Every finding on record at Three Rivers Health System Inc.

An unannounced standard Emergency Preparedness survey was conducted on 8/19/24 through 8/21/24 by the Michigan Department of Licensing and Regulatory Affairs. At the conclusion of the survey, Three Rivers Health Homecare and Hospice was found to be in compliance with the requirements for participation in Medicare at 42 CFR 484.102 – Emergency Preparedness.

An unannounced Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 8/19/24 to 8/21/24 at: Three Rivers Health Homecare and Hospice 711 S. Health Parkway Three Rivers, MI 49093 The agency does not operate any branch locations. Records reviewed: 3 active records with home visits, 3 active records without home visits, and 2 discharged records for a total of 8 records. At the conclusion of the survey, the agency was found to be out of compliance with the conditions of participation for home health agencies at 42 CFR Part 484.

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 record review and interview, the agency failed to ensure the comprehensive assessment was completed no later than 5 calendar days after the start of care in 1 (P-8) of 8 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Policy titled “Patient Assessment” (reviewed 4/2024) stated, “At the start of care, the initial comprehensive assessment SOC/ROC Assessment will be initiated within 48 hours of referral or return home, and completed within 5 days.” P-8: This 75-year-old patient was admitted to this agency on 8/5/24 with the diagnoses of a right knee infection following a total knee replacement, pyogenic (septic) arthritis, and congestive heart failure (CHF). During record review on 8/20/24, it was noted the original referral (dated 8/2/24) ordered services from skilled nursing, physical therapy, and occupational therapy. Upon further review of the record, it was noted the start of care was initiated on 8/5/24 and the occupational therapy evaluation was not done until 8/13/24 – 8 days after the start of care. There was no documentation or new orders to explain the late evaluation. The Administrator (Staff A) was queried regarding the findings during an interview on 8/21/24 at 8:15 AM. Staff A stated the occupational therapist is part-time with the home care agency and has been on vacation, so it has been hard to complete services on time. However, Staff A reported the agency is currently interviewing for a full-time occupational therapist to help fulfill the need. Staff A acknowledged the findings.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission for 4 (P-1, 2, 3, 8) of 8 records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients and assisting with developing the plan of care. Findings include: P-1: This 84-year-old patient was admitted to this agency on 8/5/24 with the diagnoses of chronic obstructive pulmonary disease (COPD) exacerbation, hypercalcemia (high levels of calcium in the blood), and weakness. During record review on 8/19/24, it was determined the physical therapist conducted the comprehensive assessment for the start of care on 8/5/24. During review of the comprehensive assessment, it was noted there was no manual muscle testing done to objectively assess the patient’s strength. P-2: This 64-year-old patient was admitted to this agency on 11/16/23 with the diagnoses of right hip arthritis, epilepsy, hypertension (high blood pressure), and type II diabetes. During record review on 8/20/24, it was determined the physical therapy evaluation was performed on 11/17/23. Upon review of the physical therapy evaluation, it was noted there was no manual muscle testing done to objectively assess the patient’s strength. Additionally, it was noted the Outcome Assessment Information Set (OASIS) dated 11/16/23 reported the patient was “4 – Chairfast, UNABLE to ambulate but is able to wheel self independently". The OASIS also noted the patient was “dependent” (unable/fully reliant on the assistance of others) for ambulating (walking) 10 feet at the start of care and the goal was to remain “dependent”. Upon review of the physical therapy evaluation completed the following day, the patient was able to ambulate 25 feet with supervision assistance. This information is conflicting and does not paint a clear picture of the patient’s current or previous function. P-3: This 66-year-old patient was admitted to this agency on 10/15/23 with the diagnoses of left above the knee amputation (AKA), thrombosis (blood clots), and type II diabetes. During record review on 8/20/24, it was determined the physical therapy evaluation was performed on 10/17/23. Upon review of the physical therapy evaluation, it was noted there was no manual muscle testing done to objectively assess the patient’s strength. P-8: This 75-year-old patient was admitted to this agency on 8/5/24 with the diagnoses of a right knee infection following a total knee replacement, pyogenic (septic) arthritis, and congestive heart failure (CHF). During record review on 8/20/24, it was determined the physical therapy evaluation was performed on 8/6/24. Upon review of the physical therapy evaluation, it was noted there was no manual muscle testing done to objectively assess the patient’s strength. The Physical Therapist (Staff D) was interviewed following a joint home visit on 8/21/24 at 10:30 AM. Staff D reported he sometimes does manual muscle testing but admits that he doesn’t always assess it specifically. Staff D agrees that strength should be measured on patient’s being treated for weakness to assess their current status and assess progress with the treatment plan. Findings were also reviewed and acknowledged by the Administrator (Staff A) during an interview on 8/21/24 at 8:15 AM.