Every finding on record at Serenity Home Health Care Agency, LLC

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the agency contracting all patient services. Findings include: During record review on 12/3/21, Admin-A (Administrator) provided documentation of staff lists that show the agency contracts with 2 staffing companies. Contractor 1 provides Physical Therapy (PT) services. Contractor 2 provides PT, Occupational Therapy, Skilled Nursing, Speech Therapy, Medical Social Worker, and Home Health Aide services. The agency also utilizes the services of 1 individual who is a 1099 independent contractor (LPN-C, who is also the Alternate Administrator and the Alternate Clinical Manager). All services offered by the agency are either contracted or provided by 1099 independent contractors. There was no documented evidence the agency provides at least one qualifying service directly by agency employees. The ADM#1 was questioned on 12/3/21 at 1:45 pm and confirmed the findings stating, "I will make sure to update the contract to remove Skilled Nursing and to make LPN-C a W-2 employee."

The following standard level deficiencies were identified during the Medicare Emergency Preparedness survey conducted by the Michigan Department of Licensing and Regulatory Affairs (LARA) from 6/8/21 to 6/10/21 at: Serenity Home Health Agency 29500 Telegraph Rd. Suite 200 Southfield, MI 48034

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to incorporate an individual Emergency Preparedness Plan into the Comprehensive Patient Assessment for 7 of 7 records reviewed (MR # 1-7) for Emergency Preparedness from a total of 7 sampled records reviewed, resulting in the potential for negative patient outcomes in the event of an actual emergency for the agency's current 49 patients. Findings include: MR's #1-7: During record review on 6/8/21 through 6/10/21, it was noted that the Individual Patient Emergency Preparedness Plan was not complete. The section titled "Relevant Home Care Information" was blank. The DON#1 was questioned on 6/10/21 at 10:45 am and confirmed the findings stating, "Yes, those are not completed correctly." The agency failed to incorporate an individual Emergency Preparedness Plan into the Comprehensive Patient Assessment.

Names and Contact Information CFR(s): 484.102(c)(1) [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all patient's physician, which had the potential to negatively affect the health and safety of the 49 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: On 6/9/21, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with DON#1 on 6/10/21 at 10:15 am and confirmed the findings stating, "Yes, the physicians contact information for the patients is not there."

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/8/2021 through 6/10/2021 at: Serenity Home Health Agency 29500 Telegraph Rd. Suite 200 Southfield, MI 48034 At the time of the survey, the agency did not operate any branch offices or subunits. Clinical records reviewed for this survey included 2 records with home visits, 5 records without home visits which included 2 discharge records and 3 active records for a total of 7 records reviewed. The agency failed to arrange a Third surveyor home visit as requested by the survey team. Condition level deficiencies were identified at: 42 CFR §484.55 Comprehensive Assessment of Patients 42 CFR §484.60 Care Planning, Coordination, Quality of Care 42 CFR §484.65 Quality Assessment/Performance Improvement 42 CFR §484.75 Skilled Professional Services 42 CFR §484.105 Organization and Administrative of Services 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 document review and interview, the agency failed to furnish home health aide services as needed in 1 of 3 (MR# 1) records reviewed with aide services ordered, resulting in an unnecessary financial burden placed on the patient. Findings include: Agency policy "Patient Bill of Rights & Responsibilities" (Revised January 2020) 12.1.1 stated, "7. Agency maintains documentation in the patient's medical record demonstrating compliance with informing patient about rights... Receive all services in the plan of care." MR#1: This patient was admitted to the agency on 4/14/2021 with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. The referral for home care dated 4/6/21 ordered skilled nursing, physical therapy, occupational therapy, social work, and home health aide (HHa) services. The plan of care dated 4/14/2021 documented HHa services as being refused. On 6/9/2021 at 4:35 PM, the patient was called for an interview to ascertain the extent of services furnished by the Home Health Agency. During the interview, it was discovered the patient was paying out of pocket (non-covered cost) for HHa services from "Homestead Senior Care" during the following times: 8 AM-5 PM on weekends, 8 AM-4 PM Monday through Friday, and 10 PM-8 AM every night. When queried why HHa services were refused when she was paying out of pocket for a covered benefit, the patient replied, "I thought there wasn't a need since I had all my times covered already." During review of the clinical record on 6/9/21, documentation concerning education or insights given to explain why the patient would choose to pay for a covered service was not found. These findings were reviewed with and acknowledged by the Administrator (Admin-A) and the Director of Nursing (DON#1) during an interview on 6/9/21 at 4:50 PM. Admin-A stated, "We'll make sure to document much better going forward."

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse conducted the initial assessment visit within 48 hours of referral, and determine the immediate care needs of the patient for 2 of 7 (MR's #1 and 2) records reviewed (See G514); failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 3 of 7 (MR's #1, 3, and 4) records reviewed (See G528); and failed to ensure a registered nurse notified the physician after conducting a review of the patient's medications for any major drug interactions in 1 of 7 (MR# 5) records reviewed, and failed to update the patient's medication profile for 1 of 7 (MR# 4) records reviewed (See G536). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.55, Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse conducted the initial assessment visit within 48 hours of referral, and determine the immediate care needs of the patient for 2 of 7 (MR's #1 and 2) records reviewed in which Skilled Nursing services were ordered, resulting in a delay in needed care and services which has the potential to negatively affect the health and well-being of these patients. Findings include: Agency Policy: "Initial Assessment/Comprehensive Assessments" 9.6.1 (revised January 2020) stated, "A RN, PT or SLP must conduct the initial assessment visit within 48 hours of referral, within 48 hours of the patient's return home or on the physician-ordered start of care date." MR#1: During record review on 6/9/21, the referral for home care services came from a rehabilitation facility dated 4/6/21 for skilled nursing, physical therapy, occupational therapy, social work, and home health aide services. On 4/14/21, skilled nursing (RN#1) documented the start of care (SOC) assessment visit, which was 8 days after the agency received the referral. There was no documentation in the medical record to indicate why the SOC was delayed. On 6/9/2021 at 4:35 PM, the patient was called for an interview to ascertain the extent of services furnished by the Home Health Agency (HHA). During the interview, it was discovered the patient was "pretty upset" at having to call the HHA on 4/13/21 to inquire why services had not yet started. These findings were reviewed with and acknowledged by the Administrator (Admin-A) and the Director of Nursing (DON#1) during an interview on 6/9/21 at 4:50 PM. DON#1 stated, "The intake coordinator is on vacation right now, the ball was dropped. We'll make sure it doesn't happen again." MR#2: The patient was admitted on 5/29/21 with diagnoses of Parkinson's disease, diabetes-type 2, and hypertension. The referral for home care services came from visiting physicians was dated 5/26/21. The referral ordered skilled nursing, physical therapy, and occupational therapy services. On 5/29/21, skilled nursing (RN#1) documented the SOC assessment visit, a day late with no documentation explaining why there was a delay in services. This finding was reviewed with and acknowledged by Admin-A and DON#1 during an interview on 6/10/21 at 10:11 AM. The facility failed to ensure the initial assessment occurred within 48 hours as stipulated by Agency policy.

