Every finding on record at Olidia Care Inc

On 4/10/23 to 4/20/23 a complaint survey was conducted. This resulted in a partial extended survey at Olidia Care. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. H81541383C/97403 and H81549866C/97075 was unsubstantiated. H81541143C/97206, H81541420C/97405, H81541068C/97216 was substantiated deficiencies were issued at G940, G950, and G960 as a result of the complaint investigation. An Immediate Jeopardy (IJ) began on 4/12/23 when the administrator and/or clinical manager failed to have oversight of patient and personnel assignments, and respond to nurse phone calls and/or text messages during hours of operation. Nursing staff were working up to and more than 24 continuous hours fatigued and exhausted risking the health and safety of patients who were dependent on nursing care and services for patients at risk for respiratory failure due to tracheostomy and ventilator dependence, and quadriplegic. The Director of Home Health Care and the Clinical Manager were notified of the IJ on 4/13/23 at 3:19 p.m. The immediate jeopardy was not removed at the time of exit on 4/20/23. The Condition of Participation: Organization and Administration of Services 42 CFR 484.105 at G940 was found not met.

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 observation, interview, and document review, the agency failed to ensure 3 of 3 patients (P1, P2, and P5) reviewed were offered to participate in the plan of care (POC) following the 60-day assessments performed by agency registered nurses. During an observation on 4/14/23 at 3:09 p.m. the director of nursing (DON) was giving P1 a bed bath and P1 asked the DON for a copy of his care plan, so he knows which days he is to be getting his baths. P1 asked the DON about wound care, tracheostomy care orders, a medication list, and to be part of the care planning process on his next assessment. The DON responded that she would make sure he has lists and will be part of his POC planning moving forward. P1's plan of care (POC) dated 1/30/23 – 3/31/23, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, and neurogenic bladder P1 had a gastrostomy tube (G-tube), indwelling foley catheter, and a tracheostomy. Under the title Safety measures, P1 required fall, seizure, respiratory, and obstructed tracheostomy precautions. P1 was incontinent of bowel. Staff was to change his incontinent brief and reposition him in bed every two hours. P1 had a sacral wound with daily orders for dressing change, a right lower leg wound with wound care orders for three times a week, a coccyx wound with orders cleanse after each bowel movement, a heel wound with three times a week orders. Skilled nurse may provide range of motion exercises to client. Skilled nurse was to assess respiratory status each shift and perform oxygen saturation (SP02) throughout the shifts, in addition suction tracheostomy every 3 hours as needed. P1 required total assistance with activities of daily living (ADL’s), P1 required tracheostomy and G-tube care twice daily. The POC further indicated complex registered nurse (RN), licensed practical nurse (LPN) or private duty nursing (PDN) services 16-24 hours 4-7 days a week. The POC did not indicate a frequency for range-of-motion exercise, how P1 was supposed to bath and how he transferred out of bed to his wheelchair. P2's POC dated 1/26/23 – 3/27/23, indicated P2 was diagnosed with acute respiratory failure, cardiovascular accident, and mitral valve replacement. Under the title Safety Measures P2 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P2 was incontinent of bowel and bladder, he required staff to reposition him every one-two hour. Nursing was to monitor and manage P2’s blood glucose levels. Nursing was to assess tracheostomy site every shift and suction every 3 hours as needed. Nursing was to assess heart rate and rhythm every shift. P2 had a history of suicidal attempts, nursing to assess and monitor. P2 required total care with ADL’s. The POC further indicated 16-20 hours of complex RN, LPN, PDN daily 4-7 days a week. P5’s POC dated 2/21/23 – 4/22/23, indicated P5 was diagnosed with chronic respiratory failure. Under the title Safety Measures P3 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P5 was ventilator dependent, had a tracheostomy and required tube feedings. P5 required staff to reposition her every two hours in bed and for transfers the use of the Hoyer lift and two staff members. P5 required twice daily tracheostomy cares including suctioning every three hours as needed. Staff were to assess P5’s respiratory status every shift and perform spot SPO2 checks. P5 was incontinent of bowel. P5 is unable to notify staff when cares are needed. The POC further indicated 16-24 hours complex RN, LPN, PDN, 4-7 days a week. Upon interview on 4/10/23, at 2:48 p.m. P1 stated he is not certain what staff are supposed to be doing for him. P1 stated he was not involved in his care planning process and his plan of care. He stated, “I would like consistency and a calendar of approximate times cares will be done.” P1 stated he has dressing changes and he is not aware what the physician order for the wound care is. P1 stated he does not get out of bed most days because there is no schedule and staff tend to his needs “whenever”. P1 stated he has an order to have range-of-motion exercises, but he is not aware of frequency, or the motions needed to be done. In addition, P1 stated he would like exercises he can do on his own, was not sure why he only receives a bed bath, and he was uncertain if staff should be using a Hoyer lift when he gets up and questioned why he only receives bed baths. Upon interview on 4/10/23 at 2:15 p.m. P2 stated he does not have a POC. He stated he is not certain what cares and services staff are supposed to do and when, and he has not been part of his assessment or planning process since living in the home. P2 stated that he gets bed baths a couple of times of week, depending on the staff is working, staffs cook and clean. P2 stated he was not certain when his bath days were and if he could be taking showers. P2 did not know if he was supposed to be repositioned throughout the day. P2 stated he has not been a part of the assessment process since living at the home. Upon interview on 4/10/23, at 3:16 p.m. RN-A stated she often works with P1 and P2. She stated P1 and P2 should each have their own nurse but does what she can throughout the day. RN-A stated if she has time with cooking, and other tasks, she will give a bed bath, if not it has to wait. She stated she prioritizes her cares. RN-A stated somedays she is very busy with one resident and the other one doesn’t get as much “attention”. RN-A stated she is unaware when the nurses do the assessments. She may just see a change to the medications or treatments in the computer. Upon interview on 4/17/23 at 12:29 p.m. RN-G state she does not involve patients in the plan of care on recertification and does not give patients a copy of their POC. Upon interview on 4/19/23, at 1:03 p.m. P5’s family member (FM)-A stated he has not been involved in P5’s POC. He stated he had reached out to the Administrator and DON multiple times requesting the plan of care since P5’s admission on 2/22/23 and P5’s medication list. He did not receive the information requested. P5 is nonverbal and FM-A is her legal guardian. A policy for the plan of care was requested but was not provided.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure the plan of care for 5 of 5 patients (P1, P2, P3, P4 and P5) reviewed accurately identified the frequency and duration of visits made to patients and other caregiver services patients were receiving when nursing services were not delivered. P1’s plan of care for certification period 1/30/23 - 3/31/23 indicated under the heading Frequency and Duration of Visits P1 received services 16-24 hours complex RN/LPN daily 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P1 included private duty nurses (PDN) services, durable medical equipment (DME) team, nursing services, respiratory therapy, physician, and family. P1’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P1’s patient-specific needs. P2’s plan of care for certification period 1/26/23 - 3/27/23 indicated under the heading Frequency and Duration of Visits P2 received complex RN/LPN PDN services an average 16 to 20 hours up to 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P2 included PDN services, DME team, respiratory therapy, main physician, and spouse. P2’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P2’s patient-specific needs. P3’s plan of care for certification period 4/5/23 - 6/4/23 indicated under the heading Frequency and Duration of Visits P3 received complex RN/LPN PDN an average 16 to 24 hours nursing up to 3-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P3 included PDN, DME team, respiratory team, main physician, wife, and mother. P3’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P5’s patient-specific needs. P4’s plan of care for certification period 1/08/23 - 3/9/23 indicated under the heading Frequency and Duration of Visits P4 received complex PDN services an average 12 to 24 hours up to 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P4 included primary doctor, nurses, pharmacy, and respiratory therapy. P4’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P4’s patient-specific needs. P5’s plan of care for certification period 2/21/23 - 4/22/23 indicated under the heading Frequency and Duration of Visits P5 received complex RN/LPN PDN services an average 16 to 24 hours up to 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P included PDN services, DME team, respiratory therapy, main physician and family member. P5’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P5’s patient-specific needs. Upon interview on 4/11/23, at 11:08 a.m. the director of nursing (DON) stated the agency tries to staff all the clients in the homes with a one-to-one nurse. The agency doesn’t have the staffing to provide the cares 24 hours with one nurse, therefore the cares are shared in the home by the nurses available at that time. She stated the agency can’t guarantee 24 hours nursing cover at a one-to-one ratio. “We know they are cared for 24 hours a day because we always have staff in the homes.” She stated the agency is not set-up for specific hours for each patient, as most patients’ cares are variable. A policy for the plan of care was requested but was not provided.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on the number and/or severity of the deficiencies cited the home health agency failed to meet the Condition of Participation: Organization and Administration Services 42 CFR 484.105. An Immediate Jeopardy (IJ) began on 4/12/23 when the administrator and/or clinical manager failed to have oversight of patient and personnel assignments, and respond to nurse phone calls and/or text messages during hours of operation. Nursing staff were working up to and more than 24 continuous hours fatigued and exhausted risking the health and safety of patients who were dependent on nursing care and services for patients at risk for respiratory failure due to tracheostomy and ventilator dependence, and quadriplegic. Refer to G950: The agency failed to ensure the availability and timely response of a clinical manager for staff providing nursing care and services for 5 of 5 patients (P1, P2, P3, P4, and P5) reviewed. Nursing staff attempted to call and text the director of nursing (DON) and administrator for shift relief when fatigued by working up to and more than 24 continuous hours with medically complex patients who were at risk for respiratory failure due to tracheostomy and ventilator dependence as well as quadriplegic patients requiring total assistance. Refer to G960: The agency failed to provide oversight of patient assignments for five complex patients for 5 of 5 patients (P1, P2, P3, P4 and P5) reviewed. Nursing staff were fatigued and exhausted when scheduled and not relieved of duty providing care and services up to and more than 24 continuous hours for patients who were at risk for respiratory failure due to tracheostomy and ventilator dependence as well as quadriplegic patients requiring total assistance.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation, interviews, and document review, the agency failed to ensure the availability and timely response of a clinical manager for staff providing nursing care and services for 5 of 5 patients (P1, P2, P3, P4, and P5) reviewed. Nursing staff attempted to call and text the director of nursing (DON) and administrator for shift relief when fatigued by working up to and more than 24 continuous hours with medically complex patients who were at risk for respiratory failure due to tracheostomy and ventilator dependence as well as quadriplegic patients requiring total assistance. During observation and interview on 4/13/23, at 8:08 a.m. at the Thurber House, Registered nurse (RN-A) was found pacing the floor, sobbing, and shaking. RN-A stated she was ready to call 911 and report she could not get ahold of the agency management and tell the police she was not able to provide safe cares due to long working hours with no relief in-sight. RN-A had been at the house for over 24-hours and there is no staff to relieve her on the upper level. RN-A was caring for P1 and P2. RN-A stated this happens frequently. RN-A stated her first call to the agency was on 4/12/23, at 6:19 p.m. to the director of nursing (DON). RN-A did not receive a response. RN-A carried out cares until she had time to call again at 9:05 p.m. RN-A made calling attempts on 4/12/23, at 9:06 p.m., 9:12, p.m. 9:17 p.m., 9:24 p.m. and 9:33 p.m. RN-A stated she also sent a text message to the DON and the administrator at 9:08 p.m. with no response. On 4/12/23, at 9:50 p.m. the DON answered the call from RN-A. RN-A stated the DON told RN-A she needed to stay the night and the DON would work on staff to relieve her in the morning. On 4/13/23, there was no staff to relieve RN-A at 7:00 a.m. At 8:18 a.m. RN-A attempted to call the DON and again at 8:21 a.m., 8:29 a.m., 9:57 a.m. and 10:46 a.m. At 10:50 a.m. the DON answered the call and told RN-A that LPN-B was on her way to the house. RN-A called LPN-A and asked when she would be arriving at the house and LPN-A stated she did not pick-up the shift and is not working. RN-A text the DON at 10:55 a.m. writing “She is not coming, please, I need to leave.” The DON immediately responded that she would call LPN-A again. RN-A called LPN-A sobbing on the phone asking her to please relieve her after her appointment. LPN-A arrived at the home at 12:40 p.m. on 4/13/23. During an observation and interview on 4/13/23, at 10:12 a.m. RN-B was providing cares in the Thurber house on the lower level to three complex ventilator dependent clients, P3, P4 and P5. RN-B was scheduled to work 4/11/23, from 7:00 p.m. through 4/12/23, 7:00 a.m. RN-B worked from 4/11/23, 10:00 p.m. through 4/13/23, at approximately 7:00 p.m. for a total of 33 hours. RN-B stated he received a four-hour break at “some point” on 4/12/23. RN-B stated he started calling the DON and the administrator at 8:09 a.m. He stated because he did receive a four-hour break that he was o.k. to be working but needed to leave by 2:30 p.m. on 4/13/23. RN-B stated in the past he would send a group text message to the DON and administrator, but the administrator has never responded to him. He stated if he keeps calling, the DON will “eventually” answer the call. The DON sent RN-B a text message at 10:50 a.m. stating if she could not find staff replacement, she would relieve him by 2:30 p.m. At 2:05 p.m. RN-B called the DON to see when his replacement was going to arrive. The DON told him that she was unable to come and asked him to stay, but she would make more calls to find replacement. RN-B told the DON he was unable to stay past 2:30 p.m. By 2:15 p.m. RN-B again called the DON, and she informed him she was unable to find a staff member and he would have to stay. RN-B stayed until 7:00 p.m. P1's plan of care (POC) dated 1/30/23 – 3/31/23, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, and neurogenic bladder P1 had a gastrostomy tube (G-tube), indwelling foley catheter, and a tracheostomy. Under the title Safety measures, P1 required fall, seizure, respiratory, and obstructed tracheostomy precautions. P1 was incontinent of bowel. Staff was to change his incontinent brief and reposition him in bed every two hours. P1 had a sacral wound with daily orders for dressing change, a right lower leg wound with wound care orders for three times a week, a coccyx wound with orders cleanse after each bowel movement, a heel wound with three times a week orders. Skilled nurse may provide range of motion exercises to client. Skilled nurse was to assess respiratory status each shift and perform oxygen saturation (SP02) throughout the shifts, in addition suction tracheostomy every 3 hours as needed. P1 required total assistance with activities of daily living (ADL’s), P1 required tracheostomy and G-tube care twice daily. The POC further indicated complex registered nurse (RN), licensed practical nurse (LPN) or private duty nursing (PDN) services 16-24 hours 4-7 days a week. P2's POC dated 1/26/23 – 3/27/23, indicated P2 was diagnosed with acute respiratory failure, cardiovascular accident, and mitral valve replacement. Under the title Safety Measures P2 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P2 was incontinent of bowel and bladder, he required staff to reposition him every one-two hour. Nursing was to monitor and manage P2’s blood glucose levels. Nursing was to assess tracheostomy site every shift and suction every 3 hours as needed. Nursing was to assess heart rate and rhythm every shift. P2 had a history of suicidal attempts, nursing to assess and monitor. P2 required total care with ADL’s. The POC further indicated 16-20 hours of complex RN, LPN, PDN daily 4-7 days a week. P3’s POC dated 4/5/23 – 6/4/23, indicated P3 was diagnosed with chronic respiratory failure, morbid obesity, Type 2 Diabetes, and heart failure. Under the title Safety Measures P3 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P3 was a fall risk and was not to be left alone. P3 was to be up in his recliner daily using a Hoyer lift and two staff members. P3 was ventilator dependent, he had a tracheostomy, required tube feedings, and an indwelling foley catheter. P3 required staff to reposition him in bed every two hours and to check that his feeding tube was intact every hour. P3 was to receive a respiratory assessment every shift and SPO2 spot checks during the day and night. P3 was total assistance with ADL’s. The POC further indicated 16- 24 complex RN, LPN, PDN services 4-7 days a week. P4’s POC dated 1/8/23 – 3/9/23, indicated P4 was diagnosed with acute respiratory failure and Becker muscular dystrophy (an inherited disorder that involves slowly worsening muscle weakness of the legs and pelvis). P4 was ventilator dependent, had a tracheostomy and required tube feedings. P4 required staff to reposition him every two hours in bed. He required wound care to the gluteus folds twice daily and as needed sacred and coccyx wound care treatment three times weekly. P4 required tracheostomy cares every eight hours. P4 required total feeding through G-tube. P4 required the use of a Hoyer lift and two staff members to get out of bed. The POC further indicated 12-24 complex PDN for 4-7 days a week. P5’s POC dated 2/21/23 – 4/22/23, indicated P5 was diagnosed with chronic respiratory failure. Under the title Safety Measures P3 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P5 was ventilator dependent, had a tracheostomy and required tube feedings. P5 required staff to reposition her every two hours in bed and for transfers the use of the Hoyer lift and two staff members. P5 required twice daily tracheostomy cares including suctioning every three hours as needed. Staff were to assess P5’s respiratory status every shift and perform spot SPO2 checks. P5 was incontinent of bowel. P5 is unable to notify staff when cares are needed. The POC further indicated 16-24 hours complex RN, LPN, PDN, 4-7 days a week. On 4/13/23 at 12:02 p.m. a representative of the Minnesota Department of Health left an urgent message for the administrator requesting a call back to conduct an interview. The representative did not receive a return call. On 4/13/23 at 12:13 p.m. – 12:15 p.m. a representative of the Minnesota Department of Health left three phone call attempts to the DON. An automated reply indicated that the Verizon customer was not available. There was no option to leave a message. During an interview on 4/13/23, at 12:20 p.m. RN-A and RN-B both verified the number dialed was correct and the same number they use to reach out to the DON. RN-A and RN-B stated the DON turns her phone off when she is busy. On 4/14/23 at 11:11 a.m. the DON stated at time she does not answer the phone calls from nurses because the nurses continually call her throughout the day and night. The DON stated she is currently completing many tasks such as scheduling, payroll, and providing direct patient care. An agency policy related to schedules was requested but not received.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on observations, interview, and document review the agency failed to provide oversight of patient assignments for five complex patients for 5 of 5 patients (P1, P2, P3, P4 and P5) reviewed. Nursing staff were fatigued and exhausted when scheduled and not relieved of duty providing care and services up to and more than 24 continuous hours for patients who were at risk for respiratory failure due to tracheostomy and ventilator dependence as well as quadriplegic patients requiring total assistance. During an observation and interview on 4/13/23, at 8:08 a.m. at the Thurber House, Registered nurse (RN-A) was found pacing the floor, sobbing, and shaking. RN-A stated she had been at the house for over 24-hours caring for P1 and P2 and there is no staff to relieve her for the upper level. RN-A stated this happens frequently. She stated she packs an overnight bag when she goes to work because of having been stranded in the home for days at a time. RN-A was staffed to work with P1 and P2. RN-A stated she could not leave her patients because it would abandonment. She stated the upstairs “never” had two staff scheduled as they are supposed to, therefore, the nurse who works on the upper level does not receive a break. RN-A stated she drinks caffeinated beverages to stay awake through the shifts. RN-A denied sleeping on shifts, even shifts that were over 24-hour consecutive hours. During an observation and interview on 4/13/23, at 10:12 a.m. RN-B was providing cares at the Thurber house on the lower level to three complex ventilator dependent clients, P3, P4, and P5. RN-B was scheduled to work 4/11/23, from 7:00 p.m. through 4/12/23, 7:00 a.m. RN-B worked from 4/11/23, 10:00 p.m. through 4/13/23, at approximately 7:00 p.m. for a total of 33 hours. RN-B stated he received a four-hour break at “some point” on 4/12/23. RN-B was staffed to work with P3, P4, and P5. RN-B stated if two nurses are working in the Thurber house caring for P3, P4, and P5 and he has worked more than 12-hours he will leave, if not he stays until he is relieved by another nurse. RN-B was not able to leave his scheduled 12-hour shift on 4/12/13 because there was no nurse to replace him. RN-B stated, one nurse alone cannot safely provide cares to P3, P4 and P5. He stated, “I could be in one room and with the noise of the machines, I may not hear another patient needing emergency assistance and that could lead to death.” RN-B denied sleeping during shifts where he has worked 24 or more hours. He stated it is impossible to sleep on the lower level as the cares are constant with P3, P4 and P5. P1's plan of care (POC) dated 1/30/23 – 3/31/23, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, and neurogenic bladder P1 had a gastrostomy tube (G-tube), indwelling foley catheter, and a tracheostomy. Under the title Safety measures, P1 required fall, seizure, respiratory, and obstructed tracheostomy precautions. P1 was incontinent of bowel. Staff was to change his incontinent brief and reposition him in bed every two hours. P1 had a sacral wound with daily orders for dressing change, a right lower leg wound with wound care orders for three times a week, a coccyx wound with orders cleanse after each bowel movement, a heel wound with three times a week orders. Skilled nurse may provide range of motion exercises to client. Skilled nurse was to assess respiratory status each shift and perform oxygen saturation (SP02) throughout the shifts, in addition suction tracheostomy every 3 hours as needed. P1 required total assistance with activities of daily living (ADL’s), P1 required tracheostomy and G-tube care twice daily. The POC further indicated complex registered nurse (RN), licensed practical nurse (LPN) or private duty nursing (PDN) services 16-24 hours 4-7 days a week. P2's POC dated 1/26/23 – 3/27/23, indicated P2 was diagnosed with acute respiratory failure, cardiovascular accident, and mitral valve replacement. Under the title Safety Measures P2 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P2 was incontinent of bowel and bladder, he required staff to reposition him every one-two hour. Nursing was to monitor and manage P2’s blood glucose levels. Nursing was to assess tracheostomy site every shift and suction every 3 hours as needed. Nursing was to assess heart rate and rhythm every shift. P2 had a history of suicidal attempts, nursing to assess and monitor. P2 required total care with ADL’s. The POC further indicated 16-20 hours of complex RN, LPN, PDN daily 4-7 days a week. P3’s POC dated 4/5/23 – 6/4/23, indicated P3 was diagnosed with chronic respiratory failure, morbid obesity, Type 2 Diabetes, and heart failure. Under the title Safety Measures P3 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P3 was a fall risk and was not to be left alone. P3 was to be up in his recliner daily using a Hoyer lift and two staff members. P3 was ventilator dependent, he had a tracheostomy, required tube feedings, and an indwelling Foley catheter. P3 required staff to reposition him in bed every two hours and to check that his feeding tube was intact every hour. P3 was to receive a respiratory assessment every shift and SPO2 spot checks during the day and night. P3 was total assistance with ADL’s. The POC further indicated 16- 24 complex RN, LPN, PDN services 4-7 days a week. P4’s POC dated 1/8/23 – 3/9/23, indicated P4 was diagnosed with acute respiratory failure and Becker muscular dystrophy (an inherited disorder that involves slowly worsening muscle weakness of the legs and pelvis). P4 was ventilator dependent, had a tracheostomy and required tube feedings. P4 required staff to reposition him every two hours in bed. He required wound care to the gluteus folds twice daily and as needed sacred and coccyx wound care treatment three times weekly. P4 required tracheostomy cares every eight hours. P4 required total feeding through G-tube. P4 required the use of a Hoyer lift and two staff members to get out of bed. The POC further indicated 12-24 complex PDN for 4-7 days a week. P5’s POC dated 2/21/23 – 4/22/23, indicated P5 was diagnosed with chronic respiratory failure. Under the title Safety Measures P3 required fall, seizure, oxygen, respiratory and tracheostomy precautions. P5 was ventilator dependent, had a tracheostomy and required tube feedings. P5 required staff to reposition her every two hours in bed and for transfers the use of the Hoyer lift and two staff members. P5 required twice daily tracheostomy cares including suctioning every three hours as needed. Staff were to assess P5’s respiratory status every shift and perform spot SPO2 checks. P5 was incontinent of bowel. P5 is unable to notify staff when cares are needed. The POC further indicated 16-24 hours complex RN, LPN, PDN, 4-7 days a week. The agency staffing schedule reviewed for dates 4/1/23 to 4/18/23 for the Thurber house where P1, P2, P3, P4, and P5 reside indicated RN-C, RN-A, RN-B, RN-G, and RN-F were consistently scheduled more than 12-hours in a 24-hour period. · On 4/3/23, RN-C was scheduled 7:00 a.m. through 4/4/23, 12:00 a.m. (36-hours total) · On 4/4/23, RN-A was scheduled 7:00 a.m. through 4/6/23, 7:00 a.m. (48-hours total) · On 4/7/23, RN-C was scheduled 7:00 a.m. through 4/9/23, 7:00 a.m. (48-hours total) · On 4/8/23, RN-B was scheduled 7:00 a.m. through 4/9/23, 7:00 a.m. (24-hours total) · On 4/9/23, RN-A was scheduled 7:00 p.m. through 4/11/23, 7:00 a.m. (37-hours total) · On 4/10/23, RN-G was scheduled 7:00 p.m. through 4/12/23, 7:00 a.m. (37-hours total) · On 4/10/23, RN-C was scheduled 10:00 p.m. through 4/11/23, 12:00 p.m. (21-hours total) · On 4/12/23, RN-B was scheduled 7:00 p.m. through 4/13/23, 7:00 a.m. (12-hours total) · On 4/15/23, RN-F was scheduled 11:30 p.m. through 4/18/23, 7:00 a.m. (55.5-hours total) · On 4/16/23, RN-A was scheduled 7:00 p.m. through 4/18/23,7:00 a.m. (36-hours total) Upon interview on 4/11/23 at 4:02 p.m. the director of nursing (DON) stated the agency does not schedule the client’s for more than 12-hour shifts and she was not aware nurses are working more than 12-hours until she processes payroll. An agency scheduling policy was requested but not received.

