Every finding on record at Trinity Home Health Services Inc

This visit was for a Federal Complaint survey of a Deemed HHA provider. Survey Dates: July 11 and 12, 2024 Complaint IN1107581 with related and unrelated deficiencies. 12 Month Unduplicated Skilled Admissions: 1605 QR 7/17/24 A2

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 on record review, observation, and interview, the agency failed to ensure assessments accurately reflected the patient’s current medical status in 1 of 4 active records reviewed of patients with wounds (Patient #2). Findings indicate: 1. Review of an agency policy titled “Wound Measurement Program” indicated utilizes the expertise of the Wound Ostomy Continence Nurse Society (WOCN) and wound care measurements should be done weekly to document wound progress. 2. Review of the WOCN recommendations for measuring wounds indicated the depth of a wound would usually be measured by inserting a Q-tip into the deepest part of the wound and determining how well a wound would be healing depends on consistent measurements and if different care team members measure it differently, it would result in inconsistency, errors, and treatment problems with the healing process. 3. Review of the registered nurse (RN) job description indicated the RN is to accurately assess patient’s condition and needs. 4. Review of the clinical record of Patient #2, start of care date 10/16/2023 with diagnosis, but not limited to, cancer of left breast. The wound record report included a baseline assessment of the left chest area cancer lesion completed on 10/16/2023 with wound depth measurement of 0.3 centimeters (cm). During a home visit on 07/12/2024 beginning at 9:00 AM, RN 2 removed the old dressings to a wound to the left chest area and observed a large wound protruding outward from the skin surface. Review of the wound care report for certification period 04/13/2024 – 06/11/2024 included the following depth measurements: on 05/13/2024 RN 2 documented 0.2 cm, on 05/20/2024 licensed practical nurse (LPN) 1 documented 0.1 cm, on 05/27/24 the clinical manager documented 13.0 cm, on 06/03/2024 RN 2 documented 0 cm, and on 06/10/2024 RN 2 documented 5 cm. Documentation failed to evidence an accurate depth measurement of the wound. Review of the wound care report for certification period 06/12/2024 – 08/10/2024 included the following depth measurements: on 06/17/2024 RN 2 documented 0.1 cm, on 06/24/2024 LPN 1 documented 0.1 cm, on 07/01/2024 RN 3 documented 7 cm, and on 07/08/2024 LPN 1 documented 0.1 cm. Documentation failed to evidence a consistent depth measurement of the wound. During an interview on 07/12/2024 at 12:12 PM, when asked how to measure the depth of the wound of Patient #2, RN 2 indicated the wound had changed and used to have a small section at the top of the wound with depth, and today during the home visit there was no open area. During an interview on 07/12/2024 at 2:50 PM, when asked about the depth measurement of 13 cm on 05/27/2024, the clinical manager indicated the wound sometimes had a small open area with depth and that the wound had never been 13 cm in depth, that was a mistake. During an interview on 07/12/2024 at 2:56 PM, when asked how to measure the depth of the wound of Patient #2, RN 3 indicated measures depth from the skin level outward, and with Patient #2 the depth measured would be how far the wound protrudes from the skin. During an interview on 07/12/2024 at 3:01 PM, when asked how to measure the depth of the wound of Patient #2, LPN 1 indicated when the wound had a small open area would measure the depth. 410 IAC 17-14-1(a)(1)(B)

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide services as ordered by the physician and included in the plan of care (POC) for 1 of 5 active records reviewed (Patient #4). Findings include: 1. Review of an agency policy titled “Care Management and Plan of Care” indicated the agency provides the patient with the services according to the individualized POC that is developed. 2. Review of the registered nurse (RN) job description indicated the RN provides services as indicated in the POC. 3. Review of the medical record of Patient #4 included a POC for certification period 06/13/2024 – 08/11/2024 that included skilled nurse interventions at each visit for wound vac (removes the pressure over a wound, which helps to reduce swelling and helps clean the wound) dressing changes. Review of a physician order dated 06/17/2024 indicated the skilled nurse was to make five visits for one week to Patient #4 effective 06/16/2024. Review of the skilled nurse visits made the week of 06/16/2024 – 06/22/2024 indicated the RN made two visits that week, on 06/17/2024 and on 06/19/2024. Documentation failed to evidence the SN made five visits as ordered. During an interview on 07/12/2024 at 3:08 PM, when asked why 5 SN visits were not made the week of 06/16/2024 – 06/22/2024 as ordered, the administrator indicated the previous clinical manager must have approved the order before making the corrections.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the accuracy of the medication profile for 1 of 2 home visit observations (Patient #3). Findings include: During a home observation on 7/12/2024 with Patient #3, licensed practical nurse (LPN) 2 compared Patient #3’s pill bottles with the medication list on their computer tablet. LPN 2 indicated the medication list had the same medications listed twice. The Clinical Manager, also at the visit, looked at the tablet and indicated they would need to discontinue one of the duplicate entries. The duplicate entries included amlodipine – benazepril (for high blood pressure), atorvastatin (for high cholesterol), metformin (for diabetes), low – dose aspirin (may reduce risk of heart attack and stroke), and metoprolol tartrate (for hypertension). The agency failed to ensure the accuracy of the medical record. During an interview on 7/12/2024 at 3:10 PM, LPN 2 indicated they did not know why the medications were listed twice or were not fixed at previous visits. LPN 2 indicated this was the first time they had seen the medications listed twice. During an interview on 7/12/2024 at 3:15 PM, the Administrator indicated the EMR duplicated the medications. When asked, the Alternate Clinical Manager indicated the nurse would see the medication already listed in the system and should have discontinued the duplicate. 410 IAC 17-15-1(a)(7)

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure patient’s clinical records would be made available to the patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first) for 1 of 1 agency. Findings include: During an interview on 9/11/2023 at 10:57 AM, the Administrator indicated he talked to Person 9 (the Corporate Compliance Officer) to follow up on if they charged for copies of records, and indicated Person 9 told him the agency admission booklet was used for all entities under the corporation (multiple states). Review of the agency admission booklet with revised date of 06/2023, indicated the patient will be charged a reasonable copying fee for requests of medical records. Review of an agency policy dated 08/01/2021 and titled “Individual Rights Regarding Records Contained in a Designated Record Set (Including Fees)” indicated an individual will receive access to medical records within 30 days of request, and may be charged a fee for copying, postage, and preparation of the medical records. During an interview on 09/11/2023 at 10:58 AM, when asked why the agency policy indicates a fee will be charged for copying medical records and the timeframe is 30 days to receive requested medical records, the administrator did not respond.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR §484.102. Survey Dates: 6/08, 6/09, 6/19 - 6/23, 6/26 - 6/29, and 7/11 (2023) Active Census: 190 At this Emergency Preparedness survey, Saint Joseph VNA Home Care was found not in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR §484.102.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the agency's Emergency Plan was also based on, and included a documented, community-based Hazard Vulnerability Assessment (HVA), utilizing an all-hazards approach. The findings include: Review of an agency policy dated 10/31/2022, titled "Emergency Management Plan", evidenced the current HVA was based on the agency's 2022 HVA, and review of actual events; and failed to evidence the plan was also based on a community-based HVA, or an all-hazards approach was used. Review of a binder with last review date 7/22/2022, titled “Emergency Plan”, failed to evidence a documented community-based HVA for the geographic area the agency served. During an interview on 7/11/2023 at 12:25 PM, the Administrator indicated the hazard vulnerability analysis was where they rated themselves, how often events occurred, and the probability; and the analysis was reviewed yearly. The Office Manager indicated the "Emergency Plan" binder was the only book for Emergency Preparedness. The Registered Nurse (RN) Educator indicated the HVA was based on "here", and how often it happened, and the Administrator indicated they looked at the news and weather websites.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure its communication plan include the names and contact information for volunteers. The findings include: Review of an agency policy dated 10/31/2022, titled "Emergency Management Plan", evidenced the agency would maintain a list of names and contact information for volunteers. Review of a binder with last review date 7/22/2022, titled “Emergency Plan”, failed to evidence a list of names and contact information for volunteers. During an interview on 7/11/2023 at 12:25 PM, the Administrator indicated he wasn't aware of volunteers. The Registered Nurse (RN) Educator indicated she needed to look into the agency's use of volunteers, and they (agency) partnered with Entity 5 (a hospital). The Administrator indicated there wasn't a written agreement with Entity 5. During an interview on 7/11/2023 at 3:04 PM, the Human Resource (HR) Manager indicated they used non-clinical support from Entity 5, they would validate prior to using them, and they weren't addressed as volunteers.

This visit was for a Federal Complaint, and fully extended survey of a Deemed home health agency provider, and a State Re-Licensure survey of a Home Health Provider. This survey was fully extended on 7/11/2023. Survey Dates: 6/08, 6/09, 6/19 - 6/23, 6/26 - 6/29, and 7/11 (2023) Complaint #: 99246 related and unrelated deficiencies were cited 12-Month Unduplicated Skilled Admissions: 1728 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. During this Federal Complaint Survey, Saint Joseph VNA Home Care was found to be out of compliance with the Conditions of Participation §484.55: Comprehensive Assessment of Patients; §484.60: Care Planning, Coordination of Services, and Quality of Care; §484.65 Quality Assessment and Performance Improvement and §484.105: Organization and Administration of Services, as related to this complaint. Based on the Condition-level deficiencies during the 7/11/2023 survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 7/11/2023. 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 7/11/2023 and continuing through 7/10/2025. Quality Review Completed on 7/22/23

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all agency patients received contact information for the agency's Administrator, for 4 of 4 home visits observed with patients who had a Patient Information Handbook (Patient #3, 6, 17, 19). The findings include: Review of an agency policy, dated 3/29/2023, titled "PATIENT RIGHTS AND RESPONSIBILITIES", stated, "... In advance of furnishing care to the patient or during the initial evaluation visit before the initiation of treatment, the patient is informed both verbally and in writing of all rights including ... The patient / Legal representative will be provided with the contact information for the administrator in order to make a complaint if needed ...." Review of the agency's "Patient Information Handbook" dated 2016, evidenced a section titled "Your Rights and Responsibilities", evidenced the patient could submit a complaint in person, by mail, by fax, or by email. The document evidenced a sticker on the first page of the booklet, which indicated the name of the Regional Director of Operations, but failed to indicate/clarify the name of the agency's Administrator, the business address of the Administrator, the agency's fax number, or the Administrator/agency email; indicated complaints related to violation of privacy rights should be directed to the corporate level (not an agency employee) Compliance Officer (Person 9); and contact information for Person 9 was provided in order to file an appeal (of investigation findings). Home visits observed with Patients #3, 6, 17, and 19, all revealed they received the agency's "Patient Information Handbook", dated 2016, but failed to evidence the Administrator's contact information. During an interview on 6/08/2023 at 2:25 PM, the Human Resources (HR) Manager indicated the agency's "Patient Information Handbook" (dated 2016) was the current information they gave their patients upon admission. During an interview on 6/26/2023 at 11:26 AM, (with regard to the Patient Information Handbook), the Administrator indicated the patients wouldn’t know who the administrator was in the handbook, they would have to call the office and someone would tell them.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all agency patients received written notice of the patient's rights and responsibilities, and the agency's transfer and discharge policies, for 4 of 4 home visits observed with patients who had an agency Patient Information Handbook (Patient # 3, 6, 17, 19). The findings include: A review of the agency's "Patient Information Handbook" dated 2016, evidenced a section titled "Your Rights and Responsibilities", which failed to evidence all of the patient's rights based on current federal regulations that took effect on January 13, 2018, and failed to evidence the section for the agency's transfer and discharge policies was based on current federal regulations. A review of an agency policy dated 6/29/1992, titled "PATIENT RIGHTS AND RESPONSIBILITIES", also failed to include all of the patient's rights based on current federal regulations that took effect on January 13, 2018. During home visits with Patients #3, 6, 17, and 19, all revealed they received the agency's "Patient Information Handbook", dated 2016. During an interview on 6/08/2023 at 2:25 PM, the Human Resources (HR) Manager indicated the agency's "Patient Information Handbook" (dated 2016) was given to their patients upon admission.

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to investigate complaints made by the patient and/or caregiver(s), for 1 of 1 clinical record reviewed with a complaint made to a clinician during a home visit (Patient #9). The findings include: Review of the agency's complaint log on 6/09/2023 at 9:31 AM failed to evidence any complaints on behalf of Patient # 9 were documented, investigated, or resolved. A review of the agency's "Patient Information Handbook" dated 2016, evidenced a section titled "Your Rights and Responsibilities", failed to evidence the patient had the right to have the home health agency investigate complaints. A review of an agency policy dated 3/29/2023, titled "PATIENT RIGHTS AND RESPONSIBILITIES", stated, "... In advance of furnishing care to the patient or during the initial evaluation visit before the initiation of treatment, the patient is informed both verbally and in writing of all rights including ... To have complaints investigated ...." Clinical record review for Patient #9 (start of care 3/30/2023), evidenced a nursing evaluation visit dated 5/31/2023, which indicated the patient received assistance from friends or neighbors living outside the home, and a person who resided in the home. A review of a nursing visit note dated 6/02/2023 revealed a neighbor (Person 12) reported that the patient's Power of Attorney (not further specified) has been stealing from the patient, the patient's electricity was shut off on 5/31/2023, the patient gave the POA $600 to pay the bill but it was never paid. The LPN filed a report with Adult Protective Services (APS) and notified Clinical Manager 2. A review of a nursing visit note dated 6/05/2023 revealed that the RN spoke to staff at Person 10's (certifying physician) office, to report a homeless caregiver living with the patient, asking for money, and not tending to his needs. The document failed to evidence that the RN notified the Clinical Manager. During an interview on 6/20/2023 at 2:57 PM, Clinical Manager 2 indicated Medical Social Worker (MSW) 1 advised her that once an APS referral was made, it was up to their (APS) social workers to handle the situation. The Administrator indicated he didn't know a lot about this patient, and he didn't recall that the patient was referred to APS. Clinical Manager 1 indicated he wasn't aware that money was taken and utilities were shut off. During an interview on 6/21/2023 at 2:23 PM, Clinical Manager 2 indicated since the clinicians had already contacted APS, there really wasn’t much more the agency could do. During an interview on 6/27/2023 at 11:46 AM, MSW 1 indicated she felt like this patient did slip through the cracks, and she felt bad about that.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to document the existence and resolution of a complaint for 1 of 1 clinical record reviewed with a complaint made to a clinician during a home visit (Patient #9). The findings include: 1. Review of the agency's "Patient Information Handbook" dated 2016, evidenced a section titled "Your Rights and Responsibilities", failed to evidence the patient had the right to have the home health agency document both the existence of the complaint. 2. Review of an agency policy dated 3/29/2023, titled "PATIENT RIGHTS AND RESPONSIBILITIES", indicated The agency must document the existence and resolution of complaints. 3. Clinical record review for Patient #9 (start of care 3/30/2023), contained a nursing visit note dated 6/02/2023, which revealed a neighbor (Person 12) complained that the patient's Power of Attorney (not further specified) has been stealing from the patient, the patient's electricity was shut off 5/31/2023, the patient gave the POA $600 to pay the bill but it was never paid. The document indicated the LPN notified Clinical Manager 2. The complaint log failed to evidence the existence and resolution of this complaint made by Person 12. During an interview on 6/21/2023 at 2:23 PM, Clinical Manager 2 indicated since the clinicians had already contacted APS, there really wasn’t much more the agency could do. 410 IAC 17-12-3(c)(2)

