Every finding on record at Bmo Home Health Care Inc

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 operations of the agency. The findings include: The administrator failed to ensure the day-to-day operations of the home health agency as evidenced by: The administrator failed to ensure the agency policy was followed for the review of medications. Please see tag G0536. The administrator failed to ensure the services provided followed the plan of care for agency patients. Please see tag G0572. The administrator failed to ensure the plan of care contained all required elements. Please see tag G0574. The administrator failed to ensure the primary care physician was promptly alerted to changes in the patient’s condition. Please see tag G0590. The administrator failed to ensure there was coordination of care amongst other entities servicing agency patients. Please see tag G0606. The administrator failed to ensure all home health aide care plans were complete and individualized. Please see tag G0798. The administrator failed to ensure all services were provided by the home health aide as directed in the aide care plan. Please see tag G0800. The administrator failed to ensure the supervising nurse ensured the home health aide followed the aide care plan. Please see tag G0818. The administrator failed to ensure the clinical manager provided oversight in coordinating patient referrals. (See tag G0964). The administrator failed to ensure all clinical records contained all required documentation of services rendered by agency staff. Please see tag G1012. The administrator failed to ensure all clinical notes were appropriately authenticated. Please see tag G1024. During an interview on 11/2/2022, at 12:36 PM, the administrator indicated she was not aware of a physical therapy referral for Patient #2. At 12:48 PM, the administrator indicated she was responsible for agency’s plan of correction and indicated she was not aware of some of the issues before now. 410 IAC 17-12-(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 manger failed to provide oversight of coordinating referrals. The findings include: Clinical record review on 10/28/2022, for Patient #2, start of care 6/11/2019, evidenced a document from the physician responsible for the plan of care titled “Tele [telehealth] Visit Progress Note” dated 7/18/2022. Review indicated the physician’s current orders included, but were not limited to, referral to physical therapy. Review failed to evidence physical therapy services were provided. During an interview on 10/31/2022, at 12:02 PM, the clinical manager indicated she was not aware of a referral for physical therapy.

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 home health aide failed to prepare clinical notes to include the clinician’s title in 1of 2 clinical records reviewed receiving home health aide services. (#1) The findings include: Review of an undated agency policy obtained 11/2/2022, titled “Clinical Record Content/Medical Record Retention” stated, “… The individual must … sign the entry, complete with his or her title to authenticate an entry in the clinical record….” Clinical record review on 11/2/2022, for Patient #1, start of care 6/3/2019, evidenced agency documents titled “Medicaid” and identified by the clinical manager as home health aide (HHA) visit notes, signed and dated by HHA #1 on 10/24/2022, 10/25/2022, 10/27/2022, and 10/28/2022. These home health aide visit notes failed to evidence the clinician’s credentials. During an interview on 11/2/2022, at 12:57 PM, the administrator indicated the HHA should include her title. 410 IAC 17-15-1(a)(7)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patient’s medication was reviewed to identify any potential adverse effects and drug reactions in 2 of 2 clinical records reviewed. (#1, 2) The findings include: 1. Review on 9/16/2022 of an undated agency policy titled “Comprehensive Assessment of Patients” stated, “… A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions … Any medication prescribed or over the counter … should be included on the medication list….” 2. Clinical record review on 9/13/2022, for Patient #1, start of care 6/3/2019, evidenced an agency document titled “Verbal Order” signed and dated by the clinical manager on 8/16/2022. Review indicated the patient had been prescribed new medications azithromycin (an antibiotic to treat infection) and budesonide (an inhaled medication used to treat inflammation in the lungs). Review failed to evidence a medication list since 8/5/2022 which included the medication review for azithromycin and budesonide During an interview on 9/14/2022, at 12:46 PM, the clinical manager indicated the medication review was completed when the medication was entered on the medication profile and the computer program runs a medication review to include potential drug interactions. The clinical manager indicated there was not a medication profile with a medication review of azithromycin and budesonide prior to 9/14/2022. 3. Clinical record review on 9/13/2022, for Patient #2, start of care 6/11/2019, evidenced a document from the physician responsible for the plan of care titled “Tele Visit Progress Note” dated 7/18/2022. Review indicated the physician’s current orders included, but were not limited to, Vilazodone (a medication used to treat depression) and Flonase (an inhaled medication used to treat allergies). Review failed to evidence the medications were included on the medication profile and were reviewed for potential drug interactions. During an interview on 9/14/2022, at 1:09 PM, the clinical manager indicated the medications must have been left off the medication profile. 410 IAC 17-14-1(a)(1)(B)

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure all orders were recorded in the plan of care in 1 of 1 clinical record reviewed with wounds. (#1) The findings include: Review on 9/16/2022 of an undated agency policy titled “Plan of Care (485)” stated, “… All patient care orders, including verbal orders, must be included in the plan of care….” During an observation of care at the home of Patient #1, start of care 6/3/2019, on 9/14/2022, at 9:46 AM, the patient was observed to have a tube inserted into her abdomen. The clinical manager was observed pouring water into a large syringe inserted into the tube inserted into the patient’s abdomen. The clinical manager was observed cleaning the site around the tube inserted into the abdomen and applying a clean dressing around the insertion site. Clinical record review on 9/13/2022 evidenced an agency document titled “Verbal Order” and dated 7/1/2022. Review indicated the plan of care was to include orders for the skilled nurse to administer medications, provide stoma (opening in the body) care for the gastrostomy tube (a surgically inserted tube into the stomach through the abdomen to deliver nutrition, fluid, and/or medication), administer gastrostomy flushes, and perform a head-to-toe assessment. Review evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 7/17/2022 – 9/14/2022. Review failed to evidence the plan of care included the orders for the skilled nurse to administer medications, administer the gastrostomy flushes, provide gastrostomy site care, and perform a head-to-toe assessment. During an interview on 9/14/2022, at 12:10 PM, the administrator indicated the orders to be added to the plan of care obtained on 7/1/2022 must have been left off the plan of care but should have been included.

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Facility ID: 009945 Survey dates: 6/29/2022 – 7/8/2022 At this Emergency Preparedness survey, BMO Home Health Care, Inc., was found not to be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to develop and implement individualized emergency preparedness plans for the patients which provided appropriate instructions, in the event of an emergency in 2 of 2 home visits. (#1, 2) The findings include: 1. During an observation of care for patient #1, start of care 6/3/2019, on 6/30/2022, at 10:03 AM, the agency folder was observed in the patient’s bedroom. The patient’s individualized emergency preparedness plan was not observed in the agency folder or in the patient’s home. Clinical record review on 6/29/2022, evidenced an agency document titled “Nursing Visit Record”, signed by the registered nurse and dated 6/7/2022. This document was identified to be the resumption comprehensive assessment. The patient was assessed to have wounds to the sacrum (area to the lower back above the buttocks) and right great toe and was assessed to have a peg tube (a plastic tube surgically inserted into the stomach through the abdomen to provide fluid, nutrition, and/or medications) which was used to provide tube feeding. Review of an agency document titled “Emergency Care Plan” dated 6/3/2019, failed to indicate the evacuation location, wound care and peg tube supplies, required by the patient in the event of an emergency. 2. During an observation of care at the home of patient #2, start of care 6/11/2022, on 6/29/2022, at 5:40 PM, the agency folder was observed in the patient’s bedroom. The patient’s individualized emergency preparedness plan was not observed in the agency folder or in the patient’s home. The patient was observed to have a amputation of both legs and was sitting in a motorized wheelchair. Clinical record review on 6/29/2022, evidenced an agency document titled “Emergency Care Plan” dated 6/3/2019, which failed to indicate the evacuation location. 3. During an interview on 7/1/2022, at 1:01 PM, the clinical manager indicated the agency does individualize the patient’s emergency preparedness plans and indicated they should. 4. During an interview on 7/1/2022, at 3:43 PM, the administrator indicated there should be an individualized emergency preparedness plan in each patient’s home and the agency should discuss what is each patient’s emergency evacuation plan to include the evacuation location.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included contact information for Federal and State emergency preparedness staff. The findings include: Review of an undated agency policy obtained on 7/6/2022, titled “Emergency Preparedness Communication Plan” stated, “… Contact information for the following: Federal, State … emergency preparedness staff ….” Review of the agency’s emergency preparedness communication plan on 7/6/2022 failed to evidence the contact information for Federal and State emergency preparedness staff. During an interview on 7/6/2022, at 3:55 PM, the administrator indicated she did not see the contact information for the Federal and State emergency preparedness staff.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct exercises to test the emergency preparedness plan at least annually. The findings include: Review of an undated agency policy obtained 7/6/2022, titled “Emergency Preparedness Training and Testing” stated, “… BMO must conduct exercises to test the emergency plan at least annually. BMO will do the following: Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If BMO cannot participate in a full-scale exercise; it must show documentation why the agency could not participate in a full-scale exercise….” Review of the agency’s emergency preparedness plan on 7/6/2022, evidenced a tabletop exercise in 2019 and 2020. Review failed to evidence testing was provided during 2020 and failed to evidence a community-based exercise. During an interview on 7/6/2022, at 3:55 PM, the administrator indicated she did not see any testing for the emergency preparedness plan in 2020 and did not see a community-based exercise.

