Every finding on record at Friends Home Health Care Inc

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Survey Dates: 1/31/2022 - 2/4/2022, 2/7/2022 At this Emergency Preparedness survey, Friends Home Health Care Inc., was found not to be in compliance with Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers, 42 CFR 484.102.

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 record review and interview, the agency failed to implement and maintain an emergency preparedness plan and failed to follow all local and state emergency preparedness regulations for 1 of 1 agency's emergency preparedness plans reviewed. Findings include: A document titled “State of Indiana Executive” indicated but was not limited to; “For Further Continuation of Limited Provisions to Address the Impact and Spread of the Coronavirus Disease (COVID-19) … Individuals who are symptomatic and test negative should isolate until their symptoms have resolved … Fully Vaccinated individuals who are close contacts of a person who tests positive for COVID-19 may continue their normal activities but must wear a mask at all time in public for 10 days and are encouraged to obtain a COVID-19 test 5 days after exposure. Unvaccinated individuals who are close contacts of a COVID-19 infected person shall quarantine … signed by Eric J. Holcomb under the authority vested as Governor by the Indiana Constitution and the laws of the state of Indiana. A binder titled “Emergency Preparedness Planning and Resource Manual” was provided by the administrator on 02/02/2022 at 9:30 a.m. The binder included the following: A document titled “Key Contacts Information” failed to evidence a contact number for the electric company, the gas company, and the medical supply company. A document titled “Succession of Command” indicated but was not limited to; “Friends Home Health Care (agency name) has developed the following list of specific key personnel based on job the title to clearly identify the order of succession of command. The Succession of Command structure considers the Agency’s ability to manage and direct an emergency situation during normal hours of operation as well as during nights and weekends.” The document failed to evidence the succession of command and all entries for Name, Job Title, and Contact information were left blank. A document titled “Incident Command Post” indicated but was not limited to; The Incident Command Post is a designated area where the Incident Commander, management team, and other staff members convene to review the situation and develop tactics and strategies to manage the incident.” The form was not completed and failed to evidence the incident command post during an emergency or disaster, the alternate Incident Command Post, the remote command post, and the agency staff members and the team that are to convene at the post. A document titled “Incident Commander” indicated but was not limited to; The most qualified staff member on duty at the time of the emergency will assume the Incident Commander position until the Administrator or his/her designees arrives at the agency. The document was incomplete and failed to identify the individuals trained for the role or to assume the role. A document titled “Emergency Procedure- COVID-19 (Coronavirus) Pandemic” indicated but was not limited to; “Early reports suggest transmission most commonly occurs during close exposure to a person infected with COVID-19 … The incubation period (time between exposure and development of symptoms) is estimated to be 4 days (range 2-7 days) … 8. The following measures should be implemented immediately to protect staff and prevent transmission of infection to patients … Screen all employees at the beginning of their shift for fever or respiratory symptoms. Actively take their temperature and document the absence of shortness of breath, new or change in cough, and sore throat … Screen for fever and respiratory symptoms following exposure for 1-3 days … post signs for cough etiquette … appropriate PPE should be used by healthcare personnel when coming in contact with the patient …" During an interview on 01/31/2022 at 1:59 p.m., the administrator stated they follow guidelines set forth by the CDC and no one had time to write policies with every change. During an interview on 02/01/2022 Licensed Practical Nurse (LPN) M stated they do not screen themselves or patients daily for symptoms of COVID-19 and document the absence of symptoms. LPN M stated masks are not required, and they have not been provided a mask by the agency but have ordered their own N95 mask. During an interview on 02/01/2022 at 4:15 p.m. the administrator stated she printed updates for COVID-19 and they were laying around but she hadn’t had time to put them in a binder and patients would not want them wearing masks in the home.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to implement and have established policies and procedures for the Coronavirus (COVID-19) pandemic while the state was under a Public Health Emergency as a result of the COVID-19 virus and had been since March 6th 2020 for 1 of 1 agency reviewed. Findings include: A review of the emergency preparedness binder on 02/02/2022 evidenced a document titled “Emergency Procedure- COVID-19 (Coronavirus) Pandemic” that indicates but is not limited to; “Early reports suggest transmission most commonly occurs during close exposure to a person infected with COVID-19 … The incubation period (time between exposure and development of symptoms) is estimated to be 4 days (range 2-7 days) … 8. The following measures should be implemented immediately to protect staff and prevent transmission of infection to patients … Screen all employees at the beginning of their shift for fever or respiratory symptoms. Actively take their temperature and document the absence of shortness of breath, new or change in cough, and sore throat … Screen for fever and respiratory symptoms following exposure for 1-3 days … post signs for cough etiquette … appropriate PPE should be used by healthcare personnel when coming in contact with the patient …" A review of the agency’s COVID-19 binder on 01/31/2022 evidenced the binder had not been updated since November of 2020 and did not contain the most recent Center for Disease Control (CDC) recommended guidelines. During home visit observations on 01/31/2022 and 02/02/2022, Licensed Practical Nurse (LPN) M, Home Health Aide (HHA) K, and personal care attendant G all failed to screen the patients for signs and symptoms of COVID-19 prior to performing, failed to screen themselves for signs and symptoms of COVID-19 prior to performing care, and failed to wear proper personal protective equipment (PPE) while providing patient care. During an interview on 01/31/2022 at 1:59 p.m., the administrator stated they follow guidelines set forth by the CDC and no one had time to write policies with every change. During an interview on 02/01/2022 at 4:15 p.m. the administrator stated she prints updates for COVID-19 and they are laying around but she hadn’t had time to put them in a binder and patients would not want them wearing masks in the home.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan contained the names and contact information for all staff, patients, physicians, and other entities providing services integrated into the emergency preparedness binder for 1 of 1 agency reviewed. Findings include: A document titled "Agency Communication Plan" as part of the emergency preparedness binder was provided by the administrator on 02/01/2022. The document indicated, but was not limited to; "The communication plan includes the following: Staff, entities providing care under an arrangement, patient's physicians (available in printed form or on a computer system) … it should be readily available and accessible … a method for sharing information …" A document titled “Succession of Command” that indicated but was not limited to; “Friends Home Health Care (agency name) has developed the following list of specific key personnel based on a job title to clearly identify the order of succession of command. The Succession of Command structure considers the Agency’s ability to manage and direct an emergency situation during normal hours of operation as well as during nights and weekends.” The document failed to evidence the succession of command and all entries for Name, Job Title, and Contact information were left blank. A document titled “Incident Command Post” indicated but was not limited to; The Incident Command Post is a designated area where the Incident Commander, management team, and other staff members convene to review the situation and develop tactics and strategies to manage the incident.” The form was not completed and failed to evidence the incident command post during an emergency or disaster, the alternate Incident Command Post, the remote command post, and the agency staff members and the team including their contact information that is to convene at the post. A document titled “Incident Commander” indicated but was not limited to; The most qualified staff member on duty at the time of the emergency will assume the Incident Commander position until the Administrator or his/her designees arrives at the agency. The document was incomplete and failed to identify the individuals trained for the role or to assume the role. A binder titled “Emergency Preparedness Planning and Resource Manual” was provided by the administrator on 02/02/2022 at 9:30 a.m. The binder included the following: A document titled “Key Contacts Information" contained contact information for the administrator, alternate administrator, and RN C. The document contained the name of the gas company, electric company, and medical supply company but failed to include any information on how to contact those entities. The binder failed to evidence contact information for each patient, their physicians, and all staff members of the agency. During an interview on 02/07/2022, the alternate administrator stated the information was not in the emergency preparedness binder because she kept it in a separate binder that she always carried with her or whoever is on call would carry it.

