Every finding on record at VNA of the Wabash Valley Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR §484.102 Survey Dates: 05/12/2026 to 05/15/2026 Active Census:202 At this Emergency Preparedness survey, Visiting Nurse Association of the Wabash Valley IN was found to be in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR §484.102. QR Completed on 05/22/2026 by A4JG

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: 05/12/2026 to 05/15/2026 12-Month Unduplicated Skilled Admissions: 1147 Partially Extended on 05/13/2026 at 4:30 PM. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Abbreviations: HHA - Home Health Aide LPN- Licensed Practical Nurse POC- Plan of Care RN- Registered Nurse

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to have a signed POC or a valid verbal POC order including the physician’s name, the date and time of the verbal order, the specific services and treatments authorized, and the name and title of the staff member receiving the order from the primary physician before providing services and treatments to patients in 9 of 17 record reviews, potentially affecting all patient records. (Patients #5, #8, #9, #10, #11, #12, #13, #14, #16) Findings include: 1. A review of Patient #5's record for the certification period 05/07/2026 to 07/05/2026 evidenced a Communication Note dated 05/04/2026 indicating the agency received a verbal start of care from the physician. The agency provided skilled nursing services on 05/12/2026 and 05/14/2026 without obtaining a valid verbal order or a signed POC from the physician. 2. A review of Patient #8's record for the certification period 04/06/2026 to 06/04/2026 evidenced a Communication Note dated 04/03/2026 indicating the agency received a verbal start of care from the physician. The agency provided skilled nursing services on 04/08/2026, 04/14/2026, 04/17/2026, 04/20/2026, 04/22/2026, 04/24/2026, 04/29/2026, 05/01/2026, and 05/04/2026 without obtaining a valid verbal order or a signed POC from the physician. 3. A review of Patient #9's record for the certification period 03/24/2026 to 05/22/2026 evidenced a Communication Note dated 03/11/2026 indicating the agency received a verbal start of care from the physician. The agency provided skilled nursing services on 03/26/2026, 03/30/2026, 04/02/2026, 0406/2026, and 04/10/2026 without obtaining a valid verbal order or a signed POC from the physician. 4. A review of Patient #10's record for the certification period 04/17/2026 to 06/15/2026 evidenced a Communication Note dated 04/15/2026 indicating the agency received a verbal start of care from the physician. The agency provided skilled nursing services on 04/21/2026, 04/28/2026, 05/04/2026; provided HHA services on 04/24/2026, 04/28/2026, and 04/30/2026 without obtaining a valid verbal order or a signed POC from the physician. 5. A review of Patient 11's record for the certification period 04/05/2026 to 06/03/2026 evidenced a Communication Note dated 04/30/2026 indicating the agency received a verbal start of care from the physician. The agency provided and skilled nursing services on 04/09/2026, 04/16/2026, 04/23/2026, 04/30/2026 and 05/07/2026 without obtaining a valid verbal order or a signed POC from the physician. 6. A review of Patient #12's record for the certification period 04/04/2026 to 06/02/2026 evidenced a Communication Note dated 03/31/2026 indicating the agency received a verbal start of care from the physician. The agency provided OT services on 04/08/2026, 04/10/2026, 04/21/2026, 04/23/2026, and 04/29/2026 without obtaining a valid verbal order or a signed POC from the physician. 7. A review of Patient #13's record for the certification period 12/18/2025 to 02/15/2026 evidenced a Communication Note dated 12/11/2025 indicating the agency received a verbal start of care from the physician. The agency provided skilled nursing services on 12/23/2025 and 12/30/2025 without obtaining a valid verbal order or a signed POC from the physician. 8. A review of Patient 14's record for the certification period 01/28/2025 to 03/28/2025 evidenced a Communication Note dated 01/27/2025 indicating the agency received a verbal start of care from the physician. The agency provided and skilled nursing services on 02/04/2025, 02/10/2025, 02/23/2025, 02/27/2025, 03/03/2025, 03/05/2025, 03/10/2025, 03/12/2025,03/17/2025, and 03/19/2025 without obtaining valid verbal order or a signed POC from the physician. 9. A review of Patient #16's record for the certification period 01/12/2026 to 03/12/2026 evidenced a Communication Note dated 01/09/2026 indicating the agency received a verbal start of care from the physician. The agency provided PT services on 01/16/2026, 01/21/2026 and OT services on 01/22/2026 without obtaining a valid verbal order or a signed POC from the physician. 410 IAC 17-13-1(a)

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide the patient with a copy of the aide POC in the home for 1 of 1 non-skilled patient home visits. (Patient #10) Findings include: During a home visit conducted on 05/14/2026 at 3:00 PM, the surveyor reviewed Patient #10’s admission packet. The packet did not contain a copy of the aide POC, as required. During an interview on 05/14/2026 at 3:10 PM, HHA 1 stated Patient #10 did not have a copy of the aide POC in the home. During an interview on 05/14/2026 at 3:30 PM, the Alternate Administrator stated the agency did not provide a copy of the aide POC in the home.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to adhere to infection control procedures for 4 of 6 skilled patient home visits. (Patients #2, #3, #5, #8) Findings included: 2. During an observation on 05/12/2026 at 12:05 PM, RN 3 removed stethoscope from around neck, listened to Patient #3's lungs then placed stethoscope back around her neck. RN 3 failed to clean stethoscope before and after use on Patient #3. RN 3 scrunched up dirty drape in left hand, holding it with her last 3 fingers, while using her thumb and first finger to do a head to toe assessment on Patient #3. RN failed to dispose of dirty supplies, glove change and hand hygiene after touching dirty drape and before touching patient. RN 3 gloved, then touched Patient #3's G-tube insertion site. RN 3 failed to hand hygiene before gloving. During an interview on 05/12/2026 at 1:00 PM, RN 3 indicates hand hygiene is to be completed before and after glove change, she indicated she knew she missed some infections control during the home visit. 3. During an observations on 05/12/2025 at 2:57 with Clinical Supervisor present, LPN 1 cleaned skin on Patient #5's right AC touched skin with gloves finger then pierced skin with a butterfly needle. LPN 1 rolled used needle up in glove, LPN 1 second attempt for labs, LPN 1 held lab tube in mouth while attempting to collect lab in right forearm, removed tube from mouth, attached to a vacutainer. Then LPN 1 provided Patient #5 family member with a syringe and needle to attempt to collect labs from right AC; family member palpated site, punctured skin using needle/syringe provided by LPN 1. LPN 1's third attempt for labs, LPN 1 healed lab tube in mouth while attempting to collect lab in right hand. LPN 1 touched skin then pierced skin with butterfly. LPN 1 removed lab tube from mouth, laying on patient chair. LPN 1 then removed right glove, entered nursing bag collected needle from nursing bag, used bare hand to remove butterfly needle from syringe and connected new needle to syringe. LPN 1 rolled butterfly needle, syringe and capped needle used during third attempt into used left glove. LPN 1 told patient/family member she has sharps container in car. LPN 1 then returned clean equipment in nursing bag without hand hygiene before touching clean equipment. LPN 1 and family member failed to hand hygiene before and after gloving, clean access site after touching and before piercing skin with needle; LPN 1 failed to properly discard biohazard material, failed to keep clean lab equipment from contacting LPN 1's body fluids, failed to hand hygiene before entering nursing bag, and failed to don gloves before touching blood contaminated lab equipment. During an interview on 05/12/2026 at 4:15 PM, the Clinical Supervisor indicated lab tubes are not to be placed in clinicians mouth, family members are not allowed to draw labs for agency, there was hand hygiene and infection control concerns that she noted during visit. 2. During an observation on 05/12/2026 at 1:30 PM, the surveyor observed an ant on the floor in front of Patient #2’s chair. LPN 1 placed a paper barrier on the floor in front of the patient’s chair, next to three half‑full plastic milk jugs containing a yellow liquid. She placed her tablet and a packet of Sani‑wipes on the paper barrier. One milk jug made direct contact with the barrier. LPN 1 applied a dressing to the patient’s wound, wrapped the area with gauze, and applied pantyhose to secure it. She removed one glove to retrieve a roll of tape from her supply bag and then applied tape to the foam dressing. LPN 1 did not maintain a clean area for reusable supplies and did not remove gloves and perform hand hygiene before donning clean gloves and handling clean items. During an interview on 05/12/2026 at 1:40 PM, LPN 1 stated the milk jugs contained “pee.” She confirmed she placed her tablet and Sani‑wipes on the paper barrier and stated the barrier was considered a dirty area. During an interview on 05/13/2026 at 8:38 AM, the Alternate Administrator stated staff should place the barrier and equipment on a hard surface, ideally a table or chair, and not on the floor. 3. During an observation on 05/13/2026 at 9:30 AM, LPN 3 removed a soiled bandage from Patient #8’s right great toe while wearing gloves. She retrieved a bottle of wound cleaner from the clean supply box while still wearing the same contaminated gloves. LPN 3 did not remove gloves and perform hand hygiene after removing the soiled dressing and before accessing clean supplies. During an interview on 05/13/2026 at 10:05 AM, LPN 3 stated the wound cleaner in the box was located in a clean area. She stated she cleaned the bottle with a disinfectant wipe after use and acknowledged she should remove gloves before accessing the clean supply box. During an interview on 05/13/2026 at 10:20 AM, the Alternate Clinical Supervisor stated the nurse should not access the clean supply box while wearing dirty gloves. 410 IAC 17-12-1(m) 1. During an observation on 05/12/2026 at 12:05 PM, RN 3 removed stethoscope from around neck, listened to Patient #3's lungs then placed stethoscope back around her neck. RN 3 failed to clean stethoscope before and after use on Patient #3. RN 3 scrunched up dirty drape in left hand, holding it with her last 3 fingers, while using her thumb and first finger to do a head to toe assessment on Patient #3. RN failed to dispose of dirty supplies, glove change and hand hygiene after touching dirty drape and before touching patient. RN 3 gloved, then touched Patient #3's G-tube insertion site. RN 3 failed to hand hygiene before gloving. During an interview on 05/12/2026 at 1:00 PM, RN 3 indicates hand hygiene is to be completed before and after glove change, she indicated she knew she missed some infections control during the home visit. 