Every finding on record at Bethany Cares Inc D/B/A

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all Registered Nurses (RNs) followed agency policy specific to frequency of wound measurement for 1 of 1 records reviewed of a patient with an active wound (Registered Nurse #6). Findings include: Review of agency policy #G-270 titled “Wound Measurement” indicated the agency would conduct measurements of wounds weekly. Review of Patient #11’s record (start of care 12/06/2019) included a plan of care for the recertification period 01/19/2023 – 03/19/2023 which indicated the patient was to receive skilled nursing services for 8 hours per day, 4 days per week, for 9 weeks. The plan of care indicated nursing interventions included but were not limited to “evaluate/monitor wounds” and perform wound care to the patient’s Stage 4 pressure ulcer twice a week and as needed. The record indicated RN #6 conducted skilled nurse visits for Patient #11 on 02/06/2023, 02/09/2023, 02/13/2023, 02/14/2023, and 02/15/2023. The record failed to evidence RN #6 measured Patient #11’s wound between 02/04/2023 – 02/16/2023. During an interview conducted on 03/31/2023 at 10:40 AM with the Administrator and Alternate Administrator, the Administrator confirmed Patient #11’s wound was not measured between 02/04/2023 – 02/16/2023. The Administrator reported the nurse measured the patient’s wound on Fridays and had missed the visit on 02/10/2023. During an interview conducted on 03/31/2023 at 11:21 AM with RN #6, the nurse confirmed they provided 40 hours of skilled nursing care for Patient #11 every week. The nurse reported the hospice and Patient #11’s primary caregiver managed the patient’s wound and RN #6 measured the wound once a week. The nurse confirmed Patient #11's wound was not measured between 02/04/2023 - 02/16/2023 due to the nurse missing a visit. 410 IAC 17-12-2(g)

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all Registered Nurses (RNs) followed agency policy specific to frequency of wound measurement for 1 of 1 records reviewed of a patient with an active wound (Patient #11). Findings include: Review of agency policy #G-270 titled “Wound Measurement” indicated the agency would conduct measurements of all wounds weekly. Review of Patient #11’s record included a plan of care for the recertification period 01/19/2023 – 03/19/2023 which indicated the patient was to receive skilled nursing services for 8 hours per day, 4 days per week, for 9 weeks. The plan of care indicated nursing interventions included but were not limited to “evaluate/monitor wounds” and perform wound care to a Stage 4 pressure ulcer twice a week and as needed. The record indicated the agency failed to measure Patient #11’s wound between 02/04/2023 – 02/16/2023. During an interview conducted on 03/31/2023 at 10:40 AM with the Administrator and Alternate Administrator, the Administrator confirmed Patient #11’s wound was not measured between 02/04/2023 – 02/16/2023.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the agency did not provide a home health aide training and competency evaluation program while precluded from offering such programs for 1 of 1 home health agency. Findings include: Review of the employee record for HHA (Home Health Aide) #38 indicated an employee start date of 03/17/2023 and a home health aide registry application dated 03/17/2023, signed by registered nurse [RN] #3 as the nurse who conducted the competency on the same date. The record failed to evidence any home health aide training had begun prior to 03/17/2023. After review of the employee file, the Administrator was unable to provide evidence of any trainings for HHA #38 prior to 03/17/2023 and relayed HHA #38 came in to the agency on 03/09/2023, was interviewed, signed a pre-hire drug screen consent form, and completed a job application and indicated the applicant could not come back in to train at that time, due to a vacation and working another job.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: January 31, February 1, 2, 3, 6, 7. 8. 9; 2023 Unduplicated skilled admissions for past 12 months: 19 Active patients: 80 At this Emergency Preparedness survey, Bethany Cares Home Health Care, was found to not be in compliance with the Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers, including staffing and the implementation of staffing during a pandemic at 42 CFR 484.102. QR: Area 2 02/22/23

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain an emergency preparedness plan which included a facility-based and community-based risk assessment completed biennially, which had the potential to affect all agency patients and employees. Findings include: Agency policy #B-400A titled “Hazard Vulnerability Analysis” (HVA) indicated but was not limited to “… The HVA will be conducted initially when developing the Emergency Preparedness Plan, upon identification of any new external risk factor, when beginning a new service, and annually ….” Review of the agency’s Emergency Preparedness Plan failed to evidence a facility-based and community-based risk assessment was completed since October 2019. During an interview, conducted on 02/09/2023 beginning at 4:10 PM, the Alternate Administrator / Alternate Clinical Manager confirmed the agency had not completed a facility - based and community - based risk assessment since 2019.

This visit was for a Federal Recertification and State Re-licensure survey of a Home Health Provider. Survey Dates: January 31, February 1, 2, 3, 6, 7. 8. 9; 2023 The survey was announced as fully extended on February 3, 2023, at 3:54 PM. Unduplicated skilled admissions for past 12 months: 19 Active patients: 80 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Recertification Survey, Bethany Cares Home Health Agency was found to be out of compliance with Conditions of Participation 484.60 Care planning, coordination of services, and quality of care. Based on the Condition-level deficiencies during the survey completed on 02/09/2023, Bethany Cares Home Health Agency was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on February 3, 2023. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, the agency is precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning February 9. 2023, and continuing through February 8, 2025. QR: Area 2 02/22/23

