Every finding on record at Fox Run Home Health Agency

A Medicare authorized Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/13/25 through 5/16/25 at: Fox Run Home Health Agency 41100 Fox Run Road Novi, MI 48377 This agency did not have any additional branch locations. At the conclusion of the survey, the agency was found to be out of compliance with the Conditions of Participation at 42 CFR 484.102 Emergency Preparedness.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure an Emergency Preparedness Plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency. Findings include: On 5/14/25 at 11:18 a.m., the agency's Emergency Preparedness documents were reviewed with the Security Manager (SM#1) and joined by the Assistant Security Manager (ASM #1). During the interview, SM #1 was queried as to how the Emergency Plan was developed and what it was based on and reported, "The plan is based on our corporate initiatives. We have a template, and we make changes as best practices apply." When asked for permission to review the agency's documented Risk Assessment that drives the course of the Emergency Preparedness Plan and Policies, SM #1 was initially unfamiliar with the requested document. After searching, SM #1 stated, "I think I know what you're talking about, but it's in another book. Upon review of the presented documents, it was noted that the Risk Assessment had zeros (zero likelihood of occurrence) in areas such as active shooter, flooding, bomb threat. Upon further review, though documented as zero probability, there were documented strategies to address the aforementioned potential hazards. The agency's Emergency Preparedness plan did not align with the agency's Risk Assessment. The agency failed to ensure the Emergency Preparedness Plan was based on a documented Risk Assessment from an all-hazards approach. These findings were reviewed with and acknowledged by SM #1 at the time of discovery and again with the Administrator and Clinical Manager during the exit interview on 5/16/25.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and establish written Emergency Preparedness policies and procedures that were based on the Emergency Preparedness plan, risk assessment and communication plan that had been updated every 2 years, resulting in the agency’s inability to implement appropriate emergency actions and the potential for poor outcomes for all staff and patients services by this agency in the event of a disaster. Findings include: On 5/14/25 at 11:18 a.m., during a review of the agency’s Emergency Preparedness documents with the Security Manager (SM #1), it was noted that the Emergency Preparedness policy had not been updated since 2021. During the interview, SM #1 looked through his laptop and reported, "There is a notation that states the policy is due to be reviewed in May of this year, so they will review it then." The agency failed to ensure its Emergency Preparedness policies and procedures had been updated at least every 2 years as per this requirement. These findings were reviewed with and acknowledged by SM #1 at the time of discovery and with the Administrator and Clinical Manager during the exit interview on 5/16/25.