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications to determine any potential adverse effects and drug interactions in 5 (P-1, 2, 3, 6, 8) of 8 records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this agency. Findings include: P-6: The Start of Care (SOC) was dated 1/8/24. The Plan of Care (POC) identified diagnoses of Venous Insufficiency, Congestive Heart Failure and Diabetes Type 2. During record review on 8/20/24, it was noted that the Registered Nurse (RN) completed a comprehensive assessment on 1/8/24 and documented, “Drug Regimen Review: Yes, Issues found during review. Medication follow-up: Did the agency contact a physician by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues? Yes.” The agency's “Interactions” report located within the “Medication Profile”, generated by the Electronic Medical Record (EMR) identified 2 potentially severe drug to drug interactions, Trimethoprim and Losartan, and Dextromethorphan and Tramadol. There was no documented evidence that a drug interaction review had in fact been conducted to identify any adverse reactions or effects, or documented evidence that the physician had been notified of the above findings. This finding was reviewed with and acknowledged by the Staff A (Administrator) during an interview on 8/21/24 at 10:50 am. **Policy titled “Medication Oversight” (revised 4/2024) stated, “E. A Registered Nurse will assess all medications a patient may be taking to identify possible duplicate or ineffective drug therapy, significant side effects, drug allergies, adverse effects, and drug reaction. Any problem will be documented in the medical record and reported to the physician.” P-1: This 84-year-old patient was admitted to this agency on 8/5/24 with the diagnoses of chronic obstructive pulmonary disease (COPD) exacerbation, hypercalcemia (high levels of calcium in the blood), and weakness. During record review on 8/19/24, it was noted the Outcome and Assessment Information Set (OASIS) indicated a drug regimen review was completed under “M2010 Drug Regimen Review” and “Yes - Issues found during review.” Additionally, it was noted on the OASIS under “M2003 Medication Follow-up” that the agency completed the “prescribed/recommended actions in response to the identified potential clinically significant medication issues” regarding contacting the physician. A drug interaction report run by the agency’s electronic medical record (EMR) system identified 5 “Major” drug to drug interactions. There was no documented evidence the physician was contacted to reconcile the potentially clinically significant interactions identified according to agency policy. P-2: This 64-year-old patient was admitted to this agency on 11/16/23 with the diagnoses of right hip arthritis, epilepsy, hypertension (high blood pressure), and type II diabetes. During record review on 8/20/24, it was noted the OASIS indicated a drug regimen review was completed under “M2010 Drug Regimen Review” and “Yes - Issues found during review.” Additionally, it was noted on the OASIS under “M2003 Medication Follow-up” that the agency completed the “prescribed/recommended actions in response to the identified potential clinically significant medication issues” regarding contacting the physician. A drug interaction report run by the agency’s EMR system identified 13 “Severe” drug to drug interactions and multiple “Major” drug to drug interactions. There was no documented evidence the physician was contacted to reconcile the potentially clinically significant interactions identified according to agency policy. P-3: This 66-year-old patient was admitted to this agency on 10/15/23 with the diagnoses of left above the knee amputation (AKA), thrombosis (blood clot), and type II diabetes. During record review on 8/20/24, it was noted the OASIS indicated a drug regimen review was completed under “M2010 Drug Regimen Review” and “Yes - Issues found during review.” Additionally, it was noted on the OASIS under “M2003 Medication Follow-up” that the agency completed the “prescribed/recommended actions in response to the identified potential clinically significant medication issues” regarding contacting the physician. A drug interaction report run by the agency’s EMR system identified 4 “Severe” drug to drug interactions and >25 “Major” drug to drug interactions. There was no documented evidence the physician was contacted to reconcile the potentially clinically significant interactions identified according to agency policy. The Administrator (Staff A) was queried regarding the agency's practice for reporting drug interactions found on the medication review during an interview on 8/21/24 at 8:15 AM. Staff A stated the agency reports clinically significant interactions to the physician to reconcile, however, she was unable to define what types of interactions that included in regard to the wording in the drug interaction report. When asked about communication with the physician regarding the drug interactions identified, Staff A stated staff often document details regarding the reconciliation in a communication note or the next daily note to reflect any new orders or changes to the current regimen. However, Staff A was unable to find this information for the patients above and acknowledged the findings. P-8: This 75-year-old patient was admitted to this agency on 8/5/24 with the diagnoses of a right knee infection following a total knee replacement, pyogenic (septic) arthritis, and congestive heart failure (CHF). During record review on 8/20/24, it was noted the OASIS indicated a drug regimen review was completed under “M2010 Drug Regimen Review” and “No – No issues found during review.” A drug interaction report run by the agency’s EMR system identified 1 “Severe” drug to drug interaction and 24 “Major” drug to drug interactions. Staff A was unable to provide an explanation of why the OASIS indicated no issues were found during review and acknowledged the findings during an interview on 8/21/24 at 8:15 AM.