Every finding on record at New Horizon Home Health Care, Inc

The following deficiencies were identified during an Emergency Preparedness Survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 3/2/26 through 3/5/26 at: VN Home Health care28230 Orchard Lake Rd., Ste. 215Farmington Hills, MI 48334At the time of the survey, VN Home Health Care was found to be in substantial compliance with the requirements for the Conditions of Participation at: 42 CFR §484.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every two years, resulting in lack of direction for agency personnel in the event of an actual emergency or disaster. Findings include: On 3/2/26 at 11:05 a.m., during a review of the agency's "Emergency Preparedness Disaster Plan", it was noted that the plan was undated. There was no documented evidence that the plan had been reviewed and updated at least every 2 years as per this requirement. Additionally, the plan was void of any mitigating strategies to address the hazards/potential hazards identified in the agency's Hazardous Vulnerability Assessment. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:20 a.m.

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 ensure its Emergency Preparedness policies and procedures were reviewed and updated at least every 2 years, resulting the potential for undesired responses in the event of an emergency. Findings include: On 3/2/26 at 11:05 a.m., during a review of the agency's Emergency Preparedness documents, it was noted that the "Emergency and disaster Preparedness Policy/Procedure #: E-410" was last "reviewed" on 9/2025. There was no specific documented date of review and no indication or name of who reviewed the policy. Additionally, there was no documented evidence that the policies/procedures had been updated at least every 2 years as per this requirement. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:20 a.m.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure an individual Emergency Preparedness Plan was completed for 1 (P-2) of 3 patients observed during a home visit, resulting in the potential for unprepared responses in the event of an actual emergency or disaster. Findings include: Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. On 3/3/26 at 11:15 a.m., a scheduled survey home visit was conducted with the Physical Therapist (Staff-C). During a review of P-2's Admission Packet, it was noted that the patient's individualized Emergency Preparedness Plan was blank. There was no information provided that would assist staff or patients in the event of an emergency. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.m.

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), §485.542(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, REHs at §485.542, 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 training and testing program for staff that is based on the emergency plan, the risk assessment, policies and procedures, and the communication plan of this section, that had been reviewed and updated at least every two years. Findings included: On 3/2/26 at 11:05 a.m., during a review of the agency's Emergency Preparedness Plan, there was no evidence that the agency's Testing and Training requirements had been reviewed and updated at least every 2 years, as per this requirement. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:20 a.m.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Survey and Certification, on 3/2/26 through 3/5/26 at: VN Home Health Care 28230 Orchard Lake Rd., Suite 215 Farmington, MI 48334 At the time of the survey, the agency did not have any branch offices or subunits. For this survey, 3 home visits with record reviews, 1 active record without a home visit, and 3 discharged records were reviewed for a total of 7 records reviewed. At the conclusion of the survey, the agency was found to be in substantial compliance for the conditions of participation for home health agencies at: 42 CFR Part 484.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide proper written notice of non-coverage prior to terminating ongoing services for 1 (P-1) of 3 patients discharged from the agency's services. Findings include: Patient #1 (P-1)'s start of care was 4/21/25 with diagnoses that included End Stage Heart Failure and Abnormal Gait. During the clinical record review on 3/2/26 at 11:45 a.m., it was noted that P-1 was discharged from the agency's services on 6/4/25. Upon further review, it was noted that P-1 was issued and signed the notice of non-coverage on the same date she was discharged from the agency's services. The agency failed to ensure the notice of non-coverage was provided prior to terminating services. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Registered Nurse conducted the initial assessment visit within 48 hours of referral to determine the immediate care and support needs of the patient, for 1 (P-2) of 1 patient in which nursing services was ordered, resulting in the delay in nursing services and the potential for decline in health status. Findings include: Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis that included Idiopathic Progressive Neuropathy. During the clinical record review on 3/2/26 at 2:40 p.m., it was noted that the referral for home care was dated 1/21/26. The Plan of Care ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. During the review, it was noted that the SN conducted the initial Comprehensive Assessment 6 days after the date of the referral on 1/27/26. There was no documented rationale for the delay in needed services. Further, there was no evidence that the Physician had been notified or approved the delay in care. The Administrator reviewed and acknowledged these findings during an interview on 3/5/26 at 10:05 a.m.

Skilled professional performs assessment CFR(s): 484.55(a)(2) When rehabilitation therapy service (speech language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician or allowed practitioner who is responsible for the home health plan of care, the initial assessment visit may be made by the appropriate rehabilitation skilled professional. For Medicare patients, an occupational therapist may complete the initial assessment when occupational therapy is ordered with another qualifying rehabilitation therapy service (speech-language pathology or physical therapy) that establishes program eligibility. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Physical Therapist conducted the initial assessment visit within 48 hours of referral to determine the immediate care and support needs of the patient, for 1 (P-1) of 1 patient in which therapy services was ordered. Findings include: Patient #1 (P-1)'s start of care (SOC) was 4/21/25 with diagnoses that included End Stage Heart Failure and Abnormal Gait. During the clinical record review on 3/2/26 at 11:45 a.m., it was noted that the referral for home care was dated 4/16/25, and ordered Physical Therapy (PT) services to be provided. Upon further review, it was noted that PT conducted the initial assessment 5 days after the date of the referral. The PT failed to conduct the initial assessment within 48 hours of the referral to ascertain the patient's immediate care needs and establish homebound status as per this requirement. Further, there was no documented evidence that the Physician was notified and/or approved of the delay in services. The Administrator reviewed and confirmed these findings during an interview on 3/5/26 at 9:55 a.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (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 in 3 (P-4, P-6 and P-7) of 7 records reviewed, resulting in a lack of information to aid in determining patient care needs and the potential for poor clinical outcomes. Findings include: Patient #6 (P-6): The start of care (SOC) to the agency was 12/26/25 and included diagnoses of a pressure ulcer-stage 3 on left buttock, hypertension, heart failure-unspecified, and dysphagia. On 3/4/26, patient record review noted P-6 had a speech therapy (ST) evaluation during hospitalization on 12/12/26. ST documented, “No straws or regular cups” to reduce to risk of aspiration (accidental inhalation of swallowing liquids or food into the lungs) and enteral feeding (liquid nutrition directly into the stomach through a feeding tube) “four times a day.” Hospital discharge instructions on 12/17/25 documented, “Elevate HOB (head of bed) 30 to 45 degrees at all times during feeding and for at least 30 to 40 minutes after the feeding is stopped.” The SOC comprehensive assessment failed to take note of and include any of the above findings. Subsequently, the plan of care for P-6 had no interventions/treatments to mitigate the above safety concerns. Patient #7 (P-7): The SOC was dated 3/16/25 and included diagnoses of heart disease with congestive heart failure, diabetes-type 2, and chronic kidney disease-stage 5. P-7 also had a diagnosis of "Dependence on supplemental oxygen" and review of the SOC comprehensive assessment documented an absence of "No Smoking" signs in P-7's home. However, this finding had no evidence of being followed up on during the SOC assessment or any other assessments from admission through 4/6/25 (last entry in the medical record). On 4/6/25, P-7 was transferred to the hospital (reason unknown) with no resumption of care by the agency. The assessment failed to note when oxygen was started, how often P-7 required oxygen, and the patient's response when using the oxygen. Another example is P-7's diabetes with a diagnosis of "Long term (current) use of insulin". The SOC assessment under "Endocrine" that details diabetic history failed to acknowledge the use of insulin and when the insulin was started or the management of insulin administration for P-7. The findings above were reviewed and acknowledged by the administrator (Staff-A) during an interview on 3/5/26 at 1:53 PM. Patient #4 (P-4): The start of care (SOC) to the agency was 7/31/25 with the diagnoses of breast cancer and pleural effusions. During the review of the medical records on 3/3/26 it revealed that P-4 was discharged from a senior nursing facility (SNF) on 7/30/25 to home with a pleurx drain (thin tube placed in the chest to drain excess fluid around the lungs, into a vacuum bottle). The discharge summary from the SNF noted that P-4 was being treated for pleural effusions and under the care of Pulmonology (lung doctor) with “pleurx drain since May 2025." The notes further explained that the patient was seen by the SNF provider on 7/21/25 “for clarification orders… no orders for how often pleurx drain needs to be drained. Per review of pulmonology notes, will resume weekly draining. Dressing change with draining, needs to be sterile change." The review the SOC comprehensive assessment noted under the “Respiratory Status: “Patient recently hospitalized for pleural effusion with tube to right side of chest wall intact. (Patient has return visit to dr for pleural effusion evaluation)." The assessment lacked documentation of a drain and or puncture site under the assessments of special treatments, potential risk for infection, and surgical wounds. Subsequently, the plan of care for P-4 was without interventions/treatments needed to manage the care of the pleurx drain. During the interview 3/5/26 at 2:11 PM the findings were reviewed and acknowledged by the Agency’s administrator (Staff-A).

