Community Home Care Services Inc.

“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: the plan of care was individualized to meet the patient needs (see tag G0570), the plan of care was followed by all agency staff as directed by the primary care physician (see tag G0572), the plan of care contained all required elements for their patients (see tag G0574), services and treatments were provided only as ordered by the physician (see tag G0580), the plan of care was reviewed / revised by the physician every 60 days, at minimum (see tag G0588), the home health agency staff promptly alerted the primary care physician to changes in the patient’s condition (see tag G0590), the plan of care was revised to reflect the current health status and nursing needs of the patient (see tag G0592), care was coordinated by all disciplines (see tag G0606), patients / caregivers received written copies of instructions (see tag G0612), patients / caregivers were provided a written schedule of visits (see tag G0614), patients / caregivers were provided written medication schedule / instructions (see tag G0616), patients / caregivers were provided written information about treatments provided (see tag G0618), and patients were provided with the name and contact information of the agency’s clinical manager (see tag G0622). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination, Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on observation, record review, and interview, the agency failed to provide services to meet the patient’s needs in 5 of 7 records reviewed (Patient #1, 3, 4, 5, 6). The findings include: 1. During a home visit on 6/6/2024 at 9:20 AM, Patient #1 was observed to have tremors, generalized weakness, shortness of breath with exertion and poor balance. While attempting to put on their shoes, the Patient needed to take breaks to sit up and take deep breaths in order to complete the task. A review of the start of care assessment dated 5/15/2024 evidenced the Patient had Parkinson’s, required assistance with grooming and dressing, was weak, had tremors, and a history of falls. The assessment indicated the Patient did not refuse home health aide services. A review of an X-ray report from Hospital 1 on 5/10/2024 evidenced the Patient had chest trauma and an acute rib fracture after a fall at home. During an interview on 6/6/2024 at 10:05 AM, Person 2 (family member of Patient #1) indicated the Patient had fallen 5 or 6 times in the past 3 months, and they had to call an ambulance for assistance each time. Person 2 indicated the Patient had their own physical problems that made it difficult to help the Patient, but they did the best they could. Person 2 indicated the Patient had difficulty trying to bathe, and Person 2 had difficulty trying to help them. Person 2 indicated when he asked for getting help for the Patient with bathing and dressing, the agency referred them to Agency 3, which they would have to pay for out of pocket and could not afford. During an interview on 6/10/2024 at 12:15 PM, the Administrator indicated the agency did not offer Home Health Aide services, and if a patient required them, they would either have a nurse provide the care needed or refer the patient to another agency for the services. When informed of the findings, the Administrator indicated they did not know the patient would have to pay out of pocket for services from Agency 3. The Administrator indicated they needed to talk to the clinician about the situation because the patient’s needs should be met. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week but failed to evidence the patient was informed about and consented to the change in nursing visit frequency. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the clinician should have ensured the patient consented to the change in frequency of nurse visits and documented this, but she did not find this in the Patient’s record. 3. A clinical record review indicated physical therapy was to evaluate and treat Patient #6 for post-knee replacement care. The nurse performed the start of care visit on 5/3/2024, and the PT (Physical Therapy) evaluation was done on 5/6/2024. The Patient was scheduled for 2 PT visits per week. A clinical record review evidenced one PT visit was performed on the week of 5/12/2024 to 5/18/2024 and failed to evidence any PT visits were performed the following week. The skilled nurse discharged the Patient on 5/24/2024. A review of the referral information from Hospital 7 evidenced orders for the Patient to receive home health for skilled nursing, physical therapy, and occupational therapy. A clinical record review evidenced the Patient received no occupational therapy and no routine skilled nursing visits. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated most post-knee replacement patients get 3 PT visits a week, but the Patient agreed to 2 PT visits per week because they had a previous knee replacement and knew what to expect. PT 2 indicated they should see the patient for the initial evaluation within 24 to 48 hours of the start of care or receipt of the therapy order and they did not know why there was a delay in starting therapy for the Patient. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated PT 3 was supposed to do the initial PT evaluation on 5/4/2024, but he never showed up. The Patient indicated they were supposed to get 3 PT visits per week, but PT 2 changed it to twice a week. The Patient indicated they did not know why and did not want less than 3 visits per week. The Patient indicated they requested to be discharged from the agency because they were not getting the therapy they needed and wanted to go to therapy at the hospital. During an interview on 6/11/2024 at 1:21 PM, Administrative Staff 2 indicated the initial PT evaluation should have been done within 48 hours of the admission, or there should be documentation explaining the delay, but the Patient’s record failed to evidence such documentation. When informed of the findings, Administrative Staff 2 indicated the agency failed to meet the Patient’s needs. XX. The agency policy titled “Patient Admission Criteria”, revised 2/2021, indicated if the agency is not able to provide the needed care, the agency will assist and notify the referral source. The clinical record of Patient #7 evidenced a start of care date of 2/8/24 for a care period of 2/8/24 to 4/7/24 with a discharge on 3/6/24. Discharge documentation indicated a comment that Patient requested early discharge. The record failed to evidence that Patient was referred to other agencies or that the physician was notified of Patient’s discharge. The clinical record of Patient #7 evidenced the comprehensive assessment completed on 2/8/24 which indicated Patient needs assistance to complete all activities of daily living and has a history of falls. During an interview on 6/11/24 beginning at 11:00 AM, Other 4, the son/daughter and emergency contact for Patient #7, relayed Patient did not request discharge and was told by the nurse that the agency could no longer meet Patient’s needs. Other indicated Patient #7 lived alone. During an interview on 6/10/24 beginning at 11:15AM, Administrator relayed if the agency could not provide appropriate care the patient would be referred to another agency. During an interview on 6/11/24 beginning at 11:00, Administrative staff 2 could not find documentation that Patient #7 was given referrals to other resources or agencies. 410 IAC 17-13-1(a) 1. During a home visit on 6/6/2024 at 9:20 AM, Patient #1 was observed to have tremors, generalized weakness, shortness of breath with exertion and poor balance. While attempting to put on their shoes, the Patient needed to take breaks to sit up and take deep breaths in order to complete the task. A review of the start of care assessment dated 5/15/2024 evidenced the Patient had Parkinson’s, required assistance with grooming and dressing, was weak, had tremors, and a history of falls. The assessment indicated the Patient did not refuse home health aide services. A review of an X-ray report from Hospital 1 on 5/10/2024 evidenced the Patient had chest trauma and an acute rib fracture after a fall at home. During an interview on 6/6/2024 at 10:05 AM, Person 2 (family member of Patient #1) indicated the Patient had fallen 5 or 6 times in the past 3 months, and they had to call an ambulance for assistance each time. Person 2 indicated the Patient had their own physical problems that made it difficult to help the Patient, but they did the best they could. Person 2 indicated the Patient had difficulty trying to bathe, and Person 2 had difficulty trying to help them. Person 2 indicated when he asked for getting help for the Patient with bathing and dressing, the agency referred them to Agency 3, which they would have to pay for out of pocket and could not afford. During an interview on 6/10/2024 at 12:15 PM, the Administrator indicated the agency did not offer Home Health Aide services, and if a patient required them, they would either have a nurse provide the care needed or refer the patient to another agency for the services. When informed of the findings, the Administrator indicated they did not know the patient would have to pay out of pocket for services from Agency 3. The Administrator indicated they needed to talk to the clinician about the situation because the patient’s needs should be met. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week but failed to evidence the patient was informed about and consented to the change in nursing visit frequency. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the clinician should have ensured the patient consented to the change in frequency of nurse visits and documented this, but she did not find this in the Patient’s record. 3. A clinical record review indicated physical therapy was to evaluate and treat Patient #6 for post-knee replacement care. The nurse performed the start of care visit on 5/3/2024, and the PT (Physical Therapy) evaluation was done on 5/6/2024. The Patient was scheduled for 2 PT visits per week. A clinical record review evidenced one PT visit was performed on the week of 5/12/2024 to 5/18/2024 and failed to evidence any PT visits were performed the following week. The skilled nurse discharged the Patient on 5/24/2024. A review of the referral information from Hospital 7 evidenced orders for the Patient to receive home health for skilled nursing, physical therapy, and occupational therapy. A clinical record review evidenced the Patient received no occupational therapy and no routine skilled nursing visits. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated most post-knee replacement patients get 3 PT visits a week, but the Patient agreed to 2 PT visits per week because they had a previous knee replacement and knew what to expect. PT 2 indicated they should see the patient for the initial evaluation within 24 to 48 hours of the start of care or receipt of the therapy order and they did not know why there was a delay in starting therapy for the Patient. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated PT 3 was supposed to do the initial PT evaluation on 5/4/2024, but he never showed up. The Patient indicated they were supposed to get 3 PT visits per week, but PT 2 changed it to twice a week. The Patient indicated they did not know why and did not want less than 3 visits per week. The Patient indicated they requested to be discharged from the agency because they were not getting the therapy they needed and wanted to go to therapy at the hospital. During an interview on 6/11/2024 at 1:21 PM, Administrative Staff 2 indicated the initial PT evaluation should have been done within 48 hours of the admission, or there should be documentation explaining the delay, but the Patient’s record failed to evidence such documentation. When informed of the findings, Administrative Staff 2 indicated the agency failed to meet the Patient’s needs. 