, graded on a scale of 1+ to 4+, with 1+ edema evidencing a small indentation which disappears quickly and 4+ evidencing a very deep pit which takes more than one minute to disappear) of 2+ in the left ankle and 1+ in the left lower leg. Patient’s post-treatment weight was 90.0 kg. The record failed to evidence the physician was notified Patient’s post-treatment weight was 2.0 kg above EDW with signs of fluid overload. b. On 4/24/25, Patient’s nursing assessment evidenced Patient was dyspneic and pitting edema of 2+ in both ankles and lower legs. Patient’s post-treatment weight was 89.6 kg. The record failed to evidence the physician was notified Patient’s post-treatment weight was 1.6 kg above EDW with signs of fluid overload. c. On 4/26/25, Patient’s nursing assessment evidenced Patient had pitting edema of 1+ in both ankles and lower legs. Patient’s post-treatment weight was 91.5 kg. The record failed to evidence the physician was notified Patient’s post-treatment weight was 3.5 kg above EDW with signs of fluid overload. d. On 4/29/25, Patient’s nursing assessment evidenced Patient had pitting edema of 1+ in both ankles and lower legs. Patient’s post-treatment weight was 91.5 kg. The record failed to evidence the physician was notified Patient’s post-treatment weight was 3.1 kg above EDW with signs of fluid overload. e. On 5/01/25, Patient’s nursing assessment evidenced Patient had pitting edema of 3+ to both ankles and 2+ to both lower legs. Patient’s post-treatment weight was 90.0 kg. The record failed to evidence the physician was notified Patient’s post-treatment weight was 2.0 kg above EDW with signs of fluid overload. f. On 5/03/25, Patient’s nursing assessment evidenced Patient had pitting edema of 3+ to both ankles and lower legs. Patient’s post-treatment weight was 91.1 kg. The record failed to evidence the physician was notified Patient’s post-treatment weight was 3.1 kg above EDW with signs of fluid overload. During an interview on 5/19/25 beginning at 9:34 AM, RN 2 stated she did not recall reporting Patient’s post-treatment weights above the EDW to the physician. During an interview on 5/19/25 beginning at 3:02 PM, Charge Nurse 1 reported he would report a post-treatment weight four kg or higher than the EDW to the MD. The nurse stated a post-treatment weight above the EDW should be reported to the physician if the patient was exhibiting signs and/or symptoms of fluid overload. Charge Nurse 1 stated he would document the MD notification if orders were received. 15. During an interview on 5/13/25 beginning at 3:19 PM, Charge Nurse 1 reported vital signs should be documented every 30 minutes. During an interview on 5/16/25 beginning at 2:59 PM, Charge Nurse 1 reported PCTs should report a SBP greater than 180 or less than 100, a DBP greater than 100, a HR greater than 100 or less than 60, and a drop in SBP of 20 or more mmHg. Charge Nurse 1 reported staff should document vital sign and access checks every 30 minutes. Standing blood pressures should be obtained for all ambulatory patients. 16. During an interview on 5/15/25 beginning at 11:24 AM, Medical Director reported the PCT should report a drop in SBP of more than 20 mmHg from sitting to standing and the patient should be assessed for presence or absence of symptoms of orthostatic hypotension, as patients may need to receive a fluid infusion or have other interventions. The physician also stated the PCT should report a SBP less than 100 mmHg and greater than 150 - 160 mmHg to the nurse.”