Every finding on record at Care Unlimited Health Services, Inc.

The following reflects the findings of the California Department of Public Health during a Recertification Survey at this location: 1025 WEST ARROW HIGHWAY SUITE 105 GLENDORA, CA 91740 Representing the California Department of Public Health: Health Facilities Evaluator Nurse, Surveyor ID: 36459 Health Facilities Evaluator Nurse, Surveyor ID: 22303 Health Facilities Evaluator Nurse, Surveyor ID: 44916 Unduplicated Admissions - 58 Active Patients - 15 Sample Size - 7 Home Visits- 3 The following Conditions of Participation was not met: 484.60 Care Planning, Coordination, Quality of Care

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to review and document medication changes for one of seven sampled patients (Patients 1). This deficient practice had the potential to place patients at risk for drug interactions, adverse actions, and medication errors that could affect the patients already compromised health status. A review of Patient 1's clinical record indicated a Start of Care date (SOC) of 12/31/2022, with a diagnosis of type 2 diabetes mellitus (DM) (impairment in the way the body controls and uses sugar) and a foot ulcer (open sores or lesions that will not heal or that return over a long period of time). A review of Patient 1's Plan of Care (POC) for the certification period of 12/31/2022 to 2/28/2023, indicated a skilled nurse (SN) was scheduled to visit the patient three times a week for eight weeks. The POC further indicated to conduct a Physical Therapy (PT) evaluation for the week of 1/1/2023. On 2/1/2023, at 11:00 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. A review of Patient 1’s Medication Profile provided by the agency, indicated Patient 1 had two orders listed for Losartan Potassium HCTZ (Hydrochlorothiazide- used to treat high blood pressure) 100-25 milligram (mg – unit of measurement), one tablet once daily and Carvedilol (used to treat high blood pressure and heart failure) 25 mg one tablet two times a day. During an interview with Patient 1 on 2/1/2023, at 11:35 a.m., he stated six months ago he started taking only one tablet of the Losartan Potassium HCTZ instead of two tablets and his physician was the one who changed it. Patient 1 further stated six months ago he also started taking Carvedilol once a day instead of twice a day and his physician was the one who changed it as well. Patient 1 further stated when Registered Nurse 1 (RN 1) came to do a home visit on Sunday 01/31/2023 she did not check or ask about his medications. During an interview with Licensed Vocational Nurse 1 (LVN 1) on 2/1/2023, at 11:55 a.m., she stated she checks medications once a week or every other week. During an interview with the Director of Patient Care Services Designee (DPCSD) on 2/2/2023 at 12:04 p.m., he stated medication reconciliation should be performed and checked every visit. A review of the agency’s policy and procedure titled “Medication Profile,” dated 11/2021, indicated medication profiles will be updated for each change to reflect the current medications, new, and/or discontinued medications. The policy and procedure further indicated the drug regimen review will be performed at the time of admission, when updates to the comprehensive assessment are performed, when care is resumed after the patient has been placed on hold, and with the addition of a new medication.

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 ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The HHA failed to follow the plan of care (POC) for one of seven sampled patients (Patient 2). (Refer G572) 2. The HHA failed to obtain a physician order for two of seven sampled patients (Patient 2 and Patient 6). (Refer to G580) 3. The HHA failed to ensure that there was a coordination of care and services for two of seven sampled patients (Patient 1 and Patient 3). (Refer to G600) 4. The HHA failed to ensure that patient/primary caregiver (PCG) were instructed and educated about insulin medication and glucometer machine for three of seven sampled patients (Patient 1, Patient 3 and Patient 6). (Refer to G610) The cumulative effect of these systemic practices resulted in the home health agency's failure to ensure the plan of care was followed to reach patient goals. .

