Every finding on record at Amedisys Sp-In LLC

See E0000

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 ensure a table top exercise or community based exercise was performed for field staff for the year of 2020 for 1 of 1 emergency preparedness review. Findings include: A November 2018 job description policy titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Director of Operations Job Duties ... 14. Assists in the orientation, training, and education ..." A review of the agency Emergency Preparedness binder on 10/6/2021 at 9:00 a.m. failed to evidence any table top or community based exercises for agency field staff. During an interview on 10/6/2021 at 10:00 a.m. the Administrator was asked if the agency conducted any emergency tabletop exercises or community based exercises with field staff. The Administrator indicated the agency did not perform any emergency preparedness exercises for 2020, but did complete a fire drill for office staff in 2021.

This visit was for two Federal and State Licensure complaint investigations of a home health agency. Fully Extended Survey was announced October 5, 2021 at 4:00 p.m. Complaint 31903: Substantiated, federal deficiencies related to the allegation were cited. Complaint 31978: Substantiated, federal deficiencies related to the allegation were cited. Survey Dates: October 4, 5, and 6, of 2021 Facility Number: 004926 Unduplicated Census last 12 months: 832 Total Active Patients Bloomington parent: 156 Total Active Patients Terre Haute branch: 390 Total Active Patient Indianapolis branch: 1 Amedisys Home Health is precluded from conducting a home health aide training or competency evaluation program for a period of two years starting October 6, 2021, to October 5, 2023, for being out of compliance with Conditions of Participation 484.105 Organization and Administration of Services and 42 CFR 484.75 Skilled Professional Services. These deficiencies reflect State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State findings. QR completed 10/26/2021 A4 An IDR was conducted on 12/16/21 and a final determination meeting was conducted on 1/27/2022. No changes will be made to the deficiencies cited at G940 however, the Deficient Practice Statement will be modified at G942, and G942 is modified.

OASIS privacy notice CFR(s): 484.50(a)(1)(iii) (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. This ELEMENT is not met as evidenced by: Based on record review, observation, and interview, the agency failed to indicate an OASIS (Outcome and Assessment Information Set) privacy notice was provided to patients upon initial visit for 18 of 18 records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18) which had the potential to affect all patients served by the home health agency. Findings included: A revised 6/24/2021 policy titled Patient Rights and Responsibilities was provided by the Clinical Manager (CM) on 10/5/21 at 8:25 a.m. The policy indicated, but was not limited to, "PURPOSE: The agency recognizes, respects, and promotes the rights of each individual patient …”2. The “Patient Acknowledgements and Consents” form provided by the agency upon admission to each patient did not include OASIS Privacy Rights written or verbal notice within it. All 18 patient records reviewed and 6 home visit observations completed did not show understanding and receipt of this form. An interview was conducted with the Clinical Manager (CM) on 10/5/2021 at 4:45 p.m. The CM indicated it should be on the Patient Acknowledgements and Consents form that is signed by the patient and kept in the admission binder showing it was received.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide written notice of services to be provided for 2 of 6 home visits. (Patient 4 & 11) Findings include: 1. A 6/24/21 policy titled Patient Rights and Responsibilities was provided by Clinical Manager C on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "Purpose: ... To clearly state the "Rights and Responsibilities" of the patient and to make a written document available for review by patient, caregiver, and staff ... (7) Be advised of orally and in writing: (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federal-funded or federal aid program known to the HHA, the HHA regarding treatment or care that is (or fails to be) (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided ... (8) Receive proper written notice, in advance of a specific service being furnished ..." 2. During a home visit on 10/4/2021 at 2:45 p.m. patient 4's admit packet contained a blank Patient Acknowledgements and Consents form. At that time, LPH H confirmed he/she has nothing to do with ensuring the patient had signed Consents in the home. Patient 4 was unable to provide additional information as to why the original and carbon copy were not filled out. The agency failed to ensure patient 4 was provided a copy of the written notice of services. 3. During a home visit on 10/5/2021 at 1:20 p.m. patient 11's admit packet contained a blank Patient Acknowledgement and Consents from. At that time, PT (physical therapist) M confirmed the forms were left blank. PT M indicated the were in the electronic medical record. The agency failed to ensure patient 11 was provided a copy of the written notice of services. 4. During an interview on 10/4/2021 at 4:30 p.m. the Administrator confirmed the patient should have had a signed written copy of the Patient Acknowledgements and Consent in the home.

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 all medications and treatments were on the plan of care for 2 of 6 home visit observations. (Patient 4 & 11) Findings include: 1. A 9/17/21 policy titled Supervision of the Plan of Care was provided by Clinical Manager C on 10/5/2021 at 8:15 a.m. The policy indicated, but was not limited to, "6. The current 485 will include: ... K. ... Medications and Treatment." 2. An 8/8/2017 signed Licensed Practical Nurse job description was provided by Office Manager E on 10/6/2021 at 3:00 p.m. The job description indicated, but was not limited to, "1. Verifies the plan of care and any verbal orders prior to each visit ... 3. Reviews all medications for each patient each visit and performs a medication reconciliation at each visit ..." 3. During entrance conference on 10/4/2021 at 10:10 a.m. Clinical Manager C indicated writing an addendum order was the agency's process for making corrections in the clinical record. Clinical Manager C indicated the clinician would write an order or refer to the physician if the patient reports a new medication or new medication was found in the home. Clinical Manager C indicated medication reconciliation should be done at every visit. 4. During a home visit on 10/4/2021 at 2:45 p.m. LPN H asked patient 4 if there were any changes in his/her medications. Patient 4 indicated he/she only takes Cinnamon and a multi vitamin. LPH H reviewed patient 4's medication on the agency's electronic tablet and asked about Hydrocodone (pain medication) and Lasix (medication for swelling). Patient 4 indicated Lasix was long gone and has a few Hydrocodone left. LPH H did not look at the individual medication bottles during the home visit and indicated he/she would make the changes. LPN H did not ask patient 4 if the physician discontinued the Lasix and added the Cinnamon or if patient 4 decided to stop taking the Lasix. No medication list from the agency was found in the home. The agency failed to include all medications on the Plan of Care. 5. The clinical record for patient 4, SOC date 7/16/2021, for the certification period 9/14/2021 to 11/12/2021, was reviewed on 10/4/2021 and indicated the following: The Plan of Care included a Client Medication Report which indicated patient 4 was receiving Furosemide (generic for Lasix) 20 mg daily by mouth, Hydrocodone 5 mg-Acetaminophen 325 mg every 6 hours by mouth, and Multivitamin one tablet daily by mouth. All medications indicated a start date of 7/25/2021. The Client Medication Report was last reviewed by an RN on 9/10/2021. The agency failed to revise the plan of care to accurately reflect the medications patient 4 was taking. 6. During a home visit on 10/5/2021 at 1:20 p.m. PT (physical therapist) M reviewed patient 11's medications. Patient 11 confirmed he/she was taking Zrytec (sinus medication) in an unlabeled bottle, Vitamin D 2,000 units (bone supplement), Vitamin B-12 (red blood cell supplement), Albuterol 200 doses puffs (asthma medication), and Albuterol solution (breathing medication). PT M confirmed the medications were not on the Plan of Care. PT M was asked why the admitting nurse did not include the medication on the Plan of Care. PT M was not sure, but thought the medications were locked up in a box on the initial visit. The agency failed to include all medications and treatments on the Plan of Care. 7. The clinical record for patient 11, SOC date 10/2/2021, for the certification period 12/2/2021 to 11/30/2021, was reviewed on 10/5/2021 and indicated the following: The Plan of Care for patient 11 did not include Zrytec, Vitamin D, Vitamin B-12, Albuterol puffs, and Albuterol solution. The agency failed to include all medications and treatments on the Plan of Care. 8. During an interview on 10/4/2021 at 4:30 p.m. Clinical Manger C indicated the expectation was for the clinician to look at the medication bottles during the home visit and verify the correct medication. Clinical Manager C indicated all medications should be included on the Plan of Care at the initial home visit. 17-13-1(a)(1)(B) 17-13-1(a)(1)(D)(ix)(xiii)

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to follow physician orders for 1 of 2 wound care observations. (Patient 4) Findings include: An 8/8/2017 signed Licensed Practical Nurse job description was provided by Office Manager E on 10/6/2021 at 3:00 p.m. The job description indicated, but was not limited to, "Reports to: RN Case Manager/Clinical Manager ... 1. Verifies the plan of care and any verbal orders prior to each visit and provides skilled nursing care to the patient according to the physician's orders and as directed by the Registered Nurse in accordance with care center policies." Reviewed the clinical record for patient 4 on 10/4/2021 at 1:02 p.m., SOC (start of care) date 7/16/2021, for the certification period 9/14/2021 to 11/12/2021, with orders for "HHC to wash legs and feet well every visit. To left medial lower leg, right medial leg, and right posterior leg. 125% Dakins soak. Allow to sit on wound for 10 minutes and then rinse away with normal saline cleanse both legs and feet daily with Hibiclens, use wash cloth with warm water to dry skin areas, scrub both legs, especially dry areas to get debris off. Moisturize with non-alcohol- based product - use coconut oil or Vaseline. Moisturize after washing the legs. apply Silver Ag to the wound bed. Cover with ABD pad. Secure with Kerlix roll gauze with tape secure with tubigrip F [compression sleeve for swelling]. Elevate legs above the level of the heart when sitting change dressing 3 times per week SN to change during SN visits and wound center to change other days." The clinical record for patient 4 indicated an addendum wound order dated 9/15/2021 at 3:18 p.m. The order indicated "cleansed wound with wound cleanser then patted dry with gauze. Dakin's solution applied to gauze and placed on wound bed for 10 minutes then rinsed away with wound cleanser and patted dry. Vaseline applied to the healthy skin and silver alginate cut to fit wound bed then covered with ABD and secured with Kerlix and tape. Tubigrip F stockette placed over dressing" The agency failed to indicate an anatomical location of wounds on the order and failed to indicate if Silver Ag was to be applied to all wounds. During a home visit on 10/5/2021 at 2:45 p.m. LPN H was observed applying Silver Ag (antimicrobial dressing) to two wounds on patient 4's lower medial and posterior leg and one wound on left lower leg. LPN H then applied ABD pads to both lower legs, secured with silk tape and applied clean tubigrip F stockettes to both lower legs. LPN H failed to adhere / follow physician orders and apply Vaseline to healthy skin and failed to apply Kerlix. During an interview on 10/5/2021 at 4:30 p.m. Clinical Manager C was unable to provide any additional information as to why the LPN did not follow physician orders. 17-14-1(a)(1)(H)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to update the physician to any changes in the patient's condition for 1 of 2 patients from the complaint log reviewed. (Patient 1) A revised policy dated 09/2021 titled Patient Assessment/Reassessment was provided by the Alternate Administrator on 10/04/2021 at 8:45 a.m. The policy indicated but was not limited to, "20. The patient's primary physician will be notified of changes/updates in the patient's condition." A revised policy date 12/04/2021 titled Laboratory Values Reporting was provided by non-employee B, Regional Director of Operations, on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, “1. Clinicians receiving a critical laboratory value from reference laboratory will report the critical value to the physician of record within one hour of receipt. 2. The clinician will notify the physician of record with the critical laboratory value by telephone, pager, or as directed by the physician. 3. The clinician … will also document confirmation received … 5. The clinician will document the interaction on a clinical note to be filed in the medical record. 6. The agency must assess critical lab value and the responsiveness of the physician … Examples of efforts to improve the timeliness of response by the physician include repeated paging, repeated voicemails, and repeated faxes to the physician until a response is obtained. All attempts made should be documented by the agency clinician.” The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Patient Information Report" dated 09/17/2021 signed by employee G indicated the following, “Time of Call: 0730 Name of Caller (Relationship to Patient): LabCorp … Purpose of Call: Calling with critical value …” Employee G failed to notify patient 1’s critical lab value within 1 hour. A document titled "Patient Information Report" dated 09/17/2021 signed by employee T at 11:42 a.m. indicated the following, “Received call from LabCorp of critical lab. Hgb [an iron-rich protein found in red blood cells that is primarily responsible for carrying oxygen from your lungs to the rest of the cells in the tissues and organs of your body. Normal values for a female is 12.0 to 15.5.] of 5.8. Lab result is called to … at Dr. … office. Awaiting further instruction …” A document titled "Patient Information Report" dated 09/19/2021 signed by employee U at 4:42 p.m. indicated the following, “Received phone call from … at Dr. … 9/17/2021 @ [at] 1438 [2:38 p.m.]. Wanting patient taken to ED [emergency department] for eval and treatment due to low hgb.” A document titled "Patient Information Report" dated 09/21/2021 signed by employee V at 11:33 a.m. indicated the following, “Admitted to [hospital] 9/19 … DX [Diagnosis]: GI [Gastrointestinal] Bleed. During an interview on 10/06/2021 at 3:55 p.m. the administrator stated employee G failed to follow policy and notify the physician of the critical value within 1 hour.17-13-1(d)