4. A clinical record review for Patient #3 evidenced a comprehensive assessment dated 5/8/2024 which indicated the patient lived alone and required assistance for grooming. The comprehensive assessment indicated the patient had a non-skilled caregiver 2 days a week from Entity 3 for bathing and light housekeeping and a had a family member that visited every 2 weeks. Review indicated the patient required a walker for ambulation, was at risk for falls, and had a history of falls. On 6/6/2024, at 12:40 PM, the patient indicated he/she paid out-of-pocket for a caregiver 2 days a week to assist with bathing and housekeeping. The patient indicated the agency did not offer to provide home health aide services and indicated home health aide services through the agency could reduce the cost the patient paid out-of-pocket for a caregiver. On 6/7/2024, at 11:55 AM, Person 5 at Entity 3 indicated Entity 3 was a personal services agency and did not provide home health aide services. On 6/7/2024, beginning at 2:30 PM, the Administrator indicated she was unaware Entity 3 was a personal services agency and was not providing a home health aide. The Administrator indicated the patient had Medicare, which would cover home health aide services if needed, and was not aware the patient was paying out-of-pocket for a caregiver. The Administrator indicated the agency could not find any home health aides to hire. Requested recruitment effort documentation for home health aides and no additional information or documentation was provided prior to survey exit on 6/11/2024. 5. A clinical record review for Patient #4 evidenced a referral document from Entity 9 dated 4/3/2024, which indicated the patient needed home health services to include occupational therapy (OT) services. The start of care comprehensive assessment dated 4/9/2024 indicated the patient required assistance with grooming, dressing, and toilet hygiene. Review failed to evidence the agency provided OT services or provided the patient with contact information for agencies to provide OT services. The comprehensive assessment indicated the patient lived in an assisted living facility (ALF) and failed to evidence what services the ALF provided regarding the patient’s need for assistance with grooming, dressing, and toilet hygiene. The comprehensive assessment for the recertification on 6/4/2024, completed by Registered Nurse (RN) 1, indicated the ALF did not provide assistance with activities of daily living (ADLs) and the patient’s family lived out of state. The comprehensive assessment dated 6/4/2024 indicated the patient had redness and cellulitis (a deep infection of the skin) to the right leg and required Minerin cream (moisturizer) to be applied daily to both legs. The comprehensive assessment dated 6/42024 indicated the patient was unable to apply the cream and the ALF did not provide that type of care. The plan of care for 6/8/2024-8/6/2024 indicated Minerin cream was to be applied daily to both legs and indicated the agency would provide skilled nursing 1 time weekly. Review failed to evidence the agency provided services to meet the patient’s needs to have the cream applied daily. On 6/10/2024, at 1:26 PM, the Administrator indicated the agency could not provide OT services due to staffing and the patient was not provided contact information for other agencies to provide OT services. The Administrator indicated home health aide services were not provided to the patient to assist with ADLs, because the Administrator believed the ALF was providing ADL assistance. On 6/11/2024, at 11:40 AM, the patient indicated they could not reach their legs to apply cream and indicated the ALF helped with meals and laundry and not personal care. On 6/11/2024, at 10:01 AM, RN 1 indicated the ALF could not apply the cream and did not assist the patient with ADLs. RN 1 indicated the patient did not feel confident about being able to apply the cream to the legs, and RN 1 indicated she needed to address the needs of the patient with the ALF. On 6/11/2024, beginning at 10:45 AM, the Administrator-in-Training indicated the agency determined the frequency of the disciplines provided based on patient’s need, staff availability, and insurance coverage. The Administrator-in-Training indicated if the patient required care 7 days a week, and the insurance allowed it, the agency would have to provide services 7 days a week to meet the patient’s need. The Administrator-in-Training indicated the patient had a managed Medicare plan which required authorization for requested home health visits and indicated the agency had only requested skilled nurse visits 2 times a week. 410 IAC 17-13-1(a)”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on record review and interview, the administrator failed to: ensure the organizational structure was readily identifiable and included the lines of authority and services provided; appoint in writing a qualified administrator in conjunction with the Governing Body in the administrator’s absence; ensure the accuracy of public information; notify the regulatory entities of administrative staff changes; and ensure the Clinical Manager was coordinating the assignment of personnel and patients and referrals. The findings include: XX. During an interview on 6/7/24 beginning at 2:00 PM, RN 1 indicated that Administrator is her current administrator and clinical director and Administrative staff 2 is her Director of Nursing (DON). 1. Review of a policy titled “Administrator: Defined” revised February 2022 indicated the Administrator’s responsibilities included, but were not limited to, ensuring the accuracy of public information and appointing a similarly qualified alternate to be available in the administrator’s absence and authorized in writing by the Governing Body. 2. Review of a policy titled “Supervision of Staff” revised March 2018 indicated the Clinical Manager’s responsibilities included, but were not limited to, developing personnel assignments. 3. Review of the administrative information in iQIES and on file with the Indiana Department of Health indicated Person 8 was the agency administrator. The Governing Body Meeting Minutes dated 12/11/2023 indicated the Administrator was the interim administrator effective 12/1/2023. During an interview at the entrance conference on 6/5/2024, beginning at 11:25 AM, the Administrator indicated the agency provided services by a physical therapy assistant and did not provide medical social worker, speech therapy, and home health aide services. The Administrator indicated Person 8 terminated employment with the agency 4-5 months ago and indicated she was unaware she needed to notify the Indiana Department of Health that she was the interim administrator until the Administrator-in-Training was trained. 4. Review of the agency brochure found inside the patient admission packet indicated the agency provided services to Lake, Porter, Newton, and Jasper counties. Review of the survey document “Geographic Area Served” dated 6/5/2024 failed to evidence the agency provided services to Lake, Porter, Newton, and Jasper counties. On 6/11/2024, at 1:48 PM, the Administrator-in-Training indicated the agency did not provide services in Lake, Porter, Newton, and Jasper counties but the counties were included on the brochure, because the other two agencies in Indiana managed by Entity 10 covered those counties. Review of the agency’s website www.visitingnurse.com indicated the agency provided home health aide services. 5. Review of the undated organizational chart on 6/5/2024 failed to evidence the services provided by and the lines of authority for the physical therapy assistant. The organizational chart included services provided by speech therapy, home health aide, and medical social worker. The organizational chart evidenced the Administrator was the interim administrator. On 6/5/2024, beginning at 2:09 PM, the Administrator indicated the website should be updated to remove home health aide services and indicated the organizational chart should include the services provided by the physical therapy assistant and the discipline would report to the physical therapist. The Administrator indicated the agency did not provide home health aide and medical social work services as indicated by the organizational chart. On 6/11/2024, at 9:59 AM, Registered Nurse (RN) 2 indicated the Administrator-in-Training was the Clinical Manager. 6. On 6/6/2024, at 3:10 PM, and on 6/11/2024, at 11:55 AM, a request was made to the Administrator for the written authorization for the Alternate Administrator by the Governing Body and Administrator in the administrator’s absence. On 6/11/2024, at 1:48 PM, the Administrator-in-Training indicated there was no documentation provided by the Administrator for the written authorization by the Governing Body and Administrator for the alternate administrator. 7. On 6/11/2024, at 12:07 PM, the Clinical Manager indicated he did not provide oversight of the assignment of patients to clinicians and indicated the Office Manager assigned the patients to staff. The Clinical Manager indicated he was in the office 1 day every 2 weeks and was not involved in the patient referrals. The cumulative effect of these systemic problems has resulted in the home health agency’s inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.105 Organization and Administration of Services. 410 IAC 17-12-1(d) 410 IAC 17-12-1(a)(1) 410 IAC 17-12-1(b)(1) 410 IAC 17-12-1(c)(4) 410 IAC 17-14-1(a)(1)(K)”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on observation, interview, and record review the agency failed to provide an updated and revised comprehensive assessment as a patient condition warranted in 1 of 1 clinical record reviewed of a home visit of a patient with a wound (Patient #2). Findings include: In an observation during a home visit on 6/7/24 starting at 1:00 PM, Patient #2 was observed with wound dressings to the left foot, right foot, and right lower leg. The clinical record for Patient #2 evidenced a skilled nurse visit note completed on 6/1/24 by RN 1 which indicted three wounds: on the left heel, on the right lower leg, and the right 2nd toe. The summary noted new wound formation to the right lower leg and right second toe. The last comprehensive assessment was completed 5/14/24. The record failed to evidence a new comprehensive assessment to reflect the new wounds. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 relayed a comprehensive reassessment should be completed after any changes are noted in a patient’s condition such as a new wound or a fall. 410 IAC 17-14-1(a)(1)(B)”

“Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge planning was followed per agency policy in 1 of 1 closed record reviewed. The findings include: A review of a policy titled “Discharge Criteria and Planning” revised April 2023 indicated the patient would be informed of discharge plan in a timely manner, the physician would be notified of discharge, and the agency will provide the patients with discharge instructions and contact numbers of other agencies who could provide services to the patient. The clinical record of Patient #7 evidenced a start of care date of 2/8/24 for a care period of 2/8/24 to 4/7/24 with a discharge on 3/6/24. Discharge documentation indicated Patient requested early discharge. The record failed to evidence that Patient was referred to other agencies or that the physician was notified of Patient’s discharge. The discharge comprehensive assessment completed on 3/8/24 indicated the patient needed assistance to complete all activities of daily living and had a history of falls. During an interview on 6/11/24 beginning at 11:00 AM, Other 4, family member and emergency contact for the patient, relayed the patient did not request discharge and was told by the nurse that the agency could no longer meet the patient’s needs. Other 4 indicated the patient lived alone. During an interview on 6/10/24 beginning at 11:15AM, the Administrator relayed if the agency could not provide appropriate care the patient would be referred to another agency. During an interview on 6/11/24 beginning at 11:00, the Alternate -in- Training could not find documentation that Patient #7 was given referrals to other resources or agencies.”

