Every finding on record at Valeri Home Health, Inc.

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey conducted from 5/14/2024 to 5/17/2024. Complaint Number: 105662. Representing the Department of Public Health: Surveyor ID # 43979 -RN - HFEN Surveyor ID # 43929 -RN – HFEN Census: 24 Unduplicated admissions:56 Sample Size: 7 Home Visits: 2 Closed Record review: 2 The following Conditions of Participation (COP) were not met: 484.60 Care Planning, Coordination of Services, and Quality of Care 484.110 Clinical Records

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 home health agency (HHA) failed to provide services as indicated in the plan of care for one of seven sampled patients (Patient 2). This deficient practice has the potential to affect the quality of care provided to the patients and can result in delayed healing due to missed treatments. A review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 3/22/2204 to 5/20/2024, indicated a start of care date on 9/24/2023, with a primary diagnosis of bilateral primary osteoarthritis of knee (both knees are stiff and painful). The record further indicated Patient 2 was to receive Physical Therapy (PT) evaluation and treatment. During an interview on 5/15/2024, at 12:50 p.m., the Administrator/Director of Nurses (ADM/DON), stated Patient 2 was supposed to be seen by PT once a week for 9 weeks. The ADM/DON stated Patient 2 had three missed visits (4/2/2024, 4/9/2024, and 4/26/2024). The ADM/DON stated he had just found out now about the missed visits. The ADM/DON stated the office staff (OS 1) was the PT coordinator and she was supposed to follow up and communicate with him. The ADM/DON stated the patient had a risk of not reaching the maximum benefit and goals because of missed visits from PT services. During an interview on 5/15/2024, at 1:30 p.m., Patient 2 stated he did not know why PT services stopped coming to his home 2 weeks ago. Patient 2 stated he was really upset that he now had to go get PT services outside his home. Patient 2 stated he did not know what happened but either the doctor or the adult day care center sent him to get PT at a location outside his home. A record review of the HHA’s policy and procedure titled, “Patient Bill of Rights”, dated November 20221, indicated, “Procedure…2. The Patient Bill of Rights statement defines the right of the patient to…G…The organization shall ensure that the patient receives all services outlined in the plan of care.”

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the doctor was aware that the patient goals were met, and the patient should be discharged, for one of seven sampled patients (Patient 7). This deficient practice resulted in discharging the patient from the HHA without consulting with the doctor to determine if the discharge was appropriate. During a review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 2/22/2204 to 4/21/2024, indicated a start of care date on 10/25/2023, with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 7’s Electronic Medical Record (EMR), the EMR indicated Patient 7 was discharged from the HHA on 4/19/2024. the EMR also indicated Patient 7’s discharge order was created on 5/14/2024 by the Administrator / Director of Nurses (ADM/DON). During a review of Patient 7’s Electronic Medical Record (EMR), medical record titled “OASIS-E Discharge” indicated Patient 7 was discharged from the HHA on 4/19/2024. The OASIS-E Discharge also indicated Patient 7’s discharge nursing assessment was created on 5/14/2024 by the ADM/DON. During an interview on 5/17/2024 at 11:38 a.m. with the ADM/DON, the ADM/DON stated Patient 7’s medical doctor was verbally notified when Patient 7 was discharged. The ADM/DON stated nothing was documented to indicated Patient 7’s doctor was made aware of Patient 7’s discharge. The ADM/DON stated the doctor needed to know the patient was discharged and was no longer receiving HHA services to follow up. The ADM/DON stated doctors also need to know if the discharge patient has met their goals. A record review of the HHA’s policy and procedure titled, “Discharge Summary”, dated November 2021, indicated, “Procedure 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include as appropriate…C. The date of discharge, the date the physician and patient informed of discharged. D. The reason for discharge.”