On 2/14/23 to 2/27/23, a complaint survey was conducted. This resulted in a partially extended survey at Olidia Care, Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure the provision of quality care. Based on the number and/or severity of the deficiencies cited the Condition of Participation: Patient Rights 42 CFR 484.45 at G406 and Condition of Participation: 42 CFR at 484.100 at G848 was found not met. H81548362C (95911), and H81548051C (95711) were substantiated. Deficiencies were issued at G430, G488, G574, G608, G614, G710, and G848 as a result of the complaint investigation. In addition, H81548463C (96138) was unsubstantiated with no deficiencies cited.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on the number and/or severity of the deficiencies cited the home health agency (HHA) failed to meet the Condition of Participation at 484.50, Patient Rights. The agency failed to ensure 2 of 2 patients (P2 and P5 ) were not neglected when no nursing staff was at the patient's home when P2 arrived home after school and P5 returned home with emergency medical technician (EMT) after a hospital discharge. P2’s parent was called to pick up P2 and the EMT’s for P5 waited in the home for 45 minutes until nursing staff arrived. Refer to G430: The agency failed to ensure neglect did not occur for 2 of 2 patients (P2 and P5) reviewed for neglect. P2 who was dependent on a feeding pump, humidifier, and oxygen tank was brought to his home with no staff present or available leaving his parents to pick him up and keep him for over four hours. P5 who was dependent on tube feeding, trach, and the suction machine was dropped off by paramedics with no nursing staff present or available leaving the emergency medical technicians (EMT) to wait 45 minutes for nursing staff to arrive.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on observation, interview, and document review the agency failed to ensure neglect did not occur for 2 of 2 patients (P2 and P5) reviewed for neglect. P2 who was dependent on a feeding pump, humidifier, and oxygen tank was brought to his home with no staff present or available leaving his parents to pick him up and keep him for over four hours. P5 who was dependent on tube feeding, trach, and the suction machine was dropped off by paramedics with no nursing staff present or available leaving the emergency medical technicians (EMT) to wait 45 minutes for nursing staff to arrive. Review of P2's Service Agreement dated 10/11/21, indicated "Olidia Care is a professional health care provider licensed under the Minnesota Statutes 144A.43 to 144A.47799. We are an independent home care agency that was originally formed to meet the needs of technology-dependent patients of all ages. Olidia Care Inc. has a comprehensive home care license with the Minnesota Department of Health. The service provided is for people who, because of an illness, disability, or physical condition, cannot perform the tasks for themselves or travel to receive health care services". Although the facility had a service agreement there was no contingency plan in place for situations when there was no staff in the home when P2 would arrive home with no staff present. P2's plan of care (POC) for the certification period 1/03/23 through 3/04/23, indicated P2 had type 2 diabetes, epilepsy (seizure disorder), gastrostomy, feeding pump, humidifier, oxygen, and portable suction machine. The POC indicated P2 received feeding and medications by g-tube, was dependent on all care and received oxygen 24 hours per day via mask and the nurse and caregivers are to assess respiratory status every shift and as needed, and report any abnormal findings to the primary doctor and family members. An average 6-24 hours complex private duty nursing 3-7 days a week x 60 days to observe and assess the client's cardiac status, respiratory status, GI/GU status, neurological, and to remain safe in the group home and be free of infection. P2's POC indicated he attends school and his family supports him by riding the transportation bus to pick up and drop him off from his home without being accompanied by a caregiver. P5's Service Agreement with Olidia Home Care dated 4/15/21, indicated "Olidia Care is a professional health care provider licensed under the Minnesota Statutes 144A.43 to 144A.47799. We are an independent home care agency that was originally formed to meet the needs of technology-dependent patients of all ages. Olidia Care Inc. has a comprehensive home care license with the Minnesota Department of Health. The service provided is for people who, because of an illness, disability, or physical condition, cannot perform the tasks for themselves or travel to receive health care services". Although the facility had a service agreement there was no contingency plan in place for situations when there were no nurses in the home and when P5 would return from the hospital with no nurses present. P5's POC for the certification period 1/30/23 through 3/31/23 indicated P5 had acute hypoxia (low oxygen) respiratory failure with hypoxia, tracheostomy (an opening created at the front of the neck so a tube can be inserted into the windpipe to help you breathe), tube feeding, received all medication via G-tube. P5's POC indicated he was to receive skilled nursing services on average of 12-24 hours/day 3-7 days a week for up to 60 days due to the complex needs of the client and client needs. During an interview on 2/15/23, at 3:00 p.m. P2's family member (FM)-A stated on 1/26/23 at 3:00 p.m. she received a phone call from P2's school indicating the school bus had arrived at his home and there was no staff at the home to let P2 into the house. FM-A stated she called the director of nursing (DON) who advised FM-A to pick up P2 with their handicapped van and bring him to their house until 7:00 p.m. when the agency felt they would have staff available at the home. FM-A stated P2's tube feeding ran out at 6:00 p.m. at their home and they had no supplies to continue his feeding until he returned to the Nobel house. Email correspondence dated 2/15/22, from P2's family member (FM)-A in the email indicated she was at the house for a meeting when [P2] got home from school. There was only one staff. There was only one other client, but the staff had to leave the house to get [P2] off the bus, leaving the other client alone. In addition, FM-A stated she had asked about staff for [P2] if they don't send him to school. They don't schedule someone for him when he's not there, so my concern is there isn't staff for him when they keep him home from school. During an interview on 2/15/23, at 3:14 p.m. the DON stated there are three clients in the home, and on 1/26/23, P1 and P5 were sent to the hospital. When P2 returned from school she thought the staff member working might have been in the basement and did not hear the school bus driver ring the doorbell. The DON stated she called the house and the staff did not answer so she told FM-A to pick up P2 and bring him to their house until the staff could arrive home. The DON stated P5 was sent to the hospital and diagnosed with a urinary tract infection (UTI) and returned back to the home the same day by ambulance. The DON stated she thought there was a nurse present at the home when P2 arrived home from school and when P5 returned from the hospital. During an interview on 2/15/23 at 7:10 p.m. the agency staffing coordinator (SC) stated he was informed there was no one at P2's home when he arrived from school on the bus. The SC stated he arrived at the home around 5:00 p.m. and there was no staff at home the other two clients who live there were in the hospital and during that time P5 arrived home from the hospital transported by the EMT's and they had to wait for 45 minutes until a nurse arrived so they could leave since he was not a nurse and P5 required a nurse present. The SC stated there was no nurse scheduled due to no clients being in the home and thought a nurse was supposed to be there but must have been a no-call no-show or stuck somewhere else. The SC was unable to provide a schedule indicating what nurse was scheduled to be in the home when P2 arrived after school. During an interview on 2/16/23, at 9:00 a.m. the DON stated the agency does not require 24-hour nursing care for all clients and the care plan and service agreement indicated 12-24 hour nursing coverage, and in a situation where nursing would not be available, the family would step in for P2. The agency requires family as an available backup as a condition for admission. Facility Abuse and Neglect training undated indicated Neglectful supervision means placing a child in a situation that requires judgment or actions beyond what the child is physically or mentally capable of doing and that results in bodily injury or substantial risk of immediate harm to a child. In addition, the training indicated leaving a child without arranging for necessary care and demonstrating an intent not to return is an example. Failing to allow a child to return home or to arrange for necessary care by others after the child has been absent from the home for any reason. In addition, the training indicated an individual can also commit neglect: "If the person responsible for a child's care, custody and welfare fails to allow a child to return home without arranging the necessary care after the child has been absent from the home for any reason, including run away."

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and document review the home care agency failed to report the allegation of neglect for 2 of 2 patients (P2 and P5) when nursing staff was present to provide necessary care and services. P2 returned to home from school and P5 returned home from the hospital with no licensed nursing staff present to provide care and services. Review of P2's Service Agreement dated 10/11/21, indicated "Olidia Care is a professional health care provider licensed under the Minnesota Statutes 144A.43 to 144A.47799. We are an independent home care agency that was originally formed to meet the needs of technology-dependent patients of all ages. Olidia Care Inc. has a comprehensive home care license with the Minnesota Department of Health. The service provided is for people who, because of an illness, disability, or physical condition, cannot perform the tasks for themselves, or who cannot travel to receive health care services". P2's plan of care (POC) for the certification period 1/03/23 through 3/04/23, indicated P2 had epilepsy, gastrostomy, feeding pump, humidifier, oxygen, and portable suction machine. The POC indicated P2 received feeding and medications by g-tube and average 6-24 hours complex private duty nursing 3-7 days a week x 60 days to observe and assess clients cardiac status, respiratory status, GI/GU status, neurological and to remain safe in the group home and be free of infection. P2's POC further indicated he attends school and his family supports him riding the transportation bus and ok for available transportation to pick up and drop off without being accompanied by a caregiver. Review of P5's Service Agreement dated 4/15/21, indicated "Olidia Care is a professional health care provider licensed under the Minnesota Statutes 144A.43 to 144A.47799. We are an independent home care agency that was originally formed to meet the needs of technology-dependent patients of all ages. Olidia Care Inc. has a comprehensive home care license with the Minnesota Department of Health. The service provided is for people who, because of an illness, disability, or physical condition, cannot perform the tasks for themselves, or who cannot travel to receive health care services". P5’s plan of care for the certification period 1/30/23 to 3/31/23 indicated under the heading Frequency and Duration of Visits P5 received services an average 12 to 24 hours of complex nursing up to 3-7 days a week and monthly care manager visits to review medication, supplies, treatment, and reassessment. During interview on 2/15/23, at 3:00 p.m. P2's family member (FM)-A stated on 1/26/23, at 3:00 p.m. received a phone call from P2's school indicating the school bus had arrived at his home and there was no staff at the home to let P2 into the house. FM-A stated she called the director of nursing (DON) who advised FM-A to pick up P2 with their handicapped van and bring him to their house until 7:00 p.m. when the agency felt they would have staff available at the home. FM-A stated P2's tube feeding ran out at 6:00 p.m. at their home and had no supplies to continue his feeding until he returned to his home. During interview on 2/15/23, at 7:10 p.m. the agency staffing coordinator (SC) stated he was informed there was no one at P2's home when he arrived from school on the bus. The SC stated he arrived at the home around 5:00 p.m. and there was no staff at the home and the other two clients who live there were in the hospital and during that time P5 arrived home from the hospital transported by the EMTs and they had to wait for 45 minutes until a nurse arrived so they could leave since he was not a nurse and P5 required a nurse present. The SC stated there was no nurse scheduled due to no clients being in the home and thought a nurse was supposed to be there but must have been a no-call no-show or stuck somewhere else. The SC was unable to provide a schedule indicating what nurse was scheduled to be in the home when P2 arrived after school. During interview on 2/16/23, at 9:00 a.m. the DON stated the agency does not require 24-hour nursing care for all clients and the care plan and service agreement indicated 12-24 hour nursing coverage, and in a situation where nursing would not be available the family would step in for P2, and the agency requires family as an available back-up as a condition for admission. The DON further indicated she did not feel this should be reported to the SA since it was just considered a missed visit since the clients rent the home and it was not a group home. Facility Abuse and Neglect training undated indicated mandated reporters are individual providers and operators of a facility, employees of home care, home health agencies, and health care providers and "as a mandatory reporter, you must by law make a report if you reason to believe abuse, abandonment, neglect, or financial exploitation of a vulnerable adult has occurred."

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and document review the agency failed to ensure the plan of care for 3 of 3 patients reviewed (P1, P2, and P5) accurately identified the frequency and duration of visits made to patients and other caregiver services patients were receiving when nursing services were not delivered. P1’s plan of care for certification period 1/1/23 to 3/2/23 indicated under the heading Frequency and Duration of Visits P1 received services up to 24 hours complex nursing daily 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P1 included nursing services, durable medical equipment, respiratory, physician, school therapist and teacher. P1’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P1’s patient-specific needs. P2’s plan of care for certification period 1/3/23 to 3/4/23 indicated under the heading Frequency and Duration of Visits P2 received services an average 6 to 24 hours of complex nursing up to 3-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P2 included nursing services, durable medical equipment, respiratory, physician, and parent. P2’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P2’s patient-specific needs. P5’s plan of care for certification period 1/30/23 to 3/31/23 indicated under the heading Frequency and Duration of Visits P5 received services an average 12 to 24 hours of complex nursing up to 3-7 days a week and monthly care manager visits to review medication, supplies, treatment, and reassessment. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when complex nursing care and services are not being delivered by the agency. Under the heading Disciplines Involved in Providing Care listed for P5 included nursing services, case managers, durable medical equipment, physician, physical therapy, occupational therapy. P5’s plan of care does not identify other care givers services provided when complex nursing care visits are not conducted to meet P5’s patient-specific needs. An email correspondence with the agency director of nursing (DON) dated 3/01/23 indicated the DON's response "We do not Guarantee 24-hour nursing care for all clients. Their care plan and service agreement state 12 - 24 hours of nursing coverage. In a situation where nursing is not available, the family steps in as in the case of [P2]. We require that a trained caregiver is available as backup as a condition for admission." A policy for the plan of care was requested but was not provided.

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 interview and document review the agency failed to coordinate the delivery of care to meet the needs of the patient for 3 of 3 patients reviewed (P1, P2, and P5) for care activities when nursing services were scheduled and/or not provided by the agency. The patient and patient representative were not involved in the coordination of care delivery and activities. During observation on 2/14/23, from 12:47 p.m. to 3:45 p.m. at the Nobel House, the office manager was present and licensed practical nurse (LPN)-A, where P1, P2, and P5 live. P5 was lying in bed in his room. P2 arrived home from his school transportation at 3:03 p.m. and P1 returned home from a scheduled appointment at 3:05 p.m. with the director of nursing (DON) and was placed into her bed with LPN-A. P1’s plan of care for the certification period 1/1/23 to 3/2/23 indicated under the heading Frequency and Duration of Visits P1 received services up to 24 hours of complex nursing daily 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when the agency is not delivering complex nursing care and services. Under the heading Disciplines involved in Providing Care listed for P1 included nursing services, durable medical equipment, respiratory, physician, school therapist, and teacher. P1’s plan of care does not identify other caregivers' services provided when complex nursing care visits are not conducted to meet P1’s patient-specific needs. P1’s care schedule indicated P1 received only nursing service from 1/01/23 to 1/31/23: On 1/02/23- 19.00 hours On 1/03/23- 12.00 hours On 1/04/23- 23.00 hours On 1/05/23- 13.00 hours On 1/06/23- 16.00 hours On 1/07/23- 12.00 hours On 1/08/23- 17.00 hours On 1/09/23- 24.00 hours On 1/10/23- 24.00 hours On 1/11/23- 22.00 hours On 1/12/23- 20.00 hours On 1/13/23- 12.75 hours On 1/14/23- 24.00 hours On 1/15/23- 12.00 hours On 1/16/23- 24.00 hours On 1/17/23- 24.00 hours On 1/18/23- 22.00 hours On 1/19/23- 19.00 hours On 1/20/23- 17.00 hours On 1/21/23- 24.00 hours On 1/22/23- 19.00 hours On 1/23/23- 12.00 hours On 1/24/23- 15.00 hours On 1/25/23- 17.75 hours On 1/26/23- 10.50 hours On 1/27/23- 0.00 hours P1 was hospitalized On 1/28/23- 0.00 hours P1 was hospitalized On 1/29/23- 0.00 hours P1 was hospitalized On 1/30/23- 0.00 hours P1 was hospitalized On 1/31/23- 5.00 hours P1's schedule was requested for February from the DON and the staffing coordinator and was not received. P1’s medical record did not identify coordination of care that involves the patient, patient representative, and caregivers coordinating care activities when nursing services were not scheduled or provided. A report to the state agency with photos dated 2/08/23, indicated staffing concerns about only one nurse in the Noble home with three dependent patients and felt it was unacceptable when during a visit on 2/05/23, P1 was found soaked in a feeding tube formula, stool from gastrostomy bag leaking, and tracheostomy (a tube inserted for breathing) was covered in secretions and there was only one nurse in the home. In addition, P1's hair was very greasy and matted again. P1 had not received a full shower nor did any of the patients living in the Noble house receiving agency services receive a shower or a bath in the home due to the home lacking a shower or a bath. P1 did not receive her Sabril anti-seizure medication due to an insurance card issue. During an email correspondence on 2/14/23, P1's family member (FM)-B stated she had been to the home several times lately and there had only been one staff present and thought [P1] was to have 1:1 staffing for her complex medical needs and this has not been happening. In addition, FM-B stated she still has not attended school and does not know the schedule for her staffing. P2’s plan of care for the certification period 1/3/23 to 3/4/23 indicated under the heading Frequency and Duration of Visits P2 received services an average 6 to 24 hours of complex nursing up to 3-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when the agency is not delivering complex nursing care and services. Under the heading Disciplines Involved in Providing Care listed for P2 included nursing services, durable medical equipment, respiratory, physician, and parent. P2’s plan of care does not identify other caregivers' services provided when complex nursing care visits are not conducted to meet P2’s patient-specific needs. P2’s care schedule indicated P2 received only nursing service from 1/01/23 to 1/31/23: On 1/01/23- 7.00 hours On 1/02/23- 5.00 hours On 1/03/23- 10.25 hours On 1/04/23- 9.25 hours On 1/05/23- 1.00 hour On 1/06/23- 10.25 hours On 1/07/23- 15.00 hours On 1/08/23- 15.00 hours On 1/09/23- 1.00 hour On 1/10/23- 10.25 hours On 1/11/23- 10.25 hours On 1/12/23- 10.25 hours On 1/13/23- 16.25 hours On 1/14/23- 16.00 hours On 1/15/23- 12.00 hours On 1/16/23- 7.00 hours On 1/17/23- 1.00 hour On 1/18/23- 8.00 hours On 1/19/23- 10.25 hours On 1/20/23- 14.25 hours On 1/21/23- 19.00 hours On 1/22/23- 6.00 hours On 1/23/23- 10.50 hours On 1/24/23- 10.25 hours On 1/25/23- 10.25 hours On 1/26/23- 10.25 hours On 1/27/23- 14.25 hours On 1/28/23- 15.00 hours On 1/29/23- 12.00 hours On 1/30/23- 8.00 hours On 1/31/23- 10.25 hours P2's schedule was requested for February from the DON and the staffing coordinator and was not received. P2’s medical record did not identify coordination of care that involve the patient, patient representative, and caregivers to coordinate care activities when nursing services are not scheduled or provided. Email correspondence dated 2/15/22 from P2's family member (FM)-A in the email indicated she was at the house for a meeting when [P2] got home from school. There was only one staff. There was only one other client, but the staff had to leave the house to get [P2] off the bus, leaving the other client alone. In addition, FM-A stated she had asked about staff for [P2] if they don't send him to school. They don't schedule someone for him when he's not there, so my concern is there isn't staff for him when they keep him home from school. Email correspondence dated 3/2/23 from P2’s family member (FM)-A indicated There is always "supposed" to be a nurse there. I'm not sure about the personal care attendant (PCA) schedule. We are not provided with a schedule of either nurses or PCA. I have asked for one several times but have not been given one. P5’s plan of care for the certification period 1/30/23 to 3/31/23 indicated under the heading Frequency and Duration of Visits P5 received services an average 12 to 24 hours of complex nursing up to 3-7 days a week and monthly care manager visits to review medication, supplies, treatment, and reassessment. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when the agency is not delivering complex nursing care and services. Under the heading Disciplines Involved in Providing Care listed for P5 included nursing services, case managers, durable medical equipment, physician, physical therapy, and occupational therapy. P5’s plan of care does not identify other caregivers' services provided when complex nursing care visits are not conducted to meet P5’s patient-specific needs. P5’s medical record does not identify coordination of care that involve the patient, patient representative, and caregivers to coordinate care activities when nursing services are not scheduled or provided. P5's care schedule indicated P5 received only nursing service from 1/01/23 to 1/31/23: On 1/01/23- 25.00 hours On 1/02/23- 25.00 hours On 1/03/23- 23.00 hours On 1/04/23- 25.00 hours On 1/05/23- 23.00 hours On 1/06/23- 9.00 hours On 1/07/23- 12.00 hours On 1/08/23- 7.00 hours On 1/09/23- 5.00 hours On 1/10/23- 22.00 hours On 1/11/23- 15.50 hours On 1/12/23- 7.00 hours On 1/13/23- 0.00 hours (unknown reason) On 1/14/23- 0.00 hours (unknown reason) On 1/15/23- 12.00 hours On 1/16/23- 5.00 hours On 1/17/23- 24 hours On 1/18/23- 24.00 hours On 1/19/23- 22.00 hours On 1/20/23- 24.00 hours On 1/21/23- 12.00 hours On 1/22/23- 24.00 hours On 1/23/23- 12.00 hours On 1/24/23- 24.00 hours On 1/25/23- 24.00 hours On 1/26/23- 15.50 hours On 1/27/23- 24.00 hours On 1/28/23- 22.00 hours On 1/29/23- 24.00 hours On 1/30/23- 24.00 hours On 1/31/23- 24.00 hours P5's schedule was requested for February from the DON and the staffing coordinator and was not received. Email correspondence dated 3/2/22 from the agency director of nursing (DON) stated "When they are under our care, we ensure there is a nurse. A situation where we cannot provide staffing, we transfer care to a trained caregiver who can be a family member or hospital/emergency staff. When they are not under our care as in this scenario where they both went out of the home, upon arrival, we provide a trained caregiver to take over from the agency providing cares while there were out of the home. In a scenario where we are not able to take over cares due to staff shortage, it is the responsibility of the agency to transfer the clients to transfer to another trained caregiver that is able to do so, like the family member or hospital. If a neglect ever occurred while they were under the care of other agency, we are not responsible for that until a transfer of care is made. in the case of [P5,] a transfer of care from the EMS staff to Olidia care did not take place till a nurse was present. Same with [P2] there was no transfer of care made till it was confirmed that staff was present at the house. As long as they are home, we provide staffing. When we are not able to provide staffing, care is being transferred to a licensed caregiver. When they are out in the community staffing needs to be available in order for us to take over cares." Olidia Care Scheduling And Case Coverage Policy issued 6/12/21, indicated Patients only be admitted with a trained household caregiver, As a condition of acceptance of a new client, staffing coordinators must ensure that enough permanent caregivers are available to cover shifts within the agency comfortable coverage rate. In addition, the policy indicated. The policy lacked to indicate coordination of care with the patient, patient representative, and caregivers to coordinate care activities when nursing services are not scheduled.

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 interview and document review the agency failed to provide written information to the patient or patient representative for two of three residents (P1 and P2) reviewed for coordination of care. P1 and P2 were not provided with a visit schedule, including frequency of visit by the agency and personnel acting on behalf of the agency. P1’s plan of care for the certification period 1/1/23 to 3/2/23 indicated under the heading Frequency and Duration of Visits P1 received services up to 24 hours of complex nursing daily 4-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when the agency is not delivering complex nursing care and services. Under the heading Disciplines involved in Providing Care listed for P1 included nursing services, durable medical equipment, respiratory, physician, school therapist, and teacher. P1’s plan of care does not identify other caregivers' services provided when complex nursing care visits are not conducted to meet P1’s patient-specific needs. P1’s medical record did not identify coordination of care that involves the patient, patient representative, and caregivers coordinating care activities when nursing services were not scheduled or provided. A report to the state agency with photos dated 2/08/23, indicated staffing concerns about only one nurse in the Noble home with three dependent patients and felt it was unacceptable when during a visit on 2/05/23, P1 was found soaked in a feeding tube formula, stool from gastrostomy bag leaking, and tracheostomy (a tube inserted for breathing) was covered in secretions and there was only one nurse in the home. In addition, P1's hair was very greasy and matted again. P1 had not received a full shower nor did any of the patients living in the Noble house receiving agency services receive a shower or a bath in the home due to the home lacking a shower or a bath. P1 did not receive her Sabril anti-seizure medication due to an insurance card issue. During an email correspondence on 2/14/23, P1's family member (FM)-B stated she had been to the home several times lately and there had only been one staff present and thought [P1] was to have 1:1 staffing for her complex medical needs and this has not been happening. In addition, FM-B stated she still has not attended school and does not know the schedule for her staffing. P2’s plan of care for the certification period 1/3/23 to 3/4/23 indicated under the heading Frequency and Duration of Visits P2 received services an average 6 to 24 hours of complex nursing up to 3-7 days a week. The plan does not identify each day with the hours of complex nursing care visits to be made identifying when the agency is not delivering complex nursing care and services. Under the heading Disciplines Involved in Providing Care listed for P2 included nursing services, durable medical equipment, respiratory, physician, and parent. P2’s plan of care does not identify other caregivers' services provided when complex nursing care visits are not conducted to meet P2’s patient-specific needs. P2’s medical record did not identify coordination of care that involve the patient, patient representative, and caregivers to coordinate care activities when nursing services are not scheduled or provided. Email correspondence dated 2/15/22 from P2's family member (FM)-A in the email indicated she was at the house for a meeting when [P2] got home from school. There was only one staff. There was only one other client, but the staff had to leave the house to get [P2] off the bus, leaving the other client alone. In addition, FM-A stated she had asked about staff for [P2] if they don't send him to school. They don't schedule someone for him when he's not there, so my concern is there isn't staff for him when they keep him home from school. Email correspondence dated 3/2/23 from P2’s family member (FM)-A indicated There is always "supposed" to be a nurse there. I'm not sure about the personal care attendant (PCA) schedule. We are not provided with a schedule of either nurses or PCA. I have asked for one several times but have not been given one. Email correspondence dated 3/2/22 from the agency director of nursing (DON) stated "When they are under our care, we ensure there is a nurse. A situation where we cannot provide staffing, we transfer care to a trained caregiver who can be a family member or hospital/emergency staff. When they are not under our care as in this scenario where they both went out of the home, upon arrival, we provide a trained caregiver to take over from the agency providing cares while there were out of the home. In a scenario where we are not able to take over cares due to staff shortage, it is the responsibility of the agency to transfer the clients to transfer to another trained caregiver that is able to do so, like the family member or hospital. If a neglect ever occurred while they were under the care of other agency, we are not responsible for that until a transfer of care is made. With [P2] there was no transfer of care made till it was confirmed that staff was present at the house. As long as they are home, we provide staffing. When we are not able to provide staffing, care is being transferred to a licensed caregiver. When they are out in the community staffing needs to be available in order for us to take over cares." Olidia Care Scheduling And Case Coverage Policy issued 6/12/21, indicated Patients only be admitted with a trained household caregiver, As a condition of acceptance of a new client, staffing coordinators must ensure that enough permanent caregivers are available to cover shifts within the agency comfortable coverage rate. In addition, the policy indicated. The policy lacked to indicate coordination of care with the patient, patient representative, and caregivers to coordinate care activities when nursing services are not scheduled as well as visit schedule including frequency of visit by the agency and personnel acting on behalf of the agency.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and document review the home health agency (HHA) failed to provide skilled professional services as indicated in the plan of care (POC) for 2 of 2 patients (P1 and P2) reviewed for receiving the necessary care and services. (P1) did not receive medications, grooming and (P2) missed medications, school, and bathing. During an observation on 2/14/23, at 1:30 p.m. in the Noble House, there was one bathroom located on the main level. There was a tub/shower area under construction and had no tub or shower in place just sheetrock. Tacked onto the wall were several letters one was a Stop Work order dated 11/16/22, indicating the project was to be stopped due to work without permits. An additional letter dated 1/31/23 indicated a permit was issued for a main-level bathroom remodel. P1's plan of care (POC) for the certification period 1/01/23 through 3/02/23, indicated P1 with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (a condition that affects muscles and movement., by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated P1 received up to 24 hours of complex registered nursing (RN), licensed practical nursing (LPN) private duty nursing (PDN) 4-7 days a week with a complex past medical history including severe static encephalopathy (declining ability to reason and concentrate, memory loss, personality change, seizures, and twitching) from presumed metabolic/neurodegenerative disorder. In addition, P1's POC indicated she received Vigabatrin (Sabril) which is an anti-seizure medication, 500 milligrams (mg) three tablets via G-tube twice daily. In addition to Levocarnitine 20 mg/2ml via G-tube daily sugar-free only (supplemental medication to treat low blood levels of carnitine). The POC indicated staff was to bathe P1 and wash hair on Monday, Wednesday, and Friday. A report to the state agency with photos dated 2/08/23, indicated staffing concerns about only one nurse in the Noble home with three dependent patients and felt it was unacceptable when during a visit on 2/05/23, when P1 was found soaked in a feeding tube formula, stool from gastrostomy bag leaking, and tracheostomy (a tube inserted for breathing) was covered in secretions and there was only one nurse in the home. In addition, P1's hair was very greasy and matted again. P1 had not received a full shower nor did any of the patients living in the Noble house receiving agency services receive a shower or a bath in the home due to the home lacking a shower or a bath. P1 did not receive her Sabril anti-seizure medication due to an insurance card issue. P1's medication administration record (MAR) for the month of January 2023 indicated P1 missed her scheduled Sabril anti-seizure medication on 1/20/23 at 6:00 a.m., 1/21/23 at 6:00 a.m, 1/23/23, at 8:00 p.m. 1/24/23 at 6:00 a.m. and 8:00 p.m., 1/25/23, at 6:00 a.m. and 8:00 p.m. and 1/26/23, at 6:00 a.m. In addition, P1's MAR indicated she also missed her Levocarnitine 200 mg on 1/24/23, at 6:00 a.m., 1/25/23, at 6:00 a.m., and 1/26/23, at 6:00 a.m. Hospital Discharge summary dated 1/31/23, indicated P1 was a "17-year-old female with a history of epilepsy requiring multiple antiepileptics and ketogenic diet to maintain ketosis who presents with breakthrough seizure activity in the setting of increased secretions, fever, and missing vigabatrin for the past 1-2 weeks due to insurance coverage. Found to be COVID-positive for the 3rd time in the past 12 months. Her breakthrough seizure likely represents missing her anti-epileptic medication in addition to a lowered seizure threshold in the setting of acute respiratory infection. During interview on 2/14/23, at 1:00 p.m. the home care agency director of nursing (DON) stated she was aware P1 was out of her Sabril medication for seizures and faxed P1's primary physician on 1/20/23, and did not receive a response and did not followed up even though P1 continued to miss her medication for several days after. The DON stated she was unaware of P1 missing her Levocarnitine and staff should have notified her. During interview on 2/14/23, at 1:10 p.m. licensed practical nurse (LPN)-A stated she worked at the Noble house with P1 and on 2/13/23, she was unable to wash P1's hair due to being the only nurse with all three patients. LPN-A stated it was not possible to complete all of P1’s tasks. During observation and interview on 2/14/23, at 3:16 p.m. P1 returned home from a planned medical appointment with the DON, and it was observed P1 had unclean hair. The DON stated P1 should have had her hair washed on 2/13/23, and was not aware her hair was not washed due to only one nurse working that day. During interview on 2/14/23, at 4:45 p.m. registered nurse case manager (RNCM) from P2’s hospital team stated in the review of their documents they were never informed P1 did not receive her Sabril medication for her seizures, and if they were informed the medication could not be filled due to insurance reasons they could have increased P1's other seizure medications until the situation was resolved. P2's plan of care (POC) for the certification period 1/03/23 through 3/04/23, indicated P2 had epilepsy, type 2 diabetes, epilepsy (seizure disorder), gastrostomy, feeding pump, humidifier, oxygen, and portable suction machine. The POC indicated P2 received feeding and medications by g-tube, was dependent on all care, and received oxygen 24 hours per day via mask the nurse and caregivers are to assess respiratory status every shift and as needed and report any abnormal findings to the primary doctor and family members. and average 6-24 hours complex private duty nursing 3-7 days a week x 60 days to observe and assess the patient's cardiac status, respiratory status, GI/GU status, and neurological and to remain safe in the group home and be free of infection. P2's POC further indicated he attends school and his family supports him riding the transportation bus and ok for available transportation to pick up and drop off without being accompanied by a caregiver. In addition, P2's POC indicated hair was to be washed every other day and provide finger anil care as needed when necessary. In addition, P2's POC indicated P2 received Lyrica (for seizure control) 240 mg/12 milliliters (ml) via G-tube twice daily. P2's MAR for February 2023, indicated P2 did not receive his scheduled Lyrica (given for agitation and pain) on 2/15/23, at 8:00 p.m. and 2/16/23, at 8:00 a.m. due to not being available. Email correspondence from P2's family member (FM)-A on 2/15/23, FM-A stated concerns of P2 had not received a shower or a bath since he moved into the Noble House on 10/11/21. During an email correspondence with P2's family member (FM)-A on 2/15/23, FM-A stated P2 had been receiving Lyrica for many years he was inpatient from 2017 to 2018 he was sedated and count find a cause for his extreme agitation or pain and Lyrica is used as a cocktail to bridge him and is not a medication he should miss. In addition, FM-A addressed her concern about P2 missing school and listed the following reasons in her email: [P2] missed a lot of days at the beginning of the school year, it was reported he was only in school 17 days (which was not many.) 11/2/22 Staff claimed the bus didn't come 11/15/22 Staff claimed the bus didn't come 11/15/22 Staff said I told them [P2] didn't have to go to school if it snowed. That was not said. School is very important to us. 11/16/22 Staff said it was too slippery to get [P2] on the bus (pick-up van goes into the driveway) 11/29/22 Staff said again it was too slippery 12/6/22 Staff called to report there was an incident getting [P2] off the bus (they said they had a video). His wheelchair went off the edge of the ramp and got stuck. Staff was not able to free him so they called 911 to help. Police came and helped get [P2] into the house. He was outside in the cold for 30 minutes. The next day, I contacted the director of nursing a couple of times requesting a copy of the video. I was told it was deleted. 12/14/22 was refused by house staff when returned home from school. Not safe to get him off the bus. He was sent back to school on the bus. The supervisor was there, contacted the parents, and rode back to the house where she helped get to [P2] into the house. He returned over an hour after his scheduled time. 12/15/22 & 12/16/22 [P2] did not show up at school. Not certain if it was weather related or if there was not enough staff to get him ready. 12/24/22 We stopped to visit [P2] and were told his g/j tube was clogged. It was clogged due to not flushing frequently enough with his new food recipe. We had to take him to the ER to have it unclogged 12/31/22 We got a call at 11:00 p.m. [P2]'s tubing was clogged again. They wanted to send [P2] to the ER ALONE. They said the staff needed to leave early and didn't want to get stuck at the ER. 1/26/23 There was nobody at the house when [P2] returned from school. Transportation brought him back to school where, thankfully, the school nurse was still there. They called us to find out what was going on. I tried to contact the house several times and the case manager. I did reach the scheduler at Olidia and was told for sure there was someone at the house. NOT TRUE. We have a handicapped van and were available to pick [P2] up at school. When we finally talked with the director of nursing, she said there would be someone at the house shortly (4:30ish) and would call to confirm. She didn't call, we had to call her back and were told they would not have anyone at the house until 7:00 p.m. We brought [P2] home for a few hours. During this time, [P2]'s feeds ran out. 2/09/23 [P2] didn't go to school. The staff reported he didn't sleep well. When I asked for details, they were vague. I am not certain it wasn't because they didn't have staff to get him ready. 2/10/23 [P2] didn't go to school. No staff to get him ready. 2/13/23 [P2] didn't go to school because the only wheelchair access to the house had a broken door that would not open. FM-A email on 2/15/23 continued with action taken attempting to resolve the above concerns. When the house reported the bus wasn't showing up, transportation pulled GPS records showing the bus was there. We have contacted the owners and management about the lack of a shower/bath since the day he moved in (10/11/21). [P2] has not had a proper bath/shower since he moved there. We have contacted management regarding the safety of the house and the lack of staff if there was an emergency. They report there is an emergency plan, but I don't see how it could work. Especially if they are understaffed. We have contacted management several times regarding the only access for wheelchairs. The ramp is narrow and has no railing I was at the house for a meeting when [P2] got home from school. There was only one staff. There was only one other client, but the staff had to leave the house to get [P2] off the bus, leaving the other client alone. I have asked about staff for [P2] if they don't send him to school. They don't schedule someone for him when he's not there, so my concern is there isn't staff for him when they keep him home from school. During interview on 2/15/23, at 12:00 p.m. the director of nursing (DON) stated they are working on the bathroom remodel and the county will be doing the final inspection after the plumbing is complete hopefully next week and then the floor needs to be tiled. The DON stated the administrator had been working on this with the owner of the home since the agency does not own the home and the clients are renting in the Nobel house. The DON stated the home had never had a tub or shower the clients could use while living in the Noble house. During interview on 2/10/23, at 3:30 p.m. DON stated P2 did not go to school on 2/20/23, due to the night shift nurse leaving the house and refusing to get him ready for school. The staff in the home tried to get him ready but the bus would not wait so he missed school that day. The DON stated she plans to address the situation at the agency board meeting on Friday. The DON stated she was not aware of the other missed days of school. Facility policy on services provided in the plan of care was requested but was not received.

