Every finding on record at Aaa Hoosier Home Healthcare Specialists Inc

An Emergency Preparedness survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Survey dates: March 10-14, 2025 and March 17, 2025 At this Emergency Preparedness survey, AAA Hoosier Home Healthcare Specialists, Inc., was found to be in compliance with 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: March 10-14, 2025 and March 17, 2025 Unduplicated Skilled Admissions for the last 12 Months: 78 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Complaint Survey, AAA Hoosier Home Healthcare Specialists, Inc. was found to be out of compliance with Conditions of Participation 42 CFR 484.55 Comprehensive assessment of patients and 42 CFR 484.60 Care planning, coordination of services, and quality of care. Based on the Condition-level deficiencies during the 03/17/2025 survey, your agency was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 03/12/2025. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 03/17/2025 and continuing through 03/16/2027. Abbreviations used in report: OT – Occupational Therapist, PT – Physical Therapist, POC – Plan of Care, CM – Clinical Manager, SOC - Start of Care, HHA - Home Health Aide, RN - Registered Nurse, LPN - Licensed Practical Nurse, SN - Skilled Nurse, ST- Speech Therapist

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 home health agency failed to ensure: the comprehensive assessment included the patient’s current health status (see tag G0528); the comprehensive assessment included a review of all patient medications (see tag G0536); the comprehensive assessment included the assessment of the caregiver’s willingness, ability, and availability to provide care (see tag G0538); and the comprehensive assessment was revised after a change in condition (see tag G0544). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) 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: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the comprehensive assessment was completed to include an assessment of pertinent information related to the care of the patient in 4 of 5 active clinical records reviewed. (Patient #1, 2, 3, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 01/31/2025, which indicated the Patient had a foley catheter (a plastic tube inserted into the bladder and held in place with a balloon to drain urine) and failed to include the assessment of the size of the balloon, patency, and the amount of urine draining. The comprehensive assessment indicated the patient had a midline intravenous catheter (a thin, flexible tube inserted into a vein in the arm to deliver medication) and failed to include an assessment of the size of the catheter, the length of the external catheter, and the location on the body where the midline was placed. On 03/12/2025, beginning at 2:22 PM, the CM indicated the comprehensive assessment failed to include the size of the foley catheter, the amount of draining urine, the size and location of the midline, and the the length of the external catheter length. 2. A clinical record review for Patient #2 evidenced a resumption comprehensive assessment dated 02/08/2025 which indicated the Patient had a foley catheter and failed to include the assessment of the size of the balloon, patency, and the quality and amount of urine draining. The comprehensive assessment indicated the Patient had a gastrostomy tube (GT, feeding tube surgically inserted into the abdominal wall and into the stomach) and failed to evidence the assessment included the appearance of the insertion site, if a dressing was present, and the patency and verification of the placement. The recertification assessment evidenced the Patient had a colostomy (a surgically created opening in the abdomen into the large intestine to direct stool out of the body) and failed to evidence the assessment included the appearance of the opening to the colostomy to include the color and if the opening was dry or moist and intact. On 03/12/2025, at 11:34 AM, the Alternate CM indicated the assessment of the foley size, patency, and amount and quality of the urine, the assessment of the GT insertion site and patency, and the assessment of the colostomy appearance were not included in the resumption comprehensive assessment 3. A clinical record for Patient #3 evidenced a start of care comprehensive assessment dated 02/23/2025 which indicated the Patient had a foley catheter and failed to include the assessment of the size of catheter and the balloon and the clarity and amount of urine draining. The assessment indicated the Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (open skin, partial thickness) to the left perineum (area between the anus and external genitalia) and the left knee and failed to include the assessment of the depth of the wounds. The assessment indicated the Patient had a pressure ulcer stage IV (open wound, full thickness exposing bone and/or tendon) to the right knee and failed to include the assessment of the depth of the wound and the tissue type of the wound bed. The assessment indicated the Patient had a GT and failed to include an assessment of the GT insertion site and if a dressing was in place. On 03/17/2025, at 1:17 PM, the CM indicated the comprehensive assessment did not include all of the specific patient information. 4. A clinical record review for Patient #5 evidenced a recertification comprehensive assessment dated 02/02/2025 which indicated the Patient had a pressure ulcer stage IV (full thickness, exposing bone and/or tendon) to the mid back with drainage, and the assessment failed to include the depth of the wound. The comprehensive assessment indicated the Patient had a tracheostomy (a hole surgically inserted into the throat and into the windpipe to assist with breathing) and failed to include the assessment of the type and size of the tracheostomy tube, the appearance of the site, and any dressing used. On 03/17/2025, beginning at 2:00 PM, the CM indicated the wound was open and the depth was not included in the assessment. On 03/17/2025, at 2:09 PM, the Alternate CM indicated the type and size of the tracheostomy tube and the appearance of the site was not included in the 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 record review and interview, the agency failed to ensure the comprehensive assessment included the assessment of drug interactions in 2 of 5 active clinical records reviewed. (Patient #1, 2) The findings include: 1. A clinical record review for Patient #1 evidenced A SOC comprehensive assessment dated 01/31/2025 completed by the CM which evidenced the nurse administered intravenous (into a vein) meropenem (antibiotic). The medication profile signed by the CM and dated 1/31/2025 failed to include meropenem and the SOC comprehensive assessment failed to include the assessment of the meropenem. On 03/12/2025, at 3:02 PM, the CM indicated the meropenem was not reviewed at the SOC comprehensive assessment if the medication was not included on the medication profile. 2. A clinical record review of Patient #2, SOC 10/19/2024, evidenced POC for certification periods 10/19/2024-12/17/2024, 12/18/2024-02/15/2025, and 02/16/2025-04/16/2025 which indicated the Patient’s medications included Eliquis (to thin the blood to treat/prevent blood clots), aspirin (to thin the blood to treat/prevent blood clots), dorzolamide (to treat high pressure in the eye), and levetiracetam (to treat seizures). The undated Drug-to-Drug interactions indicated a major drug interaction between Eliquis and aspirin and 2 moderate drug interactions between dorzolamide and aspirin and between levetiracetam and Eliquis. The SOC comprehensive assessment dated 10/19/2024 and the resumption comprehensive assessment dated 02/09/2025 failed to identify and assess the drug interactions. On 03/12/2025, at 11:58 AM, the Alternate CM indicated the drug interactions were not assessed at the comprehensive assessments.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the availability, capability, and ability of the caregiver was included in the comprehensive assessment in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 01/31/2025, which indicated the Patient had a foley catheter and a midline intravenous catheter (a thin, flexible tube inserted into a vein in the arm to deliver medication). The comprehensive assessment indicated the caregiver’s times varied and failed to evidence the ability, capability, and availability of the caregiver to meet the assessed needs. On 03/12/2025, at 3:00 PM, the Alternate CM indicated the comprehensive assessment did not specify the ability, capability, and availability of the caregiver for the Patient’s assessed needs. 2. A clinical record review for Patient #2 evidenced a resumption comprehensive assessment completed on 02/08/2025 which indicated the Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage IV (full thickness exposing bone and/or tendons) to the sacrum (lower back) requiring wound care, a gastrostomy tube (GT, feeding tube surgically inserted into the abdominal wall and into the stomach), and a foley catheter. The comprehensive assessment indicated the caregiver’s times varied and failed to evidence the ability, capability, and availability of the caregiver to meet the assessed needs. On 03/12/2025, at 12:09 PM, the Alternate CM indicated the comprehensive assessment did not specify the ability, capability, and availability of the caregiver for the Patient’s assessed needs. 3. A clinical record for Patient #3 evidenced a SOC comprehensive assessment dated 02/23/2025 which indicated the patient had 5 wounds requiring wound care, a foley catheter, and was dependent for personal care and medication administration. The comprehensive assessment indicated the caregiver’s times varied and failed to evidence the ability, capability, and availability of the caregiver to meet the assessed needs. On 03/17/2025, at 1:16 PM, the CM indicated the comprehensive assessment did not clearly identify the assessment of the caregiver. 4. A clinical record review for Patient #4 evidenced a SOC comprehensive assessment dated 02/18/2025 which indicated the Patient was dependent for personal care and medication administration. The comprehensive assessment indicated the caregiver’s times varied and failed to evidence the ability, capability, and availability of the caregiver to meet the assessed needs. On 03/17/2025, at 1:05 PM, the CM indicated the comprehensive assessment did not specify who the caregiver was and what was their ability and availability to provide care. 5. A clinical record review for Patient #5 evidenced a recertification comprehensive assessment dated 02/02/2025 which indicated the Patient had a pressure ulcer stage IV the mid back and a tracheostomy (a hole surgically inserted into the throat and into the windpipe to assist with breathing). The comprehensive assessment failed to asses the who the caregiver was and their willingness and ability to provide care as assessed.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to update and revise the comprehensive assessment based on changes in the patient’s condition in 1 of 1 active clinical record reviewed with increased pain resulting in a hold in services. (Patient #3) The findings include: The clinical record reviewed for Patient #3 evidenced a SOC comprehensive assessment dated 02/12/2025 and completed by the CM which indicated the Patient’s reported pain was 5 on a scale of 0-10 to the back and legs. Skilled nurse visit notes evidenced the Patient’s pain was 4/10 on 02/18/2025, 02/20/2025, 0/10 on 02/23/2025, 02/25/2025, 03/02/2025, 03/04/2025, 03/09/2025, and 03/11/2025. A PT visit dated 03/03/2025 evidenced the Patient reported pain with movement 8/10. A missed visit note dated 03/06/2025 and completed by PT 1 indicated the PT visit was cancelled due to the Patient’s pain and a communication note dated 03/11/2025 indicated PT services were on hold due to the Patient’s pain. During an observation of care at the Patient’s home on 03/13/2025, beginning at 3:12 PM through 4:38 PM, the Patient stated their pain was 10/10 to the right leg and hip and grimaced, moaned, and caught their breath while talking throughout the care provided by the CM as well as when lying still. The clinical record failed to evidence an updated comprehensive assessment related to the Patient’s pain. On 03/17/2025, at 1:39 PM, the CM indicated the comprehensive assessment had not been updated to reflect the change in Patient’s status related to pain resulting in the hold of PT services.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: the agency met the needs of the patient as assessed (See G0570); services were provided as directed in the plan of care (See G0572); the plan of care was individualized and included all medications, medical equipment and patient-specific interventions and goals (See G0574); services were provided only as ordered by the physician (See G0580); home health agency staff promptly alerted the primary care physician to changes in the patient’s condition (See G0590); the plan of care was revised as necessary (see G0592); and care was coordinated amongst the different disciplines / entities that provided care to agency patients (See G0606). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination, Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on observation, record review, and interview, the agency failed to meet the assessed needs in 2 of 5 active clinical records reviewed. (Patient #2, 3) The findings include: 1. A clinical record review for Patient #2 evidenced a referral dated 10/18/2024 which indicated the Patient’s diagnoses included hemiplegia (paralysis affecting one side of the body) of the right dominant side, history of a cerebral vascular accident (CVA, stroke), and aphasia (difficulty communicating) and included a physician order for home care services to include nursing, HHA, PT, ST, and OT to improve strength and speech. The undated and unsigned referral information document indicated the SOC was scheduled for 10/19/2024 and the ordered services were nursing, OT, and ST. The SOC comprehensive assessment dated 10/19/2024 completed by the Alternate CM indicated the Patient had right sided hemiplegia, was unable to respond verbally, was dependent for transfers, and bedbound. The SOC comprehensive assessment indicated the nurse coordinated care with the OT and ST. A communication note dated 10/18/2024 evidenced the Patient’s caregiver refused HHA and PT services but was accepting of nursing, OT, and ST services. The clinical record failed to evidence the agency provided OT and ST services. On 03/13/2025, at 7:09 AM, the Patient’s caregiver indicated they did not refused OT and ST services. On 03/12/2025, at 11:19 AM, the CM indicated she was unsure why OT and ST were not provided. On 03/12/2025, at 11:19 am, the Alternate CM indicated there was no documentation of communication with the physician related to the patient’s referral of the Patient’s refusal of PT and HHA services and no order to discontinue the referral of OT and ST. 2. During an observation of care on 03/13/2025, between 3:12 PM and 4:38 PM, at the home of Patient #3, the Patient was observed lying in bed with deformities to all 4 extremities. The Patient had limited use of their arms and hands and required total assist for rolling in bed. A clinical record review evidenced a start of care comprehensive assessment dated 02/23/2025 which indicated the Patient’s diagnoses included rheumatoid arthritis (a chronic disease primarily affecting the joints and causing pain, inflammation, and potential joint damage) and was dependent for bed mobility, transfers, and personal care and indicated the caregiver’s times varied. A referral document from Entity 1 evidenced a physician order dated 01/28/2025 which indicated home health was to provide a HHA. The POC for the initial certification 02/12/2025-04/12/2025 indicated HHA was to be provided 3 times a week for 9 weeks effective 02/25/2025. The record failed to evidence documentation for why the HHA order was not effective until 02/25/2025. A communication note dated 02/14/2025 indicated the HHA was on hold until 03/03/2025 per patient request. The clinical record failed to evidence documentation of the communication with the patient regarding the request to hold the HHA and who would be providing the patient’s personal care in the absence of the HHA. A document titled “Physician Order” dated 02/25/2025, which was not signed by the physician, indicated the HHA services were discontinued. A communication note dated 02/26/2025 indicated the Patient’s caregiver would train to become a HHA and work with the Patient and requested the agency place HHA services on hold until the training was completed. On 03/14/2025, at 2:25 PM, the Patient’s caregiver indicated neither the Patient nor the caregiver requested a hold or discontinuation of HHA services. The caregiver indicated HHA 1 was scheduled and did not show 3 times and indicated the agency never sent another HHA. The caregiver indicated they would take the training to become a HHA since the agency was not providing one. The caregiver indicated they had not yet completed the HHA training. On 03/17/2025, at 1:23 PM, the CM indicated she was unaware HHA 1 did not show for the care of the Patient. On 03/17/2025, at 1:23 PM, the Alternate CM indicated she would check into the HHA scheduling and why the HHA services were placed on hold. No additional information or documentation was provided by survey exit on 03/17/2025.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide services as directed in the POC in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record for Patient #3 evidenced a POC for the initial certification 02/12/2025-04/12/2025 which indicated the agency was to provide SN services 1 time a week for 1 week and then 3 times a week for 8 weeks for wound care for 5 wounds. The record failed to evidence the agency provided SN services 3 times a week for weeks of 02/16/2025 and 03/02/2025. The PT POC for certification period 02/12/2025-04/12/2025 evidenced the agency was to provide PT services 1 time a week for 1 week and then 2 times a week for 8 weeks effective 02/13/2025. The review failed to evidence the agency provided PT services since 03/03/2025. A missed visit note dated 03/06/2025 and completed by PT 1 indicated the PT visit was cancelled due to the Patient’s pain. A communication note dated 03/11/2025 indicated PT services were on hold due to the Patient’s pain. The record failed to evidence an order from the physician prior to 03/13/2025 to hold PT services. On 03/14/2025, at 2:24 PM, PT 1 indicated it was his decision to place PT services on hold due to the Patient’s pain and indicated he had not yet reached the physician to notify the physician of the Patient’s pain and request an order to hold PT services. On 03/17/2025, at 1:39 PM, the CM indicated there was no physician order prior to 03/13/2025 to hold PT services. On 03/17/2025, at 1:28 PM, the Alternate CM indicated the agency did not provide SN services 3 times a week for the weeks of 02/16/2025 and 03/02/2025. 2. A clinical record review for Patient #1 evidenced a POC for initial certification period 01/31/2025-03/31/2025 which indicated the agency was to provide HHA services 3 times a week for 9 weeks and failed to evidence the agency provided HHA services after 02/14/2025. On 03/12/2025, at 3:52 PM, the CM indicated there were some missed visits with the HHA since the agency was in transition to provide a different HHA. The CM indicated the family provided most of the personal care and there was not much for the HHA to do so the agency discontinued HHA services. The CM indicated there was not yet a physician order to discontinue HHA services. 3. A clinical record review for Patient #2 evidenced POC for recertification periods 12/18/2024-02/15/2025 and 02/16/2025-04/16/2025 which indicated the agency was to provide SN visits 3 times a week for 9 weeks and failed to evidence 3 SN visits the weeks of 01/19/2025 and 02/09/2025. On 03/12/2025, at 12:09 PM, the Alternate CM indicated the agency only provided 2 nurse visits the week of 01/19/2025 and 02/09/2025. The Alternate CM indicated there were no attempts by the agency to reschedule the missed visits. 4. A clinical record review for Patient #4 evidenced the POC for the initial certification period 02/18/2025-04/18/2025 which indicated the agency was to provide SN services 1 time a week for 9 weeks and PT services 2 times a week for 8 weeks effective 02/20/2025. The clinical record failed to evidence a SN visit the week of 02/23/2025 and PT visits since 02/20/2025. The electronic health record evidenced the PT visits were scheduled for PT 1 on 03/04/2025, 03/11/2025, and 03/13/2025 but no documentation of care was provided. On 03/17/2025, beginning at 1:09 PM, the Alternate CM indicated the agency did not provide a nurse visit the week of 02/23/2025 and was unsure why there was no documentation of PT visits since 02/20/2025 and was unsure if the visits were completed. A supplemental physician order dated 03/09/2025 indicated the nurse was to obtain a culture of the gastrostomy (GT, feeding tube surgically inserted into the stomach) site. The record failed to evidence the agency obtained the culture. On 03/17/2025, at 3:45 PM, the Alternate CM indicated the GT site culture had not yet been obtained. 5. A clinical record review for Patient #5 evidenced a POC for the recertification period 02/05/2025-04/05/2025 which indicated the agency was to provide SN and HHA services each 3 times a week for 9 weeks and failed to evidence 3 SN visits the weeks of 02/16/2025, 02/23/2025, 03/02/2025, and 03/09/2025 and failed to evidence 3 HHA visit the weeks of 02/02/2025, 03/02/2025, and 03/09/2025. On 03/17/2025, beginning at 2:07 PM, the Alternate CM indicated the agency only provided 2 HHA visits the week of 02/16/2025, 02/23/2025, 03/02/2025, and 03/09/2025 and indicated a verbal order was just obtained from the physician on 03/17/2025 to change the SN visit frequency to 2 times a week because the wound was healing. The Alternate CM indicated the agency did not provide 3 HHA visits the weeks of 02/02/2025, 03/02/2025, and 03/09/2025.

