Every finding on record at Laporte Home Care Services, LLC

Ensure training/competency requirements CFR(s): 484.80(h)(5)(iii) Ensuring that home health aides who provide services under arrangement have met the training or competency evaluation requirements, or both, of this part. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aides provided under arrangement had met the training or competency evaluation requirements in 1 of 1 home health aide contracted agreement. Findings include: A review of an agency policy revised on 01/01/2023, titled, "Patient Care Contracted Workers Requirement," indicated a job specific orientation was to be completed on each contracted worker, each provider would maintain their own separate personnel record and the personnel records would contain up to date information. A review of an agency home health aide staffing service agreement, received on 11/20/2023, indicated the contracted employees should complete all mandatory orientation training and have the necessary qualifications and certifications to perform staffing services. A review of the documents provided, failed to evidence the agency had provided their contracted home health agency with the agency's orientation, nor documentation that any home health aide of the contracted agency was provided orientation and prepared to provide home health aide services to the agency's patients. During an interview on 11/20/2023 beginning at 3:15 PM, the Administrator indicated when an aide service was required from their contracted agency, the agency's orientation will be provided prior to the home health aide provision of patient care. The administrator indicated they had not yet provided the contracted agency with the home health agency's orientation. The Administrator indicated the contracted home health aide agency was unable to provide personnel records related to home health aide training or competency as the agency had not yet utilized the contracted agencys' home health aide services.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the patient's needs were continually assessed in 1 of 1 active clinical records reviewed with only physical therapy services (Patient #5). Findings include: A review of an agency policy, revised on 09/01/2023 and titled "Coordination of Care, From Admit Through Discharge," indicated the agency would identify patient's needs through assessment and communication with other health care providers and would refer to alternate agencies when the patient required services that were unable to be met by the agency for continuing care needs. A review of a physical therapy OASIS (outcome assessment and information set) Admission note dated 11/13/2023 indicated patient #5 required partial/moderate assistance with bathing and required presence of another person through the bath for assistance, partial/moderate assistance for toilet transfers, able to bear weight and pivot during transfer but unable to transfer self, required partial assistance from another person to complete any activities of daily living, required moderate assistance for basics transfers, was at increased risk for falls, and non-agency caregiver needed training/supportive services to provide assistance. The OASIS Admission note indicated the patient was non-weightbearing and non-ambulatory. A review of the electronic medical records failed to evidence Patient was offered home health aide services. During an interview on 11/21/2023, at 12:44 PM, the Administrator indicated the agency should have offered and documented in the electronic medical record that home health aide services were offered. During an interview on 11/21/2023, at 11:28 AM, family member 5 indicated Patient had a homemaker provided by clinic 4 for laundry and linen changes to bed 10 hours per week; Patient did not have care services for activities of daily living [bathing, grooming, meal preparation, toileting, and position changes]. Family member 5 indicated the family provided Patient with activities of daily living; family member 5 indicated he/she did work outside of the home and additional assistance would help Patient. Family member 5 indicated the home health agency did not offer home health aide services and they did request aide services for Patient.

Primary HHA is responsible for patient care CFR(s): 484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aide contract for services specified how the primary home health aide supervision would occur in 1 of 1 home health aide contracted agreements. Findings include: A review of a home health aide staffing services agreement received on 11/20/2023, failed to indicate the manner in which services will be controlled, coordinated, evaluated, and supervised by the primary home health agency. During an interview on 11/21/2023, at 11:50 AM, the Administrator indicated the manner the primary home health agency would coordinate, supervise, and evaluate the contracting home health aide was not in the staffing agreement. 410 IAC 17-12-2(e)

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 10/06/2023, 10/10/2023, 10/11/2023, 10/13/2023 Active Census: 170

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to have an emergency preparedness plan that included collaboration with local, tribal, regional, State, and Federal emergency preparedness officials to maintain an integrated response during an emergency situation. Findings include: A record review of an agency policy revised on 03/01/2022, titled, “Emergency Preparedness/Operation Plan,” which indicated the Executive Director shall ensure that the agency maintains contact with local/county offices of emergency preparedness. A review failed to evidence documentation of collaboration with local, tribal, regional, State or Federal emergency preparedness officials. During an interview, on 10/10/2023 at 3:00 PM, the Administrator indicated he/she would need to to search for evidence / documentation that they maintained contact with local officials officials in their emergency preparedness planning. During an interview on 10/13/2023, at 3:00 PM, the Administrator indicated he/she had contacted the county emergency preparedness official that day, 10/13/2023.