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 document all of the current medications and treatments for one of 7 sampled patients (Patient 1). This failure placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. A review of Patient 1’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/4/2024 to 6/2/2024, indicated start of care on 4/4/2024, with a primary diagnosis of hypertensive heart disease without heart failure (high blood pressure). During a concurrent observation, interview, and record review, during the home visit, on 5/16/2024, at 10:10 a.m., the Administrator/Director of Nurses (ADM/DON) reviewed the medications Patient 1 was taking, using Patient 1’s record titled, “Medication Profile”, dated 4/30/2024 to 6/28/2024. The ADM/DON stated Patient 1 was taking the following medications: Medication “Zofran” (for nausea) was listed in the profile but not at the home. Medication “Pantoprazole Sodium” was to be taken one tablet by mouth twice a day before meals as indicated in the label. The medication profile indicated to take once a day. The ADM/DON stated the frequency listed on the medication profile was incorrect. Medication “Vitamin D3” (a supplement) dosage was listed incorrectly in the medication profile. The patient was taking 5,000 iu (iu-international units, unit of measurement). The medication profile had 2000 iu listed. Patient 1 stated she had been taking this medication for years. Medication “Senna Plus” (stool softener), two tablets as needed according to the instructions on the packet. This medication was not listed in the medication profile. Medication “Iron 45 mg” (supplement) one tablet daily. This medication was not listed in the medication profile. During continued observation, interview, and record review on 5/16/2024, at 10:35 a.m., the ADM/DON reviewed the medications Patient 1 was taking at home using her record titled, “Medication Profile”, dated 4/30/2024 to 6/28/2024. Patient 1 had two medication dosages of “hydralazine” (for blood pressure). One dosage indicated “Hydralazine 25 mg tablet. Give one tablet by mouth every six hours as needed for SBP>160” (for systolic blood pressure greater than 160). This dosage was also listed in the medication profile. The second dosage indicated, “Hydralazine 50 mg tablets. Take 1 tablet by mouth three times a day”. The ADM/DON stated to Patient 1 not to take the medication until he called the pharmacy and doctor to clarify which medications should be taken. The ADM/DON stated to Patient 1 he would not set up her medication on today’s visit until all the medications would be verified. The ADM/DON stated he would visit the patient again this week after her verifies and clarifies with the pharmacy and doctors which medications Patient 1 should be taking. During an interview on 5/15/2024 at 1:42 p.m. with the ADM/DON, the ADM/DON stated medication reconciliations are done at every visit to reflect changes in their medication which can pose a risk to patients’ safety. During an interview on 5/16/2024, at 11:10 a.m., the ADM/DON stated medication review is to be done every visit. The nurse is required to bring all the medication bottles, check the label, using the medication profile, to make sure it is accurate. If there is a discrepancy, the nurse is supposed to call the doctor, at the patient’s home, to clarify which medication/dosage/frequency the patient is ordered to take. The reason we want the nurse to do it at the home is so the nurse can instruct the patient how to take the medication. If for some reason, the nurse cannot contact the doctor, the nurse is required to contact me or the case manager so we could help follow up, get an order, and update the medication profile. All this is to occur on the same day. A record review of the HHA’s policy and procedure titled, “Medication Profile”, dated November 2021, indicated, “Policy…Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications.”

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 regarding Care Planning, Coordination, Quality of Care was met as follows: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The HHA failed to ensure two of seven sampled patients (Patient 1 and Patient 2) received services according to their plan of care (POC). This failure had the potential to result in a health status decline and risk of hospitalization by failing to ensure the needs of the patients were met. (Refer to G572). 2. The HHA failed to ensure the physician's medical orders were signed and dated by the physician for three of seven sampled patients (Patient 2, Patient 3, and Patient 5). This failure resulted the HHA providing services without the doctor validating the services the patient was supposed to receive. (Refer to G584). 3.The HHA failed to ensure the Plan of Care (POC) was reviewed and signed by a physician for three of seven sampled patients (Patient 2, Patient 3, and Patient 5). This failure resulted in the physician not being aware of the services being provided or not provided to the patient by the HHA. This failure had the potential to result in delay in care and services and a delay in healing that could lead to hospitalization and/or death. (Refer to G588). 4. The HHA failed to ensure a plan of care was developed for one of seven sampled patients (Patient 3). This failure resulted in patients receiving services from the HHA without an individualized plan of care. (Refer to G592). 5. The HHA failed to inform one of seven sample patients (Patient 7) medical doctor when he was no longer receiving HHA services due to being discharged. This failure had the potential to result in placing Patient 7 at risk of not receiving follow up by his doctor, which can lead to hospitalization. (Refer to G598) 6. The HHA failed to communicate with one of seven sample patients (Patient 7) medical doctors when Patient 7 was discharged and no longer receiving HHA services. This failure had the potential to place Patient 7 at risk of not receiving the follow up services to prevent re-enlistment at an HHA or hospitalization. (Refer to G602). 7. The HHA failed to provide written information regarding the plan of care for one of seven sampled patients (Patient 1) This deficient practice resulted in patients and their representatives not knowing their care team or that their treatment course were ordered. (Refer to G612). 