Every finding on record at Unison Health Services, Inc

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey conducted on 10/11/2022 to 10/14/2022. Federal Intake Number: 102723 Representing the California Department of Public Health: Surveyor ID #22303, Health Facilities Evaluator Nurse Surveyor ID #44916, Health Facilities Evaluator Nurse Unduplicated Census: 802 Sample Size: 17 Home Visits: 7

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to ensure patient rights and responsibilities information were provided in a language easily understood by one of 17 patients (Patient10). Patient 10 spoke other language besides English. Patient 10 was provided a Patient Handbook and an informed consent in a language not preferred and understood by the patient. This failure had the potential to result in the patient/family member not fully understand their rights and responsibilities, and other pertinent information contained in the Patient Handbook. A review of Patient 10’s clinical record indicated a start of care date (SOC) of 12/15/2023 with a primary diagnosis of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar or glucose; with type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin) and diabetic neuropathy (a type of nerve damage that can occur when a person has diabetes. High blood sugar (glucose) can injure nerves throughout the body and sciatica-Pain originates in the spine and radiates down the back of the leg. Sciatica typically affects only one side of the body). During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 12/20/2023, at 11 a.m., Patient 10 was observed walking with assistive device, alert, and oriented and communicated with LVN 1 and Family Member 1 (FM 1) solely in Spanish. During a review of Patient 10’s home folder provided by the home health agency (HHA), it was noted the Patient Handbook was written entirely in English. During an interview with Family Member 1 (FM 1) on 12/22/2023, at 11:30 a.m., FM 1 stated Patient 2 only spoke Spanish. FM 1 stated he remembered Patient 10 signed consents written in English language during admission. According to both FM 1 and Patient 10, both did not understand what was in the consent or the Patient Handbook. During an interview with the Director of Nursing (DON) on 12/18/2023, at 10:30 a.m., the DON stated the admissions nurse could have provided the consents and Handbook in Spanish to Patient 10. It’s better for the patient because that’s the language that the patient understands.” A review of the agency’s policy, titled “Informed Consent/Refusal of Treatment,” revised April 2018, indicated that upon admission and throughout the course of care, the patient, family/caregiver and/or patient representative would be given information in an understandable language, to make informed decisions regarding the care being provided.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to document an alleged complaint of patient neglect (an act or failure to act which presents an imminent risk of serious harm), and the resolution (decision) of the complaint for one out of 17 sampled patients (Patient 8). This deficient practice had the potential for the patient's complaint or grievances presented to the HHA will not be addressed and resolved promptly and could affect the quality of care and wellbeing of the patient. On 12/19/2023, at 1 p.m., a complaint validation survey was conducted at the home health agency (HHA) regarding alleged patient neglect indicating LVN 1 did not perform Patient 8's wound care treatment during LVN 1's home visit on 12/22/2023. As a result, Patient 17 was transported to the emergency room on 12/22/23, for further evaluation and treatment of the wounds. A review of Patient 8's Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 8 on 8/17/23, with a diagnosis that included fracture at superior rim of left pelvis. During a review of Patient 8's Initial Comprehensive Assessment, dated 8/17/2023, indicated under the Integumentary Section the patient had a Stage III mid back pressure injury with wound measurements of 6 cm (centimeters) in length by 2 cm in width without drainage and a Stage three left heel pressure injury with wound measurements of 4.5 cm in length by 2.8 cm in width without drainage. A wound care was provided by the visiting nurse for both wound sites as follows: cleansed with Normal Saline, patted dry, applied Hydrogel and covered with 4x4 dressing. During a review of Patient 8's Home Health Certification and Plan of Care (POC) for certification period from 8/17/2023 to 10/15/2023, indicated the frequency of visits of SN (skilled Nurse) to one visit per week for one week, twice a week for eight weeks, to provide wound care treatment at Stage III mid back and left heel as follows: to cleanse with Normal Saline, pat dry, apply Hydrogel ointment and covered with 4x4 dressing daily. A review of Patient 8's Communication Note dated 8/22/2023, indicated FM 1 (family member) called the HHA (home health agency) and reported that LVN 1 came in on 8/22/2023 but did not clean the wounds nor provide wound treatment. FM 1 stated he was very anxious and upset and kept saying that LVN 1 was neglecting the patient. During an interview on 12/19/2023, at 2 p.m., with the DPCS (director of patient care services), she stated she was aware that FM 1 filed a grievance regarding an alleged neglect by LVN 1 for not providing wound treatment as ordered during her visit for Patient 8. The DPCS further stated the agency failed to document the complaint in their grievance book in order to find a resolution to the issue as per their agency’s policy. During a review of the agency’s undated policy and procedure titled, “Grievances and Complaints”, indicated at the time of admission, and as needed, patient/client and/or family/caregiver shall be informed of their rights to voice grievances regarding treatment or care, lack of respect of property, or recommend changes in policy, staff, or service/care without restraint, interference, coercion, discrimination, or reprisal. Grievances received from a patient/client and/or family/caregiver will be promptly reported to Office Leadership/Designee for assessment determination.

Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This ELEMENT is not met as evidenced by: Based on interview, and record review, the home health agency failed to complete the comprehensive assessment (the required in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for one of 17 patients (Patients 10), in order to determine eligibility to receive home health benefit, including homebound status. This deficient practice resulted for the patient being provided home health services whose eligibility status was not determined in coordination with the patient's attending physician in order to receive the Medicare home health benefits. A review of Patient 10’s clinical record indicated a start of care date (SOC) of 12/15/2023 with a primary diagnosis of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar or glucose; with type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin) and diabetic neuropathy (a type of nerve damage that can occur when a person has diabetes. High blood sugar (glucose) can injure nerves throughout the body and sciatica (Pain originates in the spine and radiates down the back of the leg. Sciatica typically affects only one side of the body). During a joint home visit conducted at Patient 10's residence with the licensed vocational nurse 1 (LVN 1) on 12/20/2023, at 11 a.m., Patient 10 was observed alert, oriented to name, person, place and time. Walked independently without assistive device. Not in any respiratory distress. Speaks fluent Spanish only. During an interview with Patient 10 and her husband stated that Patient 10 received hospice care before. Patient 10 stated that she received a call from a person identified self from "Medi-cal" and asked if she was dying or had 6 months to live. Patient 10 stated, "No" I am not dying and that she only has high blood pressure, diabetes and sciatica pain. Patient 10 also stated that the person who called her will discharge her from hospice and will be transferred to home health. Patient 10 stated that she was not able to get the name of the person who called her. Patient 10 stated the nurse from the home health agency came and had her sign papers. When asked when the last time she saw the referring doctor listed on the plan of care, Patient 10 stated she had not seen any doctor from the hospice agency. When asked if she went to the clinic of the doctor who referred her to the home health agency, Patient 10 stated in Spanish " No I don't know who that doctor was". During an interview with the Director of Nursing (DON) on 12/22/2023, at 10:30 a.m., DON stated that Patient 10 was referred from a hospice agency. DON stated they received the order from the nurse practitioner (NP) who was working in the same medical group. When asked who the referring doctor was for Patient 10, DON stated it was the doctor from the hospice agency. DON stated that the doctor of the hospice agency will also be the attending doctor for Patient 10. A phone call attempt on 12/22/2023, at 12:12 p.m., to the attending and referring doctor for Patient 10. The DON from another hospice facility called back and confirmed that Patient 10 was a former patient of theirs and was discharged from their services. When asked if the doctor who referred Patient 10 to this home health agency will continue to follow up Patient 10, she stated " No, he is our medical director and he will not continue to follow up on her care after discharge." During an interview with the DON on 12/22/2023, at 1:23 p.m., DON stated that it was their policy for the patient to be seen by their referring doctor first before admission to home health. DON stated that the field staff should have called the agency first when they encounter problems or issues in the field. DON further stated that before they even admitted Patient 10, they should have confirmed who was the referring doctor and which doctor will follow up with the patient first before admission. A review of Patient 10's "Home health Certification and Plan of Care" for the period of 12/15/2023 to 2/12/2023 indicated orders and treatments that included skilled nurse (SN) services once a week for one week and twice a week for 8 weeks (20 authorized visits from health plan, will request for more). SN was to perform assessment /observation of each body system cardiovascular, endocrine, respiratory, gastrointestinal, genito-urinary, integumentary, musculoskeletal, neurosensory, lymphatic system, mental/emotional status. SN was to take vital signs (blood pressure/ temperature/ heart rate/ respiration), pulse oximetry (device that measures saturation of oxygen in the blood), monitor weight and edema (swelling caused by too much fluid in the body's tissues) weekly, assess pain level using pain scale, implement pain relief measures and evaluate its effectiveness, and to instruct patient and PCG to check the blood sugar daily. The POC included for the SN to instruct patient and caregiver as follows: -Disease process of DM type 2, sciatica, pain management, infection control management, prevention of disease exacerbation and potential complications and importance of prompt reporting to MD, measures to recognize endocrine and cardiac dysfunction. SN to instruct the patient/caregiver on diabetes is a common disorder in which the body cannot properly use the carbohydrates (starches and simple sugars), fats and proteins in foods. Testing blood sugar regularly, eating well and exercising daily are all important aspects of diabetes management. Notify physician for random blood sugar greater than(>) 300 or less than() 250 or less than() 3 lbs. or less than() 100 or less than () 26 or less than () 160 or less than()90 or less than () 101 or less than (<) 96. Pain scale of 7/10 and greater not relieved with pain medications. There was no documented evidence the agency conducted a comprehensive assessment for Patient 10 in coordination with the attending or referring physician. There was no documented evidence the attending physician participated in the development of the POC for certification period of 12/15/2023 to 2/12/2023. There was no documented evidence Patient 10's admission for home health was accurately assessed to determine patient's eligibility for Medicare home health benefits. A review of the HHA's policy titled " Physician Participation in the Plan of Care" revised April 2018 indicated to provide guidelines for the physician's participation in home health services. A physician will direct the care of every home health patient admitted for service. The attending physician will certify that medical, skilled, rehabilitation, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare. The attending physician (or other authorized licensed independent practitioner) will participate in the care planning process by reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice. When services are provided on the basis of a physician's verbal orders, a registered nurse, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law shall document the orders in the patient's clinical record, and sign, date, and time the orders. Orders are reviewed for appropriateness and accuracy before care, treatment, and services are provided. The organization may assist the physician in determining medical necessity and formulating an appropriate plan of care, if requested by the physician.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to maintain an accurate, and current medication profiles for 2 of 17 sampled patients (Patients 9 and 10). This failure had placed the patients at risk for medication errors and adverse drug reactions. 1. A review of Patient 9’s clinical record indicated a start of care date of 12/8/2023 with a primary diagnosis of puncture wound right upper arm fracture (upper arm bone id broken) and type 2 diabetes mellitus with diabetic neuropathy (a type of nerve damage that can occur when a person has diabetes). SN frequency once a week for one week and twice a week for eight weeks to assess medication compliance, knowledge, and medication effectiveness. SN to educate patient on medication usage, route, dosage, side effects, interactions and administration. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 12/21/2023 at 10:45 a.m., Patient 9 was observed walking with assistance from the daughter, alert and oriented to name, place, person and time. Patient 9 was moaning in pain at the time of home visit, extremely guarded but was not in any respiratory distress noted. During the medication review with the LVN 1 at the same date and time, the following medication discrepancies were noted: Glimepiride 4mg 1 daily was changed to twice daily Carvedilol 25mg daily was changed to 12.5mg twice daily Missing medications on the medication profile were: 1. Clonidine 0.1 mg 1 tab as needed for High Blood pressure 2. Atorvastatin 80 mg daily for cholesterol 3. Gabapentin 100 mg three times daily for neuropathy 4. Hydroxyzine 25 mg as needed for itching 5. Jardiance 10 mg daily for diabetes 6. Amlodipine 2.5 mg daily for high blood pressure 7. Ondansentron 4 mg 1-2 mg three times daily for three days for nausea 8. Fish Oil 1000 mg daily for supplement 9. Tramadol 50 mg every 8 hours was changed to every 4 hours as needed for pain 10. New order for oxycontin was mentioned but she does not know the dose and frequency yet. 11. Vit. B12 1000 mcg (micrograms-unit of measurement) daily as supplement 12. Urocholine 25 mg every 6 hours for urination 13. Vit C 500 mg daily as supplement During an interview with Patient 9 on 12/21/2023, Patient 9 stated she has a lot of medications, and this is her first time under home health services and she did not know that she had to give the complete medication list to the nurse who admitted her at the time. During an interview with the Director of Nursing (DON on 12/22/2023 at 10:30 a.m., DON stated that the nurse should review patient's medications and compare it with the bottles at home and update the medication profile for any changes during the home visit and update the plan of care. 2. A review of Patient 10’s clinical record indicated a start of care date (SOC) of 12/15/2023 with a primary diagnosis of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar or glucose; with type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin) and diabetic neuropathy (a type of nerve damage that can occur when a person has diabetes. High blood sugar (glucose) can injure nerves throughout the body and sciatica (Pain originates in the spine and radiates down the back of the leg. Sciatica typically affects only one side of the body). Skilled nursing (SN) frequency once a week for one week and twice a week for eight weeks to assess medication compliance, knowledge, and medication effectiveness. SN to educate patient on medication usage, route, dosage, side effects, interactions and administration. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 12/20/2023, at 11 a.m., Patient 10 was observed walking with assistive device, alert and oriented to name, place, person and time. Walking without assistive device and was not in any respiratory distress noted. During the medication review for Patient 10 at the same date and time, the following medication discrepancies were noted: There were only 2 bottles of medications found at the patient's home. Patient 10 stated these were new medications delivered to her. Metformin 1000 milligrams (mg- a unit of measurement) 1 tablet twice daily for diabetes and Lisinopril 20 mg-hydrochlorothiazide 12.5 mg 1 tablet daily for high blood pressure. Amlodipine Besylate 10 mg 1 tablet daily for high blood pressure was not at the patient's home. There were 4 medications listed in the medication profile that needs to be picked up from the pharmacy. During an interview with LVN 1 stated that it is important to verify and list all the medications that the patient takes during the home visit to know how they can update the plan of care every visit. A review of the HHA's policy titled Identification of Medication for Administration" revised January 2018 indicated that to provide general guidelines for the safe administration of medications in the home. Orders for the administration of patient medications must be given by a physician (or other authorized licensed independent practitioner) and will include patient name, patient identifier, the name of the medication, dosage, dilution, route, frequency of administration, and rate of infusion, if applicable. Orders for anaphylaxis, laboratory work and indications for drug use will be obtained when appropriate. Correct identification of the patient is also critical for patient safety with medication administration. All clinicians will use two identifies to ensure the patient is the correct patient for medication administration, blood draws, and other treatments. Medications will be properly labeled with the patient's name, an additional patient identifier, name of drug, dosage, diluent, date of preparation, expiration date, initials of preparer, and any special instructions, as applicable. A complete list of the patient's medications is communicated to the next provider of service when a patient is transferred or referred to another setting, service, practitioner, or level of care within or outside of the organization. A review of the HHA's policy titled "Medication Profile" revised November 2018, indicated that 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.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to coordinate care and delivery of services from the skilled nursing facility (SNF) in reference to the severity of the patient's wounds for one of 17 sampled patients ( Patient 8). This deficient practice resulted in Patient 8's wounds not identified for immediate care, treatment, and intervention leading to the patient's admission to the acute hospital emergency room. A review of Patient 8's clinical record indicated a start of care (SOC) date of 8/17/2023, with a diagnoses of fracture of the rim of left pubis (generally the result of a direct blow, often in elderly patients, and are the result of minimal traumatic force) and hypertensive heart disease (a constellation of changes in the left ventricle, left atrium, and coronary arteries as a result of chronic blood pressure elevation). A review of Patient 8's Plan of Care (POC) for the certification period of 8/17/2023 to 10/15/2023, included an order for Skilled Nursing (SN) to visit once a week for one week and twice a week for 8 weeks. The SN was to perform wound care treatment to: Wound #1: Mid back; Pressure ulcer Stage 3; measuring 6.0 cm x 2.0 cm x O cm. with normal saline, pad dry, apply hydrogel, cover with 4x4 gauze daily. Left Heel; Pressure ulcer Stage 3; measuring 4.5.0 cm x 2.0 cm x O cm. SN to perform wound care as follows: cleanse with normal saline, pad dry, apply hydrogel, cover with 4x4 gauze daily. Patient/caregiver was able and willing to perform wound care safely during non-SN visits as validated by skilled nurse. The POC further indicated for SN to perform on every visit Vital signs: blood pressure/ temperature/ heart rate/ respiration/pulse oximetry wound monitoring weekly. SN to demonstrate to patient/caregiver measures for infection prevention control such as proper hand washing and proper disposal of soaked dressing to infectious waste. SN to assess medication compliance, knowledge, and medication effectiveness. SN to educate patient on medication usage, route, dosage, side effects, interactions and administration. Occupational Therapy evaluation and treatment (5 authorized visits from health plan) and Speech Therapy evaluation and treatment (5 authorized visits form health plan). A review of Patient 8's POC included "Goals and Outcomes" for the same period indicated Patient will remain in the home setting & not require unplanned medical care, emergent care or hospitalization for complications of disease exacerbation in 9 weeks (Goal Term: long, Target Date: 10/15/23) Patient/Caregiver will verbalize understanding and will call 911/MD within 4 weeks if heart attack symptoms arises (Goal Term: long, Target Date: 9/15/23) During an interview with the Patient 8's family member on 12/21/2023 at 12:28 p.m., stated that Patient 8 fell at home and was sent to the hospital last June 2023 for her right hip surgery. Patient 8 was discharged to a skilled nursing facility (SNF) for rehab in 7/22/2023 and stayed there till 8/14/2023. Patient was discharged to home when the SNF told him that they cannot care for the patient and will be discharged to the care of a home health agency. Patient 8's family member stated the SNF did not inform him of the severity of her wounds and filed a complaint against them. Patient 8's family member stated the SNF told him that she only had tiny wounds that the home health agency can take care of. Family member further stated that two nurses came from the HHA on 8/17/2023 and 8/22/2023, but he was not satisfied with the wound care provided. Family member stated that when the 2nd nurse took pictures of the wound, he thought it was very bad and was afraid to have infection. Family member requested something to be done but the nurses kept on telling him they were waiting for authorization from the patient's insurance for wound care supplies. Family member stated no one explained to him what it meant and why they have to wait for authorization Family member stated when the nurse left, he called the patient's insurance and doctor to notify them of what happened. Family member stated he received a phone call from the patient's doctor and told him to call 911 and bring the patient to the nearest hospital for possible infection. Family member stated patient received a dose of intravenous antibiotics and was discharged to another rehab facility and then discharged to home under another HHA. During a phone interview with Licensed Vocational Nurse 2 (LVN 2) on 12/22/2023 at 2:34 p.m., LVN 2 stated that “Technically I would try to explain my side that, but the family member kept on insisting that this should’ve been done when things like this happens, I would tell them I will call my case manager and call the doctor.” LVN 2 stated “I was caught off-guard about this patient because on my end I would ask them about their health plan. The family member was very upset at that time.” LVN 2 stated “I should have spent more time with the son explaining that the HHA was still getting authorization for the approval of the supplies.” During a concurrent interview with the Director of Nursing (DON) at the same date and time while on the call with the LVN 2, DON stated as a field staff, the staff should have called the agency while she was there and informed us of the situation and the concern should have been dealt with the patient's family properly. A review of the HHA's policy titled " Care Coordination" revised April 2018 indicated that Care coordination will include, but not be limited to: Clearly outlining each clinician's responsibilities to avoid duplication of services, Developing complementary actions and goals, Regularly occurring telephone or e-mail communication among team members, Planned face-to-face conferences, Timely documentation of coordination of care activities, Appropriate involvement of the patient and caregivers, Limiting the number of personnel assigned to a case, when possible, Proper communication upon "hand-off' of patient, including the opportunity for questions between the giver and receiver of patient information. Coordinate communication with all physicians involved in the plan of care. Integrate orders from all physicians involved in the plan of care so that all services and interventions are coordinated. Integration of 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. Coordination of care delivery to meet the patient's needs, and involve the patient, representative, and caregivers, as appropriate, in the coordination of care activities. Ensuring that each patient, and their caregiver(s), where applicable, receive ongoing education and training provided by the organization regarding the care and services identified in the plan of care. The organization shall provide training, as necessary, to ensure a timely discharge. All organization personnel involved in patient care, including those providing contracted services, will have access to the plan of care and all other relevant patient information to ensure coordination and continuity of care. All personnel will be knowledgeable regarding patient needs, goals of care and services.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to perform hand hygiene after removing pair of gloves used to remove soiled dressing, and prior to providing wound care for two of 17 sample patients (Patients 1 and 2). This deficient practice placed the patient at a potential risk in the delay in wound healing or cause a wound infection. a. A review of Patient 1's Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 1 on 12/3/23, with a diagnosis that included left hip punctured wound without foreign body. During a review of Patient 1's Home Health Certification and Plan of Care (POC) for certification period from 12/3/2023 to 1/31/2023, indicated the frequency of visits of SN (skilled Nurse) to three times a week for one week, two times a week for eight weeks, to provide wound care treatment at Stage II right buttocks as follows: to cleanse with Normal Saline, pat dry, apply Hydrogel ointment and covered with 4x4 dressing daily. On 12/20/23, at 12 p.m., during a joint home visit with Licensed Vocational Nurse (LVN) 2, Patient 1 was observed lying in a bed with dressing on his right buttocks. During a wound care observation on 12/20/2023, at 12:10 p.m., LVN 2 was observed washing his hands, donned (put on) new gloves and removed the old dressing on the right buttocks. LVN 2 cleansed the Stage II pressure ulcer with 4 x 4 gauze wet with normal saline, patted dry and repeated the procedure two times. LVN 2 removed the gloves that touched the open wound. LVN 2 donned a new pair of gloves, applied Hydrogel ointment and covered with gauze. LVN 2 did not wash hands or performed hand hygiene prior to donning new pair of gloves. b. A review of Patient 2's Face Sheet (admission record), the Face Sheet indicated the agency admitted Patient 2 on 12/13/2023, with a diagnosis that included subdural hematoma. During a review of Patient 2's Home Health Certification and Plan of Care (POC) for certification period from 12/13/2023 to 2/10/2024, indicated the frequency of visits of SN (skilled Nurse) to two times a week for one week, two times a week for eight weeks, to provide wound care treatment at surgical site on top of head as follows: to cleanse with Normal Saline, pat dry, apply Betadine ointment and covered with 4x4 dressing daily. On 12/20/2023, at 1:30 p.m., during a joint home visit with Licensed Vocational Nurse (LVN) 2, Patient 21 was observed sitting on a couch at the family room. Patient 2 had a dressing on top part of her head. During a wound care observation on 12/20/2023, at 1:50 p.m., LVN 2 was observed washing his hands, donned new gloves and removed the old dressing on top part of patient's head. LVN 2 cleansed the surgical incision wound with 4x4 gauze wet with normal saline and repeated the procedure three times. LVN 2 took off the gloves that touched the open wound, donned a new pair of gloves and applied Betadine ointment. LVN 2 did not wash hands or performed hand hygiene prior to donning new pair of gloves. On 12/20/2023, at 2 p.m., during an interview with LVN 2, he stated he forgot to wash or sanitize his hands after removing his soiled gloves after cleaning the open wounds for both Patient 1 and 2. On 12/22/2023, at 2 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated, " LVN 2 should have washed or sanitized the hands after removing the gloves that touched the soiled dressing." A review of the agency's undated policy of "Hand Hygiene ", indicated a hand decontamination with an alcohol-based hand rub should be used after removing gloves.

The following reflects the findings of the California Department of Public Health during a Complaint Validation survey from 8/16/2023 to 8/18/2023. Representing the California Department of Public Health: Health Facilities Evaluator Nurse: Surveyor ID: 45783 Health Facilities Evaluator Nurse: Surveyor ID: 44186 Active Patients: 853 Unduplicated Admissions: 9956 Sample Size: 18 Home Visits: 7 Closed Record Reviews: 5

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to provide and/or obtain information regarding the advance directive (a written statement of a person's wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a doctor) from one of 18 sampled patients (Patient 8) or their representative. This failure resulted in the HHA staff to not be aware of the patients’ final wishes, which can cause confusion if information is needed in a time of crisis,which can go against the patients last wishes and rights. Findings: A review of Patient 8's clinical record indicated a start of care date of 08/08/2023, with diagnoses that included hypertensive heart disease (a long-term condition that develops over many years in people who have high blood pressure), type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]) with hypoglycemia (low blood sugar), and malignant neoplasm of the prostate (prostate cancer). A review of Patient 8’s Outcome and Assessment Information Set (OASIS, is the patient-specific, standardized assessment used in Medicare for home health care to plan care, determine reimbursement, and measure quality) indicated a start of care, date of 08/08/2023. The box in the section for “Advanced Directives” was checked as “No." The box which indicated whether the patient was provided written and verbal information on Advance Directives, was checked as “No.” On 8/18/2023 at 4:45 p.m., during a concurrent interview and record review with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated the admitting nurse did not ask Patient 8 or his representative about his last wishes. DPCSD stated all patients admitted to the agency should have been provided information on Advance Directives and this should be documented in the patient’s clinical record. A review of the agency’s policy and procedure titled, “Advance Directives,” revised January 2018, indicated upon admission, the clinician will provide information regarding a patient’s right to make decisions concerning health care, which include the right to accept or refuse medical or surgical treatment, even if the treatment is life-sustaining, the right to execute Advance Directives, and applicable organization policies. The clinician will document in the clinical record that the information was provided and record all discussions concerning Advance Directives. A review of the agency’s policy and procedure titled, “Rights/Responsibilities,” revised April 2018, indicated each patient will be an active, informed participant in his/her plan of care. The patient will be informed verbally or in writing during the initial evaluation visit, in advance of furnishing care to the patient, the right to formulate Advance Directives and the organization’s policy on the withholding of resuscitative services and the withdrawal of life-sustaining treatment and to lodge complaints concerning the implementation of the advance directive requirements.