Every finding on record at Sunrise Home Care Services Inc

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the California Department of Public Health: Surveyor #, 25046, Health Facilities Evaluator Nurse Surveyor # 22303, Health Facilities Evaluator Nurse Unduplicated Admissions -48 Active Patients - 20 Sample Size - 7 Home Visits- 3 The following three Conditions of Participation were not met: 484.55 Comprehensive Assessment of Patients 484.60 Care Planning, Coordination of Services and Quality of Care 484.65 Quality Assessment Performance Improvement

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview, and record review, the home health agency (HHA) failed to ensure the emergency preparedness training for all staff was conducted at least annually. This failure had the potential to result in the HHA staff having a lack of knowledge to readily and effectively respond during an emergency crises situation. A review of the agency's Emergency Preparedness Program indicated there was no documented evidence Emergency Preparedness training was provided to all HHA staffs. On 1/13/23, at 11:30 a.m., during an interview with the Director of Patient care services (DPCS), DPCS stated she did not conduct Emergency Preparedness training for all staffs. The HHA's undated policy and procedure titled, "Emergency Preparedness Plan" indicated the plan uses the term "all hazard" to address all types of incidents. The incidents which may require action by home care and emergency service personnel to prevent or minimize loss of life or damage to property and environment.

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the California Department of Public Health: Surveyor # 25046, Health Facilities Evaluator Nurse Surveyor # 22303, Health Facilities Evaluator Nurse Unduplicated Admissions -48 Active Patients - 20 Sample Size - 7 Home Visits- 3 The following three Conditions of Participation were not met: 484.55 Comprehensive Assessment of Patients 484.60 Care Planning, Coordination of Services and Quality of Care 484.65 Quality Assessment Performance Improvement

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to review and update the "Medication Profile" (the information about the medicines a person is using and has used) for three of seven sampled patients (Patient 1, 5, 6). (Refer to G 536) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment. .

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) staff failed to review the medication regimen of three of seven sampled patients (Patients 1, 5, 6) and compare the medications with the medication profile and clarify the discrepancies with the physician, and failed to ensure a patient’s medications were not expired for three of seven sampled patients (Patients 1,5,6). This deficient practice had the potential to place the patient at risk for medication errors and allowing the patient to use expired medication. a. A review of Patient 5's plan of care (POC) for the certification period from 12/14/2022 to 2/11/2023, indicated start of care (SOC) dated 4/18/2022, with diagnoses that included type 2 Diabetes Mellitus (DM - A chronic condition that affects the way the body processes blood sugar) and type 1 DM. The skilled nurse (SN) was to visit the patient once a week for 9 weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems and compliance with dietary and medication regimen. On 1/12/2023, at 10:20 a.m., during a home visit at Patient 5’s house with the Director of Patient Care Services (DPCS), Patient 5 was observed alert and oriented, able to communicate well, and was ambulatory without using any assistive device. Family member 1 was next to the patient. At 10:40 a.m., during a review of Patient 5's current medications compared with the medication profile provided by the agency, the following was observed: 1. Patient 5 had a bottle of Metformin 1000 milligram (mg) labeled to take one tablet two times a day (dated 10/20/2022), while the medication record indicated to take one 500 mg tablet twice daily. During an interview with Patient 5, he stated Metformin 500 mg was increased to 1000 mg since 10/20/2022. 2. Patient 5 had a bottle of Meloxicam 15 mg labeled to take one tablet as needed (dated 4/29/2022), while it was not indicated in the medication record. During an interview with Patient 5, he stated he had been taking Meloxicam 15 mg once in a while. 3. Patient 5 had a bottle of Omeprazole 20 mg labeled to take one capsule daily (dated 12/15/2022), while it was not included in the medication record. During an interview with Patient 5, he stated he had been taking Omeprazole 20 mg one capsule everyday since 12/15/2022. 