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 POC was developed to include all the medications, interventions, and measurable goals in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #2 evidenced a resumption comprehensive assessment dated 02/08/2025 which indicated the Patient would reach for the wound if the mitten was not worn. During an observation of care at the Patient’s home on 03/12/2025 beginning at 6:30 AM until 7:13 AM, a mitt was observed taped around the patient’s left wrist limiting the mobility and function of the left hand and fingers. A POC for recertification period 02/16/2025-04/16/2025 failed to evidence the use of the mitt to the left hand and the directions for use. A POC for recertification period 12/18/2024-02/15/2025 indicated the Patient had a wound vacuum (a medical device that uses negative pressure for wound healing) to the sacrum (lower back) for which the nurse was to perform wound vacuum dressing changes and failed to evidence the frequency of the wound vacuum dressing change. The POC indicated the Patient had a gastrostomy tube (GT, feeding tube surgically inserted into the abdominal wall and into the stomach) and indicated the nutritional requirement was enteral feeding (formula provided through the GT) and failed to evidence what the feeding type and amount was, the method of delivery (via pump or gravity), and the amount of water flushes daily. The POC indicated the Patient had a foley catheter (a plastic tube inserted into the bladder and held in place by an inflated balloon to drain urine from the body) and indicated the nurse was to change the catheter every 3 weeks. The POC failed to evidence to what size the nurse was to inflate the catheter. On 03/12/2025, at 11:55 AM, the CM indicated the mitt was not included in the POC. On 03/12/2025, beginning at 11:59 AM, the Alternate CM indicated the frequency of the wound vacuum dressing change, the size of the catheter balloon, the GT feeding and water flushes were not included in the POC. 2. A clinical record for Patient #3 evidenced a start of care comprehensive assessment dated 02/23/2025 which indicated the Patient had a foley catheter, a gastrostomy tube (GT, feeding tube surgically inserted into the abdominal wall and into the stomach), and 5 wounds requiring wound care. The POC for the initial certification 02/12/2025-04/12/2025 failed to include the size of the inflation of the foley catheter balloon and needed supplies for the foley catheter and failed to include interventions for the GT. The POC failed to include the frequency of wound care to be provided. On 03/17/2025, at 1:17 PM, the CM indicated the foley catheter balloon size, required catheter supplies, and interventions for the GT were not on the POC and was unaware they needed to be if the agency was not managing them. The CM indicated the frequency of the wound care was not included in the POC. 3. A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 01/31/2025, which indicated the Patient had a foley catheter and a midline intravenous catheter (a thin, flexible tube inserted into a vein in the arm to deliver medication). The SOC comprehensive assessment and SN visit notes dated 02/01/2025, 02/02/2025, and 02/07/2025 indicated the Patient used laxatives and/or enemas (medications to treat constipation). The POC for the initial certification period 1/31/2025-3/31/2025 failed to include interventions and goals related to the foley catheter and midline intravenous catheter and failed to include laxatives and/or enemas. On 03/12/2025, at 3:02 PM, the Alternate CM indicated the POC did not include interventions and goals related to the foley catheter and midline intravenous catheter. On 03/12/2025, at 3:05 PM, the CM indicated the caregiver indicated the Patient took Milk of Magnesia (medication for constipation) if needed and indicated the medication was not included in the POC. 4. A clinical record review for Patient #4 evidenced the SOC comprehensive assessment dated 02/18/2024 which indicated the Patient had home care services from Entity 3. The POC for the initial certification period 02/18/2025-04/18/2025 failed to include the home care services provided by Entity 3. On 03/17/2025, at 1:06 PM, the CM indicated Entity 3 provided personal care services 4-5 hours a day, 5 days a week which was not included in the POC. 5. A clinical record review for Patient #5 evidenced a POC for the recertification period 02/05/2025-04/05/2025 which indicated the Patient had a tracheostomy (a surgically created hole into through the neck and into the airway to assist with breathing), and the SN was to teach about the tracheostomy care and dressing, suctioning, and supplies needed but failed to include the type and size of the tracheostomy, specific care and dressing to the tracheostomy site, and suctioning orders. On 03/17/2025, at 2:11 PM, the Alternate CM indicated the interventions and supplies needed for the tracheostomy were not included in the POC.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide services only as directed by a physician in 3 of 5 active clinical records reviewed. (Patient #1, 2, 3) The findings include: 1. A clinical record review of Patient #2 evidenced POC for recertification period 12/18/2024-02/15/2025 which indicated the agency was to provide skilled nursing visits 3 times a week for 9 weeks. A physician order dated 01/31/2025 indicated the agency’s services were on hold due to the Patient’s hospitalization. The clinical record evidenced the agency resumed home health services on 02/08/2025 and provided SN services to include wound care on 02/08/2025, 02/13/2025 and 02/14/2025 without a physician order to resume home health services. On 03/12/2025, at 12:11 PM, the Alternate CM indicated there was no physician order to resume home health services until the recertification POC that began on 02/16/2025. 2. A clinical record review for Patient #1 evidenced the SOC comprehensive assessment dated 01/31/2025 and SN visit notes dated 02/01/2025 and 02/02/2025, all completed by the CM, which evidenced the nurse administered intravenous (into a vein) meropenem (antibiotic) and evidenced the nurse flushed the midline intravenous catheter (a thin, flexible tube inserted into a vein in the arm to deliver medication) with normal saline after antibiotic administration on 01/31/2025 and 02/02/2025. The clinical record failed to evidence a physician order for the IV antibiotic and normal saline flush. On 03/12/2025, beginning at 3:02 PM, the CM indicated she administered IV meropenem on 01/31/2025, 02/01/2025, and 02/02/2025 and thought she had seen the physician order for it but could not find it. 3. A clinical record review for Patient #3 evidenced a referral document dated 02/24/2025 from the Patient’s practitioner responsible for the POC, Person 2, which indicated the Patient had wounds to the abdomen and coccyx (lower back) and the wound care was to apply Silvadene cream (a wound ointment), apply silver alginate (an absorbent antimicrobial wound dressing), and cover with an island dressing. A wound order from Person 2 dated 02/24/2025 indicated the nurse was to provide wound care 3 times a week to include apply Silvadene, silver alginate, and an island dressing. The POC for the initial certification period 02/12/2025-04/12/2025 signed by the CM which indicated the Patient had 5 wounds and the nurse was to provide wound care to include applying a mepilex dressing (absorbent foam dressing for draining wounds). The POC was not signed by the physician and the record failed to evidence any specific communication with Other 2 to develop the POC to include the specific wound care. The SOC comprehensive assessment dated 02/12/2025 and completed by the CM and SN visit notes completed by LPN 1 dated 02/18/2025, 02/20/2025, 02/23/2025,02/25/2025, 03/02/2025, 03/04/2025, 03/09/2025, and 03/11/2025 indicated the nurse provided a mepilex dressing to all 5 wounds. The clinical record failed to evidence an order for the mepilex dressing. During an observation of care at the Patient’s home on 03/13/2025, beginning at 3:12 PM through 4:38 PM, the CM was observed providing wound care to the wounds to the abdomen, right knee, left knee, and mid back to include a mepilex dressing. On 03/17/2025, at 1:51 PM, the CM indicated after the SOC assessment, the agency contacted Person 2 to clarify the wounds and the orders but no additional order was found other than the order for Silvadene and silver alginate. The CM indicated the wound care provided to the Patient was always mepilex. On 03/17/2025, at 3:45 PM, the Alternate CM indicated there was no written physician order for the mepilex dressing. SN visit notes completed by LPN 1 dated 02/18/2025, 02/20/2025, 02/23/2025,02/25/2025, 03/02/2025, 03/04/2025, 03/09/2025, and 03/11/2025 evidenced the nurse obtained the Patient’s blood sugar. The clinical record failed to evidence a physician order for the obtaining of the blood sugar. On 03/17/2025, at 1:28 PM, the CM indicated the Patient indicated they did not have diabetes (a chronic disease that affects blood sugar) which was why the interventions on the POC did not include the nurse obtaining blood sugars.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide services as directed in the POC in 3 of 5 active clinical records reviewed. (Patient #1, 2, 3) The findings include: 1. A clinical record for Patient #3 evidenced the PT POC for certification period 02/12/2025-04/12/2025 which evidenced the agency was to provide PT services 1 time a week for 1 week and then 2 times a week for 8 weeks effective 02/13/2025. The review failed to evidence the agency provided PT services since 03/03/2025. A missed visit note dated 03/06/2025 and completed by PT 1 indicated the PT visit was cancelled due to the Patient’s pain. A communication note dated 03/11/2025 indicated PT services were on hold due to the Patient’s pain. The record failed to evidence the agency notified the physician of the Patient’s increased pain and need to hold PT services prior to 03/13/2025. On 03/14/2025, at 2:24 PM, PT 1 indicated it was his decision to place PT services on hold due to the Patient’s pain and indicated he had not yet reached the physician to notify them of the Patient’s pain and request an order to hold PT services. On 03/17/2025, at 1:39 PM, the CM indicated the physician was not notified of the Patient’s pain until after the home visit conducted on 03/13/2025. A document from Person 2, practitioner, dated 02/24/2025 indicated the active medications included tamsulosin (for enlarged prostate), lidocaine patch (for topical pain relief), and Celebrex (for inflammation and/or pain). The POC for the initial certification period 02/12/2025-04/12/2025 failed to evidence the Patient’s medications included tamsulosin, lidocaine, and Celebrex and failed to evidence any communication with Person 2 regarding the discrepancy of the medication lists. On 03/17/2025, at 1:56 PM, the CM indicated there was no specific documentation with Person 2 regarding the medication discrepancy. 2. A clinical record review for Patient #1evidenced a POC for initial certification period 01/31/2025-03/31/2025 which indicated the Patient was ordered to take 9 medications daily to include rivaroxaban (a blood thinner used to treat or prevent blood clots). The SOC comprehensive assessment dated 01/31/2025 and completed by the CM indicated the Patient only had 2 medications in the home which did not include rivaroxaban. A skilled nursing visit note dated 02/02/2025 and completed by the CM indicated the Patient did not yet have the rest of the ordered medications and was going to pick them up from the pharmacy on 02/03/2025. A SN visit note dated 02/07/2025 indicated the Patient could not afford the rivaroxaban. On 03/11/2025, at 5:10 PM, the Patient’s caregiver indicated the Patient still was not taking rivaroxaban because it was too expensive. The clinical record failed to evidence any communication with the physician regarding the Patient’s not following medication orders to include the rivaroxaban On 03/12/2025, beginning at 3:30 PM, the CM indicated she was not aware the Patient was still not taking rivaroxaban and indicated there was no documentation of communication with the physician since 2/13/2025 regarding the Patient not taking rivaroxaban as ordered. The SOC comprehensive assessment dated 01/31/2025 and skilled nurse visit notes dated 02/01/2025 and 02/02/2025, all completed by the CM, evidenced the nurse administered intravenous (into a vein) meropenem (antibiotic) via a midline intravenous catheter (a thin, flexible tube inserted into a vein in the arm to deliver medication). The clinical record failed to evidence the presence of the midline IV catheter after 02/02/2025 and failed to evidence a physician order to discontinue the midline IV catheter. On 03/14/2025, at 12:20 PM, the CM indicated the patient removed the midline IV catheter themselves and indicated there was no communication with the physician of the patient’s removal of the midline catheter. 3. A clinical record review for Patient #2, SOC 10/19/2024, evidenced POC for certification periods 10/19/2024-12/17/2024, 12/18/2024-02/15/2025, and 02/16/2025-04/16/2025 which indicated the Patient’s medications included Eliquis (to thin the blood to treat/prevent blood clots) and aspirin (to thin the blood to treat/prevent blood clots). The undated Drug-to-Drug interactions indicated a major drug interaction between Eliquis and aspirin, and the clinical record failed to evidence the agency notified the physician of the major drug interaction. On 03/12/2025, at 11:59 AM, the Alternate CM indicated she would look for documentation the agency notified the physician of the major drug interaction, but no documentation or information was provided prior to survey exit on 03/17/2025.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to revise the POC with changes in the patient’s care in 1 of 1 active clinical records reviewed with a tracheostomy (a surgically created hole in the neck and into the airway to assist with breathing). (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a SN visit note dated 02/10/2025 which indicated the Patient had increased sputum and required increased suctioning. The SN note indicated the ordering practitioner was going to call in an antibiotic to the pharmacy for the Patient to begin. The SN visit note dated 02/14/2025 indicated the Patient was taking Augmentin (antibiotic) for 10 days. The POC for recertification period 02/05/2025-04/05/2025 failed to evidence the POC was revised to include the antibiotic. On 03/17/2025, at 2:16 PM, the Alternate CM indicated the POC was not revised to include the antibiotic.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA provided tasks as directed in the care plan in 3 of 3 active clinical records reviewed with HHA services. (Patient #1, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a HHA Care Plan dated 01/31/2025 which indicated the HHA was to assist the Patient with a shower, lotion, hair care, shampoo, shave, and oral care every visit and was to report to the RN any refusal of care. HHA visit notes dated 02/05/2025 and 02/06/2025 indicated the Patient refused a shower, lotion, hair care, shampoo, oral care and refused a shave on 02/12/2025. The clinical record failed to evidence the HHA reported the Patient’s refusal of care as directed. On 03/12/2025, at 3:48 PM, the Alternate CM indicated the HHA did not provide the care as directed in the care plan, because the Patient refused the care because the HHA was a male. The Alternate CM indicated there was no documentation the HHA reported the refusal of care. 2. A clinical record review for Patient #4 evidenced a HHA Care Plan dated 02/18/2025 which indicated the HHA was to record the last bowel movement at every visit. HHA visit notes dated 02/25/2025, 02/27/2025, 03/01/2025, and 03/02/2025 failed to evidence the record of the last bowel movement as directed. On 03/17/2025, at 1:07 PM, the Administrator indicated the record of the last bowel movement was not completed. 3. A clinical record review for Patient #5 evidenced a HHA Care Plan dated 02/03/2025 which indicated the HHA was assigned to obtain the Patient’s temperature, pulse, respiration, and blood pressure and record the last bowel movement at every visit. The HHA visit notes dated 02/07/2025, 02/10/2025, 02/12/2025, 02/14/2025, 02/17/2025, 02/19/2025, 02/21/2025, 02/24/2025,02/26/2025, 02/28/2025, 0307/2025, 03/10/2025, 03/12/2025, and 03/14/2025 failed to evidence the HHA obtained the temperature, pulse, respiration, and blood pressure and failed to record the last bowel movement as directed. On 03/17/2025, at 2:07 PM, the Administrator indicated the agency did not typically have the HHA obtain vital signs (temperature, pulse, respirations, and blood pressure) and the HHA did not record the last bowel movement.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA supervision included the HHA followed the aide care plan in 3 of 3 active clinical records reviewed with HHA services. (Patient #1, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a HHA Care Plan dated 01/31/2025 which indicated the HHA was to assist the Patient with a shower, lotion, hair care, shampoo, shave, and oral care every visit and was to report to the RN any refusal of care. HHA visit notes dated 02/05/2025 and 02/06/2025 indicated the Patient refused a shower, lotion, hair care, shampoo, oral care and refused a shave on 02/12/2025. The clinical record failed to evidence the HHA reported the Patient’s refusal of care as directed. A HHA supervisory visit dated 02/14/2025 indicated the HHA provided services per the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 03/12/2025, at 3:50 PM, the CM indicated the agency did not provide supervision to the HHA in regards to the care following the care plan. 2. A clinical record review for Patient #4 evidenced a HHA Care Plan dated 02/18/2025 which indicated the HHA was to record the last bowel movement at every visit. HHA visit notes dated 02/25/2025, 02/27/2025, 03/01/2025, and 03/02/2025 failed to evidence the record of the last bowel movement as directed. A HHA supervisory visit dated 03/06/2025 indicated the HHA provided services per the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 03/17/2025, at 1:15 PM, the CM indicated there was no supervision of the HHA to ensure the care plan was followed and indicated the supervision form should not have been documented that the care was provided per the care plan. 3. A clinical record review for Patient #5 evidenced a HHA Care Plan dated 02/03/2025 which indicated the HHA was assigned to obtain the Patient’s temperature, pulse, respiration, and blood pressure and record the last bowel movement at every visit. The HHA visit notes dated 02/07/2025, 02/10/2025, 02/12/2025, 02/14/2025, 02/17/2025, 02/19/2025, 02/21/2025, 02/24/2025,02/26/2025, 02/28/2025, 0307/2025, 03/10/2025, 03/12/2025, and 03/14/2025 failed to evidence the HHA obtained the temperature, pulse, respiration, and blood pressure and failed to record the last bowel movement as directed. The HHA supervisory visit notes dated 02/14/2025, 02/27/2025, and 03/13/2025 indicated the HHA provided services per the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 03/17/2025, at 2:20 PM, the Alternate CM indicated the RN did not provide supervision to the HHA regarding the care not being followed per the care plan.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's 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). This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge plans were communicated to the physician in 1 of 1 closed clinical record reviewed. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced a discharge summary dated 5/6/2024, which indicated the patient was discharged from the agency on 4/30/2024 due to a change in payor source. Review failed to evidence the agency communicated with the physician regarding the patient’s payor source change and discharge from services. On 5/14/2024, at 1:33 PM, the Clinical Manager indicated she was unsure if there was any documentation of communication with the physician regarding the plan to discharge related to the patient’s payor source change. No additional documentation or information was provided prior to survey exit on 5/14/2024.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 3/18/2024 to 3/22/2024 Active Census: 49 At this Emergency Preparedness survey, AAA Hoosier Home HealthCare Specialists, Inc. was not found to be in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR: 3/31/24

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to create and implement individualized emergency preparedness plans for each patient in 3 of 4 home visits observed (#1, 2, 3). The findings include: 4. During observation of a home visit on 3/19/2024 at 7:00 AM, Patient #1's agency folder was reviewed and failed to evidence a completed emergency preparedness plan. During an interview on 3/19/2024 at 1:56 PM, the Clinical Manager indicated the nurse should have filled out the blank individualized emergency preparedness form and left it in the Patient's folder at the start of care. 1. Review of a policy titled “Disaster/Emergency Preparedness” dated 1/14/2021, indicated the agency was to orient the patient to emergency planning, evacuation routes, medications, and food/water and was to complete the individual emergency plan in the admission packet. 2. During an observation of care at the home of Patient #3 on 3/19/2024, at 4:20 PM, the agency admission packet was reviewed and the individual emergency plan was blank. On 3/20/2024, at 3:10 PM, the Clinical Manager indicated the individual emergency plan should be completed. 3. During an observation of care at the home of Patient #2 on 3/19/2024, at 9:12 AM, the agency admission packet was reviewed and the individual emergency plan was blank. 4. On 3/20/2024, at 3:10 PM, the Clinical Manager indicated the agency had not completed the individual emergency plans and should have completed them.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on record review and interview, the emergency preparedness plan failed to evidence procedures to follow up with on-duty staff and patients to determine services needed if there was an interruption of services due to an emergency in 1 of 1 agency. The findings include: A policy titled, "Disaster / Emergency Preparedness", last reviewed 9/12/2023, indicated during an emergency, the agency shall attempt to contact staff and patients to determine their need for services. The agency's response plan and task assignment sheets failed to evidence who was contacting on-duty staff and determining what patient services were needed. During an interview on 3/22/2024 at 11:40 AM, the Administrator indicated the plan failed to evidence who was contacting on-duty staff and determining what patient services were needed. The Administrator indicated they would use a staffing agency to attempt to meet patient needs during an emergency, but that was not included in their emergency plan.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (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]. This STANDARD is not met as evidenced by: Based on record review and interview, the emergency preparedness plan failed to evidence a specific communication plan for 1 of 1 agency. The findings include: A policy titled "Disaster / Emergency Preparedness", last reviewed 9/12/2023, indicated the Administrator / Clinical manager would attempt to notify appropriate staff and the staff will contact the office as soon as possible. A review of the agency's emergency preparedness binder failed to evidence a communication / phone tree indicating who was responsible for contacting whom in the event of an emergency. During an interview on 3/22/2024 at 11:55 AM, the Administrator indicated the emergency preparedness plan only contained a phone list, but failed to indicate who was responsible for contacting whom if the emergency plan were activated.

