Every finding on record at Happy Life Home Health Care, Inc

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record revies the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to revise one of ten sample patients (Patient 29) individualized plan of care to reflect current information. This failure had the potential to result in missed treatments and/or confusion about Patient 29’s current medical treatment. During a record review of Patient 29’s medical record form titled “Patient Information” undated, indicated a start of care date of 9/13/2024 with a primary diagnosis of atherosclerotic native arteries (plaque buildup on the arterial walls) of extremities with rest pain, right leg. During a record review on Patient 29’s Electronic Medical record (EMR) medical record form titled “History of Physician Order” indicated “Episode: EP #2 (11/12/2024-1/10/2025) – Date: 11/12/2024… Module: Re-Cert – Status: X.” During a record review of Patient 29’s medical record form titled “Home Health Certification and Plan of Care” dated from 9/13/2024 to 11/11/2024, indicated “Clarification of SN (skilled nurse) visits with MD (medical doctor) – SN 3W1 (three times per week for one week) effective on the week of 10/6/2024; daily LVN (License Vocational Nurse) visits for 2 weeks effective the week of 10/13/2024; RN (Register Nurse) visits every 2 weeks effective 10/13/2024; LVN frequency on the week of 3W1, 1W2 (one visit per week for two weeks).” Lastly, the form indicated the form was signed by Registered Nurse (RN3) on 10/10/2024. During a record review of Patient 29’s medical record form titled “Home Health Certification and Plan of Care” dated from 11/12/2024 to 1/10/2024, the form listed to following medication “Metformin… The form also indicated “Clarification of SN (skilled nurse) visits with MD (medical doctor) – SN 3W1 (three times per week for one week) effective on the week of 10/6/2024; daily LVN (License Vocational Nurse) visits for 2 weeks effective the week of 10/13/2024; RN (Register Nurse) visits every 2 weeks effective 10/13/2024; LVN frequency on the week of 3W1, 1W2 (one visit per week for two weeks).” Lastly, the form indicated “Episode 1, 9/13/2024 to 11/11/2024” and it was signed by RN3 on 11/11/2024. During a concurrent observation and interview on 11/13/2024 at 12 p.m., with Registered Nurse 3 (RN3) at Patient 29’s residence, RN3 stated she visits Patient 29 once a week and an LVN twice a week. During an interview and record review on 11/13/2024 at 12:45 p.m. with Patient 29’s care giver/daughter (CG2) of Patient 29’s HHA medication list, CG2 stated Patient 29’s Metformin medication was discontinued since 10/31/2024 by her primary doctor. During a concurrent interview and record review on 11/14/2024 at 1:40 p.m., with the Director of Patient Care Services (DPCS) of Patient 29’s Electronic Medical Record (EMR) medical record form titled “Home Health Certification and Plan of Care” dated from 11/12/2024 to 1/10/2024, the DPCS stated Patient 29’s recertification order should be completed within 48 hours of the start of the episode, which should be 11/12/2024.The DPCS stated Patient 29’s current plan of care was completed on 11/11/2024. The DPCS stated Patient 29’s plan of care was not updated and that the HHA had up to today (11/14/2024) to complete Patient 29’s plan of care.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure one of 10 sampled patients (Patient 33) receive education and training how to change the urinary drainage bag for the indwelling catheter (a tube that drains urine from the bladder). This failure resulted in Patient 33 having to visit the medical clinic to have the catheter care needs met. A record review of Patient 33’s Personal Information sheet indicated a start of care on 9/28/2024, with a primary diagnosis of prostate cancer. A record review of Patient 33’s document titled, “Home Health Certification and Plan of Care” for certification period 9/26/2024 to 11/26/2024, indicated the skilled nurse (SN) teaching included to teach and demonstrate to the patient and caregiver how to perform catheter care including cleansing and emptying the drainage bag. On 11/14/2024, at 10 a.m., the Director of Patient Care Services (DPCS) conducted a home visit at Patient 33’s residence. Patient 33 was observed awake, alert, oriented, and accompanied by his caregiver (CG 1). During an interview on 11/14/2024, at 10:09 a.m., CG 1 stated Patient 33 needed to have his indwelling catheter (a tube that drains urine from the bladder) changed every month. CG 1 stated she was not able to get nursing visits for Patient 33 because the HHA told her there was no Spanish speaking nurse, Patient 33 lived too far, or there was no nurse available to visit. CG 1 stated she was waiting for 2 weeks for the HHA to get back to her about the visit schedule. CG 1 stated she took Patient 33 to the clinic to have the indwelling catheter changed 3 weeks ago because the HHA never sent a nurse to change the catheter. CG 1 stated the HHA staff had never changed the catheter and was left waiting many times. CG 1 stated nursing visits were never scheduled, and she and Patient 33 never told the HHA not to come to the home. During a concurrent observation and interview on 11/14/2024, at 10:18 a.m., Patient 33’s pulled his left pant sleeve up. A tube was observed coming down the left leg, into a bag held by straps to the left calf. Clear yellow urine was collected in the bag. Patient 33 stated there was a big bag in his supply box. Patient 33 stated he knew how to empty and change the bag attached to his leg but did not know what to do with the big bag. Patient 33 stated he had situation when the leg bag started leaking because it became too full and resulted for him to wear a diaper. Patient 33 stated the leaking of his bag frustrated him. During an interview on 11/14/2024, at 10:20 a.m., CG 1 stated the problems she and Patient 33 had encountered included the bag leaking urine. CG 1 stated that was the reason they visited the clinic due to urine leaking from the bag. CG 1 stated Patient 33’s clinic staff changed the catheter and the bag 3 weeks ago. A record review of Patient 33’s record titled, “Allied Health/Nurse Visit”, dated 10/26/2024 indicated Patient 33 was seen for catheter care. The record indicated, “…walked in today with c/o (complaints of) catheter not draining…” During a concurrent interview and record review on 11/15/2024, at 11:36 a.m., the DPCS reviewed Patient 33’s visit notes titled, “Visit Notes LVN (Licensed Vocational Nurse), dated 10/17/2024, 11/6/2024, and 11/12/2024. The DPCS stated there was no documented evidence Patient 33 was taught about catheter management. What was documented was planned intervention. The DPCS stated the importance of documenting the teaching provided to Patient 33 about how to care for his catheter, was to know if the nurse was doing their work. To verify they did the teaching, so Patient 33 knows when to call, if they have any problems or anything that happens to the catheter.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation for Comprehensive Assessment of Patients was met as follows: The HHA failed to review and maintain an accurate and current medication profile (a comprehensive record of all the medications that a patient is currently taking) for one out of 10 sampled patient (Patient 18). The Licensed Vocational Nurse 1 (LVN 1) did not perform medication reconciliation and checked all prescribed medications during patient care visits. This failure placed Patient 18 at risk for medication errors and adverse reactions from the medications that could lead to hospitalization and death. (Refer to G536). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (written law) compliance with the Comprehensive Assessment of Patients Care planning was provided to the patients who were assessed to receive home health care services.

