Every finding on record at The Best Care Ever Home Health, Inc

The folowing reflects the findings of the Department of Public Health during a Complaint Validation Survey. Representing the Department of Public health : 19096, RN-HFEN 14065, RN-HFEN Total Sample -6 Home visits-3 The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey authorized by the Center for Medicare and Medicaid Services, Region 9, conducted on 1/12/2021 through 1/20/2021. Representing the California Department of Public Health: Surveyor ID # 19096, Health Facilities Evaluator Nurse Surveyor ID # 14065, Health Facilities Evaluator Nurse Complaint Intake Number: CA00720193 Current census: 20 Total Sample Size: 6 Home Visits: 3 Closed Record Reviews: 3 Conditions of Participation were issued to the Home Health Agency due to non-compliance with the Federal regulations at 42 C.F.R. Part 484 - Home Health Services.

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 by failing to: 1. Provide the information related the the care and notice of patient's rights in a language that the patients and the primary caregiver (PCG) can understand, for two of six sampled patients (Patient 1 and Patient 2). (Refer to G412). 2. Provide Skilled Nurse (SN) visits schedule to two of six sampled patients (Patient 1 and Patient 2). (Refer to G434). The cumulative effect of these systemic practices resulted in the failure of the agency to ensure the provision of quality health care in a safe environment.

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, for two of six sampled patients (Patient 1 and Patient 2), to provide the information related the the care and notice of patient's rights in a language that the patients and the primary caregiver (PCG) can understand. This deficient practice resulted in the patients and the PCG did not understand and exercise their rights and responsibilities when under the care of the HHA. This deficient practice also resulted in prohibiting the patients and the PCG to participate in planning their care. Findings: 1. A review of Patient 1's "Home Health Certification and Plan of Care" form (POC -[Form CMS-485]) indicated Patient 1's start of care date with the agency was 9/25/2020. The POC with the certification period, from 11/24/2020 to 1/22/2021, indicated Patient 1's primary diagnosis was essential hypertension (high blood pressure). The POC indicated Patient 1 was oriented and confused at times. A review of Patient 1's POCs for the certification period, dated 9/25/2020 through 11/23/2020 and 11/24/2020 through 1/22/2021, indicated Patient 1's rehabilitation potential was fair due to Patient 1's willingness to participate in plan of care. A home visit was conducted at Patient 1's residence on 1/13/2021, at 10:30 a.m. During a review of Patient 1's agency's home folder on 1/13/2021, at 11 a.m., there were no paper works found in the folder. During a concurrent interview with Patient 1 and Patient 1's PCG, Patient 1 stated when she started receiving services from the HHA, she was given a package of forms in English. Patient 1 stated that she just signed the forms but she did not really know what she signed as she could not read English. Patient 1 stated she returned the package back to the HHA because she did not understand English. Patient 1's PCG stated she could not participate fully in Patient 1's care because the information of patient's rights was given to them in English. Patient 1 and Patient 1's PCG stated they would like to receive their notice of patient's rights in a language that they can understand. 2. A review of Patient 2's POC indicated Patient 2's start of care date with the agency was 9/25/2020. The POC with the certification period, from 11/24/2020 to 1/22/2021, indicated Patient 2's primary diagnosis was Type 2 diabetes mellitus (problem with body to regulate blood sugar). The POC indicated Patient 2 was oriented, alert and confused at times. A review of Patient 2's POCs for the certification period, dated 9/25/2020 through 11/23/2020 and 11/24/2020 through 1/22/2021, indicated Patient 2's rehabilitation potential was fair due to Patient 2's willingness to participate in plan of care. A home visit was conducted at Patient 2's residence on 1/13/2021, at 10:30 a.m. A review of Patient 2's agency's home folder on 1/13/2021, at 11 a.m., was conducted. There were no paper works related to patient's rights and responsibilities found in the folder. During an interview with Patient 2 on 1/13/2021, at 11:40 a.m., Patient 2 stated he was not given any written materials from the HHA related to his rights and responsibilities as a patient of the HHA. During an interview with the Chief Executive Officer (CEO) of the HHA on 1/14/2021, at 3:45 p.m., the CEO stated she was in the process of obtaining a patient rights pamphlet in different languages besides English for her non-English speaking patients. The CEO stated it was an oversight on the HHA's part.

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 Home Health Agency (HHA) failed to provide Skilled Nurse (SN) visits schedule to two of six sampled patients (Patient 1 and Patient 2). This deficient practice resulted in these patients could not prepare for their SN visits and prevented these patients from participating in their care to the maximum extent possible. Findings: 1. A review of Patient 1's "Home Health Certification and Plan of Care" form (POC -[Form CMS-485]) indicated Patient 1's start of care date with the agency was 9/25/2020. The POC with the certification period, from 11/24/2020 to 1/22/2021, indicated Patient 1's primary diagnosis was essential hypertension (high blood pressure) with other pertinent diagnosis of Parkinson's disease (nervous system malfunction affecting motor abilities) and osteoarthritis (joint disease that breaks down the protective tissue in the bone). The POC indicated Patient 1 was oriented and confused at times. A review of Patient 1's POCs for the certification period, 11/24/2020 through 1/22/2021, indicated Patient 1's rehabilitation potential was fair due to Patient 1's willingness to participate in plan of care. SN visits frequency was two times a week for two weeks, and one time a week for seven weeks. A home visit was conducted at Patient 1's residence on 1/13/2021, at 10:30 a.m. During a review of Patient 1's agency's home folder and the HHA's clinical chart on 1/13/2021, at 11 a.m., there was no information found in these folders that shown when the HHA staff would visit Patient 1 when the the form titled, "Proposed Frequency of Visits" was left blank. During an interview with Patient 1 and Patient 1's PCG on 1/13/2021, at 11:11a.m., they stated they did not know when the HHA staff would come to visit Patient 1 as there was no schedule provided by the HHA. Patient 1 and Patient 1's PCG stated they would like to have a time schedule when the HHA staff would be coming to their home. 2. A review of Patient 2's POC indicated Patient 2's start of care date with the agency was 9/25/2020. The POC with the certification period, from 11/24/2020 to 1/22/2021, indicated Patient 2's primary diagnosis was Type 2 diabetes mellitus (problem with body to regulate blood sugar) with other pertinent diagnosis of hypertension (high blood pressure). The POC indicated Patient 2 was oriented, alert and confused at times. A review of Patient 1's POCs for the certification period, 11/24/2020 through 1/22/2021, indicated Patient 2's rehabilitation potential was fair due to Patient 2's willingness to participate in plan of care. SN visits frequency was two times a week for two weeks, and one time a week for seven weeks. A home visit was conducted at Patient 2's residence on 1/13/2021, at 10:30 a.m. During a review of Patient 1's agency's home folder and the HHA's clinical chart on 1/13/2021, at 11 a.m., there was no information found in these folders that shown when the HHA staff would visit Patient 1 when the the form titled, "Proposed Frequency of Visits" was left blank. During an interview with Patient 2 on 1/13/2021, at 2:10 p.m., Patient 2 stated he never really knows when the HHA staff would come to his home. Patient 2 stated that HHA staff usually would call him an half an hour or so before coming to his home. During an interview with the Director of Patient Services (DPCS) Designee on 1/19/2021, at 12:15 p.m., the DPCS Designee stated she was just newly hired to the agency about two weeks ago and she could not answer the question regarding SN visits schedule. The DPCS Designee stated due to low staffing, it was her understanding that the SN would visit when she could and; therefore, could not inform the patients of the visit schedule in advance. During an interview with the Chief Executive Officer (CEO) of the HHA on 1/14/2021, at 3:45 p.m., the CEO stated she was in the process of developing a calendar of home visits for Patient 1 and Patient 2. The CEO stated it was an oversight on the HHA's part.

