Every finding on record at Beaumont Ashn, LLC

An unannounced standard Emergency Preparedness survey was conducted on 9/23/25 through 9/26/25 by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Beaumont Home Health was found to be in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness.

An unannounced Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 9/23/25 to 9/26/25 at: Beaumont Home Health 1975 Technology Drive, Suite #J120 Troy, MI 48083 This agency does not operate any branch offices. Records reviewed: 17 (7 records with home visits, 5 active records without home visits, and 5 discharged records) At the conclusion of the survey, the agency was found to be in substantial compliance with the conditions of participation for 42 CFR Part 484, Home Health.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient received all services outlined in the plan of care for 2 (P-2 and P-16) of 17 records reviewed, resulting in the potential for unmet care needs. Findings include: Patient #16: (P-16)'s SOC was 4/14/25, with diagnoses of diabetes type 2, gastroparesis, and pancreatitis. The Plan of Care ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Medical Social Worker services. During record review on 9/24/25, it was discovered that medical social worker (MSW) services were ordered to start on 4/17/25. There were no documented MSW visits in the record. During an interview on 9/26/25 at 1:30 PM, the administrator (Adm-1) acknowledged the above findings and stated, "The MSW was never notified that services were ordered." Patient #2 (P-2) was admitted to this home care agency on 7/2/25 with the diagnosis of hypertension (high blood pressure). During record review on 9/24/25, it was determined the plan of care (dated 7/2/25) ordered social work services 2 times a week for 4 weeks and home health aide services 2 times a week for 4 weeks. Upon further review of the record, it was determined P-2 was never seen by the social worker or the home health aide between 7/2/25 and 8/27/25 when the patient was receiving home health care from this agency. During review of the orders written for P-2, it was noted there were orders written on 7/7/25, 7/15/25, and 7/28/25 to move the social work evaluation due to “inability to coordinate care.” An order was written on 8/8/25 to void social work services due to “inability to coordinate care.” Additionally, review of home health aide documentation revealed 9 missed visits were documented for various reasons. No home health visits were actually made by the home health aide. The agency failed to ensure the patient received all services outlined in the plan of care. The administrator (Adm-1), regional vice president (RVP), and director of survey accreditation and support service (DSA) reviewed and acknowledged the findings during an interview on 9/26/25 at 8:35 AM.

Document efforts to resolve problems CFR(s): 484.50(d)(5)(iv) (iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that 1 (Patient/P-6) of 4 patients reviewed with severe pain levels had an appropriate documented response in addressing the pain, from a total of 17 sampled patients resulting in unidentified health concerns, delay in treatment and unmet patient care needs. Findings include: P-6: The patient's start of care (SOC) to the home care agency was 8/22/25, with diagnoses that included post-surgical laminectomy with discectomy, spinal stenosis, and hypertension. On 9/24/25, record review of the SOC comprehensive assessment performed by skilled nursing (SN) on 8/22/25, noted P-6's pain level was "Excruciating" or a 9 out of 10 (10 being the worst possible), affecting P-6's back and legs. The "Provider (physician) Notification" section within the SOC assessment was left blank. Further, no documentation was found that SN had attempted any pain-relieving measures that could provide relief or potentially resolve P-6's pain at the time. The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings listed above in an interview on 9/26/25 at 11:22 AM. Administration above further acknowledged this did not meet agency expectations or its policy referenced below. Agency Policy: "Pain Assessment" ID: QA-014 HH (revised 9/21/22) stated, "All patients will receive an initial pain assessment. When pain is identified, a more comprehensive pain assessment will be completed. Pain assessments ...will be documented to facilitate regular reassessment and follow-up by clinicians." The agency failed to document any follow-up actions/interventions to help resolve/lesson P-6's "excruciating" pain experienced during the SOC assessment.

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 record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects, and failed to provided documented evidence that the physician was notified of identified drug interactions in 10 (Patient/P-6, P-9, P-10, P-11, P-12, P-13, P-14, P-15, P-16, P-17) of 17 records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: Patient #14: (P-14)'s Start of Care (SOC) was 9/20/25, with diagnoses of fracture of vertebrae, hypertension and falls. The Plan of Care ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Home Health Aide services. During record review on 9/24/25, it was discovered that section M2001 (Medication review) of the Initial Comprehensive Assessment documented "No issues found during review." The patient's medications were reviewed on 9/24/25, in the agency's electronic medical record and revealed 3 moderate drug-to-drug interactions. Patient #15: (P-15)'s SOC was 9/6/25, with diagnoses of Left femur fracture, falls, and pain. The Plan of Care ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Home Health Aide services. During record review on 9/25/25, it was discovered that section M2001 (Medication review) of the Initial Comprehensive Assessment documented "No issues found during review." The patient's medications were reviewed on 9/25/25, in the agency's electronic medical record and revealed 4 moderate drug-to-drug interactions. Patient #16: (P-16)'s SOC was 4/14/25, with diagnoses of diabetes type 2, gastroparesis, and pancreatitis. The Plan of Care ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Medical Social Worker services. During record review on 9/24/25, it was discovered that section M2001 (Medication review) of the Initial Comprehensive Assessment documented "No issues found during review." The patient's medications were reviewed on 9/24/25, in the agency's electronic medical record and revealed 11 moderate and 4 severe drug-to-drug interactions. The agency also failed to include oxygen on the medication profile. P-16 was on 3L of oxygen via nasal cannula. Patient #17: (P-17)'s SOC was 9/21/25, with diagnoses of diabetes type 2, joint replacement aftercare, and pain. The Plan of Care ordered Skilled Nursing and Physical Therapy services. During record review on 9/23/25, it was discovered that section M2001 (Medication review) of the Initial Comprehensive Assessment documented "No issues found during review." The patient's medications were reviewed on 9/23/25, in the agency's electronic medical record and revealed 2 moderate drug-to-drug interactions. The administrator (Adm-1) reviewed and confirmed the above findings during an interview on 9/26/25 at 1:30 p.m. Patient #9’s (P-9) Start of Care (SOC) was dated 6/25/25. The Plan of Care (POC) identified diagnoses of Knee Replacement, Hypertension and Anemia. During record review on 9/25/25, it was noted that one “Medication Interaction” note was completed on 6/25/25 that stated, “MD (Medical Doctor) office notified.” The comprehensive assessment dated 6/25/25 stated, “Provider Notification: The provider below was contacted to report the following: Blank.” The medical record contains conflicting evidence of whether the physician was indeed contacted to report the medication interaction. Additionally, the med profile documented three medications, Hydrocodone, Naloxone and Nitroglycerin as “As Needed” frequency. There were no instructions as to the ordered frequency. Patient #10’s (P-10) Start of Care (SOC) was dated 7/16/25. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Atrial Fibrillation and Vascular Disorder of Intestine. During record review on 9/23/25, it was noted that the Registered Nurse completed an evaluation assessment on 7/24/25 and documented, “Respiratory: Indicate the oxygen flow rate: 2 LPM (Liters per minute). Frequency of oxygen: Continuous.” The medication profile updated on 7/24/25 failed to include Oxygen. Patient #11’s (P-11) Start of Care (SOC) was dated 9/20/25. The Plan of Care (POC) identified diagnoses of Post Laminectomy, Obesity and Hypertension. During record review on 9/24/25, it was noted that two “Medication Interaction” notes were completed on 9/20/25 that stated, “DR (Doctor) aware.” The comprehensive assessment dated 9/20/25 stated, “Provider Notification: The provider below was contacted to report the following: Blank.” The medical record contains conflicting evidence of whether the physician was indeed contacted to report the medication interactions. Additionally, the Electronic Medical Record (EMR) documented discrepancies from the Referral and medication profile. The missing medications from the referral were Aspirin, Acetaminophen, Senna, Ergocalciferol, Furosemide and Rosuvastatin. There is no documented medication reconciliation completed with the physician to determine an accurate home medication regimen. Patient #12’s (P-12) Start of Care (SOC) was dated 7/12/25. The Plan of Care (POC) identified diagnoses of Colon Cancer, Anemia, Ileostomy. During record review on 9/24/25, it was noted that five “Medication Interaction” notes were completed on 7/12/25 that stated, “MD (Medical Doctor) order.” The comprehensive assessment dated 7/12/25 stated, “Provider Notification: The provider below was contacted to report the following: Blank.” The medical record contains conflicting evidence of whether the physician was indeed contacted to report the medication interactions. Patient #13’s (P-13) Start of Care (SOC) was dated 6/26/25. The Plan of Care (POC) identified diagnoses of Hypocalcemia, Hypokalemia and Hypomagnesemia. During record review on 9/25/25, it was noted that nine “Medication Interaction” notes were completed on 6/26/25 that stated, “Physician aware.” The comprehensive assessment dated 6/26/25 stated, “Provider Notification: The provider below was contacted to report the following: Blank.” The medical record contains conflicting evidence of whether the physician was indeed contacted to report the medication interactions. A review of the agency policy occurred on 9/26/25 titled "Medication Profile" (Reviewed: 9/7/202). The policy states, "Purpose: To define the use of the medication profile in evaluating a patient’s current medication regimen…Policy: Patients receiving medications will have a current, accurate medication profile in the clinical record…3.3 Medication Interaction 3.3.2 All interactions require physician notification via a phone call and documentation in PointCare. 3.3.3 A higher severity interaction (2 or 3), should include a request of urgency when leaving a message for the physician.” The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings listed above in an interview on 9/26/25 at 9:45 am. P-5: This patient was admitted to the home care agency on 9/17/25, with diagnoses that included after care following right total knee replacement, diabetes-type 2, and chronic pain. During a joint home visit with physical therapy services on 9/23/25, the hospital discharge medication list for P-5 was compared to the medication list generated by home care's skilled nursing (SN), which populated onto P-5's plan of care (POC) on 9/17/25. During this review, the following medication discrepancies were found: The POC listed a total of 7 medications but failed to include medications that P-5 needed to take after hospital discharge on 9/16/25, which were: Aspirin 81 mg. twice a day; Voltaren (pain/inflammation relieving 1% gel to skin twice a day); Colace (stool softener) twice a day as needed; Norco 5-325 mg. 1-2 tablets every 6 hours as needed for pain relief; Zofran 1 tablet every 8 hours as needed for nausea/vomiting; and Ultram 1 tablet every 6 hours as needed for pain relief. The comprehensive assessment performed by SN, documented under "Medications" that "No issues were found during review." Physician notification was not evidenced in the medical record concerning the medication discrepancies noted above which go against the agency's policy titled "Medication Profile". This policy stipulates all interactions require physician notification and a higher severity interaction (2 or 3), "should include a request of urgency when leaving a message for the physician." No evidence was found indicating this was done, which included all the medications that P-5 was taking on 9/17/25. The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the above findings during an interview on 9/26/25 at 10:56 AM.

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 attempt to reschedule missed visits to meet the frequency in the plan of care in 2 (P-2 and P-4) of 17 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: Patient #2 (P-2) was admitted to this home care agency on 7/2/25 with the diagnosis of hypertension (high blood pressure). During record review on 9/24/25, it was noted the plan of care (dated 7/2/25) ordered services from a home health aide 2 times a week for 4 weeks. Upon further review of the record, it was determined 9 of 9 scheduled home health aide visits were documented as missed visits for various reasons. However, there was no documentation of attempts made to reschedule the missed visits to meet the ordered visit frequency. Patient #4 (P-4) was admitted to this home care agency on 8/9/25 with the diagnoses of bilateral radius and ulna (wrist) fractures, hemiplegia following a cerebrovascular accident (weakness on half of the body following a stroke), and type II diabetes mellitus. During record review on 9/25/25, it was noted that skilled nursing services were ordered 1 time a week for 9 weeks and home health aide services were ordered 1 time a week for 2 weeks, 2 times a week for 1 week, and 1 time a week for 4 weeks. During review of the visit notes, it was determined that skilled nursing was unable to reach the patient on 9/3/25 for a visit and no visit was made that week. A missed visit was documented, however, there was no documentation of attempts made to reschedule the missed visits to meet the ordered visit frequency. Additionally, it was noted the home health aide documented a missed visit on 9/19/25 due to no answer at the door. However, there was no documentation of who was notified of the missed visit or of attempts made to reschedule the missed visit to meet the ordered frequency. A review of agency policy titled “Missed Visit Management” (last reviewed 9/20/22) revealed, “A missed visit is one in which all efforts have been exhausted to reschedule the patient under the current ordered frequency.” The administrator (Adm-1), regional vice president (RVP), and director of survey accreditation and support service (DSA) reviewed and acknowledged the findings during an interview on 9/26/25 at 8:35 AM.