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 observation, interview and record review, the home health agency (HHA) failed to obtain a physician's order for medications for one out of 10 sampled patients (Patient 18). This failure resulted in a medication error and had the potential to result in Patient 18 having an adverse health outcomes. During a review of Patient 18's Patient Information, the Patient Information indicated, Patient 1's start of care (SOC) was 6/29/2024, with diagnosis that included type two diabetes mellitus (a long term condition in which the body has trouble controlling blood sugar and using it for energy) with foot ulcer (a break in skin or mucous membrane with loss of surface tissue). During a review of Patient 18's Home Health Certification and Plan of Care for the certification period from 8/28/2024 to 10/26/2024, Patient 18's Home Health Certification and Plan of Care indicated an order for the skilled nurse (SN) frequency of visits of four times a week for one week, for skilled nurse (SN) to visit for recertification evaluation, assess activities of daily living (ADLs) and home safety, knowledge on disease process and management, medication, and compliance. The SN was also to instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). Patient 18's Home Health Certification and Plan of Care indicated a physician's order to administer Amlodipine Besylate (medication that lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard) 5 milligrams (mg, unit of measurement) one tab daily, aspirin (is sometimes used to treat or prevent heart attacks, strokes, and chest pain) 81 mg chewable tablet daily, and Zyrtec (used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching) 10 mg one tab orally three times daily. During a joint home visit on 9/12/2024, at 2 p.m., conducted at Patient 18's residence, with license vocational nurse (LVN 1), Patient 18 was observed sitting on a couch in the living room with an open wound on the right sole of foot connected to a wound vacuum. During an observation and review of Patient 18's medications at the patient’s home with LVN 1, the following medications were not included on Patient 18’s current medication profile sheet. a. One open vial of NPH (lowers blood glucose [blood sugar] within 1 to 2 hours after administration) U-100 insulin (without open date label) to administer 35 units subcutaneously (the injection is given in the fatty tissue, just under the skin) daily. b. Glipizide (is used to treat high blood sugar levels) 10 mg two tablets twice daily. c. Jardiance (helps to manage blood sugar and prevent cardiovascular problems) 25 mg half tab orally daily. d. Lisinopril (a medicine to treat high blood pressure (hypertension) and heart failure) 20 mg one tab daily. e. Pravastatin (a medication that lowers the amount of cholesterol in your blood) 40 mg one tab daily. f. Lactulose (is used to treat constipation) 30 milliliters (ml, unit of measurement) oral twice daily. g. Olopatadine Hydrochloride 0.2 percent ophthalmic solution one drop on both eyes daily. h. Sodium Bicarbonate (an antacid used to relieve heartburn and acid indigestion) 650 mg oral twice daily. During an interview on 9/12/2024, at 2:50 p.m. with LVN 1, LVN 1 stated during the home visits, she would only ask Patient 18 if there were new medications and would never check Patient 18's actual medications during the home visits. LVN 1 also stated she was aware there was only a physician's order for amlodipine, aspirin and Zyrtec medications for Patient 18. During a further review of Patient 18's clinical record indicated no documented evidence that a physician's order was obtained for the medications mentioned that were found at Patient 18's home visit on 9/12/2024. During an interview on 9/14/2024, at 12 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated he was not able to find physician's order for the medications found at Patient 18's residence during the home visit. During a review of the agency’s undated policy and procedure titled “Plan of Care”, indicated a physician (or other authorized licensed independent practitioner) will direct the care of every home health care patient admitted for service. The attending physician (or other authorized licensed independent practitioner) will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to meet the Conditions of Participations for Skilled Professional services, as follows: 1. Ensure blood sugar was monitored and documented in the clinical record for one of 10 sampled patients (Patient 27) Refer to G710 2. Ensure the current medications were listed in the patient's medication profile for 2 of 10 sampled patients, (Patient 23 and 24). Refer to G706 3. Ensure to follow the physicians intravenous (IV- means giving medications or supplements thru the vein) orders for for 3 out of 10 sampled patients (Patients 25, 26 and 27) Refer to G710 The cumulative effect of this deficient practice resulted in the failure of the HHA to deliver statutorily mandated compliance of the Federal regulations for Skilled Professional Services to ensure provision of highest quality patient care and services.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; 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 to ensure the current medications were listed in the patient's medication profile for 3 of 10 sampled patients, (Patient 23, 24 and 27). This deficient practice had the potential to result in poor quality nursing services that can affect the health and safety of all the patients under the agency's care. 1. During a review of Patient 23’s document titled “Home Health Certification and Plan of Care” (a document used to provide a patient's plan of care and certify or recertify their care. The form is used by Home Health Care Agencies (HHAs) to ensure that patients receive the correct treatment and medical care outside of a specialized institution) indicated a start of care (SOC) date of 8/27/2024 for the certification period of 8/27/2024 to 10/25/2024 with the diagnosis of unstable angina (chest pain) and history of three times stroke (, also known as a brain attack, occurs when blood flow to the brain is disrupted, causing brain tissue damage or death). Orders for Discipline and Treatments indicated: Skilled Nurse visit s of once a week for 2 weeks to monitor Vital signs parameters: Temperature greater than 100 degrees or less than 96 degrees, pulse greater than 100 or less than 60. Respirations greater than 24 or less than 12 and blood pressure greater than 160 or less than 80. Oxygen saturation of less than 88, pain greater than level of 7. Clinician will evaluate patient/caregiver understanding of medication management including dose, route, frequency, purpose, and possible side effects. Evaluate medication effects and compliance. During a joint home visit on 9/13/2024 at 11:00 a.m., with the Director of Nursing (DON- a registered nurse (RN) who manages the nursing department of a hospital, nursing home or agency) at Patient 23’s home. Patient was observed to have left sided paralysis (a part of the body that does not move) and uses a cane for walking. Patient 23 is alert and oriented to name, person, and place. Denied pain. Wife was present during the home visit. During the medication review with the wife on 9/13/2024 at the home visit, wife stated that she oversees the patients’ medications. Wife also stated that there were medications that the patient is not taking for a long time and does not recall the patient was taking Trazodone 50 mg at bedtime for depression and Isosorbide 30 milligrams (mg- unit of measurement) daily for chest pain which is not listed in the agency’s medication list. Wife stated that the patient stopped taking a water pill because he is complaining he goes to the bathroom a lot and she does not want him to fall. Wife stated she bought over the counter medications like melatonin 20 mg for sleep aid, Vitamin D3 2000 international units (IU -unit of measurement) daily CoQ10 200mg daily and Fiber Caps 1 capsule daily for supplement. During a concurrent record review and interview with the DON on 9/13/2024 at 2:30 p.m., DON confirmed Patient 23’s non-compliance with medication during the home visit and stated it that it was not included in the nurses’ assessment and plan of care. 2. During a record review of Patient 24’s document titled “Home Health Certification and Plan of Care” indicated an SOC date of 9/5/2024 for the certification period of 9/5/2024- 11/3/2024 with the diagnosis of acute respiratory failure (a serious condition that makes it difficult to breathe on your own) with hypoxia (a dangerous condition that occurs when the body doesn't have enough oxygen in its tissues). Skilled nursing (SN) visits was once a week for one week and physical therapy (PT- a type of treatment that helps people improve their movement and physical function) for once a week for one week, twice a week for one week and once a week for one week. Clinician to evaluate patient/caregiver for understanding of medication management including dose, route, frequency, purpose, and possible side effects. Evaluate medication effects and compliance. Clinician to assess patient's lung sounds. respiratory rate, sputum production/color, 0xygen saturation (percentage level of oxygen in the blood) per random pulse oximeter. Instruct patient/caregiver to notify MD/Clinician for fever, increased sputum production, green/yellow sputum, increased difficulty breathing, weakness, sore throat. or any signs and symptoms of respiratory distress. Instruct and demonstrate adaptive breathing techniques such as deep breathing. abdominal breathing, and coughing techniques. Teach patient energy conserving methods such as frequent meals and rest periods. Educate patient/caregiver importance of exercise to tolerance and to avoid fatigue. During a joint home visit on 9/12/2024 at 11:30 a.m., with the DON at Patient 24’s home. Observed that Patient 24 was alert and oriented to name, place, and person with periods of forgetfulness. Patient’s wife and son were both present during the home visit. Patient 24 has oxygen via nasal cannula at 2 liters per minute (lpm- unit of measurement) for difficulty breathing. Patients’ son stated that his father is a mouth breather and was requesting a mask for his oxygen which was not provided by the agency. During a review of Patient 24’s home medication list during the home visit at the same date and time, revealed that Diclofenac Sodium 1% cream, give 4 grams (gm- unit of measurement) twice as needed for low back pain and Flomax 0.4 mg 1 capsule daily for prostate. Oxygen inhalation via nasal cannula (a tube used to inhale oxygen for breathing) 2 lpm as needed for difficulty breathing. On concurrent interview, Patient 24 stated that the bottle of Flomax indicated 2 capsules and only takes one capsule only. Both medications and oxygen inhalation were not listed on the agency’s medication list but was ordered by Patient 24’s physician. During a concurrent interview and record review with the DON and Chief Executive Officer (CEO- owner of the agency) on 9/13/2024 at 2:47 p.m., DON confirmed that it was not included during the nurse’s assessment and medication list upon admission and therefore was not included in the plan of care. CEO stated that they have a meeting with contractor weekly every Thursday and Kaiser will generally give preauthorized home visits and usually takes time for them to reply to increase or decrease the home visits. Both DON and CEO agreed there should be a system that both the HHA and the contractor can agree to provide the service faster. 3. During a record review of Patient 27’s document titled “Home Health Certification and Plan of Care” with the DON on 9/13/2024 at 3:50 p.m., indicated an SOC date of 3/31/2024 with a certification period reviewed on 7/29/2024 to 9/29/2024 with the diagnosis of sepsis and renal and perinephric abscess (severe complications of urinary tract infections) and type 2 diabetes (a chronic condition that occurs when the body is unable to use insulin properly, resulting in high blood sugar levels). Orders for Discipline and Treatments: Instruct patient and caregiver to monitor blood sugar two times per day and as needed for diabetic symptoms and report blood sugar levels below 60 or above 300 to physician. Teach patient and caregiver proper glucometer testing and recording. Medications/Injections: Medication management: Clinician to evaluate patient /caregiver for understanding of medication management including dose, route, frequency, purpose, and possible side effects. Evaluate medication effects and compliance. During a telephone interview on 9/13/2024 at 9:30 a.m., with Patient 27’s niece, the niece stated that she made multiple complaints about this HHA for inconsistency with the nurses visiting her uncle and often there was no visits on the weekend. Per niece, stated she wanted her uncle and aunt to be familiar with the same nurse as much as possible. Per niece also mentioned that they used to visit the patient daily for IV antibiotic infusion and now it is once a week only for PICC line care. Per niece, the nurses do not check the patients’ blood sugar or check the patients’ medications. During the record review of Patient 27’s clinical record with the DON on 9/13/2024 at 3:50 p.m., the DON stated the frequency of home visits is once a week for PICC line care. Patient 27’s clinical record also revealed that the visiting nurse does not record the patients’ blood sugar in their visit notes. Visit notes revealed that there were missed home visits on 9/3/2024, 9/5/2024, 9/6/2024, 9/7/2024 and 9/8/2024. The last home visit note was 9/9 and no home visits followed. DON also confirmed that as of 8/31/2024 the visit nurse only documented “IV antibiotic connected as ordered”. There was no documentation from the visiting nurse that the patient can administer the IV on his own. There was no documented evidence of Vancomycin 600 mg IV listed on the medication profile. During a phone interview on 9/13/2024 at 12:00 noon with SLACAH, the SLACAH stated that frequency of visits was supposed to be daily for IV starting 8/13/2024 to 12/10/2024. Per SLACAH, stated that this is not a new patient for this agency and is already familiar with this patient. SLACAH also mentioned that the visiting nurse should show documentation on their visit notes if the patient is already skilled and knowledgeable to administer his own IV, therefore they can inform the physician to decrease the home visits. Per SLACAH there was only a change in the Vancomycin dose to 600 mg IV every 24 hours over 60 minutes starting 9/4/2024. There were no changes in the frequency of home visits ordered. A review of the HHA’s document titled “Ongoing Assessments” revised 4/2020, indicated that during each home visit, the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. Based on each reassessment, the plan of care-including problems, needs, goals, and outcomes-will be reviewed and revised by the clinician. Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician (or other authorized licensed independent practitioner) for signature(s). The physician will be notified to verify any changes in medications, including over-the-counter medications which might interact or be duplicative with other patient medications, and care, treatment, or services that require physician approval. A review of the HHA’s document titled “Medication Profile” revised 4/2020, indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. For accuracy and to completely reconcile medications across the continuum of care, the admitting organization will obtain and document a complete list of the patient's current medications upon the patient's entry to the organization. A comparison of the medications ordered for the patient while under the organization's care will be made to those on the list. The admitting nurse will initiate a medication profile to document the current medication regimen, including name, strength, dose, route, frequency, date and time of administration and a diagnosis, condition, or indication for use for each medication ordered. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, and when care is resumed after a patient has been placed on hold. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy omissions and unclear information. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to: 1. Ensure Patient 27’s blood sugar was monitored and documented in the clinical record for one of 10 sampled patients (Patient 27) 2. Ensure to follow the physician’s intravenous (IV- means giving medications or supplements thru the vein) order for 3 of 10 sampled patients (Patients 25, 26 and 27) This deficient practice had the potential to result in poor quality nursing services that can affect the health and safety of all the patients under the agency's care. 1. During a record review of Patient 25’s document titled “Home Health Certification and Plan of Care” the plan of care indicated an SOC date of 8/31/2024 for the certification period reviewed on 8/31/2024 to 10/29/2024 with the diagnosis of abscess of the liver (a pus-filled mass in the liver that can develop from injury to the liver or from an intra-abdominal infection). Patient 25 has a PICC line (Peripherally Inserted Central Catheter- a type of long catheter that is inserted through a peripheral vein, often in the arm used to give long term chemotherapy or antibiotics). During a record review of Patient 25’s clinical record on 9/13/2024 at 3:27 p.m, with the DON, the DON stated that the frequency of home visits for this certification period is daily for five days then once a week for three weeks. The DON stated that the change in frequency is in the contractor’s portal but he had not checked it yet. The DON also confirmed that Patient 25’s clinical record revealed that the visiting nurse submitted only one note dated 9/1/2024 and notes for 9/2/2024, 9/3/2024, 9/4/2024, 9/5/2024 and 9/6/2024 was not seen in the patients clinical record. During a telephone interview and concurrent record review on 9/14/2024 at 10:53 a.m., with SLACAH, stated that the initial order was daily home visits to give intravenous (IV) antibiotic Rocephin 1 gram every 24 hours via PICC line from 8/31/2024 till 9/13/2024. SLACAH also mentioned that there were no other changes in visit frequency or changes in medication orders for Patient 25. 2. During a record review of Patient 26’s document titled “Home Health Certification and Plan of Care” indicated an SOC date of 8/16/2024 with a certification period of 8/16/2024 to 10/14/2024 with the diagnosis of cellulitis (a bacterial infection that affects the deeper layers of the skin and surrounding tissue. It can cause pain, swelling, redness, and inflammation in the infected area. Cellulitis can be serious if left untreated and can spread quickly throughout the body) of the right upper limb and sepsis (a life-threatening medical emergency that occurs when the body's immune system overreacts to an infection or injury. Orders for Discipline and Treatments included Infection/Immunological: the nurse will administer the IV as prescribed IV antibiotic ( Unasyn and Vancomycin) daily up to 9/5/2024, weekly blood draw for BUN (measures the amount of urea nitrogen in your blood, which can indicate how well your kidneys are functioning)/creatinine(a waste product created when your muscles break down to produce energy), CBC(a blood test that measures the levels of different components in your blood), ALT (measures the level of alanine transaminase (ALT), an enzyme found primarily in the liver, in your blood), weekly midline dressing change. During a record review on Patient 26’s clinical record on 9/13/2024 with the DON and CEO at 3:42 p.m., the DON stated that the visit frequency was daily for IV antibiotic till 9/5/2024 then once a week for five weeks. The DON and CEO also confirmed that Patient 26 went to the hospital for debridement on 8/27/2024. There was a missed visit on 8/28/2024 when Patient 26 went to the hospital and on 9/4/2024 when patient had Covid-19 and no other visit notes followed. During a telephone interview with SLACAH on 9/14/2024 at 11:00 a.m., The SLACAH stated that the order was Unasyn1 gram IV daily and Vancomycin1.25 gram IV every 12 hours for four weeks. Per SLACAH, Patient 26 went to the hospital for abscess debridement (removal of infected tissue) on 8/27/2024 and was sent home on 8/29/2024. Per SLACAH, the HHA should still resume the home visits for Patient 26 and there was no visit frequency change for this patient or changes in medications as of 8/29/2024 because the agency needs to call the patients physician to resume care. Per SLACAH, the agency needs to call the contractor’s phone number and ask the appointment messaging center to transfer to the “Physician’s Line” to speak to the patient’s physician for urgent orders. 3. During a record review of Patient 27’s document titled “Home Health Certification and Plan of Care” with the DON on 9/13/2024 at 3:50 p.m., indicated an SOC date of 3/31/2024 with a certification period reviewed on 7/29/2024 to 9/29/2024 with the diagnosis of sepsis and renal and perinephric abscess (severe complications of urinary tract infections) and type 2 diabetes (a chronic condition that occurs when the body is unable to use insulin properly, resulting in high blood sugar levels). Orders for Discipline and Treatments included to Instruct patient and caregiver to monitor blood sugar two times per day and as needed for diabetic symptoms and report blood sugar levels below 60 or above 300 to physician. Teach patient and caregiver proper glucometer testing and recording. Medications/Injections: Medication management: Clinician to evaluate patient /caregiver for understanding of medication management including dose, route, frequency, purpose and possible side effects. Evaluate medication effects and compliance. Infection/Immunological: Inspect wounds and sites of Invasive devices daily, paying particular attention to PICC line, drains and tubes. Document signs of local Inflammation and infection and changes in character wound drainage, sputum, or urine. - Monitor for signs of deterioration of the condition or failure to improve with therapy. Deterioration of a clinical condition or failure to improve with therapy may reflect inappropriate or inadequate antibiotic therapy or overgrowth of resistant or opportunistic organisms. - Monitor laboratory values. - Administer IV Antibiotic as ordered. During a telephone interview on 9/13/2024 at 9:30 a.m., with Patient 27’s niece, the niece stated that she made multiple complaints about this HHA for inconsistency with the nurses visiting her uncle and often, there was no visits on the weekend. Per niece, she called over the weekend and no one will answer and she was afraid no one will give the IV antibiotic. Per niece, she wanted her uncle and aunt to be familiar with the same nurse as much as possible. Niece also mentioned that they used to visit the patient daily for IV antibiotic infusion and now it is once a week only for PICC line care. Per niece, the nurses do not check the patients’ blood sugar or check the patients’ medications. During the record review of Patient 27’s clinical record with the DON on 9/13/2024 at 3:50 p.m., the DON stated the frequency of home visits is once a week for PICC line care. Patient 27’s clinical record also revealed that the visiting nurse does not record the patients’ blood sugar in their visit notes. Visit notes revealed that there were missed home visits on 9/3/2024, 9/5/2024, 9/6/2024, 9/7/2024 and 9/8/2024. The last home visit note was 9/9 and no home visits followed. DON also confirmed that as of 8/31/2024 the visit nurse only documented “IV antibiotic connected as ordered”. There was no documentation from the visiting nurse that the patient can administer the IV on his own. During a phone interview on 9/13/2024 at 12:00 noon with SLACAH, the SLACAH stated that frequency of visits was supposed to be daily for IV starting 8/13/2024 to 12/10/2024. Per SLACAH, stated that this is not a new patient for this agency and is already familiar with this patient. SLACAH also mentioned that the visiting nurse should show documentation on their visit notes if the patient is already skilled and knowledgeable to administer his own IV, therefore they can inform the physician to decrease the home visits. Per SLACAH there was only a change in the Vancomycin dose to 600 mg every 24 hours over 60 minutes starting 9/4/2024. There were no changes in the frequency of home visits ordered. A review of the HHA’s document titled “Care Coordination” revised 4/2020 indicated to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member of the interdisciplinary group, will be appropriate to the needs and abilities of the patient, and will be relevant to the care provided. The clinicians will be responsible for facilitating communications about changes in the patient's status among the assigned personnel. Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patient's clinical records. Care coordination will include, but not be limited to: Integrate orders from all physicians involved in the plan of care so that all services and interventions are coordinated. Organization personnel will communicate changes in a timely manner via telephone, one to-one meetings, case conferences and home visits. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. Written evidence of care coordination may be found in the plan of care, case conference summary forms, or clinical notes in the patient's clinical record. A review of the HHA’s document titled “Care Planning Process” revised 4/2020 indicated 3. Based on the assessment and conclusions, the plan of care will include, but not be limited to: A. Patient specific interventions and education B. All patient care orders from all physicians involved in the plan of care, including verbal orders C. Identified patient problems and needs, including functional limitations, activities permitted, nutritional requirements D. Reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care E. Specific services and treatments to be provided F. Actions to be taken to meet the patient goals G. Type, including identifying the responsible discipline(s), frequency, and duration of above actions H. Equipment and supplies I. Information related to any advanced directives J. All pertinent diagnoses K. The patient's mental, psychosocial, and cognitive status L. All medications M. Safety measures to protect against injury. 0. Patient and caregiver education and training to facilitate timely discharge

