Every finding on record at Monarch Home Health Inc

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. 05/08/2023 - 05/12/2023 Census: 6 active patients At this Emergency Preparedness survey, Monarch Home Health Inc. was not found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Emergency Preparedness Plan was reviewed and updated at least every 2 years for 1 of 1 Emergency Preparedness Program review. Findings include: An undated policy titled Emergency Preparedness Management Policy was provided by the Alternate Administrator on 05/11/2023 at 2:49 PM. The policy indicated, but was not limited to, “Purpose … To identify the process for disaster readiness and emergency management … “ Review of the Emergency Preparedness binder on 05/11/2023 failed to evidence documentation of when a review and update occurred. Review of the Governing Body Meeting Minutes dated 02/13/2023, 11/13/2022, 07/13/2022, and 01/13/2022 did not indicate a review or update of the Emergency Preparedness program. Review of the agency Quality Assessment Performance Improvement (QAPI) for the years 2023 and 2022 did not indicated a review or update of the Emergency Preparedness Program. During an interview on 05/11/2023 at 3:15 PM the Emergency Preparedness binder was reviewed along with the Administrator and Alternate Administrator. The Administrator indicated the agency Emergency Preparedness program was reviewed and updated but was unsure of exact date.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct one Emergency Preparedness test annually and conduct a full-scale exercise as least every two years for 1 of 1 Emergency Preparedness Program review. Findings include: An undated policy titled Emergency Preparedness Management Policy was provided by the Alternate Administrator on 05/11/2023 at 2:49 PM. The policy indicated, but was not limited to, “Training: Agency staff members will participate in an annual desktop drill to determine the effectiveness and efficiency of the current plan and any forms developed for use in a disaster.” The review of the agency Emergency Preparedness Program that was provided by the Administrator on 05/09/2023 failed to evidence documentation that a table-top or full-scale exercise was completed for the past three years. During an interview on 05/11/2023 at 2:30 PM the Administrator indicated he/she did not conduct or document any table-top or full-scale exercise for the agency.

This survey was for a Federal Recertification and State Re-Licensure of a Home Health Provider. 05/08/2023 - 05/12/2023 12-Month Unduplicated Skilled Admissions: 8 Partially Extended Survey Announced 05/10/2023 at 12:30 PM. These deficiencies reflect State findings in accordance with 410 IAC 17 QA completed on 5/18/2023 by A4

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients received all services outlined in the plan of care for 1 of 2 closed record reviews. (Patient #8) Findings include: A review of an undated Monarch Home Health Patient Handbook was provided by the Administrator on 05/08/2023 at 10:25 AM. The patient handbook indicated, but was not limited to, “Section III: Patient Rights and Responsibilities … The patient has the right to receive all services outlined in the plan of care.” The clinical record for Patient #8, Start of Care (SOC) date 12/10/2020, certification period 04/04/2022 to 06/02/2022, was reviewed on 05/09/2023. The record included a Plan of Care (POC) with orders for Skilled Nursing (SN) services up to 5 hours a visit every 3 weeks for 9 weeks. A review of a 03/31/2022 Supplemental Documentation indicated Patient #8 received his/her last home infusion of Gammagard for a compromised immune system. The document indicated Patient #8 received his/her first infusion of Octagam (immune system medication) on 03/29/2022 at the Cancer Center. A review of a 05/31/2022 Recertification Assessment indicated SN services were needed for infusion. A review of a 05/31/2022 60-day Summary indicated Insurance no longer covered Gammagard. Patient #8 received Octagam on 03/29/2022 at the Cancer Center and was scheduled to receive the next infusion at the Cancer Center on 06/02/2022. Patient #8 indicated he/she would prefer to receive their infusions at home. A review of a 07/05/2022 Communication Note indicated the agency would discharge Patient #8 from the agency due to an unsigned POC. The agency failed to provide SN visits as indicated on the POC since 02/02/2022. The agency failed to obtain a physician clarification order to hold patient services or discharge the patient. During an interview on 05/09/2023 at 10:10 AM the clinical record was reviewed along with the Administrator. The Administrator indicated the agency did not write a hold services order or discharge order for Patient #8. The Administrator confirmed SN visits had not been conducted since 02/02/2022.