Libertana Home Health of Sherman Oaks

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs) for Care Planning, Coordination of services, and Quality of care was met as follows: 1. The Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to provide the care and services according to the patient’s written plan of care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), for two of seven sampled patients (Patient 6 and 7). These failures had the potential to result in poor patient care outcomes related to medication errors (any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of a healthcare provider, patient, or consumer), adverse drug reactions (an undesired effect of a drug or other type of treatment, such as surgery, and can range from mild to life-threatening), poor adherence to medication regimen, increased risk of complications from existing medical conditions, and existing wounds to further decline and not resolve. Refer to G572. 2. The Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the responsible physician was notified regarding patients’ noncompliance with their plans of care for two of seven sampled patients (Patient 6 and 7). These failures had the collective potential to result in Patient 6 and Patient 7’s medical conditions to worsen, due to a lack of informed medical supervision, a lack of comprehensive intervention, and an increased risk of medical complications due to unattended patient noncompliance. Refer to G590. 3. The Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to revise the plan of care (a document detailing a patient’s health needs, created by a healthcare team based on the comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) to reflect clinical information identifying the patient’s progress toward the measurable outcomes and goals for one of seven sampled patients (Patient 3). This deficient practice had the potential to affect the HHA’s ability to meet the patient’s identified needs. Refer toG592. The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with federal regulation for care planning, coordination of services, and quality of care to ensure quality patient care was provided to the patients receiving the Medicare home health benefits.”

“Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This Condition is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs) on Clinical Records was met as follows: 1. The Home Health Agency (HHA) failed to ensure the patients’ clinical records contained completed comprehensive assessment, plan of care, and clinical notes identifying documented evidence of blood sugar monitoring and wound care management for two of 7 sampled patients (Patients 3 and 6). This deficient practice resulted to an incomplete clinical records leading to misinformation and non-continuity of care and services to be provided to these patients certified to receive the Medicare home health benefits. Refer to G1012. 2. The Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure that all interventions, including medication administration, treatments, services, and patient responses to those interventions were documented for three of seven sampled patients (Patient 3 and Patient 7). This deficient practice had the potential to result for these certified patients will not be provided the care and services identified in the plans of care that could affect their health status and wellbeing. Refer to G1014. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with the federal regulations for Clinical Records to ensure the clinical records contained accurate and completed clinical information to all patients certified to receive the Medicare home health benefits. 1. The Home Health Agency (HHA) failed to ensure the patients’ clinical records contained completed comprehensive assessment, plan of care, and clinical notes identifying documented evidence of blood sugar monitoring and wound care management for two of 7 sampled patients (Patients 3 and 6). This deficient practice resulted to an incomplete clinical records leading to misinformation and non-continuity of care and services to be provided to these patients certified to receive the Medicare home health benefits. Refer to G1012. 2. The Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure that all interventions, including medication administration, treatments, services, and patient responses to those interventions were documented for three of seven sampled patients (Patient 3 and Patient 7). This deficient practice had the potential to result for these certified patients will not be provided the care and services identified in the plans of care that could affect their health status and wellbeing. Refer to G1014. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with the federal regulations for Clinical Records to ensure the clinical records contained accurate and completed clinical information to all patients certified to receive the Medicare home health benefits.”

