Sefertt Health Care LLC

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on observation, interview, and record review the home health agency (HHA) failed to provide a reasonable expectation for use of call lights for 4 of 4 patient (P1, P2, P3, P4) reviewed for assistance. P2 had to knock on her wall to call for assistance, P3 yelled out for assistance and P4 had no way of calling for assistance. P1 recently received a touch call button on her own following an incident at the home. Findings include: P1’s Home Health Plan of Care and Certification dated 7/10/25- 9/7/25 indicated P1 received skilled nursing for a frequency and duration of 24 hour extended care daily for 60 days, 2 hours of patient care assistant (PCA) daily for 60 days. Skilled nursing was to assess and evaluate all body systems as part of her care plan, provide tracheostomy (a direct opening in the neck to allow a tube to be inserted providing an airway), gastrostomy tube (an insertion of a feeding tube through the abdominal wall directly in to the stomach)and ventilator (life support machine that helps patients breathe when they are unable to do so on their own) care along with assisting in all activities of daily living. P1’s pertinent diagnoses were chronic respiratory failure, amyotrophic lateral sclerosis (Lou Gehrig’s disease, a nervous system disease that weakens muscles and impacts physical function), dependent on respirator, and major depression disorder. P1’s functional limitations were paralysis, endurance, ambulation, contractures, and speech. Mental status was oriented. Activities included transferring from bed to chair, prescribed exercises, and a wheelchair. Upon observation and interview on 8/21/25 at 9:59 a.m. P1 was seated in her specialized wheelchair in the commons area of the home. She was breathing through her ventilator using her Dynavox (a speech generating device in which P1 used her eyes to generate the device to speak). She stated she had an incident at the agency where her tracheostomy tube fell out and it took several minutes for the staff to respond. Following the incident P1 met with a speech therapist and got assistance with getting a touch call button that she can slightly move with her feet to call for staff assistance. She asked for the call button because of her anxiety from the incident when tracheostomy tube falling out and she was “tired” of using her Dynavox to reach out to staff as they could not always hear it from her room. P2’s Home Health Plan of Care and Certification dated 5/26/25 to 7/25/25 indicated P2 received skilled nursing for a frequency of 24 hours extended care daily for 60 days. P2’s pertinent diagnoses were acute and chronic respiratory failure, hemiplegia (weakness on one side of her body) following cerebral infarct (stroke), affecting the left nondominant side, and chronic obstruction pulmonary disease. Skilled nursing assessed and evaluated the management of P2’s airway, tracheostomy status, pain control, administered tube feedings through her gastrostomy tube and assess her integumentary status. P2’s functional limitations were bowel and bladder incontinence, paralysis, endurance, and ambulation. P2’s mental status was oriented and agitated. P2’s activities permitted were complete bedrest, transfer from bed to chair, prescribed exercises, and wheelchair. Upon observation and interview on 8/21/25 at 2:45 p.m. P2 was in bed. P2 could not speak, however could make her needs met by mouthing the words. P2 stated to call for help she knocked on her wall when she required staff assistance. P2 stated staff could not hear her knocking on the wall, but during the day when P1 was in the living room P1 would use her Dynavox machine to notify staff when P2 required assistance. P2 had never been offered a call bell of any kind. P3’s Home Health plan of Care and Certification dated 7/22/5 – 9/19/25 indicated P3 received skilled nursing for a frequency of 24 hours extended care daily and a patient care assistant for 4 hours daily for 60 days. Nursing to assess and implement cares per plan of care, assess skin, respiratory status, neurological and mental health, pain, safety, nutrition, and elimination, maintain ventilatory and provide all nursing cares. P1’s pertinent diagnoses were acute and chronic respiratory failure, quadriplegia (paralysis of all four limbs and torso), neurogenic bowel (nerve damage disrupting the bowel leading to bowel control concerns), tracheostomy status, colostomy status (opening in the abdomen allowing stool to be collected in the pouch), and dependence of respiratory status. P3’s functional limitations were paralysis and ambulation. Activities permitted were prescribed exercises and wheelchair. Mental status was oriented and depressed. Upon observation and interview on 8/25/25 at 1:12 p.m. P3 was lying flat in his bed, he had his cell phone attached to a bar above his head. He used his tongue to scroll on his phone. He stated when he required assistance he would yell. He would yell loud enough to get staffs attention, however sometimes it took a “while.” He stated If he needed, he could use phone to call the home and ask for staff. P3 denied ever being asked for another way to notify staff of when he required assistance. P4’s Home Health Plan of Care and Certification dated 7/6/25 – 9/3/25 indicated P4 received skilled nursing for a frequency of 24 hours extended care daily for 60 days. Skilled nursing assessed and provided all medical cares and activities of daily living. Assessed skin integrity, respiratory, neuro, elimination, safety, and musculoskeletal, pain gastrointestinal and nutritional status. Provided Foley indwelling catheter changes monthly. Administered tube feedings daily and maintained gastrotomy tube and jejunostomy tubes. P4’s pertinent diagnoses were anoxic brain damage, chronic respiratory failure, convulsions, anxiety, dysphagia (difficulty swallowing) and muscle spasms. Functional limitations were bowel and bladder incontinence, contractures, paralysis, endurance, and ambulation. Activities permitted were a wheelchair. P4’s mental status was oriented and forgetful. Upon observation and interview on 8/21/25 at 9:00 a.m. P4 was laying in his bed, his arms were contracture and bent at the elbows with his hands by his face. He could move his eyes and make small gestures with his mouth. R4’s family member (FM)-A was with him at his bedside. She stated his arms were also in the contracture position and he would not be able to call for assistance. FM-A stated that was one of the reasons she spent most of her days with him. Upon interview on 8/21/25 at 12:45 p.m. registered nurse (RN)-A stated P1 now has a way to call for staff since she has the touch alarm she used with her foot. P2 used the wall to knock and verified P1 often will notify staff when P2 is knocking on her wall. P3 yells out of his room, and he was close to the kitchen, allowing staff hears him. P4 was unable to call for help, staff needed to check on him often. Upon interview on 8/26/25 at 3:30 p.m. the clinical manager (CM) stated she was aware P1 got herself a touch alarm. The agency had given P2 a call light in the past and P2 did not use the light, so the agency removed it. P3 yelled for help and P4 was able to use a call light. A policy regarding client communication notification was requested however none was received.”