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on interview and document review the agency failed to follow state law when they scheduled nurses over a normal work period of 12 hours incurring mandatory overtime in a 24-hour period for nurses per MN Statute 181.275 Regulating Nurses Overtime for 2 of 2 nurses (RN-C and RN-D) reviewed for patient care. The excessive hours were not a result of unusual, unpredictable, or unforeseen circumstances. According to the Minnesota Department of Labor, Labor Standards for Regulating Nurses Overtime – Minnesota Statutes 181.275 2022 https://www.dli.mn.gov/business/codes-and-laws/laws-and-rules identified definitions “emergency” means a period when replacement staff are not able to report for duty for the next shift or increased patient need, because of unusual, unpredictable, or unforeseen circumstances such as, but not limited to, an act of terrorism, a disease outbreak, adverse weather conditions, or natural disasters which impact continuity of patient care; "normal work period" means 12 or fewer consecutive hours consistent with a predetermined work shift. In addition, health care facility licensed by the commissioner of health, and the facility's agent, is prohibited from taking action against a nurse solely on the grounds that the nurse fails to accept an assignment of additional consecutive hours at the facility in excess of a normal work period, if the nurse declines to work additional hours because doing so may, in the nurse's judgment, jeopardize patient safety. P1's plan of care (POC) for the certification period 1/01/23 through 3/02/23, indicated P1 with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (a condition that affects muscles and movement., by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated P1 received up to 24 hours of complex registered nursing (RN), licensed practical nursing (LPN) private duty nursing (PDN) 4-7 days a week with a complex past medical history including severe static encephalopathy (declining ability to reason and concentrate, memory loss, personality change, seizures, and twitching) from presumed metabolic/neurodegenerative disorder. P5's POC for the certification period 1/30/23 through 3/31/23, indicated P5 had acute hypoxia (low oxygen) respiratory failure with hypoxia, tracheostomy (an opening created at the front of the neck so a tube can be inserted into the windpipe to help you breathe), tube feeding, received all medication via G-tube. P5's POC further indicated he was to receive skilled nursing services on average of 12-24 hours/day 3-7 days a week for up to 60 days due to the complex needs of the client and client needs. P4's POC for the certification period 1/26/23 through 3/27/23, indicated P4 had bipolar disorder (mental disorder), tracheostomy, hypertension, homelessness, and cocaine abuse, and received 16-24 hours of complex RN/LPN PDN 4-7 days/week for the client from basic activities of daily living (ADL)'s to medication management, emergency management and care and coordination with other health care providers. Registered nurse (RN)-C’s work scheduled providing care patients were reviewed. RN-C was scheduled to work the following hours. P1 on 1/2/23 7:00 a.m. to 11:00 p.m. totaling 16 hours. P1 on 1/6/23 7:00 a.m. to 11:00 p.m. totaling 16 hours. P1 on 1/7/23 7:00 a.m. to 7:00 p.m. and; P5 on 1/7/23 7:00 p.m. to 7:00 a.m. on 1/8/23 and; P1 on 1/8/23 7:00 a.m. to 12:00 a.m. and; P1 on 1/9/23 12:00 a.m. to 7:00 p.m. totaling 60 continuous hours from 1/7/23 to 1/9/23. During interview on 2/22/23, at 11:30 a.m. RN-C stated she works every other weekend from 7:00 a.m. to 7:00 p.m. The first weekend in January she worked at the agency's Noble home because there was no staff to come in to relieve her from her shifts. RN-C said she was very exhausted, and the DON came in for one hour to allow her to take a break but other than the one-hour break she worked the entire weekend. RN-D’s work schedule was requested and not provided. RN-D’s clinical notes for patient care were reviewed. RN-D worked the following hours. P4 on 2/16/23 8:00 a.m. to 12:00 a.m. and; P4 on 2/17/23 12:00 a.m. to 7:00 a.m. and; P4 on 2/17/23 7:00 a.m. to 7:00 p.m. totaling 35 continuous hours. During interview on 2/17/23, at 10:00 a.m. RN-D stated she had been working since 2/16/23, at 8:00 a.m. and she had no idea if there was anyone to relieve her after 7:00 p.m. today on 2/17/23, when her shift ended. In addition, RN-D stated the agency wanted her to care for a patient she had never worked for and had no training with. RN-D stated luckily, she did not have to, but they would have scheduled me if they could have. RN-D stated the DON did come in and provided a break for two hours and she had tried to sleep but it did not feel like a break and stated she did not drive due to a seizure history and so going home was not an option for her. RN-D stated this happens all the time with this agency and she was getting tired of it. RN-D provided text messages to the agency the following day on 2/18/23 at 9:24 a.m. indicating she did end her shift on 2/17/23 at 7:00 p.m. and due to the stress from working her blood pressure went up and had two transient ischemic attacks (also known as TIA's mini strokes). RN-D texted the staffing coordinator she could not come back to work on 2/18/23 informing the director of nursing (DON) she would not make it in on 2/18/23 and 2/19/23. The agency still expected her to work on 2/18/23, at 7:00 a.m. In addition, RN-D stated on 2/18/23 the staffing coordinator expected her to work with a patient she had never worked with before and never received any training with. RN-D stated she decided to quit her job due to feeling it was unsafe working with the agency because of being stuck working long hours and their expectations of working with patients without the proper training. An email correspondence dated 3/1/23 with the DON indicated "We do not Guarantee 24 hours nursing care for all clients. Their care plan and service agreement states 12 - 24 hours of nursing coverage. In a situation where nursing is not available, the family steps in as in the case of Nicholas. We require that a trained care giver is available as back up as a condition for admission." Olidia Care Scheduling and Case Coverage Policy dated 6/12/21, indicated "At Olidia Care we have been working with multiple communities and colleges to recruit nurses. We also have a Complex care Clinical Program for nursing students. The agency also started a staffing company called Olidia Staffing with the purpose of connecting the dots in the clinical staffing industry." The Policy further indicated for each patient; the agency has established a daily maximum average number of hours of nursing care that it can cover. We call it the expected coverage rate. It can be 16 hours a day on average. The agency also established a minimum average number of hours that it can comfortably cover with permanent clinicians. We call it the comfortable coverage rate. It can be 8 hours a day. The agency will use the comfortable coverage rate in updated service agreements with patients and physician orders. I there is a change in that comfortable coverage rate, the patient and the physician will be informed and given enough time to adjust.

On 11/1/22 to 11/14/22 a complaint survey was conducted. This resulted in a partial extended survey at Olidia Care, Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Based on the number and/or severity of the deficiencies cited the Condition of Participation: Patient Rights 42 CFR 484.45 at 406 was found not met, and the Condition of Participation: Skilled Professional Services at G700 was found not met. H81545596C (94156 and 94157) were substantiated. Deficiencies were issued at G430, G482, and G710 as a result of the complaint investigation. H8154022C (62418), H81545481C (94106), H81543445C (71278), H81542450C (70892) were substantiated. Deficiencies issued at G536, G574, and G710 as a result of the complaint investigation.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on the number and/or severity of the deficiencies cited the home health agency (HHA) failed to meet the Condition of Participation at 484.50, Patient Rights. The agency failed to ensure 1 of 1 patient (P2) was not neglected when licensed practical nurse (LPN)-A worked excess hours failed to provide medications and treatments for a 12-hour shift and was found unfit to work. This resulted in P2 having respiratory distress in the home needing suctioning, Ambu bag, was sent to the emergency department, and was admitted to the hospital with hypoxia and a mucus plug. Refer to G430: The agency failed to ensure neglect did not occur for 1 of 1 patient (P2), reviewed for neglect. P2 was a ventilator-dependent patient, received tube feeding, oxygen, and had a portable suction machine. P2 did not receive any of his skilled nursing services, medications, or treatments for a 12-hour period by licensed practical nurse (LPN)-A who had worked an excess amount of hours for the agency, was behaving abnormally, and unfit to work. P2's family member notified the agency at 4:00 p.m. and a registered nurse (RN)-G arrived to take over caring for P2 at approximately 11:20 p.m. finding P2 in respiratory distress. RN-G attempted to suction P2 while his oxygen saturation levels dropped to 80%. RN-G then called 911, and P2 was admitted to the hospital with hypoxia (low oxygen level) and mucus plug (when mucus collects in the trach tube or airway and creates a plug blocking air from flowing through the airway). Refer to G482: The agency failed to thoroughly investigate an incident of neglect for 1 of 1 patient (P2) who was a ventilator-dependent patient, received tube feeding, oxygen, and had a portable suction machine. P2 did not receive any of his skilled nursing services, medications, or treatments for a 12-hour period. LPN-A was unfit to work and a registered nurse (RN)-G arrived to take over caring for P2 finding P2 to be in respiratory distress. RN-G attempted to suction him while his oxygen saturation levels dropped to 80%. RN-A then called 911, and P2 was admitted to the hospital with hypoxia (low oxygen level) and mucus plug (When mucus collects in the trach tube or airway and creates a plug. This can block air from flowing through the airway).

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on observation, interview, and document review the agency failed to ensure neglect did not occur for 1 of 1 patient (P2), reviewed for neglect. P2 was a ventilator-dependent patient, received tube feeding, oxygen, and had a portable suction machine. P2 did not receive any of his skilled nursing services, medications, or treatments for a 12-hour period by licensed practical nurse (LPN)-A who had worked an excess amount of hours for the agency, was behaving abnormally, and unfit to work. P2's family member notified the agency at 4:00 p.m. and a registered nurse (RN)-G arrived to take over caring for P2 at approximately 11:20 p.m. finding P2 in respiratory distress. RN-G attempted to suction P2 while his oxygen saturation levels dropped to 80%. RN-G then called 911, and P2 was admitted to the hospital with hypoxia (low oxygen level) and mucus plug (when mucus collects in the trach tube or airway and creates a plug blocking air from flowing through the airway). P2 plan of care (POC) for the certification period 9/23/22 through 11/22/22, indicated P2 was admitted to the HHA on 5/25/22, with diagnosis of acute hypoxemic and hypercarbaric (increased carbon dioxide in the bloodstream) respiratory failure requiring endotracheal intubation (placement of a flexible plastic tube into the trachea to maintain an open airway), status post-extubation and Duchenne muscular dystrophy (wasting of the muscles) and pressure ulcer. In addition, the POC indicated P2 had a ventilator, tube feeding, and was to receive 8 to 24 hours of complex private duty nursing for 5 to 7 days a week for 356 days a year for monitoring and supervision. Review of Text messages between LPN-A and the staffing coordinator (SC) indicated the following: On 10/28/22, at 6:02 p.m. the SC sent a text message to LPN-A "I still don't have anyone to relieve you". LPN-A responded "you need to give me a bonus for me to come in last minute to work for you bro". LPN-A texted "If don't respond I will leave because I have been working six shifts straight for you". No response from SC, and another text from LPN-A, "Im leaving". On 10/29/22, at 7:42 a.m. the SC finally responded [LPN-A] "whzz up? Please stay until I can get another nurse to come". LPN-A responded, "I'm calling the police to take the 3 clients to the hospital now." SC- responded "you can't leave that house right now we fired [nurse..] because of the same behavior". At 9:51 a.m. LPN-A responded "I'm gone". SC texted "If you leave you can't work at the Thurber house any more". SC texted "I will not schedule you at the Thurber house anymore". "I will pay you 10 dollars an hour for the three clients plus 150 or considering to stay while I search for someone to come and work with you. So I owe you total 300 bonus. Pleas 10 hours working for three clients". A review LPN-A schedule provided by the SC indicated the following from 10/24/22 through 10/30/22, the schedule is not reflective of the text messaging from the SC: 10/25/22- Worked 7:00 p.m. to 11:59 p.m. into 10/26/22, 12:00 a.m. to 3:57 p.m. 10/27/22- Worked 8:00 a.m. to 4:15 p.m. 10/28/22 Worked 9:30 a.m. to 5:25 p.m. 10/29/22 Worked 10:00 p.m. to 11:59 p.m. LPN-A paystub was requested from the home health agency three times for the above time period and was not provided. A review of medication administration records (MAR) and treatment administration record (TAR) for the agency's patients indicated additional charting was done that was not on LPN-A's schedule showing additional hours LPN-A had worked from 10/28/22 to 10/29/22 in the Thurber house: On 10/28/22, LPN-A signed out medications for P2 at 8:00 p.m. and for P5 at 8:00 p.m. and 9:00 p.m. On 10/29/22, LPN-A signed out medications for P5 at 8:00 a.m. and 9:00 a.m. On 10/29/22, LPN- A was terminated at 11:30 p.m. A review of P2's MAR on 10/29/22 indicated the following medications not signed off as administered from 8:00 a.m. through 7:00 p.m. - Calcium Carbonate 1250/5 milliliters (ml) (250) milligrams (mg) at 8:00 a.m. (vitamin) - MiraLAX oral powder for reconstitution 17 grams via feeding tube 8:00 a.m. and 7:00 p.m. (constipation) - Senna 10 milliliters (ml) 8:00 a.m. (stool softener) - Oxygen 2- 4 liters as needed increase oxygen saturation - Additional free water 200 ml via G-tube 8:00 a.m. (hydration) - Administer tube feeding Nutren 310 MLS via bolus x five times daily total of 1550 ml, 8:00 a.m. and 4:00 p.m. - Clonidine 0.2 mg 8:00 a.m. (antihypertensive) - Albuterol 3/ml 10:00 a.m. and 4:00 p.m. (to open lungs) - Clonidine 0.2 mg at 2:00 p.m. (hypertension) - Quetiapine 25 mg two tabs at 4:00 p.m. for irritability (an antipsychotic medication) A review of P2's Treatment Administration Record (TAR) on10/29/22 indicated the following treatments were not signed off as provided from 12:00 a.m. through 7:00 p.m. - Toileting, Turing, and repositioning every 2 hours, not signed off for the entire time 12:00 a.m. through 7:00 p.m. - Cough Assist TID (three times a day) and as needed for mobilization of secretions. May use MetaNeb IPV (mobilization of secretions, lung expansion therapy) when available, not signed off at 8:00 a.m. and 2:00 p.m. - Assistance with bathing twice daily and as needed, assist client with oral hygiene with preferred toiletries daily and as needed, and Assist client with grooming and dressing twice daily and as needed, not signed off at 8:00 a.m. - Check and record vital signs every shift. The client is on continuous oximeter monitoring. - Perform skin checks and complete physical and cognitive assessments. Report any abnormal findings to the case manager and physician, not signed off at 8:00 a.m. - Enteral Diet: Replete, 300 ml, 5 times daily via GT bolus feeding + 200 ml free water via GT bolus, 3 times per day 600 ml), not signed off at 8:00 a.m. and 12:00 p.m. - MetaNeb should be done three times a day, not signed off at 8:00 a.m., 10:00 a.m., and 1:00 p.m. - Perform oral suctioning twice daily and as needed, not signed off as done at 10:00 a.m. - Perform passive range of motion (PROM) exercise two times a day, not signed off as done at 10:00 a.m. - Trach Stoma Care Cleanse with soap and water twice a day, change split gauze twice daily and as needed, not signed off as done at 8:00 a.m. - Tracheostomy deep suctioning inline 11 centimeters (cm) every shift and as needed. Trach shallow suction should be done as needed, not signed off as done at 8:00 a.m. - Check ventilator settings Pressure SIMV, Rate 12, PIP 18, PEEP 7, PS 10, PCO2 45-55, 02 & gt; 92. Check Vent settings every shift, not signed off as done at 8:00 a.m. A report submitted to the State Agency (SA) on 10/30/22, indicated concerns for neglect at care facility patient resides. The report indicated the writer interviewed the patient (P2) who shared that yesterday he was not checked on, turned, or fed for 12 hours, and does not have a call light to alert staff of his needs. The patient was expected to yell when he needed help which was very difficult in consideration of his physical limitations including being trach dependent. The writer in the report stated P2 informed them his nurse yesterday sounded intoxicated and made comments on the phone about shooting someone that sounded threatening and scared him. The report indicated P2's father agreed with the concerns and had problems with the agency since August 2022. P2 was admitted to the hospital for safety and coordination of care. P2's Hospital Discharge Summary dated 11/01/22, from the hospital, indicated "[P2] initially presented with concerns with hypoxia (resolved), and concerns of neglect at the care facility, in the setting of a history of Duchenne Muscular dystrophy with trach dependence, quadriplegia, and cardiomyopathy. He is stable to go home". The discharge summary further indicated the problem that led to the hospitalization [P2] was a 19-year-old w/ Duchenne muscular dystrophy w/trach dependence, quadriplegia, cardiomyopathy, who presented with concerns for hypoxia (resolved), and concerns of neglect at the care facility. The discharge summary indicated final diagnoses of Duchenne Muscular dystrophy, concern for unsafe living situation and neglect, cardiomyopathy, and chronic respiratory failure. During an interview on 11/01/22, at 3:48 p.m. the agency administrator stated he was informed of the incident that occurred with P2 and LPN-A on 10/29/22. The administrator stated he had his clinical director (CD) call the home to check on LPN-A twice. Another nurse, who was also working in the home, called, and said something was wrong with LPN-A because he was mumbling his words and not walking coherently. The administrator stated he wished he had called the police to have his blood alcohol level checked but he did not. During an observation and interview on 11/02/22, at 1:39 p.m. P2 was observed lying in bed alert and orientated with a family member (FM)-A next to him and FM-B on his computer. P2 stated on 10/29/22, his nurse was a licensed practical nurse (LPN)-A. P2 stated "the nurse arrived to work around 9:30 a.m. but was not sure because he was sleepy and fell asleep but later in the evening P2 stated he noticed LPN-A was stumbling around with drunk behaviors, his words were slurring, and I had never seen him this way". P2 stated he had not received care for 12 hours and had to be hospitalized. FM-B stated P2 texted him around 4:00 p.m. telling him something was wrong with LPN-A because he had not received any of his medications all day, and had not been repositioned, which was concerning because he had a pressure ulcer. FM-B stated he immediately called the owner to inform him. FM-B stated, "the owner would take care of things right away, but he never did get back to me." In addition, FM-A and FM-B stated P2 was sent to the hospital on 10/29/22, late in the night, and according to the hospital social worker she felt he was neglected for not receiving care for 12 hours. During an interview on 11/04/22, at 8:00 a.m. registered nurse (RN)-H stated the home health agency is short of nursing staff. RN-H stated one of the patients does not have approved nursing hours from the county so the owner expects us to just pick the patient up along with the other two patients we have for an additional $5.00 an hour in the house on Thurber. RN-H stated it was very difficult to care for all three patients since they all received complex private-duty nursing with trach care, ventilators, and the patients require Hoyer lift assistance, it was not safe. In addition, RN-H stated there are many times when you arrive to work as a nurse and you don't know when you will be able to leave your shift because they don't have another nurse to relieve you. During an interview on 11/07/22, at 8:27 a.m. RN-F stated on 10/29/22, she was working at the home LPN-A was working at. RN-F stated she was assigned to a patient upstairs and LPN-A was working downstairs with P2. RN-F stated her patient went to the hospital around 7:30 p.m. and the administrator asked her to go downstairs to help LPN-A. RN-F said she never worked with P2 before but helped LPN-A with two other patients in the house LPN-A was caring for and that she had previously provided cares for. RN-F told LPN-A they could work together. The clinical coordinator called around 10:00 p.m. and asked to speak to LPN-A and then asked to speak with RN-F. RN-F stated she informed the clinical coordinator she did not know if LPN-A was sick, tired, or something but he appeared to be stuttering when walking. RN-F stated she had never worked with LPN-A and did know him. RN-F stated the staffing coordinator sent another nurse because she had never worked with P2. RN-G came to work around 11:20 p.m. and LPN-A left the home. During interview on 11/07/22, at 11:30 a.m. RN-G stated he was called on 10/29/22, to come work at the home P2 was at. RN-G stated when he arrived, he went into P2's room and saw P2 was having difficulty breathing and started to suction him. When P2’s oxygen saturation levels dropped down to 80% RN-G used the Ambu bag and called 911. RN-G stated when the paramedics arrived around 12:00 a.m. they had to work on P2 for approximately 35-45 minutes suctioning him and then finally took him to the hospital where he was admitted. RN-G stated P2 informed him the nurse scheduled that day did not provide any medications or care for him for over 12 hours. RN-G stated he did not notice how LPN-A was behaving as he was with P2 and the paramedics. During interview on 11/09/22, at 9:17 a.m. P2's primary physician (PP)-A stated he was aware prior to the incident that occurred on 10/29/22 that FM-B had been unhappy with the care P2 had been receiving at his home care agency and knew the family was looking at a new placement. PP-A stated he was also informed of the incident that occurred on 10/29/22 and felt the agency should be held accountable to the neglect of care that occurred for P2 not receiving any treatment or medication for 12 hours. The PP-A stated he could not confirm the reason for the mucus plug or hypoxia since P2 had underlying conditions but the lack of care did not help P2’s situation. During interview on 11/14/22, at 1:43 p.m. LPN-A stated he had worked over 20 hours straight from 10/25/22 to 10/26/22, between the Thurber house and Nobel house. On 10/27/22 LPN-A returned to the Nobel house at 8:30 a.m., working until 10/28/22 when he left the Noble house to work at the Thurber house at 8:00 a.m. working until 10/29/22, around 11:30 p.m. (approximately 63 hours straight). LPN-A stated he did work on 10/29/22 with P2 and was forced to work at the Thurber house that day because there was no nurse to relieve him. LPN-A stated he begged the staffing coordinator to let him leave on 10/29/22 in the morning, but no staff came to relieve him. LPN-A stated he had to leave the home to bring his baby to the babysitter, and he was so stressed out and exhausted he just was not himself. LPN-A stated he was not intoxicated that night and would never drink while he was working. LPN-A stated he was not drinking on the job and was extremely upset because the agency was forcing him to work so many hours, and have not paid him. LPN-A stated he had text messages between him and the staffing coordinator where he had asked to be relieved and had proof of documentation on the medication and treatment administration records (MAR/TAR) that he was actually working days they are not showing he worked. During interview on 11/17/22, at 11:03 a.m. CD stated there is charting for patients when LPN-A was not scheduled and was not sure why. The CD stated she was going to reach out to the SC to try and get more information. As of 11/18/22, at 1:00 p.m. there has been no response and no paystubs have been received by the agency after a fourth request had been made. In an additional interview on 11/18/22, at 1:20 p.m. the CD stated LPN-A had not been clocking in and out so they have no information for what hours he had worked after 10/22/22, for his paystub and sometimes does this to bypass the company protocol and then would ask to be paid later. Requested company protocol for staffing and schedule, and was not received. The agency Abuse and Neglect Training dated 2/12/2018, indicated neglectful supervision means placing a child in a situation that requires judgment or actions beyond what the child is physically or mentally capable of doing that results in bodily injury or substantial risk of immediate harm to a child. The training also defined medical neglect as failing to provide a child with medication or medical care necessary to treat a diagnosed medical condition such as diabetes or epilepsy.