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to report the allegations of misappropriation of money to local authorities, for 1 of 1 clinical record reviewed with reported misappropriation of patient property (Patient #9). The findings include: Clinical record review for Patient #9 (start of care 3/30/2023), contained a nursing visit note dated 6/02/2023 revealing a neighbor (Person 12) complained to her that the patient's Power of Attorney (not further specified) has been stealing from the patient, the patient's electricity was shut off on 5/31/2023, and the patient gave the POA $600 to pay the bill but it was never paid. The agency failed to evidence that the local police were contacted, or that the patient declined to contact the local police, for alleged theft. During an interview on 6/21/2023 at 2:23 PM, Clinical Manager 2 indicated since the clinicians had already contacted APS, there really wasn’t much more the agency could do.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: the Physical Therapist (PT) completed a full head to toe comprehensive assessment/reassessment (Please see tag G0528); the patient's clinical record contained a complete list of the patient's current medications, and/or the physician was promptly notified of any significant potential drug interactions identified (Please see tag G0536); and failed to ensure a comprehensive reassessment was conducted when the patient experienced a significant change in condition (Please see tag G0544). 1.Clinical record review for patient #12 was completed on 6/28/2023 (start of care 6/03/2023) for certification period 6/03/2023- 8/01/2023. Record review for initial plan of care evidenced the patient’s primary diagnosis was type 2 diabetes with hyperglycemia (abnormally high blood sugar levels); and other pertinent diagnoses included paroxysmal atrial fibrillation (irregular heartbeat), hypertension (high blood pressure), Polymyalgia Rheumatica (joint pain and stiffness), UTI, and hyperlipidemia (high blood cholesterol). Record review indicated the patient was to check blood sugars three times a day and blood sugar parameter between 100-200 milligrams per decaliter (mg/dL). Record review of the initial comprehensive assessment completed on 6/03/2023, evidenced PT performed the assessment. The document evidenced the patient had multiple risk for hospitalization, was referred for home health care. The document failed to evidence the PT assessed heart, lung, or bowel sounds, skin for diabetic ulcer or skin breakdown, or blood sugars within acceptable range. During an interview on 6/26/2023 at 11:34 AM, the Administrator indicated “therapy only” services can address diabetic foot care and interventions. 2. Clinical record review for patient #15 was completed on 6/26/2023 (start of care 6/04/2023) for certification period 6/04/2023-8/02/2023. Record review for initial plan of care evidenced the patient’s primary diagnosis was UTI; other pertinent diagnoses included rectal cancer, hypertension, dysphasia (difficulty swallowing), weakness and hypothyroidism. Record review of the initial comprehensive assessment completed on 6/04/2023, evidenced PT performed the assessment. The document evidenced the patient had multiple risk factors for hospitalization, was referred to home health care. The document failed to evidence the PT assessed heart, lung, or bowel sounds. During an interview on 6/26/2023 at 2:37 PM, the Administrator indicated no interventions were listed for patient goals related to UTI. This is something the PT should be doing and add pathway for diagnosis. At 2:38 PM, The PT can place pathways and indicate patient symptoms without any other assessment. 3. Clinical record review for patient #16 was completed on 6/28/2023 (start of care 5/05/2023) for certification period 5//05/2023-7/03/2023. Record review for initial plan of care evidenced the patient’s primary diagnosis was Lennox-Gastaut Syndrome (seizure disorder that begins in childhood); other pertinent diagnoses intellectual disabilities, and falls. Record review of the initial comprehensive assessment completed on 5/05/2023, evidenced PT performed the assessment. The document evidenced the patient was referred for home health after hospitalization with discharge on 5/03/2023 for rectal bleeding and buttock laceration. Record review failed to evidence the PT assessed the patient’s heart, lungs, and bowel sounds or wound assessment. During an interview on 6/29/2023 at 12:41, the Administrator indicated the patient’s are being discharged home with higher acuity. During an interview on 6/26/2023 at 11:14 AM, the RN Educator indicated the PT information on patient baseline would come from interview with patient’s family. 4. Clinical record review for patient #19 was completed on 6/26/2023 (start of care 6/07/2023) for certification period 6/07/2023-8/05/2023. Record review of the initial plan of care evidenced the patient’s primary diagnosis was right humerus fracture; and other pertinent diagnoses included Congestive heart failure (weakened heart condition), Chronic obstructive pulmonary disease (airflow blockage and breathing problems), and hemodialysis (removal of waste and fluid from blood). Record review of the initial comprehensive assessment completed on 6/07/2023 evidenced PT performed the assessment. The document evidenced the patient was referred for home health. Record review failed to evidence the PT assessed the patient’s heart, lungs, bowel sounds, and dialysis access. During an interview on 6/26/2023 at 11:13 AM, the Administrator indicated the PT should still be doing a full assessment, but the PT will not check for bruit and thrill (sound and vibration) of the dialysis access. 5. Clinical record review for patient #20 was completed on 6/26/2023 (start of care 5/25/2023) for certification period 5/25/2023-7/23/2023. Record review of the initial plan of care evidenced the patient's primary diagnosis of Parkinson (uncontrolled and unintended movements); and other pertinent diagnoses included diabetes, hypertension, hemodialysis. Record review of the initial comprehensive assessment completed on 5/25/2023 evidenced PT performed the assessment. The document evidenced the patient was referred to home health care after a fall with injury and a left Arm fracture with cast placement. Record review failed to evidence the PT assessed the patient’s heart, lungs, bowels, skin, and dialysis access site. During an interview on 6/26/2023 at 11:10 AM, RN Educator indicated the “therapy only” cases look at the patient for changes on tolerating therapy and shortness of breath with rest. 1. Review of an agency job description with revised date March 2009, titled "Performance Evaluation and Job Description ... Physical Therapist (PT)" stated, "... Quality of Care - Criteria ... Accurately assesses clients at admission and other required timepoints ... Assesses the client's condition ... Develops appropriate assessment-based plan of treatment ...." 2. Review of an agency policy with review date 9/01/2022, titled, "ASSESSMENT/REASSESSMENT", stated, "... Assessments and reassessments are done ... to determine the care and services needed by the patient ... The initial assessment determines the need for care/services ...Patients receive a comprehensive assessment initially and on an ongoing basis ... assessment process involves ... Gathering of data about the patient's physical and psychosocial status, home environment, family and support system, educational and discharge needs. This data is both subjective and objective ... The initial assessment determines the need ... for further assessment ... reassessment is determined by ... Diagnosis changes ... Significant condition change ... Care environment or support system changes ... Depending on the patient's diagnosis, symptoms, or deficits, the patient may require intervention by another discipline ...." 3. Clinical record review for Patient #3 was completed on 6/27/2023 (start of care date 5/27/2023, certification period 5/27/2023 - 7/25/2023). Record review of the initial plan of care evidenced the patient's primary diagnosis was gastrointestinal (GI) (any part of the digestive tract) hemorrhage (profuse bleeding); and other pertinent diagnoses included atrial fibrillation (irregular heart beat), urinary tract infection (UTI), chronic heart failure, diabetes, hypothyroidism, and history of lung and other blood clots. Record review of the initial comprehensive assessment completed on 5/27/2023, evidenced PT performed the assessment. The document evidenced the patient had multiple risks for hospitalization, the patient was experiencing high health risks, was referred for home health after hospitalization with discharge on 5/25/2023, for GI bleeding, anemia, and UTI; but failed to evidence a patient-specific assessment was completed to include assessment of the patient's heart, lung, or bowel sounds; assessed for signs/symptoms of UTI, assessed for presence of blood clots, or assessed when/if the patient checked her blood sugar levels. During an interview on 6/20/2023 at 2:57 PM, the RN Educator indicated there would be a checked box in the electronic medical record (EMR) if they checked lung sounds. 4. Clinical record review for Patient #4 was completed on 6/27/2023 (start of care date 3/27/2023, certification period 3/27/2023 - 5/25/2023). Record review evidenced a coordination note dated 5/02/2023, which indicated the patient was hospitalized on 5/02/2023 for a scheduled hip revision surgery on 5/03/2023, and the anticipated discharge date was 5/04/2023. Record review evidenced a resumption of care (comprehensive reassessment) visit was completed by a PT on 5/08/2023, which evidenced the patient had a dressing over the post-surgical left hip incision, the patient's family member managed the incision care/dressing changes; but failed to evidence a patient-specific assessment was completed to include assessment of the incision. Record review evidenced a communication note dated 5/11/2023, which evidenced the patient was re-hospitalized on 5/11/2023 for drainage to the surgical site (left hip). Record review evidenced a resumption of care visit was completed by a PT on 5/15/2023, after the patient's hospitalization for seroma (a mass or lump caused by a buildup of clear fluid in a tissue, organ, or body cavity) and excessive drainage to the left surgical hip. The document evidenced the patient had a Prevena (brand name) negative pressure wound treatment (NPWT) device (a portable, disposable system, which uses negative pressure [like a vacuum] to help heal and protect the incision, to be managed only by qualified clinical professionals) in place to the left hip incision, and family was independent with emptying the cannister when full; but failed to evidence a patient-specific assessment was completed to include assessment of the family's ability to correctly empty the cannister, assessed a description of the fluid collected in the cannister, the amount, or how often it was being changed. During an interview on 6/27/2023 at 3:47 PM, the Registered Nurse (RN) Educator indicated the patient's 2nd hospitalization (5/11/2023, unplanned), was due to drainage from the surgical site. Regarding the resumption of care on 5/15/2023, the RN Educator indicated she assumed the hospital would have trained the patient/family about the management/treatment of the Prevena NPWT device, and they (agency) didn't typically manage those devices. During an interview on 6/27/2023 at 3:54 PM, the Administrator indicated the patient was transferred into the hospital again on 5/25/2023 for ongoing surgical incision drainage issues. 5. Clinical record review for Patient #5 was completed on 6/29/2023 (start of care date 4/06/2023). Record review evidenced an initial comprehensive assessment was completed by a PT on 4/06/2023. The document evidenced the patient's primary diagnosis was sepsis (occurs when chemicals are released in the bloodstream to fight an infection, which triggers inflammation throughout the body, and could cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even resulting in death); and other diagnoses included hydronephrosis (condition characterized by excess fluid in a kidney due to a backup of urine, caused by a blockage in the tube that connects the kidney to the bladder; possible causes include infection; and symptoms include difficulty urinating and pain in the side, abdomen, or groin); the patient had shortness of breath, poor hydration and appetite, had an ileostomy (an artificial opening in the abdomen to drain feces); prior to hospitalization/home care services, the patient received intravenous (IV) saline (sterile salt water) infusions twice weekly for the past 2 years, after the ileostomy was created; and family reported the patient sustained an injury to the left elbow (not further detailed) while hospitalized, and was keeping it covered with a bandage. Record review failed to evidence a patient-specific assessment was completed to include assessment of lung sounds, the amount, type, or frequency of nutritional/fluid intake, assessment of the ileostomy, amount or description of output from the ileostomy, or description of the elbow wound. Record review evidenced an order dated 4/17/2023, which indicated the patient's hospitalization was for dehydration and acute (sudden) kidney failure. Record review evidenced PT performed a resumption of care on 4/17/2023. The document evidenced the patient had slight breathlessness, poor hydration, and an ileostomy "on the right side"; but failed to evidence a patient-specific assessment was completed to include assessment of lung sounds, the amount, type, or frequency of fluid intake, assessment of the ileostomy, or amount or description of output from the ileostomy. During an interview on 6/29/2023 at 12:15 PM, the Administrator indicated they would expect the PT to assess wounds. 6. Clinical record review for Patient #10 was completed on 6/27/2023 (start of care 4/22/2023). Record review evidenced an initial plan of care (certification period 4/22/2023 - 6/20/2023), which evidenced the patient's primary diagnosis was chronic obstructive pulmonary disease (COPD) with acute (severe and sudden onset) exacerbation (increase in symptom intensity), and additional diagnoses included asthma, acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions), and hyperglycemia (high blood sugar levels); and the patient required continuous supplemental oxygen (O2). Record review evidenced the initial comprehensive assessment was completed by a PT on 4/22/2023. The document evidenced the patient's COPD was poorly controlled, and the patient needed frequent adjustments in treatments and dose monitoring; the primary home care focus was shortness of breath, and the PT observed the patient not wearing O2 upon arrival because she couldn't switch the O2 cylinders, assessed the patient's oxygen (O2) saturation was 80% (88% - 92% O2 level is considered safe for someone with moderate to severe COPD, levels below 88% become dangerous, and any level 80% or lower is dangerous for the vital organs and needs urgent treatment), and after the PT switched the cylinders and administered O2, the patient's O2 level increased to 96%; but failed to evidence a patient-specific assessment was completed to include assessment of lung sounds, or the patient's competency to change the O2 cylinders and maintain continuous O2 administration. During an interview on 6/27/2023 at 4:12 PM, the RN Educator indicated PTs don't assess lung sounds. 7. During an interview on 6/26/2023 at 11:12 AM, the RN Educator indicated a comprehensive assessment for Nursing consisted of a full body assessment, assessing heart, lungs, pedal pulses, and skin; and for therapies, it’s vitals, looking at the patient for any changes, and how they’re tolerating therapy. The Administrator indicated the Therapists should also still assess all systems for the comprehensive assessments, and they should still be assessing psychosocial status and integumentary system (skin). 8. During an interview on 6/26/2023 at 11:13 AM, the RN Educator indicated the Therapist assesses any changes from baseline, and if they feel it’s appropriate, they would get a referral for nursing; and they obtained baseline data from patient/family word of mouth. The Administrator indicated baseline data was also obtained from hospital notes. 9. During an interview on 6/27/2023 at 5:04 PM, the Administrator indicated there’s no separate PT/OT policy for comprehensive assessment, and it’s the same expectations for RN and therapists.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the Physical Therapist (PT) performed a full head to toe comprehensive assessment/reassessment for 8 of 9 clinical records reviewed (Patient #3, 4, 5, 10, 12, 13, 16, 19, 20). The findings include: 1. Review of an agency job description with revised date March 2009, titled "Performance Evaluation and Job Description ... Physical Therapist (PT)" stated, "... Quality of Care - Criteria ... Accurately assesses clients at admission and other required time points... Assesses the client's condition ... Develops appropriate assessment-based plan of treatment ...." 2. Review of an agency policy with review date 9/01/2022, titled, "ASSESSMENT/REASSESSMENT", stated, "... Assessments and reassessments are done ... to determine the care and services needed by the patient ... Patients receive a comprehensive assessment initially and on an ongoing basis ... assessment process involves ... Gathering of data about the patient's physical and psychosocial status ... educational and discharge needs. This data is both subjective and objective ...." 3. Clinical record review for Patient #3 (start of care date 5/27/2023) contained a plan of care for the certification period 5/27/2023 - 7/25/2023. The patient's diagnoses included but were not limited to gastrointestinal (GI) (any part of the digestive tract) hemorrhage (profuse bleeding), atrial fibrillation (irregular heartbeat), urinary tract infection (UTI), chronic heart failure, diabetes, history of lung and other blood clots. Review of the initial comprehensive assessment (dated 5/27/2023), revealed it was performed by a PT. The document was referred for home health after hospitalization for GI bleeding, anemia, and UTI. The assessment failed to evidence that the patient's heart, lung, and bowel sounds were assessed as well as signs/symptoms for UTI, the presence of blood clots, if/when the patient checked her blood sugar levels. During an interview on 6/20/2023 at 2:57 PM, the Registered Nurse (RN) Educator indicated there would be a checked box in the electronic medical record (EMR) if they checked lung sounds. 4. Clinical record review for Patient #4 (start of care date 3/27/2023), contained a resumption of care order dated 5/08/2023, which indicated PT was to perform/teach wound care to the left hip incision/suture site. Review of the resumption of care (comprehensive reassessment) visit that was completed by a PT on 5/08/2023, revealed the patient had a dressing over the post-surgical left hip incision, the patient's family member managed the incision care/dressing changes. The document failed to evidence that the PT assessed the patient's incision, or assessed the family member's competency to provide correct wound care. Review of a communication note dated 5/11/2023 evidenced the patient was re-hospitalized on 5/11/2023 for drainage to the surgical site (left hip). Review of a resumption of care order dated 5/15/2023 revealed the patient had a Prevena (brand name) negative pressure wound treatment (NPWT) device (a portable, disposable system, which uses negative pressure [like a vacuum] to help heal and protect the incision, to be managed only by qualified clinical professionals), but failed to evidence who managed the device, or how often/the next time the dressing was due to be changed. Review of a resumption of care visit dated 5/15/2023 revealed it was completed by a PT. T document indicated the patient was hospitalized for seroma (a mass or lump caused by a buildup of clear fluid in a tissue, organ, or body cavity) and excessive drainage to the left surgical hip. The document evidenced the patient had a Prevena NPWT device in place to the left hip incision but failed to document a description of the fluid collected in the canister, the amount, or how often it was being changed. During an interview on 6/27/2023 at 3:47 PM, the RN Educator indicated she assumed the hospital would have trained the patient/family about the management/treatment of the Prevena NPWT device, and they (the agency) didn't typically manage those devices. During an interview on 6/27/2023 at 3:54 PM, the Administrator indicated the patient was transferred to the hospital again on 5/25/2023 for additional surgical incision drainage issues. 5. Clinical record review for Patient #5 (start of care 4/06/2023) contained an initial comprehensive assessment that was completed by a PT on 4/06/2023. The document evidenced the following: the patient's primary diagnosis was sepsis (inflammation throughout the body caused by infection, which could cause organ failure, shock, or death); and other diagnoses included, but were not limited to hydronephrosis (excess fluid in a kidney due to a backup of urine, and possible causes include infection). The assessment indicated the patient had shortness of breath, poor hydration, and appetite, and had an ileostomy (an artificial opening in the abdomen to drain feces). The assessment also indicated prior to hospitalization/home care services, the patient received intravenous (IV) saline (sterile salt water) infusions twice weekly for the past 2 years after the ileostomy was created, the family reported the patient sustained an injury to the left elbow (not further detailed) while hospitalized, and was keeping it covered with a bandage. The assessment failed to evidence PT assessed lung sounds; the amount, type, or frequency of nutritional/fluid intake, the ileostomy, the amount/description of output from the ileostomy, or assessed the elbow wound. A review of an order dated 4/13/2023 indicated the patient was hospitalized from 4/07/2023 - 4/13/2023 for dehydration and acute (sudden) kidney failure. On 4/17/23, PT performed the resumption of care comprehensive assessment. The document indicated the patient had slight breathlessness, poor hydration, and an ileostomy "on the right side" but failed to evidence the PT assessed lung sounds, the amount, type, or frequency of fluid intake, assessment of the ileostomy, or amount or description of output from the ileostomy. During an interview on 6/29/2023 at 12:15 PM, the Administrator indicated they would expect the PT to assess wounds. Clinical Manager 1 indicated family told the PT about the IV infusions but he didn't think there was anything in the orders to address the patient's need for IV saline infusions. 6. Clinical record review for Patient #10 (start of care 4/22/2023) contained an initial plan of care (certification period 4/22/2023 - 6/20/2023). The patient's primary diagnoses included but were not limited to chronic obstructive pulmonary disease (COPD) with acute (severe and sudden onset) exacerbation (increase in symptom intensity), and additional diagnoses included, but were not limited to asthma, acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions), and hyperglycemia (high blood sugar levels). The document indicated the patient required continuous supplemental oxygen (O2). Review of the initial comprehensive assessment that was completed by a PT on 4/22/2023 revealed the patient's COPD was poorly controlled, the patient needed frequent adjustments in treatments and dose monitoring, the primary home care focus was shortness of breath, and the PT observed the patient not wearing O2 upon arrival because she couldn't switch the O2 cylinders, assessed the patient's oxygen (O2) saturation was 80% (any level 80% or lower is dangerous), and after the PT switched the cylinders and administered O2, the patient's O2 level increased. The document failed to evidence the PT assessed lung sounds, the patient's competency to change the O2 cylinders and maintain continuous O2 administration, how often or if the patient checked her blood sugar levels, or what the blood sugar was on the day of assessment. During an interview on 6/26/2023 at 11:31 AM, the Administrator indicated blood sugar levels would be documented in the vital sign section of the comprehensive assessment, and the RN Educator indicated blood sugar assessment/monitoring wasn't on the "pathway" for therapy, and Nursing did that. During an interview on 6/27/2023 at 4:12 PM, the RN Educator indicated PTs don't assess lung sounds. 7. Clinical record review for patient #12 (start of care 6/03/2023) contained an initial plan of care for the certification period 6/03/2023- 8/01/2023. The patient’s diagnoses included but were not limited to primary type 2 diabetes with hyperglycemia (abnormally high blood sugar levels), paroxysmal atrial fibrillation (irregular heartbeat), and hypertension (high blood pressure). This document indicated the patient was to check blood sugars three times a day and blood sugar parameters between 100-200 milligrams per deciliter (mg/dL). Review of the initial comprehensive assessment dated 6/03/2023 revealed PT performed the assessment. The document failed to evidence the PT assessed heart, lung, or bowel sounds, skin for diabetic ulcer or skin breakdown, or blood sugars within an acceptable range. During an interview on 6/26/2023 at 11:34 AM, the Administrator indicated “therapy only” services can address diabetic foot care and interventions. 8. Clinical record review for patient #15 (start of care 6/04/2023) contained a plan of care for the certification period 6/04/2023-8/02/2023. The patient’s diagnoses included but were not limited to UTI, rectal cancer, and hypertension. Review of the initial comprehensive assessment dated 6/04/2023 revealed PT performed the assessment. The document failed to evidence the PT assessed heart, lung, or bowel sounds. During an interview on 6/26/2023 at 2:37 PM, the Administrator indicated no interventions were listed for patient goals related to UTI. This is something the PT should be doing and adding a pathway for diagnosis. At 2:38 PM, The PT can place pathways and indicate patient symptoms without any other assessment. 9. Clinical record review for patient #16 (start of care 5/05/2023) contained a plan of care for the certification period 5//05/2023-7/03/2023. The patient's diagnoses included but were not limited to Lennox-Gastaut Syndrome (a seizure disorder that begins in childhood) and falls. Review of the initial comprehensive assessment dated 5/05/2023 revealed PT performed the assessment. The document evidenced the patient was referred for home health after hospitalization for rectal bleeding and buttock laceration. Record review failed to evidence the PT assessed the patient’s heart, lungs, and bowel sounds or wound assessment. During an interview on 6/26/2023 at 11:14 AM, the RN Educator indicated the PT information on the patient baseline would come from an interview with the patient’s family versus an actual PT assessment. 10. Clinical record review for patient #19 (start of care 6/07/2023) contained a plan of care for the certification period 6/07/2023-8/05/2023. The patient’s diagnoses included but were not limited to right humerus fracture, congestive heart failure (weakened heart condition), chronic obstructive pulmonary disease (airflow blockage and breathing problems), and hemodialysis (removal of waste and fluid from blood). Review of the initial comprehensive assessment dated 6/07/2023 revealed PT performed the assessment. The document failed to evidence the PT assessed the patient’s heart, lungs, bowel sounds, and dialysis access. During an interview on 6/26/2023 at 11:13 AM, the Administrator indicated the PT should still be doing a full assessment, but the PT will not check for bruit and thrill (sound and vibration) of the dialysis access. 11. Clinical record review for patient #20 was completed on (start of care 5/25/2023) contained a plan of care for the certification period 5/25/2023-7/23/2023. The patient's diagnoses included but were not limited to Parkinson's (uncontrolled and unintended movements), diabetes, hypertension, and hemodialysis. Review of the initial comprehensive assessment completed on 5/25/2023 revealed PT performed the assessment. The document evidenced the patient was referred to home health care after a fall with injury and a left arm fracture with cast placement. The document failed to evidence the PT assessed the patient’s heart, lungs, bowels, skin, and dialysis access site. During an interview on 6/26/2023 at 11:10 AM, RN Educator indicated the “therapy only” cases look at the patient for changes on tolerating therapy and shortness of breath with rest. 12. During an interview on 6/26/2023 at 11:12 AM, the RN Educator indicated a comprehensive assessment for Nursing consisted of a full body assessment, including heart, lungs, pedal pulses, and skin. For therapist, they do vital signs, look for any changes, and how patient's are tolerating therapy. The Administrator indicated the Therapists should still assess all systems for the comprehensive assessments, and they should still be assessing the psychosocial status and integumentary system (skin). 13. During an interview on 6/26/2023 at 11:13 AM, the RN Educator indicated the Therapists obtained baseline data from patient/family word of mouth. The Administrator indicated baseline data was also obtained from hospital notes. 14. During an interview on 6/27/2023 at 5:04 PM, the Administrator indicated there’s no separate PT/OT policy for comprehensive assessment, and it’s the same expectations for RN and therapists. 410 IAC 17-14-1(a)(1)(A) & (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 ensure the patient's clinical record contained a complete list of the patient's current medications, and/or the physician was promptly notified of any significant potential drug interactions identified, for 8 of 20 clinical records reviewed (Patient #3, 6, 8, 12, 15, 16, 17, 19, 20). The findings include: 1. Clinical record review for patient #12 was completed on 6/28/2023 (start of care 6/03/2023) for certification period 6/03/2023- 8/01/2023. Record review evidenced a plan of care, which indicated patient’s medication included, but were not limited to fluconazole (treat and prevent fungal infections), Hydrocodone with acetaminophen (pain medication) and hydralazine (for treatment of high blood pressure). Record review indicated level 2 severe interaction between, fluconazole, hydrocodone with acetaminophen and hydralazine. Record review failed to evidence the agency notified the physician of the severe drug interactions. During an interview on 6/26/2023 at 12:01 PM, the RN Educator indicated agency policy indicated that the level two interaction is to notify physician within an hour and no documentation found of md notification for drug interaction. 2. Clinical record review for patient #15 was completed on 6/26/2023 (start of care 6/04/2023) for certification period 6/04/2023-8/02/2023. Record review evidenced a plan of care, which indicated patient’s medication included, but were not limited to oxybutynin chloride (bladder emptying) and potassium chloride (potassium supplement). Record review indicated a severe drug interaction between potassium chloride and oxybutynin. Record review failed to evidence the agency notified the physician of the severe drug interaction. During an interview on 6/26/2023 at 2:34 PM, the RN Educator indicated the agency should have discussed the medication interactions with the physician. 3. Clinical record review for patient #16 was completed on 6/28/2023 (start of care 5/05/2023) for certification period 5//05/2023-7/03/2023. Record review evidenced a plan of care, which indicated patient’s medication included, but were not limited to Clobazam (anti-seizure medication) and Omeprazole (stomach acid). Record review indicated a major drug interaction between Clobazam and Omeprazole. Record review failed to evidence the agency notified the physician of the major drug interactions. During an interview on 6/28/2023 at 2:37 PM, the Clinical Manager 1 indicated the physician notification was not found regarding the medication interactions. 4. Clinical record review for patient #17 was completed on 6/28/2023 (start of care 5/16/2023) for certification period 5/16/2023-7/14/2023. Review of the nurse note, which indicated patient’s medications included, but were not limited to Kaopectate (antidiarrhea) and Eliquis (blood thinner). Record review indicated a major drug interaction between Kaopectate and Eliquis. Record review failed to evidence the agency notified the physician of major drug interactions. During an interview on 6/28/2023 at 2:31 PM, Clinical Manager 1 indicated the agency process is to call physician with the interaction for further orders and inform the patient of the outcome of the call. 5. Clinical record review for patient #19 was completed on 6/26/2023 (start of care 6/07/2023) for certification period 6/07/2023-8/05/2023. Record review evidenced a plan of care, which indicated patient’s medications included but not limited to Diltiazem (a medication used to treat irregular heart rhythm) and Amiodarone (a medication used to treat irregular heart rhythm). Record review indicated a level 2 severe drug interaction between Diltiazem and Amiodarone. Record review failed to evidence the agency notified the physician of the severe drug interaction. During an interview on 6/26/2023 at 12:01 PM, the RN Educator indicated the agency policy indicated that the level two interaction is to notify physician within an hour and no documentation found of md notification for drug interaction. 6. Clinical record review for patient #20 was completed on 6/26/2023 (start of care 5/25/2023) for certification period /25/2023-7/23/2023. Record review evidenced a Physical Therapy (PT) note, which indicated a triple antibiotic ointment was in use. Record view failed to indicate area and reason for medication application. During an interview on 6/26/2023 at 1:50 PM, the Administrator indicated the antibiotic order was incorrect and order should contain detailed information about the site and reason for the ointment. 1. Review of an agency policy with last review date 9/01/2022, titled "MEDICATION ADMINISTRATION AND MEDICATION MANAGEMENT", stated, "... If a potential contraindication is identified or has already occurred, staff involved in the patient care will discuss benefits and risks to the patient with the patient, the patient’s physician, caregiver and/or relevant staff involved with the patient’s care, and document treatment and services ... Documentation of diagnoses or conditions for which the medications are prescribed ... Assessment of the patient, family and/or caregiver competency with medication administration before being allowed to administer medications ... Establishing with the patient/caregiver a medication schedule according to the physician’s orders including the name of the drug, dose, frequency, route, and any specific instructions ... Update the medication profile as needed ...." 2. A home visit observation occurred on 6/20/2023 at 9:30 AM with Patient #3, Occupational Therapist (OT) 3, and Clinical Manager 2. OT 3 reconciled the patient's medication bottles against the agency's current list, and the following medications were not included on the agency's medication list: levothyroxine (fill date 4/02/2023), oxybutynin (fill date 4/02/2023), low dose aspirin (the patient indicated she's been taking it for years), over-the-counter fiber supplement (OT 3 indicated she needed to add that one to the medication list as well), and midodrine (fill date 1/24/2023) (the patient indicated she didn't know if she was still taking that medication). The patient also indicated her physician "took her off of" her inhalers. Clinical record review for Patient #3 was completed on 6/27/2023, start of care date 5/27/2023. Record review evidenced an OT visit note dated 6/20/2023, which indicated the physician was notified for the medication discrepancies, and the OT was waiting for a return call. 3. A home visit was observed with Patient #6 on 6/23/2023 at 9:30 AM. The Administrator and Licensed Practical Nurse (LPN) 2 were present. LPN 2 reconciled the patient's medications against the agency's current list, and the following medications discrepancies/concerns were identified: albuterol inhaler (to open airway), calcium with vitamin D, insulin, jardiance (antidiabetic), and ozempic (antidiabetic/antiobesity) were on the agency's medication list, but not found in the home, and the patient said she's been out of them for a while, she couldn't afford her insulin or jardiance, and she only had samples of the ozempic; ipratropium/albuterol (helps control the symptoms of lung disease) nebulizer solution was on the agency's medication list, and the prescription box in the home was expired in November 2020. 4. A home visit observation occurred on 6/19/2023 at 10:10 AM with Patient #8, Registered Nurse (RN) 1, and Clinical Manager 1. RN 1 reconciled the patient's medication bottles against the agency's current list, and the following medications discrepancies were identified: clonidine (a medication to lower blood pressure) was listed on the agency medication list on 6/12/2023, to be taken twice daily "as needed", but failed to indicate when the medication was needed; RN 1 asked the patient if she knew the blood pressure parameters to take clonidine, and the patient indicated she didn't know when to take it; prednisone was listed on the agency's current medication list (entered 5/27/2023), but the patient indicated she previously told Licensed Practical Nurse (LPN) 2 she finished taking it; amitriptyline (antidepressant) was observed (fill date 6/05/2023), but failed to be included on the medication list, and the patient indicated she's been taking it for a few months. During an interview on 6/19/2023 at 12:53 PM, Patient #8 indicated she only took clonidine 1 time because it really knocked her "on her butt", and made her really tired, she really didn't know when to take it, and the nurses didn't go over every prescription bottle every visit like they did today (during the home visit). 5. A home visit observation occurred on 6/22/2023 at 2:00 PM with Patient #17, Physical Therapist (PT)1, and Clinical Manager 2. PT 1 reconciled the patient's medications against the agency's current list, and the following medications discrepancies were identified: the agency's medication list indicated the norco (narcotic pain medication) dose was 5 milligrams (mg), but the patient's prescription bottle indicated it was 10mg; imodium (anti-diarrheal), Pepto-Bismol (anti-diarrheal, heartburn, indigestion), and colace (stool softener) failed to be included on the agency's medication list; and the agency's medication list indicated the dose of temazepam (insomnia) was 15 mg, to be taken every night at bedtime, but the prescription bottle indicated the dose was 30mg, to be taken every night at bedtime only as needed.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure a comprehensive reassessment was conducted for 1 of 1 home visit observed when the patient experienced a significant change in condition (Patient #9). The findings include: Review of an agency policy with review date 9/01/2022, titled, "ASSESSMENT/REASSESSMENT", stated, "... Assessments and reassessments are done ... to determine the care and services needed by the patient ... Patients receive a comprehensive assessment initially and on an ongoing basis ... assessment process involves ... Gathering of data about the patient's physical and psychosocial status, home environment, family and support system ... Care environment or support system changes ...." A home visit was observed with Patient #9 on 6/20/2023 at 11:30 AM. Clinical Manager 1 and Licensed Practical Nurse (LPN) 1 were present. Prior to entering the home, Clinical Manager 1 indicated there was a suspected bedbug infestation in the home, he was unaware until today, and this was a significant change from what he knew about the patient. Once in the home, the patient presented alert and oriented, lying on his bed in the living room, and the bed linens were visibly soiled; the bed and floor had innumerable live and dead bedbugs on it, the home had a very foul odor, and there were urinals with urine in them sitting on furniture; the patient's skin and hair was visibly dirty, was clothed only in a soiled t-shirt, a soiled brief, and soiled socks. LPN 1 indicated she was supposed to fill the medication pill planner every week, confirmed there were no current medications in the home to fill the medication planner, and this was not a new problem. LPN 1 assisted the patient to a sitting position, assessed the patient's lungs, and indicated he was congested. LPN 1 removed the patient's socks. The patient's feet were dirty, there was unidentifiable black/brown matter between the toes, and all toenails were long and jagged. During this time, the patient indicated he was losing weight, and he complained of severe pain in his lower flank/back with any movement. Clinical record review for Patient #9 (start of care 3/30/2023) contained a plan of care for the certification period 5/29/2023 - 7/27/2023. The patient's diagnoses were pneumonitis due to inhalation of food and vomit (an infection of the lungs), benign prostatic hyperplasia with lower urinary tract symptoms (enlarged prostate which causes blocked urine flow), and moderate protein-calorie malnutrition (inadequate intake of nutritional food). Review of visit notes dated 5/31/2023, 6/01/2023, and 6/02/2023, indicated the patient had no pain or respiratory issues. Review of a nursing visit note dated 6/05/2023 indicated the patient's breath sounds were abnormal with rhonchi (a sound heard due to an obstruction or an increased amount of secretions in the airways/lungs), had poor appetite and hydration, and the patient had no pain. Review of a PT visit note dated 6/08/2023 evidenced the patient had a cough that began 2-3 days ago and denied any pain. Review of a PT visit note dated 6/09/2023 evidenced the patient still had a cough, had "yellowish phlegm", and denied any pain. Review of an Occupational Therapy (OT) evaluation visit note dated 6/11/2023 evidenced the patient complained of pain in the back and knees, current pain was "4" (pain scale 0-10, with 0= no pain, and 10= worst pain ever), the worst pain was "7", and the patient had "very slight breathlessness", and experienced shortness of breath. Review of a nursing visit note dated 6/14/2023 evidenced the had sinus/nasal congestion. Record review evidence a RN nursing visit note (not a comprehensive assessment/reassessment) dated 6/28/2023, which evidenced the patient had back pain, and skin was mottled (impaired blood flow under the skin) with poor turgor (decrease in skin turgor is a late sign of dehydration). The clinical record failed to evidence that a clinician performed an updated comprehensive reassessment. During an interview on 6/21/2023 at 2:23 PM, Clinical Manager 1 confirmed the agency hasn't sent an RN to reassess the patient after the home visit. During an interview on 6/23/2023 at 11:46 AM, the RN Educator indicated an RN had to have seen the patient at some point, the Administrator indicated the last time an RN saw the patient was 6/05/2023, and the patient should be due for an RN to perform an LPN supervisory visit soon, like next week. During an interview on 6/26/2023 at 5:35 PM, Patient #9 indicated his lower back hurt, the pain level was 7-8 with movement, and his urine was really dark yellow and smelled bad. During an interview on 6/28/2023 at 2:33 PM, the patient indicated he still had pain with any movement, his urine had an odor, and it was dark colored. 410 IAC 17-14-1(a)(1)(B)