“Protect patient during investigation CFR(s): 484.50(e)(1)(iii) (iii) Take action to prevent further potential violations, including retaliation, while the complaint is being investigated. This Element is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to conduct a thorough investigation for 1 of 1 patient (P1) reviewed. The agencies investigation did not provide a resolution of the complaint. P1’s was ventilator dependent and ordered to have skilled nursing 24-hours a day. On 8/8/25 7:46 a.m. P1’s ventilator alarm sounded for eight minutes and three seconds because her tubing fell out leaving her without oxygen. Findings include: P1’s Home Health Plan of Care and Certification dated 7/10/25- 9/7/25 indicated P1 received skilled nursing for a frequency and duration of 24 hour extended care daily for 60 days, 2 hours of patient care assistant (PCA) daily for 60 days. Skilled nursing was to assess and evaluate all body systems as part of her care plan, provide tracheostomy (a direct opening in the neck to allow a tube to be inserted providing an airway), gastrostomy tube (an insertion of a feeding tube through the abdominal wall directly in to the stomach)and ventilator (life support machine that helps patients breathe when they are unable to do so on their own) care along with assisting in all activities of daily living. P1’s pertinent diagnoses were chronic respiratory failure, amyotrophic lateral sclerosis (Lou Gehrig’s disease, a nervous system disease that weakens muscles and impacts physical function), dependent on respirator, and major depression disorder. P1’sa functional limitations were paralysis, endurance, ambulation, contractures, and speech. Mental status was oriented. Activities included transferring from bed to chair, prescribed exercises, and a wheelchair. An incident note dated 8/8/25 by registered nurse (RN)-B indicated she arrived at 7:00 a.m. and received report from the night nurse who stated P1 had been suctioned more than usual. P1’s alarm triggered at 7:30 a.m. and RN-B suctioned her and got a small amount of clear secretions. A personal care attendant (PCA)-A arrived at 7:45 a.m. when RN-B was preparing medications for P1. RN-B asked PCA-A to listen for P1’s alarm and notify her of concerns. Before RN-B finished the medications with P1, PCA-A informed RN-B that P1’s alarm was sounding. RN-B immediately connected the tubing back in place and suctioned P1. P1 was then breathing o.k. and not in any distress. By the time she finished the other two members had arrived. RN-B did not indicate the time the alarm sounded or the time she reconnected. In later interview RN-B stated RN-C had been in the house, just using the bathroom in the basement. A facility schedule dated 8/8/25 indicated RN-B, RN-C and RN-D were scheduled to work at the home from 7:00 a.m. to 7:00 p.m. The schedule did not indicate which nurse was assigned to which client. P1’s timesheet dated 8/8/25 indicated RN-D arrived at 8:10 on 8/8/25. P1 sent an email message on 8/8/25 indicating she needed camera footage for the morning of 8/8/25 because took the nurse ten minutes to respond to her ventilator alarm. P1 was responded to immediately via email, but unable to send the camera footage due to the writers location. Writer explained what the footage covered at the time and investigation conducted immediately. Staff explained how the P1’s alarm went off and PCA-A called RN-B from another client’s room and responded immediately. RN-B was instructed to write an incident report. P1’s Patient Communication Log dated 8/8/25 indicated at 10:30 a.m. the DON called P1 to ask if she felt safe in the home until the writer returned from vacation P1 stated she was but was upset that the nurse did not tell other staff what took place. P1’s nurse (uncertain which nurse) explained that she had been having issues with her tracheostomy and the respiratory therapist (RT) had been called to check all the ventilator settings. P1 was encouraged to have the staff change her tracheostomy tubing which she agreed to allow staff to change later in the afternoon. Writer would follow-up later. P1’s Patient Communication Log dated 8/8/25 indicated the DON called P1 back at 4:00 p.m. Staff stated the tracheostomy change was successful and P1 was doing o.k. P1 also sent a text message at 4:08 p.m. indicated tracheostomy had been changed and everything was o.k. now. The DON instructed the nurse in question to make sure the report was filled out and in P1’s chart until the writer got back from vacation. An email from P1 to the clinical manager, her county case worker and the DON dated 8/8/25 at 1:28 p.m. Indicated R1 was inquiring if the staff notified the HHA leadership about the incident. The body of the email indicated P1 was in dire need of help. There was only one nurse in the home the time of the incident (RN)-B. A couple of minutes before 8:00 a.m. at 7:58, P1’s ventilator popped off. She had thick secretions blocking the top of the airway. RN-B was in P4’s room, passing meds. P1 was off the vent, airway blocked, barely able to breathe, for almost ten minutes. At 8:07 before RN-B arrived. P1 indicated, nothing was even passed on to the other staff when they arrived. No incident report, nothing. When RN-D asked RN-B about it, she only minimized it.” Arguing that there is no way it was as long, I might be off by 1 minute. Nobody had bothered to ask me how I am feeling, if I am OK, or even taken my vitals! Acting like it is no big deal when it is a life-threatening situation, says it all. If my trach cuff had not been leaking enough for me to get the tiny bit of air I got, I would not be typing this & there would be one hell of a lawsuit from my grieving family. It was all caught on camera. Will need a copy of that video footage & a copy of the formal incident report right away. Three to five business days should be more than adequate.” Upon interview on 8/21/25 at 9:59 a.m. P1 stated on 8/8/25 her ventilator tubing popped off, so she was not able to get much air, and it took eight minutes before the staff responded to her ventilator alarm sounding. P1 stated her cares were ordered to be twenty-four hours of skilled nursing every day. On 8/8/25 the nurse assigned to her had not shown up until 8:10 a.m. There was only one nurse in the house for three residents. P1 was later told that there was another nurse who was in the basement in the bathroom when her alarm was sounding. P1 stated she felt angry, depressed, and unheard because staff was telling she could not have been off the ventilator for eight minutes, that it was only about one minute. P1 stated she had her eyes on a clock the entire time she was fighting for air. Upon interview on 8/25/25 at 12:34 p.m. RN-D stated he was scheduled to work with P1 on 8/8/25 and did clock in at between 8:10 and 8:15 a.m. He stated RN-B reported the incident to him when he arrived. RN-E called the house and spoke with all the staff to obtain information about the incident. The DON instructed the staff the fill out an incident report. RN-D was not certain how long P1 was off the ventilator and had not heard from the agencies leadership since 8/8/25 about the investigation. Upon interview on 8/26/25 at 2:10 p.m. RN-B stated on 8/8/25 P1’s nurse was not onsite. She needed to care for P1, so she asked PCA-A to listen for P1’s are. She stated she was not certain of the time, “a little before 8:00 a.m.” PCA got her, and she responded immediately to P1’s alarm. She denied hearing the alarm from P4’s room. RN-B stated the DON reached out the staff a few times on 8/8/25 about P1’s staff. RN-B denied ever hearing how long P1 was off the ventilator or if there were any changes to staffing to ensure all client have the staff at the home. Upon interview on 8/26/25 at 3:26 p.m. the DON stated she conducted the investigation and made sure P1 was safe. She instructed staff to fill out an incident report and to change P1’s ventilator tubing. She denied finding out how long P1’s ventilator was alarming or how many staff were in the home. She denied following up with P1’s request to see the video monitoring taken in her room and denied finding a root cause why it took staff eight minutes and three seconds to respond. A facility policy titled Client; Family Complaint/Grievance Policy dated 2014 indicated clients of the agency are provided with written information and how to address their concerns related to their cares. The agency must maintain documentation of its efforts and demonstrate compliance with state requirement.