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure the Initial Comprehensive Assessment included a thorough and accurate review of all medications for 1 (P-2) of 1 patient observed during a home visit, resulting in the potential for harmful medication effects. Findings include: Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. During the record review on 3/2/26 at 2:40 p.m., it was noted that section M2001 of the comprehensive assessment completed by the Registered Nurse documented, "No issues found during review." However, the agency's drug interaction report revealed multiple moderate drug to drug interactions. On 3/3/26 at 11:15 a.m., a scheduled survey home visit was conducted with the Physical Therapist (Staff-C). During the visit, it was noted that there was no medication profile that listed all the patient's medications. Further observations revealed a bag of prescription medications on the patient's floor. When queried about the medications, P-2 responded, "I've had those medications ever since I first became sick." When asked if she still takes any of the identified medications, P-2 said, "I don't think so because there's another bag of pills in the kitchen. My son takes care of that for me." Based on the above findings, there was no evidence that the Registered Nurse included all the patient's medications, including prescription and over the counter medications to determine any untoward interactions. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.m.

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 the Plan of Care (POC) for skilled nursing (SN) included objective measurable goals in 4 (P-4, P-5, P-6, and P-7) of 7 records reviewed; failed to provide skilled nursing services as ordered in 1 (P-6) of 7 records reviewed; and failed to include pertinent safety precautions in 1 (P-7) of 7 records reviewed, resulting in the potential for unmet patient care needs. Findings include: Patients #5, #6, and #7: On 3/3/26 through 3/5/26, review of each of the patient’s POC noted the following: P-5 (5 of 5 SN goals), P-6 (2 of 2 SN goals), and P-7 (31 of 31 SN goals) were not written in objective measurable terms to track and trend progress made (or lack of) as required. Example goals include: “Patient demonstrate necessary skills to self-manage disease process including medication management, when to notify physician, s/s (signs and symptoms) necessitating emergent care, nutrition and activity… Patient/Caregiver will be able to identify fall risk factors by 3/16/25.” Patient #6 (P-6) had the POC ordered SN services twice weekly for 3 weeks, followed by weekly visits for 3 weeks, effective 1/19/26. Patient record review on 3/4/26 noted only 1 SN visit was provided weekly from 1/19/25 through 1/31/25. No physician notification or patient refusal was found in the P-6's medical record. Patient #7 (P-7) was ordered to have supplemental oxygen on 3/16/25 at a rate of 2 Liters/minute when short of breath due to congestive heart failure. The POC failed to include oxygen precautions to help ensure safety for all individuals in the home. The findings above were reviewed and acknowledged by the administrator (Staff-A) during interviews conducted on 3/5/26 at 12:37 PM through 1:57 PM. Patient #4 (P-4) was admitted to the agency on 7/31/25 with a diagnosis of breast cancer and pleural effusions. On 3/2/26, a review of the Plan of Care (POC) effective 7/31/25, revealed 31 out of 32 listed goals were not written in objective measurable terms. For example, “Patient will maintain blood sugar within normal range by end of episode as evidenced by reading within therapeutic range” Another goal stated, “Patient will remain free of any and all infections during this episode of care”. The Agency Administrator (Staff-A) acknowledged the findings during an interview on 3/5/26 at 2:11 PM, which did not meet agency expectations or their policy referenced below. A review of agency policy titled, “Physician’s Plan of Treatment/Change Orders” (undated), revealed, “The plan of treatment shall include but not be limited to … Measurable outcomes and goals…”

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 (POC) included pertinent safety precautions in 2 (P-6, P-7) of 7 records reviewed, resulting in the potential for poor clinical outcomes and patient harm. Findings include: Patient #6 (P-6): The start of care (SOC) to the agency was 12/26/25 and included diagnoses of a pressure ulcer-stage 3 on left buttock, hypertension, heart failure-unspecified, and dysphagia. On 3/4/26, patient record review noted P-6 had a speech therapy (ST) evaluation during hospitalization on 12/12/26. ST documented, “No straws or regular cups” to reduce to risk of aspiration (accidental inhalation of swallowing liquids or food into the lungs) and enteral feeding (liquid nutrition directly into the stomach through a feeding tube) “four times a day.” Hospital discharge instructions on 12/17/25 documented, “Elevate HOB (head of bed) 30 to 45 degrees at all times during feeding and for at least 30 to 40 minutes after the feeding is stopped.” The POC for P-6 had no interventions or treatments to mitigate the above safety concerns. Patient #7 (P-7): The SOC was dated 3/16/25 and included diagnoses of heart disease with congestive heart failure, diabetes-type 2, and chronic kidney disease-stage 5. P-7 also had a diagnosis of "Dependence on supplemental oxygen" and review of the SOC comprehensive assessment documented an absence of "No Smoking" signs in P-7's home. However, this finding had no evidence of being followed up on during the SOC assessment or any other assessments from admission to hospital transfer with no return on 4/6/25. The lack of oxygen safety precautions on P-7's POC allowed the risk associated with oxygen use to go unrecognized. The findings above were reviewed and acknowledged by the administrator (Staff-A) during an interview on 3/5/26 at 1:49 PM.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the physician was promptly notified of a significant change in condition for 1 (P-2) of 1 patient who experienced a significant reduction in weight, resulting in the potential for unidentified, underlying, untreated patient care concerns. Findings include: Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. On 3/2/26 at 2:40 p.m., during the clinical record review, it was noted that the skilled nursing (SN) visit notes documented the following: SN visit note dated 1/27/26 documented P-2's baseline weight of 130 pounds (lbs.) It was unclear if this was an actual or stated weight. SN visit note dated 2/5/26 documented a weight of 129 lbs. SN visit note dated 2/10/26 documented a weight of 130 lbs. SN visit note dated 2/17/26 documented a weight of 111 lbs. This change reflected a 19 lb. unplanned weight loss. There was no documented evidence that the Physician had been promptly notified of this significant change in patient status. SN visit note dated 2/24/26 documented a weight of 112 lbs. On 3/3/26/at 11:15 a.m., a scheduled survey home visit was conducted with the Physical Therapist (Staff-C). During the visit, P-2 stated, "My doctor isn't happy about my current weight. I'm currently at 112 lbs. I have to force myself to eat. I'm doing the best I can." The agency failed to ensure the Physician was promptly notified of the patient's sudden 19 lb. weight loss. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.m. No additional response was offered.