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 patient specific parameters to meet the needs of the patient for 10 (P-1, P-2, P-3, P-4, P-6, P-9, P-14, P-15, P-16 and P-17) of 17 records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: Patient #14: (P-14)'s Start of Care (SOC) was 9/20/25, with diagnoses of fracture of vertebrae, hypertension and falls. The Plan of Care (POC) ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Home Health Aide services. During record review on 9/24/25, it was discovered that the POC failed to include pain parameters to notify the physician with P-14 having a diagnosis of fracture of vertebrae. Patient #15: (P-15)'s SOC was 9/6/25, with diagnoses of Left femur fracture, falls, and pain. The Plan of Care ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Home Health Aide services. During record review on 9/25/25, it was discovered that the POC failed to include pain parameters to notify the physician with P-15 having a diagnosis of femur fracture and pain. Patient #16: (P-16)'s SOC was 4/14/25, with diagnoses of diabetes type 2, gastroparesis, and pancreatitis. The Plan of Care ordered Skilled Nursing, Physical Therapy, Occupational Therapy, and Medical Social Worker services. During record review on 9/24/25, it was discovered that no blood sugar parameters were ordered on the POC with a primary diagnosis of type 2 diabetes mellitus. Patient #17: (P-17)'s SOC was 9/21/25, with diagnoses of diabetes type 2, joint replacement aftercare, and pain. The Plan of Care ordered Skilled Nursing and Physical Therapy services. During record review on 9/23/25, it was discovered that the POC failed to include pain parameters to notify the physician with P-17 having a diagnosis of joint replacement, and pain. The POC also failed to include blood sugar parameters with a diagnosis of diabetes mellitus. The administrator (Adm-1) reviewed and confirmed the above findings during an interview on 9/26/25 at 1:30 p.m. Patient #9’s (P-9) Start of Care (SOC) was dated 6/25/25. The Plan of Care (POC) identified diagnoses of Knee Replacement, Hypertension and Anemia. During record review on 9/25/25, it was noted that the POC stated, “Physical Therapist to monitor and provide instruction regarding pain control methodologies including pharmacologic and non-pharmacologic methods. Therapist will notify client’s physician, RN (Registered Nurse) case manager or a clinical liaison of uncontrolled pain…” The Physical Therapy Assistant (PTA) completed a visit on 6/27/25 and stated, “Pain: Indicate client’s level of pain: Standardized pain assessment: Excruciating (9-10) (Intervention required)…” The coordination note dated 6/27/25 stated, “Assessment: Patient reports 9/10 pain in L (Left) knee. Educated painted on pain management techniques including rest, ice, positioning, taking pain medication prior to arrival…” The POC failed to contain pain parameters to notify the physician. A review of the agency policy occurred on 9/26/25 titled "Ongoing Assessment" (Reviewed: 9/2/2022) The policy states, "1. During each home visit, plan of care review or comprehensive assessment, the appropriate clinician with support of clinical leadership if necessary, will re-evaluate the patient’s status according to the problems identified during the episode. 2. Using the standards of care identified by the organization and in collaboration with the patient/representative, the clinician will reassess the patient for: 2.3. Pain status when applicable.” The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings listed above in an interview on 9/26/25 at 9:55 am. P-6: The patient's start of care (SOC) to the home care agency was 8/22/25, with diagnoses that included post-surgical laminectomy with discectomy, spinal stenosis, and hypertension. On 9/24/25, record review of P-6's Plan of Care (POC) effective on 8/22/25, documented the following: "Skilled Nurse (SN) to intervene with increased pain level to minimize complications." The POC failed to provide clear guidance of when to notify the physician for potential orders, including when a patient meets or exceeds severe pain thresholds. This was evident on 8/22/25, when the SOC comprehensive assessment performed by SN, documented P-6's pain level was "Excruciating" or a 9 out of 10 (10 being the worst possible). Since the POC did not specific interventions or pain parameters to notify the physician, P-6 had no documented clinical support by SN when experiencing excruciating pain on 8/22/25. The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings listed above in an interview on 9/26/25 at 11:22 AM. Administration above further acknowledged this did not meet agency expectations or its policy referenced below. Patient #1 (P-1) was admitted to this home care agency on 9/2/25 with the diagnoses of spinal stenosis status post lumbar laminectomy with posterior spinal fusion (lower back surgery with hardware placement). During record review on 9/23/25, it was noted the start of care assessment performed by the physical therapist on 9/2/25 indicated P-1 had pain that was “Horrible (7-8) (Intervention Required).” Upon further review of the record, it was determined the plan of care failed to include pain parameters for when to notify the physician. Patient #2 (P-2) was admitted to this home care agency on 7/2/25 with the diagnosis of hypertension (high blood pressure). During record review on 9/24/25, it was noted the start of care assessment performed by the skilled nurse on 7/2/25 indicated P-2 had pain that was “Discomforting (3-4).” Upon further review of the record, it was determined the plan of care failed to include pain parameters for when to notify the physician. Patient #3 (P-3) was admitted to this home care agency on 8/15/25 with diagnoses of a thoracic aorta aneurysm and chronic kidney disease. During record review on 9/24/25, it was noted the start of care performed by the skilled nurse on 8/15/25 indicated P-3 had pain that was “Distressing (5-6) (Intervention Required).” Upon further review of the record, it was determined the plan of care failed to include pain parameters for when to notify the physician. Patient #4 (P-4) was admitted to this home care agency on 8/9/25 with the diagnoses of bilateral radius and ulna (wrist) fractures, hemiplegia following a cerebrovascular accident (weakness on half of the body after a stroke), and type II diabetes mellitus. During record review on 9/25/25, it was noted the start of care performed by the skilled nurse on 8/9/25 indicated P-4 had pain that was “Discomforting (3-4).” Upon further review of the record, it was determined the plan of care failed to include pain parameters for when to notify the physician. The administrator (Adm-1), regional vice president (RVP), and director of survey accreditation and support service (DSA) reviewed and acknowledged the findings during an interview on 9/26/25 at 8:35 AM.

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 ensure communication to integrate all services to ensure patient needs were met in 1 (P-2) of 17 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs Findings include: Patient #2 (P-2) was admitted to this home care agency on 7/2/25 with the diagnosis of hypertension (high blood pressure). During record review on 9/24/25, it was noted the plan of care (dated 7/2/25) ordered services from skilled nursing 1 time a week for 3 weeks and once every other week for 6 weeks, physical therapy 1 time a week for 6 weeks, occupational therapy 1 time a week for 7 weeks, home health aide services 2 times a week for 4 weeks, and social work for 2 times a week for 4 weeks. Upon further review of the record, it was determined there were no visits made by social work or a home health aide. Upon review of the orders, it was noted there were orders dated 7/7/25, 7/15/25 and 7/28/25 to move the social work evaluation due to “inability to coordinate care." Ultimately, the order for social work was voided on 8/8/25 due to continued “inability to coordinate care.” There was no documentation to indicate the social worker attempted to coordinate care with skilled nursing (who completed 5 of 5 scheduled visits), physical therapy (who completed 5 of 8 scheduled visits), or occupational therapy (who completed 5 of 7 scheduled visits) during the time P-2 was receiving services from this agency. Upon review of the missed visits documented by the home health aide, it was determined the 9 of 9 scheduled visits were missed for various reasons. There was no documentation to indicate the home health aide attempted to coordinate care with skilled nursing, physical therapy, or occupational therapy as mentioned above. A review of agency policy titled “Coordination of Services” (last reviewed 9/7/22) revealed, “5. When the patient requires more than one (1) service from the organization, the agency is responsible for coordinating care planning in order to assure that goals, actions, and the interrelationship of services are not duplicated and to minimize the potential for missed or conflicting services.” There was no evidence of care coordination between disciplines to meet identified patient needs. The administrator (Adm-1), regional vice president (RVP), and director of survey accreditation and support service (DSA) reviewed and acknowledged the findings during an interview on 9/26/25 at 8:35 AM.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency's skilled nursing (SN) services failed to coordinate and facilitate care as ordered by the physician in 1 (Patient/P-7) of 2 records reviewed with congestive heart failure, from a total sample of 17 records reviewed, resulting in the lack of cardiac monitoring and the potential for poor clinical outcomes. Findings include: P-7: The patient's start of care (SOC) was 4/6/25, with diagnoses that included hypertensive heart disease, congestive heart failure (CHF), and chronic respiratory failure with hypoxia. On 9/24/25, record review of the referral for home care effective 4/5/25 noted P-7 was discharged from the hospital due to exacerbation (worsening) of CHF fluid overload. Hospital discharge records noted daily weights were warranted to monitor for the reoccurrence of fluid overload and subsequent hospital re-admission. The plan of care ordered the skilled services of nursing (SN): 2W1 (twice weekly visits times one week), followed by 1W8, physical therapy (PT: 1W8), and occupational therapy (OT: 1W9). The SOC assessment performed by SN on 4/6/25 documented P-7's weight was 360 pounds. On 4/10/25, SN documented a weight of 360 pounds again. However, the day after on 4/11/25, PT services performed their evaluation and agency records noted P-7's weight had increased to 373 pounds. Follow-up visits were made by SN and OT services on 4/17/25 with a recorded weight of 373 pounds. Up to this point, no documentation was found in the medical record that indicated any of the skilled disciplines assigned were aware of the significant weight increase potentially caused by fluid overload. On 4/24/25, SN and OT services again provided home visits and the recorded weight on that day had another increase to 380 pounds. No physician notification or coordination of care was found in the record concerning this SCIC (significant change in condition). Subsequent visits were provided by all 3 services through 5/6/25 with the last recorded weight being 380 pounds. The next day (5/7/25), P-7's weight had decreased to 366 pounds with no further increases noted. The findings above were reviewed and acknowledged by the Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) during an interview on 9/26/25 at 12:13 PM. All further acknowledged this did not meet agency expectations or its policy referenced below. Agency Policy: "Coordination of Services" ID: OP-009 HH (revised 9/7/22) stated, "Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and abilities of the patient...The clinician/technician will be responsible for facilitating communications about changes in the patient's status among the assigned personnel."

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 patients were provided with the name and contact information of the clinical manager in 1 (P-1) of 7 records reviewed, resulting in the potential for patients to be unaware of who to contact regarding concerns about the agency. Findings include: The agency’s admission booklet given to patients was reviewed on 9/23/25 at 11:30 AM. During review of the booklet, it was noted it included contact information for a clinical manager, however, the name of the clinical manager was not identified. Upon further review of the admission packet, it was noted the first page had a blank line next to the words “Clinical Manger” as well as blank spaces next to other disciplines to be filled out. During a joint home visit with Patient #1 (P-1) and the occupational therapist on 9/24/25 at 9:00 AM, it was noted there was no name listed next to the space for clinical manager in P-1's admission booklet. During an interview with the administrator (Adm-1) on 9/25/25 at 1:49 PM, Adm-1 was queried regarding the above findings. Adm-1 stated the agency has 8 clinical managers and the staff should be writing the name of the clinical manager for each patient in the front of the booklet upon admission. Adm-1 acknowledged the findings at the time of interview.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the professional staff provided ongoing reassessment in 7 (P-1, P-2, P-4, P-9, P-10, P-14, P-16) of 17 records, resulting in the potential for unidentified patient needs. Findings include: Patient #14: (P-14)'s Start of Care (SOC) was 9/20/25, with diagnoses of fracture of vertebrae, hypertension and falls. The Plan of Care ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), and Home Health Aide (HHA) services. During record review on 9/25/25, it was discovered that the plan of care (POC) had oxygen saturations (O2 Saturation) ordered for each visit. SN failed to document an O2 saturation on 9/20/25, and OT failed to document an O2 saturation on 9/23/25. Patient #16: (P-16)'s SOC was 4/14/25, with diagnoses of diabetes type 2, gastroparesis, and pancreatitis. The Plan of Care ordered SN, PT, OT, and Medical Social Worker (MSW) services. During record review on 9/24/25, it was discovered that the plan of care (POC) had oxygen saturations (O2 Saturation) ordered for each visit. SN failed to document an O2 saturation on 4/14/25, OT failed to document an O2 saturation on 4/25/25, and PT failed to document O2 saturations for 4/16/25, 5/13/25, and 5/19/25. The administrator (Adm-1) reviewed and confirmed the above findings during an interview on 9/26/25 at 1:30 p.m. Patient #9’s (P-9) Start of Care (SOC) was dated 6/25/25. The Plan of Care (POC) identified diagnoses of Knee Replacement, Hypertension and Anemia. During record review on 9/25/25, it was noted that the Physical Therapist (PT) completed a comprehensive assessment on 6/25/25 with an ordered frequency of 2w2 (2 times a week for 2 weeks), 3w1. The POC stated, “Orders of Discipline and Treatments: …Therapist will perform temperature, blood pressure, oxygen saturation level, respiratory rate and heart rate at each visit.” The PT failed to document oxygen saturation level for 7 of 7 completed visits. Patient #10’s (P-10) Start of Care (SOC) was dated 7/16/25. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Atrial Fibrillation and Vascular Disorder of Intestine. During record review on 9/23/25, it was noted that the PT completed a comprehensive assessment on 7/16/25 with an ordered frequency of 1w8. The POC stated, “Orders of Discipline and Treatments: …Therapist will perform…oxygen saturation level…at each visit.” The PT failed to document oxygen saturation level for 8 of 8 completed visits. Additionally, the Occupational Therapist (OT) completed an evaluation on 7/17/25 with an ordered frequency of 1w2, 1q2w2 (1 time every two weeks for 2 weeks), 1w4. The OT POC stated, “…Occupational Therapist…Therapist will perform…oxygen saturation level…at each visit.” The OT failed to document oxygen saturation level for 3 of 6 completed visits: 7/17/25 (OT evaluation), 8/14/25 and 9/5/25 (OT discharge). Furthermore, Skilled Nursing (SN) completed an evaluation on 7/24/25 with an ordered frequency of 1w8. The SN POC stated, “Skilled Nurse…Nurse will perform…oxygen saturation level…at each visit.” The SN failed to document oxygen saturation level for 4 of 8 completed visits: 8/6/25, 8/13/25, 8/27/25, 9/3/25. A review of the agency policy occurred on 9/26/25 titled "Ongoing Assessment" (Reviewed: 9/2/2022) The policy states, "Policy: The scope and intensity of ongoing assessments will be determined by collaborating with the patient regarding the patient’s diagnoses, condition, desire for care, response to previous care, and the care setting. Overview: 1. During each home visit, plan of care review or comprehensive assessment, the appropriate clinician with support of clinical leadership if necessary, will re-evaluate the patient’s status according to the problems identified during the episode. The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings listed above in an interview on 9/26/25 at 10:05 am. Patient #1 (P-1) was admitted to this home care agency on 9/2/25 with the diagnoses of spinal stenosis following lumbar laminectomy with posterior spinal fusion (low back surgery with hardware placement). During record review on 9/23/25, it was noted the plan of care (dated 9/2/25) included an order for occupational therapy (OT) which stated, “Therapist will perform temperature, blood pressure, oxygen saturation level, respiratory rate, and heart rate at each visit.” Upon further review of the record, it was determined the OT notes dated 9/10/25 and 9/17/25 failed to record respiratory rate. Additionally, the OT note dated 9/24/25 failed to include respiratory rate and oxygen saturation level. Patient #2 (P-2) was admitted to this home care agency on 7/2/25 with the diagnosis of hypertension (high blood pressure). During record review on 9/24/25, it was noted the plan of care (dated 7/2/25) included an order for physical therapy (PT) which stated, “Therapist will perform temperature, blood pressure, oxygen saturation level, respiratory rate, and heart rate at each visit.” Upon further review of the record, it was determined the PT assistant (PTA) notes dated 7/17/25 and 8/18/25 failed to include oxygen saturation level. Patient #4 (P-4) was admitted to this home care agency on 8/9/25 with the diagnoses of bilateral radius and ulna (wrist) fractures, hemiplegia following a cerebrovascular accident (weakness on half of the body following a stroke), and type II diabetes mellitus. During record review on 9/25/25, it was noted the plan of care (dated 8/9/25) included an order for occupational therapy (OT) which stated, “Therapist will perform temperature, blood pressure, oxygen saturation level, respiratory rate, and heart rate at each visit.” Upon further review of the record, it was determined the OT assistant (COTA) notes dated 8/13/25, 8/18/25, 8/27/25, and 9/3/25 failed to include oxygen saturation level. The Administrator (Adm-1), Regional Vice President (RVP), and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings during an interview on 9/26/25 at 8:35 AM.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the agency failed to ensure skilled nursing (SN) prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions in 2 (Patient/P-7, P-8) of 2 records in which home health aide (HHa) services were ordered, from a total of 17 sampled records reviewed, resulting in an incomplete list of safety precautions concerning the provision of services and the potential for poor patient outcomes. Findings include: P-7: The patient's start of care (SOC) was 4/6/25, with diagnoses that included hypertensive heart disease, congestive heart failure, and chronic respiratory failure with hypoxia. The plan of care (POC) effective 4/6/25, indicated the following safety precautions: "Ambulation safety, daily weights, emergency/evacuation plan, fall precautions, medication precautions, oxygen precautions, pet safety, and universal precautions." However, review of the HHa POC (4/6/25) noted only two precautions: "Bleeding precautions (if shaving applicable--only with electric razor) and high fall risk." The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged during an interview on 9/26/25 at 11:43 AM., the HHa POC should include all the safety precautions listed on the main or 485/POC. P-8: The SOC to the home care agency was 3/3/25, with diagnoses that included hypertensive heart disease, congestive heart failure, atrial fibrillation, and long-term (current) use of anticoagulants. The plan of care (POC) effective 3/3/25, indicated the following safety precautions: "Adaptive equipment precautions, ambulation safety, anticoagulation precautions, clear pathways, daily weights, emergency/evacuation plan, fall precautions, medication precautions, transfer safety, and universal precautions." However, review of the HHa POC (3/14/25) noted there were no listed safety precautions. The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged during an interview on 9/26/25 at 12:12 PM., that the HHa POC should include all the safety precautions listed on the main or 485/POC.