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on record review and interview the agency failed to provide discharge summary to the receiving health care practitioner to ensure a safe and effective transition of care in 2 of 2 closed clinical records reviewed (Patient #6, 7). Findings include: XX. The agency policy titled “Discharge Summary”, revised in February of 2021 indicates a discharge summary will be sent to the primary care practitioner within five days of discharge. The clinical record of Patient #7 failed to evidence documentation that a discharge summary was provided to Patient’s physician. During an interview on 6/10/24 beginning at 12:15PM, Administrator was unable to locate documentation that a discharge summary was sent to the physician. 410 IAC 17-13-2(a)(b)(9) XX. A review of the discharge summary dated 5/24/2024 indicated Patient #6 was discharged due to goals met. A clinical record review failed to evidence the Patient’s goals were met, and they had not been evaluated by a physical therapist since the initial evaluation on 5/6/2024. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated they requested to be discharged from the agency because they were not getting the therapy they needed, and wanted to go to therapy at the hospital. During an interview on 6/11/2024 at 1:31 PM, Administrative Staff 2 indicated the Patient’s goals were not met, and the discharge summary failed to evidence why the patient was discharged.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to evidence services were provided as directed in the plan of care in 4 of 7 clinical records reviewed. (Patient #1, 4, 6, 7) The findings include: XX. The agency policy titled “Plan of Care – CMS #485 and Physician/Practitioners Orders,” revised 4/2023, indicates each plan of care should include patient specific interventions, education, measurable outcomes and goals which are individualized based on medical diagnosis, orders, comprehensive assessment and patient input. The clinical record of Patient #2 evidenced a plan of care for care period 5/17/24 to 7/15/24 that indicated Patient has nicotine dependence (cigarettes), and chronic obstructive pulmonary disease (lung disease) with the use of ongoing supplemental oxygen. The plan of care goals failed to evidence interventions and goals related to Patient’s safety related to smoking and use of oxygen. education or interventions related to smoking. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 relayed there should be an interventions and goal related to smoking cessation. The clinical record for Patient #7 evidenced a start of care/initial comprehensive assessment on 2/8/24 which indicated Patient had diagnoses of Atrial fibrillation (an irregular heart rhythm), hypertensive (referring to high blood pressure) heart disease with heart failure, congestive heart failure (heart muscle doesn’t pump as well as it should, may cause swelling), and diabetes mellitus type 2 (disease with high blood sugar). The plan of care for certification period 02/8/24 to 4/7/24 included 22 goals specific to Patient. Skilled nursing notes dated 2/13/24, 2/22/24, and 2/29/24 failed to evidence any individualized goals addressed with Patient other than symptoms to report to physician. 410 IAC 17-13-1(a) A clinical record review for Patient #4 evidenced a plan of care for 4/9/2024-6/7/2024 which indicated the agency would provide physical therapy (PT) services 2 times a week for 3 weeks and then 1 time a week for 4 weeks. Review failed to evidence the agency provided any PT services during the week of 5/5/2024. On 6/10/2024, at 1:45 PM, the Administrator indicated there was a PT missed visit on 5/10/2024 and no other PT visits were provided during the week. 1. A review of the plan of care for Patient #1, certification period, 5/15/2024 to 7/13/2024 evidenced the following orders: physical therapy twice a week for four weeks, then once a week for four weeks and physician notification for pulse oximeter (oxygen level) less than 92%. A clinical record review evidenced the Patient received one physical therapy visit for the week of 5/26/2024 to 6/1/2024. A physical therapy visit note dated 5/23/2024 evidenced the Patient’s pulse oximeter reading was 90% but failed to evidence physician notification. During an interview on 6/6/2024 at 9:41 AM, PTA (Physical Therapy Assistant) 1 indicated if a patient’s vital signs were out of range, they would notify the nurse case manager and document it in the visit note. During an interview on 6/10/2024 at 12:09 PM, the Administrator indicated the PTA should have communicated the pulse oximeter reading with the nurse case manager or the supervising physical therapist who would have contacted the physician. The Administrator indicated the Patient’s record failed to evidence the physician was notified of the patient’s pulse oximeter reading. 2. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 evidenced the physician should be notified if Patient #6’s pulse oximeter (oxygen level) reading was less than 92% and if their pain level was greater than 7 out of 10. The plan of care evidenced PT (Physical Therapy) was to evaluate and treat the patient but failed to evidence a frequency of visits. A clinical record review failed to evidence a PT plan of care that had been signed by the physician. Clinical record review evidenced the following findings not reported to the physician as ordered in the plan of care: The PT evaluation dated 5/6/2024 evidenced the Patient had constant pain, rated 8 out of 10; a physical therapy note dated 5/10/2024 evidenced the Patient’s pulse oximeter reading was 90%. During an interview on 6/11/2024 at 1:20 PM, Administrative Staff 2 indicated the clinical record failed to evidence the physician was notified of the out of range pain level and pulse oximeter readings. During an interview on 6/11/2024 at 11:40 AM, PT 2 indicated they did not communicate with the physician about Patient #6.”

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Governing Body approved the frequency and detail of the data collection of the quality assurance performance improvement (QAPI) program. The findings include: The agency’s QAPI binder, Governing Body minutes from 2023 to current, and the contract with Entity 11 were reviewed and failed to evidence documentation of the frequency and detail of the data collection approved by the Governing Body. On 6/10/2024, at 3:22 PM, the Administrator indicated there was no documentation in the QAPI binder regarding the Governing Body approval of the frequency and detail of the data collection and indicated maybe it was in the contract with Entity 11. 410 IAC 17-12-2(a)”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the quality assurance performance improvement (QAPI) program’s performance improvement activities focused on high risk and problem-prone areas. The findings include: 1. An undated document titled “Hospitalizations” reviewed on 6/11/2024 indicated 10 patient hospitalizations in December 2023 and January 2024. No additional hospitalizations were provided prior to December 2023 or after January 2024. The hospitalization log failed to evidence tracking information to include the dates of and admitting diagnosis for the hospitalization. A clinical record review for Patient #1 evidenced the patient was hospitalized in May 2024 following a fall and a urinary tract infection. The hospitalization for Patient #1 failed to be included in the hospitalization log. The agency’s QAPI binder failed to evidence performance improvement activities for the patient hospitalizations. On 6/10/2024, at 3:22 PM, the Administrator indicated no patient hospitalizations were tracked by the agency prior to December 2023 and since January 2024 due to the Intake Coordinator being out of the office. The Administrator indicated she thought the Office Manager was tracking the hospitalizations in the absence of the Intake Coordinator but maybe not. 2. The Incident Report Summary from 9/5/2023-6/10/2024 indicated there were 5 patient falls with an average patient census of 40 equaling 13% of the patient population with a fall in Quarter 4 of 2023 and 9 patient falls with an average patient census of 37 equaling 24% of the patient population with a fall in Quarter 1 of 2024. Quarter 2 of 2024 indicated 8 additional patient falls. The agency’s QAPI binder failed to evidence performance improvement activities for the patient falls. On 6/10/2024, at 3:22 PM, the Administrator indicated she did not track every fall and indicated there were no performance improvement activities for falls. 3. The patient satisfaction survey reports for February 2023-February 2024 indicated 21% of the responses were unfavorable for the agency keeping the patients informed about the clinicians’ arrival at the patient’s home, 19% of the responses were unfavorable for the response time of the agency to provide answers or advice as needed, 22% of the responses were unfavorable for the agency talking to the patient about setting up the home for safety, 29% of the responses were unfavorable for if the agency providers talked with the patients regarding when to take medications, and 43% of the responses were unfavorable regarding the agency providers talking to the patients regarding medication side effects. On 6/10/2024, at 3:22 PM, the Administrator indicated there were no performance improvement actions for the patient satisfaction survey unfavorable responses.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, record review, and interview the agency failed to follow accepted standards of practice to prevent the transmission of infections in 2 of 2 clinical records reviewed with home visits with a registered nurse (RN). (Patient# 2, 3) Findings include: At an observation of care at the home for Patient #3 on 6/6/2024, at 11:54 AM, the Clinical Manager was not observed performing hand hygiene prior to entering the main compartment of the visit bag before removing a stethoscope, blood pressure machine/cuff, and thermometer. At 12:11 PM, the Clinical Manager was observed applying the blood pressure cuff to the pateint’s left arm and at 12:26 PM was observed placing the stethoscope on the patient’s back, chest, and abdomen. At 12:40 PM, the Clinical Manager was observed leaving the patient’s home without cleaning the stethoscope and blood pressure cuff and performing hand hygiene. On 6/7/2024, at 2:34 PM, the Administrator indicated the clinician should wash hands or apply hand sanitizer prior to entering the visit bag and before leaving the patient’s home. XX. The agency policy titled “Hand Hygiene Policy and Compliance Program”, revised 7/2021, indicates hand hygiene is recommended before and after contact with blood, body fluids, and wound dressings. The agency policy titled “Standard Precautions”, revised 4/2023, indicates manufacturers’ instructions will be followed for proper use of disinfecting products. In an observation of a home visit with Patient #2 on 6/7/24 beginning at 1:00 PM, while gloved RN 1 was providing wound care, she used gauze and saline (a mixture of salt and water) to clean dried blood from Patient’s foot. Without sanitizing hands or donning clean gloves, RN proceeded to open Puracol (a collagen dressing) and place the previously sterile dressing up against the wound and cut with scissors to fit inside wound. The cut Puracol was then placed in the wound bed of Patient’s foot. The bandage scissors used to cut the dressing were not sanitized prior to use. Throughout the wound treatment, RN did deglove and use hand sanitizer and don new gloves two times, however the hand sanitizer bottle was placed in the field touching the removed, soiled wound dressing. Once the treatment was completed, RN put the hand sanitizer into her bag without cleansing the bottle. RN then used antibacterial wipes to cleanse bandage scissors, stethoscope, blood pressure cuff, and thermometer and cleansed items were each placed directly into her bag with a dry time of less than 10 seconds each. In an interview with RN 1 during the home visit with Patient #2 on 6/7/24 starting at 1:00 PM, when asked what kind of antibacterial wipes she uses to clean her supplies, she indicated it was the purple topped wipes provided by the office staff of the agency. When asked what the dry time is of the wipes, she didn’t know. During an interview on 6/10/24 starting at 10:00 AM, Administrative staff 2 relayed the antibacterial wipes provided to staff for cleaning supplies is called Sani-wipes and offered the container. The directions for use to decontaminate indicated a 2 minute dry time for cleaning. 410 IAC 17-12-1(m) ed on observation, record review, and interview the agency failed to follow accepted standards of practice to prevent the transmission of infections in two of three clinical records reviewed with home visits (Patient# 2, 3). Findings include:”

“Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This Standard is not met as evidenced by: Based on observation, interview, and record review the agency failed to protect clinical records from loss or unauthorized use in one of one agency. Findings include: An agency policy titled “Information Confidentiality, Security, and Data Integrity”, revised March of 2018, indicated the agency will observe the patient’s right to confidentiality of information and will implement processes that assure confidentiality, security, and data integrity. An observation on 6/5/24 at 3:45 PM through 6/6/24 evidenced 8 cardboard boxes stacked in the corner of the agency office next to a locked back door. The boxes were marked discharge or DC charts with dates ranging from 2020 to 2023. The lids of the boxes were unsecure, easily opened, and contents were filled with files of patient data. The front door of the agency remained unlocked during working hours and multiple field staff and a plumber were noted in the area of the boxes. During an interview on 6/5/24 at 4:00 PM, Administrator relayed old charts are sent to a secure warehouse owned by the company and the boxes are scheduled to be picked up as soon as possible. An observation on 6/7/24 evidenced the boxes were no longer present in the office. During an interview on 6/11/24 beginning at 2:00 PM, Administrative staff 2 relayed the boxes were picked up and sent to the storage warehouse. 410 IAC 17-12-3(b)(3)”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide the name and contact information of the administrator in 1 of 2 home visits with a registered nurse. (Patient #3) The findings include: At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was reviewed with the name of Person 8 as the agency administrator. On 6/6/2024, beginning at 12:18 PM, the patient indicated they were unsure who the agency administrator was. On 6/7/2024, at 2:30 PM, the Administrator indicated Person 8 was the previous administrator that left the agency in 2023 and indicated the agency folder in the patient’s home should be updated with the current administrator’s name and contact information.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was informed about and consented to the type and frequency of care provided in advance of and during treatment in 5 of 7 records reviewed (Patient #1, 3, 4, 5, 6). The findings include: 4. A clinical record review for Patient #3 evidenced a plan of care for certification period 7/18/2023-9/15/2023, which indicated the agency was to provide physical therapy services 1 time a week for 8 weeks and skilled nursing services 1 time a week for 9 weeks. The “Admission Consent” signed and dated by the patient on 7/18/2023, failed to evidence the frequency of the physical therapy and skilled nursing services to be provided. The consent indicated the agency would provide occupational therapy (OT) services, and review failed to evidence the agency provided OT services. No additional consents were noted and no documentation the patient was notified of the visit frequency or the change in OT services to be provided. On 6/7/2024, beginning at 1:40 PM, the Administrator indicated the agency documented the patient was notified in advance and with any changes in care on the consent form and indicated the visit frequency was not completed on the form. The Administrator indicated the agency did not provide OT services and there was no other consent form. 5. A clinical record review for Patient #4 evidenced a plan of care for certification period 6/8/2024-8/6/2024 which indicated the agency would provide skilled nursing services 2 times a week. The “Admission Consent” signed and dated by the patient on 4/9/2024, failed to evidence the patient was informed prior to the change in frequency. On 6/10/2024, at 1:57 PM, the Administrator indicated there was no documentation that the patient was informed of the change in skilled nurse visit frequency to 2 times per week. On 6/11/2024, at 10:45 AM, the Administrator-in-Training indicated the correct skilled nurse visit frequency for the certification period beginning 6/8/2024 was 2 times per week. 410 IAC 17-12-3(b)(2)(D)(i)(AA) 1. A review of the admission consent for Patient #1, signed 5/15/2024, indicated the Patient was to receive skilled nursing visits once a week for 9 weeks, and a physical therapy evaluation. The plan of care for certification period 5/15/2024 to 7/13/2024 indicated the Patient was receiving skilled nursing once a week for four weeks, then one visit every other week, and physical therapy twice a week for four weeks, then once a week for 4 weeks. A clinical record review failed to evidence the patient was informed about and consented to the change in nursing visit frequency and schedule of physical therapy visits. During an interview on 6/10/2024 at 11:44 AM, the Administrator indicated the clinician should have ensured the patient consented to the change in frequency from what was on the consent, and had the Patient fill out a “change form” to acknowledge their consent, but she did not find this in the Patient’s record. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week but failed to evidence the patient was informed about and consented to the change in nursing visit frequency. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the clinician should have ensured the patient consented to the change in frequency of nurse visits and documented this, but she did not find this in the Patient’s record. 3. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 indicated physical therapy was to evaluate and treat Patient #6. A review of the Patient’s admission consent failed to evidence a frequency of physical therapy visits. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated most post-knee replacement patients get 3 PT visits a week, but the Patient agreed to 2 PT visits per week because they had a previous knee replacement and knew what to expect. During an interview on 6/11/2024 at 11:00 AM, the Patient indicated they were supposed to get 3 PT visits per week, but PT 2 changed it to twice a week. The Patient indicated they did not know why, and did not want less than 3 visits per week.”

“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 agency failed to conduct an initial assessment within 48 hours of patient referral in 3 of 5 active clinical records reviewed (Patient #2, 3, 4) and 1 of 2 closed clinical records reviewed (Patient #7). Findings include: 3. A clinical record review for Patient #3 evidenced a referral order dated 7/14/2023 for home health services. The start of care comprehensive assessment dated 7/18/2023 indicated the referral date was 7/14/2023 and failed to evidence documentation to the reason for delay in the start of care. On 6/7/2024, at 1:46 PM, the Administrator indicated she was unsure why there was a delay in the initial visit after referral and indicated there was no documentation regarding the delay. 4. A clinical record review for Patient #4 evidenced a referral document from Entity 9 dated 4/3/2024, which indicated the patient was moving back to the assisted living facility (ALF) on 4/5/2024 and would need home health services. The start of care comprehensive assessment was completed 4/9/2024 and failed to evidence the reason for the delay in the initial assessment. On 6/10/2024, at 1:23 PM, the Administrator indicated there was no documentation on the reason for the delay in the initial assessment. 5. During the entrance conference on 6/5/2024, beginning at 11:25 AM, the Administrator indicated the initial visit was completed at the time of the start of care comprehensive assessment and should be completed within 48 hours of referral. The agency policy “Initial Assessments/Comprehensive Assessments,” revised April of 2023, indicated the initial assessment is completed within 48 hours of the referral. The clinical record of Patient #2 evidenced a referral for home health care dated 01/8/24. A communication document indicated Patient was contacted and accepted home health services through the agency on 1/11/24 and initial assessment and start of care both dated 1/18/24. The clinical record of Patient #7 evidenced a communication document which indicated Patient’s home health referral was 01/29/24 and Patient requested services to have started 2/2/24. The initial assessment/start of care was completed 2/8/24. During an interview on 6/10/24 beginning at 12:15, Administrator indicated there is no documentation regarding the late initial visits for Patient #2 and Patient #7. Good 410 IAC 17-14-1(a)(1)(A)”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the comprehensive assessment failed to include the complete current health status of the patient in 4 of 7 records reviewed (Patient #1, 4, 5, 6). The findings include: 4. A clinical record review for Patient #4 evidenced the start of care comprehensive assessment dated 4/9/2024 which indicated the patient’s diagnoses included, but were not limited to, venous insufficiency (improper functioning of the veins in the legs causing swelling) and heart failure. The comprehensive assessment indicated the patient had edema (swelling) to the right leg and indicated the clinician was to report to the physician an increase in edema measurements greater than 3 centimeters. The comprehensive assessment failed to evidence measurement of the edema upon admission as a baseline on when to notify the physician with changes in edema measurement. On 6/10/2024, at 1:23 PM, the Administrator indicated there was no measurement of edema during the comprehensive assessment but should have been so changes in edema could be monitored. 410 IAC 17-14-1(a)(1)(A) 1. A review of the start of care assessment dated 5/15/2024 indicated Patient #1, who had a history of heart disease and heart failure, had pitting edema (swelling) to both legs, but failed to evidence an assessment of pulses in the feet. During an interview on 6/10/2024 at 11:28 AM, the Administrator indicated the nurse should have assessed and documented pulses in the feet for the Patient, but she did not. 2. A review of the recertification assessment dated 5/31/2024 for Patient #5 evidenced the following: the Patient had a urostomy (a surgically created opening for urine to leave the body), but failed to evidence an assessment of the urostomy site; the patient had 2+ (severity rating out of 4) edema (swelling), but failed to evidence the location of the edema; the patient had a history of compromised circulation to the legs, but failed to evidence an assessment of pulses in the feet. During an interview on 6/11/2024 at 11:54 AM, Administrative Staff 2 indicated the recertification should have included an assessment of the urostomy site, the location of the edema, and an assessment of pulses in the feet, but it did not. 3. A review of the start of care assessment dated 5/3/2024 and the discharge assessment dated 5/24/2024 indicated Patient #6 had a left knee surgical wound, but failed to evidence measurements of the wound and if a dressing was used on the wound. The assessments failed to evidence assessments of pulses in the feet. During an interview on 6/11/2024 at 1:15 PM, Administrative Staff 2 indicated the nurse should have measured the surgical wound and documented if a dressing was in use as well as assessed and documented pulses in the Patient’s feet in each assessment, but she did not.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide a comprehensive assessment that accurately reflects the patient’s status including a review of all medications and side effects in 2 of 5 active clinical records reviewed (Patients #2, 3). Findings include: The agency policy titled “Initial Assessments/Comprehensive Assessments”, revised in April of 2023, indicated a comprehensive assessment should include a review of all medications the patient is currently taking to identify side effects, interactions, and potential adverse effects. The clinical record of Patient #2 revealed a recertification comprehensive reassessment dated on 5/14/24 for the care period 5/17/24 to 7/15/24 that included a summary note which indicated Patient has an implanted Dilaudid (an opioid analgesic used for moderated to severe pain) pump for pain control. The summary indicated Patient was falling asleep with a lit cigarette in his/her hand during the medication review and RN 1 had to wake him/her. The comprehensive assessment failed to include Dilaudid in the medication profile. During an interview on 6/7/24 beginning at 2:00 PM, RN 1 indicated Patient #2 has an implanted pain medication pump and takes Lyrica (an oral pain medication) for breakthrough pain (a sudden increase in pain). 410 IAC 17-14-1(a)(1)(B) *A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin). During an observation of care at the patient’s home on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse (RN) touched the patient’s ankles and indicated the patient had a little swelling to both legs and redness to the right lower leg. At this time, the patient indicated they apply a cream to the reddened area to the right leg and provided the nurse with a cream with a prescription label indicated the patient was to apply silver sulfadiazine topically twice a day. During the visit from the Clinical Manager in its entirety from 11:54 AM to 12:40 PM, the Clinical Manager was not observed to review any other patient medications. At 12:45 PM and after the Clinical Manager left the patient’s home, the following medications were observed in the cabinet of the patient’s kitchen: acyclovir twice daily, Breo Ellipta 1 puff daily, and albuterol as needed. On 6/6/2024, at 12:45 PM, the patient indicated they took acyclovir twice a day, Breo Ellipta daily, and albuterol as needed. The progress notes from the physician responsible for the plan of care dated 5/10/2024 indicated the patient’s medications included, but were not limited to, acyclovir, albuterol, Breo Ellipta, and silver sulfadizine The undated medication profile reviewed on 6/5/2024 failed to evidence acyclovir, Breo Ellipta, albuterol, and silver sulfadiazine to include the review of the medication for potential drug interactions. Review failed to evidence any medication profile was signed and dated to indicate who reviewed the medications and when. On 6/7/2024, beginning at 2:14 PM, the Administrator indicated all the medications taken by the patient should be reviewed by looking at the medication label to ensure the medications match the medication profile. The Administrator indicated any new medications should be documented on the visit note and on the medication profile. The Administrator indicated the medication list provided by the physician must not have been reviewed to catch the acyclovir, Breo Ellipta, albuterol, and silver sulfadizine but should have been and then clarified with the patient to ensure the patient was still taking them. The Administrator indicated she was only made aware today the medication profiles were not signed and dated but should be to indicate who completed the medication review and when.”

“Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient’s primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This Element is not met as evidenced by: Based on observation, record review, and interview the agency failed to provide a comprehensive assessment that accurately reflected the patient’s status to include an assessment of the patient’s primary caregiver’s willingness, ability, and availability to provide care in 3 of 5 active clinical records reviewed. (Patient #2, 4, 5) Findings include: XX. A review of the recertification assessment dated 5/31/2024 evidenced Patient #5 lived alone and required set-up assistance to perform activities of daily living but failed to evidence the availability and schedule of patient caregivers. During an interview on 6/11/2024 at 12:38 PM, Administrative Staff 2 indicated the recertification assessment evidenced the Patient’s family member was able to assist with care, but failed to evidence the availability and schedule of the family member. XX. The agency policy “Initial Assessments/Comprehensive Assessments”, revised in April of 2023, indicated the comprehensive assessment should include the patient’s ability to function in the home and the patient’s caregiver’s willingness to provide care, availability, and schedule. An observation of a home visit of Patient #2 on 6/7/24 beginning at 1:00 PM evidenced Patient #2 residing in the basement. The caregiver/mother, noted as frail and on oxygen, was on the first level in a recliner and relayed difficulty in ‘getting around.’ The clinical record of Patient #2 evidenced a comprehensive assessment completed on 5/14/24 for the care period 5/17/24 to 7/15/24 that indicated Patient #2 has a history of falls, requires a walker to ambulate, fatigues easily, and requires assistance for most to all daily activities. Support system documentation in the comprehensive assessment included Patient’s primary caregiver was his/her mother who is willing to provide wound care and daily activity assistance. The comprehensive assessment failed to evidence an assessment of the caregiver’s ability and availability. The clinical record failed to evidence Patient was offered addition assistance nor referral or resources for assistance. During an interview on 6/11/24 starting after 2:00 PM, Patient #2 indicated his/her mother is the full-time caregiver to assist Patient with daily activities and wound care. Patient relayed the mother has a hard time caring for Patient and additional assistance is needed. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 indicated the comprehensive assessment should include a caregiver assessment and relayed it was not completed in Patient #2’s comprehensive assessment. A clinical record review for Patient #4 evidenced the start of care comprehensive assessment dated 4/9/2024 which indicated the patient required assistance with grooming, dressing, and toilet hygiene. The comprehensive assessment indicated the patient lived in an assisted living facility (ALF) and failed to evidence the assessment of what care the ALF provided regarding the patient’s need for assistance with grooming, dressing, and toilet hygiene. On 6/11/2024, at 11:40 AM, the patient indicated the ALF helped with meals and laundry and not personal care. On 6/11/2024, at 10:01 AM, RN 1 indicated the ALF did not assist the patient with ADLs and indicated she needed to address the needs of the patient with the ALF.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included all necessary components in 7 of 7 records reviewed (Patient #1, 2, 3, 4, 5, 6, 7). The findings include: XX. The clinical record for Patient #2 evidenced a plan of care for care period 5/17/24 to 7/15/24 that included a comment by RN 1 that Patient has an implanted Dilaudid (narcotic analgesic) pump for pain control. The plan of care failed to evidence Dilaudid on the medication list. Wound care documentation from Entity 6 dated 6/5/24 included orders to wear a surgical shoe when walking, increase protein intake, elevate legs above the heart for 30 minutes 3-4 times daily, to cleanse the wound with antibacterial soap, and an order for two new medications: Doxycycline (an antibiotic) and Diflucan (an antifungal). The plan of care failed to evidence the new medications and orders from the wound care clinic. XX. During an interview on 6/11/24 beginning at 11:00 AM, Other 4, son/daughter of Patient #7, relayed that Patient #7 required home oxygen. The clinical record for Patient #7 evidenced a plan of care that included durable medical equipment of an oxygen concentrator but failed to include oxygen and dosage on Patient’s medication list. 410 IAC 17-13-1(a)(1)(D)(ix) *A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024 which indicated the safety measures included bleeding precautions and the medical supplies included urinary ostomy (a surgically created hole in the bladder through the abdomen to drain urine from the body) supplies. Review of the plan of care failed to evidence the patient’s medications included a blood thinner which warranted bleeding precautions and indicated the patient’s medications included Nystatin-triamcinolone ointment to be applied topically twice daily and failed to evidence to where it was to be applied. The plan of care indicated the skilled nurse was to assess the patient’s blood sugar and report to the physician if outside of ordered parameters and assess the patient’s use of oxygen and spirometry (breathing test). The comprehensive assessment dated 5/8/2024 indicated the patient did not check blood sugar and was not on oxygen. During an observation of care in its entirety at the patient’s home on 6/6/2024 from 11:54 AM to 12:40 PM, the Clinical Manager failed to assess the patient’s blood sugar. No oxygen or spirometry use was observed by the patient. On 6/6/2024, beginning at 12:18 PM, the patient indicated they had not checked their blood sugar since February 2024 and applied the Nystatin-triamcinolone ointment to the abdominal folds. On 6/6/2024, at 12:18 PM, the Clinical Manager indicated the patient did not have a urinary ostomy and ostomy supplies should not be included in the plan of care. On 6/7/2024, beginning at 1:36 PM, the Administrator indicated there was no medication included in the medication list in the plan of care that warranted bleeding precautions and indicated the plan of care did not include to where the Nystatin-triamcinolone ointment was to be applied. The Administrator indicated the intervention on the plan of care for the nurse to assess the blood sugar was a standard order for a patient with diabetes (disease that affects the blood sugar) diagnosis but should not be included on the plan of care if it was not needed. The Administrator indicated the patient did not use oxygen and spirometry and was unsure if they could be removed from the plan of care. *A clinical record review for Patient #4 evidenced a plan of care for certification period 4/9/2024-6/7/2024 which indicated the functional limitations included prescribed exercises and failed to include the individual prescribed exercises. The plan of care indicated the agency would notify the physician of changes in the patient’s weight of 2 pounds difference in 1 day or 5 pounds difference in 1 week. The plan of care failed to be individualized to include what interventions the agency would implement to monitor the patient’s weight. On 6/10/2024, beginning at 1:16 PM, the Administrator indicated there were not patient-specific prescribed exercises included in the plan of care. The Administrator indicated there were no patient-specific interventions in the plan of care to monitor the patient’s weight such as keeping a weight log and reviewing it at every nurse visit. 1. During a home visit on 6/6/2024 at 9:20 AM, a review of the home folder evidenced a copy of Patient #1’s DNR (Do Not Resuscitate) order. A review of the plan of care for certification period 5/15/2024 to 7/13/2024 failed to evidence Patient #1 had an Advanced Directive or DNR order. A review of the patient’s clinical record evidenced a copy of the Patient’s DNR order. When informed of the findings on 6/11/2024 at 12:42 PM, Administrative Staff 2 indicated the plan of care should have evidenced the Patient had a DNR order, but it did not. 2. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 evidenced Patient #5 had a urostomy (a surgically created opening for urine to leave the body), and the nurse was to observe and assess patient / caregiver ability to manage the urostomy, but failed to evidence what the Patient’s urostomy care was. The plan of care evidenced the patient was using Mupirocin Ointment (a topical antibiotic) and Nystatin-Triamcinolone Cream (a topical anti-fungal) but failed to evidence where on the body they were used. During an interview on 6/11/2024 at 12:03 PM, Administrative Staff 2 indicated the plan of care should have included the specific care for the urostomy, including what was to be used and how frequently it should be done. Administrative Staff 2 indicated orders for topical medications should include the location on the body where they were used, but the plan of care failed to evidence the location. 3. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 evidenced the following surgical wound care orders for Patient #6: assess incision site, may cleanse with warm soapy water or saline and gauze, cover with dry gauze and tape as needed for drainage. During an interview on 6/11/2024 at 1:10 PM, Administrative Staff 2 indicated the plan of care failed to include specifically what was to be done with the surgical incision, by whom, and at what frequency.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide services only as ordered by a physician in 5 of 7 clinical records reviewed. (Patient #2, 3, 4, 6, 7) The findings include: The agency policy titled “Plan of Care – CMS #485 and Physician/Practitioner Orders”, revised 4/2023, indicated care and services provided to patient are according to physician orders which should be current and updated. XX. The clinical record for Patient #2 evidenced a start of care and initial comprehensive assessment dated on 1/18/24 for the certification period 1/18/24 to 3/7/24; the plan of care was signed by a physician on 2/15/24. The record failed to evidence a physician’s order for care prior to 2/15/24. A recertification comprehensive assessment was completed on 3/17/24 for the certification period of 3/18/24 to 5/16/24 with a physician’s signature dated 4/16/24. A 2nd recertification comprehensive assessment was completed on 5/14/24 for the certification period of 5/17/24 to 7/15/24; this plan of care failed to evidence authorization by the attending physician as of 6/11/24. During an interview on 6/11/24 beginning at 10:50 PM, RN 1 stated she has never spoken to Patient #2’s primary care physician. She indicated she has only spoken to the physician’s medical assistant and left messages therefore no physician communication was documented. XX. The clinical record for Patient #7 evidenced an initial comprehensive and start of care assessment completed on 2/8/24 for a certification period of 2/8/24 to 4/7/24. The plan of care for this care period was signed by a physician 3/4/24. The clinical record failed to evidence a physician’s order for care for nurse and physical therapy visits documents on 2/13/24, 2/22/24, and 2/29/24 nor a start of care order. During an interview on 6/11/24 beginning at 11:00 AM, Administrative staff 2 was not able to find a start of care order for Patient #7. 410 IAC 17-13-1(a) XX. A clinical record review evidenced Patient #6 received PT (Physical Therapy) services from 5/6/2024 to 5/17/2024 but failed to evidence a signed PT plan of care or PT orders. During an interview on 6/11/2024 at 1:10 PM, Administrative Staff 2 indicated the Patient’s record failed to evidence signed physician orders for PT services provided. 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which failed to evidence a physician signature. Review failed to evidence a verbal order or any other physician orders to continue home health services since the end of the previous certification period ending on 5/12/2024. On 6/10/2024, beginning at 1:07 PM, the Administrator indicated the plan of care for certification period 5/13/2024-7/11/2024 had not yet been sent to the physician for review/signature and indicated no physician order for continuation of home health services could be found since the previous plan of care, which ended on 5/12/2024. 