Every finding on record at Community Home Health Care Services, LLC

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based record review and interview, the home health agency failed to ensure the needs of their patients were met in 3 of 5 active clinical records reviewed out of a total of 7 clinical records reviewed. (#2, #3, #5) The findings include: 1. An agency policy revised March 2019 and obtained 8/5/2021, titled "Plan of Care-CMS #485 and Physician Orders" stated "... Patients are accepted for treatment on the reasonable expectation that Agency can meet the patient's medical, nursing, rehabilitative needs in his or her place of residence...." 2. An agency document titled "Patient Bill of Rights and Responsibilities" dated January 2020 and obtained 8/5/2-2021, stated " ... Patients have the right: ... Receive all services in the plan of care ... Participate in, be informed about and consent or refuse care in advance of and during treatment, where appropriate, with respect to: Completion of all assessments. The care to be furnished based on the comprehensive assessment. Establishing and revising the plan of care. The disciplines that will furnish the care. The frequency of visits. ... Any changes in the care to be furnished. ... To be informed of: Visit schedule and frequency...." 3. Clinical record review for patient #2, start of care 5/11/2021, evidence a referral from agency A dated 5/10/2021. The referral indicated orders for the patient to receive skilled nursing services to monitor/assess vital signs and physical status. This referral also indicated the patient was to receive occupational and physical therapy 2-3 times per week for 12 weeks. Record review evidenced an agency document "Home Health Certification and Plan of Care" for certification period 5/11/2021 - 7/9/2021, signed by PT (physical therapist) D and dated 6/2/2021. This document had a subsection titled "Orders for Discipline and Treatment," which stated, "PT 2xw x 9wks [twice a week for nine weeks] and HMKR [homemaker] 4xwk x 9wks [four times a week for nine weeks] ... Additional risk for hospitalization/ER [emergency room] visit ... Needs assistance taking medications Needs assistance with ADLs [activities of daily living]. This plan of care failed to evidence the orders for a skilled nurse or occupational therapist. Clinical record review evidenced an agency document titled "Start of Care (D1) dated 5/11/2021, and electronically signed by PT D. This document evidenced patient #2 needed assistance with taking medications, needed assistance with ADLs, had limited motion of left leg, required assistance dressing lower body and putting on shoes, was a minimum assist with getting out of bed, sitting to standing, in and out of a chair, getting on and off toilet, and was a moderate assist with bathing, needed assistance with taking medications, needed someone else to administer injectable medication, and had difficulty maintaining compliance with medication. Clinical record review failed to evidence the patient's needs were met by the agency. During an interview on 8/6/2021 at 10:25 AM, the clinical manager was queried as to why the patient was not receiving skilled nursing and occupational therapy, she indicated she was confident if those services were needed they would have been ordered. She indicated physicians often do not know the patients well and order services, when they go to assess the patient it is not needed. She indicated she was not comfortable answering whether she thought the patient could benefit from occupational therapy since she does not know this patient. 4. Record review on 8/3/2021 for patient #5, start of care 6/25/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021. The patient had a primary diagnosis of venous insufficiency (veins do not pump blood back to the heart sufficiently). This document had a subsection titled " Orders for Discipline and Treatment," which stated, " Services for PT 1W1 [once a week for one week] 2W8 [twice a week for 8 weeks] ... Additional risk for hospitalization/ER visit ... Needs assistance with ADLs [activities of daily living]. This document failed to include orders for physical therapy services as requested by the physician. Record review evidenced a prescription form with orders from Physician D for Physical and Occupational Therapy to evaluate and treat. Clinical record review failed to evidence there was an occupational therapy evaluation done for patient #5. During an interview on 8/6/2021 at 11:38 AM, the clinical manager indicated sometimes they have trouble staffing occupational therapy, because there was only one company they can use for occupational therapy in the area. 5. Record review on 08/03/2021 for patient #3, start of care 03/19/2021, evidenced patient #3 received 2 skilled nurse visits on 06/14/2021 and 07/11/2021. Patient #3 did not receive skilled nurse visits the weeks of 05/23/2021, 05/30/2021, 06/06/2021, 06/20/2021, 06/27/2021, and 07/04/2021. The agency failed to meet the patient's needs for nursing services. 17-14-1(a)(1)(B)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to review all medications the patient was currently taking in order to identify any potential adverse effects and drug reactions in 5 of 5 active clinical records reviewed, out of a total of 7 records reviewed (#1, #2, #3, #4, #5) The findings include: 1. An agency policy revised March 2018 and obtained 8/5/2021, titled "Medication Reconciliation" stated "The agency will reconcile the patient's medication at the time of admission and on an ongoing basis in order to identify any potential adverse effects and drug interactions, including ineffective drug therapy, significant interactions, duplicate drug therapy and non compliance with drug therapy ... At the time of admission, the admitting RN [registered nurse] PT [physical therapist], or SPL [speech language pathologist] will create and document a complete list of medications that the patient is taking at home, including dose, strength, route and frequency. Any concern or discrepancies will be reconciled by a RN with the patient's physician. Discrepancies include duplications, omissions, changes, contraindications, and/or unclear information ... Medications ordered while the patient is receiving care will be compared to the medication list profile. The medication list/profile will be updated with each new or changed medication...." 