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 failed to ensure that patient care services were coordinated to meet the clinical needs of a patient in 1 (P-7) of 2 records reviewed with hospital transfers, resulting in the potential for an unnecessary hospital transfer. Findings include: Patient #7 (P-7): This patient was admitted to the home care agency on 3/16/25 and included diagnoses of heart disease with congestive heart failure (CHF), diabetes-type 2, and chronic kidney disease-stage 5. The physician face to face with home care referral dated 3/5/25, documented the following concerning the health care acuities of P-7: "10 admissions this year for CHF... Was seen at (Hospital) on 2/26 for IV diuresis without a change in her weight and continued with NYHA class 4 (most severe stage of heart failure) symptoms... 2/10/26 - Admitted to (Hospital) for acute decompensated HFrEF (heart failure with reduced ejection fraction) and acute hypoxic resp failure." (sic) On 3/5/26, (Hospital physician) further documented, "If possible, would obtain standing weights given discrepancy between reported weight and bed scale weight." On 3/4/26, record review noted the plan of care (POC) ordered a skilled nursing (SN) visit frequency of 1WK1, 2WK1 (twice a week for 1 week), and 1WK6 effective 3/16/25. Further record review found the following concerns given the high risk for complications based on the history above: On 3/20/25, SN (Staff-J) provided a home visit and documented P-7's oxygen saturation was 90% on room air, down from 95% (room air) on 3/18/25 and 93% (room air) during admission on 3/16/25. The assessment section under "Respiratory" was blank other than a checked box noting intermittent oxygen use of 2 Liters per minute. No physician communication or follow-up visit by the agency was coordinated to assess if the 90% oxygen reading was an aberration or a continuing trend. P-7 was transferred to the hospital 4 days later on 3/24/25 due to CHF exacerbation (worsening) symptoms. P-7 was discharged from the hospital, and the agency performed a ROC (resumption of care) visit on 3/28/25. Record review found no physician discharge summary that described the treatments, interventions and clinical findings resultant from the hospital admission on 3/24/25. No documented effort was found in agency records that this information was requested, which would be vital for the ROC nurse to know in updating the POC to mitigate the risk of further hospitalization. The SN visit frequency was kept at once weekly times 4 weeks. Also, record review found 4 of 4 SN visits failed to note how P-7's weights were obtained (stated vs. actual by standing) as documented by the physician on 3/5/25 to ensure accuracy. No assessments or communication by the agency was provided until a missed visit note by SN on 4/3/25 due to an appointment for P-7 that day. No attempts of efforts were documented to assess or visit P-7 the rest of the week ending on 4/5/25. The patient was once again transferred to the hospital on 4/6/25 with no return and subsequent discharge from the agency. No SN visits were provided after the ROC visit (9 days), and no coordinated effort was made by the agency via SN, the physician, and agency administration to ensure appropriate monitoring and hospital clinical findings were in place to meet the clinical needs of this patient. The findings above were reviewed and acknowledged by the administrator (Staff-A) on 3/5/26 at 1:32 PM. Staff-A noted this did not meet agency expectations nor its policy referenced below. Agency Policy: "Care Coordination/Case Conferences) III.16 (undated) stated, "Assure communication and coordination of services in patient-goal directed activity on the part of each team member... Provide an arena for team members to discuss problematic concerns."

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, the agency failed to provide 1 (P-2) 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, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. On 3/3/26 at 11:15 a.m., a scheduled survey home visit was conducted with the Physical therapist (Staff-C). During a review of the patient's admission packet, it was noted that the Medication Profile was blank. During the visit, Staff-C stated, "The nurse is usually responsible for the medication list." The agency failed to ensure a Medication Profile was in place that listed the patient's prescribed medications, dosages and side effects as per this requirement. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.m.

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 3/2/26 at 10:25 a.m. 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. The Administrator reviewed and acknowledged these findings during an interview on 3/5/26 at 10:20 a.m.

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 its discipline utilized Infection Control standards of practice during the provision of care and services for 1 (P-2) of 3 patients observed during home visits, resulting in the potential for the development and spread of infection. Findings include: Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. On 3/3/26 at 11:15 a.m., a scheduled survey home visit was conducted with the Physical Therapist (Staff-C). During the visit, the following observations were made: Staff-C assessed the patient's vital signs (blood pressure, oxygen saturation, temperature, lung sounds). Staff-C then proceeded with the therapy session utilizing hand weights and ankle weights. During the observation, Staff-C donned a pair of gloves. Staff-C kept the same pair of gloves on for the duration of the visit. Upon completion of the session, Staff-C placed her blood pressure cuff and stethoscope inside her work bag. Staff-C then placed her pulse oximetry unit, hand weights and ankle weights inside plastic bags and inside her work bag. Staff-C did not clean any of her equipment prior to returning the items to her work bag. Additionally, Staff-C still had the same single pair of gloves on that were donned at the beginning of care. Upon conclusion of the visit, Staff-C was interviewed. When queried about the observations made during the visit, Staff-C offered no response. The Administrator was informed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.m.

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 Occupational Therapy services were provided as ordered by the Physician and in the Plan of Care for 1 (P-2) of 2 patients with Occupational Therapy services ordered; and failed to ensure Speech Therapy services were provided for as ordered for 1 (P-6) of 1 patient with Speech Therapy services ordered, resulting in the potential for physical decline, and unmet care needs. Findings include: Patient #6 (P-6) was admitted to the home care agency on 12/26/25 for pressure ulcer-stage 3 on left buttock, hypertension, heart failure-unspecified, and dysphagia. On 3/4/26, patient record review noted the following hospital physician order dated 12/18/25: "DISCHARGE resident to home with discharge instructions and medications, HHC (home health care) Nurse, Nurse Aide, PT/OT, SLP (speech-language pathologist)." Further review of P-6's Plan of Care/orders found no evidence that SLP services were provided from admission through survey exit on 3/5/26. In addition, no documentation was found of any refusal by P-6 (oriented times 2-3) and no notification to the physician that SLP services would not be provided as ordered. The findings above were reviewed and acknowledged by the administrator (Staff-A) during an interview conducted on 3/5/26 at 12:56 PM. Staff-A further acknowledged that all services ordered on the home care referral should have documentation of why they were not provided with another physician order. Patient #2 (P-2)'s start of care was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. During the clinical record review on 3/2/26 at 2:40 p.m., it was noted that a Physician's order dated 1/27/26 ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. The Physician's signed Plan of Care ordered SN, PT and OT services to be provided. At the time of this review, no OT services had been provided as ordered. Additionally, no OT services had been provided by the survey's exit on 3/5/26. Further, there was no documented evidence that P-2 declined to receive OT services. The Administrator reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.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, the agency failed to ensure the registered nurse included safety measures in the aide plan of care in 1 (P-6) of 2 records reviewed with home health aide services, resulting in the potential for the provision of unsafe care. Findings include: Based on record review and interview, the agency failed to ensure the registered nurse included safety measures in the aide plan of care in 1 (P-6) of 2 records reviewed with home health aide services, resulting in the potential for the provision of unsafe care. Findings include: Patient #6 (P-6) was admitted to the home care agency on 12/26/25 for pressure ulcer-stage 3 on left buttock, hypertension, heart failure-unspecified, and dysphagia. On 3/4/26, patient record review noted P-6 had a speech therapy (ST) evaluation during hospitalization on 12/12/26. ST documented, “No straws or regular cups” to reduce to risk of aspiration (accidental inhalation of swallowing liquids or food into the lungs) and enteral feeding (liquid nutrition directly into the stomach through a feeding tube) “four times a day.” Hospital discharge instructions on 12/17/25 documented, “Elevate HOB (head of bed) 30 to 45 degrees at all times during feeding and for at least 30 to 40 minutes after the feeding is stopped.” Hospital records also noted P-6 had multiple falls (11/30/25 and 12/1/25) as P-6 was “too close to the edge of the bed and couldn’t stop rolling and flipped of the bed.” During home admission on 12/26/25, the Plan of Care (POC) documented “Bed confinement status” due to the above falls risk and the use of a bedside commode. However, review of the aide plan of care on 3/4/25 found no documentation concerning safety instructions of P-6’s hospital bed regarding side rails to protect from additional falls, no acknowledgement to use the bedside commode, no aspiration precautions such as no straws/regular cups, and no documentation of the HOB being elevated related to feedings. The findings above were reviewed and acknowledged by the administrator (Staff-A) during an interview on 3/5/26 at 12:50 PM. Staff-A was further noted that this did not meet agency expectations.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to ensure a clinical manager was available during operating hours, resulting in the potential for unmet health care needs for all 12 patients currently receiving services at the time of the survey. Findings include: During the survey entrance conference on 3/2/26 at 9:50 AM, the agency’s administrator stated the clinical manager was on vacation and the alternate administrator was providing coverage. However, presence of a clinical manager was not observed or noted throughout any of the survey, which was conducted during normal operating business hours from 3/2/26 through 3/5/26 during the hours of 9:30 AM through 3:30 PM. The findings above were reviewed and acknowledged by Staff-A during an interview at the survey's exit conference on 3/5/26 at 3:05 PM.