This survey was a Re-certification and Emergency Preparedness survey for a home health agency. Survey Dates: 6/29/2021 – 7/8/2022 Facility ID: IN009945 An Immediate Jeopardy related to §484.55 Comprehensive Assessment and §484.60 Care Planning, Coordination of Services, and Quality of Care was identified and announced on 7/6/2022 at 10:47 AM. The Immediate Jeopardy was removed before exit on 7/8/2022, at 12:47 PM. Potential additional findings to follow. The clinical manager completed a comprehensive assessment for patient #1 on 7/7/2022 to include an assessment of the sacrum and 2 wounds on the right great toe. The clinical manager contacted the wound clinic at hospital #1 to coordinate care regarding the wounds, and the clinical manager contacted the physician for patient #1 to inform the physician of the wounds and wound orders per the wound clinic. The administrator had contacted the caregiver for patient #1 and informed her of wound orders and to inform her the clinical manager would provide wound care 3 times a week per orders. The clinical manager contacted the physician for patient #2 to obtain a referral for social work services, and the physician did not agree to give the order until the patient is seen at the physician’s office. The caregiver for patient #2 was informed of the need for the patient to be seen by the physician. All home health aides were inserviced to report any changes in patient condition to the clinical manager. Due to the actions taken by the agency, the Immediate Jeopardy was removed prior to the conclusion of the survey on 7/8/2022, at 12:47 PM. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. BMO Home Health Care, Inc. is precluded from providing its own home health aide training and competency evaluation for a period of two years which began on 07/08/2022 – 07/08/2024, due to being found out of compliance with Conditions of Participation 42 CFR 484.45 Reporting OASIS information, 484.55 Comprehensive Assessment of Patients and 484.60 Care Planning, Coordination of Care and Quality of Care. Quality Review Completed 07/26/2022

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to electronically report and transmit an OASIS (Outcome and Assessment Information Set) assessment in 1 of 1 clinical record reviewed receiving skilled nursing services. (#1) The findings include: Review of iQIES on 6/30/2022 failed to evidence OASIS submissions for the agency. Clinical record review for patient #1, start of care 6/3/2019, evidenced an agency document titled “Assessment Details” completed by the registered nurse and dated 5/18/2022, which was indicated to be a recertification assessment. Review indicated the patient was to receive home health aide services and respite skilled nursing services. Review failed to evidence the assessment data was electronically reported and transmitted to the CMS (Centers for Medicare and Medicaid Services) system. Review of an agency document titled “Assessment Details” completed by the registered nurse and dated 6/7/2022, indicated the document was a resumption of care assessment after the patient was transferred to the hospital on 5/24/2022 and then had an inpatient stay at a skilled nursing facility. Review indicated the patient was to receive home health aide services and respite skilled nursing services. Review failed to evidence the assessment data was electronically reported and transmitted to the CMS (Centers for Medicare and Medicaid Services) system. During an interview on 7/6/2022, at 10:27 AM, the administrator indicated the agency had not been submitting OASIS information because they did not know they needed to for patients receiving respite nursing services. The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.45 Reporting OASIS information.

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: An Immediate Jeopardy related to §484.55 Comprehensive Assessment of Patients was identified and announced on 7/6/2021 at 10:47 AM. The Immediate Jeopardy began on 6/7/2022 when the agency resumed care for patient #1 after a hospitalization on 5/24/2022 and followed by an admission at a skilled nursing facility. An order to resume care was obtained on 6/7/2022, and the registered nurse assessed the patient to have a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the sacrum (lower back above the buttocks) and a diabetic wound to the right great toe. The registered nurse failed to include in the comprehensive assessment the size and description of the sacral wound. The registered nurse failed to include in the comprehensive assessment the patient’s goals and measurable outcomes related to the patient’s wounds. The skilled nurse on 6/8/2022 noted a wound to the sacrum and a wound to the right great toe. No additional skilled nurse visits were provided. During a home visit on 6/30/2022 for observation of care with the home health aide, the patient was observed to have 1 wound to the sacrum and 3 wounds to the right great toe. The agency failed to ensure the comprehensive assessment was updated to include the assessment of the 2 additional wounds to the right great toe. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients. Other unrelated conditions of participation and findings will be cited. A standard deficiency was also cited as follows: Based on observation, record review and interview, the home health agency failed to provide a patient-specific, comprehensive assessment, failed to include the assessment of the patient’s goals and measurable outcomes related to wounds in the comprehensive assessment, and failed to update the comprehensive assessment with a change in patient’s status regarding the additional wounds in 1 of 1 home visits conducted with a patient with wounds (#1). This practice has the potential to affect all patients with wounds. The findings include: Review of an undated agency policy obtained on 7/6/2022, titled “Comprehensive Assessment of Patients (Admission Policy)” stated, “… Each patient must receive, and BMO Home Health Care, Inc., must provide, a patient-specific comprehensive assessment. … The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: The patient’s current health status, psychosocial, functional, and cognitive status … Patient’s strengths, goals and care preferences, including the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by BMO Home Health Care, Inc. … The Comprehensive Assessment must be updated and revised … as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status ….” Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Home Health Plan of Care and Certification” for certification period 5/18/2022 – 7/16/2022. Review indicated the agency was to provide home health aide services 10 hours a day, 7 days a week and respite skilled nursing services 96 hours per month at caregiver’s request. Review of an agency document titled “Verbal Order” dated 5/25/2022, indicated the patient was admitted to the hospital on 5/24/2022, and agency services were on hold. Review of an agency document titled “Nursing Visit Record” signed by the registered nurse and dated 6/7/2022, and administration identified the document as the resumption of care comprehensive assessment. Review evidenced the patient had a wound to the sacrum and a wound to the right great toe. Review indicated the wound to the right great toe was red in color and failed to evidence the assessment of the sacral wound included the wound size and description. Review of an agency document titled “Assessment Details” dated 6/7/2022, indicated the document was for a resumption of care comprehensive assessment. Review indicated the nurse noted the patient had wounds and failed to evidence the assessment included patient goals and measurable outcomes related to the patient’s wounds. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the patient was observed to have a clear dressing to the sacrum and was observed to have a black area to the top area of the right great toe that continued down the medial (area towards the middle of the body) side of the right great toe with edges pulling away from the surrounding skin. The patient was observed to have a black area to the back side of the right great toe the size of the pinky fingernail and observed to have an open area to the lateral (area away from the middle of the body) side of the right great toe the size of an eraser on the end of a pencil with a red wound base. Record review of a document obtained from the wound clinic at hospital A on 7/1/2022, evidenced a document titled “Progress Note Details” dated 6/13/2022, which indicated the patient had a pressure ulcer stage II (an open pressure ulcer with partial thickness loss of skin) to the sacrum. Review indicated the patient had a diabetic ulcer to the right great toe with eschar (dry, dark, dead tissue). Review indicated the patient was to follow-up at the wound clinic in 2 weeks. Review of a document titled “Progress Note Details” dated 6/30/2022, indicated the right great toe had necrotic (dead) tissue present and had signs and symptoms of infection. Review indicated the right great toe had a surgical debridement of a 15.58 square centimeters area to include removal of epidermis (top layer of skin), dermis (the thick layer of skin which contains sweat glands, hair follicles, nerve endings, and blood capillaries), subcutaneous tissue (the deepest layer of skin containing fat and connective tissue), muscle, and eschar. Clinical record review on 7/1/2022, failed to evidence an updated comprehensive assessment of the 2 additional wounds to the right great toe. During an interview on 7/1/2022, at 11:15 AM, the patient’s caregiver indicated the wound to the patient’s sacrum was chronic and slow to heal due to the patient’s diabetes (a chronic condition which affects the way the body processes blood sugar). The patient’s caregiver indicated the patient’s wounds to the right toe are new and she noticed them when the patient returned home on 6/6/2022, from the skilled nursing home, after the hospitalization on 5/24/2022. During an interview on 7/1/2022, at 1:06 PM, the clinical manager stated, “We don’t assess the wounds because we don’t take care of the wounds.” The clinical manager indicated the administrator instructed her not to assess the wounds. The clinical manager indicated the agency does not include patient goals and measurable outcomes in the comprehensive assessment because the agency does not take care of the wounds and indicated the agency tries to keep the patient’s goals limited to patient safety. During an interview on 7/1/2022 at 2:16 PM, the administrator indicated wounds should be assessed. At 3:22 PM, when queried why the new wounds noted during the home visit on 6/30/2022, were not assessed, the administrator indicated they should have been and would send the clinical manager to complete a head-to-toe assessment of the patient on 7/5/2022.