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 observation, interview, and record review, the hospice agency failed to ensure the Condition of Participation for Comprehensive assessment of patients was met as follows: 1. The Home Health Agency (HHA) failed to ensure two out of six sampled patients (Patient 1 and 2) meet the home bound status and was eligible for the Medicare home health benefit. See G522. 2. The HHA failed to conduct a comprehensive and accurate assessment of the current health status for three of six sampled patients (Patent 4, Patient 5, and Patient 6). See G528. The cumulative effect of these systemic practices resulted in the failure of the agency to ensure the provision of quality health care in a safe environment.

Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed, for two of six sampled patients (Patient 1 and Patient 2), to ensure the patients met the criteria for home health services. This deficient practice resulted in admitting ineligible patients to receive home health benefit under the agency's care. Findings: 1. A review of Patient 1's "Home Health Certification and Plan of Care" form (POC -[Form CMS-485]) indicated Patient 1's start of care date with the agency was 9/25/2020. The POC with the certification period, from 11/24/2020 to 1/22/2021, indicated Patient 1's primary diagnosis was essential hypertension (high blood pressure) with other pertinent diagnosis of Parkinson's disease (nervous system malfunction affecting motor abilities) and osteoarthritis (joint disease that breaks down the protective tissue in the bone). The POC indicated Patient 1 was oriented and confused at times. A review of Patient 1's POCs for the certification period, dated 9/25/2020 through 11/23/2020 and 11/24/2020 through 1/22/2021, indicated an order for Skilled Nurse (SN) to provide home health services due to skilled nursing need and Patient 1's homebound status (a patient is considered homebound if they have a condition that restricts their ability to leave their home except with the aid of supportive devices, use of special transportation, the assistance of another person, and a condition, which is such that leaving his/her home is medically contraindicated.). A review of Patient 1's Home Health Assessment, dated 9/21/2020 and 11/13/2020, indicated Patient 1 was homebound because Patient 1 required taxing effort to leave her home due to the need for skilled nursing services, physical therapy, debilitating dizziness and poor ambulation. A review of the Comprehensive Adult Nursing Assessment-OASIS, dated 9/25/2020, and the Recertification Follow up Assessment-OASIS, dated 11/19/2020, indicated that Patient 1 was confined to home due to vertigo (a sensation of feeling off balance). Patient 1 required supportive devices; such as cane and walker, or special transportation, or assistance of another person to safely leave residence. The assessment indicated Patient 1 required taxing effort to leave home. The homebound and assessment portion of the OASISs indicated Patient 1 needed a walker, and therefore was homebound. The criteria section on the OASIS assessments to justify why Patient 1 met the homebound was left blank. A home visit was conducted at Patient 1's residence on 1/13/2021, at 10:30 a.m. During an observation conducted on 1/13/2021, at 11:45 a.m., Patient 1 was ambulating around her house independently without any shortness of breath or assistive device. During a concurrent interview with Patient 1, Patient 1 stated she ambulates and transfers without any difficulty and does not have any problems going to the eye doctor, dentist or her primary care doctor. Patient 1 stated she loves being out in the community and is very independent. She stated prior to the pandemic, she was even more active. Patient 1 further stated she rarely uses her cane and she does not have a walker. During an interview with the patient caregiver (PCG) on 1/13/2021, at 6:30 p.m., the PCG stated Patient 1 never has a walker. She stated Patient 1 is independent with her personal care and does not confined to home. The PCG stated she felt nervous that Patient 1 has been receiving services that she may not qualify for. The PCG stated the HHA staff did not explain the home health process and homebound status to her. The PCG stated she did not recall having a conversation with any HHA staff regarding the criteria of homebound status. The PCG stated the physician listed on the POC as the primary physician was not correct. A review of the Home Health Certification Statement, dated 10/7/2020, signed by Patient 1's physician, indicated a face-to-face encounter was conducted. The Home Health Certification Statement indicated Patient 1 required skilled nursing needs, such as nursing care and physical therapy, and the physician attested that Patient 1 was homebound by Medicare's definition. Multiple attempts to contact the physician from 1/14/2021 to 1/19/2021 were unsuccessful. The phone number listed for the physician was under the name of "The Mobile Drs" service. During an interview on 1/19/2021, at 11 a.m., the Director of Patient Services (DPCS) Designee stated she was hired to this position just two weeks ago, and she could not answer the question as to who Patient 1's primary physician was. During an interview with the Director of Patient Services (DPCS) Designee on 1/19/2021, at 2 p.m., the DPCS Designee stated the OASIS assessments were inaccurate and was not a true reflection of Patient 1's condition. The DPCS Designee stated that Patient 1 did not use a walker and also did not have vertigo or shortness of breath at rest. The DPCS Designee stated she could not explain why both OASIS assessments were not signed by the physician. The DPCS Designee further stated she did not have any further documentation or evidence to justify Patient 1 eligible for the home health services. A review of an undated HHA's policy and procedures, titled "Admission Criteria", indicated a patient must meet the home health care criteria to receive home care. There must be a primary need for skilled nursing and patient must be homebound. 2. A review of Patient 2's POC indicated Patient 2's start of care date with the agency was 9/25/2020. The certification period from 9/25/2020 to 11/23/2020, indicated Patient 2's primary diagnosis was Type 2 diabetes mellitus (problem with body to regulate blood sugar) with other pertinent diagnosis of hypertension (high blood pressure), sciatica (back pain) and osteoarthritis (joint disease that breaks down the cartilage in the bone). The POC indicated Patient 2 was oriented, alert and confused at times. Patient 2 had shortness of breath upon moderate exertion, weak and had moderate pain. Patient 2 utilized a cane and a walker to ambulate. A review of Patient 2's POCs for the certification period, dated 9/25/2020 through 11/23/2020 and 11/24/2020 through 1/22/2021, indicated an order for SN to provide home health services due to skilled nursing need and patient's homebound status. A review of Patient 2's Home Health Assessment, dated 9/21/2020 and 11/13/2020, indicated Patient 2 was homebound because it was a difficult and taxing effort to leave his home due to the need for skilled nursing services, physical therapy and poor ambulation. A review of the Comprehensive Adult Nursing Assessment-OASIS, dated 9/25/2020, and the Recertification Follow up Assessment-OASIS, dated 11/19/2020, indicated that Patient 2 was confined to home because he required supportive devices; such as a cane and a walker, or special transportation, or assistance of another person to safely leave residence. Patient 2 was unable to leave the home due to a taxing effort to leave the home. The homebound and assessment portion of the OASISs indicated Patient 2 needed a walker and, therefore Patient 2 was homebound. The criteria section on the OASIS assessments to justify why Patient 2 met the homebound was left blank. A home visit was conducted at Patient 2's residence on 1/13/2021, at 10:30 a.m. During an observation on 1/13/2021, at 11:40 a.m., Patient 2 was ambulating around his house independently without any shortness of breath. During a concurrent interview with Patient 2, Patient 2 stated he walks good and does not use a cane or a walker. Patient 2 stated he does not have any problems going to the doctor's office. During an interview with Patient 2's PCG on 1/13/2021, at 5 p.m., Patient 2's PCG stated the physician listed on the POC as the primary physician was not correct. A review of the Home Health Certification Statement, dated 10/7/2020, signed by Patient 2's physician, indicated a face-to-face encounter was conducted. The Home Health Certification Statement indicated Patient 2 required skilled nursing needs, such as nursing care and physical therapy, and the physician attested that Patient 1 was homebound by Medicare's definition. Multiple attempts to contact the physician from 1/14/2021 to 1/19/2021 were unsuccessful. The phone number listed for the physician was under the name of "The Mobile Drs" service. During an interview on 1/19/2021, at 11 a.m., the Director of Patient Services (DPCS) Designee stated she was hired to this position just two weeks ago, and she could not answer the question as to who Patient 2's primary physician was. During an interview with the Director of Patient Services (DPCS) Designee on 1/19/2021, at 2 p.m., the DPCS Designee stated the OASIS assessments were inaccurate and was not a true reflection of Patient 2's condition. She stated Patient 2 ambulates without difficulty or shortness of breath at rest. The DPCS Designee stated she could not explain why both OASIS assessments were not signed by the physician. The DPCS Designee further stated she did not have any further documentation or evidence to justify Patient 2 eligible for the home health services. During an interview with the DPCS Designee on 1/19/2021, at 2:15 p.m., the DPCS Designee stated Patient 2 was not homebound and he did not have a skilled need for home health services. A review of an undated HHA's policy and procedures, titled "Admission Criteria", indicated a patient must meet the home health care criteria to receive home care. There must be a primary need for skilled nursing and patient must be homebound.