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on observation, interview, and record review the home health agency (HHA) failed to conform with practitioner orders for the services for 4 of 4 (P1, P2, P3 and P4). P1, P2, P3, and P4 were all ordered to receive 24-hour extended skilled nursing services and the agency only staffed three nurses daily from 7:00 p.m. to 7:00 a.m. In addition, on 8/8/25 P1’s ventilator tubing fell out and it took staff eight minutes and three seconds to tend to her because her assigned nurse was not in the home. Based on observation, interview, and record review the home health agency (HHA) failed to conform with practitioner orders for the services for 4 of 4 patients (P1, P2, P3 and P4) reviewed. P1, P2, P3, and P4 were all ordered to receive 24-hour extended skilled nursing services and the agency only staffed three nurses daily from 7:00 p.m. to 7:00 a.m. In addition, on 8/8/25 P1’s ventilator tubing fell out and it took staff eight minutes and three seconds to tend to her because her assigned nurse was not in the home. Findings include: The agency staffing schedules reviewed for dates 7/1/25 to 8/31/25 for the Oakdale house where P1, P2, P3, and P4 reside indicated from daily from 7:00 a.m. to 7:00 p.m. four nursing staff were scheduled. From 7:00 p.m. to 7:00 a.m. only three nurses were scheduled. P1’s Home Health Plan of Care and Certification dated 7/10/25- 9/7/25 indicated P1 received skilled nursing for a frequency and duration of 24 hour extended care daily for 60 days, 2 hours of patient care assistant (PCA) daily for 60 days. Skilled nursing was to assess and evaluate all body systems as part of her care plan, provide tracheostomy (a direct opening in the neck to allow a tube to be inserted providing an airway), gastrostomy tube (an insertion of a feeding tube through the abdominal wall directly in to the stomach)and ventilator (life support machine that helps patients breathe when they are unable to do so on their own) care along with assisting in all activities of daily living. P1’s pertinent diagnoses were chronic respiratory failure, amyotrophic lateral sclerosis (Lou Gehrig’s disease, a nervous system disease that weakens muscles and impacts physical function), dependent on respirator, and major depression disorder. P1’s functional limitations were paralysis, endurance, ambulation, contractures, and speech. Mental status was oriented. Activities included transferring from bed to chair, prescribed exercises, and a wheelchair. P2’s Home Health Plan of Care and Certification dated 5/26/25 to 7/25/25 indicated P2 received skilled nursing for a frequency of 24 hours extended care daily for 60 days. P2’s pertinent diagnoses were acute and chronic respiratory failure, hemiplegia (weakness on one side of her body) following cerebral infarct (stroke), affecting the left nondominant side, and chronic obstruction pulmonary disease. Skilled nursing assessed and evaluated the management of P2’s airway, tracheostomy status, pain control, administered tube feedings through her gastrostomy tube and assess her integumentary status. P2’s functional limitations were bowel and bladder incontinence, paralysis, endurance, and ambulation. P2’s mental status was oriented and agitated. P2’s activities permitted were complete bedrest, transfer from bed to chair, prescribed exercises, and wheelchair. P3’s Home Health plan of Care and Certification dated 7/22/5 – 9/19/25 indicated P3 received skilled nursing for a frequency of 24 hours extended care daily and a patient care assistant for 4 hours daily for 60 days. Nursing to assess and implement cares per plan of care, assess skin, respiratory status, neurological and mental health, pain, safety, nutrition, and elimination, maintain ventilatory and provide all nursing cares. P1’s pertinent diagnoses were acute and chronic respiratory failure, quadriplegia (paralysis of all four limbs and torso), neurogenic bowel (nerve damage disrupting the bowel leading to bowel control concerns), tracheostomy status, colostomy status (opening in the abdomen allowing stool to be collected in the pouch), and dependence of respiratory status. P3’s functional limitations were paralysis and ambulation. Activities permitted were prescribed exercises and wheelchair. Mental status was oriented and depressed. P4’s Home Health Plan of Care and Certification dated 7/6/25 – 9/3/25 indicated P4 received skilled nursing for a frequency of 24 hours extended care daily for 60 days. Skilled nursing assessed and provided all medical cares and activities of daily living. Assessed skin integrity, respiratory, neuro, elimination, safety, and musculoskeletal, pain gastrointestinal and nutritional status. Provided Foley indwelling catheter changes monthly. Administered tube feedings daily and maintained gastrotomy tube and jejunostomy tubes. P4’s pertinent diagnoses were anoxic brain damage, chronic respiratory failure, convulsions, anxiety, dysphagia (difficulty swallowing) and muscle spasms. Functional limitations were bowel and bladder incontinence, contractures, paralysis, endurance, and ambulation. Activities permitted were a wheelchair. P4’s mental status was oriented and forgetful. An incident note dated 8/8/25 by registered nurse (RN)-B indicated she arrived at 7:00 a.m. and received report from the night nurse who stated P1 had been suctioned more than usual. P1’s alarm triggered at 7:30 a.m. and RN-B suctioned her and got a small amount of clear secretions. A personal care attendant (PCA)-A arrived at 7:45 a.m. when RN-B was preparing medications for P4. RN-B instructed PCA-A to listen for P1’s alarm and notify her of concerns. Before RN-B finished the medications with P4, PCA-A informed RN-B that P1’s alarm was sounding. RN-B immediately connected the tubing back in place and suctioned P1. P1 was then breathing o.k. and not in any distress. By the time she finished connecting tubing the other twos staff members had arrived. An email from P1 to the clinical manager, her county case worker, and the director of nursing (DON) dated 8/8/25 at 1:28 p.m. Indicated R1 was inquiring if the staff notified the agencies leadership. The body of the email indicated: P1 was in dire need of help. There was only one nurse in the home the time of the incident (RN)-B. A couple of minutes before 8:00 a.m. at 7:58, P1’s ventilator popped off. She had thick secretions blocking the top of the airway. RN-B was in P4’s room, passing meds. P1 was off the vent, airway blocked, barely able to breathe, for almost ten minutes. At 8:07 before RN-B arrived. Upon interview on 8/21/25 at 9:59 a.m. P1 stated on 8/8/25 her ventilator tubing popped off, so she was not able to get much air, and it took eight minutes before the staff responded to her ventilator alarm sounding. P1 stated her cares were ordered to be twenty-four hours of skilled nursing every day. On 8/8/25 the nurse assigned to her had not shown up until 8:10 a.m. There was only one nurse in the house for three residents. Upon interview on 8/25/25 at 10:18 a.m. P1’s county case manager stated P1 to be receiving one-to-one skilled nursing care twenty-fours a day. There was no shared nursing services ordered. P1 was very dependent and required constant supervision. Upon interview on 8/25/25 at 12:34 p.m. RN-D stated he was scheduled to work with P1 on 8/8/25 arrived at the house between 8:10 and 8:15 a.m. He stated RN-B reported the incident to him when he arrived. Upon interview on 8/25/25 at 3:58 p.m. RN-C stated he was in the house on 8/18/25 at 7:00 a.m., however he was using the bathroom in the basement of the home for 15-20 minutes when P1’s alarm sounded. He stated he heard the alarm for a minute and figured she had relieved assistance. RN-B was giving medications to the patient RN-C was scheduled to care for on the day of 8/8/25. Upon interview on 8/26/25 at 1:10 p.m. patient care assistant (PCA)-B stated on 8/8/25 he left the home following his shift a little after 7:00 a.m. and there was only one nurse in the home, RN-B. He stated he had never been asked to stay if the house was not fully staffed before leaving. Upon interview on 8/25/25 at 1:22 p.m. PCA-A stated she arrived at the house on 8/8/25 at 7:45 p.m. and the only nurse she saw was RN-B. She stated she was instructed to listen for P1’s alarm because her nurses had not arrived. She stated she heard the alarm after a few minutes after she was instructed to listen for it and immediate notified RN-B who was in the room in the back of the house. Upon interview on 8/25/25 at 4:47 p.m. P1’s medical provider stated eight minutes for a ventilator sounding was poor practice for a totally helpless patient who was ordered to have one-to-one nursing twenty-four hours a day. Leaving her unattended for that amount of time “is a problem.” Upon interview on 8/26/25 at 2:10 p.m. RN-B stated on 8/8/25 P1’s scheduled nurse was not onsite. She needed to care for P4, she instructed PCA-A to listen for P1’s alarm. She stated she was not certain of the time, “a little before 8:00 a.m.” PCA notified her, and she responded immediately to P1’s alarm. Upon observation and interview on 8/26/25 at 2:38 p.m. P1’s Respiratory Therapist (RT) ran the ventilator report from P1’s ventilator. The report revealed on 8/8/25 P1 was not hooked up to her ventilator for eight minutes and three seconds. Upon interview on 8/26/25 at 3:45 p.m. the director of nursing (DON) stated she aware that on 8/8/25 P1’s nurse was not in the home and the incident was investigated. She stated the reason they only staff three nurses from 7:00 p.m. until 7:00 a.m. was because up until 4/2025 P2 was not ordered to have twenty yet. The facilities Combined Federal and State Home Care Bills of Rights undated indicated the client had the right to receive all services outline in the plan of care.”

