Every finding on record at Mj General LLC D/B/A Meiger Health

The State Agency conducted an unannounced Federal Medicare/ Medicaid Home Health Agency Recertification Survey from 06/11/2024 through 06/25/2024 (except 06/19; 06/20; and 06/21/2024). On the first day of the survey, the Home Health Agency reported that their total active census was 210 patients, and their number of unduplicated admissions for skilled services, during the most recent 12-month period was nine (9) patients. On the last day, the agency reported a total of 213 active patients. The total survey sample size consisted of eight (8) clinical records; including four (4) active record reviews without Home Visits; two (2) active record reviews with Home Visits; 4 closed record reviews for discharged patients; 38 Outcome and Assessment Information Set (OASIS) Validation Reports, and review of 14 personnel records. The surveyor found the Home Health Agency to be in substantial compliance with the requirements for the Emergency Preparedness Program. No deficiencies were cited.

The State Agency conducted an unannounced Federal Medicare/ Medicaid Home Health Agency Recertification Survey from 06/11/2024 through 06/25/2024 (except 06/19; 06/20; and 06/21/2024). On the first day of the survey, the Home Health Agency reported that their total active census was 210 patients, and their number of unduplicated admissions for skilled services, during the most recent 12-month period was nine (9) patients. On the last day, the agency reported a total of 213 active patients. The total survey sample size consisted of eight (8) clinical records; including four (4) active record reviews without Home Visits; two (2) active record reviews with Home Visits; 4 closed record reviews for discharged patients; 38 Outcome and Assessment Information Set (OASIS) Validation Reports, and review of 14 personnel records. During the pre-survey preparation, the surveyor was unable to retrieve any reports that showed the agency’s successful transmission of OASIS data confirmation of encoding and transmission of OASIS data to the CMS system for beneficiaries receiving skilled services. The surveyor cited Standard Level deficiencies based on observations, interviews with agency staff, patients, patients' caregivers, review of clinical records, and the agency's policies. Additionally, the surveyor identified the following condition level deficiencies at 42 CFR Part 484: i. §484.50 Condition of participation: Patient rights. ii. §484.55 Condition of participation: Comprehensive assessment of patients; and iii. §484.60 Condition of participation: Care planning, coordination of services quality of care.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on interview with agency staff, and review of the CMS (Centers for Medicare and Medicaid Systems) iQIES (the Internet Quality Improvement and Evaluation System) Submission Report/ OASIS (Outcome and Assessment Information Set) Agency Final Validation Reports, the agency's clinical staff failed to encode and electronically transmit each completed OASIS assessment directly to the CMS system, within the timely guidelines of 30 days of completing each beneficiary’s assessments, for four (4) of 4 submitted assessment records, for the time periods of 11/09/2023 through 06/18/2024, (Patients # 3, 8, 9 and 10). Findings include… The Home Health Agency was unable to provide its revised policy relative to encoding and transmitting OASIS. i.Submission Date/Time: 04/08/2024 at 17:56:36 [5:57 PM]; Patient #3 Eff Date 04/08/2024 transmitted 06/17/2024> 30 days ii.Submission Date/Time: 06/12/2024 at 16:30:33 [4:31 PM]; Patient #8 Eff Date 11/09/2023 transmitted 06/12/2024> 30 days iv.Submission Date/Time: 06/12/2024 at 15:38:12 [3:38 PM]; Patient #9 Eff Date 04/18/2024 transmitted 06/12/2024 > 30 days v.Submission Date/Time: 06/12/2024 at 16:02:15 [4:02 PM]; Patient #10 Eff Date 12/01/2023 transmitted 06/12/2024 > 30 days The Home Health Agency failed to report OASIS data for patients admitted to the agency and receiving skilled services in a timely manner, as evidenced by the aforementioned OASIS Final Validation Reports. Additionally, the agency's staff failed to collect, encode, and transmit OASIS data for Patient #2, a Medicaid patient aged over 18 and receiving skilled services. Employees#1, and #5, acknowledged and confirmed the findings during a face-to-face interview on 06/24/2024 at approximately 12:15 PM.

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to provide the patient or the patient’s representative with notice of their rights, consistent with the standards under this condition for one (1) of one (1) patient, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Patient #2, Employees # 1, 2, and 13. After obtaining signatures on the ‘Consent For Home Visit’ form, the surveyor gave the original version of the signed ‘Consent For Home Visit’ form to the patient’s mother and advised that all relevant home health forms and written information received would best be kept in the same place, such as the admission packet or folder. The surveyor then asked the caregiver’s permission to review the patient’s information packet including the written information that the agency provided at the start of care. In response to the surveyor’s request, the patient’s mother replied that she did not receive a folder from the agency and does not have one in the home. For clarification, the surveyor explained to the caregiver that the agency’s admission packet, or folder should contain copies of all documents that she signed, from the first time the agency’s clinician visited the home to conduct the initial assessment visit for the purpose of determining the patient’s immediate care and support needs. During the home visit, the patient’s mother, who is the patient’s representative, stated that she did not receive a Patient Handbook and was unable to present one to the surveyor upon request. Employees # 1, 2, and 13 acknowledged the caregiver’s statement and Employee #1 promised to ensure the package will be expedited to the residence of the patient and caregiver. A review of the agency’s Patient Handbook showed the home folder should contain the following documents i. Service type agreement; ii. Rights of and Responsibilities of the patient; iii. Release of medical record consent form; iv. Abuse, neglect and exploitation; v. Family disaster plan; vi. Notice of privacy practice; and vii. Patient handbook. On 07/02/2024 the surveyor received an electronic mail confirmation that the Employee #1 hand delivered home folder to the caregiver later on the same day of the home visit, 06/13/24 at approximately 6:30 pm.