This visit was for a Federal re-certification survey in conjunction with a focused Covid-19 infection control survey of a home health agency. Extended survey was announced on 2/1/2022 at 4:30 p.m. Survey dates: 1/31/2022-2/4/2022, 2/7/2022 An Immediate Jeopardy related to §484.70 Infection Prevention and Control was identified and announced on 2/2/2022 at 9:37 a.m. The immediate jeopardy was unremoved at the survey exit date of 02/07/2022 at 12:50 p.m. Friends Home Health Inc. voluntarily terminated from the CMS Program effective 02/14/2022. Based on the Condition-level deficiencies identified during the 2/2/2022 survey, your home health agency was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act, on 2/2/2022 at 9:37 a.m. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training and/or competency evaluation programs for two years beginning 2/7/2022 and continuing through 2/6/2024.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients were informed of factors that could affect their health during a pandemic for 3 of 8 records reviewed (Patient 1, 2, and 6) Findings include: Based on record review and interview, the agency failed to ensure patients were informed of factors that could affect their health during a pandemic for 8 of 8 records reviewed (Patient 6 ) Findings include: 1. A revised 2014 policy titled Patient Bill of Rights was provided by the Alternate Administrator on 1/31/2022 at 1:30 p.m. The policy indicated, but was not limited to, “Patients have the Right: … To effective communication … 3. Patients will be informed of their rights on an ongoing basis as indicated.’ 2. Home Health Aide (HHA) K tested positive for COVID-19 on 01/26/2022. Record review for patient 6 indicated HHA K provided care unmasked for patient 6 on 01/26/2022, 01/27/2022, 01/28/2022, and 1/31/2022 while knowingly positive for COVID-19. No documentation exists evidencing patient 6 was notified and permission was obtained for HHA K to provide care without proper protective equipment for patient 6. The agency failed to take responsibility for their safety and the health and safety of those around them by taking appropriate preventative measures to prevent the spread of COVID-19. 3. Registered Nurse (RN) C tested positive for COVID-19 on 01/14/2022. Clinical record review for patient 1 and patient 2, who both live together, indicated RN C provided care without a mask for patient 1 on 01/14/2022. The agency failed to indicate if RN C self-screen was done and failed to indicate if patients 1 & 2 were pre-screened prior to the home visit. The agency failed to evidence patient 1, and patient 2 were notified of their exposure to COVID-19. 4. The Administrator tested positive for COVID-19 on 01/24/2022. The Administrator provided care for patient 1 on 01/22/2022 and 01/23/2022. The agency failed to evidence Patient 1 and Patient 2 were notified of their exposure to COVID-19. 5. The agency failed to have policies and procedures that identify who will be responsible for notifying close contacts, local, and/or state health officials. The agency failed to provide an agency policy on tracking and surveillance of COVID-19 cases, quarantine, and isolation periods. 1. A revised 2014 policy titled Patient Bill of Rights was provided by the Alternate Administrator on 1/31/2022 at 1:30 p.m. The policy indicated, but was not limited to, “Patients have the Right: … To effective communication … 3. Patients will be informed of their rights on an ongoing basis as indicated.’ 2. Home Health Aide (HHA) K tested positive for COVID-19 on 01/26/2022. Record review for patient 6 indicated HHA K provided care unmasked for patient 6 on 01/26/2022, 01/27/2022, 01/28/2022, and 1/31/2022 while knowingly positive for COVID-19. No documentation exists evidencing patient 6 was notified and permission was obtained for HHA K to provide care without proper protective equipment for patient 6. The agency failed to take responsibility for their safety and the health and safety of those around them by taking appropriate preventative measures to prevent the spread of COVID-19. 3. Registered Nurse (RN) C tested positive for COVID-19 on 01/14/2022. Clinical record review for patient 1 and patient 2, who both live together, indicated RN C provided care without a mask for patient 1 on 01/14/2022. The agency failed to indicate if RN C self-screen was done and failed to indicate if patients 1 & 2 were pre-screened prior to the home visit. The agency failed to evidence patient 1, and patient 2 were notified of their exposure to COVID-19. 4. The Administrator tested positive for COVID-19 on 01/24/2022. The Administrator provided care for patient 1 on 01/22/2022 and 01/23/2022. The agency failed to evidence Patient 1 and Patient 2 were notified of their exposure to COVID-19. 5. The agency failed to have policies and procedures that identify who will be responsible for notifying close contacts, local, and/or state health officials. The agency failed to provide an agency policy on tracking and surveillance of COVID-19 cases, quarantine, and isolation periods.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all services outlined in the plan of care were received for 1 of 6 active record review. (Patient 6) Findings include: A revised 2014 policy titled Patient Rights was provided by the Alternate Administrator on 1/31/2022 at 1:30 p.m. The policy indicated, but was not limited to, “To be admitted to the Agency only if it has the resources needed to provide the care safely and at the required level of intensity, as determined by a professional assessment …" During a home visit on 1/31/2022 at 3:10 p.m. patient 6’s parent indicated the agency had trouble with staffing once patient 6 was admitted. The parent indicated the agency hired a family member to care for patient 6. The complete clinical record for patient 6 was reviewed on 2/1/2022, start of care (SOC) date 1/23/2021, certification period 11/23/2021 to 1/21/2022, with orders for home health aide up to 10 hours /day 2-5 times a week times 9 weeks to assist with personal care, activities of daily living (ADLs) and light housekeeping as needed. Review of a Communication Note dated 11/23/2021 indicated “Client admitted prior was requested. Will begin care when prior is approved + staff is hired. Mother + Dr aware [alternate administrator]”. Review of a Communication Note dated 12/27/2021 indicated “Client mother + Dr were notified of staff being hired & available to start working 12/28/2021. [alternate administrator]” The agency failed to provide home health aide services between 11/23/2021 to 11/27/2021. During an interview on 2/1/2022 at 4:30 p.m. the Administrator indicated the agency must admit the patient in order to get prior authorization. The Administrator indicated he/she had an aide hired to care for patient 6, but the aide quit. The agency did not have enough staff to cover the 5-week period.

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, record review, and interview, the agency failed to provide care with a reasonable expectation that a patient’s health needs could be meet for 1 of 7 active records reviewed. (Patient 6) (See G0570); failed to ensure the plan of care included the visit frequency and duration of services (See G0574); failed to provide a copy of written instructions to the patient and caregiver (See G0612); failed to provide a written schedule that included visit frequency to potentially affect all active patients (See G0614); failed to ensure patients received written information regarding the patient's medication regimen in plain language which also identified who was responsible for giving each medication potentially affecting all patients (See G0616); and failed to narrow the scope of the quality assessment performance improvement (QAPI) program to concentrate on infection control issues that would lead to an immediate correction of any identified problem that directly or potentially threatened the health and safety of patients (See G0652). The cumulative effect of this systemic problem resulted in the facility being out of compliance with 42 CFR 484.60Condition of Participation: Care Planning, Coordination of Services, and Quality of Care. In regards to G570 findings include: A revised 2014 policy titled Patient Rights was provided by the Alternate Administrator on 1/31/2022 at 1:30 p.m. The policy indicated, but was not limited to, “To be admitted to the Agency only if it has the resources needed to provide the care safely and at the required level of intensity, as determined by a professional assessment …" During a home visit on 1/31/2022 at 3:10 p.m. patient 6’s parent indicated the agency had trouble with staffing once patient 6 was admitted. The parent indicated the agency hired a family member to care for patient 6. The complete clinical record for patient 6 was reviewed on 2/1/2022, start of care (SOC) date 1/23/2021, certification period 11/23/2021 to 1/21/2022, with orders for home health aide up to 10 hours /day 2-5 times a week times 9 weeks to assist with personal care, activities of daily living (ADLs) and light housekeeping as needed. Review of a Communication Note dated 11/23/2021 indicated “Client admitted prior was requested. Will begin care when prior is approved + staff is hired. Mother + Dr aware [alternate administrator]” Review of a Communication Note dated 12/27/2021 indicated “Client mother + Dr were notified of staff being hired & available to start working 12/28/2021. [alternate administrator]” The agency failed to provide home health aide services between 11/23/2021 to 11/27/2021. During an interview on 2/1/2022 at 4:30 p.m. the Administrator indicated the agency must admit the patient in order to get prior authorization. The Administrator indicated he/she had an aide hired to care for patient 6, but the aide quit. The agency did not have enough staff to cover the 5-week period.