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 interview and record review, the the Home Health Agency (HHA) failed to conduct a comprehensive and accurate assessment of the current health status for three of six sample patients (Patent 4, Patient 5, and Patient 6). This deficient practice had the potential to result in unmet needs and goals of the patients. Findings: 1. A review of Patient 4's clinical record indicated a start of care (SOC) date of 12/9/2020, for the certification period of 12/9/2020 to 2/6/2021. Patient 4's diagnosis included hypertensive chronic kidney disease (a medical condition referring to damage to the kidney due to chronic high blood pressure), Type 2 diabetes mellitus (a chronic condition that affects the way the body produces/process blood sugar), end stage renal disease (the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own), polyosteoarthritis (related to the process of aging, as water content of body cartilage increases, and the protein makeup of cartilage degenerates. Repetitive use of joints causes damage to cartilage, resulting in joint pain and swelling, and eventually cartilage will degenerate) and spinal stenosis (a narrowing of the spinal canal. Spinal stenosis can put pressure on the spinal cord and the nerves within the spine.) The physician ordered the skilled nurse (SN) to visit Patient 4 daily for four days, three times a week for two weeks, and then two times a week for two weeks, and then four times a week for one week. The POC indicated the SN was to assess, observe, evaluate cardiovascular, endocrine, nephrological, musculoskeletal, mental/emotional needs of the patient. The physician also ordered physical therapy to evaluate and provide treatment to the patient. A review of the Outcome and Assessment Information Set (OASIS, an assessment tool), dated 12/9/2020, indicate on the following: a. Page 6 under Vital signs, there was no pulse oximetry. b. Page 12 under cardiopulmonary respiratory treatment at home section, was blank, and that the patient was on oxygen (O2) as needed. c. Page 16 under psychosocial section, was blank. d. Page 22 under medical allergies section, was blank During concurrent virtual home visit, on 1/13/2021 at 2:30 pm., with Licensed Vocational Nurse (LVN) 1, patient caregiver (PCG), and Patient 4, all stated, during an interview, that at the SOC, the patient did not want to live anymore and was very depressed. Patient 4 stated he refused physical therapy services. LVN 1 stated she requested from the HHA for a social worker to come in. Patient 4 and the PCG stated it was LVN 1 who continued to come and changed his mind to want to live. A review of Patients 4's clinical record in the HHA office, on 1/15/2021, at 1:15 pm., indicated there was no social worker's (MSW's, Master's of Social Work) assessment or physician order for MSW visit and assessment in the clinical record. During an interview with the Director of Patient Care Services (DPCS) Designee, on 1/15/2021, at at 1:30 p.m., she stated she was informed by LVN 1 regarding Patient 4 around the SOC (no specific date mentioned) not wanting to live and was told by the LVN that she (DPCS Designee) had to request for an MSW's services. The DPCS Designee was unable to find the physicians order and MSW documentation and stated she is new as a designee and she had not reviewed any patient records. During an interview with the CEO/Owner, on 1/15/2021, she stated the DOPCS has a full time job elsewere and is not able to come to the office. 2. A review of Patient 5's Plan of Care (POC) indicated a SOC of 10/8/2020, for the certification period of 10/8/2020 to 12/6/2020. Patient 5 had diagnoses, that included, primary bilateral osteoarthritis (the breakdown of cartilage, a rubbery material that eases the friction in your joints), hypertensive heart disease (heart conditions caused by high blood pressure), heart failure (a heart that cannot keep up with its workload. The body may not get the oxygen it needs), unspecified dementia (a mental disorder in which a person loses the ability to think, remember, learn, make decisions, and solve problems), and dependence on wheelchair. The physician ordered for SN visit to visit Patient 5 one time a week for one week, two times a week for two weeks and one time a week for six weeks to assess the patient's vital signs, energy conservation techiques, and memory deficit, effects of medications on cognitive function and reaction to stimulation. The physician also ordered phyiscal therapy to evaluate and treat Patient 5. A review of Patient 5's OASIS, dated 10/8/2020, indicated the following: a. Page 2, under "Patient Representative" was blank, b. Page 3, under "History & Diagnosis" was blank. c. Page 4, under "Primary Diagnosis and Other Diagnosis" was blank. d. Page 28, under "Current DME/Medical Supplies" was blank. A review of Patient 5's OASIS, dated 12/3/2020, indicated the following: a. Page 2, under the diagnosis section was blank. b. Page 3, under " Immunizations and Sensory Status" was blank. A review of Patient 5's clinical record indicated the last skilled nurses notes in the clinical record was dated 11/24/2020. 3. A review of Patients 6's POC indicated a SOC date of 10/9/2020 for the certification period of 10/9/2020 to 12/7/2020. The patient diagnoses included muscle wasting, dependence on wheelchair, and paroxysmal atral fibrillation (an irregular, often rapid heart rate that commonly causes poor blood flow). The physician instructed the SN to visit the patient once a week for one week, twice a week for two weeks, and once a week for six weeks to provide comprehensive skilled nursing assessment, observaton and evaluation of pain, cardiovascular, mental and/or emotional and medications. The physician orered physical therapy to evaluate and treat. During a review of Patients 6's clinical record in the HHA office, on 1/19/2021 at 10:30 am., indicated the following on the computerized OASIS: a. Page 4, under "Diagnosis" was blank. b. Page 16, under "Psychosocial" was incomplete. c. Page 26, under "Therapy Need And Plan Of Care" was blank.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure that the Condition of Participation regarding Care Planning, Coordination of Services, and Quality of Care was met as follows: 1. The HHA failed to implement the physician's order to take, monitor, and document the blood pressure, and report elevated blood pressure readings to the physician for one of six sampled patients (Patient 1). See G578. 2. The HHA failed to teach and document appropriate pain management regimen for one of six sampled patients (Patient 1). See G610. 3. The Home Health Agency (HHA) failed to provide the patient and patient caregiver (PCG) a list of their medications and instructions for two of six sampled patients (Patient 1 and Patient 2). See G616. The cumulative effect of these systemic practices resulted in the failure of the agency to ensure the provision of quality health care in a safe environment.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician orders. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to implement the physician's order to take, monitor, and document the blood pressure, and report elevated blood pressure readings to the physician for one of six sampled patients (Patient 1). The deficient practice resulted in lack of measured blood pressure results/parameters for Patient 1 and delayed her progression in meeting her goals. Findings: A review of Patient 1's Home Health Certification and Plan of Care (POC) indicated a start of care date of 9/25/2020. The certification period from 9/25/2020 to 11/23/2020 indicated the patient's diagnoses included hypertension ( high blood pressure). The POC indicated the patient was alert with periods of confusion, had shortness of breath upon moderate exertion, was weak, and had moderate pain. Patient 1 was taking Amlodipine 5 milligrams (mg) by mouth twice a day and Lisinopril 20 mg one tablet by mouth once a day for high blood pressure. A review of Patient 1's plan of care (POC) for the certification period dated 9/25/2020 through 11/23/2020, included an order for home visits two times a week for two weeks and then one times a week for seven weeks. The POC indicated an order for the SN to take and monitor the patient's blood pressure as evidenced by maintenance of blood pressure within the range of 90/60mmHg to 160/90mmHg, and to document the blood pressure readings at the place of residence. The POC indicated for the patient and/or patient caregiver (PCG) to verbalize understanding of measures to prevent hypertensive exacerbation and signs/symptoms to observe and report to the physician such as elevated blood pressure readings. A review of Patient 1's POC for the certification period from 11/24/2020 to 1/22/2021, included the same information as above (POC for the certification period 9/25/2020 to 11/23/2020) for the patient and/or PCG to monitor, document and report elevated blood pressure readings to the physician. A review of the SN notes from 11/20/2020 to 1/10/2021 indicated there were missing SN notes. There was no blood pressure documentation at the HHA folder for Patient 1. There was no documentation of blood pressure readings at the patient's home. On 1/13/2021 at 11:45 a.m., during a home visit and observation of Patient 1, she stated she did not have any information on her blood pressure medications and she did not keep track of her blood pressure readings. The patient stated she did know she should keep track of her blood pressure readings. She stated the SN takes her blood pressure but does not give her any teachings regarding blood pressure medications or leaves any written information for her. The home folder for Patient 1 did not contain any information for her blood pressure medications or any blood pressure readings. During an interview with the patient's care giver (PCG), on 1/13/2021 at 6:30 p.m., she stated Patient 1's blood pressure sometimes goes "really high" and she was not aware the physician should be notified when the blood pressure elevates above the parameters ordered by the physician. She stated she could not explain why the blood pressure readings was not in the patient's home folder. She stated that when the patient's blood pressure goes "high" the patient will get confused and weak. She stated the patient has fallen down due to weakness in the past when her blood pressure was elevated. During an interview with the Director of Patient Care Services (DPCS) Designee, on 1/19/2021 at 4 p.m., she stated they were supposed to take the patient's blood pressure at every home visit and document the information in the clinical records at the agency and at the patient's home. A review of the HHA's policy and procedure titled, "Care Planning Process," undated, indicated the POC is a written plan of care that contains physician's orders that must be implemented to ensure appropriative and safe care is rendered for the patient. A review of the HHA's policy and procedure titled, " Blood Pressure Management," undated, indicated the agency will ensure that all patients/PCG admitted for service for high blood pressure be taught the appropriate care management as outlined in the patient's 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 observation, interview and record review, the Home Health Agency (HHA) failed to teach and document appropriate pain management regimen for one of six sampled patients (Patient 1). The deficient practice resulted in lack of pain assessment for Patient 1 and delayed her progression in meeting her goals. Findings: A review of Patient 1's Home Health Certification and Plan of Care (POC) indicated a start of care date of 9/25/2020. The certification period from 9/25/2020 to 11/23/2020 and 11/24/2020 to 1/22/2021 indicated the diagnoses that included was hypertension (high blood pressure), osteoarthritis (painful joint disease that breaks down the cartilage in the bone), and intervertebral disc disease (back pain as a result bone changes in the back of the vertebral). The POC indicated the patient was alert with periods of confusion and had moderate pain. A review of Patient 1's Clinical Notes by the SN, dated 9/28/2020 to 11/20/2020, indicated the patient had shortness of breath upon exertion and is unable to leave home without assistance. Patient 1 required considerable and taxing efforts to leave home even with assistance from caregiver. The patient had stiff joints, weakness and limited range of motion. The SN documented the patient had pain at every visit that was described as dull and relieved by rest, relaxation and the use of pain medications (Meloxicam 7.5 milligrams by mouth and Norco 5-325 milligrams by mouth). The intensity of the pain level from 1-10 (10 being the worst pain) was left blank. A review of the Comprehensive Adult Nursing Assessement tool, Outcome and Assessment Information Set (OASIS), dated 11/19/2020, indicated Patient 1 had moderate pain on a daily basis. A review of the POC for the certification period dated 11/24/2020 to 1/22/2021, included an order for skilled nurse (SN) to provide Patient 1 pain medications and to assess the patient's pain using the numeric pain scale (0 to 10, 6 to 10/10 being severe pain), implement pain relief measures and evaluate its effectiveness. Patient 1 required breakthrough pain medication less than daily. The physician ordered SN to visit the patient two times a week for two weeks, then one time a week for seven weeks. Patient 1's POC indicated the goals for Patient 1 during this certification period was to have less pain and improvement in mobility. The SN to assess and/or treat for pain and to document pain levels. SN to teach patient and patient caregiver (PCG) pain regimen. A review of Patient 1's SN note visits from 9/26/2020 to 1/14/2021 indicated lack of pain assessments conducted. The SN did not assess for pain using a pain scale as ordered by the physician. The pain assessment section was left blank. A review of the medication regimen or orders for Patient 1 included the following for pain medications: 1) Meloxicam 7.5 milligrams (mg) one tablet by mouth daily. 2) Norco 5-325 mg one tablet by mouth once daily as needed for pain. On 1/13/2021 at 11:45 a.m., during a home visit, Patient 1 was observed ambulating around the room with her cane. She stated she did not have shortness of breath but that she did have pain on her hips and back. She stated she could not describe the pain. There was no pain assessements and/or pain log at the home of the patient. During an interview with Patient 1 at the same time, she stated it was never given to her. Patient 1 provided a home folder that did not contain any information on her pain meds or written instructions and/or literature regarding pain meds and pain assessments. During an interview, on 1/19/2021 at 12:55 p.m., the Director of Patient Care Services (DPCS) Designee stated she could not explain why the pain assessment log was left blank at the home. She stated she could not explain why the list of the pain medications and the pain log was not left for the patient and PCG. She stated she did not know Patient 1 was experiencing a lot of pain. During an interview with the PCG, on 1/19/2021 at 1 p.m., she stated Patient 1 had a lot of pain but that it was getting better. She stated she would give her pain medications and sometimes the pain would go away and others times the pain persisted. She stated she was unsure if the pain medications was really working or if the patient needed something stronger or not. During a review of Patient 1's Clinical Record with (DPCS) Designee, on 1/19/2021 at 10 a.m., indicated the last clinical note was on 11/20/2020. She stated she could not explain why the notes from 11/20/2020 to 1/13/21 was missing. She stated that due to the pandemic, it had been difficult to hire and retain staff. A review of the HHA's policy and procedure titled, "Pain Management Education," undated, indicates SN would instruct per the plan of care, and document both medicinal and non-medicinal pain management/intervention as soon as receiving affirmation of pain to treat the pain before it becomes severe. SN is required to complete a comprehensive pain assessment during home visits as well as patient/PCG teachings and accurate documentation regarding pain assessment in accordance with accepted professional standards and principles.