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to conduct an the initial evaluation visit, and failed to provide the patient’s caregiver the following information, in advance of furnishing care for one (1) of one patient, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Patient #2, Employees # 1, 2, and 13. Following the surveyor’s explanation of the survey process, the ‘Consent For Home Visit’ form (Form CMS-36), reason for the visit, and mom signed the form as the representative of the patient/ beneficiary, Patient #2 also signed the form behind her Mom’s signature, authorizing the visit. After obtaining signatures on the ‘Consent For Home Visit’ form, the surveyor gave the original version of the signed ‘Consent For Home Visit’ form to the caregiver and advised that all relevant home health forms and written information received would best be kept in the same place, such as the admission packet or folder. The surveyor then asked the caregiver’s permission to review the patient’s information packet including the written information that the agency provided at the start of care and outdated on subsequent visits. In response to the surveyor’s request, the patient’s mother replied that she did not receive a folder from the agency. For clarification, the surveyor explained to the caregiver that the agency’s admission packet, or folder should contain copies of all documents that she signed, from the first time the agency’s clinician visited the home to conduct the initial assessment visit for the purpose of determining the patient’s immediate care and support needs. The patient’s mother insisted that she did not receive a folder from the agency. The surveyor questioned the mom about her knowledge of the process that she would follow to report a complaint if she had one, she replied that she did not. Employees # 1, 2, and 13 acknowledged the caregiver’s statement and Employee #1 promised to ensure the package will be expedited to the residence of the patient and caregiver. On 07/02/2024 the surveyor received an electronic mail confirmation that the administrator hand delivered home folder to the caregiver later on the same day of the home visit, 06/13/24 at approximately 6:30 pm. Cross Reference G0418; G0422; and G0436.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to ensure the patient and the patient’s legal representative received a copy of the notice of rights and responsibilities for one (1) of one (1) patient, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Patient #2, Employees # 1, 2, and 13. Following the surveyor’s explanation of the survey process, the ‘Consent For Home Visit’ form (Form CMS-36), reason for the visit, and mom signed the form as the representative of the patient/ beneficiary, Patient #2 also signed the form behind her Mom’s signature, authorizing the visit. After obtaining signatures on the ‘Consent For Home Visit’ form, the surveyor gave the original version of the signed ‘Consent For Home Visit’ form to the caregiver and advised that all relevant home health forms and written information received would best be kept in the same place, such as the admission packet or folder. The surveyor then asked the caregiver’s permission to review the patient’s information packet including the written information that the agency provided at the start of care and outdated on subsequent visits. In response to the surveyor’s request, the patient’s mother replied that she did not receive a folder from the agency and does not have one in the home. For clarification, the surveyor explained to the caregiver that the agency’s admission packet, or folder should contain copies of all documents that she signed, from the first time the agency’s clinician visited the home to conduct the initial assessment visit for the purpose of determining the patient’s immediate care and support needs. The patient’s mother insisted that she did not receive a folder from the agency. The surveyor questioned the mom about her knowledge of the process that she would follow to report a complaint if she had one, she replied that she did not. Employees # 1, 2, and 13 acknowledged the caregiver’s statement and Employee #1 promised to ensure the package will be expedited to the residence of the patient and caregiver. A review of the agency’s Patient Handbook showed the home folder should contain the following documents i. Service type agreement; ii. Rights of and Responsibilities of the patient; iii. Release of medical record consent form; iv. Abuse, neglect and exploitation; v. Family disaster plan; vi. Notice of privacy practice; and vii. Patient handbook. On 07/02/2024 the surveyor received an electronic mail confirmation that the Employee #1 hand delivered home folder to the caregiver later on the same day of the home visit, 06/13/24 at approximately 6:30 pm. Cross Reference G0410; G0422; and G0436.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to provide written notice of the patient’s rights and responsibilities to the patient and the patient’s legal representative within four (4) business days of the initial evaluation visit for one (1) of one (1) patient, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Patient #2, Employees # 1, 2, and 13. Following the surveyor’s explanation of the survey process, the ‘Consent For Home Visit’ form (Form CMS-36), reason for the visit, and mom signed the form as the representative of the patient/ beneficiary, Patient #2 also signed the form behind her Mom’s signature, authorizing the visit. After obtaining signatures on the ‘Consent For Home Visit’ form, the surveyor gave the original version of the signed ‘Consent For Home Visit’ form to the caregiver and advised that all relevant home health forms and written information received would best be kept in the same place, such as the admission packet or folder. The surveyor then asked the caregiver’s permission to review the patient’s information packet including the written information that the agency provided at the start of care and outdated on subsequent visits. In response to the surveyor’s request, the patient’s mother replied that she did not receive a folder from the agency and does not have one in the home. For clarification, the surveyor explained to the caregiver that the agency’s admission packet, or folder should contain copies of all documents that she signed, from the first time the agency’s clinician visited the home to conduct the initial assessment visit for the purpose of determining the patient’s immediate care and support needs. The patient’s mother insisted that she did not receive a folder from the agency. The surveyor questioned the mom about her knowledge of the process that she would follow to report a complaint if she had one, she replied that she did not. Employees # 1, 2, and 13 acknowledged the caregiver’s statement and Employee #1 promised to ensure the package will be expedited to the residence of the patient and caregiver. A review of the agency’s Patient Handbook showed the home folder should contain the following documents i. Service type agreement; ii. Rights of and Responsibilities of the patient; iii. Release of medical record consent form; iv. Abuse, neglect and exploitation; v. Family disaster plan; vi. Notice of privacy practice; and vii. Patient handbook. On 07/02/2024 the surveyor received an electronic mail confirmation that the Employee #1 hand delivered home folder to the caregiver later on the same day of the home visit, 06/13/24 at approximately 6:30 pm. Cross Reference G0410; G0418; and G0436.