Every finding on record at Valparaiso Home Care Services, LLC

This visit was a complaint survey for a hospice agency conducted by the Indiana Department of Health. Complaint #96654-deficiencies cited Survey Dates: 4/5/2023, 4/6/2023, 4/10/2023, and 4/11/2023. Facility ID: 005259 Active Patient Census: 96 Total Unduplicated Census Last 12 months: 914 Quality Reviewed 04/25/2023

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a comprehensive assessment was completed in 2 of 2 active clinical records reviewed where a decline in the patient’s health status occurred (Patient #1, 3). The findings include: 1. Record review evidenced an agency policy revised 3/1/2022, titled "Patient Assessment, Initial and Reassessment" which stated, "... A qualified clinician performs a comprehensive assessment or reassessment visit in the following situations: ... When the instability or acuity of the patient's medical condition warrants assessment [significant improvement or major decline] ...." 2. Clinical record review for Patient #1 was completed on 4/11/2023. Record review evidenced a comprehensive assessment for recertification of services, dated 3/23/2023. The document evidenced the patient weighed 130 pounds, had properly fitting, partial, removable, upper and lower dentures, and failed to evidence any chewing/swallowing concerns were identified; and the patient was at a high/major nutritional risk. Record review evidenced a plan of care for certification period 3/27/2023 – 5/25/2023, which evidenced the patient's diagnoses included heart failure, kidney disease with dependence on dialysis, diabetes, and dementia. Record review evidenced a Registered Nurse (RN) visit note dated 3/30/2023, which evidenced the patient weighed 124 pounds (6 pound weight loss in one week), the patient indicated he wasn't eating well due to issues with his teeth, and the RN encouraged the patient to eat soft foods in order to ensure caloric intake. Record review evidenced a RN visit note dated 4/04/2023, which evidenced the patient weighed 129 pounds (5 pound weight gain in one week), random blood sugar level was 354 (normal range 70-110), had pitting edema (indicates fluid retention) to both feet, the patient reported a chronic cough at night, and had difficulty breathing while walking and with activity, his appetite was poor, was non-compliant with taking insulin as ordered by the physician, and hasn't check his blood sugar levels since the last nursing visit (3/30/2023). Record review failed to evidence any nursing visits were made after 4/04/2023 (as of 4/11/2023). On 4/11/2023 at 1:15 PM, the Clinical Manager indicated the patient was not reassessed. 3. Clinical record review for Patient #3 was completed on 4/11/2023. Record review evidenced an initial comprehensive assessment, dated 3/18/2023. The document evidenced the patient's diagnoses included heart failure, which was poorly controlled, and required frequent adjustments in treatment and dose monitoring; the patient's weight was 125 pounds, had no swelling of the lower legs or feet, and no current heart issues were identified. Record review evidenced a plan of care for certification period 3/18/2023 – 5/16/2023, evidenced the patient's primary focus of home care was Physical Therapy (PT) and Occupational Therapy (OT). Record review evidenced an Occupational Therapy (OT) evaluation visit note dated 3/20/2023. The document evidenced the patient's weight was 125.4 pounds (0.4 pound weight increase), pitting edema was assessed, the patient got short of breath easily, had difficulty breathing with minimal exertion, and had a cough. Record review evidenced a Medical Social Worker (MSW) visit note dated 3/21/2023. The document evidenced the patient had moderate to severe anxiety/fear/excessive worries, and depression; and the patient indicated an anxiety pill may be missing from her pill box, which might be contributing to increased anxiety. Record review evidenced a Physical Therapy Assistant (PTA) visit note dated 3/23/2023. The document failed to evidence if the patient's weight or anxiety level was assessed, or if the anxiety medication was in the patient's pill box. Record review evidenced an OT visit note dated 3/27/23. The document evidenced the physician was notified of the patient's weight of 128.8 pounds (3.4 pound weight gain in 6 days), and fluctuating heart rate from 50-135 beats per minute (normal range 60-110). Record review evidenced a PTA visit note dated 3/30/2023. The document evidenced the physician was notified the patient felt "wiped out", reported some chest pain while coughing, the front of her chest ached, resting heart rate was 102-117 beats per minute, and had pitting edema to the right foot/ankle. Record review evidenced a clinical coordination note dated 3/31/2023. This document evidenced the MSW provided a telephonic MSW visit, and family reported the patient sustained a fall (no date identified). Record review evidenced a RN evaluation visit note dated 4/03/2023. The document evidenced the patient's weight was 129.4 pounds (0.6 pound weight gain in 4 days); was short of breath with exertion, and had expiratory wheezing (compromised airflow); and failed to evidence any follow up for reported fall. The document also failed to evidence administration of OASIS data. During an interview on 4/11/2023 at 2:36 PM, the Administrator confirmed the comprehensive assessment wasn't completed for the patient's change in condition, the Clinical Manager did call to check on the patients, and the agency had limited nursing staff.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure care was coordinated in 1 of 7 active clinical records reviewed. (Patient #5) The findings include: Record review evidenced an agency policy revised 4/1/2023, titled "Coordination of Care, from Admit through Discharge" which stated, "... When the patient receives services from other organizations and/or individual's care is coordinated to ensure that patient's needs are met efficiently, without duplication of services, including: ... Communication with other health care providers when there are significant changes in patient care and/or condition ...." Clinical record review for Patient #5 was completed on 4/11/2023. Record review evidenced a plan of care for certification period 3/29/2023 - 5/27/2023, which indicated the patient was to receive dressing changes to a malignant back lesion 3 times weekly: 2 times weekly from the skilled nurses, and 1 time weekly from Entity #2 (mobile wound clinic). During an interview on 4/11/2023, at 2:00 PM, Person #3 (employee of Entity #2) indicated Patient #5 was discharged from services on 3/22/2023, due to coccyx (area at base of spine) wound being healed. Record review failed to evidence the patient received dressing changes to the malignant back lesion 3 times weekly as ordered on the plan of care for the weeks of 3/26/2023, and 4/2/2023. Record review failed to evidence any care coordination with Entity #2 (mobile wound clinic). During an interview on 4/11/2023, at 10:39 AM, the Administrator indicated the agency should have coordinated care with Entity #2 by calling them, and having them send over orders. The Administrator indicated they did not have any documentation of when the patient was discharged from Entity #2. The Administrator indicated the patient should have received dressing changes 3 times weekly even after Entity #2 discharged the patient.

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 home health agency failed to ensure skilled professionals provided services as ordered in the plan of care in 3 of 5 clinical records reviewed. (Patient #5, 8, 9) The findings include: 1. Record review evidenced an agency policy revised 12/1/2021, titled "Plan of Care" which stated, "... Each patient has an individualized Plan of Care developed in consultation with the patient, physician or authorized practitioner, and staff ... Medications, treatments, and interventions are provided by qualified agency staff as ordered by the physician or authorized practitioner ...." 2. Clinical record review for Patient #5 was completed on 4/11/2023. Record review evidenced a plan of care for certification period 3/29/2023 - 5/27/2023, which indicated the skilled nurse was to change a dressing to a malignant back lesion twice weekly, and Entity #2 (mobile wound clinic) was to change the dressing 1 time weekly. During an interview on 4/11/2023, at 2:00 PM, Person #3 (employee of Entity #2) indicated Patient #5 was discharged on 3/22/2023, because a coccyx (area at base of spine) wound healed. Record review evidenced the patient only received 2 skilled nurse visits the week of 3/26/2023, and 1 skilled nurse visit the week of 4/2/2023. Record review failed to evidence the malignant back wound dressing was changed 3 times weekly as ordered on the plan of care. During an interview on 4/11/2023, at 10:39 AM, the Administrator indicated the patient should have received dressing care as was ordered on the plan of care. 3. Clinical record review for Patient #8 was completed on 4/11/2023. Record review evidenced a plan of care for certification period 1/31/2023 – 3/31/2023, which indicated the skilled nurse was to visit 1 time weekly for assessment of a right arm PICC line (peripherally inserted central catheter/intravenous line used for antibiotics). Record review evidenced a skilled nurse visit note dated 2/8/2023, which failed to include an assessment of the PICC line. During an interview on 4/10/2023, at 3:38 PM, the Administrator indicated the nurse should have completed a head-to-toe assessment, including an assessment of the PICC line site. 4. Clinical record review for Patient #9 was completed on 4/11/2023. Record review evidenced a plan of care for certification period 12/1/2022 – 1/29/2023, which indicated the patient was to receive skilled nurse visit 3 times weekly for 1 week, and 2 times weekly for 8 weeks, for instruction on TPN (total parenteral nutrition/nutrition through an IV) administration. The plan of care indicated the patient was to receive nightly TPN infusions through a PICC line (peripherally inserted central catheter/intravenous line for nutrition and antibiotics). Record review evidenced the patient discharged on 12/1/2022, from the hospital. Record review evidenced a skilled nurse start of care assessment dated 12/1/2022, which indicated Registered Nurse #3 educated the patient on TPN administration verbally. The visit note indicated the nurse administered an antibiotic by gravity during the visit. Record review evidenced a skilled nurse visit note dated 12/2/2022, which indicated the patient indicated they were unable to infuse the TPN on 12/1/2022, as ordered because the pump was malfunctioning. This visit note indicated that upon assessment, the bag was not spiked completely. The visit note indicated Registered Nurse #3 used handouts to educate the patient on TPN administration with the IV pump. The visit note failed to evidence the patient had return demonstrated TPN administration and setup of the infusion pump. Record review evidenced an on-call note dated 12/2/2022, at 9:11 PM, which indicated the patient was calling because the infusion pump was not working, and patient was unable to infuse the TPN. The on-call note indicated the patient requested a nurse come to their home to help them infuse the TPN, since they hadn’t received the prior night’s infusion either. The on-call visit note indicated the nurse told the patient the on call service was for triage only, and for over the phone troubleshooting. The on-call note indicated the nurse put in an as needed visit for the next day to assist the patient. Record review evidenced a skilled nurse visit note dated 12/3/2022, which indicated the Clinical Manager assisted the patient in setting up the IV pump, and the patient return demonstrated setup of the IV pump 2 times during the visit. During an interview on 4/10/2023, at 3:51 PM, the Administrator indicated the nurse should have coordinated a visit with the patient when it was time to set up the TPN for administration. The Administrator indicated the nurse should have had the patient return demonstrate the IV pump setup, and TPN administration. The Administrator indicated the nurse should have made a visit the night the patient called the on-call service, to assist with TPN administration.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review, and interview, the home health agency failed to ensure skilled professionals accurately prepared clinical notes and assessments in 5 of 10 clinical records reviewed (Patient #2, 5, 6, 7, 8). The findings include: 1. Record review evidenced a registered nurse job description obtained 4/11/2023, which stated, "... Essential Functions ... Documents patient visits thoroughly and completely per policy and payer requirements ...." 2. Record review evidenced an agency policy revised 3/1/2022, titled "Patient Assessment, Initial and Reassessment" which stated, "... Upon admission and reassessment, the qualified clinician performs the following assessment activities and collects the following data: ... Integumentary status ... Respiratory status ... Elimination status ...." 3. Clinical record review for Patient #5 was completed on 4/11/2023, for certification period 3/29/2023 - 5/27/2023. Record review evidenced a recertification comprehensive assessment dated 3/24/2023, which stated, "... No lesions 2+3d3ma ...." The comprehensive assessment failed to include a lung sound assessment. The comprehensive assessment indicated the patient had a urostomy (tube inserted into the bladder to drain urine), and failed to include an assessment of the urostomy site, or urine. The comprehensive assessment indicated the patient was diabetic (problem regulating blood sugars), but failed to include the patient's blood glucose measurement. Record review evidenced a plan of care for certification period 3/29/2023 - 5/27/2023, which indicated the patient had a nephrostomy (tube inserted into kidney to drain urine). The plan of care indicated the patient was to receive daily blood glucose checks, and assessments of nephrostomy tube sites every visit. Record review evidenced a skilled nurse visit note dated 3/31/2023, which failed to include a blood glucose measurement. This visit note also failed to include a nephrostomy tube assessment. This visit note indicated the patient had trace edema (swelling), but failed to identify the location of the swelling. This visit note also indicated the patient did not have diabetes. Record review evidenced a skilled nurse visit dated 4/7/2023, which indicated the patient had developed a new wound under the nephrostomy tube site, but failed to include an assessment of the wound, or measurements. During an interview on 4/11/2023, at 10:26 AM, the Administrator indicated the recertification assessment was documented in error. The Administrator indicated the comprehensive assessment should have included an assessment of lung sounds. The Administrator indicated the nurse should have documented nephrostomy tube on the comprehensive assessment and included an assessment of the site and urine. The Administrator indicated any patient with diabetes should have blood glucose measurements included on all visit notes. At 10:34 AM, the Administrator indicated the nurse should have included an assessment on the 3/31/2023, visit note of the nephrostomy tubes. At 10:34 AM, the Administrator indicated the 3/31/2023, visit note should have indicated the location of edema, and that the patient did have diabetes. The Administrator indicated any new wound should have included a documented assessment and wound measurements. 4. Clinical record review for Patient #6 was completed on 4/11/2023, for certification period 3/20/2023 - 5/18/2023. Record review evidenced a start of care comprehensive assessment dated 3/20/2023, which indicated the patient wore oxygen, but failed to include lung sounds in the respiratory assessment, or heart sounds in the cardiac assessment. During an interview on 4/10/2023, at 3:07 PM, the Administrator indicated the comprehensive assessment should have included lung and heart sounds. 5. Clinical record review for Patient #7 was completed on 4/11/2023, for certification period 2/19/2023 - 4/19/2023. Record review evidenced a skilled nurse visit note dated 3/20/2023, which indicated wound care was provided, but also indicated the patient had no wounds because they were healed. During an interview on 4/10/2023, at 3:28 PM, the Administrator indicated the documentation was inaccurate and shouldn't have had wound care provided to a healed wound. 6. Clinical record review for Patient #8 was completed on 4/11/2023. Record review evidenced a plan of care for certification period 1/31/2023 – 3/31/2023, which indicated the skilled nurse was to visit 1 time weekly for assessment of a right arm PICC line (peripherally inserted central catheter/intravenous line used for antibiotics). Record review evidenced a skilled nurse visit note dated 2/8/2023, which failed to include an assessment of the PICC line. During an interview on 4/10/2023, at 3:38 PM, the Administrator indicated the nurse should have completed a head-to-toe assessment, including an assessment of the PICC line site. 7. Clinical record review for patient #2 was completed on 4/11/2023. Record review evidenced a comprehensive reassessment dated 3/22/2023. The document evidenced the patient had a wound on the left heel; the patient was paraplegic (paralyzed with absence of sensation from the waist down, and inability to control bowel or bladder), but then indicated the patient had no sensory deficit which would limit ability to feel or voice pain, and skin was rarely exposed to moisture; gastrointestinal assessment findings included only bowel sounds, but failed to indicate if the patient used an effective bowel program or was incontinent; the patient had a suprapubic urinary catheter (a tube inserted from a surgical opening in the lower abdomen into the bladder); and the nurse removed the old urinary catheter, cleansed the perineal area (skin between genitals and anus), and inserted a new urinary catheter. Record review evidenced a coordination note dated 3/7/2023, which indicated the patient had a foley catheter (inserted into the urethra), not a suprapubic catheter. Record review evidenced a wound record report, which evidence the patient's right heel wound was resolved on 10/20/2022, and evidenced presence of a current wound to the left heel (onset date 9/26/2022). Record review evidenced a team case conference/coordination note dated 3/08/2023, which evidenced skilled nursing to continue management of wound care to right heel, and right heel was making good progress. Record review evidenced a team case conference/coordination note dated 3/15/2023, which evidenced care to be continued for care of nephrostomy tubes (thin plastic tube inserted in the back of the body, through the skin, and then into the kidney). On 4/11/2023 at 2:18 PM, when informed of the documented discrepancies in the clinical record, the Administrator closed her eyes, shook her head left to right, and then indicated she couldn't believe it, and confirmed the patient's perineal area wouldn't be cleansed to insert a suprapubic catheter.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 1/23/2023, 1/24/2023, 1/25/2023, 1/26/2023, 1/27/2023, 1/30/2023, 1/31/2023, 2/1/2023, and 2/2/2023 Facility ID: IN005259

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure patients received an individualized emergency preparedness plan as part of the comprehensive assessment in 5 of 7 home visits conducted. (#1, 2, 4, 5, 6) The findings include: 1. Record review evidenced an agency policy revised 3/1/2022, titled “Patient Assessment, Initial, and Reassessment” which stated, “… Upon admission and reassessments, the qualified clinician performs the following assessment activities and collects the following data: … Emergency disaster plan ….” 2. Observation of a home visit for Patient #1 was completed on 1/25/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s home binder was reviewed. The home binder included an emergency plan which indicated the evacuation location was the nearest hotel, but failed to be individualized to specify which hotel, or include an address. During an interview on 1/31/2023, at 9:48 AM, administrator/clinical manager #1 indicated each patient should have had a personalized plan for where specifically they would evacuate to if they needed to leave their home. 3. Observation of a home visit for Patient #2 was conducted on 1/25/2023, at 10:00 AM, to observe a routine skilled nurse visit. During the visit, the patient’s home binder was reveiwed. The home binder included an emergency plan which indicated the evacuation location was the nearest hotel, but failed to be individualized to specify which hotel, or include an address. 4. Observation of a home visit for Patient #4 was conducted on 1/27/2023, at 10:15 AM, to observe a routine skilled nurse visit. During the visit, the patient’s home health binder was reviewed. This binder included an emergency plan which indicated the evacuation location was the nearest hotel, but failed to be individualized to specify which hotel, or include an address. 5. Observation of a home visit for Patient #5 was conducted on 1/27/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s home health binder was reviewed. This binder failed to include an emergency preparedness plan. 6. Observation of a home visit for Patient #6 was conducted on 1/30/2023, at 4:00 PM, to observe a routine physical therapy visit. During the visit, the patient’s home health binder was reviewed. This binder included an emergency plan which indicated the evacuation location was the fire department, but failed to be individualized to specify the address of the fire department.

