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

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the California Department of Public Health: Health Facilities Evaluator Nurse # 44911 Health Facilities Evaluator Nurse # 45783 Unduplicated Admissions - 49 Active Patients - 34 Sample Size - 7 Patients Home Visits – 3

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to identify medication accuracy for three of seven sampled patients, (Patient 1, 2, and 4). This deficient practice had the potential for the patients to take their medications other than ordered and experience adverse reactions. Findings: a. A review of Patient 1’s profile indicated a Start of Care (SOC) date of 6/11/2020 with a primary diagnosis of pressure ulcer (injuries to skin and underlying tissue resulting from prolonged pressure on the skin) stage II (the skin breaks open, wears away, or forms an ulcer, which is usually tender and painful) of sacral region (region below the spine and above the tailbone) and secondary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high), foot drop (a general term for difficulty lifting the front part of the foot), and pain in the left knee. A review of Patient 1’s Plan of Care (POC, documents the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period from 1/27/2023 to 3/27/2023 indicated Skilled Nurse (SN) to visit once a week for nine weeks to provide comprehensive assessment and observation of all organ systems, to review and reconcile patient’s medications every visit, assess patient/patient caregiver (PCG) comprehension of and compliance with medication regimen and response to medications. A review of Patient 1’s Medication Profile printed on 2/15/2023 indicated the patient is taking the following medications: - Allergy Relief 10 mg tablet daily (seasonal allergy medication) - Dextromethorphan HBr and Guaifenesin 10mg-200mg/5 milliliters (ml, unit of volume) solution, take one teaspoon (tsp) every four hours (medication used to relieve chest congestion and calming a cough) - Elliquis 5mg tablet, one tablet by mouth twice daily (blood thinner medication) - Hydrocortisone 1% in Absorbase topical ointment, apply to affected area (AAA) daily as needed (medication used to reduce inflammation in a non-prescription topical ointment used as a skin therapy, protectant, and moisturizer) - Hydrocortisone 1% Maximum Strength topical cream (medication used to reduce inflammation) apply to affected area (AAA) as directed - Meloxicam 15mg tablet, one tablet by mouth every day (Nonsteroidal Anti-inflammatory Drugs, NSAID, medication used to relieve pain, reduce inflammation, and bring down a high temperature) - Mucinex DM 30mg-600mg Extended-Release tablet, take one tablet by mouth every 12 hours as needed for cough - Norco 10mg-325mg tablet, one tablet by mouth every four hours as needed (a combination of two medications that work together to treat pain) - Tramadol Hydrochloride (HCL) 50mg tablet, one tablet by mouth twice daily (medication used to treat moderate to server pain in adults) - Trazadone HCL 50mg tablet, take one tablet by mouth daily (medication used to treat depressive disorder, anxiety disorders, and difficulties with sleep) - Triamcinolone Acetonide 0.1% topical cream, AAA three times a day as needed (medication used to relieve skin irritation, rashes, and infections) - Tylenol Extra Strength 500mg caplet, two caplets by mouth three times a day as needed (medication used to treat pain and reduce high temperature) - Ventolin 90 micrograms (mcg, unit of weight)/actuation inhalation aerosol two puffs respiratory inhalation every six hours as needed for shortness of breath - Voltaren 1% topical gel, AAA twice daily (topical medication used to treat inflammation and pain) On 2/16/2023 at 10:05 AM, a home visit was conducted with Licensed Vocational Nurse (LVN) 1 at Patient 1’s home residence. Patient 1 was lying in a hospital bed in the bedroom with patient’s daughter/PCG in the home. During a concurrent interview and record review on 2/16/2023 at 10:35 AM with Patient 1’s PCG and LVN 1 of Patient 1’s medications and Medication Profile, the following discrepancies were identified: - Allergy Relief medication was not present in the patient’s home - Dextromethorphan HBr and Gauifenesin medication was not present in the patient’s home - Elliquis medication, pharmacy label missing from medication bottle - Hydrocortisone 1% in Absorbase ointment was expired since 5/2022 - Hydrocortisone 1% maximum-strength topical cream was not present in the patient’s home - Meloxicam 15mg, medication was not present in the patient’s home - Mucinex DM medication was not present in the patient’s home - Norco 10mg-325mg, PCG says the patient does not take this medication - Tramadol HCL 50mg medication was not present in the patient’s home - Trazadone HCL 50mg medication was not present in the patient’s home - Triamcinolone Acetonide 0.1% topical cream was not present in the patient’s home - Tylenol Extra Strength 500mg medication was not present in the patient’s home - Ventolin 90mcg inhalation medication was expired since 9/2021, PCG stated the patient does not use this medication. PCG stated the patient has not used this medication in a long time. - Voltaren 1% topical gel medication was not present in the patient’s home The following medications were present but were not listed on Patient 1’s current Medication Profile: - Vitamin C 500mg tablets, PCG stated this over-the-counter vitamin supplement was the PCG’s but she sometimes gave the patient one for vitamin supplement - Atorvastatin Calcium 40mg medication bottle present, PCG stated this medication bottle was in the medication storage box by mistake, PCG stated the patient does not take this medication - Guaifenesin 400mg medication is expired since 10/2022 Patient 1’s daughter/PCG stated some of the medications were finished and she did not refill them. PCG stated that some of the medications were missing because she had not had a chance to go to the pharmacy to pick them up. During an