Every finding on record at Atrio Home Health Lakeshore

A Medicare recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs from 10/17/22 through 10/20/22 at: Atrio Home Health Lakeshore 9 E. 8th St. Holland, MI 49423 At the survey's conclusion, the agency was found to be in substantial compliance with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

A Medicare recertification survey which included a COVID-19 Vaccination protocol review, was conducted by the Michigan Department of Licensing and Regulatory Affairs from 10/17/22 through 10/20/22 at: Atrio Home Health Lakeshore 9 E. 8th St. Holland, MI 49423 At the time of the survey, the agency did not have any branch offices or subunits. The services the agency provided were: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Speech Therapy (ST), Medical Social Work (MSW), Registered Dietician (RD), and Home Health Aide (HHa). Clinical records reviewed included: 7 active records with home visits; 5 active records without home visits; and 5 discharge records for a total of 17 records. The following Condition level deficiency was identified at: 42 CFR § 484.60: Care planning, coordination of services, and quality of care 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 3 (MR's #13, 14, 15) of 3 patients observed during home visits, were included in the overall planning of care including the timeliness of services received; and failed to inform the patient/caregiver in advance of the days in which services would be provided resulting lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: MR #13: The patient's start of care (SOC) was 8/6/22 with diagnoses that included Syndrome of Secretion of Antidiuretic Hormone. On 10/17/22 at 3:57 p.m., the clinical record revealed that Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services had been ordered. On 10/17/22 at 2:00 p.m., a joint home visit was conducted with the Occupational Therapist (OT #1). During the visit, the patient's admission packet was reviewed. The patient's visit calendar had not been completed to reflect proposed visits to be made by the RN, OT or PT. Upon completion of the visit, OT #1 stated (to the patient) "I'll see you next week, either Monday or Tuesday afternoon." The patient had not been included in the planning of care including the frequency of proposed visits. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 9:16 a.m. MR #14: The patient's SOC was 10/5/22 with diagnoses that includedCovid-19, Hypertensive Heart Disease and Weakness. During the record review on 10/18/22 at 4:20 p.m., it was noted that SN, PT and OT had been ordered to provide services. On 10/18/22 at 9:00 a.m., a joint home visit was conducted with the Registered Nurse (RN #1). During the visit, the patient's admission packet was reviewed. The patient's visit calendar had not been completed to reflect the proposed visits to be made by the RN, OT or PT. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 9:05 p.m. MR #15: The patient's SOC was 10/1/22 with diagnoses that included Rectal Cancer with colostomy placement. The record review conducted on 10/18/22 at 1:30 p.m. revealed the patient was to receive SN, OT, PT and Home Health Aide (HHa) services. On 10/18/22 at 11:30 a.m., a joint home visit was conducted with the Home Health Aide (HHa #1). During the visit, the patient's admission packet was reviewed. The patient's visit calendar had not been completed to reflect the proposed visits to be made by the RN, OT, PT or HHa. These findings were reviewed with the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 8:19 a.m.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on interview, the Agency failed to provide documented evidence of the details of the investigation and the resolution of the complaints, as per this requirement, resulting in the potential for unaddressed patient/family concerns, inability to exercise one's rights and unmet care needs. Findings include: On 10/19/22 at 3:00 p.m., the Agency's Complaint Log was reviewed. During the review, 6 of the 10 complaints reviewed for calendar year 2021 were found to be void of a documented resolution and follow-up. Examples included: "Corrective Action: Informed staff of complaint daughter made." "Spoke with OT (Occupational Therapist) about complaint." "Informed her (complainant) I would speak with staff involved." Further review revealed that in one of the lodged complaints, the alleged was allowed to conduct the investigation. The Agency failed to document the investigation which included documentation of a resolution and follow-up. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager at the time of discovery. The Administrator responded, "This is my fault. I guess we've been doing it wrong all along."

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included an accurate reflection of the patient’s current health, psychosocial, and functional status in 7 of 17 records reviewed (MR# 8, 10, 11, 12, 14, 15, 16) resulting in incomplete clinical information to aid in determining the needs of these patient. Findings include: MR #14: The patient's start of care (SOC) was 10/5/22 with diagnoses that included Covid-19, Hypertensive Heart disease, Atherosclerotic Heart disease and Weakness. During the record review on 10/18/22 at 4:20 p.m., the Initial comprehensive Assessment (ICA) dated 10/5/22 revealed a list of patient diagnoses. There were no dates of onset/exacerbation that indicated what the treating diagnoses were and no narrative that detailed the events that lead to the need for home care referral. The assessment listed a baseline weight of 179 pounds (lbs.), however, did not indicate whether this was a reported or an actual weight. Additionally, section M2001/Medication Review documented No issues found during review. Further review revealed that severe drug interactions had been identified by Agency personnel. The Initial Comprehensive Assessment did not paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 9:05 a.m. MR #15: The patient's SOC was 10/1/22 with diagnoses that included Rectal Cancer with Colostomy placement. During the record review on 10/18/22 at 1:30 p.m., the ICA listed patient diagnoses that had no dates of onset/exacerbation and no narrative that detailed the events that lead to the need for home care referral. During the review, it was revealed that the patient had several surgical wounds, a colostomy pouch and a Jackson-Pratt posterior drain tube. There was no diagram that described the location of the aforementioned surgical sites. Further reviewed revealed that no baseline pain level had been identified. Lastly, the