Every finding on record at Forte Home Health Care Inc

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102 for a Home Health Provider and Suppliers. Survey Dates: August 5, 6, 7, and 8, 2024 Census: 100 At this Emergency Preparedness survey, Forte Home Healthcare was found to be in compliance with Conditions of Participation 42 CFR 484.102 Emergency Preparedness requirements for Medicare Participating Providers and Suppliers.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider. Survey dates: August 5, 6, 7, and 8, 2024. 12 Month Unduplicated Skilled Admissions: 38. Partially Extended Survey Announced on 08/06/2024 at 1:10 PM. This deficiency report reflects State findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. QR 8/16/24 A2

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the agency failed to provide services per the plan of care for 1 of 1 home observation of a patient in a group home (Patient #2). Findings include: 1. The plan of care policy received from the Administrator on 8/6/2024, indicated patients must receive the services identified in the plan of care. 2. An observation of a home health aide visit with Patient #2 occurred on 8/6/2024 at 7:45 AM. During an interview Home Health Aide (HHA) 4 indicated they see Patient #2 a couple of times a week. A review of the plan of care (POC) for Patient #2 indicated an order for aide services 6 hours a day, 7 days a week. During an interview on 8/6/2024 at 12:44 PM, HHA 4 indicated they saw Patient #2 “… a couple of days” a week for 4-6 hours each visit. When asked, HHA 4 indicated Person 5, identified as Patient #2’s guardian, decided which days and hours Patient #2 received services from HHA 4. During an interview on 8/6/2024 at 1:20 PM, the Administrator indicated Patient #2’s hours varied, based on the preference of the group home or guardian. The Administrator indicated Patient #2 should get more hours of care than they had been. During an interview on 8/8/2024 at 1:35 PM, Person 5 indicated the agency did not have staff available to provide all the hours Patient #2 had available. During an interview on 8/8/2024 at 2 PM, the Administrator indicated they had staff available to provide all the hours of care for Patient #2, but the group home /guardian refused to have those staff work. The Administrator indicated they did not decrease the hours as they did not want to lose them. 410 IAC 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the plan of care (POC) included all pertinent diagnoses for 1 of 5 active record reviewed with skilled nurse respite only services (Patient #8), and failed to ensure the POC included the correct strength of dosage for administration of medications for 3 of 5 active records reviewed with skilled nurse respite only services (Patient 8, 9, 10). Findings include: During a home observation with Patient #8 on 8/8/2024 at 9:30 AM, registered nurse (RN) 2 indicated the patient took two melatonin (a sleep aid) chews for a total of 6 milligrams (mg) at bedtime. A review of the plan of care (POC) medication list failed to identify the dosage of melatonin. RN 2 retrieved the bottle of melatonin which identified each chew as 5 mg. During an interview at the home visit, the Clinical Supervisor indicated the melatonin dosage should have been on the POC. Patient #8’s plan of care (POC) indicated diagnoses of Down’s syndrome, developmental delays, sleep apnea, hypogammaglobulinemia (a type of impairment in the immune system which increases the risk of infection), asthma, hypothyroidism, reflux, and a history of a Nissen procedure (surgery to eliminate reflux). The POC indicated an order for a chest percussion vest (mechanically vibrates the chest to loosen and thin mucus). During a home observation on 8/8/2024 at 9:30 AM, registered nurse (RN) 2 indicated Patient #8 required the vest due to pulmonary hypertension (a type of hypertension affecting the heart and lungs). The Clinical Supervisor indicated the pulmonary hypertension diagnosis should have been identified on the POC. Review of an agency policy titled “Medical Plan of Care” indicated the plan of care must include all pertinent diagnoses and medications. Review of the clinical record of Patient #9, included a POC for certification period 06/28/2024 – 08/26/2024 that indicated the skilled nurse may administer medications according to the orders. The POC indicated Calcium D3 (supplement of calcium and vitamin D) 1 capsule every day. The POC failed to evidence the strength of the dosage of Calcium D3. During an interview on 08/07/2024 at 2:05 PM, when asked what the strength of the dosage was for Calcium D3 capsule for Patient 9, the administrator indicated the strength was missing. Review of the clinical record of Patient #10, included a POC for certification period 06/21/2024 – 08/19/2024 that indicated the skilled nurse may administer medications according to the orders. The POC included the following medication orders: Vitamin C (supplement to maintain healthy skin, blood vessels, bones, and helps with wound healing) 2.5 ml daily, Zinc (helps immune system fight off bacteria and viruses) 0.5 ml daily, Vitamin D (helps grow and maintain bone) 1 drop with feedings, and Keppra 4 ml (manage seizures) twice a day. The POC failed to evidence the strength of the dosages of Vitamin C, Zinc, Vitamin D, and Keppra. During an interview on 08/07/2024 at 2:05 PM, when asked what the strength of the dosages was for Zinc, Vitamin C, Vitamin D, and Keppra for Patient 10, the administrator indicated the strengths were missing.