Coordination of Care CFR(s): 484.60(d) Standard: Coordination of care. The HHA must: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure coordination of care occurred between the patient, caregiver, and physician for 1 of 2 patients from the complaint log reviewed. (Patient 1) 1. A revised policy dated 09/2021 titled Patient Assessment/Reassessment was provided by the Alternate Administrator on 10/04/2021 at 8:45 a.m. The policy indicated but was not limited to, "20. The patient's primary physician will be notified of changes/updates in the patient's condition." 2. A revised policy dated 12/04/2021 titled Laboratory Values Reporting was provided by non-employee B, Regional Director of Operations, on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, "1. Clinicians receiving a critical laboratory value from reference laboratory will report the critical value to the physician of record within one hour of receipt. 2. The clinician will notify the physician of record with the critical laboratory value by telephone, pager, or as directed by the physician. 3. The clinician … will also document confirmation received … 5. The clinician will document the interaction on a clinical note to be filed in the medical record. 6. The agency must assess critical lab value and the responsiveness of the physician … Examples of efforts to improve the timeliness of response by the physician include repeated paging, repeated voicemails, and repeated faxes to the physician until a response is obtained. All attempts made should be documented by the agency clinician." 3. A revised policy dated 04/29/2021 titled On-Call/On-Call Book Format was provided by non-employee B on 10/04/2021 at 2:33 p.m. The document indicated but was not limited to, “Procedure … 3. After business hours and on weekends and holidays, coverage is available twenty-four (24) hours a day … c. The on-call clinician should call the patient or caregiver as soon as possible but at least within 15 minutes. d. The on-call clinician responding to after-hours phone calls is responsible for documenting coordination of care activities in response to calls on a Care Coordination Note …” 4. A 04/2019 policy titled Coordination of Care was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, “11. In the event an ordered service cannot be performed, the physician shall be notified, and new orders obtained as indicated. The patient will be referred to another provider accordingly. 5. The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Client Coordination Notes Report" dated 09/08/2021 signed by employee T indicated the following: “Patient has had increased fatigue as well as confusion … had low bp [blood pressure] this a.m. … caregiver has also requested urinalysis and has been unable to obtain specimen … daughter reports patient is incontinent most of the time and has foul smelling urine.” A document titled "Client Coordination Notes Report" dated 09/09/2021 signed by employee V indicated the following: “Spoke to … at Dr. … office … order for UA [urinalysis] … explained … we could send a nurse out for an eval and to collect the urine, but would not be until at least Monday [5 days later] due to clinicians on quarantine … do they want patient to wait … will have someone from office call HHC [home healthcare] back. A document titled "Client Coordination Notes Report" dated 09/14/2021 signed by employee T indicated the following: “Increased fatigue and overall decline. Urinalysis performed via straight cath [catheter] due [to] general weakness and ams [altered mental status]. A document titled "Patient Information Report" dated 09/16/2021 signed by employee G indicated the following, "Time of Call: 1854 [6:54 p.m.] 9.15.21 Name of Caller: … Family Member … Purpose of call … calling to speak with charge nurse or admin for complaint Action taken: Instructed to call back on Thursday during business hours to speak with management …” A document titled "Patient Information Report" dated 09/16/2021 signed by employee S at 11:34 a.m. indicated the following, "patients son reporting patient has increased edema in hands and feet as well as abdominal distention” A document titled "Patient Information Report" dated 09/17/2021 signed by employee G indicated the following, "Time of Call: 0730 Name of Caller (Relationship to Patient): LabCorp … Purpose of Call: Calling with critical value …" Employee G failed to notify patient 1's critical lab value within 1 hour. A document titled "Patient Information Report" dated 09/17/2021 signed by employee T at 11:42 a.m. indicated the following, "Received call from LabCorp of critical lab. Hgb [an iron-rich protein found in red blood cells that is primarily responsible for carrying oxygen from your lungs to the rest of the cells in the tissues and organs of your body. Normal values for a female is 12.0 to 15.5.] of 5.8. Lab result is called to … at Dr. … office. Awaiting further instruction …" A document titled "Patient Information Report" dated 09/19/2021 signed by employee U at 4:42 p.m. indicated the following, "Received phone call from … at Dr. … 9/17/2021 @ [at] 1438 [2:38 p.m.]. Wanting patient taken to ED [emergency department] for eval and treatment due to low hgb ... at 1500 [3:00 p.m.] Received second phone call from ... at Dr. ... office stating daughter called, demanding direct admit, which Dr. ... is unable to do ... unsure if patient will be taken to ED." A document titled "Patient Information Report" dated 09/21/2021 signed by employee V at 11:33 a.m. indicated the following, "Admitted to [hospital] 9/19 … DX [Diagnosis]: GI [Gastrointestinal] Bleed. The clinical record failed to evidence follow up by the agency to determine physician approved of a five-day in delay in obtaining a urinalysis and if the patient had been taken to the emergency room as directed by the physician after the agency received a call from the physician's office expressing concern. 6. During an interview on 10/06/2021 at 3:55 p.m. the administrator stated employee G failed to follow policy and notify the physician of the critical value within 1 hour. When asked why employee G did not send a nurse to assess the patient on 9/16/2021 when patient 1’s son called to report a change in condition and the administrator stated employee G did call an on-call nurse and they never responded. When asked if any further attempts were made or if their policy required more effort be made the administrator stated yes employee G should have made more attempts and she failed to do so.

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 agency failed to ensure staff were following acceptable standards of practice by actively taking their temperatures and documenting absence of illness or signs/symptoms of Covid-19 for 3 of 3 survey days; and failed to follow agency policy on hand hygiene for 1 of 2 wound care observations. (Patient 4) Findings include: 1. A policy titled Exposure to Coronavirus (Covid-19): Disease Response & Management was provided by the Clinical Manager on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "... follow the recommendation of the CDC to Covid-19 exposure and disease ... J. ... f. Visitors: ... ii. Before entering the care center, ALL visitors to the care center MUST wear a face covering/mask that covers nose and mouth both, check their temperature (before entry) and complete the COVID screening questionnaire." 2. A 6/24/21 policy titled Hand Hygiene was provided by Clinical Manager C on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "4. Perform hand hygiene as follows: a. Before having direct contact with patients b. Before donning gloves c. Before performing a procedure ... d. After contact with a patient's intact skin e. After contact with body fluids or excretions, mucous membranes, nonintact skin, and wound dressings f. When moving from a contaminated body site to a clean body site during patient care g. After contact with inanimate objects (e.g. medical equipment) in the immediate vicinity of the patient h. After removing gloves ... 10. Remove gloves after caring for a patient." 3. On 10/4/2021, 10/5/2021, 10/6/2021 the agency failed to screen state surveyors for Covid-19 by checking temperatures before entering agency and failed to complete the Covid screening questionnaire as indicated by agency policy. 4. During an interview on 10/6/2021 at 4:30 p.m. the Administrator and Clinical Manager confirmed they should have screened the surveyors for Covid-19 (contagious disease caused by a virus) upon entering the agency. 5. During a home visit on 10/5/2021 at 2:45 p.m. LPN (Licensed Practical Nurse) H was observed providing wound care for patient 4. LPN H donned gloves and proceeded to remove soiled tubigrip (compression sleeve) for both legs. LPN H went into his/her supply bag with soiled gloves on to obtain a scissors. LPN H failed to remove gloves and perform hand hygiene prior to entering the supply bag. LPN H proceeded to cut off soiled roll gauze, taped soiled ABD (high absorbent abdominal) pad and removed 2 pieces of Silver Ag (antimicrobial dressing) on right medial lower leg and one piece of Silver Ag to posterior right lower leg. LPN H went into patient 4's supply box with soiled gloves on to obtain wound cleanser. LPN H failed to remove gloves and perform hand hygiene after contact with soiled dressings. LPN H sprayed wound cleanser onto right posterior leg while wearing soiled gloves and then reached into patient 4's 4 x 4 gauze supplies and proceeded to clean the wound to left lower leg. LPN H reached into patient 4's supply box to obtain Dakins solution (bleach to kill infections) and clean 4 x 4 gauze with soiled gloves. LPN H failed to remove gloves and perform hand hygiene when moving from a contaminated body site to a clean area as indicated by agency policy. LPN H cleaned 2 wounds on right lower leg and removed gloves. LPN H performed hand hygiene, applied gloves, and sprayed wound cleanser onto both legs to remove Dakins solution and proceeded to measure all 3 wounds using one paper measuring tool. LPN H then cleaned around left wound with Hibiclens (solution that kills germs) then reached back into patient 4's clean supply 4 x 4 gauze bag for more gauze to wipe off Hibiclens then removed gloves. LPN H failed to remove gloves and perform hand hygiene when moving from a contaminated body site to a clean area as indicated by agency policy. 6. During an interview on 10/5/2021 at 4:30 p.m. Clinical Manger C confirmed hand hygiene should have been performed regarding patient 4's home visit. 17-12-1(m)

