Every finding on record at Happy HHA, Inc.

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey, from 10/12/2022 to 10/18/2022 at 650 W. Duarte Road, Suite 402, Arcadia, CA. 91007 Complaint Intake Number: 93799 Representing the California Department of Public Health: Surveyor ID #19096, Health Facilities Evaluator Nurse Surveyor ID #44290, Health Facilities Evaluator Nurse Census: Sample Size: 17 Home Visits: 7 Closed Records: 5 The following Condition of Participations (COP) were not met: 484.60 Care planning, Coordination, and Quality of Care 484.75 Skilled Professional Services

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 two of 17 sampled patients, (Patient 1 and 2) received their Patient Rights and Responsibilities forms written in a language that the patient understands. This deficient practice had the potential to cause Patient 1 and 2 not to have a full understanding of what their rights and responsibilities were with the HHA. a. A review of Patient 1’s Patient Information (Face Sheet) indicated the start of care (SOC) was on 9/26/22 with diagnosis that included left hemiplegia (left side body weakness) caused by cerebral infarction (stroke). Patient’s stated language was English. A review of Patient 1’s rights and responsibilities (Patient Consent) form dated 9/26/22, was written in English. During an interview conducted on 10/14/22, at 10:48am, Patient 1 stated that his primary language was Cantonese. Patient 1 stated that he could not read the patient consent form well and does not understand the whole document. b. A review of Patient 2’s Patient Information indicated the SOC was on 10/7/22, with diagnosis of non-pressure chronic ulcer (open sore or wound on the skin) of buttocks and right lower leg. Patient’s stated language was English. A review of Patient 2’s rights and responsibilities (Patient Consent) form dated 10/7/22, was written in English. During an interview conducted on 10/14/22, at 11:32 a.m,, Patient 2 stated that his primary language was Mandarin. Patient 2 stated he did not know what the Consent Form said, but his nurse explained to him that it was in Mandarin and told him to sign. During an interview on 10/18/22, at11:30 a.m., the Director of Patient Care Services (DPCS) stated that the Intake Coordinator puts patient language on face sheet. The Nurse goes over the resident’s rights with the patient during the initial assessment. DPCS stated that the HHA does have resident rights form in Chinese language and that the consent form should have been given in Chinese, so the patient understands what they are signing. A review of the HHAs policy titled “Communication With Non-English or Communication-Impaired Patient”, dated 5/7/21, indicated that staff shall ensure that patients and/or their caregivers receive information and instructions in a language they can reasonably be expected to understand. The policy also addresses the Patient’s Rights and Responsibilities form and the Patient’s Consent, although it only mentions that the forms shall be available in Spanish translation in all offices. It does not address any other languages.

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 updated medication profile for four of 17 sampled patients, (Patients 1, 2, 8 and 14). This failure had the potential to cause adverse side effects to the medications. a. A review of Patient 1’s Patient Information (Face Sheet) indicated that their start of care (SOC) was on 9/26/22 with a diagnosis of left Hemiplegia (left side body weakness) caused by cerebral infarction (stroke: brain bleed). During a home visit conducted on 10/14/22, at 10am with Physical Therapist 1 (PT1) Patient 1’s medications were reviewed, and a discrepancy showed that a medication dosage that the patient was taken was different from the dosage listed on the medication profile. A review of Patient 1’s medication profile for 9/26/22-11/24/22 indicated an order for Timoptic-XE Ophthalmic (eye drop medication used to treat high blood pressure inside the eye caused by glaucoma: eye condition that can cause blindness) 0.25% 10 milliliter (ml: unit of measurement) 1 drop instill to both eyes every morning. Patient 1’s home medication bottle which was filled on 3/22/22, indicated Timoptic-XE 0.5%. During an interview on 10/18/22 at 11:15am, Registered Nurse 1 (RN1) stated that she did not check the percentage on the medicine bottle and compare it to the med profile. A review of Patient 1’s plan of care (POC) for certification period 9/26/22-11/24/22, indicated that he was to have skilled nursing (SN) visits twice a week for one week, then once a week for eight weeks. SN is to provide assistance with patient’s medication regimen. SN is to instruct patient/caregiver on correct medication dose, frequency, route, indication, and important potential side effects and interactions. b. A review of Patient 2’s Patient Information indicated SOC was on 10/7/22, with diagnosis of non-pressure chronic ulcer (open sore or wound on the skin) of buttocks and right lower leg. During a home visit conducted on 10/14/22, at 11:32am, Patient 2’s medications were reviewed with Licensed Vocational Nurse 1 (LVN1). Two bottles of Fluocinonide solution (Lidex: corticosteroid used on skin to treat itching and redness) 0.05%-topical, apply to affected area daily. One bottle had fill date of 8/4/22 and second bottle had fill date of 10/3/22. Patient 2 stated that he only uses the medication sometimes. During a concurrent interview and