Every finding on record at Northern Indiana Interim Healthcare Company LLC

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 record review, observation, and interview, the Registered Nurse failed to ensure wound care was provided as ordered on the plan of care for 1 of 2 home visits (Patient #13). Findings include: Review of an agency job description dated 10/2017 and titled “Registered Nurse-Home Care” indicated “… provides services that are ordered by the physician as indicated in the plan of care ….” Review of an agency policy dated 04/02/2021 and titled “Implementing the Plan of Care/Service Plan” indicated “… provides care/service in accordance with the Plan of Care/Service Plan ….” Review of the clinical record of Patient #13 included a plan of care (POC) for certification period 11/16/2022 – 01/14/2023 that indicated “… wound care orders … SN (skilled nurse) … cleanse/irrigate wound with mild soap and water ….” A home visit was conducted on 12/28/2022 at 10:00AM with Patient #13, with RN (registered nurse) #2 and family member present. While performing wound care, RN #2 was observed cleaning all seven wounds with normal saline. The observation of the RN providing wound care failed to evidence the RN was following the POC. During an interview on 12/28/2022 at 3:30PM, when asked if the SN is following the POC when observed using normal saline for cleaning of wounds rather than use of mild soap and water, the chief clinical officer indicated no they are not following the POC. 410 IAC 17-14-1(a)(1)(H)

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 observation, record review, and interview, the agency failed to ensure all clinical record entries were complete, and appropriately authenticated for 1 of 2 records reviewed with home visits (Patient #13). This practice had the potential to affect all agency patients. Findings include: Review of an agency policy dated 01/13/2018 and titled “Follow-Up Comprehensive Assessment” indicated “… comprehensive assessment (clinical assessment of the patient) is completed to accurately reflect the patient’s status at the time of the assessment … purpose … to gather information that accurately reflects the patient’s/client’s current health status ….” Review of an agency policy dated 04/02/2021 and titled “Entries in the Patient/Client Record” indicated “… entries into the patient/client record include … accurate … data regarding patient/client … description of care/service provided … documentation of … supplies used during the delivery of care ….” Review of an agency job description dated 10/2017 and titled “Registered Nurse-Home Care” indicated “… provides services that are ordered by the physician as indicated in the plan of care ….” Review of the clinical record of Patient #13 included a plan of care (POC) for certification period 11/16/2022 – 01/14/2023 that indicated “… orders for discipline and treatment … nursing … SN (skilled nurse) to perform complete physical assessment each visit with emphasis on pressure ulcers … SN to perform medication review each skilled nursing visit and reconcile medications … wound care orders … cleanse/irrigate wound with mild soap and water ….” A home visit was conducted on 12/28/2022 at 10:00AM with Patient #13, with RN (registered nurse) #2 and family member present. RN #2 was observed measuring the length and width of patients’ seven wounds. While performing wound care, RN #2 was observed cleaning all seven wounds with normal saline. Review of an agency document titled “Skilled Nurse Visit” for 12/28/2022 indicated “… plan of care review … new/changed orders to POC (plan of care) required no … comment … pt (patient) family member reported does give Tylenol to patient when showing s/s (signs or symptoms) of discomfort … wound care flowsheet … Wound #12 … depth: 0.1 cm (centimeter) … Wound #11 … Depth: 0.5 cm … treatment performed … cleansed … wound with mild soap and water … Wound #10 … treatment performed … cleansed … wound with mild soap and water … Wound #6 … Depth: 0.1 cm … treatment performed … cleansed … wound with mild soap and water ….” Clinical record entries failed to evidence accurate documentation as observed RN #2 did not obtain the depth of each wound; failed to evidence accurate documentation as observed RN #2 did not follow the plan of care with use of mild soap and water for each wound; and failed to evidence accurate documentation as no conversation was heard between RN #2 and family regarding use of Tylenol for discomfort. During an interview on 12/28/2022 with RN #2 following home visit, when asked if depth of wounds were measured, RN #2 indicated had forgotten to measure depth of wounds today. During a phone interview following home visit on 12/28/2022 at 11:50AM, when asked if the patient received pain medication for wounds, the family member indicated the patient is given Tylenol. During an interview on 12/28/2022 at 3:30PM, when asked if Tylenol should be included in the POC for a patient who receives this medication, the chief clinical officer indicated yes. During an interview on 12/29/2022 at 2:35PM, when asked why the documentation for the visit made on 12/28/2022 indicated RN #2 used mild soap and water with cleansing of three of the wounds when observed RN #2 use normal saline with each wound, the chief clinical officer reviewed the documentation and agreed the documentation was not correct. When asked why the documentation for the visit made on 12/28/2022 indicated RN #2 measured the depth of three wounds when observed RN #2 did not measure the depth of any wound, the chief clinical officer reviewed the documentation and agreed the documentation was not correct. When asked why the documentation for the visit made on 12/28/2022 indicated RN #2 had a conversation with family member regarding the use of Tylenol for discomfort when no conversation regarding use of Tylenol was heard during the visit, the chief clinical officer indicated the nurse may have called the family member after the visit and will need to check with RN #2. No additional response provided for this question. 410 IAC 17-15-1(a)(7)