This visit was for a Federal Recertification and State Re-Licensure survey of a Home Health Provider in conjunction with 1 complaints. Survey Dates: 3/18/2024 to 3/22/2024 Complaint #: 105606 12-Month Unduplicated Skilled Admissions: 108 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Recertification Survey, AAA Hoosier Home HealthCare Specialists, Inc., was found to be out of compliance with Conditions of Participation at 42 CFR 484.50 Patient Rights, 42 CFR 484.55 Comprehensive Assessment of Patients, 42 CFR 484.60 Care Planning, Coordination, Quality of Care, 42 CFR 484.65 Quality Assessment / Performance Improvement, and 42 CFR 484.80 Home Health Aide Services. Based on the Condition-level deficiencies during the 3/22/2024 survey, AAA Hoosier Home Healthcare Specialists Inc. was subject to a fully extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 3/21/2024. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 3/22/2024 and continuing through 3/21/2026. QR: 4/01/24

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to electronically transmit the completed OASIS (Outcome and Assessment Information Set) assessment to the CMS (Centers for Medicare and Medicaid Services) system within 30 days of the completion of the patient assessment in 4 of 4 active clinical records reviewed with skilled services with a payor source of either Medicare or Medicaid. (Patient #1, 3, 4, 5) The findings include: 2. A clinical record review for Patient #1 evidenced a recertification OASIS assessment completed on 11/8/2023, which was not transmitted until 12/26/2023. 3. A clinical record review for Patient #4 evidenced a start of care OASIS assessment completed on 2/8/2024, which was not transmitted until 3/18/2024. 4. A clinical record review for Patient #5 evidenced a start of care OASIS assessment completed on 1/16/2014, which was not transmitted until 3/8/2024. On 3/22/2024, at 10:23 AM, the Clinical Manager indicated she was aware the OASIS transmissions were late and indicated the comprehensive assessment documentation is not timely which delays the transmission of the OASIS. 1. A clinical record review for Patient #3 evidenced a recertification OASIS assessment completed on 11/8/2023, which was not transmitted until 3/21/2024, and a recertification OASIS assessment completed on 1/3/2024, which was not transmitted until 3/21/2024. On 3/22/2024, at 10:23 AM, the Clinical Manager indicated she was aware the OASIS transmissions were late and indicated the comprehensive assessment documentation is not timely which delays the transmission of the OASIS.

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the patient was treated with respect (see tag G0428); the patient was informed in advance of the disciplines to provide service and the frequency of visits (see tag G0434); the discharge was appropriate because the physician responsible for the plan of care agreed that goals were met (see tag G0458); the agency made efforts to resolve patient/caregiver’s behavior in the home (see tag G0466); provide the patient/representative with contact information for other agencies (see tag G0468); and document the problem and efforts to resolve the problem in the clinical record (see tag G0470). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.50 Patient Rights.

Property and person treated with respect CFR(s): 484.50(c)(1) Have his or her property and person treated with respect; This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to ensure the patient was treated with respect in 1 of 2 home visits with a home health aide (HHA). (Patient #2) The findings include: During an observation of care at the home of Patient #2 on 3/19/2024, between 9:09 AM and 9:40 AM, HHA 2 was observed bathing the patient in the bed. Patient #2 was observed to be uncovered and exposed from head to toe during the duration of the bed bath. On 3/20/2024, at 3:57 PM, the Clinical Manager indicated the HHA should have covered the patient during the bed bath to maintain patient privacy. 410 IAC 17-12-3(b)(4)(B)

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients were informed of and consented to care and treatments provided in 3 of 5 active records reviewed (Patient #1, 3, 5). The findings include: * A clinical record review for Patient #3 evidenced a document titled “Consent [and] Verification of Receipt of Information” which indicated the disciplines to provide care and frequency of visits were to be entered which were left blank. Review failed to evidence the patient/caregiver were notified of the disciplines and frequency of services to be provided. On 3/20/2024, at 3:10 PM, the Clinical Manager indicated the consent form should have been completed to include the disciplines and the frequency as notification to the patient/caregiver prior to services being provided. 410 IAC 17-12-3(b)(2)(D)(i)(AA) 410 IAC 17-12-3(b)(2)(D)(i)(BB) 1. A review on 3/19/2024 of the clinical record for Patient #1, start of care 7/12/2023, failed to evidence consents for treatment. During an interview on 3/19/2024 at 1:52 PM, the Clinical Manager indicated the consents for treatment should have been included in the Patient’s record, but were not. 2. A clinical record review evidenced Patient #5 was admitted to home health on 1/16/2024 by the Alternate Clinical Supervisor for physical therapy services, but the initial physical therapy evaluation was not performed until 1/25/2024. A review of the record failed to evidence communication with the patient about the delay in starting therapy. During an interview on 3/21/2024 at 11:53 AM, the Alternate Clinical Supervisor indicated the Patient’s record failed to evidence why the physical therapist did not evaluate the patient until 1/25/2024. During an interview on 3/21/2024 at 10:20 AM, Patient #5 indicated they did not know why the nurse came out to do the start of care when they did not have a physical therapist available at that time. The Patient indicated they were not informed of the delay in starting therapy before consenting to home health services from the agency, nor were they updated by the agency.

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge was appropriate because the measurable goals in the plan of care were achieved and failed to ensure the physician responsible for the home health plan of care agreed that the patient no longer needed home health services in 1 of 1 closed record reviewed discharged for goals met. (Patient #7) The findings include: A clinical record review for Patient #7 evidenced a plan of care for certification period 11/14/2023-1/12/2024, which indicated the patient’s goals included the family would be able to safely provide care and the patient/caregiver would be able to administer medications effectively and safely. The discharge assessment completed by the Alternate Clinical Manager and dated 1/12/2024 the goals of effective and safe medication administration and ability of family to safely provide care were still in process. The discharge assessment indicated assistance was needed for supervision and safety and no caregiver was available. The discharge assessment indicated the patient required assistance with medication administration and failed to evidence which caregiver was responsible for providing medication assistance and the capability, availability, and willingness to provide assistance. On 3/20/2024, beginning at 11:40 AM, the Clinical Manager indicated the patient lived alone and had a caregiver that planned to stop in every day. The Clinical Manager indicated the patient was not safe due to diagnosis of dementia and needed someone to make sure he did not use the stove. On 3/22/2024, at 10:24 AM, the Alternate Clinical Manager indicated there was no documentation of the caregiver’s ability to administer medication safely and effectively. The Alternate Clinical Manager indicated she did not call the physician prior to discharge to discuss if the physician was in agreement with goals achieved and patient no longer needing home health care.

Make efforts to resolve the problem(s) CFR(s): 484.50(d)(5)(ii) (ii) Make efforts to resolve the problem(s) presented by the patient's behavior, the behavior of other persons in the patient's home, or situation; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to make efforts to resolve problems presented by the behavior of the caregiver in 1 of 1 patient records discharged for cause (Patient #6). The findings include: A clinical record review evidenced Patient #6 was discharged due to staff safety on 11/5/2023. A review of the clinical record failed to evidence efforts made to resolve problems leading to the discharge. During an interview on 3/20/2024 at 2:49 PM, the Clinical Manager indicated a family member who lived with the Patient was verbally aggressive and threatening to staff. The Clinical Manager indicated the Administrator spoke with the family member to attempt to resolve this problem. The Clinical Manager indicated she did not see any notes regarding this communication but would continue to look. By survey exit, no further documentation was received.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide the patient with contact information for other agencies in 1 of 1 patient records discharged for cause (Patient #6). The findings include: Based on record review and interview, the agency failed to make efforts to resolve problems presented by the behavior of the caregiver in 1 of 1 patient records discharged for cause (Patient #6). A clinical record review evidenced Patient #6 was discharged due to staff safety on 11/5/2023. A review of the clinical record failed to evidence the agency provided the Patient / caregiver contact information for other agencies. During an interview on 3/20/2024 at 2:49 PM, the Clinical Manager indicated due to the nature of the discharge, the agency did not provide the patient’s caregiver contact information for other agencies.

Document efforts to resolve problems CFR(s): 484.50(d)(5)(iv) (iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to document the problem and efforts to resolve problems in 1 of 1 patient records discharged for cause (Patient #6). The findings include: A clinical record review evidenced Patient #6 was discharged due to staff safety on 11/5/2023. A review of the clinical record failed to evidence documentation of staff complaints or concerns for safety in the home before the discharge order was written. The record failed to evidence efforts to resolve the problems prior to discharge. During an interview on 3/20/2024 at 2:49 PM, the Clinical Manager indicated a family member who lived with the Patient was verbally aggressive and threatening to staff. The Clinical Manager indicated the Patient’s record failed to evidence documentation of staff complaints or concerns for safety prior to the Patient’s discharge. The Clinical Manager indicated the Administrator spoke with the family member to attempt to resolve this problem. The Clinical Manager indicated she did not see any notes regarding this communication but would continue to look. By survey exit, no further documentation was received.

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 home health agency failed to ensure the initial assessment was completed within 48 hours of referral (See G0514), failed to ensure the comprehensive assessment included all pertinent information related to the care of the patient (See G528), failed to ensure the comprehensive assessment included a review of all patients' medications (See G0536), the comprehensive assessment included the ability, willingness, and availability of the caregiver (See G0538), and failed to ensure the comprehensive assessment was completed within 48 hours of the patient’s return home from a hospital admission (See G0548). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse failed to complete an initial assessment visit within 48 hours of referral in 3 of 4 active clinical records reviewed with a start of care date after the last survey on 5/20/2022. (Patient #3, 4, 5) The findings include: XX. A clinical record review evidenced the referral for home health services for Patient #4 was received by the agency on 1/25/2024. The nurse performed the start of care visit on 2/8/2024. During an interview on 3/19/2024, the Clinical Manager indicated the start of care visit should have been completed within 48 hours of accepting the referral. XX. A clinical record review evidenced the referral for home health services for Patient #5 was received by the agency on 1/8/2024. The Alternate Clinical Manager performed the start of care visit on 1/16/2024. A review of the Patient’s record failed to evidence documentation for the delay in the start of care. During an interview on 3/21/2024 at 11:35 AM, the Alternate Clinical Manager indicated she thought the start of care was delayed because there was something wrong with the patient’s phones. 1. A clinical record review for Patient #3 evidenced the patient’s referral for home health services was received on 6/27/2023 via fax and failed to evidence the initial visit was conducted until the start of care assessment completed on 7/12/2023. Review failed to evidence a reason for the delay in the initial visit. On 3/20/2024, at 3:09 PM, the Clinical Manager indicated the initial visit was done at the same time as the start of care assessment. The Clinical Manager indicated the referral paperwork was received on 6/27/2024 and was not sure why the initial visit was completed after 48 hours from the time of referral. The Clinical Manager indicated she would look for additional information, but no additional information was provided by survey exit on 3/22/2024. 410 IAC 17-14-1(a)(1)(A) 1. A clinical record review for Patient #3 evidenced the patient’s referral for home health services was received on 6/27/2023 via fax and failed to evidence the initial visit was conducted until the start of care assessment completed on 7/12/2023. Review failed to evidence a reason for the delay in the initial visit. On 3/20/2024, at 3:09 PM, the Clinical Manager indicated the initial visit was done at the same time as the start of care assessment. The Clinical Manager indicated the referral paperwork was received on 6/27/2024 and was not sure why the initial visit was completed after 48 hours from the time of referral. The Clinical Manager indicated she would look for additional information, but no additional information was provided by survey exit on 3/22/2024. 2. A clinical record review evidenced the referral for home health services for Patient #4 was received by the agency on 1/25/2024. The nurse performed the start of care visit on 2/8/2024. During an interview on 3/19/2024, the Clinical Manager indicated the start of care visit should have been completed within 48 hours of accepting the referral. 3. A clinical record review evidenced the referral for home health services for Patient #5 was received by the agency on 1/8/2024. The Alternate Clinical Manager performed the start of care visit on 1/16/2024. A review of the Patient’s record failed to evidence documentation for the delay in the start of care. During an interview on 3/21/2024 at 11:35 AM, the Alternate Clinical Manager indicated she thought the start of care was delayed because there was something wrong with the patient’s phones. 410 IAC 17-14-1(a)(1)(A)

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 observation, record review, and interview, the agency failed to ensure the comprehensive assessment was completed to include an assessment of pertinent information related to the care of the patient in 4 of 5 active clinical records reviewed. (Patient #2, 3, 4, 5) The findings include: 4. A review of the Resumption of Care visit on 2/8/2024 by the Alternate Clinical Manager evidenced Patient #4 had a PEG tube (feeding tube inserted through the abdomen), a foley catheter (a tube inserted through the urethra to drain urine), and a “JP drain (a surgical suction drain) to the back” but failed to evidence an assessment of each. The assessment indicated the patient very rarely or never has bowel incontinence and failed to evidence a pain assessment. During an interview on 3/19/2024 at 2:45 PM, the Alternate Clinical Manager indicated she did not perform a pain assessment because the patient did not speak. When asked how pain would be assessed for a non-verbal patient, the Alternate Clinical Manager stated, “I guess she can holler if she has pain”. The Alternate Clinical Manager indicated the comprehensive assessment failed to evidence an assessment of the PEG tube site, Foley catheter, and drain to the back. When asked why the patient had a drain in their back, the Alternate Clinical Manager indicated the patient had a cyst removed while in the hospital. During an interview on 3/19/2024 at 2:57 PM, the Clinical Manager indicated the drain to the back was probably a nephrostomy tube (a tube inserted to drain the kidney), and she would need to investigate it. The Clinical Manager indicated pain should have been assessed, even if the patient was non-verbal. During an interview on 3/20/2024 at 10:06, Person 2 (caregiver to Patient #4) indicated the Patient had been incontinent of stool since their hospitalization, and the tube in the Patient’s back was a nephrostomy tube, not a JP drain and the Patient did not have a cyst removed. 5. A review of the initial referral documents for Patient #5, received by the agency on 1/8/2024, evidenced wound care for a pressure ulcer on the Patient’s buttocks. In the start of care assessment dated 1/16/2024, in a section titled “Skin Condition”, the Alternate Clinical Manager indicated the Patient had no pressure ulcers. In a section titled, “Integumentary Assessment”, the Alternate Clinical Manager indicated the Patient had a pressure ulcer to their left stump (leg amputation), but failed to evidence any wound assessment. During an interview on 3/21/2024 at 11:53 AM, the Alternate Clinical Manager indicated she did look at the Patient’s buttocks during the assessment but did not recall seeing any wounds on the Patient. During an interview on 3/21/2024 at 1:39 PM, Patient #5 indicated they had a pressure ulcer to their buttocks when the start of care assessment was done, which had since healed, but the Alternate Clinical Manager did not look at it. The Patient indicated they were seated through the start of care visit, and they told the Alternate Clinical Manager about the wound, but she never assessed it. The Patient indicated they did not have a wound on their stump at or since their start of care. 410 IAC 17-14-1(a)(1)(B) 1. Review of a policy titled “Comprehensive Assessment of Patients” dated 1/14/2021, indicated the comprehensive assessment should incorporate all critical information and accurately reflect the patient’s status. 2. During an observation of care at the home of Patient #2 on 3/19/2024, between 9:01 AM and 9:50 AM, the patient was observed to have a tracheostomy tube (a plastic tube inserted into a surgically-created hole through the neck and into the windpipe to assist the patient in breathing) and a gastrostomy tube (a feeding tube surgically inserted into the abdomen into the stomach to provide nutrition, fluid, and/or medication), which was attached to tubing with white liquid attached to a pump with a display reading 110 milliliters (ml) per hour. A suction machine was observed on the patient’s shelf. The comprehensive assessment completed by the Clinical Manager on 2/14/2024, failed to evidence the assessment of the tracheostomy, the gastrostomy, the suction needs of the patient, the nutritional needs of the patient to include the amount of tube feeding, rate of infusion, frequency of tube feeding, and water flushes. The comprehensive assessment failed to include a vision and safety measures assessment. On 3/21/2024, at 1:22 PM, the patient’s caregiver indicated the patient received 300 ml of water via the gastrostomy three times a day and received oral suctioning and suction via the tracheostomy as needed for congestion. On 3/22/2024, at 10:58 AM, the Clinical Manager indicated the comprehensive assessment did not include an assessment of the gastrostomy, tracheostomy, feeding tube amount and frequency, water flushes, and safety measures. 3. During an observation of care at the home of Patient #3 on 3/19/2024, at 4:45 PM, Patient #3 indicated he/she had a continuous blood glucose monitoring device (a medical device inserted into the skin continuously) for months which sends his/her blood glucose level to his phone, and a device was observed attached to the patient’s left arm. A clinical record review evidenced a recertification comprehensive assessment completed by the Alternate Clinical Manager and dated 3/6/2024, which failed to include the assessment of the frequency and method of blood glucose monitoring and the patient’s ability to manage the device and change sites as required. On 3/22/2024, at 10:17 AM, the Alternate Clinical Manager did not include the assessment of the continuous blood glucose monitoring device because she was not aware the patient had one. 410 IAC 17-14-1(a)(1)(B)

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 nurse failed to ensure all patient medications were reviewed for potential adverse effects and drug interactions in 2 of 4 active records with observation of a home visit (Patient #1, 3). The findings include: * During an observation at the home of Patient #3 on 3/19/2024, at 4:45 PM, a bottle labeled “Flaxseed Oil 1000mg” was observed on the patient’s kitchen counter, which the patient indicated he/she had been taking daily for months. A clinical record review failed to evidence the medication profile and the drug review dated 3/20/2024 included flaxseed oil for potential side effects and interactions. During an interview on 3/20/2024, at 2:51 PM, the Clinical Manager indicated the flaxseed oil was not included in the drug review and indicated all medications, to include over the counter, should be included on the medication profile and drug review. The Clinical Manager indicated the skilled nurse should review all medications at every visit for any new or changed medications. 410 IAC 17-14-1(a)(1)(B) 1. A review on 3/19/2024 of the medication list from Facility 1, where Patient #1 resided, evidenced the following medications not included on the agency’s medication list: Calmoseptine (a topical moisture barrier), Nystatin (an anti-fungal), and Guaifenesin (a cough medicine). During an interview on 3/19/2021 at 1:41 PM, the Clinical Manager indicated Calmoseptine, Nystatin, and Guifenesin should have been included on the Patient’s list for medication review.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the availability, capability, and ability of the caregiver was included in the comprehensive assessment in 1 of 5 active clinical records reviewed. (Patient #3) The findings include: A clinical record review for Patient #7 evidenced a recertification comprehensive assessment completed by the Alternate Clinical Manager and dated 3/6/2024, which indicated the patient was diabetic (a disease that affects the blood sugar) and required regular blood sugar checks and insulin (an injectable medication used to lower blood sugar) administration. The assessment indicated the patient had a caregiver willing to provide care. The assessment failed to include if the caregiver was able to provide the required diabetic care and the availability of the caregiver. On 3/22/2024, at 10:17 AM, the Alternate Clinical Manager indicated she was unsure if the caregiver was able to provide the care related to the patient’s diabetes and did not know the patient’s availability.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to complete a comprehensive assessment within 48 hours of returning home in 1 of 1 active patient records reviewed with a hospitalization (Patient #4). The findings include: A review of communication notes in the clinical record evidenced Patient #4 was discharged from a 5-day hospital stay on 2/29/2024, and the resumption of care visit was performed by the Alternate Clinical Manager on 3/4/2024. During an interview on 3/19/2024 at 2:45 PM, the Alternate Clinical Manager indicated she did not know why she did not see the patient within 48 hours of discharge home from the hospital, but she should have.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to implement a discharge planning process that followed agency policy and informed the patient and physician of potential discharge in 1 of 2 closed clinical records reviewed. (Patient #7) The findings include: Review of a policy titled “Discharge/Transfer from Service” dated 1/14/2021, indicated the agency would notify appropriate agency staff and attending physician of intent to discharge. A clinical record review for Patient #7 indicated the patient was discharged on 1/12/2024 due to goals met. The most recent skilled nurse visit note prior to discharge completed by LPN 1 and dated 1/3/2024, which indicated the LPN planned to educate on dementia at the next visit. Review failed to evidence communication with the LPN and the physician regarding to intent to discharge. On 3/22/2024, at 10:26 AM, the Alternate Clinical Manager indicated the agency’s documentation was a problem and there was not any documented communication with the physician and staff regarding to upcoming discharge.

