Every finding on record at Isocare Med Extenders 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 # 36459, Health Facilities Evaluator Nurse Surveyor # 44749, Health Facilities Evaluator Nurse Unduplicated admissions - 3 Active Patients - 38 Sample Size - 7 The following Conditions of Participation not met: 484.70 Infection Prevention and Control 484.75 Skilled Professional Services Home Visits - 3

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 all the medications the patient is currently using for one of seven sampled patients (Patients 1). The deficient practice had the potential to result in placing the patients at risk for drug interactions, adverse actions, and medication errors that could affect the patient's already compromised health status. Findings A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/11/2013, with diagnoses which included malignant neoplasm of the brain stem, tracheostomy (an opening created in the front of the neck so a tube can be inserted into the windpipe to help a person breathe) status, gastrostomy (gtube - tube inserted through the belly that brings nutrition directly to the stomach) status, and ventilator dependent (machine needed due to being unable to breathe effectively). A review of Patient 1's Plan of Care (POC) for the certification period of 05/28/2022 to 07/26/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated that LVN to notify physician and agency for any unwanted side effects or adverse reactions after medications are given, assess vital signs every shift, respiratory assessment, gastrointestinal assessment, and assess for safety every shift. On 07/01/2022, at 10:30 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 Miralax ( used to treat occasional constipation), give ½ packet (8.5 milligram) (mg – unit of measurement) via percutaneous endoscopic gastrostomy (PEG - procedure to place a feeding tube through the skin and the stomach wall and goes directly into the stomach) mixed in 4 ounces (oz – unit of measurement) water two times a day as needed for constipation, Ibuprofen (used to reduce fever and to relieve minor aches and pain) 100 mg/5 ml ((milliliter – unit of measurement), give 5ml via PEG every six hours as needed for pain or temperature 100.0 or higher, oxygen therapy administer one liter per minute via tracheostomy every night and as needed, Albuterol (used to prevent and treat wheezing and shortness of breath caused by breathing problems) 0.083 percent (2.5 mg/3 ml), give one respiration via nebulizer every four hours as needed for coughing and wheezing, Famotidine (used to treat and prevent ulcers in the stomach and intestines) 40 mg/5 ml suspension, 50 ml meglupin , take 5 ml, and Poly Vitamin (multivitamin product used to treat or prevent vitamin deficiency) drops, give 5 ml via PEG four times a day. A review of Patient 1’s Polyeth Glycol 3350 NF Powder 510 gm (gram – unit of measurement) prescription label on the bottle indicates to mix half of the cap (8.5 gm in liquid and give via gtube two times a day for 30 days, a review of patient’s Ibuprofen 100 mg/ 5 ml prescription label on the box indicates to take 18 ml (360 mg) via gtube every six hours as needed for mild pain and a review of patient’s Albuterol 0.083 percent (2.5 mg/3 ml) prescription label on the box indicates to use 3 ml via nebulizer three times daily and may give every four hours as needed for wheezing, coughing, respiratory illness. Further review of Patient 1’s medications indicated that patient had Fluocinolone Acetonide Topical Oil (used to relieve redness, itching, swelling, or other discomfort caused by skin conditions) 0.01 percent (Scalp Oil), apply one application topically to scalp twice daily as needed as directed. During an interview with Patient’s Family Member (FM) on 07/01/2022, at 11:35 a.m., she stated that Patient 1 no longer uses oxygen, and that patient no longer takes Famotidine. Patient 1’s FM further that they ran out of Poly Vitamin Drops and the last dose was four days ago. Patient 1’s FM further stated that patient started using the scalp oil in March 2022. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 1:05 p.m., she stated that medication reconciliation should be checked when there is new medication or discharged medication and at the end of a certification period. A review of the agency’s policy and procedure titled, “Medication Reconciliation,” dated 02/2021, indicated that the agency will reconcile patient’s medications at time of admission and on an ongoing basis in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate therapy and non-compliance with drug therapy. The policy and procedure further indicated that medication list/profile will be updated with each new or changed medication.