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observations, record review, and interview, the agency failed to maintain accurate and up-to-date plan of care documents in home for patients and in patients charts for 1 of 3 home visit observations. (Patient #3) Findings include: An undated policy titled Plan of Care was provided on 05/09/2023 at 10:45 AM, by Alternate Administrator. The policy indicated but was not limited to, “The Plan of Care shall be completed in full to include: … o. medications: dose/frequency/route … 8. All new orders received during the certification period must be added to current plan of care …” The clinical record for Patient #3, for the certification period of 03/29/2023 to 05/27/2023, was reviewed on 05/09/2023. The record included: A faxed order from the physician indicating an addendum being made to the Plan of Care (POC). The addendum indicated a 4/25/2023 dated new order for 12.5 mg (milligrams) of Hydrochlorothiazide (a medication used for high blood pressure and/or swelling) one tablet, once a day. A 05/08/2023 updated POC that included the addition of a new medication, fenofibrate (a medication used to treat abnormal lipid levels). No other medications were added to the updated POC. On 05/09/2023 at 11:57 AM, Registered Nurse (RN 1) was observed during a home visit with Patient #3. RN 1 filled the patient's medication holder for the week. RN 1 used a medication profile list that included the medication Hydrochlorothiazide. Patient #3's home POC was not updated and failed to include both Hydrochlorothiazide and Fenofibrate. On 05/09/2023 at 11:57 AM, RN 1 indicated Patient #3 should have a current POC in the home. On 05/10/2023 at 10:05 AM, the Administrator indicated the staff was to update the POC in the chart and in the patient’s home when medication changes were made.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on observations, record review, and interview, the agency failed to meet standards set forth to guide handling of physician orders and failed to follow guidelines, outlined in policy, for reporting missed medication or vitals outside of ordered parameters for 2 of 3 record reviews. (Patient #3 and #6) Findings include: 1. An undated policy titled Coordination of Client Service policy was provided by the Administrator on 05/09/2023 at 2:10 PM. The policy indicated but was not limited to, “4. Monarch Home Health, Inc. will communicate with ALL physicians who are writing orders regarding the plan of care. …” 2. During a home visit on 05/08/2023 at 12:48 PM, Registered Nurse (RN) 2 was observed checking patient 6's blood pressure (BP). RN 2 indicated the patient's BP in the right arm was 187/94 and in the left arm was 158/98. RN 2 did not notify the physician of the blood pressure outside of the agency's policy parameters. The clinical record for Patient #6, Start of Care (SOC) date 03/01/2023, certification period 04/30/2023 thru 06/24/2023, was reviewed on 05/11/2023. The Plan of Care (POC) document indicated but was not limited to, "21. Additional Orders: SN to obtain vital signs … SN to notify MD for blood pressure … >160/90 …” RN 2’s Skilled Nursing Visit Note from the home visit on 05/08/2023 evidenced, "BP which was elevated a lot in right arm. Rechecked in left arm 158/98 … Will check again on 5-10-23 … “. The Patient calendar indicated the next skilled nursing (SN) visit would be on 05/15/2023 and there was not an as-needed (PRN) SN visit scheduled for 05/10/2023. 3. On 05/09/2023 at 11:57 AM, RN 1 was observed during a home visit with Patient #3. RN 1 did not administer an intramuscular injection (IM) of B-12 (vitamin). RN 1 instructed the patient, B-12 medication was not available for pickup at the pharmacy and would not be administered during the visit. On 05/11/2023 the POC and the 05/08/2023 skilled nursing visit note for patient #3 completed by RN 1.” was reviewed. The POC indicated patient #3 was to receive an IM injection of Cyanocobalamin (vitamin B-12) every 30 days. The Skilled Nursing Visit Note indicated the following, “B-12 serum not available for P/U [pick up] at pharmacy today. SN will call MD [Medical Doctor] for order to make second visit this week to administer …” On 05/09/2023 at 11:57 AM and on 05/11/2023 at 2:30 PM, RN 1 indicated Patient #3 missed their B-12 injection. On 05/09/2023, RN 1 confirmed B-12 injections would be given later in the week, and the doctor would be notified. On 05/11/2023, RN 1 indicated the physician was not notified of the missed medication and he/she did not make a request from the MD for an additional nursing visit to administer the injection. 