2. Clinical record review on 8/3/2021 for patient #1, start of care 9/18/2020, certification period 5/16/2021 - 7/14/2021, and a primary diagnosis of primary oseoarthritis (degeneration of joint cartilage and the underlying bone), evidenced an agency document which indicated the patient medications are, but were not limited to, Aspirin, Atenolol (lowers blood pressure), Atorvastatin (lowers cholesterol), Furosemide (diuretic to treat fluid retention), lasix (diuretic to treat fluid retention), Lisinopril (lowers blood pressure), Meloxicam (used for pain), Omeprazole (proton pump inhibitor for the treatment of reflux), Pantoprazole (proton pump inhibitor for the treatment of reflux), and Potassium chloride The agency failed to ensure there was no duplicate drug therapies on the patient's plan of care. During an interview on 8/5/2021 at 3:52 PM, the clinical manager indicated the staff should be checking medications on admission, weekly visit and at the recertifications. She indicated she will have to check with the nurse to see why the duplicated medications are on the plan of care. 3. Clinical record review on 8/5/2021 for patient #2, start of care 5/11/2021, and a primary diagnosis of Hemiplegia from a CVA affecting the right dominate side (paralysis of the right side after a stroke), evidenced an agency document titled "Start of Care (D1)", dated 5/11/2021, and electronically signed by PT (Physical Therapist) D. This documented evidenced possible drug interactions with aspirin (for circulation) and prednisone (steroid medication), oxybutynin (bladder) and potassium (supplement). This document failed to evidence a registered nurse reconciled the medications. Record review evidenced a referral from Agency A dated 5/10/2021. This document evidenced patient medications including, but not limited to, Calcium (supplement), pioglitazone (for high blood sugar), semaglutide (for high blood sugar), and insulin (for high blood sugar). These medications failed to be included on the patient's plan of care. During an interview on 8/6/2021 at 10:03 AM, the clinical manager indicated all medications and potential interactions are reconciled by the nurse. She indicated the nurse would have called the physician and made sure all of the medications were correct, but there was no good place to document the nurse did this. 4. Clinical record review on 8/4/2021 for patient #4, start of care 3/19/2021, certification period 7/17/2021 - 9/14/2021, primary diagnosis of a stage 4 pressure ulcer to the right buttock (sore that goes through the layers of skin to the bone), evidenced an agency document which indicated the patient medications are, but were not limited to, Azelastine-Fluticasone (for allergies), Bactrim DS (for infection), Gabepentin (for nerve pain), Pantoprazole (for reflux), Singular (for inflammatory disease of the lungs), tamulosin (for enlarge prostate), tizanidine (for muscle spasms) and tramadol (for pain). All of these medications listed a start date as 3/9/2021. Patient #4 was not currently on any antibiotics. The agency failed to review all medications to ensure only medications currently being taken remained on the plan of care. During a home visit on 8/5/2021 at 10:24 AM, patient #4 indicated he has not been on any antibiotics since March of this year. During an interview on 8/6/2021 at 3:31 PM, the clinical manager indicated medications should be reconciled every 60 days or as needed for changes. 5. Clinical record review on 8/4/2021 for patient #5, start of care 9/25/2020, certification period 3/24/2021 - 5/22/2021, primary diagnosis of Venous Insufficiency (vein in legs do not allow the blood to flow back to the heart appropriately), evidenced an agency document which indicated the patient's medications are, but were not limited to, Amoxicillin/ClavK (medication to treat infection), Tylenol (for pain relief) Spirolactone, Aspirin (for circulation), Vitamin C (supplement) Zinc (supplement), melatonin (for sleep), tramadol (for pain), Odansetron (for nausea), certitizine (for allergies), vitamin D3 (supplement) and Flomax (for urinary retention). The agency failed to ensure the patient's current medications were on the plan of care. During a phone interview on 8/4/2021 at 2:36 PM, Person C indicated her husband has not been on antibiotics since 2020. When queried if he was still taking the Amoxicillin/Clav K she indicated he had not been on the antibiotic since September. He was given a course of the medication for a possible infection in his knee. During an interview on 8/6/2021 at 12:24 PM, the clinical manager indicated medications should be assessed weekly and also on the recertifications. 6. Clinical record review on 08/03/2021 for patient #3, start of care 03/19/2021, evidenced two agency documents titled "Home Health Certification and Plan of Care" for certification periods 05/18/2021 - 0717/2021 and 07/17/2021 - 09/14/2021. These documents each contained a subsection titled "10. Medications: Dose/Frequency/Route (N)ew (C)hanged (D)iscontinued" which stated "... Tylenol (a drug used for pain relief) 325MG (milligrams) / 2 tablets / 2 times daily am, pm / Oral / Instructions: Not to exceed 3000 MG in a 24 hour period / Start Date: 03/19/2021." The documents also contained a subsection titled "17. Allergies" which stated "... Ibuprofen & Acetaminophen (both drugs taken for pain relief) ...." The agency failed to ensure the patient's current medications were reconciled. During an interview on 08/06/2021 at 10:58 AM, employee A indicated employee B normally reconciled medication lists within 24 hours. 17-14-1(a)(1)(B)

