Every finding on record at Angel Home Health Services, Inc.

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey conducted on 12/6/2023 to 12/10/2023. Federal Intake Number: 102357 Representing the California Department of Public Health: Surveyor ID # 43979 -RN - HFEN Surveyor ID # 43929 -RN - HFEN Census: 20 Sample Size: 7 Home Visits: 3 Closed Record review: 2 On 12/8/2023, at 3:54 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the ADM/DPCS, and the Intake Coordinator (IC), for the HHA failure to ensure the ADM/DPCS and or a qualified designee provided the day-to-day operations of the agency and patient care oversight for three of seven sampled patients (Patient 1, Patient 5, and Patient 6) by failing to: 1. Ensure the ADM/DPCS conducted the initial assessment to determine the immediate care and support needs for Patient 1, Patient 5, and Patient 6, within five days from admission. 2. Ensure the ADM/DPCS developed a plan of care (POC, an individualized plan indicating a patient’s health condition, specific care needs, and current treatments). for Patient 1, Patient 5, and Patient 6 within seven days from admission. On 12/9/2023, 11:24 a.m., at the agency submitted an IJ removal Plan and was not accepted. On 12/10/2023, at 9:52 a.m., the agency submitted an IJ removal Plan and was not accepted. On 12/10/2023, at 12:30 p.m., the survey team completed the survey tasks, and exited with the Immediate Jeopardy not removed. The following Condition of Participation was not met: 484.105 Organization and administration of services. 484.55 Condition of Participation: Comprehensive Assessment of Patients 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care 484.110 Condition of Participation: Clinical Records

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure the OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes) were transmitted within 30 days of completing the assessment for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7) This deficient practice had the potential not to meet the needs of Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7. Cross reference G520. 1. During a review of Patient 1’s Patient Information, the Patient Information indicated the start of care date of 9/28/2023. The Patient Information did not indicate Patient 1's admission diagnosis. During a review of Patient 1’s Home Health (HH) Referrals and Orders, dated 9/25/2023, the HH Referrals and Orders indicated, “services needed: skilled nursing, physical therapy. For the following reasons: COPD (a lung disease that makes breathing difficult), HTN (hypertension, high blood pressure), CHF (Congestive Heart Failure, heart does not pump blood well), Dementia (impaired ability to remember, think or make decisions), GERD (stomach acid flows back to the tube connecting mouth and stomach), hypothyroidisms (low function of the thyroid), unsteady gait,…SN (skilled nurse) for evaluation, teaching on disease proves, medication management, medication compliance, home safety, blood pressure monitoring. PT (Physical Therapy) for strengthening & balance to assist with balance, coordination and strengthening of upper/lower body to maximize potential. During an interview on 12/7/2023, at 12:09 p.m., the Administrator/Director of Patient (ADM/DPCS) stated she did not have the initial comprehensive assessment completed for Patient 1. The ADM/DCPS stated there were no notes about her assessment in her medical record, both paper chart and electronic record. The ADM/DPCS stated Patient 1 had been assessed, but the information was not documented. 2. During a review of Patient 2’s Home Health Certification and Plan of Care, for certification period 9/28/2023 to 11/16/2023, the Home Health Certification and Plan of Care indicated a start of care date of 9/18/2023, with diagnoses including post (after) procedural pain. During the survey, an OASIS transmittal was not provided from the HHA. 3. During a review of Patient 3’s Home Health Certification and Plan of Care, for certification period 9/28/2023 to 11/26/2023, the Home Health Certification and Plan of Care indicated a start of care day of 9/29/2023, with diagnoses including osteoarthritis (joint stiffening, swelling, causing pain or discomfort). During a review of Patient 3’s OASIS Agency Final Validation report, the OASIS Agency Final Validation report indicated a new record was submitted to CMS on 11/20/2023. Further review of the record indicated the record was submitted late. “The submission date is more than 30 days after M0090 (the date the assessment was done, on 11/22/2023) on this new record. 4. During a record review of Patient 4’s Home Health Certification and Plan of Care, for certification period 5/26/2023 to 7/24/2023, the Home Health Certification and Plan of Care indicated a start of care day of 5/26/2023, with diagnoses including a fracture (broken bone). During a review of Patient 4’s OASIS Agency Final Validation report, the OASIS Agency Final Validation report indicated the record was submitted late. The submission date is more than 30 days after M0090 (the date the assessment was done) on this new record. 5. During a review of Patient 5’s Home Health Certification and Plan of Care dated 11/19/2023 to 1/17/2024, the Home Health Certification and Plan of Care indicated a start of care date of 11/19/2023 with a principal diagnosis of Type 2 diabetes mellitus with (a medical condition characterized by the body's inability to regulate blood sugar levels). The Home Health Certification and Plan of Care indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were blank. During the survey, an OASIS transmittal for Patient 5 was not provided from the HHA. 6. During a review of Patient 6’s Home Health Certification and Plan of Care, dated 11/2/2023 to 12/31/2023, indicated a start of care date of 11/2/2023 with a principal diagnosis of essential (primary) hypertension (high blood pressure) the Home Health Certification and Plan of Care, indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were blank. During the survey, an OASIS transmittal for Patient 5 was not provided from the HHA. 7. During a review of Patient 7’s Home Health Certification and Plan of Care, dated 4/24/2023 to 6/22/2024, the Home Health Certification and Plan of Care indicated a start of care date of 4/24/2023 with a principal diagnosis of infective dermatitis (a severe form of recurrent inflammation, redness, itching, and oozing skin change that presents in childhood). During a review of Patient 7’s OASIS Agency Final Validation, with a submission date of 6/22/2023, indicated “Record Submitted Late: The submission date is more than 30 days after M0090 on this new record.” It also indicated “Eff Date: 4/24/2023.” During a review of Patient 7’s OASIS Agency Final Validation, with a submission date of 8/21/2023, indicated “Record Submitted Late: The submission date is more than 30 days after M0090 on this new record.” It also indicated “Eff Date: 6/22/2023.” During an interview on 12/8/2023, at 3:31 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) stated the OASIS was more than 30 days late for all the patients because she was behind. The ADM/DPCS stated it was a regulation to have the OASIS within 30 days of assessment. A record review of the HHA’s policy and procedure titled, “OASIS Data Transmission”, dated 2009, indicated, “Procedure: 1. The organization will encode and transmit completed OASIS data foreach applicable patients within thirty (30) days of the M0090 date, date assessment completed.”