Mistreatment, neglect or abuse CFR(s): 484.50(e)(1)(i)(B) (i)(B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and document review the agency failed to thoroughly investigate an incident of neglect for 1 of 1 patient (P2) who was a ventilator-dependent patient, received tube feeding, oxygen, and had a portable suction machine. P2 did not receive any of his skilled nursing services, medications, or treatments for a 12-hour period once the staff realized LPN-A was unfit to work registered nurse (RN)-G arrived to take over caring for P2 found him to be in respiratory distress, attempted to suction him while his oxygen saturation levels dropped to 80%. RN-G called 911, and P2 was admitted to the hospital with hypoxia (low oxygen level) and mucus plug (when mucus collects in the trach tube or airway and creates a plug, which can block air from flowing through the airway). P2 plan of care (POC) for the certification period 9/23/22, through 11/22/22, indicated P2 was admitted to the HHA on 5/25/22, with diagnosis of acute hypoxemic and hypercarbaric (increased carbon dioxide in the bloodstream) respiratory failure requiring endotracheal intubation (placement of a flexible plastic tube into the trachea to maintain an open airway), status post-extubation and Duchenne muscular dystrophy (wasting of the muscles) and pressure ulcer. In addition, the POC indicated P2 had a ventilator and tube feeding. The POC indicated P2 was to receive 8 to 24 hours of complex private duty nursing for 5 to 7 days a week for 356 days a year for monitoring and supervision. A report submitted to the State Agency (SA) on 10/30/22, indicated concerns for neglect at care facility patient resides. The report indicated P2 was interviewed and shared that yesterday he was not checked on, turned, or fed for 12 hours, and does not have a call light to alert staff of his needs. The patient was expected to yell when he needed help which was very difficult in consideration of his physical limitations including being trach dependent. The report indicated P2 informed them his nurse yesterday sounded intoxicated and made comments on the phone about shooting someone that sounded threatening and scared him. The report indicated P2's father agreed with the concerns and had problems with the agency since August 2022. P2 was admitted to the hospital for safety and coordination of care. P2's Hospital Discharge Summary dated 11/01/22, from the Hospital, indicated "[P2] initially presented with concerns with hypoxia (resolved), and concerns of neglect at the care facility, in the setting of a history of Duchenne Muscular dystrophy with trach dependence, quadriplegia, and cardiomyopathy. He is stable to go home". The discharge summary further indicated the problem that led to the hospitalization [P2] was a 19-year-old with Duchenne muscular dystrophy with trach dependence, quadriplegia, cardiomyopathy, who presented with concerns for hypoxia (resolved), and concerns of neglect at the care facility. The discharge summary indicated final diagnoses of Duchenne Muscular dystrophy, concern for unsafe living situation and neglect, cardiomyopathy, and chronic respiratory failure. The home health agency Sentinel Event Root Cause dated 11/4/22, indicated they received a report from a concerned staff that LPN-A was observed to be intoxicated and left the patient with the care of another trained staff who was not initially assigned to the patient. The report indicated the writer called LPN-A and from the conversation, he sounded incoherent and was immediately removed from the care area and replaced with another trained registered nurse (RN). The report indicated the RN who took over care for P2 observed P2 was having respiratory difficulty and sent him to the emergency department after several failed attempts to stabilize him. The agency terminated LPN-A and reported to the Board of Nursing. The report indicated the event occurred on 10/30/22 [sic], and he had a previous history of known alcohol intoxication at his former place of work which was noted on the Board of Nursing license verification page. The report indicated they had added additional cameras in the home and a call light was provided to P2 and he was encouraged to call management with concerns. Staff was also encouraged to report such events or suspicions immediately to management and informed by management any form of intoxication at the workplace will result in immediate termination of appointment of both the staff involved and anyone who refuses to immediately report a known case. The home health agency the investigation lacked an interview with LPN-A, P2, P2’s family members, and other patients in the home. In addition, the agency did not investigate how many hours LPN-A had been working, interview the staffing coordinator, other nurses, and had no evidence of LPN-A’s blood alcohol level to verify he was intoxicated as the report indicated. During interview on 11/01/22, at 3:48 p.m. the agency administrator stated he was informed of the incident that occurred with P2 and LPN-A on 10/29/22. The administrator stated he had his clinical director (CD) call the home to check on LPN-A twice. Another nurse, who was also working in the home, called, and said something was wrong with LPN-A because he was mumbling his words and not walking coherently. The administrator stated he wished he had called the police to have his blood alcohol level checked but he did not. During interview on 11/07/22, at 10:50 a.m. CD stated she thought she had to quickly complete the investigation and discovered their findings the same day of the incident. The CD stated their finding was LPN-A was intoxicated at the time of the shift and it was reported by RN who was working in the home that day and this was verified with the phone conversation with LPN-A. During interview on 11/14/22, at 1:43 p.m. LPN-A stated he had worked over 20 hours straight from 10/25/22 to 10/26/22, between the Thurber house and Nobel house. On 10/27/22 LPN-A returned to the Nobel house at 8:30 a.m., working until 10/28/22 when he left the Noble house to work at the Thurber house at 8:00 a.m. working until 10/29/22, around 11:30 p.m. (approximately 63 hours straight). LPN-A stated he did work on 10/29/22 with P2 and was forced to work at the Thurber house that day because there was no nurse to relieve him. LPN-A stated he begged the staffing coordinator to let him leave on 10/29/22 in the morning, but no staff came to relieve him. LPN-A stated he had to leave the home to bring his baby to the babysitter, and he was so stressed out and exhausted he just was not himself. LPN-A stated he was not intoxicated that night and would never drink while he was working. The agency Abuse And Neglect Training dated 2/12/2018, indicated the agency is responsible for assessing or investigating reports of child maltreatment and has the authority to interview the child, the person or persons responsible for the care, the alleged perpetrator, and any other person with knowledge of the abuse or neglect for the purpose of gathering the facts, assessing safety risk to the child and formulating a plan.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review, the agency failed to ensure 1 of 1 patient (P1) plan of care (POC) was current and up to date according to physician orders to prevent medication errors. P1’s plan of care POC for the certification period 9/01/22 through 10/31/22 indicated P1 was admitted to the home health agency on 9/8/21 with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (condition that affects muscles and movement, by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated she received tube feeding with a ketogenic diet, give 120 milliliters (ml) per hour (hr) until formula is completely gone. The POC indicated P1 received private duty nursing 4-7 days a week. In addition, the POC directed staff to put the patient up in a wheelchair twice daily at 11:00 a.m. and 6:00 a.m. using a Hoyer lift. P1 was to receive Sodium Chloride 0.9% (NS bolus) 1:1 replacement for ostomy output greater than 500 ml with 1:1 NS by G-tube, Magnesium Hydroxide (Milk of Magnesia 8%) take 3 ml by G-tube twice a day; however, P1’s magnesium increased to 4 ml on 9/21/22. Chlorthalidone (for high blood pressure) 25 milligrams (mg) via G-tube daily, Imodium A-D 2 mg tab via g-tube daily for loose stools, Felbamate (seizures) 600 mg one tablet via G-tube three times daily, Amantadine (symptoms of Parkinson's) 100 mg oral take 0.5 tablet via G-tube twice daily. P1’s office clinic notes from P1’s specialty healthcare clinic dated 9/19/22 indicated the provider was unable to reconcile the medications because the medication list was not available from the home health agency. P1’s Milk of Magnesia 8% oral suspension indicated 0.24=3 milliliters (ml), G-tube, twice a day. Review of P1's medication administration record (MAR) dated 9/30/22, indicated P1 was to receive Magnesium Hydroxide (Milk of magnesium 8%) Take 4 ml via G-tube twice daily for constipation. The MAR indicated P1 received 3 ml on 9/29/22 through 10/26/22, not the ordered 4 ml. P1’s nutritional progress notes from P1’s specialty healthcare clinic dated 10/26/22 indicated the P1’s Milk of Magnesia 8% oral suspension was 0.32 =4 ml, G-tube, twice a day. During interview on 11/4/22, at 11:00 a.m. registered nurse case manager (RNCM) from P1’s specialty healthcare clinic stated their medical team have concerns with P1's home health agency with inconsistent medication changes not being completed. RNCM stated P1's Magnesium dose was increased on 9/21/22, from 3 ml to 4 ml due to hypomagnesemia, the orders were faxed to the home health agencies clinical director (CD) on 9/29/22. When P1 returned to the clinic on 10/26/22, the dosage was not changed on the orders. During interview on 11/07/22, at 11:08 a.m. RN-E stated she had only been giving P1 3 ml of Milk of magnesium until 10/26/22 because the CD inputs the medications in the computer system and put in the dosage to give which was 3 ml. In addition, RN-E stated the label on the bottle of Magnesium Hydroxide directs them to give 3 ml twice daily. RN-E stated she will inform the CD the order needs to be changed to have the dosage match the order of 4 ml. During interview on 11/7/22, at 1:45 p.m. the pharmacist stated the only order they had for Magnesium Hydroxide was dated 4/13/22, and it was to give 3 ml twice daily, not 4 ml the agency orders read. The pharmacist stated the home, or the physician needs to be sending scripts to the pharmacy, so the orders are accurate. P1's plan of care (POC) for the certification period 11/01/22 through 12/31/22, indicated P1 was admitted to the HHA on 9/08/21, with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (condition that affects muscles and movement, by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated she received tube feeding with a ketogenic diet, and free water. The POC further indicated P1 received private duty nursing 4-7 days a week and instructed the nurses to double-check all medication sheets upon arrival to the home. The POC directed nursing to check the six rights of medication administration before any medication is administered and to see the electronic medication administration record (EMAR) for the most current medication profile. The POC indicated two orders for Diazepam (used to treat symptoms of seizure). The first order listed indicated Diazepam 10 milligrams (mg) (Diastate Acudial 10 mg rectal kit or Valtoco (nasal Diazepam)), administer 10 mg per rectum once as needed for seizure lasing greater than 3 minutes. See seizure protocol, if seizure continues for greater than 7 minutes after the first dose of Valtaco 10 mg, give Valtoco 5 mg intranasal. The second order indicated Diazepam 5 mg, take 5 mg per rectum as needed for seizure 7 minutes after 10 mg dose given. The POC further indicated there was no order for Magnesium Hydroxide, although P1's EMAR indicated an order to give Magnesium Hydroxide. During observation and interview on 11/2/22, at 11:30 a.m. licensed practical nurse (LPN)-B was observed looking in P1's room and stated P1 only had Diazepam 10 mg and 5 mg in the rectal form. LPN-B was unable to find a nasal form of Diazepam (Valtoco) and stated she was going to call the clinical director to get this clarified. During interview on 11/07/22, at 1:35 p.m. pharmacist from Olidia Pharmacy stated the only order in their system was dated in July 2022, which directed to give Diazepam 10 mg intranasal for seizure greater than 3 minutes, if greater than 7 minutes to give 5 mg intranasal. In an additional. During an interview that day at 4:00 p.m. the pharmacist stated they did find both the intranasal and the rectal form of the Diazepam in P1's home and the staff were going to discard the rectal form of the medication. During interview on 11/14/22, at 3:30 p.m. RN-E stated after reading the two orders for the Diazepam it was very confusing what she should be giving and will be calling the CD to have this clarified since she would have no idea what to give if P1 had seizure. The agency's Medication Management policy undated, indicated "All medication orders are reviewed for accuracy and completeness by the Clinical Supervisor/Case manager".

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure the plan of care (POC) included the patient psychosocial needs for 1 of 1 patient (P1) whose record was reviewed for attending school. P1’s plan of care POC for the certification period 9/01/22 through 10/31/22 indicated P1 was admitted to the home health agency (HHA) on 9/08/21, with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (condition that affects muscles and movement., by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated she received tube feeding with a ketogenic diet, and free water. The POC indicated P1 received private duty nursing 4-7 days a week, and the disciplines involved in providing care included, the main physician, school therapist, and teachers. P1's plan of care (POC) for the certification period 11/01/22 through 12/31/22, indicated P1 was admitted to the home health agency (HHA) on 9/08/21, with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (condition that affects muscles and movement., by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated she received tube feeding with a ketogenic diet, and free water. The POC indicated P1 received private duty nursing 4-7 days a week, and the disciplines involved in providing care included, the main physician, school therapist, and teachers. A report submitted to the State Agency (SA) on 10/26/22 indicated concern about P1's well-being and safety. The report indicated a concern for P1’s lack of school attendance, since it had now been two months into the school year and P1 had still not been able to attend school. In addition, the report indicated P1 did not attend school the entire 2021/2022 school year while living in the group home and it was crucial for her well-being and development she be with peers. During interview on 11/02/22, at 9:56 p.m. family member (FM)-A stated P1 had not been to school since she was admitted to the agency's home back on 9/08/21. FM-A stated she had been told by the clinical director (CD) they are always working on trying to get staff to take her to school but nothing seems to happen. FM-A stated she would really like P1 back in school and does not understand why she is not. The last thing she heard from the CD was the bus would be coming at 6:00 a.m. and none of the agency nurses were willing to work those hours to go with P1 to school. During interview on 11/03/22, at 10:00 a.m. CD stated P1 was receiving 24-hour nursing care at first and then in the last few months P1's hours were reduced to 16 hours a day, so they did not have enough nursing hours to send P1 to school. In addition, CD stated she thought FM-A met with the school and was working on sending P1 back to school but was not sure when and where things were at. The CD stated there was a time the bus was willing to pick up P1 at 6:00 a.m. and did not think none of the nurses would be willing to take P1 at that time. The CD was unable to provide any documentation on this. In addition, the CD stated she was just informed that P1 had been approved for 24-hour private duty nursing care and will try to find a nurse to take her to school. During interview on 11/4/22, at 11:30 a.m. registered nurse case manager (RNCM) from P1’s specialty healthcare clinic stated their medical team had been trying to get P1 back into school and nothing seems to be done to have this process to be completed. RNCM stated the healthcare team is very frustrated with the home health agency for trying to make this happen. A policy regarding psychosocial needs pertaining to the plan of care was requested but was not provided.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on the number and/or severity of the deficiencies cited the home health agency (HHA) failed to meet the Condition of Participation at 484.75, Skilled Professional Services. The agency failed to provide skilled professional services according to the plan of care approved by the medical provider for 3 of 3 patients (P1, P2, and P3) who had missed services. Refer to G710: The home health agency (HHA) failed to provide skilled professional services as indicated in the plan of care (POC) for 3 of 3 patients (P1, P2, and P3) reviewed for the POC. P1 had weight loss and missed medication, P2 and P3 lacked staff to provide cares and services.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and document review the home health agency (HHA) failed to provide skilled professional services as indicated in the plan of care (POC) for 3 of 3 patients (P1, P2, and P3) reviewed for the POC. P1 had weight loss and missed medication, P2 and P3 lacked staff to provide cares and services. P1’s plan of care POC for the certification period 9/01/22 through 10/31/22 indicated P1 was admitted to the home health agency on 9/8/21 with diagnoses of restrictive lung disease, tracheostomy, spastic quadriplegic cerebral palsy (condition that affects muscles and movement, by increased muscle tone and makes muscles stiff and movements jerky and awkward) and seizure disorder. The POC indicated she received tube feeding with a ketogenic diet, give 120 milliliters (ml) per hour (hr) until formula is completely gone. The POC indicated P1 received private duty nursing 4-7 days a week. In addition, the POC directed staff to put the patient up in a wheelchair twice daily at 11:00 a.m. and 6:00 a.m. using a Hoyer lift. P1 was to receive Sodium Chloride 0.9% (NS bolus) 1:1 replacement for ostomy output greater than 500 ml with 1:1 NS by G-tube, Magnesium Hydroxide (Milk of Magnesia 8%) take 3 ml by G-tube twice a day; however, P1’s magnesium increased to 4 ml on 9/21/22. Chlorthalidone (for high blood pressure) 25 milligrams (mg) via G-tube daily, Imodium A-D 2 mg tab via g-tube daily for loose stools, Felbamate (seizures) 600 mg one tablet via G-tube three times daily, Amantadine (symptoms of Parkinson's) 100 mg oral take 0.5 tablet via G-tube twice daily. A report submitted to the State Agency (SA), dated 10/26/22, indicated P1's "ongoing weight loss, [P1] has lost another 1.5 kg since her visit in July. She is now 37.9 kg. For reference, her weight was 45.9 kg 9/8/21 at the time of admission to Olidia Home Care Group Home. With this ongoing weight loss, we have requested daily documentation of her intake and output. Unfortunately, over the last 30 days, she has had documented input and output (I/O) for 15 of these days. On these days P1 had documented amounts of formula left in the morning ranging from 75-300 ml. Her tube feeds are written such that she should have 3 hours of time off the feeding pump and have 0 ml of formula left over. On average over the last month with documented I/O’s P1 has had 175 ml of formula left in the morning. We are concerned about the cause of her weight loss being related to the decreased intake of formula. A review of P1's Intake and Output from August 2022 to October 2022 indicated P1 had left over tube feeding formula (nutrition) at 8:00 a.m. when P1 should have 0 ml of formula left over totaling 3,810 ml of lost nutrition and P1 did not receive a replacement of 1:1 normal saline for any stool output over 500 ml during the 12-hour period totaling 6,390 ml of lost hydration. At 8:00 a.m. on the following days P1 had formula remaining, loss nutrition: 8/7/22 was 120 ml 8/8/22 was 60 ml 8/11/22 was 100 ml 8/15/22 was 110 ml 8/16/22 was 250 ml 9/10/22 was 180 ml 9/11/22 was 180 ml 9/12/22 was 130 ml 9/13/22 was 180 ml 9/16/22 was 100 ml 9/19/22 was 210 ml 9/20/22 was 160 ml 9/21/22 was 150 ml 9/22/22 was 50 ml 9/28/22 was 110 ml 9/29/22 was 300 ml 9/30/22 was 220 ml 10/1/22 was 20 ml 10/2/22 was 150 ml 10/3/22 was 220 ml 10/4/22 was 150 ml 10/5/22 was 180 ml 10/6/22 was 210 ml 10/8/22 was 110 ml 10/10/22 was 160 ml On the follow days P1 had stool output greater than 500 ml with no hydration replacement of normal saline. 8/7/22 was 745 ml 8/10/22 was 750 ml 8/11/22 was 580 ml 8/13/22 was 570 ml 9/12/22 was 525 ml 9/17/22 was 550 ml 9/19/22 was 700 ml 9/21/22 was 570 ml 9/22/22 was 550 ml 10/13/22 was 850 ml A review of P1's weight loss according to P1’s specialty healthcare clinic 4/13/22 to 10/26/22 indicated the following weight loss: 4/13/22: 43.3 kilograms (kg) = 95.0 pounds (lbs) 5/9/22: 39 kg = 85.9 lbs 6/6/22 38.2 kg = 88.1 lbs 7/6/22 40 kg = 88.1 lbs 7/20/22 39.4 kg = 86.8 lbs 10/26/22 37.9 kg = 83.5 lbs Total weight loss= 11.5 lbs During interview on 11/8/22, at 11:00 a.m. clinical director (CD) stated the staff was supposed to be providing saline when P1 had stools greater than 500 ml and they did not, in addition, the CD stated she was not sure why formula was left over at 8:00 a.m. unless the staff was unhooking the feeding for long periods of time during transfers. A review of P1's Medication Administration Record August 2022 through October 2022, indicated the following missed medications due to unavailability or missed: Magnesium Hydroxide was missed on 8/7/22, 8/15/22 at 6:00 am, and 6:00 p.m. was documented as “not available". Chlorthalidone documented as "not available": 9/24/22, 9/25/22, 9/28/22, 9/30/22, 10/05/22, 10/6/22, 10/08/22, 10/10/22, 10/12/22, 10/19/22, 10/20/22, 10/22/22, 10/23/22 and 10/27/22 Imodium documented as "not available" : 7/14/22, 8/3/22, 9/12/22, 9/15/22, 9/16/22, 9/17/22, 9/18/22, 9/21/22, 9/22/22, 9/24/22, 9/25/22 and 9/30/22. Felbamate was documented as "not available" on 10/5/22 and 10/6/22. Amantadine was documented as "medication not on hand" from 7/28/22 through 7/31/22. During an interview via email on 11/03/22, at 8:24 p.m. P1's physician from the specialty healthcare clinic she indicated concerns with P1 missing her medications and explained the following reasons for each medication via email message: Summary of these medication concerns: chlorthalidone - she is on this for prevention of further kidney stones (at risk and has developed these due to the keto diet) and progression of her osteopenia (progression of osteopenia Leads to increased fracture risk) Immodium - this is not typically concerning to miss but for the patient who struggles with a high-output ostomy, this is to limit ostomy output. With high outputs, she ended up in the hospital. Further, when she has high output this has correlated with weight loss which we are concerned about. Felbamate is one of her seizure drugs. Missing this can cause seizures. Amantadine is a medication for her movement disorder. Missing this can cause her movement disorder to be increased which can put her at risk of injury by striking something with her arms as well as increase her caloric needs. We do worry when her movements are not well controlled she can lose weight. Magnesium hydroxide is to ensure she is meeting her dietary needs of magnesium as without this she has been deficient. In reviewing labs she has had low magnesium levels. This is important for bone health and if chronically low can contribute to osteoporosis. During interview on 11/07/22, at 1:40 p.m. pharmacist from Olidia Pharmacy stated the pharmacy was not made aware of these medications were out. The pharmacist further stated, "the staff at the home are supposed to call one week in advance to notify them when the medications are due to be refilled so they don't run out". During observation and interview on 11/02/22, at 11:30 a.m. P1 was observed to be lying in bed. LPN-B stated the other staff member in the home had to take another patient to an appointment and she was the only staff member in the home and was unable to get P1 up with a Hoyer lift by herself. During observation and interview on 11/07/22, at 11:08 a.m. P1 was observed to be in bed. RN-E stated she was in the home alone today due to a nurse calling in and P1 required assist of two with the Hoyer lift she would be unable to get her up. P2's plan of care (POC) for the certification period 9/23/22, through 11/22/22, indicated P2 was admitted to the home health agency on 5/25/22, was alert and orientated with diagnoses of acute hypoxemic and hypercarbaric (increased carbon dioxide in the bloodstream) respiratory failure requiring endotracheal intubation (placement of a flexible plastic tube into the trachea to maintain an open airway), status post-extubation and Duchenne muscular dystrophy (wasting of the muscles) and pressure ulcer. In addition, the POC indicated P2 required the assistance of two and a Hoyer lift for transfers, total assistance for dressing and grooming, and always wears a brief but is continent of bowel and bladder and used a commode for bowel movements. The POC indicated P2 had a ventilator, tube feeding and was to receive 8 to 24 hours of complex private duty nursing for 5 to 7 days a week for 356 days a year for monitoring and supervision. During interview on 11/03/22, at 10:00 a.m. FM-B stated P2 had no staff care for him from 6:00 a.m. until 9:30 a.m. and his new call light had stopped working. In addition, FM-A stated P2 called him and informed him he was incontinent of bowel, which he rarely has and was upset about, and usually would ask to use a commode but there was no staff available to help him. In addition, FM-B stated P2 was supposed to go to a doctor's appointment today and missed his appointment due to the nurse arriving late. During interview on 11/03/22, at 10:14 a.m. registered nurse (RN)-D clinical nurse manager for P2 stated the nurse for P2 did not show up for the home and P2 did not receive care from 6:00 a.m. until she went into his room at 9:30 a.m. to provide cares. RN-D stated P2 was incontinent of bowel and required a change. In addition, RN-D stated P2 did miss his appointment because the driver arrived at the home at 9:00 a.m. P2 was still in bed not dressed and not ready for his appointment. The nurse was not at the home to go with P2, and the driver waited 30 minutes and had to leave without taking P2 to his appointment. P3's plan of care (POC) for the certification period 9/03/22 through 11/02/22 indicated that P3 had diagnoses of epilepsy, a history of urinary tract infections, chromosome abnormalities, incontinent of bowel incontinence and bladder and received tube feeding. P3's POC indicated he received 6-24 hours of complex private duty nursing 3-7 days a week to observe and assess P3’s cardiac status, respiratory status, gastrointestinal status, and neurological status. In addition, the POC directed staff to get P3 up in a wheelchair (WC) or specialty recliner daily as needed but no longer than two hours, use the Hoyer lift and assist two. The POC also directed staff to assess skin after getting out of the WC or recliner and report any asking conditions to the case manager. The POC indicated to get P3 up at 5:00 p.m. and back down at 7:00 p.m. During observation and interview on 11/02/22, at 11:45 a.m. P3 was observed to be in the living room of his home sitting up in his wheelchair. P3 was yelling (unable to understand words) and constantly squirming in his wheelchair, flailing his legs. LPN-B would attempt to calm him by putting cartoons on the television with no improvement in his yelling and movement in his wheelchair. LPN-B stated for some reason P3's school bus did not arrive that day to pick him up for school, so he is home today, and she is the only nurse in the home until the other nurse returns from taking another patient to a medical appointment. LPN-B stated P3 had been up in his wheelchair from approximately 8:00 a.m. and was not sure when the other nurse will return so she can put P3 back into bed to reposition and change him. During interview on 11/03/33, at 1:00 p.m. clinical director (CD) stated the other nurse returned on 11/02/22, at 2:00 p.m., and then P3 was able to be put back into bed. The CD stated when this happens, they would usually try to have a personal care attendant (PCA) come to the home to help with transfers but was not aware LPN-B was alone in the home that day. The CD did not think P3 had any skin breakdown from being left sitting up in his w/c for six hours. Facility policy on services provided in the plan of care was requested but was not received.

On 8/25/22 – 8/30/22 a complaint survey was conducted. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. H81544313C/71575 was substantiated deficiencies were issued at G436, G572, G608, and G612 as a result of the complaint investigation.