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to follow its policy of documenting its communication with the responsible physician regarding the need to discharge a patient for noncompliance with the plan of care, the measures the agency took to investigate the patient’s refusal of services, and the interventions the agency attempted in order to obtain patient participation with the plan of care, for 3 of 3 records reviewed of patients who were discharged for noncompliance with the plan of care (Patients #7, 9, 10). 2. Review of Patient #7’s clinical record included a plan of care for certification period 10/23/2022 – 12/21/2022 with orders for HHA (home health aide) services 1 hour per day, 3 days per week for 9 weeks for tasks included but not limited to shower assist, check pressure areas, skin care/ apply lotion, and standby assist. The record evidenced a Discharge Summary dated 11/22/2022 and signed by RN #2 which indicated “Reason for Discharge…Agency/Organization decision Explain: discharged due to non-compliance with home health aide tasks…” The record evidenced a Discharge Order dated 11/22/2022 and signed by RN #2 which indicated “Order Description…Patient discharged from…Home Health Services on 11/22/2022 due to non-compliance of letting aide perform home health aide tasks…” The record failed to evidence RN #2 or administrative staff communicated with Patient #7 or the responsible physician about the possibility of discharge if the patient repeatedly refused personal care. 5. During an interview on 02/07/2023 at 09:36 AM, Patient #7 indicated they were discharged from the agency with approximately 1 day of notice because they take their bath in the evening and indicated the patient was not included in the decision for discharge. Patient #7 also indicated the agency did not offer to provide HHA services at the patient’s preferred bath time in the evening. 6. During an interview on 02/07/2023 at 02:45 PM, the Administrator indicated prior to discharge for non-compliance the agency would try to work with and educate the patient on the risks of non-compliance and notify the physician of non-compliance. Findings include: 1. Agency policy #C-620 indicated but was not limited to “… Discharge Procedure: … 2 … Clients are told in a timely manner of the need to plan for discharge … 3. The physician will be involved in the discharge plan … 9. To avoid charges of ‘abandonment’ at the time of discharge agency documentation will include the following: a. Evidence that the decision was not made unilaterally. The client, family and physician participated in the decision to discharge client from the agency … d. Documentation of all communication with the client … Discharge Criteria: 1. Criteria for discharge may include … c. Client is non-compliant with the established plan of care ….” 3. The clinical record of Patient #9 (start of care 06/29/2022, discharge date 08/23/2022) included a plan of care for the initial certification period of 06/29/2022-08/27/2022, which indicated the patient was to receive home health aide services. The record included a Journal Note, documented by Registered Nurse (RN) #4 on 07/07/2023, which indicated an unnamed home health aide (HHA) reported the patient “never needs any assistance with any personal care.” The note also indicated RN #4 spoke with Patient #9 “about HHA and what it consists of … [RN #4] explained to [patient] that … her aide is there for personal care.” The record included a Journal Note, documented by RN #4 on 08/03/2022, which indicated an unnamed HHA reported Patient #9 called the aide a “housekeeper” and “when [the HHA] tries to talk to [the patient] about her job duties [the patient] does not accept [the aide’s] explanation for … [being] there for [the patient’s] personal care ….” The record failed to evidence the RN #4 nor any other administrative staff spoke with the patient regarding the possibility of discharge if the patient repeatedly refused personal care. The record included a skilled nurse visit for a post-outpatient procedure completed on 07/15/2022 and a HHA supervisory visit completed via telephone on 08/17/2022, both by RN #4. The visit notes failed to evidence the nurse spoke with the patient regarding the possibility of discharge if the patient repeatedly refused personal care. The record included a Journal Note, documented by RN #4 on 08/23/2022 at 8:41 AM, which indicated an unnamed HHA reported Patient #9 was rude, ordered the aide around, and made comments about the aide being a “housekeeper” and “servant.” The record included a second Journal Note, documented by RN #4 on 08/23/2022 at 11:09 AM, which indicated the nurse discussed via email with Patient #9’s case manager the patient’s “behavior issues” and the patient repeatedly refusing personal care. The note indicated the patient’s case manager replied “I [the case manager] was not aware that [Patient #9] was receiving [Medicaid PA] hours and [the patient] has not informed me of having any caregivers in the home … Please discharge [Patient #9] from HHA immediately ….” The record included a third Journal Note, documented by RN #4 on 08/23/2022 at 2:45 PM, which indicated the nurse spoke with Patient #9 “to notify [the patient they] do not meet the criteria for HHA services [due to] no personal care ….” During an interview conducted with RN #4 on 02/09/2023 starting at 2:25 PM, the nurse reported Patient #9 was discharged due to no longer qualifying for home health aide services since the patient had frequently refused personal care during HHA services. The nurse reported while speaking with Patient #9 on 07/07/2023, they did inform Patient #9 that if they continued to refuse personal care then the patient would no longer qualify for home health aide services. RN #4 could not recall any other specific occasions where they informed Patient #9 and/or the patient’s provider of the potential for discharge due to frequent refusal of personal care tasks. 4. The clinical record of Patient #10 (start of care 10/04/2021, discharge date 12/03/2021) included a plan of care for initial certification period 10/04/2021-12/02/2021 which indicated the patient was to receive home health aide services. The record included a HHA supervisory visit completed by RN #4 on 11/17/2021 and recertification comprehensive assessment completed by RN #4 on 12/01/2021. The visit notes failed to evidence RN #4 spoke with Patient #10 regarding the possibility of discharge if the patient repeatedly refused visits and/or personal care tasks. The record included a Journal Note, documented on 12/03/2021 by RN #4, which indicated Patient #10 was discharged from the agency that day due to “multiple missed visits [related to the patient] sending aides away. During HHA hours, [Patient #10] has not been wanting assistance with ADLs, only homemaking tasks ….” During an interview conducted with RN #4 on 02/09/2023 starting at 2:25 PM, the nurse reported Patient #9 was discharged due to no longer qualifying for home health aide services since the patient had multiple missed visits and frequently refused personal care during HHA services. The nurse also reported they did remember speaking with Patient #10 regarding the potential for discharge if the patient continued to repeatedly refuse visits and/or personal care tasks but could not recall exactly when the conversation(s) occurred.