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7) received information regarding the State toll free home health complaint telephone hotline, its contact information, its hours of operation, and its purpose. This failure resulted in a violation of patient’s rights due to not having the information necessary to make a complaint regarding the agency’s care. 1. During a review of Patient 1’s Patient Information, the Patient Information indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. During an observation and interview on 12/8/2023, at 1:35 p.m., inside Patient 1's residence with the Administrator/Director of Patient Care Services (ADM/DPCS), with Patient 1’s caregiver (CG 1), the CG1 stated she did not know how to contact the State Department to report concerns about the care being provided. 2. During a review of Patient 2’s record titled Home Health Certification and Plan of Care, for certification period 9/28/2023 to 11/16/2023, the Home Health Certification and Plan of Care indicated a start of care date of 9/18/2023, with diagnoses including post (after) procedural pain. 3. During a review of Patient 3’s Home Health Certification and Plan of Care, for certification period 9/28/2023 to 11/26/2023, the Home Health Certification and Plan of Care indicated a start of care day of 9/29/2023, with diagnoses including osteoarthritis (joint stiffening, swelling, causing pain or discomfort). 4. During a review of Patient 4’s Home Health Certification and Plan of Care, for certification period 5/26/2023 to 7/24/2023, the Home Health Certification and Plan of Care, indicated a start of care day of 5/26/2023, with diagnoses including a fracture (broken bone). 5. During a review of Patient 5’s Home Health Certification and Plan of Care, dated 11/19/2023 to 1/17/2024, the Home Health Certification and Plan of Care indicated a start of care date of 11/19/2023 with a principal diagnosis of Type II diabetes mellitus with (a medical condition characterized by the body's inability to regulate blood sugar levels) It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. 6. During a review of Patient 6’s Home Health Certification and Plan of Care, dated 11/2/2023 to 12/31/2023, the Home Health Certification and Plan of Care indicated a start of care date of 11/2/2023 with a principal diagnosis of essential (primary) hypertension (high blood pressure). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were blank. During a joint home visit on 12/8/2023 at 1:15 p.m., with Licensed Vocational Nurse 1 (LVN1) to Patient 6’s home, LVN1 was unable to locate the tollfree State complaint hotline information in Patient 6’s HHA patient folder. 7. During a review of Patient 7’s Home Health Certification and Plan of Care, dated 4/24/2023 to 6/22/2024, the Home Health Certification and Plan of Care, indicated a start of care date of 4/24/2023 with a principal diagnosis of infective dermatitis (a severe form of recurrent inflammation, redness, itching, and oozing skin change that presents in childhood). During a concurrent interview and record review on 12/7/2023, at 11 a.m., with the ADM/DPCS of patient admission folder, ADM/DPCS was unable to locate the tollfree California State complaint hotline. ADM/DPCS called a number listed on form “(HHA) Client Bill of rights & responsibilities” (800/792-9770). ADM/DPCS stated the recording stated it was New Jersey State complaint hotline number. During an interview on 12/7/2023 at 1:30 p.m. with ADM/DPCS, ADM/DPCS stated patients needed to have access to the tollfree State complaint number in case they want to place a complaint or want to voice concerns that have not been solved by the HHA. ADM/DPCS stated patients have the right to be heard and needed to be provided with the tollfree State complaint hotline number. ADM/DPCS stated patients’ rights were violated by not being provided with the number. ADM/DPCS patients might feel they were lied to and misinformed if the call the wrong number provided. ADM/DPCS stated “It’s like stealing from them, they get the Medicare statement and if they didn’t agree with the payment, they have the right to call in and file a dispute.” A record review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, dated 2009, indicated, “Procedure: 1. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following…O. The right to voice a complaint or concern regarding care or service. The availability of other sources to receive questions and complaints and assist in resolution…T. The availability of the applicable toll-free home health agency hotline and other resources to receive questions or complaints…”.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7) received information regarding a listing of State and Federally funded programs. This failure resulted in a violation of patient’s rights due to not having information available for a broad range of services, like food, housing, and utility bill assistance. 1. During a review of Patient 1’s Patient Information record, the Patient Information record indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. 2. During a review of Patient 2’s Home Health Certification and Plan of Care, for certification period 9/28/2023 to 11/16/2023, the Home Health Certification and Plan of Care indicated a start of care date of 9/18/2023, with diagnoses including post (after procedural pain). 3. During a review of Patient 3’s Home Health Certification and Plan of Care, for certification period 9/28/2023 to 11/26/2023, the Home Health Certification and Plan of Care indicated a start of care day of 9/29/2023, with diagnoses including osteoarthritis (joint stiffening, swelling, causing pain or discomfort). 4. During a review of Patient 4’s Home Health Certification and Plan of Care, for certification period 5/26/2023 to 7/24/2023, the Home Health Certification and Plan of Care indicated a start of care day of 5/26/2023, with diagnoses including a fracture (broken bone). 5. During review of Patient 5’s Home Health Certification and Plan of Care, dated 11/19/2023 to 1/17/2024, the Home Health Certification and Plan of Care indicated a start of care date of 11/19/2023 with a principal diagnosis of Type II diabetes mellitus with (a medical condition characterized by the body's inability to regulate blood sugar levels). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. 6. During a review of Patient 6’s Home Health Certification and Plan of Care, dated 11/2/2023 to 12/31/2023, Home Health Certification and Plan of Care indicated a start of care date of 11/2/2023 with a principal diagnosis of essential (primary) hypertension (high blood pressure). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a joint home visit on 12/8/2023 at 1:15 p.m. with Licensed Vocational Nurse 1 (LVN1) to Patient 6’s home, LVN1 was unable to locate information on State and Federal funded programs in Patient 6’s HHA patient folder. 7. During a review of Patient 7’s Home Health Certification and Plan of Care, dated 4/24/2023 to 6/22/2024, the Home Health Certification and Plan of Care indicated a start of care date of 4/24/2023 with a principal diagnosis of infective dermatitis (a severe form of recurrent inflammation, redness, itching, and oozing skin change that presents in childhood). During a concurrent interview and record review on 12/7/2023 at 11 a.m. with the Administrator/Director of Patient Care Services (ADM/DPCS) of patient admission folder, ADM/DPCS was unable to locate the California State and Federal funded programs. ADM/DPCS located the Nevada State and Federal funded programs listed in the HHAs patient admission folder for their Armenia and Spanish speaking patients. During an interview on 12/7/2023, at 1:40 p.m., with ADM/DPCS, the ADM/DPCS stated California State and Federal funded program list should be provided to all patients. ADM/DPCS stated the State and Federal funded programs need to be made available to the patients, because it’s their right to have that information. A record review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, dated 2009, indicated, “Procedure: 1. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following…W. The names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: 1. Agency on Aging 2. Center for Independent Living 3. Protection and Advocacy Agency…”.

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 Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to ensure a Registered Nurse conducted initial comprehensive assessments (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for four of seven sampled patients (Patient 1, Patient 5, Patient 6, and Patient 7). (Refer to G514). 2. The HHA failed to ensure a comprehensive assessment (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for three of seven sampled patients (Patient 1, Patient 5, and Patient 6) were completed within five days of admission. (Refer to G520). 3.The HHA failed to review and document all the medications and treatments patient was receiving for one of seven sampled patients, (Patient 6). (Refer to G536). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Comprehensive Assessment of patients to ensure home health care benefits are verified for eligibility to patients provided home health services.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency failed to ensure a Registered Nurse conducted initial comprehensive assessments (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for four of seven sampled patients (Patient 1, Patient 5, Patient 6, and Patient 7). This failure resulted in a delay in assessing and determining the immediate patient care needs and interventions needed to maintain the highest practicable physical, mental, and psychosocial well-being of the patients. 1. A review of Patient 1’s medical record form titled, “Patient Information”, indicated a start of care date of 9/28/2023. The medical record did not indicate the admission diagnosis. A record review of Patient 1’s document titled, “Home Health (HH) Referrals and Orders”, dated 9/25/2023, indicated, “services needed: skilled nursing, physical therapy. For the following reasons: chronic obstructive pulmonary disease (COPD, a lung disease that makes breathing difficult), hypertension (HTN, high blood pressure), Congestive Heart Failure (CHF, heart does not pump blood well), Dementia (impaired ability to remember, think or make decisions), gastroesophageal reflux disease (GERD, stomach acid flows back to the tube connecting mouth and stomach), hypothyroidisms (low function of the thyroid), unsteady gait,… skilled nurse (SN) for evaluation, teaching on disease proves, medication management, medication compliance, home safety, blood pressure monitoring. Physical Therapy (PT) for strengthening & balance to assist with balance, coordination and strengthening of upper/lower body to maximize potential. During an interview on 12/7/2023 at 12:09 p.m., the Administrator (ADM)/Director of Patient Care Services (DPCS) stated she did not have the initial comprehensive assessment (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) completed for Patient 1. The ADM/DCPS stated there were no notes about her assessment in her medical record, both paper chart and electronic record. 2. A review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care” dated 11/19/2023 to 1/17/2024, indicated a start of care date of 11/19/2023 with a principal diagnosis of Type II diabetes mellitus with (high blood sugar). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a concurrent interview and record review on 12/7/2023 at 12:50 p.m. with the ADM/DPCS of Patient 5 electronic medical record (EMR) and physical chart, the ADM/DPCS was unable to find Patient 5’s initial nursing assessment. The ADM/DPCS stated it was important to complete and document within five days of admission to be able to provide the right treatments. The ADM/DPCS stated she took notes during Patient 5’s initial visit but was unable to find and provide the notes. 3. A review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated 11/2/2023 to 12/31/2023, indicated a start of care date of 11/2/2023 with a principal diagnosis of essential hypertension. It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a concurrent interview and record review on 12/7/2023 at 1:30 p.m. with the ADM/DPCS of Patient 6 EMR and physical chart, the ADM/DPCS stated she did not have and did not document Patient 6’s initial assessment. 4. A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 4/24/2023 to 6/22/2024, indicated a start of care date of 4/24/2023 with a principal diagnosis of infective dermatitis (a severe form of recurrent inflammation, redness, itching, and oozing skin change that presents in childhood). During a concurrent interview and record review on 12/8/2023 at 12:26 p.m. with the ADM/DPCS of Patient 7 EMR and physical chart, the ADM/DPCS stated Patient 7’s initial assessment was completed on 4/24/2023 by Registered Nurse 4 (RN4). The ADM/DPCS stated RN4 did not sign Patient 7’s initial assessment. ADM/DPCS stated RN4 needed to sign Patients 7’s initial assessment to validate her assessment is correct, informed the physician of the findings, and physician orders were received. A record review of the HHA’s policy and procedure (P&P) titled, “Admission Criteria and Process”, dated 2009, indicated, “the initial visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, or on the start of the care date ordered by the physician (doctor). The P&P also indicated; initial written assessment will be completed within 24 hours of the original assessment/admission visit. All documentation needed to develop the plan of care will be completed and turned into the office no later than the next business day.”