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 interview and document review the facility failed to ensure all services outlined in the plan of care were implemented on 1 of 3 patient (P1) as assessed for cares provided when the facility had missed shifts of cares and did not ensure that the family was fully trained on all care areas of the care plan or if cares were completed. In addition, documentation on clinical nursing notes did not indicate all cares were completed when agency staff was caring for P1. P1 was identified as new a tracheostomy and ventilator patient following a complicated hospital stay for Covid-19 and bacterial pneumonia with respiratory failure needing a ventilator long term and tube feedings through a gastrostomy tube newly placed. P1 was a quadriplegic, he used an indwelling foley catheter and suffered from skin altercations. P1s Home Health Certification and Plan of Care dated (POC) 8/18/22 to 10/17/22, indicated P1’s start of care was 8/18/22. P1’s diagnosis included of acute respiratory failure, ventilator dependent (needed ventilator at all times), surgical procedure of gastrostomy. The POC indicated P1 received skilled nurse visits for treatments including indicated daily treatments were needed for: 1. Urostomy care, right abdomen drain checked and emptied every 4 hours and as needed. 2. Change urostomy dressing daily and as needed. 3. Ventilator support and vent setting checks every shift. 4. Toileting, turning and repositioning every 2 hours as needed. 5. Bathing assistance twice daily and as needed. 6. As needed transfer patient is an assist of 2 for transfer with a Hoyer lift every shift and as needed. 7. Trach cares cleanse with sterile water and hydrogen peroxide twice a day, change split gauze twice daily and as needed. 8. G/J-tube cares, client has a gastrojejunostomy, cleanse with soap and water twice daily, change split gauze twice daily and as needed. 9. Flush catheter tube with 100 milliliters normal saline every shift. 10. Sacral wound cleanse with soap and water and change foal dressing as needed. 11. Suction every 4 hours and as needed. 12. Vital signs every shift. 13. Assess heart rate and breath sounds. Assess signs and symptoms of respiratory distress. Medication administration and treatments: 1. Tube feeding Isosource 1.5 run at 30 ml/hr. continuously via Gtube. 2. 2 acetylcysteine 20% 200 mg/ml nebulizer inhale 2 ml in nebulizer three times a day. Albuterol 0.083% nebulizer solution, inhale 1 vial via nebulizer every 6 hours as needed for cough or shortness of breath. 3. Other oral medications administered through g-tube daily as ordered. 4. Bisacodyl suppository Monday, Wednesday, and Friday. The orders for nursing were, 12-24 hours complex private duty nurse for 365/day/year monitoring and supervision, and accessibility to skilled nursing services by private duty nursing personnel. Admission Assessment – Skin dated 8/18/22, indicated skin care as ordered, clean, give bed bath as scheduled, open area treatment as ordered. Nursing to assess/monitor peri-area with all incontinence product changes and apply ordered creams as necessary. Monitor and assess for all signs and symptoms of skin breakdown. Assess skin integrity and pressure points continuously. Wound care Right abdomen – abrasion – cleanse with normal saline, apply skin prep around wound. Change PRN (as needed) soilage, dislodgement, signs of infection, PRN sacral and coccyx wound care. Cleanse with bath wipe. Tracheostomy and G-tube site care. Clinical Nursing Note start date and time of 8/19/22 at 7:00 a.m. with an end date and time 8/19/22 at 11:59 p.m. indicated LPN-B worked a 17-hour shift. The nursing note did not indicate that bathes, Gtube dressing change and site care, trach site dressing change, and wound care were provided. The nursing note does provide an area for repositioning documentation. Clinical Nursing Note start date and time of 8/20/22 at 12:00 a.m. with an end date and time 8/20/22 at 4:00 a.m. indicated LPN-B worked a 4-hour shift. The nursing note did not indicate that bathes, Gtube dressing change and site care, trach site dressing change, and wound care were provided. The nursing note does provide an area for repositioning documentation. The focus-data-action-response indicated LPN-B ensured safety and good ventilation, P1 was vent dependent, P1 was suctioned and was watched, the client was stable with no concerns. There was no documentation regarding the reason P1 was sent to the hospital at 4:00 a.m. Clinical Nursing Note start date and time of 8/22/22 at 7:00 p.m. with an end date and time 8/23/22 at 7:00 a.m. indicated RN-B worked a 12-hour shift. RN-B documented P1 had a skin tear, and aseptic and sterile technique wound care was provided. The note does not indicate any specifics around the skin tear, wound. The note does not indicate that bathing, G-tube care, catheter cares, ostomy bag or repositioning cares were completed. Clinical Nursing Note start date and time of 8/23/22 at 7:00 a.m. with an end date and time 8/23/22 at 7:00 p.m. indicated RN-C worked at 12-hour shift. RN-C indicated no skin concerns. The note does not indicate bathing, tracheostomy cares, Gtube cares or catheter cares were provided. Upon interview on 8/25/22 at 1:19 p.m. RN-A, the clinical manager, indicated she was not sure what happened the other night 8/20/22 when P1 was taken to the hospital, there was something wrong with the balloon not inflating properly. RN-A indicated when P1 returned they did not have a nurse for him and family needed to step in. Upon interview on 8/26/22 at 3:44 p.m. RN-A, the clinical manager verified that P1 was not seen by the agency from 8/20/22 7:00 a.m. until 8/22/22 7:00 p.m. as there was no agency staff in the home. RN-A was not certain if a family assisted him with cares or if cares were received which family member assisted him. She verified that she is aware some family members assist him and not been trained by the agency yet. RN-A reported that each week, the nursing staff was to check the Medication Administration Record (MAR) and Treatment Administration Record to see if the family had been providing cares. Family was unaware they were supposed to be filling out any care forms for the agency and there was no documentation on when a facility nurse was to checking cares provided by the family A facility policy was requested related to plan of care services, however none received.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based interview and record the facility failed to notify the physician when the HHA missed scheduled visits, treatments, and services as required by the plan of care for 1 or 1 patient, P1 reviewed for plan of care. There were no nursing staff to cover shifts from 8/20/22 at 7:00 a.m. to 8/22/22 at 7:00 p.m. P1 was identified as new a tracheostomy and ventilator patient following a complicated hospital stay for Covid-19 and bacterial pneumonia with respiratory failure needing a ventilator long term and tube feedings through a gastrostomy tube newly placed. P1 was a quadriplegic, he used an indwelling foley catheter and suffered from skin altercations. P1’s Service Agreement dated 8/18/22, indicated the agency will provide private nursing for the hours the patient is on the ventilator. The agency will provide private duty nursing for all hours that the patient has a tracheostomy. P1s Home Health Certification and Plan of Care dated (POC) 8/18/22 to 10/17/22, indicated P1’s start of care was 8/18/22. P1’s diagnosis included of acute respiratory failure, ventilator dependent (needed ventilator at all times), surgical procedure of gastrostomy. The POC indicated P1 received skilled nurse visits for treatments including indicated daily treatments were needed for: 1. Urostomy care, right abdomen drain checked and emptied every 4 hours and as needed. 2. Change urostomy dressing daily and as needed. 3. Ventilator support and vent setting checks every shift. 4. Toileting, turning and repositioning every 2 hours as needed. 5. Bathing assistance twice daily and as needed. 6. As needed transfer patient is an assist of 2 for transfer with a Hoyer lift every shift and as needed. 7. Trach cares cleanse with sterile water and hydrogen peroxide twice a day, change split gauze twice daily and as needed. 8. G/J-tube cares, client has a gastrojejunostomy, cleanse with soap and water twice daily, change split gauze twice daily and as needed. 9. Flush catheter tube with 100 milliliters normal saline every shift. 10. Sacral wound cleanse with soap and water and change foal dressing as needed. 11. Suction every 4 hours and as needed. 12. Vital signs every shift. 13. Assess heart rate and breath sounds. Assess signs and symptoms of respiratory distress. Medication administration and treatments: 1. Tube feeding Isosource 1.5 run at 30 ml/hr. continuously via Gtube. 2. 2 acetylcysteine 20% 200 mg/ml nebulizer inhale 2 ml in nebulizer three times a day. Albuterol 0.083% nebulizer solution, inhale 1 vial via nebulizer every 6 hours as needed for cough or shortness of breath. 3. Other oral medications administered through g-tube daily as ordered. 4. Bisacodyl suppository Monday, Wednesday, and Friday. The orders for nursing were, 12-24 hours complex private duty nurse for 365/day/year monitoring and supervision, and accessibility to skilled nursing services by private duty nursing personnel. Upon interview on 8/25/22 at 3:52 Family (FA)-A stated the family is certainly able to help, but the agency left P1 without care from 8/20/22 at 7:00 a.m. until 8/22/22 at 7:00 p.m. She stated the family made multiple attempts to call the agency but no response from the facility until a nurse came to a shift on 8/22/22, at 7:00 p.m. “This is not what we expected, this is not what we signed up for, the physician at the hospital said he had to have 24-hour care. How can they write 12-24 on the form?” FA-A explained that the facility did not notify the family that P1 would not be receiving cares from 8/20/22 at 7:00 a.m. through 8/22/22 at 7:00 p.m. The family made multiple calls to the agency to see when the next nurse would be coming with no call returned. P1 had gone to the hospital on 8/20/22 from 4:00 a.m. to 7:00 a.m. for shortness of breath. Upon interview on 8/26/22, at 2:48 p.m. the hospital care manager stated that the hospital was under the impression that the patient was being cared for 24 hours a day and an hour here and there for breaks or shift change. She stated the hospital called many agencies to find one who could honor a ventilator dependent patient for 24-hours. This agency was chosen after a discussion with RN-A, the clinical manager at the agency stated on 8/9/22 that in order to admit P1 the family will need training at the hospital on the ventilator care if there is an hour or so gap of care in the case of an emergency. This was an absolute need that needed to be place, the hospital understood the cares to be 24 hours a day and the family be prepared for an emergency, not do entire shifts of care. She stated the facility did not communicate that the family would be doing cares with the hospital. There was note in the hospital chart that the facility had missed three consecutive shifts from the family, but no notes that the agency called for direction on the missed visits. Upon interview on 8/26/22, at 3:44 p.m. RN-A, the clinical manager verified the visits from 8/20/22 at 7:00 a.m. until 8/22/22 at 7:00 p.m. were missed. She stated he is a new patient, and they staff show-up to their assigned shift with P1. She stated once a schedule gets going this won’t happen again. She verified that the physician was not notified of the missed visits. Upon interview on 8/29/22, at 12:21 P1’s Pulmonologist reported that in this case the ventilator is new to the patient, and he does not feel the family is adequately trained to have a comfort level with the complex cares of P1. He reported he was under the impression that the facility would only an hour here and there and family just needed to know what to do in an emergency situation. He was not informed any visits had been missed by the agency. A facility policy was requested, however none provided.

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 interview and document review, the facility failed to coordinate care with family to meet a patient’s 24-hour care needs for 1 of 1 patient, P1, reviewed for coordination of care when nursing staff were not providing 24-hour care and nursing staff did not show up for multiple shifts. P1 was identified as new a tracheostomy and ventilator patient following a complicated hospital stay for Covid-19 and bacterial pneumonia with respiratory failure needing a ventilator long term and tube feedings through a gastrostomy tube newly placed. P1 was a quadriplegic, he used an indwelling foley catheter and suffered from skin altercations. This practice left family uncertain of the cares they needed to provide for P1. P1s Home Health Certification and Plan of Care dated (POC) 8/18/22 to 10/17/22, indicated P1’s start of care was 8/18/22. P1’s diagnosis included of acute respiratory failure, ventilator dependent (needed ventilator at all times), surgical procedure of gastrostomy. The POC indicated P1 received skilled nurse visits for treatments including indicated daily treatments were needed for: 1. Urostomy care, right abdomen drain checked and emptied every 4 hours and as needed. 2. Change urostomy dressing daily and as needed. 3. Ventilator support and vent setting checks every shift. 4. Toileting, turning and repositioning every 2 hours as needed. 5. Bathing assistance twice daily and as needed. 6. As needed transfer patient is an assist of 2 for transfer with a Hoyer lift every shift and as needed. 7. Trach cares cleanse with sterile water and hydrogen peroxide twice a day, change split gauze twice daily and as needed. 8. G/J-tube cares, client has a gastrojejunostomy, cleanse with soap and water twice daily, change split gauze twice daily and as needed. 9. Flush catheter tube with 100 milliliters normal saline every shift. 10. Sacral wound cleanse with soap and water and change foal dressing as needed. 11. Suction every 4 hours and as needed. 12. Vital signs every shift. 13. Assess heart rate and breath sounds. Assess signs and symptoms of respiratory distress. Medication administration and treatments: 1. Tube feeding Isosource 1.5 run at 30 ml/hr. continuously via Gtube. 2. 2 acetylcysteine 20% 200 mg/ml nebulizer inhale 2 ml in nebulizer three times a day. Albuterol 0.083% nebulizer solution, inhale 1 vial via nebulizer every 6 hours as needed for cough or shortness of breath. 3. Other oral medications administered through g-tube daily as ordered. 4. Bisacodyl suppository Monday, Wednesday, and Friday. The orders for nursing were, 12-24 hours complex private duty nurse for 365/day/year monitoring and supervision, and accessibility to skilled nursing services by private duty nursing personnel. P1’s Service Agreement was signed on 8/18/22, indicated the facility will provide private duty nursing during the hours that the client will spend on the ventilator and the agency will provide private duty nursing all hours that the client has a tracheostomy. The number of services or visits: The agency will provide average of 12-24 hours of nursing care a day up to 7 days a week. The Frequency of the services was indicated as daily. The Service agreement did not indicate any specific days or hours and did not indicate specifically when family was to assist. Client education signed on 8/18/22, indicated 2 family members were trained on: 1. Home safety. 2. Infection prevention. 3. Ventilator/Tracheostomy care of equipment. 4. Suctioning. 5. Emergency bag and bedside stock. 6. Resuscitation bag. 7. Tracheostomy Care. 8. Oxygen. 9. Auscultation of breath sounds. 10. Gastrointestinal/genitourinary system management. 11. Medication administration. The education does indicate education for the wound care, catheter flushing or urostomy care and urostomy dressing change. Upon interview with on 8/25/22, at 3:52 p.m. family member (FA)-A reported that the family is willing to help but has asking the facility since the admission on 8/18/22 for a schedule in the home and a plan of what the family is to do. Two family members have gone through ventilator training, but there 5-6 family members who assist and if the family is going to provide 12-hour shifts, more family members need to be trained. She stated, “We don’t know when they are coming and what they have when they are here, and we have asked for a schedule and things the family can specifically do.” FA-A stated the physician at the hospital told us P1 needed to have 24-hour care and we don't understand how the agency can expect that P1 only needs 12-hour skilled nursing care. FA-A explained that the facility did not notify the family that P1 would not be receiving cares from 8/20/22 at 7:00 a.m. through 8/22/22 at 7:00 p.m. The family made multiple calls to the agency to see when the next nurse would be coming with no call returned. P1 had gone to the hospital on 8/20/22 from 4:00 a.m. to 7:00 a.m. for shortness of breath. Upon interview on 8/26/22, at 2:46 p.m. registered nurse (RN)-A the clinical manager reported the agency team was meeting to get a concrete schedule in place for the family and the family has a Medication Administration Record and a Treatment Administration Record and should work from those forms when the agency is not there. She reported this was communicated verbally with the family. There was no documentation of the communication provided. A facility policy was requested regarding corrdination of care, however none was provided.

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 facility failed to provide written instructions to the patient and family of the agency skilled nursing schedule, all forms signed on the admission, including the bill of rights, the service agreement, and the family education forms for 1of 1 patient, (P1) reviewed for coordination of care. There was lack of clear communication between the agency, and P1 and P1's representatives for services provided by the agency. P1s Home Health Certification and Plan of Care dated (POC) 8/18/22 to 10/17/22, indicated P1’s start of care was 8/18/22. P1’s diagnosis included of acute respiratory failure, ventilator dependent (needed ventilator at all times), surgical procedure of gastrostomy. The POC indicated P1 received skilled nurse visits for treatments including indicated daily treatments were needed for: 1. Urostomy care, right abdomen drain checked and emptied every 4 hours and as needed. 2. Change urostomy dressing daily and as needed. 3. Ventilator support and vent setting checks every shift. 4. Toileting, turning and repositioning every 2 hours as needed. 5. Bathing assistance twice daily and as needed. 6. As needed transfer patient is an assist of 2 for transfer with a Hoyer lift every shift and as needed. 7. Trach cares cleanse with sterile water and hydrogen peroxide twice a day, change split gauze twice daily and as needed. 8. G/J-tube cares, client has a gastrojejunostomy, cleanse with soap and water twice daily, change split gauze twice daily and as needed. 9. Flush catheter tube with 100 milliliters normal saline every shift. 10. Sacral wound cleanse with soap and water and change foal dressing as needed. 11. Suction every 4 hours and as needed. 12. Vital signs every shift. 13. Assess heart rate and breath sounds. Assess signs and symptoms of respiratory distress. Medication administration and treatments: 1. Tube feeding Isosource 1.5 run at 30 ml/hr. continuously via Gtube. 2. 2 acetylcysteine 20% 200 mg/ml nebulizer inhale 2 ml in nebulizer three times a day. Albuterol 0.083% nebulizer solution, inhale 1 vial via nebulizer every 6 hours as needed for cough or shortness of breath. 3. Other oral medications administered through g-tube daily as ordered. 4. Bisacodyl suppository Monday, Wednesday, and Friday. The orders for nursing were, 12-24 hours complex private duty nurse for 365/day/year monitoring and supervision, and accessibility to skilled nursing services by private duty nursing personnel. P1’s Service Agreement was signed on 8/18/22, indicated the facility will provide private duty nursing during the hours that the client will spend on the ventilator and the agency will provide private duty nursing all hours that the client has a tracheostomy. The number of services or visits: The agency will provide average of 12-24 hours of nursing care a day up to 7 days a week. The Frequency of the services was indicated as daily. The Service agreement did not indicate any specific days or hours and did not indicate specifically when family was to assist. Upon interview on 8/25/22, at 2:17 LPN-A reported that the only forms in the home was an unsigned Home Health Certification and Plan of Care (485) form dated 8/18/22. The form indicated all medications and treatments the agency would be doing. There was also a Medication Administration Record (MAR) and Treatment Administration Record (TAR) printed in hard copy in the home. Upon interview on 8/25/22, at 2:52 p.m. Family (FA) reported that the family had not received a schedule from the agency or any of the forms the wife had signed upon admission. She stated she specifically wanted the service agreement. FA-A stated “The family isn’t sure what we should be doing and when.” Upon interview on 8/26/22, at 3:44 p.m. RN-A stated the only forms in the family’s home was the Home Health Certification and Plan of Care (485), the MAR and TAR. She stated the schedule was in process and will be delivered and the Service Agreement and all other signed forms will be delivered soon to the family The facility policy was requested regarding patient caregiver instructions, however none was provided.

On 7/13/22 through 7/15/22, a complaint survey was conducted. This resulted in a partial extended survey at Olidia Home Care. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. H81543173C/71136 was unsubstantiated, although deficiencies were issued at G482, G488, and G716 as a result of the complaint investigation.

Mistreatment, neglect or abuse CFR(s): 484.50(e)(1)(i)(B) (i)(B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to investigate an allegation of neglect for 1 of 1 patient (P1), following a fall that resulted in a head injury when licensed practical nurse (LPN)-A was providing incontinent care and P1 rolled out of bed. P1 was hospitalized and expired from multiple medical complications. P1's Home Health Certification and Plan of Care (POC) for the certification period 6/02/22 - 8/02/22, indicated P1 was a patient with a complex medical history of C4-C5 incomplete spinal cord injury resulting quadriplegia, acute and chronic respiratory failure, hypoxia (low oxygen), and quadriplegia with spinal cord injury with a tracheostomy. The POC further indicated P1 received registered nurse (RN), licensed practical nurse (LPN) private duty nursing (PDN) 4-7 times a week for tracheostomy care, G-tube care, turning and repositioning every 1-2 hours, Foley catheter care, P1 was incontinent and the nurse to check and change every 2 hours, medication administration, vital signs, and skin assessments. P1 required total assistance for all cares. A report to the state agency dated 7/09/22, at 5:05 p.m. indicated on 7/09/22, at approximately 12:31 a.m. while LPN-A was on duty during a bowel change P1 fell face down from the bed to the floor. The report indicated 911 was called and the patient was taken to the hospital. The agency investigation indicated the following: A Fall Scene Investigation was completed undated, which indicated the patient was unresponsive, and there was slight blood on his head. The investigation further indicated P1 fell out of bed during care. The wife called the case manager in the next day on 7/09/22, to report the incident. In an interview with the staff involved, she stated that she was putting a "Chucks" (waterproof disposable absorbent pad) under P1 and turned him slightly when he fell out of bed unexpectedly. There was slight blood on his head, still responsive, and was taken to the emergency room (ER) by the emergency medical system (EMS) about five minutes after the incident. The Fall Scene Investigation further indicated P1 was asleep when staff heard a bowel movement staff initiated a toileting procedure and the patient had a fall during the process. The investigation indicated a phone call was made to P1's physician on 7/9/22, and fax was also sent at 12:28 p.m. The hospital discharge summary dated 7/11/22 indicated P1 was admitted on 7/9/22 and expired on 7/11/22 with the injuries to the brain, subarachnoid hematoma, lumbar fractures, and complications from hypoxic and hypercarbic respiratory failure, aspiration pneumonitis, acute respiratory distress syndrome, septic shock, A-fib, shock liver, and acute kidney injury. P1's CT scan did not explain P1's depressed mental status as the subarachnoid hematoma was stable. P1 was hemodynamically unstable with critical care issues as probable aspiration - pneumonitis and acute kidney injury. During interview on 7/13/22, at 10:15 a.m. with the clinical director (CD) stated she was informed of the incident the following morning of the incident on 7/9/22. The CD stated the LPN-A was cleaning P1 in bed after a bowel movement, she was turning him, and he had fallen out of bed in a prone position with his head bleeding. P1's wife was present in the home sleeping and LPN-A woke her when P1 fell. The paramedics were called and P1 was sent to the hospital. Once in the hospital, he was diagnosed with a subarachnoid hematoma (brain bleed). During interview on 7/14/22, at 11:00 a.m. the 3 West hospital nurse manager (NM) stated P1 did have a subarachnoid hemorrhage when he fell and hit his head, the injury was very minimal according to what the physicians told her. The physicians at the hospital did not feel that was the main reason for his illness. The NM stated when he arrived at the hospital, he was very septic from infection and his wife had decided to put P1 on comfort care and he passed away in our unit. During interview on 7/14/22, at 1:00 p.m. with P1’s family member (FM)-A, she stated that LPN-A had worked with P1 for many years. FM-A stated LPN-A yelled for help when P1 fell, LPN-A was cleaning P1 after a bowel movement, which was unusual for P1 to have a bowel movement at night. FM-A stated that when at the hospital with P1, the doctor indicated the subarachnoid bleed was small and there was no reason for surgery. The hospital thought Pneumonitis, but his secretions were fine as he had IV antibiotics three weeks ago. The investigation lacked any interview with P1's family member, to indicate if she had any concerns with LPN-A, P1's location at the time of the fall, the extent of injuries, or any other environmental concerns during the fall. Facility Abuse and Neglect Training dated 2/12/2018, indicated "The complaint investigation shall commence within 48 hours of receipt of the written report complaint." In addition, the procedure indicated the director of Patient Care Services is responsible for investigating all patients."

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to immediately report an allegation of neglect for 1 of 1 patient (P1), following a fall that resulted in a head injury when licensed practical nurse (LPN)-A was providing incontinent care and P1 rolled out of bed. P1 was hospitalized and expired from multiple medical complications. P1's Home Health Certification and Plan of Care (POC) for the certification period 6/02/22 - 8/02/22, indicated P1 was a patient with a complex medical history of C4-C5 incomplete spinal cord injury resulting quadriplegia, acute and chronic respiratory failure, hypoxia (low oxygen), and quadriplegia with spinal cord injury with a tracheostomy. The POC further indicated P1 received registered nurse (RN), licensed practical nurse (LPN) private duty nursing (PDN) 4-7 times a week for tracheostomy care, G-tube care, turning and repositioning every 1-2 hours, Foley catheter care, P1 was incontinent and the nurse to check and change every 2 hours, medication administration, vital signs, and skin assessments. P1 required total assistance for all cares. A report to the state agency dated 7/09/22, at 5:05 p.m. indicated on 7/09/22, at approximately 12:31 a.m. while LPN-A was on duty during a bowel change P1 fell face down from the bed to the floor. The report further indicated 911 was called and the patient was taken to the hospital. During interview on 7/13/22, at 10:15 a.m. with the clinical director (CD) stated she was informed of the incident the following morning of the incident on 7/9/22. The CD stated the LPN-A was cleaning P1 in bed after a bowel movement, she was turning him, and he had fallen out of bed in a prone position with his head bleeding. P1's wife was present in the home sleeping and LPN-A woke her when P1 fell. The paramedics were called and P1 was sent to the hospital. Once in the hospital, he was diagnosed with a subarachnoid hematoma (brain bleed).The CD stated LPN-A did not inform her of the incident immediately according to policy and the agency was informed of the incident by P1's wife the following morning. Facility Abuse And Neglect Training dated 2/12/2018, indicated when to report: "Immediately make a report when you have reasonable cause to believe that abuse, abandonment, neglect, or financial exploration occurred to a vulnerable adult."

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to provide an accurate assessment for 1 or 1 patient (P1) when licensed practical nurse (LPN)-A entered clinical nursing notes for P1 several times prior to the start of her shift in advance of providing care to P1. P1's Home Health Certification and Plan of Care (POC) for the certification period 6/02/22 - 8/02/22, indicated P1 was a patient with a complex medical history of C4-C5 incomplete spinal cord injury resulting quadriplegia, acute and chronic respiratory failure, hypoxia (low oxygen), and quadriplegia with spinal cord injury with a tracheostomy. The POC further indicated P1 received registered nurse (RN), licensed practical nurse (LPN) private duty nursing (PDN) 4-7 times a week for tracheostomy care, G-tube care, turning and repositioning every 1-2 hours, Foley catheter care, P1 was incontinent and the nurse to check and change every 2 hours, medication administration, vital signs, and skin assessments. P1 required total assistance for all cares. A report to the state agency dated 7/09/22, at 5:05 p.m. indicated on 7/09/22, at approximately 12:31 a.m. while LPN-A was on duty during a bowel change P1 fell face down from the bed to the floor. The report further indicated 911 was called and the patient was taken to the hospital. The following inconsistencies were found after an audit was conducted by the CD on LPN-A's documentation was submitted other than the location of P1's home and/or submitted prior to care of P1: 5/7/22-submitted from Rockford 5/8/22-submitted from Shakopee 5/12/22-submitted from Shakopee 5/13/22- submitted from Shakopee 5/21/22- submitted from St Croix St Park 5/22/22- submitted from St Croix St Park 6/1/22 - submitted from Minneapolis 6/5/22 - submitted from Bloomington 6/11/22 - submitted from Arden Hills from P1's home although submitted in advance on 6/10/22. 6/24/22 - submitted from Arden Hills P1's home, submitted in advance on 6/23/22. 7/1/22- submitted from Hinkley 7/2/22- submitted from Hinkley 7/7/22- submitted from Hinkley and in advance to start of shift on 7/7/22. 7/8/22 -submitted from Hinkley and in advance to start of shift on 7/7/22. Further review of LPN-A's Clinical Nursing notes identified the following on her assessments: - from 5/7/22 to 5/13/22, LPN-A's Clinical Nursing Notes when LPN-A worked had the identical assessment information for vital signs, musculoskeletal, respiratory, eye nose and throat, skin condition, cardiovascular, gastrointestinal, genitourinary, endocrine, neurological, and services provided (catheter care, trach care). -from 5/27 to 6/11/22 same finding was found as above. -from 6/11/22 to 7/9/22 same finding was found as above. During an interview on 7/15/22, at 1:00 p.m. the clinical director (CD) stated when reviewing LPN-A's clinical notes from the date of P1's fall on 7/9/22, it was noted LPN-A had completed her Clinical Note on 7/7/22, and the note was submitted from Hinkley, MN not from Arden Hills, MN where P1's home was located. The CD stated she was unaware LPN-A was submitting her clinical nursing notes outside the patient's home and in advance. The CD stated that it is against their agency policy to be doing this and there is no way the clinical nursing notes can be accurate if done in advance. The CD stated the case manager saw P1 on the opposite days of LPN-A and all her visits showed submissions from P1's home. During an interview on 7/15/22, at 1:15 p.m. the agency administrator stated he helped create the computer program the nurses document on and they set it up, so they know when the nurses are clocking in and where they are submitting their assessments. The administrator stated the nurses are expected to submit their data from the patient's home and had no idea LPN-A was submitting elsewhere. The administrator stated their system is accurate in the location of the submission and the dates submitted. The administrator stated he had concerns with LPN-A's clinical nursing notes from looking at her last several visits, which indicated P1's temperature was 98.0 and felt there should have been changes or fluctuations since when the case manager worked, she had different temperatures documented. During interview on 7/15/22, at 1:31 p.m. LPN-A stated she completes her clinical nursing notes with her own computer tablet. LPN-A stated the agency does have a computer at the home but preferred to use her own. LPN-A stated she did complete her clinical nursing notes on 7/7/22, in advance for 7/8/22 because she had been so busy and thought if she needed to, she could go back and make changes to her clinical nursing notes if anything changed. LPN-A stated that was the first and only time she had documented in advance. LPN-A stated she had no idea why her submission data is indicating submissions from other locations than the patient's home. LPN-A had no comment on her clinical nursing notes assessment data that has identical information for multiple days in a row. The agency's Information Management Policies and Training undated, indicated Olidia has an electronic medical record system developed and deployed to comply with state and federal electronic visit verification requirements. To comply with the law, caregivers are required to clock in, clock out, and submit their SHIFT NOTES within 1000 feet of the client care area. Shift notes include Medication Administration Records, Treatment Records, Clinical Notes, Nursing Flow Sheets, and Skilled Nursing Visit Notes.

On 6/14/22-6/17/22, a complaint survey was conducted. This resulted in a standard survey at Olidia Care, Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. H81542150C/70791 was substantiated, a deficiency was issued at G564 as a result of the complaint investigation.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on interview and document review the home health agency (HHA) failed to provide all necessary medical information, to emergency medical services (EMS) for 1 of 1 patient (P1) reviewed for discharge and transfer. P1's current plan of care (POC) for certification period 6/5/22 through 8/4/22, signed by physician on 6/14/22, indicated P1’s diagnoses included acute respiratory failure with hypoxia, tracheostomy dependent, lung disease, cerebral palsy (CP), seizures, agitation, and developmental academic disorders. The POC indicated P1 received 24 hours complex registered nurse (RN)/licensed practical nurse (LPN)/private duty nursing (PDN) 3 to 7 days a week for all medical cares that included trachea cares, maintain patent airway, maintain skin integrity and enteral nutrition. P1’s North Memorial Pre-Hospital Care Report dated 06/05/2022, included “Patient is physiologically/psychologically impaired, non-ambulatory, (bed bound) and non-verbal.” It further included under the heading titled “Current Medications” unable to complete. P1’s hospital discharge paperwork dated 6/8/22, included P1 “was nonverbal and unable to provide history. Attempted to call group home, unable to leave voicemail.” During an interview on 6/15/22, at 3:52 p.m. paramedic (P)-A stated the reason he had received an emergency 911 call to P1’s home on 6/5/22 was because the patient’s oxygen saturation (O2) levels were in the 80 % range and the patient was vomiting. P-A stated upon arrival, P1 was in bed with only an incontinent brief on, his oxygen was off, and it looked as if registered nurse (RN)-A had just suctioned him. P-A stated RN-A was unable to tell him what P1’s diagnoses were, what medications he had given him, or what P1’s allergies were. P-A stated, “to this day, I still don’t know what his underlying condition was.” P-A stated he asked RN-A for a medication list, but RN-A was unable to provide one. P-A stated he continued to work on P1 while his partner P-B went into the house with RN-A to look for information on the patient. He stated his partner was in the house for approximately 10 minutes before he had to leave because P1’s oxygen level was dropping, and they needed to get him to the hospital. During an interview on 6/16/22, at 9:13 a.m. P-B stated when they arrived at the patient’s home P1 was in bed, with an oxygen saturation monitor on his foot, and it was “alarming in the mid to low 80’s.” P-B also stated we asked for P1’s demographic sheet and medication list but RN-A was unable to give us any of this information. The only thing RN-A gave us was a physician orders for life sustaining treatment (POLST). P-B stated P-A was working on the patient, I went to work with RN-A on getting information. RN-A was trying to find P1’s medical record information on the computer, but it looked like he didn’t know how to use the computer and he couldn’t give us any diagnoses. He did find the medication list and offered to write it down, but we could not wait because the patient was not doing well. During an interview on 6/15/22, at 12:46 p.m. registered nurse (RN)-A stated on 6/5/22 at approximately 5:00 a.m. he called 911 because P1 was vomiting from his mouth and tracheostomy, and he was afraid P1 was going to aspirate. RN-A stated approximately 15 minutes later, two police officers arrived and then the paramedics. The paramedics asked him how much oxygen P1 was on and asked him to print a medication list. RN-A went to print it but there was no printer. He started writing the medications down but one of the paramedics came and told him they needed to get P1 to the hospital because his oxygen saturation level was extremely low. RN-A stated he never gave the paramedics the medication list because he was “interrupted.” RN-A also stated the only information he gave the paramedics was P1’s POLST because it was in his emergency bag. During an interview on 6/15/22, at 3:45 p.m. the director of nursing (DON) stated the process for sending a patient to the hospital included, informing the team, calling the family member/responsible party, notifying the physician, and following up with the hospital. She further stated the facility has paper/back up that includes a medication administration record (MAR), treatment sheet, and POLST. Staff are to send the documents with the patient, or they have access to faxes. If they do not have the medical records, or the MAR is not current, the facility can fax it. The DON stated they have the papers they need in a folder in the emergency bag. Each resident has an emergency bag. The Emergency Procedure/911 Calls Policy dated, 11/1/21 included as part of the procedure for calling 911 “as quickly as reasonably possible during a medical emergency, staff locates and retrieves all relevant provider orders the client may have for emergency situations. Any and all such documents found are shown to the emergency responders.”