section that addressed the Medication review documented, "No issues found during review", however, the POC identified severe drug to drug interactions. The Initial Comprehensive Assessment did not paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 8:19 a.m. MR #16: The patient's SOC was 8/16/22 with diagnoses that included Pneumonitis, CHF and Dysphagia (Difficulty Swallowing). During the record review on 10/19/22 at 10:48 a.m., the ICA revealed a list of patient's diagnoses. There were no dates of onset/exacerbation to indicate which diagnoses were to be treated and no narrative that detailed the events that lead to the need for home care. The assessment documented a baseline weight of 188 lbs.; however, it was not indicated if this was a reported or an actual weight. Additionally, section M2001/Medication review documented, "No issues found during review." The POC identified several severe drug to drug interactions. The Initial Comprehensive Assessment did not paint a clear clinical picture of the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 10:48 a.m. **Agency Policy: “Atrio Home Health Lakeshore Initial Assessment” revised date 2/25/2022 was reviewed on 10/19/22 and stated under “Procedure”: “1. During the initial patient assessment, all baseline data and other relevant information will be documented in the patient’s clinical record, including at least the following information: . . . O. Review of past medical and surgical care including dates of onset/exacerbation, relevant to current reason patient is being seen.”. MR# 8: This 81-year-old patient was admitted to agency on 10/11/22 for diagnoses which included heart attack; atrial fibrillation (abnormal rhythm of the heartbeat); and chronic kidney disease. The clinical record was reviewed on 10/17/22. The start of care (SOC) assessment dated 10/11/22 listed the patient's diagnoses in section M1021/1023 and did not include dates of onset or exacerbation. The plan of care (POC) dated 10/11/22 was noted to include a diagnosis date for the “Primary Diagnosis” of heart attack as 10/10/22 and included a list of over 50 “Other Pertinent Diagnosis” which were all dated 10/11/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care was documented within the Comprehensive Assessment completed on 10/11/22. MR# 10: This 72-year-old patient was admitted to agency on 8/19/22 with diagnoses which included type 2 diabetes mellitus with diabetic polyneuropathy (affecting nerve function); muscle wasting (loss of muscle mass); and paralysis of the right side of the body after a stroke. The clinical record was reviewed on 10/20/22. The SOC assessment was dated 8/19/22 and listed the patients diagnoses in section M1021/1023 and did not include dates of onset or exacerbation. The POC dated 8/19/22 was noted to include documentation under “Primary Diagnosis” and “Other Pertinent Diagnosis” with a list of 17 diagnoses which were all dated 8/19/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care was documented within the Comprehensive Assessment completed on 8/19/22. MR# 11: This 72-year-old patient was admitted to agency on 9/15/22 with diagnoses which included gastroenteritis (inflammation of the digestive tract); colitis (inflammation of the lining of the large intestine); congestive heart failure; and type 2 diabetes. The clinical record was reviewed on 10/19/22. The SOC assessment was dated 9/15/22 and listed the patients diagnoses in section M1021/1023 and did not include dates of onset or exacerbation. The POC dated 9/15/22 was noted to include documentation under “Primary Diagnosis” and “Other Pertinent Diagnosis” with a list of 37 diagnoses which were all dated 9/15/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care was documented within the Comprehensive Assessment completed on 9/15/22. MR# 12: This 68-year-old patient was admitted to agency on 2/25/22 with diagnoses which included type 2 diabetes mellitus and diabetic chronic kidney disease with dependence on renal dialysis. The clinical record was reviewed on 10/19/22. The SOC assessment dated 2/25/22 listed the patients diagnoses in section M1021/1023 and did not include dates of onset or exacerbation. The POC dated 2/25/22 was noted to include documentation under “Primary Diagnosis” and “Other Pertinent Diagnosis” with a list of 16 diagnoses which were all dated 2/25/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care was documented within the Comprehensive Assessment completed on 2/25/22. All the above findings were reviewed and acknowledged on 10/20/22 during interview at 1:30 p.m. by the Administrator (Admin A); the Clinical Manager (Staff B); and the Quality Assurance nurse (Staff C).

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on Record Review and Interview, the agency failed to identify potential clinically significant medication issues and report to the physician in 1 of 17 (MR#1) records reviewed. This deficient practice could result in the potential for unrecognized medication side effects and drug interactions that could affect all patients serviced by the agency. Findings included: **Agency Policy: "Adverse Drug Reactions", reviewed 2/25/2022. The policy states, "All clinical personnel will be prepared to identify and react to adverse drug reactions. All adverse drug reactions will be reported both internally and externally, so appropriate agencies as needed. All adverse reactions will be promptly reported to the patient's physician in order to minimize the patient's health risks and discomfort. MR#1: The Start of Care was dated 8/28/22. The patient's diagnoses for the certification period 8/28/22 to 10/26/2022 included Localization-related symptomatic epilepsy and epileptic syndromes with simple partial seizures not intractable without status epilepticus, Neurocognitive disorder with Lewy bodies, Congestive Heart Failure (CHF), and Type 2 Diabetes (DM2). During a review of the patient's medication via drugs.com, a major interaction was identified with the concurrent use of aluminum hydroxide and cholecalciferol which can result in dementia and seizures. This patient has a primary diagnosis of epilepsy with simple partial seizures, and a neurocognitive disorder with Lewy bodies, a form of dementia. The agency documented on the Comprehensive assessment under the category of (M-2001) drug review, "no issues found." These findings were reviewed and acknowledged by the Administrator (Admin A), Clinical Manager (Staff B), and Quality Assurance (Staff C) during an interview on 10/20/22 at 12:30 p.m.