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to provide the patient and patient caregiver (PCG) a list of their medications and instructions for two of six sampled patients (Patient 1 and Patient 2). This deficient practice could result in potential adverse side effects and inadequate drug therapy. Findings: 1. A review of Patient 1's Home Health Certification and Plan of Care (POC) indicated a start of care date of 9/25/2020. The certification period from 9/25/2020 to 11/23/2020 indicated the patient's primary diagnosis was hypertension (high blood pressure) with other pertinent diagnosis of Parkinson's disease (nervous system malfunction affecting motor abilities), and osteoarthritis (joint disease that breaks down the cartilage in the bone). The POC indicated the patient was alert with periods of confusion, had shortness of breath upon moderate exertion, was weak, and had moderate pain. A review of Patient 1's Case Conference forms, dated 9/25/20 and 11/19/20, indicated Patient 1 had poor endurance, required use of a cane and was easily fatigued. She had knowledge deficits as it relates to her medication and needed patient teachings as it relates to her medications. The forms lacked signatures from other team members. The section for signatures for the other team members was left blank. A review of the Patient 1's POC for the certification period 11/24/2020 through 1//22/2021, included an order for home visits two times a week for two weeks and then one times a week for seven weeks. The POC indicated Patient 1 was at risk for poor medication management due to taking multiple medications. POC indicated for SN to instruct on disease management and the importance of compliance to medication regime. Further review of the POC indicated for SN to determine if patient/PCG is able to identify the correct dose, route, and frequency of each medication. SN to assess if the patient/PCG have knowledge of the signs and symptoms of ineffective drug therapy to report to SN or physician. SN to instruct patient/PCG on medication regime dose, indications, side effects, interactions, and adverse medication reactions. A review of the medication regime ororders for Patient 1 included the following: 1. Meloxican 7.5 milligrams (mg), 1 tablet by mouth once daily. 2. Norco 5-325 mg 1 tablet by mouth once a day as needed for pain. 3. Carbidopa/Levodopa 25-100mg 1 tablet by mouth three times a day. 4. Amlodipine 5mg 1 tablet by mouth once daily. 5. Lisinopril 20 mg 1 tablet by mouth at bedtime. 6. Ventolin HFA 90 mcg inhale 2 puffs twice daily. 7. Rosuvastin 10 mg 1 tablet by mouth once daily. 8. Vitamin B-complex 1 tab by mouth once daily. During the concurrent home visit and interview on 1/13/21 at 11:15 a.m. to 11:50 a.m., there was no medication profile observed at Patient 1's home. The PCG stated she that wanted to get this information so that she is fully aware of what Patient 1 is taking. The medication instructions including side effects of the medication was not given to her from the HHA. She figured since she did not have a medication list, she would just "make do" and look at the labels on the medication bottles. During an interview with the SN, on 1/13/2021 at 12:10 p.m., she stated she was in the process of providing the information but failed to do so. During an interview with the Director of Patient Care Services (DPCS) Designee, on 1/14/2021 at 1 p.m., she stated it was an oversight on the HHA's part. The DPCS Designee stated it is the responsibility of the SN to make sure the medication profile included all the information regarding use and side effects. The DPCS Designee stated the SN's responsibility included using the medication profile as a teaching tool during each visit. During an interview, on 1/14/2021 at 11 a.m., the DPCS Designee stated she was the only one that attended the case conference meetings for Patient 1 and therefore, the only signature on the forms was hers. She stated if the other team members attended the meetings, they would together realized Patient 1 had poor medication management from the HHA. A review of the HHA's policy and procedure undated, titled "Medication Management," undated, indicatds to reduce medication errors and promote safety throughout the home care program, the SN must provide and review with the patient and/or PCG the current medication regime and understanding of the medication actions and side effects. Medication information in a form of a medication list or pamphlets must be left in the home folder with the patient and/or PCG. The profile may also serve as a tool for the purpose of client/caregiver education. 2. A review of Patient 2's Home Health Certification and Plan of Care indicated a start of care date of 9/25/2020. The certification period from 9/25/2020 to 11/23/2020 indicated the patient's primary diagnosis was diabetes (blood sugar problems), with other pertinent diagnosis of hypertension (high blood pressure), sciatica (back pain) and osteoarthritis (joint disease that breaks down the cartilage in the bone). The POC indicated the patient was alert with periods of confusion, had shortness of breath upon moderate exertion, was weak, and had moderate pain. A review of the Case Conference forms dated 9/25/20 and 11/19/20, indicated Patient 2 had poor endurance, required use of a cane and was easily fatigued. He had knowledge deficits as it relates to his medication and needed patient teachings as it relates to his medications. The forms lacked signatures from other team members. The section for signatures for the other team members was left blank. A review of Patient 2's POC for the certification period dated 11/24/2020 through 1//22/2021, indicated an order for home visits two times a week for two weeks and then one times a week for seven weeks. The POC indicated Patient 2 was at risk for poor medication management due to taking multiple medications. The POC indicated for the SN to instruct on disease management and the importance of compliance to medication regime. . Further review of Patient 1's POC indicated for SN to determine if patient and/or PCG was able to identify the correct dose, route, and frequency of each medication. SN to assess if the patient and/or PCG have knowledge of the signs and symptoms of ineffective drug therapy to report to SN or physician. SN to instruct patient and/or PCG on medication regime dose, indications, side effects, interactions, and adverse medication reactions. A review of the medication regime or orders for Patient 2 included the following: 1. Metformin ER 1000 mg 1 tablet by mouth daily. 2. Tylenol 500 mg by mouth every 4-6 hours as needed for pain. 3. Lumigan 0.01% opth.sol. instill 1 drop to both eyes daily. 4. Amlodipine 10 mg 1 tablet by mouth once daily. 5. ASA 81 mg 1 tablet by mouth daily. 6. Hemacontine ER 1 capsule by mouth daily. 7. Atorvastatin 10 mg 1 tablet by mouth once daily. During the concurrent home visit and interview on 1/13/2021 at 12:05 a.m., there was no medication profile observed at the Patient 2's home. The PCG stated she that wanted to get this information so that she is fully aware of what Patient 2 is taking. The medication instructions including side effects of the medication was not given to her from the HHA. During an interview with the SN, on 1/13/2021 at 12:40 p.m., she stated she was in the process of providing the information but failed to do so. During an interview with the DPCS Designee, on 1/14/2021 at 1 p.m., she stated it was an oversight on the HHA's part. It is the responsibility of the SN to make sure the medication profile included all the information regarding use and side effects. The SN responsibility included using the medication profile as a teaching tool during each visit. During an interview on 1/14/21 at 11 a.m., the DPCS Designee stated she was the only one that attended the case conference meetings for Patient 2 and therefore, the only signature on the forms was hers. She stated if the other team members attended the meetings, they would together realized Patient 2 had poor medication management from the HHA.