This was a visit for a Federal Recertification and State Re-licensure of a Home Health Provider Survey Dates: 10/06/2023, 10/10/2023, 10/11/2023, 10/13/2023 Facility ID: IN005255 12-month unduplicated skilled admissions: 615 During the Federal Recertification Survey Indiana Homecare Northwest was found to be out of compliance with Condition of Participation 42 CFR 484.60 Care planning, coordination, quality of care. The deficiency report reflects state findings cited in accordance with 410 IAC 17. Based on the Condition-level deficiency during the October 13, 2023, survey, your home health agency was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 10/11/2023. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 10/13/2023 and continuing through 10/12/2025 QR: A 1 10/26/23

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 home health agency failed to ensure the encoded outcome assessment and information set (OASIS) data accurately reflected the patient’s status at the time the OASIS was completed in 1 of 1 home visit patients with an occupational therapist (Patient #1). Findings include: A review of an agency policy with revision date 06/01/2023, titled, “Patient Assessment, Initial and Reassessment,” indicated OASIS data, assessed and collected, included medications. A review of an agency policy with revision date 05/01/2019, titled, “Monitoring Medications,” indicated all medications would be reviewed to identify issues such as potential adverse effects, drug reactions, significant side effects and contraindicated medications. The policy indicated significant drug interactions at severity level I and II would require notification of the physician. The clinical record for Patient #1 included an agency coordination note, dated 09/20/2023, which documented an identified a level II severe interaction between albuterol (inhaler) and Coreg (heart medication). The OASIS Admission, completed by registered nurse (RN) and dated 09/19/2023, indicated at M2001 there were no medication issues found during review to identify clinically significant medication issues. The RN OASIS Admission, dated 09/19/2023, at M2001 failed to accurately reflect the patient's medication status. During an interview on 10/13/2023, at 12:15 PM, the Clinical Manager indicated the OASIS data at M2001 was incorrect on the admission assessment, and should have indicated medication issues were identified.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment was completed within 48 hours of the referral in 1 of 1 active clinical record reviewed with home health aide services ordered. (Patient #5) The findings include: A clinical record review on 10/11/2023, for Patient #5, start of care 9/22/2023, evidenced a document from Entity 1 titled “Referral Form” dated 9/15/2023, which indicated the patient was referred to the agency for home health services to include home health aide services. Review of an agency document titled “Visit Note Report” dated 9/22/2023, and identified as the admission assessment, indicated the registered nurse completed the initial assessment on 9/22/2023, which was greater than 48 hours from the date of referral. During an interview on 10/11/2023, at 3:12 PM, the Clinical Manager indicated the admission assessment was the initial assessment. The Clinical Manager indicated the agency contacted the referral source to inform them the agency did not offer home health aide services, and a new referral order was sent on 9/20/2023. 410 IAC 17-14-1(a)(1)(A)

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 failed to provide services as ordered in the plan of care (see tag G572); failed to include in the individualized plan of care the types of services, supplies, equipment required, all medications and treatments, visit frequencies, and measurable outcomes and goals identified by the home health agency (see tag G574); failed to conform to physician orders (see tag G578); failed to ensure all treatments provided by agency staff were ordered by a physician (see tag G580); failed to promptly alert physician of any changes that suggest the outcomes are not being achieved and/or the plan of care should be altered (see tag G590); failed to revise the plan of care (see tag G592); and failed to integrate all services to assure the identification of patients' needs that could affect patient safety and treatment effectiveness (see tag G606). 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 of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: 1. A clinical record review on 10/11/2023, for Patient #5, evidenced a document from Entity 1 titled “Referral Form” dated 9/15/2023, which indicated the patient’s diagnoses included, but were not limited to, atrophy (wasting away) of the right ankle/foot, bilateral foot drop, and Parkinson’s disease (a progressive disorder causing uncontrolled movements and difficulty with balance and coordination). Review indicated the patient was referred to the agency for home health services to include home health aide services. Review of an agency document titled “Visit Note Report” completed by the registered nurse, dated 9/22/2023, and identified as the admission assessment, indicated the patient lived alone, required assistance for grooming, dressing, toilet hygiene, sit to stand transfers, and was dependent for ambulation. Review failed to evidence the agency offered and provided home health aide services. Review failed to evidence the patient refused home health aide services. During an observation of care at the home of Patient #5 on 10/11/2023, at 12:41 PM, the skilled nurse was observed applying cream to both of the patient’s legs/feet and socks per patient request because the patient indicated he/she was unable to do so. During an interview on 10/11/2023, at 12:19 PM, Patient #5 indicated he/she lived alone and had a neighbor that checked in but did not provide personal care. Patient #5 indicated he/she was inquiring about transferring into an assisted living facility because home health aide services were needed. Patient #5 indicated the agency had not offered home health aide services. During an