4. Patient 5 had a bottle of Baclofen 10 mg to take everyday (dated 4/29/2022), while it was indicated in the medication record to take twice a day. 5. The medication record included Lyrica 50 mg to take one capsule twice daily, Protonix 40 mg one tablet to take once daily, and Zoloft 25 mg to take one tablet daily. However, Patient 5 did not have those medication at home. b. A review of Patient 6's plan of care (POC) for the certification period from 11/13/2022 to 1/11/2023, indicated start of care (SOC) dated 3/18/2022, with diagnoses that included memory deficit following cerebrovascular disease, atrial fibrillation, and chronic hypertension. The skilled nurse (SN) was to visit the patient once a week for 9 weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems and compliance with dietary and medication regimen. On 1/12/2023, at 12:05 p.m., during a home visit at Patient 6’s house with the DPCS, Patient 6 was observed alert and oriented, able to communicate with limitation (the patient was using non dominant language), and was ambulatory without using any assistive device. At 12:30 p.m., during a review of Patient 6's current medications compared with the medication profile provided by the agency, the following was observed: 1. Patient 6 had a bottle of Warfarin I mg to take three tablets everyday (dated 12/28/2022), while the medication record indicated to take three tablets once daily on Monday, Wednesday, Friday, Saturday, and Sunday (5 days). 2. Patient 6 had a bottle of Naproxen 220 mg – expired in March 2021. 3. The medication record indicated Patient 5 had Advil dual acetaminophen and Ibuprofen (250 mg/125 mg) one tablet twice daily as needed. However, Patient 5 did not have it at home. 4. Patient 6 had a bottle of Tylenol 500 mg, opened. During an interview with Patient 6, he stated he had used Tylenol after he bought over the counter. During an interview with the DPCS, on 1/13/2023, at 11 a.m., she stated the SN should have checked the patients’ medication record physically on each visit, and updated the medication record after clarification with the physician whenever there are discrepancies. A review of the agency’s undated policy and procedure titled “Medication Profile” indicated the patients receiving medications will have a current, accurate medication profile in the clinical record. The medication profile will be updated for each change to reflect current medications and new and/or discontinued medications. a. A review of Patient 1's clinical record indicated start of care (SOC) dated 6/21/22, with diagnoses that included non pressure chronic ulcer on right foot. A review of Patient 1's plan of care (POC) from 12/18/22 to 2/15/23, included an order for the skilled nurse (SN) to visit twice a week for nine weeks to assess nutritional status and competency with compliance with dietary and medication regimen. There were physician's order included in the POC to administer insulin as follows: a. Basaglar Kwikpen 100 unit/ml in 3 ml pen injector, to inject 18 units subcutaneous at bedtime. b. Regular insulin sliding scale, subcutaneously three times daily regular insulin sliding scale as follows: 150-200= 2 units, 201-250= 4 units, 251-300= 6 units,301-350= 8 units, 351-400= 10 units, 401-450= 12 units, above 451 call 911 or physician. On 1/12/23, at 11 a.m., during a joint home visit with Licensed Vocational Nurse (LVN) 1, Patient 1 was observed sitting on her couch with dressing on her right foot. During a review of Patient 1's medications indicated there were a Novolog Kwikpen 100 unit/ml in 3 ml pen injector and a Basaglar Kwikpen 100 unit/ml in 3 ml pen injector stored in the patient's refrigerator. On 1/12/23, at 12 p.m., during an interview with Patient 1, she stated she checks her blood sugar reading only during breakfast before she eats, and administers to herself Novolog insulin based on her blood sugar (BS) reading and given sliding scale orders. She also stated that she administers to herself Basaglar 26 units at bedtime. She further stated that her physician to increased her Basaglar insulin from 18 units to 26 units since 5 days ago. On 1/12/23, at 12:15 p.m., during an interview with LVN 1, he stated he was aware Patient 1 was only checking her BS reading during breakfast time before she eats and administer Novolog insulin per sliding but never notified the physician about it. He also stated that he did not ask or follow up with Patient 1 on how many units of Basaglar insulin she was taking lately during his visits. On 1/13/23, at 11 a.m., during an interview with DPCS (director of patient care services), she stated that LVN 1 should be checking and asking the patient regarding her medications during every visits and he should notify the agency and physician if there are drastic changes in regards to Patient 1's medication regimen. A review of the agency policy "Administration of Medication", indicated when there is a discrepancy in the medications, the nurse will contact the physician by telephone as soon as possible to verify the medication regimen. The nurse will instruct the patient and family in the correct medication regimen. The nurse will document all telephone conversations and instructions given to the patient and/or family in the patient clinical record.

