Every finding on record at Home Care Network Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102 Survey Dates: 06-10, 06-11, and 06-12-2024 Active Census: 13 At this Emergency Preparedness survey, Pediatric Nursing Specialist of Indiana was not found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR by Area 3 on 6-17-2024.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to maintain a communication plan that included contact information for federal, state, local, and regional entities or other sources of assistance for 77 of the 92 counties served by the agency. Findings include: 1. A Policy titled “Emergency Preparedness Policy B-400” indicated but was not limited to “ The EDP [emergency disaster plan] will identify Resource links to the local community and be maintained as the Emergency Resources List.” 2. A review of the Agency’s Emergency Disaster Preparedness (EDP) binder received from the Agency on 06-10-2024 at 10:10 AM contained a section titled “Emergency Resource List” and directions stating, “ this may be duplicated for each county in your service area.” The binder contained 15 counties serviced by the agency in the state but failed to include all 92 counties the agency serves. 3. During an interview on 06/12/2024 at 1:22 PM the Alternate Administrator reported the agency offers care in all 92 counties in Indiana but had not completed all of the emergency resources in each county because they do not have patients in the other counties currently. When queried whether the agency is licensed to provide care to patients in all counties the Alternate Administrator reported they were and would have to update the information.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey Dates: 06-10, 06-11, and 06-12-2024. 12-Month Unduplicated Skilled Admissions: 0 This deficiency report reflects State findings cited in accordance with 410 IAC 17. QR by Area 3 on 6-17-2024.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to contact and facilitate the safe transfer of their patient to the alternate entity that would be responsible for providing ongoing care for 1 of 1 transfer discharged inactive records reviewed. (Patient: #6) Findings Include: 1. A review of a revised January 2028 policy titled “Client Discharge Process” indicated but was not limited to, “ … To assure collaboration with the physician/nurse practitioner, client, family, and other … The agency must arrange a safe and appropriated transfer to other care entities when the needs of the patients … exceed the agencies capabilities … ” 2. A review of the revised October 2012 policy titled “Client Transfer” indicated but was not limited to, “ … Purpose: To assure continuity of care by providing pertinent information to another home health care agency or facility when a client is transferred … If a client is transferred to another health facility or home health agency, a copy of the summary shall be sent … ” 3. The clinical record for Patient #6 was reviewed on 06-11-2024 and indicated a start of care date of 01-19-2024. The record contained a plan of care for the recertification period of 03-19-2024 to 05-17-2024, indicating the principal diagnosis of Cerebral Palsy (a condition that affects muscle movement and coordination caused by damage to the developing brain) and other diagnoses of Microcephaly (a condition which a baby’s head circumference is significantly smaller than average), Cortical blindness (loss of visual perception due to damage to certain areas of the brain), Lack of Expected Normal Physiological Development in Childhood (developmental delayed), Disorder of urea cycle metabolism (a disorder making it hard for the body to break down proteins), Unspecified Convulsions, and Gastro-esophageal Reflux Disorder (a digestive disorder that affects the ring of muscles between your esophagus and stomach which allows stomach contents to flow up into the esophagus). Patient #6 had orders for Skilled Nursing hourly respite care for 914 hours. A review of the agency documents titled “Case Communication Notes” from 05-15-2024 to 06-10-2024, contained a communication note dated 06-11-2024, electronically signed by RN 1. The communication note indicated the caregiver for Patient #6 notified RN 1 that Patient #6 would receive services from Entity 1 due to a lack of nurse availability from Pediatric Nursing Specialist of Indiana. The communication notes failed to evidence RN 1 communication between the agency and Entity 1, the agency to which Patient #6 was discharged. During an interview on 06-11-2024 at 1:54 PM, RN 1 indicated Patient #6’s nurse retired, and the agency was unable to staff. RN 1 further stated, “ No, I do not have any communication with Entity 1. That is a coordination care barrier we need to work on.”

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 continuity of care by providing pertinent information to another home health agency or facility of their patient to the alternate entity that would be responsible for providing ongoing care for 1 of 1 transfer discharged records reviewed (Patient: #6) and 1 of 1 transfer resumed active records reviewed. (Patient: #5) Findings Include: 1. A review of the revised October 2012 policy titled “Client Transfer” indicated but was not limited to, “ … Purpose: To assure continuity of care by providing pertinent information to another home health care agency or facility when a client is transferred … If a client is transferred to another health facility or home health agency, a copy of the summary shall be sent … ” 2. The clinical record for Patient #5 was reviewed on 06-10-2024 and indicated a start of care date of 01-09-2019. The record contained a plan of care for the recertification period of 05-15-2024 to 07-13-2024, indicating the principal diagnosis of Cerebral Palsy (a condition that affects muscle movement and coordination caused by damage to the developing brain) and other diagnoses of unspecified vision loss, postsurgical malabsorption, encounter for attention to gastrostomy (a surgical opening for a tube to be inserted into the stomach from the abdominal wall for nutrition and medications), developmental disorder of speech and language, and developmental disorder of motor function. Patient #5 had orders for Skilled Nursing hourly respite care for 36.50 hours. A review of the transfer document electronically signed by Registered Nurse (RN) 1, dated 05-21-2024, indicated Patient #5 was transferred to an inpatient facility but not discharged. A review of the agency documents titled “Case Communication Notes” from 05-21-2024 to 06-10-2024, failed to provide evidence of any communication between the agency and Entity 4, the facility to which Patient #5 was transferred. During an interview on 06-11-2024 at 1:50 PM, when queried regarding facilitating care when Patient #5 was transferred to Entity 4, RN 1 confirmed they did not communicate, send the plan of care, or transfer summary to Entity 4, the facility to which Patient #5 was transferred. 3. The clinical record for Patient #6 was reviewed on 06-11-2024 and indicated a start of care date of 01-19-2024. The record contained a plan of care for the recertification period of 03-19-2024 to 05-17-2024, indicating the principal diagnosis of Cerebral palsy (a condition that affects muscle movement and coordination caused by damage to the developing brain) and other diagnoses of Microcephaly (a condition which a baby’s head circumference is significantly smaller than average), Cortical blindness (loss of visual perception due to damage to certain areas of the brain), Lack of Expected Normal Physiological Development in Childhood (developmental delayed), Disorder of urea cycle metabolism (a disorder making it hard for the body to break down proteins), Unspecified Convulsions, and Gastro-esophageal Reflux Disorder (a digestive disorder that affects the ring of muscles between your esophagus and stomach which allows stomach contents to flow up into the esophagus). Patient #6 had orders for Skilled Nursing hourly respite care for 914 hours. A review of the agency documents titled “Case Communication Notes” from 05-15-2024 to 06-10-2024 contained a communication note dated 06-11-2021, electronically signed by RN 1. The communication note indicated the caregiver for Patient #6 notified RN 1 Patient #6 would receive services from Entity 1 due to a lack of nurse availability from Pediatric Nursing Specialist of Indiana. The communication notes failed to evidence RN 1 communication between the agency and Entity 1, the agency to which Patient #6 was transferred and discharged. During an interview on 06-11-2024 at 1:54 PM, RN 1 indicated Patient #6’s nurse retired, and the agency was unable to staff. RN 1 further stated, “ No, I do not have any communication with Entity 1. That is a coordination care barrier we need to work on.” 410 IAC 17-13-2(a)(b)(9)

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 01-31-2024, 02-01-2024, 02-02-2024, 02-05-2024, 02-07-2024, 02-08-2024, 02-09-2024 and 02-12-2024. Active Census: 15 At this Emergency Preparedness survey, Pediatric Nursing Specialists of Indiana – Indianapolis was found to be out of compliance with Emergency Preparedness requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR completed by Area 3 on 2-17-2024 and 3-18-2024.

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's Emergency Preparedness program failed to evidence a testing and training plan or procedure, thereby failing to ensure the effectiveness of the agency's program, in 1 of 1 Emergency Preparedness program reviewed. Findings include: 1. Review of an agency document dated 02-08-2019, titled 'EMERGENCY PREPAREDNESS POLICY' failed to evidence a testing and training component as part of the agency's program. Review of the agency's Emergency Preparedness binder on 02-05-2024 failed to evidence a plan or procedure for testing and training the agency's Emergency Preparedness Plan. 2. On 02-05-2024 at 2:28 PM, Corporate Representative 6 indicated was a member of a local healthcare coalition and as a representative of the home health agency, had taken part in a large-scale radiation disaster drill at the local county fairgrounds in the summer of 2023 and more recently took part in that same organization's tabletop 'surge' exercise and offered these documents for review. Corporate Representative 6 indicated there were no after-action reports completed as a result of having participated in these drills/exercises, further indicated knew the after-action reports were required in order to evidence the agency's response to each drill/exercise and how the agency intended to modify their Emergency plan as a result, if need be. On 02-12-2024 at 12:24 PM, Corporate Representative 6 indicated was the only individual to take part in the drills/exercises and indicated the agency needed to include their staff, including the new Registered Nurse (RN) Case Manager, Corporate Representative 9 in such training and testing. Corporate Representative 7 indicated the agency certainly needed to revisit this.

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, after participating in Emergency drills/exercises, failed to analyze and document their response by completing after-action reports, and failed to revise the agency's Emergency Preparedness program based on the outcome, in 1 of 1 Emergency Preparedness programs reviewed. Findings include: 1. Review of an agency document dated 02-08-2019, titled 'EMERGENCY PREPAREDNESS POLICY' failed to evidence a testing and training plan or procedure as part of the agency's program. Review of the agency's Emergency Preparedness binder on 02-05-2024 failed to evidence a plan or procedure for testing and training the agency's Emergency Preparedness Plan. 2. On 02-05-2024 at 2:28 PM, Corporate Representative 6 indicated was a member of a local healthcare coalition and as a representative of the home health agency, had taken part in a large-scale radiation disaster drill at the local county fairgrounds in the summer of 2023 and more recently took part in that same organization's tabletop 'surge' exercise and offered these documents for review. When queried, Corporate Representative 6 indicated there were no after-action reports completed as a result of having participated in these drills/exercises and further indicated knew the after-action reports were required in order to evidence the agency's response to each drill/exercise and how the agency intended to modify their Emergency plan as a result of their analysis, if need be. On 02-12-2024 at 12:24 PM, when queried, Corporate Representative 7 indicated the agency's Emergency Preparedness Policy provided was the most updated version but would check to be certain there was not a more current version and indicated the agency certainly needed to revisit this. On 02-12-2024 at 12:24 PM, Corporate Representative 6 indicated she was the only individual to take part in the drills/exercises and indicated the agency needed to include their staff, including their new Registered Nurse )RN) Case Manager Corporate Representative 9 in such training and testing.

This visit was for a Federal and State Complaint survey of a Home Health provider conducted by the Indiana Department of Health. The survey was fully extended on 01-31-2024 to include all three (3) Indiana agencies: CCNs: 157428, 157197, and 157276. Survey Dates: 01-31-2024, 02-01-2024, 02-02-2024, 02-05-2024, 02-07-2024, 02-08-2024, 02-09-2024, and 02-12-2024. Complaint: 104462: Related and unrelated deficiencies cited. 12-Month Unduplicated Admissions: zero (0) QR completed by Area 3 on 2/16/2024. This survey has been modified due to further developments after the initial plan of correction was received on 3-2-24. An updated 2567 will be sent to the provider. QR compled by Area 3 on 3/18/2024.