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 provide services and treatments only as ordered by a physician in 2 of 5 records reviewed. (#3, #4) The findings include 1. An agency document revised March 2018 and obtained on 8/5/2021 titled "Supply Maintenance" stated, "All medical supplies, especially sterile items, will be properly stored in a clean, dry area and handled in a sanitary manner protected from potential contamination as indicated by the manufacturer. Supply packaging will remain intact while stored. If outer package is damaged or open, supply will be removed and discarded...." 2. On 08/05/21 from 9:37 AM to 10:20 AM, patient #4's home visit was conducted with the registered nurse. During the patient's wound care, RN [registered nurse] C was observed to pull down patient #4's adult diaper. RN C removed his gloves and placed them in a plastic bag on the floor and performed hand hygiene with alcohol hand rub. RN C pulled new gloves from his bag and put them on. RN C then rifled through an open cardboard box on the patient's couch for wound dressing material. RN C took a sealed package of gauze, opened it, then laid the contents on the outside of the packaging. RN C then reached into a sandwich baggie - also taken from the box of supplies - and removed Calcium Alginate (a highly absorbent wound dressing that forms a gel-like covering over a wound, helping to maintain a moist wound healing environment, promote the healing process, and minimize bleeding). RN C placed the Calcium Alginate on top of the gauze. RN C cleaned the wound with sterile saline and the gauze, removed his gloves, placed the gloves in the bag on the floor, performed hand hygiene, and donned new gloves. RN C then opened a new package of Allevyn (a foam dressing designed to provide an optimal moist environment), keeping it inside the open packaging, and placed the exposed Calcium Alginate inside with the Allevyn. RN C removed his gloves and put them in the plastic bag on the floor, performed hand hygiene, looked through his bag for tape, and asked patient #4 if he had any tape. Patient #4 indicated where a small roll of tape was. RN C performed hand hygiene, donned new gloves, and placed the Calcium Alginate directly onto the wound with the Allevyn over it. RN C used tape to secure the dressing onto patient #4's skin. The agency failed to ensure RN C followed physician wound care orders for Collagen Promogran (a dressing that supports a moist wound healing environment, encourages the deposition of new collagen fibers, supports new tissue growth, and new connective tissue formation in the wound bed). 3. Clinical record review on 08/3/2021 for patient #3, start of care 03/19/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 05/18/2021 - 07/16/2021. This document stated "... Services for Physical Therapist: - Effective on 5/18/2021: PT: 2W4 05/18/2021 - 06/12/2021 ... Effective on 06/13/2021: PT: 1W5 06/13/2021 - 07/16/2021 ... Services for Skilled Nurse: - Effective on 05/18/2021: SN: 1W9 05/18/2021 - 07/16/2021...." The document does not evidence orders for a home health aide. Patient #3 received 3 Home Health Aide visits on 05/20/2021, 06/02/2021, and 07/07/21. The agency failed to ensure the home health aide had written orders for the patient. 4. An agency document titled "Care Planning Process" dated March 2018 stated " ...The patient care plan for the Home Health Aide will be: Home Health Aide assignment sheet: developed by a Registered Nurse (Physical Therapist or Speech Language Pathologist, if nursing not ordered) prior to Home Health Aide rendering care. Reviewed at least every 14 days during supervisory visit and based on patient's health status and environment.... The assignment sheet/plan of care will be communicated to the Home Health Aide by the appropriate discipline...." 5. During an interview on 8/6/2021 at 10:00 AM, employee A indicated patient #3 has always had home health aide services. 17-13-1(a)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the administrator failed to ensure the day to day operations of the home health agency. The findings include: Review of an agency document revised March 2019 and obtained on 8/4/2021, titled "Job Description Administrator" stated "The administrator endure quality and safe delivery of home health care services; coordinates services that reflect the Agency' philosophy and standards of care: plans, develops, implements and evaluates Agency services, programs and activities and responsible to all day-to-day operations of the Agency ...." The administrator failed to ensure the agency met all of their patient's needs. Please see tag G0534. The administrator failed to ensure agency patients received all services ordered in the plan of care. Please see tag G0536. The administrator failed to ensure the plan of care for agency patients was followed, individualized and established by a primary care physician. Please see tag G0572. The administrator failed to ensure the plan of care contained all required elements. Please see tag G0574. The administrator failed to ensure the plan of care was revised and updated to reflect the patients current status. Please see G0580. The administrator failed to ensure the primary care physician was promptly alerted to changes in the patient's condition. Please see tag G0590. The administrator failed to ensure there was coordination of care amongst all agency disciplines and with outside healthcare entities who serviced agency patients. Please see tag G0606. The administrator failed to ensure there was a written visit schedule in all patient's homes. Please see tag G0614. The administrator failed to ensure all home health agency staff followed standard precautions to ensure the prevention and transmission of infectious and communicable diseases. Please see tag G0682. The administrator failed to ensure all home health aide care plans were completed by a skilled professional and included task frequencies. Please see tag G0798. The administrator failed to ensure failed to ensure the name administrator and clinical manager was disclosed to the state agency. Please see tag G0856. The administrator failed to ensure all clinical notes were clear, complete and appropriately authenticated. Please see tag G1024. 17-12-1( c)(1)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all clinical records were clear, complete and appropriately authenticated in 5 of 7 clinical records reviewed. (#1, #2, #3, #4, #5) The findings include: 1. An agency document titled "Medical Record Entries and Authentication" dated March 2018 stated, "Policy: All medical record entries will be dated and authenticated. Only authorized individuals make entries in the patient's record. ... All entries in the medical records will be authenticated by staff signature and title. By authenticating entries in the patient's record, staff is validating the correctness of the information. Signatures are legible and legal. ... If automated clinical record system is used, authentication includes a signature and title...." 