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 record review and interview, the agency failed to ensure the plan of care included the visit frequency and duration of services for 4 of 8 clinical records reviewed. (Patients 1, 2, 3, 6) Findings include: The complete clinical record for patient 6 was reviewed on 2/1/2022, start of care (SOC) date 1/23/2021, certification period 11/23/2021 to 1/21/2022, with orders for home health aide up to 10 hours /day 2-5 times a week times 9 weeks to assist with personal care, activities of daily living (ADLs) and light housekeeping as needed. The agency failed to ensure a specific range in frequency was ordered. During an interview on 1/31/2022 at 4:30 p.m. 4:30p.m. the Administrative was unable to provide additional information as to why the frequency was wrote as “up to” which implies “0” as a frequency. Finding include: Findings include: 1. A revised 2015 policy titled Plan of Care – CMS #485 and Physician Orders was provided by the Alternate Administrator on 1/31/2022 at 1:30 p.m. The policy indicated, but was not limited to, “22. Medical orders may authorize a specific range in the frequency of visits for each service (e.g., 2-4 visits per week) to ensure that the most appropriate level of service is provided to the patient. However, ranges that include “0” as a frequency are not allowed, because “0” is not a frequency.” 2. The complete clinical record for patient 6 was reviewed on 2/1/2022, start of care (SOC) date 1/23/2021, certification period 11/23/2021 to 1/21/2022, with orders for home health aide up to 10 hours /day 2-5 times a week times 9 weeks to assist with personal care, activities of daily living (ADLs) and light housekeeping as needed. The agency failed to ensure a specific range in frequency was ordered. 3. During an interview on 1/31/2022 at 4:30 p.m. 4:30p.m. the Administrative was unable to provide additional information as to why the frequency was wrote as “up to” which implies “0” as a frequency. 4. The complete clinical record for patient 1, start of care (SOC) 06/09/2020, for the certification period 12/01/2021-01/29/2022 was reviewed on 01/31/2022 and evidenced the following: A document titled "Home Health Certification and Plan of Treatment" for the certification period 12/01/2021 through 01/29/2022 with orders for "HHA [home health aide] up to 6 hours [per] day 1-3 visits/day x [times] 7 days x 9 weeks to assist with personal care, ADLs [activities of daily living] light housekeeping as needed." 5. The complete clinical record for patient 2, SOC 11/03/2014, for the certification period 11/25/2021-01/23/2022 was reviewed on 01/31/2022 and evidenced the following: A document titled "Home Health Certification and Plan of Treatment" for the certification period 11/25/2021-01/23/2022 with orders for "HHA up to 10 hours [per] day x 7 days a week 3-5 visits per day to assist with personal care, feeding … " 6. The complete clinical record for patient 3, SOC 12/17/2020, for the certification period 12/12/2021-02/09/2022 was reviewed on 01/31/2022 and evidenced the following: A document titled "Home Health Certification and Plan of Treatment" for the certification period 12/02/2021 through 02/09/2022 with orders for "SN [skilled nursing] up to 8 hours daily 3-5XWX9W [3-5 times per week time 9 weeks]." 7. During an interview on 1/31/2022 at 2:56 p.m., the administrator stated she didn't realize using "up to" in the frequency was like using the number zero and was thinking it was a range but understands how it can be seen as zero now.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to provide a copy of written instructions to the patient and caregiver for 1 of 3 home visit observations. (Patient 4) Findings include: A revised 2014 policy titled was provided by the Administrator on 2/1/2022 at 9:30 a.m. The policy indicated, but was not limited to, “1. … staff will provide verbal and written information to the patient” During a home visit on 02/01/2022 11:00 a.m. asked to review patient 4 medication list or admission packet. At that time, personal attendant care G indicated patient 4 does not have an admit packet with a list of medication, consents, or visit frequencies for review.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide a written schedule that included visit frequency for 1 of 3 home visits with the potential to affect all active patients. (Patient 4) Findings include: A revised 2014 policy titled Admission Information was provided by the Administrator on 1/31/2022 at 9:30 a.m. The policy indicated, but was not limited to, “the Agency will provide each patient and family with written information ...” During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G and patient 4 indicated the agency did not provide an admit packet that contained a written schedule with visit frequency, bill of rights, and a copy of signed consent forms when asked.

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 record review and interview, the agency failed to ensure patients received written information regarding the patient's medication regimen in plain language which also identified who was responsible for giving each medication for 3 of 3 home visit observations (Patient 3, 4, 6) with the potential to affect all patients. Finding include: 1. The document titled “Plan of Care” for patient 3 indicated, but was not limited to; “Ibuprofen suspension 100Mg [Milligrams] /5mL [Milliliters] 10 mL Q6HR [Every 6 hours] PRN [as needed] G-Tube(N), Trileptal [Medication used to treat seizures] 300Mg/5ML 10 mL BID [Twice a day] G-Tube(C), Vimpat [Medication used to treat seizures] 10Mg/mL 12 mL BID G-Tube(N), Topamax [Medication used to treat seizures] 125 Mg 1 Tab BID G-Tube(L/S) … “ 2. During a home visit on 02/01/2022 for patient 3, no medication information in plain language provided by the agency was evidenced. A review of the admission packet for patient 3 evidenced a plan of care with patient 3’s medications but failed to include plain language and failed to include which medications the home health agency would administer versus which medication the skilled nurse would administer. 3. During an interview on 02/01/2022 with Licensed Practical Nurse (LPN) M at 12:40 p.m. the LPN indicated they administered Vimpat, Trileptal, and Topamax each day with patient 3’s tube feeds. LPN indicated they alternate days giving the patient Senna and coordinate with the patient’s mother each day on giving it. 4. During a home visit on 01/31/2022 at 3:10 p.m. reviewed patient 6’s medication list. No medication in plain language provided by the agency was evidenced. At that time, patient 6’s parent was interviewed and stated he/she gives all of patient 6’s medication except for DepoProvera. 5. Review of patient 6’s Medication Profile while in the home indicated the following: “Cogentin [medication for stiffness or tremors] 0.5 mg [Milligrams] tab [tablet] PO [by mouth] BID [twice a day], Catapress [treat high blood pressure] 0.1 mg 1 tab [one tablet] PO [by mouth] BID [twice a day], Melatonin [sleep medication] 10mg [milligrams] 1 tab [one tablet] PO [by mouth] hs [bedtime], Diastat gel [seizure medication] 10mg [milligrams] rectally prn [as needed], Depakote [seizure medication] EC [enteric coating] 125 mg [milligrams] ii tabs [two tabs] TID [three times a day], Depakote [seizure medication] EC [enteric coating] 500 mg [milligrams] i tabs [one tabs] TID [three times a day], Haldol [mood/behavior medication] 5 mg[milligrams] i tab [one tablet] PO [by mouth], Nystatin cream [fungus medication] topical to affected areas BID [twice a day] prn [as needed], Phenobarbital [seizure/anxiety medication] 64.8 mg [milligrams] tab ii [two tablets] PO [by mouth], Topamax [seizure medication] 100 mg [milligrams] i tab [one tablet] PO [by mouth], Topamax [seizure medication] 25 mg [milligrams] i tab [one tablet] PO [by mouth] QHS [every bedtime], DepoProvera [hormone blocker] 150 mg [milligrams] IM [injection in the muscle] Q3M [every three months]” 6. During a home visit on 02/01/2022 11:00 a.m. asked to review patient 4 medication list or admission packet. At that time, personal attendant care G indicated patient 4 does not have an admit packet with a list of medication, consents, or visit frequencies for review. 7. During an interview on 2/7/2022 at 12:30 p.m. the Administrator indicated he/she has not provided patients with written medication instructions in plain language for the last 25 years.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to narrow the scope of the quality assessment performance improvement (QAPI) program to concentrate on infection control issues that would lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients for 1 of 1 QAPI program review. Findings include: Review of the agency QAPI program for 2022, 2021, 2020 failed to develop a coordinated agency-wide program to prevent, track, and control the spread of the COVID-19 virus. The agency failed to follow standard precautions to prevent the spread of COVID-19 including, but not limited to, failing to screen patients prior to performing home visits, failing to screen staff prior to patient contact, failing to wear a facial covering while providing patient care, and failing to follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control. During interviews on 01/31/2022 and 02/01/2022 with the Administrator, Alternate Administrator, RN C, HHA K, personal care attendant G, and licensed practical nurse (LPN) M, all indicated they do not pre-screen patients for signs and symptoms of COVID-19 prior to performing patient care, they do not pre-screen and document absence of symptoms of COVID-19 for themselves prior to providing care, and they do not wear facial coverings while providing care.