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 agency failed to ensure the comprehensive assessment reflected the patient’s current physical and mental status in 2 of 3 active clinical records reviewed with home health aide services. (#1, 2) The findings include: 1. Review of an undated agency policy obtained on 7/6/2022, titled “Comprehensive Assessment of Patients (Admission Policy)” stated, “… Each patient must receive, and BMO Home Health Care, Inc., must provide, a patient-specific comprehensive assessment. … The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: The patient’s current health status, psychosocial, functional, and cognitive status … Patient’s strengths, goals and care preferences, including the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by BMO Home Health Care, Inc. … The Comprehensive Assessment must be updated and revised … as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status ….” 2. Review of an undated agency policy obtained on 7/8/2022, titled “Wound Policy” stated, “… Wounds are to be measured on the first visit of each week … Description of wound and surrounding area including drainage, slough, color, odor, bone/muscle exposure, eschar, or any other observations to clearly describe the wound. All measurements … shall be recorded on all: SOC [start of care], ROC [resumption of care], Re-certifications … Changes in wound assessment ….” 3. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Nursing Visit Record” signed by the registered nurse and dated 6/7/2022. Review indicated the visit was for a resumption of care comprehensive assessment. Review evidenced the patient had a wound to the sacrum (lower back above the buttocks) and a wound to the right great toe. Review failed to evidence the size and description of the sacral wound was assessed. Review of a document from hospital A titled “ED [emergency department] Provider Note” dated 5/24/2022, indicated the patient’s diagnoses included, but were not limited to, diabetes (a chronic condition which affects the way the body processes blood sugar). Review failed to evidence the comprehensive assessment on 6/7/2022 included an assessment of the patient’s diabetes status. During an interview on 7/1/2022, at 1:06 PM, the clinical manager indicated the agency does not assess the patient’s wounds because the agency does not take care of the wounds. The clinical manager indicated she was directed by the administrator to not assess the patient’s wounds. At 1:53 PM, the clinical manager indicated technically the patient was not a diabetic because the patient did not take any diabetic medication. The clinical manager indicated a diabetic patient’s assessment should include signs and symptoms of hyperglycemia (elevated blood sugar) and hypoglycemia (low blood sugar). Review of an agency document titled “Assessment Details” completed by the registered nurse and dated 6/7/2022, indicated the document was the resumption of care assessment. Review failed to evidence the patient’s height and weight was assessed and failed to evidence the patient’s cardiovascular status was assessed. Review indicated the patient had a gastrostomy tube (a plastic tube surgically inserted into the stomach through the abdomen to administer nutrition, fluid, and/or medications). Review failed to evidence the comprehensive assessment to the gastrostomy to include the size of the gastrostomy tube and the description of the stoma (opening). During an interview on 7/1/2022, at 1:14 PM, the clinical manager indicated the program used for the comprehensive assessment does not ask for the size of the gastrostomy tube and stoma description so it was not assessed. 4. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Assessment Details” completed by the clinical manager and dated 5/25/2022, was identified to be the recertification comprehensive assessment. Review failed to evidence the patient’s cardiac status was assessed. The comprehensive assessment failed to evidence the patient’s height and weight was assessed. 5. During an interview on 7/1/2022, at 4:05 PM, the clinical manager indicated the agency does not obtain the patient’s weight and indicated she could assess the patient’s reported height and weight. The clinical manager indicated the patient’s cardiac status should be assessed. 410 IAC 17-14-1(a)(1)(B)

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient’s goals and measurable outcomes were included in the comprehensive assessment in 1 of 1 clinical record reviewed with skilled nursing services. (#1) The findings include: Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Nursing Visit Record” signed by the registered nurse and dated 6/7/2022. Review evidenced the patient had a wound to the sacrum (lower back above the buttocks) and a wound to the right great toe. Review evidenced the patient was NPO (not able to take anything by mouth) and received tube feeding through a peg tube (a tube surgically inserted into the stomach through the abdomen to provide fluid, nutrition, and/or medications). Review of an agency document titled “Assessment Details” completed by the registered nurse and dated 6/7/2022, indicated the document was for a resumption of care comprehensive assessment. Review failed to evidence the assessment included patient goals and measurable outcomes related to the patient’s wounds and peg tube/tube feeding/NPO status. Review indicated the patient’s medications included, but were not limited to, coumadin (a medication which thins the blood and used to treat and/or prevent blood clots). Review failed to evidence the assessment included patient goals and measurable outcomes related to the patient’s coumadin use. Review indicated the patient was assessed to be a fall risk, and the assessment failed to evidence the comprehensive assessment included measurable outcomes related to the risk of falls. During an interview on 7/1/2022, at 1:09 PM, the clinical manager indicated the agency does not include the patient’s goals and measurable outcomes on the assessment because the agency does not take care of the patient’s wounds. At 1:14 PM, the clinical manager indicated there were no goals for the patient’s peg tube because the agency does not provide skilled nursing care but only the respite nurse. The clinical manager indicated the assessment should have included no signs or symptoms of bleeding and patient to use bleeding precautions for measurable outcomes related to the coumadin use. At 1:19 PM, the clinical manager indicated goals related to the risk of falls should have been included in the comprehensive assessment.