2. A clinical record review for Patient #4, start of care 4/9/2024, evidenced an initial plan of care for certification period 4/9/2024-6/7/2024, which was not signed by the registered nurse (RN) until 5/10/2024 and not signed by the physician until 5/16/2024. The start of care comprehensive assessment completed by RN 2 and dated 4/9/2024 and the plan of care indicated the nurse left the physician a voicemail regarding the assessment and findings and clinical record review failed to evidence a start of care order for home health care services. On 6/11/2024, at 10:17 AM, RN 2 indicated the physician never returned her call and she did not receive start of care orders. On 6/10/2024, at 1:50 PM, the Administrator indicated she could not locate start of care orders for home health care services. 410 IAC 17-13-1(a)”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was reviewed by the physician at least every 60 days in 2 of 3 active clinical records reviewed with more than 1 certification period. (Patient #3, 5) The findings include: XX. A review of the plan of care for certification period 6/5/2024 to 8/3/2024 indicated Patient #5 was to receive skilled nursing visits once a week for 9 weeks. A clinical record review evidenced skilled nurse visits were scheduled once every other week. During an interview on 6/11/2024 at 11:44 AM, Administrative Staff 2 indicated the frequency of skilled nurse visits was once every other week, and the plan of care had not been revised with the new frequency of visits, but it should have been. 1. A clinical record review for Patient #3 evidenced plans of care for certification period 1/14/2024-3/13/2024 signed by the physician on 1/30/2024 and for certification period 3/14/2024-5/12/2024 signed by the physician on 4/23/2024, which was greater than 60 days. On 6/7/2024, at 2:22 PM, the Administrator indicated the physician should review the plan of care at least every 30 days and was unsure why the physician did not review the plan of care timely. 410 IAC 17-13-1(a)(2)”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to promptly alert physicians to any changes in the patient’s condition that suggest outcomes are not being achieved in 4 of 7 clinical records reviewed (Patient #2, 4, 6, and 7). Findings include: XX. The agency policy “Coordination of Patient Care”, revised 2/2021 indicates the agency should provide the physician/practitioner with patient information on an ongoing basis regarding changes in condition. The clinical record of Patient #2 evidenced a recertification assessment completed on 5/17/24 for a care period 5/17/24 to 7/15/24 with a wound assessment to Patient’s left heel. On 6/1/24, a skilled nurse visit note with RN 1 evidenced an assessment of three wounds: one to the left heel, one to the right lower leg, and to the right second toe. The comments indicated two new wound formations with plans to notify Patient’s physician on Monday, 6/3/24. The record failed to evidence physician notification of new wounds. XX. The clinical record of Patient #7 evidenced a start of care assessment completed on 2/8/24 with weekly visits from both an RN and physical therapy. Patient was discharged prior to goals being met per Patient request on 3/6/24. The record failed to evidence notification of Patient’s physician of early discharge and the cessation of services. 410 IAC 17-13-1(a)(2) XX. A physical therapy visit note dated 5/10/2025 evidenced Patient #6 had constant pain rated 8 out of 10, and that the Patient would tell the surgeon about their pain next week. A review of the Patient’s record evidenced a PT (Physical Therapy) visit was missed on 5/15/2024, and no PT visits were made on the week of 5/19/2024 to 5/25/2024, although they had been scheduled twice a week. Clinical record review failed to evidence physician notification of the Patient’s pain and the missed visits. During an interview on 6/11/2024 at 1:16 PM, Administrative Staff 2 indicated the clinical record failed to evidence physician notification of the missed visits, and the clinician should have notified the physician of the Patient’s pain. * A clinical record review for Patient #4 evidenced a referral document from Entity 9 dated 4/3/2024, which indicated the patient needed home health services to include occupational therapy (OT) services. The start of care comprehensive assessment dated 4/9/2024 indicated the patient required assistance with grooming, dressing, and toilet hygiene. Review failed to evidence the agency provided OT services and failed to evidence the agency notified the physician that OT services could not be provided. On 6/10/2024, at 1:31 PM, the Administrator indicated the agency could not provide OT services due to staffing and there was no documentation the physician was notified the agency could not provide OT services. The plan of care for certification period 4/9/2024-6/7/2024 which indicated the patient’s diagnoses included, but were not limited to, venous insufficiency (improper functioning of the veins in the legs causing swelling), and heart failure. A skilled nurse visit note dated 5/15/2024, completed by Registered Nurse (RN) 2, indicated the patient’s right leg was seeping and indicated the RN applied aquafor (skin protectant/moisturizer), covered with an ABD (a padded wound dressing to absorb wound drainage and gauze and instructed the patient to change the dressing daily. Review failed to evidence the agency notified the physician of the seeping and wound treatment. On 6/11/2024, at 9:59 AM, RN 2 indicated she left a message at the physician’s office regarding the right leg seeping and the wound treatment applied but she did not receive a return call and was unsure if the physician received the message.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the plan of care was revised to include relevant changes in 2 of 5 active clinical records reviewed. (Patient #3, 4) The findings include: 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin). During an observation of care at the home of Patient #3 on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse touched the patient’s ankles and indicated the patient had a little swelling to both legs and redness to the right lower leg. At this time, the patient indicated they applied a cream to the reddened area to the right leg and provided the nurse with a cream with a prescription label indicating the patient was to apply silver sulfadiazine topically twice a day. A clinical record review evidenced a skilled nurse visit note completed by the Clinical Manager and dated 6/6/2024 which indicated the nurse advised the patient to continue taking the silver sulfadiazine cream. Review of the plan of care for certification period 5/13/2024-7/11/2024 failed to evidence it was revised to include the silver sulfadiazine cream prior to survey exit on 6/11/2024. On 6/7/2024, at 2:21 PM, the Administrator indicated the plan of care should have been revised to reflect the new medication used by the patient but it was not. 2. A clinical record review for Patient #4 evidenced a skilled nurse visit note dated 5/15/2024 which indicated the patient’s right leg was seeping and indicated the nurse applied aquafor (skin protectant/moisturizer), covered with an ABD (a padded wound dressing to absorb wound drainage and gauze, and instructed the patient to change the dressing daily. Review failed to evidence the agency revised the plan of care for certification period 4/9/2024-6/7/2024 to include the wound treatment daily as instructed to the patient by the nurse. On 6/10/2024, at 1:47 PM, the Administrator indicated the plan of care should have been revised with the daily treatment to the right leg but it was not. The physical therapy (PT) plan of care dated 5/20/2024 indicated the patient’s PT goals included, but were not limited to, ambulating greater than 200 feet with a rolling walker, decrease pain to 1 out of 10 on a scale of 0-10 (with 10 being the worst), increase upper and lower extremity strength to 5/5, and perform safe transfers from bedroom to bathroom. The medical plan of care for certification period 4/9/2024-6/7/2024 failed to evidence the plan of care was revised to include the PT goals. On 6/10/2024, at 1:53 PM, the Administrator indicated the agency tries to revise the medical plan of care with the therapy interventions and goals if they can before it is sent to the physician, but this plan of care was not revised with the PT goals.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review and interview the agency failed to integrate all services provided directly or under arrangement to assure coordination of care provided by all disciplines in 4 of 5 active clinical records reviewed. (Patient #1, 3, 4, 5) Findings include: XX. The agency policy titled “Coordination of Patient Care”, revised 2/2021 indicates the agency must integrate all services to assure identification of patient needs and treat effectiveness. During an interview on 6/7/24 starting at 2:00 PM, Patient #2 indicated he/she visited a physician for pain every month and a wound care physician once a week and was receiving treatment from both physicians. The clinical record of Patient #2 evidenced a plan of care (POC) for care period 5/17/24 to 7/15/24 with a comment that Patient goes to a wound care clinic. The POC failed to include Entity 6 wound care clinic, the wound care physician, and Patient’s pain physician as part of the care team. The clinical record of Patient #2 evidenced wound care orders from Entity 6 on 5/31/24 and 6/7/24 with orders to wear surgical shoe when walking, increase protein intake, elevate legs above the heart for 30 minutes 3-4 times daily, and to cleanse the wound with antibacterial soap. The POC failed to include orders from the wound care physician. 410 IAC 17-12-2 (h) XX. A review of the plan of care for certification period 5/15/2024 to 7/13/2024 evidenced Patient #1 was receiving skilled nursing visits once a week for four weeks, then once every other week as well as physical therapy twice a week for four weeks, then once a week for four weeks. A review of the clinical record failed to evidence coordination of care between the nurse and physical therapist. During an interview on 6/10/2024 at 12:16 PM, the Administrator indicated the nurse and physical therapist should coordinate patient care, and document this communication in the record, but Patient #1’s record failed to evidence this care coordination. XX. A skilled nurse visit note dated 5/16/2024 evidenced Patient #5 received services at a wound clinic 3 times a week. A review of the Patient’s clinical record for certification period 4/6/2024 to 6/4/2024 failed to evidence coordination of care with the wound clinic. During an interview on 6/11/2024 at 12:10 PM, Administrative Staff 2 indicated the Patient’s clinical record failed to evidence communication with the wound clinic. *A clinical record review for Patient #3 evidenced a comprehensive assessment dated 5/8/2024 which indicated the patient lived alone and required assistance for grooming. The comprehensive assessment indicated the patient had a non-skilled caregiver 2 days a week from Entity 3 for bathing and light housekeeping. Review failed to evidence care coordination with Entity 3. At the entrance conference on 6/5/2024, at 11:25 AM, the Administrator indicated the agency would document care coordination by communicating via fax or phone with other agencies providing services to the patient and documenting the coordination in the clinical record. The Administrator indicated care coordination should take place at the start of care and at time of recertification. On 6/10/2024, at 1:13 PM, the Administrator indicated there was no care coordination with Entity 3. * A clinical record review for Patient #4 evidenced a comprehensive assessment dated 6/4/2024, completed by Registered Nurse (RN) 1, which indicated the patient lived at an assisted living facility (ALF) and had redness and cellulitis (a deep infection of the skin) to the right leg and required Minerin cream (moisturizer) to be applied daily to both legs. The comprehensive assessment indicated the patient informed the nurse they were unable to apply the cream and the ALF did not provide that type of care. Review failed to evidence the agency coordinated care with the ALF regarding the patient’s need for assistance with the application of the cream to the legs. On 6/10/2024, at 1:55 PM, the Administrator indicated the clinicians should coordinate care with the ALF after every visit and would check for any documentation of care coordination regarding the patient’s need for assistance with the cream daily. No additional documentation/information was provided before survey exit on 6/11/2024. On 6/11/2024, at 10:01 AM, RN 1 indicated she needed to check with the ALF on what they could do to help the patient apply the cream to the legs daily and had not yet done so.”

