Every finding on record at Home Health Angels LLC

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: October 3, 4, 7, 8, 9, 2024 Active Census: 61 At this Emergency Preparedness survey, Home Health Angels was not found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on EP plan review and interview, the home health agency failed to ensure its EP plan included strategies for addressing emergency events identified by the risk assessment, which had the potential to affect all active patients and employees. Findings include: 1. The review of the agency’s Hazard and Vulnerability Assessment Tool, completed by Alternate Administrator on 1/04/24, indicated the agency identified the emergency events “Severe Thunderstorm … Snow Fall … Ice Storm … Temperature Extremes … Epidemic … Electrical Failure … HVAC Failure ….” as having a high probability of occurring. The emergency events “Drought … Earthquake … Transportation Failure … Fuel Shortage … Natural Gas Failure … Water Failure … Sewer Failure … Fire Alarm Failure … Communications Failure … Medical Gas Failure … Information Systems Failure … Flood, Internal … Supply Shortage … Structural Damage … Chemical Exposure … Internal Spill … Mass Casualty Incident … Hostage Situation … Civil Disturbance … Labor Action … Forensic Admission ….” were identified as having “moderate” or “low” probability of occurring. 2. The review of the agency’s EP plan failed to evidence the agency had identified and documented strategies for addressing the above emergency events identified by the risk assessment as having a probability of occurring. 3. During an interview with Alternate Administrator on 10/09/24 beginning at 5:50 PM, she reported she last reviewed the agency’s EP plan on 1/04/24, including updating the agency’s hazard and vulnerability risk assessment. Alternate Administrator reported the agency had not developed strategies for addressing emergency events identified by the risk assessment.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on EP plan review and interview, the home health agency failed to ensure its EP communication plan included name and contact information for all staff, which had the potential to affect all agency staff and patients. Findings include: 1. The review of the agency’s EP binder evidenced a document titled “Associate List” dated 5/22/2020. The list failed to evidence contact information for COTA 1, RN 2, Office Assistant 4, and Speech Therapist 1. 2. During an interview with Alternate Administrator on 10/09/24 beginning at 5:50 PM, she reported she last reviewed the agency’s EP plan on 1/04/24, however she had not reviewed and updated the communication plan to include all active employees.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on EP plan review and interview, the home health agency failed to ensure its EP communication plan included contact information for Federal, State, and local emergency preparedness staff, which had the potential to affect all agency staff and patients. Findings include: 1. The review of the agency’s EP binder evidenced a document titled “Indiana Public Health Preparedness District and District Healthcare Coalition Contacts,” dated 08/2017. The EP communication plan failed to evidence contact information for current Federal, State, and local emergency preparedness staff. 2. During an interview with Alternate Administrator on 10/09/24 beginning at 5:50 PM, she reported she last reviewed the agency’s EP plan on 1/04/24, however she had not reviewed and/or updated the communication plan to include current Federal, State, and local emergency preparedness staff.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: October 3, 4, 7, 8, 9, 2024 12-Month Unduplicated Skilled Admissions: 190 Survey was announced as fully extended on 10/07/24 at 3:08 PM. During this Federal Recertification Survey, Home Health Angels was found to be out of compliance with Conditions of Participation §484.60 Condition of participation: Care planning, coordination of services, and quality of care; §484.80 Condition of participation: Home health aide services and §484.105 Condition of participation: Organization and administration of services. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Based on the Condition-level deficiencies during the 10/09/24 survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 10/07/24. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation program for a period of two years beginning October 9, 2024, and continuing through October 8, 2026.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to conduct an initial assessment to determine the patient's immediate care and support needs within 48 hours of referral for 5 of 9 records reviewed (Patients #1, 5, 6, 7, 8, 9). Findings include: 2. Patient #1’s clinical record evidenced a referral was received on 9/09/24 and RN 1 conducted a start of care visit on 9/12/24. The record failed to evidence the reason for delay in conducting an initial assessment. During an interview on 10/07/24 beginning at 12:35 PM, RN 1 was unsure of the delay in SOC. During an interview on 10/08/24 beginning at 2:45 PM, the Alternate Administrator relayed she was unsure of the delay in SOC and verified the clinical record was missing documentation of the delay. 3. Patient #5’s clinical record evidenced a referral was received on 5/03/24 and RN 1 conducted a start of care visit on 5/06/24. The record failed to evidence the reason for delay in conducting an initial assessment. During an interview on 10/07/24 beginning at 12:55 PM, RN 1 was unsure of the delay in SOC. During an interview on 10/08/24 beginning at 2:45 PM, the Alternate Administrator relayed she was unsure of the delay in SOC and verified the clinical record was missing documentation of the delay. 4. Patient #6’s clinical record evidenced a referral was received on 2/16/24 and RN 1 conducted a start of care visit on 3/18/24. The record failed to evidence the reason for delay in conducting an initial assessment. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed the home health agency was waiting on insurance authorization and verified the clinical record for Patient #6 did not include documentation that the patient or the assisted living facility was notified of the delay. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 was unsure of the delay in SOC and relayed the delay should have been documented in the clinical record for Patient #6. 5. Patient #7’s clinical record evidenced a referral was received on 2/13/24 and RN 1 conducted a start of care visit on 3/18/24. The record failed to evidence the reason for delay in conducting an initial assessment. During an interview on 10/08/24 beginning at 3:24 PM, the Alternate Administrator relayed the home health agency was waiting on insurance authorization and verified the clinical record for Patient #7 did not include documentation that the patient or the assisted living facility was notified of the delay. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 was unsure of the delay in SOC and relayed the delay should have been documented in the clinical record for Patient #7. 410 IAC 17-14-1(a)(1)(A) Findings include: 1. Agency policy “Initial Patient Assessment” indicated a Registered Nurse (RN) should an initial assessment visit within 48 hours of referral or within 48 hours of the patient’s return home. 6. Patient #8’s clinical record evidenced a referral was received on 7/08/24 and RN 2 conducted a start of care visit on 7/12/24. The record failed to evidence the reason for delay in conducting an initial assessment. During an interview with Alternate Administrator on 10/08/24 beginning at 1:08 PM, she reported RN 2 was currently on leave from the agency.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to conduct a comprehensive assessment which included an evaluation for all referred services within 5 days of the start of care for 2 of 3 records reviewed with SOC in the last 3 months (Patient #1 and 8). Findings include: 2. Patient #1’s clinical record evidenced a referral was received for PT, OT and SN services on 9/09/24. RN 1 conducted a SOC visit on 9/12/24 and created a POC which failed to include the OT evaluate and treat order. The record evidenced an OT Evaluation was completed on 9/27/24, fifteen days after SOC, by OT 2. The record failed to evidence an order for the OT Evaluation. During an interview on 10/07/24 beginning at 12:35 PM, RN 1 relayed they didn’t order the OT Evaluation at the SOC to allow Patient #1 time to improve from COVID-19 symptoms and she verified the clinical record failed to evidence documentation that the physician was notified of the delay in OT services. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed they were unsure why the initial OT Evaluation was not ordered at SOC on 9/12/24. 1. Agency policy titled “Comprehensive Patient Assessment” indicated all patients were to have a comprehensive assessment completed within 5 calendar days of the start of care. 3. Patient #8’s clinical record evidenced a referral was received on 7/08/24 for PT services on 7/08/24 and Patient’s start of care date was 7/12/24. RN 2 conducted a start of care visit on 7/12/24 and created a plan of care which indicated PT was to evaluate and treat Patient. The record indicated on 7/22/24, Patient had not yet had a PT referral. Alternate Administrator obtained a second order for PT to evaluate and treat Patient. The record indicated on 7/23/24, Patient was discharged on 7/23/24 due to “expired at home.” The record failed to evidence a PT evaluation had been conducted prior to Patient’s discharge. During an interview with PT 1 on 10/09/24 beginning at 11:45 AM, he reported he had attempted multiple times to contact Patient, however Patient did not answer or return the calls. PT 1 reported on 7/23/24, he went to Patient’s home to attempt to conduct the PT evaluation, and found the coroner and police were at Patient’s home, as Patient was deceased. The record failed to evidence PT’ 1’s reported attempts to contact Patient nor attempted visit.

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 record review and interview, the home health agency failed to ensure an accurate review of all medications for 2 of 2 active records reviewed who reside in an Assisted Living Facility (ALF) (Patient #6 and 7). Findings include: 1. The undated agency policy “Medication Profile” indicated the medication profile shall be reviewed by a RN every sixty (60) days and updated whenever there is a change or discontinuation in medication. 2. Patient #6’s clinical record evidenced a start of care (SOC) on 3/18/24 and included a POC and medication profile for the certification period 9/14/24 to 11/12/24. Clinical records were obtained from Entity G during the survey. Comparison of Entity G’s current medication orders list and the home health agency’s POC medication profile evidenced the following discrepancies: a) Ipratropium-Albuterol Inhalation Solution (used to treat COPD) 0.5-2.5 (3mg/3 milliliter (ml)) daily at bedtime was listed on Entity G’s current medication list. The medication was not listed on the home health agency’s medication profile. b) Ipratropium-Albuterol Inhalation Solution (used to treat shortness of breath/wheezing) 0.5-2.5 (3mg/3ml) every 6 hours as needed was listed on Entity G’s current medication list. The medication was not listed on the home health agency’s medication profile. c) Acetaminophen with Codeine Phosphate (used to treat pain) 300-30 milligram (mg) three times a day as needed was listed on the home health agency medication profile. The medication was not listed on Entity G’s current medication list. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed they reconcile medications for Patient #6 during every recertification visit. 3. Patient #7’s clinical record evidenced a start of care (SOC) on 3/18/24 and included a POC and medication profile for the certification period 9/14/24 to 11/12/24. Clinical records were obtained from Entity G during the survey. Comparison of Entity G’s current medication orders list and the home health agency’s POC medication profile evidenced the following discrepancies: a) Calcium carbonate (used to treat indigestion) 500 mg tablet was listed on Entity G’s current medication list as 2 tablets every 8 hours as needed. The home health agency’s medication profile listed the medication as a 600 mg tablet with dosing of 2 tablets daily as needed. b) Cholecalciferol (used to treat Vitamin D deficiency) 50 microgram (mcg) 2000 units was listed on Entity G’s current medication list as 50 mcg daily (2000 units). The home health agency’s medication profile listed the medication as 5000 units daily. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed they reconcile medications for Patient #7 during every recertification visit. 4. During the entrance conference on 10/03/24 beginning at 9:58 AM, the Alternate Administrator relayed medications should be reconciled during every visit. 410 IAC 17-14-1(a)(1)(B)

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the therapy evaluation was completed within 5 days of the recertification for 4 of 4 active records reviewed with a therapy recertification (Patient #3, 4, 6 and 7). Findings include: 1. Patient #3’s clinical record evidenced a SOC on 4/23/24 and a recertification period of 8/21/24 to 10/19/24. OT and PT Evaluations were completed on 8/24/24 by OT 2 and PT 1, three days after the recertification period began. The record failed to include the OT and PT recertification evaluations were performed within 5 days of the 8/21/24 recertification date. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 relayed the PT evaluation should have been done within 5 days of the recertification and he was unsure why the evaluation was late. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed OT recertification should be done every 60 days, and he was unsure if it was completed within that timeframe. 2. Patient #4’s clinical record evidenced a SOC on 5/02/23 and a recertification period of 8/24/24 to 10/22/24. An OT Evaluation was completed on 8/17/24 by OT 2, seven days before recertification period began. The record failed to include an OT recertification evaluation was performed within 5 days of the 8/24/24 recertification date. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed OT recertification should be done every 60 days, and he was unsure why it was not completed within that timeframe. 3. Patient #6’s clinical record evidenced a SOC on 3/18/24 and a recertification period of 9/14/24 to 11/12/24. An OT Evaluation was completed on 9/07/24 by OT 2, seven days before recertification period began and a PT Evaluation was completed on 9/14/24 by PT 1, the first day of the recertification period. The record failed to include OT and PT recertification evaluations were performed within 5 days of the 9/14/24 recertification date. During an interview on 10/09/24 beginning at 10:36 AM, PT 1 relayed he was unsure why the evaluation was late. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed he the OT evaluation was done early because he usually only works on Saturday. 4. Patient #7’s clinical record evidenced a SOC on 3/18/24 and a recertification period of 9/14/24 to 11/12/24. An OT Evaluation was completed on 8/31/24 by OT 2, fourteen days before the recertification period. The record failed to include the OT recertification evaluation was performed within 5 days of the 9/14/24 recertification date. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed he completes the reevaluation visits when he is available, usually on Saturdays. 410 IAC 17-14-1(a)(1)(B)