“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 observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to provide the care and services according to the patient’s written plan of care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), for two of seven sampled patients (Patient 6 and 7) by failing to: 1) Perform medication management and wound care management for Patient 6. 2) Perform patient medication management (refers to the comprehensive process of overseeing and coordinating all aspects of a patient’s medication regimen, which includes reviewing medications, identifying potential interactions, ensuring correct dosage, monitoring for side effects, educating patients, promoting adherence, and adjusting treatment) for Patient 7. These failures had the potential to result in poor patient care outcomes related to medication errors (any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of a healthcare provider, patient, or consumer), adverse drug reactions (an undesired effect of a drug or other type of treatment, such as surgery, and can range from mild to life-threatening), poor adherence to medication regimen, increased risk of complications from existing medical conditions, and existing wounds to further decline and not resolve. 1. During a review of Patient 6’s “Client Profile,” dated 2/11/2025, the “Client Profile” indicated, Patient 6 was admitted to the HHA on 05/01/2018. During a review of Patient 6’s “RN Recert,” dated 7/25/2024, the “RN Recert” indicated the following for Patient 6: “she monitors her BS (blood sugar) with DExcomG7 and changes every 10 days, however patient did not have it on during the visit, stating she, will put it on later. RN offered to install it; however patient declined the help. Patient uses Omnipod 5 (A wearable tubeless insulin delivery system that automatically adjusts insulin based on glucose levels) for insulin administration. Wound (has wound to the right lower leg) from the past 3 months has increased redness surrounding the 2-dime size open wounds with small amount of clear drainage. Patient does not dress the wound. Patient is noncompliant with her hygiene and keeping the area clean.” During a further review of Patient 6’s “RN Recert,” dated 7/25/2024, the “RN Recert” further indicated, Patient 6’s wounds did not have wound measurements nor wound treatments, and the individuals responsible for performing Patient 6’s wound care were not indicated. No coordination of care was documented between the Director of Patient Care Services Designee (DPCSD), the Director of Patient Care Services (DPCS), the Clinical Care Agency (CCA), nor the responsible physician regarding Patient 6’s noncompliance with their BS management and worsened wound. There was no plan of care (POC) developed based on the RN recertification assessment for wound management conducted on 7/25/2024. During a review of Patient 6’s “RN Supervisory Visit,” dated 8/29/24, the “RN Supervisory Visit” indicated, Patient 6 “has 1+ pitting edema (pitting edema occurs when swelling is caused by a buildup of fluids, usually in the lower body) to RLE (right lower extremity). Patient refused to give any information regarding BS reading. Patient states, she monitors her BS with DexcomG7 and changes every 10 days, however patient did not have it on during the visit, stating she will have it on later. RN offered to install it; however, patient declined the help. Patient used Omnipod 5 for insulin administration. Patient 6 did not have it on and refused for any help. Wound has increased redness/purple surrounding the 2-dime size open wounds. Patient is not compliant with hygiene. However, patient did not reach out to MD with wound concerns states she was on antibiotics a month ago. However, wound appears worse than a month ago. Patient is not compliant in keeping the area clean.” During a further review of Patient 6’s “RN Supervisory Visit,” dated 8/29/24, the “RN Supervisory Visit” further indicated, Patient 6’s wounds did not have wound measurements nor wound treatments, and the individuals responsible for performing Patient 6’s wound care were not indicated. No coordination was documented between the DPCSD, the DPCS, nor the CCA regarding Patient 6’s noncompliance with their BS checks and worsened wound status. The documented coordination with the physician did not include the physician’s name nor what was communicated. During a review of Patient 6’s “LVN Hour,” dated 9/16/24, “LVN Hour” indicated, “… Patient is also requesting for PT (physical therapy) and wound care.” Licensed Vocational Nurse 2 (LVN 2) had documented that she would follow-up with Patient 6’s primary physician and CCA, but no care coordination was documented by LVN 2 for Patient 6. During a review of Patient 6’s “RN Recert,” dated 1/22/25, the “RN Recert” indicated, Patient 6 had a primary diagnosis of Type 1 diabetes mellitus (DM Type I – an autoimmune disorder that destroys insulin-producing tissues in the body, leading to an insulin insufficiency that can cause excess blood sugar) with diabetic neuropathy (nerve damage caused by uncontrolled high blood sugar from DM), as well as essential (primary) hypertension (HTN – also known as high blood pressure, a chronic disease that includes excess pressure within the blood vessels), depression (a mental health condition), and left-side below the knee amputation. During a concurrent observation, interview, and record review on 2/12/25 at 3 p.m., with the DPCSD and Patient 6, in Patient 6’s apartment during a home visit, the following were noted: -There were medications documented for Patient 6 that were no longer taken. Patient 6 also stated she was taking medications that were not documented in the clinical record. -Patient 6 stated, she was not taking the following medications that were included in her clinical record: Bystolic (Nebivolol, a medication that treats HTN), Metformin (medication used to treat DM), metoprolol (Medication used to treat HTN), calcium carbonate (dietary supplement for calcium intake), Norco (Narcotic pain medication), and Percocet (Narcotic pain medication). These medications remained listed on Patient 6’s medication list. - Patient 6 stated, she was taking Wellbutrin (Bupropion – used to treat depression) 450 mg (milligram, a unit of measurement [150 mg and 300 mg]), ibuprofen (an anti-inflammatory pain medication) as needed, diphenhydramine (also known as Benadryl, a medication used to treat symptoms of allergy) as needed, and Zoloft (used to treat depression). These medications were not listed on Patient 6’s medication list. - Patient 6 stated, she