On 4/26/22, through 4/28/22, a complaint survey was conducted. This resulted in a partial extended survey at Olidia Care Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. H8154020C/62730 was unsubstantiated, however related deficiencies were issued at G682 & G687 as a result of the complaint investigation.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation interview and document review the home health agency (HHA) failed to ensure appropriate infection control prevention measures were followed for 1 of 1 patient (P1) observed being suctioned during a home visit reviewed for patient rights. P1's current plan of care (POC) for certification period 3/4/22 through 5/2/22, signed by physician on 3/10/22 indicated P1 diagnoses included tracheostomy dependent, restrictive lung disease, tracheal diversion, spastic quadriplegic cerebral palsy and neuromuscular scoliosis. The POC indicated P1 received 24 hours complex registered nurse (RN)/ licensed practical nurse (LPN) private duty nursing (PDN) 4 to 7 days a week for all medical cares (trachea cares, maintain patent airway and ventilator management, maintain skin integrity and enteral nutrition. On 4/26/22, at 11:16 a.m. a home visit was completed and P1 and P2 were observed seated on their wheelchairs right next to each other approximately 24 inches apart in the living area. P1 was observed with a tracheostomy and both patients were non-verbal. LPN-A stated both patients were non-verbal and depended on staff for all needs including being transferred and mobility using the wheelchairs. -At 11:55 a.m. LPN-A was observed approach P1 from the right side applied sterile gloves then suctioned P1 in the living area using the portable suction machine located in the back of P1’s wheelchair as P2 sat next to P1. LPN-A suctioned P1 three times then after gathered the tubing and went to the kitchen area removed the gloves came right out then went to room cleansed his hands with hand sanitizer before approaching P1. During the observation, the director of nursing (DON) and other staff nurses and PCA were in the area. -At 12:46 p.m. P1 stated coughing secretions and LPN-A at 12:47 p.m. again, was observed suction P1 from the living room as she remained seated next to P2 wh0 was less than 6 feet and P2 did not have a mask on at the time. -At 12:48 p.m. DON stated LPN-A was not supposed to suction P1 in the living area and that he was supposed to do it in a private area as this was both an infection control and privacy for P1. During interview on 4/26/22, at 1:19 p.m. LPN-A stated because P1 had the portable suction in the living room he and other nurses were able to suction her in the living area. LPN-A stated he felt because all the staff worked with P1, P1 did not need any privacy while being suctioned. LPN-A further stated he felt there was no breach in privacy when he suctioned P1 in front of P2 because P2 had cognition of a “2-year-old.” When asked about infection control practices, LPN-A then acknowledged because P2 was seated right next to P1 he should have moved P1 away to ensure a safe distance was maintained. During the exit conference on 4/28/22, at 1:12 p.m. the administrator stated he was made aware of the observations and he acknowledged infection control was an issue but also suctioning was supposed to be a private procedure and should not have been done by the clinician in the living area with another patient in the area even if P2 was non-verbal. The administrator further stated "we don’t want people being suctioned in the living area they are to bring them to a room." The agency undated policy and procedure for Suctioning of Tracheostomy tube directed staff "3. Explain procedure to patient and provide privacy..." In addition, the policy indicated suctioning was a high risk infection control procedure.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to ensure there was process for ensuring all required staff had received at a minimum, the first dose of a multi-dose COVID-19 vaccine, before staff provide any care, treatment, or other services for the HHA and/or its patients for 4 of 4 employees; failed to have a process for ensuring that the HHA continued to follow all standards of infection prevention and control practice for reducing the transmission and spread of COVID-19 in the HHA especially by those staff who are unvaccinated or who are not yet fully vaccinated for 2 of 2 employees; HHA failed to have a process for tracking and ensuring accurate information for staff COVID-19 vaccination status 5 of 5 employees; HHA failed to have a process by which staff may request a vaccine exemption from the COVID-19 vaccination requirements based on recognized clinical contraindications or applicable Federal laws, such as religious beliefs or other accommodations for 2 of 2 employees; HHA failed to ensure 100% staff vaccination rate standard (current percent 88.5) and failed to develop policies on contingency plans for staff that are not yet vaccinated for COVID-19 as recommended by the Centers for Disease Control and Prevention (CDC) and Minnesota Department of Health (MDH) recommendations. This had the potential to affect all 26 current home health patients, their families, care givers and all 78 staff. The agency COVID-19 Proof of Vaccination and Testing policy effective date: 9/8/2021, indicated: "GENERAL STANDARDS AND EXPECTATIONS I. Proof of Vaccination Status Agency staff who are assigned to work in client’s home, must submit to agency Human Resources an attestation regarding their COVID-19 vaccination status, in the form provided in the “Forms” section of this policy. Human Resources will review the attestation form and proof of COVID-19 vaccination and verify on the attestation form that they have reviewed the proof of full COVID-19 vaccination provided by the employee. Acceptable proof that an individual is fully vaccinated against COVID-19 includes: • an original CDC COVID-19 vaccination card • a paper or electronic copy of a CDC COVID-19 vaccination card • if vaccinated in another country, then an original or copy of an alternative official vaccination record, as proof of FDA- or WHO-approved COVID-19 vaccination status. Agency staff have the right to refuse to receive a COVID-19 vaccination and to refuse to provide an attestation reflecting their COVID-19 vaccination status, but the staff member will be unvaccinated for the purposes of this policy. Proof of full vaccination against COVID-19 must legibly show, at a minimum: 1. Name of the individual vaccinated 2. Date of birth of the individual vaccinated 3. The manufacturer of the vaccine 4. The date(s) on which the vaccine was administered If the proof is not legible or verifiable in the form presented, the agency may ask the staff member to present the original document. In order to be considered fully vaccinated against COVID-19, the staff member must have received a COVID-19 vaccine that has been approved by the U.S. Food and Drug Administration (“FDA”) or the World Health Organization (“WHO”). If the vaccine was administered outside of the United States, documentation must include the above information in English. The attestation forms will be treated as confidential medical records under applicable law. Information regarding whether a staff member has shown proof of full vaccination, and information on whether the staff member must submit to mandatory COVID-19 testing, will be provided to agency HR staff, agency safety administrator, members of the agency’s staff with a business need to know, and others authorized by law. Staff who provide proof to agency Human Resources that they are fully vaccinated against COVID-19 are exempt from participation in the COVID-19 Testing Procedure under this Policy. COVID-19 Testing Procedure for Agency Staff Who Do Not Submit Proof of COVID-19 Vaccination Agency staff who show proof of full vaccination against COVID-19 are not required to submit to COVID-19 testing. Until a staff member subject to this policy submits proof of full vaccination against COVID-19, they must undergo mandatory testing for COVID-19 at least weekly, as determined by the agency. The COVID-19 test, and results must be conducted and handled in compliance with all applicable rules and laws..." During review of the vaccination cards and the exemption documentation provided by the director of nursing (DON) the following were identified and verified by the DON on 4/27/22, at 11:26 a.m. to 12:07 p.m. -A review of Licensed practical nurse (LPN)-B record revealed a physician note for exemption was on file however LPN-B had not completed an exemption form. -A review of LPN-E record revealed LPN-E had written a letter to the agency to request religious exemption however the file lacked an exemption form. When asked what the process was for staff who requested for exemption from vaccination, the DON directed the surveyor to the administrator. -A review of registered nurse (RN)-A, RN-B, RN-E and LPN-C records revealed all three staff records lacked Covid-19 vaccination. In the record where they were supposed to have uploaded the vaccination card all three staff had uploaded in-accurate information. During the review the DON verified the records and stated the staff had probably uploaded the wrong document because the system would not have allowed them to clock in. The DON further stated she was going to follow up with the staff and the human resource (HR) director was responsible for making sure the staff vaccination records were accurate. -A review of RN-C record revealed the record had one date for vaccination 10/26/21. The DON stated this was a booster and then verified the record lacked the other two series vaccination records for RN-C. -A review of RN-D, LPN-D, RN-F and LPN-F records revealed all had no vaccination cards or exemption documentation in the files. During the review the DON verified the findings and stated she was going to follow up with all the staff to obtain the information. The DON then stated LPN-F was unvaccinated and had been out of the country and thought since LPN-F had returned she had not worked. The DON stated she was going to provide the last scheduled shifts all staff without vaccination records had worked in the Month of April with patients. -A review of RN-G record revealed RN-G had brought a note from a doctor in another country which indicated RN-G had been vaccinated however, the note RN-G date of birth the manufacturer of the vaccine and the date(s) on which the vaccine was administered. -At 11:43 a.m. the HR director verified both LPN-D and RN-D were active staff as the DON was not sure. During further review of the employee records, it was revealed although these staff had no vaccination records on file at the time of the survey their recent worked shift dates were: -LPN-C worked last 4/27/22 -RN-A worked last 4/24/22 -RN-D worked last 4/10/22 -LPN-D worked last 4/28/22 -RN-E worked last 4/27/22 -RN-F worked last 4/28/22 -LPN-F worked last 4/27/22 -RN-B worked last 4/20, 4/21 -RN-G worked last 4/21, 4/25 -LPN-B worked last 4/21, 4/26 -LPN-E worked last 4/18, 4/25 During interview on 4/28/22, at 11:08 a.m. LPN-B stated the process of asking for the exemption was not easy and she did not complete any forms but had submitted a note from the doctor. LPN-B stated the agency had not provided any personal protective equipment (PPE) such as N95’s but she had her own if she was required to use them. LPN-B stated she had never been required to test for Covid-19 routinely as mitigation process since she was unvaccinated. LPN-B further stated she was being tested weekly at her other job and was willing to share the documentation with the agency but had never been asked. During an interview on 4/28/22, at 1:12 p.m. with the administrator and the DON, the administrator stated the clinical team worked on the policies, but he was also personally involved. The administrator stated the compliance officer was responsible for ensuring staff was following proper screening per the regulation and the agency had put the requirement for staff to upload their vaccination, but it had been reported to him the previous day after surveyor brought to the DON attention that some staff had put information that was not accurate to get by the billing. The administrator stated the staff had uploaded the information in the system "we thought everyone had it and we will start to do audits and will put a lock on all the staff involved." The DON then stated the agency was going to color code the documents when staff uploaded them and after management had had verified the accuracy of the document, it would be changed to green when approved. The administrator acknowledged the agency compliance team had not followed the proper procedure for staff who were exempt in regard to testing, and this was going to be implemented moving forward and the staff would have testing kits in the homes to use. The administrator also stated "we will polish this information and write the policies. Things were changing so fast during COVID and we cooperated the State Law and did not extract the State guidance to make our own policies on the way forward we will develop the policies that are required. We will consider getting it done it’s a learning process." When asked about the exempt staff documentation, the administrator stated, "I have not seen the documentation of the exempt staff. We will have to review the documentation to ensure it follows the normal guidelines."

On 4/12/22 and 4/13/22, a complaint survey was conducted. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The following complaints were found unsubstantiated: H8154018C/ Intake # 62601 & H8154019C/ Intake #62638; however, related deficiencies were issued at G572 & G608 as a result of the complaint investigation

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, interview and document review, the agency failed to inform the physician of services that were not provided and failed to provide services as indicated in the plan of care (POC) for 1 of 3 patients (P1) reviewed for services and patient rights. P1’s plan of care (POC) for certification period 3/12/22 and 5/11/22, identified diagnoses of acute and chronic respiratory failure with hypoxia, tracheostomy status and intestinal malabsorption. The POC indicated P1 received 16-24 hours complex registered nurse/licensed practical nurse (RN/LPN) private duty nursing (PDN) daily 4-7 days per week for service which included gastrostomy and tube feeding management. In addition, the POC indicated P1 was to receive passive range of motion (PROM) to all extremities twice daily and as directed by physical therapy and for tube feeding the nurse was supposed to administer the tube feeding at 95 milliliters per hour (ml/hr) continuously and hold only one hour before and after administration of Doxycycline (antibiotic) During interview on 4/12/22, at 3:46 p.m. power of attorney (POA) expressed concerns P1 was not receiving range of motion for his right side which was affected by the stroke. In addition, POA stated on 4/9/22, during a call with P1 she had noticed the tube feeding was turned off which P1 was supposed to received continuously and when she had asked RN-B, the nurse stated, “I was restricting his tube feeding because he gained a lot of weight.” POA then stated she had informed RN-B P1 had been malnourished after the stroke and had lost weight and since he started the tube feeding, he finally was gaining weight and P1 was right now where he used to be prior to the stroke. The POA stated P1 was over six feet tall and comparing the height and weight he was where he was supposed to be. During a home visit on 4/13/22, at 8:30 a.m. to 9:23 a.m. licensed practical nurse (LPN)-A was observed complete morning cares for P1. During the observation P1's tube feeding was observed to be off and disconnected from the tube attached to P1's stomach. During the cares and after LPN-A was never observed completed passive range of motion for P1 as directed by the POC. During the care observation LPN-A was observed to complete G-Tube cares around the stoma and when asked about the frequency of the tube feeding being administered to P1, LPN-A and RN-A who was in the room at the time both stated was "continuously." During an interview on 4/13/22, at 9:46 a.m. LPN-A house manager reviewed P1's POC and verified P1 was supposed to get passive range of motion (PROM) then stated, "sometimes I document sometimes I don’t it’s in the plan of care I won’t lie to you.” LPN-A verified the passive range of motion was not being completed, documented and it was not in the treatment record to be completed by staff. During an interview on 4/13/22, at 1:50 p.m. via telephone phone RN-B case manager stated the PROM was supposed to be completed twice daily as per the POC and according to the review, the order had mistakenly been discontinued on 1/13/22, and thus the nurses would not be able to know they were supposed to complete it for P1. RN-B also stated the range motion had not been completed since 1/13/22. The DON acknowledged the range motion was supposed to be provided to P1 per the POC. The agency Service Plan policy revised 8/1/21, directed staff to provide all services as indicated on the plan.

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 interview and document review, the agency failed to ensure the patient's care delivery was coordinated with the power of attorney (POA) for 1 of 3 patients (P1). In addition, failed to notify the POA when 1 of 3 (P1) was transferred to the hospital for treatment reviewed for patient rights. P1’s plan of care (POC) for certification period 3/12/22 and 5/11/22, identified diagnoses of acute and chronic respiratory failure with hypoxia, tracheostomy status and intestinal malabsorption. The POC indicated P1 received 16-24 hours complex registered nurse/licensed practical nurse (RN/LPN) private duty nursing (PDN) daily 4-7 days per week for service which included gastrostomy and tube feeding management. In addition, the POC indicated for tube feeding the nurse was supposed to administer the tube feeding at 95 milliliters per hour (ml/hr) continuously and hold only one hour before and after administration of Doxycycline (antibiotic) During review of P1's progress notes dated 3/20/22 through 3/30/22, it revealed P1 had been sent to the hospital to get his gastrostomy tube (g-tube) replaced three times on 3/20/22, 3/29/22, and 3/30/22. On 3/30/22, the medical record lacked documentation the patient responsible party and power of attorney (POA) had been notified of the transfer to the hospital. During an interview on 4/12/22, at 3:46 p.m. the POA stated the last time P1 had been to the hospital when the tube fell out and the agency staff did not tell me they had sent him in. The POA stated P1 was treated and sent back to the hospital but neither the hospital nor the agency staff had notified her as this was the third time this had happened in a brief period. During a home visit on 4/13/22, at 8:30 a.m. to 9:23 a.m. licensed practical nurse (LPN)-A was observed complete morning cares for P1. During the observation P1's tube feeding was observed to be off and disconnected from the tube attached to P1's stomach. During the care observation LPN-A was observed complete g-tube cares around the stoma and when asked about the frequency of the tube feeding being administered to P1, LPN-A and RN-A who was in the room at the time both stated was "continuously." During an interview on 4/13/22, at 9:46 a.m. LPN-A house manager stated the last time the patient had been sent to the hospital was 3/30/22 to re-insert the g-tube. LPN-A stated, "I came in the morning and the overnight nurse told me she went to get his morning meds and it was pulled out and I took him in." When asked if the guardian/POA had been notified, LPN-A stated she thought she had called the POA because the hospital had asked her if staff had informed the POA and she had told the hospital staff she was going to update the POA. LPN-A then stated every time there was a change in condition the family or guardian were notified. LPN-A reviewed P1's medical record and verified the record lacked documentation of the POA being notified. During an interview on 4/13/22, at 10:06 a.m. registered nurse (RN)-A stated he had worked with P1 this last Saturday 4/9/22, and he had spoken with P1's POA because the POA had asked why the feeding was off. RN-A then stated he had told the POA P1 was supposed to get the tube feeding continuously but "we stop it two to three hours when doing cares to give his stomach a break. That day he had three loose stools, so I gave him Imodium and stopped the feeding to give him a break." RN-A also stated the POA had told him she did not want P1's tube feeding to be stopped and he had told the POA he was going to tell the case manager to talk to the dietician to re-assess the tube feeding as resident had gained weight. RN-A further stated "I have worked with [P1] for a while. I did my best to explain the part to [POA]. I used my nursing judgement for the best interest of the patient, and I was going to talk to the case manager to talk to the dietician he had gained weight and has heart problems, and this is not good for him, and he had respiratory issues." RN-A acknowledged P1's tube feeding was supposed to be continuous, and he had not informed the physician when the plan was being altered when not administering the tube feeding as directed in the POC. RN-A stated he stopped the tube feeding before and not administered it per POC. RN-A stated he was going to follow up with the case manager and the physician about the tube feeding. During an interview on 4/13/22, at 2:12 p.m. the DON stated "they are supposed to notify the case manager and the case manager will update the family/responsible party. The nurses can communicate with the family they just need to make sure they communicate." The agency policy EMERGENCY PROCEDURE/911 CALLS reviewed 11/1/2021, directed agency nurses to conduct appropriate follow-up with the client, client’s representative, physician, case manager or others as appropriate when there was a change in condition.

On 8/23/21 through 8/27/21, a complaint survey was conducted to determine compliance with the Conditions of Participation (CoP) 42CFR Part 484, requirements for Home Health Agencies. exited on 6/24/21. Olidia Care Inc. was found not to be incompliance with the requirements at 42CFR Part 484, requirements for Home Health Agencies. The following complaint was found to be substantiated: H8154015C/31867. The Condition of Participation: Patient Rights 42 CFR 484.50 at G406 was found not met. An Immediate Jeopardy (IJ) was identified at G430. Based on interview and document review, the agency failed to ensure the provision of care and treatment was available and provided for 1 of 3 patients (P5) who required complex nursing services for care of a tracheostomy (an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube to allow breathing) This resulted in an immediate jeopardy situation due to the potential for serious harm, impairment, or death when P5, who was tracheostomy dependent and required a 24-hour staffed nurse, was left without a licensed nurse for almost 45 minutes. The immediate jeopardy (IJ) which was identified on 8/25/21, at 3:10 p.m. began on 8/21/21, at 6:50 a.m. when registered nurse (RN)-B left P5 alone with a personal care assistant (PCA) who was not trained to assess for respiratory distress or to suction P5 if he should need it. The director of nursing (DON) and the program director of home health were notified of the IJ on 8/25/21, at 3:10 p.m. The IJ was removed on 8/27/21, at 4:20 p.m. when it was verified an acceptable removal plan had been implemented. As a result of the IJ, a partial extended survey was conducted. Federal Law as specified in 42 CFR 484.80 (f)(3), prohibits any home health agency to offer and/or conduct home health aide training and/or competency testing which, within the previous two years has been subjected to an extended or partially extended survey as a result of having been found to have furnished substandard care. Hours of Operation: Monday through Friday 8:00 a.m. to 4:30 p.m.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to meet the Conditions of Participation at 484.50 Patient Rights. The agency failed to ensure 1 of 3 patients (P5) was not left alone when he required 24 hour care. Refer to G430: Based on interview and document review, the agency failed to ensure the provision of care and treatment was available and provided for 1 of 3 patients (P5) who required complex nursing services for care of a tracheostomy (an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube to allow breathing) This resulted in an immediate jeopardy situation due to the potential for serious harm, impairment, or death when P5, who was tracheostomy dependent and required a 24-hour staffed nurse, was left without a licensed nurse for almost 45 minutes. The immediate jeopardy (IJ) which was identified on 8/25/21, at 3:10 p.m. began on 8/21/21, at 6:50 a.m. when registered nurse (RN)-B left P5 alone with a personal care assistant (PCA) who was not trained to assess for respiratory distress or to suction P5 if he should need it. The director of nursing (DON) and the program director of home health were notified of the IJ on 8/25/21, at 3:10 p.m. The IJ was removed on 8/27/21, at 4:20 p.m. when it was verified an acceptable removal plan had been implemented.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure the provision of care and treatment was available and provided for 1 of 3 patients (P5) who required complex nursing services for care of a tracheostomy (an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube to allow breathing) This resulted in an immediate jeopardy situation due to the potential for serious harm, impairment, or death when P5, who was tracheostomy dependent and required a 24-hour staffed nurse, was left without a licensed nurse for almost 45 minutes. The immediate jeopardy (IJ) which was identified on 8/25/21, at 3:10 p.m. began on 8/21/21, at 6:50 a.m. when registered nurse (RN)-B left P5 alone with a personal care assistant (PCA) who was not trained to assess for respiratory distress or to suction P5 if he should need it. The director of nursing (DON) and the program director of home health were notified of the IJ on 8/25/21, at 3:10 p.m. The IJ was removed on 8/27/21, at 4:20 p.m. when it was verified an acceptable removal plan had been implemented. P5’s plan of care (POC) for certification period 8/4/21 to 10/2/21, identified diagnoses including, acute and chronic respiratory failure, history of recurrent aspiration pneumonia, dementia, cerebral palsy and cognitive delay. The POC indicated P5 was to receive services of 16 to 24 hours complex registered nurse/licensed practical nurse (RN/LPN) private duty nursing (PDN) 7 days a week for 60 days. The POC indicated P5 had a tracheostomy. In addition, the POC indicated the private duty nurse was to suction P5 every three to four hours; was to assess/observe for shortness of breath, difficulty breathing and/or hypoxia (low blood oxygen); the nurse was to assess/observe for oxygen home safety precautions and administer oxygen via trach and increase oxygen flow rate if necessary. When interviewed on 8/24/21, at 3:38 p.m. RN-A case manager stated she was notified on the morning of 8/21/21, by PCA-A, that RN-B had left early at 6:30 a.m. and there was no licensed nurse in the home. RN-A stated PCA-A was not trained to complete suctioning for P5 or to assist with respiratory distress if there had been any concern with this. RN-A also stated, P5’s had no staff in the home at all, when PCA-A left the home at 7:00 a.m. and when PCA-A called RN-A, to let her know she had left the home with no staff as her transportation had arrived, she had directed her back to the home immediately, which had resulted in no staff being in the home for approximately 5 minutes. RN-A further stated, RN-C who was to work in the same home but with a different patient, had also informed her she was going to be 11 minutes late that morning as she was supposed to arrive at 7:00 a.m. When interviewed on 8/24/21, at 5:17 p.m. RN-C stated she had arrived at the home at 7:15 a.m. on 8/21/21, and was informed by PCA-A, that RN-B the overnight nurse assigned to P5 had left early. RN-C stated on arrival she immediately went to check on P5 and found P5 needed to be suctioned (suctions out mucous and secretions to clear airway for breathing) because he had, “gurgling lung sounds, and you could tell he needed to be suctioned. RN-C further stated P5 is non-verbal and would not be able to tell you if he needed anything.” RN-C also stated training had been provided recently on staff making sure they gave report to the next staff and had to make sure the person was certified and competent to care for the needs of the patient, all staff at were not supposed to leave any patient alone and they were supposed to complete the shift reporting. RN-C further stated P5, “required 24/7-hour nursing care.” When interviewed on 8/24/21, at 6:12 p.m. PCA-A stated on 8/21/21, at around 6:30 a.m. RN-B who was assigned to P5 on the night shift of 8/20/21 through 8/21/21, had left the home without another trained caregiver or staff. PCA-A stated her ride came at 7:00 a.m. and she had also left the home and then once on her transportation, had called RN-A to let her know she had left, and RN-A had directed her to immediately return to the home. PCA-A stated she returned; however, the home was completely without staff for approximately 5 minutes. When interviewed on 8/24/21, at 5:36 p.m. RN-B stated prior to agreeing to pick up the shift when the staffing coordinator (SC) had called to ask, he had communicated with the SC he would be leaving at 6:30 a.m. on 8/21/21, because he was supposed to work at his other job at 7:00 a.m. and he could not be late. RN-B stated the staffing coordinator had told him to leave P5 because the other staff, PCA-A was in the home. RN-B stated he was not aware PCA-A was not qualified to be left with P5. RN-B stated although, he was scheduled until 6:30 a.m. he stayed on until 6:50 a.m. and then left P5 after he reported to PCA-A and had also written down report for the next licensed nurse. RN-B stated since he came back from vacation this was his second shift however, he had not been provided any training regarding not leaving patients alone without a competent caregiver, reporting and completing the communication book. RN-B further stated “I did not know they was a change in policy.” When interviewed on 8/25/21, at 9:54 a.m. the agency administrator stated the agency had terminated RN-B the previous day following the incident. The administrator stated training on staff not leaving patients alone, completing shift reporting, which included certifying a staff or caregiver was competent to care for the patient and completing the communication book documentation had been implemented following the previous survey and the staff who had not been around at the time had 14 days to complete it before being deactivated from the system. The administrator stated according to the video clip, RN-B had documented dates with times that he may have clicked on the video however, the administrator acknowledged there was no way they were able to see if the staff had watched the entire video to ensure they had received the content. The administrator stated RN-B did not follow the agency procedure, and he had told them he did not know PCA-A was not competent. The administrator stated following the incident, management had decided to report to the State Agency (SA), then started to investigate and informed the rest of the staff about the incident, but no re-education had been implemented to make sure all the staff had received the training because this was, “an isolated incident.” The administrator acknowledged RN-B should have stayed until the following shift when the next staff arrived, and he should have called the agency number to let them know that his replacement had not arrived so other arrangements could be made. When interviewed on 8/25/21, at 8:52 a.m. the DON stated RN-B was not supposed to leave P5 without licensed nurse coverage. The DON stated although PCA’s were assigned to other patients with tracheostomy, they were not trained to perform respiratory assessments or suctioning such as P5 required. The DON stated the staffing coordinator was not supposed to tell staff to leave patients unattended. The DON stated she would expect the staff to give report to a trained and/or licensed nurse before leaving and the staff was supposed to complete the communication book to indicate a trained, certified, and competent caregiver was taking over the patients care. The DON stated although RN-B had not received the training when it had been provided following the prior survey, he had 14 days to complete it upon return from his vacation. The DON stated following the incident involving P5 being left alone, the management team did not feel all staff needed to be retrained because this was an isolated incident involving one nurse and the other staff had already been informed about it. The DON stated RN-B had been terminated. When interviewed on 8/25/21, at 9:22 a.m. the staffing coordinator (SC) stated he had scheduled RN-B on 8/20/21 through 8/21/21, from 7:00 p.m. to 6:30 a.m. The SC stated he had called RN-D who worked that morning and had asked him to come early for RN-B and RN-D had expressed he had ride issues but was going to try to be there. The SC stated he felt the communication had been established with the coverage. The SC stated he did not have the authority to tell the nurses to leave the patients and he expected RN-B to have given him a call that morning at 6:30 a.m. so he could have made other arrangements or called RN-D to see where and when he would arrive. The undated, facility Abuse and Neglect Training, indicated under Abandonment, "The law describes abandonment Action or inaction by another person or entity with the duty of care for a vulnerable adult that leaves the vulnerable person without the means or ability to obtain necessary food, clothing, shelter, or health care." In addition, the training indicated under Neglect included, is an act or omission by a person or entity with a duty of care that demonstrates a serious disregard of consequences of such a magnitude as to constitute a clear and present danger to the vulnerable adult's health, welfare, or safety, including but not limited to conduct prohibited. The agency undated Shift Reporting policy directed the staff the following: “1. Before leaving the bedside care, you verified that the upcoming Caregiver has been well trained in all aspects of the care of your patient. 2. Before leaving the bedside care you must certify that the upcoming caregiver is physically present in the patient care area during the reporting and fit to provide care. 3. Before leaving the bedside care you must certify that the upcoming caregiver is skilled and fully capable of providing the same level of care to your patient. 4. Before leaving the bedside care you must complete the reporting section of the patient Communication Book. The IJ was removed on 8/27/21, at 4:20 p.m. when the agency took the following actions which were verified on 8/27/21, by interview and document review: All the staff were notified electronically of the need to complete all the training by 11:59 p.m. on 8/27/21 and taking a quiz following the training otherwise if they had not completed the training by that time they were going to be deactivated from the agency system (unable to work) and would only be re-activated by the DON after completing the training before working their next shift. The shift Reporting training directed licensed staff before leaving the bedside care the caregiver was to verify that the upcoming caregiver had been well trained and fully orientated in all aspects of the care of your patient; the caregiver was to certify that the upcoming caregiver was physically present in the patient care area during the reporting time and fit to provide care; the caregiver was to certify that the upcoming caregiver was skilled, competent, and capable of providing the same level of care to the patient and the caregiver was to complete the Upcoming Caregiver Certification section of the patient Communication Book. In addition, the agency provided and posted phone numbers of all managers and patient caregivers in all patient care areas and all the office managers including the staffing manager/coordinator also completed the shift reporting training and were informed of the agency policies and procedures which would assist them to make the right requests pertaining to shift coverage.