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Survey Dates: November 3, 4, 7, 9, 10; 2022 Census: 103 At this Emergency Preparedness survey, Interim Healthcare of Fort Wayne was found to be out of compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. QR: 11/28/22 Area 2

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 home health agency failed to identify a process to notify authorities of patients/staff who cannot be located in an emergency, which had the potential to affect all patients and staff. Review of the agency emergency preparedness binder failed to include a process to notify authorities of patients and/ or staff who cannot be located during an emergency, with the potential to affect all patients and employees. During an interview on 11/10/2022 at 11:07 AM, the Administrator confirmed the process was not included in the emergency plan and showed the surveyor where the process should have been in the plan. The Administrator indicated the process was mistakenly left out of the plan. Findings included:

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to include contact information for federal, state, regional, and local emergency officials in 1 of 1 agency surveyed, with the potential to affect all patients and employees. 1. Review of the agency emergency preparedness binder failed to include contact information for federal, state, regional, and local emergency officials. The binder evidenced a blank contact information form. 2. During an interview on 11/10/2022 at 11:07 AM, the Administrator confirmed the contact information was not completed and stated, “Clearly I’ve got to fill that out.” 3. During an interview on 11/10/2022 at 2:54 PM, the Administrator provided a completed contact information sheet for emergency officials. The Administrator confirmed the form was completed after the review of the emergency preparedness plan. Findings included:

This visit was for a Federal Recertification and State Relicensure survey of a home health care provider. The survey was announced as fully extended on 11/09/2022 at 5:07 PM. Survey Dates: November 3, 4, 7, 9, and 10; 2022. Census: 103 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. During this Federal Recertification Survey, Interim Healthcare of Fort Wayne was found to be out of compliance with Conditions of Participation 42 CFR 484.60 Care planning, coordination of services, and quality of care and 484.75 Skilled professional services. QR: Area 2 11/28/22 Based on the Condition-level deficiencies during the November 10, 2022, survey, Interim Healthcare of Fort Wayne was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on October 18, 2022. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, Interim Healthcare of Fort Wayne is precluded from providing its own home health aide training and competency evaluation programs for a period of two years beginning November 10, 2022 and continuing through November 9, 2024.