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 observation, interview and record review, the home health agency (HHA) failed to follow the plan of care (POC) for two of seven sampled patients (Patient 1 and 3). These deficient practices resulted in the patients not receiving the quality of care and services identified in the POC. Findings: a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/11/2013, with diagnoses which included malignant neoplasm of the brain stem, tracheostomy (an opening created in the front of the neck so a tube can be inserted into the windpipe to help a person breathe) status, gastrostomy (gtube - tube inserted through the belly that brings nutrition directly to the stomach) status, and ventilator dependent (machine needed due to being unable to breathe effectively). A review of Patient 1's Plan of Care (POC) for the certification period of 05/28/2022 to 07/26/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated for nutrition to give 125 ml (milliliter – unit of measurement) one can formula per day with 90 ml of water. Additionally, the POC indicated that the LVN to clean the gtube and trach site every shift and as needed and to check residual (volume of fluid remaining in the stomach) before each feeding and medication administration. The POC did not indicate to flush water before and after medication administration. On 07/01/2022, at 10:30 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. During an interview with LVN 1, she stated that she does not clean the gtube or trach site every shift. LVN further stated that she checks residual before feedings but did not state that she checks before medication administration. LVN 1 stated that Patient 1 takes Peptamen 1.5 (nutritionally complete tube feeding formula) twice a day and that she gives 250 ml each feeding and that she flushes 90 ml of water before and after each feeding. Additionally, LVN 1 stated that she flushes 30 ml of water before and after medication administration. LVN 1 unable to answer when the last time she read the POC and stated that she does not read the plan of care too often. A review of Patient 1’s Clinical Notes for the certification period of 05/28/2022 to 07/26/2022, indicated that from 05/28/2022 to 06/25/2022 residual was checked only once a shift. The Clinical Notes further indicated that patient is receiving 500 ml of tube feeding and 360 ml water. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 1:05 p.m., she stated that LVN should be reading the plan of care every recertification and as needed. DPCSD stated that residual is checked before feedings and before medication administration to avoid aspiration. DPCSD further stated according to the POC Patient 1 should only be receiving one can of 125 ml formula with 90 ml of water via gtube and unable to find physician order for the extra formula and water that LVN 1 is giving. b. A review of Patient 3's clinical record indicated a start of care date (SOC) of 10/01/2021, with diagnoses which included cerebral palsy and intestinal malabsorption. A review of Patient 3's Plan of Care (POC) for the certification period of 11/30/2021 to 01/28/2022, included an order for a Certified Home Health Aide CHHA) for 180 to 360 hours every 30 days and Registered Nurse (RN) two hours every visit one time a month. The POC further indicated that the Certified Home Health Aide (CHHA) to monitor infection in the central line, obtain labs and administer medications as ordered. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 1:51 p.m., she stated the POC should be individualized to the patient’s needs but Patient 3’s was not individualized because there where duties that a CHHA is not supposed to do. The DPCSD further stated that CHHA duties include activities of daily living (ADL)and vital signs (VS) and that they should not be administering medications or obtaining labs A review of the agency’s policy and procedure titled, “Plan of Care – CMS #485 and Physician/Practitioner Orders,” dated 02/2022, indicated that skilled nursing and other home health services will be in accordance with the Plan Of Care based on the patient’s diagnosis and assessment of immediate and long-range needs and resources. The policy and procedure further stated that each patient must receive an individualized written plan of care, including any revisions or additions. Additionally, the policy and procedure stated that services must be furnished in accordance with accepted standards of practice and that care and services provided will be provided according to physician/practitioner orders and drug, services and treatments are administered by staff only as ordered by physician/practitioner

