Every finding on record at Sympathy Home Health Care, Inc

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Patient Rights was met as follows: Based on interview and record review the Home Health Agency (HHA) failed to provide documented evidence to inform the patient's rights, and responsibilities before furnishing care to the patient for one of five sampled patients (Patient 8). This deficient practice resulted in patient not being able to fully understand his/her rights as a patient receiving home health services. Refer to G412. -The Home Health Agency (HHA) failed to ensure one of five sampled patients (Patient 8) signed consent for HHA services. This failure resulted in patient receiving HHA services without consent. Refer to G418. -The Home Health Agency (HHA) failed to ensure one of five sampled patients (Patient 8) was informed of all aspects of the planned care and services, and the way the care and services will be delivered by the HHA. This failure resulted in the violation of Patient 8's rights to be informed of the care and treatment furnished by the HHA as identified in the plan of care (POC). Refer to G434. -The HHA failed to ensure two of five sample patients (Patient 8, and Patient 11) received Physical Therapy (PT) as ordered in the POC. The deficient practice resulted in both patients not provided PT and not meeting their physical therapy needs. Refer to G436. -The Home Health Agency (HHA) failed to ensure three of five sampled patients (Patient 8, Patient 11, Patient 12) received information regarding the State toll free home health contact information, its hours of operation, and its purpose. This failure resulted in the violation of patient’s rights for not being informed of the toll-free hotline number to lodge their concerns of the care and services provided by the HHA. Refer to G444. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Patient Rights to ensure highest quality health care is provided to patients assessed to receive home health services.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to provide documented evidence to inform the patient's rights, and responsibilities before furnishing care to the patient for one of five sampled patients (Patient 8). This deficient practice resulted in patient not being able to fully understand his/her rights as a patient receiving home health services. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. During an interview on 5/1/2024 at 11:15 a.m. with Patient 8, Patient 8 stated, “I haven’t received anything from this agency. The two nurses LVN 1 and LVN 2 came to the house last night and were telling me that they gave me something, but they never did. I never received a booklet or any paperwork from them.” During an interview on 5/1/2024 at 11:18 a.m. with Patient 8’s daughter, Patient 8’s daughter stated, “they have never given anything to us. I don’t even know what agency these nurses came from. They came to the house last night late around 9 pm but they never gave us any paperwork.” Interview with on 5/2/20204 at 1:42 p.m., with ADM/DPCS, ADM/DPCS stated, “when a patient is admitted to our HHA, the SOC nurse will give then a copy of the consent, the patient rights, POC, form where they document visits, and our folder.” During a record review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, undated, the policy indicated, “1. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: T. The availability of the applicable toll-free home health agency hotline and other sources to receive questions or complaints and assist in resolution including implementation of the advanced directive requirements. V. The contact information for the agency administrator, including the administrator’s name business address, and business phone number in order to receive complaints. 4. The admitting clinician will provide each patient or his/her representative with a written copy of the patient rights and responsibilities on admission. 6. The patient or legal representative will be requested to sign the patient rights and responsibilities form period the original form will be kept in the patient's clinical record period a copy correct will be maintained by the patient period the patient's refusal to sign will be documented in the clinical record including the reason for the refusal.” The policy further indicated, “the patient has the right to: Receive all services in the plan of care.”

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on interview and record review the agency staff failed to ensure one of five sampled patients (Patient 8) signed consent for care for HHA services. This failure resulted in patient receiving HHA services without consent. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. During a concurrent record review and interview on 5/1/2024 at 12 p.m. with Patient 8, of the HHA admission consent form, Patient 8 stated, “that is not my signature. I didn’t sign that. I never signed anything for them.” During a concurrent observation and interview on 5/1/2024 at 12:05 p.m. with Patient 8’s daughter, Patient 8's daughter stated, “that is not my mom’s signature, she never writes her last name first and that is not her writing. Here is her license, this is what her signature looks like.” Patient 8’s driver license observed, signature on Patient 8’s driver’s license different than the one on HHA consent form. During a record review of Patient 8’s Hospital Emergency Department Note, dated 4/20/2024 at 1:06pm, indicated Patient 8's signature. Patient 8's signature did not match the signature on HHA Admission Consent. During an Interview on 5/2/2024 at 1:36 p.m. with ADM/DPCS in conference room of HHA, ADM/DPCS stated, “I have never visited Patient 8. I did not do the SOC or consents for patient 8. It was done by RN 1; I just entered the OASIS for RN 1.” During a record review of Patient 8's HHA Admission consent form, dated 4/6/2024, indicated ADM/DPCS signature for witness/ agency representative.

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 interview and record review the to ensure one of five sampled patients (Patient 8) was informed of all aspects of the planned care and services, and the way the care and services will be delivered by the HHA. This failure resulted in the violation of Patient 8's rights to be informed of the care and treatment furnished by the HHA as identified in the plan of care (POC). During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. During an interview on 5/1/2024 at 11:15 a.m. with Patient 8, Patient 8 stated, “I haven’t received anything from this agency. The two nurses LVN 1 and LVN 2 came to the house last night and were telling me that they gave me something, but they never did. I never received a booklet or any paperwork from them.” During an interview on 5/1/2024 at 11:18 a.m. with Patient 8’s daughter, Patient 8’s daughter stated, “they have never given anything to us. I don’t even know what agency these nurses are from. They came to the house last night late around 9 pm but they never gave us any paperwork.” During an interview on 5/1/2024 at 11:38 a.m. with Patient 8, Patient 8 stated, “when I spoke to you yesterday I didn’t know that LVN 2 was from a home health agency that’s why I said no one is coming. LVN 2 had been to the house a few times before, but I didn’t know where they were from. LVN 2 never explained anything to me when LVN 2 came.” During a phone interview on 5/2/2024 at 10:50 a.m., with Patient 8’s daughter, Patient 8’s daughter stated, “please provide me with the home health agency’s name and phone number since we don’t have anything from them. I want to call and terminate services for my mom even though my mom never signed anything for them to care for her in the first place. After them showing up the other night like that and showing up the next morning to take my mom to the doctors office, my mom is scared. I don’t want them coming to my house.” During an Interview with on 5/2/20204 at 1:42 p.m. with ADM/DPCS, ADM/DPCS stated, “when a patient is admitted to our HHA, the SOC nurse will give then a copy of the consent, the patient rights, POC, form where they document visits, and our folder.” During a record review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, undated, the policy indicated, “1. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: T. The availability of the applicable toll-free home health agency hotline and other sources to receive questions or complaints and assist in resolution including implementation of the advanced directive requirements. V. The contact information for the agency administrator, including the administrator’s name business address, and business phone number in order to receive complaints. 4. The admitting clinician will provide each patient or his/her representative with a written copy of the patient rights and responsibilities on admission. 6. The patient or legal representative will be requested to sign the patient rights and responsibilities form period the original form will be kept in the patient's clinical record period a copy correct will be maintained by the patient period the patient's refusal to sign will be documented in the clinical record including the reason for the refusal.” The policy further indicated, “the patient has the right to: Receive all services in the plan of care.”

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on interview, and record review the HHA failed to ensure two of five sample patients (Patient 8, and Patient 11) received Physical Therapy (PT) as ordered in the POC. The deficient practice resulted in both patients not provided PT and not meeting their physical therapy needs. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. Further review of the POC indicated Physical Therapy to evaluate and follow treatment. During a record review of Patient 8’s POC for the certification period from 4/6/2024 to 6/4/2024, included an order for “Skilled Nurse to report /call attending physician if: 5) any incidence of falls/injury, ER visits and/or any hospitalization occurrence 6) any other significant clinical findings.” The POC further indicated “Physical therapy -eval/assess home safety, ADL, and fall/injury risk, physical therapy to instruct patient on therapeutic exercise regimen for balance, gait training, transfer, mobility skills and use of assistive device for ambulation, safety precautions to prevent fall injury. Physical therapy to notify MD for any critical and significant findings. During a record review of patient 8’s Progress Note from Primary Care Physician’s (PCP) dated 4/17/2024, indicated “Plans/Orders Referrals Refer to: Schedule:4-17-2024 Perform: In-House (STAT- refer pt/ot [physical therapy and occupational therapy] in a nursing home. Please refer to LTC [long term care] facility placement.) Referring MD: refer to pt/ot 3 x week x 8 weeks (3 times a week for 8 weeks). During an interview on 5/1/2024 at 11:40 a.m., with Patient 8, patient 8 stated, “I don't ever remember declining physical therapy. Maybe if it was offered to me after I had my back injection because I was still in pain, but it was never re-offered to me. I've been coming to my doctor's office for the past month and asking to get physical therapy and to go back to the rehab center to get physical therapy because I've been getting weaker, I didn't know that was something that was available for me.” During a record review of Patient 8’s paper chart untitled paper including Patient 8’s name dated 4/12/2024, a handwritten note indicated “orders: Hold PT, patient & family request patient in pain.” Clinician Name/Signature not eligible. During an interview on 5/1/2024 at 3:15 p.m., with Registered Nurse 1 (RN 1), RN 1 stated, “when I went to do the start of care (soc) for Patient 8, another RN shadowed with me. After the visit, I send to my notes to the lead Administrator/Director of Patient Care Services (ADM/DPCS). I don’t have a log in for Sympathy HHA. I have worked for Sympathy part-time since 2022. They have a new system; they have a new website, and I don’t have log in, so ADM/DPCS puts it in for me.” When asked about the handwritten note indicating patient 8 declined PT dated 4/12/2024, RN 1 stated, “I told ADM/DPCS Patient 8 declines PT on SOC (start of care) or so after I saw Patient 8 and she put that note in the chart, I only saw Patient 8 one time on SOC.” During a phone interview with Nurse Practitioner (NP), NP stated, “I have been seeing Patient 8 for a long time now, and last month alone Patient 8 came in on 4/8/2024, on 4/17/2024, and earlier today.” When asked if NP knows of a home health agency that sees Patient 8, or if there are any notifications regarding Patient 8’s ER visit on 4/20/2024 NP stated, “no we did not know Patient 8 has a home health agency. We don't have anything in the system that indicates that. Nothing was ever communicated to us. As a matter of fact, every time Patient 8 comes Patient 8 requests to go back to the rehab because patient was getting physical therapy there and getting weaker. If you look at my note from 4/17/2024, I wrote an order for physical therapy three times a week for eight weeks because Patient 8 came in to request for that. Today's visit was accompanied by a nurse which was strange. I had never seen a nurse come with Patient 8 before. We went over Patient 8’s medications and got rid of the antibiotics Patient 8 had in the system that had expired. Other than that, we have no back-and-forth communication with any home health agency.” During a phone interview on 5/1/2024 at 6 p.m. with referral coordinator (RC) for patient 8’s PCP’s office, RC stated, “I am in charge of writing all the referrals and receiving back and forth correspondence with all agencies. I'm looking over Patient 8’s chart and we don't have anything from home health agency. We didn't know she was receiving home health services. No one notified us. I was asked to send in referrals for physical therapy by the NP and we have been trying to get approval for patient 8 to go back to the rehab Patient 8 was at before but nothing about home health.” During an interview on 5/2/2024 at 1:40 p.m., with ADM/DPCS in conference room of HHA, when asked what the nurse is providing on SOC, ADM/DPCS stated, “We give booklet, where we document visits, POC is in there, emergency preparedness, Emergency contact.” When asked how often an order on POC offered if declined for example physical therapy, ADM/DPCS stated, “we offer it because it’s an outstanding order, so we will reoffer it on an ongoing basis on every visit”. During a record review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, undated, the policy indicated, “each patient will be an active, informed participant in his/her plan of care.” The policy further indicated, “the patient has the right to: Receive all services in the plan of care.” During a record review of the HHA’s policy and procedure titled, “Care Planning Process”, undated, the policy indicated, “all clinicians including the physician involved in the patients care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible…2. All clinicians will consider the conclusion of initial and ongoing assessments in their care planning process, including, but not limited to a. period individualized patient needs, and resultant problems related to care, functional status, and family/caregiver support systems B. Changes in patient’s condition C. Clinical drug monitoring, as appropriate the period pain and symptom management, as appropriate D. Pain and symptom management, as appropriate etc. Psychosocial and spiritual needs of patient and family/caregiver, as appropriate F. Patient treatment choices G. Patient and caregiver education and training that the organization will provide specific to the patient's care needs.” A review of Patient11’s Electronic Medical Record (EM) titled, “Home Health Certification and Plan of Care sheet”, Indicated a start of care date (SOC) of 4/6/2024, for the certification period of 4/6/2024 to 6/4/2024,with diagnoses of Bilateral Primary osteoarthritis( occurs when the cartilage in both knees wears away causing a person's bones to rub together and may have an unknown cause or be the result of general age-related wear and tear) ), Muscle weakness, Atherosclerotic Heart disease(damage or disease in the hearts major blood vessels usually caused by a buildup of fat cholesterol and other substances in or on the artery wall causing obstruction of blood flow) and major depressive disorder The physician ordered Skilled Nurse (SN to visit one time a week for 1 week, two times a week for 1 week, and one time a week for 8 weeks perform skilled assessment/observation of cardiovascular status, vital signs every visit, blood sugar monitoring every visit and report Blood Sugar greater than 300mg/dl and less than 70 mg/dl to MD due to diabetes mellitus. A review of Patient 11’s HHA’s Order/Telephone order, Admission order dated 4/6/2024, at 9:37pm., indicated, “Patient has history of (Diabetes mellitus) DM controlled with diabetic diet and patient and caregiver stated patient is not checking his blood sugar via fingerstick and no available blood sugar machine at this time.” Continued review of Patient 11’s Order/Telephone Order Admission Order dated 4/6/2024, at 9:37 pm., indicated, “refer to Physical Therapy services to but patient caregiver stated to hold physical therapy until patient see his pain management on 6/3/2024.” On 5/1/2024, at 11:30 am., during a joint visit with LVN 2, Patients 11 &12 and their family caregiver (FCG), at the dining table in their residents. Patient 11 and the FCG was asked the reason they declined/delayed Physical Therapy services until 6/3/2024, which was documented in Patients 11’s electronic medical records. Patient 11 and the FCG, both stated that Patient 11 was never offered PT services from the HHA and that she never declined or delayed PT services for Patient 11, The FCG, stated, in fact, Patient 11 would benefit from PT services and really needs it. During a continued interview with Patient 11 and the FCG during the home visit, the FCG stated Patient 11’s diabetes is regulated through diet and monitoring his salt intake. FCG stated she has never used the glucometer to measure patients 11’s blood sugar although she has one because it is not necessary since he does not take any medications for diabetes, and it is regulated through diet. During a concurrent record review and interview with the Administrator/Director of Patient Care Services in the Conference room of the HHA on 5/1/2024, at 3:30 pm. regarding Patient 11's PT order, Patient 11's order for blood sugar monitoring and Patient 11 not being offered or receiving the services per the physician's order, and that LVN 2 was documenting blood sugar ranges on her visits notes when the FCG and patient 11 stated they do not monitor the blood sugar ranges, the administrator stated she did not know what happened and that she was not aware of the PT or blood sugar orders.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on observation, interview and record review the Home Health Agency (HHA) failed to ensure three of five sampled patients (Patient 8, Patient 11, and Patient 12) received information regarding the State toll free home health complaint telephone hotline, its contact information, its hours of operation, and its purpose. This failure resulted in a violation of patient’s rights of not having the information necessary to make a complaint regarding the agency’s care or voice their concerns. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. During an interview with Patient 8, Patient 8 stated, “I have never received any paperwork from the nurses and the home health agency. They never gave me anything. I was not aware there is a hotline number I can call and make a complaint for the state.” A review of Patient 11’s Electronic Medical Record (EM) titled, “Home Health Certification and Plan of Care sheet”, Indicated a start of care date (SOC) of 4/6/2024, for the certification period of 4/6/2024 to 6/4/2024,with diagnoses of Bilateral Primary osteoarthritis( occurs when the cartilage in both knees wears away causing a person's bones to rub together and may have an unknown cause or be the result of general age-related wear and tear) ), Muscle weakness, Atherosclerotic Heart disease(damage or disease in the hearts major blood vessels usually caused by a buildup of fat cholesterol and other substances in or on the artery wall causing obstruction of blood flow) and major depressive disorder. The physician ordered Skilled Nurse (SN to visit one time a week for 1 week, two times a week for 1 week, and one time a week for 8 weeks perform skilled assessment/observation of cardiovascular status, vital signs every visit, blood sugar monitoring every visit and report Blood Sugar greater than 300mg/dl and less than 70 mg/dl to MD due to diabetes mellitus. A review of Patient 12’s Electronic Medical records(EMR) form titled, “Home Health Certification And Plan of Care ” indicated a start of care date (SOC) of 4/6/2024, for the certification period of 4/6/2024 to 6/4/2024, with diagnoses of Bilateral Primary osteoarthritis (occurs when the cartilage in both knees wears away causing a person's bones to rub together and may have an unknown cause or be the result of general age-related wear and tear), Primary Osteoarthritis Left shoulder( OWA has no specific cause but is related to age genes and sex ,usually seen in people over the age of 50 and women are affected more often than men), and Alzheimer’s Disease( a progressive disease that destroys memory and other important mental functions) The physician ordered Skilled Nurse (SN to visit one time a week for 1 week, two times a week for 1 week, and one time a week for 8 weeks, then reassess. The SN is to assess/observation, cardiovascular status for vital signs every visit, musculoskeletal status for weakness, joint pain, BLE pain, generalized body pain for the intensity, frequency and duration. On 5/2/2024, at 11:30 a.m., during a joint home visit with LVN 2, Patients 11, Patient 12 and their caregiver were the patients' residence. Patients 11, Patient 12, and the caregiver were asked if they knew about the State toll free home health complaint hotline and its purpose, they all stated they did not know about it or were to find it inside their HHA's folder in their residence.