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 home health agency failed to ensure the comprehensive assessment included a current and accurate assessment of the patient in 4 of 11 clinical records reviewed (Patient #2,4,7,8). Review of a policy titled “Initial Comprehensive Assessment,” dated 04/02/2021, indicated “…the comprehensive assessment is completed to accurately reflect the individual’s status at the time of the assessment… the assessment may include gathering information from a variety of sources… eg., facility…” Review of the clinical record for Patient #8 included a comprehensive assessment on the start of care date of 03/14/2022. The assessment included but not limited to a “Wound Care Flowsheet.” This flowsheet evidenced pressure ulcers to the right heel, left heel, sacrum (the area above the tailbone), and the left thigh. The flowsheet failed to include assessment of wound measurements, tissue type, surrounding tissue, wound edge, and wound pain. During an interview on 11/09/2022 at 4:23PM, the administrator indicated wounds should have been assessed even if wound care was already completed by the caregiver that day or dressing change was not ordered for that day. The administrator also indicated the comprehensive assessment should have included assessment of all the patient's active problems and pain should have been assessed every visit with physician notified if pain was outside of the patient's parameters. Review of the clinical record of Patient #2 included a plan of care for the recertification period of 09/18/2022 – 11/18/2022, which indicated a start of care date of 01/21/2022. The plan of care indicated the patient’s diagnoses included but were not limited to xeroderma pigmentosum (extreme sensitivity to sunlight), intellectual disability, cerebral palsy, and seizures. The plan of care indicated nursing interventions included but were not limited to “… SN [Skilled Nurse] for comprehensive assessment … SN to assess pain level and effectiveness of pain medications and current pain management therapy every visit … Prepare and give formula/food at mealtimes and as [Patient #2’s caregiver] indicates … Prepare and give formula/food at mealtimes and as [Patient #2’s caregiver] indicates. SN to perform a neurological assessment each visit. SN to assess … seizure disorder signs and symptoms ….” The record included a comprehensive assessment completed on 09/13/2022 by the Alternate Clinical Manager. The assessment indicated Patient #2 was nonverbal, could “help let her needs be known,” and their pain was rated as a “0,” however the assessment failed to evidence how the patient’s pain was evaluated. The assessment failed to evidence the nurse conducted an assessment of Patient #2’s current seizure activity (most recent seizure(s), type of seizure, etc) and failed to evidence a Fall Risk Assessment was completed. A home visit observation was conducted on 11/03/2022 at 3:25 PM with Patient #2 and Registered Nurse (RN) #1. During the visit, RN #1 confirmed they assessed Patient #2’s pain using a FLACC pain scale (Face, Legs, Activity, Cry, and Consolability; scale used to assess a non-verbal patient’s pain based on their behaviors, results in a numerical rating of pain between 0-10). Review of the clinical record of Patient #4 included a plan of care for the initial certification period of 10/06/2022 – 12/04/2022, which indicated a start of care date of 10/06/2022. The plan of care indicated the patient’s diagnoses included but were not limited to left lower leg cellulitis (infection of the skin), atrial fibrillation (irregular heart rhythm), and Type 2 Diabetes. The plan of care included orders for skilled nursing services and indicated nursing interventions included but were not limited to “… SN to perform complete physical assessment each visit … SN to assess other co-morbidities including [diabetes, high blood pressure] … SN to provide skilled assessment … to properly assess, manage and mitigate pain … SN to assess cardiovascular status … SN to assess diabetic status, identify any signs and symptoms of impaired diabetic function ….” The record included a comprehensive assessment completed on 10/06/2022 by RN #2. The assessment failed to evidence the nurse conducted a complete assessment of Patient #4’s Type 2 Diabetes (frequency of blood sugar testing, presence or absence of symptoms of high or low blood sugar) and atrial fibrillation (presence or absence of signs and symptoms), and failed to evidence the patient’s current pain regimen. Review of the clinical record of Patient #7 included a plan of care for the recertification period of 11/04/2022 – 01/02/2023 and indicated a start of care date of 05/13/2021. The plan of care indicated patient diagnoses included but were not limited to Stage 4 pressure ulcer (wound caused by prolonged pressure on an area of the body, categorized by “stages” between 1-4, with 1 being the least amount of tissue damage and 4 being the most amount of tissue damage) to the left buttock, Stage 3 pressure ulcer to the sacrum, and atrial fibrillation. The plan of care indicated nursing interventions included but were not limited to “… SN to perform complete physical assessment each visit … SN to assess other co-morbidities ….” The record included a comprehensive assessment completed on 11/03/2022 by RN #2. The assessment failed to evidence the nurse conducted a complete assessment of Patient #7’s atrial fibrillation. During an interview conducted on 11/09/2022 at 4:23 PM with the Administrator/Clinical Manager, the Administrator/Clinical Manager reported during the comprehensive assessment the nurse should assess for all “active problems.”