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 detailed discharge summary was sent to the physician within 5 business days of discharge for 4 (P-1, P-2, P-4, and P-7) of 4 patients who were discharged from the agency or agency services, and failed to ensure a transfer summary was sent to the physician within 2 business days for 2 (P-4, P-7) of 2 patients requiring transfer of care, resulting in lack of information to aid in post-discharge/transfer continuity of care. Findings include: Patient #7 (P-7): The SOC was dated 3/16/25 and included diagnoses of heart disease with congestive heart failure (CHF), diabetes-type 2, and chronic kidney disease-stage 5. On 3/4/26, patient record review noted P-7 was transferred to the hospital on 3/24/25 due to CHF exacerbation (worsening) symptoms. P-7 was discharged from the hospital, and the agency performed a ROC (resumption of care) visit on 3/28/25. The patient was once again transferred to the hospital on 4/6/25 with no return and subsequent discharge from the agency. The findings above were reviewed and acknowledged by the administrator (Staff-A) on 3/5/26 at 1:32 PM. Staff-A was requested to show evidence that the transfer and discharge summaries were sent to the physician. Staff-A responded that the agency notifies the physician of transfers and discharges but acknowledged the agency does not have a system in place that time stamps and captures when all the summaries are sent to the physician. No evidence was found during the interview that showed the above transfer and discharge summary were sent to the physician within the required timeframes (2 business of transfer and 5 business days of discharge). Patient #4 (P-4) was admitted to the agency, episode 7/31/25 through 9/8/25, with the diagnoses of breast cancer and pleural effusions. Review of records on 3/3/26 revealed that P-4 required emergency care and ultimately hospitalization twice (8/7/25 and 8/17/25) during the episode period. A Transfer OASIS (outcome and assessment information set) was completed by skilled nursing on 8/7/25 and 8/17/25 and noted that copies of the transfer summaries were sent to the “Physician” one day after the transfers were documented (8/8/25 and 8/18/25). Additional review of records noted a Transfer Discharge OASIS dated 9/2/25 with marked boxes that the “Inpatient receiving facility” and the “Physician” were sent a transfer summary on 9/3/25. There is no documented evidence that the summaries were forwarded to the physician within 2 days of the date(s) of transfer or 5 days of the date of discharge. During an interview on 3/5/26 at 2:15 PM with the Agency administrator (Staff-A) the above findings were reviewed. Staff-A explained that transfer and discharge summaries are sent out via fax. Staff-A shared a document of the agency’s record keeping of transfer and discharge summaries being sent out. The record did not include who the summaries were sent to. During the interview Staff-A continued to search in the archived faxes for evidence that the transfer summaries were forwarded to the physician and announced, “One was sent out on 8/21/25, the 5th day”. Noted that is outside the requirement of the 2 business days on which the agency is to send physicians the transfer summary. Staff-A acknowledged the findings above that the agency failed to provide documented evidence that the transfer and discharge summaries were sent to the physician within the required timeframes, which did not meet agency expectations or their policy referenced below. A review of agency policy titled “Discharge Planning, Discharge Summary and Discharge OASIS”, (undated), revealed … “All discharge summaries shall be sent to the patient’s physician within 5 days of the patient’s discharge from services”. Patient #1 (P-1)'s start of care (SOC) was 4/21/25 with diagnoses that included End Stage Heart Failure and Abnormal Gait. During the clinical record review on 3/2/26 at 11:45 a.m., it was noted that the Physical Therapist (PT) discharged P-1 from the agency's services on June 4, 2025. The Administrator (Staff-A) reviewed the above findings during an interview on 3/5/26 at 9:55 a.m. and presented a document which gave a date in which the Physician was "notified." Upon further review, there was no documented evidence that a PT Discharge Summary was forwarded to the Physician within 5 days of the date of discharge. P-2's SOC was 1/27/26 with a diagnosis of Idiopathic Progressive Neuropathy. During the record review on 3/2/26 at 2:40 p.m., it was noted that the patient was ordered to receive Skilled Nursing (SN) and PT services. The patient was discharged from SN services on 2/24/26. Upon further review, there was no documented evidence that a SN discharge Summary was forwarded to the Physician within 5 days of the date of discharge. Staff-A reviewed and acknowledged the above findings during an interview on 3/5/26 at 10:05 a.m.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all directly employed staff, regularly utilized contracted staff and all 11 patients actively serviced by this Agency in the event of a facility emergency or disaster (E0004; failed to ensure their Emergency Preparedness policies and procedures were reviewed and updated at least every 2 years, resulting in the Agency's inability to ensure staff actions during an emergency aligned with current practices and guidelines. These practices could negatively affect the health and safety of the agency's 11 current patients in the event of an agency-based emergency or community disaster (E0013); failed to provide documented evidence that all staff employed by this Agency, including contracted staff and volunteers as appropriate, received initial and ongoing training in emergency preparedness policies and procedures; and failed to maintain documentation of trainings, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services (E0037); failed to provide documentation for the required community/facility based full-scale exercises, from an all hazards approach, nor any documentation of an actual event that would qualify as a test of the emergency plan since its initiation in 2009, resulting in the potential to affect all patients and staff, in the event staff is not properly prepared for an emergency (E0039). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all directly employed staff, regularly utilized contracted staff and all 11 patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 2/9/23 a review of the Agency's Emergency Preparedness documents was conducted with the Administrator (Adm #1) and Alternate Clinical Manager (RN #1). Adm #1 presented a binder titled Emergency Preparedness. Upon review, it was noted that a document titled "Emergency and Disaster Preparedness Plan - Policy/Procedure" was dated 8/1/12. Another document titled "Emergency Preparedness Disaster Plan" was noted to be undated. Adm #1 was asked if this was in fact the Agency EP plan to which she responded, "Yes." It could not be determined if the plan had been updated in accordance with the requirements of this section. Additional documents were provided for review that had missing information and blank spaces such as, "The incident commander, who can be contacted at ____________, must approve all requests for assistance prior to implementation..., The Agency will obtain assistance from the following companies to assist with a surge in patient volume: (This section was left blank). At the top of another page, the information "Home Healthcare, DME, Hospital, Local Emergency Planning Committee... were all left blank. This document was incomplete and failed to provide the needed guidance in the event of an emergency or actual disaster. These findings were reviewed with and acknowledged by Adm #1 and RN #1 at the time of discovery. Adm #1 responded, "We hired a consultant to help with this."