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 observation, interview and record review, the Home Health Agency(HHA) failed to meet the Condition of Participation for Care Planning, Coordination Of Services, and Quality Of Care as follows: 1. The HHA failed to perform assessment of incision site on the right and left knees for one of seven sampled patients ( Patient 1) (Refer to G 572). 2. The HHA failed to include the acceptable parameters of vital signs (measurements of body's basic functions such as body temperature, pulse rate, respiration rate and blood pressure) in the Plan of Care (POC) for three of seven sampled patients (Patient 5, 6, 7) (Refer to G 574.) 3. The HHA failed to obtain new insulin medication order from the physician for one of seven sampled patients (Patient 1) (Refer to G 580). 4. The HHA failed to ensure the physician reviewed the plan of care (POC) timely for two of seven sampled patients (Patient 6, 7) (Refer to G 588). 5. The HHA failed to promptly notify the physician that a patient was not monitoring blood sugar level for one of seven sampled patients (Patient 1) (Refer to G 590). 6. The HHA failed to provide instruction regarding insulin medication management to the patient/ primary caregiver (PCG) for two of seven sampled patients (Patient 1, 5) (Refer to G 610). 7. The HHA failed to provide the written information of medications to the patient/PCG for two of seven sampled patients (Patient 5, 6) (Refer to G 616). The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care. .

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 agency staff failed to ensure care followed the written plan of care (POC) for one of seven sampled patients (Patient 1). Patient 1 had post operative incisions to the right and left knees following joint replacement. The visiting nurse failed to perform an assessment to the incision sites every visit as indicated in the POC. This deficient practice placed the patient at risk for delayed wound healing that could result in the decline and risk of infection to the incision sites. A review of Patient 1's clinical record indicated a Start of Care (SOC) date of 6/21/22, with diagnoses that included non-pressure chronic ulcer on the right foot. A review of Patient 1's plan of care (POC) from 12/18/22 to 2/15/23, included an order for the skilled nurse (SN) to visit twice a week for nine weeks, to assess all body systems and instruct the patient/primary caregiver on proper skin care to avoid new skin breakdown and infection. One of the SN intervention was to provide wound treatment to the right transmetatarsal (all or part of the foot) surgical wound as follows: to cleanse with Normal Saline, pat dry, apply Iodosorb ointment (medication to kill bacteria), cover with Betadine (antiseptic topical solution) soak gauze and wrap with Kerlix gauze and secure with tape. On 1/12/23, at 11 a.m., during a joint home visit with Licensed Vocational Nurse (LVN) 1, Patient 1 was observed sitting on her couch with a dressing on her right foot. The patient had a surgical wound at her right transmetatarsal foot. On 1/12/23, at 11:20 a.m., during an interview with Licensed Vocational Nurse 1 (LVN 1), he stated he does perform wound assessment during his visits. A review of Patient 1's LVN Visit Notes from dates 12/18/22 to 1/10/23, indicated there was no documented evidence the visiting nurse assessed the wound on Patient 1's right transmetatarsal of the foot during their visits. On 1/13/23, at 1 p.m., during an interview with the Director of Patient Care Services (DPCS), DPCS she stated LVN 1 should always do a wound assessment during his visits. A review of the agency's policy titled, "Wound Assessment", indicated during initial and follow-up nursing visits, any non-intact skin areas shall be assessed and document, and a complete measurement of the wound (length, width, depth) shall be documented during visits.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency staff failed to ensure the plan of care (POC) included acceptable vital signs (measurements of body's basic functions such as body temperature, pulse rate, respiration rate and blood pressure) parameters which would determine when to report to the physician to obtain further instruction for three of seven sampled patients (Patient 5, 6, 7). This deficient practice can allow the patients to have systemic distress. a. A review of Patient 5's plan of care (POC) for the certification period from 12/14/2022 to 2/11/2023, indicated a Start of Care (SOC) date of 4/18/2022, with diagnoses that included type 2 diabetes mellitus (DM - A chronic condition that affects the way the body processes blood sugar) and type 1 DM. The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment and observation and evaluation of all body systems. However, there were no vital sign parameters indicating when to notify the physician. On 1/12/2023, at 10:20 a.m., during a home visit at Patient 5’s house