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the patient’s medication list included an indication for administration for all as-needed medications and failed to ensure the patient’s medication list included clear directions on which medication to administer for multiple medications with the same as-needed indication for administration for 6 of 11 records reviewed (Patients #1, 2, 3, 4, 6, 10). Review of the clinical record for Patient #10, start of care 3/7/2022, with diagnoses which included, but not limited to a pressure ulcer on the right heel, peripheral vascular disease (narrowed blood vessels in the limbs), and chronic obstructive pulmonary disease (blocks the airflow, making it difficult to breathe), included a medication profile, completed as part of the assessment process. The medication list included Oxycodone (opioid pain reliever) 10 milligrams (mg) every four hours as needed. The profile failed to identify the indication for the use of the medication. Review of clinical record for Patient #11, start of care 9/19/2022, with a diagnosis of a femur (thigh bone) fracture, included a medication profile, completed as part of the assessment process. The medication list included Tramadol (a narcotic pain reliever) 50 milligrams (mg) every 4 hours as needed. The profile failed to identify the indication for the use of the medication. Review of a policy titled "Medications," dated 12/21/2021, indicated "... The designated qualified nurse provides the patient/ caregiver with medication instructions that include at a minimum... safe and effective use of the medication... dosage... special directions and precautions for... self-administration as appropriate..." Review of clinical record for Patient #1, start of care 9/20/2022, included a medication profile, completed as part of the assessment process. The medication list included nitroglycerin (a medication to treat chest pain) 0.4 milligrams (mg) every 5 minutes PRN (as needed) x3. The profile failed to identify the indication for the use of the medication. Review of clinical record for Patient #3, start of care 9/10/2020, included a medication profile, completed as part of the assessment process. The medication list included albuterol (a medication used to prevent bronchospasm, when the muscles that line the airways in your lungs tighten) 50 milligrams (mg) every 4 hours as needed. The profile failed to identify the indication for the use of the medication. During a home visit with Patient #6 on 11/04/2022, observed a bottle of vitamin D3 2,000 units, 2 bottles levothyroxine 50 mcg (micrograms), and 1 bottle levothyroxine 75 mcg. Review of the discharge summary, dated 10/11/2022, from the skilled nursing facility Patient #6 was treated prior to beginning home health care indicated but not limited to “… Allergies: Codeine, Ceftin, Keflex, Zithromax, Sulfa Antibiotics…” and “…Current Outpatient Medications… cholecalciferol, vitamin D3, 50 mcg (2,000 unit) Cap Take 2,000 units by mouth daily…levothyroxine… 75 mcg tablet Take 1 tablet (75 mcg total) by mouth every morning before breakfast… Review of clinical record for Patient #6, start of care 10/14/2022, included a medication profile, completed as part of the assessment process. The medication list failed to include Patient #6’s drug allergies, failed to include cholecalciferol (vitamin D3), and failed to specify the dosage of the levothyroxine. During an interview on 11/04/2022 starting at 1:35PM, the administrator confirmed all PRN (as needed) medications should include indications for their use and confirmed Patient #1 had no indications on the medication list for PRN nitroglycerin. During a phone interview on 11/07/2022 at 1:35PM, RN (Registered Nurse) #3 indicated they did not observe the vitamin D3 in Patient #6’s home at the time they compleed the comprehensive assessment. When asked the dosage for Patient #6’s levothyroxine, RN #3 indicated they would have to look at the medication list. RN #3 then indicated they would have to look back at the patient’s original documentation and get back to me. No return phone call was received from RN #3. During an interview on 11/07/2022 starting at 3:48PM, the administrator confirmed all medications on the medication list should include the dosage, all skilled staff should be checking medication bottles in the patient’s home against the medication list at every visit, and when admitting a patient recently discharged from a facility skilled staff should compare the patient’s medication list from the facility to the medications in the patient’s home. The clinical record of Patient #2 was reviewed on 11/09/2022 and included a plan of care for the recertification period of 09/18/2022 – 11/18/2022, which indicated a start of care date of 01/21/2022. The record included a comprehensive assessment completed on 09/13/2022 by the Alternate Clinical Manager which included a list of Patient #2’s medications. The medication list included the medications Albuterol (given to treat shortness of breath and/or wheezing) and Neosporin (given to treat or prevent bacterial infections of the skin) which were to be given as needed, but failed to evidence an indication for administration of either medication. The medication list also indicated Patient #2 had three as-needed medications, Naproxen, Tylenol, and Hydrocodone, to be given for pain and/or fever, and two as-needed medications, Miralax and Probiotic Formula, to be given for constipation. The medication list failed to evidence clear directions as to which medication was to be given in what order for the indications of pain, fever, or constipation. The clinical record of Patient #4 was reviewed on 11/09/2022 and included a plan of care for the initial certification period of 10/06/2022 – 12/04/2022, which indicated a start of care date of 10/06/2022. The record included a comprehensive assessment completed on 10/06/2022 by RN #2, which included a list of Patient #4’s medications. The medication list included the medication Insulin Lispro (short-acting insulin given to lower blood sugar) to be given “per sliding scale,” however the medication list failed to evidence the patient’s specific sliding scale (a varied dose of insulin which the amount given depends on the patient’s blood sugar level at the time of administration).

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the plan of care included orders for all services required by the patient and goals which were patient-specific and measurable (see Tag G574) and failed to notify the physician of changes in the patient’s wound status nor of home health aide visits which did not meet the ordered frequency or duration (see Tag G590). The cumulative effect of this systemic problem resulted in the agency being found of compliance with Condition of Participation 42 CFR 484.60 Care planning, coordination of services, and quality of care.

