Every finding on record at Golden Heart Health Services LLC

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 05/09/2024-05/10/2024 & 05/13/2024-05/14/2024 Active Census: 43 At this Emergency Preparedness survey, Golden Hearts Health Services LLC was not found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR completed on 05/20/2024 by A4.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement policies and procedures that align with the hazards identified within its risk assessment for 1 of 1 Emergency Preparedness Program review. Findings include: A policy titled "Emergency Preparedness Management Policy" was provided by the Administrator on 05/13/2024. The policy indicated that the agency would analyze emergencies and develop and maintain a written plan describing the process, readiness, and ability to implement it. A review of the Emergency Preparedness Plan for 2023 and 2024 failed to evidence policies and procedures for the following identified hazards within the risk assessment: tornadoes, severe thunderstorms, snowfall, external flooding, and Epidemics. Additional emergency events identified in the risk assessment included the following: blizzards, ice storms, earthquakes, temperature extremes, drought, wildfires, dam inundation, and chemical, biological, nuclear, and explosives. During an interview on 05/13/2024 at 1:20 PM, the Administrator stated she could not find any policies aligning with the agency's identified hazards for 2023 and 2024. The Administrator stated the former Administrator had deleted information from the computer and that papers were everywhere. The Administrator stated she was left to clean up a mess.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain documentation of its training and testing program for emergency preparedness, as set forth in the emergency plan for 1 of 1 Emergency Preparedness Program review. Findings include: 1. A 2023 "Emergency Preparedness Plan" was provided by the Administrator on 05/10/2024. The plan indicated that the agency would conduct tabletop and actual drills quarterly or as needed. 2. An undated policy titled "Emergency Preparedness Management Policy" was provided by the Administrator on 05/13/2024. The policy indicated that staff members were supposed to participate in an annual desktop drill. 3. A review of the agency's 2023 and 2024 Emergency Binder on 05/13/2024 failed to evidence that the staff completed a tabletop exercise, community exercise, or emergency event for 2023 and 2024. Additionally, the agency failed to provide policies and procedures based on the identified hazards within the risk assessment and failed to evidence staff training related to the agency's policies and procedures that align with the agency's identified hazards. 4. During an interview on 05/13/2024 at 1:20 PM, the Administrator stated she could not find any policies aligning with the agency's identified hazards for 2023 and 2024. The Administrator stated the former administrator had deleted information from the computer or hid the 2023 tabletop exercise in a file somewhere. The Administrator stated she was left to clean up a mess.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct and document the analysis of all tabletop drills, emergency events, and the agency response to the analysis for 1 of 1 Emergency Preparedness Programs. Findings include: A 2023 "Emergency Preparedness Plan" was provided by the Administrator on 05/10/2024. The plan indicated the agency would conduct tabletop exercises and actual drills quarterly or as needed. The plan did not address the analysis of all tabletop exercises, drills, emergency events, the agency's response to the analysis, and what lessons were learned. A review of the Emergency Preparedness Binder failed to provide evidence staff attended a tabletop exercise or community-based exercise for 2023. During an interview on 05/13/2024 at 1:20 PM, the Administrator stated she started four months ago and just started working on the Emergency Preparedness program. She stated that the former Administrator probably hid the 2023 tabletop exercise in a file somewhere.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: 05/09/2024 to 05/14/2024 12-Month Unduplicated Skilled Admissions: 5 Extended survey announced: 05/13/2024 During this Federal Recertification Survey, Golden Heart Health Services was found to be out of compliance with Conditions of Participation §484.45 Reporting of OASIS Information, §484.60 Care planning, coordination of services, and quality of care.; §484.80 Home health aide services. Based on the Condition-level deficiencies during the 05/14/2024 survey, your HHA was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 05/13/2024. 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 programs for a period of two years beginning 05/14/2024 and continuing through May 13, 2026. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings.

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to transmit OASIS information for all skilled Medicaid patients utilizing federally funded health plans not meeting the transmittal requirements and failed to submit OASIS (Outcome Assessment Information Set) within 30 days of assessment completion (See tag G372) The cumulative effect of this systemic problem resulted in the home health agency to be out of compliance with the Condition of Participation of 42 CFR 484.45, Reporting of OASIS information. Findings include: 1. A policy titled “Encoding and Reporting OASIS Data” indicated but was not limited to “ … The agency will electronically report all OASIS data … transmit assessment data on all skilled (Medicare and Medicaid) clients receiving services from Agency … ” 2. A policy titled “Transfer Policy” indicated but was not limited to “ … The Transfer OASIS will be conducted within 48 hours of (or knowledge of) transfer to another home health or higher level of care facility … ” 3. A review of an agency document titled “ OASIS (a comprehensive assessment designed to collect information related to a home care recipient’s demographic, clinical, functional, and service needs) Agency Final Validation.” The document was for the reporting period of the year to date, which indicated that Inactive Patients #1 had a section titled “RFA (Reason For Assessment) listed as 05, indicating other follow-up OASIS assessments were submitted on 02/01/2024. The agency validations failed to report transfer submissions for Patients #1 and #7 Medicaid skilled patients utilizing federally funded health plans. 4. A review of the inactive clinical record for Patient #1, discharge date 08/29/2023, contained a plan of care for the recertification period of 07/04/2023 to 10/11/2023. The plan of care indicated Patient #1 received Skilled Nursing 11 hours a day for 7 days a week to provide total care for nutritional and medication management per gastronomy tube (a tube inserted into the stomach to provide liquid nutrition and medication), blood sugar management, oral suctioning, bladder and incontinence care, repositioning, transfers with a Hoyer, and assessments. A review of physician-signed orders indicated on 08/26/2024, Patient #1’s Home Health Agency (HHA) services were placed on due hospitalization. An order dated 08/29/2024, revealed Patient #1 was discharged due to death. A review of the comprehensive reassessment dated 08/16/2023 indicated the OASIS Assessment reason, Other follow-up for the certification period 07/14/2023 to 09/11/2023. The narrative indicated a resumption of care assessment completed after a hospital stay from 07/29/2023 to 08/13/2023 for coughing and respiratory distress. The record failed to evidence a transfer OASIS was completed for 08-26-2023. During an interview on 05/09/2024 at 3:22 PM, when queried regarding the transfer OASIS location in the clinical record, the Administrator indicated that the only OASIS in Patient #1’s chart is the other follow-up OASIS. The Administrator stated, “Someone didn’t do it.” 5. A review of the inactive clinical record for Patient #7, discharge date 01-22-2024, contained a plan of care for the recertification period of 11/21/2023 to 01/19/2024. The plan of care indicated that Patient ##7 received Skilled Nursing 1 hour a day for 2 days a week for ileostomy (a surgical opening that connects the ileum to the abdominal wall for stool to leave the body) and hearing aid maintenance due to disease processes that hinder the patient from completing these skills. A review of physician-signed orders indicated on 01/22/2024 that Patient #7 may be discharged from Golden Heart Health Services due to hospital admission at the end of their recertification, and the Power of Attorney was notified. A review of the comprehensive assessment completed in the clinical record for Patient #7 indicated that the last assessment was completed on 12/29/2023 and was a resumption of care assessment for the certification period of 11/12/112 to 01/19/2024. The record failed to evidence a transfer OASIS was completed for 08/26/2023. During an interview on 05/10/2024 at 2:11 PM, when queried regarding the transfer OASIS location in the clinical record, the Administrator indicated that it should have been done and wasn’t.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to submit OASIS (Outcome Assessment Information Set) within 30 days of assessment completion for 1 of 2 inactive records reviewed. (Patients: #1) Findings Include: 1. A policy titled “Encoding and Reporting OASIS Data” indicated but was not limited to, “ … Agency will encode and electronically transmit each completed OASIS assessment to the CMS system within 30 days of completing the assessment of the client … ” 2. A review of an agency document titled “ OASIS (a comprehensive assessment designed to collect information related to a home care recipient’s demographic, clinical, functional, and service needs) Agency Final Validation.” The document was for the reporting period of the year to date, which indicated that Inactive Patients #1 had a section titled “RFA (Reason For Assessment) listed as 05, indicating other follow-up OASIS assessments were submitted on 02/01/2024 and the M0090 date ( date of completion) of 02-08-2023 with message -3330 indicating record submitted late; more than 30 days after the M0090 date of the record. 3. A review of the inactive clinical record for Patient #1, discharge date 08/29/2023, contained a comprehensive reassessment dated 08/16/2023. The OASIS Assessment reason was for Other follow-up for the certification period 07/14/2023 to 09/11/2023. The narrative indicated a resumption of care assessment completed after a hospital stay from 07/29/2023 to 08/13/2023 for coughing and respiratory distress. During an interview on 05/09/2024 at 3:22 PM, when queried regarding the submissions of OASIS, the Administrator indicated that the Director of Clinical was to review and submit the OASIS within 30 days of the date of completion.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients were provided with the correct and updated contact information for the administrator for 4 of 5 home visits conducted. (Patients: #4, 5, 8, and 9) Findings Include: 2. During a home visit on 05/10/2024 at 10:05 AM, the admission packet of Patient # 4 was reviewed and found not to have the Administrator's name and contact information. The agency failed to provide the patient and/or caregiver with updated agency contact information. An interview on 05/10/2024 at 10:05 AM, Patient #4 indicated they did not know who the Administrator was for the agency. 4. During an observation on 05/13/2024 at 10:50 AM, Patient #8's admission packet did not contain the Administrator's name and contact information. The agency failed to provide the patient and/or caregiver with updated agency contact information. During an interview on 05/13/2024 at 11:40 AM, Patient #8 indicated they did not know who the agency’s Administrator was or how to file a complaint with the agency. 1. A policy titled “Client/Family Grievance Policy” indicated but was not limited to “All clients admitted to the Agency will be informed of their right to voice grievances to the agency … Clients will be presented with the Agency … correct Contact numbers … ” 2. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, when queried regarding the agency folder, Patient #5 provided a red folder for review. A review of the red folder contained Golden Heart Health Services admission documents but failed to have the administrator's contact information. Patient #5 confirmed they did not know who the Administrator was or how to contact them. During an interview on 05/10/2024, at 11:00 AM, the Home Health Aide (HHA) 3, the caregiver for Patient #5, indicated they were unaware of the contact information for the Administrator and only knew the scheduler, Admin 1. 3. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, when queried regarding the agency information, Patient #9 obtained a red folder from their dresser drawer. A review of the red folder contained Golden Heart Health Services admission documents and listed the current Administrator as Former Employee 7, the agency’s previous Administrator. During an interview on 05/13/2024 at 10:53 AM, the Registered Nurse (RN) 1 confirmed Patient #9’s folder indicated Former Employee 7 as the current Administrator. RN 1 stated, “That is old and needs to be updated.”

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide services as ordered on the plan of care (POC) for 4 of 7 active record reviews. (Patient #2, #3, #6, #8) Findings include: 6. A review of Patient #3's record, start of care (SOC) dated 01/22/2024, certification period 01/22/2024 to 03/21/2024, included a POC with orders for skilled nursing services 1 hour a day, one day a week for 26 weeks for medication box fill. The agency failed to provide skilled nursing services from 01/22/2024 to 03/05/2024 and failed to document a reason why. 7.A review of Patient #8's record, the start of care (SOC) dated 01/05/2024, certification period 01/05/2024 to 03/04/2024 included a POC with orders for Home Health Aide (HHA) services 6 hours a day, four days a week for 26 weeks. The agency failed to document why HHA services were not provided from 01/05/2024 to 02/15/2024 and failed to provide HHA services from 02/15/2024 to 03/04/2024 due to staffing availability. A certification period from 03/05/2024 to 05/03/2024 included a POC with orders for skilled nursing services 1 hour a week for 26 weeks for medication box fill and Home Health Aide (HHA) services 4 hours a day four days a week for 26 weeks. The agency failed to provide HHA services from 03/05/2024 to 03/13/2024 due to staff availability. 8. During an interview on 05/13/2024 at 1:35 PM, the Administrator indicated a late start in services is acceptable because family members are there to help the patient until the agency can start services. 1. A policy titled "Clinical Documentation" was provided by the Administrator on 05/10/2024. The policy states that if services are not provided as per the physician's order, the reason for missed visits must be documented and reported to the physician. 2. An undated document titled "Rights of the Client" was provided by the Administrator on 05/13/2024. The document indicated the patient should receive all services outlined in the plan of care (POC) and comprehensive assessment. The agency was to document all problems and efforts made to resolve the problem in the patient record. 3. A review of Patient #2's record, start of care (SOC) dated 03/11/2024, certification period 03/11/2024 to 05/09/2024 included a plan of care (POC) with orders for home health aide (HHA) services 10 hours a day five days a week. The agency failed to aides services from 03/14/2024 to 04/07/2024. The agency failed to document a reason why HHA services were not provided. 4. A review of Patient #6's record, start of care (SOC) date 03/13/2024, certification period 03/13/2024 to 05/11/2024 included a POC with orders for HHA services 10 hours a day for six days a week, and skilled nursing services 1 hour a week every week for medication refill and assessment. The agency failed to provide services for March, April, and May 2024. 5. During an interview on 05/09/2024 at 12:30 PM, the Administrator stated they were waiting on payor approval for Patient #2. The Administrator stated that no visits had been made for Patient #6 as they were waiting on payor approval. Due to this, the agency had to put HHA services on hold. The Administrator said the physician did not approve as the medication list for Patient #6 was incorrect. The Administrator was not able to provide a reason for the need for HHA services if Patient #6 could go without any services for three months.

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 agency failed to complete an initial assessment within 48 hours of a referral for 4 of 7 active record reviews. (Patient #2, #3, #6, #8) Findings include: 3. A review of Patient #3's record, the start of care (SOC) date 01/22/2024, and certification period 01/22/2024 to 03/21/2024 included an unsigned referral dated 01/08/2024. The agency failed to complete the initial assessment within 48 hours of the referral. During an interview on 05/10/2024 at 1:00 PM, the Administrator indicated she was unable to find communication notes for reason of admission being delayed past 48 hours. 5. A review of Patient #8's record, start of care (SOC) date 01/25/2024, certification period 01/05/2024 to 03/04/2024 included a referral date 01/15/2024. The agency failed to complete the initial assessment within 48 hours of the referral. 1. A policy titled "Comprehensive Client Assessment" was provided by the Administrator on 05/10/2024. The policy indicated that the initial assessment must be conducted within 48 hours of a referral. 2. A review of Patient #2's record, start of care (SOC) date 03/11/2024, certification period 03/13/2024 to 05/11/2024 included a referral date 02/29/2024. The agency failed to complete the initial assessment within 48 hours of the referral. 3. A review of Patient #6's record, SOC date 03/13/2024, certification period 03/13/2024 to 05/11/2024, included a referral date of 02/29/2024. The agency failed to complete the initial assessment within 48 hours of the referral.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure staff reviewed patient medications during a home visit for 1 of 1 recertification observations with a nurse. (Clinical Supervisor) Findings include: 1. A policy titled "Medication Reconciliation" was provided by the Administrator on 05/10/2024. The policy indicated but was not limited to the nurse reviewing and reconciling all medications at each nursing visit and recertification (60 days). 2. During a home visit on 05/09/2024 at 3:00 PM, the Clinical Supervisor failed to review each medication bottle against the care plan/medication profile for Patient #2's 60-day recertification visit. The Clinical Supervisor reviewed the admission packet but could not locate the plan of care or medication/wound care list. The Clinical Supervisor stated that Entity 1 handles the wound treatment and medications. 3. During an interview on 05/10/2024 at 8:45 AM, the Administrator stated that the nurse was expected to compare each medication bottle against the medication profile or plan of care at the time of recertification to ensure the patient received it correctly. 410 IAC 17-14-1(a)(1)(B)

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 observation, record review, and interview, the agency failed to have a signed plan of care (POC) or a verbal POC order from the primary physician before providing services and treatments (See tag G572): failed to document teaching and education provided to a patient (See tag G574); failed to follow physician orders for setting up a weekly medication planner (See tag G580); failed to ensure the agency coordinated care with another agency that was providing care to a patient (See tag G608); failed to ensure the patient's visiting schedule was in the home (See tag G614); failed to provide a copy of written medication and treatment instruction was in the home (See tag G616); failed to ensure the patients failed to ensure staff reviewed patient medications during a home visit (See tag G618); and failed to provide the patient with contact information for the clinical manager (See tag G622). The cumulative effect of this systemic problem 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 of 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 have a signed plan of care (POC) or a verbal POC order from the primary physician before providing services and treatments to patients for 3 of 7 active patient record reviews. (Patient #3, #4, #8) Findings include: 1. An undated policy, titled "Physician/Allowed Non-Physician Practitioner (NNP) orders," indicated all medication, treatments, and services provided to patients must be ordered by a physician. These orders may be received by phone or in writing and must be signed. 2. The record review for Patient #3, certification period 03/22/2024 to 05/20/2024, revealed patient care was provided to Patient #3 without a verbal order or physician-signed order on 03/27/2024. During an interview on 05/10/2024 at 1:00 PM, the Administrator indicated she understood the POC needs to be signed or a verbal order of services to be provided until POC is signed. The Administrator was unable to locate verbal orders, in Patient #3’s chart, for visit provided on 03/27/2024. 3. The record review for Patient #4, certification period 03/23/2024 to 05/21/2024, revealed patient care was provided to Patient #4 without a verbal order or physician-signed order on 03/25/2024. 4. The record review for Patient #8, certification period 05/04/2024 to 07/02/2024, revealed patient care was provided to Patient #8 without a verbal order or physician-signed order for the following days: 05/07/2024, 05/08/2024, 05/09/2024. 5. During an interview on 05/14/2024 at 9:45 AM, the Administrator indicated that services are not provided without orders. Once orders are signed, the agency will start providing care to patients. 410 IAC 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to document teaching and education provided to a patient for 1 of 1 record reviews with known cellulitis (infection). (Patient #6) Findings include: A policy titled "Plan of Care" was provided by the Administrator on 05/10/2024. The policy indicates the plan of care includes providing instruction, education, and other appropriate items. A review of Patient #6's record, SOC date 03/13/2024, certification period 03/13/2024 to 05/11/2024, included a plan of care (POC) and clinical summary that indicated Patient #6 had 4 open and several scabbed chronic edema blisters to bilateral shins. The clinical summary indicated Patient #6 applies an antibiotic ointment daily and that the blisters heal but then overdoes it one day, and the blisters come back. The POC and clinical summary did not evidence the nurse provided instructions, teaching, or education regarding wound care and infection prevention. On 05/14/2024 at 12:30 PM, during an interview, the Administrator was questioned about the lack of specific intervention or education for the open areas on Patient #6's bilateral shins. After reviewing Patient #6's record, the Administrator stated that the patient had cellulitis. It was expected that the nurse would detail in the POC and clinical summary what was taught about wound care and infection prevention. The agency failed to document teaching and education for a patient with cellulitis. 410 17-13-1(a)(1)(D)(i-xiii)

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 observation and record review the agency failed to follow physician orders for setting up weekly medication planner, affecting 1 of 1 observed medication set up. (Patient #8) An undated policy, titled “Medication Set Up Policy,” indicated that the agency will set up medications as ordered by the physician; the nurse should ensure that he/she is correctly filling the medication planner. During an observation on 05/13/2024 at 10:50 AM, Registered Nurse (RN) 3 placed Aspirin (used for thinning blood) in the medication planner every day. The nurse failed to follow the order on the medication profile, which indicated Aspirin should be given twice per week. The record review for Patient #8, certification period 05/04/2024 to 07/02/2024, included a medication profile that indicated Aspirin is to be given twice weekly. The RN failed to correctly set up the medication planer as ordered by the physician. 410 IAC17-13-1(a)

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the agency coordinated care with another agency that was providing care for 3 of 7 active record reviews. (Patient #2, #4, #9) Findings include: 5. A review of the clinical record for Patient #9, who started care on 01/03/2024, revealed a plan of care for the recertification period of 05/02/2024 to 06/30/2024. The plan of care indicated that Patient #9’s residence was listed at Entity 4, an assisted living facility. The plan of care contained a section titled “ Coordination of Care” that revealed the primary care physician’s name and indicated Entity 4 but failed to list the person with whom they coordinated care. A review of agency documents titled “Patient Communication Log,” dated 01/03/2024 through 05/13/2024, indicated a message on 01/31/2024 entered by the Director of Nursing. The message indicated a call was placed to Entity 4, and a message was left for a return call. The logs failed to evidence any further follow-up or coordination of care with the nursing staff of Entity 4. During an interview on 05/13/2024 at 11:10 AM, when queried about the nurse from Golden Heart Health Services coordinating care for Patient #9, Person 5, Entity 4’s floor nurse for Patient #9, stated, “ No, not that I am aware of. I don’t recall them speaking to me regarding Patient #9.” 5. The record review for Patient #4, certification period 03/23/2024 to 05/21/2024, included a communication log with no documented communication between agency field staff, physician, or Entity 2 since the start of the certification period. During an interview on 05/10/2024 at 10:00 AM, HHA 2 indicated that patient #4 has been having issues with blood sugar levels every day; HHA 2 has verbally reported this to the agency and Entity 2 but has never documented this verbal communication in the patient's chart. During a home visit on 05/13/2024 at 8:55 AM, Patient #4 informed HHA 2 that their blood sugar was 79 before breakfast. The Clinical Supervisor indicated Patient #4's blood sugar is managed by Entity 2. Abnormal readings would be reported to the patient's primary physician if Home Health Aide (HHA) 2 reported abnormal readings to the agency; the registered nurse would report abnormal blood sugar levels to a physician at recertification, and supervisory visits, and a verbal report would be provided to Entity 2's nurse. She indicated the communication would be documented in the system under the patient's communication log. During an interview on 05/13/2024 at 9:40 AM, Person 8 indicated the agency has no communication binder at Entity 2. Person 8 indicated they have never received a report on a patient from the agency's HHA or Nurses; every few months, the nurse from the agency requests a medication list. During an interview on 05/13/2024 at 9:50 AM, The Clinical Supervisor indicated that the agency provides Entity 2 with a list of patients it is providing aide services to. During an interview on 05/13/2024 at 1:35 PM, the Administrator indicated staff should be reporting anything that is a concern to the physician. 1. A policy titled "Coordination of Client Services" was provided by the Program Director on 05/10/2024. The policy indicated that the agency was to coordinate care with all disciplines to ensure patient needs and goals were met. 2. During an observation on 05/09/2024 at 3:00 PM, the Clinical Supervisor assessed three of the six wounds to Patient #2's bilateral buttocks, sacral area, and mid-lower back. Patient #2 and the Clinical Supervisor stated that Entity 1 measures and provides the treatment for the wounds. The Clinical Supervisor stated that the patient doesn't like to have the dressings removed and areas assessed. 3. A review of Patient #2's record, start of care (SOC) date 03/11/2024, certification period 03/13/2024 to 05/11/2024 included a plan of care (POC) and a clinical summary indicating Patient #2 had a sacral decubitus ulcer that was being cared for by Entity 1. The clinical summary indicated the Clinical Supervisor could not visualize the wound per the patient's request. The agency failed to evidence coordination between the agency and Entity 1 regarding the care, type of treatment/instructions, and progress toward healing for six wounds on the bilateral buttocks, sacral area, and mid-lower back since the SOC. 4. During an interview on 05/10/2024 at 2:30 PM, the Administrator stated that the nurse was expected to coordinate care with Entity 1 and assess all wounds at each nursing visit. The Administrator reviewed Patient #2's record and was made aware there was no coordination between the two agencies. The Administrator called Entity 1 requesting their wound documentation. Entity 1's nursing visit notes from 04/24/2024 to 05/08/2024 evidenced that Patient #2 had three stage II (open ulcer) wounds to the right buttock and both upper thighs and a stage III (exposed deep tissue and fat) wound to the coccyx (tailbone). Entity 1's visit notes did not evidence care coordination with the agency. The agency failed to coordinate wound care with Entity 1.

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 record review and interview, the agency failed to provide the patients and caregivers a visit schedule for the frequency of visits provided by the agency staff in 4 of 5 home visits conducted. (Patients: #4, 5, 8, and 9) Findings include: 1. A review of an agency document titled “Right of the Client” indicated but was not limited to, “As a client of Golden Heart Health Services Home Health Agency (HHA), you have the following rights: … be informed about … in advance of, and during treatment … The care to be furnished … The disciplines that will furnish the care …The frequency of visits … ” 2. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, a red folder was provided for review when queried regarding the agency folder. A review of the red folder contained Golden Heart Health Services admission documents but failed to include a schedule of agency staff’s frequency of treatments. During an interview on 05/10/2024 at 1:33 PM, Registered Nurse (RN) 2 confirmed they set up Patient #5’s medications weekly, and the Patient has an HHA five days a week. RN 2 further indicated they were unaware that they needed to provide service schedule frequency of staff to Patient #9 and their caregivers. 3. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, when queried regarding the agency information, Patient #9 obtained a red folder from their dresser drawer. A review of the red folder contained Golden Heart Health Services admission documents but failed to include a schedule of agency staff’s frequency of treatments. During an interview on 05/13/2024 at 10:53 AM, RN 1 confirmed the folder did not contain a schedule of the frequency of visits by agency staff and should be located in the front of the red folder. 2. During a home visit on 05/10/2024 at 10:05 AM, the admission packet (red folder) of Patient # 4 was reviewed and found to have an agency calendar dated 04/2023. No current agency calendar was found in the patients' red folder or home. The agency failed to provide the patient and/or caregiver with an updated agency services calendar. 4. During a home visit on 05/13/2024 at 10:50 AM, Patient #8's admission packet (red folder) did not contain an agency calendar, and one was not found in the home. The agency failed to provide the patient and/or caregiver with an updated agency services calendar. 6. During an interview on 05/09/2024 at 9:25 AM, the administrator indicated that the admission packet (red folder) is usually placed on top of the refrigerator and should contain all documents related to the patient. The staff should review the red folder every visit and at recertification, and the red folders should be updated as needed. 7. During an interview on 05/13/2024 at 1:35 PM, the administration indicated the red folder should include a current plan of care, medication list, schedule, allergy list, and Braden score.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide the patients with a medication schedule and instructions for 4 of 5 home visits. (Patients: #4, 5, 8, and 9) Findings include: 2. During a home visit on 05/10/2024 at 10:05 AM, the admission packet (red folder) of Patient # 4 was reviewed and found to have a medication profile dated 07/28/2022. No current documentation was found in the patient's red folder. The agency failed to provide the patient and/or caregiver with an updated medication schedule and instructions. 4. During a home visit on 05/13/2024 at 10:50 AM, Patient #8's admission packet (red folder) did not contain a medication profile. The agency failed to provide the patient and/or caregiver with an updated medication schedule and instructions. 6. During an interview on 05/09/2024 at 9:25 AM, the administrator indicated that the admission packet (red folder) is normally placed on top of the refrigerator and should contain all documents related to the patient. The staff should review the red folder every visit and at recertification, and the red folders should be updated as needed. 7. During an interview on 05/13/2024 at 1:35 PM, the Administration indicated the red folder should include a current plan of care, medication list, schedule, allergy list, and Braden score. 1. A policy titled “Medication Profile” indicated but was not limited to “ … The Medication Profile shall be reviewed by a Registered Nurse every sixty (60) days and updated whenever there is a change or discontinuation in medication … Medication profiles created through electronic point of care documentation systems will have a copy in the client records, and the client’s home if the agency is setting up or managing the medication administration … ” 2. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, when queried regarding the agency folder with the medication list, Patient #5 provided a red folder for review. Patient #5’s red folder contained admission documents from Golden Heart Health Services. A review of the documents failed to evidence a medication list. When queried regarding a medication list and who sets up their medication, Patient #5 indicated the nurse comes once a week and sets up their medications, and they did not leave a medication list. During an interview on 05/10/2024 at 1:33 PM, Registered Nurse (RN) 2 confirmed they set up Patient #5’s medications weekly. RN 2 further indicated they brought a medication list with them to set up Patient #5’s medications, and they were not aware that they needed to provide a medication list to Patient #9 and their caregiver. 3. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, when queried regarding the agency information, Patient #9 obtained a red folder from their dresser drawer. A review of the red folder contained admission documents from Golden Heart Health Services. A review of the documents failed to evidence a medication list. Patient #9 indicated they were not given one regarding a medication list when queried. During an interview on 05/13/2024 at 10:53 AM, RN 1 confirmed the folder did not contain a medication list and that the medication list should be located in the front of the red folder.

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 agency failed to ensure the patient received a current copy of medication and treatment instructions for 5 of 7 active record reviews. (Patients #2, #4, #5, #8, #9) Findings include: 5. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, when queried regarding the agency folder with the plan of care, Patient #5 provided a red folder for review. Patient #5’s red folder contained admission documents from Golden Heart Health Services. A review of the documents failed to evidence a plan of care or treatments being provided by agency staff. During an interview on 05/10/2024 at 1:33 PM, Registered Nurse (RN) 2 confirmed they set up Patient #5’s medications weekly, and the Patient has an HHA five days a week. RN 2 further indicated they were not aware that they needed to provide a plan of care with the treatments being provided by agency staff to Patient #9 and their caregiver. 6. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, when queried regarding the agency information, Patient #9 obtained a red folder from their dresser drawer. A review of the red folder contained admission documents from Golden Heart Health Services. A review of the documents failed to provide evidence of a plan of care or treatments provided by agency staff. Patient #9 indicated they were not given one. During an interview on 05/13/2024 at 10:53 AM, RN 1 confirmed that the folder did not contain a plan of care with treatments by agency staff and that the plan of care should be located in the front of the red folder. 4. During a home visit on 05/10/2024 at 10:05 AM, the admission packet (red folder) of Patient # 4 was reviewed and found to have a medication profile dated 07/28/2022, a calendar dated 04/2023 and a plan of care for the certification period of 03/29/2023 to 05/27/2023 and an aide plan of care dated 01/06/2022. No current documentation was found in the patients' red folder. The agency failed to provide the patient and/or caregiver with updated medication and instruction information. 6. During a home visit on 05/13/2024 at 10:50 AM, Patient #8's admission packet (red folder) did not contain a plan of care and medication list. The agency failed to provide the patient and/or caregiver with current medication and treatment instructions. 1. A policy titled "Medication Profile" was provided by the Administrator on 05/10/2024. The policy indicated that the agency was to provide the patient with a copy of the medication profile. 2. An undated document in the admission packet titled "Rights of the Client" was provided by the Administrator on 05/13/2024. The document indicated the patient has the right to be informed about care being furnished, the plan of care, and access to their information. 3. During a home visit observation on 05/09/2024 at 3:00 PM, the Clinical Supervisor reviewed Patient #2's admission packet. The packet did not contain written instructions on medications and treatments. The Clinical Supervisor stated that the agency was responsible for the aide services, and Entity 1 was responsible for the medications and treatment list for the patient. The agency failed to provide the patient with written medication/treatment instructions. 4. During an interview on 05/13/2024 at 1:43 PM, the Administrator stated that the red admission folders in the home should contain the plan of care and medication list. The agency failed to provide a copy of written instructions to the patient that included any treatments to be administered by the agency personnel or personnel acting on behalf of the agency.