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 ensure their Emergency Preparedness policies and procedures were reviewed and updated at least every 2 years, resulting in the Agency's inability to ensure staff actions during an emergency aligned with current practices and guidelines. These practices could negatively affect the health and safety of the agency's 11 current patients in the event of an agency-based emergency or community disaster. Findings include: The agency's Emergency Preparedness Plan was reviewed with the Administrator (Adm #1) on 2/9/23. During the review, it was noted that the Agency's "Emergency and Disaster Preparedness Plan" Policy/Procedure #:E-410 was dated 8/1/12. There was no indication that the Agency's emergency policies and procedures had been reviewed or updated. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to provide documented evidence that all staff employed by this Agency, including contracted staff and volunteers as appropriate, received initial and ongoing training in emergency preparedness policies and procedures; and failed to maintain documentation of trainings, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 2/9/23 the Agency's Emergency Preparedness documentation was reviewed. Upon review of the documents contained in the binder, there was no documented evidence (content and sign in sheet) that all Agency staff, including contracted staff, had received initial and ongoing training in Emergency Preparedness policies and procedures. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Clinical Manager (RN #1) who were both present during the review. Adm #1 reported, "We discussed it as part of our QAPI (Quality Assessment Performance Improvement) meetings."

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to provide documentation for the required community/facility based full-scale exercises, from an all hazards approach, nor any documentation of an actual event that would qualify as a test of the emergency plan since its initiation in 2009, resulting in the potential to affect all patients and staff, in the event staff is not properly prepared for an emergency. Findings include: On 2/9/23 the Agency's Emergency Preparedness documents were reviewed with the Administrator (Adm #1) present. During the review, it was noted that there was no documented evidence that all staff, including contracted staff had participated in emergency drills as per the requirements of this section. During the review, Adm #1 stated that the drills were part of the discussion within the QAPI (Quality Assessment Performance Improvement) meeting minutes. The QAPI meeting minutes for 2022 were reviewed and revealed the following: 1) Snow storm 12/23/22, staff saw patient a day early, 2 patients were seen on the day of inclement weather... There was no activation of the emergency system and no indication of who participated in the drill. Additionally, there was no follow up analysis to determine the effectiveness of measures taken. The document read, "Each patient during SOC (start of care) had received copies and instructions of the ER (Emergency Response) plan..." 2) Winter disaster drill 2/2/22..., ensuring patients had family or caregiver if staff was unable to reach... Each patient during SOC had received copies and instructions..." There was no activation of the emergency system and no indication of who participated in the drills or any follow up analysis. The Agency failed to conduct drills as per the requirement of this section and failed to maintain documentation of staff participation/attendees as well as a post drill analysis to determine the effectiveness. These findings were reviewed with and acknowledged by the Administrator at the time of discovery.

The following Condition and Standard level deficiencies were identified during a Medicare authorized Recertification survey concurrent with the Vaccine Mandate review and a review of the Emergency Preparedness program requirements, conducted by the Michigan Department of Licensing and Regulatory Affairs on 2/7/23 through 2/10/23 at: VN Home Health Care 28230 Orchard Lake Rd., Suite 215 Farmington Hills, MI 48334 Services Provided: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Medical social Work, Home Health Aide. Records Reviewed: 1 Record with home visit, 2 Discharged records, 4 Records without home visits. (The requirement to observe 3 home visits could not be met due to patient refusal and visit cancelation.) The following Condition level deficiencies were identified: 42 CFR §484.65: Quality Assessment Performance Improvement 42 CFR §484.70: Infection Prevention and Control 42 CFR §484.102: Emergency Preparedness 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).

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 (MR #1) of 1 patient observed during a home visit, was included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided and disciplines that will furnish care, from a total of 7 sampled records reviewed, resulting in a lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs. Findings include: MR #1: The patient's start of care was 1/10/23 with diagnoses that included Low Back Pain, Sciatica, Heart Failure and Diabetes Mellitus. On 2/8/23 at 10:00 a.m., a joint home visit was conducted with the Physical Therapist. During a review of the patient's admission packet, it was noted that there was no calendar of proposed visits to be made by the Physical Therapist. Prior to concluding the visit, the patient inquired of the Therapist, "When will you be coming back." The patient had not been included in the overall planning of care and informed of proposed visits. These findings were reviewed with and acknowledged by the Administrator during an interview on 2/9/23 at 10:27 a.m. who reported, "The disciplines are supposed to be filling the calendars out."