This visit was for a Federal Recertification and State Re-licensure survey. Facility ID: IN005259 Survey Dates: 1/23/2023, 1/24/2023, 1/25/2023, 1/26/2023, 1/27/2023, 1/30/2023, 1/31/2023, 2/1/2023, and 2/2/2023. Census: 184 Indiana Homecare Northwest, is precluded from providing its own home health aide training and competency evaluation for a period of two years from 2/2/2023 - 2/1/2024, due to being found out of compliance with Conditions of Participation: 42 CFR 484.55 Comprehensive assessment of patients and 42 CFR 484.60 Care Planning, Coordination of Care and Quality of Care. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Quality Review Completed 02/16/2023

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the OASIS (Outcome and Assessment Information Set) data was inaccurate for 6 of 17 clinical records reviewed (#12, 13, 14, 15, 16, 17). Findings include: 1. An agency policy with revised date 1/01/15, titled "OASIS Accuracy Review", stated, "... Policy ... To enhance and validate accuracy of OASIS ...." 2. Clinical record review for patient #12 was completed on 2/01/23 (start of care date 1/18/23, certification period 1/18/23 – 3/18/23). A document dated and signed by Person #1 on 1/13/23, titled “Referral Order” evidenced the agency received a referral for homecare services on 1/13/23. A document dated 10/04/22, titled “Visit Note Report” (PT start of care comprehensive assessment with OASIS [Outcome and Assessment Information Set]) evidenced the OASIS item M0104 (date of referral) was documented as 1/17/23. The OASIS data was inaccurate. During an interview on 2/01/23 at 11:18 AM, the Administrator confirmed the referral date was 1/13/23, and indicated she didn’t know why the PT documented 1/17/23 as the referral date. 3. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 10/04/22 – 12/02/22). A document dated and signed by Person #28 on 9/29/22, titled “Referral Order” evidenced the agency received a referral for homecare services on 9/29/22. The document failed to evidence the physician ordered a specific start of care date. A document dated 10/04/22, titled “Visit Note Report” (PT start of care comprehensive assessment with OASIS [Outcome and Assessment Information Set]) evidenced the OASIS item M0104 (date of referral) was documented as 10/03/22. The OASIS data was inaccurate. During an interview on 2/02/23 at 2:33 PM, the Administrator confirmed the referral date was 9/29/22, and indicated she didn’t know why the PT documented 10/03/22 as the referral date. 4. Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document dated 10/17/22, titled “[Entity #25, a skilled nursing facility]” evidenced the agency received a referral for homecare services on 10/17/22. The document failed to evidence the physician ordered a specific start of care date. A document dated 10/27/22, titled “Visit Note Report” (PT start of care comprehensive assessment with OASIS [Outcome and Assessment Information Set]) evidenced the OASIS item M0102 (date of physician-ordered start of care is known) was documented as “yes”, and M0102 (date of physician-ordered start of care) was documented as 10/27/22. The OASIS data was inaccurate. During an interview on 2/02/23 at 3:01 PM, the Administrator indicated there wasn’t a specific start of care date ordered by the physician. 5. Clinical record review for patient #15 was completed on 2/02/23. A document titled “[Entity #21, an orthopedic facility] evidenced the agency received a referral for homecare services on 1/11/23. The document failed to evidence the physician ordered a specific start of care date. A document dated 11/13/22, titled “Visit Note Report” (PT start of care comprehensive assessment with OASIS [Outcome and Assessment Information Set]) evidenced the OASIS item M0102 (date of physician-ordered start of care is known) was documented as “yes”, and M0102 (date of physician-ordered start of care) was documented as 1/13/23. The OASIS data was inaccurate. During an interview on 2/02/23 at 3:30 PM, the Administrator indicated there was not a specific date ordered by the physician for the start of care. 6. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document dated 11/14/22, titled “[Entity #15, a hospital]” evidenced the agency received a referral for home care services from Entity #15 on 11/14/22. A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment with OASIS [Outcome and Assessment Information Set]) evidenced the OASIS item M0104 (date of referral) was 11/19/22. The OASIS data was inaccurate. During an interview on 2/01/23 at 2:15 PM, the Administrator indicated she didn’t know why the physical therapist documented the referral date as 11/19/22 on the comprehensive assessment. 7. Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document dated and signed by Person #7 (the patient’s certifying physician) on 7/05/22, titled “Referral Order”, stated, “... Home Health Referral ... need SN [skilled nurse], PT [physical therapy], and OT [occupational therapy] ....” The referral document was dated 7/05/22 in the patient’s EMR. A document dated 7/08/22, titled “Visit Note Report” (PT start of care comprehensive assessment with OASIS [Outcome and Assessment Information Set]) evidenced the OASIS item M0104 (date of referral) was documented as 7/07/22. The OASIS data was inaccurate. During an interview on 2/02/23 at 3:45 PM, the Administrator confirmed the referral date was 7/05/22, indicated she wasn’t sure why 7/07/22 was documented as the referral date, it was possibly a documentation error, and the EMR didn’t evidence the referral date was changed.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to: ensure the initial assessment visit was held within 48 hours of referral, the patient’s return home, or on the physician ordered start of care date (see tag G514); ensure the comprehensive assessments included the patient’s current health, psychosocial, functional, and/or cognitive status (see tag G528); complete a review of all medications the patient was currently using in order to identify potential drug interactions, duplicative drug therapy, and/or noncompliance with drug therapy (see tag G536); ensure the comprehensive assessment was updated when there was a major decline in status (see tag G544); and ensure a comprehensive assessment was completed within 48 hours of discharge and return home (see tag G548). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition of participation: 42 CFR 484.55 Comprehensive assessment of patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the registered nurse completed the initial assessment visit within 48 hours of referral, within 48 hours of the patient’s return home, or on the physician ordered start of care date in 7 of 17 clinical records reviewed. (#5, 8, 12, 13, 14, 16, 17). The findings include: 4. Clinical record review for patient #12 was completed on 2/01/23 (start of care date 1/18/23, certification period 1/18/23 – 3/18/23). A document dated and signed by Person #1 (the patient’s certifying physician) on 1/13/23, titled “Referral Order” evidenced the agency received a referral for homecare services on 1/13/23. A document dated 1/18/23, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the initial evaluation was completed on 1/18/23, which was greater than 48 hours (5 days) after the agency received the referral. The EMR failed to evidence why the patient’s initial evaluation was delayed. During an interview on 1/26/23, Patient #12 indicated she didn’t request a delay in services, and the PT just called her to tell her when he was coming. During an interview on 2/01/23 at 11:18 AM, the Administrator indicated the clinical record didn’t show if the patient requested a later start of care date. 5. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 10/04/22 – 12/02/22). A document dated and signed by Person #28 (the patient’s certifying physician) on 9/29/22, titled “Referral Order” evidenced the agency received a referral for homecare services on 9/29/22, and included orders for PT, OT, and skilled nursing. A document dated 10/27/22, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the initial evaluation was completed on 10/04/22, which was greater than 48 hours (5 days) after the agency received the referral. The EMR failed to evidence why the patient’s initial evaluation was delayed. During an interview on 2/02/23 at 2:33 PM, the Administrator indicated she didn’t know why there was a delay in the start of care. 6. Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document titled “[Entity #25, a skilled nursing facility] evidenced the agency received a referral for homecare services on 10/17/22. A document dated 10/27/22, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the initial evaluation was completed on 10/27/22, which was greater than 48 hours (10 days) after the agency received the referral. The EMR failed to evidence why the patient’s initial evaluation was delayed. During an interview on 2/02/23 at 3:01 PM, the Administrator indicated she didn’t know why services were delayed. 7. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document with printed date 11/14/22, titled “History and Physical Report”, indicated the patient was admitted at Entity #15 (a hospital) on 11/04/22, and discharged on 11/08/22. A document dated 11/14/22, titled “[Entity #15]” evidenced the agency received a referral for home care services from Entity #15 on 11/14/22. A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the initial evaluation was completed on 11/20/22, which was greater than 48 hours (6 days) after the agency received the referral. The EMR failed to evidence why the patient’s initial evaluation was delayed. During an interview on 2/01/23 at 2:15 PM, the Administrator stated, “... the patient must have been somewhere between hospital discharge on the 8th [11/08/22] and when we admitted her on the 20th [11/20/22] ....” 8. Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document dated and signed by Person #7 (the patient’s certifying physician) on 7/05/22, titled “Referral Order”, stated, “... Home Health Referral ... need SN [skilled nurse], PT [physical therapy], and OT [occupational therapy] ....” A document dated 7/08/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the initial evaluation was completed on 7/08/22, which was greater than 48 hours (3 days) after the agency received the referral. The EMR failed to evidence why the patient’s initial evaluation was delayed. During an interview on 2/02/23 at 3:45 PM, the Administrator confirmed the referral date was 7/05/22, the initial evaluation occurred greater than 48 hours after the referral was received by the agency, and the EMR didn’t evidence the referral date changed. 9. During an interview on 2/01/23 at 11:04 AM, the Administrator indicated the initial evaluation was completed in conjunction with the initial comprehensive assessment. 1. Record review evidenced an agency policy revised 1/1/2023, titled “Admission Process” which stated, “… admission/initial visits are made within 48 hours from referral unless there is a specific physician ordered start of care date which would supersede the state established timeframes ….” 2. Clinical record review for Patient #5 was completed on 2/2/2023, for certification period 8/28/2022 – 10/26/2022. Record review evidenced a referral order dated 8/24/2022, which indicated the patient was to receive home health services. Clinical record review evidenced a start of care, initial assessment dated 8/28/2022 (4 days after referral). During an interview on 1/31/2023, at 12:33 PM, administrator/clinical manager #1 indicated they did not know why the start of care was 4 days after the referral order was received. Administrator/clincial manager #1 indciated patients should receive initial assessment visits within 48 hours of referral, unless the physician specified otherwise. 3. Clinical record review for Patient #8 was completed on 2/2/2023, for certification period 1/5/2023 – 3/5/2023. Record review evidenced a referral order dated 12/26/2023, which indicated the patient was to discharge home on 12/26/2023, and receive home health services. Clinical record review evidenced an initial assessment dated 1/5/2023 (10 days after referral). During an interview on 1/30/2023, at 2:58 PM, administrator/clinical manager #1 indicated they did not know why the initial assessment was delayed. 410 IAC 17-14-1(a)(1)(A)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the comprehensive assessment included a review of all medications the patient was using to identify potential adverse effects, including ineffective drug therapy, significant side effects, significant drug interactions, duplicative drug therapy, and/or noncompliance with drug therapy; and/or failed to ensure the drug regimen review was conducted by a registered nurse in 13 of 17 clinical records reviewed. (#1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17) The findings include: 10. Clinical record review for patient #12 was completed on 2/01/23 (start of care date 1/18/23, certification period 1/18/23 – 3/18/23). A document dated and signed by Person #1 (the patient’s certifying physician) on 1/13/23, titled “[Patient’s name and identifying information]” evidenced the patient’s current medications included calcium citrate 2400 mg twice daily (a supplement), Epipen (for the emergency treatment of life-threatening allergic reactions), fiber capsules (for gut health/soft stools), gas-x (reduce gas), multaq- take twice daily with breakfast and dinner (to treat cardiac arrhythmias) probiotic daily (gut health), Topamax (used to treat epilepsy and prevent migraines), vitamin D3 5000 units daily (supplement), and warfarin (blood thinner) 5 mg daily except Thursday- take 7.5 mg. A document titled “Home Health Certification and Plan of Care” (for certification period 1/18/23 – 3/23/23), evidenced the patient’s medications included diazepam (prescribed to treat insomnia for this patient), calcium citrate plus 250 mg-40 mg-125 Unit-3.75 mg tablet 3 times daily (the current order was calcium citrate 2400 mg twice daily), warfarin 5 mg every morning (the current order was warfarin 5 mg daily except Thursday- take 7.5 mg), and Vitamin D3 2,000 Units every morning (the current order was Vitamin D3 5000 units daily); indicated multaq was a supplement (multaq is used to treat cardiac arrhythmias); failed to evidence the patient’s current medications also included fiber capsules, gas-x, a probiotic, and Topamax; and failed to include indication for multaq to be taken twice daily with breakfast and dinner. A document dated 1/17/23, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the PT reviewed the patient’s medications, and performed a drug regimen review, and stated, “... Was patient instructed on special precautions ... Yes ... which medications were instructed on ... Warfarin ....” During an interview on 2/01/23 at 11:18 AM, the Administrator indicated the PT reviewed the medications and performed a drug regimen review. When queried how the PT knew which medications were “high risk”, the Administrator indicated the agency had a “tip list” they could refer to, and there was also patient education access for each medication right in the EMR, and the PT should have addressed the diazepam as a high-risk drug (due to abuse potential and risk for physical and psychological dependence). 11. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/04/22 - ), evidenced the patient’s medications included allopurinol (to treat gout), amiodarone (to treat life-threatening heart rhythm problems), carvedilol (to treat high blood pressure and heart failure), Eliquis (a blood thinner), furosemide (a diuretic), and glimepiride (to treat diabetes). The plan of care failed to evidence the indications for use of allopurinol, amiodarone, carvedilol, Eliquis, furosemide, or glimepiride. A document dated 10/04/22, titled “Visit Note Report” (PT comprehensive assessment) evidenced the PT reviewed the patient’s medications, performed a drug regimen review, and stated, “... Was patient instructed on special precautions ... Yes ... which medications were instructed on ... Eliquis ....” The document failed to evidence the patient was instructed on the 3 potential major drug interactions between amiodarone and furosemide, allopurinol and lisinopril, an lisinopril and potassium chloride. Review of a web base drug interaction checker on 2/01/23, titled “Drugs.com” (https://www.drugs.com/interactions-check.php?drug_list=127-0,167-0,276-0,1665-16414,531-0,3438-16026,1146-0,1176-0,1476-0,1912-0,3322-15296,1003-5789), evidenced the patient’s medications included 3 major drug interactions (highly clinically significant, avoid combinations, and the risk of the interaction outweighs the benefit). Use of amiodarone together with furosemide can increase the risk of an irregular heart rhythm that may be serious. Use of allopurinol together with lisinopril may increase the risk of severe allergic reactions and infections. Use of lisinopril together with potassium chloride may significantly increase potassium levels in the blood, and high levels of potassium can lead to kidney failure, muscle paralysis, irregular heart rhythm, and cardiac arrest. A document titled “Home Health Certification and Plan of Care” (for certification period 12/03/22 – 1/31/23), evidenced the patient’s medications included allopurinol, amiodarone, carvedilol, Eliquis, furosemide, and glimepiride. The plan of care failed to evidence the indications for use of allopurinol, amiodarone, carvedilol, Eliquis, furosemide, or glimepiride. During an interview on 2/02/23 at 2:33 PM, the Administrator indicated the PT reviewed the patient's medications and performed the drug regimen review. 12. Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document dated 10/14/22, titled “[Entity #25, a skilled nursing facility] ... Progress Notes”, evidenced the patient’s lung sounds improved with crackles (sounds heard when the small air sacs in the lungs fill with fluid and there's air movement in the sacs during breathing) since she was started on Lasix (a diuretic). A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/27/22 – 12/25/22) evidenced the patient’s medication profile included cephalexin (an antibiotic), colace (docusate) (a stool softener), gabapentin (a controlled substance to treat nerve pain), and continuous oxygen at 4 liters per minute (LPM) via nasal cannula (small tubes inserted into the nostrils to administer oxygen). The plan of care failed to evidence indications for use of cephalexin, colace, or gabapentin; and failed to evidence the patient took Lasix. A document dated 10/27/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the PT reviewed the patient’s medications and performed a drug regimen review, and the patient used oxygen at 2 LPM. The document failed to evidence the patient’s correct dose of O2 was 4 LPM. A document dated 11/03/22, titled “Visit Note Report” (PTA routine visit), evidenced the patient used O2 at 3 LPM, the patient used O2 at 6.5 LPM. The document failed to evidence the patient’s correct dose of O2 was 4 LPM. An additional document dated 11/03/22, titled “Visit Note Report” (RN add-on evaluation), evidenced the patient’s O2 saturation (amount of O2 in the blood) was assessed while the patient wasn’t wearing O2, and then indicated the patient used O2 at 3 LPM. A document dated 11/08/22, titled “Visit Note Report” (PTA routine visit), evidenced the patient’s O2 saturation (amount of O2 in the blood) was assessed while the patient wasn’t wearing O2, and then indicated the patient used O2 at 3 LPM. During an interview on 2/02/23 at 3:01 PM, the Administrator indicated the inaccurate documentation of the patient’s oxygen doses were considered medication errors. 13. Clinical record review for patient #15 was completed on 2/02/23. A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s medication profile included tylenol with codeine (a narcotic/opioid pain medication) amlodipine (to treat high blood pressure), citalopram (an antidepressant), levetiracetam (an anti-seizure medication), and Synthroid (to treat thyroid hormone deficiency). The plan of care failed to evidence indications for use of amlodipine, citalopram, levetiracetam, or Synthroid. A document dated 11/13/22, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the PT reviewed the patient’s medications, performed a drug regimen review, and stated, “... Was patient instructed on special precautions ... on all high-risk medications ... Yes ... which medications were instructed on ... opioid [a narcotic pain medication] ... constipation risk ....” The document failed to evidence the patient was instructed on the potential for addiction to an opioid medication, or instructed on levetiracetam (a high-risk medication). During an interview on 2/02/23 at 3:30 PM, the Administrator indicated the PT reviewed the patient’s medications and performed the drug regimen review, levetiracetam was a high-risk medication, and the PT did not provide instruction on the medication. 14. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s medication profile included allopurinol (to treat gout), amiodarone (to treat life-threatening heart rhythm problems), aspercreme (lidocaine hydrochloride [HCL]) 4% topical patch daily to lower back (pain relief), Eliquis (a blood thinner/anticoagulant), epogen injections 3 times weekly at dialysis (to treat amemia, or low red blood cell count), Jakafi (used for treatment of myelofibrosis, a rare type of blood cancer that causes scar tissue to form in bone marrow), midodrine (to treat orthostatic hypotension, or a sudden drop in blood pressure when changing positions from sitting to standing) as directed/as needed at dialysis, mirtazapine (an antidepressant), ondansetron as needed for nausea, and tramadol (moderate to severe pain relief). The plan of care failed to evidence indications for use of allopurinol, amiodarone, aspercreme (lidocaine HCL) 4% topical patch, Eliquis, epogen injections, Jakafi, midodrine, or mirtazapine. Review of a web base drug interaction checker on 2/01/23, titled “Drugs.com” (https://www.drugs.com/interactions-check.php?drug_list=127-0,167-0,1465-18047,3438-16026,2365-487,998-545,3352-15486,1424-0,1629-0,1640-0,1752-0,1665-16509,1661-19134,2221-0,11-12) evidenced the patient’s medications included 7 major drug interactions (highly clinically significant, avoid combinations, and the risk of the interaction outweighs the benefit). Use of amiodarone together with ondansetron can increase the risk of an irregular heart rhythm that may be serious and potentially life-threatening; use of amiodarone together with tramadol can increase the risk of an irregular heart rhythm that may be serious and potentially life-threatening; combined use of ondansetron and tramadol can increase the risk of serotonin syndrome and an irregular heart rhythm, both rare but potentially life-threatening effects of these drugs, and serotonin syndrome may include symptoms such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea. Severe cases may result in coma and even death; use of amiodarone together with mirtazapine can increase the risk of an irregular heart rhythm that may be serious and potentially life-threatening; use of ondansetron together with mirtazapine can increase the risk of a rare but serious condition called serotonin syndrome; use of tramadol together with mirtazapine can increase the risk of a rare but serious condition called serotonin syndrome; and use of apixaban (Eliquis) together with ruxolitinib (Jakafi) may increase the risk of bleeding, including severe and sometimes fatal hemorrhage. A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the PT reviewed the patient’s medications, performed a drug regimen review, and stated, “... Was patient instructed on special precautions ... Yes ... which medications were instructed on ... Eliquis ....” The document failed to evidence the patient was instructed on the 7 potential major drug interactions between amiodarone and ondansetron, amiodarone and tramadol, ondansetron and tramadol, amiodarone and mirtazapine, ondansetron and mirtazapine, tramadol and mirtazapine, or apixaban (Eliquis) and ruxolitinib (Jakafi). A document received from Entity #16 on 1/27/23, titled “Home Medication”, evidenced a list of medications the patient took for date range 10/31/22 – 11/26/22, which included albuterol nebulizer solution to be inhaled every 4 hours as needed for shortness of breath, midodrine 10 mg (milligrams) by mouth twice daily for hypotension (low blood pressure), and mirtazapine (Remeron) was to be taken every night at bedtime. The patient’s plan of care/medication profile failed to evidence the patient used albuterol; the patient’s medication profile incorrectly indicated midodrine was used only as directed/as needed at dialysis, and the patient’s medication profile failed to evidence mirtazapine was to be taken every night at bedtime. During an interview on 2/01/23 at 2:15 PM, the Administrator indicated the PT reviewed the patient’s medications and performed the drug regimen review, did not instruct on all high risk medications/ special precautions, and there was no coordination with Entity #16. 15. Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document titled “Home Health Certification and Plan of Care” (for certification period 7/08/22 – 9/05/22), evidenced the patient’s medication profile included atorvastatin (to treat high cholesterol), biotin (a vitamin B supplement), Jakafi (used for treatment of myelofibrosis, a rare type of blood cancer that causes scar tissue to form in bone marrow), magnesium (supplement), pantoprazole (reduces the amount of acid your stomach makes), tolterodine (used treat overactive bladder), topiramate (used to treat epilepsy and prevent migraines), Vitamin B complex and Vitamin D3 (both supplements). The medication profile failed to include indications for use of atorvastatin, biotin, Jakafi, magnesium, pantoprazole, tolterodine, topiramate, Vitamin B complex or Vitamin D3. An untitled document with order date 7/26/22 (a physician’s order), evidenced the patient was prescribed metolazone (used to reduce the swelling and fluid retention caused by congestive heart failure or kidney disease) to be taken for 3 days. The document failed to indicate why the medication was prescribed. During an interview on 2/02/23 at 3:45 PM, the Administrator indicated the PT reviewed the patient’s medications and performed the drug regimen review, and the patient’s medication profile should include indications for use. 1. Record review evidenced an agency policy revised 3/1/2022, titled “Patient Assessment, Initial, and Reassessment” which stated, “… Upon admission and reassessments, the qualified clinician performs the following assessment activities and collects the following data: … Review of all medications patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy ….” 2. Record review evidenced an agency policy revised 5/1/2019, titled “Monitoring Medications” which stated, “… For therapy only patients, the Patient Care Manger will review the comprehensive medication list formulated by the therrapist and complete the drug regimen review which is documented in the medical record ….” 3. Observation of a home visit for Patient #1 was conducted on 1/25/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles were reviewed. Review evidenced the following medciations which were not included on the medication profile, or reviewed during the comprehensive assessment: ibuprofen (for fever or pain), topiramate (to prevent seizures), and sertraline 100 milligrams twice daily. Clinical record review for Patient #1 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a medication profile last reviewed on 1/7/2023, which included the following medications the patient was not taking: acetaminophen (for fever/pain), and modafinil (to help stay alert/awake). During an interview on 1/31/2023, at 9:41 AM, administrator/clinical manager #1 indicated the medications profile was completed during the comprehensive assessment, and should have included all medciations the patient was taking. 4. Observation of a home visit for Patient #2 was conducted on 1/25/2023, at 10:00 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles were reviewed. Review evidenced the following medications which were not included on the medication profile, or reviewed during the comprehensive assessment: iron (supplement), vitamin B12, and folic acid (supplement). Clinical reccord review for Patient #2 was completed on 2/2/2023, for certification period 11/30/2022 – 1/28/2023. Record review evidenced a medication profile dated 12/28/2023, which included lactase (for lactose intolerance), which the patient was not taking. 5. Observation of a home visit for Patient #3 was conducted on 1/26/2023, at 10:00 AM, to observe a routine occupational therapy visit. During the visit, the patient’s medication bottles were reviewed. Review evidenced ciprofloxacin (antibiotic) and tramadol (for pain) 1 time daily as needed for pain, which were not included on the medication profile, or reviewed during the comprehensive assessment. Record review evidenced a medication profile dated 12/8/2022, which included the following medications the patient was not taking: aspirin (to prevent stroke and heart attack), benzonatate (for cough), tizanidine (muscle relaxer), and tramadol 50 milligrams every 4 hours as needed for pain. 6. Observation of a home visit for Patient #4 was conducted on 1/27/2023, at 10:15 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles were reviewed. Review evidenced the following medication bottles which were not included on the medication profile as part of the comprehensive assessment: ipratropium bromide nasal spray (for runny nose) and ibuprofen (for pain). 7. Observation of a home visit for Patient #5 was conducted on 1/27/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles were reviewed. Review evidenced the following medication bottles which were not included on the patient’s medication profile as part of the comprehensive assessement: oxycodone-acetaminophen (pain medication) 10-325 milligrams every 6 hours as needed for pain, pepcid (antacid), baclofen (muscle relaxer) 10 milligrams twice daily, and probiotic (to improve diarrhea). Clinical record review evidenced a medicatin profile dated 12/16/2022, which included acetaminophen (for pain/fever), which the patient was not taking. 8. Observation of a home visit for Patient #6 was completed on 1/30/2023, at 4:00 PM, to observe a routine physical therarpy visit. During the visit, the patient’s medication bottles were reviewed. Review evidenced the patient was taking flomax (for enlarged prostate) 0.4 milligrams twice daily and atorvastatin 10 milligrams twice daily. Clinical record review for Patient #6 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a medicatin profile, which indicated the patient was taking flomax 0.4 milligrams once daily, and atorvastatin 10 milligrams once daily. Clinical record review evidenced a start of care assessment dated 1/10/2023, which was completed and signed by physical therapist #1. This start of care assessment indicated the physical therapist had reviewed the patients medications for significant side effects, drug interactions, duplicate drug therapy, and compliance with drug therapy. Record review failed to evidence the registered nurse reviewed the patient’s medications during the comprehensive assessment. During an interview on 1/23/2023, at 9:49 AM, administrator/clinical manager #1 indicated in therapy only cases, the patient care manager should have completed the drug regimen review, not the therapist. 9. Clinical record review for Patient #8 was completed on 2/2/2023, for certification period 1/5/2023 – 3/5/2023. Record review evidenced a start of care assessment completed by a physical therapist on 1/5/2023. This start of care assessment indicated the physical therapist had reviewed the patients medications for significant side effects, drug interactions, duplicate drug therapy, and compliance with drug therapy. Record review failed to evidence the registered nurse reviewed the patient’s medications during the comprehensive assessment. 410 IAC 17-14-1(a)(1)(B)

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the comprehensive assessment was updated in 4 of 4 clinical records reviewed where a major decline in the patient’s health status occurred (#9, 13, 14, 16). The findings include: 3. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 12/03/22 – 1/31/23). A document dated 12/06/22, titled “Visit Note Report” (PTA routine visit) evidenced the patient reported no pain. A document dated 12/08/22, titled “Visit Note Report” (PTA routine visit), evidenced the patient had no pain, and no falls occurred since the last routine visit. A document titled “Risk Management Total Incident Summary Report ....”, event date 12/07/22, stated, “... Patient fell early last week in bathroom. Patient bruised toes on left foot ... edema and pain ... Emergency services called and patient went to E.R. [emergency room] ... Care Plan [plan of care] reviewed/revised ....” The clinical record failed to evidence a comprehensive assessment with OASIS data occurred after the agency became aware of the fall with injury that required emergent care. A document dated 12/13/22, titled “Visit Note Report” (PT Reassessment without OASIS data set), evidenced the patient reported pain as “5” (on a scale of 0-10, with 0=no pain and 10= worst pain possible), and stated, “... Patient reports she twisted her right knee while getting in and out of a vehicle on Saturday [12/10/22] ... has been experiencing significant pain with the right knee area ever since ... does not want to go to the emergency room ... she is now using the wheelchair for most mobility ... unable to safely use walker ....” The clinical record failed to evidence a comprehensive assessment with OASIS data occurred after the agency became aware of the fall with injury that required emergent care. A document dated 12/19/22, titled “Visit Note Report” (PTA routine visit) indicated the patient’s right knee remained painful at a “6”, and she was going Wednesday (12/21/22) to have it checked out (no further information). The clinical record failed to evidence a comprehensive assessment with OASIS data occurred. A document dated 12/27/22, titled “Visit Note Report” (PT reassessment without OASIS data) indicated the patient used over the counter and prescription medications for pain relief, the patient’s fear of falling was a high concern, and stated, “... Patient reports she did have a consult ortho [orthopedic] due to right knee pain ... ortho suspects a fracture ... continued pain ... difficult time getting around ... occasional assistance ....” The clinical record failed to evidence a comprehensive assessment with OASIS data occurred, or what medications the patient took. A document dated 1/02/23, titled “Visit Note Report” (PTA routine visit) stated, “... Patient ... has MRI tomorrow for [right] knee ... mentions ... having an aide come today to help with shower and cleaning of home ... presents [with] right knee brace on ... was not on appropriately ....” The clinical record failed to evidence a comprehensive assessment with OASIS data occurred. A document dated 1/12/23, titled “Visit Note Report” (PTA routine visit) stated, “... Patient had [physician] appointment Tuesday [1/10/23] with [Person #29, an orthopedic physician] ... [patient to] wear [right] knee brace for two weeks then begin [outpatient] therapy ... remain [non-weight bearing right lower leg] ... has a fracture ....” The clinical record failed to evidence a comprehensive assessment with OASIS data occurred. During an interview on 2/02/23 at 2:33 PM, the Administrator indicated the patient should have been reassessed, the aide wasn’t from their agency, and she didn’t know who it was. 4. Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document dated 10/17/22, titled “... Order Category: Dietary, Pharmacy ... Active Orders As Of ... 10/17/22”, evidenced the document originated from Entity #25 (a skilled nursing facility). The document listed the patient’s current diagnoses, which included unspecified dementia (loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life), obstructive and reflux uropathy (a disorder of the urinary tract that occurs due to obstructed urinary flow), UTI, dysphagia, oropharyngeal phase (difficulty initiating a swallow, and swallowing may be accompanied by regurgitation, aspiration [the drawing in of a foreign substance into the lungs], and a sensation of residual food remaining in the throat), and other symptoms and signs concerning food and fluid intake. A document dated 10/14/22, titled “[Entity #25] ... Progress Notes”, evidenced the patient’s lung sounds improved with crackles (sounds heard when the small air sacs in the lungs fill with fluid and there's air movement in the sacs during breathing) since she was started on Lasix (a diuretic), and family had an appointment with Entity #27 (an oxygen and medical equipment company) for training on BiPap (a device that helps with breathing, and forces intermittent air into the lungs). A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/27/22 – 12/25/22), evidenced the patient’s primary diagnosis was acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and additional diagnoses included pneumonitis due to inhalation of food and vomit (an infection of the lungs caused by inhaling saliva, food, liquid, vomit and even small foreign objects into the lungs [aspiration]), dementia, and dependence on supplemental oxygen; and medications included oxygen at 4 LPM via nasal cannula (tubes inserted into the nose). A document dated 10/27/22, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced assessment findings, which indicated the patient was alert and oriented to person, place, and time; had no cardiovascular (heart/circulatory) problems, the only respiratory issue was the use of O2 at 2 LPM via nasal cannula, and there were no nutritional risks. A document dated 11/03/22, titled “Visit Note Report” (PTA routine visit), evidenced the patient used O2 at 3 LPM, the patient used O2 at 6.5 LPM, and the patient ambulated with a walker. An additional document dated 11/03/22, titled “Visit Note Report” (RN add-on evaluation), evidenced the patient had difficulty with remembering events, and was alert and oriented to person, place, and time. A document dated 11/08/22, titled “Visit Note Report” (PTA routine visit), evidenced the patient was not wearing her oxygen, and felt more tired today, was wheezing slightly more than last visit, and now had some non-pitting (no “pit” remains in skin when pressed with fingertip) swelling in her ankles; the caregiver obtained a urine sample for urinalysis due to patient’s increased confusion over the past 2 days, and the patient used O2 at 3 LPM via nasal cannula. An additional document dated 11/08/22, titled “Visit Note Report” (LPN routine visit) evidenced the LPN visit occurred 90 minutes after the PTA visit on 11/08/22. The document evidenced the patient was using her O2 at 4 LPM via nasal cannula, had 2+ pitting edema in both lower extremities, the patient was short of breath, and had pronounced expiratory wheezing to both upper portions of the lungs (wheezing indicates partial obstruction of the airway by a foreign substance, such as phlegm or food), and the certifying physician was going to order a chest x-ray and laboratory tests, and was going to contact the caregiver to take the patient for the tests. The document evidenced the LPN notified the Alternate Clinical Manager of the patient’s change in condition. The clinical record failed to evidence a RN performed a visit to update/revise the comprehensive assessment. A document dated 11/09/22, titled “Visit Note Report” (OT add-on evaluation), evidenced the patient’s breathing was labored, pulse rhythm was irregular, presented also with weakness, severe deconditioning, balance deficits, cognitive deficits, shortness of breath at rest with use of O2 at 4 LPM, both lower legs were swollen, and patient was also found to have a UTI. Additionally, the caregiver reported patient was taken to emergency department last night (11/08/22) for a chest x-ray, was now maximum assist for transfers, dependent for all self-care, and had poor alertness; the OT reported to the therapist (no further information) and the certifying physician. The clinical record failed to evidence a RN performed a visit to update/revise the comprehensive assessment. A document dated 11/16/22, titled “H&P [History and Physical] Note” evidenced the patient became unconscious at home, caregivers indicated she was completely unresponsive, “911” was called, and EMS (emergency medical service) staff was able to provide treatment, and the patient regained consciousness, but was confused. Inpatient diagnoses included syncope (fainting), left lower lobe pneumonia, acute on chronic respiratory failure with hypoxia, congestive heart failure, and dementia. During an interview on 2/02/23 at 3:01 PM, the Administrator indicated the patient had a significant change in condition, confirmed no nursing visits were made after the OT visit on 11/09/22, and no RN visit was made after 11/03/22. 4. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s primary diagnosis was urinary tract infection (UTI), other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life), sick sinus syndrome (a type of heart rhythm disorder), acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and dependence on supplemental oxygen (O2) (2 liters per minute [LPM] continuous, via nasal cannula [small tubes inserted into the nostrils to administer oxygen]). A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced no skin issues/problems were identified, and the patient had 2+ pitting edema (swelling that occurs when excess fluid builds up in the body due to heart, circulatory, and/or kidney problems, and when pressed by the tip of a finger, a “pit” remains; 1+ means the “pit” leaves an indentation of 0–2 millimeters [mm] that rebounds immediately; 2+ means the “pit” leaves an indentation of 3–4 mm that rebounds in fewer than 15 seconds; 3+ means the “pit” leaves an indentation of 5–6 mm that takes up to 30 seconds to rebound; and 4+ means the “pit” leaves an indentation of 8 mm or deeper that takes more than 20 seconds to rebound) to both lower extremities. A document dated 11/30/22, titled “Visit Note Report” (Physical Therapy Assistant [PTA] routine visit), indicated the patient sustained a skin tear on the right hip, it was covered with a bandage, and the patient had 3+ bilateral lower extremity edema (worse than previous visit). A document dated 12/07/22, titled “Visit Note Report” (PTA routine visit) evidenced the patient had 3-4+ pitting edema to both lower extremities (worse than last routine visit), and stated, “... [family] reports R [right] buttocks skin tear covered with bandage, reports changed bandage no bleeding noted, patient has bruising at face, UES [upper extremities] that have been long standing ....” A document dated 12/15/22, titled “Visit Note Report” (PT reassessment) evidenced an assessment section, which indicated cardiovascular assessment was “NA” (not applicable), post intervention of pain was “NA”, and the patient did not have a diagnosis or symptoms indicative of respiratory impairment. The clinical record failed to evidence a comprehensive reassessment was completed for the patient’s significant decline in health status. A document dated 12/21/22, titled “Visit Note Report” (PTA routine visit), evidenced new skin tears to the patient’s left forearm and right middle finger, the right hip/buttock wound was healing, family addressed the wounds, the patient had 3+ edema to both feet, and used O2 at 2 LPM. A document dated 12/28/22, titled “Visit Note Report” (PTA routine visit), stated, “... [patient/family] mention having a lot [more] fluid due to having to change dialysis routine and patient is a little boated feeling today. Mentions usually [only] wears supplement oxygen at night but has it on today due to mild shortness of breath without supplemental oxygen ... edema in BLE [bilateral lower extremities] being controlled per [family] ....” The clinical record failed to evidence a comprehensive reassessment was completed for the patient’s significant decline in health status. A document dated 1/05/23, titled “Visit Note Report” (transfer data collected, no visit made) evidenced the patient utilized the emergency department and was admitted to the hospital. A document received from Entity #15 (a hospital) on 1/27/23, titled “Emergency Documentation” evidenced the patient was seen at Entity #15’s emergency department, was diagnosed with a UTI, and was admitted for treatment on 12/30/22. During an interview on 2/01/23 at 2:15 PM, the Administrator indicated the patient was declining and a comprehensive reassessment should have been done. 1. Record review evidenced an agency policy revised 12/1/2013, titled “Significant Change in Condition [Other Follow-Up] Assessment”, which stated, “… A comprehensive assessment is done when the agency is made aware of a significant change in the patient’s condition that was not envisioned in the original plan of care during a 60-day episode … The patient’s condition has either severely deteriorated or greatly improved ….” 2. Clinical record review for Patient #9 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 7/24/2022 – 9/21/2022, which indicated the patient needed continued physical therapy and occupational therapy services for strengthening and fall reduction. Clinical record review evidenced a recertification assessment dated 7/19/2022, which indicated the patient had no wounds, or bruises. Clinical record review evidenced a communication note dated 8/9/2022, which indicated the patient fell 3 times on 8/7/2022, and suffered significant bruising to her face. Clinical record review evidenced a skilled nurse visit note dated 8/9/2022, which indicated the patient fell on her face on 8/7/2022, and had bruising from eyebrows to chin, a bump above the left eyebrow, bilateral black eyes, and a swollen nose. This document indicated the patient did not go to the emergency room. Clinical record review evidenced a coordination note dated 8/16/2022, which indicated the patient fell on Sunday 8/14/2022, had a bloody nose, and did not go to the emergency room. Clinical record review evidenced a coordination note entered on 9/7/2022, which indicated the patient fell on 9/5/2022, and died the next day 9/6/2022. Clinical record review failed to evidence the comprehensive assessment was updated after any of the falls, or due to the patient’s decreasing mobility, extensive bruising, black eyes, bloody noses, or swollen nose. During an interview on 1/26/2023, at 3:09 PM, administrator/clinical manager #1 indicated the agency should have completed an updated comprehensive assessment when there was change in patient condition. Administrator/clinical manager #1 indicated they were not sure the patient had a change in condition. Administrator/clinical manager #1 indicated the patient was pretty much the same.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure a comprehensive assessment occurred within 48 hours, for 1 of 1 clinical record reviewed with a patient who returned home from a hospital admission of 24 hours or more during the certification period (#16). Findings include: An agency policy with revised date 3/01/22, titled "Patient Assessment, Initial and Reassessment", stated, "... A qualified clinician performs a comprehensive ... reassessment visit in the following situations ... within 48 hours following post-hospitalization ...." Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document dated 1/05/23, titled “Visit Note Report” evidenced the patient utilized the emergency department and was admitted to the hospital, but failed to evidence why the patient was hospitalized. A document received from Entity #15 on 1/27/23, titled “Emergency Documentation” evidenced the patient was seen at Entity #15’s emergency department, was diagnosed with a UTI, and was admitted for treatment on 12/30/22. A document received from Entity #15 on 1/27/23, titled “History and Physical Reports”, evidenced the patient was discharged from Entity #15 on 1/02/23. An untitled document dated 1/05/23, evidenced the document was a physician’s order, which indicated a resumption of care visit was ordered for the week of 1/01/23. During an interview on 2/02/23 at 1:55 PM, the Administrator indicated the family didn’t notify the agency the patient was in the hospital until 1/04/23, the agency obtained hospital records on 1/05/23, and she didn’t know why the resumption of care didn’t occur until 1/09/23.