2. Clinical record review on 8/3/2021 for patient #1, start of care 9/18/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/16/2021 - 7/14/2021, electronically signed by RN (registered nurse) C. This plan of care failed to evidence the credentials of RN C. Clinical record review evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 7/15/2021 - 9/12/2021. This plan of care failed to evidence a signature of the nurse or the physician who created / approved the document. Clinical record review evidenced agency documents titled "Skilled Visit Note" dated 7/8/2021, 7/28/2021, and electronically signed by RN C. These documents failed to evidence the credentials of RN C. Clinical record review evidenced an agency document titled "Supplemental Provider Order" electronically signed by RN C and unsigned by the physician. This document failed to evidence the physician's signature and the credentials of RN C. During an interview on 8/5/2021 at 3:50 PM, the clinical manager indicated the staff credentials should automatically be in the system, but whoever entered RN C into the system must not have added the credentials to RN C's name. 3. Clinical record review on 8/4/2021 for patient #2, start of care 5/11/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/11/2021 - 7/9/2021, electronically signed by PT (physical therapist) D. This plan of care failed to evidence the credentials of PT D. Clinical record review evidenced agency documents titled "Therapy Visit Note" dated 5/19/2021, 5/20/2021, 5/28/2021, 6/3/2021, 6/4/2021, 6/7/2021, 6/18/2021, 6/22/2021, 6/25/2021, 6/28/2021, and electronically signed by PTA (physical therapy assistant) E. This document failed to evidence PTA E's credentials. Clinical record review evidenced an agency document titled "Missed Visit Note" dated 6/29/2021, and electronically signed by PTA E. This document failed to evidence PTA E's credentials. During an interview on 8/6/2021 at 11:12 AM, the clinical manager indicated PTA E was entered into the system without credentials and they would need to fix that in the system. 4. Clinical record review on 8/3/2021 for patient #4, start of care 3/19/2021, evidenced an agency document titled "Recertification (D1)" signed by RN C and dated 7/19/21. This document failed to have the credentials of RN C. Clinical record review evidenced an agency document titled "Supplemental Provider Order" dated 7/19/2021, and signed by RN C. This order indicated patient #4 was to receive skilled nurse services twice a week for nine weeks. This document failed to evidence RN C's credentials. Clinical record review evidenced an agency document titled "Fall Risk Assessment" dated 7/19/2021, and signed by RN C. This document failed to evidence RN C's credentials. Clinical record review evidenced an agency document titled "Braden Scale" [predicts pressure ulcer risk] dated 7/19/2021, and signed by RN C. This document failed to evidence RN C's credentials. During an interview on 8/6/2021 at 3:24 PM, the clinical manager stated, "We will need to make sure the credentials get in there (the new electronic system)." 5. Clinical record review on 8/4/2021 for patient #5, start of care 6/25/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021, electronically signed by PT D. This plan of care failed to evidence the credentials of PT D. Clinical record review evidenced an agency document titled "Braden Scale". This document failed to be dated or signed by the clinician who created the document. Record review evidenced agency documents titled "Therapy Visit Note" dated 6/30/2021, 7/1/2021, 7/6/2021, 7/19/2021, and 7/22/2021 and signed by PTA E. These documents failed to evidence PTA E's credentials During an interview on 8/6/2021 at 12:04 PM the clinical manager indicated a box pops up with the staffs name and they click on that to sign. She indicated they need to go back through and add the credentials of the staff to the program. 6. Clinical record review on 08/03/2021 for patient #3, start of care 03/19/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 07/17/2021 - 09/14/2021. This plan of care had a subsection titled "23. Nurse's Signature and Date of Verbal SOC [start of care] Where Applicable" which evidenced the electronic signature of RN H, the date and time. The agency failed to ensure the credentials for RN H were placed after the name. Clinical record review on 08/06/2021 for patient #3, start of care 03/19/2021, evidenced several agency documents titled "MED-PASS Physical Therapy Evaluation." These documents were dated 05/19/2021, 05/26/2021, 05/28/2021, 06/01/2021, 06/03/2021, 06/07/2021, 06/24/2021, 07/01/2021 and 07/09/2021. Each of these documents was signed by PTA E and did not have any credentials at the end of the signature. The agency failed to ensure the patient's record was correctly authenticated. Clinical record review on 08/06/2021 for patient #3, start of care 03/19/2021, evidenced an agency document titled "MED-PASS Recertification (D-1)" dated 05/17/2021. This document was signed by RN C and did not have any credentials at the end of the signature. The agency failed to ensure the patient's record was correctly authenticated. Clinical record review on 08/06/2021 for patient #3, start of care 03/19/2021, evidenced an agency document titled "MED-PASS Physical Therapy Evaluation" dated 06/10/2021. This document was signed by PT N and did not have any credentials at the end of the signature. The agency failed to ensure the patient's record was correctly authenticated. 17-15-1(a)(7)

This visit was a Complaint and State Re-licensure survey. This survey was conducted from 2/9/2021 - 2/18/2021. Complaint: IN00343515 - unsubstantiated- with unrelated findings IN00244205 - unsubstantiated- with unrelated findings Facility ID: 002684 Provider ID: 157533 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this survey Home Health Services of NWI was found to not meet 1 Condition of Participation at 42CFR 484.102 Organization and Administration of Services Home Health Services of Northwest Indiana is precluded from providing its own home health aide training and competency evaluation for a period of two years which began on 2/18/2021 - 2/18/2023 due to being found out of compliance with Condition of Participation 42CFR 484.102 Organization and Administration of Services. Quality Review completed 03/03/2021 Area 1