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 the discharge summary content included all necessary information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences to the physician in 2 of 2 closed clinical records reviewed (Patient #6, 7). The findings include: 3. A clinical record review for Patient #6 evidenced a discharge summary dated 11/5/2023 which failed to include the patient’s health status at time of discharge, summary of services provided by the agency, instructions given to the patient/responsible party, and post-discharge goals of care. During an interview on 3/20/2024, at 2:49 PM, the Clinical Manager indicated the discharge summary should include the patient's health status, services provided, discharge instructions, and progress toward goals, but did not. 1. Review of a policy titled “Discharge/Transfer from Service” dated 1/14/2021, indicated the discharge summary was to include the patient’s health status at time of discharge, summary of services, and instructions given to the patient/responsible party. 2. A clinical record review for Patient #7 evidenced a discharge summary dated 1/18/2024 which failed to include the patient’s health status at time of discharge, summary of services provided by the agency, instructions given to the patient/responsible party, and post-discharge goals of care. On 3/22/2024, at 10:32 AM, the Clinical Manager indicated the reason for discharge and patient follow-up with the physician should be included in the discharge summary. The Clinical Manager indicated the current discharge summary template did not include all of the required items and she would submit a ticket to the electronic health record program to have the template updated.

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 home health agency failed to ensure: the agency met the patient needs (See G0570), the plan of care was individualized and followed by all agency staff as directed by the primary care physician (See G0572), the plan of care contained all medications, medical equipment and patient-specific interventions and goals for their patients (See G0574), services were provided only as ordered by the physician (See G0580),the plan of care was reviewed by the physician at least every 60 days (See G0588), the home health agency staff promptly alerted the primary care physician to changes in the patients condition (See G0590), and failed to ensure there was coordination of care amongst the different disciplines / entities that provided care to agency patients (See G0606). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination, Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on observation, record review and interview, the agency failed to meet the patient's needs in 2 of 2 patients with a history of pressure ulcer to the buttocks (Patient #1, 5). The findings include: 1. Observation of a home visit for Patient #1 on 3/19/2924 at 7:00 AM, LPN (licensed professional nurse) 1 failed to assess the skin on the Patient's buttocks. Patient was observed to have limited mobility, required assistance to transfer from wheelchair to a chair, and used an adult an incontinence brief. A clinical record review evidenced the Patient had a history of a pressure ulcer to the buttocks, was chair bound, and incontinent of urine. During an interview on 3/19/2024 at 7:47 AM, the Alternate Clinical Manager, who observed the home visit, indicated the LPN did not need to assess the patient's skin on their buttocks because the nurse is only to do what they are there for, which for this Patient was care of a wound to the chest. The Alternate Clinical Manager indicated the staff at Assisted Living 1 would let them know if the Patient developed a new wound. During an interview on 3/19/2024 at 1:37 PM, the Clinical Manager indicated the nurse should have performed a complete head-to-toe assessment, including visualizing the skin on the patient's buttocks. 2. A review of the initial referral documents for Patient #5, received by the agency on 1/8/2024, evidenced wound care for a pressure ulcer on the Patient’s buttocks. In the start of care assessment dated 1/16/2024, in a section titled “Skin Condition”, the Alternate Clinical Manager indicated the Patient had no pressure ulcers. During an interview on 3/21/2024 at 11:53 AM, the Alternate Clinical Manager indicated she did look at the Patient’s buttocks during the assessment but did not recall seeing any wounds on the Patient. During an interview on 3/21/2024 at 1:39 PM, Patient #5 indicated they had a pressure ulcer to their buttocks when the start of care assessment was done, which had since healed, but the Alternate Clinical Manager did not look at it. The Patient indicated they were seated through the start of care visit, and they told the Alternate Clinical Manager about the wound, but she never assessed it.

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 ensure each patient received services as written in an individualized plan of care in 3 of 7 records reviewed (Patient #1, 4, 7). The findings include: * A clinical record review for Patient #7 evidenced plans of care for certification period 1/8/2024-3/7/2024 and 3/8/2024-5/6/2024, which indicated the agency was to provide physical therapy (PT) services 2 times a week for 8 weeks. Review failed to evidence the agency provided PT services 2 times during the weeks of 3/3/2024 and 3/10/2024. On 3/20/2024, at 3:04 PM, the Clinical Manager indicated she did not see 2 visits weekly by the PT during the weeks of 3/3/2024 and 3/10/2024 but would look. No additional information was provided before survey exit on 3/22/2024. 1. A policy titled “Physician Orders / Plan of Care”, last reviewed 9/12/2023, indicated the plan of care should be specific to the patient condition and needs. 2. The observation of a home visit on 3/19/2024 evidenced Patient #1 resided in a Memory Care unit and failed to evidence LPN (Licensed Practical Nurse) 1 provide patient or staff teaching. A review of the plan of care for Patient #1, certification period 3/8/2024 to 5/6/2024, evidenced the following interventions: instruct in disease process, instruct in factors that will precipitate complications, teach medication scheduling, teach use of medication administration record, evaluate knowledge of medication actions / side effects, and evaluate knowledge of medication administration. During an interview on 3/19/2024 at 1:53 PM, the Clinical Manager indicated the plan of care was not individualized to the patient, and it should say the nurse would educate the caregiver. The Clinical Manager indicated the nurse should have talked to the nurse at the facility about the patient’s medications in order to educate them. 3. A review of the plan of care for certification period 2/8/2024 to 4/7/2024 evidenced Patient #4 was to receive home health aide visits 5 days per week. A clinical record review failed to evidence the patient received home health aide visits from 3/9/2024 through 3/14/2024. During an interview on 3/20/2024 at 10:06 AM, Person 2 (caregiver to Patient #4) indicated the agency did not send an aide for about a week because of staffing issues.

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 included all required components in 4 of 5 active records reviewed (Patients #1, 2, 3, 4). The findings include: * During an observation of care at the home of Patient #3 on 3/19/2024, between 4:06 PM and 4:50 PM, a cane was observed next to the patient hanging on the chair. At 4:41 PM, the patient indicated he had not taken insulin (an injectable medication used to lower blood sugar) in almost 2 months. On 3/20/2024, at 1:19 PM, Patient #3 indicated he had not taken Januvia (a medication used to lower blood sugar) in almost a year, had not taken meloxicam (a medication used to treat pain and inflammation) in “years”, and had not taken furosemide (a medication used to remove excess fluid) and potassium (a supplement) in over a year. Patient #7 indicted he received outpatient infusion treatments of Ocrevus (a medication used to treat Multiple Sclerosis; a disease affecting the nerves causing pain, fatigue, and impaired coordination) twice a year. A clinical record review of the plan of care for certification period 3/8/2024-5/6/2024, completed by the Alternate Clinical Manager, failed to evidence the medical equipment included a cane. The plan of care indicated the medications included, but were not limited to, tizanidine as needed and failed to include the as needed indications; insulin 2 times a day; meloxicam daily; furosemide daily; potassium daily; and Januvia daily. The plan of care failed to evidence the Ocrevus infusions. The plan of care indicated the safety measures included bleeding precautions and failed to evidence a medication that increased the risk of bleeding. On 3/20/2024, beginning at 2:50 PM, the Clinical Manager indicated tizanidine was to be used as needed for muscle spasms and the plan of care should include all medication indications. The Clinical Manager indicated all medical equipment should be included on the plan of care and indicated the bleeding precautions should be removed from the plan of care since the patient did not have an increased risk of bleeding. The Clinical Manager indicated the skilled nurse should review all medications at every visit and ask the patient about any new or changed medications. On 3/20/2024, at 2:55 PM, the Alternate Clinical Manager indicated she was not aware of the medication changes and indicated she was the nurse case manager for the patient who completed the last comprehensive assessment on 3/6/2024. * During an observation of care at the home of Patient #2 on 3/19/2024, between 9:01 AM and 9:50 AM, the patient was observed to have a tracheostomy tube (a plastic tube inserted into a surgically-created hole through the neck and into the windpipe to assist the patient in breathing) and a gastrostomy tube (a feeding tube surgically inserted into the abdomen into the stomach to provide nutrition, fluid, and/or medication). A suction machine (a medical device used to suction secretions) was observed on the patient’s shelf. A clinical record review evidenced a plan of care for certification period 2/15/2024-4/14/2024, which failed to include gastrostomy tubing, tracheostomy supplies, and suction machine and supplies in the medical supplies. The plan of care failed to evidence the tracheostomy to include the type, size, site care, and who was managing the tracheostomy care and failed to evidence the suction required. The plan of care indicated the medications included, but were not limited to, Keppra (seizure medication), doxazosin (medication used to treat an enlarged prostate), and bromocriptine (medication used to lower the growth hormone). On 3/21/2024, at 1:22 PM, the patient’s caregiver indicated the patient received 300 ml of water via the gastrostomy three times a day and received oral suctioning and suction via the tracheostomy as needed for congestion. The patient’s caregiver indicated the patient received Albuterol (a medication used for shortness of breath) as needed via nebulizer (a medical device used to administer inhaled medications), Keppra was discontinued over a year ago, doxazosin had been discontinued in “awhile”, and bromocriptine was discontinued in 1-2 years ago. On 3/22/2024, beginning at 10:40 AM, the Clinical Manager indicated the agency did not care for the tracheostomy so the plan of care did not include information about the tracheostomy and indicated it should be included. The Clinical Manager indicated the plan of care should include suction and water flush orders. The Clinical Manager indicated she was the case manager and completed the plan of care and comprehensive assessment and did not look at the medications to reconcile what medication changes had taken place and indicated the correct medication orders should be included in the plan of care. 410 IAC 17-13-1(a)(1)(D)(ii, viii, ix, x, xiii) 1. A review of the plan of care for certification period 3/8/2024 to 5/6/2024 failed to evidence Facility 1 provided medication administration as well as bathing and other ADL’s (activities of daily living) for Patient #1. The plan of care evidenced the Patient took Bisacodyl (a laxative) 1 suppository as needed, Polyethylene Glycol (a laxative) daily as needed, and Ondasetron (an anti-nausea) every 8 hours as needed, but failed to evidence a frequency for the Bisacodyl and an indication for use of the three medications. During an interview on 3/19/2024 at 1:15 PM, the Clinical Manager indicated the plan of care failed to include what services were being provided by Facility 1. The Clinical Manager indicated the plan of care failed to include the frequency for all medications as well as an indication for use of each as needed medication. 2. Observation of a home visit on 3/20/2024 at 12:10 PM evidenced Patient #4 had a PEG tube (feeding tube inserted through the abdomen) infusing a feeding via a pump, a foley catheter (a tube inserted through the urethra to drain urine), and a nephrostomy tube (a tube inserted to drain the kidney) A review of the plan of care for certification period 2/8/2024 to 4/7/2024 failed to evidence what feeding the patient was receiving and how it was given, PEG tube site care, foley catheter care, and nephrostomy tube care. During an interview on 3/19/2024 at 2:57 PM, the Clinical Manager indicated the plan of care failed to evidence the tube feeding, PEG tube site care, foley catheter care and nephrostomy tube care.

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 were provided only as ordered by the physician in 2 of 3 active clinical records reviewed with more than 1 certification period. (Patient #2, 3) The findings include: 1. A clinical record review for Patient #3 evidenced the agency was to provide skilled nursing services weekly for patient education and assessment and physical therapy 2 times weekly effective 9/10/2023. The plan of care for certification period 9/10/2023-11/8/2023 was signed by the physician on 10/17/2023 and failed to evidence a signed physician order for services since 10/17/2023 until the plan of care for certification period 11/9/2023-1/7/2024 was signed by the physician on 3/20/2024. The plans of care for certification periods 1/8/2024-3/7/2024 and 3/8/2024-5/6/2024 failed to evidence a physician signature. On 3/21/2024, at 11:25 AM, the Alternate Clinical Manager indicated she was the case manager for the patient and completed the comprehensive assessments and plans of care. The Alternate Clinical Manager indicated she did not call the physician for orders to recertify the patient and continue the plan of care at time of recertification for the period 3/8/2024-5/6/2024. The Alternate Clinical Manager indicated orders for continuation of care are provided when the physician signs the plan of care. On 3/21/2024, at 11:33 AM, the Clinical Manager indicated physicians should be notified at time of recertification if home health care was to continue and obtain a verbal order. The Clinical Manager indicated there was no physician order since the plan of care for certification period 9/10/2023-11/8/20233 was signed by the physician on 10/17/2023 until the plan of care for 11/9/2023-1/7/2024 was signed by the physician on 3/20/2024. 2. A clinical record review for Patient #2 evidenced a plan of care for certification period 2/15/2024-4/14/2024, which was signed by the physician on 2/21/2024, and indicated the agency was to provide home health aide services 5 times weekly. Review failed to evidence a physician order for recertification and continuation of the plan of care after the previous certification period ended on 2/14/2024 before the physician signed the plan of care for the certification period beginning on 2/15/2024 on 2/21/2024. On 3/22/2024, at 10:49 AM, the Clinical Manager indicated there was not a verbal order obtained for the continuation of care for the plan of care for the certification period that began on 2/15/2024, prior to the physician signing the plan of care on 2/21/2024. 410 IAC 17-13-1(a)(1)