8. The HHA failed to provide written information regarding the medication list for one of seven sampled patients (Patient 1). This deficient practice resulted in patients and their representatives not knowing their care team or that their treatment course were ordered. (Refer to G616). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure the highest quality health care is provided to patients assessed to receive home health 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 interview, and record review, the home health agency (HHA) failed to ensure two of seven sampled patients (Patient 1 and Patient 2) received services according to their plan of care (POC). This failure had the potential to result in health status decline and risk of hospitalization to ensure the needs of the patients are met. 1 A review of Patient 1’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/4/2024 to 6/2/2024, indicated a start of care on 4/4/2024, with a primary diagnosis of hypertensive heart disease without heart failure (high blood pressure). During an interview at the home visit on 5/16/2024, at 10:05 a.m., Patient 1 stated she had requested for the home health aide not to come because she did not have hot water due to the water heater being broken. Patient 1 stated she did not have hot water since 5/10/2024. During an interview on 5/16/2024, at 2:05 p.m., Licensed Vocational Nurse 1 (LVN 1) stated she visited Patient 1 on 5/15/2024. LVN 1 stated Patient 1 informed her of not having hot water on 5/15/2024 but did not inform the HHA about it because it was in the process of resolving. During a concurrent interview and record review on 5/16/2024, at 2:13 p.m., the Administrator and Director of Nurses (ADM/DON), reviewed Patient 1’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/4/2024 to 6/2/2024. The record indicated, “Instructed on safe utilities management” and “SN (skilled nurse) to develop individualized emergency plan with patient”. The ADM/DON stated the statements forementioned meant it had to do with assistive devices, the phrases came from the OASIS (a start of care assessment) and did not know what it pertained to. The ADM/DON stated utilities at home were gas, water, and electricity. During an interview on 5/16/2024, at 2:16 p.m., the ADM/DON stated he knew about Patient 1 not having hot water on 5/14/2024, when he tried to arrange for a home visit. The ADM/DON stated he did not do anything about it because Patient 1 told him she was going to get it fixed. When asked what the HHA’s responsibility was when patient reports not having hot water was, the ADM/DON stated he did not know the answer to that. The ADM/DON stated if patient was neglected or anything involved with safety, the social worker needs to assess to see if patient is able to meet her needs, such as activities of daily living (ADL). During an interview on 5/17/2024, at 11:32 a.m., the ADM/DON stated interventions should have begun when the HHA was aware of Patient 1 not having hot water, on 5/14/23. The ADM/DON stated the HHA did not do interventions because patient had verbalized that she was getting the water heater fixed. The ADM/DON stated agency should have followed up to make sure issue had been fixed and assess if further agency interventions were needed. A record review of the HA’s (Hospice Agency), policy and procedure titled, “Ongoing Assessments”, indicated, “Procedure…2. Using the standards of care identified by the organization, the clinical will reassess the patient for…J. Safety/home environment…3. Re-assessment should focus on…D. Changes in patient’s care environment or support systems…5. Based on each reassessment, the plan of care, including problems, needs, goals, and outcomes will be reviewed and revised accordingly by the clinician.” 2. A review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 3/22/2204 to 5/20/2024, indicated a start of care date on 9/24/2023, with a primary diagnosis of bilateral primary osteoarthritis of knee (both knees are stiff and painful). The record further indicated Patient 2 was to receive Physical Therapy (PT) evaluation and treatment. During an interview on 5/15/2024, at 12:48 p.m., the Administrator/Director of Nurses (ADM/DON) stated the PT evaluation was supposed to be done within 48 hours of the start of the next episode. The ADM/DON stated Patient 2 was seen on 3/29/2024, 7 days after the start of the care episode and did not know why the visit was late. by PT once a week for 9 weeks. The ADM/DON stated Patient 2 had three missed visits (4/2/2024, 4/9/2024, and 4/26/2024). The ADM/DON stated he had just found out now about the missed visits. The ADM/DON stated the office staff (OS 1) was the PT coordinator and she was supposed to follow up and communicate with him. The ADM/DON stated for missed visits, the doctor was supposed to be notified immediately, an attempt to reschedule should have occurred, try to see what the problem was, and try to identify what the issue was. The ADM/DON stated the doctor was not notified because he just found out about the missed visits today. The ADM/DON stated the patient has a risk of not reaching the maximum benefit and goals as a result of missed visits from PT services. During an interview on 5/15/2024, at 1:30 p.m., Patient 2 stated he did not know why PT services stopped coming to his home 2 weeks ago. Patient 2 stated he was really upset that he now had to go get PT services outside his home. Patient 2 stated he did not know what happened but either the doctor or the adult day care center sent him to get PT at a location outside his home. A record review of the HHA’s policy and procedure titled, “Patient Bill of Rights”, dated November 20221, indicated, “Procedure…G…The organization shall ensure that the patient receives all services outlined in the plan of care.” A record review of the HHA’s policy and procedure titled, “Care/Service Coordination”, dated November 2021, indicated, “Procedure…Care coordination will include, but not be limited to…I. Integration of services, whether services are provided directly or under arrangement, to assure identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines...7. When the patient requires more than one (1) service from the organization, the Case Manager will be responsible for cooperative care planning in order to assure that goals, actions, and the interrelationship of services is not duplicated and to minimize the potential for missed or conflicting services.”