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Speech Therapist completed a detailed Discharge Summary that detailed the course of care provided, the patient's health status at the time of discharge and was forwarded to the Physician within 5 days of the date of discharge for 1 (MR #16) record, from a total of 17 sampled records reviewed, resulting in the Physician not having information on the potential continuing needs of the patient at the time of discharge, and unmet care needs. Findings include: Policy: Discharge and/or End of Certification Summary, 4/6/22 stated, "Each clinician who provides care will complete a patient summary upon discharge of the patient from their particular discipline. The discharge summary and other relevant clinical record documents will be completed within 3 days of discharge from the agency or within 3 days of the agency having knowledge of the discharge. The discharge summary will be faxed to the provider." MR #16: The patient's start of care (SOC) was 8/16/22 with diagnoses that included Pneumonitis, Dysphagia (difficulty swallowing) and Congestive Heart Failure (CHF). During the clinical record review on 10/19/22 at 10:48 a.m., it was noted that the referral for home care ordered Skilled Nursing, Physical Therapy, Occupational Therapy and Speech Therapy services to be provided. During the review, it was further noted that the patient was discharged from Speech Therapy services on 10/7/22. No Speech Therapy Discharge Summary had been completed at the time of this review. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22 at 10:56 a.m.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the Agency failed to ensure the plan of care addressed the individualized needs of the patient and included all pertinent interventions with reportable parameters and objectively measurable goals for 10 of 17 (MR#'s 1, 2, 3, 4, 5, 6, 9, 15, 16) records reviewed, resulting in patients not receiving care specific to their individualized needs and the potential for unmet patient care needs (G574); failed to ensure the physician ordered treatment for wound care was administered only as ordered for 1 of 3 (MR# 9) sample records for which the patient was receiving wound care resulting in the potential for unidentified complications and unrecognized deterioration of the patient's wounds (G580); failed to ensure the physician was promptly notified of the severe drug interactions that were identified in 4 (MR#'s 14, 15, 16, 17) records reviewed that were found to have severe drug interactions, and 2 (MR#s 11, 17) records with significant fluctuations in weight from a total of 17 records reviewed, resulting in the potential for hazardous medication consumption, unidentified/untreated health concerns and poor patient outcomes (G590); failed to ensure the integration of orders from all physicians involved in the plan of care for 1 of 4 (MR# 8) sample records reviewed for which a home visit was made with a patient residing in an assisted living facility potentially resulting in undetected overmedication and poor patient outcomes (G604); failed to provide 2 of 3 (MR#'s 14, 15) patients observed during home visits with a Medication Profile that included the names, dosages, frequencies and side effects 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 (G616); and, failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet for Skilled Nurse openings, resulting in the potential for unaddressed patient concerns (G622). The cumulative effect of these systemic problems resulted in the Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR 484.60 Care Planning, Coordination, Quality of Care.

Plan of care 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 addressed the individualized needs of the patient and included all pertinent interventions with reportable parameters and objectively measurable goals for 10 (MR#'s 1, 2, 3, 4, 5, 6, 9, 15, 16) records, from a total of 17 sampled records reviewed, resulting in patients not receiving care specific to their individualized needs and the potential for unmet patient care needs. Findings include: MR #15: The patient's start of care (SOC) was 10/1/22 with diagnoses that included Rectal Cancer with Colostomy placement and Iron Deficiency Anemia. During the clinical record review on 10/18/22 at 1:30 p.m., it was also noted that the patient had a surgical (Jackson-Pratt) drain to her buttocks. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT), Home Health aide (HHa) and Occupational Therapy (OT) services to be provided. The listed diagnoses all reflected the date of admission. The POC was vague with instructions such as: Assess for signs of infection, teach pain management, teach complications of ostomy. The POC was void of reportable pain parameters and failed to include interventions and frequency in which to change the Colostomy wafer/dressing along with what to report. There was no guidance on what to report regarding the drainage bulb and no guidance regarding showering, if allowed. Additionally, there were no measurable goals to address the above interventions. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 8:19 a.m. MR #16: The patient's SOC was 8/16/22 with diagnoses that included Pneumonitis, Congestive Heart Failure (CHF), Diabetes and Dysphagia (Difficulty Swallowing). The referral for home care dated 8/15/22 ordered SN, PT, OT and Speech Therapy services. The record review was conducted on 10/19/22 at 10:48 a.m. at which time, the POC was noted to be void of reportable pain parameters, blood glucose parameters, and reportable parameters regarding the patient's weight and edema. The listed diagnoses all had the same date as the date of admission. Further, the SN interventions were vague such as, instruct patient/caregiver on safety measures, assess symptoms of CHF, HTN..., assess diabetic complications. Additionally, there were no measurable goals to address the above interventions. These findings were reviewed with an acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22 at 10:56 a.m. MR# 9: This 88-year-old patient was re-certified for services with the agency on 8/17/22 for diagnoses which included Clostridium difficile` recurrent (bacterial infection of large intestine); abnormal weight loss and weakness. The clinical record was reviewed on 10/19/22. The start of care (SOC) assessment was reviewed, and it was noted that the patient was alert and oriented to his needs and abilities, was able to make his own decisions, and lived alone with no caregivers present. The plan of care (POC) dated 8/17/22 included the following goals for the Medical Social Worker: “Patient/caregiver will identify and access care system resources to assist with