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the Plan of Care included objectively measurable and individualized goals in 4 (P-4, 5, 6, 7) of 8 records reviewed; safety precautions in 4 (P-2, 3, 6, 7) of 8 records reviewed; and covered all pertinent interventions with reportable parameters in 1 (P-7) of 8 records reviewed, resulting in patients not receiving care specific to their needs and the potential for poor patient outcomes. Findings included: P-2: This 64-year-old patient was admitted to this agency on 11/16/23 with the diagnoses of right hip arthritis, epilepsy, hypertension (high blood pressure), and type II diabetes. During record review on 8/20/24, it was determined the plan of care (POC) failed to include diabetic precautions under safety measures. P-3: This 66-year-old patient was admitted to this agency on 10/15/23 with the diagnoses of left above the knee amputation (AKA), thrombosis (blood clots), and type II diabetes. During record review on 8/20/24, it was determined the POC failed to include diabetic precautions under safety measures. Findings were reviewed with and acknowledged by the Administrator (Staff A) during an interview on 8/22/24 at 8:15 AM. **Agency Policy: "Plan of Care," (Last Approved 04/2024). The policy states, "C. The Plan of Care must include the type of services to be provided and the frequency and duration of these services, including: 2. Specific procedures and treatments, including frequency and duration.” **Agency Policy: "Clinical Records - Documentation," (Last Approved 01/2024). The policy states, "8. Plan of Care (485) which includes but is not all inclusive of: h. DME (Durable Medical Equipment) and supplies. j. Safety measures.” P-6: The Start of Care (SOC) was dated 1/8/24. The Plan of Care (POC) identified diagnoses of Venous Insufficiency, Congestive Heart Failure and Diabetes Type 2. During record review on 8/20/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Pt (Patient) free from falls.” Additionally, another goal stated, “Pt verbalize changing peri pad when damp.” Additionally, the POC failed to include the safety measures of diabetic precautions. The agency failed to ensure the POC covered all pertinent treatments and interventions with measurable goals and safety measures. P-7: The Start of Care (SOC) was dated 2/17/23. The Plan of Care (POC) identified diagnoses of Cystostomy, Chronic Obstructive Pulmonary Disease and Diabetes Type 2. During record review on 8/19/24, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Indwelling catheter/drainage system patent and functioning without complication.” Additionally, another goal stated, “Patient/caregiver demonstrate proper administration of inhalation therapy.” Additionally, the POC failed to include the safety measures of diabetic precautions. Furthermore, the POC failed to include any diabetic supplies. On 6/13/24, the Registered Nurse documented, “Diabetes: Glucose Monitoring: Blood Glucose Monitor.” Lastly, the POC failed to include an intervention to assess vital signs with reportable parameters. The agency failed to ensure the POC covered all pertinent treatments and interventions with measurable goals, safety precautions, diabetic supplies and reportable parameters. These findings were reviewed with and acknowledged by the Staff A (Administrator) during an interview on 8/21/24 at 10:30 am. P-4: The Start of Care was dated 7/11/24. The Plan of Care for the certification period 7/11/2024 to 9/8/2024 identified diagnoses of Diabetes Type 2 with foot ulcer; Diabetes Type 2 with diabetic neuropathy; non-pressure ulcer of left heel and midfoot with fat layer exposed; Hypertension; Presence of coronary angioplasty implant with bypass graft. Upon review of the record on 8/20/24, it was noted the goals on the Plan of Care were not objectively measurable to determine the patient's progress towards achieving the goals. Examples included: "Patient/Caregiver will verbalize understanding and demonstrate compliance with recommended ADA diet. This goal is not objectively measurable to determine the patient's progress towards achieving the goal. P-5: The Start of Care was dated 8/10/2024. The Plan of Care for the certification period 8/10/24 to 10/8/24 identified diagnoses of Acute and subacute infective endocarditis; Sepsis due to specified staphylococcus; Encounter for surgical aftercare following surgery on the circulatory system; Acute respiratory failure with hypoxia; Congestive Heart Failure and Diabetes Type 2. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient's progress towards achieving the goals. Examples include: "Patient/Caregiver verbalize understanding of disease process including prognosis, signs/symptoms, complications, effect of disease on body systems and what to report; Patient/Caregiver will verbalize understanding of anticoagulant precautions, signs/symptoms of bleeding to report; Patient/Caregiver understands and adheres to prescribed diet." These goals are not objectively measurable to determine the patient's progress towards achieving the goals. These findings were reviewed and acknowledge by Staff A (Administrator) during an interview on 8/21/24 at 11:30 am.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained all assessments from the most recent home health admission in 1 (P-8) of 8 records reviewed, resulting in the potential for unmet or overlooked care needs. Findings include: **Policy titled “Clinical Records – Documentation” (revised 1/2024) stated, “9. Documentation must be timely and accurate. Staff are to document all direct care delivery during the visit immediately after the visit, on the day service is rendered. Documentation must be incorporated into the clinical record now less often than weekly.”’ P-8: This 75-year-old patient was admitted to this agency on 8/5/24 with the diagnoses of a right knee infection following a total knee replacement, pyogenic (septic) arthritis, and congestive heart failure (CHF). During record review on 8/20/24, it was noted the occupational therapist evaluated the patient on 8/13/24. As of 8/21/24 at 8:30 AM, the evaluation was not completed – 8 days after the visit took place. During the entrance interview on 8/19/24 at 10:00 AM, the Administrator (Staff A) was asked what the expectation is for completion of documentation. Staff A reported her expectation is 48 hours, however, later provided the policy above. During a second interview on 8/21/24 at 8:15 AM, Staff A was shown missing documentation for P-8. Staff A was unable to provide an explanation for the late/missing documentation and acknowledged the findings.