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 follow the plan of care (POC) to provide round the clock care as ordered for one of seven sampled patients (2). This deficient practices resulted in the patient not receiving the quality of care and services identified in the POC. A review of Patient 2's clinical record indicated a Start of Care date (SOC) of 9/21/2020, with a diagnosis of Parkinson's disease (brain disorder that causes unintended or uncontrollable movements). A review of Patient 2's Plan of Care (POC) for the certification period of 11/15/2021 to 1/13/2022, indicated a Licensed Vocational Nurse (LVN) was ordered 24 hour round the clock skilled shift care. A review of Patient 2’s clinical records indicated on 11/20/2021, 11/21/2021, 11/22/2021, 11/27/2021, 11/28/2021, 12/03/2021, 12/05/2021, 12/18/2021, 12/26/2021, 01/02/2022, 01/08/2022 and 01/09/2022 an LVN was not provided round the clock as ordered. During an interview with the Director of Patient Care Services Designee (DPCSD) on 2/02/2023 at 12:19 p.m., he stated Patient 2 had around the clock LVN services ordered. DPCSD further stated Patient 2 was difficult and there were times when there was no LVN available to take care of the patient. A review of the agency’s policy and procedure titled “Care Planning Process,” dated 11/2021, indicated the plan of care will be based upon the physician’s order and will encompass the equipment, supplies, and services required to meet the patient’s needs.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to obtain a physician order for two of seven sampled patients (Patient 2 and Patient 6). Patient 2 did not have an order for a Certified Home Health Aide (CHHA) Patient 6 did not have an order to apply Silver Alginate dressing to the patient's open wound. The deficient practice resulted in patients receiving services that were not ordered by a physician and had the potential to result in harm and injury. A review of Patient 6’s clinical record titled, “Home Health Certification and Plan of Care”, for certification period 12/9/22 to 2/6/23, indicated a Start of Care date of 2/12/22, with a diagnosis that included non pressure chronic ulcer of other part of right foot. The POC indicated the Skilled Nurse (SN) was to visit Patient 6 twice a week for four weeks, twice a week for four weeks, to perform skilled observation and assessment of vital sign and all body systems and medication/dietary regimen. The SN was to perform wound care to right plantar second metatarsal head as follows: cleanse with normal saline, pat dry, apply Silver Alginate to wound, cover with 4x4 gauze, wrap with stretch gauze and tape to secure. On 2/1/23, at 10 a.m., a home visit was conducted at Patient 6's residence with RN 6. Patient 6 was alert and oriented, sitting on his couch in the living room. At 10:15 a.m., RN 6 was observed removing the soiled dressing at patient's right foot. Patient 6 had a bruise/dead toe nail at his right foot third toe nail. A review of Patient 6's Skilled Nurse Visit notes dated 12/12/22, indicated the visiting nurse provided wound care and she applied Aquacel AG dressing to the open wound at right foot. On 2/3/23, at 1 p.m., during an interview with the DPCSD (director of patient care services designee), he stated the visiting nurse should have followed the standing order to apply Silver Alginate dressing on the wound as ordered. Findings: a. A review of Patient 2's clinical record indicated a start of care date (SOC) of 09/21/2020, with diagnosis of parkinson’s disease (brain disorder that causes unintended or uncontrollable movements). A review of Patient 2's Plan of Care (POC) for the certification periods of 07/18/2021 to 09/15/2021, 09/16/2021 to 11/14/2021 and 11/15/2021 to 01/13/2022, indicated that a Licensed Vocational Nurse (LVN) was ordered 24 hour round the clock skilled shift care. The POCs did not indicate that a CHHA was ordered. A review of Patient 2’s clinical records indicated that there was CHHA notes from 07/2021 to 01/2022 by CHHA 1. During an interview with the Director of Patient Care Services Designee (DPCSD) on 02/02/2023 at 2:42 p.m., he stated that a LVN was unable to stay with the patient so the agency looked for someone available and that is when they found CHHA 1. DPCSD further stated that Patient 2 did not have orders for CHHA services and only had orders for around the clock LVN. A review of the agency’s policy and procedure titled “Physician Participation in Plan of Care,” dated 11/2021, indicated that a physician (or other authorized licensed independent practitioner) will direct the care of every home health care patient admitted for service. The attending physician (or other authorized licensed independent practitioner) will certify that medical, skilled, rehabilitative and social services provided by the organization are medically necessary and meets the requirements to be covered by medicare. The policy and procedure further indicated that the care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practices.