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey. Representing the Department of Public Health: Surveyor ID # 43979 -RN HFEN Surveyor ID # 43929 -RN HFEN Surveyor ID# 19096 - RN HFEN Unduplicated admissions: 783 Census: 147 Sample Size: 17 Home Visits: 5 Closed Record review: 2 The following Condition of Participation were not met: 484.50 Patient rights. 484.60 Care planning, coordination of services, and quality of care. 484.110 Clinical records.

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Patient Rights was met as follows: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Patient Rights was met as follows: 1. The Home Health Agency (HHA) failed to ensure one of 17 sampled patients (Patient 16) was informed of all aspects of the planned care and services, and the way the care and services will be delivered by the HHA. This failure resulted in the violation of Patient 16's rights to be informed of the care and treatment furnished by the HHA as identified in the plan of care (POC). Refer to G434. 2. The Home Health Agency (HHA) failed to ensure seven (7) of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, and Patient 16) clinical records were kept confidential and accessed only by authorized and qualified personnel of the HHA. This failure resulted for these clinical records being accessed by unauthorized and unqualified personnel and were not safeguarded to protect the privacy of Protected Health Information (PHI) for these patients. Refer to G438. 3. The Home Health Agency (HHA) failed to ensure twelve of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, Patient 11, Patient 12, Patient 13, Patient 15, Patient 16, and Patient 17) received information regarding the State toll free home health contact information, its hours of operation, and its purpose. This failure resulted in the violation of patient’s rights for not being informed of the toll-free hotline number to lodge their concerns of the care and services provided by the HHA. Refer to G444. 4. The Home Health Agency (HHA) failed to ensure twelve of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, Patient 11, Patient 12, Patient 13, Patient 15, Patient 16, and Patient 17) received information on Federal and State funded entities available in the areas they reside in. This failure had the potential to result for these patients to lack knowledge of the Federally and State funded entities and the right to choose services from these entities that are available to them. Refer to G446. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Patient Rights to ensure highest quality health care is provided to patients assessed to receive home health services.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure one of 17 sampled patients (Patient 16) was informed of all aspects of the planned care and services, and the way the care and services will be delivered by the HHA. This failure resulted in the violation of Patient 16's rights to be informed of the care and treatment furnished by the HHA as identified in the plan of care (POC). A review of Patient 16’s record titled, “Personal Information”, indicated a start of care on 3/28/2024, with a primary diagnosis of malignant neoplasm of unspecified main bronchus (lung cancer). A record review of Patient 16’s record titled, “Referral Priority”, dated 2/12/2024, indicated Patient 16’s doctor had referred him to home health for Physical Therapy. The record indicated, “…is a 81 year old male with lung cancer, fall risk, and gait abnormality, needs assisted devices, has been difficulty to get out of bed since starting chemotherapy, needs PT (Physical Therapy)”. During an interview on 4/10/2024 at 4:31 a.m., Patient 16’s caregiver (CG 4) stated he was referred to HHA services a few months ago and did not know why the visits started two weeks ago. CG 4 stated Patient 16 was referred to HHA to receive Physical Therapy (PT) to help him because he was getting weak from chemotherapy (cancer treatment). CG 4 stated was told on the first HHA visit, that Patient 16 could not get PT because he was too weak. CG 4 stated HHA staff verbally instructed Patient 16 how to do physical therapy and referred them to YouTube videos for review. CG4 stated Licensed Vocational Nurse 4 (LVN 4) informed CG 4 and Patient 16 was only authorized for a few visits and Patient 16 would be transferred to another company. CG4 stated she was instructed to call the insurance company to approve more visits. CG 4 stated she was not told the reason for transfer, when the transfer would occur, and the information of the transfer. CG 4 stated Patient 16 did not want Hospice Care. During an interview on 4/11/2024, at 1:25 p.m., LVN 4 stated he had seen Patient 16 twice: on 4/3/2024 and 4/20/2024. LVN 4 stated his primary job was at a hospice agency (HA). LVN 4 stated the plan was to transfer Patient 16 to another agency if he qualified for hospice care and Patient 16 agreed. When asked about PT services, LVN 4 stated, “I don’t know about that. Is he requesting it? I gave him training on passive range of motion exercises.” During an interview on 4/11/2024, at 2 p.m., the Chief Executive Officer (CEO) stated the case manager (Administrator-ADM) was managing the care of Patient 16. The CEO stated Patient 16 was discharged to hospice care. When the CEO was informed Patient 16 was still active in the Electronic Medical Record (EMR), the CEO stated the last visit was done already and Patient 16 should be discharged. When asked where Patient 16 was discharged to, the CEO stated, “hospice care”. During an interview on 4/11/2024, at 2:11 p.m., the Administrator (ADM) stated she was managing the care of Patient 16. The ADM stated she did not work at the HHA, and she was the administrator of the Hospice Agency (HA). The ADM stated Patient 16’s insurance had initially referred him to the HA on 3/26/2024 or 3/27/2024. The ADM stated she referred Patient 16 to the HHA because the family was not ready for hospice care. During a concurrent interview and record review on 4/11/2024, at 2:15 p.m., the CEO reviewed Patient 16’s document titled, “Authorization for Medical Services”, dated 3/27/2024. The CEO stated the authorization could be used for HHA or Hospice services. The CEO stated the document indicated Patient 16 was authorized for a total of 3 visits. Patient 16 had received his third visit on 4/10/2024. During an interview on 4/12/2024, at 2:18 p.m., the ADM stated Patient 16 did not receive PT services based on the recommendation of the nurse. When asked why there was a delay in HHA services, based on Patient 16’s document titled, “Authorization for Medical Services”, dated 2/13/2024, the ADM stated, “Those questions should be answered by the insurance company.” During an interview on 4/11/2024, at 2:24 p.m., the CEO stated the plan for Patient 16 was to transfer to hospice care, when the patient's health status declined further. The CEO stated that was the agreement with CG 4. During an interview on 4/11/2024, at 2:30 p.m., the Director of Patient Care Services (DPCS) stated there was no documentation in Patient 16’s medical record to indicate Patient 16 and CG4 were informed and involved in the transfer or discharge plans. The DPCS stated the coordination of care should have been documented in the progress/communication log in the EMR. The importance of documentation was to make sure proper care was done. The DPCS stated if it was not documented, it did not happen. During an interview on 4/12/2024, at 9:55 a.m., Registered Nurse 2 (RN 2) stated she was the nurse who did the initial visit to Patient 16’s home. RN 2 stated Patient 16 was referred to the HHA for PT and also possible hospice care. RN 2 stated Patient 16 was too weak from chemotherapy and could barely stand up for PT. RN 2 stated it was the scope of practice for the Registered Nurse to assess the patient and determine if patient is ready for PT or not. RN 2 stated the doctor was not informed of Patient 16 not getting the PT evaluation. RN 2 stated she was not aware to discharge or transfer Patient 16 to hospice care. RN 2 stated the CG4, and Patient 16 did not want hospice care. RN 2 stated, “no, we are not transferring patient to hospice.” During an interview on 4/12/2024, at 11:45 a.m., Patient 16’s insurance representative (INS) stated he was authorized for 1 RN visit, 6 LVN visits, 1 PT evaluation, and 5 PT home health visits. The INS stated Patient 16 was authorized for HHA services on 2/21/2024 and did not know why Patient 16 did not begin the services. A record review of Patient 16’s record titled, “Communication Log”, dated 4/11/2024, indicated, “…family are not interested in anymore visits”. During an interview on 4/12/2024, at 1:30 p.m., CG 4 stated she informed the HHA she did not want any more services because she did not trust the HHA.

Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure seven (7) of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, and Patient 16) clinical records were kept confidential and accessed only by authorized and qualified personnel of the HHA. This failure resulted for these clinical records being accessed by unauthorized and unqualified personnel and were not safeguarded to protect the privacy of protected health information (PHI) for these patients. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 2’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 2’s Electronic Medical Record (EMR) on 4/5/2024. During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a review of Patient 3’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient ’s Electronic Medical Record (EMR) on 4/10/2024. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a review of Patient 4’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 4’s Electronic Medical Record (EMR) on 4/9/2024. During a review of Patient 6’s medical record form titled “Personal Information” indicated a start of care date of 3/20/2024 with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 6’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 6’s Electronic Medical Record (EMR) on 4/3/2024 and 4/8/2024. During a review of Patient 7’s medical record form titled “Personal Information” indicated a start of care date of 4/4/2024 with a primary diagnosis of osteoporosis with current path fracture (broken bone) right femur. During a review of Patient 7’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 7’s Electronic Medical Record (EMR) on 4/9/2024 and 4/10/2024. During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of atherosclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). During a review of Patient 9’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 9’s Electronic Medical Record (EMR) on 4/9/2024. A review of Patient 16’s record titled, “Personal Information”, indicated a start of care on 3/28/2024, with a primary diagnosis of Malignant neoplasm of unspecified main bronchus (lung cancer). During a concurrent interview and record review on 4/12/2024, at 9:45 a.m., the DPCS reviewed Patient 16’s record titled, “Audit Log”, dated 3/28/2024 to 4/12/2024. The record indicated QA 1 had made modifications to the document titled OASIS-SOC (a document that describes the nursing assessment done for admission into the HHA) from 4/8/2024 to 4/10/2024. The modifications included changes to the narrative (care coordination/narrative) such as changing the previous value of “to refer to physical therapy, refer to occupational therapy, refer to MSW” to “refer to Physical Therapy: N/A (N/A not applicable), Refer to Occupational Therapy: N/A, Refer to MSW: N/A. The DPCS stated QA 1 was not available for an interview because she was out in the Philippines. During an interview on 4/12/2024 at 9:55 a.m. with the Director of Patient Care Services (DPCS), DPCS stated Quality Assurance 1 (QA1) was granted access to HHAs patients EMR and worked remotely from Manila, Philippines. DPCS stated QA1 is responsible for reviewing assigned patients EMRs and send a written report if there are any discrepancies. DPCS stated QA1 was not supposed to document in patients EMR because she was not physically seeing the patients. During an interview on 4/12/2024 at 2:55 p.m. with the Director of Patient Care Services (DPCS), DPCS stated the HHA did not have employee records/files for both contracted QA1 and QA2 who worked remotely out of the country and had clinical access to patients EMRs. DPCS stated contracted employee files were needed to ensure the personnel were competent and had their criminal background checked. DPCS stated both contracted QA were not licensed in California, and he did not have proof that they were licensed nurses. During an interview on 4/12/2024, at 10:35 a.m., the Chief Executive Officer (CEO) stated the HHA outsourced to a 3rd party company that used staff from the Philippines to do the quality assurance, because it was cheaper. The CEO stated, “Do you know how expensive QA is here in the USA? Medicare doesn’t pay enough. That is a legitimate business. They are licensed, what is the violation here?” A review of facility’s policy and procedure titled “Entries into the Clinical Record” revised 4/2020, indicated “Home health personnel providing direct patient care and supervision functions have authority to make entries into the clinical record. Amendments, corrections or late entries within an electronic health record must: distinctly identify any amendment, correction, or late entry.”