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 Administrator failed to ensure: the agency only accepted patients for services if the needs of the patient could be met and services were not provided absent of a physician's order (see tag G0570); all patients had individualized vital sign parameters specific to their needs (see tag G0572); failed to ensure all patients' plans of care including all required elements (see tag G0574); and failed to ensure the clinician promptly notified the physician/ practitioner for a change in the patient's condition or needs (see tag G0590); failed to assure communication with all physicians involved in the plan of care (see tag G602); coordinate with outside providers (see tag G606); ensure it prepared and/or provided all patients with an up-to-date written medication schedule (see tag G616); ensure it provided all patients with written information for all treatments administered by the agency (see tag G618). These deficient practices affected all 20 clinical records reviewed. (Patient #1 - 20) The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care. With regard to G0570, the findings include: 1. Clinical record review for patient #13 was completed on 6/28/2023 (start of care 5/17/2023), for certification period 5/17/2023-7/15/2023. Record review evidenced a plan of care, which indicated occupational therapy (OT) ordered for 1 time a week for 5 weeks to start on 5/21/2023. Patient was hospitalized from 5/30/2023 to 6/02/2023 and OT was not ordered post hospitalization. Record review failed to evidence patient’s therapy needs were met. During an interview on 6/28/2023 at 2:54 PM, Clinical Manager 1 indicated the order for therapy visit frequency was missed by the OT. 2. Clinical record review for patient #14 was completed on 6/27/2023 (start of care 6/02/2023), for certification period 6/02/2023-7/31/2023. Record review evidenced a plan of care, which indicated Speech therapy (ST) visit frequency was ordered for 1 time a week for 2 weeks and then 2 times a week for two weeks. Record review evidenced a coordination note, which indicated ST would be on hold due to the therapist absence. Record review failed to evidence patient’s therapy needs were met. During an interview on 6/02/2023 at 2:24 PM, the RN Educator indicated the speech therapy (ST) was placed on hold because the therapist was a part-time employee and left for a vacation. 3. Clinical record review for patient #17 was completed on 6/28/2023 (start of care 5/16/2023) for certification period 5/16/2023-7/14/2023. Record review evidenced a plan of care, which indicated OT delayed start of care until 5/21/2023 due to the OT and COTA were not available due to a leave of absence. Record review evidenced an order, which indicated home health aide to delay care. Record review failed to evidence patient's therapy needs and personal care needs were met. During an interview on 6/23/2023 at 11:38 AM, Clinical Manager 2 indicated 1 OT was on family medical leave and a COTA was on vacation. There was only 2 other OT's available and they probably had a back log of patients. During an interview on 6/23/2023 at 11:39 AM, RN Educator indicated the agency employed 1 home health aide and she was off for a death in the family. 4. Clinical record review for patient #19 was completed on 6/26/2023 (start of care 6/07/2023), for certification period 6/07/2023-8/05/2023. Record review evidenced a plan of care, which indicated OT delayed start of care until 6/11/2023 due to the OT and COTA were not available due to a leave of absence. Record review failed to evidence patient’s therapy needs were met. During an interview on 6/26/2023 at 2:47 PM, the Administrator indicated a full- time OT and full-time Certified Occupational Therapy Assistant COTA were on a leave of absence. 5. Clinical record review for patient #20 was completed on 6/26/2023 (start of care 5/25/2023), for certification period 5/25/2023-7/23/2023. Record review evidenced a plan of care, which indicated a delay in OT started on 6/04/2023 due the OT and COTA were not available due to leave of absence. Record review failed to evidence patient’s therapy needs were met. During an interview on 6/26/2023 at 2:47 PM, the Administrator indicated a full-time OT and full-time Certified Occupational Therapy Assistant COTA were on a leave of absence. 1. Review of an agency policy dated 4/01/2020, titled "CARE MANAGEMENT AND PLAN OF CARE", stated, "... The agency provides the patient with the services according to the individualized plan of care that is developed ... The individualized plan of care specifies the care and services necessary to meet the needs of the patient ... THE NURSE/THERAPIST ASSIGNED TO ADMIT THE PATIENT ... Contacts the attending physician ... to ... Discuss services and disciplines to be provided, including any services ordered on the referral but not needed, any services not ordered on the referral but recommended, or any services refused by the patient ... For therapy-only cases, the therapist requests a physician order for 1 or more nursing visit(s) if the needed [sic] for medication management/instruction if needed or has care needs which are not within the therapist's scope of practice ...." 2. Review of an agency policy with review date 9/01/2022, titled, "ASSESSMENT/REASSESSMENT", stated, "... Assessments and reassessments are done by THAH [Entity 1, corporate owner of agency] to determine the care and services needed by the patient ... The initial assessment determines the need for care/services ..." 3. Review of an agency document dated 6/08/2023, titled "Saint Joseph VNA Home Care Colleagues List", evidenced the agency only employed 1 Speech Language Pathologist (SLP), and 1 Home Health Aide (HHA). 4. Clinical record review for Patient #2 was completed on 6/27/2023, start of care date 5/22/2023. Record review evidenced an initial plan of care. The document evidenced Occupational Therapy (OT) was ordered upon admission, but failed to evidence OT was provided, or if the patient refused OT services. During an interview on 6/27/2023 at 2:33 PM, the Registered Nurse (RN) Educator indicated the patient was hospitalized on 5/25/2023, and maybe that's why OT didn't see the patient. 5. A home visit was observed with Patient #3 and OT 3 on 6/20/2023 at 9:30 AM. The patient reported her weight on that day was 185 pounds, she lost 90 pounds since September 2022, she wasn't trying to lose weight, she received 10 and a half units of blood since Christmas (2022), she had a hematologist who monitored her blood hemoglobin levels (a lab test to determine red blood cell count, and low hemoglobin levels could be caused by bleeding, anemia [low red blood cell count], or other diseases), her most recent result (2 weeks ago per the patient) was 9.7 (normal range for women is range for women is 12.0 to 15.5), and she was going today to get her blood drawn (to test her hemoglobin level). The patient also indicated she had a pulmonary function test (a test to determine how effective the lungs work) on 6/08/2023, a TEE Watchman Check (a transesophageal echocardiogram or TEE, which takes pictures of the heart to make sure there are no blood clots and to measure the size of the left atrial appendage) on 6/09/2023, and an endoscopy (a procedure to look inside the body) on 6/12/2023. OT 3 reviewed a list of medications the patient provided and compared it to the agency's list of medications, and confirmed there were several discrepancies. Clinical record review for Patient #3 was completed on 6/27/2023, start of care date 5/27/2023. Review of the initial comprehensive assessment completed on 5/27/2023 evidenced PT performed the assessment, the patient's weight was 200 pounds, Physical Therapy (PT) and OT were the only "reasonable and necessary" disciplines recommended, had multiple risks for hospitalization, the patient was experiencing high health risks, and referred for home health after hospitalization with discharge on 6/25/2023, for gastrointestinal (GI) bleeding, anemia, and UTI. The document also evidenced the patient had diagnoses of diabetes and heart failure, the PT discussed it with the patient, the patient denied having either diagnosis, and the PT instructed the patient to talk about it with her doctor; and failed to evidence nursing services was recommended as reasonable and necessary to address the patient's "high health risks", or current medical concerns. Record review evidenced subsequent therapy visit notes, which evidenced the patient's weight was 197 pounds on 5/30/2023, 196 pounds on 6/02/2023, 192 pounds on 6/05/2023, and 185 pounds on 6/20/2023 (15 pound weight loss in 24 days). During an interview on 6/20/2023 at 3:43 PM, the Administrator indicated the physician only ordered PT and OT. During an interview on 6/20/2023 at 3:50 PM, Clinical Manager 1 indicated nursing services should be on the case for the Patient. 6. Clinical record review for Patient #4 was completed on 6/27/2023 (start of care date 3/27/2023, certification period 3/27/2023 - 5/25/2023). Record review evidenced a coordination note dated 5/02/2023, which indicated the patient was hospitalized on 5/02/2023 for a scheduled hip revision surgery on 5/03/2023, anticipated discharge date was 5/04/2023, and resumption of care orders included PT, OT, and Home Health Aide (HHA) services. Record review evidenced a resumption of care physician's order dated 5/08/2023, which indicated orders for PT to perform/teach wound care to the left hip incision. Record review evidenced a resumption of care visit was completed by a PT on 5/08/2023, which evidenced the patient had a dressing over the post-surgical left hip incision, the patient's family member managed the incision care/dressing changes, the PT didn't assess the incision, or provide any education of the care needed to the incision; a Medical Social Worker (MSW) was added to assist with long-term planning, and failed to evidence if the patient was offered and/or refused Nursing, OT, or HHA services. Record review failed to evidence any other visits were made after 5/08/2023, and a communication note dated 5/11/2023 evidenced the patient was re-hospitalized on 5/11/2023 for drainage to the surgical site (left hip). Record review evidenced a physician order to re-schedule the MSW visit during the week of 5/14/2023, but failed to evidence why the visit re-schedule request was made. Record review failed to evidence any MSW visit(s) were provided. Record review evidenced a resumption of care visit was completed by a PT on 5/15/2023, after the patient's hospitalization for seroma (a mass or lump caused by a buildup of clear fluid in a tissue, organ, or body cavity) and excessive drainage to the left surgical hip. The document evidenced the patient had a Prevena (brand name) negative pressure wound treatment (NPWT) device (a portable, disposable system, which uses negative pressure [like a vacuum] to help heal and protect the incision, to be managed only by qualified clinical professionals) in place to the left hip incision. Record review failed to evidence any education/care, and/or treatment/precaution orders for the use of the Prevena NPWT device, and failed to evidence any additional visits were made by agency staff. During an interview on 6/27/2023 at 3:47 PM, the Registered Nurse (RN) Educator indicated the patient's 1st hospitalization (5/02/2023) was preplanned for revision of the left hip, and the 2nd hospitalization (5/11/2023, unplanned), was due to drainage from the surgical site. Regarding the resumption of care on 5/15/2023, the RN Educator indicated she assumed the hospital would have trained the patient/family about the management/treatment of the Prevena NPWT device, the use of a Prevena NPWT device didn't require nursing interventions, and they (agency) didn't typically manage those devices. During an interview on 6/27/2023 at 3:54 PM, the Administrator indicated he couldn't explain why no visits were made after the resumption of care that occurred on 5/15/2023, and indicated the patient was transferred into the hospital again on 5/25/2023 for ongoing surgical incision drainage issues. 7. Clinical record review for Patient #5 was completed on 6/29/2023 (start of care date 4/06/2023). Record review evidenced an initial and comprehensive assessment was completed by a PT on 4/06/2023. The document evidenced the patient's primary diagnosis of sepsis (occurs when chemicals are released in the bloodstream to fight an infection, which triggers inflammation throughout the body, and could cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even resulting in death) was poorly controlled and needed frequent adjustments in treatment and dose monitoring; and other diagnoses included hydronephrosis (condition characterized by excess fluid in a kidney due to a backup of urine, caused by a blockage in the tube that connects the kidney to the bladder; possible causes include infection; and symptoms include difficulty urinating and pain in the side, abdomen, or groin); PT and OT were the only reasonably necessary disciplines recommended, the patient was likely to remain in fragile health and have ongoing high risk(s) of serious complications and death, and the patient and caregiver had knowledge deficits related to pathophysiology (how a disease, injury, or other condition affects a patient, including both the physical and functional changes) of the patient's diagnoses and medications; had shortness of breath, pain (unable to answer what location), poor hydration and appetite, had an ileostomy (an artificial opening in the abdomen to drain feces), was a high nutritional risk, prior to hospitalization/home care services, the patient received intravenous (IV) saline (sterile salt water) infusions twice weekly for the past 2 years, after the ileostomy was created; and family reported the patient sustained an injury to the left elbow (not further detailed) while hospitalized, and was keeping it covered with a bandage. Record review failed to evidence nursing services was added for the complex medical concerns, wound, ileostomy management, or follow up on resumption of IV saline infusions. Record review evidenced an OT visit evaluation dated 4/07/2023. The document evidenced the OT notified the physician for the patient's report of difficulty breathing, anxiousness, and difficulty sleeping; and documented the patient stated "I can't sleep, I feel like I can't breathe." The document failed to evidence the agency's Clinical Manager was notified by the OT to add Nursing services. Record review evidenced an order dated 4/07/2023 at 1:47 PM to add Nursing services to evaluate. Record review failed to evidence a Nursing evaluation was completed on 4/07/2023. Record review evidenced a plan of care for certification period 4/06/2023 - 6/04/2023, which evidenced Skilled Nursing, effective 4/09/2023, was ordered once for 1 week. Record review evidenced an order dated 4/13/2023, which evidenced the patient was admitted to the hospital on 4/07/2023 at 7:01 PM, and discharged on 4/13/2023. Record review evidenced an order dated 4/17/2023, which indicated the patient's hospitalization was for dehydration and acute (sudden) kidney failure, and skilled nursing, PT and OT services were ordered. Record review evidenced PT performed a resumption of care on 4/17/2023, and the RN and OT performed evaluations on 4/21/2023. During an interview on 6/29/2023 at 12:15 PM, Clinical Manager 1 indicated there was a home care order for PT, OT, and Nursing, dated 3/30/2023, and the Administrator indicated there was an order dated 4/05/2023 for PT and OT only, and on 4/07/2023, there was an order to add nursing as well. The Clinical Manager confirmed he obtained the order on 4/07/2023 for the nurse to evaluate, but didn't know why he requested the evaluation. The Administrator indicated 4/07/2023 was a Friday, so it looked like the RN evaluation wasn't scheduled to occur until 4/09/2023. The RN Educator indicated she couldn't say why the nurse didn't go out on the same day (4/07/2023), and didn't know if there was nursing staff available. The Administrator indicated the order on 4/07/2023 for nursing to evaluate was received around 2:00 PM, so maybe we couldn't schedule a nurse, and nurses already had their schedules made for the day. Clinical Manager 1 indicated it was a PT admission, family told the PT about the IV infusions, confirmed there was nothing in the orders to address the infusions, and indicated the agency didn't do peripheral (small vein) IVs. 8. Clinical record review for Patient #7 was completed on 6/29/2023 (start of care 11/27/2022, certification period 5/26/2023 - 7/24/2023). Record review evidenced a coordination note dated 5/26/2023, which indicated the patient received bed baths from a bath aide (HHA), not further specified. Record review evidenced the plan of care indicated the patient was incontinent and bedbound, but failed to include the agency provided HHA services. During an interview on 6/29/2023 at 1:20 PM, the RN Educator indicated privately paid HHA services was provided by Entity 7 (a home health agency), and it was documented in the start of care summary (11/27/2022). 9. A home visit was observed with Patient #9 on 6/20/2023 at 11:30 AM. Clinical Manager 1 and Licensed Practical Nurse (LPN) 1 were present. Prior to entering the home, Clinical Manager 1 indicated there was a suspected bedbug infestation in the home, and he was unaware until today. Once in the home, the patient presented alert and oriented, lying on his bed in the living room, and the bed linens were visibly soiled; the bed and floor had innumerable live and dead bedbugs on it, the home had a very foul odor, and there were urinals with urine in them sitting on furniture; the patient's skin and hair was visibly dirty, was clothed only in a soiled t-shirt, a soiled brief, and soiled socks. LPN 1 indicated she was supposed to fill the medication pill planner every week, confirmed there were no current medications in the home to fill the medication planner, and this was not a new problem. LPN 1 assisted the patient to a sitting position, and removed the patient's socks. The patient's feet were dirty, there was unidentifiable black/brown matter between the toes, and all toenails were long and jagged. The patient requested to have his toenails cut. LPN 1 indicated she wasn't allowed to cut toenails, and failed to offer assistance with personal hygiene care during the visit. Clinical Manager 1 indicated maybe he could find someone at Entity 8 (community services organization for older adults) to cut the toenails. Clinical record review for Patient #9 was completed on 6/20/2023, 6/21/2023, 6/27/2023, and 6/29/2023 (start of care 3/30/2023). Record review of a document from Entity 9, dated 5/02/2023, titled "Nursing Home Visit", evidenced the patient was discharged from the hospital to home on 3/29/2023, then readmitted on 3/30/2023, "because of the inability to care for himself at home". Record review of a document from Entity 9 (a skilled nursing facility), dated 5/22/2023, evidenced the patient would discharge to home, with orders to resume home care, with PT, OT, and MSW. Record review of an untitled document from Entity 9, dated 5/24/2023, evidenced the patient would discharge to home on 5/25/2023. Record review evidenced the RN didn't provide a visit until 5/31/2023 (6 days after discharge), and OT services were delayed (not further specified), and the evaluation visit occurred on 6/11/2023 (17 days after discharge). Record review evidenced a physician order, effective date 6/04/2023, for MSW to evaluate (not further specified), and referral to Adult Protective Services (APS) recommended (not further specified). Record review evidenced a physician order dated 6/07/2023, which stated "... MSW assessment has been cancelled as APS has been notified twice regarding patient's living conditions. The case workers from APS will be handling any patient care needs ...." Record review evidenced the initial MSW evaluation was made on 6/23/2023 (29 days after discharge). During an interview on 6/21/2023 at 2:23 PM, the Administrator indicated the agency didn't have a policy for trimming toenails, but it’s their practice that clinicians do not clip toenails, and the OT was delayed due to the COTA had COVID-19, and the OT was on FMLA; Clinical Manager 2 indicated they previously attempted to secure home medication delivery with pre-filled containers, she called Person 10 (patient's certifying physician) on 6/5/2023 to request this, and Person 10's staff informed Clinical Manager 2 the patient needed to come in to see the doctor to discuss it further, and the patient hasn't been to the clinic since prior to the hospitalization in March (2023). The Administrator indicated Person 10 wasn't willing to sign orders for the patient at this time since the patient hasn't been seen, and technically the agency shouldn’t be providing services if they don’t have a physician. Clinical Manager 1 indicated he called APS after the home visit on 6/20/2023 to file a new concern, APS won't tell them anything about what is done on their end, and confirmed the agency hasn't sent a HHA or RN to assess the patient. The RN educator asked if Entity 8 was involved for transportation needs. Clinical Manager 1 indicated the patient can't go anywhere unless someone takes him. The RN Educator indicated if APS closes its case, the agency could get their social worker involved. Clinical Manager 2 indicated they could reach out to Entity 9 to see if their MSW bothered to make any referrals, and MSW 1 told her the agency couldn't see the patient if APS was involved; and Clinical Manager 2 indicated since the clinicians had already contacted APS, there really wasn’t much more the agency could do. During an interview on 6/22/2023 at 10:05 AM, MSW 1 stated "... Yes, of course I can be involved [with agency patients] when APS is involved ....", she was not aware of the patient's dire condition, and was actually "quite shocked" to get a call about it yesterday (from the agency); and she sees patients when an order is received, but she didn't previously have an order to see the patient. During an interview on 6/22/2023 at 12:21 PM, Person 11 (APS case worker) indicated he went to the patient's home about 2 or 3 weeks ago, the patient was competent to make his own decisions, and didn't want APS involvement; he received a voicemail from the agency yesterday to report bedbugs, and APS generally followed up with healthcare facilities who made reports. During an interview on 6/27/2023 at 11:46 AM, MSW 1 indicated she felt like this patient did slip through the cracks, and she felt bad about that. 10. Clinical record review for Patient #10 was completed on 6/27/2023 (start of care 4/22/2023). Record review evidenced an initial plan of care (certification period 4/22/2023 - 6/20/2023), which evidenced the patient's primary diagnosis was chronic obstructive pulmonary disease (COPD) with acute (severe and sudden onset) exacerbation (increase in symptom intensity), and additional diagnoses included asthma, acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions), and hyperglycemia (high blood sugar levels); the patient required continuous supplemental oxygen (O2), PT performed the initial evaluation/comprehensive assessment, and nursing was ordered to begin weekly after the start of care visit, with 3 "as needed" visits for changes in condition. Record review evidenced the initial comprehensive assessment was completed 4/22/2023. The document evidenced the patient's COPD was poorly controlled, and the patient needed frequent adjustments in treatments and dose monitoring; PT was the only discipline recommended as reasonable and necessary; the patient lived alone, had occasional short-term assistance for transportation and shopping, and needed help with personal care; the primary home care focus was shortness of breath, and the PT observed the patient not wearing O2 upon arrival because she couldn't switch the O2 cylinders, assessed the patient's oxygen (O2) saturation was 80% (88% - 92% O2 level is considered safe for someone with moderate to severe COPD, levels below 88% become dangerous, and any level 80% or lower is dangerous for the vital organs and needs urgent treatment), and after the PT switched the cylinders and administered O2, the patient's O2 level increased to 96%. Record review failed to evidenced an "as needed" nursing visit was made to address the patient's respiratory status, or to ensure safe and appropriate use of O2. Record review evidenced a nursing evaluation was performed 3 days later, on 4/25/2023. During an interview on 6/27/2023 at 4:12 PM, the Administrator confirmed the home care referral ordered both PT and Nursing services, and he didn't know why PT did the initial visit; Clinical Manager 1 indicated Nursing should have performed the initial assessment/comprehensive assessment, so the O2 issue could have been dealt with right away, but during that time period, they were still under the COVID-19 waiver, they probably didn't have the staff for nursing, and they took advantage of the waiver to allow therapy to open all cases; and the RN Educator indicated it was better to start cases sooner than later. 11. During an interview on 6/08/2023, the RN Educator indicated staffing the patients has been an issue. 12. During an interview on 6/21/2023 at 4:30 PM, the RN Educator confirmed the agency employed only 1 HHA, and Clinical Manager 2 indicated MSW 1 was the only MSW, and she was PRN (as needed)/part time. 13. During an interview on 6/26/2023 at 2:47 PM, the Administrator indicated they were working on therapists identifying the need for nursing services; one of 2 full time OTs (OT 2) was on family medical leave 5/01/2023 through end of July (2023); and the agency's only Certified Occupational Therapist Assistant (COTA) was on paid time off (PTO) 5/26/2023 – 06/02/2023, then off again 6/05/2023 - 6/09/2023 for COVID-19. The Administrator indicated they still needed to provide care to current patients, they gave patients the option to pick another agency if needs couldn't be met, and it would be documented in an order.

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 all patients had individualized vital sign parameters specific to their needs for 20 of 20 clinical records reviewed (Patient #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20). The findings include: 1. Record review of an agency policy, review date 12/09/2021, titled “CARE MANAGEMENT AND PLAN OF CARE”, stated, “... The individualized plan of care specifies the care and services necessary to meet the needs of the patient identified in the comprehensive assessment and addresses the following ....“ 2. Clinical record review for Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20, all evidenced the same vital signs (temperature, pulse, respirations, blood pressure, and oxygen saturation level) parameters for which the Physician should be notified: temperature less than 96.5 degrees Fahrenheit or greater than 100.9 degrees Fahrenheit, pulse less than 50 beats per minute or greater than 110 beats per minute, respirations less than 12 per minute or greater than 25 per minute, systolic blood pressure less than 90 or greater than 170, diastolic blood pressure less than 50 or greater than 94, and oxygen saturation less than 90%. Record reviews failed to ensure vital signs parameters were individualized to each patient as recommended by the ordering physician. During an interview on 6/26/2023 at 11:50 AM, the Registered Nurse (RN) Educator indicated the vital signs parameters ranges were generated in the plans of care by default by the electronic medical record (EMR) software.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the patient's plan of care included all required elements, for 13 of 20 clinical records reviewed. (Patient #1, 2, 3, 4, 5, 7, 10, 11, 12, 14, 15, 17, 19, 20). The findings include: 8. Clinical record review for Patient #1 was completed on 6/27/2023 (start of care date 2/11/2023). Record review evidenced a comprehensive reassessment dated 4/10/2023. The document evidenced the patient required "special transportation" (not further specified), family administered all medications, the patient used ice/heat for pain management, caregiver monitored blood sugar levels "usually daily", and was dependent for all personal care. Record review evidenced a plan of care for certification period 4/12/2023 - 6/10/2023, which evidenced the patient's medications included percocet (a narcotic pain reliever, which could cause constipation), required a diabetic and high protein diet, and skilled nursing interventions included teaching on increased protein intake, but failed to include a measurable outcome/goal for increased protein intake; evidenced the patient/caregiver to monitor blood glucose twice daily, failed to evidence the caregiver monitored "usually daily", and failed to evidence interventions or measurable outcomes/goals for compliance with blood glucose monitoring; failed to include treatment orders for ice/heat; and failed to evidence all of the patient's psychosocial needs. During an interview on 6/27/2023 at 1:58 PM, Clinical Manager 1 indicated he would expect education for mitigation of constipation for the use of Percocet, family provided all care to the patient; and Clinical Manager 1 and the Administrator both indicated the use of heat and ice should be on the plan of care. 9. Clinical record review for Patient #2 was completed on 6/27/2023, start of care date 5/22/2023. Record review evidenced an initial plan of care, which evidenced the patient had caregivers come in multiple times per week to assist them; the patient reported severe pain to her abdomen, wanted to resume use of narcotic pain relievers, and was going to talk to her pain management specialist; and a skilled nursing intervention to monitor and mitigate pain; but failed to evidence who the caregivers were, or what assistance they provided to meet the patient's needs, a patient-specific pain goal, a measurable outcome/goal for pain, or who the pain management specialist was. During an interview on 6/27/2023 at 2:33 PM, the Registered Nurse (RN) Educator indicated the plan of care didn't specify what the caregivers did, and Clinical Manager 1 indicated the plan of care didn't list who the pain management specialist was. 10. A home visit was observed with Patient #3 and Occupational Therapist (OT) 3 on 6/20/2023 at 9:30 AM. The patient reported she lost 90 pounds since September 2022, she wasn't trying to lose weight, she received 10 and a half units of blood since Christmas (2022), she had a hematologist who monitored her blood hemoglobin levels (a lab test to determine red blood cell count, and low hemoglobin levels could be caused by bleeding, anemia [low red blood cell count], or other diseases), her most recent result (2 weeks ago per the patient) was 9.7 (normal range for women is range for women is 12.0 to 15.5), and she was going today to get her blood drawn (to test her hemoglobin level). Record review evidenced a plan of care (certification period 5/27/2023 - 7/25/2023), which evidenced the patient's primary diagnosis was gastrointestinal (GI) hemorrhage (blood loss from any of the several organs included in your digestive system); and other diagnoses included acute post-hemorrhagic anemia, atrial fibrillation (irregular heart beats), heart failure, diabetes, and urinary tract infection (UTI); and risks for hospitalization included obesity and difficulty complying with any medical instructions. The plan of care failed to evidence patient-specific interventions and measurable outcomes/goals for primary and other pertinent diagnoses or risks for hospitalization; or information for the patient's hematologist, how often the patient's blood levels were monitored, or interventions/goals to monitor/mitigate the patient's 90 pound unplanned weight loss. During an interview on 6/20/2023 at 3:43 PM, the Administrator indicated the physician only ordered Physical Therapy (PT) and Occupational Therapy (OT), and the medical concerns wouldn't be handled by therapy. 11. Clinical record review for Patient #4 was completed on 6/27/2023 (start of care date 3/27/2023, certification period 3/27/2023 - 5/25/2023). Record review evidenced a coordination note dated 5/02/2023, which indicated the patient was hospitalized on 5/02/2023 for a scheduled hip revision surgery on 5/03/2023, anticipated discharge date was 5/04/2023, and resumption of care orders included PT, OT, and Home Health Aide (HHA) services. Record review evidenced a resumption of care physician's order dated 5/08/2023, which indicated orders for PT to perform/teach wound care to the left hip incision, and provide incision care, but failed to evidence the ordered frequency for incision care. Record review evidenced a resumption of care visit was completed by a PT on 5/15/2023, after the patient's hospitalization for seroma (a mass or lump caused by a buildup of clear fluid in a tissue, organ, or body cavity) and excessive drainage to the left surgical hip. The document evidenced the patient had a Prevena (brand name) negative pressure wound treatment (NPWT) device (a portable, disposable system, which uses negative pressure [like a vacuum] to help heal and protect the incision, to be managed only by qualified clinical professionals) in place to the left hip incision. Record review failed to evidence any education/care, and/or treatment/precaution for the use of the Prevena NPWT device on the updated plan of care. During an interview on 6/27/2023 at 3:47 PM, the Registered Nurse (RN) Educator indicated the patient's 1st hospitalization (5/02/2023) was preplanned for revision of the left hip, and the 2nd hospitalization (5/11/2023, unplanned), was due to drainage from the surgical site. Regarding the resumption of care on 5/15/2023, the RN Educator indicated she assumed the hospital would have trained the patient/family about the management/treatment of the Prevena NPWT device, the use of a Prevena NPWT device didn't require nursing interventions, and they (agency) didn't typically manage those devices. 12. Clinical record review for Patient #5 was completed on 6/29/2023 (start of care date 4/06/2023). Record review evidenced an initial and comprehensive assessment was completed by a PT on 4/06/2023. The document evidenced the patient's primary diagnosis of sepsis (occurs when chemicals are released in the bloodstream to fight an infection, which triggers inflammation throughout the body, and could cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even resulting in death) was poorly controlled and needed frequent adjustments in treatment and dose monitoring; and other diagnoses included hydronephrosis (condition characterized by excess fluid in a kidney due to a backup of urine, caused by a blockage in the tube that connects the kidney to the bladder; possible causes include infection; and symptoms include difficulty urinating and pain in the side, abdomen, or groin); the patient was likely to remain in fragile health and have ongoing high risk(s) of serious complications and death, and the patient and caregiver had knowledge deficits related to pathophysiology (how a disease, injury, or other condition affects a patient, including both the physical and functional changes) of the patient's diagnoses and medications; had shortness of breath, pain (unable to answer what location), poor hydration and appetite, had an ileostomy (an artificial opening in the abdomen to drain feces), was a high nutritional risk, prior to hospitalization/home care services, the patient received intravenous (IV) saline (sterile salt water) infusions twice weekly for the past 2 years, after the ileostomy was created; and family reported the patient sustained an injury to the left elbow (not further detailed) while hospitalized, and was keeping it covered with a bandage. Record review evidenced a plan of care for certification period 4/06/2023 - 6/04/2023, which failed to evidence interventions or measurable outcomes/goals for all problems addressed on the comprehensive assessment. During an interview on 6/29/2023 at 12:15 PM, Clinical Manager 1 indicated it was a PT admission, family told the PT about the IV infusions, and confirmed there was nothing in the orders to address the infusions. 13. Clinical record review for Patient #7 was completed on 6/29/2023 (start of care 11/27/2022, certification period 5/26/2023 - 7/24/2023). Record review evidenced a coordination note dated 5/26/2023, which indicated the patient received bed baths from a bath aide (HHA), not further specified. Record review of the plan of care evidenced the patient was incontinent and bedbound, but failed to evidence how the patient's personal care needs were met. During an interview on 6/29/2023 at 1:20 PM, the RN Educator indicated privately paid HHA services was provided by Entity 7 (a home health agency), and it was documented in the start of care summary (11/27/2022). 14. A home visit was observed with Patient #9 on 6/20/2023 at 11:30 AM. Clinical Manager 1 and Licensed Practical Nurse (LPN) 1 were present. Prior to entering the home, Clinical Manager 1 indicated there was a suspected bedbug infestation in the home, and he was unaware until today. Once in the home, the patient presented alert and oriented, lying on his bed in the living room, and the bed linens were visibly soiled; the bed and floor had innumerable live and dead bedbugs on it, the home had a very foul odor, and there were urinals with urine in them sitting on furniture; the patient's skin and hair was visibly dirty, was clothed only in a soiled t-shirt, a soiled brief, and soiled socks. LPN 1 indicated she was supposed to fill the medication pill planner every week, confirmed there were no current medications in the home to fill the medication planner, and this was not a new problem. LPN 1 assisted the patient to a sitting position, and removed the patient's socks. The patient's feet were dirty, there was unidentifiable black/brown matter between the toes, and all toenails were long and jagged. The patient requested to have his toenails cut. LPN 1 indicated she wasn't allowed to cut toenails, and failed to offer assistance with personal hygiene care during the visit. Clinical Manager 1 indicated maybe he could find someone at Entity 8 (community services organization for older adults) to cut the toenails. Clinical record review for Patient #9 was completed on 6/20/2023, 6/21/2023, 6/27/2023, and 6/29/2023 (start of care 3/30/2023). Record review of a document from Entity 9, dated 5/02/2023, titled "Nursing Home Visit", evidenced the patient was discharged from the hospital to home on 3/29/2023, then readmitted on 3/30/2023, "because of the inability to care for himself at home". Record review of an untitled document from Entity 9, dated 5/24/2023, evidenced the patient would discharge to home on 5/25/2023. Record review of the plan of care failed to evidence the patient's psychosocial needs, or how the patient's personal care needs were met. During an interview on 6/21/2023 at 2:23 PM, the Administrator indicated the agency didn't have a policy for trimming toenails, but it’s their practice that clinicians do not clip toenails. Clinical Manager 2 indicated they previously attempted to secure home medication delivery with pre-filled containers, she called Person 10 (patient's certifying physician) on 6/5/2023 to request this, and Person 10's staff informed Clinical Manager 2 the patient needed to come in to see the doctor to discuss it further, and the patient hasn't been to the clinic since prior to the hospitalization in March (2023). The Administrator indicated Person 10 wasn't willing to sign orders for the patient at this time since the patient hasn't been seen, and technically the agency shouldn’t be providing services if they don’t have a physician. The RN educator asked if Entity 8 was involved for transportation needs. Clinical Manager 1 indicated the patient can't go anywhere unless someone takes him. The RN Educator indicated if APS closes its case, the agency could get their social worker involved. Clinical Manager 2 indicated they could reach out to Entity 9 to see if their MSW bothered to make any referrals, and MSW 1 told her the agency couldn't see the patient if APS was involved; and Clinical Manager 2 indicated since the clinicians had already contacted APS, there really wasn’t much more the agency could do. 15. Clinical record review for Patient #10 was completed on 6/27/2023 (start of care 4/22/2023). Record review evidenced the initial comprehensive assessment was completed 4/22/2023. The document evidenced the patient's chronic obstructive pulmonary disease (COPD) was poorly controlled, and the patient needed frequent adjustments in treatments and dose monitoring; PT was the only discipline recommended as reasonable and necessary; the patient lived alone, had occasional short-term assistance for transportation and shopping, and needed help with personal care; the primary home care focus was shortness of breath, and the PT observed the patient not wearing O2 upon arrival because she couldn't switch the O2 cylinders, assessed the patient's oxygen (O2) saturation was 80% (88% - 92% O2 level is considered safe for someone with moderate to severe COPD, levels below 88% become dangerous, and any level 80% or lower is dangerous for the vital organs and needs urgent treatment), and after the PT switched the cylinders and administered O2, the patient's O2 level increased to 96%. Record review evidenced an initial plan of care (certification period 4/22/2023 - 6/20/2023), which evidenced the patient's primary diagnosis was COPD with acute (severe and sudden onset) exacerbation (increase in symptom intensity), and additional diagnoses included asthma, acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions), and hyperglycemia (high blood sugar levels); and the patient required continuous supplemental oxygen (O2). The plan of care failed to evidence interventions and measurable outcomes/goals for the problems identified on the comprehensive assessment, or the patient's problematic diagnoses. During an interview on 6/27/2023 at 4:12 PM, the Administrator confirmed the home care referral ordered both PT and Nursing services, and he didn't know why PT did the initial visit; Clinical Manager 1 indicated Nursing should have performed the initial assessment/comprehensive assessment, so the O2 issue could have been dealt with right away, but during that time period, they were still under the COVID-19 waiver, they probably didn't have the staff for nursing, and they took advantage of the waiver to allow therapy to open all cases; and the RN Educator indicated it was better to start cases sooner than later. Record review of an agency document titled “Care Management and Plan of care” last reviewed by agency on 12/09/2021, stated, “The individualized plan of care specifies the care and services necessary to meet the needs of the patient identified in the comprehensive assessment and addresses the following: All pertinent diagnoses, Mental, psychosocial, and cognitive status, types of services, supplies and equipment required … Patient-specific interventions and education ….“ 1. Clinical record review for patient #11 was completed on 6/28/2023 (start of care 4/30/2023) for certification period 4/30/2023-6/28/2023. Record review evidenced a plan of care, which indicated the patient was a high nutritional risk. Review of the plan of care failed to evidence goals and interventions related to the nutritional risk. During an interview on 6/26/2023 at 1:13 PM, the RN Educator indicated when a nutritional risk was identified a goal should be correlated to identified risk. 2. Clinical record review for patient #12 was completed on 6/28/2023 (start of care 6/03/2023) for certification period 6/03/2023- 8/01/2023. Record review evidenced a plan of care, which indicated the patient’s primary diagnosis of diabetes (abnormal blood sugars). Review of the plan of care failed to evidence goals and interventions related to diabetes. During an interview on 6/9/2023 at 10:30 AM, Clinical Manager 1 indicated the plan of care is based on the hospital records, physician orders and what the staff see in the home. 3. Clinical record review for patient #14 was completed on 6/27/2023 (start of care 6/02/2023), for certification period 6/02/2023-7/31/2023. Review of the plan of care, which indicated the patient demonstrated poor hydration and poor appetite and indicated high nutritional risk. Review of the plan of care failed to evidence interventions and goals based on the high nutritional risk. During an interview on 6/26/2023 at 1:13 PM, the RN Educator indicated when a nutritional risk was identified a goal should be correlated to identified risk. 4. Clinical record review for patient #17 was completed on 6/28/2023 (start of care 5/16/2023) for certification period 5/16/2023-7/14/2023. Review of the plan of care, which indicated the durable medical equipment in the home were wound care supplies and negative pressure wound supplies, bedside commode, wheelchair. During a home visit on 6/19/2023 at 2:24 PM, patient #17 indicated the home is equipped with a stair lift, ramp out of the home, knee scooter. Patient #17 also indicated the use of a transportation van service to get to appointments. Review of the plan of care failed to indicate patient’s need for assistance with transportation. Review of the plan of care failed to indicate a complete list of the medical equipment in the home. During an interview on 6/26/2023 at 1:29 PM, RN Educator indicated the plan of care would indicate transportation needs under the homebound status. During an interview on 6/9/2023 at 10:30 AM, Clinical Manager 1 indicated the plan of care is based on the hospital records, physician orders and what the staff see in the home. 5. Clinical record review for patient #19 was completed on 6/26/2023 (start of care 6/07/2023), for certification period 6/07/2023-8/05/2023. Review of the plan of care, which indicated the patient was a moderate nutritional risk. Review of the plan of care failed to evidence interventions and goals based on indicated moderate nutritional risk for patient. During an interview on 6/26/2023 at 1:13 PM, the RN Educator indicated when a nutritional risk was identified a goal should be correlated to identified risk. 6. Clinical record review for patient #20 was completed on 6/26/2023 (start of care 5/25/2023), for certification period 5/25/2023-7/23/2023. Review of the plan of care, which indicated the patient needed transportation assistance to dialysis appointments and used of assistance devices of cane and wheeled walker. Review of the plan of care, which indicated patient had a diagnosis of diabetes (abnormal blood sugars) and insulin (used to lower level of sugar in the blood). During an observation on 6/22/2023 at 11:17 AM, patient had a caregiver for personal care and transportation assistance in the home. Patient had a bedside commode, and a bed rail was noted on patient bed frame. Record review failed to indicate use of personal caregiver, bedside commode, bed rail, and diabetic goals. Record review and observation failed to evidence patient’s plan of care was individualized to meet the needs of the patient. During an interview on 6/09/2023 at 3:04 PM, Clinical Manager 1 indicated the plan of care is created with physician orders and services provided during a team meeting. During an interview on 6/26/2023 at 1:05 PM, the administrator indicated the plan of care are specific to patient’s needs.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to promptly alert the physician of changes in the patient’s condition, for 6 of 20 clinical records reviewed (Patient #2, 10, 13, 14, 18, 19). The findings include: Review of an agency document titled " Care Management and Plan of Care, " with a last review date of 12/09/2021, stated " During an episode of care, clinicians notify the physician about condition changes, and make physician-ordered changes to the plan of care … When there is an unanticipated change in the patient's condition, the physician is notified … contacts the attending physician whenever the patient has: condition changes, including Significant Change in Condition, … new medications and problems are noted to such as interactions or duplication … values outside of the parameters established by the physician. " Clinical record review for patient #13 was completed on 6/28/2023 (start of care 5/17/2023) for certification period 5/17/2023-7/15/2023. Record review evidenced a plan of care, which indicated a diagnosis of acute on chronic diastolic congestive heart failure and for md notification of weight gain greater than 3 pounds(lb.) in 24 hours. On 5/17/2023 patient weight was 288 lb. and on 5/19/2023 patient weight was 296 lb., which is an 8 lb. weight gain in 48 hours. Record review evidenced of a plan care, which indicated to notify physician of a temperature below 6.5 degrees Fahrenheit. Record review of a nurse note, which indicated the patient had a temperature of 96.0 degrees Fahrenheit. Record review failed to evidence physician notification of patient weight gain and temperature. During an interview on 6/28/2023 at 2:44 PM, Clinical Manager 1 indicated physician notification of the weight gain was not documented. During an interview on 6/28/2023 at 2:48PM, the Administrator indicated the nurse’s documentation did not indicate the physician notified of the abnormal temperature. *Clinical record review for Patient #2 was completed on 6/27/2023, start of care date 5/22/2023. Record review evidenced an initial comprehensive assessment dated 5/22/2023. The document evidenced the patient's primary diagnosis was intestinal obstruction, not specified if partial or complete, and had abdominal pain almost constantly, current pain level was "7" (0-10 pain scale, with 0= no pain, and 10= worst pain imaginable), Record review evidenced a Physical Therapy (PT) evaluation visit note dated 5/24/2023. The document evidenced the patient reported a pain level of "8-9" in the lower back and abdomen, had nausea, and was unable to perform transfers nor walk due to the severe pain. The document evidenced the PT notified the physician regarding the therapy plan of care, but failed to evidence the physician was notified for the severe pain or inability to transfer/ambulate. During an interview on 6/27/2023 at 2:33 PM, Clinical Manager 1 confirmed that on 5/25/2023 at 7:00 PM or so, the patient was seen in the Emergency Department and subsequently hospitalized for acute abdominal pain and nausea/vomiting. * Clinical record review for Patient #10 was completed on 6/27/2023 (start of care 4/22/2023). Record review evidenced an initial plan of care (certification period 4/22/2023 - 6/20/2023), which evidenced the patient's primary diagnosis was chronic obstructive pulmonary disease (COPD) with acute (severe and sudden onset) exacerbation (increase in symptom intensity), and additional diagnoses included asthma, acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions), and hyperglycemia (high blood sugar levels); and the patient required continuous supplemental oxygen (O2). Record review evidenced the initial comprehensive assessment was completed by a PT on 4/22/2023. The document evidenced the patient's COPD was poorly controlled, and the patient needed frequent adjustments in treatments and dose monitoring; the primary home care focus was shortness of breath, the PT observed the patient not wearing oxygen (O2) upon arrival because she couldn't switch the O2 cylinders, assessed the patient's O2 saturation was 80% (88% - 92% O2 level is considered safe for someone with moderate to severe COPD, levels below 88% become dangerous, and any level 80% or lower is dangerous for the vital organs and needs urgent treatment), and after the PT switched the cylinders and administered O2, the patient's O2 level increased to 96%. The document failed to evidence the PT notified the physician. Record review evidenced a plan of care for certification period 4/22/2023 - 6/20/2023, which evidenced orders for the clinician to notify the physician for O2 saturation less than 90%. During an interview on 6/27/2023 at 4:12 PM, the RN Educator indicated the electronic medical record (EMR) probably didn't trigger the PT to notify the physician because she only put the 96% O2 saturation in the vital signs section, and if the PT entered the 80%, the EMR would have triggered it. 7. Clinical record review for patient #12 was completed on 6/28/2023 (start of care 6/03/2023) for certification period 6/03/2023- 8/01/2023. Record review for initial plan of care evidenced the patient’s primary diagnosis was type 2 diabetes with hyperglycemia (abnormally high blood sugar levels); and other pertinent diagnoses included paroxysmal atrial fibrillation (irregular heartbeat), hypertension (high blood pressure), Polymyalgia Rheumatica (joint pain and stiffness), UTI, and hyperlipidemia (high blood cholesterol). Record review indicated the patient was to check blood sugars three times a day and blood sugar parameter between 100-200 milligrams per decaliter (mg/dL). Record review of the initial comprehensive assessment completed on 6/03/2023, evidenced PT performed the assessment. The document evidenced the patient had multiple risk for hospitalization, was referred for home health care. The document failed to evidence the PT assessed heart, lung, or bowel sounds, skin for diabetic ulcer or skin breakdown, or blood sugars within acceptable range. During an interview on 6/26/2023 at 11:34 AM, the Administrator indicated “therapy only” services can address diabetic foot care and interventions.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency's clinicians failed to assure communication with all physicians involved in the plan of care for 2 of 2 clinical records reviewed (Patient # 19, 20). The findings include: 1. Review of an agency document, review date 12/09/2021, titled, "CASE MANAGEMENT AND PLAN OF CARE", stated ". . . During an episode of care, clinicians notify the physician about condition changes, and make physician-ordered changes to the plan of care (in consultation with the patient). When there is an unanticipated change in the patient's condition, the physician is notified ...." 2.Clinical record review for patient #19 was completed on 6/26/2023 (start of care 6/7/2023), for certification period 6/07/2023-8/05/2023. Record review evidenced a plan of care, which indicated patient had home hemodialysis services through a dialysis center Entity 3. Record review failed to evidence coordination of care occurred with the home hemodialysis center Entity 3 and failed to evidence a daily fluid restriction. During an interview on 6/26/2023 at 11:01 AM, the Administrator indicated “therapy only" cases would only coordinate care with dialysis facility only if a problem arose. During an interview on 6/23/2023 at 1:23 PM, patient #19 indicated patient is on a fluid restriction of 1000 milliliters of fluid each day. 3. Clinical record review for patient #20 (start of care 5/25/2023, for certification period 5/25/2023-7/23/2023. Record review evidenced a plan of care which indicated the patient received hemodialysis (removing waste and fluid from blood) services at an outpatient clinic Entity 3. Record review failed to evidence coordination of care occurred between the agency and dialysis center. During an interview with Clinical Manager #2 on 6/23/2023 at 11:25 AM, Clinical Manager #2 indicated the patient recently informed agency staff which days he went to dialysis and therapy visits were scheduled accordingly. During an interview with RN Educator on 6/26/2023 at 2:16 PM, RN Educator indicated that agency documentation did not indicate the name of the dialysis center Entity 3.