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 observation, interview, and record review, HHA failed to ensure the content of the initial comprehensive assessments was accurate for one of five sampled patients (Patient 8). The deficient practice had the potential to place the patient at risk for complications that could affect their overall health status. Findings: A review of Patient 8's Patient Information sheet indicated a Start of Care (SOC) date of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis included hemiplegia following cerebral infarction (paralysis in one side of the body due to the blood flow interruption into the brain cells), weakness, and Type 2 Diabetes (a chronic condition where the body does not produce insulin which regulates the blood sugar). A review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient once a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. A review of Patient 8’s Outcome and Assessment Information Set (OASIS, is a group of standard data elements home health agencies integrate into their comprehensive assessment, to collect and report quality data to the Centers for Medicare & Medicaid Services) indicated: “M1850 Transferring current ability to move safely from bed to chair, or ability to turn and position self in bed if patient is bedfast 1. Able to transfer with minimal human assistance or with use of an assistive device. M1860 ambulation/locomotion current ability to walk safely, once in a standing position, or use a wheelchair, once in a seating position, or a variety of surfaces 3. Able to walk only with the supervision or assistance of another person at all times. Section GG - functional abilities and goals, activities permitted 3. Up as tolerated 9. Cane B. Walker…” During concurrent observation and interview on 5/1/2024 at 11:12 p.m. Patient 8 observed in a wheelchair with no movement of left arm and leg. Patient 8 stated, “I can't walk, I can only use a wheelchair and I need assistance to the wheelchair.” When asked if Patient 8 uses a cane or a walker, Patient 8 responded, “no I only use a wheelchair. I had a stroke so my left side is not working.” During a phone interview on 5/1/2024 at 3:15 p.m. with Registered Nurse 1 (RN 1), RN 1 stated, “when I went to do the start of care (SOC) for Patient 8, another RN shadowed me. After the visit, I sent my notes to the lead Administrator/Director of Patient Care Services ADM/DPCS. I don’t have a log in for the HHA. I have worked for this HHA part-time since 2022. They have a new system; they have a new website, and I don’t have log in so ADM/DPCS puts it in for me.” During an Interview on 5/2/2024 at 1:36 p.m. with ADM/DPCS in the HHA's conference room, ADM/DPCS stated, “I have never visited Patient 8. I did not do the SOC or consents for Patient 8. It was done by RN 1, I just entered the Oasis for RN 1.” A review of the HHA’s undated policy and procedure titled “Reassessments/Update of the Comprehensive Assessment”, indicated, “3. Additionally reassess each patient with each home visit on an ongoing basis to evaluate current problems and needs as well as to adjust the care provided. Such reassessments will be documented on discipline-specific visit notes.” The policy further indicated, “4. Each patient will be reassessed when: a significant change in condition, status, diagnosis, care, environment or support system occurs. A marked improvement or worsening of a patient's condition, which changes, and was not anticipated in, the patient's plan of care would be considered a major decline or improvement in the patient's health status that would warrant update and revision of the comprehensive assessment. Physician/practitioner orders more frequent reassessments. Response to care needs to be reassessed period to satisfy legal or regulatory requirements. 3. Staff will analyze the data from assessments and reassessments. Such analysis of data will assist staff in identifying and prioritizing patient needs and problems to direct care and services.”

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure that the Primary Care Physician (PCP) was notified of change of condition following patient’s hospitalization for one of five sampled patients (Patient 8). This deficient practice resulted in Patient 8 not receiving timely care from the PCP. During a record review of Patient 8's Patient Information sheet indicated, Patient 8 Start of Care (SOC) of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's Patient Information sheet indicated, Patient 8's diagnoses included hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, and type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit Patient 8 once a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. Further review of the POC indicated Physical Therapy to Evaluate and follow treatment. Patient 8's POC indicated that the SN to instruct Patient/patient caregiver on disease process, causes, s/s (signs and symptoms), complications, review and reconcile patient’s medications every visit, teach patient about ordered medications regarding effects, side effects, dosages, and timing; assess effectiveness of current medications, compliance with ordered medications. During a record review of Patient 8’s POC for the certification period from 4/6/2024 to 6/4/2024, included an order for “Skilled Nurse to report /call attending physician if: 5) any incidence of falls/injury, ER visits and/or any hospitalization occurrence 6) any other significant clinical findings.” The POC further indicated “Physical therapy -eval/assess home safety, adls and fall/injury risk, physical therapy to instruct patient on therapeutic exercise regimen for balance, gait training, transfer, mobility skills and use of assistive device for ambulation, safety precautions to prevent fall injury. Physical therapy to notify MD for any critical and significant findings. During an interview on 5/1/2024 at 11:32 a.m. with Patient 8, Patient 8 stated, “I have had several trips to the ER in the last month. Once I went because of pain, another time I went because I took 2 Percocet (is used to relieve moderate to severe pain) within the four hour window and I started hyperventilating I thought I had overdosed. I took a Narcan and then I started getting tingly so I called 911. And then another time I went because of a spider bite.” When asked where she got the orders for Narcan, patient 8 stated, “my pain management doctor, PMP in Rancho.” During a record review of Patient 8’s Hospital Emergency Department Note, dated 4/20/2024, indicated, “Patient 8 is a 66 year old female with a h/o (history of) atrial fibrillation (abnormal heart rhythm), diabetes mellitus type 2, prior stroke with residual left sided deficits and chronic back pain now presenting with tingling of her tongue after using Narcan today. Today she was recently started on a new pain medication (Nucynta), took her Percocet for breakthrough pain after which she felt like she was choking and was concerned she may have overdosed on her medication. She used her Narcan after which she felt tingling sensation in her tongue.” During a phone interview with the Nurse Practitioner (NP), the NP stated, “I have been seeing patient 8 for a long time now, and last month alone patient 8 came in on 4/8/2024, on 4/17/2024, and earlier today.” When asked if NP knows of a home health agency that sees patient 8, or if there is any notifications regarding patient 8’s ER visit on 4/20/2024 NP stated, “no we did not know patient 8 has a home health agency. We don't have anything in the system that indicates that. Nothing was ever communicated to us. As a matter of fact every time patient 8 comes patient 8 requests to go back to the rehab because patient 8 was getting physical therapy there and patient 8's getting weaker. If you look at my note from 4/17/2024, I wrote an order for physical therapy three times a week for eight weeks because patient 8 came in to request for that. Today's visit was accompanied by a nurse which was strange. I had never seen a nurse come with patient 8 before. We went over patient 8’s medications and got rid of the antibiotics patient 8 had in the system that had expired. Other than that we have no back and forth communication with any home health agency.” During a telephone interview on 5/1/2024 at 6:00 p.m. with referral coordinator (RC) for Patient 8’s PCP’s office, RC stated, “I am in charge of writing all the referrals and receiving back and forth correspondence with all agencies. I'm looking over patient 8’s chart and we don't have anything from home health agency. We didn't know she was receiving home health services. No one notified us. I was asked to send in referrals for physical therapy by the NP and we have been trying to get approval for patient 8 to go back to the rehab patient 8 was at before but nothing about home health.” During an interview on 5/2/2024 at 1:35 p.m. with Administrator/Director of Patient Care Services (ADM/DPCS) in conference room of HHA, when asked how often medication reconciliation is done ADM/DPCS stated, “Medication reconciliation is to be done on every visit. For patient 8, we got the medication list from the rehab facility patient 8 was at before patient 8 went home and we used the medication list provided to us from the rehab facility to do the medication reconciliation.” When asked when a physician is notified of any changed, ADM/DPCS stated “we notify MD of change of condition as it occurs, we try to do that day.” When asked how often the nurses are supposed to provide patient education on medications, side effects, polypharmacy, and the disease processes, ADM/DPCS stated, “on an ongoing basis on every visit.” During an interview on 5/2/2024 at 2:02 p.m., with ADM/DPCS about Patient 8's frequent emergency (ER) visits while under the HHA care, ADM/DPCS stated, “well if Patient 8 doesn’t tell us about it we have no way of knowing.” During a record review of the HHA’s policy and procedure titled, “Care Planning Process”, undated, the policy indicated, “ all clinicians including the physician involved in the patients care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible…2. All clinicians will consider the conclusion of initial and ongoing assessments in their care planning process, including, but not limited to: a. period individualized patient needs and resultant problems related to care, functional status, and family/caregiver support systems B. Changes in patient’s condition C. Clinical drug monitoring, as appropriate the period pain and symptom management, as appropriate D. Pain and symptom management, as appropriate etc. Psychosocial and spiritual needs of patient and family/caregiver, as appropriate F. Patient treatment choices G. Patient and caregiver education and training that the organization will provide specific to the patient's care needs.” During a record review of the HHA’s policy and procedure titled, “Monitoring Patient’s Response/ Reporting to Physician”, undated, the policy indicated, “ clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care of the patient. 1. Each home visit, the clinician will monitor the patient's response to care against the established goals, including, but not limited to: A. Care interventions and treatments B. Medications C. Teaching 3. The patient's physician will be contacted on the same day when any of the following occur: a. Changes in the patient's condition B. Changes in the patient's psychosocial status, see. Inability to achieve goals within a specific time frame D. Changes in the patient's expected response to treatment or medications E. Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions, and limitations) F. When there is any problem implementing the plan of care” The policy further indicated, “the organization shall communicate with all physicians involved in the plan of care to avoid duplication or contradictory physician orders and to assure that all patient needs are being met. All physician orders shall be integrated into the plan of care period the plan of care is reviewed and signed by the physician responsible for the plan of care.”