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure twelve of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, Patient 11, Patient 12, Patient 13, Patient 15, Patient 16, and Patient 17) received information regarding the State toll free home health contact information, its hours of operation, and its purpose. This failure resulted in the violation of patient’s rights for not being informed of the toll-free hotline number to lodge their concerns of the care and services provided by the HHA. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a joint home visit on 4/10/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) of Patient 4’s retirement center, LVN1 was unable to locate the State toll-free home health hotline phone number. LVN1 stated, “I don’t know if they have it or not, the admitting nurse had to explain it.” During a review of Patient 6’s medical record form titled “Personal Information” indicated a start of care date of 3/20/2024 with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 7’s medical record form titled “Personal Information” indicated a start of care date of 4/4/2024 with a primary diagnosis of osteopososis with current path fracture (broken bone) right femur. During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of atherosclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). A review of Patient 11’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). During a concurrent observation and interview at the home visit on 4/10/2024, at 11:40 a.m., Patient 11’s caregiver (CG 3) reviewed the folder and booklet the HHA provided. CG 3 stated he did not know how to contact the State department to voice concerns with care and stated, “How do I contact you guys?”. A review of Patient 12’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). A review of Patient 13’s record titled, “Personal Information”, indicated a start of care on 12/20/2023, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). A review of Patient 15’s record titled, “Personal Information”, indicated a start of care on 2/28/2023, with a primary diagnosis of Dementia (impaired ability to make decisions of everyday activities). During an interview at the home visit on 4/10/2024, at 10:35 a.m., Patient 15’s caregiver (CG 2) stated she did not know how to contact the State department if she had any concerns about the care the HHA was offering. A review of Patient 16’s record titled, “Personal Information”, indicated a start of care on 3/28/2024, with a primary diagnosis of Malignant neoplasm of unspecified main bronchus (lung cancer). A review of Patient 17’s record titled, “Personal Information”, indicated a start of care on 7/13/2024, with a primary diagnosis of hypertensive heart disease with heart failure (high blood pressure, heart not pumping effectively). During a concurrent interview and record review on 4/12/2024 at 10:50 a.m., with the Director of Patient Care Services (DPCS) stated the hours of operation, and the purpose for the State complaint toll free number was not listed in the admission packet. DPCS stated it was important for patients to be provided with all the information needed to be able to make a complaint. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The right to voice a complaint or concern regarding care or services. The availability of other sources to receive questions and complaints and assist in resolution. The availability of the applicable toll-free…. hotline and other sources to receive questions or complaints and assists in resolution including implementation of the advance directive requirements.” A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “If eligibility criteria are met, the patient and family caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: nature and goals of care and services. Available community resources. Other organization personnel involved in care.”

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure twelve of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, Patient 11, Patient 12, Patient 13, Patient 15, Patient 16, and Patient 17) received information on Federal and State funded entities available in the areas they reside in. This failure had the potential to result for these patients to lack knowledge of the Federally and State funded entities and the right to choose services from these entities that are available to them. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a joint home visit on 4/10/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) of Patient 4’s retirement center, LVN1 was unable to locate contact information for the Federally and State funded entities. LVN1 stated “I don’t know if they need to have those or not”. LVN1 stated patient should be provided with the contact information to be able to have those resources available to them. During a review of Patient 6’s medical record form titled “Personal Information” indicated a start of care date of 3/20/2024 with a primary diagnosis of hypertensive (high blood pressure) heart diseas without heart failure. During a review of Patient 7’s medical record form titled “Personal Information” indicated a start of care date of 4/4/2024 with a primary diagnosis of osteopososis with current path fracture (broken bone) right femur. During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of atherosclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). A review of Patient 11’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). A review of Patient 12’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). A review of Patient 13’s record titled, “Personal Information”, indicated a start of care on 12/20/2023, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). A review of Patient 15’s record titled, “Personal Information”, indicated a start of care on 2/28/2023, with a primary diagnosis of Dementia (impaired ability to make decisions of every day activities). A review of Patient 16’s record titled, “Personal Information”, indicated a start of care on 3/28/2024, with a primary diagnosis of Malignant neoplasm of unspecified main bronchus (lung cancer). A review of Patient 17’s record titled, “Personal Information”, indicated a start of care on 7/13/2024, with a primary diagnosis of hypertensive heart disease with heart failure (high blood pressure, heart not pumping effectively). During a concurrent interview and record review on 4/12/2024 at 10:50 a.m. with the Director of Patient Care Services (DPCS) of HHA’s patient admission packet, DPCS stated the federally and state funded entities were listed but not their contact information. DPCS stated it was important for patients to be provided with the entities contact information to have the resources available to them. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The names, addresses, and telephone numbers of the following Federally funded and State-funded entities that serve the area where the patient resides: 1. Agency an Aging 2. Center for Independent Living 3. Protection and Advocacy Agency 4. Aging and Disability Resource Center 5. Quality Improvement Organization.” A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “If eligibility criteria are met, the patient and family caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: nature and goals of care and services. Available community resources. Other organization personnel involved in care.”

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 interview and record review the Home Health Agency (HHA) failed to review and document all the current medications and treatments for four of 17 sampled patients (Patient 3, Patient 4, Patient 11, and Patient 15). This failure placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a joint home visit on 4/10/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) to Patient 3’s retirement center, home. LVN1 singed in at Patient 3’s retirement center and headed to Patient 3’s room #17. LVN1 stated Patient 3 was not in room and will ask retirment center office on his whereabouts. Patient 3’s retirement center Medication Technician (MT) stated the retirment center was an “in and out” facility. MT stated Patient 3 was awake, alert and ambulatory. Retirement center Office Manager (OM) stated Patient 3 left the retirement center by himself and stated he was going to the Department of Motor and Vehicles. OM stated Patient 3 is independent. LVN1 did not ask the retirement staff to view Patient 3 medications or his medication list or if there were any changes to his medication. During a concurrent interview and record review on 4/12/2024 at 11:16 a.m. with the Director of Patient Care Services (DPCS) of Patient 3’s Electronic Medical Record (EMR), DPCS stated the HHA did not have Patient 3’s retirement center service agreement to be able to compare their medication list to the HHAs medication profile. DPCS stated if the retirement center is administering patients their medications, the skilled nurse is supposed to request to see the patients’ physical medications to be able to compare them with the HHA medication profile. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a review of Patient 4’s HHA’s medical record form titled “Medication Profile” indicated Patient 4 was taking Aripiprazole (antipsychotic medication), Carvedilol (high blood pressure medication) 3.125 mg (milligrams) daily, Divalproex (seizure medication) 250 mg daily, Losartan (high blood pressure medication), and Mirtazapine (anti depression medication). During a review of Patient 4’s retirement center untitled medication list indicated Patient 4 was takinng Aripiprazole, Carvedilol 3.125 mg twice daily, Divalproex 250 mg twice daily, Losartan, Mirtazapine, Ondasteron (anti nausea/vomiting medication), Zolpidem (sleep aid medication), Acetaminophen (pain medication), Docusate sodium (stool softerner medication), and Loratadine (allergy medication). During a joint home visit on 4/10/2024 at 9:20 a.m. with LVN1 to Patient 4’s retirement center, home. LVN1 singed in at Patient 4’s retirement center and headed to Patient 4’s room #14. LVN1 stated Patient 4 was not in room and will ask retirment center office on her whereabouts. MT stated she saw Patient 4 in the front patio. Patient 4 noted ambulating with a slow steady gait outside of retirement center. Patient 4 ambulated with a slow steady gait to her room. LVN1 did not ask the retirement staff to view Patient 4 medications or her medication list or if there were any changes to her medication. During an interview on 4/10/2024 at 9:50 a.m. with MT, MT stated she provides medications to all the patients at the retirement center, including Patient 3 and Patietn 4. MT stated she did not have the HHAs medication lists, or plan of care for Patient 3 or Patient 4’s or any information from the HHA. MT stated, “the home health probably gave the patients their med list and their plan.” During a phone interview on 4/10/2024 at 11:46 a.m. with LVN1, LVN1 stated he reconciles patient medication every two weeks. LVN1 stated medication reconcilaition is importatnt to keep track of patients current medications and to update the HHA medication profile. During a concurrent interview and record review on 4/12/2024 at 11:40 a.m. with the DPCS of Patient 4’s EMR, DPCS stated Patient 4’s retirement facility and HHA’s medication sheets were not the same. DPCS stated the HHA needed to coordinate with Patient 4’s retirement facility for the patients wellness. A review of Patient 11’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). During a concurrent observation, interview, and record review, at the home visit on 4/10/24 at 11:25 a.m., Licensed Vocational Nurse 5 (LVN 5) reviewed Patient 11’s medication using document titled, “Medication Profile”, dated 3/15/2024. The record indicated “Myrbetriq (relaxes the muscles of the bladder) 25 mg (mg-unit of measurement). The medication label observed at the home indicated 50 mg. The following medications were observed at the home and were not included on the profile as stated by LVN 5: Diclofenac 1 % gel cream Betamethasone 0.05% cream Fish oil 1400 mg Nystatin ointment 100,000 gram. Vitamin C 500 mg Vitamin D 2 1.25 mg Alendronate 70 mg tab Immodium 2 mg LVN 5 stated anytime there is a medication change, she usually text messaged the nurse at the office to notify of the change. A review of Patient 15’s record titled, “Personal Information”, indicated a start of care on 2/28/2023, with a primary diagnosis of Dementia (impaired ability to make decisions of every day activities). During a concurrent observation, interview, and record review, at the home visit on 4/10/24 at 10:15 a.m., Licensed Vocational Nurse 3 (LVN 3) reviewed Patient 15’s medication using document titled, “Medication Profile”, dated 3/6/2023. The record indicated “Calcium (a supplement) 600 mg with Vitamin D 3. The medication label observed at the home indicated 500 mg. The following medication was observed at the home and were not included on the profile as stated by LVN 3: Docusate Sodium (stool softener) 100 mg. “Advair Diskus” (for shortness of breath or asthma) was listed in the profile, but not at the patient’s home. During a concurrent observation, interview, and record review, at the home visit on 4/10/24 at 10:30 a.m., LVN 3 reviewed Patient 15’s medication using document titled, “Medication Profile”, dated 3/6/2023. LVN 3 stated Albuterol Sulfate 0.083%, expiration date was 4/7/2023. Patient 15’s caregiver (CG 2) stated the last time she had taken the medication was 1 year ago. CG 2 showed LVN 2 4 boxes of medication of Albuterol Sulfate, and LVN 2 stated all four boxes had expired on 4/7/2023. During an interview on 4/10/2024, at 10:42 a.m., LVN 2 stated medications are reviewed every visit. LVN 2 stated the importance of updating the medication profile, is so patient is aware of the medications she is supposed to take. During an interview on 4/12/2024 at 10:50 a.m. with the Director of Patient Care Services (DPCS), DPCS stated when a patient is admitted, it is the responsibility of the admitting nurse to reconcile all the patients’ medications. DPCS stated medication reconciliation occurs at every nursing visit to ensure the current medications are listed on their medication profile. DPCS stated medication reconciliation is needed to ensure the patients response to the effectiveness of the medications are noted. DPCS stated when patients’ medications are not reconciled, the HHA is unable to assist patients sustain their health and maintenance of their medications. A review of facility’s policy and procedure titled “Medication Profile” revised 4/2020, indicated “For accuracy and to completely reconcile medications across the continuum of care, the admitting organization will obtain and document a complete list of the patient’s current medication s upon the patient’s entry to the organization. A comparison of the medications ordered for the patient while under the organization care will be made to those on the list. During subsequent home visits, the medication profile will because as a care planning tool and teaching guide to ensure that the patient and family caregiver, as well as other clinicians, understand the medication regimen. The medication profile and other relevant data will be available to all clinicians providing care.” A review of facility’s policy and procedure titled “Ongoing Assessment” revised 4/2020, indicated “Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: blood pressure, pulse, respiration, temperature. Functional status. Compliance with treatment and/or medications.”