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 observation, interview and record review, the Agency failed to ensure the patient's Skilled Nursing and Home Health Aide needs were adequately met in the patient's home for 1 (MR #1) patient who required Nursing assessments for management of diagnosis of heart failure; and 1 (MR #7) patient who required assistance with grooming and Activities of Daily Living, from a total of 7 sampled records reviewed, resulting in patients not receiving care and services based on their identified needs, poor grooming and the potential for physiological decline and poor patient outcomes. Findings include: MR #1: The patient's start of care (SOC) was 1/10/23 with diagnoses that included Heart Failure, Sciatica and Diabetes Mellitus. During a review of the clinical record on 2/7/23 at 11:40 a.m., it was noted that the plan of care (POC) ordered Physical Therapy (PT) services to be provided. It was also indicated that the patient declined Skilled Nursing (SN) services. During a joint home visit with the Physical Therapist (PT #1) on 2/8/23 at 10:00 a.m., the patient was observed ambulating with use of a walker and wearing an Oxygen cannula at 3 liters. The patient complained of weight gain of 3 plus pound in 3 days in addition to swelling to his lower right ankle. PT #1 observed the patient's swelling, yet was not able to provide advice or teaching on this matter. The patient went on to state that his Physician ordered him to take water pills for swelling and his Cardiologist ordered him to take a different amount, "So to be on the safe side, I just take 3 water pills." This writer inquired of the patient's wife, the rationale for declining the needed nursing services to which she responded, "He (patient) was in Garden City Hospital before and when he came home, they sent a nurse out that we weren't pleased with. We never declined Nursing services from this Agency (VN Home Health) because when we first started care with them, he really needed Nursing services." The patient was then asked if he documented his weights, to which he responded, "No. I didn't write anything down." It was uncertain as to whether the patient weighed himself daily in order to determine the presence of fluid overload. Based on the findings noted during this visit, it was determined that the patient required Nursing services for medical management, medication management and teaching. The Agency failed to ensure the patient's needs were adequately met in the home. These finding were reviewed with and acknowledged by the Administrator (Adm #1) and Assistant Clinical Manager (RN #1) during an interview on 2/9/23 at 10:27 a.m. RN #1 responded, "Skilled Nursing should have been provided." MR #7: The patient's SOC was 1/28/23 with diagnoses that included Lobar Pneumonia, Dehydration and Diabetes Mellitus. During the clinical record review on 2/8/23 at3:45 p.m., it was noted that the referral for home care dated 1/24/23 ordered Occupational Therapy (OT), PT, SN and Home Health Aide services to be provided. Section M1800 of the Initial Comprehensive Assessment documented, "someone must assist with grooming, depends on others to dress, unable to use shower..." At the time of this review, Home Health Aide services had not been provided. These findings were reviewed with and acknowledged by Adm #1 and RN #1 during an interview on 2/9/23 at 3:00 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 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; failed to ensure the Registered Nurse provided oversight of the review process; failed to document the findings of the drug regime review as required and failed to ensure the Physician was notified of potential drug interactions in 5 (MR's # 1, 2, 3, 5, and 6) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: MR #1: The patient's start of care (SOC) was 1/10/23 with diagnoses that included Heart Failure, Lumbago and Sciatica. On 2/7/23 at 11:40 a.m., during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 1/10/23, completed by the Physical Therapist (PT) indicated "Yes - issues found during review." There was no documented evidence that the Registered Nurse (RN) had provided oversight of the drug review that was conducted by the PT, as per this requirement. MR #2: The patient's SOC was 1/31/23 with diagnoses that included Hypertension and Osteoarthritis left shoulder. During the record review on 2/7/23 at 1:05 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 1/31/23, completed by the PT indicated Yes-issues found during review. There was no documented evidence that the RN had provided oversight of the drug review that was conducted by the PT, as per this requirement. MR #3: The patient's SOC was 12/1/22 with diagnoses that included congestive Heart Failure and Ischemic Cardiomyopathy. During the record review on 2/7/23 at 2:30 p.m., section M2001 of the Comprehensive Assessment dated 12/1/22 indicated "No issues found during review." The patient's 11 prescribed medication were entered in "Drugs.com" (online drug interaction checker) and revealed 2 major drug to drug interactions and 10 moderate drug to drug interactions. There was no documented evidence that the RN provided oversight of the drug review that was conducted by the PT. MR #5: The patient's SOC was 1/7/23 with diagnoses that included Hyponatremia and Pain Left Hip. During the drug review on 2/8/23 at 1:00 p.m., section M2001 of the Comprehensive Assessment indicated No issues found during review. The Medication Profile was signed by the Alternate Clinical Manager (RN #1) and stated, "I have reviewed all the listed medications for potential adverse effects..." The Agency's "Drug-Drug Interactions" report, utilizing the Agency's Electronic Medical Record (EMR) system, revealed 1 Major drug to drug interaction and 13 Moderate drug to drug interactions. There was no evidence that comprehensive assessment included a review of all the patient's medications to ascertain any untoward medication interactions. MR #6: The patient's SOC was 1/16/23 with diagnoses that included Fractured left Femur and Displaced Hip Replacement. During the record review on 2/8/23 at 2:55 p.m., section M2001 of the comprehensive assessment indicated Yes-Issues found during review. There was no documentation of what issues had been identified or that the Physician had been notified of the findings. The Agency's Drug-Drug Interactions report, utilizing the Agency's EMR system, revealed 3 Major drug to drug interactions and 12 Moderate drug to drug interactions. The Agency failed to ensure the comprehensive assessment included a review of all the patient's medications to ascertain any untoward interactions. The deficient findings identified in the above records were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Clinical Manager (R #1) during an interview on 2/9/23 at 10:45 a.m.

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 and objectively measurable goals specific to the needs of the patient for 4 (MR's #1, 4, 5, 7) records, from a total of 7 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: MR #1: The patient's start of care (SOC) was 1/10/23 with diagnoses that included Heart Failure, Lumbago, Sciatica and Diabetes Mellitus. The plan of care (POC) ordered Physical Therapy (PT) services to be provided. During the clinical record review on 2/7/23 at 11:40 a.m., it was noted that the POC failed to include teaching and monitoring of the patent's weight, reportable weight parameters in which to notify the Physician and failed to include measurable goals related to the patient's diagnosis of Heart Failure. MR #4: The patient's SOC was 6/29/22 with diagnoses that included Hypertensive Heart Disease with heart Failure, Diabetes Mellitus and Stage III Chronic Kidney disease. The POC ordered Skilled Nursing (SN) and PT services to be provided. There was no duration noted in which SN services were to be provided. During the record review on 2/7/23 at 3:50 p.m., it was noted that the POC failed to include interventions, reportable parameters and axxociated goals to address the above diagnoses. MR #5: The patient's SOC was 1/7/23 with diagnoses that included Hyponatremia, COPD (Chronic Obstructive Pulmonary Disease) and Pin left Hip. The POC ordered SN and PT services to be provided. During the clinical record review on 2/8/2 at 1:00 p.m., it was noted that the patient had an additional diagnosis of Urinary Retention and had an indwelling urinary catheter (Foley). The POC failed to mention the presence of the Foley catheter. Additionally, there were no orders that indicated how often the catheter was to be changed, signs to report, catheter care, patient/caregiver teaching and measurable goals. MR #7: The patient's SOC was 1/28/23 wit diagnoses that included Lobar Pneumonia, Dehydration and Diabetes Mellitus. The POC ordered SN, PT and Occupation Therapy (OT) services to be provided. During the clinical record review on 2/8/23 at 3:45 p.m., it was noted that the referral for home care dated 1/24/23 ordered Home Health Aide (HHa) services to be provided also. The POC did not mention the need for HHa services. Additionally, the referral instructed on the need to monitor weight changes and monitor edema. The POC failed to include these interventions or any interventions with reportable parameters and measurable goals that addressed the identified diagnoses. The findings identified in the above records were reviewed with and confirmed by the Administrator (Adm #1) and Alternate Clinical Manger (RN #1) during an interview on 2/9/23 at 10:35 a.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 observation, interview and record review, the Agency's Skilled disciplines failed to ensure the Physician was promptly notified of a change in condition in 1 (MR #1) patient diagnosed with heart disease with increased weight gain and; 1 (MR #4) patient with increased pain levels, from a total of 7 sampled records reviewed, resulting in unrelieved pain and the potential for physiological decline, worsening of condition and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 1/10/23 with diagnoses that included Heart Failure, Sciatica and Diabetes Mellitus. During a review of the clinical record on 2/7/23 at 11:40 a.m., it was noted that the plan of care (POC) ordered Physical Therapy (PT) services to be provided. On 2/8/23 at 10:00 a.m., during a joint home visit with the Physical Therapist (PT #1), the patient was observed ambulating with use of a walker and wearing an Oxygen cannula at 3 liters. The patient complained of weight gain of 3 plus pounds in 3 days in addition to swelling to his lower right ankle. PT #1 observed the patient's swelling, yet was not able to provide advice or teaching on this matter. Swelling was also observed by this writer. The patient went on to state that his Physician ordered him to take a certain amount of water pills for swelling and his Cardiologist ordered him to take a different amount, "So to be on the safe side, I just take 3 water pills." This writer asked the patient if he documented any of his weights, to which he responded, "No. I didn't write anything down." It was uncertain as to whether the patient weighed himself daily in order to determine the presence of fluid overload. Additional review of the clinical record revealed that there was no documented evidence that the Physician had been promptly notified on the status of the patient by the end of the survey. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Clinical Manager (RN #1) during an interview on 2/9/23 at 10:30 a.m. MR #4: The patient's SOC was 6/29/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure Chronic Kidney Disease and Diabetic Mellitus. During the record review on 2/7/23 at 3:50 p.m., it was noted that the POC ordered Skilled Nursing (SN) and PT services to be provided. The POC instructed that the Physician be notified if the patient experienced pain levels greater than 4/10. The record reflected the patient experienced 6/10 on 7/4/22, 6/10 on 7/9/22, 5/10 (SN) and 6/10 (PT) on 7/25/22. Further review revealed that thee was no documented evidence that the Physician had been promptly notified in accordance with the POC and Physician's orders. These findings were reviewed with and acknowledged by Adm #1 and RN #1 during an interview on 2/9/23 at 10:30 a.m.