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 notify the patient’s provider, per agency policy, of a change in wound status, abnormal urinary symptoms, and abnormal bowel movement color and consistency (See G590) and failed to ensure staff coordinated care with the patient’s primary caregiver regarding missing a supply of an emergency seizure medication (See G608). The cumulative effect of the noncompliance resulted in the agency being found out of compliance with Condition of Participation 484.60 Care planning, coordination of services, and quality of care.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to notify the patient’s provider according to agency policy of a change in wound status, abnormal urinary symptoms, and abnormal bowel movement color and consistency, for 1 of 1 clinical records reviewed which evidenced a change in patient condition (Patient #4). Findings include: Agency policy #C-360 titled “Coordination of Client Services” indicated but was not limited to “… Special Instructions … 7. The primary care Nurse … will assume responsibility for updating/changing the Care plan and communicating changes to caregivers within twenty-four (24) hours following the conference or changes. The physician will be contacted when his/her approval for that change is necessary and to alert physician to changes in client condition ….” During an interview conducted on 02/08/2023 starting at 12:39 PM with the Administrator/Clinical Manager and Alternate Administrator/Alternate Clinical Manager, the Administrator/Clinical Manager indicated the “primary care nurse” noted in policy C-360 was the patient’s RN Case Manager. The clinical record of Patient #4 included plans of care for the recertification periods 10/19/2022 - 12/17/2022 and 12/18/2022 - 02/15/2023 which indicated patient diagnoses included but were not limited to paraplegia, Type 2 diabetes mellitus, Stage 4 pressure ulcer (type of wound caused by prolonged pressure on an area of the body, classified as stages between 1 through 4 based on wound severity, with Stage 4 the worst) of right buttock, Stage 3 pressure ulcer of right ankle, and Stage 4 pressure ulcer of left buttock. The plans of care included orders for skilled nursing visits to be conducted 3 hours per day, 2 days a week for 9 weeks, with nursing interventions which included but were not limited to “evaluate for [signs and symptoms] of infections … evaluate/monitor wounds/healing … Complete weekly wound measurements ….” The plans of care were signed by Patient #4’s primary care provider (PCP) and indicated the patient’s wounds were “assessed and treated” by a local wound clinic. The plan of care for the recertification period 10/19/2022 - 12/17/2022 indicated the patient was tested for C.diff (a bacterial infection of the intestines which results in severe diarrhea and inflammation of the colon) and the test was negative. The record included a recertification comprehensive assessment completed on 10/14/2022 by RN #2. The assessment note indicated the patient had two wounds – one Stage 4 to the right hip and one Stage 4 to the left sacrum/gluteal cleft. The record included a skilled nurse visit conducted on 10/22/2022 by RN #1. The visit note indicated the patient’s wound to the left sacrum/gluteal cleft increased by 1 centimeter (cm) in length. The record failed to evidence the patient’s wound clinic was notified of the increase in wound size. The record included a skilled nurse visit conducted on 11/11/2022 by RN #1. The visit note indicated the patient’s wound to the right hip increased by 1.5 cm in width and 2 cm in depth and indicated the patient’s urine was cloudy with sediment noted. The record failed to evidence the patient’s wound clinic was notified of the increase in wound size nor was the PCP notified of the abnormal urine symptoms. The record included a skilled nurse visit was conducted on 11/18/2022 by RN #1. The visit note indicated the patient’s wound to the right hip increased by 1 cm in length and 1 cm in width and the wound to the left sacrum/gluteal cleft had increased by 1.5 cm in width and had “deteriorated.” The note indicated a large amount of sediment was in the patient’s urine. The record failed to evidence the patient’s wound clinic was notified of the increases in wound size nor was the PCP notified of the abnormal urinary symptom. The record included a skilled nurse visit conducted on 11/21/2022 by RN #1. The nurse visit note indicated a new Stage 2 pressure ulcer to the left hip was observed and noted the patient’s wound clinic had not seen the patient since the development of the wound and indicated the patient’s urine was cloudy and had a large amount of sediment which had clogged the patient’s urinary catheter and required a change in catheter systems. The record failed to evidence the patient’s wound clinic was notified of the newly developed wound nor were wound care orders were obtained. The record included a skilled nurse visit conducted on 11/25/2022 by RN #1. The visit note indicated the wound to Patient #4’s left hip had deteriorated to a Stage III pressure ulcer and had developed slough in the wound bed, the right hip wound had increased by 1 cm in width, and the wound to the left sacrum/gluteal cleft had increased in size by 2 cm in length and had “deteriorated.” The note also indicated the patient reported abdominal pain, their urine had sediment in it, and the patient’s stool had a mucus-like consistency and was blood tinged. The record failed to evidence the patient’s wound clinic was notified of the increases in wound size nor was the PCP notified of the patient’s abnormal urinary symptoms and bowel movement. The record included a skilled nurse visit conducted on 12/05/2022 by RN #1. The visit note indicated the wound to Patient #4’s right hip had increased by 2 cm in width and 1.5 cm in depth and the wound to the left hip had increased by 1 cm in width. The note also indicated the patient’s urine was amber colored and had sediment. The record failed to evidence the patient’s wound clinic was notified of the increases in wound size nor was the PCP notified of the patient’s abnormal urinary symptoms. The record included a skilled nurse visit conducted on 12/09/2023 by RN #1. The visit note indicated the patient had sediment in their urine. The visit note failed to evidence the PCP was notified of the patient’s abnormal urinary symptom. The record included a skilled nurse visit conducted on 12/12/2023 by RN #1. The visit note indicated the patient had sediment in their urine. The visit note failed to evidence the PCP was notified of the patient’s abnormal urinary symptom. The record included a recertification comprehensive assessment completed on 12/13/2022 by RN #2. The assessment note indicated the patient had 3 wounds – one Stage 4 to the right hip, one Stage 4 to the left sacrum/gluteal cleft, and one Stage 3 to the left hip. The record included a skilled nurse visit was conducted on 12/30/2022 by RN #1. The visit note indicated the wound to the left sacrum/gluteal cleft had increased by 1 cm in length and indicated the patient’s urine was amber colored, had an odor, and sediment was noted. The record failed to evidence the patient’s wound clinic was notified of the increase in wound size nor was the PCP notified of the patient’s abnormal urinary symptoms. The record included a skilled nurse visit was conducted on 01/03/2023 by RN #1. The visit note indicated the patient had a large amount of sediment in their urine which was blocking their catheter and required a change in catheter systems. The record failed to evidence the patient’s PCP was notified of the patient’s abnormal urinary symptoms. The record included a skilled nurse visit was conducted on 01/06/2023 by RN #1. The visit note indicated the wound to the left hip had increased by 1 cm in length and 1 cm in depth. The record failed to evidence the patient’s wound clinic was notified of the increase in wound size. The record included a skilled nurse visit conducted on 01/13/2023 by RN #1. The visit note indicated the wound to the left hip had increased by 1 cm in length and the wound to the left sacrum/gluteal cleft had increased by 2 cm in width and extended to the patient’s right coccyx and gluteal cleft. The record failed to evidence the patient’s wound clinic was notified of the increases in wound size. The record included a skilled nurse visit conducted on 01/30/2023 by RN #1. The visit note indicated two new wounds were observed –one Stage 2 pressure ulcer to the right heel and one Stage 2 pressure ulcer to the right ankle. The record failed to evidence the patient’s wound clinic was notified of the newly developed wounds nor were wound care orders obtained until the next skilled nurse visit on 02/03/2023. An interview was conducted on 02/06/2023 starting at 3:40 PM with the Administrator/Clinical Manager and Alternate Administrator/Alternate Clinical Manager. During the interview, the Administrator/Clinical Manager reported the RN case manager was responsible for coordinating all care for the patient. The Administrator/Clinical Manager confirmed the RN case manager should notify the treating provider of a newly developed wound and if the patient was exhibiting signs or symptoms of infection. An interview was conducted on 02/07/2023 beginning at 4:02 PM with RN #2, who was Patient #4’s RN Case Manager. During the interview, the nurse reported Patient #4’s wound clinic did not have any protocols for when the home health agency was to notify the clinic of changes in the patient’s wounds. The nurse stated they would notify Patient #4’s wound clinic for changes which would indicate an infection such as change in wound bed color, wound drainage which was more viscous, and/or wound odor. 17-13-1(a)(2)

