Unique Home Health Services Inc.

“Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. 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 follow the provision of standard for state and federal policy for the qualification, training and requirements of an Administrator. This deficient practice had the potential for the Administrator to ineffectively manage the responsibility for the day-to-day operation of the HHA. A review of the HHA’s “Administrator Employee Files” on 12/18/2023 indicated that the agency’s current Administrator did not have the training or certification in health service administration. On concurrent review of the Administrator resume on file indicated that her experience detailed being a homemaker 3/2006 to 10/2016, a mortgage loan officer form 11/2016 to present and owner/Vice President of an agency, WLA from 6/2019 up to present. During an interview with the Administrator on 12/18/2023 at 11:45 a.m., the Administrator stated that she did not have administrator certification or training. The Administrator stated that to her knowledge, she did not need an administrator certification or training to run agency. A review of the HHA’s policy titled “Administrator: Job Description” revised 3/2022, indicated General Purpose: Responsible for all aspects of the agency’s operations which includes sales, market development and the financial status in accordance with the law and regulation, and appropriate standards of practice. Accountable for the direction of their agency’s staff and overall operation of the designated agency. Implements directives of the governing body. Minimum Education & Experience Requirements: Has training and experience in health service administration. Is a physician, registered nurse, or hold an undergraduate degree. One (1) year of supervisory or administrative experience in home health care or related health programs. Six (6) years of progressive advancement in business. Four (4) years of management experience that includes planning, staff supervision and P&L responsibility.”

“Continuing need for home care CFR(s): 484.55(c)(3) The patient’s continuing need for home care; This Element 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 assess the patient’s continuing need for skilled nursing services for two of 9 sampled patients (Patients 2 and 5). This deficient practice resulted in the provision of an unnecessary home health services to the patients who did not need skilled nursing services. a. A review of Patient 2’s Personal Information sheet indicated a start of care date (SOC) of 2/22/2022, with diagnosis that included type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]). A review of Patient 2’s Home Health Certification and Plan of Care (POC) for the certification period starting from 9/4/2023 to 11/2/2023, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. The goal included patient’s blood sugar will be maintained within the range 60-250 milligrams per deciliter (mg/dl), patient will have no skin breakdown, blood pressure levels maintained within normal parameters, no signs and symptoms of shortness of breath and respiratory distress, and patient will remain safe at home without incidents of fall, injury or hospitalization throughout the certification period. Discharge planning indicated to discharge when medical condition is stable, and when patient is no longer in need of skilled services. A review of Patient 2’s Skilled Nurse Visit Notes from 9/4/23 to 10/28/2023 indicated Patient 2’s blood sugar ranging from 115 to 137, blood pressure ranging from 132-145 systolic (first number) and 65-88 diastolic (second number). The rest of the patient’s vital signs (temperature, pulse rate and respiratory rate) were within a normal range. There were no admissions to the hospital, no pain, no episodes of falls, no wound care performed, and any evidence of the need for skilled nursing services to continue. The patient was re-certified for another 60 days for continuous skilled nursing services. During an interview on 12/16/2023, at 2 p.m., with family member (FM 1), FM 1 stated Patient 2’s blood sugar and blood pressure readings had been well-controlled for the most part with medications. FM 1 stated, Patient 2 could walk around the house independently, have no recent hospitalization, no falls, and no wound care. b. A review of Patient 5’s Personal Information sheet indicated a start of care date (SOC) of 4/20/2021, with diagnosis that included lupus (an inflammatory disease caused when the immune system attacks it’s own tissue). A review of Patient 5’s Home Health Certification and Plan of Care (POC) for the certification period starting from 8/8/2023 to 10/6/2023, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. The goal included patient’s blood sugar will be maintained within the range 60-250 milligrams per deciliter (mg/dl, unit of measurement), patient will have no skin breakdown, blood pressure levels maintained within normal parameters, no signs and symptoms of shortness of breath and respiratory distress, and patient will remain safe at home without incidents of fall, injury or hospitalization throughout the certification period. Discharge planning indicated to discharge when medical condition is stable, and when patient is no longer in need of skilled services. A review of Patient 5’s Skilled Nurse Visit Notes from 8/8/2023 to 10/2/2023 indicated Patient 5’s blood sugar ranging from 115 to 137, blood pressure ranging from 132-145 systolic (first number) and 65-88 diastolic (second number). The rest of the patient’s vital signs (temperature, pulse rate and respiratory rate) were within a normal range. There were no admissions to the hospital, no pain, no episodes of falls, no wound care performed, and any evidence of the need for skilled nursing services to continue. The patient was re-certified for another 60 days for continuous skilled nursing services. During an interview on 12/17/2023, at 1 p.m., with the Director of Patient Care Services Designee (DPCS Designee), the DPCS Designee stated, Patient 2 and Patient 5’s vital signs and blood sugar readings has been stable, no change in condition of the patient, no falls, no hospitalization, no wound care done, patient goals has been met and should have been discharged. A review of the agency’s undated policy and procedure titled, “Client Discharge Process”, indicated discharge planning is initiated for every home care client at the time of the client’s admission for home care. The Client shall be discharged from home health services on the basis of reasonable criteria which includes the client has reached defined goals and is no longer in need of home care. A review of the agency’s undated policy and procedure titled, “Discharge Criteria and Process”, indicated the purpose of the policy is to outline the process for discharging a patient from service. Services will be terminated when the patient meets one of the following discharge criteria: if appropriate, the physician (or other authorized licensed independent practitioner) and the organization agree that the goals of home health have been attained or are no longer attainable.”