interview on 10/11/2023, at 3:18 PM, the Clinical Manager indicated the agency did not provide home health aide services, but the agency could provide an occupational therapist to teach personal care to the patient. The Clinical Manager indicated there was no documentation the agency informed the patient that the agency did not offer home health aide services, did not make a referral to another agency for home health aide services, and did not offer occupational therapy for personal care. XX. A clinical record review evidenced a coordination note dated 9/25/2023 which indicated speech therapy was to evaluate Patient #9 and develop a plan of care to be approved by the physician. A clinical record review on 10/12/2023 failed to evidence any speech therapy visits or patient refusal of speech therapy. During an interview on 10/13/2023 at 3:05 PM, the administrator indicated Patient #9 had not been seen by speech therapy, either by error or patient refusal. 410 IAC 17-13-1(a)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide services as ordered in the plan of care in 1 of 1 home visit with a licensed practical nurse (LPN). (Patient #5) The findings include: A review of an agency policy revised 8/1/2022, titled “Wound Assessment, Documentation, and Photography” stated, “… the qualified clinician … will assess wounds at least: Weekly for patient … have an infected wound … The assessment includes measurement of the length, width, and depth ….” A clinical record review on 10/11/2023, for Patient #5, evidenced a document from Entity 1 titled “Referral Form” dated 9/15/2023, which indicated the patient’s diagnoses included, but were not limited to, a wound to the left foot with gangrene (dead tissue caused by infection or loss of blood flow). Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 9/22/2023-11/20/2023, indicated the skilled nurse was to provide wound care weekly and was to monitor the wound for signs of deterioration. During an observation at the home of Patient #5 on 10/11/2023, at 12:27 PM, a black, dry, scabbed area the size of a quarter was observed on the top of the left foot with a yellow, dry, scaly surrounding area the size of the palm of the hand. LPN 1 was not observed to have measured the wound. During an interview on 10/11/2023, at 1:02 PM, LPN 1 indicated the wound was to be monitored by measuring the wound weekly. Review failed to evidence the wound was measured since 10/5/2023 and failed to evidence another skilled nursing visit for wound care was scheduled until the week of 10/15/2023. During an interview on 10/11/2023, at 3:58 PM, the Clinical Manager indicated a wound with gangrene was considered to be an infected wound and indicated infected wounds should be measured weekly. 410 IAC 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure the plan of care included all equipment required, nutritional requirements, all medications, treatments, visit frequencies, and measurable outcomes and goals in 7 of 9 active clinical records reviewed (Patient #1, 3, 4, 5, 6, 7, 8) and 2 of 4 discharged clinical records reviewed (Patient #12, 13). Findings include: * A clinical record review on 10/11/2023, for Patient #5, evidenced a document from Entity 1 titled “Referral Form” dated 9/15/2023, which indicated the patient’s diagnoses included, but were not limited to, atrophy (wasting away) of the right ankle/foot, bilateral foot drop, a wound to the left foot with gangrene (dead tissue caused by infection or loss of blood flow). Review indicated physical therapy was ordered to teach the patient how to use AFOs (ankle foot orthotics, a type of brace worn to the ankle/foot). During an observation at the home of Patient #5 on 10/11/2023, at 12:27 PM, braces were observed next to the patient’s shoes. Review of agency documents titled “Visit Note Report” completed by the occupational therapist indicated the occupational therapist educated the patient to wear a hand splint the patient had to prevent further contractures on document dated 9/26/2023. Review of document dated 10/9/2023 indicated a hand splint was on the patient’s left hand. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 9/22/2023-11/20/2023, failed to evidence the plan of care included the AFOs. Review indicated the skilled nurse was to perform wound care to the left foot 1 time per week and instruct the patient/caregiver on proper disposal of dressings, but the plan of care failed to include what was the wound care. Review failed to evidence the plan of care included a hand splint. Review indicated the agency was to provide physical therapy 1 time a week for 2 weeks, then every other week for 2 weeks, and then 1 time a week for 2 weeks. Review of an agency document titled “Add On Discipline” completed by the physical therapist and dated 9/25/2023, indicated the agency was to provide physical therapy services 1 time a week for 6 weeks. Review failed to evidence the plan of care was individualized to include the visit frequency as determined by the physical therapist. During an interview on 10/11/2023, at 3:18 PM, the Clinical Manager indicated the AFOs were not included in the plan of care but should be. At 3:27 PM, the Clinical Manager indicated the wound care was to monitor the wound and leave the wound open to air and indicated the plan of care should specify there was no dressing and to leave the wound open to air. At 3:49 PM, the Clinical Manager indicated she was unsure why the frequency on the plan of care was not matching the frequency determined by the physical therapist upon evaluation on 9/25/2023. 1. A record review evidenced a revised agency policy dated 12/01/2021, titled, “Plan of Care,” which indicated the plan of care would include nutritional requirements, medications, treatments, and required equipment and supplies. 