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to conduct a ROC re-evaluation for all services within 48 hours from a patient’s return home after hospitalization for 1 of 2 records reviewed of a patient who was hospitalized (Patient #9). Findings include: 1. Agency policy “Comprehensive Patient Assessment” indicated when a client was admitted to an inpatient facility for more than 24 hours, a resumption of care assessment would be completed within 48 hours of the patient’s discharge home. 2. Patient #9’s clinical record evidenced a start of care date of 5/16/24. PT 2 and OT 2 conducted initial evaluations on 5/18/24 and documented Patient was to receive further therapy services. The record indicated Patient was hospitalized after admission to the home health agency. RN 1 conducted a nursing ROC visit on 5/23/24. The visit note indicated Patient was discharged from the hospital on 5/21/24. The record evidenced OT 2 conducted an OT ROC visit on 5/25/24, which was 4 days after Patient’s hospital discharge. PT 2 conducted a PT ROC visit on 5/29/24, which was 8 days after Patient’s hospital discharge. The record failed to evidence a reason the PT and OT ROC visits were delayed. 3. During an interview with PT 2 on 10/09/24 beginning at 10:39 AM, he reported if a patient was hospitalized, a ROC visit should be completed within 24-48 hours of their hospital discharge, unless the therapist was unavailable, or the patient requested a delayed visit. The therapist reported the reason for a delayed visit should be entered in the medical record PT 2 could not recall the reason Patient’s ROC visit was delayed. 4. During an interview with OT 2 on 10/09/24 beginning at 11:52 PM, he reported if a patient was hospitalized, a ROC visit should be completed within 3 days of their hospital discharge. OT 2 could not recall the reason Patient’s ROC visit was delayed.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the plan of care was updated at recertification and failed to ensure the patient received services as ordered (See G572); failed to ensure the POC included measures to address all safety concerns, frequency and duration of visits to be made, patient-specific interventions, and measurable outcomes and goals (See G574); failed to ensure all orders were recorded into the POC (See G576); failed to ensure services were provided only as ordered by a physician or allowed practitioner (See G580) failed to ensure the plan of care (POC) was reviewed with the physician at start of care (SOC) and/or recertification (See G588); failed to ensure the patient/caregiver was provided with written POC information including all treatments administered (See G618) and failed to provide the patient and/or caregiver with accurate clinical manager information (See G622). Findings include: The cumulative effect of these systemic problems had the potential to impact all 61 active patients which resulted in the agency being found out of compliance with the Condition of Participation 42 CFR 484.60 Care Planning, Coordination of Services and Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the POC was updated at recertification for 4 of 4 active records reviewed with OT recertification (Patients #3, 4, 6, 7) and failed to ensure the patient received all PT and OT services as ordered in the plan of care for 1 of 1 discharged record reviewed where Patient received PT and OT services (Patient #9). Findings include: 3. Patient #3’s clinical record evidenced a recertification POC for the certification period 8/21/24 to 10/19/24. The POC included orders for an OT re-evaluation and treat per OT POC. The record evidenced an OT routine visit was completed on 8/24/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #3 and he did not collaborate with the physician after the 8/24/24 visit. 4. Patient #4’s clinical record evidenced a recertification POC for the certification period 8/24/24 to 10/22/24. The POC included orders for an OT re-evaluation and treat per OT POC. The record evidenced an OT routine visit was completed on 8/17/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #4 and he did not collaborate with the physician after the 8/17/24 visit. 5. Patient #6’s clinical record evidenced a recertification POC for the certification period 9/14/24 to 11/12/24. The POC failed to include OT orders. The record evidenced an OT Routine visit was completed on 9/07/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #6 and he did not collaborate with the physician after the 9/07/24 visit. 6. Patient #7’s clinical record evidenced a recertification POC for the certification period 9/14/24 to 11/12/24. The POC included orders for HHA visits 3 times a week for 8 weeks and an OT re-evaluation and treat per OT POC. The record failed to evidence HHA visits were completed the week of 9/08/24. The record evidenced an OT Routine visit was completed on 8/31/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 was unaware that Patient #7 did not receive HHA visits during the week of 9/08/24. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #6 and he did not collaborate with the physician after the 8/31/24 visit. 410 IAC 17-13-1(a) Findings include: 1. Agency Policy “Plan of Care” indicated all patients should have a written, individualized plan of care which was “periodically reviewed” by the ordering provider at least every 60 days. The revised plan of care should “reflect current information from the patient’s updated comprehensive assessment and contain information concerning the patient’s progress toward the measurable outcomes and goals ….” Services were to be provided as ordered by the physician. 2. Patient #9’s clinical record indicated Patient was referred for physical therapy and occupational therapy services. On 5/25/24, OT 2 conducted an OT resumption of care re-evaluation. The therapist wrote an order for 2 OT visits per week for 4 weeks, effective 5/26/24. The record indicated only 1 OT visits was conducted the week of 5/26/24 – 6/02/24. On 5/29/24, PT 2 conducted a PT resumption of care re-evaluation. The therapist wrote an order for 1 PT visit per week for 4 weeks, effective 6/02/24. The record failed to evidence Patient received a PT visit the week of 6/24/24 – 6/30/24. On 7/06/24, PT 2 conducted a PT re-evaluation of Patient. PT 2 documented Patient was going to have a cardiac stent placed on 7/08/24, and “Patient needs continued PT to work on [his/her] strength and stability to improve [his/her] balance. Patient also needs monitored after the stent placement and will be re-evaluated next week for continued PT services.” The therapist wrote an order for Patient to be re-evaluated for PT services effective 7/07/24. The record failed to evidence a PT re-evaluation of Patient was completed and failed to evidence Patient received further PT services. On 7/27/24, OT 2 conducted an OT re-evaluation of Patient. The therapist wrote an order for 1 OT visit per week for 4 weeks, effective 7/28/24. The record failed to evidence Patient received an OT visit the week of 7/28/24 – 8/03/24. On 8/24/24, OT 2 conducted an OT re-evaluation of Patient. The therapist wrote an order for 1 OT visit per week for 3 weeks, effective 8/25/24. The record failed to evidence Patient received an OT visit the week of 8/25/24 – 8/31/24. On 9/07/24, OT 2 conducted an OT re-evaluation of Patient. This was the first OT visit completed since Patient’s previous OT re-evaluation on 8/24/24. OT 2 wrote an order for Patient to be discharged from OT services due to Patient meeting goals. During an interview with PT 2 on 10/09/24 beginning at 10:39 AM, he reported if an ordered visit was not conducted, he would contact Patient’s ordering provider and document the reason for the missed visit in the record. During a follow-up interview with PT 2 on 10/09/24 beginning at 11:45 AM, he reported he did not obtain a new order for Patient’s PT services to resume after his/her cardiac stent was placed. PT 2 could not recall the reason a new order was not obtained, or the reason Patient’s PT services failed to continue. During an interview with OT 2 on 10/09/24 beginning at 11:52 PM, he reported if an ordered visit was not conducted, he would notify Patient’s nurse and send a written order to the provider. When queried on the reason for Patient’s missed visits, OT 2 stated Certified Occupational Therapy Assistant (COTA) 1 was responsible for conducting these visits. During an interview with COTA 1 on 10/09/24 beginning at 12:20 PM, she reported if a patient’s visit was unable to be conducted, she would send a missed visit order to the patient’s provider. COTA 1 reported Patient’s OT visits would occasionally be missed due to Patient not being available. The therapy assistant reported she would document her attempts to schedule Patient’s visits in the record, however the record failed to evidence these attempts and failed to evidence Patient’s physician was notified of the missed visits. During an interview with Patient #9 on 10/09/24 beginning at 10:58 AM, he/she reported they were hoping his/her therapy services would not be stopped, as he/she would have liked to continue working on their endurance and balance.