“Continuing need for home care CFR(s): 484.55(c)(3) The patient’s continuing need for home care; This Element 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 assess the patient’s continuing need for skilled nursing services for two of 9 sampled patients (Patients 2 and 5). This deficient practice resulted in the provision of an unnecessary home health services to the patients who did not need skilled nursing services. a. During a review of Patient 2’s clinical record indicated a start of care date (SOC) of 2/22/2022, with diagnosis that included type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]). During a review of Patient 2’s Home Health Certification and Plan of Care (POC) for the certification period starting from 9/4/2023 to 11/2/2023, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. The goal included patient’s blood sugar will be maintained within the range 60-250 milligrams per deciliter (mg/dl), patient will have no skin breakdown, blood pressure levels maintained within normal parameters, no signs and symptoms of shortness of breath and respiratory distress, and patient will remain safe at home without incidents of fall, injury or hospitalization throughout the certification period. Discharge planning indicated to discharge when medical condition is stable, and when patient is no longer in need of skilled services. During a review of Patient 2’s Skilled Nurse Visit Notes from 9/4/23 to 10/28/23 indicated Patient 2’s blood sugar ranging from 115 to 137, blood pressure ranging from 132-145 systolic (first number) and 65-88 diastolic (second number). The rest of the patient’s vital signs (temperature, pulse rate and respiratory rate) were within a normal range. There were no admissions to the hospital, no pain, no episodes of falls, no wound care performed, and any evidence of the need for skilled nursing services to continue. The patient was re-certified for another 60 days for continuous skilled nursing services. During an interview on 12/16/2023, at 2 p.m., with family member (FM 1), FM 1 stated Patient 2’s blood sugar and blood pressure readings had been well-controlled for the most part with medications. FM 1 stated, Patient 2 could walk around the house independently, had no recent hospitalization, no falls, and no wound care. b. During a review of Patient 5’s clinical record indicated a start of care date (SOC) of 4/20/2021, with diagnosis that included lupus (an inflammatory disease caused when the immune system attacks its own tissue). During a review of Patient 5’s Home Health Certification and Plan of Care (POC) for the certification period starting from 8/8/2023 to 10/6/2023, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. The goal included patient’s blood sugar will be maintained within the range 60-250 milligrams per deciliter (mg/dl, unit of measurement), patient will have no skin breakdown, blood pressure levels maintained within normal parameters, no signs and symptoms of shortness of breath and respiratory distress, and patient will remain safe at home without incidents of fall, injury or hospitalization throughout the certification period. Discharge planning indicated to discharge when medical condition is stable, and when patient is no longer in need of skilled services. During a review of Patient 5’s Skilled Nurse Visit Notes from 8/8/23 to 10/2/23 indicated Patient 5’s blood sugar ranging from 115 to 137, blood pressure ranging from 132-145 systolic (first number) and 65-88 diastolic (second number). The rest of the patient’s vital signs (temperature, pulse rate and respiratory rate) were within a normal range. There were no admissions to the hospital, no pain, no episodes of falls, no wound care performed, and any evidence of the need for skilled nursing services to continue. The patient was re-certified for another 60 days for continuous skilled nursing services. During an interview on 12/17/2023, at 1 p.m., with the Director of Patient Care Services Designee (DPCS Designee), the DPCS Designee stated, Patient 2 and Patient 5’s vital signs and blood sugar readings has been stable, no change in condition of the patient, no falls, no hospitalization, no wound care done, patient goals have been met and Patient 2 and Patient 5 should have been discharged from HHA services. During a review of the agency’s undated policy and procedure titled, “Client Discharge Process”, indicated discharge planning is initiated for every home care client at the time of the client’s admission for home care. The Client shall be discharged from home health services on the basis of reasonable criteria which includes the client has reached defined goals and is no longer in need of home care. During a review of the agency’s undated policy and procedure titled, “Discharge Criteria and Process”, indicated the purpose of the policy is to outline the process for discharging a patient from service. Services will be terminated when the patient meets one of the following discharge criteria: if appropriate, the physician (or other authorized licensed independent practitioner) and the organization agree that the goals of home health have been attained or are no longer attainable.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to maintain an accurate, and current medication profiles for 2 of 9 sampled patients (Patients 6 and 7). This deficient practice had the potential to result in placing the patient at risk for medication errors, adverse drug reactions, duplicate and ineffective medications. 