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 record review and interview, the agency failed to ensure all patients were provided with a copy of written instructions outlining the name and contact information of the home health clinical manager/director of nursing for 2 of 5 home visits conducted. (Patients: #5 and 9) Findings Include: 1. A policy titled “Client/Caregiver Education” indicated but was not limited to “Clients and their caregivers will be provided with the information necessary … To assure the client has adequate information to communicate effectively with the agency representatives and other health providers … ” 2. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, when queried regarding the agency folder, Patient #5 provided a red folder for review. A review of the red folder contained Golden Heart Health Services admission documents but failed to have the contact information of the Clinical Manager. Patient #5 confirmed they did not know who the Clinical Manager was or how to contact them. 3. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, when queried regarding the agency information, Patient #9 obtained a red folder from their dresser drawer. A review of the red folder contained Golden Heart Health Services admission documents and listed the Director of Nursing with the current Administrator’s name. During an interview on 05/13/2024 at 10:53 AM, Registered Nurse (RN) 1 confirmed that Patient #9’s folder contained a document that indicated the current Administrator was listed as the Director of Nursing. RN 1 stated, “That is old and needs to be updated.”

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to implement a performance improvement project for 2023 and 2024 for 1 of 1 quality performance improvement projects (QAPI) review. Findings include: A policy titled "Quality Assessment and Performance Improvement (QAPI)" was provided by the Administrator on 05/14/2024. The policy indicated that the agency must conduct a performance improvement project(s) annually, document the reason for conducting the project, and measure progress achieved. The governing body was responsible for ensuring an ongoing program for quality improvement and patient safety was defined, implemented, and maintained. A review of the 2023 and 2024 QAPI programs failed to evidence that a performance improvement project (PIP) was developed, ongoing, or completed for those years. A review of the Governing Body meeting minutes dated 11/24/2024 and 01/31/2024 failed to evidence approval of a PIP project or the frequency and detail of the data collected. During an interview on 05/14/2024 at 12:00 PM, the Administrator stated she had not implemented a PIP for this year and was unsure where the former Administrator placed any 2023 PIPs. 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 the clinical staff followed the agency’s policies for infection control practices with bag technique and hand hygiene in 4 of 5 home visit observations. (Employees: RN 3, HHA 2, 3, and 4) Findings Include: 5. During an observation on 05/13/2024 at 8:55 AM, HHA (Home Health Aide) 2 did not perform hand hygiene before gloving twice while providing personal care to Patient #4. The HHA failed to maintain infection control during the home visit for patient #4. 6. During an observation on 05/13/2024 at 10:50 AM, RN 3 placed her nursing bag directly on Patient #8 chair without a barrier. RN 3 provided medication setup for patients but did not use hand hygiene or gloves prior to touching the medication. After RN 3 provided care to the patient, she removed gloves but did not perform hand hygiene, then continued to touch items throughout the home and prepared food for Patient # 8. RN 3 washed hands at the kitchen sink for less than 20 seconds before removing food from the microwave and placing the soup bowl with a napkin on the uncleaned rollator seat for the patient to eat. The HHA failed to maintain infection control during the home visit for patient #8. During an interview on 05/13/2024, the Administrator indicated she had instructed staff to place the drape down before placing the bag on the surface, and all equipment needs to be wiped off before being placed back in the bag. 1. A policy titled “Nursing Bag” indicated but was not limited to “ … The inside of the bag and its contents are considered clean. Therefore: Handwashing must occur before entering the bag … All items removed from the bag should be cleaned before returning to the bag … When in a client’s home, place a waterproof disposable barrier on a clean and dry surface then place the bag down on the barrier … ” 2. A policy titled “Infection Prevention/Control” indicated but was not limited to, “ … To reduce the risk of transmission of microbes from both recognized and unrecognized sources of infection … Hands are washed if contaminated with blood or body fluid, immediately after gloves are removed, between client contacts, and when indicated to prevent the transfer of microorganisms between other clients or the environment … ” 3. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, observed HHA 3 assist Patient #5 with breakfast. The HHA went to the kitchen sink, performed hand washing, used their bare hand to turn the faucet off, obtained a paper towel, dried their hands, discarded the paper towel in the trash receptacle, and obtained gloves from their bag. The HHA used their clean hand to touch the dirty faucet to turn the water off and failed to re-wash their hands before reaching into their clean bag to obtain gloves. HHA 3 donned gloves and cooked the bacon for Patient #5. HHA 3 removed their gloves, discarded them into the trash receptacle, obtained new gloves from their bag, and donned the new gloves. The HHA failed to perform hand hygiene after removing their gloves and getting new gloves out of their clean bag. HHA 3 cooked Patient #5 scrambled eggs, removed their gloves, washed their hands at the kitchen sink, turned off the kitchen sink faucet with their bare hands, obtained a paper towel, and dried their hands. HHA 3 failed to use a paper towel to turn the faucet off and failed to rewash their hands after touching the dirty faucet. During an interview on 05/10/2024 at 11:37 AM, when queried regarding hand hygiene and infection control, HHA 3 indicated they should have used the paper towel to turn the water off. HHA 3 further confirmed hand hygiene is to be done anytime gloves are removed. 4. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, observed HHA 4 obtain a thermal scan temperature on Patient #9. The HHA entered the residence of Patient #9, placed their bag on the floor, and went to the sink to wash their hands. HHA 4 failed to place a barrier on a clean, dry surface and placed their bag on the barrier. The HHA obtained a paper towel, turned off the water, reached into their bag, obtained clean gloves, and discarded the paper towel in the trash receptacle. HHA 4 obtained the thermal scan thermometer out of their bag, took Patient #9’s temperature, and placed the thermometer back in their bag. HHA 4 failed to clean the thermometer before placing it back in the clean bag. HHA 4 reviewed Patient #9’s needs and placed their gloved hands in the scrub pockets. Afterward, the HHA picked up their bag with their gloved hands and left the residence. HHA 4 failed to remove their gloves and perform hand hygiene. During an interview on 05/13/2024 at 11:17 AM, when queried about what they saw during the visit with Patient #9 and HHA 4, the branch office Registered Nurse (RN) 1, who observed the visit, indicated that HHA 4 should not have placed their bag on the floor. RN 1 further indicated that the gloved hands were in their scrub pant pockets and that they did not perform hand hygiene.

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 observation, record review, and interview, the agency failed to ensure all Home Health Aides provided hands-on personal care as ordered per the plan of care (see Tag G802 ); the agency failed to ensure the Registered Nurse (RN) completed Home Health Aide Supervisory visits every 14 days (see tag G808 ), and failed to ensure the RN accurately documented supervisory visits. (see tag G818). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality of care in a safe environment for the Condition of Participation 42 CFR 484.80: Home health aide services.

Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all Home Health Aides (HHA) provided assistance with Activities of Daily Living (ADLS), including bathing, showering assistance, assistance with dressings, hair care, oral care, skin care, and nail care (hands-on care), as ordered per the plan of care for 2 of 5 active records reviewed of patients who received HHA services. (Patients: #5 and #9) Findings Include: 410 IAC 17-14-1(h)(1)-(14) 1. A policy titled “Home Health Aide Supervision” indicated but was not limited to “ … ensure that aides furnish care in a safe and effective manner, including but not limited to the following elements: Following the client’s plan of care for completion of tasks assigned to a home health aide by the registered nurse … ” 2. During a home visit at Patient #5’s residence on 05/10/2024 at 10:45 AM, observed HHA 3 assist Patient #5 with breakfast. Patient #5 indicated they ride bikes, do laundry, clean the bed sheets, cook together, and play dominos. During an interview on 05/10/2024 at 11:00 AM, HHA 3 confirmed that Patient #5 does not let them do hands-on care. Patient #5 does all her personal care herself. When asked if the HHA made the nurse aware, they indicated they made the office scheduler, Admin 1, aware. 3. A review of the clinical record for Patient #5, start of care 05-09-2023, contained an agency document electronically signed by RN 2 and dated 04/04/2024, titled “Aide Plan of Care.” The aide care plan indicated a frequency of 3 hours a day for 5 days a week for HHA services. The section titled “Assignment” indicated the HHA was to do the following each visit: obtain temperature, hair care, skin care, mouth/denture care, foot care, nail care, dressing, make the bed, light housekeeping (bedroom, bathroom, kitchen), clean equipment, take out the trash, prepare a meal, encourage fluids, personal care, shower, sponge bath in a chair, toileting/hygiene, and assist with walker ambulation. The HHA was assigned to shampoo, light housekeeping, bed linen change, dust, sweep, and vacuum weekly. A review of the documents titled “Aide Visit Note-Daily” dated 04/08, 04/09, 04/10, 04/11, 04/12, 04/15, 04/16, 04/17, 04/18, and 04/19/2024 failed to evidence any hands-on personal care had been provided by HHA 3. Only companionship, meal prep, and housekeeping duties were provided. During an interview on 05/10/2024 at 1:33 PM, when queried regarding HHA 3 and what personal care they provided for Patient #5, RN 2 indicated they had met HHA. RN 2 further indicated the HHA prepared meals and played games with Patient #5. RN 2 further indicated they get confused with the agency's Prior Authorization and Waiver sides. 4. During a home visit at Patient #9’s residence on 05/13/2024 at 10:37 AM, observed HHA 4 obtain a thermal scan temperature on Patient #9. The HHA asked Patient #9 if they could assist with showering or oral care. Patient #9 indicated they completed all that themselves and went to the dining room for meals. Patient #9 further indicated they shower in the evening. When RN1 queried Patient #9 about what the HHA did for them when they came, Patient #9 said they do my laundry and occasionally change my bed. During an interview on 05/13/2024 at 11:05 AM, HHA 4 indicated that Patient #9 was not their usual patient, and they were filling in. HHA 4 further revealed that when they see clients and the plan of care is not correct, they make the scheduler, Admin 1, aware. HHA 4 confirmed that this Patient needs personal care, not HHA services. 5. A review of the clinical record for Patient #9, start of care 01-03-2024, contained an agency document electronically signed by RN 4 and dated 05/01/2024, titled “Aide Plan of Care.” The aide care plan indicated a frequency of 4 hours a day for 5 days a week for HHA services. The section titled “Assignment” indicated the HHA was to do the following each visit: obtain temperature, hair care, skin care, mouth/denture care, foot care, nail care, dressing, make the bed, light housekeeping (bedroom, bathroom, kitchen), clean equipment, dust, sweep, vacuum take out the trash, prepare a meal, encourage fluids, feeding, personal care, shower, sponge bath in a chair, check for pressure points, toileting/hygiene, and assist with cane ambulation. The HHA was assigned to shampoo and light laundry weekly. A review of the documents titled “Aide Visit Note-Daily” dated 03/20, 3/22, 3/25, 03/28/, 03/29, 04/01, 04/05, 04/08, 04/12, 04/15, 04/19, 04/22, 04/26, 04/29, 05/03 and 05/13/2024 failed to evidence that HHA 3 had provided any hands-on personal care. Only companionship and housekeeping duties were provided. During an interview on 05/13/2024 at 12:34 PM, when queried regarding the hands-on care for Patient #9 and observed hands-on care from the HHA, RN 4 indicated they had not done a shared visit with the HHA. RN 4 further confirmed if the HHA is not providing hands-on care, they should be on the personal care side, not the home health side. When queried if the HHA had contacted them regarding the HHA care plan on no hands-on care being provided, they stated, “No, never contacted me.”

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 agency failed to ensure the Registered Nurse (RN) completed Home Health Aide Supervisory visits for patients who received skilled services every 14 days for 2 of 2 clinical records reviewed. (Patient: #5 and #8) Findings Include: 1. A policy titled “Home Health Aide Supervision” indicated but was not limited to, “ … Supervisory visits of Home Health Aides shall be according to the following frequency: A. When skilled services are being provided to a client. A Registered Nurse/therapist must make a supervisory visit to the client’s residence no less frequently than every 14 days … ” 2. A review of the clinical record for Patient #5, start of care 10/09/2023, contained a plan of care for the recertification period 04/06/2024 to 06/04/2024. The plan of care contained orders for the following: Skilled Nursing 1 day a week for a medication refill, vital signs, sugar checks every 60 days for recertification and supervisory visits; HHA services for 3 hours a day for 5 days a week for Activities of Daily Living (ADLS) and Instrumental Activities of Daily Living (IADLS). A review of the documents titled “Aide Visit Note-Daily” revealed patient #5 received HHA visits for the following: A. The week of 3/31/2024 to 04/06/2024 HHA 4 completed visits on 04/01, 04/02, 04/03, 04/04, and 04/05/2024. B. The week of 04/07/2024 to 04/13/2024 HHA 3 completed visits on 04/08, 04/09, 04/10, 04/11, and 04/12/2024. C. The week of 04/14/2024 to 04/20/2024 HHA 3 completed visits on 04/15, 04/16, 04/17, 04/18, and 04/19/2024. A review of a signed physician order dated 04/19/2024 indicated a verbal order to place Golden Heart Health Services HHA and SN services on Hold from 04/22/2024 to 05/08/2024 because Patient #5 was going to Florida on vacation with their family. A review of “Supervisory Visit Note” documents revealed HHA supervisory visits documented by RN 2 on 04/10/2024 and RN 4 on 02/01/2024. The record failed to evidence that the RN completed HHA supervisory visits every 14 days. During an interview on 05/10/2024 at 1:33 PM, RN 2 indicated that they completed Patient #5’s HHA supervisory visits every 60 days. RN 2 further revealed that they get confused by the timelines of documentation and services for care provided by an HHA under Medicaid prior authorization versus an Attendant under the Medicaid waiver program.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the Registered Nurse (RN) documentation during supervisory visits accurately reflected the care that was being provided to the patient by the Home Health Aide (HHA) for 2 of 5 active records reviewed. (Patients: #5, and 9) Findings Include: 410 IAC 17-14-1(n) 1. A policy titled “Home Health Aide Supervision” indicated but was not limited to “ …Home health aide supervision ensure that aides furnish care in a safe and effective manner, including but not limited to the following elements: Following the client’s plan of care for completion of tasks assigned to a home health aide by the registered nurse … ” 2. A review of the clinical record for Patient #5, who started care on 05-09-2023, contained agency documents titled “Supervisory Visit Note” dated 04/03/2024 and 11/08/2023. These documents indicated the following: the aide was not present during the visits, reported to work as scheduled, followed the care plan, appeared competent when providing services, used proper body mechanics, adhered to the dress code, adhered to standard precautions, reports client needs/conditions to supervisor in a timely manner, adheres to patient rights, patient/family satisfied with the clinician, good personal grooming habits, and demonstrated open communication. The supervisory visit failed to answer the home health aide's performance accurately, as evidenced by the following: A review of the plan of care for the recertification period of 04/06/2024 to 06/04/2024 revealed orders for discipline and treatment for Skilled Nursing 1 day a week for med refill and HHA 5 hours a day, 5 days a week for Activities of Daily Living (ADLS)/Instrumental Activities of Daily Living (IADLS). Review of an agency document electronically signed by RN 2 and dated 04/04/2024, titled “Aide Plan of Care.” The aide care plan indicated a frequency for 3 hours a day for 5 days a week for HHA services. The section titled “Assignment” indicated the HHA was to do the following each visit: obtain temperature, hair care, skin care, mouth/denture care, foot care, nail care, dressing, make the bed, light housekeeping (bedroom, bathroom, kitchen), clean equipment, take out the trash, prepare the meal, encourage fluids, personal care, shower, sponge bath in a chair, toileting/hygiene, and assist with walker ambulation. The HHA was assigned to shampoo, light housekeeping, bed linen change, dust, sweep, and vacuum weekly. A review of agency documents titled “Supervisory Visit Note” dated 04/03/2024 and 11/08/202 indicated that the aide was not present during the visit, followed the care plan, and demonstrated open communication. A review of the documents titled “Aide Visit Note-Daily” dated 04/08, 04/09, 04/10, 04/11, 04/12, 04/15, 04/16, 04/17, 04/18, and 04/19/2024 failed to evidence any hands-on personal care had been provided by HHA 3. Only companionship, meal prep, and housekeeping duties were provided. During an interview on 05/10/2024 at 11:00 AM, HHA 3 confirmed that Patient #5 does not let them do hands-on care. Patient #5 does all her care herself. When asked if the HHA made the nurse aware, they indicated they made the office scheduler, Admin 1, aware. 3. A review of the clinical record for Patient #9, the start of care 01-03-2024, contained agency documents titled “Supervisory Visit Note” dated 03/27/2024 and 02/29/2024. These documents indicated the following: the aide was not present during the visits, followed the care plan, appeared competent when providing services, used proper body mechanics, adhered to the dress code, adhered to standard precautions, reported client needs/conditions to the supervisor in a timely manner, adheres to patient rights, patient/family satisfied with the clinician, and demonstrated open communication. The supervisory visit failed to answer the home health aide's performance accurately, as evidenced by the following: A review of the plan of care for the recertification period of 05/02/2024 to 06/30/2024 revealed orders for discipline and treatment for a Skilled Nurse for supervisory visits every 60 days and HHA 4 hours a day, 5 days a week to provide assist with personal care and assistance with ADLs. A review of an agency document electronically signed by RN 4 and dated 05/01/2024, titled “Aide Plan of Care.” The aide care plan indicated a frequency for 4 hours a day for 5 days a week for HHA services. The section titled “Assignment” indicated the HHA was to do the following each visit: obtain temperature, hair care, skin care, mouth/denture care, foot care, nail care, dressing, make the bed, light housekeeping (bedroom, bathroom, kitchen), clean equipment, dust, sweep, vacuum take out the trash, prepare the meal, encourage fluids, feeding, personal care, shower, sponge bath in a chair, check for pressure points, toileting/hygiene, and assist with cane ambulation. The HHA was assigned to shampoo and light laundry weekly. A review of the documents titled “Aide Visit Note-Daily” dated 03/20, 3/22, 3/25, 03/28/, 03/29, 04/01, 04/05, 04/08, 04/12, 04/15, 04/19, 04/22, 04/26, 04/29, 05/03 and 05/13/2024 failed to evidence that HHA 3 had provided any hands-on personal care. Only companionship and housekeeping duties were provided. During an interview on 05/13/2024 at 12:34 PM, when queried regarding the hands-on care for Patient #9 and observed hands-on care from the HHA, RN 4 indicated they had not done a shared visit with the HHA. RN 4 further confirmed if the HHA is not providing hands-on care, they should be on the personal care side, not the home health side. When queried if the HHA had contacted them regarding the HHA care plan on no hands-on care being provided, they stated, “No, never contacted me.”

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to have a written agreement or contract with the primary Home Health agency for 2 of 2 patient records reviewed who received care from another entity. (Patient #2, #4) Findings include: 4. During a home visit on 05/13/2024 at 8:55 AM, The Clinical Supervisor indicated that their agency provides aide services for Patient #4, and Entity 2 managed the patient's medication and blood sugar. During an interview on 05/13/2024 at 1:35 PM, the Administrator stated that the agency has no contract with Entity 2 to determine the services being provided. 1. A policy titled "Coordination of Client Services" was provided by the Administrator on 05/10/2024. The policy indicated all disciplines that provide care directly or under arrangement will integrate services. The staff must document coordination activities. 2. During an interview on 05/09/2024 at 3:00 PM, the Clinical Supervisor stated that Entity 1 provides wound care for Patient #2's wounds, and our agency provides aide services. 3. During an interview on 05/10/2024 at 1:19 PM, the Administrator stated that the agency does not have a contract or agreement with Entity 1. She stated that Entity 1 did not have the aide staffing for Patient #2, which was why the agency provided aide services. The Administrator stated that the agency has its plan of care separate from Entity 1. The agency failed to have a written agreement/contract with Entity 1 and failed to work from a single plan of care for Patient #2.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's status at the time of the home visit for 1 of 1 home visit observations with a known wound. (Patient #2) Findings include: 1. A policy titled "Comprehensive Client Assessment" was provided by the Administrator on 05/10/2024. The policy indicated that the comprehensive assessment must accurately reflect the patient's current health status. The comprehensive assessment must address the patient's progress toward goals identified by the patient and agency. 2. During an observation on 05/09/2024 at 3:00 PM, the Clinical Supervisor asked the Certified Nurse Assistant (CNA) 1 to remove three of the six dressings found on Patient #2's bilateral buttocks, sacrum, and mid-lower back. She then asked CNA 1 what stage the wounds were, to which she replied I don't know. CNA told the Clinical Supervisor that the wounds were getting better and that the dressings were due to be changed the next day by Entity 1's nurse. CNA 1 reapplied 2 of the dressings soiled with brown/bloody drainage to the left buttock but did not reapply the gauze dressing to the sacral area. Patient #2 and the Clinical Supervisor stated Entity 1 measures and provide the treatment for the wounds. At that time, the Clinical Supervisor stated the patient didn't like it when the dressings were removed and didn't always allow our agency to assess the areas. The Clinical Supervisor did not provide any education on turning and repositioning or applying clean dressings. 3. A review of Patient #2's record, start of care (SOC) date 03/11/2024, certification period 03/11/2024 to 05/11/2024, included a plan of care and a comprehensive assessment dated 03/11/2024, which failed to evidence coordination between the agency and Entity 1 regarding the care, type of wound treatment/instructions, and progress toward healing for six wounds on the bilateral buttocks, sacral area, and mid-lower back that was observed at the home visit. A review of the non-Oasis document dated 03/14/2024 indicated a wound on the sacral area with no measurements, assessment, staging, or treatment. The non-Oasis indicated the patient refused a wound assessment but did not explain why. The agency failed to educate the patient regarding assessing a wound and failed to indicate if wound care was managed by another Entity. A review of the non-Oasis document dated 04/22/2024 indicated a wound on the sacral area with no measurements, assessment, staging, or treatment. The non-Oasis indicated the patient refused a wound assessment because the dresses had just been changed. The note indicated Entity 1 was providing wound care three times a week. The agency failed to assess a wound(s) and coordinate care with Entity 1 regarding a wound(s). A review of the Braden Scale (a tool used to predict bed sores) dated 03/14/2024 indicated a mild risk for skin breakdown and, on 04/22/2024, an increased moderate risk. The agency failed to prevent an increased risk of skin breakdown and failed to accurately reflect the care provided during the home visit in relation to what was documented in Patient #2's comprehensive assessment and non-Oasis assessment. 4. During an interview on 05/09/2024 at 12:30 PM, the Administrator stated that the nurse should assess the wounds during each nursing visit and coordinate care with the other Entity that provides care. On 05/10/2024 at 8:45 AM, the Administrator was made aware there was no coordination of care with Entity 1 documented. At 2:30 PM the Administrator reviewed Patient #2's chart and stated she would call Entity 1 for a copy of their wound documentation. Upon review of Entity 1's nursing visit notes dated 04/24/2024, 05/01/2024, and 05/08/2024, evidenced that Patient #2 had three stage II wounds to the right buttock and both upper thighs and a stage III wound to the coccyx (tailbone). Entity 1's visit notes did not evidence care coordination with the agency. The agency failed to coordinate wound care with Entity 1. 410 IAC 17-15-1(a)(1)(7)

This visit was initially for a Federal and State Complaint investigation of a Home Health Provider. On 10/19/21, the survey was fully extended and became a Federal Recertification and State Relicensure survey in conjunction with the complaint investigation. The owner/ Governing Body member, alternate administrator, and alternate director of nursing were informed of a full extended survey on 10/19/21 at 9:40 AM. Complaint #: IN00200357603/29868 Substantiated, with findings. Survey Dates: 10/14/2021 to 10/26/2021. The survey exit date was extended to 11/19/2021 due to additional data provided after the exit. Facility #: 013772 CCN/ Provider #: 15K140 Golden Heart Home Health Agency continues to be out of compliance with the Conditions of Participation of 484.50, Patient Rights; 484.55 Comprehensive Assessment of Patients; 484.60 Care Planning, Coordination of Services; 484.65 Quality Assessment and Performance Improvement; 484.80 Home Health Aide Services; 484.105 Organization and Administration of Services, and 484.110 Clinical Records. Based on the Condition-level deficiencies during the November 19, 2021 survey, your home health agency was subject to a fully extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act, on November 19, 2021. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency continues to be precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation program for a period of tow years beginning November 19, 2021 and continuing through November 18, 2023. These deficiencies reflect State Findings cited in accordance with 410 IAC 17. See the State Form for State only deficiencies. Quality Review Completed by Area 3 on 12/17/2021

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure they provided information to the patients, in advance of receiving services, that included written notice of patient rights (See G412), the contact information for the administrator (See G414), and the OASIS (Outcome and Assessment Information Set) Privacy Notice (See G416); and failed to ensure patients were informed in advance of services of their right to participate in care (See G 434), receive all services (See G436); failed to ensure patients were informed of payment from federally funded programs including Medicaid (See G440), received information for the state toll-free hotline number, purpose, and hours of operation (See G444), received the agency's transfer and discharge policies (See G452); and failed to investigate all complaints (See G478), and document all complaint resolutions (See G484). These deficient practices impacted 4 of 4 active patients whose full clinical record was reviewed (1, 3, 4, 6.) The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with Condition of Participation 42 CFR 484.50 Patient Rights. See G412, G414, G416, G434, G436, G440, G444, G452, G478, G484.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients and/or patient representatives received a copy of patient rights and the agency's discharge and transfer policies in advance of furnishing care for 4 of 5 full active records reviewed. (Patients #1, 3, 4, 6) Findings Include: 7. During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, when queried about the patient’s agency admission folder that contained patient rights, as well as the agency's notice of transfer and discharge policies, the patient confirmed not having one. The home health aide, Employee O, also confirmed there was no agency admission folder in the home. During a phone interview on 10/26/21 at 11:55 AM, the caregiver, Person K, confirmed the patient #6 had not received an agency admission folder containing patient rights and responsibilities, and the agency's notice of transfer and discharge policies. 410 IAC 17-12-3(a)1(A)(B) 1. Review of undated agency policy C-380, titled "Home Care Bill of Rights", evidenced "Clients will be informed of their rights as a consumer of home care services ... A designated Registered Nurse/Therapist shall provide the client with a written notice of the "Home Care Bill of Rights" in advance of furnishing care to the client or during the initial evaluation visit before treatment is initiated." Further review of the policy evidenced a signature page which included attestation of receipt, explanation, and understanding of the "Home Care Bill of Rights." 2. Review of a sample admission folder ("red folder"), evidenced a document titled "Patient Handbook." Review of "Section III. Patient Bill of Rights", page 8, indicated "Golden Heart Health Services must provide the patient ... the following information in advance of furnishing care to the patient or during the initial evaluation visit before the initiation or [sic] treatment: a. Written notice of the patient's rights and responsibilities ... and the agency's transfer and discharge policies as set forth in "Transfer and discharge" below." A section found on page 7, titled "Discharge, Transfer and Referral," outlined the agency expectations for discharge and transfer. 3. Review of the clinical record for patient #1, start of care 1/4/21, evidenced a 2-page document titled "Home Health Admission Service Agreement" that indicated "I have been provided verbal and written information on the following information ... Patient Bill of Rights ...." The document was dated 12/31/20, and evidenced an attestation page dated 12/31/20, which was signed as "Verbal." The record failed to evidence the patient received written notice of the patient's rights or the agency's discharge and transfer policies. On 10/20/21 at 2:01 PM, patient #1 stated their admission visit was a 30-minute phone call from the nurse a few days before services started, and they mostly discussed the schedule, then services started "a few days later". Patient #1 stated no in-person visit occurred with an RN (Registered Nurse) for the start of care. The patient denied having been provided a "red folder" start of care packet; denied having received education or written materials in relation to their rights as a home health patient; denied having received a verbal explanation of patient rights and agency discharge/transfer policies; and denied having received the agency's discharge/transfer policies. 4. Review of the clinical record for patient #3, start of care 11/3/20, failed to evidence a "Home Health Admission Service Agreement" or attestation page to document the patient had received written patient rights and agency written discharge/transfer policies. On 10/18/21, at 10:17 AM, the surveyor requested to review all admission paperwork for patient #3. Employee E (scheduling coordinator) stated they were currently unable to find all documents requested and would continue to look. Employee C (alternate director of nursing) stated, "There's stuff we couldn't find so they are still looking for it." On 10/20/21, at 2:01 PM a second request was made to employee B (administrator), who acknowledged the request. The agency failed to provide further documentation for patient #3 prior to the survey exit on 10/26/2021. 5. Review of the clinical record for patient #4, start of care 9/13/19, evidenced a signed "Home Health Admission Service Agreement" dated 9/13/19, which indicated "I have been provided verbal and written information on the following ... Patient Bill of Rights ... Transfer/Discharge Process ...." On 10/21/21, at 10:49 AM, a home visit was conducted with patient #4. When asked if the patient received a red folder (admission folder,) or a written copy of patient rights and agency discharge/transfer policies, the patient stated they did not remember receiving a red folder. When asked if an RN had ever explained the "Patient Bill of Rights" or the agency discharge/transfer policies the patient stated they did not remember the nurse having done so. When asked to review the signature on the “Home Health Admission Service Agreement" patient #4 stated, “I don't remember signing anything like this." 6. On 10/24/21, at 11:31 AM, employee C (Alternate Director) was interviewed concerning the agency's admission process and requirements for the distribution of red admission folders. Employee C stated since around April 2020, all admissions were completed via phone, not in person by an RN. When asked how the patients received the necessary documents, such as the patient rights and agency policies contained in the red admission folder, the employee stated they were supposed to mail, or directly deliver, the red folders to the patients and obtain signed consents and the admission information. Employee C stated the red folders were kept in a pile in the nursing office, with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyor arrived, employee A (agency owner) became worried the patient records didn't contain any admission paperwork or consents. Employee C observed employee A bring in blank documents and instruct certain agency employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission, and create missing admission paperwork for the records requested by the surveyors. Employee C confirmed having observed documents being created, but could not name specific clinical records due to fear of retaliation if employee A discovered employee C was tracking the altered documents.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients were provided correct and updated contact information for the administrator for 4 of 5 full active patients reviewed. (Patients #1, 3, 4, 6) Findings include: 7. During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, when queried about the patient’s agency admission folder and documentation about who the administrator was and whom to report complaints, the patient stated not having one and did not know who to contact at the agency with concerns. During a phone interview on 10/26/21 at 11:55 AM, Person K, a family member confirmed patient #6 had not received the administrator's contact information. 1. Review of undated agency policy C-381, titled "Client/Family Complaint/Grievance Policy" evidenced "All clients admitted to the Agency will be informed of their right to voice grievances to the agency ... Clients will be presented with the Agency ... correct Contact numbers ...." The policy failed to include the administrator's name and contact information in order to receive complaints or grievances. 2. Review of a sample admission folder (red folder), evidenced a patient handbook which indicated employee A (the agency owner) was the agency's administrator and failed to evidence the correct name of the administrator. 3. Review of the clinical record for patient #1, start of care 1/4/21, evidenced a "Home Health Admission Service Agreement" which indicated "I have been provided verbal and written information on the following ... How to file a grievance/complaint with the administrator ...." The document was signed "verbal." The attestation page indicated ... "My signature below indicates I received ... agency contacts [sic the name of the administraor] to voice a concern or complaint as required by Home Health Conditions of Participation” and was signed "verbal" on 12/31/20. The record failed to evidence the patient was provided the administrator's correct name. On 10/20/21 at 2:02 PM, patient #1 indicated not having received an admission folder and did not receive any contact information for the agency administrator. The patient stated having had an admission visit which consisted of a phone call that lasted approximately 30 minutes. The patient stated having discussed mostly scheduling concerns, then agency services started "a few days later." Patient #1 denied having received the name and contact information for the administrator, either written or verbally. 4. Review of the clinical record for patient #3, start of care 11/3/20, failed to evidence the patient had received written notice of the name and contact information for the administrator. On 10/18/21 at 10:17 AM, the surveyor requested to review any/all admission documentation for patient #3. Employee E (scheduling coordinator) stated being unable to find all documents requested and would continue to look. Employee C (alternate director of nursing) stated, "There's stuff we couldn't find so they [sic agency staff] are still looking for it." On 10/20/21, at 2:02 PM a second request was made to employee B (administrator), who acknowledged the request. The agency failed to provide further documentation for patient #3 prior to the survey exit on 10/26/2021. 5. Review of the clinical record for patient #4, start of care 9/13/19, evidenced a "Home Health Admission Service Agreement" which indicated "I have been provided verbal and written information on the following ..." The record failed to evidence the patient received the name and contact information for the administrator. On 10/21/21 at 10:39 AM, a home visit was initiated with patient #4. When queried concerning whether the patient received a red folder upon admission, the patient stated he/she did not remember having received a red folder. When asked to confirm if the patient's signature on the service agreement was the patient's, the patient stated, "I don't remember signing this." 6. On 10/24/21 at 11:31 AM, employee C (alternate director of nursing) was interviewed concerning the agency's admission process and distribution of red admission folders. Employee C stated since around April 2020, all admissions were completed via phone by an RN (Registered Nurse) and were not completed in person by the RN. When asked how the patients received required admission documents contained in the red admission folder, such as the bill of rights, consents, and administrator information, the employee stated they were supposed to mail or directly deliver the red folders to the patients so they could sign consents and get the admission information. Employee C stated the red folders were kept in a pile in the nursing office with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyors arrived, employee A (agency owner) became worried that the patient records didn't contain any admission paperwork. Employee C observed employee A bring in blank documents and instruct various employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission, and create missing admission paperwork for the records requested by the surveyors. Employee C observed documents being created, but could not name specific documents due to fear of retaliation if employee A discovered employee C was tracking the altered documents.