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to ensure that the patient receives all services outlined in the plan of care for one (1) of one (1) patient, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Patient #2, Employees # 1, 2, and 13. In response to the surveyor’s question about her satisfaction with the services the agency provided to Patient #1, the patient’s mother stated that she did not like the manner displayed by Employee #14, OT (Occupational Therapist). Patient #1’s mother stated that Employee #14 did not return to the home to provide additional services and did not contact her after the first visit. The surveyor conducted a review of Patient # 2’s clinical record on 06/14/2024 at approximately 11:00 AM that showed Employee #13, Physical Therapist prepared a ‘Service Type Agreement’/ ‘Consent For Services’ form dated 01/16/2024 that included the plan for Occupational Therapy weekly, two (2) hours per day, five (5) days per week for 12 months; and Physical Therapy weekly, one (1) hour per day, two (2) days per week for eight (8) months. Additional review of the clinical record showed Employee #14, prepared an ‘OT Start of Care Evaluation’ form dated 01/16/2024. Further review of the clinical record showed no additional ‘OT Visit Notes’; Missed visit notes, or Discharge notes after 01/16/2024. Employees # 1, 2, and 13 acknowledged the caregiver’s statement during the home visit on 06/13/2024 at approximately 2:50 PM, and Employees #1 and 5 acknowledged the findings following the clinical record review. Cross Reference G0410; G0418; and G0422.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on interviews with agency staff, review of clinical records and the agency's policy, the Home Health Agency failed to ensure the registered nurse conducted an effective initial assessment visit (G514); failed to ensure the agency’s rehabilitation skilled professional conducted and documented an initial assessment visit to determine the patient’s immediate care and support needs (G516); failed to document complete comprehensive assessments consistent with patients’ immediate needs, no later than five (5) calendar days after the start of care (G520); failed to incorporate the use of the current version of the Outcome and Assessment Information Set (OASIS) items in their own comprehensive assessment (G542); and failed to document updated and revised comprehensive assessments at discharge (G0550). The cumulative effect of these systemic practices resulted in the Home Health Agency's failure to comply with conditions of participation for Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff and patient’s caregiver, the Home Health Agency failed to ensure the registered nurse conducted and documented initial assessment visits to determine patient’s immediate care and support needs for two (2) of 4 clinical records, (Patients #1 and 3). Findings included... Review of the Home Health Agency's policy, reference number CLN.002, titled, "Initial Assessment", did not include the requirement for an initial assessment visit to be conducted by the agency’s registered nurse to determine the patient’s immediate care and support needs for patients receiving only nursing services. a. The surveyor conducted a home visit with Patient #1 on 06/12/2024 at approximately 2:10 PM, in the presence of Employees #15, a Home Health Aide; #9, morning LPN (Licensed Practical Nurse); #6, RN/ Quality Assurance; and Employee #10, the evening LPN. During the home visit, the surveyor observed Patient #1’s head and face with notable asymmetry in the right parietal area, above the right ear. In response to the surveyor’s question regarding her current state of health, Patient #1 stated that she underwent a surgical procedure approximately 2 to 3 years ago for an aneurysm. She stated that during the procedure the surgeon had to remove a piece of her skull to relieve pressure on her brain. She added that she also had a stroke around that time. The surveyor conducted a review of Patient # 1’s clinical record on 06/14/2024 at approximately 2:00 PM that showed a clinician’s note from an Emergency Department dated 03/04/2024 that revealed the patient’s history of present Illness included with Diabetes Mellitus, Hemorrhagic Stroke status post Right-Sided Decompressive Hemicraniectomy followed by “…1/2022 (left-sided weakness and facial droop), respiratory failure s/p tracheostomy…” The clinical record contained another report titled ‘ED Clinical Summary’ dated 03/04/2024 that revealed “… Weight Dosing 113.6 kg [kilograms] 03/04/2024 equivalent to approximately 250.4 pounds, and ‘Active Problems’ included Morbid Obesity. The surveyor conducted a review of Patient # 1’s Plan of Care with a Start of Care date of 2/29/2024, and a Recertification Period from 6/29/2024 through 8/27/2024. The patient's diagnoses on the Plan of Care included Hemiplegia Affecting Left Nondominant Side, Hypertension, Tracheostomy status, Epilepsy and Recurrent Seizures, Gastro-esophageal Reflux, and Iron Deficiency Anemia. The Plan of Care did not include all diagnoses; Diabetes Mellitus, Hemorrhagic Stroke status post Right-Sided Decompressive Hemicraniectomy followed by “…1/2022 (left-sided weakness and facial droop), and Morbid Obesity. Physician’s orders on the Plan of Care directed physical therapy services weekly, for one (1) hour each day, three (3) days per week for two (2) months. Additionally, the orders directed private duty nursing weekly; 24 hours per day, seven (7) days per week, for 12 months, and Personal Care Attendant [Aide] weekly, 17 hours per day, seven (7) days per week, for 12 months. The clinical record did not include documented evidence of an initial assessment visit to determine the patient’s immediate care and support needs. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings on 06/24/2024 at approximately 11:20 AM. b. The surveyor conducted a review of Patient #3’s clinical record on 06/18/2024 at approximately 11:30 AM that showed a clinic note from the primary care physician's office dated 02/20/2024. Diagnoses in the clinic note revealed Chronic Pulmonary Aspiration, Bilateral Wheezing, Cavitary Lung Disease, Morbid Obesity, Wheelchair Dependence, Chronic Contractures of Upper Extremities Exophthalmos, and showed that patient would occasionally pull at her own eyes. Neurological status showed the patient was nonverbal and did not follow commands. Physician’ Orders on the Plan of Care directed private duty nursing; 24 hours per day, seven (7) days per week for 60 days for G-Tube management and medication administration. Physician’s orders on the Plan of Care directed physical therapy services weekly, for one (1) hour each day, three (3) days per week for two (2) months. Additionally, the orders directed private duty nursing weekly; 24 hours per day, seven (7) days per week, for 12 months, and Personal Care Attendant [Aide] weekly, 17 hours per day, seven (7) days per week, for 12 months. The clinical record did not include documented evidence of an initial assessment visit to determine the patient’s immediate care and support needs. The surveyor conducted a face-to-face interview with Employees #1, and #5. They both acknowledged and confirmed the findings on 06/24/2024 at approximately 11:20 AM. Cross Reference G0516; G0520; G0542; and G0550.