1. A review of Patient 6’s Patient Profile Information indicated, a start of care (SOC) date of 7/24/2023, with a certification period reviewed of 11/21/2023 to 1/19/2023, with diagnosis included hypothyroidism (happens when the thyroid gland doesn’t make enough thyroid hormone (a body hormone that helps regulate body temperature, heart rate and metabolism) and Alzheimer’s disease (a type of dementia that affects memory, thinking and behavior that can affect activities of daily life). Skilled nursing visit for once a week for one week and as needed for resumption/recertification or discharge. Physical Therapy for evaluation and treatment. A review of Patient 6’s” Home Health Certification and Plan of Care” for the period of 11/21/2023 to 1/19/2023 clinical justification for need of continued home health services for Patient 6 indicated, the patient/caregiver need reinforce teaching on areas of knowledge deficit. Continued physical therapy and skilled intervention needed to decrease risk & further complications through early intervention if changes occur and detailed instruction regarding: medications, disease process, proper care and management of patient with complex medical history. SN to instruct Patient/caregiver to protect patient’s feet from extreme heat or cold. Skilled Nursing (SN) to assess pain level and effectiveness of pain medications and current pain management therapy every visit. SN to instruct patient on nonpharmacologic pain relief measures, including relaxation techniques. SN to report to physician if patient experiences pain level not acceptable to patient, pain level greater than 6/10, pain medications not effective, patient unable to tolerate pain meds, pain affecting ability to perform patient’s normal activities. SN to instruct the Patient/caregiver on medication regimen dose, indications, side effects, and interactions. A home visit was conducted on 12/16/2023 at 3:00 p.m., with Licensed Vocational Nurse 1(LVN 1). Patient 1 was observed to walking using a walker , forgetful, unable to finish and complete sentences, alert to name, not in any respiratory distress. Patients daughter was present during the home visit. During a review of Patient 6’s medications currently taking reconciling with the medication profile on 12/16/2023, at 3:30 p.m., indicated the following medications were not updated in the medication profile: Vitamin B-12 1000 micrograms (mcg- a unit of measurement) 1 tablet daily as supplement Vitamin D 1000 IU (international units- a unit of measurement) 1 tablet daily for supplement Nebivolol 5 milligrams (mg-unit of measurement) 1 tablet daily for blood pressure were not listed in the medication list. 2. A review of Patient 7’s Patient Profile Information indicated the SOC for patient was 5/11/2018 with the certification period reviewed for 12/1/2023 to 2/08/2023. Patient 7’s diagnosis is Type 2 diabetes ( a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel) with hyperglycemia (elevated blood sugar levels) and Parkinson’s disease ( a progressive disorder that affects the nervous system and the parts of the body controlled by the nerves). A review of the document titled “Home Health Certification and Plan Of Care” for the certification period of 12/11/2023 to 2/8/2023 indicated that Clinical justification for need of continued home health services for Patient 7 includes patient needs daily insulin injections twice daily, caregiver unwilling to provide daily injections indicates it is too complex, unable to locate alternative caregiver for insulin administration after several attempts. The patient is extremely forgetful, has visual problems, and poor dexterity of hands due to Parkinson’s Disease, hand tremors and is unable to self-administer insulin. Trial run of self-administration of insulin was not successful as patient was not administering insulin consistently or with the correct technique. SN to instruct Patient/caregiver on all aspects of diabetic management to include disease process, foot assessments, signs and symptoms of hypo/hyperglycemia, glucometer use and preparation and administration of diabetic medications ordered by physician. SN to assess blood sugar via finger stick every visit prior to insulin administration. SN to check prepare and administer: Victoza subcutaneous 18 MG/3ML give 1.2mg subcutaneously Daily in AM and; Toujeo solostar subcutaneous 300 UNIT/ML inject 40 units subcutaneously daily in AM. SN to instruct the Patient/Caregiver on medication regimen dose, indications, side effects, and interactions. SN to assess the Patient/caregiver administering injectable medications to determine if proper technique is utilized. SN to assess blood sugar via finger stick every visit prior to insulin administration. During a home visit was conducted on 12/16/2023 at 2:44 p.m., with LVN 1. Patient 7 was observed to slowly walking using an assistive device, alert to name, person and place, not in any respiratory distress. Patients daughter was present during the home visit. During a review of Patient 7’s medications currently taking reconciling with the medication profile on 12/16/2023, at 3:00 p.m., indicated the following medications were not updated in the medication profile: Vitamin B1 100 mg daily as supplement Trazodone Hydrochloride 50 mg at bedtime for sleep Quetiapine Fumarate 25 mg at night for parkinson’s Ropirinole 25 mg at bedtime for parkinson’s Nortriptyline 10 mg daily for depression Simvastatin 10 mg daily for cholesterol Mirtazapine 30 mg daily for depression and anxiety Bystolic 5 mg daily for blood pressure were all discontinued per caregiver(daughter). Sertraline 25mg daily was a new medication prescribed by the patients doctor for parkinson’s Jardiance 25 mg 1 tablet daily for diabetes had no label indicating the dose and