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure all skilled professionals who provided patient care directly or indirectly ensured interdisciplinary assessment of the patient (See G706); failed to ensure all services were provided as ordered (See G710); failed to ensure all communication was documented in the clinical record (See G716); and failed to ensure adequate communication with all physicians within the policies guidelines and when the patient's condition warranted (See G718). These failures resulted in an adverse outcome for 1 of 2 patients on the complaint log reviewed (Patient 1) with the potential to affect all of the agency’s patients. (Patient 1) The cumulative effect of this systemic problem resulted in the agency being out of compliance with §484.75 Condition of participation: Skilled professional services.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview the agency staff failed to coordinate an interdisciplinary assessment of the patient for 1 of 2 patients from the complaint log reviewed. (Patient 1) 1. A revised policy dated 09/17/2021 titled Physician Orders was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, "All patient care orders from all physicians, including verbal orders, must be recorded/integrated in the plan of care to assure coordination of all services and interventions provided." 2. A 04/2019 policy titled Coordination of Care was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, "Integrate services whether provided directly or under arrangement ... coordinate care delivery to meet the patient's needs. 3. A revised policy dated 09/2021 titled Patient Assessment/Reassessment was provided by the Alternate Administrator on 10/04/2021 at 8:45 a.m. The policy indicated but was not limited to, "20. The patient's primary physician will be notified of changes/updates in the patient's condition." 4. A revised policy date 12/04/2021 titled Laboratory Values Reporting was provided by non-employee B, Regional Director of Operations, on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, "1. Clinicians receiving a critical laboratory value from reference laboratory will report the critical value to the physician of record within one hour of receipt. 2. The clinician will notify the physician of record with the critical laboratory value by telephone, pager, or as directed by the physician. 3. The clinician ... will also document confirmation received ... 5. The clinician will document the interaction on a clinical note to be filed in the medical record. 6. The agency must assess critical lab value and the responsiveness of the physician ... Examples of efforts to improve the timeliness of response by the physician include repeated paging, repeated voicemails, and repeated faxes to the physician until a response is obtained. All attempts made should be documented by the agency clinician." 5. The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Client Coordination Notes Report" dated 09/08/2021 signed by employee T indicated the following: "Patient has had increased fatigue as well as confusion ... had low bp [blood pressure] this a.m. ... caregiver has also requested urinalysis and has been unable to obtain specimen ... daughter reports patient is incontinent most of the time and has foul smelling urine." A document titled "Client Coordination Notes Report" dated 09/09/2021 signed by employee V indicated the following: "Spoke to ... at Dr. ... office ... order for UA [urinalysis] ... explained ... we could send a nurse out for an eval and to collect the urine, but would not be until at least Monday [5 days later] due to clinicians on quarantine ... do they want patient to wait ... will have someone from office call HHC [home healthcare] back." A document titled "Client Coordination Notes Report" dated 09/14/2021 signed by employee T indicated the following: "Increased fatigue and overall decline. Urinalysis performed via straight cath [catheter] due [to] general weakness and ams [altered mental status]." A document titled "Patient Information Report" dated 09/16/2021 signed by employee G indicated the following, "Time of Call: 1854 [6:54 p.m.] 9.15.21 Name of Caller: ... Family Member ... Purpose of call ... calling to speak with charge nurse or admin for complaint Action taken: Instructed to call back on Thursday during business hours to speak with management ..." A document titled "Patient Information Report" dated 09/16/2021 signed by employee S at 11:34 a.m. indicated the following, "patients son reporting patient has increased edema in hands and feet as well as abdominal distention." A document titled "Patient Information Report" dated 09/17/2021 signed by employee G indicated the following, "Time of Call: 0730 Name of Caller (Relationship to Patient): LabCorp ... Purpose of Call: Calling with critical value ..." Employee G failed to notify patient 1's critical lab value within 1 hour. A document titled "Patient Information Report" dated 09/17/2021 signed by employee T at 11:42 a.m. indicated the following, "Received call from LabCorp of critical lab. Hgb [an iron-rich protein found in red blood cells that is primarily responsible for carrying oxygen from your lungs to the rest of the cells in the tissues and organs of your body. Normal values for a female is 12.0 to 15.5.] of 5.8. Lab result is called to ... at Dr. ... office. Awaiting further instruction ..." A document titled "Patient Information Report" dated 09/19/2021 signed by employee U at 4:42 p.m. indicated the following, "Received phone call from ... at Dr. ... 9/17/2021 @ [at] 1438 [2:38 p.m.]. Wanting patient taken to ED [emergency department] for eval and treatment due to low hgb ... at 1500 [3:00 p.m.] Received second phone call from ... at Dr. ... office stating daughter called, demanding direct admit, which Dr. ... is unable to do ... unsure if patient will be taken to ED." A document titled "Patient Information Report" dated 09/21/2021 signed by employee V at 11:33 a.m. indicated the following, "Admitted to [hospital] 9/19 ... DX [Diagnosis]: GI [Gastrointestinal] Bleed. A document titled "Preliminary Report" from the hospital patient 1 was admitted for admission dates 09/19/2021 to 09/22/2021 that indicated, but was not limited to, "Patient given 2 units PRBC [packed red blood cells] ... anemia related to acute GI bleed ... Urinary Tract Infection ... " During an interview on 10/06/2021, the administrator acknowledged that employee W, RN, failed to obtain UA as ordered, failed to document the reason for the 5-day lapse from when the UA was ordered, and the UA was obtained. Employee G, RN, failed to follow up when the on-call nurse failed to respond to dispatch when the family call after-hour line reporting the patient's condition was deteriorating. Employee G failed to follow policy and reach out to another on-call nurse or follow up with the patient and/or family when unable to dispatch an on-call nurse. Employee G failed to notify the physician within 1 hour when notification of a critical lab value for patient 1 was received per agency policy. Employee G failed to document any attempts to address critical value or reasons why it was not addressed. 4 hours after the first phone call related to the critical lab value employee T, RN, contacted the MD office and then failed to follow up or document any follow up related to the critical lab value. An additional 3 hours lapsed when Employee U, RN received a phone call notifying the home health agency the patient needed to go to the emergency room. An additional 20 minutes later employee U received a second phone call from the MD office expressing concerns that the patient was not going to the ED. Employee U failed to make any follow-up or document any follow-up on the status of the patient and if the patient made it to the ED. As a result of these failures, the patient subsequently was admitted to the hospital with an acute GI bleed and an active urinary tract infection. 2 days later employee V documented the patient had been admitted to the hospital for a GI bleed. The agency was made aware of the patient's deteriorating condition on 9/8/2021 and as a result of repeated failures on the skilled nurses' part, the patient was admitted on 9/19/2021. The hospital admission had the potential to be avoided if all the skilled professionals involved in the patient's care had followed policy and actively coordinated care. 17-12-2(g)

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview the skilled professional failed to provide all services ordered by the physician for 1 of 2 complaint records reviewed. (Patient 1); and failed to provide all wound care as ordered by the physician for 1 of 2 wound care observations. (Patient 4) 7. The clinical record for patient 4, SOC (start of care) date 7/16/2021 at 1:02 p.m., for the certification period 9/14/2021 to 11/12/2021, with orders for "HHC to wash legs and feet well every visit. To left medial lower leg, right medial leg, and right posterior leg. 125% Dakins soak. Allow to sit on wound for 10 minutes and then rinse away with normal saline cleanse both legs and feet daily with Hibiclens, use wash cloth with warm water to dry skin areas, scrub both legs, especially dry areas to get debris off. Moisturize with non-alcohol- based product - use coconut oil or Vaseline. Moisturize after washing the legs. apply Silver Ag to the wound bed. Cover with ABD pad. Secure with Kerlix roll gauze with tape secure with tubigrip F [compression sleeve for swelling]. Elevate legs above the level of the heart when sitting change dressing 3 times per week SN to change during SN visits and wound center to change other days." 8. The clinical record for patient 4 indicated an addendum wound order dated 9/15/2021 at 3:18 p.m. The order indicated "cleansed wound with count cleanser then patted dry with gauze. Dakin's solution applied to gauze and placed on wound bed for 10 minutes then rinsed away with wound cleanser and patted dry. Vaseline applied to the healthy skin and silver alginate cut to fit wound bed then covered with ABD and secured with Kerlix and tape. Tubigrip F stockette placed over dressing" 9. During a home visit on 10/5/2021 at 2:45 p.m. LPN H was observed applying Silver Ag (antimicrobial dressing) to two wounds on patient's 4 lower medial and posterior leg and one wound on left lower leg. LPN H then applied ABD pads to both lower legs, secured with silk tape and applied clean tubigrip F stockettes to both lower legs. LPN H failed to adhere / follow physician orders and apply Vaseline to healthy skin and failed to apply Kerlix. 10. During an interview on 10/5/2021 at 4:30 p.m. Clinical Manager C was unable to provide any additional information as to why the LPN did not follow physician orders. 1. A revised policy dated 09/17/2021 titled Physician Orders was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, “All patient care orders from all physicians, including verbal orders, must be recorded/integrated in the plan of care to assure coordination of all services and interventions provided.” 2. A 04/2019 policy titled Coordination of Care was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, “Integrate services whether provided directly or under arrangement … coordinate care delivery to meet the patient’s needs ... 3. A 04/2019 policy titled Coordination of Care was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, “11. In the event an ordered service cannot be performed, the physician shall be notified, and new orders obtained as indicated. The patient will be referred to another provider accordingly. 4. The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Client Coordination Notes Report" dated 09/08/2021 signed by employee T indicated the following: “Patient has had increased fatigue as well as confusion … had low bp [blood pressure] this a.m. … caregiver has also requested urinalysis and has been unable to obtain specimen … daughter reports patient is incontinent most of the time and has foul smelling urine.” A document titled "Client Coordination Notes Report" dated 09/09/2021 signed by employee V indicated the following: “Spoke to … at Dr. … office … order for UA [urinalysis] … explained … we could send a nurse out for an eval and to collect the urine, but would not be until at least Monday [5 days later] due to clinicians on quarantine … do they want patient to wait … will have someone from office call HHC [home healthcare] back. The clinical record failed to evidence any further communication with the physician related to delaying the physician’s order for a urinalysis related to the patient having increased fatigue and confusion. 5. During an interview on 10/06/2021 the administrator was asked why the urinalysis was not performed when ordered by the physician. The administrator stated they would have to look into it. 6. During an interview on 10/06/2021 the administrator stated she spoke to employee W, Registered Nurse, and employee W stated she spoke with the patient’s family, and they agreed to wait a week but it is not documented anywhere in the clinical record.