4. On 5/09/2023 at 9:12 AM the Administrator indicated the expectation was for staff to report changes in the POC to the physician, on the same day the change occurs.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the agency coordinated services with other Entities that provided care outlined in the plan of care for 3 of 3 active record reviews with services from other Entities, with the potential to affect all active patients with outside Entity services. (Patient #2, #4, #6) Findings include: 1. An undated policy titled Coordination of Client Services was provided by the Administrator on 05/09/2023 at 2:10 PM. The policy indicated, but was not limited to, “To ensure other medical entities involved in patient’s care are kept informed of care being provided by agency so that there is no duplication of service and that patient’s needs are being met. … 6. Clients, their representatives, and other caregivers will be included in the coordination activities and will receive direct communication related to planning and change in the plan. … 12. The coordination activities are inclusive of the discharge plans. Physicians have to agree to any plan to discharge or transfer a client.” 2. The clinical record for Patient #2, Start of Care (SOC) date 04/15/2021, certification period 02/04/2023 to 04/04/2023 was reviewed on 05/11/2023. Patient #2’s Plan of Care (POC) indicated Skilled Nursing (SN) services up to 2 hours a visit 3 times a week for 9 weeks. The POC indicated Care Coordination with Entity 1, a separate licensed agency. Review of the Case Conference / Coordination of Care Notes dated 05/01/2023 and 04/03/2023 for Patient #2 failed to evidence coordination of care took place with Entity 1. 3. The clinical record for Patient #4, SOC date 07/27/2023, certification period 03/24/2023 to 05/22/2023, was reviewed on 05/10/2023. The POC indicated Care Coordination with Entity 2, a separate licensed agency. During a home visit on 05/08/2023 at 2:30 PM Registered Nurse 1 (RN 1) was observed providing care to Patient #4. At that time, Entity 2 personnel was present during the visit. RN 1 indicated he/she coordinated services with the patient and caregiver but not with other Entities. Entity 2 was not listed on the POC. Review of the Coordination Notes dated 03/21/2023 indicated Patient #4 received services 5 times a week from Entity 2. The Coordination Notes dated 03/21/2023 and 03/27/2023 failed to evidence documentation that coordination of care occurred with Entity 1 and Entity 2. 4. The clinical record for Patient #6, Start of Care (SOC) date 03/21/2023, certification period 04/30/2023 to 6/28/2023, was reviewed on 05/10/2023. Patient #6’s POC included orders for Skilled Nursing visits up to 1 hour 1 time a week for 9 weeks for medication set-up/management and medication and disease process teaching. The POC indicated Care Coordination with Entity 1, a separate licensed agency. During a home visit on 05/08/2023 at 12:48 PM, Registered Nurse 2 (RN 2) was observed providing care to Patient #6. At that time, RN 2 was asked how he/she coordinated care with Entity 1. RN 2 indicated he/she works for Entity 1 but did not reply specifically how coordination occurs. Review of the Coordination Notes dated 04/17/2023 for Patient #6 failed to evidence coordination of care with Entity 1. No Coordination notes for the current certification period. 410 IAC 17-14-1(a)(1)(F) 410 IAC 17-12-2(g)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency's Governing Body failed to approve the frequency and data collected for the Quality Assessment Performance Improvement (QAPI) program for 1 of 1 QAPI program review. Findings include: An undated policy titled Quality Assessment and Performance Improvement (QAPI) was provided by the Alternate Administrator on 05/12/2023 at 9:52 AM. The policy indicated but was not limited to, “Scope of Program … 3. The frequency and detail of the data collection must be approved by the governing body and noted in meeting minutes.” A review of the Governing Body Meeting Minutes dated 02/13/2023, 11/13/2022, 07/13/2022, and 01/13/2022 failed to indicate the Governing Body approved the frequency and detail of the data collected for the QAPI program. During an interview on 05/12/2023 at 9:15 AM the Administrator and Alternate Administrator agreed the agency did not document Governing Body's approval of the data collected for the QAPI program. 410 IAC 17-12-2(a)