frequency instructions. Victoza subcutaneous (or SQ- injected under the skin) 18 MG/3ML(milliliter- unit of measurement) give 1.2mg subcutaneously daily in the morning had no date indicating when it was last opened Toujeo solostar subcutaneous 300 UNIT/ML inject 40 units subcutaneously daily in the morning had no date indicating when it was last opened. During an interview with the the daughter of Patient 7 at the same date stated that the nurse who frequently visits is in charge of the patient’s insulin. Caregiver stated she noticed the blank dates on the box of each insulin but was not educated on writing when the date the insulin pen was opened. Caregiver also confirmed that she did not know that the insulin is only viable for 28 days upon opened. During an interview with LVN 1 on 12/16/2023 at 3:30 p.m., stated that the nurse should always check medications every home visit and should write the dates when the insulin was open to know the the insulins viability. During a concurrent interview and record review with the Interim Director of Nursing (IDON) and the Administrator (Admin) on 12/18/23 at 11:45 a.m., IDON stated it is important that the nurse checks medications every home visit. A review of the HHA’s Policy titled “ Medications” dated 12/21/2021 indicated Interim HealthCare ensures that they have the right patient, right drug, right dose, right route and right time prior to administering any medication. The designated qualified nurse provides the patient/caregiver with medication instructions that include at a minimum: a) Safe and effective use of medication; b) Name and description of the medication; c) Dosage, route of administration, and duration of drug therapy; d) Special directions and precautions for preparation, self-administration as appropriate; e) Safeguards against microbial contamination; f) Intended use and expected actions of the medication; g) Significant side effects or interactions and therapeutic contraindications; h) Techniques for the self-monitoring of drug therapy, as appropriate; i) Proper storage and expiration dating of medications; j) Prescription refill information; k) Action to be taken in the event of missed dose (e.g., contact the physician or allowed practitioner.”

“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 interview, and record review, the HHA (home health agency) failed to ensure the plan of care contained the management and monitoring of the use of psychotropic medications (any drug that affects mental function, behavior, and mood) for two of 9 sampled patients (Patient 5 and 7) by failing to: - Ensure indications for the use of psychotropic medications for the identified problem. - Ensure a signed informed consent (permission granted in the knowledge of the possible consequences) was completed for the use of psychotropic medications. - Monitor for specific target behaviors when using the psychotropic medications. - Monitor for potential side effects (undesirable effect) of psychotropics medications. - Ensure a Psychiatric (is a medical doctor who specializes in the mental health field) consult for evaluation of the patient’s mental status and examination prior to prescribing the psychotropic medications. This deficient practice placed Patients 5 and 7 at risk for adverse drug reactions (unexpected negative reaction) that could jeopardize patient’s health and safety. A review of Patient 5’s clinical record indicated a start of care date (SOC) of 4/20/21, with diagnosis that included fibromyalgia (widespread muscle pain and tenderness). A review of Patient 5’s Home Health Certification and Plan of Care (POC) for the certification period starting from 12/6/23 to 2/3/23, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. One of the physician’s order included in the POC was to administer Quetiapine Fumarate (Seroquel, a psychotropic medication [any drug that affects mental function, behavior, and mood]) 25 mg (milligrams) one tablet daily for mental/mood disorder. A review of Patient 5’s clinical record indicated there was no documentation to indicate the use of Seroquel medication. There was no signed informed consent (permission granted in the knowledge of the possible consequences) completed for the use of psychotropic medications. There was no monitoring for specific target behavior and potential side effects (undesirable effect) of the psychotropic medications. There was no evidence for referral to be consulted by a Psychiatrist (is a medical doctor who specializes in the mental health field) for evaluation of the patient’s mental status and examination prior to prescribing the psychotropic medications. During an interview and concurrent record review with the DPCS on 12/18/23, at 1:00 p.m., the DPCS stated there was no informed consent for the use of psychotropic medications for Patient 5. The DPCS stated there was no documented evidence for the monitoring, tracking of specific behaviors, and the side effects of the Seroquel. The DPCS further stated there was no psychiatric consult to evaluate the mental status prior prescribing Seroquel medication to Patient 5. A review of the hospice agency’s policy and procedure “Psychotropic Medications” indicated that the hospice patients that reside in a skilled nursing facility must not receive psychotropic medication unless the medication is needed to treat a specific diagnosed and documented condition. A review of the agency’s undated policy and procedure titled, “The Plan of Care”, indicated a written individualized patient and family/caregiver plan of care will be established and maintained for each individual admitted to the hospice program. The care