2. During an observation on 05/12/2026 at 1:30 PM, the surveyor observed an ant on the floor in front of Patient #2’s chair. LPN 1 placed a paper barrier on the floor in front of the patient’s chair, next to three half‑full plastic milk jugs containing a yellow liquid. She placed her tablet and a packet of Sani‑wipes on the paper barrier. One milk jug made direct contact with the barrier. LPN 1 applied a dressing to the patient’s wound, wrapped the area with gauze, and applied pantyhose to secure it. She removed one glove to retrieve a roll of tape from her supply bag and then applied tape to the foam dressing. LPN 1 did not maintain a clean area for reusable supplies and did not remove gloves and perform hand hygiene before donning clean gloves and handling clean items. During an interview on 05/12/2026 at 1:40 PM, LPN 1 stated the milk jugs contained “pee.” She confirmed she placed her tablet and Sani‑wipes on the paper barrier and stated the barrier was considered a dirty area. During an interview on 05/13/2026 at 8:38 AM, the Alternate Administrator stated staff should place the barrier and equipment on a hard surface, ideally a table or chair, and not on the floor. 3. During an observations on 05/12/2025 at 2:57 PM, with Clinical Supervisor present, LPN 1 cleaned skin on Patient #5's right AC touched skin with gloves finger then pierced skin with a butterfly needle. LPN 1 rolled used needle up in glove, LPN 1 second attempt for labs, LPN 1 held lab tube in mouth while attempting to collect lab in right forearm, removed tube from mouth, attached to a vacutainer. Then LPN 1 provided Patient #5 family member with a syringe and needle to attempt to collect labs from right AC; family member palpated site, punctured skin using needle/syringe provided by LPN 1. LPN 1's third attempt for labs, LPN 1 healed lab tube in mouth while attempting to collect lab in right hand. LPN 1 touched skin then pierced skin with butterfly. LPN 1 removed lab tube from mouth, laying on patient chair. LPN 1 then removed right glove, entered nursing bag collected needle from nursing bag, used bare hand to remove butterfly needle from syringe and connected new needle to syringe. LPN 1 rolled butterfly needle, syringe and capped needle used during third attempt into used left glove. LPN 1 told patient/family member she has sharps container in car. LPN 1 then returned clean equipment in nursing bag without hand hygiene before touching clean equipment. LPN 1 and family member failed to hand hygiene before and after gloving, clean access site after touching and before piercing skin with needle; LPN 1 failed to properly discard biohazard material, failed to keep clean lab equipment from contacting LPN 1's body fluids, failed to hand hygiene before entering nursing bag, and failed to don gloves before touching blood contaminated lab equipment. During an interview on 05/12/2026 at 4:15 PM, the Clinical Supervisor indicated lab tubes are not to be placed in clinicians mouth, family members are not allowed to draw labs for agency, there was hand hygiene and infection control concerns that she noted during visit. 4. During an observation on 05/13/2026 at 9:30 AM, LPN 3 removed a soiled bandage from Patient #8’s right great toe while wearing gloves. She retrieved a bottle of wound cleaner from the clean supply box while still wearing the same contaminated gloves. LPN 3 did not remove gloves and perform hand hygiene after removing the soiled dressing and before accessing clean supplies. During an interview on 05/13/2026 at 10:05 AM, LPN 3 stated the wound cleaner in the box was located in a clean area. She stated she cleaned the bottle with a disinfectant wipe after use and acknowledged she should remove gloves before accessing the clean supply box. During an interview on 05/13/2026 at 10:20 AM, the Alternate Clinical Supervisor stated the nurse should not access the clean supply box while wearing dirty gloves.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure staff completed a nursing assessment for 5 of 7 home visit observations with a nurse. (Patients #2, #5, #8, #11) Findings include: 2. During an observation on 05/12/2026 at 1:30 PM, LPN 1 did not complete a head‑to‑toe assessment, including a skin assessment, for Patient #2. During an interview on 05/12/2026 at 2:00 PM, LPN 1 stated she completed the patient’s head‑to‑toe assessment, although she did not assess the patient’s back, buttocks, left lower leg, heels, or the areas between the toes. 3. During an observation on 05/13/2026 at 9:30 AM, LPN 3 failed to complete a head to toe assessment on Patient #8. During an interview on 05/13/2026 at 10:00 AM, LPN 3 stated she completed a head to toe assessment although she did not assess the patients back, buttock, posterior legs, heels, and in-between all toes. 4. During an observation on 05/14/2026 at 12:00 PM, LPN 2 failed to assess Patient #11's back, buttocks, feet, and toes, buttock, and back. During an interview on 05/13/2026 at 12:30 PM, LPN 2 stated the patient's caregiver completed wound care prior to her visit. LPN 2 stated she sees the patient weekly for wound care and measurements but stated she would mark the measurement as missed for that visit. During an interview on 05/13/2026 at 8:38 AM, the Alternate Administrator stated nurses are expected to do a full head to toe assessment on the patient at each visit. The expectation to assess back, between patients toes, heels, buttock, and back. During an interview on 05/132026 at 9:00 AM, the Clinical Supervisor stated nurses are to do a full assess head to toe assessment on all patient visits. 410 IAC 17-12-2(g) 2. During an observations on 05/12/2026 at 2:57 PM with Clinical Supervisor present, prior to entering visit LPN 1 indicated this was the first home visit after start of care. LPN 1 failed to assess Patient # 5's a skin, lungs, or abdomen during visit. Patient #5 remained in recliner for the entire home visit. At end of visit, Patient #5 asked for Clinical Supervisor and Surveyor to step out while LPN looked at PureWick (a non-invasive urine management device designed for adults experiencing urinary incontinence). LPN indicated she was done with visit after that, due to time restraint to get labs delivered. LPN failed to preform wound care. A review on Patient #5's record evidence a POC with a cert period of 05/07/2026 to 07/05/2026, a start of care date of 05/07/2026 indicates Skilled nurse to assess and evaluate co-morbid conditions including HTN, DM, LT arm DVT, COPD and conditions that present themselves during the course of episode. The POC indicates the skilled nurse to perform pressure ulcer care to Lt buttock area as follows: clean with saline apply hydrogel, cover with bordered gauze, to be changed daily. The POC also indicates no wound assessment was conducted on 05/07/2026 and skilled nursing visits are weekly. During an interview on 05/12/2026 at 4:15 PM, the Clinical Supervisor indicated the visit was completed and LPN would not be providing any other care to patient other than looking at PureWick placement. The Clinical Supervisor indicated she took notes during the visit and had concerns related to infection control, no mention of wound care not being provided or a head to toe completed.

This visit was for a Federal/State complaint survey of a Home Health Provider. Survey Dates: 03/02/2026 & 03/03/2026 Complaint: 2748499 with findings. Complaint: 2746445 with findings. 12 Month Unduplicated Skilled Admissions: 1226 Abbreviations: HHA - Home Health Aide LPN - Licensed Practical Nurse RN- Registered Nurse SN - Skilled Nurse POC- Plan of Care SOC- Start of Care QR on 03/11/2026 by A4

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure that the patient and their representative were provided with contact information for other community resources and with the names of alternative agencies or providers available to assume care, for 1 of 1 discharge‑for‑cause records reviewed (Patient #1). Findings include: A policy titled "Discharge Criteria and Process" dated 01/2025 required the agency to document its decision to terminate or reduce services, including the circumstances and notification to the patient and responsible family member. The agency must document efforts to resolve problems before discharge. If continued care is needed, the patient must receive contact information for other home health agencies and providers. The Clinical Manager or a designee is responsible for these actions. An undated document titled "Patient Rights and Responsibilities" states that the agency should comply with all applicable local, state, and federal laws or regulations and accepted professional standards or principles of practice. A review of Patient #1's record for the certification period 01/08/2026 to 03/08/2026 included a physician order dated 02/17/2026 to discharge the patient due to safety concerns. During an interview on 03/02/2026 at 2:08 PM, Patient #1's family stated that the agency terminated services effective immediately without providing 15 days' written notice. They said the agency discharged the patient due to staff safety concerns, but did not provide details about the specific issues. They stated the agency failed to facilitate a safe transfer to another provider. Despite the patient’s high-acuity needs—including a colostomy (opening in the abdominal wall), a Foley catheter (tube inserted to drain urine), and cardiac/pulmonary comorbidities (medical conditions)—the agency "simply stopped services," and they received no discharge paperwork by mail. The family expressed concern that this lack of coordination and failure to ensure continuity of care placed Patient #1 at immediate risk for hospitalization. During an interview on 03/03/2026 at 10:04 AM, the Clinical Supervisor stated staff reported feeling unsafe due to the brother’s intimidating behavior, such as standing in doorways and closing doors behind clinicians. During the final visit, several unidentified men were present in the home, prompting the clinical manager to cancel further staff visits due to safety concerns. She said the agency implemented "dual visits" for a month to keep staff safe. The Home Health Aide (HHA) performed only limited hygiene care because the patient refused full baths. The agency then stopped HHA services and wound care when the home became too dangerous for staff. She said she spoke with the Power of Attorney (POA) about the transition of care. The agency did not issue a 15-day discharge notice. It considered the situation an "immediate" safety risk. The medical social worker (MSW) did not participate in this episode. She coordinated follow-up appointments with the patient’s doctors and the wound center. She stated that the agency did not send the POA any mail notification with contact information and resources for other home health agencies and providers. During an interview on 03/03/2026 at 10:04 AM, the Alternate Administrator reviewed the case and questioned whether the Clinical Supervisor should have provided a list of alternative home health agencies and community resources. She noted that the patient was near the end of their care episode, remained mentally competent to make their own decisions, and had not verbalized any personal concerns regarding their safety. The agency failed to provide written contact information and resources as required by 484.50(d).