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to include acceptable vital sign parameters for three of seven sampled patients (Patient 1, 2, and 3). The deficient practice had the potential for staff to be unaware of what to report to the physician if there is a change in condition. Findings: a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/11/2013, with diagnoses which included malignant neoplasm of the brain stem, tracheostomy (an opening created in the front of the neck so a tube can be inserted into the windpipe to help a person breathe) status, gastrostomy (gtube - tube inserted through the belly that brings nutrition directly to the stomach) status, and ventilator dependent (machine needed due to being unable to breathe effectively). A review of Patient 1's Plan of Care (POC) for the certification period of 05/28/2022 to 07/26/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated that LVN to notify physician and agency for any unwanted side effects or adverse reactions after medications are given, assess vital signs every shift, respiratory assessment, gastrointestinal assessment, and assess for safety every shift. Additionally, the POC indicated that the LVN to notify the physician and the agency of any significant findings, but the POC did not indicate what parameters or significant findings to report. b. A review of Patient 2's clinical record indicated a start of care date (SOC) of 07/23/2008, with diagnoses which included acute and chronic respiratory failure, craniosynostosis and ventilator dependent. A review of Patient 2's Plan of Care (POC) for the certification period of 05/11/2022 to 07/09/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated that LVN to notify physician and agency for any unwanted side effects or adverse reactions after medications are given, assess vital signs every shift, respiratory assessment, gastrointestinal assessment, and assess for safety every shift. Additionally, the POC indicated that the LVN to notify the physician and the agency of any significant findings, but the POC did not indicate what parameters or significant findings to report. c. A review of Patient 3's clinical record indicated a start of care date (SOC) of 10/01/2021, with diagnoses which included cerebral palsy and intestinal malabsorption. A review of Patient 3's Plan of Care (POC) for the certification period of 11/30/2021 to 01/28/2022, included an order for a Certified Home Health Aide CHHA) for 180 to 360 hours every 30 days and Registered Nurse (RN) two hours every visit one time a month. The POC further indicated that CHHA to assess vital signs every shift. Additionally, the POC indicated that the CHHA to notify the physician and the agency of any significant findings, but the POC did not indicate what parameters or significant findings to report. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 1:05 p.m. and 1:51 p.m., she stated that Patient 1, Patient 2, and Patient 3 did not have parameters in their plan of care and that there should be parameters so that staff know when to notify MD if there is a change in condition. A review of the agency’s policy and procedure titled “Care Planning Process,” dated 02/2021, indicated that in order to assure that care provided is appropriately planned to meet each patient’s specific needs and problems, the agency will utilize data/information gathered during patient assessment in the care planning process.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to have performance improvement projects (PIP) conducted every year. This failure had the potential to affect the quality of care provided to the patients. Based on interview and record review, the home health agency (HHA) failed to have performance improvement projects (PIP) conducted every year. This failure had the potential to affect the quality of care provided to the patients. Findings: Documentation of performance improvement projects on record review was not on-going and data driven. The agency could not provide sufficient evidence to track, analyze, and implement a (PIP). During an interview, on 7/5/2022 at 6:30 p.m., the Administrator (ADM) stated they look at current issues and try to address identified problem for topics of their (PIP). The ADM stated we try and choose our QAPI projects to be preemptive and not wait until it’s a problem. ADM is aware of the QAPI requirements, but could not provide any evidence of past projects and stated, what you got, is what we have. The HHA"S policy and procedure titled, "Quality Assurance and Performance Improvement Plan and Program," revised 2/2022, indicated the agency will establish an on-going, data -driven program of quality assurance and performance improvement. Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure that the Condition of Participation for Infection Prevention and Control was met as follows: 1. The home health agency failed to ensure a process of documenting an employee’s approval for medical or religious exemption for five of 58 agency employees (Licensed Vocational Nurse [LVN 3, LVN 6, LVN 13], Quality Assurance [QA] and Certified Home Health Aide [CHHA 1]). (Refer to G687) 2. The home health agency failed to implement the agency’s policy and procedure regarding COVID-19 (coronavirus - a severe respiratory illness caused by virus and spread from person to person) testing for four of five unvaccinated employees (LVN 3, LVN 13, QA and CHHA 1). (Refer to G687) The cumulative effect of these systemic problems resulted in the HHA's inability to ensure the provision of quality health care in a safe environment, had the potential to result in placing patients and employees at risk for spreading and/or contracting COVID-19 infection, that could lead to severe respiratory illness, hospitalization and/or death.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to: 1. Ensure a process of documenting an employee’s approval for medical or religious exemption for five of 58 agency employees (Licensed Vocational Nurse [LVN 3, LVN 6, LVN 13], Quality Assurance [QA] and Certified Home Health Aide [CHHA 1]). 