record review on 10/14/22 at 11:52am, Patient 2’s Medication Profile dated 10/7/22-12/5/22 did not have Lidex listed. LVN1 stated that the medication should have been added to the medication profile, and she would update list. A review of Patient 2’s plan of care (POC) for certification period 10/7/22-12/5/22, indicated that he was to have skilled nursing (SN) visits twice a week for one week, then once a week for eight weeks. SN is to provide assistance with patient’s medication regimen. SN is to instruct patient/caregiver on correct medication dose, frequency, route, indication, and important potential side effects and interactions. During an interview on 10/18/22 at 11/48am, the Director of Patient Care Services (DPCS) stated that during each home visit the nurses are to check the patient’s medication bottle and compare it to what is listed on the medication profile. A review of the HHAs policy titled “Medication Profile”, dated 5/3/09, indicated that SN or therapist needs to assess all the medications that a patient has been taking at home when doing the initial evaluation and thereafter when a patient has new medication changes. SN or therapist needs to record the medications into the medication profile which include name, dosage, route, frequency, new or change of medication, allergy history and the start of medication date. This is to ensure patients are taking their medications safely. c. A review of Patient 8’s record titled, “ Home Health Certification and Plan of care (POC) with the certification period of 10/5/22 to 12/3/22, indicated the start of care (SOC) date for Patient 8 was 10/5/22, with diagnosis of hypertensive chronic kidney disease (renal hypertension, high blood pressure caused by the narrowing of your arteries that carry the blood to your kidneys), chronic kidney disease, stage 3 ( mild to moderate damage which makes the kidneys less able to filter waste and fluid out of your blood) and muscle weakness. A review of Patient 8’s medical record titled, “Home Health Certification period of 10/5/22 to 12/3/22, indicated RN 2 to visit two times a week for one week and one time a week for eight weeks to assess patients vital signs and determine caregivers’ ability to provide assistance with patient’s medication regiment management, instruct patient/caregiver on safety with medication management and to instruct correct medication dose, frequency, route, indications. and on the important potential side effects and interactions. A home visit was conducted on 10/14/22, at 10 a.m., with the LVN at the Assisted Living Facility (ALF) where Patient 8 resides. Review of Patient 8’s medication in the ALF medication room and the medication profile from the HHA indicated the following medications were not listed on the HHA’s medication profile: 1. Allopurinol 100 mg, 1 tablet by mouth daily for gout Patient 8’s Medication in the ALF Medication Administration record did not list the following medications: 1. Vitamin D3 25 MCG ( 1000 IU) 1 tablet daily. 2. Multivitamin-minerals 1 tablet by mouth daily 3. Milk of magnesia oral 1200 MG/15 ML 30 ml by nouth every 24 hrs as needed for constipation, And 4. Fleet Enema Rectal 7=-19 GM/ 118 ML insert 1 dose rectally every 48 hours as needed for constipation if Milk of Magnesia is ineffective d. A review of Patient 14’s clinical record titled, “Home Health Certification and Plan of care (POC) with the certification period of 9/12/22 to 11/10/22, indicated the start of care(SOC) date for Patient 8 was 9/12/22, with diagnosis of hypertensive chronic kidney disease, chronic kidney disease, stage and muscle weakness. A review of Patient 14’s medical record titled, “Home Health Certification period of 9/12/22 to 11/10/22, indicated SN to visit one week and one time a week for nine weeks to assess patients vital signs and determine caregivers’ ability to provide assistance with patient’s medication regiment management, instruct patient/caregiver on safety with medication management and to instruct correct medication dose, frequency, route, indications. and on the important potential side effects and interactions. A home visit was conducted on 10/17/22, at 11 a.m., with the LVN at the ALF where Patient 14 resides. During a concurrent review of Patient 14’s medication with the LVN and Patient 14 in his room, indicated Gabapentin 100mg 1 capsule twice a day with the prescription fill date of 8/25/22. Patient 14 stated he has not been taking this medication for over 2 weeks now because it caused him to hallucinate. During an interview with LVN1, after the home visits, she stated she was not aware Patient 14 was no longer taking the medication and she will update the medication profile. During an interview with the Director of Patient Care Services and the Administrator Designee on 10/18/22, at 1 p.m., they stated that nursing should be doing medication reconciliation every home visit and double check with what the patient has in the house. A review of the HHAs policy titled “Medication Profile”, dated 5/3/09, indicated that SN or therapist needs to assess all the medications that a patient has been taking at home when doing the initial evaluation and thereafter when a patient has new medication changes. SN or therapist needs to record the medications into the medication profile which include name, dosage, route, frequency, new or change of medication, allergy history and the start of medication date. This is to ensure patients are taking their medications safely.