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on interview and record review, the agency failed to ensure the Condition of Participation for Organization and Administration Of Services was met as follows: 1. The Home Health Agency (HHA) failed to provide evidence that they had a governing body that assumed full legal authority and responsibility for the overall management and operation of the agency. See G942. 2. The Home Health Agency (HHA) failed to hire and appoint an administrator who would report to the governing body (designated persons that are responsible for the agency's overall management and operation), must ensure that a clinical manager is available during all operating hours, must ensure that that HHA employs qualified personnel, must assure the development of personnel qualifications and policies, and must be available during all operating hours. See G944. 3. The Home Health Agency (HHA) failed to appoint an administrator, who would report to the governing body. See G946. 4. The Home Health Agency (HHA) failed to appoint an administrator who would be responsible for the daily operations of the agency. See G948. 5. The Home Health Agency (HHA) failed to ensure a clinical manager, who is responsible for overall patient care services and personnel, is available during all operating hour (hours the HHA is open and providing care to patients). See G950. 6. The Home Health Agency ( HHA) failed to appoint a qualified, pre-designated person that is approved by the a governing body in writing to assume the duties and responsibilities of an administrator in the absence of an administrator. See G954. 7. The Home Health Agency ( HHA) failed to have an administrator or a pre-designated person available during all operating hours. See G956. 8. The Home Health Agency ( HHA) failed to ensure a qualified individual was able to provide oversight of all patient care services and personnel. See G958. 9. The Home Health Agency (HHA) failed to show and provide evidence of an annual budget plan, capital expenditure plan, and overall operating plan for the agency under the direction of a governing body (a groups of people who formulate the policy and the direct affairs of the institution). the agency did not have a governing body. See G988. The cumulative effect of these systematic practices resulted in the failure of the agency to ensure the provision of quality health care in a safe environment. The Condition is not met as evidenced by: The Agency failed to ensure that a governing body ( or designated persons so functioning) assumes full legal authority and respnsibility for the operation of the agency (G942); failed to ensure that a clinical manager is available during all operating hours (G952); failed to ensure that a qualified persons is authorized in writing to act in the abscence of the administrator (G954); failed to ensure the clinical record or minutes of case conferneces established that effective interchange, reporting,coordination of patient care occures. The cumulative effect of these systemic practices resulted in the failure of the Agency to deliv statutority mandated compliance with the Federalregulations for rganization, services and administration.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to provide evidence that they had a governing body that assumed full legal authority and responsibility for the overall management and operation of the agency. This deficient practice resulted in lack of oversight over patient care services and personnel, and had the potential to result in disorganized operation and direction of the agency that could cause negative outcomes to patients. Findings: 1. During an interview, on 1/14/2021 at 4 p.m., with the Chief Executive Officer (CEO)/Owner of the HHA, she stated she was in the process of hiring staff and developing a governing body since 2019, but she was not successful. She stated it has been hard to get a team together and she could not provide any documentation that a governing body exists. She stated they did not have a quality assessment and/or performance program at the HHA. During an interview with the CEO/Owner, on 1/19/2021 at 10 a.m. via telephone, she stated she could not be at the agency due to a family illness and that she had a binder of policies regarding the agency's organization and administration, but she could not locate the binder at the moment. 2. During an interview with the CEO/Owner of the HHA in the office, on 1/19 /2021 at 10 a.m via telephone, she and the Director of Patient Care Services (DPCS) Designee were asked who was the Medical Director of the HHA. The Owner and DPCS Designee could not answer the question. During an interview with the DPCS Designee via telephone, on 1/19/2021 at 3:30 pm., she stated she and the Owner did not know who is the Medical Director of the HHA and that the HHA uses mobile physicians who are not the patients primary physicians to visit the patients and sign the patients Plan of Care (POC). The DPCS Designee stated they do not know the patients primary physicians.

Administrator must: CFR(s): 484.105(b)(1) Standard: Administrator. The administrator must: This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to hire and appoint an administrator who would report to the governing body (designated persons that are responsible for the agency's overall management and operation), must ensure that a clinical manager is available during all operating hours, must ensure that that HHA employs qualified personnel, must assure the development of personnel qualifications and policies, and must be available during all operating hours. This deficient practice had the potential to result in disorganized operation and direction of the agency. Findings: On 1/12/2021 at 10 a.m., during the entrance at the HHA, the Chief Executive Officer (CEO)/Owner was asked to call the Director of Patient Care Services (DPCS) to come to facility for an entrance conference. The CEO/Owner attempted to call the DPCS but he was not reachable by phone and was not available for the validation survey. On 1/12/2021 at 12:30 pm., during an interview with the CEO/Owner in the office, she stated the DPCS had another job and due to the pandemic (an outbreak of a disease over a wide geographic area), he had not been to the agency. On 1/14/2021 at 4:10 p.m., during an interview with the CEO/Owner of the HHA, she stated she did not have an administrator for some time. She stated it has been difficult to hire new staff. On 1/15/2021 at 10 a.m., during an interview with the CEO/Owner via telephone, she stated she did not have any documented evidence of attempts made on hiring and appointing an administrator for the HHA. She stated she could not locate a policy (regarding the requirement of having an administrator) to furnish to the evaluator. On 1/19/2021 at 10 a.m., during an interview with the CEO/Owner via telephone, she stated she could not be at the agency due to a family illness and she had a binder of policies regarding the agency's organization and administration, but she could not locate the binder at the moment.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to appoint an administrator, who would report to the governing body (designated persons that are responsible for the agency's overall management and operation). This deficient practice had the potential to result in disorganized operation and direction of the agency. Findings: During an interview, on 1/14/2021 at 4 p.m., with the Chief Executive Officer (CEO)/Owner of the HHA, she stated she was in the process of hiring an administrator but she was unsuccessful. During an interview with the CEO/Owner, on 1/15/2021 at 10 a.m. via telephone, she stated she did not have any documented evidence of attempts made on hiring and appointing an administrator for the HHA. She stated she could not locate a policy (regarding the requirement of having an administrator) to furnish to the evaluator. During an interview with the CEO/Owner, on 1/19/2021 at 10 a.m., via telephone, she stated she could not be at the agency due to a family illness and she had a binder of policies regarding the agency's organization and administration, but she could not locate the binder at the moment.