This visit was for a Federal/State complaint survey of a home health provider. Complaint #: 99776 with related and unrelated deficiencies cited. Survey Date: 07/13/2023-07/14/2023, 07/17/2023-07/20/2023, 07/26/2023 Unduplicated Skilled Admissions for the last 12 Months: 1980 A fully extended survey was announced on 7/14/2023. An Immediate Jeopardy related to §484.75 Skilled Professional Services was announced and identified on 07/14/2023 at 11:40 AM. The agency’s 2nd immediate jeopardy removal of immediacy plan and actions were determined to have removed the immediacy component of the immediate jeopardy on 7/19/2023 at 12:55 PM. The Immediate Jeopardy was abated at the time of exit on 07/20/2023. The exit date was extended to 7/26/2023 due to the receipt of requested documents. During this Federal Complaint Survey, Visiting Nurses Association of the Wabash Valley was found to be out of compliance with Conditions of Participation 42 CFR §484.50 Patient Rights, 42 CFR §484.60 Care Planning, Coordination, Quality of Care, and 42 CFR §484.75 Skilled Professional Services. Based on the Condition-level deficiencies identified during the 07/26/2023 survey, your home health agency was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act, on 07/14/2023. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training and/or competency evaluation programs for two years beginning 07/26/2023 and continuing through 07/25/2025. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. QR Completed on 07/28/2023 by A4.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on record review, observation, and interview, the agency failed to investigate medication complaint errors in 5 of 5 medication error complaints completed (see tag G480) that resulted in the death of a patient. Failed to follow through per agency policy to investigate, analyze, and document the complaint (see tag G484). Failure to follow agency policy resulted in the death of one patient (Patient #1) on 07/07/2023 related to IV (intravenous) medication administration. The failure of the quality team to investigate, analyze, and immediately address the 07/07/2023 incident has the potential to cause further serious harm, hospitalization, and death to all current patients and any new patient admissions. The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the Condition of Participation 42 CFR 484.50 Patient Rights. Findings Include: 1. An undated policy titled, "Patient Rights and Responsibilities" was provided by the Regulatory Director on 07/20/2023 at 9:00 AM. The policy indicated but was not limited to, "To expect compliance of the agency with all applicable local, state, and federal laws and regulations and accepted professional standards or principles of practice." 2. An undated policy titled, "Complaint/Grievance Process" was provided by the Regulatory Director on 07/13/2023 at 4:10 PM. The policy indicated but was not limited to, "The organization will investigate complaints regarding treatment or care, mistreatment, neglect" ... "including injuries of unknown source" ... "The organization shall be responsible for asking the necessary questions to determine causes of injuries." ... "1. The organization staff member receiving the complaint will discuss, verbally and in writing, the grievance with a supervisor within five (5) days of the alleged grievance. The supervisor will investigate the grievance within five (5) business days after receipt of such grievance and will make every effort to resolve the grievance to the patient's satisfaction." ... "4. Complaints and any action taken will be documented on an electronic complaint form." ... "5. Corrective action will be specific and related to the complaint." ... "6. Resolution information will be communicated verbally or in writing to the patient or his/her representative filing the complaint." ... "8. All complaints from patients who believe their privacy rights have been violated will be forwarded for review to the designated organization personnel or office specified in the organization's Notice of Privacy Process." 3. An undated policy titled, "Root Cause Analysis/Action Plan" was provided by the Regulatory Director on 07/14/2023 at 1:30 PM. The policy indicated but was not limited to, "1. When a serious adverse event is discovered, a root cause analysis will be conducted to identify the basic or causal factors that underlie variation in performance.2. The root cause analysis will focus primarily on systems and processes, not individual performance. 3. The analysis will progress from special causes in clinical/service processes, unusual circumstances or events that are difficult to anticipate, to common causes in organization processes. It will identify potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or determines, after analysis, that no such improvement opportunities exist. 4. Ordinarily, common cause variation can only be improved by redesigning a process. The intention will be not to accept an event as either human error or equipment breakdown, but to delve into what preceded the event or allowed it to occur." ... "Action Plan 1. An action plan will be initiated after the root cause analysis is completed. 2. The action plan will be the product of the root cause analysis, which identifies the strategies the organization intends to implement to reduce the risk of similar events occurring in the future. 3. The plan will address responsibility for implementation, oversight, pilot testing as appropriate, timelines, and strategies for measuring the effectiveness of the action." 4. An undated policy titled, "Serious Adverse Events" was provided by the Regulatory Director on 7/20/2023 at 10:25 AM. The policy indicated but was not limited to, "Stage 1: Immediately after the event, or hearing about the event (the first 48 hours) 1. Inform the Chief Executive Officer of the designee so he/she can provide information to any appropriate outside parties. 2. Make sure the organization is doing everything possible to provide follow-up care/services to ensure the best possible outcomes for injured parties/property and/or personnel. 3. Ensure that all parties involved in the event receive appropriate information to avoid miscommunication. Establish a mechanism for updates, as needed, using a designated spokesperson for consistency." ... "4. Follow any immediate regulator reporting requirement" ... " 5. Document appropriate information in occurrence reports and other risk management forms and submit to the Chief Executive Officer or designees and the Regulatory Director. Document objective clinical findings in the clinical record as necessary. 6.Document all confidential attorney patient communications and address to the corporate attorney. 7. Gather detailed information about the event." 5. A document titled, "Medication Error Report" dated 07/07/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The summarized document indicates a medication error involving Patient 1, Invanz (an antibiotic used to treat infections) 1 Gram IV (intravenous) every 24 hours was ordered, however, RN 2 administered Epinephrine (used to treat severe allergic reactions) 1 milligram was administered" ... "Client Adverse Outcome: EMS" Client Adverse Outcome does not indicate patient death. No staff education was documented. 6. A document titled, "Medication Error Report" dated 06/22/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated but was not limited to, "Narrative Description of Medication Error: Patient has been taking Hydrochlorothiazide 12.5 mg tablet, 2 tabs in the morning. He should be taking it 3 times daily. Patient taking Potassium 20 MEQ, one tablet twice daily and it should be 2 tabs twice daily." No patient or staff education was documented. 7. A document titled, "Medication Error Report" dated 06/18/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated, but was not limited to, "Narrative Description of Medication Error: Patient taking Metoprolol 23 ER BID (extended release twice a day), VNA records reflect once a day". No follow-up comments were documented & no patient and/or staff education was provided. 8. A document titled, "Medication Error Report" dated 04/14/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated, but was not limited to, "Narrative Description of Medication Error: Increased Carvedilol (used to treat high blood pressure) dose from 4/13/23 not put in med box during SNV (skilled nursing visit) 4/14/23". No follow-up was documented. No staff education was documented. 9. A document titled, "Medication Error Report" dated 02/28/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated but was not limited to, "Narrative Description of Medication Error: Patient has 2 different RX (prescriptions) for Digoxin (medication used to treat heart failure & rhythm problems). One for 125 the other for 250. Clarified with the Physician that the patient takes 250. Informed nurse for the doctor that patient took the 125 for one week". No patient or staff education was documented. No follow-up was documented. 10. During an interview on 07/13/2023 at 1:52 PM the Regulatory Director and Clinical Educator stated the agency had not conducted any re-education on Intravenous (IV) medication since the 07/07/2023 IV medication error that resulted in Patient #1’s death. The Regulatory Director stated he/she jotted notes down in a notebook but had no formal report because the agency was still analyzing the 07/07/2023 event. The Regulatory Director was asked to provide a copy of the notes from the notebook he/she was carrying around during the survey. The Regulatory Director stated he/she still needed to fill out the form and would not provide a copy of the notebook notes. 11. During a home visit on 07/14/2023 at 11:00 AM Registered Nurse (RN) 5 stated the agency sends out messages on the Forcura system, emails, and phone calls prompting staff on re-education. RN 5 stated he/she was on vacation last week and had not received any notification regarding re-education prior to the 07/14/2023 home visit with Patient #9 for IV medication infusion. 12. During an interview on 07/18/2023 at 4:15 PM the Administrator, Regulatory Director, and Clinical Supervisor stated the agency had not received any training from Entity 1 pharmacy regarding administration of Epinephrine. The agency had not provided additional education to the staff since the 07/07/2023 incident.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the admission packets included the most current transfer and discharge policy for a 15-day notice of discharge for 5 of 5 patients. (Patients #2, #3, #9, #5, and #12) Findings Include: 1. An undated policy titled Discharge Criteria and Process was provided by the Regulatory Nurse on 07/20/2023 at 9:00 AM. The policy indicated, “…Procedure 1. The organization will verbally notify the patient of the decision to terminate services 15 days before the time services are to end…” 2. During a home visit for Patient #3 on 07/13/2023 at 12:20 PM the agency admission packet was reviewed. The packet included an undated discharge policy. The discharge policy failed to indicate the patient would receive a 15-day notice before being discharged from agency services. 3. During a home visit for Patient #9 on 07/14/2023 at 9:30 AM, the agency admission packet was reviewed. The packet included an undated discharge policy. The discharge policy failed to indicate the patient would receive a 15-day notice before being discharged from agency services. 4. During a home for Patient #5 on 07/17/2023 at 9:55 AM the agency admission packet was reviewed. The packet included an undated discharge policy. The discharge policy failed to indicate the patient would receive a 15-day notice before being discharged from agency services. 5. During a home visit for Patient #12 on 07/17/2023 at 1:30 PM the agency admission packet was reviewed. The packet included an undated discharge policy. The discharge policy failed to indicate the patient would receive a 15-day notice before being discharged from agency services. 6. During a home visit for Patient #2 on 07/18/2023 at 9:40 AM the agency admission packet was reviewed. The packet included an undated discharge policy. The discharge policy failed to indicate the patient would receive a 15-day notice before being discharged from agency services. 7. During an interview on 07/13/2023 at 12:20 PM the Regulatory Nurse indicated the policy had been updated, but confirmed the new policy had not been provided to all patients.