interview on 2/16/2023 at 10:45 AM with LVN 1, LVN 1 stated she did not have a current Medication Profile for Patient 1 during the home visit. LVN 1 stated she should have a current Medication Profile with her during the home visit to review the patient’s medications in the home and to identify any discontinued or new medications. LVN 1 stated this is important to make sure the patient is taking the proper therapy and to identify any side effects and adverse reactions. During an interview on 2/17/2023 at 10:39 AM with Director of Patient Care Services (DPCS), DPCS stated the SN should be checking, reconciling, and monitoring the patient’s medications for effectiveness and assisting with medication administration if needed during every SN home visit. DPCS stated the LVN 1 should have had a current Medication Profile during Patient 1’s SN home visit on 2/16/2023 so the SN may review the patient’s current medications in the home that have been ordered and to check for patient compliance. b. A review of Patient 2’s profile indicated a Start of Care (SOC) date of 3/18/2021 with a primary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high) and secondary diagnoses of essential (primary) hypertension (HTN, high blood pressure). A review of Patient 2’s POC for certification period from 1/7/2023 to 3/7/2023 indicated SN to visit once a week for nine weeks to provide comprehensive assessment and observation of all organ systems, patient/PCG comprehension of and compliance with medication regimen and response to medications. The POC indicated Patient 2 was prescribed Tylenol 500mg by mouth, two tablets every hours as needed for pain. The POC does not indicate how often to take the medication. A review of Patient 2’s Medication Profile printed on 2/16/2023 indicated the patient is taking Tylenol 500mg two tablets by mouth every hours as needed for pain. The profile does not indicate how often to take the medication. During a concurrent interview and record review on 2/17/2023 at 10:39 AM with Director of Patient Care Services (DPCS) of Patient 2’s POC and Medication Profile, DPCS verified the POC order for Tylenol is missing the frequency and Patient 2’s Medication Profile is missing the frequency for Tylenol order. DPCS stated this was probably a mistake but both documents should indicate the frequency so that the patient knows how often to take the medication to receive the proper therapy. A review of the HHA’s policy and procedure (P&P) titled, “Medication Monitoring”, revised 3/2018, indicated agency staff will monitor each patient’s response to medications, including actual or potential medication related problems. The P&P indicated medication monitoring includes ascertaining the patient’s perceptions regarding side effects and medication effectiveness and utilizing available information including medication profile. A review of the HHA’s P&P titled, “Medication Labels”, revised 3/2018, indicated staff will assure that patients’ medications are appropriately labeled. The P&P indicated agency staff will review patient’s medications at time of admission and on an ongoing basis. The P&P indicated each medication should be labeled with medication name, strength, dose, frequency, and expiration date. c. A review of Patient 4’s clinical record indicated a start of care date (SOC) of 12/3/2022 with a primary diagnosis of type 2 diabetes with diabetic peripheral angiopathy with gangrene (Diabetic peripheral angiopathy is a blood vessel disease caused by high blood glucose or known as diabetes; it is one of the most common complications of uncontrolled diabetes. Gangrene is a type of tissue death caused by a lack of blood supply; symptoms may include a change in skin color to red or black, numbness, swelling, pain, skin breakdown, and coolness). A review of Patient 4's “Home Health Certification and Plan of Care” for the certification period of 2/1/2023 to 4/1/2023, indicated the physician ordered the skilled nurse (SN) to visit daily and as needed for 60 days, starting 2/1/2023. The SN was to set up medications weekly to aid the patient/caregiver in medication administration and compliance. The “Home Health Certification and Plan of Care” indicated patient/caregiver needs reinforcement regarding diabetes management, diet modifications, medication compliance, and wound care. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 2/16/2023 at 10:05 a.m., Patient 4 was observed sitting in a wheelchair, alert and awake. Patient 4 had Caregiver 1 (PCG 1) next to her. PCG 1 stated he assisted Patient 4 with activities of daily living (activities related to personal care, such as bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating). PCG 1 also assisted Patient 4 with preparing and administering her medications. Upon medication review with LVN 2, it was noted Patient 1’s medication list included the following medications: - Clopidogrel 75 Mg Tablet Oral, 1 Tablet daily. - Gabapentin 300 Mg Capsule Oral, 1 Tablet three times a day. Clopidogrel 75 Mg Tablet Oral was not found at Patient 4’s home. PCG 1 stated the physician had previously discontinued Clopidogrel 75 Mg Tablet and Patient 4 no longer had it at home. PCG 1 also stated Clopidogrel 75 Mg Tablet was discontinued “about a month ago.” The label on Gabapentin at the home indicated it was Gabapentin 100 Mg Capsule oral, 1 capsule three times a day. The date filled on the label was 2/7/2023. During interview with LVN 2 on 2/16/2023 at 11:20 a.m., LVN 2 stated, “The Gabapentin dose was changed recently to 100 Mg but it used to be 300 Mg, so that’s why it’s not updated on the medication profile.” LVN 2 stated the dose was changed around the fill date on the label, which was 2/7/2023. When asked about how often the medication profile is updated, LVN 2 stated, “I usually check every 2 weeks. I would ask them if there were any changes in the medication. Or if they just came back from doctor appointment, I’ll ask them if there are any changes.” LVN 2 stated she was not aware regarding the discontinuation of