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure patients received the services ordered in the plan of care in 1 of 2 clinical records reviewed needing only skilled nursing services out of a total of 10 clinical records reviewed. (#7) The findings include: Record review on 2/18/2021 evidenced an agency policy titled "Care Planning Process" revised March 2018. This policy stated, "Policy In order to ensure that care provided is appropriately planned to meet each patient's specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process...." Clinical record review on 2/16/2021 for patient #7, start of care 7/24/2020, evidenced an agency document titled "Plan of Care," for certification period 11/21/2020 to 1/19/2021, signed by the clinical manager. Diagnoses include are but not limited to Hydronephrosis [excess fluid in the kidneys], chronic kidney disease, heart disease and muscle weakness. This document had a section titled "Orders" which stated "Assess vital signs and all body systems ... Clean around suprapubic [area of abdomen below the below the belly button where a hollow tube was placed to drain the bladder] site with soap and water, pat dry. Stoma will be clear of infection this certification period...." Clinical record review on 2/16/2021 for patient #7, evidenced an agency document titled "Nursing Visit Record", dated 1/7/2021, signed by LPN [Licensed Practical Nurse] D. This document had a subsection titled "Vital Signs" which failed to evidence patient #7's blood pressure, pulse and temperature. The skilled nurse failed to follow the medical plan of care. Clinical record review evidenced agency documents titled "Nursing Visit Record", dated 12/30/2020, 1/7/2021, 1/14/2021, 1/20/2021, 1/27/2021, 2/5/2021 and signed by LPN D. These documents failed to evidence LPN D assessed the suprapubic site for signs and symptoms of infection. The skilled nurse failed to follow the medical plan of care. During an interview on 2/18/2021 at 10:14 a.m., the clinical manager indicated the nurse was probably not documenting anything because the site was okay. She indicated she will educate staff on documenting the area of the suprapubic catheter. 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 record review and interview, the agency failed to ensure the individualized plan of care included all treatment orders in 3 of 3 clinical records reviewed needing wound care, out of a total of 10 clinical records reviewed. (#1, #2, #8) These findings include: 1. Record review on 2/18/2021 evidenced an agency policy titled "Care Planning Process" revised March 2018. This policy stated, "Policy In order to ensure that care provided is appropriately planned to meet each patient's specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process ... 1. The patient care plan for skilled nursing will be: Initial care plan will be CMS #485 Plan of Care, which is developed and implemented with the physician, Demonstrates problems (diagnoses), interventions (physician orders) and long range goals ...." 2. Clinical record review on 2/16/2021 for patient #1, start of care 8/15/2020, evidenced an agency document titled "Plan of Care," for certification period 10/14/2020 to 12/12/2020, signed by RN [Registered Nurse] E. Diagnoses include but are not limited to: surgical wound, hypertension [high blood pressure] diabetes type 2 [high blood sugar] and anxiety E. This document had a section titled "Orders," which stated, "Wound Care to right foot wound cleanse with betadine [antiseptic to prevent infection] and normal saline. Betadine dressing placed on wound and coban [self adherent wrap] to hold in place...." Clinical record review on 2/16/2021 for patient #1 evidenced agency documents titled "Nursing Visit Record," dated 10/20/2020, 11/03/2020, 11/06/2020, 11/10/2020, 12/01/2020, 12/04/2020, 12/08/2020, and 12/10/2020, signed by LPN D. These documents failed to evidence wound measurements for patient #1's right foot. During an interview on 2/18/2021 at 11:15 a.m., the clinical manager indicated wounds should be measured on a weekly basis. She indicated she would do additional teaching with the nurse to ensure wounds are measured. 3. Clinical record review on 2/16/2021 for patient #2, start of care 5/15/2020, evidenced an agency document titled "Plan of Care," for certification period 11/11/2020 to 11/9/2021, signed by the clinical manager. Diagnoses include but are not limited to: pressure ulcer [injury to an area due to prolonged pressure] to the left hip, urinary tract infection, cerebral palsy [affecting movement], scoliosis [curvature of the spine], and lordosis [curvature lumbar[lower back] region.. this document had a section titled "Orders", which stated, "Wound Care as follows: Cleanse with normal saline, apply skin prep, collagen, black foam sponge with wound vac." Clinical record review on 2/16/2021 for patient #2 evidenced an agency document titled "Nursing Visit Record" dated 12/19/2020 and signed by LPN D. This documents failed evidence wound measurements for patient #2's left hip. During an interview on 2/18/2021 at 12:20 p.m., the clinical manager indicated wounds should be measured on a weekly basis by the nurse performing wound care. 4. Clinical record review on 2/17/2021 for patient #8, start of care 9/25/2020, evidenced an agency document titled "Plan of Care," for certification period 9/25/2020 to 11/23/2020, signed by RN E. Diagnoses include but are not limited to surgical wound, presence of right artificial knee joint, venous insufficiency [veins do not allow blood back to the heart properly], and cirrhosis of the liver [late stage liver disease]. This document had a section titled "Orders" which stated, "Wound care as follows right knee: Cleanse with normal saline and use skin prep Wound vac to be changed 2XWK [two times per week]." Clinical record review on 2/16/2021 for patient #8 evidenced agency documents titled "Nursing Visit Record," dated 10/2/2020, 10/7/2020, 10/16/2020 and 10/23/2020 and signed by LPN D. These documents failed evidence complete wound measurements for patient #2's right knee. During an interview on 2/18/2021 at 12:05 p.m., the clinical manager indicated wounds should be measured on a weekly basis. She indicated she would do additional teaching with the nurse to ensure wounds are measured. 410 IAC 17-13-1(a)(1)(D)(xiii)