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure written home health aide (HHA) care plans were developed by a registered nurse (RN) that included patient specific interventions for 2 of 4 active records reviewed of patients residing in own home (Patient #1, 4). Findings include: 1. Review of the clinical record for Patient #1 included a nursing plan of care reviewed by RN 1 on 06/06/2024 that included a HHA intervention to perform a bath (tub, shower, bed, sponge) of patient/family choice daily. During a home visit on 08/05/24 at 4:00 PM, when asked who gives Patient #1 a shower, HHA 1 indicated family member of Patient #1 is the only person who gives patient a shower. Patient #1 indicated only his/her family member gives him/her a shower, no one else. During an interview on 08/06/2024 at 10:12 AM, when asked who provides the bath for Patient #1, HHA 2 indicated family member of Patient #1. 2. Review of the clinical record for Patient #4 included a plan of care for certification period 07/11/2024 – 09/08/2024 that indicated an allergy to citrus fruits. Review of a nursing plan of care reviewed by RN 1 on 07/09/2024 included a HHA intervention to offer and assist with meals and snacks. The nursing plan of care failed to evidence a citrus fruit allergy. During an interview on 08/06/2024 at 11:20 AM, when asked what food allergies Patient #4 had, RN 1 indicated citrus fruits. When asked where that allergy can be found in the aide care plan, RN 1 indicated it wasn’t in there.

This was a federal recertification and state re-licensure home health survey with 1 complaint. The survey was announced as partially extended on 12/01/2021 at 3:00 PM. Complaint Number IN0029758: Substantiated; without findings Survey Dates: November 30; December 1,2,3,6,7 (2021) Facility Number: 012779 Provider ID: 15K086 Unduplicated Admissions for Past 12 Months: 129 Active Census: 107 These deficiencies reflect State Findings cited in accordance with 410 IAC 17.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure documentation of both the complaint and resolution was completed for 1 of 3 complaints reviewed in the 2021 complaint log (#8). Review of an agency policy dated 10/11/2018 titled “5.10 Client Rights and Responsibilities” indicated “… investigation of complaints … document both the existence of the complaint and the resolution of the complaint ….” Review of agency complaint log dated 2021 indicated patient #8 filed a complaint on 11/21/2021 with the administrator through iMessage (instant messaging service) regarding agency employees providing care who were not COVID 19 vaccinated. The administrator sent an email on 11/23/2021 with attachment of patient #8’s complaint to the clinical manager, alternate administrator, and vice president of operation. The agency failed to document the statement of the complaint, record of informal meeting, and resolution of the complaint. During an interview on 12/3/2021 at 1:00 PM, when asked for the agency follow-up with patient #8 regarding complaint, the administrator indicated they had discussed with patient the option of declining care from unvaccinated employees. When asked if the complaint form was completed, the alternate administrator confirmed it hadn’t been addressed. 410 IAC 17-12-3 (c)(2)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to complete a review of medications that included the potential for adverse reactions, drug interactions, and duplicate therapy for all records reviewed. 3. Clinical record for patient #2 was reviewed on 12/1/2021, start of care date 1/1/2013, certification period 11/28/2021-1/26/2022, with a primary diagnosis of moderate mental incapacity (cannot communicate on complex levels, may have difficulty in social situations, and problems with social cues and judgment), and other diagnosis (but not limited to), paraplegic cerebral palsy (decreased movement to legs). Review of a document titled “Comprehensive Nursing Assessment” dated 11/18/2021, indicated “… medication changes … yes … D/C (discontinue) Niacin (lower cholesterol); D/C Red Yeast Rice/CoQ10 (supplement); add Lipitor (lower cholesterol) 10mg QD (every day); add CoQ10 200mg cap (capsule) QD; add Lisinopril (lower blood pressure) 10mg QD ….” The comprehensive assessment failed to evidence a medication review for the potential for adverse reactions, drug interactions, and duplicate therapy. During an interview on 12/3/2021 at 1:15 PM, when asked where the documentation for the medication review could be found, administrator indicated this is done when medications are added but is not documented. 