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure to communicate with all physicians prescribing medications in the Plan of Care (POC) for one of five sampled patients (Patient 8). This deficient practice resulted in Patient 8 with multiple medications with different doses from different physicians. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient once a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. Further review of the POC indicated Physical Therapy to Eval and follow treatment. Patient 8's, POC indicated SN to instruct Patient/patient caregiver on disease process, causes, s/s (signs and symptoms), complications, review and reconcile patient’s medications every visit, teach patient about ordered medications regarding effects, side effects, dosages, and timing; assess effectiveness of current medications, compliance with ordered medications. During a record review of Patient 8’s POC for the certification period from 4/6/2024 to 6/4/2024, included an order for “Skilled Nurse to report /call attending physician if: 5) any incidence of falls/injury, ER visits and/or any hospitalization occurrence 6) any other significant clinical findings.” The POC further indicated “Physical therapy -eval/assess home safety, adls and fall/injury risk, physical therapy to instruct patient on therapeutic exercise regimen for balance, gait training, transfer, mobility skills and use of assistive device for ambulation, safety precautions to prevent fall injury. Physical therapy to notify MD for any critical and significant findings. During a record review of Patient 8’s Patient Medication Profile provided by the HHA dated 4/6/2024 indicated the following medications: Duloxetine HCL DR 40mg (medication for depression) 1 capsule by mouth daily. Ducolax suppository (stool softener) 10mg rectally insert 1 suppository as needed for constipation, docusate sodium 250 milligram capsule 1 capsule daily for constipation, beclomethasone dipropionate 40 micrograms/actuation (bronchodilator)nasal HFA inhaler inhale 2 puffs twice daily then rinse with water, Benadryl allergy 25 milligram tablet take two tablets every eight hours as needed for itching, milk of magnesia 400 suspension give 30ML by mouth as needed for constipation, metformin HCL doing 1000 milligrams one tablet by mouth twice daily, Levetiracetam (anti-seizure medication) 500 milligrams one tablet by mouth twice daily, insulin glargine (medication to lower blood sugar) solution get 15 units subcutaneous at bedtime, gabapentin 300 milligram one capsule by mouth twice daily, Trazodone HCL (antidepressant medication) 100 milligram one tablet by mouth daily at bedtime, send an oral tablet 8.6 milligram give 2 tablets by mouth daily for constipation, Protonix Dr. 40 milligram 1 tablet by mouth daily for heartburn, Percocet 10-325 milligram tablet one tablet by mouth every four hours as needed for severe pain, Mylanta maximum strength suspension 400-4000-40 milligrams/5mls give 30ML by mouth every six hours as needed for upset stomach. During a record review of patient 8’s Progress Note from Primary Care Physican’s (PCP) dated 4/8/2024, included the following medications: Imodium A-D 2mg 1 tablet PO( by mouth) qid (four times a day) prn (as needed) loose stool, melatonin 10mg 2 cap PO qhs (every night before bedtime) prn sleep, Basaglar Kwik Pen U-100 Insulin 100 unit/ml (3ml) 10 unit Pen Injector subcutaneous qhs, Jardiance (blood sugar lowering medication) 10mg 1 tab po qam (every morning), pantoprazole 40mg delayed release (acid reducing medication) 1 delay release tab po qam, glipizide 10mg (blood sugar lowing medication) 1 tab po bid (twice a day), metformin 1000mg (blood sugar lowering medication) 1 tab po bid, Actos 15mg (blood sugar lowering medication) 1 tab po qlunch, Diflucan 150mg (anti fungal) 1 tab po once, ciprofloxacin 0.3% eye drops (anti bacterial medication) 2 drops in eye bid, azithromycin 500mg (anti bacterial medication) 1 tab po qday (once a day) Macrobid 100mg (anti bacterial medication) 1cap po bid, Diabetic Tussin DM (cough medication without glucose) 10mg-100ml/5ml oral liquid 10ml liquid po q4h (every 4 hours) prn cough, clotrimazole-betamethasone 1%-0.05% topical cream (used to treat fungal infections) 1 application cream topical bid, trazadone 100mg 1tab po qhs prn insomnia, gabapentin (peripheral nerve pain) 800mg 1tab po tid (three times a day), acetaminophen 500mg 2 tabs po q6h (every 6 hours) prn pain, Vitamin C 500 mg 1 tab po qday, aspirin 81mg (anti-inflammatory and blood thinning medication) tab delayed release, 1tab po qday, Vitamin B-12 500mcg 1 tab po qday, Flonase Allergy relief 50mcg/actuation nasal spray 1 spray intranasal ( in nostrils) qday prn nasal congestion, Cortisporin-TC (anti-bacterial medication for ears) 3.3mg-3mg-10mg-0.5ml ear drops 5 drops otic (ear) qid into left ear, cholecalciferol (vitamin D3) 5000 units 1 cap po qday, amoxicillin 500mg (antibacterial medication) 1 cap po bid, acetaminophen 325 mg 2 tab po q4h prn pain, Eliquis 5 mg (blood thinner) 1 tab po bid, ondansetron 4mg (anti-nausea medication) q4h prn nausea and vomiting, Bactrim DS 800 mg-160 mg (antibacterial medication) 1tab po bid, Silvadene 1% topical cream 1 application cream topical bid prn wound healing, Januvia 100mg (blood sugar lowering medication) 1 tab po qday, Colace 100mg (stool softener) 1 tab po bid, Pyridium 100mg (urinary tract numbing medication) 1 tab po bid prn pain, acetaminophen ER (extended release) 650 mg 2 ER tab po q12h (every 12 hours) prn pain, hydroxyzine HCL 25 mg (allergy medication) 1 tab po qhs prn insomnia, Keppra 500mg (anti-seizure medication) 1 tab po bid, oxybutynin chloride 5mg (medication to treat overactive bladder) 1 tab po qday, lidocaine 5% topical patch (skin patch for pain relief) 1 patch qday for pain relief, fluoxetine 20 mg (used to treat depression) 1 tab po bid, cyanocobalamin (vitamin B12) 1000mcg/ml injection 1ml solution IM ( intra muscular injection) qmonth (every month), amitriptyline 25mg ( antidepression medication) 1 tab po bid, atorvastatin 40 mg (cholesterol lowering medication) 1 tab po qhs. During a record review patient 8’s Pain Management Physician’s (PMP) pain management reevaluation/ follow up visit, dated 4/11/2024, including the following medications; Percocet 7.5mg/325mg (narcotic pain medication) from tid to qid prn pain, Nucynta ER 200 mg (narcotic pain medication extended release capsules) 1 tab po q12h prn baseline pain, Voltaren gel 1% (non steroidal anti-inflammatory pain gel) apply 4g qid to the affected area, Lyrica 75 mg (nerve pain medication) TID, Dayvigo 5 mg (a medication used to treat insomnia) one po qhs , Cymbalta 60 mg (antidepressant and nerve pain medication) one po bid, Celebrex 200 mg (non steroidal anti-inflammatory drug used for pain) one po bid, Ztlido 1.8% (lidocaine pain relief patches) apply one patch on off q12h (every 12 hours), Narcan 4 mg NS (a medication which is used to reverse an overdose of narcotics) nasal spray) quantity of two. During an interview on 5/1/2024 at 11:32 a.m. with patient 8, patient 8 stated, “I have had several trips to the ER in the last month. Once I went because of pain, another time I went because I took 2 Percocet’s within the four hour window and I started hyperventilating I thought I had overdosed. I took a Narcan and then I started getting tingly so I called 911. And then another time I went because of a spider bite.” When asked where she got the orders for Narcan, patient 8 stated, “my pain management doctor, PMP in Rancho.” During an interview on 5/1/2024 at 11:38 a.m. with patient 8’ daughter, patient 8’s daughter stated, “like my mom said we didn't even know she had home health. Like she says she's seen a few of the nurses come by the house but nothing was explained to us.” During a record review of patient 8’s Progress Note from Primary Care Physician’s (PCP) dated 4/17/2024, indicated “Plans/Orders Referrals Refer to: Schedule:4-17-2024 Perform: In-House (STAT- refer pt/ot [physical therapy and occupational therapy] in highland palms nursing home. Please refer to LTC [long term care] facility placement.) Referring MD: refer to pt/ot 3 x week x 8 weeks (3 times a week for 8 weeks). During a phone interview with Nurse Practitioner (NP), NP stated, “I have been seeing patient 8 for a long time now, and last month alone patient 8 came in on 4/8/2024, on 4/17/2024, and earlier today.” When asked if NP knows of a home health agency that sees patient 8, or if there is any notifications regarding patient 8’s ER visit on 4/20/2024 NP stated, “no we did not know patient 8 has a home health agency. We don't have anything in the system that indicates that. Nothing was ever communicated to us. As a matter of fact every time patient 8 comes patient 8 requests to go back to the rehab because patient 8 was getting physical therapy there and patient 8's getting weaker. If you look at my note from 4/17/2024, I wrote an order for physical therapy three times a week for eight weeks because patient 8 came in to request for that. Today's visit was accompanied by a nurse which was strange. I had never seen a nurse come with patient 8 before. We went over patient 8’s medications and got rid of the antibiotics patient 8 had in the system that had expired. Other than that we have no back and forth communication with any home health agency.” During a phone interview on 5/1/2024 at 6:00 p.m. with referral coordinator (RC) for patient 8’s PCP’s office, RC stated, “I am in charge of writing all the referrals and receiving back and forth correspondence with all agencies. I'm looking over patient 8’s chart and we don't have anything from home health agency. We didn't know she was receiving home health services. No one notified us. I was asked to send in referrals for physical therapy by the NP and we have been trying to get approval for patient 8 to go back to the rehab patient 8 was at before but nothing about home health.” During an interview on 5/2/2024 at 11:10 a.m., with medical assistant (MA) at PMP’s clinic, MA stated, “Our office is called and Pain Management Clinic 1 and we have doctor PMP. Patient 8 was last seen by our doctor on 4/11/2024. I could send you the visit notes which will show what was discussed and a list of patient 8’s medications prescribed by our doctor.” when asked if there is any communication regarding patient 8’s ER visit from a home health agency in the system, MA stated, “no there is no notes from any home health agency. We didn’t know patient 8 has home health.” During an interview on 5/2/2024 at 1:30 p.m. with ADM/DPCS in conference room of HHA, when asked how where the medication list was obtained for Patient 8, ADM/DPCS stated, “we got Patient 8’s meds and referral from the rehab facility she was at, and we used that to for the purposed of her current medications for the POC.” When asked if there was any communication with Patient 8’s PCP, ADM/DPCS stated, “no there wasn’t.” During an interview on 5/2/2024 at 1:35 p.m. with ADM/DPCS in conference room of HHA, when asked how often medication reconciliation is done ADM/DPCS stated, “Medication reconciliation is to be done on every visit. For patient 8, we got the medication list from the rehab facility patient 8 was at before patient 8 went home and we used the medication list provided to us from the rehab facility to do the medication reconciliation.” When asked when a physician is notified of any changed, ADM/DPCS stated “we notify MD of change of condition as it occurs, we try to do that day.” During an interview on 5/2/2024 at 1:45 p.m., with Adm/DPCS in conference room of HHA, when asked if the HHA reached out to patients’ other doctor’s to go over medications and see what other medications the patient has, ADM/DPCS stated, “on a as needed basis.” During a record review of the HHA’s policy and procedure titled, “Monitoring Patient’s Response/ Reporting to Physician”, undated, the policy indicated, “ clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care of the patient. 1. Each home visit, the clinician will monitor the patient's response to care against the established goals, including, but not limited to: A. Care interventions and treatments B. Medications C. Teaching 3. The patient's physician will be contacted on the same day when any of the following occur: a. Changes in the patient's condition B. Changes in the patient's psychosocial status, see. Inability to achieve goals within a specific time frame D. Changes in the patient's expected response to treatment or medications E. Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions, and limitations) F. When there is any problem implementing the plan of care” The policy further indicated, “the organization shall communicate with all physicians involved in the plan of care to avoid duplication or contradictory physician orders and to assure that all patient needs are being met. All physician orders shall be integrated into the plan of care period the plan of care is reviewed and signed by the physician responsible for the plan of care.”