Treatment or care CFR(s): 484.50(e)(1)(i)(A) (i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to investigate care furnished in 5 of 5 medication error complaints reviewed between 02/14/2023-7/12/2023. Findings Include: 1. An undated policy titled, "Patient Rights and Responsibilities" was provided by the Regulatory Director on 07/20/2023 at 9:00 AM. The policy indicated but was not limited to, "To expect compliance of the agency with all applicable local, state, and federal laws and regulations and accepted professional standards or principles of practice." 2. An undated policy titled, "Complaint/Grievance Process" was provided by the Regulatory Director on 07/13/2023 at 4:10 PM. The policy indicated but was not limited to, "The organization will investigate complaints regarding treatment or care, mistreatment, neglect" ... "including injuries of unknown source" ... "The organization shall be responsible for asking the necessary questions to determine causes of injuries." ... "1. The organization staff member receiving the complaint will discuss, verbally and in writing, the grievance with a supervisor within five (5) days of the alleged grievance. The supervisor will investigate the grievance within five (5) business days after receipt of such grievance and will make every effort to resolve the grievance to the patient's satisfaction." ... "4. Complaints and any action taken will be documented on an electronic complaint form." ... "5. Corrective action will be specific and related to the complaint." ... "6. Resolution information will be communicated verbally or in writing to the patient or his/her representative filing the complaint." ... "8. All complaints from patients who believe their privacy rights have been violated will be forwarded for review to the designated organization personnel or office specified in the organization's Notice of Privacy Process." 3. An undated policy titled, "Root Cause Analysis/Action Plan" was provided by the Regulatory Director on 07/14/2023 at 1:30 PM. The policy indicated but was not limited to, "1. When a serious adverse event is discovered, a root cause analysis will be conducted to identify the basic or causal factors that underlie variation in performance.2. The root cause analysis will focus primarily on systems and processes, not individual performance. 3. The analysis will progress from special causes in clinical/service processes, unusual circumstances or events that are difficult to anticipate, to common causes in organization processes. It will identify potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or determines, after analysis, that no such improvement opportunities exist. 4. Ordinarily, common cause variation can only be improved by redesigning a process. The intention will be not to accept an event as either human error or equipment breakdown, but to delve into what preceded the event or allowed it to occur." ... "Action Plan 1. An action plan will be initiated after the root cause analysis is completed. 2. The action plan will be the product of the root cause analysis, which identifies the strategies the organization intends to implement to reduce the risk of similar events occurring in the future. 3. The plan will address responsibility for implementation, oversight, pilot testing as appropriate, timelines, and strategies for measuring the effectiveness of the action." 4. An undated policy titled, "Serious Adverse Events" was provided by the Regulatory Director on 7/20/2023 at 10:25 AM. The policy indicated but was not limited to, "Stage 1: Immediately after the event, or hearing about the event (the first 48 hours) 1. Inform the Chief Executive Officer of the designee so he/she can provide information to any appropriate outside parties. 2. Make sure the organization is doing everything possible to provide follow-up care/services to ensure the best possible outcomes for injured parties/property and/or personnel. 3. Ensure that all parties involved in the event receive appropriate information to avoid miscommunication. Establish a mechanism for updates, as needed, using a designated spokesperson for consistency." ... "4. Follow any immediate regulator reporting requirement" ... " 5. Document appropriate information in occurrence reports and other risk management forms and submit to the Chief Executive Officer, designees, and the Regulatory Director. Document objective clinical findings in the clinical record as necessary. 6. Document all confidential attorney patient communications and address to the corporate attorney. 7. Gather detailed information about the event." 5. A document titled, "Medication Error Report" dated 07/07/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The summarized document indicates a medication error involving Patient 1, Invanz (an antibiotic used to treat infections) 1 Gram IV (intravenous) every 24 hours was ordered, however, RN 2 administered Epinephrine (used to treat severe allergic reactions) 1 milligram was administered" ... "Client Adverse Outcome: EMS" Client Adverse Outcome does not indicate patient death. No staff education was documented. 6. A document titled, "Medication Error Report" dated 06/22/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated but was not limited to, "Narrative Description of Medication Error: Patient has been taking Hydrochlorothiazide 12.5 mg tablet, 2 tabs in the morning. He should be taking 3 times daily. Patient taking Potassium 20 MEQ, one tablet twice daily and it should be 2 tabs twice daily." No patient or staff education was documented. 7. A document titled, "Medication Error Report" dated 06/18/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated, but was not limited to, "Narrative Description of Medication Error: Patient taking Metoprolol 23 ER BID (extended release twice a day), VNA records reflect once a day". No follow-up comments were documented & no patient and/or staff education was provided. 8. A document titled, "Medication Error Report" dated 04/14/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated, but was not limited to, "Narrative Description of Medication Error: Increased Carvedilol (used to treat high blood pressure) dose from 4/13/23 not put in the med box during SNV (skilled nursing visit) 4/14/23". No follow-up was documented. No staff education was documented. 9. A document titled, "Medication Error Report" dated 02/28/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated but was not limited to, "Narrative Description of Medication Error: Patient has 2 different RX (prescriptions) for Digoxin (medication used to treat heart failure & rhythm problems). One for 125 the other for 250. Clarified with the Physician that the patient takes 250. Informed nurse for the doctor that patient took the 125 for one week". No patient or staff education was documented. No follow-up was documented. 10. During an interview on 07/13/2023 at 1:52 PM the Regulatory Director and Clinical Educator stated the agency had not conducted any re-education on Intravenous (IV) medication since the 07/07/2023 IV medication error that resulted in Patient #1’s death. The Regulatory Director stated he/she jotted notes down in a notebook but had no formal report because the agency was still analyzing the 07/07/2023 event. The Regulatory Director was asked to provide a copy of the notes from the notebook he/she was carrying around during the survey. The Regulatory Director stated he/she still needed to fill out the form and would not provide a copy of the notebook notes. 11. During a home visit on 07/14/2023 at 11:00 AM Registered Nurse (RN) 5 stated the agency sends out messages on the Forcura system, emails, and phone calls prompting staff on re-education. RN 5 stated he/she was on vacation last week and had not received any notification regarding re-education prior to the 07/14/2023 home visit with Patient #9 for IV medication infusion. 12. During an interview on 07/18/2023 at 4:15 PM the Administrator, Regulatory Director, and Clinical Supervisor stated the agency had not received any training from Entity 1 pharmacy regarding administration of Epinephrine. The agency had not provided any additional education to the staff since the 07/07/2023 incident. 410 IAC 17-12-3(c)(1)(A)(2)

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to investigate and document 5 of 5 complaints reviewed involving medication errors. Findings Include: 1. An undated policy titled, "Patient Rights and Responsibilities" was provided by the Regulatory Director on 07/20/2023 at 9:00 AM. The policy indicated but was not limited to, "To expect compliance of the agency with all applicable local, state, and federal laws and regulations and accepted professional standards or principles of practice." 2. An undated policy titled, "Complaint/Grievance Process" was provided by the Regulatory Director on 07/13/2023 at 4:10 PM. The policy indicated but was not limited to, "The organization will investigate complaints regarding treatment or care, mistreatment, neglect" ... "including injuries of unknown source" ... "The organization shall be responsible for asking the necessary questions to determine causes of injuries." ... "1. The organization staff member receiving the complaint will discuss, verbally and in writing, the grievance with a supervisor within five (5) days of the alleged grievance. The supervisor will investigate the grievance within five (5) business days after receipt of such grievance and will make every effort to resolve the grievance to the patient's satisfaction." ... "4. Complaints and any action taken will be documented on an electronic complaint form." ... "5. Corrective action will be specific and related to the complaint." ... "6. Resolution information will be communicated verbally or in writing to the patient or his/her representative filing the complaint." ... "8. All complaints from patients who believe their privacy rights have been violated will be forwarded for review to the designated organization personnel or office specified in the organization's Notice of Privacy Process." 3. An undated policy titled, "Root Cause Analysis/Action Plan" was provided by the Regulatory Director on 07/14/2023 at 1:30 PM. The policy indicated but was not limited to, "1. When a serious adverse event is discovered, a root cause analysis will be conducted to identify the basic or causal factors that underlie variation in performance.2. The root cause analysis will focus primarily on systems and processes, not individual performance. 3. The analysis will progress from special causes in clinical/service processes, unusual circumstances or events that are difficult to anticipate, to common causes in organization processes. It will identify potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or determines, after analysis, that no such improvement opportunities exist. 4. Ordinarily, common cause variation can only be improved by redesigning a process. The intention will be not to accept an event as either human error or equipment breakdown, but to delve into what preceded the event or allowed it to occur." ... "Action Plan 1. An action plan will be initiated after the root cause analysis is completed. 2. The action plan will be the product of the root cause analysis, which identifies the strategies the organization intends to implement to reduce the risk of similar events occurring in the future. 3. The plan will address responsibility for implementation, oversight, pilot testing as appropriate, timelines, and strategies for measuring the effectiveness of the action." 4. An undated policy titled, "Serious Adverse Events" was provided by the Regulatory Director on 7/20/2023 at 10:25 AM. The policy indicated but was not limited to, "Stage 1: Immediately after the event, or hearing about the event (the first 48 hours) 1. Inform the Chief Executive Officer of the designee so he/she can provide information to any appropriate outside parties. 2. Make sure the organization is doing everything possible to provide follow-up care/services to ensure the best possible outcomes for injured parties/property and/or personnel. 3. Ensure that all parties involved in the event receive appropriate information to avoid miscommunication. Establish a mechanism for updates, as needed, using a designated spokesperson for consistency." ... "4. Follow any immediate regulator reporting requirement" ... " 5. Document appropriate information in occurrence reports and other risk management forms and submit to the Chief Executive Officer, designees, and the Regulatory Director. Document objective clinical findings in the clinical record as necessary. 6. Document all confidential attorney patient communications and address to the corporate attorney. 7. Gather detailed information about the event." 5. A document titled, "Medication Error Report" dated 07/07/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The summarized document indicates a medication error involving Patient 1, Invanz (an antibiotic used to treat infections) 1 Gram IV (intravenous) every 24 hours was ordered, however, RN 2 administered Epinephrine (used to treat severe allergic reactions) 1 milligram was administered" ... "Client Adverse Outcome: EMS" Client Adverse Outcome does not indicate patient death. No staff education was documented. 6. A document titled, "Medication Error Report" dated 06/22/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated but was not limited to, "Narrative Description of Medication Error: Patient has been taking Hydrochlorothiazide 12.5 mg tablet, 2 tabs in the morning. He should be taking it 3 times daily. Patient taking Potassium 20 MEQ, one tablet twice daily and it should be 2 tabs twice daily." No patient or staff education was documented. 7. A document titled, "Medication Error Report" dated 06/18/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated, but was not limited to, "Narrative Description of Medication Error: Patient taking Metoprolol 23 ER BID (extended release twice a day), VNA records reflect once a day". No follow-up comments were documented & no patient and/or staff education was provided. 8. A document titled, "Medication Error Report" dated 04/14/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated, but was not limited to, "Narrative Description of Medication Error: Increased Carvedilol (used to treat high blood pressure) dose from 4/13/23 not put in the med box during SNV (skilled nursing visit) 4/14/23". No follow-up was documented. No staff education was documented. 9. A document titled, "Medication Error Report" dated 02/28/2023 was provided by the Regulatory Director on 07/13/2023 at 10:00 AM. The document indicated but was not limited to, "Narrative Description of Medication Error: Patient has 2 different RX (prescriptions) for Digoxin (medication used to treat heart failure & rhythm problems). One for 125 the other for 250. Clarified with the Physician that the patient takes 250. Informed nurse for the doctor that patient took the 125 for one week". No patient or staff education was documented. No follow-up was documented. 10. During an interview on 07/13/2023 at 1:52 PM the Regulatory Director stated he/she jotted notes down in a notebook but had no formal report because the agency was still analyzing the 07/07/2023 event, the death of a patient (Patient #1). The Regulatory Director was asked to provide a copy of the notes from the notebook he/she was carrying around during the survey. The Regulatory Director stated he/she still needed to fill out the form and would not provide a copy of the notebook notes.