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: An Immediate Jeopardy related to §484.70 Infection Prevention and Control was identified and announced on 2/2/2022 at 9:37 a.m. The immediate jeopardy was unremoved at the survey exit date of 02/07/2022 at 12:50 p.m. The immediate jeopardy began on March 20th, 2020. On January 31, 2020, the Secretary of Health and Human Services determined that a Public Health Emergency (PHE) existed, and on March 13, 2020, the President declared a national emergency due to the SARS-CoV-2 (COVID-19) pandemic, which triggered the Secretary’s ability to authorize waivers or modifications of certain requirements pursuant to section 1135 of the Social Security Act under section 1135(b)(5). On March 20, 2020, the Center for Medicaid, and Medicare Services (CMS) issued the “QSO 20-20-All” memorandum, which introduced the focused infection control (FIC) survey tool. The FIC survey tool was and is available to every provider in the country to make them aware of infection control priorities during the COVID-19 pandemic. The tool, following the Center for Disease Control (CDC) guidelines, indicated specifically, “facilities should have a screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with known or suspected COVID-19. CDC recommends options for screening symptoms that include but are not limited to screening questions with an assessment of illness, self-monitored pre-arrival temperature checks with the reported absence of fever and symptoms, and facility-monitored temperature checks upon arrival.” CDC notes that “although screening for symptoms will not identify asymptomatic or pre-symptomatic individuals with SARS-CoV-2 infection, symptom screening remains an important strategy to identify those who could have COVID-19 so appropriate precautions can be implemented.” Based on observation, record review, and interview, the agency failed to develop a coordinated agency-wide program to prevent, track, and control the spread of the COVID-19 virus. The agency failed to follow standard precautions to prevent the spread of COVID-19 including, but not limited to, failing to screen patients prior to performing home visits, failing to screen staff prior to patient contact, failing to wear a facial covering while providing patient care, and failing to follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control (See G0680); failed to ensure staff wore proper personal protective equipment (PPE) to prevent the transmission of COVID-19 (infectious disease) during a pandemic with the potential to affect all patients since March 20, 2020. (See G682); failed to implement a screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with known or suspected COVID-19 and failed to ensure staff self-screened prior to home visits with the potential to affect all patients since March 20th of 2020 and failed to maintain an agency-wide program for surveillance, identification, prevention, control, and investigation, of COVID-19 within the agency's quality assessment and performance improvement (QAPI) program (See G684); and failed to educate staff and patients on Covid-19 infection control and preventative guidelines, and failed to write agency policies on Covid-19 that are based on current standards of practice (See G686). The cumulative effect of this systemic problem resulted in the agency being out of compliance with 484.70 Condition of participation: Infection prevention and control. Findings include: Review of an undated policy titled Standard Precautions provided by the Administrator on 1/31/2022 at 1:30 p.m. indicated, but was not limited to, “2. … Masks and protective eyewear or face shields will be worn during procedures that are likely to generate droplets of blood or other body fluids to prevent exposure of mucous membranes of the mouth, nose and eyes. Gowns or aprons and shoe covers will be worn during procedures that are likely to generate splashes of blood and other body fluids … 7. Standard Precautions will be followed for all patients. Isolation precautions will be used as necessary …" On 1/31/2022 at 9:52 a.m. arrived at the agency, door locked, and signage posted of a closed- door policy. No staff available at agency. At 9:55 a.m. unmasked Alternate Clinical Supervisor/Registered Nurse (RN) C arrived and announced the agency was closed due to a COVID-19 surge among office personnel and would make a phone call to the Administrator regarding how to proceed with the survey. At 10:00 a.m. entered agency office along with the RN C. RN C did not screen state surveyors for Covid-19. RN C provided items for the survey while unmasked. RN C indicated the Administrator was on day 10 of quarantine. The agency failed to implement a screening process for any visitors entering the agency to mitigate the risk of COVID-19 exposure such as asking questions, assessment of symptoms/illness, and documentation. On 1/31/2022 at 10:25 a.m. the Administrator arrived unmasked and stated he/she did not feel well and was coughing but would proceed with the survey. The unmasked Administrator sat approximately 2 feet away from unmasked RN C and masked surveyors during entrance conference. The Administrator failed to follow current quarantine and isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control. Registered Nurse (RN) C tested positive for COVID-19 on 01/14/2022. Clinical record review for patient 1 and patient 2, who both live together, indicated RN C provided care without a mask for patient 1 on 01/14/2022. The agency failed to indicate if RN C self-screen was done and failed to indicate if patients 1 & 2 were pre-screened prior to the home visit. The agency failed to evidence patient 1, and patient 2 were notified of their exposure to COVID-19. On 1/31/2022 at 11:45 a.m. unmasked RN C was asked to call patient 8 to set-up a home visit observation on 2/1/2022 along with home health aide (HHA) H. The surveyor was informed by RN C that patient 8 had a cough since Saturday 1/29/2022 and his/her physician called in medication to the pharmacy. At that time RN C was unsure if patient 8 was tested for Covid-19 and decided to call patient 8 back and instruct him/her to go to a clinic to get tested. RN C indicated patient 8 would not go to the clinic to get tested. RN C indicated that patient 2 had an extra Covid-19 test kit at the home he/she could use, or he/she may have to buy one. On 01/31/2022, RN C failed to follow COVID-19 prevention guidelines and entered patient 8’s home unmasked to test the patient for COVID-19. Subsequently, patient 8 tested positive for COVID-19 that day. RN C then returned to the agency office and continued to work unmasked. The agency failed to take responsibility for their safety and the health and safety of those around them by taking appropriate preventative measures to prevent the spread of COVID-19. The Alternate Administrator tested positive for COVID-19 on 01/24/2022. The Alternate Administrator was in the office unmasked on days 7, 8, and 9 (01/31/2022, 02/01/2022, and 02/02/2022) of their required quarantine and isolation period. The Administrator tested positive for COVID-19 on 01/22/2022. The Administrator provided care for patient 1 on 01/22/2022 and 01/23/2022. The agency failed to evidence patient 1 and patient 2 were notified of their exposure to COVID-19. The unvaccinated Administrator was in the office unmasked while symptomatic on day 9 and 10 (01/31/2022 & 02/01/2022) of their required quarantine and isolation period exposing unmasked RN C, unmasked Alternate Administrator, and 2 masked state employees, to COVID-19. On 1/31/2022 at 12:50 p.m. the Alternate Administrator was asked why patient 6 was not on the agency schedule for home visits. The Alternate Administrator indicated patient 6 tested positive last week and was unsure of the exact date. The Alternate Administrator indicated patient 6 went to school last Friday 1/28/2022 so the patient must be clear. At 3:00 p.m. the Alternate Administrator was unsure of the exact date when HHA K tested positive for Covid but was notified by text on 1/26/2022. On 1/31/2022 at 2:30 p.m. the Administrator was asked if there was a plan in place regarding Covid vaccinations for staff. The Administrator indicated he/she was working on it. The Administrator indicated there were unvaccinated employees providing care to patients. During a home visit on 1/31/2022 at 3:10 p.m. home health aide (HHA) K was observed sitting next to patient 6 on the couch without a mask. Patient 6’s mother was sitting in a chair less than 3 feet away from the couch without a mask. HHA K indicated the agency does not require him/her to wear a mask during the home visit even though a mask was available. HHA K and patient 6’s mother indicated the agency provided education to them but was not specific as to what was taught. HHA K indicated he/she does not screen him/herself nor document absence of Covid-19 signs or symptoms prior to each home visit. HHA K does not screen the patient for Covid-19 prior to entering the home. Home Health Aide (HHA) K tested positive for COVID-19 on 01/26/2022. Record review for patient 6 indicated HHA K provided care unmasked for patient 6 on 01/26/2022, 01/27/2022, 01/28/2022, and 1/31/2022 while knowingly positive for COVID-19. No documentation existed evidencing patient 6 was notified and permission was obtained for HHA K to provide care without proper protective equipment for patient 6. The agency failed to take responsibility for their safety and the health and safety of those around them by taking appropriate preventative measures to prevent the spread of COVID-19. During interviews on 01/31/2022 and 02/01/2022 with the Administrator, Alternate Administrator, RN C, HHA K, personal care attendant G, and licensed practical nurse (LPN) M, all indicated they do not pre-screen patients for signs and symptoms of COVID-19 prior to performing patient care, they do not pre-screen and document absence of symptoms of COVID-19 for themselves prior to providing care, and they do not wear facial coverings while providing care. Review of the agency’s COVID-19 binder provided by the Administrator on 01/31/2022 indicated the binder had not been updated since November of 2020 and did not contain the most recent Center for Disease Control (CDC) recommended guidelines. During an interview on 01/31/2022 at 1:59 p.m., the Administrator indicated the agency followed guidelines set forth by the CDC and no one has time to write policies with every change. During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G was observed unmasked, providing services for patient 5. Personal attendant care G indicated the agency did not provide a mask nor require a mask to be worn during the home visit. At that time, personal attendant care G indicated he/she does not screen him/herself nor document absence of Covid-19 signs or symptoms prior to each home visit. Personal attendant care G does not screen the patient for Covid-19 prior to entering the home. Personal attendant care G indicated the agency did not provide Covid-19 education. The agency failed to follow current state executive orders during a pandemic. During an interview on 02/01/2022 at 12:30 p.m. Licensed Practical Nurse (LPN) M indicated he/she does not screen self or screen patient 3 daily for symptoms of COVID-19 or document the absence of symptoms. LPN M indicated masks are not required nor had the agency provided a mask. LPN M indicated he/she had ordered an N95 mask. LPN M indicated he/she had contracted COVID-19 in August of 2021 and had contracted it from patient 3 whom they were providing care for and subsequently spread the COVID-19 virus to an elderly family member. Personal Care Attendant G came to the office unmasked to pick up documents on 02/01/2022 at 2:06 p.m. while the Administrator and Alternate Administrator were present in the office unmasked during their quarantine and isolation periods. The Administrator and Alternate Administrator were still symptomatic. During an observation of the agency’s supply room on 2/1/2022 at 2:17 p.m. along with the Alternate Administrator confirmed one box of blue mask at the agency was available for staff. No N95 masks were available. The Alternate Administrator indicated he/she reached out to the local health department in December 2021, but none were available and had not checked back. Four boxes of gloves were in the agency’s bathroom cabinet. No face shields, gowns, goggles, or foot coverings were available at the agency for staff to use. During an interview on 02/01/2022 at 4:15 p.m. the Administrator indicated he/she printed updates for COVID-19 and the updates are laying around. The Administrator indicated he/she has not had time to put the updates in a binder and patients would not want staff wearing masks in the home. The agency failed to ensure agency policies and procedures were developed, current, and implemented to ensure staff and patients were screened for COVID-19 prior to patient care and document the absence of the symptoms. The agency failed to have agency specific policies developed for the procedure if a patient had respiratory symptoms, patient/family member tests positive, and if a patient/family member was identified as a close contact. The agency failed to have policies and procedures that identify who will be responsible for notifying close contacts, local, and/or state health officials. The agency failed to provide an agency policy on tracking and surveillance of COVID-19 cases, quarantine, and isolation periods. During an observation on 2/2/2022 between 9:00 a.m. to 10:00 a.m. the Administrator was observed without a mask and symptomatic. The Alternate Administrator was symptomatic. The agency failed to comply with agency policy regarding the use of a mask to prevent the spread of respiratory droplets and failed to comply with an executive order regarding the use of preventative measures to prevent the spread of COVID-19. During an observation on 2/2/2022 at 10:30 a.m. unvaccinated RN C, who was exposed to positive COVID patient 8 on 1/31/2022 was observed at the agency and left to see other staff members in the field. The agency failed to educate RN C on current executive orders that indicate “unvaccinated individuals who are close contacts of a COVID-19 infected person shall quarantine … signed by Eric J. Holcomb under the authority vested as Governor by the Indiana Constitution and the laws of the state of Indiana.” As of 02/02/2022 according to the World Health Organization (WHO), there have been 5,680,741 deaths globally as a result of contracting COVID-19, 880,580 of which occurred in the United States, 20,799 of which occurred in the state of Indiana, and 616 of which occurred in the counties serviced by the agency.