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 observations, record review, and interview, the agency failed to follow standard precautions related to hand hygiene, equipment cleaning and disinfection to help prevent the spread of disease and infection for 3 of 3 home visit observations. (Patient #3, #4, #6) Findings include: 1. An undated policy titled Infection Prevention and Control Policy was provided by the Administrator on 05/10/2023 at 12:15 PM. The policy indicated, but was not limited to, “Standard precautions are … designed to …prevent… spreading infection among patients. Standard Precautions include: 1. Hand hygiene … 7. Clean and disinfected environmental surfaces … All Employees should ensure…hands are thoroughly washed and dried: … 7. Before and after any care or clinical activity 8. Before and after handling medications … Healthcare Bag Technique Procedure … 3. Once in patient’s home … clean flat hard surface to place bag … never place a … bag on floor … Use barrier… under the bag to help prevent the transmission of infection … 9. Following care: clean reusable items (blood pressure cuff, stethoscope, etc.) are returned to bag …” 2. On 05/08/2023 at 12:48 PM, Registered Nurse (RN 2) was observed during a home visit with Patient #6. RN 2 placed their nursing bag directly onto the floor, without using a barrier between the contaminated floor and the nursing bag. RN 2 failed to clean the blood pressure cuff, the oximeter (an instrument for measuring the patient's oxygen level), and the thermometer prior to and after using them on Patient #6. The contaminated items were placed back into the nursing bag. RN 2 also failed to perform hand hygiene during the home visit. 3. On 05/08/2023 at 2:30 PM, RN 1 was observed during a home visit with Patient #4. RN 1 placed the nursing bag on the floor without a barrier. The blood pressure cuff, oximeter, and thermometer were cleaned using an Equate (brand of the wipes) antibacterial hand wipe. The hand wipe manufacturer's indicated use was for cleaning of the hands; there were no instructions for cleaning equipment or surface disinfection. The equipment was returned to the nursing bag with no other disinfectant performed. 4. On 05/09/2023 at 11:57 AM, RN 1 was observed during a home visit with Patient #3. RN 1 placed the nursing bag on the floor with no barrier between the bag and the floor. The blood pressure cuff, oximeter, and thermometer were cleaned using Equate antibacterial hand wipes. The equipment was returned to the nursing bag with no other disinfectant performed after use. RN 1 then filled the patient's automatic pill dispenser without first performing hand hygiene. RN 1 proceeded to sit in a chair taking the nursing bag from the floor and placing it in the chair beside them. A barrier was not used between the nursing bag and chair. 5. On 05/10/2023 at 10:05 AM, the Administrator confirmed agency staff is to utilize proper bag technique during home visits, which includes placing a barrier between the floor and the nursing bag. The Administrator indicated hand hygiene standards were to be implemented according to standard precautions guidelines during home visits. 6. On 05/12/2023 at 9:45 AM RN 1 read the instructions on the disinfected wipe container that was used to disinfect the reusable equipment (blood pressure cuff, oximeter, thermometer). The instructions indicated, “Apply wipe thoroughly to hands as desired, allow to dry without wiping.” The manufacturer's label did not indicate the product could be used to disinfect surfaces or equipment. RN 1 agreed the wipes were not made for equipment disinfection. 410 IAC 17-12-1(m)

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 Registered Nurse (RN) failed to prepare clinical notes and ensure documentation of wound measurements and assessments were recorded in the patients’ medical record for 1 of 2 closed record reviews (RN 2) (Patient #7); and failed to record the actual time and length of patient’s home visits according to agency policy for 1 of 3 Skilled Nursing home visits. (RN 2) Findings include: 1. An undated policy titled Clinical Documentation was provided by the Administrator on 05/10/2023 at 12:15 PM. The policy indicated, but was not limited to, “1. All skilled services provided by Nursing and aides will be documented in the clinical record. Documentation will be signed, including title, times, and dated. 