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 home health agency failed to ensure the POC included measures to address all safety concerns, frequency and duration of visits to be made, patient-specific interventions, and measurable outcomes and goals, for 9 of 9 full records reviewed (Patients #1, 2, 3, 4, 5, 6, 7, 8, 9) and 1 of 4 focused records reviewed (Patient #4). Findings include: 2. Patient #1’s clinical record included a SOC assessment completed on 9/12/24 by RN 1. The assessment indicated the Patient was a risk for falls and the medication profile evidenced the patient was taking an anticoagulant. The POC for Patient #1 for the certification period of 9/12/24 to 11/10/24, created by RN 1, failed to evidence safety measures to address patient’s risk for falls and anticoagulant precautions and failed to include interventions for SN goals. During an interview on 10/07/24 beginning at 12:35 PM, RN 1 relayed the POC for Patient #1 should have included fall safety measures and bleeding precautions and she verified the POC failed to include interventions for nursing goals. 3. Patient #2’s clinical record included a SOC assessment completed on 9/25/24 by RN 1. The assessment indicated the Patient was a risk for falls and the medication profile evidenced the patient was taking an anticoagulant. The POC for Patient #2 for the certification period of 9/25/24 to 11/23/24, created by RN 1, failed to evidence safety measures to address patient’s risk for falls and anticoagulant precautions and failed to include interventions for SN goals. During an interview on 10/07/24 beginning at 12:42 PM, RN 1 relayed the POC for Patient #2 should have included fall safety measures and bleeding precautions and she verified the POC failed to include interventions for nursing goals. 4. Patient #3’s clinical record included a recertification assessment completed on 8/16/24 by RN 1. The assessment indicated the Patient was a risk for falls and the medication profile evidenced the patient was taking an anticoagulant. The recertification POC for Patient #3 for the certification period of 8/21/24 to 10/19/24, created by RN 1, failed to evidence safety measures to address patient’s risk for falls and anticoagulant precautions and failed to include interventions for SN goals. During an interview on 10/07/24 beginning at 12:47 PM, RN 1 relayed the POC for Patient #3 should have included fall safety measures and bleeding precautions and she verified the POC failed to include interventions for nursing goals. 5. Patient #4’s clinical record included a recertification assessment completed on 8/22/24 by RN 1. The assessment indicated the Patient was a risk for falls and the medication profile evidenced the patient was taking an anticoagulant. The recertification POC for Patient #4 for the certification period of 8/24/24 to 10/22/24, created by RN 1, failed to evidence safety measures to address patient’s risk for falls and anticoagulant precautions and failed to include interventions for SN goals. During an interview on 10/07/24 beginning at 12:51 PM, RN 1 relayed the POC for Patient #4 should have included fall safety measures and bleeding precautions and she verified the POC failed to include interventions for nursing goals. 6. Patient #5’s clinical record evidenced an admission diagnosis of Type 2 Diabetes Mellitus and included a ROC assessment completed on 9/02/24 by RN 1. The ROC assessment indicated the Patient was a risk for falls and the medication profile evidenced the patient was taking diabetic medications. The recertification POC for Patient #5 for the certification period of 9/03/24 to 11/01/24, created by RN 1, failed to evidence safety measures to address patient’s risk for falls and diabetic precautions and failed to include interventions for SN goals. During an interview on 10/07/24 beginning at 12:55 PM, RN 1 relayed the POC for Patient #5 should have included fall safety measures and diabetic precautions and she verified the POC failed to include interventions for nursing goals. 7. Patient #6’s clinical record included a recertification assessment completed on 9/09/24 by RN 1. The assessment indicated the Patient was a risk for falls. The recertification POC for Patient #6 for the certification period of 9/14/24 to 11/12/24, created by RN 1, failed to evidence safety measures to address patient’s risk for falls and failed to include interventions for SN goals. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed the POC for Patient #6 should have included fall safety measures and she verified the POC failed to include interventions for nursing goals. 8. Patient #7’s clinical record included a recertification assessment completed on 9/09/24 by RN 1. The assessment indicated the Patient was a risk for falls. The recertification POC for Patient #7 for the certification period of 9/14/24 to 11/12/24, created by RN 1, failed to include all DME ordered for the patient, failed to evidence safety measures to address patient’s risk for falls and failed to include interventions for SN goals. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed the POC for Patient #7 should have included fall safety measures and she verified the POC failed to include all DME ordered for the patient and failed to include interventions for nursing goals. 410 IAC 17-13-1(a)(1)(C) 1. Agency policy “Plan of Care” indicated each patient should have an individualized, written plan of care which must include “… the frequency and duration of visits to be made … all medications and treatments … safety measures to protect against injury … patient-specific interventions … measurable outcomes and goals ….” 9. Patient #8’s clinical record included a start of care assessment completed on 7/12/24 by RN 2. The assessment indicated Patient was a risk for falls. Patient’s plan of care for the initial certification period of 7/12/24 – 9/09/24, created by RN 2, failed to evidence safety measures to address patient’s risk for falls. During an interview with Alternate Administrator on 10/08/24 beginning at 1:08 PM, she reported RN 2 was currently on leave from the agency. 10. Patient #9’s clinical record included a recertification visit conducted on 7/10/24 by RN 1. The assessment indicated Patient was at risk for falls. Patient’s plan of care for the recertification period of 7/15/24 – 9/12/24, created by RN 1, failed to evidence safety measures to address Patient’s risk for falls. The POC indicated Patient’s medications included Clopidogrel (a blood thinner used to decrease a patient’s risk of heart attack and/or stroke). The POC failed to evidence safety measures to address Patient’s increased risk for bleeding with use of this medication. The POC indicated the nursing goals included Patient’s pain would be “controlled” throughout the certification period. The POC failed to evidence an individualized, measurable goal for Patient’s pain. During an interview with RN 1 on 10/09/24 beginning at 10:12 AM, she reported she was unaware the plan of care should include safety measures to address a patient’s risk for falls and/or bleeding. When queried how she would measure the goal “[Patient’s] pain will be controlled,” she reported she would ask a patient if their pain was controlled, what their pain “numbers” were, and if pharmacological interventions were “controlling” pain.

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 record review and interview, the home health agency failed to ensure all orders were recorded into the POC for 1 of 1 active wound clinic patient (Patient #5). Findings include: 1. Patient #5’s clinical record included updated wound care treatment orders received from Entity M dated 10/01/24. The clinical record failed to include the updated wound care orders effective 10/01/24. 2. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed all outside orders are sent to the RN who should be updating the POC immediately. 3. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed she updates orders as soon as she received them and after looking through her inbox, she relayed she had not received the updated 10/01/24 orders from the home health agency fax.

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 home health agency failed to ensure services were provided only as ordered by a physician or allowed practitioner for 6 of 7 active patient records reviewed (Patient #1, 3, 4, 5, 6 and 7). Findings include: 1. The undated agency policy “Physician Orders” indicated all medications, treatments and services provided to patient must be ordered by a physician and when the nurse or therapist receives a verbal order from the physician, he/she shall write the order as given and then read the order back to the physician verifying that the person receiving the order heard it correctly and interpreted the order correctly. 2. Patient #1’s clinical record included a POC for certification period 9/12/24 to 11/10/24 with orders for SN visit frequencies of 1 visit every week effective 9/15/24 and a PT visit frequency of 1 visit for Eval and treat effective 9/12/24. The record evidenced SN visits were performed on 9/16/24 and 9/23/24 and PT visits were performed on 9/18/24, 9/24/24 and 9/26/24. The clinical record for Patient #1 failed to include a verbal or signed written order for the SN and PT frequencies was obtained prior to the above visits performed. During an interview on 10/07/24 beginning at 12:35 PM, RN 1 relayed they thought they spoke with the physician during the SOC and she faxed the POC to the physician for signature. The clinical record for Patient #1 failed to include documentation of collaboration with the physician for SOC orders. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 verified the clinical record for Patient #1 did not include any documentation with the physician and they did not create a verbal order for the PT POC and frequencies. 3. Patient #3’s clinical record included a recertification POC for certification period 8/21/24 to 10/19/24 with orders for an OT visit for Eval and treat. The record evidenced an OT evaluation visit was completed on 8/24/24 and OT visit was performed on 8/28/24. The clinical record for Patient #3 failed to include a verbal or signed written order for the OT frequencies was obtained prior to the above visits performed. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he there were no changes in Patient #3’s needs and he faxed the OT frequency order to the physician for signature. 4. Patient #4’s clinical record included a recertification period of 8/24/24 to 10/22/24 with orders for SN visit 1 time a week for 8 weeks and PT and OT visit frequencies of 1 visit for Eval and treat. The record evidenced SN visits were performed on 8/28/24, 9/05/24, 9/12/24 and 9/18/24. PT visits were performed on 8/29/14, 9/04/24 and 9/11/24 and OT visits were performed on 8/29/14, 9/05/24, 9/14/24 and 9/19/24. The clinical record for Patient #4 failed to include a verbal or signed written order for the SN, PT and OT frequencies was obtained prior to the above visits performed. During an interview on 10/07/24 beginning at 12:51 PM, RN 1 relayed the POC for Patient #4 was faxed to physician for signature and a verbal order was not received. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 verified the clinical record for Patient #4 did not include any documentation with the physician and they did not create a verbal order for the PT POC and frequencies. PT 2 relayed the PT recertification orders were faxed to the physician. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he faxed the OT frequency order to the physician for signature. 5. Patient #5’s clinical record evidenced a ROC on 9/02/24 and a recertification period of 9/03/24 to 11/01/24 with orders for SN visits 2 times a week for 1 week and them 3 times a week for 8 weeks. The record evidenced a SN visit was performed on 9/03/24. The clinical record for Patient #5 failed to include a verbal or signed written order for the SN frequencies was obtained prior to the above visit performed. During an interview on 10/07/24 beginning at 12:55 PM, RN 1 relayed she was unsure if she collaborated with the physician for Patient #5’s ROC orders and the clinical record did not include any documentation. 6. Patient #6’s clinical record evidenced a recertification POC for 9/14/24 to 11/12/24 with orders for SN visit frequencies of 1 visit every month; PT visit frequency of 1 visit for Eval and treat per PT POC and OT visit frequency of 1 visit for Eval and treat per OT POC. The record evidenced an OT was performed on 9/15/24 and HHA visits were performed on 9/17/24, 9/18/24, 9/19/24, 9/24/24, 9/25/24, 9/26/24, 10/01/24, 10/02/24 and 10/03/24 without orders. The clinical record for Patient #6 failed to include a verbal or signed written order for the POC frequencies was obtained prior to the above visits performed and failed to include documentation with the physician regarding the OT frequency orders. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed they did not collaborate with the physician for Patient #6’s recertification POC and the POC was just faxed to the physician for signature. She was unsure why the HHA frequencies were not on the POC. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed he did not collaborate with the physician for the recertification, and he faxed the OT frequency order to the physician for signature. 7. Patient #7’s clinical record evidenced a recertification period of 9/14/24 to 11/12/24 with orders for SN visit frequencies of 1 visit every month; OT visit frequency of 1 visit for Eval and treat per OT POC and HHA visit 3 times a week for 7 weeks. The record evidenced an OT visit was performed on 9/21/24 and HHA visits were performed on 9/17/24, 9/18/24 and 9/19/24. The clinical record for Patient #7 failed to include a verbal or signed written order for the POC frequencies was obtained prior to the above visits performed and failed to include documentation with the physician regarding the OT frequency orders. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed they did not collaborate with the physician for Patient #7’s recertification POC and the POC was just faxed to the physician for signature. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed he did not collaborate with the physician for the recertification, and he faxed the OT frequency order to the physician for signature. 410 IAC 17-13-1(a)

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the patient/caregiver was provided with written POC information including all treatments administered by the agency for 3 of 3 home visits observed (Patient #1, 2, and 3). Findings include: 1. Patient #1’s clinical record evidenced a SOC on 9/12/24. During a home visit observation with Patient #1 on 10/03/24 beginning at 3:27 PM, the home health agency’s folder was reviewed and failed to evidence the home health agency had provided Patient #1 a copy of the current POC and treatment orders. 2. Patient #2’s clinical record evidenced a SOC on 9/25/24. During a home visit observation with Patient #2 on 10/04/24 beginning at 8:50 AM, the home health agency’s folder was reviewed and failed to evidence the home health agency had provided Patient #2 a copy of the current POC and treatment orders. 3. Patient #3’s clinical record evidenced a SOC on 4/23/24. During a home visit observation with Patient #3 on 10/04/24 beginning at 1:03 PM, the home health agency’s folder was reviewed and failed to evidence the home health agency had provided Patient #3 a copy of the current recertification POC and treatment orders. 4. During an interview on 10/08/24 beginning at 1:49 PM, the Alternate Administrator relayed the patient should be given a copy of the POC at the next visit after the POC has been created.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, document review and interview, the home health agency failed to provide the patient and/or caregiver with accurate clinical manager information for 3 of 3 active patients with home visit observations (Patient #1, 2 and 3). Findings include: 1. During a home visit observation with Patient #1 on 10/03/24 beginning at 3:27 PM, the home health agency’s folder was reviewed and failed to evidence the correct name and contact information of the clinical manager. 2. During a home visit observation with Patient #2 on 10/04/24 beginning at 8:50 AM, the home health agency’s folder was reviewed and failed to evidence the correct name and contact information of the clinical manager. 3. During a home visit observation with Patient #3 on 10/04/24 beginning at 1:03 PM, the home health agency’s folder was reviewed and failed to evidence the correct name and contact information of the clinical manager. 4. During an interview on 10/08/24 beginning at 8:23 AM, the Clinical Manager (person who was identified during the entrance conference as the Clinical Manager) relayed that she was just a consultant for the home health agency. She stated she was not the Clinical Manager and was not involved in the daily operations of the agency. 5. During an interview on 10/08/24 beginning at 1:49 PM, the Alternate Administrator verified the clinical manager listed in the home folder was inaccurate and indicated the agency folder in the patient’s home should be corrected to include the current clinical manager’s name and contact information.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to measure, document improvement actions and track quality indicators for 1 of 1 agency. Findings include: 1. The agency policy “Quality Assurance Performance Improvement-QAPI”, last revised 11/2018, indicated the program will be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. The HHA will measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care. 2. The agency’s QAPI binder, weekly whiteboard meeting notes and Governing Body minutes from the last 12 months were reviewed. The QAPI binder failed to include any data for measuring, improving or tracking quality indicators. 3. During an interview on 10/09/24 beginning at 12:40 PM, the Alternate Administrator relayed the agency does not keep QAPI meeting minutes and they were unsure if the agency was tracking any quality indicators. 4. During an interview on 10/09/24 beginning at 5:06 PM, the Administrator relayed the agency is always looking at QAPI items, however, the agency does not keep any meeting minutes of this. 410 IAC 17-12-2(a)