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure nursing staff reviewed all current medications and failed to ensure medication reconciliations were performed for 5 of 5 home visit observations. (Patients #3, #9, #5, #12, #2) 1. An undated policy titled Medication Profile was provided by the Regulatory Nurse on 07/20/2023 at 10:25 AM. The policy indicated, “…Medications will be updated for each change to reflect current medications, new, and/or discontinued medications…2. A drug regimen review will be performed at the time of admission when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy…4. Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the specific medication…” 2. The manufacturer’s instructions for Prolastin-C (a medication used to treat emphysema) indicated, “…Warnings and Precautions 5.1…Hypersensitivity reactions, including anaphylaxis, may occur…Have epinephrine and other appropriate therapy available for the treatment of any acute anaphylactic…reaction…” 3. During a home visit with Patient #3 on 07/13/2023 at 12:20 PM (Registered Nurse) RN 1 administered Prolastatin (a medication to treat emphysema) IV (intravenous) and failed to review all current medications or reconcile the patient’s medication regime. During an interview on 7/13/2023, Patient #3 indicated the agency did not provide them with a comprehensive medication list. 4. During a home visit for Patient #9 on 07/14/2023 at 9:30 AM, RN 5 failed to review all current medications or reconcile the patient’s medication regime. Patient #9's clinical record was reviewed on 07/17/2023. The following discrepancies were identified between the patient-created compilation and the current physician orders of Patient #9. The physician orders included, but were not limited to, the following orders: Copper Gluconate (a supplement) 2 mg capsule twice daily, NAC (N-Acetyl Cysteine) (a supplement) 600 mg twice daily, Para-aminobenzoic acid (a supplement) 500 mg daily, Pyridoxine (Vitamin B-6) (a supplement) 250 mg daily, Triple Magnesium Complex 400 mg magnesium capsule (a supplement) daily, VB6 P5P (Vitamin B 6) (a supplement) 100 mg/gram oral powder 250 mg twice daily, Prolastin-C 1000 mg (+/-)/20 ml intravenous solution 3760 mg IV weekly, Heparin (a medication to prevent clotting) lock flush 100 unit/ml intravenous 5 ml weekly, and Normal saline flush 0.9% injection syringe 10 ml as directed before and after Prolastin infusion weekly The patient-created compilation included, but was not limited to, the following orders: Copper 2 mg twice daily, NAC 600 mg twice daily, Para-aminobenzoic acid 500 mg daily (February-October) for sun poisoning, Vitamin B-6 250 mg daily, Triple magnesium complex 420 mg daily, P5P (Vitamin B-6) 250 mg daily, and Prolastin 10 mg weekly infusion. During an interview on 7/14/2023, Patient #9 indicated the agency did not provide them a comprehensive medication list and provided a self-compiled medication list. 5. During a home visit with Patient #5 on 07/17/2023 at 9:55 AM RN 3 failed to review all current medications or reconcile the resident’s medication regime. Patient 5 indicated the agency did not provide a comprehensive medication list and was observed to have HCTZ (Hydrochlorothiazide) (a diuretic medication) on hand. Patient #5 indicated she had only been taking Toprol (a cardiac medication) once daily and had not taken the HCTZ since returning home from the hospital in June of 2023, but was taking Tylenol Extra Strength two tabs twice daily. A review of Patient #5's clinical record evidenced a physician order that included, but was not limited to, an order for Metoprolol (Toprol) 25 mg tablet 3 tablets twice daily but did not include orders for Tylenol ES (a pain medication) or HCTZ (a diuretic). During an interview on 7/14/2023, RN 3 indicated they would update the physician and ask for clarification and the plan of care as soon as possible. 6. During a home visit with Patient #12 on 07/17/2023 at 1:30 PM, RN 5 failed to review all current medications or reconcile the patient’s medication regime. During an interview on 07/17/2023 at 1:32 PM Patient 12 indicated the agency did not provide a comprehensive medication list. 7. During a home visit with Patient #2 on 07/18/2023 at 9:40 AM, RN 1 failed to review all current medications or reconcile the patient’s medication regime. During an interview on 07/18/2023 at 9:42 AM, Patient 2 indicated the agency did not provide a comprehensive medication list, but a couple of months ago she had started taking an Iron supplement daily. During an interview on 07/18/2023 at 9:43 AM, RN 1 indicated she had not notified the physician of the supplement and had not added it to the plan of care, but would as soon as possible. 410 IAC 17-14-1(a)(1)(B)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure a complete and up-to-date list of current medications were listed on the plan of care in 14 of 18 record reviews completed. (Patient #1, 2, 3, 5, 6, 8, 9, 11, 12, 13, 14, 15, 16, 17) Findings Include: 1, An undated policy titled, "Care Planning Process" was provided by the Regulatory Director on 7/17/2023 at 4:10 PM. The policy indicated, but was not limited to, "Based on the assessment and conclusions, the plan of care will include, but will not be limited to:" ... "All Medications". 2. The package insert for Prolastin-C Liquid indicated but was not limited to, "Warnings and Precautions" ... "Hypersensitivity Reactions" ... "If hypersensitivity symptoms occur, promptly stop Prolastin-C Liquid and begin appropriate therapy. Have Epinephrine or other appropriate therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction". 3. The package insert for Daptomycin (Cubicin) indicated but was not limited to, "Warnings and Precautions" ... "Anaphylaxis/Hypersensitivity Reactions" ... "Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening. If an allergic reaction to CUBICIN occurs, discontinue the drug and institute appropriate therapy". 4. The POC (Plan of Care) for Patient #1, SOC (start of care) 6/25/2023, Certification period 6/25/2023-8/2/20233 reviewed on 7/13/2023 failed to include the following physician-ordered intravenous (IV) medications: Epinephrine (used to treat life-threatening allergic reactions) and Invanz (antibiotic to treat infections). 5. The POC for Patient #2, SOC 4/18/2023, Certification period 6/17/2023-8/15/2023 reviewed on 7/19/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency, such as anaphylaxis as indicated by the package insert with Prolastin therapy. 6. The POC for Patient #3, SOC 12/6/2022, Certification period 6/4/2023-8/2/2023 reviewed on 7/18/2023 failed to include the following physician-ordered medications: Epinephrine, over-the-counter Ibuprofen (used to treat fevers, pain, inflammation) and failed to include the correct dose of Prednisone (a medication used to decrease inflammation). A document for Patient #3 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". 7. The POC for Patient #5, SOC 6/21/2023, Certification period 6/21/2023-8/19/2023 reviewed on 7/17/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency, such as anaphylaxis, as indicated by the package insert with Daptomycin (Cubicin) therapy. 8. The POC for Patient #6, SOC 5/2/2014, Certification period 7/14/2023-9/11/2023 failed to include the physician-ordered anaphylaxis medication, Epinephrine. A document for Patient #6 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". 9. The POC for Patient #8, SOC 4/13/2020, Certification period 5/28/2023-7/27/2023 was provided by the Regulatory Director on 7/17/2023 and failed to include the physician-ordered medication, Epinephrine. 10. The POC for Patient #9, SOC 12/9/2022, Certification period 6/7/2023-8/5/2023 reviewed on 7/14/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency, such as anaphylaxis, as indicated by the package insert with Prolastin therapy. 11. The POC for Patient #11, SOC 6/14/2023, Certification period 6/14/2023-8/12/2023 failed to include the following physician-ordered medications: Epinephrine, Diphenhydramine capsule, and injection (used to treat allergic reactions), Sodium Chloride (medication used to dilute other medications for IV (intravenous administration), Lidocaine-Prilocaine topical (used topically as numbing agent), Zemaira IV (used to treat Alpha-1-Antitrypsin Deficiency), Heparin (used to prevent blood clots), and Oxygen. A document for Patient #11 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". A document for Patient #11 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". A document for Patient #11 titled, "Client Coordination Note Report" dated 7/12/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Hung Zemaira per gravity for infusion. Port then flushed with 10 ml (milliliters) NS (normal saline) followed by 5 ml Heparin." A document for Patient #11 titled, "Physician Order" dated 7/16/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The summarized document indicated but was not limited to, a physician order for Zemaira 8,520 mg (milligrams) intravenously weekly that was back-dated to 6/14/2023. A document for Patient #11 titled, "Physician Order" dated 7/5/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The summarized document indicated but was not limited to, a physician order for Diphenhydramine 25 mg capsule, Diphenhydramine 20 mg/ml injection, Epinephrine 0.3mg/0.3ml injection, Lidocaine-Prilocaine 2.5%-2.5% topical, Oxygen, Sodium Chloride 0.9% intravenous. 12. The POC for Patient # 12, SOC 12/5/2022, Certification period 6/3/2023-8/1/2023 reviewed on 7/19/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency, such as anaphylaxis as indicated by the package insert with Prolastin therapy. 13. The POC for Patient # 13, SOC 12/8/2022, Certification period 6/6/2023-8/4/2023 reviewed on 7/19/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency, such as anaphylaxis, as indicated by the package insert with Prolastin therapy. 14. A summarized document for Patient #14 titled, "Client Coordination Note Report" dated 7/14/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document charted by RN 7 indicated but was not limited to, calling the spouse of Patient 14 to verify pre-administration and anaphylactic medications in the home. Spouse verified patient continues with Tylenol and Benadryl 1 hour prior to infusion, no Epinephrine in the home. Pre-medication medications were added to the patient chart. 15. The POC for Patient #15, SOC 7/14/2020, Certification period 6/29/2023-8/27/2023 failed to include the physician-ordered anaphylaxis medication, Epinephrine. A document for Patient #15 charted by RN 13, titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include Anaphylaxis Orders." 16. The POC for Patient #16, SOC 2/6/2014, Certification period 6/19/2023-8/17/2023 failed to include the physician-ordered medication, Epinephrine. A document for Patient #16 charted by RN 5, titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include Anaphylaxis Orders." 17. The POC for Patient #17, SOC 4/19/2023, Certification period 6/18/2023-8/16/2023 failed to include the physician-ordered medication, Epinephrine. 18. During an observation on 07/13/2023 at 12:20 PM, the Registered Nurse was observed going over Patient 3's medications in the home. The Plan of Care failed to include over-the-counter Ibuprofen and Epinephrine, the correct dose of Prednisone, and Oxygen therapy, but did include Cetirizine, a medication Patient 3 was no longer taking. 19. During an interview on 7/13/2023, the Regulatory Director indicated that the Plan of Care is not updated with changes, including medication changes between certification periods. 20. During an interview on 7/13/2023 at 4:21 PM, the Regulatory Director indicated that all first-dose IV antibiotic infusions are sent an anaphylactic kit in the event of an emergency. Each pharmacy, specified by the patients' individual pharmacy, sends these kits to the patient's homes. Indicated that each kit is different and could not identify what specifically was in the emergency kits. 21. During an interview on 7/20/2023 at 9:41 AM, the Clinical Supervisor indicated Patient #14 pharmacy sends Benadryl only, not Epinephrine. Indicated that Patient #18 had Epinephrine in the home, vial, and syringe, but is refusing to have it removed at this time. The agency has a plan to remove all ampules where staff have to draw up Epinephrine and replace them with Epi-pens to avoid mistakes in the future. The patient agreed to speak with a physician to obtain an order to replace the current ampule of Epinephrine with a pre-drawn pen, however, is leaving the country soon with no definitive date when this can be done. If insurance will not cover pre-filled syringes, the patient agreed to cover the cost out of pocket to be in compliance. Indicated that Patient 17's Epinephrine in the home had expired, and was destroyed with the plan to replace it. 17-13-1 (a)(1)(C) (ix)(x)