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure staff coordinated care with the patient’s primary caregiver regarding missing a supply of an emergency seizure medication for 1 of 1 nurse visit observations with a patient with emergency seizure medications (Patient #2). Findings include: The clinical record of Patient #2 included a plan of care for the recertification period 01/02/2023 - 03/02/2023 which indicated the patient’s diagnoses included but were not limited to cerebral palsy and epilepsy. The plan of care indicated the patient’s current medications included but were not limited to Diazepam (Diastat, given to treat seizures) 10 milligram rectal kit to be given as needed for seizures lasting more than 5 minutes. The record included a “Seizure Management Plan,” reviewed and signed by Registered Nurse (RN) #4, the patient’s RN case manager, on 01/01/2023. The patient’s seizure management plan indicated seizure interventions included, but were not limited to, administer the as needed Diastat medication for seizures lasting longer than 5 minutes. A visit observation was conducted with Patient #2 and Licensed Practical Nurse (LPN) #1 starting at 11:16 AM outside of the patient’s home. During the visit LPN reported the patient’s supply of emergency Diastat was typically kept in the patient’s backpack, however they did not currently have a supply of the medication. LPN #1 reported they had not discussed the missing medication with the patient’s primary caregiver. The nurse estimated the medication had been missing from their backpack for approximately 1 week. An interview was conducted on 02/02/2023 starting at 3:36 PM with Patient #2’s primary caregiver. During the interview the primary caregiver reported LPN #1 was responsible for preparing the patient’s backpack and the caregiver was not aware the Diastat was missing from the patient’s backpack. An interview was conducted on 02/02/2023 starting at 3:55 PM with the Alternate Administrator/Alternate Clinical Manager. During the interview, the Alternate Administrator/Alternate Clinical Manager confirmed the nurse should ensure all patient emergency medications were available at all times and should coordinate with the patient’s and/or caregiver if the medication(s) was/were not available. 17-12-2(g)