OASIS privacy notice CFR(s): 484.50(a)(1)(iii) (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients received an OASIS (Outcome and Assessment Information Set) Privacy Notice in advance of services for 1 (Patient #4) of 3 patients who received skilled care of a total sample of 7 active patients whose clinical record was reviewed. Findings Include: 1. Review of undated agency policy C-160, titled "Home Care Bill of Rights", evidenced "a. Clients/families will be informed of their right to privacy and confidentiality related to personal health care information data collection and transmission (OASIS)." 2. Review of the clinical record for patient #4, start of care 9/13/19, evidenced patient #4 received skilled nursing services and contained a signed "Home Health Service Agreement" dated 9/13/19, which indicated "I have been provided verbal and written information on the following information ...: The confidentiality of OASIS (Outcome and Assessment Information Set) ...." On 10/21/21 at 10:39 AM, a home visit was initiated with patient #4. When asked if they received a red admission folder when they were admitted, the patient stated they could not remember. When asked to review the signature on the "Home Health Service Agreement" the patient stated, “I don't remember signing anything like this." On 10/24/21 at 11:31 AM, employee C (alternate director of nursing) was interviewed concerning the agency's admission process to include a provision in writing of the OASIS patient privacy rights. Employee C stated since around April 2020, all admissions were completed via phone, not in person by an RN (registered nurse). When asked how the patients received the required documents and information [OASIS privacy notice] contained in the red admission folder, the employee stated agency personnel were supposed to mail or directly deliver the red folders to the patients to deliver required notices and obtain signatures. Employee C stated the red folders were kept in a pile in the nursing office with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyors arrived, employee A (agency owner) became worried that the patient records didn't contain any admission paperwork. Employee C observed employee A bring in blank documents and instruct various employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission and create missing admission paperwork for the records requested by the surveyors. Employee C confirmed having observed agency staff creating documents [to include notices], but could not name specific patients due to fear of retaliation from employee A (agency owner) if it were discovered employee C was tracking the altered documents.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure they obtained the patient's signature confirming that he or she received a copy of the notice of rights and responsibilities for 2 of 5 active patients reviewed. (Patients #1, 3) Findings include: 1, Review of undated agency policy C-380, titled "Home Care Bill of Rights", evidenced "Clients will be informed of their rights as a consumer of home care services ... A designated Registered Nurse/Therapist shall provide the client with a written notice of the "Home Care Bill of Rights" in advance of furnishing care to the client or during the initial evaluation visit before treatment is initiated .... Documentation of the receipt of the "Home Care Bill of Rights" will be maintained in the clinical record." Further review of the policy evidenced a signature page which included attestation of receipt, explanation, and understanding of the "Home Care Bill of Rights." The policy failed to evidence the patient's signature was required. 2. Review of the clinical record for patient #1, start of care 1/4/21, evidenced an unsigned "Home Health Service Agreement" which indicated "I have been provided verbal and written information on the following information ...: Patient Bill of Rights ...." The document was dated 12/31/20 and signed as: "Verbal," Review of an attestation page dated 12/31/20 and signed "Verbal" evidenced "My signature below indicates I received a copy of the Patient Bill of Rights ...." The record failed to evidence the patient's signature for receipt of rights and responsibilities. On 10/20/21 at 2:02 PM, patient #1 confirmed no in-person visit occurred with an RN (Registered Nurse) for the start of care, and they did not receive or sign for a written copy or verbal explanation of patient rights prior to starting services. 3. Review of the clinical record for patient #3, start of care 11/3/20, failed to evidence a patient signature indicating receipt of patient rights. On 10/18/21 at 10:17 AM, the surveyor requested all admission paperwork, or all documents signed at admission. Employee E stated they were currently unable to find those documents. Employee C stated, "There's stuff we couldn't find so they are still looking for it." On 10/20/21 at 2:02 PM the request for signed admission paperwork was repeated and given to employee B. The agency failed to provide admission paperwork or signed documentation that the patient received written and verbal notice of patient rights. 4. On 10/24/21 at 11:31 AM employee C (Alternate director of nursing) was interviewed concerning the agency's admission process and red admission folders. Employee C stated since around April 2020, all admissions were completed via phone, not in person by an RN (registered nurse). When asked how the patients received required documents, such as the patient rights and agency policies contained in the red admission folder, the employee stated they were supposed to mail or directly deliver the red folders to the patients so they could sign consents and get the admission information. Employee C stated the red folders were kept in a pile in the nursing office with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyors arrived, employee A (agency owner) became worried that the patient records didn't contain any admission paperwork. Employee C observed employee A bring in blank documents and instruct various employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission and create missing admission paperwork for the records requested by the surveyors. Employee C confirmed they observed documents being created, but could not name specific ones due to fear of retaliation if employee A discovered employee C was tracking the altered documents.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients participated in and were informed about the care and services to be provided, including but not limited to disciplines, frequency, goals, and outcomes expected in 4 of 5 full active records reviewed. (Patients #1, 3, 4, 6) Findings Include: 6. During a home visit on 10/22/21 from 10:25 AM to 11:10 AM, patient #6 confirmed the agency failed to provide documents informing the patient of the services the patient would receive. Review of the clinical record for patient #6 start of care 2/19/21, failed to evidence patient #6 participated in and was advised, both verbally and in writing, the services the patient #6 would receive. A review of a document titled "Admission Service Agreement Home Health", signed by the patient on 10/17/16, failed to evidence the services patient #6 would receive. A review of an agency document dated 12/14/20, titled, "Discharge Order" evidenced patient #6 was discharged due to a prolonged hospital stay. A review of an agency document dated 1/21/21, titled, "Admit Order" evidenced patient #6 had a new admission order. Patient #6 was readmitted on 2/19/2, therefore the Admission Agreement was from the previous admission. During a phone interview on 10/26/21 at 11:55 AM, the caregiver, Person K confirmed patient #6 had not received a service agreement outlining services to be provided by the home care agency. The caregiver further confirmed the patient and family had not been allowed to participate in care planning. During an interview on 10/22/21 at 3:00 PM when queried about patient #6 consents and the agency folder, Employee A, owner of Golden Heart, stated, “We do not have signed consents for her 2/19/21 admission. That consent is for her 10/17/16 admission. Looks like someone messed up. I know that is bad.” 410 IAC 17-12-3 (b)(2)(D)(i)(AA)&(BB) 410 IAC 17-12-3 (b)(2)(D)(ii)(AA)&(BB) 1. Review of undated agency policy C-580, titled "Plan of Care", evidenced "The client, Therapist, and other agency personnel shall participate in developing the Plan of Care." 2. Review of undated agency policy C-660, titled "Care Plans", evidenced "Each client will have a care plan on file ... This plan is developed with the client and family, as indicated ...." 3. Review of a plan of care for patient #1, 5th certification period of 9/1/21 - 10/30/21, evidenced "Patient participated in Plan of Care development and is in agreement. Patient verbalized understanding of services provided and agrees." The plan of care failed to evidence patient stated goals, agency goals, or progress toward goals, and failed to evidence the patient goals, treatments, and services were discussed and agreed upon, that discharge planning was discussed/updated, or that the patient took an active role in developing the plan of care. A review of the SN (Skilled Nurse) visit note dated 8/31/21, evidenced the care plan was reviewed/revised with patient #1, evidenced the patient's participation in and instructions/teachings to the patient included infection control, universal precautions, home safety, fall precautions/transfer safety, and emergency (911 information). The documentation failed to evidence the content or specifics of plan of care revisions, such as goals, progress, or discharge plans; and failed to evidence how the patient took an active role in participating in the plan of care. On 10/20/21, at 2:02 PM, patient #1 was interviewed concerning participation in and understanding of the plan of care. Patient #1 denied participation in care planning during the recertification phone call on 8/31/21, which had served as the basis for the 5th certification period care plan. The patient stated the nurse called and basically asked how the patient was doing. The patient denied discussing or participating in the plan of care information such as goals, discharge plans, or reviewing the plan of care since beginning services with the agency. 4. Review of the plan of care for patient #3, certification period 8/30/21 - 10/28/21, evidenced "Patient goal is to build strength and increase mobility without falls. Patient strength is to participate in care. The patient participated in Plan of Care development and is in agreement." The plan of care failed to evidence goals, progress, or realistic discharge plans; failed to evidence patient #3 took an active role in the development of the plan of care; and failed to evidence the plan to build strength and increase mobility based on the patient's stated goal. 5. Review of the plan of care for patient #4, certification period 9/2/21 - 10/31/21, evidenced "Patient goal is to actively participate in [the patient's] care. Patient strength is to become more independent with ADL's. (Activities of Daily Living). The patient participated and agrees with POC (Plan of Care)." The plan of care failed to include goals, progress, or realistic discharge plans and failed to evidence the patient took an active role in participating in the plan of care. On 10/21/20, at 10:39 AM, the patient was interviewed during a home visit. When queried as to whether the patient's nurse discussed services, including the patient's plan of care, services, goals, etc., the patient denied any discussions. The patient stated that the nurse did more on this home visit than ever before because the nurse usually comes in, sets up pills in the pillboxes, and leaves. The patient denied receiving vital signs or a physical assessment with any visits and denied discussing the plan of care, goals, progress, or discharge plans.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure patients received all the services ordered in the plan of care for 4 of 5 full active records reviewed. (Patients #1, 3, 4, 6) Findings Include: 9. The clinical record of patient #6, the start of care 2/19/21, was reviewed on 10/22/21. The record contained a plan of care for the recertification period of 8/18/21 to 10/16/21. The plan of care indicated, “…Orders for Discipline and Treatments (Specify Amount/Frequency/Duration): SN (Skilled Nursing) at least q (every) 4 weeks x 9 weeks, to supervise HHA (Home Health Aide. PRN (As Needed) visit x1 as needed to capture re-certification window. SN to assess vital signs and notify the physician: Blood Pressure >180/100 or 20 or 100 or 100 or There were no services provided on the weekend, therefore, the patient failed to receive services 5 days a week. For the week of 9/12/21 to 9/17/21, failed to evidence the aide provide 8 hours of care on 9/13/21 and 9/15/21 and a missed visit on 9/14/21 and 9/17/21. There were no services provided on the weekend, therefore, the patient failed to receive services 5 days a week. For the week of 9/19/21 to 9/25/21, failed to evidence the aide provided 8 hours of care on 9/20/21, 9/21/21, 9/22/21, 9/23/21, and 9/24/21. There were no services provided on the weekend, therefore, the patient failed to receive services 5 days a week. For the week of 9/26/21 to 10/2/21, failed to evidence the aide provided 8 hours of care on 9/27/21, 9/28/21, 9/29/21, and 9/30/21. There was no home health aide care provided to the patient on 10/1/21. There were no services provided on the weekend, therefore, the patient failed to receive services 5 days a week. For the week of 10/3/21 to 10/9/21, failed to evidence the aide provided 8 hours of care on 10/4/21,10/5/21, 10/6/21,10/7/21, and 10/8/21. For the week of 10/10/21 to 10/16/21, failed to evidence the aide provided 8 hours of care on 10/11/21, 10/12/21, 10/24/21, 10/15/21, and a missed visit on 10/13/21. There were no services provided on the weekend, therefore, the patient failed to receive services 5 days a week. During an interview on 10/25/21 at 10:48 AM, Employee H, Registered Nurse (RN) for patient #6, confirmed comprehensive assessment visits were completed per telephone conversations. During an interview on 10/10/26 at 11:55 AM, with patient #6’s caregiver, Person K confirmed, no nurses have been to patient #6's home since we had them stop filling patient #6's medication planner due to their unreliable staffing of nurses. During an interview on 10/22/21 at 1:18 PM, when queried about care, Person J, a family member of patient #6, confirmed they were told patient #6 would get 8 hours daily Monday thru Friday and 4 hours Saturday and that had not happened. Person J further indicated the family has complained to the agency regarding staffing issues because they all work. Patient #6 lives alone in an apartment. They have had to leave work to come to provide care for patient #6 fearful for her safety due to her dementia and falls. 1. Review of undated agency policy C-120, titled "Admission Policy", evidenced "Clients are accepted for treatment in the home on the basis of reasonable criteria and under the expectation that the client's medical, nursing, and social needs can be met adequately by Agency in the client's place of residence." The policy failed to include the criteria and process for the completion of comprehensive assessments/comprehensive recertification assessments via telehealth. 2. Review of undated agency policy C-155, titled "Client Reassessment/Update of Comprehensive Assessment" indicated "The Comprehensive Assessment will be updated and reviewed as often as the client's condition warrants ... Clients are reassessed to determine their response to care ... Each professional discipline will be responsible for reassessing care/services at least every fifty-six to sixty (56-60) days ... Special attention will be paid to client-centered goal setting, clarifying the client's personal goals and his/her expectations ... evaluating processes used and effectiveness of plan established previously. The assessment will identify the problems, needs, and strengths of the client ... " The policy failed to include the criteria and process for the completion of comprehensive assessments/comprehensive recertification assessments via telehealth. 3. Review of undated agency policy C-200, titled "Skilled Nursing Services", evidenced "Skilled nursing services will be provided by a Registered Nurse ... in accordance with a medically approved Plan of Care ...." 4. Review of undated agency policy C-580, titled "Plan of Care", evidenced "The Plan of Care is based on a comprehensive assessment and information provided by the client/family and health team members ... The plan will be consistently reviewed to ensure that client needs are met and will be updated as necessary, but at least every sixty (60) days." The policy failed to include the criteria and process for developing a plan of care using assessments obtained via telehealth. 5. Review of the plan of care for patient #1, certification period 9/1/21 - 10/30/21, indicated orders for skilled nursing 1 time at least every 4 weeks x 9 weeks with 1 PRN (as needed) visit for recertification of services, including a spot-check of the patient's SpO2 (Oxygen Saturation - a non-invasive measure of oxygen in the blood), vital signs, and instruction on home safety, diagnosis management, and medications. The orders also indicated a home health aide (hha) 7-16 hours/day x 5-7 days/week x 9 weeks to assist with ADL's (activities of daily living) and IADL's (instrumental activities of daily living) per hha care plan and included help with bathing, dressing, transfer to the bathroom, meal preparation, light housekeeping, and assistance with safety at night. The record failed to evidence the patient received an appropriate comprehensive assessment prior to developing a plan of care and failed to include orders for telehealth visits. Review of a skilled nurse visit note and comprehensive assessment for patient #1, dated 8/31/21, indicated the visit was completed via telehealth and failed to evidence the patient received an appropriate in-person comprehensive physical re-assessment as ordered on the plan of care. Review of the aide care plan, effective 9/1/21, indicated the aide was assigned the following tasks: temperature, prepare meal, check for pressure points, toileting/hygiene, and assist with wheelchair and BSC (bedside commode) each visit; hair care, shampoo, skin care, dressing, light housekeeping, trash removal each visit per patient request; light laundry, bed linen change, clean equipment, dust, sweep, vacuum weekly per patient request. Review of the visit notes for 9/19/21 - 10/16/21 failed to evidence patient #4's temperature was checked each visit; failed to evidence the patient had a meal prepared each visit; failed to evidence the patient received assistance with a wheelchair and/or BSC each visit; failed to evidence the patient was checked for pressure points with each visit; and failed to evidence the patient received the frequency and/or duration of home health aide services as ordered in the plan of care. 6. Review of the plan of care for patient #3, certification period 8/30/21 - 10/28/21, evidenced orders for skilled nursing at least every 4 weeks with 1 PRN visit as needed "to capture recertification window." The skilled nurse was to assess vital signs and notify physician of the following: Blood pressure >180/100 or 20 or 100 or 100 or Review of the clinical record evidenced a document titled "Assessment Details", dated 8/31/21, which indicated the information was obtained via telehealth one day after the new certification period began and outside of the 5-day window for completion of a re-assessment comprehensive assessment. The record failed to evidence the patient received an in-person comprehensive re-assessment as ordered, and failed to evidence the patient received vital signs and SpO2 as ordered on the plan of care. Review of the skilled nurse visit note, dated 9/27/21, evidenced the visit was completed via telehealth and failed to include vital signs and SpO2, and failed to evidence the patient received a full comprehensive physical assessment as ordered. Review of the Home Health Aide care plan, effective 8/31/21, evidenced the aide tasks of obtaining a temperature, assisting with a walker, and encouraging fluids each visit; evidenced the aide should perform hair care, skin care, mouth care, foot care, nail care, dressing, light laundry, make bed, light housekeeping, empty the trash, perform personal care, and provide a shower and sponge bath each visit, per request; and evidenced the aide should provide a shampoo, linen change, dust, sweep, and vacuum weekly per patient request. Review of the record for certification period 8/30/21 - 10/12/21, evidenced the following hha visit notes were submitted and marked as complete in the electronic record: 9/24/21 from 10:30 AM - 2:30 PM and 7:30 PM - 11:30 PM (8 hours.) These visit notes failed to evidence a patient temperature, assistance with the patient's wheelchair, and encouragment of fluids; 9/28/21 from 6:30 PM - 8:30 PM (2 hours) and failed to evidence a temperature, assist with a wheelchair, and encouragement of fluids; 10/4/21 from 1 PM - 7:30 PM (6.5 hours), and failed to evidence any tasks were provided; 10/5/21, 10/6/21, 10/8/21, 10/9/21, and 10/11/21 from 10:30 AM - 7:30 PM (9 hours each) and failed to evidence any tasks were provided. No further visit notes were available for 8/30/21 - 10/28/21 for visits marked as complete in the electronic record. (See interview below) The record failed to evidence the patient received an in-person comprehensive re-assessment as ordered; failed to evidence the patient received the home health aide services ordered on the medical plan of care and defined on the hha plan of care; failed to evidence orders for services that could be provided via telehealth; failed to evidence the patient received vital signs and SpO2 as ordered; and failed to evidence patient #3 received the frequency and/or duration of home health aide services as ordered. 7. Review of a plan of care for patient #4, certification period 9/2/21 - 10/31/21, evidenced skilled nursing 1x every other week for 9 weeks to set up medication and provide medication management, obtain vital signs, and notify the physician for BP [blood pressure] >180/100 or 20 or 100 or 100 or Review of the "Skilled Nursing Visit Note" dated 10/7/21, failed to evidence vital signs and SpO2 were obtained and failed to evidence the patient received an in-person comprehensive assessment as ordered. Review of a recertification assessment titled "OASIS (Outcome and Assessment Information Set) Assessment Details" dated 9/9/21, indicated "Patient would benefit from skilled nursing 1x every 2 weeks x 9 weeks to help with medication set up/management and monitor for medication compliance and poor vision." The document failed to evidence the patient was monitored for poor vision. On 10/19/21 at 2:30 PM, patient #4 was interviewed via phone concerning a possible home visit with the surveyor. The patient stated he/she had had to call after hours for help with medication in the past because the nurse didn't always show up as scheduled. The patient stated he/she wanted a visit at 11 AM. The surveyor reviewed the patient's previous schedule which showed all visits at 8 AM - 9 AM. Patient #4 stated that was way too early because he/she doesn't get up until 9 AM. The patient stated ... 11 AM is the regular time for my visits. "I never know who's coming, or when." 8. On 10/18/21 at 9 AM, employee C (alternate director of nursing) was interviewed with employee A (agency owner), employee B (administrator), employee D (director of nursing) present, and employee E (scheduling coordinator) were present. When queried as to why the agency completed all comprehensive assessments via telehealth, employee C stated there was a blanket waiver that said assessment visits could be done via telehealth. When queried as to the difference between the initial and comprehensive assessment, employee C stated, "The initial is the comprehensive. There's no difference." Employee C also stated the clinician does not call the physician to review findings and obtain orders for services. Employee C stated, "We just print the verbal order in Alora for a recertification." When queried concerning the agency's responsibility for recertification, the content of the comprehensive assessment, and the medical and hha plans of care, employee C stated, "There's the 5-day window. You have 5 days before or 5 days after. It doesn't have to be exact." Employee C also stated, "We create the 485 (medical plan of care) and aide plan of care and fax it to the MD." Employee C stated the nurse does not call the physician's office for specific orders for services. The patient is questioned over the phone, and they obtain a medication list from the physician's office. Employee C stated, "Other than the med (medication) fills I told you about, I've never even seen a patient in person. And I wasn't taught to even do vitals on the med fill patients." When queried concerning frequency and duration of service delivery, employee C stated, "CICOA (the Area Agency on Aging and Disability) tells us, and the patient also tells us." When queried concerning the use and frequency of "per patient request" for tasks on the aide care plan, employee C stated, "It just depends on whatever the patient needs." Employee A stated, "If they don't tell us, we just start suggesting - you kind of have to suggest things to do." When queried concerning the reconciliation of aide visit notes for patients #1 and 3, due to missing notes for visits confirmed and closed in the Alora schedule, employee E stated they'd "talked to" the aides for patients #1 and 3 about missing paperwork. Employees A, B, C, and E confirmed no further reports, audits, or documentation was available. On 10/19/21 at 10:22 AM, employee C and employee E were interviewed. When queried concerning the process for receiving the aide visit notes, employee E stated, "I check daily for them to be completed. And I do a big one twice a week. I have a notebook where I'm keeping track. I put a note in my notebook if I call someone." When queried whether the missing visit note for patients #1 and #3 had been turned in, employee E indicated they had not. On 10/22/21 at 11:37 AM, employee H, RN (Registered Nurse) was interviewed via phone. Employee H stated patient #6 had concerns about services because no one was coming for care visits, and the patient wasn't happy. Employee H indicated while processing the recertification for patient #6 and had assured the patient there would be staff available. During the skilled nursing visit on 10-22-21, employee H was instructed by the agency that there would be no hha available that day. Employee H had no further information.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to advise the patient and/or patient representative orally and in writing in advance of starting services of the extent to which planned services would be covered by Medicaid or any other federally funded program and the expected out-of-pocket cost to the patient in 4 of 5 full active patients reviewed. (Patients #1, 3, 4, 6) Findings Include: 6. During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, the patient stated not having a start of care folder when queried about the patient’s agency start of care which contained the agency service agreement and cost of services. The home health aide, Employee O also confirmed there was no agency folder in the home. During a phone interview on 10/10/26/21 at 11:55 AM, the caregiver, Person K confirmed patient #6 had not received a copy of the service agreement that contained the extent to which Medicaid or other federally funded programs would cover any possible charge to the client that is not covered. During an interview on 10/22/21 at 3:00 PM, when queried about patient #6 service agreement, Employee A, owner of Golden Heart, stated, not having signed service agreements for the patient's 2/19/21 admission and stated "That consent is for her 10/17/16 admission. Looks like someone messed up. I know that is bad.” 1. Review of undated agency policy C-160, titled “Service Agreement” evidenced “A Service Agreement shall be developed with all clients upon admission before care is provided. The service agreement will identify the services to be provided, disciplines providing care, charges, and expected sources of reimbursement for services. The client will be informed of their liability for payment." 2. Review of the “Home Health Admission Service Agreement” for patient #1, start of care 1/4/21, evidenced Medicaid was checked. The anticipated payment and patient responsibility sections were blank. The "Home Health Admission Service Agreement" was unsigned, and was dated 12/31/20. The document failed to evidence the patient was notified in writing of the extent to which planned services would be covered by Medicaid or any other Federally funded program and the patient’s out-of-pocket costs and services to be provided. On 10/20/21 at 2:02 PM, patient #1 was interviewed via phone and stated they were never informed of the information listed on the service agreement and denied receiving a red folder or any admission information prior to or since the start of care. Patient #1 denied consenting verbally that they had received the information verbally or in writing. 3. Review of the clinical record for patient #3, start of care 11/3/20, failed to evidence a service agreement and failed to evidence the patient was advised in writing of the extent to which planned services would be covered by Medicaid or any other federally funded program, and the patient’s out of pocket costs. 4. Review of the “Home Health Admission Service Agreement” for patient #4, start of care 9/13/19, evidenced services and planned frequency of “Skilled Nurse 1 x/ week x 9 weeks and every 56-60 days for recertification pending Medicaid PA approval." "Medicaid" was checked under liability for payment. The anticipated payment was "0" and the patient responsibility was blank. The document failed to evidence the patient was notified of the extent to which services would be covered by Medicaid and the patient’s out-of-pocket costs. On 10/21/21 at 10:39 AM, a home visit was initiated with patient #4, who stated they did not remember receiving a red folder or other types of admission paperwork that included written financial and/or service information. The patient was given the signed service agreement for review and stated, “I don’t remember signing this.” 5. On 10/24/21 at 11:31 AM employee C (alternate director of nursing) was interviewed concerning the agency's admission process and red admission folders. Employee C stated since around April 2020, all admissions were completed via phone, not in person by an RN (registered nurse). When asked how the patients received required documents, such as the service agreement which includes the planned services that would be covered by Medicaid or any other Federally funded program and any charges that may not be covered by Medicaid or the Federally funded programs, the employee stated they were supposed to mail or directly deliver the red folders to the patients so they could sign consents and get the admission information. Employee C stated the red folders were kept in a pile in the nursing office with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyors arrived, employee A (agency owner) became worried that the patient records didn't contain any admission paperwork. Employee C observed employee A bring in blank documents and instruct various employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission and create missing admission paperwork for the records requested by the surveyors. Employee C confirmed they observed documents being created, but could not name specific ones due to fear of retaliation if employee A discovered employee C was tracking the altered documents.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to provide the patients with the toll-free home health telephone hotline information and purpose for 4 of 7 active patients reviewed. (Patients #1, 3, 4, 6) Findings Include: 7. During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, when queried about the patient’s agency folder that should contain the Indiana Department of Health (IDOH) toll-free number for the complaint line, the patient stated not having one. The home health aid, Employee O also confirmed there was no agency folder that contained the IDOH toll-free number for complaints in the home. When queried patient #6 about what to do if she had a complaint confirmed not knowing how to reach the Indiana State hotline. During a phone interview on 10/10/26/21 at 11:55 AM, the caregiver, Person J confirmed the patient #6 has not received the state hotline toll-free number nor the hours of operation. The caregiver further indicated she did not know how to reach the Indiana State hotline for complaints. IAC 17-12-3(b)(2)(C) 1. Review of the agency admission folder (red folder) evidenced an undated document titled "Patient Handbook", which indicated "... you may contact the State's Home Care Hotline which receives complaints or questions about local home care agencies. Their hours are 8:15 a.m. - 4:45 p.m. Monday to Friday and they may be reached at 1.800.246.8909. An answering machine is available and will record your call after 4:30 p.m." 2. Review of undated agency policy C-380, titled "Home Care Bill of Rights" evidenced "The client/caregiver shall be advised orally and in writing of their right to voice grievances and the method of contacting the agency if dissatisfied. This shall include information about the Home Health Agency Hotline (established by the state), including its hours of operation and that the purpose of the hotline is to receive questions or complaints about local home health agencies." The document evidenced the state toll-free hotline number and hours of operation from 8:15 AM - 4:45 PM, but failed to include the toll-free number was available 24h/day. 3. Review of undated agency policy C-381, titled "Client/Family Complaint/Grievance Policy" evidenced "All clients admitted to the Agency will be informed of their right to voice grievances to the agency ... Clients will be presented with a copy of the Home Care Bill of Rights and the Agency and State Contact numbers for voicing a complaint ... clients/families not satisfied ... may contact an appropriate quality review source at the Department of Health or Specific Health Plan." The policy failed to evidence the state toll-free hotline number and information. 4. Review of undated agency policy C-422, titled "Section 504 Grievance Procedures" failed to evidence the state's toll-free hotline number and information. 5. Review of the clinical record for patient #1, start of care 1/4/21, evidenced a document titled "Home Health Admission Service Agreement" which indicated "I have been provided verbal and written information on the following information ... the state hotline number." The document failed to evidence the patient's signature, receipt of an admission folder, receipt of the patient handbook, or the state hotline number. On 10/20/21 at 2:02 PM, patient #1 stated the RN (Registered Nurse) had completed the patient's admission via phone. Patient #1 stated their admission visit occurred via phone and denied receiving an agency admission folder or handbook. The patient stated they were unaware of the state toll-free number for complaints. 4. Review of the clinical record for patient #3, start of care 11/3/20, failed to evidence the patient received written notice of the state toll-free hotline number and information. On 10/18/21 at 10:17 AM, the surveyor requested all admission paperwork, or all documents signed at admission. Employee E stated they were currently unable to find those documents. Employee C stated, "There's stuff we couldn't find so they are still looking for it." On 10/20/21 at 2:01 PM the request for signed admission paperwork was repeated and given to employee B. The agency failed to provide admission paperwork, including proof the patient received the state toll-free information, prior to the survey exit. 5. Review of the clinical record for patient #4, start of care 9/13/19, evidenced a signed "Home Health Admission Service Agreement" dated 9/13/19. The "Service Agreement indicated "I have been provided verbal and written information on the following information ... the state hotline number." The document failed to evidence the state hotline number. On 10/21/21 at 10:39 AM, patient #4 was interviewed during a home visit. When asked if they had a red agency folder or any documents with the toll-free hotline information, the patient stated they did not know there was a toll-free number for complaints and stated they did not remember receiving a red folder, or the equivalent, upon admission. When asked to review the signature on the "Home Health Admission Service Agreement" the patient stated, “I don't remember signing anything like this." 6. On 10/24/21 at 11:31 AM employee C (alternate director of nursing) was interviewed concerning the agency's admission process and red admission folders. Employee C stated since around April 2020, all admissions were completed via phone, not in person by an RN (registered nurse). When asked how the patients received required documents, such as the required information of the state's complaint line, toll-free number, and hours of operation that is contained in the red admission folder, the employee stated they were supposed to mail or directly deliver the red folders to the patients so they could sign consents and get the admission information. Employee C stated the red folders were kept in a pile in the nursing office with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyors arrived, employee A (agency owner) became worried that the patient records didn't contain any admission paperwork. Employee C observed employee A bring in blank documents and instruct various employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission and create missing admission paperwork for the records requested by the surveyors. Employee C confirmed they observed documents being created, but could not name specific ones due to fear of retaliation if employee A discovered employee C was tracking the altered documents.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients were informed in writing of the agency's policies for transfer and discharge in 4 of 5 full active patients reviewed. (Patients #1, 3, 4, 6) Findings Include: 8. During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, when queried, the patient stated not having an agency start of care folder. A review of the clinical record for patient #6, the start of care date 2/19/21, failed to evidence the patient was informed verbally and in writing of the agency's discharge and transfer policies. During a phone interview on 10/10/26/21 at 11:55 AM, the caregiver, Person J confirmed the patient #6 had not received a folder containing transfer and discharge policies. 1. Review of undated agency policy C-500, titled "Client Discharge Process", evidenced "Discharge Planning is initiated for every home care client at the time of the client's admission for home care." 2. Review of undated agency policy C-380, titled "Statement of Rights", evidenced an attestation signature page which indicated, "I have been provided with a copy of the Home Care Bill of Rights. I have read the Bill of Rights or had it explained to me. I understand the Bill of Rights and have had a chance to have all of my questions answered." 3. Review of the agency admission folder evidenced a document titled "Patient Handbook" which included "Section III. Patient Rights and Responsibilities (Patient Bill of Rights)", and indicated "Golden Heart Health Services must provide the patient ... the agency's transfer and discharge policies as set forth in "Transfer and discharge" below." Continued review of the transfer and discharge section of the handbook evidenced detailed reasons for which the agency may transfer or discharge patients, and included "Heal at Home must arrange a safe and appropriate transfer ... and the agency and physician ... agree that the patient no longer needs Heal at Home's services ... " The Bill of Rights failed to list the correct agency's discharge and transfer policy(s). 4. Review of the clinical record for patient #1, start of care 1/4/21, evidenced a "Home Health Admission Service Agreement" which stated, "I have been provided verbal and written information on the following information in a language and manner I understand." Check-marked items included: "Patient Bill of Rights and Transfer/Discharge." The document was dated 12/31/20 and failed to evidence the patient's signature. Review of the attestation page, dated 12/31/20, evidenced "My signature below indicates I received a copy of the Patient Bill of Rights, Transfer/Discharge Policy ...." but failed to evidence the patient's signature. On 10/20/21 at 2:01 PM, patient #1 stated they'd never seen an agency RN (Registered Nurse) in person for the start of care or further recertification visits, as all certifications were completed via phone. The patient denied receiving a folder or written admission information and stated no information was reviewed over the phone. The patient stated their admission visit occurred via a phone call that lasted about 30 minutes, then services started "a few days later." 5. Review of the clinical record for patient #4, start of care 9/13/19, evidenced a signed document titled "Home Health Admission Service Agreement" dated 9/13/19. On 10/21/21 at 11:16 AM, patient #4 was interviewed during a home visit. When asked if they had a red agency folder or had ever received the patient rights and transfer/discharge policies in writing, the patient stated they did not remember receiving a folder before or at the time of admission. When asked to review the signature on the “Acknowledgement of Information”, the patient stated, “I don't remember signing anything like this." 6. On 10/18/21 at 10:17 AM, the surveyor requested all admission paperwork, or all documents signed at admission. Employee E stated they were currently unable to find those documents. Employee C stated, "There's stuff we couldn't find so they are still looking for it." On 10/20/21 at 2:01 PM the request for signed admission paperwork was repeated and given to employee B, who stated she would look for it. The agency failed to provide admission paperwork, including proof the patient received written and verbal notice of patient rights and/or transfer/discharge policies, prior to the survey exit. 7. On 10/24/21 at 11:31 AM employee C (Alternate Director) was interviewed concerning the agency's admission process and red admission folders. Employee C stated since around April 2020, all admissions were completed via phone, not in person by an RN (registered nurse). When asked how the patients received required documents, such as the patient rights and agency policies that are contained in the red admission folder, the employee stated they were supposed to mail or directly deliver the red folders to the patients so they could sign consents and get the admission information. Employee C stated the red folders were kept in a pile in the nursing office with the intention of mailing them to the patients, but that never happened. Employee C stated after the surveyors arrived, employee A (agency owner) became worried that the patient records didn't contain any admission paperwork. Employee C observed employee A bring in blank documents and instruct various employees to identify the patient's signature and date of admission, then identify from the list of signatures on file the signature of the nurse completing that admission and create missing admission paperwork for the records requested by the surveyors. Employee C confirmed they observed documents being created, but could not name specific ones due to fear of retaliation if employee A discovered employee C was tracking the altered documents.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review, and interview the agency failed to document the existence and resolution of complaints made by the patient and/or patient representative in 3 of 3 records reviewed with complaints. (Patients #1, 3, 6). Findings Include: 6. During an interview on 10/22/21 at 12:43 PM, Person K, a family member of patient #6, stated, “We have had several calls with Golden Heart with our complaints of the staffing issues and staff not trained.” During an interview on 10/22/21 at 1:18 PM, Person J, a family member of patient #6, stated, “We stopped having them set up [sic patient #6's] medications because we could not rely on them. The nurses do not come to [sic patient #6’s] home. The home health aides we complained to the office about [sic patient #6] hours not being staffed and unreliable.” A review of agency documents titled, “Complaint Logs” dated January 2021 to October 2021, failed to evidence documented complaints made to the agency from patient #6 and the patient’s caregivers/ family members. During an interview on 10/25/21 at 11:21 AM, when queried about patient #6 and family complaint forms the owner confirmed there was no evidence of complaints in the patient file or the complaint book logs. IAC 17-2-3(c)(2) 1. Review of un-dated agency policy C-381, titled "Client/Family Complaint/Grievance Policy" evidenced a complaint was defined as " ...any expression of dissatisfaction by a client/family regarding care or services that can be addressed at the time of complaint by staff present ... A grievance is any formal or informal written or verbal expression of dissatisfaction with care or service that is expressed by the client/family that is not solved at that time by staff present. A written complaint is always considered a grievance ..." The policy indicated client complaints would be "documented on a client complaint form and filed with the complaint log in an administrative file." Immediately following, the policy stated that "grievances ... will be documented on the grievance form ... and forwarded as soon as possible to the appropriate director or to the management team ... Grievances will be addressed by the department director or his/her designee and response made to the complainant within seven (7) calendar days of receipt ... all persons with a grievance will receive a written notice of the investigators [sic] review. The policy failed to include the process for handling complaints, including documentation of the complaint resolution. 2. Review of the undated "Patient Handbook" evidenced "The patient has the right to: ... Make complaints to the home health agency regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the home health agency. The home health agency will document the existence of the complaint and the resolution of the complaint. 3. Review of the clinical record for patient #1, start of care 1/4/21, evidenced a communication note titled "Complaint - caregiver no-show", dated 1/25/21 which indicated the patient called the on call line twice due to a caregiver no show on 1/23 - 124/21 night shift, and received no answer or call back. The patient also requested to have different caregivers on the weekend for backup. Patient #4 was given "the direct line and also the DON (Director of Nursing) number to call so that we can have staff ... and avoid this again." The patient was informed the caregiver stated the patient's visit was not on the caregiver's schedule. The communication note failed to indicate resolution for the missed visit, including whether the hours and care were rescheduled, how the agency would ensure staffing. and how giving the "direct line and also the DON number" would ensure that the agency had staff. Review of a communication note dated 3/15/21, titled "complaint - staffing" evidenced the patient would like a phone call if there was no weekend staffing. The note indicated "I verbalized scheduling and Administration of complaint and concern. I followed up with caregiver and TH [sic] scheduler of problem and educated that pt [patient] needs to be called by Wednesday if no staff available for the weekend." The note failed to evidence the actual complaint, including whether the patient had no staffing on previous weekends which prompted the call, clarification for the meaning of "verbalized scheduling and Administration of complaint"; and failed to include communication with patient #1 concerning the resolution of the complaint. Review of a communication note titled "complaint: staffing" evidenced "Followed up with pt (patient) that we are looking for caregiver for Sat (Saturday) night and called Cicoa [CICOA - the Area Agency on Aging and Disability case management agency for the patient's waiver services] to update CM [Care Manager] of need for another possible company for pt in the future if we are unable to staff pt in future weekends." The note failed to evidence documentation of the complaint or failed to reference which previous complaint was being followed. Review of a communication note dated 3/18/21, titled "Complaint: staffing follow up" evidenced "Follow up with pt and staffing on schedule for 3/20 night and 3/21 night. Pt please with information. The note failed to evidence the specific complaint or resolution for that complaint. Review of a communication note dated 4/20/21 titled "Complaint: complain [sic]" evidenced "[Name of patient #1] called to complain about the office not calling him when staff is not available. [He/she] stated [he/she] is unable to move or go to the bathroom without help. Talked with [Name of patient #1] and Administration along with scheduling. Caregiver verbal warning for late call in. Talking with pt to help neighbors join staff so [he/she] will be able to receive help." The documentation failed to evidence resolution related to the complaint of agency failing to call when staff was not available. 4. Review of the clinical record for patient #3, dated 3/24/21, evidenced a communication note titled "Complaint: Complaint Investigation", which indicated "Administration aware that Pt and other company [sic] claim Caregiver has not shown up for visits. Administration stated she will do a SUP [supervisory] visit today to verify if caregiver at home." No further resolution was provided. Review of a communication note dated "3/26/21 titled "Complaint: complaint update" evidenced "Administrator was notified by the social worker on Tuesday 3/23/21. Administrator went to client home on 3/25/21to verify if caregiver was there during the timeframe scheduled for. Caregiver was not there. Client confirm [sic] that caregiver has not been there but once during the last two months. Administrator called caregiver at the client home. caregiver [sic] stated she was at home with her daughter. Caregiver did not confirm or deny being with the client during shifts scheduled for. Caregiver immediately terminated. Billing was voided for past two months. Client is being restaffed ASAP. (as Soon As Possible)" The record failed to evidence the resolution for the client's immediate staffing needs and failed to evidence the agency contacted the patient concerning the resolution. 5. Review of the complaint log for 2021 evidenced a document titled "Golden Heart Health Services, LLC Complaint Log 2021", which evidenced checkmark for Jan - May and "LOG IN ALORA (pt LOG)". The document provided columns for Initial/MR# (medical record number), date, brief description, cause, and resolution. The columns were blank. Further review evidenced complaints from patient #1 identical to the above-described complaints and failed to follow the agency's policy for documenting complaints.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessments were completed in-person to achieve accurate and complete information and were accurately and completely filled out; accurately reflected the patient's past medical history and current health, psychosocial, functional, and cognitive status, accurately included the patient's medical, nursing, rehabilitative, social, and discharge planning needs; accurately included the patient's strengths, goals, and care preferences; accurately reflected the patient's needs, included an appropriate review/reconciliation of all prescription and over the counter medications; and failed to ensure comprehensive assessments were completed within the last 5 days of the certification period, within 48 hours of return home from hospital admission, and at discharge in 8 of 9 patient sampled records reviewed (Patients 1, 2, 3, 4, 6, 7, 8, 9). These deficient practices have the potential to affect all patients who are currently receiving home health services from this provider. The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with the Condition of Participation 42 CFR 484.55 Comprehensive Assessment. Findings include: 1. The agency failed to ensure that all patients received an in-person complete and accurate comprehensive assessment which would include the patients' current health status, past/ current medical history, accurate psychosocial status and functional capacity, and accurate cognitive status. (See G528) 2. The agency failed to ensure a complete and accurate assessment of the patient's strengths, goals, and care preferences. (See G530) 3. The agency failed to ensure a complete and accurate assessment of the patient's medical, nursing, rehabilitative, social, and discharge planning needs. (See G534) 4. The agency failed to ensure a registered nurse reconciled all medications, including prescription and over-the-counter medications. (G536) 5. The agency failed to ensure the comprehensive assessment was completed within the last 5 days of the certification period, including day 60. (See G546) 6. The agency failed to ensure an assessment was completed within 48 hours of the patient's return from a hospital admission. (See G548) 7. The agency failed to ensure an assessment was completed at discharge. (See G550)