Clopidogrel 75 Mg. There were also two medications taken by Patient 4 but were not included in the medication profile: - Sevelamer Carbonate 800 Mg. Take 2 tablets by mouth three times a day with meals and 1 tablet with snacks. - Eliquis 2.5 Mg. Take 1 tablet by mouth twice a day. During interview with PCG 1 on 2/16/2023, PCG 1 stated Patient 4 has been taking Sevelamer Carbonate 800 Mg “for a long time.” PCG 1 also stated Patient 4 is taking Eliquis 2.5 Mg and it was not a new medication. LVN 2 stated she did not know why Sevelamer Carbonate 800 Mg and Eliquis 2.5 Mg were not listed in the medication profile, because they were listed in Patient 4’s Plan of Care. LVN 2 said both medications needed to be in patient’s medication profile. LVN 2 also stated it was important that patients have a current and updated medication profile, “To make sure they take the medications that MD prescribed, they understand the purpose, dose, the time, the side effects.” During interview with the Director of Patient Care Services (DPCS) on 2/17/2023 at 2 p.m., DPCS stated, “With each visit, the nurse should be asking the patient if there’s a new medication, or changed dose, or discontinued medication, then the nurse should update the patient’s medication profile at home. An addendum will be created at the office for their chart.” A review of the HHA’s policy, titled “Medication Labels,” revised March 2018, indicated “Agency staff will review patient’s medications at time of admission and on an ongoing basis.”

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to assess the oxygen saturation (oxygen level in the system) as indicated in the Plan of Care (POC) for one of seven sampled patients, (Patient 2). This deficient practice had the potential to lead to the patient experiencing an unidentified change of respiratory condition. A review of Patient 2’s profile indicated a Start of Care (SOC) date of 3/18/2021 with a primary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high) and secondary diagnoses of essential (primary) hypertension (HTN, high blood pressure). A review of Patient 2’s Recertification Outcome and Assessment Information Set (OASIS, an instrument/data collection tool used to collect and report assessment data by home health agencies) dated 1/6/2023 indicated Patient 2 had dyspnea (difficulty breathing or shortness of breath) on minimal exertion (physical effort). A review of Patient 2’s POC for certification period from 1/7/2023 to 3/7/2023 indicated Skilled Nurse (SN) to visit once a week for nine weeks to assess patient’s vital signs (temperature, respiratory rate, heart rate, blood pressure, and oxygen saturation). During a concurrent interview and record review on 2/17/2023 at 10:39 a.m., with Director of Patient Care Services (DPCS) of Patient 2’s recertification OASIS, POC, and SN Visit Notes dated 1/10/2023, 1/19/2023, 1/24/2023, 1/31/2023, and 2/7/2023, DPCS verified that Patient 2’s recert OASIS indicated patient experienced dyspnea on minimal exertion. DPCS also verified Patient 2’s POC indicated SN to assess the patient’s vital signs which include assessing the oxygen saturation using pulse oximetry (O2 sat, noninvasive test that measures the oxygen saturation level of your blood, normal O2 sat is usually 95% or higher). DPCS verified Patient 2’s SN Visit Notes dated 1/10/2023, 1/19/2023, 1/24/2023, 1/31/2023, and 2/7/2023 all indicated Patient 2 experienced dyspnea on minimal exertion but no O2 sat was documented on the respiratory section of the SN notes. DPCS stated the SN notes should indicate the O2 sat was assessed. DPCS stated this is important to be able to assess what the patient’s current condition is to see if any additional therapy is needed. A review of the HHA’s policy and procedure titled, “Plan of Care-CMS#485 and Physician Orders”, revised 3/2018, indicated skilled nursing and other home health services will be in accordance with a Plan of Care based on the patient’s diagnosis and assessment of immediate and long-range needs and resources. The P&P indicated each patient must receive the home health services that are written in an individualized plan of care. The P&P indicated the individualized plan of care must include the types of services, supplies, and equipment required. The P&P indicated the care and services provided will be provided according to physician orders and orders are current and updated, services and treatments are administered by staff only as ordered by the physician. The P&P indicated all clinical services are implemented only in accordance with a plan of care established by a physician’s written order.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) staff failed to ensure the individualized plan of care included patient and caregiver specific education and training, for one of 7 sampled patients (Patient 4). This deficient practice had the potential to impede the patient’s/caregiver’s competence with self-management of disease process. A review of Patient 4’s clinical record indicated a start of care date (SOC) of 12/3/2022 with a primary diagnosis of type 2 diabetes with diabetic peripheral angiopathy with gangrene (Diabetic peripheral angiopathy is a blood vessel disease caused by high blood glucose or known as diabetes; it is one of the most common complications of uncontrolled diabetes. Gangrene is a type of tissue death caused by a lack of blood supply; symptoms may include a change in skin color to red or black, numbness, swelling, pain, skin breakdown, and coolness). A review of Patient 4's “Home Health Certification and Plan of Care” for the certification period of 2/1/2023 to 4/1/2023, indicated the physician ordered the skilled nurse (SN) to visit daily and as needed for 60 days, starting 2/1/2023. The SN was to set up medications weekly to aid the patient/caregiver in medication administration and compliance. The “Home Health Certification and Plan of Care” indicated patient/caregiver needs reinforcement regarding diabetes management, diet modifications, medication compliance, and wound care. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 2/16/2023 at 10:05 a.m., Patient 4 was observed sitting in a wheelchair, alert and awake. Patient 4 had Caregiver 1 (PCG 1) next to her. PCG 1 stated he assisted Patient 4 with activities of daily living (activities related to personal care, such as bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating). PCG 1 also assisted Patient 4 with checking her blood glucose, preparing, and administering her medications. During medication review, PCG 1 stated he always checked Patient 4’s blood glucose in the morning. Patient 4 is on Januvia 25 mg. Tablet Oral, 1 Tablet daily. It was noted that Patient 4 used Bayer Contour glucometer (a device for measuring the concentration of glucose in the blood, typically using a small drop of blood placed on a disposable test strip, where a chemical reaction with glucose alters the electrical conductivity of the strip) at home. The strip vial had an expiration date of 10/31/2023. There was no opening date on it. PCG 1 stated he did not know that once opened, the strips were only good for a certain amount of time, even if they were not yet expired. When asked the last time he calibrated the glucometer, PCG 1 replied, “I never did.” During interview with PCG 1 on 2/16/2023 at 11:30 a.m., PCG 1 stated he did not know what calibration meant. It was explained to PCG 1 that glucometer calibration was a quality control tests, typically using the control solution that came with the glucometer, to assure that the glucometer was working properly. During an interview with LVN 2 on 2/16/2023 at 11:35 a.m., LVN 2 stated it was important to label the strip vial with the opening date to ensure an accurate reading. LVN 2 also stated calibrating the glucometer was important as well to get an accurate reading. During an interview with Director of Patient Care Services (DPCS) on 2/17/2023, DPCS stated labeling the strip vial with the opening date was important to ensure that patient would get accurate results. DPCS also stated . DPCS also stated, “We’ll make sure that we put it in the care plan so the staff will educate the patient and the caregiver regarding the strips and glucometer calibration.” A review of the HHA’s policy, titled “Plan of Care -CMS #485 and Physician Order,” revised March 2018, indicated “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 disciplines and the measurable outcomes that the Agency 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. A review of Bayer Contour glucometer manual indicated to check the expiration and discard dates on the bottle. The manual also indicated to use Bayer’s Contour control solutions to run a check to make sure the meter and the test strips are working properly.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide ongoing education and training for two of 7 sampled patients, (Patient 4 and Patient 5). This deficient practice placed the patient at risk for medication errors, improper management of the disease, and improper administration of treatments. a. A review of Patient 4’s clinical record indicated a start of care date (SOC) of 12/3/2022 with a primary diagnosis of type 2 diabetes with diabetic peripheral angiopathy with gangrene (Diabetic peripheral angiopathy is a blood vessel disease caused by high blood glucose or known as diabetes; it is one of the most common complications of uncontrolled diabetes. Gangrene is a type of tissue death caused by a lack of blood supply; symptoms may include a change in skin color to red or black, numbness, swelling, pain, skin breakdown, and coolness). A review of Patient 4's “Home Health Certification and Plan of Care” for the certification period of 2/1/2023 to 4/1/2023, indicated the physician ordered the skilled nurse (SN) to visit daily and as needed for 60 days, starting 2/1/2023. The SN was to set up medications weekly to aid the patient/caregiver in medication administration and compliance. The “Home Health Certification and Plan of Care” indicated patient/caregiver needs reinforcement regarding diabetes management, diet modifications, medication compliance, and wound care. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 2/16/2023 at 10:05 a.m., Patient 4 was observed sitting in a wheelchair, alert and awake. Patient 4 had Caregiver 1 (PCG 1) next to her. PCG 1 stated he assisted Patient 4 with activities of daily living (activities related to personal care, such as bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating). PCG 1 also assisted Patient 4 with checking her blood glucose, preparing, and administering her medications. PCG 1 stated he always checked Patient 4’s blood glucose in the morning. Patient 4 is on Januvia 25 Mg Tablet Oral, 1 Tablet daily. It was noted that Patient 4 used Bayer Contour glucometer (a device for measuring the concentration of glucose in the blood, typically using a small drop of blood placed on a disposable test strip, where a chemical reaction with glucose alters the electrical conductivity of the strip) at home. When asked the last time he calibrated the glucometer, PCG 1 replied, “I never did.” During an interview with PCG 1 on 2/16/2023 at 11:30 a.m., PCG 1 stated he did not know what calibration meant. It was explained to PCG 1 that glucometer calibration was a quality control tests, typically using the control solution that came with the glucometer, to assure that the glucometer was working properly. PCG 1 stated the HHA staff never explained to him about calibration using the control solution. During an interview with LVN 2 on 2/16/2023 at 11:35 a.m., LVN 2 stated it was important to calibrate the glucometer to ensure accurate reading. When asked if she had provided education to Patient 4 or PCG 1 regarding calibration, LVN 2 stated “Probably not.” There is no documented evidence that education regarding glucometer calibration was provided to Patient 4 and/or PCG 1. During an interview with Director of Patient Care Services (DPCS) on 2/17/2023, DPCS stated calibrating the glucometer was important