On 8/10/21 through 8/13/21, the Michigan Department of Licensing and Regulatory Affairs conducted a recertification survey at Three Rivers Health Homecare and Hospice. This was a standard survey. The requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness were not reviewed.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 8/10/2021 through 8/13/21 at: Three Rivers Health Homecare and Hospice 711 S. Health Parkway Three Rivers, MI 49093 This agency has no branch sites. Records Reviewed: 4 records with home visits; 6 records without home visits, for a total of 10 records reviewed. At the conclusion of the survey the agency was found to be out of compliance with standard level deficiencies for the conditions of participation for home health agencies at: 42 CFR Part 484.

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 #6, 7 and 8) of 5 patients observed during home visits, from a total of 10 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, resulting lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: MR #6: The patient's start of care (SOC) was 5/16/21 with diagnoses that included COPD (chronic obstructive pulmonary disease) and Heart Failure. During the clinical record review on 8/11/21 at 8:41 a.m., it was noted that Skilled Nursing (SN) and Home Health Aide (HHa) services were ordered to be provided. On 8/10/21 at 12:45 p.m., a 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 calendar of proposed visits to be made by the RN. MR #7: The patient's SOC was 7/23/21 with diagnoses that included COPD, Chronic Pulmonary Edema and Respiratory Failure. During the clinical record review on 8/11/21 at 9:12 a.m., it was noted that SN and Medical Social Work (MSW) services had been ordered to provide care. On 8/10/21 at 1:30 p.m., during a scheduled home visit with the Social worker (MSW #1), it was noted that the patient's admission packet was void of a calendar of proposed visits to be made by the SN and MSW. The agency failed to ensure a calendar of proposed visits had been provided at the SOC to assist the patient with participating in planning his care and daily routine. MR #8: The patient's SOC was 7/7/21 with diagnoses that included Pneumonia, Respiratory Failure and Congestive Heart Failure. During the record review on 8/11/21 at 10:27 a.m., it was noted that SN, PT and Occupational Therapy (OT) services were ordered to be provided. On 8/10/21 at 3:30 p.m., during a joint home visit with the Physical Therapist, (PT #1), the patient's admission packet was reviewed. During the review, it was noted that the patient's admission packet was void of a calendar of proposed visits to be made by the SN, PT and OT. The agency failed to ensure a calendar of proposed visits had been provided at the SOC to assist the patient with participating in planning his care and daily routine. The findings in the above records were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:30 a.m.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care for 1 (MR# 9) of 3 patients who was discharged from the agency's services, resulting in the patient being denied the right to appeal the decision to end covered services, and the potential for unmet care needs. Findings include: MR #9: The patient's start of care (SOC) was 5/1/21 with diagnoses that included Atrial fibrillation, Alzheimer's, Dementia, Weakness and Heart Failure. The record review, conducted on 8/11/21 at 12:21 p.m., revealed the following: The plan of care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and Home Health Aide services to be provided. The patient discharged from the agency's services on 5/26/21. The "Notice of Medicare Non-Coverage" documented, "The effective date coverage of your current Home Health services will end 5-26-21." This was the same day the patient was discharged from the agency's services. Further review revealed the patient also signed the notice on 5/26/21. The Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the agency terminating on-going care. The above findings were reviewed with and acknowledged by the Administrator (Adm #) during a telephone interview on 8/12/21 at 8:34 a.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects, and failed to provided documented evidence that the physician was notified of identified drug interactions in 4 (MR's # 3, 7, 8, 9) of 10 sampled records reviewed, resulting in the potential for harmful medication effects for all 81 patients currently serviced by this Agency. Findings include: MR #7: The patient's start of care (SOC) was 7/23/21 with diagnoses that included COPD (Chronic Obstructive Pulmonary Disease), Pulmonary Edema and Respiratory Failure. On 8/11/21 at 9:12 a.m., during a review of the clinical record, it was noted that section M2001 of the Initial Comprehensive Assessment/Oasis dated 7/23/21, completed by the Registered Nurse, indicated "No issues found during review." The patient's 20 prescribed medications were entered into "Drugs.com" (online drug interaction checker) and revealed: 1 Major drug to drug interaction, 16 Moderate drug to drug interactions, 5 drug to food interactions and 3 duplicate drugs. Additionally, the agency's Drug Interaction Report, generated by the Electronic Medical Record (EMR) system identified 3 potentially severe drug to drug/drug to food interactions. There was no documented evidence that an actual drug review had been conducted or that the Physician had been notified of the untoward reactions. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:35 a.m. MR #8: The patient's SOC was 7/7/21 with diagnoses that included Pneumonia, Respiratory Failure with Hypoxia, Congestive Heart Failure (CHF), and Parkinson's Disease. During the record review on 8/11/21 at 10:27 a.