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 the plan of care included orders for all services required by the patient and goals which were patient-specific and measurable for 3 of 8 active records reviewed (Patients #4, 5, 7). 2. The clinical record of Patient #4 was reviewed on 11/09/2022 and included a plan of care for the initial certification period of 10/06/2022 – 12/04/2022, which indicated a start of care date of 10/06/2022. The plan of care indicated goals included but were not limited to “… Patient will obtain optimal effectiveness of pain management regimen by 11-25-22 … Patient will have promotion of healing and restoration of skin integrity without complications by 12-4-22. Patient/Caregiver will achieve optimal wound healing without further [signs or symptoms] of infections or complications by 12-4-22 ….” The plan of care failed to evidence all goals were measurable and patient-specific. 4. Review of the clinical record of Patient #7 included a plan of care for the recertification period of 11/04/2022 – 01/02/2023 and indicated a start of care date of 05/13/2021. The plan of care indicated patient diagnoses included but were not limited to Stage 4 pressure ulcer (wound caused by prolonged pressure on an area of the body, categorized by “stages” between 1-4, with 1 being the least amount of tissue damage and 4 being the most amount of tissue damage) to the left buttock and Stage 3 pressure ulcer to the sacrum. The plan of care indicated goals included but were not limited to “… Patient will demonstrate safe nutritional intake and measures to decrease risk of aspiration by end of care period ... Caregiver will demonstrate measures to prevent skin breakdown. Skin integrity will be maintained throughout the episode of care. Caregiver will demonstrate appropriate skin care precautions by end of care period ….” The plan of care failed to evidence all goals were measurable and patient-specific. 6. During an interview on 11/09/2022 starting at 4:23PM, the administrator confirmed all goals should be patient-specific and measurable. 1. Review of a policy titled “Developing a Plan to Meet Patient/ Client Needs, When Orders for Care/ Service are Required,” dated 04/02/2021 indicated “… A qualified designated employee obtains orders for care/ service prior to the delivery of such, and… ensures a patient’s individualized home health plan of care includes the following… the types of services… measurable outcomes and goals identified by the HHA [home health agency] and the patient…” 3. Review of the clinical record for Patient #5, start of care 11/04/2022, included a recertification assessment signed and dated 10/05/2022 by RN (registered nurse) #4. This assessment indicated “… No Skilled Service Needed…” The clinical record for Patient #5 also included a POC signed and dated 10/05/2022 by RN #4 which indicated orders for services including but not limited to nursing every 2 weeks for including but not limited to “SN [skilled nursing] to assess/ instruct on signs & symptoms of pulmonary (lung) complications… SN to perform neurological assessment each visit… SN to assess/ instruct on pain management…” 5. During a phone interview on 11/09/22 starting at 3:49PM, RN #4 confirmed they were the case manager for Patient #5 and indicated they perform supervisory visits for the home health aide every 2 weeks during which they assess pulmonary and neurological status but only document abnormals for those outside of the comprehensive assessment. 7. During an interview on 11/09/2022 starting at 4:23PM, the administrator indicated Patient #5 should not have orders for skilled nursing visits on the POC. They indicated nursing should have aide supervision visits and recertification visits only.