provided to the patient must be in accordance with the plan of care. According to the U.S. Food and Drug Administration (FDA) website, elderly patients with dementia (loss of memory and other mental abilities severe enough to interfere with daily life), related psychosis (a severe mental condition in which thought, and emotions are so affected that contact is lost with external reality) treated with antipsychotic (a group of psychotropic medications prescribed for the treatment of certain mental disorders) drugs are at an increased risk of death. The FDA indicated consideration should be given to a slower rate of dose titration (changes to medication doses to achieve the best clinical response and a lower target dose) in the elderly. The FDA indicated Seroquel was for the treatment of schizophrenia (a mental disorder involving a breakdown in the relation between thought, emotion, and behavior, leading to faulty perception, inappropriate actions and feelings, withdrawal from reality and personal relationships) and bipolar disease (a mental condition marked by alternating periods of elation and depression[sadness). For elderly use to consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf 2. A review of Patient 7’s Patient Profile Information indicated the SOC for patient was 5/11/2018 with the certification period reviewed for 12/1/2023 to 2/08/2023. Patient 7’s diagnosis is Type 2 diabetes ( a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel) with hyperglycemia (elevated blood sugar levels), Parkinson’s disease ( a progressive disorder that affects the nervous system and the parts of the body controlled by the nerves) and major depressive disorder (A mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life). A review of the document titled “Home Health Certification and Plan Of Care” for the certification period of 12/11/2023 to 2/8/2023 indicated that Clinical justification for need of continued home health services for Patient 7 includes patient needs daily insulin injections twice daily, caregiver unwilling to provide daily injections indicates it is too complex, unable to locate alternative caregiver for insulin administration after several attempts. The patient is extremely forgetful, has visual problems, and poor dexterity of hands due to Parkinson’s Disease, hand tremors and is unable to self-administer insulin. Mental Status: Mood: Depressed, Agitated, Irritable, Anxious. Behavioral: Assaultive, Impaired judgement, Impulsive, Poor coping skills, Poor decision making. Psychosocial: Pt baseline is alert and agitated, with forgetfulness and confusion. Patient is oriented to self, familiar people, but unwilling to have new Registered Nurse give care today. Became combative when blood sugar and insulin attempted. SN to instruct the Patient/Caregiver on medication regimen dose, indications, side effects, and interactions. SN to assess the Patient/caregiver administering injectable medications to determine if proper technique is utilized. SN to assess blood sugar via finger stick every visit prior to insulin administration. A home visit was conducted on 12/16/2023 at 2:44 p.m., with LVN 1. Patient 7 was observed to slowly walking using an assistive device, alert to name, person and place, not in any respiratory distress. Patients daughter was present during the home visit. During an interview the patient’s daughter at the home visit on 12/16/23, patient’s daughter stated the doctor started him on a new medication Sertraline 25 milligrams 1 tablet daily (mg- unit of measurement) from his last appointment. The patients daughter expressed concern when the following medications were abruptly discontinued: 1. Quetiapine Fumarate 25 mg at night for parkinson’s 2. Ropirinole 25 mg at bedtime for parkinson’s 3. Nortriptyline 10 mg daily for depression 4. Mirtazapine 30 mg daily for depression and anxiety A request was made form the Administrator (Admin) and the Interim Director of Nursing (IDON) for any communication notes regarding the discontinuation of psychotropic medication and physician notification for the discontinuation of medications. There was no written evidence in the plan of care for the continuous monitoring and management for psychotropics. medications. A review of the HHA’s policy titled “ Developing A Plan To Meet The Client Needs” dated 4/2/2021 indicated 11. A patient’s/client’s individualized plan of care/service plan at a minimum includes, When required by law, regulation or contract, orders (i.e., discipline, frequency and duration) from the physician or allowed practitioner (e.g., NP (nurse practitioner, PA (Physician Assistant, CNS (clinical nurse specialist) including patient/client specific and disease specific parameters defining when to notify the physician or allowed practitioner (e.g., NP, PA, CNS) of significant changes; The designated employee collaborates with the patient/client, representative (if any), and caregiver(s) as well as the patient’s physician or allowed practitioner (e.g., NP, PA, CNS) if applicable, to define a plan of care/service plan. Upon the patient’s/client’s admission to the home care, the DHCS or designee documents a plan of care/service plan that incorporates the specific patient’s needs, goals, barriers and assets, and the mode of care-delivery and required resources into the plan of care, including: Patient-specific measurable outcomes and goals; and Patient and caregiver education and training specific to the patient’s care needs. Patient specific and disease specific parameters are identified of when to notify the physician or allowed practitioner (e.g., NP, PA, CNS) of significant changes.”