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to provide teaching on prescribed medications, side effects, dosages, and timing for one of five sampled patients (Patient 8) and family. This deficient practice resulted in placing Patient 8 at risk for drug-to-drug interaction and serious side effect by not knowing which medications the patient was taking. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. Further review of the POC indicated Physical Therapy to Eval and follow treatment. Furthermore, the POC indicated SN to instruct Patient/patient caregiver on disease process, causes, s/s (signs and symptoms), complications, review and reconcile patient’s medications every visit, teach patient about ordered medications regarding effects, side effects, dosages, and timing; assess effectiveness of current medications, compliance with ordered medications. During a record review of Patient 8’s Patient Medication Profile provided by the HHA dated 4/6/2024 indicated the following medications: Duloxetine HCL DR 40 mg (medication for depression) 1 capsule by mouth daily. Dulcolax suppository (stool softener) 10mg rectally insert 1 suppository as needed for constipation, docusate sodium 250 milligram capsule 1 capsule daily for constipation, beclomethasone dipropionate 40 micrograms/actuation (bronchodilator)nasal HFA inhaler inhale 2 puffs twice daily then rinse with water, Benadryl allergy 25 milligram tablet take two tablets every eight hours as needed for itching, milk of magnesia 400 suspension give 30 ml by mouth as needed for constipation, metformin HCL doing 1000 milligrams one tablet by mouth twice daily, Levetiracetam (anti-seizure medication) 500 milligrams one tablet by mouth twice daily, insulin glargine (medication to lower blood sugar) solution get 15 units subcutaneous at bedtime, gabapentin 300 milligram one capsule by mouth twice daily, Trazodone HCL (antidepressant medication) 100 milligram one tablet by mouth daily at bedtime, send an oral tablet 8.6 milligram give 2 tablets by mouth daily for constipation, Protonix Dr. 40 milligram 1 tablet by mouth daily for heartburn, Percocet 10-325 milligram tablet one tablet by mouth every four hours as needed for severe pain, Mylanta maximum strength suspension 400-4000-40 milligrams/5mls give 30ML by mouth every six hours as needed for upset stomach. During a record review of patient 8’s Progress Note from Primary Care Physician's (PCP) dated 4/8/2024, included the following medications: Imodium A-D 2mg 1 tablet PO( by mouth) qid (four times a day) prn (as needed) loose stool, melatonin 10mg 2 cap PO qhs (every night before bedtime) prn sleep, Basaglar Kwik Pen U-100 Insulin 100 unit/ml (3ml) 10 unit Pen Injector subcutaneous qhs, Jardiance (blood sugar lowering medication) 10 mg 1 tab po qam (every morning), pantoprazole 40 mg delayed release (acid reducing medication) 1 delay release tab po qam, glipizide 10 mg (blood sugar lowering medication) 1 tab po bid (twice a day), metformin 1000 mg (blood sugar lowering medication) 1 tab po bid, Actos 15 mg (blood sugar lowering medication) 1 tab po every lunch, Diflucan 150mg (anti fungal) 1 tab po once, ciprofloxacin 0.3% eye drops (antibacterial medication) 2 drops in eye bid, azithromycin 500 mg (antibacterial medication) 1 tab po qday (once a day) Macrobid 100mg (antibacterial medication) 1 cap po bid, Diabetic Tussin DM (cough medication without glucose) 10mg-100ml/5ml oral liquid 10ml liquid po q4h (every 4 hours) prn cough, clotrimazole-betamethasone 1%-0.05% topical cream (used to treat fungal infections) 1 application cream topical bid, trazodone 100 mg 1 tab po qhs prn insomnia, gabapentin (peripheral nerve pain) 800 mg 1 tab po tid (three times a day), acetaminophen 500 mg 2 tabs po q6h (every 6 hours) prn pain, Vitamin C 500 mg 1 tab po qday, aspirin 81mg (anti-inflammatory and blood thinning medication) tab delayed release, 1 tab po qday, Vitamin B12 500 mcg 1 tab po qday, Flonase Allergy relief 50 mcg/actuation nasal spray 1 spray intranasal ( in nostrils) qday prn nasal congestion, Cortisporin-TC (antibacterial medication for ears) 3.3 mg-3 mg-10 mg-0.5ml ear drops 5 drops otic (ear) qid into left ear, cholecalciferol (vitamin D3) 5000 units 1 cap po qday, amoxicillin 500mg (antibacterial medication) 1 cap po bid, acetaminophen 325 mg 2 tab po q4h prn pain, Eliquis 5 mg (blood thinner) 1 tab po bid, ondansetron 4mg (anti-nausea medication) q4h prn nausea and vomiting, Bactrim DS 800 mg-160 mg (antibacterial medication) 1 tab po bid, Silvadene 1% topical cream 1 application cream topical bid prn wound healing, Januvia 100mg (blood sugar lowering medication) 1 tab po qday, Colace 100 mg (stool softener) 1 tab po bid, Pyridium 100 mg (urinary tract numbing medication) 1 tab po bid prn pain, acetaminophen ER (extended release) 650 mg 2 ER tab po q12h (every 12 hours) prn pain, hydroxyzine HCL 25 mg (allergy medication) 1 tab po qhs prn insomnia, Keppra 500mg (anti-seizure medication) 1 tab po bid, oxybutynin chloride 5mg (medication to treat overactive bladder) 1 tab po qday, lidocaine 5% topical patch (skin patch for pain relief) 1 patch qday for pain relief, fluoxetine 20 mg (used to treat depression) 1 tab po bid, cyanocobalamin (vitamin B12) 1000mcg/ml injection 1ml solution IM ( intramuscular injection) q month (every month), amitriptyline 25mg (anti depression medication) 1 tab po bid, atorvastatin 40 mg (cholesterol lowering medication) 1 tab po qhs. During a record review patient 8’s Pain Management Physician's (PMP) pain management reevaluation/ follow up visit, dated 4/11/2024, including the following medications; Percocet 7.5mg/325mg (narcotic pain medication) from tid to qid prn pain, Nucynta ER 200 mg (narcotic pain medication extended release capsules) 1 tab po q12h prn baseline pain, Voltaren gel 1% (non steroidal anti-inflammatory pain gel) apply 4g qid to the affected area, Lyrica 75 mg (nerve pain medication) TID, Dayvigo 5 mg (a medication used to treat insomnia) one po qhs , Cymbalta 60 mg (antidepressant and nerve pain medication) one po bid, Celebrex 200 mg (non steroidal anti-inflammatory drug used for pain) one po bid, Ztlido 1.8% (lidocaine pain relief patches) apply one patch on off q12h (every 12 hours), Narcan 4 mg NS (a medication which is used to reverse an overdose of narcotics) nasal spray) quantity of two. During an interview on 5/1/2024 at 11:30 a.m. with patient 8, patient 8 stated, “I have seen Licensed Vocational Nurse 2 (LVN 2) a few other times other than last night. LVN has come by the house and did my blood pressure, but LVN 2 has never looked at my medications or went over them with me.” During an interview on 5/1/2024 at 11:32 a.m. with patient 8, patient 8 stated, “I have had several trips to the ER in the last month. Once I went because of pain, another time I went because I took 2 Percocet within the four hour window and I started hyperventilating I thought I had overdosed. I took a Narcan and then I started getting tingly so I called 911. And then another time I went because of a spider bite.” When asked where she got the orders for Narcan, patient 8 stated, “my pain management doctor, PMP in Rancho.” During an interview on 5/1/2024 at 11:35 a.m. with patient 8, patient 8 stated, “no education was ever provided to me by the LVN 2 or the other nurse on medications or anything else, they haven't ever looked at my medications before last night.” During a record review of patient 8’s Hospital Emergency Department Note, dated 4/20/2024, indicated, “Patient 8 is a 66 year old female with a h/o (history of) atrial fibrillation (abnormal heart rhythm), diabetes mellitus type 2, prior stroke with residual left sided deficits and chronic back pain now presenting with tingling of her tongue after using Narcan today. Today she was recently started on a new pain medication (Nucynta), took her Percocet for breakthrough pain after which she felt like she was choking and was concerned she may have overdosed on her medication. She used her Narcan after which she felt tingling sensation in her tongue.” During an interview on 5/2/2024 at 11:10 a.m., with medical assistant (MA) at PMP’s clinic, MA stated, “Our office is called and Pain Management Clinic 1 and we have doctor PMP. Patient 8 was last seen by our doctor on 4/11/2024. I could send you the visit notes which will show what was discussed and a list of patient 8’s medications prescribed by our doctor.” when asked if there is any communication regarding patient 8’s ER visit from a home health agency in the system, MA stated, “no there is no notes from any home health agency. We didn’t know patient 8 has home health.” During an interview on 5/2/2024 at 1:30 p.m. with Adm/DPCS in conference room of HHA, when asked how where the medication list was obtained for Patient 8, ADM/DPCS stated, “we got Patient 8’s meds and referral from the rehab facility she was at, and we used that to for the purpose of her current medications for the POC.” When asked if there was any communication with Patient 8’s PCP, ADM/DPCS stated, “no there wasn’t.” During an interview on 5/2/2024 at 1:35 p.m. with ADM/DPCS in conference room of HHA, when asked how often medication reconciliation is done ADM/DPCS stated, “Medication reconciliation is to be done on every visit. For patient 8, we got the medication list from the rehab facility patient 8 was at before patient 8 went home and we used the medication list provided to us from the rehab facility to do the medication reconciliation.” During an interview on 5/2/2024 at 2:02 p.m., with ADM/DPCS informed her of the ER visits patient 8 has had while under the HHA care, ADM/DPCS stated, “well if patient 8 doesn’t tell us about it we have no way of knowing.” During a record review of the HHA’s policy and procedure titled, “Patient Education Process”, undated, the policy indicated, “patients and family/caregivers will receive education and verbal, visual, and written format, as appropriate..” The policy further indicated, “6. Unless otherwise ordered by the physician (or other authorized license independent practitioner), the patient and family/caregiver will receive verbal and, as appropriate, written instructions on: A. The patient's disease process and prognosis B. The medical regimen C. Medication management and administration D. Food and Drug interactions E. Nutrition interventions, modified diets and oral health F. Prescribed treatments G. Pain management age. H. Consequences of noncompliance I. Basic home safety, including fall prevention strategies J. Personal hygiene and grooming K. Infection prevention and control L. Safe, effective use of equipment and supplies M. Environmental and mobility safety N. Emergency preparedness plan…”

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: The Home Health Agency (HHA) failed to ensure the Condition of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) regarding Organization and Administration of Services was met as follows: Findings 1. The HHA failed to ensure one of five sampled patients (Patient 8) needs were continuously assessed. The failure resulted in patient not receiving all orders on POC and getting weaker. (Refer to G966). 2. The HHA administrative staff failed to ensure one of five sampled patients (Patient 8) received care within acceptable professional standards of practice. The failure resulted in patient feeling fearful and terminating HHA services. (Refer to G984). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (in a way that is decided and controlled by law) compliance with the Federal (government) Regulations for Organization and Administration of Services, to ensure the provision of health care services in a safe manner.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to ensure one of five sampled patients (Patient 8) needs were continuously assessed . The deficient practice resulted in the patient not receiving all orders indicted on the plan of care (POC). During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. Further review of the POC indicated Physical Therapy to evaluate and follow treatment. During a record review of Patient 8’s POC for the certification period from 4/6/2024 to 6/4/2024, included an order for “Skilled Nurse to report /call attending physician if: 5) any incidence of falls/injury, ER visits and/or any hospitalization occurrence 6) any other significant clinical findings.” The POC further indicated “Physical therapy -evaluate /assess home safety, activity of daily livings (adls) and fall/injury risk, physical therapy to instruct patient on therapeutic exercise regimen for balance, gait training, transfer, mobility skills and use of assistive device for ambulation, safety precautions to prevent fall injury. Physical therapy to notify medical doctor (MD) for any critical and significant findings. During a record review of patient 8’s Progress Note from Primary Care Physician's (PCP) dated 4/17/2024, indicated “Plans/Orders Referrals Refer to: Schedule:4-17-2024 Perform: In-House (STAT- refer pt/ot [physical therapy and occupational therapy] in highland palms nursing home. Please refer to LTC [long term care] facility placement.) Referring MD: refer to pt/ot 3 x week x 8 weeks (3 times a week for 8 weeks). During an interview on 5/1/2024 at 11:40 a.m. with patient 8, patient 8 stated, “I don't ever remember declining physical therapy. Maybe if it was offered to me after I had my back injection because I was still in pain, but it was never reoffered to me. I've been coming to my doctor's office for the past month and asking to get physical therapy and to go back to the rehab center to get physical therapy because I've been getting weaker. I didn't know that was something that was available for me.” During a record review of patient 8’s paper chart untitled paper including patient 8’s name dated 4/12/2024, a handwritten note indicated “orders: Hold physical therapy (pt), patient & family request patient in pain.” Clinician Name/Signature not eligible. During an interview on 5/1/2024 at 3:15 p.m. with Registered Nurse 1 (RN 1), RN 1 stated, “when I went to do the start of care (soc) for patient 8, another RN shadowed with me. After the visit, I send to my notes to the lead Administrator/Director of Patient Care Services (ADM/DPCS). I don’t have a log in for Sympathy HHA. I have worked for Sympathy part-time since 2022. They have a new system; they have a new website, and I don’t have log in so ADM/DPCS puts it in for me.” When asked about the handwritten note indicating patient 8 declined PT dated 4/12/2024, RN 1 stated, “I told ADM/DPCS patient 8 declines PT on soc a week or so after I saw patient 8 and she put that note in the chart, I only saw patient 8 one time on soc.” During a phone interview with Nurse Practitioner (NP), NP stated, “I have been seeing patient 8 for a long time now, and last month alone patient 8 came in on 4/8/2024, on 4/17/2024, and earlier today.” When asked if NP knows of a home health agency that sees patient 8, or if there is any notifications regarding patient 8’s ER visit on 4/20/2024 NP stated, “no we did not know patient 8 has a home health agency. We don't have anything in the system that indicates that. Nothing was ever communicated to us. As a matter of fact every time patient 8 comes patient 8 requests to go back to the rehab because patient 8 was getting physical therapy there and patient 8's getting weaker. If you look at my note from 4/17/2024, I wrote an order for physical therapy three times a week for eight weeks because patient 8 came in to request for that. Today's visit was accompanied by a nurse which was strange. I had never seen a nurse come with patient 8 before. We went over patient 8’s medications and got rid of the antibiotics patient 8 had in the system that had expired. Other than that we have no back and forth communication with any home health agency.” During a phone interview on 5/1/2024 at 6:00 p.m. with referral coordinator (RC) for patient 8’s PCP’s office, RC stated, “I am in charge of writing all the referrals and receiving back and forth correspondence with all agencies. I'm looking over patient 8’s chart and we don't have anything from home health agency. We didn't know she was receiving home health services. No one notified us. I was asked to send in referrals for physical therapy by the NP and we have been trying to get approval for patient 8 to go back to the rehab patient 8 was at before but nothing about home health.” During an interview on 5/2/2024 at 1:40 p.m., with ADM/DPCS in conference room of HHA, when asked what is the nurse providing on soc, ADM/DPCS stated, “We give booklet, where we document visits, poc is in there, emergency preparedness, Emergency contact.” When asked how often an order on POC offered if declined for example physical therapy, ADM/DPCS stated, “we offer it because it’s an outstanding order, so we will reoffer it on an ongoing basis on every visit”. During a record review of the HHA’s policy and procedure titled, “Care Planning Process”, undated, the policy indicated, “all clinicians including the physician involved in the patients care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible…2. All clinicians will consider the conclusion of initial and ongoing assessments in their care planning process, including, but not limited to: a. period individualized patient needs and resultant problems related to care, functional status, and family/caregiver support systems B. Changes in patient’s condition C. Clinical drug monitoring, as appropriate the period pain and symptom management, as appropriate D. Pain and symptom management, as appropriate etc. Psychosocial and spiritual needs of patient and family/caregiver, as appropriate F. Patient treatment choices G. Patient and caregiver education and training that the organization will provide specific to the patient's care needs.”