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, the Agency failed to incorporate an individualized Emergency Preparedness Plan into the Comprehensive Patient Assessment for 7 (P-1, P-2, P-3, P-4, P-5, P-6, P-7) records of patients who required individualized assessments in Emergency Preparedness from a total of 7 sampled records reviewed, resulting in the potential for overlooked patient needs in the event of an actual emergency for all patients services by this Agency. Findings include: P-1: The patient's start of care (SOC) was 4/22/25 with diagnoses that included Wedge Compression Fracture T11-T12 Vertebra. During the clinical record review on 5/13/25 at 12:45 p.m., it was noted that the patient's in-home Emergency Preparedness (EP) evaluation was not individualized to address the needs of the patient in the event of a disaster. There was no mention of the patient's fall risk or the need for use of assistive devices. P-2: The patient's SOC was 5/6/25 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Congestive Heart Failure, Dilated Cardiomyopathy and Head Injury. During the record review on 5/13/25 at 1:50 p.m., it was noted that the patient's EP evaluation was not individualized to address the needs of the patient in the event of a disaster. The sections that addressed the patient's needs in a disaster titled, "Category I: Must be seen; Category II: Should be seen; Category III: No immediate need" were all left blank. The Plan of Care (POC) revealed the patient required the use of assistive devices, was a falls risk and was incontinent. The assessment was void of any of the patient's needs. P-3: The patient's SOC was 5/2/25 with diagnoses that included Multiple Rib Fractures, Dementia, anxiety, Vertigo and Brain Injury. During a review of the patient's EP assessment on 5/14/25, it was noted that there was no documented assessment of the patient's needs in the event of an emergency or disaster. The POC revealed the patient required the use of assistive devices and was a falls risk. Further, the patient was on seizure precautions. The aforementioned needs were not included in the patient's EP assessment. P-4: The patient's SOC was 5/1/25 with diagnoses that included Myasthenia Gravis (progressive muscular disorder), Atrial Fibrillation and Left Shoulder Reverse Arthroplasty. During a review of the patient's in-home EP assessment, it was noted that there was no assessment of the patient's needs that would guide emergency personnel in the event of a disaster. the POC indicated the patient required the use of assistive devices and had bleeding precautions. These needs were not included in the patient's assessment. The above findings were reviewed with and acknowledged by the Administrator and Clinical Manager during the exit interview on 5/16/25. P-5: The patient was admitted to the home care Agency on 3/21/25, with diagnoses which included disruption of surgical wound, status-post pulmonary embolism, and hypertensive heart disease. On 5/13/25, a record review of the patient's individualized emergency plan revealed no specific aspects of concern that would be considered in the event of an emergency that would involve P-5. In addition, documentation of a triage or priority level was not evidenced in the medical record. P-6: The start of care (SOC) date to the home care Agency was 5/1/25, with diagnoses which included spinal stenosis-cervical region, post-surgical spinal decompression with fusion, and hypertension. On 5/14/25, a record review of the patient's individualized emergency plan revealed no specific aspects of concern that would be considered in the event of an emergency that would involve P-6. P-7: The SOC date to the home care Agency was 5/7/25, with diagnoses which included gastrointestinal hemorrhage, asthma, acute hypoxia with supplemental oxygen, and history of falls. On 5/14/25, a record review of the patient's individualized emergency plan revealed no specific aspects of concern that would be considered in the event of an emergency that would involve P-7. During a joint home visit with physical therapy services on 5/14/25, it was observed that P-7 had a higher level of acute needs such as supplemental oxygen with multiple trip hazards (30 feet of oxygen tubing), recent multiple falls, legally blind, altered mentation, and additional care needs for a physically impaired and severely demented spouse. None of the above were included on P-7's individualized emergency plan. The above findings were reviewed and acknowledged during an interview with the Agency's Clinical Manager on 5/15/25 at 3:10 PM.

A Medicare authorized recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/13/25 through 5/16/25 at: Fox Run Home Health Agency 41100 Fox Run Road Novi, MI 48377 This agency did not have any additional branch locations. During this survey, 3 records were reviewed with home visits; 2 records without home visits; 2 discharged records, for a total of 7 records reviewed. At the conclusion of the survey, the agency was found to be out of compliance with the Conditions of Participation at 42 CFR 484 Home Health Services.

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 1 (P-1) of 3 patients observed during home visits, from a total of 7 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: P-1: The patient's start of care was 4/22/25 with diagnoses that included Wedge Compression Fracture T11-T12 Vertebra. On 5/14/25 at 1:00 p.m., a scheduled survey home visit was conducted with the Occupational Therapist (OT #1). During a review of the clinical record, it was noted that the patient was ordered to receive Skilled Nursing, Physical Therapy and Occupational Therapy services. 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 ordered disciplines. Upon completion of the visit, the patient was queried as to how he is aware of which disciplines are coming out and what times the visits are scheduled for and replied, "They generally just call and tell us when they're coming." The agency failed to ensure the patient was included in the overall planning of care. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 5/16/25 at 11:37 a.m.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to ensure the patient's Activity of Daily Living needs were adequately met in the patient's home for 1 (P-2) patient assessed as needing assistance with ADLs, resulting in the potential for poor hygiene, psychological decline and unmet care needs. Findings include: P-2: The patient's start of care was 5/6/25 with diagnoses that included Hypertensive Heart Disease with Heart Failure, congestive Heart Failure, Dilated Cardiomyopathy and Head Injury. The Plan of Care ordered Skilled Nursing and Physical Therapy services to be provided. During the record review on 5/13/25 at 1:50 p.m., it was noted that section M1800 of the Initial comprehensive Assessment documented the patient required assistance with grooming, dressing and toileting. Further review of the clinical record revealed no documented evidence that a Home Health Aide was either offered or provided. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 5/16/25 at 12:08 p.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 observation, record review and interview, it was determined the Agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects, and failed to alert the physician of the use of an experimental medication in 1 (P-7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all 21 patients currently serviced by this Agency. Findings include: P-7: The SOC date to the home care Agency was 5/7/25, with diagnoses which included gastrointestinal hemorrhage, asthma, acute hypoxia with supplemental oxygen, and history of falls. During a joint home visit with physical therapy services on 5/14/25, a review of P-7's prescription medication bottles noted a discrepancy when compared to the Agency's medication list generated during the comprehensive assessment. The medication in question was Ofev (100 mg. twice a day), an experimental drug used to treat lung scarring. The medication was not found on P-7's Plan of Care medication list. P-7 was queried when she started taking Ofev. P-7 replied, "About three months ago." This finding was reviewed and acknowledged during an interview with the Agency's Clinical Manager (CM #1) on 5/15/25 at 3:25 PM. CM #1 stated that due to Ofev being an experimental drug, it did not show up in the Agency's formulary drug review. However, no documentation was found in the medical record that this medication existed, or that the physician was made aware of Ofev.