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to: ensure patients received the home health services which were written in an individualized plan of care (see tag G572); ensure the plan of care included: all pertinent diagnoses, the patients’ mental/psychosocial, and cognitive status, the types of services, supplies and equipment required, the frequency and duration of visits to be made, nutritional requirements, all medications and treatments, safety measures, a description of the patient’s risk for emergency department visits and hospital re-admission, and interventions to address the underlying risk factors, patient and caregiver education and training, patient-specific interventions and education, measurable outcomes and goals, information related to advanced directives, and/or any additional items (see tag G574); ensure services were provided, only as ordered by the physician (see tag G580); review and revise the plan of care (see tag G586); ensure the physician was promptly notified of any changes in patients’ condition which suggested goals were not being achieved (see tag G590); coordinate care delivery (see tag G0608); provide patients with written visit schedules (see tag G614); ensure patients received written medication schedule/instructions including medication name, dose and frequency of medications to be taken (see tag G616); and provide patients with written instructions outlining treatments to be administered by home health personnel or personnel acting on behalf of the home health agency (see tag G618). This practice had the potential to affect all patients serviced by the agency. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care. A standard level deficiency was also cited at this level as follows: Based on observation, record review, and interview, the home health agency failed to ensure it only accepted patients for services if the needs of the patient could be met for 9 of 17 records reviewed. (#2, 3, 5, 6, 9, 12, 14, 16, 17). The findings include: *. Observation of a home visit for Patient #2 was conducted on 1/25/2023, at 10:00 AM, to observe a routine skilled nurse visit. During the visit, the patient was observed to be alert and oriented, sitting in a wheelchair. The patient lived alone, and had a home health aide from home health agency #15, who was present at the time of the home visit. The patient had bilateral lower leg weakness and was only able to stand up out of the wheelchair for a moment so the nurse could assess his bottom. Clinical record review for Patient #2 was completed on 2/2/2023, for certification period 11/30/2022 – 1/28/2023. Record review evidenced a referral order dated 11/30/2022, which indicated the patient required nursing, physical therapy, occupational therapy, nutritional services, social work services, and a home health aide. Clinical record review evidenced a start of care assessment dated 11/30/2022, which indicated the patient required substantial/maximal assistance with bathing, grooming, transferring, and activities of daily living. The assessment indicated the mobility goals were for patient to be able to complete activities of daily living, bathing, transferring, and grooming independently, with only minor assistance before and after the activity. This document indicated based on the assessment, the nurse was recommending physical therapy, occupational therapy, and social work services. Clinical record review evidenced a plan of care for certification period 11/30/2022 – 1/28/2023, which indicated the patient was to receive only skilled nursing services. Clinical record review failed to evidence the patient was offered or provided physical therapy, occupational therapy, nutritional, social work, or home health aide services. Clinical record review evidenced a skilled nurse visit note dated 1/6/2023, which indicated the patient was found laying in stool, with a catheter bag full of urine and laying on the ground next to the bed. This visit note indicated the patient was bedbound except for 3 hours per day, when a caregiver was present. During an interview on 1/25/2023, at 10:30 AM, Patient #2 indicated he could not get out of bed unless someone was home with him, due to fear of falling, and weakness. Patient #2 indicated he had previously been able to ambulate to appointments using a cane but was more dependent upon a wheelchair now. Patient #2 indicated they had a history of falling and had previously received therapy services. Patient #2 indicated he almost fell getting into the shower recently. During an interview on 1/23/2023, at 9:53 AM, administrator/clinical manager #1 indicated if the home health agency could not meet the patient’s needs, they would notify the referral source they were unable to accept the patient for care. During an interview on 1/31/2023, at 10:21 AM, administrator/clinical manager #1 indicated they did not know why the patient did not receive therapy services as ordered. *. Observation of a home visit for Patient #3 was conducted on 1/26/2023, at 10:00 AM, to observe a routine occupational therapy visit. During the visit, the patient was observed to be alert and oriented. The patient ambulated with a walker, and indicated they required assistance while bathing. Patient #3 indicated at 10:15 AM, that they showered with the assistance of a family member. Clinical record review for Patient #3 was completed on 2/2/2023, for certification period 12/8/2022 – 2/5/2022. Record review evidenced a referral order dated 12/7/2022, which indicated the patient required skilled nursing, physical therapy, occupational therapy, and a home health aide for bathing. Clinical record review evidenced a plan of care for certification period 12/8/2022 – 2/5/2023, which indicated the patient was receiving skilled nursing, physical therapy, and occupational therapy. Record review failed to evidence the patient received a bath aide as ordered on referral. Clinical record review evidenced a referral order dated 1/5/2023, which indicated the patient was discharging from the hospital 1/7/2023, and required skilled nursing, physical therapy, occupational therapy, and a bath aide. Record review failed to evidence the patient received a bath aide as ordered. During an interview on 1/31/2023, at 12:13 PM, administrator/clinical manager #1 indicated maybe the patient was at her baseline, and that was why they didn’t receive home health aide services. At 12:18 PM, administrator/clinical manager #1 indicated the patient should have received a bath aide. *. Observation of a home visit for Patient #5 was completed on 1/27/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient was observed to be sitting in a wheelchair. The patient was alert and oriented, and was able to stand, pivot and transfer to the bed for wound care to a wound on his bottom. Clinical record review for Patient #5 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/21/2022 – 2/18/2023, which indicated the patient was to receive skilled nursing visits only. Record review failed to evidence the patient had been offered physical or occupational therapy visits. Clinical record review evidenced a recertification assessment dated 12/16/2022, which indicated patient was unable to transfer self, and required assistance for bathing, dressing, and activities of daily living. This document indicated the patient required the use of a wheelchair to exit the residence and had weakness in lower extremities causing balance or gait disturbances and/or falls. During an interview on 1/27/2023, at 8:45 AM, Patient #5 indicated he would benefit from therapy services since he was wheelchair-bound currently. During an interview on 1/31/2023, at 12:35 PM, administrator/clinical manager #1 indicated they would offer Patient #5 therapy services. Administrator/clinical manager #1 did not know why he was not offered therapy services prior. *. Clinical record review for Patient #6 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a referral order dated 1/6/2023, which indicated the patient was to receive skilled nursing, physical therapy, and occupational therapy. Clinical record review evidenced a plan of care for certification period 1/1/2023 – 3/10/2023, which indicated the patient failed to be provided skilled nursing services. During an interview on 1/31/2023, at 12:58 PM, administrator/clinical manager #1 indicated they did not know why the patient didn’t receive skilled nursing as ordered. 6. Clinical record review for Patient #9 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 7/24/2022 – 9/21/2022, which indicated the patient needed continued physical therapy and occupational therapy services for strengthening and fall reduction. Clinical record review evidenced a physician order dated 8/9/2022, which indicated physical therapy was to evaluate and treat the patient, for 1 visit effective 8/7/2022. Clinical record review evidenced a physician order entered on Friday, 8/12/2022, which indicated the patient’s spouse had requested the physical therapy visit be moved to the next week 8/14/2022. Clinical record review evidenced a coordination note dated 8/16/2022, which indicated the patient fell on Sunday 8/14/2022, had a bloody nose, and did not go to the emergency room. Clinical record review evidenced a physician order entered on Thursday, 8/18/2022, which indicated the physical therapy visit had been deleted for the week of 8/14/2022, and was to be added back, effective 8/14/2022. Clinical record review evidenced a physician order entered on Friday, 8/19/2022, which indicated the physical therapy visit was to be moved to the next week, 8/21/2022, per patient’s spouse. Clinical record review indicated the patient did not receive physical therapy for 34 days after the start of the certification period, or from 7/24/2022, until 8/26/2022. Record review failed to evidence the patient had been provided occupational therapy services. Clinical record review evidenced a communication note dated 8/9/2022, which indicated the patient fell 3 times on 8/7/2022, and suffered significant bruising to her face. Clinical record review evidenced a skilled nurse visit note dated 8/9/2022, which indicated the patient fell on her face on 8/7/2022, and had bruising from eyebrows to chin, a bump above the left eyebrow, bilateral black eyes, and a swollen nose. This document indicated the patient did not go to the emergency room. Clinical record review evidenced a coordination note entered on 9/7/2022, which indicated the patient fell on 9/5/2022, and died the next day 9/6/2022. Clinical record review failed to evidence the plan of care was updated, frequency of visits was increased, or additional measures were implemented to prevent falls. Record review failed to evidence results of physician communication regarding patient’s status and falls. During an interview on 1/26/2022, at 2:52 PM, administrator/clinical manager #1 indicated they did not know why physical therapy was not provided until after the fall. Administrator/clinical manager #1 indicated they did not know why occupational therapy services were not provided. Administrator/clinical manager #1 indicated the patient’s husband would refuse visits, and the patient would defer communication to her husband a lot of the time. Administrator/clinical manager #1 indicated the physician was notified of the falls but did not know what the results of the communication were, since they were not documented. Administrator/clinical manager #1 indicated the plan of care should have been updated if there was any change in patient status, and results of communication with physicians documented. 410 IAC 17-13-1(a) *An agency policy with revised date 1/01/23, titled “Admission Process”, stated, “... Patients admitted to home care services ... have reasonable expectations that needs can be safely met ... The agency ... Must be able to meet the patient’s needs ... Admits patients ... according to physician’s orders ....” * An agency policy with revised date 12/01/11, titled “Personal Care”, stated, “... To promote cleanliness and comfort, it is the policy of the agency to provide/assist patients, as needed, to obtain personal care while maintaining patient safety ....” * A home visit was observed on 1/27/23 at 2:00 PM with Patient #12, PTA #2, and the Alternate Clinical Manager. The patient indicated her handicap accessible van broke down, so she was unable to get her blood drawn yesterday (1/26/23) for her weekly PT/INR (to monitor therapeutic level of blood thinner medication), she went every Thursday for the blood draw, and she was very worried about it because her warfarin dose changed a lot. The patient also indicated she was dehydrated, and her irritable bowel syndrome (IBS) (an intestinal disorder causing pain in the belly, gas, diarrhea, and constipation) was flaring up. PTA #2 and the Alternate Clinical Manager offered to help find numbers to call for transportation needs, but failed to offer skilled nursing to obtain the blood sample, and failed to instruct on mitigation of dehydration or IBS. The agency failed to meet the patient’s immediate needs. Clinical record review for patient #12 was completed on 2/01/23 (start of care date 1/18/23, certification period 1/18/23 – 3/18/23). A document titled “Home Health Certification and Plan of Care” (for certification period 1/18/23 – 3/23/23), evidenced PT was the only ordered service. During an interview on 2/01/23 at 11:18 AM, the Administrator indicated an unscheduled nursing visit would need to be classified as an emergency, asked if a blood draw was considered an emergency, and indicated the PT/INR should have been addressed on Friday (1/27/23) during the home visit, as well as the patient’s dehydration and IBS flare up. * Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document titled “[Entity #25, a skilled nursing facility] evidenced the agency received a referral for homecare services on 10/17/22. An untitled document, dated and signed by Person #26 (a nurse practitioner) on 10/14/22, evidenced the document was an order, which stated, “... May [discharge] to home with [home health] PT [physical therapy] ... OT [occupational therapy] ... Nursing Services ....” A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/27/22 – 12/25/22), evidenced skilled nursing was ordered for 1 visit during the week of 10/30/22, PT was ordered once weekly for 7 weeks, then every other week for 2 weeks, and OT was ordered for 1 visit during the week of 11/06/22. The initial evaluation/comprehensive assessment was completed by PT, and occurred 10 days after the agency received the referral for home care services. The Registered Nurse (RN) evaluation occurred on 11/03/22 (week 2), 17 days after the referral was received; and the OT evaluation occurred on 11/09/22 (week 3), 23 days after the referral was received. The agency failed to meet the patient's immediate needs. During an interview on 2/02/23 at 3:01 PM, the Administrator indicated she didn’t know why services were delayed. * Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document with printed date 11/14/22, titled “History and Physical Report”, indicated the patient had new peritoneal catheter (a tube that is inserted into the lining of the abdomen to filter blood within the body during dialysis) placement on 10/18/22, to begin home peritoneal dialysis. A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced PT was ordered weekly for 8 weeks, and no additional disciplines were ordered. The patient’s primary diagnosis was urinary tract infection (UTI), other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life), sick sinus syndrome (a type of heart rhythm disorder), acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and dependence on supplemental oxygen (O2) (2 liters per minute [LPM] continuous, via nasal cannula [small tubes inserted into the nostrils to administer oxygen]). A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the patient had multiple risks for emergency department use/hospital readmissions, a risk for development of pressure ulcers, was dependent for all personal care, could not walk, and the PT recommended palliative care (a specialized form of care that provides symptom relief, comfort and support to individuals living with serious illnesses, and also provides support to caregivers and those impacted by a loved one’s condition), to which the patient and family agreed, and the PT planned to talk with the patient’s primary care physician for a referral to initiate palliative care. The clinical record failed to evidence palliative care was initiated, nursing services was ordered for the patient’s complex medical conditions, home health aide services was ordered for assistance with personal care, medical social services was ordered to assist with patient/family psychosocial needs, or occupational therapy was ordered to assess for safety in activities of daily living/personal care. During an interview on 1/26/23 at 2:02 PM, family indicated the patient officially started hospice services today (1/26/23). During an interview on 2/01/23 at 2:15 PM, the Administrator stated, “... We do not provide palliative care with this agency ....”, indicated she didn’t know why other disciplines weren’t ordered, didn’t know why palliative care wasn’t followed up on, and she would check into it. During an interview on 2/02/23 at 1:55 PM, the Administrator indicated family was unrealistic with palliative care, repeatedly refused palliative care, family repeatedly did not want a nurse, family thought peritoneal dialysis was going to be the answer to make the patient well, agency staff felt the patient was experiencing end of life for some time now, the patient had frequent skin tears/issues due to immobility, remained in the same position too long, and her skin was very thin/fragile. The agency failed to meet the patient and family needs to address coping skills with potential end of life, or skin and mobility issues. * Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document dated and signed by Person #7 (the patient’s certifying physician) on 7/05/22, titled “Referral Order”, stated, “... Home Health Referral ... need SN [skilled nurse], PT [physical therapy], and OT [occupational therapy] ....” A document dated 7/08/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the patient was dependent for personal care (tasks such as bathing, grooming, toileting). A document titled “Home Health Certification and Plan of Care”, for initial certification period 7/08/22 – 9/05/22, evidenced one SN visit was ordered effective during the week of 7/17/22 (week 3), and PT was ordered weekly for 9 weeks. The document failed to evidence why OT services were not provided, why SN services were delayed, or how the agency ensured the patient’s personal care needs were met. A document dated 7/14/22, titled “Complaint Report”, stated, “... [family] called [agency] on 7/13/22 to determine if [physician] orders for nursing had been obtained and to request skilled nurse visit to assess patient swelling in lower extremity and report of increased incontinence. Patient [family] that nursing evaluation currently scheduled for early next week [week of 7/17/22], and that if [appointment] became available nurse visit would be scheduled ... [family] stated she was not happy with delay for nurse visit ... [family] relayed that [physician] told her patient would be getting nursing and therapy services ... Explained that PT [physical therapy] visit on Friday scheduled and that Therapist would be able to complete assessment and report findings to [physician] as well ... [Family] stated I guess there is nothing I can do, but I am still not happy ... Educated [family] on role of nurse in home regarding skilled services rather than on-call availability to check in on her [patient] ....” A document dated 7/16/22, titled “Visit Note Report” (RN Add-On Evaluation), evidenced the patient had generalized (affecting many parts of the body) bruising, dizziness, vertigo (poor balance), headache, and required frequent laboratory blood testing to monitor the patient’s blood coagulation and disease progression. A document dated 8/18/22, titled “Visit Note Report” (RN discipline only discharge visit), evidenced the nurse obtained a blood specimen for laboratory testing (complete blood count [CBC], comprehensive metabolic panel [CMP], and lipid panel), and discharged nursing services (prior to receipt of lab results). An additional document dated 8/18/22, titled “Visit Note Report” (PT routine visit), evidenced the patient had an appointment with Person #10 (a neurosurgeon), and the patient was going to have surgery for drain placement for hydrocephalus (buildup of fluid around the brain, which causes problems with walking, progressive mental impairment, and poor coordination and balance). The EMR failed to evidence any subsequent visits were made by agency staff prior to emergency department evaluation on 8/24/22 and hospital admission on 8/26/22. A document received from Entity #15 (a hospital) on 1/27/23, dated 8/25/22, titled “Emergency Documentation”, evidenced the patient was seen in the emergency department (ED) on 8/24/22 at 9:30 AM, medics indicated the patient was using the toilet, stood up, then passed out, and laid on the floor for 2 hours; on 8/25/22, the patient was released from the hospital, and subsequently returned to the hospital the same day (8/25/22) and was seen at 8:34 PM. Family indicated that since she came home from the hospital at 4:00 PM, she has had increased weakness and confusion, the patient was on blood thinners and had a fall 3 days ago. The patient was admitted on 8/26/22 at 8:31 AM. A document received from Entity #15 on 1/27/23, dated 9/14/22, titled “Discharge Summary”, evidenced the patient’s inpatient diagnoses included normal pressure hydrocephalus, intraventricular bleed (brain bleed), leukocytosis (high white cell blood count), and UTI. During an interview on 2/02/23 at 3:45 PM, the Administrator indicated she didn’t know why nursing services were delayed, confirmed the clinical record failed to evidence how the agency ensured the patient’s personal care needs were safely met, nursing services shouldn’t have been discontinued on 8/18/22 with outstanding lab results and the pending surgical drain placement. * During an interview on 1/23/23 at 9:35 AM, the Administrator indicated the agency did not currently provide Home Health Aide (HHA) services, a nurse or therapist would provide HHA services if indicated, it would be incorporated into the plan of care, and indicated an on-call nurse would provide a nursing visit if needed.