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: MR#3: The Start of Care (SOC) was dated 5/25/21. The Plan of Care (POC) identified diagnoses of Hypertension and Osteoarthritis. During record review on 6/9/21, it was noted that the SOC comprehensive assessment dated 5/25/21, documented under "Primary Diagnosis and Other Diagnoses", all 13 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#4: The Start of Care (SOC) was dated 5/8/21. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2, and Cellulitis. During record review on 6/8/21, it was noted that the SOC comprehensive assessment dated 5/8/21, documented under "Primary Diagnosis and Other Diagnoses", all 16 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. The DON#1 was questioned on 6/10/21 at 10:55 am and confirmed the findings stating, "Yes, there are no dates of onset or exacerbation. We need to work on that." Based on document review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 6 of 7 (MR's #1, 3, and 4) records reviewed, resulting in incomplete clinical information to aid in determining the needs of this patient and for measuring the patient's progress toward goals/outcomes. Findings include: Agency Policy: "Initial Assessment/Comprehensive Assessments" 9.6.1 (revised January 2020) stated, "The Initial Comprehensive Assessment also includes: Relevant diagnoses and current health status, including all active health and medical problems... Relevant medical history... Drug allergies... Emergent care." MR#1: This patient was admitted to the agency on 4/14/2021 after being discharged from a rehabilitation center on 4/6/21, with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. During record review on 6/9/21, it was noted that the start of care comprehensive assessment completed by RN#1 on 4/14/21, documented no dates of onset, prior treatments, outcomes, or history of how these diagnoses (14 total listed) led to the need for home care. When reviewing the emergency plan for the patient, the documentation was void of any risk factors or contingency plans in the event of an emergency. In addition to the 14 listed diagnoses, skilled nursing documented under "Respiratory Status" for the patient, a history of pneumonia and respiratory failure. No further information, precautions, or potential interventions were identified within the comprehensive assessment regarding this finding. However, when reviewing the referral for the patient, further pertinent information was found which noted a recent hospitalization on 3/16/21 through 3/20/21, which documented the following: "Patient with acute respiratory failure requiring intubation... Respiratory failure thought to be due to aspiration pneumonia." The referral also noted the patient was evaluated by Speech Language Pathology (SLP) on 4/6/21, which documented the patient's need for a mechanical soft diet along with thickened liquids to help prevent the reoccurrence of aspiration pneumonia/respiratory failure. The Agency failed to ensure RN#1's comprehensive assessment included vital information needed to address the patient's current health care needs. These findings were reviewed with and acknowledged by the Administrator (Admin-A) and the Director of Nursing (DON#1) during an interview on 6/9/21 at 4:40 PM. Admin-A stated, "I agree the information on the referral needs to be included on the assessment. So, more details explaining why the need for home care, with the severity of the diagnoses are needed. Ok, we'll get it done."

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: MR#4: The Start of Care (SOC) was dated 5/8/21. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2, and Cellulitis. During record review on 6/8/21, it was noted that the Medication Profile contained Insulin Aspart 100 Units/ML subcutaneous solution 15 units daily subcutaneous. On 5/10/21, the Skilled Nurse documented under the Care Coordination section, "Care coordinated with: SN. Name/Title: RN#1. Regarding: Patient is no longer taking insulin and has oxygen 2-3 lpm (liters per minute) PRN (as needed). The agency failed to update the patients Medication Profile to reflect the current medication changes. The DON#1 was questioned on 6/10/21 at 10:50 am and confirmed the findings stating, "The nurse should have updated the medication profile." Based on record review and interview, the agency failed to ensure a registered nurse notified the physician after conducting a review of the patient's medications for any major drug interactions, for 1 of 7 (MR# 5) records reviewed and failed to update the patient's medication profile for 1 of 7 (MR# 4) records reviewed. This deficient practice results in the potential for the physician not being aware of drug interactions that could negatively affect all 49 current patients. Findings include: **Agency policy "Medication Profile" (no date) stated, "The comprehensive assessment (OASIS) performed at time of admission includes a review of all medication that 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, duplicative drug therapy and noncompliance with drug therapy." MR#5: This patient was admitted to the agency on 4/2/21 with diagnoses of osteoarthritis, hypertension, and chronic obstructive pulmonary disease. The start of care assessment dated 4/2/21performed by registered nurse (RN-B) failed to document a drug-drug interaction. The drug-drug interaction was completed in the patient's electronic record on 6/10/21, resulting a major interaction between Albuterol and Carvedilol. There was no evidence that the physician was notified and ordered the drugs to be continued. During an interview on 6/10/21 at 1200 hours, Admin-A (administrator) stated, "The nurse should have notified the physician of the major interaction found in the drug review."