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 meet the Condition of Participation for Care planning, Coordination and Quality of care as follows: 1. The HHA failed to ensure each patient received services in accordance with the patient's plan of care for one of 17 sampled patients (Patient 11) when Registered Nurse 2 (RN 2) administered the wrong medication (Ceftriaxone antibiotic medication that is used to treat or prevent certain infections caused by bacteria) to Patient 11 and that was not ordered by the physician. (Refer to G 572) 2. The HHA failed to ensure the drug that was ordered by the physician was administered to one of 17 sampled patients (Patient 11). For Patient 11, the physician had ordered to administer Cefepime (used to treat bacterial infections in many different parts of the body) antibiotic medication to Patient 11, and Registered Nurse 2 (RN 2) administered Ceftriaxone, (used to treat or prevent certain infections caused by bacteria), a wrong antibiotic medication for Patient 11. This deficient practice resulted in Patient 11 received Ceftriaxone, a wrong antibiotic medication, was expired and which had the potential for the patient to experience side effects (unwanted response to a medication) of medication including allergic reaction (rash, swelling/itching, trouble breathing), bleeding/easy bruising, unusual tiredness, abdominal pain, diarrhea that does not stop, nausea, vomiting, and pink/bloody dark urine. (Refer to G 580) 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 Carew to ensure the highest quality of health care is 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 each patient received services in accordance with the patient's plan of care for one of 17 sampled patients (Patient 11) when Registered Nurse 2 (RN 2) administered the wrong and expired medication (Ceftriaxone antibiotic medication that is used to treat many kinds of bacterial infections) to Patient 11 and that was not ordered by the physician. This deficient practice resulted in Patient 11 received Ceftriaxone, a wrong antibiotic medication which had the potential for the patient to experience side effects (unwanted response to a medication) of medication including allergic reaction (rash, swelling/itching, trouble breathing), bleeding/easy bruising, unusual tiredness, abdominal pain, diarrhea that does not stop, nausea, vomiting, and pink/bloody dark urine. A review of Patient 11’s record titled, “ Home Health Certification and Plan of care (POC) with the certification period of 2/23/22 to 4/23/22, indicated the start of care (SOC) date for Patient 11 was 2/23/22,with diagnoses including cellulitis of right lower limb ( a common, potential serious bacterial skin infection that causes swelling and inflammation of the skin, typically painful and warm to touch ) and encounter of adjustment and management of VAD by administration of IV antibiotics by a PICC line. A review of Patient 11’s record titled, “Home Health Certification period of 2/23/22 – 4/23/22, indicated RN 2 was to visit daily to administer Cefepime (an antibiotic medication used to treat bacterial infection) intravenously (IV), one gram (gm) daily for 12 hours for five (5) weeks, and to administer Micafungin( an antifungal medication) 100 milligrams (mg) daily for five (5) weeks via peripherally inserted central catheter (PICC, peripherally inserted central catheter, which allows repeated and long-term access to the bloodstream for frequent or regular administration of intravenous drugs) line using the Curlin Pump ( a portable infusion pump used for continuous, intermittent and variable infusions in home care setting. During a interview with RN 2 on 10/18/22, at 10 a.m. in the HHA office, RN 2 stated that he called Patient 11 on the day of the home visit to check if the medication had arrived and Family Member 1 informed him the medication was in the house. RN 2 stated he was informed that the patient was a registered nurse and did not need assistance with the antibiotic administration intravenously. RN 2 stated he did not check the pharmacy regarding medication order prior to his visit. RN 2 stated when he arrived to Patient 11’s house and asked for the medication, Family Member 1 gave him the medication (Ceftriaxone) that came from the refrigerator and he administered Ceftriaxone (antibiotic that is used to treat many kinds of bacterial infections) 2 gm by IV push (medication is given rapidly and pushed into the bloodstream with a syringe). RN 2 stated he made an arrangement to visit Patient 11 two days later and he was never informed by Patient 11 or her family that he had given the wrong medication. RN 2 stated he called