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, record review, and interview, the agency failed to ensure staff wore proper personal protective equipment (PPE) to prevent the transmission of COVID-19 (infectious disease) during a pandemic (worldwide) for 3 of 3 home visit observations (patients 3, 5, & 6) with the potential to affect all patients since March 20, 2020. Findings include: 1. A 2/28/2020 article titled Home Care Instructions for Novel Coronavirus (COVID-19) was provided by the Administrator on 2/2/2022 at 10:05 a.m. The article indicated, but was not limited to, “5. Wear a disposable facemask … 6. Wear a disposable facemask and gloves when you touch or have contact with the patient … 10. Monitor the patient’s symptoms. … 11. Monitor your own health …” 2. A revised 2014 policy titled Professional Standards of Practice was provided by the Administrator on 1/31/2021 at 9:30 a.m. The policy indicated, but was not limited to, “Agency and staff will comply with accepted standards of practice and plans of care.” 3. An Executive Order from the Governor of Indiana titled “For: Further Continuation of Limited Provisions to Address the Impact and Spread of the Coronavirus Disease (COVID-19) indicated, but was not limited to, “ … Individuals who are symptomatic and test negative should isolate until their symptoms have resolved … Fully Vaccinated individuals who are close contacts of a person who tests positive for COVID-19 may continue their normal activities but must wear a mask at all time in public for 10 days and are encouraged to obtain a COVID-19 test 5 days after exposure. Unvaccinated individuals who are close contacts of a COVID-19 infected person shall quarantine … signed by Eric J. Holcomb under the authority vested as Governor by the Indiana Constitution and the laws of the state of Indiana.” 4. On 1/31/2022 at 9:52 a.m. arrived at the agency, door locked, and signage posted of a closed-door policy. No staff is available at the agency. At 9:55 a.m. unmasked Alternate Clinical Supervisor (RN) C, arrived and announced the agency was closed due to a Covid surge among office personnel and would make a phone call to the Administrator regarding how to proceed with the survey. At 10:00 a.m. entered the agency office along with RN C without having screened the surveyors for Covid-19. RN C provided items for the survey while unmasked. RN C indicated the Administrator was on day 10 of quarantine, did not feel well, and had tested negative twice so far. RN C indicated the Alternate Administrator tested positive 7 days ago and was on day 7 of quarantine with improved symptoms. 5. On 1/31/2022 at 10:25 a.m. the Administrator arrived unmasked and stated he/she did not feel well and was coughing but would proceed with the survey. The unmasked Administrator sat approximately 2 feet away from unmasked RN C and masked surveyors during the entrance conference. At 10:41 a.m. when asked how the agency identified patients with COVID-19, the Administrator indicated, for example, they went to a patient’s home and the patient stated he/she had a cold so they tested him/her and were positive for COVID-19 so they knew. 6. On 1/31/2022 at 11:45 a.m. unmasked RN C was asked to call patient 8 to set up a home visit observation on 2/1/2022 along with home health aide (HHA) H. The surveyor was informed by RN C that patient 8 had a cough since Saturday 1/29/2022 and his/her physician called in medication to the pharmacy. At that time RN C was unsure if patient 8 was tested for Covid-19 and decided to call patient 8 back and instruct him/her to go to a clinic to get tested. RN C indicated patient 8 would not go to the clinic to get tested. RN C indicated that patient 2 had an extra Covid-19 test kit at the home he/she could use, or he/she may have to buy one. 7. During an interview on 1/31/2022 at 2:40 p.m. asked the Administrator about a COVID-19 log to which he/she indicated, “I don’t have one, we don’t do it. I know who’s been sick. I can produce something if I need to but no, I don’t have a log.” 8. During a home visit on 1/31/2022 at 3:10 p.m. home health aide (HHA) K was observed sitting next to patient 6 on the couch without a mask. Patient 6’s mother was sitting in a chair less than 3 feet away from the couch without a mask. HHA K indicated the agency does not require him/her to wear a mask during the home visit even though a mask was available. HHA K and patient 6’s mother indicated the agency provided education to them but was not specific as to what was taught. 9. During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G was observed unmasked, providing services for patient 5. Personal attendant care G indicated the agency did not provide a mask nor require a mask to be worn during the home visit. Patient 5 was observed not wearing a mask. 10. During a home visit on 2/1/2022 at 12:30 p.m. licensed practical nurse (LPN) M was observed unmasked, providing services for patient 3. LPN M was observed administering an enteral feed unmasked within 1 foot of the patient. LPN M indicated they are not required to wear masks when providing patient care. When asked about the potential to spread COVID-19 LPN M stated patient 3 had already had COVID-19 and had spread it to LPN M. LPN M stated she did not work while infected with COVID-19. 11. During an observation on 2/1/2022 at 2:06 p.m. at the agency office, observed personal attendant care G enter the agency’s backdoor without a mask. Personal attendant care G met with the Administrator who was unmasked to give him/her papers. Personal attendant care G spoke to the Alternate Administrator who was unmasked, then left the agency. The agency did not screen the personal attendant care G nor ask if he/she had any signs or symptoms of Covid-19. 12. During an observation of the agency’s supply room on 2/1/2022 at 2:17 p.m. the Alternate Administrator confirmed one box of the blue mask at the agency was available for staff. No N95 masks were available. The Alternate Administrator indicated he/she reached out to the local health department in December 2021, but none were available and had not checked back. Four boxes of gloves were in the agency’s bathroom cabinet. No face shields, gowns, goggles, or foot coverings were available at the agency for staff to use. 13. During an interview on 2/1/2022 at 4:30 p.m. the unmasked Administrator was made aware of home visit observations and staff interviews and was unable to provide additional information, comments, or documents. 14. During an observation on 2/2/2022 between 9:00 a.m. to 10:00 a.m. the Administrator was observed without a mask and symptomatic. The Alternate Administrator was symptomatic. The agency failed to comply with agency policy regarding the use of a mask to prevent the spread of respiratory droplets and failed to comply with an executive order regarding the use of preventative measures to prevent the spread of COVID-19. 15. During an observation on 2/2/2022 at 10:30 a.m. unvaccinated RN C, who was exposed to positive COVID patient 8 was observed at the agency and left to see other staff members in the field. The agency failed to educate RN C on current executive orders that indicated “unvaccinated individuals who are close contacts of a COVID-19 infected person shall quarantine … signed by Eric J. Holcomb under the authority vested as Governor by the Indiana Constitution and the laws of the state of Indiana.”