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 home health agency failed to notify the physician of changes in the patient’s wound status and failed to notify the physician of failure to follow physician orders for frequency and length of visit for 3 of 8 active patient records reviewed (Patient #3,4,7. 3. Review of the clinical record of Patient #4 included a plan of care for the initial certification period of 10/06/2022 – 12/04/2022, which indicated a start of care date of 10/06/2022. The plan of care indicated nursing interventions included but were not limited to “… SN [Skilled Nurse] recognize and intervene to minimize complications; notify physician immediately of any potential problems that impede completion of patient recovery and desired goals … SN to assess integumentary status, identify any signs and symptoms of impaired skin integrity, report significant changes to physician … SN indicated for wound care management based on physician orders ….” The record included a comprehensive assessment completed on 10/06/2022 by RN #2 which indicated the patient had three wounds on the left anterior lower leg - one to the medial side, one to the upper lateral side, and one to the lower lateral side. The record included a skilled nursing visit note conducted on 10/10/2022 by Registered Nurse (RN) #3 which indicated Patient #4 had 100% slough (dead tissue which requires removal for wound healing) to their upper distal leg wound (a change from the previous visit on 10/7/2022). The record failed to evidence the nurse notified the patient’s physician of the change in wound tissue. The clinical record included a skilled nurse visit note conducted on 10/12/2022 by Licensed Practical Nurse (LPN) #1 which indicated the patient had 100% slough to the medial leg wound, which was a change from the previous visit (10/10/2022). The record failed to evidence the nurse notified the patient’s physician of the change in wound tissue. The clinical record included a skilled nurse visit note conducted on 10/14/2022 by LPN #1 which indicated the patient’s lower distal leg wound measured 5 centimeters (cm) in length by 2.5 cm in width by 4 cm in depth, an increase of 2 cm in depth from the previous measurement on 10/07/2022. The record also indicated the patient continued to have 100% slough to their medial leg wound, however the record failed to evidence the nurse notified the physician of the change in wound measurement or presence of slough in one of the wounds. The clinical record included a skilled nurse visit note conducted on 10/21/2022 by LPN #1 which indicated the patient’s lower distal wound measured 4.7 cm in length by 2.3 cm in width by 5.1 cm in depth, an increase of 1.1 cm in depth from the previous measurement on 10/14/2022. The record failed to evidence the nurse notified the physician of the increase in wound depth. 4. Review of the clinical record of Patient #7 included a plan of care for the recertification period of 11/04/2022 – 01/02/2023 and indicated a start of care date of 05/13/2021. The plan of care indicated patient diagnoses included but were not limited to Stage 4 pressure ulcer (wound caused by prolonged pressure on an area of the body, categorized by “stages” between 1-4, with 1 being the least amount of tissue damage and 4 being the most amount of tissue damage) to the left buttock, Stage 3 pressure ulcer to the sacrum, and atrial fibrillation. The plan of care included orders for skilled nursing services for 2 visits per week for 8 weeks then 1 visit per week for 1 week plus 3 as needed visits for foley catheter or wound complications. The plan of care also indicated nursing interventions included but were not limited to “… SN to complete physical assessment each visit with emphasis on pressure ulcers … SN to recognize and intervene to minimize complications; notify physician immediately of any potential problems that impede completion of patient recovery and desired goals ….” The record included a skilled nurse visit note conducted on 09/22/2022 by RN #2. The visit note indicated Patient #7’s coccyx wound measured 5 cm in length by 2.5 cm in width by 0.1 cm in depth, an increase in 1 cm from the previous measurement on 09/19/2022. The record failed to evidence the nurse notified the physician of the change in wound measurement. The clinical record included a skilled nurse visit note conducted on 10/13/2022 by RN #2 which indicated the wound tissue of the patient’s coccyx wound was 10% slough, which was a change from the previous assessment (10/10/2022). The record failed to evidence the nurse notified the patient’s physician of the change in wound tissue. The clinical record included a skilled nurse visit note conducted on 11/03/2022 by RN #2 which indicated the wound tissue of the patient’s coccyx wound was 50% slough, which was a change from the previous assessment (10/31/2022). The record failed to evidence the nurse notified the patient’s physician of the change in wound tissue. Findings included: Review of a policy titled “Variances from the Plan of Care/ Service Plan,” dated 04/02/2021, indicated “… establishes the expectation and ensures that processes are in place whenever possible to avoid care/ service and visit/ shift variances from the plan of care/ service plaaaan and to manage such appropriately when it occurs… if alternative means cannot be identified and the patient/client will be put at risk by not filling the visit/ shift/ hour requirement, then… notifies all parties including any ordering physician… tracks the frequency and reasons for missed visit/ shift or reduced hour variances and periodically analyzes trends… if a pattern of missed visits/ shifts… collaborates with the Administrator/ Manager to develop and implement a plan of action to reduce visit/ shift variances by… developing and implementing a corrective plan of action… the care manager or designee provides on-going monitoring to determine that care/ service plans are being followed as written… investigates the circumstances of the care/ service variance… notifies the ordering physician… documents actions taken in the patient’s/ client’s record…” Clinical record review of Patient #3, start of care 09/10/2020, evidenced multiple missed home health aide (HHA) visits and multiple HHA visits shorter than the ordered visit length. The physician ordered plan of care for certification periods 08/31/2022 – 10/29/2022 and for 10/30/2022 – 12/28/2022 indicated orders for HHA visits 6 times per week for 9 weeks with visits of 4-8 hours per day. Missed visit notes were entered for including but not limited to 09/02/2022, 09/05/2022, 09/09/2022, 09/16/2022, 09/23/2022, 09/30/2022, 10/01/2022, 10/07/2022, 10/14/2022, 10/21/2022, 10/28/2022, and 11/04/2022. These missed visit notes indicated “no” to the prompt “Physician Office Notified.” HHA visit notes dated 09/06/2022, 09/07/2022, 09/20/2022, 10/04/2022, 10/13/2022, and 10/25/2022 indicated visit lengths ranging from 3 hours to 3.75 hours. The clinical record failed to evidence physician notification of these visits which lasted fewer than the minimum ordered hours. During an interview on 11/09/2022 at 4:23pm, the administrator indicated the physician should be notified of any missed visits and visits that are fewer than the minimum ordered hours. When asked about a corrective action plan for patient’s missed visits, the administrator indicated they would look into it. No such plan was provided.