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 visiting nurse failed to notify the physician promptly regarding a patient with a newly identified right foot third toe nail bruise for one out of seven patients (Patient 6). This deficient practice had the potential to result in complications. A review of Patient 6’s clinical record titled, “Home Health Certification and Plan of Care”, for certification period 12/9/22 to 2/6/23, indicated a Start of Care date of 2/12/22, with a diagnosis that included non pressure chronic ulcer of other part of right foot. The POC indicated the Skilled Nurse (SN) was to visit Patient 6 twice a week for four weeks, twice a week for four weeks, to perform skilled observation and assessment of vital sign and all body systems and medication/dietary regimen. The SN was to perform wound care to the right plantar second metatarsal head as follows: Cleanse with normal saline, pat dry, apply Silver Alginate to the wound, then cover with a 4x4 gauze, wrap with stretch gauze and tape to secure. On 2/1/23, at 10 a.m., a home visit was conducted at Patient 6's residence with RN 6. Patient 6 was alert and oriented, sitting on his couch in the living room. At 10:15 a.m., RN 6 was observed removing the soiled dressing on Patient 6's right foot. Patient 6 had a bruised/dead toe nail on his third toe on the right foot. At 10:20 a.m., during an interview with Patient 6, he stated he noticed he had a bruised/dead nail on his third toe on the right foot for three days now. He also stated he probably got it from wearing his tight boot. At 10:30 a.m., during an interview with RN 6, she stated that was the first time she saw the patient's bruised/dead toe nail but she would report it to the physician right away because the patient is diabetic. On 2/3/23, at 11 a.m., a further review of Patient 6's clinical record indicated there was no documented evidence the visiting nurse promptly notified the physician regarding the newly identified bruised/dead toe nail on the third toe of the patient's right foot. On 2/3/23, at 12 p.m., during an interview with the DPCSD (Director of patient care services designee), he stated the visiting nurse should have notified the physician of Patient 6's dead/bruised toe nail of the right foot promptly. A review of the agency's undated policy "Change of Condition", indicated the clinician is responsible for any specific treatment and would notify the attending physician of significant changes in the patient's condition.

Coordination of Care CFR(s): 484.60(d) Standard: Coordination of care. The HHA must: This STANDARD is not met as evidenced by: Based on observation, interview and record review, the HHA failed to ensure there was a coordination of care and services for two of seven sampled patients (Patient 1 and Patient 3). This deficient practice had potential to delay services included in the plan of care. A review of Patient 3's clinical record disclosed a start of care dated 8/23/22, with diagnoses which included gangrene (the death of tissue often occurs in the extremities or skin from loss of blood supply. The condition often affects toes, fingers, and limbs, but can affect muscles and organs. Symptoms include discolored skin, severe pain followed by numbness, and foul discharge. Gangrene requires urgent care. Treatment includes antibiotics and removing dead tissue) and Type 2 diabetes mellitus (high blood sugar for prolonged period). A review of Patient 3's plan of care (POC) for the certification period of 12/21/22 through 2/18/23, included orders for the skilled nurse (SN) to visit every other day for 23 days till 1/13/23 and 2 times a week staring 1/15/23 for five weeks plus 3 PRN("pro re nata" or as needed)for wound complications. SN to continue to perform skilled evaluation, observation, assessment of patient other complications of procedures, gangrene, for change and removal of surgical wound dressing, chronic post procedural pain, peripheral vascular disease, type 2 diabetes with diabetic neuropathy, status post right transmetatarsal amputation for signs and symptoms of infection, healing status, response to prescribed wound care treatment, essential hypertension, hyperlipidemia, insomnia, kidney transplant, compliance with medication and diet regimen, infection control measures, knowledge/observance