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 7/23/21, completed by the Registered Nurse, indicated "Yes - Issues found during review." The Agency's Drug interaction Report identified potentially Severe drug interactions. Upon further review, there was no documented evidence that the agency had notified the Physician of the identified untoward interactions. Further review revealed that the patient was transferred to an inpatient facility on 7/11/21 and resumed care on 7/22/21. The Resumption of Care assessment indicated there were issues found during the review. However, there was no documented evidence that the Physician had been made aware of the identified interactions. These findings were reviewed with and acknowledged by Adm #1 during a telephone interview on 8/12/21 at 8:35 a.m. MR #9: The patient's SOC was 5/1/21 with diagnoses that in included Atrial Fibrillation, Alzheimer's, Dementia and Heart Failure. During the record review on 8/11/21 at 12:21 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 5/1/21, completed by the Registered Nurse, indicated "Yes - Issues found during review." The Agency's Drug interaction Report identified potentially Severe drug interactions. Upon further review, there was no documented evidence that the agency had notified the Physician of the identified untoward interactions. These findings were reviewed with and acknowledged by Adm #1 during an interview on 8/12/21 at 8:35 a.m. MR#3: The Start of Care (SOC) was dated 7/14/21. The Plan of Care (POC) identified diagnoses of Diverticulitis, Gastrointestinal Hemorrhage and Chronic Obstructive Pulmonary Disease (COPD). During record review on 8/11/21, section M2001 of the "Comprehensive Assessment" dated 7/14/21 and completed by the registered nurse (RN), documented "No issues found during review." The patient's 21 prescribed medications were entered in "Drugs.com" (online pharmaceutical encyclopedia used to provide drug information to healthcare professionals) and revealed the following: 5 Major drug to drug interaction, 23 Moderate drug to drug interactions, 7 drug to food interactions and 4 duplicate drugs. Furthermore, the agency's Drug Interaction Report, generated by the Electronic Medical Record (EMR) identified 5 potentially severe drug to drug interactions. There was no documented evidence, during the 8/11/21 clinical record review, that a drug interaction review had in fact been conducted to identify any adverse reactions or effects, or documented evidence that the physician had been notified of the above findings. The Adm #1 was questioned on 8/13/21 at 8:45 am and confirmed the finding.

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 transfer/discharge summaries were complete, detailed, and provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 2 (MR# 8, 9) of 2 records in which the patient was discharged/transferred from the agency's services, from a total of 10 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR #8: The patient's Start of Care (SOC) was 7/7/21 with diagnoses that included Pneumonia, Respiratory Failure, Congestive Heart Failure and Parkinson's Disease. The The record revealed that the patient required continuous Oxygen (O2) via nasal cannula due to shortness of breath on exertion. The Plan of Care (POC) ordered the skilled nurse (SN) to assess the patient's Oxygen levels every visit. On 8/11/21 at 10:27 a.m., during the clinical record review, it was also noted that the patient was transferred to the hospital on 7/11/21. The "Transfer Summary" was dated 7/11/21, was completed by the SN. The section titled "Summary" merely restated the patient's diagnoses and documented, "Admitted to Bronson hospital for CHF And pneumonia." [sic] There were no vital signs, current health status, O2 levels, or any information that detailed what the patient's symptoms were that required the transfer with resultant hospitalization. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:35 a.m. MR #9: The patient's SOC was 5/1/21 with diagnoses that included Atrial Fibrillation, Alzheimer's, Weakness and Heart Failure. The POC ordered SN, Physical Therapy (PT), Occupational Therapy (OT) and Home Health Aide services to be provided. On 8/11/21 at 12:21 p.m. during the clinical record review, it was noted that the patient discharged from OT and PT on 5/19/21 and discharged from SN services on 5/26/21. The "PT Discharge Summary" dated 5/19/21 offered no summary of the course of care provided with responses, and gave no information on which goals, if any were met versus (vs) unmet. Further, the summary failed to include a PT quantitative assessment of the patient's status (flexion, reach, distance walking...) post therapy services. The section titled, "Discharge Condition" was left blank. The section titled, "Patient/Family Discharge Instructions" was also left blank. The PT Discharge Summary failed to meet the requirements of this section. The SN "Discharge Summary" dated 5/26/21 was vague and stated, "Pt admitted for homecare. He has therapy referral also. Pt and wife instructed on disease process for cardiac status,(CHF and A-fib) and memory recal issue. Pt and wife instructed to monitor wt, report increased edema and methods to help prevent falls..." [sic] The Summary failed to detail the course of care provided along with responses, any continuing needs, if any, and which, if any, goals were met vs unmet. The section titled, "Discharge Condition" was left blank. The section titled, "Patient/Family Discharge Instructions" was also left blank. There was no final documented weight, vitals signs or measurement of edema. During the record review, it was noted that the POC ordered SN to "assess pain level every visit." There was no mention of the patient's pain level at the time of discharge. The SN Discharge Summary failed to meet the requirements of this section. The identified deficiencies were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview conducted on 8/12/21 at 8:35 a.m.