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 identify correct durable medical equipment in the individualized plan of care in 1 of 3 home visits conducted. (Patient # 7) Findings include: 1. An agency policy number C-580IN, titled "PLAN OF CARE", with the last revised date of 06/10/2021 revealed, “ … 2. The Plan of Care shall be completed in full to include: … m. Medical supplies and equipment required n. Any safety measures to protect against injury … “ 2. A review of the clinical record of Patient #7 on 02/04/2024 evidenced a home health certification and plan of care (POC) for the certification period of 12/29/2023 to 02/26/2024 which revealed the following diagnoses but not limited to, Aicardi Syndrome (the structure that connects the two sides of the brain [called the corpus callosum] is partly or completely missing) and unspecified convulsions (sudden, violent, irregular movement of a limb or the body, caused by involuntary contraction of muscles and associated especially with brain disorders). The POC revealed the patient was to have a hospital bed, an electric air mattress, and side rails. Further review of the clinical record of Patient #7 evidenced a Recertification dated 12/27/2023 and signed by the person serving in the role of Registered Nurse, Corporate Personnel 9 indicated Patient #7 was dependent with all activities of daily living, bed mobility, and transfers, with a helper performing an activity or the assistance of 2 or more helpers and the Medical Equipment indicated the patient had a hospital bed and electric mattress. 3. On 02/05/2024, during a home visit at 10 AM to observe the person serving in the role of LPN, Corporate Personnel 13 providing skilled nursing services for Patient #7, upon entering the patient’s bedroom, this writer observed Patient #7 lying in a device that had padded sides and cradled Patient #7 which was on a king-size bed with a regular mattress. Corporate Personnel 13 completed peri care, and bath, and Patient #7 was given morning medications via MicKey G-Button (A button-type feeding tube that allows children to receive nutrition, fluids, and medicine directly into the stomach), site clean and appeared to be dry. Person E (a family member) entered the bedroom and announced they had to leave so Corporate Personnel 13 needed to hurry up and finish dressing Patient #7 so Person E could transfer Patient #7 to their wheelchair. Person E assisted with putting socks on Patient #7 while Corporate Personnel 13 was putting Patient #7 shirt on. Person E then lifted Patient #7 off the bed, placed them in their wheelchair, put the armrests down, and exited the room. 4. During an interview on 02/05/2024 at 2:46 PM, Corporate Personnel 13 indicated they had cared for Patient #7 for 8-9 years at Person E’s residence every other weekend and Monday. Corporate Personnel 13 indicated there was never a hospital bed, side rails, or air mattress in Person E’s home. Person E uses the device the patient had been lying in on the bed. Corporate Personnel 13 further indicated there was a side rail Person E had previously used but doesn't know what had happened to it. During an interview on 02/05/2024 at 1:05 PM, the person serving in the role of Administrator, Corporate Personnel 6 indicated they would have to check into the medical equipment at Person E’s residence for Patient #7. 410 IAC 17-13-1(a)(1)(D)(i-xiii)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the frequency and detail of the data collected in the development of the Qaulity Assurance Performance Improvement(QAPI) program was approved by the agency's governing body in 1 of 1 agency. Findings include: 1. A review of a policy titled "QAPI COMMITTEE" revised in January 2018, indicated under “SPECIAL INSTRUCTIONS … 3. Frequency and detail of data collection developed by QAPI committee and approved by governing body … “ 2. A review of the agency’s QAPI on 2/8/24 revealed an undated document "tracking items" listed were: monitor organizational chart to keep it up to date- administrator, monitor for governing body meetings-administrator, continue to monitor missed visits-administrator, monitor the patients for discharge-administrator, monitor for emergency preparedness documents to be sent to homes-quality, monitor for medication profiles to be sent at recertifications-quality, monitor for in-person visits-administration, monitor for complete and accurate information on the plan of care and patient-specific interventions-quality, monitor for all visits, supervisory and recertifications are completed in person. 3. A review of Governing Body Minutes dated 01/29/2024 revealed, ” … QAPI is being reviewed weekly and there are no concerns ... “ No other documents were provided to evidence other meetings which might identify governing body approval of the frequency and detail of data collection. 4. On 02/05/2024 at 2:20 PM during an interview, the person serving in the role of Administrator, Corporate Personnel 6 indicated the undated document identified as tracking items were Performance Improvement indicators that were identified at the last survey, which were discussed at the board meetings, but was unsure if they were approved by the governing body. On 02/12/2024 at 11:40 AM, the person serving in the role of Administrator, Corporate Personnel 6 indicated the Monday morning meetings were their Board Meetings. 410 IAC 17-12-2(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to establish a system to measure and track performance elements related high risk, high volume and problem prone areas to ensure improvements were sustained. Findings include: 1. A review of a policy titled "QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT" revised in January 2018, indicated, “ … 4. Data will be systematically collected to measure process and outcome. 5. Data will be assessed to: a. Identify current level of performance b. Evaluate the stability of the processes c. Identify areas to be improved D. Identify strategies to stabilize or improve processes e. Evaluate whether outcomes were achieved f. Compare results with self, other standards, and best practices, using statistical techniques … “ 2. A review of the agency’s Quality Assessment Performance Improvement (QAPI) failed to evidence a system to measure and track performance related to identified performance elements and to ensure improvements were sustained. 3. On 02/05/2024 at 1:24 the person serving in the role of Administrator, Corporate Personnel 6 indicated every quarter trends were identified, and actions were put in place to address identified problems. They further indicated they have a Performance Improvement form to start using, but hadn’t utilized it yet. 410 IAC 17-12-2(a)

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 initiate Performance Improvements Projects (PIPS) for identified elements, define why elements of a PIP were determined to be a priority and measure the progress for each PIP for the Quality Assessment and Performance Improvement Program (QAPI). Findings include: 1. An agency policy number B-260, titled "QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT," dated Jan 2005 with the last revision date of Jan 2018 revealed, “ … OBJECTIVES OF THE PROGRAM … to identify deviations from agency and professional standards and pursue improvement opportunities by assessment, planning and evaluation. To identify, address, track and resolve problems in client care services … To meet state and federal regulatory requirements. To support the organization’s process improvement through data collection and outcome measurement … To reduce factors that contribute to unanticipated outcomes … SPECIAL INSTRUCTIONS 1. … Additional actives for performance improvement will be prioritized by the agency’s governing body … 2. Data will be collected … 4. … to measure process and outcome. 5. Data will be assessed to: a. Identify current level of performance b. Evaluate the stability of the process c. Identify areas to be improved d. Identify strategies to stabilize or improve processes e. Evaluate whether outcomes were achieved … “ 2. A review of the agency’s Quality Assessment and Performance Improvement for 2023 revealed an undated handwritten document of PIPS which included but not limited to the following, “ … Continue to monitor missed visits- Admin, Monitor for pt that need discharged- Admin, Monitor for EDP’s to be sent to homes- Quality, monitor for med profiles to be sent at recertifications-Quality, Monitor for In-person visits-Admin … “ 3. On 02/05/2024 at 1:26 PM the person serving in the role of Administrator, Corporate Personnel 6 indicated they identified the undated handwritten list of PIPS since the past survey but hadn't documented why they were conducting the PIPS and the plan of action they need to put in place.

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 record review and interview, the agency failed to have a Governing Body assume full legal authority and responsibility for the agency's overall management and operation, including its quality assessment and performance improvement program. Findings include: 1. A review of a policy titled "Governing Body" last reviewed in January 2018, indicated the duties and responsibilities of the Governing Body were not limited to Appointing a qualified Administrator under state and federal regulations, and agency mission; ensuring an ongoing Quality Assessment and Performance Improvement (QAPI) program for quality improvement and patient safety is defined, implemented, and maintained; reviewing policy and procedures; adopt and periodically review and approve the administrative and personnel policies and procedures. 2. A review of the agency's policy titled "Quality Assessment Performance Improvement" revised in January 2018, stated "Special Instructions: 1. The governing body appoints a committee that must include clinical administrator, representative of all disciplines/ services provided ... 3. Frequency and detail of data collection developed by QAPI committee and approved by governing body ... 13. The QAPI Committee meeting minutes will be maintained in writing and signed by the Administrator ... " 3. A review of the Governing Body Minutes dated 1/29/2024 indicated the Administrator (Corporate Trainer), LPN 3 (presumed Alternate Administrator), and Clinical Manager (Corporate Clinical Administrator) were on the Governing Body, as well as Corporate Representatives 1, 2, 14, 15, 16, 17, and 18. The state agency failed to be notified of board member changes. 4. A review of the Governing Body meeting minutes dated 03/10/2023, 11/20/2023, 11/30/23, 12/04/23, and 12/11/23, failed to evidence that the Governing Body ensured the Quality Assessment and Performance Improvement (QAPI) addressed the program and the agency's complexity of its organization and services it provides, including services provided under contract or arrangement, indicators related to improved outcomes, emergency care services, hospital admissions and readmissions, and any action that addresses the home health agency's performance. A review of the meeting minutes dated 1/29/24 indicated the "QAPI is being reviewed weekly and there are no concerns." During an interview on 02/05/24 at 1:10 PM, when asked if the frequency and detail of data collection were approved by the agency's Governing Body, LPN 3 indicated she was unsure if the Governing Body approved it. When asked how the Governing Body was involved, the Clinical Supervisor indicated there were weekly Monday meetings where the "checklist" was reported and there was collaboration. No documentation of these weekly meetings was provided by the date of exit. During an interview with the Administrator, LPN 3, and Clinical Manager on 2/8/24 at 11:40 AM, when asked to explain the QAPI program, how it operated from auditing to Performance Improvement Plans (PIPs), who is responsible, and who is on the committee, they indicated the administrators or designee completes chart and human resource audits. If a trend is found in a particular office, it gets documented, creates a correction plan, and submits this to the Governing Body. When asked how often they have QAPI, they indicated there is a grid, and is done monthly, and then quarterly it would be discussed with all of the Administrators and Governing Body together. If a problem comes up in an agency, it would be brought up on a Monday meeting, regularly quarterly, then as needed. They indicated the committee consists of all Administrators, including the Ohio Administrators. No other documents were provided to evidence meetings were held monthly by the date of exit. During an interview on 2/12/24 at 9:38 AM, when asked to verify who was the QAPI and Governing Body Members, the Clinical Manager indicated LPN 3 was the only person who resided in Indiana and remaining "members" were from Ohio. A review of the "Quality Program Administrator" job description, updated on 10/16/2023, the qualifications included but were not limited to graduating from an accredited nursing program with a current license as a Registered Nurse in the state(s) of practice. This document was signed by the Alternate Administrator on 10/16/23. A review of LPN 3's personnel file failed to evidence any documentation she held a Registered Nurse license. 410 IAC: 17-12-1(b) 410 IAC 17-12-2(a)

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to have a qualified Administrator and an agency-appointed Governing Body to ensure a qualified Alternate Administrator and/or Clinical Manager was appointed to assume the same responsibilities and obligations as the Administrator during their absence from this agency. Findings include: Upon entering the agency on 1/31/23 at 9:15 AM, the door was locked and a note on the window indicated to knock. Upon entering, it was noted only LPN 3 was working in the office. During the entrance conference on 1/31/24 starting at 9:30 AM, the Administrator indicated a message was left with the Alternate Clinical Supervisor (Corporate Trainer), and the Clinical Manager (Corporate Clinical Administrator) was on a visit and would be in around noon. The Administrator indicated both the Clinical Manager/ Alternate Administrator and Alternate Clinical Supervisor were located in Ohio. A review of the State Agency notes in the National Database revealed that the Alternate Administrator/ Clinical Manager assumed their role on October 12, 2023. A review of the personnel file evidenced a job description titled Alternate program Administrator dated 10/16/23. A review of the Governing Body minutes dated March 10, 2023, November 20, 2023, November 30, 2023, December 4, 2024, December 11, 2023, and January 8, 2024, failed to evidence an Alternate Administrator/ Clinical Manager had been appointed by an agency appointed Governing body. On 01/31/24 at 12:45 PM, the Clinical Manager indicated she comes to the office when needed, sometimes monthly to every other month, and works remotely in Ohio. The Clinical Manager indicated she would get in her car and drive to Indiana if there were an emergency. When asked who manages faxes, physician orders, and referrals, the Clinical Manager indicated LPN 3 (presumed Alternate Administrator) manages them and uploads everything into the patient record. During an interview on 2/8/24 at 11:40 AM, when asked how one gets appointed to their positions, the Alternate Administrator/ Clinical Manager indicated they have discussions during the Governing Body meetings. When asked if there were Governing Body meeting minutes around October 2023 that would include the appointment of the Alternate Administrator/ Clinical Manager, the Alternate Clinical Manager indicated she was the secretary of the Governing Body, she knows it was discussed and should have been there. No other documents were provided by the exit date of 2/12/24, that would indicate an Alternate Administrator/ Clinical Manager was appointed. 410 IAC 17-12-1(d)(1)(2)(3)(4)

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review and interview, the Clinical Manager and the Alternate Clinical Manager failed to ensure one was available upon surveyors' arrival, failed to ensure they were able to travel within a reasonable distance to the office/and or field, failed to ensure they had a set schedule of when they will be at this location on a frequent and consistent basis to be responsible for the referrals, patient and personnel assignments, coordination of care, patient needs continually assessed, and the plan of care for this agency. Findings Include: Upon arrival at this home health agency on 1/31/24 at 9:30 AM, the door was found to be locked with a note to knock on the door. LPN (Licensed Practical Nurse) 3 was observed walking downstairs to allow surveyors in. No other person was observed in the office with LPN 3. During the entrance conference on 1/31/24 starting at 9:30 AM, the Administrator indicated a message was left with the Alternate Clinical Supervisor (Corporate Trainer), and the Clinical Manager (Corporate Clinical Administrator) was on a visit and would be in around noon. The Administrator indicated both the Clinical Manager/ Alternate Administrator and Alternate Clinical Supervisor were located in Ohio. The Clinical Manager arrived at the Indy location and met with the surveyors at approximately 12 noon. A review of the State Agency notes in the National Database revealed the Alternate Clinical Manager and Clinical Manager assumed their roles effective 10/12/23. On 01/31/24 at 12:45 PM, the Clinical Manager indicated she comes to the office when needed, sometimes monthly to every other month, and works remotely in Ohio. The Clinical Manager indicated she would get in her car and drive to Indiana if there were an emergency. When asked who manages faxes, physician orders, and referrals, the Clinical Manager indicated LPN 3 (presumed Alternate Administrator) manages them and uploads everything into the patient record. A review of the Clinical Manager's personnel file revealed the Clinical Manager resided approximately 2 hours from this office per Google Maps. This provider's service area adds additional travel time as it goes as far northeast as Wayne County, as far west as Parke County, and as far southeast as Clay County, all would require an approximate 3-hour drive. Should there be an emergency at this location, the Clinical Manager would not be able to arrive within a reasonable amount of time. On 2/1/24 at 4:00 PM, the Clinical Manager indicated the Alternate Clinical Manager was only at the office when needed and had not been back since 11/15/23. On 2/02/24 at 4:00 PM, the Alternate Clinical Manager indicated she had not been back to the office since she was here for the other surveys a few months ago and indicated she could return when called to do so. A review of the Alternate Clinical Manager's personnel file revealed the Administrator resides approximately 4 hours away from this office per Google Maps. This provider's service area adds additional travel time as it goes as far southeast as Bartholomew County which is approximately a 3.5-hour drive, as far west as Parke County, which is approximately 4.45 -hour drive, and as far southwest as Clay County, which is approximately a 4.5-hour drive. Should there be an emergency at this location, the Clinical Manager would not be able to arrive within a reasonable amount of time. On 2/8/24 at 11:40 AM, the Clinical Manager, the Alternate Clinical Manager, and LPN 3 were interviewed. It was reported LPN 3 was responsible for making the patient and personnel assignments, coordinated care, and referrals. When asked who ensures a patient's needs were continually assessed, The Clinical Manager and the Alternate Clinical Manager reported LPN 3 and the RN Case Manager were responsible. The Clinical Manager and the Alternate Clinical Manager indicated the RN Case Manager creates the plan of care and LPN 3 sends it to the physician for signature. When asked how they oversee these tasks, both reported they communicate with the case managers, the "quality department", which is LPN 3, would review it and bring it to their attention, or she takes it directly to the case manager. Both indicated LPN 3 uploads the information to the patient record. A review of the job description for the Quality Administrator which LPN 3 holds indicated the employee must hold a Registered Nurse license. A review of the organizational chart revealed that Corporate Representative 6 also held the following positions: Quality Director and Quality Nurse; Intake Director, Intake Nurse, and Intake Specialist; and Recruiting Director and Recruiter for this agency.