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 precautions and objectively measurable goals specific to the needs of the patient for 3 (P-2, P-3, P-7) of a total of 7 sampled records reviewed, resulting in the potential for poor outcomes and unidentified trackable progress in meeting patient care goals. Findings include: P-7: The SOC date to the home care Agency was 5/7/25, with diagnoses which included gastrointestinal hemorrhage, acute hypoxia with supplemental oxygen, and history of falls. On 5/14/25, a record review of P-7's POC noted no oxygen safety precautions to alert staff and individuals of potential dangers associated with the use of medical grade oxygen. Further review found no evidence of parameters to notify the physician concerning P-7's respiratory rate despite the known history of respiratory compromise. An additional review of the POC found 10 of 10 Skilled Nursing goals were not written in measurable terms. Examples include: "Pt/cg (patient/care giver) able to take/administer medications as ordered; Pt/cg independent in safe use of oxygen; Pt/cg verbalizes understanding of homecare service delivery." The above findings were reviewed and acknowledged during an interview with the Agency's Clinical Manager on 5/15/25 at 3:15 PM. P-2: The patient's start of care (SOC) was 5/6/24 with diagnoses that included Hypertensive Heart Disease with Heart Failure Congestive Heart Failure (CHF), Dilated Cardiomyopathy and Head Injury. During the record review on 5/13/25 at 1:50 p.m., it was noted that the Plan of Care (POC) indicated the dates of the listed diagnoses all exacerbated on the date of admission. The POC failed to include interventions to manage CHF such as weights, reportable weight parameters and associated goals. The interventions were vague such as, pt verbalize s/s of CHF to report, but did not give examples. Interventions were to assess orthostatic BP, pulses… no frequency noted. No Respiratory parameters noted. Goals were not measurable, such as, endocrine status will stabilize by... The POC did not address the individualized needs of the patient. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 5/16/25 at 12:08 p.m. P-3: The patient's SOC was 5/2/25 with diagnoses that included Multiple Rib Fractures, Vertigo, Seizures and Brain Injury. During the record review on 5/14/25 at 4:00 p.m., it was noted that the POC listed the patient's chief diagnosis of rib fracture as having occurred 10/1/2013, however, the incident actually occurred on 4/8/25. Further, the POC was void of seizure and fall precautions. There were no interventions to monitor for seizures and no associated goals to address seizure activity. These findings were reviewed with and confirmed by CM #1 during an interview on 5/16/25 at 12:32 p.m.