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 observation, record review and interview, the agency failed to ensure clinical notes were accurate and individualized for 3 (Patient/P-6, P-9, P-10) of 17 records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: Patient #9’s (P-9) Start of Care (SOC) was dated 6/25/25. The Plan of Care (POC) identified diagnoses of Knee Replacement, Hypertension and Anemia. During record review on 9/25/25, it was noted that the Electronic Medical Record (EMR) contained conflicting information for the frequency of visits to be completed by the Physical Therapist (PT). On 6/25/25, the PT completed a comprehensive assessment that stated, “Discipline and Frequency: 3w3 (3 times a week for 3 weeks).” The PT documented a “Coordination Note” on 6/25/25 stating, “Plan of care: Frequency & Duration: 1w8 (1 time a week for 8 weeks). The POC completed by the PT on 6/25/25 stated, “Frequency/Duration of Visits: PT 2w2, 3w1.” The PT failed to ensure documentation was accurate. Patient #10’s (P-10) Start of Care (SOC) was dated 7/16/25. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Atrial Fibrillation and Vascular Disorder of Intestine. During record review on 9/23/25, it was noted that the Occupational Therapist (OT) completed an evaluation on 7/17/25 with an ordered frequency of 1w2 (1 time a week for 2 weeks), 1q2w2 (1 time every two weeks for 2 weeks), 1w4. On 8/2/25 and 8/21/25, the OT documented, “Vital Signs: Oxygen Saturation Characteristics: On oxygen 2 L (Liters), on room air.” The OT failed to accurately document the patient’s oxygen status. A review of the agency policy occurred on 9/26/25 titled "Clinical Record Review" (Reviewed 9/7/2022). The policy states, "Overview: 1.0 As part of an ongoing clinical record review, the clinical record is reviewed by the Compliance and/or Quality Department for: …1.2 The completeness of clinical records. 1.3 The accuracy of clinical records...” The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the findings listed above in an interview on 9/26/25 at 10:15 am. P-6: The patient's start of care (SOC) to the home care agency was on 8/22/25, with diagnoses that included post-surgical laminectomy with discectomy, spinal stenosis, and hypertension. On 9/24/25, record review of P-6's skilled nursing visits notes on 8/29/25, 9/2/25, and 9/8/25 revealed documentation under "Wound Care Provided" by RN-1, that each wound care note had 4,020 identical characters written in auto populated, third person language. In addition, no documentation was evidenced that indicated wound care was performed and what P-6's response was. Instead, the narrative concerning "Wound Care Provided" was based on interventions surrounding vital signs, falls risk, impacts of polypharmacy, teaching/reinforcement relating to cardiovascular status... etc. The Administrator (ADM-1), Regional Vice President (RVP) and Director of Survey Accreditation and Support Service (DSA) reviewed and acknowledged the clinical record regarding the documentation from the above SN visits were not appropriate during an interview on 9/26/25 at 11:28 AM. Administration above further acknowledged this did not meet agency expectations or its policy referenced below.

An unannounced on-site Medicare authorized complaint investigation was conducted for intakes #95083 and #94724 by the Michigan Department of Licensing and Regulatory Affairs on 5/11/23 at: Beaumont Home Health 1975 Technology Drive Troy, MI 48083 The agency has no extension sites or branches. Clinical records reviewed for this survey included 3 records without home visits. The following determinations were made during the investigation: #95083 - Allegation #1: substantiated with citations. #94724 - Allegation #1: unsubstantiated without citations. At the conclusion of the survey, Beaumont Home Health was not in compliance with standard level deficiencies for the Conditions of Participation for Home Health Agencies at: 42 CFR Part 484.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physical therapist and occupational therapist provided services as ordered by the physician in the plan of care for 1 of 1 (MR# 1) record reviewed with physical therapy and occupational therapy services, resulting in the potential for poor patient outcomes for this patient. Findings include: MR#1: This 94-year-old patient was admitted to home care on 12/18/22 with diagnoses of left hip femur fracture, hypertensive chronic kidney disease, and heart failure. The 12/18/22 plan of care orders the physical therapist (PT) to provide two visits each week for eight weeks. During record review on 5/11/23, it was noted that PT failed to provide a second visit in week one. The plan of care orders occupational therapy (OT) to provide two visits each week for three weeks and then one visit each week for four weeks. Record review indicates that OT failed to provide a second visit in week one. There was no documented evidence to indicate the patient had declined these visits and no evidence the physician was informed that visits had not been provided in week one as ordered. The findings were reviewed with and acknowledged by the Administrator (Admin-A) during an interview on 5/11/23 at 2:30 p.m.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide provided care in accordance with the plan of care for 1 of 2 (MR#1) records reviewed in which aide services were provided, resulting in the potential for poor patient outcomes. Findings include: MR#1: This 94-year-old patient was admitted to home care on 12/18/22 with diagnoses of left hip femur fracture, hypertensive chronic kidney disease, and heart failure. The 12/18/22 plan of care orders the aide to provide two visits each week for two weeks. The aide care plan dated the same, also instructs the aide to provide two visits each week for two weeks. During record review on 5/11/23, it was noted that the aide did not provide any of the 4 scheduled visits. There was no documented evidence to indicate the patient had declined these visits and no evidence the physician was informed that visits had not been provided in weeks one and two as ordered. A coordination note dated 1/10/23, documents that the aide visits were missed on 12/20, 12/21, 12/23, and 12/28 because the aide was unable to coordinate care. There was no documentation of the aide's efforts to coordinate the care with the patient or caregiver. The coordination note states that the physician's office was closed at 10:10 p.m. and the information was faxed. This information was faxed to the physician almost two weeks after the aide care was not provided as ordered. The findings were reviewed with and acknowledged by the Administrator (Admin-A) during an interview on 5/11/23 at 2:30 p.m.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical manager provided oversight and coordination of patient care services and personnel regarding the provision of physical therapy, occupational therapy, and home health aide services for 1 of 1 (MR#1) record reviewed with these services, resulting in a lack of patient care and the potential for poor patient outcomes. Findings include: MR#1: This 94-year-old patient was admitted to home care on 12/18/22 with diagnoses of left hip femur fracture, hypertensive chronic kidney disease, and heart failure. The 12/18/22 plan of care orders the agency to provide physical therapy (PT), occupational therapy (OT), and aide services twice a week. During record review on 5/11/23, it was noted that both PT and OT failed to provide a second visit in week one. The aide failed to provide any visits in weeks one and two. There was no documented evidence to indicate the patient had declined these visits. There was no evidence the clinical manager provided oversight of personnel and ensured the coordination of services for this patient in need of therapy services and assistance with personal hygiene and other activities of daily living. The findings were reviewed with and acknowledged by the Administrator (Admin-A) during an interview on 5/11/23 at 2:30 p.m.

An Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 10/3/22-10/6/22 at: Beaumont Home Health 1975 Technology, Suite J120 Troy, MI 48083 The agency had no extension sites at the time of this survey. At the survey's conclusion, the agency was found to be out of compliance, at the standard level, with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to include individual emergency preparedness plans for each patient as part of the comprehensive assessment, for all 17 records reviewed, resulting in the agency's inability to ensure patient safety during an emergency, which could result in the agency not providing quality health care. Findings include: During record review, and review of the emergency preparedness program from 10/3/22-10/6/22, it was discovered that none of the 17 records reviewed had an individual emergency preparedness plan documented in their individual comprehensive assessment. There were emergency preparedness reports in each record. However, the report was essentially a copy of the plan of care (POC). The report did not have any emergency preparedness related information documented. During an interview on 10/6/22 at 2:25 p.m., the administrator (Adm #1) and the director of nursing (DON #1) acknowledged the above findings.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency's Emergency Preparedness (EP) plan, policies, and procedures, failed to address the use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency, affecting all agency patients, resulting in the clinic's inability to respond effectively in the event of an emergency. Findings include: During a review of the agency's EP plan, policies, and procedures on 10/6/22, it was discovered that there was no language that included a process for utilizing volunteers or other health care professionals during surge periods. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm#1) and the director of nursing (DON #1) acknowledged the findings.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness (EP) training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and the communication plan. The training and testing program must be reviewed and updated at least every two years. This deficient practice could affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: During review of the agency's EP program on 10/6/22 at 10:30 a.m., It was discovered that there was no documented evidence that the agency had developed a training and testing program to guide personnel and agency actions during an emergent situation. There was no documentation where all staff were involved in testing of the EP plan or EP drills. All agency patients could be impacted by the agency's failure to develop and maintain an EP training and testing program. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings.

The following Condition and Standard level deficiencies were identified during a Medicare authorized Recertification survey, concurrent with the Vaccine Mandate protocol survey and complaint investigations (#71509 and #71988), conducted by the Michigan Department of Licensing and Regulatory Affairs on 10/3/22 through 10/6/22 at: Beaumont Home Health 1975 Technology, Suite J120 Troy, MI 48083 Services Offered: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Work, Home Health Aide. This Agency did not have any additional sites under this known provider number. Record reviews included 7 with home visits, 10 without home visits for a total of 17 records reviewed. At the conclusion of the survey, the Agency was determined to be non-compliant with the following Conditions of Participation: 42 CFR §484.65 Quality Assessment and Performance Improvement. 42 CFR §484.70 Infection Prevention and Control. 42 CFR §484.75 Skilled Professional Services. 42 CFR §484.80 Home Health Aide Services. 42 CFR §484.115 Personnel Qualifications. Results of the Complaint Investigations revealed: Complaint #71509: Allegation 1) It was alleged the facility failed to keep their scheduled appointments to see the patient at the start of care - Substantiated. See G 514. Complaint #71988: Allegation 1) It was alleged the facility failed to ensure staff showed up for the scheduled appointments, resulting in a delay in the provision of services - Substantiated. See G 572. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(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 record review and interview, the Agency failed to include contact information for the Home Health Agency's Administrator in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed concerns for all patients serviced by this agency. Findings include: Policy: Patient Bill of Rights and Responsibilities QA-001 HH 7/8/21 stated, "...To speak with the Agency Administrator and be provided with that contact information..." On 10/3/22 at 11:00 a.m., the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and a patient rights and responsibilities booklet. Upon review, it was noted that there was no contact information for the Agency's Administrator (Adm #1). These findings were reviewed with and confirmed by Adm #1 and the Director of Nursing (DON #1) during the exit conference on 10/6/22 at 3:15 p.m.