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 agency failed to ensure clinicians prepared accurate clinical notes for 1 of 2 wound care observations (Patient 4); and failed to document and follow agency policy on reporting critical lab values for 1 of 1 record reviewed with critical lab values. (Patient 1) 7. During a home visit on 10/5/2021 at 2:45 p.m. LPN H was observed measuring patient 4's right lateral lower leg wound 4 cm (centimeters) x 3 cm with a paper measuring tool then used the same tool to measure left lower leg wound 12 cm x 5 cm. LPN H used the same paper measuring tool to measure right posterior leg wound as 2.3 am x 2 cm. LPN H did not measure wound depth on any of the wounds. LPN H reached into patient supplies with soiled gloves on and opened Hibiclens bottle. LPN H indicated he/she could not remember the measurements. LPN H re-measured left lateral wound as 4 cm x 2.5 cm and right posterior lower leg wound as 2.5 cm x 1.5 cm. LPN H failed to measure depth of wounds. 8. A review of the Wound Assessment Tool Report dated 10/4/2021 at 3:59 p.m. indicated wound measurements for patient 4's right lateral leg wound as Length 4 cm x Width 1.5 cm x 0.1 cm depth, right posterior lower leg wound as 2 cm x 1.5 cm x 0.2 cm depth; and left medial lower leg wound as 12 cm x 5 cm x 0.2 cm depth. LPN H failed to accurately document the measurements taken at the home into patient 4's clinical record. A review of the Visit Note Report dated 10/4/2021 at 3:59 p.m. indicated PERRL was performed at patient 4's home visit. During patient 4's home visit LPN H did not complete PERRL (assessment of eyes with reaction to light). The Visit note did not accurately reflect the care provided at the home visit. 9. During an interview on 10/4/2021 at 4:30 p.m. Clinical Manager C was asked what his/her expectation was for measuring depth of wounds. Clinical Manager C indicated the clinicians should use a q-tip to measure wound depth and use a pen light to assess PERRL. Clinical Manager C was unable to provide any additional information regarding the accuracy of documentation. 17-14-1(a)(2)(B) A revised policy dated 09/17/2021 titled Physician Orders was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, “All patient care orders from all physicians, including verbal orders, must be recorded/integrated in the plan of care to assure coordination of all services and interventions.” A revised policy dated 04/29/2021 titled On-Call/On-Call Book Format was provided by non-employee B on 10/04/2021 at 2:33 p.m. The document indicated but was not limited to, “Procedure … 3. After business hours and on weekends and holidays, coverage is available twenty-four (24) hours a day … c. The on-call clinician should call the patient or caregiver as soon as possible but at least within 15 minutes. d. The on-call clinician responding to after-hours phone calls is responsible for documenting coordination of care activities in response to calls on a Care Coordination Note …” The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Client Coordination Notes Report" dated 09/08/2021 signed by employee T indicated the following: “Patient has had increased fatigue as well as confusion … had low bp [blood pressure] this a.m. … caregiver has also requested urinalysis and has been unable to obtain specimen … daughter reports patient is incontinent most of the time and has foul smelling urine.” A document titled "Client Coordination Notes Report" dated 09/09/2021 signed by employee V indicated the following: “Spoke to … at Dr. … office … order for UA [urinalysis] … explained … we could send a nurse out for an eval and to collect the urine, but would not be until at least Monday [5 days later] due to clinicians on quarantine … do they want patient to wait … will have someone from office call HHC [home healthcare] back. A document titled "Patient Information Report" dated 09/17/2021 signed by employee G indicated the following, “Time of Call: 0730 Name of Caller (Relationship to Patient): LabCorp … Purpose of Call: Calling with critical value …” Employee G failed to notify patient 1’s critical lab value within 1 hour. A document titled "Patient Information Report" dated 09/16/2021 signed by employee G indicated the following, "Time of Call: 1854 [6:54 p.m.] 9.15.21 Name of Caller: … Family Member … Purpose of call … calling to speak with charge nurse or admin for complaint Action taken: Instructed to call back on Thursday during business hours to speak with management …” During an interview on 10/06/2021 the administrator stated she spoke to employee W, Registered Nurse, and employee W stated she spoke with the patient’s family, and they agreed to wait a week but it is not documented anywhere in the clinical record. During an interview on 10/06/2021 with the administrator when asked why employee G did not send a nurse to assess the patient on 9/16/2021 when patient 1’s son called to report a change in condition and the administrator stated she spoke to employee G and the employee did call an on-call nurse and they never responded. When asked if any further attempts were made or if their policy required more effort be made the administrator stated yes employee G should have made more attempts and she failed to do so. The skilled professional failed to include documentation in the clinical record of attempts to reach an on-call nurse. During an interview on 10/06/2021 at 3:55 p.m. the administrator stated employee G failed to follow policy and notify the physician of the critical value within 1 hour. The administrator stated the employee attempted to call the Lab back to obtain what the critical value was and did not receive a response. The administrator stated employee G did not document in the clinical record an attempt to call the lab back.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nursing staff failed to maintain communication with the physician related to the patients' care for 1 of 2 patients from the complaint log reviewed. (Patient 1) 1. A revised policy dated 09/2021 titled Patient Assessment/Reassessment was provided by the Alternate Administrator on 10/04/2021 at 8:45 a.m. The policy indicated but was not limited to, "20. The patient's primary physician will be notified of changes/updates in the patient's condition." 2. A revised policy date 12/04/2021 titled Laboratory Values Reporting was provided by non-employee B, Regional Director of Operations, on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, "1. Clinicians receiving a critical laboratory value from reference laboratory will report the critical value to the physician of record within one hour of receipt. 2. The clinician will notify the physician of record with the critical laboratory value by telephone, pager, or as directed by the physician. 3. The clinician … will also document confirmation received … 5. The clinician will document the interaction on a clinical note to be filed in the medical record. 6. The agency must assess critical lab value and the responsiveness of the physician … Examples of efforts to improve the timeliness of response by the physician include repeated paging, repeated voicemails, and repeated faxes to the physician until a response is obtained. All attempts made should be documented by the agency clinician." 3. The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Client Coordination Notes Report" dated 09/09/2021 signed by employee V indicated the following: "Spoke to … at Dr. … office … order for UA [urinalysis] … explained … we could send a nurse out for an eval and to collect the urine, but would not be until at least Monday [5 days later] due to clinicians on quarantine … do they want patient to wait … will have someone from office call HHC [home healthcare] back." The clinical record failed to evidence any further communication with the physician related to delaying the physician's order for a urinalysis related to the patient having increased fatigue and confusion. A document titled "Patient Information Report" dated 09/17/2021 signed by employee G indicated the following, "Time of Call: 0730 Name of Caller (Relationship to Patient): LabCorp … Purpose of Call: Calling with critical value …" Employee G failed to notify patient 1's critical lab value within 1 hour. A document titled "Patient Information Report" dated 09/17/2021 signed by employee T at 11:42 a.m. indicated the following, "Received call from LabCorp of critical lab. Hgb [an iron-rich protein found in red blood cells that is primarily responsible for carrying oxygen from your lungs to the rest of the cells in the tissues and organs of your body. Normal values for a female is 12.0 to 15.5.] of 5.8. Lab result is called to … at Dr. … office. Awaiting further instruction …" A document titled "Patient Information Report" dated 09/19/2021 signed by employee U at 4:42 p.m. indicated the following, "Received phone call from … at Dr. … 9/17/2021 @ [at] 1438 [2:38 p.m.]. Wanting patient taken to ED [emergency department] for eval and treatment due to low hgb." A document titled "Patient Information Report" dated 09/21/2021 signed by employee V at 11:33 a.m. indicated the following, "Admitted to [hospital] 9/19 … DX [Diagnosis]: GI [Gastrointestinal] Bleed. 4. During an interview on 10/06/2021 at 3:55 p.m. the administrator stated employee G failed to follow policy and notify the physician of the critical value within 1 hour. 17-14-1(a)(1)(G)

Information to the state survey agency CFR(s): 484.100(a) Standard: The HHA also must disclose the following information to the state survey agency at the time of the HHA's initial request for certification, for each survey, and at the time of any change in ownership or management: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to notify the State agency of a change in management for 1 of 1 home health agency. Findings include: A November 2018 signed job description titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "When the Administrator is not available, a qualified, pre-designated person, who is authorized in writing by the Administrator and the governing body, assumes the same responsibilities and obligations as the Administrator." A review of the State database information indicated former employee U was the Alternate Administrator. During entrance conference on 10/4/2021 at 10:30 a.m. employee C indicated he/she was the Alternate Administrator. During entrance conference on 10/4/2021 at 10:10 a.m. the Administrator was asked to provide the appointment letter for the Alternate Administrator. On 10/4/2021 at 1:30 p.m. the Administrator provide a document dated September 21, 2021 that indicated employee C was replacing employee U as the Alternate Administrator signed by non-employee P, Regulatory Coordinator, from Baton Rouge, LA. Informed the Administrator that the document provided was not an appointment letter, but a notification to the State agency. The Administrator was asked who appointed employee C as Alternate Administrator and if there was a confirmation letter received from the State agency regarding the change to which he/she replied "I will find out." During an interview on 10/5/2021 at 9:55 a.m. the Administrator provided an appointment letter that was dated 3/22/2021, digitally signed by non-employee W, President of Home Health. The letter indicated "As of February 25, 2021, the Governing Body has appointed [name of employee C] R.N., as the Alternate Supervising Nurse of Amedisys Sp-IN, L.L.C. d/b/a Amedisys Home Health. (Bloomington). Notification has been made to the state of Indiana accordingly. Governing Body Representative: [non-employee W] Digitally signed by [non-employee W] ... Date 2021.03.22 ... President of Home Health" The Administrator indicated non-employee W was a Governing Body member at that time, but was no longer currently employed. A review of 3 Governing Body members lists that were provided by the Administrator did not indicate non-employee W was a past member of the Governing Body. At that time, a review of the State database did not indicate non-employee W was a past Governing Body member. The Administrator was not able to provide the confirmation letter from the State agency regarding management changes. The Administrator was asked why he/she did not submit the information to State instead of non-employee P from Louisiana, to which he/she did not answer. The parent agency failed to notify the State agency of management changes. 17-10-1(d)