used a DexcomG7 for BS monitoring and administered insulin via an Omnipod 5, but neither device was in her possession. During an interview on 2/14/25 at 11:30 a.m., with the DPCSD stated, “If a patient is refusing care, like vital signs, blood sugar checks, administration of medications, wound assessment, documentation is necessary about the refusal, risks and benefits about knowing the decline of the service. They are encouraged to call the staff if they change their mind about the refusal, like site managers, or tech, any phone call to [Name of Public Subsidized Housing Program Manager (PSH Program Manager)]. Inform the caregiving staff. Report to CCA, it depends on the client, they can choose their own agency. Refusal of care should be coordinated with RN, CCA and should be called to MD (physician).” The DPCSD further stated, the nurses were not doing any wound measurements, and the nurses were supposed to measure wounds, including taking a picture. The DPCSD further stated, nurses were not assessing wounds like they’re supposed to, and no clinical supervision was being done knowing Patient 6 was noncompliant with her blood sugar checks and administering her own insulin. The DPCSD further stated, part of the reason for Patient 6’s noncompliance was because Patient 6 couldn’t see well due to her glasses being broken. During a review of the facility’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” dated April 2019, the P&P indicated, “Staff members providing care to the patients will coordinate care with other organizations, agencies, and/or individual specific to each Department’s Licensing Agency regulations and requirements. All conversations, referrals, and cooperative plans are to be documented in the patient’s clinical records.” 2. During a review of Patient 7’s “Patient Profile,” dated 10/15/2024, indicated Patient 7 was admitted to the HHA on 10/16/2024, with a primary diagnosis of Type 2 diabetes mellitus (a chronic disease that occurs when the body does not produce or use insulin properly, resulting in high blood sugar levels) with diabetic nephropathy (a complication of diabetes mellitus that damages the kidneys). During a review of Patient 7’s “LVN Hour,” dated 12/16/2024, 1/6/2025, 1/13/2025, and 1/27/2025, the “LVN Hour” indicated, “Patient 7 is oriented to person, place, and time.” During a review of Patient 7’s “Home Health Certification and Plan of Care (POC),” for the certification period of 12/15/2024 to 2/12/2025, the “POC” indicated the following: Skilled Nursing (SN - refers to licensed nurses, in general) visit frequency (0-4) hours per month for two months by the Licensed Vocational Nurse (LVN), (0-1) visit per month for two months for the as needed visits by the LVN, and two hours by the Registered Nurse (RN) visit for the recertification. During a review of Patient 7’s “POC,” for the certification period of 12/15/2024 to 2/12/2025, the “POC” indicated the following: “SN Medication Management Goals – Long Term Goals. Patient will verbalize/demonstrate knowledge of and compliance with medication management: Dose, route, and schedule/actions, interactions, and contraindication/administration and compliance with prefilled medications/adherence to diet impacting medications/safe preparation and storage of medications/side effects and symptoms to report within certification period.” During a review of Patient 7’s “LVN Hour,” dated 12/16/2024, 1/6/2025, 1/13/2025, and 1/27/2025, the “LVN Hour” indicated, Licensed Vocational Nurse 1 (LVN 1) did not performed medication management for Patient 7 on those respective dates. During a concurrent observation and interview on 2/12/2025 at 11:48 AM, with the Director of Patient Care Services Designee (DPCSD) and Patient 7, in Patient 7’s studio apartment, a home visit was conducted. Patient 7 refused the medication management to be performed by the DPCSD and stated, “It is a lot of medications to check.” During an interview on 2/12/2025 at 2:38 PM, with Patient 7 stated, he always refused medication management from the nurses, and the nurses never looked at his medications. During an interview on 2/13/2025 at 3:35 PM, with LVN 1 stated, Patient 7’s physician was not informed of Patient 7’s continuous refusal of the medication management, and she did not document the refusal in Patient 7’s medical record. LVN 1 further stated, the potential outcome for not documenting Patient 7’s refusal of medication management included Patient 7’s needs not being met. During an interview on 2/14/2025 at 11:17 AM, with the DPCSD stated, he recognized that the nursing staff have deficiencies in their documentation skills. The DPCSD further stated, the potential outcome of staff not documenting when patients refuse the checking of medications in the patient medical record, and not reporting these events to the physician, include too many risks for medication errors and the patients may also miss medication doses, which may cause harm. During a review of the HHA’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” revised 4/2019, the P&P indicated, “Each staff member is responsible for documenting communication with patients, families, or other staff members or contractors who are providing care to the patients. The methods of communication may be done electronically, written notes, or personal contact.” During further review of the HHA’s P&P titled, “Coordination of Care and CM Notification,” revised 4/2019, the P&P further indicated, “The Physician’s Plan of Care (485) … are available to each staff member providing care to a patient. The Agency will mail the physician’s Plan of Care (485) and other requested Care Plan to those individuals/organizations providing contracted services and patient as required by Licensing/Governing Agency.””