2. … Actual time and length of the client visit will be included in each note. 3. Additional documentation that is pertinent to the client’s care or condition may be documented on the Progress Note or Flow Sheet. … 5. Documentation of services ordered on the plan of care … incorporated into the clinical record within fourteen (14) days after the care has been provided.” 2. A 08/09/2019 Registered Nurse (RN) job description was provided by the Administrator on 05/10/2023 at 9:50 AM. The job description indicated, but was not limited to, “ … 4. … d. Documents legibly and according to Monarch Home Health, Inc. documentation guidelines and standards.” 3. The clinical record for Patient #6, Start of Care (SOC) date 03/21/2023, certification period 04/30/2023 to 6/28/2023, was reviewed on 05/10/2023. Patient #6's POC included orders for Skilled Nursing (SN) visits up to 1 hour 1 time a week for 9 weeks for medication set-up/management and medication and disease process teaching. During a home visit on 05/08/2023 at 12:48 PM, RN 2 was observed providing care to Patient #6 between 12:48 PM to 1:25 PM. At that time, confirmed with RN 2 the start and end time of Patient #6’s home visit. Review of the Skilled Nurse Visit Note dated 05/08/2023 indicated a home visit with Patient #6 took place between 1:00 PM to 2:00 PM. RN 2 failed to accurately record the actual home visit time of 12:48 PM (start time) to 1:25 PM (end time) for Patient #6. During an interview on 05/10/2023 at 10:05 AM the Administrator agreed RN 2 was to record an accurate time for patient home visits. 4. The clinical record for Patient #7, SOC date 08/04/2022, certification period 12/02/2022-01/30/2023, was reviewed on 05/10/2023. Patient #7's POC included physician orders for SN to perform wound treatments as follows: Cleanse all non-stageable injured toes with wound cleanser, then paint toes with Betadine (wound medication) then wrap with Conform dressing 2-3 times a week; Cleanse Stage 3 pressure ulcer left heel wound with wound cleanser, apply Silver Alginate (wound medication) then cover with a silicone bordered foam (bandage) 2-3 times a week; Cleanse Stage 3 pressure ulcer right ischium (part of hip bone) with wound cleanser,t then apply Silver Alginate and cover with a silicone bordered foam 2-3 times a week for 3 weeks. Review of the Skilled Nursing Visit Note dated 12/07/2023 failed to indicate measurements or an assessment of Patient #7’s left heel wounds or injured toes for the following dates: 12/19/2023, 12/12/2023,12/14/2023, 12/16/2023, 12/21/2023, 12/24/2023, 12/26/2023, 12/28/2023, 12/30/2023, 01/02/2023, 01/04/2023, 1/06/2023, 01/11/2023, 01/13/2023, 01/16/2023, 01/18/2023, 01/20/2023, 01/23/2023, 01/25/2023, and 01/27/2023. During an interview on 05/11/2023 at 12:30 PM the clinical record for Patient #7 was reviewed along with the Administrator. The Administrator indicated the Wound Clinical said Patient #7’s right great toe was healed on 12/19/2022. The Administrator indicated wound measurements are recorded on each nursing visit and agreed there were no documentation of measurements or assessments on Patient #7’s left heel wound or injured toes. 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 observations and interview, the agency failed to provide staff with proper education and guidance of handling and documenting the transportation of patient medications, for 2 of 3 home visit observations. (Patient #3 and #6) Findings include: 1. A review of Indiana Code (IC) 16-27-3-4 indicated but was not limited to, a requirement to transport drugs in accordance with written policies and procedures, to transport drugs in a sealed portable container, and to only remove a drug from the container with a written or verbal order. The code indicated home health agencies must maintain a written record of the dates and times the container is in the possession of a licensed or registered nurse and the home health agency must require the employee who possesses the container to be able to account for all of the medication. 2. On 05/08/2023 at 12:48 PM, during a home visit with Patient #6 RN 2 indicated the medication was picked up by them from the pharmacy on behalf of the patient prior to the patient’s home visit. RN 2 indicated this was their normal routine. 3. On 05/09/2023 at 11:57 AM, RN 1 was observed removing patient medication from their personal vehicle. RN 1 indicated the medication was for Patient #3. RN indicated they collect the patient's medication from the pharmacy prior to the home visit on a regular basis. 