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 failed to ensure the Governing Body approved the frequency and detail of the data collection of the QAPI program for 1 of 1 agency. Findings include: 1. The agency policy “Quality Assurance Performance Improvement-QAPI”, last revised 11/2018, indicated the program will be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. The HHA will measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care. 2. The agency’s QAPI binder, weekly whiteboard meeting notes and Governing Body minutes from the last 12 months were reviewed. The QAPI binder failed to include meeting minutes and failed to evidence documentation of the frequency and detail of the data collection approved by the Governing Body. During an interview on 10/09/24 beginning at 12:40 PM, the Alternate Administrator relayed the agency does not keep QAPI meeting minutes and therefore the governing body has not approved the QAPI program. During an interview on 10/09/24 beginning at 5:06 PM, the Administrator relayed the agency does not keep any QAPI meeting minutes and therefore, the governing body has not approved any QAPI information. 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 observation, record review, and interview, the agency failed to ensure employees followed standards of practice for hand hygiene and bag technique to reduce the spread of infections for 2 of 3 home visit observations (Patients #2 and 3). Findings include: 1. The undated agency policy “Handwashing/Hand Hygiene” indicated hand hygiene should be performed between tasks on the same patient, after removing gloves and after touching objects that are potentially contaminated. 2. The undated agency policy “Infection Control” indicated the home health agency will follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. Standard precautions included hand hygiene and use of personal protective equipment. 3. The undated policy “Healthcare Bag Technique for Home Health Care Clinicians” indicated staff is to wash their hands if you need to re-enter the home care bag for additional supplies during patient care. To never reach into the bag with gloved hands, to remove gloves and clean hands first, utilize the antiseptic wipes or alcohol pads to clean your equipment, lay them in your clean area, to dry, prior to returning them to the bag, then wash your hands, and repack and close the healthcare bag. 4. During a home visit observation conducted with Patient #2 and COTA 1 on 10/04/24 beginning at 8:50 AM, COTA 1 was observed wearing gloves while performing an assessment and therapy exercises during the entire session with Patient #2. COTA 1 was also observed to cleanse the vitals equipment and return cleaned items to their equipment bag immediately without allowing to air dry, while wearing the same gloves. COTA 1 failed to change gloves or perform hand hygiene during the visit. During an interview on 10/07/24 beginning at 3:48 PM, COTA 1 relayed hand hygiene should have been performed before, during and after the patient session and gloves should have been changed in between patients and if soiled. 5. During a home visit observation conducted with Patient #3 and RN 1 on 10/07/24 beginning at 1:03 PM, RN 1 used the vitals equipment to obtain vital signs on Patient #3 and then sat the items on a paper towel on the table. RN 1 was observed cleaning the vitals equipment with a bleach wipe. RN 1 then sat the clean vitals equipment back on the dirty towel to air dry. During an interview on 10/07/24 beginning at 1:57 PM, RN 1 relayed the clean vitals equipment should have been placed on a clean barrier to air dry. During an interview on 10/07/24 beginning at 2:08 PM, the Alternate Administrator relayed all cleaned vitals equipment should have been placed on a clean barrier to air dry. 410 IAC 17-12-1(m)

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the OT failed to ensure a recertification OT POC was created for 4 of 4 patients who received OT services with a recertification period (Patient #3, 4, 6 and 7). Findings include: 1. The undated agency policy “Plan of Care” indicated each patient must receive home health services that are written in an individualized plan of care which is established, periodically reviewed, and signed by a doctor and all patient care orders, including verbal orders, must be recorded in the plan of care. The plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days. 2. Patient #3’s clinical record evidenced a SOC on 4/23/24 and included a recertification POC for the certification period 8/21/24 to 10/19/24. The POC included orders for an OT re-evaluation and treat per OT POC. The record evidenced OT Routine visits were completed on 8/10/24 and 8/24/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #3. 3. Patient #4’s clinical record evidenced a SOC on 5/02/23 and included a recertification POC for the certification period 8/24/24 to 10/22/24. The POC included orders for an OT re-evaluation and treat per OT POC. The record evidenced an OT Routine visit was completed on 8/17/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #4. 4. Patient #6’s clinical record evidenced a SOC on 3/18/24 and included a recertification POC for the certification period 9/14/24 to 11/12/24. The record evidenced an OT Routine visit was completed on 9/07/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #6. 5. Patient #7’s clinical record evidenced a SOC on 3/18/24 and included a recertification POC for the certification period 9/14/24 to 11/12/24. The record evidenced an OT Routine visit was completed on 8/31/24. The record failed to evidence an OT recertification POC was created and failed to include documentation of a verbal or written order for OT services to continue. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed they missed completing the recertification OT POC for Patient #6. 410 IAC 17-14-1(b)

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 home health agency failed to ensure all OT visit note documentation was completed accurately for 4 of 4 active patient records reviewed who have received OT services for at least 30 days (Patient's #3, 4, 6 and 7). Findings include: 1. Patient #3’s clinical record included documentation of OT Supervisory visits completed on 8/11/24 and 8/25/24. OT 2 failed to complete the OT Supervisory visits during the OT visits on 8/10/24 and 8/24/24 and the clinical record failed to include documentation of the date discrepancies. 2. Patient #4’s clinical record included documentation of an OT Supervisory visit completed on 8/18/24. OT 2 failed to complete the OT Supervisory visit during the OT visit on 8/17/24 and the clinical record failed to include documentation of the date discrepancy. 3. Patient #6’s clinical record included documentation of an OT Supervisory visit completed on 8/25/24. OT 2 failed to complete the OT Supervisory visit during the OT visit on 8/24/24 and the clinical record failed to include documentation of the date discrepancy. 4. Patient #7’s clinical record included documentation of an OT Supervisory visit completed on 9/02/24. OT 2 failed to complete the OT Supervisory visit during the OT visit on 8/31/24 and the clinical record failed to include documentation of the date discrepancy. 5. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he had forgot to document the OT Supervisory visits during the OT visits and he was unable to backdate the supervisory visit notes to reflect the actual visit date. 410 IAC 17-14-1(c)(5)

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the PT POC was reviewed with the attending physician and/or a verbal or written order was obtained prior to visits being performed for 5 of 5 active patient records reviewed who received PT services (Patient #1, 2, 3, 4 and 6) and failed to ensure the OT collaborated with the attending physician and/or a verbal or written order was obtained prior to visits being performed for 6 of 6 active patient records reviewed who received OT services (Patient #1, 2, 3, 4, 6 and 7). Findings include: 1. The undated agency policy “Plan of Care” indicated each patient must receive home health services that are written in an individualized plan of care which is established, periodically reviewed, and signed by a doctor and all patient care orders, including verbal orders, must be recorded in the plan of care. The plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days. 2. Patient #1’s clinical record evidenced a SOC on 9/12/24. A PT Evaluation was completed on 9/18/24 by PT 1 and an OT Evaluation was completed on 9/27/24 by OT 2. The record failed to include documentation with the physician and failed to include documentation of a verbal or written order for the PT and OT POC’s and frequency orders. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 verified the clinical record for Patient #1 did not include any documentation with the physician and they did not create a verbal order for the PT POC and frequencies. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he only collaborated with the physician if there were questions, and he faxed the OT POC to the physician for signature. 3. Patient #2’s clinical record evidenced a SOC on 9/25/24. An OT Evaluation was completed on 9/26/24 by OT 2 and a PT Evaluation was completed on 9/27/24 by PT 1. The record failed to include documentation with the physician and failed to include documentation of a verbal or written order for the OT and PT POC’s and frequency orders. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 verified the clinical record for Patient #2 did not include any documentation with the physician and they did not create a verbal order for the PT POC and frequencies. PT 2 relayed they faxed the PT POC to the physician a couple days after the evaluation visit. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he only collaborated with the physician if there were questions, and he faxed the OT POC to the physician for signature. 4. Patient #3’s clinical record evidenced a SOC on 4/23/24 and a recertification period of 8/21/24 to 10/19/24. OT and PT Evaluations were completed on 8/24/24 by OT 2 and PT 1. The record failed to include documentation with the physician and failed to include documentation of a verbal or written order for the OT and PT POC’s and frequency orders. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 verified the clinical record for Patient #3 did not include any documentation with the physician and they did not create a verbal order for the PT POC and frequencies. PT 2 relayed the PT recertification orders were faxed to the physician. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he there were no changes in Patient #3’s needs and he faxed the OT frequency order to the physician for signature. 5. Patient #4’s clinical record evidenced a SOC on 5/02/23 and a recertification period of 8/24/24 to 10/22/24. An OT Evaluation was completed on 8/17/24 by OT 2 and a PT Evaluation was completed on 8/21/24 by PT 1. The record failed to include documentation with the physician and failed to include documentation of a verbal or written order for the OT and PT POC’s and frequency orders. During an interview on 10/07/24 beginning at 2:04 PM, PT 1 verified the clinical record for Patient #4 did not include any documentation with the physician and they did not create a verbal order for the PT POC and frequencies. PT 2 relayed the PT recertification orders were faxed to the physician. During an interview on 10/07/24 beginning at 3:13 PM, OT 2 relayed he faxed the OT frequency order to the physician for signature. 6. Patient #6’s clinical record evidenced a SOC on 3/18/24 and a recertification period of 9/14/24 to 11/12/24. An OT Evaluation was completed on 9/07/24 by OT 2 and a PT Evaluation was completed on 9/14/24 by PT 1. The record failed to include documentation with the physician and failed to include documentation of a verbal or written order for the OT and PT POC’s and frequency orders. During an interview on 10/09/24 beginning at 10:36 AM, PT 1 relayed he thought he collaborated with the physician, however, the clinical record for Patient #6 did not include any documentation with the physician. PT 2 relayed the PT recertification orders were faxed to the physician. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed he did not collaborate with the physician for the recertification, and he faxed the OT frequency order to the physician for signature. 7. Patient #7’s clinical record evidenced a SOC on 3/18/24 and a recertification period of 9/14/24 to 11/12/24. An OT Evaluation was completed on 8/31/24 by OT 2. The record failed to include documentation with the physician and failed to include documentation of a verbal or written order for the OT frequency orders. During an interview on 10/09/24 beginning at 11:51 AM, OT 2 relayed he did not collaborate with the physician for the recertification, and he faxed the OT frequency order to the physician for signature. 410 IAC 17-14-1(a)(1)(G)