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patient received all services included in the plan of care, the plan of care was individualized, and/or the patient received all services ordered by the referring physician for 15 of 17 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 17). Findings include: *. Clinical record review for Patient #1 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 1/10/2023 – 3/10/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” During an interview on 1/31/2023, at 9:56 AM, administrator/clinical manager #1 indicated the plan of care was individualized based on the patients’ assessment. Administrator/clinical manager #1 indicated the plan of care should include individualized interventions and parameters based on the assessment of problems. Administrator/clinical manager #1 indicated the telephonic teaching visit shouldn’t have been included in everyone’s plans of care. *. Clinical record review for Patient #2 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 11/30/2022 – 1/28/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” *. Clinical record review for Patient #3 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/8/2022 – 2/5/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” *. Clinical record review for Patient #4 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/8/2022 – 2/5/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” *. Observation of a home visit for Patient #5 at 1/27/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient was observed to have a colostomy (opening through the skin of the stomach, which connects to the large intestine, and allows stool to exit the body). Clinical record review for Patient #5 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/21/2022 – 2/18/2023, which failed to be individualized to include any treatment, orders, or diagnoses regarding patient’s colostomy status. The plan of care stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” During an interview on 1/31/2023, at 12:32 PM, administrator/clinical manager #1 indicated the plan of care should have included information regarding the patient’s colostomy. *. Clinical record review for Patient #6 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 1/10/2023 – 3/10/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” *. Clinical record review for Patient #7 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/2/2022 – 1/30/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” *. Clinical record review for Patient #8 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 1/5/2023 – 3/5/2023, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” The plan of care indicated the patient had a wound, and also included a goal of remaining free from skin breakdown. The goals on the plan of care failed to be individualized. During an interview on 1/30/2023, at 2:43 PM, administrator/clinical manager #1 indicated the goal of remaining free from skin breakdown was not individualized. *. Clinical record review for Patient #9 was completed on 2/2/2023, for certification period 7/24/2022 – 9/21/2022. Record review evidenced a recertification assessment dated 7/19/2022, which indicated the patient was at risk for falls. Clinical record review evidenced a plan of care for certification period 7/24/2022 – 9/21/2022, which stated, “… May use telehealth and telecommunications to provide services as necessary and appropriate according to the patient’s condition and in accordance with the plan of care ….” The plan of care failed to be individualized to include any specific fall prevention techniques or measures to be taken to prevent falls. During an interview on 2/1/2023, at 10:00 AM, administrator/clinical manager #1 indicated the plan of care should have had more specifics for fall prevention. 410 IAC 17-13-1(a) *An agency policy with revised date 1/01/23, titled “Admission Process”, stated, “... Patients admitted to home care services ... have reasonable expectations that needs can be safely met ... The agency ... Must be able to meet the patient’s needs ... Admits patients ... according to physician’s orders ....” * An agency policy with revised date 12/01/11, titled “Personal Care”, stated, “... To promote cleanliness and comfort, it is the policy of the agency to provide/assist patients, as needed, to obtain personal care while maintaining patient safety ....” *Clinical record review for patient #12 was completed on 2/01/23 (start of care date 1/18/23, certification period 1/18/23 – 3/18/23). A document titled “Home Health Certification and Plan of Care” (for certification period 1/18/23 – 3/23/23), evidenced the patient’s primary diagnosis was Ehlers Danlos Syndrome (a group of disorders that affect connective tissues supporting the skin, bones, blood vessels, and many other organs and tissues), and secondary diagnosis was atrial fibrillation (an irregular heartbeat which requires regular use of blood thinners), and the patient went to an outpatient coumadin clinic (a clinic that manages therapeutic blood levels for use of anticoagulants). The plan of care failed to be individualized to include what coumadin clinic the patient went to, which day of the week, or the name and contact information for the clinic and the physician responsible for the care at the clinic; and failed to include interventions/goals specific to the patient’s diagnoses of Ehlers Danlos Syndrome or atrial fibrillation. During an interview on 2/01/23 at 11:18 AM, the Administrator indicated information for other physicians who provided treatment to the patient didn’t need to be on the plan of care, she thought the interventions/goals for Ehlers Danlos Syndrome were okay because they dealt with mobility, and she didn’t know which coumadin clinic the patient went to, or who the physician was. * Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 12/03/22 – 1/31/23). A document dated 11/28/22, titled “Visit Note Report” (PT recertification, comprehensive reassessment), evidenced the patient’s diabetes and hypertensive chronic kidney disease (stage 3) symptoms were poorly controlled, and needed frequent adjustments in treatments and dose monitoring; the patient was short of breath with moderate exertion, and had urinary incontinence; hasn’t had a HgbA1c (a blood test which estimates the average daily blood sugar levels over the past couple of months) test in the past 3 months, and contact physician to obtain an order; indicated patient checked blood sugars as ordered (no further information), results were within patient specific parameters (no further information), patient didn’t perform foot exams, didn’t have a podiatrist, needed help with dressing and grooming, and stated, “... Patient continues to require assistance with all transfers and bed mobility ... remains unsteady ambulating with walker ... remains a high fall risk ... shortness of breath with moderate exertion today ... pain levels are slowly improving following her fall a couple of weeks ago ... Patient reports ... she continues to require assistance with most daily activities due to generalized weakness ....” A document titled “Home Health Certification and Plan of Care” (for certification period 12/03/22 – 1/31/23), evidenced the patient lived alone, and failed to evidence it was individualized to include how the agency mitigated the patient’s poorly controlled diabetes and hypertensive chronic kidney disease symptoms, or the patient’s shortness of breath and urinary incontinence; failed to evidence a HgbA1c was ordered, how often the patient checked her blood sugars, order for a podiatrist evaluation, how the agency ensured the patient’s safety due to living alone, or received assistance with her daily activities and personal care. During an interview on 2/02/23 at 2:33 PM, the Administrator indicated the plan of care wasn’t individualized. * Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/27/22 – 12/25/22), evidenced skilled nursing was ordered for 1 visit during the week of 10/30/22, PT was ordered once weekly for 7 weeks, then every other week for 2 weeks, and OT was ordered for 1 visit during the week of 11/06/22. The plan of care failed to evidence any skilled nursing or OT interventions or goals. During an interview on 2/02/23 at 3:01 PM, the Administrator indicated there were other orders in the medical record with nursing and OT interventions and goals, but did not indicate they were updates to the patient’s plan of care. * Clinical record review for patient #15 was completed on 2/02/23. A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s medications included levetiracetam (an anti-seizure medication); and stated, “... Patient ... medical history is significant for frequent falls and hypertension [high blood pressure] ... patient attributes frequent falls to syncopal [fainting] episodes ....” The plan of care failed to be individualized to include interventions or goals for syncope or seizures. A web base referenced on 2/01/23 from the National Library of Medicine (https://www.ncbi.nlm.nih.gov/books/NBK442006/), updated 6/21/22, titled “Syncope”, indicated seizures could mimic syncopal episodes. During an interview on 2/02/23 at 3:30 PM, the Administrator indicated there weren’t interventions or goals on the plan of care for syncope or seizures. * Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s primary diagnosis was Urinary Tract Infection (UTI); other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life). The plan of care failed to be individualized to include interventions/goals for diagnoses of UTI, or hypertensive heart and chronic kidney disease with heart failure and stage 5 chronic kidney disease. During an interview on 2/01/23 at 2:15 PM, the Administrator indicated she didn’t know why the patient’s primary diagnosis was coded as UTI, and indicated there should be interventions and goals for pertinent diagnoses. * Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document titled “Home Health Certification and Plan of Care” (for certification period 7/08/22 – 9/05/22), evidenced skilled nursing was ordered for one visit during the week of 7/17/22, and physical therapy (PT) was ordered weekly for 9 weeks. The document also evidenced the patient’s primary diagnosis was (idiopathic) normal pressure hydrocephalus (a condition that happens when cerebrospinal fluid builds up inside your skull and presses on your brain, which causes gait issues, urinary incontinence, and cognitive difficulties), and other diagnoses included essential (primary) hypertension (high blood pressure). The plan of care failed to be individualized to include patient-specific interventions/goals for diagnoses of normal pressure hydrocephalus or hypertension; or any skilled nursing interventions/goals. During an interview on 2/02/23 at 3:45 PM, the Administrator indicated the nursing interventions/goals were on a subsequent order, but it was not titled as an updated plan of care, and the interventions/goals weren’t specific to the patient’s diagnoses. 17 IAC 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the plan of care included: all pertinent diagnoses, the patients’ mental/psychosocial, and cognitive status, the types of services, supplies and equipment required, the frequency and duration of visits to be made, nutritional requirements, all medications and treatments, safety measures, a description of the patient’s risk for emergency department visits and hospital re-admission, and interventions to address the underlying risk factors, patient and caregiver education and training, patient-specific interventions and education, measurable outcomes and goals, information related to advanced directives, and/or any additional items in 14 of 17 clinical records reviewed. (#1, 2, 3, 4, 5, 7, 8, 9, 12, 13, 14, 15, 16, 17). The findings include: 10. A home visit was observed on 1/27/23 at 2:00 PM with Patient #12, PTA #2, and the Alternate Clinical Manager. The patient indicated her handicap accessible van broke down, so she was unable to get her medical appointment yesterday (1/26/23). PTA #2 instructed on the continued use of heat and ice for pain relief. Clinical record review for patient #12 was completed on 2/01/23 (start of care date 1/18/23, certification period 1/18/23 – 3/18/23). A document dated 1/18/23, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the patient needed help with grooming and dressing, difficulty completing most daily activities, multiple emergency room visits over the past several months, significant difficulty with sleep, pain impacted mobility, and the patient preferred afternoon visits. A document dated and signed by Person #1 (the patient’s certifying physician) on 1/13/23, evidenced the document was a physician’s progress note, other physicians involved with the patient’s care included Person #2 (Hematology/Oncology), Person #3 (Clinical Cardiac Electrophysiologist), Person #4 (Cardiologist), Person #5 (patient’s primary care nurse practitioner), and Person #6 (Gastroenterologist); thirty-two allergies included albuterol (an inhaled respiratory medication), Asmanex twisthaler (used to treat symptoms of asthma), aspartame (artificial sweetener), axid (an anti-acid), bentyl (used to treat spasms of the intestines), carafate (used to treat stomach ulcers and gastroesophageal reflux disease [acid reflux]), cleocin (an antibiotic), cloace (stool softener), demerol (a narcotic pain medication), Eliquis (a blood thinner), flagyl (an antibiotic), heparin (a blood thinner), iodinated contrast media (medication injected into a vein to enhance the ability to see blood vessels and organs on medical images), lidocaine (numbing agent), hydrocodone (a narcotic pain medication), minocin (an antibiotic), monosodium glutamate (MSG) (a flavor enhancer used in food recipes), morphine (a narcotic pain medicine), naproxen (nonsteroidal anti-inflammatory drug [NSAID] used to treat pain), neomycin (an antibiotic), nitrous oxide (a sedative agent, “laughing gas”), oxycodone (a narcotic pain medication), Pradaxa (an anticoagulant used to treat and prevent blood clots and to prevent stroke in people with atrial fibrillation), prednisone (a steroid anti-inflammatory), propylene glycol (a laxative), protonix (used to decrease stomach acid production), statin drugs (used to lower cholesterol), sulfa drugs (sulfonamide antibiotics), ultram (a narcotic pain medication), valtrex (antiviral medication), vancomycin (an antibiotic), and Zithromax (an antibiotic); diagnoses included breast cancer, skin cancer, obesity, vitamin D deficiency (symptoms could include fatigue, back pain, hair loss, poor wound healing, and symptoms of depression), paroxysmal ventricular tachycardia (intermittent rapid heart beat which can cause dizziness, lightheadedness, and fainting), chronic orthostatic hypotension (a form of low blood pressure that happens when standing after sitting or lying, causing lightheadedness, dizziness, or fainting), postural orthostatic tachycardia syndrome (POTS) (Symptoms related to the reduced blood volume that occurs when a person stands up after lying down, and causes lightheadedness, fainting, and rapid heartbeat, which are relieved by lying down again), celiac disease (autoimmune disease where the ingestion of gluten leads to damage in the intestines), lumbosacral spondylosis without myelopathy (degeneration of the lower spine without damage to the spinal cord, and includes ongoing pain caused by compressed nerves), lumbosacral radiculitis (inflammation of a nerve root in the lower back, which causes symptoms of pain or irritation in the back and down the legs), and history of thromboembolism (blood clot); the patient had a left breast mastectomy on 3/30/15, and pacemaker placement occurred on 11/29/17; and ordered diet was gluten free, low sodium, and no MSG. A document titled “Home Health Certification and Plan of Care” (for certification period 1/18/23 – 3/23/23) evidenced the patient had a regular diet (no restrictions), and had no allergies. The plan of care failed to include the significant diagnoses listed in the certifying physician’s progress note which could affect he patient’s safety, increased fall risk, and outcomes of treatment provided by the agency; failed to include the patient’s 32 allergies, or ordered diet; modalities for pain relief included heat/ice (or indications/precautions for use); how the agency ensured daily activities were completed safely, how the agency mitigated multiple emergency room visits over the past several months, or significant difficulty with sleep; or psychosocial information included the patient preferred afternoon visits, and required a handicap accessible van for transportation. During an interview on 2/01/23 at 11:18 AM, the Administrator indicated heat/ice, compression stockings, and allergies should be on the plan of care; she wouldn’t include the patient’s (psychosocial needs) transportation needs and preference for afternoon visits on the plan of care; she didn’t know what PT could do about the sleep disorder, and it was sort of not a PT task; the patient only wanted certain services with certain people, that’s all she’d allow, and didn’t know if the clinical record included that information; they don’t offer home health aide services, but did have OT for patients that have difficulty with personal care needs, sometimes patients accept the service, and sometimes they don’t, but it should be documented. 11. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 12/03/22 – 1/31/23). A document titled “Home Health Certification and Plan of Care” (for certification period 12/03/22 – 1/31/23), evidenced a medication order for daily application of antibiotic ointment to a heel wound. The plan of care failed to evidence a wound diagnosis, wound care orders (cleansing solution, cover dressing, who performed the care), or the location of the wound. A document dated 12/13/22, titled “Visit Note Report” (PT reassessment visit) evidenced the patient used heat and cold applications, and over the counter medications for pain relief. The plan of care failed to evidence modalities of heat and cold application, or instructions/precautions for use; or any over the counter medications for pain relief. During an interview on 2/02/23 at 2:33 PM, the Administrator indicated the plan of care didn’t include the heat or cold applications, or over the counter pain medications. 12. Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document dated 10/17/22, titled “... Order Category: Dietary, Pharmacy ... Active Orders As Of ... 10/17/22”, evidenced the document originated from Entity #25 (a skilled nursing facility). The document listed the patient’s current diagnoses, which included obstructive and reflux uropathy (a disorder of the urinary tract that occurs due to obstructed urinary flow), UTI, dysphagia, oropharyngeal phase (difficulty initiating a swallow, and swallowing may be accompanied by regurgitation, aspiration [the drawing in of a foreign substance into the lungs], and a sensation of residual food remaining in the throat), need for assistance with personal care, other symptoms and signs concerning food and fluid intake, and stage 2 pressure ulcer, other site (characterized by partial-thickness skin loss into but no deeper than the layers of the skin, which includes intact or ruptured blisters). A document dated 10/14/22, titled “[Entity #25] ... Progress Notes”, evidenced the patient’s family had an appointment with Entity #27 (an oxygen and medical equipment company) for training on BiPap (a device that helps with breathing, and forces intermittent air into the lungs), and the patient’s advance directive was DNR (Do Not Resuscitate). A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/27/22 – 12/25/22), evidenced the patient’s primary diagnosis was acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and additional diagnoses included pneumonitis due to inhalation of food and vomit (an infection of the lungs caused by inhaling saliva, food, liquid, vomit and even small foreign objects into the lungs), sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues), and type 2 diabetes (adult onset); had 10 hours paid caregiver support daily; the patient had no advance directives; and was on a regular diet (no dietary restrictions). The plan of care failed to include the patient’s diagnoses of obstructive and reflux uropathy, UTI, need for assistance with personal care, other symptoms and signs concerning food and fluid intake, and stage 2 pressure ulcer, other site; equipment included a BiPap machine and associated mask, tubing, etc.; the patient’s advance directive was DNR; safety measures included aspiration precautions and risk for skin breakdown; any dietary restrictions due to risk of aspiration; what services the paid caregivers provided; or patient-specific interventions and goals for the patient’s diagnoses of pneumonitis due to inhalation of food and vomit, Sepsis, type 2 diabetes, obstructive and reflux uropathy, UTI, need for assistance with personal care, other symptoms and signs concerning food and fluid intake, and stage 2 pressure ulcer, other site; and failed to include the location or treatment of the pressure ulcer. On 2/02/23 at 3:01 PM, during the clinical record review, the Administrator indicated the patient had multiple complex comorbidities that weren’t addressed on the plan of care. 13. Clinical record review for patient #15 was completed on 2/02/23. A document dated 12/28/22, titled “History and Physical Reports” (Entity #15, a hospital), evidenced the patient was prescribed a heart healthy diet (low fat, cholesterol, and salt), and experienced recurrent syncope (fainting spells). A document dated 1/09/23, titled “Outpatient Surgical Report/Discharge Summary”, evidenced Person #23 (an orthopedic surgeon) performed surgery on the patient to repair the right elbow on 1/09/23, and staples were used to close the skin. A document dated 11/13/22, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced the patient had a follow up appointment with Person #23 on 1/20/23, patient knowledge-based deficits included special diet/fluid restrictions, safety hazards included unsafe floor coverings, sanitation issues included cluttered/soiled living area, the patient had pain to the right elbow, and pain relief measures included immobility. A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced PT was the only ordered service, the patient’s certifying physician was person # 24, the patient’s primary diagnosis was laceration without foreign body of other part of head, subsequent encounter (unspecified open wound of unspecified part of head), and other diagnoses included fracture of right elbow, generalized anxiety disorder, hypertension (high blood pressure), and UTI; medications included levetiracetam (an anti-seizure medication); risks for emergent care and hospitalization included multiple recent hospitalizations/emergency department visits in the past 6 months, decline in mental, emotional, or behavioral status in the past 3 months, currently taking 5 or more medications, and “other risks” (not further specified); safety measures included fall risk; nutritional requirements was regular (unrestricted diet); interventions included to change dressing as needed in order to maintain a clean dry dressing and cover with a nonadherent island dressing, and management of depression; goals included reduction in signs and symptoms of depression; and stated, “... Patient presents with a long arm splint [used to immobilize the elbow joint] ... Patient ... medical history is significant for frequent falls and hypertension [high blood pressure] ... patient attributes frequent falls to syncopal [fainting] episodes ....” The plan of care failed to evidence a diagnosis of depression, the patient’s nutritional requirement of a heart healthy diet, any treatment for the primary diagnosis of head laceration, or incision treatment included how the wound was cleansed; safety measures included seizure, skin, or syncope precautions; all interventions/goals to reduce hospitalizations/emergency department visits; pain relief modalities included use of and directions for the long arm splint; interventions/goals for hypertension, anxiety, UTI, or syncopal episodes; or Person #23 also provided care/treatment orders for the patient. 14. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced PT was ordered once weekly (no additional disciplines were ordered), the patient’s primary diagnosis was urinary tract infection (UTI), other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life), sick sinus syndrome (a type of heart rhythm disorder), acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and dependence on supplemental oxygen (O2) (2 liters per minute [LPM] continuous, via nasal cannula [small tubes inserted into the nostrils to administer oxygen]); provide instruction regarding non-pharmacological methods of pain relief (not further specified); nutritional requirements included a 32 ounce limit for fluid intake; risks for emergent care and hospitalization included multiple recent hospitalizations/emergency department visits in the past 6 months, decline in mental, emotional, or behavioral status in the past 3 months, currently taking 5 or more medications, and “other risks” (not further specified); and stated, “... Patient was recently hospitalized for a UTI and PD [peritoneal dialysis] port infection ... also has the following co-morbidities that are new or have exacerbated within the last month ... HTN [hypertension (high blood pressure)] ... ESRD [end stage renal (kidney) disease] ... current procedures/treatment which cannot be performed by patient/caregiver due to documented lack of knowledge & or skill ... education on medication management ... Patient is further considered unstable as evidenced by ... increased low back pain ... poor balance ....” The patient’s plan of care failed to evidence diagnoses included low back pain; was individualized to include any interventions or goals related to the patient’s medical diagnoses of UTI, hypertensive heart and chronic kidney disease with heart failure and stage 5 chronic kidney disease, sick sinus syndrome, acute and chronic respiratory failure with hypoxia; patient-specific non-pharmacological methods of pain relief used; nutritional requirements included what type of diet the patient was ordered; interventions/goals for identified risks of emergent care and hospitalization, or what patient-specific “other risks” were associated with potential for emergent care and hospitalization; interventions and goals for infection prevention and control related to UTI and recent PD port infection; or the specific procedures/treatment which couldn’t be performed by patient/caregiver due to documented lack of knowledge, or associated interventions/goals. A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the PT recommended palliative care (a specialized form of care that provides symptom relief, comfort and support to individuals living with serious illnesses, and also provides support to caregivers and those impacted by a loved one’s condition). The plan of care failed to evidence psychosocial needs included the recommendation for palliative care. During an interview on 1/27/23 at 10:00 AM, at Entity #16 (a dialysis facility), Person #17 (a registered nurse [RN]) indicated the patient transferred to Entity #16 from another dialysis facility in October 2022, subsequently trained at this facility on Mondays, Wednesdays, and Fridays for peritoneal dialysis, and did backup hemodialysis at Entity #18 (a dialysis facility) on Tuesdays, Thursdays, and Saturdays. A document received from Entity #16 on 1/27/23 at 10:22 AM, titled “Limited Encounter”, evidenced Person #19 managed the patient’s hemodialysis; diagnoses included myelofibrosis (a rare type of blood cancer in which bone marrow is replaced by fibrous scar tissue) and hypotension (low blood pressure). The plan of care failed to evidence diagnoses of myelofibrosis or hypotension; and failed to evidence any information regarding the patient’s dialysis needs, or Person #19 also provided care/treatment to the patient. During an interview on 2/01/23 at 2:15 PM, the Administrator confirmed the patient’s diagnoses required interventions, she wasn’t sure why nursing services wasn’t ordered, she didn’t know why UTI was the primary diagnosis for a “therapy only” patient, there should be patient specific interventions and goals for the pertinent diagnoses, the plan of care did not include any, and there was no dialysis information on the plan of care. During an interview on 2/02/23 at 1:55 PM, the Administrator indicated family was unrealistic with palliative care, repeatedly refused palliative care, family repeatedly did not want a nurse, family thought peritoneal dialysis was going to be the answer to make the patient well, agency staff felt the patient was experiencing end of life for some time now, the patient had frequent skin tears/issues due to immobility, remained in the same position too long, and her skin was very thin/fragile. The plan of care failed to evidence patient/family psychosocial needs for coping with potential end of life situation, interventions/goals for skin issues, or interventions/goals to address the patient was left in the same position too long. The Administrator confirmed the plan of care or clinical record didn’t include this information. 15. Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document received from Entity #15 (a hospital) on 1/27/23 evidenced the patient’s allergies included NSAIDs (non-steroidal anti-inflammatory drugs to reduce pain, decrease inflammation, decrease fever, and prevent blood clots), and if used, the patient’s side effect(s) were severe, and included development of stomach ulcers. A document titled “Home Health Certification and Plan of Care” (for certification period 7/08/22 – 9/05/22), evidenced skilled nursing was ordered for one visit during the week of 7/17/22, and physical therapy (PT) was ordered weekly for 9 weeks. The document also evidenced the patient’s primary diagnosis was (idiopathic) normal pressure hydrocephalus (a condition that happens when cerebrospinal fluid builds up inside your skull and presses on your brain, which causes gait issues, urinary incontinence, and cognitive difficulties), and other diagnoses included essential (primary) hypertension (high blood pressure), and history of falling; advance directives included the patient had a durable power of attorney and a surrogate decision maker (a document that identifies an individual to make health care decisions on the patient’s behalf when he or she is no longer be able to make such decisions); the patient had no known allergies, and safety measures included 24 hour supervision was required. The plan of care failed to include patient specific interventions/goals for the patient’s diagnoses of (idiopathic) normal pressure hydrocephalus and hypertension, allergies included NSAIDs, or advance directives information included the name and/or contact information of the patient’s durable power of attorney/surrogate decision maker. A document dated 7/08/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced the patient’s diagnoses also included cerebrovascular accident (CVA)(stroke)/transient ischemic attack (TIA)(“mini-stroke”); non-pharmacological treatments for pain included use of cold application; the patient lived with a 24-hour caregiver; and the patient was fall risk, at risk for development of pressure injuries (wounds caused by unrelieved pressure or friction), and was dependent for personal care (tasks such as bathing, grooming, toileting). The plan of care failed to include diagnoses of CVA/TIA, therapeutic modalities for pain relief included cold application (and directions/precautions for use), safety measures included skin and fall precautions, or interventions/goals to meet the patient’s personal care needs. An untitled document with order date 7/16/22 (a physician’s order), evidenced the patient’s additional/exacerbated diagnoses included Von Willebrand’s Disease (a blood disorder in which the blood does not clot properly, and symptoms may include recurrent and prolonged nosebleeds, bleeding from the gums, and excessive bleeding from a cut), and Acute Panmyelosis with Myelofibrosis (in remission) (a cancer of the blood and bone marrow, which can cause excessive bleeding). The plan of care failed to include the patient’s diagnoses of Von Willebrand’s Disease or Acute Panmyelosis with Myelofibrosis (in remission). A document dated 7/16/22, titled “Visit Note Report” (RN Add-On Evaluation), evidenced non-pharmacological treatments for pain included use of heat application, the patient had generalized (affecting many parts of the body) bruising, and required frequent laboratory blood testing to monitor the patient’s blood coagulation and disease progression. The plan of care failed to include therapeutic modalities for pain relief included heat application (and directions/precautions for use), or safety measures associated with risk of excessive bleeding. During an interview on 2/02/23 at 3:45 PM, the Administrator indicated the plan of care didn’t include the name and/or contact information of the patient’s durable power of attorney/surrogate decision maker, and confirmed the plan of care should include all diagnoses, heat/cold modalities, and safety measures/precautions. 1. Record review evidenced an agency policy revised 12/1/2021, titled “Plan of Care” which stated, “… The plan of care includes: … Patient’s mental psychosocial, and cognitive status … Types, frequency, and duration of services required … Prognosis … Functional limitations and activities permitted … Nutritional requirements … Medications and treatments … Safety measures to protect against injury … Pertinent diagnoses … Patient specific interventions and education; measurable outcomes and goals … Required equipment and supplies … Patient’s risk for emergency department visits and re-hospitalization including interventions that address underlying risk factors … Patient/caregiver education and training for timely discharge … Advance Directives … All patient care orders ….” 2. Clinical record review for Patient #1 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidence a referral order dated 7/8/2022, which included the following diagnoses which were not included in the plan of care: hypersomnia (excessive sleepiness), chronic constipation, recurrent urinary tract infections (bladder infections), and risk for imbalanced fluid volume. Clinical record review evidenced a plan of care for certification period 1/10/2023 – 3/10/2023, which indicated the patient was taking modafinil (medication to increase alertness), senna (stool softener), Dulcolax (for constipation), and cranberry tablets (to prevent urinary tract infections). During an interview on 1/31/2023, at 3:18 PM, administrator/clinical manager #1 indicated plans of care should have included all pertinent diagnoses from the referral documentation or history and physical. 3. Observation of a home visit for Patient #2 was conducted on 1/25/2023, at 10:00 AM, to observe a routine skilled nurse visit. During the visit, the following medical equipment was observed in use in the home, and not included on the plan of care: cane, rocksteady device, grabber, and shower chair. Clinical record review for Patient #2 was completed on 2/2/2023, for certification period 11/30/2022 – 1/28/2023. Record review evidenced a referral order/history and physical dated 11/30/2022, which included the following diagnoses which were not included in the plan of care: hypertension (high blood pressure), hyperlipidemia (high cholesterol), and cardiac arrythmia (irregular heart beat). Clinical record review evidenced a plan of care for certification period 11/30/2022 – 1/28/2023, which indicated the skilled nurse was to instruct the patient on care of an indwelling catheter, including signs and symptoms of infection, and instruct the client on infection control measures. This document failed to include patient specific education regarding infection control, such as type of infection control measures, methods of infection control, or specific signs and symptoms the patient should look for. The plan of care failed to include patient specific instructions regarding indwelling catheter care. During an interview on 1/31/2023, at 10:27 AM, administrator/clinical manager #1 indicated the plan of care should have been more detailed and include patient specific education on indwelling catheter care. At 10:29 AM, administrator/clinical manager #1 indicated all medical equipment the patient was using should have been included on the plan of care. 4. Clinical record review for Patient #3 was completed on 2/2/2023, for certification period 12/8/2022 – 2/5/2023. Record review evidenced a history and physical dated 12/17/2022, which included a diagnosis of vertigo (spinning sensation), which was not included on the plan of care. 5. Clinical record review for Patient #4 was completed on 2/2/2023, for certification period 1/20/2023 – 3/20/2023. Record review evidenced a start of care assessment dated 1/20/2023, which indicated the patient had a diagnosis of chronic obstructive pulmonary disease (disease which results in progressively worsening ability to breathe). Clinical record review evidenced a plan of care for certification period 1/20/2023 – 3/20/2023, which failed to include a diagnosis of chronic obstructive pulmonary disease. During an interview on 1/31/2023, at 12:25 PM, administrator/clinical manager #1 indicated the plan of care should have included chronic pulmonary obstructive disease. 6. Clinical record review for Patient #5 was completed on 2/2/2023, for certification period 12/21/2022 – 2/18/2023. Record review evidenced a referral document dated 8/24/2022, which included a diagnosis of obstructive sleep apnea (low oxygen levels while sleeping), which was not included on the plan of care. 7. Clinical record review for Patient #7 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/2/2022 – 1/30/2023, which indicated the patient was receiving isosource 1.5 cal tube feedings, and also Jevity 1.5 tube feedings. During an interview on 1/30/2023, at 2:29 PM, administrator/clinical manager #1 indicated they did not know which tube feed the patient was receiving, but this information should have been included on the plan of care. 8. Clinical record review for Patient #8 was completed on 2/2/2023, for certification period 1/5/2023 – 3/5/2023. Record review evidenced a history and physical dated 1/10/2023, which included the following diagnoses which were not included in the plan of care: dysphagia (inability to swallow), and gastrostomy tube status (tube inserted through the skin of the abdomen into the stomach for nutrition and medications). Clinical record review evidenced a plan of care for certification period 1/5/2023 – 3/5/2023, which indicated the patient was to receive tube feeding as follows: Isosource 1.5, 6 – 8 bottles per day, at 750 milliliters per hour. The plan of care failed to include nutritional information such as total volume per day, if tube feed was bolus or continuous, free water flush information, or how many hours tube feeding would infuse. The plan of care indicated the physical therapist was to complete wound care but failed to include any wound care orders such as frequency of dressing changes, type of dressing, or any instructions for wound care. During an interview on 1/30/2023, at 2:40 PM, administrator/clinical manager #1 indicated all pertinent diagnoses should be included on the plan of care. Administrator/clinical manager #1 indicated the diagnoses are usually obtained from the history and physical or referral documentation. At 2:45 PM, administrator/clinical manager #1 indicated they were not sure if the tube feeds were continuous or bolus, and additional information should have been included on the plan of care. Administrator/clinical manager #1 indicated wound care orders should have been included on the plan of care. 9. Clinical record review for Patient #9 was completed on 2/2/2023, for certification period 7/24/2022 – 9/21/2022. Record review evidenced a physical therapy evaluation note dated 8/26/2022, which indicated the patient had been using a walker, which was not included in the plan of care. Clinical record review evidenced a history and physical dated 6/28/2022, which included the following diagnoses which were not included on the plan of care: lymphoid cancer (cancer of the lymphatic system), gilbert syndrome (a disorder in which the liver doesn’t properly process bilirubin), atrial fibrillation (disease in which the heart beats irregularly), osteoporosis (weakening of the bones), heart failure, and hyperlipidemia (high cholesterol). This document also indicated the patient was taking 1 can of ensure (nutritional supplement), which was not included on the plan of care. Clinical record review evidenced a plan of care for certification period 7/24/2022 – 9/21/2022, which indicated physician #17 was the patient’s physician. During an interview on 2/1/2023, at 10:13 AM, administrator/clinical manager #1 indicated physician #17 was retired, and the plan of care should have included physician #18. Administrator/clinical manager #1 indicated the diagnoses and nutritional supplements should have been included on the plan of care.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure treatments were administered only as ordered by the physician in 1 of 7 home visits conducted. (#3) The findings include: Record review evidenced an agency policy revised 12/1/2022, titled “Physician Orders” which stated, “… No medications, treatments, diagnostic studies or therapeutics will be administered without the order of a qualified physician or authorized practitioner ….” Clinical record review for Patient #3 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/8/2022 – 2/5/2023, which did not include any wound care orders. Clinical record review evidenced a skilled nursing visit note dated 1/16/2023, which indicated the patient had a new wound to right great toe. This visit note indicated the nurse cleansed the toe and applied a dressing to the site. Record review failed to evidence any physician orders for wound treatment. During an interview on 1/31/2023, at 12:20 PM, administrator/clinical manager #1 indicated the nurse should have provided wound care only as ordered on the plan of care or called the physician to receive a wound care order. 410 IAC 17-13-1(a)

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to review and revise the plan of care in 3 of 7 home visits conducted. (#1, 3, 5) The findings include: 1. Record review evidenced an agency policy revised 12/1/2021, titled “Plan of Care” which stated, “… Physician/authorized practitioner’s orders are obtained to updated the plan of care and may include problems and goals … Alterations to the plan of care are made only with the physician/authorized practitioner’s approval … the patient is monitored for response to treatment and progress toward goals … Case conference with staff involved in patient’s care is held for each patient at least every 60 days: the plan of care is then reviewed, revised, and sent to the physician ….” 2. Clinical record review for Patient #1 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a skilled nurse visit note dated 12/16/2022, which indicated all patient’s wounds were healed, and the physician was made aware of healed wound status. Clinical record review evidenced a skilled nurse visit note dated 12/27/2022, which indicated the patient’s coccyx (area at base of spine, above tailbone) wound had re-opened, and measured 1.5 cm (centimeters) x 1 cm x 0.1 cm. Record review failed to evidence the plan of care was reviewed or revised to address worsened wound status. During an interview on 1/31/2023, at 10:07 AM, administrator/clinical manager #1 indicated the plan of care should have been revised to address the enlarging wound. 3. Clinical record review for Patient #3 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/8/2022 – 2/5/2023, which indicated the patient’s primary diagnosis was urinary tract infection. Clinical record review evidenced a coordination note dated 1/4/2023, which indicated the patient was hospitalized on 12/18/2022, for cellulitis. Clinical record review evidenced a resumption of care assessment dated 1/10/2023, which indicated the patient had been hospitalized for cellulitis. Clinical record review evidenced a plan of care for certification period 12/8/2022 – 2/5/2023, which failed to have been revised to include the new diagnosis of cellulitis, or any additional revisions focused on cellulitis. During an interview on 1/31/2023, at 12:14 PM, administrator/clinical manager #1 indicated the clinician should have updated the plan of care at the time of the resumption of care. 4. Clinical record review for Patient #5 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/21/2022 – 2/18/2023, which indicated the patient’s heart rate normal parameters were between 50 to 90 [normal heart rate is 60 - 100]. Clinical record review evidenced skilled nurse visit notes for the following dates, in which the patient’s heart rate was outside of parameters: 12/16/2022, 12/24/2022, 12/30/2022, 1/7/2023, 1/13/2023, 1/20/2023, and 1/27/2023. Clinical record review evidenced a skilled nurse visit note dated 12/24/2022, which indicated the patient’s heart rate was 111, which was normal for the patient. Clinical record review failed to evidence the plan of care was updated or revised to reflect accurate vital sign parameters. During an interview on 1/31/2023, at 12:43 PM, administrator/clinical manager #1 indicated the plan of care should have been revised to reflect current heart rate parameters for the patient.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to promptly alert the relevant physician to any changes in the patients’ conditions or needs which suggested outcomes were not being achieved and/or the plan of care should have been altered in 10 of 17 clinical records reviewed. (#1, 2, 3, 5, 6, 9, 12, 13, 16, 17). The findings include: 8. A home visit was observed on 1/27/23 at 2:00 PM with Patient #12, PTA #2, and the Alternate Clinical Manager. The patient indicated she was unable to get her blood drawn yesterday (1/26/23) for her weekly PT/INR (to monitor therapeutic level of blood thinner medication), she went every Thursday for the blood draw, and she was very worried about it because her warfarin dose changed a lot. The patient also indicated she was dehydrated, her irritable bowel syndrome (IBS) (an intestinal disorder causing pain in the belly, gas, diarrhea, and constipation) was flaring up, and she had new onset significant pain. PTA #2 called the certifying physician and reported the patient’s pain, but failed to report the patient missed her lab draw, she was dehydrated, or her IBS was flaring up. During an interview on 2/01/23 at 11:18 AM, the Administrator indicated all of the findings from the home visit should have been reported to the physician. 9. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s primary diagnosis was urinary tract infection (UTI), other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life), sick sinus syndrome (a type of heart rhythm disorder), acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and dependence on supplemental oxygen (O2) (2 liters per minute [LPM] continuous, via nasal cannula [small tubes inserted into the nostrils to administer oxygen]). A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced no skin issues/problems were identified, and the patient had 2+ pitting edema (swelling that occurs when excess fluid builds up in the body due to heart, circulatory, and/or kidney problems, and when pressed by the tip of a finger, a “pit” remains; 1+ means the “pit” leaves an indentation of 0–2 millimeters [mm] that rebounds immediately; 2+ means the “pit” leaves an indentation of 3–4 mm that rebounds in fewer than 15 seconds; 3+ means the “pit” leaves an indentation of 5–6 mm that takes up to 30 seconds to rebound; and 4+ means the “pit” leaves an indentation of 8 mm or deeper that takes more than 20 seconds to rebound) to both lower extremities. A document dated 11/30/22, titled “Visit Note Report” (Physical Therapy Assistant [PTA] routine visit), indicated the patient sustained a skin tear on the right hip, it was covered with a bandage, and the patient had 3+ bilateral lower extremity edema (worse than previous visit). The document failed to evidence the physician was notified. A document dated 12/07/22, titled “Visit Note Report” (PTA routine visit) evidenced the patient had 3-4+ pitting edema to both lower extremities (worse than last routine visit), and stated, “... [family] reports R [right] buttocks skin tear covered with bandage, reports changed bandage no bleeding noted, patient has bruising at face, UES [upper extremities] that have been long standing ....” The document failed to evidence the physician was notified. A document dated 12/15/22, titled “Visit Note Report” (PT reassessment) evidenced an assessment section, which indicated cardiovascular assessment was “NA” (not applicable), post intervention of pain was “NA”, and the patient did not have a diagnosis or symptoms indicative of respiratory impairment. The document failed to evidence the physician was notified. A document dated 12/21/22, titled “Visit Note Report” (PTA routine visit), evidenced new skin tears to the patient’s left forearm and right middle finger, the right hip/buttock wound was healing, family addressed the wounds, the patient had 3+ edema to both feet, and used O2 at 2 LPM. The document failed to evidence the physician was notified. A document dated 12/28/22, titled “Visit Note Report” (PTA routine visit), stated, “... [patient/family] mention having a lot [more] fluid due to having to change dialysis routine and patient is a little boated feeling today. Mentions usually [only] wears supplement oxygen at night but has it on today due to mild shortness of breath without supplemental oxygen ... edema in BLE [bilateral lower extremities] being controlled per [family] ....” The clinical record failed to evidence a comprehensive reassessment was completed for the patient’s significant decline in health status. The document failed to evidence the physician was notified. A document dated 1/05/23, titled “Visit Note Report” (transfer data collected, no visit made) evidenced the patient utilized the emergency department and was admitted to the hospital. A document received from Entity #15 (a hospital) on 1/27/23, titled “Emergency Documentation” evidenced the patient was seen at Entity #15’s emergency department, was diagnosed with a UTI, and was admitted for treatment on 12/30/22. During an interview on 2/01/23 at 2:15 PM, the Administrator indicated the patient was declining and the physician should have been notified. 