2. Implement the agency’s policy and procedure regarding COVID-19 (coronavirus - a severe respiratory illness caused by virus and spread from person to person) testing for four of five unvaccinated employees (LVN 3, LVN 13, QA and CHHA 1). Findings: On 06/30/2022 and 07/05/2022, a review of the agency’s COVID-19 policy and procedure and COVID-19 employee vaccination log was conducted. The COVID-19 vaccination log indicated that there were five (LVN 3, LVN 6, LVN 13, QA and CHHA 1) out of 58 employees who did not receive the COVID-19 vaccine and that they each submitted a letter regarding reason why they were not taking the vaccine. During an interview with the Director of Patient Care Services (DPCS) on 07/05/2022 at 3:36 p.m. and 6:30 p.m., he stated that the agency was approving religious exemptions and that he verbally approved the employees who submitted a letter requesting a religious exemption. The DPCS stated he did not do any paperwork or documentation regarding the approval of the religious exemption. The DPCS further stated that unvaccinated employees have to get PCR (polymerase chain reaction – test detects the presence of a virus if you have the virus at the time of testing) tested weekly. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 6:58 p.m., she stated that LVN 6 is the only unvaccinated employee the agency has copies of his weekly COVID-19 testing. The DPCSD stated that the agency does not have copies of the weekly COVID-19 testing for the other unvaccinated employees and that they call medical records department and notify verbally of the results of their weekly testing, and there is no verification or submission of test results is conducted. A review of the agency’s policy and procedure titled, “COVID-19 Vaccine Mandate Policy,” dated 02/2022, indicated that the agency has developed and implemented policies and procedures to ensure that all staff are fully vaccinated for COVID-19. The policy and procedure further stated that employees who are not fully vaccinated will comply with the policy for testing. The policy and procedure further indicated that employees who report to the workplace at least once every seven days must be tested for COVID-19 at least once every seven days and must provide documentation of the most recent COVID-19 test results to the agency. Additionally, the policy and procedure indicated that request for non-medical exemption must be approved by the agency Administrator and documented in employee health.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure that the Condition of Participation for Skilled Professional Services was met as follows: 1. The home health agency failed to ensure that Licensed Vocational Nurse (LVN 1), had an updated training for the management of patients on tracheostomy (a surgical opening created through the neck into the trachea (windpipe) to allow direct access to the breathing tube) with ventilator (a breathing machines that help pump oxygen into the lungs) machine, for one of seven sampled patients (Patient 1). For Patient 1, who was on ventilator machine, LVN 1 did not know the patient's ventilator machine settings. (Refer to G702) 2. The home health agency failed to provide service that was ordered by the physician, as indicated in the plan of care, for three of seven sampled patients (Patient 1, 2, and 3). The Licensed Vocational Nurse 1 (LVN 1), did not take Patient 1's vital signs (clinical measurements, pulse rate, temperature, respiration rate, and blood pressure, that indicate the state of patient's essential body functions) during the home visit. For Patient 2, the HHA did not had a record of the patients' blood pressure for the recertification period of 5/12/2022 to 6/25/2022, and for Patient 3, the HHA did not document accurate blood pressure for recertification period of 11/30/2021 to 12/29/2021. (Refer to G710) The cumulative effect of these systemic practices resulted in the agencies failure to ensure the care and services were provided as indicated on the patient's plan of care (POC) to reach patient's care goals. Findings:

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the home health agency failed to ensure that Licensed Vocational Nurse 1 (LVN 1), had an updated training for the management of patients on tracheostomy (a surgical opening created through the neck into the trachea (windpipe) to allow direct access to the breathing tube) with ventilator (a breathing machines that help pump oxygen into the lungs) machine, for one of seven sampled patients (Patient 1). For Patient 1, who was on ventilator machine, LVN 1 did not know the patient's ventilator machine setting. This deficient practice placed the patient at risk for respiratory distress or death due to the licensed nurse’s lack of knowledge regarding management of patient with a ventilator machine. Findings A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/11/2013, with diagnoses which included malignant neoplasm of the brain stem, tracheostomy (an opening created in the front of the neck so a tube can be inserted into the windpipe to help a person breathe) status, gastrostomy (gtube - tube inserted through the belly that brings nutrition directly to the stomach) status, and ventilator dependent (machine needed due to being unable to breathe effectively). A review of Patient 1's Plan of Care (POC) for the certification period of 05/28/2022 to 07/26/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated that LVN to notify physician and agency for any unwanted side effects or adverse reactions after medications are given, assess vital signs every shift, respiratory assessment, gastrointestinal