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 ensure the skilled nurse promptly informed the physician of patient assessment findings outside of the patient's normal parameters in 2 of 2 clinical records reviewed of patients receiving only skilled nursing services, out of a total of 10 clinical records reviewed. (#1, #2) The findings include: 1. Record review on 2/18/2021 evidenced an agency policy titled "Coordination of Patient Care," revised March 2019. This policy stated, "Policy Agency staff members regularly communicate to ensure that their efforts are coordinated effectively and ultimately support the objectives outlined in the plan of care. Purpose To ensure quality services are being provided to patients; to provide a mechanism for representatives form various disciplines to discuss patient care in a group meeting: and to determine eligibility for care. Procedure 1. The Agency must: Assure communication with all physicians involved in the plan of care...." 2. Record review on 2/18/2021 evidenced an agency policy titled "Pain Assessment and Reassessment," revised March 2019. This policy stated, "Policy Appropriate Agency staff will assess and reassess patients pain ... 1. Each patient receiving skilled nursing services will have pain assessed initially and on an ongoing basis using established criteria that are consistent with the patients age, condition and ability to understand ... 3. When the patient's pain is not relieved the nurse or therapist will intervene appropriately. Such interventions include: Notification of patient's physician...." 3. Clinical record review of patient #1, start of care 8/15/2020, evidenced an agency document titled "Nursing Visit Record" dated 10/21/2020 and signed by RN [Registered Nurse] S. This document had a subsection titled "SKILLED INTERVENTION / TEACHING / PT[patient]/Cg[caregiver] RESPONSE" which stated, " ... Pain becoming more frequent...." This document failed to evidence the physician was notified of the patients increase in pain frequency. During an interview on 2/18/2021 at 11:15 a.m., the clinical manager indicated the physician should have been notified of the increase in pain frequency but she did not see it documented. 4. Clinical record review on 2/16/2021 for patient #2, start of care 5/15/2020, evidenced an agency document titled "Nursing Visit Record" dated 10/23/2020 signed by RN E. This document had a subsection titled "SKILLED INTERVENTION / TEACHING / PT[patient]/Cg[caregiver] RESPONSE" which stated, "reports the red lumen of the PICC [peripherally inserted central catheter] is clogged. For pt [patient] safety - tape applied to the red lumen with Do not use written on it...." This document failed to evidence the physician was notified the red lumen was clogged on the PICC line. During an interview on 2/18/2021 at 11:15 a.m., the clinical manager indicated she recalled when that happened and the physician was notified of the line being clogged but it must not have been document by the nurse. 410 IAC 17-13-1(a)(2)

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 home health agency failed to ensure they coordinated care with other health care providers that provided care to agency patients in 1 of 2 discharge records reviewed, out of a total of 10 clinical records reviewed. (#9) The findings include: Record review on 2/18/2021 evidenced an agency policy titled "Coordination of Patient Care," revised March 2019. This policy stated, "Policy Agency staff members regularly communicate to ensure that their efforts are coordinated effectively and ultimately support the objectives outlined in the plan of care. Purpose To ensure quality services are being provided to patients; to provide a mechanism for representatives from various disciplines to discuss patient care in a group meeting: and to determine eligibility for care. Procedure 1. The Agency must: Assure communication with all physicians involved in the plan of care ... Integrate orders from all physicians involved in the plan of care to endure the coordination of all services and interventions provided to the patient ... 8. Care will be coordinated with other involved external organizations e.g. home medical equipment providers, infusion therapy/pharmacy companies and community agencies...." Clinical record review on 2/16/2021 for patient #9, start of care 8/18/2017, evidenced an agency document titled "Comprehensive Adult Assessment" signed by RN [Registered Nurse] N and dated 8/18/2017. This document had a subsection titled "Patient History and Diagnoses," Entity B [home health agency] in home for skilled nursing and PT [Physical Therapy]...." Clinical record review on 2/16/2021 for patient #9, evidenced an agency document titled "CARE COORDINATION COMMUNICATION," dated 8/21/2017 which stated, "Spoke with the patient to set up HHA [home health aide] and she wanted to speak with the nurse before someone come [sic] out ... She has a HHA from [Entity B]...." Clinical Record review on 2/16/2021, for patient #9, failed to evidence coordination of care between the home health agency and entity B. During an interview on 2/18/2021 at 11:22 a.m., the clinical manager indicated care is coordinated with other agencies who provide services the patient. The clinical manager checked the chart for coordination of care and was unable to find the documentation. 17-12-2(h)