Primary HHA is responsible for patient care CFR(s): 484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency, which holds a Medicare Provider Enrollment agreement, failed to ensure 15 patients receiving care and services were provided by clinicians who were directly employed by this agency and failed to ensure 2 of 2 service contracts under arrangement were able to provide therapy services that cover the entire state of Indiana. Findings include: 2. A review of an agency document titled 'ANCILLARY SERVICES AGREEMENT' indicated a contract was created between the agency and Entity F, a therapy company, to provide physical and occupational therapy services to home health patients. Page 2 stated, "This agreement is entered into on the 11th day of January, 2024, by and between Home Care Network/ Pediatric Nursing Specialists (herein referred as "Agency") whose principal place of business is located [the Corporate office in Ohio's address was given] (Corporate Office) ..." The contract was signed by Corporate Representative 2, Director of Operations on 01-12-2024. The contract failed to specify which of the three Indiana agencies the agreement had been made with and failed to evidence the services would be pediatric-specific. A review of an agency document titled '[Entity D, a Therapy company] Contract/ Partnership Agreement' indicated a contract was created between the corporation, Home Care Network, Inc., and Entity D, to provide physical, occupational, and speech therapy services, as well as social work services "for Indiana and Ohio". The therapy company listed an Ohio address. The corporation, Home Care Network, Inc., also listed an Ohio address. The contract was signed by Corporate Representative 2, the Director of Operations, on 01-12-2024. The contract failed to specify which of the three Indiana agencies the agreement had been made with and failed to evidence the services would be pediatric-specific. On 01-01-2024 at 9:30 AM during the entrance conference, Corporate Representative 6 indicated the agency had recently secured contracts with two therapy companies but was not yet providing therapy services to patients. On 01-31-2024 at 12:35 PM, Corporate Representative 6, indicated she had conferred with Corporate Representative 2 that the newly obtained therapy contracts were not individualized to each of the three Indiana agencies, but with Indiana as a whole. On 01-31-2024 at 12:51 PM, Corporate Representative 7, indicated that the two newly contracted Therapy companies, Entities D and F, were chosen to ensure coverage of the entire state. On 01-31-2024 at 2:51 PM, Person E With Entity D, a Physical Therapy company, indicated was based in Ohio, stated “We don’t service Indiana” and further indicated they had no therapists who were dually licensed in both Ohio and Indiana to provide therapy services. On 01-31-2024 at 3:06 PM, Person G with Entity F, a Physical Therapy company, indicated the company did not service the entire state of Indiana. Indicated further, for example, the company would be unable to staff anyone in Evansville, IN if a patient needed to be serviced the following day. On 01-31-2024 at 4:08 PM, Corporate Representative 1, the Chief Operating Officer, indicated when vetting out therapy agencies to contract with, they attempted to ensure such agencies could service pediatric patients. When queried as to who had vetted Entities D and F, Corporate Representative 1 indicated Corporate Representatives 2, 6, and 7 had done so. When informed Entity D indicated they did not service Indiana, and Entity F indicated they could not service the whole of Indiana, Corporate Representative 1 indicated having had this same kind of problem “wherever we go”, indicating further such companies were also short-staffed. 410 IAC 17-12-2(e) 1. During the entrance conference on 1/31/24 from 9:30 AM to 10:27 AM, when asked if other Registered Nurses (RN) were working in the field besides management, Corporate Representative 6 indicated there were none, other than Corporate Representative 9, who was fairly new, and the field staff was mostly Licensed Practical Nurses (LPN). When asked if Corporate Representative 10 was an employee of this agency, Corporate Representative 6 indicated she was not but was an employee of the sister agency, Entity C, which is located at this same address. A review of the employee list indicated that 2 Registered Nurses were working in the office and 15 Registered Nurses were working in the field. On 1/31/24 at 12:31 PM, the employee list was reviewed with Corporate Representative 6 and she confirmed there were other Registered Nurses in the field and she misunderstood the question. When asked if Corporate Representative 10 was an employee of this agency again, Corporate Representative 7 stated "Yes". The agency failed to have a personnel file for Corporate Representative 10. A review of the personnel file for Corporate Representative 6 contained an I-9 tax form dated 2020 that failed to identify the employer (provider). No other tax forms were noted in the file. A review of the personnel file for Corporate Representative 7 contained an I-9 tax form dated 2021 which indicated the employer business is in Centerville, Ohio. No other tax forms were noted in the file. A review of the personnel file for Corporate Representative 8 contained an I-9 tax form dated 2020 which indicated the employer's business is in Perrysburg, Ohio. No other tax forms were noted in the file. A review of the personnel file for Corporate Representative 9, an RN Case Manager, contained an I-9 tax form that failed to identify the employer. Corporate Representative 10 failed to have a personnel file for this agency. On 01/31/2024 at 2:00 PM, Corporate Representatives 6 and 7 were asked for the W-2s for this agency and were also asked if they were paid by this agency, at which Corporate Representative 7 indicated that all W-2s come from the corporation in Ohio and no W-2s come from the agency. On 2/9/24 at 12:38 PM, Corporate Representative 5 provided 2023 W-2s. A review of Corporate Representatives 9, 10, and 13 indicated the employer's name and address was that of the Home Care Network, Inc. in Dayton Ohio. Corporate Representative 5 confirmed at 1:44 PM that the Employer ID number was directly tied to the Home Care Network and not directly connected to the agency in Indiana and all Indiana W-2s are affiliated with the Home Care Network in Dayton Ohio, and not the agency in Indiana.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was written and sent to the primary care physician who is responsible for the patient's care after discharge within 5 business days of the patient's discharge for 1 of 2 discharged record reviews. (Patient #1) Findings include: 1. An agency policy number CI-500, titled "CLIENT DISCHARGE PROCESS," dated Jan 2007 with the last revision date of Jan 2018 revealed, “ … 2. A discharge OASIS assessment will be completed when appropriate. 3. A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and service to the patient after discharge from the home health agency within 5 business days of the patient’s discharge … “ 2. A review of the clinical record of Patient #1 on 02/01/2024 revealed a home health certification and plan of care for the certification period of 11/10/2023 to 01/08/2024 and a transfer to an inpatient facility form dated 01/04/2024, which indicated the patient was not discharged from the agency. 3. A review of the agency’s discharged patients from 11/05/2023 to 02/01/2023 evidenced Patient #1 was discharged on 01/08/2024. 4. During an interview on 02/05/2024 at 1:55 PM with the person serving in the role of Administrator, Corporate Personnel 6 indicated since the patient was admitted to the hospital and the length of stay surpassed the 5-day window period for the re-certification, Patient #1 was an automatic discharge, and a discharge summary was not necessary. The agency failed to provide 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 and/or health care practitioner to ensure the safe and effective transition of care within 5 days of discharge. 410 IAC17-15-1(A)(6)

This visit was for a Federal and State Complaint survey of a Home Health provider, conducted by the Indiana Department of Health. Survey Dates: 09-19-2023, 09-20-2023, 09-21-2023, 09-22-2023, 09-25-2023, 09-26-2023, and 09-27-2023. Extended to 10-02-2023 in order to receive additional information. The Survey was expanded on 09-21-2023 to include all three (3) Indiana agencies: CCN: 157428, 157197, and 157276. The Survey was fully extended on 09-25-2023, inclusive of all three (3) Indiana agencies. Complaint: IN00101424 12 Month Unduplicated Skilled Admissions: 1 During this Federal Complaint Survey, Pediatric Nursing Specialists of Indiana was found to be out of compliance with Conditions of Participation 484.55 Comprehensive Assessment, 484.60 Care Planning, Coordination of Services, and Quality of Care, and 484.105 Organization and Administration of Services. Based on the Condition-level deficiencies during the 09-27-2023 survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 09-25-2023. Therefore and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation program(s) for a period of two years beginning 09-27-2023 and continuing through 09-26-2025. QR by Area 3 on 10-06-2023.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to discharge a patient when the agency could no longer provide physician ordered services in 1 of 6 active clinical records reviewed. (Patient #10) Findings include: A review of an agency’s policy titled ‘CLIENT ADMISSION PROCESS C-140’ dated Aug 2016 revealed, “ … POLICY Services shall be provided to all persons … SPECIAL INSTRUCTIONS … d. The client’s needs can safely and adequately be met at home. This includes the ongoing availability of personnel … 15. If the agency cannot fulfill the required health care need, a referral will be made to other appropriate community resources and referral source will be notified …” The review of the clinical record of Patient #10 on 09/27/2023 revealed a home health certification and plan of care for the certification period of 07/25/2023 to 09/22/2023 signed by corporate clinical administrator on 07/21/2023. Patient #10 had diagnoses of but not limited to autistic disorder (a developmental disability caused by differences in the brain) and chronic obstructive pulmonary disease (A group of lung diseases that block airflow and make it difficult to breathe). Their orders but not limited to for Respiratory Precautions and skilled nursing 57 hours a week. The care plan failed to notify the physician the agency was not currently staffing Patient #10. The review of the clinical record of Patient #10 on 09/27/2023 revealed a home health certification and plan of care for the certification period of 09/23/2023 to 11/21/2023 signed by RN 4 on 09/21/2023 with diagnoses of but not limited to autistic disorder (a developmental disability caused by differences in the brain) and chronic obstructive pulmonary disease (A group of lung diseases that block airflow and make it difficult to breathe), orders but not limited to for Respiratory Precautions and skilled nursing 57 hours a week. The care plan failed to notify the physician the agency was not currently staffing Patient #10. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 07/20/2023, electronically signed by corporate clinical administrator which evidenced, “ … still no SN (skilled nursing) services due to no staff, recruitment efforts continue to find new SN. [Patient #8] stays with grandparents … interdisciplinary communication communicated with physician: no …” The agency failed to notify the physician after the assessment the agency was not staffing Patient #10. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/21/2023, electronically signed by RN 4 which evidenced, “ … There continues to be no SN (skilled nursing) services due to no staff, active recruitment in process for a new SN. Family member states most of the time when [Person 16] goes to work [Person 16] pays a personal caregiver to watch [Patient #10]. Occasionally [Person 16] will take [Patient #10] … grandparents … The agency failed to notify the physician after assessment the agency was not staffing Patient #10. The record review on 09/27/2023 failed to evidence skilled nursing visits 07/25/2023 to 09/27/2023 for Patient #10. On 09/28/2023 at 6:08 PM during an interview with Person 16 (Patient #10 family member) indicated the agency wasn’t staffing Patient #10 and the agency hadn’t had a conversation with Person 16 regarding assistance with finding another agency and confirmed that recertifications are done telehealth. On 10/02/2023 at 10:40 AM during an interview with Person 17, LPN from Entity 5, indicated Person 18, the ordering physician for Patient #10 was not aware the agency hadn’t provided services for several months. On 10/27/2023 at 1:45 PM, corporate staff 2 indicated there were no communication notes regarding a discussion of finding another agency for Patient #10.

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 observation, record review, and interview the agency failed to ensure comprehensive assessments were conducted in-person by registered nurse (RN) and thereby failed to ensure the comprehensive assessments were complete and based on hands-on, skilled assessments (G0518), failed to ensure the comprehensive assessment accurately reflected the patient's status (G0526), failed to include patient's current health status (G0528), and failed to ensure a thorough review of medication occurred as part of the comprehensive assessment/reassessment to ensure accuracy of the current medication regimen (G0536). 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 with the potential to impact all patients. .