7. Clinical record for patient #6 (discharged record) was reviewed on 12/6/2021, start of care date 3/7/2021, certification period 7/5/2021-9/2/2021, with a primary diagnosis of cerebral palsy quadriplegia (decreased movement to arms and legs), and other diagnosis (but not limited to), seizures. Review of a document titled “ROC (resumption of care)/Health Care Provider Note” dated 6/3/2021, indicated “… began taking metformin (medication to treat high blood sugar levels) 500mg daily ….” Review of a document titled “Comprehensive Nursing Assessment” dated 6/3/2021, indicated “… medication changes … no ….” The comprehensive assessment failed to evidence a medication review for the potential for adverse reactions, drug interactions, and duplicate therapy. During an interview on 12/6/2021 at 3:40 PM, when asked where the documentation for the medication review could be found, administrator indicated it is not documented. 8. Clinical record for patient #7 (discharged record) was reviewed on 12/6/2021, start of care date 2/9/2020, certification period 2/3/2021-4/3/2021, with a primary diagnosis of cerebral palsy (affects ability to move and maintain balance and posture). Review of a document titled “Discharge Summary/Health Care Provider Note” dated 2/10/2021, indicated “… assessment completed via telehealth video chat … see updated medication list ….” Review of a document titled “Comprehensive Nursing Assessment” dated 2/10/2021, indicated “… medication changes … no ….” The comprehensive assessment failed to evidence a medication review for the potential for adverse reactions, drug interactions, and duplicate therapy. During an interview on 12/6/2021 at 3:50 PM, when asked where the documentation for the medication review could be found, administrator indicated it was not documented. 9. Clinical record for patient #8 was reviewed on 12/3/2021, start of care date 7/29/22018, certification period 11/10/2021-1/8/2022, with a primary diagnosis of multiple sclerosis (disease of the brain and spinal cord). Review of a document titled “Home Health Certification and Plan of Care” for certification period 11/10/2021-1/8/2022, indicated “… one new medication added to medication list … d/c (discontinue) previous atb (antibiotic) for UTI (urinary tract infection) ….” Review of a document titled “Comprehensive Nursing Assessment” dated 11/1/2021, indicated “… medication changes … no … done with abt ….” The comprehensive assessment failed to evidence a medication review for the potential for adverse reactions, drug interactions, and duplicate therapy. Review of a document titled “Progress/Health Care Provider Note” dated 11/1/2021, indicated “… one new medication added to medication list, and d/c previous atb for UTI ….” During an interview on 12/3/2021 at 1:25 PM, when asked where the documentation for the medication review could be found, administrator indicated agency must start documenting this. 10. Clinical record for patient #9 was reviewed on 12/3/2021, start of care date 8/12/2013, certification period 11/7/2021-1/5/2022, with a primary diagnosis of chromosomal anomalies (birth disorder that causes irregularities with extra or missing chromosomes which contain genetic information), and other diagnosis (but not limited to), legally blind, and impaired mobility (affects movement). Review of a document titled “Comprehensive Nursing Assessment” dated 11/1/2021, indicated “… medication changes … no ….” The comprehensive assessment failed to evidence a medication review for the potential for adverse reactions, drug interactions, and duplicate therapy. During an interview on 12/6/2021 at 3:35 PM, when asked where the documentation for the medication review could be found, administrator indicated it was not documented. 1. Review of a policy titled “Section 5 – Care Planning, Coordination of Services, Quality of Care, Client Documentation/Forms … 5.1 Comprehensive Assessments of Clients … must include … a review of all medications … to identify any potential adverse effects … drug interactions … [and] duplicate drug therapy….” 2. Record review for patient #1 was completed on 12/2/2021 for certification period 10/6/2021 – 12/4/2021, with a diagnosis of Duchenne’s muscular dystrophy (a genetic disorder causing progressive muscle weakness that eventually leads to death). Review of a document titled “Comprehensive Nursing Assessment” dated 10/29/2021, failed to identify a thorough review of the medications was completed. 4. Record review for patient #3 was completed on 12/1/2021 for certification period 10/15/2021 – 12/13/2021, with a diagnosis of traumatic brain injury (injury causing brain damage that results in physical, emotional, behavioral, and cognitive impairment in daily functioning). Review of a document titled “Comprehensive Nursing Assessment” dated 9/27/2021, failed to identify a thorough review of the medications was completed. 5. Record review for patient #4 was completed on 12/3/2021, for certification period 11/11/2021 – 1/9/2022, with a diagnosis of hydrocephalus (a buildup of fluid in the cavities deep within the brain, causing brain damage and including symptoms such as developmental delays, mobility, vision, coordination, bladder control problems; and change in personality). Review of a document titled “Comprehensive Nursing Assessment” dated 11/9/2021, failed to identify a thorough review of the medications was completed. 6. Record review for patient #5 was completed on 12/3/2021, for certification period 11/11/2021 – 1/9/2022, with a diagnosis of hydrocephalus (a buildup of fluid in the cavities deep within the brain, causing brain damage and including symptoms such as developmental delays, mobility, vision, coordination, bladder control problems; and change in personality). Review of a document titled “Comprehensive Nursing Assessment” dated 11/9/2021, failed to identify a thorough review of the medications was completed. 