Patient 11 few days later to schedule another home visit and was informed by Family Member 1 that they had another licensed nurse to do the home visit. RN 2 stated he should have checked the physician's order and generated a pharmacy order before giving the medication to Patient 11. RN 2 stated that he did not find out he gave the wrong medication until few months later when the surveyor from the Department of Public Health came to the agency to investigate. During an interview with the Director of Patient Care Services (DPCS) and the Administrator Designee, in the HHA office on 10/18/22 at 10:30 a.m., they both stated they were not informed of the medication error or complaint until the surveyor came to the agency for complaint investigation (under State process) in April 2022. They both stated the process is to receive the order via email, print the medication order out, call the patient to schedule a home visit, check the physician's order and generated a medication order from the pharmacist and when in doubt, clarify the order with the physician/pharmacist and re-check the order at the patients home during the home visit. During an interview with the Administrator on 10/18/22, she stated she was out on medical leave and found out when the surveyor came to the agency. The DPCS and Administrator Designee stated they had counseled RN 2 and RN 2 received an serviced on medication administration. A review of the Employee Counseling & Disciplinary Action Report dated 5/10/22 at 5:00 p.m. completed by the agency's DPCS indicated a complaint regarding RN 2's home visit at Patient 11's house on 2/23/22. RN 2 conducted a home visit at Patient 11's home to administer antibiotic medication intravenously to Patient 11. RN 2 administered Ceftriaxone 2 gm intravenously to Patient 11. There was no physician order to administer Ceftriaxone which was expired medication. RN 2 indicated he administered Ceftriaxone without checking the physician order and expiration date of the medication. A written counseling was given, letter of suspension was given until the investigation was completed, and RN 2 reviewed the agency's policies on medication administration, physician order for medication and post test for medication management/administration. A review of the agency's report dated 5/10/22 indicated the DPCS sent a letter to RN 2 that indicated RN 2 was informed a complaint regarding her home visit on 2/23/22, and RN 2 had given a wrong and expired medication (Ceftriaxone) intravenously to Patient 11. RN 2 did not check the physician order before administering the medication intravenously and did not contact the agency to verify the physician order to administer Ceftriaxone to Patient 11. The agency's action plan included inservice on medication management and medication error and written counseling for RN 2. A review of the HHA policy titled, “Patient Care” dated 7/31/2001, indicated the agency staff would "verify with the physician any incomplete, illegible or unclear medication is ordered prior to administering the medication and/or providing patient education about the medication.” A review of the WebMD online retrieved on 10/31/22 indicated the side effects of Ceftriaxone included allergic reaction (rash, swelling/itching, trouble breathing), bleeding/easy bruising, unusual tiredness, abdominal pain, diarrhea that does not stop, nausea, vomiting, and pink/bloody dark urine.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure the drug was administered only as ordered by the physician for one of 17 sampled patients (Patient 11). For Patient 11, Registered Nurse 2 (RN 2) administered Ceftriaxone (used to treat or prevent certain infections caused by bacteria) intravenously to Patient 11, without checking the physician's order to ensure the correct medication was given to Patient 11. This deficient practice resulted in Patient 11 received Ceftriaxone, a wrong antibiotic medication which had the potential for the patient to experience side effects (unwanted response to a medication) of medication including allergic reaction (rash, swelling/itching, trouble breathing), bleeding/easy bruising, unusual tiredness, abdominal pain, diarrhea that does not stop, nausea, vomiting, and pink/bloody dark urine. During a complaint validation survey on 10/18/22, an investigation was conducted regarding an allegation that on 2/23/22, RN 2 went to Patient 11's residence to administer an antibiotic medication, and he administered the wrong medication [Ceftriaxone 20 milligrams, (mg)] in a 20 milliliters (ml) syringe. The allegation indicated Ceftriaxone antibiotic was from the previous HHA and the antibiotic had expired on 1/26/22. A