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency failed to ensure a comprehensive assessment (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for three of seven sampled patients (Patient 1, Patient 5, and Patient 6) were completed within five days of admission. This failure can result to patient health needs will not be identified promptly, complications, decline in health status resulting to hospitalization, and/or death. 1. A review of Patient 1’s medical record form titled, “Patient Information”, indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. A record review of Patient 1’s document titled, “Home Health (HH) Referrals and Orders”, dated 9/25/2023, indicated, services needed were skilled nursing, physical therapy due to chronic obstructive pulmonary disease (COPD, a lung disease that makes breathing difficult), hypertension (high blood pressure), Congestive Heart Failure (CHF, heart does not pump blood well), Dementia (impaired ability to remember, think or make decisions), gastroesophageal reflux disease (GERD, stomach acid flows back to the tube connecting mouth and stomach), hypothyroidisms (low function of the thyroid), unsteady gait,…skilled nurse (SN) for evaluation, teaching on disease proves, medication management, medication compliance, home safety, blood pressure monitoring. Physical Therapy (PT) for strengthening & balance to assist with balance, coordination and strengthening of upper/lower body to maximize potential. During an interview on 12/7/2023 at 12:09 p.m., the Administrator (ADM)/ Director of Patient Care Services (DPCS) stated she did not have the initial comprehensive assessment completed (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for Patient 1. The ADM/DCPS stated there were no notes about her assessment in her medical record, both paper chart and electronic record. On 12/8/2023, at 1:20 p.m., a home visit was conducted with the ADM/DPCS at Patient 1’s residence. During the visit, a plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was not observed. During an interview on 12/8/2023, at 1:21 p.m., Patient 1’s caregiver (CG 1) stated Patient 1 used oxygen due to occasional shortness of breath. CG 1 stated Patient 1 health conditions were COPD, thyroid problems, high blood pressure, heart problems, and memory problems. During a concurrent observation and interview of the home visit on 12/8/2023 at 1:25 p.m., the ADM/DPCS took Patient 1’s blood pressure. The blood pressure was 156/82 millimeters of mercury (mmHg, a unit of measurement. The normal blood pressure level range is 110/70 mmHg). The ADM/DPCS asked Patient 1 regarding her pain level. The ADM/DCPS stated Patient 1 reported a pain level of 7/10 (a pain scale used in a facility with 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-8 severe pain, 9-10 worst pain possible) to both her knees. During an interview on 12/8/2023, at 1:26 p.m., CG 1 stated Patient 1 had received physical therapy once a week. 2. A review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care”, dated 11/19/2023 to 1/17/2024, indicated a start of care date of 11/19/2023 with a principal diagnosis of Type II diabetes mellitus with (high blood sugar). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a concurrent interview and record review on 12/7/2023 at 12:50 p.m. with the ADM/DPCS of Patient 5 electronic medical record (EMR) and physical chart, the ADM/DPCS was unable to find a documented POC for Patient 5. The ADM/DPCS stated she did not complete Patient 5’s plan of care (POC) because she did not have time. The ADM/DPCS stated she was performing two roles, one in the office and the other on the field. The ADM/DPCS stated POCs are plans that need to be followed by the nurses. ADM/DPCS stated without patients’ POCs they jeopardize patient care because there is no plan to follow. ADM/DPCS stated POCs need to be completed and documented within seven days of admission. 3.A review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care”, dated 11/2/2023 to 12/31/2023, indicated a start of care date of 11/2/2023 with a principal diagnosis of essential (primary) hypertension. It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a concurrent interview and record review on 12/7/2023 at 1:30 p.m. with the ADM/DPCS of Patient 6 EMR and physical chart, the ADM/DPCS stated she did not have and did not document Patient 6’s POC. The ADM/DPCS stated “Patients need to have a POC, to give proper patient care and if I can’t go see the patient whoever does, need to know what they need to do. Also, they need to know why they are receiving HH (home health) services.” During a joint home visit on 12/8/2023 at 1:15 p.m. with License Vocational Nurse 1 (LVN1) to Patient 6’s home, LVN1 stated it was the first-time she would care for Patient 6. LVN1 stated she did not know anything about her (Patient 6). LVN1 stated Patient 6’s POC was not provided to her. LVN1 stated Patient 6’s POC was needed in the chart to know diagnoses, medications Patient 6 was taking and the care Patient 6 needed. LVN1 stated she took Patient 6’s vital signs, asked to see her medications, and assessed her pain because that is what she does with other patients. During an interview on 12/7/2023 at 10:40 a.m. with the ADM/DPCS), the ADM/DPCS stated patients’ intake, OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes), POC, physicians orders, and communication notes are in the patients EMR. The ADM/DPCS stated all other patients’ medical records are in their physical paper chart. The HHA failed to ensure an initial comprehensive assessment was completed, to identify Patient 6’s physical needs, which was needed to formulate a plan of care. A review of the home health agency’s (HHA) policy and procedure (P&P) titled, “Initial and Comprehensive Assessment”, dated 2009, indicated, the purpose was to provide guidelines for the initial assessments of patients admitted to service and for completing plans of care; the comprehensive assessment for each patient must be completed in its entirety by the same clinician; during the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record; the information gathered during the initial and comprehensive assessments will be used by the physician in developing and authorizing the plan of care. A review of HHA’s P&P titled, “Admission Criteria and Process”, dated 2009, indicated, the Clinical Supervisor will assign clinical organization personnel to conduct assessments of eligibility for services within 48 hours of acceptance of referral information and/or discharge from a referring facility, the patient’s most critical needs for home health services must be identified ruing the initial assessment, and met in a timely fashion. The P&P also indicated; a comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. Each patient must receive a patient-specific, comprehensive assessment that identifies the need for home health and that meets the patient’s medical, nursing, rehabilitative, social, and discharge planning needs.”

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 failed to review and document all the medications and treatments the patient was receiving for one of seven sampled patients, (Patient 6). This deficient practice placed the patients at risk for adverse drugs reaction and medication error. A review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care,” dated 11/2/2023 to 12/31/2023, indicated a start of care date of 11/2/2023 with a principal diagnosis of essential hypertension. It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a joint home visit and concurrent interview with LVN1 and Patient 6 on 12/8/2023 at 1:15 p.m., LVN1 stated she did not know anything about Patient 6. LVN1 stated Patient 6’s medication list was not in her HHA patient folder. Patient 6 stated she brought a lot of blood pressure medications but did not show these medicines to “the other nurse”. LVN1 told Patient 6 that she will tell the other nurse to review the medication at her next visit. LVN1 stated “usually when the Registered Nurse does the evaluation, she checks the medication.” LVN1 stated medication reconciliation was important to prevent adverse effects. During an interview on 12/7/2023 at 10:40 a.m. with the ADM/DPCS, the ADM/DPCS stated patients’ intake, OASIS, POC, physician’s orders, and communication notes were in the patients EMR. The ADM/DPCS stated all other patients’ medical records were in the physical paper chart. During a concurrent interview and record review on 12/7/2023 at 1:30 p.m. of Patient 6’s medical record, the ADM/DON stated she did not type Patient 6’s medication list. A record review of the home health agency’s policy and procedure titled, “Medication Profile”, dated 2009, indicated, patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.”