of home safety, response to treatment/medications, disease complications/exacerbations, drug adverse reactions, ineffective drug regimen. SN to continue to instruct patient/caregiver per knowledge deficit identified on the disease processes, signs and symptoms, management, prevention, risk factors, complications, medications dose therapeutic actions, adverse effects, precautions for high risk medications, infection control measures/management, other significant change in condition. Wound management to be performed by SN during scheduled visits and caregiver on the days with no SN visits as follows: Cleanse right metatarsal amputation surgical site with normal saline or wound wash , pat dry and apply Iodoflex (is used for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic ulcers, particularly when infection is present or suspected to open wound areas), painted eschar (is a collection of dry, dead tissue within a wound) with betadine, cover with dry gauze, wrapped with kerlix and secured with tape. On 2/1/23 at 12:00 p.m., during a joint home visit with Licensed Vocational Nurse 2 (LVN 2), Patient was observed lying in a bed, with Family Member 1 next to the patient. LVN 2 proceeded with his visit. During an interview with Family member 1 during the joint home visit on 2/1/23, Family member 1 stated "I did not know that the home health can provide us with the wheelchair. I was calling the social worker from the hospital he was previously discharged. No wonder they told me they cannot help me with it." During an interview with the Director of Patient Care Designee on 2/2/23 at 11:45 a.m., DPCS designee stated the importance of the skilled nurse to educate the patient and their family members of the services that the agency can provide to their patients every visit. A review of the HHA's policy titled "Care/Service Coordination" revised November 2021, indicated the purpose is to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting or duplicated services. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. Findings: a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 12/31/2022, with diagnosis of type 2 diabetes mellitus (DM) (impairment in the way the body controls and uses sugar) with foot ulcer (open sores or lesions that will not heal or that return over a long period of time). A review of Patient 1's Plan of Care (POC) for the certification period of 12/31/2022 to 02/28/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient three times a week for eight weeks. The POC further indicated Physical Therapy (PT) evaluation for the week of 01/01/20203. On 02/01/2023, at 11:00 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. During an interview with Patient 1 on 02/01/2023, at 11:20 a.m., he stated that he has not received PT yet. Patient 1 stated that last month PT came to do an evaluation and that afterwards he and the PT kept missing each other. Patient 1 stated that he called the PT but couldn’t get a hold of the person and that he will try calling PT again to schedule something. Patient 1 further stated that when Registered Nurse 1 (RN 1) came for a visit on Sunday, he mentioned to her about how he kept missing PT. Patient 1 stated that RN 1 did not say anything and that there was no follow-up afterwards. Patient 1 stated that he was unaware that he could contact the agency regarding PT. A review of Patient 1’s PT Evaluation dated 01/01/2023, indicated that a frequency of once a week for one week, then two times a week for five week and then once a week for one week with a start date of 12/31/2022 and end date of 02/28/2022. A review of Patient 1’s Missed Visit form indicated that there was missed visits for PT on 01/11/2023, 01/12/202023, 01/17/2023 and 01/19/2023. A review of Patient 1’s Physician Order dated 01/19/2023, indicated that PT was cancelled due to patient not answering the phone or responding to text messages and that agency is aware. During an interview with the Director of Patient Care Services Designee (DPCSD) on 02/02/2023 at 12:04 p.m., he stated that when nurses go to visit the patients they should find out if other disciplines ordered are going and that if patient need other services. DPCSD further stated that Patient 1’s PT should have been followed up on to make sure that he was receiving the services.