“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 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 plan of care (POC) contained the management and monitoring of the use of psychotropic medications (any drug that affects mental function, behavior, and mood) for two of 9 sampled patients (Patient 5 and 7). - HHA failed to ensure the indications for the use of psychotropic medications for the identified problem and potential side effects (undesirable effect) of psychotropics medications. - HHA failed to ensure a signed informed consent (permission granted in the knowledge of the possible consequences) was completed for the use of psychotropic medications. - HHA failed to monitor for specific target behaviors when using the psychotropic medications. - HHA failed to ensure a psychiatric (is a medical doctor who specializes in the mental health field) consult for evaluation of the patient’s mental status and examination prior to prescribing the psychotropic medications. This deficient practice placed Patients 5 and Patient 7 at risk for adverse drug reactions (unexpected negative reaction) and unidentified changes on the patients’ health status that could jeopardize patient’s health and safety. During a review of Patient 5’s Personal Information indicated a start of care date (SOC) of 4/20/2021, with diagnosis that included fibromyalgia (widespread muscle pain and tenderness). During a review of Patient 5’s Home Health Certification and Plan of Care (POC) for the certification period starting from 12/6/2023 to 2/3/2023, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. One of the physician’s order included in the POC was to administer Quetiapine Fumarate (Seroquel, a psychotropic medication [any drug that affects mental function, behavior, and mood]) 25 mg (milligrams) one tablet daily for mental/mood disorder. During a review of Patient 5’s clinical record indicated there was no documentation that indicated of the use of Seroquel medication. There was no signed informed consent (permission granted in the knowledge of the possible consequences) completed for the use of psychotropic medications. There was no monitoring for specific target behavior and potential side effects (undesirable effect) of the psychotropic medications. There was no evidence for referral to be consulted by a Psychiatrist (is a medical doctor who specializes in the mental health field) for evaluation of the patient’s mental status and examination prior to prescribing the psychotropic medications. During an interview and concurrent record review with the DPCS on 12/18/2023, at 1:00 p.m., the DPCS stated there was no informed consent for the use of psychotropic medications for Patient 5. The DPCS stated there was no documented evidence for the monitoring, tracking of specific behaviors, and the side effects of the Seroquel. The DPCS further stated there was no psychiatric consult to evaluate the mental status prior prescribing Seroquel medication to Patient 5. A review of the hospice agency’s policy and procedure “Psychotropic Medications” indicated that the hospice patients that reside in a skilled nursing facility must not receive psychotropic medication unless the medication is needed to treat a specific diagnosed and documented condition. A review of the agency’s undated policy and procedure titled, “The Plan of Care”, indicated a written individualized patient and family/caregiver plan of care will be established and maintained for each individual admitted to the hospice program. The care provided to the patient must be in accordance with the plan of care. According to the U.S. Food and Drug Administration (FDA) website, elderly patients with dementia (loss of memory and other mental abilities severe enough to interfere with daily life), related psychosis (a severe mental condition in which thought, and emotions are so affected that contact is lost with external reality) treated with antipsychotic (a group of psychotropic medications prescribed for the treatment of certain mental disorders) drugs are at an increased risk of death. The FDA indicated consideration should be given to a slower rate of dose titration (changes to medication doses to achieve the best clinical response and a lower target dose) in the elderly. The FDA indicated Seroquel was for the treatment of schizophrenia (a mental disorder involving a breakdown in the relation between thought, emotion, and behavior, leading to faulty perception, inappropriate actions and feelings, withdrawal from reality and personal relationships) and bipolar disease (a mental condition marked by alternating periods of elation and depression[sadness). For elderly use to consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element 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 for the license nurses to obtain wound care orders for one out of 9 sampled patients ( Patient 4). This deficient practice placed the patient’s wound at risk for slow wound healing. A review of Patient 4’s Personal Information sheet indicated a start of care date (SOC) of 6/30/2022, with diagnosis that included encounter of removal of non surgical wound dressing. A review of Patient 4’s re-certification OASIS (to determine the need for nursing services) dated 10/19/2023, indicated under the Integumentary Status section the patient had a Stage 4 sacral pressure sore measuring three inches in length by three inches in width by three inches in depth without drainage and a right lateral ankle surgical wound measuring 1.5 inches in length by 0.5 inches in width without drainage. The SN (skilled nurse) intervention was wound care was provided on both open wound sites by cleansing with wound cleanser, patted dry, applied Aqua gel AG and Kerlix, covered with ABD pads and secured with tape. A review of Patient 4’s Home Health Certification and Plan of Care (POC) for the certification period starting from 10/23/2023 to 12/21/2023, included an order for the skilled nurse (SN) frequency of visits of once a week for 9 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. However, there was no physician’s order for wound care included in the POC. A further review of Patient 4’s clinical record indicated no documented evidence of a wound care order was obtain from the physician. On 12/18/2023, at 1 p.m., during an interview with the DPCS (director of patient care services), she stated the license nurses forgot to obtain wound care orders but they will call the physician for wound care orders now.”