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the responsible physician was notified regarding patient noncompliance with their plans of care for two of seven sampled patients (Patient 6 & 7) by failing to: 1) Notify the physician promptly regarding Patient 6’s noncompliance with blood sugar (BS) checks and insulin (insulin is a hormone produced by the pancreas that plays a crucial role in regulating blood sugar levels) administration as indicated in the POC. 2) Notify the physician regarding Patient 7’s noncompliance and/or refusals with their respective medication management (refers to the comprehensive process of overseeing and coordinating all aspects of a patient’s medication regimen, which includes reviewing medications, identifying potential interactions, ensuring correct dosage, monitoring for side effects, educating patients, promoting adherence, and adjusting treatment), as per their plan of care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver). These failures had the collective potential to result in Patient 6’s and Patient 7’s medical conditions to worsen, due to a lack of informed medical supervision, a lack of comprehensive intervention, and an increased risk of medical complications due to unattended patient noncompliance. 1) During a review of Patient 6’s “Client Profile,” dated 2/11/2025, the “Client Profile” indicated, Patient 6 was admitted to the HHA on 05/01/2018. During a review of Patient 6’s “RN Recert,” dated 1/22/25, the “RN Recert” indicated, Patient 6 had a primary diagnosis of Type 1 diabetes mellitus (DM Type I – an autoimmune disorder that destroys insulin-producing tissues in the body, leading to an insulin insufficiency that can cause excess blood sugar) with diabetic neuropathy (nerve damage caused by uncontrolled high blood sugar from DM), as well as essential (primary) hypertension (HTN – also known as high blood pressure, a chronic disease that includes excess pressure within the blood vessels), depression (a mental health condition), and left-side below the knee amputation. During a review of Patient 6’s “RN Recert,” dated 07/25/24, the “RN Recert” indicated, Patient 6 checked her own BS level, but Patient 6’s DexcomG7 (a blood sugar monitoring device that attaches to the patient, so the patient can more accurately monitor their blood sugar measurements) was not attached to her at the time of the assessment. Patient 6’s noncompliance with her BS checks was not reported to the physician. During a review of Patient 6’s “LVN Hour,” dated 1/27/25, the “LVN Hour” indicated, “Patient 6 refused for her vital signs (V/S) to be taken… Patient is noted being noncompliant blood sugar checks.” No intervention nor notification to the physician regarding Patient 6’s noncompliance with BS checks was documented within Patient 6’s clinical record. During a review of Patient 6’s “LVN Hour,” dated 2/10/25, the “LVN Hour” indicated, Patient 6 was noncompliant with her blood sugar checks and administration of insulin. Patient 6 was documented as stating, “I don’t feel like checking it.” No intervention nor notification to the physician regarding Patient 6’s noncompliance with BS checks and insulin self-administration was documented within Patient 6’s clinical record. During a concurrent observation and interview on 2/12/25 at 3 p.m., with the Director of Patient Care Services Designee (DPCSD) and Patient 6, in Patient 6’s apartment during a home visit, Patient 6 verbalized that she used a DexcomG7 for BS monitoring and administered her insulin via an Omnipod 5, but neither device was in her possession. During a review of Patient 6’s “RN Supervisory Visit,” dated 2/12/25, the “RN Supervisory Visit” indicated, no coordination with the physician regarding Patient 6’s noncompliance with BS checks and insulin administration was documented. During an interview with the DPCSD on 2/14/25 at 11:30 a.m., the DPCSD stated, “If a patient is refusing care, like vital signs, blood sugar checks, administration of medications, wound assessment, documentation is necessary about the refusal, risks and benefits about knowing the decline of the service. They are encouraged to call the staff if they change their mind about the refusal, like site managers, or tech, any phone call to [Name of Public Subsidized Housing Program Manager (PSH Program Manager)]. Inform the caregiving staff. Report to CCA (Clinical Care Agency), it depends on the client, they can choose their own agency. Refusal of care should be coordinated with RN, CCA and should be called to MD (physician).” During a review of the facility’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” dated April 2019, the P&P indicated, “Each staff members is responsible for documenting communication with patients, families, or other staff members/contractors providing care. Methods for communicating may be via telecommunications, electronically, written notes or personal contact. Staff will document communications in a Visit Note, Communication Note, Inter-office communication note (electronically, Physician’s Order form, or Summary of Care form.” 2) During a review of Patient 7’s “Client Profile,” 10/15/2024, the “Client Profile” indicated, Patient 7 was admitted to the HHA on 10/16/2024, with a primary diagnosis of Type 2 diabetes mellitus (a chronic disease that occurs when the body does not produce or use insulin properly, resulting in high blood sugar levels) with diabetic nephropathy (a complication of diabetes mellitus that damages the kidneys). During a review of Patient 7’s “Home Health Certification and Plan of Care,” for the certification period of 12/15/2024 to 2/12/2025, the “POC” indicated the following: Skilled Nursing (SN - refers to licensed nurses, in general) visit frequency (0-4) hours per month for two months