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on observation, interviews, and record reviews, the facility failed to ensure plans of care were effectively reviewed and revised for 3 of 18 records reviewed (Patients #2, #5, and #12). 1. An undated policy titled Care Planning Process provided by the Regulatory Nurse on 07/17/2023 at 4:10 PM indicated, “…A written plan of care will be…updated…as patient’s condition warrants…” 2. During a home visit observation with Patient #5 on 07/17/2023 at 9:55 AM RN 3 failed to review all current medications or reconcile the patient’s medication regime. During an interview Patient 5 indicated the agency did not provide a comprehensive medication list and was observed to have HCTZ (Hydrochlorothiazide) (a diuretic medication) on hand. Patient #5 indicated she had only been taking Toprol (a cardiac medication) once daily and had not taken the HCTZ since returning home from the hospital in June of 2023, but was taking Tylenol Extra Strength two tabs twice daily. The physician orders included, but were not limited to, an order for Metoprolol (Toprol) 25 mg tablet 3 tablets twice daily, but did not include orders for Tylenol ES or HCTZ. RN 3 indicated she would update the physician for clarification and the plan of care as soon as possible. 3. During a home visit observation on 07/17/2023 at 1:30 PM Patient #12 indicated she had an allergy to adhesives. The clinical record did not indicate Patient #12 had an allergy to adhesives and RN 5 failed to ensure the primary care provider was notified or the clinical record was updated to include the allergy. 4. During a home visit observation with Patient #2 on 07/18/2023 at 9:40 AM RN 1 failed to review all current medications or reconcile the patient’s medication regime. During an interview Patient #2 indicated the agency did not provide a comprehensive medication list, but a couple of months ago she had started taking an Iron supplement daily. RN 1 indicated she had not updated the plan of care, but would as soon as possible. 5. The POC for Patient #3, SOC 12/6/2022, Certification period 6/4/2023-8/2/2023 reviewed on 7/18/2023 failed to include the following medications: Epinephrine, over-the-counter Ibuprofen (used to treat fevers, pain, inflammation) and failed to include the correct dose of Prednisone (a medication used to decrease inflammation). 410 IAC 484.60(c)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure standard infection control precautions were followed for 5 of 5 home visit observations. (Patients #2, #3, #5, #9, #12) 1. An undated policy titled Hand Hygiene was provided by the Regulatory Nurse on 07/18/2023 at 11:30 AM. The policy indicated, but was not limited to, “…3. Hand decontamination using an alcohol-based hand rub should be performed: B. Before donning sterile gloves when performing sterile procedures…peripheral vascular catheters, or other invasive devices…E. When moving from a contaminated body site to a clean body site during patient care. F. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. G. After removing gloves…” 2. The manufacturer’s instructions for Lysol cleansing wipes reviewed on 07/14/2023 at 10:00 AM indicated, “…To disinfect allow to remain visibly wet time for (four) 4 minutes…” 3. The manufacturer’s instructions for Sani wipes reviewed on 07/18/2023 at 2:32 PM indicated, “…Allow the surface to remain wet for two [2] minutes…” 4. During a home visit observation with Patient #3 on 07/13/2023 at 12:20 PM (Registered Nurse) RN 1 failed to change gloves or perform hand hygiene after touching the exterior of a storage cabinet drawer while preparing equipment for an IV infusion. 5. During a home visit observation with Patient #9 on 07/14/2023 at 9:30 AM RN 5 failed to apply gloves prior to preparing equipment for accessing a subclavian port, failed to perform hand hygiene after touching her hair and front of uniform with gloved hands, failed to perform hand hygiene before changing gloves to access the subclavian port, and failed to ensure equipment cleaned with Lysol cleansing wipes maintained a wet time of 4 (four) minutes for effective disinfection. 6. During a home visit observation with Patient #5 on 07/17/2023 at 9:55 AM, RN 3 failed to ensure equipment cleaned with Sani-wipes maintained a wet time of (two) 2 minutes for effective disinfection. 7. During a home visit observation with Patient #12 on 07/17/2023 at 1:30 PM, RN 5 failed to ensure equipment cleaned with Sani-wipes maintained a wet time of 2 minutes for effective disinfection. 8. During a home visit observation with Patient #2 on 07/18/2023 at 9:40 AM, RN 1 failed to ensure equipment cleaned with Sani-wipes maintained a wet time of 2 minutes for effective disinfection. 9. During an interview on 07/18/2023 at 2:30 PM the Regulatory Nurse indicated the nursing staff should perform hand hygiene before sterile procedures, between clean/dirty procedures, and between glove changes. The Regulatory Nurse indicated nursing staff should ensure equipment cleaned with Lysol wipes should remain wet for 4 minutes, and equipment cleaned with Sani wipes should remain wet for 2 minutes. 410 IAC 17-12-1(m)

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the Registered Nurse failed to ensure the patient received the right medication, route, and failed to follow agency policy to ensure all orders for IV medication contained the medication name, dose, diluent type, and amount, route, frequency, and rate. Failure to follow agency policy resulted in an IV medication error that led to the death of a patient (See tag G702); failed to ensure the Registered Nurse (RN) acted as a skilled professional and provided safe medication administration (See tag G704); and failed to ensure the agency RN documented nursing care and information within the clinical notes (See tag G716) The cumulative effect of this problem resulted in the agency having an Immediate Jeopardy for being out of compliance with Condition of Participation §484.75 Skilled Professional Services and has the likelihood to affect all current patients receiving services from this provider. The Administrator was notified of the Immediate Jeopardy on 07/14/2023 at 11:40 AM. A second removal plan was accepted on 07/18/2023. The Immediate Jeopardy was abated at the time of exit on 07/26/2023.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency staff failed to ensure safe IV medication was provided 1 of 1 closed record review (Patient #1) (RN 2); failed to ensure a complete up-to-date list of current medications were listed on the plan of care, and failed to follow agency policies and expectations for 14 of 14 record reviews with active patients receiving IV infusions. (Patient #1, #2, #3, #5, #6, #8, #9, #11, #12, #13, #14, #15, #16, #17) Findings include: 1. An undated policy titled Intravenous Administration of Medication / Solutions was provided by the Regulatory Director on 07/13/2023 at 11:39 AM. The policy indicated, but was not limited to, “ … Registered nurses may establish peripheral intravenous (IV) lines and administer organization approved IV medication and solutions under the orders of a physician (or other authorized independent practitioner). … Procedure … 2. All orders for IV medications and solutions will specify medication name and dosage, diluent type and amount, route, frequency of administration, and rate of infusion. 3. The patient receiving IV medications and solutions … should have received his/her first dose of prescribed medicine in a hospital setting, in a physician’s office, or under the supervision of a physician or [Hospice name], without evidence of allergic reaction, unless prior approval is obtained by consultation with the Clinical Supervisor and Ordering Physician. A. When it has been determined that the first dosages of medication and solutions can be given in the home without prior administration, the nurse will remain in the home for at least 30 minutes after discontinuing the IV infusion. … 7. Only medications and solutions that are prepared by a pharmacy and are properly labeled with patient’s name, name of drug, dosage, dilution, date of preparation, expiration date, initials of preparer, and any special instructions will be administered. … Addendum 2-010.A Medications Approved / Not Approved for Intravenous Administration … Approved for Intravenous Administration: Antibiotics … * Medications not listed above that require specialty training or certification for infusion will be evaluated on a case by case basis.” 2. An undated policy titled Anaphylaxis Protocol was provided by the Regulatory Director on 07/13/2023 at 11:39 AM. The policy indicated, but was not limited to, “ … Emergency medications will be given according to a physician’s (or other authorized independent practitioner’s) order. … During IV Medication Administration … 3. Administer medication from an anaphylaxis kit according to physician-described directions.” 3. An undated policy titled Medication Profile was provided by the Regulator Director on 07/17/2023 at 4:10 PM. The policy indicated, but was not limited to, "4. Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the specific medication. ..." 4. An undated Registered Nurse job description was provided by the Human Resource personnel on 07/18/2023 at 11:10 AM. The policy indicated, but was not limited to, “Documents nursing care and other significant information according to agency policy. … 8. Assumes responsibility for personal and professional growth. 9. Is knowledgeable regarding agency policy, procedures, and general information. A. Attends selected workshops, staff meetings, and seminars to enhance job performance & knowledge of services. … Education, Training & Experience … 2. Minimum of one year’s experience in nursing; home health or hospice experience preferred. … Standards of Service Excellence … Safety Awareness * Practices safety as a work habit.” 5. An undated policy titled, "Care Planning Process" was provided by the Regulatory Director on 7/17/2023 at 4:10 PM. The policy indicated, but was not limited to, "Based on the assessment and conclusions, the plan of care will include, but will not be limited to:" ... "Other appropriate items ... All Medications ". 6. The package insert for Prolastin-C Liquid indicated, but was not limited to, "Warnings and PreCautions" ... "Hypersensitivity Reactions" ... "If hypersensitivity symptoms occur, promptly stop Prolastin-C Liquid and begin appropriate therapy. Have Epinephrine or other appropriate therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction". 7. The package insert for Daptomycin (Cubicin) indicated but was not limited to, "Warnings and PreCautions" ... "Anaphylaxis/Hypersensitivity Reactions" ... "Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening. If an allergic reaction to CUBICIN occurs, discontinue the drug and institute appropriate therapy". 8. The clinical record for Patient #1 evidenced the following: During an interview on 07/13/2023 at 11:51 AM Registered Nurse (RN) 2 stated he/she was to give an intravenous (IV) Invanz (antibiotic) to Patient #1 and teach the caregiver on how to administer IV medication through a peripherally inserted central catheter (PICC) line as well. RN 2 stated he/she did not look at the IV medication vials/ampules names, dosage, or route prior to giving an IV medication which resulted in Patient #1’s hospitalization and death. RN 2 stated there were no instructions on how to give the IV Invanz medication and did not call Entity 1 pharmacy for instructions and clarification. RN 2 administered an IV medication other than the Invanz, Epinephrine, by IV push (rapid delivery). RN 2 did not indicate Invanz was the 1st dose and was unsure why and how Epinephrine got in the home. RN 2 indicated he/she had never had to give Epinephrine. RN 2 failed to follow agency policy to ensure the right medication, dosage, route, patient, and time are verified before administering medication. The POC (Plan of Care) for Patient #1, SOC (start of care) 6/25/2023, Certification period 6/25/2023-8/2/2023, reviewed on 7/13/2023 failed to include the following intravenous (IV) medications: Epinephrine (used to treat life-threatening allergic reactions) and Invanz (antibiotic to treat infections). Review of the Pharmacy Work Order/Compounding Record signed by Entity 1 pharmacist on 07/06/2023 indicated, but not limited to, " ... Instructions - For each Ertapenem (Invanz) [Sodium] 1 gram PWD Vial vial, reconstitute with 10 ml Sodium Chloride 0.9% 1000 ml for a resulting concentration of 0.1 Gm/ml ... 1 dose(s) per container: add 10 mls (1 Gm) reconstituted solution to each SMART-EZ 100 ml 200ml/hr container. QS with 90 ml Sodium Solution 0.9% 1000ml 0049 for a total volume of 100 mls." The Pharmacy Work Order, indicated but not limited to "Compound Instructions - Place in zip -lock bag: 3 Diphenhydramine 50 mg/ml 1 ml vials, 3 epinephrine 1:1000 (1mg/ml) amplues, 3 filter needles, 3 BD safetyglide 3ml 21 G x 1 syringe. Anaphylaxis protocol sheet" During an interview on 07/18/2023 at 1:40 PM RN 14 stated that if the first dose of an IV antibiotic was to be given in the home, Epinephrine 1 milligram (mg) ampule rescue kit will be sent to the home in a brown bag with instructions from the pharmacy. RN 14 stated each infusion company was different regarding their protocol on how Epinephrine was sent. RN 14 stated he/she thought Entity 1 pharmacy also sends Benadryl in the rescue kit. During an interview on 07/14/2023 at 1:07 PM the Regulatory Director stated the expectation was for staff to check medications with the medication profile while in the home and ensure the right medication, dosage, route, patient, and time are verified before administering medication. 9. The clinical records for Patients #2, #3, #5, #6, #8, and #9 evidenced the following: The POC for Patient #2, SOC 4/18/2023, Certification period 6/17/2023-8/15/2023 reviewed on 7/19/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency as indicated by the package insert with Prolastin therapy. The POC for Patient #3, SOC 12/6/2022, Certification period 6/4/2023-8/2/2023 reviewed on 7/18/2023 failed to include the following medications: Epinephrine ,over-the-counter Ibuprofen (used to treat fevers, pain, inflammation) and failed to include the correct dose of Prednisone (a medication used decrease inflammation). A document for Patient #3 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". The POC for Patient #5, SOC 6/21/2023, Certification period 6/21/2023-8/19/2023 reviewed on 7/17/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency as indicated by the package insert with Daptomycin (Cubicin) therapy. The POC for Patient #6, SOC 5/2/2014, Certification period 7/14/2023-9/11/2023 failed to include the anaphylaxis medication, Epinephrine. A document for Patient #6 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". The POC for Patient #8, SOC 4/13/2020, Certification period 5/28/2023-7/27/2023 was provided by the Regulatory Director on 7/17/2023 and failed to include Epinephrine. The POC for Patient #9, SOC 12/9/2022, Certification period 6/7/2023-8/5/2023 reviewed on 7/14/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency as indicated by the package insert with Prolastin therapy. 