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the HHA failed to ensure a discharge comprehensive assessment including OASIS was completed for one of 17 sample patients (Patient 8) within 2 days of patient's discharge. This deficient practice had the potential to not informing other disciplines regarding patient progress and meeting the care plan goals. .. During a review of Patient 8’s electronic discharge record form title, “Personal Information”, indicated a start of care date of 3/20/2024, with an End of Care Date of 3/28/2024, with primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) During a review of Patient 8's electronic discharged medical record, there was no discharge OASIS or Discharge summary. During a concurrent record review and interview with the DPCS in the HHA’s conference room on 4/12/2024, at 11:40 a.m., stated the nurse should have completed her notes.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: The Home Health Agency (HHA) failed to ensure the individualized Plans of Care (POC) were implemented for five of 17 sampled patients (Patient 1, Patient 2, Patient 4, Patient 6, and Patient 11). This failure resulted in the physician not being aware of the services not being provided to the patients in accordance with the POC. Refer to G572. The Home Health Agency (HHA) failed to include the disciplines and the visit frequencies in the plan of care (POC) for one of 17 sampled patients (Patient 9). This failure had the potential to result in patients not receiving the identified care needs and services, leading to the decline in health status, affecting their quality of care and well-being. Refer to G574. The Home Health Agency (HHA) failed to ensure all physician's orders were recorded in the individualized plan of care for 3 of 17 sampled patients (Patient 2, Patient 11, and Patient 12). This failure resulted in patients not receiving their ordered treatments which placed them at risk for injury and hospitalizations. Refer to G576. The Home Health Agency (HHA) failed to promptly alert the physician for 2 of 17 sample patients (Patient 3, Patient 4) of their changes of condition and patient care outcomes are being achieved or met. This failure had the potential to result in the delay to provide further treatment and intervention including re-assessment of the patient's home bound status. Refer to G590. The Home Health Agency (HHA) failed to integrate all services in accordance with the written plan of care for one of 17 sample patients (Patient 2). This failure resulted in a cancellation of the planned home visit due to patient not being at an adult day care center causing a missed visit of the services identified in the POC. Refer to G606. The Home Health Agency (HHA) failed to ensure written information regarding the patient’s care was provided for three of 17 sampled patients (Patient 1, Patient 4, and Patient 11). This failure placed these patients at risk of not fully understanding what services to expect from the HHA, the purpose of each service, and when to expect the services. Refer to G612. The Home Health Agency (HHA) failed to provide one of 17 sample patients (Patient 9) the written information of the disciplines involved in their care and their visit frequency. This failure had the potential to result in missed visits and care services. Refer to G614. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care are provided to patients assessed to receive home health services.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure the individualized Plans of Care (POC) were implemented for five of 17 sampled patients (Patient 1, Patient 2, Patient 4, Patient 6, and Patient 11). This failure resulted in the physician not being aware of the services not being provided to the patients in accordance with the POC. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 2’s medical record form titled “OASIS Assessment” dated 3/29/2024, indicated “Risk for hospitalization – Unstable blood sugar.” During a review of Patient 2’s medical record form titled “Home Health Certification and Plan of Care- SOC (start of care)” dated 3/29/2024 to 5/27/2024, indicated “Orders for Discipline and Treatment – Fasting blood sugar: greater than (>) 300, or less than () 300, or less than ( During a review of Patient 2’s medical record form titled “Visit Notes LVN (License Vocational Nurse)” dated 4/4/2024 and 4/6/2024, indicated section “Body System Screening / Alteration in Status – Neurological, Cardiovascular, Respiratory, Immunological/Infection, Gastro-Intestinal Digestive, Nutrition, Endocrine, Genitourinary Reproductive, Musculoskeletal, Integumentary – Skin, Mobility, Safety Issues, and Fall /Incidence /Occurrence” were left blank. The forms also indicated section “Intervention provided and Pt (patient)/pcg (patient care giver) response to treatment” were left blank. Both forms were signed by License Vocational Nurse 2 (LVN2). During a telephone interview on 4/12/2024 at 9:48 a.m., with License Vocational Nurse 2 (LVN2), LVN2 stated she was assigned patient cases by the case managers. LVN2 stated when she was assigned to Patient 2, she was told the visits would only be for medication management and safety. LVN2 stated she doesn't have to assess Patient 2’s blood sugar as instructed by the case manager. LVN2 stated she was not aware of and how often Patient 2’s care giver (CG1) checks Patient 2’s blood sugar. LVN2 stated it was important follow the patients plan of care to prevent hospitalization. During a concurrent interview and record review on 4/12/2024 at 9:55 a.m. with the Director of Patient Care Services (DPCS) of Patient 2’s Electronic Medical Record (EMR), DPCS stated LVN2 did not follow Patient 2’s plan of care. DPCS stated patients plan of care needed to be followed for them to be able to reach their goals. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a review of Patient 4’s medical record form titled “OASIS-E SOC RN Assessment” dated 2/28/2024, indicated “Vital Signs Parameters – Systolic BP greater than (>) 160 or less than () 100 or less than ( During a review of Patient 4’s medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/28/2024 to 4/27/2024, indicated “Orders for Discipline and Treatment – Vital signs parameters: Systolic BP greater than (>) 160 or less than () 100 or less than (160/90 or During a joint home visit on 4/10/2024 at 9:20 a.m. with LVN1 to Patient 4’s residence at the retirement center, LVN1 took Patient 4’s blood pressure with a reading of 163/91. LVN1 stated, “your blood pressure is a bit high, is it because you are nervous?” During a concurrent interview and record review on 4/12/2024 at 11:40 a.m., with the DPCS of Patient 4’s EMR, DPCS stated he was not aware Patient 4’s blood pressure reading on 4/10/2024 was 163/91. DPCS stated there was no documentation in Patient 4’s EMR that the physician was made aware of the high blood pressure reading. DPCS stated that LVN1 should have called the physician because Patient 4 has hypertension with an increased risk of a stroke. During a review of Patient 6’s medical record form titled “Personal Information” indicated a start of care date of 3/20/2024 with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 6’ medical record form titled “Physician Order” dated 3/20/2024, indicated “Frequency of Visit – SN (skilled nurse) 2w2 (twice a week for two weeks), then SN 1w7.” During a review of Patient 6’s Electronic Medical Record (EMR) medical record form titled “Communication Log” indicated there were two entries dated 3/22/2024 and 3/25/2024 that indicated no documented reason or mention of a missed SN visit. During a review of Patient 6’s medical record form titled ““Home Health Certification and Plan of Care- SOC” dated 3/20/2024 to 5/18/2024, indicated “SN 2w2 then SN 1w7.” During a concurrent interview and record review on 4/12/2024 at 11:43 a.m. with the DPCS of Patient 6’s EMR, DPCS stated Patient 6 had three SN visit notes documented for dates 3/20/2024, 3/29/2024, and 4/5/2024. DPCS stated Patient 6 was missing three SN visits. DPCS stated there was no documented evidence in Patient 6’s EMR to indicate the reasons for the missed visits. DPCS stated the assigned nurse should have informed the physician of the missed visits to make him aware. DPCS stated the assigned nurse should have documented the reason why the visits were missed. A review of Patient 11’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). A review of Patient 11’s record titled, “Home Health Certification and Plan of Care-SOC”, for certification period 3/12/2024 to 5/10/2024, indicated the skilled nurse (SN) was to monitor the blood sugar at every visit. During an interview on 4/11/224 at 12:08 p.m., the DPCS stated Patient 11’s diagnosis of Type 2 diabetes care plan was to include monitoring for symptoms such as high blood sugar (hyperglycemia), low blood sugar (hypoglycemia), education on diet, exercise, and medication. During a concurrent interview and record review with DPCS on 4/11/2024, at 12:12 p.m., indicated Patient 11’s record titled, “Visit Notes LVN”, dated 3/15/2024, documented no blood sugar levels documented. There was no assessment of hyper or hypoglycemia. During a concurrent interview and record review on 4/11/2024, at 12:23 p.m., with DPCS titled “Visit Notes LVN”, dated 3/20/2024, no blood sugar level documented. DPCS stated if the patient’s blood sugar was normal, the SN did not need to document the blood sugar. The DPCS stated the blood sugars were not documented. If the blood sugar was not a problem, the SN could document other things that were problems during the visit. The DPCS stated the SN documented by exception. When asked, how do you know if the blood sugar was monitored? the DPCS stated, “I cannot say what they did. The chart should reflect what they did.” During a concurrent interview and record review on 4/11/2024, at 12:29 p.m., the DPCS reviewed Patient 11’s record titled, “Visit Notes LVN”, dated 3/22/2024. The DPCS stated there was no evidence the nurse monitored the blood sugars. The DPCS stated there was no documentation she provided the care as indicated in the plan of care. The DPCS stated the SN needed to specify every visit what interventions were conducted. During a concurrent interview and record review on 4/11/2024, at 12:33 p.m., the DPCS reviewed Patient 11’s record titled, “Visit Notes LVN”, dated 3/27/2024. The DPCS stated there was no evidence the nurse monitored the blood sugars. The DPCS stated there was no documentation SN provided the care as indicated in the plan of care. The DPCS stated the SN needed to specify in each visit what interventions they did. During a concurrent interview and record review on 4/11/2024, at 12:35 p.m., the DPCS reviewed Patient 11’s record titled, “Visit Notes LVN”, dated 4/3/2024. The DPCS stated there was no evidence the nurse monitored the blood sugars. The DPCS stated there was no documentation she provided the care as indicated in the plan of care. The DPCS stated the SN needed to specify in each visit what interventions they did. When asked why it was important for the nurses to follow the plan of care, the DPCS stated the plan of care was the backbone for the patient. The visits should provide knowledge and guidance on the disease process. It is difficult to monitor the patients progress because there’s no blood sugar documented. During a concurrent interview and record review on 4/11/2024 at 11:29 a.m., the DPCS reviewed Patient 11’s clinical records. The DPCS stated the record indicated Patient 11 had received 7 Certified Home Health Aide (CHHA) visits during the current certification period. The DPCS reviewed Patient 11’s record titled, “Home Health Certification and Plan of Care-SOC”, for certification period 3/12/2024 to 5/10/2024, and stated the CHHA services were not included in the plan of care. The DPCS stated there was no doctor’s order for CHHA services. The DPCS stated the order for CHHA services was supposed to be obtained on the day of admission which was 2/28/23. The DPCS stated intake coordinator scheduled CHHA services without getting a doctor’s order. During an interview on 4/12/2024 at 10:50 a.m. with the Director of Patient Care Services (DPCS), stated patients plan of care listed their needs and care. DPCS stated it was important for nurses to follow a patient plan of care because it lists the patients care needs. DPCS stated when a nurse does not follow a patients plan of care, “there is no point of the admission”. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The organization shall ensure that the patient receives all services outlined in the plan of care.” A review of facility’s policy and procedure titled “Missed Visits” revised 4/2020, indicated “Missed visits will be documented in the clinical record. If a visit is missed for any reason the clinician should attempt to rescheduled it for the same week so that the physician ordered frequency is maintained and would not be considered a missed visit.” A review of facility’s policy and procedure titled “Monitoring Patients Response/Reporting to Physician” revised 4/2020, indicated “Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. During each home visit, the clinician will monitor the patient’s response to care against the established goals, including, but not limited to: When a visit is missed for any reason.” A review of facility’s policy and procedure titled “Entries into the Clinical Record” revised 4/2020, indicated “Entries into the clinical record will be made on the day care is provided to the patient. All documentation will be turned in to the office at the end of the workday and clinical notes dictated or written will be incorporated into the patient’s health record at least every seven working days. Amendments, corrections or late entries within an electronic health record must: distinctly identify any amendment, correction, or late entry.” . During a review of Patient 1’s medical record form titled “Personal Information” indicated a start of care date of 1/19/2024 with a primary diagnosis of Alzheimer’s Disease, urinary tract infection (UTI- dehydration (lack of fluid the body needs to function properly) and pain in right hip. During a review of Patient 1’s medical record form titled “OASIS Assessment” dated 3/16/2024, indicated “Risk for hospitalization due to decline in mental, emotional, and behavioral Status in the past 3 months. During a review of Patient 1’s medical record form titled “Home Health Certification and Plan of Care- SOC (start of care)” dated 1/19/2024, for the certification period of 1/19/2024 to 3/18/2024 and 3/19/2024 to 5/17/2024, indicated “Orders for Discipline and Treatment for the skilled nurse to visit two times a week for 1 week, for the week of 3/24/2024 to 3/30/2024, and one time a week for 6 weeks for the period of 3/30/3034 to 5/17/2024 to assess vital signs parameter, observe history of difficulty complying with any medical instructions for example medications diet exercise in the past three months. During a review of Patient 1’s electronic medical record form titled “Visit Notes LVN (License Vocational Nurse)” indicated the LVN visited patient on 2/17/2023, 2/28/2024, and 3/6/2024, and that the Registered Nurse visited patient on 2/9/2024, and 2/18/2024. dated 4/4/2024 and 4/6/2024, indicated section “Body System Screening / Alteration in Status – Neurological, Cardiovascular, Respiratory, Immunological/Infection, Gastro-Intestinal Digestive, Nutrition, Endocrine, Genitourinary Reproductive, Musculoskeletal, Integumentary – Skin, Mobility, Safety Issues, and Fall /Incidence /Occurrence” were left blank. The forms also indicated section “Intervention provided and response to treatment” were left blank. On 4/10/2024, at 10 a.m., during a concurrent home visit at Patient 1's residence with RN 1, RN 1 stated this is the first time she visited Patient 1, and she works, per diem for the HHA. During the home visit and interview with Patient 1’s caregiver, the caregiver stated this is the third skilled nurse visit from the HHA since Patient 1's start of care on 1/19/2024. The PCG stated she was surprised to see RN 1 took the patient's vital signs while the other two prior visits, the Skilled Nurses (SN) never assessed/touched the patients to take vital signs. During a telephone interview on 4/12/2024 at 9:48 a.m., with Patient 1’s family member, she stated the patient had only received 3 visits from the HHA nurses and that the HHA had not contacted her to visit the patient until the other day. During a concurrent interview and record review on 4/12/2024 at 9:55 a.m., with the Director of Patient Care Services (DPCS) of Patient 1’s Electronic Medical Record (EMR), and family interview, the DPCS stated he was not aware the patient did not receive any visits and could not explain the validity of the SN notes. DPCS stated patients plan of care need to be followed for them to be able to reach their goals. DPCS stated she would have to follow-up on the visit and that it is the Case managers responsibility to ensure the visits are being provided.