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 the patient and primary caregiver (PCG) were instructed and provided education regarding insulin medication and the glucometer machine for three of seven sampled patients (Patient 1, Patient 3 and Patient 6). This deficient practice had the potential to result in using outdated medication, lessen effectiveness of medication and not acquiring correct blood sugar (BS) readings while using the glucometer. A review of Patient 6’s clinical record titled, “Home Health Certification and Plan of Care”, for certification period 12/9/22 to 2/6/23, indicated a Start of Care date of 2/12/22, with a diagnosis that included non pressure chronic ulcer of other part of right foot. The POC indicated the Skilled Nurse (SN) was to visit Patient 6 twice a week for four weeks, twice a week for four weeks, to perform skilled observation and assessment of vital sign and all body systems and medication/dietary regimen. One of the SN interventions was to teach patient/caregiver in blood glucose monitoring and how to perform how to use the glucometer the proper way. On 2/1/23, at 10 a.m., a home visit was conducted at Patient 6's residence with RN 6. Patient 6 was alert and oriented, sitting on his couch in the living room. At 10:15 a.m., RN 6 was observed removing the soiled dressing at patient's right foot. Patient 6 had a bruise/dead toe nail at his right foot third toe nail. when asked if patient calibrates his glucometer, he stated no, the visiting nurse did not check if my glucometer needs to be calibrated or not. A further review of Patient 6's clinical record indicated no documented evidence the visiting nurse provided patient teaching on glucometer usage with a return demonstration by the patient/caregiver to validate teaching. On 2/3/23, at 12 p.m., during an interview with the DPCSd (director of patient care services designee), he stated the visiting nurse should be teaching regarding glucometer usage and patient/caregiver should do a return demonstration to the visiting nurse to show proper way and to validate the teaching. A review of the agency's policy "Patient Education" indicated the agency should educate patients about their disease process, care plan and treatments while on service. A review of Patient 3's clinical record disclosed a start of care dated 8/23/22, with diagnoses which included gangrene (the death of tissue often occurs in the extremities or skin from loss of blood supply. The condition often affects toes, fingers, and limbs, but can affect muscles and organs. Symptoms include discolored skin, severe pain followed by numbness, and foul discharge. Gangrene requires urgent care. Treatment includes antibiotics and removing dead tissue) and Type 2 diabetes mellitus (high blood sugar for prolonged period). A review of Patient 3's plan of care (POC) for the certification period of 12/21/22 through 2/18/23, included orders for the skilled nurse (SN) to visit every other day for 23 days till 1/13/23 and 2 times a week staring 1/15/23 for five weeks plus 3 PRN("pro re nata" or as needed)for wound complications. SN to continue to perform skilled evaluation, observation, assessment of patient other complications of procedures, gangrene, for change and removal of surgical wound dressing, chronic post procedural pain, peripheral vascular disease, type 2 diabetes with diabetic neuropathy, status post right transmetatarsal amputation for signs and symptoms of infection, healing status, response to prescribed wound care treatment, essential hypertension, hyperlipidemia, insomnia, kidney transplant, compliance with medication and diet regimen, infection control measures, knowledge/observance of home safety, response to treatment/medications, disease complications/exacerbations, drug adverse reactions, ineffective drug regimen. SN to continue to instruct patient/caregiver per knowledge deficit identified on the disease processes, signs and symptoms, management, prevention, risk factors, complications, medications dose therapeutic actions, adverse effects, precautions for high risk medications, infection control measures/management, other significant change in condition. Wound management to be performed by SN during scheduled visits and caregiver on the days with no SN visits as follows: Cleanse right metatarsal amputation surgical site with normal saline or wound wash , pat dry and apply Iodoflex (is used for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic ulcers, particularly when infection is present or suspected to open wound areas), painted eschar (is a collection of dry, dead tissue within a wound) with betadine, cover with dry gauze, wrapped with kerlix and secured with tape. On 2/1/23 at 12:00 p.m., during a joint home visit with Licensed Vocational Nurse 2 (LVN 2), Patient was observed lying in a bed, with Family Member 1 next to the patient. LVN 2 proceeded with his visit. On 2/1/23 at 12:30 p.m., during the review of Patient 3's medication, observed that Patient 3's Basaglar insulin (is a long-acting basal insulin used to control high blood sugar in adults) kwikpen (a prefilled syringe) and Novolog insulin (a rapid-acting insulin that helps lower mealtime blood sugar spikes in adults with diabetes) were not labeled