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 document review and interview, the agency failed to ensure the plan of care included all pertinent diagnoses, patient-specific safety measures, allergies, parameters, and interventions for 3 of 7 (MR# 1, 4 and 7) records reviewed (G 575); failed to ensure services were provided only as ordered by the physician in 4 of 7 (MR's #1, 5, 6, and 7) records reviewed (G580); and failed to coordinate the delivery of skilled nursing (SN), physical therapy (PT), occupational therapy (OT), and medical social work (MSW) services for 4 of 7 (MR#1, 5, 6, and 7) records reviewed in which more than one discipline was ordered to provide care (G 608). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 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 document review and interview, the agency failed to ensure the plan of care included all pertinent diagnoses, patient-specific safety measures, allergies, parameters, and interventions for 3 of 7 (MR# 1, 4 and 7) records reviewed, resulting in the patient not receiving care based on specific individual needs and the potential for a poor patient outcome. Findings include: Agency Policy: "Care Planning Process" 9.9.1 (Revised March 2018) stated, "In order to assure that care provided is appropriately planned to meet each patient's specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process." MR#1: This patient was admitted to the agency on 4/14/2021 with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. The referral for home care services came from a rehabilitation facility on 4/6/21 with orders for the following disciplines: Skilled Nursing, Physical Therapy, Occupational Therapy, Social Work, and Home Health Aide services. The referral noted on page 25 of 26 the following documentation: "Patient with acute respiratory failure requiring intubation... Respiratory failure thought to be due to aspiration pneumonia." The patient was evaluated by Speech Language Pathology (SLP) on 4/6/21 (day of discharge from rehab) with mechanical soft diet along with thickened liquids for precautions. During record review on 6/9/21, the Plan of Care (POC) failed to include the SLP precautions noted to help prevent the reoccurrence of aspiration pneumonia/respiratory failure. These findings were reviewed with and acknowledged by the Administrator, Director of Nursing (DON#1), and Skilled Nursing during an interview on 6/9/21 at 4:55 PM. When queried why the POC had no aspiration precautions, DON#1 replied, "See, I knew that would be found. We'll make sure the information on the referral is reviewed more carefully, these types of precautions can't be missed." MR#4: The Start of Care (SOC) was dated 5/8/21. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2, and Cellulitis. The POC dated 5/8/21 stated, "Allergies: Sinus Allergies." The referral dated 5/7/21 documented the following allergies: Morphine and Motrin. The agency failed to document and accurately assess the patient's allergies. Additionally, the POC failed to have reportable weight parameters. During the entrance interview on 6/8/21 at 10:00 am, the DON#1 stated, "All CHF patients will have reportable parameters on the POC of 2lb weight gain in one day or 5lb weight gain over a week." The DON#1 was questioned on 6/10/21 at 10:50 am and confirmed the findings stating, "The allergies are incorrect. There should be weight parameters on the POC." MR#7: This patient was admitted to the agency on 4/15/21 with diagnoses of end stage kidney disease, heart failure, type 2 diabetes mellitus and atrial fibrillation. The plan of care dated 4/15/21 ordered skilled nursing, physical therapy, home health aide, and masters of social worker (MSW) for evaluation. The physician order dated 4/16/21 specified, "Patient requires MSW for chore provider, SN (skilled nurse) to add MSW services on the case. MD office/office staff notified." During clinical record review on 6/8/21 there was no documented evidence the MSW (medical social worker) completed an evaluation and plan of care for this patient. The MSW documented a missed visit note on 4/20/21 stating, "Patient unable to answer door...Traveled to make visit. Patient unable o (?) buzz LMSW into the building. Several conversations with related family members surrounding long term care options [sic]." There was no evidence the MSW services were provided to the patient as ordered in the plan of care. During an interview on 6/10/21 at 1130 hours, Admin-A (administrator) stated, "The MSW failed to evaluate the patient, I am not sure what happened."