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's clinicians failed to coordinate with outside providers for 3 of 3 clinical records reviewed of patients receiving services outside the home health agency. (Patient # 11, 18, 20). The findings include: 1. Review of an agency policy dated 4/01/2020, titled "CARE MANAGEMENT AND PLAN OF CARE, " stated"... CASE COORDINATION AND MANAGEMENT ... The primary case manager regularly coordinates patient care activities with the physician and/or other members of the health care team and documents communications … Agency staff also shares and receives patient information with other providers of care, treatment, or services as needed … to share information and coordinate the care being provided .... " 2. Clinical record review for patient #11 (start of care 4/30/2023), contained a plan of care for the certification period of 4/20/2023-6-/28/2023. The plan of care indicated patient gets care through Entity 4 and wound care through Entity 6. Record review failed to evidence coordination of care occurred between the agency, Entity 4, and wound clinic Entity 6. During an interview on 6/28/2023 at 1:57 PM, Clinical Manager 1 indicated entities should be contacted for coordination of care. At 1:59 PM, Clinical Manager 1 indicated wound care coordination should have occurred with Entity 6. 3. Clinical record review for patient #18 (start of care 6/05/2023), contained a plan of care for the certification period of 6/05/2023-8/03/2023. The plan of care indicated the patient had homemaker and caregiver services through an agency Entity 4. Record review failed to evidence coordination of care occurred between the agency and Entity 4. During an interview on 6/27/2023 at 1:38 PM, Clinical Manager 1 indicated coordination of care should have occurred if the agency was aware of Entity 4 services were in place. 4. Clinical record review for patient #20 (start of care 5/25/2023), contained a plan of care for the certification period of 5/25/2023-7/23/2023. The plan of care indicated the patient’s nursing and caregiver services were provided by a different agency Entity 2 (private duty home health agency). Record review failed to evidence coordination of care between the agency and Entity 2. During an interview on 6/23/2023 at 11:22 AM, Clinical Manager 2 indicated she assumed there was no coordination with other personal services agencies because they were privately paid, the Office Manager indicated they (agency) were supposed to fill out coordination of care paper when other agencies were in the home, and the start of care assessment asks if other agencies were in the home, to include payor source and type of care provided; and the RN Educator indicated to her understanding, coordination of care with privately paid caregivers wasn't required because there’s no chance of double billing.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure it prepared and/or provided all patients with an up-to-date written medication schedule, for 5 of 7 home visits observed (Patient #3, 6, 8, 9, 20). The findings include: 1. Review of an agency policy with effective date 06/29/1992, titled "MEDICATION ADMINISTRATION AND MEDICATION MANAGEMENT", stated, "... SUBSEQUENT VISITS INCLUDE ... ALL DISCIPLINES ... Update the medication profile as needed ... Assessment of the patient on an ongoing basis, including ... other medication-related problems, as well as medication compliance and effectiveness ... Expiration dates are to be checked regularly ...." 2. Review of the agency's "Patient Information Handbook" dated 2016, evidenced a fillable form on page 36 of the booklet, titled "Medication Profile". 3. A home visit occurred with Patient # 3 on 6/20/2023 at 9:30 AM with Occupational Therapist (OT) 3. Review of the patient's home folder failed to evidence an agency-prepared medication list, and page 36 of the Patient Information Booklet was blank. OT 3 reconciled the patient's medications and found several discrepancies with regard to what medications the patient currently took, versus the medications listed in the patient's electronic medical record (EMR) medication profile. During this time, OT 3 indicated family managed the patient's medications. Clinical record review for Patient #3 (start of care date 5/27/2023) evidenced a document (submitted by Clinical Manager 1 on 6/08/2023), titled "Client Medication Report", which stated, "... Meds [medications] Review ... Enter your signature below to acknowledge you have reviewed the medications ...." The document evidenced the last time the medications were reviewed was on 5/31/2023 and was signed by a Registered Nurse (RN). 2. A home visit occurred with Patient # 6 on 6/23/2023 at 9:00 AM. Review of the patient's home folder evidenced the presence of an agency-prepared medication list, printed on 6/21/2023. Licensed Practical Nurse (LPN) 2 reconciled the patient's medications in the home, which failed to match the list dated 6/21/2023. Clinical record review for Patient #6 (start of care 5/05/2023) evidenced a document (submitted by the Office Manager on 6/20/2023), titled "Client Medication Report", evidenced the last time the medications were reviewed was on 5/04/2023. 3. A home visit with Patient # 8 occurred on 6/19/2023 at 10:10 AM with RN 1. RN 1 reconciled the patient's medications, and found several discrepancies with regard to what medications the patient currently took, versus the medications listed in the patient's EMR medication profile. The patient provided a medication list, which evidenced it was printed on 6/16/2023, and indicated Physical Therapist (PT) 2 dropped it off (at the patient's home) on Saturday, 6/17/2023, and she previously had no other list. Clinical Record review for Patient # 8 (start of care date 12/08/2022) evidenced an updated plan of care, which evidenced skilled nursing was the only discipline assigned to the patient, and nursing visits were ordered twice weekly. Review of a document titled "Client Medication Report", evidenced the last time the medications were reviewed was on 6/09/2023. 4. A home visit occurred with Patient # 9 on 6/20/2023 at 11:30 AM with LPN 1. LPN 1 attempted to fill the patient's pill planner, but there were no medications available and indicated that this wasn't a new problem for the hasn't had any medications since he got home from the skilled nursing facility. The patient's home folder evidenced a medication list, which was printed on 6/19/2023. Clinical record review for Patient # 9 (start of care date 3/30/2023), evidenced a resumption of care visit that occurred on 5/28/2023, after the patient's discharge from a skilled nursing facility. Review evidenced a document titled "Client Medication Report", which evidenced the last time the medications were reviewed was on 5/30/2023. 5. A home visit occurred with Patient # 20 on 6/22/2023 at 11:00 AM with Clinical Manager 2. Person 14 (employee of Entity 2, a personal services agency), indicated she administered the patient's medications, and a nurse from Entity 2 came out every Tuesday to fill the patient's pill planner; she couldn't find a home folder for this agency, all folders were kept on a stack on the kitchen counter, but they (Entity 2) went by Entity 2's medication list anyways. 7. During an interview on 6/26/2023 at 11:22 AM, the Administrator indicated a complete medication reconciliation should be done every visit and for therapy visits as well. The Administrator indicated the reconciliation consisted of reviewing all medications in the home, comparing the findings to the agency's medication list, and if inconsistent, the appropriate clinician would call the MD.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure it provided all patients with written information for all treatments administered by the agency, for 7 of 7 home visits observed (Patient #3, 6, 8, 9, 17, 19, 20). The findings include: 1. Review of the agency's "Patient Information Handbook" dated 2016, evidenced fillable forms on pages 38 and 39 titled "Patient Instruction Report", and "Additional items, updates, and changes to Patient's Plan of Care", respectively. 2. A home visit occurred with Patient # 3 on 6/20/2023 at 9:30 AM (start of care date 5/27/2023). Review of the patient's Patient Information Handbook failed to evidence documentation that included all treatments and/or any updated treatments provided by the agency (on pages 38 or 39). 3. A home visit occurred with Patient # 6 on 6/23/2023 at 9:00 AM (start of care date 1/05/2023). The Administrator was also present. Licensed Practical Nurse (LPN) 2 provided wound care to the left lower extremity. Review of the patient's Patient Information Handbook failed to evidence documentation that included all treatments and/or any updated treatments provided by the agency (on pages 38 or 39). 4. A home visit with Patient # 8 occurred on 6/19/2023 at 10:10 AM (start of care date 12/08/2022). Clinical Manager 1 was also present. Registered Nurse (RN) 1 provided wound care. The patient and family both indicated they didn't know where the home folder was, they hadn't seen it in a while, and it was probably upstairs somewhere. The patient indicated the only paperwork she had from the agency was a medication list and signed consent forms, which agency staff just dropped off Saturday (7/17/2023). 5. A home visit occurred with Patient # 9 on 6/20/2023 at 11:30 AM (start of care date 3/30/2023, resumption of care date 5/28/2023). Clinical Manager 1 was also present. Review of the patient's Patient Information Handbook failed to evidence documentation that included all treatments and/or any updated treatments provided by the agency (on pages 38 or 39). 6. A home visit occurred with Patient # 17 on 6/22/2023 at 2:00 PM (start of care 5/16/2023). Clinical Manager 2 was also present. Review of the patient's Patient Information Handbook failed to evidence documentation that included all treatments and/or any updated treatments provided by the agency (on pages 38 or 39). 7. A home visit occurred with Patient # 19 on 6/23/2023 at 12:30 PM (start of care date 6/07/2023). Clinical Manager 2 was also present. Review of the patient's Patient Information Handbook failed to evidence documentation that included all treatments and/or any updated treatments provided by the agency (on pages 38 or 39). 8. A home visit occurred with Patient # 20 on 6/22/2023 at 11:00 AM (start of care date 5/25/2023). Clinical Manager 2 was also present. Person 14 (employee of Entity 2, a personal services agency), looked through a stack of agency folders on the kitchen countertop, indicated they kept all agency folders there, and she didn't have a home folder for this agency. 9. During an interview on 6/23/2023 at 11:43 AM, the RN Educator indicated the initial plan of care was reviewed verbally with the patient, and If there were changes or updates, staff should be writing that in the book (Patient Information Booklet, in the home folder). 10. During an interview on 6/26/2023 at 11:15 AM, the Administrator indicated that with regard to patients not receiving written information for all treatments the agency provided (during review of concerns identified at the home visits), they reached out to Person 10 (National Director of Quality and Services, corporate level, not an agency employee) and Person 3 (Senior Accreditation Manager, corporate level, not an agency employee) who both said it’s in the admission book (Patient Information Booklet) on page 38 (a generic template), and spaces for updates were on page 39, and that was acceptable.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure it showed measurable improvement in falls with major injury; and failed to include complaints in the agency's Quality Assessment Performance Improvement (QAPI) program, to assess processes of care, agency services, and operations (Please see tag G0642); failed to ensure the agency's governing body approved the frequency and detail of the data collection (Please see tag G0644); failed to ensure its performance improvement activities focused on agency-specific high risk, high volume, and/or problem-prone areas (Please see tag G0648); failed to ensure its program activities led to immediate correction of any identified problem that directly and/or potentially threatened the health and safety of patients (Please see tag G0652); failed to take action aimed at performance improvement for the problem prone area of the difficulty staffing nursing services (Please see tag G0656); and failed to ensure performance improvement project(s) documented the reason the agency-specific performance improvement projects were chosen (Please see tag G0658). The findings include: The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure it showed measurable improvement in falls with major injury; and failed to include complaints in the agency's Quality Assessment Performance Improvement (QAPI) program, to assess processes of care, agency services, and operations. The findings include: Review of an agency policy with last review date 6/07/2022, titled "MISSION DRIVEN QUALITY IMPROVEMENT [MDQI]", stated, "... Ongoing quality/performance improvement is addressed using a continuous quality improvement model ... monitoring of staff and client/family concerns, complaints, and unplanned occurrences ...." Review of an agency policy with last review date 09/14/2022, titled "QUALITY IMPROVEMENT PLAN HOME CARE FY [fiscal year] 2023", stated, "... The Quarterly Summary Report Form (QSR) is completed ... to ... Track and trend quality ... Review the progress on ongoing performance improvement activities ... Patient Complaints: The quarterly summary includes trends in the types and numbers of patient concerns and the number or percent of concerns resolved to the patient/caregiver’s satisfaction ... Patient Safety Data includes ... Falls with Major Injury ... Target = 0.64% or less ...." Review of documents received from the Registered Nurse (RN) Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023 ... Patient Experience", evidenced the number of complaints the agency received, but failed to evidence trends in the types and numbers of patient concerns, or the number or percent of concerns resolved to the patient/caregiver’s satisfaction. Review of documents received from the RN Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023", evidenced falls with major injury for the 1st quarter of 2023 was 1.13%, the 2nd quarter was 2.05%, the 3rd quarter was 1.07%, and the target goal was at or below 0.67%. Review of documents received from the RN Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023 ... Safety: Potentially Avoidable Events/Reportable Events", indicated falls with major injury failed to meet the goal for 2 of 3 months in the 1st quarter, failed to meet the goal for 3 of 3 months in the 2nd quarter, and failed to meet the goal for 2 of 3 months in the 3rd quarter. During an interview on 7/11/2023 at 1:22 PM, the RN Educator indicated she was in charge of the QAPI program, in collaboration with the Clinical Managers and the Administrator; and the National Quality Team (not agency employees). The Administrator indicated the RN Educator tracked falls and it was discussed weekly, and the RN Educator indicated the "Beyond Balance Program" wasn't utilized as frequently as should be; and it's coming to end of the agency's fiscal year (FY ending 6/30/2023) review, so based on the number of falls already identified, there might be a new performance improvement project/activity for falls. During an interview on 7/11/2023 at 2:33 PM, the Registered Nurse (RN) Educator indicated complaints were in the Quality Summary Report, but not part of QAPI. 410 IAC 17-12-2(a)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the agency's governing body approved the frequency and detail of the data collection. The findings include: Review of an agency policy dated 8/23/2022, titled "GOVERNANCE: HOME HEALTH BOARD OF DIRECTORS", stated, "... Board of Directors is the Governing Body ... is responsible for ... Approval of the Quality Assessment Performance Improvement program ... overseeing the monitoring of services and the utilization of data for quality improvement efforts ...." During an interview on 7/11/2023 at 1:22 PM, the Registered Nurse (RN) Educator indicated quality indicator data was obtained from from quality reports, home visits, electronic medical record (EMR) software reports, and word of mouth; and she tried to monitor the data every couple of weeks. During an interview on 7/11/2023 at 2:33 PM, the RN Educator and the Administrator both indicated they didn't know if the Governing Body approved the frequency and detail of the data collection. 410 IAC 17-12-2(a)

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure its performance improvement activities focused on agency-specific high risk, high volume, and/or problem-prone areas. The findings include: Review of an agency policy with last review date 09/14/2022, titled "QUALITY IMPROVEMENT PLAN HOME CARE FY [fiscal year] 2023", stated, "... The Quarterly Summary Report Form (QSR) is completed ... to ... Track and trend quality ... Review the progress on ongoing performance improvement activities ... Agency Specific Quality Projects ...." Review of documents received from the Registered Nurse (RN) Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023 ... Agency Specific Quality Projects", indicated the agency had 2 performance improvement projects: Acute Care Hospitalization/30 Day Rehospitalization, and Patient Satisfaction/Willingness to Recommend. During an interview on 6/09/2023 at 10:50 AM, Clinical Manager 1 indicated the agency's performance improvement projects/activities included urinary tract infections (UTIs), wound infections, and he wasn't sure what else; and those areas were chosen based on a large number of patients with urinary catheters, and he also thought skin infections was another performance improvement project. The RN Educator indicated acute care hospitalization was higher than they wanted them to be. During an interview on 7/11/2023 at 1:22 PM, the Registered Nurse (RN) Educator indicated she was in charge of the QAPI program, in collaboration with the Clinical Managers, the Administrator, and the National Quality Team (not agency employees). During an interview on 7/11/2023 at 2:33 PM, the RN Educator indicated the agency had a decent amount of patients with heart failure and chronic obstructive pulmonary disease (COPD). The Administrator indicated they agency serviced a lot of really complicated wound patients from the wound center, he wasn't sure if it was a focus or was addressed as a performance improvement activity, as he just joined the agency last year. The RN Educator indicated she didn't know if it was a focus before.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure its program activities led to immediate correction of any identified problem that directly and/or potentially threatened the health and safety of patients. The findings include: Review of an agency policy with last review date 6/07/2022, titled "MISSION DRIVEN QUALITY IMPROVEMENT [MDQI]", stated, "... Ongoing quality/performance improvement is addressed using a continuous quality improvement model ... monitoring of ... unplanned occurrences ...." Review of an agency policy with last review date 09/14/2022, titled "QUALITY IMPROVEMENT PLAN HOME CARE FY [fiscal year] 2023", stated, "... The Quarterly Summary Report Form (QSR) is completed ... to ... Track and trend quality ... Review the progress on ongoing performance improvement activities ... Patient Safety Data includes ... Falls with Major Injury ... Target = 0.64% or less ...." Review of documents received from the RN Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023", evidenced falls with major injury for the 1st quarter of 2023 was 1.13%, the 2nd quarter was 2.05%, the 3rd quarter was 1.07%, and the target goal was at or below 0.67%. During an interview on 7/11/2023 at 1:22 PM, the RN Educator indicated she was in charge of the QAPI program, in collaboration with the Clinical Managers, the Administrator, and the National Quality Team (not agency employees). The Administrator indicated the RN Educator tracked falls and it was discussed weekly, and the RN Educator indicated the "Beyond Balance Program" wasn't utilized as frequently as should be; and it's coming to end of the agency's fiscal year (FY ending 6/30/2023) review, so based on the number of falls already identified, there might be a new performance improvement project/activity for falls. 410 IAC 17-12-2(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to take action aimed at performance improvement for the problem prone area of the difficulty staffing nursing services. The findings include: Review of an agency policy with last review date 09/14/2022, titled "QUALITY IMPROVEMENT PLAN HOME CARE FY [fiscal year] 2023 [7/01/2022 - 6/30/2023]", stated, "... The Quarterly Summary Report Form (QSR) is completed ... to ... Track and trend quality ... Review the progress on ongoing performance improvement activities ... Agency Specific Quality Projects ...." Review of documents received from the Registered Nurse (RN) Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023 ... Agency Specific Quality Projects", indicated the agency had 2 performance improvement projects: Acute Care Hospitalization/30 Day Rehospitalization, and Patient Satisfaction/Willingness to Recommend. Review of a document received from the RN Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023 ... Acute Care Hospitalization/Emergent Care", evidenced in the 1st quarter, nurse staffing has been a historical issue; the 2nd quarter, nursing staffing continued to be an issue; in the 3rd quarter, the agency continued to wrestle with nursing staffing; and this contributed to the failure to meet the target goal for hospitalization/emergent care. During an interview on 6/08/2023 at 1:32 PM, the RN Educator indicated nursing staffing was an issue. During an interview on 6/09/2023 at 10:50 AM, the RN Educator indicated acute care hospitalization was higher than they wanted them to be. During an interview on 6/26/2023 at 2:42 PM, the Administrator indicated they were working on making sure they assigned the correct staff and correct frequencies to the patients. During an interview on 6/26/2023 at 2:47 PM, the Administrator indicated they were working on therapists identifying the need for nursing services. During an interview on 6/27/2023 at 4:12 PM, the RN Educator indicated in order to start cases sooner than later, they would use Physical Therapists (PTs) to admit the patients. Clinical Manager 1 indicated when they didn't have nursing staff, PT admitted the patients, and when they were still under the COVID-19 waiver, they took advantage of the fact that therapy could open all cases. 410 IAC 17-12-2(a)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure performance improvement project(s) documented the reason the agency-specific performance improvement projects were chosen. The findings include: Review of an agency policy with last review date 09/14/2022, titled "QUALITY IMPROVEMENT PLAN HOME CARE FY [fiscal year] 2023 [7/01/2022 - 6/30/2023]", stated, "... The Quarterly Summary Report Form (QSR) is completed ... to ... Track and trend quality ... Review the progress on ongoing performance improvement activities ... Agency Specific Quality Projects ...." failed to evidence the agency must document the reason the agency-specific performance improvement projects were chosen. Review of documents received from the Registered Nurse (RN) Educator on 7/11/2023, titled "Quarterly Summary Report - Home Care FY 2023 ... Agency Specific Quality Projects", indicated the agency had 2 performance improvement projects: Acute Care Hospitalization/30 Day Rehospitalization, and Patient Satisfaction/Willingness to Recommend. The documents failed to evidence the reason(s) the projects were chosen. During an interview on 6/09/2023 at 10:50 AM, Clinical Manager 1 indicated the agency's performance improvement projects/activities included urinary tract infections (UTIs), wound infections, and he wasn't sure what else; and those areas were chosen based on a large number of patients with urinary catheters, and he also thought skin infections was another performance improvement project. The RN Educator indicated acute care hospitalization was higher than they wanted them to be. During an interview on 7/11/2023 at 1:22 PM, the Registered Nurse (RN) Educator indicated she was in charge of the QAPI program, in collaboration with the Clinical Managers, the Administrator, and the National Quality Team (not agency employees). During an interview on 7/11/2023 at 2:33 PM, the RN Educator indicated the hospitalization project was picked because at one point the agency had a lot of congestive heart failure patients, so that was a issue; and when she started working for the agency, that was what was being done. The Administrator indicated it was the same for him, as he was a newer employee; and they met as a team to decide what they focused on, and the RN Educator would propose that to her supervisor (Person 2, not an agency employee).