10. Clinical record review for Patient #17 was completed on 2/02/23 (start of care date 7/08/22). A document dated 7/08/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced no abnormal gastrointestinal (stomach/intestinal), integumentary (skin), cardiovascular (heart, blood vessels), or neurological (brain, spinal cord, and nerves) findings were identified. A document dated 7/16/22, titled “Visit Note Report” (RN Add-On Evaluation), evidenced gastrointestinal assessment findings included abdominal pain in all four quadrants (all areas of the abdomen), and nausea/vomiting; integumentary findings included generalized (affecting many parts of the body) bruising; neurological assessment findings included dizziness, vertigo (a sensation of whirling and loss of balance), headache, and numbness of both upper extremities; cardiovascular assessment findings the patient’s legs were pale, cool to touch with ruddy (reddish in color)/cyanotic (blue/purple skin color due to lack of oxygen) color to tips, with weak pulses bilaterally (both lower legs), and slightly edematous (swelling due to excess fluid buildup) without pitting (when pressure is applied to the swollen area, a “pit”, or indentation, will remain); and stated “... care coordination ... indicate if you communicated with ... individuals involved with this case ... no ....” The document failed to evidence the physician was notified for the worsening edema. A document dated 7/22/22, titled “Visit Note Report” (PT routine visit) evidenced family requested a Speech Language Pathology (SLP) evaluation due to the patient’s cognitive changes (ability to comprehend, remember, and reason). The document failed to evidence the cognitive changes, or the physician was notified. A document titled “Home Health Certification and Plan of Care” (for certification period 7/08/22 – 9/05/22), evidenced Person #7 was the patient’s certifying physician. A document dated 8/18/22, titled “Visit Note Report” (PT routine visit), evidenced the patient had an appointment with Person #10 (a neurosurgeon), and the patient was going to have a drain placed to decrease fluid on the brain. The document failed to evidence Person #7 was notified. During an interview on 2/02/23 at 3:45 PM, the Administrator indicated the plan of care didn’t include the name and/or contact information for Person #10, or evidence Person #7 was aware Person #10 also wrote treatment orders for Patient #17. 1. Record review evidenced an agency policy revised 8/1/2019, titled “Coordination of Care, From Admit through Discharge” which stated, “… Coordination of care with physician: … throughout care … coordination of services is promoted through routine communication with the patient’s physician: … When changes occur I the patient’s condition or response to treatment … When changes occur in caregiver support or the environment that affect patient treatment … When there is a need to change the patient’s plan of care ….” 2. Clinical record review for Patient #1 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a skilled nurse visit note dated 12/16/2022, which indicated all patient’s wounds were healed, and the physician was made aware of healed wound status. Clinical record review evidenced a skilled nurse visit note dated 12/27/2023, which indicated the patient’s coccyx (area at base of spine, above tailbone) wound had re-opened, and measured 1.5 cm (centimeters) x 1 cm x 0.1 cm. Record review failed to evidence the physician was notified of the patient’s change in condition. Clinical record review evidenced a recertification assessment dated 1/7/2023, which indicated the patient’s coccyx wound now measured 2 cm x 2 cm x 0.1 cm. The assessment indicated the wound appeared to be deteriorated from the last skilled nurse assessment. Record review failed to evidence the physician was notified of the deterioration of the patient’s wound. Clinical record review evidenced a skilled nurse visit note dated 1/11/2023, which indicated the patient’s coccyx wound now measured 2.2 cm x 2 cm 2 x 0.1 cm. Record review failed to evidence the physician was notified of the enlarging wound. Clinical record review evidenced a skilled nurse visit note dated 1/19/2023, which indicated the patient’s coccyx wound now measured 5 cm x 1 cm x 0.1 cm. Record review failed to evidence the physician was notified of the enlarging wound. During an interview on 1/31/2023, at 10:05 AM, administrator/clinical manager #1 indicated the physician should have been contacted regarding the patient’s wound opening up, deteriorating, and enlarging, so they could add wound care orders to the plan of care. 3. Clinical record review for Patient #2 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 11/30/2022 – 1/28/2023, which indicated physician #11 was the physician overseeing the plan of care. Clinical record review evidenced a skilled nurse visit note dated 12/30/2022, which indicated the patient’s urologist was physician #12. Clinical record review evidenced a physician order dated 1/3/2023, and signed by physician assistant #13, which included an order for the home health agency to change the patient’s catheter. Clinical record review failed to evidence physician #11 was notified of the need to change the plan of care. During an interview on 1/31/2023, at 10:19 AM, administrator/clinical manager #1 indicated the physician listed on the plan of care should have been notified of any changes in orders on the plan of care from other physicians. 4. Clinical record review for Patient #3 was completed on 2/2/2023, for certification period 12/8/2022 – 2/5/2023. Record review evidenced a skilled nurse visit note dated 1/16/2023, which indicated the patient had a new wound to the right great toe but failed to evidence the physician was notified of the change in patient status. During an interview on 1/31/2023, at 12:21 PM, administrator/clinical manager #1 indicated the physician should have been notified of the new wound and need to update the plan of care. 5. Clinical record review for Patient #5 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/21/2022 – 2/18/2023, which indicated the clinician was to notify the physician for heart rate greater than 90. Clinical record review evidenced skilled nurse visit notes for the following dates, during which the patient’s heart rate was greater than 105, and the physician was not notified: 12/16/2022, 12/24/2022, 12/30/2022, 1/7/2023, and 1/13/2023. During an interview on 1/31/2023, at 12:43 PM, administrator/clinical manager #1 indicated the physician should have been notified every visit the heart rate was outside of parameters. 6. Observation of a home visit for Patient #6 was conducted on 1/31/2023, at 4:00 PM, to observe a routine physical therapy visit. During the visit, the patient was observed to have moderate swelling to lower extremities. Clinical record review for Patient #6 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a start of care assessment dated 1/10/2023, which did not indicate the patient had any swelling to lower extremities, and indicated the patient had no wounds. Clinical record review evidenced an occupational therapy visit note dated 1/13/2023, which indicated the patient had new bilateral lower extremity swelling but failed to indicate the physician was notified of the change in patient status. Clinical record review evidenced a physical therapy visit note dated 1/24/2023, which indicated the patient now had 1 + swelling to lower extremities (2 millimeters of indentation on skin when pressed, which rebounds immediately), but failed to evidence the physician was notified of new swelling. Clinical record review evidenced an occupational therapy visit note dated 1/25/2023, which indicated the patient now had redness to his buttocks along the tailbone. Record review failed to evidence the physician was notified of new wound/area of redness. During an interview on 1/31/2023, at 1:12 PM, administrator/clinical manager #1 indicated the physician should have been notified of the swelling and new area of redness. 7. Clinical record review for Patient #9 was completed on 2/2/2023, for certification period 7/24/2022 – 9/21/2022. Record review evidenced a skilled nurse visit note dated 7/28/2022, which indicated the patient was non-compliant with taking metoprolol (medication to lower heart rate and blood pressure). Record review failed to evidence the physician was notified of the change in medication compliance. During an interview on 2/1/2023, at 10:17 AM, administrator/clinical manager #1 indicated the physician should have been notified of medication non-compliance.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to coordinate care delivery to meet the patient’s needs in 5 of 17 clinical records reviewed. (#1, 2, 12, 13, 16). The findings include: 4. A home visit was observed on 1/27/23 at 2:00 PM with Patient #12, PTA #2, and the Alternate Clinical Manager. The patient indicated she was unable to get her blood drawn yesterday (1/26/23) for her weekly PT/INR (to monitor therapeutic level of blood thinner medication), she went every Thursday for the blood draw, she was very worried about it because her warfarin dose changed a lot, the patient indicated she informed the wound clinic that home care was coming today, and the wound clinic was waiting for a call back. PTA #2 failed to contact the patient’s wound clinic during the visit. During an interview on 2/01/23 at 11:18 AM, the Administrator indicated she didn’t know which coumadin clinic the patient went to, or who the physician was. 5. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 12/03/22 – 1/31/23). A document dated 1/02/23, titled “Visit Note Report” (PTA routine visit) stated, “... Patient ... mentions ... having an aide come today to help with shower and cleaning of home ...." During an interview on 2/02/23 at 2:33 PM, the Administrator indicated the aide wasn’t from their agency, and she didn’t know who it was. 6. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life). A document received from Entity #16 (a dialysis facility) on 1/27/23 at 10:22 AM, titled “Limited Encounter”, evidenced Person #19 managed the patient’s hemodialysis. During an interview on 1/27/23 at 10:00 AM at Entity #16 (a dialysis facility), Person #17 (a registered nurse [RN]) indicated he started seeing the patient in October (2022), the patient trained at this facility on Mondays, Wednesdays, and Fridays for peritoneal dialysis, did backup hemodialysis at Entity #18 (a dialysis facility) on Tuesdays, Thursdays, and Saturdays, didn’t know the patient had home health services, and didn’t receive any communication from the agency. During an interview on 1/27/23 at 10:00 AM at Entity #16, Person #20 (a RN, who trained patients for home peritoneal dialysis) indicated she was unaware the patient had home health services. During an interview on 2/01/23 at 2:15 PM, when queried how the agency coordinated care with Entity #16, the Administrator indicated they ask the patients what days they go to dialysis. 1. Record review evidenced an agency policy revised 8/1/2019, titled “Coordination of Care, From Admit through Discharge” which stated, “… The agency provides care and services within an integrated continuum of care system … This is accomplished by: … Coordinating patient are among various disciplines to ensure that services are continuous and coordinated from admission through discharge ….” 2. Observation of a home visit for Patient #1 was conducted on 1/25/2023, at 8:30 AM, to observe a routine skilled nurse visit. The patient was observed to be bedbound, alert and oriented, but totally dependent. During the visit, a caregiver from home health agency #8 was present. Person #9 (caregiver from home health agency #8) indicated they were in the patient’s home 7 days per week, 4 hours in the morning, and 2 hours in the evenings. Person #9 indicated they provided the patient with bathing, transfers, activities of daily living, and wound care if needed. Clinical record review for Patient #1 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 1/10/2023 – 3/10/2023, which failed to include any information on home health agency #8, or services provided to the patient by the other home health agency. The plan of care included the following wound care for a wound to the coccyx (area at the base of the spine): cleanse with normal saline, pat dry with gauze, apply calcium alginate with silver to wound bed, cover with foam dressing. Review failed to evidence any care coordination notes or documentation about home health agency #8. Clinical record review evidenced a faxed plan of care from home health agency #8, which was obtained on 1/25/2023. This document indicated the home health agency was providing home health aide care 7 days per week for activities of daily living. This document indicated the home health aide was to apply Desitin (skin protective cream), and Neosporin (antibiotic ointment) to the sacral (area right above the tailbone) area 3 times daily to heal the skin, which were not included on the agency’s plan of care. During an interview on 1/31/2023, at 10:03 AM, administrator/clinical manager #1 indicated if the patient was receiving care from another home health agency, it should have been noted in the medical record or plan of care, that the patient was receiving care from another agency. Administrator/clinical manager #1 indicated the medical record should have included information on how many hours the other agency was providing care to the patient, and information for follow-up communication between the agencies. Administrator/clinical manager #1 indicated the staff should have been coordinating care with other home health agencies providing care. At 10:11 AM, administrator/clinical manager #1 indicated they should have coordinated care with the other home health agency to find out what services they were providing in the home and to compare orders. 3. Observation of a home visit for Patient #2 was conducted on 10/25/2023, at 9:45 AM, to observe a routine skilled nurse visit. During the visit, the patient was observed to be alert and oriented, and wheelchair bound. There was a caregiver from home health agency #14 present at the time of the visit. The patient indicated the home health aide assisted with bathing, transfers, and activities of daily living. Clinical record review evidenced a plan of care from home health agency #14, dated 1/25/2023, which indicated the patient was to receive 36 hours of home health aide services per week. Clinical record review failed to evidence there was any care coordination with the other home health agency.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide patients with written schedules in 3 of 7 home visits conducted. (#1, 4, 12). The findings include: 4. A home visit was observed on 1/27/23 at 2:00 PM with Patient #12, PTA #2, and the Alternate Clinical Manager. The home folder failed to evidence a visit schedule. The patient asked PTA #2 when the next visit was, and PTA #2 responded to the patient that it would be next week, and no further information was provided to the patient. 1. Record review evidenced an agency policy revised 8/1/2019, titled “Coordination of care, From admit through discharge” which stated, “… Written information obtained from the plan of care will be provided to the patient and caregiver outlining: … Visit schedule including frequency of visits by agency staff and contract workers ….” 2. Observation of a home visit for Patient #1 was conducted on 1/25/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s home binder was reviewed, which failed to include a visit schedule. During an interview on 1/31/2023, at 9:50 AM, administrator/clinical manager #1 indicated the patients should have received a calendar in the admission booklet, and the staff should have filled that out. 3. Observation of a home visit for Patient #4 was conducted on 1/27/2023, at 10:15 AM, to observe a routine skilled nurse visit. During the visit, the patient’s home binder was reviewed, which failed to include a visit schedule.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure patients received written medication instructions which included the medication name, dosage, and frequency of medications in 6 of 7 home visits conducted. (#1, 2, 3, 4, 5, 6) The findings include: 1. Record review evidenced an agency policy revised 8/1/2019, titled “Coordination of care, From admit through discharge” which stated, “… Written information obtained from the plan of care will be provided to the patient and caregiver outlining: … Medication schedule/instructions including: medication name, dosage, and frequency, and which medications will be administered by agency staff and/or contract workers ….” 2. Observation of a home visit for Patient #1 was conducted on 1/25/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles and home binder were reviewed, which contained a list of home medications. The list of medications failed to include the following medications the patient was taking: ibuprofen (for pain/fever) and topiramate (to prevent seizures) 100 milligrams twice daily. The medication list included sertraline (antidepressant) 100 milligrams once daily, and modafinil (medication to increase alertness), which the patient was not taking. During an interview on 1/31/2023, at 9:38 AM, administrator/clinical manager #1 indicated the patients should have had an accurate medication list in their homes, which included all medications they were taking including the correct dosage and frequency. 3. Observation of a home visit for Patient #2 was conducted on 1/25/2023, at 10:00 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles and home binder were reviewed. The home binder contained a list of home medications. The list of medications failed to include the following medications the patient was taking: iron, vitamin B12, and folic acid. 4. Observation of a home visit for Patient #3 was conducted on 1/26/2023, at 10:00 AM, to observe a routine occupational therapy visit. During the visit, the patient’s medication bottles and home binder were reviewed, which contained a list of home medications. The list of medications included the following medications the patient was not taking: aspirin, benzonatate, tizanidine, and tramadol 50 milligrams every 4 hours as needed for pain. The medication list failed to include ciprofloxacin, which the patient was taking. 5. Observation of a home visit for Patient #4 was conducted on 1/27/2023, at 10:15 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles and written home medication list were reviewed. Review evidenced the following medication bottles which were not included on the written medication list: ipratropium bromide nasal spray and ibuprofen. 6. Observation of a home visit for Patient #5 was conducted on 1/27/2023, at 8:30 AM, to observe a routine skilled nurse visit. During the visit, the patient’s medication bottles and a written medication list were reviewed. Review evidenced the following medication bottles which were not included on the patient’s written medication list: oxycodone-acetaminophen 10-325 milligrams every 6 hours as needed for pain, pepcid, baclofen 10 milligrams twice daily, and probiotic. 6. Observation of a home visit for Patient #6 was completed on 1/30/2023, at 4:00 PM, to observe a routine physical therapy visit. During the visit, the patient’s medication bottles and a written medication list were reviewed. Review of the bottles evidenced the patient was taking flomax 0.4 milligrams twice daily and atorvastatin 10 milligrams twice daily. Review of the medication list indicated the patient was taking flomax 0.4 milligrams once daily, and atorvastatin 10 milligrams once daily. During the visit, the patient indicated they were using a barrier cream, for an open area to their buttock. This barrier cream failed to be included on the written medication list.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure patients received in writing any treatments to be administered by home health agency personnel or personnel acting on behalf of the home health agency in 2 of 7 home visits observed (#4, 12). The findings include: A home visit was observed on 1/27/23 at 2:00 PM with Patient #12, PTA #2, and the Alternate Clinical Manager. The home folder failed to evidence a plan of care. Record review evidenced an agency policy revised 8/1/2019, titled “Coordination of Care, From Admit Through Discharge” which stated, “… Written information obtained from the plan of care will be provided to the patient and caregiver outlining: … Treatments to be administered by staff or contract workers, including therapy services ….” Observation of a home visit for Patient #4 was conducted on 1/27/2023, at 10:15 AM, to observe a routine skilled nurse visit. During the visit, a home health binder was reviewed, which failed to include a plan of care or written treatment instructions. During an interview on 1/31/2023, at 12:30 PM, adminsitrator/clinical manager #1 indicated the patient should have received a written plan of care summary.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the performance improvement activities led to an immediate correction of any identified problems which directly or potentially threatened the health and safety of patients. The findings include: Record review on 1/27/2023, evidenced an agency document dated 11/3/2022, titled “Quality assessment and Performance Improvement Team Meeting Minutes” which stated, “… Purpose: The QAPI [quality assurance performance improvement] meeting is conducted quarterly and will ensure measurable improvement in indicators for which there is evidence that the improvement led to improved health outcomes, safety and quality of care for patients ….” Review of the agency’s QAPI program on 1/27/2023, evidenced a QAPI executive summary for the 3rd quarter of 2022, which indicated the agency had 48 falls per 412 patients, or a 12% fall rate for the 3rd quarter. This document indicated 1 patient fell 6 times, 1 patient fell 4 times, and 3 patients fell 3 times in the third quarter. This document indicated the agency was implementing fall recovery education and documentation of root cause of falls to address the falls. Review of the agency’s QAPI program on 1/27/2023, evidenced a QAPI executive summary for the 4th quarter of 2022, which indicated the agency had 57 falls per 453 patients, and a 13% rate of falls. This document indicated there were 4 patients with multiple falls, and the agency was implementing fall recovery education and documentation of root cause of falls. Record review failed to evidence documentation of the root cause of falls, as indicated in the QAPI program. Record review failed to evidence the fall recovery education and root cause analysis of falls led to an immediate correction of the fall rate, or patients falling multiple times. During an interview on 1/27/2023, at 2:49 PM, administrator/clinical manager #1 indicated the agency discussed every morning on a phone huddle the root cause of any falls but indicated the root cause analysis discussion was not documented. 