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to implement a screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with known or suspected COVID-19 and failed to ensure staff self-screened prior to home visits for 3 of 3 home visits observations (Patient 3, 5, & 6) and 8 of 8 clinical record reviews (Patients 1, 2, 3, 4, 5, 6, 7, & 8) with the potential to affect all patients since March 20th of 2020; and failed to maintain an agency-wide program for surveillance, identification, prevention, control, and investigation, of COVID-19 within the agency's quality assessment and performance improvement (QAPI) program for 1 of 1 QAPI program review. Findings include: 19. During an interview on 1/31/2022 at 2:40 p.m. asked the Administrator about a COVID-19 log to which he/she indicated, “I don’t have one, we don’t do it. I know who’s been sick. I can produce something if I need to but no, I don’t have a log.” 20. Review of the QAPI binder on 2/1/2022 failed to indicate the agency surveillance, identification, prevention, control, and investigation, of COVID-19. 21. On 2/1/2022 at 2:10 p.m. the Administrator provided documents the Alternate Administrator had that indicated the following: Infection Control Log: Patient Infections: “Date 8/2021 [patient 3] COVID … Date 12/2021 [patient 2] COVID … Date 1/2022 [patient 8] COVID … Date 1/2022 [patient 6] COVID …" Infection Control Log: Employee Infections: “Date 1-22 [RN C] COVID … Date 1-22 [Administrator] … Date 1-22 [HHA K] COVID … Date 1-22 [Alternate Administrator] COVID …" All employee COVID infections were documented as community acquired. The agency failed to accurately record a specific date for each occurrence of COVID and failed to accurately track, follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control. Findings include: 1. On March 20, 2020, the Center for Medicaid, and Medicare Services (CMS) issued the “QSO 20-20-All” memorandum, which introduced the focused infection control (FIC) survey and tool. The FIC survey tool was available to every provider in the country to make them aware of infection control priorities during the COVID-19 pandemic. The tool, following the Center for Disease Control (CDC) guidelines, indicates specifically, “facilities should have a screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with known or suspected COVID-19. CDC recommends options for screening symptoms that include but are not limited to screening questions with an assessment of illness, self-monitored pre-arrival temperature checks with the reported absence of fever and symptoms, and facility-monitored temperature checks upon arrival.” 2. On 1/31/2022 at 9:52 a.m. arrived at the agency, door locked, and signage posted of a closed-door policy. No staff is available at the agency. At 9:55 a.m. unmasked Alternate Clinical Supervisor/Registered Nurse (RN) C arrived and announced the agency was closed due to a COVID-19 surge among office personnel and would make a phone call to the Administrator regarding how to proceed with the survey. At 10:00 a.m. entered the agency office along with the RN C. RN C did not screen state surveyors for Covid-19. RN C provided items for the survey while unmasked. RN C indicated the Administrator was on day 10 of quarantine. The agency failed to implement a screening process for any visitors entering the agency to mitigate the risk of COVID-19 exposure such as asking questions, assessment of symptoms/illness, and documentation. 3. On 1/31/2022 at 10:25 a.m. the Administrator arrived unmasked and stated he/she did not feel well and was coughing but would proceed with the survey. The unmasked Administrator sat approximately 2 feet away from unmasked RN C and masked surveyors during the entrance conference. At 10:41 a.m. when asked how the agency identified patients with COVID-19, the Administrator indicated, for example, they went to a patient’s home and the patient stated he/she had a cold so they tested him/her and were positive for COVID-19 so they knew. 4. During an interview on 1/31/2022 at 2:40 p.m. asked the Administrator about a COVID-19 log to which he/she indicated, “I don’t have one, we don’t do it. I know who’s been sick. I can produce something if I need to but no, I don’t have a log.” 5. During a home visit on 1/31/2022 at 3:10 p.m. home health aide (HHA) K was observed sitting next to patient 6 on the couch without a mask. Patient 6’s mother was sitting in a chair less than 3 feet away from the couch without a mask. HHA K indicated the agency does not require him/her to wear a mask during the home visit even though a mask was available. HHA K and patient 6’s mother indicated the agency provided education to them but was not specific as to what was taught. HHA K indicated he/she does not screen him/herself nor document the absence of Covid-19 signs or symptoms prior to each home visit. HHA K does not screen the patient for Covid-19 prior to entering the home. 6. During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G was observed unmasked, providing services for patient 5. Personal attendant care G indicated the agency did not provide a mask nor require a mask to be worn during the home visit. Patient 5 was observed not wearing a mask, tobacco matter in the beard, chair, and on the floor. Patient 5 had dark matter underneath all fingernails. At that time, personal attendant care G indicated he/she does not screen him/herself nor document the absence of Covid-19 signs or symptoms prior to each home visit. Personal attendant care G does not screen the patient for Covid-19 prior to entering the home. Personal attendant care G indicated the agency did not provide Covid-19 education but if he/she suspected the patient had Covid, he/she would immediately go outside, call the Administrator or Alternate Administrator, then make an appointment to get tested. 7. During an observation on 2/1/2022 at 2:06 p.m. at the agency office, observed personal attendant care G enter the agency’s backdoor without a mask. Personal attendant care G met with the Administrator who was unmasked to give him/her papers. Personal attendant care G spoke to the Alternate Administrator who was unmasked, then left the agency. The agency did not screen the personal attendant care G nor ask if he/she had any signs or symptoms of Covid-19. 8. The complete clinical record for patient 1 was reviewed on 2/1/2021, the start of care date 06/09/2020, certification period 12/1/2021 to 1/29/2022, with orders for skilled nursing services 1-2 times a week for 9 weeks and home health aide services 1-3 times per day times 7 days a week for 9 weeks. A review of the home visit Progress Notes dated for the week of 12/09/2021 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. A review of the home visit Progress Notes dated for the week of 12/13/2021 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. A review of the home visit Progress Notes dated for the week of 12/21/2021 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. A review of the home visit Progress Notes dated for the week of 12/27/2021 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. A review of the home visit Progress Notes dated for the week of 01/03/2022 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. A review of the home visit Progress Notes dated for the week of 01/10/2022 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. 9. The complete clinical record for patient 2 was reviewed on 2/1/2021, the start of care date 11/03/2014, certification period 11/25/2021 to 1/23/2022, with orders for skilled nursing visits 1-4 times per day 5-7 times per week for 9 weeks and home health aide services up to 10 hours per day 7 days per week for 9 weeks. A review of the home visit Progress Notes dated for the weeks ending 11/27/2021, 12/06/2021, 12/11/2021, 12/18/2021, 12/25/2021, 01/01/2022, 01/08/2022, 01/15/2022, and 01/22/2022 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. 10. The complete clinical record for patient 3 was reviewed on 2/1/2021, the start of care date 12/17/2020, certification period 12/12/2021 to 2/09/2022, with orders for skilled nursing visits up to 8 hours per day 3-5 times per week for 9 weeks. A review of the home visit Progress Notes dated for the weeks ending 12/18/2021, 12/25/2021, 01/01/2022, 01/08/2022, 01/15/2022, and 01/22/2022 failed to indicate Covid-19 screens were done on patient 1 prior to each home visit. 11. During an interview on 02/01/2022 at 12:30 p.m.., Licensed Practical Nurse (LPN) M stated they do not screen themselves or patients daily for symptoms of COVID-19 and document the absence of symptoms. LPN M stated masks are not required, and they have not been provided a mask by the agency but have ordered their own N95 mask. LPN M indicated they had contracted COVID-19 in August of 2021 and they had contracted it from patient 3 whom they were providing care for and subsequently spread the COVID-19 virus to an elderly family member. 12. The complete clinical record for patient 4 was reviewed on 1/31/2022 and 2/1/2022, the start of care date 8/30/2021, certification period 8/30/2021 to 10/21/2021, with orders for attendant care services 1-3 times a week for 9 weeks. Review of the home visit Progress Notes dated for the week of 12/27/2021 to 12/31/2021; week of 1/3/2022 to 1/7/2022; week of 1/10/2022 to 1/14/2022; and week of 1/17/2022 to 1/21/2022 failed to indicate Covid-19 screens were done on patient 4 prior to each home visit. 13. The complete clinical record for patient 5 was reviewed on 2/1/2022, the start of care date 8/30/2021, certification period 10/29/2021 to 12/27/2021, with orders for attendant care services 1-3 times a week for 9 weeks. Review of the home visit Progress Notes dated for the week of 10/31/2021 to 11/6/2021; week of 11/7/2021 to 11/13/2021 failed to indicate Covid-19 screens were done on patient 5 prior to each home visit. Review of the home visit Progress Notes dated for the week of 12/13/2021 to 11/18/2021 and for the week of 12/19/2021 to 12/25/2021 failed to indicate Covid-19 screens were done on patient 5 prior to each home visit. 14. The complete clinical record for patient 6 was reviewed on 2/1/2022, the start of care date 11/23/2021, certification period 11/23/2021 to 1/21/2021, with orders for skilled nurse supervision and home health aide up to 10 hours a day 2-5 days a week for 9 weeks. Review of the home visit Progress Notes dated for the week of 12/27/2021 to 12/31/2021; week of 1/3/2022 to 1/7/2022; week of 1/10/2022 to 1/14/2022; and week of 1/17/2022 to 1/22/2022 failed to indicate Covid-19 screens were done on patient 6 prior to each home visit. 