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to ensure that one of eighteen sampled patients (Patient 2) was provided with informed consent and provided with a Patient Handbook in a language the patient understood. This failure had the potential to result in Patient 1 not understanding her rights and responsibilities, as well as other important information contained in the Patient Handbook, such as how to file a complaint or grievances. A review of Patient 2’s clinical record indicated a start of care date (SOC) of 8/5/2023 with a primary diagnosis of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar or glucose; with type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin) and diabetic neuropathy (a type of nerve damage that can occur when a person has diabetes. High blood sugar (glucose) can injure nerves throughout the body. Diabetic neuropathy most often damages nerves in the legs and feet). During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/16/2023 at 2:30 p.m., Patient 2 was observed ambulating, alert and oriented and communicated with LVN 1 and Family Member 1 (FM 1) solely in Spanish. Upon reviewing Patient 2’s home folder provided by the HHA, it was noted the Patient Handbook was written entirely in Spanish. During an interview with Family Member 1 (FM 1) on 8/16/2023 at 4 p.m., FM 1 stated Patient 2 only spoke Spanish. FM 1 stated she remembered Patient 2 signed consents upon admission, all of which were in English. According to FM 1, Patient 2 did not understand what was in the consent or the Patient Handbook. FM 1 stated she had to translate what was written in the consent to Patient 2. During an interview with the Director of Patient Care Services (DPCSD) on 8/18/2023 at 12 p.m., the DPCSD stated the HHA did have the consent and Patient Handbook available in Spanish. The DPCSD provided a sample of the consent and Patient Handbook in Spanish for the surveyor. The DPCSD stated, “We could have provided the consent and handbook in Spanish. It’s better for the patient because that’s the language she understands.” A review of the agency’s policy, titled “Informed Consent/Refusal of Treatment,” revised April 2018, indicated that upon admission and throughout the course of care, the patient, family/caregiver and/or patient representative would be given information in an understandable language, to make informed decisions regarding the care being provided.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to maintain an accurate, current medication profile for five of 18 sampled patients (Patient 2, Patient 3, Patient 4, Patient 10, and Patient 11). This deficient practice had the potential to place the patient at risk for medication errors and adverse drug reactions. d. A review of Patient 10's clinical record indicated a start of care date (SOC) of 8/02/2023, with diagnoses which included cellulitis (a common skin infection caused by bacteria) of left lower limb, blister (an area of skin covered by a raised, fluid-filled bubble) left foot, and chronic kidney disease (means your kidneys are damaged and can't filter blood the way they should). A review of Patient 10’s Home Health Certification and Plan of Care (POC) for the certification period from 08/02/2023 to 09/30/2023, included an order for the Skilled nurse (SN) to visit the patient two times a week for nine weeks to perform assessment and observation of each body system, pain monitoring, perform vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), and to reconcile medications with the physician via medication reconciliation On 08/17/2023, at 12:10 p.m., a joint home visit with Licensed Vocational Nurse (LVN 3) was conducted at Patient 10’s residence. Patient 10 was observed awake, alert and oriented (to person, place, and time), accompanied by her daughter (FM 3). On 8/17/2023, at 12:30 p.m., during a review of Patient 10’s current medication, Melatonin oral 10 milligrams (mg) 1 capsule by mouth once a day at nighttime was not found. However, Patient 10’s current medication record provided by the HHA indicated patient was taking the medication. During a concurrent interview with FM 3, she stated Patient 10 was not taking Melatonin anymore for several months. e. A review of Patient 11's clinical record indicated a start of care date of 07/28/2023, with diagnoses which included type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]), epilepsy (a disorder of the brain characterized by repeated seizures), and hypertensive heart disease (a long-term condition that develops over many years in people who have high blood pressure). A review of Patient 11’s Home Health Certification and POC for the certification period from 07/28/2023 to 09/25/2023, included an order for the skilled nurse to visit the patient once a week for 1 week, then twice a week for 1 week, and then once a week for 7 weeks to perform assessment and observation of each body system, perform vital signs, and assess for medication compliance, knowledge, and medication effectiveness. On 08/18/2023, at 10:50 a.m., a joint home visit with Licensed Vocational Nurse (LVN 4) was conducted at Patient 11’s residence. Patient 11 was observed awake, alert and oriented x 3 (person, place, and time), and ambulatory. On 8/18/2023, at 11:10 p.m., during a review of Patient 11’s current medication, there was a bottle of Sertraline Hydrochloride (used to treat depression) 100 mg 1 tablet by mouth once daily at bedtime. However, Patient 11’s current medication record provided by the HHA indicated patient was taking Sertraline Hydrochloride 50 mg 1 tablet by mouth at bedtime. During a concurrent interview with Patient 11, she stated her attending physician increased her Sertraline dose from 50 mg to 100 mg once daily at bedtime and she was taking 100 mg dose since last year. On 8/18/2023 at 04:45 p.m., during an interview with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated nursing staff need to review patient’s current medication on every nurse visit and update the medication profile in the patient’s clinical record. A review of the agency’s policy and procedure titled, “Medication Profile”, revised November 2018, 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. a. A review of Patient 2’s clinical record indicated a start of care date (SOC) of 8/5/2023 with a primary diagnosis of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar or glucose; with type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin). Diabetic neuropathy is a type of nerve damage that can occur when a person has diabetes. High blood sugar (glucose) can injure nerves throughout the body. Diabetic neuropathy most often damages nerves in the legs and feet. A review of Patient 2’s “Home Health Certification and Plan of Care,” for the certification period of 8/5/2023 to 10/3/2023, indicated the Skilled Nurse (SN) was to assess medication compliance, knowledge, and medication effectiveness. SN was also to educate patient on medication usage, route, dosage, side effects, interactions, and administration. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/16/2023, at 3:50 p.m., a medication review was performed. Upon medication review, the surveyor noted that Jardiance Oral (a medication used to control blood glucose levels in people with type 2 diabetes) 25 Mg 1 tablet daily was not available at the patient’s house. The surveyor also confirmed with Patient 2 that she was taking Losartan Potassium (a prescription to treat high blood pressure, diabetic nephropathy, and stroke risk) 50 Mg 1 tablet daily as indicated on the medication label. The medication profile listed Losartan Potassium 100 Mg 1 tablet daily. During interview with Family Member 1 (FM 1) on 8/18/2023 at 3:50 p.m., Jardiance Oral 25 Mg was discontinued not long after Patient 2 started taking it, which was sometime in June 2023. FM 1 stated Patient 2 experienced severe side effects from Jardiance, such as nausea, lethargy, and restlessness. FM 1 stated that the physician subsequently put Patient 2 on Rybelsus (a medication to treat type 2 diabetes) 3 Mg once daily. FM 1 also stated that Patient 2 had been taking Losartan Potassium 50 Mg one tablet daily “for a while.” During interview with LVN 1 on 8/16/2023 at 4 p.m., LVN 1 stated that the visiting nurse needed to check patient’s medication with every visit. LVN 1 stated, “If there’s discrepancy between the medication profile and the actual medications, the nurse needs to call the office and let them know. Someone at the office will update the medication profile.” LVN 1 stated that it was important to keep patient’s medication profile current so that the patient would not take a medication that has been discontinued, staff nurse would be able to provide teaching or monitor side effects of medications. b. A review of Patient 3’s clinical record indicated a start of care date (SOC) of 8/9/2023 with a primary diagnosis of puncture wound (a small, rounded wound