“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 four complex patients for 4 of 4 (P1, P2, P3, & P4) reviewed for staffing. Nursing staff were providing care and services up to and more than twenty-four 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 Based on observations, interview, and document review the agency failed to provide oversight of patient assignments for four complex patients for 4 of 4 patients (P1, P2, P3, & P4) reviewed. Nursing staff were providing care and services up to and more than twenty-four 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. Findings: The Office of the Revisor of Statutes dated 2024 reviewed 8/26/25 https.//www.revisor.mn.gov/statutes/cite/181.275 Sec. 181.275 MN Statutes indicated: Subdivision 1. Definitions. For purposes of this section, the following terms have the meanings given them: (1) “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; (2) “normal work period” means 12 or fewer consecutive hours consistent with a predetermined work shift. P1’s Home Health Plan of Care and Certification dated 7/10/25- 9/7/25 indicated P1 received skilled nursing for a frequency and duration of 24 hour extended care daily for 60 days, 2 hours of patient care assistant (PCA) daily for 60 days. Skilled nursing was to assess and evaluate all body systems as part of her care plan, provide tracheostomy (a direct opening in the neck to allow a tube to be inserted providing an airway), gastrostomy tube (an insertion of a feeding tube through the abdominal wall directly in to the stomach)and ventilator (life support machine that helps patients breathe when they are unable to do so on their own) care along with assisting in all activities of daily living. P1’s pertinent diagnoses were chronic respiratory failure, amyotrophic lateral sclerosis (Lou Gehrig’s disease, a nervous system disease that weakens muscles and impacts physical function), dependent on respirator, and major depression disorder. P1’s functional limitations were paralysis, endurance, ambulation, contractures, and speech. Mental status was oriented. Activities included transferring from bed to chair, prescribed exercises, and a wheelchair. P2’s Home Health Plan of Care and Certification dated 5/26/25 to 7/25/25 indicated P2 received skilled nursing for a frequency of 24 hours extended care daily for 60 days. P2’s pertinent diagnoses were acute and chronic respiratory failure, hemiplegia (weakness on one side of her body) following cerebral infarct (stroke), affecting the left nondominant side, and chronic obstruction pulmonary disease. Skilled nursing assessed and evaluated the management of P2’s airway, tracheostomy status, pain control, administered tube feedings through her gastrostomy tube and assess her integumentary status. P2’s functional limitations were bowel and bladder incontinence, paralysis, endurance, and ambulation. P2’s mental status was oriented and agitated. P2’s activities permitted were complete bedrest, transfer from bed to chair, prescribed exercises, and wheelchair. P3’s Home Health plan of Care and Certification dated 7/22/5 – 9/19/25 indicated P3 received skilled nursing for a frequency of 24 hours extended care daily and a patient care assistant for 4 hours daily for 60 days. Nursing to assess and implement cares per plan of care, assess skin, respiratory status, neurological and mental health, pain, safety, nutrition, and elimination, maintain ventilatory and provide all nursing cares. P1’s pertinent diagnoses were acute and chronic respiratory failure, quadriplegia (paralysis of all four limbs and torso), neurogenic bowel (nerve damage disrupting the bowel leading to bowel control concerns), tracheostomy status, colostomy status (opening in the abdomen allowing stool to be collected in the pouch), and dependence of respiratory status. P3’s functional limitations were paralysis and ambulation. Activities permitted were prescribed exercises and wheelchair. Mental status was oriented and depressed. P4’s Home Health Plan of Care and Certification dated 7/6/25 – 9/3/25 indicated P4 received skilled nursing for a frequency of 24 hours extended care daily for 60 days. Skilled nursing assessed and provided all medical cares and activities of daily living. Assessed skin integrity, respiratory, neuro, elimination, safety, and musculoskeletal, pain gastrointestinal and nutritional status. Provided Foley indwelling catheter changes monthly. Administered tube feedings daily and maintained gastrotomy tube and jejunostomy tubes. P4’s pertinent diagnoses were anoxic brain damage, chronic respiratory failure, convulsions, anxiety, dysphagia (difficulty swallowing) and muscle spasms. Functional limitations were bowel and bladder incontinence, contractures, paralysis, endurance, and ambulation. Activities permitted were a wheelchair. P4’s mental status was oriented and forgetful. The agency staffing schedule reviewed for dates 7/20/25 to 8/9/25 for the Oakdale house where P1, P2, P3, and P4 reside indicated RN-A, RN-B, and RN-C were consistently scheduled more than 12-hours in 24-hour period. On 7/20/25, RN-B was scheduled 7:00 a.m. through 7/22/25, 7:00 p.m. (60 total hours) On 7/22/25, RN- C was scheduled 7:00 p.m. through 7/24/25, 7:00 a.m. (36 total hours) On 7/28/25, RN-C was scheduled 7:00 a.m. through 7/31/25, 7:00 a.m. (60 total hours) On 7/28/25, RN-B was scheduled 7:00 a.m. through 7/29/25, 7:00 a.m. (36 total hours) On 8/3/25, RN-B was scheduled 7:00 a.m. through 8/5/25, 7:00 p.m. (60 total hours) On 8/8/25, RN-A was scheduled 7:00 a.m. through 8/10/25, 7:00 a.m. (60 total hours) Upon interview on 8/25/25 at 3:58 p.m. RN-C stated he is often scheduled for multiple shifts in a row. He stated he can take two hours in breaks every 12-hours. He stated at if he is working 36 hours he will save-up his break time and take 6 hours at once. He will go in the basement of the house and sleep or go to his car. He stated there was a schedule on to take breaks when multiple shifts were being worked at once. Upon interview on 8/26/25 at 2:10 p.m. RN-A verified the July and August schedules were correct and she is often scheduled for multiple shifts at time. She stated she will a two-hour break for every 12-hours she worked. She stated her breaks were not documented on the staff time sheet and breaks were not taken at any specific times. Upon interview on 8/26/25 at 3:30 p.m. the clinical manager stated she did not schedule the employees and was not certain of the regulatory requirements. The director of nursing (DON), the co-owner completed the schedules and handled all the payroll. The agency did not have a policy on staffing that the clinical manager was aware of. Upon interview on 8/26/25 at 3:45 p.m. the DON stated she was not aware that she could not schedule the staff for multiple shifts if they did not have a problem with it as long as they were taking ample breaks. A policy on staffing was requested however none was provided.”