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was reviewed by the physician at least every 60 days in 2 of 3 active clinical records reviewed with more than 1 certification period. (Patient #2, 3) The findings include: 1. A clinical record review for Patient #3 evidenced the plan of care for certification period 9/10/2023-11/8/2023 was signed by the physician on 10/17/2023 and failed to evidence the agency sent the plan of care for certification period 11/9/2023-1/7/2024 to the physician until 3/20/2024, which was greater than 60 days. Review indicated the agency did not send the plan of care for certification period 1/8/2024-3/7/2024 to the physician until 3/21/2024. 2. A clinical record review for Patient #2 evidenced the plan of care for certification period 8/19/2023-10/17/2023 was signed by the physician on 8/18/2023 and failed to evidence the agency sent the physician the plan of care for certification period 10/18/2023-12/16/2023 until 1/10/2024, which was greater than 60 days. 3. On 3/21/2024, at 11:33 AM, the Clinical Manager indicated she was unsure why there was a delay in the agency sending the plans of care to the physician and indicated it could have been because of corrections to the plan of care. The Clinical Manger indicated the physician should be sent and review the plan of care at least every 60 days. 410 IAC 17-13-1(a)(2)(D)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to alert the physician to changes in the patient’s condition in 4 of 5 active records reviewed (Patient #1, 3, 4, 5). The findings include: * A clinical record review for Patient #3 evidenced lab results dated 12/6/2023, which indicated abnormal values for 4 blood tests and 2 urine tests. Review indicated the lab tests were ordered by and communicated to Person #4 and failed to evidence the agency reported the abnormal lab values to the physician responsible for the plan of care, Person #5. On 3/22/2024, at 10:15 AM, the Clinical Manager indicated she would check to see if there was any documentation Person #5 was notified of the abnormal lab values and indicated the lab results should have been faxed to Person #5. No additional information was provided by survey exit. 410 IAC 17-13-1(a)(2)(D)( 1. A review of the plan of care for certification period 3/8/2024 to 5/6/2024 indicated Patient #1 was a fall risk and would benefit from physical therapy. A clinical record review evidenced a PT (physical therapy) evaluation was performed on 3/13/2024 with no subsequent PT visits. A review of the record failed to evidence the physician was informed that the agency was not providing PT. During an interview on 3/19/2024 at 1:59 PM, the Clinical Manager indicated the physical therapist should have communicated with the physician that Patient #1 was not a candidate for therapy because they did not consistently follow directions. 2. A review of the plan of care for certification period 2/8/2024 to 4/7/2024 indicated Patient #4 was to be evaluated for PT (physical therapy). A clinical record review evidenced a PT evaluation was performed on 2/9/2024 with no subsequent PT visits. A review of the record failed to evidence the physician was informed that the agency was not providing PT. During an interview on 3/19/2024 at 2:10 PM, the Clinical Manager indicated the physical therapist should have communicated with the physician that Patient #4 was not a candidate for therapy because they could not follow directions. 3. A review of an occupational therapy note dated 3/7/2024 evidenced Patient #5’s blood pressure was 161/102. A review of the clinical record failed to evidence the physician was notified of the elevated blood pressure. During an interview on 3/21/2024 at 12:05 PM, the Clinical Manager indicated the occupational therapist should have either informed the physician directly or contact her so she could contact the physician, and document the communication in the record, but they did not.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on observation, record review and interview the agency failed to coordinate patient care in 3 of 3 active records receiving care from another agency (Patient #1, 2, 3). The findings include: * A clinical record review for Patient #3 evidenced a plan of care for certification period 3/8/2024-5/6/2024, which indicated the patient received home health aide services from Entity 3. Review failed to evidence any communication from Entity 3 for the purpose of care coordination. On 3/20/2024, at 3:00 PM, the Clinical Manager indicated the agency had sent their plan of care to Entity 3 but had not received anything back from Entity 3. The Clinical Manager indicated care coordination should be conducted at every recertification with each entity providing care to the patient. * A clinical record review for Patient #2 evidenced a comprehensive assessment dated 2/14/2024, which indicated the patient received respite services from Entity 6 and failed to evidence care coordination had been completed since 4/28/2023. On 3/22/2024, at 10:48 AM, the Clinical Manager indicated she would look for any additional care coordination, and no additional information was provided by survey exit. 410 IAC 17-12-2(h) 1. A policy titled “Coordination of Patient Care”, last reviewed 9/12/2023, indicated the agency should coordinate care with all others providing care for the patient, and all coordination of care should be documented in the patient record. 2. Observation of a home visit at Facility 1 on 3/19/2024 at 7:00 AM failed to evidence LPN (Licensed Practical Nurse) 1 coordinate care for Patient #1 with staff from the Facility. A review of the clinical record for Patient #1 failed to evidence coordination of care with Facility 1. During an interview on 3/19/2024 at 7:19 AM, LPN 1 indicated she rarely saw a nurse at Facility 1, and she could call the Facility if she needed to talk to the nurse about the Patient. During an interview on 3/19/2024 at 1:56 PM, the Clinical Manager indicated the nurse should coordinate care with the Facility nurse at the visit and document the coordination in the patient’s record. After reviewing the record, the Clinical Manager indicated it failed to evidence the nurse coordinated care with Facility 1.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the governing body approved the detail of the data collection, failed to evidence the quality assessment and performance improvement (QAPI) program utilized quality indicator data to include OASIS (Outcome and Assessment Information Set) data to identify opportunities for improvement, failed to evidence the QAPI program focused on high risk areas, failed to evidence the agency implemented performance improvement actions and documented a quality improvement project with the reason the project was chosen and the measurable progress on the project. The findings include: A review of the agency’s QAPI program and Governing Body Minutes dated 2/4/2024 failed to evidence the governing body approved the detail of the data collection. Review failed to evidence the reason for the selection of the performance improvement project and its measurable outcomes. The patient discharge list for the past 6 months indicated 9 of the 34 discharges were due to patient request equaling 26% of patient discharges. Review of the QAPI program failed to evidence any data related to and actions taken to address the patient request to discharge. The “Performance Summary” report dated October 2023 indicated the agency had a higher percentage of negative change than the agency’s cohort group in the following areas: toilet transferring, ambulation, bathing, toilet hygiene, and feeding. Review failed to evidence any improvement activities for the areas of higher negative change. The “Final Achievement Thresholds and Benchmarks” report dated October 2023 indicated the agency scored less than the agency’s cohort group in the following areas: patients discharged to the community, improvement in dyspnea (difficulty breathing), and improvement in oral medication management and indicated the agency reported higher acute care hospitalizations and emergency department use than its cohort group. Review failed to evidence performance improvement activities in the areas addressed in the benchmark report. The hospitalization data indicated there were 4 patient hospitalizations, 5%, out of a census of 85 in Quarter 3 of 2023 and indicated there were 9 patient hospitalizations, 14%, out of a census of 66. Review failed to evidence the QAPI program focused on the hospitalization data to include tracking and trending. The active patient roster indicated 6 of the 49 (12%) active patients had wounds. The QAPI program failed to include data related to the wounds. On 3/22/2024, beginning at 11:53 AM, the Administrator indicated the governing body did not approve the detail of the data to be collected and indicated there was no documentation of why the performance improvement project was selected and its measurable outcomes. The Administrator indicated the percentage of patient discharges related to patient request was not addressed in QAPI and was mostly due to staffing. The Administrator indicated there were no performance improvement actions for Quarter 3 and Quarter 4 of 2023 and indicated the QAPI program had not yet addressed the areas underscored in the OASIS measures. The Clinical Manager indicated patients with wounds were considered high risk and indicated the QAPI program did not include wound data and performance improvement activities. The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation 42 CFR §484.65 Condition: Quality Assessment/Performance Improvement. 410 IAC 17-12-2(a)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure staff followed standard infection control procedures in 2 of 2 home visits with a home health aide (Patient #2, 4). The findings include: * During an observation of care at the home of Patient #2 on 3/19/2024, between 9:01 AM and 9:50 AM, HHA 2 was observed with gloved hands washing a brown substance from in between the patient’s thighs and genital area with disposable wipes, removed gloves, and applied new gloves without performing hand hygiene in between glove change. HHA 2 was observed with gloved hands washing the patient’s buttocks and in between the patient’s buttocks with a washcloth and a brown substance was visible on the washcloth, and HHA 2 was observed placing the washcloth into the soapy wash basin. HHA 2 was then observed removing the washcloth from the soapy wash basin and continuing to wash the patient’s buttocks. HHA 2 was then observed applying a barrier cream and a new brief without first removing gloves and performing hand hygiene. HHA 2 was then observed removing gloves and applying new gloves without performing hand hygiene in between glove change. On 3/20/2024, at 3:57 PM, the Clinical Manager indicated staff should wash their hands in between glove changes and change the washcloth and the water after washing the genital area and buttocks. 410 IAC 17-12-1(m) 1. A policy titled “Hand Washing”, last reviewed 9/12/2023, indicated staff should perform hand hygiene after removing gloves. The policy also indicated staff are to decontaminate hands after coming into contact with bodily fluids and secretions and after before moving from a dirty site to a clean site on the body. 2. During a home visit on 3/20/2024, HHA (home health aide) 1 was observed changing gloves 7 times while bathing Patient #4. HHA 1 failed to perform hand hygiene after removing gloves, before applying new gloves. During an interview on 3/20/2024 at 1:19 PM, the Alternate Clinical Manager (who observed the visit) indicated the HHA failed to perform hand hygiene after removing gloves, before applying new gloves.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide infection control education to staff annually for 12 of 12 skilled professional staff members (Administrative Staff 1, 2, 3; Licensed Practical Nurse 1; Physical Therapy Staff 1, 2, 3, 4, 5, 6, 7; Occupational Therapy Staff 1). The findings include: A policy titled “Infection / Exposure Control Plan”, last reviewed 9/12/2023, indicated infection control in-services shall be scheduled no less than annually, attendance shall be mandatory and documented, and records of in-service attendance shall be maintained in the personnel file. A record review failed to evidence infection control education was provided annually for the following skilled professionals: Administrative Staff 1, 2, 3; Licensed Practical Nurse 1; Physical Therapy Staff 1, 2, 3, 4, 5, 6, 7; Occupational Therapy Staff 1. During an interview on 3/22/2024, the Administrator indicated skilled nurse and therapy staff should receive infection control training annually, but she did not have record of this training.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the nurse failed to provide services only as ordered by the physician in 1 of 1 home visits of a patient with a pressure ulcer and nephrostomy tube (Patient #4). The findings include: Observation of a home visit on 3/20/2024 at 12:07 PM evidenced Patient #4 had a large dry gauze on top of a Duoderm on the sacrum. When the gauze was removed, a light-colored dressing was visible underneath the Duoderm. The Patient had a nephrostomy tube on the right side of their back. The insertion site was covered with gauze and a large Tegaderm (clear film adhesive dressing). A clinical record review for Patient #4, certification period 2/8/2024 to 4/7/2024 evidenced the following wound care for the sacral pressure ulcer: cleanse with saline, apply Silvadene (a topical antibiotic), and cover with a Duoderm (a hydrocolloid dressing) twice a week. The wound care orders failed to evidence any dressing to be placed underneath the Duoderm. The plan of care failed to evidence orders for nephrostomy site care. During an interview on 3/20/2024 at 10:06 AM, Person 2 (caregiver to Patient #4) indicated the nurse performed wound care by cleaning it, packing it, and applying a Duoderm. During an interview on 3/20/2024 at 11:17 AM, LPN 1 indicated she changed the dressing to the nephrostomy tube that morning. LPN 1 indicated they did not have orders to change the dressing or how to care for the site, but she changed it to see what was going on. When asked if the dressing to the nephrostomy site had been changed before today, LPN 1 stated, “I can’t answer that”. 410 IAC 17-14-1(a)(2)(F)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse (RN), licensed practical nurse (LPN), physical therapist (PT), and physical therapy assistant (PTA) failed to prepare notes accurately and timely in 5 of 7 clinical records reviewed. (Patient #2, 3, 4, 5, and 7) The findings include: 6. A review of the plan of care for certification period 2/28/2024 to 4/7/2024 evidenced Patient #4 was to receive 2 skilled nursing visits per week. A clinical record review on 3/19/2024 failed to evidence any completed nurse visit notes since the resumption of care on 3/4/2024. During an interview on 3/20/2024 at 10:06 AM, Person 2 (caregiver to Patient #4) indicated LPN (licensed professional nurse) 1 saw the patient twice a week and had not missed any visits since the Patient returned home from the hospital. During an interview on 3/19/2024 at 2:50 PM, the Clinical Manager indicated LPN 1 saw the Patient twice a week for wound care. When informed of the findings, the Clinical Manager indicated LPN 1 should have completed her visit notes within 48 hours, and she was aware this was a problem they were working on. 7. A review of the plan of care for certification period 1/6/2024 to 3/15/2024 evidenced Patient #5 was to receive 2 physical therapy visits per week. A clinical record review on 3/20/2024 any physical therapy revisit notes. During an interview on 3/21/2024 at 10:20 AM, Patient #5 indicated PTA (physical therapy assistant) 2 saw her twice a week. During an interview on 3/21/2024 at 11:53 AM, the Clinical Manager indicated PTA was seeing Patient #5 twice a week, but failed to document the revisit notes, and they were working on getting them entered now. 410 IAC 17-14-1(a)(1)(E) 410 IAC 17-14-1(a)(2)(B) 410 IAC 17-14-1(c)(5) 1. Review of a policy titled “Timeliness and Accuracy of Entries in the Clinical Record” dated 1/14/2021, indicated the clinicians would document accurately and complete clinical notes on the date service is provided. 2. A clinical record review for Patient #7 evidenced the visit note completed by LPN 1 dated 1/3/2024 was not created in the electronic health record until 1/13/2024. The plan of care for certification period 11/14/2023-1/12/2024 indicated the patient’s medications included, but were not limited to, apixaban (anticoagulant medication used to thin the blood to reduce clot formation) 2 times daily. The discharge comprehensive assessment completed by the Alternate Clinical Manager/RN and dated 1/12/2024 failed to indicate the patient was taking a medication in the high risk drug classification of anticoagulants. On 3/20/2024, at 11:45 AM, the Clinical Manager indicated the anticoagulant box was not checked under high risk drugs but should have been. 3. A clinical record for Patient #3 evidenced a skilled nurse visit note assigned to LPN 1 dated 3/13/2024, which indicated the note was created on 3/19/2024 in the electronic health record and was incomplete. On 3/20/2024, at 3:03 PM, the Clinical Manager indicated the visit was made by LPN 1 on 3/13/2024 and should have been completed. A PT visit note completed by PT 1 and dated 3/6/2024 was not created until 3/19/2024 in the electronic health record. PTA visit notes completed by PTA 2 and dated 2/27/2024, 3/12/2024, and 3/14/2024, indicated the PTA notified the physician and received new orders. Review failed to evidence new orders. On 3/21/2024, at 5:32 PM, PTA 2 indicated the documentation indicating the physician was notified and new orders received was a carry-over and not accurate documentation. PTA 2 indicated he/she did not call the physician and did not receive new orders. 4. A clinical record review for Patient #2 evidenced HHA supervisory visits completed by the Clinical Manager/RN conducted on 2/5/2024 and 3/5/2024 which failed to be created in the electronic health record until 3/18/2024. 5. During an interview on 3/20/2024, beginning at 12:00 PM, the Clinical Manager indicated clinicians could document the visit until the visit note was created in the electronic health record. The Clinical Manager indicated she had previously instructed staff to document at the time of the visit and indicated the visits should be created at the time of the start of care or recertification when the staff was scheduled for the ordered frequency of visits. The Clinical Manager indicated she knew the visits were created late in the electronic health record. 410 IAC 17-14-1(a)(1)(E) 410 IAC 17-14-1(a)(2)(B) 410 IAC 17-14-1(c)(5)

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the home health aide provided services only after successfully completing a competency evaluation (see tag G0768); the home health aide was assigned with appropriate written instructions (see tag G0798); the home health aide provide services that were included in the plan of care (see tag G0800); and the home health aide supervision ensured the care provided followed the plan of care (see tag G0818). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.80 Home Health Aide Services.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the home health aide (HHA) did not complete any task that they did not demonstrate competency to in 1 of 1 home health aide visit with hoyer (mechanical lift device) used. (Patient #2) The findings include: During an observation of care at the home of Patient #2 on 3/19/2024, at 9:48 AM, HHA 2 was observed transferring the patient from the bed to the wheelchair with the hoyer lift. Personnel record review for HHA 2 evidenced the skills competency completed in March 2023 and March 2024, which failed to include competency on patient transfer with a hoyer lift. On 3/21/2024, at 2:44 PM, the Clinical Manager indicated the competency checklist for HHA 2 did not include competency to the hoyer lift. 410 IAC 17-14-1(l)(A)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to assign tasks appropriately to the home health aide (HHA) in 2 of 2 active clinical records reviewed with HHA services. (Patient #2, 4) The findings include: 3. Observation of a home visit on 3/20/2024 at 12:07 PM evidenced Patient #4 was non-verbal, did not follow commands, and could not participate in care. A review of the Aide Care Plan for Patient #4, certification period 2/8/2024 to 4/7/2024, included the following tasks: assist with oral hygiene, assist with dressing every visit, and remind to take medication every visit. During an interview on 3/19/2024 at 2:57 PM, the Clinical Manager indicated the aide care plan should indicate the aide provides total care, not just assist, and does not remind the patient to take medications. 410 IAC 17-14-1(m) Based on record review and interview, the registered nurse (RN) failed to assign tasks appropriately to the home health aide (HHA) in 1 of 2 active clinical records reviewed with HHA services. (Patient #2) The findings include: 1. A review of a policy titled “Certified Nursing Aide/Home Health Aide” dated 1/14/2021, indicated the RN should assign tasks to the HHA according to the plan of care. 2. A clinical record review for Patient #2 evidenced the plan of care for certification period 2/15/2024-4/14/2024, which indicated the patient was not to have anything by mouth (NPO). The plan of care indicated the aide was to prepare a meal/snack at every visit. On 3/22/2024, at 10:45 AM, the Clinical Manager indicated the RN should not have assigned the preparation of a meal/snack to the aide. 410 IAC 17-14-1(m)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health aide (HHA) failed to provide services as directed in the plan of care in 2 of 2 active clinical records reviewed with HHA services (Patient #2 and 4). The findings include: A clinical record review for Patient #2 evidenced the plan of care for certification period 2/15/2024-4/14/2024, which indicated the HHA was to provide services 5 days a week to include a bath, perform fingernail care, and record the last bowel movement at every visit. During an observation of care on 3/19/2024, between 9:09 AM and 9:40 AM, with the Clinical Manager present, HHA 2 was observed bathing the patient in the bed to include washing a brown substance from the patient’s genital and buttock area. HHA 2 was not observed to have washed the patient from below the thighs and did not remove the patient’s socks. At 9:40 AM, HHA 2 was observed dressing the patient and a brown substance was observed on the left outer side of the thigh, which HHA 2 was not observed to have washed. HHA 2 indicated she washed the patient’s feet on Monday and was not doing so at this visit. On 3/20/2024, at 3:57 PM, the Clinical Manager indicated she saw the stool left on the patient’s leg and the aide should have washed the patient’s legs and feet since a partial bed bath was not marked on plan of care. The HHA visit notes from 2/15/2024-3/18/2024 failed to evidence the aide recorded the last bowel movement. The HHA visit notes dated 3/19/2024 and 3/20/2024 failed to evidence the HHA provided fingernail care. On 3/22/2024, at 10:45 AM, the Clinical Manager indicated all care should be provided as directed in the plan of care and indicated the last bowel movement was not recorded and the fingernail care was not completed on the notes. 2. During a observation of a home visit on 3/20/2024 at 12:07 PM, HHA (Home Health Aide)1 stopped the tube feeding pump and clamped the tube feeding prior to starting Patient #4’s bath. When cleaning the patient’s buttocks, HHA 1 removed the soiled outer dressing over the Duoderm (a hydrocolloid patch dressing) and placed a new dressing over the Duoderm. After completing the bath and elevating the head of the Patient’s bed, HHA restarted the tube feeding pump. During an interview on 3/20/2024 at 1:13 PM, HHA 1 indicated she learned to clamp, stop, and restart tube feedings at a previous job in a long term care facility, and she did not receive training on tube feedings from AAA Hoosier Home Health. HHA 1 indicated she did not know if she was supposed to change dressings, but that’s what she did to keep it clean. During an interview on 3/20/2024 at 1:19 PM, the Alternate Clinical Manager indicated the aide should not have done anything with the tube feeding or change dressings, and there was always a family member in the home who was able to manage the tube feeding.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide (HHA) was supervised to ensure the aide furnished care that followed the patient’s plan of care in 2 of 2 active clinical records reviewed with home health aide services (Patient #2, 4). The findings include: A clinical record review for Patient #2 evidenced the plan of care for certification period 2/15/2024-4/14/2024, which indicated the aide was to provide services 5 days a week and record the last bowel movement at every visit. The HHA visit notes from 2/15/2024-3/18/2024 completed by HHA 2 failed to evidence the aide recorded the last bowel movement. The HHA supervisory visit completed by the Clinical Manager and dated 3/5/2024, indicated the HHA provided care per the plan of care and failed to evidence the registered nurse provided home health aide supervision to ensure the home health aide followed the aide care plan as directed. On 3/22/2024, at 10:48 PM, the Clinical Manager indicated the aide should not have been marked as following the plan of care and indicated the agency needed to start reviewing the HHA notes as part of the supervision. 410 IAC 17-14-(n) 2. A review of the Aide Care Plan for Patient #4, certification period 2/8/2024 to 4/7/2024, indicated the aide should perform the following tasks weekly on Wednesday: shampoo hair, laundry, and change linen. The plan also indicated the aide should record the Patient’s last bowel movement in the comment section of each aide visit note. An aide visit note dated 3/4/2024 (Monday), 3/5/2024 (Tuesday), 3/7/2024 (Thursday), 3/8/2024, 3/16/2024 (Saturday), 3/17/2024 (Sunday), indicated the HHA (Home Health Aide) shampooed the patient’s hair, did laundry, and changed linen. These HHA notes as well as a note dated 3/6/2024 failed to evidence the patient's last bowel movement. During an interview on 3/19/2024 at 2:57 PM, the Clinical Manager indicated the HHA should have performed care as indicated in the Aide Care Plan, and they failed to document the last bowel movement as instructed. 410 IAC 17-14-(n)

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 administration failed to be responsible of the day-to-day operations of the agency to include ensuring agency policies were followed for timeliness of OASIS (Outcome and Assessment Information Set) transmissions to CMS (Centers for Medicare and Medicaid Services) in 4 of 4 active skilled clinical records reviewed with skilled services (Patient #1, 3, 4, 5), timeliness of clinical documentation in 4 of 5 active clinical records reviewed (Patient #2, #3, #4, #5), and obtaining physician order for continuation of home health care in 2 of 3 active clinical records reviewed with more than 1 certification period (Patient #2, 3). The findings include: 1. Review of a policy dated 1/14/2021 titled “Data Entry/Transmission of OASIS Information” indicated the agency would electronically transmit OASIS data within 30 days of the assessment date. 2. Review of a policy titled “Timeliness and Accuracy of Entries in the Clinical Record” dated 1/14/2021, indicated the entries into the clinical record would be accurate and clinicians would complete clinical notes on the date service is provided. 3. Clinical record reviews for Patient #1, Patient #3, Patient #4, and Patient #5 evidenced OASIS transmissions completed over 30 days from the date of assessment. Refer to G0372. On 3/22/2024, at 10:23 AM, the Alternate Administrator indicated she was aware of the late OASIS submissions. The Alternate Administrator indicated the agency needed to wait to transmit the OASIS until the comprehensive assessment was completed and indicated the comprehensive assessment documentation was late. 4. Clinical record reviews for Patient #2, Patient #3, Patient #4, and Patient #5 evidenced late clinical record entry. Refer to G0716 and G1024. On 3/22/2024, at 11:34 AM, the Administrator indicated the agency had hired a consulting company to assist with the OASIS transmissions and indicated the issue late transmissions was an ongoing problem. The Administrator indicated there were no additional interventions taken to correct the late transmissions. 5. Clinical record reviews for Patient #2 and Patient #3 failed to evidence physician orders for care. Refer to G0580. On 3/22/2024, at 11:33 AM, the Alternate Administrator indicated she was unsure why the plans of care were sent to the physician late and indicated it could possibly be due to errors needing correction before they could be sent. The Alternate Administrator indicated the plans of care being sent to the physicians late was an ongoing problem. 410 IAC 17-12-1(c)(1)