caused by long, pointy objects such as a nail, needle, or ice pick) without foreign body, right hip. A review of Patient 3’s “Home Health Certification and Plan of Care,” for the certification period of 8/9/2023 to 10/7/2023, indicated the Skilled Nurse (SN) was to assess medication compliance, knowledge, and medication effectiveness. SN was also to educate patient on medication usage, route, dosage, side effects, interactions, and administration. During a joint home visit with Registered Nurse 1 (RN 1) on 8/17/2023, at 10:30 a.m., observed Patient 3 sitting on the couch, alert and oriented. During the joint home visit, at 11 a.m., a medication review was performed. Upon medication review, the surveyor confirmed with Patient 3 that she was taking Celebrex 100 Mg 1 capsule twice a day as indicated on the medication label. The med profile listed Celebrex oral 200 Mg, 1 capsule by mouth, once daily. The surveyor noted two medications in Patient 3’s medication profile were not available at the patient’s home: - Lovenox (an anticoagulant (blood thinner) used to prevent blood clots) injection 30 Mg/0.3 ml, inject under the skin, once daily. - Halcion (a medication used to treat a certain sleep problem (insomnia)) oral 0.25 Mg, 1 tablet by mouth as needed. During interview with Patient 3 on 8/17/2023 at 11:10 a.m., Patient 3 stated that she had only had Lovenox injection while she was in the hospital. Patient 3 stated, “My doctor said it can only be administered by a nurse because it’s a high risk medication. I’ve never had it at home.” Patient 3 also stated that she had never taken Halcion. Patient 3 said she was not sure why Halcion was in her medication list. During interview with RN 1 on 8/17/2023 at 11:15 a.m., RN 1 stated, “The Registered Nurse (RN) or Licensed Vocational Nurse (LVN) who visits the patient should check all of patient’s medications on every visit and call the office if there is a new medication, or discontinued medication, or change in dose. Patient’s medication profile needs to be updated. The purpose is to make sure that patient takes the prescribed medications, to see if patient is compliant or not.” RN 1 also stated that if medication profile was not current, it could affect patient safety, such as patient might take discontinued medications that she no longer needed. c. A review of Patient 4’s clinical record indicated a start of care date (SOC) of 7/18/2023 with a primary diagnosis of puncture wound (a small, rounded wound caused by long, pointy objects such as a nail, needle, or ice pick) without foreign body, other part head. A review of Patient 4’s “Home Health Certification and Plan of Care,” for the certification period of 7/18/2023 to 9/15/2023, indicated the Skilled Nurse (SN) was to assess medication compliance, knowledge, and medication effectiveness. SN was also to educate patient on medication usage, route, dosage, side effects, interactions, and administration. During a joint home visit with Registered Nurse 1 (RN 1) on 8/17/2023, at 11:50 a.m., observed Patient 4 ambulating. Observed Patient 4 alert and oriented. During the joint home visit, at 12:10 p.m., a medication review was performed. Upon medication review, the surveyor noted that Patient 4 had Levothyroxine (a medicine used to treat an underactive thyroid gland (hypothyroidism)) 50 Mg tablet, with the instruction on the label indicating that Patient 4 should take 1 tablet a day with breakfast. Confirmed with Patient 4 that he was taking Levothyroxine 50 Mg as instructed on the label. Levothyroxine 50 Mg tablet was not listed in Patient 4’s medication profile. During interview with RN 1 on 8/17/2023 at 12:25 p.m., RN 1 stated he had never seen Patient 4 before, so he did not know if Patient 4 was already on Levothyroxine 50 Mg upon admission. RN 1 stated that Patient 4 received weekly visit from the HHA. Per RN 1, “Whoever visits the patient needs to inform the office that he is taking a medication that’s not listed on the medication profile. We need to keep his medication profile current.” During interview with the Director of Patient Care Services Designee (DPCSD) on 8/18/2023 at 12:30 p.m., the DPCSD stated that the nurse had to check if patient had any change in medications on every visit. The nurse then would have to document and call the office to report the changes so that the supervisor could update the medication profile, generate a verbal order, and fax it to the primary care provider (PCP). The DPCSD also stated, “Patient needs to have a current medication profile so that we know the medications taken by patient, if there’s any interaction, also for care coordination between PCP, specialist, and the home health agency itself.” A review of the HHA’s policy, titled “Medication Profile,” revised November 2018, indicated that: - 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. - 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.

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 Patient 9's blood sugar level was monitored and documented in accordance with the plan of care (POC) for one of 18 sampled patients (Patient 9). This deficient practice resulted in Patient 9 not receiving the quality of care and services identified in the POC. Findings: A review of Patient 9's clinical record indicated a start of care date of 07/12/2023, with a diagnoses which included hypertensive heart disease (a long-term condition that develops over many years in people who have high blood pressure), type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]), and lymphedema (swelling in an arm or leg caused by a lymphatic system blockage). A review of Patient 9’s Home Health Certification and Plan of Care (POC) for the certification period from 07/12/2023 to 09/09/2023, included an order for the skilled nurse to visit the patient two times a week for one week, then three times a week for seven weeks, and then four times a week for one week, to perform assessment and observation of each body system, assess for medication compliance, knowledge, and medication effectiveness, perform vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), and perform blood sugar monitoring A review of Patient 9's Skilled Nursing Visit Notes for the certification period of 07/12/2023 to 09/09/2023, indicated that the blood sugar was not monitored and documented on 07/17/2023, 07/20/2023, 07/26/23 and 08/01/2023. On 8/18/2023 at 04:45 p.m., during a concurrent interview and record review with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated that the blood sugar for Patient 9 should be checked during each nurse visit and documented in accordance with the plan of care. The DPCSD stated and acknowledged the finding. A review of the agency’s policy and procedure titled, “Care Planning Process”, revised January 2018, indicated a written plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. Based on the assessment and conclusions, the plan of care will include, but not be limited to patient specific interventions and education, and all patient care orders from all physicians involved in the plan of care, including verbal orders.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide a copy of a recent, updated plan of care for one of eighteen sampled patients (Patient 3). This deficient practice had the potential to cause the patient and/or the family/caregiver to not know the treatment plan, not knowing the services provided by the HHA, and not being an active participant in their care planning process. A review of Patient 3’s clinical record indicated a start of care date (SOC) of 8/9/2023 with a primary diagnosis of puncture wound (a small, rounded wound caused by long, pointy objects such as a nail, needle, or ice pick) without foreign body to the right hip. A review of Patient 3's “Home Health Certification and Plan of Care” for the certification period of 7/18/2023 to 9/15/2023, indicated the physician ordered the skilled nurse (SN) to visit twice a week for one week, then once a week for eight weeks. The SN’s responsibilities included assessing each body system (musculoskeletal, endocrine, neurological, and digestive), vital signs, pain level, assessing/monitoring for medication compliance, knowledge, medication effectiveness, usage, route, dosage, side effects, interactions, and administration. During a joint home visit with Registered Nurse 1 (RN 1) on 8/17/2023, at 10:30 a.m., Patient 3 was sitting on the couch, awake, alert, and oriented. Patient 3 had a copy of the "Patient Handbook" at her residence, which was provided by the HHA. However, there was no copy of the plan of care provided to Patient 3. During interview with Patient 3 on 8/17/2023 at 11:25 a.m., Patient 3 said she was never given a copy of her plan of care by the HHA. During an interview with RN 1 on 8/17/2023 at 11:30 a.m., RN 1 stated the patient needed to be provided with a copy of the plan of care, so that she would know what the plan was for her and the goals. RN 1 also stated, “Patient and family can also give their input to the plan of care. They’re allowed to participate in their care.” During an interview with the Director of Patient Care Services Designee (DPCSD) on 8/18/2023 at 12:30 p.m., the DPCSD stated, “Per our policy, we are required to provide a copy of the plan of care to our patients. The Plan of care has the information about the frequency of visits, services provided for the patient, interventions, and goals. It allows the patient and the family to be actively involved in their care.” A review of the HHA’s policy, titled “Care Planning Process,” revised January 2018, indicated the organization shall provide the patient and caregiver with a copy of written instructions outlining: - Visit schedule. - Patient medication schedule/instructions. - Any treatments to be administered by the organization’s personnel and personnel acting on behalf of the organization. - Any other pertinent instruction related to the patient’s care and treatments that the organization will provide, specific to the patient’s care needs. - Name and contact information of the organization’s clinical manager.