“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 observations, interviews and record reviews, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed ensure that the physician review and revise the individualized plan of care that reflect the patient’s current health status for two out of 9 sampled patients (Patient 6 and 7). This deficient practice had the potential for the delayed in providing care based on the their needs to meet the patient care goals. 1. A review of Patient 6’s Patient Profile Information indicated, a start of care (SOC) date of 7/24/2023, with a certification period reviewed of 11/21/2023 to 1/19/2023. Patient 6’s diagnosis included hypothyroidism (happens when the thyroid gland doesn’t make enough thyroid hormone (a body hormone that helps regulate body temperature, heart rate and metabolism) and Alzheimer’s disease (a type of dementia that affects memory, thinking and behavior that can affect activities of daily life). Skilled nursing visit for once a week for one week and as needed for resumption/recertification or discharge. Physical Therapy for evaluation and treatment. A review of Patient 6’s “ Home Health Certification and Plan of Care” for the period of 11/21/2023 to 1/19/2023 indicated that the clinical justification for need of continued home health services for Patient 6 included, the patient/caregiver need reinforce teaching on areas of knowledge deficit. Continued physical therapy and skilled intervention needed to decrease risk & further complications through early intervention if changes occur and detailed instruction regarding: medications, disease process, proper care and management of patient with complex medical history. SN to instruct Patient/caregiver to protect patient’s feet from extreme heat or cold. Skilled Nursing (SN) to assess pain level and effectiveness of pain medications and current pain management therapy every visit. SN to instruct patient on nonpharmacologic pain relief measures, including relaxation techniques. SN to report to physician if patient experiences pain level not acceptable to patient, pain level greater than 6/10, pain medications not effective, patient unable to tolerate pain meds, pain affecting ability to perform patient’s normal activities. SN to assess skin for breakdown every visit. A home visit was conducted on 12/16/2023 at 3:00 p.m., with Licensed Vocational Nurse 1(LVN 1). Patient 1 was observed to walking using a walker , forgetful, unable to finish and complete sentences, alert to name, not in any respiratory distress. Patients daughter was present during the home visit. During an interview 12/16/2023 with the patients daughter during the home visit, Patients daughter stated that she drives the patient to her doctors appointments. Patient’s daughter stated that the neurologist ordered weekly blood work to check her CK levels (creatine kinase- This test measures the amount of creatine kinase (CK) in your blood. High CK levels may be a sign of damage or disease in your muscles) once a week for three weeks. Patient’s daughter stated that patient has another appointment with the doctor next week for the results. Patients daughter stated she told the visiting nurse of this blood work. Patients daughter expressed concern that the visiting nurse informed her that a supervising nurse will come and assess the patient. When the supervising nurse came she was told that the patient would be discharged from the program. 2. A review of Patient 7’s Patient Profile Information indicated the SOC for patient was 5/11/2018 with the certification period reviewed for 12/1/2023 to 2/08/2023. Patient 7’s diagnosis is type 2 diabetes ( a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel) with hyperglycemia (elevated blood sugar levels) and Parkinson’s disease ( a progressive disorder that affects the nervous system and the parts of the body controlled by the nerves). A review of the document titled “Home Health Certification and Plan Of Care” for the certification period of 12/11/2023 to 2/8/2023 indicated that clinical justification for need of continued home health services for Patient 7 includes patient needs daily insulin injections twice daily, caregiver unwilling to provide daily injections indicates it is too complex, unable to locate alternative caregiver for insulin administration after several attempts. The patient is extremely forgetful, has visual problems, and poor dexterity of hands due to Parkinson’s disease, hand tremors and is unable to self-administer insulin. Trial run of self-administration of insulin was not successful as patient was not administering insulin consistently or with the correct technique. Continued skilled intervention needed to decrease risk and further complications through early intervention if