review of Patient 11’s record titled, “Home Health Certification and Plan of Care (POC) with the certification period of 2/23/22 to 4/23/22, indicated the start of care(SOC) date for Patient 11 was 2/23/22,with diagnoses including cellulitis of right lower limb ( a common potential serious bacterial skin infection that causes swelling and inflammation of the skin, typically painful and warm to touch ) and encounter of adjustment and management of VAD. A review of Patient 11’s record titled, “Home Health Certification period of 2/23/22 – 4/23/22, indicated RN 2 was to visit daily to administer Cefepime antibiotic, one gram daily, for 12 hours, for 5 weeks, and Micafungin (an antifungal medication) 100 mg via peripherally inserted central catheter (PICC, allows repeated and long-term access to the bloodstream for frequent or regular administration of drugs) line using the Curlin Pump ( a potable infusion pump used for continuous, intermittent and variable infusions in home care setting. During an interview with RN 2 on 10/18/22, at 10 a.m. in the office of the HHA, RN 2 stated that he called Patient 11 on the day of the home visit to check if the medication had arrived. RN 2 stated Family Member 1 informed him that the medication was in the house. RN 2 stated he was informed that the patient was a registered nurse and did not need assistance with the administration of the medication intravenously. RN 2 stated he did not check the pharmacy order for the medication prior to his visit and when he arrived to Patient 11’s house and asked for the medication, Family Member 1 gave him the medication that came from the refrigerator and he administered Ceftrioxone 2 gm IV push. RN 2 stated he made arrangement to conduct home visit again two days later and was never informed by Patient 11's or her family that he had given the wrong medication. RN 2 stated he called the patient a few days later to schedule another appointment and was informed by Family Member 1 that they had another licensed nurse. RN 2 stated he should have checked the physician's order and the generated pharmacist order before giving the medication to Patient 11. RN 2 stated that he did not find out he gave the wrong medication until a few months later when the surveyor (a public employee who inspects health facilities) from the California Department of Public Health (the state department responsible for public health in California) came to the agency. During an interview with the Director of Patient Care Services (DPCS) and the Administrator Designee, in the HHA office on 10/18/22 at 10:30 a.m., they both stated they were not informed of the medication error or complaint until the surveyor had investigated the complaint (under the State process) at the agency in April 2022. They both stated the process is to receive the medication order via email, print the medication order out, call the patient to schedule a visit, check the physician's order and generated an order from pharmacist and when in doubt, clarify the order with the physician/pharmacist and re-check order when conducting the visit at the patient's home. The DPCS and Administrator Designee stated they had counseled RN 2 and RN 2 received in-serviced on medication administration. During an interview with the Administrator on 10/18/22, she stated she was out on medical leave and found out when the surveyor had came to the office to investigate the complaint. A review of the Employee Counseling & Disciplinary Action Report dated 5/10/22 at 5:00 p.m. completed by the agency's DPCS indicated a complaint regarding RN 2's home visit at Patient 11's house on 2/23/22. RN 2 conducted a home visit at Patient 11's home to administer antibiotic medication intravenously to Patient 11. RN 2 administered Ceftriaxone 2 gm and Cefepime 1 gm intravenously to Patient 11. There was no physician order to administer Ceftriaxone which was expired medication. RN 2 indicated he administered Ceftriaxone without checking the physician order and expiration date of the medication. A written counseling was given, letter of suspension was given until the investigation was completed, and RN 2 reviewed the agency's policies on medication administration, physician order for medication and post test for medication management/administration. A review of the agency's report dated 5/10/22 indicated the DPCS sent a letter to RN 2 that indicated RN 2 was informed a complaint regarding her home visit on 2/23/22, and RN 2 had given a wrong and expired medication (Ceftriaxone) intravenously to Patient 11. RN 2 did not check the physician order before administering the medication intravenously and did not contact the agency to verify