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 interview and record review, the Home Health Agency (HHA) failed to appoint an administrator who would be responsible for the daily operations of the agency. This deficient practice had the potential to result in disorganized operation and direction of the agency. Findings: During an interview, on 1/14/2021 at 4 p.m., with the Chief Executive Officer (CEO)/Owner of the HHA, she stated she was in the process of hiring an administrator but she was unsuccessful. During an interview with the CEO/Owner, on 1/15/2021 at 10 a.m. via telephone, she stated she did not have any documented evidence of attempts made on hiring and appointing an administrator for the HHA. She stated she could not locate a policy (regarding the duties and responsibilities an administrator) to furnish to the evaluator.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: 2. On 1/14/2021 at 4 p.m., during an interview with the CEO/Owner of the HHA, she stated she was in the process of hiring a clinical manager but was not successful since 2019. On 1/19/2021 at 10 a.m., during an interview with the CEO/Owner via telephone, she stated she did not have any documented evidence of attempts made to hire and appoint a clinical manager for the HHA. On 1/19/2021 at 1 p.m,, during an interview with the CEO/Owner of the HHA, she stated she did not have a policy, regarding clinical manager's availability during the HHA's operating hours, to furnish to the evaluator. Based on interview and record review, the Home Health Agency (HHA) failed to ensure a clinical manager, who is responsible for overall patient care services and personnel, is available during all operating hour (hours the HHA is open and providing care to patients). The deficient practice placed the patients at risk of not receiving the care ordered by the physician. Findings: 1. On 1/12/2021 at 10 a.m., during the entrance at the HHA, the Chief Executive Officer (CEO)/Owner was asked to call the Director of Patient Care Services (DPCS) to come to facility for an entrance conference. The CEO/Owner attempted to call the DPCS but he was not reachable by phone and was not available for the validation survey. On 1/12/2021 at 12:30 pm., during an interview with the CEO/Owner in the office, she stated the DPCS had another job and due to the pandemic (an outbreak of a disease over a wide geographic area), he had not been to the agency.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency ( HHA) failed to appoint a qualified, pre-designated person that is approved by the a governing body (designated persons that are responsible for the agency's overall management and operation) in writing to assume the duties and responsibilities of an administrator in the absence of an administrator. This deficient practice had the potential to result in a disorganized operation and direction of the agency. Findings: During an interview, on 1/14/2021 at 4 p.m., with the Chief Executive Officer (CEO)/Owner of the HHA, she stated she was in the process of hiring a qualified person to assume the role of administrator while the HHA looked for a permanent administrator, but she was unsuccessful. During an interview with the CEO/Owner of HHA, on 1/19/2021 at 10 a.m., via telephone, she stated she did not have any documented evidence of attempts made on hiring and appointing a pre-designated person for the HHA. Based on record review, and staff interview, the HHA failed to ensure a qualified person was authorized in writing to act in the absence of the administrator. Findings: On 1/12/2021 at 10: 00 a.m., during the entrance of the HHA, the CEO was asked to call the Director of Patient Care Services (DPCS) to come to facility to conduct entrance conference. He was not reachable by phone and was not available or the validation survey. On 1/12/2021 at 12:30 pm., during the entrance conference with the designee, she stated she was not aware of the current census, did not know anything about the responsibilities the designee of the HHA and had not meet the other employees. The Designee stated she was hired 2 months ago. There was no written documentation of appointment by the governing body for the DPCS & Designee

Available during all operating hours CFR(s): 484.105(b)(3) The administrator or a pre-designated person is available during all operating hours. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency ( HHA) failed to have an administrator or a pre-designated person available during all operating hours. This deficient practice had the potential to result in disorganized operation and direction of the agency. Findings: During an interview, on 1/14/2021 at 4 p.m., with the Chief Executive Officer (CEO)/Owner of the HHA, she stated she was in the process of hiring a qualified person to assume the role of administrator during all operating hours but she was unsuccessful. During an interview with the CEO/Owner, on 1/19/2021 at 10 a.m. via telephone, she stated she did not have any documented evidence of attempts made at hiring and appointing an administrator, pre-designated person, or clinical manager for the HHA. She stated she did not have a policy regarding administration or assignment for a pre-designated person in lieu of an administrator.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency ( HHA) failed to ensure a qualified individual was able to provide oversight of all patient care services and personnel. This deficient practice resulted in lack of oversight on patient care services and ordered treatments and services not given, placing the patients at risk for negative outcomes. Findings: On 1/12/2021 at 10 a.m., during the entrance at the HHA, the Chief Executive Officer (CEO)/Owner was asked to call the Director of Patient Care Services (DPCS) to come to facility for an entrance conference. The CEO/Owner attempted to call the DPCS but he was not reachable by phone and was not available for the validation survey. On 1/12/2021 at 12:30 pm., during an interview with the CEO/Owner in the office, she stated the DPCS had another job and due to the pandemic (an outbreak of a disease over a wide geographic area), he had not been to the agency On 1/12/2021 at 12:31 pm., during the entrance conference with the DPCS Designee, she stated she was not aware of the current census, did not know anything about the responsibilities of the DPCS Designee of the HHA, and had not meet the other employees. The DPCS Designee stated she was hired two (2) months ago. The facility was not able to provide a written documentation of appointment by the governing body for the DPCS and DPCS Designee.

Institutional planning CFR(s): 484.105(h) Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1) Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense. (2) Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA. (4) Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to show and provide evidence of an annual budget plan, capital expenditure plan, and overall operating plan for the agency under the direction of a governing body (a groups of people who formulate the policy and the direct affairs of the institution). the agency did not have a governing body. This deficient practice had the potential to result in unaccounted and underreporting of income and expenditures. Findings: During an interview, on 1/14/21 at 4 p.m., with the Chief Executive Officer (CEO)/Owner of the HHA, she stated she was in the process of hiring staff and developing a governing body since 2019 but she was not successful. She stated she could not provide any documentation that a governing body existed. . During an interview, on 1/14/21 at 4:15 p.m. with the CEO/Owner of the HHA, she stated the agency did not have a annual overall operating plan (that includes all anticipatied income and expenses). During an interview with the CEO/Owner of the HHA, on 1/14/21 at 4:30 p.m., she stated she did not have a policy regarding governing body to furnish to the evaluator.

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) 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 agency failed to ensure that the Condition of Participation regarding Clinical Records was met as follow: 1. The Home Health Agency (HHA) failed to ensure the clinical records for three of six sampled patients (Patient 4, Patient 5, and Patient 6) contained a complete and accurate comprehensive assessment, physician order, and social worker notes. See G1012. 2. The HHA failed to re-evaluate the progress of two of six sampled patients (Patient 5 and Patient 6) after meeting the goals of physical therapy (a care that aims to ease pain and help you function, move, and live better) and for continued need of physical therapy after the goals had been met. See G1016. The cumulative effects of these systemic practices resulted in the failure of the agency to deliver mandated compliance with clinical records and to ensure the provision of 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 orders; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the clinical records for three of six sampled patients (Patient 4, Patient 5, and Patient 6) contained a complete and accurate comprehensive assessment, physician order, and social worker notes. This deficient practice had the potential to result in not meeting the needs of the patients. Findings: 1. On 1/13/2021 at 2:15 p.m., during a review of Patient 4's clinical record, the record indicated a start of care (SOC) date of 12/9/2020, for the certification period of 12/9/2020 to 2/6/2021. Patient 4's diagnoses included hypertensive chronic kidney disease (a medical condition referring to damage to the kidney due to chronic high blood pressure), type 2 diabetes mellitus (a chronic condition that affects the way the body produces and processes blood sugar), end stage renal disease (the kidney function has declined to the point that the kidneys can no longer function on their own), polyosteoarthritis (related to the process of aging, as water content of body cartilage increases, and the protein makeup of cartilage degenerates. Repetitive use of joints causes damage to cartilage, resulting in joint pain and swelling, and eventually cartilage will degenerate), and spinal stenosis (a narrowing of the spinal canal. Spinal stenosis can put pressure on the spinal cord and the nerves within the spine.) A review of Patient 4's Outcome and Assessment Information Set (OASIS, a patient specific standardized assessment tool), dated 12/9/2020, indicated the following: a. Page 6, under vital signs section, there was no pulse oximetry. b. Page 12, under "cardiopulmonary respiratory treatment at home" was blank and the patient was on oxygen (O 2) as needed. c. Page 16, under psychosocial section, was blank. d. Page 22, under medical allergies section, was blank. On 1/13/2021 at 2:30 p.m., during a virtual home visit with Licensed Vocational Nurse (LVN) 1, the patient's caregiver (PCG) and Patient 4 stated, during an interview, that at the SOC, the patient did not want to live anymore and was very depressed. Patient 4 stated he refused physical therapy services and LVN 1 stated she requested from the HHA a social worker to visit the patient. Patient 4 and the PCG stated LVN 1 who continued to come and changed his mind to want to live. On 1/15/2021 at 1:15 p.m., during a review of Patients 4's clinical record in the HHA office, the record indicated was no assessment from a social worker with Master's of Social Work (MSW) degree or a physician order for MSW visits in the clinical record. On 1/15/2021 at 1:30 p.m., during an interview with the Director of Patient Care Services (DPCS) Designee, she stated LVN 1 informed her during the certification period that Patient 4 did not want to live and that the Designee needed to request a MSW to visit the patient. The Designee was unable to find the physicians order for MSW to visit Patient 4 and MSW documentations of the visit. The DPCS Designee stated she is new in the HHA and she has not reviewed any records,. On 1/15/2021 at 12:45 p.m., during an interview with the Chief Executive Officer (CEO)/Owner, she stated the DPCS has a full time job elsewhere and is not able to come to the office. 2. A review of Patient 5's Plan of Care (POC) indicated a SOC of 10/8/2020, for the certification period of 10/8/2020 to 12/6/2020. Patient 5 had diagnoses, that included, primary bilateral osteoarthritis (the breakdown of cartilage, a rubbery material that eases the friction in your joints), hypertensive heart disease (heart conditions caused by high blood pressure), heart failure (a heart that cannot keep up with its workload. The body may not get the oxygen it needs), unspecified dementia (a mental disorder in which a person loses the ability to think, remember, learn, make decisions, and solve problems), and dependence on wheelchair. A review of Patient 5's OASIS, dated 10/8/2020, indicated the following: a. Page 2, under "Patient Representative" was blank, b. Page 3, under "History & Diagnosis" was blank. c. Page 4, under "Primary Diagnosis and Other Diagnosis" was blank. d. Page 28, under "Current DME/Medical Supplies" was blank. A review of Patient 5's OASIS, dated 12/3/2020, indicated the following: a. Page 2, under the diagnosis section was blank. b. Page 3, under " Immunizations and Sensory Status" was blank. A review of Patient 5's clinical record indicated the last skilled nurses notes in the clinical record was dated 11/24/2020. 3. A review of Patients 6's POC indicated a SOC date of 10/9/2020 for the certification period of 10/9/2020 to 12/7/2020. The patient diagnoses included muscle wasting, dependence on wheelchair, and paroxysmal atral fibrillation (an irregular, often rapid heart rate that commonly causes poor blood flow). During a review of Patients 6's clinical record in the HHA office, on 1/19/2021 at 10:30 am., indicated the following on the computerized OASIS: a. Page 4, under "Diagnosis" was blank. b. Page 16, under "Psychosocial" was incomplete. c. Page 26, under "Therapy Need And Plan Of Care" was blank.