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, and if the need for that service establishes program eligibility, the initial assessment visit may be made by the appropriate rehabilitation skilled professional. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff and caregiver, the agency’s rehabilitation skilled professional failed to document an initial assessment visit to determine the patient’s immediate care and support needs for one (1) of five (5) clinical records of patients receiving skilled services, (Patient #2). Findings included... The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. During the home visit, the surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Employees # 1, 2, and 13. In response to the surveyor’s query about the services that agency staff provide to Patient #2, she stated that they provide physical and occupational services. The caregiver stated that the physical therapy sessions did help improve the patient’s ability to move around the home safely and added that she observed the patient is more active than she was before. She further explained that Patient#2 is unable to run but observed that she was able to move quicker than she did before. The surveyor conducted a review of Patient # 2’s clinical record on 06/14/2024 at approximately 11:00 AM that showed a current Plan of Care with a Start of Care date of 01/11/2024, and an initial annual Certification Period from 01/11/2024 through 12/31/2024. Plan of Care item #11 titled ‘Diagnosis’ showed Developmental Disorder of Speech and Language. Further review of the clinical record showed Patient #2 received rehabilitation therapy services only, including occupational and physical therapy. Physician’s orders directed physical therapy services for therapeutic strengthening exercise, mobility training exercise, transfer training exercise, range of motion exercise, balance training exercise, positioning exercises, gait training exercise, and safety precautions for one hour each day, two days per week for eight weeks. Additionally, the orders directed occupational therapy services for upper body strength one hour each day, two days per week for eight weeks. The clinical record did not include documented evidence of an initial assessment visit to determine the patient’s immediate care and support needs. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings on 06/17/2024 at approximately 11:20 AM. Cross Reference G0514; G0520; G0542; and G0550.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff and patient, the Home Health Agency failed to document complete comprehensive assessments consistent with patients’ immediate needs, within five (5) calendar days for one (1) of three (3) clinical records, (Patient #1). Findings included... Review of the Home Health Agency's policy, reference number CLN.046, titled, "Comprehensive Assessment", shows a registered nurse must complete the comprehensive assessment. The surveyor conducted a review of Patient #1’s clinical record on 06/14/2024 at approximately 2:00 PM that showed review of clinical record showed Employee #2, RN, Clinical Manager prepared a clinical assessment titled NURSING ASSESSMENT ADULT START OF CARE and dated 02/29/2024 showed the following: i. The assessment item questioned “If patient living alone, in consideration of patient condition, does this pose a risk factor? The response showed a check mark corresponding with “No”, and showed no additional comments ii. Assessment item titled ‘MEDICAL DIAGNOSIS’ included Hemiplegia Affecting Left Nondominant Side, Tracheostomy Status, Gastro-Esophageal Reflux Disease, Iron Deficiency Anemia, Dry Mouth, and Hypertension. The listing of diagnoses did not include all associated with prescribed medications with specific indications. iii. Assessment item titled ‘MEDICATION PROFILE’ contained medications with the following associated indications of Bronchospasm, Chest congestion; and the medication, Acetaminophen / Codeine for Moderate Pain. iv. Assessment item titled ‘REVIEW OF SYSTEM’ showed the patient’s Neck; Within normal limits and did not include the Tracheostomy tube in situ. v. Assessment item titled ‘Face’ showed a check mark against ‘Symmetrical’, and did not reflect documented evidence of the Right Parietal concave area to the patient’s head and facial asymmetry the surveyor observed during the home visit in the presence of Employees #6, RN, Quality Assurance Manager ; #9, #10; both LPNs; and #16 Home Health Aide. vi. Assessment item titled ‘Respiratory’ showed check marks against coughing, and a note entry “The client is on 5l [Liters]/ oxygen vii. Tracheostomy showed check marks against Yes’, Uncuffed Tracheostomy Tube, Size: 6.00mm [millimeter], Trach Stoma/Site: Intact viii. Assessment items titled ‘Drainage type’ and ‘Drainage odor’ showed blank spaces and did not include descriptors ix. Assessment item titled ‘COMORBIDITIES AND HEALTH STATUS’ showed that Employee #2 identified and selected the following best descriptions of the patient’s status: More than two (2) hospitalizations in the past six (6) months Taking five (5) or more medications; and Frailty indicators such as weight loss or self-reported exhaustion Other: x. Assessment item titled ‘CAREGIVER OR HOME SUPPORT’ showed the patient lived alone needed assistance, but no caregiver was available xi. Assessment item titled ‘DURABLE MEDICAL EQUIPMENT AND SUPPLIES’ included hospital bed, suctioning machine, trach supplies, diapers, and chucks. The list did not include… xii. Assessment item titled ‘SAFETY MEASURES’ did not include maintenance of patent airway, aspiration precautions, pressure injury prevention AND associated Plans of care for each xiii. Assessment item titled ‘FUNCTIONAL LIMITATIONS’ showed check marks against Paralysis, Bowel / bladder, Endurance, Contracture, and Dyspnea with minimal exertion xiv. Assessment item titled ‘Activities Permitted’ showed check marks against complete bedrest and Transfer bed / chair. The entry included conflicting information. Employees #1, Administrator and #5, the agency's Director of Compliance acknowledged and confirmed the findings on 06/24/2024 at approximately 12:30 PM. Cross Reference G0514; G0516; G0542; and G0550.

Incorporate OASIS items CFR(s): 484.55(c)(8) Incorporation of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language and groupings of the OASIS items, as specified by the Secretary. The OASIS data items determined by the Secretary must include: clinical record items, demographics and patient history, living arrangements, supportive assistance, sensory status, integumentary status, respiratory status, elimination status, neuro/emotional/behavioral status, activities of daily living, medications, equipment management, emergent care, and data items collected at inpatient facility admission or discharge only. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff and patient’s caregiver, the Home Health Agency failed to incorporate the use of the current version of the Outcome and Assessment Information Set (OASIS) items in their own comprehensive assessment in two (2) of 2 clinical records for patients receiving skilled services, (Patients #1 and 3). Findings included... A review of the OASIS (Outcome and Assessment Information Set) -E Guidance Manual, updated 01/01/2024 by CMS (Centers for Medicare and Medicaid Systems) stipulates “… OASIS data are collected as part of the comprehensive assessment required by the Medicare Conditions of Participation. OASIS is not intended to represent a comprehensive assessment in and of itself. HHAs are expected to incorporate OASIS items into their comprehensive assessment documentation and follow their own assessment policies and procedures. Agencies may rearrange OASIS item sequence in a way that permits logical ordering within their own forms and electronic records, as long as the actual item content, and OASIS number and formatting remain the same, and maintaining the same skip logic. The comprehensive assessment forms the basis of the physician-ordered Plan of Care…” Review of the Home Health Agency's policy, reference number CLN.046, titled, "Comprehensive Assessment", shows the comprehensive assessment must accurately reflect the patient's status and must include incorporation of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language, and groupings, of the OASIS items, as specified by the Secretary. a. The surveyor conducted a review of Patient # 1’s clinical record on 06/14/2024 at approximately 2:00 PM that showed a Plan of Care with a Start of Care date of 2/29/2024, and a Recertification Period from 6/29/2024 through 