2. A record review evidenced a revised agency policy dated 10/01/2023, titled, “Physician Orders,” which indicated medications would be entered to include medication name, frequency, route and PRN (as needed) orders would include indications for use. 3. A clinical record review for patient #1 evidenced a registered nurse (RN) initial assessment dated 09/19/2023, visit which indicated the patient was new to oxygen. A review of the plan of care for certification period 09/19/2023-11/17/2023, failed to evidence oxygen orders. During an interview on 10/10/2023, at 3:31 PM, the Alternate Clinical Manager indicated the oxygen orders should have been included on the plan of care. 4. A clinical record review for patient #7 evidenced a physical therapy initial assessment dated 09/21/2023, which indicated the patient had a non-removable dressing to the right knee. A review of the plan of care for certification period 09/21/2023-11/19/2023, failed to evidence right knee dressing care orders. During an interview on 10/10/2023, at 3:17 PM, the Clinical Manager indicated the plan of care should have included the right knee orders for the dressing not to be removed until the surgeon’s office visit. A review of physical therapy visit notes dated 09/25/2023, and 09/27/2023, evidenced the patient was using a CPM (continuous passive motion) machine to the right knee. During observation of a home visit on 10/10/2023, starting at 10:00 AM, the patient indicated the use of the CPM machine daily at 120 degrees for 1-3 hours per day. A review of the plan of care for certification period 09/21/2023-11/19/2023, failed to evidence use of the CPM machine and the range to be used (-10 to 120 degrees). During observation of a home visit on 10/10/2023, starting at 10:00 AM, the patient indicated the use of a Polar Care Cube (cold therapy) to the right knee every day in 1-hour increments. A review of the plan of care for certification period 09/21/2023-11/19/2023, failed to evidence orders for the Polar Care Cube. During an interview on 10/10/2023, at 3:10 PM, the Alternate Clinical Manager indicated the CPM machine and Polar Care Cube should have been included on the plan of care to include the instructions for use. A review of the plan of care for certification period 09/21/2023-11/19/2023, indicated the patient was taking Hydrocodone/Acetaminophen (pain relieving medication) every 4 hours PRN, but failed to have an indication for the as needed medication. A review of the plan of care indicated the patient was taking aspirin (blood thinner) 325 milligrams one tablet daily. During observation of a home visit on 10/10/2023, starting at 10:00 AM, the patient indicated the use of aspirin 325mg one tablet twice a day for 30 days after knee surgery on 09/20/2023. The plan of care failed to evidence the use of aspirin 325mg one tablet twice a day. During an interview on 10/10/2023, at 3:25 PM, the Clinical Manager indicated the medications should be reconciled at each visit to verify the frequency of the aspirin and the hydrocodone/acetaminophen should have included the PRN indication. 5. A clinical record review for patient #8 evidenced a plan of care for certification period 08/15/2023-10/13/2023, which indicated the patient had a g-tube (tube to the stomach to provide nutrition/medications) with Glucerna (liquid nutrition) via the g-tube. The plan of care indicated the patient had a tracheostomy (tube into the windpipe to allow air to fill the lungs) and was evaluated by speech therapy to evaluate swallowing. A review of the plan of care indicated medications were given via g-tube except for Tramadol (pain reliever) which indicated the route was oral. A review of the plan of care failed to evidence if patient had any oral intake orders and failed to evidence g-tube site care orders. During an interview on 10/13/2023, at 10:13 AM, the Clinical Manager indicated the patient oral intake was supposed to be NPO (nothing by mouth), but the patient did receive pleasure feedings and would assume the Tramadol was to be given via g-tube. The Clinical Manager indicated on 10/13/2023, at 12:37 PM, the plan of care should include the g-tube care orders even if the patient’s family member maintained the g-tube site. 6. A clinical record review for patient #12 evidenced a physical therapist initial assessment dated 08/22/2023, which indicated the patient was to wear a lumbar (lower back) brace due to a back surgery. A review of the plan of care for certification period 08/22/2023-10/20/2023, failed to evidence the use of the lumbar brace. During an interview on 10/13/2023, at 2:52 PM, the Clinical Manager indicated the use of the lumbar brace should have been included on the plan of care. 7. A clinical record review for patient #13 evidenced a RN initial assessment dated 06/22/2023, which indicated the patient had a Penrose drain (a tube that drains fluid away from a wound) to the anal wound site. A review of the plan of care for certification period 06/22/2023-08/20/2023, failed to evidence nursing care orders for the Penrose drain. During an interview on 10/13/2023, at 2:49 PM, the Alternate Clinical Manager indicated the Penrose drain care should have been included on the plan of care. 410 IAC 17-13-1(a)(1)(iii)(viii)(ix) XX. A review of the start of care assessment for Patient #3, dated 9/27/2023, evidenced the patient had a nephrostomy tube (a tube that drains the kidney). A review of the plan of care for certification period 9/27/2023 to 11/25/2023 failed to evidence nephrostomy tube care and drainage bag management. During an interview on 10/13/2023 at 11:20 AM, the alternate clinical manager indicated the plan of care should contain care of the nephrostomy tube including site care, assessing for signs/symptoms of infection, and how often to empty and change the drainage bag. XX. A review of the plan of care for Patient #4, certification period 10/4/2023 to 12/3/2023, evidenced the following order: “Skilled nurse to perform / instruct patient / caregiver procedure of wound care to right great toe 1X/week [one time a week]. Caregiver to provide wound care all other days…”. A review of the plan of care failed to evidence frequency of the patient’s wound care. During an interview on 10/13/2023 at 11:37 AM, the clinical manager indicated wound care orders should include frequency of the care. A review of the skilled nurse admission assessment dated 10/4/2023 indicated the patient was an