by the Licensed Vocational Nurse (LVN), (0-1) visit per month for two months for the as needed visits by the LVN, and two hours by the Registered Nurse (RN) visit for the recertification. During a review of Patient 7’s “Home Health Certification and Plan of Care,” for the certification period of 12/15/2024 to 2/12/2025, the “POC” indicated the following: SN Medication Management Goals – Long Term Goals (LTG – the outcomes a patient is expected to achieve over time). Patient will verbalize/demonstrate knowledge of and compliance with medication management: Dose, route, and schedule/actions, interactions, and contraindication/administration and compliance with prefilled medications/adherence to diet impacting medications/safe preparation and storage of medications/side effects and symptoms to report within certification period. During a review of Patient 7’s “LVN Hour,” dated 12/16/2024, 1/6/2025, 1/13/2025, and 1/27/2025, the “LVN Hour” indicated, Licensed Vocational Nurse 1 (LVN 1) performed medication management for Patient 7. During a concurrent observation and interview on 2/12/2025 at 11:48 AM, with the Director of Patient Care Services Designee (DPCSD) and Patient 7, in Patient 7’s studio apartment, a home visit was conducted. Patient 7 refused for the medication management to be performed by the DPCSD and stated, “It is a lot of medications to check.” During an interview on 2/12/2025 at 2:38 PM, with Patient 7 stated, he always refused medication management from the nurses, and the nurses never looked at his medications. During an interview on 2/13/2025 at 3:35 PM with LVN 1 stated, Patient 7’s physician was not informed of the continual refusals of the medication management, and she did not document the refusals in Patient 7’s medical record. During an interview on 2/14/2025 at 11:17 AM with the DPCSD stated, he recognized that the nursing staff have deficiencies in their documentation skills. The DPCSD further stated, the potential outcome of staff not documenting when patients refuse the checking of medications in the patient medical record and not reporting to the physician include too many risks for medication errors, and the patients may also miss medication doses, which may cause harm. During a review of the HHA’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” revised 4/2019, the P&P indicated, “each staff member is responsible for documenting communication with patients, families, or other staff members or contractors who are providing care to the patients. The methods of communication may be done electronically, written notes, or personal contact.””

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to revise the plan of care (a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) to reflect clinical information identifying the patient’s progress toward the measurable outcomes and goals for one of seven sampled patients (Patient 3). This deficient practice had the potential to affect the HHA’s ability to meet the patient’s identified needs. During a review of Patient 3’s Home Health Certification and Plan of Care for the certification period of 2/7/2025 to 4/7/2025, the Home Health Certification and Plan of Care indicated that Patient 3 was admitted to the HHA on 5/25/2016 with a principal diagnosis of type 2 diabetes mellitus (a chronic [persisting for a long time or constantly recurring] condition that happens when the blood glucose [a type of sugar] is too high; it develops when the a person’s body is not responding to the effects of insulin (a hormone made in the pancreas [a gland located behind the stomach] that allows the body to use glucose for energy) with diabetic neuropathy (a complication of diabetes that damages the nerves in the body). During a review of the Treatments and Orders for Disciplines section of Patient 3’s Home Health Certification and Plan of Care, for the certification period of 2/7/2025 to 4/7/2025, indicated the frequency for Skilled Nurse (SN-licensed nurse) visit was between 0 to 8 hours per month for two months with two as needed SN visits. There were no treatment and orders for the discipline to perform, rehabilitation potential, goals, or discharge plans. The Clinician’s Signature section of the Home Health Certification and Plan of Care was dated 2/5/2025, with no signature on it. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 2/14/2025 at 4:10 p.m., the DPCS reviewed the Home Health Certification and Plan of Care for the certification period of 2/7/2025 to 4/7/2025 for Patient 3. The DPCS confirmed there were no treatments and orders for disciplines for the current certification period. The DPCS also confirmed there were no rehabilitation potential, discharge plans, or goals for Patient 3. The DPCS stated the Treatments and Orders for Disciplines section was supposed to have the nursing interventions for the patient, the Rehabilitation Potential/Discharge Plans/Goals was supposed to list the goals of each nursing intervention for Patient 3. The DPCS stated that the Home Health Certification and Plan of Care for the certification period of 2/7/2025 to 4/7/2025 for Patient 3 was incomplete. DPCS stated the plan of care provided guidance to the home health staff in providing care to the patient and to evaluate the patient’s progress toward the goals. The DPCS stated an incomplete plan of care could affect necessary interventions and patient outcomes. During a review of the HHA’s policy and procedure, titled “Plan of Care,” revised January 2022, the policy and procedure indicated that the care plan should include: - Prognosis - Rehabilitation potential - Statement of treatment goals - Discharge and referral plan”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview the Home Health Agency (HHA) failed to ensure the patients’ clinical