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the physician's medical orders were signed and dated by the physician for three of seven sampled patients (Patient 2, Patient 3, and Patient 5). This failure resulted the HHA providing services without the doctor validating the services the patient was supposed to receive. 1. A review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 3/22/2204 to 5/20/2024, indicated a start of care date on 9/24/2023, with a primary diagnosis of bilateral primary osteoarthritis of knee (both knees are stiff and painful). A record review of Patient 2’s record titled, “Recertification Order”, dated 1/19/2024, indicated this order was to recertify Patient 2 for certification period 1/22/2204 to 3/21/2024. Further review of the record did not indicate the doctor had signed the order. A record review of Patient 2’s record titled, “Recertification Order”, dated 3/21/2024, indicated this order was to recertify Patient 2 for certification period 3/22/2024 to 5/20/2024. Further review of the record did not indicate the doctor had signed the order. 2 A review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/10/2024 to 6/8/2024, indicated a start of care on 12/12/2023, with a primary diagnosis of Vitamin B12 deficiency anemia (body lacking a nutrient needed). During a concurrent interview and record review on 5/15/2024, at 11:01 a.m., the Administrator/Director of Nurses (ADM/DON) reviewed Patient 3’s record titled, “Recertification Order”, dated 4/6/2024. The record indicated this order was to recertify Patient 3 for certification period 4/10/2024 to 6/8/2024. The ADM/DON stated the record had not been signed by the doctor. The ADM/DON stated the doctor should have signed the order by the end of the month. It was important for the doctor to sign the order to validate the services being provided, so the doctor knows about the plan of care and was in agreement with it. The ADM/DON stated he did not know when the order was sent to the doctor. During an interview on 5/15/2024 at 11:09 a.m., the ADM/DON stated he had checked all the files and the HHA did not have any signed orders from the doctor for Patient 3. A record review of Patient 3’s record titled, “Recertification Order”, dated 2/7/2024, indicated this order was to recertify Patient 3 for certification period 2/10/2024 to 4/9/2024. Further review of the record did not indicate the doctor had signed the order. 3. During a review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 3/1/2204 to 4/29/2024, indicated a start of care date on 3/1/2024, with a primary diagnosis of monoplegia of upper limb following unspecified cerebrovascular disease affecting the right dominant side (right upper arm paralysis). During a concurrent interview and record review on 5/15/2024 at 10 a.m. with License Vocational Nurse 2 (LVN2) of Patient 5’s Electronic Medical Record (EMR), LVN2 stated she did not know when Patient 5’s current medical record titled “Home Health Certification and Plan of Care” was created. LVN2 stated the HHA did not have a signed plan of care for Patient 5 dated 3/1/2024 to 4/29/2024. During an interview on 5/15/2024 at 10:50 a.m. with LVN2, LVN2 stated it was important for the medical doctor to sign patients plans of care because their signature indicates the form is correct. LVN2 stated patients plans of care are the medical doctors’ orders. A record review of the HHA’s policy and procedure titled, “Reassessments/Recertifications”, dated November 2021, indicated, “Procedure…10. The physician (doctor)…will be contacted to verify the continued need for care and his/her agreement with the continued plan of care. 11. An interim order to continue home care services will be prepared and sent to the physician.” A record review of the HHA’s policy and procedure titled, “Verification of Physician Orders”, dated November 2021, indicated, “Procedure…8. Signed orders will be in the clinical record within 30 days of initiation of care…”.