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency failed to ensure one of seven sampled patients (Patient 3), had an updated comprehensive assessment (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) during a recertification period. This deficient practice had the potential for an inaccurate assessment of the patients’ needs. A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/28/2023 to 11/26/2023, indicated a start of care day of 9/29/2023, with diagnoses including osteoarthritis (joint stiffening, swelling, causing pain or discomfort). During an interview on 12/7/2023, at 12:17 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) stated there were no notes regarding Physical Therapy (PT) for Patient 3 because she had refused PT on the week of 9/28/2023. The ADM/DPCS stated she did not have documentation that she had notified the doctor of Patient 3’s PT refusal. During a concurrent interview and record review on 12/7/2023, at 2:03 p.m., the ADM/DPCS reviewed Patient 3’s record titled, “Recertification/Follow Up Assessment, dated 11/22/2023. The record indicated Patient 3 did not refuse care services. The ADM/DPCS stated she had documented that the patient has not refused any part of the care, even though Patient 3 had refused PT. The ADM/DPCS stated the updated assessment was not accurate. Patient 3’s clinical record also indicated, care coordination with Certifying Physician (doctor), Skilled Nurse (SN), PT. The ADM/DPCS stated she had forgotten to remove PT. The ADM/DPCS stated it was important for the assessment to be accurate to show the services the patient needs. A review of the home health agency’s policy and procedure (P&P) titled, “Reassessments/Recertification”, dated 2009, indicated, a comprehensive assessment must be performed to measure patient progress toward outcomes. Any assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician. The P&P also indicated, documentation in the clinical record should support the assessment as well as actions taken in response.”

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: This CONDITION is NOT MET as evidenced by: Based on observation, 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 the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was followed for three of seven sampled patients (Patient 1, Patient 3, Patient 4). (Refer to G572). This failure had the potential to result in health status decline. 2. The HHA failed to develop a plan of care for three of seven sampled patients (Patient 1, Patient 5, and Patient 6). This failure had the potential to result in health status decline and/or hospitalization by not developing a plan of care based on the needs of the patients. (Refer to G574). 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 3, Patient 4, and Patient 7). 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 the plan of care reflected current information from the updated comprehensive assessment for one of seven sampled patients (Patient 3). This failure resulted in the patients not receiving the care as written in the plan of care. (Refer to G592) 5. The HHA failed to provide written information regarding the plan of care for three of seven sampled patients (Patient 1, Patient 5 and Patient 6). This deficient practice resulted in patients and their representatives not knowing their care team or their treatment course were ordered. (Refer to G612). 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 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 the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was followed for three of seven sampled patients (Patient 1, Patient 3, Patient 4). This failure had the potential to result in health status decline. 1.A review of Patient 1’s medical record form titled, “Patient Information”, indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. A record review of Patient 1’s document titled, “Home Health Referrals and Orders”, dated 9/25/2023, indicated, “services needed: skilled nursing, physical therapy… PT (Physical Therapy) for strengthening & balance to assist with balance, coordination and strengthening of upper/lower body to maximize potential. During an interview on 12/7/2023, at 12:06 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) stated she did not have any nursing notes as evidence Patient 1 was seen. The ADM/DPCS stated the reason there was no nursing care notes was because she was behind in documentation. The ADM/DPCS stated the only evidence she had of the nursing visits was patient testimony. During an interview on 12/7/2023, at 12:19 p.m., the ADM/DPCS stated there were no PT notes in Patient 1’s medical record because PT was waiting for a copy of the POC to release the notes. The ADM/DPCS stated she would know the frequency of PT services when PT sends the notes about the initial PT evaluation. The HHA failed to ensure there were nursing and PT visit notes as evidence the doctor’s orders were followed. 2.A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/28/2023 to 11/26/2023, indicated a start of care day of 9/29/2023, with diagnoses including ostheoarthritis (joint stiffening, swelling, causing pain or discomfort). Further review of the record indicated the skilled nurse was to visit Patient 3 once a week for one week (1wk1), twice a week for two weeks (2wk2), and once a week for six weeks thereafter (1wk6). During an interview on 12/7/2023, at 1:50 p.m., the ADM/DPCS stated there was no nursing notes in Patient 3’s medical record. The ADM/DPCS stated it was important to document visit notes in a timely manner to keep the patient’s status up to date, in case another nurse follows, she can see the progress of the patient. Visit notes were also important for team conferences, to be able to coordinate and know what was done for the patient. It validates the care provided. The ADM/DPCS stated, “what is not documented, it was not done.” The HHA failed to ensure there were nursing visit notes as evidence services were provided to Patient 3 according to the POC. 3. A record review of Patient 4’s record titled, “Home Health Certification and Plan of Care”, for certification period 5/26/2023 to 7/24/2023, indicated a start of care day of 5/26/2023, with diagnoses including a fracture (broken bone). The record indicated Physical Therapy (PT) was to evaluate the patient and follow up treatment. The skilled nurse was to see Patient 4 once a week for nine weeks (1wk9). During an interview on 12/7/2023, at 2:59 p.m., the ADM/DPCS stated there were no nursing and no PT notes in Patient 4’s medical record. The HHA failed to ensure there were nursing and PT visit notes as evidence services were provided to Patient 4 according to the POC. A record review of the HHA’s policy and procedure titled, “Care Planning Process”, dated 2009, indicated, “Policy…The care planning process will be documented on the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries… A record review of the HHA’s policy and procedure titled, “Care Coordination”, dated 2009, indicated, “Procedure…6.Contract personnel will participate in preparation of the plan of care, submit documentation on services provided, including clinical notes schedule of visits, and patient evaluations, on a weekly basis…”.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to develop a plan of care for three of seven sampled patients (Patient 1, Patient 5, and Patient 6). This failure had the potential to result in health status decline and/or hospitalization by not developing a plan of care based on the needs of the patients. 1.A review of Patient 1’s medical record form titled, “Patient Information”, indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. During an interview on 12/7/2023, at 12:03 p.m., the ADM/DCPS stated Patient 1’s plan of care (POC) was incomplete and should have been completed at the beginning of October 2023. The ADM/DPCS stated she was responsible in ensuring the POC was completed. It was important for Patient 1 to have a POC so the nurses knew what care to provide. When asked how the nurses knew what care to provide, the ADM/DPCS stated she was the only one visiting Patient 1 because she was financially struggling. During an interview on 12/7/2023, at 1:53 p.m., the ADM/DPCS stated she did not have any nursing notes because there was a water leak in the office and had to move the files. The ADM/DPCS stated, “they are somewhere here” (referring to the notes). When asked how she was keeping track of vital signs (blood pressure, pulse, respirations, temperature, pain readings giving information on how the body is doing) the ADM/DPCS stated there was a paper log in the patient’s home where she wrote the information on every visit. A record review of Patient 1’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/28/2023 to 11/26/2023, indicated “draft” written on the document. Further review of the record did not indicate information under sections titled, “Other Pertinent Diagnoses, DME (durable medical equipment) and supplies, safety measures, nutritional requirements, functional limitations, activities permitted, mental status, prognosis, orders for discipline and treatments, goals/rehabilitation, nurse’s signature and date verbal SOC were applicable, attending Physician’s signature and date signed”. During a concurrent observation and interview of the home visit on 12/8/2023 at 1:25 p.m., Surveyor observed the ADM/DPCS taking Patient 1’s blood pressure. The blood pressure results were 156/82. The ADM/DPCS asked Patient 1 if she was having pain. The ADM/DCPS stated Patient 1 reported a pain level of 7/10 (0 being no pain, 10 being the worst pain, based on scale of 0 to 10) to both her knees. During an observation of the agency folder at the home visit on 12/8/2023, at 1:35 p.m., there was no paper log with Patient 1’s vital signs information. During an interview at the home visit on 12/8/2023, at 1:40 p.m., the ADM/DPCS asked Patient 1’s caregiver (CG 1) to find the vital signs paper log. CG 1 stated she had not seen that paper and if she knew it was important, she would have it handy and look for it. During an interview on 12/8/2023, at 3:11 p.m., the ADM/DPCS stated the agency had a standard policy for reporting blood pressure parameters. If the systolic blood pressure (the measurement of pressure