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 document review and interview, the agency failed to ensure services were provided only as ordered by the physician in 4 of 7 (MR's #1, 5, 6, and 7) records reviewed, resulting in the potential to negatively affect this patient. Findings include: Agency Policy: "Physician Orders-Verbal Orders" 11.9.1 (Revised March 2018) stated, "Drugs and treatments are administered by the Agency staff only as ordered by the physician." MR#5: This patient was admitted to the agency on 4/2/21 with diagnoses of osteoarthritis, hypertension, and chronic obstructive pulmonary disease. The plan of care dated 4/2/21 orders the skilled nurse to provide a visit frequency of one visit week 1, 2 visits week 2 and 3 and physical therapy to evaluate and treat the patient. Clinical record review on 6/8/21 (over 60 days since start of care) indicates there was no signed physician plan of care, verifying that the physician had ordered the services the agency was providing to this patient. Additionally, the physical therapist failed to document in the clinical record an evaluation and plan of care for this patient after the 4/2/21 start of care assessment by the registered nurse. In week 6 the physical therapist started providing visits on 5/5/21 and re-evaluation on 5/7/21. There was no evidence found in the clinical record that the physical therapist performed an evaluation and developed a plan of care after communicating with the physician the evaluation findings. The physical therapist failed to have physician orders prior to providing therapy services to this patient. MR#6: This patient was admitted to the agency on 5/17/21 with diagnoses of osteoarthritis, type 2 diabetes mellitus, and chronic obstructive pulmonary disease. The plan of care dated 5/17/21 orders the registered nurse visit frequency and physical therapist to evaluate and treat the patient. The physical therapist evaluated the patient on 5/28/21, there was no evidence the physical therapist contacted the physician regarding the evaluation findings and received input from the physician in developing the plan of care for therapy for this patient. MR#7: This patient was admitted to the agency on 4/15/21 with diagnoses of end stage kidney disease, heart failure, type 2 diabetes mellitus and atrial fibrillation. The plan of care dated 4/15/21 orders the skilled nurse to provide one visit week 1 (initial start of care assessment on 4/15/21), 2 visits week 2, and weekly visits for the next 3 weeks, and physical therapy to evaluate and treat the patient. Clinical record review on 6/8/21(50 plus days since start of care) indicates there was no physician signed plan of care, verifying that the physician had ordered the services the agency was providing to this patient. Additionally, for this patient the physical therapist failed to document a time, date, and person talked to at the physician office after the delayed 4/27/21 patient evaluation. There was no evidence documented that the physician had contributed to the physical therapy plan of care. The above findings were reviewed and acknowledged by Admin-A (administrator) and CM-1 (clinical manager) during an interview on 6/10/21 at 1200 hours. MR#1: This patient was admitted to the agency on 4/14/2021 with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. During record review on 6/9/21, the plan of care (POC) dated 4/14/21 ordered the following disciplines/frequencies: SN-1wk1wk (once a week times one week), 2wk1wk, 1wk2wk, PT-eval. and treat, OT-eval. and treat, and MSW-evaluate. Record review noted PT services performed an initial evaluation dated 4/27/21, 13 days after the start of care. Further review noted SN provided no further visits after the initial start of care assessment on 4/14/21. Additionally, no documentation was found in the clinical record for OT and MSW services. No documentation of patient refusal or physician notification was evidenced concerning the lack of services furnished as ordered. These findings were reviewed with and acknowledged by the Administrator, Director of Nursing, and Skilled Nursing (RN#1) during an interview on 6/9/21 at 4:55 PM. When queried why there was a delay or no services provided as ordered, RN#1 stated, "It's absolutely my fault, I was supposed to coordinate with the LPN (Licensed Practical Nurse), and I didn't follow-up. I didn't coordinate with any of the other services either." The facility failed to ensure that all services were provided as ordered as stipulated by Agency policy.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: MR#5: This patient was admitted to the agency on 4/2/21 with diagnoses of osteoarthritis, hypertension, and chronic obstructive pulmonary disease. The plan of care dated 4/2/21 orders the skilled nurse to provide one visit week 1, 2 visits week 2 and 3 and physical therapy to evaluate and treat the patient. Clinical record review on 6/8/21 indicates there was no documented evidence that the RN-1 (registered nurse) provided visits in week 2 (4/4/21-4/10/21) and week 3 (4/11/21-4/17/21). There was no documentation that the nurse attempted to make a visit or reason for missing the visits. There was no evidence RN-1 was the case manager and documented coordination of the patient's services. Additionally, for this patient the physical therapist failed to document in the clinical record an evaluation and plan of care for this patient after the 4/2/21 start of care assessment by the registered nurse. In week 6 the physical therapist started providing visits on 5/5/21 and re-evaluation on 5/7/21. No documentation of patient refusal or physician notification was evidenced concerning the lack of therapy services furnished. There was no evidence the physical therapist communicated with the case manager RN-1 regarding the reason he failed to provide services to the patient until week 6. MR#6: This patient was admitted to the agency on 5/17/21 with diagnoses of osteoarthritis, type 2 diabetes mellitus, and chronic obstructive pulmonary disease. The plan of care dated 5/17/21 orders the registered nurse with a frequency of 2W1, 1W3 and the physical therapist to evaluate and treat the patient. The physical therapist failed to evaluate the patient until 5/28/21, eleven days after the initial comprehensive assessment by the registered nurse. There was no reason documented in the clinical record for the delay and no physician approval. There failed to be communication documented to RN#1, the case manager regarding the delay in the therapy evaluation. MR#7: This patient was admitted to the agency on 4/15/21 with diagnoses of end stage kidney disease, heart failure, type 2 diabetes mellitus and atrial fibrillation. The plan of care dated 4/15/21 orders the skilled nurse to provide one visit week 1 (initial start of care assessment on 4/15/21), 2 visits week 2, and weekly visits for the next 3 weeks, physical therapy to evaluate and treat, and MSW (master of social worker) was to evaluate. Clinical record review on 6/8/21 indicates there was no documented evidence the nurse provided 2 visits in week 2 (4/18/21-4/24/21-one nurse visit provided on 4/20/21), no evidence of the skilled nurse visits for weeks 3, 4, 5. There was no documentation that the nurse attempted to make a visit or reason for missing the visits. The registered nurse failed to coordinate the patient care as the case manager. Additionally, for this patient the MSW (medical social worker) failed to document in the clinical record an evaluation and plan of care for this patient after the 4/15/21 start of care assessment by the registered nurse. There was no evidence that the MSW services were provided to the patient as ordered. There was no evidence that the MSW communicated and coordinated patient services with the RN-1, the case manager. During an interview on 6/10/21 at 1130 hours, Admin-A (administrator) stated, "The staff are not coordinating the patient services and there has been no oversight by the case manager." Based on record review and interview, the Agency failed to coordinate the delivery of skilled nursing (SN), physical therapy (PT), occupational therapy (OT), and medical social work (MSW) services for 4 of 7 (MR#1, 5, 6, and 7) records reviewed in which more than one discipline was ordered to provide care. This practice resulted in the potential for unmet personal care needs for this patient and the potential for decline in physical functioning. Findings include: MR#1: This patient was admitted to the agency on 4/14/2021 with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. During record review on 6/9/21, the plan of care (POC) dated 4/14/21 ordered the following disciplines/frequencies: SN-1wk1wk (once a week times one week), 2wk1wk, 1wk2wk, PT-eval. and treat, OT-eval. and treat, and MSW-evaluate. Record review noted PT services performed an initial evaluation dated 4/27/21, 13 days after the start of care. Further review noted SN provided no further visits after the initial start of care assessment on 4/14/21. Additionally, no documentation was found in the clinical record for OT and MSW services. No documentation of patient refusal or physician notification was evidenced concerning the lack of services furnished. These findings were reviewed with and acknowledged by the Administrator, Clinical Manager, and Skilled Nursing (RN#1) during an interview on 6/9/21 at 4:55 PM. When queried why there was a delay or no services provided as ordered, RN#1 stated, "It's absolutely my fault, I was supposed to coordinate with the LPN (Licensed Practical Nurse), and I didn't follow-up. I didn't coordinate with any of the other services either." The facility failed to ensure that SN had coordinated the timely provision of skilled nursing, physical therapy, occupational therapy, and social work services as ordered.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on policy review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (refer to G-642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (refer to G-644); failed to document the quality improvement projects for 2018, 2019, and 2020 and document the reasons for conducting these projects and the measurable progress achieved each year (Refer to G-658); and failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section (refer to G-660). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency serves for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 256 patients that were admitted during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The agency's Quality Assessment and Performance Improvement (QAPI) documentation was reviewed on 6/9/21. There was no documentation to support the agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained documentation and instructions for a QAPI program, but had no additional data added, thus unable to quantitively demonstrate improvements. The DON#1 was questioned regarding QAPI indicators and process to measure on 6/10/21 at 9:45 am and stated, "We have downloaded all of our CMS CASPER reports, but we have not yet tabulated to show measurable improvements." The agency failed to ensure their QAPI program was at least capable of showing measurable improvements in indicators to improve patient outcomes, safety and quality of care.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the quality assessment and performance improvement program, which had the potential to negatively affect all patients serviced by the agency, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: During an interview on 6/9/2021 at 11 am a request was submitted to review the QAPI (quality assessment performance improvement) documents for 2018, 2019, 2020 and 2021. The DON#1 was unable to produce the documents for 2018, 2019, and 2020. The DON#1 did provide an undated "Infection Control Quality Assurance & performance Improvement (QAPI) Case Study." The case study stated, "Serenity Home Health Care, LLC is a local Home Care Provider in Southfield MI. While reviewing the quarterly CASPER report, the team noticed that the infection quality measure was high at 15.5 percent as compared to the state (.7 percent) and national (4.9 percent) averages. The team decided to look into all residents listed as having had infections and numerous residents had experiences repeated in the last three months." The requested infection report had zero patient infections reported from 1/31/20 to 5/30/21. The DON#1 was questioned regarding the wrong documentation and stated, "I am not sure where we came up with those infection numbers."