10. The clinical records for Patients #11, #12, #13, #14, #15, #16, and #17 evidenced the folllowing: The POC for Patient #11, SOC 6/14/2023, Certification period 6/14/2023-8/12/2023 failed to include the following medications: Epinephrine, Diphenhydramine capsule and injection (used to treat allergic reactions), Sodium Chloride (medication used to dilute other medications for IV (intravenous administration), Lidocaine-Prilocaine topical (used topically as numbing agent), Zemaira IV (used to treat Alpha-1-Antitrypsin Deficiency), Heparin (used to prevent blood clots), and Oxygen. A document for Patient #11 titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include anaphylaxis orders". A document for Patient #11 titled, "Client Coordination Note Report" dated 7/12/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Hung Zemaira per gravity for infusion. Port then flushed with 10 mls (milliliters) NS (normal saline) followed by 5 mls Heparin." A document for Patient #11 titled, "Physician Order" dated 7/16/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The summarized document indicated but was not limited to, a physician order for Zemaira 8,520 mg (milligrams) intravenously weekly that was back-dated to 6/14/2023. A document for Patient #11 titled, "Physician Order" dated 7/5/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The summarized document indicated but was not limited to, a physician order for Diphenhydramine 25 mg capsule, Diphenhydramine 20 mg/ml injection, Epinephrine 0.3mg/0.3ml injection, Lidocaine-Prilocaine 2.5%-2.5% topical, Oxygen, Sodium Chloride 0.9% intravenous. The POC for Patient #12, SOC 12/5/2022, Certification period 6/3/2023-8/1/2023 reviewed on 7/19/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency as indicated by the package insert with Prolastin therapy. The POC for Patient #13, SOC 12/8/2022, Certification period 6/6/2023-8/4/2023 reviewed on 7/19/2023 failed to include an anaphylactic medication readily available to administer in the event of an emergency as indicated by the package insert with Prolastin therapy. A summarized document for Patient #14 titled, "Client Coordination Note Report" dated 7/14/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document charted by RN 7 indicated but was not limited to, calling spouse of Patient #14 to verify pre-administration and anaphylactic medications in the home. Spouse verified patient continues with Tylenol and Benadryl 1 hour prior to infusion, no Epinephrine in the home. Pre-medication medications added to patient chart. The POC for Patient #15, SOC 7/14/2020, Certification period 6/29/2023-8/27/2023 failed to include ordered anaphylaxis medications, Epinephrine. A document for Patient #15 charted by RN 13, titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include Anaphylaxis Orders." The POC for Patient #16, SOC 2/6/2014, Certification period 6/19/2023-8/17/2023 failed to include ordered anaphylaxis medication, Epinephrine. A document for Patient #16 charted by RN 5, titled, "Client Coordination Note Report" dated 7/18/2023 was provided by the Regulatory Director on 7/19/2023 at 3:30 PM. The document indicated but was not limited to, "Plan of Care updated to include Anaphylaxis Orders." The POC for Patient #17, SOC 4/19/2023, Certification period 6/18/2023-8/16/2023 failed to include anaphylactic medication, Epinephrine. 11. During an observation on 07/13/2023 at 12:20 PM, the Registered Nurse was observed going over Patient #3's medications in the home. The Plan of Care failed to include over the counter Ibuprofen and Epinephrine, the correct dose of Prednisone, and Oxygen therapy, but did include Cetirizine, a medication Patient 3 was no longer taking. 12. During an interview on 7/13/2023, the Regulatory Director indicated that the Plan of Care is not updated with changes, including medication changes between certification periods. 13. During an interview on 7/13/2023 at 4:21 PM, the Regulatory Director indicated that all first-dose IV antibiotic infusions are sent an anaphylactic kit in the event of an emergency. Each pharmacy, specified by patients' individual pharmacy, sends these kits to the patient's homes. Indicated that each kit is different and could not identify what specifically was in the emergency kits. 14. During an interview on 7/20/2023 at 9:41 AM, the Clinical Supervisor indicated Patient #14 pharmacy sends Benadryl only, not Epinephrine. Indicated that Patient #18 had Epinephrine in the home, vial and syringe, but is refusing to have it removed at this time. The agency has a plan to remove all ampules where staff have to draw up Epinephrine and replace with Epi pens to avoid mistakes in the future. Patient agreed to speak with physician to obtain an order to replace current ampule of Epinephrine with pre-drawn pen, however is leaving the country soon with no definitive date when this can be done. If insurance will not cover pre-filled syringe, patient agreed to cover cost out of pocket to be in compliance. Indicated that Patient 17's Epinephrine in the home had expired, was destroyed with plan to replace.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse (RN) failed to act as skilled professional to ensure safe medication administration was provided to patients for 1 of 1 closed record review. (RN 2) (Patient #1); and failed to ensure nursing staff reviewed all current medications and perform medication reconciliations for 5 of 5 home visit observations. (RNs 1, 3, 5) (Patients #2, #3, #5, #9, #12) Findings include: 1. An undated policy titled Intravenous Administration of Medication / Solutions was provided by the Regulatory Director on 07/13/2023 at 11:39 AM. The policy indicated, but was not limited to, “ … Registered nurses may establish peripheral intravenous (IV) lines and administer organization approved IV medication and solutions under the orders of a physician (or other authorized independent practitioner). … Procedure … 2. All orders for IV medications and solutions will specify medication name and dosage, diluent type and amount, route, frequency of administration, and rate of infusion. 3. The patient receiving IV medications and solutions … should have received his/her first dose of prescribed medicine in a hospital setting, in a physician’s office, or under the supervision of a physician or [Hospice name], without evidence of allergic reaction, unless prior approval is obtained by consultation with the Clinical Supervisor and Ordering Physician. A. When it has been determined that the first dosages of medication and solutions can be given in the home without prior administration, the nurse will remain in the home for at least 30 minutes after discontinuing the IV infusion. … 7. Only medications and solutions that are prepared by a pharmacy and are properly labeled with patient’s name, name of drug, dosage, dilution, date of preparation, expiration date, initials of preparer, and any special instructions will be administered. … Addendum 2-010.A Medications Approved / Not Approved for Intravenous Administration … Approved for Intravenous Administration: Antibiotics … * Medications not listed above that require specialty training or certification for infusion will be evaluated on a case by case basis.” 2. An undated policy titled Care Planning Process provided by the Regulatory Nurse on 07/17/2023 at 4:10 PM indicated, “…A written plan of care will be…updated…as patient’s condition warrants…” 3. An undated Registered Nurse job description was provided by the Human Resource personnel on 07/18/2023 at 11:10 AM. The policy indicated, but was not limited to, “Documents nursing care and other significant information according to agency policy. … 8. Assumes responsibility for personal and professional growth. 9. Is knowledgeable regarding agency policy, procedures, and general information. A. Attends selected workshops, staff meetings, and seminars to enhance job performance & knowledge of services. … Education, Training & Experience … 2. Minimum of one year’s experience in nursing; home health or hospice experience preferred. … Standards of Service Excellence … Safety Awareness * Practices safety as a work habit.” 4. During an interview on 07/13/2023 at 11:51 AM Registered Nurse (RN) 2 stated he/she never administered Invanz (antibiotic for infection) before and did not have any instructions for the medication. RN 2 stated the caregiver of Patient #1 gave him/her 2 brown bags without labels. RN 2 stated the vials had manufacturer labels on them, but he/she did not look at them. RN 2 stated each bag contained 3 vials and he/ she did not know 3 of the 6 vials were Epinephrine (emergency medication for allergic reactions). RN 2 did not contact the physician or pharmacy for instructions on administering the antibiotic. RN 2 stated he/she was unaware Epinephrine was in the home and was unsure why it would be in the home. RN 2 stated he/she gave Epinephrine IV push (medication delivered in a syringe in seconds into the bloodstream) instead of the Invanz IV antibiotic. RN 2 stated he/she had never given Epinephrine before or administered CPR (Cardiopulmonary Resuscitation). RN 2 was unable to recall the amount of time that elapsed from the patient becoming pulseless to the time CPR was initiated. RN 2 stated he/she did not verify the medication, dosage, or route prior to administration. RN 2 failed to be knowledgeable about agency policies on safe IV medication delivery which resulted in the death of Patient #1. Documentation received from the patient's pharmacy on 07/26/2023 indicated 1 brown bag contained 3 vials of epinephrine and the other brown bag contained 3 vials of diphenhydramine (used to treat an allergic reaction). The Invanz was not included in the 6 vials. The Invanz was delivered in the form of an Intravenous Medication Ball that was to be removed from the refrigerator 6 hours prior to administration and given over 30 minutes. A review of Infusion Referral Form signed by [physician name] on 07/05/2023 that indicated Patient #1 had not received the medication [Invanz] previously and that an anaphylaxis kit was required. During an interview on 07/14/2023 at 1:07 PM the Regulatory Director stated the expectation was for staff to check medications with the medication profile while in the home and ensure the right medication, dosage, route, patient, and time are verified before administering medication. 5. During a home visit observation with Patient #5 on 07/17/2023 at 9:55 AM RN 3 failed to review all current medications or reconcile the resident’s medication regime. During an interview Patient 5 indicated the agency did not provide a comprehensive medication list and was observed to have HCTZ (Hydrochlorothiazide) (a diuretic medication) on hand. Patient #5 indicated she had only been taking the Toprol (a cardiac medication) once daily and had not taken the HCTZ since returning home from the hospital in June of 2023, but was taking Tylenol Extra Strength two tabs twice daily. The physician orders included, but were not limited to, an order for Metoprolol (Toprol) 25 mg tablet 3 tablets twice daily, but did not include orders for Tylenol ES or HCTZ. RN 3 indicated she would update the physician for clarification and the plan of care as soon as possible. 6. During a home visit observation on 07/17/2023 at 1:30 PM Patient #12 indicated she had an allergy to adhesives. The clinical record did not indicate Patient #12 had an allergy to adhesives and RN 5 failed to ensure the primary care provider was notified or the clinical record was updated to include the allergy. 7. During a home visit observation with Patient #2 on 07/18/2023 at 9:40 AM RN 1 failed to review all current medications or reconcile the resident’s medication regime. During an interview Patient #2 indicated the agency did not provide a comprehensive medication list, but a couple of months ago she had started taking an Iron supplement daily. RN 1 indicated she had not updated the plan of care, but would as soon as possible. 8. During an interview on 07/19/2023 at 4:19 PM the Regulatory Director, who accompanied the surveyors on each home visit, confirmed that staff was not ensuring patient plans of care were current and medication reconciliation were being done.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency Registered Nurse (RN) failed to document nursing care and information within the clinical notes for 1 of 1 closed record reviews. (RN 2) (Patient #1) An undated Registered Nurse job description was provided by the Human Resource personnel on 07/18/2023 at 11:10 AM. The policy indicated, but was not limited to, “Documents nursing care and other significant information according to agency policy. … 8. Assumes responsibility for personal and professional growth. 9. Is knowledgeable regarding agency policy, procedures, and general information. A. Attends selected workshops, staff meetings, and seminars to enhance job performance & knowledge of services. … Education, Training & Experience … 2. Minimum of one year’s experience in nursing; home health or hospice experience preferred. … Standards of Service Excellence … Safety Awareness * Practices safety as a work habit.” Review of Patient #1’s clinical record, start of care (SOC) date 06/25/2023, certification date 06/25/2023 to 8/23/2023, included a Plan of Care (POC) with no orders for Epinephrine. Review of Patient #1’s clinical record indicated a physician order dated 07/06/2023 at 11:30 AM signed by RN 8 and RN 12 for a prn skilled nurse visit to administer the 1st dose of Invanz (antibiotic) in Patient #1’s home on 07/07/2023 and pharmacy to fax detailed orders. The physician order did not indicate an Epinephrine order. A physician order dated 07/06/2023 at 3:23 PM indicated Invanz 1 milligram (mg) every 12 hours IV via peripherally inserted central catheter (PICC) signed by RN 7 and RN 13. The physician order did not indicate an Epinephrine order. On 07/07/2023 the EMR indicated a home visit was made on 07/07/2023. No information was recorded within the visit note for 07/07/2023. The agency failed to document nursing care and medication orders within the clinical note. 410 IAC 17-14-1(a)(1)(E)-RN