the physician order to administer Ceftriaxone to Patient 11. The agency's action plan included inservice on medication management and medication error and written counseling for RN 2. A review of the HHA policy titled, “Patient Care” dated 7/31/201, indicated the agency staff would "verify with the physician any incomplete, illegible or unclear medication that is ordered prior to administering the medication and/or providing patient education about the medication.” A review of the WebMD online retrieved on 10/31/22 indicated the side effects of Ceftriaxone included allergic reaction (rash, swelling/itching, trouble breathing), bleeding/easy bruising, unusual tiredness, abdominal pain, diarrhea that does not stop, nausea, vomiting, and pink/bloody dark urine.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure that one of 17 sampled patients, (Patient 2), was educated on the proper use of its medication. This failure had the potential to cause Patient 2 use the medication incorrectly and could result to an adverse reaction. A review of Patient 2’s Patient Information indicated SOC was on 10/7/22, with diagnosis of non-pressure chronic ulcer (open sore or wound on the skin) of buttocks and right lower leg. During a home visit conducted on 10/14/22, at 11:32 a.m., Patient 2’s medications were reviewed with Licensed Vocational Nurse 1 (LVN). Two bottles of Fluocinonide solution (Lidex, a corticosteroid used on skin to treat itching and redness) 0.05% topical, apply to affected area daily. One bottle had a fill date of 8/4/22 and second bottle had a fill date of 10/3/22. Patient 2 stated that he only uses the medication sometimes. During a concurrent interview and record review on 10/14/22, at 11:52 a.m., Patient 2’s Medication Profile dated 10/7/22 to 12/5/22 did not have Lidex listed. LVN1 stated that the medication should have been added to the medication profile, and she would update the list. Patient 2 was asked what the medication was used for, and he pointed up his nose. LVN1 corrected him and stated it was to be used on his skin. Patient 2 then remembered it was for itching. A review of Patient 2’s plan of care (POC) for certification period 10/7/22 to 12/5/22, indicated that Patient 2 was to have skilled nursing (SN) visits twice a week for one week, then once a week for eight weeks. SN is to provide assistance with patient’s medication regimen. SN is to instruct patient/caregiver on correct medication dose, frequency, route, indication, and important potential side effects and interactions. During an interview on 10/18/22 at 11/48 a.m., the Director of Patient Care Services (DPCS) stated that it is important for nurse to go over medications with the patients because they forget, and to ensure the medications are used correctly. During each home visit the nurses are to check the patient’s medication bottle and compare it to what is listed on the medication profile. A review of the HHAs policy titled “Medication Profile”, dated 5/3/09, indicated that SN or therapist needs to assess all the medications that a patient has been taking at home when doing the initial evaluation and thereafter when a patient has new medication changes. SN or therapist needs to record the medications into the medication profile which include name, dosage, route, frequency, new or change of medication, allergy history and the start of medication date. This is to ensure patients are taking their medications safely.

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 interview and record, the Home Health Agency (HHA) failed to meet the Condition of Participation for Skilled Professional Services as follows: (Refer to G710) The home health agency (HHA) failed to verify the physician's order for an antibiotic medication before it was administered intravenously (IV, medication administration within a vein) by the Registered Nurse to one of 17 sampled patients, Patient 11. Patient 11 was administered the wrong medication (Ceftriaxone antibiotic medication that is used to treat or prevent certain infections caused by bacteria) intravenously, that was expired and that was not ordered by the physician. This failure of administering a wrong and expired medication placed Patient 11 at risk for a serious adverse drug reactions that could be life threatening and had the potential that Patient 11’s current infection will not get resolved that can cause more serious health complications. This cumulative effect of these systematic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal regulations for Skilled Professional Services to ensure the highest quality of health care is provided to patients who receive home health services. .