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that all patients received an in-person complete and accurate comprehensive assessment that included the patients' current health status, past/ current medical history, accurate psychosocial status and functional capacity, and accurate cognitive status in 8 of 9 patient records reviewed. (Patients #1, 2, 3, 4, 6, 7, 8, and 9) Findings Include: 1. Review of undated agency policy C-155, titled "Client Reassessment/Update of Comprehensive Assessment" evidenced " ... Assessment will include OASIS (Outcome and Assessment Information Set) data collection for all ... Medicaid skilled clients. Clients who are not receiving skilled services under the ... Medicaid program will be assessed using the OASIS tool or an alternative form identified by the agency ... The assessment will identify the problems, needs, and strengths of the client ... Description of any applicable strengths the client has including physical, psychosocial, and or spiritual resources ... Progress toward goals since previous assessment ...." 2. Per the CMS Blanket Waivers, only the initial assessments are waived to allow home health agencies to perform Medicare-covered initial assessments remotely or by record review, therefore Comprehensive Assessments are not waived to be completed remotely. 3. Review of the clinical record for patient #1, for the certification period of 9/1/21 - 10/30/21, evidenced a skilled nurse visit note dated 8/27/21, which was used in place of a comprehensive recertification assessment, and indicated the visit was completed via telehealth. The record failed to evidence the patient's complete current and past health, psychosocial, functional, and mental status. On 10/20/21 at 2:01 PM, the patient was interviewed concerning services received. Patient #1 denied speaking with the clinician concerning the plan of care and stated they have never met a clinician in person for an assessment and development of the plan of care because all communication was via phone. 4. The clinical record of patient #2 was reviewed for the certification period of 6/30/21 to 8/28/21 and contained a document titled “Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 7/2/21. Several sections of this assessment indicated “telehealth” or “telehealth visit.” 5. The clinical record of patient #3 was reviewed for the certification period of 8/30/21 - 10/28/21 and contained a document titled “Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 8/31/21. Several sections of this assessment indicated “via telehealth visit.” 6. The clinical record for patient #4 was reviewed for the certification period of 9/2/21 - 10/31/21 and contained a document titled “OASIS Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 9/9/21. Several sections of this assessment indicated “via telehealth visit.” 7. The clinical record for Patient #6 was reviewed for the certification period of 8/18/21 - 10/16/21 contained a resumption of care comprehensive assessment dated 9/17/21, which on page 23 of 23, the general notes indicated “ROC [resumption of care] completed via telehealth visit with patient”. Further review of the clinical record for the certification period of 10/17/21 - 12/15/21 contained a document titled “Assessment Details” dated 10/15/21, indicated the document was a recertification assessment however on page 22 of 22, indicated in the General Notes "ROC [resumption of care] completed via telehealth visit with patient'. The assessment failed to evidence a complete and accurate assessment, and indicated throughout different sections that it was a “Telehealth visit”. During an interview on 10/26/21 at 11:55 AM, Person J, a family member stated, “No nurse has seen [Name of Patient #6] since the pandemic. We stopped them from setting up [Name of Patient #6] medications because we could not rely on them. The nurse called once said she had to speak to us for [Name of Patient #6] to continue services. I dialed in [Name of Patient #6] and [sic the nurse] just asked how [Name of Patient #6] was feeling. This happened on Friday, the 15th of this month.” 8. The clinical record for Patient #7 was reviewed for the certification of 8/22/21 to 10/20/21 and contained a skilled nursing visit note dated 8/17/21 indicating the visit was a “Telehealth visit”. Different body system sections throughout the assessment were incomplete. The general notes indicated this document was for a recertification visit that was completed via telehealth. 9. The clinical record of patient #8 was reviewed for the certification period of 10/12/21 - 12/10/21 and contained a document titled “OASIS Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 10/11/21. 10. The clinical record of patient #9 was reviewed for the certification period of 9/22/21 - 11/20/21 and contained a document titled “OASIS Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. The general notes section indicated “Recert Telehealth completed at this time”. This document indicated it was for recertification that was completed on 9/21/21. 11. During an interview on 10/18/21 at 9 AM, when queried as to the difference between an initial and a comprehensive assessment. Employee C (alternate director of nursing) stated, "The initial is the comprehensive." Employee C was queried as to the agency process for recertification and stated "We go by Alora (the agency's electronic medical record)." Employee C stated the comprehensive assessments are completed over the telephone, not in person, and the clinician initially documents on a skilled nurse visit note, then transfers the information to an OASIS (Outcome Assessment and Information Set) form, then use the information to complete the plan of care/485.

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients received a detailed comprehensive assessment that included patient strengths, patient-specific care preferences, and goals that were patient-specific and measurable for 5 of 7 active patients reviewed. (Patients #1, 3, 4, 8, 9) Findings Include: 1. Review of undated agency policy C-155, titled "Client Reassessment/Update of Comprehensive Assessment" evidenced "... Assessment will include OASIS (Outcome and Assessment Information Set) data collection for all ... Medicaid skilled clients. Clients who are not receiving skilled services under the ... Medicaid program will be assessed using the OASIS tool or an alternative form identified by the agency ... The assessment will identify the problems, needs, and strengths of the client ... assessments include consideration of the following: Specific individualized client needs pertinent to the care or service being provided. Description of any applicable strength the client has including physical, psychosocial, and or spiritual resources ... Progress toward goals since previous assessment ...." 2. Review of the clinical record for patient #1, for the certification period 9/1/21 - 10/30/21, evidenced a skilled nurse visit note dated 8/27/21, used in place of a comprehensive recertification assessment, which indicated the visit was completed via telehealth. The record failed to evidence the patient received an in-person recertification assessment that included patient strengths and care preferences and evidenced patient-specific, measurable goals or progress toward previous goals. 3. Review of the clinical record for patient #3, for the certification period of 8/30/21 - 10/28/21, failed to evidence the patient received a comprehensive recertification assessment that included patient strengths and care preferences and evidenced patient-specific, measurable goals and outcomes. 4. Review of the clinical record for patient #4, for certification period of 9/2/21 - 10/31/21, failed to evidence the patient received a comprehensive recertification assessment that included patient strengths and care preferences and evidenced patient-specific, measurable goals and outcomes. 5. Review of the clinical record for patient #8, for the certification period of 10/16/21 - 12/14/21, evidenced a comprehensive recertification assessment titled "OASIS Assessment Details" dated 10/11/21, and failed to include patient stated goal(s); failed to include whether the patient had specific care preferences; and failed to include goals or progress toward previous goals. 6. Review of the clinical record for patient #9, for the certification period of 9/22/21 - 11/20/21, evidenced a comprehensive recertification assessment titled "OASIS Assessment Details" dated 9/21/21. A subsection titled "Care Preferences" indicated "Patient has no concerns" but failed to indicate if the patient had any specific care preferences. Review of the goals indicated the patient was to receive assist as needed for care; demonstrate effective pain control; the patient's integumentary would improve as evidenced by no new wounds; the patient would verbalize signs and symptoms of respiratory and when to call; the patient would be free of urinary tract infection; the patient would verbalize signs and symptoms of hypo/hyperglycemia (low or high blood sugar); the patient would verbalize understanding of neuro disease/disorder and how to manage; the patient would be safe as evidenced by no injuries of falls; and the patient would have assistance with personal care and IADLs (Instrumental Activities of Daily Living). The recertification assessment failed to include measurable and patient-specific goals. 7. On 10/18/21 at 9 AM, employee C (alternate director of nursing) was interviewed as to the difference between an initial and a comprehensive assessment. Employee C stated, "The initial is the comprehensive. We go by Alora (the agency's electronic medical record)." When queried as to when the comprehensive recertification assessment was to be completed, employee C stated "You have 5 days before or 5 days after. It doesn't have to be exact."

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a complete and accurate assessment of the patient's medical, nursing, rehabilitative, social, and discharge planning needs in 4 of 5 active patients whose full clinical record was reviewed. (Patients #1, 3, 4, 6) Findings Include: 5. Review of the clinical record for patient #6 evidenced a resumption of care comprehensive assessment dated 9/17/21, for certification period of 8/18/21-10/16/21, with diagnosis listed as Essential (primary) hypertension, Vascular dementia without behavior, and chronic obstructive pulmonary disease failed to evidence onset dates. The section to document family supportive indicated No, and failed to list family caregivers, safety hazards identified in the home was left blank, cardiovascular status was left blank, heart sounds were left blank, edema was left blank, vital signs left blank, pain assessment indicated patient #6 denies pain, the effectiveness of pain medication left blank, integumentary status normal comment telehealth visit documented, respiratory status left blank, endocrine indicated normal with skilled nursing instruction on hypo/hyperglycemia ( conditions with diabetic patients when blood sugar levels are low and high causing effects), skill nurse indicated patient/caregiver to verbalize understanding of signs and symptoms of hypo/hyperglycemia, neuro/emotional/behavior section indicated generalized weakness, of the comprehensive assessment failed to be an accurate assessment gleaned from aa telephone call based on the patient's history. The document failed to evidence an in-person complete and accurate assessment that included the patient’s medical, nursing, rehabilitative, social and discharge planning needs. A review of the recertification (follow-up) comprehensive assessment dated 10/15/21 for certification period of 10/17/21-12/15/21, diagnosis listed as Essential (primary) hypertension, Vascular dementia without behavior, and chronic obstructive pulmonary disease failed to evidence onset dates. The section family supportive indicated no and failed to list family caregivers, Safety hazards identified in the home was left blank, cardiovascular status was left blank, heart sounds were left blank, edema was left blank, vital signs left blank, pain assessment indicated patient #6 denies pain, the effectiveness of pain medication left blank, integumentary status normal comment telehealth visit documented, respiratory status left blank, endocrine indicated normal with skilled nursing instruction on hypo/hyperglycemia ( conditions with diabetic patients when blood sugar levels are low and high causing effects), skill nurse indicated patient/caregiver to verbalize understanding of signs and symptoms of hypo/hyperglycemia, neuro/emotional/behavior section indicated generalized weakness, of the comprehensive assessment failed to be an accurate assessment gleaned from aa telephone call based on the patient's history. The document failed to evidence an in person complete and accurate assessment that included the patient’s medical, nursing, rehabilitative, social and discharge planning needs. During an interview on 10/25/21 at 10:48 AM, when queried about the comprehensive assessment accuracy, Employee H, a Registered Nurse, stated “We just call the patients we do not do home visits to complete assessments.” Employee H further confirmed assessment was completed without seeing the client or medications in the home. During an interview on 10/26/21 at 11:55 AM, when queried about nurses completing assessments, Person J, the caregiver for patient #6 confirmed the nurse called and would ask how patient #6 was feeling no other information was obtained. 410 IAC 17-14-1(a)(1)(B) 1. Review of the clinical record for patient #1, for the certification period 9/1/21 - 10/30/21, evidenced a skilled nurse visit note dated 8/27/21, used in place of a comprehensive recertification assessment, which indicated the visit was completed via telehealth. The record failed to evidence the patient received an in-person recertification assessment that included the patient's medical, nursing, rehabilitative, social, and discharge planning needs. On 10/18/21 at 1:22 PM, patient #1 was interviewed. The patient stated they could move 2 fingers but was otherwise paralyzed. Patient #1 stated they were totally dependent for all ADLs/IADLs (activities of daily living/instrumental activities of daily living) including toileting, meal preparation, hygiene, dressing, and mobility. The patient stated if no staffing was available or scheduled staff failed to show, the patient was unable to leave the wheelchair, eat, drink, toilet, or get in bed. When asked how the patient's needs were met during the absence of scheduled staff the patient #1 state was unable to eat and drink, remained confined to the wheelchair, was unable to drink or eat, experienced urinary and bowel incontinence, and slept in the wheelchair until another agency caregiver arrived. 3. Review of the plan of care for patient #3, for the certification period of 8/30/21 - 10/28/21, failed to evidence a comprehensive recertification assessment was completed that included the patient's medical, nursing, rehabilitative, social, and discharge planning needs. 4. On 10/21/21 at 10:49 AM, a home visit was conducted at the home of patient #4. During the home visit, patient #4 was observed to have excessive amounts of prescription and over-the-counter medication bottles throughout the house. The patient was queried as to why they had two monthly pill planners. The patient stated the pills that were missed get placed in the pillbox on the ledge. The surveyor observed a lazy susan behind the patient which held multiple vitamin bottles and tubes of cream. The patient was unable to verbalize what medications were currently prescribed, or their purpose. The patient also stated there had never been such a detailed visit from the clinician, who usually just set up the pills for the next 2 weeks and then left. The patient stated, "I fall all the time." The patient stated his/her daughter died 2 weeks ago, as a result of Covid, which caused extreme sadness. When queried as to whether a full medication reconciliation/review was done with each 60-day reassessment, employee C (alternate director of nursing) stated all comprehensive recertification assessments were completed via telehealth. Skilled patients were seen in person when the medication set-up was due. Review of the clinical record for patient #4, for the certification of period 9/2/21 - 10/31/21, failed to evidence a comprehensive recertification assessment was completed that included the patient's medical, nursing, rehabilitative, social, and discharge planning needs.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to complete a review of all medications the patient was currently using to identify potential adverse effects, drug reactions, ineffective drug therapy, side effects, duplicate therapy, and non-compliance in 3 of 5 active patients reviewed. (Patients #3, 4, 6,) Findings Include: 5. During a home visit on 10/22/21 at 10:25 AM, at patient #6’s home, review of the patient’s medications preset in a blister labeled packet evidenced the patient was taking the following medications; Aspirin 81 mg (milligrams) every AM by mouth, Amlodipine (dilates blood vessels to improve blood flow to treat chest pain and lowers the blood pressure) 10 mg every AM by mouth, Loratadine (Claritin for allergies) 10 mg every AM by mouth, Venlafaxine ( an antidepressant) 150 mg every AM by mouth, Omeprazole (decreases the amount of stomach acid produced treating acid reflux) 20 mg every AM by mouth, Furosemide ( prevents the body from absorbing too much salt by passing it in the urine treating fluid retention) 40 mg by mouth every AM, Gabapentin 300 mg (a anticonvulsant drug it effects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain) at Noon by mouth, POT of MICRO (Potassium Chloride) 20 mEq (milliequivalents) every evening by mouth, Pravastatin 20 mg every evening by mouth, Furosemide 40 mg every evening by mouth, Melatonin ( a supplement that aides in sleep) 5 mg every bedtime by mouth, Metoprolol (affects the heart and circulation lowering blood pressure and decreasing chest pain) 50 mg every bedtime by mouth, and Gabapentin 300mg every bedtime by mouth. Patient #6 also used Diclofenac Sodium Gel 1% topical that was rubbed on affected joint areas of hips, wrists, hands, knees, and legs at bedtime for pain. Patient #6 had 14 medications prescribed. A review of the clinical record for patient #6 evidenced an agency document titled, “Assessment Details Resumption of Care (after inpatient stay)” dated 9/17/21, for the certification period of 8/18/21 to10/16/21. The resumption of care assessment failed to evidence the clinician, Employee D reviewed the patient’s medications for updates, compliance, reactions, side effects, and duplicate medications. A review of an undated agency document titled “ Medication Profile” indicated, Name, Signature, and Date left blank...Gabapentin 600mg, 1 tab twice a day oral, Voltaren External Gel 1% 4 times daily topical, Lisinopril 20mg daily oral, Cymbalta 60 mg daily oral, Amiodarone HCL 200 mg daily oral, Tramadol HCI 50 mg oral every 6 hours as needed, Nitroglycerin Sublingual 400 mcg (micrograms) as needed 1 pill every 5 minutes..." The document titled, "Medication Profile" listed 7 prescribed medications for patient #6. A review of physician orders failed to evidence orders for medications to be added, discontinued, or changed in dosage. The clinical record failed to evidence all of patient #6's medications had been checked for potential adverse effects, drug reactions, ineffective drug therapy, side effects, duplicate therapy, and non-compliance. Two calls were placed to Entity D, the patient's physician's office on 10/22/21 at 1:51 PM, and 10/26/21 at 1:46 PM, to verify all prescriptions and over-the-counter medications patient #6 was to be taking and to ask the physician if had any concerns with patient #6's prescriptions to include potential adverse effects, drug reactions, ineffective drug therapy, side effects, duplicate therapy, and non-compliance. Messages were left for Person F, the physician's nurse for a return call. No return call was received prior to exit on 10/26/21. During a phone interview on 10/22/21 at 1:26 PM, when queried whether the agency nurse had reviewed and reconciled patient #6's medications, Person J, the patient's caregiver stated, “No, that is why we stopped them from setting up her meds because they were so unreliable.” 410 IAC 17-14-1(a)(1)(B) 1. Review of undated agency policy C-700, titled "Medication Profile", evidenced "The Nurse/Therapist shall record ... all prescribed and over-the-counter (OTC) medications the client is currently taking." Further review indicated the medication profile should include allergies, the date the medication was ordered or care was initiated, the medication's full name (with no abbreviations), dosage (using only accepted abbreviations), route and frequency of administration, contraindications or special precautions, medication actions and side effects, discontinuation date, appropriate storage directions, and drug or food-drug interactions. All prescription medication taken by the client must be ordered by a physician. The nurse should review all medications with the client and/or caregiver to ensure he/she understands how the drugs are to be stored, administered, and was aware of side effects and interactions. The policy evidenced "The Medication Profile shall be reviewed by a Registered Nurse every sixty (60) days and updated whenever there is a change or discontinuation in medication. The Registered Nurse shall sign and date the Medication Profile upon initiation and, at minimum, every sixty (60) day ... Medication profiles created through electronic point of care documentation systems will have a copy in the client record and client's home if the agency is setting up or managing the medication administration. 2. Review of undated agency policy C-709, titled "Medication Reconciliation", evidenced "Agency will reconcile all medications taken by the client prior to admission to home care ... at 60-day reassessment visits, ...." The policy defined medications to include all over the counter, prescription, regularly taken PRN (as needed) medications, herbals, and nutraceuticals that the client takes in all places of residence ... after the first 60 days, the clinician doing the reassessment will again review all medications client is taking, update the records and the client plan of care." 3. Review of the clinical record for patient #3, certification period 8/30/21 - 10/28/21, evidenced a document titled "Assessment Details", completed via telehealth. (see interview) The assessment indicated the skilled nursing assessment and evaluation included "Medication Compliance, Response" but failed to evidence the nurse completed a full medication reconciliation that included a visual review of all prescription and OTC medications the patient was taking, medication changes, the patient's understanding of dose/route/frequency/purpose of all medications, whether the patient was compliant with all medications, any medication interactions, and patient responses to medications, and failed to evidence the assessment was completed within the 5-day assessment window of day 56 - 60. On 10/18/21 at 9 AM, employee C (alternate director of nursing) stated the agency had been completing all assessments via telehealth since April 2020 due to a blanket waiver which stated initial assessments did not have to be completed in person. When asked if employee C knew the difference between an initial and a comprehensive assessment, employee C stated they were the same thing. 4. Review of the clinical record for patient #4, certification period, 9/2/21 - 10/31/21, evidenced a document titled "OASIS Assessment Details", dated 9/9/21 which indicated "medication regimen completed/reviewed with patient/caregiver." The document failed to evidence whether the patient was compliant with all medications, any medication interactions, patient responses to medications, patient understanding of dose, route, side effects, frequency, purpose, compliance, and failed to evidence the patient received a full medication reconciliation that included all prescription and OTC medications taken by the patient. The assessment also failed to evidence the patient received a full medication reconciliation/review within the 5-day window. Review of skilled nurse visit notes dated 8/26/21 and 9/9/21 indicated "Instructions/Teachings" included medication safety, but failed to evidence the patient received a full medication reconciliation/review that included compliance, understanding of dose/route/frequency/purpose, response, interactions, side effects, and response. On 10/21/21 at 11:16 AM, during a home visit, the home of patient #4 was observed to have excessive amounts of prescription and OTC medication bottles throughout the house. While accompanying the patient to obtain a medication bottle, the surveyor observed multiple plastic bins filled with medication bottles, medication bottles in the patient's bathroom, bedroom, spare room, living room, kitchen, and dining room. The patient was queried as to why they had two monthly pill planners. The patient stated sometimes there are pills that get put into the one on the ledge. The surveyor observed a lazy Susan behind the patient which held multiple vitamin bottles, tubes of cream, The patient was unable to verbalize what medications were currently prescribed and unable to identify the medications in the pillbox. Examples included, but were not limited to, a full bottle of Metformin, labeled 5/25/21 which contained 85 tablets; a sealed bottled of furosemide, 40 mg(milligram) tablets filled 1/26/21; Furosemide 40 mg, 9/9/21, sealed; Januvia 50 mg 1/31/21, sealed; Duloxetine 60mg 1/30/21, sealed; Duloxetine 60mg 6/21/21, sealed; Duloxetine 60 mg, 9/2/21; Metoprolol 50 mg, 10/7/21, sealed. The surveyor observed 5 sealed bottles of Janumet dated 5/7/21, 7/15/21, 7/15/21, 9/27/21, and 9/27/21, all sealed, and Glipizide dated 4/20/21 and 9/8/21, sealed. The patient was unable to account for the quantity of medication that was unopened and/or stored and became agitated when questioned. The patient stated they get the medication from the mail-order pharmacy, which just sends it. The patient also stated they had never received such a detailed visit and the clinician usually just set up the pills for the next 2 weeks and left. When asked if a clinician had ever reviewed all medications in the house, or had ever reviewed individual medications with the patient, the patient replied no. Employee C was queried during the visit as to the process for completing a medication review/reconciliation and medication set up and stated they had been taught to come in and put the pills into the pillboxes and was unaware anything else was required. When queried as to whether a full medication reconciliation/review was done with each 60-day assessment, employee C stated all non-skilled assessments were completed via telehealth, though employee C tried to get a med list from the physician to help. Employee C confirmed that though skilled patients were seen in person, the visit consisted of a pill set up only. When queried as to whether the physician was contacted to review or confirm medications, employee C stated they did not call the physician after an assessment or to review medications.