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to provide oversight of the referral process in 3 of 4 active clinical records reviewed with a start date after the last survey on 5/20/2022. (Patient #3, 4, 5) The findings include: A review of a policy dated 1/14/2021 titled “Comprehensive Assessment of Patients OASIS [Outcome and Assessment Information Set]” indicated the initial assessment must be performed within 48 hours of receiving the referral. A review of a policy dated 1/14/2021 titled “Referrals” indicated a referral sheet must be completed upon referral to include time and date of referral and referral source. A clinical record review for Patient #3, Patient #4, and Patient #5 failed to evidence the initial visits were completed within 48 hours of referral and failed to evidence documentation as to the reason for the delay in the initial visits. Refer to G0514. On 3/22/2024, at 2:21 PM, the Clinical Manager indicated she reviewed the referrals and the Office Manager reviewed the referral’s payor source. The Clinical Manager indicated there was no tracking system for monitoring the referral process. The Clinical Manager indicated information was only entered on the referral form if the patient was accepted since that is when the patient was entered into the electronic health record and information was not entered on the referral form for denied referrals.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a written agreement with the consulting organization was established. The findings include: Review of an agreement with Entity 7 failed to evidence a signature of agreement from the organization’s representative. On 3/21/2024, at 12:51 PM, the Administrator indicated the agreement was not signed and indicated she would look for a signed copy. On 3/22/2024, at 9:35 AM, the Office Manager indicated she had contacted Entity 7 to get a copy of the signed contract and indicated the agency’s contact at Entity 7 was no longer with the organization and further attempts would be made to obtain a signed copy of the agreement. 410 IAC 17-12-2(d)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure medications were stored according to current clinical practice for 1 of 1 agency. The findings include: Review of a policy dated 1/14/2021 titled “Medication Storage” indicated the agency will store medications in their original packaging clearly labeled. During an observation on 3/18/2024, at 9:13 AM, a refrigerator was observed in the clinical record storage room labeled “biological”. Inside of the refrigerator, 6 syringes were observed with 0.1 milliliter of clear fluid in each without a label. One of the 6 syringes had a cap that was not secured and exposed the needle. On 3/18/2024, beginning at 9:13 AM, the Clinical Manager indicated she drew the syringes up with tuberculin purified protein derivative (PPD, a solution used to test for tuberculosis, an infectious disease) and indicated one of the caps came loose from the syringe. At 4:02 PM, the Clinical Manager indicated the medications should be stored with a label.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient record included all pertinent patient information in 2 of 5 active records reviewed (Patient #1, 4). The findings include: 1. An agency policy titled “Advance Directives”, last reviewed 9/12/2023, indicated if a patient has an Advance Directive, the clinician should obtain a copy and enter it into the patient’s clinical record. If a copy cannot be obtained, the clinician should document an attempt was made to obtain the documents. 2. A review of the plan of care for certification period 3/8/2024 to 5/6/2024 indicated Patient #1 was a DNR (Do Not Resuscitate). A review of the Patient’s record failed to evidence a copy of the DNR document or that an attempt was made by the clinician to obtain one. During an interview on 3/19/2024, the Clinical Manager indicated the referral documents from Facility 1 indicated Patient #1 was a DNR, but they did not include the actual DNR document. The Clinical Manager indicated the clinical record failed to evidence a copy of the DNR or documentation of an attempt to obtain one. 3. A clinical record review on 3/20/2024 for Patient #4, start of care 2/8/2024, failed to evidence initial referral documents. During an interview on 3/22/204 at 9:35 AM, the Clinical Manager indicated the initial referral documents should be scanned and included in the “Docs” section of the patient’s chart, but they were not there. 410 IAC 17-15-1(a)(1)(7)

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 sent to the primary care practitioner within 5 days of discharge in 1 of 2 closed clinical records reviewed. (Patient #7) The findings include: A clinical record review for Patient #7 evidenced a discharge summary which indicated the patient was discharged from home care services on 1/12/2024. Review indicated the document was not faxed to the physician until 1/19/2024, which was greater than 5 days. On 3/22/2024, at 10:32 AM, the Clinical Manager indicated the discharge summary was not sent to the physician until 1/19/2024. 410 IAC 17-15-1(a)(6)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plans of care included the correct address for the home health agency in 7 of 7 clinical records reviewed (Patient #1, 2, 3, 4, 5, 6, 7) and failed to ensure the home health aide (HHA) documented notes accurately and timely in 2 of 4 clinical records reviewed with home health aide services (Patient #2, 7). The findings include: 1. Review of a policy titled “Timeliness and Accuracy of Entries in the Clinical Record” dated 1/14/2021, indicated the entries into the clinical record would be accurate and clinicians would complete clinical notes on the date service is provided. 2. A clinical record review of the most recent plans of care for Patient #1, certification period 3/8/2024-5/5/2024; Patient #2, certification period 2/15/2024-4/14/2024; Patient #3, certification period 3/8/2024-5/6/2024; Patient #4, certification period 2/8/2024-4/7/2024; Patient #5, certification period 1/16/2024-3/15/2024; Patient #6, certification period 10/13/2023-12/11/2023; Patient #7, certification period 11/14/2023-1/12/2024; failed to evidence the correct address of the home health agency. On 3/18/2024, at 3:59 PM, the Administrator indicated the agency moved locations from Crown Point, Indiana to Highland, Indiana in July 2023. 3. A clinical record review for Patient #7 evidenced the visit note for home aide visit dated 1/12/2024 was not created in the electronic health record until 1/22/2024. 4. A clinical record review for Patient #2 evidenced HHA visit notes which indicated the visit completed on 2/7/2024 was not created until 2/9/2024 and visits completed on 2/21/2024 and 2/22/2024 were not created until 2/25/2024. 5. During an interview on 3/20/2024, beginning at 12:00 PM, the Clinical Manager indicated the clinician could not document the visit until the visit note was created in the electronic health record. The Clinical Manager indicated she had previously instructed staff to document at the time of the visit and indicated the visits should be created at the time of the start of care or recertification when the staff was scheduled for the ordered frequency of visits. The Clinical Manager indicated she knew the visits were created late in the electronic health record. 410 IAC 17-15-1(a)(7)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a medication review was performed for 3 of 3 active clinical records reviewed. (#1, #2, #3) The findings include: 1. Record review of an agency policy titled “Medication Administration Record (MAR)” reviewed 1/14/2022, stated “Purpose: To establish a medication administration record … Policy: It is required that the agency provide a medication administration record (MAR) for each patient that receive medications administered directly by a licensed nurse … Procedure: … A Mar will be filled out for each patient whom receives medication administration by a staff member … to prevent and reduce the likelihood of adverse drug reactions, this agency checks the medication profile for interaction risks. Drug to drug reactions listed as potentially moderate or severe are reported to the prescribing physician prior to administration. Patients are educated on other types of adverse interactions possibilities, such as consuming alcohol while taking certain medications, or food and medication interactions … High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. High-alert medications will be identified on the medication profile and MAR ….” 2. Clinical record review on 5/20/2022, for patient #1, start of care 8/20/2021, diagnoses include but not limited to wound care, hypertension [high blood pressure], and chronic pain. Record review evidenced an agency document titled “Medication Profile” which was retrieved on 5/19/2022. This document listed the following medications were effective on 8/20/2021: Hydrocodone-Acetaminophen [opioid pain medication], Hydroxychloroquine Sulfate [medication used to treat lupus, rheumatoid arthritis, and malaria], Meloxicam [nonsteroidal anti-inflammatory medication], and Pregabalin [nerve pain medication]. This document also evidenced Gabapentin [medication used for nerve pain] which had a start date of 2/11/2022. Record review evidenced agency documents titled “Service Note” which were performed by LPN [licensed practical nurse] D on 5/4/2022, 5/6/2022, 5/9/2022, 5/11/2022, and 5/13/2022. These documents had an area subtitled “Medications Assessment” which stated, “Drug Regimen Review – List problems identified: NONE … List high risk med(s) [medications] identified: NONE ….” Record review evidenced the patient was taking opioid/narcotic medications. Review evidenced the patient was prescribed high risk medications since 8/20/2021. A medication review was conducted on 5/20/2022, via the website “https://reference.medscape.com/drug-interactionchecker”. The medication review evidenced 3 drug interactions: Gabapentin and hydrocodone, pregabalin and hydrocodone, and gabapentin and acetaminophen. Two of three interactions were moderate and indicated to monitor medications closely. Record review failed to evidence a medication review was performed by the clinician. 3. Clinical record review on 5/20/2022, for patient #2, start of care 3/4/2022, diagnoses include but not limited to type 2 diabetes, hypertension, and chronic kidney disease, evidenced an agency document titled “Service Note” and subtitled “Service Note Type … 4-Recertification (follow-up) reassessment” conducted by Registered Nurse (RN) F on 4/29/2022. This document had an area subtitled “Medication Assessment” which stated “Drug Regimen Review – List problems identified: none … List high risk med(s) identified: ….” Review of the OASIS Recertification evidenced the patient was not taking high risk medications. Review of this document failed to evidence the patient’s medication profile had any drug interactions. Record review failed to evidence a medication review was performed by the clinician. 4. Clinical record review on 5/20/2022, for patient #3, start of care 7/31/2019, diagnoses include but not limited to pain and hypertension, evidenced an agency document titled “Medication Profile” which was retrieved on 5/19/2022. This document listed the following medications were effective 7/31/2019, including but not limited to: Dexamethasone (a steroid used to treat inflammation), lovastatin (used to treat high cholesterol), clopidogrel (blood thinner that prevents platelets in the blood from forming clots), potassium chloride (potassium supplement), furosemide, magnesium oxide (magnesium supplement), and lansoprazole (medication used to treat frequent heartburn). Record review evidenced an agency document titled “Comprehensive Assessment Form” which was signed by clinical manager B on 5/13/2022. This document failed to evidence a medication review was performed at the comprehensive assessment, as stated in the agency policy. 5. During the entrance conference on 5/18/2022, at 10:28 AM, clinical manager B indicated the agency’s process for drug regiment review was conducted upon admission, at recertification, any time there is a change in current medications, and is reviewed at every visit for changes. 6. During an interview on 5/20/2022, at 3:53 PM, clinical manager B indicated in hindsight, the clinicians should perform a medication reconciliation at every visit but was being done at comprehensive assessments. 410 IAC 17-14-1(a)(1)(B)

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 home health agency failed to ensure that the plan of care included individualized information including but not limited to safety measures, disciplines/frequencies/treatments, and goals for 3 of 3 active clinical records reviewed. (#1, #2, #3) The findings include: 1. Record review of an agency policy titled “Physician Orders/ Plan of Care” reviewed 1/14/2022, stated “Purpose: To ensure that each patient’s care is under the direction of the physician … Policy: The physician establishes and reviews a plan of treatment for the patient. The plan is updated and is maintained as part of the Agency's clinical record ... Procedure: 1. The physician set up a plan of care, which includes the diagnosis, prognosis, medications, frequency and types of service, treatments, diet, goals to be accomplished, an order for each service, item of drugs and equipment to be provided by the Agency … 2. All orders on the CMS 485 will be specific to the patient condition and needs ... 11. The Agency’s professional staff will review the clinical records on a continuous basis to ensure that each POC [plan of care] is specific to the patient and that additional orders for services are present in the clinical record ….” 2. Record review of an agency policy titled “Wound Care Management” reviewed 1/14/2022, stated “Purpose: To ensure the appropriateness of wound care provided by agency staff. To provide wound assessment documentation guidelines for reimbursement … Policy: Nursing staff will obtain specific physician orders to perform wound care for Agency patients. Orders shall at a minimum contain the specific protocol, technique to be observed, supplies, frequency, duration and any adverse events to report to the physician ... Procedure: … 2. If the agency has standing wound care orders from specific physicians, these orders may be used until specific orders can be obtained ….” 3. Record review of an agency policy titled “Fall Prevention” reviewed 1/14/2022, stated “Purpose: To promote a secure and safe environment within a patient's place of residence … Policy: Falls are the second leading cause of accidental death in the United States. Seventy-five percent of these falls occur in the older adult population. One third of the older adults who fall, sustain a hip fracture and are hospitalized, die within a year. falls not only affect the quality of life of the individual but also influence the caregiver and family … Even if the fall does not result in hospitalization, fear of falling becomes a major factor. Fear leads to inactivity and loss of confidence … the agency shall protect all individuals from preventable injuries and illnesses. The agency will undertake a program of education and enforcement in safety directed at employees and patients … Procedure: 1. Perform a home safety check ….” 4. Record review of an agency policy titled “Registered Nurse” reviewed 1/14/2022, stated “Purpose: To ensure that all Registered Nurse responsibilities are clearly stated … Policy: Registered Nurse (RN). Skilled nursing services shall be provided by a registered nurse in accordance with the plan of treatment with regards to the applicable nurse practice act. Nursing care shall include, but not be limited to, the following: 1. Provide those services requiring nursing skills in accordance with the plan of treatment or the plan of care … 6. Reassessing the patient nursing care needs on an ongoing, patient specific basis and providing care which is consistent with the medical plan of treatment … 10. Teaching, supervising, and counseling the patient, family members and staff regarding nursing care and the patient's needs, including other related problems of the patient at home ….” 5. Clinical record review on 5/20/2022, for patient #1, start of care 8/20/2021, diagnoses include but not limited to wound care, hypertension [high blood pressure], and chronic pain. Record review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 2/16/2022 – 4/16/2022, and signed by the physician on 2/14/2022. This document had an area subtitled “10. Medications” indicated the patient was prescribed hydroxychloroquine sulfate (a medication commonly used to treat malaria [caused by the mosquito bites] and autoimmune diseases including but not limited to lupus and rheumatoid arthritis). An area of this document subtitled “14. DME [durable medical equipment] and Supplies” stated “Walker, Normal Saline, Silver Alginate, Kerlix, Sterile Dressings, Thermometer, Non Sterile Gloves…” This document had an area subtitled “15. Safety Measures” which stated “Home Safety Assessment, Uncluttered Pathway …” An area subtitled “18.A Functional Limitations” indicated the patient had ambulation and endurance limitations. Another area subtitled “21. Orders for Discipline and Treatments (Specify Amount/ Frequency/ Duration)” stated “SN [skilled nurse] 2WK1 [twice a week for 1 week] – effective 2/16/2022, 3WK8 [three times a week for 8 weeks] – effective 2/20/2022 – TEACH AND MONITOR DISEASE PROCESS, SURGICAL WOUND, AND MEDICATIONS …” Review of this document failed to evidence fall precautions as a safety measure. Review of this document failed to evidence specific treatments and interventions ordered by the physician. Review failed to evidence specific instructions for wound care, management of hypertension, and pain management. Review failed to evidence which medications to review with the patient. Review failed to evidence all pertinent diagnoses were listed on the plan of care. During an interview on 5/20/2022, at 1:58 PM, when queried if the patient was a fall risk, clinical manager B stated “Yes …” and indicated fall risk/fall precautions should be on the plan of care. During an interview on 5/20/2022, at 2:01 PM, when queried about the reason this patient was taking the medication hydroxychloroquine sulfate, clinical manager B indicated it might be for arthritis, but could not locate the diagnosis in the patient’s plan of care. 6. Clinical record review on 5/20/2022, for patient #2, start of care 3/4/2022, diagnoses include but not limited to type 2 diabetes, foot drop, and chronic kidney disease, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/3/2022 – 7/1/2022. This document had an area subtitled “15. Safety Measures” which stated “Guard rails in bathroom, Home Safety Assessment, Uncluttered Pathway …” An area subtitled “18.A Functional Limitations” indicated the patient had bowel/bladder, ambulation, and endurance limitations. An area subtitled “18.B Activities Permitted” indicated the patient can ambulate as tolerated with a walker or wheelchair. Another area subtitled “21. Orders for Discipline and Treatments (Specify Amount/ Frequency/ Duration)” stated “SN [skilled nurse] 1WK9 [once a week for 9 weeks] – effective 5/3/2022 – may obtain blood sugar, teach and monitor diabetes, medications, and safety … HHA [home health aide] 2WK9 [twice a week for 9 weeks – effective 5/3/2022 – assist with personal hygiene and ADLs [activities of daily living]” Review of this document failed to evidence fall precautions as a safety measure. Review of this document failed to evidence specific treatments and interventions to be performed by the SN. Review failed to evidence specific instructions to teach medications and safety. Review failed to evidence the plan of care had individualized instructions for patient teaching and safety. 7. Clinical record review on 5/20/2022, for patient #3, start of care 7/31/2019, diagnoses include but not limited to pain and hypertension, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/16/2022 – 7/14/2022. This document had an area subtitled “Medications” which stated the patient was ordered to take “… clopidogrel (Plavix) [a blood thinning medication used to prevent blood platelets from clotting] tablet 75 mg [milligrams] daily oral …” Another section subtitled “15. Safety Measures” stated “Guard rails in bathroom, Home Safety Assessment, Safety Measures: Patient Lives Alone Regular daytime …” Another area subtitled “21. Orders for Discipline and Treatments (Specify Amount/ Frequency/ Duration)” stated “HHA – PA …” An area subtitled “22. Goals/Rehabilitation Potential/Discharge Plans” stated “PA HHA 8hrs [hours]/5 x [times] weekly/ 40 hrs week M [Monday] – F [Friday] 8a [AM]-4p [PM] ….” Review of this document failed to evidence bleeding precautions as a safety measure. Review failed to evidence frequencies and durations for the skilled nurse to perform supervisory visits and comprehensive assessments. Review of the plan of care failed to evidence the type of services the HHA should perform at the home visits. Review failed to evidence goals and discharge plans on the plan of care. Review failed to evidence the plan of care was individualized to the patient’s needs. During an interview on 5/20/2022, at 1:48 PM, clinical manager B indicated medication reviews for HHA only cases were performed monthly by the clinician performing the supervisory visits. During an interview on 5/20/2022, at 2:24 PM, clinical manager B indicated a SN performed skilled assessments monthly. They indicated the HHA supervisory visits were conducted monthly, and recertification assessments were performed every 60 days. 8. During an interview on 5/20/2022, at 1:44 PM, clinical manager B stated “The 485” was what a skilled nurse used to identify interventions and treatments that need to be completed at each visit. 9. During an interview on 5/20/2022, at 1:46 PM, clinical manager B indicated high-risk medications included but were not limited to blood thinner and anticoagulants, narcotics, cardiac medications, anti-diabetics and insulin. 10. During an interview on 5/20/2022, at 1:56 PM, clinical manager B indicated the diseases the SN should teach and monitor should be more specific than what was listed on the plan of care. Clinical manager B stated “Right now, the disease teaching is for the primary diagnosis.” 410 IAC 17-13-1(a)(1)(D)(i-xiii)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the skilled nurse prepared clinical records accurately and submitted timely for 2 of 2 active clinical records reviewed where a home visit was conducted. (#1, #2) The findings include: 1. Record review of an agency policy titled “Registered Nurse” reviewed 1/14/2022, stated “Purpose: To ensure that all Registered Nurse responsibilities are clearly stated … Policy: Registered Nurse (RN). Skilled nursing services shall be provided by a registered nurse in accordance with the plan of treatment with regards to the applicable nurse practice act. Nursing care shall include, but not be limited to, the following: 1. Provide those services requiring nursing skills in accordance with the plan of treatment or the plan of care. 2. The Promotion, maintenance, and restoration of health … 6. Reassessing the patient nursing care needs on an ongoing, patient specific basis and providing care which is consistent with the medical plan of treatment … 9. Prepare Documentation and clinical notes. 10. Teaching, supervising, and counseling the patient, family members and staff regarding nursing care and the patient's needs, including other related problems of the patient at home ….” 2. Record review of an agency policy titled “Licensed Practical Nurse (LPN)” reviewed on 1/14/2022, stated “Purpose: To ensure that all Licensed Practical Nurse responsibilities are clearly stated … Procedure: … 2. The LPN shall report changes in the patient’s condition to the registered nurse, and these reports shall be documented in the clinical notes … 3. The LPN shall prepare clinical notes for the clinical record and incorporate them into the clinical record at least weekly ….” 3. Record review of an agency document titled “Medication Profile” reviewed on 1/14/2022, stated “Purpose: To list and notify physician of medications that the patient is routinely taking [or] on a PRN [as needed] basis … Policy: It is the responsibility of the admitting therapist /nurse to record all medications that the patient is currently taking on a routine or PRN basis … Procedure: … nursing staff check all medications a patient may be taking to identify possible effectiveness, in effectiveness, side effects, toxic effects, desired effects, allergic reactions, unusual/ unexpected effects, actual or potential drug interactions, duplicate drug therapy, non-adherence, the need for laboratory monitoring of drug levels, drug allergies, in contraindicated medication and promptly report any problems to the physician … High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error … High-alert medications will be identified on the medication profile and MAR [medication administration record] ... The physician is notified promptly regarding any medication discrepancies, side effects, problems or reactions ….” 4. An observation of a home visit was conducted on 5/19/2022, from 9:35 AM – 10:30 AM, for patient #2, start of care 3/4/2022, with clinical manager B. During the visit, clinical manager B inquired if there were any medication changes since the last visit, patient #2 stated “No.” After clinical manager B assessed the patient, she requested the patient’s pill box. The patient’s caregiver indicated there was a new medication to take on dialysis days. The medication review in the home revealed the patient was taking a different medication for diabetes (Onglyza instead of Tradjenta), and was prescribed a new medication (Cinacalcet HCL) to take on dialysis days. During the medication review with clinical manager B and the patient’s caregiver, patient #2 indicated they had not taken all their medications in about a month. Observation of the medication review evidenced the patient had multiple empty medications including but not limited to gabapentin (medication used to treat nerve pain), carvedilol (medication used to treat high blood pressure and heart failure), furosemide (medication used to treat fluid retention often caused by heart failure and/or kidney failure), simvastatin (medication used to treat high cholesterol), aspirin (mild pain reliever with anti-platelet properties), and doxazosin (medication used to treat urinary problems and/or high blood pressure). The patient was waiting for their next doctor appointment to refill medications, which was scheduled for June 10, 2022. Clinical record review on 5/20/2022, for patient #2, diagnoses including but not limited to type 2 diabetes, congestive heart failure (chronic condition where the heart does not pump or fill adequately), end stage renal disease (when the kidneys cease to function), evidenced an agency document titled “Service Note” and subtitled “Service Note Type … 4-Recertification (follow-up) reassessment” conducted by Registered Nurse (RN) F on 4/29/2022. This document had an area subtitled “Medication Assessment” which stated “Drug Regimen Review – List problems identified: none … List high risk med(s) identified: ….” Review of this document evidenced the patient’s medications were reviewed without interactions or high-risk medication issues. Review evidenced RN F electronically signed this document on 5/19/2022, 20 days after the visit was conducted. Record review evidenced an agency document titled “Service Note” which was performed by LPN D, on 5/3/2022. This document had an area subtitled “Medications Assessment” which stated, “Drug Regimen Review – List problems identified: NONE … List high risk med(s) identified: NONE ….” This document evidenced a medication review was performed without interactions or high-risk medication issues. Review evidenced LPN D electronically signed this document on 5/18/2022, 15 days after the visit was conducted. Record review evidenced an agency document titled “Service Note” which was performed by LPN D, on 5/9/2022. This document had an area subtitled “Medications Assessment” which stated, “Drug Regimen Review – List problems identified: NONE … List high risk med(s) identified: NONE ….” This document evidenced a medication review was performed without interactions or high-risk medication issues. Review evidenced LPN D electronically signed this document on 5/19/2022, 10 days after the visit was conducted. Record review failed to evidence the skilled professionals authenticated and incorporated documentation into the clinical record weekly as stated on the agency’s policy. Record review failed to evidence medication changes since the recertification. Record review failed to evidence the medication reviews were conducted as the skilled professionals documented on the clinical notes. 5. Clinical record review on 5/20/2022, for patient #1, start of care 8/20/2021, diagnoses include but not limited to wound care, hypertension (high blood pressure), and chronic pain. Record review evidenced agency documents titled “Service Note” which were performed by LPN D on 5/4/2022, 5/6/2022, 5/9/2022, and 5/11/2022. These documents had an area subtitled “Medications Assessment” which stated, “Drug Regimen Review – List problems identified: NONE … List high risk med(s) identified: NONE ….” Record review evidenced the patient was taking opioid/narcotic medications. The bottom of this document stated, “Electronically signed and dated by: ….” which remained blank at the time the documents were retrieved on 5/19/2022 (a range of 8 to 15 days after the visits were completed). Review evidenced the patient was prescribed high risk medications since 8/20/2021. Record review failed to evidence the medication review was accurate at the time of the visit. Record review failed to evidence the documents were authenticated and incorporated into the clinical record weekly, as stated on the agency’s policy. 6. During an interview on 5/20/2022, at 1:45 PM, clinical manager B indicated a clinician should sign a visit note the day they have completed documentation. 7. During an interview on 5/20/2022, at 1:46 PM, clinical manager B indicated high-risk medications included but were not limited to blood thinner/anticoagulants, narcotics, cardiac medications, anti-diabetics and insulin. 410 IAC 17-14-1(a)(1)(E)-RN 410 IAC 17-14-1(a)(2)(B)-LPN