when they were first opened. On concurrent interview with the patient's caregiver stated that she did not know she needed to label the date when she first opened the insulin kwikpens. On both insulin kwikpen manufacturer's instructions, indicated to discard unused portion of the pen 28 days after first opening. Store in-use pen at room temperature up to 86 degrees Fahrenheit ( unit of temperature) or 30 degrees Celsius (unit of temperature). Protect from light. There were no documentation from the caregiver and the SN when it was first opened. On 2/1/23 at 12:30 p.m., during an interview with LVN 2, stated that he should have educated the caregiver to write the date when she first used the insulin kwikpens. LVN 2 also stated the importance of putting the dates to monitor the effectiveness and viability of the insulin for patient use. On 2/2/23 at 11:45 a.m., during an interview with the Director of Patient Care Services designee (DPCS designee), stated that nurses are expected to provide health and medication teaching to patients and caregivers every visit. A review of the HHA's policy titled " Patient Education Process" revised November 2021, indicated patients and family/caregivers will receive education in verbal, visual and written format as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences and readiness to learn of the patient and family/caregiver, as well as by the plan of care. Education will be the responsibility of each clinician and will focus on facilitating the patient's and family/caregiver's understanding of his/her health status. health care options and consequences of options. The clinician will assess, plan, implement, and evaluate the following on each patient and caregiver, as appropriate: the pertinent information needed by the patient and caregiver in relation to the care being rendered, safe and effective use of equipment and supplies . The patient's and family/caregivers knowledge, skills, and behaviors will be assessed during home visits through an interactive process. Reinforcement of instruction will be provided as needed. Findings: a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 12/31/2022, with diagnosis of type 2 diabetes mellitus (DM) (impairment in the way the body controls and uses sugar) with foot ulcer (open sores or lesions that will not heal or that return over a long period of time). A review of Patient 1's Plan of Care (POC) for the certification period of 12/31/2022 to 02/28/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient three times a week for eight weeks. The POC further indicated Physical Therapy (PT) evaluation for the week of 01/01/20203. On 02/01/2023, at 11:00 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. A review of Patient 1’s Medication Profile provided by the agency, indicated that patient had an order for Humulin 70/30 (used to treat people with diabetes for the control of high blood sugar) subcutaneous (insertion of medications beneath the skin either by injection or infusion), 100 unit/ml (milliliter – unit of measurement) in the morning, afternoon and evening. During the home visit, the Humulin 70/30 medication was observed being stored inside a bag with Patient 1’s insulin syringes at room temperature. The Humulin 70/30 vial was observed open without label of when it was opened, and manufacturer label indicated to refrigerate the medication. During an interview with Patient 1 on 02/01/2023, at 11:35 a.m., he stated that he takes the insulin medication twice a day instead of three times a day and that he has being doing that for a while. Patient 1 stated that he keeps the insulin medication refrigerated when it is not opened, but once he opens the medication, he keeps it at room temperature with his insulin syringe. Patient 1 further stated that he was not told about labeling the medication after opening and that he was unaware that you needed to keep the medication in the fridge even after opening. During an interview with the Director of Patient Care Services Designee (DPCSD) on 02/02/2023 at 12:04 p.m., he stated that the registered nurses and skilled nurses should be educating the patients on their medications.

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, and measurable indicators to evaluate changes in policy, procedure, and intervention. This failure had the likelihood to result in the HHA to not be able to assess and evaluate negative patient care outcomes, and infection control program surveillance, including the HHA's operations. During a record review of the Quality Assessment and Performance Improvement (QAPI) program on 1/31/23, at 2:20 p.m., the QAPI indicated there was no QAPI program for the 4th quarter. During the interview on 2/2/23, at 11:20 a.m., with the QAPI coordinator, the QAPI coordinator stated he has all of the data for his surveillance. When asked to provide this data, QAPI coordinator provided a box load of paper that he claimed was data he accumulated for the past year for QAPI. A review of the HHA's undated policy titled "Quality Assessment/Performance Improvement" indicated to show measurable improvement in indicators for which there is evidence for improvement of health outcomes. Examples include reduction of hospitalizations, readmissions, emergent care, improved safety, and/or increased quality of care for patients. Measure, analyze, and track quality indicators including adverse patient events and other performance indicators. Assess agency's processes, services and operations.