in the arteries when the heart beats) was more than 160 or less than 90, and the diastolic (measurement of pressure when the heart rests) was more than 90 or less than 60, the doctor would be notified unless the doctor ordered different parameters. The ADM/DPCS stated she still did not have a completed POC for Patient 1. During a concurrent interview and record review on 12/8/2023, at 3:16 p.m., the ADM/DPCS reviewed Patient 1’s record titled “History of Present Illness”, dated 9/25/2023. The ADM/DPCS stated the record indicated Patient 1’s blood pressure goal was to be 140/90. The ADM/DPCS stated Patient 1’s blood pressure was not meeting the goal, but the reading taken during the home visit (156/82) was not within the agency’s reportable range because if Patient 1 took her medication and remains under 160 (systolic) the blood pressure reading did not have to be reported. The ADM/DPCS stated she should have called the doctor to get a clarification order to see if he wants to be informed if Patient 1 is not meeting her blood pressure goals. During an interview on 12/8/2023, at 3:17 p.m., the ADM/DPCS was asked how she has been keeping track of Patient 1’s health status and progress without a POC. The ADM/DPCS stated, Patient 1’s notes were somewhere in the office. The ADM/DPCS stated she knew Patient 1’s clinical information because she had a “cheat sheet” she kept for every patient in a folder. During the survey, the ADM/DPCS was unable to show evidence of the notes she was keeping for Patient 1. The HHA failed to ensure an individualized plan of care was developed for Patient 1 that addressed her physical needs. 2.A review of Patient 5’s medical record form titled “Patient Information” indicated the start of care date of 11/19/2023. It also indicated sections: diagnosis, caregivers assigned, and certification were left blank. A review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care” indicated the start of care date of 11/19/2023 with a primary diagnosis of type 2 diabetes mellitus (high blood sugar). It also indicated sections: Medications, other pertinent diagnosis, supplies, safety measures, nutritional requirements, functional limitations, mental status, prognosis, order for disciplines and treatments, goals, and nurses’ signatures were left blank. A review of Patient 5’s medical record paper chart, the following forms were in Patient 5’s chart: Patient Information, Home Health Certification and Plan of Care, HH referrals and orders, and four consents. All four consent “Medicate Secondary Payer Questionnaire; Client Bill of Rights & Responsibilities; Home Health Provided Patient Arbitration Agreement; and Patient Consent for Treatment” had a signature under “Patient/Client Signature” and nothing else was written. During a concurrent interview and record review on 12/7/2023 at 12:50 p.m. with ADM/DPCS of Patient 5’s SS and paper chart medical record, ADM/DPCS stated she is behind on documentation due to having two roles, office, and field work. ADM/DPCS stated “the POC is a plan to follow, the nurses need to follow up on what the POC says. If there is no POC, we are jeopardizing the patient care because you need a plan to follow.” ADM/DPCS stated patients POC need to be completed and documented within seven days of admission. 3.A review of Patient 6’s medical record form titled “Patient Information” indicated the start of care date of 11/2/2023. It also indicated sections: diagnosis and certification were left blank. A review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” indicated the start of care date of 11/2/2023 with a primary diagnosis of essential primary hypertension (high blood pressure). It also indicated sections: Medications, other pertinent diagnosis, supplies, safety measures, nutritional requirements, functional limitations, mental status, order for disciplines and treatments, goals, and nurses’ signatures were left blank. A review of Patient 6’s medical record paper chart, the following forms were in Patient 6’s chart: Patient Information, Home Health Certification and Plan of Care, HH referrals and orders, Daily Activity Log, and four consents. During a concurrent interview and record review on 12/7/2023 at 1:30 p.m. with ADM/DPCS of Patient 6’s SS and paper chart medical record, ADM/DPCS stated Patient 6’s POC is not documented. ADM/DPCS stated “Patients need to have a POC, to give proper patient care and if I can’t go see the patient whoever does, need to know what they need to do. Also, they need to know why they are receiving HH services.” During a concurrent observation, interview, and record review on 12/8/2023 at 1:15 p.m. with LVN1 of Patient 6’s HHA patient folder, HHA folder did not contained Patient 6’s POC. LVN1 stated she was not provided Patient 6’s POC. LVN1 stated she took Patients 6’s vital signs, pain management, and checked her medications because that is what she does for other patients. LVN1 stated POCs indicate the type of care, diagnosis, and medications patients need. The HHA failed to ensure patients plan of care was documented and provided to patient and staff. A review of the HHA’s policy and procedure titled, “Care Planning Process”, dated 2009, 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…1.Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of treatment (485) and plans of care (all disciplines)…15. The Clinical Supervisor or designee will review the plan of care for all patients. 18. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including frequency of visits by personnel and personnel acting on behalf of the organization. B. Patient medications schedule…C. Any treatments to be administered…D. Any other pertinent instruction related to the patient’s 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 – individualized patients planned care) was reviewed and signed by a physician for three of seven sampled patients (Patient 3, Patient 4, and Patient 7). 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. 1.A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/28/2023 to 11/26/2023, indicated a start of care day of 9/29/2023, with diagnoses including ostheoarthritis (joint stiffening, swelling, causing pain or discomfort). During an interview on 12/7/2023, at 1:58 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) stated Patient 3’s plan of care (POC) was not signed by doctor. The POC needed to be signed by the 30th day from the start of care date. The ADM/DPCS stated the doctor needed to sign the POC to indicate agreement with the plan of care and services the HHA is providing. 2.A record review of Patient 4’s record titled, “Home Health Certification and Plan of Care”, for certification period 5/26/2023 to 7/24/2023, indicated a start of care day of 5/26/2023, with diagnoses including a fracture (broken bone). During an interview on 12/7/2023, at 2:01 p.m., the ADM/DPCS stated the doctor had not signed Patient 4’s POC because it was missed and had not had a chance to look at it. 3.A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 4/24/2023 to 6/22/2024, indicated a start of care date of 4/24/2023 with a principal diagnosis of infective dermatitis (a severe form of recurrent inflammation, redness, itching, and oozing skin change that presents in childhood). A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 4/24/2023 to 6/22/2023, indicated section “Signature of Physician” was left blank on page 3 of 5. During an interview on 12/7/2023 at 10:40 a.m. with the Administrator/Director of Patient Care Services (ADM/DPCS), ADM/DPCS stated patients’ intake, OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes), plan of care (POC – individualized care planned for patients), physicians orders, and communication notes are in the patients Electronic Medical Record (EMR). ADM/DPCS stated all other patients’ medical records are in their physical paper chart. A review of the HHA’s policy and procedure titled, “Physician Participation in Plan of Care”, dated 2009, indicated, “Procedure…5. The attending physician (doctor) will sign the plan of care/treatment within 30 days of the star of care…”.

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 observation, interview, and record review, the Home Health Agency (HHA ) failed to ensure the plan of care reflected current information from the updated comprehensive assessment for one of seven sampled patients (Patient 3). This failure resulted in the patients not receiving the care as written in the plan of care. A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 11/27/2023 to 1/25/2024, indicated a start of care day of 9/29/2023, with diagnoses including ostheoarthritis (joint stiffening, swelling, causing pain or discomfort). The record indicated Patient 3 was receiving Physical Therapy (PT). During an interview on 12/7/2023, at 12:17 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) stated there was no notes regarding PT for Patient 3 because she had refused PT. The ADM/DPCS stated she did not have documentation that she had notified the doctor of Patient 3’s refusal of PT. During an interview on 12/7/2023, at 2:03 p.m., the ADM/DPCS stated Patient 3 had refused PT on the week of 9/28/2023. During a concurrent interview and record review on, 12/7/2023, at 2:08 p.m., the ADM/DPCS reviewed Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 11/27/2023 to 1/25/2024. The record indicated Physical Therapy (PT) was to evaluate Patient 3 and follow up treatment. Continued review of the record indicated orders, “PT: Physical therapy to determine the patient’s condition, establish home exercise program and physical therapy plans, rehabilitation potential and improve safety to increase functional independence.” The ADM/DPCS stated she had not reviewed the POC for accuracy. The POC needed to be accurate to ensure the HHA had the right treatment plan and services the patient needs. The potential outcome of an inaccurate POC was a treatment plan that was not followed. A record review of the HHA’s policy and procedure titled, “Admission Criteria and Process”, dated 2009, indicated, “Procedure…12. Refusal of services will be documented in the clinical record. Notification of the Clinical Supervisor, physician (doctor), and referral source will follow with appropriate documentation in the clinical record.