with the Director of Patient Care Services (DPCS), Patient 5 was observed alert and oriented, able to communicate well, and was ambulatory without using any assistive device. After the DPCS checked the patient’s vital signs, she stated the blood pressure was 166 mmHg/97 mmHg (Normal Range 120/80) and the pulse was 106 beats per minutes (Normal range 60-100 bpm). A review of the LVN Visit Notes dated 1/5/2023 indicated Patient 5’s blood pressure was 161 mmHg/93 mmHg (became 152 mmHg/92 mmHg after 30 minutes), but the heart rate was 107 beats per minutes. A review of the clinical record indicated there was no documented evidence the physician was notified regarding the patient’s high blood pressure and heart rate. b. A review of Patient 6's plan of care (POC) for the certification period from 11/13/2022 to 1/11/2023, indicated a Start of Care (SOC) dated 3/18/2022, with diagnoses that included memory deficit following cerebrovascular disease (group of conditions that affect blood flow and blood vessels in the brain), atrial fibrillation (irregular, often rapid heart rate that commonly causes poor blood flow) , and chronic hypertension (high blood pressure). The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems. However, there were no vital sign parameters indicating when to notify the physician. c. A review of Patient 7's plan of care (POC) for the certification period from 12/5/2022 to 2/2/2023, indicated a Start of Care (SOC) dated 10/6/2022, with diagnoses that included neoplasm related pain and muscle weakness. The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems. However, there were no vital signs parameters indicating when to notify the physician. A review of the agency’s policy and procedure titled, “Service Delivery Policy” indicated the patient’s physician will be contacted as follows: Systolic blood pressure: less than 90 mmHg or more than 160 mmHg. Diastolic blood pressure: less than 60 mmHg or more than 100 mmHg. Pulse rate: less than 60 beats per minutes, or more than 100 beats per minutes. During an interview with the DPCS on 1/13/2023, at 11:10 a.m., she stated the acceptable vital sign parameters should have been included in the POC to notify the abnormal vital signs to the physician for further instruction. A review of the agency’s undated “Plan of Care Policy” indicated the case manager and/or agency health professional staff member will notify the attending physician or the health professionals and responsible agency staff of significant changes in the patient’s condition that suggest the need to modify or develop a plan of treatment or plan of care.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to obtain a new insulin medication (used to treat number of diseases including diabetes, a group of diseases that result too much sugar in the blood) order for one out of seven sampled patients (Patient 1). This failure resulted in a medication error and had the potential to result in adverse health outcomes for Patient 1. A review of Patient 1's clinical record indicated a Start of Care (SOC) dated 6/21/22, with diagnoses that included non-pressure chronic ulcer on right foot. A review of Patient 1's plan of care (POC) from 12/18/22 to 2/15/23, included an order for the skilled nurse (SN) to visit twice a week for nine weeks to assess nutritional status and competency with compliance with dietary and medication regimen. There were physician's order included in the POC to administer insulin as follows: a. Basaglar Kwikpen 100 unit/ml in 3 ml pen injector, to inject 18 units subcutaneous at bedtime. b. Regular insulin sliding scale, subcutaneously three times daily regular insulin sliding scale as follows: 150-200= 2 units, 201-250= 4 units, 251-300= 6 units,301-350= 8 units, 351-400= 10 units, 401-450= 12 units, above 451 call 911 or physician. On 1/12/23, at 11 a.m., during a joint home visit with Licensed Vocational Nurse (LVN) 1, Patient 1 was observed sitting on her couch with dressing on her right foot. During a review of Patient 1's insulin medications indicated there were a Novolog Kwikpen 100 unit/ml in 3 ml pen injector and a Basaglar Kwikpen 100 unit/ml in 3 ml pen injector stored in the patient's refrigerator. On 1/12/23, at 12 p.m., during an interview with Patient 1, she stated that she administers to herself Basaglar 26 units at bedtime. She further stated that her physician told her to increase her Basaglar insulin from 18 units to 26 units since 5 days ago. On 1/12/23, at 12:15 p.m., during an interview with LVN 1, he stated that he did not ask or follow up with Patient 1 on how many units of Basaglar insulin she was taking lately during his visits. A further review of Patient 1's clinical record indicated no documented evidence the license nurses obtained a new order of Basaglar 26 units at bedtime for Patient 1. On 1/13/23, at 11 a.m., during an interview with DPCS (director of patient care services), she stated that LVN 1 should be checking and asking the patient regarding her medications during every visits.