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 record review and interview, the agency failed to ensure the comprehensive assessment was updated and revised with changes in the patient’s physical and mental status in 2 of 3 active clinical records reviewed with home health aide services. (#1, 2) The findings include: 1. Review of an undated agency policy obtained on 7/6/2022, titled “Comprehensive Assessment of Patients (Admission Policy)” stated, “… The Comprehensive Assessment must be updated and revised … as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status ….” 2. Review of an undated agency policy obtained on 7/8/2022, titled “Wound Policy” stated, “… Description of wound and surrounding area including drainage, slough, color, odor, bone/muscle exposure, eschar, or any other observations to clearly describe the wound. All measurements … shall be recorded on all: … Changes in wound assessment ….” 3. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced agency documents titled “Nursing Visit Record” signed by the clinical manager and dated 6/7/2022. This document indicated the visit was a resumption of care comprehensive assessment. Review evidenced the patient had a wound to the sacrum (lower back above the buttocks) and one wound to the right great toe. Review indicated the right great toe was red in color. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the patient was observed to have a clear dressing to the sacrum and was observed to have a black area to the top area of the right great toe that continued down the medial (area towards the middle of the body) side of the right great toe with edges pulling away from the surrounding skin. The patient was observed to have a black area to the back side of the right great toe the size of the pinky fingernail and observed to have an open area to the lateral (area away from the middle of the body) side of the right great toe the size of an eraser from the end of a pencil with a red base. Review failed to evidence the comprehensive assessment was updated to include an assessment of the two additional wounds to the right great toe. During an interview on 7/1/2022, at 2:16 PM, the administrator indicated new wounds should be assessed. During an interview on 7/6/2022, at 2:05 PM, the clinical manager indicated the comprehensive assessment had not been updated to include the 2 additional wounds to the right great toe. 4. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Verbal Orders” electronically signed by the registered nurse and dated 4/28/2022. This document stated, “… the patient has been exhibiting behaviors that could be considered dangerous; yelling, screaming, taking handful of pills unscheduled, chasing staff in her wheelchair, grabbing staff by the wrist, throwing objects in her room, leaving house unaccompanied … This is a safety issue to patient as well as home health aide and family. It is requested by this nursing department that patient’s mental health be evaluated at her next visit.” Review failed to indicate the comprehensive assessment was updated to include an assessment of the patient’s behavior. During an interview on 7/1/2022, at 4:05 PM, the clinical manager indicated the comprehensive assessment should have included a follow-up on the patient’s behaviors. 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: An Immediate Jeopardy related to §484.60 Care Planning, Coordination of Services, and Quality of Care was identified and announced on 7/6/2021 at 10:47 AM. The Immediate Jeopardy began on 6/7/2022 when the agency resumed care for patient #1 after a hospitalization on 5/24/2022 followed by an admission at a skilled nursing facility. An order to resume care was obtained on 6/7/2022. The registered nurse documented the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the sacrum (lower back above the buttocks) and a diabetic wound to the right great toe. The registered nurse assessed the patient to have a g-tube (a tube surgically inserted into the stomach through the abdomen for the administration of fluids, nutrition, and/or medications). Patient was assessed to be incontinent of urine and feces, bedbound, and unable to reposition self. The skilled nurse provided wound care to the right great toe wound on 6/7/2022. The skilled nurse on 6/8/2022 noted a wound to the sacrum and a wound to the right great toe. No additional skilled nurse visits were provided. Patient received wound care from a wound clinic, and the agency failed to incorporate wound care orders from the wound clinic into the patient’s plan of care. The agency failed to coordinate care with the wound clinic. During a home visit on 6/30/2022 for observation of care with the home health aide, the patient was observed to have 1 wound to the sacrum and 3 wounds to the right great toe. The registered nurse was observed to flush the g-tube with a clear liquid. The agency failed to notify the physician of the additional wounds and obtain treatment orders. The plan of care indicated the patient was to receive respite skilled nursing care at the caregiver’s request, and the plan of care failed to be individualized to include the wound locations, wound treatment orders for the sacral wound and right great toe wounds, and g-tube orders. An additional clinical record review for patient #2 indicated the home health aide reported to the registered nurse on 4/28/2022 the patient had been exhibiting behaviors to include taking a handful of unscheduled, unidentified medication. The agency reports to provide social work services, but no social work services have been provided to the patient. The agency’s active personnel does not include a social worker and there is not a contract for social work services. 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. Other unrelated conditions of participation and findings will be cited. A standard deficiency was also found as follows: Based on observation, record review and interview, the home health agency failed to ensure the patient needs were met in regards to the provision of skilled nursing services for wound care and social work services; failed to ensure the plan of care was complete and individualized to include interventions and goals for wounds and behaviors; failed to ensure the plan of care incorporated wound care orders from the wound care clinic; and failed to ensure the physician was notified of wound care status and new wounds in 1 of 1 home visits conducted with a patient with wounds (#1) and in 1 of 1 clinical records reviewed with reported behaviors (#2). This practice has the potential to affect all bedbound patients, patients at risk for skin impairment, patients with wounds, and patients in need of social work services. The findings include: 1. Review of an undated agency policy obtained 7/6/2022, titled “Plan of Care (485)” stated, “… Patients are accepted for treatment on the reasonable expectation that a Home Health Agency can meet the patient’s medical, nursing, rehabilitative, and social needs … 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 … the measurable outcomes that the Home Health Agency anticipates will occur as a result of implementing and coordinating the plan of care. … Each patient must receive the home health services that are written in an individualized plan of care … The individualized plan of care must include the following … The types of services, supplies, and equipment required … Patient-specific interventions … measurable outcomes and goals identified by the Home Health Agency and patient … All patient care orders, including verbal orders, must be recorded in the plan of care. … Drugs, services, and treatments are administered only as ordered by a physician … BMO Home Health Care, Inc., must promptly alert the relevant physician(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. A revised plan of care must reflect the current information from the patient’s updated comprehensive assessment ….” 2. Review of an undated agency policy obtained 7/6/2022, titled “Skilled Professional Services/Responsibilities of Skilled Professionals” stated, “… Skilled Professional Services include … skilled nursing services … medial social work services ….” 3. Review of an undated agency policy obtained 7/6/2022, titled “Coordination of Care” stated, “… Integrate orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient ….” 4. Review of the agency’s admission packet on 6/29/2022, evidenced an undated agency document titled “Welcome Letter and Hours of Operation” which stated, “… Our services include the following: … Skilled Nursing … Medical Social Worker ….” 5. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 5/18/2022 – 7/16/2022. Review indicated the agency was to provide home health aide services 10 hours a day, 7 days a week and respite skilled nursing services 96 hours per month at caregiver’s request. Review evidenced an agency document titled “Nursing Visit Record” signed by the clinical manager and dated 5/10/2022. Review indicated the patient had a wound to the sacrum. Review failed to evidence the plan of care was individualized to include the wound location, wound treatment orders, and measurable outcomes and goals related to the wound to the sacrum. Review of an agency document titled “Verbal Order” dated 5/25/2022, indicated the patient was admitted to the hospital on 5/24/2022, and agency services were on hold. No skilled nursing visits were provided after 5/10/2022, prior to the hospitalization on 5/24/2022. Review of agency documents titled “Nursing Visit Record” signed by the clinical manager, evidenced the patient had a wound to the sacrum and a wound to the right great toe on document dated 6/7/2022. Review indicated the right great toe was red in color. Review indicated the document was the resumption comprehensive assessment and failed to evidence the physician was notified of the new wound to the right great toe. Review indicated the patient had a g-tube and received a tube feeding formula through the g-tube. Review failed to evidence the plan of care included orders for the g-tube care and flushes. Review of the document dated 6/8/2022, evidenced the registered nurse cleansed the wound to the right great toe with normal saline (a wound cleansing solution) and applied a bandage. Review failed to evidence an order for the wound treatment to the right great toe provided by the registered nurse. Review failed to evidence the plan of care was revised to include the wound location, wound treatment orders, and measurable outcomes and goals related to the wound to the right great toe. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the clinical manager indicated the patient was getting picked-up by transport at 11:30 AM, for an appointment at the wound clinic. The patient was observed with a plastic tube inserted into her abdomen which was connected to a machine on a pole next to the bed. The clinical manager indicated she was going to take care of the g-tube while she was here observing the home health aide visit. The clinical manager was observed turning off the machine on a pole next to the bed and disconnecting the tube. The clinical manager was observed pouring water obtained from the sink into the patient’s tube through a large syringe inserted into the tube. The clinical manager filled the large syringe with water and allowed the water to drain into the tube and was observed filling the syringe for a second time with water which drained into the tube. The patient was observed to have a clear dressing to the sacrum and was observed to have a black area to the top area of the right great toe that continued down the medial (area towards the middle of the body) side of the right great toe with edges pulling away from the surrounding skin. The patient was observed to have a black area to the back side of the right great toe the size of the pinky fingernail and observed to have an open area to the lateral (area away from the middle of the body) side of the right great toe the size of an eraser from the end of a pencil with a red base. The right great toe was not observed to have a wound treatment applied. Record review of a document obtained from the wound clinic at hospital A on 7/1/2022, evidenced a document titled “Progress Note Details” dated 6/13/2022, which indicated the patient had a pressure ulcer stage II (an open pressure ulcer with partial thickness loss of skin) to the sacrum and with wound treatment orders to cleanse with normal saline and apply silver alginate (an absorbent antimicrobial wound treatment) dressing 3 times a week. Review indicated the patient had a diabetic ulcer to the right great toe with eschar (dry, dark, dead tissue) and with wound treatment orders to cleanse with normal saline and apply Bactroban (an antibiotic ointment) and wrap with gauze daily. Review indicated the patient was to follow-up at the wound clinic in 2 weeks. Review failed to evidence the wound treatment orders were incorporated into the plan of care. Review failed to evidence the physician was aware of the services provided by the wound care clinic and failed to evidence the physician was aware of the change in wound status from a red wound base to eschar. Review failed to evidence the agency coordinated care with the wound care clinic. Review of a document titled “Progress Note Details” dated 6/30/2022, indicated the right great toe had necrotic (dead) tissue present and had signs and symptoms of infection. Review indicated the right great toe had a surgical debridement of a 15.58 square centimeters area to include removal of epidermis (top layer of skin), dermis (the thick layer of skin which contains sweat glands, hair follicles, nerve endings, and blood capillaries), subcutaneous tissue (the deepest layer of skin containing fat and connective tissue), muscle, and eschar. Review indicated the right great toe was to be cleansed with normal saline, apply Iodosorb (an antimicrobial dressing which removes wound debris and forms a gel over the wound surface), and wrap with gauze 3 times a week. Review indicated the patient was to follow-up at the wound clinic in 2 weeks. Review failed to evidence the physician was notified of the right great toe debridement and of the change in wound treatment orders from the wound clinic physician. During an interview on 7/1/2022, at 11:15 AM, the patient’s caregiver indicated the wound to the patient’s sacrum was chronic and slow to heal, due to the patient’s diabetes (a chronic condition which affects the way the body processes blood sugar). The patient’s caregiver indicated the patient’s wounds to the right toe are new and she noticed them when the patient returned home on 6/6/2022, from the skilled nursing home after the hospitalization on 5/24/2022. The patient’s caregiver indicated she took the patient to the wound clinic at hospital A for assistance in managing the wounds. The patient’s caregiver indicated the agency used to provide a nurse, but does not have any nurses to send routinely now, and the caregiver indicated the agency does provide a respite nurse occasionally. The caregiver stated, “I have begged for nursing care since August.” The patient’s caregiver indicated she has tried to call other agencies seeking skilled nursing care, but either the agencies don’t have staff or won’t come to Gary where the patient resides. The patient’s caregiver indicated she would prefer to keep her home health aide services with the current agency. The patient’s caregiver indicated shewas able to provide the patient’s wound care and has learned how to provide wound care from the wound clinic and the nurse. During an interview on 7/1/2022, at 11:30 AM, person B, medical assistant for the patient’s physician responsible for the plan of care, indicated there has been no communication from the agency related to wounds. During an interview on 7/1/2022, at 1:31 PM, the clinical manager indicated there was no coordination of care with the wound clinic. The clinical manager indicated the agency does not have wound care orders because the agency does not do anything with the wounds. The clinical manager stated, “We never individualized the plan of care like that because we just do respite nursing.” During an interview on 7/1/2022 at 2:16 PM, the administrator indicated wounds should be reported to the physician and should have wound treatment orders. The administrator indicated she did not know respite nursing care was considered skilled nursing services since it was provided by Medicaid waiver. 6. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Verbal Orders” electronically signed by the registered nurse and dated 4/28/2022. This document stated, “… the patient has been exhibiting behaviors that could be considered dangerous; yelling, screaming, taking handful of pills unscheduled, chasing staff in her wheelchair, grabbing staff by the wrist, throwing objects in her room, leaving house unaccompanied … This is a safety issue to patient as well as home health aide and family. It is requested by this nursing department that patient’s mental health be evaluated at her next visit.” Review failed to evidence the agency provided social work services and failed to evidence a mental health evaluation for the patient. Review of an agency document titled “Assessment Details” completed by the registered nurse and dated 5/25/2022, was identified to be the recertification comprehensive assessment. This document indicated the patient was unsafe to leave the home unassisted, had a bilateral above the knee amputation, and required assistance with personal care and transferring. Review indicated the registered nurse assessed the patient’s emotional and behavioral status to include agitation and difficulty coping with altered health status. Review of an agency document titled “Home Health Plan of Care [and] Certification” for certification period 5/26/2022 – 7/24/2022, failed to evidence the patient had a mental health diagnosis. Review failed to evidence medical social work services were to be provided. Review failed to evidence interventions and goals related to the patient’s reported behaviors were included in the plan of care. During an interview on 7/1/2022, at 3:58 PM, the administrator indicated the agency does not have an employed social worker at this time. The administrator indicated the agency does not have a contract for social work services. The administrator indicated they are not aware of a mental health evaluation for the patient, but requested the physician perform one at the patient’s next appointment. When queried about what follow-up has been made since the request on 4/28/2022, for the patient to receive a mental health evaluation at the next physician appointment, the administrator indicated there was none. During an interview on 7/1/2022, at 4:09 PM, the clinical manager indicated she was not aware of a mental health diagnosis for the patient. The clinical manager indicated the agency does not individualize the plans of care to include interventions and goals which address the patient’s reported behaviors because the agency does not provide skilled nursing and social work services to this patient. 410 IAC 17-13-1(a)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aide services were provided to the patient per the ordered frequency as directed in the plan of care in 1 of 1 clinical record reviewed with skilled nursing services. (#1) The findings include: Review of an undated agency policy obtained 7/6/2022, titled “Plan of Care (485)” stated, “… Each patient must receive the home health services that are written in an individualized plan of care ….” Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 3/19/2022 – 5/17/2022. Review indicated the agency was to provide home health aide services 12 hours a day on Mondays and Thursdays and 10 hours a day on Sundays, Tuesdays, Wednesdays, Fridays, and Saturdays. Review failed to evidence home health aide services were provided on 5/1/2022 and 5/8/2022. Review failed to evidence the agency provided home health aide services for 12 hours on the following Mondays: 5/2/2022, 5/9/2022, and 5/16/2022. Review failed to evidence the agency provided home health aide services for 12 hours on the following Thursdays: 5/5/2022 and 5/12/2022. Review of the plan of care for certification period 5/18/2022 – 7/16/2022 indicated the patient was to receive home health aide services 10 hours a day, 7 days a week. Review failed to evidence the agency provided home health aide services on 6/12/2022 as directed in the plan of care. During an interview on 7/1/2022, at 1:40 PM, the clinical manager indicated the agency did not have staff to provide home health aide services as directed in the plan of care. 410 IAC 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the plan of care was individualized to include all diagnoses, medications, medical equipment and supplies, services, treatments, safety precautions, and patient-specific interventions in 3 of 3 active clinical records reviewed with home health aide services. (#1, 2, 3) The findings include: 1. Review of an undated agency policy obtained 7/6/2022, titled “Plan of Care (485)” stated, “… 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 … All pertinent diagnoses … The types of services, supplies, and equipment required … The frequency and duration of visits to be made … Rehabilitation potential … All medications and treatments … Safety measures to protect against injury … all necessary interventions to address the underlying risk factors … Patient-specific interventions and education; measurable outcomes and goals identified by the Home Health Agency and the patient ….” 2. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 5/18/2022 – 7/16/2022. Review indicated the agency was to provide home health aide services and respite nursing services. Review indicated the patient’s mediations included, but were not limited to, clopidogrel (a medication used to thin the blood increasing the risk of bleeding), Tylenol PM (a medication used to treat pain at bedtime) as needed, Tylenol Allergy Multi-Symptom (a medication used to treat allergy symptoms) as needed, Mucinex (a medication used to treat upper respiratory infection symptoms) as needed, Tylenol (a medication used to treat pain) as needed, and Afrin (a nasal decongestant) 1-2 sprays per nostril as needed. Review failed to evidence the plan of care was individualized to include the indications for use as needed and failed to evidence the plan of care was individualized with instructions on when to take 1 spray or 2 sprays as needed. Review indicated the patient’s medical equipment and supplies included urinary ostomy (a hole surgically created into the bladder through the abdomen to drain urine) supplies. Review failed to evidence the patient had a urinary ostomy. Review failed to evidence the plan of care was individualized to include bleeding precautions as a safety measure. During an interview on 7/1/2022, at 12:56 PM, the clinical manager indicated Tylenol Allergies was for allergy symptoms, Tylenol PM was for pain, Mucinex was for secretions, and Afrin was for allergy symptoms. The clinical manager indicated whether the patient took 1 or 2 sprays of Afrin depended on how bad the symptoms were and indicated the plan of care did not indicate the directions for when to take 1 or 2 sprays. The clinical manager indicated the plan of care should not have included urinary ostomy supplies because the patient did not have a urinary ostomy. Review of an agency document titled “Assessment Details” completed by the registered nurse and dated 5/18/2022, indicated the patient’s functional limitation included ambulation. The plan of care failed to evidence ambulation was included as a functional limitation. Review indicated the patient was assessed to be a fall risk, and the plan of care failed to evidence interventions to mitigate the risk of falls were included. Review indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to an unmentioned location and a peg tube (a tube surgically inserted into the stomach through the abdomen to administer nutrition, fluid, and/or medications) through which the patient received tube feeding formula. Review failed to evidence the plan of care included orders for the peg tube care, the location of the wound, wound treatment orders, and measurable outcomes and goals related to the wound and peg tube. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the patient was observed to be wearing heel protector boots to both feet. The plan of care failed to be individualized to include the directions for the heel protector boots. Review of documentation obtained from hospital A on 7/1/2022, evidenced the patient was admitted to the hospital on 5/24/2022. The patient’s diagnoses included, but were not limited to, diabetes (a chronic condition which affects the way the body processes blood sugar). Review failed to evidence the plan of care was individualized to include the diagnosis of diabetes. During an interview on 7/1/2022, at 1:17 PM, the clinical manager indicated ambulation should have been marked as a functional limitation on the plan of care. The clinical manager indicated the patient was at risk for falls and the plan of care should have included keeping the side rails up. The clinical manager indicated bleeding precautions should be included in the plan of care. The clinical manager indicated the agency tries to limit the goals to safety since the agency does not provide skilled nursing. The clinical manager indicated the patient wears the heel protector boots daily but stated, “It just depends on how often. We take them off prn [as needed] for turning. Doesn’t sleep in them.” The clinical manager indicated the patient was not diabetic because the patient did not take any diabetic medication. The clinical manager indicated the plan of care for patients that were diabetic should include the skilled nurse to assess for signs of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar). 3. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2019, evidenced an agency document titled “Verbal Orders” electronically signed by the registered nurse and dated 4/28/2022. This document stated, “… the patient has been exhibiting behaviors that could be considered dangerous; yelling, screaming, taking handful of pills unscheduled, chasing staff in her wheelchair, grabbing staff by the wrist, throwing objects in her room, leaving house unaccompanied … This is a safety issue to patient as well as home health aide and family. It is requested by this nursing department that patient’s mental health be evaluated at her next visit.” During an observation of care at the patient’s home on 6/29/2022, at 5:03 PM, the patient was observed sitting in a motorized wheelchair. The patient was observed to have a hospital bed and hoyer lift (a mechanical lift device) in the patient’s bedroom. Review of an agency document titled “Home Health Plan of Care [and] Certification” for certification period 5/26/2022 – 7/24/2022, failed to evidence the patient had a mental health diagnosis. Review failed to evidence medical social work services were to be provided. Review failed to evidence interventions and goals related to the patient’s reported behaviors were included in the plan of care. Review indicated the patient had seizures, and the plan of care did not include seizure precautions in the safety measures. Review indicated the patient’s medications included, but were not limited to, coumadin (a medication used to treat or prevent blood clots which thins the blood increasing the risk of bleeding). Review failed to evidence bleeding precautions were included in the safety measures. Review failed to evidence what activities were permitted. Review indicated the agency was to provide home health aide services for personal care. Review failed to include the frequency of the home health aide visits. Review failed to evidence the plan of care had medical equipment and supplies to include the motorized wheelchair, hospital bed, and hoyer lift. During an interview on 7/1/2022, at 1:50 PM, the clinical manager indicated the agency tries to keep the goals on the plan of care limited to safety. The clinical manager indicated the agency does not individualize the plan of care with patient-specific goals because the agency does not provide a skilled nurse. During an interview on 7/1/2022, at 3:45 PM, the administrator indicated the activities permitted should have been marked on the plan of care. The administrator indicated bleeding and seizure precautions should have been included as safety measures in the plan of care. The administrator indicated she would have to check on what was the home health aide frequency and indicated it should have been included in the plan of care. The administrator indicated the medical equipment should be included in the plan of care. 4. Clinical record review on 7/1/2022, for patient #3, start of care 3/17/2022, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 3/17/2022 – 5/15/2022. This document indicated the patient’s medications included, but were not limited to, oxycodone (a narcotic pain-relieving medication) as needed. Review failed to evidence the plan of care was individualized to include the indications for use. Review indicated the patient’s rehabilitation potential was not applicable and failed to evidence the plan of care was individualized to include the rehabilitation potential. During an interview on 7/1/2022, at 3:36 PM, the clinical manager indicated the oxycodone was for pain and the indication for use should be included in the plan of care. The clinical manager indicated she assumed the rehabilitation potential only applied if the patient was receiving physical therapy and indicated the patient was not receiving physical therapy. 410 IAC 17-13-1(a)(1)(D)(ii, iii, v, vi, ix, x, xiii)