insulin-dependent diabetic and the caregiver was performing glucose monitoring per physician orders. A review of the plan of care failed to evidence who was monitoring the patient’s glucose and how frequently it was being checked. A review of the physical therapy initial evaluation dated 10/5/2023 indicated the patient was wearing a brace to the right foot. A review of the plan of care failed to evidence the foot brace. During an interview on 10/13/2023 at 11:40 AM, the alternate clinical manager indicated the frequency of blood glucose checks and who was monitoring the glucose should be included in the plan of care. During an interview on 10/13/2023 at 11:47 AM, the clinical manager indicated an order for the foot brace as well as instructions for its use should be included in the plan of care. XX. During a home visit with RN (Registered Nurse) 2 on 10/11/2023 at 10:03 AM, a clear transparent dressing was observed on Patient #6’s right hip surgical incision. A review of the plan of care for Patient #6, certification period 9/27/2023 to 11/25/2023 evidenced the following wound care order: “Skilled nurse to instruct client / caregiver to right hip / upper buttocks suture line daily. Cleanse with soap and water and pat dry. Skilled nurse to assess for skin breakdown. Leave dressing in place … Instruct patient / caregiver … proper disposal of dressings. Caregiver to perform wound care in absence of skilled nurse.” During an interview on 10/11/2023 at 10:13 AM, RN 2 indicated the patient was to keep the dressing in place until it fell off. During an interview on 10/13/2023 at 12:01 PM, the clinical manager indicated the plan of care should indicate the patient’s surgical dressing was to stay in place until their follow up appointment, and there were no dressings the patient / family was to change or dispose. XX. A review of the plan of care for certification period 9/23/2023 to 11/24/2023 indicated Patient #9 had end stage renal failure and was on dialysis. The plan of care failed to evidence where the patient went for dialysis and how frequently it was done. The plan of care evidenced the following goals: Patient / caregiver will understand and demonstrate compliance with treatment regimen for hypertension, patient / caregiver will understand and demonstrate compliance with treatment regimen for heart failure, patient / caregiver will understand and demonstrate compliance with chronic obstructive pulmonary disease, patient / caregiver will demonstrate compliance with treatment regiment of chronic renal failure, and patient / caregiver will demonstrate understand and demonstrate compliance with treatment regimen for diabetes. During an interview on 10/13/2023 at 2:58 PM, the clinical manager indicated the plan of care for a patient on dialysis should include the schedule and the where the patient went for dialysis. The clinical manager indicated the goals on the plan of care should be individualized with measurable outcomes.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to conform to the physician orders in 1 of 1 home visits with a physical therapist (Patient #1). Findings include: A record review evidenced an agency policy revised on 12/01/2021, titled, “Plan of Care,” indicated each patient had an individualized plan of care developed to integrate findings in the comprehensive assessment to address patient problems, needs and goals. The policy indicated the patient would be monitored for response to treatment. A record review evidenced an agency policy revised on 10/01/2023, titled, “The Role of the Physician,” which indicated the agency’s responsibility to the physician would be to notify the physician of significant changes. A clinical record review for patient #1 evidenced a registered nurse (RN) initial assessment dated 09/19/2023, which indicated Patient required daily weights due to congestive heart failure (heart muscle unable to pump sufficient blood and oxygen to the body), and Patient’s current weight was 240 pounds (lbs.). A review evidenced a plan of care for the certification period 09/19/2023-11/17/2023, which indicated a skilled nurse order to obtain weight every visit and notify the RN/physician of weight gain or loss of 2 lbs. overnight or 5 lbs. in a week. A review of a skilled nursing note dated 09/26/2023, indicated Patient’s weight at 233.6 pounds, and a skilled nursing note dated 10/04/2023, which indicated the patient’s weight at 225.8 lbs. The documentation failed to evidence the the RN/physician was notified of the weight loss of 6.4 lbs. from 09/19/2023 to 09/26/2023 and the weight loss of 7.8 lbs. from 09/26/2023 to 10/04/2023. During an interview on 10/13/2023, at 12:19 PM, the Clinical Manager indicated the nurse should have notified the physician of the weight loss being outside of the parameters set on the 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 record review and interview, the agency failed to ensure the services and treatments were provided only as ordered by a physician in 2 of 3 records reviewed with a home visit by a skilled nurse. (Patient #3, 5) The findings include: A clinical record review on 10/11/2023, for Patient #5, evidenced a document from Entity 1 titled “Referral Form” dated 9/15/2023, which indicated the patient’s diagnoses included, but were not limited to, a wound to the left foot with gangrene (dead tissue caused by infection or loss of blood flow). Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 9/22/2023-11/20/2023, indicated the skilled nurse was to perform wound care to the left foot 1 time per week, but the plan of care failed to include what was the wound care. During an observation at the home of Patient #5 on 10/11/2023, at 12:22 PM, Patient #5 requested Licensed Practical Nurse (LPN) 1 apply lotion from a bottle labeled Ammonium Lactate (a medication used to treat dry, scaly skin) to both feet and legs. LPN 1 indicated there was no order for the application of Ammonium Lactate to the legs and feet. At 12:27 PM, a black, dry, scabbed area the size of a quarter was observed on the top of the left foot with a yellow, dry, scaly surrounding area the size of the palm of the hand. At 12:41 PM, LPN 1 was observed calling the physician’s office and spoke to the physician’s nurse to requesting an order for the Ammonium Lactate per patient’s request. LPN 1 was not observed talking to the physician to receive an order. At 12:50 PM, LPN 1 was observed applying Ammonium Lactate to the patient’s lower legs and feet including the wound to the left foot. During an interview on 10/11/2023, at 1:02 PM, LPN 1 indicated she did not get an order for the doctor but left a message for the physician with the nurse to obtain an order for Ammonium Lactate and indicated there was not a wound care order for the wound to the left foot but was only to monitor the wound. During an interview on 10/13/2023, at 2:33 PM, the Clinical Manager indicated the agency had not yet received an order for wound care to the left foot from the physician and were to just monitor the wound. 410 IAC 17-13-1(a) XX. A review of the start of care assessment for Patient #3, dated 9/27/2023, evidenced the patient had a nephrostomy tube (a tube that drains the kidney) and the nurse instructed a family member on how to change the dressing. A clinical record review failed to evidence any orders for nephrostomy tube dressing changes. A review of a skilled nurse phone visit note dated 9/30/2023 evidenced the nurse instructed the patient to take Tylenol for pain. A clinical record review failed to evidence an order for Tylenol. During an interview on 10/10/2023 at 3:31 PM, the alternate clinical manager indicated the nurse should follow physician orders for performing and teaching wound care. During an interview on 10/13/2023 at 11:21 AM, the clinical manager indicated the nurse should instruct on wound care and medications only as ordered by the physician.

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 promptly alert the physician to changes in the patient's condition in 3 of 9 active patient records reviewed (Patients #3, 6, 9). The findings include: 1. A review of an agency policy titled, "Coordination of Care, from Admit to Discharge", revised 9/1/2023, indicated the physician should be notified if a change occurs in the patient's condition or response to treatment. 2. A review of a skilled nurse phone visit by the alternate clinical manager dated 9/30/2023 evidenced Patient #3 complained of pain rating 8 out of 10 at the nephrostomy tube (a tube that drains the kidney) site. A review of a skilled nurse phone visit by the alternate clinical manager dated 10/1/2023 evidenced the patient continued to have pain at the nephrostomy tube site, rated 7 out of 10. A clinical record review failed to evidence the alternate clinical manager notified the physician of the patient’s pain. During an interview on 10/13/2023 at 11:22 AM, the clinical manager indicated the nurse should have notified the physician of a patient’s pain rating greater than 6 and documented that communication in the patient’s record. 3. A review of a physical therapy note dated 10/3/2023 evidenced Patient #6 was not compliant with their medication regimen because they didn’t like taking pills. A clinical record review failed to evidence the physician was notified of the patient’s non-compliance. During an interview on 10/13/2023 at 12:06 PM, the clinical manager indicated the clinician should coordinate with the nurse and the physician should be notified if a patient is not compliant with medications. 4. A review of OT (occupational therapist) 1’s visit note dated 9/28/2023 (Thursday) indicated Patient #9’s pill box which had been filled by the nurse on 9/26/2023 (Tuesday), was found empty except for Sunday’s medications. The note indicated OT 1 instructed the patient not to take extra medications, but failed to evidence physician notification of the incident. A review of OT 1’s visit note dated 10/5/2023 indicated the patient was not taking medications from the planner filled by the nurse, but was taking medications from bottles instead because they did not trust the last person who filled the planner. The note indicated OT 1 notified RN (Registered Nurse) 1 of the incident. A clinical record review failed to evidence the physician was notified of the incident. A review of LPN (licensed practical nurse) 3’s visit note dated 10/10/2023 indicated her review of the medication planner evidenced the patient was not taking their nighttime medications. A clinical record review failed to evidence the physician was notified. A review of LPN 3’s visit note dated 10/3/2023 indicated the patient had a new bruise to the right eye. A clinical record review failed to evidence the physician was notified. A review of a skilled nurse visit note dated 10/3/2023 evidenced the patient’s weight was 103 pounds. A skilled nurse visit note dated 10/10/2023 evidenced the patient's weight was 113 pounds. A clinical record review failed to evidence the physician was notified of the weight gain of 10 pounds in one week. During an interview on 10/13/2023 at 3:50 PM, the clinical manager indicated the physician should have been notified within 24 hours about the medication errors, new bruise, and 10 pound weight gain in one week. 410 IAC 17-13-1(a)(2)

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 plan of care in 1 of 1 home visit with a licensed practical nurse. (Patient #5) The findings include: A clinical record review on 10/11/2023, for Patient #5, evidenced an agency document titled “Visit Note Report” completed by the occupational therapist and dated 10/9/2023, which indicated the patient had 2 new medications: Bumetanide (a medication used to remove excess fluid from the body) and Potassium Chloride (a mineral supplement). Review of an agency document titled “Home Health Updated Plan of Care Report” dated 10/11/2023, failed to evidence Bumetanide and Potassium Chloride in the patient’s plan of care. During an interview on 10/11/2023, at 3:37 PM, the Clinical Manager indicated the plan of care could not be updated with the new medication orders because the plan of care was just approved on 10/10/2023 and no new orders could be updated until the plan of care was approved.