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation and interview, the home health agency (HHA) staff failed to observe infection control precautions for one of eighteen sampled patients (Patient 2). This deficient practice had the potential to expose patient and/or caregiver to infection caused by bloodborne pathogens. A review of Patient 2’s clinical record indicated a start of care date (SOC) of 8/5/2023 with a primary diagnosis of type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar or glucose; with type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin) and diabetic neuropathy is a type of nerve damage that can occur when a person has diabetes. High blood sugar (glucose) can injure nerves throughout the body. Diabetic neuropathy most often damages nerves in the legs and feet). A review of Patient 2’s “Home Health Certification and Plan of Care,” for the certification period of 8/5/2023 to 10/3/2023, indicated the Skilled Nurse (SN) was to perform the following on every visit: blood pressure, temperature, heart rate, respiration, pulse oximetry, blood sugar, and weekly weight monitoring. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/16/2023 at 2:30 p.m., Patient 2 was observed ambulating, alert and oriented. At 3:10 p.m., LVN 1 sanitized her hands with alcohol based hand rub prior to taking Patient 2’s vital signs. LVN 1 then informed Patient 2 she was going to check her blood sugar. LVN 1 did not put on disposable gloves. Patient 2 placed a new lancet on the lancing device. and then rubbed her left ring finger with an alcohol wipe for 15 seconds. LVN 1 proceeded to do the finger stick on Patient 2, without donning gloves. There was no blood coming out from Patient 2’s finger. The surveyor then observed LVN 1 pick up the lancing device, without changing the lancet, and without gloves, as she was about to reattempt a second finger stick on Patient 2. The surveyor stopped LVN 1 from proceeding with the finger stick and reminded her to change the lancet. LVN 1 then changed the lancet and proceeded to stick Patient 2’s finger without wearing gloves. After the second finger stick, the surveyor observed Patient 2 placing the used lancets on a paper towel and wrapped the used lancets with it. When asked if she had a sharps container to dispose the used lancets, Patient 2 stated she did not have one. Patient 2 stated she disposed the used lancets in a plastic bottle. The surveyor observed Patient 2 placing the used lancets inside a plastic medication container with a lid. During interview with LVN 1 on 8/16.2023 at 3:10 p.m., LVN 1 stated that she should have changed the lancet with a new one before attempting a second finger stick on Patient 2. LVN 1 stated, “Using a new lancet is important so that we know it’s sterile and doesn’t have bacteria or germs on it that can cause infection.” During the same interview, LVN 1 also stated she should have worn gloves when checking Patient 2's blood sugar. LVN 1 stated the purpose of wearing gloves was for infection control. LVN 1 stated, “Blood can carry pathogens. If I had a scrape or cut on my skin, I could get infected.” LVN 1 also stated that used lancets needed to be disposed in a sharps container to prevent the risk of injury and to prevent infection caused by blood-borne pathogens. During an interview with the Director of Patient Care Services (DPCSD) on 8/18/2023 at 12 p.m., the DPCSD stated staff needed to wear gloves when they suspected they would come into contact with bodily fluids, such as urine, blood, and bodily discharges. The DPCSD stated staff needed to use a new lancet with every finger stick to prevent cross contamination, even if it was the same patient. The DPCSD also stated that used lancets needed to be disposed in a sharps container. The DPCSD stated, “We provide our nurses with a sharps container, and if patient doesn’t have one, the nurse can dispose the lancet in the sharps container that they have. Disposing the lancets in a plastic bottle presents a risk for injury and a risk for infection. It should not have been done.” A review of the HHA’s policy, titled “Standard Precautions,” revised April 2018, indicated: · Gloves were to be worn when: - There is actual or potential contact with blood or other potentially infectious material. - Performing invasive procedure. · Syringe/sharps disposal: - In the home setting, a sharps disposal container will be available for use by the clinician or patient and family/caregiver. The uncapped needle will be placed directly into the disposal container. When ¾ full, the disposal container will be sealed and transported to the dirty supply area located in the office. A new container should be provided to the patient for any future use.

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) nursing staff failed to assess the pain level (intensity) as indicated in the plan of care, for two of 18 sampled patients (Patient 9 and Patient 11). This deficient practice had the potential to result in lack of detection of unrelieved pain and can affect the patient’s physical well-being. Findings: a. A review of Patient 9's clinical record indicated a start of care date of 7/12/2023, with diagnoses that included hypertensive heart disease (a long-term condition that develops over many years in people who have high blood pressure), type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]), and lymphedema (swelling in an arm or leg caused by a lymphatic system blockage). A review of Patient 9’s Home Health Certification and Plan of Care (POC) for the certification period from 7/12/2023 to 9/09/2023, included an order for the skilled nurse to visit the patient two times a week for one week, then three times a week for seven weeks, and then four times a week for one week, to perform assessment and observation of each body system, assess for medication compliance, knowledge, and medication effectiveness, perform vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), and perform on every visit blood sugar monitoring and pain level using pain scale, implement pain relief measures and evaluate its effectiveness. On 8/17/2023, at 11:00 a.m., a joint home visit with Licensed Vocational Nurse (LVN 2) was conducted at Patient 9’s residence. Patient 9 was observed sitting in a rollator (wheeled walker) alert and oriented (to person, place, and time) but forgetful. During an interview, Patient 9 stated he has on and off pain on both of his legs and takes pain medication as needed. A review of Patient 9's Skilled Nursing Visit Notes dated 7/20/2023, 7/26/2023 and 8/01/2023, indicated under the section “Pain”, Pain Intensity” was left blank. There was no documented evidence Patient 9's pain level was assessed and documented using the pain rating scale (a scale from 0 to 10, a score of 0 means no pain, and 10 means the worst pain you have ever felt). b. A review of Patient 11's clinical record indicated a start of care date of 7/28/2023, with diagnoses that included type 2 diabetes mellitus, epilepsy (a disorder of the brain characterized by repeated seizures), and hypertensive heart disease. A review of Patient 11’s Home Health Certification and POC for the certification period from 7/28/2023 to 9/25/2023, included an order for the skilled nurse to visit the patient once a week for one week, then twice a week for one week, and then once a week for seven weeks to perform assessment and observation of each body system, perform vital signs, assess for medication compliance, knowledge, and medication effectiveness, and to perform assessment on every visit for pain level using the pain scale, implement pain relief measures and evaluate its effectiveness. On 8/18/2023, at 10:50 a.m., a joint home visit with Licensed Vocational Nurse (LVN 4) was conducted at Patient 11’s residence. Patient 11 was observed awake, alert and oriented x 3 (to person, place, and time), and was ambulatory. During an interview, Patient 11 stated, “I have pain on both of my ankles, it comes and goes, and I take pain medicine for it.” A review