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 agency failed to complete the Resumption of Care assessment within 48 hours after a hospital stay, as required by agency policy, on 1 of 1 patient who required a resumption of care assessment, out of a total of 5 active patients whose clinical record was reviewed. (Patient #6) Findings Include: 1. Review of an undated agency policy titled, “Client Reassessment/Update of Comprehensive Assessment” policy number C-155 indicated, “Policy: The Comprehensive Assessment will be updated and revised as often as the client’s condition warrants due to major decline or improvement in health status…Reassessments must be done...Within forty-eight (48) hours of (or knowledge of ) client return home from hospital admission of more than twenty-four (24) hours for any reason other than diagnostic testing. 3. Within forty-eight (48) hours of (or knowledge of) discharge or transfer. Purpose: To identify decline or improvement in health status, modify the plan of care, and document changes that may affect care and reimbursement. To verify appropriate use of home care services and determine eligibility for Medicare benefit as applicable. To identify progress toward gals and effectiveness of interventions..." 2. Review of the clinical record for patient #6 evidenced an agency document titled, “Assessment Details Resumption of care (after inpatient stay)” dated 9/17/21, for certification period of 8/18/21-10/16/21. The resumption of care assessment indicated the ROC (Resumption of Care) was completed via telehealth visit with the patient. A review of an agency document titled “Resume Services” dated 9/16/21, indicated a physician signed a document titled "Resume Order," indicating, "Resume HHA (Home Health Agency) services effective 9/10/21." The resumption of care was not completed until 7 days after patient #6 was discharged from the hospital. During an interview on 10/10/26 at 11:55 AM, with patient #6’s caregiver, Person J, confirmed no nurses had been to the patient’s home since we had them stop filling medications since March of 2020, during the pandemic, due to the agency's unreliable staffing of nurses. Patient #6 caregiver, Person J, indicated patient #6 was hospitalized 3 times this year, and at the end of last year had trouble with a heart condition that required double bypass surgery (a surgical procedure on the heart to restore normal blood flow to an obstructed coronary artery). Patient # 6 was also hospitalized for COVID, respiratory failure, and a fall. During an interview on 10/25/21 at 10:48 AM, Employee H, RN (Registered Nurse) for patient #6, confirmed the Resumption of Care assessment was completed 7 days after the patient was released from the hospital, and assessments were completed per telephone conversations not by conducting an in-person assessment.

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 agency failed to ensure discharged patients received an updated comprehensive assessment that included a summary of the patient's progress in meeting the care plan goals for 2 of 2 discharged patients whose clinical record was reviewed. (Patients #2 and 7) Findings include: 1. Review of undated policy C-500, titled "Client Discharge Process", evidenced "Discharge OASIS [Outcome and Assessment Information Set] will be conducted within 48 hours of (or knowledge of) discharge to the community or death at home." The policy failed to evidence the patient should receive a comprehensive assessment that included a summary of the patient's progress in meeting the care plan goals. On 1//18/21 at 3:30 PM, the policy and procedure manuals and table of contents were reviewed for additional policies, and employee A was queried as to whether there was additional policy and procedure information in the agency. Employee A stated there was no further information and the binders provided to the surveyors contained all agency policies and procedures. 2. Review of the clinical record for patent #2, discharge date 7/12/21, evidenced a comprehensive assessment dated 7/2/21. No further assessment of skilled nurse visit note was available after 7/12/21. The record failed to include documentation of when and why the patient was discharged, whether the physician was notified, and whether discharge information/summary was sent to the patient's physician. On 10/19/21 at 2:45 PM, the surveyor requested the following copies of the clinical record for patient #2 from employee B: For certification period 6/30/21 - 8/28/21 (discharge date 7/12/21): Plan of Care/485, aide visit notes, aide care plan, orders, comprehensive assessment, all communication notes, and all discharge paperwork. On 10/19/21 at 3:52 PM, employee B provided the requested documents and stated there was no additional information available. When queried as to why the patient was discharged, employee A stated the patient went to another agency. On 10/15/21 at 10 AM, patient #2 was interviewed by phone and stated he/she left the agency because an agency employee was stealing from the patient. The patient described missing money on several occasions, a wallet, and "other items". The patient stated "I find new stuff missing every day." Patient #2 stated he/she had called the police and was going to call again because the employee kept breaking in. The patient stated individual C (the patient's current aide through another agency and a previous employee of Golden Heart Health Service) was questioned by Golden Heart, around July 2, 2021, and became angry and terminated employment with Golden Heart due to accusations of involvement with the theft and issues with boundaries. Patient #2 indicated individual C followed the patient to the agency that currently provided services. Patient #2 was queried as to whether a 15-day discharge notice or a comprehensive assessment was provided and responded "No. One day they were coming and then [Name of individual ] quit, and they ain't been back since. I couldn't get help until I finally got my current agency." 3. Review of the clinical recorded for patient #7, discharge date 10/13/21, evidenced a plan of care from certification period 8/22/21 - 10/20/21 and a comprehensive assessment dated 8/31/21. The record failed to evidence an assessment after 8/31/21. The clinical record also evidenced home health aide visit notes from 8/22/21 - 9/10/21. The record failed to evidence aide visit notes after 9/10/21. Review of an order titled "Recertification Order" dated 8/18/21, evidenced "May re-certify for another 60-day episode for HHA (home health aide) assistance under Medicaid PA (Prior Authorization). No further orders were available. The clinical record failed to evidence the patient was discharged from service, including the reason for discharge. On 10/19/21 at 10 AM, employee A (agency owner) was queried as to the reason for the patient's discharge. Employee A stated not being able to remember anything about the patient and would have to reference the clinical record. Employee E (scheduling coordinator) was then queried as to the reason for discharge, and stated, "The patient was going to move so we put [him/her] on hold just to make sure and in case [he/she] didn't move. Then we finally discharged [him/her]. When queried as to documentation concerning the patient's move, employee E referenced Alora (the agency's electronic medical record) and reviewed the patient's communication notes with the surveyor present. Employee E stated there were no available notes related to the patient's discharge. The record failed to evidence the patient received a comprehensive assessment when discharged, and failed to evidence a summary of the patient's progress towards goals. On 10/22/21 at 2:17, the patient was contacted via phone. Upon answering, patient #7 became aggressive and yelled, "Why would I need home care when I don't have a home?" The patient refused to answer further questions. At 2:24 the surveyor contacted employee M (home health aide) who stated "The patient was on meth (methamphetamine - a highly addictive street drug) and panhandles now, and I don't think the agency knew that. The employee stated they were reassigned from the patient "a while ago" and had no further information.

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 agency failed to ensure a discharge or transfer summary that included the necessary medical information pertaining to the current course of illness and treatment, post-discharge goals of care, and treatment preferences was sent to the receiving facility or health care practitioner in 2 of 3 discharged patients reviewed. (Patients #2, 7) 1. Review of an undated agency policy C-500, titled "Client Discharge Process" evidenced 'Agency staff will complete complete a discharge summary that includes the following information: a. Patient status at the time of admission to the agency. b. Statement of care and interventions provided and outcomes of care. c. Status at discharge/last visit/current medications, therapies, and continuing care needs. d. Name of person or organization assuming responsibility for care. e. Instructions and referrals given to the patient/family/caregiver. f. Reason for discharge and date of discharge. 6. A copy of the discharge summary is mailed to the physician upon request." The agency failed to update its policy to reflect the current regulations for discharge summary to the physician. On 1//18/21 at 3:30 PM, the policy and procedure manuals and table of contents were reviewed for additional policies, and employee A was queried as to whether there was additional policy and procedure information in the agency. employee A stated there was no further information and the binders provided to the surveyors contained all agency policies and procedures. 2. Review of the clinical record for patent #2, discharge date 7/12/21, evidenced a comprehensive assessment dated 7/2/21. No further assessment of skilled nurse visit note was available after 7/12/21. The record failed to include documentation of when and why the patient was discharged, whether the physician was notified, and whether discharge information/summary was sent to the patient's physician. On 10/19/21 at 2:45 PM, the surveyor requested the following copies of the clinical record for patient #2 from employee B: For certification period 6/30/21 - 8/28/21 (discharge date 7/12/21): Plan of Care/485, aide visit notes, aide care plan, orders, comprehensive assessment, all communication notes, and all discharge paperwork. On 10/19/21 at 3:52 PM, employee B provided the requested documents and stated there was no additional information available. When queried as to why the patient was discharged, employee A stated the patient went to another agency. On 10/15/21 at 10 AM, patient #2 was interviewed by phone and stated he/she left the agency because an agency employee was stealing from the patient. The patient described missing money on several occasions, a wallet, and "other items". The patient stated "I find new stuff missing every day." Patient #2 stated he/she had called the police and was going to call again because the employee kept breaking in. The patient stated individual C (the patient's current aide through another agency and a previous employee of Golden Heart Health Service) was questioned by Golden Heart, around July 2, 2021, and became angry and terminated employment with Golden Heart due to accusations of involvement with the theft and issues with boundaries. Patient #2 indicated they followed individual C to the agency they are currently with. Patient #2 was queried as to whether had received a 15-day discharge notice or a comprehensive assessment and responded "No. One day they were coming and then [Name of individual ] quit, and they ain't been back since. I couldn't get help until I finally got my current agency." 3. Review of the clinical recorded for patient #7, discharge date 10/13/21, evidenced a plan of care from certification period 8/22/21 - 10/20/21, and a comprehensive assessment dated 8/31/21. The record failed to evidence an assessment after 8/31/21. The clinical record also evidenced home health aide visit notes from 8/22/21 - 9/10/21. The record failed to evidence aide visit notes after 9/10/21. Review of an order titled "Recertification Order" dated 8/18/21 evidenced "May re-certify for another 60-day episode for HHA (home health aide) assistance under Medicaid PA (Prior Authorization). No further orders were available. The clinical record failed to evidence the patient was discharged from service, including the reason for discharge. On 10/19/21 at 10 AM, employee A was queried as to the reason for the patient's discharge. Employee A stated not being able to remember anything about the patient and would have to reference the clinical record. Employee E was then queried as to the reason for discharge, and stated, "The patient was going to move so we put [him/her] on hold just to make sure and in case [he/she] didn't move. Then we finally discharged [him/her]. When queried as to documentation concerning the patient's move, employee E referenced Alora (the agency's electronic medical record) and reviewed the patient's communication notes with the surveyor present. Employee E stated there were no available notes related to the patient's discharge. The record failed to evidence the patient received a comprehensive assessment when discharged. On 10/22/21 at 2:17, the patient was contacted via phone. Upon answering, patient #7 became aggressive and yelled, "Why would I need home care when I don't have a home!" The patient refused to answer further questions. At 2:24 the surveyor contacted employee M, a home health aide, who stated "The patient was on meth (methamphetamine - a highly addictive street drug) and panhandles now, and I don't think the agency knew that. The employee stated having been reassigned from the patient "a while ago" and had no further information.

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 agency failed to ensure patients were accepted for services on the reasonable expectation the provider could meet their needs, failed to ensure the individualized plans of care specified the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment; (See G570); failed to ensure the plan of care was established with the physician/ or consulted to approve additions or modifications to the original plan of care, failed to ensure the plan of care was accurate, contained patient-specific and individualized interventions, measurable outcomes, and goals (See G572); failed to ensure the plan of care was individualized and included all pertinent diagnoses with their date of onset, all supplies, and equipment in the home to meet the patients' needs, specific frequency and duration of visits, nutritional requirements, accurate medications and treatments, all safety measures, infection control precautions, risk for emergency department visits and hospital readmission, services being provided by outside agencies/ facilities, all necessary interventions, specific education and training to be provided, measurable outcomes and goals identified by the home health agency and patient, and a provision orders could be received/ accepted by outside physicians (See G574); failed to ensure all services, treatments, and medications were ordered by the physician that established the plan of care prior to providing services (See G580); failed to ensure all orders were accurate and did not indicate Verbal Order (V/O) when the order was written by the agency and sent to the attending physician for signature, failed to ensure orders were complete with home health aide duties, date the clinician had obtained the order, and physician signature and date (See G584); failed to ensure clinical records included information about the services the patient received from other agencies and failed to ensure they coordinated care delivery to meet the patient’s needs (See G606); failed to ensure clinical records included information about the services the patient received from other agencies and failed to ensure they coordinated care delivery to meet the patient’s needs (See G608); failed to provide visit schedules including frequency of the visits of the home health aide according to the most updated plan of care (See G614); failed to ensure a medication list was provided to the patient (See G616); and failed to ensure all patients were provided with a copy of written instructions outlining the name and contact information of the home health clinical manager/ director of nursing (See G622) in 8 out of 9 patient records sampled (Patients’ # 1, 2, 3, 4, 6, 7, 8, 9). These deficient practices have the potential to affect all patients receiving home health services from this provider. The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with the Condition of Participation 42 CFR 484.60 Care planning, Coordination, Quality of Care. Findings include: 1. Review of undated agency policy C-580, titled "Plan of Care", evidenced "Home care services are furnished under the supervision and direction of the client's physician. The Plan of Care is based on a comprehensive assessment and information provided by the client/family and health team members … 3. If a physician refers a client under a Plan of Care that cannot be completed until after an assessment visit the physician shall be consulted to approve additions or modifications to the original plan. The skilled assessment visit order will be documented on a Doctor's Order Form and mailed to the physician for signature .... “ 2. The clinical record of patient #1 was reviewed and contained a skilled nurse visit note dated 9/27/21, which was used as a comprehensive recertification assessment. The cardiovascular and genitourinary system note indicated the assessment was “via telehealth.” A review of the visit note failed to evidence the patient's complete health, pertinent diagnoses, psychosocial, functional, and mental status. A review of the plan of care for the certification period of 9/1/21 - 10/30/21, revealed several diagnoses without dates of onset, medications, interventions, durable medical equipment (DME,) Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. On 10/20/21 at 2:01 PM, the patient was interviewed concerning the services received. Patient #1 denied speaking with the clinician concerning the plan of care and stated they have never met a clinician in person for an assessment and development of the plan of care because all communication was via phone. The patient stated lived alone and required maximum assist due to a diagnosis of spastic quadriplegia related to cerebral palsy. Patient #1 stated experiencing frequent nausea and vomiting due to reflux and required repositioning assistance. The plan of care failed to be supported by a complete comprehensive assessment. 3. The clinical record of patient #2 was reviewed and contained a document titled “Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 4/26/21. Several sections of this assessment indicated “telehealth” or “telehealth visit.” A review of the plan of care for the certification period of 5/1/21 - 6/29/21 revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. The plan of care revealed orders for home health aide services 7 – 16 hours/ day, 5 – 7 times a week for 9 weeks to assist with ADL’s/ IADL’s (activities of daily living which consist of basic self-care tasks like bathing, ambulation, meals/ Instrumental activities of daily living which consist of housekeeping and preparing meals) per home health aide plan of care. A review of the home health aide visits notes during the certification period of 5/1/21 to 6/29/21 failed to evidence at least 5 visits during the week of 5/31/21, week of 6/7/21, and failed to evidence any further visits have been made after 6/10/21. A review of the plan of care for the certification period of 6/30/21 - 8/28/21, revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. The plan of care revealed orders for home health aide services 7 – 16 hours/ day, 5 – 7 times a week for 9 weeks to assist with ADL’s/ IADL’s per the home health aide care plan. The plan of care was signed by former employee S (registered nurse) without a date. The plan of care failed to evidence a physician's signature or that a signed order was received in Section 25. A review of a document titled “Assessment Details” failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 7/2/21. Several sections of this assessment indicated “telehealth” or “telehealth visit.” A review of an agency document titled “Recert Order” dated 7/2/21 indicated “Recert V/O – May re-certify for another 60-day episode for HHA assistance under Medicaid PA continue HHA 13 hrs/ day 7 days/week services for home health”. A review of the plan of care for the certification period of 6/30/21 to 8/28/21, revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. A review of the home health aide visits notes failed to evidence any services had been provided. A review of another document titled “Assessment Details” dated 7/12/21, indicated the patient was discharged. During an interview on 10/15/21 at 2:11 PM, person B, the patient’s friend, stated he/she has been helping the patient since the patient was “fired” from the agency on June 6th, and that was the last time anyone had been out to provide services. The plans of care failed to be supported by a complete comprehensive assessment and failed to meet the needs of the patient by failing to provide home health aide services per the plan of care. 4. The clinical record of patient #3 was reviewed and contained a document titled “Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 8/31/21. Several sections of this assessment indicated “via telehealth visit.” A review of the plan of care for the certification period of 8/30/21 - 10/28/21, revealed several diagnoses without dates of onset, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. The plan of care indicated the patient was to receive home health aide services 9 hours a day 5 days a week. A review of the agency’s document titled “Recert Order” dated 9/21/21, indicated “Recert V/O – May re-certify for another 60-day episode for HHA assistance under Medicaid PA Continue HHA 9 hrs/day 5 days/week services for home health.” A review of a skilled nursing visit note dated 9/27/21 dated 8:00 AM to 9:00 AM, in the vital sign section and each body system section thereafter, indicated “Via telehealth visit.” A review of the home health aide visit notes for certification period 8/30/21 - 10/28/21, revealed visit notes on 9/24, 9/28, 10/4, 10/6, 10/8, 10/9, and 10/11/21. No further visit notes were available to review for the certification period of 8/30/21 - 10/28/21. The plans of care failed to be supported by a complete comprehensive assessment and failed to meet the needs of the patient by failing to provide home health aide services per the plan of care. 5. The clinical record for patient #4 was reviewed and contained a document titled “OASIS Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. The genitourinary system indicated the patient was incontinent of urine. This document indicated it was for recertification and was completed on 9/9/21. Several sections of this assessment indicated “via telehealth visit.” Page 20 of 28 indicated “No” when asked if the patient/ caregiver refused HHA services at this time and “N/A” for frequency and duration. Further review of the clinical record revealed an interim order dated 9/9/21, on agency letterhead and indicated “Recert V/O - May re-certify for another 60-day episode for HHA [home health aide] assistance under Medicaid PA Skilled nursing for med [medication] fill every other week x 9 weeks.” A review of the plan of care for the certification period of 9/2/21 - 10/31/21, revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals, and incorrectly indicated the patient had a urinary ostomy. The clinical record failed to evidence that the agency provided home health aide services per the interim order on 9/9/21, the plan of care failed to be supported by a complete and accurate comprehensive assessment. 6. The clinical record for Patient #6 was reviewed and contained “Assessment Details” dated 10/15/21 and indicated the document was a recertification assessment. The assessment failed to evidence a complete and accurate assessment and indicated throughout different sections that it was a “Telehealth visit”. The elimination status indicated the patient was incontinent. A review of a skilled nursing visit note dated 10/15/21, indicated it was a telehealth visit and failed to evidence a complete and accurate assessment. Throughout the body system sections indicated “Telehealth visit”. The assessment note indicated the patient was incontinent. A review of the plan of care for the certification period of 10/17/21 to 12/15/21, revealed an order for home health aide services 8 hours a day, for 5 days a week, for a total of 40 hours a week to assist with all ADLs/IADLs and the durable medical equipment section indicated the patient had urostomy supplies (a pouch that sticks to the abdomen and catches urine from an opening). During an interview on 10/26/21 at 11:55 AM, Person J, a family member stated, “No nurse has seen [Name of Patient #6] since the pandemic. We stopped them from setting up [Name of Patient #6] medications because we could not rely on them. The nurse called once said [he/she] had to speak to us for [Name of Patient #6] to continue services. The plans of care failed to be supported by a complete comprehensive assessment. 7. The clinical record for Patient #7 was reviewed and contained a skilled nursing visit note dated 8/17/21, which indicated the visit was a “Telehealth visit”. Several body system sections throughout the assessment were incomplete. The general notes indicated this document was for a recertification visit that was completed via telehealth. A review of the plan of care for the certification period of 8/22/21 to 10/20/21, revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. The plans of care failed to be supported by a complete comprehensive assessment. 8. The clinical record of patient #8 was reviewed and contained a document titled “OASIS Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. This document indicated it was for recertification and was completed on 10/11/21. A review of the plan of care for the certification period of 10/12/21 - 12/10/21, revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. The plans of care failed to be supported by a complete comprehensive assessment. 9. The clinical record of patient #9 was reviewed and contained a document titled “OASIS Assessment Details” which failed to evidence a complete head-to-toe comprehensive assessment. The general notes section indicated “Recert Telehealth completed at this time.” A review of the plan of care for the certification period of 9/22//21 - 11/20/21, revealed several diagnoses, medications, interventions, DME, Safety Measures, Nutritional Requirements, Activities, Mental Status, Prognosis, and lack of patient-specific goals. The plan of care failed to be supported by a complete comprehensive assessment. 10. During an interview on 10/18/21 at 9 AM, employee C (alternate director of nursing) stated that all comprehensive assessments were completed over the phone, by interviewing the patient or patient’s caregiver. When queried as to when findings of the comprehensive assessment were reviewed with the physician/designee to establish the plan of care, employee C indicated they don’t call the physician to review findings or obtain orders. 11. During an interview on 10/22/21 at 11:06 AM, employee H (Registered Nurse) was queried as to when the physician was called to review comprehensive assessment findings. Employee H stated they had never called the physician to review findings.

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 plan of care was established with the physician/ or consulted to approve additions or modifications to the original plan of care, failed to ensure the plan of care was accurate, contained patient-specific and individualized interventions, measurable outcomes, and goals for 4 of 5 full records reviewed. (patients #1, 3, 4, 6) and 2 of 2 closed records reviewed. (patient #2, 7) Findings include: 8. The clinical record for Patient #6 was reviewed and contained a comprehensive assessment dated 9/17/21, which included diagnoses of essential (primary) hypertension, vascular dementia without behavior, and chronic obstructive pulmonary disease. The comprehensive assessment failed to evidence individualized patient-specific measurable outcomes and goals. A review of the plan of care for the certification period of 8/18/21 - 10/16/21, revealed interventions for the skilled nurse to assess vital signs, instruct on home safety, diagnosis management, medications, and spot check SpO2 (oxygen saturation levels). Call orders included blood pressure > 180/100, 20 and 100 or 100 or 180/100, 20 and 100 or 100 or 180/100, 20 and 100 or 100 or 180/100, 20 and 100 or 100 or Due to the patient's diagnosis of hypertension, the blood pressure parameters are generalized and fail to be specific to the physician-ordered parameters. 5. The clinical record for Patient #4 was reviewed and contained a plan of care for the certification period of 9/2/21 - 10/31/21. This plan of care contained the following diagnoses but not limited to Essential hypertension; hypertensive heart disease with heart failure, longstanding persistent atrial fibrillation; type 2 diabetes with hyperglycemia, but failed to evidence a diagnoses consistent with the use of fluticasone propionate inhaled powder (medication to treat seasonal allergies, omeprazole medication to treat reflux/heartburn), levothyroxine (medication to treat low thyroid), Lyrica ( medication to treat neuropathy), cholecalciferol (medication to replace Vitamin D), and ezetimibe ( medication to treat cholesterol). Interventions included for the skilled nurse to assess vital signs, instruct on home safety, diagnosis management, medications, and spot check SpO2 (oxygen saturation levels). Call orders included blood pressure > 180/100, 20 and 100 or 100 or Due to the patient's diagnosis of hypertension, the blood pressure parameters are generalized and fail to be specific to the physician-ordered parameters. The plan of care failed to include physician-ordered parameters of when to report elevated blood sugars. 6. The clinical record for Patient #7 was reviewed and contained a plan of care for the certification period of 10/16/21 - 12/14/21. This plan of care contained diagnoses but not limited to Essential hypertension with secondary diagnoses of diabetes due to underlying condition with hyperglycemia, obstructive sleep apnea (adult) (pediatric), dysphagia, pharyngeal phase, and chronic obstructive pulmonary disease with acute exacerbation. Interventions included for the skilled nurse to assess vital signs, instruct on home safety, diagnosis management, medications, and spot check SpO2 (oxygen saturation levels). Call orders included blood pressure > 180/100, 20 and 100 or 100 or Due to the patient's diagnosis of hypertension, the blood pressure parameters are generalized and fail to be specific to the physician-ordered parameters. The plan of care failed to include physician-ordered parameters of when to report elevated blood sugars. 7. During an interview on 10/22/21 at 11:06 AM, Employee H, RN, was interviewed concerning contacting the physician to review assessment findings and develop a plan of care. Employee H stated. "I've never actually called the doctor's office. There is a tab [in Alora- the agency's electronic medical record] where you can generate orders ...."