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2019 and 2020 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: On 6/9/21 at 2:20 pm during an interview, the DON#1 was queried about documentation of the Agency's QAPI (Quality Assessment Performance Improvement) program and Performance Improvement Projects, reasons for conducting the projects along with measurable progress achieved. DON#1 was unable to provide the requested data and stated, "We only just started this one improvement project since we started here."

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based record review and interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 49 patients currently receiving services and all 256 patients admitted over the past year. Findings include: During an interview on 6/9/21 at 2:20 p.m., a request was made to review the agency's Quality Assessment Performance Improvement (QAPI) report and Governing Body meeting minutes for 2019, 2020 and 2021. Upon receipt and review of the agency's QAPI data, there was no data made available for review that determined or affirmed the Governing Body's oversight of the QAPI program for the years 2019 and 2021. These findings were reviewed with and acknowledged by DON#1 on 6/10/21 at 9:55 am.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on document review and interview, it was determined that the Agency failed to ensure that skilled nursing services, physical therapy services, and medical social worker services were provided at the frequency ordered by the physician for 6 of 7 (MR's #1, 3, 4, 5, 6, and 7) records reviewed (see G710); and failed to ensure skilled professionals prepared clinical notes for 6 of 7 (MR's# 1, 3, 4, 5, 6, and 7) records reviewed, (see G716). The cumulative effect of these systemic failures resulted in a hospitalization for unidentified patient needs; the possibility for decline in physical functioning and unmet care needs; and the physician not having a complete clinical picture of the patient's health status during the period of care.