8/27/2024. The patient's diagnoses on the Plan of Care included Hemiplegia Affecting Left Nondominant Side, Hypertension, Tracheostomy status, Epilepsy and Recurrent Seizures, Gastro-esophageal Reflux, and Iron Deficiency Anemia. Patient #1 received private duty skilled nursing services 24 hours a day, 7 days a week for continuous management of airway, gastrostomy tube feedings and medication administration. Additional review of Patient #1’s clinical record showed Employee #2, RN, Clinical Manager prepared a clinical assessment titled ‘Nursing Assessment Adult Start of Care’ dated 02/29/2024. The assessment did not include OASIS items. Additional review of the electronic medical record did not include a comprehensive assessment that accurately reflect the patient's status and included OASIS items. On 06/24/ 2024 at approximately 9:30 AM, Employee #1, the Administrator provided a printed untitled document that identified Patient #1’s name and included only OASIS items. The untitled document was not included as a part of the patient’s legal home health agency clinical record. Further review of Patient #1’s electronic medical record did not include a comprehensive assessment with OASIS elements. b. The surveyor conducted a review of Patient #3’s clinical record on 06/18/2024 at approximately 11:30 AM that showed a clinic note from the primary care physician's office dated 02/20/2024. Diagnoses in the clinic note revealed Chronic Pulmonary Aspiration, Bilateral Wheezing, Cavitary Lung Disease, Morbid Obesity, Wheelchair Dependence, Chronic Contractures of Upper Extremities Exophthalmos, showed that Patient #3 would occasionally pull at her own eyes. According to the clinic note, the patient’s neurological status reflected the patient was nonverbal and did not follow commands. Additional review of Patient # 3’s clinical record showed a Plan of Care with a Start of Care date of 04/03/2024, and a Recertification Period from 6/12/2024 through 8/10/2024. Diagnoses on the Plan of Care included Cerebral Palsy, Wheelchair Dependence, Cytomegaloviral Disease, Other Disease of the Lung, Gastrostomy Status, Urinary Incontinence, Epilepsy, Scoliosis, Sensorineural Hearing Loss, and Wheezing. Further review of Patient #3’s electronic medical record did not include a comprehensive assessment with OASIS elements. Continued review of Patient #3’s clinical record showed Employee #15, RN, prepared a clinical assessment titled ‘Nursing Assessment Adult Start of Care’ dated 04/04/2024. The assessment did not include OASIS items. Patient #3 received private duty skilled nursing services 24 hours a day, 7 days a week for continuous management of airway, gastrostomy tube feedings and medication administration. Additional review of the electronic medical record did not include a comprehensive assessment that accurately reflect the patient's status and included OASIS items. On 06/24/2024 at approximately 9:30 AM, Employee #1, provided a printed untitled document that identified Patient #3’s name and included only OASIS items. The untitled document was not included as a part of the patient’s legal home health agency clinical record. Also, review of Patient #1’s electronic medical record did not include a comprehensive assessment with OASIS elements. The Home Health Agency's staff failed to incorporate the use of the current version of the OASIS items, into their own comprehensive assessment using the language and groupings of the OASIS items, as specified by the Secretary. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings following the review of the Plan of Care on 06/17/2024 at approximately 1:20 PM. Cross Reference G0514; G0516; G0520; G0550.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interviews with agency staff, review of clinical records and the agency's policy, the agency's clinician failed to document updated and revised comprehensive assessments at discharge, in one (1) of one closed clinical record for a patient discharged from the agency, (Patient #8). Findings included... Review of the Home Health Agency's policy, titled, "Assessment” shows a comprehensive discharge assessment will be completed at discharge for all patients. The surveyor conducted a review of Patient #8's clinical record on 06/25/2024 at approximately 10:30 AM that showed Employee # 13, PT (Physical Therapist), prepared a ‘Physical Therapy Start of Care’ assessment dated 10/09/2023. Additional review of Patient #8's clinical record showed a Plan of Care with a Start of Care date of 09/18/2023, and an Initial Certification Period for skilled services from 09/29/2023 to 09/30/2024. The diagnoses on the current Plan of Care included Hypertension, Fractures, and OA [Osteoarthritis of hip]. Additional review of the Plan of Care showed physician orders directed physical therapy services for residual weakness and gait disturbances following Total Hip Replacement. Further review of the clinical record showed Patient #8 received physical therapy services, and the therapist documented a “Discharge Order” [Discharge Summary] for Patient #8, dated 03/08/2024. The clinical record lacked documented evidence of an updated and revised comprehensive assessment of Patient #8 at discharge. The surveyor conducted a face-to-face interview with Employee#5, the agency’s Director of Compliance who acknowledged and confirmed the findings on 06/24/2024 at approximately 2:20 PM.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to ensure that each individualized plan of care included all required elements (G574), failed to develop an individualized plan of care to ensure review and revision by the physician or allowed practitioner no less frequently than once every 60 days, beginning with the start of care date (G588); and failed to integrate services to assure the identification of patient needs, treatment effectiveness and the coordination of care provided by all disciplines (G606). The cumulative effect of these systemic practices resulted in the Home Health Agency's failure to comply with conditions of participation for Care planning, coordination of services, and quality of care. N/A

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on review of clinical records, the agency's policy, and interview with agency staff and patient’s caregiver, the agency's staff failed to ensure that the patient's Plan of Care was individualized and included all required elements, for two (2) of two clinical records (Patients #1 and 3). Findings included... https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/r23pim.pdf cms.gov “Completion of Form CMS-485” A review of the Provider Manual: Appendix 5, Reporting and Assessment Forms/ Home Health Certification and Plan of Care Instructions titled 'Completion of Form CMS--485', Home Health Certification and Plan of Care directs for completion of item on the Plan of care, "Orders for Discipline and Treatments...The physician must specify the frequency and expected duration of the visits for each discipline...PRN [as needed] visits may be ordered on a plan of care only where they are qualified in a manner that is specific to the patient's potential needs. Both the nature of the services and the number of PRN visits to be permitted for each type of service must be specified. Open-ended, unqualified PRN visits do not constitute physician orders since their nature, nor their frequency is specified..." A review of the Home Health Agency’s undated policy titled “Plan of Care and Verbal Orders” showed that the plan of care shall include but not be limited to pertinent diagnoses, specific disciplines, frequency and duration of services, functional limitations, and safety precautions. a. The surveyor conducted a home visit with Patient #1 on 06/12/2024 at approximately 2:10 PM, in the presence of Employees #15, a Home Health Aide; #9, morning LPN (Licensed Practical Nurse); #6, RN/ Quality Assurance; and Employee #10, the evening LPN. During the home visit, the surveyor observed Patient #1’s head and face with notable asymmetry in the right parietal area, above the right ear. In response to the surveyor’s question regarding her current state of health, Patient #1 stated that she underwent a surgical procedure approximately 2 to 3 years ago for an aneurysm. She stated that during the procedure the surgeon had to remove a piece of her skull to relieve pressure on her brain. She added that she also had a stroke around that time. Additionally, during the home visit, the surveyor observed Patient #1 lying on a hospital bed with a mattress overlay in place beneath, the bedsheet as Employee #10 assisted #15 in changing Patient #1’s position in bed. The