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient for 3 (MR's # 8, 9 and 10) records, from a total of 10 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: MR #8: The patient's start of care (SOC) was 7/7/21 with diagnoses that included Pneumonia, Respiratory Failure, Congestive Heart Failure and Parkinson's Disease. During the clinical record review on 8/11/21 at 10:27 a.m., it was noted that the plan of care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. The Plan of Care (POC) ordered SN to assess the patient's Oxygen (O2) saturation every visit, assess weight change, monitor weight. There were no reportable parameters set for the patient's O2 levels or weight in which to report to the Physician. Additionally, there were no goals related to the patient's weights or O2 levels. The Plan of Care failed to include all the required elements, as per this requirement, in order to meet the individualized needs of the patient. MR #9: The patient's SOC was 5/1/21 with diagnoses that included Atrial Fibrillation, Alzheimer's, Weakness and Heart Failure. During the clinical record review on 8/11/21 at 12:21 p.m., it was noted that the POC ordered SN, PT, Occupational Therapy (OT) and Home Health Aide (HHa) services to be provided. The POC ordered SN to assess for the presence of peripheral edema, assess pain level every visit and assess the patient's respiratory status. There were no set reportable parameters in which to notify the Physician for pain, or edema. Additionally, there were no associated goals for pain, edema or the patient's respiratory status. The SN goals were vague and stated, ""Patient can verbalize understanding of 3 symptoms of disease process..." The Plan of Care failed to include all the required elements, as per this requirement, in order to meet the individualized needs of the patient. MR #10: The patient's SOC was 4/19/21 with diagnoses that included Dementia, Chronic Kidney Disease and Congestive Heart Failure. During the clinical record review on 8/11/21 at 1:59 p.m., it was noted that the POC ordered SN and Medical social Work (MSW) services to be provided. It was further noted that the patient discharged from the agency's services on 5/6/21. The POC ordered SN to assess history of falls, assess for the presence of peripheral edema, assess O2 level every visit... The SN goals were vague and stated, "The patient verbalize understanding of disease process..." POC failed to include all the required elements, as per this requirement, in order to meet the individualized needs of the patient. The above records were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:35 a.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 services were provided only as ordered by the physician in 1 of 10 (MR# 3) records reviewed, resulting in the potential for the provision of inappropriate care and services. Findings include: MR#3: The Start of Care (SOC) was dated 7/14/21. The Plan of Care (POC) identified diagnoses of Diverticulitis, Gastrointestinal Hemorrhage and Chronic Obstructive Pulmonary Disease (COPD). During record review on 8/11/21, it was noted the POC contained the following reportable heart rate parameters: Pulse less than 60. On 7/28/21, the Occupational Therapist (OT) documented a pulse of 51 and "Notified RN (Registered Nurse)." There was no documented evidence that the RN notified the physician of the low heart rate reading. The Adm #1was questioned on 8/13/21 at 9:15 am and confirmed the findings stating, "There was no communication note documented. They should have put a communication note in."

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 3 (MR#'s 6, 7 and 8) of 3 patients observed during home visits, with a Medication Profile that included the names, dosages and frequencies of the patient's prescribed medications, in plain language, from a total of 10 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: MR #6: The patient's start of care (SOC) was 5/16/21 with diagnoses that included COPD (chronic obstructive pulmonary disease) and Heart Failure. During the clinical record review on 8/11/21 at 8:41 a.m., it was noted that Skilled Nursing (SN) and Home Health Aide (HHa) services were ordered to be provided. On 8/10/21 at 12:45 p.m., a joint 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 in the patient's admission packet that listed the patient's prescribed medications, dosages and side effects. The patient was queried, and expressed no knowledge of ever having a Medication list provided by the Agency. MR #7: The patient's SOC was 7/23/21 with diagnoses that included COPD, Chronic Pulmonary Edema and Respiratory Failure. During the clinical record review on 8/11/21 at 9:12 a.m., it was noted that SN and Medical Social Work (MSW) services had been ordered to provide care. On 8/10/21 at 1:30 p.m., during a scheduled joint home visit with the Social worker (MSW #1), it was noted that the patient's admission packet was void of a Medication Profile that listed all the patients prescribed medications. During the visit, the patient was queried, and expressed no knowledge of having a Medication list provided by the Agency and stated, "This (Folder) is all I received." MR #8: The patient's SOC was 7/7/21 with diagnoses that included Pneumonia, Respiratory Failure and Congestive Heart Failure. During the record review on 8/11/21 at 10:27 a.m., it was noted that the patient was ordered to receive SN, PT and Occupational Therapy (OT) services. On 8/10/21 at 3:30 p.m., during a joint home visit with the Physical therapist, (PT #1), the patient's admission packet was reviewed. During the review, it was noted that there was no Medication Profile in the patient's folder that listed all his prescribed medications, dosages, frequencies and side effects. The patient's wife was queried, and expressed no knowledge of having a Medication Profile. The deficiencies identified in the above records were reviewed with and acknowledged by the Administrator (Adm #1) and during a telephone interview on 8/12/21 at 8:30 a.m.