ADL care; Target date: 10/15/22”. The examples of the goals listed for skilled nursing (SN) included: “Patient/caregiver will be able to demonstrate appropriate medication administration technique of stated prescribed medication; Target Date: 10/15/2022”. These goals are not individualized to the patient as the patient did not have a caregiver. Additional examples of goals listed by SN include: Optimal activity level achieved and maintained within baseline respiratory and energy parameters; Target Date: 10/15/2022; Patient will verbalize ways to maintain adequate nutrition and hydration; Target Date: 10/15/2022. It was unclear how these goals would be objectively measured by the SN to determine progress toward the goals. These findings were reviewed and acknowledged during interview on 10/20/22 at 1:10 p.m. with the Administrator (Admin A); Clinical Manager (Staff B); and Quality Assurance nurse (Staff C). MR#1: The Start of Care (SOC) was dated 8/28/22. Diagnoses for the certification period 8/28/22 to 10/26/2022 included Localization-related symptomatic epilepsy and epileptic syndromes with simple partial seizures not intractable without status epilepticus; Neurocognitive disorder with Lewy bodies, Congestive Heart Failure (CHF), and Type 2 Diabetes (DM2). This patient was receiving Skilled Nursing (SN), Home Health aide (HHa), Physical Therapy (PT), Occupational Therapy (OT), Speech Therapy (ST) and Medical Social Work (MSW) services. Upon review of the POC it was noted the goals were not objectively measurable to determine the patient's progress towards goals. Examples include: Skilled Nurse Goals: "Patient/Caregiver can describe management of a seizure episode; Patient recognizes energy limitations and understands/uses energy conservation techniques." Aide Goals: "Patient's personal care needs will be met" Physical Therapy Goals: "Patient will demonstrate improved balance and a reduced falls risk as evidenced by stated improved functional mobility." Speech Therapy Goals: "Caregiver will verbalize/demonstrate good level of understanding as it related to patient's impaired cognition and ability to safely perform ADL/IADL activities." Medical Social Work Goals: "Patient can participate in decision making/care delivery." These goals are not objectively measurable to determine the patient's progress towards goals. MR#2: The SOC was dated 9/8/2022. The Plan of Care for the certification period 9/8/22 to11/6/2022 identified diagnoses of Congestive Heart Failure, Syncope and collapse, and acute Kidney Failure. The patient was receiving skilled nursing (SN) and physical therapy (PT) services. Upon review of the Plan of Care (POC), it was noted the goals on the POC were not objectively measurable. Findings included: "Patient's symptoms will be consistent with state of CHF disease process and problems managed as well as disease process will allow; Patient/caregiver monitors patient's weight and weight changes and reports any weight gain to clinician; Patient's symptoms will be consistent with stage of CHF disease process and problems managed as well as disease process will allow. These goals are not objectively measurable to determine the patient's progress toward obtaining these goals. MR#3: The Start of Care (SOC) was dated 10/7/2022. The Plan of Care (POC) for the certification period 10/7/2022 to 12/5/2022 identified diagnoses of Hypertensive Heart Disease with Heart Failure, Chronic Kidney Disease, Atrial Fibrillation, Abdominal Aortic Aneurism. Findings included: "Patient/caregiver will demonstrate necessary behaviors to maintain good safety awareness and minimize the risk of falls and/or injury, Complete healing of wounds without complications, Patient/caregiver monitors patient's weight and weight changes and reports any weight gain to clinician. These goals are not objectively measurable to determine the patients progress towards goals. MR#4: The Start of Care (SOC) was dated 10/10/2022. The Plan of Care (POC) for the certification period 10/10/2022 to 12/8/2022 identified diagnoses of Aftercare following joint replacement of right hip, Hypertension (HTN), Polyosteoarthritis, Dizziness and Giddiness. A review of the goals on the POC revealed the goals were not objectively measurable to determine the patient's progress towards obtaining the goal. Examples include: "Patient can demonstrate techniques to promote healing of incision, Patient will be pain free or verbalize an acceptable pain level with current pain management regimen, Patient maintains vital signs within parameters." These goals are not objectively measurable to determine the patient's progress towards goals. MR#5: The Start of Care (SOC) was dated 9/8/2022. The Plan of Care (POC) for the certification period 9/8/22 to 11/6/22 identified diagnoses of Pulmonary embolism without acute cor pulmonale, Chronic Kidney Disease (CKD), Dementia with behavioral disturbance, and Depressive Disorder. Upon review, it was noted the goals on the POC were not objectively measurable. Examples include: "Patient/caregiver can demonstrate appropriate use of assistive adaptive device, Patient will be able to participate in sustained activity to increase functional endurance, and Patient will demonstrate knowledge of measures to maintain adequate nutrition and hydration." These goals are not objectively measurable to determine the patient's progress to obtaining the goals. MR#6: The Start of Care (SOC) was dated 8/19/20222. The Plan of Care (POC) for the certification period 8/19/2022 to 10/17/2022 identified diagnoses of Diabetes type 2 (DM2), Hypertension (HTN), Abnormal gait and mobility, glaucoma, and amnesia. It was determined upon review of the goals on the POC that the goals were not objectively measurable to determine the patient's progress towards goals. Examples included: "Patient/Caregiver able to identify signs /symptoms to report to medical doctor-actions to take related to hypertension, Patient/Caregiver understands adequate nutrition/hydration, Patient/caregiver understand signs/symptoms of complications related to diabetes and when to report." These goals are not objectively measurable to determine the patient's progress towards goals. These findings were reviewed and acknowledged by the Administrator (Admin A), Clinical Manager (Staff B), and Quality Assurance (Staff C) on 10/20/22 at 12:30 p.m.