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) failed to include the disciplines and the visit frequencies in the plan of care (POC) for one of 17 sampled patients (Patient 9). This failure had the potential to result in patients not receiving the identified care needs and services, leading to the decline in health status, affecting their quality of care and well-being. During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of athesclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). During a review of Patient 9’s medical record form titled “Physician Order” dated 2/15/2024, indicated “Frequency of Visit – SN (skilled nurse) 2w2 (twice a week for 2 weeks), SN 1w7, and PT (physical therapy) 1w5.” During a review of Patient 9’s medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/16/2024 to 4/15/2024, did not indicate Patient 9’s ordered disciplines and their visit frequencies. During a concurrent interview and record review on 4/12/2024 at 1:11 p.m. with the Director of Patient Care Services (DPCS) of Patient 9’s Electronic Medical Record (EMR) medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/16/2024 to 4/15/2024 was reviewed. DPCS stated Patient 9’s plan of care did have the disciplines with their visit frequency listed. DPCS stated the disciplines involved in the patients care and their frequency should be documented so the patient and family are aware of who and when will visit. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The goals of care, the interventions that support those goals and the identification of the staff providing services. The establishment and revision of the plan of care, including the disciplines that will furnish the care and the frequency of visits as well as any changes in the care to be furnished.” A review of facility’s policy and procedure titled “Care Planning Process” revised 4/2020, indicated “The organization shall provide the patient and caregiver with a copy of written instructions outlining: visit schedule… patient medication… education… any treatment… any other pertinent instruction related to the patients care and treatments…” During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of atherosclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). During a review of Patient 9’s medical record form titled “Physician Order” dated 2/15/2024, indicated “Frequency of Visit – SN (skilled nurse) 2w2 (twice a week for 2 weeks), SN 1w7, and PT (physical therapy) 1w5.” During a review of Patient 9’s medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/16/2024 to 4/15/2024, did not indicate Patient 9’s ordered disciplines and their visit frequencies. During a concurrent interview and record review on 4/12/2024 at 1:11 p.m. with the Director of Patient Care Services (DPCS) of Patient 9’s Electronic Medical Record (EMR) medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/16/2024 to 4/15/2024 was reviewed. DPCS stated Patient 9’s plan of care did have the disciplines with their visit frequency listed. DPCS stated the disciplines involved in the patients care and their frequency should be documented so the patient and family are aware of who and when will be the visit. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The goals of care, the interventions that support those goals and the identification of the staff providing services. The establishment and revision of the plan of care, including the disciplines that will furnish the care and the frequency of visits as well as any changes in the care to be furnished.” A review of facility’s policy and procedure titled “Care Planning Process” revised 4/2020, indicated “The organization shall provide the patient and caregiver with a copy of written instructions outlining: visit schedule… patient medication… education… any treatment… any other pertinent instruction related to the patients care and treatments…” ..

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure all physician orders were recorded in the individualized plan of care for 3 of 17 sampled patients (Patient 2, Patient 11, and Patient 12). This failure resulted in patients not receiving their ordered treatments which placed them at risk for injury and hospitalizations. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes melitus (high blood sugar). During a review of Patient 2’s medical record form titled “OASIS Assessment” dated 3/29/2024, indicated “Physical therapy would be beneficial to restore strength and balance. Home health aide for temporary assistance for bathing and ADLs (Activities of daily living).” During a review of Patient 2’s medical record form titled “Encounter- Home Visit” dated 3/28/2024, indicated “Plan – Refer to PT (Physical Therapy) for evaluation, strengthening and gait balance. Reinforce proper use of assistive devices. Refer to HHA (Home Health Aide) for bathing and ADLs (activity of daily living) assistance.” During a review of Patient 2’s medical record form titled “Physician Order” dated 3/29/2024, indicated “Refer to PT (Physical Therapy) for evaluation, strengthening and gait balance. Reinforce proper use of assistive devices. Refer to HHA (Home Health Aide) for bathing and ADLs (activity of daily living) assistance.” During a review of Patient 2’s medical record form titled “Home Health Certification and Plan of Care- SOC (start of care)” dated 3/29/2024 to 5/27/2024, indicated RN (registered nurse) 1W1 (once a week for one week); SN (skilled nurse) 2W1; SN 1W7.” The form also indicated there was no documentation for PT and CHHA services. During a concurrent interview and record review on 4/12/2024 at 9:55 a.m., with the Director of Patient Care Services (DPCS) of Patient 2’s Electronic Medical Record (EMR), DPCS stated Patient 2’s plan of care indicated the following disciplines and their frequencies RN 1W1; SN 2W1; then SN 1W7. DPCS stated Patient 2 was not evaluated by PT. DPCS stated Patient 2 was receiving home health services due to her diabetic neuropathy (nerve pain) on her legs and would benefit from PT for safety and fall management reasons. DPCS stated Patient 2’s ADLs might not be met because the HHA has not assign CHHA services. DPCS stated the HHA was not providing the physician ordered for Patient 2. A review of Patient 11’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). During an interview at the home visit on 4/10/2024, at 11:05 a.m., Patient 11’s caregiver (CG 3) stated Patient 11 was receiving physical therapy (PT) services every week. During a concurrent interview and record review on 4/11/2024 at 12 p.m., the DPCS reviewed Patient 11’s record titled, “Home Health Certification and Plan of Care-SOC”, for certification period 3/12/2024 to 5/10/2024. The DPCS stated the record did not include the PT and occupational therapy (OT) order as indicated in the record titled, “Patient Referral & Orders”, dated 3/11/2024. The DPCS stated the order for PT and OT were not included in the POC because the orders were sent via facsimile separately. When asked why it was important for the doctor’s orders to be included in the plan of care, the DPCS stated it was easier for the doctor if you have one sheet. If everything is there. The doctors don’t want to sign many papers. So, it is easier for them to sign if everything is on one paper. A review of Patient 12’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). During a concurrent interview and record review, on 4/11/2024, at 12:45 p.m., the DPCS reviewed Patient 12’s records titled, “Encounter”, dated 3/11/2024 and “Home Health Certification and Plan of Care-SOC”, for certification period 3/12/2024-5/10/2024. The DPCS stated the “Encounter” record indicated Patient 12’s provider ordered SN, PT, CHHA, and Medical Social Worker (MSW) services. The DPCS stated the only order included in the plan of care was SN services. The DPCS continued to review Patient 12’s records and stated he did not think the MSW saw the patient and did not know what happened because there was nothing documented about it. During a concurrent interview and record review on 4/11/2024, at 1 p.m., the DPCS reviewed Patient 12’s record titled, “SOC Med Profile/Frequency”, dated 3/12/2024. The DPCS stated the document was the order that includes SN and PT. The DPCS stated whoever took the order should have documented the MSW and HHA were declined by the patient. When asked how the DPCS knew the patient had declined, the DPCS stated the HHA and MSW orders were not included. Most likely the patient declined, staff just did not document. The DPCS stated he need to investigate to determine if the patient declined or not. There was no documented evidence the patient declined HHA and MSW services. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The goals of care, the interventions that support those goals and the identification of the staff providing services. The establishment and revision of the plan of care, including the disciplines that will furnish the care and the frequency of visits as well as any changes in the care to be furnished.” A review of facility’s policy and procedure titled “Monitoring Patients Response/Reporting to Physician” revised 4/2020, indicated “Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. During each home visit, the clinician will monitor the patient’s response to care against the established goals, including, but not limited to: All physician orders shall be integrated into the plan of care.” A review of facility’s policy and procedure titled “Care Planning Process” revised 4/2020, indicated “Based on the assessment and conclusions, the plan of care will include, but not be limited to: All patient care orders from all physicians involved in the plan of care, including verbal orders.”

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to promptly alert the physician for 2 of 17 sample patients (Patient 3, Patient 4) of their changes of condition and patient care outcomes are being achieved or met. This failure had the potential to result in the delay to provide further treatment and intervention including re-assessment of the patient's home bound status. A review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). A review of Patient 3’s medical record form titled “Home Health Certification and Plan of Care” dated 2/28/2024 to 4/27/2024, indicated “Home bound status: Criteria A: 1. Because of illness of injury: Needs supportive device to ambulate: Cane. 2. Condition is such that leaving a home is medically contraindicated: Unable to go out alone: Residual weakness. Criteria B: 1. Normal inability to leave home: Other: needs assistive device. 2. Leaving home requires considerable and taxing effort: Other: needs cane.” During a joint home visit on 4/10/2024 at 9 a.m., with License Vocational Nurse 1 (LVN1) at Patient 3’s residence at the retirement center, Patient 3 was not at facility. LVN1 asked the retirement centers Medication Tech (MT) and Office Manager (OM) where Patient 3 was. OM and MT stated the retirement center was an “in and out” facility. OM stated Patient 3 had just left and stated he was going to the Department of Motors and Vehicles (DMV). LVN1 stated he will continue to the next patient visit because Patient 3 was not at retirement center. During a telephone interview on 4/11/2024 at 12:44 p.m. with Physical Therapist 1 (PT1). PT1 stated she had provided Patient 3 physical therapy services three times. PT1 stated Patient 3 did not use a cane or walker to ambulate. PT1 stated Patient 3 used handrails in the hallway to ambulate. PT1 stated she did not see a cane or walker in Patient 3’s bedroom. During a concurrent interview and record review on 4/12/2024 at 11:20 a.m. with the Director of Patient Care Services (DPCS) of Patient 3’s Electronic Medical Record (EMR), DPCS stated he was not aware Patient 3 missed a Skilled Nurse home visit because he went to the DMV. DPCS stated there was no documentation that the physician was made aware of Patient 3 going to the DMV and not using a cane or walker when ambulating. DPCS stated the physician needed to be made aware as soon as possible to be able to review and update Patient 3’s plan of care. DPCS stated that if Patient 3 was ambulating without a walker or cane he needed to be discharged. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a review of Patient 4’s medical record form titled “OASIS-E SOC RN Assessment” dated 2/28/2024, indicated “Vital Signs Parameters – Systolic BP greater than (>) 160 or less than () 100 or less than ( During a review of Patient 4’s medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/28/2024 to 4/27/2024, indicated “Orders for Discipline and Treatment – Vital signs parameters: Systolic BP greater than (>) 160 or less than () 100 or less than (160/90 or During a joint home visit on 4/10/2024 at 9:20 a.m. with LVN1 to Patient 4’s retirement center, home, LVN1 took Patient 4’s blood pressure with a reading of 163/91. LVN1 stated, “your blood pressure is a bit high, is it because you are nervous?” During a concurrent interview and record review on 4/12/2024 at 11:40 a.m., with the DPCS of Patient 4’s EMR, DPCS stated he was not aware Patient 4’s blood pressure reading on 4/10/2024 was 163/91. DPCS stated there was no documentation in Patient 4’s EMR that the physician was made aware of the blood pressure reading. DPCS stated that LVN1 should have called the physician because Patient 4 has hypertension with an increased risk of a stroke. A review of facility’s policy and procedure titled “Monitoring Patients Response/Reporting to Physician” revised 4/2020, indicated “Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. The patient’s physician will be contacted on the same day when any of the following occur: Changes in the patient’s condition. Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions, and limitations).” A review of facility’s policy and procedure titled “Ongoing Assessment” revised 4/2020, indicated “During each home visit, the clinician or other discipline will reevaluate the patient according to the problems identified during the initial visit and subsequent visits. Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: blood pressure, pulse, respiration, temperature. Functional status. Compliance with treatment and/or medications.” A review of facility’s policy and procedure titled “Patient Notification of Changes in Care” revised 4/2020, indicated “Any significant changes will be called into the office. Documentation of the notification will include: date and time of notification. Specific changes in the plan of care. Patient response or acceptance.” A review of facility’s policy and procedure titled “Initial and Comprehensive Assessment” revised 4/2020, indicated “The assessment will be patient-specific and comprehensive to include the patients need for home health care, rehabilitative care, social services, and discharge planning. This assessment will measure patient outcomes from data collected at the start of care and at the following defined intervals thereafter: Significant change in condition per the agency policy and definition. The comprehensive assessment shall reflect and determine: The patients continuing need for home health care. The patient is eligible for payment (e.g., homebound status).” A review of facility’s policy and procedure titled “Care Planning Process” revised 4/2020, indicated “All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: Changes in patient’s condition. Clinicians will inform the patients physician of any changes that suggest a need to alter the plan of care.”