surveyor also observed Patient #1with a tracheostomy tube in place and wearing a Trach-color with clear, blue, transparent, corrugated tubing connected to humidified Oxygen at 5 liters per minute continuously. The surveyor conducted a review of Patient # 1’s clinical record on 06/14/2024 at approximately 2:00 PM that showed a clinician’s note from an Emergency Department dated 03/04/2024 that revealed the patient’s history of present Illness included with Diabetes Mellitus, Hemorrhagic Stroke status post Right-Sided Decompressive Hemicraniectomy followed by “…1/2022 (left-sided weakness and facial droop), respiratory failure s/p tracheostomy…” The clinical record contained another report titled ‘ED Clinical Summary’ dated 03/04/2024 that revealed “… Weight Dosing 113.6 kg [kilograms] 03/04/2024 equivalent to approximately 250.4 pounds, and ‘Active Problems’ included Morbid Obesity. The surveyor conducted a review of Patient # 1’s Plan of Care with a Start of Care date of 2/29/2024, and a Recertification Period from 6/29/2024 through 8/27/2024. Plan of Care items #11, #12 and #13, titled ‘Diagnoses’ included Hemiplegia Affecting Left Nondominant Side, Hypertension, Tracheostomy status, Epilepsy and Recurrent Seizures, Gastro-esophageal Reflux, and Iron Deficiency Anemia. i. The aforementioned Plan of Care item designated for diagnoses did not include Diabetes Mellitus, Hemorrhagic Stroke status post Right-Sided Decompressive Hemicraniectomy followed by “…1/2022 (left-sided weakness and facial droop), and Morbid Obesity. ii. Plan of Care item #14 titled DME [Durable Medical Equipment] showed “NONE”, and did not show reference to another section on the Plan of Care that may include essential items for a Tracheostomy dependent patient in the home. a. Suction machine, Suction catheters, tracheostomy supplies such as extra tracheostomy tubes (Specify the type, size), syringe for trach cuff, extra tracheostomy tube ties, Ambu bag or artificial manual breathing unit for bag ventilation of appropriate size, Yankauer suction, blunt end scissors b. Humidification supplies including corrugated tubing, trach collar, oxygen concentrator, and portable oxygen tanks. c. Medicine supplies, nebulizer machine, nebulizer kit with trach collar, medicine syringe d. Pulse oximeter for checking oxygen saturation and monitoring supplies, Oxygen equipment, Oxygen source, Oxygen tubing e. Tracheostomy care supplies including hydrogen peroxide, cotton-tip swabs (non-sterile) like ‘Q-tips’, water-based lubricant, and unsterile procedure gloves. f. Supplies for oral care iii. Plan of Care item # 15, titled ‘Safety Measures’ showed “Fall precaution’ and did not include risk for infection, seizure precautions, airway precautions, aspiration precautions, pressure injury precautions and contractures. Physician orders on the Plan of Care directed Private Duty Nursing, 24 hours per day, seven (7) days per week for 12 months; Personal Care “Attendant” [Aide], 17 hours per day, 7 days per week for 12 months; and Physical Therapy: 1 (one) hour per day, 3 days per week for two (2) months. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings following the review of the Plan of Care on 06/17/2024 at approximately 1:20 PM. b. The surveyor conducted a review of Patient #3’s clinical record on 06/18/2024 at approximately 11:30 AM that showed a clinic note from the primary care physician's office dated 02/20/2024. Diagnoses in the clinic note revealed Chronic Pulmonary Aspiration, Bilateral Wheezing, Cavitary Lung Disease, Morbid Obesity, Wheelchair Dependence, Chronic Contractures of Upper Extremities, Exophthalmos, showed that Patient #3 would occasionally pull at her own eyes. According to the clinic note, the patient’s neurological status reflected the patient was nonverbal and did not follow commands. Additional review of Patient #3’s clinical record on 06/18/2024 at approximately 11:30 AM showed Employee #6, RN, Quality Assurance Manager prepared a ‘Nursing Assessment Adult Start of Care’ dated 04/04/2024. The clinical record showed a Start of Care Date of 04/03/2024, and a current Recertification Period from 06/12/2024 through 08/10/2024. A review of Patient #3’s Plan of Care showed the following incomplete items: Plan of Care items #11, #12 and #13, titled ‘Diagnoses’ included Cerebral Palsy, Dependence on wheelchair, Cytomegaloviral disease, Other disorders of Lung, Gastrostomy Status, Urinary Incontinence, Epilepsy, Scoliosis, Bilateral Sensorineural Hearing Loss, and Wheezing. i. The diagnoses on the Plan of Care did not include all known following diagnoses: Chronic Pulmonary Aspiration, Cavitary Lung Disease, Morbid Obesity, Contractures of Upper Extremities, and Exophthalmos. ii. Plan of Care item #14, titled DME [Durable Medical Equipment] showed “NONE” and did not show reference to another section on the Plan of Care that may include the following essential items or list required supplies and equipment which are non-routine and medically necessary for the patient’s care. iii. Plan of Care item # 15, titled ‘Safety Measures’ showed “Fall precaution’ and did not include safety measures to protect against injury, including risk for infection, seizure precautions, airway precautions, aspiration precautions, pressure injury precautions and contractures. iv. Plan of Care item # 16, titled ‘Nutritional Requirements’ showed “G [Gastrostomy]-tube” and did not include description of the prescribed gastrostomy tube feeding. v. Plan of Care item # 19, titled ‘Mental/ Cognitive/ Psychosocial Status’ did not include Patient #3 was nonverbal and did not follow commands. vi. Further review of the Plan of Care did not include patient and caregiver education and training to facilitate timely discharge. Physician orders on the Plan of Care directed Private Duty Nursing, 24 hours per day, seven (7) days per week for 12 months for G-tube and medication management. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings following the review of the Plan of Care on 06/24/2024 at approximately 11:20 PM. Cross Reference G0588; and G0606.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to develop an individualized plan of care to ensure review and revision by the physician or allowed practitioner no less frequently than once every 60 days, beginning with the start of care date, for one (1) of one patient receiving skilled services, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees # 1, the agency’s Administrator; #2, Registered Nurse (RN) who is the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s the patient’s mother who is the caregiver in the presence of Employees # 1, 2, and 13. In response to the surveyor’s query about the services that agency staff provide to Patient #2, she stated that they provide physical and occupational services. The caregiver stated that the physical therapy sessions did help improve the patient’s ability to move around the home safely and added that she observed the patient is more active than she was before. She further explained that Patient#2 was unable to run but observed that she was able to move quicker than she did before. The surveyor conducted a review of Patient # 2’s clinical record on 06/14/2024 at approximately 11:00 AM that showed a current Plan of Care with a Start of Care date of 01/11/2024, and an initial Certification Period from 01/11/2024 through 12/31/2024. Plan of Care item #11 titled ‘Diagnosis’ showed Developmental Disorder of Speech and Language. Plan of Care item #21 titled ‘Orders for Discipline and Treatments (Specify Amount/ Frequency /Duration) showed the patient will benefit from occupational and physical therapy services for therapeutic strengthening exercise, mobility training exercise, transfer training exercise, range of motion exercise, balance training exercise, positioning exercises, gait training exercise, and safety precautions for one hour each day, two days per week for eight weeks. Additionally, the orders directed occupational therapy services for upper body strength one hour each day, two days per week for eight weeks. The clinical record did not include a plan of care for 60 days, beginning with the start of care date, to ensure review and revision by the physician or allowed practitioner at least once every 60 days. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings on 06/17/2024 at approximately 11:20 AM. Cross Reference G0574 and G0606