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the HHA was currently certified to provide home health services (See G754); failed to ensure the HHA provided services as ordered in the HHA POC (See G800) and failed to ensure the RN supervised the HHA every 14 days (See Tag G808). Findings include: The cumulative effect of these systemic problems had the potential to impact all 61 active patients which resulted in the agency being found out of compliance with the Condition of Participation 42 CFR 484.80 Home health aide services.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on personnel file review, policy review, and interview, the home health agency failed to ensure the HHA was currently certified to provide home health services for 1 of 1 HHA personnel file reviewed (HHA 1), which had the potential to affect 12 of 12 patients who received services during the time frame the aide was not certified (Patients #6, 7, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20). Findings include: 1. Agency policy “Competency Evaluation of Home Care Staff” indicated employees should be “licensed, registered, or certified as required by law, policy, or standards of practice.” 2. A list of current agency employees indicated HHA 1 was the only current HHA employed by the agency. 3. HHA 1’s personnel file indicated a hire date of 4/02/19. She was trained by the agency and issued a HHA certification by the State of Indiana on 6/04/19. The expiration date for the aide’s certification was 6/04/23. The file failed to evidence an active certification for HHA 1. 4. Review of the State of Indiana’s license and certification verification website, www.mylicense.IN.gov, on 10/09/24 evidenced the employee’s home health aide certification had expired on 6/04/23. The website failed to evidence HHA 1’s certification was renewed until 10/08/24. 5. A list of patients who received home health aide services from HHA 1 between 6/05/23 – 10/07/24 evidenced 12 patients received HHA services from the aide while she was not certified. These included Patients #6, 7, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20. 6. During an interview with HHA 1 on 10/09/24 beginning at 4:39 PM, she reported she was unaware her home health aide certification had expired on 6/04/23. 7. During an interview with Alternate Administrator on 10/09/24 beginning at 4:45 PM, she reported staff were responsible for ensuring their license and/or certification was kept up to date. 410 IAC 17-14-1(l)(1)(B)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the HHA provided services as ordered in the HHA POC for 5 of 5 patient records reviewed who have received HHA services for at least 2 weeks (Patient #6, 7, 11, 12 and 13). Findings include: 1. The undated policy “Home Health Aide Care Plan” indicated the HHA cannot be responsible for performing any procedure that is not assigned to him/her in writing or that is beyond his/her ability. 2. Patient #6’s clinical record for certification period 9/14/24 to 11/12/24 included a HHA care plan which indicated Patient #6 was to receive HHA visits 3 times a week. The aide care plan indicated the patient was to receive a shower/bath every visit. The HHA visit notes for 9/18/24, 9/25/24 and 10/02/24 failed to include Patient #6 receiving a shower/bath during the HHA visits. HHA 1 failed to document the reason for not bathing Patient # during the HHA visits. The HHA visit note for 10/03/24 indicated HHA 1 trimmed Patient #6’s hair. HHA 1 failed to document the reason for not bathing Patient #6 during the HHA visits and failed to follow the HHA care plan. During an interview on 10/09/24 beginning at 9:38 AM, HHA 1 relayed they are not a licensed beautician and shouldn’t have trimmed Patient #6’s hair and she relayed she only gives Patient #6 a shower on her assigned assisted living facility (ALF) shower days. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed the HHA should be documenting if a shower has not been given on the aide visit note and the HHA should not be cutting a patient’s hair when she is not licensed. 3. Patient #7’s clinical record for certification period 9/14/24 to 11/12/24 included a HHA care plan which indicated Patient #7 was to receive HHA visits 3 times a week. The aide care plan indicated the patient was to receive a shower/bath every visit. The HHA visit notes for 9/17/24, 9/18/24, 9/19/24, 9/24/24, 9/25/24, 9/26/24, 10/01/24, 10/02/24 and 10/03/24 failed to include Patient #7 receiving a shower/bath during the HHA visits. HHA 1 failed to document the reason for not bathing Patient #7 during the HHA visits. During an interview on 10/09/24 beginning at 9:38 AM, HHA 1 relayed Patient #7 prefers to bathe in the evening and the ALF staff give the patient the shower. 4. Patient #11’s clinical record for certification period 8/28/24 to 10/26/24 included a HHA care plan which indicated Patient #11 was to receive HHA visits 2 times a week. The HHA visit notes for 8/12/24, 8/16/24, 8/19/24, 8/23/24, 8/26/24, 8/30/24, 9/02/24, 9/06/24, 9/09/24, 9/16/24, 9/20/24, 9/23/24, 9/30/24 and 10/04/24 indicated HHA 1 took Patient #11 to the gym, park and shopping. HHA 1 failed to follow the aide care plan and HHA scope of practice. During an interview on 10/09/24 beginning at 9:38 AM, HHA 1 relayed Patient #11’s parents allow her to transport the patient to activities and to get snacks. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed they were unsure if transporting a patient was an allowable HHA activity. 5. Patient #12’s clinical record for certification period 8/16/24 to 10/14/24 included a HHA care plan which indicated Patient #12 was to receive HHA visits 3 times a week. The aide care plan indicated the patient was to receive a shower 1 time a week and partial bath the other visits of the week. The HHA visit notes for 8/13/24, 8/14/24, 8/15/24, 8/20/24, 8/21/24, 8/22/24, 8/27/24, 8/28/24, 8/29/24, 9/03/24, 9/04/24, 9/05/24, 9/10/24, 9/11/24, 9/12/24, 9/17/24, 9/18/24, 9/19/24, 9/24/24, 9/25/24, 9/26/24, 10/01/24, 10/02/24 and 10/03/24 failed to include Patient #12 receiving a shower/partial bath during the HHA visits. HHA 1 failed to document the reason for not bathing Patient #12 during the HHA visits. During an interview on 10/09/24 beginning at 9:38 AM, HHA 1 relayed Patient #12 prefers to bathe in the evening and the ALF staff give the patient the shower. 6. Patient #13’s clinical record for certification period 9/10/24 to 11/08/24 included a POC and aide care plan which indicated Patient #13 was to receive HHA visits 3 times a week. HHA visits were performed on 9/10/24, 9/11/24, 9/12/24, 9/17/24, 9/18/24, 9/19/24, 9/24/24, 9/25/24, 9/26/24, 10/01/24, 10/02/24 and 10/05/24. The POC for certification period 9/10/24 to 11/08/24 failed to include orders for HHA visits. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed the HHA frequencies should have been listed on the POC. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed the HHA frequencies should be on the POC and she was unsure why they were missing. 7. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed the HHA should be documenting if the HHA is offering the shower and the reason it was not given.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the RN supervised the HHA every 14 days for 2 of 2 active clinical records reviewed of patients receiving skilled services and HHA services (Patient #6 and 7). Findings include: 1. The undated agency policy “Home Health Aide Supervision” indicated when skilled services are being provided to a patient, a RN/Therapist must make a supervisory visit to the patient’s residence at least every fourteen (14) days to assess relationships and determine whether goals are being met. 2. Patient #6’s clinical record included a POC for the certification period 9/14/24 to 11/12/24 and included orders for SN, PT, OT and HHA services. The record evidenced the RN performed HHA supervisory visits on 7/11/24 and 9/09/24. The clinical record failed to evidence RN 1 performed HHA supervisory visits every 14 days. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed HHA supervisory visits should be done every 30 days. When queued, she stated she did not perform HHA supervisory visits for Patient #6 every 14 days. 3. Patient #7’s clinical record included a POC for the certification period 9/14/24 to 11/12/24 and included orders for SN, OT and HHA services. The record evidenced the RN performed HHA supervisory visits on 7/11/24 and 9/09/24. The clinical record failed to evidence RN 1 performed HHA supervisory visits every 14 days. During an interview on 10/09/24 beginning at 10:12 AM, RN 1 relayed HHA supervisory visits should be done every 30 days. When queued, she stated she did not perform HHA supervisory visits for Patient #7 every 14 days. 4. During an interview on 10/09/24 beginning at 9:50 AM, the Alternate Administrator relayed supervisory visits should be done every 30 days. 410 IAC 17-14-1(h)

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Administrator was managing the day-to-day operations of the agency (see G948); failed to ensure a clinical manager was available during operating hours (See G950); failed to ensure the Clinical Manager was involved in daily activities of the agency (See G958); and failed to ensure the Clinical Manager was involved in the operations / oversight of the home health agency (See Findings below). Findings include: 1. The undated agency policy “Clinical Supervision” indicated the Director of Nursing/Nursing Supervisor shall be responsible for the quality of care provided and supervision of all staff providing therapeutic services. He/she will also be responsible for organizing and directing the Agency’s ongoing functions and nursing leaders shall coordinate the day-to-day operation of the organization and work with the Administrator. 2. The undated agency policy “Governing Body” indicated the duties and responsibilities of the Governing Body shall include adopting and periodically reviewing and approving administrative and personnel policies, patient care policies and procedures, bylaws as required, the annual operating budget and capital expenditure plan; overseeing the management and fiscal affairs of the agency, this shall include organizational operations; define the corporate structure and clearly indicate lines of authority. This policy indicated Heather Myers was appointed as the Administrator and Director of Nursing on 11/09/08. 3. Review of the home health agency organizational chart evidenced Admin 3 as the Clinical Manager of the agency. 4. Review of CMS provider details, last updated on 4/27/23, evidenced Admin 3 as the Clinical Manager of the agency. 5. Review of the Governing Body minutes, dated 12/15/23, failed to evidence Admin 3 was appointed as the Clinical Manager effective 4/07/23. 6. During an interview on 10/08/24 beginning at 8:23 AM, Admin 3 (who is listed as the Clinical Manager) relayed she was only available as a consultant. She also relayed she was unsure who the current clinical staff were at this time as she was not involved in the daily activities of the agency. She also relayed that she tried to check in with the agency at least once a year and has not provided any consulting services to the agency in over a year. Admin 3 stated Admin 2 was the Administrator and Clinical Manager of the home health agency. 7. During an interview on 10/09/24 beginning at 5:06 PM, Admin 1 (who is listed as the Administrator of the agency) relayed she was the only member of the Governing Body and Admin 2 was the current Administrator and Clinical Manager of the agency and Admin 2 was responsible for the day-to-day activities and overseeing patient care. 8. The cumulative effect of these problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR 484.105 Organization and Administration of Services.

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 agency failed to ensure the Administrator was responsible for the day-to-day operations of the agency for 1 of 1 agency. Findings include: 1. During the entrance conference on 10/03/24 beginning at 9:58 AM, the Alternate Administrator listed Admin 1 as the Administrator of the home health agency. Review of the form CMS 1572, completed by the Alternate Administrator on 10/04/24 evidenced Admin 1 listed as the Administrator. The home health agency failed to have an Administrator that was responsible for the day-to-day operations of the agency. 2. During an interview on 10/04/24 beginning at 3:48 PM, COTA 1 relayed Admin 1 was the Administrator of the agency. 3. During an interview on 10/08/24 beginning at 8:23 AM, Admin 3 (who is listed as the Clinical Manager) relayed she thought Admin 2 was the Administrator of the agency. 4. During an interview on 10/09/24 beginning at 5:06 PM, Admin 1 (who is listed as the Administrator of the agency) relayed Admin 2 was the current Administrator of the agency. 410 IAC 17-12-1(c)(1)

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on record review and interview the Administrator failed to ensure a clinical manager was available during operating hours for 1 of 1 home health agency surveyed. Findings include: 1. During the entrance conference on 10/03/24 beginning at 9:58 AM, the Alternate Administrator listed Admin 3 as the Clinical Manager of the home health agency. Review of CMS provider details, last updated on 4/27/23, evidenced Admin 3 as the Clinical Manager of the agency. Review of the home health agency organizational chart evidenced Admin 3 as the Clinical Manager of the agency. 2. During an interview on 10/07/24 beginning at 12:58 PM, RN 1 relayed they were unsure when the Clinical Manager (Admin 3) was available. 3. During an interview on 10/08/24 beginning at 8:23 AM, Admin 3 (who is listed as the Clinical Manager) relayed she was only available as a consultant, and she thought Admin 2 was the Clinical Manager of the agency. 4. During an interview on 10/09/24 beginning at 5:06 PM, Admin 1 (who is listed as the Administrator of the agency) relayed Admin 2 was the current Clinical Manager of the agency. 410 IAC 17-12-1(d)