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment, and instead utilized telehealth for recertification assessments and resumption of care assessments, in 6 of 6 active clinical records reviewed (Patients #4, 5, 6, 7, 8, and 10) and 1 of 2 closed records reviewed (Patient #3). Findings include: 6. The review of the clinical record of Patient #3 on 09-25-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Resumption of Care (after inpatient stay)’ dated 06-01-2023, electronically signed by the Corporate Clinical Administrator on 06-01-2023, indicated was based on information provided by LPN 3, which included but was not limited to, “... Vital Signs Readings … Comments: obtain by sn ... Height and Weight - Not assessed (no information) ... Genitourinary ... Urine: Reported ... Urine Clarity: Other: Unable to visualize in diaper ... Urine Color: Yellow/straw ... Infections: Hx, recent UTI while in hospital, takes preventative ATB ... Urinary Diapers ... Urine Output (number of wet diapers)/day: 5-8 … Respiratory/Lung Assessment Lung Sounds Clear: in all fields per SN … Nutritional Requirements … Feeding Tolerance: Good: per sn …” The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment. 7. The review of the clinical record of Patient #6 on 09-22-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08-10-2023, electronically signed by the Corporate Clinical Administrator on 08-10-2023, and indicated was based on information provided by LPN 3, which included but was not limited to, "... Vital Signs Readings Comments: Obtained and reported by SN on shift … Skin Condition Color: Pink Temperature: Warm Turgor: Elastic: Reported by SN … Respiratory/Lung Assessment Lung Sounds Clear: In all fields per SN on Shift … Cardiac / Circulatory Status … No Problems identified … Comments Findings reported by SN on Shift … Gastrointestinal System … Other: HX of constipation and bowel obstructions, [Family Member 19] states no current issues …” The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment. 8. The review of the clinical record of Patient #7 on 09-26-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09-20-2023, electronically signed by RN 4 on 09-22-2023, indicated was based on information provided by LPN 5, which included but was not limited to, “...Vital Signs Readings ... Respiration Breaths / minute: 50 rpm Regular or Irregular: [left blank] Blood pressure Right (systolic / diastolic): [left blank] ... Left(systolic / diastolic): [left blank] ... Heart rate Pulse (beats / minute): 82 bpm ... Pulse Location: [left blank] ... Regular or Irregular Pulse: [left blank] ... Genitourinary … Urine: Reported ... Urine Clarity: ... wears a diaper. Unable to visualize clarity. Urine Color: Yellow/straw… Weight Reported: 86 pounds ... Height Unable to Measure (Note in Comment Box): Telehealth … Pediatric Cardiovascular Rhythm: Regular ... Rate: Strong ... Heart Sounds: No Problems identified … Monitor: No … Assessment findings reported by SN … Pediatric Head and Neck Nuchal rigidity reported by SN … Respiratory/Lung Assessment … Lung Sounds Clear: All fields; reported by SN …” The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment. 9. The review of the clinical record of Patient #8 on 09-22-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08-30-2023, electronically signed by the Corporate Clinical Administrator on 08-30-2023, was based on information provided by Person 21, a family member, which included but was not limited to, “…Vital Signs Readings ... Respiration Breaths / minute: [left blank] ... Regular or Irregular: [left blank] ... Blood pressure Right (systolic / diastolic): [left blank] Left (systolic / diastolic): [left blank] ... Heart rate Pulse (beats / minute): 105 bpm Pulse Location: Other(finger monitor) Regular or Irregular Pulse: Regular ... Temperature: 97.4 F Location: Temporal Artery ... Comments: reported by [Family Member 21] ... Vital Signs comments/problems [Family Member 21] stated there have been no abnormal vital signs … Weight Unable to Measure (Note in Comment Box): Unable to weigh at home and no recent DR. visits … Pain Assessment … Comments: No reported signs of pain … Skin Condition Color: Pink, reported by [Family Member 21] … Respiratory … Pulse Oximetry Level ... Yes: 96 ... Conditions at time of reading … Room Air … Respiratory/Lung Assessment … Lung Sounds Clear: Unable to obtain due to virtual visit, non labored breathing visualized on video call … Cardiac / Circulatory Status Circulatory … No Problems identified Comments Reported by [Family Member 21] … Genitourinary Urine: Reported Urine Clarity: Unable to visualize in diaper … Urine Color: Yellow/straw … Comments No odor or discoloration reported by [Family Member 21] …” The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse that included skilled hands-on physical assessment. 10. On 09-22-2023 at 10:10 AM LPN (Licensed Practical Nurse) 3, providing care for Patient #6, was queried as to how the case managing RN performs the patient’s recertification visits. Indicated the RN was the Corporate Clinical Administrator and has not come to the home but performs the recertification over the phone, utilizing the patient’s mother’s cell phone. When queried as to what the LPN is asked to provide during these calls, indicated, “vitals, how [Patient 6] is doing, any concerns” When queried about what physical assessment findings are reported, LPN 3 indicated lung sounds, bowel sounds, “all the assessment”. On 09-25-2023 at 1:43 PM, in a telephone interview with Person 20, a family member of Patient #3, indicated the agency’s home office was 'not local', reassessments of the patient were done over the phone and only one time in person by the Corporate Clinical Administrator. Indicated further the last visit, no one came to make a visit after the patient returned from the hospital but a phone call had been made instead. On 09-27-2023 at 1:13 PM, LPN 5 indicated recertification visits for Patient #7 occurred with the Case Manager (the Corporate Clinical Administrator), and a ‘Zoom’ call using audio only is usually done. LPN 5 indicated the Corporate Clinical Administrator will call on the LPN’s phone and asks about vital signs, medication changes, how feedings are going, what the ventilator settings are. On 09-27-2023 at 2:58 PM, LPN 6 indicated did not know who the case manager was for Patient #8. Indicated whoever it is does not go to the family member’s home where the patient receives services. Indicates has not been part of recertification visits but believes another family member, Person 21, does take part in these recertification visits over the phone. 1. A review of an agency’s policy titled ‘CLIENT REASSESSMENT/UPDATE OF COMPREHENSIVE ASSESSMENT C-155’ dated 08/2016 revealed, “The comprehensive assessment will be updated and revised as often as the clients’ condition warrants … PURPOSE To identify decline or improvement in health status, modify the plan of care and document changes …SPECIAL INSTRUCTION 1. Clients are reassessed to determine their response to care 2. Clients are reassessed when significant changes occur in their condition … 3. Each professional discipline will be responsible for reassessing care/services at least every 56-60 days … 6. The assessment will identify the problems, needs, strengths of the client and the care the family can provide … The initial and ongoing assessments include: a. Specific individualized client needs … 7. Client needs … will be considered in the care planning … 8. Interim assessments on skilled patients will be completed using an assessment tool that includes OASIS data elements and other information … 11. Formal reassessments are to be performed by a Registered Nurse …” 2. The review of the clinical record of Patient #4 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08/14/2023, electronically signed by corporate clinical administrator which evidenced the recertification assessment was conducted via telehealth with a family member reporting to the corporate clinical administrator the following: but not limited to, “ … Genitourinary No problems identified Urine: Reported Urine Clarity: Clear Urine Color: Yellow/straw Comments Reported by [family member] … Weight Reported: 100 lbs ([pounds] Height Unable to measure … : telehealth Nose and sinus No Problems Pediatric Cardiovascular Heart Sounds: No problems identified … Comments/Problems Reported by [family member] Pediatric Ears No problems Identified Pediatric Eyes No Problems identified Pediatric Gastrointestinal … Agnomen: Soft … /Problems/Bowel Program Reported by [family member] … Throat No problem Pediatric Musculoskeletal Poor coordination Muscle Tone Good … Pediatric Neurological Hand Grip Equal Comments/Problems Reported by [family member] … Respiratory Other: Hx [history] of Asthma Respiratory/Lung Assessment Lung sounds Clear: Unable to obtain due to virtual visit, non-labored breathing visualized on video call. Pulse Oximetry (measures oxygen in the blood) level UK-unknown … Skin Assessment Color Pink Temperature/Moisture Warm … Vital signs readings Respiration Breaths/minute [left blank] Regular or Irregular [left blank] Blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … Comments: Obtained by [family member]… “. The review of the clinical record of Patient #4 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08/14/2023, electronically signed by corporate clinical administrator which evidenced the recertification assessment was conducted via telehealth with a family member reporting to the corporate clinical administrator the following but not limited to, “ … Genitourinary No problems identified Urine: Reported Urine Clarity: Clear Urine Color: Yellow/straw Comments Reported by [family member] … Weight Reported: 100 lbs (pounds) Height Unable to measure … : telehealth Nose and sinus No Problems Pediatric Cardiovascular Heart Sounds: No problems identified … Comments/Problems Reported by [family member] Pediatric Ears No problems Identified Pediatric Eyes No Problems identified Pediatric Gastrointestinal … Agnomen: Soft … /Problems/Bowel Program Reported by [family member] … Pediatric Mouth No problems identified Comments/Problems ... Throat No problem Pediatric Musculoskeletal Poor coordination Muscle Tone Good … Pediatric Neurological Hand Grip Equal Comments/Problems Reported by [family member] … Respiratory Other: Hx(history) of Asthma Respiratory/Lung Assessment Lung sounds Clear: Unable to obtain due to virtual visit, non-labored breathing visualized on video call. Pulse Oximetry (measures oxygen in the blood) Comments: Obtained by [family member] … “. The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment. 3. The review of the clinical record of Patient #5 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/06/2023, electronically signed by corporate clinical administrator on 09-06-2023 which evidenced but not limited to, “ … height unable to measure … : telehealth pediatric cardiovascular … findings obtained and reported by SN (skilled nurse) Pediatric Head and Neck No problems identified Reported by SN Respiratory Tracheostomy Lung sounds clear in all fields per SN vital signs readings … obtained and reported by SN … interventions … assess patient vital signs every shift and PRN (as needed) … notify if temp [blank] … “. The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment. 4. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 07/20/2023, electronically signed by corporate clinical administrator which evidenced, “ … still no SN (skilled nursing) services due to no staff, recruitment efforts continue to find new SN. [Patient #8] stays with grandparents … vital signs respiration breaths/minute [blank], regular or irregular: [blank] … ". The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment, blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … temperature [blank] … vital signs comments/problems no reported issues per mom … respiratory pulse oximetry level [measures oxygen levels in the blood] UK-unknown … lung sounds clear: unable to obtain due to virtual visit, non-labored respiration noted … cardiac / circulatory status … no concerns or changes per mother … genitourinary … mom reports no odor or discoloration … interdisciplinary communication communicated with physician: no … problems, interventions, and goals, absence of signs of respiratory distress … intervention assess …”. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/21/2023, electronically signed by RN 4 which evidenced, “ … There continues to be no SN (skilled nursing) services due to no staff, active recruitment in process for a new SN … vital signs respiration breaths/minute [blank], regular or irregular: [blank] … blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … temperature [blank] … Comments: Assessment done Telehealth. Unable to obtain vitals … respiratory pulse oximetry level [measures oxygen levels in the blood] UK-unknown … lung sounds clear: Assessment done Telehealth. Unable to auscultate lung sounds ... [Person 16] states that [Patient #10] has no shortness of breath or cough … cardiac / circulatory status … no problems identified … [Person 16] states no changes or concerns … genitourinary … mom states no odor … communicated with physician: no … problems, interventions, and goals, absence of signs of respiratory distress … ” . The agency failed to ensure comprehensive assessments were conducted in person by a skilled registered nurse and included skilled hands-on physical assessment. 5. On 09/25/2023 at 2:30 PM during an interview with LPN 3 indicated they’re the only nurse that provide skill nursing to Patient #5, recertifications are conducted through the phone, never a video call because they’re not that “tech savvy”. LPN 3 indicated the corporate clinical administrator instructs her to listen to Patient #5 lungs and bowel sounds, check O2 sats, and take vital signs.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the content of the comprehensive accurately reflected the patient's status in 6 of 6 active clinical record reviews (Patients #4, 5, 6, 7, 8, and 10) and 1 of 2 closed record reviews (Patient #3). Findings include: 6. The review of the clinical record of Patient #3 on 09-25-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Resumption of Care (after inpatient stay)’ dated 06-01-2023, electronically signed by the Corporate Clinical Administrator on 06-01-2023, indicated was based on information provided by LPN 3, which included but was not limited to, “... Vital Signs Readings … Comments: obtain by sn ... Height and Weight - Not assessed (no information) ... Genitourinary ... Urine: Reported ... Urine Clarity: Other: Unable to visualize in diaper ... Urine Color: Yellow/straw ... Infections: Hx, recent UTI while in hospital, takes preventative ATB ... Urinary Diapers ... Urine Output (number of wet diapers)/day: 5-8 … Respiratory/Lung Assessment Lung Sounds Clear: in all fields per SN … Nutritional Requirements … Feeding Tolerance: Good: per sn …” The agency failed to ensure the recertification assessment accurately reflected the patient's status. 7. The review of the clinical record of Patient #6 on 09-22-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08-10-2023, electronically signed by the Corporate Clinical Administrator on 08-10-2023, and indicated was based on information provided by LPN 3, which included but was not limited to, "... Vital Signs Readings Comments: Obtained and reported by SN on shift … Skin Condition Color: Pink Temperature: Warm Turgor: Elastic: Reported by SN … Respiratory/Lung Assessment Lung Sounds Clear: In all fields per SN on Shift … Cardiac / Circulatory Status … No Problems identified … Comments Findings reported by SN on Shift … Gastrointestinal System … Other: HX of constipation and bowel obstructions, [Family Member 19] states no current issues …” The agency failed to ensure the recertification assessment accurately reflected the patient's status. 8. The review of the clinical record of Patient #7 on 09-26-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09-20-2023, electronically signed by RN 4 on 09-22-2023, indicated was based on information provided by LPN 5, which included but was not limited to, “...Vital Signs Readings ... Respiration Breaths / minute: 50 rpm Regular or Irregular: [left blank] Blood pressure Right (systolic / diastolic): [left blank] ... Left(systolic / diastolic): [left blank] ... Heart rate Pulse (beats / minute): 82 bpm ... Pulse Location: [left blank] ... Regular or Irregular Pulse: [left blank] ... Genitourinary … Urine: Reported ... Urine Clarity: ... wears a diaper. Unable to visualize clarity. Urine Color: Yellow/straw… Weight Reported: 86 pounds ... Height Unable to Measure (Note in Comment Box): Telehealth … Pediatric Cardiovascular Rhythm: Regular ... Rate: Strong ... Heart Sounds: No Problems identified … Monitor: No … Assessment findings reported by SN … Pediatric Head and Neck Nuchal rigidity reported by SN … Respiratory/Lung Assessment … Lung Sounds Clear: All fields; reported by SN …” The agency failed to ensure the recertification assessment accurately reflected the patient's status. 9. The review of the clinical record of Patient #8 on 09-22-2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08-30-2023, electronically signed by the Corporate Clinical Administrator on 08-30-2023, was based on information provided by Person 21, a family member, which included but was not limited to, “…Vital Signs Readings ... Respiration Breaths / minute: [left blank] ... Regular or Irregular: [left blank] ... Blood pressure Right (systolic / diastolic): [left blank] Left (systolic / diastolic): [left blank] ... Heart rate Pulse (beats / minute): 105 bpm Pulse Location: Other(finger monitor) Regular or Irregular Pulse: Regular ... Temperature: 97.4 F Location: Temporal Artery ... Comments: reported by [Family Member 21] ... Vital Signs comments/problems [Family Member 21] stated there have been no abnormal vital signs … Weight Unable to Measure (Note in Comment Box): Unable to weigh at home and no recent DR. visits … Pain Assessment … Comments: No reported signs of pain … Skin Condition Color: Pink, reported by [Family Member 21] … Respiratory … Pulse Oximetry Level ... Yes: 96 Date: 08/30/2023 ... Conditions at time of reading … Room Air … Respiratory/Lung Assessment … Lung Sounds Clear: Unable to obtain due to virtual visit, non labored breathing visualized on video call … Cardiac / Circulatory Status Circulatory … No Problems identified Comments Reported by [Family Member 21] … Genitourinary Urine: Reported Urine Clarity: Unable to visualize in diaper … Urine Color: Yellow/straw … Comments No odor or discoloration reported by [Family Member 21] …” The agency failed to ensure the recertification assessment accurately reflected the patient's status. 10. 09-21-2023 at 3:17 PM, when queried as to why there were no blood pressures ordered on the plans of care and why often found blank in assessments, Administrative Person 1 indicated often the action of taking the blood pressure reading was not well tolerated by some patients. On 09-22-2023 at 10:10 AM LPN (Licensed Practical Nurse) 3, providing care for Patient #6, was queried as to how the case managing RN performs the patient’s recertification visits. Indicated the RN was the Corporate Clinical Administrator and has not come to the home but performs the recertification over the phone, utilizing the patient’s mother’s cell phone. When queried as to what the LPN is asked to provide during these calls, indicated, “vitals, how [Patient 6] is doing, any concerns” When queried about what physical assessment findings are reported, LPN 3 indicated lung sounds, bowel sounds, “all the assessment”. On 09-25-2023 at 1:43 PM, in a telephone interview with Person 20, a family member of Patient #3, indicated the agency’s home office was 'not local', reassessments of the patient were done over the phone and only one time in-person by the Corporate Clinical Administrator. Indicated further that for the last 'visit', no one came to make an in-person visit after the patient returned home from the hospital, but a phone call had been made instead. On 09-27-2023 at 1:13 PM, LPN 5 indicated recertification visits for Patient #7 occurred with the Case Manager (the Corporate Clinical Administrator), and a ‘Zoom’ call using audio only is usually done. LPN 5 indicated the Corporate Clinical Administrator will call on the LPN’s phone and asks about vital signs, medication changes, how feedings are going, what the ventilator settings are. On 09-27-2023 at 2:58 PM, LPN 6 indicated did not know who the case manager was for Patient #8. Indicated whoever it is does not go to the family member’s home where the patient receives services. Indicates has not been part of recertification 'visits' but believes another family member, Person 21, does take part in these recertification visits over the phone. 410 IAC 17-15-1(a) 1. A review of an agency’s policy titled ‘COMPREHENSIVE CLIENT ASSESSMENT C-145’ DATED 06/2012 revealed, “POLCIY A thorough, well-organized, comprehensive and accurate assessment … The depth and frequency of ongoing assessments will depend on client needs … will be done at least every sixty (60) day period … SPECIAL INSTRUCTIONS The Comprehensive Assessment will be completed by a Registered Nurse … 3. In addition to general health status/system assessment, the agency comprehensive assessment tool … will include: … d. Respiratory status … f. Elimination status … h. integumentary status i. Neuro/emotional/behavioral status, k. Medications … 4. Nutritional status … a. weight loss … 6. Assessment and documentation are made regarding whether the home is environment is suitable … 9. Assessment will be completed by registered nurses … 10. Client populations with specialized needs, i.e., pediatric services, will be assessed by professionals with appropriate skills … 11. Client needs are assessed and care guidelines established based on the assessment data … 13. Reassessments are conducted based on clients needs, physician orders, professional judgement … or other regulatory requirements … “ A review of an agency’s policy titled ‘CLIENT REASSESSMENT/UPDATE OF COMPREHENSIVE ASSESSMENT C-155’ dated 08/2016 revealed, “The comprehensive assessment will be updated and revised as often as the clients’ condition warrants … PURPOSE To identify decline or improvement in health status, modify the plan of care and document changes …SPECIAL INSTRUCTION 1. Clients are reassessed to determine their response to care 2. Clients are reassessed when significant changes occur in their condition … 3. Each professional discipline will be responsible for reassessing care/services at least every 56-60 days … 5. Special attention will be paid to client-centered goals … 6. The assessment will identify the problems, needs, strengths of the client and the care the family can provide … The initial and ongoing assessments include: a. Specific individualized client needs … 7. Client needs … will be considered in the care planning … 8. Interim assessments on skilled patients will be completed using an assessment tool that includes OASIS data elements and other information … 11. Formal reassessments are to be performed by a Registered Nurse …” 2. The review of the clinical record of Patient #4 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08/14/2023, electronically signed by corporate clinical administrator which evidenced the recertification assessment was conducted via telehealth with a family member reporting to the corporate clinical administrator the following: but not limited to, “ … Genitourinary No problems identified Urine: Reported Urine Clarity: Clear Urine Color: Yellow/straw Comments Reported by [family member] … Weight Reported: 100 lbs ([pounds] Height Unable to measure … : telehealth Nose and sinus No Problems Pediatric Cardiovascular Heart Sounds: No problems identified … Comments/Problems Reported by [family member] Pediatric Ears No problems Identified Pediatric Eyes No Problems identified Pediatric Gastrointestinal … Agnomen: Soft … /Problems/Bowel Program Reported by [family member] … Throat No problem Pediatric Musculoskeletal Poor coordination Muscle Tone Good … Pediatric Neurological Hand Grip Equal Comments/Problems Reported by [family member] … Respiratory Other: Hx [history] of Asthma Respiratory/Lung Assessment Lung sounds Clear: Unable to obtain due to virtual visit, non-labored breathing visualized on video call. Pulse Oximetry (measures oxygen in the blood) level UK-unknown … Skin Assessment Color Pink Temperature/Moisture Warm … Vital signs readings Respiration Breaths/minute [left blank] Regular or Irregular [left blank] Blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … Comments: Obtained by [family member]… “. The agency failed to ensure the recertification assessment accurately reflected the patient's status. 3. The review of the clinical record of Patient #5 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/06/2023, electronically signed by corporate clinical administrator which evidenced but not limited to, “ … height unable to measure … : telehealth pediatric cardiovascular … findings obtained and reported by SN (skilled nurse) Pediatric Head and Neck No problems identified Reported by SN Respiratory Tracheostomy Lung sounds clear in all fields per SN vital signs readings … obtained and reported by SN … interventions … assess patient vital signs every shift and PRN (as needed) … notify if temp [blank] … “ The agency failed to ensure the recertification assessment accurately reflected the patient's status. 4. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 07/20/2023, electronically signed by corporate clinical administrator which evidenced, “ … still no SN (skilled nursing) services due to no staff, recruitment efforts continue to find new SN. [Patient #8] stays with grandparents … vital signs respiration breaths/minute [blank], regular or irregular: [blank] … blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … temperature [blank] … vital signs comments/problems no reported issues per mom … respiratory pulse oximetry level [measures oxygen levels in the blood] UK-unknown … lung sounds clear: unable to obtain due to virtual visit, non-labored respiration noted … cardiac / circulatory status … no concerns or changes per mother … genitourinary … mom reports no odor or discoloration … interdisciplinary communication communicated with physician: no … problems, interventions, and goals, absence of signs of respiratory distress … intervention assess …” The agency failed to ensure the recertification assessment accurately reflected the patient's status. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/21/2023, electronically signed by RN 4 which evidenced, “ … There continues to be no SN (skilled nursing) services due to no staff, active recruitment in process for a new SN. Family member states most of the time when [Person 16] goes to work [Person 16] pays a personal caregiver to watch [Patient #10]. Occasionally [Person 16] will take [Patient #10] … grandparents … vital signs respiration breaths/minute [blank], regular or irregular: [blank] … blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … temperature [blank] … Comments: Assessment done Telehealth. Unable to obtain vitals … respiratory pulse oximetry level [measures oxygen levels in the blood] UK-unknown … lung sounds clear: Assessment done Telehealth. Unable to auscultate lung sounds. Mom states that [Patient #10] has no shortness of breath or cough … cardiac / circulatory status … no problems identified … mom states no changes or concerns … genitourinary … mom states no odor … communicated with physician: no … problems, interventions, and goals, absence of signs of respiratory distress … intervention assess …” The agency failed to ensure the recertification assessment accurately reflected the patient's status. 5. On 09/25/2023 at 2:30 PM during a interview with LPN 3 indicated they’re the only nurse that provide skill nursing to Patient #5, recertifications are conducted through the phone, never a video call because they’re not that “tech savvy”. LPN 3 indicated the corporate clinical administrator instructs her to listen to Patient #5 lungs and bowel sounds, check O2 sats, and take vital signs.