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to integrate all services in accordance with the written plan of care for one of 17 sample patients (Patient 2). This failure resulted in a cancellation of the planned home visit due to patient not being at an adult day care center causing the missed visit of the services identified in the POC. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 2’s medical record form titled “OASIS Assessment” dated 3/29/2024, did not indicate Patient 2 attended an adult day care center from Monday through Friday. During a review of Patient 2’s medical record form titled “Home Health Certification and Plan of Care- SOC” dated 3/29/2024 to 5/27/2024, did not indicate Patient 2 attended an adult day care center from Monday through Friday. During an interview on 4/9/2024 at 2 p.m. with the Administrator (ADM), the ADM stated Patient 2’s daughter/care giver 1 (CG1) agreed to a joint home visit on 4/10/2024 at 12 p.m. During a telephone interview on 4/10/2024 at 11:46 a.m. with License Vocational Nurse 1 (LVN1), LVN1 stated Patient 2’s scheduled home visit at 12 p.m. was cancelled. LVN1 stated Patient 2’s daughter/care giver 1 (CG1) stated over the phone that Patient 2 had an appointment and will not be home. During a telephone interview on 4/11/2024 at 10:38 a.m. with CG1, CG1 stated Patient 2 attends an adult day care center Monday through Friday from 7:20-7:30 a.m. till 2:30-3 p.m. CG1 stated that someone from the HHA called her on 4/10/2024 to confirm a home visit appointment, and that she reminded them that Patient 2 was at day care at 12 p.m. CG1 stated Patient 2 had been attending the adult day care since before 2020. CG1 stated Patient 2 started receiving home health services on 3/29/2024, and has seen two HHA personnel, the Nurse Practitioner and the admitting Registered Nurse only. CG1 stated she did not know who License Vocational Nurse 2 was. During a review of Patient 2’s medical record form titled “Visit Notes LVN (License Vocational Nurse)” dated 4/4/2024 and 4/6/2024, indicated LVN2 conducted a skilled nurse home visit on 4/4/2024 from 9 a.m. till 10 a.m. and on 4/6/2024 from 9 a.m. till 10 a.m. During a telephone interview on 4/12/2024 at 9:48 a.m. with License Vocational Nurse 2 (LVN2), LVN2 stated she is assigned patient cases by an HHA case managers. LVN2 stated when she was assigned to Patient 2, she was told the visits will be for medication management and safety. LVN2 stated she does not assess Patient 2’s blood sugar because she was not told to by the case manager. LVN2 stated she is not aware if and how often Patient 2’s care giver (CG1) checks Patient 2’s blood sugar. LVN2 stated it was important to follow a patients plan of care to prevent hospitalization. During a concurrent interview and record review on 4/12/2024 at 9:55 a.m. with the Director of Patient Care Services (DPCS) of Patient 2’s Electronic Medical Record (EMR), DPCS stated he was not aware that Patient 2 attended an adult day care Monday thru Friday from 7:30 a.m. till 2:30-3 p.m. During a telephone interview on 4/12/2024 at 12:11 a.m. with Nurse Practitioner 1 (NP1), NP1 stated he conducted Patient 2’s assessment that determine Patient 2’s qualification to receive home health services. NP1 stated he was not aware Patient 2 attended an adult day care center. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The goals of care, the interventions that support those goals and the identification of the staff providing services. The organization shall ensure that the patient receives all services outlined in the plan of care.” A review of facility’s policy and procedure titled “Entries into the Clinical Record” revised 4/2020, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect th3e care or services provided. Times means actual time that an event occurred, which is not necessarily the time when the documentation was entered into the record.”

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure written information regarding the patient’s care was provided for three of 17 sampled patients (Patient 1, Patient 4 and Patient 11). This failure placed these patients at risk of not fully understanding what services to expect from the HHA, the purpose of each service, and when to expect the services. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a joint home visit on 4/10/2024 at 9:20 a.m. with LVN1 to Patient 4’s retirement center, home, LVN1 was not able to locate Patient 4’s written plan of care. LVN1 stated it was the admitting nurse was to provide the patient a copy of her plan of care to make everyone aware of her planned care. During an interview on 4/10/2024 at 9:50 a.m. with Patient 4’s retirement center Medication Technician (MT), MT stated she provides medications to all the patients at the retirement center. MT stated she did not have Patient ‘s plan of care or any information from the HHA. MT stated, “the home health probably gave the patients their med list and their plan.” A review of Patient 11’s record titled, “Personal Information”, indicated a start of care on 3/12/2024, with a primary diagnosis of Type 2 diabetes mellitus (high blood sugar). During a concurrent observation and interview at the home visit on 4/10/2024, at 11:40 a.m., Patient 11’s caregiver (CG 3) reviewed the folder and booklet the HHA provided. CG 3 stated he could not find a plan of care in the folder. CG 3 stated he had never received a copy of the plan of care. During an interview on 4/11/2024, at 12:43 p.m., the DPCS stated patients were supposed to get a copy of their plan of care, to show they were involved in the care planning process. The plan of care guides the patient so they know how many times the clinician will come to the house. The plan of care is the main factor of the home health visit. During an interview on 4/12/2024 at 10:50 a.m. with the Director of Patient Care Services (DPCS), DPCS stated patients should be provided with their plan of care which list the disciplines with their frequencies, goals, interventions, the start, and end date. DPCS stated if patient do have their plan of care at home, they run the risk of missing treatments that could potentially cause problems. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The goals of care, the interventions that support those goals and the identification of the staff providing services. The establishment and revision of the plan of care, including the disciplines that will furnish the care and the frequency of visits as well as any changes in the care to be furnished.” A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “If eligibility criteria are met, the patient and family caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: nature and goals of care and services. Available community resources. Other organization personnel involved in care.” A review of facility’s policy and procedure titled “Care Planning Process” revised 4/2020, indicated “The organization shall provide the patient and caregiver with a copy of written instructions outlining: visit schedule… patient medication… education… any treatment… any other pertinent instruction related to the patients care and treatments…” During a review of Patient 1’s medical record form titled “Personal Information” indicated a start of care date of 1/19/2024 with a primary diagnosis of Alzheimer’s Disease, urinary tract infection -, dehydration (lack of fluid needed for the body to function) and pain in right hip. During a joint home visit on 4/10/2024, at 10: 00 a.m., with RN 1, and Patient 1’s care giver in Patient 1’s residence. RN 1 asked patient the caregiver for the HHA’s folder so she could go over the POC with the caregiver, and the caregiver, to the RN and surveyor, that there was no folder in the resident and that the last nurse that visited Patient 1 over a month ago took the folder with her and they were not aware of the patients plan of care.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to provide one of 17 sample patients (Patient 9) written information of the disciplines involved in their care and their visit frequency. This failure had the potential to result in missed visits and care services. During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of atherosclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). During a review of Patient 9’s medical record form titled “Physician Order” dated 2/15/2024, indicated “Frequency of Visit – SN (skilled nurse) 2w2 (twice a week for 2 weeks), SN 1w7, and PT (physical therapy) 1w5.” During a review of Patient 9’s medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/16/2024 to 4/15/2024, did not indicate Patient 9’s ordered disciplines and their visit frequencies. During a concurrent interview and record review on 4/12/2024 at 1:11 p.m. with the Director of Patient Care Services (DPCS) of Patient 9’s Electronic Medical Record (EMR) medical record form titled “Home Health Certification and Plan of Care- SOC” dated 2/16/2024 to 4/15/2024 was reviewed. DPCS stated Patient 9’s plan of care did have the disciplines with their visit frequency listed. DPCS stated the disciplines involved in the patients care and their frequency should be documented so the patient and family are aware of who and when will visit. A review of facility’s policy and procedure titled “Rights/Responsibilities” revised 4/2020, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care to the patient, of the following: The goals of care, the interventions that support those goals and the identification of the staff providing services. The establishment and revision of the plan of care, including the disciplines that will furnish the care and the frequency of visits as well as any changes in the care to be furnished.” A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “If eligibility criteria are met, the patient and family caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: nature and goals of care and services. Available community resources. Other organization personnel involved in care.”