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on interviews with agency staff and caregiver, review of clinical records and the agency's policy, the Home Health Agency failed to integrate services to assure the identification of patient needs, factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines for one (1) of one (1) patient, (Patient #2). Findings included… The surveyor conducted a home visit with Patient #2 on 06/13/2024 at approximately 2:50 PM, in the presence of Employees #1, the agency’s Administrator; #2, Registered Nurse (RN), the agency’s Clinical Manager, and Employee #13, a Physical Therapist. The surveyor conducted a face-to-face interview with the patient’s mother who is the caregiver in the presence of Patient #2, Employees # 1, 2, and 13. In response to the surveyor’s question about her satisfaction with the services the agency provided to Patient #2, the patient’s mother stated that she did not like the manner displayed by Employee #14, OT (Occupational Therapist). Patient #1’s mother stated that Employee #14 did not return to the home to provide additional services and did not contact her after the first visit. During the home visit, Patient #2’s mother questioned Employee #13 of his awareness that that Employee #14 did not return after the first visit, to which Employee #13 replied, "No." The surveyor conducted a review of Patient #2’s clinical record on 06/14/2024 at approximately 11:00 AM that showed Employee #13, Physical Therapist prepared a ‘Service Type Agreement’/ ‘Consent For Services’ form dated 01/16/2024 that included the plan for Occupational Therapy weekly, two (2) hours per day, five (5) days per week for 12 months; and Physical Therapy weekly, one (1) hour per day, two (2) days per week for eight (8) months. Additional review of the clinical record showed Employee #14, prepared an ‘OT Start of Care Evaluation’ form dated 01/16/2024. Further review of the clinical record lacked documented evidence that reflect phone calls or any form of communication coordination of services between the different clinicians providing services in the home, including the lack of Employee #14 returning to the home to provide continued services or documented plans to discharge from OT service, including reason. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator, and #5, the agency’s Director of Compliance. They both acknowledged and confirmed the findings on 06/17/2024 at approximately 11:20 AM. Cross Reference G0574 and G0588.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of clinical records, and interview with agency staff, agency staff failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice in two (2) of 2 clinical records for dialysis dependent patients, (Patients# 6 and 7). Findings included... The surveyor conducted a review of Patient#6’s clinical record on 06/14/2024 at approximately 3:20 PM that showed Employee # 2, RN, Clinical Manager prepared a ‘Nursing Assessment Adult Start of Care’ dated 02/15/2024. Additional review of Patient # 6’s clinical record showed a Plan of Care for non-skilled services with a Start of Care date of 02/15/2024, and an annual Initial Certification Period from 02/15/2024 through 01/31/2025. The patient's diagnoses on the Plan of Care included End Stage Renal Disease, Hypertension, Gastro-esophageal Reflux Disease, and Abnormalities of Gait and Mobility. The Plan of Care item #21 titled ‘Orders for Discipline and Treatments’ reflected “…client goes to dialysis three times/week (Monday, Wednesday and Friday) …” Additional review of the clinical record showed the Emergency Response Team documented on a transport form dated 05/25/2024 “…patient has Lt. [Left] AV [Arteriovenous Fistula] in place to the left arm…” Further review of the clinical record shows Employee # 2 recorded the following blood pressure measurements obtained on the following dates i. 03/30/2024 blood pressure measurement showed 132/81 ii. 04/13/2024 blood pressure measurement showed 104/62; and iii. 05/18/2024 blood pressure measurement showed 104/60 mmHg [millimeters of mercury]. The clinical record lacked documented evidence that the agency’s clinician acknowledged the presence of Patient# 6’s dialysis access, enquired about it from the patient or caregiver, observed precautions to protect the extremity, and documented the specific location extremity that the blood pressure measurements were obtained. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, the Director of Compliance. They both acknowledged and confirmed the findings on 06/17/2024 at approximately 1:30 PM. b. The surveyor conducted a review of Patient #7 clinical record on 06/17/2024 at approximately 1:20 M that showed Employee # 2, RN, Clinical Manager prepared a ‘Nursing Assessment Adult Start of Care’ dated 02/07/2024. Additional review of Patient #7’s clinical record showed a Plan of Care for non-skilled services with a Start of Care date of 02/02/2024, and an annual Initial Certification Period from 02/02/2024 through 01/31/2025. The patient's diagnoses on the Plan of Care included “Other symptoms and signs involving cognitive functions and awareness”, Diabetes Mellitus, Hypertension, Unspecified Sequel of Cerebral Infarction, and Stage 5 Chronic Kidney Disease. The Plan of Care item #21 titled ‘Orders for Discipline and Treatments’ reflected “…client goes to dialysis three times/week (Monday, Wednesday and Friday) …” Further review of the clinical record shows Employee # 2 prepared recorded the following blood pressure measurements obtained on the following dates i. 02/09/2024 blood pressure measurement showed 138/76; ii. 03/20/2024 blood pressure measurement showed 132/74; iii. 04/30/2024 blood pressure measurement showed 132/79; iv. 05/30/2024 blood pressure measurement showed 120/62; and v. 06/06/2024 blood pressure measurement showed 132/78 mmHg. The clinical record lacked documented evidence that the agency’s clinician acknowledged the presence of Patient# 7’s dialysis access, enquired about it from the patient or caregiver, observed precautions to protect the extremity, and documented the specific location extremity that the blood pressure measurements were obtained. The surveyor conducted a face-to-face interview with Employees #1, the agency’s Administrator and #5, the Director of Compliance. They both acknowledged and confirmed the findings on 06/17/2024 at approximately 2:10 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 interviews with agency staff, review of clinical records and the agency's policy, the agency's clinician failed to document complete a discharge summaries in one (1) of one closed clinical record for a patient discharged from the agency, (Patient #8). Findings included... A review of the Home Health Agency’s undated policy titled “Clinical Record Contents and Maintenance” showed that a discharge summary will contain the client’s status on admission, discharge, the services provided, date of discharge, extent to which goals were achieved, a plan for follow-up and/ or referral to community resources. The surveyor conducted a review of Patient #8's clinical record on 06/25/2024 at approximately 10:30 AM that showed Employee # 13, PT (Physical Therapist), prepared a ‘Physical Therapy Start of Care’ assessment dated 10/09/2023. Additional review of Patient #8's clinical record showed a Plan of Care with a Start of Care date of 09/18/2023, and an Initial Certification Period for skilled services from 09/29/2023 to 09/30/2024. The diagnoses on the current Plan of Care included Hypertension, Fractures, and OA [Osteoarthritis of hip]. Additional review of the Plan of Care showed physician orders directed physical therapy services for residual weakness and gait disturbances following Total Hip Replacement. Further review of the clinical record showed Patient #8 received physical therapy services, and the clinical record showed a document titled “Discharge Order” dated 03/08/2024. The “Discharge Order” [Discharge Summary] showed the reason for admission to Home Health was M17.0, code10 an ICD [International Classification of Diseases] diagnosis Code with no corresponding description. The “Discharge Order” report that did not include: i. the reason for admission to Home Health; ii. the type of services provided and frequency of services; iii. admission and discharge dates iv. the patient’s condition at discharge, and v. patient and family post discharge instructions. The surveyor conducted a face-to-face interview with Employee#5, the agency’s Director of Compliance, regarding the absence of documentation in the patient’s clinical record relative to ‘Discharge Summary’. In response to the surveyor’s question, Employee#5 stated that the document titled “Discharge Order” is the agency’s ‘Discharge Summary’. She acknowledged and confirmed the findings on 06/24/2024 at approximately 2:20 PM.