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 an accurate and complete assessment was completed to reflect the patient's current health status in 3 of 8 records reviewed. (Patients #4, 5, and 10) Findings include: A review of an agency’s policy titled ‘COMPREHENSIVE CLIENT ASSESSMENT C-145’ DATED 06/2012 revealed, “POLICY A thorough, well-organized, comprehensive and accurate assessment … SPECIAL INSTRUCTIONS The Comprehensive Assessment will be completed by a Registered Nurse … 3. In addition to general health status/system assessment, the agency comprehensive assessment tool … will include: … d. Respiratory status … f. Elimination status … h. integumentary status i. Neuro/emotional/behavioral status, k. Medications … 4. Nutritional status … a. weight loss … 6. Assessment and documentation are made regarding whether the home is environment is suitable … ". 2. The review of the clinical record of Patient #4 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 08/14/2023, electronically signed by corporate clinical administrator which evidenced but not limited to, “ … Genitourinary No problems identified Urine: Reported Urine Clarity: Clear Urine Color: Yellow/straw Comments Reported by Grandmother … Weight Reported: 100 lbs ([pounds] Height Unable to measure … : telehealth Nose and sinus No Problems Pediatric Cardiovascular Heart Sounds: No problems identified … Comments/Problems Reported by Grandmother Pediatric Ears No problems Identified Pediatric Eyes No Problems identified Pediatric Gastrointestinal … Agnomen: Soft … /Problems/Bowel Program Reported by Grandmother … Pediatric Mouth No problems identified Comments/Problems Grandmother is going to make an appointment for Patient #4 for a Monday as she is off work and can take her in. Patient #4 required sedation for any dental work Throat No problem Pediatric Musculoskeletal Poor coordination Muscle Tone Good … Pediatric Neurological Hand Grip Equal Comments/Problems Reported by Grandmother … Respiratory Other: Hx [history] of Asthma Respiratory/Lung Assessment Lung sounds Clear: Unable to obtain due to virtual visit, non-labored breathing visualized on video call. Pulse Oximetry (measures oxygen in the blood) level UK-unknown … Skin Assessment Color Pink Temperature/Moisture Warm … Vital signs readings Respiration Breaths/minute [left blank] Regular or Irregular [left blank] Blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … Comments: Obtained by grandmother … “. The agency failed to ensure the recertification assessment was completed accurately by a registered nurse. 3. The review of the clinical record of Patient #5 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/06/2023, electronically signed by corporate clinical administrator which evidenced but not limited to, “ … height unable to measure … : telehealth pediatric cardiovascular … findings obtained and reported by SN (skilled nurse) Pediatric Head and Neck No problems identified Reported by SN Respiratory Tracheostomy Lung sounds clear in all fields per SN vital signs readings … obtained and reported by SN … interventions … assess patient vital signs every shift and PRN (as needed) … notify if temp [blank] … “. The agency failed to ensure the recertification assessment was completed accurately by a registered nurse. 4. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 07/20/2023, electronically signed by corporate clinical administrator which evidenced, “ … still no SN (skilled nursing) services due to no staff, recruitment efforts continue to find new SN. [Patient #8] stays with grandparents … vital signs respiration breaths/minute [blank], regular or irregular: [blank] … blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … temperature [blank] … vital signs comments/problems no reported issues per mom … respiratory pulse oximetry level [measures oxygen levels in the blood] UK-unknown … lung sounds clear: unable to obtain due to virtual visit, non-labored respiration noted … cardiac / circulatory status … no concerns or changes per mother … genitourinary … mom reports no odor or discoloration … interdisciplinary communication communicated with physician: no … problems, interventions, and goals, absence of signs of respiratory distress … intervention assess …” The agency failed to ensure a complete, accurate assessment was completed by a registered nurse. The review of the clinical record of Patient #10 on 09/27/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/21/2023, electronically signed by RN 4 which evidenced, “ … There continues to be no SN (skilled nursing) services due to no staff, active recruitment in process for a new SN. Family member states most of the time when [Person 16] goes to work [Person 16] pays a personal caregiver to watch [Patient #10]. Occasionally [Person 16] will take [Patient #10] … grandparents … vital signs respiration breaths/minute [blank], regular or irregular: [blank] … blood pressure right (systolic /diastolic): [blank] left (systolic / diastolic) [blank] … heart rate pulse (beats / minute) [blank] … temperature [blank] … Comments: Assessment done Telehealth. Unable to obtain vitals … respiratory pulse oximetry level [measures oxygen levels in the blood] UK-unknown … lung sounds clear: Assessment done Telehealth. Unable to auscultate lung sounds. Mom states that [Patient #10] has no shortness of breath or cough … cardiac / circulatory status … no problems identified … mom states no changes or concerns … genitourinary … mom states no odor … communicated with physician: no … problems, interventions, and goals, absence of signs of respiratory distress … intervention assess …” The agency failed to ensure a complete, accurate assessment was completed by a registered nurse. 5. On 09/25/2023 at 2:30 PM during a interview with LPN 3 indicated the corporate clinical administrator instructs her to listen to Patient #5 lungs and bowel sounds, check O2 sats, and take vital signs. On 09/20/2023 at 4:46 PM, the corporate clinical administrator indicated that RN’s (Registered Nurses) are to complete assessments and care plans, assessments should be a complete head to toe assessment.