for accurate readings. DPCS also stated, “Education is an important part of home health services.” b. A review of Patient 5’s clinical record indicated a start of care date (SOC) of 11/18/2020 with a primary diagnosis of hypertensive heart disease without heart failure (this condition refers to heart problems that occur because of high blood pressure that is present over a long time; in this case the patient’s heart is still able to pump blood to deliver oxygen and nutrients to the body’s cells). A review of Patient 5's “Home Health Certification and Plan of Care” for the certification period of 1/7/2023 to 3/7/2023, indicated the physician ordered the skilled nurse (SN) to visit weekly and as needed, starting 1/7/2023. The SN was also to review and reconcile patient’s medications every visit, teach patient about ordered medications regarding effects, side effects, dosages and timing, effectiveness of current medications, compliance with ordered medications, diet/nutrition, and plan of treatment. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 2/16/2023 at 12 noon, Patient 5 was observed alert, awake, and ambulatory. During medication review, it was observed that three medications listed on the medications profile were not available at the patient’s house. Those medications were: - Norco 10/325 Mg Tablet Oral. 1 Tablet every 4 hours. - Omeprazole 40 Mg Delayed-Release Capsule Oral, once daily. - Vitamin D 5000 units Tablet Oral, daily. Patient 5 stated that Norco 10/325 Mg, Omeprazole 40 Mg Delayed-Release, and Vitamin D 5000 units were being refilled at the pharmacy. She stated she was going to have her caregiver pick them up for her. According to Patient 5, she took Omeprazole and Vitamin D every day, and Norco almost every day. Patient 5 stated, “Sometimes if I order them too early, the insurance doesn’t allow that. If I order late I’ll run out of medication.” During an interview with LVN 1 on 2/16/2023 at 12:35 p.m., LVN 1 stated she would remind Patient 5 to refill her medications before they run out in the future. A review of “SN Visit Note” dated 1/7/2023, 1/14/2023, 1/21/2023, and 2/24/2023, indicated there was no documented evidence of the HHA staff educating Patient 5 regarding the importance of refilling medications before she ran out of them. A review of the HHA’s policy, titled “Patient Education” revised March 2018, indicated “2. Based on patient’s condition, physician ordered care and assessed needs, patient/family will receive education, as appropriate, about: Plan of care, Medications, including safe and effective use,…, Medical equipment and/or supplies provided by Agency. 3. The patient education provided will be: Presented in a manner that the patient understands, coordinated among the disciplines providing care to the patient, appropriate to the patient’s abilities, evaluated for patient’s comprehension, documented.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide a written copy of the Plan of Care (POC) for three of seven sampled patients, (Patient 1, 4, and 5). These deficient practices had the potential for the patients to not know their treatment plan, not know the services provided by the HHA, and not be an active participant in their care planning process. Findings: a. A review of Patient 1’s profile indicated a Start of Care (SOC) date of 6/11/2020 with a primary diagnosis of pressure ulcer (injuries to skin and underlying tissue resulting from prolonged pressure on the skin) stage II (the skin breaks open, wears away, or forms an ulcer, which is usually tender and painful) of sacral region (region below the spine and above the tailbone) and secondary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high), foot drop (a general term for difficulty lifting the front part of the foot), and pain in the left knee. A review of Patient 1’s Plan of Care (POC, documents the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period from 1/27/2023 to 3/27/2023 indicated Skilled Nurse (SN) to visit once a week for nine weeks to provide comprehensive assessment and observation of all organ systems, patient/patient caregiver (PCG) comprehension of and compliance with medication regimen and response to medications. On 2/16/2023 at 10:05 AM, a home visit was conducted with Licensed Vocational Nurse (LVN) 1 at Patient 1’s home residence. Patient 1 was lying in a hospital bed in the bedroom with patient’s daughter/PCG in the home. During a concurrent observation, interview and record review on 2/16/2023 at 10:35 AM with Patient 1’s daughter/PCG of the patient’s HHA home folder in Patient 1’s residence, in review of the patient’s home folder, no POC was included in the home folder. PCG stated she may have it in another folder but was unable to locate the other folder. A review of the HHA’s policy and procedure (P&P) titled, “Plan of Care-CMS#485 and Physician Orders”, revised 3/2018, indicated each patient must receive an individualized written plan of care and the plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment. b. A review of Patient 4’s clinical record indicated a start of care date (SOC) of 12/3/2022 with a primary diagnosis of type 2 diabetes with diabetic peripheral angiopathy with gangrene (Diabetic peripheral angiopathy is a blood vessel disease caused by high blood glucose or known as diabetes; it is one of the most common complications of uncontrolled diabetes. Gangrene is a type of tissue death caused by a lack of blood supply; symptoms may include a change in skin color to red or black, numbness, swelling, pain, skin breakdown, and coolness). A review of Patient 4's “Home Health Certification and Plan of Care” for the certification period of 2/1/2023 to 4/1/2023, indicated the physician ordered the skilled nurse (SN) to visit daily and as needed for 60 days, starting 2/1/2023. The SN was to set up medications weekly to aid the patient/caregiver in medication administration and compliance. The “Home Health Certification and Plan of Care” indicated patient/caregiver needs reinforcement regarding diabetes management, diet modifications, medication compliance, and wound care. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 2/16/2023 at 10:05 a.m., there was no Plan of Care (POC) observed inside the patient’s home health folder. Patient’s caregiver (PCG 1) stated he was not aware if they were provided with a copy of the POC or not. PCG 1 stated, “All the paperwork is in there.” During an interview with LVN 2 on 2/16/2023 at 11 a.m., LVN 2 stated that providing patient with a copy of the POC was important “So they can be aware of how often the nurse is going to visit, the treatment they’re going to receive, and the care that is planned for them.” LVN 2 also stated the copy of POC is supposed to be inside the patient’s home folder. c. A review of Patient 5’s clinical record indicated a start of care date (SOC) of 11/18/2020 with a primary diagnosis of hypertensive heart disease without heart failure (this condition refers to heart problems that occur because of high blood pressure that is present over a long time; in this case the patient’s heart is still able to pump blood to deliver oxygen and nutrients to the body’s cells). A review of Patient 5's “Home Health Certification and Plan of Care” for the certification period of 1/7/2023 to 3/7/2023, indicated the physician ordered the skilled nurse (SN) to visit weekly and as needed, starting 1/7/2023. The SN was also to review and reconcile patient’s medications every visit, teach patient about ordered medications regarding effects, side effects, dosages and timing, effectiveness of current medications, compliance with ordered medications, diet/nutrition, and plan of treatment. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 2/16/2023 at 12 noon, there was no Plan of Care (POC) observed inside the patient’s home health folder. During an interview with LVN 1 on 2/16/2023 at 12:55 p.m., LVN 1 stated that patient was supposed to get a copy of the POC. LVN 1 stated, “It’s usually in their folder, but it’s not in there.” LVN 1 stated that it was important for patient to have a copy of the POC, “So that patient is aware of their plan of care, that way they can be compliant and they can participate in planning their care.” During an interview with the Director of Patient Care Services (DPCS) on 2/17/2023 at 2 p.m., the DPCS stated, “We have been providing the plan of care to the nurse, and the nurse is supposed to put it in the patient’s folder. I guess that’s not happening.” The DPCS also stated that if patient was not provided with a copy of the POC then “They wouldn’t be able to participate. If they’re discharged, they won’t know what to do if there’s an emergency, or signs/symptoms to report.” A review of the HHA’s policy, titled “Plan of Care – CMS #485 and Physician Orders,” revised March 2018, indicated “Each patient must receive an individualized written plan of care, including any revisions or additions.”

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide the patients with a current medication profile for two of seven sampled patients, (Patient 1 and 4). These deficient practices had the potential to lead to the patient’s receiving incorrect medications, experiencing adverse reactions, and not receiving the proper medication therapy. Findings: a. A review of Patient 1’s profile indicated a Start of Care (SOC) date of 6/11/2020 with a primary diagnosis of pressure ulcer (injuries to skin and underlying tissue resulting from prolonged pressure on the skin) stage II (the skin breaks open, wears away, or forms an ulcer, which is usually tender and painful) of sacral region (region below the spine and above the tailbone) and secondary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high), foot drop (a general term for difficulty lifting the front part of the foot), and pain in the left knee. A review of Patient 1’s Plan of Care (POC, documents the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period from 1/27/2023 to 3/27/2023 indicated Skilled Nurse (SN) to visit once a week for nine weeks to provide comprehensive assessment and observation of all organ systems, patient/patient caregiver (PCG) comprehension of and compliance with medication regimen and response to medications. On 2/16/2023 at 10:05 AM, a home visit was conducted with Licensed Vocational Nurse (LVN) 1 at Patient 1’s home residence. Patient 1 was lying in a hospital bed in the bedroom with patient’s daughter/PCG in the home. During a concurrent observation, interview and record review on 2/16/2023 at 10:35 AM with Patient 1’s daughter/PCG of the patient’s HHA home folder in Patient 1’s residence, in review of the patient’s home folder, there was no current Medication Profile included in the home folder. PCG stated she may have it in another folder but was unable to locate the other folder. During an interview on 2/17/2023 at 10:39 AM with Director of Patient Care Services (DPCS), DPCS stated the HHA should provide Patient 1 with a current Medication Profile in the patient’s HHA home folder so that the patient and PCG are aware of what medications the patient is taking and how often the medications should be given. In review of the HHA’s policy and procedure (P&P) titled, “Patient Bill of Rights and Responsibilities”, revised 3/2018, the P&P indicated the patient to be informed of their visit schedule and frequency, patient medication schedule and instructions, and treatments to be administered by agency staff. b. A review of Patient 4’s clinical record indicated a start of care date (SOC) of 12/3/2022 with a primary diagnosis of type 2 diabetes with diabetic peripheral angiopathy with gangrene (Diabetic peripheral angiopathy is a blood vessel disease caused by high blood glucose or known as diabetes; it is one of the most common complications of uncontrolled diabetes. Gangrene is a type of tissue death caused by a lack of blood supply; symptoms may include a change in skin color to red or black, numbness, swelling, pain, skin breakdown, and coolness). A review of Patient 4's “Home Health Certification and Plan of Care” for the certification period of 2/1/2023 to 4/1/2023, indicated the physician ordered the skilled nurse (SN) to visit daily and as needed for 60 days, starting 2/1/2023. The SN was to set up medications weekly to aid the patient/caregiver in medication administration and compliance. The “Home Health Certification and Plan of Care” indicated patient/caregiver needs reinforcement regarding diabetes management, diet modifications, medication compliance, and wound care. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 2/16/2023 at 10:05 a.m., there was no medication profile observed inside the patient’s home health folder. Patient’s caregiver (PCG 1) stated he was not aware if the HHA staff provided them with a copy of the medication profile or not. PCG 1 stated, “All the paperwork is in there.” During an interview with LVN 2 on 2/16/2023 at 11 a.m., LVN 2 stated that providing patient with a copy of the medication profile was important. LVN 2 stated, “Medication profile is important especially if there are any changes or if there is a new medication which the doctor has ordered. The patient and caregiver can always refer to the medication profile.” LVN 2 also stated the medication profile needed to be placed inside the patient’s home health folder. During an interview with the Director of Patient Care Services (DPCS) on 2/17/2023 at 2 p.m., the DPCS stated the HHA needed to provide patients with a copy of the medication profile and that failing to do so put patients at risk for medication error. A review of the HHA’s policy, titled, “Patient Bill of Rights and Responsibilities”, revised March2018, indicated that the patient was to be informed of their visit schedule and frequency, patient medication schedule and instructions, and treatments to be administered by agency staff.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to adhere to standard precautions and infection control practices during wound care for one of ten sampled patients, (Patient 1). This failure had the potential for cross contamination of the wound and can lead to the patient developing an infection and experience prolonged wound healing. A review of Patient 1’s profile indicated a Start of Care (SOC) date of 6/11/2020 with a primary diagnosis of pressure ulcer (injuries to skin and underlying tissue resulting from prolonged pressure on the skin) stage II (the skin breaks open, wears away, or forms an ulcer, which is usually tender and painful) of sacral region (region below the spine and above the tailbone) and secondary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high), foot drop (a general term for difficulty lifting the front part of the foot), and pain in the left knee. A review of Patient 1’s Plan of Care (POC, documents the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period from 1/27/2023 to 3/27/2023 indicated Skilled Nurse (SN) to visit once a week for nine weeks to provide comprehensive assessment and observation of all organ systems, continue to monitor integumentary (pertaining to a person’s outer layer, skin) system and notify doctor of changes. The POC indicated the SN to educate patient/patient caregiver (PCG) regarding the importance of good skin hygiene, turn patient every one to two hours to avoid skin trauma and to keep skin clean and dry. A review of Patient 1’s “Care Plans/Orders” dated 2/9/2023 indicated a doctor’s order for an increase in SN visit frequency to twice a week for one week, then three times a week for six weeks, and once a week for one week. The doctor order indicated SN to perform wound care to stage II pressure injury On 2/16/2023 at 10:05 a.m., a home visit was conducted with Licensed Vocational Nurse (LVN) 1 at Patient 1’s home residence. Patient 1 was lying in a hospital bed in the bedroom with patient’s daughter/PCG in the home. During an observation on 2/16/2023 at 10:26 a.m., of Patient 1’s wound care by Licensed Vocational Nurse (LVN) 1, LVN 1 donned non-sterile gloves to cleanse the patient’s wound and then proceeded to attach the new clean dressing to the patient’s wound without changing her gloves to a clean pair of gloves before applying the new clean dressing. During an interview on 2/16/2023 at 10:45 a.m., with LVN 1, LVN 1 stated she should have changed her gloves before applying the new clean dressing Patient 1’s wound. LVN 1 stated this is important to prevent any contamination of new clean dressing and the wound. During an interview of 2/17/2023 at 10:39 a.m., with Director of Patient Care Services (DPCS), DPCS stated the proper infection control method when providing wound care includes the SN to change their gloves between cleansing the wound and applying the new clean dressing. DPCS stated the gloves should be changed and hand hygiene should be performed to prevent any cross-contamination of the clean wound and dressing. During a concurrent interview and policy review on 2/17/2023 at 1:08 p.m., with DPCS of HHA’s policy and procedure (P&P) titled, “Application of Dry Dressing”, undated, the P&P indicated procedure included to don a second pair of gloves and clean the wound with prescribed solution and guaze pad, clean from least contaminated to most contaminated areas, and use a new pad for each stroke then apply ointment as ordered and apply dry sterile dressing. DPCS verified the P&P does not indicate to change gloves between cleansing the wound and applying ointment and new clean dry dressing. DPCS stated the P&P needed to be changed. A review of the HHA’s policy and procedure (P&P) titled, “Hand Hygiene Policy and Compliance Program”, revised 3/2018, the P&P indicated hand hygiene will be done by all employees to reduce the transfer of microbes to patients and to prevent the growth of microorganisms on the nails, hands, and forearms. The P&P indicated the indications for staff performing hand hygiene include after any contact with contaminated materials. The P&P indicated the use of gloves includes gloves should be changed or removed if moving from contaminated to clean patient site or the environment.