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 observation, interview and record review, the Agency failed to ensure that 6 (MR's #1, 2, 3, 7, 13, 15) of 7 patients observed during home visits, from a total of 17 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, resulting lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: MR #7: The patient's SOC was 9/21/22, with diagnoses that included heart disease, ischemia and left bundle branch block. During record review on 10/3/22, it was noted that skilled nursing (SN), physical therapy (PT), and occupational therapy were ordered. During a surveyor home visit on 10/3/22 at 3:00 p.m., it was discovered that the calendar in the patient's home was blank. There were no proposed visits documented for the patient. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. Policy: Patient Bill of Rights and Responsibilities QA-001 HH 7/8/21 stated, "Each patient will be an active, informed participant in his/her plan of care, To participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate with respect to Completion of your health assessment, The care we will furnish based upon the, assessment, Establishing the care that you will receive (The Plan of Care), The types of care that you will receive such as Skilled Nursing, Physical Therapy etc. and the frequency that the visits will occur." MR #1: The patient's start of care (SOC) was 8/19/22 with diagnoses that included Cervicalgia and spinal Stenosis. During the clinical record review on 10/4/22 at 12:40 p.m., it was noted that Skilled Nursing (SN), Physical Therapy (PT), Occupational therapy (OT) and Medical Social Work (MSW) services were ordered to be provided. On 10/3/22 at 12:45 p.m., a home visit was conducted with the Licensed Practical Nurse (LPN #1). During a review of the patient's admission packet, it was noted that there was no calendar of proposed visits to be made by any of the above ordered disciplines. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:19 p.m. MR #2: The patient's SOC was 9/16/22 with diagnoses that included Cancer of Uterus and Fallopian tube. During the record review on 10/4/22 at 2:11 p.m., it was noted that the Plan of Care (POC) ordered SN and PT services to be provided. On 10/3/22 at 2:00 p.m., during a joint home visit with the Registered Nurse (RN #1), it was noted that there was no calendar of proposed visits to be made by the ordered disciplines. These findings were reviewed with and acknowledged by Adm #1 during an interview on10/4/22 at 4:37 p.m. MR #3: The patient's SOC was 10/3/22 with diagnoses that included Bladder Cancer. During the record review on 10/4/22 at 3:30 p.m., it was noted that the POC ordered SN and PT services to be provided. On 10/4/22 at 1:00 p.m., during a schedule home visit with the Physical therapist (PT #1), it was noted that the calendar which was to include a schedule of proposed visits to be made by the ordered disciplines was left blank. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/4/22 at 5:03 p.m. MR#13: The start of care (SOC) date was 9/16/2022 with a diagnoses history that included coronary artery disease, chronic obstructive pulmonary disease and diabetes-type2. On 10/4/22, record review noted the plan of care (POC) dated 9/16/22, ordered skilled nursing (SN), physical therapy (PT), occupational therapy (OT), and home health aide (HHa) services. It was observed on 10/4/22 during a home visit with HHa services, that the patient calendar with the above ordered disciplines was blank except for the SOC by SN on 9/16/22 and the PT evaluation on 9/23/22 which represented only 2 of 14 clinical visits made at the time of observation. The findings were reviewed with and acknowledged by the Administrator and Director of Nursing during an interview on 10/6/22 at 10:46 AM. MR#15: The SOC date was 7/15/2022 and re-certified on 9/13/22, with diagnoses that included pressure ulcer of right heel-stage 3, hypertension, and drug-induced polyneuropathy (peripheral nerve damage). The re-certification POC dated 9/13/22 ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHa) services. It was observed on 10/4/22 during a home visit with OT services, that the patient calendar with the above ordered disciplines was blank except for the lone entry by SN on 7/15/22. In addition, during an interview with the patient during the home visit, it was revealed the patient was dissatisfied with the lack of coordination concerning the scheduling of upcoming visits by SN. These findings were reviewed with and acknowledged by the Administrator and Director of Nursing during an interview on 10/6/22 at 11:12 AM.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to inform the patient/caregiver before care was initiated of the extent to which payment for home health agency services may be expected from Medicare or other insurance sources and the extent to which payment may be required from the patient for 2 of 3 patients observed during home visits, from a total of 17 sampled records reviewed, resulting in the potential for undisclosed charges. Findings included: MR #1: The patient's start of care (SOC) was 8/19/22 with diagnoses that included Cervicalgia and spinal Stenosis. During the clinical record review on 10/4/22 at 12:40 p.m., it was noted that Skilled Nursing (SN), Physical Therapy (PT), Occupational therapy (OT) and Medical Social Work (MSW) services were ordered to be provided. On 10/3/22 at 12:45 p.m., a home visit was conducted with the Licensed Practical Nurse (LPN #1). During a review of the patient's admission packet, it was noted that the consent form which discussed payments for services, was left blank. There was no indication that the discussion of payment for services had been conducted prior to the provision of care and prior to the next scheduled home visit. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:19 p.m. MR #2: The patient's SOC was 9/16/22 with diagnoses that included Cancer of Uterus and Fallopian tube. During the record review on 10/4/22 at 2:11 p.m., it was noted that the Plan of Care (POC) ordered SN and PT services to be provided. On 10/3/22 at 2:00 p.m., a joint home visit was conducted with the Registered Nurse (RN #1). During a review of the patient's admission packet, it was noted that the consent form which discussed payments for services, was left blank. There was no indication that the discussion of payment for services had been conducted prior to the provision of care and prior to the next scheduled home visit. These findings were reviewed with and acknowledged by Adm #1 during an interview on10/4/22 at 4:37 p.m.

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 document review, policy review and interview, the agency failed to ensure the initial assessment visit was conducted within 48 hours of referral for 1 of 17 records reviewed (MR #14), from a total sample of 17 records reviewed, resulting in a delay in determining the patient's immediate care and support needs. Findings include: Agency Policy: "Initial and Comprehensive Assessment" QA-011 HH (Revised 7/2021) stated, "1.2. The initial assessment must be performed either... 1.2.1 Within 48 hours of the valid referral... 1.2.4 At the patient/family request with the approval of the physician or other authorized licensed independent practitioner." MR#14: Review of the referral for home care for MR#14 documented the patient was to be discharged from Shelby Health and Rehabilitation Center on 8/12/2022 and a SOC (Start of Care) date of 8/13/22 to the Home Health Agency. Further review of record noted a coordination note dated 8/13/2022 at 1:01 PM which documented, “RN liaison spoke with patient’s daughter. Apologized and stated that we are trying to find a clinician to come out for SOC. Told daughter that if a nurse is unable to come out today, the visit will be moved to either Sunday or Monday. Daughter thanks nurse for calling back and confirming.” No further clinical entries were found on 8/13/22. The next clinical entry was another coordination note dated 8/14/22 at 3:57 PM., which documented the following: “RN called and spike with pt (patient) daughter who stated todsy was not going to be a good day and would like a visit tomorrow at 9AM. RN explained thst visit will be sent back to office and rescheduled but not sure what time tomorrow. (sic) On 8/15/22 at 7:27 PM, a coordination note by the evening nurse was entered which documented, “Patient’s daughter stated that she does not want any services from Beaumont Homecare including therapies.” The last clinical entry on 8/15/22 at 7:31 PM (coordination note) documented, “Provider notification of SOC delayed due to patient refusing visit.” No evidence was found in the medical record of the patient/caregiver was wanting to delay services other than 8/14/2022. An interview with the Administrator (Adm. #1) on 10/6/22 at 1:18 PM noted the Agency’s call logs confirmed the first attempt to contact the patient to set up the SOC visit on 8/15/22 was at 7:27 PM. Adm. #1 acknowledged this did not meet Agency expectations and there was an opportunity for improvement. Review of the medical record found the Agency had ample opportunity on 8/13/22 and again on 8/15/22 to coordinate care and furnish the SOC visit with the patient/family. The agency failed to follow its own policy and ensure the initial assessment visit was completed within 48 hours of referral.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status and events that lead to the need for home care, in 7 (MR's #1, 4, 5, 6, 7, 8, 9) of 7 records, from a total of 17 sampled records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients and for measuring the patient's progress toward goals/outcomes. Findings include: MR #6: The patient's SOC was 5/19/2020, with diagnoses that included heart disease, chronic kidney disease, heart failure and diabetes. During record review on 10/3/22, it was discovered under section ICD 10-Diagnoses and Procedures on the Comprehensive Assessment, the only information provided was a list of diagnoses. There was no information providing dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. MR #7: The patient's SOC was 9/21/22, with diagnoses that included heart disease, ischemia and left bundle branch block. During record review on 10/3/22, it was discovered under section ICD 10-Diagnoses and Procedures on the Comprehensive Assessment, the only information provided was a list of diagnoses. There was no information providing dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. MR #8: The patient's SOC was 8/10/22, with diagnoses that included liver transplant, kidney failure and dialysis. During record review on 10/4/22, it was discovered under section ICD 10-Diagnoses and Procedures on the Comprehensive Assessment, the only information provided was a list of diagnoses. There was no information providing dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. MR #9: The patient's SOC was 8/26/22, with diagnoses that included type 2 diabetes, heart failure and Alzheimer's. During record review on 10/5/22, it was discovered under section ICD 10-Diagnoses and Procedures on the Comprehensive Assessment, the only information provided was a list of diagnoses. There was no information providing dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. Policy: Initial and Comprehensive Assessment QA-011 HH, 7/14/21 stated, "Comprehensive assessment is patient specific and reflects the patients: Current health, psychological, and functional and cognitive status, Continuing need for home care..." MR #1: The patient's Start of Care (SOC) was 8/19/22 with diagnoses that included Cervicalgia and Spinal Stenosis. During the record review on 10/4/22 at 12:40 p.m., it was noted that the Initial Comprehensive Assessment dated 8/19/22 completed by the RN revealed: All listed diagnoses had the same dates of exacerbation, 8/19/22. There was no other history provided and no history of the events that lead to the need for home care referral. The RN documented the presence of right and left lower extremity edema, however there were no associated measurements. The assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:19 p.m. MR #4: The patient's Start of Care (SOC) was 4/14/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure and Congestive Heart Failure. During the record review on 10/5/22 at 9:30 a.m., it was noted that the Initial Comprehensive Assessment dated 4/14/22 completed by the RN revealed: All listed diagnoses had the same dates of exacerbation, 4/14/22. There was no other history provided and no history of the events that lead to the need for home care referral. The patient had a diagnosis of Diabetes Mellitus; however, no baseline blood sugar was recorded. The assessment documented "What is the client's high/low blood glucose range" to which a range of 200 was listed. The assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. The assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/5/22 at 1:32 p.m. MR #5: The patient's SOC was 10/1/22 with diagnoses that included Hypertensive Heart disease, Congestive Heart Failure and Diabetes Mellitus. During the record review on 10/6/22, it was noted that the Initial Comprehensive Assessment dated 10/1/22 completed by the RN revealed: All listed diagnoses had the same dates of exacerbation, 10/1/22. There was no other history provided and no history of the events that lead to the need for home care referral. The documented baseline weight of 159 pounds did not indicate actual or reported. There was no baseline blood sugar recorded and no assessment of edema. The assessment failed to paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by Ad #1 during an interview on 10/6/22 at 9:06 a.m.