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure ongoing interdisciplinary assessments occurred, for 5 of 20 clinical record reviewed. (Patient #2, 4, 5, 9, 10). The finding include: 1.Clinical record review for patient #13 was completed on 6/28/2023 (start of care 5/17/2023) for certification period 5/17/2023- 7/15/2023. Record review evidenced a plan of care, which indicated diagnosis of oxygen dependency and acute on chronic respiratory failure with hypoxia. Record review of nurse assessment, indicated patient demonstrated shortness of breath, cough, and diminished lung sounds throughout lung fields. Patient was hospitalized with respiratory failure on 5/30/2023-6/02/2023. Record review failed to evidence clinical manager or physician were notified of abnormal assessment. Record review failed to evidence interdisciplinary assessment of patient. During an interview on 6/28/2023 at 2:34 PM, Clinical Manager 1 indicated the nurse failed to call and inform interdisciplinary team of the abnormal lung assessment. 2. Clinical record review for patient #20 was completed on 6/26/2023 (start of care 5/25/2023) for certification period /25/2023-7/23/2023. Record review evidenced a plan of care, which indicated diagnosis of chronic kidney disease and dialysis. Record review of admission assessment indicated patient demonstrated shortness of breath. Record review failed to evidence clinical manager or physician were notified of abnormal assessment. Record review failed to evidence interdisciplinary assessment of patient. During an interview on 6/26/2023 at 1:40 PM, RN Educator indicated a further assessment of respiratory status was needed for the patient. 1. Review of an agency policy with review date 9/01/2022, titled, "ASSESSMENT/REASSESSMENT", stated, "... Assessments and reassessments are done ... Depending on the patient's diagnosis, symptoms, or deficits, the patient may require intervention by another discipline ... Interdisciplinary communication occurs periodically in order to integrate assessment data from and among other disciplines ...." Review of an agency policy with review date 7/08/2022, titled, "HOME CARE COORDINATION", stated, "... Documents coordination activities on appropriate notes in the hospital or home health electronic medical record ...." 2. Clinical record review for Patient #2 was completed on 6/27/2023, start of care date 5/22/2023. Record review evidenced a plan of care (certification period 5/22/2023 - 7/20/2023), which evidenced ordered services included Skilled Nursing (SN), Physical Therapy (PT), and Occupational Therapy (OT). Record review evidenced an initial comprehensive assessment dated 5/22/2023. The document evidenced the patient's primary diagnosis was intestinal obstruction, not specified if partial or complete, had abdominal pain almost constantly, and current pain level was "7" (0-10 pain scale, with 0= no pain, and 10= worst pain imaginable). Record review evidenced a Physical Therapy (PT) evaluation visit note dated 5/24/2023. The document evidenced the patient's pain was worse, reported a pain level of "8-9" in the lower back and abdomen, had nausea, and was unable to perform transfers nor walk due to the severe pain. The document evidenced the PT notified the physician regarding the therapy plan of care, but failed to evidence interdisciplinary assessment occurred with the SN for the severe pain, nausea, or inability to transfer/ambulate due to pain. During an interview on 6/27/2023 at 2:33 PM, Clinical Manager 1 confirmed that on 5/25/2023 at 7:00 PM or so, the patient was seen in the Emergency Department and subsequently hospitalized for acute abdominal pain and nausea/vomiting. 3. Clinical record review for Patient #4 was completed on 6/27/2023 (start of care date 3/27/2023, certification period 3/27/2023 - 5/25/2023). Record review evidenced a resumption of care visit was completed by a PT on 5/08/2023, after the patient's hospitalization for hip revision surgery, the patient had a dressing which covered the left hip, and family changed the dressing (not further specified). The document failed to evidence interdisciplinary assessment occurred with the Clinical Manager for wound care or addition of nursing services if indicated. Record review evidenced a resumption of care visit was completed by a PT on 5/15/2023, after the patient's hospitalization. The document evidenced the patient had a newly placed Prevena (brand name) negative pressure wound treatment (NPWT) device (a portable, disposable system, which uses negative pressure [like a vacuum] to help heal and protect the incision, to be managed only by qualified clinical professionals) over the left hip incision. Record review failed to evidence any interdisciplinary assessment occurred with the Clinical Manager for the use of the Prevena NPWT device. During an interview on 6/27/2023 at 3:47 PM, the Registered Nurse (RN) Educator indicated she assumed the hospital would have trained the patient/family about the management/treatment of the Prevena NPWT device, and the agency didn't typically manage those. 4. Clinical record review for Patient #5 was completed on 6/29/2023 (start of care date 4/06/2023). Record review evidenced a plan of care for certification period 4/06/2023 - 6/04/2023, which evidenced SN, PT, and OT was ordered. Record review evidenced an initial and comprehensive assessment was completed by a PT on 4/06/2023. The document evidenced the patient's primary diagnosis of sepsis (occurs when chemicals are released in the bloodstream to fight an infection, which triggers inflammation throughout the body, and could cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even resulting in death) was poorly controlled and needed frequent adjustments in treatment and dose monitoring; and other diagnoses included hydronephrosis (condition characterized by excess fluid in a kidney due to a backup of urine, caused by a blockage in the tube that connects the kidney to the bladder; possible causes include infection; and symptoms include difficulty urinating and pain in the side, abdomen, or groin); PT and OT were the only reasonably necessary disciplines recommended, the patient was likely to remain in fragile health and have ongoing high risk(s) of serious complications and death, and the patient and caregiver had knowledge deficits related to pathophysiology (how a disease, injury, or other condition affects a patient, including both the physical and functional changes) of the patient's diagnoses and medications; had shortness of breath, pain (unable to answer what location), poor hydration and appetite, had an ileostomy (an artificial opening in the abdomen to drain feces), was a high nutritional risk, prior to hospitalization/home care services, the patient received intravenous (IV) saline (sterile salt water) infusions twice weekly for the past 2 years, after the ileostomy was created; and family reported the patient sustained an injury to the left elbow (not further detailed) while hospitalized, and was keeping it covered with a bandage. Record review failed to interdisciplinary assessment occurred with the Clinical Manager or SN for wound care, the complex medical concerns, wound, ileostomy management, or follow up on resumption of IV saline infusions. Record review evidenced an OT visit evaluation dated 4/07/2023. The document evidenced the OT notified the physician for the patient's report of difficulty breathing, anxiousness, and difficulty sleeping; and documented the patient stated "I can't sleep, I feel like I can't breathe." The document failed to evidence interdisciplinary assessment occurred with the Clinical Manager. During an interview on 6/29/2023 at 12:15 PM, the RN Educator indicated she couldn't say why the nurse didn't go out on the same day (4/07/2023), and didn't know if there was nursing staff available. 6. A home visit was observed with Patient #9 on 6/20/2023 at 11:30 AM. Clinical Manager 1 and Licensed Practical Nurse (LPN) 1 were present. Prior to entering the home, Clinical Manager 1 indicated there was a suspected bedbug infestation in the home, he was unaware until today, and this was a significant change from what he knew about the patient. Once in the home, the patient presented alert and oriented, lying on his bed in the living room, and the bed linens were visibly soiled; the bed and floor had innumerable live and dead bedbugs on it, the home had a very foul odor, and there were urinals with urine in them sitting on furniture; the patient's skin and hair was visibly dirty, was clothed only in a soiled t-shirt, a soiled brief, and soiled socks. LPN 1 indicated she was supposed to fill the medication pill planner every week, confirmed there were no current medications in the home to fill the medication planner, and this was not a new problem. Clinical record review for Patient #9 was completed on 6/20/2023, 6/21/2023, 6/27/2023, and 6/29/2023 (start of care 3/30/2023). Record review evidenced a nursing visit note dated 6/02/2023, which evidenced the nurse contacted APS and a report was filed. Record review evidenced a nursing visit note dated 6/05/2023, which evidenced a homeless person lived with client, was asking for money, and not tending to the patient's needs. The document failed to evidence interdisciplinary assessment occurred with the Clinical Manager. Record review evidenced a PT visit note dated 6/09/2023, which failed to evidence interdisciplinary assessment occurred with the Clinical Manager regarding the patient's living conditions. Record review evidenced a OT evaluation visit note dated 6/11/2023, which failed to evidence interdisciplinary assessment occurred with the Clinical Manager regarding the results of the evaluation visit, or the patient's living conditions. During an interview on 6/20/2023 at 2:57 PM, Clinical Manager 2 indicated the patient was admitted for homecare services and subsequently hospitalized within a day or so, and she knew she spoke to the hospital's case manager about the dire living conditions, and recommended a nursing home. 7. Clinical record review for Patient #10 was completed on 6/27/2023 (start of care 4/22/2023). Record review evidenced an initial plan of care (certification period 4/22/2023 - 6/20/2023), which evidenced the patient's primary diagnosis was chronic obstructive pulmonary disease (COPD) with acute (severe and sudden onset) exacerbation (increase in symptom intensity), and additional diagnoses included asthma, acute respiratory failure with hypoxia (absence of enough oxygen in the tissues to sustain bodily functions), and hyperglycemia (high blood sugar levels); the patient required continuous supplemental oxygen (O2), PT performed the initial evaluation/comprehensive assessment, and nursing was ordered to begin weekly after the start of care visit, with 3 "as needed" visits for changes in condition. Record review evidenced the initial comprehensive assessment was completed 4/22/2023. The document evidenced the patient's COPD was poorly controlled, and the patient needed frequent adjustments in treatments and dose monitoring; the primary home care focus was shortness of breath, and the PT observed the patient not wearing O2 upon arrival because she couldn't switch the O2 cylinders, assessed the patient's oxygen (O2) saturation was 80% (88% - 92% O2 level is considered safe for someone with moderate to severe COPD, levels below 88% become dangerous, and any level 80% or lower is dangerous for the vital organs and needs urgent treatment), and after the PT switched the cylinders and administered O2, the patient's O2 level increased to 96%. The document stated, "... Care Coordination ... Indicate if you communicated with other disciplines involved in this case ... NO ...." During an interview on 6/27/2023 at 4:12 PM, the Clinical Manager 1 indicated Nursing should have performed the initial assessment/comprehensive assessment, so the O2 issue could have been dealt with right away, but during that time period, they were still under the COVID-19 waiver, they probably didn't have the staff for nursing, and they took advantage of the waiver to allow therapy to open all cases; and the RN Educator indicated it was better to start cases sooner than later. 410 IAC 17-12-2(g)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the clinician failed to accurately prepare clinical notes in 5 of 20 clinical records reviewed. (Patient #1, 3, 10, 12, 15). The findings include: Review of an agency document titled, "Care Management and Plan of Care" last reviewed on 12/09/2021, stated " Assesses the patient using the appropriate comprehensive assessment form and discusses the plan for care with the patient … For therapy-only cases, the therapist requests a physician order for 1 or more nursing visit (s) if the needed for medication management/instruction if needed or has care needs which are not within the therapist's scope of practice." 1. Clinical record review for patient #12 was completed on 6/28/2023 (start of care 6/03/23) for certification period 6/03/2023-8/01/2023. Record review evidenced an admission plan, which indicated a set of vital parameters for physician notification for respirations of 728 per minute. Record review failed to ensure clinician accurately prepared clinician note. During an interview on 6/26/2023 at 11:54 AM, the RN Educator indicated the clinician documented this in error. 2.Clinical record review for patient #13 was completed on 6/28/2023 (start of care 5/17/2023), for certification period 5/17/2023-7/15/2023. Record review evidenced a plan of care, which indicated a pulse oximetry to be taken with each visit and blood sugar monitoring were ordered three times a day. Record review evidenced an initial comprehensive assessment, which indicated an oxygen saturation was not taken upon admission assessment. Record review of a nurse visit note, which indicated patient checked blood sugar twice a day. Record review failed to endure nurse accurately prepared nurse note. During an interview on 6/28/2023 at 2:42 PM, the Administrator indicated the oxygen saturation level is part of a respiratory assessment and indicated it was not documented. At 2:46 PM, the Administrator indicated the blood sugar frequency was documented incorrectly by the nurse. 3. Clinical record review for patient #14 was completed on 6/27/2023 (start of care 6/02/2023), for certification period 6/02/2023-7/31/2023. Record review evidenced a plan of care, which indicated patient checked blood sugars three times a day. Record review of a nurse visit note, which indicated patient checked blood sugars twice a day. Record review failed to endure nurse accurately prepared nurse note. During an interview on 6/28/2023 at 2:25 PM, the Administrator indicated the blood sugar documentation of twice a day was documented in error by the nurse. 4. Clinical record review for patient #15 was completed on 6/26/2023 (start of care 6/04/2023) for certification period 6/04/2023-8/02/2023. Record review evidenced a plan of care, which indicated a set of vital parameters for physician notification for respirations of 728 per minute. Record review failed to ensure clinician accurately prepared clinician note. During an interview on 6/26/2023 at 11:54 AM, the Rn Educator indicated the clinician documented this in error. 5. Clinical record review for patient #19 was completed on 6/26/2023 (start of care 6/07/2023) for certification period 6/07/2023-8/05/2023. Record review evidenced a plan of care, which indicated diagnosis of end stage renal disease and home hemodialysis (removing waste and fluid from blood). Record review failed to evidenced documentation of type and location of the dialysis access. Record review failed to ensure clinician accurately prepared clinician note. During an interview on 6/26/2023 at 11:04 AM, the RN Educator indicated the assessment of the dialysis access and location should be on the assessment notes. 6. Clinical record review for patient #20 was completed on 6/26/2023 (start of care 5/25/2023) for certification period 5/25/2023-7/23/2023. Record review evidenced a plan of care, which indicated diagnosis of end stage renal disease and hemodialysis. Record review indicated patient had no falls in the last 3 months and no assessment of left arm was noted. Record review evidenced a cast was on left arm was removed on 6/06/2023. Record review failed to evidence documentation of type and location of the dialysis access. Record review failed to indicate a fall within the last 3 months prior to admission. Record review failed to evidence of circulatory and sensation assessment of left arm while cast was in place. Record review failed to evidence circulatory and sensation assessment of left arm after cast was removed. Record review failed to ensure clinician accurately prepared clinician note. During an interview on 6/26/2023 at 2:07 PM, the Administrator indicated the therapists do not assess the dialysis site for bruit and thrill (swish sound and vibration). The Administrator indicated documentation of the location of the access should be in the notes. During an interview on 6/26/2023 at 1:42 PM, the RN Educator indicated the documentation regarding falls was incorrect. At 1:44 PM, indicated on every visit the circulatory, movement and sensation assessment of the arm with a cast needed to be documented. * Clinical record review for Patient #1 was completed on 6/27/2023 (start of care date 2/11/2023). Record review evidenced a plan of care for certification period 4/12/2023 - 6/10/2023, which evidenced the patient was to weigh daily. During an interview on 6/27/2023 at 1:58 PM, Clinical Manager 1 indicated the patient couldn't stand, so daily weight shouldn't be on the plan of care. * Clinical record review for Patient #3 was completed on 6/27/2023 (start of care date 5/27/2023). Record review evidenced the plan of care, which evidenced orders for Physical Therapy (PT) to instruct patient to call the doctor for 2 or more pounds weight gain overnight, or more than 5 pounds weight gain in 1 week; but also orders for PT to report (to physician) for 3 or more pounds weight gain in 24 hours. During an interview on 6/20/2023 at 3:50 PM, the Clinical Manager indicated the weight parameters was an error, and the PT must have entered an extra set. * Clinical record review for Patient #10 was completed on 6/27/2023 (start of care 4/22/2023). Record review evidenced the initial comprehensive assessment was completed 4/22/2023. The document evidenced the patient's baseline weight was 158 pounds. Record review evidenced a PT reassessment visit note dated 5/18/2023, and the patient's weight was 117 pounds. During an interview on 6/27/2023 at 4:12 PM, Clinical Manager 1 indicated the weight was an error on the 5/18/2023 visit note. 410 IAC 17-14-1(a)(1)(E) 410 IAC 17-14-1(c)(5)

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, record review, and interview, the home health agency failed to ensure: administrative and supervisory functions were not delegated to another organization; and the agency's organizational chart failed to identify its organizational structure, to include all lines of authority (Please see tag G0940); failed to be responsible for the agency's day-to-day operations (Please see tag G0948); the Clinical Manager failed to provide oversite for making patient and personnel assignments (Please see tag G0960); and the Clinical Manager provided oversite for coordination of all patient referrals (Please see tag G0964). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.105: Organization and Administration of Services. With regard to G0940, the findings include: 1. Review of the agency's "Patient Information Handbook" dated 2016, evidenced patient privacy violation complaints should be filed with Entity 1's (corporate owner) Privacy Officer (Person 9, not an agency employee); and other complaints should be filed with the agency, but appeals to findings must be submitted to Person 9. 2. Review of an agency policy dated 3/05/2023, titled "Mishawaka Home Care Organizational Chart", evidenced the Registered Nurse (RN) Educator reported directly to Person 4 (Regional Director of Clinical Education, not an agency employee), the Human Resource (HR) Manager reported directly to Person 5 (Regional Manager of Colleague Relations, not an agency employee), the Home Care Coordinator and Strategic Account Manager reported directly to Person 6 (Regional Sales Manager, not an agency employee), and the agency schedulers reported to Person 7 (National Director of Scheduling, not an agency employee); and none of those employees reported directly to the agency's Administrator. 3. Review of the agency's organizational chart also evidenced the top level was the Board of Directors; the second level was the Regional Director of Home Health Operations, and a dotted line horizontally to the right, and equal to the Regional Director of Home Health Operations was Person 1 (VP Operational Excellence/Regional Executive Director, not an agency employee); the third level evidenced Physical Therapists, Physical Therapist Assistants, Speech Language Pathologists, Occupational Therapists, Certified Occupational Assistants, RNs, Licensed Practical Nurses, Home Health Aides, (2) Clinical Managers, Office Manager, Administrative Assistant, and Document Specialist all reported equally to the Regional Director of Home Health Operations. 4. Review of an agency job description revised March 2008, titled, "Performance Evaluation & Job Description Licensed Practical Nurse (LPN)", evidenced the LPN reported directly to the "Team Leader or Designated Nurse". The agency's Organizational Chart evidenced the LPN reported directly to the Regional Director of Home Health Operations (Administrator). 5. Review of an agency job description revised 3/19/2021, titled, "Job Description" evidenced the job title was "Primary Care Nurse", was a RN job description, and the RN reported directly to the Clinical Manager. The agency's Organizational Chart evidenced the RN reported directly to the Regional Director of Home Health Operations. 6. Review of an agency job description dated 3/15/2021, titled, "Quality Management Educator", evidenced the RN Educator signed the document on 5/31/2022, and reported directly to Person 2 (Director of Quality [not an agency employee] for Entity 1 [corporate/owner]). 7. Review of an agency job description dated January 2017, titled, "Job Description Clinical Manager", evidenced the RN Educator signed the document 6/04/2022, and reported to the Clinical Director of Operations or Agency Administrator. The agency's Organizational Chart failed to evidence a job title of neither Clinical Director of Operations nor Agency Administrator . 8. Review of an agency job description revised March 2008, titled, "Performance Evaluation & Job Description Licensed Practical Nurse (LPN)", evidenced the LPN reported directly to the "Team Leader or Designated Nurse". The agency's Organizational Chart evidenced the LPN reported directly to the Regional Director of Home Health Operations (Administrator). 9. Review of an agency document dated 6/08/2023, titled "Saint Joseph VNA Home Care Colleagues List", evidenced the Registered Nurse (RN) Educator, Human Resource (HR) Manager, Home Care Coordinator, Strategic Account Manager, and schedulers were employed by the agency; and failed to evidence Person 1, Person 2, Person 4, Person 5, Person 6, Person 7, Person 8 (Manager Scheduling, not an agency employee) were employed by the agency. 10. During an interview on 6/26/2023 at 11:26 AM, the Administrator indicated Person 9 was their integrity and compliance officer, she wasn't an agency employee, and she was corporate level at Entity 1. 11. During an interview on 6/08/2023 at 1:32 PM, the Administrator indicated he was appointed as the agency's Administrator in October 2022, Clinical Manager 1 was appointed in July 2021, and also appointed as the Alternate Administrator in June 2022; the RN Educator was appointed as the Alternate Clinical Manager in June 2022, and Clinical Manager 2 was appointed 1/06/2023. 12. During an interview on 6/08/2023 at 2:55 PM, the HR Manager submitted a document titled "Saint Joseph VNA Home Care Colleagues List", and indicated it was a complete list of every agency employee. 13. During an interview on 6/19/2023 at 10:10 AM, RN 1 indicated the RN Educator was the Administrator, and didn't know who the Alternate Clinical Manager was. 14. During an interview on 6/23/2023 at 9:00 AM, LPN 2 indicated the Administrator was also the Clinical Manager, and Clinical Manager 1 was "second". 15. During an interview on 6/26/2023 at 1:08 PM, the Administrator indicated they were "under" Entity 1 (corporate owner). 16. During an interview on 6/26/2023 at 3:10 PM, Person 1 indicated they were all the same corporate entity, each agency had a "Doing Business As" (DBA), but were all owned by Entity 1. 17. During an interview on 6/28/2023 at 4:11 PM, the Administrator indicated they confirmed with Person 9 that a contract/written agreement to share administrative/supervision responsibilities between the agency and the corporation wasn't needed, since it was one legal entity. 410 IAC 17-12-1(a)(1) 410 IAC 17-12-1(a)(2)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the Administrator failed to be responsible for the agency's day-to-day operations. Findings include: The Administrator failed to ensure the Physical Therapist (PT) completed a full head to toe comprehensive assessment/reassessment (Please see tag G0528); the patient's clinical record contained a complete list of the patient's current medications, and/or the physician was promptly notified of any significant potential drug interactions identified (Please see tag G0536); and failed to ensure a comprehensive reassessment was conducted when the patient experienced a significant change in condition (Please see tag G0544). The Administrator failed to ensure the agency only accepted patients for services if the needs of the patient could be met for (Please see tag G0570); vital parameters were individualized to the patients' specific needs (Please see tag G0572); failed to ensure all patients' plans of care including all required elements (Please see tag G0574); failed to ensure the clinician promptly notified the physician/practitioner for a change in the patient's condition or needs (Please see tag G0590); failed to assure communication with all physicians involved in the plan of care (Please see tag G0602); failed to participate in the coordination of care with outside providers (Please see tag G0606); failed to ensure the agency prepared and/or provided all patients with an up-to-date written medication schedule (Please see tag G0616); and failed to ensure all patients were provided with written information for all treatments administered by the agency (Please see tag G0618). The Administrator failed to ensure the agency’s Quality Assessment Performance Improvement (QAPI) program showed measurable improvement in falls with major injury; and failed to include complaints in the agency's QAPI program, to assess processes of care, agency services, and operations (Please see tag G0642); failed to ensure the agency's governing body approved the frequency and detail of the data collection (Please see tag G0644); failed to ensure its performance improvement activities focused on agency-specific high risk, high volume, and/or problem-prone areas (Please see tag G0648); failed to ensure its program activities led to immediate correction of any identified problem that directly and/or potentially threatened the health and safety of patients (Please see tag G0652); failed to take action aimed at performance improvement for the problem prone area of the difficulty staffing nursing services (Please see tag G0656); and failed to ensure performance improvement project(s) documented the reason the agency-specific performance improvement projects were chosen (Please see tag G0658). The Administrator failed to ensure administrative and supervisory functions were not delegated to another organization; and the agency's organizational chart failed to identify its organizational structure, to include all lines of authority (Please see tag G0940); failed to ensure the Clinical Manager provided oversite for making patient and personnel assignments (Please see tag G0960); or the Clinical Manager provided oversite for coordination of all patient referrals (Please see tag G0964). During an interview on 6/08/2023 at 1:32 PM, the Administrator indicated he was appointed as the agency's Administrator in October 2022. During an interview on 6/26/2023 at 11:26 AM, the Administrator indicated the patients wouldn’t know who the Administrator was in the home folder, they would have to call the office and someone would tell them; and the Clinical Manager was responsible for complaints, and if it wasn't resolved, it would escalate to him. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to provide oversite for making patient and personnel assignments. The findings include: Review of an agency document dated 6/08/2023, titled "Saint Joseph VNA Home Care Colleagues List", evidenced the Schedulers, Strategic Account Manager, and Home Care Coordinator were employed by the agency; and failed to evidence neither Person 6 (Regional Sales Manager), Person 7 (National Director of Scheduling), nor Person 8 (Manager Scheduling) were employed by the agency. Review of an agency policy dated 3/05/2023, titled "Mishawaka Home Care Organizational Chart", evidenced the agency Schedulers and Manager Scheduling reported to Person 7, none of which reported to the agency's Administrator or Clinical Manager; and the Strategic Account Manager and Home Care Coordinator reported to Person 6, also none of which reported to the agency's Administrator or Clinical Manager. Review of an agency job description signed by Clinical Manager 1 on 7/07/2021, titled "Clinical Manager", failed to evidence job duties included oversight of patient/personnel schedules. During an interview on 6/26/2023 at 2:47 PM, the Administrator indicated the Strategic Account Manager and Home Care Coordinator handled the referral process. 410 IAC 17-14-1(a)(1)(K)

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to provide oversite for coordination of all patient referrals. The findings include: Review of an agency document dated 6/08/2023, titled "Saint Joseph VNA Home Care Colleagues List", evidenced the Schedulers, Strategic Account Manager, and Home Care Coordinator were employed by the agency; and failed to evidence neither Person 6 (Regional Sales Manager), Person 7 (National Director of Scheduling), nor Person 8 (Manager Scheduling) were employed by the agency. Review of an agency policy dated 3/05/2023, titled "Mishawaka Home Care Organizational Chart", evidenced the agency Schedulers and Manager Scheduling reported to Person 7, none of which reported to the agency's Administrator or Clinical Manager; and the Strategic Account Manager and Home Care Coordinator reported to Person 6, also none of which reported to the agency's Administrator or Clinical Manager. During an interview on 6/26/2023 at 2:47 PM, the Administrator indicated "Central Intake" funnels down patient referrals, the Strategic Account Manager and Home Care Coordinator handled the referral process, but complex cases like patients with IVs (intravenous access lines), "vacs" (negative pressure wound therapy, a complex wound treatment), tracheostomies (a surgical opening in the airway to allow breathing), and stuff like that would go to Clinical Managers 1 or 2 to approve.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all encoded OASIS (Outcome and Assessment Information Set) data accurately reflected the patient's health status during the time the assessment was completed for 1 of 3 clinical records reviewed (#3). Findings include: Review of a policy dated 4/2020, titled "Initial Assessment and Admission for Services" stated "... The clinician conducting the initial OASIS assessment completes their assessment during a visit, although the assessment opinions of other clinicians can be included ... as permitted by CMS [Centers for Medicare and Medicaid Services] guidelines for OASIS completion...." Review of a web-based reference site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-D-Guidance-Manual-final.pdf, titled "OASIS-D Guidance Manual ... Effective 1/1/2019 ... Centers for Medicare & Medicaid Services" stated "... For items requiring patient assessment, the collaborating healthcare providers must have had direct contact with the patient ... [comprehensive re-assessment] and other follow-up ... the assessments must be completed on, or within 48 hours ... Follow-Up (FU): This information is collected at Recertification and Other Follow-up ... M0090 ... Date assessment completed should reflect the last date the assessing clinician gathered or received any input used to complete the comprehensive assessment, including the OASIS items ... (M1242) [requires patient assessment] ... Frequency of Pain Interfering with patient's activity or movement ... (M1340) ... [requires patient assessment] ... Does this patient have a Surgical Wound? ... ITEM INTENT ... Identifies the presence of a wound resulting from a surgical procedure ... (M1342) ... [requires patient assessment] ... Status of Most Problematic Surgical Wound that is Observable ... (M1400) ... [requires patient assessment] ... When is the patient dyspneic or noticeably Short of Breath? ... Response 0 would apply if the patient has not been short of breath during the day of assessment...." Review of a web-based reference site: http://www.fazzi.com/tl_files/pages/oasis/Appendix%20A-G.pdf, titled "APPENDIX A - OASIS AND THE COMPREHENSIVE ASSESSMENT" stated "... Follow-up assessments must be completed every 60 days that a patient is under care ... For Medicare and Medicaid patients, when a follow-up assessment is due, it must be completed no earlier than four calendar days before, and no later than the day marking the end of the 60-day period (i.e., day 56 through day 60 of the period) ...." Record review for patient #3 was completed on 7/15/2021, start of care date 3/9/2021, for re-certification period 7/7/2021 - 9/4/2021, and failed to evidence direct patient contact/assessment by a clinician occurred after 7/2/2021 and prior to 7/7/2021 at 8:56 AM, to substantiate the changes made to OASIS items which included M1242 (pain), M1340 (presence of a surgical wound), M1342 (status of the surgical wound), and M1400 (presence of shortness of breath), and failed to evidence the amended data entered on 7/7/2021, accurately reflected the patient's health status during the time the assessment was completed on 7/2/2021. Review of a document titled "PT [physical therapy] Recert with Skill" stated "... (M0090) Date assessment completed: 7/2/2021 ... Pain ... Was [patient] able to completely discuss his/her pain assessment? ... Yes, [patient] was able to completely discuss his/her pain ... [patient] reports no pain at any time during the 24 hour day ... (M1242) ... 0- Patient has no pain ... (M1340) Does this patient have a surgical wound? ... 0- No ... Indicate integumentary [skin] assessment findings: ... No problems identified ... Was Respiratory system addressed? ... Yes ... (M1400) When is the patient ... short of breath? ... 0- Patient is not short of breath ...." The document also evidenced it was last modified on 7/7/2021 at 8:56 AM, by RN [registered nurse] J, and stated "... ADDENDUM ... Question: M1242 [pain] ... Pre-edit answer: 0- No ... Post-edit answer: 1 [yes] ... Question: M1400 ... Pre-edit answer: 0 [not short of breath] ... Post-edit answer 1- when walking more than ... Question: M1340 ... Pre-edit answer: 0- No [patient did not have a surgical wound] ... Post-edit answer: 1- Yes , patient has at least [one surgical wound] ... Question M1342 ... status of ... surgical wound ... Pre-edit answer: [not applicable] ... Post-edit answer: 3- Not healing...." Review of a document dated 7/7/2021, titled "PT Subsequent Visit" evidenced the visit was completed from 5:53 PM - 6:37 PM, and stated "... Integumentary assessment findings ... no problems identified ... patient concerned about open area on anterior [front] side of stump ... speculation [of] shear [injury created by friction] between silic9ne [sic] and skin upon prosthesis [artificial limb] wearing ... reports no pain ...." The wound was identified after the addendum was made to the OASIS item set, was identified as an injury created by friction, not a surgical wound, and failed to evidence it was not healing. During an interview on 7/15/2021 9:40 AM, the administrator indicated addendums to the assessments (including OASIS items) were made with approval of the assessing clinician, clinicians had 5 days to complete recertification assessments,she would argue there might be at least some shortness of breath since the patient used oxygen at night, and agreed an assessment of the wound was not completed until after addendums were already made.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all clinicians completed the comprehensive re-assessment during the last 5 days of every 60 day certification episode for 1 of 3 clinical records reviewed (#3). Findings include: Review of a policy dated 4/2020 titled "Care Management and the Plan of Care" stated "... Recertification/Subsequent Episode ... Ensure the Re-cert OASIS assessment is completed during a visit on the 56th to the 60th day of the current episode ....", The document evidenced the recertification visit note, orders, and a summary of clinical findings for the past plan of care episode must be submitted within 24-48 hours of the actual visit made, and the documentation must be completed and submitted to the agency by the end of day 60. Review of a web-based reference site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-D-Guidance-Manual-final.pdf, titled "OASIS-D Guidance Manual ... Effective 1/1/2019 ... Centers for Medicare & Medicaid Services" stated "... For items requiring patient assessment, the collaborating healthcare providers must have had direct contact with the patient ... [comprehensive re-assessment] and other follow-up ... the assessments must be completed on, or within 48 hours ... Follow-Up (FU): This information is collected at Recertification and Other Follow-up ... M0090 ... Date assessment completed should reflect the last date the assessing clinician gathered or received any input used to complete the comprehensive assessment, including the OASIS items ...." Review of a web-based reference site: http://www.fazzi.com/tl_files/pages/oasis/Appendix%20A-G.pdf, titled "APPENDIX A - OASIS AND THE COMPREHENSIVE ASSESSMENT" stated "... Follow-up assessments must be completed every 60 days that a patient is under care ... For Medicare and Medicaid patients, when a follow-up assessment is due, it must be completed no earlier than four calendar days before, and no later than the day marking the end of the 60-day period (i.e., day 56 through day 60 of the period) ...." Record review for patient #3 was completed on 7/15/2021, start of care date 3/9/2021, re-certification period 7/7/2021 - 9/4/2021, and failed to evidence the comprehensive re-assessment was completed during the last 5 days of the certification episode (7/2/2021 - 7/6/2021). Review of a document titled "PT [physical therapy] Recert with Skill" stated "... (M0090) Date assessment completed: 7/2/2021. The document evidenced it was last modified on 7/7/2021 at 8:56 AM, by RN [registered nurse] J. The completion date was 7/7/2021, not 7/2/2021, which was the last date the assessing clinician received any input used to complete the comprehensive assessment, including the OASIS items. During an interview on 7/15/2021 9:40 AM, the administrator indicated addendums to the comprehensive re-assessments (including OASIS items) were made with approval of the assessing clinician, and clinicians had 5 days to complete recertification assessments. 17-14-1(a)(1)(B)

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 ensure all revised plans of care included a summary of the patients' progress toward measurable outcomes and goals for 2 of 2 clinical records reviewed with services that were provided for greater than 60 days (#1, 3). Findings include: 1. Review of a policy dated 4/2020 titled "Care Management and the Plan of Care" stated "... During visits and other patient contacts, the clinician regularly reevaluates the [patient's] medical condition ... the achievement or lack of achievement of goals and outcomes ... A summary of care (clinical findings) provided by all disciplines is included with each 60-day plan of care for physician review ... Any revisions to the plan of care reflect current information ... and the patient progress toward goals and measurable outcome...." 2. Record review for patient #1 was completed on 7/15/2021, start of care date 5/5/2019, for re-certification period 6/23/2021 - 8/21/2021, which evidenced a document titled "Home Health Certification and Plan of Care" and failed to evidence a summary of the patients' progress toward measurable outcomes and goals for the previous 60 day certification period. 3. Record review for patient #3 was completed on 7/15/2021, start of care date 3/9/2021, for re-certification period 7/7/2021 - 9/4/2021, which evidenced a document titled "Home Health Certification and Plan of Care" and failed to evidence a summary of the patients' progress toward measurable outcomes and goals for the previous 60 day certification period. 4. During an interview on 7/15/2021 9:40 AM, when queried if a summary of the patients' progress toward measurable outcomes and goals for the previous certification period should be included on recertification plans of care, the administrator indicated she wasn't sure if it was required.