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure the Clinical Manager was involved in daily activities of the agency for 1 of 1 home health agency surveyed. Findings include: 1. During the entrance conference on 10/03/24 beginning at 9:58 AM, the Alternate Administrator listed Admin 3 as the Clinical Manager of the home health agency. Review of CMS provider details, last updated on 4/27/23, evidenced Admin 3 as the Clinical Manager of the agency. Review of the home health agency organizational chart evidenced Admin 3 as the Clinical Manager of the agency. 2. During an interview on 10/08/24 beginning at 8:23 AM, Admin 3 (who is listed as the Clinical Manager) relayed she was only available as a consultant, and she thought Admin 2 was the Clinical Manager of the agency. She also relayed she was unsure who the current clinical staff were at this time as she was not involved in the daily activities of the agency. 4. During an interview on 10/09/24 beginning at 5:06 PM, Admin 1 (who is listed as the Administrator of the agency) relayed Admin 2 was the current Clinical Manager of the agency and was responsible for the day-to-day activities. 410 IAC 17-12-1(d)

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: See Tag G940

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: See Tag G940

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: See Tag G940

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: See Tag G940

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: See Tag G940

Contact info for primary care practitioner CFR(s): 484.110(a)(5) Contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA; and This ELEMENT is not met as evidenced by: Based upon record review and interview, the home health agency failed to ensure the accuracy of the correct attending physician for 2 of 11 records reviewed (Patient #5 and 11). Findings include: 1. Patient #5’s clinical record included a POC for the certification period of 9/03/24 to 11/01/24 which indicated the patient’s attending physician was Physician L. Physician L’s name was marked through on the POC and Physician P signed the POC. During an interview on 10/07/24 beginning at 12:55 PM, RN 1 relayed she was unsure why the POC had Physician L listed as the attending physician. 2. Patient #11’s clinical record included a POC for the certification period of 8/28/24 to 10/26/24 which indicated the patient’s attending physician was Physician L. Physician L’s name was marked through on the POC and the POC was signed by another practitioner (unable to read). During an interview on 10/07/24 beginning at 12:55 PM, RN 1 relayed she was unsure why the POC had Physician L listed as the attending physician. She relayed the POC was faxed to Physician P for approval. 3. A telephone call was placed to Physician P's office on 10/07/24 at 11:55 AM to attempt to verify the attending physician for Patient #5 and 11 with no return call received. 4. During an interview on 10/08/24 beginning at 12:12 PM, the Alternate Administrator was unsure why the electronic medical record (EMR) system was pulling Physician L’s name to the POC’s. She relayed she would contact the EMR system to inquire about this. 410 IAC 17-15-1(a)(2)

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR S 484.22. Survey Dates: October 19, 20, 21, 22, 25; 2021 Facility Number: 012094 Provider ID: 157610 Active Census: 72 At this Emergency Preparedness survey, Home Health Angels was found not in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR S 484.22

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain an Emergency Preparedness Plan (EPP) training program which trained staff on the plan every 2 years and kept documentation of the training, which had the potential to affect all patients and employees. 1. An undated agency policy titled “Emergency Care Policy” indicated but was not limited to “… Staff will be informed of emergency procedures during orientation, with any changes or updates to the process, and reviewed annually … Emergency Plan … All staff shall receive emergency preparedness training appropriate for their position at hire, with any updates and changes, and on a yearly basis ….” 2. The agency’s Emergency Preparedness binder was reviewed on 10/25/21. The binder failed to evidence documentation of emergency preparedness training performed after 2017. 3. The personnel file of the Administrator was reviewed on 10/25/21. The file failed to evidence documentation of emergency preparedness training performed after 2017. 4. The personnel file of the Clinical Manager was reviewed on 10/25/21. The file failed to evidence documentation of emergency preparedness training performed after 2017. 5. The personnel file of the Alternate Administrator was reviewed on 10/25/21. The file failed to evidence documentation of emergency preparedness training performed after 2017. 6. The personnel file of Physical Therapy Assistant (PTA #1) was reviewed on 10/25/21. The file failed to evidence documentation of emergency preparedness training performed after 2017. 7. The personnel file of Social Worker (MSW #1) was reviewed on 10/25/21. The file failed to evidence documentation of emergency preparedness training performed after 2017. 8. An interview was conducted on 10/25/21 at 5:22 PM with the Administrator, Clinical Manager, Alternate Administrator, and Administrative Assistant #1. During the interview, the Administrator confirmed emergency preparedness training should be conducted at least every two years. The Administrator also confirmed the agency had not conducted emergency preparedness training of all staff since 2017.

This was a Federal recertification, State re-licensure survey, and COVID-19 focused infection control survey of a Home Health Agency. The survey was announced as fully extended on 10/25/21 at 4:07 PM. Survey Dates: October 19, 20, 21, 22, 25; 2021 Facility Number: 012094 Provider ID: 157610 Unduplicated Admissions for Past 12 Months: 194 Active Census: 72 These deficiencies reflect State Findings cited in accordance with 410 IAC 17.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the discharge summary included the patient’s progress towards their goals for 2 of 2 discharge records reviewed (#6, 7). 1. An undated agency policy titled “Discharge Summary” indicated but was not limited to “… Special Instructions: 1. When a patient is discharged from the agency, the supervising professional shall complete a Discharge Summary form … 3. The Registered Nurse [RN]/Therapist will assure that the treatment goals and patient outcomes have been met ….” 2. The clinical record of Patient #6 was reviewed on 10/22/21 and indicated a discharge date of 6/4/21 for the reason of “patient/family request. Patient transferring to hospice care.” The record included a Discharge Assessment completed on 6/4/21 by RN #2. The discharge summary failed to evidence Patient #6’s progress towards their goals. 3. The clinical record of Patient #7 was reviewed on 10/22/21 and indicated a discharge date of 8/6/21 for the reason of “patient transferring to hospice care.” The record included a Discharge Assessment completed on 8/6/21 by RN #2. The discharge summary failed to evidence Patient #6’s progress towards their goals. 4. An interview was conducted on 10/22/21 at 3:05 PM with the Administrator, Clinical Manager, Alternate Administrator, and Administrative Assistant #1. During the interview, the Clinical Manager confirmed the discharge summary should include the patient’s progress towards their goals.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a discharge summary was sent to the receiving agency for 2 of 2 discharge records of patients transferred to another agency (#6, 7). 1. An undated agency policy titled “Discharge Summary” indicated but was not limited to “… Special Instructions: 1. When a patient is discharged from the agency, the supervising professional shall complete a Discharge Summary form … 4. If the patient is being referred to another agency or facility, a Transfer Summary form shall also be completed ….” 2. The clinical record of Patient #6 was reviewed on 10/22/21 and indicated a discharge date of 6/4/21 for the reason of “patient/family request. Patient transferring to hospice care.” The record included a Discharge Assessment completed on 6/4/21 by RN #2. The record failed to evidence the discharge summary was sent to the receiving hospice agency. 3. The clinical record of Patient #7 was reviewed on 10/22/21 and indicated a discharge date of 8/6/21 for the reason of “patient transferring to hospice care.” The record included a Discharge Assessment completed on 8/6/21 by RN #2. The record failed to evidence the discharge summary was sent to the receiving hospice agency. 4. An interview was conducted on 10/22/21 at 3:05 PM with the Administrator, Clinical Manager, Alternate Administrator, and Administrative Assistant #1. During the interview, the Clinical Manager confirmed the agency did not send a discharge or transfer summary to the receiving agency. The Clinical Manager also confirmed a “verbal communication … report” was given to the receiving agency when a patient was discharged or transferred to another agency.