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure treatments and services were provided only as ordered by a physician in 1 of 1 clinical record reviewed with skilled nursing services. (#1) The findings include: Review of an undated agency policy obtained 7/6/2022, titled “Plan of Care (485)” stated, “… Drugs, services, and treatments are administered only as ordered by a physician ….” Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced agency documents titled “Nursing Visit Record” signed by the registered nurse. Review of document dated 5/2/2022 indicated the patient had a wound to the sacrum (lower back above the buttocks) and a peg tube (a surgically inserted tube into the stomach through the abdomen to administer nutrition, fluid, and/or medication). Review indicated the nurse provided wound care, flushed the peg tube, administered medications via the peg tube, and initiated the peg tube feeding. Review of document dated 5/3/2022 indicated the nurse provided wound care. Review of document dated 5/4/2022 indicated the nurse provided wound care, initiated the peg tube feeding, and administered medications via the peg tube. Review of document dated 5/5/2022 indicated the nurse provided wound care and administered medications via the peg tube. Review of document dated 5/6/2022 indicated the nurse provided wound and peg tube care and administered medications via the peg tube. Review of document dated 5/10/2022 indicated the nurse provided wound care. Review of document dated 6/8/2022 indicated the nurse flushed the peg tube and administered medications via the peg tube. Review of document dated 6/8/2022 indicated the nurse administered medications via the peg tube. Review failed to evidence physician orders for wound care, peg tube flushes and feeding, and medication administration. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the patient was observed with a plastic tube inserted into her abdomen which was connected to a machine on a pole next to the bed. The clinical manager indicated she was going to take care of the peg tube while she was here observing the home health aide visit. The clinical manager was observed turning off the machine on a pole next to the bed and disconnecting the tube inserted into the abdomen. The clinical manager was observed pouring water obtained from the sink into the tube through a large syringe inserted into the tube. The clinical manager filled the large syringe with water and allowed the water to drain into the tube and was observed filling the syringe for a second time with water which drained into the tube. During an interview on 7/1/2022, at 1:31 PM, the clinical manager indicated the agency technically does not have wound care and peg tube orders because the agency does not provide skilled nursing care but respite nursing care. When queried how the nurse knows what wound and peg tube care to provide, the clinical manager indicated the nurse does whatever the caregiver says. The clinical manager indicated the agency does not have record of what medications were administered and at what time and indicated the agency does not have an order to administer medications. 410 IAC 17-13-1(a)