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 home health agency (HHA) failed to ensure the Plan of Care (POC) was reviewed and signed by a physician for three of seven sampled patients (Patient 2, Patient 3, and Patient 5). This failure resulted in the physician not being aware of the services being provided or not provided to the patient by the HHA. This failure had the potential to result in a delay in care and services and a delay in healing that could lead to hospitalization and/or death. 1. A review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 3/22/2204 to 5/20/2024, indicated a start of care date of 9/24/2023, with a primary diagnosis of bilateral primary osteoarthritis of the knees (both knees are stiff and painful). A record review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/24/2023 to 11/22/2023, did not indicate the doctor had signed the POC. A record review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 1/22/2024 to 3/21/2024, did not indicate the doctor had signed the POC. 2. A review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/10/2024 to 6/8/2024, indicated a start of care on 12/12/2023, with a primary diagnosis of Vitamin B12 deficiency anemia (body lacking a nutrient needed). A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 12/12/2023 to 2/9/2024, did not indicate the doctor had signed the POC. A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 2/10/2024 to 4/9/2024, did not indicate the doctor had signed the POC. 3. During a review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, f or certification period 3/1/2204 to 4/29/2024, indicated a start of care date of 3/1/2024, with a primary diagnosis of monoplegia of the upper limb following unspecified cerebrovascular disease affecting the right dominant side (right upper arm paralysis). During a concurrent interview and record review on 5/15/2024 at 10 a.m. with License Vocational Nurse 2 (LVN2) of Patient 5’s Electronic Medical Record (EMR), LVN2 stated she did not know when Patient 5’s current medical record titled “Home Health Certification and Plan of Care” was created. LVN2 stated the HHA did not have a signed plan of care for Patient 5 dated 3/1/2024 to 4/29/2024. During an interview on 5/15/2024 at 10:50 a.m. with LVN2, LVN2 stated it was important for the medical doctor to sign patients plans of care because their signature indicates the form is correct. LVN2 stated patients plans of care are the medical doctors’ orders. A review of the HHA’s policy and procedure titled, “Reassessments/Recertifications”, dated November 2021, indicated, “Procedure…12. The updated plan of care will be prepared and sent to the physician (doctor) for review and signature in a timely manner.”

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient 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 a plan of care was developed for one of seven sampled patients (Patient 3). This failure resulted in patients receiving services from the HHA without an individualized plan of care. A review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/10/2024 to 6/8/2024, indicated a start of care on 12/12/2023, with a primary diagnosis of Vitamin B12 deficiency anemia (body lacking a nutrient needed). During a concurrent interview and record review on 5/14/2024, at 2 p.m., the Office Staff 1 (OS 1), reviewed Patient 3’s electronic medical records (EMR) and stated the plan of care (POC) was not done yet. During a record review of Patient 3’s document titled, on 5/14/2024, “Episode Manager: View Orders”, dated 4/10/2024 to 6/8/2024, indicated “Task 1. CMS 485 (POC) …target date…4/10/24…status, not started”. During an interview on 5/24/2024 at 2:24 p.m., the Administrator and Director of Nurses (ADM/DON), stated the POC was done, but it had not been signed. The ADM/DON stated if the document was not signed, technically it was not completed. During a concurrent interview and record review on 5/15/2024, at 10:50 a.m., the HHA’s electronic medical record representative (EMR Rep) reviewed Patient 3’s record titled, “Task Details” (a document that indicates all the entries, modifications, deletions, made to the EMR). The record indicated the POC was “task created” on April 30, 2024. The EMR Rep stated “task created” meant that the POC was added to the record as a task, which meant that there was no documentation on the record. The EMR Rep stated “not started status meant nothing was documented on the record. Further review of the record indicated, “completed” on “May 14, 2024, at 17:03 (5:03 p.m.). The EMR Rep stated “completed” meant the POC was complete and approved. On 5/15/2024, at 10:19 a.m., the ADM/DON provided a POC for Patient 3. During an interview on 5/16/2024, at 1:15 p.m., the ADM/DON stated the purpose of a POC was to assist patients, providing instructions through assessment of nurses, related to all the health conditions of the patient and what we can do to optimize their health, to prevent hospitalizations. To optimize safety and prevent hospitalizations. During an interview on 5/16/2024, at 1:16 p.m., the ADM/DON stated the POC was supposed to be done within five days of when the assessment was completed. If the patient was re-certified for HHA services, the POC should have been completed within three days from the assessment. Without it, the HHA should not be seeing the patients. The importance of having a POC is for the nurses to know what care to provide. There are guidelines on what to do. Basically, it is following a plan for all the disciplines. The POC needed to be completed before any nursing visits. A review of Patient 3’s document titled, “OASIS-E Recertification”, dated 4/6/2024, indicated the recertification assessment was done on this date. Further review of the record indicated the patient was to receive skilled nursing services twice a week for the first week, then once a week for eight weeks. The home health aide was to visit the patient once a week for eight weeks. A record review of the HHA’s policy and procedure titled, “Care Planning Process”, dated November 2021, indicated, “Policy: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient’s condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient.”