On June 15, 2021 through June 24, 2021, an abbreviated survey was conducted at your agency to conduct a complaint investigation. Olidia Care Inc was found NOT to be in compliance with requirements at 42 CFR Part 484, requirements for Home Health Agencies. During the survey, the following complaints were investigated and substantiated H8154009C/MN73519/73533) H8154010C /MN73905 H8154013C/ MN73998 H8154011C/MN70147 H8154012C/MN69724 The Condition of Participation: Patient Rights 42 CFR 484.50 at G406 was found not met. An Immediate Jeopardy (IJ) was identified at G430 The Immediate Jeopardy began on 6/02/21, at 7:00 p.m. when licensed practical nurse (LPN)-A was instructed to leave P1 and reregistered nurse (RN)-B was on her way by the staffing coordinator (SC)-A to take over cares for P1. LPN-A was instructed by the SC-A there was another patient that needed more emergent care and had not nursing staff so LPN-A was instructed he must go there immediately. The administrator was notified of the IJ on 6/15/21, at 12:15 p.m. The IJ was removed on 6/24/21, when it was verified an acceptable removal plan had been implemented. The Condition of Participation: 484.60 at G570 Care planning, coordination, quality of care was not met. As a result, an extended survey was conducted. Federal Law as specified in 42 CFR 484.80 (f)(3), prohibits any home health agency to offer and/or conduct home health aide training and/or competency testing which, within the previous two years has been subjected to an extended or partially extended survey as a result of having been found to have furnished substandard care. Hours of Operation: Monday through Friday 8:00 a.m. to 4:30 p.m.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to meet the Condition of Participation at 484.50, Patient Rights. The agency failed to ensure 1 of 1 patients (P1) was not left alone when he required 24 hour care. In addition, the agency failed to provide the ordered treatments for 1 of 1 patient (P2) who required an antibiotic instilled into the bladder daily. Findings include: Refer to G430: The agency failed to ensure neglect did not occur for 1 of 3 patients (P1), reviewed for neglect. This resulted in an immediate jeopardy situation due to the potential for serious harm, impairment or death to P1, when P1, who was ventilator dependent and required a 24 hour staffed nurse, was left alone for almost 3 hours, and his service agreement instructed to call 911 if no nurse present and was not initiated. In addition to the resident in immediate jeopardy, the facility failed to provide daily skilled nursing and medication administration for 1 of 1 patients (P2) who required antibiotic solution instilled into the bladder daily to decrease and/or prevent urinary tract infections (UTI). The immediate jeopardy (IJ) which was identified on 6/15/21, at 12:15 p.m. began on 6/2/21, at 7:00 p.m. when licensed practical nurse (LPN)-A left P1 alone with his untrained wife for almost 3 hours, after being instructed to tend to another patient. The administrator was notified of the IJ on 6/15/21, at 12:15 p.m. The IJ was removed on 6/24/21, when it was verified an acceptable removal plan had been implemented. Refer to G488: The agency failed to immediately report to the State Agency (SA), an allegation of neglect and abuse for 1 of 1 patient (P1), who was nursing dependant and ventilator dependent and required 24-hour nursing care who was left unattended for 3 hours without a staffed nurse present on 6/2/21. P1's service agreement indicated if there was no nurse present, 911 should be contacted and he should be hospitalized. This did not occur.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure neglect did not occur for 1 of 1 patients (P1), reviewed for neglect. This resulted in an immediate jeopardy situation due to the potential for serious harm, impairment or death to P1, when P1, who was ventilator dependent and required a 24 hour staffed nurse, was left alone for almost 3 hours, and his service agreement, which gave instructions to call 911 if no nurse present, was not initiated. In addition to the resident being in immediate jeopardy, the facility failed to provide daily skilled nursing and medication administration for 1 of 1 patients (P2) who required antibiotic solution instilled into the bladder daily to decrease and/or prevent urinary tract infections (UTI). The immediate jeopardy (IJ) which was identified on 6/15/21, at 12:15 p.m. began on 6/2/21, at 7:00 p.m. when licensed practical nurse (LPN)-A left P1 alone with his untrained wife for almost 3 hours, after being instructed to tend to another patient. The administrator was notified of the IJ on 6/15/21, at 12:15 p.m. The IJ was removed on 6/24/21, when it was verified an acceptable removal plan had been implemented. P2 was admitted to the HHA on 10/21/19, with the most recent plan of care (POC) certification period of 5/29/21 to 7/28/21. The POC included the following diagnoses: urinary retention and quadriplegia (paralyzed in all four limbs). The POC included, skilled nursing up to 6 hours/day for 60 days due to increased urinary retention and straight catheterization (a catheter inserted into the bladder to drain urine)needs. P2 was a 34 year old man and used an electric wheelchair for mobility. The POC identified P2 required an antibiotic, Gentamicin solution 480 milligrams (mg)/liter of 0.9% normal saline (NS) compound. Instill 60 milliliters (ml) into the bladder every night at bedtime. This solution was used to treat or prevent difficult urinary tract infections (UTI's). Certification periods 3/29/21 to 5/29/21, 1/29/21 to 3/29/21, 11/30/20 to 1/29/21 and 10/1/20 to 11/30/20 included the order for the Gentamicin to be instilled in the bladder daily. During a phone interview on 6/22/21, at 8:30 a.m. registered nurse care coordinator at the University of Minnesota Fairview Hospital (RN)-F stated, P2 had been admitted to the hospital on 6/13/21, with a UTI. P2 was approved for 6 hours of RN home services daily and required daily Gentamicin irrigations of the bladder to prevent UTI's. P2 had told RN-F he had only 5 RN visits for the bladder irrigation in the past two weeks prior to this hospitalization for a UTI. RN-F reached RN-A at Olidia Care, however, RN-A was not able to reassure her the agency would have the availability for an RN to visit P2 daily as ordered for the Gentamicin bladder irrigations. P2 had declined being admitted to a transitional care unit or a skilled nursing facility until the agency could meet his needs. P2 did not want his wife to have to learn and complete the bladder irrigations due to having several small children at home. However, P2 had agreed to have his wife learn this until the agency could provide his needs as ordered. P2 would like to have the care Olidia HHA had agreed to provide. RN-A was able to reassure RN-F a nurse would come to P2's home and teach his wife how to complete the bladder irrigations on 6/14/21, when he was discharged from the hospital, in case the agency was unable to provide the service daily. During an interview on 6/22/21, at 10:00 a.m. RN-A stated she had spoken to RN-F on 6/14/21, and assured her there would be a nurse to complete the 6/14/21, visit and teach P2's wife how to instill the Gentamicin as ordered. However, RN-F discovered there was no nurse available to complete the 6/14/21 visit. RN-F stated no one had completed the visit and arrangements had not been made to teach P2's wife. During an interview on 6/22/21, at 9:30 a.m. licensed practical nurse (LPN)-D stated she had worked with P2 on 6/15/21 and 6/16/21 and the agency had not directed her to teach P2's wife how to instill the Gentamicin into P2's bladder, nor had P2 asked her to. During a phone interview on 6/17/21, at 11:00 a.m. P2 stated he required a straight catheterization every 4 hours to empty his bladder and at night he is to have an antibiotic (Gentamicin) instilled into the bladder to prevent infections. This had helped prevent UTI's with him having a UTI about every 6 months while on the Gentamicin, versus about every 2 months prior. However, in the past 6 months he has had 3 UTI's and needed to be hospitalized for each. P2 stated he feels this is related to not getting the antibiotic instilled into his bladder routinely as ordered. The agency had been unable to send a nurse daily as ordered. P2 stated, "Every month it has been getting worse. Right now it is worse. Right now I am supposed to have medication in the bladder every night and when they don't come then I don't get the medicine. I have had more infections when I don't get the medicine." During a phone interview on 6/21/21, at 10:34 a.m. P2 clarified he has a patient care aide (PCA) from another agency who stays with him from 12:00 a.m. until 9:00 a.m. The PCA's had not been trained to do the Gentamicin irrigations and were not qualified to do so. P2 reported his wife was not able to perform the bladder irrigations as she must provide care to their 4 young children in addition to providing his care when no nurse or PCA is present. P2's nurse visit records identified the following missed visits and missed Gentamicin bladder treatments. June 2021-12 visits missed (1,4,5,6,7,8,10,11,14,18,19,20 ). Hospital 6/13/21 to 6/14/21). Reviewed through 6/20/21. May 2021-21 missed visits (2,3,4,7,8,9,11,13,14,16,17,18,20,21,22,23,25,26,28,30,31). April 2021-19 missed visits (2,3,4,5,6,9,10,11,12,13,17,18,19,20,23,24,25,27,30). March 2021-12 missed visits (1,2,3,4,5,6,23,25,27,28,29,30) (hospitalized from 3/7 through 3/17). February 2021-12 missed visits (1,2,5,6,7,11,12,15,16,22,25,26). January 2021-11 missed visits (1,8,9,10,14,15,17,22,24,28,29). December 2020-7 missed visits (3,4,13,15,25,30,31). November 2020-8 missed visits (1,4,10,12,14,15,27,29) (Hospital 11/16 to 11/26) October 2020-10 missed visits (6,7,8,11,12,14,18,22,26,31). During a phone interview on 6/17/21, at 9:17 a.m. RN-A stated the agency had difficulty providing a nurse for P2 as he required a 6 hour shift, from 6:00 p.m. until 12:00 a.m. Staff worked in other homes and could not be available at those specific hours. RN-A stated P2 often did not have the Gentamicin instilled in his bladder as ordered because they simply could not provide the staff. The agency did not have any kind of back up plan for P2 to receive the ordered treatment. RN-A had not reported the missed doses of Gentamicin the P2's primary physician or urologist, nor had she reported the missed visits. During a phone interview on 6/21/21, at 10:00 a.m. RN-A stated she thought maybe the PCA agency staff could do the Gentamicin bladder irrigations since P2 received PCA services daily from another agency. During a phone interview on 6/21/21, at 11:20 a.m. P2's PCA agency Loyalty Community Health's assistant administrator stated, their PCA's are unable to perform medical interventions such as the Gentamicin being instilled into P2's bladder. The agency did not have any orders to do this and have never done so. The do assist P2 with the straight catheterization every four hours. During a phone interview on 6/22/21, at 3:23 p.m. the administrator stated he had visited P2, "The root of the problem is staffing. [P2] is very specific on the hours he wants staffed by the nurses and adamant that he does not want his spouse to do the antibiotic bladder irrigations." The administrator stated, P2's primary care provider should have been notified of the missed visits and missed Gentamicin bladder treatments, but had not been. During a phone interview on 6/24/21, P2's nurse practitioner (NP)-C, stated she had not been informed P2 had so many missed visits and had not been receiving the Gentamicin as ordered. P2 had complex bladder issues and the missed Gentamicin may or may not have caused the UTI's in the past 6 months. Medication Management Program, undated, page 14, Medication Errors (includes medication dose omitted) directs: When an actual or potential medication error occurs, the prescribing physician/licensed independent practitioner and Olidia Care are to be notified immediately by the clinical staff member who identifies the error. An Incident Report is to be completed and forwarded to Administration. Documentation will include the name and dose of the drug, patient's response, time of physician notification and any orders received. Actual or potential medication errors will be tracked and trended as part of the performance improvement activities of the Olidia Care. Summary reports of findings, conclusions, actions taken and recommendations for improvement will be generated by the Performance Improvement department/Committee. Summary reports are submitted to the Professional Advisory committee and/or Board of Directors. P2's service agreement dated 9/15/19, included the agency would follow the physician orders for medication. The contingency plan indicated, "24 hours a day the agency can be reached in emergency. Essential Services: If services are needed for medical or safety reasons and Olidia Care Inc is unable to keep the appointment, Olidia care shall make arrangements acceptable to the client and/or responsible person to complete services. In case of emergency or significant change in the client condition, you can immediately reach Olidia Care by phone 24 hours a day." Based on interview and document review, the agency failed to ensure neglect did not occur for 1 of 1 patients (P1), reviewed for neglect. This resulted in an immediate jeopardy situation due to the potential for serious harm, impairment or death to P1, when P1, who was ventilator dependent and required a 24 hour staffed nurse, was left alone for almost 3 hours, and his service agreement instructed to call 911 if no nurse present and was not initiated. In addition to the resident in immediate jeopardy, the facility failed to provide daily skilled nursing and medication administration for 1 of 1 patients (P2) who required antibiotic solution instilled into the bladder daily to decrease and/or prevent urinary tract infections (UTI). The immediate jeopardy (IJ) which was identified on 6/15/21, at 12:15 p.m. began on 6/2/21, at 7:00 p.m. when licensed practical nurse (LPN)-A left P1 alone with his untrained wife for almost 3 hours, after being instructed to tend to another patient. The administrator was notified of the IJ on 6/15/21, at 12:15 p.m. The IJ was removed on 6/24/21, when it was verified an acceptable removal plan had been implemented. Findings include: P1's plan of care (POC) with the certification period 4/26/21 to 6/21/21, indicated he was to receive services 24 hours day, 365 days a year for complex monitoring and supervising and accessibility to skilled nursing services by provided duty nursing personnel. In addition, the POC indicated P1 was a paraplegic (paralysis of lower part of body), had a tracheostomy (an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube to allow breathing) and was ventilator (machine allows to breath) dependant. During interview 6/15/21, at 11:25 a.m. home care agency registered nurse (RN)-A stated P1 was paraplegic and required 24-hour nursing care and was not to be left alone and required 24 hour 7 days a week of nursing care services. RN-A stated she was notified on the morning of 6/3/21, by RN-L, on the evening of 6/2/21, licensed practical nurse (LPN)-A left his shift early at 7:00 p.m. and P1 was left alone until the next nurse arrived around 9:55 p.m. LPN-A was told by the staffing coordinator (SC) he had to leave to care for another emergent client. An investigation into the incident was not completed per RN-A because she did not have the authority to do so. During interview 6/15/21, at 1:10 p.m. agency administrator stated he was made aware of the incident on 6/3/21, by P1's insurance company Medica and immediately informed RN-A to file a report around 11 a.m. The administrator stated he thought RN-A completed the investigation and he provided LPN-A a written write up on 6/14/21, (12 days after the incident) informing LPN-A he should not have left P1 alone since P1 required 24 hour nursing services. The agency administrator stated he felt there was no reason to re-educate the rest of the staff since he felt this was an isolated incident and nursing should just use their common sense on a situation like this. In addition, the administrator stated he did not complete an investigation since he thought RN-A did. During interview 6/15/21, at 2:08 p.m. LPN-A stated he was instructed by the staffing coordinator (SC) to leave P1 at 7:00 p.m. to be with another patient who was vent dependent who was alone and required 24 hour nursing care. LPN-A further stated he thought he was doing the correct thing because the (SC) told him a replacement was on the way to take care of P1. During interview 6/15/21, at 6:08 p.m. (SC) stated he was aware P1 was not to be left alone since he was vent dependant and needed 24 hour 7 day a week care, but he also had an additional patient who was without a nurse, so he instructed LPN-A to leave P1 to help the other patient and P1's spouse was home so he thought it was ok. The SC stated he thought P1's spouse would be able to provide cares in the absence of a nurse but was unsure if there was any contract or training of P1's spouse to provide vent treatment. SC was unaware P1's service agreement identified if he was to be without a nurse present, 911 needed to be contacted so P1 could be transported to the hospital. During interview 6/15/21, at 6:39 p.m. and P1 stated the (SC) called his wife on 6/2/21, in the evening around 6:50 p.m. and stated LPN-A had to leave at 7:00 p.m. to take care of an emergency. P1 stated his wife was not ok with this and he would never have agreed with that. "I am on a ventilator and they sometimes use Ambu bag [bag to breath for patient, conducted by a nurse, if off mechanical ventilator] on me, and my wife could not do that and she is not trained on cares for my vent. I could die if left alone without a nurse." In addition, P1 stated he and his wife never agreed his wife would be a backup for the agency if they did not have nurses available to provide cares for his vent. Furthermore, "The [SC] told me the nurse would be here shortly not several hours later. My wife and I were very scared! During interview 6/15/21, at 7:40 p.m. RN-B stated she was scheduled 11:00 p.m. to 7 :00 a.m. and was asked to start earlier on 6/2/21, and never agreed to the earlier start of shift. RN-B stated she received a call from P1 that there was no nurse around 8 p.m. and she told him she would arrive as soon as she could which was around 10:00 p.m. RN-B stated, she never agreed to arriving early and told the SC she had plans and the SC was aware of this. RN-B stated, she arrived as soon as she could once she was made aware and arrived one hour earlier art 10:00 p.m. The facility Abuse and Neglect Training undated indicated under Abandonment, "The law describes abandonment Action or inaction by another person or entity with the duty of care for a vulnerable adult that leaves the vulnerable person without the means or ability to obtain necessary food, clothing, shelter, or health care." In addition, the training indicated under Neglect included, is an act or omission by a person or entity with a duty of care that demonstrates a serious disregard of consequences of such a magnitude as to constitute a clear and present danger to the vulnerable adult's health, welfare, or safety, including but not limited to conduct prohibited. The IJ was removed on 6/24/21, when the agency took the following actions which were verified on 6/24/21, by interview and document review: The agency reviewed each patient to ensure nursing coverage as ordered, ensured each patient had a back up plan in case of staffing shortage, which was documented in the clinical record and POC, all staff were notified electronically of the need to have training prior to the start of their next shift. All staff who were currently working had been trained as verified by interview on 6/24/21, between 9:00 a.m. and 12:00 p.m.

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to immediately report to the State Agency (SA), an allegation of neglect for 1 of 1 patient (P1), who was nursing dependant and ventilator dependent and required 24-hour nursing care who was left unattended for 3 hours without a staffed nurse present on 6/2/21. P1's service agreement indicated if there was no nurse present, 911 should be contacted and he should be hospitalized. This did not occur. Findings include: P1's plan of care (POC) with the certification period 4/26/21 to 6/21/21, indicated he was to receive services 24 hours day, 365 days a year for complex monitoring and supervising and accessibility to skilled nursing services by provided duty nursing personnel. In addition, the POC indicated P1 was a paraplegic (paralysis of lower part of body), had a tracheostomy (an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube to allow breathing) and was ventilator (machine allows to breath) dependant. When interviewed on 6/15/21, at 11:25 a.m. registered nurse (RN)-A stated P1 was quadriplegic (paralysis of all four limbs) and relied on a ventillator for breathing. P1 was to have 24 hour nurse coverage and was not to be left alone without a trained care giver. If there was no nurse to be with P1, they were directed to call 911 and have him sent to the hospital. RN-A had been notified on the morning of 6/2/21, P1 had been left alone for almost 3 hours on 6/2/21 from 7:00 p.m. until 10:55 p.m. RN-A had reported the incident to the state agency on 6/3/21, at 1:00 p.m. and stated she was unaware the incident should have been reported immediately. During interview 6/15/21, at 2:08 p.m. LPN-A stated he was instructed by the staffing coordinator (SC) to leave P1 at 7:00 p.m. to be with another patient that was vent dependent that was alone that required 24 hour nursing care. LPN-A further stated he thought he was doing the correct thing because the (SC) told him a replacement was on there way to take care of P1, and never thought he was doing anything wrong. During interview 6/15/21, at 7:40 p.m. RN-H stated the SC called her on 6/1/21, and asked me if I was able to come in at 7:00 p.m. on 6/2/21, and on 6/2/21, at 4:00 p.m. I sent him a text message telling him I would not be able to come in early and would arrive at my normal scheduled shift with P1 at 11:00 p.m. RN-H stated the SC never responded. RN-H stated P1 called her around 8:30 p.m. and informed her there was no staff at his home so she rushed over to his home and arrived around 10:00 p.m. RN-H stated she was not aware she was supposed to immediately report the incident and she reported the incident the following morning 6/3/21, to the next on coming nurse RN-L. The agency's Abuse And Neglect Training undated indicated under Reporting "Any person can report abuse even i you are not a mandatory reporter. Mandatory reporters are professionals identified by law who must make a report if they have reason to believe the abuse, abandonment, neglect, or financial exploitation of a vulnerable adult has occurred. The training further indicated the report must be done immediately and the Minnesota Adult Abuse Reporting Center (MAARC) is open 24 hours a day, seven days a week.