4. On 5/10/2023 at 10:30 AM, the Administrator was asked to provide a copy of the agency's patient medication transport policy. The Administrator indicated the agency did not have a policy for patient medication transport. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure staff documented wound measurements and assessments in the patient's medical record for 1 of 2 closed record reviews (Patient #7); failed to record the actual time and length of patient’s home visits according to agency policy for 1 of 3 Skilled Nursing home visits (RN 2); and staff failed to ensure the original clinical note was maintained in the patient’s medical record according to agency policy for 1 of 5 active record reviews. (RN 2) Findings include: 1. An undated policy titled Clinical Documentation was provided by the Administrator on 05/10/2023 at 12:15 PM. The policy indicated but was not limited to, “1. All skilled services provided by Nursing and aides will be documented in the clinical record. Documentation will be signed, including title, times, and dated. 2. … Actual time and length of the client visit will be included in each note. 3. Additional documentation that is pertinent to the client’s care or condition may be documented on the Progress Note or Flow Sheet. … 5. Documentation of services ordered on the plan of care … incorporated into the clinical record within fourteen (14) days after the care has been provided.” 2. An 08/09/2019 Registered Nurse (RN) job description was provided by the Administrator on 05/10/2023 at 9:50 AM. The job description indicated but was not limited to, “ … 4. Document legibly and according to Monarch Home Health, Inc. documentation guidelines and standards.” 3. The clinical record for Patient #6, Start of Care (SOC) date 03/21/2023, certification period 04/30/2023 to 6/28/2023, was reviewed on 05/10/2023. Patient #6's Plan of Care (POC) included orders for Skilled Nursing (SN) visits for up to 1 hour once a week for 9 weeks for medication set-up/management and teaching on medication and disease process. During a home visit on 05/08/2023 at 12:48 PM, RN 2 was observed providing care to Patient #6 between 12:48 PM to 1:25 PM. At that time, RN 2 confirmed the start and end time of Patient 6’s home visit. A review of the Skilled Nurse visit dated 05/08/2023 indicated a home visit with Patient #6 took place between 1:00 PM to 2:00 PM. RN 2 failed to accurately record the start and end time of Patient #6’s home visit. 4. During an interview on 05/10/2023 at 10:05 AM the Administrator indicated RN 2 was to record an accurate time for patient home visits. 5. The clinical record for Patient #7, SOC date 08/04/2022, certification period 12/02/2022-01/30/2023, was reviewed on 05/10/2023. Patient #7's POC included physician orders for the SN to perform wound treatments with the following: Cleanse all non-stageable injured toes with wound cleanser, then paint toes with Betadine (wound medication) then wrap with Conform dressing 2-3 times a week; Cleanse Stage 3 pressure ulcer left heel wound with wound cleanser, apply Silver Alginate (wound medication) then cover with a silicone bordered foam (bandage) 2-3 times a week; Cleanse Stage 3 pressure ulcer right ischium (part of hip bone) with wound cleanser, then apply Silver Alginate and cover with a silicone bordered foam 2-3 times a week for 3 weeks. Review of the Skilled Nursing Visit Note dated 12/07/2023 failed to indicate measurements or an assessment of Patient #7’s left heel wounds or injured toes for the following dates: 12/19/2023, 12/12/2023,12/14/2023, 12/16/2023, 12/21/2023, 12/24/2023, 12/26/2023, 12/28/2023, 12/30/2023, 01/02/2023, 01/04/2023, 1/06/2023, 01/11/2023, 01/13/2023, 01/16/2023, 01/18/2023, 01/20/2023, 01/23/2023, 01/25/2023, and 01/27/2023. A review of the Skilled Nursing Visit Notes indicated copies were placed in the clinical record instead or the original Skilled Visit Note. 6. During an interview on 05/11/2023 at 12:30 PM the clinical record for Patient #7 was reviewed along with the Administrator. The Administrator indicated the Wound Clinical Nurse said Patient #7’s right great toe was healed on 12/19/2022. The Administrator indicated wound measurements are recorded on each nursing visit and indicated there was no documentation of measurements or assessments on Patient #7’s left heel wound or injured toes. The Administrator indicated the SN notes were copies and not originals and he/she was unsure why the original was not placed in the patient record. The Administrator indicated the expectation was for the original SN visit note to be placed in the patient's medical record. 410 IAC 17-15-1(a)(7)