of Patient 11's Skilled Nursing Visit Notes dated 8/04/2023, 8/09/2023 and 8/10/2023, indicated under the section “Pain” “Pain Intensity” was left blank. There was no documented evidence Patient 11's pain level was assessed and documented using the pain rating scale. On 8/18/2023 at 4:45 p.m., during a concurrent interview and record review with the Director of Patient Care Services Designee (DPCSD), the DPCSD acknowledged the findings for Patient 9 and Patient 11 and stated the visiting nurse should assess patient’s pain level using the pain scale 0 to 10 on every SN visit in accordance with the plan of care and the agency’s policy. A review of the agency’s policy and procedure titled “Pain Assessment,” revised January 2018, indicated pain assessments will be documented to facilitate regular reassessment and follow-up by clinicians. When the patient or the clinician identifies pain, pain assessment information will be obtained whenever possible including pain intensity using the rating scale (on a scale of 0-10: 0=no pain, 10=unbearable pain), pain location, pain quality, patterns of radiation and character, pain onset, and effects of pain. A review of the agency’s policy and procedure titled, “Care Planning Process”, revised January 2018, indicated a written plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. Based on the assessment and conclusions, the plan of care will include, but not be limited to patient specific interventions and education, and all patient care orders from all physicians involved in the plan of care, including verbal orders.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency staff failed to follow the plan of care (POC) for two of 18 sampled patients (Patient 8 and Patient 11). The visiting nurse failed to provide patient teaching regarding insulin management. This failure had the potential to affect the patient's progress in reaching their goals. Findings: a. A review of Patient 8's clinical record indicated a start of care date of 8/08/2023, with diagnoses that included hypertensive heart disease (a long-term condition that develops over many years in people who have high blood pressure), type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]) with hypoglycemia (low blood sugar), and malignant neoplasm of the prostate (prostate cancer). A review of Patient 8’s Home Health Certification and Plan of Care (POC) for the certification period from 8/08/2023 to 10/06/2023, included an order for the skilled nurse to visit the patient two times a week for six weeks, then once a week for three weeks, to perform assessment and observation of each body system, to instruct patient/caregiver on disease process of diabetes mellitus, prevention of disease exacerbation and potential complications and importance of prompt reporting to the physician (MD). SN was also to assess for medication compliance, knowledge, and medication effectiveness, and to educate patient on medication usage, route, dosage, side effects, interactions, and administration. A review of Patient 8’s current Medication Record, indicated the patient was on Novolin 70/30 (a combination insulin made with 70% of an intermediate-acting insulin [insulin NPH] and 30% of a short-acting insulin [insulin regular] for diabetes) subcutaneous injection 20 units once a day. On 8/17/2023, at 10:15 a.m., a joint home visit with Licensed Vocational Nurse (LVN 2) was conducted at Patient 8’s residence. Patient 8 was observed sitting on a wheelchair alert, oriented but forgetful, accompanied by a family member (FM 2). During a review of Patient 8's medications with FM 2, an open Novolin 70/30 Flexpen insulin was not labeled and dated when it was first used. On 8/17/2023, at 10:35 a.m., during an interview with FM 2, she stated her daughter helped her administer the insulin to Patient 8 once daily as ordered by the physician. FM 2 stated the visiting nurse did not give instructions to place the date on the insulin pen when it was first opened and/or used. FM 2 further stated she was not aware Novolin 70/30 insulin pen will expire in 28 days from the day it was first used. A further review of Patient 8's Skilled Nursing Visit notes and assessment, indicated no documented evidence the visiting nurse instructed the patient/caregiver regarding insulin management. b. A review of Patient 11's clinical record indicated a start of care date of 7/28/2023, with diagnoses that included type 2 diabetes mellitus, epilepsy (a disorder of the brain characterized by repeated seizures), and hypertensive heart disease. A review of Patient 11’s Home Health Certification and POC for the certification period from 7/28/2023 to 9/25/2023, included an order for the skilled nurse to visit the patient once a week for one week, then twice a week for one week, and then once a week for seven weeks to perform assessment and observation of each body system, perform vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), and to assess for medication compliance, knowledge, and medication effectiveness, and to educate patient on medication usage, route, dosage, side effects, interactions and administration. A review of Patient 11’s current Medication Record, indicated the patient was on Levemir insulin (long-acting insulin) subcutaneous injection 26 units once daily, and Novolog flexpen insulin (rapid-acting insulin) syringe 2 units subcutaneously before breakfast, lunch, and dinner. On 8/18/2023, at 10:50 a.m., a joint home visit with Licensed Vocational Nurse (LVN 4) was conducted at Patient 11’s residence. Patient 11 was observed awake, alert and oriented x 3 (person, place, and time), and ambulatory. During a review of Patient 11's medications with LVN 4, a used Levemir flexpen syringe and a Novolog flexpen syringe was not labeled and dated when it was first used. On 8/18/2023, at 11:10 a.m., during an interview with Patient 11, she stated she administered the insulin to herself as ordered by the physician. Patient 11 stated the visiting nurse did not give instructions to place the date on the insulin pens when it was first opened and/or used. Patient 11 further stated she was not aware Levemir flexpen syringe will expire in 42 days and the Novolog flexpen syringe will expire in 28 days from the day it was first used. On 8/18/2023 at 4:45 p.m., during a concurrent interview and record review with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated the insulin medications should be dated once it was opened or first used. She also stated that the patient should have been provided teaching on insulin management in accordance with the plan of care. A review of the agency’s policy and procedure titled, “Patient Education Process”, revised November 2018, indicated education will be the responsibility of each clinician. The patient and family/caregiver will receive verbal and as appropriate, written instructions that are in plain language that does not use medical abbreviations on the patient’s disease process and prognosis, the medical regimen, and medication management and administration.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current 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 the designated attending physician was notified and notification was documented when an ordered home visit service was missed for one of 18 sampled patients (Patient 10). This failure had the potential for the patient’s condition to deteriorate with no immediate interventions due to the lack of physician notification by the HHA. Findings: A review of Patient 10's clinical record indicated a start of care date (SOC) of 8/02/2023, with diagnoses that included cellulitis (a common skin infection caused by bacteria) of left lower limb, blister (an area of skin covered by a raised, fluid-filled bubble) left foot, and chronic kidney disease (means your kidneys are damaged and can't filter blood the way they should). A review of Patient 10’s Home Health Certification and Plan of Care (POC) for the certification period from 8/02/2023 to 9/30/2023, included an order for the Skilled nurse (SN) to visit the patient two times a week for nine weeks to perform assessment and observation of each body system, pain monitoring, perform vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), and to reconcile medications with the physician via medication reconciliation A review of Patient 10’s clinical records indicated there was a SN missed visit note dated 8/10/2023. The reason for the missed visit was indicated “No answer to phone call." The note further indicated the physician was not notified. On 8/18/2023 at 4:45 p.m., during a concurrent interview and record review with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated for any missed visit, the patient’s attending physician should be notified promptly per the agency’s policies and procedures. A review of the agency’s policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician”, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician will be contacted on the same day when any of the following occur: when a visit is missed for any reason.