410 IAC 17-12-2(a)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review, and interview, the home health agency failed to ensure skilled professionals accurately prepared clinical notes and assessments in 11 of 17 clinical records reviewed (#1, 2, 3, 5, 7, 8, 9, 13, 14, 15, 16). The findings include: 6. Clinical record review for patient #13 was completed on 2/02/23 (start of care date 10/04/22, certification period 12/03/22 – 1/31/23). A document dated 12/13/22, titled “Visit Note Report” (PT Reassessment without OASIS data set), evidenced the patient reported pain as “5” (on a scale of 0-10, with 0=no pain and 10= worst pain possible), and stated, “... Patient reports she twisted her right knee while getting in and out of a vehicle on Saturday [12/10/22] ... has been experiencing significant pain with the right knee area ever since ... does not want to go to the emergency room ... she is now using the wheelchair for most mobility ... unable to safely use walker ....” The document failed to evidence assessment of the knee occurred. A document dated 12/19/22, titled “Visit Note Report” (PTA routine visit) indicated the patient’s right knee remained painful at a “6”, and she was going Wednesday (12/21/22) to have it checked out (no further information). The document failed to evidence assessment of the knee occurred. A document dated 12/27/22, titled “Visit Note Report” (PT reassessment without OASIS data) indicated the patient used over the counter and prescription medications for pain relief, the patient’s fear of falling was a high concern, and stated, “... Patient reports she did have a consult ortho [orthopedic] due to right knee pain ... ortho suspects a fracture ... continued pain ... difficult time getting around ... occasional assistance ....” The document failed to evidence assessment of the knee occurred. A document dated 1/02/23, titled “Visit Note Report” (PTA routine visit) stated, “... Patient ... has MRI tomorrow for [right] knee ... presents [with] right knee brace on ... was not on appropriately ....” The document failed to evidence assessment of the knee occurred. A document dated 1/12/23, titled “Visit Note Report” (PTA routine visit) stated, “... Patient had [physician] appointment Tuesday [1/10/23] with [Person #29, an orthopedic physician] ... [patient to] wear [right] knee brace for two weeks then begin [outpatient] therapy ... remain [non-weight bearing right lower leg] ... has a fracture ....” The document failed to evidence assessment of the knee occurred. During an interview on 2/02/23 at 2:33 PM, the Administrator indicated the patient should have been reassessed. 7. Clinical record review for patient #14 was completed on 2/02/23 (start of care date 10/27/22, certification period 10/27/22 – 12/25/22). A document dated 10/17/22, titled “... Order Category: Dietary, Pharmacy ... Active Orders As Of ... 10/17/22”, evidenced the document originated from Entity #25 (a skilled nursing facility). The document listed the patient’s current diagnoses, which included obstructive and reflux uropathy (a disorder of the urinary tract that occurs due to obstructed urinary flow), UTI, dysphagia, oropharyngeal phase (difficulty initiating a swallow, and swallowing may be accompanied by regurgitation, aspiration [the drawing in of a foreign substance into the lungs], and a sensation of residual food remaining in the throat), need for assistance with personal care, other symptoms and signs concerning food and fluid intake, and stage 2 pressure ulcer, other site (characterized by partial-thickness skin loss into but no deeper than the layers of the skin, which includes intact or ruptured blisters). A document dated 10/14/22, titled “[Entity #25] ... Progress Notes”, evidenced the patient’s lung sounds improved with crackles (sounds heard when the small air sacs in the lungs fill with fluid and there's air movement in the sacs during breathing) since she was started on Lasix (a diuretic), and family had an appointment with Entity #27 (an oxygen and medical equipment company) for training on BiPap (a device that helps with breathing, and forces intermittent air into the lungs), and colace (stool softener) was added twice daily for constipation. A document titled “Home Health Certification and Plan of Care” (for initial certification period 10/27/22 – 12/25/22), evidenced the patient’s primary diagnosis was acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and additional diagnoses included pneumonitis due to inhalation of food and vomit (an infection of the lungs caused by inhaling saliva, food, liquid, vomit and even small foreign objects into the lungs), sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues), type 2 diabetes (adult onset), dementia, and dependence on supplemental oxygen; and medications included oxygen at 4 LPM via nasal cannula (tubes inserted into the nose), and colace twice daily. A document dated 10/27/22, titled “Visit Note Report” (PT start of care comprehensive assessment), evidenced assessment findings, which indicated the patient had no skin problems, no cardiovascular problems, the only respiratory issue was the use of O2 at 2 LPM via nasal cannula, no urinary problems, no gastrointestinal problems, the patient didn’t have diabetes, and there were no nutritional risks. The document failed to evidence the PT assessed the patient’s heart, lung or bowel sounds, pedal (feet) pulses, performed a diabetic foot exam, assessed how often the patient checked her blood sugar level, identified the location or assessed the stage 2 pressure ulcer, assessed weight, correct O2 dose was 4 LPM, assessed ability to safely swallow, ability to urinate, signs or symptoms of UTI, or signs/symptoms of aspiration. A document dated 11/03/22, titled “Visit Note Report” (PTA routine visit), failed to evidence the location of the stage 2 pressure ulcer. An additional document dated 11/03/22, titled “Visit Note Report” (RN add-on evaluation), evidenced the patient had wound(s), but no further assessment was documented; the patient had a CPap (a device that helps with breathing, and forces continuous air into the lungs); the patient used O2 at 3 LPM; and the patient didn’t have diabetes. The document failed to evidence the RN assessed the patient’s heart, lung or bowel sounds, pedal (feet) pulses, performed a diabetic foot exam, assessed how often the patient checked her blood sugar level, identified the location or assessment of the stage 2 pressure ulcer, assessed weight, correct O2 dose was 4 LPM, assessed ability to safely swallow, ability to urinate, signs or symptoms of UTI, or signs/symptoms of aspiration. A document dated 11/08/22, titled “Visit Note Report” (PTA routine visit), failed to evidence the the location of the stage 2 pressure ulcer. An additional document dated 11/08/22, titled “Visit Note Report” (LPN routine visit) failed to evidence the the location of the stage 2 pressure ulcer. On 2/02/23 at 3:01 PM, during the clinical record review, the Administrator confirmed adequate assessments weren’t performed based on the patient’s diagnoses. 8. Clinical record review for patient #15 was completed on 2/02/23. A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s primary diagnosis was laceration without foreign body of other part of head, subsequent encounter (unspecified open wound of unspecified part of head), and other diagnoses included fracture of right elbow, and UTI; medications included levetiracetam (an anti-seizure medication); and stated, “... Patient ... medical history is significant for frequent falls [and hypertension [high blood pressure] ... patient attributes frequent falls to syncopal [fainting] episodes ....” A document dated 12/28/22, titled “History and Physical Reports” (Entity #15, a hospital), evidenced the patient had a witnessed syncopal (fainting) episode and sustained a laceration (cut) to the back of her head; urinalysis (laboratory test of urine) was positive for UTI, the patient was started on antibiotics, and urine cultures were pending (to pinpoint the best antibiotic treatment based on the pathogen identified in the urine). A document dated 1/09/23, titled “Outpatient Surgical Report/Discharge Summary”, evidenced the patient had surgery to repair the right elbow on 1/09/23, and staples were used to close the skin. A document dated 11/13/22, titled “Visit Note Report” (PT start of care comprehensive assessment), failed to evidence the patient’s head was assessed, was assessed for any seizure or syncopal activity, or signs/symptoms of UTI. A document dated 1/16/23, titled “Visit Note Report” (PT routine visit), failed to evidence the patient’s head was assessed, was assessed for any seizure or syncopal activity, or signs/symptoms of UTI. A document dated 1/18/23, titled “Visit Note Report” (PT reassessment visit), failed to evidence the patient’s head was assessed, was assessed for any seizure or syncopal activity, or signs/symptoms of UTI. A document dated 1/23/23, titled “Visit Note Report” (PTA routine visit), evidenced the patient’s staples were removed from the right elbow on 1/20/23, and the incision was covered with a dressing (type not specified). The document failed to evidence the patient’s right elbow or head was assessed, assessed for any seizures or syncopal activity, or signs/symptoms of UTI. During an interview on 2/02/23 at 3:30 PM, the Administrator indicated the patient’s head wasn’t assessed, wasn’t assessed for any seizure or syncopal activity, signs/symptoms of UTI, and stated, “... I see this is a problem ....” 9. Clinical record review for Patient #16 was completed on 2/01/23 (start of care date 11/20/22). A document with printed date 11/14/22, titled “History and Physical Report”, indicated the patient had permacath (a long, flexible tube [catheter] that is inserted into a vein most commonly into a large vein in the neck, and less commonly into a large vein in the groin, for dialysis) placement on 3/11/22, and peritoneal catheter (a tube that is inserted into the lining of the abdomen to filter blood within the body during dialysis) placement on 10/18/22. A document titled “Home Health Certification and Plan of Care” (for initial certification period 11/20/22 – 1/18/23), evidenced the patient’s primary diagnosis was urinary tract infection (UTI), other diagnoses included hypertensive heart (problems with the heart that can develop if you have high blood pressure but don't treat it for years) and chronic kidney disease (long-standing decline of kidney function) with heart failure (the heart’s inability to pump blood and oxygen [O2] throughout the body) and stage 5 chronic kidney disease (end stage, requires dialysis to sustain life), sick sinus syndrome (a type of heart rhythm disorder), acute (sudden) and chronic (long standing) respiratory failure with hypoxia (the respiratory system cannot adequately provide oxygen to the body, resulting in an absence of enough oxygen in the tissues to sustain bodily functions), and dependence on supplemental oxygen (O2) (2 liters per minute [LPM] continuous, via nasal cannula [small tubes inserted into the nostrils to administer oxygen]). A document dated 11/20/22, titled “Visit Note Report” (PT start of care comprehensive assessment) evidenced no skin issues/problems were identified, and the patient had 2+ pitting edema (swelling that occurs when excess fluid builds up in the body due to heart, circulatory, and/or kidney problems, and when pressed by the tip of a finger, a “pit” remains; 1+ means the “pit” leaves an indentation of 0–2 millimeters [mm] that rebounds immediately; 2+ means the “pit” leaves an indentation of 3–4 mm that rebounds in fewer than 15 seconds; 3+ means the “pit” leaves an indentation of 5–6 mm that takes up to 30 seconds to rebound; and 4+ means the “pit” leaves an indentation of 8 mm or deeper that takes more than 20 seconds to rebound) to both lower extremities. A document dated 11/30/22, titled “Visit Note Report” (Physical Therapy Assistant [PTA] routine visit), indicated the patient sustained a skin tear on the right hip, it was covered with a bandage, and the patient had 3+ bilateral lower extremity edema (worse than previous visit). The document failed to evidence the patient’s O2 saturation (an assessment device that measures how much O2 is in your blood) level, weight, lung sounds, pedal (pulses on the top of the feet) pulses, signs/symptoms of UTI, the skin tear on the right hip, or integrity of the permacath and peritoneal catheters were assessed. A document dated 12/07/22, titled “Visit Note Report” (PTA routine visit) evidenced the patient had 3-4+ pitting edema to both lower extremities (worse than last routine visit), and stated, “... [family] reports R [right] buttocks skin tear covered with bandage, reports changed bandage no bleeding noted, patient has bruising at face, UES [upper extremities] that have been long standing ....” The document failed to evidence the patient’s weight, lung sounds, pedal pulses, signs/symptoms of UTI, the skin tear on the right hip, or integrity of the permacath and peritoneal catheters were assessed/measured as indicated. A document dated 12/15/22, titled “Visit Note Report” (PT reassessment) evidenced an assessment section, which indicated cardiovascular assessment was “NA” (not applicable), post intervention of pain was “NA”, and the patient did not have a diagnosis or symptoms indicative of respiratory impairment. The document failed to evidence the patient’s O2 saturation, assessment for edema, pedal pulses, weight, lung sounds, right buttocks skin tear, facial and upper extremities bruising, signs/symptoms of UTI or integrity of the permacath and peritoneal catheters were assessed/measured as indicated. A document dated 12/21/22, titled “Visit Note Report” (PTA routine visit), evidenced new skin tears to the patient’s left forearm and right middle finger, the right hip/buttock wound was healing, family addressed the wounds, the patient had 3+ edema to both feet, and used O2 at 2 LPM. The document failed to evidence the patient’s O2 saturation, pedal pulses, weight, lung sounds, right buttocks skin tear, skin tears to the patient’s left forearm and right middle finger, facial and upper extremities bruising, signs/symptoms of UTI or integrity of the permacath and peritoneal catheters were assessed/measured as indicated. A document dated 12/28/22, titled “Visit Note Report” (PTA routine visit), stated, “... [patient/family] mention having a lot [more] fluid due to having to change dialysis routine and patient is a little boated feeling today. Mentions usually [only] wears supplement oxygen at night but has it on today due to mild shortness of breath without supplemental oxygen ... edema in BLE [bilateral lower extremities] being controlled per [family] ....” The document failed to evidence the patient’s pedal pulses, weight, lung sounds, right buttocks skin tear, skin tears to the patient’s left forearm and right middle finger, facial and upper extremities bruising, signs/symptoms of UTI or integrity of the permacath and peritoneal catheters were assessed/measured as indicated. A document dated 1/05/23, titled “Visit Note Report” (transfer data collected, no visit made) evidenced the patient utilized the emergency department and was admitted to the hospital, but failed to evidence why the patient was hospitalized. A document received from Entity #15 (a hospital) on 1/27/23, titled “Emergency Documentation” evidenced the patient was seen at Entity #15’s emergency department, was diagnosed with a UTI, and was admitted for treatment on 12/30/22. A document received from Entity #15 on 1/27/23, titled “History and Physical Reports”, evidenced the patient was discharged from Entity #15 on 1/02/23. A document received from Entity #15 on 1/27/23, titled “Discharge Summary”, evidenced admit/discharge diagnoses included UTI and weakness. During an interview on 2/01/23 at 2:15 PM, the Administrator indicated she expected the patient to be assessed every visit based on the diagnoses. 1. Record review evidenced an agency policy revised 8/1/2022, titled “Wound Assessment, Documentation, and Photography” which stated, “… Wound location and description documentation is completed on all patients with wounds at the time of admit or upon development of a wound … Wound assessment findings will be documented within the Integumentary Command Center by utilizing the Wound Assessment Tool … During routine visits, wound will be documented in the Wound Assessment Tool ….” 2. Record review evidenced a registered nurse job description obtained 2/1/2023, which stated, “… Accurately and thoroughly documents patient visits per policy ….” 3. Clinical record review for Patient #1 was completed on 2/2/2023, for certification period 1/10/2023 – 3/10/2023. Record review evidenced a skilled nurse visit note dated 1/11/2023, which inicated the patient had a wound which measured 2.2cm (centimeters) x 2cm x 0.1cm. Clinical record review evidenced a skilled nurse visit note dated 1/19/2023, which indicated the wound now measured 5cm x 1cm x 0.1cm. This visit note indicated the wound was getting smaller. During an interview on 1/31/2023, at 10:09 AM, administrator/clinical manager #1 indicated the documetnation was inaccurate regarding the wound getting smaller. 4. Observation of a home visit for Patient #2 was conducted on 1/25/2023, at 10:00 AM, to observe a routine skilled nurse visit. During the visit, the nurse failed to assess the patient’s blood glucose level. Clinical record review for Patient #2 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 11/30/2022 – 1/28/2023, which indicated the patient had a primary diagnosis of diabetes (problem regulating blood sugar levels). Clinical record review evidenced skilled nurse visit notes for the following dates, which failed to include an assessment of blood glucose levels: 11/30/2022, 1/6/2023, 1/13/2023, and 1/25/2023. Record review evidenced a start of care assessment dated 11/30/2022, which indicated the patient had wounds, and also indicated the patient had no wounds. This document indicated the patient had an indwelling catheter which was changed on 11/25/2022. Clinical record review evidenced a skilled nurse visit note dated 12/30/2022, which indicated the indwelling catheter was changed on 11/23/2022. During an interview on 1/31/2023, at 10:29 AM, administrator/clinical manager #1 indicated the nurses should have checked/assessed the patient’s blood glucose level every visit. At 10:39 AM, administrator/clinical manager #1 indicated the documentation of wounds was contradictory. At 10:41 AM, administrator/clinical manager #1 indicated the 12/30/2022, skilled nurse visit note documented the catheter change date in error. 5. Clinical record review for Patient #3 was completed on 2/2/2023, for certification period 12/8/2022 – 2/5/2023. Record review evidenced a skilled nurse visit note dated 1/16/2023, which indicated the patient had a new wound to the right great toe, but failed to include measurements, or documentation in the wound assessment tool as per policy. The visit note failed to document what type of dressing was applied, or with what the wound was cleansed. Clinical record review evidenced a skilled nurse visit note dated 1/23/2023, which indicated the patient had a new wound to the left buttock but failed to include a wound assessment including site appearance, measurements, drainage, or type of wound. During an interview on 1/31/2023, at 12:23 PM, administrator/clinical manager #1 indicated the nurse should have documented what dressing was applied and with what the wound was cleansed with. Administrator/clinical manager #1 did not know what wound care was provided. Administrator/clinical manager #1 indicated wounds should have been measured and assessed every visit and documented in the wound tool. 6. Clinical record review for Patient #5 was completed on 2/2/2023. Record review evidenced a plan of care which indicated the nurse was to complete wound care weekly and assess wound site for complications or progress. Clinical record review evidenced a skilled nurse visit note dated 1/7/2023, which failed to include wound measurements. During an interview on 1/31/2023, at 12:46 PM, administrator/clinical manager #1 indicated the wound should have been measured every visit. 7. Clinical record review for Patient #7 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 12/2/2022 – 1/30/2023, which indicated the patient was to receive skilled nursing for assessment and instruction regarding indwelling catheter care, and assessment and instruction of gastrostomy tube (tube inserted into stomach to deliver feedings). Clinical record review evidenced skilled nurse visit notes for dates 12/16/2022, and 12/21/2022, which failed to include an assessment of patient’s gastrostomy tube status. During an interview on 1/30/2023, at 2:21 PM, administrator/clinical manager #1 indicated the clinicians should have completed a head-to-toe assessment every visit, and assessed the gastrostomy tube site. 8. Clinical record review for Patient #8 was completed on 2/2/2023. Record review evidenced a plan of care for certification period 1/5/2023 – 3/5/2023, which indicated the physical therapist was to provide wound care, instruct the patient on wound care, and reinforce wound care teaching to patient. The plan of care indicated the patient had a pressure ulcer on the coccyx (tailbone). Clinical record review evidenced physical therapy visit notes dated 1/11/2023, 1/25/2023, and 1/27/2023, which all failed to include assessment of wound such as wound measurements, dressing applied, frequency of dressing changes. The visit note dated 1/27/2023, failed to include any wound assessment. During an interview on 1/30/2023, at 2:48 PM, administrator/clinical manager #1 indicated any wounds should have been assessed and measured weekly. 9. Clinical record review for Patient #9 was completed on 2/2/2023, for certification period 7/24/2022 – 9/21/2022. Record review evidenced a skilled nurse visit note dated 8/16/2022, which indicated the patient had no falls since the last visit, and also indicated the patient had fallen on 8/14/2022. Clinical record review evidenced a skilled nurse visit note dated 8/12/2022, which indicated the patient had no integumentary issues, and in another section indicated the patient had bruising from eyebrows down to the collar bone. During an interview on 2/1/2023, at 10:05 AM, administrator/clinical manager #1 indicated it was contradictory documentation, and probably not accurate. At 10:15 AM, administrator/clinical manager #1 indicated the 8/12/2022, skilled nurse visit note was not accurate.

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 home health agency failed to ensure skilled professionals communicated with all physicians involved in the plan of care in 1 of 5 discharged clinical records reviewed. (#9) The findings include: Record review evidenced an agency policy revised 8/1/2019, titled “Coordination of Care, From Admit Through Discharge” which stated, “… Coordination of care with physician: … At admission, throughout care, and at discharge, coordination of services is promoted through routine communication with the patient’s physician ….” Clinical record review for Patient #9 was completed on 2/2/2023. Clinical record review evidenced a plan of care for certification period 7/24/2022 – 9/21/2022, which indicated the patient’s physician was physician #17. Clinical record review evidenced a communication note dated 8/9/2022, which indicated the patient fell 3 times, and physician #18 was notified. Clinical record review evidenced a physician order dated 8/12/2022, to delay a physical therapy visit per spouse’s request, which was sent to physician #18. Clinical record review evidenced a communication note dated 8/16/2022, which indicated the patient fell, and physician #18 was notified. Clinical record review evidenced a missed visit note dated 8/19/2022, which was sent to physician #18. Clinical record review evidenced a communication note dated 8/19/2022, with abnormal urinalysis results, which were sent to physician #18. During an interview on 2/1/2023, at 10:13 AM, administrator/clinical manager #1 indicated they did not know why the clinicians were not communicating with the physician listed on the plan of care. 410 IAC 17-14-1(a)(1)(G)