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure agency accurately set forth in writing, its organizational structure, lines of authority, and services furnished (See G940); failed to ensure failed to have governing body meetings minutes specific for the home health agency and not for other entities (See G942); failed to ensure a direct relationship with the governing body was maintained (See G946): failed to provide overall direction and leadership of agency services, failed to ensure the agency met all rules and regulations for recertification, and failed ensure the responsibility for all day-to-day operations of the parent agency and branch locations (See G948); failed to ensure a pre-designated person authorized in writing by the Administrator and Governing Body was available to fulfill the role of administrator in the absence of the administrator (See G954); failed to ensure that patient needs were continually assessed (See G966); failed to ensure the lines of authority and professional and administrative control were clearly delineated in the agency's organizational structure (See G970); failed to ensure the parent agency provided direct support and administrative control of its branches (See G974): failed provide services in accordance with accepted professional standards of practice regarding wound measurements (See G984). The cumulative effect of this systemic problem resulted in the agency being out of compliance with §484.105 Condition of participation: Organization and administration of services. In regards to G940, based on record review and interview the agency failed to ensure agency accurately set forth in writing, its organizational structure, lines of authority, and services furnished for 1 of 1 home health agency. Findings include: A 6/24/21 policy titled Governing Body was provided by Clinical Manager C on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "The Governing Body assumes full legal authority and responsibility for the policies and procedures that govern the day-to-day operations of each home health agency owned by the direct and indirect operating subsidiaries of Amedisys, Inc. (such operating subsidiaries are collectively referred to herein as "Amedisys"). The Policy/Bylaws of the Governing Body outline the responsibilities and authority of the Governing Body. ... 4. ... a. The Governing Body will develop an organizational structure for each Amedisys home health agency: the Administrator/Director of Operations (DOO) (or regional DOO/Acting or Interim DOO, or person with a similar function) of each home health agency will follow a chain of command by reporting to a designated Area Vice President (AVP), who reports to a designated Vice President of Operations who reports to a designated Senior Vice President of Operations in communicating information to the Governing Body. ... c. State survey results for individual Amedisys agencies will be monitored by the Amedisys, Inc. Regulatory Services Department and reported to the Governing Body on an ongoing basis. ..." A November 2018 signed job description titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Responsible to ADOO (area director of operations) or Area Vice President of Operations ... Director of Operations Job Duties ... Assist Branch Directors in resolving patient and / or staff complaints ... investigating and documenting the event, and notifying the person lodging the complaint to resolve the issues." The agency failed to ensure the Administrator reported directly to the Governing Body. An undated job description titled Alternate Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Responsible to Area Vice President of Operations" The agency fails to ensure the Administrator reports to the Governing Body. Reviewed two organizational charts provided by Clinical Manager C on 10/4/2021 at 1:30 p.m. One chart indicated the Administrator reports to non-employee Area Vice President of Clinical Services C and the other chart indicates the Administrator reports to the Governing Body (no specific names listed). The agency failed to accurately set forth a clear organizational structure and lines of authority to manage the home health agency in order to meet the condition of participation for organization and administrative services. A review of the CMS 855 submitted to the State agency included one organizational chart that indicated the Administrator would report to the Area Vice President of Operations D, who was not a governing body member or an employee of the HHA. A review of the Indianapolis branch information submitted to the State agency titled Detailed Description of Hiring, Training, and Supervision for the Parent and Branch indicated, "II. Hiring ... Staffing Plan: The Branch is planning to hire the following full time members: Director of Operations, Office Manager, Registered Nurse, Physical Therapist, Occupational Therapist ..." The Indianapolis branch information that was submitted to the State agency indicated the Administrator will report to the Regional Administrator who reports to the Vice President and then to Corporate. The agency failed to ensure the Administrator directly reports to the Governing Body. 17-12-1(a)(1) 17-12-1(a)(2)

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review, the agency failed to ensure Governing Body meetings were specific to the agency and not that of other entities for 1 of 1 home health agency that affects all patients. Findings include: A review of the Governing Body meeting dated 3/8/2021 indicated data on staffing and QAPI (quality assessment performance improvement) included information for separate providers operating under a different license as follows: Fort Wayne Entity, Jeffersonville Entity, and Portage Entity. 17-12-1(b)

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator reported directly to the Governing Body without the use of intermediaries for 1 of 1 home health agency. Findings include: A 6/24/21 policy titled Governing Body was provided by Clinical Manager C on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "The Governing Body assumes full legal authority and responsibility for the policies and procedures that govern the day-to-day operations of each home health agency owned by the direct and indirect operating subsidiaries of Amedisys, Inc. (such operating subsidiaries are collectively referred to herein as "Amedisys"). The Policy/Bylaws of the Governing Body outline the responsibilities and authority of the Governing Body. ... 4. ... a. The Governing Body will develop an organizational structure for each Amedisys home health agency: the Administrator/Director of Operations (DOO) (or regional DOO/Acting or Interim DOO, or person with a similar function) of each home health agency will follow a chain of command by reporting to a designated Area Vice President (AVP), who reports to a designated Vice President of Operations who reports to a designated Senior Vice President of Operations in communicating information to the Governing Body. ... c. State survey results for individual Amedisys agencies will be monitored by the Amedisys, Inc. Regulatory Services Department and reported to the Governing Body on an ongoing basis. ..." The agency failed to ensure the Administrator reports to the Governing Body. A November 2018 signed job description titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Responsible to ADOO (area director of operations) or Area Vice President of Operations ... " The agency failed to ensure the Administrator reports to the Governing Body. An undated job description titled Alternate Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Responsible to Area Vice President of Operations" The agency failed to ensure the Administrator reports to the Governing Body. During entrance conference on 10/4/2021 at 10:10 a.m. the Administrator confirmed he/she was the Administrator/DOO (director of operations). The Administrator was asked who the members of the governing body were to which he/she replied "I will get you the list." On 10/4/2021 at 1:30 p.m. Clinical Manager C provided 2 organizational charts. Organizational chart #1 indicated the Administrator reported to non-employee Area Vice President D, non-employee Area Vice President of Clinical Services C, and indirectly reports to non-employee Vice President (BD) E. Organizational chart #2 indicated the Administrator reported to the Governing Body (no specific names listed). The agency failed to ensure a direct relationship between the administrator and members of the governing body. On 10/4/2021 at 3:52 p.m. the Administrator provided an undated list of the Governing Board Members' names, phone numbers, and addresses. The list of names did not indicate non-employee Area Vice President D, non-employee Area Vice President of Clinical Services C or non-employee Vice President (BD) E as members of the Governing Body. On 10/5/2021 at 10:30 a.m. the Administrator provided a second revision of an undated list of Governing Board Members' names, phone numbers, and addresses that were received from non-employee V, Regulatory Personnel in Louisiana. The list of names did not indicate non-employee Area Vice President D, non-employee Area Vice President of Clinical Services C or non-employee Vice President (BD) E as members of the Governing Body. The agency failed to ensure a direct relationship between the administrator and members of the governing body. On 10/5/2021 at 11:50 a.m. the Administrator provided a third revision dated August 1, 2021 of Governing Board Members' names, phone numbers, and addresses that were received from non-employee V, Regulatory Personnel in Louisiana. The list of names did not indicate non-employee Area Vice President D, non-employee Area Vice President of Clinical Services C or non-employee Vice President (BD) E as members of the Governing Body. The agency failed to ensure a direct relationship between the administrator and members of the governing body. During an interview on 10/5/2021 at 4:30 p.m. informed the Administrator there were concerns he/she was unable to identify any of the Governing Body members' names even though he/she reports to them. The Administrator indicated he/she reports to the Governing Body, but does not have one/one communication with them. 17-12-1(c)(2)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review, the administrator failed to provide overall direction and leadership of agency services, failed to ensure the agency met all rules and regulations for recertification, and failed ensure the responsibility for all day-to-day operations of the parent agency and branch locations for 1 of 1 home health agency. Findings include: The administrator failed to ensure the agency provided patients with a written notice of services. See Tag G0442 The administrator failed to ensure care and services were provided per the plan of care. See Tag G0572 The administrator failed to ensure all pertinent information was included in the plan of care. See Tag G0574 The administrator failed to ensure the physician was notified of a patient's allergy to a medication that was prescribed. See Tag G0590 The administrator failed to ensure the plan of care was updated/ revised to contain all pertinent information. See Tag 0G592 The administrator failed to ensure patients received a written notice of services provided. See Tag G0442 The administrator failed to ensure all medications and treatments were on the plan of care. See Tag G0574 The administrator failed to ensure staff were following acceptable standards of practice by actively taking their temperatures and documenting absence of illness or signs/symptoms of Covid-19 and failed to ensure clinicians followed agency policy on hand hygiene. See Tag G0682 The administrator failed to ensure clinicians prepared accurate clinical notes. See Tag G0716 The administrator failed to ensure the agency accurately set forth in writing, its organizational structure, lines of authority, and services furnished. See Tag G0940 The administrator failed to ensure policies were adopted by the agency only contained information of the home health agency and not that of other entities; and failed to ensure acknowledgement of consents were specific for the home health agency and not that of other entities for 1 of 1 home health agency that affect all patients. See Tag G0942 The administrator failed to ensure he/she reported directly to the Governing Body without the use of intermediaries. See Tag G0946 The administrator failed to ensure a qualified Alternate Administrator was authorized in writing by the Administrator and Governing Body. See Tag G0954 The administrator failed to ensure the lines of authority and professional and administrative control were clearly delineated in the agency's organizational structure. See Tag 0970 The administrator failed to ensure the parent agency failed provided direct support and administrative control of its branches. See Tag G0974 The administrator failed to ensure the agency provide services in accordance with accepted professional standards of practice regarding wound measurements. See Tag G0984 The administrator failed to ensure the agency documented education interventions as ordered on the plan of care. See 1014 The administrator failed to ensure all entries in the clinical record are accurate, clear, and complete. See 1024 The administrator failed to ensure the agency conducted a table top exercise to test their emergency plan. See Tag E0039. 17-12-1(b)(3) 17-12-1(c)(1)

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a qualified Alternate Administrator was authorized in writing by the Administrator and Governing Body; and failed to notify the State agency of the change in management for 1 of 1 home health agency. (Employee C) Findings include: A November 2018 signed job description titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "When the Administrator is not available, a qualified, pre-designated person, who is authorized in writing by the Administrator and the governing body assumes the same responsibilities and obligations as the Administrator. A review of the State database information indicated former employee U was the Alternate Administrator. During entrance conference on 10/4/2021 at 10:30 a.m. employee C indicated he/she was the Alternate Administrator. During entrance conference on 10/4/2021 at 10:10 p.m. the Administrator was asked to provide the appointment letter for the Alternate Administrator. On 10/4/2021 at 1:30 p.m. the Administrator provide a document dated September 21, 2021 that indicated employee C was replacing employee U as the Alternate Administrator signed by non-employee P, Regulatory Coordinator, from Baton Rouge, LA. Informed the Administrator that the document provided was not an appointment letter, but a notification to the State agency. The Administrator was asked who appointed employee C as Alternate Administrator and if there was a confirmation letter received from the State agency regarding the change to which he/she replied "I will find out." During an interview on 10/5/2021 at 9:55 a.m. the Administrator provided an appointment letter that was dated 3/22/2021, digitally signed by non-employee W, President of Home Health. The letter indicated "As of February 25, 2021, the Governing Body has appointed [name of employee C] R.N., as the Alternate Supervising Nurse of Amedisys Sp-IN, L.L.C. d/b/a Amedisys Home Health. (Bloomington). Notification has been made to the state of Indiana accordingly. Governing Body Representative: [non-employee W] Digitally signed by [non-employee W] ... Date 2021.03.22 ... President of Home Health" The Administrator indicated non-employee W was a Governing Body member at that time, but was no longer currently employed. A review of 3 Governing Body members lists that were provided by the Administrator did not indicate non-employee W was a past member of the Governing Body. At that time, a review of the State database did not indicate non-employee W was a past Governing Body member. The Administrator was not able to provide the confirmation letter from the State agency regarding management changes. The Administrator was asked why he/she did not submit the information to State instead of non-employee P from Louisiana, to which he/she did not answer. The parent agency failed to notify the State agency of management changes. The agency failed to authorize in writing by the Administrator and Governing Body an Alternate Administrator. 17-12-1(c)(8)