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 interview and record review, the home health agency failed to follow the plan of care for one of seventeen sampled patients, Patient 11, when the Registered Nurse (RN) administered the wrong medication (Ceftriaxone antibiotic medication that is used to treat or prevent certain infections caused by bacteria) intravenously, that was expired and that was not ordered by the physician. This failure in administering a wrong and expired medication placed Patient 11 at risk for a serious adverse drug reactions that could be life threatening and had the potential that Patient 11’s current infection will not get resolved and could cause a more serious health complication. A Complaint Validation survey was conducted on 10/18/22 due to the allegation that on 2/23/22, Registered Nurse (RN) 2 went to the residence of Patient 11 and had administered the wrong medication Ceftriaxone 20 mg in 20 milliliters (ml) syringe (antibiotic medication that is used to treat or prevent certain infections caused by bacteria) which was from an old home health agency (HHA) that had an expiration date of 1/26/22. A review of Patient 11’s record titled, “ Home Health Certification and Plan of care (POC) with the certification period of 2/23/22 to 4/23/22, indicated the start of care(SOC) date for Patient 11 was 2/23/22, with diagnoses of cellulitis of right lower limb (a serious bacterial skin infection that causes swelling and inflammation of the skin) and management of peripherally inserted central catheter [PICC, port allows repeated and long-term access to the bloodstream for frequent or regular administration of drugs, like intravenous (IV, within the vein) antibiotics). A review of Patient 11’s medical record titled, “Home Health Certification” period of 2/23/22 to 4/23/22, indicated RN 2 to visit daily to administer IV Cefepime (an antibiotic medication use to treat bacterial infections) 1 gram (gm) daily every 12 hours for 5 weeks, and Micafungin (an antifungal medication) 100 milligrams (mg) via PICC line daily times 5 weeks. During an interview on 10/18/22, at 10 a.m., RN 2 stated that he called Patient 11 that day of the visit to check if the medication had arrived. RN 2 was told by family member 1 that the medication had been delivered. RN 2 stated he was informed that Patient 11 was a Registered Nurse and did not need daily assistance with the IV administration. RN 2 also stated he did not check the pharmacy order for the medication prior to his visit and when he arrived at Patient 11’s house, he asked for the medication. Family member 1 then gave him the medication from the refrigerator that was the Rocephin 2 gm that he administered via IV push. When asked, RN 2 stated he should have checked the physician's order and the pharmacy generated order before giving the medication Rocephin to Patient 11 to ensure that the correct medication was given. RN 2 also stated that he did not find out about the wrong medication given until a few months later when the surveyor (a public employee who inspects health facilities) from the California Department of Public Health (the state department responsible for public health in California) came in. During an interview with the DPCS and the Administrator Designee, (ADM. Designee) in the HHA on 10/18/22 at 10:30, they both stated they were not informed of the medication error or complaint until the surveyor walk in the agency in April 2022. They both stated the process is to receive the order via email, print the order out, call the patient to schedule a visit, check the physician's order and generate order from pharmacy and when in doubt, clarify the order with the physician/pharmacist and re-check order when at the patient’s home. During an interview with the Administrator on 10/18/22, she stated she was out on medical leave and found out when the surveyor walked into the office. The DPCS and Adm. Designee and RN 2 stated RN 2 was counselled and in serviced on medication administration. A review of the Employee Counseling & Disciplinary Action Report dated 5/10/22 at 5:00 p.m. completed by the agency's DPCS indicated a complaint regarding RN 2's home visit at Patient 11's house on 2/23/22. RN 2 conducted a home visit at Patient 11's home to administer antibiotic medication intravenously to Patient 11. RN 2 administered Ceftriaxone 2 gm intravenously to Patient 11. There was no physician order to administer Ceftriaxone which was expired medication. RN 2 indicated he administered Ceftriaxone without checking the physician order and expiration date of the medication. A written counseling was given, letter of suspension was given until the investigation was completed, and RN 2 reviewed the agency's policies on medication administration, physician order for medication and post test for medication management/administration. A review of the agency's report dated 5/10/22 indicated the DPCS sent a letter to RN 2 that indicated RN 2 was informed a complaint regarding her home visit on 2/23/22, and RN 2 had given a wrong and expired medication (Ceftriaxone) intravenously to Patient 11. RN 2 did not check the physician order before administering the medication intravenously and did not contact the agency to verify the physician order to administer Ceftriaxone to Patient 11. The agency's action plan included in-service on medication management and medication error and written counseling for RN 2. A review of the WebMD online retrieved on 10/31/22 indicated the side effects of Ceftriaxone included allergic reaction (rash, swelling/itching, trouble breathing), bleeding/easy bruising, unusual tiredness, abdominal pain, diarrhea that does not stop, nausea, vomiting, and pink/bloody dark urine. A review of the HHA policy titled “Patient Care” dated 7/31/201, indicated, agency staff will verify with the physician any incomplete, illegible, or unclear medication ordered prior to administering the medication and/or providing patient education about the medication.”