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 home health agency failed to ensure all staff followed standard precautions and infection control policies and procedures for 3 of 3 home visit observations (Licensed Practical Nurse (LPN) #1, Registered Nurse (RN) #2, Home Health Aide (HHA) #3). Findings include: 1. Agency policy titled “Hand Washing” indicated but was not limited to “… The Center for Disease Control (CDC) recommends routinely washing hands in the following situations: … After caring for a client … Procedure … 11. Wash hands, using plenty of lather and friction for at least 30 seconds ….” 2. Agency in-service document titled “Bag Technique In-Service” indicated but was not limited to “… The CDC recommends that each home care agency implement policies that define that the equipment of the nursing bag be cleaned on a ‘regular’ basis … ‘regular’ basis to mean ‘after each use on a patient and before replacing the item in the nursing bag’ ….” 3. A home visit observation was conducted on 02/01/2023 beginning at 11:16 AM with Patient #2 (start of care 09/14/2020) and LPN #1. During the visit, the nurse was observed cleaning the patient’s gluteal cleft (groove between the buttocks) by wiping from the patient’s lower back towards the vagina. After completing perineal care, LPN #2 removed their gloves but failed to perform hand hygiene prior to completing further patient care. 4. A home visit observation was conducted on 02/02/2023 beginning at 10:00 AM with Patient #3 (start of care 06/24/2019) and RN #2. During the visit, the nurse was observed and failed to perform hand hygiene in between glove changes. RN #2 was observed removing a clipboard from their nursing bag, placed the clipboard on the patient’s table and wrote notes, then returned the clipboard to their nursing bag, and failed to clean the clipboard prior to returning it to the bag. 5. A home visit observation was conducted on 02/03/2023 beginning at 10:15 AM with Patient #6 (start of care 08/24/2021) and HHA #3. During the home visit, the aide was observed failing to perform hand hygiene in between glove changes on 2 occasions and was observed and to wash their hands for 17 seconds. 6. An interview was conducted on 02/03/2023 beginning at 3:47 PM with the Alternate Administrator/Alternate Clinical Manager. During the interview, the Alternate Administrator/Alternate Clinical Manager confirmed staff should wash their hands for a minimum of 30 seconds, staff should perform hand hygiene in between glove changes, and staff should not place dirty equipment into their nursing bag. The Alternate Administrator stated when performing perineal care on female patients, staff should clean the patient from the front of the gluteal cleft (closest to the vagina) to the back of the cleft (closest to the spine). 17-12-1(m)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the aide care plan was detailed and specific to the individual patient for 4 of 4 records reviewed of patients receiving home health aide services (Patients #1, 3, 4 and 6). 3. Review of Patient #3’s clinical record included a Plan of Care for the recertification period 12/05/2022 – 02/02/2023 which indicated the patient was to receive HHA services for 7 hours per day, 5 days per week for 9 weeks. The record also included an aide care plan which indicated aide tasks included “check pressure areas … clean under fingernails … clear pathways … dressing/clothing assist … file fingernails … incontinent urine assist … make bed and straighten client area … meal prep … mobility assist … peri care … re-positioning bed/chair … shower assist 1x [one time] weekly … Skin care/apply lotion 1x weekly … toileting assist … transfer assist … wheelchair assist.” The aide care plan failed to evidence the frequency all tasks, except showering and skin care, were to be completed. The aide visit notes for Patient #3 were reviewed and indicated the patient either declined or was “noncompliant” with the tasks clean under fingernails, file fingernails, and showering during all aide visits for the certification period 12/05/2022 – 02/02/2023. An interview was conducted with RN #3, RN Case Manager for Patient #3, on 02/08/2023 starting at 3:15 PM. During the interview, the nurse reported they did not regularly review aide visit notes unless there was a “concern” and was unaware Patient #3 was refusing or “noncompliant” with showering and nail care related tasks. The nurse also reported they did not review specific tasks with the patient and/or aide during recertification or supervisory visits to ensure the tasks were still needed and/or appropriate for the patient. 4. Review of Patient #4’s clinical record included a Plan of Care for the recertification period 12/18/2022-02/15/2023 which indicated the patient was to receive HHA services for 5 hours per day, 7 days per week for 9 weeks. The record also included an aide care plan which indicated the aide tasks included “bed bath assist … catheter care … check pressure areas … dressing/clothing assist … hair care … incontinent bowel assist [inability to control bowel movements] … incontinent urine assist … make bed and straighten client area … medication reminders … mobility assist … re-positioning bed/chair … skin care/apply lotion … transfer assist … wheelchair assist.” The aide care plan failed to evidence the frequency the above tasks were to be completed. 5. Review of Patient #6’s clinical record included a Plan of Care for the recertification period 12/17/2022-02/14/2023 which indicated the patient was to receive HHA services for 1 hour per day, 7 days per week for 9 weeks. The record also included an aide care plan which indicated the aide tasks included “ambulation assist … brush teeth/oral care … check pressure areas … clean client area … clear pathways … document seizure frequency and duration … dressing/clothing assist … incontinent urine [inability to control urination] assist … make bed and straighten client area … mobility assist … nail care … peri care [perineal, cleaning of genital and buttocks areas] … shaving (no blood thinners) … shower assist … skin care/apply lotion … standby assist … transfer assist.” The aide care plan failed to evidence the frequency all tasks were to be completed. Findings include: 1. Policy C-751 “Home Health Aide Care Plan” indicated “… A complete and appropriate Care Plan, identifying duties to be performed by the Home Health Aide, shall be developed by a Registered Nurse… Purpose… To provide a means of assigning duties to the Home Health Aide that are clear to the… Home Health Aide…The Care Plan shall be developed in plain, non-technical lay terms, and identify the duties to be performed… The Home Health Aide Care Plan shall be reviewed and updated by the Registered Nurse minimally every 60 days…” 2. Review of Patient #1’s clinical record evidenced a Plan of Care for certification period 01/17/2023 – 03/17/2023 which indicated diagnoses including multiple sclerosis (a disease in which the immune system eats away at the protective covering of the nerves) and type 2 diabetes mellitus without complications (a chronic condition that affects the way the body processes blood sugar) and included orders for HHA (home health aide) services for 6 hours per day, 5 days per week for 9 weeks. The record also included an aide care plan which included the following tasks: blood sugar reminders, check pressure areas, clean client area, clear pathways, dressing/ clothing assist, hair care, incontinent bowel assist, incontinent urine assist, make bed and straighten client area, meal prep, medication reminders, mobility assist, nail care, pericare, re-positioning bed/ chair, shower assist, skin care/ apply lotion, stand by assist, toileting assist, transfer assist, and did you wear a face mask during your shift. The record indicated the HHA services are scheduled in 2-hour shifts, three times per day, 5 days per week. The aide care plan failed to include a frequency for each task, failed to specify which tasks were to be performed on each of the 3 shifts, and failed to specify not to cut nails under nail care for this diabetic patient. 6. During an interview on 02/07/2023 at 02:45 PM, the Administrator indicated they had just noticed the previous day that the EMR software had added the option to include frequency on the aide care plan and admitted could have put “shower in AM,” etc., to clarify when to have performed a task on the aide care plan. The Administrator also indicated the aide care plan for a diabetic patient should have said no clipping of the nails under nail care.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aide completed appropriate documentation of care in compliance with the home health agency’s policies and procedures for 1 of 4 active patients who received home health aide services (Patient #1.) Findings include: 1. Review of Policy C-140 “Position: Home Health Aide” indicated “…Completes the appropriate records to document care given…” 2. Review of Policy C-220 “Home Health Aide Service” indicated “…Home health aides must document each visit at the time care is provided…All services provided by the Home Health Aide shall be documented in the clinical record…” 3. Review of C-800 “Home Health Aide: Documentation” indicated “…Home health aides will document care/ services provided on the home health aide charting form…” 4. Review of Patient #1’s clinical record evidenced a Plan of Care for certification period 01/17/2023 – 03/17/2023 which indicated diagnoses including multiple sclerosis (a disease in which the immune system eats away at the protective covering of the nerves) and type 2 diabetes mellitus without complications (a chronic condition that affects the way the body processes blood sugar) and included orders for HHA (home health aide) services for 6 hours per day, 5 days per week for 9 weeks. The record included an aide care plan which included the following tasks: blood sugar reminders, check pressure areas, clean client area, clear pathways, dressing/ clothing assist, hair care, incontinent bowel assist, incontinent urine assist, make bed and straighten client area, meal prep, medication reminders, mobility assist, nail care, pericare, re-positioning bed/ chair, shower assist, skin care/ apply lotion, stand by assist, toileting assist, transfer assist, and did you wear a face mask during your shift. The record indicated the HHA services are scheduled in 2-hour shifts, three times per day, 5 days per week. The record evidenced HHA #1 marked every task on the aide care plan as completed all 3 shifts on 01/18/2023, 01/19/2023, 01/20/2023, 01/23/2023, 01/24/2023, 01/25/2023, 01/26/2023, 01/27/2023, 01/30/2023, 01/31/2023, 02/01/2023, 02/02/2023, and 02/03/2023. 5. During an interview on 02/02/2023 at 01:39 PM, Patient #1 indicated they normally took a shower during the afternoon shift once per week and indicated they had not taken a shower on 02/01/2023 and had not had plans to shower on 02/02/2023 because of pain. Patient #1 indicated they had not received nail care but had recently purchased an emery board. 6. During an interview on 02/03/2023 at 03:34 PM, HHA #1 indicated they documented their visits and check off the tasks completed in the agency’s app and indicated if the patient declined the task, they checked the declination and have a list of reasons to choose. When asked whether they did every task on the task list during each shift for Patient #1, HHA #1 indicated they tried, indicated Patient #1 usually had 1-2 showers per week and that he / she marked a task as completed on each shift if the task was completed at any time during that day. HHA #1 confirmed they had not yet assisted Patient #1 with a shower during any shift on 01/31/2023, 02/01/2023, 02/02/2023, nor on 02/03/2023. HHA #1 indicated they did not touch Patient #1’s toenails because the patient was a diabetic though had filed and sometimes painted Patient #1’s fingernails if Patient requested. 7. During an interview on 02/07/2023 at 02:45 PM, the Administrator indicated the HHA should not have marked each task as completed every shift of the day if the task was only completed on one shift of the day and indicated the HHA should document tasks as completed that were not completed.