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide patient/patient caregiver (PCG) education regarding medication regimen compliance and storage for one of seven sampled patients, (Patient 1). This deficient practice had the potential for the patient to receive improper medication therapy. A review of Patient 1’s profile indicated a Start of Care (SOC) date of 6/11/2020 with a primary diagnosis of pressure ulcer (injuries to skin and underlying tissue resulting from prolonged pressure on the skin) stage II (the skin breaks open, wears away, or forms an ulcer, which is usually tender and painful) of sacral region (region below the spine and above the tailbone) and secondary diagnosis of diabetes mellitus (DM, a disease in which blood sugar levels are too high), foot drop (a general term for difficulty lifting the front part of the foot), and pain in the left knee. A review of Patient 1’s Plan of Care (POC, documents the process of identifying a patient’s needs and facilitating holistic care and ensures collaboration among nurses, patients, and other healthcare providers) for certification period from 1/27/2023 to 3/27/2023 indicated Skilled Nurse (SN) to visit once a week for nine weeks to provide comprehensive assessment and observation of all organ systems, to review and reconcile patient’s medications every visit, teach patient/patient caregiver (PCG) about ordered medications regarding effects, side effects, dosages, and timing, and assess effectiveness of current medications, compliance with ordered medications. On 2/16/2023 at 10:05 a.m., a home visit was conducted with Licensed Vocational Nurse (LVN) 1 at Patient 1’s home residence. Patient 1 was lying in a hospital bed in the bedroom with patient’s daughter/PCG in the home. During a concurrent observation, interview, and record review on 2/16/2023 at 10:35 a.m., with Patient 1’s PCG and LVN 1 of Patient 1’s medications and Medication Profile, the following discrepancies were identified: o Allergy Relief medication was not present in the patient’s home o Dextromethorphan HBr and Gauifenesin medication was not present in the patient’s home o Elliquis medication, pharmacy label missing from medication bottle o Hydrocortisone 1% in Absorbase ointment was expired since 5/2022 o Hydrocortisone 1% maximum-strength topical cream was not present in the patient’s home o Meloxicam 15mg, medication was not present in the patient’s home o Mucinex DM medication was not present in the patient’s home o Norco 10mg-325mg, PCG says the patient does not take this medication o Tramadol HCL 50mg medication was not present in the patient’s home o Trazadone HCL 50mg medication was not present in the patient’s home o Triamcinolone Acetonide 0.1% topical cream was not present in the patient’s home o Tylenol Extra Strength 500mg medication was not present in the patient’s home o Ventolin 90mcg inhalation medication was expired since 9/2021, PCG stated the patient does not use this medication. PCG stated the patient has not used this medication in a long time. o Voltaren 1% topical gel medication was not present in the patient’s home The following medications were present but were not listed on Patient 1’s current Medication Profile: o Vitamin C 500mg tablets, PCG stated this over-the-counter vitamin supplement was the PCG’s but she sometimes gave the patient one for vitamin supplement o Atorvastatin Calcium 40mg medication bottle present, PCG stated this medication bottle was in the medication storage box by mistake, PCG stated the patient does not take this medication o Guaifenesin 400mg medication is expired since 10/2022 Patient 1’s daughter/PCG stated some of the medications were finished and she did not refill them. PCG stated that some of the medications were missing because she had not had a chance to go to the pharmacy to pick them up. An observation of Patient 1’s medication storage box with LVN 1 was noted to be unorganized with loose foil pill packs and a pair of scissors, empty weekly pill box, and one loose pill that was unable to be identified. LVN 1 asked PCG where the original medication boxes were and PCG stated she throws them away. During an interview on 2/16/2023 at 10:45 a.m., with LVN 1, LVN 1 stated she agrees the patient/PCG need more education regarding organizing the medications and making sure the patient’s daughter/PCG does not remove the pharmacy labels from the medication bottles. LVN 1 stated the importance of patient/PCG education make sure the patient receives the proper medication therapy, so they can identify any adverse reactions, and to know when to call the doctor about any side effects the patient may present. During an interview on 2/17/2023 at 10:39 a.m., with Director of Patient Care Services (DPCS), DPCS stated patient/PCG education should be done during every SN home visit to identify if there are any concerns with medication compliance, storage, or labeling. DPCS stated patient/PCG education is important to ensure the patient receives the proper medication therapy and avoid any adverse reactions. A review of the HHA’s policy and procedure titled, “Patient Education”, revised 3/2018, indicated agency staff will provide initial and ongoing education to meet each individual patient’s needs. The P&P indicated patient/family assessment of learning needs includes emotional barriers, religious and cultural barriers, communication barriers, cognitive and/or physical limitations, and desire and motivation of learn. The P&P indicated based on patient’s condition, physician ordered care and assessed needs, patient/family will receive education, as appropriate, about medications, including safe and effective use, basic health practices and safety, and basic physical and structural home safety. The P&P indicated the patient education provided will be presented in a manner that the patient understands, coordinated among the disciplines providing care to the patient, appropriate to the patient’s abilities, evaluated for patient’s comprehension, and documented.