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to provide training and education, to one of 17 sampled Patients, Patient 11, in the use of an intravenous (IV) machine pump to deliver IV medications through the PICC line. This failure had the potential for an incorrect way the medicine will be delivered and can cause delay in the administration of the medications. A review of Patient 11’s record titled, “ Home Health Certification and Plan of care (POC) with the certification period of 2/23/22 to 4/23/22, indicated the start of care(SOC) date for Patient 11 was 2/23/22,with diagnoses of cellulitis of right lower limb (a serious bacterial skin infection that causes swelling and inflammation of the skin, typically painful and warm to touch ) and management of VAD [Peripherally inserted central catheter PICC/port, allows repeated and long-term access to the bloodstream for frequent or regular administration of drugs, like intravenous (IV, administered within a vein) antibiotics] A review of Patient 11’s medical record titled, “Home Health Certification period of 2/23/22 – 4/23/22, indicated RN 2 to visit daily to administer IV Cefepime (an antibiotic medication used to treat bacterial infections) 1-gram (gm) daily every 12 hours for 5 weeks, and Micafungin (an antifungal medication) 100 mg. via PICC line (a type of long catheter that is inserted through a peripheral vein, often in the arm, into a larger vein in the body) daily times 5 weeks. During a interview with Registered Nurse (RN) 2 on 10/18/22, at 10 a.m., RN 2 stated he was informed that the Patient 11 was a Registered Nurse and did not need daily assistance with the IV administration. RN 2 stated he did not instruct Patient 11 or the family member on how to use the Curlin Pump and how to administer the medication using the Curlin pump. RN 2 stated he should have instructed Patient 11 and his family member on the IV technique of medication administration. During an interview with the Director of Patient Care Services (DPCS) and the Administrator Designee, (ADM. Designee) on 10/18/22 at 10:30 a.m., they both stated they were contacted by the family a few days later due to a clogged lumen of the PICC line. During an interview on 10/18/22 at 11:48 a.m., the DPCS stated that it is important for the nurse to go over the medications with the patient because they forget, and to ensure the medications are used correctly. A review of the HHAs policy titled “Medication Profile”, dated 5/3/09, indicated that SN or therapist needs to assess all the medications that a patient has been taking at home when doing the initial evaluation and thereafter when a patient has new medication changes. SN or therapist needs to record the medications into the medication profile which include name, dosage, route, frequency, new or change of medication, allergy history and the start of medication date. This is to ensure patients are taking their medications safely.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure that the Patient Profile (Face Sheet) for two of 17 sampled patients, (Patients 1 and 2) had documented the correct language of the patient. This deficient practice caused Patient 1 and 2 to receive their Patient Rights and Responsibilities Consent form in a language written that they did not understand. a. A review of Patient 1’s Patient Information (Face Sheet) indicated that the start of care (SOC) was on 9/26/22 with a diagnosis of left hemiplegia (left side body weakness) caused by cerebral infarction (stroke). Patient’s stated language was English. A review of Patient 1’s rights and responsibilities (Patient Consent) form dated 9/26/22, was written in English. During an interview conducted on 10/14/22, at 10:48am, Patient 1 stated that his primary language was Cantonese. Patient 1 stated that he could not read the patient consent form well and does not understand whole document. b. A review of Patient 2’s Patient Information indicated SOC was on 10/7/22, with diagnosis of non-pressure chronic ulcer (open sore or wound on the skin) of buttocks and right lower leg. Patient’s stated language was English. A review of Patient 2’s rights and responsibilities (Patient Consent) form dated 10/7/22, was written in English. During an interview conducted on 10/14/22, at 11:32am, Patient 2 stated that his primary language was Mandarin. Patient 2 stated he did not know what the Consent Form said, but his nurse explained to him what it was in Mandarin and told him to sign. During an interview on 10/18/22, at11:30am, the Director of Patient Care Services (DPCS) stated that the Intake Coordinator puts patient language on face sheet. The nurse goes over the resident’s rights with patient during the initial assessment. DPCS stated that the HHA does have resident rights form in Chinese. DPCS stated that consent form should have been given in Chinese, so the patient understands what they are signing. A review of the HHAs policy titled “Communication With Persons With Limited English Proficiency (LEP)”, dated 5/7/21, indicated that the HHA will promptly identify the language and communication needs of the LEP person, and the language used to communicate with the LEP person will be included as part of the record.