This was a federal and state complaint survey to investigate 2 (two) complaints. Complaint # IN00357184; Substantiated with findings Complaint # IN00323163; Substantiated with findings Survey dates: July 26, 27, 28, 29; 2021 Facility number: 012408 Provider number: 15K060 Total census: 292 Skilled patients: 21 Total records reviewed: 7 Quality Review Area 2

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 record review and interview, the agency failed to ensure patients had the right to receive services outlined in the plan of care if they had a bed bug infestation. This had the potential to affect all patients. Findings Include: An undated policy titled "Admission Policy," stated, " ...All services are available without distinction to all program participants, regardless of diagnosis ...." A document titled "Pest and Rodent Policy," within the agency's admission packet, stated "It is Bethany Cares Inc. policy that when informed of a client having pest/rodents they may be placed on hold until we receive documentation from Licensed Exterminator that the home has been inspected and cleared of pests/rodents ... Once the issue has been resolved and the home has been treated, we may resume services ... The agency requires a letter from the Exterminator/or [sic] Management Company that the property is cleared of pests/rodents ...." During an interview on 7/29/21 at 2:30 PM, when asked if all needs of all patients accepted to the agency's care needed to always be met, the Administrator stated "Yes." 17-13-1(a)

Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure confidentiality of clinical records. Findings include: 1. An undated document titled "Clinical Record Confidentiality," stated " ...Special Instructions ... All individuals who collect, handle, or disseminate information will be informed of their responsibility to protect data ...." 2. An undated document titled "Patient Home Health Rights & Responsibilities," stated " ...Copy of the HHA [Home Health Agency] Patient Rights & Responsibilities Document ... As a patient of Bethany Cares Home Health Agency you have the following rights ... Have a confidential clinical record ...." 3. An agency complaint reviewed from the complaint log dated 8/20/20 regarding patient #4 indicated "...Client/Family Concern ... Staff from therapy facility stated pt [sic] arrived via car ... unaware of surroundings ... B/P [blood pressure] up ... low blood sugar ... called unit ... transported to ER [sic] ... Also stated Aide [Home Health Aide C] called office to change appts [sic] to suit her schedule to allow her to bring him to appts [sic] ... Also stated [Home Health Aide C] had her husband and son come to the office to pick up [Patient #4]'s car and they refused to let him leave with car and keys ... Stated husband and son became angry and then did leave ... Employee Comments ... [Home Health Aide C] called ... asked if she called Therapy office to change his appts [sic] ... she said absolutely not ... only changes appts [sic] if [Patient #4] asks her to ... asked if she sent her son and husband to get car ... she said yes therapy called her asked her for his son's info and stated his car was here ... so her husband and son went to go get it and they refused ... I [Alternate Administrator] stated that no one should be picking up his car ... no one should know anything about your patients ... your husband and son do not have any reason to go pick up his car ... HIPPA [sic] ... employee received training counseling ... V/U [voiced understanding] ... Results of Investigation ... Employee V/U [voiced understanding] of following HIPPA [sic] ... employee educated to notify office of any change in conditions ... RNCM [Registered Nurse Case Manager] must call to change appts [sic] ... RN [Registered Nurse] can call son's [sic] to pick up car ... All patient info [sic] is not to be discussed outside of BCHHA [Bethany Cares Home Health Agency] ... Aide V/U [sic] ... Corrective Action ... Employee counseling completed ... Aide removed from [Patient #4] home ... RNCM followed up with patient/MD [Medical Doctor]/family ...." 3. During an interview on 7/29/21 at 10:30 AM, when asked if having a staff member's husband pick up a patient's car was a violation of their confidentiality, the Alternate Administrator stated, "Yes." 17-12-3(b)(2)(E)