15. The complete clinical record for patient 7 was reviewed on 2/1/2022, start of care date 3/3/2021, certification period 3/3/2021 to 5/1/2021, with orders for physical therapy 2 times a week for 4 weeks. Review of the home visit Progress Notes dated for the week of 3/3/2021 to 3/6/2021; week of 3/7/2021 to 3/13/2021; week of 3/14/2021 to 3/23/2021; week of 3/21/2021 to 3/27/2021; and week of 3/28/2021 to 3/31/2021 failed to indicate Covid-19 screens were done on patient 7 prior to each home visit. 16. The complete clinical record for patient 8 was reviewed on 2/1/2021, start of care date 11/19/2021, certification period 12/7/2021 to 2/4/2022, with orders for skilled nurse supervision and home health aide 1-2 times a week for 9 weeks. Review of the home visit Progress Notes dated for the week of 12/7/2021 to 12/11/2021; week of 12/12/2021 to 12/18/2021; week of 12/19/2021 to 12/25/2021; week of 12/26/2021 to 1/1/2022; week of 1/02/2022 to 1/8/2022; week of 1/9/2022 to 1/15/2022; week of 1/16/2022 to 1/22/2022; and week of 1/23/2022 to 1/29/2022 failed to indicate Covid-19 screens were done on patient 8 prior to each home visit. 17. During an interview on 2/1/2022 at 4:30 p.m. the Administrator indicated staff do not self-screen and document the absence of Covid-19 and do not screen patients for Covid-19 prior to home visits or document the absence of Covid-19 signs or symptoms. 18. The agency failed to screen the surveyors for Covid-19 on survey days 1/31/2022, 2/1/2022, and 2/2/2022.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to educate staff and patients on Covid-19 infection control and preventative guidelines for 3 of 3 home visit observations (Patient 3,5,6); and failed to write agency policies on Covid-19 that were based on current standards of practice for 1 of 1 home health agency. 1. A 7/20/2020 document titled Home Care Infection Control Guidance Concerning COVID-19 was provided by RN C on 1/31/2022 at 1:48 p.m. The document indicated, but was not limited to, “1. When making a home visit, identify clients at risk for having COVID-19 before or immediately upon arrival to the home. The client and any other person who will be in the home during the appointment … should be carefully screened for the following: a) Fever or respiratory symptoms (cough, shortness of breath or sore throat) b) Close contact with a suspect or confirmed person with COVID-19 c) Travel from a COVID-19 affected community or geographic area with in 14 days d) Residing in a community where community-based spread of COVID-19 is occurring” 2. An undated policy titled Standard Precautions was provided by the Administrator on 1/31/2022 at 1:30 p.m. The policy indicated, but was not limited to, “2. … Masks and protective eyewear or face shields will be worn during procedures that are likely to generate droplets of blood or other body fluids to prevent exposure of mucous membranes of the mouth, nose and eyes. Gowns or aprons and shoe covers will be worn during procedures that are likely to generate splashes of blood and other body fluids … 7. Standard Precautions will be followed for all patients. Isolation precautions will be used as necessary …" 3. On March 20, 2020, the Center for Medicaid, and Medicare Services (CMS) issued the “QSO 20-20-All” memorandum, which introduced the focused infection control (FIC) survey and tool. The FIC survey tool was and is available to every provider in the country to make them aware of infection control priorities during the COVID-19 pandemic. The tool, following the Center for Disease Control (CDC) guidelines, indicated that facilities should have an established facility-wide infection prevention and control program that included written standards, policies, and procedures that are current and based on national standards for undiagnosed respiratory illness and COVID-19. The facility should have policies or procedures that include when to notify local/state public health officials if there are clusters of respiratory illness or cases of COVID-19 that are identified or suspected. The facilities concerns must be corroborated as applicable including the review of pertinent policies/procedures as necessary. 4. During a home visit on 1/31/2022 at 3:10 p.m. home health aide (HHA) K was observed sitting next to patient 6 on the couch without a mask. Patient 6’s mother was sitting in a chair less than 3 feet away from the couch without a mask. HHA K indicated the agency does not require him/her to wear a mask during the home visit even though a mask was available. HHA K and patient 6’s mother indicated the agency provided education to them but was not specific as to what was taught. HHA K indicated he/she does not screen him/herself nor document absence of Covid-19 signs or symptoms prior to each home visit. HHA K does not screen the patient for Covid-19 prior to entering the home. 5. During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G was observed unmasked, providing services for patient 5. Personal attendant care G indicated the agency did not provide a mask nor require a mask to be worn during the home visit. At that time, personal attendant care G indicated he/she does not screen him/herself nor document absence of Covid-19 signs or symptoms prior to each home visit. Personal attendant care G does not screen the patient for Covid-19 prior to entering the home. Personal attendant care G indicated the agency did not provide Covid-19 education but if he/she suspected the patient had Covid, he/she would immediately go outside, call the Administrator or Alternate Administrator, then make an appointment to get tested. 6. Review of the agency’s COVID-19 binder on 01/31/2020 indicated the binder had not been updated since November of 2020 and did not contain the most recent Center for Disease Control (CDC) recommended guidelines. 7. During an interview on 01/31/2022 at 1:59 p.m., the Administrator indicated the agency follows guidelines set forth by the CDC and no one has time to write policies with every change. 8. During an interview on 02/01/2022 at 4:15 p.m. the Administrator indicated he/she printed updates for COVID-19 and the updates are laying around. The Administrator indicated he/she has not had time to put the updates in a binder and patients would not want staff wearing masks in the home.

Administrator must: CFR(s): 484.105(b)(1) Standard: Administrator. The administrator must: This STANDARD is not met as evidenced by: Based on record review, the administrator failed to provide overall direction and leadership of agency services, failed to ensure the agency met all rules and regulations for recertification, and failed ensure the responsibility for all day-to-day operations for 1 of 1 home health agency. Findings include: The agency Administrator failed to implement and maintain an emergency preparedness plan and failed to follow all local and state emergency preparedness regulations. (see tag E0004) The agency Administrator failed to implement and have established policies and procedures for the Coronavirus (COVID-19) pandemic while the state is under a Public Health Emergency as a result of the COVID-19 virus and has been since March, 6th 2020. (see tag E0013) The agency Administrator failed to ensure the emergency preparedness plan contained the names and contact information for all staff, patients, physicians, and other entities providing services was integrated into the emergency preparedness binder. (see tag E0030) The agency Administrator failed to ensure patients were informed of factors that could affect their health during a pandemic. (see tag G434) The agency Administrator failed to ensure all services outlined in the plan of care was received. (see tag G436) The agency Administrator failed to provide care with a reasonable expectation that a patient’s health needs could be meet. (see tag G570) The agency Administrator failed to ensure the plan of care included the visit frequency and duration of services. (see tag G574) The agency Administrator failed to provide a copy of written instructions to the patient and caregiver. (see tag G612) The agency Administrator failed to provide a written schedule that included visit frequency. (see tag G614) The agency Administrator failed to ensure that patients received written information regarding the patient's medication regimen in plain language with the potential to affect all patients. (see tag G616) The agency Administrator failed to narrow the scope of the quality assessment performance improvement (QAPI) program to concentrate on infection control issues that would lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients for the program review. (see tag G652) The agency Administrator failed to ensure that patients received written information regarding the patient's medication regimen in plain language with the potential to affect all patients. (see tag G660) The agency Administrator failed to remove an Immediate Jeopardy related to §484.70 Infection Prevention and Control at the survey exit date of 02/07/2022 at 12:50 p.m. (see tag G680) The agency Administrator failed to ensure staff wore proper personal protective equipment (PPE) to prevent the transmission of COVID-19 (infectious disease) during a pandemic (worldwide) with the potential to affect all patients since March 20, 2020. (see tag G682) The agency Administrator failed to educate staff and patients on Covid-19 infection control and preventative guidelines and failed to write agency policies on Covid-19 that are based on current standards of practice. (see tag G684) The agency Administrator failed to implement a screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with known or suspected COVID-19 and failed to ensure staff self-screened prior to home visits with the potential to affect all patients since March 20th of 2020; and failed to maintain an agency-wide program for surveillance, identification, prevention, control, and investigation, of COVID-19 within the agency's quality assessment and performance improvement (QAPI) program. (see tag G684) The agency Administrator failed to educate staff and patients on Covid-19 infection control and preventative guidelines for 3 of 3 home visit observations (Patient 3,5,6); and failed to write agency policies on Covid-19 that are based on current standards of practice. (see tag G686) The agency Administrator failed to ensure all services were provided in accordant with clinical practice guidelines and accepted professional standards of practice. (see tag G984) The agency Administrator failed to complete clinical documentation for patients that were exposed to COVID-19 and failed to document the tracking and follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control with the potential to affect all patients. (see tag G1024)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all services were provided in accordance with clinical