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure the physician reviewed/revised the plan of care (POC) in a timely manner for two of seven sample patients (Patient 6 and 7). This deficient practice had the potential for not providing appropriate care the patient needed. a. A review of Patient 6's plan of care (POC) for the certification period from 11/13/2022 to 1/11/2023, indicated a Start of Care (SOC) dated 3/18/2022, with diagnoses that included memory deficit following a cerebrovascular disease, atrial fibrillation, and chronic hypertension. The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems. There were spaces in the POC for the physician’s signatures and date. However, there were no signatures and dates. b. A review of Patient 7's plan of care (POC) for the certification period from 12/5/2022 to 2/2/2023, indicated a Start of care (SOC) dated 10/6/2022, with diagnoses that included neoplasm related pain and muscle weakness. The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems. However, the spaces for the signatures of the physician and dates were blank. During an interview with the Director of Patient Care Services (DPCS) on 1/13/2023, at 11:40 a.m., she stated she was not able to provide the documented evidence the physician had reviewed Patient 6’s POC (from 11/11/2022 to 1/11/2023) and Patient 7’s POC (from 12/5/2022 to 2/22/2023). A review of the agency’s undated “Plan of Care Policy” indicated the Plan of Care is signed, and dated by the patients’ physician within 30 working days from the start of care date but prior to the re-certification date.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the licensed vocational nurse (LVN) failed to notify the physician promptly while a patient was not checking her BS (blood sugar) readings and administering sliding scale for insulin medication (used to treat number of diseases including diabetes, a group of diseases that result too much sugar in the blood) as ordered during visits for one out of seven sampled patients (Patient 1). This deficient practice placed patients at a potential risk for complications that could affect their overall health status. A review of Patient 1's clinical record indicated a Start of Care (SOC) date of 6/21/22, with diagnoses that included non-pressure chronic ulcer on right foot. A review of Patient 1's plan of care (POC) from 12/18/22 to 2/15/23, included an order for the skilled nurse (SN) to visit Patient 1 twice a week for nine weeks to assess nutritional status and competency with compliance with dietary and medication regimen. There were physician's order included in the POC to administer insulin as follows: a. Basaglar Kwikpen 100 unit/ml in 3 ml pen injector, to inject 18 units subcutaneous at bedtime. b. Regular insulin sliding scale, subcutaneously three times daily regular insulin sliding scale as follows: 150-200= 2 units, 201-250= 4 units, 251-300= 6 units,301-350= 8 units, 351-400= 10 units, 401-450= 12 units, above 451 call 911 or physician. On 1/12/23, at 11 a.m., during a joint home visit with Licensed Vocational Nurse (LVN) 1, Patient 1 was observed sitting on her couch with dressing on her right foot. During a review of Patient 1's medications indicated there were a Novolog Kwikpen 100 unit/ml in 3 ml pen injector and a Basaglar Kwikpen 100 unit/ml in 3 ml pen injector stored in the patient's refrigerator. On 1/12/23, at 12 p.m., during an interview with Patient 1, she stated she checks her blood sugar reading only during breakfast before she eats, and administers to herself Novolog insulin based on her blood sugar (BS) reading and given sliding scale orders. She also stated that she administers Basaglar 26 units at bedtime to herself. On 1/12/23, at 12:15 p.m., during an interview with LVN 1, he stated he was aware Patient 1 was only checking her BS reading during breakfast time before she eats and administer Novolog insulin per sliding and she does not check her BS or administer to herself the Novolin insulin per sliding scale during lunch and dinner time. He also stated that he did not notify the physician about it. On 1/13/23, at 11 a.m., during an interview with DPCS (director of patient care services), she stated that LVN 1 should be checking and asking the patient regarding her medications during every visits and he should notify the agency and physician if there are drastic changes in regards to Patient 1's medication regimen. A review of the agency policy titled, "Administration of Medication", indicated when there is a discrepancy in the medications, the nurse will contact the physician by telephone as soon as possible to verify the medication regimen. The nurse will instruct the patient and family in the correct medication regimen. The nurse will document all telephone conversations and instructions given to the patient and/or family in the patient clinical record.