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with : 42 CFR 484.102. Survey Dates: 4/4/2022 to 4/8/2022 Census: 41 At this Emergency Preparedness survey, AAA Hoosier Home Health Care Specialists was found to be in compliance with Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers, 42 CFR 484.102

This visit was for a Federal Recertification and State Re-licensure Survey of a Home Health provider in conjunction with a complaint investigation. Facility ID: IN010607 Complaint #31939: Substantiated, with unrelated findings. Survey Dates: 4/4/2022 to 4/8/2022 Census: 41 These deficiencies reflect State Findings cited in accordance with 410 IAC 17. See State Form for additional findings. During this Federal Recertification Survey, AAA Hoosier Home Health Care Specialists Inc. was found to be out of compliance with Conditions of Participation 484.70 Infection prevention and control. Based on the Condition-level deficiencies during the 4/8/2022 survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 4/7/2022. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 4/8/2022 and continuing through 4/7/2024.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure OASIS data entered accurately reflected the patient's status in 2 of 4 records reviewed receiving wound care (#3, #7). The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Comprehensive Assessment of Patients (OASIS) [Outcomes and Assessment Information Set -- the patient-specific, standardized assessment used in Medicare home health care]", dated 1/14/2021, which stated, " ... The OASIS data collected must accurately reflect the patient's status at the time of the assessment...." 2. Clinical record review on 4/6/2022, for patient #3, start of care 8/20/2021, certification period 2/16/2022 to 4/16/2022, primary diagnosis of Disruption of external operation wound, evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", signed by RN [registered nurse] C on 2/11/2022. This plan of care had a subsection titled, "Goals / Rehabilitation Potential / Discharge Plans", which stated, " ... PATIENT NEEDS ASSISTANCE WITH PERSONAL HYGIENE AND ADLS [activities of daily living] ... UNABLE TO SAFELY CLIMG [sic] STAIRS, AMBULATE [walk], AND PERFORM ADLS...." Clinical record review evidenced an agency document titled, "Service Note ... Recertification (follow-up) reassessment ... Outcome and Assessment Information Set.....", dated 2/11/2022, and signed by RN [registered nurse] C. This assessment had a subsection titled, "GG: FUNCTIONAL ABILITIES & GOALS". This assessment indicated the patient was independent in the following activities: Eating, Oral Hygiene, Toileting Hygiene, Roll left and right, Sit to lying, Lying to sitting on side of bed, Sit to stand, Chair / bed-to-chair transfer, Toilet transfer, Walk 10 feet. This assessment indicated the patient required only setup or clean-up assistance for the following activities: Walk 50 feet with two turns, Walking 10 feet on uneven surfaces, Going up and down one step, and Going up and down four steps with or without a rail. During an interview on 4/8/2022, at 3:07 p.m., the clinical supervisor indicated the OASIS should accurately reflect the patient's status at the time of the assessment. When informed of the findings, the clinical supervisor indicated the plan of care was accurate, and the OASIS functional abilities assessment failed to evidence the patient's current assessment. 3. Clinical record review for patient #7 on 4/7/2022, start of care 5/6/2021, certification period 1/1/2022 to 3/1/2022, primary diagnosis of Non-pressure chronic ulcer of right foot, evidenced an agency document titled, "Service Note ... Recertification (follow-up) reassessment...." dated 12/31/2021, and signed by the clinical supervisor. Clinical record review evidenced a group of agency documents titled, "Service Note ... SN [skilled nurse] Routine Visit", dated 1/3/2022, 1/5/2022, 1/7/2022, 1/10/2022, 1/12/2022, 1/14/2022, 1/17/2022, 1/19/2022, 1/21/2022, 1/24/2022, and 1/26/2022, signed by LPN (licensed practical nurse) I. Each of the nurse's notes evidenced a subsection titled, "Integumentary Assessment", which stated, " ... Type of Wound: Venous Stasis ... Location of Wound: R [right] FOOT...." Clinical record review evidenced an agency document titled, "Outcome and Assessment Information Set", identified by the clinical supervisor as the discharge OASIS for patient #7, dated 2/11/2022, which stated, " ... Does this patient have a Stasis Ulcer?" The box indicating "No" was marked with a check-mark. The assessment failed to evidence the patient had any wounds. During an interview on 4/8/2022, at 3:50 p.m., the clinical supervisor indicated the patient had a wound when discharged. When queried, the clinical supervisor indicated the discharge OASIS failed to evidence the patient's wound. The clinical supervisor indicated the wound was not documented on the discharge OASIS because patient's wound did not fit into any of the options listed in the assessment. When informed the same wound had been documented as a venous stasis ulcer on previous assessments, the clinical supervisor offered no further information.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all physician orders were recorded in the plan of care in 2 of 4 records reviewed receiving wound care (#3, #6). The findings include: 1. Record review on 4/8/2022 evidenced an agency policy titled, "Physician Orders / Plan of Care", dated 1/14/2021, which stated, " ... The physician establishes and reviews a plan of treatment for the patient. The plan is updated and is maintained as part of the Agency's clinical record ... The Agency's professional staff will review the clinical records on a continuous basis to ensure that each POC [plan of care] is specific to the patient and that additional orders for services are present in the clinical record...." 2. Clinical record review on 4/6/2022, for patient #3, start of care 8/20/2021, certification period 2/16/2022 to 4/16/2022, primary diagnosis of Disruption of external operation wound, evidenced an agency document titled, "PHYSICIAN'S ORDER", dated 2/28/2022, which stated, "HHA [home health aide] 2WK7 [twice a week for 7 weeks] - effective 2/28/2022. Clinical record review evidenced a group of agency documents titled, "Service Note", signed by HHA F, dated 3/3/2022, 3/8/2022, 3/10/2022, 3/17/2022, 3/22/2022, 3/24/2022, 3/29/2022, and 3/31/2022. Clinical record review evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", signed by the physician on 2/14/2022. The plan of care had a subsection titled, "Orders for Discipline and Treatments....", which stated, " ... SN [skilled nursing] 2WK1 [twice a week for one week] - effective 2/16/2022, 3WK8 [three times a week for 8 weeks] - effective 2/20/2022...." The plan of care failed to evidence home health aide services. During an interview on 4/8/2022, at 2:53 p.m., the clinical supervisor indicated the plan of care should contain all orders for treatment and that the plan of care should be updated with any changes. When informed of the findings, the clinical supervisor indicated the plan of care needed to be updated with the physician's order for HHA services. 3. Clinical record review on 4/7/2022, for patient #6, start of care 7/30/2021, certification period 7/30/2021 to 9/27/2021, primary diagnosis of Pressure ulcer right buttock, stage 4 (a bedsore that extends to the muscle or bone), evidenced a document titled, "Visit Discharge Instruction Details", from wound clinic D, dated 8/5/2021, signed by physician E. The document had a subsection titled, "Other Orders", which stated, " ... RX [prescription] given: Lidocaine [a numbing medication] patch 5% 3 daily disp [dispense] 60 ... Lotrisone [an anti-fungal medication] cream apply twice a day as a barrier cream 90 gm [gram] ... Zinc Oxide [a topical treatment for irritated skin] 2% apply to excoriated [scraped or abraded skin] area 50 gm .... Nizoral [an anti-fungal medication] 200 mg [milligram] 1 by mouth daily ... Atarax [an antihistamine] 25 mg p.o. [by mouth] 3 times a day for itching...." Clinical record review evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", signed by the physician on 8/8/2021. The plan of care had a subsection titled, "Medications". Review of the medication list failed to evidence Lidocaine, Lotrisone, Zinc Oxide, Nizoral, and Atarax. Clinical record review evidenced an agency document titled, "Medication Profile", dated 9/1/2021. Review of the medication profile failed to evidence Lidocaine, Lotrisone, Zinc Oxide, Nizoral, and Atarax. During an interview on 4/4/2022, at 10:24 a.m., the clinical supervisor indicated if a patient receives a new medication, the nurse should get an order for the medication, then add it to the patient's medication profile and plan of care.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide treatments only as ordered by the physician in 2 of 3 records reviewed receiving physical therapy (#2, #5). The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Physician Orders / Plan of Care", dated 1/14/2021, which stated, " ... Purpose: To ensure that each patient's care is under the direction of the physician ... Procedure: 1. The physician sets up a plan of care, which includes ... frequency and type of service, treatments...." 2. Record review evidenced an agency policy titled, "Registered Nurse", dated 1/14/2021, which stated, " ... Skilled nursing services shall be provided by a registered nurse in accordance with the plan of treatment...." 3. Observation of a home visit for patient #2 was conducted on 4/5/2022, at 11:04 a.m. At 11:23 a.m., RN (registered nurse) C was observed using the patient's equipment to check the patient's blood sugar. Clinical record review on 4/5/2022, for patient #2, start of care 3/30/2021, certification period 3/25/2022 to 5/23/2022, primary diagnosis of Pneumonia, evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE". Review of the plan of care failed to evidence checking the patient's blood sugar. Clinical record review evidenced an agency document titled, "CARE NEEDS", identified by the clinical supervisor as part of the patient's plan of care, signed by RN C on 3/27/2022. Review of the care needs failed to evidence checking the patient's blood sugar. During an interview on 4/18/2022, at 12:05 p.m., the clinical supervisor indicated care should be provided as indicated in the patient's plan of care, which included the "Home Health Certification and Plan of Care" and the "Care Needs". When informed of the findings, the clinical supervisor indicated she did not believe any of the agency's diabetic patients had orders for the nurse to check their blood sugar, it was something they (nurses) just knew to do. 4. Clinical record review on 4/7/2022, for patient #5, start of care 3/16/2022, certification period 3/16/2022 to 5/14/2022, primary diagnosis of Unspecified open wound, evidenced an agency document titled, "PHYSICIAN'S ORDER", dated 3/23/2022, which stated, " ... Cleanse wound to R [right] foot 2nd and 3rd amputation site with normal saline, apply Opticell AG [a wound dressing with silver], cover with ABD [absorbent dry gauze] and Kerlix [rolled gauze] 2 x weekly [two times weekly]. Patient / family may perform wound care if dressing becomes soiled or falls off...." Clinical record review evidenced a group of agency documents titled, "Service Note", signed by RN [registered nurse] H. Notes dated 3/19/2022 and 3/21/2022 had a subsection titled, "Integumentary [skin] Assessment", which stated, " ... Cleansed with: saline Filled with: wet to dry Covered with: medical tape Performed by: Nurse....". During an interview on 4/8/2022, at 2:27 p.m., the clinical supervisor indicated the nurse failed to perform wound care as ordered by the physician on 3/19/2022 and 3/21/2022. The clinical supervisor indicated the Opticell may not have been available yet, and stated, "If they didn't have it, the proper protocol would be to get an order". 410 IAC 17-13-1(a)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to coordinate care with other entities providing services in 2 of 3 records reviewed with a home visit conducted (#1, #2). The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Coordination of Patient Care", dated 1/14/2021, which stated, " ... Purpose: To ensure that all staff and agencies providing services to a patient are engaged in effective interchange, reporting, and coordination of care regarding the patient. Ensure that documentation in the patient's clinical record shows coordination of services. Policy: All service providers involved in the care of a patient, including contracted health care professionals or another Agency, will be engaged in an effective interchange, reporting and coordination of care regarding the patient. All such coordination of care will be documented in the patient record...." 2. Record review evidenced an agency policy titled, "Patient Records", dated 1/14/2021, which stated, " ... Procedure: ... The patient record will include but not be limited to all of the following information: ... jj. Documentation of coordination of care between disciplines, as well as other providers...." 3. Observation of HHA (home health aide) E's visit for patient #1 was conducted on 4/5/2022, at 8:55 a.m. Person B, employee of home care agency A, was observed cleaning the patient's kitchen. Clinical record review on 4/5/2022, for patient #1, start of care 7/27/2021, certification period 3/24/2022 to 5/22/2022, primary diagnosis of Heart failure, failed to evidence any coordination of care with home care agency A. During an interview on 4/5/2022, at 8:59 a.m., person B indicated the duties they performed for patient #1 were preparing food, general cleaning, and laundry. Person B indicated they and HHA E both cleaned the patient's home. During an interview on 4/5/2022, at 9:03 a.m., HHA E indicated they would make the patient's bed and clean the patient's living space if not already done by Person B. During an interview on 4/8/2022, at 2:10 p.m., the clinical supervisor indicated if care was being provided to a patient by another agency, they would coordinate care with that agency by phone. The clinical supervisor indicated if that communication was documented in the patient's record, it should be in the visit notes or coordination notes. When informed of the findings, the clinical supervisor offered no further information or documentation. 4. Clinical record review on 4/5/2022, for patient #2, start of care 3/30/2021, certification period 3/25/2021 to 5/23/2021, primary diagnosis of Pneumonia, evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", signed by the physician on 3/29/2022. The plan of care had a subsection titled, "Goals / Rehabilitation Potential / Discharge Plans", which stated, " ... DAILYSIS [sic] ACCESS TO LEFT ARM HAS BRUILLS [sic] THRILLS [a a palpable vibration of blood flow through a dialysis fistula] AT THIS TIME...." The plan of care had a subsection titled, "POC [plan of care] collaboration", which failed to evidence coordination of care with the dialysis center. Clinical record review of all visit notes and coordination notes failed to evidence coordination of care with the dialysis center. During an interview on 4/5/2022, at 11:45 a.m., RN (registered nurse) C indicated patient #2 went to dialysis center C every Monday, Wednesday, and Friday. When queried, RN C indicated dialysis center C would communicate with the agency by sending patient information via fax if the agency requested it. During an interview on 4/8/2022, at 2:10 p.m., the clinical supervisor indicated if care was being provided to a patient by another agency, they would coordinate care with that agency by phone. The clinical supervisor indicated if that communication was documented in the patient's record, it should be in the visit notes or coordination notes. When informed of the findings, the clinical supervisor offered no further information or documentation. 410 IAC 17-12-2(h)