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 3 (P-2, P-3, P-7) patients who experienced a significant change in condition, including low oxygen levels, increased pain and seizure activity, from a total of 7 sampled records reviewed, resulting in unidentified, untreated health conditions and the potential for worsening of health conditions. Findings include: P-2: The patient's start of care (SOC) was 5/6/24 with diagnoses that included Hypertensive Heart Disease and Congestive Heart Failure. During the clinical record review on 5/13/25 at 1:50 p.m., it was noted that the Plan of Care (POC) ordered the Physician to be notified of patient's pain level greater than 4/10. On 5/14/24, the Physical Therapist (PT) documented the patient's pain level at 6/10. There was no documented evidence that the PT promptly reported these findings to the Physician. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 5/16/25 at 12:08 p.m. P-3: The patient's SOC was 5/2/25 with diagnoses that included Multiple Rib Fractures, Dementia and Brain Injury. The POC ordered SN, PT Occupational Therapy (OT) and Speech Therapy (ST) services to be provided. During the clinical record review on 5/14/25 at 4:00 p.m., a PT visit note dated 5/5/25 revealed that upon arrival, "the patient's daughter reported the patient had a seizure the morning of 5/5/25. Pt reported full body tremors and pain due to seizure activity. Pts daughter also indicated occasional stuttering speech as symptom of seizure." Upon further review, there was no documented evidence that the PT promptly notified the Physician of the patient's seizure activity. These findings were reviewed with and confirmed by CM #1 during an interview on 5/16/25 at 12:32 p.m. P-7: The SOC date to the home care Agency was 5/7/25, with diagnoses which included gastrointestinal hemorrhage, acute hypoxia with supplemental oxygen, and history of falls. On 5/14/25, review of P-7's Plan of Care (effective on 5/7/25), directed all clinicians to notify the physician if blood oxygen levels fell below 90% saturation. Further review of the Physical Therapy (PT) evaluation performed on 5/8/25, noted the following concern. Documentation by PT services noted pre-therapy blood oxygen level at 92% on room air (95%-100% is considered normal). PT further documented P-7 "does not check O2 (oxygen) at home." Under "Post-Treatment Vitals" PT documented P-7's blood oxygen level "as low as 88% with activity on RA (room air)." No use of oxygen during therapy was documented by PT services. No notification to the physician was evidenced in the medical record. The above findings were reviewed and acknowledged during an interview with the Agency's Clinical Manager (CM#1) on 5/15/25 at 3:15 PM. CM#1 noted the PT should have notified the physician for further guidance.

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 1 (P-1) of 3 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 7 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: P-1: The patient's start of care was 4/22/25 with diagnoses that included Wedge Compression Fracture T11-T12 Vertebra. During the record review on 5/13/25 at 12:45 p.m., it was noted that the Plan of Care ordered Skilled Nursing, Physical Therapy and Occupational Therapy services to be provided. On 5/14/25 at 1:00 p.m., a scheduled survey home visit was conducted with the Occupational Therapist (OT #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 that had been provided by this agency. The patient was queried and expressed no knowledge of ever having a Medication list that had been provided by the agency and stated, "We only have the medication list from the hospital." These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 5/16/25 at 11:37 a.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the registered nurse performed ongoing assessments of the patient's health status and needs in 1 (P-2) record of a patient with a diagnosis of congestive heart failure, from a total of 7 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings included: P-2: The patient's start of care was 5/6/24 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Congestive Heart Failure (CHF), Dilated Cardiomyopathy and Head Injury. The Plan of Care ordered Skilled Nursing (SN) services to be provided at a frequency of 1x/wk. x 3 wks. During a review of the clinical record on 5/13/25 at 1:50 p.m., it was noted that the SN documented a baseline weight of 130 pounds (lbs.) at the time of admission. It could not be determined if this was an actual or stated weight. Upon further review of the SN visit notes dated 5/13/24 and 5/20/24, there were no documented weights. Additionally, there was no assessment of the patient's edema in light of her diagnosis of CHF. The SN failed to conduct ongoing assessments of the patient's health status. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 5/15/25 at 12:08 p.m.

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 Speech Therapist completed the initial assessment in order to assist the physician in evaluating the patient's level of function and helped to develop the plan of care for 1 (P-3) record of a patient who required Speech Therapy services, from a total of 7 sampled records reviewed, resulting in the potential for decline in physical functioning and unmet care needs. Findings include: P-3: The patient's start of care was 5/2/25 with diagnoses that included Multiple rib Fractures, Demetia, Anxiety, Vertigo and Brain Injury. The Plan of Care ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and Speech Therapy (ST) services to be provided. On 5/14/25 at 4:00 p.m., during a review of the clinical record, it was noted that the Speech Therapy evaluation dated 5/8/25 was incomplete. The section titled "oral Examination" used to assess the patient's Jaw: range of motion, coordination, strength; Lips: range of motion, coordination, strength; Tongue: range of motion, coordination, strength, were all left blank and documented, "Not tested." The section titled, Swallowing: oral phase, pharyngeal phase, signs of aspiration, were all left blank and documented "Not tested." The section titled Reading Comprehension was left blank. The Speech Therapy evaluation was void of a detailed assessment of the patient's health status that would aid the Physician in evaluation of the patient's needs and formulating the Plan of Care. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 5/16/25 at 12:32 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 home health aide (HHa) plan of care included all safety precautions concerning patient care in 1 (P-5) of 1 record reviewed with aide services, out of a total sample of 7 records reviewed, resulting in the potential for unmet patient care needs. Findings include: P-5: The patient was admitted to the home care Agency on 3/21/25, with diagnoses which included disruption of surgical wound, status-post pulmonary embolism, and hypertensive heart disease. On 5/13/25, a record review of P-5's Plan of Care/485 noted multiple safety precautions when providing patient care and interventions. One of the precautions was to be aware of potential skin breakdown. This precaution failed to be carried over and included into the HHa plan of care, which would alert the HHa to report any findings to skilled nursing services. The above findings were reviewed and acknowledged during an interview with the Agency's Clinical Manager on 5/15/25 at 2:55 PM.