This was a fully extended federal and state survey with 2 complaints. Complaints: IN00284807 - substantiated with findings IN00216770 - substantiated with findings Survey dates: February 9, 10, 11, 22, 23, 24, 25, 26; and March 1, 2 (2021). Facility number: IN005248 Provider number: 157005 Current census: 229 This deficiency report reflects State Findings cited in accordance with 410 IAC Article 17. Refer to State Form for additional State Findings. Saint Joseph VNA Home Health Care is precluded from providing its own home health training and competency evaluation for a period of two years beginning 2/2/2021 - 2/2/2023 due to being found out of compliance with the Conditions of Participation 42 CFR 484.55 Comprehensive Assessment of Patients, Saint Joseph VNA Home Health Care is precluded from providing its own home health training and competency evaluation for a period of two years beginning 2/2/2021 - 2/2/2023 due to being found out of compliance with the Conditions of Participation 42 CFR 484.55 Comprehensive Assessment of Patients, 484.60 Care planning, coordination, and quality of care and 484.105 Organization and administration of services. and 484.105 Organization and administration of services. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all comprehensive assessments accurately reflected the patients' current health status (G528); and failed to ensure the comprehensive re-assessments were completed as often as the patients' condition warranted (G544). This practice had the potential to affect all agency patients. The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients. 17-14-1(a)(1)(B)

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the physical therapist (PT) performed a complete comprehensive assessment that provided the agency with a total picture of the patient's current health status for 3 of 3 records reviewed with physical therapy as the only skilled service. (#7, 13, 14) The findings include: 1. Review of an agency policy, with an approval/review date of 4/2020, titled "Initial Assessment and Admission for Services" stated "... For-therapy-only [sic] cases, the therapist is the primary case manager ... staff begins the initial or comprehensive assessment ... discipline specific SOC/ROC [start of care/resumption of care] electronic assessments ... admitting staff provides appropriate care including ... observation and assessment, dressing changes, teaching and other services ... The clinician completes patient system assessment during the initial visit...." 2. Review of an agency policy with an approval/review date of 4/2020, titled "Care Management and the Plan of Care" stated "... During visits and other patient contacts, the clinician regularly reevaluates the client's medical condition ... assesses the patient using the appropriate comprehensive assessment form ... the therapist requests a physician order for 1 or more nursing visit(s) if the patient ... has care needs which are not within the therapist's scope of practice ...." 3. Review of an agency job description dated 05/08/2019, titled "Physical Therapist" stated "... Accurately assesses clients at admission and other required time points ... Reports changes in client condition as appropriate and in a timely manner ...." 4. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM , start of care date 1/22/2021, for certification period 1/22/2021 - 3/22/2021. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021. The patient's primary diagnosis was COVID-19, and other diagnoses included (but not limited to) pneumonia due to COVID-19, acute respiratory failure with hypoxia (deprivation of oxygen), acute on chronic systolic (congestive) heart failure, obstructive sleep apnea, type 2 diabetes with diabetic chronic kidney disease, non-ST elevation (NSTEMI) myocardial infarction (heart attack), constipation, long term (current) use of aspirin, and long term (current) use of anticoagulants. During the home visit, The patient presented sitting upright in his recliner with both legs elevated 90 degrees to his body, and feet rested on a firm, ridged pillow, which caused visible pitting into both posterior ankles. His abdomen was significantly distended. He was not wearing socks, and had no footwear visible in his immediate area. Both lower legs were extremely swollen, dark red, shiny, and had multiple small open areas. His left great toe presented with a black necrotic (dead body tissue) area approximately 1.0cm (centimeters) in diameter. His right 2nd toe was swollen, with a large blister present. He had a large SDTI (suspected deep tissue injury) on his right heel. The nurse assessed his buttocks/backside which revealed an open stage 2 pressure injury on his (left side) gluteal cleft (groove between the buttocks) just below his tailbone. The wound center was yellow, and the surrounding skin was dark purple. He did not have a pressure relieving cushion on his chair. He was wearing an incontinence brief, which was soiled. His skin on his bottom was moist and hyperpigmented (darker than normal color for patient). He indicated he had an old hospital bed that did not work (the head of the bed no longer elevated) so he was sleeping in his recliner since hospital discharge, as he had chest pain and difficulty breathing while in a supine (lying on back) position, his CPAP (Continuous Positive Airway Pressure machine that forces air into lungs, generally worn during sleep) was broken and he was waiting on a new one, his legs were like this since hospital discharge and getting worse, he had severe pain to the touch of the right heel and with any movement of both feet/lower legs, he had very limited ROM (range of motion) of both lower legs and feet due to swelling and severe pain, he had no footwear that fit him, and a nurse came out to see him for the first time last week (he also indicated he thought a nurse was coming from day one). He also indicated he had a heart attack while in the hospital, and he had ongoing chest pain and poor endurance, and he only changed his brief once daily, because it was "too hard to do more than that." Record review completed on 2/24/2021, and again on 3/2/2021, evidenced a document dated 1/22/2021, by PT [physical therapist] II titled "Visit Note Report" which stated "... Visit Type: ... PT OASIS [Outcome and Assessment Information Set] Admission" indicated the patient had no pain, a standard mattress was appropriate at that time, had minimal to no risk for skin breakdown. Additionally, the document stated "... Was integumentary [skin] assessed? No ... Not applicable ... Was cardiovascular system assessed? No ... Not applicable ... Respiratory assessment findings ... WNL [within normal limits] ... Was genitourinary system assessed? No ... Not applicable ... Gastrointestinal assessment ... Not assessed due to not applicable ... [patient statement] 'I have no pain' ... Patient does not need ... HHA [home health aide] ... or SN [skilled nurse] ... Was Endocrine [conditions such as, but not limited to diabetes, thyroid issues]/Hematopoietic [system of organs and tissues involved in the production of cellular blood components] assessed? No ... Not applicable ... Head and neck assessment findings ... Not assessed due to not applicable ... sleeps in recliner ...." The document failed to evidence a complete comprehensive assessment was completed to evidence the patient's current health status, the therapist failed to request a physician order to add skilled nursing for the patient's complex medical condition upon admission, the patient was subsequently seen in the emergency department on 2/17/2021 for swelling, draining, and intractable pain in both legs, and was prescribed antibiotics. He was seen in the emergency room again on 2/24/2021 and was admitted. He remained hospitalized upon survey exit. During an interview on 2/24/2021 at 11:27 AM, family stated they called 911 about "10 minutes ago [2/24/2021]" for chest pain, and stated "... [chest pain] It's been off and on since he got home from the hospital ...." She also indicated he got up this morning, he wasn't feeling good, he (patient) "... took like 6 nitros [nitroglycerin for chest pain] no relief." She also indicated he was coughing quite a bit after the nurse left yesterday (2/23/2021), and he didn't have a good night. When asked if the patient complained of pain since he came home from the hospital prior to the initiation of home health services (start of care), she stated "Yes. His feet, he never feels good. So much pain." During an interview on 2/24/2021 at 2:25 PM, the administrator/clinical manager indicated she thought PT's weren't taught how to listen to heart and lung sounds in therapy school, the PT clinical manager indicated she'd always been told not to listen to lung sounds, it wasn't in the PT scope of practice, PTs were supposed to check skin, respiratory status but not heart and lung sounds, and if there were cardiac issues, they referred nursing. When queried why a nurse wasn't referred upon start of care to complete a comprehensive assessment (patient's primary diagnosis was COVID-19, and additional pertinent respiratory and cardiac diagnoses), the administrator/clinical manager stated "I can't answer that. I don't know." 5. A home visit of patient #13 was observed on 2/25/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of displ intertroch fx L femur, subs for clos fx w routn heal (left hip fracture which required surgical intervention). The patient received physical and occupational therapy services, and skilled nursing and home health aide services were ordered on 2/22/2021. Review of a document dated 2/18/2021 by PT X titled "Visit Note Report" stated "... Visit Type: ... PT OASIS Admission" indicated there were no structural barriers in the patient's home, but stairs to enter the home, and stairs within the home were observed, the integumentary system was not assessed- "not applicable", the cardiovascular system was assessed, the respiratory system was not assessed- "not assessed due to not applicable", the genitourinary system was not assessed- "not applicable", the gastrointestinal system was not assessed- "not applicable", the head and neck was not assessed- "not assessed due to not applicable", and the immunologic assessment was not completed- "not assessed due to not applicable". The document failed to evidence a complete comprehensive assessment was completed to evidence the patient's current health status. 6. Record review for patient #14 was completed on 3/2/2021, start of care date 1/28/2021, primary diagnosis sepsis (a serious infection that causes your immune system to attack your body) due to E coli (bacteria). Review of a document dated and signed 1/28/2021, by PT Y titled "Visit Note Report" stated "... Visit Type: ... PT OASIS Admission" stated "... Was integumentary assessed? No ... not appropriate at time of evaluation ....", indicated pain in spine, and need for OT (occupational therapy), skilled nursing and home health aide services. The document failed to evidence a complete comprehensive assessment was completed to evidence the patient's current health status. Review of a document dated and signed 1/30/2021 by RN [registered nurse] U titled "Visit Note Report ... RN Add-On Evaluation" indicated no skin issues were identified, the patient had no pain, and no further nursing visits were necessary. Review of a document dated and signed 2/1/2021 by OT [occupational therapist] F titled "Visit Note Report ... OT Add-On Evaluation" stated "... Was integumentary [skin] assessed? No ....", and indicated the patient had left hip/groin pain. Review of a document dated and signed 2/2/2021, by PT Z titled "Visit Note Report ... PT Subsequent Visit" stated "... Pain on bed sore on bottom ....", and failed to evidence the patient's skin was assessed. Review of a document dated and signed 2/4/2021, by PT Z titled "Visit Note Report ... PT Subsequent Visit" stated "... Pain ... left buttocks pressure sore ... checked patient's buttocks while in bathroom and noted there looked like a stage II pressure sore [a partial thickness wound caused by pressure]; called MD [medical doctor] and gor [sic] order for SN to eval ...." 7. During an interview on 2/22/2021 at 1:24 PM, when asked why the PTs weren't doing complete physical assessments including (but not limited to) skin, cardiovascular, and respiratory assessments, PT clinical manager A indicated they probably weren't doing it if there was a nurse involved, if no nurse was involved then they would always do the assessments, and she always did a full assessment for the initial evaluation, but not necessarily every visit thereafter. During this interview, she also stated "PT don't do heart/lungs sounds." 8. During an interview on 3/2/2021 at 2:30 PM, the administrator/clinical manager agreed the comprehensive assessments were not complete, and indicated the agency immediately addressed the concern regarding incomplete comprehensive assessments as soon as it was brought to her attention on 2/24/2021.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure a comprehensive re-assessment (including the administration of the OASIS) was completed for all agency patients as frequently as the patients' condition warranted for 3 of 3 clinical records reviewed with a significant change in condition. (#1, 7, 14) The findings include: 1. Review of an agency policy, with an approval/review date of 4/2020, titled "Care Management and the Plan of Care" stated "... During visits and other patient contacts, the clinician regularly reevaluates the client's medical condition ... assesses the patient using the appropriate comprehensive assessment form ... The case manager/nurse/therapist: ... Reassesses the patient condition ... As appropriate ... Contacts the attending physician whenever the patient has ... Condition changes ... Completes comprehensive assessments including ... Follow-up when a significant change in condition occurs ...." 2. Review of an agency job description dated 05/08/2019, titled "Physical Therapist" stated "... Accurately assesses clients at admission and other required time points ... Reports changes in client condition as appropriate and in a timely manner ...." 3. Review of an agency job description dated (revised) 3/17/2019, titled "Primary Care Nurse (PCN)" stated "... The RN [registered nurse] is accountable for the client assessment ...." 4. Record review for patient #1 was completed on 2/10/2021, and again on 3/2/2021, start of care date 4/7/2020, primary diagnosis encounter for attention to cystostomy (suprapubic catheter- an opening in the lower abdomen where a tube is inserted directly into the bladder for drainage of urine). Review of a document titled "Home Health Certification and Plan of Care" for certification period 12/3/2020 - 1/31/2021, indicated skilled nursing services (effective 12/13/2020) once every 2 weeks for two weeks, then once every 4 weeks for 4 weeks, and 2 PRN (as needed) visits for bleeding, cardiac, catheter issues, diabetic, falls, pain, respiratory, or skin breakdown. The document failed to evidence the patient had current skin breakdown. Review of a document dated and signed by RN P on 12/30/2020, titled "Visit Note Report ... SN [skilled nurse] Subsequent Visit" evidenced no skin breakdown/open area(s), and a request was made for PT (physical therapy) to evaluate. Review of a document dated and signed by PT AA on 1/5/2021, titled "Visit Note Report ... PT Add-On Evaluation" stated "... Integumentary assessment findings: Stage 2 pressure sores along both lateral borders of sacrum [lower back] and dry skin causing itchiness all around that area ....", and evidenced the RN was notified. Review of a document dated and signed 1/6/2021, by the administrator/clinical manager titled "Physician Order" stated "... SN visit for wound/skin assessment ...." Review of a document dated and signed by LPN [licensed practical nurse] K on 1/7/2021, titled "Visit Note Report ... SN [skilled nurse] Subsequent Visit" stated "... Patient has an open area to L [left] upper buttock. It has been draining serous [a clear to pale yellow watery fluid that is found in the body] fluid. Right buttock has no open area or drainage. Buttocks are purple in color as patient does not move off of them ... This area is not listed in skin areas yet as this writer has no wound care orders as of yet. Approximately 3 cm [centimeters] x .05cm [sic] x 0.1cm. Patient unable to stand for long ... poor hydration ... tried to call physician [for orders] ...." The record failed to ensure a comprehensive re-assessment (including the administration of the OASIS) was completed on or after 1/6/2021 by a registered nurse. During an interview on 2/10/2021 at 12:40 PM, the administrator/clinical manager agreed the visit on 1/7/2021, made by a LPN should have been an RN comprehensive re-assessment visit due to the new skin breakdown. 5. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM, start of care date 1/22/2021, for certification period 1/22/2021 - 3/22/2021. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021. The patient's primary diagnosis was COVID-19, and other diagnoses included (but not limited to) pneumonia due to COVID-19, acute respiratory failure with hypoxia (deprivation of oxygen), acute on chronic systolic (congestive) heart failure, obstructive sleep apnea, type 2 diabetes with diabetic chronic kidney disease, non-ST elevation (NSTEMI) myocardial infarction (heart attack), constipation, long term (current) use of aspirin, and long term (current) use of anticoagulants. During the home visit, The patient presented sitting upright in his recliner with both legs elevated 90 degrees to his body, and feet rested on a firm, ridged pillow, which caused visible pitting into both posterior ankles. His abdomen was significantly distended. He was not wearing socks, and had no footwear visible in his immediate area. Both lower legs were extremely swollen, dark red, shiny, and had multiple small open areas. His left great toe presented with a black necrotic (dead body tissue) area approximately 1.0cm (centimeters) in diameter. His right 2nd toe was swollen, with a large blister present. He had a large SDTI (suspected deep tissue injury) on his right heel. The nurse assessed his buttocks/backside which revealed an open stage 2 pressure injury on his (left side) gluteal cleft (groove between the buttocks) just below his tailbone. The wound center was yellow, and the surrounding skin was dark purple. He did not have a pressure relieving cushion on his chair. He was wearing an incontinence brief, which was soiled. His skin on his bottom was moist and hyperpigmented (darker than normal color for patient). He indicated he had an old hospital bed that did not work (the head of the bed no longer elevated) so he was sleeping in his recliner since hospital discharge, as he had chest pain and difficulty breathing while in a supine (lying on back) position, his CPAP (Continuous Positive Airway Pressure machine that forces air into lungs, generally worn during sleep) was broken and he was waiting on a new one, his legs were like this since hospital discharge and getting worse, he had severe pain to the touch of the right heel and with any movement of both feet/lower legs, he had very limited ROM (range of motion) of both lower legs and feet due to swelling and severe pain, he had no footwear that fit him, and a nurse came out to see him for the first time last week (he also indicated he thought a nurse was coming from day one). He also indicated he had a heart attack while in the hospital, and he had ongoing chest pain and poor endurance, and he only changed his brief once daily, because it was "too hard to do more than that." Record review completed on 2/24/2021, and again on 3/2/2021, evidenced a document dated 1/22/2021, by PT X titled "Visit Note Report" which stated "... Visit Type: ... PT OASIS [Outcome and Assessment Information Set] Admission" indicated the patient had no pain, a standard mattress was appropriate at that time, had minimal to no risk for skin breakdown. Additionally, the document stated "... Was integumentary [skin] assessed? No ... Not applicable ...." The document evidenced the patient had no pain, and failed to evidence any lower extremity edema, skin breakdown or open skin area(s). The patient was subsequently seen in the emergency department on 2/17/2021 for swelling, draining, and intractable pain in both legs, and was prescribed antibiotics. He was seen in the emergency room again on 2/24/2021, and was admitted with complaint of shortness of breath, chest pain. He remained hospitalized upon survey exit dated 03/02/2021. Review of a document dated and signed 2/12/2021, by PT BB titled "Visit Note Report ... PT Subsequent Visit" indicated the patient had weeping edema to both lower extremities. Review of a document dated and signed 2/16/2021, by OT CC titled "Visit Note Report ... OT Subsequent Visit" indicated the patient had pain to right foot, 2nd and 3rd toes, burning, and stabbing. Review of a document dated and signed 2/18/2021, by OT CC titled "Visit Note Report ... OT Subsequent Visit" evidenced the patient was seen in the emergency department on 2/17/2021 for complaint of pain and legs seeping, and was sent home on oral antibiotics for "infection in legs" per patient report, and a referral for skilled nursing was requested. Review of a document dated and signed 2/20/2021, by RN J titled "Visit Note Report ... RN Add-On Evaluation" evidenced the patient had lower extremity edema, open seeping wounds to both lower legs, open wound to left buttock (Pressure ulcer), abnormal heart sounds, abnormal breath sounds, poor appetite, and poor hydration. The record failed to evidence a comprehensive re-assessment (including the administration of the OASIS) was completed for the patient's change in condition. During an interview on 2/24/2021 at 11:27 AM, family stated they called 911 about "10 minutes ago [2/24/2021]" for chest pain, and stated "... [chest pain] It's been off and on since he got home from the hospital ...." She also indicated he got up this morning, he wasn't feeling good, he (patient) "... took like 6 nitros [nitroglycerin for chest pain] no relief." She also indicated he was coughing quite a bit after the nurse left yesterday (2/23/2021), and he didn't have a good night. When asked if the patient complained of pain since he came home from the hospital prior to the initiation of home health services (start of care), she stated "Yes. His feet, he never feels good. So much pain." During an interview on 2/24/2021 at 2:25 PM, the administrator/clinical manager indicated an add-on evaluation did not include OASIS elements. When asked why a nurse wasn't referred upon start of care to complete a comprehensive assessment, (patient's primary diagnosis was COVID-19, and additional pertinent respiratory and cardiac diagnoses), the administrator/clinical manager stated "I can't answer that. I don't know." 6. Record review for patient #14 was completed on 3/2/2021, start of care date 1/28/2021, primary diagnosis sepsis (a serious infection that causes your immune system to attack your body) due to E coli (bacteria). Review of a document dated and signed 1/28/2021 by PT Y titled "Visit Note Report" stated "... Visit Type: ... PT OASIS Admission" stated "... Was integumentary assessed? No ... not appropriate at time of evaluation ....", indicated pain in spine, and need for OT (occupational therapy), skilled nursing and home health aide services. The document failed to evidence a complete comprehensive assessment was completed to evidence the patient's current health status. Review of a document dated and signed 1/30/2021, by RN U titled "Visit Note Report ... RN Add-On Evaluation" indicated no skin issues were identified, the patient had no pain, and no further nursing visits were necessary. Review of a document dated and signed 2/1/2021, by OT F titled "Visit Note Report ... OT Add-On Evaluation" stated "... Was integumentary [skin] assessed? No ....", and indicated the patient had left hip/groin pain. Review of a document dated and signed 2/2/2021, by PT Z titled "Visit Note Report ... PT Subsequent Visit" stated "... Pain on bed sore on bottom ....", and failed to evidence the patient's skin was assessed. Review of a document dated and signed 2/4/2021, by PT Z titled "Visit Note Report ... PT Subsequent Visit" stated "... Pain ... left buttocks pressure sore ... checked patient's buttocks while in bathroom and noted there looked like a stage II pressure sore [a partial thickness wound caused by pressure]; called MD and gor [sic] order for SN to eval ...." Review of a document dated and signed by RN J on 2/6/2021 titled "Visit Note Report ... RN Add-On Evaluation" evidenced the patient had poor hydration, was a high nutritional risk, and had a stage 2 pressure injury to the left buttock. The record failed to evidence a comprehensive re-assessment (including the administration of the OASIS) was completed for the patient's change in condition. 17-14-1(a)(1)(B)

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure it conformed with physician orders (G578); failed to ensure all changes in the patients condition was promptly relayed to the primary care physician (G590); failed to coordinate care amongst the different disciplines/entities that provided care to the agency's patients (G606); failed to ensure that all patients received written visit schedules (G614); failed to ensure that all patients had current/updated written medication schedule/instructions prepared by agency staff in the home (G616); and failed to ensure that all patients received a current/updated written plan of care (G618). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.60 Care planning, coordination, and quality of care. 17-14-1(a)(1)(H) 17-12-2(g) 17-12-2(h)