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 a thorough review of medication occurred as part of the comprehensive assessment/reassessment to ensure accuracy of the current medication regimen for 1 of 8 clinical records reviewed (Patient #6). Findings include: Review of an agency document dated June 2012 titled, 'Comprehensive Assessment C-145' stated, "...SPECIAL INSTRUCTIONS 1. The Comprehensive Assessment will be completed by a registered nurse ... 2. The Comprehensive Assessment will include a full review of all medications the client is using. This assessment will identify potential adverse effects and drug reactions, including ineffective therapy ... and non-compliance with therapy ..." On 09-22-2023 at 10:10 AM during a home visit, LPN (Licensed Practical Nurse) 3 was observed providing care for Patient #6. When queried as to what the seizure precautions were for this patient, the LPN indicated they would help the patient to the floor if they were falling, would remove any items near the patient and clear the area for safety, when the patient had returned to baseline would put patient back into the chair and check the patient’s oxygen saturation levels. Indicated this in fact had happened recently, and LPN 3 helped the patient to the floor and stayed with them, the patient quickly recovered and the LPN assisted patient back into their chair. The LPN indicated the next day they were not on duty and when they returned the following day, the family had informed the LPN the patient had had a cluster of seizures and the parents administered Ativan to the patient. When LPN 3 was queried about when Diastat (a medication for emergency use, in gel form, given by rectum, to help stop seizure activity) would be used during a seizure, as it appeared on the agency’s current medication list for the patient, the LPN indicated that the family had stated Diastat is ‘very expensive’, and there is currently no Diastat in the home. On 09-22-2023 at 10:30 AM during a home visit for Patient #6, Person 19, a family member, indicated there was not a seizure protocol from the agency that they were aware of. Person 16 was queried as to what should happen if Patient #6 has a seizure, Person 16 presented their self-authored ‘Seizure Action, Injury Protection (and Other Emergency) Plan’ for review. The plan stated, “... When parent or sibling is at home, call out for them immediately … check oxygen saturation level … administer oxygen within guidelines if needed … track time, seizure type, duration and record on daily log … Especially in the case of cluster seizures, administer [Sic] 0.5 ml BID Lorazepam 2mg/ml (Ativan) … Alternative: Administer Diastat (Valium) per physician’s instructions (five minute seizures or cluster seizures) … NOTE: We do not keep Diastat or Versed these on hand anymore – expensive, expired quickly, and we have been successful with the Lorazepam … Parent should be notified immediately given the following conditions: After seizure [Patient 6] does not return to awareness/behavior/activity level near baseline. After any seizure that is followed by breathing difficulty. After any cluster of seizures. After any prolonged seizure with a duration of two minutes or more. After any seizure that is unusual in presentation, of unusual intensity for Megan … [Sic] CALL 911 IF IT IS AN EMERGENCY …” On 9-22-2023 at 2:05 PM, Administrative Person 1 indicated being unaware of Patient #6’s recent seizure activity. Administrative Person1 and the Corporate Clinical Administrator were also unaware of the family's own seizure protocol at home and a copy was presented for their review. While discussing and reviewing the Seizure Plan created by Person 19, Corporate Person 2 indicated the need to incorporate information regarding the seizure protocol into the patients plan of care, and medications documented on the current medication list not actively being taken should be explained and added to the RN’s 60-day summary and additionally should be part of physician’s verbal order. The Corporate Clinical Administrator indicated the agency ‘definitely needed clarification’ from the physician on the patient’s seizure protocol. 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 ensure that patient's were serviced based on the reasonable expectation the agency could meet patient's medical and nursing needs by failing to ensure each patient received an individualized plan of care, care and services specified as necessary to meet patient-specific needs as identified and based on an accurate comprehensive assessment, and failed to ensure the individualized plan of care contained safety measures to protect against injury (i.e. seizure, respiratory, and aspiration precautions) (G0574), failed to ensure services and treatment were included on the Plan of Care and only provided as ordered by a Physician (G0580), and failed to ensure communications were made with physicians involved in the plan of care (G0602). 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 for all patients. .

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 ensure patient-specific interventions were identified in the care plans of 4 of 6 active clinical records reviewed. (Patients #4, 5, 6, and 10) Findings include: Review of the clinical record for Patient #6 with a start of care of 10-04-2016 contained a Plan of Care for the certification period of 08-13-2023 to 10-11-2023 with diagnoses that included but were not limited to: arthrogryposis (a variety of non-progressive conditions that are characterized by multiple joint contractures (stiffness) and involves muscle weakness found throughout the body at birth), cerebral palsy (a group of disorders that affect a person's ability to move and maintain balance and posture), developmental delays (when a child's progression through predictable developmental phases slows, stops, or reverses, symptoms include slower-than-normal development of motor, cognitive, social, and emotional skills), seizure disorder (burst of uncontrolled electrical activity between brain cells that causes temporary abnormalities in muscle tone or movements (stiffness, twitching or limpness), behaviors, sensations or states of awareness). The document was completed and signed by the Corporate Clinical Administrator on 08-10-2023. A section titled 'Safety Measures' included 'Seizure Precautions', but the Plan of Care failed to evidence an individualized seizure protocol for the patient, and failed to evidence associated interventions and goals. On 09-22-2023 at 10:10 AM during a home visit, LPN (Licensed Practical Nurse) 3 was observed providing care for Patient #6. When queried as to what the seizure precautions are for this patient, the LPN indicated that they would help the patient to the floor if they were falling, would remove any items near the patient and clear the area, when returned to baseline would put patient back into the chair and check the patient’s oxygen saturation levels. Indicated this in fact had happened recently, and LPN 3 helped the patient to the floor and stayed with them, the patient quickly recovered and the LPN assisted patient back into their chair. The LPN indicated the next day they were not on duty and when they returned the following day, the family had informed the LPN the patient had had a cluster of seizures and that the parents administered Ativan to the patient. When LPN 3 was queried about when Diastat (a medication for emergency use, in gel form, given via the rectum to help stop seizure activity) would be used during a seizure, as it was on the agency’s current medication list for the patient, the LPN indicated that the family had stated Diastat is ‘very expensive’, and there is currently no Diastat in the home. On 09-22-2023 at 10:30 AM during a home visit for Patient #6, Person 19, a family member, indicated there was not a seizure protocol in place from the agency that they were aware of. Person 16 was queried as to what should happen if Patient #6 has a seizure, Person 16 presented their self-authored ‘Seizure Action, Injury Protection (and Other Emergency) Plan’ for review. The plan stated, “... When parent or sibling is at home, call out for them immediately … check oxygen saturation level … administer oxygen within guidelines if needed … track time, seizure type, duration and record on daily log … Especially in the case of cluster seizures, administer 0.5 ml BID Lorazepam 2mg/ml (Ativan) … Alternative: Administer Diastat (Valium) per physician’s instructions (five minute seizures or cluster seizures) … NOTE: We do not keep Diastat or Versed these on hand anymore – expensive, expired quickly, and we have been successful with the Lorazepam … Parent should be notified immediately given the following conditions: After seizure [Patient 6] does not return to awareness/behavior/activity level near baseline. After any seizure that is followed by breathing difficulty. After any cluster of seizures. After any prolonged seizure with a duration of two minutes or more. After any seizure that is unusual in presentation, of unusual intensity for Megan … CALL 911 IF IT IS AN EMERGENCY …” On 9-22-2023 at 2:05 PM, Administrative Person 1 indicated being unaware of Patient #6’s recent seizure activity or the family' s 'Seizure Plan', a copy is presented for review. While discussing and reviewing the Seizure Plan created by Person 19, Corporate Person 2 indicated the need to include information regarding the seizure protocol in the Plan of care and the medications documented on the current medication list that were not actively being taken could be explained and added to the RN’s 60-day summary narrative and additionally could be part of physician’s verbal order. The Corporate Clinical Administrator indicated the agency ‘definitely needed clarification’ from the physician on the patient’s seizure protocol. On 09-26-2023 at 2:09 PM, when queried as to what more should done or should be included when 'precautions' are ordered for patients in their plan of care, aside from listing the words 'seizure precautions', 'respiratory precautions' or 'aspiration precautions', the Corporate Clinical Administrator indicated the precautions should be in the interventions and interventions should be patient specific, indicated further they are not currently reaching out to physicians to get those individualized plans of care/orders. 1. A review of an agency’s policy titled, ‘PLAN OF CARE C-580IN’ dated 06/10/2021 revealed, “POLICY … The Plan of Care is based on a comprehensive assessment … SPECIAL ISNTRUCTIONS … 2. The Plan of Care Shall be completed in full to include: … i. Functional limitations and precautions … k. Specific dietary or nutritional requirements or restrictions l. Medications, treatments, and procedures … n. Any safety measures to protect against injury … u. … all necessary interventions to address the underlying risk factors … “. 2. A review of the clinical record of Patient #4 on 9/22/23 revealed a home health certification and plan of care for the certification period of 08/15/2023 to 10/13/2023 diagnoses include but not limited to autistic disorder, feeding difficulties, mild intermittent asthma. The patient is to receive home health aide respite services 12 to 16 hours per visit as needed. Safety measures include but not limited to elopement risk precautions. The care plan failed to identify patient specific interventions for elopement risk precautions. 3. The review of the clinical record of Patient #5 on 09/22/2023 revealed a home health certification and plan of care for the certification period of 09/09/2023 to 11/07/2023 signed by corporate clinical administrator on 09/06/203 with diagnose of but not limited to congenital malformation of skull and face bones (the result of an infant's skull or facial bones fusing together too soon or in an abnormal way, the brain can become damaged as it grows and cannot expand properly, and the infant may develop neurological problems) and tracheostomy (is a surgical airway management procedure which consists of making an incision on the front of the neck and opening a direct airway through an incision in the trachea). Safety Measures include but not limited to trach and respiratory, and aspiration precautions. Problems and interventions include but not limited to, “… nursing to assess every shift and prn (as needed) … respiratory … monitor trach stoma site for drainage or breakdown q (every) shift and prn … “. The agency failed to ensure specific interventions were in place and patient specific for tracheostomy, respiratory, and aspiration precautions. 4. The review of the clinical record of Patient #10 on 09/27/2023 revealed a home health certification and plan of care for the certification period of 09/23/2023 to 11/21/2023 signed by RN 4 on 09/21/2023 with diagnoses of but not limited to autistic disorder (a developmental disability caused by differences in the brain) and chronic obstructive pulmonary disease (A group of lung diseases that block airflow and make it difficult to breathe), orders but not limited to for Respiratory Precautions. Problems and Interventions listed but not limited to: Nursing to assess patient vital signs every shift and as needed with changes, notify if temperature (left blank), Nursing to assess every shift and prn with changes cardiovascular, respiratory, neurological, skin integumentary, digestive gastrointestinal, and genitourinary status every shift. The care plan failed to identify patient specific respiratory precautions. 5. On 09/27/2023 at 1:18 PM, Corporate Staff 2 indicated there needs to be more for seizure precautions. On 09/27/2023 at 1:29 during an interview with the administrator indicated with interventions for respiratory there should be oxygen saturation (measurement of oxygen in the blood) and checking with the physician what would be a respiratory emergency and what should be done. On 09/27/2023 at 1:47 PM, corporate clinical administrator indicated there should be patient specific interventions by adding O2 sats (measure oxygen in the blood) and making aspiration and trach precautions more specific for Patients. On 09/27/2023 at 1:25 the administrator indicated all patient specific interventions need to be in place for specific precautions.