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: MR#1: This patient was admitted to the agency on 4/14/2021 with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. During record review on 6/9/21, the plan of care (POC) dated 4/14/21 ordered the following disciplines/frequencies: SN-1wk1wk (once a week times one week), 2wk1wk, 1wk2wk, PT-eval. and treat, OT-eval. and treat, and MSW-evaluate. Record review noted PT services performed an initial evaluation dated 4/27/21, 13 days after the start of care. Further review noted SN provided no further visits after the initial start of care assessment on 4/14/21. Additionally, no documentation was found in the clinical record for OT and MSW services. No documentation of patient refusal or physician notification was evidenced concerning the lack of services furnished as ordered in the POC. Additionally, no documentation was noted of any efforts made to reschedule the missed visits to be in compliance with the POC visit frequencies. These findings were reviewed with and acknowledged by the Administrator, Director of Nursing, and Skilled Nursing (RN#1) during an interview on 6/9/21 at 4:55 PM. When queried why the POC was not implemented as directed, RN#1 stated, "It's absolutely my fault, I was supposed to coordinate with the LPN (Licensed Practical Nurse), and I didn't follow-up. I didn't coordinate with any of the other services either." The facility failed to ensure that all services were provided as ordered as stipulated by Agency policy. MR#3: The Start of Care (SOC) was dated 5/25/21. The Plan of Care (POC) identified diagnoses of Hypertension and Osteoarthritis. During record review on 6/9/21, it was noted that the POC dated 5/25/21 ordered "Physical Therapy (PT): Evaluate and Treat" and "Occupational Therapy (OT): Evaluate and Treat." The PT evaluation dated 6/3/21 was late by 9 days from the Skilled Nurse (SN) Comprehensive Assessment dated 5/25/21. Additionally, the OT evaluation completed on 6/3/21 was also 9 days late. During the entrance interview on 6/8/21 at 10:00 am, when questioned on the timeframe for additional services to evaluate the patient, the DON#1 stated, "Within 48 hours." The agency failed to evaluate the patient within 48 hours. MR#4: The Start of Care (SOC) was dated 5/8/21. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2, and Cellulitis. During record review on 6/8/21, it was noted that the POC dated 5/8/21 ordered "Physical Therapy: Evaluate and Treat." The PT evaluation dated 5/18/21 was late by 10 days from the SN Comprehensive Assessment dated 5/8/21. The agency failed to evaluate the patient within 48 hours. The DON#1 was questioned on 6/10/21 at 10:40 am and confirmed the findings stating, "The evaluations are late. Yes, they are not turning in their documentation on time." Based on record review and interview, the agency failed to ensure that skilled nursing services, physical therapy services, and medical social worker services were provided at the frequency ordered by the physician for 6 of 7 (MR's #1, 3, 4, 5, 6, and 7) records reviewed in which all the above services were ordered, resulting in the potential for poor patient outcomes for these patients. Findings include: **Agency policy "Skilled Professional Services" (no date) stated, "Patients receiving skilled professional services will receive appropriate assessments, reassessments, care planning, established outcomes and care per physician orders." MR#5: This patient was admitted to the agency on 4/2/21 with diagnoses of osteoarthritis, hypertension, and chronic obstructive pulmonary disease. The plan of care dated 4/2/21 orders the skilled nurse to provide one visit week 1, 2 visits week 2 and 3 and physical therapy was to evaluate and treat the patient. Clinical record review on 6/8/21 indicates there was no documented evidence that the nurse provided visits in week 2 (4/4/21-4/10/21) and week 3 (4/11/21-4/17/21) as ordered by the physician. There was no documentation that the nurse attempted to make a visit or reason for missing the visits. The registered nurse failed to provide the visit frequency as ordered by the physician. Additionally, for this patient the physical therapist failed to document in the clinical record an evaluation and plan of care for this patient after the 4/2/21 start of care assessment by the registered nurse. In week 6 the physical therapist started providing visits on 5/5/21 and re-evaluation on 5/7/21. There was no evidence found in the clinical record that the physical therapist provided services as ordered in the plan of care. MR#6: This patient was admitted to the agency on 5/17/21 with diagnoses of osteoarthritis, type 2 diabetes mellitus, and chronic obstructive pulmonary disease. The plan of care dated 5/17/21 orders the registered nurse and physical therapist to evaluate and treat the patient. The physical therapist failed to evaluate the patient until 5/28/21, eleven days after the initial comprehensive assessment by the registered nurse. There was no reason documented in the clinical record for the delay and no physician approval for the delay. During a joint Medicare home visit on 6/9/21 at 1100 hours with the registered nurse, when the patient and caregiver were asked if they requested a delay in physical therapy services, they denied any request for the delay. MR#7: This patient was admitted to the agency on 4/15/21 with diagnoses of end stage kidney disease, heart failure, type 2 diabetes mellitus and atrial fibrillation. The plan of care dated 4/15/21 orders the skilled nurse to provide one visit week 1 (initial start of care assessment on 4/15/21), 2 visits week 2, and weekly visits for the next 3 weeks, and physical therapy was to evaluate and treat the patient. Clinical record review on 6/8/21 indicates there was no documented evidence the nurse provided 2 visits in week 2 (4/18/21-4/24/21-one nurse visit provided on 4/20/21), no evidence of the skilled nurse visits for weeks 3, 4, 5 as ordered by the physician. There was no documentation that the nurse attempted to make a visit or reason for missing the visits. The registered nurse failed to provide the visit frequency as ordered by the physician. Additionally, for this patient the MSW (medical social worker) failed to document in the clinical record an evaluation and plan of care for this patient after the 4/15/21 start of care assessment by the registered nurse. The physician order dated 4/16/21 specified, "Patient requires MSW for chore provider, SN (skilled nurse) to add MSW services on the case. MD office/office staff notified." The MSW documented a missed visit note on 4/20/21 stating, "Patient unable to answer door...Traveled to make visit. Patient unable o (?) buzz LMSW into the building. Several conversations with related family members surrounding long term care options [sic]." There was no evidence that the MSW services were provided to the patient as ordered by the physician. During an interview on 6/10/21 at 1130 hours, Admin-A (administrator) stated, "The staff are not following the physician orders by providing the service frequency as ordered."