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, policy review, and interview the home health agency failed to follow accepted standards of practice and their own policies to prevent the transmission of infections and communicable diseases for 2of 5 patient visits observed (Patient #6,7.) 3. During a home visit observation on 11/07/2022 beginning at 11:34 AM with Patient #7 and Registered Nurse (RN) #2. During the visit, the nurse was observed assessing and providing wound care to the patients’ two wounds. The nurse failed to perform change gloves and perform hand hygiene in between providing wound care to the two wounds Findings included: Review of policy titled “Exposure Control Plan, Engineering Controls and Work Practices,” dated 06/24/2011, indicated but was not limited to “… employees use standard precautions to reduce the risk of transmission of bloodborne pathogens as well as other potentially infectious material... employees wash their hands…immediately before using gloves and immediately after removal of gloves… moving from a contaminated body site to a clean body site during patient care… immediately after handling or contact with any contaminated material…employees clean equipment carried in their equipment/ supply bag with a disinfectant… after each use and before returning to the equipment/supply bag… ” During a home visit observation on 11/04/2022 starting at 3:01PM with Patient #6 (start of care 10/14/2022) and Physical Therapy Assistant (PTA) #1, PTA #1 failed to clean the vital sign equipment before returning to the bag. During an interview on 11/04/2022 beginning at 3:41PM, PTA #1 indicated they wiped down equipment in the car between patients. When asked, PTA #1 confirmed they returned the equipment to the same pocket used for dirty equipment. During an interview on 11/07/2022 beginning at 3:48PM, the administrator indicated the agency process for cleaning equipment between patients was to use sani-wipes after use and to put cleaned equipment in a clean section of the bag and indicated the nurse should change gloves and perform hand hygiene after performing wound care on one wound and before moving on to the next wound. 410 IAC 17-12-1(m)

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse and Licensed Practical Nurse failed to assess for the presence or absence of tube feeding residual, failed to accurately measure a wound, and failed to assess all areas at high risk for skin breakdown (See G706) and the Physical Therapist failed to supervise and document the supervision of physical therapy assistants according to agency policy (See G728). Based on the cumulative effect of this systemic problem, the agency was found to be out of compliance with Condition of Participation 42 CFR 484.75 Skilled professional services.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the Registered Nurse (RN) and Licensed Practical Nurse (LPN) failed to assess for the presence or absence of tube feeding residual for 1 of 1 home visit of a patient with a G-tube (Patient #2) and failed to accurately measure a wound for 1 of 2 home visits of a patient with a wound (Patient #4) respectively, and failed to assess all areas at high risk for skin breakdown for 2 of 2 RN visits conducted (Patients #4 and 7). Findings included: 1. An agency policy titled “Examples of Standards of Practice,” dated 12/21/2021, indicated but was not limited to “… Wound: The clinician measures the wound(s) weekly and documents the results. The clinician documents the appearance of the wound(s) each dressing change ….” 2. An agency job description for the role of Registered Nurse, revised 10/2017, indicated but was not limited to “… Essential Functions: Participates in ongoing interdisciplinary assessment ….” 3. An agency job description for the role of Licensed Practical Nurse, revised 10/2017, indicated but was not limited to “… Essential Functions: Participates in ongoing interdisciplinary assessment ….” 4. A home visit observation was conducted on 11/03/22 at 3:25 PM with Patient #2 (start of care 01/21/22) and Registered Nurse (RN) #1. During the visit, RN #1 indicated Patient #2 had a G-tube (a tube surgically inserted into the stomach to bypass eating and/or taking medications by mouth) which the nurse used to administer nutrition and medications during their shift. When queried if RN #1 checked the patient’s G-tube for residual, the nurse indicated they did not routinely perform this assessment. 5. Review of the clinical record of Patient #4 included a plan of care [POC] for the initial certification period of 10/06/22 – 12/04/22, with SOC of 10/06/22. The POC indicated nurse interventions included, but were not limited to, “… SN [Skilled Nurse] to perform complete physical assessment each visit … SN to assess integumentary status, identify any signs and symptoms of impaired skin integrity, report significant changes to physician … SN indicated for wound care management based on physician orders.” A home visit observation was conducted on 11/04/22 at 10:15 AM with Patient #4 and Licensed Practical Nurse (LPN) #1. During the visit, the LPN assessed the Patient #4’s three wounds on the left anterior lower leg, one to the medial side, one to the upper lateral side, and one to the lower lateral side. The nurse measured the undermining of the upper and lower lateral leg wounds and reported the measurement as the wound’s depth, not undermining. When the nurse was queried on how they measured Patient #4’s wounds, LPN #1 reported the patient had no tunneling or undermining. During the home visit observation, the LPN failed to assess the patient’s peripherally inserted central catheter (PICC, long IV placed into a large vein for long term use) and failed to assess the patient’s skin of the right leg stump. 6. Review of the clinical record of Patient #7 included a POC for the recertification period of 11/04/22 – 01/02/23 with a SOC of 05/13/21. The POC indicated patient diagnoses included but were not limited to Stage 4 pressure ulcer (wound caused by prolonged pressure on an area of the body, categorized by “stages” between 1-4, with 1 being the least amount of tissue damage and 4 being the most amount of tissue damage) to the left buttock and Stage 3 pressure ulcer to the sacrum. The POC included nursing interventions, not limited to, “… Patient identified to be at risk for pressure ulcer development. SN to provide skilled assessment.” During a home visit observation, conducted on 11/07/2022 at 11:34 AM, with Patient #7 and Registered Nurse (RN) #2, the nurse assessed the patient’s two wounds though failed to measure the length, width, or depth of the wound and failed to assess the patient’s heels for presence or absence of wounds. After the home visit, when queried to an assessment of the patient's heels, RN #2 confirmed they did not assess and stated they were only able to measure the length, width, and depth of the wound due to its shape. 7. During an interview conducted on 11/07/22 at 3:48 PM, the Clinical Manager confirmed the nurse should assess for the presence or absence of tube feeding residual for all patients with a G-tube, measurement of a wound should include length, width, depth, and presence or absence of undermining and/or tunneling, and for a patient who was high risk for skin breakdown, the nurse should assess all of a patient’s bony areas for the presence or absence of wounds at each visit.