11. Record review for patient #10 was completed on 12/6/2021, for certification period 10/14/2021 – 12/12/2021, with a diagnosis of spinal muscular atrophy (genetic disorder resulting in muscle weakness that can include mobility, swallowing, and breathing issues due to poor muscle tone). Review of a document titled “Comprehensive Nursing Assessment” dated 10/13/2021, failed to identify a thorough review of the medications was completed.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated within the last 5 days of the 60-day period for 7 of 10 patients (#1, 2, 3, 6, 7, 8, 9), and failed to ensure the agency policy accurately represented the regulation. 1. Review of a policy titled “Section 5 – Care Planning, Coordination of Services, Quality of Care, Client Documentation/Forms … 5.1 Comprehensive Assessments of Clients … (d) … The comprehensive assessment must be updated and revised … Every 60 days (For OASIS [Outcome and Assessment Information Set, an assessment required for certain patients] patients, within the last 5 days of every 60 days ….” Record review for patient # 1 was completed on 12/2/2021 for certification period 10/6/2021 – 12/4/2021, with a diagnosis of Duchenne's muscular dystrophy (a genetic disorder causing progressive muscle weakness that eventually leads to death). Review of a document titled “Home Health Certification and Plan of Care” evidenced a certification period of 10/6/2021 – 12/6/2021. Review of a document titled “Comprehensive Nursing Assessment” evidenced a completion date of 10/29/2021, which was 2 days early for the certification period starting 10/6/2021. Record review for patient #3 was completed on 12/1/2021 for certification period 10/15/2021 – 12/13/2021, with a diagnosis of traumatic brain injury (injury causing brain damage that results in physical, emotional, behavioral, and cognitive impairment in daily functioning). Review of a document titled “Home Health Certification and Plan of Care” evidenced a certification period of 10/15/2021 – 12/13/2021. Review of a document titled “Comprehensive Nursing Assessment” evidenced a completion date of 9/27/2021, which was 13 days early for the certification period starting 10/15/2021. 3. Clinical record for patient #2 was reviewed on 12/1/2021, start of care date 1/1/2013. Certification period 9/29/2021-11/27/2021, evidenced a comprehensive re-assessment was required to be completed no earlier than 9/24/2021, but no later than 9/28/2021. The record failed to evidence a comprehensive re-assessment was completed or completed within the required timeframe. Review of a document dated and signed by RN (registered nurse) K on 9/21/2021 titled “Comprehensive Nursing Assessment” evidenced a nursing visit was completed on 9/21/2021. Review of a document dated and signed by RN K on 9/21/2021 titled “Supervisory and Reassessment Visit” indicated “… recertification condition update … will continue care per PCP (primary care physician) order ….” Certification period 11/28/2021-1/26/2022, evidenced a comprehensive re-assessment was required to be completed no earlier than 11/23/2021, but no later than 11/27/2021. The record failed to evidence a comprehensive re-assessment was completed or completed within the required timeframe. Review of a document dated and signed by RN (registered nurse) K on 11/18/2021 titled “Comprehensive Nursing Assessment” evidenced a nursing visit was completed on 9/21/2021. Review of a document dated and signed by RN K on 11/18/2021 titled “Supervisory and Reassessment Visit” indicated “… recertification condition update … will continue care per PCP order ….” During an interview on 12/3/2021 at 1:15 PM, when asked what the timeframe is for completing the comprehensive re-assessment for certification period, administrator indicated a supervisory visit and comprehensive re-assessment visit for skilled clients is done every 60 days. 5. Clinical record for patient #6 (discharged record) was reviewed on 12/6/2021, start of care date 3/7/2021, certification period 7/5/2021-9/2/2021, evidenced a comprehensive re-assessment was required to be completed no earlier than 6/30/2021, but no later than 7/4/2021. The record failed to evidence a comprehensive re-assessment was completed or completed within the required timeframe. Review of a document dated and signed by clinical manager on 6/3/2021 titled “Comprehensive Nursing Assessment” evidenced a nursing visit was completed on 6/3/2021. During an interview on 12/6/2021 at 3:40 PM, when asked what the timeframe is for completing the comprehensive re-assessment for certification period, administrator indicated non-skilled patients are seen every 30 days. 6.Clinical record for patient #7 (discharged record) was reviewed on 12/6/2021, start of care date 2/9/2020, certification period 2/3/2021-4/3/2021, evidenced a comprehensive re-assessment was required to be completed no earlier than 1/29/2021, but no later than 2/2/2021. The record failed to evidence a comprehensive re-assessment was completed or completed within the required timeframe. Review of a document dated and signed by clinical manager on 2/10/2021 titled “Comprehensive