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on record review and interview the clinical manager failed to ensure that patient needs were continually assessed for 1 of 2 patients reviewed from the complaint log. (Patient 1) Findings include: 1. A revised policy dated 09/17/2021 titled Physician Orders was provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated but was not limited to, "All patient care orders from all physicians, including verbal orders, must be recorded/integrated in the plan of care to assure coordination of all services and interventions." 2. A revised policy dated 04/29/2021 titled On-Call/On-Call Book Format was provided by non-employee B on 10/04/2021 at 2:33 p.m. The document indicated but was not limited to, "Procedure ... 3. After business hours and on weekends and holidays, coverage is available twenty-four (24) hours a day ... c. The on-call clinician should call the patient or caregiver as soon as possible but at least within 15 minutes. d. The on-call clinician responding to after-hours phone calls is responsible for documenting coordination of care activities in response to calls on a Care Coordination Note ..." 3. A revised policy dated 12/04/2020 titled Laboratory Values Reporting was provided by provided by non-employee B on 10/04/2021 at 11:51 a.m. The document indicated, but was not limited to, “1. Clinicians receiving a critical laboratory value from reference laboratory will report the critical value to the physician of [on] record within one hour of receipt ... “ 4. The complete clinical record for patient 1, Start of Care (SOC) 07/21/2021, was reviewed on 10/04/2021 and evidenced the following: A document titled "Client Coordination Notes Report" dated 09/08/2021 signed by employee T indicated the following: "Patient has had increased fatigue as well as confusion ... had low bp [blood pressure] this a.m. ... caregiver has also requested urinalysis and has been unable to obtain specimen ... daughter reports patient is incontinent most of the time and has foul smelling urine." A document titled "Client Coordination Notes Report" dated 09/09/2021 signed by employee V indicated the following: "Spoke to ... at Dr. ... office ... order for UA [urinalysis] ... explained ... we could send a nurse out for an eval and to collect the urine, but would not be until at least Monday [5 days later] due to clinicians on quarantine ... do they want patient to wait ... will have someone from office call HHC [home healthcare] back.” A document titled "Patient Information Report" dated 09/16/2021 signed by employee S at 11:34 a.m. indicated the following, "patients son reporting patient has increased edema in hands and feet as well as abdominal distention." A document titled "Patient Information Report" dated 09/16/2021 signed by employee G indicated the following, "Time of Call: 1854 [6:54 p.m.] 9.15.21 Name of Caller: ... Family Member ... Purpose of call ... calling to speak with charge nurse or admin for complaint Action taken: Instructed to call back on Thursday during business hours to speak with management ..." A document titled "Patient Information Report" dated 09/17/2021 signed by employee G indicated the following, "Time of Call: 0730 Name of Caller (Relationship to Patient): LabCorp ... Purpose of Call: Calling with critical value ..." Employee G failed to notify the physician of patient 1's critical lab value within 1 hour. A document titled "Patient Information Report" dated 09/17/2021 signed by employee T at 11:42 a.m. indicated the following, "Received call ... of critical lab. Hgb [an iron-rich protein found in red blood cells that is primarily responsible for carrying oxygen from your lungs to the rest of the cells in the tissues and organs of your body. Normal values for a female is 12.0 to 15.5.] of 5.8. Lab result is called to ... at Dr. ... office. Awaiting further instruction ..." A document titled "Patient Information Report" dated 09/19/2021 signed by employee U at 4:42 p.m. indicated the following, "Received phone call from ... at Dr. ... 9/17/2021 @ [at] 1438 [2:38 p.m.]. Wanting patient taken to ED [emergency department] for eval and treatment due to low hgb ... at 1500 [3:00 p.m.] Received second phone call from ... at Dr. ... office stating daughter called, demanding direct admit, which Dr. ... is unable to do ... unsure if patient will be taken to ED." A document titled "Patient Information Report" dated 09/21/2021 signed by employee V at 11:33 a.m. indicated the following, "Admitted to [hospital] 9/19 ... DX [Diagnosis]: GI [Gastrointestinal] Bleed. 5. During an interview on 10/06/2021 the administrator stated that she spoke to employee W, Registered Nurse, and employee W stated she spoke with the patient's family, and they agreed to wait a week to obtain a urine sample, but the clinical record failed to evidence that conversation. 6. During an interview on 10/06/2021 with the administrator when asked why employee G did not send a nurse to assess the patient on 9/16/2021 after patient 1's son called to report a change in condition, the administrator stated she spoke to employee G and the employee did call an on-call nurse and they never responded. When asked if any further attempts were made or if their policy required more effort be made, the administrator stated yes, employee G should have made more attempts and she failed to do so. The skilled professional failed to include documentation in the clinical record of attempts to reach an on-call nurse. 7. During an interview on 10/06/2021 at 3:55 p.m. the administrator stated employee G failed to follow policy and notify the physician of the critical value within 1 hour. The administrator stated the employee attempted to call the Lab back to obtain what the critical value was and did not receive a response. The administrator stated employee G did not document in the clinical record an attempt to call the lab back.

Parent-branch relationship CFR(s): 484.105(d) Standard: Parent-branch relationship. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the lines of authority and professional and administrative control were clearly delineated in the agency's organizational structure for 1 of 1 home health agency. Findings include: A 6/24/21 policy titled Governing Body was provided by Clinical Manager C on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "The Governing Body assumes full legal authority and responsibility for the policies and procedures that govern the day-to-day operations of each home health agency owned by the direct and indirect operating subsidiaries of Amedisys, Inc. (such operating subsidiaries are collectively referred to herein as "Amedisys"). The Policy/Bylaws of the Governing Body outline the responsibilities and authority of the Governing Body. ... 4. ... a. The Governing Body will develop an organizational structure for each Amedisys home health agency: the Administrator/Director of Operations (DOO) (or regional DOO/Acting or Interim DOO, or person with a similar function) of each home health agency will follow a chain of command by reporting to a designated Area Vice President (AVP), who reports to a designated Vice President of Operations who reports to a designated Senior Vice President of Operations in communicating information to the Governing Body. ... c. State survey results for individual Amedisys agencies will be monitored by the Amedisys, Inc. Regulatory Services Department and reported to the Governing Body on an ongoing basis. ..." A November 2018 signed job description titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Responsible to ADOO (area director of operations) or Area Vice President of Operations ... Director of Operations Job Duties ... Assist Branch Directors in resolving patient and / or staff complaints ... investigating and documenting the event, and notifying the person lodging the complaint to resolve the issues 10. Assists and coordinates, with the Area Vice President of Operations, the budget development process, implementation and evaluation." The agency failed to ensure the Administrator reports to the Governing Body. An undated job description titled Alternate Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Responsible to Area Vice President of Operations" During entrance conference on 10/4/2021 at 10:10 a.m. the Administrator indicated he/she reported to non-employee D Area Vice President of Operations and attends the Governing Body meetings. The Administrator confirmed he/she was the Administrator/DOO (director of operations). The Administrator was asked who the members of the governing body were to which he/she replied "I will get you the list." The Administrator indicated the Director of Operations D of the Terre Haute branch oversees the QAPI at the branch and then submits the QAPI to the Administrator for review. The Administrator indicated there were contract nurses at the Terre Haute and Indianapolis branches but was unsure who with. The Administrator was asked how he/she adequately supervises the branches. The Administrator indicated he/she goes to the Terre Haute branch quarterly and was at the Indianapolis branch last Friday [October 1st]. The Administrator indicated he/she was unsure the exact date when the first patient was seen at the Indianapolis branch. The Administrator indicated that non-employee Regional Director of Operations was used as a resource and covers the Indianapolis branch office when the Administrator was not available. The Administrator was asked to identify the person who will resolve patient care issues at the branch, and explain how supervision by the HHA parent will occur. The Administrator confirmed he/she will resolve patient care issues/supervise at Bloomington and the Indianapolis branch and Director of Operations D will resolve patient issues/supervise at Terre Haute. The Administrator confirmed the agency has a Director of Operations at the Terre Haute branch and was planning on hiring a Director of Operations for the Indianapolis branch as well. Review of two organizational charts provided by Clinical Manager C on 10/4/2021 at 1:30 p.m. One organizational chart indicated the Administrator reports to non-employee Area Vice President of Clinical Services C, and non-employee Area Vice President of Operations D. The other chart indicated the Administrator reports to the Governing Body (no specific names listed). On 10/5/2021 at 4:30 p.m. Area Vice President of Clinical Services C confirmed he/she was not an employee of the Bloomington agency and not a member of the Governing Body, but was an "Amedisys" employee. Review of the Indianapolis branch information submitted to the State agency included an organizational chart that indicated the Administrator reports to the Area Vice President of Clinical Services. Review of the Indianapolis branch information submitted to the State agency titled Detailed Description of Hiring,Training, and Supervision for the Parent and Branch indicated, "II. Hiring ... Staffing Plan: The Branch is planning to hire following full time members: Director of Operations, Office Manager, Registered Nurse, Physical Therapist, Occupational Therapist ..." The Indianapolis branch information that was submitted to the State agency indicated the Administrator will report to the Regional Administrator who reports to the Vice President and then to Corporate. On 10/4/2021 at 1:30 p.m. the Administrator provide a document dated September 21, 2021 that indicated employee C was replacing employee U as the Alternate Administrator, signed by non-employee P, Regulatory Coordinator, from Baton Rouge, LA. Informed the Administrator that the document provided was not an appointment letter, but a notification to the State agency. The Administrator was asked who appointed employee C as Alternate Administrator and if there was a confirmation letter received from the State agency regarding the change to which he/she replied "I will find out."