“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 and interview, the agency failed to provide the patient and caregiver with a copy of written instructions outlining the visit schedule in 3 of 3 clinical records reviewed with home visits. (Patient #1, 2, 3) Findings include: XX. During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., review of the patient’s home folder evidenced a blank calendar of visits form. During an interview on 6/6/2024 at 9:53 AM, PTA (Physical Therapy Assistant) 1 indicated they had not filled out the calendar of visits, but would call the Patient 2 to 3 days before to remind the Patient of the upcoming visit. XX. The agency policy titled “Coordination of Patient Care”, revised 2/2021, indicated the agency will coordinate care with the patient by providing a copy of written instructions that include the visit schedule. In an observation of a home visit on 6/7/24 with Patient #2 and RN 1 beginning at 1:00 PM, the agency folder at Patient’s home failed to include a visit schedule. During an interview on 6/7/24 after the home visit, Patient #2 relayed that no other paperwork was been provided by the agency including a visit schedule. *At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was observed and failed to evidence a written visit schedule since March 2024. On 6/6/2024, at 12:18 PM, the patient indicated all documents provided by the agency were kept in the agency folder and did not have any other written visit schedule. On 6/7/2024, at 2:30 PM, the Administrator indicated the visit schedule should be provided in writing to the patient by mailing it to the patient’s home.”

“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 and interview, the agency failed to provide the patient and caregiver with a copy of a writing instructions outlining the patient medication list and instructions in 3 of 3 clinical records reviewed with home visits. (Patient #1, 2, 3) Findings include: XX. During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., review of the patient’s home folder failed to evidence a current medication list. During an interview on 6/6/2024 at 10:15, Patient #1 indicated the agency did not provide them with a list of their current medications. In an interview on 6/10/2024 at 11:25 AM, the Administrator indicated the agency should mail each patient a copy of their plan of care, which includes a medication list, and document the mailing in the clinical record. The Administrator indicated Patient #1’s clinical record failed to evidence the plan of care was mailed to the Patient. The agency policy titled “Coordination of Patient Care”, revised 2/2021, indicated the agency will coordinate care with the patient by providing a copy of written instructions that include the patient’s medication list and with instructions. In an observation of a home visit on 6/7/24 with Patient #2 and RN 1 beginning at 1:00 PM, the agency folder at Patient’s home failed to include a medication list. During an interview on 6/7/24 after the home visit, Patient #2 relayed that no other paperwork was been provided by the agency including a medication list. *At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was observed and failed to evidence a written medication list since the plan of care for the certification period ending on 5/12/2024. At 12:45 PM the following medications were observed in the cabinet of the patient’s kitchen: acyclovir twice daily, Breo Ellipta 1 puff daily, and albuterol as needed. The plan of care in the patient’s home failed to include acyclovir, Breo Ellipta, and albuterol. On 6/6/2024, beginning at 12:18 PM, the patient indicated all documents provided by the agency were kept in the agency folder and indicated they took acyclovir twice a day, Breo Ellipta daily, and albuterol as needed. On 6/7/2024, at 2:30 PM, the Administrator indicated the agency should provide the medication profile as the written medication instructions and schedule and indicated the list of medications on the plan of care did not include medication instruction.”

“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 record review and interview, the agency failed to provide the patient with written information about services and treatments to be provided in 1 of 1 home visits with physical therapy observed (Patient #1) and 1 of 1 home visit observation with skilled nurse services Patient #2). The findings include: During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., review of the patient’s home folder failed to evidence a current plan of care or treatment plan. During an interview on 6/6/2024 at 10:15 AM, Patient #1 indicated they had not received a written plan of care or treatment plan from the agency. In an interview on 6/10/2024 at 11:25 AM, the Administrator indicated the agency should mail each patient a copy of their plan of care and document the mailing in the clinical record. The Administrator indicated Patient #1’s clinical record failed to evidence the plan of care was mailed to the Patient. XX. An agency policy titled “Plan of care – CMS #485 and Physician/Practitioners Orders”, revised 4/2023, indicated each patient must receive an individualized plan of care. In an observation of a home visit on 6/7/24 with Patient #2 and RN 1 beginning at 1:00 PM, the agency folder at Patient’s home failed to include a plan of care. During an interview on 6/7/24 after the home visit, Patient #2 relayed that no other paperwork was been provided by the agency including a plan of care.”

“Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the agency provided in writing to the patient the name and contact information of the case manager in 1 of 2 home visits with a registered nurse. (Patient #3) The findings include: At an observation of care at the patient’s home for Patient #3 on 6/6/2024 between 11:54 AM and 12:58 PM, the agency’s folder was reviewed and failed to evidence the name and contact information of the case manager. On 6/6/2024, beginning at 12:18 PM, the patient indicated they were unsure who their case manager was. On 6/7/2024, at 2:30 PM, the Administrator indicated the agency folder in the patient’s home should include the case manager’s name and contact information and this was how the agency provided the case manager’s contact information in writing to 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 observation, record review, and interview, the registered nurse, physical therapy assistant, and physical therapist failed to provide the services as directed in the plan of care in 5 of 7 clinical records reviewed. (Patient #2, 3, 4, 6, 7) The findings include: XX. The agency policy titled “Professional Standards of Practice”, revised 10/2017, indicates agency staff will comply with professional standards and provide care according to the plan of care. The clinical record of Patient #2 evidenced a recertification assessment completed on 5/17/24 for a care period 5/17/24 to 7/15/24 with a wound assessment to Patient’s left heel. On 6/1/24, a skilled nurse visit note with RN 1 evidenced an assessment of three wounds: one to the left heel, one to the right lower leg, and to the right second toe. The comments indicated two new wound formations with plans to notify Patient’s physician on Monday, 6/3/24. The record failed to evidence physician notification of new wounds. The clinical record for Patient #2 evidenced a start of care comprehensive assessment on 1/18/24 with a recertification comprehensive assessment completed on 3/17/24 and 5/14/24 by RN 1. The record failed to evidence orders for recertification nor the review of medications and plan for Patient care. During an interview on 6/11/24 beginning at 10:50 PM, RN 1 stated she has never spoken to Patient #2’s primary care physician. She indicated she has only spoken to the physician’s medical assistant and left messages. XX. The clinical record for Patient #7 evidenced a start of care/initial comprehensive assessment on 2/8/24 which indicated Patient had diagnoses of Atrial fibrillation (an irregular heart rhythm), hypertensive (referring to high blood pressure) heart disease with heart failure, congestive heart failure (heart muscle doesn’t pump as well as it should, may cause swelling), and diabetes mellitus type 2 (disease with high blood sugar). The plan of care was signed by a physician on 3/4/24 with no verbal orders or physician communication from 2/8/24 to 3/4/24. Skilled nursing visit note on date 2/13/24 failed to include a temperature reading with vital signs and both skilled nurse visit notes on 2/13/24 and 2/22/24 were missing Patient’s weight. The plan of care for care period 2/8/24 to 4/7/24 indicated parameters of temperature reading and an order for weight assessment every visit. During an interview on on 6/10/24 starting at 12:15 PM, Administrator indicated vital signs should be done every visit including blood pressure, heart rate, temperature, respiratory rate, and oxygen saturation. 410 IAC 17-14-1(a)(1)(H) XX. A review of the plan of care for certification period 5/3/2024 to 7/1/2024 indicated the clinician should assess Patient #6’s surgical wound at each visit. A review of the PT (Physical Therapy) evaluation dated 5/6/2024 failed to evidence an assessment of the Patient’s surgical wound. During an interview on 6/11/2024 at 11:40 AM, PT 2 indicated they should have documented what the Patient’s surgical wound looked like. 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin) and included additional diagnoses of lymphedema (tissue swelling most commonly affecting the arms and legs) and diabetes (disease affecting the body’s ability to regulate blood sugar). The patient’s medications in the plan of care included glipizide (medication used to lower blood sugar) and metformin (medication used to lower blood sugar). The plan of care indicated the skilled nurse was to provide services 1 time per week to include measure for edema (swelling) and report to the physician increases in swelling by 3 centimeters (cm) and instruct on appropriate actions to take for high/low blood sugar levels. During an observation of care at the patient’s home on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse (RN) touched the patient’s ankles and indicated the patient had a little swelling and redness. During the visit from the Clinical Manager in its entirety from 11:54 AM to 12:40 PM, the Clinical Manager was not observed to measure for edema. The comprehensive assessment completed by RN 1 dated 5/8/2024 indicated the patient had cellulitis to the right leg and had 2+ pitting edema (the grading system used to determine the severity of swelling from 0 to 4+ with 0 being no swelling and 4+ being severe) to both legs. Review failed to evidence the RN measured the edema. Skilled nurse visit notes completed by the Clinical Manager dated 5/2/2024, 5/16/2024, 5/23/2024, and 5/30/2024 indicated the patient had edema to both legs and failed to evidence the RN measured the edema. The visit notes failed to evidence the skilled nurse educated on the oral medications used to lower blood sugar levels as the box next to oral hypoglycemics (medications used to lower blood sugar levels) was left blank on the visit notes. On 6/7/2024, beginning at 2:08 PM, the Administrator indicated the nurse should follow the plan of care