Nursing Assessment” evidenced a nursing visit was completed on 2/10/2021. During an interview on 12/6/2021 at 3:50 PM, when asked what the timeframe is for completing the comprehensive re-assessment for certification period, administrator indicated non-skilled patients are seen every 30 days. 7. Clinical record for patient #8 was reviewed on 12/3/2021, start of care date 7/29/22018, certification period 11/10/2021-1/8/2022, evidenced a comprehensive re-assessment was required to be completed no earlier than 11/5/2021, but no later than 11/9/2021. The record failed to evidence a comprehensive re-assessment was completed or completed within the required timeframe. Review of a document dated and signed by administrator on 11/1/2021 titled “Comprehensive Nursing Assessment” evidenced a nursing visit was completed on 11/1/2021. Review of a document dated and signed by administrator on 11/1/2021 titled “Supervisory and Reassessment Visit” indicated “… recertification condition update … will continue care per order ….” During an interview on 12/3/2021 at 1:25 PM, when asked what the timeframe is for completing the comprehensive re-assessment for certification period, clinical manager indicated would be completed in the 5-day window for skilled patients. 8. Clinical record for patient #9 was reviewed on 12/3/2021, start of care date 8/12/2013, certification period 11/7/2021-1/5/2022, evidenced a comprehensive re-assessment was required to be completed no earlier than 11/2/2021, but no later than 11/6/2021. The record failed to evidence a comprehensive re-assessment was completed or completed within the required timeframe. Review of a document dated and signed by clinical manager on 11/1/2021 titled “Comprehensive Nursing Assessment” evidenced a nursing visit was completed on 11/1/2021. During an interview on 12/6/2021 at 3:35 PM, when asked what the timeframe is for completing the comprehensive re-assessment for certification period, administrator indicated nonskilled patients are seen every 30 days.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all patients’ plans of care included (but not limited to) all equipment; all activities permitted; all medications and treatments; all safety measures; and measurable goals for 7 of 10 records reviewed (#2,4,5,6,7,8,9). 3. Record review for patient #4 was completed on 12/3/2021, for certification period 11/11/2021 – 1/9/2022, with a diagnosis of hydrocephalus (a buildup of fluid in the cavities deep within the brain, causing brain damage and including symptoms such as developmental delays, mobility, vision, coordination, bladder control problems; and change in personality). Review of a document titled “Home Health Certification and Plan of Care” for certification period 11/11/2021 – 1/9/2022, identified goals of “[Patient #4] will be assisted with transfers to help prevent falls for this certification period,” and “[Patient #4] will be monitored for falls through this certification period.” 4. Record review for patient #5 was completed on 12/3/2021, for certification period 11/11/2021 – 1/9/2022, with a diagnosis of hydrocephalus (a buildup of fluid in the cavities deep within the brain, causing brain damage and including symptoms such as developmental delays, mobility, vision, coordination, bladder control problems; and change in personality). Review of a document titled “Home Health Certification and Plan of Care” for certification period 11/11/2021 – 1/9/2022, identified goals of “[Patient #5] will be assisted dressing daily for this certification period,” and “[Patient #5] will be assisted with oral care daily through this certification period.” During an interview on 12/7/2021 at 11:20 am, the administrator confirmed these were not measurable goals. 1. Review of an agency policy dated 10/11/2018, titled “5.2 Medical Plan of Care” indicated “… the individualized plan of care must include … equipment required … activities permitted … medications and treatments … safety measures … measurable outcomes and goals ….” 2. Clinical record for patient #2 was reviewed on 12/1/2021, start of care date 1/1/2013, certification periods 9/29/2021-11/27/2021 and 11/28/2021-1/26/2022, with a primary diagnosis of moderate mental incapacity (cannot communicate on complex levels, may have difficulty in social situations, and problems with social cues and judgment), and other diagnosis (but not limited to), paraplegic cerebral palsy (decreased movement to legs). A home visit observation was conducted on 12/1/2021 at 9:00 AM with patient #2. During the visit, a walker was observed in the home. Family member indicated patient #2 walks short distances with the walker. Review of a document titled “Home Health Certification and Plan of Care” for certification periods 9/29/2021-11/27/2021 and 11/28/2021-1/26/2022, indicated “… DME (medical equipment) … walker … pain … uses Aleve (pain medication) prn (as needed) … medications … albuterol (medication to prevent and treat difficulty in breathing) … inhalation 1 unit dose (prepackaged dose used with a nebulizer, a machine that changes the solution to a fine mist and inhaled) … joint limitation … unable to ambulate (walk) … ." The plan of care failed to evidence use of a walker as an activity permitted, failed to evidence Aleve on the medication list, and