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based an observation, interview and record review the HHA administrative staff failed to ensure one of five sampled patients (Patient 8) received care within acceptable professional standards of practice. The deficient practice resulted in patient feeling fearful and terminating HHA services. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar). During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. During a concurrent observation and interview on 5/1/2024 at 10:00 a.m. with LVN 2 in front of Patient 8’s home, LVN 2 door knocked on the door, and there was no response. A gentleman from the backyard approached and stated he was Patient 8's son and he proceeded to call Patient 8’s phone and there was no answer. He identified LVN 2 and stated, “LVN 2 was here last night at around 9:00pm with someone else very late, which was weird to him. We have cameras around the house.” During a phone interview on 5/1/2024 at 10:05 a.m. with LVN 2, LVN 2 proceeded to call Patient 8's phone, there was no answer. LVN 2 proceeded to call Patient 8’s caregiver who answered the phone. Patient 8’s caregiver stated on speaker she had accompanied Patient 8 to her doctor this morning at 8:00am and they were still waiting in the doctor's office to be seen. During a phone interview on 5/1/2024 at 10:10 a.m. with Patient 8, Patient 8 stated she was in her doctor's office to go over her medications and she couldn't talk she had to get off the phone. During a phone interview on 5/1/2024 at 10:30 a.m. with Patient 8’s daughter, Patient 8’s daughter stated, “my mom is in the doctor's office with her caregiver and one of the HHA agency nurses that showed up to my house last night around 9:00 PM. They texted my mom’s caregiver around 10:00 PM last night to come early this morning because they were going to come to the house around 8:00 AM to go to her doctor's office with her to go over her medications and after that they are going to take her to lunch. My mom was telling me that someone from the state was going to come today, we were under the impression that you were going to go to the doctor's office too with them, because after you spoke to my mom and made the appointment for today, is when the agency called and then later on at night they showed up and started looking at her medications, which they hadn't done before. So we were thinking you're going to come and go to the doctor's office with them too.” During a concurrent observation and interview on 5/1/2024 at 11:00 a.m. arrived at Patient 8’s PCP’s office. Entered office where Patient 8 was sitting in the lobby with her caregiver, daughter, and HHA nurse LVN 1. Patient 8 stated, “we came to the doctor's office this morning because the nurses wanted to go over the medications with my doctor’s office. The LVN 1 and LVN 2 came to the house last night and went over the medications.” During an interview on 5/1/2024 at 11:15 a.m. with Patient 8, Patient 8 stated, “I haven’t received anything from this agency. The two nurses LVN 1 and LVN 2 came to the house last night and were telling me that they gave me something, but they never did. I never received a booklet or any paperwork from them.” During an interview on 5/1/2024 at 11:18 a.m. with Patient 8’s daughter, Patient 8’s daughter stated, “they have never given anything to us. I don’t even know what agency these nurses are from. They came to the house last night late around 9pm but they never gave us any paperwork.” During an interview n 5/1/2024 at 11:20 a.m. with LVN 1, LVN 1 stated, “yes, LVN 2 and I we're at patient 8’s house last night. We went over all the medications Patient 8 had and Patient 8 had a lot of expired medications so we wanted to go over all the medications and see which one Patient 8 needs with her doctor's office. This was my first time seeing Patient 8, so I'm not sure what was done before me. I was told by my ADM/DPCS to come this morning and accompany Patient 8 and the caregiver to the doctor's office to go over the medications.” During a phone interview on 5/2/2024 at 10:00 a.m. with Patient 8’s daughter, Patient 8’s daughter stated, “please provide me with the home health agency’s name and phone number since we don’t have anything from them. I want to call and terminate services for my mom even though my mom never signed anything for them to care for her in the first place. After them showing up the other night like that and showing up the next morning to take my mom to the doctor’s office, my mom is scared. I don’t want them coming to my house.” During a phone interview on 5/2/2024 at 10:30 a.m. with Patient 8’s daughter, Patient 8’s daughter stated, “my mom just called me and said LVN 2 is parked outside our house. I called to terminate services, someone answered first she said one name, then changed her name at the end, she told me their manager ADM/DPCS will call me back. I told my mom not to let them in the house. I got really scared after I saw that my phone number was deleted and blocked from my mom’s phone.” During a phone interview on 5/2/2024 at 11:20 a.m. with Patient 8, Patient 8 stated, “I was scared at the doctor’s office the yesterday when you came. The LVN 1 got really weird when she saw you arrive. When you had called earlier, LVN 1 was telling me to hang up, that’s why I cut the conversation short. LVN 1 was telling me you are just being nosey and not to say anything to you. My phone had also disappeared, but my caregiver said she had last seen LVN 1 had it. When we started asking for it, LVN 1 ended up finding it from my bag and it was on silent. I am handicapped and I just got really scared of them, I didn’t want them to do anything to me so when you came, I was hesitant to speak.” During an interview on 5/2/2024 at 1:33 p.m. with ADM/DPCS in conference room of HHA, when asked what happed with the scheduled home visit for Patient 8, and why there was no notification Patient 8 was going to be taken to the doctor’s office, ADM/DPCS stated, “ LVN 2 and LVN 1 were at the Patient 8’s house yesterday, and she had a lot of expired medications so we needed to have her go to the doctor’s office to go over all the medications.” At 1:50 p.m. requested policy and procedure for acceptable and professional standards of practice, no policy provided.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the HHA admission consent (permission) for one of five sampled patients, (Patient 8) had the patient’s own signature. This failure resulted in the patient receiving HHA services without consent and the potential for a fraud (act of deceiving or misrepresenting) activity. During a record review of Patient 8's Patient Information sheet indicated an SOC of 4/6/2024, with a certification period of 4/6/2024 to 6/4/2024. Patient 8's diagnosis including hemiplegia following cerebral infarction (paralysis on one side of the body due to interruption in the flow of blood into the cells in the brain), weakness, type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) During a record review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 4/6/2024 to 6/4/2024, included an order for the skilled nurse (SN) to visit the patient one a week for one week, twice a week for one week, and once a week for eight weeks; then reassess. Further review of the POC indicated a signature by PCP dated 4/12/2024. During a phone interview with Nurse Practitioner (NP), NP stated, “I have been seeing patient 8 for a long time now, and last month alone patient 8 came in on 4/8/2024, on 4/17/2024, and earlier today.” When asked if NP knows of a home health agency that sees patient 8, or if there is any notifications regarding patient 8’s ER visit on 4/20/2024 NP stated, “no we did not know patient 8 has a home health agency. We don't have anything in the system that indicates that. Nothing was ever communicated to us. As a matter of fact every time patient 8 comes patient 8 requests to go back to the rehab because patient 8 was getting physical therapy there and patient 8's getting weaker. If you look at my note from 4/17/2024, I wrote an order for physical therapy three times a week for eight weeks because patient 8 came in to request for that. Today's visit was accompanied by a nurse which was strange. I had never seen a nurse come with patient 8 before. We went over patient 8’s medications and got rid of the antibiotics patient 8 had in the system that had expired. Other than that we have no back and forth communication with any home health agency.” During a phone interview on 5/1/2024 at 6:00 p.m. with referral coordinator (RC) for patient 8’s PCP’s office, RC stated, “I am in charge of writing all the referrals and receiving back and forth correspondence with all agencies. I'm looking over patient 8’s chart and we don't have anything from home health agency. We didn't know she was receiving home health services. No one notified us. I was asked to send in referrals for physical therapy by the NP and we have been trying to get approval for patient 8 to go back to the rehab patient 8 was at before but nothing about home health.” During a concurrent record review and interview on 5/1/2024 at 12:00 p.m. with Patient 8, of the HHA admission consent form dated 4/6/2024, Patient 8 stated, “that is not my signature. I didn’t sign that. I never signed anything for them.” During a concurrent observation and interview on 5/1/2024 at 12:05 p.m. with Patient 8’s daughter, Patient 8's daughter stated, “that is not my moms signature, she never writes her last name first and that is not her writing. Here is her license, this is what her signature looks like.” Patient 8’s driver license observed, signature on patient 8’s drivers license different than the one on HHA consent form. During a record review of patient 8’s Hospital Emergency Department Note, dated 4/20/2024 at 1:06pm, indicated Patient 8's signature. Patient 8's signature does not match signature on HHA Admission Consent. During an Interview on 5/2/2024 at 1:36 p.m. with ADM/DPCS in conference room of HHA, ADM/DPCS stated, “I have never visited Patient 8. I did not do the SOC or consents for patient 8. It was done by RN 1, I just entered the oasis for RN 1.” During a record review of Patient 8's HHA Admission consent form, dated 4/6/2024, indicated ADM/DPCS signature for witness/ agency representative. A review of Patient11’s Electronic Medical Record (EM) titled, “Home Health Certification and Plan of Care sheet”, Indicated a start of care date (SOC) of 4/6/2024, for the certification period of 4/6/2024 to 6/4/2024,with diagnoses of Bilateral Primary osteoarthritis( occurs when the cartilage in both knees wears away causing a person's bones to rub together and may have an unknown cause or be the result of general age-related wear and tear) ), Muscle weakness, Atherosclerotic Heart disease(damage or disease in the hearts major blood vessels usually caused by a buildup of fat cholesterol and other substances in or on the artery wall causing obstruction of blood flow) and major depressive disorder. The physician ordered Skilled Nurse (SN to visit one time a week for 1 week, two times a week for 1 week, and one time a week for 8 weeks perform skilled assessment/observation of cardiovascular status, vital signs every visit, blood sugar monitoring every visit and report Blood Sugar greater than 300mg/dl and less than 70 mg/dl to MD due to diabetes mellitus. A review of Patient 11’s HHA’s Order/Telephone order, Admission order dated 4/6/2024, at 9:37pm., indicated, “Patient has history of (Diabetes mellitus) DM controlled with diabetic diet and patient and caregiver stated patient is not checking his blood sugar via fingerstick and no available blood sugar machine at this time.” Continued review of Patient 11’s Order/Telephone Order Admission Order dated 4/6/2024, at 9:37 pm., indicated, “refer to Physical Therapy services to but patient caregiver stated to hold physical therapy until patient see his pain management on 6/3/2024.” A review of Patient 11’s Patient Basic Info had the patient’s wrong address. Review of Patient 11’s Nursing Progress Note by Licensed Vocational Nurse (LVN2) dated 4/9/2024, (cont.) by under Assessment (cont.) in Endocrine section Blood sugar ranges box was checked with 90-120mg/dl (unit of measure) in small narrative section it indicated, Patient is diabetic controlled with diabetic diet as directed by MD. Patient caregiver stated that patient refused to check blood sugar at this time, patient denies signs and symptoms of hypo/hyperglycemia noted. A review of Patient 11’ Nursing Progress Note by LVN2, dated 4/12/2024, under assessment in the endocrine section, boxes were blank, was checked with no blood sugar measurements, in small narrative section it indicated, Patient is diabetic controlled with diabetic diet as directed by MD. Patient caregiver stated that patient refused to check blood sugar at this time, patient denies signs and symptoms of hypo/hyperglycemia noted. A review Of the same Nursing Progress Notes (cont.) under Approximate Date and Plan For the next Visit, (LVN2) documented, blood sugar checked via fingerstick by patient/caregiver daily.” A review of Patient 11’ Nursing Progress Note by LVN2, dated 4/17/2024, under assessment in the endocrine section, boxes were blank, was checked with no blood sugar measurements, in small narrative section it indicated, Patient is diabetic controlled with diabetic diet as directed by MD. Patient caregiver stated that patient refused to check blood sugar at this time, patient denies signs and symptoms of hypo/hyperglycemia noted. A review Of the same Nursing Progress Notes (cont.) under Approximate Date and Plan For the next Visit, (LVN2) documented, blood sugar checked via fingerstick by patient/caregiver daily.” A review of Patient 11’ Nursing Progress Note dated 4/24/2024, under assessment in the endocrine section RBS was checked with no blood sugar measurements, in small narrative section it indicated, Patient is diabetic controlled with diabetic diet as directed by MD. Patient caregiver stated that patient refused to check blood sugar at this time, patient denies signs and symptoms of hypo/hyperglycemia noted. A review Of the same Nursing Progress Notes (cont.) under Approximate Date and Plan For the next Visit, LVN 2 documented, blood sugar checked 155mg/dl (unit of measure)

The following reflects the findings of the California Department of Public Health during the Complaint Validation survey from 12/6/2023 to12/8/2023. Complaint numbers: #101721 and #101851 Representing the Department of Public Health: Health Facilities Evaluator Nurse: Surveyor ID: 19096 Surveyor ID: 44916 The Inspection was limited to the specific complaint investigated and does not represent the findings of a full inspection of the facility. On 10/5/2023 the Center for Medicare and Medicaid Services (CMS) authorized to conduct a complaint validation survey to review the agency's compliance with Conditions of Participation. Sample Size: 7 Active Census: 22 Unduplicated Census: 61 The following Conditions of Participation were not met: 484.55 Comprehensive Assessments of Patients 484.60 Care Planning, Coordination and Quality of Care 484.70 Skilled Professional Services 484.65 Quality Assessment/Performance Improvement 484.110 Clinical Records

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 interview and record review, the home health agency HHA) (failed to ensure the Condition of Participation was met as follows: 1. The HHA failed to complete the patient's initial comprehensive assessment for three of seven sampled patients (Patients 4, 5 and 6). This deficient practice had the potential to place the patient at risk for complications that could affect their overall health status. (Refer to G 520) 2. The HHA failed to ensure the patients individualized plan of care was reviewed and signed by the attending physician for three of six sampled patients (Patient 1, 2, 3). This deficient practice resulted in the HHA providing care/treatments to the patients without a signed physician's order. (G 536) The cumulative effects of these systemic practices resulted in the failure of the HHA to deliver statutory mandated compliance with the Federal regulations for Comprehensive Assessment of patients.