“OASIS privacy notice CFR(s): 484.50(a)(1)(iii) (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. This Element is not met as evidenced by: Based on interview and document review the agency failed to provide the patient/legal representative the OASIS (Outcome and Assessment Information Set) privacy notice which is required under Federal Privacy Act for 3 of 3 patients (P1, P2 and P3) reviewed. Findings include: P1’s Admission Profile undated, indicated P1’s Start of Care was 2/27/24. Review of P1’s admission paperwork did not identify P1 or his legal representative received privacy notification for OASIS. P2’s Admission Profile undated, indicated P2’s Start of Care was 5/08/23. Review of P2’s admission paperwork indicated P2’s legal guardian was not informed of privacy notification for OASIS. P3’s Admission Profile undated, indicated P3’s Start of care was 10/30/23. Review of P3’s paperwork indicated P3’s legal guardian was not informed of privacy notification for OASIS. During interview on 6/24/24 at 1:00 p.m., clinical manager (CM) stated the OASIS privacy notification used to be in the patient’s admission packet and somehow when the previous office worker was at the agency and stopped putting the in the packet. The CM stated they will add them to the packets. Home Health Agency Outcome and Assessment Information Set (OASIS) Notice About Privacy revised 6/24, indicated as a home health patient, there a few things that you need to know about our collection of your personal health care information. Federal and State government oversee home health care to be sure that we furnish quality home health care services, and that you get quality Hom health care services. We need to ask you questions because we are required by law to collect health information to make sure that you get quality health care services. We will make your information anonymous. That way, the centers for Medicare & Medicaid Services, the federal agency that oversees this home health agency, cannot know that the information is about you.”

“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 P3) reviewed were offered to participate in the plan of care (POC) in receiving signed informed consent for audio/video monitors in their rooms. Findings include: P1’s POC with start of care 2/27/24 and certification period 5/10/24 to 7/08/24, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, bipolar disorder and was orientated with agitation and depression. The POC further indicated P1 lived in a congregate situation (e.g. assisted living). Availability assistance: around the clock. Patient Learning Preferences: Literal, Verbal instructions psychological status behavior: Anxiety, agitation, depression, difficulty coping with altered mental status. The POC further indicated P1 was homebound and required skilled nursing 24 hour extended care times 60 days. During interview on 6/20/24 at 9:36 a.m., P1 stated when admitted to the agency there was a monitor in his room and did not give permission for it. P1 stated he got upset and told the director of nursing (DON) sometime in May this year to have it removed because he felt it was a privacy right for him. P1 did state the DON did remove the monitor. P2’s POC with certification period 5/07/24 through 7/05/24, indicated P2 had acute respiratory failure, quadriplegia, neurogenic bowel, tracheostomy, anxiety disorder, and neuromuscular dysfunction of bladder. P2’s POC indicated skilled nursing services 24 hours for 60 days to eval and treat with all medical cares per orders and personal care assistant to assist with activities of daily living (ADL)’s four hours daily times 60 days. During observation on 6/20/24, at 10:00 a.m. an audio alarm was observed for P2 on the kitchen counter which was observed to hear P2 asking for staff assistance while in the home. P3’s POC with certification period 4/21/24 through 6/20/24, indicated P3 had seizure disorder, severe intellectual disabilities, generalized anxiety disorder and tracheostomy. P3’s POC further indicated he required vent as needed ongoing, and urinary ostomy with tube feeding. In addition to skilled nursing 24 hour extended care times 60 days for to assess and evaluation for all medical cares comprehensive assessment including, respiratory status, trach status, integumentary status, nutrition, elimination status and personal care assistance (PCA) four hours daily for 60 days. During interview on 6/21/24 at 9:36 a.m., the DON stated she received verbal consent from P1 for the monitor when he loses his voice and was complaining that when he calls no one hears, although when he stated he wanted it removed it was removed. The DON did state she has baby monitors in all the patient rooms and just received verbal consent and not signed consent. The DON stated P3 has an audio and video alarm that the parents have allowed with verbal consent and in the living areas there is audio and video cameras. The DON stated she did not have signed consent for the audio/video cameras and should have. During interview on 6/21/24 at 11:35 a.m. registered nurse (RN)-A stated P2 has an audio monitor in the home and P3 has an audio and video monitor that allows us to know if they need assistance while we are working in the home. RN-A stated only the DON has access to the video cameras in the home. A policy was requested but was not provided.”

“Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient’s caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (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 facility failed to thoroughly investigate an allegation of neglect and abuse for 1 of 1 patient (P1) reviewed who was observed to be drinking alcohol by staff and reported being spit on by a staff member. Findings include: P1’s POC with certification period 5/10/24 to 7/08/24, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, bipolar disorder and was orientated with agitation and depression. The POC further indicated P1 lived in a congregate situation (e.g., assisted living). Availability assistance: around the clock. Patient Learning Preferences: Literal, Verbal instructions psychological status behavior: Anxiety, agitation, depression, difficulty coping with altered mental status. The POC further indicated P1 was homebound and required skilled nursing 24 hour extended care times 60 days. P1’s POC indicated P1 received the following medications not limited to the : Oxycodone HCL (narcotic) oral tablet 5 milligrams (mg) three times daily as needed by G-Tub (gastrostomy tube) for moderate to severe pain, Valium (to treat anxiety, muscle spasms, and seizures) 2 mg 1 tablet four times daily by G-tube), Trazadone (antidepressant and sedative) 200 mg at bedtime to promote sleep, Gabapentin (used to treat seizures and nerve pain) 600 mg three times a day. During interview on 6/18/24 at 3:05 p.m., director of nursing (DON) stated P1 was receiving 24-hour skilled nursing services from there agency and has been with them since February 2024. The DON stated P1’s family member (FM)-A has been coming to his home and providing P1 with alcohol, getting him intoxicated and P1 has been having his friends over and drinking alcohol. The DON further stated he had accused a staff member of spitting in his face on 6/14/24, which she felt was not true and knows P1 spits in the staff’s face due to staff reporting this to her. The DON stated she did not file a report to the state agency. During interview on 6/20/24 at 2:30 p.m., registered nurse (RN)-B stated he arrived to work on 6/01/24 at 7:00 a.m. and P1 was in bed with slurred speech and FM-A and P1 were cursing at each other. RN-B stated he could see hard liquor bottle and beer cans in the room. RN-B further stated P1 demands to take his pain medications even though he has been drinking. During interview on 6/20/24 at 9:36 a.m., P1 stated a staff member at the agency had spit on my face and the DON is aware of it and I had sent a picture to her to prove it. P1 stated it was [Home Health Aide (HHA)-A] and they just ignore me about it. In addition, P1 stated my doctor knows I drink and said, “I can drink, and he said 100% I can drink it is okay”. In an interview on 6/24/24, at 12:00 p.m. the administrator stated a report was filed to the state agency regarding FM-A on 6/19/24, bringing alcohol to P1 on several occasions after the incident occurred on 6/01/24. During interview on 6/24/24 at 5:31 p.m., HHA-A stated he was working with P1 and was attempting to give P1 his pain medications and was bending over when P1 spit at him, was yelling and saying so many nasty things that I had to just leave the room. P1 then accused me of spitting on him. HHA-A stated P1 then called the police and they arrived at the home. After talking with me and P1 they left and said there was nothing they could do. HHA-A stated the DON was aware and knows I would never do that to P1. HHA-A stated he is working tonight with P1 and at times asks for him to work with him. During interview on 6/25/24 at 11:48 a.m., DON stated if she had to report every incident on P1 she would be making multiple reports daily, and just does not know what to do. In addition, the DON stated she did not complete an investigation on either incident since she did not report them. The agency Identifying and Reporting Abuse/Neglect/Exploitation of Clients policy undated indicated/ Complaint and Investigation Process: indicated the director of clinical services/designee will review the information presented and investigate to determine if this is a reportable incident. If so, the information will then be reported to the appropriate agency and maintain client confidentiality rights during the reporting and investigation process, as appropriate.”

“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 an allegation of neglect and abuse for 1 of 1 patient (P1) who was allowed to drink alcohol while taking narcotic medication P1 made an allegation of being spit on by a staff member personal care attendant (PCA-A). Findings include: P1’s POC with certification period 5/10/24 to 7/08/24, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, bipolar disorder and was orientated with agitation and depression. The POC further indicated P1 lived in a congregate situation (e.g., assisted living). Availability assistance: around the clock. Patient Learning Preferences: Literal, Verbal instructions psychological status behavior: Anxiety, agitation, depression, difficulty coping with altered mental status. The POC further indicated P1 was homebound and required skilled nursing 24 hour extended care times 60 days. P1’s POC indicatedP1 received the following medications not limited to the : Oxycodone HCL (narcotic) oral tablet 5 milligrams (mg) three times daily as needed by G-Tub (gastrostomy tube) for moderate to severe pain, Valium (to treat anxiety, muscle spasms, and seizures) 2 mg 1 tablet four times daily by G-tube), Trazadone (antidepressant and sedative) 200 mg at bedtime to promote sleep, Gabapentin (used to treat seizures and nerve pain) 600 mg three times a day. P1’s Abuse Prevention Plan: Vulnerability and Safety Assessment dated 5/10/24, indicated P1 refuses medical cares, wound care. Mother brings hard alcohol possibly street drugs to client. In addition, client swears and staff and spits on them, needs assist with all cares and has 24-hour cares with all medical cares and needs. During interview on 6/18/24 at 3:05 p.m., director of nursing (DON) stated P1 was receiving 24-hour skilled nursing services from there agency and has been with them since February 2024. The DON stated P1’s family member (FM)-A has been coming to his home and providing P1 with alcohol, getting him intoxicated and P1 has been having his friends over and drinking alcohol. The DON further stated he had accused a staff member of spitting in his face on 6/14/24, which she felt was not true and knows P1 spits in the staff’s face due to staff reporting this to her. The DON stated she did not file a report to the state agency. During interview on 6/20/24 at 2:30 p.m., registered nurse (RN)-B stated he arrived to work on 6/01/24 at 7:00 a.m. and P1 was in bed with slurred speech and FM-A and P1 were cursing at each other. RN-B stated he could see hard liquor bottle and beer cans in the room. RN-B further stated P1 demands to take his pain medications even though he has been drinking. During interview on 6/20/24 at 9:36 a.m., P1 stated a staff member at the agency had spit on my face and the DON is aware of it and I had sent a picture to her to prove it. P1 stated it was [Home Health Aide (HHA)-A] and they just ignore me about it. In addition, P1 stated my doctor knows I drink and said, “I can drink, and he said 100% I can drink it is okay”. In an interview on 6/24/24, at 12:00 p.m. the administrator stated a report was filed to the state agency regarding FM-A on 6/19/24, bringing alcohol to P1 on several occasions after the incident occurred on 6/01/24. During interview on 6/24/24 at 5:31 p.m., HHA-A stated he was working with P1 and was attempting to give P1 his pain medications and was bending over when P1 spit at him, was yelling and saying so many nasty things that I had to just leave the room. P1 then accused me of spitting on him. HHA-A stated P1 then called the police and they arrived at the home. After talking with me and P1 they left and said there was nothing they could do. HHA-A stated the DON was aware and knows I would never do that to P1. HHA-A stated he is working tonight with P1 and at times asks for him to work with him. During interview on 6/25/24 at 11:48 a.m., DON stated if she had to report every incident on P1 she would be making multiple reports daily, and just does not know what to do. In addition, the DON stated she did not complete an investigation on either incident since she did not report them. The agency Identifying and Reporting Abuse/Neglect/Exploitation of Clients policy undated indicated/ Complaint and Investigation Process: indicated the director of clinical services/designee will review the information presented and investigate to determine if this is a reportable incident. If so, the information will then be reported to the appropriate agency and maintain client confidentiality rights during the reporting and investigation process, as appropriate.