failed to evidence the patient’s equipment included a nebulizer. Review of a document titled “Home Health Certification and Plan of Care” for certification period 9/29/2021-11/27/2021, indicated “… goals … will be assisted with … regular nut free diet for this certification period … will be monitored for choking through this certification period ….” The plan of care failed to evidence measurable outcomes and goals. Review of a document titled “Comprehensive Nursing Assessment” dated 11/18/2021, indicated “… medication changes … yes … D/C (discontinue) Niacin (lower cholesterol); D/C Red Yeast Rice/CoQ10 (supplement); add Lipitor (lower cholesterol) 10mg QD (every day); add CoQ10 200mg cap (capsule) QD; add Lisinopril (lower blood pressure) 10mg QD ….” Review of a document titled “Home Health Certification and Plan of Care” for certification period 11/28/2021-1/26/2022, indicated “… goals … will be monitored for seizures for this certification period … will beassisted [sic] with range of motio [sic] daily through this certification period … ….” This plan of care failed to evidence measurable outcomes and goals and failed to evidence the medication changes from 11/18/2021. During an interview on 12/3/2021 at 1:10 PM, when asked if a walker should be included under activities permitted in the plan of care, administrator indicated yes. When asked if Aleve should be included in the medication list in the plan of care, administrator indicated yes. When asked if the nebulizer should be included as medical equipment in the plan of care, administrator indicated yes. When asked if the current medication orders should be included in the plan of care, administrator indicated yes and clinical manager indicated since the home health aides don’t administer medication, the orders are not sent to physician until the next certification period. When asked if measurable goals specific to the patient should be included in the plan of care, administrator indicated yes. 5. Clinical record for patient #6 (discharged record) was reviewed on 12/6/2021, start of care date 3/7/2021, certification period 7/5/2021-9/2/2021, with a primary diagnosis of cerebral palsy quadriplegia (decreased movement to arms and legs), and other diagnosis (but not limited to), seizures. Review of a document titled “Home Health Certification and Plan of Care” for certification period 7/5/2021-9/2/2021, indicated “… goals … will be assisted with meals/snacks … for this certification period … will be monitored for seizures throughout this certification period … medications … seasonale (medication that decreases the number of menstrual cycles) ….” This plan of care failed to evidence measurable outcomes and goals and failed to evidence the route, dose, and frequency of the medication. During an interview on 12/6/2021 at 3:40 PM, when asked if measurable goals specific to the patient should be included in the plan of care, administrator indicated yes. When asked if the route, dose, and frequency of a medication order should be included in the plan of care, administrator indicated yes. 6. Clinical record for patient #7 (discharged record) was reviewed on 12/6/2021, start of care date 2/9/2020, certification period 2/3/2021-4/3/2021, with a primary diagnosis of cerebral palsy (affects ability to move and maintain balance and posture). Review of documents titled “SN (skilled nurse) Notes” dated 2/9/2021,2/23/2021, and 3/2/2021, indicated Fall Risk score of high risk. Review of a document titled “Home Health Certification and Plan of Care” for certification period 2/3/2021-4/3/2021, indicated “… Fall Management … at low risk for falls if he is safely positioned ….” The plan of care failed to evidence a patient specific safety measure. During an interview on 12/6/2021 at 3:50 PM, when asked why the fall risk in SN notes and the plan of care were different, clinical manager indicated the parent of patient #7 told SN the patient was a low fall risk. 7. Clinical record for patient #8 was reviewed on 12/3/2021, start of care date 7/29/22018, certification period 11/10/2021-1/8/2022, with a primary diagnosis of multiple sclerosis (disease of the brain and spinal cord). Review of a document titled “Home Health Certification and Plan of Care” for certification period 11/10/2021-1/8/2022, indicated “… medications … Xarelto (blood thinner) … goals … will be monitored for signs and symptoms of illness for this certification period … vitals will be taken as needed through this certification period ….” The plan of care failed to evidence bleeding precautions as a safety measure and failed to evidence measurable outcomes and goals. During an interview on 12/3/2021 at 1:25 PM, when asked if bleeding precautions should be included in safety measures when taking a blood thinner, administrator indicated yes. When asked if measurable goals specific to the patient should be included in the plan of care, administrator indicated yes. 8. Clinical record for patient #9 was reviewed on 12/3/2021, start of care date 8/12/2013, certification period 11/7/2021-1/5/2022, with a primary diagnosis of chromosomal anomalies (birth disorder that causes irregularities with extra or missing chromosomes which contain genetic information), and other diagnosis (but not limited to), legally blind, and impaired