Rehab services supervised by PT, OT CFR(s): 484.75(c)(2) Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of §484.115(f) or (h), respectively. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure physical therapy assistants received supervision from a physical therapist in 3 of 4 patients who received services from a physical therapy assistant for more than one month, when supervision visits were required (Patients #8, 10, and 11). Review of the clinical record for Patient #8, start of care date 03/14/2022, failed to evidence a supervision note by the physical therapist regarding the physical therapy assistant. 1. Review of Indiana Code 25 – 27 -1 – 13, available at https://iga.in.gov/ legislative/laws/2021 /ic/titles/025/#25-27-1-13, identified supervision duties of the Physical Therapist, which include, but not limited to, “… the use of physical therapist assistants to ensure that the delivery of care is safe, effective and efficient …” and “… a physical therapy assistant shall work under a physical therapist’s supervision ….” 2. Review of an agency policy “Supervision of Employees Who Provides [sic] Patient/ Client Care/ Service” dated 1/13/2018 stated, in part, “… supervisory visits are conducted in accordance with applicable law ….” The policy further indicated physical therapy services were provided under the supervision of a qualified physical therapist. 3. Review of the clinical record for Patient #10, start of care date 3/7/2022, evidenced a Physical Therapy Reassessment dated 6/2/2022 and completed by Physical Therapist 2. The document failed to include a supervision note for Physical Therapy Assistant (PTA) 4. 4. Review of the clinical record for Patient #11, start of care date 9/19/2022, evidenced a Physical Therapy Reassessment dated 10/18/2022 and completed by Physical Therapist 3. The document failed to include a supervision note for PTA 1. 5. During a phone interview on 11/10/2022 at 12:08 PM, Physical Therapist 2 explained the PTA supervision process. Physical Therapist 2 indicated PTA supervisory visits occurred every thirty days, with the physical therapy reassessment. Physical Therapist 2 indicated there was a separate supervision document that could be opened and completed or the physical therapy reassessment form had a process to access the supervision document while charting the reassessment findings. 6. During an interview on 11/10/2022 at 1:57 PM, the Administrator confirmed the supervision notes for PTA 4 and PTA 1 were not completed.

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 home health agency failed to ensure the aide care plan assigned only appropriate tasks for a home health aide for 2 of 2 patients reviewed who received home health aide services (Patient #3 and 5). Findings included: 1. Review of policy titled “Supplemental and Delegated Tasks for Home Care Aides” indicated but not limited to “…professional clinicians may delegate tasks to home care aides in accordance with applicable law and regulation.” 2. Review of a document by Indiana Family and Social Services Administration titled “Indiana Health Coverage Programs Provider Reference Module: Home Health Services, Policies & Procedures as of May 1, 2022,” indicated “…non-covered services…transporting the member to grocery stores, pharmacies, banks and so forth.” 3. Record review for Patient #3, start of care 09/10/2020, included a plan of care [POC] for the recertification period 10/30/22 - 12/28/22 with physician orders for home health aide (HHA) services 4-8 hours per day, 6 days per week to assist with ADLs (activities of daily living). The record included a document titled “HHA Care Plan,” signed by registered nurse [RN] #3 and dated 10/26/22, that evidenced the aide was assigned tasks that included Transportation, and included, "Aides Car – non emergent transport… Per Clients Car – non emergent transport.” These tasks had the instructions to notify the office before leaving the patient’s home of destination. 4. Record review for Patient #5, SOC 11/04/02, included a POC for recertification period 10/10/22 - 12/08/22 that included physician ordered HHA services, 3-5 hours per day, 5 days per week, to assist with ADLs. Record review included document titled “HHA Care Plan” signed by RN #4, dated 10/06/22, that evidenced tasks assigned included, but not limited to, “Category: Transportation… Per Clients Car – non emergent transport,” with added instructions to notify the office before leaving the patient’s home of destination. 5. During an interview on 11/07/22, the administrator indicated their aides may ride with a patient in the patient’s car for any payor source but may not transport (drive) the patient if they have traditional Medicaid.