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the plan of care was individualized and included all pertinent diagnoses with their date of onset, all supplies, and equipment in the home to meet the patients' needs, specific frequency, and duration of visits, nutritional requirements, accurate medications and treatments, all safety measures, infection control precautions, risk for emergency department visits and hospital readmission, services being provided by outside agencies/ facilities, all necessary interventions, specific education and training to be provided, measurable outcomes and goals identified by the home health agency and patient, and a provision orders could be received/ accepted by outside physicians for 4 of 5 active records reviewed (patients #1, 3, 4, 6,) and 1 of 2 closed records reviewed (patient #7). Findings Include: 6. During a home visit on 10/22/21 at 10:25 AM, patient #6 was observed ambulating from the bathroom to the bedroom approximately 10 steps very short of breath. Patient #6 sat on the edge of the bed stating, “Give me a minute. As soon as I get enough wind in me you can do my hair.” Observed a CPAP (Continuous positive airway pressure is a machine that delivers constant and steady air pressure to help a patient breathe at night who have sleep apnea, a disease that a patient’s airway closes or gets blocked causing a patient to stop breathing) mask at patient’s bedside. When queried about the mask the patient stated, “They say I stop breathing at night." When queried about the ointment on the bedside table, patient #6 confirmed had pain in legs and arms that would keep [sic patient #6] up at night. Patient #6 indicated seeing a cardiologist and neurologist. A review of a recertification assessment, dated 10/15/21, and was a telehealth visit, indicated patient #6 had the diagnoses of vascular dementia, chronic obstructive pulmonary disease, cerebral infarction, and mild intermittent asthma. The patient lived alone, had decreased mobility, was at high risk for falls, required assistance with bathing, incontinent care, medication reminders, meals, and light housekeeping. The patient was oriented and forgetful, used a walker for ambulation and was short of breath on exertion, was on a regular diet, and had no pain. A review of an agency document titled, "Aide Care Plan' dated 8/18/21, indicated the patient's diet was low sodium, the patient was allergic to smoke, and before entering the client's home please change clothes and wash your hands. During an interview on 10/26/21 at 12:15 PM, Person K, a family member confirmed patient #6 sees a cardiologist who treats patient #6 after double bypass surgery last year. Person K further confirmed that patient #6 received waiver services from Entity M. A review of patient #6's plan of care for the recertification period 10/17/21 to 12/15/21, failed to evidence dates of onset for the pertinent diagnoses; failed to evidence patient specific frequency, and duration of all HHA (home health aide) visits/services (HHA 2-9 hours per day, 2-7 times a week, for 9 weeks); all durable medical equipment (DME) /supplies to include CPAP, and CPAP supplies, half one side bed rail; all accurate medications and treatments, (missing Gabapentin 300mg (milligrams) twice daily by mouth, Potassium Chloride 20 mEq (milliequivalents) once a day by mouth, Furosemide 40 mg twice a day by mouth, Prevastatin 20mg once a day by mouth, Melatonin 5 mg every bedtime by mouth, Metoprolol 50mg at bedtime by mouth, Venlafaxine 37.5 mg every morning by mouth, Loratadine 10mg every morning by mouth, Amlodipine 10mg every morning by mouth, and Aspirin 81 mg every morning by mouth;) evidenced regular diet was ordered rather than low sodium diet; instructions to client/caregiver; treatment goals; detailed discharge plans; patient selected goals; patient specific interventions for pain, respiratory and cardiac, skin integrity related to incontinence, risk for rehospitalization, and measurable goals, detailed and realistic discharge plans; waiver attendant services provided by Entity M; failed to include other physician managing the patient #6 care (patient #6 had a cardiologist and neurologist); and failed to address all necessary interventions for the patient’s underlying risk factors. A review of an agency document titled, “Aide Care Plan” indicated the patient’s diet was low sodium, the patient was allergic to smoke before entering the client's home please change clothes and wash your hands. A review of an agency document dated 10/5/21 with start time 11:00 AM, titled, “Aide Visit Note” indicated, “Took patient #6 to the Dr.(doctor). The Dr. will refer her to a neuro (neurologist) for nerves in her leg. She was having trouble walking today, out of breath and in pain from her right hip and leg.” During an interview on 10/26/21 at 12:15 PM Person K, a family member confirmed patient sees a cardiologist who treats patient #6 after her double bypass last year. Person K further confirmed that patient #6 receives waiver services from Entity M and that Entity H assists them with community resources. 410 IAC 17-13-1(a)(1)(B) 410 IAC 17-13-1(a)(1)(C) 410 IAC 17-13-1(a)(1)(D)(i,ii,iii,v,vi,vii,viii,ix,x,xi,xiii) 1. Review of undated agency policy C-580, titled "Plan of Care", evidenced "Home care services are furnished under the supervision and direction of the client's physician. The Plan of Care is based on a comprehensive assessment and information provided by the client/family and health team members. Planning for care is a dynamic process that addresses the care, treatment, and services to be provided. The plan will be consistently reviewed to ensure that client needs are met and will be updated as necessary, but at least every sixty (60) days... The Plan of Care shall be completed in full to include: a. All pertinent diagnosis(es), principle, and secondary, including dates of onset. b. Mental status. c. type, frequency, and duration of all visits/services. d. Specific procedures and modalities for therapy services. e. Diagnostic tests, including laboratory and x-rays. f. Surgical procedure(s). g. Prognosis. h. Rehabilitation potential. i. Functional limitations and precautions. j. Activities permitted or restrictions. K Specific dietary or nutritional requirements or restrictions. l. Medications, treatments, and procedures. m. Medical supplies and equipment required. n. Any safety measures to protect against injury. o. Instructions to client/caregiver, as applicable. p. Treatment goals. q. Instructions for timely discharge or referral. r. Discharge plans. s. Name and address of client's physician. t. Other appropriate items. u. All of the above items must always be addressed on the Plan of Care." further review evidenced "3. If a physician refers a client under a Plan of Care that cannot be completed until after an assessment visit the physician shall be consulted to approve additions or modifications to the original plan. The skilled assessment visit order will be documented on a Doctor's Order Form and mailed to the physician for signature ... 2. Review of the plan of care for patient #1, certification period 9/1/21 - 10/30/21, evidenced a primary diagnosis of spastic quadriplegic cerebral palsy, with secondary diagnoses of cerebral palsy, other cerebral palsy, muscle weakness (generalized), and mixed incontinence, but failed to include all dates of diagnosis. Functional limitations of bowel/bladder incontinence, paralysis, endurance, and ambulation. The patient was oriented, with a prognosis of fair. Discharge plans and rehab (rehabilitation) potential indicated "When patient returns to independent level of care. Discussed discharge plans with patient/caregiver: Yes. Rehab Potential: Fair. Patient #1 took no medications. Orders indicated home health aide (hha) 7 - 16 hours/day x 5 - 7 x/week x 9 weeks to assist with ADLs/IADLs (Activities of Daily Living/Instrumental Activities of Daily Living,) per hha care plan, and skilled nurse at least every 4 weeks x 9 weeks for hha supervision with 1 PRN (as needed) visit to capture recertification window. The skilled nurse was to assess vital signs, instruct on home safety, diagnosis management, medications, and spot check SpO2 (oxygen saturation levels). Call orders included blood pressure > 180/100, 20 and 100 or 100 or 180/100, 20 and 100 or 100 or 180/100, 20 and 100 or 100 or 0.05 - 1%, topically 1 Application 2x daily but failed to include where to apply, Nitrostat Sublingual Tablet 0.4 MG tab, as directed PRN but failed to include the as needed reason, Polyethylene Glycol Powder 17 gm (grams) mix with Konsyl by mouth but failed to include the frequency and instructions for mixing/amount of liquid to use, and Ozempic 1 mg/dose subcutaneous solution pen injector 2 mg/1.5 ml (milliliters) injection every 7 days IM (intramuscular) but failed to use the correct route (subcutaneously) and failed to include an order for nursing to administer the medication. Orders included skilled nurse for medication fill: 1 x/week every week for 9 weeks for medication set up and management. Skilled nurse to obtain vitals. Call orders included blood pressure > 180/100, 20 and 100 or 100 or <60, and SpO2< 90%, failed to include blood sugars and failed to be individualized for the patient. The patient goals included "Pt (patient) will remain safe at home as evidenced by no falls injuries for the length of the home health episode. Patient will have no unplanned hospitalizations for the length of certification period" but failed to evidence reasonable and realistic patient-specific goals related to the reason for home health and need for medication assistance. The plan of care failed to be patient-specific and individualized. The plan of care evidenced "Coordination of Care: Pt has PCP (primary care physician) [Name of person U (a physician)] and SN [skilled nurse]. Pt has HHA (home health aide) through [Name of Entity P] and {Name of entity Q] but failed to evidence what care coordination occurred, what the services provided from each, and participation in the plan of care. Review of the clinical record failed to evidence documentation of care coordination.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all services, treatments, and medications were ordered by the physician that established the plan of care prior to providing services in 5 of 6 active patients reviewed. (patient's #1, 3, 4, 8, 9) Findings include: 1. Review of undated agency policy C-635, titled "Physician Orders", indicated " ... All medications, treatments, and services provided ... must be ordered by a physician. The orders may be initiated via telephone or in writing and must be countersigned by the physician in a timely manner ... All medicines and treatments that are part of the client's plan of care must be ordered by the physician ... All verbal orders must be "read back" to the physician to verify the accuracy of the orders and decrease errors." 2. Review of the clinical record for patient #1, start of care 1/4/21, for the certification period of 9/1/21 - 10/30/21, evidenced a document titled "Recert Order" (Recertification Order), dated 9/21/21. The document indicated "Verbal Read Bac [sic] Yes" and indicated "Recert V/O (Verbal Order) - may re-certify for another 60-day episode for HHA (Home Health Aide) under Medicaid PA (Prior Authorization). Continue HHA (Home Health Aide) 7-16 hours/day, 5-7 days/week services for HHA." The order was signed by employee H (Registered Nurse) on 9/21/21 at 3:51 PM. physician signature line contained an illegible signature and was dated 9/23/21. The signature was untimed. Further review evidenced a second and identical "Recert Order", but evidenced a blank physician signature line dated 9/23/21 at 12:00 AM. The record failed to evidence orders for care, medications, and treatment were obtained from the physician in advance of providing services. 3. Review of the clinical record for patient #3, start of care 11/3/20, for the certification period of 8/30/21 - 10/28/21, evidenced a "Recert Order" dated 9/21/21. The document indicated "Verbal Read Bac [sic] Yes" and indicated "Recert V/O - may re-certify for another 60 - day episode for HHA under Medicaid PA. Continue HHA 9 hours/day, 5 days/week services for Home Health." The order was signed by employee H on 9/21/21 at 3:47 PM. The physician signature line was blank and undated. The record failed to evidence orders for care, medications, and treatment were obtained from the physician in advance of providing services. 4. Review of the clinical record for patient #4, start of care 9/13/19, for certification period 9/2/21 - 10/31/21, evidenced a "Recert Order" dated 9/9/21. The document indicated "Verbal Read Bac [sic] Yes" and indicated "Recert V/O (Verbal Order) - may re-certify for another 60 - day episode for HHA assistance under Medicaid PA. Skilled nursing for medfill every other week x 9 weeks." The "Recert Order" was signed by employee D on 9/9/21 at 1:19 PM and evidenced an untimed illegible physician signature dated 9/15/21. The physician signature line was blank and undated. The record failed to evidence orders for care, medications, and treatment were obtained from the physician in advance of providing services. 5. Review of the clinical record for patient #8, start of care 4/24/20, for certification period 10/16/21 - 12/14/21, evidenced a document titled "Verbal Order" dated 10/11/21. The document indicated "Verbal Read Bac [sic] Yes" and indicated "Recert V/O - may re-certify for another 60 - day episode for HHA assistance under Medicaid PA. Continue skilled nurse 1hr (hour)/day x 1 day/week.Services for weekly medication box fill and weekly SQ (subcutaneous - a type of injection just under the skin) diabetic medication injection. The record evidenced orders for care, medications, and treatment were obtained from the physician prior to completing an assessment of the patient's needs for continued services. 6. Review of the clinical record for patient #9, start of care 2/16/17, for certification period of 9/22/21 - 11/20/21 evidenced a document titled "Recert Order" dated 9/21/21. The document indicated "Verbal Read Bac [sic] Yes" and indicated "Recert V/O - may re-certify for another 60 - day episode for Home Health, skilled nursing weekly med fill." The order was signed by employee D and was dated 9/21/21 at 11:42 AM. The physician signature line was blank, but dated 9/30/21 at 12:00 AM. Further review evidenced a second identical "Recert Order" and evidenced an illegible physician signature and was dated 9/22/21. The record failed to The record evidenced orders for care, medications, and treatment were obtained from the physician prior to completing an assessment of the patient's needs for continued services. 7. On 10/18/21, at 9 AM, employee C (alternate director of nursing) was interviewed concerning orders. When asked about the recertification process, employee C indicated the clinician completed a recertification comprehensive every 60 days based on the schedule in Alora, the agency's electronic medical record, then printed the verbal order and sent it to the physician to be signed. The clinicians never actually called the physician's office to review findings. When queried concerning the agency's process for a patient's start of care (SOC) orders, employee C stated there were orders in Alora specific for starts of care and denied obtaining verbal orders prior to or after a patient is seen for a comprehensive assessment at the start of services. When queried as to how the frequency of services was determined, employee C stated, "CICOA (Area Agency on Aging and Disability) tells us... and the patient also tells us." On 10/22/21 at 11:06 AM, employee H (registered nurse) was interviewed concerning whether the clinician called a physician/designee to review findings and obtain orders for continuing services after a comprehensive recertification assessment was completed. Employee H stated, "I've never actually called a patient's doctor before. There is a tab [in Alora] where you can generate orders for "May recertify.""

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical records included information about the services the patient received from other agencies and failed to ensure they coordinated care delivery to meet the patient’s needs for 1 of 1 active patient records reviewed (Patients #6) receiving outside services. Findings Include: 1. A review of the clinical record for patient #6 evidenced an agency document dated 1/22/21 titled, "Patient Communication Log" indicated, "Family called and stated they would like a medical caregiver that can assess the patient for distress. Please only use Person O for the waiver side and not PA (Prior Authorization). The family stated patient is a high risk for heart attack/choking." Review of the resumption of care assessment (after an inpatient stay) dated 9/17/21, failed to evidence that the patient was receiving waiver services from another agency. Review of the recertification (follow up) assessment dated 10/15/21, failed to evidence that the patient was receiving waiver services from another agency. A review of the plan of care for the certification period 10/17/21 to 12/15/21, failed to evidence that the patient was receiving waiver services from another agency. Review of all the agency documents titled, “Patient Communication Log” dated 8/26/19 to present, failed to evidence coordination of care with the waiver agency and failed to evidence coordination of care with Entity N, the inpatient facility during patient’s stay. During an interview on 10/22/21 at 12:43 PM, the caregiver for patient #6, Person J, confirmed patient #6 was receiving waiver services from Entity M, a personal care agency, a sister agency of Golden Heart Health Services. 410 IAC 17-12-2(g)

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 agency failed to provide visit schedules including frequency of the visits of the home health aide according to the most updated plan of care in 1 of 3 home visits. (Patient #6) Findings Include: During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, when queried about the patient’s schedule of the frequency of visits that would be provided by the home health aides, the patient stated not having a schedule. During this time, the home health aide, Employee O, in patient #6's home also confirmed there was not a schedule of home health aide visits in the home. During a phone interview on 10/10/26/21 at 11:55 AM Person J, the family member, confirmed the patient #6 had not received a home health aide schedule from the agency.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered 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 agency failed to ensure a medication list was provided to the patient in 1 of 3 home visits completed. (Patients #6) Findings Include: 1. Review of an undated agency policy titled, “Medication Profile” policy number C-700 indicated, “Policy: The Registered Nurse... will complete a medication profile for each client at the time of admission. The medication profile shall include all prescription and nonprescription drugs, including regularly scheduled medication and those taken intermittently or as needed, The profile will be reviewed and updated as needed to reflect the current medication the client is taking. Purpose: To provide a complete list of ALL medications the client is taking and an evaluation of the client’s knowledge of the effects of these medications…Special Instructions…11. The original Medication Profile shall be filed in the clinical record. A copy shall be retained by the Registered Nurse or staff member or placed in the client’s home chart when extended hours of service are being provided. 12. Medication profiles created through electronic point of care documentation systems will have a copy in the client record and client’s home…” 2. During a home visit at patient #6’s home on 10/22/21 at 11:10 AM, when queried about the patient’s medication list or a plan of care that included the medication list, Patient #6 indicated not having a medication list. Employee O, the home health aide, also confirmed there was no medication list or a plan of care in the home of patient #6. During a phone interview on 10/22/21 at 1:18 PM, Person J, a family member, confirmed they had not been given a medication list or a plan of care with medications listed. Person J stated, "We couldn't count on them setting up [his/her] medications to ensure [sic patient #6] got them on time. We had to order the preset packs to make sure [sic patient #6] gets medications. I made [sic patient #6] a medication list." These findings were reviewed with Employee A ( the only member of the Governing Body), Administrator, Alternate Administrator, and Director of Clinical Services on 10/22/21 at 4:05 PM, in which Employee A stated, “We were supposed to.”

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 interview, the agency failed to ensure all patients were provided with a copy of written instructions outlining the name and contact information of the home health clinical manager/ director of nursing for 1 out of 3 home visits. (Patient #6) Findings include: 1. Review of an undated agency policy titled, “Client/Caregiver Education” policy number C-400 indicated, “Policy: Clients and their caregivers will be provided with the information necessary…Purpose: To assure the client has adequate information to communicate effectively with agency representatives and other health providers…" 2. During a home visit at patient #6's home on 10/22/21 at 11:10 AM, the patient and Employee O, home health aide, were asked if they knew who the clinical manager was at the agency in case they had any issues, both denied knowing who the clinical manager was. Employee O, the home health aide, further indicated not knowing who the nurse was for patient #6. During a phone interview on 10/22/21 at 1:18 PM, Person J, a family member, confirmed not knowing who the clinical manager was if [he/she] had any issues.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to use measurable indicators to improve outcomes, patient safety, and quality of care (G 642;) failed to use data derived from OASIS (Outcome and Assessment Information Set) assessments to monitor services and quality of care, and failed to obtain governing body approval for the frequency and detail of data collection (G 644;) failed to ensure the QAPI (Quality Assessment and Performance Improvement) program focused on high-risk, high-volume, or problem-prone areas (G 648;) failed to document the agency had considered the incidence, prevalence, and severity of problems to select indicators and performance improvement efforts (G 650;) failed to ensure performance improvement activities documented correction of identified problems related to the health and safety of patients (G 652;) failed to ensure the agency tracked and analyzed adverse patient events and implemented actions to prevent adverse events. (G 654;) failed to measure and track performance improvement projects to determine if improvement occurred and was sustained. (G 656;) failed to ensure the QAPI (Quality Assurance Performance Improvement) Program included at least 1 performance improvement project, either in development or ongoing, that was based on the agency's QAPI program activities and data obtained through tracking, measuring, and analyzing high-risk, high-volume, problem-prone areas (G 658;) and failed to document governing body oversight of an ongoing program for quality improvement to include a requirement to identify and address possible fraud or waste (G 660.) The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate services which could result in the agency not providing quality health care, thus resulting in non-compliance with Condition of Participation CFR 484.65 Quality Assessment/Performance Improvement. Findings include: On 10/22/21 at 11 AM, employee A (the agency owner and only member of the governing body) was asked for the documentation of the QAPI program in its entirety (raw data, aggregated data, indicators, OASIS audits, performance improvement plans, goals, and tracking/follow-up, governing body oversight) for the year 2021. On 10/22/21 at 3:16 PM, employee A provided 6 documents individually titled "Plan of Correction," and each indicated a problem with a correction plan. The documents failed to include indicators used to determine the problem, who was the responsible person for the correction plan, how the plan was implemented, the follow-up necessary to determine improvement, and whether improvement was sustained. At this time, employee A was queried as to whether there was further information available that supported the agency's current QAPI program, including but not limited to tracking/audit information, statistics, goals, indicators, follow-up, governing body minutes for oversight and approval of the frequency and detail of data collection, or QAPI committee minutes. Employee A indicated all QAPI information had been provided and stated, "That's all there is. I have a book somewhere, but I can't find it." The agency failed to establish, maintain, evaluate, and implement a data-driven and agency-wide QAPI program.

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 staff implemented standard precautions, including hand hygiene, and bag technique in 2 of 3 home visits. (Patients #4, 6) Findings Include: 6. During a home visit on 10/22/21 at 10:25 AM, for patient #6, Employee O, a home health aide, was observed giving patient #6 a shower. Employee O answered the door with gloves on and was wearing a cloth mask. The home health aide failed to perform hand hygiene and don new gloves before assisting patient #6, who was sitting in a shower chair in the shower. Employee O was observed to wash the patient’s back then handed the washcloth back to the patient. The patient continued to wash the chest, arms, and peri area and used a handheld shower to rinse. Employee O was observed using the same washcloth without changing the washcloth to wash the patient’s legs and feet. Employee O was observed without performing hand hygiene and donning new gloves applying soap to the patient’s hair then handed the handheld shower to the patient to rinse hair. Observed Employee O go to the bathroom sink to rinse the soap off gloved hands. Employee O used the handheld shower to assist the patient with rinsing hair. Employee O then went to the bathroom sink and rinsed gloved hands. Employee O then moved the patient’s walker closer to the patient and handed the towel to the patient without performing hand hygiene and donning new gloves after touching the walker. Employee O was observed applying baby oil to the patient’s lower extremities. Employee O opened the closet door with gloved hands reaching in a basket for socks and applied the patient’s socks without performing hand hygiene and donning new gloves. Employee O after applying oil to the patient’s hair removed gloves without performing hand hygiene. The home health aide was not observed performing hand hygiene or donning new gloves during the shower or dressing assistance observation. During an interview on 10/22/21 at 3:44 PM, the administrator and owner confirmed hand hygiene should have been completed and new gloves applied by the home health aide during patient care after touching the door and dirty items. 1. Review of an undated agency policy titled, “Standard Infection Control Procedures for Home Care” policy number N-100 indicated, “Policy: Standard precautions were developed by the Center for Disease Control and Prevention to provide the widest possible protection against transmission of infection…” 2. Review of an undated agency policy titled, “Nursing Bag” policy number N-120 indicated, “Purpose: To carry adequate supplies for home clients. To maintain supplies in clean environment…” 3. Review of an undated agency policy titled, “Hand Washing” policy number N-130 indicated, “Purpose: To prevent the spread of infection by contaminated hands. To remove soil and transient organisms from the hands and to reduce total microbial counts over time…Equipment/Supplies: Soap. Paper Towels. Water. Before Contact with clients who are susceptible to infection…After caring for a client. Before touching organic material. Before performing invasive procedures…Before and after handling dressings or touching open wounds. After handling contaminated equipment…” 4. Centers for Disease Control last updated January 2021. When to Perform Hand Hygiene. Retrieved from cdc.gov/hand hygiene/providers/index.html indicated "Use an Alcohol-Based Hand Sanitizer: Immediately before touching a patient. Before performing an aseptic task [e.g., placing an indwelling device] or handling invasive medical devices. Before moving from work on a soiled body site to a clean body site on the same patient. After touching a patient or the patient's immediate environment. After contact with blood, body fluids or contaminated surfaces. Immediately after glove removal. Wash with Soap and Water: When hands are visibly soiled. ... After known or suspected exposure to spores ... When using alcohol-based hand sanitizer: Put product on hands and rub hands together. Cover all surfaces until hands feel dry. This should take around 20 seconds. ... The CDC Guideline for Hand Hygiene in Healthcare Settings recommends: When cleaning your hands with soap and water, wet your hands first with water, apply the amount of product ... and rub your hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers. Rinse your hands with water and use disposable towels to dry. Use towel to turn off the faucet. ... Other entities have recommended that cleaning your hands with soap and water should take around 20 seconds. Either time is acceptable. The focus should be on cleaning your hands at the right time. ... When and How to Wear Gloves: Wear gloves ... when ... contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin or contaminated equipment could occur ... Change gloves and perform hand hygiene during patient care, if gloves become damaged, gloves become visibly soiled ... moving from work on a soiled body site to a clean body site on the same patient or in another .... " 5. During a home visit with patient #4 on 10/21/21/at 10:49 AM, employee C (alternate director of nursing) was observed entering the agency carrying a nursing bag. Employee C placed the bag at the kitchen table and failed to use a barrier between the bag and the surface. Employee C was observed completing hand hygiene, then entering the bag to obtain the medication profile. After completing medication set up for the patient, employee C was observed entering the nursing bag without completing hand hygiene, obtaining a stethoscope, and auscultating patient #4. Employee c was observed returning the stethoscope to the bag without cleaning it, and obtaining a blood pressure cuff. After obtaining the patient's blood pressure, employee C returned the cuff to the bag without cleaning it or completing hand hygiene. On 10/22/21 at 2 PM, employee C was interviewed via phone as to whether they had received training on bag technique. Employee C stated they were not aware there was a particular clean/dirty technique when using a nursing bag and agreed the items had not been cleaned before replacing them in the bag.

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 agency failed to ensure all home health aides had successfully completed a satisfactory training and evaluation program or a satisfactory competency evaluation program, and all aides were found to be in good standing in the state nurse aide registry (See tag G754); failed to ensure home health aide training included classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing supervised services, totaling at least 75 hours (See tag G760); failed to ensure all aides demonstrated a minimum of 16 hours of classroom training and 16 hours of supervised practical training as part of the 75 hours (See tag G762); failed to ensure documentation that demonstrated the requirements were met (See tag G766); and failed to ensure the home health aide was evaluated based on observation of performance with a patient or pseudo-patient, written examination, oral examination, or after observation of a home health aide with a patient or with a pseudopatient as part of a simulation (See tag G768) in 7 of 7 (F, K, L, M, N, O, P) home health aide personnel records reviewed; the registered nurse failed to ensure a home health aide was provided instruction of the assigned patient to ensure all services are provided and failed to ensure the aide care plan was developed specifically to the patient needs and not "per patient request" (See tag G798); failed to ensure home health aides (HHA) provided services per the plan of care (See tag G800); and failed to ensure home health aides provided hands on personal care as ordered per the plan of care (See tag G802) in 4 of 5 patient sampled records reviewed (Patients 1, 2, 3, 6). These deficient practices have the potential to affect all patients who are currently receiving home health aide services from this provider. The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with Condition of Participation 42 CFR 484.80. *

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 record review and interview, the agency failed to ensure home health aides successfully completed a home health aide training program and/or competency evaluation program for 3 of 7 home health aide records reviewed. (Employees K, L, N) Findings include: 3. Review of personnel record for Employee K, home health aide, date of hire 8/05/21 and first patient contact date of 7/07/21 failed to evidence a home health aide competency checklist. The personnel file evidenced a State of Indiana license verification with the date of verification blank identifying Employee K as a home health aide with the expiration date of 9/7/23. 4. During a home visit on 10/22/21 at 11:55 AM observed Employee L, home health aide, provide toileting assist and he/she described the techniques used to assist the patient with showering. Review of personnel record for Employee L, home health aide, hire date of 7/6/21, and first patient contact date of 7/12/21, failed to evidence completion of a home health aide program following a lapse in providing services as a home health aide. The personnel file failed to evidence a State of Indiana License with the verification blank identifying employee L as a home health aide. Review of personnel record for Employee L, evidenced he/she had not been employed as a home health aide from February of 2019 until her hire date July of 2021 and did not have an active license upon employment. During an interview with Home health aide L on 10/25/21 at 10:55 AM, he/she reported his/her home health aide license had expired, “when I started, I renewed that day.” Review of Employee L’s Home health aide license indicated a renewal date of 10/15/21. During an interview on10/25/21 at 10:55 AM, Employee L reported he/she had zero competency evaluation and had only filled out paperwork. An interview with Employee G on 10/22/21 at 3:10 PM verified that employee L did not have a competency evaluation on file and stated "we are trying to fix what was here from previous staff." 5. Review of personnel record for Home health aide N with a hire date of 6/10/21 and first patient contact of 6/19/21, failed to evidence a home health aide competency evaluation. The personnel record failed to evidence a State of Indiana License with the verification blank identifying employee N as a home health aide with an expiration of 8/9/22. 1. Review of the personnel file for employee K (home health aide or hha) evidenced a job application for entity Q (a personal services agency owned by employee A, (agency owner) and indicated employee K had no previous experience or training as a home health aide or certified nursing assistant. The file also evidenced a completed answer sheet titled "Home Health-Hospice Aide Exam" which evidenced 34 of 160 questions marked incorrectly. A completed multiple-choice test, also titled "Home Health-Hospice Exam" and dated 8/5/21, evidenced a grade of -5 and 95%. Review of the test and questions indicated the employee was given credit for incorrect answers. The personnel file failed to evidence employee K received and passed an accurately graded written test, received and passed a skills competency, or had any experience as a home health aide or certified nursing assistant. On 10/22/21 at 3:28 PM, employee K was interviewed concerning previous experience as a home health aide. Employee K stated patient #1 knew them from home and asked employee K to work weekends for the agency because the patient could not find staffing. Employee K stated they were initially employed by entity Q only, but needed more hours so they working for Golden Heart. The employee stated, "They said I could test out. They gave me the study material - they printed all the slides, then gave me a practice test which ended up being the real test. I took the test and passed." When queried as to whether employee K demonstrated hands on competency, the employee stated, "I did no hands on competency, but I'd already been doing that work with [Name of patient #1] by then. [Patient #1] taught me what to do." Employee K stated they had no previous experience as an aide, and never attended any home health aide training or certified nursing assistant school. 2. Review of the personnel file for employee N (home health aide), evidenced a document titled "Certified Home Health/Hospice Aide Check List". The document evidenced demonstrations of skills dated 6/10/19 and initialed, illegibly. The evaluator's signature was illegible, and the Home Health Aide signature was dated 6/14/19. On 10/26/21 at 9:51 AM, employee N was interviewed. Employee N stated they'd worked for the agency for about 2 years and was a home health aide prior to employment with the agency. When queried as to whether the employee demonstrated skills competencies or completed a written test as part of orientation or employment prior to providing patient care, employee N stated, "It was me and one other person. We did a bed bath on the mannequin and the nurse came out to a patient's home and observed a bed bath once, then once for a shower." The employee stated they did a written test and denied completing the skills listed on the checklist. On 10/24/21 at 11:31 AM, employee C (director of nursing) was interviewed and stated, The next day after you came [employee A] made me stay in the human resources office and audit. {Employee A] gave a whole bunch of home health aide competencies to [name of employee D, director of nursing] to sign and initial, and [employee D] did ... They had [name of employee D] sign a bunch of blank home health aide competency pages because no one had one."

Classroom and supervised practical training CFR(s): 484.80(b)(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure home health aides successfully completed a home health aide training program and/or competency evaluation program for 2 of 7 home health aide records reviewed. (Employees O and P) Findings include: 1. During a home visit on 10/22/21 at 10:25 AM, observed Employee O, home health aide, provide shower assistance, shampoo, hair care, foot care, dressing, and assist with ambulation. A review of the personnel record for Employee O, HHA (home health aide) date of hire 2/2/21, and first patient contact 4/20/21, failed to evidence a home health aide establishment of skills competency checklist. During an interview on 10/26/21 at 11:13 AM, when queried about training and competency on hire, Employee O stated, “I did not do any competency or test when I was hired. I have experience so I did not need that.” 2. A review of the personnel record for Employee P, HHA (home health aide) date of hire 4/22/21, and first patient contact 4/23/21, failed to evidence a home health aide establishment of skills competency checklist and test. The personnel file failed to evidence a State of Indiana license verification with the date of verification identifying Employee P as a home health aide. During an interview on 10/10/26/21, at 11:30 AM, when queried about missing information from personnel records, Employee G, Human Resources Coordinator, stated, “This is why I am auditing the files. It is a mess.”

Minimum hours of training CFR(s): 484.80(b)(2) A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure 5 of 7 active home health aides reviewed met the minimum requirements of 16 hours of classroom training and 16 hours of supervised training as part of the 75 hours of training. (Employees K, L, N, O, and P) Findings include: 3. Review of the personnel file for Employee K, home health aide, with a hire date of 8/05/21, first patient contact 7/07/21, failed to evidence completion of 16 hours in-class training and 16 hours of supervised training. 4. Review of the personnel file for Employee L, home health aide, with a hire date of 7/06/21, and first patient contact of 7/12/21, failed to evidence completion of 16 hours in-class training and 16 hours of supervised training. During an interview on 10/25/21 at 10:55 AM, Employee L confirmed the home health agency provided no training. 5. Review of the personnel file for Employee N, home health aide, with a hire date of 6/10/21 and first patient contact of 6/19/21, failed to evidence 16 hours in-class training and 16 hours of supervised training. 1. Review of the personnel file of Employee O, home health aide, date of hire 2/2/21, and first patient contact 4/20/21, failed to evidence completion of 16 hours in-class training and 16 hours of supervised training. During an interview on 10/26/21 at 11:13 AM, when queried about training, Employee O confirmed the agency did not provide the home health aide with any training. 2. Review of the personnel file of Employee P, home health aide, date of hire 4/22/21, and first patient contact 4/23/21, failed to evidence completion of 16 hours in-class training and 16 hours of supervised training. On 10/24/21 at 11:31 AM, employee C (director of nursing) was interviewed and stated, "The next day after you came [employee A] made me stay in the human resources office and audit. {Employee A] gave a whole bunch of home health aide competencies to [name of employee D, director of nursing] to sign and initial, and [employee D] did ... They had [name of employee D] sign a bunch of blank home health aide competency pages because no one had one."