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 record review and interview, it was determined the Agency (HHA) failed to ensure the start of care (SOC) comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required, failed to ensure a skilled nurse reviewed all medications, and failed to ensure the physician was notified of potential drug interactions in 8 records (MR's #6, 7, 8, 10, 11, 12, 13, 16), from a total of 17 records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: MR #6: The patient's SOC was 5/19/2020, with diagnoses that included heart disease, chronic kidney disease, heart failure and diabetes. During record review on 10/3/22, it was discovered that section M2001, of the Initial Comprehensive Assessment stated, "No issues found during review." The patient's medications were entered into Drugs.com and found the following: 2 severe drug interactions. There was no documentation in the record that the physician was notified of the medication interactions. MR #7: The patient's SOC was 9/21/22, with diagnoses that included heart disease, ischemia and left bundle branch block. During record review on 10/3/22, it was discovered that section M2001, of the Initial Comprehensive Assessment stated, "No issues found during review." The patient's medications were entered into Drugs.com and found the following: 10 moderate interactions, 2 minor, 4 food and 2 duplications. There was no documentation in the record that the physician was notified of the medication interactions. During a surveyor home visit on 10/3/22, it was discovered that 10 patient medications were found in the home. The plan of care (POC), printed by the agency on 10/3/22, had 3 medications documented. MR #8: The patient's SOC was 8/10/22, with diagnoses that included liver transplant, kidney failure and dialysis. During record review on 10/4/22, it was discovered that section M2001, of the Initial Comprehensive Assessment stated, "No issues found during review." The patient's medications were entered into Drugs.com and found the following: 2 severe drug interactions. There was no documentation in the record that the physician was notified of the medication interactions. MR #10: The patient's SOC was 8/17/20, with diagnoses that included dysphagia, diverticulitis and diabetes mellitus. During record review on 10/5/22, it was discovered that the SOC comprehensive assessment, signed by speech therapy, documented under section M2001, "No issues found during review." The patient's medication report dated 8/17/20, was signed by the speech therapist. All medications were entered into Drugs.com and found the following: 4 major drug interactions, 8 moderate, 3 minor, 6 food and 3 duplications. There was no evidence in the record that a skilled nurse reviewed the medications, and no documentation in the record that the physician was notified of the medication interactions. MR #11: The patient's SOC was 8/31/22, with diagnoses that included pulmonary embolism, anemia, and anticoagulant use. During record review on 10/6/22, it was discovered that the SOC comprehensive assessment, signed by physical therapy, documented under section M2001, "No issues found during review." The patient's medication report dated 8/31/22, was signed by the physical therapist. All medications were entered into Drugs.com and found the following: 1 major drug interaction, and 2 food interactions. There was no evidence in the record that a skilled nurse reviewed the medications, and no documentation in the record that the physician was notified of the medication interactions. During an interview on 10/6/22 at 2:25 p.m., when asked about the therapists signing the medication report, and no evidence in the therapy only records, of an RN doing a medication reconciliation, the administrator (Adm #1) and the director of nursing (DON #1) stated, "The registered nurse (RN) cosigns the therapy only POC's, which counts as a medication reconciliation." A POC is not a medication reconciliation. A POC has a list of medications but does not document whether or not there are interactions. Agency Policy: "Medication Profile" QA-033 HH (Revised 9/2021) stated, "Patients receiving medications will have a current, accurate medication profile in the clinical record... The review will identify drug interactions, duplicative drug therapy, and noncompliance with drug therapy... Medication Interaction: All interactions require physician notification via a phone call and documentation in PointCare... A higher severity interaction (2 or 3) should include a request of urgency when leaving a message for the physician. MR#12: This patient's start of care (SOC) was 6/10/22, with diagnoses that included congestive heart failure, chronic kidney disease and anemia. On 10/5/22, record review noted section M2001 (Medications) of the Initial Comprehensive Assessment performed by RN#2 on 6/10/22, had indicated "No issues found during review." However, the agency's own drug review software revealed a severe interaction which warranted physician notification. Also, when the patient's 18 prescribed medications at the SOC were entered into "Drugs.com" (professional online drug interaction checker), the following was revealed: 2 Major (severe) drug to drug interactions and 2 duplicative drug therapies. No evidence was found in the clinical record that the physician was notified as stipulated by the agency's policy above. During an interview on 10/6/22 at 10:20 AM., the Administrator and Director of Nursing had confirmed all the above findings during a joint review of the clinical record with the surveyor. MR#13: The start of care (SOC) date was 9/16/2022 with a diagnoses history that included coronary artery disease, chronic obstructive pulmonary disease and diabetes-type2. On 10/5/22, record review noted section M2001 of the Initial Comprehensive Assessment performed by RN#2 on 9/16/22, had indicated "No issues found during review." However, the agency's own drug review software revealed a severe interaction and when the patient's 16 prescribed medications at the SOC were entered into "Drugs.com" the following was revealed: 4 Major drug to drug interactions and 4 duplicative drug therapies. No documentation was found that indicated the physician was notified of the above findings. MR#16: The start of care (SOC) date was 9/8/2022 with diagnoses that included congestive heart failure, chronic kidney disease, and anemia. During review of the clinical record on 10/5/22, it was documented that the patient's medication review at the SOC was performed by PT#2 (physical therapist), which was the only discipline assigned to the case. No evidence of a subsequent review of the patient's medications by a registered nurse (RN) was found in the medical record. Further, PT#2 documented under section M2001 of the Initial Comprehensive Assessment (9/8/22), "No issues found during review." However, the agency's own drug review software revealed 2 severe interactions, and when the patient's 15 prescribed medications at the SOC were entered into "Drugs.com" the following was revealed: 5 Major drug to drug interactions and 4 duplicative drug therapies. No documentation was found that indicated the physician was notified of the above findings. During an interview on 10/6/22 at 11:20 AM., the Administrator and Director of Nursing had confirmed the above findings and acknowledged the agency failed to adhere to its own policy as stipulated above.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure 4 (MR #6, 9, 11, 17) of 17 patients received care and services as written in the patient's individualized plan of care (POC), from a total of 17 records reviewed, resulting in the potential for unmet care needs and further physical decline. Findings include: MR #6: The patient's start of care (SOC) was 5/19/20, with diagnoses that included heart disease, chronic kidney disease, heart failure, and diabetes. During record review on 10/3/22, it was noted that the POC ordered skilled nursing (SN) for 2 times a week for 2 weeks, 1 time a week for 2 weeks, 1 every 2 weeks for 2 weeks, 7 times a week for 1 week (Effective 6/28/22), and 1 visit a week for 2 weeks. During review of clinician visits, it was discovered that SN only provided 1 visit during week 7 (7 times a week for 1 week was ordered). There was no documentation in the record to explain why SN services were not provided, and there was no documented evidence the Physician was notified of SN services not being provided as ordered. MR #9: The patient's SOC was 8/26/22, with diagnoses that included heart disease, heart failure, and diabetes. During record review on 10/5/22, it was discovered that the POC ordered SN for 1 time a week for 1 week, 2 times a week for 2 weeks, and 1 time a week for 6 weeks. Home health aide (HHa) was ordered for 2 times a week for 2 weeks. During review of clinician visits, it was discovered that SN had a missed visit for week 2, and HHa missed 2 visits during week 2, with no documented reason for the missed visits. There was no documented evidence the physician was notified of the services not being provided as ordered. MR #11: The SOC was 8/31/22, with diagnoses that included pulmonary embolism, anemia, and anticoagulant use. The POC reviewed on 10/6/22 documented medical social worker (MSW) for 1 time a week for 1 week, and HHa for 1 time a week for 1 week, 2 times a week for 1 week, and 1 time a week for 1 week. During review of clinician visits, it was discovered that MSW and HHa never made a visit, with no documented reason for the services not being provided. There was no documented evidence the physician was notified of the services not being provided as ordered. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. MR #17: The patient's start of care (SOC) was 8/26/22, with diagnoses that included pressure ulcer of sacral region-stage 3, hypothyroidism, and pulmonary hypertension. On 10/4/22, record review noted the plan of care (POC) ordered a skilled nursing (SN) frequency of 1w1 (once a week for one week), 2W1, and 1W7. The POC (8/26/22) ordered SN to perform urinary catheter changes monthly. SN was due to complete the catheter order during week five of the certification period. However, no documentation was found in the clinical record that SN had performed any care during week 5 as ordered. Documentation of patient/caregiver refusal of services and physician notification concerning the missed visit was not found during week 5 of the clinical record. During an interview with the Administrator and Director of Nursing on 10/6/22 at 11:40 AM., it was acknowledged through joint record review that SN had missed the scheduled visit and failed to furnish the order timely on the patient's POC.

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 covered all pertinent interventions with reportable parameters, safety measures and objectively measurable goals specific to the individualized needs of the patient in 9 (MR's #1, 2, 4, 5, 6, 11, 12, 13, 16) records, from a total of 17 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 8/19/22 with diagnoses that included Cervicalgia, Spinal Stenosis and Hypertension. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical therapy (PT), Occupational Therapy (OT) and Medical Social Work (MSW) services to be provided. The Initial Comprehensive Assessment dated 8/19/22 documented a baseline pain rating of 8/10. During the record review on 10/4/22 at 12:40 p.m., it was noted that the POC did not include reportable pain parameters in which to notify the Physician. Further, the POC was vague in nature, such as, "Nurse may perform..." assessment tasks. The POC failed to address the individualized needs of the patient. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:19 p.m. MR #2: The patient's SOC was 9/16/22 with diagnoses that included Cancer of Uterus and Fallopian Tube with colostomy and urostomy placement. The POC ordered SN, PT and Home Health Aide services to be provided. On 10/3/22 at 2:00 p.m., a scheduled home visit was conducted with the Registered Nurse (RN #1). The patient had an abdominal would with 13 staples in place. During the visit, RN #1 instructed the patient on checking her blood sugars. The patient then stated that she was not diabetic. The POC did not include interventions that addressed the patient's staples and listed a diagnosis of Hyperglycemia (elevated blood sugar) which was not associated with this patient. Additionally, the narrative read, "Reinforcement of care for Anal Breast Cancer..." which was not an actual diagnosis. The POC failed to address the individualized needs of the patient. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/4/22 at 4:37 p.m. MR #4: The patient's SOC was 4/14/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure and diabetes Mellitus. During the clinical record review on 10/5/22 at 9:30 a.m., it was noted that the POC failed to include reportable parameters in which to notify the Physician that addressed the patient's weights and edema. Additionally, there were no interventions to address the diagnosis of Congestive Heart Failure. The POC did not address the individualized needs of the patient. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/5/22 at 1:36 p.m. MR #5: The patient's SOC was 10/1/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Coronary Artery Disease and Congestive Heart Failure. During the record review on 10/5/22, it was noted that the POC was void of interventions, reportable parameters and associated goals that address the patient's diagnosis of Congestive Heart Failure. The POC did not address the individualized needs of the patient. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/6/22 at 9:07 a.m. MR #6: The SOC was dated 5/19/20, with diagnoses that included heart disease, chronic kidney disease, heart failure, and type 2 diabetes. During review of the Plan of Care (POC) on 10/3/22, it was documented that the patient was a diabetic with heart failure. During further review of the POC, it was discovered that no diabetic precautions, blood sugar parameters or heart failure parameters were documented. MR #11: The SOC was dated 8/31/22, with diagnoses that included pulmonary embolism, anemia, and anticoagulant use. During review of the POC on 10/6/22, it was documented that there were no bleeding/anticoagulant precautions for a patient on Eliquis (Anticoagulant). During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. MR#12: This patient's start of care (SOC) was 6/10/22, with diagnoses that included congestive heart failure (CHF), chronic kidney disease and anemia. On 10/5/22, review of the patient's POC failed to incorporate safety parameters which to notify the physician and pertinent interventions needed to appropriately monitor for exacerbation (worsening) of the patient's clinical baseline concerning congestive heart failure and diabetes with neuropathy (nerve damage due to diabetes). In addition, the POC orders for skilled nursing (SN) were written in a manner which allowed SN an option not to perform essential clinical assessments (i.e., temperature and blood pressure readings, blood oxygen levels, respiratory and heart rate). During an interview on 10/6/22 at 10:18 AM., the Administrator and Director of Nursing had confirmed the above findings and acknowledged the POC should include safety parameters, pertinent interventions, and that it was not "optional" for SN not to obtain essential baseline data during the clinical visits. MR#13: The start of care (SOC) date was 9/16/2022 with a diagnoses history that included coronary artery disease, chronic obstructive pulmonary disease (COPD) and diabetes-type2. The plan of care (POC) dated 9/16/22 ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHa) services. On 10/5/22, review of the patient's POC listed only one (coronary artery disease) of the 15 listed diagnoses found on the patient's referral (dated 9/11/22) for home care. Subsequently, pertinent diagnoses with corresponding safety parameters and skilled interventions for diabetes, COPD, and severe pain were not found. In addition, the POC orders were written that allowed SN not to perform for example, the patient's blood pressure during the clinical visit. However, the information within the referral for home care noted the following ED (emergency dept.) clinical documentation obtained on 9/11/22: Blood pressure of 187/96 (severe) and blood sugar of 164, which established the clinical need for further monitoring that would be reflected in the patient's POC. During an interview on 10/6/22 at 10:43 AM., the Administrator and Director of Nursing had confirmed the above findings and acknowledged the POC should include all established medical diagnoses with corresponding appropriate provisions of care. MR#16: The start of care (SOC) date was 9/8/2022 with diagnoses that included congestive heart failure (CHF), chronic kidney disease, and anemia. During review of the clinical record on 10/5/22, it was noted the patient's primary diagnosis of CHF listed in the POC, had no safety parameters which to notify the physician and pertinent interventions needed to appropriately monitor for exacerbation of the patient's congestive heart failure symptoms. During an interview on 10/6/22 at 11:17 AM., the Administrator and Director of Nursing had confirmed the above findings and acknowledged the POC had failed to meet agency expectations.

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 ensure the Physician was promptly notified of significant changes in the patient's condition for 1 (MR #4) of 1 patient with an elevated weight and elevated blood glucose level, and complaints of swelling and heaviness to her lower extremity, from a total sample of 17 records reviewed, resulting in the potential for poor patient outcomes, untreated health concerns and unmet care needs. Findings include: Policy: Physician Notification OP-021 HH 8/27/21 stated, "Purpose: To provide guidelines for notifying the physician of changes in the patient’s condition/adjustment to the plan of care..., Agency clinical staff are responsible for knowing and adhering to this policy..., The patient’s physician will be contacted for the following: Changes in the patient’s condition, Changes in the patient’s psychosocial status, Changes in the patient’s home environment, Inability to achieve goals or improve outcomes within the specified time frame, To report patient’s response to care, Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions, and limitations..." MR #4: The patient's start of care was 4/14/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure and diabetes Mellitus. The Plan of Care (POC) ordered Skilled Nursing, Home Health Aide, Physical Therapy, Occupational Therapy and Medical Social Work services to be provided. During the record review on 10/5/22 at 9:30 a.m., it was noted that the patient had a baseline weight of 178 pounds (lbs.) at the time of admission and was later hospitalized on 4/17/22 due to complications of her disease process. The patient resumed care under the Agency's services on 5/14/22, at which time she had a recorded weight of 196 lbs. The patient continued to receive the above ordered services and had a documented weight of 196 lbs. on 5/16/22 and 5/18/22. On 5/28/22, the Certified Occupational Therapy Assistant (COTA) documented the patient's weight as 210 lbs. This reflected a 14 lb. weight gain. There was no documented evidence that the Physician had been notified of this change in condition. The patient had an elevated blood glucose level of 390 on 5/20/22. Again, there was no documentation of Physician notification. Additionally, during a Physical Therapy visit on 6/8/22, the Therapist documented the patient complained of her left leg feeling heavy and being swollen. There was no documented evidence that the Physician had been promptly notified. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/5/22 at 1:32 p.m. who reported, "The Doctor should have been notified and it should have been documented."