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 home health agency failed to ensure the plan of care (POC) included the patient’s mental, psychosocial, and cognitive status; all supplies and equipment required; duration of visits to be made; activities permitted, all medications and treatments, all safety measures to protect against injury; necessary interventions related to the patient’s risks for ED visits and hospital readmission; patient specific, detailed, and measurable goals; advance directives information, and any additional items, for 5 of 5 active records reviewed (#1, 2, 3, 4, 5). 1. An undated agency policy titled “Plan of Care” indicated but was not limited to “… Special Instructions … 2. The individualized plan of care must include the following: … The patient’s mental, psychosocial, and cognitive skills … The types of … supplies, and equipment required … duration of visits to be made … Activities Permitted … All medications and treatments … Safety measures to protect against injury … 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 … Patient and caregiver education and training to facilitate timely discharge … measurable outcomes and goals … Information related to any advanced directives … Any additional items ….” 2. Chippewa Valley Technical College (no date). Nursing Skills. Retrieved 10/27/21 from https://wtcs.pressbooks.pub/nursingskills/. “… Enteral Tube Management … nurses perform additional interventions to prevent aspiration. The American Association of Critical‐Care Nurses recommends the following guidelines to reduce the risk for aspiration: … Assess feeding tube placement … Assess for gastrointestinal intolerance … Measurement of gastric residual volume (GRV) [measurement of enteral feeding remaining in stomach] is performed by using a 60-mL syringe to aspirate stomach contents through the tube. It has traditionally been used to assess aspiration risk ….” 3. The clinical record of Patient #1 was reviewed on 10/20/2021 and indicated a start of care date of 9/14/21 with patient diagnoses including but not limited to presence of a G-tube (medical tube inserted into the stomach to assist with nutrition), adult failure to thrive, dysphagia (difficulty swallowing), and urinary tract infections. The record included a plan of care for the certification period 9/14/21 – 11/12/21. The POC’s service orders indicated the patient was to receive skilled nursing visits, 1 visit per week for 9 weeks and physical therapy (PT) and occupational therapy (OT) were to evaluate and treat. The record included an update to the plan of care, dated 9/22/21, which indicated the patient was to receive physical therapy services, 1 visit per week for 1 week then 2 visits per week for 4 weeks. The plan of care failed to evidence the duration of visits to be provided. A home visit observation was conducted on 10/19/21at 1:27 PM with Patient #1 and Registered Nurse (RN) #1. During the visit, RN #1 confirmed Patient #1 had severe depression and Family Member #1 confirmed the patient still exhibited depression symptoms. Family Member #1 also confirmed Patient #1 was recently hospitalized for an “almost fall,” but the patient did not actually fall because the family member caught him prior to the patient hitting the floor. Patient #1 was observed with a G-tube present in his left upper abdomen, and RN #1 and Family Member #1 discussed the patient’s orders for enteral (administered directly into the stomach) nutrition administration. A pole, pump for enteral nutrition administration, and enteral administration tubing was observed to be present in the patient’s home. The POC failed to evidence the patient’s depression within the “Mental Status” section, failed to evidence the patient’s increased risk for falls within the “Safety Measures” section, failed to evidence the IV pole, feeding pump, and feeding tubing within the “DME [Durable Medical Equipment] and Supplies” section, and failed to evidence orders for frequency of assessing and call parameters for gastric residual volume. The POC included a section titled “Patient risk for Hospital and ER,” which evidenced the patient had multiple risk factors for hospitalization and ER visits. The section indicated but was not limited to “… Risk for hospitalization added to POC with appropriate interventions: Yes.” The POC failed to evidence the specific interventions the agency was to enact to reduce the patient’s risk factors for hospitalization and ER visits. The POC included a section titled “Goals/Rehabilitation Potential/Discharge Plans,” which indicated but was not limited to “… Goals: … Caregiver/Patient will be able to do G-tube feedings, flushes, and care. Patient will know [signs and symptoms] to report to MD ….” The POC failed to evidence patient-specific, detailed, and measurable goals. The POC included a section titled “Advance Directives” which was left blank. The POC failed to evidence the presence or absence of any advance directives. 4. The clinical record of Patient #2 was reviewed on 10/20/21 and indicated a start of care date of 7/15/21 with patient diagnoses including but not limited to myelodysplastic syndrome (group of blood cell production disorders), high blood pressure, and generalized muscle weakness. The record included a plan of care for the certification period 9/13/21 – 11/11/21 and a recertification comprehensive assessment completed on 9/10/21 by RN #1. The assessment indicated but was not limited to “… 60 Day Summary: Patient is alert and oriented with episodes of forgetfulness ….” The POC failed to evidence the patient’s forgetfulness within the “Mental Status” section. The POC’s service orders indicated the patient was to receive skilled nursing visits, 1 visit per week for 9 weeks, and physical therapy and occupational therapy were to evaluate and treat the patient. The record included an update to the plan of care, dated 9/13/21, which indicated the patient was to receive PT services, 2 visits per week for 4 weeks, and OT services, 2 visits per week for 3 weeks. A second update to the POC, dated 9/30/21, indicated the patient was to continue to receive OT services, 2 visits per week for 3 weeks. A third update to the POC, dated 10/9/21, indicated the patient was to continue to receive PT services, 2 visits per week for 4 weeks. The plan of care failed to evidence the duration of visits to be provided. The POC’s medication list indicated the patient was to receive Oxygen, 2 liters per minute at bedtime via “inhalation.” The POC failed to evidence the specific route of administration for the oxygen (nasal cannula, mask, etc). The POC included a section titled “Patient risk for Hospital and ER,” which evidenced the patient had multiple risk factors for hospitalization and ER visits. The section indicated but was not limited to “… Risk for hospitalization added to POC with appropriate interventions: Yes.” The POC failed to evidence the specific interventions the agency was to enact to reduce the patient’s risk factors for hospitalization and ER visits. The POC included a section titled “Goals/Rehabilitation Potential/Discharge Plans” which indicated but was not limited to “… Patient will safely perform ADLs and light IADLs with stable vital signs, with reduce[d] shortness of breath at modified independent level ….” The POC failed to evidence all goals were patient specific and measurable. The POC included a section titled “Advance Directives” which was left blank. The POC failed to evidence the presence or absence of any advance directives. 5. The clinical record of Patient #3 was reviewed on 10/20/21 and indicated a start of care date of 2/26/18 with patient diagnoses including but not limited to multiple sclerosis, hyperglycemia [high blood sugar], and urine retention. The record included a plan of care for the recertification period 10/8/21 – 12/6/21. A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 (start of care 2/26/18) and Home Health Aide (HHA) #1. During the visit, Family Member #2 confirmed the patient was being treated for depression and the patient had a Hoyer lift however the patient did not use this equipment due to inability to maneuver it and the patient being “scared” of the lift. Family Member #2 also confirmed the patient was bed bound other than leaving the home for doctor appointments, and the family member would transfer the patient from the bed to the wheelchair by himself. During the visit urostomy supplies, a hospital bed, and IV infusion supplies were observed within the home. The POC failed to evidence the patient’s depression within the “Mental Status” section, failed to evidence all equipment and supplies within the “DME and Supplies” section, and failed to evidence a more detailed and patient-specific “Activities Permitted” section. The POC included service orders for 3 skilled nursing visits “as needed” and home health aide (HHA) visits, 1 visit per week for 1 week, 5 visits per week for 8 weeks, then 1 visits per week for 1 week. The POC also included the HHA service orders for 4 visits per week for “4 hours a day. Hours may fluctuate due to Dr. appointments.” The POC failed to evidence clear orders for HHA services. The POC included the medication orders for acetaminophen-hydrocodone (Norco, opioid medication given to treat pain) 325 milligrams (mg)-5 mg twice a day “PRN” (as needed) by mouth; nystatin (given to treat fungal infections) 100,000 units/gram twice a day PRN on the skin; and Solumedrol (antibiotic given to treat bacterial infections) “1 [gram] monthly IV.” The POC failed to evidence indications for administration for as needed medications and failed to evidence specific administration directions (administration rate, length of administration, etc). The POC included a section titled “Patient risk for Hospital and ER,” which evidenced the patient had multiple risk factors for hospitalization and ER visits. The section indicated but was not limited to “… Risk for hospitalization added to POC with appropriate interventions: Yes.” The POC failed to evidence the specific interventions the agency was to enact to reduce the patient’s risk factors for hospitalization and ER visits. The POC included a section titled “Goals/Rehabilitation Potential/Discharge Plans” which indicated but was not limited to “Pt [Patient] to remain clean, neat and odor free t/o [throughout] this cert period. Pt safety, nutrition, hydration, needs will be met t/o this cert period.” The POC failed to evidence patient-specific, detailed, and measurable goals. The POC included a section titled “Advance Directives” which was left blank. The POC failed to evidence the presence or absence of any advance directives. 6. The clinical record of Patient #4 was reviewed on 10/21/21 and indicated a start of care date 10/8/21 with patient diagnoses including but not limited to right hip fracture, COVID-19, pressure ulcers, cognitive communication deficit, and Type 2 Diabetes. The record included an initial plan of care for the certification period 10/8/21 – 12/6/21. The POC included service orders for skilled nursing, 1 visit per week for 1 week, 2 visits per week for 2 weeks, 1 visit per week for 6 weeks, and 1 visit per week for 1 week; physical therapy to evaluate and treat, and occupational therapy to evaluate and treat. The POC was updated on 10/12/21 with PT service visit orders for 1 visit per week for 1 week, 2 visits per week for 3 weeks. The POC failed to evidence the duration of visits to be conducted. The POC included a section titled “Patient risk for Hospital and ER,” which evidenced the patient had multiple risk factors for hospitalization and ER visits. The section indicated but was not limited to “… Risk for hospitalization added to POC with appropriate interventions: Yes.” The POC failed to evidence the specific interventions the agency was to enact to reduce the patient’s risk factors for hospitalization and ER visits. The POC included a section titled “Advance Directives” which was left blank. The POC failed to evidence the presence or absence of any advance directives. 7. The clinical record of Patient #5 was reviewed on 10/21/21 and indicated a start of care 10/8/21 with the patient diagnoses including but not limited to left knee replacement, left knee osteoarthritis, and high blood pressure. The record included an initial plan of care for the certification period 10/8/21 – 12/6/21. The POC included service orders for skilled nursing for 1 visit per week for 5 weeks and physical therapy to evaluate and treat. The POC was updated on 10/11/21 with PT service orders for 3 visits per week for 1 week then 2 visits per week for 2 weeks. The POC included a section titled “Patient risk for Hospital and ER,” which evidenced the patient had multiple risk factors for hospitalization and ER visits. The section indicated but was not limited to “… Risk for hospitalization added to POC with appropriate interventions: Yes.” The POC failed to evidence the specific interventions the agency was to enact to reduce the patient’s risk factors for hospitalization and ER visits. The POC included a section titled “Goals/Rehabilitation Potential/Discharge Plans” which indicated but was not limited to “… PT/INR [blood test used to check the time it takes for a patient’s blood to clot] will be in therapeutic range t/o this cert period. Left knee incision will show signs of healing t/o this cert period.” The POC failed to evidence patient specific, detailed, and measurable goals. The POC included a section titled “Advance Directives” which was left blank. The POC failed to evidence the presence or absence of any advance directives. 8. An interview was conducted on 10/22/21 at 3:05 PM with the Administrator, Clinical Manager, Alternate Administrator, and Administrative Assistant #1. During the interview, the Clinical Manager confirmed the plan of care should include supplies and equipment required and advance directive information. The Administrator confirmed the plan of care should include the patient’s mental, psychosocial, and cognitive status; duration of visits to be made, all medications and treatments, safety measures to protect against injury, interventions for the patient’s risk factors for hospitalization and ED visits, and patient-specific and measurable goals. 17-13-1(a)(1)(C)(i, ii, iii, vii, ix, x, xiii)

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide the patient with a written schedule of visits for 3 of 3 home visit observations (#1, 2, 3). 1. An undated agency job description titled “Administrator Job Description” indicated but was not limited to “… 4. Develops policies and procedures to ensure compliance with federal and state laws and regulations … Client Care Duties … 7. Uphold all applicable state regulations and guidelines as set forth in Indiana Administrative Code and by the Indiana State Department of Health.” 2. A home visit observation was conducted on 10/19/21 at 1:27 PM with Patient #1 (start of care 9/14/21) and Registered Nurse (RN) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence a written schedule of visits was provided to the patient. An interview of Family Member #1 was conducted on 10/19/21 at 1:55 PM. During the visit, Family Member #1 confirmed the agency did not provide a written schedule of visits. 3. A home visit observation was conducted on 10/19/21 at 2:32 PM with Patient #2 (start of care 7/15/21) and Certified Occupation Therapist Assistant (COTA) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence a written schedule of visits was provided to the patient. A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 (start of care 2/26/18) and Home Health Aide (HHA) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence a written schedule of visits was provided to the patient. 4. An interview was conducted on 10/20/21 at 1:30 PM with the Administrator, Clinical Manager, and Administrative Assistant #1. During the interview, the Administrator confirmed the agency did not provide a written copy of a visit schedule to all patients. The Administrator also indicated the home binder included blank calendar pages in case the patients “wanted” to fill them out.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide the patient with a written plan of care (POC) for 3 of 3 home visit observations (#1, 2, 3). 1. An undated agency job description titled “Administrator Job Description” indicated but was not limited to “… 4. Develops policies and procedures to ensure compliance with federal and state laws and regulations … Client Care Duties … 7. Uphold all applicable state regulations and guidelines as set forth in Indiana Administrative Code and by the Indiana State Department of Health.” 2. A home visit observation was conducted on 10/19/21 at 1:27 PM with Patient #1 (start of care 9/14/21) and Registered Nurse (RN) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence the patient’s plan of care. 3. A home visit observation was conducted on 10/19/21 at 2:32 PM with Patient #2 (start of care 7/15/21) and Certified Occupation Therapist Assistant (COTA) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence the patient’s plan of care. 4. A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 (start of care 2/26/18) and Home Health Aide (HHA) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence the patient’s plan of care. 5. An interview was conducted on 10/20/21 at 1:30 PM with the Administrator, Clinical Manager, and Administrative Assistant #1. During the interview, the Administrator confirmed the agency did not provide a written copy of the plan of care to the patient.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide the clinical manager’s name and contact information in writing to patients for 3 of 3 home visit observations (#1, 2, 3). 1. An undated agency job description titled “Administrator Job Description” indicated but was not limited to “… 4. Develops policies and procedures to ensure compliance with federal and state laws and regulations … Client Care Duties … 7. Uphold all applicable state regulations and guidelines as set forth in Indiana Administrative Code and by the Indiana State Department of Health.” 2. An agency sample home binder was reviewed on 10/19/21 at 11:40 AM. The sample home binder failed to evidence the name and contact information for the clinical manager. 3. A home visit observation was conducted on 10/19/21 at 1:27 PM with Patient #1 (start of care 9/14/21) and Registered Nurse (RN) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence the clinical manager’s name and contact information. 4. A home visit observation was conducted on 10/19/21 at 2:32 PM with Patient #2 (start of care 7/15/21) and Certified Occupation Therapist Assistant (COTA) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence the clinical manager’s name and contact information. 5. A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 (start of care 2/26/18) and Home Health Aide (HHA) #1. During the visit, the patient’s home health agency binder was observed and reviewed. The home binder failed to evidence the clinical manager’s name and contact information. 6. An interview was conducted on 10/20/21 at 1:30 PM with the Administrator, Clinical Manager, and Administrative Assistant #1. During the interview, the Administrator confirmed the home binder did not include the clinical manager’s name and contact information.