mobility (affects movement). A home visit observation was conducted on 12/2/2021 at 9:30 AM with patient #9. During the visit, a gait belt (assistive device used to safely transfer and walk an individual) was observed on patient #9 while home health aide assisted patient with walking in home. Review of a document titled “Home Health Certification and Plan of Care” for certification period 11/7/2021-1/5/2022, indicated “… goals … will be assisted ambulation to help prevent falls for this certification period [sic] … will be monitored for falls this certification period ….” The plan of care failed to evidence the patient’s equipment included a gait belt and failed to evidence measurable outcomes and goals. During an interview on 12/6/2021 at 3:35 PM, when asked if a gait belt should be included in the plan of care, administrator indicated yes. When asked if measurable goals specific to the patient should be included in the plan of care, administrator indicated yes. 410 IAC 17-13-1 (a)(1)(D)(ii,vii,ix,x,xiii)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure all staff followed standard precautions and infection control for 1 of 3 home visits observed (#9). Review of an agency policy dated 1/7/2020, titled “12.8 Hand Washing” indicated “… wash hands with soap and water ... after removing gloves ….” Review of an agency document dated 2021, titled “Continuing Education Infection Control” indicated “… basic rules for standard universal precautions are … wash hands before applying gloves and immediately after removing gloves ….” A home observation visit was conducted with HHA (home health aide) I on 12/2/2021 at 9:30 AM, with patient #9. HHA I was observed applying gloves, assisted patient with brushing teeth, rinsing mouth, washed face of patient, and removed gloves. Brushed patient’s hair and applied cologne per patient request. HHA I applied gloves, assisted patient with standing up from toilet and pulled up pants. Assisted patient with handwashing and drying of hands. HHA I removed gloves. Assisted patient with walking to couch, removed gait belt and provided patient with water. HHA I failed to perform hand hygiene (wash hands with soap and water or with hand sanitizer) after removal of gloves. During an interview on 12/3/2021 at 1:30 PM, when asked what the expectation is when employees remove gloves while providing care, administrator indicated washing hands or use of hand sanitizer.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, they agency failed to ensure the administrator reported to the governing body with no intermediaries. Reviewed a document provided by the agency as the organizational chart. The organizational chart indicated the administrator reported directly to the VP (vice president) of Operations, who reported to the president of the company. The president reported to the governing body. During an interview on 11/30/2021 at 3:35 PM, the president of the company confirmed the organizational chart described the current reporting structure. During an interview on 12/7/2021 at 11:15 AM, the VP of Operations confirmed the organizational chart needed to be updated.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the clinical manager failed to ensure the individualized plans of care included (but not limited to) HHA (home health aide) tasks and wound management in 4 of 10 records reviewed (#2,6,8,9). 1. Review of an agency policy dated 10/11/2018, titled “5.2 Medical Plan of Care” indicated “… individualized plan of care must specify the care and services necessary to meet the patient-specific needs … medications and treatments … integrate orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient ….” Review of an agency policy dated 10/11/2018, titled “5.3 Nursing Plan of Care” indicated “… nursing plan of care must contain … services to be provided ….” Review of an agency job description dated 1/16/2018, titled “Clinical Manager” indicated “assesses and assures the health … needs of the client are met in accordance with the Plan of Care … ensures orders are completed as needed ….” Review of an agency policy dated 10/11/2018, titled “10.5 Internal Quality Control Practices” indicated “… monitoring by the clinical manager … review documentation in home to assure compliance to standards ….” Review of an agency policy dated 10/11/2018, titled “10.6 External Quality Control Practices” indicated “… clinical manager … will make periodic presence in homes … review medical record for complete and accurate documentation ….” 2. Clinical record for patient #2 was reviewed on 12/1/2021, start of care date 1/1/2013, certification periods 9/29/2021-11/27/2021 and 11/28/2021-1/26/2022, with a primary diagnosis of moderate mental incapacity (cannot communicate on complex levels, may have difficulty in social situations, and problems with social cues and judgment), and other diagnosis (but not limited to), paraplegic cerebral palsy (decreased movement to legs). Review of documents titled “Appointment Information” completed by HHA’s with dates of 9/30/2021; 10/6/2021; 10/11/2021; 10/21/2021; 10/28/2021; 11/3/2021; 11/8/2021; 11/10/2021; and 12/1/2021, indicated “… caregiver notes … nail care done ….” Review of a document titled “Comprehensive Nursing Assessment” dated 10/21/2021, indicated “… notes … HHA … present/providing care as ordered ….” Review of a document titled “Progress/Health Care Provider Note” dated 10/21/2021, indicated “… supervisory visit … completed in client’s home … HHA … present and providing care as ordered ….” Review of a document titled “Comprehensive Nursing Assessment” dated 11/18/2021, indicated “… HHA … present and providing care to client as ordered ….” The clinical manager failed to ensure the HHA plan of care was updated to include the task of nail care. During an interview on 12/3/2021 at 1:15 PM, when asked if nail care, which had been documented as completed on numerous HHA visits, should be included in the plan of care, the administrator confirmed it should. 