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician ordered treatment for wound care was administered only as ordered for 1 of 3 (MR# 9) sample records for which the patient was receiving wound care from a total of 17 records reviewed resulting in the potential for unidentified complications and unrecognized deterioration of the patient's wounds. Findings include: MR# 9: This 88-year-old patient was re-certified for services with the agency on 8/17/22 for diagnoses which included recurrent Clostridium difficile (bacterial infection of large intestine); abnormal weight loss and weakness. The clinical record was reviewed on 10/19/22. The skilled nurse (SN) documented in a communication note dated 9/13/22 that the patient had 2 skin tears (one on left knee and one on right lower arm) related to a fall that occurred the night before and "wound care done". On 9/13/22, there was a verbal order received by the SN for wound care: "1. Perform wound care/dressing change to left knee. SNF to perform 2x/week and prn (as needed). Cleanse skin tear with soap and water, cover with foam dressing or wrap with kerlix wrap/bandage. 2: Perform wound care/dressing change to right lower UE (upper extremity). SNF to perform 2x/week and prn (as needed). Cleanse skin tear with soap and water, cover with foam dressing or wrap with kerlix wrap/bandage." (sic). The second SN visit during that week was on 9/16/22 with the following documentation: "dressings appear clean and intact, dressing change deferred to next visit.". Dressing changes and measurements of wounds were documented for the following 3 SN visits on 9/19/22, 9/22/22, and 9/26/22. On 10/4/22 (8 days since last SN visit) the communication note entered by the SN stated, "Pt (patient) is cleaning skin tears and managing dressing changes when needed.". The dressing orders received on 9/13/22 were still in the active status at the time of clinical record review on 10/19/22. There was no evidence that the physician was updated regarding the wound status, was aware that the SN was no longer changing the dressings, or that the patient was cleaning his wounds and changing his own dressings. During interview with the Administrator (Admin A) on 10/20/22 at 1:15 p.m., inquiry was made to the meaning of "SNF" in the orders. Admin A stated that SNF usually referred to Skilled Nursing Facility and this patient lived in his own residence. She believed that SNF was entered in error and should have been just "SN" to signify that a skilled nurse would be changing the bandage 2 times per week. These findings were reviewed and acknowledged during interview on 10/20/22 at 1:15 p.m. with Admin A; Clinical Manager (Staff B); and Quality Assurance nurse (Staff C).

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Physician was promptly notified of the severe drug interactions that were identified in 4 (MR#'s 14, 15, 16, 17) records reviewed that were found to have severe drug interactions, and 2 (MR#s 11, 17) records with significant fluctuations in weight, from a total of 17 sampled records reviewed, resulting in the potential for hazardous medication consumption, unidentified/untreated health concerns and poor patient outcomes. Findings include: MR #14: The patient's start of care (SOC) was 10/5/22 with diagnoses that included Covid-19, Hypertensive Heart Disease and Weakness. During the clinical record review on 10/18/22 at 4:20 p.m., it was noted that the plan of care (POC) identified Severe drug interactions between the patient's amiodarone and Warfarin. Upon further review, there was no documented evidence that the Physician had been promptly notified of the severe drug interactions. These findings were discussed with the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 9:05 a.m. MR #15: The patient's SOC was 10/1/22 with diagnoses that included Rectal Cancer. During the clinical record review on 10/18/22 at 1:30 p.m., it was noted that the POC identified Severe drug interactions and documented, "Severe Interactions-Medication reconciliation was run, and the Client's med list was found to have severe interactions between methocarbamol/tramadol, ondansetron/tramadol, phenazopyride/prilocaine." Upon further review, there was no documented evidence that the Physician had been promptly notified regarding the identified severe drug to drug interactions. These findings were discussed with the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 8:19 a.m. MR #16: The patient's SOC was 8/16/22 with diagnoses that included Pneumonitis, Congestive Heart Failure (CHF) and Dysphagia. During the record review on 10/19/22 at 10:48 a.m., it was noted that the POC reflected Severe drug interactions and documented, "Severe Interactions-Medication reconciliation was run and the Client's med list was found to have severe interactions between: Oxycodone/Gabapentin..." There was no documented evidence that the Physician had been promptly notified of the Severe drug to drug interactions. These findings were reviewed with the Administrator, clinical manger and Quality Manager during an interview on 10/20/22 at 10:56 a.m. MR #17: The patient's SOC was 12/16/21 with diagnoses that included Hypertensive Heart Disease with Heart Failure, CHF and Chronic Respiratory Failure. The patient was discharged on 2/7/22. During the record review on 10/20/22 at 12:15 p.m., it was noted that the POC identified Severe drug interactions and documented, "Medication reconciliation was run, and the Client's med list was found to have severe interactions between Nortriptyline and Duloxetine. These medications together increased risk for serotonin syndrome." Upon further review, there was no documented evidence that the Physician had been notified of the Severe drug to drug interactions. These findings were reviewed with the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22. During the above interviews, the Clinical Manager was asked to provide documented evidence of when the Physician was notified of the identified severe drug to drug interactions and stated she would look into the matter and return with the requested information. On 10/20/22 at 12:48 p.m., the Administrator presented additional copies of the above plans of care and stated, "All four of these records do not have timely notification as they (severe drug to drug interaction documentation) were sent out when the POC was completed. What we learned from this is that there needs to be a phone call on the day of, or a fax that is sent out (to the Physician) on the day of." Additional review of MR #17 revealed that the patient had a baseline weight of 216 pounds (lbs.) at the SOC/12/16/21. On 12/16/21 the patient had a documented weight of 207.6 lbs. this was a weight loss of 8 lbs. 12 ounces (oz.). On 12/20/22, the patient's recorded weight was 204.1 lb. This reflected an additional 3.5 lb. weight loss. On 1/5/22, the patient's weight was recorded