An unannounced annual Emergency Preparedness survey was conducted on August 8 - 16, 2021 for this Home Health Agency. On the first day of the survey, the Home Health Agency's total active census was 204 patients. Based on the Home Health Agency's staff interviews and review of the Emergency Plan and Communication Plan, the surveyors found the Home Health Agency out of compliance with the requirements for the Emergency Preparedness Program. Standard level deficiencies were cited at §484.102 Condition of Participation for Emergency Preparedness.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on staff interviews and review of the Emergency Plans and Procedures, the Home Health Agency failed to maintain a communication plan that was reviewed and updated at least annually. Findings included: The surveyor conducted an interview with Employees #2, the Director of Compliance, and Employee 3, the Clinical Director, on 08/12/21 at approximately 3:30 PM . The Home Health Agency failed to provide documented evidence that the emergency preparedness communication plan was reviewed and updated annually. During a face-to-face interview with Employees #2 and #3, on 08/12/21 at approximately 4:30 PM, they both acknowledged the findings.

An unannounced Federal Medicare/Medicaid Home Health Agency Recertification Survey was conducted on August 10 - 16, 2021. The Agency reported that the number of unduplicated admissions for skilled services during the most recent 12-month period was sixteen (16) patients. The sample size consisted of thirteen (13) personnel records, eight (8) clinical records, and two (2) patient/staff interviews. On the first day of the survey, the agency reported the total active census was 204 patients. During this survey, complaint DC00010181 was also reviewed. The complaint was unsubstantiated. Standard level deficiencies were cited based on interviews with agency staff, patients, review of clinical records, and the Agency's policies.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on an interview with the agency staff, a review of the Agency's CMS Submission Report, and OASIS Validation Report, the Agency's staff failed to electronically transmit each completed OASIS assessment in accordance with the CMS timely guidelines within 30 days for nine (9) of fourteen (14) submitted OASIS assessments records, for the period of 02/24/21 through 06/19/21. Findings included: The Home Health Agency was unable to provide its policy-relevant to the timely transmission of OASIS Data. The surveyor reviewed the OASIS assessment record submissions and validation reports on 08/10/21 at approximately 1:30 PM, which showed the following: Patient 1 OASIS assessment record - Effective Date 04/10/21 transmitted 06/17/21 > 30 days. Patient 2 OASIS assessment record - Effective Date 04/27/21 transmitted 06/17/21 > 30 days. Patient 3 OASIS assessment record - Effective Date 04/25/21 transmitted 06/22/21 > 30 days. Patient 4 OASIS assessment record - Effective Date 04/30/21 transmitted 06/25/21 > 30 days. Patient 5 OASIS assessment record - Effective Date 05/03/21 transmitted 06/30/21 > 30 days. Patient 6 OASIS assessment record - Effective Date 04/12/21 transmitted 06/24/21 > 30 days. Patient 7 OASIS assessment record - Effective Date 02/24/21 transmitted 06/24/21 > 30 days. Patient 7 OASIS assessment record - Effective Date 04/24/21 transmitted 06/24/21 > 30 days. Patient 8 OASIS assessment record - Effective Date 04/20/21 transmitted 06/24/21 > 30 days. The Home Health Agency failed to transmit OASIS Validation data within 30 days of a completed OASIS assessment record. The surveyor conducted a face-to-face interview with Employees #2, the Director of Compliance, and 3, the Clinical Director, on 08/10/21, at approximately 3:00 PM. When queried about OASIS validation reports, Employee #2 reported the last transmittal of any OASIS data was within June 2021. Employees #2, and 3, acknowledged the findings during a face-face interview on 08/10/21, at approximately 3:30 PM.

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 clinical record review, policy review, and staff interviews, the Agency failed to ensure the clinician developed an individualized Plan of Care and included all required elements to include psychosocial and cognitive status for two (2) of the six (6) clinical records reviewed (Patients #1 and 3). Findings included: The Home Health Agency's undated policy titled "CLN.001: Patient Plan of Care" showed that the Home Health Agency would develop and implement an individualized plan of care. 1. The surveyor reviewed Patient #1's clinical record on 08/11/21 at approximately 10:30 AM. The record contained a Plan of Care with a Start of Care date of 01/17/16 and a Certification Period from 05/01/21 to 04/30/22. Patient #1's diagnoses on the Plan of Care included Paranoid Schizophrenia, Neuropathy, and Depressive Disorder. A review of Patient #1's Plan of Care did not include the psychosocial and cognitive status. 2. The surveyor reviewed Patient #3's clinical record on 08/11/21, at approximately 1:15 PM. The record contained a Plan of Care with a Start of Care date of 01/17/17 and a Certification Period from 10/01/20 to 09/31/21. Patient #3's diagnoses on the Plan of Care included Generalized Seizures, Hypertension, Diabetes Mellitus, Arthritis, Cerebral Infarction, and Congestive Heart Failure. A review of Patient #3's Plan of Care did not include the psychosocial and cognitive status. The Plan of Care lacked documented evidence of completion to include all required elements to include the psychosocial and cognitive status identified by the Home Health Agency. The surveyor conducted a face-to-face interview with Employees #2 (Director of Compliance) and #3 (Clinical Director) on 08/12/21 at approximately 11:00 AM. Both employees acknowledged the findings.