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, it was determined the Agency failed to ensure the home health aide (HHa) provided services as ordered in 1 (P-5) of 1 record reviewed with aide services, out of a total sample of 7 records reviewed, resulting in the potential for unmet patient care needs. Findings include: P-5: The patient was admitted to the home care Agency on 3/21/25, with diagnoses which included disruption of surgical wound, status-post pulmonary embolism, and hypertensive heart disease. On 5/13/25, a record review of the aide care plan noted the HHa was to perform home visits twice a week for two weeks which included bathroom organizing for ADL (activities of daily living) for P-5's safety needs. Additional review of the HHa visits completed noted that on 4/8/25, there was no documentation that indicated the HHa had performed bathroom interventions as stipulated in the aide plan of care. The above findings were reviewed and acknowledged during an interview with the Agency's Clinical Manager on 5/15/25 at 2:50 PM.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the clinical record was completed and included detailed notes regarding the health status of the patient for 1 (P-2) record of a patient who experienced a significant change in condition, from a total of 7 sampled records reviewed, resulting in the potential for undocumented, unidentified health concerns, and unmet patient needs. Findings include: P-2: The patient's start of care was 5/6/24 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Congestive Heart Failure and Head Injury. The Plan of Care ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. During the clinical record review on 5/13/25 at 1:50 p.m., a PT note dated 5/8/24 documented, "Pt (patient) in hospital d/t (due to) blood transfusion. Request PT next wk. (week)." There was no additional documentation in the patient's clinical record as to what happened after this event. It could not be determined if the patient was hospitalized/admitted and if so, for what duration. The agency failed to ensure the patient's clinical record was complete and contained detailed visit/communication notes that documented the health status of the patient. These findings were reviewed with and confirmed by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 5/16/25 at 12:08 p.m. When asked if the patient was admitted to the hospital and what the status of the patient was after this incident, CM #1 reported, "I can't answer that. I don't see anything else documented."

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 the transfer/discharge summaries were complete, provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 2 (P-1, P-2) records in which the patient was discharged/transferred from the agency's services, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-1: The patient's start of care (SOC) was 4/22/25 with diagnoses that included Wedge Compression Fracture T11-T12 Vertebra. The Plan of Care (POC) ordered the patient to receive Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. During the clinical record review on 5/13/25 at 12:45 p.m., it was noted that the patient was transferred to an inpatient facility due to not having a bowel movement in 6 days, with resultant small bowel obstruction. Upon further review, there was no transfer summary available for review that detailed the reason for admission, course of care provided, status at the time of transfer and any continuing needs as per this requirement. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 5/16/25 at 11:37 a.m. P-2: The patient's SOC was 5/6/25 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Congestive Heart Failure, Dilated Cardiomyopathy and Head Injury. The POC ordered SN and PT services to be provided. During the record review on 5/13/25 at 1:50 p.m., it was noted that the patient was discharged from SN services on 5/20/24. The SN Discharge Summary dated 5/20/24 was void of a detailed summary of the course of care provided and the overall health status of the patient at the time of discharge. The summary failed to include the patient's discharge weight, pain level, measurement of edema and discharge pain level. Additionally, there were no documented vital signs and no indication of which goals were met. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 5/16/25 at 12:08 p.m.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/6/22 through 6/9/22 at: Fox Run Home Health Agency 41100 Fox Run Road Novi, MI 48377 This was a standard survey. The requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness were not reviewed.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/6/22 through 6/9/22 at: Fox Run Home Health Agency 41100 Fox Run Road Novi, MI 48377 At the time of the survey, the agency did not have any branch offices or subunits. For this survey, 2 active records without home visits; 3 active records with home visits; and 2 discharge records were reviewed for a total of 7 records reviewed. At the conclusion of the survey, the agency was found to be out of compliance with a standard level deficiency for the conditions of participation for home health agencies at: 42 CFR Part 484.