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, interview and record review, it was determined that the Agency failed to provide 5 (MR#'s 1, 2, 3, 7, 15) of 7 patients observed during home visits, with a Medication Profile that included the names, dosages and frequencies of the patient's prescribed medications, in plain language, from a total of 17 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: MR #1: The patient's start of care (SOC) was 8/19/22 with diagnoses that included Cervicalgia and Spinal Stenosis. On 10/3/22 at 12:45 p.m., a joint survey home visit was conducted with the Licensed Practical Nurse (LPN #1). During a review of the patient's admission packet, it was noted that there was no Medication Profile that listed the patient's prescribed medications, dosages and side effects. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:19 p.m. MR #2: The patient's SOC was 9/16/22 with diagnoses that included Cancer of Uterus and Fallopian tube. A joint home visit was conducted with the Registered Nurse (RN #1) on 10/3/22 at 2:00 p.m. During a review of the patient's admission packet, it was noted that there was no Medication Profile in the patient's folder that listed the patient's prescribed medications, dosages and side effects. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/4/22 at 4:37 p.m. MR #3: The patient's SOC was 10/3/22 with diagnoses that included Bladder Cancer. On 10/4/22 at 11:00 a.m., a joint survey home visit was conducted with the Physical Therapist (PT #1). During a review of the patient's admission packet, it was noted that there was no Medication Profile that listed the patient's prescribed medications, dosages and side effects. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/4/22 at 5:03 p.m. MR #7: The patient's SOC was 9/21/22, with diagnoses that included heart disease, ischemia and left bundle branch block. During a surveyor home visit on 10/3/22, it was discovered that there was no Medication Profile listing the patient's prescribed medications, dosages and side effects in the patient's home care folder for reference. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. Agency Policy: "Medication Profile" QA-033 HH (Revised 9/2021) stated, "Each patient will receive appropriate written material from the pharmacy and/or clinician for specific medications he/she is receiving as needed. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the specific medication." MR#15: The SOC date was 7/15/2022 and re-certified on 9/13/22, with diagnoses that included pressure ulcer of right heel-stage 3, hypertension, and drug-induced polyneuropathy (peripheral nerve damage). It was observed on 10/4/22 during a home visit with OT services, that the "Patient Medication Tracking Form" found inside the patient's admission packet was left blank. These findings were reviewed with and acknowledged by the Administrator and Director of Nursing during an interview on 10/6/22 at 11:12 AM. The agency failed to follow its own policy noted above and provide pertinent information concerning the patient's current medications.

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 include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. Findings include: On 10/3/22, the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's Clinical Manager. These findings were reviewed with and confirmed by the Administrator (Adm #1) and Director of Nursing (DON #1) during the exit conference on 10/6/22 at 3:15 p.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on document review and interview, it was determined the agency failed to provide evidence of a Quality Assessment and Performance Improvement (QAPI) program that measured, tracked, and analyzed it's quality indicators in order to quantitatively assess outcomes concerning care and services furnished by the agency (See G 642); failed to provide data collected which monitored the QAPI program to determine the effectiveness, safety of services, and quality of care to identify opportunities for improvement (See G 644); failed to produce evidence that the quality improvement projects for 2020, 2021 and 2022 to date, were put to use with measurable progress achieved on these projects (See G 658); and failed to ensure the Governing Body had incorporated an effective means in which to access the agency's data collected to evaluate the QAPI program, resulting in the potential to negatively affect the quality of care to all 3140 patients currently receiving services (See G 660). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all 3140 patients the home health agency is currently serving for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the agency failed to provide evidence of a Quality Assessment and Performance Improvement (QAPI) program that measured, tracked, and analyzed its quality indicators to quantitatively assess outcomes concerning care and services furnished by the agency, resulting in the potential to negatively affect all 3,140 patients currently serviced by the agency. Findings include: A final attempt was made on 10/6/2022 at 3:00 PM., to review the agency's QAPI documentation after an initial notification on 10/5/22 at 4:30 PM., to have the QAPI program documentation ready for review the following morning. Previous requests on 10/6/22 were also noted at 9:45 AM and 11:50 AM. No documentation to support the agency's QAPI program was provided by the survey's conclusion on 10/6/22 at 3 PM. During an interview on 10/6/22 at 2:40 PM., the Administrator acknowledged the Agency had failed to provide any QAPI program data to review which showed measurable improvements in indicators to improve patient outcomes, safety, and quality of care.

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 document review and interview, it was determined the agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the quality assessment and performance improvement program (QAPI), which had the potential to negatively affect all 3,140 patients currently serviced by this agency, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: A final attempt was made on 10/6/2022 at 3:00 PM., to review the agency's QAPI program data for 2020, 2021 and 2022 to date after an initial notification on 10/5/22 at 4:30 PM., to have the QAPI program documentation ready for review the following morning. Previous requests on 10/6/22 were also noted at 9:45 AM and 11:50 AM. Evidence of the agency's QAPI program data that measured, tracked, or analyzed its effectiveness was not furnished by the survey's conclusion on 10/6/22 at 3 PM. During an interview on 10/6/22 at 2:40 PM., the Administrator acknowledged the agency had not provided the requested QAPI program data.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the agency failed to develop a Quality Assessment Performance Improvement (QAPI) program that documented the annual performance improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for 2020, 2021, and 2022 to date, resulting in the agency's inability to show improvement in areas concerning quality of patient care, health outcomes, and patient safety. Findings include: A final attempt was made on 10/6/2022 at 3:00 PM., to review the agency's QAPI performance improvement projects, reasons for conducting the projects along with measurable progress achieved for 2020, 2021 and 2022 to date, after an initial notification on 10/5/22 at 4:30 PM. Previous requests on 10/6/22 were also noted at 9:45 AM and 11:50 AM. Evidence of the agency's QAPI performance improvement projects were not provided by the survey's conclusion on 10/6/22 at 3:00 PM. During an interview on 10/6/22 at 2:40 PM., the Administrator acknowledged the agency had failed to provide documentation that showed the development and utilization of any performance improvement projects from 2020 through the survey's exit date of 10/6/22.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency's Governing Body failed to implement an effective means to access collected data used to evaluate its Quality Assessment and Performance Improvement (QAPI) program, resulting in the potential to adversely affect the quality of care to all 3,140 patients currently receiving services. Findings include: A final attempt was made on 10/6/2022 at 3:00 PM., to review the agency's QAPI program for 2020, 2021 and 2022 to date after an initial notification on 10/5/22 at 4:30 PM. Previous requests on 10/6/22 were also noted at 9:45 AM and 11:50 AM. Documentation that showed the agency had collected and utilized data used to substantiate an active and ongoing QAPI program were not evidenced by the survey's conclusion on 10/6/22 at 3:00 PM. During an interview on 10/6/22 at 2:40 PM., the Administrator acknowledged the above findings and its Governing Body failed to ensure measures were in place to readily evaluate the QAPI program from 2020 through the survey's exit date of 10/6/22.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure effective infection prevention and control measures were utilized (G-682); failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases that was incorporated into the Quality Assessment/Performance Improvement program (G-684); failed to provide documented evidence that infection control education was provided to all staff employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection (G-686); and failed to provide documented evidence to support that all staff employed by this agency and those who had been granted clinical privileges, had been vaccinated against the Covid-19 virus (G-687). The cumulative effect of these systemic problems resulted in the agency's inability to prevent the development and spread of infections to staff members and patients currently serviced by this agency.

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, interview and record review, the Agency failed to ensure the Skilled Nurse utilized Infection Control standards of practice during the provision of care and services for 1 (MR #2) patient observed during a home visit, who required wound care, from a total of 17 sampled records reviewed, resulting in the potential for the development and spread of infection. Findings include: MR #2: The patient's start of care was 9/16/22 with diagnoses that included Cancer of Uterus and Fallopian Tube with subsequent colostomy and urostomy placement. On 10/3/22 at 2:00 p.m. a schedule home visit was conducted with the registered Nurse (RN #1). During the visit, the following was observed: The patient had a midline postoperative abdominal incision with 13 staples present. The lower portion of the wound had opened (dehisced) and required wound care and dressing changes. After preparing a clean field for dressing supplies, RN #1 proceeded to cleanse the patient's wound with wound cleanser and wiped it with gauze. RN #1 changed her gloves, donned a clean pair of gloves, and proceeded to dress the wound as ordered. Upon completion of wound care, RN #1 discarded the remaining wound care supplies in a nearby trash bag. While wearing the same gloves, RN #1 searched for an ink pen in her upper and lower uniform pockets by patting her pockets until she located an ink pen. After completing her documentation, still wearing the same gloves, RN #1 then removed her gloves and sanitized her hands. RN #1 failed to utilized Infection Control standards of practice during the provision of care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:37 p.m.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases. The agency also failed to incorporate an infection control program into the Quality Assessment/Performance Improvement program, resulting in the potential spread of infections between patient care staff and all agency patients. Findings include: On 10/6/22 at 8:30 a.m., the administrator was asked to provide the survey team with the agency's Infection Control (I/C) program. The agency was asked again for the I/C program at 11:45 a.m. A third request was made with the administrator at 2:00 p.m. At the time of survey exit from the agency on 10/6/22 at 3:45 p.m., No I/C information had been provided to the surveyors.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review, and interview, it was determined the Agency (HHA) failed to provide documented evidence that infection control education was provided to all staff employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection. Findings include: On 10/6/22 at 8:30 a.m., the administrator was asked to provide the survey team with the agency's Infection Control (I/C) program. The agency was asked again for the I/C program at 11:45 a.m. A third request was made with the administrator at 2:00 p.m. Throughout the survey, personnel files were requested for review for I/C education and training, and the I/C program was requested for review. At the time of survey exit from the agency on 10/6/22 at 3:45 p.m., No personnel files or I/C information had been provided to the surveyors for review.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to provide documented evidence to support that all staff employed by this Agency and those who had been granted clinical privileges, had been vaccinated against the Covid-19 virus, resulting in the potential for the development and spread of Covid-19 to staff and all 3,140 patients currently serviced by this Agency. Findings include: On 10/4/22, upon review of the Agency's Vaccine policy, it was noted that the requirements of this section had not been met. Upon review of the Agency's Vaccine Policy, it was noted that there was no contingency plan put in to place for all staff who had not been vaccinated and/or who had been granted an exemption. There was no process put into place for tracking those individuals who were exempt and had not been vaccinated. There was no process for the implementation of additional precautions for all staff who had not been vaccinated fully or in part. Additionally, multiple requests were made verbally and via email, on 10/3/22, 10/4/22, 10/5/22 and 10/6/22, to view staff's vaccination cards along with exemption letters for all staff who were granted waivers. After multiple requests no documented evidence had been provided of staff's vaccination status by the end of the survey. These findings were reviewed with the Administrator (Adm #1) during the Exit Interview on 10/6/22.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Physical Therapist (PT) followed accepted standards of practice in assuming responsibility for the care of 1 (MR #16) of 1 patient with therapy only services who required heart failure management (See G704); failed to ensure the Skilled Nurse performed baseline assessments and reassessments, including monitoring patient's weight and measurable assessments of edema for 2 (MR's #1, 4) patients who required ongoing monitoring, from a total of 17 sampled records reviewed, resulting in the potential for physiological decline, untreated health concerns and unmet care needs (See G706); failed to ensure PT evaluated and developed a plan of care within the Agency standard of 5 days for 1 (MR #13) of 16 records with PT services (See G708); failed to ensure that Skilled Nursing (SN) services were administered in accordance with the Physician's orders and the plan of care in 1 (MR #17) of 1 record with required catheter changes (See G710); failed to provide education/safety instructions in 1 (MR# 12) of 1 patient on oxygen with nicotine dependence and failed to ensure the patient and caregiver were provided education/instructions in 1 (MR #15) of 2 patients requiring wound care (See G 714); and failed to provide LPN supervision by the registered nurse in 1 (MR #3) of 4 records reviewed with LPN services ordered (See G726). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.75 Skilled Professional Services.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on document review and interview, the Agency failed to ensure the needs of the patient were met in 1 (MR #16) of 1 record reviewed with heart failure and therapy only services ordered from a total sample of 17 records reviewed, resulting in the potential for physical harm to the patient. Findings included: MR#16: The start of care (SOC) date was 9/8/2022 with diagnoses that included congestive heart failure, chronic kidney disease, and anemia. On 10/5/22, record review of the referral for home care noted the following instructions to the patient concerning discharge from the hospital on 9/7/22: "Your primary diagnosis was: Acute diastolic CHF (congestive heart failure) ...Acute respiratory failure with hypoxia (low oxygen in the blood). Contact your doctor if: you gain 2-3 pounds in one day or 5 pounds in 5 days, you have increased swelling in your hands, feet or stomach." Further review noted the physical therapist (PT#2) performed the SOC initial comprehensive assessment on 9/8/22 and documented the patient's weight as 147 pounds with edema (swelling) of the lower right and left extremities. No degree or severity of the edema was found within the assessment or clinical record. Review of the patient's plan of care (POC) dated 9/8/22, ordered weekly PT visits times 7 weeks. The patient's POC had no means to monitor (i.e., weight, body circumference measurements, levels of edema) the patient's primary diagnosis of CHF. Parameters in which to notify the physician in the event the patient experienced exacerbation (worsening) of heart failure symptoms, were not evidenced. In addition, 3 of 3 PT home visits after the SOC from 9/16/22 through 9/29/22, had failed to document any weights or oxygen saturation levels. No heart or edema assessments were found in all 3 PT home visit clinical notes. During an interview with the Administrator and Director of Nursing on 10/6/22 at 11:30, it was acknowledged by both that any patient with a primary diagnosis of CHF would require the Agency's "CHF Pathways" to be instituted to effectively monitor and manage the heart failure needs of the patient above. Both agreed this was not done and did not meet Agency expectations.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the Agency failed to ensure the Skilled Nurse performed baseline assessments and reassessments, including monitoring patient's weight and measurable assessments of edema for 2 (MR's #1, 4) patients who required ongoing monitoring, from a total of 17 sampled records reviewed, resulting in the potential for physiological decline, untreated health concerns and unmet care needs. Findings include: Policy: Initial and comprehensive Assessment QA-011 HH, 7/14/21 stated, "At a minimum, and in collaboration with the patient/ patient representative the patient will be assessed: a physical assessment including blood pressure, temperature, pulse, respiration, skin, pain status, actual height/ weight..." MR #1: The patient's start of care (SOC) was 8/19/22 with diagnoses that included Cervicalgia, Spinal Stenosis and Hypertension. On 10/3/22 at 12:45 p.m., a scheduled joint home visit was conducted with the Licensed Practical Nurse (LPN #1). During the visit, it was noted that the patient had bilateral lower extremity edema. LPN #1 assessed the patient's legs and reported, "Well, they're not better or worse that the last time I saw you." LPN #1 then concluded the examination without measuring the patient's legs. LPN #1 failed to accurately assess the patient's swelling. On 10/4/22 at 12:40 p.m., during the review of the clinical record/Nurse Visit Notes, it was noted that the patient had swelling to her lower extremities on 8/23/22, 8/31/22, 9/8/22, 9/15/22 and 9/28/22. All the aforementioned visit notes were void of any objective measurements of edema. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/4/22 at 4:19 p.m. MR #4: The patient's SOC was 4/14/22 with diagnoses that included Hypertensive Heart disease with Heart Failure, Congestive Heart Failure (CHF) and Diabetes Mellitus. During the clinical record review on 10/5/22 at 9:30 a.m., it was noted that the patient had a baseline weight of 178 pounds (lbs.). It was not clear if this was an actual or stated weight. There was no assessment of edema. The patient was transferred to an inpatient facility on 4/17/22 due to complications of CHF and resumed services with the Agency on 5/14/22 at which time the skilled nurse documented a baseline weight of 196 lbs. Again, it was unclear as to whether this was an actual or reported weight. The Resumption of Care (ROC) assessment dated 5/14/22 revealed that the patient had bilateral lower extremity edema, however, there were no associated measurements. The visit notes from 5/14/22 to 6/12/22 were reviewed and revealed: 5/16/22 196 lbs., 5/18/22 196 lbs. positive edema/no measurements, 5/20/22 no weights obtained, positive edema/no measurements, 5/23/22 no weight obtained, positive edema/no measurements, 5/25/22 no weight or assessment of edema, 5/27/22 no weight obtained or assessment of edema. On 5/28/22, the Certified Occupation Therapy Assistant (COTA) documented the patient's weight at 210 lbs. On 6/4/22, the patient's weight reflected 196 lbs. On 6/8/22, the Physical Therapist documented the patient complaint of left leg heaviness and swelling. There was no other documentation regarding the Therapist's observations. Further review of the clinical record revealed a visit note dated 5/17/22 which stated, "Patient not weighing herself daily - doesn't have a scale." The Agency failed to ensure that the patient's health status was continually assessed throughout the course of care. Additionally, there was no evidence to support that the documented weights were authentic and reflected the patient's actual weights during the above dates. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/5/22 at 1:57 p.m. When queried about the patient's weights being carried over within the visit notes, reflecting 196 lbs., Adm #1 reported, "This just identifies areas for us to improve."