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 interview and document review, the agency was found not to be in compliance with the Condition of Participation at 484.60, Care Planning, Coordination, Quality of Care. The agency failed to provide services according to the plan of care approved by the medical provider 3 of 3 patients (P2, P3 and P4) who had missed services. Findings include: Refer to G572: The home health agency (HHA) failed to provide services as indicated in the plan of care (POC) for 3 of 4 patients (P2,P3 and P4) reviewed for following POC. Refer to G578: The home health agency failed to provide a physician ordered treatment for 1 of 4 patients (P2) reviewed for conformance with physician orders.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to provide services as indicated in the plan of care (POC) for 3 of 4 patients (P2, P3 and P4) reviewed for following POC. P3's most recent POC certification period of 5/11/21 to 7/10/21, included the following diagnoses of non-traumatic intracerebral (brain) hemorrhage and epilepsy. P3 required a feeding tube and skilled nursing services 24 hours/day for 60 days due to the complex needs of the client and dependence for all cares, feeding, medication administration and treatments of RN/LPN (licensed practical nurse). The POC indicated P3 was admitted on 5/12/21. Review of the nurse visit records indicated the following missed visits from 5/13/21 to 6/16/21: -5/24/21- missed 24 hours of care -6/4/21- missed 24 hours of care -6/11/21- missed 24 hours of care -6/12/21- missed 24 hours of care -6/13/21- missed 24 hours of care In addition, when reviewing the nursing time cards for P3 there was not one day during the time frame from 5/13/21 to 6/16/21 where the patient received 24 hours of care. The record lacked documentation that P3's physician was notified of the missed visits. During interview 6/17/21, at 5:00 p.m. agency administrator stated the agency's POC's should state up to 24 hours of care a day, "so we should be covered and there is no reason for missed visits so the physician would not need to be notified." During interview 6/18/21, at 8:06 p.m. RN-G stated she had worked with P3, was aware there were missed visits and sometimes the family has had to help take care of P3. RN-G stated she was not aware the physician needed to be notified of the missed visits and had not done so. P4's most recent POC certification period of 4/28/21 to 6/27/21, included the following diagnoses of tracheostomy (an opening in the neck so a tube can be inserted into the windpipe to help with breathing)and seizures. The POC further indicated P4 was to receive 12 hours of complex RN/LPN private duty nursing 7 days a week due to anoxic brain injury, acute respiratory failure and high risk of aspiration. Review of the nurse visit records indicated the following missed visits from 5/17/21 to 6/15/21: -5/21/21 -5/22/21 -5/23/21 -5/28/21 -6/3/21 -6/5/21 -6/6/21 -6/8/21 -6/9/21 -6/10/21 -6/11/21 -6/12/21 The record lacked documentation that P4's physician was notified of the missed visits. During interview 6/17/21, at 10:47 a.m. RN-K stated the agency does not have enough nurses and they have not had a director of nursing (DON) in over a year. RN-K stated staffing is very short with her patients and they are, "struggling to provide the care that is needed for them." In addition, RN-K stated P4 needs 12 hours of nursing services and if they do not have enough staff the family has to take over. RN-K stated she has been with the agency for along time and was not aware they needed to contact the physician of missed visits. During interview 6/17/21, at 11:30 a.m. RN-A stated she was aware several of the clients in the agency were missing visits and had never informed the physician. RN-A further stated she was unaware of any policy of missed visits. Oildia Missed Visits Policy, undated, included, A missed visit is an altercation in the plan of care; therefore, the physician must be notified. Visits should only be missed for adequate reasons and not for staff convince. The patient and representative must all be notified of the missed visit and documented on the clinical note or communication note along with the rational for missing the visit. Based on interview and document review, the home health agency (HHA) failed to provide services as indicated in the plan of care (POC) for 3 of 4 patients (P2, P3 and P4) reviewed for following POC. Findings include: P2 had a start of care (SOC) date of 10/21/19, with the most recent plan of care (POC) certification period of 5/29/21 to 7/28/21. P2's diagnoses included urinary retention and quadriplegia (paralysis all four limbs). P2 was to have skilled nursing up to 6 hours per day for straight catheterization (catheter inserted into bladder to drain urine and removed). P2 was also to receive Gentamicin solution (antibiotic) instilled into the bladder at bedtime. Certification periods 3/29/21 to 5/29/21, 1/29/21 to 3/29/21, 11/30/20 to 1/29/21 and 10/1/20 to 11/30/20 included the order for the Gentamicin to be instilled in the bladder daily. P2's nurse visit records identified the following missed visits and missed Gentamicin bladder treatments. June 2021-12 visits missed (1,4,5,6,7,8,10,11,14,18,19,20 ). Hospital 6/13/21 to 6/14/21). Reviewed through 6/20/21. May 2021-21 missed visits (2,3,4,7,8,9,11,13,14,16,17,18,20,21,22,23,25,26,28,30,31). April 2021-19 missed visits (2,3,4,5,6,9,10,11,12,13,17,18,19,20,23,24,25,27,30). March 2021-12 missed visits (1,2,3,4,5,6,23,25,27,28,29,30) (hospitalized from 3/7 through 3/17). February 2021-12 missed visits (1,2,5,6,7,11,12,15,16,22,25,26). January 2021-11 missed visits (1,8,9,10,14,15,17,22,24,28,29). December 2020-7 missed visits (3,4,13,15,25,30,31). November 2020-8 missed visits (1,4,10,12,14,15,27,29) (Hospital 11/16 to 11/26) October 2020-10 missed visits (6,7,8,11,12,14,18,22,26,31). P2's medical record lacked any evidence the physician had been notified of the missed visits, or of the medication error by omission on the Gentamicin. During a phone interview on 6/17/21, at 9:17 a.m. RN-A stated the agency had difficulty providing a nurse for P2 as he required a 6 hour shift, from 6:00 p.m. until 12:00 a.m. Staff worked in other homes and could not be available at those specific hours. RN-A stated P2 often did not have the Gentamicin instilled in his bladder as ordered because they simply could not provide the staff. RN-A verified the missed bladder treatment on the days listed above. The agency did not have any kind of back up plan for P2 to receive the ordered treatment. RN-A had not reported the missed doses of Gentamicin the P2's primary physician or urologist, nor had she reported the missed visits. During a phone interview on 6/17/21, at 11:00 a.m. P2 stated he required a straight catheter every 4 hours to empty his bladder and at night he is to have an antibiotic (Gentamicin) instilled into the bladder to prevent infections. The agency had been unable to send a nurse daily as ordered. P2 stated, "Every month it has been getting worse. Right now it is worse. Right now I am supposed to have medication in the bladder every night and when they don't come then I don't get the medicine. I have had more infections when I don't get the medicine." During a phone interview on 6/22/21, at 3:23 p.m. the administrator stated P2's primary care provider should have been notified of the missed visits and missed Gentamicin bladder treatments, but had not been. The agency had been having trouble staffing P2's home due to the hours P2 wishes the nurse to be there and it only being a 6 hour shift. In addition, one of P2's regular nurses had taken an extended vacation and they had not been able to replace the nurse.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on interview and document review the home health agency failed to provide a physician ordered treatment for 1 of 4 patients (P2) reviewed for conformance with physician orders. Findings include: P2 was admitted to the HHA on 10/21/19, with the most recent plan of care (POC) certification period of 5/29/21 to 7/28/21. The POC included the following diagnoses: urinary retention and quadriplegia (paralyzed in all four limbs). The POC included, skilled nursing up to 6 hours/day for 60 days due to increased urinary retention and straight catheterization (a catheter inserted into the bladder to drain urine)needs. P2 was a 34 year old man and used an electric wheelchair for mobility. The POC identified P2 required an antibiotic, Gentamicin solution 480 milligrams (mg)/liter of 0.9% normal saline (NS) compound. Instill 60 milliliters (ml) into the bladder every night at bedtime. This solution was used to treat or prevent difficult urinary tract infections (UTI's). Certification periods 3/29/21 to 5/29/21, 1/29/21 to 3/29/21, 11/30/20 to 1/29/21 and 10/1/20 to 11/30/20 included the order for the Gentamicin to be instilled in the bladder daily. During a phone interview on 6/22/21, at 8:30 a.m. registered nurse care coordinator at the University of Minnesota Fairview Hospital (RN)-F stated P2 had been admitted to the hospital on 6/13/21, with a UTI. P2 required daily Gentamicin irrigations of the bladder to prevent UTI's. P2 had told RN-F he had only 5 RN visits for the bladder irrigation in the past two weeks prior to this hospitalization for a UTI. RN-F reached RN-A at Olidia Care, however, RN-A was not able to reassure her the agency would have the availability for an RN to visit P2 daily as ordered for the Gentamicin bladder irrigations. P2 had declined being admitted to a transitional care unit or a skilled nursing facility until the agency could meet his needs. P2 did not want his wife to have to learn and complete the bladder irrigations due to having several small children at home. However, P2 had agreed to have his wife learn this until the agency could provide his needs as ordered. RN-A was able to reassure RN-F a nurse would come to P2's home and teach his wife how to complete the bladder irrigations on 6/14/21, when he was discharged from the hospital, in case the agency was unable to provide the service daily. During an interview on 6/22/21, at 10 a.m. RN-A stated she had spoken to RN-F on 6/14/21, and assured her there would be a nurse to complete the 6/14/21, visit and teach P2's wife how to instill the Gentamicin as ordered. However, RN-F discovered there was no nurse available to complete the 6/14/21 visit. RN-F stated no one had completed the visit and arrangements had not been made to teach P2's wife. During an interview on 6/22/21, at 9:30 a.m. licensed practical nurse (LPN)-D stated she had worked with P2 on 6/15/21 and 6/16/21 and the agency had not directed her to teach P2's wife how to instill the Gentamicin into P2's bladder, nor had P2 asked her to. During a phone interview on 6/17/21, at 11:00 a.m. P2 stated he required a straight catheterization every 4 hours to empty his bladder and at night he is to have an antibiotic (Gentamicin) instilled into the bladder to prevent infections. This had helped prevent UTI's with him having a UTI about every 6 months while on the Gentamicin, versus about every 2 months prior. However, in the past 6 months, he has had 3 UTI's. The agency had been unable to send a nurse daily as ordered. P2 stated, "Every month it has been getting worse. Right now it is worse. Right now I am supposed to have medication in the bladder every night and when they don't come then I don't get the medicine. I have had more infections when I don't get the medicine." During a phone interview on 6/21/21, at 10:34 a.m. P2 clarified he has a patient care aide (PCA) from another agency who stays with him from 12:00 a.m. until 9:00 a.m. The PCA's had not been trained to do the Gentamicin irrigations and were not qualified to do so. P2 reported his wife was not able to perform the bladder irrigations as she must provide care to their 4 young children in addition to providing his care when no nurse or PCA is present. P2's nurse visit records identified the following missed visits and missed Gentamicin bladder treatments. June 2021-12 visits missed (1,4,5,6,7,8,10,11,14,18,19,20 ). Hospital 6/13/21 to 6/14/21). Reviewed through 6/20/21. May 2021-21 missed visits (2,3,4,7,8,9,11,13,14,16,17,18,20,21,22,23,25,26,28,30,31). April 2021-19 missed visits (2,3,4,5,6,9,10,11,12,13,17,18,19,20,23,24,25,27,30). March 2021-12 missed visits (1,2,3,4,5,6,23,25,27,28,29,30) (hospitalized from 3/7 through 3/17). February 2021-12 missed visits (1,2,5,6,7,11,12,15,16,22,25,26). January 2021-11 missed visits (1,8,9,10,14,15,17,22,24,28,29). December 2020-7 missed visits (3,4,13,15,25,30,31). November 2020-8 missed visits (1,4,10,12,14,15,27,29) (Hospital 11/16 to 11/26) October 2020-10 missed visits (6,7,8,11,12,14,18,22,26,31). During a phone interview on 6/17/21, at 9:17 a.m. RN-A stated the agency had difficulty providing a nurse for P2 as he required a 6 hour shift, from 6:00 p.m. until 12:00 a.m. Staff worked in other homes and could not be available at those specific hours. RN-A stated P2 often did not have the Gentamicin instilled in his bladder as ordered because they simply could not provide the staff. The agency did not have any kind of back up plan for P2 to receive the ordered treatment. RN-A had not reported the missed doses of Gentamicin the P2's primary physician or urologist. During a phone interview on 6/22/21, at 3:23 p.m. the administrator stated he had visited P2, "The root of the problem is staffing. [P2] is very specific on the hours he wants staffed by the nurses and adamant that he does not want his spouse to do the antibiotic bladder irrigations." The administrator stated P2's primary care provider should have been notified of the missed visits and missed Gentamicin bladder treatments, but had not been. Medication Management Program, undated, page 14, Medication Errors (includes medication dose omitted) directs: When an actual or potential medication error occurs, the prescribing physician/licensed independent practitioner and Olidia Care are to be notified immediately by the clinical staff member who identifies the error. An Incident Report is to be completed and forwarded to Administration. Documentation will include the name and dose of the drug, patient's response, time of physician notification and any orders received. Actual or potential medication errors will be tracked and trended as part of the performance improvement activities of the Olidia Care. Summary reports of findings, conclusions, actions taken and recommendations for improvement will be generated by the Performance Improvement department/Committee. Summary reports are submitted to the Professional Advisory committee and/or Board of Directors.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and document review, the home health agencies (HHA) administrator failed to provide day to day operations of the agency to ensure proper staffing for 4 of 5 patients (P1, P5, P4, and P2) reviewed for staffing. In addition, the agency failed to have a qualified clinical manager for oversight of patient care in order to meet the patients needs as outlined in their plan of care (POC). Based on interview and document review, the home health agencies (HHA) administrator failed to provide day to day operations of the agency to ensure proper staffing for 4 of 5 patients (P1, P5, P4, and P2) reviewed for staffing. In addition, the agency failed to have a qualified clinical manager for oversight of patient care in order to meet the patients needs as outlined in their plan of care (POC). Findings include: During interview 6/15/21, at 11:25 a.m. registered nurse (RN)-A stated she became the nurse manager on 11/3/20, and upon hire she never received a job description and the training she received was provided on the computer. RN-A stated she did receive training from another RN case manager who showed what should be done and how to accept a new patient and, "then I was on my own." RN-A stated she had been a nurse a little over a year and felt she did not receive proper training for her position and had asked several times for her job description and had never received one. RN-A stated the agency is currently having staffing issues and there was a recent incident where a patient (P1) was left for 3 hours without a nurse due to staffing issues. She indicated P1 was ventilator dependant and occasionally required manual ventilation with an Ambu bag that the nurse needs to provide. RN-A stated she was never taught the need to report allegations of abuse/neglect immediately and had never been given any power to suspend staff pending investigation, nor had she been given the responsibility to investigate allegations of abuse/neglect. During interview 6/15/21, at 1:10 p.m. with the administrator who stated he was made aware of the incident of the patient being left alone for 3 hours the following morning and RN-A reported it immediately. The administrator stated he did not feel the nurse who arrived in the evening after the patient was left alone needed to report the incident since no one would be available in the state agency to take the report. Even though all allegations of abuse and neglect must be reported to the state agency (SA) the HHA failed to follow this. In addition, the administrator stated in regards to RN-A he does not micro-manage and he is not a clinician and he counts on his nurse managers to follow through with all nursing related decisions. The administrator provided the nurse case manager job description and when asked if this was provided to RN-A, administrator provided a "no" response. During interview 6/15/21, at 6:08 p.m. staffing coordinator (SC) stated staffing is a challenge for the agency. The SC stated they have a lot of call ins, some call in only an hour before the start of their shift and in cases, staff are stuck staying with a client and work 24 hours. During interview 6/15/21, at 7:40 p.m. RN-B stated there is a problem with staffing with the agency and, "I have children and it is very difficult for me when a staff member does not show up and I am stuck working sixteen to eighteen hours and then have to go home and take care of my children that is where the problem comes for me." During interview 6/16/21, at 7:35 a.m. RN-L stated she has serious concerns with the staffing at the agency. She stated she had recently worked 32 hours because there was no staff for a patient. RN-L stated the administrator is aware and there is nothing being done about it. RN-L stated, "We are told to call 911 and have the patients sent to the hospital, but my patient refuses to go to the hospital so I am left with nothing else but to stay. It is not safe to work these kind of hours. This has been going on for over six months and I just don't think they care and there is no feed back or communication when we address our concerns to the administrator or management." During interview 6/16/21, at 12:44 p.m. administrator stated he is aware the agency has staffing issues and sometimes they have to count on the family to assist if there is no staff or they just might have to call 911 and have them sent to the hospital for cares. The administrator further stated they have four patients tonight that need 24 hour care they are trying to staff and some might need to be sent to the hospital for cares. During interview 6/17/21, at 9:20 a.m. RN-A stated the administrator recently wanted her to accept a new patient (P5) that required 24 nursing care and she declined due to staffing issues. RN-A stated he did accept the patient. RN-A stated, she had reviewed their policy book and a care manager should work in a home health for 3 years, but stated she was new to working in home care and did not know what all of her duties included. Management does not respond to her requests for direction. During interview 6/17/21, at 1:37 p.m. with P5's Health Partners Case Manager (CM)-A stated she spoke with the administrator on 5/6/21, and was promised the agency would be able to provide 24 hour coverage for P5 and they would be out to start the services. The CM-A stated she never heard back from him after 5/6/21, and she had called, sent emails and the administrator never responded to her. The CM-A further stated she was not even aware staff were going out to the home except from finding out from P5's spouse. During interview 6/17/21, at 4:36 p.m. the administrator stated P5 is not a current patient but he has had two nurses out there for a meet and greet to see if it would work out and plans to accept the patient but not for 24 hour care a day due to staffing. The administrator stated he has not contacted Health Partners yet. During interview 6/17/21, at 2:46 p.m. human resource assistant (HR)-B stated she used to do hiring of office assistance and was responsible for posting the help wanted adds for the agency and two months ago was told to stop posting openings for the nurses on indeed due to the high cost. The HR-B stated the communication on staffing is not good, they used to have weekly Zoom calls and that stopped, and when she tries to reach the administrator he is unavailable and in fact has not been able to reach him for two weeks. During interview 6/19/21, at 9:07 a.m. with family member (FM) -A, who is P4's family member, stated the agency is short of nurses and her spouse is supposed to receive 12 hours of care a day, 7 days a week. FM-A stated this does not happen and she has never agreed to be the back up for staffing but is often the person for the back up. In addition, she stated she is not even being notified if a nurse will not be arriving. FM-A stated she had called the administrator over a month ago with her concern and he has never returned her call and the communication with the agency is really bad. During a phone interview on 6/17/21, at 11:00 a.m. P2 stated he is supposed to receive daily visits from a skilled nurse from the agency. He is paralyzed and needs a treatment to his bladder to prevent urinary track infections. He has been hospitalized three times in the past 6 months with an infection and feels it has to do with not getting the treatment as ordered. During a phone interview on 6/17/21, at 9:17 a.m. RN-A stated the agency had difficulty providing a nurse for P2 as he required a 6 hour shift, from 6:00 p.m. until 12:00 a.m. Staff worked in other homes and could not be available at those specific hours. RN-A stated P2 often did not have the Gentamicin instilled in his bladder as ordered because they simply could not provide the staff. RN-A verified P2 had 58 missed visits in the past 3 months. During a phone interview on 6/22/21, at 3:23 p.m. the administrator stated the agency had been having trouble staffing P2's home due to the hours P2 wishes the nurse to be there and it only being a 6 hour shift. In addition, one of P2's regular nurses had taken an extended vacation and they had not been able to replace the nurse.

An abbreviated survey was conducted at Olidia Care Inc. on 5/10/21, through 5/12/21 to investigate complaints. As a result Olidia Care Inc was found not in compliance with requirements at 42 CFR Part 484, requirements for Home Health Agencies. The following complaint was found to be UNSUBSTANTIATED: MN00072627/H8154007C The following complaint was found to be SUBSTANTIATED: MN00072367/H8154008C

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to ensure provision of 12-hour awake care and treatment for 1 of 1 patient (P1). P1 failed to receive appropriate care which included turning/repositioning reviewed whose nurse was a sleep. Findings include: P1 plan of care (POC) for the certification period 4/28/21, through 6/28/21 indicated P1 was admitted to the HHA on 10/18/16, with diagnoses which included: spinal muscular atrophy, chronic respiratory failure with tracheostomy (an incision in the windpipe made to relieve an obstruction to breathing), use of a gastrostomy tube (a tube inserted through the abdomen that delivers nutrition directly to the stomach) and quadriplegia. The POC indicated P1 required skilled nursing assessment/monitoring and intervention, home care nursing 12 hours/day (7:00 p.m. to 7:00 a.m.) up to 24 hours per day, 7 days a week. In addition, the POC directed staff to provide turning and repositioning every 2 hours and as needed (PRN) while in bed due to at risk for skin breakdown related to low weight and immobility. Report submitted to the State Agency on 4/29/21, by the agency registered nurse (RN)-A case manager, indicated RN-A was informed of the incident by another nurse from another Agency providing services to P1, that on 4/28/21 around 4:00 a.m. P1 woke up and found RN-B sleeping in his room. P1 was yelling for RN-B to wake up and help P1 as the alarm was going off on P1's feeding pump. The feeding tube was empty, and RN-B needed to put more food in the tube and if it (feeding pump) malfunctioned went through the tube air it would not be good for P1. P1 kept yelling and a family member (FM)-A heard P1 yelling and went to help P1. FM-A went into the P1's room and woke up RN-B. During review of the agency Client Complaint Form dated 4/28/21, completed by RN-A indicated RN-C, who worked for another agency that cared for P1, called RN-A on 4/28/21, at 2:00 p.m. and reported FM-A had complained the overnight staff who had worked the previous night was asleep during the shift and could not her P1 calling for help to be repositioned and for the feeding pump which was alarming to be attended to. RN-A indicated FM-A was called by P1 using his phone and FM-A came to P1's room and woke up caregiver who then attended to P1. Also, the form indicated P1 corroborated the story and stated RN-B had stated he was not asleep but was listening to music with his ears plugged and could not hear P1 calling to be repositioned. In addition, the form indicated RN-B had indicated he had repositioned P1 an hour before the incident and that P1's feeding pump was malfunctioning and would sometimes beep for no reason. During interview on 5/12/21, at 11:30 a.m. RN-A case manager stated she received the report of the allegation on 4/28/21, from RN-C. RN-A stated she then had called FM-A the same day to follow up however, FM-A did not return her call until later on 4/28/21. RN-A stated on 4/28/21, she had called P1 to follow up on the allegation and P1 had stated to her he wanted to be repositioned but RN-B was not responding so he used the phone to call FM-A who came and woke up RN-B. RN-A stated P1 had also indicated the feeding pump was peeping at the time. RN-A stated "We immediately suspended the nurse and we invited him to the office for questioning and that was when he said he was not sleeping, he had a earpiece and did not hear the patient calling. He said the feeding pump peeps even when there is nothing wrong with it and he assumed it was malfunctioning. He said because P1 sleep talks when he heard him call, he thought that he was sleeping talking. He also said he had repositioned [P1] an hour before and did not expect him to call within a short amount of time." During interview on 5/12/21, at 12:16 p.m. RN-B stated he had assisted P1 into bed on 4/27/21, with assistance of family around 11:00 p.m. and had started the feeding tube. RN-B stated at around 12:00 a.m. P1 had requested to be repositioned and then at 2:00 a.m. RN-A stated he had set his alarm to reposition P1 at 4:00 p.m. because P1 was to be repositioned every 2 hours and as needed. RN-B stated "I was in the same room with [P1] downstairs, was sitting in the couch and at 3:00 a.m. [FM-A] came in and turned the light on in the room FM-A told me [P1] called me and I did not hear him. I put on this music on and I use the earpiece to help me stay alert. I told [FM-A] I was sorry." RN-B stated because the feeding tube machine malfunctioned and would go off here and RN-B acknowledged he never went to check to trouble shoot the feeding machine. RN-B stated although P1 was not dependent on a ventilator P1 had a tracheostomy and was not able to assist himself due to being immobile. RN-B stated using the earpiece caused him not to meet P1's needs immediately was not appropriate. During interview on 5/12/21, at 12:50 p.m. P1 stated "I called him and he was not waking up so I called [FM-A] she came downstairs and she turned the light on and after like 2 to 5 seconds he woke up. He said he was listening to the music." P1 stated he had reported the allegation to the other agency nurse who cared for him on 4/28/21, in the morning. During interview on 5/12/21, at 1:25 p.m. RN-A stated following the incident, she had asked other agency nurses who worked with P1's and RN-B and they had indicated RN-B used a earpiece. RN-A stated she was not sure if RN-B was asleep or due to using the earpiece he was not able to hear P1 calling for assistance. RN-A stated during an interview with RN-B, she had informed RN-B moving forward RN-B would not be scheduled for the overnight shifts and was not allowed to use the earpiece while caring for patients. RN-A stated using earpiece devices was against the agency policy and if being used, the staff was not able to hear what was going on with the patient, surrounding areas and this would compromise the patient safety which included but not limited to respiratory distress. RN-A stated, "if he had respiratory distress it would have been not good." During interview on 5/12/21, at 3:30 p.m. RN-C stated he had received a report of the allegation from RN-D on 4/28/21, who worked for his agency. RN-C stated P1 had indicated to RN-D, that RN-B had been sleeping and was wearing earbuds that previous night on 4/28/21, and he had attempted to call him to reposition him but RN-B did not respond. RN-C stated P1 had indicated he had called FM-A who came downstairs and FM-A had to shake RN-B on the shoulder to wake him up. P1 had also indicated he had been calling for assistance because the feeding tube was alarming for a while. The Agency's undated Child Abuse and Neglect policy directed staff to provide care, treatment and services in a manner that respects and fosters in patients/family members/caregivers a sense of dignity, positive self-regard, civil rights and involvement in their care and services. In addition, the policy directed staff to ensure that patients human, civil, constitutional and statutory rights were respected and not violated.

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure an incident on neglect was reported immediately to the State Agency (SA) for one of one patient (P1) reviewed, whose nurse was sleeping during the provision of required 12-hour awake care. Findings Include: P1 plan of care (POC) for the certification period 4/28/21, through 6/28/21 indicated P1 was admitted to the HHA on 10/18/16, with diagnoses which included: spinal muscular atrophy, chronic respiratory failure with tracheostomy (an incision in the windpipe made to relieve an obstruction to breathing), use of a gastrostomy tube (a tube inserted through the abdomen that delivers nutrition directly to the stomach) and quadriplegia. The POC indicated P1 required skilled nursing assessment/monitoring and intervention, home care nursing 12 hours/day (7:00 p.m. to 7:00 a.m.) up to 24 hours per day, 7 days a week. In addition, the POC directed staff to provide turning and repositioning every 2 hours and as needed (PRN) while in bed due to at risk for skin breakdown related to low weight and immobility. Report submitted to the State Agency on 4/29/21, by the agency registered nurse (RN)-A case manager, indicated RN-A was informed of the incident by another Agency nurse providing services to P1, that on 4/28/21 around 4:00 a.m. P1 woke up and found RN-B sleeping in P1's room. P1 was yelling for RN-B to wake up and help P1 as the alarm was going off on P1's feeding pump. The feeding tube was empty, and RN-B needed to put more food in the tube and if it (feeding pump) malfunctioned and air went through the tube air would not be good for P1. P1 kept yelling and a family member (FM)-A heard P1 yelling and went to help P1. FM-A went into the P1's room and woke up RN-B. The agency Client Complaint Form dated 4/28/21, indicated, RN-C who worked for another agency providing services to P1 called and reported to RN-A on 4/28/21, at about 2:00 p.m. that FM-A had complained the overnight staff who had worked the previous night was asleep during the shift. The form indicated RN-B could not hear P1 calling for help to be repositioned and for the feeding pump which was alarming to be attended to. RN-A indicated FM-A was called by P1 using his phone and FM-A came to P1's room and woke up caregiver (RN-B) who then attended to P1. Also, the form indicated P1 corroborated the incident and stated RN-B had stated he was not a sleep, but was listening to music with his ears plugged and could not hear P1 calling to be repositioned. During interview on 5/12/21, at 11:30 a.m. RN-A, case manager stated she received the report of the allegation on 4/28/21, from RN-C. RN-A stated she then had called FM-A the same day to follow up however, FM-A did not return her call until later on 4/28/21. RN-A then stated she did not report the allegation of potential neglect to the State Agency until 4/29/21, in the afternoon because she thought the vulnerable adult reporting line was closed for the day and she also needed to have a conversation with the agency administrator before reporting. RN-A stated on 4/28/21, she had called P1 to follow up on the allegation and P1 had stated to her he wanted to be repositioned but RN-B was not responding so he used the phone to call FM-A who came and woke up RN-B. RN-A stated P1 had also indicated the feeding pump was beeping at the time. RN-A stated RN-B had been suspended immediately suspended and was interviewed about the allegation. During interview on 5/12/21, at 12:50 p.m. P1 stated "I called him and he was not waking up so I called [FM-A] she came downstairs and she turned the light on and after like 2 to 5 seconds he woke up. He said he was listening to the music." P1 stated he had reported the allegation to the other agency nurse who cared for him on 4/28/21, in the morning. During interview on 5/12/21, at 1:25 p.m. RN-A stated any suspected allegation of abuse or neglect was to be reported within 24 hours. RN-A stated using ear piece devices was against the agency policy and RN-A stated using earpiece devices was against the agency policy and if being used, the staff was not able to hear what was going on with the patient, surrounding areas and this would compromise the patient safety which included but not limited to respiratory distress. RN-A stated, "if he had respiratory distress it would have been not good." During interview on 5/12/21, at 3:30 p.m. RN-C stated he had reported the allegation to RN-A on 4/28/21, between 10:00 a.m. and 11:00 a.m. about RN-B being a sleep when P1 required assistance and RN-A had indicated she was going to investigate the allegation. The Agency's undated Child Abuse and Neglect policy directed a person who knows or has reason to believe a child was being neglected or physically or sexually abused, was to report immediately the information to the local welfare agency, agency responsible for assessing or investigating the report, police department, county sheriff and tribal social services agency.

A COVID-19 Focused Infection Control survey was conducted on 12/30/20 to 1/4/21 at your facility by the Minnesota Department of Health to determine compliance with Emergency Preparedness regulations §483.73(b)(6). The facility was IN full compliance with this regulation.

An abbreviated survey was conducted at Olidia Care Inc. on 12/30/20 through 1/4/21 to investigate a complaint. Olidia Care Inc. is not in compliance with requirements at 42 CFR Part 484, requirements for Home Health Agencies. In addition, a COVID-19 Focused Infection Control survey was conducted 12/30/20 through 1/4/21, at your agency by the Minnesota Department of Health to determine compliance with §418.60 Infection Control. The agency was not in compliance. Complaint Substantiated: H8154005C-MN68235

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the agency failed to follow the Centers for Disease Control and Prevention (CDC) and Minnesota Department of Health (MDH) recommendations for screening visitors/staff for COVID-19 and failed to utilize appropriate eye protection when caring for 2 of 2 patients (P1,P2) reviewed for infection Control practice related to COVID-19 requirements. Findings include: P1's Home Health Certification and Plan of Care dated 11/21/2020 to 1/19/2021. Including diagnosis Acute hypoxic respiratory failure (low oxygen), and Tracheostomy (Surgical opening in the trachea (windpipe) for breathing), gastromstomy status (Surgical opening through the skin of abdomen to the stomach). 24 hour complex RN/LPN PDN daily 7 day/week. Client will receiving physical therapy (PT), occupational therapy (OT), and speech therapy. Functional limitations: Unable to ambulate, unable to speak, and incontinent of bowel and bladder. During interview on 12/29/20, family member (FM)-A stated that she entered P1's home in November and was not screened by any staff member and was in the house for over an hour and no staff approached FM-B to screen or ask to wear a mask. During observation at P1's home on 12/30/20, at 10:45 a.m. Minnesota Departement of Health staff (MDH) entered home. Registered nurse (RN)-A took my temperature and asked to wash hands. No other screening conducted. Two staff members were in the home and wearing mask only. One staff answered the door and the other staff was sitting at the table in the kitchen by computer. No patients present. During interview on 12/30/20, at 11:01 a.m. RN-A stated face shields or goggles are only worn if client is suspected or confirmed positive for COVID-19. During interview on 12/30/20, at 11:17 a.m. license practical nurse (LPN)-A stated staff do not wear goggles unless providing direct cares to the patient. LPN-A further stated that any visitors entering the home are to be screened for COVID by checking symptoms, temperature, sanitizing hands, and wearing a mask. During observation on 12/30/20, at 11:31 a.m. RN-B entered P1's room wearing face mask and no eye protection. RN-B educated P1 about suctioning his trach. RN-B cleansed hands, applied surgical gloves and then provided suctioning to trach. P2's Home Health Certification and Plan of Care dated 12/20/20 to 2/17/2021. Including diagnosis Acute respiratory failure with hypoxia (unable to breath on own), tracheostomy, developmental academic disorders, gastrostomy tube, lung disease, cerebral palsy, seizures, and agitation. Orders: 24 hour complex RN/LPN PDN 7 days week x 60 days. Functional limitations: legally blind, unable to ambulate, can not speak, incontinent of bowel and bladder. During observation on 12/30/20, at 11:40 a.m. RN-A was in P2's room providing repositioning. RN-A has mask on but no eye protection. During observation on 12/30/20, at 2:00 p.m. RN-A and RN-B were in R1's room sanitized hands, applied gloves and educated R1 on repositioning and asked permission to perform skin check. R1 gave thumbs up. RN-A and RN-B both had mask on but no eye protection. RN-A and RN-B rolled R1 from side to side. RN-B removed used gloves, sanitized hands and educated R1 that she was going to suction his trach. R1 gave a thumbs up. RN-B applied sterile gloves and suctioned patient. No eye protection on. During interview on 12/30/20, at 2:15 p.m. RN-C stated all staff are expected to be screened and to screen any visitors entering the home. The staff should check temperatures, wash hands and questions should be asked about signs or symptoms of COVID. Anyone entering the home should be wearing a mask. RN-C stated it is not acceptable if they did not fully screen visitors entering the home and all staff should know this as they have been educated multiple times. RN-C denied any staff or clients with COVID at this time. RN-C stated staff are not wearing face shields all the time, but should wear them when they are suctioning clients to prevent from getting splashed. During observation on 12/30/20, at 3:12 P1 was coughing thick mucous. MDH staff requested RN-B to come assist R1. RN-B stated "I have suctioned him all day". RN-B grabbed supplies sanitized hands, applied sterile gloves. RN-B suctioned P1 three times wearing only a mask. RN-B put supplies in trash can, removed gloves and then washed hands with soap and water. During interview on 12/31/20, at 7:51 a.m. FM-B stated when she has gone into the home staff did not check her temperature or ask any questions about COVID and is concerned about this. During interview on 12/31/20, at 10:30 a.m. RN-D stated all staff are suppose to wear face shield to protect there eyes. RN-D further stated all visitors and staff should be screened prior to entering the home with temperature checks, sanitizing hands and asking COVID symptom questions. During interview on 12/31/20, at 11:53 a.m. occupational therapist stated that she was not being screened by staff when she enters the home. Stated she does her own screening prior to entering the home and logs this with her employer but still not sure why they don't screen her. During interview on 12/31/20, at 3:10 p.m. speech therapist stated that she has been out to the house at lest 8 times since R1's arrival and only has been screened for COVID once or twice. During interview on 1/4/20, at 8:32 RN-E stated she wears a mask and eye protection anytime she is in a clients home. During interview on 1/4/20, at 8:52 a.m. administrator stated visitors are limited at this time and staff should be taking temperatures, having them sanitize their hands, and asking about signs and symptoms of COVID. If staff are not doing this, it is a problem. The administrated further stated that being screened by temperature only is not good enough and all visitors should be fully screened to try and prevent COVID from entering the home. He also stated that he was unaware of the eye protection recommendations from the CDC until MDH staff arrived, and that they are in the process of implementing this in all their homes. In addition the Administrator stated staff are currently wearing eye protection if they have been exposed to someone with COVID, or when in contact with suspected or confirmed COVID positive and placed on 14 day quarantine, that they have no confirmed COVID at this time and that they follow the CDC guidelines. Policy undated, Olidia Care COVID-19 Emergency and Action Plan indicated "All clients family members or visitors must be screened before entering the facility. The nurse on duty will check their temperature, travel history and other symptoms." Policy requested for guidelines for PPE. Facility did not provide Olidias own guidelines. The agency did provide CDC QSO-guideline from 3/10/20.