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 interview and record review, the home health agency failed to complete the patient's initial comprehensive assessment in a timely manner for three of seven sampled patients (Patients 4, 5 and 6). This deficient practice had the potential to place the patient at risk for complications that could affect their overall health status. a. A review of Patient 4's clinical record indicated a referral date of 8/4/2023 and a start of care (SOC) date of 8/10/2023, with a diagnosis of unspecified multiple injuries. A review of the Patient 4's electronic medical record dated 8/10/2023 to 10/28/2023, revealed that there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR- allows the electronic entry, storage, and maintenance of digital medical data. EMR contains the patient's records) A review of the Patient 4's electronic medical record dated 10/9/2023 to 12/7/2023, revealed that there was no documented recertification assessment for the second benefit period completed in the electronic medical record. A review of the “Communication Log” on the EMR for this patient revealed no documented evidence of a change in any start of care dates per family or doctors request. b. A review of Patient 5's electronic medical record indicated a referral date of 7/26/2023 and a start of care date of 8/2/2023, with a diagnosis of autistic disorder (a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave) and epilepsy ("seizure disorders a brain condition that a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. A review of the Patient 5's electronic medical record dated 8/2/2023 to 9/30/2023, revealed that there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR). A review of the Patient 5's electronic medical record dated 10/1/2023 to 11/29/2023 and 11/30/2023 to 1/28/2024 revealed that there was no documented recertification assessment for the second and third benefit period completed in the electronic medical record. c. A review of Patient 6's electronic medical record indicated a referral date of 8/21/2023 and a start of care date of 8/31/2023, with a diagnosis of autistic disorder an intellectual disability (a disability that affects the acquisition of knowledge and skills, any of various neurodevelopmental conditions affecting intellectual processes, educational attainment, and the acquisition of skills needed for independent living and social functioning). A review of Patient 6's electronic medical record dated 8/31/2023 to 10/29/2023, revealed there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR). A review of the Patient 6's electronic medical record dated 10/1/2023 to 11/29/2023 and 11/30/2023 to 1/28/2024 revealed there was no documented recertification assessment for the second and third benefit period completed in the electronic medical record. During an interview with Director of Nursing/Administrator (DON/Admin) at 1:00 p.m., the DON/Admin stated the HHA follows hybrid charting (electronic and paper charts). The DON/Admin stated "The registered nurse who conducted the initial visit failed to complete her comprehensive assessment. The initial comprehensive assessment should be completed no later than five calendar days after the start of care." The DON/Admin stated, If there is a delay of care for example and the patient is still in the hospital or for whatever reason it may have been, we call to the office and reestablish another visit. When asked where they document the communication, the DON/Admin stated they just call the office. The DON/Admin stated “If there is a change of admission date, she stated I don’t know, I may have to look into the policy.” The DON/Admin stated they have 72 hours to initiate the SOC from the date of the referral, unless the family or patient requested to do the SOC on a different date. We call the office and tell them the schedule of the SOC date. A review of the HHA’s policy titled “Initial and Comprehensive Assessment” revised 4/2020 indicated to provide guidelines for the initial assessment of patients admitted to service and for completing the plan of care. An initial patient assessment will be performed and documented in the patient's clinical record by a registered nurse, physical therapist, or speech therapist. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient's return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or another authorized licensed independent practitioner). A comprehensive patient assessment will be completed within five (5) calendar days of the patient's start of care. The last five (5) days of every 60-day episode beginning with the start of care date (recertification). Upon transfer Significant change in condition resulting in a new case mix. Within 48 hours of the patient's return home or of the organization's knowledge of the patient's return from a 24-hour hospital admission for other than diagnostic testing, or on the physician-ordered resumption date and at discharge. A plan of care will be developed from the information gathered during the initial and comprehensive assessment. The patient's physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed. Based on the communication with the physician (or other authorized licensed independent practitioner), a verbal order will be obtained for any change in the plan of care and communicated to all appropriate team members to ensure that care is provided according to the revised plan of care.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency ( HHA) failed to review and update the “Medication Profile” (the information about the medicines a person is using and has used) for one of six sample patients (Patient 1). This failure resulted in a lack of communication between Patient 1’s family member and the agency regarding patient 1’s updated medications ordered. This failure also had a potential to result in ineffective drug therapy and medication interactions. A review of Patient 1’s facesheet indicated a start of care date (SOC) of 4/15/2023, with a diagnoses of cerebral palsy (a congenital disorder of movement, muscle tone, or posture) and legally blind (total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning. The physician ordered Licensed Vocational Nurse (LVN) for up to 12 hours (hrs) a day for vital sign monitoring, perform skilled assessment and observation of body systems with emphasis on neurological safety and medication administration. During an observation, at a home visit conducted on 12/7/2023, at 5 PM at PAtient 1's residence. During an observation and concurrent medication reconciliation with Patient 1’s Family member and the LVN. Patient 1’s family member stated the only medication Patient 1 is taking is albuterol Sulfate 2.5 mg/3ml solution for inhalation every six hours as needed, and albuterol Sulfate 0.083% ( 3ml) every six hours as needed for asthma. Patient 1’s family member also stated the following medications have not been taken for over a month: Ibuprofen 800 mgs tablet twice a day (a synthetic compound used widely as an analgesic and anti-inflammatory drug.) Topiramate .25 mg 2 tablets orally 2 times a day (a medication used to manage and treat epilepsy and migraine). Topiramate 100 mg. 1 tablet by mouth three times a day. Boost Kid Essentials 1.5 liquid suspension ( 1.5 cal – supplemental sole-source of nutrition) three times a day. Family member 1 stated she has been using natural herbs for Patient 1 for the last 3 with the herbal remedies listed below. Family Member 1 showed the containers of the herbs Patient 1 was currently taking. The following medications were not listed on Patient 1’s current medication profile for the certification period of 10/12/2023 through 12/10/2023. Ashwagandha root (have a calming effect on anxiety symptoms significantly reduced people's stress levels this included reduced levels of cortisol which is a stress hormone.) Xiang Fu ( Nutgrass Rhiazone)-( A Chinese herb/medicine used to regulate liver and menstruation and alleviate pain ) Red Clover Flowers (used medically to treat several conditions including cancer, respiratory problems, and skin inflammation such as psoriasis and eczema,) During an interview with the Administrator/DPCS in the conference room of the HHA on 12/8/2023, at 3pm. she stated the medication profile should have been updated at every visit. "A review of the agency's undated policy and procedure titled "Contents of the Clinical Record" policy No. 5-005.1, under procedure section DD stipulates, the current medication profile should include prescription and nonprescription medications, herbal products and home remedies, dose, strength, frequency, route, date and time of administration, and new, changed, or discontinued medication."

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 interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Care planning, Coordination, and Quality of Care was met as follows: 1. The HHA failed to ensure the patients individualized plan of care was reviewed and signed by the attending physician for three of six sample patients (Patient 1,Patient 2,and Patient 3).(Refer to G572) 2. The HHA failed to ensure the agency's physician review and or revise the individualized plans of care (POC) for five out of seven sampled patients (Patients 1, Patient 2, Patient 3, Patient 4 and Patient 5). (Refer to G588) The cumulative effects of these deficient practices resulted in the failure of the Home Health Agency (HHA) to deliver statutorily mandated compliance of the Federal regulations for care planning, coordination, quality of care to ensure provision of highest quality patient care and services.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the HHA failed to ensure the patients individualized plan of care was reviewed and signed by the attending physician for three of six sample patients (1, 2, 3). This deficient practice resulted in the HHA providing care/treatments to the patients without a signed physician's order . Findings: 1. A review of Patient 1’s facesheet, indicated a start of care date (SOC) of 4/15/2023, with a diagnoses of cerebral palsy (a congenital disorder of movement, muscle tone, or posture) and legally blind (total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning. The physician order indicated Patient 1 was to have Licensed Vocational Nurse (LVN) visits for up to 12 hours a day for vital sign monitoring, skilled assessment and observation of body systems with emphasis on neurological safety and medication administration. A review of Patient 1’s electronic medical record (EMR) indicated there was no physician’s signature on the following plan of care (POC) and the certification period: Review of patient 1’s POC for the certification period of 4/15/2023 to 6/13/2023, indicated there was no physician’s signature on Patient 1’s POC. Review of Patient 1’s POC for the certification period of 6/12/2023 to 8/12/2023, indicated there was no physician’s signature on patient 1’s POC. Review of Patient 1’s POC for the certification period of 8/11/2023 to 10/11/2023, indicated there was no physician’s signature on patient 1’s POC. Review of Patient 1’s POC for the certification period of 10/12/2023 to 12/10/2023, there was no physician’s signature on Patient 1’s POC. 2. A review of Patient 2’s “Face Sheet” indicated a start of care date (SOC) of 2/9/2023, with diagnoses of spastic quadriplegic cerebral palsy ( a severe type that is characterized by paralysis of both arms and both legs, with muscle stiffness). The physician order indicated Patient 2 was to have Licensed Vocational Nurse (LVN) for up to 12 hours a day for vital sign monitoring, perform skilled assessment and observation of body systems with emphasis on neurological safety and medication administration. A review of Patient 2’s electronic medical record indicated there was no physician’s signature on the following plan of cares (POC) for the following certification periods: Review of Patient 2’s POC for the certification period of 2/9/2023 to 4/9/2023, indicated there was no physician’s signature on Patient 2’s POC. Review of Patient 2’s POC for the certification period of 4/10/2023 to 6/8/2023, indicated there was no physician’s signature on Patient 2’s POC. Review of Patient 2’s POC for the certification period of 6/9/2023 to 8/7/2023, indicated there was no physician’s signature on the POC. Review of Patient 2’s POC for the certification period of 8/8/2023 to 10/6/2023, indicated there was no physician’s signature on Patient 2’s POC. Review of Patient 2’s POC for the certification period of 10/7/2023 to 12/5/2023, indicated there was no physician’s signature on patient 2’s POC. 3. A review of Patient 3’s “Face Sheet” indicated a start of care date (SOC) of 6/5/2023, with diagnosis of chronic hepatitis C (an infection caused by a virus that attacks the liver and causes inflammation which is caused by contact with contaminated blood), and fracture of the lower left leg (a break or crack in one of the bones in your leg). The physician order indicated Patient 3 was to have Licensed Vocational Nurse (LVN) visits for up to 12 hours a day for assessment of all body systems, vital sign monitoring, observation, teaching and instructions on disease process, diet and medication compliance and perform skilled assessment and observation of body systems. A review of Patient 3’s electronic medical record indicated there was no physician’s signature on the following plan of cares (POC) for the following certification periods: Review of patient 3’s POC for the certification period of 6/5/2023 to 8/3/2023, indicated there was no physician’s signature on Patient 3’s POC. Review of Patient 3’s POC for the certification period of 8/4/2023 to 10/2/2023, indicated there was no physician’s signature on patient 3’s POC. Review of Patient 3's POC for the certification period of 10/3/2023 to 12/1/2023, indicated there was no physician’s signature on Patient 3’s POC. During an interview with the ADM/DPCS in the HHA's Conference room on 12/8/2023, at 3pm. she stated the physician's do not want to sign the POC and no one had followed up. At that time, she was informed by the survey team that an unsigned POC was an unsigned physician's order for provision of care that was being provided by the HHA staff to the patients. A review of the HHA's undated policy and procedure titled, "Provision of Care and Management, Policy No. 4-002.2," under Procedure # 5, and 6 indicated," The attending physician will sign the plan of care/treatment within 30 days of the start of care. The attending physician's recertification will be obtained in intervals of at least every 60 days when the patient's plan of care is reviewed. The patient recertified, and more often, if warranted.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency's physician failed to review and or revise the individualized plans of care (POC) for 5 out of 7 sampled patients (Patients 1, 2, 3, 4 and 5). This failure had the potential to result in the delay of identifying the progress or decline of care and treatment indicated on the POC for further intervention, treatment, and care services that has a direct impact of the patients' quality of care and well-being. Findings: 1. A review of Patient 1’s facesheet Indicated a start of care date (SOC) of 4/15/2023, with diagnoses of cerebral palsy (a congenital disorder of movement, muscle tone, or posture) and legally blind (total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning). A review of Patient 1's plan of care (POC) included a physician's order for the Licensed Vocational Nurse (LVN) to visit 12 hours a day for vital signs monitoring, assessment and observation of body systems with emphasis on neurological safety and medication administration. A review of Patient 1’s electronic medical record indicated the POC for certification and recertification indicated no physician’s signatures to the following certification periods: A review of Patient 1’s POC for the certification period of 4/15/2023 to 6/13/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Review of Patient 1’s POC for the certification period of 6/12/2023 to 8/12/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Review of Patient 1’s POC for the certification period of 8/11/2023 to 10/11/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Review of Patient 1’s POC for the certification period of 10/12/2023 to 12/10/2023, indicated there was no physician’s signature on Patient 1’s POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. 2. A review of Patient 2’s “Facesheet indicated a start of care date (SOC) of 2/9/2023, with diagnoses of spastic quadriplegic cerebral palsy (a severe type that is characterized by paralysis of both arms and both legs, with muscle stiffness). A review of Patient 2's POC included a physician's order for Licensed Vocational Nurse (LVN) to visit for up to 12 hours day for vital sign monitoring, skilled assessment, and observation of body systems with emphasis on neurological safety and medication administration. A review of Patient 2’s electronic medical record indicated there were no physician’s signatures on the POC for the following certification periods: A review of Patient 2’s POC for the certification period of 2/9/2023 to 4/9/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 4/10/2023 to 6/8/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 6/9/2023 to 8/7/ 2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 8/8/2023 to 10/6/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 10/7//2023 to 12/5/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. 3. A review of Patient 3’s facesheet indicated a start of care date (SOC) of 6/5/2023, with diagnosis of chronic hepatitis C (an infection caused by a virus that attacks the liver and causes inflammation which is caused by contact with contaminated blood), and fracture of lower left leg (a break or crack in one of the bones in your leg). A review Patient 3's POC included a physician's order for a Licensed Vocational Nurse (LVN) to visit 12 hours a day for assessment of all body systems, vital sign monitoring, observation, teaching and instructions on disease process, diet and medication compliance and perform skilled assessment and observation of body systems. A review of Patient 3’s electronic medical record indicated there were no physician’s signatures on POC to the following certification periods: Patient 3’s POC for the certification period of 6/5/2023 to 8/3/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Patient 3’s POC for the certification period of 8/4/2023 to 10/2/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Patient 3's POC for the certification period of 10/3/2023 to 12/1/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. a. A review of Patient 4's clinical record indicated a referral date of 8/4/2023 and a start of care (SOC) date of 8/10/2023, with a diagnosis of unspecified multiple injuries. A review of the Patient 4's electronic medical record dated 8/10/2023 to 10/28/2023, revealed that there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR- allows the electronic entry, storage, and maintenance of digital medical data. EMR contains the patient's records) A review of the Patient 4's electronic medical record dated 10/9/2023 to 12/7/2023, revealed that there was no documented recertification assessment for the second benefit period completed in the electronic medical record. There was no documented case summary for this certification periods. A review of the “Communication Log” on the EMR for this patient revealed no documented evidence of a change in any start of care dates per family or doctors request. b. A review of Patient 5's electronic medical record indicated a referral date of 7/26/2023 and a start of care date of 8/2/2023, with a diagnosis of autistic disorder (a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave) and epilepsy (seizure disorders, a brain condition that a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. A review of the Patient 5's electronic medical record dated 8/2/2023 to 9/30/2023, revealed there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR). A review of Patient 5's electronic medical record dated 10/1/2023 to 11/29/2023 and 11/30/2023 to 1/28/2024 revealed there was no documented recertification assessment for the second and third benefit period completed in the electronic medical record. There was no documented case summary for this certification period. During an interview with the Director of Nursing/Administrator (DON/Admin) on 12/8/2023 at 1:00 p.m., stated the people involved in the case summary include the Registered Nurse (RN), Licensed Vocational Nurse (LVN), Home health aide (HHA), Administrator/Director of Nursing (Admin/DON), Social Worker (SW), or any ancillary personnel, and the Medical Director (MD). Admin/DON stated we all come to the office or through phone to conduct our case conferences. The Admin/DON confirmed that she could not find the documentation on her computer for the Case Summary Meetings. A review of the HHA’s policy titled “Initial and Comprehensive Assessment” revised 4/2020 indicated that a plan of care will be developed from the information gathered during the initial and comprehensive assessment. The patient's physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed. Re-assessments should focus on: Patient's response to care. changes in patient condition. changes in patient diagnoses, changes in patient's care environment or support system, When a patient is receiving only personal care and support services, the reassessment will occur at least every six (6) months or more often, as necessary. Based on each reassessment, the plan of care, including problems, needs, goals, and outcomes will be reviewed and revised accordingly by the clinician. Findings: 1. A review of Patient 1’s facesheet Indicated a start of care date (SOC) of 4/15/2023, with diagnoses of cerebral palsy (a congenital disorder of movement, muscle tone, or posture) and legally blind (total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning). A review of Patient 1's plan of care (POC) included a physician's order for the Licensed Vocational Nurse (LVN) to visit 12 hours a day for vital signs monitoring, assessment and observation of body systems with emphasis on neurological safety and medication administration. A review of Patient 1’s electronic medical record indicated the POC for certification and recertification indicated no physician’s signatures to the following certification periods: A review of Patient 1’s POC for the certification period of 4/15/2023 to 6/13/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Review of Patient 1’s POC for the certification period of 6/12/2023 to 8/12/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Review of Patient 1’s POC for the certification period of 8/11/2023 to 10/11/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Review of Patient 1’s POC for the certification period of 10/12/2023 to 12/10/2023, indicated there was no physician’s signature on Patient 1’s POC to indicate the POC was reviewed or revised at the end of the certification period (60 days) to identify progress or decline of the patient's clinical status, treatment, and care services rendered. 2. A review of Patient 2’s “Facesheet indicated a start of care date (SOC) of 2/9/2023, with diagnoses of spastic quadriplegic cerebral palsy (a severe type that is characterized by paralysis of both arms and both legs, with muscle stiffness). A review of Patient 2's POC included a physician's order for Licensed Vocational Nurse (LVN) to visit for up to 12 hours day for vital sign monitoring, skilled assessment, and observation of body systems with emphasis on neurological safety and medication administration. A review of Patient 2’s electronic medical record indicated there were no physician’s signatures on the POC for the following certification periods: A review of Patient 2’s POC for the certification period of 2/9/2023 to 4/9/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 4/10/2023 to 6/8/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 6/9/2023 to 8/7/ 2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 8/8/2023 to 10/6/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. A review of Patient 2’s POC for the certification period of 10/7//2023 to 12/5/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. 3. A review of Patient 3’s facesheet indicated a start of care date (SOC) of 6/5/2023, with diagnosis of chronic hepatitis C (an infection caused by a virus that attacks the liver and causes inflammation which is caused by contact with contaminated blood), and fracture of lower left leg (a break or crack in one of the bones in your leg). A review Patient 3's POC included a physician's order for a Licensed Vocational Nurse (LVN) to visit 12 hours a day for assessment of all body systems, vital sign monitoring, observation, teaching and instructions on disease process, diet and medication compliance and perform skilled assessment and observation of body systems. A review of Patient 3’s electronic medical record indicated there were no physician’s signatures on POC to the following certification periods: Patient 3’s POC for the certification period of 6/5/2023 to 8/3/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Patient 3’s POC for the certification period of 8/4/2023 to 10/2/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. Patient 3's POC for the certification period of 10/3/2023 to 12/1/2023, indicated there was no physician’s signature on the POC to indicate the POC was reviewed or revised at the end of the certification period (60 days), to identify progress or decline of the patient's clinical status, treatment, and care services rendered. a. A review of Patient 4's clinical record indicated a referral date of 8/4/2023 and a start of care (SOC) date of 8/10/2023, with a diagnosis of unspecified multiple injuries. A review of the Patient 4's electronic medical record dated 8/10/2023 to 10/28/2023, revealed that there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR- allows the electronic entry, storage, and maintenance of digital medical data. EMR contains the patient's records) A review of the Patient 4's electronic medical record dated 10/9/2023 to 12/7/2023, revealed that there was no documented recertification assessment for the second benefit period completed in the electronic medical record. There was no documented case summary for this certification periods. A review of the “Communication Log” on the EMR for this patient revealed no documented evidence of a change in any start of care dates per family or doctors request. b. A review of Patient 5's electronic medical record indicated a referral date of 7/26/2023 and a start of care date of 8/2/2023, with a diagnosis of autistic disorder (a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave) and epilepsy (seizure disorders, a brain condition that a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. A review of the Patient 5's electronic medical record dated 8/2/2023 to 9/30/2023, revealed there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR). A review of Patient 5's electronic medical record dated 10/1/2023 to 11/29/2023 and 11/30/2023 to 1/28/2024 revealed there was no documented recertification assessment for the second and third benefit period completed in the electronic medical record. There was no documented case summary for this certification period. During an interview with the Director of Nursing/Administrator (DON/Admin) on 12/8/2023 at 1:00 p.m., stated the people involved in the case summary include the Registered Nurse (RN), Licensed Vocational Nurse (LVN), Home health aide (HHA), Administrator/Director of Nursing (Admin/DON), Social Worker (SW), or any ancillary personnel, and the Medical Director (MD). Admin/DON stated we all come to the office or through phone to conduct our case conferences. The Admin/DON confirmed that she could not find the documentation on her computer for the Case Summary Meetings. A review of the HHA’s policy titled “Initial and Comprehensive Assessment” revised 4/2020 indicated that a plan of care will be developed from the information gathered during the initial and comprehensive assessment. The patient's physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed. Re-assessments should focus on: Patient's response to care. changes in patient condition. changes in patient diagnoses, changes in patient's care environment or support system, When a patient is receiving only personal care and support services, the reassessment will occur at least every six (6) months or more often, as necessary. Based on each reassessment, the plan of care, including problems, needs, goals, and outcomes will be reviewed and revised accordingly by the clinician.