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was reviewed by the physician responsible for the plan of care no less than every 60 days in 2 of 3 active clinical records reviewed with home health aide services. (#1, 3) The findings include: 1. Review of an undated agency policy obtained 7/6/2022, titled “Plan of Care (485)” stated, “…The individualized plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care … no less frequently than once very [sic] 60 days ….” 2. Clinical record review for patient #1, start of care 6/3/2019, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 3/19/2022 - 5/17/2022, was signed by the physician on 4/8/2022. Review of an agency document titled “Home Health Plan of Care [and] Certification” for certification period 5/18/2022 – 7/16/2022, was signed by the physician on 6/29/2022. Review failed to evidence the physician responsible for the plan of care reviewed the plan of care every 60 days. 3. Clinical record review on 7/1/2022, for patient #3, start of care 3/17/2022, evidenced agency documents titled “Home Health Plan of Care [and] Certification”. Review evidenced the document for certification period 3/17/2022 – 5/15/2022, was signed by the physician on 4/5/2022. Review evidenced the document for certification period 5/16/2022 – 7/14/2022, was signed by the physician on 6/22/2022. Review failed to evidence the physician responsible for the plan of care reviewed the plan of care every 60 days. 4. During an interview on 7/1/2022, at 12:55 PM, the clinical manager indicated the physician should review the plan of care every certification period. 5. During an interview on 7/1/2022, at 3:37 PM, the administrator indicated the physicians do not always send back the plans of care timely. 410 IAC 17-13-1(a)(2)

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 or needs that suggest outcomes are not being achieved and/or the plan of care should be altered in 1 of 1 clinical record reviewed with wounds. (#1) The findings include: Review of an undated agency policy obtained on 7/8/2022, titled “Wound Policy” stated, “… All changes in wound condition shall be reported to the physician and documentation will include the individual whom the nurse spoke to; what orders were provided; and/or what direction was provided….” Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Nursing Visit Record” signed by the clinical manager and dated 5/10/2022. Review indicated the patient had a wound to the sacrum (lower back above the buttocks). Review of an agency document titled “Verbal Order” dated 5/25/2022, indicated the patient was admitted to the hospital on 5/24/2022 and agency services were on hold. No skilled nursing visits were provided after 5/10/2022 prior to the hospitalization on 5/24/2022. Review of agency documents titled “Nursing Visit Record” signed by the clinical manager evidenced the patient had a wound to the sacrum and a wound to the right great toe on document dated 6/7/2022. Review indicated the right great toe was red in color. Review indicated the document was the resumption comprehensive assessment and failed to evidence the physician was notified of the new wound to the right great toe. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the patient was observed to have a clear dressing to the sacrum and was observed to have a black area to the top area of the right great toe that continued down the medial (area towards the middle of the body) side of the right great toe with edges pulling away from the surrounding skin. The patient was observed to have a black area to the back side of the right great toe the size of the pinky fingernail and observed to have an open area to the lateral (area away from the middle of the body) side of the right great toe the size of an eraser from the end of a pencil with a red base. Record review of a document obtained from the wound clinic at hospital A on 7/1/2022, evidenced a document titled “Progress Note Details” dated 6/13/2022, which indicated the patient had a pressure ulcer stage II (an open pressure ulcer with partial thickness loss of skin) to the sacrum and with wound treatment orders to cleanse with normal saline and apply silver alginate (an absorbent antimicrobial wound treatment) dressing 3 times a week. Review indicated the patient had a diabetic ulcer to the right great toe with eschar (dry, dark, dead tissue) and with wound treatment orders to cleanse with normal saline and apply Bactroban (an antibiotic ointment) and wrap with gauze daily. Review failed to evidence the agency notified the physician of the services provided by the wound care clinic and failed to evidence the physician was aware of the change in wound status from a red wound base to eschar on the right great toe. Review of a document titled “Progress Note Details” dated 6/30/2022, indicated the right great toe had necrotic (dead) tissue present and had signs and symptoms of infection. Review indicated the right great toe had a surgical debridement of a 15.58 square centimeters area to include removal of epidermis (top layer of skin), dermis (the thick layer of skin which contains sweat glands, hair follicles, nerve endings, and blood capillaries), subcutaneous tissue (the deepest layer of skin containing fat and connective tissue), muscle, and eschar. Review indicated the right great toe was to be cleansed with normal saline, apply Iodosorb (an antimicrobial dressing which removes wound debris and forms a gel over the wound surface), and wrap with gauze 3 times a week. Review indicated the patient was to follow-up at the wound clinic in 2 weeks. Review failed to evidence the agency notified the physician of the right great toe debridement and of the change in wound treatment orders from the wound clinic physician. During an interview on 7/1/2022, at 11:30 AM, person B, medical assistant for the patient’s physician responsible for the plan of care, indicated there has been no communication from the agency related to wounds. During an interview on 7/1/2022 at 2:16 PM, the administrator indicated wounds should be reported to the physician and should have wound treatment orders. 410 IAC 17-13-1(a)(2)