and indicated the measurement of the edema was not completed as ordered. The Administrator indicated the skilled nurse should have completed the visit note to include the acknowledgement of the hypoglycemic medication and teaching the appropriate actions to take for high/low blood sugar levels as directed by the plan of care. 2. A clinical record review for Patient #4 evidenced a plan of care for certification period 4/9/2024-6/7/2024 which indicated the patient’s diagnoses included, but were not limited to, pain in the right hip, lumbar spondylosis (changes in the bones and discs of the spine in the lower back), venous insufficiency (improper functioning of the veins in the legs causing swelling), and heart failure. The plan of care indicated the agency would notify the physician of pain greater than 7 on a scale of 0-10 (10 being the worst pain greater than) and the skilled nurse would assess the patient’s pain at every visit; educate the patient on non-medical pain relief measures such as applying heat/cold, repositioning, and relaxation techniques; educate the patient on pressure ulcer (wounds from prolonged pressure on the skin) prevention; notify the physician of increases in edema measurements greater than 3 cm; assess the peripheral pulse rate and strength; and notify the physician of changes in weight of 2 pounds difference in a day or 5 pounds difference in 1 week. A physical therapy note dated 4/16/2024 and completed by the physical therapy assistant (PTA) indicated the patient’s pain was 10/10 to the lower back. Review failed to evidence the PTA reported the patient’s pain to the physician. A skilled nurse visit note dated 4/17/2024 and completed by the registered nurse (RN) indicated the patient’s pain was 10/10 to the back and failed to evidence the RN notified the physician of the pain and educated the patient on non-medical pain relief measures as directed in the plan of care. The visit note indicated the patient’s skin was thin and fragile and failed to evidence the RN educated the patient on pressure ulcer prevention as directed in the plan of care. A skilled nurse visit note dated 4/24/2024 and completed by the RN failed to evidence the RN assessed the patient’s pain and indicated the patient’s skin was thin and fragile. The visit note failed to evidence the RN educated the patient on non-medical pain relief measures and pressure ulcer development as directed in the plan of care. A skilled nurse visit note dated 4/29/2024 and completed by the RN indicated the patient’s skin was thin and fragile and failed to evidence the RN educated the patient on pressure ulcer development as directed in the plan of care. The skilled nurse visit notes for certification period 4/9/2024-6/7/22042 failed to evidence the skilled nurse assessed the patient’s weight and measured the edema to be able to notify the physician of weight and edema measurement changes as ordered in the plan of care. The visit notes failed to evidence the skilled nurse assessed the peripheral pulse rate and strength as ordered in the plan of care. On 6/10/2024, beginning at 1:38 PM, the Administrator indicated there was no documentation the PTA and RN communicated the 10/10 pain to the physician and did not see the skilled nurse educated the patient on non-medical pain relief. The Administrator indicated she did not see the nurse assessed the peripheral pulses and indicated the pain assessment was blank on note dated 4/24/2024. The Administrator indicated the nurse should have educated the patient on pressure ulcer prevention but did not see that it was done. 410 IAC 17-14-1(a)(1)(H)”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on observation, record review, and interview, the skilled nurse failed to prepare clinical notes accurately and/or timely in 1 of 2 home visits with a registered nurse (RN) (Patient #3) and in 1 of 2 active clinical records reviewed with physical therapy (PT) services (Patient #4). The findings include: 1. A clinical record review for Patient #3 evidenced a plan of care for certification period 5/13/2024-7/11/2024, which indicated the primary diagnosis was cellulitis (a deep infection of the skin). During an observation of care at the patient’s home on 6/5/2024, at 12:15 PM, swelling to both legs and feet were observed, at which time the Clinical Manager/Registered Nurse (RN) touched the patient’s ankles and indicated the patient had a little swelling to both legs and redness to the right lower leg. At this time, the patient indicated they apply a cream to the reddened area to the right leg and provided the nurse with a cream with a prescription label indicated the patient was to apply silver sulfadiazine (antibiotic cream) topically twice a day. During the visit from the Clinical Manager in its entirety from 11:54 AM to 12:40 PM, the Clinical Manager was not observed to review any other patient medications nor was the Clinical Manager observed asking the patient if there were any additional medications that were not listed. At 12:45 PM and after the Clinical Manager left the patient’s home, the following medications were observed in the cabinet of the patient’s kitchen: acyclovir (medication used to treat viral infections) twice daily, Breo Ellipta 1 puff daily (medication to relax the airway to assist breathing), and albuterol (medication used to treat shortness of breath) as needed. On 6/6/2024, at 12:45 PM, the patient indicated they took acyclovir twice a day, Breo Ellipta daily, and albuterol as needed. The undated medication profile reviewed on 6/5/2024 failed to evidence acyclovir, Breo Ellipta, albuterol, and silver sulfadiazine. On 6/10/2024, the medication profile failed to be revised to include the acyclovir, Breo Ellipta, and albuterol. The skilled nurse visit note completed by the Clinical Manager for visit date 6/6/2024 indicated the nurse reviewed and updated the medication list and indicated the medications were unchanged. The nurse failed to prepare the clinical note accurately regarding the failure to review the medication list to ensure all the medications taken by the patient were reviewed and the medication list updated. On 6/11/2024, at 10:45 AM, the Administrator-in-Training indicated the nurse should not have marked the medication list was reviewed if the nurse did not go over each medication to ensure the patient was still taking them and asking about any additional medications. 2. A clinical record review for Patient #4 indicated PT was scheduled on 5/15/2024 for a reassessment but failed to evidence the documentation of the reassessment. On 6/11/2024, at 11:30 AM, the Administrator-in-Training indicated PT 2 completed the reassessment on 5/15/2024 but was having tablet issues and had not yet submitted the documentation of the reassessment. 410 IAC 17-14-1(a)(1)(E) 410 IAC 17-14-1(c)(5)”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided in accordance with current clinical practice guidelines and professional standards of practice in 2 of 7 records reviewed (Patient #1, 5). The findings include: 1. A review of the American Physical Therapy Association (APTA) website, https://www.apta.org/, physical therapists should take vital signs (heart rate, blood pressure, respiratory rate, temperature, and pulse oximetry) of patients because they provide important information about a patient’s cardiovascular and pulmonary systems, as well as their baseline wellness and response to physical activity, environmental conditions, and emotional stressors. 2. A review of the physical therapy evaluation dated 5/18/2024 for Patient #1, who had an acute rib fracture, heart failure, and frequent shortness of breath, failed to evidence a respiratory rate or pulse oximetry reading. During an interview on 6/10/2024 at 12:09 PM, the Administrator indicated the physical therapist should have assessed and documented the Patient’s respiratory rate and pulse oximetry in their evaluation, but they did not. 3. A review of a skilled nurse visit note dated 6/6/2024 indicated Patient #5, who had a history of compromised circulation to the legs, had 1+ (severity rating out of 4) edema (swelling) to both legs but failed to evidence an assessment of pulses in the feet. During an interview on 6/11/2024 at 11:54 AM, Administrative Staff 2 indicated the nurse should have assessed and documented the pulses in the Patient’s feet at each visit, but they did not.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient record included all physician orders in 3 of 7 records reviewed (Patient #1, 2, 6). The findings include: XX. The agency policy titled “Plan of Care – CMS #485 and Physician/Practitioner Orders”, revised 4/2023, indicated care and services provided to patient are according to physician orders which should be current and updated. The clinical record of Patient #2 evidenced wound care orders from Entity 6 on 5/31/24 and 6/5/24 with orders to wear surgical shoe when walking, increase protein intake, elevate legs above the heart for 30 minutes 3-4 times daily, and to cleanse the wound with antibacterial soap. The wound care order from 6/5/24 included an order for two new medications: Doxycycline (an antibiotic) and Diflucan (an antifungal). The clinical record failed to include any orders from the wound care physician. During an interview with on 6/7/24 beginning at 2:00 PM, RN 1 relayed she has not reviewed the wound care orders and had planned on going to the agency to request a copy of them. 1. A review of the plan of care for certification period 5/15/2024 to 7/13/2024 evidenced Patient #1 was taking Ciprofloxacin (an antibiotic) every 12 hours. During observation of a home visit for Patient #1 on 6/6/2024 at 9:20 a.m., a review of the patient’s home medications failed to evidence Ciprofloxacin. During an interview on 6/6/2024 at 10:15 AM, the Patient indicated they were no longer taking Ciprofloxacin. During an interview on 6/10/2024 at 11:25 AM, the Administrator indicated the nurse should have documented an order to discontinue the Ciprofloxacin, but she did not find one in the Patient’s record. 2. A clinical record review indicated physical therapy was to evaluate and treat Patient #6 for post-knee replacement care. The nurse performed the start of care visit on 5/3/2024, and the PT (Physical Therapy) evaluation was done on 5/6/2024. The Patient was scheduled for 2 PT visits per week. A clinical record review evidenced one PT visit was performed on the week of 5/12/2024 to 5/18/2024 and failed to evidence any PT visits were performed the following week. The clinical record failed to evidence why the start of physical therapy was delayed and why no PT visits were completed from 5/17/2024 until the skilled nurse discharged the Patient on 5/24/2024. During an interview on 6/11/2024 at 11:40 AM, PT (Physical Therapist) 2 indicated they did not know why there was a delay in starting therapy for the Patient. During an interview on 6/11/2024 at 1:21 PM, Administrative Staff 2 indicated the initial PT evaluation should have been done within 48 hours of the admission, or there should be documentation explaining the delay, but the Patient’s record failed to evidence such documentation. Administrative Staff 2 indicated the record should have included communication notes to explain the missed visits, but it did not.”