records contained completed comprehensive assessment, plan of care, and clinical notes identifying documented evidence of blood sugar monitoring and wound care management for two of 7 sampled patients (Patients 3 and 6). This deficient practice resulted to an incomplete clinical records leading to misinformation and non-continuity of care and services to be provided to these patients certified to receive the Medicare home health benefits. During a review of Patient 6’s “RN Recert,” dated 1/22/25, the “RN Recert” indicated, Patient 6 had a primary diagnosis of Type 1 diabetes mellitus (DM Type I – an autoimmune disorder that destroys insulin-producing tissues in the body, leading to an insulin insufficiency that can cause excess blood sugar) with diabetic neuropathy (nerve damage caused by uncontrolled high blood sugar from DM), as well as essential (primary) hypertension (HTN – also known as high blood pressure, a chronic disease that includes excess pressure within the blood vessels), depression (a mental health condition), and left-side below the knee amputation. “Patient “Client Profile,” dated 2/11/2025, indicated Patient 6 was admitted to the HHA on 05/01/2018. During a review of Patient 6’s “RN Recert,” dated 7/25/2024, indicated, Patient 6 had “wound to their right lower leg, and the wound from the past three months, has increased redness surrounding the 2-dime size open wounds with small amount of clear drainage. Patient does not dress the wound. Patient was noncompliant with her hygiene and keeping the area clean.” No documentation was noted in Patient 6’s comprehensive assessment regarding Patient 6’s wound measurement, wound treatment, nor who was responsible for performing Patient 6’s wound care. There was no updated comprehensive assessment whether the wound responded to the treatment and had healed or declined. During a review of Patient 6’s “RN Supervisory Visit,” dated 8/29/24, indicated Patient 6’s wound had worsened, having turned red and purple in color surrounding the two dime-sized open wounds from a month prior. No documentation was noted in Patient 6’s comprehensive assessment regarding Patient 6’s wound measurement, wound treatment, nor who was responsible for performing Patient 6’s wound care. There was no coordinated documentation towards Patient 6’s comprehensive assessment was available from the Director of Patient Care Services Designee (DPCSD), the Director of Patient Care Services (DPCS), the Clinical Care Agency (CCA), and the responsible physician. During an interview on 2/14/25 at 11:30 a.m., with the Director of Nursing (DON), the DON stated, “Documentation on wound assessment is necessary. Nurses are not doing any wound measurement. Nurses are supposed to use ruler to measure wound, taking a picture. Nurses not assessing wound like they’re supposed to.” During a review of the facility’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” dated April 2019, the P&P indicated, “The clinician will make an initial assessment of any wound during the first physical assessment using the OASIS, Non-OASIS Evaluation form or Pediatric Assessment/Evaluation to establish a baseline. The clinician will determine the type of open wound(s), i.e. pressure injury, stasis wound, surgical wound, abrasion, and burns etc. The assessment will include the observation and measurement of wound(s) appearance, size, undermining and characteristic of wound, odor and discharge. The clinician will develop plan of treatment and wound care with the referring physician approval. The plan of care will include the orders stating the treatment of wound(s), frequency and pattern of dressing change, supplies of choice, and level of and caregiver involvement. The clinician will document all information regarding wound observation(s) and treatment(s) in the patient record. The SN (skilled nurse) may continue with the wound care on subsequent visits. The wound will be re-assessed and measured at least weekly or as often as needed and documented on the wound progress note and/or skilled note Wound is measure as follows: Length – wound bed is measured head to toe orientation; Width – wound bed is measured with lateral orientation; Specific or identifiable aspects of the wound shall be referred using the “clock” orientation. The attending physician must be notified of any changes of wound conditions, i.e. decrease or increase of size, depth, odor, and discharge. The clinician is responsible to obtain the new order(s) from the attending, if warranted.” 2. During a review of Patient 3’s clinical record it indicated the patient was admitted to the home health agency (HA) on 5/25/2016 with a primary diagnosis of Type 2 diabetes (type of diabetes mellitus with high blood sugar and insulin resistance). During a review of the Plan of Care (POC) with a certification period of 12/9/2024 to 2/6/2025 it indicated skilled nurse visits of 0-8 hours per month for 2 months, SN 0-1 visits per month for 2 months, PRN visits /hours 2 (as needed). The POC further indicated endocrine interventions to be performed by the nursing staff to include assessment and instruction on the following areas: diabetic diet and exercise, skin and diabetic foot care, insulin administration and the importance of compliance. During a review of Patient 3’s nursing notes with the following dates 12/16/2024, 12/23/2024, and 1/13/2025 indicated no entries of the blood sugar levels were documented in the patient’s clinical record. During an interview conducted on 2/13/2025 at 4 pm, with LVN 1 stated, she was familiar with Patient 3’s care plan, and further stated she does not check or assess her blood sugar levels each visit. LVN 1 stated she would only ask if Patient 3 took her blood sugar and noted the response. During a review of the agency’s policy entitled “Plan of Care” with a revised date of January 2022 it indicated the purpose of the policy was to establish a uniform format for the content and the documentation of physician’s orders for each patient. It is the policy of this agency to implement an individualized Plan of Care or Plan of Treatment created and developed with the patient and/or legal representative, primary care physician, clinicians and service providers. The care plan shall include: diabetic screening, Hgb A1C, once every 3 months as per MD recommendation.