practice guidelines and accepted professional standards of practice for 3 of 3 home visit observation (Patient 3,4,6); and for 4 of 4 agency staff observations (1/31/22-2/2/2022) Findings include: A document titled "Mic-Key Care Guide" was provided by the administrator on 02/01/2022. The document indicated, but was not limited to; "Before feeding, check the tube placement to be sure that it is not clogged or displaced outside the stomach. To do this, connect the extension set to the Mic-Key feeding tube and attach a monoject catheter tip syringe with 10 ml's of water to the extension set feeding port. Pull back on the plunger. When you see stomach contents in the tube, flush the Mic-key feeding tube with water … another method is to draw 5 to 10 ml's of air with a syringe. Place a stethoscope on the left side of the abdomen just above the waist. Inject the air into the extension set feeding port and listen for the stomach to "growl"/ Try again if you do not hear it … " During an observation on 2/01/2022 at 12:40 p.m. Licensed Practical Nurse (LPN) M was observed preparing a tube feed. LPN M performed hand hygiene, prepared patient 3's formula, connected the formula to the extension port and administered the feed. LPN M failed to verify the placement of the Mic-Key tube (a tube administered into the stomach through the abdominal wall to allow for the intake of food and water) prior to administering the feed. During an interview on 2/01/2022 at 12:50 p.m. when asked how the LPN knew the tube was in the correct location LPN M stated they should have verified placement and usually do. LPN M stated they usually would inject air and listen with their stethoscope to verify placement. 1. A 2/28/2020 article titled Home Care Instructions for Novel Coronavirus (COVID-19) was provided by the Administrator on 2/2/2022 at 10:05 a.m. The article indicated, but was not limited to, “5. Wear a disposable facemask … 6. Wear a disposable facemask and gloves when you touch or have contact with the patient … 10. Monitor the patient’s symptoms. … 11. Monitor your own health …” 2. A revised 2014 policy titled Professional Standards of Practice was provided by the Administrator on 1/31/2021 at 9:30 a.m. The policy indicated, but was not limited to, “Agency and staff will comply with accepted standards of practice and plans of care.” 3. An Executive Order from the Governor of Indiana titled “For: Further Continuation of Limited Provisions to Address the Impact and Spread of the Coronavirus Disease (COVID-19) indicated, but was not limited to, “ … Individuals who are symptomatic and test negative should isolate until their symptoms have resolved … Fully Vaccinated individuals who are close contacts of a person who tests positive for COVID-19 may continue their normal activities but must wear a mask at all time in public for 10 days and are encouraged to obtain a COVID-19 test 5 days after exposure. Unvaccinated individuals who are close contacts of a COVID-19 infected person shall quarantine … signed by Eric J. Holcomb under the authority vested as Governor by the Indiana Constitution and the laws of the state of Indiana.” 4. On 1/31/2022 at 10:00 a.m. entered agency office along with the RN C without having screened the surveyors for Covid-19. RN C provided items for the survey while unmasked. 5. On 1/31/2022 at 10:25 a.m. the Administrator arrived unmasked and stated he/she did not feel well and was coughing but would proceed with the survey. The unmasked Administrator sat approximately 2 feet away from unmasked RN C and masked surveyors during entrance conference. 6. During a home visit on 1/31/2022 at 3:10 p.m. home health aide (HHA) K was observed sitting next to patient 6 on the couch without a mask. Patient 6’s mother was sitting in a chair less than 3 feet away from the couch without a mask. HHA K indicated the agency does not require him/her to wear a mask during the home visit even though a mask was available. 7. During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G was observed unmasked, providing services for patient 5. Personal attendant care G indicated the agency did not provide a mask nor require a mask to be worn during the home visit. 8. During a home visit on 2/1/2022 at 12:30 p.m. licensed practical nurse (LPN) M was observed unmasked, providing services for patient 3. LPN M was observed administering an enteral feed unmasked within 1 foot of the patient. LPN M indicated they are not required to wear masks when providing patient care. 9. During an observation on 2/1/2022 at 2:06 p.m. at the agency office, observed personal attendant care G enter the agency’s backdoor without a mask. Personal attendant care G met with the Administrator who was unmasked to give him/her papers. Personal attendant care G spoke to the Alternate Administrator who was unmasked, then left the agency. The agency did not screen the personal attendant care G nor ask if he/she had any signs or symptoms of Covid-19. 10. During an interview on 2/1/2022 at 4:30 p.m. the unmasked Administrator was made aware of home visit observations and staff interviews and were unable to provide additional information, comments, or documents. 11. During an observation on 2/2/2022 between 9:00 a.m. to 10:00 a.m. the Administrator was observed without a mask and symptomatic. The Alternate Administrator was symptomatic. The agency failed to comply with agency policy regarding the use of a mask to prevent the spread of respiratory droplets and failed to comply with an executive order regarding the use of preventative measures to prevent the spread of COVID-19.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to complete clinical documentation for patients that were exposed to COVID-19 for 3 of 3 record reviews of patients exposed to COVID-19 (Patient 1,2,6); and failed to document the tracking and follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control for 8 of 8 patient record reviews (Patient 1,2,3,4,5,6,7,8) with the potential to affect all patients. Findings include: 1. On March 20, 2020, the Center for Medicaid, and Medicare Services (CMS) issued the “QSO 20-20-All” memorandum, which introduced the focused infection control (FIC) survey and tool. The FIC survey tool was available to every provider in the country to make them aware of infection control priorities during the COVID-19 pandemic. The tool, following the Center for Disease Control (CDC) guidelines, indicates specifically, “facilities should have a screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with known or suspected COVID-19. CDC recommends options for screening symptoms that include but are not limited to screening questions with an assessment of illness, self-monitored pre-arrival temperature checks with the reported absence of fever and symptoms, and facility-monitored temperature checks upon arrival.” 2. A document titled, TITLE 410 INDIANA STATE DEPARTMENT OF HEALTH indicated, but was not limited to, "410 IAC 1-2.5 to add definitions, reporting requirements, dangerous communicable diseases, disease intervention, measures, general and specific control measures, and documents incorporated by reference. ... Active surveillance means taking any measures to identify all cases of an infectious disease … calling or otherwise contacting: … others who might be aware of cases of disease … 410 IAC 1-2.5-77 Disease intervention measures; responsibility to investigate and implement … e) … each individual case investigation shall be documented, in writing … “ 3. During a home visit on 1/31/2022 at 3:10 p.m. HHA K indicated he/she does not screen him/herself nor document the absence of Covid-319 signs or symptoms prior to each home visit. HHA K does not screen the patient for Covid-19 prior to entering the home. 4. During a home visit on 2/1/2022 at 11:00 a.m. personal attendant care G indicated he/she does not screen him/herself nor document the absence of Covid-19 signs or symptoms prior to each home visit. Personal attendant care G does not screen the patient for Covid-19 prior to entering the home. 5. During a home visit on 02/01/2022 at 12:30 p.m.., Licensed Practical Nurse (LPN) M stated they do not screen themselves or patients daily for symptoms of COVID-19 and document the absence of symptoms. 6. Home Health Aide (HHA) K tested positive for COVID-19 on 01/26/2022. Record review for patient 6 indicated HHA K provided care unmasked for patient 6 on 01/26/2022, 01/27/2022, 01/28/2022, and 1/31/2022 while knowingly positive for COVID-19. No documentation exists indicating patient 6 was notified and permission was obtained for HHA K to provide care without proper protective equipment for patient 6. 7. Registered Nurse (RN) C tested positive for COVID-19 on 01/14/2022. Clinical record review for patient 1 and patient 2, who both live together, indicated RN C provided care without a mask for patient 1 on 01/14/2022. The agency failed to indicate if RN C self-screen was done and failed to indicate if patients 1 & 2 were pre-screened prior to the home visit. The agency failed to indicate documentation of patient 1 and patient 2's notification of exposure to COVID-19. 8. The Administrator tested positive for COVID-19 on 01/24/2022. The Administrator provided care for patient 1 on 01/22/2022 and 01/23/2022. The agency failed to indicate documentation of patient 1 and patient 2's notification of exposure to COVID-19. 9. During an interview on 1/31/2022 at 2:40 p.m. asked the Administrator about a COVID-19 log to which he/she indicated, “I don’t have one, we don’t do it. I know who’s been sick. I can produce something if I need to but no, I don’t have a log.” 10. Review of the QAPI binder on 2/1/2022 failed to indicate documentation of the agency surveillance, identification, prevention, control, and investigation, of COVID-19. 11. On 2/1/2022 at 2:10 p.m. the Administrator provided documents the Alternate Administrator had that indicated the following: Infection Control Log: Patient Infections: “Date 8/2021 [patient 3] COVID … Date 12/2021 [patient 2] COVID … Date 1/2022 [patient 8] COVID … Date 1/2022 [patient 6] COVID …" The agency failed to accurately document a specific date for each occurrence of COVID and failed to accurately track, follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control. Infection Control Log: Employee Infections: “Date 1-22 [RN C] COVID … Date 1-22 [Administrator] … Date 1-22 [HHA K] COVID … Date 1-22 [Alternate Administrator] COVID …" All employee COVID infections were documented as community acquired. The agency failed to accurately document a specific date for each occurrence of COVID and failed to accurately track, follow quarantine & isolation guidelines set forth by the CDC and Indiana Code (IC) 410-IAC-1 Disease Reporting & Control.