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 services and treatment were included on the Plan of Care and only provided as ordered by a Physician, in 1 of 6 active clinical records reviewed (Patient #7). Findings include: Review of an agency document dated 06-10-2021 titled, 'PLAN OF CARE - C-580IN' stated, "POLICY 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 ... and health team members ... SPECIAL INSTRUCTIONS The Plan of Care shall be completed in full to include: ... l. ... treatments, and procedures ... p. Treatment goals ..." Review of the clinical record of Patient #7 on 09-26-2023 revealed a document titled, 'HOME HEALTH CERTIFICATION AND PLAN OF CARE' was dated 07-18-2023 and signed by the Corporate Clinical Administrator, contained diagnoses which included but were not limited to: Marfan's syndrome (a genetic disorder that changes the proteins that help make healthy connective tissue. This leads to problems with the development of connective tissue, which supports the bones, muscles, organs, and tissues in the body) and cerebral palsy (neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development, primarily affects body movement and muscle coordination). Medications included, but were not limited to, "Bisacodyl EC (a stool softener) Oral Tablet Delayed Release 5 MG / 1 tablet / G-tube / PRN Twice a Day Bowel maintenance "... MiraLax (a laxative that provides effective, gentle relief from occasional constipation) Oral Powder 17 GM/SCOOP / 1 scoop / G-tube / PRN Once a Day Add to 4 oz H2O Bowel maintenance ... Senna (a laxative used to relieve occasional constipation) Oral Liquid 8.8 MG/5ML / 5 ml / G-tube / PRN Twice a Day Bowel maintenance ..." The Plan of Care narrative stated, "... Abdomen soft and non-distended with positive bowel sounds x 4 quads at this time, [LPN 5] completed manual stimulation/removal to assist with BM's ..." The plan of care failed to evidence a bowel regimen for the patient and failed to evidence orders for digital disimpaction (procedure to remove trapped stool from the rectum. A provider uses a gloved finger to break up the stool and remove it, giving quick relief from fecal impaction and severe constipation, if done incorrectly, can cause complications like: arrhythmia (irregular heartbeat), damage to the walls of your anus, rectum, or large intestine, or fainting). On 09-27-2023 at 1:13 PM, when queried regarding the entry found on the Plan of Care regarding manual stimulation/removal of stool foor Patient #7, LPN 5 indicated having completed this procedure for the patient when needed, when queried as to whether there were orders for a bowel regimen or for digital disimpaction LPN 5 stated, “we don’t technically have a specific order for digital disimpaction” indicating it was not ordered, then asked, “do we need an order for that?” On 09-27-2023 at 2:42 PM, after further investigation, Administrative Person 1 indicated there were no orders for a bowel regimen, or for the LPN to perform digital disimpaction for Patient #7 and indicated the LPN needed to have physician orders to perform this. 410 IAC 17-13-1(a)

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure the ordering physicians for patients were notified of recertification and resumption of care assessments being performed via telehealth with staff or a family member in 4 of 6 active clinical records review. (Patients #5, 6, 7, 8, and 10) Findings include: On 09-27-2023 at 10:39 AM received return call from Person 23 with Doctor 22’s office, primary care for Patient #3, indicated no calls/communication on record from the agency. Indicated further that Doctor 22 graduated and has not seen patients since 06-20-2023, indicates Doctor 24 has taken over for them. On 09-28-2023 at 2:09 PM, in a return phone call, when queried regarding communications received from the agency, Nurse 28 with Doctor 27 the physician for Patient #8, indicated their office received faxes from the agency regarding missed visits, received no calls for verbal orders but received faxed Plans of Care for signature, and indicated the doctor was unaware comprehensive assessments/recertification visits were being done via telehealth. 410 IAC 17-14-1(a)(1)(G) 1. A review of an agency’s policy titled ‘MEDICAL SUPERVISION C645’ dated 09/2012 revealed, “ … 4. Physician will be contacted when any of the following occurs: a. Condition changes…d. caregiver support or home environment changes e. Any change in client condition or agency services … The results will be communicated with the physician for approval prior to making changes in the plan of care … 13. Agency responsibilities include: …. a. prompt reporting of a change in client condition b. Confidential and accurate communication about clients d. Periodic updates on client and condition/progress e. Time notification of change in condition …. ". 2. The review of the clinical record of Patient #5 on 09/22/2023 revealed a document titled ‘Pediatric Nursing Specialties of HCN-62, Form Type: Recertification’ dated 09/06/2023, electronically signed by corporate clinical administrator on 09-06-2023 which evidenced but not limited to, “ … height unable to measure … : telehealth pediatric cardiovascular … findings obtained and reported by SN (skilled nurse) Pediatric Head and Neck No problems identified Reported by SN Respiratory Tracheostomy Lung sounds clear in all fields per SN vital signs readings … obtained and reported by SN … interventions … assess patient vital signs every shift and PRN (as needed) … notify if temp [blank] … “. The agency failed to ensure the recertification assessment was completed accurately by a registered nurse. 3. On 09/27/2023 at 11:22 AM during an interview with Person 30, a RN (registered nurse) at Entity 32, indicated the ordering physician Person 31 for Patient #4 was not aware the recertification assessments were being performed via telehealth. 4. On 09/20/2023 at 4:48 PM, corporate clinical administrator indicated they are communicating with the physicians with any changes and telehealth visits.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure skilled nursing supervisory visits identified the nurse being supervised in 5 of 6 active clinical record reviews. (Patients #4, 5, 6, 7, and 8) Findings include: 5. A review of the clinical record of Patient #6 on 09-27-2023 revealed a nursing supervisory visit conducted on 02-13-2023, caregivers name was RN 1 and it is signed and dated by RN 1 on 02-13-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #6 on 09-27-2023 revealed a nursing supervisory visit conducted on 04-11-2023, caregivers name was the Corporate Clinical Administrator and it is signed and dated by the Corporate Clinical Administrator on 04-11-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #6 on 09-27-2023 revealed a nursing supervisory visit conducted on 06-09-2023, caregivers name was the Corporate Clinical Administrator RN and it is signed and dated by the Corporate Clinical Administrator on 06-09-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #6 on 09-27-2023 revealed a nursing supervisory visit conducted on 03-02-2023, caregivers name was the Corporate Clinical Administrator RN and it is signed and dated by the Corporate Clinical Administrator on 03-02-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. 6. A review of the clinical record of Patient #7 on 09-27-2023 revealed a nursing supervisory visit conducted on 03-21-2023, caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 03-21-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #7 on 09-27-2023 revealed a nursing supervisory visit conducted on 05-23-2023, caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 05-23-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #7 on 09-27-2023 revealed a nursing supervisory visit conducted on 07-18-2023, caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 07-18-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #7 on 09-27-2023 revealed a nursing supervisory visit conducted on 09-20-2023, caregivers name was RN 4 and it is signed and dated by RN 4 on 09-20-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. 7. A review of the clinical record of Patient #8 on 09-27-2023 revealed a nursing supervisory visit conducted on 03-02-2023, caregivers name was the Corporate Clinical Administrator RN and it is signed and dated by the Corporate Clinical Administrator on 03-02-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #8 on 09-27-2023 revealed a nursing supervisory visit conducted on 04-29-2023, caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 04-29-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #8 on 09-27-2023 revealed a nursing supervisory visit conducted on 06-29-2023, caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 06-29-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #8 on 09-27-2023 revealed a nursing supervisory visit conducted on 08-30-2023, caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 08-30-2023, evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. 8. On 09-20-2023 AM at 10:00 AM the Corporate Clinical Administrator stated, “I do telehealth supervisory visits” and indicated these had been done in person in the past. On 09-25-2023 at 1:43 PM, in a telephone interview with Person 20, a family member of Patient #3, indicated no supervisory visits occurred that they were aware of as no one asked him/her how the nurse on the case was doing, and suspects since no one asked, the nurses were supervising each other. On 09-27-2023 at 1:13 PM, when queried as to how supervisory visits are conducted for him/her, LPN 5 indicated the Corporate Clinical Supervisory will usually complete this at the same time as a virtual recertification visit, and is also done with audio only. On 09-27-2023 at 2:58 PM, when queried as to when the last supervisory visit for themselves would have been, LPN 6 indicated doesn’t think there has been one, and if there had been one it was done over the phone. 410 IAC 17-14-1(a)(1)(J)-RN 1. A review of an agency’s policy titled ‘SUPERVISION OF STAFF C-315 dated April 2022 revealed “POLICY All Staff providing home care services will be supervised as outlined by federal and state regulations and accepted standards of practice … 6. An RN {registered nurse] must observe a skill being performed and document the staff member’s competency in performance of a skill/task during supervisory visits when the staff member is present … Home Health Aide Staff … ". 2. A review of the clinical record of Patient #4 on 9/22/2023 revealed a PDN supervisory visit conducted on 4/14/2023 caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 4/14/2023 evidenced that the staff was not present for the visit, the staff demonstrated tasks were reported by family member, task/procedures were performed per protocols of HCN, safety with use of procedures and/or equipment. The supervisory visit failed to identify who was being supervised and with no staff/caregiver was available, corporate clinical administrator would not be able to assess tasks/procedures performed per protocols of HCN, safety use of procedures and/or equipment. A review of the clinical record of Patient #4 on 9/22/2023 revealed a PDN supervisory visit conducted on 06/12/2023 caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 06/12/2023 evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. A review of the clinical record of Patient #4 on 9/22/2023 revealed a PDN supervisory visit conducted on 08/14/2023 caregivers name was the corporate clinical administrator and it is signed and dated by the corporate clinical administrator on 08/14/2023 evidenced that the staff was present for the visit via telehealth. The agency failed to ensure the correct identity of the staff being supervised. 3. A review of the clinical record of Patient #5 revealed a PDN (Private Duty Nurse) supervisory visit conducted on 09/06/2023 signed by corporate clinical administrator , the caregiver was listed as the clinical corporate administrator, signature of patient/caregiver was written as “telehealth. The agency failed to ensure the correct identity of the staff being supervised. 4. On 09/27/2023 a 1:20 PM, the administrator indicated they weren’t sure why the supervisor is listed as the caregiver, there must be a glitch in the electronic medical record system, and they would have to check into that.

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure the supervising registered nurse made an on-site visit to the patient's home to observe and assess the aide performing care in 1 of 1 clinical records receiving home health aide services. (Patient #4) Findings include: A review of an agency’s policy titled ‘SUPERVISION OF STAFF C-315 dated April 2022 revealed “POLICY All Staff providing home care services will be supervised as outlined by federal and state regulations and accepted standards of practice … 6. An RN (registered nurse) must observe a skill being performed and document the staff member’s competency in performance of a skill/task during supervisory visits when the staff member is present … Home Health Aide Staff … 2. If clients are receiving only home health aide services and there is no skilled service provided, a Registered Nurse will make a supervisory visit while the aide is providing care at least once every 60 days …”. A review of the clinical record of Patient #4 on 9/22/23 revealed a home health certification and plan of care for the certification period of 08/15/2023 to 10/13/2023 diagnoses include but not limited to autistic disorder (a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave) and mild intermittent asthma (a condition in which a person's airways become inflamed, narrow and swell, and produce extra mucus, which makes it difficult to breathe and the asthma symptoms do not occur on a consistent basis and an individual can go through long periods without any symptoms). The patient is to receive home health aide respite services 12 to 16 hours per visit as needed. A review of the clinical record revealed a PDN (Private Duty Nurse) supervisory visit conducted on 2/11/23 signed by RN 3, the caregiver, is a family member providing home health aide services for Patient #4. The agency failed to ensure the supervisory visit was conducted by the supervisory nurse. On 09/27/2023 at 1:25 PM the corporate clinical administrator indicated they could not believe RN 3 performed their own supervisory visit, RN 3 knows they're not to do their own supervisory visits.