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) skilled nurse (SN) failed to provide instruction regarding opened Novolog insulin (rapid acting insulin that helps lower mealtime blood sugar spikes) which expires 28 days after it was opened, and failed to provide education/instruction about the correct use of the glucometer (portable machine that is used to measure how much sugar in the blood) for two of seven sampled patients (Patient 1 and 5). This deficient practice could cause the patient to use insulin medication which was expired and result in incorrect blood sugar readings that could cause a potential risk of hyperglycemia (an excess of glucose in the bloodstream)/hypoglycemia (deficiency of glucose in the bloodstream). a.A review of Patient 5's plan of care (POC) for the certification period from 12/14/2022 to 2/11/2023, indicated start of care (SOC) dated 4/18/2022, with diagnoses that included type 2 Diabetes Mellitus (DM - A chronic condition that affects the way the body processes blood sugar) and type 1 DM. The skilled nurse (SN) was to visit the patient once a week for 9 weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems. The POC included the physician's order of Novolog Flex pen insulin subcutaneous three times a day per sliding scale daily as follows: 150 milligram (mg)/deciliter (dl) to 200 mg/dl =2 units 201 mg/dl to 250 mg/dl =4 units 251 mg/dl to 300 mg/dl =6 units 301 mg/dl to 350 mg/dl = 8 units 351 mg/dl to 400 mg/dl = 10 unit 401 mg/dl to 450 mg/dl = 12 unit On 1/12/2023, at 10:20 a.m., during a home visit at Patient 5’s house with the Director of Patient Care Services (DPCS), Patient 5 was observed alert and oriented, able to communicate well, and was ambulatory without using any assistive device. At 11:40 a.m., during a review of Patient 5's current medications compared with the medication profile provided by the agency, a Novolog insulin Flex pen was observed opened, but not labeled with an opened date. During an interview with the patient at the same time, he stated he did not remember exactly when it was opened. He stated nobody instructed him about how long the insulin was okay to be used after it was first opened, and nobody instructed to label it with the opened date. On 1/13/2023, at 11:10 a.m., during an interview with the DPCS, she stated Novolog Flex pen is good for 28 days after it was opened and the patient/primary caregiver should have been instructed that and to label the Novolog Flex pen with the opened date. A review of the reference provided by the agency (Children’s Hospital, Michigan Medicine) indicated open or in-use pens should be kept at room temperature for a maximum of 28 days, and after 28 days, Novolog FlexPens should be thrown away in the trash even if there is left over insulin. b. On 1/12/2023, At 11:35 a.m., Glucometer 1 was observed at Patient 5’s house. During an interview with Patient 5, he stated Glucometer 1 was new (he stated he got Glucometer 1 approximately 2 months ago), and he had not calibrated/control solution tested Glucometer 1 because he was not provided instruction from anybody to do so. Patient 5 also stated he did not even know where the control solution was. During an interview with the DPCS, she stated Glucometer 1 needed control solution test/calibration, and the SN should have instructed Patient 5 to do control solution test/calibration. A review of the “Professional Monitoring blood Glucose System” for Glucometer 1 indicated to perform a control test as follows: · * Before using the system for the first time. · * For practice to ensure that testing technique is good. · * When opening a new vial of test strips. · * If results seem unusually high or low based on the patient’s condition A review of Patient 1's clinical record indicated start of care (SOC) dated 6/21/22, with diagnoses that included non pressure chronic ulcer on right foot. A review of Patient 1's plan of care (POC) from 12/18/22 to 2/15/23, included an order for the skilled nurse (SN) to visit twice a week for nine weeks to assess nutritional status and competency with compliance with dietary and medication regimen. There were physician's order included in the POC to administer insulin as follows: a. Basaglar Kwikpen 100 unit/ml in 3 ml pen injector, to inject 18 units subcutaneous at bedtime. b. Regular insulin sliding scale, subcutaneously three times daily regular insulin sliding scale as follows: 150-200= 2 units, 201-250= 4 units, 251-300= 6 units,301-350= 8 units, 351-400= 10 units, 401-450= 12 units, above 451 call 911 or physician. On 1/12/23, at 11 a.m., during a joint home visit with Licensed Vocational Nurse (LVN) 1, Patient 1 was observed sitting on her couch with dressing on her right foot. During a review of Patient 1's medications indicated there were a Novolog Kwikpen 100 unit/ml in 3 ml pen injector and a Basaglar Kwikpen 100 unit/ml in 3 ml pen injector stored in the patient's refrigerator. On 1/12/23, at 12 p.m., during an interview with Patient 1, she stated she checks her blood sugar reading only during breakfast before she eats using her glucometer. When patient was asked if the visiting nurse had instructed on how to calibrate her glucometer, she stated she was not aware that her glucometer needed to be calibrated. On 1/12/23, at 12:10 p.m., during an interview with LVN 1, he stated he did not check if patient's glucometer needs to be calibrated or not. On 1/13/23, at 1 p.m., during an interview with the director of patient care services, she stated LVN 1 should first find out if his patient's glucometer needs to be calibrated and if does, he needs to to patient teaching for glucometer care.