3. Clinical record for patient #6 (discharged record) was reviewed on 12/6/2021, start of care date 3/7/2021, certification period 7/5/2021-9/2/2021, with a primary diagnosis of cerebral palsy quadriplegia (decreased movement to arms and legs), and other diagnosis (but not limited to), seizures. Review of a document titled “Comprehensive Nursing Assessment” dated 6/3/2021, indicated “… skin integrity … wound to coccyx ….” Review of a document titled “ROC (resumption of care)/Health Care Provider Note” dated 6/3/2018, indicated “… continues to have wound to coccyx area ….” Review of a document titled “ROC/Health Care Provider Note” dated 7/19/2021, indicated “… has a wound vac placed on … coccyx ….” The clinical manager failed to ensure the plan of care was updated to include the wound care provided to patient #6. During an interview on 12/6/2021 at 3:40 PM, when asked where the wound care orders were documented, the administrator indicated the agency would not have orders because the agency did not provide the wound care. 4. Clinical record for patient #8 was reviewed on 12/3/2021, start of care date 7/29/22018, certification period 11/10/2021-1/8/2022, with a primary diagnosis of multiple sclerosis (disease of the brain and spinal cord). Review of a document titled “Home Health Certification and Plan of Care” dated 11/10/2021-1/8/2021, indicated “medications … Xarelto … for blood thinner ….” The clinical manager failed to ensure the HHA plan of care was updated to include bleeding precautions. During an interview on 12/3/2021 at 1:25 PM, when asked if bleeding precautions should be included in the plan of care, administrator indicated yes. Review of a document titled “Progress/Health Care Provider Note” dated 11/15/2021, indicated “… NCM (nurse case manager) notified that … client has a small open spot on upper buttocks ….” Review of a document titled “Progress/Health Care Provider Note” dated 11/16/2021, indicated “… NCM communicated with client about skin concern … client stated it is small like a paper cut ….” The clinical manager failed to ensure a nurse visit was made to assess the wound and failed to ensure the plan of care was updated to include the wound care necessary for patient #8. During an interview on 12/3/2021 at 1:25 PM, when asked if a nurse visit would be expected to assess the open area on the skin of a patient, the administrator indicated this would depend on the severity and patient had contacted physician and managing skin concern with this physician. 5. Clinical record for patient #9 was reviewed on 12/3/2021, start of care date 8/12/2013, certification period 11/7/2021-1/5/2022, with a primary diagnosis of chromosomal anomalies (birth disorder that causes irregularities with extra or missing chromosomes which contain genetic information), and other diagnosis (but not limited to), legally blind, and impaired mobility (affects movement). Review of documents titled “Individual Information” completed by HHA’s for dates of 11/7/2021 and 11/20/2021, indicated “… caregiver notes … put … AFOs (ankle foot brace) on ….” A home visit observation was conducted on 12/2/2021 at 9:30 AM with patient #9. During the visit, observed the HHA applying AFOs to patient’s left and right lower legs. The clinical manager failed to ensure the HHA plan of care was updated to include the task of applying AFOs.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included the time of medication administration and the effectiveness of as needed (PRN) medication in 1 out of 2 patients receiving skilled nursing services (#10). Record review for patient #10 was completed on 12/6/2021, start of care date 11/15/2015, for certification period 10/14/2021 – 12/12/2021, with a diagnosis of spinal muscular atrophy (genetic disorder resulting in muscle weakness that can include mobility, swallowing, and breathing issues due to poor muscle tone). Review of skilled nursing notes by RN M for 10/14/2021, 10/15/2021, 10/21/2021, 10/23/2021, 10/25/2021, 10/28/2021, 10/29/2021, 10/30/2021, 11/1/2021, 11/4/2021, 11/5/2021, 11/8/2021, 11/11/2021, 11/12/2021, 11/15/2021, 11/18,2021, 11/22/2021, 11/29/2021, and 12/2/2021, evidenced the administration of medications taken only “as needed” (PRN). Of 38 PRN medications administered by RN M on the dates listed, documentation of all 38 were missing the time of administration and the effectiveness of the medication. During an interview on 12/6/2021 at 3:30 PM, the administrator confirmed PRN medications required documentation of the time of administration and the effectiveness of the medication when administered by a nurse.