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 observation, record review, and interview the agency failed to ensure key Administrative positions were actively filled or designees assigned timely when vacancies existed, failed to ensure the integrity of the organizational structure, and failed to ensure all lines of authority were clearly established and current staff were aware of same. The governing body failed to ensure key Administrative roles were filled, and failed to ensure patients were receiving appropriate home health services (registered nurse not performing in-person comprehensive assessments) (G0942), the Administrator failed to be responsible for day to day operations of the agency (G0948), failed to ensure a Clinical Manager or alternate was available during operating hours and for survey activities (G0950), failed to ensure the Administrator or designee was available during all operating hours (G0956), and failed to ensure a Clinical Manager provided oversight of all patient care and personnel (G0958). 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 for all patients. .

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 record review and interview the Governing Body failed to assume full responsibility for the agency's overall management and operations related to the provision of skilled nursing services by the registered nurse, in relation to performing comprehensive assessments and supervisory visits via telehealth for 1 of 1 Governing Body. Findings Include: 1. Review of an agency document dated titled, ‘GOVERNING BODY-100’ stated, “POLICY The Governing Body shall assume full legal authority and responsibility for operation of Agency … Purpose to ensure lines of authority are established. To ensure clients are provided with appropriate, quality services … SPECIAL INSTRUCTIONS The duties and responsibilities of the Governing Body shall include: 1. ... Delegate to [Administrator] the authority and responsibility for the provision of home care services in accordance with state and federal regulations … 4. Adopt and periodically review and approve the administrative and personnel policies, client care policies and procedures …” Review of an agency document reviewed November 2011, titled, ‘POLICY DEVELOPMENT B-210’ stated, “POLICY Policies and procedures will … address significant operational areas of the agency. The policies will conform to the state and federal regulations … for home health … Selected policies and procedures will be reviewed and revised at least annually by the professional advisory committee. Other policies and procedures will be reviewed as defined by the organization and as needed based on review clinical managers and quality improvement committee. The governing body makes the final approval … SPECIAL INSTRUCTIONS ... 2. … New or revised policies will be approved ..." On 09-20-2023 at 10:50 AM, a requested agency document dated May 2023 titled, ‘Telehealth Services CI-941’ was received from the Corporate Clinical Administrator. This policy had not been approved by the Governing Body. 2. On 9-19-2023 at 2:36 PM, in an in-person interview, the Corporate Clinical Manager, based out of OHIO, indicated she was actively serving as the R.N. (Registered Nurse) Case Manager for Indiana and further indicated had been performing Recertification visits for patients via telehealth while a skilled nurse or parent was in the home. Indicated these were ‘video’ calls. When queried as who had given the directive for this practice, indicated the Corporate Operating Officer had. Further indicated this practice had been occurring since the agency lost two case managers at the end of 2022, but that she had been conducting telehealth visits on more regular basis since April of 2023. 410 IAC 17-12-1(b)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure the Administrator or their alternate was responsible for the day to day operation of the agency; failed to ensure staff were available during operating hours and for survey activities, failed to ensure comprehensive assessment visits were performed by a registered nurse, and failed to ensure supervisory visits for nursing staff were performed by a registered nurse, in 1 of 1 agency home health agency surveyed. Findings include: 2. On 9-19-2023 at 2:36 PM, in an in-person interview, the Corporate Clinical Manager, based out of Ohio, indicated she was actively serving as the R.N. (Registered Nurse) Case Manager for Indiana and further indicated had been performing Recertification visits for patients via telehealth while a skilled nurse or parent was in the home. Indicated these were ‘video’ calls. When queried as who had given the directive for this practice, indicated the Corporate Operating Officer had. Further indicated this practice had been occurring since the agency lost two case managers at the end of 2022, but that she had been conducting telehealth visits on more regular basis since April of 2023. On 09-20-2023 at 10:00 AM the Corporate Clinical Administrator stated, “I do telehealth supervisory visits” and indicated these had been done in person in the past. On 09-20-2023 at 4:43 PM, the Corporate Clinical Administrator and Corporate Person 2 indicated that comprehensive assessments and recertification visits should be done by an RN (Registered Nurse) in person. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1) 1. Review of an agency document dated April 04, 2014 titled, 'JOB DESCRIPTION: Clinical Administrator' stated, "POSITION SUMMARY Provides direction, coordination, supervision, and implementation of professional and supportive services to clients in safe, cost effective manner ... ESSENTIAL FUNCTIONS/AREAS OF ACCOUNTABILITY ... Planning ... 1. Plans, directs, and participates in delivery of professional services to home care clients ... Coordination of Services ... 1. Coordinates and directs programs and staffing to promote quality services for clients ... 6. Establishes and implements priorities for services within the limitations of available resources ... Policies and Procedures ... 1. Assures compliance with requirements of state licensure, Medicare certification, and compliance with regulatory agencies through policy and procedure development, staff education, and ongoing monitoring activities ..." Review of an agency document dated April 2022, titled, 'SUPERVISION OF STAFF C-315' stated, "POLICY All staff providing home care services will be supervised as outlined by federal and state regulations and accepted standards of practice PURPOSE To ensure staff is demonstrating competence in the area of communication, identifying and responding to clients needs, and performing procedures/techniques properly ..."

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure a Clinical Manager or alternate were in place, available during hours operation, and available for survey activities, in 1 of 1 home health agency surveyed. Findings include: 1. On 09-19-2023 at 8:55 AM, upon arrival to the agency, the office was found empty with no reply to knocking at the door. A note on the door stated, “PLEASE KNOCK FOR ASSISTANCE If we missed you we are out in the community caring for our patients. For immediate assistance, please call …” and indicated Administrative Staff Person A or the Corporate Clinical Administrator could be reached by phone. On 09-19-2023 at 2:00 PM, locksmith arrived on site and the Corporate Clinical Administrator and surveyors gained entry to the agency. 2. Review of an agency document, received 09-20-2023 at 8:30 AM, dated 2023 titled, ‘Organizational Chart’ failed to evidence the inclusion of the position of Clinical Manager or alternate. Review of updated agency document, received 09-21-2023, dated January 2023, at 1:50 PM, titled, ‘Home Care Network Pediatric Nursing Specialists [Entity B] HCN INDIANA N Organizational Chart’, and indicated the “RN (Registered Nurse) Supervisor” position was held by "x" and the position of “Alternate Supervisor” was held by "RN 1". Review of an agency document, received 09-27-2023, dated March 10, 2023 titled, ‘Minutes of the Annual Meeting of the Board of Directors/Governing Body and Administrator’ stated, “… The Board of Directors hereby approves: [Administrative Person 1] as the Administrator of [Entity 2, the Indianapolis location].” The conclusion of the document contained Administrative Person 1's type named and signature. 3. On 09-19-2023 at 8:58 AM, during a phone call, Administrative Person A indicated they were currently out of state related to bereavement. On 09-19-2023 at 8:59 AM, a phone call was made to the Corporate Clinical Administrator, a message was left informing State surveyors were currently at the agency and requested a call back. On 09-19-2023 at 9:27 AM, received a phone call from the Chief Operating Officer who indicated the Corporate Clinical Administrator was on her way and would arrive in approximately two (2) hours, as she was currently in the Dayton, Ohio area. On 09-19-2023 at 9:38 AM, during a phone call, the Chief Operating Officer, when queried as to who was the agency's Clinical Manager and whether there were any local staff who could gain entry to the agency, indicated had made sure everyone was being contacted. Indicated there was no Clinical Manager and that Administrative Person A was currently ‘covering’ as such, but was on PTO (Paid Time off) out of state, and indicated RN 1 was the Administrator. Further indicated would gather additional information, would find out availability of staff, in relation their schedules, and would call this surveyor back with more information. On 09-19-2023 at 9:55 AM, during a phone call, the Chief Operating Officer indicated RN 1 was unavailable as he/she was on a private duty nursing case this week and the Clinical Manager had resigned on August 10, 2023. On 09-19-2023 at 10:49 AM, during a phone call, the Corporate Clinical Administrator indicated she would be arriving at 1:00 PM and a locksmith had been called to gain entry into the office. When queried as to the need for a locksmith, indicated could not locate her own key and this needed to be done anyway, as building management also did not have a key. On 09-19-2023 at 2:03 PM, in an on-site interview, when queried as to who was Clinical Manager for the agency, the Corporate Clinical Administrator was unable to provide an answer but indicated would find out. On 09-20-2023 at 9:38 AM, the Corporate Clinical Administrator indicated the Clinical Manager was no longer with the agency. 410 IAC 17-12-1(d)

Available during all operating hours CFR(s): 484.105(b)(3) The administrator or a pre-designated person is available during all operating hours. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the agency failed to ensure an Administrator or alternate was in place, available during operating hours, and available for survey activities, in 1 of 1 home health agencies surveyed. Findings include: 1. On 09-19-2023 at 8:55 AM, upon arrival the agency, the office was empty and there was no reply to knocking at the door. A note on the door stated, “PLEASE KNOCK FOR ASSISTANCE If we missed you we are out in the community caring for our patients. For immediate assistance, please call …” and indicated Administrative Staff Person A or the Corporate Clinical Administrator could be reached by phone. On 09-19-2023 at 2:00 PM, locksmith arrived, the Corporate Clinical Administrator and surveyors gained entry to the agency. 2. Review of an agency document, received 09-20-2023 at 8:30 AM, dated 2023 titled, ‘Organizational Chart’ indicated Administrative Person 1 was the Administrator. Review of updated agency document, received 09-21-2023 at 9:30 AM, dated January 2023, titled, ‘Home Care Network Pediatric Nursing Specialist [Entity B] HCN INDIANA N Organizational Chart’ listed Administrative Person 1 as "Administrator" and and RN 1 was listed in the role of “Alternate Administrator”. 3. On 09-19-2023 at 8:58 AM, Administrative Person A, answered call and indicated they were currently out of state related to bereavement. On 09-19-2023 at 8:59 AM, a telephone call was made to the Corporate Clinical Administrator, a message was left informing State surveyors were currently at the agency and requested a call back. On 09-19-2023 at 9:27 AM, received a call from the Chief Operating Officer who indicated the Corporate Clinical Administrator was on her way and would arrive in approximately two (2) hours, as she was currently in the Dayton, Ohio area. On 09-19-2023 at 9:38 AM, the Chief Operating Officer was contacted and queried as to whether there were any staff locally who could help surveyors gain entry to the agency, indicated had made sure everyone was being contacted. Indicated Administrative Person A was on PTO (Paid Time off) out of state, but RN 1 was the Administrator. Indicated would gather additional information, would find availability of staff, in relation their schedules, and would call this surveyor back with more information. On 09-19-2023 at 9:55 AM, during a return phone call, the Chief Operating Officer indicated RN 1 was unavailable as he/she was on a private duty nursing case this week and the Clinical Manager had resigned on August 10, 2023. On 09-19-2023 at 10:49 AM, during a phone call, the Corporate Clinical Administrator indicated she would be arriving at 1:00 PM and a locksmith had been called to gain entry into the office. When queried as to the need for a locksmith, indicated could not locate her own key and this needed to be done anyway, as building management also did not have a key. On 09-19-2023 at 2:03 PM, when queried as to who was Administrator for the agency, the Corporate Clinical Administrator indicated this was RN 1 and Administrative Staff Person A was the alternate.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure a Clinical Manager or Alternate was in place, failed to establish new organizational structure, and failed to disseminate information of changes to remaining staff of same, in 1 of 1 agency surveyed. Findings include: 1. Review of an agency document, received 09-20-2023 at 8:30 AM, dated 2023 titled, ‘Organizational Chart’ failed to evidence the inclusion of the role of Clinical Manager or alternate. Review of updated agency document, received 09-21-2023 at 9:30 AM, dated January 2023, titled, ‘Home Care Network Pediatric Nursing Specialists [Entity 2, the Indianapolis office] Organizational Chart’ listed "x" served in the role of “RN (Registered Nurse) Supervisor” and RN 1 served in the role of “Alternate Supervisor”. 2. On 09-19-2023 at 9:38 AM, during a phone call, the Chief Operating Officer, when queried as to who was the agency's Clinical Manager, indicated there was no Clinical Manager and that Administrative Staff Person A was currently ‘covering’ as such, but was on PTO (Paid Time off) out of state, and indicated RN 1 was the Administrator. Further indicated would gather additional information and would call this surveyor back with more information. On 09-19-2023 at 9:55 AM, during a phone call, the Chief Operating Officer indicated RN 1 was unavailable as he/she was on a private duty nursing case this week and the Clinical Manager had resigned on August 10, 2023. On 09-19-2023 at 2:03 PM, in an on-site interview, when queried as to who was Clinical Manager for the agency, the Corporate Clinical Administrator was unable to provide an answer but indicated would find out. On 09-20-2023 at 9:38 AM, the Corporate Clinical Administrator indicated the Clinical Manager was no longer with the agency. 410 IAC 17-12-1(d)