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 2/7/23 at 10:30 a.m., the Agency's Admission packet was requested and 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 and Alternate Clinical Manager during an interview on 2/9/23 at 10:27 a.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 interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze it's quality indicators in order to assess processes of care and services for calendar year 2021, resulting in the inability to determine the scope of services provided and the potential unmet care needs for all patients currently serviced by this Agency (G642); failed to ensure that the collected data was used to monitor the effectiveness and safety of services provided with opportunities for improvement; and failed to ensure the Governing Body approved the program's frequency and detail of data collection, resulting in the potential for poor patient outcomes for all patients currently serviced and the Agency's 88 patients admitted in the past year (G644); failed to develop a Quality Assessment Performance Improvement program that documented the quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2021 and 2022 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance (G658); the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 11 patients currently receiving services and all 88 patients admitted over the past year (G660). 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 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 interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze it's quality indicators in order to assess processes of care and services for calendar year 2021, resulting in the inability to determine the scope of services provided and the potential unmet care needs for all patients currently serviced by this agency. Findings include: Upon review of the Agency's Quality Assessment Performance Improvement (QAPI) data with Adm #1, it was noted that there was no data available to review for the calendar year 2021 that showed the Agency's efforts to measure, track and analyze indicators in order to determine if care and services have been provided safely and appropriately. These findings were reviewed with and confirmed by Adm #1 at the time of discovery.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the collected data was used to monitor the effectiveness and safety of services provided with opportunities for improvement; and failed to ensure the Governing Body approved the program's frequency and detail of data collection, resulting in the potential for poor patient outcomes for all patients currently serviced and the Agency's 88 patients admitted in the past year. Findings include: On 2/9/23, the Administrator (Adm #1) was asked for permission to review the Agency's QAPI (Quality Assessment Performance Improvement) data for the 2021 and 2022 calendar years. Upon receipt and review of of the requested documents, there was no data available for review for the 2021 calendar year. Of the data reviewed for the year of 2022, there was no indication that services provided were monitored for effectiveness and safety of services provided. Additionally, there was no evidence that the Governing Body approved the data collection, as there was no data collection available for the calendar year 2021. These findings were reviewed with and acknowledged by Adm #1 and the Alternate Clinical Manager (RN #1) who were both present during the review. RN #1 acknowledged she had not been part of the Agency's QAPI program during the 2021 calendar year and could offer response regarding the missing data collection.

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 interview, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2021 and 2022 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: On 2/9/23, the Agency's QAPI (Quality Assessment Performance Improvement) data was reviewed with the Administrator (Adm #1) and Alternate Clinical Manager (RN #1). Of the requested data, only 2022 data had been provided. There was no evidence of any sustained Performance Improvement Projects (PIP) that had been conducted in the 2021 calendar year and monitored throughout with measurable progress achieved. Review of the 2022 PIPs failed to reflect on previous performance of the Agency's services and operations. Additionally, there was no current data presented that reflected the Agency's efforts to monitor the effectiveness of PIPs for the 2022 calendar year. The Agency failed to ensure that at least one PIP was either in development, on-going or completed each calendar year as per the requirements of this section. These findings were reviewed with and acknowledged by Adm #1 and RN #1 at the time of discovery.

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 record review and interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 11 patients currently receiving services and all 88 patients admitted over the past year. Findings include: On 2/9/23, the Agency's Administrator (Adm #1) was asked for permission to review the Agency's QAPI (Quality Assessment Performance Improvement) for the calendar years of 2021 and 2022. Adm #1 only provided data for 2022 which primarily focused on falls, however, was unable to provide any 2021 data. There was no indication that the Governing Body provided oversight to ensure the Agency had an ongoing program for quality improvement and patient safety. These findings were reviewed with and acknowledged by Adm #1 and the Alternate Clinical Manager (RN #1). When queried as to the whereabouts of the 2021 QAPI data, RN #1 stated she was not aware of any other data collection and that she (RN #1) only became involved with QAPI in 2022.

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 interview and record review, the Agency failed to maintain a coordinated agency-wide program for the surveillance, identification, and prevention of diseases; and failed to develop a method of screening all staff employed by this Agency, including field staff who were granted clinical privileges, resulting in the potential for the development, and spread of a contagious viral infection between agency staff and all 11 patients currently serviced by this Agency (G684); failed to provide documented evidence that Infection Control in-services and education had been provided to all staff employed by this Agency, including contracted staff, resulting in the potential for the development and spread of the infection to staff and all 11 patients currently serviced by this agency (G686); failed to establish Vaccine protocol written policies and procedures to ensure that all staff are fully vaccinated against the Covid-19 novel virus, that included (iii) implementation of additional precautions to mitigate the transmission and spread of Covid-19; (vii) a process for tracking/documenting information provided by staff who have requested/been granted an exemption from the Covid-19 requirements; (x) Contingency plans for staff who are not fully vaccinated for Covid-19, resulting in the potential for the development and spread of the Covid-19 virus to staff and all patients serviced by this Agency (G687) 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 §484.70 Infection Prevention and Control.

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 interview and record review, the Agency failed to maintain a coordinated agency-wide program for the surveillance, identification, and prevention of diseases; and failed to develop a method of screening all staff employed by this Agency, including field staff who were granted clinical privileges, resulting in the potential the development, and spread of a contagious viral infection between agency staff and all 11 patients currently serviced by this Agency. Findings include: On 2/9/23, the Agency's Administrator (Adm #1) and Alternate Clinical Manager (RN #1) were queried regarding the process or tool used for screening visitors upon entrance into the agency. Adm #1 reported that office staff were screened whenever in office. When queried about the process for screening visitors, as this writer had not been screened throughout the survey, Adm #1 was unable to respond. When asked if there was a process in place for screening of field staff for potential Covid-19 infections, prior to the provision of care, Adm #1 reported, "We screen them (staff)." Adm #1 presented a spreadsheet with staff names on it. The document reflected the time that staff' self-screened. Upon review, it was noted that Agency staff screened themselves at various times which included times as late as 5:40 p.m., 5:00 p.m., 4:50 p.m., 6:20 p.m., and 5:50 p.m..... There was no process in place to ensure that field staff had been screened for Covid-19 prior to the provision of care and services. These findings were reviewed with and acknowledged by Adm #1 who was present during the review, at the time of discovery.

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 interview and record review, the Agency failed to provide documented evidence that Infection Control in-services and education had been provided to all staff employed by this Agency, including contracted staff, resulting in the potential for the development and spread of the infection to staff and all 11 patients currently serviced by this agency. Findings include: On 2/9/23 at 3:30 p.m., a request was made to review the Agency's in-service education documentation. The Administrator (Adm #1) was observed looking through binders and produced 2 documents and stated, "This is all I could find." Adm #1 presented 2 documents. One of the documents was titled "Equipment, Bag Technique & Hand washing." [sic] The document named the Administrator as having received the education. The second document was titled, "Home Health Aid Annual in service/training Year: April 2022 Part." Due to the presence of Covid-19, CMS has granted wavers to Home Health Agencies regarding the review of the required 12 hours of annual in-service for home health aides. However, as part of the review of the Agency's infection control documentation, it was taken into consideration that this document reflected the Aide was in-serviced on blood borne pathogens, bag technique and donning/doffing/disposal of masks. No information was provided on the details/content of the above in-services. Additionally, Adm #1 was unable to provide documented evidence that all other Agency staff employed by this Agency, including contracted staff had received training/in-service education in Infection Control. As part of this review, Adm #1 presented the Agency's QAPI (Quality Assessment Performance Improvement) meeting minutes dated 6/30/22 which documented, "Surveillance/in-services and training provided: Yes on 100% of staff and patients on an ongoing basis..., handwashing and bag techniques carried out on all active staff annually..." When asked to review evidence of the above surveillance and training provided, Neither Adm #1 nor RN #1 were able to do so. These findings were reviewed with and acknowledged by Adm #1 and the Alternate Clinical Manager at the time of discovery.