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 observation, interview, and record review the Home Health Agency (HHA) failed to provide written information regarding the plan of care for three of seven sampled patients (Patient 1, Patient 5, and Patient 6). This deficient practice resulted in patients and their representatives not knowing their care team or their treatment course were ordered. 1. A review of Patient 1’s medical record form titled, “Patient Information”, indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. On 12/8/2023, at 1:20 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) conducted a home visit at Patient 1’s residence. During the visit, a plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was not observed. During an interview on 12/8/2023, at 1:35 p.m., Patient 1’s caregiver (CG 1) stated she did not have a copy of the POC. 2.A review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care” dated 11/19/2023 to 1/17/2024, indicated a start of care date of 11/19/2023 with a principal diagnosis of Type II diabetes mellitus with (high blood sugar). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a concurrent interview and record review on 12/7/2023 at 12:50 p.m. with the ADM/DPCS of Patient 5 EMR and physical chart, ADM/DPCS was unable to find a documented POC for Patient 5. ADM/DPCS stated she did not complete Patient 5’s POC because she did not have time. ADM/DPCS stated she was performing two roles, one in the office and the other on the field. ADM/DPCS stated POCs are plans that need to be followed by the nurses. ADM/DPCS stated without patients POCs they jeopardize patient care because there is no plan to follow. ADM/DPCS stated POCs need to be completed and documented within seven days of admission. During a telephone interview on 12/8/2023 at 3:04 p.m. with Patient 5, Patient 5 stated he has been receiving HHA services for a “couple of months”. Patient 5 sated an HHA nurse visits him “once a week, or a little bit after a week.” 3.A review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated 11/2/2023 to 12/31/2023, indicated a start of care date of 11/2/2023 with a principal diagnosis of essential (primary) hypertension (high blood pressure). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. During a concurrent interview and record review on 12/7/2023 at 1:30 p.m. with the ADM/DPCS of Patient 6 EMR and physical chart, ADM/DPCS stated she did not have and did not document Patient 6’s POC. ADM/DPCS stated “Patients need to have a POC, to give proper patient care and if I can’t go see the patient whoever does, need to know what they need to do. Also, they need to know why they are receiving HH (home health) services.” During a joint home visit on 12/8/2023 at 1:15 p.m. with License Vocational Nurse 1 (LVN1) to Patient 6’s home, LVN1 stated it was the first-time meeting Patient 6 and did not know anything about her. LVN1 stated Patient 6’s POC was not provided to her, therefore was unable to read up on her. LVN1 stated Patient 6’s POC was needed to know her care, diagnoses, and medications. LVN1 stated she took Patient 6’s vital signs, asked to see her medications, and assessed her pain because that is what she does with other patients. During an interview on 12/7/2023 at 10:40 a.m. with the Administrator/Director of Patient Care Services (ADM/DPCS), ADM/DPCS stated patients’ intake, OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes), plan of care (POC – individualized care planned for patients), physicians orders, and communication notes are in the patients Electronic Medical Record (EMR). ADM/DPCS stated all other patients’ medical records are in their physical paper chart. A record review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, dated 2009, indicated, “Procedure: 1. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following:…C. The goals of care, the interventions that support those goals and the identification of the staff providing service…J. The establishment and revision of the plan of care, including the disciplines that will furnish the care and the frequency of visits as well as any changes in the care to be furnished. A review of the HHA’s policy and procedure titled, “Care Planning Process”, dated 2009, indicated, “Policy... 18. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including frequency of visits by personnel and personnel acting on behalf of the organization. B. Patient medications schedule…C. Any treatments to be administered…D. Any other pertinent instruction related to the patient’s care…”.

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 Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home), failed to ensure Condition of Participation (conditions that healthcare organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities]) for Organization and Administration of Services was met. The HHA failed to ensure the agency’s Administrator/Director of Patient Care Services (ADM/DPCS) and or a qualified designee provided the day-to-day operations of the agency and patient care oversight for three of seven sampled patients (Patient 1, Patient 5, and Patient 6) by failing to: 1. Ensure the ADM/DPCS conducted the initial assessment to determine the immediate care and support needs for Patient 1, Patient 5, and Patient 6, within five days from admission. 2. Ensure the ADM/DPCS developed a plan of care (POC, an individualized plan indicating a patient’s health condition, specific care needs, and current treatments). for Patient 1, Patient 5, and Patient 6 within seven days from admission. The noncompliance had the potential to cause delayed care and delayed and/or missed care, resulting in hospitalization by not assessing/identifying the needs of Patient 1, Patient 5, and Patient 6. (Refer to G958) The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (rules or law) mandated compliance with the Federal (government) regulations for Organization and Administration of Services to ensure the highest practicable functional capacity, including optimal care and services to meet patients' care goals. .

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 an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the agency’s Administrator/Director of Patient Care Services (ADM/DPCS) and or a qualified designee provided the day-to-day operations of the agency and patient care oversight for three of seven sampled patients (Patient 1, Patient 5, and Patient 6) by failing to: 1. Ensure the ADM/DPCS conducted the initial assessment to determine the immediate care and support needs for Patient 1, Patient 5, and Patient 6, within five days from admission. 2. Ensure the ADM/DPCS developed a plan of care (POC, an individualized plan indicating a patient’s health condition, specific care needs, and current treatments). for Patient 1, Patient 5, and Patient 6 within seven days from admission. These deficient practices had the potential to cause delayed and/or missed care, resulting in hospitalization by not assessing/identifying the needs of Patient 1, Patient 5, and Patient 6. On 12/8/2023, at 3:54 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the ADM/DPCS, and the Intake Coordinator (IC), for the HHA failure to ensure the ADM/DPCS and or a qualified designee provided the day-to-day operations of the agency and patient care oversight for three of seven sampled patients (Patient 1, Patient 5, and Patient 6). On 12/9/2023, 11:24 a.m., at the agency submitted an IJ removal Plan and was not accepted. On 12/10/2023, at 9:52 a.m., the agency submitted an IJ removal Plan and was not accepted. On 12/10/2023, at 12:30 p.m., the survey team completed the survey tasks, and exited with the Immediate Jeopardy not removed. Findings: During an interview on 12/6/2023, at 10:55 a.m., with the Office Clerk (OC), the OC stated the ADM/DPCS was out of town. During a telephone interview on 12/6/2023, at 10:58 a.m., with the ADM/DPCS, the ADM/DPCS stated the ADM designee (AD) and the DPCS designee (DD) were the same person and would contact him. During a telephone interview on 12/6/2023, at 11:03 a.m., the ADM/DPCS stated she was unable to reach the AD/DD. The ADM/DPCS stated she would travel back into town and requested the survey team to come back the next day on 12/7/2023. The ADM/DPCS was explained the survey was to commence that day. The OC then stated he was unable to provide any documents to the survey team after he spoke, he spoke with the ADM/DPCS. During an interview on 12/6/2023, at 12:15 