as 201 lbs., a 4 lb. weight loss. The POC documented, "Weight increases will be less than 3 lbs. in 1 day or 5 lbs. in 7 days." There was no documented plan that addressed rapid weight loss. Throughout the clinical record review, there was no documented evidence that the Physician had been notified of the patient's significant fluctuations in weight. These findings were reviewed with and acknowledged by the Agency's Administration during the above interview. MR# 11: This 72-year-old patient was admitted to agency on 9/15/22 with diagnoses which included congestive heart failure. The clinical record was reviewed on 10/19/22. The plan of care (POC) dated 9/15/22 indicated that the skilled nurse (SN) would monitor daily weights and report weight gain of 2 pounds overnight and/or 5 pounds within a 7-day period to the physician. The start of care (SOC) assessment dated 9/15/22 recorded the weight as 178 pounds and 0 ounces at 12:38 p.m., lung sounds were clear, and the patient had shortness of breath only with activity. The SN entered a communication note on 9/16/22 which indicated that Holland Hospital would be “dropping off a telemonitor this afternoon”. It is not clear in any documentation that followed if that occurred on 9/16/22 as planned. The next SN visit was on 9/21/22 (6 days after SOC) and the documented weight was 190 pounds, the patient had some shortness of breath noted at rest, and the left lower lung sounds were diminished. There was no documentation indicating the SN communicated the 12-pound increase in weight or other findings to the physician on 9/21/22. A communication note entered by the SN on 9/25/22 (4 days later) regarding the visit on 9/21/22 indicated the SN had received a call from Holland Hospital telehealth group (first name only with no title documented) regarding the patient’s weight. It is not clear when this call was received by the SN. The SN also documented that the telehealth group reported the baseline weight to be 191.4 pounds however, it is not apparent in the note when that baseline weight was taken. The SN documented that a call was made to the primary care provider’s office and a message was left via voice mail to an office staff member (first name only with no title) for a return call. There is no further documentation that a follow up call was received, or the physician was made aware of the 12-pound weight increase or other changes in assessment findings. These findings were reviewed and acknowledged during interview on 10/20/22 at 1:10 p.m. by the Administrator (Admin A); Clinical Manager (Staff B); and Quality Assurance nurse (Staff C).

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the integration of medication orders from all physicians involved in the plan of care for 1 of 4 (MR# 8) sample records reviewed for which a home visit was made with a patient residing in an assisted living facility potentially resulting in undetected overmedication and poor patient outcomes. Findings include: MR# 8: This 81-year-old patient was admitted to agency on 10/11/22 for diagnoses which included Parkinson's Disease. The clinical record was reviewed on 10/18/22. During a joint home visit with the PT on 10/17/22 to the assisted living facility (ALF) where the patient resided, an updated facility medication record dated 10/17/22 was requested and received for review and comparison with the medications listed on the most current agency medication profile. During comparison on 10/18/22, it was noted that a different physician name was listed on the facility medication record and the agency medication profile. Both physicians were listed on the patients face sheet created by the agency. A discrepancy was noted with the medication Carbidopa-Levodopa 25-100mg. On the ALF medication record, this medication had an order status of “active” and was listed twice with different instructions: “Give 1 tablet orally five times a day…” with order start date of 10/14/22, and “Give 1 tablet orally four times a day...” with order start date as 10/15/22. This was a total daily dose of 9 tablets. The agency medication profile printed on 10/18/22 only had this medication listed once and was “active” with start date of 10/11/22 with the following instructions: “Take 1 tab (s) oral 5 times a day”. This discrepancy was brought to the attention of the Clinical Manager (Staff B) upon finding it. Staff B was not able to give explanation of the discrepancy and followed up with the ALF staff right away to be sure of proper dosing and review the order. Staff B stated that the ALF was administering the correct dose according to orders received at the ALF and was not able to identify why the agency medication profile was not updated. This finding was reviewed and acknowledged during interview on 10/20/22 at 1:20 p.m. by the Administrator (Admin A); Staff B; and Quality Assurance nurse (Staff C).

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the agency failed to provide 2 (MR#'s 14, 15) of 3 patients observed during home visits, with a Medication Profile that included the names, dosages, frequencies and side effects of the patient's prescribed medications, in plain language, from a total of 17 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: The Agency did not have a policy that addressed the above deficiency. MR #14: The patient's start of care (SOC) was 10/5/22 with diagnoses that included Status Post Covid-19, Hypertensive Heart Disease and Weakness. On 10/18/22 at 9:00 a.m., a joint survey home visit was conducted with the Registered Nurse (RN #1). During a review of the patient's admission packet, it was noted that there was no Medication Profile that listed the patient's prescribed medications and dosages. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 10/19/22 at 9:05 a.m. MR #15: The patient's SOC was 10/1/22 with diagnoses that included Rectal Cancer with Colostomy placement and Iron Deficiency Anemia. On 10/18/22 at 11:30 a.m., a joint survey home visit was conducted with the Home Health Aide (HHa #1). During a review of the patient's admission packet, it was noted that there was no Medication Profile that listed the patient's prescribed medications, and dosages. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 10/19/22 at 8:19 p.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 for Skilled Nurse openings, resulting in the potential for unaddressed patient concerns. Findings include: On 10/19/22, the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's Clinical Manager. These findings were reviewed with and confirmed by the Administrator and Clinical Manager during the Exit Conference.