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to integrate all orders into the plan of care in 1 of 1 clinical record reviewed with wounds. (#1) The findings include: Review of an undated agency policy obtained 7/8/2022, titled “Plan of Care (485)” stated, “… All patient care orders, including verbal orders, must be recorded in the plan of care….” Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Assessment Details” completed by the registered nurse and dated 5/18/2022. Review indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to an unmentioned location. Review of a document obtained from the wound clinic at hospital A on 7/1/2022, evidenced a document titled “Progress Note Details” dated 6/13/2022, which indicated the patient had a pressure ulcer stage II (an open pressure ulcer with partial thickness loss of skin) to the sacrum (lower back above the buttocks) and with wound treatment orders to cleanse with normal saline and apply silver alginate (an absorbent antimicrobial wound treatment) dressing 3 times a week. Review indicated the patient had a diabetic ulcer to the right great toe with eschar (dry, dark, dead tissue) and with wound treatment orders to cleanse with normal saline and apply Bactroban (an antibiotic ointment) and wrap with gauze daily. Review indicated the patient was to follow-up at the wound clinic in 2 weeks. Review failed to evidence the wound treatment orders were incorporated into the plan of care. During an interview on 7/1/2022, at 2:16 PM, the administrator indicated the agency should have had the wound care orders from the wound clinic and should have added them to the plan of care. 410 IAC 17-12-2(h)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care with the wound clinic providing care in 1 of 1 clinical record reviewed with wounds. (#1) The findings include: Review of an undated agency policy obtained 7/6/2022, titled “Coordination of Care” stated, “… Integrate orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient ….” Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Nursing Visit Record” signed by the clinical manager and dated 6/7/2022. Review evidenced the patient had a wound to the sacrum (lower back) and a wound to the right great toe. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the clinical manager indicated the patient was getting picked-up by transport at 11:30 AM for an appointment at the wound clinic. The patient was observed to have a clear dressing to the sacrum and was observed to have a black area to the top area of the right great toe that continued down the medial (area towards the middle of the body) side of the right great toe with edges pulling away from the surrounding skin. The patient was observed to have a black area to the back side of the right great toe the size of the pinky fingernail and observed to have an open area to the lateral (area away from the middle of the body) side of the right great toe the size of an eraser from the end of a pencil with a red base. Record review failed to evidence documentation from the wound clinic and failed to evidence coordination of care with the wound clinic. During an interview on 7/1/2022, at 1:31 PM, the clinical manager indicated she did not see any documentation and care coordination with the wound clinic. 410 IAC 17-12-2(h)

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide the patient and caregiver in writing with the name and contact information of the clinical manager in 2 of 2 home visits conducted. (#1, 2) The findings include: 1. During an interview at the entrance conference on 6/29/2022, at 10:41 AM, the administrator indicated the clinical manager was registered nurse (RN) #1. 2. Review of the agency’s admission packet on 6/29/2022, evidenced an undated agency document titled “Welcome Letter and Hours of Operation” which indicated person C was the clinical manager. 3. During an observation of care on 6/30/2022, at 10:03 AM, for patient #1, start of care 6/3/2019, the agency folder was observed in the patient’s home. Inside of the folder, an undated agency document titled “Welcome Letter and Hours of Operation” was observed. Review indicated person C was the clinical manager. 4. During an observation of care on 6/29/2022, at 5:03 PM, for patient #2, start of care 6/11/2019, the agency folder was observed in the patient’s home. Inside of the folder, an undated agency document titled “Welcome Letter and Hours of Operation” was observed. Review indicated person C was the clinical manager. 5. During an interview on 7/1/2022, at 1:23 PM, when queried how the patient was notified in writing who was the clinical manager, the clinical manager indicated the clinical manager was named in the admission packet. When queried if the admission packet was correct, the clinical manager indicated the administrator needed to update it because it was incorrect. 6. During an interview on 7/1/2022, at 2:14 PM, the administrator indicated person C used to the be the clinical manger until her time of separation from the agency sometime in November 2021.

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 agency failed to ensure the performance improvement activities focused on high risk areas. The findings include: Review of an undated agency policy obtained on 7/6/2022, titled “QAPI [Quality Assessment Performance Improvement]” stated, “… BMO’s performance improvement activities must: Focus on high risk, high volume, or problem-prone areas ….” Clinical record review indicated patient #1, start of care 6/3/2019, received respite nursing services and had a chronic wound to the sacrum (lower back above the buttock). Review of the agency’s QAPI program on 7/6/2022, failed to evidence performance improvement activities which focused on patients with wounds. During an interview on 7/6/2022, at 3:10 PM, the administrator indicated she was not aware the agency had to do anything with wounds since the agency did not provide skilled nursing services.

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 document a performance improvement project. The findings include: Review of an undated agency policy obtained on 7/6/2022, titled “QAPI [Quality Assessment Performance Improvement]” stated, “… Performance Improvement Projects: The number and scope of distinct projects that BMO will conduct annually must reflect the scope, complexity, and past performance of BMO services and operations….” Review of the agency’s QAPI program on 7/6/2022 failed to evidence performance improvement projects. During an interview on 7/6/2022, at 3:10 PM, the administrator indicated the agency did not have any performance improvement projects. The administrator stated, “I really didn’t know I had anything going on with my patients.”

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all employees practiced standard/universal precautions to prevent the transmission of infections and failed to follow agency infection control policies and procedures in 2 of 2 home visits. (#1, 2) The findings include: 1. Review of an undated agency policy obtained 7/6/2022, titled “Infection Prevention Program” stated, “… Standard precautions is the use of gloves … to prevent any exposure to blood or other potentially infectious body fluids. Standard Precautions apply to … non-intact skin … This Agency will follow standard precautions at all times ….” 2. Review of the agency admission packet evidenced an undated agency document titled “Indiana Universal Precautions and Infectious Waste Regulations” which stated, “… Hands are washed after removal of gloves ….” 3. During an observation of care at the home of patient #1, start of care 6/3/2019, on 6/30/2022, at 10:20 AM, home health aide (HHA) #1 was observed washing the patient in bed. HHA #1 was observed washing the patient’s chest and arms, the front of the legs, genitals, and perineal area (the space between the genitals and the anus) while wearing gloves. HHA #1 was observed rolling patient in the bed to the patient’s left side and was observed washing the patient’s back, the back of the legs, and the buttocks while wearing gloves. HHA #1 was not observed removing gloves and performing hand hygiene after washing the patient’s genitals and perineal area and before washing the patient’s back and back of legs. 4. During an observation of care at the home of patient #2, start of care 6/11/2019, on 6/29/2022, at 5:40 PM, HHA #2 was observed to have removed gloves to both hands, retrieve laundry basket, and remove a bottle of water from the patient’s refrigerator and place bottle on the patient’s overbed table. HHA 2 was not observed performing hand hygiene after removing gloves. 5. During an interview on 7/1/2022, at 3:30 PM, the administrator indicated staff should remove gloves and apply hand sanitizer after washing the perineal area and before washing the patient’s back. The administrator indicated staff should apply hand sanitizer after removing gloves. 410 IAC 17-12-1(m)

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation and record review, the registered nurse failed to report to the physician vital signs outside of the ordered parameters as directed in the plan of care, in 1 of 1 clinical record reviewed with skilled nursing services. (#1) The findings include: Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 3/19/2022 – 5/17/2022. Review indicated the physician was to be notified for a pulse rate less than 60 beats per minute. Review of agency documents titled “Nursing Visit Record” signed by the registered nurse indicated the patient’s pulse was 59 beats per minute on document dated 5/3//2022, 56 beats per minute on document dated 5/6/2022, and 58 beats per minute on documents dated 5/5/2022 and 5/10/2022. Review failed to evidence the registered nurse notified the physician as directed in the plan of care. 410 IAC 17-14-1(a)(1)(H)