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 record review and interview, the agency failed to coordinate care in 1 of 1 patient records reviewed on dialysis (Patient #9). The findings include: A review of an agency policy titled, "Coordination of Care, from Admit to Discharge", revised 9/1/2023, indicated when a patient receives services from an outside organization, the agency will coordinate care to ensure the patient's needs are being met and any changes in patient condition are communicated. A review of the plan of care for certification period 9/23/2023 to 11/24/2023 indicated Patient #9 had end stage renal failure and was on dialysis. A review of the patient’s clinical record failed to evidence care was coordinated with the dialysis center. During an interview on 10/13/2023 at 3:09 PM the clinical manager indicated the agency should contact the patient’s dialysis center to coordinate patient care and document this communication in a coordination note. 410 IAC 17-12-2(h)

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency performance improvement activities failed to track adverse patient events in 2 of 2 clinical records reviewed with a patient fall (Patient #2, 9). Findings include: 1. A record review evidenced an agency policy revised on 04/06/2023, titled, “Quality Assessment and Performance Improvement (QAPI) Plan,” which indicated the home health agency collected data that was used to monitor the effectiveness and safety of services and quality of care that may include program data from incident report logs. 2. A record review evidenced an agency policy revised on 10/01/2023, titled, “Patient Fall Reduction Program,” which indicated all patients falls are entered as an occurrence in the online reporting system and the data would be used for tracking/trending and evaluation of the program effectiveness. 3. A clinical record review for patient #2, evidenced agency coordination notes dated 06/16/2023 and 07/31/2023, which indicated the patient fell. A review of the agency’s fall quality improvement event reports printed on 10/06/2023, failed to evidence documentation of the patient’s falls. During an interview on 10/11/2023, at 4:09 PM, the Clinical Manager indicated the falls should have been documented on the quality improvement event report for QAPI monitoring. 410 IAC 17-12-2(a) XX. A review of a coordination note dated 10/5/2023 evidenced Patient #9 fell in their home on 10/2/2023. A review of the agency’s fall log from 4/1/2023 to 10/11/2023 failed to evidence an entry for Patient #9. A review of OT (occupational therapist) 1’s visit note dated 9/28/2023 (Thursday) indicated Patient #9’s pill box which had been filled by the nurse on 9/26/2023 (Tuesday), was found empty except for Sunday’s medications. The note indicated OT 1 instructed the patient not to take extra medications. A review of the agency’s incident log from 4/1/2023 to 10/11/2023 failed to evidence an entry for Patient #9. During an interview on 10/13/2023 at 3:40 PM, the clinical manager indicated an incident report should be made for all medication errors and reported falls should be included in the fall log.