HHA maintains documentation of training CFR(s): 484.80(b)(4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to maintain documentation home health aides had received in-class training and supervised training for 5 of 7 home health aide records reviewed. (Employees K, L, N, O, and P) Findings include: 3. A review of skills competency and classroom training for Employee K, home health aide, with a hire date of 8/05/21, first patient contact 7/07/21, failed to evidence documentation of completion of 16 hours in-class training and 16 hours of supervised training. 4. A review of skills competency and classroom training for Employee L, home health aide, with a hire date of 7/06/21, first patient contact of 7/12/21, failed to evidence documentation of completion of 16 hours in-class training and 16 hours of supervised training. 5. A review of skills competency and classroom training for Employee N, home health aide, with a hire date of 6/10/19, first patient contact of 6/14/19, failed to evidence documentation of 16 hours in-class training and 16 hours of supervised training. 5. A review of skills competency and classroom training for Employee O, home health aide, with a hire date of 2/2/21, first patient contact of 4/20/21, failed to evidence documentation of completion of 16 hours in-class training and 16 hours of supervised training. 6. A review of skills competency and classroom training for Employee P, home health aide, with a hire date of 4/22/21, first patient contact of 4/23/21, failed to evidence documentation of completion of 16 hours in-class training and 16 hours of supervised training. During a phone interview on 10/25/21 at 10:55 AM, when queried about agency training and completion of supervised training Employee L, a Home Health Aide confirmed did not receive any training. During an interview on 10/26/21 at 11:15 AM, when queried about completion of training, Employee O, a Home Health Aide stated, “I have experience I did not do any tests of skills training.” The findings were reviewed with Employee A (the only member of the Governing Body), Administrator, Alternate Administrator, and Director of Clinical Services on 10/26/21 at 2:55 PM, in which they had no further information or documentation to provide. 1. Review of undated agency policy D-220, titled "Competency Evaluation of Home Care Staff", evidenced "All competencies will be documented" and "Documentation of individual Home Health Aide training and/or competency shall be maintained in the ... personnel file." 2. Review of undated agency policy D-180, titled "Personnel Records" evidenced "The personnel file shall include competency testing for home health aides." On 10/20/21 at 11:31 AM, employee C (alternate director of nursing) was interviewed concerning documentation in the personnel files. Employee C stated, "The next day after you came [employee A] made me stay in the HR (Human Resources) office and audit. [Employee A] gave a whole bunch of hha (home health aide) competencies to [Name of employee D] to sign and initial, and [he/she] did. They had [Name of employee D] sign a bunch of blank hha competency pages because no one had one." On 10/22/21 at 3:28 PM, employee K (an hha), was interviewed concerning training to become a home health aide. Employee K stated they were originally hired for the waiver agency but needed more hours so the agency provided the employee with the slides from the aide training program and the written hha test to use for practice. Employee K stated they did the same written test as the final test but did no skills competency and no classroom study other than the review of the power point slides. On 10/25/21 at 9:30 AM, employee D was interviewed concerning the aide training classes. Employee D stated they went to a patient's home with the training class and stated no one ever did full bathing for the competency. Students took turns doing different tasks all at one home. For example, a person would wash the upper half of a patient, and another person would wash the lower half. However, the individuals that arrived for orientation didn't do a bath, ever. Sometimes the employee would do "a few things on the mannequin" but during orientation, employee D was unable to determine who was hired as a personal service attendant and who was hired as a home health aide. On 10/26/21 at 9:51 AM employee N was interviewed and stated they worked for the agency for 2 years, and was an hha prior to this agency. When queried concerning orientation, employee N stated they had no orientation or skills competency. Employee N stated they "came in, went over paperwork, did a bed bath on the mannequin and the nurse observed the employee do a bed bath in and shower in a patient home. They also completed a written test.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to implement its own policies to ensure home health aides who had provided patient care, had successfully completed a competency evaluation program which addressed communication skills, observation/reporting/ documentation of patient status and care, reading/recording of basic vital signs (temperature, pulse, respiration), basic infection control, basic elements of and changes in body functioning that must be reported, maintenance of a healthy environment, recognizing emergencies and when to institute emergency procedures, the physical/ emotional/developmental needs and care of patients, patient respect, appropriate and safe performance of personal hygiene and grooming (including bed, sponge, shower, and tub bath; shampoo in sink, tub, and bed; nail and skincare; oral hygiene; toileting and elimination), safe transfer and ambulation, range of motion and proper positioning, adequate nutrition and fluid intake, and recognizing and reporting skin condition in 7 of 7 active home health aides (HHA). (Employees F, K, L, M, N, O, P) Findings include: Review of establishment of skill competency for employee K with date of hire 8/05/21 date of first patient contact 7/07/21 failed to evidence documentation of completion of skills competency for reading, recording, temperature, pulse and respirations, appropriate safe technique in performing personal hygiene, safe transfer and techniques in ambulation. Review of establishment of skills for employee L, with a date of hire 7/06/21, date of first patient contact 7/06/21 failed to evidence documentation the home health aide establishment of skills and competency included the reading, recording, temperature, pulse, and respirations, appropriate safe technique in performing personal hygiene, safe transfer and techniques in ambulation. A review of home health aide L’s employment record evidenced he/she had not been employed as a home health aide from February of 2019 until her hire date July of 2021 and did not have an active license upon employment. During an interview with home health aide L on 10/25/21 at10:55 AM, he/she reported his/her home health aide license had expired, “when I started, I renewed that day” and reported he/she had zero orientation, skills testing, and had only filled out paperwork. A review of Employee L’s license indicated a renewal date of 10/15/21. Review of establishment of skills for employee N, date of hire 06/10/19 date of first patient contact 06/14/19 failed to evidence documentation of completion of skills and competency included the reading, recording, temperature, pulse, and respirations, appropriate safe technique in performing personal hygiene, safe transfer and techniques in ambulation. Review of the establishment of skill competency for Employee F with the date of hire 6/18/18, date of first patient contact 6/21/21, failed to evidence documentation of completion of skills competency for reading, recording, temperature, pulse and respirations, the appropriate safe technique in performing personal hygiene, safe transfer and techniques in ambulation. Review of the establishment of skill competency for Employee M with the date of hire 10/14/20, date of first patient contact 11/9/21, failed to evidence documentation of completion of skills competency for reading, recording, temperature, pulse and respirations, the appropriate safe technique in performing personal hygiene, safe transfer and techniques in ambulation. Review of the establishment of skill competency for Employee O with the date of hire 2/2/21, date of first patient contact 4/23/21, failed to evidence documentation of completion of skills competency for reading, recording, temperature, pulse and respirations, the appropriate safe technique in performing personal hygiene, safe transfer and techniques in ambulation. During an interview on 11/26/21 at 11:15 AM, when queried about skills competency and completion of training Employee O stated, “ I have experience I did not do any tests of skills training.” 1. Review of undated agency policy B-115, titled “Competency Assessment” evidenced “All employees will complete a self-assessment of the skills area for their job description." 2. Review of undated agency policy B-150, titled “Employee Orientation” evidenced “Home Health Aides will complete competency testing prior to providing client care. (Home Health Aide competency program or test per Medicare guidelines.)” and “All employees will be assessed for competency prior to providing care.” 3. Review of undated agency policy/job description C-140, titled “Position: Home Health Aide”, evidenced qualifications for the home health aide which included “Successful completion of a formal certification training program and/or written skills test and competency evaluation.” 4. Review of undated agency policy C-220, titled “Home Health Aide Services” evidenced “All individuals providing home health aide services will be qualified through training and/or competency evaluations." 5. Review of undated agency policy D-145, titled “Competency Evaluation – Home Health Aide” evidenced a checklist for the onsite evaluation of skills, which listed 73 items to be observed, including, but not limited to, communication skills/human behavior and working with people, observation, reporting, and documentation of patient status and the care or service furnished, reading and recording vital signs, basic infection control procedures, client rights, adequate nutrition, etc. 6. Review of undated agency policy D-175, titled “Home Health Aide Skills Checklist” evidenced “The following information will aid the supervisor in providing individual learning situations and special classes for the home health aide (HHA) and will assist in evaluating the current training/in-service programs.” The checklist provided a rating key of 1-Can safely perform without supervision, 2- Needs demonstration and/or practice, and 3- Needs basic instruction. The document listed 133 areas of evaluation, which included, but were not limited to: hand washing, infection control theory, bed bath, sponge bath, tub bath, tub bath with tub bench, shower, shower with bench, identify pressure points, bed positioning, mouth care, shaving, hair care, nail care, assist with clothing, bed making, use of urinal, routine catheter care, vital signs, perineal care, use of body mechanics, transfers, etc. 7. Review of undated agency policy D-150, titled “Home Health Aide Competency Evaluation Record” evidenced a document that listed the date, name, and position of the employee, and the written test score and performance evaluation score. The document listed written evaluation categories tested including communication skills, observation, reporting, documentation, infection control, client rights, adequate nutrition, and fluid intake, etc. The document also listed performance evaluation categories tested including, but not limited to, reading and recording vital signs, techniques in personal hygiene, safe transfer and ambulation, and range of motion and positioning. A section at the bottom evidenced “Competency evaluation completed by: … " and provided an area for an RN signature and date showing when the competency evaluation was completed. 8. Review of undated agency policy D-220, titled “Competency Evaluation of Home Care Staff” evidenced “The agency will establish a program that allows for objective, measurable, assessment of the person’s ability to perform required activities. Individuals working in the agency must be licensed, registered or certified as required by law, policy or standards of practice … All competencies will be documented … “The policy also evidenced “All new employees will be assessed for competency based on the expected requirements for the position.” In a section titled “Home Health Aide Competency” the policy evidenced “2. The skills competency is evaluated by observing the aide with client or ‘pseudo’ client (not a manikin [sic]). 3. A Home Health Aide will not be permitted to provide Home Health Aide services until evidence of adequate training and/or competency has been determined by the designated professional in the agency.” The policy specified “4. The Home Health Aide must demonstrate evidence of a. Successful completion of a training program totaling at least seventy-five (75) hours. At least sixteen (16) of those hours must have been devoted to supervised practical training. OR b. Successful completion of a competency evaluation program. The Home Health Aide will have successfully completed the competency evaluation program if he/she demonstrates competency in a minimum of eleven (11) of the twelve areas required in federal guidelines.” The required topics for competency evaluation included communication skills, observation/reporting/documentation, reading/recording temperature/pulse/respiration*, basic infection control, basic elements of body functioning and changes, maintenance of a clean/safe/healthy environment, recognizing emergencies, physical/emotional/developmental needs of the client, including respect for the client and his/her property, appropriate techniques in personal hygiene and grooming (specified as bed bath, sponge/tub/or shower bath, shampoo in sink/tub/or bed, nail and skin care, oral hygiene, toileting and elimination), safe transfer and ambulation*, normal range of motion and positioning*, and adequate nutrition and fluid intake. Items with an * were qualified with “Note: Subject areas with an * must be evaluated after observation of the Home Health Aide’s performance of the tasks with a client. The other subject areas may be evaluated through written examination, oral examination, and/or after observation of a Home Health Aide with a client.” 9. Review of undated/un-numbered agency policy titled “Evaluating Competence in Home Care” evidenced “All employees must be qualified for each assignment … Agencies must assess competencies needed for staff that works in the Agency … the supervisor must be confident in the individual’s ability before completing the orientation period.” Performance areas for home health aides listed 9 categories, which included: communicates effectively with clients and coworkers, reports changes to the nursing supervisor or scheduler, provides personal care including bathing, dressing and ambulation, and follows infection control techniques. 11. Review of undated, un-numbered agency policy titled “Competency Evaluations” evidenced “Home Health Aide: Unlicensed professionals that will provide direct client care must demonstrate their competency during the orientation program and according to the Agency skills checklist and activities delineated in the competency testing required by CMS (Centers for Medicare and Medicaid) and state-specific guidelines. 12. Review of the personnel file for employee K (Home Health Aide or hha) evidenced an application showing position applied for was checked as “caregiver." The HHA and CNA (Certified Nursing Assistant) options were blank. The application evidenced no prior work history in the fields of caregiving, hha/CNA services, or direct patient care. Review of an untitled information form revealed a section designated to be completed by the employer and included a date of hire for employee K of 8/5/21, Job titled “Caregiver. GHC (Golden Heart Caregivers) was checked. GHHS (Golden Heart Healthcare Services) was blank. The file contained a “Home Health-Hospice Aide Exam Answer Sheet” dated 8/5/21, which evidenced 37 of 160 (21 %) marked incorrect (an X to the side), but failed to evidence a total score, or whether employee K passed or failed. Further review evidenced a “Home Health-Hospice Exam” dated 8/5/21, which included 160 multiple choice questions and indicated a score of “-5, 95%” but failed to evidence supervision by a qualified RN, and which test was used to determine final competency as an hha. The personnel file evidenced hha license verification, undated, with an employee date of hire of 8/5/21, and an hha license issue date of 9/7/21, via examination. The record failed to evidence a competency checklist or evidence that employee K demonstrated any patient care tasks as required by agency policies. The personnel file failed to evidence an hha job description for employee K, or that employee K completed a CNA or hha training program, or accurately completed a written and practical aide competency in all categories required, and under the supervision of a qualified RN. 13. On 10/18/21 at 12:57 PM, individual L (a relative of patient #1) was interviewed concerning services for patient #1. Individual L stated patient #1 had to recruit his/her own staff to work for the agency because the agency couldn’t provide adequate staffing, and the aides weren’t qualified for the kind of care patient #1 needed. Individual L stated patient #1 was dropped by an aide because the aide didn’t know how to care for patient #1. Individual L stated the patient’s current weekend aide … “went through the training online but that’s it.” On 10/18/21 at 1:22 PM, patient #1 was interviewed concerning services. The patient stated he/she had been dropped approximately 6 months ago because employee P, a previous hha, was not qualified to provide care. Patient #1 stated they found a college student (Employee K) who now provided the patient’s weekend shifts, but after the first week, employee K spoke with the agency owner and administrator due to concerns because employee K had “never done this kind of work before.” On 10/20/21 at 11:31 AM, employee C (Alternate Director of Nursing) reported witnessing employee A (agency owner) give employee D (Director of Nursing) “a whole bunch of home health aide competency documents to complete and sign.” Employee C confirmed witnessing the documents were being filled out and placed in employee files at that moment, because the agency did not complete written testing or skills demonstration for competency for home health aides prior to employment or first patient contact. Employee C stated, “They had [Name of employee D] sign a bunch of blank home health aide competency pages because no one [home health aide personnel files] had one.” On 10/22/21 at 3:28 PM, employee K was interviewed. Employee K stated he/she was initially employed only for the personal services agency, not by the home health agency, but requested more hours and was moved to the home health agency. When queried concerning whether the employee completed an application or orientation for the Golden Heart Healthcare, or whether employee K completed a written competency test and an establishment of skills competency for a home health aide, Employee K stated “they made me take a test and said I could test out. They gave me the study material – they printed all the slides, then gave me a practice test, which ended up being the real test, so when I took the test, I passed. I did no hands-on competency. But I’d already been doing that work with [Name of patient #1].” Employee K confirmed no previous experience as an hha or CNA and never having attended an aide training program or CNA program prior to or during employment with Golden Heart. Employee K stated, “[Name of patient #1] taught me how to provide the care.” Employee K denied ever being observed by an RN (Registered Nurse) while providing care for a patient or pseudo- patient. On 10/25/21 at 9:30 AM, employee D was interviewed concerning the home health aide competency prior to employment and/or direct patient care and the home health aide training class/program provided by the agency. Employee D stated that former employee S, a non-clinical individual, was responsible for the training in the home health aide training program and it was the agency practice for an RN to take a training class as a group to one patient’s home, where the students would take turns doing different tasks. One person would wash the patient’s upper half, and one would do the lower half, one would transfer the patient, etc. Employee D stated that employees coming in for orientation “didn’t do a bath, ever. Sometimes we did a few things with the mannequin. Orientation would have both PSA (Personal Service Agency) side and HHC (Home Health Care) side. It was a lot for me to try to figure out who and what company I was orienting.” On 10/25/21 at 12:16 PM, former employee P (hha) was interviewed concerning her orientation and competency experience with the agency. Employee P confirmed receiving orientation the day before beginning work with patient #1. The employee stated, “We did new hire paperwork, talked about some policies, talked about the schedule. I had no hands-on competency.” Employee P denied completing a written competency test. On 10/26/21 at 9:51 AM, employee N (hha) was interviewed concerning employment and orientation with the agency. Employee N stated, “I didn’t have one at all. I came in, went over paperwork. That’s it. It was me and one other person did a bed bath on the mannequin.” Employee N stated the RN (registered nurse) observed them providing a bed bath and a shower on an actual patient once, as well as a transfer from bed to chair and chair to tub, but nothing else. Employee P stated, “… others didn’t have to do that.”

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 record review and interview, the registered nurse failed to ensure a home health aide was provided instruction of the assigned patient to ensure all services are provided and failed to ensure the aide care plan was developed specifically to the patient needs and not "per patient request" for 3 of 6 record review of patients who received home health aide services. (Patients #1, 2, 3, 6) Findings include: 3. The clinical record for Patient #1 was reviewed and contained a plan of care for the certification period of 9/1/21 - 10/30/21 with orders for home health aide services 7 – 16 hours/ day, 5 – 7 times a week for 9 weeks under Medicaid PA (prior authorization) to assist with ADL’s/ IADL’s [activities of daily living which consist of basic self-care tasks like bathing, ambulation, meals/ Instrumental activities of daily living which consist of housekeeping and preparing meals] per the home health aide care plan. A review of the aide care plan dated 9/1/21 revealed instructions for the aide to take temperature, provide hair care, shampoo, skin care, dressing, and take the trash out each visit and to do light laundry, change bed linen, light housekeeping, clean equipment, dust, sweep, and vacuum weekly. All duties indicated under the “special note: per patient request”. The aide care plan failed to evidence that all services to be provided were specific to the patient's needs and not “per patient request.” 4. The clinical record for Patient #2 was reviewed and contained a plan of care for the certification period of 6/30/21 to 8/28/21 with an order for home health aide services 13 hours a day 7 days a week for 9 weeks to assist with ADL’s/ IADL’s per the home health aide care plan. Review of the Home Health Aide care plans, effective 5/1/21, 7/2/21, evidenced the aide should obtain a temperature, hair care, shampoo, skin care, mouth/ denture care, foot care, nail care, dressing, light laundry, bed linen change, make bed, light housekeeping in the bedroom, bathroom, and kitchen, dust, sweep, vacuum, prepare a meal, personal care, shower, and sponge bath up in a chair. All duties are indicated under the “special note: per patient request.” The aide care plan failed to evidence that all services to be provided were specific to the patient's needs and not “per patient request.” 5. The clinical record for Patient #3 was reviewed and contained a plan of care for the certification period of 8/30/21 - 10/28/21 with orders for home health aide services 9 hours/ day, 5 times a week for 9 weeks under Medicaid PA to assist with ADL's/IADL's per the home health aide care plan. Review of the Home Health Aide care plan, effective 8/31/21, evidenced the aide should obtain a temperature, assist with a walker, and encourage fluids each visit; hair care, skin care, mouth care, foot care, nail care, dressing, light laundry, make the bed, light housekeeping, trash, personal care, shower, and sponge bath, shampoo, lining change, dust, sweep, and vacuum. All duties are indicated under the “special note: per patient request.” The aide care plan failed to evidence that all services to be provided were specific to the patient's needs and not “per patient request.” 6. The clinical record for Patient #7 was reviewed and contained a plan of care for the certification period of 8/22/21 - 10/20/21, with orders for home health aide services 9 hours/ day, 5 times a week for 9 weeks under Medicaid PA to assist with ADL's/IADL's per the home health aide care plan. Review of the Home Health Aide care plan, effective 8/22/21, evidenced the aide should obtain a temperature, hair care, shampoo, skin care, mouth care, foot care, nail care, dressing, light laundry, make the bed, light housekeeping, trash, personal care, shower, and sponge bath, shampoo, lining change, dust, sweep, vacuum, prepare a meal, personal care, shower, sponge bath up in a chair. All duties are indicated under the “special note: per patient request.” The aide care plan failed to evidence that all services to be provided were specific to the patient's needs and not “per patient request.” 7. On 10/18/21 at 9 AM, employee A (agency owner) and employee C (alternate director of nursing) were interviewed concerning the ordered frequency and tasks on the medical and aide care plans. When queried as to how a frequency was determined for a patient, employee C stated, "CICOS (Area Agency on Aging and Disability) tells us. And the patient also tells us" and employee A stated, "The doctor ultimately approves." When queried as to why the majority of tasks ordered on the aide plan of care were "per patient request" and were not patient-specific and/or individualized for each patient, employee C stated, "Well it just depends on whatever the patient needs." Employee A stated, "If they don't tell us, we just start suggesting. You kind of have to suggest things to do. The aide will call and notify if they refuse." When asked for documentation related to refusal of tasks for patients #1 and 3, employees A and C confirmed there was none available. 1. Review of an undated agency policy titled, “Home Health Aide Care Plan” policy number C-751 indicated, “Policy: A complete and appropriate Care Plan, identifying duties to be performed by the Home Health Aide, shall be developed by a Registered Nurse... All home health aide staff will follow the identified plan. The Care Plan will be available to all persons involved in client care including contract providers. Purpose: To provide a means of assigning duties to the Home Health Aide that are clear to the Nurse, Home Health Aide, and to the client/caregiver being served. To provide documentation that the supervising Nurse oriented the assigned Aide to the client’s care before initiating the care. To provide documentation that the client’s care is individualized to his/her specific needs…” 2. During a home visit at patient #6’s home on 10/22/21 at 10:30 AM, Employee O, HHA (home health aide) was observed assisting patient #6 with a shower and washing patient #6's hair. After the shower, Employee O was observed assisting patient #6 with ambulation using a walker to her bedroom, assisted with dressing, and applying oil to patient 6’s hair. During this time, when queried about an aide care plan to review, Employee O confirmed not having been provided with an aide care plan and not knowing who the nurse was. The clinical record for Patient #6 was reviewed and contained a plan of care for the recertification period of 10/17/21 to 12/15/21, with orders for HHA visits 2-9 hours per day, 2-7 times a week, for 9 weeks, to provide assistance with personal care and assistance with ADL’s (Activities of Daily Living). A review of the aide care plan dated 8/18/21 indicated patient’s diet was low sodium, the patient lived alone, needed assistance for major ADL’s (Activities of Daily Living), SOB (short of breath) on exertion, confusion, and forgetful, up as tolerated, poor vision, has upper and lower dentures, and the patient was allergic to smoke please change clothes before entering and wash hands. The aide care plan also revealed the aide should obtain a temperature, hair care, shampoo, skin care, mouth/denture care, foot care, nail care, dressing, light laundry, bed linen change, make bed, light housekeeping in the bedroom, bathroom, kitchen, clean equipment, sweep, vacuum, take out the trash, prepare meals, personal care, shower M/W/F, sponge bath up in the chair, ambulation devices to use was walker and cane. All duties are indicated under the “special note: per patient request.” The aide care plan failed to evidence that all services to be provided were specific to the patient's needs and not “per patient request.”

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 agency failed to ensure home health aides (HHA) provided services per the plan of care for 3 of 3 active complete records reviewed of patients receiving home health aide services. (Patients #1, 3, 6) Findings include: 3A. During a home visit with Employee O, HHA, on 10/22/21 at 10:30 AM, Employee O was observed giving patient #6 a shower. After the shower, the home health aide assisted with ambulation with the patient's walker to the bedroom, assisted with dressing, applying lotion to lower extremities, applied oil to patient 6’s hair. During this time, when queried about what the HHA used to direct care tasks, such as an aide care plan, Employee O confirmed was just filling in with patient #6, this was Employee O's 2nd or 3rd visit, and the agency did not provide Employee O, HHA with a report or an aide care plan for patient #6. The clinical record for patient #6 was reviewed and contained a plan of care for the recertification period of 10/16/20 to 12/14/20, indicated, a home health aide 2-9 hours/day, 2-7 days a week, for 9 weeks, to provide assistance with personal care and assistance with ADLs (Activities of Daily Living). A review of the home health aide visit notes revealed the home health aide failed to provide 8 hours of services per day, 5 days a week as evidenced by the following: For the week of 8/22/21 to 8/28/21, failed to evidence the patient was provided 8 hours of care on 8/24/21 and 8/25/21. No services were provided on the weekend, therefore, the patient failed to receive services 5 days during this week. For the week of 9/5/21 to 9/11/21, failed to evidence the patient was provided 8 hours of care on 9/6/21 and a missed visit on 9/7/21. No services were provided on the weekend, therefore, the patient failed to receive services 5 days during this week. For the week of 9/12/21 to 9/17/21, failed to evidence the patient was provided 8 hours of care on 9/13/21; a missed visit on 9/14/21; failed to evidence the patient was provided 8 hours of care on 9/15/21; and a missed visit on 9/17/21. No services were provided on the weekend, therefore, the patient failed to receive services 5 days during this week. For the week of 9/19/21 to 9/25/21, failed to evidence the patient was provided 8 hours of care on 9/20/21; 9/21/21; 9/22/21; 9/24/21; and 9/23/21. For the week of 9/26/21 to 10/2/21, failed to evidence the patient was provided 8 hours of care on 9/27/21; 9/28/21; 9/29/21; 9/30/21; and the patient was provided with no care on 10/1/21. No services were provided on the weekend, therefore, the patient failed to receive services 5 days during this week. For the week of 10/3/21 to 10/9/21, failed to evidence the patient was provided 8 hours of care on 10/4/21; 10/5/21; 10/6/21; 10/7/21, and 10/8/21. For the week of 10/10/21 to 10/16/21, failed to evidence the patient was provided 8 hours of care on 10/11/21; 10/12/21; 10/24/21; 10/15/21; and a missed visit on 10/13/21. No services were provided on the weekend, therefore, the patient failed to receive services 5 days during this week. During an interview on 10/22/21 at 12:43 PM, Person K, a family member, stated “We have not been happy with staffing. [Name of Patient #6] is supposed to have 8 hours a day Monday thru Friday and 4 hours on Saturday. They tell us it is going to be better, and it is not. We worry about [Name of Patient #6] falling and while we are all at work.” A review of physician orders failed to evidence that the physician had ordered any change in patient #6's services during the certification period. 3B. A review of the aide care plan with the effective date 8/18/21, indicated the patient was allergic to smoke please change clothes before entering home and wash hands, diet low sodium, alone, needs to assist for major, ADLs, short of breath) on exertion, confusion/forgetful, has lower and upper dentures, poor vision, up as tolerated, hair care, shampoo, mouth/ denture care, foot care, dressing, make the bed, lighthouse keeping bedroom, bathroom, kitchen, clean equipment, vacuum, take out the trash, sweep, prepare meals, bathing personal care, shower, medication reminders, assist with ambulation cane and walker all with per patient request. Review of a home health aide note dated 8/25/21, from 2:00 PM to 5:00 PM, failed to indicate the aide provided hair care, shampoo, mouth/ denture care, foot care, dressing, make the bed, lighthouse keeping bedroom, bathroom, kitchen, clean equipment, vacuum, bathing personal care, shower, medication reminders, and assistance with ambulation cane and/or walker. The home health aide failed to provide all ADL tasks as ordered per the plan of care. Review of a home health aide note dated 9/29/21, with no time in or out recorded, failed to indicate the aide provided hair care, shampoo, mouth/denture care, foot care, dressing, make the bed, clean equipment, bathing personal care, shower, medication reminders, and assistance with ambulation cane and/or walker. indicated the aide. The home health aide failed to provide all ADL tasks as ordered per the plan of care. Review of a home health aide note dated 10/11/21, from 3:00 PM to 5:00 PM, failed to indicate the aide provided hair care, shampoo, mouth/denture care, foot care, dressing, make the bed, bathroom, kitchen, clean equipment, vacuum, bathing personal care, shower, and assistance with ambulation cane and/or walker. The home health aide failed to provide all ADL tasks as ordered per the plan of care. Review of a home health aide note dated 10/14/21, from 3:00 PM to 5:00 PM, failed to indicate the aide provided hair care, shampoo, mouth/denture care, foot care, dressing, make the bed, lighthouse keeping bedroom, bathroom, kitchen, clean equipment, vacuum, bathing personal care, shower, medication reminders, and assistance with ambulation cane and/or walker. The home health aide failed to provide all ADL tasks as ordered per the plan of care. Review of a home health aide note dated 10/12/21, from 3:00 PM to 5:00 PM, failed to indicate the aide provided hair care, shampoo, mouth/denture care, foot care, dressing, make the bed, clean equipment, vacuum, bathing personal care, shower, medication reminders, and assistance with ambulation cane and/or walker. The home health aide failed to provide all ADL tasks as ordered per the plan of care. Review of a home health aide note dated 10/14/21, from 3:00 PM to 5:00 PM, failed to indicate the aide provided hair care, shampoo, mouth/denture care, foot care, dressing, make the bed, lighthouse keeping bedroom, bathroom, kitchen, clean equipment, vacuum, bathing personal care, shower, medication reminders, and assistance with ambulation cane and/or walker. The home health aide failed to provide all ADL tasks as ordered per the plan of care. During an interview on 10/22/21 at 11:00 AM Employee O, home health aide confirmed not having a home health aide care plan to guide HHA tasks, and stated, " I have no idea who the nurse is for patient #6." 1. The clinical record of Patient #1 was reviewed and evidenced a plan of care dated 9/1/21 - 10/30/21 which indicated orders for "HHA (home health aide or hha) 7-16 hours/day x 5-7 days/week x 9 weeks, to assist with ADL's and IADL's [activities of daily living which consist of basic self-care tasks like bathing, ambulation, meals/ Instrumental activities of daily living which consist of housekeeping and preparing meals] per the hha care plan. The plan of care failed to evidence that the patient’s hours were to be divided into 3 shifts. The home health aide failed to follow the plan of care as evidenced by the following: A review of the aide care plan, effective 9/1/21, indicated the following duties to be completed by the home health aide: temperature, prepare a meal, check for pressure points, toileting/hygiene, assist with wheelchair and BSC (bedside commode) each visit; hair care, shampoo, skin care, dressing, light housekeeping, trash removal each visit per patient request; light laundry, bed linen change, clean equipment, dust, sweep, vacuum weekly per patient request. A review of the visit note dated 9/20/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, shampoo, skin care, shower, meal, and if any housekeeping duties were completed besides laundry. A review of the visit note dated 9/20/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, shower, checking pressure points, toileting/ hygiene, and if any light housekeeping duties were completed beside the trash. A review of the visit note dated 9/21/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, shampoo, skin care, shower, meal, and if any housekeeping duties were completed besides the trash. A review of the visit note dated 9/21/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, shampoo, dressing, personal care, shower, meal, and if any light housekeeping duties were completed beside the trash. A review of the visit note dated 9/21/21 from 10:00 PM to 9/22/21 at 7:30 AM; failed to evidence a temperature, shampoo, skin care, shower, meal, and if any housekeeping duties were completed beside the trash. A review of the visit note dated 9/22/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, hair care, shampoo, shower, meal, and if any housekeeping duties were completed besides the trash. A review of the visit note dated 9/22/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, hair care, shampoo, dressing, shower, meal, and if any light housekeeping duties were completed. A review of the visit note dated 9/22/21 from 10:00 PM to 9/23/21 at 7:30 AM; failed to evidence a temperature, if the patient had hair care, shampoo, dressing, personal care, shower, meal, and if any housekeeping duties were completed. A review of the visit note dated 9/23/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, shampoo, dressing, personal care, shower, meal, bed linen change, and if any housekeeping duties were completed besides the trash. A review of the visit note dated 9/23/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, shampoo, skin care, dressing, personal care, shower, meal, and if any light housekeeping duties were completed. A review of the visit note dated 9/23/21 from 10:00 PM to 9/24/21 at 7:30 AM; failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, personal care, shower, and if any housekeeping duties were completed. A review of the visit note dated 9/24/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, shampoo, skin care, addressing, personal care, shower, meal, bed linen change, dust, sweep, vacuum, and trash duties were completed. A review of the visit note dated 9/24/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, personal care, shower, meal, and if any light housekeeping duties were completed. A review of the visit note dated 9/26/21 from 10:00 PM to 9/27/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, shower, check for pressure points, and if any housekeeping duties were completed. A review of the visit note dated 9/27/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, shampoo, shower, meal, check for pressure points, toileting/ hygiene, and if any light housekeeping duties were completed. A review of the visit note dated 9/27/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, personal care, shower, check for pressure points, toileting/ hygiene, and if any light housekeeping duties were completed. A review of the visit note dated 9/28/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, meals, check for pressure points, toileting/ hygiene, light laundry, dust, sweep, vacuum, and if trash duties were completed. A review of the visit note dated 9/28/21 from 10:00 PM to 9/29/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, meal, check for pressure points, toileting/ hygiene, and if any housekeeping duties were completed. A review of the visit note dated 9/29/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, personal care, shower, check for pressure points, and if any light housekeeping duties were completed. A review of the visit note dated 9/30/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, shampoo, skin care, and if any housekeeping duties were completed. A review of the visit note dated 9/30/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, personal care, shower, meal, and if any light housekeeping duties were completed. A review of the visit note dated 9/30/21 from 10:00 PM to 10/1/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, check for pressure points, and if any housekeeping duties were completed. A review of the visit note dated 10/4/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, shower, check for pressure points, and if any housekeeping duties were completed. A review of the visit note dated 10/4/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, and if any light housekeeping duties were completed. A review of the visit note dated 10/4/21 from 10:00 PM to 10/5/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, and if any housekeeping duties were completed. A review of the visit note dated 10/5/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, personal care, shower, meals, and if any housekeeping duties were completed. A review of the visit note dated 10/5/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, and if any light housekeeping duties were completed. A review of the visit note dated 10/5/21 from 10:00 PM to 10/6/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, check for pressure points, and if any housekeeping duties were completed. A review of the visit note dated 10/6/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, and if any housekeeping duties were completed. A review of the visit note dated 10/6/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, and if any housekeeping duties were completed. A review of the visit note dated 10/6/21 from 10:00 PM to 10/7/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, and if any housekeeping duties were completed. A review of the visit note dated 10/7/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing shower, meal, and if any housekeeping duties were completed. A review of the visit note dated 10/7/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, check for pressure points, and if any housekeeping duties were completed. A review of the visit note dated 10/7/21 from 10:00 PM to 10/8/21 at 7:30 AM failed to evidence a temperature, if the patient had hair care, shampoo, dressing, skin care, dressing, shower, check for pressure points, and if any housekeeping duties were completed. A review of the visit note dated 10/12/21 from 11:00 AM to 12:00 PM failed to evidence a temperature, if the patient's hair was shampooed, skin care, shower, meal, and if any housekeeping duties were completed. A review of the visit note dated 10/12/21 from 5:00 PM to 7:00 PM failed to evidence a temperature, if the patient had hair care, shampoo, skin care, dressing, shower, light laundry, bed linen change, dust, vacuum, and if they took out the trash. A review of the visit note dated 10/12/21 from 10:00 PM to 10/13/21 at 7:30 AM failed to evidence if the patient had hair care, shampoo, skin care, dressing, shower, and if any housekeeping duties were completed. 2. The clinical record for Patient #3, was reviewed and contained a plan of care for the certification period of 8/30/21 - 10/28/21 with orders for home health aide services 9 hours/day, 5x/week x 9 weeks under Medicaid PA (prior authorization). Home Health Aide/CNA (Certified Nursing Assistant) to assist with ADL's/IADL's (activities of daily living/instrumental activities of daily living) per hha care plan." Review of the Home Health Aide care plan, effective 8/31/21, evidenced the aide should obtain a temperature, assist with a walker, and encourage fluids each visit; hair care, skin care, mouth care, foot care, nail care, dressing, light laundry, make the bed, light housekeeping, trash, personal care, shower, and sponge bath each visit per request; and shampoo, lining change, dust, sweep, and vacuum weekly per request. A review of the home health aide visit notes for certification period 8/30/21 - 10/28/21 failed to evidence that all care and services were provided as ordered as evidenced by the following: 9/24/21 from 10:30 AM - 2:30 PM and 7:30 PM - 11:30 PM, which failed to evidence a temperature, assist with a wheelchair, and encourage fluids and failed to provide 9 ordered service hours of care. The plan of care and aide care plan failed to evidence an order for services to be divided, therefore, the agency failed to provide services consecutively; 9/28/21 from 6:30 PM - 8:30 PM, which failed to evidence a temperature, assist with a wheelchair, and encourage fluids and failed to provide 9 ordered service hours of care; 10/4/21 from 1 PM - 7:30 PM, which failed to evidence a temperature or if any tasks were provided, and failed to provide 9 ordered service hours of care; 10/5, 10/6, 10/8, 10/9, and 10/11/21 from 10:30 AM - 7:30 PM which failed to evidence a temperature or if any ordered tasks were provided. No further visit notes were available to review for the certification period of 8/30/21 - 10/28/21 but the visits were indicated as complete in the electronic medical record.

Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aides provided hands on personal care as ordered per the plan of care for 1 of 7 active records reviewed. (Patient #6) Findings Include: 1. Review of an undated agency policy titled, “Home Health Aide Services” policy number C-220 indicated, “...The duties of a home health aide include the provision of hands-on personal care...Purpose: To abide by state/federal guidelines and offer guidelines to the agency staff, physician, and community for the appropriate utilization of Home Health Aide services. Special Instructions: 1. Home Health Aide services may include: a. Providing personal care services including bathing, dressing, feeding, weighing, back rubs, skin care, and shampoos as directed by the care plan and licensed professional. b. Assisting with client transfers, ambulation, and protecting the client from falls. c. Cleaning perineal area around catheter. d. Obtaining client temperature, pulse, respiration, and blood pressure. e. Maintaining a safe environment for the client…” 2. The clinical record for patient #6 was reviewed and contained a plan of care for the recertification period of 10/16/20 to 12/14/20, indicated, a home health aide 2-9 hours/day, 2-7 days a week, for 9 weeks, to provide assistance with personal care and assistance with ADLs (Activities of Daily Living). Review of the aide care plan with the effective date 8/18/21, which indicated the patient was allergic to smoke please change clothes before entering home and wash hands, diet low sodium, lived alone, needs assist for major ADLs, sob(short of breath) on exertion, confusion/forgetful, has lower and upper dentures, poor vision, up as tolerated, hair care, shampoo, mouth/denture care, foot care, dressing, make bed, lighthouse keeping bedroom, bathroom, kitchen, clean equipment, vacuum, take out trash, sweep, prepare meal, bathing personal care, shower, medication reminders, assist with ambulation cane and walker all with per patient request. A review of a home health aide note dated 8/25/21, from 2:00 PM to 5:00 PM, indicated the aide provided meal prep, light housekeeping, sweep, and take out the trash. The home health aide failed to provide any hands on personal care. A review of a home health aide note dated 9/29/21, with no time in or out recorded, indicated the aide provided light housekeeping, sweep, vacuum, and take out the trash. The home health aide failed to provide any hands on personal care. A review of a home health aide note dated 10/05/21, the note evidenced that the aide took patient #6 to the Dr (doctor) and documented, “Dr will refer her to nuro (neurologist) for nerves in her leg. She was having trouble walking today, out of breath easily and in pain from her right hip and leg.” The aide took the patient to the doctor, which was not the provision of hands on personal care in the home. A review of a home health aide note dated 10/11/21 from 3:00 PM to 5:00 PM, indicated “N/A” documented to all services except prepare meals, light housekeeping, med reminder, sweep, and take out the trash. The home health aide failed to provide any hand on personal care. A review of a home health aide note dated 10/14/21 from 3:00 PM to 5:00 PM, indicated “N/A” documented to all services. The home health aide failed to provide any hand on personal care. A review of a home health aide note dated 10/12/21 from 3:00 PM to 5:00 PM, indicated “N/A” documented to all services except prepare meals, light housekeeping, sweep and take out the trash. The home health aide failed to provide any hand on personal care. A review of a home health aide note dated 10/14/21 from 3:00 PM to 5:00 PM, indicated “N/A” documented to all services. The home health aide failed to provide any hand on personal care. During an interview on 10/22/21 at 11:00 AM, Employee O, home health aide confirmed not having a home health aide care plan to guide HHA tasks, and stated, " I just do what needs to be done." The findings were reviewed with Employee A ( the only member of the Governing Body), Administrator, Alternate Administrator, and Director of Clinical Services on 10/26/21 at 2:55 PM, in which they had no further information or documentation to provide.

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 interview, the Governing Body failed to ensure they periodically reviewed the written bylaws and assumed the full legal authority and responsibility for the operation of the home health agency by having failed to be aware of requirements of the Federal Regulations and State Rules, failed to ensure the Administrator and Alternate were appointed and adequately trained to manage and operate the home health agency, failed to ensure policies were agency-specific and in compliance with the 2018 Federal regulations; failed to enact policies and procedures to manage patients, failed to ensure that the QAPI program reflected the complexity of its organization and services for quality improvement, failed to address priorities for improved quality of care and patient safety, and failed to ensure all improvement actions were evaluated for effectiveness, failed to ensure clear expectations for patient safety were established, implemented, and maintained, and failed to ensure the agency had monitored itself to identify potential findings of fraud or waste for 1 of 1 governing body of a home health agency (See tag G942); the Administrator failed to ensure to be responsible for all of the day-to-day operations of the home health agency (See tag G948); and failed to ensure it employed a qualified a alternate clinical manager (See tag G952). The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with Condition of Participation 42 CFR 484.105 Organization and Administration of Services. *

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview, the Governing Body failed to ensure they periodically reviewed the written bylaws and assumed the full legal authority and responsibility for the operation of the home health agency by having failed to be aware of requirements of the Federal Regulations and State Rules, failed to ensure the Administrator and Alternate were appointed and adequately trained to manage and operate the home health agency, failed to ensure policies were agency-specific and in compliance with the 2018 Federal regulations; failed to enact policies and procedures to manage patients, failed to ensure that the QAPI program reflected the complexity of its organization and services for quality improvement, failed to address priorities for improved quality of care and patient safety, and failed to ensure all improvement actions were evaluated for effectiveness, failed to ensure clear expectations for patient safety were established, implemented, and maintained, and failed to ensure the agency had monitored itself to identify potential findings of fraud or waste for 1 of 1 governing body of a home health agency. Findings Include: 1. Review of an undated agency policy titled, “Governing Body” policy number B-100 indicated, “Policy: The Governing Body shall assume full legal authority and responsibility for the operation of Agency…Purpose: To ensure clients are provided with appropriate, quality services. Special Instructions: The duties and responsibilities of the Governing Body shall include: 1. Appoint a qualified Administrator. Delegate to that individual the authority and responsibility for the provision of home care services in accordance with state and federal regulation…3. Adopt and periodically review and approve the administrative and personnel policies, client care policies and procedures, bylaws as required by state licensure regulations…” 2. The Governing Body failed in oversight and amendment of agency policies as evidenced by: Review of undated policy C-500, titled "Client Discharge Process", evidenced "Discharge OASIS [Outcome and Assessment Information Set] will be conducted within 48 hours of (or knowledge of) discharge to the community or death at home." The governing body failed to ensure the policy required patients to receive a comprehensive assessment that included a summary of the patient's progress in meeting the care plan goals. Review of an undated agency policy C-500, titled "Client Discharge Process" evidenced 'Agency staff will complete complete a discharge summary that includes the following information: a. Patient status at the time of admission to the agency. b. Statement of care and interventions provided and outcomes of care. c. Status at discharge/last visit/current medications, therapies, and continuing care needs. d. Name of person or organization assuming responsibility for care. e. Instructions and referrals given to the patient/family/caregiver. f. Reason for discharge and date of discharge. 6. A copy of the discharge summary is mailed to the physician upon request." The governing body failed to ensure this policy was updated to reflect the current regulations which required the discharge summary be sent to the physician. During the entrance conference on 10/14/21, at 9:55 AM, when queried who was on the Governing Body, the owner, Employee A, confirmed being the sole Governing Body member. The owner/only member of the governing body failed to provide evidence of periodic review of the the by-laws. The Governing Body failed to implement their own policy which made the governing body responsible for the adoption and periodical review of client care policies and procedures, and review of the by-laws.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the Administrator failed to ensure to be responsible for all of the day-to-day operations of the home health agency. In regards to Patient Rights Based on record review and interview, the Administrator failed to ensure they provided information to the patients, in advance of receiving services, that included written notice of patient rights (See G412), the contact information for the administrator (See G414), and the OASIS (Outcome and Assessment Information Set) Privacy Notice (See G416); and failed to ensure patients were informed in advance of services of their right to participate in care (See G 434), receive all services (See G436); failed to ensure patients were informed of payment from federally funded programs including Medicaid (See G440), received information for the state toll-free hotline number, purpose, and hours of operation (See G444), received the agency's transfer and discharge policies (See G452); and failed to investigate all complaints (See G478), and document all complaint resolutions (See G484). These deficient practices impacted 4 of 4 active patients whose full clinical record was reviewed (1, 3, 4, 6.) In regards to Comprehensive Assessments Based on record review and interview, the Administrator failed to ensure the comprehensive assessments were completed in-person to achieve accurate and complete information and were accurately and completely filled out; accurately reflected the patient's past medical history and current health, psychosocial, functional, and cognitive status, accurately included the patient's medical, nursing, rehabilitative, social, and discharge planning needs; accurately included the patient's strengths, goals, and care preferences; accurately reflected the patient's needs, included an appropriate review/reconciliation of all prescription and over the counter medications; and failed to ensure comprehensive assessments were completed within the last 5 days of the certification period, within 48 hours of return home from hospital admission, and at discharge in 8 of 9 patient sampled records reviewed (Patients 1, 2, 3, 4, 6, 7, 8, 9). These deficient practices have the potential to affect all patients who are currently receiving home health services from this provider. In regards to Careplanning coordination, quality of care Based on record review and interview, the Administrator failed to ensure patients were accepted for services on the reasonable expectation the provider could meet their needs, failed to ensure the individualized plans of care specified the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment; (See G570); failed to ensure the plan of care was established with the physician/ or consulted to approve additions or modifications to the original plan of care, failed to ensure the plan of care was accurate, contained patient-specific and individualized interventions, measurable outcomes, and goals (See G572); failed to ensure the plan of care was individualized and included all pertinent diagnoses with their date of onset, all supplies, and equipment in the home to meet the patients' needs, specific frequency and duration of visits, nutritional requirements, accurate medications and treatments, all safety measures, infection control precautions, risk for emergency department visits and hospital readmission, services being provided by outside agencies/ facilities, all necessary interventions, specific education and training to be provided, measurable outcomes and goals identified by the home health agency and patient, and a provision orders could be received/ accepted by outside physicians (See G574); failed to ensure all services, treatments, and medications were ordered by the physician that established the plan of care prior to providing services (See G580); failed to ensure all orders were accurate and did not indicate Verbal Order (V/O) when the order was written by the agency and sent to the attending physician for signature, failed to ensure orders were complete with home health aide duties, date the clinician had obtained the order, and physician signature and date (See G584); failed to ensure clinical records included information about the services the patient received from other agencies and failed to ensure they coordinated care delivery to meet the patient’s needs (See G606); failed to ensure clinical records included information about the services the patient received from other agencies and failed to ensure they coordinated care delivery to meet the patient’s needs (See G608); failed to provide visit schedules including frequency of the visits of the home health aide according to the most updated plan of care (See G614); failed to ensure a medication list was provided to the patient (See G616); and failed to ensure all patients were provided with a copy of written instructions outlining the name and contact information of the home health clinical manager/ director of nursing (See G622) in 8 out of 9 patient records sampled (Patients’ # 1, 2, 3, 4, 6, 7, 8, 9). These deficient practices have the potential to affect all patients receiving home health services from this provider. In regards to QAPI Based on record review and interview, the Administrator failed to use measurable indicators to improve outcomes, patient safety, and quality of care (G 642;) failed to use data derived from OASIS (Outcome and Assessment Information Set) assessments to monitor services and quality of care and failed to obtain governing body approval for the frequency and detail of data collection (G 644;) failed to ensure the QAPI (Quality Assessment and Performance Improvement) program focused on high-risk, high-volume, or problem-prone areas (G 648;) failed to document the agency had considered the incidence, prevalence, and severity of problems to select indicators and performance improvement efforts (G 650;) failed to ensure performance improvement activities documented correction of identified problems related to the health and safety of patients (G 652;) failed to ensure the agency tracked and analyzed adverse patient events and implemented actions to prevent adverse events. (G 654;) failed to measure and track performance improvement projects to determine if improvement occurred and was sustained. (G 656;) failed to ensure the QAPI (Quality Assurance Performance Improvement) Program included at least 1 performance improvement project, either in development or ongoing, that was based on the agency's QAPI program activities and data obtained through tracking, measuring, and analyzing high-risk, high-volume, problem-prone areas (G 658;) and failed to document governing body oversight of an ongoing program for quality improvement to include a requirement to identify and address possible fraud or waste (G 660.) In regards to Home Health Aides Based on record review and interview, the Administrator failed to ensure all home health aides had successfully completed a satisfactory training and evaluation program or a satisfactory competency evaluation program, and all aides were found to be in good standing in the state nurse aide registry (See tag G754); failed to ensure home health aide training included classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing supervised services, totaling at least 75 hours (See tag G760); failed to ensure all aides demonstrated a minimum of 16 hours of classroom training and 16 hours of supervised practical training as part of the 75 hours (See tag G762); failed to ensure documentation that demonstrated the requirements were met (See tag G766); and failed to ensure the home health aide was evaluated based on observation of performance with a patient or pseudo-patient, written examination, oral examination, or after observation of a home health aide with a patient or with a pseudopatient as part of a simulation (See tag G768) for 3 of 4 patients reviewed for home health aide services (patients #1, 3, 6) In regards to Clinical Records Based on record review and interview, the Administrator failed to ensure physician orders were correctly identified as faxed rather than verbal orders and failed to ensure clinicians documented the date and time with each entry authentication (See G 1024.) 410 IAC 17-12-1(c)(1)

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure it employed a qualified a alternate clinical manager for 1 of 1 alternate clinical manager of the home health agency. Findings include: 1. Review of undated agency policy C-125, titled "Position: Clinical Supervisor," indicated the clinical supervisor reported to the Client Services Director. Qualifications included a minimum of 2 years nursing experience in acute care or equivalent experience with 1 year's supervisory experience, knowledge of home care state and federal regulations; knowledge of reimbursement sources and documentation requirements. On 10/14/2021, at 12:40 PM, employee A (the owner and only member of the governing body) indicated the Clinical Supervisor position was equivalent to the position of Nursing Supervisor. The owner indicated the agency was Medicaid certified. 2. Review of undated agency policy A-130, titled "Director of Clinical Services Backup," evidenced, "... in the event that the Director of Clinical Services is not available a designated qualified alternate will assume his or her duties and responsibilities and be available to respond to emergencies. In the event that the Director of Clinical Services leaves employment the designated alternate will assume the director's responsibilities until a replacement is hired and oriented." 3. Review of a document titled "Agency Staff Change Notification Form, Division of Acute Care Home Health," evidenced the agency notified the Indiana Department of Health employee C was the alternate clinical supervisor effective 9/22/21. 4. On 10/14/2021, at 12:40 PM, Employee A (owner and the only governing body member,) employee B (administrator), and employee C (alternate director of nursing) were present for the survey entrance conference. When queried as to employee D (clinical supervisor and alternate administrator) not being present, employee A and employee B indicated employee D (clinical supervisor) was out ill but had been called into the agency due to the arrival of the surveyors. When queried as to who was providing clinical oversight in the absence of the director of nursing, employee A stated employee C, alternate clinical manager, was the alternate director of nursing and was available in place of employee D. Employee C stated only being with the agency for approximately 3 weeks and denied previous home health agency experience. Employee C stated all nursing experience prior to this home health agency had been obtained as an emergency room nurse. During the interview, employee C was queried concerning clinical oversight including, but not limited to, agency census, payor requirements, service requirements, comprehensive assessments, initial assessments, supervisory visits, and plans of care. Employee C, the alternate clinical supervisor, failed to have knowledge or answer questions correctly concerning the above topics. Employee C stated, "I've only been here about 3 weeks, and I haven't received any training." When asked about the Conditions of Participation (federal regulations,) employee C stated having found a copy in the office and indicated reading parts of the regulations to try to learn. 5. Review of the personnel record for employee C (alternate clinical supervisor) date of hire 9/8/21, as a case manager, promoted to alternate clinical supervisor on 10/25/2021, evidenced a resume which indicated employee C was an emergency room (ER) supervisor from 1/29/19 to present. The record failed to evidence Employee C met the agency policy requirement for at least 1 year's supervisory experience, knowledge of home care state and federal regulations; knowledge of reimbursement sources and documentation requirements; and Medicare/Medicaid regulations for home health agencies. 6. Review of a governing body entry dated 10/25/21, provided by employee A (the owner and only member of the governing body,) evidenced employee D (clinical supervisor and alternate administrator) resigned effective 10/24/21. This entry further indicated employee C had been promoted to the role of interim clinical supervisor effective 10/25/21, and employee C was the agency alternate administrator effective 10/25/21. On 10/25/21 at 9:09 AM, employee A (owner and governing body member) and employee B (administrator) were interviewed as to why employee D (clinical supervisor and alternate administrator) denied the reason for having been absent from the survey several days was due to being at home for a family matter, and why employee D had indicated to the surveyor a last day of employment of 10/14/21. Employee A stated the resignation date was 10/25/21. Employee A provided a resignation letter from employee D that evidenced a last day of 10/25/21. When employee A (owner) was queried why employee D had indicated to surveyor (with written copy of resignation letter submitted) a resignation date of 10/14/21, rather than 10/25/21, employee A had no further comment. 7. Review of an undated document, titled "Agency Staff Change Notification Form, Division of Acute Care Home Health," evidenced agency notification to the Indiana Department of Health of employee D's (clinical supervisor) last day with the agency was 10/24/21. 8. On 10/26/21 at 11:58 AM, employee C was interviewed concerning the role of clinical supervisor. Employee C stated employee A (the owner and only governing body member) called yesterday (10/25/2021) and offered the interim clinical supervisor position. Employee C stated having declined the position of clinical supervisor, because did not feel qualified for the position, and was concerned about agency operations and patient care not being provided in compliance with regulations. Employee C indicated being fearful of retaliation. 9. Review of email provided by employee C (the alternate clinical supervisor,) on 11/19/2021, contained an attachment of a resume that was provided to the employee A (owner) by email dated 9/28/2021, which revealed employee C, the alternate clinical supervisor, did not have supervisory experience. Further review evidenced the resume did not match what was submitted to IDOH to place employee C into the position of alternate clinical supervisor. 10. On 10/26/21 at 12:31 PM, employee A (agency owner) was queried as to whether employee D would be returning to the agency, employee A (owner) stated employee D (the listed clinical supervisor) had resigned, effective 10/25/21, and provided a resignation letter for review. Review of this letter did not correspond to the effective date of resignation (10/14/21) provided by employee D to the surveyor. The owner had no explanation for why former employee D’s resignation letter last day of work had been altered. Starting 10/15/2021, the agency failed to have a qualified clinical supervisor for its 80 patients. 410 IAC 17-12-1(d)(3)

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure physician orders were correctly identified as faxed rather than verbal orders and failed to ensure clinicians documented the date and time with each entry authentication (See G 1024.) The cumulative effect of these systemic problems resulted in the agency's inability to ensure patients received appropriate care and services which could result in the agency not providing quality health care, thus being out of compliance with Condition of Participation 42 CFR 484.110, Clinical Records. Findings included: 1. Review of the clinical record for patient 1, evidenced it contained a plan of care for the certification period of 9/1/21 - 10/30/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee H, and failed to evidence the date and time of the entry. Review of a supervisory visit dated 8/31/2021, evidenced the electronic signature of employee H, the date, but no time in the authentication of the note. Review of a skilled nurse visit note dated 9/27/2021, evidenced the electronic signature of employee H, the date, but no time in the authentication of the entry. 2. Review of the clinical record for patient 2, evidenced it contained a plan of care for the certification period of 6/30/21 - 8/28/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee D, and failed to evidence the date and time of the entry. 3. Review of the clinical record for patient 3, evidenced it contained a plan of care for the certification period of 8/30/21 - 10/28/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee D, and failed to evidence the date and time of the entry. Review of a comprehensive assessment, dated 8/31/2021, evidenced electronic signature by RN, employee H, and failed to evidence the time of the entry. Review of a Hold Order, dated 9/10/2021, evidenced the order had been verbally read back by RN, employee D. Review of a Resume [sic Care] Order, dated 9/20/2021, evidenced the order had been verbally read back by RN, employee D. Review of a Recertification Order, dated 9/21/2021, evidenced the order had been verbally read back by RN, employee H. Review of a skilled nurse visit note dated 9/27/2021, failed to evidence the time of the electronic signature of the RN, employee H. 4. Review of the clinical record for patient 4, evidenced it contained a plan of care for the certification period of 8/30 /21 - 10/28/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee H, and failed to evidence the date and time of the entry. Review of a skilled nurse visit notes dated 8/26/2021, 9/9/2021, and 9/23/2021, evidenced electronic signature by RN, employee D, and each failed to evidence the time of the entry. 5. Review of the clinical record for patient 6, evidenced it contained a plan of care for the certification period of 10/17/21 - 12/15/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee C, and failed to evidence the date and time of the entry. Review of a skilled nursing visit note, dated 10/15/2021, evidenced electronic signature by RN, employee H, and failed to evidence the time of the entry. 6. Review of the clinical record for patient #7, evidenced it contained a plan of care for the certification period of 8/22/21 - 10/202/2021. The plan of care evidenced documentation of a verbal order, electronically signed by RN, employee D, and failed to evidence the date and time of the entry. Review of a skilled visit note dated 8/17/2021, evidenced electronic signature by RN, employee D, and failed to evidence the time of the entry. 7. Review of the clinical record for patient #8, evidenced it contained a plan of care for the certification period of 9/22/21 - 11/20/2021. The plan of care evidenced documentation of a verbal order, electronically signed by RN, employee C, and failed to evidence the date and time of the entry. 8. Review of the clinical record for patient #9, evidenced it contained a plan of care for the certification period of 10/16/21 - 12/14/2021. The plan of care evidenced documentation of a verbal order, electronically signed by RN, employee D, and failed to evidence the date and time of the entry. 9. On 10/22/21 at 11:06 AM, employee H (registered nurse) was interviewed concerning whether the clinician called a physician/designee to obtain orders and Employee H stated, "I've never actually called a patient's doctor before.” Employee C (alternate director of nursing) indicated the orders identified as "Verbal Orders" were not based on having obtained telephone orders from a physician but were written by the nurse and then faxed to the physician’s office for signature.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure physician orders were correctly identified as faxed rather than verbal orders and failed to ensure clinicians documented the date and time with each entry authentication for 8 of 9 clinical records reviewed (1, 2, 3, 4, 6, 7, 8, 9.) Findings include: 1. Review of the clinical record for patient 1, evidenced it contained a plan of care for the certification period of 9/1/21 - 10/30/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee H, and failed to evidence the date and time of the entry. Review of a supervisory visit dated 8/31/2021, evidenced the electronic signature of employee H, the date, but no time in the authentication of the note. Review of a skilled nurse visit note dated 9/27/2021, evidenced the electronic signature of employee H, the date, but no time in the authentication of the entry. 2. Review of the clinical record for patient 2, evidenced it contained a plan of care for the certification period of 6/30/21 - 8/28/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee D, and failed to evidence the date and time of the entry. 3. Review of the clinical record for patient 3, evidenced it contained a plan of care for the certification period of 8/30/21 - 10/28/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee D, and failed to evidence the date and time of the entry. Review of a comprehensive assessment, dated 8/31/2021, evidenced electronic signature by RN, employee H, and failed to evidence the time of the entry. Review of a Hold Order, dated 9/10/2021, evidenced the order had been verbally read back by RN, employee D. Review of a Resume [sic Care] Order, dated 9/20/2021, evidenced the order had been verbally read back by RN, employee D. Review of a Recertification Order, dated 9/21/2021, evidenced the order had been verbally read back by RN, employee H. Review of a skilled nurse visit note dated 9/27/2021, failed to evidence the time of the electronic signature of the RN, employee H. 4. Review of the clinical record for patient 4, evidenced it contained a plan of care for the certification period of 8/30 /21 - 10/28/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee H, and failed to evidence the date and time of the entry. Review of a skilled nurse visit notes dated 8/26/2021, 9/9/2021, and 9/23/2021, evidenced electronic signature by RN, employee D, and each failed to evidence the time of the entry. 5. Review of the clinical record for patient 6, evidenced it contained a plan of care for the certification period of 10/17/21 - 12/15/2021. Review of the plan of care evidenced documentation of a verbal order, electronically signed by registered nurse (RN,) employee C, and failed to evidence the date and time of the entry. Review of a skilled nursing visit note, dated 10/15/2021, evidenced electronic signature by RN, employee H, and failed to evidence the time of the entry. 6. Review of the clinical record for patient #7, evidenced it contained a plan of care for the certification period of 8/22/21 - 10/202/2021. The plan of care evidenced documentation of a verbal order, electronically signed by RN, employee D, and failed to evidence the date and time of the entry. Review of a skilled visit note dated 8/17/2021, evidenced electronic signature by RN, employee D, and failed to evidence the time of the entry. 7. Review of the clinical record for patient #8, evidenced it contained a plan of care for the certification period of 9/22/21 - 11/20/2021. The plan of care evidenced documentation of a verbal order, electronically signed by RN, employee C, and failed to evidence the date and time of the entry. 8. Review of the clinical record for patient #9, evidenced it contained a plan of care for the certification period of 10/16/21 - 12/14/2021. The plan of care evidenced documentation of a verbal order, electronically signed by RN, employee D, and failed to evidence the date and time of the entry. 9. On 10/22/21 at 11:06 AM, employee H (registered nurse) was interviewed concerning whether the clinician called a physician/designee to obtain orders and Employee H stated, "I've never actually called a patient's doctor before.” Employee C (alternate director of nursing) indicated the orders identified as "Verbal Orders" were not based on having obtained telephone orders from a physician but were written by the nurse and then faxed to the physician’s office for signature.