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure the Home Health Aide followed accepted standards of practice in Infection Control for 1 (MR #6) of 1 patient observed during a home visit, from a total of 10 records reviewed, resulting in the potential for the development and spread of infection. Findings include: MR #6: The patient's start of care was 5/16/21. The certification period of review was 7/15/21 through 8/13/21 with diagnoses that included COPD (Chronic Obstructive Pulmonary Disease) and congestive Heart Failure. During the clinical record review on 8/11/21 at 8:41 a.m., it was noted that the plan of care ordered Home Health Aide (HHa) services to be provided 2x/wk. x 8 wks. On 8/10/21 at 12:45 p.m., a joint home visit was conducted with HHa #1. During the visit, HHa #1 was observed assisting the patient with a shower. during the shower, HHa #1 pulled her face mask downward and wiped sweat from her brow. HHa #1 was wearing gloves used to assist the patient with her shower. Additionally, HHa #1 threw the patient's bath tile over her left arm, making contact with her uniform. After getting the patient from the shower and drying the patient's skin, HHa # proceeded to hang the patient's wet/soiled towel on the shower curtain rod. The towel made contact with HHa #1's skin and uniform. it was further observed that throughout the provision of care, HHa #1 consistently made contact with her uniform as her hand sanitizer and gloves were in a deep side pocket of her pants. The above observations were discussed with and acknowledged by HHa #1 upon completion of the visit. The above findings were also reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:35 a.m.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview it was determined that the agency failed to ensure the professional staff provided ongoing reassessment in 1 of 3 records (MR# 4) in which the patient had Diabetes Type 2, out of a total of 10 records reviewed, which resulted in the potential for unidentified patient needs. Findings include: Agency Policy: "Patient Assessment" (Revised 10/1995) stated, "Ongoing reassessment will be performed at each visit to determine the patient's response to care, and to determine any significant change in the patient's condition, diagnosis, medications, environment, or support system. The scope and intensity of reassessments will be determined by the patient's diagnosis, condition, need, and desire for care and services, response to previous care, and the service setting. A patient's nursing and therapy needs should be regularly re-evaluated during the certification period, but at least every 60 days." MR#4: The Start of Care (SOC) was dated 6/3/21. The Plan of Care (POC) identified diagnoses of Right Lower Leg Wound, Diabetes Type 2 and Congestive Heart Failure (CHF). During record review on 8/11/21, it was noted that the Skilled Nurse (SN) completed a visit on 8/5/21 at 11:45am to 12:40pm. The SN documented the patient's blood sugar at 431, notified the physician, then patient administered 8 units of Novolog per sliding scale. That evening, from 6:45pm to 7:00pm, the same SN completed a PRN (as needed) visit due to "Assess wound vac." The SN failed to reassess and document the patient's blood sugar readings. The Adm #1was questioned on 8/13/21 at 9:00 am and confirmed the findings stating, "The nurse should have documented the patient's blood sugar readings."

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 observation, interview and record review, it was determined the Agency failed to ensure the Skilled Nurse prepared clear written patient care instructions for the Home Health Aide regarding client needs, visit frequency and frequency of tasks to be performed in 2 (MR#'s 6 and 9) of 3 records in which Home Health Aide services were ordered, from a total of 10 sampled records reviewed, resulting in no guidance on what services to provide, the potential for the provision of unsafe care and unmet care needs. Findings include: MR #6: The patient's start of care (SOC) was 7/16/21 with diagnoses that included COPD (Chronic Obstructive Pulmonary Disease) and Congestive Heart Failure. The Plan of Care (POC) instructed Home Health Aide (HHa) services to be provided at a frequency of 2x/wk. x 8 wks. During the clinical record review on 8/11/21 at 8:41 a.m., the Aide "Care Plan" was reviewed. The plan failed to include the Aide visit frequency and the frequency in which tasks were to be performed. Additionally, the plan was not clear and stated, "Hygiene: Bath: Shower Chair: Assist patient to shower..." The Nurse failed to provide clear guidance for the provision of care. MR #9: The patient's SOC was 5/1/21 with diagnoses that included Atrial Fibrillation, Alzheimer's, Dementia, Weakness and Heart Failure. The POC ordered HHa services to be provided at a frequency of 2x/wk. x 8 wks. and listed the following safety measures: "Fall precautions, Bleeding precautions, transfer precautions, skin breakdown precautions and universal precautions." During the clinical record review on 8/11/21 at 12:21 p.m., it was noted that the Aide Care Plan failed to include the Aide visit frequency and the frequency in which tasks were to be performed. Additionally, the plan did not include Bleeding precautions, transfer precautions, skin breakdown precautions and universal precautions. The Nurse failed to provide clear guidance for the provision of care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:30 a.m.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the registered nurse failed to supervise the home health aides' services no less frequently than every 14 days for 1 of 3 records reviewed (MR# 3) with home health aide services, for a potential of unmet and unsafe patient care. Findings include: MR#3: The Start of Care (SOC) was dated 7/14/21. The Plan of Care (POC) identified diagnoses of Diverticulitis, Gastrointestinal Hemorrhage and Chronic Obstructive Pulmonary Disease (COPD). During record review on 8/11/21, it was noted that the Home Health Aide (HHa) completed 4 visits on 7/19/21, 7/23/21, 7/27/21, and 8/3/21. There was no documented evidence the RN completed a supervisory visit from 7/19/21 to 8/3/21, no less frequently than every 14 days, to supervise the home health aide services. The Adm #1 was questioned on 8/13/21 at 8:50 am and confirmed the findings stating, "Correct, we missed the aide supervision."