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency's Registered Nurse (RN) failed to ensure the comprehensive assessment contained an accurate assessment of the patient's functional status for 1 of 2 records with home visits (#1). Findings Include: 1. A policy dated 1/1/20, titled "Client Reassessment/Update of Comprehensive Assessment," stated " ....The Registered Nurse is responsible for reassessing the need for Home Health Aide services ... The initial and ongoing assessments include consideration of the following ... need for continuing home care services ...." 2. The clinical record of patient #1 was reviewed on 7/27/21 at 1:01 PM and indicated a start of care date of 4/5/2021. The record contained a plan of care for the certification dates 6/4/21 to 8/2/21, that indicated diagnoses of, but not limited to, unspecified intellectual disabilities (broad category of disorders characterized by an impairment to the intelligence an individual possesses), morbid obesity due to excess calories), essential primary hypertension (a form of hypertension that by definition has no identifiable secondary cause), and unspecified asthma (lung disorder characterized by narrowing of the airways, the tubes which carry air into the lungs, that are inflamed and constricted, causing shortness of breath, wheezing and cough). During a home visit on 7/28/21 at 11:30 AM with patient #1, the patient was observed to ambulate with no assistance and can provide own care when asked to complete a task. The patient was observed to need verbal cues only. A recertification comprehensive assessment dated 6/1/21, completed by Registered Nurse D, the section titled ADL/IADLs (activities of daily living/instrumental activities of daily living was found to be blank. The section titled "Goal/Intervention Summary," stated " ...Pt [patient] continues to require assistance with ADLs ...." No description of the assistance needed by the patient was recorded. 3. During an interview on 7/28/21 at 11:30 AM, when asked who provided care for Patient #1 when the agency did not staff on the weekends, Patient #1's Mother stated "She does her own care when no one comes." 4. During an interview on 7/29/21 at 2:30 PM, when asked if the functional status of the patient had improved, should the comprehensive assessment be updated to reflect that, the Administrator stated "Yes." 17-14-1(a)(1)(B)

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure comprehensive assessments contained strengths identified by the patient for 3 of 4 active skilled nursing patient records reviewed (#1, 2, 5). Findings Include: 1. A policy dated 1/1/20, titled "Client Reassessment/Update of Comprehensive Assessment," stated " ....The initial and ongoing assessments include consideration of the following ... description of any applicable strength the client has including physical, psychosocial, and or [sic] spiritual resources that increase their ability to respond effectively to treatment and the ability to learn ...." 2. The clinical record of patient #1 was reviewed on 7/27/21 at 1:01 PM and indicated a start of care date of 4/5/2021. The record contained a plan of care for the certification dates 6/4/21 to 8/2/21, that indicated diagnoses of, but not limited to, unspecified intellectual disabilities (broad category of disorders characterized by an impairment to the intelligence an individual possesses), morbid obesity due to excess calories, essential primary hypertension (a form of hypertension that by definition has no identifiable secondary cause), and unspecified asthma (lung disorder characterized by narrowing of the airways, the tubes which carry air into the lungs, that are inflamed and constricted, causing shortness of breath, wheezing and cough). A recertification comprehensive assessment dated 6/1/21, completed by Registered Nurse D, failed to evidence patient strengths. 3. The clinical record of patient #2 was reviewed on 7/29/21 at 10:00 AM and indicated a start of care date of 6/7/19. The record contained a plan of care for the certification dates of 7/26/21 to 9/23/21, that indicated diagnoses of, but not limited to, history of pulmonary embolism (one of the pulmonary arteries in the lungs gets blocked by a blood clot), spondylosis (age-related condition where the joints and cartilage lined discs of the neck are affected), fibromyalgia (disorder that affects muscle and soft tissue characterized by chronic muscle pain, tenderness, fatigue and sleep disturbances), and major depressive disorder (mental health disorder having episodes of psychological depression). A recertification comprehensive assessment dated 7/21/21, completed by Registered Nurse E, failed to evidence patient strengths. 4. The clinical record of patient #5 was reviewed on 7/29/21 at 10:30 AM and indicated a start of care date of 12/6/19. The record contained a plan of care for the certification dates of 5/29/21 to 7/27/21, that indicated diagnoses of, but not limited to, Duchenne or Becker muscular dystrophy (inherited disorder that involves slowly worsening muscle weakness of the legs and pelvis), chronic respiratory failure with hypercapnia (inadequate gas exchange by the respiratory system, meaning that the arterial oxygen, carbon dioxide or both cannot be kept at normal levels), tracheostomy status ((an incision in the windpipe made to relieve an obstruction to breathing), gastronomy status (tube inserted through the belly that brings nutrition directly to the stomach), and ileostomy status (a piece of the ileum is diverted to an artificial opening in the abdominal to wall to allow passage of stool). A resumption of care comprehensive assessment dated 5/28/21, completed by Registered Nurse F, failed to evidence patient strengths. 5. During an interview on 7/29/21 at 2:30 PM, when asked if the comprehensive assessment should contain patient strengths, the Administrator stated "There are no areas on Kantime to do that."