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure that Skilled Nurse (SN) performed standard precautions, to prevent the transmission of infections and communicable diseases for two of seven sampled patients (Patient 1 and Patient 3). The deficient practice had the potential to place patients at risk for transmission of infectious agents 2. A review of Patient 3's clinical record disclosed a start of care dated 8/23/22, with diagnoses which included gangrene (the death of tissue often occurs in the extremities or skin from loss of blood supply. The condition often affects toes, fingers, and limbs, but can affect muscles and organs. Symptoms include discolored skin, severe pain followed by numbness, and foul discharge. Gangrene requires urgent care. Treatment includes antibiotics and removing dead tissue) and Type 2 diabetes mellitus (high blood sugar for prolonged period). A review of Patient 3's plan of care (POC) for the certification period of 12/21/22 through 2/18/23, included orders for the skilled nurse (SN) to visit every other day for 23 days till 1/13/23 and 2 times a week staring 1/15/23 for five weeks plus 3 PRN("pro re nata" or as needed)for wound complications. SN to continue to perform skilled evaluation, observation, assessment of patient other complications of procedures, gangrene, for change and removal of surgical wound dressing, chronic post procedural pain, peripheral vascular disease, type 2 diabetes with diabetic neuropathy, status post right transmetatarsal amputation for signs and symptoms of infection, healing status, response to prescribed wound care treatment, essential hypertension, hyperlipidemia, insomnia, kidney transplant, compliance with medication and diet regimen, infection control measures, knowledge/observance of home safety, response to treatment/medications, disease complications/exacerbations, drug adverse reactions, ineffective drug regimen. SN to continue to instruct patient/caregiver per knowledge deficit identified on the disease processes, signs and symptoms, management, prevention, risk factors, complications, medications dose therapeutic actions, adverse effects, precautions for high risk medications, infection control measures/management, other significant change in condition. Wound management to be performed by SN during scheduled visits and caregiver on the days with no SN visits as follows: Cleanse right metatarsal amputation surgical site with normal saline or wound wash , pat dry and apply Iodoflex (is used for the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetic ulcers, particularly when infection is present or suspected to open wound areas), painted eschar (is a collection of dry, dead tissue within a wound) with betadine, cover with dry gauze, wrapped with kerlix and secured with tape. On 2/1/23 at 12:00 p.m., during a joint home visit with Licensed Vocational Nurse 2 (LVN 2), Patient was observed lying in a bed, with Family Member 1 next to the patient. LVN 2 proceeded with his visit. During observation of LVN 2, LVN 2 did not remove his soiled gloves when reaching inside the gauze package on top of the patients cabinet outside his clean area. LVN 2 did not change his gloves after he performed applying the dressing on Patient 3's right foot. He used the same gloves removing the soiled dressing on the left foot. On concurrent interview with LVN 2, LVN 2 stated that the supplies on top of the patients cabinet is considered dirty. LVN 2 further stated "I should have removed my gloves when reaching for new supplies to prevent contamination." LVN 2 also stated that he disinfects his used equipment and place his equipment back in the slots inside his bag. LVN 2 stated that he disinfects his bag once a week. LVN 2 confirmed that he does not have the a dirty bag and clean bag to separate his medical equipment. During an interview with the Director of Patient Care Services Designee (DPCS Designee), stated that the nurse should have performed proper bag technique during his visit. DPCS also stated the importance of changing gloves and performing proper hand hygiene in between wound dressing changes to prevent infection. A review of the HHA's policy titled "Bag Technique" revised November 2021, indicated as part of the infection/exposure control plan, Care Unlimited health services personnel will consistently implement principles to maximize efficient use of the patient's care supply bag when used for caring patients. Hand washing equipment-alcohol based hand rub (ABHR) and skin cleanser, soap and paper towels. Prior to administering care, ABHR or soap and paper towels will be removed and hands will be washed. The bag will contain a designated clean and dirty area. The clean area contains unused or cleaned supplies/equipment, and the dirty area is designated for contaminated materials. A review of the HHA's policy titled " Infection Control Plan" revised November 2021, indicated the goal is to establish the mechanism by which the organization will address surveillance, prevention, identification, control