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical notes were accurate for 1 of 10 (MR# 4) records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: MR#4: The Start of Care (SOC) was dated 6/3/21. The Plan of Care (POC) identified diagnoses of Right Lower Leg Wound, Diabetes Type 2 and Congestive Heart Failure (CHF). During record review on 8/11/21, it was noted the Skilled Nurse (SN) failed to document the patient's blood sugars on: 6/5/21, 6/12/21, 6/26/21, 7/3/21, 7/22/21, 7/24/21, 7/29/21, 8/5/21 and 8/7/21. 9 of the 20 SN visits completed failed to document blood sugar for this diabetic patient every visit. The Adm #1was questioned on 8/13/21 at 8:45 am and confirmed the findings stating, "The blood sugars are to be documented every visit."

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the transfer/discharge summaries were complete, provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 2 (MR# 8, 9) of 2 records in which the patient was discharged/transferred from the agency's services, from a total of 10 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR #8: The patient's Start of Care (SOC) was 7/7/21 with diagnoses that included Pneumonia, Respiratory Failure, Congestive Heart Failure and Parkinson's Disease. The The record revealed that the patient required continuous Oxygen (O2) via nasal cannula due to shortness of breath on exertion. The Plan of Care (POC) ordered the skilled nurse (SN) to assess the patient's Oxygen levels every visit. On 8/11/21 at 10:27 a.m., during the clinical record review, it was also noted that the patient was transferred to the hospital on 7/11/21. The "Transfer Summary" was dated 7/11/21, was completed by the SN. The section titled "Summary" merely restated the patient's diagnoses and documented, "Admitted to Bronson hospital for CHF And pneumonia." [sic] There were no vital signs, current health status, O2 levels, or any information that detailed what the patient's symptoms were that required the transfer with resultant hospitalization. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview on 8/12/21 at 8:35 a.m. MR #9: The patient's SOC was 5/1/21 with diagnoses that included Atrial Fibrillation, Alzheimer's, Weakness and Heart Failure. The POC ordered SN, Physical Therapy (PT), Occupational Therapy (OT) and Home Health Aide services to be provided. On 8/11/21 at 12:21 p.m. during the clinical record review, it was noted that the patient discharged from OT and PT on 5/19/21 and discharged from SN services on 5/26/21. The "PT Discharge Summary" dated 5/19/21 offered no summary of the course of care provided with responses, and gave no information on which goals, if any were met versus (vs) unmet. Further, the summary failed to include a PT quantitative assessment of the patient's status (flexion, reach, distance walking...) post therapy services. The section titled, "Discharge Condition" was left blank. The section titled, "Patient/Family Discharge Instructions" was also left blank. The PT Discharge Summary failed to meet the requirements of this section. The SN "Discharge Summary" dated 5/26/21 was vague and stated, "Pt admitted for homecare. He has therapy referral also. Pt and wife instructed on disease process for cardiac status,(CHF and A-fib) and memory recal issue. Pt and wife instructed to monitor wt, report increased edema and methods to help prevent falls..." [sic] The Summary failed to detail the course of care provided along with responses, any continuing needs, if any, and which, if any, goals were met vs unmet. The section titled, "Discharge Condition" was left blank. The section titled, "Patient/Family Discharge Instructions" was also left blank. There was no final documented weight, vitals signs or measurement of edema. During the record review, it was noted that the POC ordered SN to "assess pain level every visit." There was no mention of the patient's pain level at the time of discharge. The SN Discharge Summary failed to meet the requirements of this section. The identified deficiencies were reviewed with and acknowledged by the Administrator (Adm #1) during a telephone interview conducted on 8/12/21 at 8:35 a.m.