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Physical Therapist (PT) evaluated and developed a plan of care within the Agency standard of 5 days for 1 (MR #13) of 16 records in which PT services were ordered, from a total sample of 17 records reviewed, resulting in the potential for decline in physical functioning. Findings include: MR#13: The start of care (SOC) date was 9/16/2022, with a diagnoses history that included coronary artery disease, chronic obstructive pulmonary disease and diabetes-type 2. During record review on 10/5/22, it was noted that the 9/16/22 plan of care ordered PT services to evaluate and treat the patient. The PT documented an evaluation of this patient on 9/23/22, which was 7 days after the SOC. During record review on 10/5/22, it was noted that there was no documented evidence the patient or caregiver had delayed PT services and no documentation that the physician was informed of the delay in PT services. During the entrance conference on 10/3/22, the Director of Nursing explained that add-on disciplines are to evaluate and treat the patient within 5 days from when the order was received. During an interview on 10/6/22 at 10:42 AM., the Administrator and Director of Nursing had acknowledged and agreed with the above finding.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that Skilled Nursing (SN) services were administered in accordance with the physician's orders on the plan of care in 1 (MR #17) of 1 record which required catheter changes, resulting in the potential for unmet patient needs and poor outcomes. Findings include: MR #17: The patient had a start of care (SOC) date of 8/26/22, with diagnoses that included pressure ulcer of sacral region-stage 3, hypothyroidism, and pulmonary hypertension. Review of the patient's plan of care (POC) noted the following order: "Skilled nurse for catheter maintenance with catheter #16 FR (size), 10 cc balloon, change monthly and prn (as needed) dislodgement or stoppage, and obtain urine specimen as indicated." Review of the referral for home care (dated 8/24/22) revealed the following physician documentation: "Pt (patient) is currently at Medilodge, states the care is grossly inadequate, wants to go home." No information was found on the referral concerning the date the patient's catheter was last changed as to prevent urinary infection. Further review of the record noted POC orders for SN to provide visits 1W1 (once a week for 1 week), 2W1, and 1W7. Additional review found from the SOC visit on 8/26/22 through date of survey exit on 10/6/22, no documentation was found of SN changing the patient's urinary catheter as ordered. Also, no SN visits were made after 9/22/22 which were verified on 10/4/22 by the Administrator as a missed SN visit. The Administrator and Director of Nursing confirmed the above findings during an interview on 10/6/22 at 11:38 AM. The Administrator was observed at 11:39 AM. scheduling a SN visit that day.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the Agency failed to provide education/safety instructions in 1 (MR# 12) of 1 patient on oxygen with nicotine dependence and failed to ensure the patient and caregiver were provided education/instructions in 1 (MR #15) of 2 patients requiring wound care; resulting in the potential for unmet patient care needs and a poor clinical outcome. MR#12: This patient's start of care (SOC) was 6/10/22, with diagnoses that included congestive heart failure, chronic kidney disease and anemia. On 10/5/22, record review noted the patient's plan of care (POC) and resumption of care (ROC) dated 6/10/22 and 7/18/22 respectively, had documented the patient's diagnoses as, "Dependence on supplemental oxygen" and "Personal history of nicotine dependence". Review of the POC and ROC found no evidence of educating the patient concerning the dangers of nicotine dependence/smoking with concurrent use of oxygen. In addition, no goals or interventions were found in the medical record concerning this finding. During an interview on 10/6/22 at 10:24 AM., the Administrator and Director of Nursing acknowledged the above findings. MR#15: The SOC for this patient was 7/15/22, with diagnoses that included pulmonary embolism (blockage of a lung artery), pressure ulcer of right heel-stage 3, and hypertension. During a joint home visit with occupational services on 10/4/22, it was observed the patient had active drainage from the right heel. The patient was queried how satisfied she was with the services received from the home care agency. The patient stated, "Everyone has been great except for the nurse." When asked to further explain, the patient noted two main issues. One, the nurse never explained or instructed her or her caregiver on how to change the right heel dressing on the days when the nurse was not scheduled to make a home visit. Second, the patient felt there was little to no education on what the nursing visit schedule was going to be in the upcoming days/weeks. Review of the clinical record found no evidence that documented the caregiver or patient had successfully verbally and physically demonstrated a complete and successful dressing change before handing off the responsibility to the patient/caregiver. Further, the patient calendar used to inform/educate the patient of upcoming visits was found to be blank since admission on 7/15/22. During an interview on 10/6/22 at 11:09 AM., the Administrator and Director of Nursing acknowledged the above findings.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Registered Nurse failed to supervise the services provided by the Licensed Practical Nurse (LPN) for 1 (MR#12) of 4 records reviewed with LPN services out of a total sample of 14 records reviewed with nursing services, resulting in failure of the LPN to provide services as ordered by the physician and unmet patient care needs. Findings include: MR#12: This patient was admitted to the agency on 6/10/22 with diagnoses that included congestive heart failure, chronic kidney disease and anemia. The plan of care (dated 6/10/22) ordered Skilled Nursing (SN) with a visit frequency of 1WK1 (once a week for one week), 3WK2, 2WK2, and 1WK4. On 10/5/22, review of the clinical record noted 7 of 7 LPN visits furnished on 6/14/22 through 7/8/22 had no evidence of LPN supervision ever being performed by the Registered Nurse. In addition, record review found an RN supervisory note dated 6/18/22 which documented review of the LPN was not applicable due to no LPN visits made within the last 2 weeks. However, the clinical record documented LPN visits were provided on 6/14/22 and 6/17/22. During an interview on 10/6/22 at 10:30 AM., the Administrator and Director of Nursing confirmed the above findings and reiterated this failed to meet agency expectations that an RN should perform a review of LPN documentation at least every 30 days.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on interview, the Agency failed to provide documented evidence to support that 3 of 3 Home Health Aides employed by this Agency were trained, qualified and deemed competent to provide care and services to the Agency's patient population in accordance with this requirement, resulting in the potential for the rendering of unsafe care (G768); failed to ensure the Registered Nurse (RN) prepared complete written instructions for patient safety needs in 5 (MR#'s 9, 13, 15, 4, 5) of 6 records in which aide services were provided, from a total of 17 records reviewed, resulting in the potential for unsafe, substandard care and unmet care needs (G798). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.80 Home Health Aide Services.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on interview, the Agency failed to provide documented evidence to support that 3 of 3 Home Health Aides employed by this Agency were trained, qualified and deemed competent to provide care and services to the Agency's patient population in accordance with this requirement, resulting in the potential for the rendering of unsafe care. Findings include: On 10/5/22 and again on 10/6/22, multiple requests were made to review the Agency's employee files, including all Home Health Aide files in order to determine if the Aides employed by this Agency had been deemed competent to provide care and services. The Administrator repeatedly replied, "I'm working on it." No evidence of Home Health Aide training, competencies or qualifications had been provided by the end of the survey on 10/6/22 at 3:30 p.m.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure the Registered Nurse (RN) prepared complete written instructions for patient safety needs in 5 (MR#'s 9, 13, 15, 4, 5) of 6 records in which aide services were provided, from a total of 17 records reviewed, resulting in the potential for unsafe, substandard care and unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 4/14/22 with diagnoses that included Hypertensive Heart disease, Congestive Heart Failure and Diabetes Mellitus. The plan of care (POC) ordered the patient to receive Home Health Aide (HHa) services at a frequency of 2x/wk. x 2 wks. and indicated the following equipment and Safety Precautions: Commode, Shower/Tub equipment, Walker, incontinence, cardiac compromise, vision impaired, weakness/fatigue, Dementia, Diabetic Precautions, Fall Precautions, Assist with Transfers. The "Aide Care Plan Report" was void of any of the aforementioned safety precautions and equipment. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/5/22 1:36 p.m. MR #5: The patient's SOC was 10/1/22 with diagnoses that included Hypertensive Heart disease and Congestive Heart Failure. The POC ordered HHa services to be provided at a frequency of 1x/wk. x 2 wks. and indicated the following equipment and Safety Precautions: Cardiac compromise, Weakness/Fatigue, Diabetic precautions, Fall precautions, Pacemaker precautions, Cane, Walker. The Aide Care Plan Report was void of any of the aforementioned safety precautions and equipment. These findings were reviewed with and acknowledged by Adm #1 during an interview on 10/6/22 at 9:07 a.m. MR #9: The patient's SOC was 8/26/22, with diagnoses that included diabetes, Alzheimer's, and heart failure. The POC, reviewed on 10/5/22, ordered HHa services. During review of HHa care plan, it was discovered that no safety precautions were documented for HHa to be aware of while providing services. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. MR#13: The start of care (SOC) date was 9/16/2022 with a diagnoses history that included coronary artery disease, chronic obstructive pulmonary disease and diabetes-type2. The plan of care (POC) dated 9/16/22 ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHa) services. The POC specified functional limitations of endurance and ambulation. Safety measures were adaptive equipment precautions, ambulation safety, anticoagulation (bleeding) precautions, emergency/evacuation plan, fall precautions, full code, medication precautions, and universal precautions. The HHa care plan dated 9/16/22 failed to include the above functional limitations and safety precautions to ensure the safety of the patient while the aide was providing care. The findings were reviewed with and acknowledged by the Administrator and Director of Nursing during an interview on 10/6/22 at 10:42 AM. MR#15: The SOC date was 7/15/2022 and re-certified on 9/13/22, with diagnoses that included pressure ulcer of right heel-stage 3, hypertension, and drug-induced polyneuropathy (peripheral nerve damage). The re-certification POC dated 9/13/22 ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHa) services. The POC specified functional limitations of endurance and ambulation. Safety measures were adaptive equipment precautions, ambulation safety, clear pathways, emergency/evacuation plan, fall precautions, medication precautions, pressure relieving measures, urostomy and universal precautions. The HHa care plan effective 9/13/22 failed to include the above functional limitations and safety precautions to ensure the safety of the patient while the aide was providing care. The findings were reviewed with and acknowledged by the Administrator and Director of Nursing during an interview on 10/6/22 at 11:10 AM.