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to inform one of seven sample patients (Patient 7) medical doctor when he was no longer receiving HHA services due to being discharged. This failure had the potential to result in placing Patient 7 at risk of not being followed up on which can lead to hospitalization. During a review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care”, for the certification period of 2/22/2204 to 4/21/2024, indicated a start of care date on 10/25/2023, with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 7’s Electronic Medical Record (EMR), the EMR indicated Patient 7 was discharged from the HHA on 4/19/2024. It also indicated Patient 7’s discharge order was created on 5/14/2024 by the Administrator / Director of Nurses (ADM/DON). During a review of Patient 7’s Electronic Medical Record (EMR), medical record titled “OASIS-E Discharge” indicated Patient 7 was discharged from the HHA on 4/19/2024. It also indicated Patient 7’s discharge nursing assessment was created on 5/14/2024 by the ADM/DON. During an interview on 5/17/2024 at 11:38 a.m. with the ADM/DON, the ADM/DON stated Patient 7’s medical doctor was verbally notified when Patient 7 was discharged. The ADM/DON stated nothing was documented to indicated Patient 7’s doctor was made aware of Patient 7’s discharge. The ADM/DON stated the doctor needed to know the patient was discharged and no longer receiving HHA services to follow up. The ADM/DON stated doctors also need to know if the discharge patient has met their goals. A record review of the HHA’s policy and procedure titled, “Discharge Summary”, dated November 2021, indicated, “Procedure 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include as appropriate…C. The date of discharge, the date the physician and patient informed of discharged. D. The reason for discharge.”

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 one of seven sample patients (Patient 7) medical doctor was made aware when Patient 7 was discharged and no longer receiving HHA services. This failure had the potential to place Patient 7 at risk of not receiving the follow up services to prevent re-enlistment at an HHA or hospitalization. During a review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 2/22/2204 to 4/21/2024, indicated a start of care date on 10/25/2023, with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 7’s Electronic Medical Record (EMR), the EMR indicated Patient 7 was discharged from the HHA on 4/19/2024. It also indicated Patient 7’s discharge order was created on 5/14/2024 by the Administrator /Director of Nurses (ADM/DON). During a review of Patient 7’s Electronic Medical Record (EMR), medical record titled “OASIS-E Discharge” indicated Patient 7 was discharged from the HHA on 4/19/2024. It also indicated Patient 7’s discharge nursing assessment was created on 5/14/2024 by the ADM/DON. During an interview on 5/17/2024 at 11:38 a.m. with the ADM/DON, the ADM/DON stated Patient 7’s medical doctor was verbally notified when Patient 7 was discharged. The ADM/DON stated nothing was documented to indicate Patient 7’s doctor was made aware of Patient 7’s discharge. The ADM/DON stated the doctor needed to know the patient was discharged and no longer receiving HHA services to follow up. The ADM/DON stated doctors also need to know if the discharge patient has met their goals. A record review of the HHA’s policy and procedure titled, “Discharge Summary”, dated November 2021, indicated, “Procedure 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include as appropriate…C. The date of discharge, the date the physician and patient informed of discharged. D. The reason for discharge.”

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to provide written information regarding the plan of care (POC) for one of seven sampled patients (Patient 1). This deficient practice resulted in patients and their representatives not knowing their care team or their treatment course were ordered. A review of Patient 1’s record titled, “Home Health Certification and Plan of Care”, for the certification period of 4/4/2024 to 6/2/2024, indicated a start of care on 4/4/2024, with a primary diagnosis of hypertensive heart disease without heart failure (high blood pressure). During a concurrent interview and record review, during the home visit on 5/16/2024, at 10:52 a.m., the Administrator and Director of Nurses (ADM/DON), reviewed the agency folder at home (a folder that is given at the start of care, containing written information). The ADM/DON stated there was no POC in the folder. The ADM/DON stated he had brought a copy of the POC and placed it in the folder during this visit. The ADM/DON stated it was supposed to be provided as soon as it was completed, ideally, the next visit from the start of care. A review of the HHA’s policy and procedure titled, “Care Planning Process”, dated November 2021, indicated, “Procedure…17. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including the day of the week, frequency of visits by personnel and personnel acting on behalf of the organization…D. Any other pertinent instruction related to the patient’s care and treatments that the organization will provide, specific to the patient’s care needs.”