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 individualized, patient-specific, measurable outcomes and goals in 5 (MR# 1, 4, 5, 6, 7) of 7 sample records resulting in a lack of patient inclusion in care planning and potential for unmet patient care needs. Findings include: MR#4: This patient was admitted to the agency on 9/3/21 with diagnoses of hypertensive chronic kidney disease, diabetes, and difficulty swallowing. The patient was hospitalized (8/10/21 to 8/14/21) for a fall that resulted in an abdominal hematoma. The patient then transferred to a skilled rehabilitation center from 8/14/21 through 9/3/21. During record review on 6/7/22, it was noted that the SN goals in the POC were not measurable. The POC included the following generic goals for this patient: patient will achieve a satisfactory level of pain control, demonstrates knowledge of and compliance with diet, and will follow precautions related to anticoagulant therapy. There was no indication of the patient's satisfactory level of pain control and no indication as to how these nursing goals would be objectively measured to determine the patient's progress towards discharge. These findings were reviewed and acknowledged by Admin-A and CM-B during an interview on 6/9/22 at 9:00 a.m. MR#5: This patient was admitted to the agency on 5/12/22 with diagnoses of congestive heart failure and acute respiratory failure with hypoxia (oxygen not available in sufficient amounts for delivery to body tissues). The patient had been recently hospitalized due to an exacerbation of shortness of breath and was discharged on 5/11/22. During record review on 6/6/22, it was noted that the SN goals in the POC were not measurable. The POC included the following generic goals for this patient: patient will achieve a satisfactory level of pain control, independent in safe use of oxygen, and verbalize/demonstrate understanding of nutritional needs. There was no indication of the patient's satisfactory level of pain control and no indication as to how these nursing goals would be objectively measured to determine the patient's progress towards discharge. These findings were reviewed and acknowledged by Admin-A and CM-B during an interview on 6/9/22 at 9:00 a.m. MR#6: This patient was admitted to the agency on 5/23/22 with diagnoses of osteoporosis (weak/brittle bones) with a current left arm fracture due to a recent fall. During record review on 6/6/22, it was noted that the SN goals in the POC were not measurable. The POC included the following generic goals for this patient: patient will follow precautions related to anticoagulant therapy, will have increased knowledge of depression treatment, and there was no pain goal established with the patient. There was no indication as to how these nursing goals would be objectively measured to determine the patient's progress towards discharge. These findings were reviewed and acknowledged by Admin-A and CM-B during an interview on 6/9/22 at 9:00 a.m. MR#7: This patient was admitted to the agency on 5/17/22 with diagnoses of a stage 2 (loss of skin with a shallow open area) pressure ulcer on the lower back and heart failure. During record review on 6/6/22, it was noted that the SN goals in the POC were not measurable. The POC included the following generic goals for this patient: patient's pain will be controlled within limits of disease, will achieve a satisfactory level of pain control, and increased awareness of fall prevention and safety factors in the home to decrease fall risk. There was no indication of the patient's satisfactory level of pain control and no indication as to how these nursing goals would be objectively measured to determine the patient's progress towards discharge. These findings were reviewed and acknowledged by Admin-A and CM-B during an interview on 6/9/22 at 9:00 a.m. MR#1: This patient was admitted to the agency on 6/25/21 with a primary diagnosis of right humerus fracture (break in the bone of the upper arm). During record review of the plan of care (POC) on 6/6/22, the skilled nurse (SN) failed to incorporate measurable nursing goals including a pain goal that was established by this patient who had a primary diagnosis which was noted in the record to cause daily pain. The POC included the following goals: Patient will achieve a satisfactory level of pain control and will take pain medications as ordered, and: patient will verbalize return to acceptable comfort/pain level. There was no patient specific acceptable comfort/pain level or goal indicated in the record making it difficult to determine if the patient’s level of pain was controlled or acceptable to the patient. These findings were reviewed and acknowledged by Administrator (Admin-A) and Clinical Manager (CM-B) during interview on 6/9/22 at 9:35 a.m.