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 observation, record review and interview, the agency failed to conform with physician orders for 10 of 15 records reviewed (#1, 3, 6, 7, 8, 9, 10, 11, 14, 16). The findings include: 1. Review of an agency policy, with an approval/review date of 4/2020, titled "Care Management and the Plan of Care" stated "... The agency case manager (registered nurse or managing therapist) ... works with the attending physician to develop the plan of care ... notify the physician to obtain updated orders ... provides the patient with the services according to the ... plan of care ... plan of care specifies the care and services necessary ... all medications and treatments ...." 2. Review of an agency policy, with an approval/review date of 4/2020, titled "Physician Orders" stated "... Physician orders are required for services provided to agency patients ... orders are followed when administering medications or providing care treatment or services ... review all orders for accuracy prior to providing care, treatment or services ...." 3. Record review for patient #1 was completed on 2/10/2021, and again on 3/2/2021, start of care date 4/7/2020, primary diagnosis encounter for attention to cystostomy (suprapubic catheter- an opening in the lower abdomen where a tube is inserted directly into the bladder for drainage of urine). Review of a document titled "Home Health Certification and Plan of Care" for certification period 12/3/2020 - 1/31/2021, indicated skilled nursing services (effective 12/13/2020) once every 2 weeks for two weeks, then once every 4 weeks for 4 weeks, and 2 PRN (as needed) visits for bleeding, cardiac, catheter issues, diabetic, falls, pain, respiratory, or skin breakdown. The record evidenced the patient developed open wound(s) on 1/5/2021, an order for wound care was received on 1/7/2021, no wound care was performed during a nursing visit on 1/11/2021, and was eventually performed on 1/13/2021, 6 days after the order was received. Review of a document dated 1/5/2021, titled "Client Coordination Note Report" stated "... Stage 2 pressure sores each side of sacrum ...." Review of a document dated 1/7/2021, titled "Physician Order" stated "... SN to perform/teach wound care to client/caregiver. Cleanse left buttock wound with normal saline or wound cleanser, cover with duoderm bordered dressing on M/W/PRN [Monday/Wednesday/As Needed], all other days by client/caregiver ...." During an interview on 2/10/2021 at 12:40 PM, the administrator/clinical manager indicated it was clear the nurse did not review the record/order prior to her visit on 1/11/2021, as the order was received on 1/7/2021 (before the 1/11/2021 nursing visit). Review of a document dated 1/11/2021, titled "Visit Note Report ... SN Subsequent Visit" stated "... Wound care not provided: awaiting orders ...." Review of a document dated 1/13/2021, titled "Visit Note Report ... SN Subsequent Visit" stated "... supplies arrived today and area was cleaned and dressed per orders ...." 4. Record review for patient #3 was completed on 2/22/2021, and again on 3/2/2021, start of care date 10/10/2020, primary diagnosis urinary tract infection (UTI),site not specified, and other pertinent (but not limited to) diagnoses of cerebral palsy, morbid (severe) obesity, epilepsy, history of falling, and pacemaker. Review of a document titled "Home Health Certification and Plan of Care" for certification period 2/7/2021- 4/7/2021, indicated the patient received skilled nursing, PT services, and home health aide. The record evidenced the patient was hospitalized in observation status from 2/11/2021 - 2/14/2021. The record failed to evidence home health aide visits were made, and failed to evidence the patient's medications conformed with updated physician orders. Review of a document dated 2/14/2021, titled "Discharge Summary" from hospital M indicated medications including (but not limited to) Centrum Silver Men's oral tablet daily after breakfast, Docusate sodium (colace) 100mg (milligrams) twice daily after breakfast and dinner, and furosemide 40mg, 0.5 tab (20mg) daily after breakfast. Review of a document dated 2/15/2021 titled "Visit Note Report ... PT [physical therapy] Subsequent Visit" indicated no medication changes were identified. During an interview on 2/22/2021 at 1:24 PM, the administrator/clinical manager indicated no home health aide visits had been made as ordered. During an interview on 3/2/2021 at 2:30 PM, the administrator/clinical manager indicated she didn't see a medication reconciliation was completed after the patient returned home from the hospital on 2/14/2021, and agreed the medications listed in the EMR (electronic medical record) were not updated to match the medication changes on the hospital discharge documents. The EMR failed to evidence the Centrum Silver Men's oral tablet , indicated the docusate sodium Colace was twice a day "as needed" (last updated 2/2/2021, and the furosemide was 80mg, 0.5 tab (40mg) twice daily (last updated 2/2/2021). 5. During a home visit on 2/23/2021 at 10:00 AM with patient #6, review of the patient's home folder evidenced a document from wound clinic A dated 2/18/2021, titled "Physician Orders". The document indicated wound care orders to the left leg included (but not limited to) the placement of adaptic (vaseline impregnated gauze) to the wound bed (to prevent the foam dressing from sticking the the wound bed), and zinc (protective barrier cream) to red areas (on the surrounding skin). During observation of wound care, the nurse failed to apply adaptic to the wound bed, and failed to apply zinc to the red areas. After wound care was completed, the nurse reviewed the EMR, indicated she made an error, she didn't apply the adaptic prior to the application of foam, the agency got the order yesterday (2/22/2021), she didn't have any adaptic in her bag, she would notify the wound clinic, and would come back later (same day) to redo dressing. The patient indicated he did not want the dressing changed due to pain during the procedure, and would wait until the next time it was due to be changed. Review of a document dated 2/20/2021, titled "Visit Note Report ... SN Subsequent Visit" failed to evidence the nurse applied adaptic to the wound bed prior to the application of the foam, and failed to apply zinc to the red areas. During an interview on 2/24/2021 at 11:18 AM, the administrator/clinical manager agreed the current wound care order dated 2/18/2021, was in the home folder (readily accessible to nurses prior to providing wound care), and the agency failed to conform with physician orders on nursing visits completed 2/20/2021 and 2/23/2021. 6. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM , start of care date 1/22/2021, for certification period 1/22/2021 - 3/22/2021. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021, for wounds. The patient's primary diagnosis was COVID-19, and other diagnoses included (but not limited to) pneumonia due to COVID-19, acute respiratory failure with hypoxia (deprivation of oxygen), acute on chronic systolic (congestive) heart failure, obstructive sleep apnea, type 2 diabetes with diabetic chronic kidney disease, non-ST elevation (NSTEMI) myocardial infarction (heart attack), constipation, long term (current) use of aspirin, and long term (current) use of anticoagulants. Record review completed on 2/24/2021, and again on 3/2/2021, evidenced a document dated 1/22/2021, by PT X titled "Visit Note Report" which stated "... Visit Type: ... PT OASIS [Outcome and Assessment Information Set] Admission" evidenced the patient had no pain, and failed to evidence any lower extremity edema, skin breakdown or open skin area(s). The patient was subsequently seen in the emergency department on 2/17/2021, for swelling, draining, and intractable pain in both legs, and was prescribed antibiotics. He was seen in the emergency room again on 2/24/2021, and was admitted with complaint of shortness of breath, and chest pain. He remained hospitalized upon survey exit on 03/02/2021. Review of a document signed and dated 2/19/2021, by PT BB titled "Physician Order" stated "... PT to do dressing change elastic bandage as needed B [both] LE [lower extremities] if legs are soaked from weeping edema ...." Review of a document dated and signed 2/19/2021, by PT BB titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had weeping edema to both lower extremities, failed to evidence the integrity of the dressings/bandages, and failed to evidence the bandages were changed as ordered by the physician. 7. Record review for patient #8 was completed on 2/24/2021, and again on 3/2/2021, start of care date 6/11/2016, primary diagnosis quadriplegia (paralyzed from the neck down), unspecified, and other pertinent (but not limited to) diagnoses pressure ulcer left buttock, rheumatoid arthritis, depression, anxiety, tobacco use, and diabetes. Review of a document titled "Home Health Certification and Plan of Care" for certification period 6/11/2016 - 8/9/2016, indicated (but not limited to) skilled nursing orders for wound care 3 times per week, foley catheter changes, patient/caregiver teaching related to wound care and management of health conditions, and caregiver to provide wound care on non-nursing visit days. Review of a document dated 6/11/2016, titled ""Visit Note Report ... RN OASIS Admission" failed to evidence the nurse taught the caregiver proper wound care procedures as ordered by the physician so the caregiver could perform the treatment on non-nursing visit days. Review of a document dated 6/13/2016 titled ""Visit Note Report ... SN Subsequent Visit" failed to evidence wound care was performed as ordered on the plan of care. Review of a document dated 6/20/2016 titled ""Visit Note Report ... SN Subsequent Visit - As Needed" stated "... Are wound care orders being followed? No ....", and failed to evidence wound care was performed as ordered on the plan of care. 8. Record review for patient #9 was completed on 3/2/2021, start of care date 7/23/2020, evidenced a document titled "Home Health Certification and Plan of Care" for dates 9/21/2020 - 11/19/2020, with primary diagnosis encounter for attention to cysts, other pertinent diagnoses including (but not limited to) laceration without foreign body of left upper arm, diabetes, heart failure, and indicated skilled nursing visits 1 time week of 9/20/2020, 2 times week of 9/27/2020, then every 2 weeks for 2 weeks, then once every 5 weeks, and 2 extra visits for unplanned needs. Review of the record evidenced 2 nursing visits were completed the week of 9/20/2020. 9. Record review for patient #10 was completed on 3/2/2021, start of care date 10/8/2019, evidenced a document titled "Home Health Certification and Plan of Care" for dates 2/5/2020 - 4/4/2020, with primary diagnosis disruption of external operation (surgical) wound, other (but not limited to) pertinent diagnoses hypertension (high blood pressure), chronic pain, depression, anxiety, and long term (current) use of anticoagulants. The document evidenced orders for skilled nursing twice weekly beginning week of 2/9/2020. Only 1 visit was made week of 3/8/2020. Additionally, the document indicated skilled nurse to perform PT/INR via finger stick (a blood test to monitor therapeutic anticoagulant drug levels) every Monday. Review of a document dated 2/3/2020 (Monday) titled "Visit Note Report ... RN Recert with Skill" evidenced a PT/INR was completed. Review of a document dated 2/6/2020 (Thursday) titled "Visit Note Report ... RN Subsequent Visit" evidenced a PT/INR was completed (no order). Review of a document dated 2/10/2020 (Monday) titled "Visit Note Report ... RN Subsequent Visit" evidenced a PT/INR was completed. No nursing visit was made on 2/17/2020 (Monday- No PT/INR completed). Review of a document dated 2/18/2020 (Tuesday) titled "Visit Note Report ... RN Subsequent Visit" evidenced a PT/INR was completed (no order). Review of a document dated 2/21/2020 signed by the certifying physician on 3/2/2020 titled "Physician Order" stated "... Recheck INR on 2/27/2020 ...." (Record failed to evidence INR was checked on 2/27/2020.) Review of a document dated 2/26/2020 (not signed by a physician) titled "Physician Order" stated "... Check INR weekly ... patient prefers ... Fridays, per nursing ...." Review of a document dated 2/28/2020 (Friday) titled "Visit Note Report ... RN Subsequent Visit" Record evidenced a PT/INR was completed with critical result of 7.0 (2.0-3.0 is desired therapeutic range, and result of 7.0 could cause spontaneous bleeding/hemorrhage), and patient had lab drawn at infusion clinic. 10. Record review for patient #11 was completed on 3/2/2021, start of care date 7/14/2016, evidenced a document titled "Home Health Certification and Plan of Care" for dates 7/14/2016 - 9/11/2016, with primary diagnosis encounter for fitting and adjustment of urinary device, other pertinent diagnoses including (but not limited to) enlarged prostate, and urine retention. The document evidenced skilled nursing monthly for urinary catheter changes, with 3 extra visits as needed for catheter complications. Review of a document effective date 7/31/2016, signed by the physician 8/10/2016 titled "Physician Verbal Order" indicated PT visit frequency once per week for 1 week, then twice weekly for 3 weeks. The record failed to evidence 2 PT visits were made during the week of 8/14/2016 as ordered by the physician. 11. Record review for patient #14 was completed on 3/2/2021, start of care date 1/28/2021, evidenced a document titled "Home Health Certification and Plan of Care" for dates 1/28/2021 - 3/28/2021, with primary diagnosis sepsis (a serious infection that causes your immune system to attack your body) due to E coli (bacteria), evidenced (but not limited to) home health aide (beginning week of 1/31/2021) once weekly for 4 weeks. Review of a document dated Friday, 2/12/2021 titled "Client Coordination Note Report" evidenced a home health aide visit was missed do to a "scheduling conflict", and no other aide visit was made that week. 12. Record review for patient #16 was completed on 3/2/2021, start of care date 1/7/2016, evidenced a document titled "Home Health Certification and Plan of Care" for dates 2/9/2021 - 4/9/2021, with primary neuromuscular dysfunction of bladder, evidenced (but not limited to) skilled nursing visits 2 times the first week, then once weekly for 3 weeks, and home health aide visits once the first week, then twice weekly for 8 weeks. The record evidenced only 1 skilled nursing visit was made the first week, and only 1 home health aide visit was made on the second week. 17-14-1(a)(1)(H)

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 observation, record review and interview, the agency failed to ensure the physician was notified of changes in the patient's condition for 6 of 15 records reviewed (#3, 7, 8, 9). Findings include: 1. Review of an agency policy approval/reviewed date 4/2020 titled "Care Management and the Plan of Care" stated "... Agency staff maintain liaison among disciplines to ensure that coordinated care is provided and supports the objectives in the plan of care ... regularly coordinates patient care activities with the physician and/or other members of the health care team and documents communications ... also shares and receives patient information with other providers of care, treatment or services ...." 2. Record review for patient #3 was completed on 2/22/2021 and again on 3/2/2021, start of care date 10/10/2020, primary diagnosis urinary tract infection (UTI), site not specified, and other pertinent (but not limited to) diagnoses of cerebral palsy, morbid (severe) obesity, epilepsy, history of falling, and pacemaker. Review of a document titled "Home Health Certification and Plan of Care" for certification period 2/7/2021- 4/7/2021 indicated the patient received skilled nursing and PT services, and home health aide. The record evidenced the patient was hospitalized in observation status 2/11/2021 - 2/14/2021. Review of a document dated 2/14/2021 titled "Discharge Summary" from hospital M indicated medications including (but not limited to) Centrum Silver Men's oral tablet daily after breakfast, Docusate sodium (colace) 100mg (milligrams) twice daily after breakfast and dinner, and furosemide 40mg, 0.5 tab (20mg) daily after breakfast. Review of a document dated 2/15/2021 titled "Visit Note Report ... PT [physical therapy] Subsequent Visit" indicated no medication changes were identified (there were medication changes), and the record failed to evidence the physician was notified for post-hospitalization medication reconciliation for the new/changed medications. During an interview on 3/2/2021 at 2:30 PM, the administrator/clinical manager indicated she didn't see a medication reconciliation was completed after the patient returned home from the hospital on 2/14/2021, and agreed the medications listed in the EMR (electronic medical record) were not updated to match the medication changes on the hospital discharge documents. 3. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM, start of care date 1/22/2021, for certification period 1/22/2021 - 3/22/2021. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021, for wounds. The patient's primary diagnosis was COVID-19, and other diagnoses, which included (but was not limited to), pneumonia due to COVID-19, acute respiratory failure with hypoxia (deprivation of oxygen), acute on chronic systolic (congestive) heart failure, obstructive sleep apnea, type 2 diabetes with diabetic chronic kidney disease, non-ST elevation (NSTEMI) myocardial infarction (heart attack), constipation, long term (current) use of aspirin, and long term (current) use of anticoagulants. Record review completed on 2/24/2021, and again on 3/2/2021, evidenced a document dated 1/22/2021, by PT X titled "Visit Note Report" which stated "... Visit Type: ... PT OASIS [Outcome and Assessment Information Set] Admission" evidenced the patient had no pain, and failed to evidence any lower extremity edema, skin breakdown or open skin area(s). Review of a document dated 2/4/2021, titled "Visit Note Report ... PT Subsequent Visit" evidenced medication changes were identified during the visit, failed to evidence what medications(s) were changed, and evidenced no care coordination with a nurse/clinical manager or physician occurred, and stated "... care coordination ... NO ...." Review of a document dated 2/6/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced medication changes were identified during the visit, failed to evidence what medications(s) were changed, and evidenced no care coordination with a nurse/clinical manager or physician occurred, and stated "... care coordination ... NO ...." Review of a document dated 2/8/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had bilateral lower extremity edema (swelling), and evidenced no care coordination with a nurse/clinical manager or physician occurred, and stated "... care coordination ... NO ...." Review of a document dated 2/11/2021 titled "Visit Note Report ... OT Add-On Evaluation" evidenced the patient complained of fatigue and shortness of breath with exertion, mild foot pain (no complaint of pain prior to this visit per record review), the patient stated "... Feels like skin is stretching [describing his pain] ....", red areas were assessed on skin (patient explained it was an allergic reaction to lotion), and evidenced no care coordination with a nurse/clinical manager or physician occurred. to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/12/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had weeping edema to both lower extremities, medication changes were identified during the visit, a medication reconciliation was performed, failed to evidence what medications(s) were changed, and evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/16/2021 titled "Visit Note Report ... OT Subsequent Visit" evidenced the patient's pain was described as "burning ... stabbing", rated from 5-7 (on a pain scale 0-10, with 0 being no pain, and 10 being the most severe), pain was located to the right foot, 2nd and 3rd toes, patient was weak and unsteady, and evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/18/2021 titled "Visit Note Report ... OT Subsequent Visit" evidenced the patient was seen in the emergency department on 2/17/2021 for complaint of intractable pain in legs (10/10), legs seeping, and was given antibiotics for infection in legs per patient report. Review of a document dated 2/18/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient was seen in the emergency department on 2/17/2021 (via ambulance) for bilateral lower extremity weeping edema, blisters on right foot 2nd toe, and had a new antibiotic. The document stated "... The dressing was soaked totally and needed to be replaced, PT recommended to request daughter to replace soaked dressing when she gets home ...." The document evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/19/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had weeping edema to both lower extremities, failed to evidence the integrity of the dressings/bandages, evidenced the patient had pain 8/10 on pain scale, and pain to touch. The document evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." During an interview on 2/24/2021 at 11:27 AM family stated they called 911 about "10 minutes ago [2/24/2021]" for chest pain, and stated "... [chest pain] It's been off and on since he got home from the hospital ...." She also indicated he got up this morning, he wasn't feeling good, he (patient) "... took like 6 nitros [nitroglycerin for chest pain] no relief." She also indicated he was coughing quite a bit after the nurse left yesterday (2/23/2021), and he didn't have a good night. When asked if the patient complained of pain since he came home from the hospital prior to the initiation of home health services (start of care), she stated "Yes. His feet, he never feels good. So much pain." The patient was subsequently seen in the emergency department on 2/17/2021 for swelling, draining, and intractable pain in both legs, and was prescribed antibiotics. He was seen in the emergency room again on 2/24/2021 and was admitted with complaint of shortness of breath, heart failure, and chest pain. He remained hospitalized upon survey exit. 4. Record review for patient #8 was completed on 2/24/2021 and again on 3/2/2021, start of care date 6/11/2016, primary diagnosis quadriplegia (paralyzed from the neck down), unspecified, and other pertinent (but not limited to) diagnoses of, pressure ulcer left buttock, rheumatoid arthritis, depression, anxiety, tobacco use, and diabetes. Review of the document titled "Home Health Certification and Plan of Care" for certification period 6/11/2016 - 8/9/2016, indicated (but was not limited to) skilled nursing orders for wound care 3 times per week, foley catheter changes, patient/caregiver teaching related to wound care, management of health conditions, and caregiver was to provide wound care on non-nursing visit days. Review of a document dated 6/13/2016, titled ""Visit Note Report ... SN Subsequent Visit" stated "... Usual blood sugar readings: "200 to 300 Am fasting. Some times [sic] over 500 late in the day...." and evidenced the wound on the right upper buttock was worse, a new wound on the left posterior lower buttock, a new wound on the sacrum, a stool sample was obtained, and evidenced no care coordination with the physician occurred to report high blood sugar readings and worsening/new wounds. This document stated "... care coordination ... not applicable ...." Review of a document dated on 6/20/2016, titled "Visit Note Report ... SN Subsequent Visit - As Needed" evidenced the visit was for patient complaint of occluded urinary catheter, urine was dark amber colored, and stated "... Upon arrival after milking foley urine flowed free ...." The document failed to evidence coordination with the physician for signs of UTI (urinary tract infection) such as dark colored urine and occluded catheter, and stated "... care coordination ... NO ...." 5. Record review for patient #9 was completed on 3/2/2021, start of care date 7/23/2020, evidenced a document titled "Home Health Certification and Plan of Care" for dates 9/21/2020 - 11/19/2020, with primary diagnosis encounter for attention to cystsostomy (urinary drainage tube), other pertinent diagnoses including (but not limited to), laceration without foreign body of left upper arm, diabetes, heart failure, and indicated the patient received skilled nursing services. Review of a document titled "Home Health Certification and Plan of Care" for certification period 9/21/2020 - 11/19/2020 failed to evidence the presence of a cardiac pacemaker. Review of a document dated 9/22/2020 titled "Visit Note Report ... RN Recert with Skill" stated "... Cardiovascular assessment ... WNL [within normal limits] ... indwelling/suprapubic catheter ... leaking from penis ... mental status ... WNL ... alert ... oriented to person ... oriented to place ... forgetful ..." The document failed to evidence presence of a cardiac pacemaker. Review of a document dated 9/25/2020 titled "Visit Note Report ... SN Subsequent Visit" stated "... Cardiovascular assessment ... pacemaker ... Indicate type of pacemaker and rate ... unknown ....", evidenced purulent (indicative of infection) drainage from arm wound, and evidenced no care coordination with a nurse/clinical manager or physician occurred for care coordination regarding the patient's pacemaker and purulent drainage, and stated "... care coordination ... NO ...." Review of a document dated 9/29/2020 titled "Visit Note Report ... SN Subsequent Visit" evidenced urine was dark amber color, the patient was confused, and evidenced no care coordination with a nurse/clinical manager or physician occurred for care coordination regarding the patient's signs and symptoms of UTI (dark amber color urine, confusion), and stated "... care coordination ... NO ...." Review of a document dated 10/2/2020, titled "Client Coordination Note Report" stated "... Son expressed concerned [sic] that patient has come down with a UTI due to increased confusion and hallucinations ...." Review of a document dated 10/2/2020 titled "Visit Note Report ... SN Subsequent Visit" stated "... Cardiovascular assessment ... edema ... lower right ... lower left ... cough ... son [name] wants to get a UA [urinalysis lab test] to rule out a UTI ...." Review of an additional document dated 10/2/2020, titled "Client Coordination Note Report" stated "... Went back to patient home and obtained a urine sample. Dropped sample off ...." Review of a document dated 10/14/2020, titled "Visit Note Report ... SN Subsequent Visit" stated "... Cardiovascular assessment ... edema ... lower right ... lower left ... cough ... confused ....", and evidenced no care coordination with a nurse/clinical manager or physician occurred for care coordination regarding the patient's edema, cough, confusion, or urinalysis follow up, and stated "... care coordination ... NO ...." Review of a document received on 3/1/2021, (not part of patient's agency clinical record) dated and signed by physician N on 10/20/2020, titled "Physician New Clinic Note" stated "... I [physician N] reviewed patient's urine culture from 2 days ago showing a Pseudomonas infection that is resistant to oral antibiotics ... I will send him down to the emergency room where he will likely benefit from an admission and treatment for urosepsis ...." During an interview on 3/1/2021 at 11:04 AM, the patient's family indicated the reason the patient was discharged in October (2020), was due to hospitalization for a bad infection, he required IV [intravenous] antibiotics, then went to a skilled nursing facility for rehab, and when he got out, they (home health agency) wouldn't see him again because of their caseload. He also indicated the patient had recurrent UTIs, and whenever he got a UTI, he got very confused. Finally, he indicated the patient had a pacemaker, and stated "Yes, left side ....", indicated it paced at 70 bpm (beats per minute), it was inserted about a year ago or two, about 8 years left on a 10 year battery, it was checked every 6 months, and he took him to an outpatient facility for the checks. During an interview on 3/2/2021 at 2:30 PM, the administrator/clinical manager indicated the agency didn't usually call for lab results, the lab faxed them to the agency if they were critical, the agency has identified a problem with UTIs, and lack of care coordination. RN B indicated she didn't see follow up for UA [urinalysis] results or for pacemaker in the patient's record. 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 observation, record review and interview, the home health agency failed to coordinate care amongst the different disciplines/entities that provided care to the agency's patients for 6 of 15 records reviewed (#1, 3, 6, 7, 8, 9). The findings include: 1. Review of an agency policy, with an approval/reviewed date of 4/2020 titled "Care Management and the Plan of Care" stated "... Agency staff maintain liaison among disciplines to ensure that coordinated care is provided and supports the objectives in the plan of care ... regularly coordinates patient care activities with the physician and/or other members of the health care team and documents communications ... also shares and receives patient information with other providers of care, treatment or services ...." 2. Record review for patient #1 was completed on 2/10/2021 and again on 3/2/2021, start of care date 4/7/2020, primary diagnosis encounter for attention to cystostomy (suprapubic catheter- an opening in the lower abdomen where a tube is inserted directly into the bladder for drainage of urine). Review of a document titled "Home Health Certification and Plan of Care" for certification period 12/3/2020 - 1/31/2021 indicated skilled nursing services (effective 12/13/2020) once every 2 weeks for two weeks, then once every 4 weeks for 4 weeks, and 2 PRN (as needed) visits for bleeding, cardiac, catheter issues, diabetic, falls, pain, respiratory, or skin breakdown. The clinical record evidenced the patient developed open wound(s) on 1/5/2021, an order for wound care was received on 1/7/2021, and no wound care was performed during a nursing visit on 1/11/2021. Review of a document dated 1/5/2021, titled "Client Coordination Note Report" evidenced new wounds were identified, and stated "... Stage 2 pressure sores each side of sacrum ...." Review of a document dated and signed by the administrator/clinical manager 1/7/2021, titled "Physician Order" stated "... SN [skilled nurse] to perform/teach wound care to client/caregiver. Cleanse left buttock wound with normal saline or wound cleanser, cover with duoderm bordered dressing on M/W/PRN [Monday/ Wednesday/as needed] , all other days by client/caregiver ...." Review of a document signed and dated 1/11/2021 by LPN [licensed practical nurse] K titled "Visit Note Report ... SN Subsequent Visit" stated "... Wound care not provided: awaiting orders ...." During an interview on 2/10/2021 at 12:40 PM, the administrator/clinical manager indicated it was clear the nurse did not review the record/order prior to her visit, and stated "Yeah, there's no coordination from RN [registered nurse] to LPN for wound orders." RN B (Performance Improvement/PI Manager and Educator) and administrator/clinical manager agreed there was an issue with interdisciplinary communication. PT [physical therapist] A (Clinical Manager) also indicated it was a problem. 3. Record review for patient #3 was completed on 2/22/2021 and again on 3/2/2021, start of care date 10/10/2020, primary diagnosis urinary tract infection (UTI),site not specified, and other pertinent (but not limited to) diagnoses of cerebral palsy, morbid (severe) obesity, epilepsy, history of falling, and pacemaker. Review of a document titled "Home Health Certification and Plan of Care" for certification period 2/7/2021- 4/7/2021, indicated the patient received skilled nursing, PT services, and home health aide. The clinical record evidenced the patient was hospitalized in observation status 2/11/2021 - 2/14/2021. Review of a document dated 2/9/2021, titled "Visit Note Report ... SN Subsequent Visit" evidenced the nurse performed an aide supervisory visit, but there were no aide visits made. Review of a document dated 2/14/2021, titled "Discharge Summary" from hospital M, indicated medications including (but not limited to) Centrum Silver Men's oral tablet daily after breakfast, Docusate sodium (colace) 100mg (milligrams) twice daily after breakfast and dinner, and furosemide 40mg, 0.5 tab (20mg) daily after breakfast were prescribed. Review of a document dated 2/15/2021, titled "Visit Note Report ... PT Subsequent Visit" indicated no medication changes were identified, the patient sustained a fall on 2/14/2021, and failed to evidence care coordination with an RN/Clinical Supervisor for post-hospitalization medication reconciliation or report of fall. During an interview on 2/22/2021 at 1:24 PM, the administrator/clinical manager indicated no home health aide visits had been made as ordered, and RN B indicated there wasn't follow up with a nurse for the fall. During an interview on 3/2/2021 at 2:30 PM, the administrator/clinical manager indicated she didn't see a medication reconciliation was completed after the patient returned home from the hospital on 2/14/2021, and agreed the medications listed in the EMR (electronic medical record) were not updated to match the medication changes on the hospital discharge documents. 4. Record review for patient #6 was completed on 2/26/2021 and again on 3/2/2021, start of care date 1/31/2021, for certification period 1/31/2021 - 3/31/2021, which evidenced the patient received skilled nursing services for NPWT (negative pressure wound therapy), and was seen by wound clinic A every Thursday. During a home visit on 2/23/2021 at 10:00 AM, review of the patient's home folder evidenced a document from wound clinic A dated 2/18/2021, titled "Physician Orders". The document evidenced wound care orders to the left leg which included (but was not limited to), the placement of adaptic (vaseline impregnated gauze) to the wound bed (to prevent the foam dressing from sticking the the wound bed), and zinc (protective barrier cream) to red areas (on the surrounding skin). During observation of wound care, the nurse failed to apply adaptic to the wound bed, and failed to apply zinc to the red areas. After wound care was completed, the nurse reviewed the EMR, indicated she made an error, she didn't apply the adaptic prior to the application of foam, and the agency got the order yesterday (2/22/2021). Review of a document dated 2/20/2021, titled "Visit Note Report ... SN Subsequent Visit" failed to evidence the nurse applied adaptic to the wound bed prior to the application of the foam, and failed to apply zinc to the red areas as indicated in the physician order. During an interview on 2/24/2021 at 11:18 AM, the administrator/clinical manager agreed the current wound care order dated 2/18/2021, was in the home folder (readily accessible to nurses prior to providing wound care), and the agency failed to coordinate wound care treatment orders for skilled nurse visits 2/20/2021 and 2/23/2021. 5. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM, start of care date 1/22/2021, for certification period 1/22/2021 - 3/22/2021. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021, for wounds. The patient's primary diagnosis was COVID-19, and other diagnoses, which included (but was not limited to), pneumonia due to COVID-19, acute respiratory failure with hypoxia (deprivation of oxygen), acute on chronic systolic (congestive) heart failure, obstructive sleep apnea, type 2 diabetes with diabetic chronic kidney disease, non-ST elevation (NSTEMI) myocardial infarction (heart attack), constipation, long term (current) use of aspirin, and long term (current) use of anticoagulants. Record review completed on 2/24/2021, and again on 3/2/2021, evidenced a document dated 1/22/2021, by PT X titled "Visit Note Report" which stated "... Visit Type: ... PT OASIS [Outcome and Assessment Information Set] Admission" evidenced the patient had no pain, and failed to evidence any lower extremity edema, skin breakdown or open skin area(s). Review of a document dated 2/4/2021, titled "Visit Note Report ... PT Subsequent Visit" evidenced medication changes were identified during the visit, failed to evidence what medications(s) were changed, and evidenced no care coordination with a nurse/clinical manager or physician occurred, and stated "... care coordination ... NO ...." Review of a document dated 2/6/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced medication changes were identified during the visit, failed to evidence what medications(s) were changed, and evidenced no care coordination with a nurse/clinical manager or physician occurred, and stated "... care coordination ... NO ...." Review of a document dated 2/8/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had bilateral lower extremity edema (swelling), and evidenced no care coordination with a nurse/clinical manager or physician occurred, and stated "... care coordination ... NO ...." Review of a document dated 2/11/2021 titled "Visit Note Report ... OT Add-On Evaluation" evidenced the patient complained of fatigue and shortness of breath with exertion, mild foot pain (no complaint of pain prior to this visit per record review), the patient stated "... Feels like skin is stretching [describing his pain] ....", red areas were assessed on skin (patient explained it was an allergic reaction to lotion), and evidenced no care coordination with a nurse/clinical manager or physician occurred. to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/12/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had weeping edema to both lower extremities, medication changes were identified during the visit, a medication reconciliation was performed, failed to evidence what medications(s) were changed, and evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/16/2021 titled "Visit Note Report ... OT Subsequent Visit" evidenced the patient's pain was described as "burning ... stabbing", rated from 5-7 (on a pain scale 0-10, with 0 being no pain, and 10 being the most severe), pain was located to the right foot, 2nd and 3rd toes, patient was weak and unsteady, and evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/18/2021 titled "Visit Note Report ... OT Subsequent Visit" evidenced the patient was seen in the emergency department on 2/17/2021 for complaint of intractable pain in legs (10/10), legs seeping, and was given antibiotics for infection in legs per patient report. Coordination did occur this visit with RN clinical manager to request a nurse. Review of a document dated 2/18/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient was seen in the emergency department on 2/17/2021 (via ambulance) for bilateral lower extremity weeping edema, blisters on right foot 2nd toe, and had a new antibiotic. The document stated "... The dressing was soaked totally and needed to be replaced, PT recommended to request daughter to replace soaked dressing when she gets home ...." The document evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." Review of a document dated 2/19/2021 titled "Visit Note Report ... PT Subsequent Visit" evidenced the patient had weeping edema to both lower extremities, failed to evidence the integrity of the dressings/bandages, evidenced the patient had pain 8/10 on pain scale, and pain to touch. The document evidenced no care coordination with a nurse/clinical manager or physician occurred to report assessment findings, and stated "... care coordination ... NO ...." During an interview on 2/24/2021 at 11:27 AM family stated they called 911 about "10 minutes ago [2/24/2021]" for chest pain, and stated "... [chest pain] It's been off and on since he got home from the hospital ...." She also indicated he got up this morning, he wasn't feeling good, he (patient) "... took like 6 nitros [nitroglycerin for chest pain] no relief." She also indicated he was coughing quite a bit after the nurse left yesterday (2/23/2021), and he didn't have a good night. When asked if the patient complained of pain since he came home from the hospital prior to the initiation of home health services (start of care), she stated "Yes. His feet, he never feels good. So much pain." The patient was subsequently seen in the emergency department on 2/17/2021 for swelling, draining, and intractable pain in both legs, and was prescribed antibiotics. He was seen in the emergency room again on 2/24/2021 and was admitted with complaint of shortness of breath, heart failure, and chest pain. He remained hospitalized upon survey exit. 6. Record review for patient #8 was completed on 2/24/2021 and again on 3/2/2021, start of care date 6/11/2016, primary diagnosis quadriplegia (paralyzed from the neck down), unspecified, and other pertinent (but not limited to) diagnoses of, pressure ulcer left buttock, rheumatoid arthritis, depression, anxiety, tobacco use, and diabetes. Review of the document titled "Home Health Certification and Plan of Care" for certification period 6/11/2016 - 8/9/2016, indicated (but was not limited to) skilled nursing orders for wound care 3 times per week, foley catheter changes, patient/caregiver teaching related to wound care, management of health conditions, and caregiver was to provide wound care on non-nursing visit days. Review of a document dated 6/13/2016, titled ""Visit Note Report ... SN Subsequent Visit" stated "... Usual blood sugar readings: "200 to 300 Am fasting. Some times [sic] over 500 late in the day...." and evidenced the wound on the right upper buttock was worse, a new wound on the left posterior lower buttock, a new wound on the sacrum, a stool sample was obtained, and evidenced no care coordination with a nurse/clinical manager or physician occurred to report high blood sugar readings and worsening/new wounds. This document stated "... care coordination ... not applicable ...." Review of a document dated on 6/20/2016, titled "Visit Note Report ... SN Subsequent Visit - As Needed" evidenced the visit was for patient complaint of occluded urinary catheter, urine was dark amber colored, and stated "... Upon arrival after milking foley urine flowed free ...." The document failed to evidence coordination with a nurse/clinical manager or physician for signs of UTI (urinary tract infection) such as dark colored urine and occluded catheter, and stated "... care coordination ... NO ...." 7. Record review for patient #9 was completed on 3/2/2021, start of care date 7/23/2020, evidenced a document titled "Home Health Certification and Plan of Care" for dates 9/21/2020 - 11/19/2020, with primary diagnosis encounter for attention to cystsostomy (urinary drainage tube), other pertinent diagnoses including (but not limited to), laceration without foreign body of left upper arm, diabetes, heart failure, and indicated the patient received skilled nursing services. Review of a document titled "Home Health Certification and Plan of Care" for certification period 9/21/2020 - 11/19/2020 failed to evidence the presence of a cardiac pacemaker. Review of a document dated 9/22/2020 titled "Visit Note Report ... RN Recert with Skill" stated "... Cardiovascular assessment ... WNL [within normal limits] ... indwelling/suprapubic catheter ... leaking from penis ... mental status ... WNL ... alert ... oriented to person ... oriented to place ... forgetful ..." The document failed to evidence presence of a cardiac pacemaker. Review of a document dated 9/25/2020 titled "Visit Note Report ... SN Subsequent Visit" stated "... Cardiovascular assessment ... pacemaker ... Indicate type of pacemaker and rate ... unknown ....", evidenced purulent (indicative of infection) drainage from arm wound, and evidenced no care coordination with a nurse/clinical manager or physician occurred for care coordination regarding the patient's pacemaker and purulent drainage, and stated "... care coordination ... NO ...." Review of a document dated 9/29/2020 titled "Visit Note Report ... SN Subsequent Visit" evidenced urine was dark amber color, the patient was confused, and evidenced no care coordination with a nurse/clinical manager or physician occurred for care coordination regarding the patient's signs and symptoms of UTI (dark amber color urine, confusion), and stated "... care coordination ... NO ...." Review of a document dated 10/2/2020, titled "Client Coordination Note Report" stated "... Son expressed concerned [sic] that patient has come down with a UTI due to increased confusion and hallucinations ...." Review of a document dated 10/2/2020 titled "Visit Note Report ... SN Subsequent Visit" stated "... Cardiovascular assessment ... edema ... lower right ... lower left ... cough ... son [name] wants to get a UA [urinalysis lab test] to rule out a UTI ...." Review of an additional document dated 10/2/2020, titled "Client Coordination Note Report" stated "... Went back to patient home and obtained a urine sample. Dropped sample off ...." Review of a document dated 10/14/2020, titled "Visit Note Report ... SN Subsequent Visit" stated "... Cardiovascular assessment ... edema ... lower right ... lower left ... cough ... confused ....", and evidenced no care coordination with a nurse/clinical manager or physician occurred for care coordination regarding the patient's edema, cough, confusion, or urinalysis follow up, and stated "... care coordination ... NO ...." Review of a document received on 3/1/2021, (not part of patient's agency clinical record) dated and signed by physician N on 10/20/2020, titled "Physician New Clinic Note" stated "... I [physician N] reviewed patient's urine culture from 2 days ago showing a Pseudomonas infection that is resistant to oral antibiotics ... I will send him down to the emergency room where he will likely benefit from an admission and treatment for urosepsis ...." During an interview on 3/1/2021 at 11:04 AM, the patient's family indicated the reason the patient was discharged in October (2020), was due to hospitalization for a bad infection, he required IV [intravenous] antibiotics, then went to a skilled nursing facility for rehab, and when he got out, they (home health agency) wouldn't see him again because of their caseload. He also indicated the patient had recurrent UTIs, and whenever he got a UTI, he got very confused. Finally, he indicated the patient had a pacemaker, and stated "Yes, left side ....", indicated it paced at 70 bpm (beats per minute), it was inserted about a year ago or two, about 8 years left on a 10 year battery, it was checked every 6 months, and he took him to an outpatient facility for the checks. During an interview on 3/2/2021 at 2:30 PM, the administrator/clinical manager indicated the agency didn't usually call for lab results, the lab faxed them to the agency if they were critical, the agency has identified a problem with UTIs, and lack of care coordination. RN B indicated she didn't see follow up for UA [urinalysis] results or for pacemaker in the patient's record. 17-12-2(g) 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 agency failed to ensure that all patients received written visit schedules, which included the frequency of visits by all agency staff assigned to the patients for 5 of 7 home visits observed (#1, 5, 6, 7, 13). The findings include: 1. Review of an agency policy, with an approval/review date of 4/2020, titled "2.1 Patient Rights and Responsibilities" stated "... the patient is informed both verbally and in writing of all rights including: ... the types (disciplines) of the caregivers who will furnish the care and the frequency of the visits ...." 2. A home visit of patient #1 was observed on 2/11/2021 at 10:00 AM, start of care date 4/7/2020, and primary diagnosis of encounter for attention to cystostomy (suprapubic catheter - an opening in the lower abdomen where a tube is inserted directly into the bladder for urine drainage). The patient received skilled nursing services. Agency staff, patient and family were unable to locate the patient's home folder. The patient indicated he knew when staff was coming by when they called him the night before, and he didn't have a schedule. 3. A home visit of patient #5 was observed on 2/23/2021 at 12:30 PM, start of care date 1/26/2021, and primary diagnosis of hypertensive heart disease with heart failure (a heart condition caused by high blood pressure). The patient's home folder failed to evidence a written visit schedule. The patient received skilled nursing and physical therapy services. 4. A home visit of patient #6 was observed on 2/23/2021 at 10:00 AM, start of care date 1/31/2021, and primary diagnosis of cellulitis (an infection of the skin and deep underlying tissues) of left lower limb. The patient received skilled nursing services. The patient's home folder failed to evidence a written visit schedule. 5. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of COVID-19. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021 . The patient's home folder failed to evidence a written visit schedule. When asked if he knew when agency staff was scheduled to visit, the patient stated "... Yeah, whenever they feel like coming ...." He indicated he didn't like that he never knew when the physical therapist was going to come, and stated "... he switched his schedule and never showed ...." He also indicated he thought a nurse was supposed to be coming since he got home from the hospital, and stated "... [he] finally saw a nurse last week [week of 2/14/2021] for the first time." 6. A home visit of patient #13 was observed on 2/25/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of displ intertroch fx L femur, subs for clos fx w routn heal (left hip fracture which required surgical intervention). The patient received physical and occupational therapy services, skilled nursing and home health aide services were ordered on 2/22/2021. The patient's home folder failed to evidence a written visit schedule.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure that all patients had current/updated written medication schedule/instructions prepared by agency staff in the home for 5 of 7 home visits observed (#1, 5, 6, 7, 13,). Findings include: 1. Review of an agency policy approval/review date 4/2020 titled "2.1 Patient Rights and Responsibilities" stated "... the patient is informed both verbally and in writing of all rights including: ... treatment [i.e. medications] or services...." 2. A home visit of patient #1 was observed on 2/11/2021 at 10:00 AM, start of care date 4/7/2020, and primary diagnosis of encounter for attention to cystostomy (suprapubic catheter - an opening in the lower abdomen where a tube is inserted directly into the bladder for urine drainage). The patient received skilled nursing services. Agency staff, patient and family unable to locate the patient's home folder. The patient indicated he didn't know what medications he took. There failed to be evidence of a medication schedule provided by the home health agency in the patient's home. Record review for patient #1 that was completed on 2/1/2021, evidenced a document dated 1/7/2021, titled "Client Coordination Note Report", which stated "... Medication reconciliation not done today as daughter was not in home and patient doesn't [sic] k ow [sic] where list or meds are ...." 3. A home visit of patient #5 was observed on 2/23/2021 at 12:30 PM, start of care date 1/26/2021, and primary diagnosis of hypertensive heart disease with heart failure (a heart condition caused by high blood pressure). The patient received skilled nursing and physical therapy services. The patient's home folder failed to evidence a medication schedule/instructions prepared by agency staff. The patient indicated she used the list the hospital gave her upon discharge for reference. 4. A home visit of patient #6 was observed on 2/23/2021 at 10:00 AM, start of care date 1/31/2021, and primary diagnosis of cellulitis (an infection of the skin and deep underlying tissues) of left lower limb. The patient received skilled nursing services. The patient's home folder failed to evidence a medication schedule/instructions prepared by agency staff. 5. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of COVID-19. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021 . The patient's home folder failed to evidence a medication schedule/instructions prepared by agency staff. 6. A home visit of patient #13 was observed on 2/25/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of displ intertroch fx L femur, subs for clos fx w routn heal (left hip fracture which required surgical intervention). The patient received physical and occupational therapy services, skilled nursing and home health aide services were ordered on 2/22/2021. The patient's home folder failed to evidence a medication schedule/instructions prepared by agency staff.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure that all patients received a current/updated written plan of care for 5 of 7 home visits observed (#1, 5, 6, 7, 13,). The findings include: 1. Review of an agency policy, with an approval/review date of 4/2020, titled "2.1 Patient Rights and Responsibilities" stated "... the patient is informed both verbally and in writing of all rights including: ... the right to participate in planning care or treatment and in planning changes ... update the patient, representative caregivers ... when a change is being made ...." 2. Review of an agency policy, with an approval/review date of 4/2020, titled "Care Management and the Plan of Care" stated "... The clinician works closely with the client/caregiver, who participates in development and carrying out the plan of care and changes to the plan of care ...." 3. A home visit of patient #1 was observed on 2/11/2021 at 10:00 AM, start of care date 4/7/2020, and primary diagnosis of encounter for attention to cystostomy (suprapubic catheter - an opening in the lower abdomen where a tube is inserted directly into the bladder for urine drainage). The patient received skilled nursing services. Agency staff, patient and family were unable to locate the patient's home folder. The patient failed to have written information provided by the home health agency of any treatments they were to administer 4. A home visit of patient #5 was observed on 2/23/2021 at 12:30 PM, start of care date 1/26/2021, and primary diagnosis of hypertensive heart disease with heart failure (a heart condition caused by high blood pressure). The patient received skilled nursing and physical therapy services. The patient's home folder failed to evidence a current/updated plan of care which would include any treatments the agency was to administer. 5. A home visit of patient #6 was observed on 2/23/2021 at 10:00 AM, start of care date 1/31/2021, and primary diagnosis of cellulitis (an infection of the skin and deep underlying tissues) of left lower limb. The patient received skilled nursing services. The patient's home folder failed to evidence a a current/updated plan of care which would include any treatments the home health agency was to administer. 6. A home visit of patient #7 was observed on 2/23/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of COVID-19. The patient received physical and occupational therapy services, and skilled nursing services was ordered on 2/18/2021 . The patient's home folder failed to evidence a current/updated plan of care, which would include any treatments the home health agency was to administer. . 7. A home visit of patient #13 was observed on 2/25/2021 at 1:50 PM , start of care date 1/22/2021, and primary diagnosis of displ intertroch fx L femur, subs for clos fx w routn heal (left hip fracture which required surgical intervention). The patient received physical and occupational therapy services, and skilled nursing and home health aide services were ordered on 2/22/2021. The patient's home folder failed to evidence a a current/updated plan of care, which would include any treatments the home health agency was to administer. 8. During an interview on 2/12/2021 at 4:48 PM, OT [occupational therapist] F indicated the plans of care were mailed to the patients. 9. During an interview on 2/12/2021 at 5:41 PM, RN [registered nurse] G indicated he didn't know if a current/updated copy of the plan of care was in the patients' home folders. 10. During an interview on 3/2/2021 at 2:30 PM, the administrator indicated there was no proof the patients received their mailed plans of care, and agreed they were not evidenced in the home folders observed during home visits.