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 prepare complete clinical notes in 3 of 8 clinical records reviewed with a skilled nurse (Patient #3, 8, 9). Findings include: 1. A record review evidenced an agency policy revised on 06/01/2023, titled, “Patient Assessment, Initial and Reassessment,” which indicated upon admission and reassessments the clinician would perform assessment activities to include pertinent physical findings. 2. A clinical record review for patient #8, evidenced a resumption of care assessment dated 09/15/2023, which indicated the patient had a g-tube (tube to the stomach to provide nutrition/medications) and a pleurx drain (tube in chest to drain fluid surrounding lungs). A review of the resumption of care assessment failed to evidence documentation of assessment of the g-tube or pleurx drain site. During an interview on 10/13/2023, at 12:37 PM, the Clinical Manager indicated the assessment for the g-tube and pleurx drain site should have included documentation of the surrounding skin assessment and assessed for any signs and symptoms of infection. 410 IAC 17-14-1(a)(1)(E)-RN XX. Observation of a home visit with RN (Registered Nurse) 1 on 10/10/2023 at 12:30 PM evidenced Patient #3 had a nephrostomy tube (a tube that drains the kidney) connected to a drainage collection bag. During the visit, the patient exposed their left upper chest where a band aid was observed and indicated they had a port-a-cath (an implanted device that connects to a vein) that had been used for their recent blood draw. A review of the start of care assessment for Patient #3 on 9/27/2023 evidenced the patient had a nephrostomy tube on their right side, but failed to evidence an assessment of the site, presence of a drainage bag, and assessment of the urine. The assessment failed to include the port-a-cath. During an interview on 10/10/2023 at 1:07 PM, RN 1 indicated the patient’s clinical record failed to evidence the patient had a port-a-cath and she did not know the patient had one until this visit. RN 1 indicated the patient had the same nephrostomy tube connected to the drainage bag since start of care. During an interview on 10/10/2023 at 3:45 PM, the alternate clinical manager indicated the nurse should include the location and appearance of the insertion site of the nephrostomy tube, if there is a dressing, and an assessment of the urine. During an interview on 10/13/2023 at 11:27 AM, the clinical manager indicated the nurse should document an assessment of the port-a-cath site at each visit. A review of a skilled nurse phone visit by the alternate clinical manager dated 9/30/2023 evidenced Patient #3 complained of pain rating 8 out of 10 at the nephrostomy tube (a tube that drains the kidney) site. In the same note, the alternate clinical manager indicated the following goals were met: the patient verbalizes adequate pain control, patient verbalizes decreased pain level as a result of pharmacologic pain control regimen, and patient verbalizes adequate pain control and increased ability to complete activities without complaints of pain. During an interview on 10/13/2023 at 1:06 PM, the alternate clinical manager indicated the goals related to pain control should not be documented as “goals met” until the patient’s pain stayed within their goal level for one to two weeks. XX. A review of the plan of care for certification period 10/4/2023 to 12/3/2023 evidenced Patient #4 had a wound to the right great toe. In their initial evaluation dated 10/9/2023, Occupational Therapist 1 indicated the patient had an amputation on the right foot. During an interview on 10/13/2023 at 11:54 AM, the clinical manager indicated the patient had one wound, on the right great toe, and did not have an amputation. XX. A clinical record review of a skilled nurse visit note dated 10/5/2023 evidenced a narrative which indicated the patient was to apply a skin barrier. A clinical record review failed to evidence any order for a skin barrier. During an interview on 10/13/2023 at 12:10 PM, the clinical manager indicated the patient did not have an order for a skin barrier, and the nurse may have documented that in error. XX. A review of the nurse’s initial assessment dated 9/26/2023 evidenced Patient #9 was on dialysis and had a fistula (a surgically created place to connect to dialysis machines) to their left upper arm. A review of skilled nurse visit notes dated 10/3/2023 and 10/10/2023 indicated the patient had no identified genitourinary (related to the urinary system and genitals) problems. The notes failed to evidence the dialysis fistula. A review of a skilled nurse visit note dated 10/3/2023 indicated LPN (licensed practical nurse) 3 educated the patient / caregiver about what is INR (a blood test used for dosing Coumadin, a blood thinner), target range of INR, and medications that can affect INR results. A clinical record review failed to evidence the patient was taking Coumadin. During an interview on 10/13/2023 at 3:14 PM, the clinical manager indicated the nurse should document the patient is on dialysis in the genitourinary assessment and should document an assessment of the dialysis fistula site at each visit. The clinical manager indicated the patient was not taking Coumadin, and did not get INR’s checked.

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 record review and interview, the agency failed to ensure all services were provided in accordance with accepted professional standards of practice in 1 of 1 records reviewed of patients on dialysis (#9). The findings include: A review of the National Kidney Foundation website, www.kidney.org, evidenced an undated patient brochure titled, “HEMODIALYSIS ACCESS What You Need to Know”, which stated, “ … Three different types of access can be placed for hemodialysis. They are called a fistula, a graft, and a catheter … never let anyone … take your blood pressure from this arm….” A review of the nurse’s initial assessment dated 9/26/2023 evidenced Patient #9 was on dialysis and had a fistula (a surgically created place to connect to dialysis machines) to their left upper arm. A review of a visit note dated 9/28/2023 evidenced PT (Physical Therapist) 2 took the patient’s blood pressure in their left arm. A review of a visit note dated 10/5/2023 evidenced OT (Occupational Therapist) 1 took the patient’s blood pressure in their left arm. A review of LPN (Licensed Practical Nurse) 3’s visit note dated 10/3/2023 indicated Patient #9 had a new bruise to the right eye. A clinical record review failed to evidence the nurse investigated the cause of the new bruise. During an interview on 10/13/2023 at 3:18 PM, the clinical manager indicated a clinician should not take a patient’s blood pressure on the same arm as the dialysis fistula. The clinical manager indicated if a new bruise is found on a patient, the nurse should investigate the cause of the bruise and notify the physician of the findings.