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on interview and document review the agency failed to promptly notify the physician for 1 of 1 patient (P1) reviewed for providing additional pain medications without the physician’s prescribed order. Findings Include: P1’s POC with certification period 5/10/24 to 7/08/24, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, bipolar disorder and was orientated with agitation and depression. The POC further indicated P1 lived in a congregate situation (e.g., assisted living). Availability assistance: around the clock. Patient Learning Preferences: Literal, Verbal instructions psychological status behavior: Anxiety, agitation, depression, difficulty coping with altered mental status. The POC further indicated P1 was homebound and required skilled nursing 24 hour extended care times 60 days. P1’s POC indicated P1 received the following medications not limited to the : Oxycodone HCL (narcotic) oral tablet 5 milligrams (mg) three times daily as needed by G-Tub (gastrostomy tube) for moderate to severe pain, Valium (to treat anxiety, muscle spasms, and seizures) 2 mg 1 tablet four times daily by G-tube), Trazadone (antidepressant and sedative) 200 mg at bedtime to promote sleep, Gabapentin (used to treat seizures and nerve pain) 600 mg three times a day. In review of P1’s medication administration record (MAR) from 6/01/24 through 6/20/24, P1 received Oxycodone 5 mg as needed three times a day over the prescribed limit. On 6/01/24, 6/02,04, 6/05/24, 6/06/24, 6/07/24, 6/09/24, and 6/14/24. P1 received Oxycodone 5 mg’s four times. In addition, on 6/18/24, P1 received Oxycodone 5 mg five times. In review of P1’s medical record, there was no indication the physician was notified of giving extra dosages of the Oxycodone to P1. During interview on 6/24/25 at 2:45 p.m., clinical manager (CM) stated P1’s primary physician should have been notified of the extra dosages of Oxycodone medication he had received since it was ordered only three times a day as needed. During interview on 6/26/24 at 4:00 p.m., with P1’s primary physician (PP)-A stated he was unaware of the staff providing P1 extra dosages of his Oxycodone and is concerned of this since he also was not aware that he had been drinking to his extent. P1’s PP-A further stated he wants P1 to be seen by a pain clinic with concerns of his addiction of pain medication and was planning to reduce his dosage. The agencies Plan of Care Policy undated indicated, home care services are furnished under the supervision and direction of the client’s physician. The Plan of Care is based on a comprehensive assessment and information provided by the client/family and health team members. The plan will be consistently received to ensure that client needs will be updated as necessary, but at least every sixty (60) days. Signed Physician orders will be obtained as quickly as possible, and no claims will be sent prior to receiving signed orders when required by payer. Verbal/telephone orders shall be obtained from the client’s physician for changes in the Plan of care.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on observation and interview the agency failed to promptly alert the physician of changes in 1 of 1 patient (P1) reviewed for refusals in medications, treatments, and drinking. Findings include: P1’s POC with certification period 5/10/24 to 7/08/24, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, bipolar disorder and was orientated with agitation and depression. The POC further indicated P1 lived in a congregate situation (e.g., assisted living). Availability assistance: around the clock. Patient Learning Preferences: Literal, Verbal instructions psychological status behavior: Anxiety, agitation, depression, difficulty coping with altered mental status. The POC further indicated P1 was homebound and required skilled nursing 24 hour extended care times 60 days. P1’s POC indicated P1 received the following medications not limited to the : Oxycodone HCL (narcotic) oral tablet 5 milligrams (mg) three times daily as needed by G-Tub (gastrostomy tube) for moderate to severe pain, Valium (to treat anxiety, muscle spasms, and seizures) 2 mg 1 tablet four times daily by G-tube), Trazadone (antidepressant and sedative) 200 mg at bedtime to promote sleep, Gabapentin (used to treat seizures and nerve pain) 600 mg three times a day. Review of P1’s medication administration record (MAR) from 6/01/24 through 6/20/24 indicated the following for P1: -Suboxone (used to bridge addiction to Oxycodone) sublingual film 4-1 milligrams (mg) scheduled one film two times a day at 10:00 a.m. and 10:00 p.m. both dosages were refused by P1, on 6/03/24, 6/12/24, 6/14/24 and 6/15/24. -Evening treatment cares to all wounds twice daily cleanse with “Vashe and gauze. Apply a thin layer of critic aide paste to peri-wound, pack each wound with moisten kerlix gauze roll ensure to cover each wound bed, cover with ABD”. Was refused by P1, 17 out of 20 times on the evening shift. During interview on 6/24/24 at 3:00 p.m., clinical manager (CM) stated she understood how the physician should have been informed of all of the refusal’s of P1’s cares. During interview on 6/26/24 at 4:10 p.m., P1’s primary physician (PP)-A stated, he was not informed of P1’s refusals of all his cares. The agencies Plan of Care Policy undated indicated, home care services are furnished under the supervision and direction of the client’s physician. The Plan of Care is based on a comprehensive assessment and information provided by the client/family and health team members. The plan will be consistently received to ensure that client needs will be updated as necessary, but at least every sixty (60) days. Signed Physician orders will be obtained as quickly as possible, and no claims will be sent prior to receiving signed orders when required by payer. Verbal/telephone orders shall be obtained from the client’s physician for changes in the Plan of care.”

“Duties of a HH aide CFR(s): 484.80(g)(3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. This Element is not met as evidenced by: Based on interview and document review the home health agency was providing duties using a home health aide (HHA)-A that was not in their scope of practice in services to provide medication’s, treatments for 3 of 3 patients (P1, P2 and P3) reviewed who required medications that were unable to self-administer medications or ventilation, trach and gastrostomy (G-tube) treatments. Findings include: P1’s POC with certification period 5/10/24 to 7/08/24, indicated P1 was diagnosed with acute respiratory failure, quadriplegia, bipolar disorder and was orientated with agitation and depression. The POC further indicated P1 lived in a congregate situation (e.g., assisted living). Availability assistance: around the clock. Patient Learning Preferences: Literal, Verbal instructions psychological status behavior: Anxiety, agitation, depression, difficulty coping with altered mental status. The POC further indicated P1 was homebound and required skilled nursing 24 hour extended care times 60 days. P1’s POC indicated P1 received the following medications not limited to the : Oxycodone HCL (narcotic) oral tablet 5 milligrams (mg) three times daily as needed by G-Tub (gastrostomy tube) for moderate to severe pain, Valium (to treat anxiety, muscle spasms, and seizures) 2 mg 1 tablet four times daily by G-tube), Trazadone (antidepressant and sedative) 200 mg at bedtime to promote sleep, Gabapentin (used to treat seizures and nerve pain) 600 mg three times a day. The POC further indicated P1 received albuterol Sulfate inhalation solution 2.5 mg/3 milliliters (ml) four times daily for chronic respiratory failure, trach cares to (tracheostomy, help air and oxygen reach the lungs by creating an opening into the trachea (windpipe) from outside the neck) twice daily clean with normal saline, clean and secure stoma, clean all wound cares with Vashi and gauze and critic aide and paste to peri wound skin around each wound, pack with moisten kerlix gauze roll ensure to cover entire wound bed and cover with ABD. P2’s POC with certification period 5/07/24 through 7/05/24, indicated P2 had acute respiratory failure, quadriplegia, neurogenic bowel, tracheostomy, anxiety disorder, and neuromuscular dysfunction of bladder. P2’s POC indicated skilled nursing services 24 hours for 60 days to eval and treat with all medical cares per orders and personal care assistant to assist with activities of daily living (ADL)’s four hours daily times 60 days. P2’s POC indicated nebulizer every four hours if needed for cough, clean