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 skilled nurse failed to follow standard precautions (a group of infection practices that apply to all patients regardless of suspected or confirmed infection status at the time health care is delivered, and are based on the principle that all blood, body fluids, secretions, excretions, may contain transmissible infectious agents) for 1 of 3 home visits observed with patients who required wound care. (#1) The findings include: 1. Review of an undated agency policy titled "Hand Hygiene" stated "... To prevent transfer of germs and transmission of infections to patients and caregivers ... Indications for staff performing hand hygiene are: ... Before and after each procedure ... After contact with any contaminated materials ... Before [accessing] patient's clean supplies ... All employees are responsible for implementing hand hygiene procedures ... {hand hygiene] After removing gloves ... After contact with blood, body fluids, ... non-intact skin and wound dressings ... Moving from contaminated patient body site to clean site during patient care ...." 2. Review of a reference CDC (Centers for Disease Control and Prevention) web-based site (https://www.cdc.gov/hai/ca_uti/uti.html) titled "Catheter-associated Urinary Tract Infections (CAUTI)" stated "... A urinary tract infection (UTI) ... is ... the most common type of healthcare-associated infection ...." 3. A home visit of patient #1 was observed on 2/11/2021 at 10:00 AM, start of care date 4/7/2020, and primary diagnosis of encounter for attention to cystostomy (suprapubic catheter - an opening in the lower abdomen where a tube is inserted directly into the bladder for urine drainage). LPN [licensed practical nurse] HH removed a soiled dressing from the patient's right buttock, and performed wound care. After wound care was completed, LPN HH failed to remove his contaminated gloves, perform hand hygiene, and don new gloves before moving to the patient's suprapubic catheter site (to perform a dressing change and care of the site. The clinical manager was present during the home visit and indicated standard precautions were not followed.

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 record review and interview, the agency failed to ensure the responsibilities of the governing body, administrator and clinical manager were not delegated to another organization or other person(s) on an on-going basis (See G942); the administrator failed to be appointed by and reported directly to the Governing Body (See G946); the administrator failed to be responsible for the day to day functions of the agency (See G948); the clinical manager failed ensure coordination of referrals (See G964); failed to maintain overall responsibility for the services it provided under arrangement, and failed to maintain overall responsibility for the manner in which they were furnished; and failed to maintain overall responsibility for the services it provided (G978). Additionally: 1. IDOH [Indiana Department Of Health] has no reciprocal agreements with surrounding states for the home health program. 2. Review of an agency document for scheduled home visits on 2/12/2021 titled "Worker Schedule Report" evidenced agency staff was scheduled to see patients in Michigan, and stated "... Assigned Branch: MIH [Saint Joseph VNA] ... Assigned Branch MUH [Muskegon, Michigan- home care agency D] ...." 3. Review of an IDOH document titled "Facility Census-Home Health" stated "... Skilled Patients ... MIH 229 + MUH 16 ... Total 245 ... Total # [number] of active patients ... MIH 229 + MUH 16." 4. During an interview on 2/9/2021 at 1:42 PM, the administrator stated "We see patients in Michigan. They're our patients ... 'MIH' is Mishawaka, and 'MUH' is Muskegon." She indicated MUH was not a branch of the agency, and both agencies were owned by corporation E. 5. During an interview on 2/9/2021 at 11:05 AM, the administrator/clinical manager indicated the agency saw patients in Michigan, and stated "... It's our staff, our patients. Our clinicians have both state's licenses." 6. During an interview on 2/9/2021 at 2:10 PM, the administrator indicated she was told by the colleague relations partner (Human Resource-HR) the agency was contracted with home care agency D, and as requested by the surveyor, she indicated she would submit a copy of the contract. 7. During an interview on 2/9/2021 at 2:17 PM, the surveyor received an admission packet from administrative assistant W (with home care agency D's information), who indicated it was the admission packet agency clinicians provided to Michigan patients. 8. During an interview on 2/9/2021 at 2:57 PM, the colleague relations partner, person C (St. Joseph VNA Home Care's human resource employee) indicated St. Joseph VNA Home Care had no contracts on premises, it had no access, and any contracts were "... up at corporate." 9. During an interview on 2/9/2021 at 3:34 PM, colleague relations partner, person C indicated she spoke with the executive director over home care agency D, and stated "Because we're both under [corporation E], our parent company, it's just considered just a transfer of labor between the agencies, and our clinicians seeing patients also have Michigan licenses. [Person H] was the former compliance officer with 'corporate', and she was involved with both states to make sure it was all okay, and that's why 50% [of our staff] have dual licenses prior to implementing [services to Michigan patients] in 2018, [because] that's what state wanted." 10. During an interview on 2/9/2021 at 2:49 PM, the administrator stated "... They [home care agency D] pay us for the [agency staffing] labor." When asked if there was a written contract, she stated "... not needed because we are same organization per [colleague relations partner, person C]." She also indicated home care agency D's patients were included in the agency's quality assurance/performance improvement (QAPI) program. When queried if home care agency D asked about the Michigan patients, she stated "No." When queried how the agency handled complaints made by Michigan patients, she indicated the agency gave the Michigan Board of Health contact information. When queried if a Michigan surveyor showed up at home care agency D, and visited one of the patients St. Joseph VNA Home Care staff cared for in Michigan, would it be correct to say home care agency D wouldn't know anything about the patient, colleague relations partner stated "Correct." Also, she indicated agency staff who saw patients in Michigan were not dually employed by home care agency D St. Joseph VNA Home Care. When queried how the agency ensured staff followed Michigan regulations, she stated "That is a good question." 11. During an interview on 2/12/2021 at 4:48 PM, OT F indicated she saw patients in Michigan for at least two years, agency (Saint Joseph VNA) staff admitted the patients, if patients had a complaint or needed to speak with a clinician, home care agency D patients called St. Joseph VNA Home Care cell numbers, and stated "We give them our name and number they can call, but the [home] folder has [home care agency D] numbers." She also indicated she never had an on-site supervisory visit (in Michigan) to evaluate her performance or to evaluate the patients' satisfaction with home care agency D patients, she reported to PT [physical therapist] A, case conferences were conducted with agency staff, home care agency D's office was located in Muskegon, she hadn't spoken with anyone at home care agency D for over two years, and the patients' home folders were specific to the state they lived in. 12. During an interview on 2/12/2021 at 5:41 PM, RN G indicated he saw patients in Michigan for "... probably not quite a year ....", agency staff with Michigan nursing licenses admitted the patients, if patients had a complaint or needed to speak with a clinician, home care agency D patients would call the toll free (corporate) number. He also indicated he never had an on-site supervisory visit (for Michigan patients he provided services to) to evaluate his performance or to evaluate the patients' satisfaction with home care agency D patients, he reported to RN (Clinical Manager) D, and case conferences were conducted with agency staff every morning via Zoom conference. He stated "Our main office is Livonia [Michigan]. There could very well be another satellite, not sure. Calls go through [agency] office." 13. During an interview on 2/26/2021 at 2:26 PM, person J (Corporate CEO [chief executive officer], President, Governing Body Member) indicated the agency does provide staff for home care agency D patients, the staff were dually licensed in both states, and that made them eligible to see home care agency D's patients. The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR 484.105 Organization and administration of services. 17-12-1(a)(1) 17-12-1(a)(2) 17-12-1(b) 17-12-1(b)(1) 17-12-1(b)(3) 17-12-1(c)(1) 17-12-2(d) 17-12-2(e)

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the governing body failed to ensure the agency's overall management and oversight was not delegated to another person or organization, agency lines of authority for the delegation of responsibility were clearly identifiable and readily available, and provision of home health services was only provided for patients in the state of Indiana under the agency's license issued by IDOH [Indiana Department of Health]. The findings include: 1. Review of an agency policy with an approval/revised date of 02/2019, titled "Governance: Home Health Board of Directors" stated "The Homecare Board of Directors is the Governing Body with full responsibility for THAH [Trinity Health at Home, corporate owner of agency] agencies ... Appointment of a qualified CEO [chief executive officer], Homecare Director/Administrator and alternate for each agency, delegating to that individual, the responsibility for the quality of services provided by that Agency ... Communication directly with the agency Administrator/Director as needed ...Meeting quarterly and, as necessary, recording minutes in which all decisions regarding home healthcare are documented ... An administrator or director has direct access to the board with no intermediaries." 2. Review of an undated agency document received on 2/11/2021, titled "Trinity Health at Home (THAH) Board of Directors" evidenced person J as the CEO [chief executive officer], President, GB [governing body] Member, and failed to evidence person G (VP [vice president] Operational Excellence/Regional Executive Director) or person I (COO- Chief Operating Officer) as members of the governing board for Saint Joseph VNA Home Care located in Indiana. 3. Review of an agency document received on 2/9/2021, titled "Saint Joseph VNA Home Care Colleague List" failed to evidence person G or person I were agency employees. 4. Review of an agency document received on 2/09/2021, titled "Saint Joseph VNA Home Care Organizational Chart" evidenced the administrator reported to the governing body and person G. 5. Review of another agency document received on 2/10/2021, titled "Saint Joseph VNA Home Care Organizational Chart" evidenced the administrator reported directly to person G, who reported to person I, who reported to person J. These persons the administrator reported to failed to be evidenced as a governing body member, owner or officer of the agency located in Indiana. 6. Review of an agency job description dated 10/01/2018, titled Administrator, Regional Administrator indicated the administrator reports to the Executive Director/Regional Executive Director, not the governing body. 7. During an interview on 2/26/2021 at 2:26 PM, person J of the governing body indicated the agency does staff Michigan patients, the staff were dually licensed in both states, and that made them eligible to see Michigan patients. 17-12-1(b)

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be appointed by and reported directly to the Governing Body (GB). The findings include: Review of an agency policy with an approval/revised date of 02/2019, titled "Governance: Home Health Board of Directors" stated "The Homecare Board of Directors is the Governing Body with full responsibility for THAH [Trinity Health at Home, corporate owner of agency] agencies ... Appointment of a qualified CEO [chief executive officer], Homecare Director/Administrator and alternate for each agency, delegating to that individual, the responsibility for the quality of services provided by that Agency ... Communication directly with the agency Administrator/Director as needed ...Meeting quarterly and, as necessary, recording minutes in which all decisions regarding home healthcare are documented ... An administrator or director has direct access to the board with no intermediaries." Review of an undated agency document received on 2/09/2021, titled "Saint Joseph VNA Home Care Organizational Chart" evidenced the administrator reported to the governing body and person G. Review of another agency document dated 2/8/2021, received on 2/10/2021, titled "Saint Joseph VNA Home Care Organizational Chart" evidenced the administrator reported directly to person G (VP [vice president] Operational Excellence/Regional Executive Director), who failed to be evidenced as a governing board member or officer of the agency at the Indiana Department of Health. Review of an undated agency document received on 2/11/2021, titled "Trinity Health at Home (THAH) Board of Directors" evidenced person J as the CEO, President, GB Member, and failed to evidence person G as a member of the GB/Board of Directors. Review of an agency document received on 2/9/2021, titled "Saint Joseph VNA Home Care Colleague List" failed to evidence person G was an agency employee. Review of an agency job description dated 10/1/2018, titled "Administrator (Agency Administrator, Regional Administrator)" evidenced the administrator reported to person G (not the governing body). Review of an unsigned document dated 12/2/2020, titled "Trinity Continuing Care Board of Directors Meeting" stated "Consent Agenda ... Recommendations for Appointment of Alternate Administrators ... It is requested that this Board of Directors appoint [interim administrator D] as the alternate administrator ...." The document failed to evidence who the request was made by, or the request was approved by the governing body. During an interview on 2/10/2021 at 2:49 PM, the administrator indicated she reported to person G (not the governing body), and she didn't know who the members of the governing body were. During an interview on 2/25/2021 at 3:00 PM, the administrator indicated she was initially hired by the VP Operational Excellence/Regional Executive Director (person G) on 7/27/2020 as the interim administrator and clinical manager. She indicated the agency's former administrator did her initial interview, but person G made the final decision and hired the agency's administrator and clinical manager(s). Additionally, she accepted role as the agency administrator on or about 2/17/2021. During this time, meeting minutes were requested that evidenced governing body appointment and approval of her role as interim administrator and subsequently full time administrator. No additional documentation was submitted upon survey exit. 17-12-1(b)(1)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for the day to day functions of the agency. The findings include: 1. Review of an agency policy with an approval/revised date of 02/2019, titled "Governance: Home Health Board of Directors" stated "The Homecare Board of Directors is the Governing Body with full responsibility for THAH [Trinity Health at Home, corporate owner of agency] agencies ... Appointment of a qualified CEO [chief executive officer], Homecare Director/Administrator and alternate for each agency, delegating to that individual, the responsibility for the quality of services provided by that Agency ...." 2. Review of an agency document dated 2/8/2021, received on 2/10/2021, titled "Saint Joseph VNA Home Care Organizational Chart" evidenced the administrator reported directly to person G (VP Operational Excellence/Regional Executive Director). 3. Review of an agency document received on 2/9/2021, titled "Saint Joseph VNA Home Care Colleague List" failed to evidence person G was an agency employee of Saint Joseph VNA Home Care. 4. Review of an agency job description dated 10/1/2018, titled "Administrator (Agency Administrator, Regional Administrator)" evidenced the administrator reported to the Executive Director/Regional Executive Director (not the governing body), and stated "... Directs the homecare/hospice agency ongoing functions in compliance with policy and legal requirements including maintenance of appropriate records, supervision of office personnel ... Hires, orients, and leads qualified management and administrative personnel ... Responsible for implementing Regional Executive Director directives ...." 5. Review of an agency job description dated 1/2017, titled "Clinical Manager" stated "...Reports to: Executive Director ...." The job description failed to evidence the clinical manager reported to the administrator. 6. During an interview on 2/9/2021 at 1:23 PM, the administrator indicated she had no control over authorizing the surveyor access to the agency's electronic health records (EHR), it was controlled and authorized by "corporate", company policies had to be released by corporate person L (Regional Compliance, Survey Accreditation Manager), she had no control over the decision that the agency saw Michigan patients (decision was made by corporate), 7. During an interview on 2/9/2021 at 2:57 PM, the administrator stated "... Corporate makes final say on all management hires." During this time, the Colleague Relations Partner (agency human resource person) indicated no contracts were located at the agency, they were at corporate level, the agency had no access to them, and access had to be requested. 8. During an interview on 2/10/2021 at 2:49 PM, the administrator indicated corporate had the final decision who was hired for agency management positions. 9. During an interview on 2/22/2021 at 11:47 AM, the administrator indicated the agency kept no hard copies of personnel files on site at the agency, they were maintained at the corporate location in Michigan, and she was going to follow up with corporate to find out how the surveyor could get full access to the personnel records. 10. During an interview on 2/22/2021 at 12:09 PM, Colleague Relations Partner, person C indicated she followed up with the corporate Senior Accreditation Manager (not an agency employee), who was concerned about releasing/printing entire personnel record, she wanted to know what regulation required this, indicated the surveyor could look at the electronic files with the assistance of the Colleague Relations Partner, but she would not allow any part of the personnel records to be printed without proof of need. 11. During an interview on 3/2/2021 at 10:24 AM, Colleague Relations Partner, person C indicated she reported to the (corporate) Colleague and Labor Relations Manager (not the administrator). 17-12-1(b)(3) 17-12-1( c)(1)

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to coordinate agency referrals. The findings include: Review of an undated agency policy titled " Care Management and the Plan of Care" stated "... The nurse/therapist assigned to admit the client: ... Within 1 day of the referral, calls the prospective patient to discuss needs ...." Review of an undated agency policy titled "Physician Orders" stated "... Orders to initiate billable insurance services: ... a telephone referral from the physician office for home care evaluation is taken by an office representative who enters a referral information note ... A faxed referral that is not signed by the physician is sufficient to make the first visit if it contains an indication written by the home care coordinator/discharge planner ...." During an interview on 2/9/2021 at 11:05 AM, the administrator indicated hospital referrals were faxed to corporate intake for processing, not the agency, then the agency received the referral if it was approved by corporate.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to maintain overall responsibility for the services it provided under arrangement with home care agency D (a home care agency in Muskegon, Michigan with same corporate ownership as agency), and failed to maintain overall responsibility for the manner in which they were furnished. The findings include: IDOH [Indiana Department of Health] has no reciprocal agreements with surrounding states for the home health program. Review of an agency document for scheduled home visits on 2/12/2021, titled "Worker Schedule Report" evidenced agency staff was scheduled to see patients for home care agency D, and stated "... Assigned Branch: MIH [Saint Joseph VNA] ... Assigned Branch MUH [home care agency D] ...." Record review failed to evidence any written agreement between Saint Joseph VNA Home Care and agency D. During an interview on 2/9/2021 at 11:05 AM, the administrator/clinical manager indicated the agency saw patients in Michigan, and stated "... It's our staff, our patients. Our clinicians have both state's licenses." During an interview on 2/9/2021 at 2:10 PM, the administrator indicated she was told by the colleague relations partner, person C (Human Resource-HR) the agency was contracted with home care agency D, and as requested by the surveyor, she indicated she would submit a copy of the contract. During an interview on 2/9/2021 at 2:57 PM, the colleague relations partner, person C indicated the agency had no contracts on premises, the agency had no access, and any contracts were "... up at corporate." During an interview on 2/9/2021 at 2:49 PM, the administrator stated "... They [home care agency D] pay us for the [agency staffing] labor." When asked if there was a written contract, she stated "... not needed because we are same organization per [colleague relations partner, person C]." During an interview on 2/26/2021 at 2:26 PM, person J (Corporate CEO, President, Governing Body Member) indicated the agency did staff home care agency D's patients, the staff were dually licensed in both states, and that made them eligible to see those patients. 17-12-2(d)