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 establish Vaccine protocol written policies and procedures to ensure that all staff are fully vaccinated against the Covid-19 novel virus, that included (iii) implementation of additional precautions to mitigate the transmission and spread of Covid-19; (vii) a process for tracking/documenting information provided by staff who have requested/been granted an exemption from the Covid-19 requirements; (x) Contingency plans for staff who are not fully vaccinated for Covid-19, resulting in the potential for the development and spread of the Covid-19 virus to staff and all patients serviced by this Agency. Findings include: On 2/7/23 at 9:45 a.m., during the Entrance Conference with the Administrator (Adm #1), a request was made to review the Agency's Vaccine Policy. Additional requests were made to review the Agency's Vaccine policy at 12:00 p.m. and 2:07 p.m., at which time, Adm #1 reported, "I can't find it. I know I printed it. It's part of our QAPI (Quality Assessment Performance Improvement) meeting minutes. I copied things from online and made that my policy." Adm #1 was informed of the requirement of this section, yet was still unable to provide the requested policy. Adm #1 could be heard on the telephone requesting a Vaccine policy be sent and stated, "Can you send me a policy?" At 2:50 p.m., Adm #1 informed this writer, "I can't find the Vaccine policy." At 3:18 p.m., Adm #1 retrieved an item from the printer and submitted a document titled "Mandatory Covid-19 Vaccination for Employees." The document focused on staff's initial vaccinations and boosters. The document failed to include information on staff waivers/exemptions, contingency plans, tracking, or any of the other requirements of this section. Further, it was determined that the Agency did not have a Vaccination policy that met the requirements of this section, prior to this writer's request. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure its skilled disciplines performed baseline and ongoing assessments of patient's edema, weights and overall health status of 2 (MR's #4, 7) patients who required specialized monitoring of health status, from a total of 7 sampled records reviewed, resulting in the potential for unidentified, unaddressed health concerns and poor patient outcomes. Findings include: MR #4: The patient's start of care (SOC) was 6/27/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure and Diabetes Mellitus. During the record review on 2/7/23 at 3:50 p.m., it was noted that the Plan of Care (POC) ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The patient's hospital discharge paperwork revealed that the patient was discharged from the hospital on 5/29/22 with a diagnosis of Exacerbation of Congestive Heart Failure (CHF). Further review revealed the patient had a new onset of CHF on 4/16/22. During a review of the clinical record, there was no measurement of edema noted in the SN visit notes. Additionally, there was no measurement of the patient's oxygen saturation noted within the PT notes. The skilled disciplines failed to performed the assessments required for the above diagnoses and in accordance with professional standards of practice. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Alternate Clinical Manger (RN #1) during an interview on 2/9/23 at 10:40 a.m. MR #7: The patient's SOC was 1/28/23 with diagnoses that included Lobar Pneumonia and Diabetes Mellitus. During the record review on 2/8/23 at 3:45 p.m., it was noted that SN, PT and Occupational Therapy (OT) services were ordered to be provided. The referral for home care dated 1/24/23 documented "Monitor weight changes..., monitor edema..." Further review of the record revealed no documented evidence that the skilled disciplines monitored the patient's weights and edema in accordance with the POC and Physician's orders. These findings were reviewed with and acknowledged by Adm #1 and RN #1 during an interview on 2/9/23 at 10:45 a.m.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the clinical record was completed and included detailed Physical Therapy for 1 (MR #1) record with the ordered services, from a total of 7 sampled records reviewed, resulting in the potential for undocumented, unidentified health concerns, and unmet patient needs. Findings include: MR #1: The patient's start of care was 1/10/23 with diagnoses that included Lumbago, Sciatica, Heart Failure and Diabetes Mellitus. During the record review on 2/7/23 at 11:40 a.m., it was noted that the Plan of Care ordered Physical Therapy (PT #1) services to be provided at a frequency of 2x/wk. x 2 wks., 1x/wk. x 5 wks. Further review revealed no documented visit notes for the weeks of 1/22/23 and 1/29/23. A joint home visit was conducted with the Physical Therapist on 2/8/23 at 10:00 a.m. Upon completion of the visit, PT #1 was queried regarding the submission of visit note and reported, "I usually jot down some notes in my car and enter my notes later." These findings were reviewed with and acknowledged by the Administrator and Alternate Clinical Manager during an interview on 2/9/23 at 10:27 a.m. Adm #1 responded, "They (staff) are supposed to have their notes in within 3 days."

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 record review and interview, the Agency failed to provide documented evidence to support that 1 of 1 Home Health Aide employed by this Agency was trained, qualified and deemed competent, by a Registered Nurse, prior to the provision of care and services to the Agency's patient population, resulting in the potential for the rendering of unsafe care and unmet care needs. Findings include: On 2/9/23 at 2:05 p.m., during a review of the Home Health Aide's (HHa #1 Hired 6/20/16) personnel file with the Alternate Clinical Manger (RN #1) and the Administrator (Adm #1), it was noted that the document titled "Competency Assessment Skills Checklist-Home Health Aide" dated 2/16/22 reflected that HHa #1 conducted a self-Assessment. The section titled "Skill Validation by Preceptor" had "YES" typed in all boxes. There were no dates next to the skill observed, no signatures on the form and no indication if any of the required tasks for this section were observed with an actual or pseudo-patient. When asked if a Competency Evaluation was performed at the time of hire, RN #1 presented another Competency Assessment which indicated "Date completed: 06/20/2016." There was a self-assessment section which was completed by HHa #1. The section titled "Competency validation indicated by preceptors initials and date" was void of the preceptor's initials and dates next to each of the required tasks such as vital signs, bathing toileting, transfer techniques, transfers... Additionally, the form was signed by the Certified Occupational Therapy Assistant and a Physical Therapist. There was no indication that any of the above tasks were supervised by a Registered Nurse in accordance with this requirement. These findings were reviewed with and acknowledged by Adm #1 and RN #1 at the time of discovery.

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 prepared clear written patient care instructions for the Home Health Aide regarding safety precautions and client needs, prior to providing care in 1 (MR #2) of 2 records in which Home Health Aide services were ordered, from a total of 7 sampled records reviewed, resulting in the potential for the provision of unsafe care, unmet care needs and poor patient outcomes. Findings include: MR #2: The patient's start of care was 1/31/23 with a diagnoses that included Essential Hypertension and Osteoarthritis of Left Shoulder. The Plan of Care ordered Home Health Aide services to be provided at a frequency of 1x/wk. x 5 wks. and listed the following: Safety Measures: Diabetic: Do Not Cut Nails, Prone to skin break down, DME: Grab bars, Tub/Shower Bench. Additionally, the Aide Care Plan did not include the patent's diagnoses, diet or allergies. During the clinical record review on 2/7/23 at 1:05 p.m., it was noted that the "Aide Care Plan" dated 1/31/23 was void of the above noted precautions. These findings were reviewed with and acknowledged by the Administrator and Alternate Clinical Manager during an interview on 2/9/23 at 10:27 a.m.