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to re-evaluate the progress of two of six sampled patients (Patient 5 and Patient 6) after meeting the goals of physical therapy (a care that aims to ease pain and help you function, move, and live better) and for continued need of physical therapy after the goals had been met. The deficient practice resulted in a repeat in physical therapy every certification period with no documented evidence that physical therapy was still needed. Findings: 1. A review of Patient 5's Admission Order, dated 10/8/2020, indicated to admit the patient to the HHA and an order for physical therapy (PT) evaluation and follow up treatment. A review of Patient 5's Supplementary Physicians Order, dated 10/8/2020, indicated an order for the Physical Therapist (PT 1) to visit Patient 5 one time a week for six weeks and 2 times a week for two weeks for therapeutic exercise, gait training, pain management, balance exercise, soft tissue (commonly used to described muscles) mobilization, bed mobility training, home safety protocol, family/caregiver education, transfer training, equipment training, and body mechanics (the way we move). A review of Patient 5's Plan of Care (POC) indicated a start of care (SOC) of 10/8/2020, for the certification period of 10/8/2020 to 12/6/2020. Patient 5 had diagnoses, that included, primary bilateral osteoarthritis (the breakdown of cartilage, a rubbery material that eases the friction in your joints), hypertensive heart disease (heart conditions caused by high blood pressure), heart failure (a heart that cannot keep up with its workload. The body may not get the oxygen it needs), unspecified dementia (a mental disorder in which a person loses the ability to think, remember, learn, make decisions, and solve problems), and dependence on wheelchair. The Orders for Discipline and Treatment on the POC indicated an order for PT evaluation and treatment. A review of Patient 5's discharge notes by PT 1, dated 11/25/2020, indicated the patient was okay to discharge. Patient 5 showed significant improvement in all aspects of PT therapeutic exercises. Patient 5's generalized weakness has decreased and the patient no longer exhibited the straining pain from the beginning of the PT program. Patient 5 was fully capable of recognitizing fall risk factors in a number of areas besides the patient's home. Patient 5 had determined this by giving the patient scenarios in which the fall risk needed to be identified. Patient 5 demonstrated proper use of the assistive device. A review of the Patient 5's Physical Therapy Discharge Summary/Discharge orders, dated 11/25/2020, indicated "No further care needed at this time," and "goals met." A review of the Patient 5's Supplementary Physicians Orders", dated 11/25/2020, indicated "Discharge physical therapy as of today," and "Goals met at this time." A review of Patient's 5 Plan of Care indicated a SOC of 10/8/2020 and a certification period of 12/7/2020 to 2/4/2021. The Orders for Discipline and Treatment on the POC indicated an order for PT evaluation and treatment. A review of Patient 5's Supplementary Physician's Orders, dated 12/8/2020, indicated an order for PT 1 to visit the patient two times a week for five weeks for therapeutic exercise, gait training, pain management, balance exercise, soft tissue mobilization, bed mobility training, home safety protocol, family and/or caregiver education, transfer training, equipment training, and body mechanics. The order was not signed by the patient's attending physician. A review of Patient 5's discharge notes by PT 1, dated 1/8/2021, indicated the patient was okay to discharge. Patient 5 showed significant improvement in all aspects of PT therapeutic exercises. Patient 5's generalized weakness has decreased and the patient no longer exhibited the straining pain from the beginning of the PT program. Patient 5 was fully capable of recognitizing fall risk factors in a number of areas besides the patient's home. Patient 5 had determined this by giving the patient scenarios in which the fall risk needed to be identified. Patient 5 demonstrated proper use of the assistive device. A review of Patient 5's Physical Therapy Discharge Summary/Discharge orders, dated 1/8/2021, indicated "No further care needed at this time," and "goals met." A review of the Patient 5's Supplementary Physicians Orders", dated 1/8/2021, indicated "Discharge physical therapy as of today," and "Goals met at this time." The Supplementary Physician's Order was not signed by the physician. 2. A review of Patient 6's Admission Order, dated 10/9/2020, indicated to admit the patient to the HHA and an order for PT evaluation and treatment. A review of Patient 6's Supplemental Orders, dated 10/10/2020, indicated an order for PT frequency of once a week for seven weeks for therapeutic exercise, gait training, home exercise program, pain management, balance exercise, soft tissue mobilization, bed mobility training, home safety protocol, family and/or caregiver education, transfer training, equipment training, and body mechanics. The order was not signed by the patient's attending physician. A review of Patients 6's POC indicated a SOC date of 10/9/2020 for the certification period of 10/9/2020 to 12/7/2020. The patient diagnoses included muscle wasting, dependence on wheelchair, and paroxysmal atral fibrillation (an irregular, often rapid heart rate that commonly causes poor blood flow). The Orders for Discipline and Treatment on the POC indicated an order for PT evaluation and treatment. A review of the Patient 6's Physical Therapy Discharge Summary/Discharge orders, dated 11/25/2020, indicated "No further care needed at this time," and "goals met." A review of Patient 6's Supplementary Physician Orders, dated, 11/15/2020, indicated "Discharge physical therapy as of today," and "Goals met at this time." The Supplementary Physician's Order was not signed by the physician. A review of Patient's 6's Plan of Care indicated a SOC of 10/9/2020 and a certification period of 12/8/2020 to 2/5/2021. The Orders for Discipline and Treatment on the POC indicated an order for PT evaluation and treatment. A review of Patient 6's Supplemental Orders, dated 12/9/20, indicated an order for physical therapy once a week for seven weeks for therapeutic exercise, gait training, home exercise program, pain management, balance exercise, soft tissue mobilization, bed mobility training, home safety protocol, family and/or caregiver education, transfer training, equipment training, and body mechanics. The order was not signed by the patient's attending physician. Multiple calls to the PT 1 was placed for an interview. The PT 1 never responded back.