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 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 10/19/22 at 2:15 p.m., upon review of the Agency's "Covid-19 Vaccination Policy" dated 11/15/21, it was noted that the afore-mentioned requirements had not been included. There was no contingency plan put in to place for all staff who had not been vaccinated and/or who had been granted an exemption. There was no process put into place for tracking those individuals who had not been vaccinated. There was no process for the implementation of additional precautions for all staff who had not been vaccinated fully or in part. These findings were discussed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 2:50 p.m.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Physical Therapist (PT), Occupational Therapist and Speech Therapist assisted the Physician in evaluating the patient's level of function and helped to develop the plan of care for 3 (MR#'s 15, 16, 17) records in which Therapy services were required, from a total of 17 sampled records reviewed, resulting in the potential for decline in physical functioning, poor patient outcomes and unmet care needs. Findings include: During the Entrance Conference on 10/17/22 at 10:35 a.m., with the Administrator, Clinical Manager and Quality Manager, it was reported that when Therapy services are ordered, the system (MatrixCare) sets a priority level as to when the patient will be evaluated/treated. MR #15: The patient's start of care (SOC) was 10/1/22 with diagnoses that included Rectal Cancer with colostomy placement and Iron Deficiency Anemia. During the record review on 10/18/22 at 1:30 p.m., it was noted that the referral for home care dated 9/23/22 ordered Skilled Nursing (SN), Home Health Aide (HHa), Occupational Therapy (OT) and Physical Therapy (PT) services to be provided. Upon further review, it was noted that the PT Evaluation (Eval) was conducted on 10/6/22 (5 days after the SOC). The OT Eval was not conducted until the third week of service, on 10/11/22. Additionally, there was no documented evidence that the patient declined services or requested to have the needed services delayed. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 8:19 a.m. MR #16: The patient's SOC was 8/16/22 with diagnoses that included Pneumonitis, Congestive Heart Failure (CHF) and Dysphagia (Difficulty Swallowing). During the clinical record review on 10/19/22 at 10:48 a.m., it was noted that the referral for home care dated 8/15/22, ordered SN, PT, OT and Speech Therapy (ST) to be provided. Upon further review, it was discovered that ST did not conduct the initial evaluation until 8/27/22. This was 11 days after the SOC date. Additionally, there was no documented evidence that the patient declined services or requested to have the needed services delayed. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22 at 10:56 a.m. MR #17: The patient's SOC was 12/16/21 with diagnoses that included Hypertensive Heart Disease with Heart Failure, CHF, Respiratory Failure and Abnormal Gait. During the clinical record review on 10/20/22 at 12:15 p.m., it was noted that the referral for home care dated 12/14/21, ordered SN, HHa, PT and OT services to be provided. Further review revealed that OT did not conduct the Initial Eval until the second week of service which was 8 days after the SOC. Additionally, there was no documented evidence that the patient declined services or requested to have the needed services delayed. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22. On 10/20/22, an additional interview was conducted with the Therapy Manager (TM #1). When queried about the timeframe in which the ordered Therapy services were required to conduct the initial evaluation, TM #1 initially reported, "As soon as possible", then stated, "I think our policy states within 5 days." TM #1 later addressed this writer and reported, "I reviewed our policy, and it isn't specific with regard to the time frames, but I would say they should be out as soon as possible."

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the Agency failed to ensure the clinical record was complete and included accurate documentation within Nursing visits for 1 (MR #15) record; and, failed to ensure the clinical record included approved medical abbreviations in 1 (MR #1) record, from a total of 17 sampled records reviewed, resulting in the clinical record not accurately reflecting the status and needs of the patient, and the potential for unmet care needs. Findings include: MR #15: The patient's start of care (SOC) was 10/1/22 with diagnoses that included Rectal Cancer with placement of colostomy and Jackson-Pratt drainage system. The plan of care (POC) ordered skilled nursing at a frequency of 2x/wk. x 2 wks., 1x/wk. x 4 wks. and 2 PRN (as needed) visits for complications. On 10/18/22 at 11:30 a.m., a joint home visit was conducted with the Home Health Aide (HHa #1). During the visit, the patient was observed to have brown drainage in her Jackson-Pratt (JP) bulb. The patient reported, "The nurse knows about it and thinks it may be infected. I have to see my doctor about it." On 10/18/22 at 1:30 p.m., during the clinical record review, it was noted that the nurse documented the patient had "serosanguinous" (thin and watery fluid that is pink in color due to the presence of small amounts of red blood cells. The presence of serosanguineous drainage is a normal occurrence) colored drainage on 10/4/22, 10/6/22 and 10/13/22. There was no documentation within the nursing visit notes that accurately described the characteristics of the patient's wound drainage. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/19/22 at 8:19 a.m. to which the Clinical Manager responded, "These are good things we'll need to look at. The disciplines have to be more descriptive about the drainage. On 10/20/22, prior to conclusion of the survey, the skilled nursing visit note for 10/18/22 was reviewed. It was noted that the nurse continued to document and describe the patient's drainage as serosanguinous. These findings were again reviewed and acknowledged by the above parties during the Exit Conference. **Agency Policy: "Atrio Home Health Lakeshore Abbreviations and Symbols," reviewed 3/30/22. The purpose states, "To define acceptable standard abbreviations and symbols for use in clinical documentation." The policy states, "Atrio Home Health Lakeshore personnel will use standard approved abbreviations and symbols in documenting in the clinical record." The Guidelines states, "Additional abbreviations and symbols may be added to the standard list if approved by Atrio Health Lakeshore Director and Clinical Supervisor." Upon review, it was noted that the Skilled Nurse (Staff C) documented the Primary Diagnosis in the Plan of Care for MR#1 as follows: "Primary Diagnosis: 8/28/22. "Local-rel symptc epi w simp prt seiz "not ntrct" w/o stat epi (E)" (G40.109). A review of the agency's "Abbreviations and Symbols Policy" failed to include any of the above abbreviations except for "stat", which was defined as immediately. The use of the undefined abbreviations made it difficult to understand the patient's Primary Diagnosis. In addition, it was noted during review of the patient's Skilled Nurse visit notes under the "Review of Systems Headings", that the nurse would refer the reader to "Please refer to intervention documentation" rather than documenting the patient's actual current health status under each system. For example, for MR#2, under the "Review of Systems-Cardiovascular", RN#3 documented under "Status: Cardiovascular", "Please refer to intervention documentation" rather than documenting the actual current cardiac status for the patient during the assessment, resulting in a hunt elsewhere within the record to find what the patient's cardiac status actually was during the day of the assessment. This same type of documentation method was also found in MR#'s 1, 2, 3, 4, 5, and 6 making it difficult and untimely to immediately ascertain the patient's current status on the day of the health evaluation visit. These findings were reviewed and acknowledged by the Administrator (Admin A) and Clinical Director (Staff B) during an interview on 10/20/2022 at 12:30 p.m.