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to provide written information on the medications to the patient/caregiver, including the side effects of the medications that patients were taking for two of seven sampled patients (Patient 5, 6). This deficient practice had the potential to result in the medication information not being available to the patients/caregivers when needed. a. A review of Patient 5's plan of care (POC) for the certification period from 12/14/2022 to 2/11/2023, indicated a Start of Care (SOC) dated 4/18/2022, with diagnoses that included type 2 diabetes mellitus (DM - A chronic condition that affects the way the body processes blood sugar) and type 1 DM. The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems and compliance with dietary and medication regimen. On 1/12/2023, at 10:20 a.m., during a home visit at Patient 5’s house with the Director of Patient Care Services (DPCS), Patient 5 was observed alert and oriented, able to communicate well, and was ambulatory without using any assistive device. Family member 1 was next to the patient. At 11 a.m., Patient 5's current medications were compared with the medication profile provided by the agency. A review of the medication profile indicated there was no side effects included in it. During an interview with the patient at the same time, Patient 5 stated he knew what his medications are for, but did not know the side effects of the medications. When asked, Patient 5 stated he was not provided the written instruction about his medications including action and side effects of the medication by the agency. During an interview with the DPCS at the same time, she was not able to locate the written instruction including the side effects of Patient 5’s medications, was provided to Patient 5/Primary caregiver. b. A review of Patient 6's plan of care (POC) for the certification period from 11/13/2022 to 1/11/2023, indicated a Start of Care (SOC) dated 3/18/2022, with diagnoses that included memory deficit, cerebrovascular disease (group of conditions that affect blood flow and blood vessels in the brain), atrial fibrillation (irregular, often rapid heart rate that commonly causes poor blood flow), and chronic hypertension (high blood pressure). The skilled nurse (SN) was to visit the patient once a week for nine weeks. The SN was to monitor and record vital signs, perform skilled nursing assessment, observation and evaluation of all body systems and compliance with dietary and medication regimen. On 1/12/2023, at 12:05 p.m., during a home visit at Patient 6’s house with the DPCS, Patient 6 was observed alert and oriented, able to communicate with limitation (the patient was mostly using non dominant language), and was ambulatory without using any assistive device. At 12:30 p.m., Patient 6's current medications were checked compared with the medication profile provided by the agency. Upon attempting an interview with the patient at the same time, it was noticed Patient 6 had limitation communicating using dominant language. A review of the medication profile indicated there was no side effects included in it. A review of the agency’s folder in Patient 6’s house, was documented in dominant language, not Patient 6’s language. During an interview with the DPCS, on 1/13/2023, at 11:10 a.m., she stated written information regarding the medication regimen including side effects should have been provided to the patient. A review of the agency’s undated policy and procedure titled “Medication Profile” indicated a drug regimen review will be performed at the time of admission and a copy will be provided to Patient. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicate drug therapy, and noncompliance with drug therapy omissions and unclear information.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. 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 Quality Assessment and Performance Improvement (QAPI) program as follows: The HHA failed to ensure the QAPI program was developed based upon identified or negative patient care outcomes, measurable indicators to evaluate changes in policy, procedure, and intervention (Refer to G 642). The HHA failed to conduct performance improvement (Refer to G 644). The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care. .