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure their patients received a written visit schedule in 2 of 4 home visits conducted. (#1, #2) The findings include: 1. Record review on 2/18/2021, evidenced an agency policy titled "PATIENT'S BILL OF RIGHTS/RESPONSIBILITIES AND TRANSFER/DISCHARGE CRITERIA," revised October 2017. This policy stated, "... Patients have the right: ... Participate in, be informed about and consent or refuse care in advance of and during treatment, where appropriate, with respect to: ... The frequency of visits...." 2. Record review on 2/18//2021, evidenced an agency policy titled " Coordination of Patient Care," revised March 2019. This policy stated, "... 9. Agency will coordinate care with the patient by providing a copy of written instructions outlining: Visit schedule, including frequency of visits by Agency personnel and personnel acting on behalf of the Agency, the written visit schedule provided to the patient is consistent with the patient's most current plan of care." 3. Observation of a visit for patient #1, start of care 8/15/2020, on 2/11/2021 at 10:00 a.m., failed to evidence a written visit schedule of services to be provided from the home health agency. During a home visit interview on 2/11/21 at 10:12 a.m., patient #1 indicated he does not have a written home visit schedule in the home. During an interview on 2/18/21 at 10:21 a.m., the clinical manager indicated they are working to ensure all the patients have a written schedule in the home. 4. Observation of a home visit for patient #2, start of care 5/15/2020, on 2/11/2021 at 4:10 p.m., failed to evidence a written visit schedule of services to be provided from the home health agency in a home folder. During a home visit interview for patient #2 on 2/11/21 at 4:26 p.m., person A, family member for patient #2, indicated she did not receive a written home visit schedule from the home health agency. During an interview on 2/18/21 at 12:34 p.m., the clinical manager indicated they are working to ensure all the patients have a written schedule.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all employees practiced standard precautions and followed agency infection control policies and procedures at 1 of 4 home health visits. (#4) The findings include: Record review on 2/18/2021, evidenced an agency policy titled "Exposure Control Plan: OSHA Regulations, " revised March 2018. This policy stated, "... Hand Hygiene is the most important procedure in the prevention of infections. Hand washing will be performed by all staff according to established Hand Hygiene Policy ...." Record review on 2/18/2021, evidenced an agency policy titled "Standard Precautions," revised March 2018. This policy stated, "Policy Blood and body fluid precautions will be followed for all patients. Purpose to prevent transmission of communicable diseases. Procedure ... 2. The principles of Standard Precautions are to be followed by all employees when contacting any such substances or areas. Standard Precautions include the following procedures: all health care workers routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when in contact with blood or other bodily fluids of any patient is anticipated. Gloves will be worn before touching blood and body fluids, mucous membranes or non-intact skin of all patients; for handling items with blood or bodily fluids; and for performing venipuncture and other vascular access procedures. Gloves will be changed and hands washed after contact with each patient ... 3. Hands and other skin surfaces will be washed immediately and thoroughly if contaminated with blood or other bodily fluids...." Record review on 2/18/2021, evidenced an agency policy titled " Hand Hygiene Policy and Compliance Program," revised March 2018. This policy stated, "Policy Hand hygiene will be done by all employees to reduce the transfer of microbes to patients and to prevent the growth of microorganisms on the nails, hands and forearms. Purpose To prevent transfer of germs and transmission of infections to patients and caregivers and to implement a hand hygiene compliance program ... Procedure 1. Indications for staff performing hand hygiene are: before and after direct patient care. Before and after each procedure ... When hands are soiled. After contact with contaminated materials ... 2. All employees are responsible for implementing hand hygiene procedures in an ongoing attempt to prevent and/or contain infectious processes and communicable disease ... Indications for handwashing and hand antisepsis A. Visible dirt , blood or body fluids on hands of health care worker ... After contact with blood, body fluids, mucous membranes, non-intact skin and wound dressings ... Moving from a contaminated patient body site to a clean site during patient care ... Use of gloves: A. Gloves are not a substitute for hand hygiene ... D. Change gloves if moving from contaminated to clean patient site or the environment...." During a home visit on 2/15/2021 at 8:30 a.m., HHA [Home Health Aide] I was observed giving a bed bath to patient #4. HHA I obtained two basins of water from the kitchen sink and brought them to patient #4. HHA I used a washcloth to wash patient #4 face and then washed patient #4's chest, neck and arms. HHA I was observed removing patient #4's soiled pants and undergarments. HHA I used baby wipes to clean patient #4's buttocks. HHA I then put the soiled baby wipes into a zip lock bag and closed the bag. HHA I put patient #4's clean undergarment, pants, and shoes on failing to remove her gloves and wash her hands after cleaning the patient's buttocks and prior to putting on clean clothing and removing the drawsheet from patient #4. During an interview on 2/18/2021 at 2:20 p.m., the clinical manager indicated employees are to wash their hands after any contact with a dirty area. She indicated she would re-educate staff to ensure they are following the agency's policies and procedures.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse provided a complete and appropriate care plan for the home health aide [HHA] in 1 of 1 home visits conducted with a home health aide. (#9) The findings include: Record review on 2/18/2021 evidenced an agency policy titled "Care Planning Process," revised March 2018. This policy stated, " Policy In order to ensure that care provided is appropriately planned to meet each patient's specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process ... 3. The patient care plan for the Home Health Aide will be: Home Health Aide assignment sheet: developed by a Registered Nurse prior to Home Health Aide rendering care ... The Assignment sheet/plan of care will be communicated with the Home Health Aide by the appropriate discipline. The sheet/plan of care will include: Type service/procedure to be provided ... Specific procedure to be performed including amount, frequency, and duration ... Instructions for completion of documentation...." Record review on 2/18/2021 evidenced an agency policy titled "Home Health Aide Documentation," revised March 2018. This policy stated, "Policy The Agency will ensure accurate documentation of home health aide services ... 