changes occur and detailed instruction regarding: proper care & management of patient with complex medical history. SN daily visits for 60 days. SN to assess skin for breakdown every visit. SN to instruct Patient/caregiver on all aspects of diabetic management to include disease process, foot assessments, signs and symptoms of hypo/hyperglycemia, glucometer use and preparation and administration of diabetic medications ordered by physician. SN to assess blood sugar via finger stick every visit prior to insulin administration. SN to check prepare and administer: Victoza subcutaneous 18 MG/3ML give 1.2mg subcutaneously Daily in AM and; Toujeo solostar subcutaneous 300 UNIT/ML inject 40 units subcutaneously Daily in AM. SN to instruct the patient the following symptoms could be signs of a heart attack: chest discomfort, discomfort in one or both arms, back, neck, jaw, stomach, shortness of breath, cold sweat, nausea, or dizziness. Instruct patient on signs and symptoms that necessitate calling 911. SN to monitor vital signs and report any abnormal findings to MD. SN to instruct the Patient/Caregiver on signs/symptoms of UTI to report to MD/SN. SN may obtain urinalysis and urine culture and sensitivity (c&s) test as needed for signs/symptoms of UTI(urinary tract infection), to include pain, foul odor, cloudy or blood-tinged urine and fever. SN to instruct Patient/Caregiver on Low sodium, Low Fat, Low cholesterol, No Concentrated sweets, Heart Healthy diet. SN to assess patient for diet compliance. SN to assess for patient adherence to appropriate activity levels. SN to instruct the Patient/Caregiver on proper ROM exercises and body alignment techniques. SN to instruct on safety measures: proper use of assistive devices, proper footwear, slow position changes, report dizziness, removal of clutter, remove throw rugs or tape them down, use non-skid mats in tub/shower, adequate lighting, notify agency/Medical Doctor for any falls/injury or call 911 for serious injury. SN to instruct the Patient/Caregiver on medication regimen dose, indications, side effects, and interactions. SN to assess the Patient/caregiver administering injectable medications to determine if proper technique is utilized. SN to assess blood sugar via finger stick every visit prior to insulin administration. A home visit was conducted on 12/16/2023 at 2:44 p.m., with LVN 1. Patient 7 was observed to slowly walking using an assistive device, alert to name, person and place, not in any respiratory distress. Patients daughter was present during the home visit. During an interview with the patients daughter during the home visit stated that the visiting nurse comes in daily at 10:00 a.m. to administer the insulin and check his blood sugar. Patient’s daughter expressed concern when the visiting nurse stated that her supervisor will come and assess the patient on the next home visit. Patients daughter stated that the supervising nurse came and did not check the patients blood sugar and did not administer the patients insulin. Patient’s daughter stated that the supervising nurse told her that she does not check insulin and does not administer insulin. Patients daughter stated that the supervising nurse left without doing anything. A request was made to both Interim Director of Nursing (IDON) and Administrator (Admin) to show any written evidences in Patient 6’s and Patient 7’s electronic medical record (EMR) regarding 60 or 90 days case summary or interdisciplinary team meetings. During an interview with both the Admin and the IDON on 12/18/2023 at 11:45 a.m., stated they do not have 60 or 90 days case summaries but conducts the stand-up meetings is every day at 9:00 a.m. via zoom and whoever is in the office. Admin further stated the nurses come in the office all the time and that is the time they communicate to the IDON and if there’s an urgent need to speak to the doctor for any patient inquiries, the nurses call to the office. A review of the HHA’s policy titled “ Developing A Plan To Meet The Client Needs” dated 4/2/2021 indicated 11. A patient’s/client’s individualized plan of care/service plan at a minimum includes, When required by law, regulation or contract, orders (i.e., discipline, frequency and duration) from the physician or allowed practitioner (e.g., NP (nurse practitioner, PA (Physician Assistant, CNS (clinical nurse specialist) including patient/client specific and disease specific parameters defining when to notify the physician or allowed practitioner (e.g., NP, PA, CNS) of significant changes; The designated employee collaborates with the patient/client, representative (if any), and caregiver(s) as well as the patient’s physician or allowed practitioner (e.g., NP, PA, CNS) if applicable, to define a plan of care/service plan.”