Direct support and administrative control CFR(s): 484.105(d)(2) The parent HHA provides direct support and administrative control of its branches. This ELEMENT is not met as evidenced by: Based on record review and interview, the parent agency failed to ensure direct support and administrative control of its branches for 1 of 1 home health agency. Findings include: A November 2018 job description policy titled Director of Operations/Administrator was provided by the Administrator on 10/4/2021 at 2:08 p.m. The job description indicated, but was not limited to, "Administrator Job Duties ... Assist Branch Directors in resolving patient or staff complaints ..." A 6/24/21 policy titled Grievance/Complaint was provided by Clinical Manager C on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "4) The Director of Operations/designee must documentation [sic] of all components of the investigation ... a) Log complaint on complaint log ... 5) The Director of Operations, or designee, is responsible for reviewing every complaint ... " A 2/18/21 Regional Director of Operations job description was provided on 10/6/2021 at 2:30 p.m. The job description indicated, but was not limited to, "Provides direction and management on overall organization and direction of care center operations and functions ... 11. Assist with the temporary coverage of the Director of Operations role as needed. ... 14. Assists in investigation and resolution of complaints. During entrance conference on 10/4/2021 at 10:10 a.m. the Administrator indicated he/she reported to non-employee Area Vice President of Operations D and attends the Governing Body meetings. The Administrator confirmed he/she was the Administrator/DOO (director of operations). The Administrator was asked who the members of the governing body were to which he/she replied "I will get you the list." (See G946) The Administrator indicated the Director of Operations D of the Terre Haute branch oversees the QAPI at the branch and then submits the QAPI to the Administrator for review. The Administrator indicated there were contract nurses at the Terre Haute and Indianapolis branches but was unsure who with. The Administrator was asked how he/she adequately supervises the branches. The Administrator indicated he/she goes to the Terre Haute branch quarterly and was at the Indianapolis branch last Friday [October 1st]. The Administrator indicated he/she was unsure the exact date when the first patient was seen at the Indianapolis branch. The Administrator indicated that non-employee Regional Director of Operations B was used as a resource and covers the Indianapolis branch office when the Administrator was not available. The Administrator was asked to identify the person who will resolve patient care issues at the branch, and explain how supervision by the HHA parent will occur. The Administrator confirmed he/she will resolve patient care issues/supervise at Bloomington and the Indianapolis branch and Director of Operations D will resolve patient issues/supervise at Terre Haute. The Administrator confirmed the agency has a Director of Operations at the Terre Haute branch and was planning on hiring a Director of Operations for the Indianapolis branch as well. During a review of the Complaint Log on 10/4/2021 the Administrator indicated the Terre Haute branch complaints are not in the complaint log book, but in Sharepoint and would run the report. All complaints from the Terre Haute branch indicate the Director of Operations D investigated, documented, and resolved the issues. The agency failed to ensure supervision and administrative control of the branch on a daily basis. 17-12-1(a)(2)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed provide services in accordance with accepted professional standards of practice regarding wound measurements for 1 of 1 wound measurement observations. (Patient 4) Findings include: A 2/25/2020 Wound Care Advisor article titled Measuring Wounds states, "When measuring depth: Place a cotton-tip applicator into the deepest part of the wound bed. Grasp the applicator by the wound margin and place it against the ruler ... " A 10/2019 Nursing 2020 article titled Wound 101 states, " ... If the wound has depth, measure from the deepest point of the wound to the wound surface using a sterile cotton-tip applicator." http://journals/Fulltext/2019/10000/Wound_Care_101.10.aspx A 2014 National Pressure Ulcer Advisory Panel article titled Prevention and Treatment of Pressure Ulcers: Quick Reference Guide, states, "Pressure Ulcer Assessment ... 7. Select a consistent, uniform method for measuring depth ..." A 2019 policy titled Guide for Measuring Wounds was provided by Clinical Manager C on 10/5/2021 at 12:00 p.m. The policy indicated, but was not limited to, "Depth is measured by inserting a cotton-tipped applicator at the deepest point in the wound ..." During a home visit on 10/4/2021 at 2:45 p.m. LPN H was observed measuring patient 4's wounds using a paper measure tool. LPN H was observed measuring length and wide for 2 wounds on the left lower leg and 1 wound on the right. LPN H failed to use a sterile q-tip to measure for depth on all 3 wounds. During an interview on 10/4/2021 at 4:30 p.m. Clinical Manager C confirmed the LPN should have used a q-tip to measure for depth of all 3 wounds.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to document education interventions as ordered on the Plan of Care for 3 of 4 record reviews (Patient 3, 5,10,13) Findings include: 1. A revised 9/17/21 policy titled Physician Orders and Medical Supervision of the Plan of Care was provided by the Clinical Manager (CM) on 10/5/2021 at 8:25 a.m. The policy indicated, but was not limited to, "PURPOSE: ●…The agency provides care and services according to the most recent physician orders…" 2. The complete clinical record for patient 3, start of care date 10/28/20, was reviewed on 10/4/2021, and included a plan of care for the certification period 8/24/2021 to 10/22/2021 with orders for skilled nurse to teaching/education in fall prevention, home safety, medication management, nutrition management, neurological system management, Parkinson’s Disease management, genitourinary management, indwelling catheter management, and risk for hospitalization. The record indicated the following: Visit Note Reports for 9/8, 9/12, 9/13 of 2021 failed to evidence the skilled nurse documented any teaching on the following interventions or the patient understood and retained the information: A) Fall prevention B) Home Safety C) Nutrition Management D) Medication Management: use, dosage, frequency, purpose, side effects, and reporting complications E) Risk for Hospitalization: Signs and symptoms that put patient at risk, when to notify nurse of complications/decline, when to call 911, signs and symptoms to be on alert for early intervention prior to needing emergency services, when to call Amedisys nurse, and keep on call symptom report visibly for reference F) Neurological System Management: altered status to minimize complications and reduce hospitalization G) Parkinson’s Management: Parkinson’s disease for self-care H) Genitourinary Management: Altered genitourinary status to minimize complications and reduce hospitalizations 3. The complete clinical record for patient 5, start of care date 7/30/2021 was reviewed on 10/4/2021 and included a plan of care for the certification period 7/30/2021 to 9/27/2021, with orders for skilled nurse to provide teaching/education in fall prevention, home safety, medication management, infection prevention, nutrition management, diabetes management, pain management techniques, IV therapy management and administration, sepsis and self-management techniques, general wound and skin care, and risk for hospitalization. The record indicated the following: Visit Note Reports for 7/30, 8/4, 8/12, 8/16, 8/23, 8/30, 9/7, 9/13, 9/20, and 9/27 of 2021 failed to evidence the skilled nurse documented any teaching on the following interventions or the patient understood and retained the information: A) Medication Management: dosage, frequency, purpose, and side effects B) Diabetes Management: ADA diet, skin care, signs and symptoms of hypo/hyperglycemia, proper administration of diabetic medication, diabetic foot care, and importance of HGBA1C monitoring, kidney function test, and eye/foot exams. C) Pain Management techniques D) General Wound and Skin Care 4. The complete clinical record for patient 13, start of care date 8/14/2021 was reviewed on 10/6/2021 and included a plan of care for the certification period 8/14/2021 to 10/12/2021, with orders for skilled nurse to provide teaching/education in fall prevention, home safety, medication management, infection prevention, nutrition management, diabetes management, pain management techniques, self-management of the pleural drainage system on the right chest drain catheter, cancer management, altered cardiovascular status to minimize complications, atrial fibrillation management, anticoagulation management, and risk for hospitalization. The record indicated the following: Visit Note Reports for 8/14, 8/16, 8/19, 8/23, 9/3, 9/6, 9/8, 9/13, 9/15, 9/18, 9/20, 9/23, and 9/27 of 2021 failed to evidence the skilled nurse documented any teaching on the following interventions or the patient understood and retained the information: A) Medication Management: use, dosage, frequency, purpose, side effects, and reporting complications B) Anticoagulation Management: signs and symptoms of bleeding/adverse reactions to report to physician C) Diabetes Management: skin care, signs and symptoms of hypo/hyperglycemia, and importance of HGBA1C monitoring, kidney function test, and eye/foot exams. D) Cancer Management: cancer E) Cardiovascular System Management: altered cardiovascular status to minimize complications 5. During an interview on 10/4/2021 at 2:40 p.m. with the Clinical Manager (CM) indicated ordered teaching or education on plans of care should be documented in the “Narrative” or within the “Interventions Completed” sections of the Visit Note. CM indicated there are ways to show what is completed and therefore it should be done to determine what still needs to be taught or implemented throughout the certifications period.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all entries in the clinical record are accurate, clear, and complete for 1 of 2 wound care observations. (Patient 4) Findings include: A March 2021 job description titled Licensed Practical Nurse was provided by Office Manager E on 10/6/2021 at 3 p.m. The job description indicated, but was not limited to, "6. Documents clinical notes in the home" During a home visit on 10/4/2021 at 2:45 p.m. LPN H was observed measuring patient 4's right lateral lower leg wound 4 cm (centimeters) x 3 cm with a paper measuring tool then used the same tool to measure left lateral lower leg wound 12 cm x 5 cm. LPN H used the same paper measuring tool to measure right posterior lower leg wound as 2.3 cm x 2 cm. LPN H did not measure wound depth on any of the wounds. LPN H reached into patient supplies with soiled gloves on and opened Hibiclens bottle. LPN H indicated he/she could not remember the measurements. LPN H re-measured left lateral lower leg wound as 4 cm x 2.5 cm and right posterior lower leg wound as 2.5 cm x 1.5 cm. LPN H failed to measure depth of wounds. A review of the Wound Assessment Tool Report dated 10/4/2021 at 3:59 p.m. indicated wound measurements for patient 4's right lateral lower leg wound as Length 4 cm x Width 1.5 cm x 0.1 cm depth, right posterior lower leg wound as 2 cm x 1.5 cm x 0.2 cm depth; and left lateral lower leg wound as 12 cm x 5 cm x 0.2 cm depth. LPN H failed to accurately document the measurements taken at the home into patient 4's clinical record. A review of the Visit Note Report dated 10/4/2021 at 3:59 p.m. indicated PERRL was performed at patient 4's home visit. During patient 4's home visit LPN H did not complete PERRL (assessment of eyes with reaction to light). The Visit note did not accurately reflect the care provided at the home visit. During an interview on 10/4/2021 at 4:30 p.m. Clinical Manager C was asked what his/her expectation was for measuring depth of wounds. Clinical Manager C indicated the clinicians should use a q-tip to measure wound depth and use a pen light to assess PERRL. Clinical Manager C was unable to provide any additional information regarding the accuracy of documentation. 17-15-1(a)(7)

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102, for a home health agency. Survey Dates: 1-26, 1-27, 1-28, 1-29, 2-1, & 2-2-21 Facility: 004926

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) [(b) Policies and procedures. The [facilities] 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 (annually for LTC).] At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure it had solicited volunteers for service during a disaster or emergency, to include their roles for integration with health care professionals during the disaster/emergency for 1 of 1 home health agency disaster preparedness plan. Findings included: Review of Agency's Emergency Preparedness plan on 1-29-21, failed to evidence the use of volunteers in their emergency preparedness plan. On 1-29-21 at 2:43 p.m., Clinical Manager, Employee C and non-employee Entity A confirmed the lack of use of volunteers in their Emergency Preparedness program. On 1-29-21 at 2:48 p.m., during daily review of the above findings and when queried for additional information, the Administrator provided nothing further.