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 observation, record review and interview, the Registered Nurse failed to accurately document findings obtained during a wound assessment for 1 (MR #2) patient observed during a home visit who required care of a surgical wound, from a total of 17 sampled patients reviewed, resulting in an inconsistent inaccurate clinical record designed to aid the Physician in determining the continuing care needs of the patient, the potential for the rendering of unneeded services and treatments, and overall unmet care needs. Findings include: Policy: Documentation of Clinical Services CL-004 8/18/21 stated, "Documentation in the clinical/service record will be timely, detailed, accurate, and reflect the care or services provided..." MR #2: The patient's start of care was 9/16/22 with diagnoses that included Cancer of Uterus and Fallopian Tube with Colostomy, and Urostomy placement. On 10/3/22 at 2:00 p.m., a scheduled joint home visit was conducted with the Registered Nurse (RN #1). During the visit, RN #1 performed a dressing change to the patient's lower midline surgical site. Prior to the visit, RN #1 informed this writer that the lower portion of the patient's surgical site had dehisced (opened up) and required dressing changes. during the procedure, RN #1 removed the old dressing and measured the length (L), width (W) and depth (D) of the opening which she (RN #1) measured: L-7cm (centimeters), W-2.6 cm, D-2.0 cm. Again, prior to the procedure, RN #1 was asked to state the measurements aloud for this writer. Direct observations were made as RN #1 assessed the wound measurements. On 10/4/22 at 2:11 p.m., the clinical record review revealed the following "LENGTHxWIDTHxDEPTH(CM)" measurements as documented by the Skilled Nurse: (9/23/22) L7.3 cm x W2.5 cm x D1.3 cm; (9/27/22) L7.2 cm x W3.5 cm x D1.3 cm; 10/3/22 (date of home visit) L9.0 cm x W2.0 cm x D2.6 cm. RN #1 entered inaccurate measurements in the patient's clinical record as these were not the wound measurements obtained during the home visit. RN # failed to ensure the clinical record accurately reflected the patient's wound status. These findings were reviewed with and acknowledged by the Administrator (Adm #1) who reported, "RN #1 should have documented correctly based on the actual assessment of the wound."

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a transfer summary was completed and sent to the physician/receiving facility within 2 business days of the patient's transfer for 2 (MR #12, 4,) of 2 records in which the patient was transferred to an inpatient facility; and failed to ensure a discharge summary was completed for 2 (MR #4, 6) patient who was discharged from the Agency's services, from a total of 17 sampled records reviewed, resulting in the physician/receiving facility not having knowledge of the patient's health status at the time of transfer and the potential for unmet post-transfer needs. Findings include: MR#12: This patient was admitted to the agency on 6/10/22 with diagnoses that included congestive heart failure, chronic kidney disease and anemia. On 10/5/22, review of the clinical record noted an Occupational Therapy coordination note that documented the patient was transferred to the hospital on 7/9/22. Further review of the record found no evidence of a transfer summary. Subsequently, no evidence that a transfer summary was sent to the receiving facility/physician within 2 business days of the patient's transfer was found. These findings were reviewed with and confirmed by the Administrator and Director of Nursing during an interview on 10/6/22 10:35 AM. MR #6: The patient's SOC was 5/19/2020, with diagnoses that included heart disease, chronic kidney disease, heart failure and diabetes. During record review on 10/3/22, it was discovered that no discharge summary was documented. There was a discharge summary report in the record that did not summarize the patient's care. There was no evidence in the record that a discharge summary was sent to the physician for review. During an interview on 10/6/22 at 2:35 p.m., the administrator (Adm #1) and the director of nursing (DON#1) acknowledged the above findings. Policy: Discharge Summary CL-005 9/1/21 stated, "A summary of the care or services provided..., Each discipline who provides care will complete a discharge summary at the time of his/her discharge which may include as appropriate: The date of discharge and disposition at discharge, The reason for discharge including, if applicable, the name of the organization to which the patient is being transferred, the status of outcomes/goals identified at admission and during the provision of care, The resolution of outcomes/goals, Continuing symptom management needs, The overall status of the patient, A copy of the discharge summary will be provided to the patient’s physician within 5 business days..." A policy was requested regarding the Agency's Transfer process but was not provided at the time of this survey. MR #4: The patient's start of care (SOC) was 4/14/22 with diagnoses that included Hypertensive Heart Disease, Congestive Heart Failure (CHF) and Diabetes Mellitus. During the record review on 10/5/22 at 9:30 a.m., it was noted that the patient was ordered to receive Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Home Health Aide (HHa) and Medical Social Work (MSW) services to be provided. The review revealed that the patient had been transferred to the hospital and admitted due to complications of CHF. It was further noted that no transfer summary had been completed and forwarded to the receiving facility or the Physician as per this requirement. Further review revealed that the patient ended Occupational Therapy services on 6/4/22 and was recertified for an additional episode of care to begin on 6/13/22. A note dated 6/12/22, documented that the patient declined further OT services. At the time of this review, no OT discharge summary had been completed prior to, or after the patient had been recertified. The above findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 10/5/22 at 1:36 p.m.

Personnel qualifications CFR(s): 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: This CONDITION is not met as evidenced by: Based on interview and document review, the Agency failed to provide documented evidence of staff qualifications to practice as skilled professionals in the State of Michigan and be granted clinical privileges for 240 staff employed by this Agency, including contracted employees, resulting in the potential for non-regulated unsafe health practices. The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.115 Personnel Qualifications. Findings include: On 10/5/22 and 10/6/22, the Agency's Administrator was asked for permission to review the Agency staff's files to ensure staff were appropriately licensed to practice care in the State of Michigan. Also requested, was evidence of staff evaluations and trainings in policies and procedures. By the end of the survey on 10/6/22 at 3:30 p.m., the Administrator had not provided the documents as requested. The Agency failed to provide documentation of staff qualifications to provide care in the State of Michigan.

An unannounced on-site complaint investigation for federally authorized complaint #MI0031908 was conducted on 9/24/21 at: Beaumont Home Health 1975 Technology Dr., Suite J120 Troy, MI 48083 The agency has no branch sites. For this survey, 5 records were reviewed without home visits. The allegations were substantiated. A Condition level deficiency was identified at: 42 CFR §484.60 Care planning, Coordination of Services, and Quality of care The Administrator was informed that as a result of the Condition level noncompliance on 9/24/21, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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 record review and interview, it was determined that the Agency failed to provide care and services in accordance with the plan of care in 5 (MR's # 1, 2, 3, 4, and 5) of 5 records reviewed for provision of services, resulting in the potential for decline in physical functioning and unmet care needs (See G572). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60 Care Planning, Coordination, Quality of Care.

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, it was determined that the Agency failed to provide care and services in accordance with the plan of care in 5 (MR's # 1, 2, 3, 4, and 5) of 5 records reviewed for provision of services, resulting in the potential for decline in physical functioning and unmet care needs. Findings include: Policy: "Coordination of Services 03-003" 12-06-19 stated, "Purpose: To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. 5.0 When the patient requires more than one (1) service from the organization, the agency is responsible for coordinating care planning in order to assure that goals, actions, and the interrelationship of services are not duplicated and to minimize the potential for missed or conflicting services." MR#1: The Start of Care (SOC) was dated 7/20/21. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Atrial Fibrillation and Hypertension. The POC dated 7/20/21 contained an order for Skilled Nursing (SN) at a frequency of 3w2 (3 times a week for 2 weeks), 2w1, 1w6. Physical Therapy (PT) was ordered at a frequency effective 7/25/21 of 2w2, 1w4, then effective 9/12/21 2w1. Additionally, Home Health Aide was ordered at a frequency of 1w1, 2w1, 1w1, then effective 8/12/21: visit 8/13/21, then effective 8/15/21: 2w2, and then effective 9/5/21: 2w2. During record review on 9/24/21, it was noted that Staff-D documented a missed visit on 8/2/21 stating, “Date of missed visit: 7/31/21. Discipline of missed visit: LPN. Patient driven reason for missed visit: left blank.” Furthermore, Staff-C documented on 8/17/21, “Date of missed visit: 7/23/21. Discipline of missed visit: LPN (Licensed Practical Nurse). Patient driven reason for missed visit: Unable to coordinate care.” Additionally, on 8/17/21, Staff-C documented, “Date of missed visit: 7/29/21, 8/2/21, 8/5/21. Discipline of missed visit: PT. Patient driven reason for missed visit: Unable to coordinate care.” Furthermore, Staff-C documented on 8/17/21, “Date of missed visit: 7/23/21, 7/27/21, 7/29/21. Discipline of missed visit: HH (Home Health Aide). Patient driven reason for missed visit: Unable to coordinate care.” Additionally, on 8/27/21 Staff-H documented a missed visit stating, “Patient was given a shower yesterday and patient has a lot of appointments today and is too tired for a shower today.” Of the ordered 13 Home Health Aide visits, 6 were completed, 4 had missed visit documentation, and 3 had no documentation of a completed visit. The agency failed to provide services at the ordered frequency and to attempt to reschedule the missed visits to meet the ordered POC. MR#2: The Start of Care (SOC) was dated 8/30/21. The Plan of Care (POC) identified diagnoses of Gastrointestinal Hemorrhage and Chronic Kidney Disease. The POC dated 8/30/21 contained an order for SN at a frequency of 1w1, 2w1, 1w7. During complaint record review on 9/24/21, it was noted that the agency received a complaint on 9/9/21 stating, “My mother, MR#2, was d/c from the hospital on 8/28/21. She had HHC (Home Health Care) ordered for nurse, PT and OT. PT and OT did follow thru and have been coming to her home for PT/OT. The HHC nurse never showed up. We called Beaumont HHC agency and they told us they were short staffed. 3X, no call no show…” (sic). On 9/14/21, Staff-E documented a follow-up comment on the “Complaint Report” stating, “Staff-F spoke with daughter who stated they have been very upset with nursing due to not receiving a call back when DON (director of nursing) asked specifically who they called the daughter stated they called the main line and asked to speak to scheduling 3 times and left a message 3 times and did not receive a call back. Daughter stated the last time they left message for scheduling they called back same day and asked for clinical manager. They left message for manager and received a call back that evening. Daughter stated when she spoke to manager, manager told her that “they are still trying to find a nurse for this evening” daughter told manager she did not want a nurse in the evening and was willing to wait until Tuesday to receive a nurse for this week. Manager let her know she would make sure patient got a call Sunday or Monday night with a time for Tuesday. Daughter stated nurse did not call as agreed upon with the clinical manager…” (sic). A clinical note dated 9/2/21 stated, “RN (Registered Nurse) spoke with daughter, per daughter request wants a nursing visit Friday morning.” A missed visit was documented on Friday, 9/3/21 at 11:14 am by Staff-G stating, “Date of missed visit: 9/3. Discipline of missed visit: RN. Patient driven reason for missed visit: Unable to coordinate care.” An ordered was documented on 9/8/21 stating, “Patient/Family requesting to discontinue skilled nursing services only at this time and to continue with Physical Therapy.” This was one day after the “Complaint Report” noted the agreed upon skilled nursing visit for Tuesday, 9/7/21, and not receiving a phone call Sunday or Monday night with a time for skilled nursing. The agency failed to provide services at the ordered frequency and to attempt to reschedule the missed visits to meet the ordered POC. MR#3: The Start of Care (SOC) was dated 7/10/21. The Plan of Care (POC) identified diagnoses of Alzheimer’s and Dementia. The POC dated 8/30/21 contained an order for SN at a frequency of 1w1, 2w1, 1w7. During record review on 9/24/21, it was noted that Staff-I documented, “Date of missed visit: 7.16.21. Discipline of missed visit: Nurse. Patient driven reason for missed visit: Unable to coordinate care.” The agency failed to provide services at the ordered frequency and to attempt to reschedule the missed visits to meet the ordered POC. MR#4: The Start of Care (SOC) was dated 9/10/21. The Plan of Care (POC) identified diagnoses of Cerebral Infarction and Hypertension. The POC dated 9/10/21 contained an order for SN at a frequency of 1w1, 2w2, 1w6. During record review on 9/24/21, this surveyor observed Staff-J calling this patient at 1:55 pm and stating, “There is a nurse visit scheduled for today, but I do not have anyone to send out...” On 9/24/21 at 1:57 pm, Staff-J documented, “Date of missed visit: 9/24/21. Discipline of missed visit: LPN. Patient driven reason for missed visit: Called patient, okay to miss this visit.” The agency failed to provide services at the ordered frequency and to attempt to reschedule the missed visits to meet the ordered POC. MR#5: The Start of Care (SOC) was dated 8/20/21. The Plan of Care (POC) identified diagnoses of Abscess of the Breast and Nipple and Congestive Heart Failure (CHF). The POC dated 9/10/21 contained an order for SN at a frequency of 1w1, 2w4, 1w3, 2w1. During record review on 9/24/21, it was noted that Staff-K documented on 8/28/21, “Date of missed visit: 8/27/21. Discipline of missed visit: SN Patient driven reason for missed visit: Client exhausted at the time of visit. Client prefers a visit Saturday/Today.” There was no documentation of a completed SN visit on Saturday, 8/28/21. Furthermore, on 9/4/21 Staff-K documented, “Date of missed visit: blank. Discipline of missed visit: SN. Patient driven reason for missed visit: Writer was off work Tuesday, Wednesday, Thursday.” Additionally, on 9/10/21 Staff-K documented, “Date of missed visit: 9/10/21. Discipline of missed visit: SN. Patient driven reason for missed visit: Doctor appointment.” The agency failed to provide services at the ordered frequency and to attempt to reschedule the missed visits to meet the ordered POC. Additionally, this surveyor heard Staff-J make numerous phone calls regarding nursing visits. Examples include at 12:13 pm on 9/24/21 Staff-J stated, “You are scheduled for a nursing visit today, but we are having difficulties finding a nurse and wondering if it would be ok for a missed visit and the nurse would come out next week?” At 12:18 pm on 9/24/21 Staff-J stated, “The nurse is supposed to come out and discharge today, do you think you need the nurse to come out for that visit or if they could do a phone discharge?” At 1:15 pm on 9/24/21 Staff-J stated, “You are scheduled for a nursing visit today and we do not have a nurse available. How is your wound doing? Ok, we will see you next week for your nursing visit then.”