trach site with gauze and saline daily four times daily and tie as needed, trach suction per client request per client request every shift, make sure suction machine is plugged in every shift, empty canister at the end of every shift, clean and change Yankauer /Simms (oral suction tip and tubbing) ever shift, change trach and tube once a month with two staff. P3’s POC with certification period 4/21/24 through 6/20/24, indicated P3 had seizure disorder, severe intellectual disabilities, generalized anxiety disorder and tracheostomy. P3’s POC further indicated he required vent as needed ongoing, and urinary ostomy with tube feeding. In addition to skilled nursing 24 hour extended care times 60 days for to assess and evaluation for all medical care’s comprehensive assessment including, respiratory status, trach status, integumentary status, nutrition, elimination status and personal care assistance (PCA) four hours daily for 60 days. During interview on 6/24/24 at 5:31 p.m., home health aide (HHA)-A stated he provides more than personal care assistance (PCA) services to the patients at the Brooklyn Park home, and he can provide the same cares as the nurses at the home. HHA-A stated he had been trained to provide medications, g-tube care, ventilation and trach cares to all the patients at the home. A follow up interview on 6/25/24 at 9:00 a.m., with HHA-A stated he was trained by the agency to provide medications, and in addition took on-line classes by the agency for ventilation and trach cares. HHA-A stated there is always a nurse present when he gives medications, and they verify he is giving the correct medications prior to giving them. HHA-A stated he had been working for the agency since 2021 and had never had any errors or concerns. During interview on 6/25/24 at 9:48 a.m., the DON stated HHA-A was trained at the office to give medications and they partner with educare (on-line training program) then had HHA-A complete a skills test. The DON stated they only have HHA-A and HHA-B providing these services to the patients and felt this was okay since there is always a nurse in the home while they are giving medications and vent trach care to over see them. The agency policy Home Health Aide (HHA) Job Responsibility not dated indicated the home health aide enables clients to remain in their homes by monitoring and recording client condition, providing support and personal services such as bathing, grooming, grocery shopping, scheduling appointments, and notifies the nurse of changes in condition. The home health aide is to follow professional standards of federal requirements.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on interview and document review the agency failed to ensure home health aide (HHA) visits were supervised every 14 days for 4 of 4 patient (P1, P2, P3 and P4) reviewed for HHA services. Findings include: P1’s Plan of Care (POC) for certification period 5/10/24-7/08/24, indicated P1 had diagnoses of acute and chronic respiratory failure, bipolar disorder, pressure ulcers. P1 required skilled nursing services 24 hour extended care to assess and eval and assist with all medical cares per plan of care. P1’s POC lacked indication P1 received HHA services or what treatments or interventions were needed. P2’s POC with certification period 5/07/24 through 7/05/24, indicated P2 had acute respiratory failure, quadriplegia, neurogenic bowel, tracheostomy, anxiety disorder, and neuromuscular dysfunction of bladder. P2’s POC indicated skilled nursing services 24 hours for 60 days to eval and treat with all medical cares per orders and personal care assistant to assist with activities of daily living (ADL)’s four hours daily times 60 days. P3’s POC with certification period 4/21/24 through 6/20/24, indicated P3 had seizure disorder, severe intellectual disabilities, generalized anxiety disorder and tracheostomy. P3’s POC further indicated he required vent as needed ongoing, and urinary ostomy with tube feeding. In addition to skilled nursing 24 hour extended care times 60 days for to assess and evaluation for all medical care’s comprehensive assessment including, respiratory status, trach status, integumentary status, nutrition, elimination status and personal care assistance (PCA) four hours daily for 60 days. During interview on 6/24/24 at 5:31 p.m., home health aide (HHA)-A stated he provides more than personal care assistance (PCA) services to the patients at the Brooklyn Park home for P1, P2 and P3, and provides the same cares as the nurses do at the home. HHA-A stated he had been trained to provide medications, g-tube care, ventilation, and trach cares to all the patients at the home. During interview on 6/25/24 at 11:37 a.m. the director of nursing (DON) stated they do use the HHA’s to fill in to assist with medication passes and to complete treatments due to staffing issues and do not provide supervisory visits on HHA-A since there is always a nurse working with HHA-A and felt it was not necessary. The DON stated she was not aware the agency still needed to provide supervisory visits. In addition, the DON stated HHA-B also provides the same services in the home and has no record of supervisory visits for that staff member as well. P4’s POC with certification period 6/12/24 through 8/10/24, indicated P4 had diagnoses of chronic obstructive pulmonary disease, malignant neoplasm of the lung, urinary incontinence, and post-traumatic stress disorder. P4’s POC further indicated P4 received skilled nursing services weekly to assess and evaluation medication set up/management of medications and comprehensive assessment of all identified diagnoses teaching of disease process, and HHA four hours weekly to provide and assist with personal care and assistance with ADL’s. Review of HHA-C supervisory visits every 14 days indicated the following missed visits from 4/11/24 to 6/25/24: -missed supervisory visit on week of 4/22/24, 5/09/24, 5/23/24. During interview on 6/25/24 at 2:05 p.m., clinical manager (CM) stated she had seen P4 and forgot to complete the supervisory visit notes and should have for HHA-C. Agency policy Clinical Supervision undated, indicated when clients are receiving skilled nursing services in addition to personal care, the Registered Nurse will make a supervisory visit to the client’s residence no less frequently than every 14 days. The home health aide would not have to be present for these visits. Documentation will be reviewed on a continual basis either by chart audit or home visit.”

“EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: Based on interview and document review, the facility failed to address in their Emergency Preparedness Plan the patient population including, but not limited to, persons at-risk. This had the potential to affect all 33 current clients of the agency. The agency’s Emergency Preparedness Plan last reviewed 5/9/21, did not address patient population, including, but not limited to, persons at-risk; the type of services the agency had the ability to provide in an emergency; and continuity of operations. During interview on 1/4/24, at 10:14 a.m. the agency’s director of nursing (DON) verified the plan did not address population, including, but not limited to, persons at-risk; the type of services the agency had the ability to provide in an emergency.”

“Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: Based on interview and document review, the facility failed to address in their Emergency Preparedness Plan a policy on how the agency would utilize volunteers during an emergency. This had the potential to affect all 33 current patients of the agency. The agency’s Emergency Preparedness Plan last reviewed 5/9/21, did not have a policy for the usage of volunteers during an emergency. During interview on 1/4/24, at 10:14 a.m. the agency’s director of nursing (DON) verified that plan did not have a policy for the usage of volunteers during an emergency. She was not sure if the agency would use volunteers, but the DON reviewed the education policy and found a statement that volunteers would be educated the same as staff.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on interview and document review, the facility failed to address in their Emergency Preparedness Plan, tabletop disaster drills or active disaster drills. This had the potential to affect all 33 current patients of the agency. The agency’s Emergency Preparedness Plan last reviewed 5/9/21, failed to include evidence of tabletop emergency drills performed or live emergency drills performed along with the reviews of the drills. During interview on 1/4/24, at 10:14 a.m. the agency’s director of nursing (DON) stated the agency had not done tabletop drills or live emergency drills since 2020, when COVID-19 became a concern.”