2. The Clinical Manager or designated RN [Registered Nurse] /Therapist is responsible for reviewing the HHA's [Home Health Aide] charting...." Clinical record review on 2/17/2021 for patient #9, start of care 8/18/2017, evidenced an agency document titled, "Aide/Homemaker Care Plan," signed by RN N and dated 8/18/2017. This document has a subsection titled "Vital Signs," which stated, "Temperature 3 x's/week [three times per week] ... Pulse 3 x's/week Respirations 3 x's/week...." Clinical record review for patient #9 evidenced agency documents titled "Home Health Aide Progress Notes," dated 8/23/2017, 8/26/2017, 8/30/2017 and 9/1/2017 and signed by HHA [home health aide] O. These documents failed to evidence patient #9's temperature, pulse and respiration. Clinical record review for patient #9 evidenced agency documents titled "Home Health Aide Progress Notes," dated 9/6/2017, 9/20/2017, 9/22/2017 and 10/2/2017, 10/4/2017, 10/6/2017, 10/9/2017, 10/11/2017 and 10/13/2017 and signed by HHA P. These documents failed to evidence patient #9's temperature, pulse and respiration. Clinical record review for patient #9 evidenced agency documents titled "Home Health Aide Progress Notes," dated 10/18/2017 and 10/21/2017 and signed by HHA Q. These documents failed to evidence patient #9's temperature, pulse and respiration. During an interview on 2/19/2021 at 11:30 a.m., the clinical manager indicated the nurse who filled out the aide care plan was new and the home health aides do not do vital signs during their visits. She indicated this should never have been on the plan of care. The clinical manager indicated they are using a new documentation system now so this will no longer be an issue. 410 IAC 17-14-1(m)

Officer, a director, agent, managing employee CFR(s): 484.100(a)(2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in §420.20l, §420.202, and §420.206 of this chapter. This ELEMENT is not met as evidenced by: Based on record review and interview the home health agency failed to ensure the name of the new administrator and clinical manager was disclosed to the state agency. The findings include: A review of Indiana Department of Health pre-survey documents on 2/8/2021, evidenced the administrator and clinical manager was RN [Registered Nurse] B. Record review of the agency's handbook on 2/9/2021, evidenced an untitled section on the first page that evidenced RN A as the Administrator. Record review on 2/9/2021, of the employee list received from the administrator evidenced RN A was the current administrator and clinical manager. The home health agency failed to inform the state agency of the administrative changes. During an interview on 2/9/2021 at 10:41 a.m., RN A indicated she was the new clinical manager. She indicated she took over the position in November of 2020. RN A indicated the state should have been notified of the changes and CMS [Center for Medicare and Medicaid Services] knew of the administrative changes. 17-10-1(d)((2)

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation, interview and record review the home health agency failed to ensure the state agency was notified of the facility location change and the change of the facility parent and branch prior to the home health agency making changes to the organization. The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.105 Organization and Administration of Services. A standard citation was also evidenced at this level. Based on observation, interview and record review, the administrator failed to ensure the accuracy of public information, and failed to receive approval from the state agency before changing locations, and swapping of their branch and parent location. The findings include: A review of Indiana Department of Health pre-survey documents on 2/8/2021, evidenced the agency address as 8959 Broadway Merrillville, IN 46410, and evidenced the Clinical Manager was RN [Registered Nurse] B. Upon Arrival to 8959 Broadway Merrillville, IN on 2/9/2021 at 9:20 a.m., a note was observed on the door which stated, "Will be moving today 8/31/2020 to 9800 Connecticut Crown Point IN If you have any questions please contact us at 219-736-9270 Thank you." The name of the agency Home Health Services of NWI had been removed from the glass door, but the outline of the letters were still evident. During an interview on 2/9/2021 at 10:41 a.m., RN A indicated she was the new clinical manager. She indicated she took over the position in November of 2020. She indicated the branch was changed to the 9800 Connecticut Merrillville, IN, location, and the previous branch location at 240 Commerce Michigan City, IN was now the parent location. RN A indicated the state should have been notified of the changes and CMS [Center for Medicare and Medicaid Services] knew of the changes of location and administrative changes. The agency failed to ensure CMS and state agency approval prior to moving and changing the parent and branch locations Clinical record review of the agency's handbook on 2/9/2021, evidenced an untitled section on the first page that evidenced [RN A] as the Administrator and the parent location address as 240 Commerce Square Michigan City, IN 46360. The following page of the handbook evidenced a letter to the patient which was signed [RN B name] administrator. There was a section titled, "PATIENT'S BILL OF RIGHTS/RESPONSIBILITIES AND TRANSFER/DISCHARGE CRITERIA," this section stated, "... Voice concerns related to care, treatment or services and patient safety issues: Please call Agency Director of Clinical Services Administrator/Director of Clinical Services - [name of employee B, RN] 219-879-9300 ... Name of Clinical Manager [RN B] Administrator." There was a section of this handbook titled "Admission Agreement," which stated, "... Call the office at 219-879-9300 between 8:00 a.m., and 4:00 p.m., and ask for the Administrator/Director of Clinical Services [RN B name] ." The handbook evidenced a section titled "REHABILITATION ACT OF 1973 SECTION 504 GRIEVANCE PROCEDURE" which stated, "contact the administrator [RN B name]...." Clinical record review of this document failed to evidence the current administrator and clinical manager of the home health agency. During an interview on 2/9/2021 11:23 am., the administrator indicated she was aware the agency handbook had the incorrect information for the administrator and clinical manager, new books have been ordered and the agency was awaiting delivery. 17-12-1(a)(1)