This visit was for a federal recertification, focused infection control, and state licensure survey. This survey was extended on 1-28-21 at 4:08 p.m. Survey Dates: 1-26, 1-27, 1-28, 1-29, 2-1, & 2-2-21 Facility: 004926 These deficiencies reflect state findings in accordance with 410 IAC 17. Refer to state form for additional findings. Quality Review completed on 2/24/2021 A4

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 and record review, the agency failed to follow standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases in 2 of 5 home visits. (Patient #5, #7) Findings included: 1. Review of agency policy titled "Hand Hygiene", last revised 9/18, stated: ". . . The agency must follow accepted standards of practice, including the use of standard precautions (includes hand hygiene), to prevent the transmission of infections and communicable diseases. . . Perform hand hygiene as follows: a. Before having direct contact with patients. b. Before donning gloves. . . d. After contact with a patient's intact skin. . . f. When moving from a contaminated body site to a clean body site during patient care. g. After contact with inanimate objects (e.g., medical equipment) in the immediate vicinity of the patient. H. After removing gloves. . . Remove gloves after caring for a patient. . . change gloves during patient care if moving from a contaminated body site to a clean body site. . ." 2. During a home visit with Patient #5 on 1/28/21 at 10:00 a.m., agency Physical Therapist, Employee I, was observed sanitizing their hands and donning gloves then performing a physical assessment of Patient #5 which included the performance of vital sign measurement, cleaning of vital sign equipment, documentation of vital signs in patient's folder, placement of gait belt, ambulation of and assist in movement of Patient #5, instruction in patient exercises, cleaning of own fogged face shield with gloved hand, & documentation of home visit, all without changing of gloves and sanitizing hands. Upon completion of care, Employee I, removed the original pair of gloves and sanitized hands. 3. During a home visit with Patient #7 on 1/28/21 at 12:15 p.m., Registered Nurse, Employee D was observed preparing a medication vial for an intramuscular injection by removing vial cap and inserting needle to withdraw medication. This attempt was unsuccessful, and Employee D retrieved a larger gauge needle and accessed the vial without sanitizing vial hub. Further observation evidenced Employee D, with gloved hands, performing medication reconciliation for Patient #7 then contacting Patient #7's pharmacy using Employee D's cell phone then proceeding to fill Patient #7's medication planner. Employee D failed to change her gloves and sanitize her hands when moving from clean to dirty to clean environment. Employee D was then observed providing a written medication list to Patient #7's spouse then removed her gloves and cleaned her computer tablet without sanitizing her hands. Employee D was not observed performing hand hygiene at the conclusion of the home visit. 4. On 1-29-21 at 2:48 p.m., during daily review of the above findings and when queried for additional information, the Administrator provided nothing further. 17-12-1(m)

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to provide evidence of the Administrator reporting to the Governing Body for 1 of 1 agency. Findings included: Review of Agency policy titled "Governing Body", last revised 6/2020, stated: ". . . must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operation plans, and its quality assessment and performance improvement program. . . will develop an organization structure for each Amedisys home health agency: the Administrator/Director of Operations (DOO) (or regional DOO/Acting or Interim DOO, or person with a similar function) of each home health agency will follow a chain of command by reporting to a designated Area Vice President (AVP), who reports to a designated Vice President of Operations who reports to a designated Senior Vice President of Operations in communicating pertinent information to the Governing Body; . . . annually review and adopt policies for the operation and administration . . . ensure that an annual operating budget and capital expenditure plan. . . ensure that there are adequate resources. . . establish, maintain and ensure that an organization-wide performance improvement program for quality improvement and patient safety. . . review and annually approve the quality improvement/infection prevention/safety program. . ." Review of the "2020 Bi-Annual Governing Body Meeting Minutes" provided on 1-27-21 at 10:52 a.m. by the Clinical Manager and dated 10-14-2020 at 1:00 p.m., failed to evidence the attendance of the Agency Administrator and failed to evidence or mention any Agency operational items specific to said Agency such as an operational plan, budget and/or quality assurance/performance improvement activities (QAPI). During an interview with the Alternate Administrator on 1-27-21 at 2:37 p.m., when queried as to involvement with or attendance/reporting to the Governing Board, the Alternate Administrator responded "No, that is more of a corporate thing (responsibility)." During an interview with the Administrator on 1-28-21 at 4:06 p.m., when queried as to involvement with or attendance/reporting to the Governing Board, the Administrator responded "Honestly not much role. Mainly COPs (Conditions of Participation) and accreditation standards." When queried further if the attendance or meetings was more of an education/training session instead of the Administrator reporting on agency function and operation, the Administrator stated "Yes". 17-12-1(c)(2)

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to establish and communicate clear, distinct lines of authority in the absence of the Administrator for 1 of 1 agency. Findings include: Review of the Agency's Organizational chart received on 1-27-21 at 9:50 a.m., failed to identify names of individuals for each identified/listed position. Review of the Agency's Organization chart first received on 1-26-21 at 2:55 p.m. from the Area Vice President of Clinical Services failed to identify the position and associated names of any of the positions listed as well as the name and position of the Alternate Administrator. Review of the Agency's Organizational chart received again on 1-27-21 at 1:30 p.m., failed to identify the position and associated name of the Alternate Administrator as well as any positions listed for the Agency. Review of the Indiana state form titled "Division of Acute Care, Indiana State Department of Health Home Health Agencies Report" completed and submitted by the Agency on 1-27-21 at 10:14 a.m., listed the Clinical Manager for the parent Agency, Registered Nurse, Employee C as the Agency's Alternate Administrator. At the time of this survey entrance conference and during interview with the announced Clinical Manager for the parent location on 1-26-21 at 12:36 p.m., the Clinical Manager, Employee C, for the parent location reported she was the Alternate Administrator for said Agency. When queried as to access to patient documents for the branch location in Terre Haute, IN, she reported she did not have access to their patients. During an interview with the Area Vice President of Clinical Operations for the Agency's owning company, Non-agency Entity A, on 2-27-21 at 9:56 a.m., Entity A was unable to identify the Alternate Administrator on the organizational chart and stated she believed it was Employee C. During an interview with the branch office location's "Director of Operations" Clinical Manager on 2-27-21 at 2:37 p.m., when queried as to the Alternate Administrator for the Agency, she stated "(I) think (called by name) Employee C would be the Alternate Administrator." When queried as to access to the parent agency office patient's she stated, "I do (have access), at least some of them." During an interview with the Agency's Administrator on 2-28-21 at 1:13 p.m., when queried as to the name of the person to serve as her alternate in her absence, she stated: "(Called employee name-Employee B)" On 2-2-21 at 3:45 p.m., during review of the above findings and when queried for additional information, the Administrator provided nothing further. 17-12-1(c)(8)

Direct support and administrative control CFR(s): 484.105(d)(2) The parent HHA provides direct support and administrative control of its branches. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to provide administrative control of its branch location for 1 of 1 agency and 1 of 1 branch. Findings included: On 1-26-21 at 12:36, during survey entrance conference, Registered Nurse, Employee C reported agency had a branch office location in Terre Haute, IN, with Registered Nurse, Employee B as their Clinical Manager. On 1-27-21 at 9:50 a.m., the Director of Operations for the branch office location (Clinical Manager) provided an organizational chart which evidenced the branch Director of Operations reported to the Administrator/Director of Operations. This organizational chart failed to evidence names of individuals holding these positions. During interview with the parent office's Clinical Manager and Registered Nurse, Employee C on 1-27-21 at 10:45 a.m., stated: "I don't have anything to do (oversight) with the Terre Haute office (branch). Their EP (emergency preparedness) is separate from Terre Haute (branch office location)." During an interview with non-agency Entity A on 1-27-21 at 2:37 p.m., stated: "Terre Haute (branch office) has their own separate QAPI (Quality Assurance Performance Improvement), it's online." When queried as to who covers for the branch clinical manager in her absence, non-agency Entity A responded: "I don't know. I will have to look who is reported to the state." During an interview with the branch Director of Operations (Clinical Manager) on 1-27-21 at 2:38 p.m., the Director stated: ". . . Think (called by name) Employee C would be the Alternate Administrator. . . My performance evaluation is done by (the) AVP (Area Vice President) of Operations, non-employee entity B . . . We have our own separate EP and turn it into corporate, not Bloomington (parent). . . QAPI is turned into corporate too. . . The Bloomington (parent) office manager has access (branch personnel files), but our (branch) office manager maintains the electronic copies. . . (access to parent office patient records) I do, some of them. All of them." On 2-2-21 at 3:45 p.m., during final review of the above findings and when queried for additional information, the Administrator provided nothing further. 17-12-1(a)(1) 17-12-1(a)(2)

Institutional planning CFR(s): 484.105(h) Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1) Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense. (2) Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA. (4) Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to participate in the preparation of the agency annual plan and the governing board minutes failed to evidence plan & budgetary oversight for said agency for 1 of 1 agency with 1 of 1 branch location. Findings included: Review of Agency policy titled "Governing Body", last revised 6/2020, stated: ". . . must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operation plans, and its quality assessment and performance improvement program. . . will develop an organization structure for each Amedisys home health agency: the Administrator/Director of Operations (DOO) (or regional DOO/Acting or Interim DOO, or person with a similar function) of each home health agency will follow a chain of command by reporting to a designated Area Vice President (AVP), who reports to a designated Vice President of Operations who reports to a designated Senior Vice President of Operations in communicating pertinent information to the Governing Body; . . . annually review and adopt policies for the operation and administration . . . ensure that an annual operating budget and capital expenditure plan. . . ensure that there are adequate resources. . . establish, maintain and ensure that an organization-wide performance improvement program for quality improvement and patient safety. . . review and annually approve the quality improvement/infection prevention/safety program. . ." During an interview with the Administrator on 1-28-21 at 1:13 p.m., the Administrator stated: "I (manage) QAPI (quality assurance & performance improvement). All forms are loaded into Sharepoint (company software system). Our AVPC (area vice president of clinical services) and AVPO (area vice president of operations) review it and I update based on their and my review." When queried if input into the agency's budget, the Administrator responded: "No. It comes from Leadership." When queried who Leadership was, the Administrator stated: "The AVP's then to me. (Called AVP by name) Non-entity B, sends to me." When queried if has any specific contact with the Governing Board, the Administrator responded: "Not since I have taken this role (Administrator). We have team meetings with the VP (vice presidents) of home care." When queried as to content of the discussion, agency specific needs or corporate business, the Administrator stated: "Overall company business." The Administrator further stated: "I was right, the governing board develops the budget with input from the area vice presidents and then they reach out to us as a group (corporation's agency administrators)." On 1-29-21 at 2:48 p.m., during daily review of the above findings and when queried for additional information, the Administrator provided nothing further. 17-12-1(b)(3)