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 ensure the individuals who furnished Home Health Aide services on its behalf met the competency evaluation requirements of this section by ensuring the required skills were evaluated by a Registered Nurse, who observed the Aide's performance of the required tasks with a patient and deemed competent prior to the provision of care for 1 (HHa #1) of 2 Home Health Aides whose files were reviewed, resulting in the potential for the provision of substandard care and unmet care needs. Findings include: On 10/20/22 at 10:00 a.m., a review of the Home Health Aide (HHa) personnel files revealed the following: HHa #1: Date of Hire (DOH) was 9/28/21. The "Competency Checklist" dated 9/23/21 did not include all of the required elements of this section. There was no documented evidence that HHa #1 was evaluated in areas that addressed all the required subject areas of 484.80(b)(3)(ix), specifically, bed bath, sponge, tub, and shower bath; Hair shampooing in sink, tub and bed; skin care; Toileting and elimination; (b)(3)(x) Safe transfer techniques and ambulation; and (b)(3)(xi) Normal range of motion and positioning, prior to the provision of care, as per this requirement. These findings were reviewed with the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22. The Administrator reported that the current forms used to evaluate the Home Health Aides are outdated and do not include all of the elements to meet this requirement.

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 Skilled Nursing prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to providing care in 2 (MR#'s 7, 15) of ___ records in which Home Health Aide services were ordered, from a total of 17 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: MR #15: The patient's start of care (SOC) was 10/1/22 with diagnoses that included Rectal Cancer and Iron Deficiency Anemia. The plan of care (POC) indicated the following Functional Limitations: Endurance, Dyspnea with moderate exertion, Safety Measures: Transfer Precautions, Fall Precautions, Supplies: Walker..." During the record review on 10/18/22 at 1:30 p.m., it was noted that the patient had a colostomy (a surgical operation in which a piece of the colon is diverted to an artificial opening in the abdominal wall so as to bypass a damaged part of the colon), and a Jackson-Pratt drain bulb (used to help empty excess fluid from the body after surgery). There was no mention of the patient's colostomy or drainage bulb on the Aide Care Plan. Further, there was no guidance on what actions should be taken regarding issues with either of the post-surgical devices. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 10/19/22 at 8:19 a.m. MR #17: The patient's SOC was 12/16/21 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Congestive Heart Failure (CHF) and Respiratory Failure. During the record review on 10/20/22 at 12:15 p.m., it was noted that the POC indicated the following: "Functional limitations: Endurance, Hearing, Dyspnea at rest..., Safety Measures: Fall Precautions, Transfer Precautions, Diabetic Precautions. Supplies: Walker, Oxygen..." During the review, it was noted that the "Aide Care Plan" failed to include all the above-mentioned safety precautions. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 10/20/22 at 1:00 p.m.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the discharge summary was complete, provided the patient's current health status at the time of discharge and identified the patients progress toward goals in 2 (MR#s 16, 17) of 5 records in which the patient was discharged from the Agency's services, from a total of 17 sampled records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR #16: The patients start of care (SOC) was 8/16/22 with diagnoses that included Pneumonitis, Congestive Heart Failure (CHF) and Dysphagia (difficulty swallowing). During the clinical record review on 10/19/22 at 10:48 a.m., it was noted that the referral for home care dated 8/15/22 ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and Speech Therapy (ST) services to be provided. During the review, the following was noted: The SN Discharge Summary dated 10/12/22 failed to include a summary that detailed the course of care provided and documented that goals were partially met. There was no mention of which goals were met versus (vs) unmet. The PT Discharge Summary dated 10/14/22 was completed/signed by the SN and documented, "continue with HEP (home exercise program), achieved maximum rehab possible, goals met..." There was no summary that detailed the course of care provided with responses and the status of the patient at discharge. Further, there was no mention of which goals were met vs unmet. The above disciplines failed to summarize the course of care provided with responses and indicate the patient's health status at discharge. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22 at 10:56 a.m. MR #17: The patient's SOC was 12/16/21 with diagnoses that included Hypertensive Heart Disease with Heart Failure, CHF and Chronic Respiratory Failure. During the clinical record review on 10/20/22 at 12:15 p.m. it was noted that the referral for home care dated 12/14/21 ordered SN, PT, OT and Home Health Aide services to be provided. During the review, the following was noted: The patient discharged from OT services on 1/19/22. The Summary failed to indicate which goals were met vs unmet. The PT Discharge Summary was void of a detailed course of care, status at the time of discharge and did not indicate which, if any, goals were met vs unmet. The SN Discharge Summary dated 2/7/22 did not detail the course of care provided and did not detail the patient's health status at the time of discharge. The summary stated, "Weight stable, Blood sugar this a.m. was WNL (within normal limits.) The summary did not include detailed information that would aid the Physician in determining the continuing care needs of the patient. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager and Quality Manager during an interview on 10/20/22.