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure patients were provided with a current medication list in 3 of 3 home visits conducted (#1, #2, #3). The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Medication Profile", dated 1/14/2021, which stated, " ... Policy: It is the responsibility of the admitting therapist / nurse to record all medications that the patient is currently taking on a routine or PRN [as needed] basis. Documentation will include upon admission, the medication, route, amount and frequency...." 2. Observation of a home visit for patient #1 was conducted on 4/5/2022, at 8:55 a.m. At 9:35 a.m., review of the agency folder failed to evidence a current patient medication list. RN (registered nurse) C reviewed the agency folder, and indicated it failed to evidence a current patient medication list. 3. Observation of a home visit for patient #2 was conducted on 4/5/2022, at 11:04 a.m. At 11:13 a.m., review of the agency folder failed to evidence a current patient medication list. 4. Observation of a home visit for patient #3 was conducted on 4/6/2022, at 10:50 a.m. At 10:58 a.m., review of the agency folder failed to evidence a current patient medication list. 5. During an interview on 4/6/2022, at 4:03 p.m., office manager D indicated they printed out medication profiles for each patient for the staff to put in the agency folder in each patient's home. When informed of the findings, office manager D and the administrator offered no further information.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all employees practiced standard/universal precautions to prevent the transmission of infections (see tag G0682), and maintain a program for identification, prevention, control and investigation of infectious and communicable diseases (see tag G0684). This has the potential to affect all patients who received services within the agency. The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.70 Infection Control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all employees practiced standard/universal precautions to prevent the transmission of infections in 2 of 3 home visits (#1, #2) The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Contaminated Reusable Materials Disposition", dated 1/14/2021, which stated, " ... C. Equipment: 1. Cleaning reusable equipment that may come in contact with mucous membranes or body fluids. (This refers to equipment that personnel transport from patient to patient in the performance of their duties (i.e., BP [blood pressure] cuffs, stethoscope, thermometers, scales, ultrasound). a) Wipe patient exposed portions of equipment with 1:10 bleach solution or other appropriate cleaning solution. b. Return equipment to carrying case...." 2. Record review evidenced an agency policy titled, "Therapy Bag Technique", dated 1/14/2021, which stated, " ... Objective: To prevent contamination of reusable equipment carried by home health personnel from patient to patient ... Principles of Bag Technique: 1. The inside of the bag is considered clean. Never put soiled articles in the bag ... The bag should not be placed on the floor ... Reusable equipment (BP cuffs, stethoscope, etc.) are kept in zip lock baggies inside the bag. The outside of the zip lock baggie is considered clean...." 3. Observation of a home visit for patient #1 was conducted on 4/5/2022, at 8:55 a.m. At 8:58 a.m., RN (registered nurse) C was observed placing their bag on a barrier on the floor, near the patient's feet. At 9:05 a.m., RN C was observed cleaning hands and applying gloves. At 9:13 a.m., RN C was observed taking a zip lock bag out of the tote bag, removing a thermometer from the zip lock, placing it on the patient's forehead, and returning the thermometer to the zip lock bag. RN C failed to clean the thermometer before returning it to the zip lock bag. RN C then removed a pulse oximeter out of the same zip lock bag, used it on the patient's finger, then placed the pulse oximeter and empty zip lock bag on the barrier on the floor. At 9:14 a.m., RN C was observed reaching into the tote bag and removing a second zip lock bag containing a blood pressure cuff. RN C failed to change gloves and perform hand hygiene before entering the nurse's bag. RN C then placed the blood pressure cuff on the patient's left arm, checked the patient's blood pressure, removed the cuff, and placed it on the barrier on the floor. While RN C was assessing the patient, the patient was observed moving their legs, causing their bare feet to go onto the barrier, and rub on the bags. At 9:17 a.m., RN C was observed cleaning the blood pressure cuff, returning it to the zip lock bag it was in, and placing the zip lock in the nurse's bag. RN C then cleaned the pulse oximeter, put it in the zip lock bag with the used thermometer, then took the thermometer out, cleaned it, and returned it to the same zip lock bag. RN C then placed that zip lock in the nurse's bag. RN C failed to clean the bags touched by the patient's feet. 4. Observation of a home visit for patient #2 was conducted on 4/5/2022, at 11:04 a.m. At 11:13 a.m., RN C was observed removing a zip lock bag from their nurse's bag, while wearing gloves, and removing a thermometer from the bag. RN C then placed the thermometer on the patient's forehead and returned it to the zip lock bag. RN C failed to clean the thermometer before placing it in the bag. RN C then placed the zip lock on top of the opened nurse's bag, and removed a second zip lock bag, containing a blood pressure cuff. RN C failed to change gloves and perform hand hygiene before entering the nurse's bag. 5. During an interview on 4/5/2022, at 1:45 p.m., the clinical supervisor indicated all staff should follow the infection control policy regarding hand hygiene, cleaning equipment, and bag technique. When informed of the findings, the clinical supervisor offered no further information. 410 IAC 17-12-1(m)

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain a program for identification, prevention, control and investigation of infectious and communicable diseases. The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Infection / Exposure Control Plan", dated 1/14/2021, which stated, " ... The home care Agency will design, measure, assess and improve the function of surveillance, prevention and control of infections monthly through its Performance Improvement Plan ... The intent of the Infection / Exposure Control Plan is to ... Provide for surveillance systems to track the occurrence and transmission of infections...." 2. Record review evidenced an agency policy titled, "Evaluating and Maintaining Records of Infections Among Patients", dated 1/14/2021, which stated, " ... All patient and employees with a suspected infection will be added to the Infection Control Log within twenty-four (24) hours of discovery ... The patient or employee should be added to the monthly "Infection Control Log" when the following occurs: 1. A new, actual or suspected infection is clinically observed by home care personnel. 2. A culture is ordered and performed; include the organism diagnosed. 3. A new antibiotic is ordered ... The Clinical Manager summarizes trends and analyzes the Employee and the Patient Infection Control Logs monthly ... The Clinical Manager in conjunction with the Program Managers, investigate causal factors and recommends appropriate action to contain the transmission of the infection ... Information from the summary, analysis, and discussion is used to improve patient / patient care...." 3. Clinical record review on 4/5/2022, for patient #2, start of care 3/30/2021, certification period 3/25/2022 to 5/23/2022, primary diagnosis of Pneumonia, evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE". The plan of care had a subsection titled, "Goals / Rehabilitation Potential / Discharge Plans", which stated, " ... 60 Day Summary (1/24/2022 - 3/24/2022 ) ... HAS ABTS [antibiotics] FOR 5 DAYS AZITHROMYCIN [antibiotic] 250MG [milligram] FOR TREATMENT OF PNEUMONIA...." Review on 4/7/2022, at 3:56 p.m. of what was identified by the clinical supervisor as the agency's complete Infection Log for 2020 to present, failed to evidence any entries for patient #2. 4. Clinical record review on 4/7/2022, for patient #5, start of care 3/16/2022, certification period 3/16/2022 to 5/14/2022, primary diagnosis of Unspecified open wound, evidenced an agency document titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE". The plan of care had a subsection titled, "Medications", which stated, " ... Cephalexin [an antibiotic] 500 mg [milligram] 1 cap 4 x daily [four times daily] x 14 days [for fourteen days] by mouth...." Clinical record review evidenced a document titled, "H&P [history and physical] Addendum", signed by physician F on 3/14/2022. The document stated, " ... Patient presents with Wound Infection ... Assessment & Plan Principal Problem: Infected wound...." Review on 4/7/2022, at 3:56 p.m. of what was identified by the clinical supervisor as the agency's complete Infection Log for 2020 to present, failed to evidence any entries for patient #5. 5. Review on 4/7/2022, at 3:56 p.m. of what was identified by the clinical supervisor as the agency's complete Infection Log for 2020 to present, evidenced a document titled, "Patient Infection Control Log". Review of the Infection Log failed to evidence any dated entries after 9/11/2020. Record review evidenced a second page of the Infection Log with 4 undated, incomplete entries. Review of the agency's infection control binder evidenced a document titled, "Infection Surveillance Sheet". Record review failed to evidence any infection surveillance sheets dated after 12/31/2020. 6. During an interview on 4/8/2022, at 12:21 p.m., the clinical supervisor indicated all patients who develop an infection should be included in the Infection Log. The clinical supervisor indicated if a patient has a known infection at the start of care, they should be included in the Infection Log if they are on antibiotics. When informed of the findings, the clinical supervisor indicated the Infection Log was not kept current, and failed to include patients #2 and #5. The clinical supervisor indicated the "Patient Infection Control Log" sheets should include the basic information about each patient infection, and the "Infection Surveillance Sheet" should be completed to include detailed information about the patient infection and treatment. When informed of the findings, the clinical supervisor indicated the agency had "gotten away" from using the surveillance forms.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure their COVID-19 vaccine policy evidenced contingency plans for staff who were not fully vaccinated for COVID-19. The findings include: Record review on 4/7/2022, evidenced an agency policy titled, "AAA Hoosier Home Healthcare Specialists Mandatory Vaccination Policy", revised on 4/6/2022, which stated, " ... All employees covered by this policy are required to be fully vaccinated as a term and condition of employment at AAA Hoosier Home Healthcare Specialists ... Employees not in compliance with this policy will be subject to discipline...." Review of the policy failed to evidence actions the HHA would take when staff will not get vaccinated and do not qualify for an exemption. Record review on 4/5/2022, evidenced an undated document, identified by the administrator as the tracking for employee COVID vaccinations. Review of the document evidenced HHA (home health aide) J and HHA L received one vaccination. Review of the document evidenced HHA K had not received any COVID vaccine. Review of HHA J's employee record evidenced they received one dose of a two-dose vaccine on 1/7/2021. Review of HHA L's employee record evidenced they received one dose of a two-dose vaccine on 11/18/2021. Review of HHA K's employee record failed to evidence any COVID vaccine. During an interview on 4/7/2022, at 3:38 p.m., the administrator indicated HHA J, HHA L, and HHA K were not in compliance with the vaccination mandate, and were not currently seeing patients. The administrator indicated she informed the employees, "they need to take action", but there was no set deadline or plan.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide provided care as ordered in 4 of 4 records reviewed receiving home health aide services (#1, #3, #4, #6). The findings include: 1. Record review on 4/8/2022, evidenced an agency policy titled, "Patient Records", dated 1/14/2021, which stated, " ... Procedure: ... The patient record will include but not be limited to all of the following information: ... u. Complete documentation of all known services, observations, and significant events, as well as reports sent to the physician...." 2. Record review evidenced an agency policy titled, "Certified Nursing Aide / Home Health Aide", dated 1/14/2021, which stated, " ... Responsibilities: The certified nursing aide / home health aide shall have the following responsibilities: a. Provide only those services as written in the plan of care and received as written instructions from the registered nurse supervisor as permitted under State Law ... e. Perform and record accurate measurements (i.e. vital signs, or intake / output as instructed in the care plans)...." 3. Clinical record review on 4/5/2022, for patient #1, start of care 7/27/2021, certification period 3/24/2022 to 5/22/2022, primary diagnosis of Heart failure, evidenced an agency document titled, "AIDE CARE PLAN", signed on 3/24/2022, by the clinical supervisor. The care plan had a subsection titled, "Intervention", which stated, " ... Pulse every visit. Notify SN [skilled nurse] if above 100 or below 60 ... Temperature (Oral) every visit. Notify SN if above 100 or below 96 ... Respirations every visit. Notify SN if above 22 or below 12 ... Record Bowel Movement every visit...." Clinical record review evidenced documents titled, "Service Note", dated 3/29/2022 and 3/31/2022, and signed by HHA [home health aide] E. Review of the HHA notes failed to evidence a patient pulse, temperature, respiratory rate, and date of last bowel movement. During an interview on 4/8/2022, at 2:23 p.m., the clinical supervisor indicated the HHA should check each patient's temperature, pulse, and respiratory rate at each visit and document them in the visit notes. The clinical supervisor indicated the date of each patient's last bowel movement should be documented in each HHA visit note. 4. Clinical record review on 4/6/2022, for patient #3, start of care 8/20/2021, certification period 2/16/2022 to 4/16/2022, primary diagnosis of Disruption of external operation wound, evidenced an agency document titled, "AIDE CARE PLAN", signed on 2/28/2022 by the clinical supervisor. The care plan had a subsection titled, "Intervention", which stated, " ... Temperature (Oral) every visit. Notify SN if above 100 or below 96 ... Respirations every visit. Notify SN if above 22 or below 12 ... Pulse every visit. Notify SN [skilled nurse] if above 100 or below 60 ... Record Bowel Movement every visit...." Clinical record review evidenced documents titled, "Service Note", dated 3/3/2022, 3/8/2022, 3/10/2022, 3/17/2022, 3/22/2022, 3/24/2022, 3/29/2022, and 3/31/2022, and signed by HHA [home health aide] F. Review of the HHA notes failed to evidence a patient pulse, temperature, respiratory rate, and date of last bowel movement. During an interview on 4/8/2022, at 2:23 p.m., the clinical supervisor indicated the HHA should check each patient's temperature, pulse, and respiratory rate at each visit and document them in the visit notes. The clinical supervisor indicated the date of each patient's last bowel movement should be documented in each HHA visit note. 5. Clinical record review on 4/7/2022, for patient #4, start of care 7/3/2019, certification period 2/17/2022 to 4/17/2022, primary diagnosis of Multiple Sclerosis, evidenced an agency document titled, "CARE NEEDS", signed on 2/15/2022 by RN (registered nurse) C, which stated, " ... Home Health Aide Care Plan ... Intervention ... Record Bowel Movement every visit...." Clinical record review evidenced documents titled, "Service Note", dated 2/17/2022, 2/18/2022, 2/21/2022, 2/22/2022, 2/23/2022, 2/24/2022, 2/25/2022, 2/28/2022, 3/1/2022, 3/2/2022, 3/7/2022, 3/3/2022, 3/8/2022, 3/9/2022, 3/10/2022, 3/11/2022, 3/14/2022, 3/15/2022, 3/16/2022, 3/17/2022, 3/18/2022, 3/21/2022, 3/22/2022, 3/23/2022, 3/24/2022, 3/25/2022, 3/28/2022, 3/29/2022, 3/30/2022, 3/31/2022, 4/1/2022, 4/4/2022, 4/5/2022, and 4/6/2022, and signed by HHA [home health aide] G. Review of the HHA notes failed to evidence the date of the patient's last bowel movement. When informed of the findings, on 4/8/2022, at 3:18 p.m., the administrator and clinical supervisor offered no further information or documentation. 6. Clinical record review on 4/7/2022, for patient #6, start of care 7/30/2021, certification period 7/30/2021 to 9/27/2021, primary diagnosis of Pressure ulcer right buttock, stage 4 (a bedsore that extends to the muscle or bone), evidenced a document titled, "AIDE CARE PLAN", signed on 8/7/2021, by the clinical supervisor. The care plan had a subsection titled, "Intervention", which stated, " ... Temperature (Oral) every visit. Notify SN if above 100 or below 96 ... Respirations every visit. Notify SN if above 22 or below 12 ... Pulse every visit. Notify SN [skilled nurse] if above 100 or below 60 ... Record Bowel Movement every visit...." Clinical record review evidenced documents titled, "Service Note", signed by the home health aide. Review of the notes dated 8/3/2021, 8/5/2021, 8/9/2021, 8/10/2021, 8/16/2021, 8/17/2021, 8/23/2021, 8/24/2021,8/30/2021,8/31/2021, 9/6/2021, failed to evidence a patient pulse, temperature, respiratory rate, and date of last bowel movement. When informed of the findings, on 4/8/2022, at 3:18 p.m., the administrator and clinical supervisor offered no further information or documentation

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all clinical record entries were complete, clear, and accurate in 1 of 2 active records reviewed receiving wound care (#3). The findings include: Record review on 4/8/2022, evidenced an agency policy titled, "Timeliness and Accuracy of Entries in the Clinical Record", dated 1/14/2022, which stated, " ... Each entry into the patient record must be current, accurate, signed, legible, and dated with the date of the entry by the individual making the entry ... Patient records should: Be factual, consistent, and written in a way that the meaning is clear ... All clinicians have a professional and legal duty of care and therefore record keeping should be able to evidence: Full account of the assessment and care planned by the clinician ... Relevant information about the condition of the patient at any given time and measures taken to respond to their needs...." Clinical record review on 4/6/2022, for patient #3, start of care 8/20/2021, certification period 2/16/2022 to 4/16/2022, primary diagnosis of Disruption of external operation wound, evidenced an agency document titled, "CARE NEEDS", dated 2/11/2022, signed by RN (registered nurse) C, which stated, " ... SKIN INTEGRITY, IMPAIRED ... Intervention Cleanse surgical wound with normal saline Apply wound vac at 125 mmhg/continuously Cover surgical wound with dry dressing Pack surgical wound with silver alginate [an absorbent antibacterial dressing] ...." Clinical record review evidenced an agency document titled, "Service Note ... Recertification", dated 2/11/2022, signed by RN C. This assessment had a subsection titled, "Integumentary [skin] Assessment", which stated, " ... Wound Care Cleansed with: NORMAL SALINE Filled with: SILVER ALGINATE Covered with: MEPILEX [an antibacterial foam dressing] / KERLIX [rolled dry gauze] Secured with: TAPE...." During an interview on 4/8/2022, at 3:02 p.m., the clinical supervisor indicated the patient did not have a wound vac on 2/11/2022, and that the Care Needs failed to evidence clear, accurate patient information. 410 IAC 17-15-1(a)(7)