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals prepared clinical notes for 6 of 7 (MR's# 1, 3, 4, 5, 6, and 7), records reviewed, resulting in the physician not having a complete clinical picture of the patient's health status and progress toward goals during the period of care. Findings include: **Agency policy "Medical Record Content" (no date) stated, "The Agency will provide an accurate and current medical record for every patient seen by the Agency." MR#5: This patient was admitted to the agency on 4/2/21 with diagnoses of osteoarthritis, hypertension, and chronic obstructive pulmonary disease. The plan of care dated 4/2/21 orders the skilled nurse to provide one visit week 1, 2 visits a week for weeks 2 and 3 and physical therapy was to evaluate and treat the patient. The registered nurse completed the initial comprehensive assessment on 4/2/21. Clinical record review on 6/8/21 indicates there was no documented evidence that the nurse provided any additional visits after the 4/2/21 initial assessment. There was no documentation to indicate that the patient had been discharged or declined SN (skilled nursing) services. Admin-A (administrator) reviewed the clinical record on 6/10/21 at 1130 hours and stated, "The nurse failed to document the visits and visit notes in the clinical record." Additionally, for this patient the physical therapist failed to document in the clinical record an evaluation and a therapy plan of care for this patient after the 4/2/21 start of care assessment by the registered nurse. In week 6 the physical therapist started providing visits on 5/5/21 and re-evaluation on 5/7/21 with a plan of care starting 4/9/21 with a frequency of 1W1, 2W6. There was no evidence found in the clinical record that the patient had been discharged or declined PT (physical therapy) services. The PT failed to document visits in the clinical record. MR#6: This patient was admitted to the agency on 5/17/21 with diagnoses of osteoarthritis, type 2 diabetes mellitus, and chronic obstructive pulmonary disease. The plan of care dated 5/17/21 orders the registered nurse frequency 2W1, 1W3 and physical therapist to evaluate and treat the patient. The physical therapist failed to document visits notes for week 3 (5/30/21-6/5/21), which during an entrance interview on 6/8/21 at 1000 hours Admin-A stated, "The visit notes for last week are due by Tuesday 6/8/21. MR#7: This patient was admitted to the agency on 4/15/21 with diagnoses of end stage kidney disease, heart failure, type 2 diabetes mellitus and atrial fibrillation. The plan of care dated 4/15/21 orders the skilled nurse to provide visit frequency of 1W1 (initial start of care assessment on 4/15/21), 2W1 and 1W3, and physical therapy to evaluate and treat the patient. Clinical record review on 6/8/21 indicates there was no documented evidence that the nurse provided any additional visits after the 4/15/21 initial assessment and 4/20/21 visit note. There was no documentation to indicate that the patient had been discharged or declined SN (skilled nursing) services. Admin-A (administrator) reviewed the clinical record on 6/10/21 at 1130 hours and stated, "The nurse failed to document the visit notes in the clinical record." Additionally, for this patient the MSW (medical social worker) failed to document in the clinical record an evaluation and plan of care for this patient after the 4/15/21 start of care assessment by the registered nurse. The physician order dated 4/16/21 specified, "Patient requires MSW for chore provider, SN (skilled nurse) to add MSW services on the case. MD office/office staff notified." The MSW documented a missed visit note on 4/20/21 stating, "Patient unable to answer door...Traveled to make visit. Patient unable o (?) buzz LMSW into the building. Several conversations with related family members surrounding long term care options [sic]." There was no evidence that the MSW services were provided to the patient or had been declined. The MSW failed to document clinical and visit notes in the patient's record. During an interview on 6/10/21 at 1130 hours, Admin-A (administrator) stated, "The staff are not doing or documenting the patient visits." MR#1: This patient was admitted to the agency on 4/14/2021 with diagnoses which included hypertensive heart disease with heart failure, diabetes-type 2, and Parkinson's disease. During record review on 6/9/21, the Plan of Care (POC) dated 4/14/21 ordered the following disciplines/frequencies: SN (Skilled Nursing)-1wk1wk (once a week times one week), 2wk1wk, 1wk2wk, PT (Physical Therapy)-eval. and treat, OT (Occupational Therapy)-eval. and treat, and MSW (Master of Social Work)-evaluate. Record review noted physical therapy (PT) services performed an initial evaluation with corresponding POC on 4/27/21. The POC for PT documented a visit frequency of twice a week times five weeks, followed by once a week for one week. When the PT visit notes/re-evaluation (10 of 10 entries dated 4/29/21 through 6/1/21) were reviewed, all clinical notes were void of any treatment interventions, assessments, clinical narrative, or treatment plans/goals. Further review noted no clinical entries were made by SN after the initial start of care assessment on 4/14/21. Additionally, no clinical notes were found concerning OT and MSW services. No documentation was found which explained why MR#1 was significantly incomplete. These findings were reviewed with and acknowledged by the Administrator (Admin-A), and the Director of Nursing during an interview on 6/9/21 at 4:55 PM. Admin-A reaffirmed that clinical notes are due every Tuesday on a weekly basis and that staff were not turning in their documentation on time. MR#3: The Start of Care (SOC) was dated 5/25/21. The Plan of Care (POC) identified diagnoses of Hypertension and Osteoarthritis. During record review on 6/9/21, it was noted that the POC dated 5/25/21 ordered "Physical Therapy (PT): Evaluate and Treat." The PT evaluation dated 6/3/21 was blank and contained no documentation. During the entrance interview on 6/8/21 at 10:00 am, when questioned on the timeframe for completing documentation, the DON#1 stated, "By every Tuesday for the prior week's visits." The agency failed to complete visit notes timely. MR#4: The Start of Care (SOC) was dated 5/8/21. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure (CHF), Diabetes Type 2, and Cellulitis. During record review on 6/8/21, it was noted that the POC dated 5/8/21 ordered "Physical Therapy: Evaluate and Treat." The PT evaluation dated 5/18/21was blank and contained no documentation. The Skilled Nursing (SN) discharge was dated for 5/31/21. The discharge visit note was blank and contained no documentation. The record was checked again on 6/10/21 and the discharge visit remained blank. The agency failed to complete visit notes timely. The DON#1 was questioned on 6/10/21 at 10:40 am and confirmed the findings stating, "Yes, the PT did evaluate those patients even though the visit note is blank. They are not turning in their documentation on time. I am not sure if the nurse has completed the discharge or not."

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 2 of 3 records reviewed (MR 5 and 7) with home health aide services, for a potential of unmet and unsafe patient care. Findings include: Agency policy "Home Health Aide Supervision" (no date) stated, "All home health aide supervisory visits will be made at least every 14 days." MR#5: This patient was admitted to the agency on 4/2/21 with diagnoses of osteoarthritis, hypertension, and chronic obstructive pulmonary disease. The plan of care dated 4/2/21 ordered skilled nursing, physical therapy, and home health aide services. The Home Health Aide (HHa) completed 8 visits on 4/13/21, 4/15/21, 4/21/21, 4/24/21, 4/27/21, 5/1/21, 5/3/21, and 5/8/21. There was no documented evidence the RN completed a supervisory visit from 4/13/21 to 5/8/21, no less frequently than every 14 days, to supervise the home health aide services. MR#7: This patient was admitted to the agency on 4/15/21 with diagnoses of end stage kidney disease, heart failure, type 2 diabetes mellitus and atrial fibrillation. The plan of care dated 4/15/21 orders skilled nursing, physical therapy, and home health aide services. The Home Health Aide (HHa) completed 4 visits on 4/23/21, 4/26/21, 5/1/21 and 5/3/21 and missed visits on 4/21/21, and 5/7/21. There was no evidence the RN completed a supervisory visit from 4/21/21 to 5/7/21, no less frequently than every 14 days, to supervise the home health aide services. The CM#1 (clinical manager) was questioned on 6/10/21 at 1200 hours and confirmed the findings stating, "I do not see documentation of the aide supervision notes."