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review, the agency failed ensure comprehensive assessments contained the patient's primary caregiver's availability, willingness, and schedule they're able to provide care for 3 of 4 active skilled nursing patient records reviewed (#1, 2, 5). Findings Include: 1. A policy dated 1/1/20, titled "Client Reassessment/Update of Comprehensive Assessment," stated " ....The initial and ongoing assessments include consideration of the following ... Special Instruction ... client needs and the availability of family will be considered ...." 2. The clinical record of patient #1 was reviewed on 7/27/21 at 1:01 PM and indicated a start of care date of 4/5/2021. The record contained a plan of care for the certification dates 6/4/21 to 8/2/21, that indicated diagnoses of, but not limited to, unspecified intellectual disabilities (broad category of disorders characterized by an impairment to the intelligence an individual possesses), morbid obesity due to excess calories, essential primary hypertension (a form of hypertension that by definition has no identifiable secondary cause), and unspecified asthma (lung disorder characterized by narrowing of the airways, the tubes which carry air into the lungs, that are inflamed and constricted, causing shortness of breath, wheezing and cough). A recertification comprehensive assessment dated 6/1/21, completed by Registered Nurse D, failed to evidence the patient's primary caregiver's schedule of availability to provide care. 3. The clinical record of patient #2 was reviewed on 7/29/21 at 10:00 AM and indicated a start of care date of 6/7/19. The record contained a plan of care for the certification dates of 7/26/21 to 9/23/21, that indicated diagnoses of, but not limited to, history of pulmonary embolism (one of the pulmonary arteries in the lungs gets blocked by a blood clot), spondylosis (age-related condition where the joints and cartilage lined discs of the neck are affected), fibromyalgia (disorder that affects muscle and soft tissue characterized by chronic muscle pain, tenderness, fatigue and sleep disturbances), and major depressive disorder (mental health disorder having episodes of psychological depression). A recertification comprehensive assessment dated 7/21/21, completed by Registered Nurse E, failed to evidence the patient's primary caregiver's schedule of availability to provide care. 4. The clinical record of patient #5 was reviewed on 7/29/21 at 10:30 AM and indicated a start of care date of 12/6/19. The record contained a plan of care for the certification dates of 5/29/21 to 7/27/21, that indicated diagnoses of, but not limited to, Duchenne or Becker muscular dystrophy (inherited disorder that involves slowly worsening muscle weakness of the legs and pelvis), chronic respiratory failure with hypercapnia (inadequate gas exchange by the respiratory system, meaning that the arterial oxygen, carbon dioxide or both cannot be kept at normal levels), tracheostomy status ((an incision in the windpipe made to relieve an obstruction to breathing), gastronomy status (tube inserted through the belly that brings nutrition directly to the stomach), and ileostomy status (a piece of the ileum is diverted to an artificial opening in the abdominal to wall to allow passage of stool). A resumption of care comprehensive assessment dated 5/28/21, completed by Registered Nurse F, failed to evidence the patient's primary caregiver's schedule of availability to provide care. 5. During an interview on 7/29/21 at 2:30 PM, when asked if the comprehensive assessment should include the client primary caregiver's schedule of availability, the Administrator stated "Yes."

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 accurate and complete information was on the plan of care for 1 of 4 active skilled nursing records reviewed (#5). Findings Include: An undated policy titled "Care Plans," stated " ...The Care Plan shall include, but not be limited to ... a list of specific interventions with plans for implementation ...." The clinical record of patient #5 was reviewed on 7/29/21 at 10:30 AM and indicated a start of care date of 12/6/19. The record contained a plan of care for the certification dates of 5/29/21 to 7/27/21, that indicated diagnoses of, but not limited to, Duchenne or Becker muscular dystrophy (inherited disorder that involves slowly worsening muscle weakness of the legs and pelvis), chronic respiratory failure with hypercapnia (inadequate gas exchange by the respiratory system, meaning that the arterial oxygen, carbon dioxide or both cannot be kept at normal levels), tracheostomy status (an incision in the windpipe made to relieve an obstruction to breathing), gastronomy status (tube inserted through the belly that brings nutrition directly to the stomach), and ileostomy status (a piece of the ileum is diverted to an artificial opening in the abdominal to wall to allow passage of stool). The plan of care failed to provide evidence of information necessary to operate the patient's ventilator (such as settings, emergency management and trouble shooting). During an interview on 7/29/21 at 2:30 PM, when asked if a patient uses a ventilator, do the settings for that need to be included on the plan of care, the Administrator stated "The settings were on comprehensive assessment, but not on the care plan. We are fixing that." 17-13-1(a)(1)(D)(ix)

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 infection control precautions were maintained for 2 of 2 patients with home visit observations (#1, 3). Findings Include: 1. An undated policy titled "Hand Washing," stated, " ...The Center for Disease Control recommends routinely washing hands in the following situations ... before contact with patients ... after handling contaminated equipment ... Procedure ... wash hands ... for at least 30 seconds ...." An undated policy titled "Bag Technique," stated, " ...Bag placement in the home ... place a barrier under the bag or hang it on a doorknob or the back of a heavy chair ...." 2. During a home visit 7/27/21 at 11:30 AM with patient #1 (start of care 4/5/21), Home Health Aide G was observed donning gloves without first completing hand hygiene (hand sanitizer or handwashing). 3. During a home visit on 7/28/21 at 11:00 AM with patient #3 (start of care 10/3/17), Registered Nurse H was observed washing her hands for 8 seconds before donning gloves and setting nursing supply bag on the patient's home floor with no barrier in place. 3. During an interview on 7/29/21 at 2:30 PM, when asked if all staff needed to use hand sanitizer or wash their hands before donning gloves for patient care, the Administrator stated "Yes." When asked how long staff needed to wash their hands before donning gloves for patient care, the Administrator stated "30 [thirty] seconds." When asked if it was appropriate for a staff member to set their nursing bag on the floor, in a patient home, the Administrator stated "No." 17-12-1(m)

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 observation, record review, and interview, the agency failed to ensure COVID infection control precautions were followed for 2 of 2 patient home visit observations (#1, 3). Findings Include: 1. A policy dated 3/16/2020, titled "COVID-19 Patient Care Policy for All Field Staff," stated " ....Pre-visit screening process ... All patients are called via the phone to perform a COVID-19 screening process on the days of scheduled home visits ...." 2. The clinical record of patient #1 was reviewed on 7/27/21 at 1:01 PM and indicated a start of care date of 4/5/2021. The record contained a plan of care for the certification dates 6/4/21 to 8/2/21. During a home visit on 7/27/21 at 11:30 AM with patient #1, Home Health Aide G was observed screening patient for COVID symptoms after already having physical contact with the patient. 3. The clinical record of patient #3 was reviewed on 7/28/21 at 11:00 AM and indicated a start of care date of 10/3/17. The record contained a plan of care for the certification dates of 7/14/21 to 9/11/21. During a home visit on 7/29/21 at 11:00 AM with patient #3, Registered Nurse H was observed screening patient for COVID symptoms after already having physical contact with the patient. 3. During an interview on 7/29/21 at 2:30 PM, when asked if all staff needed to screen patients for COVID before having physical contact with them, the Administrator stated "Yes."