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 skilled nurse failed to prepare clinical notes accurately and completely in 2 of 3 active clinical records reviewed receiving home health aide services. (#1, 2) The findings include: 1. Review of an undated agency policy obtained 7/8/2022, titled “Clinical Record Content/Medical Record Retention” stated, “… Clinical records are legal documents containing comprehensive, accurate, and organized information …The individual must put time of visit/call, date (month, day, year) and sign the entry, complete with his or her title to authenticate an entry in the clinical record….” 2. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Assessment Details” dated 6/7/2022. Review failed to indicate the clinician prepared the clinical document to include signature and title. During an interview on 7/6/2022, 10:26 PM, the clinical manager indicated she completed the assessment on 6/7/2022. The clinical manager indicated the program used to enter the assessment sometimes does not print the clinician’s electronic signature. Review of an agency document titled “Nursing Visit Record” signed by the registered nurse and dated 6/7/2022, indicated the registered nurse flushed the patient’s gastrostomy tube (a tube surgically inserted into the stomach through the abdomen to provide nutrition, fluids, and/or medication) and the gastrostomy flushed well. Review failed to evidence the registered nurse completed the note to include with what the gastrostomy tube was flushed and with how much. During an interview on 7/1/2022, at 1:36 PM, the clinical manager indicated she flushed the patient’s gastrostomy tube with water and usually flushes with 100-150 milliliters. During an observation of care at the patient’s home on 6/30/2022, at 10:03 AM, the patient was observed with a plastic tube inserted into her abdomen which was connected to a machine on a pole next to the bed. The clinical manager indicated she was going to take care of the gastrostomy tube while she was here observing the home health aide visit. The clinical manager was observed turning off the machine on a pole next to the bed and disconnecting the tube. The clinical manager was observed pouring water obtained from the sink into the patient’s tube through a large syringe inserted into the tube. The clinical manager filled the large syringe with water and allowed the water to drain into the tube and was observed filling the syringe for a second time with water which drained into the tube. Review failed to evidence the clinical manager prepared a clinical note for the care provided by the clinical manager at the patient’s home on 6/30/2022. During an interview on 7/6/2022, at 10:30 AM, when queried where was the documentation of the care provided at the patient’s home on 6/30/2022, the clinical manager indicated she did not know she was supposed to document care since she was there for the observation of the home health aide. 3. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Nursing Visit Record” signed by the clinical manager and dated 5/25/2022, and identified to be a recertification comprehensive assessment. Review indicated the patient’s pulse was 60 beats per minute and the patient’s blood pressure was 127/89. Review of an agency document titled “Assessment Details” completed by the clinical manager and dated 5/25/2022, was identified as a recertification assessment. Review indicated the patient’s pulse was 64 beats per minute and the patient’s blood pressure was 132/84. During an interview on 7/1/2022, at 4:06 PM, the clinical manager indicated both documents were the recertification comprehensive assessment and from the same assessment. The clinical manager indicated she was not sure which blood pressure and pulse was correct and indicated the blood pressure and pulse from both documents could not be correct. 410 IAC 17-14-1(a)(1)(E)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aides had complete, patient-specific written patient care instructions to be performed by the home health aides in 2 of 3 active clinical records reviewed with home health aide services. (#1, 2) The findings include: 1. Review of an undated agency policy obtained 7/8/2022, titled “Home Health Aide Visit Protocol” stated, “… The aide: Receives verbal or written instruction for patient care from the patient’s home health care registered nurse….” 2. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Assessment Details” completed by the registered nurse and dated 6/7/2022. Review indicated the patient’s medication included, but was not limited to, clopidogrel (a medication which thins the blood increasing the risk of bleeding). Review of an agency document titled “Nursing Visit Record” signed by the registered nurse and dated 6/7/2022, indicated the patient had a wound to the sacrum (lower back above the buttocks) and a wound to the right great toe. Review of an agency document titled “Home Health Plan of Care [and] Certification” for certification period 5/18/2022 – 7/16/2022 indicated the patient was to receive home health aide services 10 hours a day, 7 days a week. Review of an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 5/18/2022, failed to evidence the home health aide care plan was updated to include bleeding precautions and the patient’s wounds. Review indicated the home health aide frequency was 12 hours on Mondays and Thursdays and 10 hours on Sundays, Tuesdays, Wednesdays, Fridays, and Saturdays. Review failed to evidence the home health aide was directed to the frequency of home health aide services as ordered in the plan of care. During an interview on 7/1/2022, at 1:25 PM, the clinical manager indicated the home health aide care plan should have been updated to include bleeding precautions and the patient’s wounds. During an interview on 7/6/2022, at 10:29 AM, the administrator indicated the frequency on the home health aide care plan should match the frequency directed in the plan of care. 3. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Verbal Orders” electronically signed by the registered nurse and dated 4/28/2022. This document stated, “… the patient has been exhibiting behaviors that could be considered dangerous; yelling, screaming, taking handful of pills unscheduled, chasing staff in her wheelchair, grabbing staff by the wrist, throwing objects in her room, leaving house unaccompanied … This is a safety issue to patient as well as home health aide and family….” Review of an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 5/26/2022, failed to evidence directions to the home health aide regarding the patient’s behaviors. Under subtitled area “Transportation” a box was evidenced next to “Prevent Wandering” which was not checked. During an interview with the administrator on 7/1/2022, at 3:45 PM, the administrator indicated the registered nurse should have provided the home health aide direction on the home health aide care plan regarding the patient’s behaviors. The administrator indicated the home health aide should have been instructed to notify the office with any patient behaviors and to keep the patient calm. 410 IAC 17-14-1(m)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aides provided care as directed in the home health aide care plan in 2 of 3 active clinical records reviewed with home health aide services. (#2, 3) The findings include: 1. Review of an undated agency policy obtained 7/8/2022, titled “Home Health Aides” stated “… Follow aide assignment sheet of each assigned patient/client ….” 2. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 5/26/2022. Review indicated the home health aide was to provide oral care at every visit. Review of agency documents titled “Medicaid” and identified by the clinical manager to be home health aide notes indicated the home health aide did not provide oral care on 6/6/2022, 6/7/2022 and 6/9/2022 as directed in the home health aide care plan. During an interview on 7/1/2022, at 3:45 PM, the administrator indicated oral care should have been provided at every visit. 3. Clinical record review on 7/1/2022, for patient #3, start of care 3/17/2022, evidenced an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 5/16/2022. Review indicated the home health aide was to provide oral care and a sponge bath at every visit. Review of agency documents titled “Medicaid” and identified by the clinical manager to be home health aide notes indicated the home health aide did not provide oral care as directed in the home health aide care plan on 5/16/2022, 5/18/2022, 5/20/2022, 6/6/2022, 6/9/2022, 6/20/2022, and 6/22/2022. Review indicated the home health aide did not provide a sponge bath as directed by the home health aide care plan on 5/16/2022, 5/18/2022, 5/20/2022, 6/6/2022, 6/9/2022, 6/20/2022, and 6/22/2022. During an interview on 7/1/2022, at 3:41 PM, the administrator indicated tasks should be completed by the home health aide as directed on the care plan.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health aide failed to report changes in the patient’s condition to a registered nurse or other appropriate skilled professional in 2 of 3 active clinical records reviewed with home health aide services. (#1, 2) The findings include: 1. Review of an undated agency policy obtained 7/8/2022, titled “Home Health Aide Visit Protocol” stated, “… The aide … informs the home health care registered nurse of any pertinent observation ….” 2. Clinical record review on 6/29/2022, for patient #1, start of care 6/3/2019, evidenced an agency document titled “Aide Plan of Care, completed by the registered nurse and with an effective date of 5/18/2022. Review indicated the home health aide was to notify the case manager of a diastolic blood pressure (the pressure against the arteries when the heart is at rest and indicated by the bottom number in a blood pressure reading) less than 60. Review of an agency document titled “Medicaid” and identified by the clinical manager to be a home health aide note, indicated the patient’s diastolic blood pressure was 59. Review failed to indicate the home health aide notified the case manager of the diastolic blood pressure. During an interview on 7/1/2022, at 12:46 PM, the clinical manager indicated the home health aide did not report the blood pressure and should have reported it right away. 3. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 3/19/2022. Review indicated the home health aide was to notify the case manager of a temperature greater than 100.2 degrees Fahrenheit. Review of agency documents titled “Medicaid” and identified by the clinical manager to be home health aide notes, indicated the home health aide documented the patient had a temperature of 101.8 degrees Fahrenheit on 5/10/2022. The document stated “…Client temperature high because she was sitting in the sun….” Review failed to evidence the home health aide notified the case manager of the patient’s temperature. Review of document dated 5/12/2022 stated, “… Client very agitated….” Review failed to evidence the home health notified the case manager of the patient’s agitation. During an interview on 7/1/2022, at 3:45 PM, the administrator indicated the home health aide should have notified the registered nurse of the agitation and high temperature.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide (HHA) was supervised to ensure the aides furnished care that followed the patient’s plan of care in 2 of 3 active clinical records reviewed with home health aide services. (#2, 3) The findings include: 1. Review of an undated agency policy obtained 7/8/2022, titled “Home Health Aide Supervisory Visits” stated, “… The Registered Nurse will do the following: … Personal care given according to Plan of Care ….” 2. Clinical record review on 6/29/2022, for patient #2, start of care 6/11/2022, evidenced an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 5/26/2022. Review indicated the home health aide was to provide oral care at every visit. Review of agency documents titled “Medicaid” and identified by the clinical manager to be home health aide notes indicated the home health aide did not provide oral care on 6/6/2022, 6/7/2022 and 6/9/2022 as directed in the home health aide care plan. Review of an agency document titled “Supervisory Visit Note” signed by the clinical manager and dated 6/12/2022, indicated the home health aide provided care per the aide care plan. Review failed to evidence the registered nurse provided home health aide supervision to ensure the home health aides followed the aide care plan as directed. 3. Clinical record review on 7/1/2022, for patient #3, start of care 3/17/2022, evidenced an agency document titled “Aide Plan of Care” completed by the registered nurse and with an effective date of 5/16/2022. Review indicated the home health aide was to provide oral care and a sponge bath at every visit. Review of agency documents titled “Medicaid” and identified by the clinical manager to be home health aide notes indicated the home health aide did not provide oral care as directed in the home health aide care plan on 5/16/2022, 5/18/2022, 5/20/2022, 6/6/2022, 6/9/2022, 6/20/2022, and 6/22/2022. Review indicated the home health aide did not provide a sponge bath as directed by the home health aide care plan on 5/16/2022, 5/18/2022, 5/20/2022, 6/6/2022, 6/9/2022, 6/20/2022, and 6/22/2022. Review of agency documents titled “Supervisory Visit Note” signed by the clinical manager and dated 6/6/2022 and 6/20/2022, indicated the home health aide provided care per the aide care plan. Review failed to evidence the registered nurse provided home health aide supervision to ensure the home health aides followed the aide care plan as directed. 4. During an interview on 7/1/2022, at 3:42 PM, the administrator indicated the nurse should not mark the aide was completing care as directed in the aide care plan if the aide was not following the care plan. 410 IAC 17-14-1(n)