assessment, and assess for safety every shift. On 07/01/2022, at 10:30 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. During the home visit, a review of Patient 1’s POC provided by the agency, indicated that the patient’s ventilator model/type was HT70 Plus with settings that included A/C (assist/control) mode, rate 16 BPM (breath per minute), IPAP (inspiratory positive airway pressure) 24 cm (centimeters-unit of measurement) H2O (water), 6 cm H20, ITime (inspiratory time) 1.2 seconds up to 1 LMP (liter per minute) supplemental oxygen through the ventilator. During an interview with LVN 1 to verify the ventilator settings that was listed on the POC and on the Weekly Ventilator Flow Sheet, LVN was unable to verify the settings. LVN 3 was observed staring at the ventilator for five minutes trying to figure out the model and settings listed on the POC and on the Weekly Ventilator Flow Sheet. LVN 3 was asked about the alarm levels on the ventilator, and she was unable to verify the settings. Patient 1’s Family Member was the one who was able to show the screen to verify the alarm settings. LVN 1 stated that the last time she was trained on the ventilator was 3-4 years ago, but no certificate was provided. Observed the Alarm Settings in the ventilator screen indicated High Pressure Alarm was set at 35 and the Low Pressure Alarm was 14. A review of Patient 1’s Weekly Ventilator Flow Sheet from 06/19/2022 to 06/25/2022 provided by the agency indicated that the High Pressure Alarm was 37 and the Low Pressure Alarm was 14. A review Patient 1’s home folder indicated that the most recent Weekly Ventilator Flow Sheet was not in the folder. LVN 1 stated that she left the paperwork at home. A review of LVN 1’s employee record, indicated that she had a Ventilator Proficiency test but did not indicate when the test was taken. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 1:05 p.m., she stated that all paperwork and charting of the patient needs to be kept in the patient’s home folder and not taken home. DPCSD stated that LVN is supposed to be familiar with the ventilator settings and when they fill out the Ventilator Flow Sheet, they should look at the ventilator machine and the plan of care. DPCSD further stated that LVN 1 had a Ventilator Proficiency test done upon hire on 09/16/2016 and no other recent ventilator training found on the employee record. A review of the agency’s policy and procedure titled “Inservice Education,” dated 02/2021, indicated that regularly scheduled and appropriate inservice programs will be made available for all employees. The policy and procedure further indicated that the purpose of the policy and procedure was to ensure the continuing education of all agency personnel. Additionally, the policy and procedure indicated that direct care personnel must have a minimum of 12 hours of ongoing education during 12-month period.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency failed to provide service as ordered by the physician and as indicated in the patient plan of care (POC), for three of seven sampled patients (Patient 1, 2, and 3). The HHA failed for the Licensed Vocational Nurse 1 (LVN 1), to take Patient 1's vital signs during the home visit. For Patient 2 and 3, the HHA did not had a record of the patients' blood pressure in the patient's medical record. The deficient practice had the potential to affect the patient’s progress to meet the patient care goals. a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 09/11/2013, with diagnoses which included malignant neoplasm of the brain stem, tracheostomy (an opening created in the front of the neck so a tube can be inserted into the windpipe to help a person breathe) status, gastrostomy (gtube, a soft plastic tube inserted through the belly that brings nutrition directly to the stomach) status, and ventilator dependent (machine needed due to being unable to breathe effectively). A review of Patient 1's Plan of Care (POC) for the certification period of 05/28/2022 to 07/26/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated that LVN to notify physician and agency for any unwanted side effects or adverse reactions after medications are given, assess vital signs every shift, respiratory assessment, gastrointestinal assessment, and assess for safety every shift. On 07/01/2022, at 10:30 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 1) was conducted at Patient 1’s residence. During an interview with LVN 1, she stated that she is unable to do the vital signs because she left her equipment at home. A review of Patient 1’s Clinical Notes for the certification period of 05/28/2022 to 07/26/2022, indicated that from 05/28/2022 to 06/25/2022 there was no blood pressure documented. b. A review of Patient 2's clinical record indicated a start of care date (SOC) of 07/23/2008, with diagnoses which included acute and chronic respiratory failure, craniosynostosis and ventilator dependent. A review of Patient 2's Plan of Care (POC) for the certification period of 05/11/2022 to 07/09/2022, included an order for a Licensed Vocational Nurse (LVN) for 480 hours every 30 days and Registered Nurse (RN) two hours every visit twice a month. The POC further indicated that LVN to notify physician and agency for any unwanted side effects or adverse reactions after medications are given, assess vital signs every shift, respiratory assessment, gastrointestinal assessment, and assess for safety every shift. A