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to provide overall direction and leadership of agency services and failed to ensure the agency met all rules and regulations for recertification for 1 of 1 home health agency. Findings include: 1. A June 2019 Chief Executive Officer (CEO) job description was provided by the Human Resource on 07/18/2023 at 3:00 PM. The job description indicated, but was not limited to, "Chief Executive Officer ... Job Duties ... 1. Responsible for administration and management of agency operations. ... Oversees negotiation all contracts and agreements for provision of services. 4. ... B. Responsible for assuring that education is provided to management staff to improve techniques of management. ... 7. Complies with agency policy and procedures, ... 9. Oversees VNA, Inc. compliance with all federal, state, and local laws, and licensing rules and regulations." 2. The administrator failed to ensure agency failed to investigate a complaint regarding treatment/care inappropriately furnished (see tag G480) that resulted in the death of a patient (see tag G472). Failed to follow through per agency policy to investigate, analyze, and document the complaint (see tags G470, G484). Failure to follow agency policy resulted in the death of one patient (Patient #1) on 07/07/2023 related to IV (intravenous) medication administration. The failure of the quality team to investigate, analyze, and address the 07/07/2023 incident has the potential to cause further serious harm, hospitalization, and death to all current patients and any new patient admissions. 3. The administrator failed to ensure patients received the right medication, route, and failed to follow agency policy to ensure all orders for IV medication contained the medication name, dose, diluent type, and amount, route, frequency, and rate. Failure to follow agency policy resulted in an IV medication error that led to the death of a patient (See tag G702); failed to ensure the Registered Nurse (RN) acted as a skilled professional and provided safe medication administration (See tag G704); and failed to ensure the agency RN documented nursing care and information within the clinical notes (See tag G716) 4. The administrator failed to ensure all medications and pertinent information were included on the plan of care. (See tag G574) 5. The administrator failed to ensure staff followed agency policy on hand hygiene. (See tag G682) 6. The administrator failed to ensure the registered nurse performed nursing duties in accordance with the Indiana Nurse Practice Act. (See tag N539) 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure nursing staff received education or nurse competency was evaluated regarding the preparation and administration of undiluted epinephrine or following the five rights of medication administration for 5 of 5 nursing personnel files reviewed. (RN 2, RN 16, RN 5, RN 15, RN 1) 1. The employee file of RN 2 was reviewed on 07/14/2023. The RN job description, dated 09/12/2022, did not identify medication administration as an essential job duty. The learning summary and nurse education plan for orientation dated 09/12/2022, and the annual core competencies dated 05/11/2023, did not include information regarding the preparation and administration of undiluted epinephrine or following the five right of medication administration. 2. The employee file of RN 16 was reviewed on 07/14/2023. The nurse education plan for orientation and the skilled nursing competency checklist dated 12/15/2020 did not include information regarding the preparation and administration of undiluted epinephrine or following the five right of medication administration. 3. The employee file of RN 5 was reviewed on 07/14/2023. The annual core competencies dated 06/01/2023, did not include information regarding the preparation and administration of undiluted epinephrine or following the five right of medication administration. 4. The employee file of RN 15 was reviewed on 07/14/2023. The skilled nursing new hire competency checklist and the nurse education plan for orientation, dated 06/08/2023, and an on-site visit evaluation dated 06/27/2023 did not include information regarding the preparation and administration of undiluted epinephrine or following the five right of medication administration. 5. The employee file of RN 1 was reviewed on 07/14/2023. The annual core competencies dated 05/11/2023 did not include information regarding the preparation and administration of undiluted epinephrine or following the five right of medication administration. 6. During an interview on 07/17/2023 at 11:30 AM the Regulatory Nurse indicated the agency did not have a policy regarding educating staff on the preparation and administration of epinephrine or following the five rights of medication administration. The Regulatory Nurse indicated the agency’s expectation was for nurse’s to be knowledgeable and proficient with both tasks and the agency did not regularly provide additional education or evaluate competency regarding preparation and administration of epinephrine or following the five rights of medication administration. 7. The pharmacy contract dated 07/15/2016 indicated, “…1. [Name of pharmacy provider] Responsibilities a) Education of Home Health Agency…ii) Provide education to the staff of the Home Health Agency on proper clinical techniques and procedures as needed…” During an interview with Entity 1 pharmacy on 07/19/2023 at 3:30 PM the pharmacist indicated no documentation could be provided to show the pharmacy provided education to the HHA staff regarding preparing and administering undiluted epinephrine or the five rights of medication administration.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 5/16/2023-5/19/2023 and 5/22/2023-5/23/2023 Active Census: 407 At this Emergency Preparedness survey, Visiting Nurses Association of the Wabash Valley was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102.

This visit was for a Federal Recertification and State Re-licensure survey of a Provider. Survey Dates: 5/16/2023-5/19/2023 and 5/22/2023-5/23/2023 Partially Extended Survey Announced 5/18/2023 at 4:30 P.M. 12-month Unduplicated Skilled Admissions: 2007 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. QR on 05/25/2023 by A4

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide a plan of care that had patient-specific discharge goals with measurable outcomes and patient/caregiver responses for 17 of 17 records reviewed. (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, and #17) Findings include: 1. A undated policy titled DISCHARGE CRITERIA AND PROCESS Policy No. 1-024 was provided by the Alternate Administrator on 5/22/2023 at 4:19 PM. The policy indicated, but was not limited to, "PROCEDURE…4…A. Discharge planning will identify needs the patient may have…” 2. Records reviewed for patients Patients #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, and #17 between 5/17/2023 and 5/19/2023 evidenced a statement used for every patient’s goal with no indication of how the goal was addressed with the patient/caregiver and what their response was to those interventions provided. All records reviewed failed to evidence individualized discharge planning goals on the plan of care that showed any education or training that would facilitate a timely discharge. 3. On 5/22/2023 at 4:27 P.M. an interview with the Alternate Administrator was conducted. It was indicated discharge goals were not individualized and did not show when or how discharge planning was addressed throughout the certification period. The Regulatory Director indicated this should have been done and a response documented. 410 IAC 17-13-1(a)(1)(D)(i-xiii)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to alert the physician when changes were made to the administration of a medication for 1 of 7 patient home visit observations. (Patient #11) Findings include: 1. An undated policy titled, “Infusion Therapy-Peripheral Line,” indicated the following but was not limited to, “Flushing recommendations: a. Frequency: 1) Pre- and Post-medications.” 2. During an observation on 5/17/2023 at 12:25 PM, Registered Nurse (RN 1), inserted the IV(Intravenous) catheter (a small tube used to administer medication) into Patient #11's vein, verified there was blood return, connected the IV tubing, flushed the line, then began the administration of Prolastin (a medication used to treat alpha-antitrypsin deficiency) via gravity. It was noted infusion drip rate was slow. RN 1 then clamped the lV tubing and disconnected from the catheter, removed the blue hub between the IV tubing and the IV catheter, then reconnected it to allow the infusion to begin again. It was noted the rate of the infusion drip rate was faster after the change. Post medication infusion, the IV was removed with no post flush, then a dressing was applied. 3. The complete record for patient #11 was reviewed on 5/18/2023. In a document titled “Visit Note Report” dated 5/17/2023 RN 1 documented, “SN (Skilled Nursing) performed SNV (Skilled Nurse Visit) to infuse Prolastin. 24G (gauge) IV placed in LAC (Left antecubital) x1 stick. Positive blood return and flushes easily. Prolastin hung to gravity and infused per order. IV flushed and discontinued. Gauze with tape secured to IV site. Patient tolerated well. VS (vital signs) WNL (Within Normal Limits). No concerns at this time. The documentation failed to evidence any communication with the doctor on the adaptation made to the equipment due to malfunction, that it did not allow a post flush per agency policy, or that the flush order was not specific in detailing when and how much flush was to be given for each infusion. 4. During an interview on 5/17/2023 at 12:25, RN 1 indicated that this has been an ongoing issue with this particular IV catheter. In the past, RN 1 reached out to another colleague for advice on how to handle the issue and found that removing the hub on the IV catheter resolved the slow infusion. RN 1 denied notifying agency management, the physician, or the manufacturer of the IV catheter for this ongoing concern. RN 1 indicated this issue is “hit or miss”, and typically happens every few months and when it does there can be no post-IV flush once the medication has completed infusion due to the hub being removed. 5. During an interview on 5/18/2023 at 1:40 P.M. the Alternate Administrator indicated the nurse should have clarified the order from the physician for this patient and should have communicated with the physician on the treatment and inability to provide a post flush. 410 IAC 17-13-1(a)(2)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the nurse failed to accurately document the administration of treatment for 1 of 7 patients observed during home visits. (Patient #11) Findings include: 1. 1. An undated policy titled MONITORING PATIENT’S RESPOSE/REPORTING TO PHYSICIAN Policy No. 1-012 was provided y the Alternate Administrator on 5/22/2023 at 4:19 PM. The policy indicated, but was not limited to, "POLICY…Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient…PROCEDURE…3…E. Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions and limitations…” 2. An undated policy titled Infusion Therapy-Peripheral Line indicated the following but was not limited to, “Flushing recommendations: a. Frequency: 1) Pre- and Post-medications…” 3. The complete record for patient #11 was reviewed on 5/18/2023. In a document titled “Visit Note Report” dated 5/17/2023 Registered Nurse (RN 1) documented, “SN (Skilled Nursing) performed SNV (Skilled Nurse Visit) to infuse Prolastin. 24G (gauge) IV (Intravenous) placed in LAC (Left antecubital) x1 stick. Positive blood return and flushes easily. Prolastin hung to gravity and infused per order. IV flushed and discontinued. Gauze with tape secured to IV site. Patient tolerated well. VS (vital signs) WNL (Within Normal Limits). No concerns at this time. The documentation failed to evidence any communication with the doctor on the adaptation made to the equipment due to malfunction, that it did not allow a post flush per agency policy, or that the flush order was not specific in detailing when and how much flush was to be given for each infusion. 4. During an observation on 5/17/2023 at 12:25 PM, Registered Nurse (RN 1), inserted the IV (intravenous) catheter (a small tube used to insert medication directly into the vein), verified blood return, connected the IV tubing, flushed the line, then began the administration of Prolastin (a medication used to treat alpha-antitrypsin deficiency) via gravity. It was noted infusion drip rate was slow. RN 1 then clamped the lV tubing and disconnected from the catheter, removed the blue hub between the IV tubing and the IV catheter, then reconnected it to allow infusion to begin again. It was noted the rate of the infusion drip rate was faster after the change. Post medication infusion, the IV was removed with no post flush, then a dressing was applied. 5. During an interview on 5/17/2023 at 12:25 PM, RN 1 indicated that this has been an ongoing issue with this particular IV catheter. In the past, RN 1 reached out to another colleague for advice on how to handle the issue and found that removing the hub on the IV catheter resolved the slow infusion. RN 1 denied notifying agency management, the physician, or the manufacturer of the IV catheter for this ongoing concern. RN 1 indicated this issue is “hit or miss”, and typically happens every few months and when it does there can be no post-IV flush once the medication has completed infusion due to the hub being removed. 6. During an interview with the Alternate Administrator on 5/18/2023 at 1:40 PM. it was indicated the documentation in the visit note did not accurately represent what occurred during the observed visit on 5/17/2023. 410 IAC 17-14-1(a)(1)(E)-RN