p.m., Registered Nurse 1 (RN 1) stated she was hired at the HHA on 11/15/2023 and currently did not have any assigned HHA patients. RN1 stated she was unable to conduct or answer questions because she was new to the HHA. During an interview on 12/6/2023, at 12:47 p.m., RN3 stated she was not knowledgeable about the HHA’s operations. During an interview on 12/6/2023, at 2:13 p.m., RN2 stated she was not an “office nurse,” and she was in hurry “to go pick up my son.” During a telephone interview on 12/6/2023, at 4:11 p.m., the ADM/DPCS was asked if there was an HHA representative that would be able to run the facility during her absence. The ADM/DPCS stated “At this moment I am the only one, other than my designee; I can’t get ahold of him. I left several messages, and he has not gotten back to me.” During an interview on 12/7/2023, at 10:30 a.m., with the ADM/DPCS, the ADM/DPCS stated the AD/DD was out of the country due to a family emergency. The ADM/DPCS stated the AD/DD did not notify her of his departure. a. During a review of Patient 1’s Patient Information record, the Patient Information record indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. During a review of Patient 1’s Home Health (HH) Referrals and Orders, dated 9/25/2023, the HH Referrals and Orders indicated the services needed included skilled nursing and physical therapy (PT, include certain exercises, massages and treatments based on physical stimuli) for the following reasons: chronic obstructive pulmonary disease (COPD lung disease that makes breathing difficult), hypertension (HTN, high blood pressure), and dementia (loss of memory and other mental abilities severe enough to interfere with daily life). The HH Referrals and Orders indicated for the SN (skilled nurse) to evaluate, teach on disease process, medication management, medication compliance, home safety, and blood pressure monitoring. During an interview on 12/7/2023, at 12:03 p.m., with the ADM/DCPS, the ADM/DPCS stated Patient 1’s plan of care (POC) was incomplete and should have been completed within seven days from when Patient 1 was admitted. The ADM/DPCS stated she was responsible for ensuring the POC was developed. The ADM/DPCS stated it was important for Patient 1 to have a POC so the nurses in general knew what care to provide. The ADM/DPCS stated she was the only one who visited Patient 1 because she was financially struggling. During an interview on 12/7/2023, at 12:06 p.m., with the ADM/DPCS, the ADM/DPCS, stated she did not have any nursing notes to indicate Patient 1 was visited. During an interview on 12/7/2023, at 12:09 p.m., with the ADM/DPCS, the ADM/DPCS stated she did not have the initial comprehensive assessment for Patient 1. The ADM/DCPS stated there were no notes regarding the initial assessment in Patient 1’s medical record, both paper chart and electronic record. During an interview on 12/8/2023, at 3:17 p.m., with the ADM/DPCS, the ADM/DPCS stated she unable to show evidence that she (ADM/DPCS) oversaw Patient 1’s overall care. b. During a review of Patient 5’s Patient Information, the Patient Information indicated the start of care date of 11/19/2023. The Patient Information indicated the sections for diagnosis, caregivers assigned, and the certification were blank. During a review of Patient 5’s Home Health Certification and Plan of Care record, the Home Health Certification and Plan of Care record indicated the start of care date of 11/19/2023 with a primary diagnosis of type 2 diabetes mellitus (a medical condition characterized by the body's inability to regulate blood sugar levels). The Home Health Certification and Plan of Care record indicated the sections for medications, other pertinent diagnosis, supplies, safety measures, nutritional requirements, functional limitations, mental status, prognosis, order for disciplines and treatments, goals, and nurses’ signatures were blank. During an interview on 12/7/2023, at 12:50 p.m., with the ADM/DPCS, the ADM/DPCS stated there was no initial nursing assessment for Patient 5. The ADM/DPCS stated “I don’t have anything at all.” The ADM/DPCS stated “It’s important to have it completed within five days, so the right treatments are being implemented and needed to be completed within five days of admission.” The ADM/DPCS stated there was no POC for Patient 5. The ADM/DPCS stated if Patient 5 did not have a POC, it would jeopardize Patient 5’s care. c. During a review of Patient 6’s Patient Information, the Patient Information indicated the start of care date of 11/2/2023 and the sections for diagnosis and certification were blank. During a review of Patient 6’s Home Health Certification and Plan of Care, the Home Health Certification and Plan of Care indicated the start of care date of 11/2/2023 with a primary diagnosis of essential primary hypertension (high blood pressure). The Home Health Certification and Plan of Care indicated the sections of medications, other pertinent diagnosis, supplies, safety measures, nutritional requirements, functional limitations, mental status, order for disciplines and treatments, goals, and nurses’ signatures were blank. During a concurrent interview on 12/7/2023, at 1:30 p.m., with the ADM/DPCS, the ADM/DPCS stated she did not do Patient 6’s initial nursing assessment and did not develop a plan of care. ADM/DPCS stated “I don’t have it right now.” A review of the HHA’s policy and procedure titled, “Designation of Individual in Absence of Executive Director/Administrator”, dated 2009, indicated, “Policy Angel Home Health Services, Inc will have an Executive Director/Administrator or designee available at all times. Procedure: 1. In the event that the Executive Director/Administrator is absent, the Clinical Director will assume the operational duties and responsibilities…2.In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. 3. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence”. The record did not indicate the individuals under section 3. A review of the HHA’s policy and procedure titled, “Responsibilities/Supervision of Clinical Services”, dated 2009, indicated, “Policy: Supervision of clinical care and services will be available 24 hours a day, seven (7) days a week…The Clinical Director will be responsible for the clinical direction of the organization and will take reasonable steps to ensure that:…3.Policies and procedures, which guide and support the provision of care and services, are developed and implemented…Procedure: 1. The Clinical Director will oversee the day-to-day clinical operations…”. A review of HHA’s policy and procedure titled , “Admission Criteria and Process”, dated 2009, indicated, “Procedure…2. The Clinical Supervisor will assign clinical organization personnel to conduct assessments of eligibility for services within 48 hours of acceptance of referral information and/or discharge from a referring facility…B. The patient’s most critical needs for home health services bust be identified ruing the initial assessment and met in a timely fashion….17. A comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. A. Each patient must receive a patient-specific, comprehensive assessment that identifies the need for home health are and that meets the patient’s medical, nursing, rehabilitative, social, and discharge planning needs. A review of the HHA’s policy and procedure titled, “Initial and Comprehensive Assessment”, dated 2009, indicated, “Procedure…2. The comprehensive assessment for each patient must be completed in its entirety by the same clinician…4.During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record…6. Information gathered during the initial and comprehensive assessments will be used by the physician in developing and authorizing the plan of care. 7. The Clinical Supervisor or designee will be responsible for the review of the plan of care.” A review of the HHA’s policy and procedure titled, “Care Planning Process”, dated 2009, 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…1.Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. Documents include plan of treatment (485) and plans of care (all disciplines) …15. The Clinical Supervisor or designee will review the plan of care for all patients. 18. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including frequency of visits by personnel and personnel acting on behalf of the organization. B. Patient medications schedule…C. Any treatments to be administered…D. Any other pertinent instruction related to the patient’s care…”.