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the Home Health Agency failed to ensure the Governing Body assumed full legal authority and responsibility for the agency's overall management and daily operations (See G942) and failed to ensure that at least one qualifying service was provided directly by agency employees (See G982). The cumulative effect of these systemic problems resulted in the home health agency's inability to assure that the administrative and clinical supervisory functions were not delegated to another agency or organization and ensure the provision of quality health care for the Condition of Participation of 42 CFR484.105, Organization and Administration of Services.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: On 6/10/2021 at 11:25 AM, it was discovered the Administrator (Admin-A) and Director of Nursing (DON#1) represented a contracted agency (D&D Consulting LLC) hired on 5/3/21 to perform administrative and supervisory functions for the Agency. Adm-A stated, "We come in and help agencies that are struggling, get them running smoothly and then they hire a regular administrator and clinic manager. When queried if it's one agency at a time, CM#1 replied, "We usually do two at a time, but no more than three." When it was brought to their attention the Agency's Governing Body was in violation of the Conditions of Participation by contracting out administrative and supervisory functions, Admin-A stated, "We didn't know that. This is the first time it's come up. We'll have to change on how we do our business then." The Governing Body failed to ensure the Agency's daily operation plan concerning administrative and supervisory functions were not delegated to another organization. Based on document review and interview, it was determined the home health agency failed to have an active Governing Body that met at least annually, ensured administrative and supervisory functions were not delegated to another organization, assumed full legal authority and responsibility for the agency's overall management and operations, all services provided, the fiscal operations, and review of the agency's budget and operations plans, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: **Agency policy "Governing Body" (no date) stated, "The Governing Body (or designated person so functioning) assumes full legal authority and responsibility for the Agency's overall management and operation, the provision of all home health services, fiscal operations, review of the Agency's budget and its operational plans...To ensure appropriate quality services are provided to patients. " On 6/10/21 at 1000 hours, the Governing Body meeting minutes were requested for review. Upon review of the Governing Body meeting minutes, the Admin-A (administrator) was unable to produce any current Governing Body meeting minutes. There was no documented evidence the Governing Body met, at least annually for 2019, 2020 and 2021, was responsible for the overall management and operations of the agency, and developed a budget and operations plan that was reviewed annually. The last Annual meeting of the Governing Body was dated 1/31/2011. Admin-A stated, "We were just hired by the agency on 5/3/21 to come in prepare for the recertification of the agency. Admin-A went on to say, "We are a consulting group, and bring our staff to get the agency in compliance." An organization chart was received dated 5/3/21 stating, "Serenity Home Health Care, LLC, Organization Chart of Governor Body Update [sic] with the CEO name at the top (unknown name), Administrator-Admin-A, and Clinical Manager-CM#1. There was no evidence of a Governing Body participants. On 5/3/21 there was an Emergency meeting documented that stated, "(Name) CEO called emergency meeting to appoint new governing body board members on 5/3/2021. DON (CM#1-clinical manager), Administrator- (Admin-A), DON/Administrator (name). Was approved and granted by (name of CEO). Meeting adjourn at 5:30 PM." Signatures were included for all the above names and dated 5/3/21. Additionally, review of the agency policy book on 6/10/21 stated, "Policies & Procedures Manual for Home Health Care" published by MEDPASS was noted to have another agency name on the signature page stating, "Approval of Home Health Care Policies and Procedures Manual, Mission, Vision, Goal and Strategic Plans" with the OM#1 (Office Manager) signature and dated 3/8/21 (prior to the contracted agency starting at the Serenity Home Health Care Agency). There failed to be evidence that the governing board/administration had signed the policy book. The agency was using a contract agency for administration and there was evidence they were moving their policy book from one agency to another. All these administration and organization deficiencies failed them from ensuring appropriate quality services and care to their patients. During an interview on 6/10/21 at 1200 hours Admin-A and CM#1 acknowledged the above findings. The agency failed to have an active Governing Body that assumes full legal authority and responsibility for the overall management and operation of the home health agency as required by their policy. .

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on interview and record review, the administrator failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for all services to be provided by contracted staff. Findings include: During the entrance conference on 6/8/21, the administrator (ADM#1) was asked what services were currently provided by the agency. The response was, "We offer Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST), Home Health aide (HHa), and Dietician services." When asked what service was provided directly by the agency, ADM#1 stated, "Nursing." ADM#1 was then questioned what services were available through contracts. ADM#1 replied, "All services are available through contract." The agency failed to ensure that at least one qualifying service was provided directly by agency employees.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was sent to the physician within 5 business days of the patient's discharge for 1 of 1 (MR# 5) records reviewed in which the patient was discharged from the agency, resulting in the physician not having knowledge of the patient's health status at the time of discharge and a summary of the care received which has the potential to negatively affect these patients. Findings include: **Agency policy "Discharge Summary" (no date) stated, "A Discharge Summary will be completed for all patients discharged from the Agency...will be sent within 5 business days of patient discharge to the primary care practitioner ..." MR#5: This patient was admitted to the agency on 4/2/21 and a discharge OASIS (outcome and assessment information set) was completed by the physical therapist on 5/7/21. Record review on 6/8/21 indicates there was no documented evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The findings were reviewed with Admin-A (administrator) during an interview on 6/10/21 at 1200 hours, Admin-A acknowledged there was no documentation of the discharge summary being sent to the physician.