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the administrator confirmed the HHA was approved in providing services outside of the approved Geographic Service Area (GSA) for three of 17 sampled patients (Patient 5, Patient 16, and Patient 17). A review of Patient 16’s record titled, “Personal Information”, indicated a start of care on 3/28/2024, with a primary diagnosis of Malignant neoplasm of unspecified main bronchus (lung cancer). The record also indicated the patient lived in Kern County, California. A review of Patient 17’s record titled, “Personal Information”, indicated a start of care on 7/13/2023, with a diagnosis of hypertensive heart disease with heart failure (high blood pressure, heart not pumping enough blood and oxygen to the body) and an end of care date on 11/1/2023. Further review of the record indicated the patient lived in Calexico, California (Imperial County). During an interview on 4/9/2024, at 2:45 p.m., the Administrator (ADM) stated the HHA was not taking care of patient in San Diego County. The ADM stated the HHA had applied to Centers of Medicaid Services (CMS) for approval to deliver services in San Diego and Kern County on 2/1/2024. During a concurrent interview and record review on 4/9/2024 at 3 p.m. with the ADM of facility’s form titled “Reject/Withdrawn Medicare Application” dated 4/9/2024, the form indicated in section “From section 4: Practice Location Information – Geographical Location” Kern and San Diego California were added by the ADM to be effective on 2/1/2024. ADM stated they are still waiting for the approval. A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “Once a patient is admitted to service, the organization will be responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations. The patient must reside within the geographical area that (HHA) serves.” A review of facility’s policy and procedure titled “Scope of Services” revised 4/2020, indicated “(HHA) will provide care to persons living within the following counties:” The form indicated there were no counties listed.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure they had a written service agreement for two of 17 sample patients (Patient 3 and Patient 4). This failure had the potential to cause confusion about who are responsible for the patients care. During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a joint home visit on 4/10/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) to Patient 3’s residence at the retirement center. LVN1 singed in at Patient 3’s retirement center and headed to Patient 3’s room #17. LVN1 stated Patient 3 was not in room and will ask retirement center office on his whereabouts. Patient 3’s retirement center Medication Technician (MT) stated the retirement center was an “in and out” facility. MT stated Patient 3 was awake, alert and ambulatory. Retirement center Office Manager (OM) stated Patient 3 left the retirement center by himself and stated he was going to the Department of Motor and Vehicles. OM stated Patient 3 is independent. LVN1 did not ask the retirement staff to view Patient 3 medications or his medication list or if there were any changes to his medication. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a review of Patient 4’s HHA’s medical record form titled “Medication Profile” indicated Patient 4 was taking Aripiprazole (antipsychotic medication), Carvedilol (high blood pressure medication) 3.125 mg (milligrams) daily, Divalproex (seizure medication) 250 mg daily, Losartan (high blood pressure medication), and Mirtazapine (anti depression medication). During a review of Patient 4’s retirement center untitled medication list indicated Patient 4 was taking Aripiprazole, Carvedilol 3.125 mg twice daily, Divalproex 250 mg twice daily, Losartan, Mirtazapine, Ondansetron (anti nausea/vomiting medication), Zolpidem (sleep aid medication), Acetaminophen (pain medication), Docusate sodium (stool softener medication), and Loratadine (allergy medication). During a joint home visit on 4/10/2024 at 9:20 a.m. with LVN1 to Patient 4’s retirement center, home. LVN1 singed in at Patient 4’s retirement center and headed to Patient 4’s room #14. LVN1 stated Patient 4 was not in room and will ask retirement center office on her whereabouts. MT stated she saw Patient 4 in the front patio. Patient 4 noted ambulating with a slow steady gait outside of retirement center. Patient 4 ambulated with a slow steady gait to her room. LVN1 did not ask the retirement staff to view Patient 4 medications or her medication list or if there were any changes to her medication. During an interview on 4/10/2024 at 9:50 a.m. with MT, MT stated she provides medications to all the patients at the retirement center, including Patient 3 and Patient 4. MT stated she did not have the HHAs medication lists, or plan of care for Patient 3 or Patient 4’s or any information from the HHA. MT stated, “the home health probably gave the patients their med list and their plan.” During a concurrent interview and record review on 4/12/2024 at 11:40 a.m. with the DPCS of Patient 4’s EMR, DPCS stated Patient 4’s retirement facility and HHA’s medication sheets were not the same. DPCS stated the HHA needed to coordinate with Patient 4’s retirement facility for the patient's wellness. During a phone interview on 4/10/2024 at 11:46 a.m. with LVN1, LVN1 stated he reconciles patient medication every two weeks. LVN1 stated medication reconciliation is important to keep track of patient's current medications and to update the HHA medication profile. During an interview on 4/12/2024 at 10:50 a.m. with the Director of Patient Care Services (DPCS), DPCS stated when a patient is admitted, it is the responsibility of the admitting nurse to reconcile all the patients’ medications. DPCS stated medication reconciliation occurs at every nursing visit to ensure the current medications are listed on their medication profile. DPCS stated medication reconciliation is needed to ensure the patients response to the effectiveness of the medications are noted. DPCS stated when patients’ medications are not reconciled, the HHA is unable to assist patients sustain their health and maintenance of their medications. During an interview on 4/12/2024 at 11:16 a.m. with the Director of Patient Care Services (DPCS), DPCS was requested to provide the service agreements for Patient 3 and Patient 4 who reside at a retirement center where the staff at the center administer their medications and provide supervision. DPCS stated the HHA did not have service agreements for either patient. DPCS stated the HHA treat the retirement center as the patient’s home. DPCS stated that since the retirement center staff administers Patient 3 and Patient 4 their medication, the visiting nurse should ask to check the patients’ medications. A review of facility’s policy and procedure titled “Admission Criteria and Process” revised 4/2020, indicated “A copy of the patient’s service agreement with the facility will be viewed to ensure that home health services ordered and provided are not duplicative of those services or required to be provided by the facility.” A review of facility’s policy and procedure titled “Medication Profile” revised 4/2020, indicated “For accuracy and to completely reconcile medications across the continuum of care, the admitting organization will obtain and document a complete list of the patient’s current medication s upon the patient’s entry to the organization. A comparison of the medications ordered for the patient while under the organization care will be made to those on the list. During subsequent home visits, the medication profile will because as a care planning tool and teaching guide to ensure that the patient and family caregiver, as well as other clinicians, understand the medication regimen. The medication profile and other relevant data will be available to all clinicians providing care.” A review of facility’s policy and procedure titled “Monitoring Patients Response/Reporting to Physician” revised 4/2020, indicated “Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. During each home visit, the clinician will monitor the patient’s response to care against the established goals, including, but not limited to: Care interventions and treatments.” A review of facility’s policy and procedure titled “Ongoing Assessment” revised 4/2020, indicated “During each home visit, the clinician or other discipline will reevaluate the patient according to the problems identified during the initial visit and subsequent visits. Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: blood pressure, pulse, respiration, temperature. Functional status. Compliance with treatment and/or medications.”

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Clinical Records are met as follows: Failed to ensure patient care records were safeguarded against unauthorized used for seven of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, and Patient 16). This failure resulted in the patients protected health information (PHI) being accessed by unauthorized personnel and the confidentiality of patient information are being compromised. Refer to G1012. Failed to ensure patient care records were safeguarded against unauthorized used for seven of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, and Patient 16). This failure resulted in the patients protected health information (PHI) being accessed by unauthorized personnel and the confidentiality of patient information are being compromised. Refer to G1028. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Clinical Records to ensure patient's health information are safeguarded and protected.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure three of 17 sampled patients (Patient 2, Patient 3, and Patient 14) clinical records included completed clinical notes of all services provided. This failure resulted in an incomplete clinical records and confusion if visits were missed or not. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a concurrent interview and record review on 4/12/2024 at 9:55 a.m. with the Director of Patient Care Services (DPCS) of Patient 2’s Electronic Medical Record (EMR) medical record form titled “Visit Notes LVN (License Vocational Nurse)” dated 4/4/2024 and 4/6/2024 were reviewed. DPCS stated section “Body System Screening / Alteration in Status – Neurological, Cardiovascular, Respiratory, Immunological/Infection, Gastro-Intestinal Digestive, Nutrition, Endocrine, Genitourinary Reproductive, Musculoskeletal, Integumentary – Skin, Mobility, Safety Issues, and Fall /Incidence /Occurrence” were left blank. DPCS stated LVN2 should have marked “no issues noted” instead of leaving it blank. DPCS stated the notes were not complete. During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a concurrent interview and record review on 4/12/2024 at 11:20 a.m. with the DPCS of Patient 3’s EMR medical record form titled “Visit Notes LVN (License Vocational Nurse)” dated 3/31/2024 was reviewed. DPCS stated the note was not complete. DPCS stated the nurse needed to complete the note for other HHA personnel can view and read about the patients care to be able to compare from the previous visit. A review of facility’s policy and procedure titled “Entries into the Clinical Record” revised 4/2020, indicated “Entries into the clinical record will be made on the day care is provided to the patient. All documentation will be turned into the office at the end of the workday and clinical notes dictated or written will be incorporated into the patient’s health record at least every seven working days. Late entries and amendments will be documented, stating “late entry or amendment for visit of (date and time of visit)” … Amendments, corrections, or late entries within an electronic health record must: distinctly identify any amendment, correction, or late entry. . During a review of Patient 14’s electronic medical record form title, “ Personal Information”, indicated a start of care date of 4/1//2024 with primary diagnosis of Hypertensive heart disease with heart failure ( problems with your heart that developed from uncontrolled high blood pressure over a period of time) During a review of Patient 104s medical record form titled, “ Home Health Certification and Plan of Care -SOC” for the certification period of 4/1/2024 to 5/30/2024, the physician orderd skilled nurse visit two times a week for 2 weeks and from 4/1/2024 to 4/13/2024, and one time a week for 7 weeks for home safety and medication management. There were no Skilled nurse’s notes in patient 14’s electronic medical record. During a concurrent record review and interview with the DPCS in the HHA’s conference room on 4/12/2024, at 11:40 a.m., stated the nurse should have completed her notes.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure patient care records were safeguarded against unauthorized used for seven of 17 sampled patients (Patient 2, Patient 3, Patient 4, Patient 6, Patient 7, Patient 9, and Patient 16). This failure resulted in the patients protected health information (PHI) being accessed by unauthorized personnel and the confidentiality of patient information are being compromised. During a review of Patient 2’s medical record form titled “Personal Information” indicated a start of care date of 3/29/2024 with a primary diagnosis of type II diabetes mellitus (high blood sugar). During a review of Patient 2’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 2’s Electronic Medical Record (EMR) on 4/5/2024. During a review of Patient 3’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of chronic obstructive pulmonary disease (set of lung issues making it difficult to breath). During a review of Patient 3’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient ’s Electronic Medical Record (EMR) on 4/10/2024. During a review of Patient 4’s medical record form titled “Personal Information” indicated a start of care date of 2/28/2024 with a primary diagnosis of hypertension (high blood pressure). During a review of Patient 4’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 4’s Electronic Medical Record (EMR) on 4/9/2024. During a review of Patient 6’s medical record form titled “Personal Information” indicated a start of care date of 3/20/2024 with a primary diagnosis of hypertensive (high blood pressure) heart disease without heart failure. During a review of Patient 6’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 6’s Electronic Medical Record (EMR) on 4/3/2024 and 4/8/2024. During a review of Patient 7’s medical record form titled “Personal Information” indicated a start of care date of 4/4/2024 with a primary diagnosis of osteopososis with current path fracture (broken bone) right femur. During a review of Patient 7’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 7’s Electronic Medical Record (EMR) on 4/9/2024 and 4/10/2024. During a review of Patient 9’s medical record form titled “Personal Information” indicated a start of care date of 12/18/2023 and an end of care date of 4/8/2024, with a primary diagnosis of atherosclerotic heart disease of native coronary artery (narrow heart arteries) without angina pectoris (chest pain). During a review of Patient 9’s medical record form titled “Audit log” dated from 3/26/2024 to 4/12/2024, indicated Quality Assurance 1 (QA1) accessed and documented in Patient 9’s Electronic Medical Record (EMR) on 4/9/2024. A review of Patient 16’s record titled, “Personal Information”, indicated a start of care on 3/29/2024, with a primary diagnosis of Malignant neoplasm of unspecified main bronchus (lung cancer). During a concurrent interview and record review on 4/12/2024, at 9:45 a.m., the DPCS reviewed Patient 16’s record titled, “Audit Log”, dated 3/28/2024 to 4/12/2024. The record indicated QA 1 had made modifications to the document titled OASIS-SOC (a document that describes the nursing assessment done for admission into the HHA) from 4/8/2024 to 4/10/2024. The modifications included changes to the narrative (care coordination/narrative) such as changing the previous value of “to refer to physical therapy, refer to occupational therapy, refer to MSW” to “refer to Physical Therapy: N/A (N/A not applicable), Refer to Occupational Therapy: N/A, Refer to MSW: N/A. The DPCS stated QA 1 was not available for an interview because she was in the Philippines. During an interview on 4/12/2024 at 9:55 a.m. with the Director of Patient Care Services (DPCS), DPCS stated Quality Assurance 1 (QA1) was granted access to HHAs patients EMR and worked remotely from Manila, Philippines. DPCS stated QA1 is responsible for reviewing assigned patients EMRs and send a written report if there are any discrepancies. DPCS stated QA1 was not supposed to document in patients EMR because she is not physically seeing the patients. During an interview on 4/12/2024 at 2:55 p.m. with the Director of Patient Care Services (DPCS), DPCS stated the HHA did not have employee records/files for both contracted QA1 and QA2 who worked remotely out of the country and had clinical access to patients EMRs. DPCS stated contracted employee files were needed to ensure the personnel were competent and had their criminal background checked. DPCS stated both contracted QA were not licensed in California, and he did not have proof that they were licensed nurses. During an interview on 4/12/2024, at 10:35 a.m., the Chief Executive Officer (CEO) stated the HHA outsourced to a 3rd party company that used staff from the Philippines to do the quality assurance, because it is cheaper. The CEO stated, “Do you know how expensive Q.A is here in the USA? Medicare doesn’t pay enough. That is a legitimate business. They are licensed, what is the violation here?” During an interview on 4/12/2024 at 9:55 a.m. with the Director of Patient Care Services (DPCS), DPCS stated Quality Assurance 1 (QA1) was granted access to HHAs patients EMR and worked remotely from Philipine Manila. DPCS stated QA1 is responsible for reviewing assigned patients EMRs and send a written report if there are any discrepencies. DPCS stated QA1 was not supposed to document in patients EMR because she is not physically seeing the patients. During an interview on 4/12/2024 at 2:55 p.m. with the Director of Patient Care Services (DPCS), DPCS stated the HHA did not have employee records/files for both contracted QA1 and QA2 who worked remotely out of the country and had clinical access to patients EMRs. DPCS stated contracted employee files were needed to ensure the personnel were competent and had their criminal background checked. DPCS stated both contracted QA were not licensed in California, and he did not have proof that they were licensed nurses. A review of facility’s policy and procedure titled “Entries into the Clinical Record” revised 4/2020, indicated “Home health personnel providing direct patient care and supervision functions have authority to make entries into the clinical record. Amendments, corrections or late entries within an electronic health record must: distinctly identify any amendment, correction, or late entry.”