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 observation, interview and record review, the agency failed to ensure the Condition of Participation for Quality assessment/performance improvement were met as follows: 1. Failed to collect quarterly data to ensure a functioning QAPI program (Refer to G644). 2. Failed to ensure the agency had ongoing performance improvement projects. (Refer to G658) The cumulative effects of these systemic practices resulted in the agencies failure to ensure the QAPI program improved patient 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 interview and record review, the home health agency failed to collect data for their Quality Assurance and Performance Improvement (QAPI- is a data driven and proactive approach to quality improvement) quarterly to be able to identify problems and ensure quality of care is being provided. This failure had the potential to affect services being provided. A request was made for the program data for the QAPI program on 12/08/2023 at 1:00 p.m. from the Director of Nursing/Administrator (DON/Admin). On concurrent review of their QAPI with the DON/Admin, the DON/Admin revealed that their QAPI was not evaluated for four years. The DON stated the purpose of the Quality Assessment and Performance Improvement (QAPI) program was to ensure quality of service, identify problem areas, and improve patient care. A review of the HHA'S policy and procedure titled "Quality Assessment and Performance Improvement Plan and Program" revised 4/2020, indicated the agency will establish an on-going, data -driven program of quality assessment and performance improvement. The policy stated the agency will maintain documentary evidence of its program. The policy indicated the purpose of the program are as follows; to improve processes of patient care/services as well as outcomes of care; communicate information internally and externally; use a systematic approach to problem identification and resolution; and conform to all applicable federal/state rules and regulations. A review of the HHA's policy titled " Annual organization Evaluation" dated 4/2020 indicated that the organization will appoint an authorized group or oversight committee (Professional Advisory Committee, Administrator, Director of Patient Care Services, at least one (1) physician, and other licensed professionals representative of the services provided) to conduct an annual evaluation to assess the organization's program. The complexity of the organization and the scope of services and products will define the parameters for data collection. The evaluation will include an analysis of the effectiveness of the organizational administrative practices, risk management, human resources, financial performance, and policies and procedures based on defined measures of program appropriateness and efficiency. The Annual Evaluation Report is submitted to the appropriate oversight committees and the Governing Body for review. Portions of the annual evaluation may be used by the Marketing Department and to construct the annual report, if applicable.

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, the home health agency (HHA) failed to ensure performance improvement projects (PIP- is a concentrated effort on a particular problem in one area of the facility or facility wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) were conducted per facility policy in a timely manner. This failure had the potential to affect the quality of care provided to the patients. A request was made on 12/08/2023, at 1:00 p.m., to the Director of Nursing/Administrator (DON/Admin) for the performance improvement projects (PIP) derived from the data collected from the QAPI program. The DON/Admin stated she is aware of the requirement and upon review of the PIP one goal stated was timely submission of the documentations in the electronic medical record (EMR-allows the electronic entry, storage, and maintenance of digital medical data) and staff were still not logging/sending notes in a timely manner in the EMR.During a concurrent interview and record review of their PIP on the same date and time with the DON/Admin, the DON/Admin stated the last review was 2019. The DON/Admin confirmed that the last review for for the agency's PIP was four years ago. A review of the HHA's policy titled " Annual Organization Evaluation" revised 4/2020 indicated that The organization will appoint an authorized group or oversight committee (Professional Advisory Committee, Administrator, Director of Patient Care Services, at least one (1) physician, and other licensed professionals representative of the services provided) to conduct an annual evaluation to assess the organization's program. The complexity of the organization and the scope of services and products will define the parameters for data collection. The evaluation will include an analysis of the effectiveness of the organizational administrative practices, risk management, human resources, financial performance, and policies and procedures based on defined measures of program appropriateness and efficiency. The Annual Evaluation Report is submitted to the appropriate oversight committees and the Governing Body for review. Portions of the annual evaluation may be used by the Marketing Department and to construct the annual report, if applicable A review of the HHA"S policy and procedure titled "Patient Focused Performance Improvement" revised 4/2020, indicated The organization's performance improvement processes will focus on the quality of patient and program outcomes. In addition, the assessment, planning, implementation of care and services, and evaluation of goal attainment will be individualized to the specific patient. As part of the organization-wide performance improvement process, opportunities for improvement related to patient outcomes will be identified through continuous measurement of patient satisfaction survey results, clinical record review, monitoring of incidents, complaints, grievances, and infection control reports and Potentially Avoidable Reports. Program, or process related performance improvement activities will focus on opportunities to improve overall organizational performance. When an opportunity to improve performance is identified, a focused study (indicator) will be developed to measure and improve associated processes. Performance improvement documentation will be maintained by the Performance Improvement Coordinator.