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to provide written information regarding the medication list for one of seven sampled patients (Patient 1). This deficient practice resulted in patients and their representatives not knowing their care team or their ordered treatment course. A review of Patient 1’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/4/2024 to 6/2/2024, indicated a start of care on 4/4/2024, with a primary diagnosis of hypertensive heart disease without heart failure (high blood pressure). During a concurrent interview and record review, during the home visit on 5/16/2024, at 10:52 a.m., the Administrator and Director of Nurses (ADM/DON), reviewed the agency folder at home (a folder that is given at the start of care, containing written information). The ADM/DON stated there was no medication list from the current visit. The ADM/DON stated there was a medication list inside the folder but that was from the previous episode. A review of the HHA’s policy and procedure titled, “Care Planning Process”, dated November 2021, indicated, “Procedure…17. The organization shall provide the patient and caregiver with a copy of written instructions outlining…B. Patient medication schedule/instructions, including medication name, dosage, and frequency…”.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the administrator had evidence that staff employed at the HHA were qualified to care for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This failure had the potential to result in patients being taken care of by unqualified and unlicensed staff which potentially can result in harm and injury to patients. A review of Patient 1’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/4/2024 to 6/2/2024, indicated a start of care on 4/4/2024, with a primary diagnosis of hypertensive heart disease without heart failure (high blood pressure). A review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 3/22/2204 to 5/20/2024, indicated a start of care date on 9/24/2023, with a primary diagnosis of bilateral primary osteoarthritis of knee (both knees are stiff and painful). A review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/10/2024 to 6/8/2024, indicated a start of care on 12/12/2023, with a primary diagnosis of Vitamin B12 deficiency anemia (body lacking a nutrient needed). A review of Patient 4’s record titled, “Patient Information”, indicated a start of care of 9/3/2023, with a primary diagnosis of primary osteoarthritis, left shoulder (stiffening and pain of the joint). During a review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 3/1/2204 to 4/29/2024, indicated a start of care date on 3/1/2024, with a primary diagnosis of monoplegia of upper limb following unspecified cerebrovascular disease affecting the right dominant side (right upper arm paralysis). During a review of Patient 6’s medical record titled “Patient Information” indicated a start of care date of 4/6/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 2/22/2204 to 4/21/2024, indicated a start of care date on 10/25/2023, with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a concurrent interview and record review on 5/16/2024 at 12:57 p.m. with Human Resources (HR) of employee records, HR stated Licensed Vocational Nurse 3 (LVN3) and Certified Home Health Aide 1 (CHHA1) employment applications were not complete. HR stated a completed employment application was needed to verify if the person qualifies for the position. HR stated patients are at risk of dying, getting the wrong medications, or risk of harm because HR did not know if these employees were qualified. HR stated CHHA2 basic life support (BLS) certification was not up to date and that there was no evidence CHHA2 was oriented to the HHA. HR stated CHHA2’s BLSs certificate expired on 2/2024. HR stated it was important for employees to have current BLS certification to be aware that they are able to perform basic life support. HR stated this placed patients at great risk. HR stated it was important for all employees to be oriented to the HHA so they can know the HHAs mission, regulations, and policies and procedures. Lastly, HR stated Employee 1 (EMP1) was a Registered Nurse but did not have documented evidence in her employee file. HR stated it was important to have a current license on file to ensure their credentials. HR stated patient were at risk of receiving wrong medications or at risk of being harmed and dying. A review of the HHA’s policy and procedure titled, “Personnel Record Contents”, dated November 2021, indicated, “Procedure 1. The content of the personnel files for regular full part-time personnel will include…General documents…C. Verified professional licensure or certification/aide registry…New Hire documents…B. Individual job qualifications…C. Employment application…H. Verification of education/training…J. Orientation checklist…J. Orientation checklist (completed)…O. Criminal background check…Per Diem and Contract…Direct Care Documents…C. Verified professional licensure or certification…New Hire Documents…A. Employment application, if applicable. D. Orientation checklist (completed)…G. Criminal background check…”

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 interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Clinical Records was met as follows: 1.The HHA failed to ensure four of seven sampled patients (Patient 2, Patient 5, Patient 6, and Patient 7) clinical records were complete to include the patients plans of care and Physical Therapy (PT) notes. This failure resulted in an incomplete clinical record. (Refer to G1012). 2. The HHA failed to send all necessary medical information to the primary care practitioner within five days of discharge for one of seven sampled patients (Patient 7). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. (Refer G1022). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.