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure that all interventions, including medication administration, treatments, services, and patient responses to those interventions were documented for two of seven sampled patients (Patient 3, and Patient 7). This deficient practice had the potential to result for these certified patients will not be provided the care and services identified in the plan of care that could affect their health status and wellbeing. During a review of Patient 3’s Home Health Certification and Plan of Care for the certification period of 2/7/2025 to 4/7/2025, the Home Health Certification and Plan of Care indicated that Patient 3 was admitted to the HHA on 5/25/2016 with a principal diagnosis of type 2 diabetes mellitus (a chronic [persisting for a long time or constantly recurring] condition that happens when the blood glucose [a type of sugar] is too high; it develops when the a person’s body is not responding to the effects of insulin (a hormone made in the pancreas [a gland located behind the stomach] that allows the body to use glucose for energy) with diabetic neuropathy (a complication of diabetes that damages the nerves in the body). During a review of the Treatments and Orders for Disciplines section of Patient 3’s Home Health Certification and Plan of Care, for the certification period of 2/7/2025 to 4/7/2025, the document indicated the frequency for Skilled Nurse (licensed nurse) visit was between 0 to 8 hours per month for two months with two as needed SN visits. The Treatments and Orders for Disciplines did not indicate the treatments and orders for disciplines for Patient 3. The Rehabilitation Potential/Discharge Plans/Goals did not indicate the rehabilitation potential, discharge plans, or goals for Patient 3. The Clinician’s Signature section of the above Home Health Certification and Plan of Care was dated 2/5/2025, with no signature on it. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 2/14/2025 at 4:10 p.m., the DPCS reviewed the Home Health Certification and Plan of Care for the certification period of 2/7/2025 to 4/7/2025 for Patient 3. The DPCS confirmed there were no treatments and orders for disciplines for Patient 3 for the current certification period. The DPCS also confirmed there were no rehabilitation potential, discharge plans, or goals for Patient 3. The DPCS stated the Treatments and Orders for Disciplines section was supposed to have the nursing interventions for the patient, the Rehabilitation Potential/Discharge Plans/Goals was supposed to list the goals of each nursing intervention for Patient 3. The DPCS stated that the Home Health Certification and Plan of Care for the certification period of 2/7/2025 to 4/7/2025 for Patient 3 was incomplete. Per DPCS, the care plan was derived from the recertification that was done on 2/5/2025. Per DPCS, the nurse who completed the recertification assessment fell sick, and other staff did not feel comfortable completing the plan of care. When the DPCS was asked what the negative outcome of an incomplete plan of care, the DPCS stated the plan of care provided guidance to the home health staff in providing care to the patient and to evaluate the patient’s progress toward the goals. The DPCS stated an incomplete plan of care could affect necessary interventions and patient outcomes. During a review of the HHA’s policy and procedure, titled “Clinical Record,” revised March 2021, the policy and procedure indicated that OASIS, F-CAP, assessment tool etc. assessments and/or evaluations, care plans are to be submitted to the agency within 48-72 hours from the visit date. 1) During a review of Patient 7’s “Client Profile,” 10/15/2024, the “Client Profile” indicated, Patient 7 was admitted to the HHA on 10/16/2024, with a primary diagnosis of Type 2 diabetes mellitus (a chronic disease that occurs when the body does not produce or use insulin properly, resulting in high blood sugar levels) with diabetic nephropathy (a complication of diabetes mellitus that damages the kidneys). During a review of Patient 7’s “Home Health Certification and Plan of Care,” for the certification period of 12/15/2024 to 2/12/2025, the “POC” indicated the following: Skilled Nursing (SN - refers to licensed nurses, in general) visit frequency 0-4 hours per month for two months by the Licensed Vocational Nurse (LVN), 0-1 visit per month for two months for the as needed visits by the LVN, and two hours by the Registered Nurse (RN) visit for the recertification. During a review of Patient 7’s “Home Health Certification and Plan of Care,” for the certification period of 12/15/2024 to 2/12/2025, the “POC” indicated the following: SN Medication Management Goals – Long Term Goals (LTG – the outcomes a patient is expected to achieve over time). Patient will verbalize/demonstrate knowledge of and compliance with medication management: Dose, route, and schedule/actions, interactions, and contraindication/administration and compliance with prefilled medications/adherence to diet impacting medications/safe preparation and storage of medications/side effects and symptoms to report within certification period. During a review of Patient 7’s “LVN Hour,” dated 12/16/2024, 1/6/2025, 1/13/2025, and 1/27/2025, the “LVN Hour” indicated, LVN 1 performed medication management for Patient 7. During a concurrent observation and interview on 2/12/2025 at 11:48 AM with the Director of Patient Care Services Designee (DPCSD) and Patient 7, in Patient 7’s studio apartment, a home visit was conducted. Patient 7 refused for the medication management to be performed by the DPCSD and stated, “It is a lot of medications to check.” During an interview on 2/12/2025 at 2:38 PM with Patient 7, Patient 7 stated, he always refused medication management from the nurses, and the nurses never looked at his medications. During an interview on 2/13/2025 at 3:35 PM with Licensed Vocational Nurse 1 (LVN 1), LVN 1 stated, Patient 7’s physician was not informed of the continual refusals of the medication management, and she did not document the refusals in Patient 7’s medical record. During an interview on 2/14/2025 at 11:17 AM with the DPCSD, the DPCSD stated, he recognized that the nursing staff have deficiencies in their documentation skills. The DPCSD further stated, the potential outcome of staff not documenting when patients refuse the checking of medications in the patient medical record and not reporting to the physician include too many risks for medication errors, and the patients may also miss medication doses, which may cause harm. During a review of the HHA’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” revised 4/2019, the P&P indicated, “each staff member is responsible for documenting communication with patients, families, or other staff members or contractors who are providing care to the patients. The methods of communication may be done electronically, written notes, or personal contact.” 2) During a review of Patient 6’s “Client Profile,” dated 2/11/2025, the “Client Profile” indicated, Patient 6 was admitted to the HHA on 05/01/2018. During a review of Patient 6’s “RN Recert,” dated 1/22/25, the “RN Recert” indicated, Patient 6 had a primary diagnosis of Type 1 diabetes mellitus (DM Type I – an autoimmune disorder that destroys insulin-producing tissues in the body, leading to an insulin insufficiency that can cause excess blood sugar) with diabetic neuropathy (nerve damage caused by uncontrolled high blood sugar from DM), as well as essential (primary) hypertension (HTN – also known as high blood pressure, a chronic disease that includes excess pressure within the blood vessels), depression (a mental health condition), and left-side below the knee amputation. During a review of Patient 6’s “RN Recert,” dated 7/25/2024, the “RN Recert” indicated the following for Patient 6: “she monitors her BS (blood sugar) with DExcomG7 and changes every 10 days, however patient did not have it on during the visit, stating she, will put it on later. RN offered to install it, however patient declined the help. Patient uses Omnipod 5 (A wearable tubeless insulin delivery system that automatically adjusts insulin based on glucose levels) for insulin administration. Wound (has wound to the right lower leg) from the past 3 months has increased redness surrounding the 2-dime size open wounds with small amount of clear drainage. Patient does not dress the wound. Patient is noncompliant with her hygiene and keeping the area clean.” During further review of Patient 6’s “RN Recert,” dated 7/25/2024, the “RN Recert” further indicated, Patient 6’s wounds did not have wound measurements nor wound treatments, and the individuals responsible for performing Patient 6’s wound care were not indicated. Interventions for Patient 6’s noncompliance with blood sugar checks and insulin self-administration were not documented in Patient 6’s clinical record. During a review of Patient 6’s “RN Supervisory Visit,” dated 8/29/24, the “RN Supervisory Visit” indicated, Patient 6 “has 1+ pitting edema (pitting edema occurs when swelling is caused by a buildup of fluids, usually in the lower body) to RLE (right lower extremity). Patient refused to give any information regarding BS reading. Patient states, she monitors her BS with DexcomG7 and changes every 10 days, however patient did not have it on during the, stating she will have it on later. RN offered to install it, however patient declined the help. Patient uses Omnipod 5 for insulin administration. Also, did not have it on and refused for any help. Wound has increased redness/purple surrounding the 2-dime size open wounds. Patient is not compliant with hygiene. However, patient did not reach out to MD with wound concerns states she was on antibiotics a month ago. However, wound appears worse than a month ago. Patient is not compliant in keeping area clean.” During a further review of Patient 6’s “RN Supervisory Visit,” dated 8/29/24, the “RN Supervisory Visit” further indicated, Patient 6’s wounds did not have wound measurements nor wound treatments, and the individuals responsible for performing Patient 6’s wound care were not indicated. The documented coordination with the physician did not include the physician’s name nor what was communicated. During an interview on 2/14/25 at 11:30 a.m. with the DPCSD, the DPCSD stated, “If a patient is refusing care, like vital signs, blood sugar checks, administration of medications, wound assessment, documentation is necessary about the refusal, risks and benefits about knowing the decline of the service.” During a review of the facility’s policy and procedure (P&P) titled, “Coordination of Care and CM Notification,” dated April 2019, the P&P indicated, “Staff members providing care to the patients will coordinate care with other organizations, agencies, and/or individuals specific to each Department’s Licensing Agency regulations and requirements. All conversations, referrals, and cooperative plans are to be documented in the patient’s clinical records.””