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: 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 Home Health Agency (HHA) failed to ensure clinical records reflected the care for six of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, and Patient 6). (Refer to G1012). 2. The HHA failed to ensure two of seven sampled patients (Patient 3 and Patient 7) clinical records indicated the author of the note. (Refer to G1024). This failure resulted in incomplete medical records that have potential for the patients not receiving the necessary care/services as in accordance with the patients' plan of care. 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 interview and record review the Home Health Agency (HHA) failed to ensure clinical records reflected the care for six of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, and Patient 6). This failure resulted in incomplete clinical records that have potential for the patients not receiving the necessary care/services as in accordance with the patients' plan of care. 1.A review of Patient 1’s medical record form titled, “Patient Information”, indicated the start of care date of 9/28/2023. The record did not indicate the admission diagnosis. A record review of Patient 1’s document titled, “HH Referrals and Orders”, dated 9/25/2023, indicated, “services needed: skilled nursing, physical therapy… PT (Physical Therapy) for strengthening & balance to assist with balance, coordination and strengthening of upper/lower body to maximize potential. During an interview on 12/7/2023, at 12:06 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) stated she did not have any nursing notes as evidence Patient 1 was seen. The ADM/DPCS stated the reason there was no nursing care notes because she was behind in documentation. The ADM/DPCS stated the only evidence she had of the nursing visits was patient testimony. During an interview on 12/7/2023, at 12:19 p.m., the ADM/DPCS stated there were no PT notes in Patient 1’s medical record because PT was waiting for a copy of the POC to release the notes. The ADM/DPCS stated she would know the frequency of PT services when PT sends the notes about the initial PT evaluation. There was no documentation that Patient 1’s clinical records reflected the care received. 2. A record review of Patient 2’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/18/2023 to 11/16/2023, indicated a start of care day of 9/18/2023, with diagnoses including post procedural pain. During an interview on 12/7/2023. At 2:29 p.m., the ADM/DPCS was discharged on 10/11/2023 because he was refusing nursing services and the goals were met. The ADM/DPCS stated there was no discharge order, no documentation the doctor was notified that he did not want skilled nursing services, and no documentation about his discharge. The ADM/DPCS stated she would follow up with Physical Therapy about the discharge. There was no documentation that Patient 2’s clinical records reflected the discharge order and discharge events. 3.A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/28/2023 to 11/26/2023, indicated a start of care day of 9/29/2023, with diagnoses including osteoarthritis (joint stiffening, swelling, causing pain or discomfort). Further review of the record indicated the skilled nurse was to visit Patient 3 once a week for one week (1wk1), twice a week for two weeks (2wk2), and once a week for six weeks thereafter (1wk6). During an interview on 12/7/2023, at 1:50 p.m., the ADM/DPCS stated there was no nursing notes in Patient 3’s medical record. The ADM/DPCS stated it was important to document visit notes in a timely manner to keep the patient’s status up to date, in case another nurse follows, she can see the progress of the patient. Visit notes were also important for team conferences, to be able to coordinate and know what was done for the patient. It validates the care provided. The ADM/DPCS stated, “what is not documented, it was not done.” There was no documentation that Patient 3’s clinical records reflected the care received. 4. A record review of Patient 4’s record titled, “Home Health Certification and Plan of Care”, for certification period 5/26/2023 to 7/24/2023, indicated a start of care day of 5/26/2023, with diagnoses including a fracture (broken bone). The record indicated Physical Therapy (PT) was to evaluate the patient and follow up treatment. The skilled nurse was to see Patient 4 once a week for nine weeks (1wk9). During an interview on 12/7/2023, at 2:59 p.m., the ADM/DPCS stated there were no nursing and no PT notes in Patient 4’s medical record. There was no documentation that Patient 4’s clinical records reflected the care received. 5.A review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care” dated 11/19/2023 to 1/17/2024, indicated a start of care date of 11/19/2023 with a principal diagnosis of Type II diabetes mellitus with (high blood sugar). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. A review of Patient 5’s medical record form titled “HH Referrals and Orders” undated, indicated there was no ordered Skilled Nurse (SN) visit frequency ordered. It also indicated “PT (physical therapy) for strengthening and balance to assist with balance…” During a concurrent interview and record review on 12/7/2023 at 12:50 p.m. with the ADM/DPCS of Patient 5 EMR and physical chart, ADM/DPCS was unable to find any of Patient 5’s skilled nurse visit notes. ADM/DPCS stated she saw Patient 5 on Monday and that his skilled nursing visit frequency was not documented in his medical record. ADM/DPCS stated she documented her visit notes but is unable to find them. ADM/DPCS stated “I don’t know where they are. I would need to look for them.” ADM/DPCS stated visit notes were needed to keep Patient 5’s cares up to date and provide patient information to the HHA team. ADM/DPCS stated “If it’s not documented it hasn’t been done.” During a concurrent interview and record review on 12/8/2023 at 3:25 p.m. with the ADM/DPCS of Patient 5’s medical record, ADM/DPCS stated there were no Physical Therapist (PT) notes because they were not sent by PT yet. ADM/DPCS stated PT is waiting for Patient 5’s POC to send their notes. There was no documentation that Patient 5’s clinical records reflected the care received. 6.A review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated 11/2/2023 to 12/31/2023, indicated a start of care date of 11/2/2023 with a principal diagnosis of essential (primary) hypertension (high blood pressure). It also indicated sections “other pertinent diagnoses, functional limitations, medications, supplies, safety measures, allergies, nutritional requirements, mental status, orders for disciplines and treatments, goals, nurses’ signatures, and attending physician signature” were left blank. A review of Patient 6’s medical record form titled “HH Referrals and Orders” undated, indicated there was no ordered Skilled Nurse (SN) visit frequency ordered. It also indicated “PT (physical therapy) for strengthening and balance to assist with balance…” During a concurrent interview and record review on 12/7/2023 at 1:30 p.m. with the ADM/DPCS of Patient 6 EMR and physical chart, ADM/DPCS stated she did not have and did not document Patient 6’s POC. ADM/DPCS stated “Patients need to have a POC, to give proper patient care and if I can’t go see the patient whoever does, need to know what they need to do. Also, they need to know why they are receiving HH (home health) services.” During a concurrent interview and record review on 12/8/2023 at 3:20 p.m. with the ADM/DPCS of Patient 6’s medical record, ADM/DPCS stated there were no Physical Therapist (PT) notes because they were not sent by PT yet. ADM/DPCS stated PT required patients POC before sending their notes. During an interview on 12/7/2023 at 10:40 a.m. with the Administrator/Director of Patient Care Services (ADM/DPCS), ADM/DPCS stated patients’ intake, OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes), plan of care (POC – individualized care planned for patients), physicians orders, and communication notes are in the patients Electronic Medical Record (EMR). ADM/DPCS stated all other patients’ medical records are in their physical paper chart. There was no documentation that Patient 6’s clinical records reflected the care received. A record review of the HHA’s policy and procedure titled, “Entries into the Clinical Record”, dated 2009, indicated, “Procedure: 1. A clinical record will be initiate and maintained for each patient receiving care or services, according to organization policies found in this manual, and will include at a minimum…E. Dates, times, and types of interventions, assessments, and coordination of care…6.Entries into the clinical record will be made on the day care is provided to the patient. All documentation will be turned in to the office at the end of the workday and clinical notes dictated or written will be incorporated into the patient’s health record at least every seven calendar days.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure two of seven sampled patients (Patient 3 and Patient 7) clinical records indicated the author of the note. This failure resulted in incomplete medical records that have potential for the patients not receiving the necessary care/services as in accordance with the patients' plan of care. 1.A record review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 11/27/2023 to 1/25/2024, indicated a start of care day of 9/29/2023, with diagnoses including ostheoarthritis (joint stiffening, swelling, causing pain or discomfort). During a concurrent interview and record review on 12/7/2023, at 2:01 p.m., the Administrator/Director of Patient Care Services (ADM/DPCS) reviewed Patient 3’s record titled, “Recertification/Follow Up Assessment”, dated 11/22/2023. The ADM/DPCS stated the document was not signed nor did it indicate the author of the note. The ADM/DPCS stated the purpose of signing the document was to indicate an agreement on what the nurse is assessing and signing. During a concurrent interview and record review on 12/7/2023, at 2:01 p.m., the ADM/DPCS reviewed Patient 3’s record titled, “Comprehensive Adult Nursing Assessment”, dated 9/28/2023. The ADM/DPCS stated the document was not signed. The HHA failed to ensure Patient 3’s clinical records were authenticated by the author of the note. 2.A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated 4/24/2023 to 6/22/2024, indicated a start of care date of 4/24/2023 with a principal diagnosis of infective dermatitis (a severe form of recurrent inflammation, redness, itching, and oozing skin change that presents in childhood). During a concurrent interview and record review on 12/8/2023 at 12:26 p.m. with the ADM/DPCS of Patient 7 EMR and physical chart, ADM/DPCS stated Patient 7’s initial assessment was completed on 4/24/2023 by Registered Nurse 4 (RN4). ADM/DPCS stated RN4 did not sign Patient 7’s initial assessment. ADM/DPCS stated RN4 needed to sign Patients 7’s initial assessment to validate her assessment is correct, informed the physician of the findings, and physician orders were received. The HHA failed to ensure Patient 7’s clinical records were authenticated by the author of the note. A record review of the HHA’s policy and procedure titled, “Contents of the Clinical Record”, dated 2009, indicated, “Procedure: 1. The following information will be available in the clinical record, as applicable to care and services provided…L. Notes for each service provided, indicating date, organization personnel and care provided.” A record review of the HHA’s policy and procedure titled, “Entries into the Clinical Record”, dated 2009, indicated, “Procedure: 1. A clinical record will be initiate and maintained for each patient receiving care or services, according to organization policies found in this manual, and will include at a minimum:…7. The clinical note will include…E. Signature of clinician and his/her credentials.”