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview, and record review, the home health agency failed to provide documented evidence of a Quality Assessment and Performance Improvement (QAPI) program based upon identified or negative patient care outcomes, measurable indicators to evaluate changes in policy, procedure, and intervention. This failure has the potential to result in the HHA not being able to assess and evaluate negative patient care outcomes, and infection control program surveillance, including the HHA's operations. During record review of the Quality Assessment and Performance Improvement (QAPI) program on 1/13/23, at 12:45 p.m., it indicated the QAPI program policy was not approved and implemented since 1/15/20. The policy indicated the program will objectively and systematically monitor and evaluate the effectiveness and safety of services and quality of care provided for patient/families. Further review indicated there was no documented evidence data were collected to assess, evaluate, in order to improve patients' quality of care. During the interview on 1/13/23, at 12:50 p.m., DPCS 1 (Director of patient care services) could not provide evidence that data were collected and QAPI meetings occurred. DPCS 1 confirmed the policy should be reviewed annually and there should be evidence of a functioning QAPI program. DPCS 1 also confirmed she could not provide any current documentation, and stated that QAPI program is important to improve operations.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency failed to provide documented evidence of performance improvement projects. This failure had the potential to affect the quality of care being provided to the patients. During a record review on 1/13/23, at 12 p.m., the agency had no documented evidence that performance improvement projects, either in development, on-going or completed were conducted or performed. During an interview with on 1/13/23, at 12:10 p.m., DPCS 1 (Director of patient care services) stated she had not started on the projects and could not provide any documentation. The agency's policy and procedure, titled, "Patient Focused Performance Improvement", indicated program related to performance improvement activities will focus on opportunities to improve overall organizational performance.

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 skilled nurse (SN) failed to wash and sanitize his hands after removing his gloves that touched soiled a dressing, and prior to providing wound care for one of of seven sampled patients (Patient 1). This deficient practice placed the patient at a potential risk for a delay in wound healing, or the potential to cause a wound infection. A review of Patient 1's clinical record indicated a Start of Care (SOC) date of 6/21/22, with diagnoses that included non-pressure chronic ulcer on the right foot. A review of Patient 1's plan of care (POC) from 12/18/22 to 2/15/23, included an order for the skilled nurse (SN) to visit twice a week for nine weeks to assess all body systems and instruct the patient/primary caregiver on proper skin care to avoid new skin breakdown and infection. One of the SN intervention was to provide wound treatment to the right transmetatarsal surgical wound as follows: to cleanse with Normal Saline, pat dry, apply Iodosorb ointment, cover with Betadine soak gauze and wrap with Kerlix and secure with tape. On 1/12/23, at 11 a.m., during a joint home visit with Licensed Vocational Nurse (LVN) 1, Patient 1 was observed sitting on her couch with a dressing on her right foot. During a wound care observation on 1/12/23, at 11:20 a.m., LVN 1 washed his hands and put on new gloves, then removed the old dressing on Patient 1's right foot. The dressing was observed soiled with crust particles. LVN 1 cleaned the surgical wound on the right transmetatarsal with 4 x 4 gauze wet with normal saline, applied Iodosorb ointment, then covered with Betadine soak gauze, wrapped with Kerlix and secured with tape without removing his soiled gloves and washing his hands. On 1/12/23, at 11:50 a.m., during an interview with LVN 1, he stated he was so nervous that he forgot to remove his soiled gloves and wash his hands after removing the soiled dressing. On 1/13/23, at 1 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated, "LVN 1 should have washed or sanitized his hands after removing the gloves that touched the soiled dressing." A review of the agency's policy of "Hand Washing", indicated all home healthcare personnel will wash their hands before and after contact with each patient and anytime their hands become soiled.