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 home health agency failed to ensure all staff followed standard precautions and agency infection control policies and procedures related to hand hygiene and bag technique for 3 of 3 home visit observations (#1, 2, 3). 1. An undated agency policy titled “Handwashing/Hand Hygiene” indicated but was not limited to “… Special Instructions: … Indications for hand washing and hand antisepsis: … d. Between tasks on the same patient … f. After removing gloves … Hand Hygiene Technique. 1. When decontaminating hands with an alcohol based hand rub, apply product to palm of one hand and rub hands together, covering all surfaces of hands and fingers, until hands are dry ….” 2. The Association for Biosafety and Biosecurity (5/4/2020). “COVID-19 FAQs PPE Use.” Retrieved 10/19/21 from www.absa.org. “… 1. Can disposable gloves be reused? … Per the OSHA Bloodborne Pathogen Standard, disposable gloves cannot be reused … Gloves should be changed frequently during the day, even if not visibly contaminated … 2. Can disposable gloves be disinfected safely? Chemicals like alcohol (hand sanitizer) … can affect the porosity of gloves, causing them to become more porous and/or sticky … CDC does not recommend disinfection of disposable medical gloves as standard practice. This practice is inconsistent with general disposable glove usage, but, in times of extreme disposable medical glove shortages, the option may need to be considered ….” 3. McGoldrick (3/2009). "Cleaning and Disinfection of Patient Care Equipment used in the Home Setting." Retrieved 11/5/21 from www.cdss.ca.gov " … Disinfection of Patient Care Equipment … vital sign equipment and supplies be cleaned with a low- or intermediate-level disinfectant in the home after use and prior to placing the equipment back in the nursing back for use on another patient … Disinfectant Contact Time. Contact time is the amount of time that the item or surface is to be kept 'wet' with the disinfectant up through complete drying of the disinfectant on the surface … Most EPA-registered hospital disinfectants have a label contact time of 10 minutes … staff member must follow the safety precautions and use directions on the labeling of each registered product. If they do not follow the specified … contact time … the practice is considered a misuse of the product …." 4. A home visit observation was conducted on 10/19/21 at 1:27 PM with Patient #1 (start of care 9/14/21) and Registered Nurse (RN) #1. During the visit, RN #1 wore the same pair of gloves through the entire visit, and applied alcohol based hand sanitizer (ABHS) directly on to the gloves five separate instances. RN #1 also removed her cell phone from her shirt pocket during the visit, performed a calculation on it, then placed the phone into the nursing bag. The nurse failed to perform hand hygiene according to agency procedure and best practice, and failed to clean used items prior to placing them back into the nursing bag. 5. A home visit observation was conducted on 10/19/21 at 2:32 PM with Patient #2 (start of care 7/15/21) and Certified Occupation Therapist Assistant (COTA) #1. During the visit, COTA #1 obtained the patient’s vital signs with a reusable thermometer, blood pressure monitor, and oxygen saturation probe, wiped the vital sign equipment with alcohol wipes, then placed the equipment immediately back into her bag. While wiping the equipment, the occupational therapy assistant was observed placing the used wipes on a clean drape. At the end of the visit, COTA #1 failed to perform hand hygiene after removing her gloves. 6. A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 (start of care 2/26/18) and Home Health Aide (HHA) #1. During the visit, HHA #1 waved her hands in the air after applying ABHS. The aide also failed to remove her gloves and perform hand hygiene after emptying the patient’s suprapubic catheter. 7. An interview was conducted on 10/20/21 at 1:30 PM with the Administrator, Clinical Manager, and Administrative Assistant #1. During the interview, the Clinical Manager confirmed staff should wipe equipment and allow the alcohol to dry according to manufacturer’s instructions prior to returning the equipment to the nursing bag, should not wave hands in the air when performing hand hygiene with ABHS, and should remove gloves and perform hand hygiene after handling a urinary catheter and urine. The Administrator confirmed the agency did not have any current shortages of gloves or other personal protective equipment. 17-12-1(m)

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 observation, record review, and interview, the Registered Nurse (RN) failed to conduct a through and complete nursing assessment for 1 of 1 home visit observations of a skilled nurse visit (#1). An undated agency job description titled “Position: Registered Nurse” indicated but was not limited to “… Essential Functions/Areas of Accountability … 2. Consistently demonstrates competency with technical nursing skills … a. Assessment skills ….” Chippewa Valley Technical College (no date). Nursing Skills. Retrieved 10/27/21 from https://wtcs.pressbooks.pub/nursingskills/. “… Enteral Tube Management … nurses perform additional interventions to prevent aspiration. The American Association of Critical‐Care Nurses recommends the following guidelines to reduce the risk for aspiration: … Assess feeding tube placement … Assess for gastrointestinal intolerance … Measurement of gastric residual volume (GRV) [measurement of enteral feeding remaining in stomach] is performed by using a 60-mL syringe to aspirate stomach contents through the tube. It has traditionally been used to assess aspiration risk ….” The clinical record of Patient #1 was reviewed on 10/20/2021 and indicated a start of care date of 9/14/21 with patient diagnoses including but not limited to presence of a G-tube (medical tube inserted into the stomach to assist with nutrition), adult failure to thrive, dysphagia (difficulty swallowing), and urinary tract infections. The record included a plan of care for the certification period 9/14/21 – 11/12/21. The POC’s service orders indicated the patient was to receive skilled nursing visits, 1 visit per week for 9 weeks, for “skilled nursing assessment … Assess/monitor … nutrition and hydration. Instruct [patient and/or caregiver] on G-tube care, feedings and flushes ….” A home visit observation was conducted on 10/19/21 at 1:27 PM with Patient #1 and Registered Nurse (RN) #1. During the visit, Patient #1 was observed to have a G-tube (medical tube inserted into the stomach to assist with nutrition) present in the left upper abdomen. RN #1 failed to assess the patient’s gastric residual volume directly or discuss with Family Member #1 if GRV was being assessed. An interview was conducted on 10/20/21 with the Administrator, Clinical Manager, and Administrative Assistant #1. During the interview, the Clinical Manager and Administrator confirmed the agency did not expect nurses to assess for gastric residual volume unless ordered by the patient’s provider.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the home health aide (HHA) care plan was detailed, patient specific, and followed the agency’s policy for 1 of 1 records of patients receiving HHA services (#3). An undated agency policy titled “Home Health Aide Care Plan” indicated but was not limited to: “Policy: A complete and appropriate Care Plan, identifying duties to be performed by the Home Health Aide, shall be developed by a Registered Nurse or Therapist … Special Instructions: 1. Following the initial nursing assessment and consultation with the patient/caregiver, a written plan identifying personal care and supportive care services are prepared … 2. The Care Plan shall be developed in plain, non-technical lay terms and identify the duties to be performed ….” The clinical record of Patient #3 was reviewed on 10/20/21 and indicated a start of care date of 2/26/18 with patient diagnoses including but not limited to multiple sclerosis, hyperglycemia [high blood sugar], and urine retention. The record included a plan of care (POC) for the recertification period 10/8/21 – 12/6/21, which indicated the patient was to receive skilled nursing (SN) and home health aide services. The POC indicated the aide tasks were to include “… assist with ADLs, bathing, meal prep, meal set up, light housekeeping, monitor for choking or s/s [signs and/or symptoms] of infection. HHA to report any concerns to SN … [Patient #3] is mostly bedfast and requires around the clock care. She is dependent for any transfers. HHA to monitor skin for any breakdown and report any wounds to SN ….” A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 and Home Health Aide #1. During the visit, HHA #1 was observed emptying the patient's urostomy. The aide confirmed she would change the patient's urostomy bag twice a week on Tuesdays and Thursdays. The clinical record included an “Aide Care Plan” documented and signed by RN #2 on 10/11/21. The care plan indicated but was not limited to “… Precautionary and Other Pertinent Information … Watch for hyper/hypoglycemia [high and low blood sugar] … Assignment: … Bed Bath – Partial/Complete … Ostomy Care ….” The care plan failed to follow the agency’s policy by including non – technical lay terms (hyper/hypoglycemia); failed to be patient specific and detailed by failing to evidence the specific signs and symptoms of hyperglycemia and hypoglycemia to report, failing to evidence whether the aide was to perform a partial or complete bath, failing to evidence specific care to be performed to the patient’s urostomy (emptying bag, changing pouch, specific signs and symptoms to report, etc); and failed to include all tasks included in the POC by failing to evidence the tasks for monitoring for chocking and signs and symptoms of infection. An interview was conducted on 10/22/21 at 3:05 PM with the Administrator, Clinical Manager, Alternate Administrator, and Administrative Assistant #1. During the interview, the Clinical Manager confirmed the aide care plan should be detailed and patient specific.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the home health aide (HHA) completed tasks only according to the aide care plan for 1 of 1 active records of a patient receiving home health aide services (#3). An undated agency policy titled “Home Health Aide Care Plan” indicated but was not limited to: “Policy: A complete and appropriate Care Plan, identifying duties to be performed by the Home Health Aide, shall be developed by a Registered Nurse or Therapist. All home health aide staff will follow the identified plan … Special Instructions: … 6. The Home Health Aide cannot be responsible for performing any procedure that is not assigned to him/her in writing by the Registered Nurse/Therapist ….” An undated agency job description titled “Position: Home Health Aide” indicated by was not limited to “… Position Summary: Provides personal care services under the direction of the Registered Nurse or Therapist … Essential Functions/Areas of Accountability … 4. Assists in the administration of medications that are ordinarily self-administered under the direction and supervision of the Registered Nurse (per state nurse practice laws and Agency policy) ….” The clinical record of Patient #3 was reviewed on 10/20/21 and indicated a start of care date of 2/26/18 with patient diagnoses including but not limited to multiple sclerosis, hyperglycemia [high blood sugar], and urine retention. The record included a plan of care (POC) for the recertification period 10/8/21 – 12/6/21, which indicated the patient was to receive skilled nursing (SN) and home health aide services. The POC indicated the aide tasks were to include “… assist with ADLs, bathing, meal prep, meal set up, light housekeeping, monitor for choking or s/s [signs and/or symptoms] of infection. HHA to report any concerns to SN … [Patient #3] is mostly bedfast and requires around the clock care. She is dependent for any transfers. HHA to monitor skin for any breakdown and report any wounds to SN ….” The record also included an “Aide Care Plan” documented and signed by RN #2 on 10/11/21. The care plan indicated the aide tasks to be completed “Every Visit” were “Temperature … Pulse … Respirations … Blood Pressure … Bed Bath – Partial/Complete … Personal Care … Assist with Dressing … Hair Care … Skin Care … Check Pressure Areas … Oral Care … Assist with Elimination … Ostomy Care … Mobility Assist: Bed … Positioning – Encourage: Assist every 2 hrs … Meal Preparation … Assist with Feeding … Encourage Fluids … Light Housekeeping,” and the task “Shampoo” was to be completed “Weekly.” A home visit observation was conducted on 10/20/21 at 9:55 AM with Patient #3 and Home Health Aide #1. During the visit, HHA #1 confirmed the patient intermittently had a “heat rash” and the aide would apply either a diaper rash cream or Nystatin (medication used to treat fungal infections) powder to the area. The aide confirmed she applied the Nystatin powder when the rash was “not that bad.” The aide care plan failed to evidence the aide was to apply any creams or lotions and directions on when to apply. The visit notes for HHA visits conducted during the certification period 8/9/21 – 10/7/21 indicated HHA #1 completed 26 visits for Patient #3. All 26 visit notes failed to evidence the aide obtained the patient’s temperature, pulse, respirations, and blood pressure as directed on the care plan to be completed with every visit. An interview was conducted on 10/22/21 at 3:05 PM with the Administrator, Clinical Manager, Alternate Administrator, and Administrative Assistant #1. During the interview, the Clinical Manager confirmed HHAs should only complete tasks as indicated on the aide care plan and within their scope of practice.