review of Patient 2’s Clinical Notes for the certification period of 05/11/2022 to 07/09/2022, indicated that from 05/12/2022 to 06/25/2022 during the 12:00 a.m. to 8:00 a.m. shift there was no blood pressure documented. c. A review of Patient 3's clinical record indicated a start of care date (SOC) of 10/01/2021, with diagnoses which included cerebral palsy and intestinal malabsorption. A review of Patient 3's Plan of Care (POC) for the certification period of 11/30/2021 to 01/28/2022, included an order for a Certified Home Health Aide CHHA) for 180 to 360 hours every 30 days and Registered Nurse (RN) two hours every visit one time a month. The POC further indicated that CHHA to assess vital signs every shift. A review of Patient 3’s Clinical Notes for the certification period of 11/30/2021 to 01/28/2022, indicated that from 11/30/2021 to 12/19/2021 the blood pressure was not documented correctly. The Clinical Notes indicated that on the section that the blood pressure was documented, there was only one number instead of two numbers. During an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 1:05 p.m. and 1:51 p.m., she stated vital signs should be checked every shift and it include blood pressure, respiration, heart rate and temperature. The DPCSD further stated that when documenting the blood pressure, it should have two numbers which are the systolic and diastolic. A review of the agency’s policy and procedure titled “Plan of Care – CMS #485 and Physician/Practitioner Orders,” dated 02/2022, indicated that skilled nursing and other home health services will be in accordance with the Plan Of Care based on the patient’s diagnosis and assessment of immediate and long-range needs and resources. The policy and procedure further stated that each patient must receive an individualized written plan of care, including any revisions or additions. Additionally, the policy and procedure stated that services must be furnished in accordance with accepted standards of practice and that care and services provided will be provided according to physician/practitioner orders and drug, services and treatments are administered by staff only as ordered by physician/practitioner.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure that at least 12 hours of in-service during a 12-month period was provided to the Certified Home Health Aides employed at the agency. This deficient practice has the potential risk for the CHHA not to have updated knowledge and skills to provide the highest quality of patient care services. Findings On 07/05/2022, a review of the agency’s CHHA in-services was conducted. The CHHA In-service for 2021 indicated that there were three in-services conducted for 2021. The CHHA in-services was conducted on 10/01/2021, 11/05/2021 and 12/03/2021 but has no time and the instructor name indicated. During an interview with the Director of Patient Care Services (DPCS) on 07/05/2022 at 6:30 p.m., he stated that the agency has always had at least one CHHA on employed or on call if needed. A review of the agency’s policy and procedure titled “In-service Education,” dated 02/2021, indicated that home health aides are required to receive at least 12 hours of in-service training during each 12-month period. The policy and procedure further indicated that the agency maintains documentation that demonstrates that each HHA has met the requirements.

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 have qualified personnel, 16 of 58 licensed staff failed to; 1. Ensure three of 58 staff Licensed Vocational Nurse (LVN 1, LVN 3, LVN 4, LVN 7 and LVN 12) had updated History and Physical examinations. 2. Ensure 15 of 58 staff Registered Nurse (RN1, RN 2) and Licensed Vocational Nurse (LVN 1, LVN 2, LVN 3, LVN 4, LVN 5, LVN 6, LVN 7, LVN 8, LVN 9, LVN 10, LVN 11, LVN 12, LVN 13, LVN 14) had updated ventilator training. 3. Ensure 16 of 58 staff Registered Nurse (RN1, RN 2), Licensed Vocational Nurse (LVN 1, LVN 2, LVN 3, LVN 4, LVN 5, LVN 6, LVN 7, LVN 8, LVN 9, LVN 10, LVN 11, LVN 12, LVN 14) and Certified Home Health Aide (CHHA 2) had a competency review. The deficient practice had the potential risk for these patients not to receive quality of care and services provided by the unqualified personnel. FindingsDuring an interview with the Director of Patient Care Services Designee (DPCSD) on 07/05/2022 at 4:18 p.m., she confirmed the following records were missing from the following employee records: 1. Ensure three of 58 staff Licensed Vocational Nurse (LVN 1, LVN 3, LVN 4, LVN 7 and LVN 12) had updated History and Physical examinations. 2. Ensure 15 of 58 staff Registered Nurse (RN1, RN 2) and Licensed Vocational Nurse (LVN 1, LVN 2, LVN 3, LVN 4, LVN 5, LVN 6, LVN 7, LVN 8, LVN 9, LVN 10, LVN 11, LVN 12, LVN 13, LVN 14) had updated ventilator training. 3. Ensure 16 of 58 staff Registered Nurse (RN1, RN 2), Licensed Vocational Nurse (LVN 1, LVN 2, LVN 3, LVN 4, LVN 5, LVN 6, LVN 7, LVN 8, LVN 9, LVN 10, LVN 11, LVN 12, LVN 14) and Certified Home Health Aide (CHHA 2) had a competency review. A review of facility’s policy titled, “Personnel Records” dated 02/2022 indicated the personnel record for an employee will include: observed competencies- initial and ongoing and home health aide competency: initial and annually. The policy and procedure further indicated that the health record for applicable employees will include: PPD test or chest x-ray results and any other agency required health requirements.