and reporting of infections, utilizing current scientific methods and epidemiologic principles. Comply with all applicable local, state, and federal regulations, including , but not limited to: State and federal OSHA (Occupational Safety and Health Administration) mandates, CDC (Centers for Disease Control and Prevention) recommendations and guidelines and local regulations including reporting of outbreaks or undue prevalence of infections, parasitic disease or infestation. Care Unlimited Health Services is committed to reducing the risk of acquisition and transmission of healthcare associated infections (HAIs). A review of the HHA's policy titled Section G: Wound Care: Pressure Ulcer Dressing Change" clinical manual, indicated to decrease infection in wounds, Wash hands. Put on gloves and remove old dressing and discard. Apply new pair of gloves. Findings: a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 12/31/2022, with diagnosis of type 2 diabetes mellitus (DM) (impairment in the way the body controls and uses sugar) with foot ulcer (open sores or lesions that will not heal or that return over a long period of time). A review of Patient 1's Plan of Care (POC) for the certification period of 12/31/2022 to 02/28/2023, indicated that a skilled nurse (SN) was scheduled to visit the patient three times a week for eight weeks. The POC further indicated Physical Therapy (PT) evaluation for the week of 01/01/20203. On 02/01/2023, at 11:00 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. During the home visit Patient 1 was observed sitting on a chair by dining room table. LVN 1 was observed taking Patient 1’s blood pressure and temperature using equipment that she took out of her bag and once she completed taking the patient’s vital signs she proceeded to place her equipment back into her bag without. LVN 1 was observed not cleaning her equipment before or after she took Patient 1’s vital signs. During an interview with Licensed Vocational Nurse 1 (LVN 1) on 02/01/2023, at 11:55 a.m., she stated that she cleans her equipment at the end of the day when she gets home. During an interview with the Director of Patient Care Services Designee (DPCSD) on 02/02/2023 at 12:04 p.m., he stated that equipment should be cleaned after patient care. A review of the agency’s policy and procedure titled “Bag Technique,” dated 11/2021, indicated that the purpose of the policy and procedure is to describe the procedure for maintaining a clean nursing bag/computer bag and preventing cross-contamination. The policy and procedure further indicated that when the visit is completed, reusable equipment will be cleaned using alcohol, soap and water or other appropriate solution, hands will be washed and equipment and supplies will be returned to the bag.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure a certified home health aide (CHHA1 )was qualified to provide care prior to providing patient care. The deficient practice had the potential to result in harm and injury to patients. A review of CHHA 1’s employee record indicated there was no verification of license or certificate on file. During an interview with the Business Office Manager (BOM) on 2/2/2023 at 2:26 p.m., the BOM stated she is also the agency’s human resource (HR). BOM stated CHHA 1 completed an application on 7/1/2021 and during that time she was out on leave so everybody at the agency was helping. BOM stated she is not sure who handled the hiring of CHHA 1. BOM stated CHHA 1 worked for the agency from 7/2021 to 1/2022 or 2/2022, but she could not recall the exact date. BOM stated when she returned from leave at the end of 12/2021, she tried to verify CHHA 1’s license online and CHHA 1’s name was not found. BOM stated she then contacted CHHA 1 regarding his license and CHHA 1 informed her that he let his license lapse. BOM stated she informed CHHA 1 he could not work at the agency until an updated license was provided. BOM stated CHHA 1 never provided an updated license, so CHHA 1 has not worked for the agency since. BOM stated prior to working with a patient the license is verified online. BOM further stated CHHA 1’s employee record was incomplete and did not have a license verification on file. A review of the agency’s “Job Title/Position: Certified Home Health Aide,” dated 11/2021, indicated the position's qualifications include: Meets the training requirements and successfully completed: A training and competency evaluation program that meets the needs §484.80 (b) and (C); or A competency evaluation that meets the requirements of §484.80 (c); or A nurse aide training and competency evaluation approved by the state as meeting the requirements of §483.154 and is currently in good standing on the state nurse aide registry; or The requirement of a state licensure program that meets the provision of §484.80 (b) and (c). Shows proof of registration on the Home Care Aide registry through the Department of Social Services, Home Care Bureau, preferred. A review of the agency’s policy and procedure titled “Personnel Record Contents,” dated 11/2021, indicated the content of the personnel files for regular full or part-time personnel or volunteers will include verified professional licensure or certification.