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 interview, and record review, the home health agency (HHA) failed meet the Conditions of Participations for Skilled Professional services, as follows: 1. Failure to ensure that there was an ongoing interdisciplinary assessment for Patients 4 and 5 ( Refer to G706) 2. Failure to ensure that nursing services were supervised by a Registered Nurse For Patient 1, Patient 2 and Patient 3 (Refer to G726). The cumulative effects of these deficient practices resulted in the failure of the HHA to deliver statutorily mandated compliance of the Federal regulations for Skilled Professional Services to ensure provision of highest quality patient care and services.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure interdisciplinary team meetings (a group of health care professionals with various areas of expertise who work together toward the goals of their clients) were held on an ongoing basis for two out of five sampled patients (Patients 4 and 5) The cumulative effect of this deficient practice resulted in the failure of the HHA to deliver statutorily mandated compliance of the Federal regulations for Skilled Professional Services to ensure provision of highest quality patient care and services. a. A review of Patient 4's clinical record indicated a referral date of 8/4/2023 and a start of care (SOC) date of 8/10/2023, with a diagnosis of unspecified multiple injuries. A review of the Patient 4's electronic medical record dated 8/10/2023 to 10/28/2023, indicated there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR- allows the electronic entry, storage, and maintenance of digital medical data. EMR contains the patient's records). A review of the Patient 4's electronic medical record dated 10/9/2023 to 12/7/2023, revealed there was no documented recertification assessment for the second benefit period completed in the electronic medical record. There was no documented case summary for this certification periods. A review of the “History of IDT Meetings” on the EMR for Patient 4 revealed no documented evidence of any IDT meetings in the EMR. b. A review of Patient 5's electronic medical record indicated a referral date of 7/26/2023 and a start of care date of 8/2/2023, with a diagnosis of autistic disorder (a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave) and epilepsy (seizure disorders -a brain condition that a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. A review of the Patient 5's electronic medical record dated 8/2/2023 to 9/30/2023, indicated there was no documented initial assessment for this first benefit period completed in the electronic medical record (EMR). A review of the Patient 5's electronic medical record dated 10/1/2023 to 11/29/2023 and 11/30/2023 to 1/28/2024 indicated there was no documented recertification assessment for the second and third benefit period completed in the electronic medical record. There was no documented case summary for this certification periods. A review of the “History of IDT Meetings” on the EMR for this patient revealed no documented evidence of any IDT meetings on EMR. During an interview with the Director of Nursing/Administrator (DON/Admin) on 12/8/2023 at 1:00 p.m., stated the people involved in the case summary are the Registered Nurse (RN), Licensed Vocational Nurse (LVN), Home health aide (HHA), Administrator/Director of Nursing (Admin/DON), Social Worker (SW), or any ancillary personnel, and the Medical Director (MD). The Admin/DON stated we all come to the office or through phone to conduct our case conferences. The Admin/DON confirmed that she could not find the documentation on her computer for the Case Summary Meetings.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency(HHA) failed to ensure supervisory registered nurse(RN) visits were conducted for three out of six sample patients (Patient 1, Patient 2, Patient 3). This failure had the potential to result in patients to not receive adequate nursing care from the licensed vocational nurse(LVN). 1. A review of Patient 1’s facesheet indicated a start of care date (SOC) of 4/15/2023, with diagnoses of cerebral palsy (a congenital disorder of movement, muscle tone, or posture) and legally blind (total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning). A review of Patient 1's physician ordered Licensed Vocational Nurse (LVN) visits for up to 12 hours (hrs) a day for vital sign monitoring, perform skilled assessment and observation of body systems with emphasis on neurological safety and medication administration. Patient 1’s electronic medical record (EMR) was reviewed with the administrator on 12/8/2023, in the HHA’s conference room. No documentation for RN supervisory visits for the LVN could be found. 2. A review of Patient 2’s facesheet indicated a start of care date (SOC) of 2/9/2023, with diagnoses of spastic Quadriplegic cerebral palsy (a severe type that is characterized by paralysis of both arms and both legs, with muscle stiffness). A review of Patient 2's physician ordered Licensed Vocational Nurse (LVN) visits for up to 12 hours (hrs.) a day for vital sign monitoring, perform skilled assessment and observation of body systems with emphasis on Neurological safety and medication administration. Patient 2’s electronic medical record (EMR) was reviewed with the administrator on 12/8/2023, in the HHA’s conference room. No documentation for RN supervisory visits for the LVN could be found. 3. A review of Patient 3’s facesheet indicated a start of care date (SOC) of 6/5/2023, with diagnosis of chronic hepatitis C ( an infection caused by a virus that attacks the liver and causes inflammation which is caused by contact with contaminated blood), and fracture of the lower left leg ( a break or crack in one of the bones in your leg). A review of Patient 3's physician ordered Licensed Vocational Nurse (LVN) visits for up to 12 hours (hrs) a day for assessment of all body systems, vital sign monitoring, observation, teaching and instructions on disease process, diet and medication compliance and perform skilled assessment and observation of body systems. Patient 3’s electronic medical record (EMR) was reviewed with the administrator on 12/8/2023, in the HHA’s conference room. No documentation for RN supervisory visits for the LVN could be found. During an interview and record review with the ADM/ DPCS, on 12/8/2023, at 3pm., of Patient 1, 2 and 3's electronic medical records, the ADM/DPCS stated there was no RN supervisory visits for the LVN’s patient visits documented in their medical records. The ADM/DPCS stated visits should be conducted every 30 days. The documentation would be found under the nurses notes section the medical chart but there was none. The ADM/DPCS stated the RN would fill out a form to confirm that the LVN had provided proper care to the patient. The ADM/DPCS stated that no documentation was found in the patients medical charts and the RN visits were not done. There was no policy and procedure provided when requested by the survey team.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Administrator failed to assume full responsibility for the day-to-day operation of the home health agency (HHA) for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient, 5, Patient 6, and Patient 7). This deficient practice had the potential to result in patients' health care and services will not be met monitored, identified, and resolved that could affect the quality of care provided to the patients by the HHA. On 12/6/2023 through 12/8 2023, a complaint validation survey was conducted. During an interview with the Director of Patient Care Services (DPCS)/Administrator, on 12/6/2023 at10 a.m., the DPCS/ Administrator stated she was everything and does everything for the agency. DPCS/Administrator stated she was working for the agency for five (5) years. When ask for document evidence, she was not able to provide documentation. The DPCS/Administrator was apprised of the findings. No further documented evidence provided.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency failed to have a written agreement or employee file, with the medical director and contract services furnishing services under an arrangement to the home health agency patients. This deficient practice resulted in the HHA's failure to maintain responsibility of the individuals providing services. During the complaint validation survey conducted from 12/6/2023 to 12/8/ 2023, the survey team requested from the Director of Patient Care Services (DPCS)/Administrator the agency contracts with outside services and personnel files for the following: Medical Directors employee file. Physical therapist. Occupational therapist. Speech language pathologist. Durable medical supplies. The DPCS/Administrator was unable to provide the documentations requested.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure Condition of Participation in Clinical Records was met as follows: 1. The HHA failed to ensure the patient's medical records included a skilled nursing note that reflected the care and services provided on visits and was documented, for two out of seven sampled patients (Patient 4 and 5). This deficient practice resulted in the patients' clinical records that were incomplete and had the potential for the needs of the patients were not met. (Refer to G 1010) 2. The HHA failed to ensure the clinical records contained 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 for two of seven sampled patients (Patient 4 and 5). This deficient practice had the potential to result in the continued care, and patient health status to not be coordinated among the staffs providing the care services and had the potential risk of not maintaining the patient's highest level of care. (Refer to G1012) The cumulative effects of these systemic practices resulted in the failure of the agency to deliver statutorily mandated compliance with clinical records.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient's medical records included a skilled nursing note that reflected the care and services provided every visit and was documented, for three out of seven sampled patients (Patien1, 4 and Patient 5), and failed to ensure the address on patient 1's current address was correct on her medical records and patient 1's medication profile was updated for one of seven sampled patients (Patient 1). This deficient practice has the potential for the continued care, and patient health status not be coordinated among the staff providing the care services and had the potential the patients not maintaining the highest level of care. a.A review of Patient1’s “Face Sheet”, Indicated a start of care date (SOC) of 4/15/2023, for the certification period of 10/12/2023 t0 12/10/2023, with diagnoses of Cerebral Palsy( A congenital disorder of movement, muscle tone, or posture) and legally blind ( total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning. The physician ordered Licensed Vocational Nurse (LVN) for up to 12 hours (hrs.) a day for vital sign monitoring, perform skilled assessment and observation of body systems with emphasis on Neurological safety and medication administration. A review of patient 1’s visit notes dated 11/8/023, indicated the LVN provided care from 4:15 pm. To 2:00 am. ( 9 hrs., 45 minutes) homebound status, vitals & measurements, pain screening, Body system Screening/Alteration in Status , cardiovascular section, Respiratory section, gastro-intestinal digestive section, elimination section, nutrition section Endocrine section, Genitourinary Reproduction section, Musculoskeletal section, Integumentary-skin section, safety Issues, Fall/Incidence/Occurrence section, Medication Review section were blank. A review of patient 1’s visit notes dated 11/9/023, indicated the LVN provided care from 4:00 pm. To 11:059 pm. ( 7 hrs. and 59 minutes) homebound status, vitals & measurements, pain screening, Body system Screening/Alteration in Status , cardiovascular section, Respiratory section, gastro-intestinal digestive section, elimination section, nutrition section Endocrine section, Genitourinary Reproduction section, Musculoskeletal section, Integumentary-skin section, safety Issues, Fall/Incidence/Occurrence section, Medication Review section were blank. A review of Patient 1’s visit notes dated 11/8/023, indicated the LVN provided care from 4:00 pm. To 2:30 am. (10 hrs. and 30 minute) homebound status, vitals & measurements, pain screening, Body system Screening/Alteration in Status , cardiovascular section, Respiratory section, gastro-intestinal digestive section, elimination section, nutrition section Endocrine section, Genitourinary Reproduction section, Musculoskeletal section, Integumentary-skin section, safety Issues, Fall/Incidence/Occurrence section, Medication Review section were blank. During a home visit conducted on 12/7/2023, at 5:pm, the surveyor arrived at the address listed on Patient 1’s Personal Information sheet and Home Health Certification and Plan of Care form only to be told by the residents this was the wrong address. A call was placed to Patient 1’s family member who stated that was the wrong address documented on the HHA’s forms and that she lived across the street from the address listed. During a concurrent review of the above skilled nurse’s notes with the ADM/DPCS, in the HHA’s conference room on 12/8/2023, at 3pm. she stated the skilled nurse should have documented in the charts a besides the forms in the patients residence. A review of the agency's policy and procedure titled, ” Contents of The Clinical Record, policy No. 5-005.1, undated under policy stipulates, “ A clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient’s problem and needs, justify care, accurately document care provided and results in detail, and facilitate continuity of care among organization and contract personnel.” Review of the same document Under Procedure 1. Indicates. “The following information will be available in the clinical record, as applicable to care and services provided: L. Notes for each services provided, indicating, date, organization personnel and care provided. DD. Current medication profile, including prescription and nonprescription medications, herbal products and home remedies, dose, strength, frequency, route, date and time of administration, and new, changed, or discontinued medication. b. A review of Patient 4's clinical record indicated a start of care (SOC) date of 8/10/2023, with a diagnosis of unspecified multiple injuries. A review of the Patient 4's electronic medical record dated 8/10/2023 to 10/28/2023, revealed no documented evidence of an initial assessment was conducted by the registered nurse for this certification period was completed in the electronic medical record (EMR- allows the electronic entry, storage, and maintenance of digital medical data. EMR contains the patient's records) A review of the Patient 4's electronic medical record dated 10/9/2023 to 12/7/2023, revealed that there was no documented recertification assessment conducted by licensed member of the IDG for this recertification period completed in the electronic medical record. There was no documented home health aid visit notes on 8/11/2023, 8/14/2023 and 8/18/2023. There was no documented evidence in the communication log following up to the assigned nurse to submit their clinical notes in time. c. A review of Patient 5's electronic medical record indicated a start of care date of 8/2/2023, with a diagnosis of autistic disorder (a neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave) and epilepsy ("seizure disorders a brain condition that a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. A review of the Patient 5's electronic medical record dated 8/2/2023 to 9/30/2023, revealed that there was no documented initial assessment conducted by a licensed member of the IDG was completed in the electronic medical record (EMR). A review of the Patient 5's electronic medical record dated 10/1/2023 to 11/29/2023 and 11/30/2023 to 1/28/2024 revealed that there was no documented recertification assessment completed in the electronic medical record. There was no documented case summary for this certification periods. A review of the "History of visit Notes "on the EMR revealed that on 10/18/2023, 10/21/2023, 10/27/2023, 11/3/2023, 11/6/2023, 11/10/2023, 11/13/2023, 11/16/2023 had no written and complete notes from the assigned skilled nurse. A review of the "Communication Log" for this patient indicated no written evidence of their follow up with the assigned nurse to submit their documentations. During an interview with the Director of Nursing/Administrator (DON/Admin) on 12/8/2023, at 1 p.m., stated that the office personnel follows up with the skilled nurses and medical doctors on the timely submission of their documentation. Admin/DON stated they write it in the communication log, send them text messages to follow up with their documentation. On Concurrent review with the Admin/DON confirmed that there were no clinical notes submitted for both Patient 4 and Patient 5 in the EMR. A review of the HHA’s policy titled “Contents of the Clinical Record” revised 4/2020 indicated that a clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient's problems and needs, justify care, accurately document care provided and results in detail, and facilitate continuity of care among organization and contract personnel. A review of the HHA’s policy titled “Initial and Comprehensive Assessment” revised 4/2020 indicated that A plan of care will be developed from the information gathered during the initial and comprehensive assessment. The patient's physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed. 3. Re-assessments should focus on: Patient's response to care, changes in patient condition, changes in patient diagnoses, changes in patient s care environment or support system, when a patient is receiving only personal care and support services, the reassessment will occur at least every six (6) months or more often, as necessary. Based on each reassessment, the plan of care, including problems, needs, goals, and outcomes will be reviewed and revised accordingly by the clinician. Based on the findings of the reassessment, change/verbal orders will be generated and forwarded to the physician (or another authorized licensed independent practitioner) as needed. The physician will be notified to verify any changes in medications, including over-the-counter medications (which might interact or be duplicative with other patient medications), and treatment/interventions that require physician approval. The organization shall communicate with all physicians involved in the plan of care to avoid duplication or contradictory physician orders and to assure that all patient needs are being met. All physician orders shall be integrated into the plan of care. The plan of care is reviewed and signed by the physician responsible for the plan of care.

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 observation , record review and interview, the HHA failed to ensure the clinical record of one of seven sampled patients (Patient 1) had the current and most recent patient address, and ensure that the Licensed vocational Nurses notes were completed and the medication profile of patient 1’s current medications were updated. These deficient practices had the potential to result in the continued care, and patient health status to not be coordinated among the staffs providing the care services and had the potential risk of not maintaining the patient's highest level of care. A review of Patient 1’s facesheet indicated a start of care date (SOC) of 4/15/2023, for the certification period of 10/12/2023 to 12/10/2023, with diagnoses that included cerebral palsy(a congenital disorder of movement, muscle tone, or posture) and legally blind (total blindness or those that can see with limitations that severely impact mobility, employment, and normal daily functioning). The physician ordered Licensed Vocational Nurse (LVN) visits for up to 12 hours (hrs) a day for vital sign monitoring, to perform skilled assessment and observation of body systems with emphasis on neurological safety and medication administration. A review of patient 1’s visit notes dated 11/8/023, indicated the LVN provided care from 4:15 pm. to 2 am. (9 hrs., 45 minutes) However, the visit notes indicated the following sections were blank: Homebound status. Vitals & measurements. Pain screening. Body system screening/alteration in status. Cardiovascular section. Respiratory section. Gastrointestinal digestive section. Elimination section. Nutrition section. Endocrine section. Genitourinary Reproduction section. Musculoskeletal section. Integumentary-skin section. Safety Issues. Fall/Incidence/Occurrence section. Medication Review. A review of patient 1’s visit notes dated 11/9/023, indicated the LVN provided care from 4 pm. to 11:59 pm. (7 hrs. and 59 minutes). However, the visit notes indicated the following sections were blank: Homebound status. Vitals & measurements. Pain screening. Body system Screening/Alteration in Status. Cardiovascular section. Respiratory section. Gastrointestinal digestive section. Elimination section. Nutrition section. Endocrine section. Genitourinary Reproduction section. Musculoskeletal section. Integumentary-skin section. Safety Issues. Fall/Incidence/Occurrence section. Medication Review section. A review of Patient 1’s visit notes dated 11/8/023, indicated the LVN provided care from 4 pm. to 2:30 am. (10 hrs. and 30 minute) However, the visit notes indicated the following sections were blank: Homebound status. Vitals & measurements. Pain screening. Body system Screening/Alteration in Status. Cardiovascular section. Respiratory section. Gastrointestinal digestive section. Elimination section. Nutrition section. Endocrine section. Genitourinary Reproduction section. Musculoskeletal section. Integumentary-skin section. safety Issues. Fall/Incidence/Occurrence section. Medication Review. During a home visit conducted on 12/7/2023, at 5 pm. the surveyor arrived at the address listed on Patient 1’s Personal Information sheet and Home Health Certification and Plan of Care form only to be told by the residents this was the wrong address. A call was placed to Patient 1’s family member who stated that was the wrong address documented on the HHA’s forms and that she lived across the street from the address listed. During a concurrent review of the above skilled nurses notes with the ADM/DPCS, in the HHA’s conference room on 12/8/2023, at 3 pm. she stated the skilled nurse should have documented in the chart besides the forms in the patients residence. A review of the agency's undated policy and procedure "Contents of the Clinical Record, policy No. 5-005.1, under policy stipulates, “A clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient’s problem and needs, justify care, accurately document care provided and results in detail, and facilitate continuity of care among organization and contract personnel.” A review of the same document under procedure 1 indicated “The following information will be available in the clinical record, as applicable to care and services provided: L. Notes for each services provided, indicating, date, organization personnel and care provided. DD. Current medication profile, including prescription and nonprescription medications, herbal products and home remedies, dose, strength, frequency, route, date and time of administration, and new, changed, or discontinued medication.