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 interview and record review the Home Health Agency (HHA) failed to ensure four of seven sampled patients (Patient 2, Patient 5, Patient 6, and Patient 7) clinical records were complete to include patients plans of care and Physical Therapy (PT) notes. This failure resulted in an incomplete clinical record. 1. A review of Patient 2’s record titled, “Home Health Certification and Plan of Care”f or certification period 3/22/2204 to 5/20/2024, indicated a start of care date on 9/24/2023, with a primary diagnosis of bilateral primary osteoarthritis of knee (both knees are stiff and painful). The record further indicated Patient 2 was to receive PT services. During a concurrent interview and record review on 5/15/2024, at 12:15 p.m., the Administrator/Director of Nurses (ADM/DON) reviewed Patient 2’s electronic medical record (EMR) and stated the PT notes were not in the record. During an interview on 5/15/2024, at 12:18 p.m., the Office Staff 1 (OS 1) stated the notes had to be downloaded from another electronic file and uploaded into the EMR by the end of the week from the visit date. The OS 1 accessed the other electronic file and obtained Patient 2’s PT notes. 2. During a review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 3/1/2204 to 4/29/2024, indicated a start of care date on 3/1/2024, with a primary diagnosis of monoplegia of the upper limb following unspecified cerebrovascular disease affecting the right dominant side (right upper arm paralysis). During a review on 5/15/2024 at 12:57 p.m. of Patient 5’s EMR, the EMR indicated Patient 5’ s start of care date was 3/1/2024. The EMR also indicated Patient 5’s plan of care dated 4/30/2024 to 6/28/2024, was created on 5/14/2024. During a concurrent interview and record review on 5/15/2024 at 10 a.m. with License Vocational Nurse 2 (LVN2) of Patient 5’s EMR, LVN2 stated she did not know when Patient 5’s current medical record titled “Home Health Certification and Plan of Care” was created. 3. During a review of Patient 6’s medical record titled “Patient Information” indicated a start of care date of 4/6/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review on 5/15/2024 at 12:03 p.m. of Patient 6’s EMR, the EMR indicated Patient 6’ s start of care date was 4/6/2024. The EMR also indicated Patient 6’s plan of care was created on 5/3/2024. During a concurrent interview and record review on 5/15/2024 at 10 a.m. with License Vocational Nurse 2 (LVN2) of Patient 6’s EMR, LVN2 stated Patient 6’s current medical record titled “Home Health Certification and Plan of Care” was not in her EMR yesterday and she did not know when it was created. During a review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 2/22/2204 to 4/21/2024, indicated a start of care date on 10/25/2023, with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. 4. During a review of Patient 7’s EMR, the EMR indicated Patient 7’s plan of care dated 10/25/2023 to 12/23/2023 was created on 11/15/2023 by the ADM/DON. During a review of Patient 7’s EMR, the EMR indicated Patient 7’s plan of care dated 12/24/2023 to 2/21/2023 was created on 1/21/2024 by the ADM/DON. During a review of Patient 7’s EMR, the EMR indicated Patient 7’s plan of care dated 2/22/2024 to 4/21/2024 was created on 3/20/2024 by the ADM/DON. During an interview on 5/15/2024 at 10:50 a.m. with LVN2, LVN2 stated patients plans of care should be completed with the information gathered from patients’ admission or recertification nursing assessment within five days. LVN2 stated nurses will not be aware of patients plan for care if patients plan of care are not created. A record review of the HHA’s policy and procedure titled, “Care/Service Coordination”, dated November 2021, indicated, “Procedure…Care coordination will include, but not be limited to…8. Written evidence of care coordination may be found in the plan of care/service, case conference summary forms, clinical notes in the patient’s clinical record or interdisciplinary group meeting notes…10. Contract organization personnel will participate in preparation of the plan of care/service; submit weekly documentation of services provided including clinical notes, schedule of visits, and patient evaluations/assessments…”.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to send all necessary medical information to the primary care practitioner within five days of discharge for one of seven sampled patients (Patient 7). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. During a review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 2/22/2204 to 4/21/2024, indicated a start of care date on 10/25/2023, with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 7’s Electronic Medical Record (EMR), the EMR indicated Patient 7 was discharged from the HHA on 4/19/2024. It also indicated Patient 7’s discharge order was created on 5/14/2024 by the Administrator/ Director of Nurses (ADM/DON). During a review of Patient 7’s Electronic Medical Record (EMR), the medical record titled “OASIS-E Discharge” indicated Patient 7 was discharged from the HHA on 4/19/2024. It also indicated Patient 7’s discharge nursing assessment was created on 5/14/2024 by the ADM/DON. During an interview on 5/17/2024 at 11:38 a.m. with the ADM/DON, the ADM/DON stated Patient 7’s medial doctor was verbally notified when Patient 7 was discharged. The ADM/DON stated nothing was documented to indicate Patient 7’s doctor was made aware of Patient 7’s discharge. The ADM/DON stated the doctor needed to know the patient was discharged and no longer receiving HHA services to follow up. The ADM/DON stated doctors also need to know if the discharge patient has met their goals. A record review of the HHA’s policy and procedure titled, “Discharge Summary”, dated November 2021, indicated, “Procedure…2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary and any necessary medical information will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge.”