Regency Home Healthcare Services, LLC

“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 interview and record review the home health agency (HHA) failed to inform and receive consent before taking 1 of 3 patients (P1) to the emergency room for observation and treatment reviewed for patient rights. Findings include: P1’s Certification and Plan of Care for certification period 6/11/26 – 8/9/26 indicated P1 required 24-hour skilled nursing visits per day for 60 days. P1’s diagnoses were spinal muscular atrophy and related syndromes (neuromuscular disorder that causes certain muscles to become weak and waste away), chronic respiratory failure (long term condition where lungs cannot properly taking enough oxygen or remove enough carbon dioxide), dependence of respirator (machine that controls breathing), tracheostomy status (surgical procedure that creates an opening in the neck) and anoxic brain damage (lack of oxygen to the brain). P1 was on complete bedrest and was nonverbal. P1’s provider’s notification note dated 6/8/26 at 10:00 p.m. indicated the agency sent a note on the providers portal indicating P1 was noted to have swelling in her left upper extremity from the shoulder down to her fingers, unsure if P1 was experiencing pain as P1 did not display any facial grimace when touched or when repositioned. In addition, P1 was on Heparin (blood thinner), and her syringes were on backorder, so she missed her dose p.m. dose of Heparin on 6/8/26. P1’s provider’s response notification note dated 6/8/26 at 10:21 p.m. the provider recommended to send P1 to the emergency room since she had missed a dose of heparin and had a history of blood clotting. P1’s nursing progress note dated 6/8/26 indicated P1 was sent to the hospital for an ultrasound and evaluation of the left upper extremity. There was no documentation for consent or notification to her guardian that P1 was transported to the emergency department. Text messaging correspondence between P1’s guardian and the HHA Administrator on 6/15/26 initiated by the Administrator indicated P1 was being sent to the emergency department due to a fractured arm found an x-ray ordered when provider visited P1 in the home and found her arm was still swollen. P1’s guardian asked for explanation to understand as she was not aware of any swelling and wanted to know who reported the incident and how a fracture was determined. The Administrator responded that she was investigating the situation. She indicated there was a report of P1’s arm being swollen a week prior and the doctor notified the night nurse to take her into the emergency department for an evaluation. That exam was negative. During a routine doctor’s appointment last week, the doctor decided to order an x-ray as P1’s arm as it was still swollen and reached out that P1 had a fracture and wanted her evaluated at the hospital again. P1’s guardian responded, indicating she had multiple questions and was upset and confused as to why she was not contacted of P1 having to go out to the emergency room or 6/8/26 with arm swelling. The Administrator responded verifying she did not blame the guardian for being upset and would keep her updated. Upon interview on 6/25/26 at 11:45 a.m. P1’s guardian stated she was not aware P1 had a concern about a swollen arm over a week prior to notification that P1 was in the hospital with a fracture. She stated she was waiting for an update from the agency as to how the fracture happened and P1 would remain in the hospital until she knew the root cause of the injury. Upon interview on 6/25/26 at 4:20 p.m. registered nurse (RN)-A stated she was the nurse who received the notification to send P1 to the emergency room on 6/8/26, however was not the nurse accompanying her. The night nurse, (RN)-B, went with P1. RN-A denied notifying P1’s family. Upon interview on 6/29/26 at 3:15 p.m. the Administrator stated the guardian’s notification was probably missed because the incident happened right at shift change in the home An attempt was made to reach out to RN-B, the night nurse, however no response was received. An HHA policy titled Client Cares indicated dated 4/14/26 indicated client/client responsible party responsibilities were to notify the provider of changes in conditions, however, did not indicate the responsibility of the agency in notification of changes in condition to the patient and/or guardian.”

“Condition of Participation: 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 484.50, Patient Rights. The HHA failed to ensure 1 of 1 patient (P1) was free from abuse when the agency was informed that Registered Nurse (RN)-A was physically abusive to P1. The Immediate Jeopardy (IJ) began on 12/1/25, when it was reported to the agency that registered nurse (RN)-A was physically abusive to patient (P1). The agency’s director of nursing (DON) was notified of the IJ on 12/8/25, at 2:44 p.m. The IJ was removed on 12/10/25, at 3:34 p.m., when it was verified, staff were trained on abuse, reporting and investigation of abuse. Findings include: Refer to G430: Based on observation, interview and document review, the home health agency (HHA) failed to ensure abuse did not occur for 1 of 1 patient (P1) who was physically, verbally sexual and emotionally abused on several occasions by registered nurse (RN)-A who was providing private duty nursing to P1. The abuse was viewed via video footage.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on documentation and interview, the facility failed to report all Outcome and Assessment Information Sets (OASIS) data collected in accordance with federal regulations. A review of the total number of records submitted beyond the 30 days between the dates of 1/1/25-12/18/25 was 840, which equaled 100% of submissions. Findings include: On the HHA Error Summary by Agency report period of 1/1/2025-12/8/2025, the agency had an error code of -3330: which identified a record submitted more than 30 days after completion of the new record. The total number of records submitted beyond the 30 days within that period was noted to be 840 out of 840 submissions, which equaled 100% of the submissions submitted. On 12/8//25 at 4:47 p.m., following receipt of information regarding the OASIS submission report, the administrator reached out in follow up. At that time, the administrator stated they had changed to a different provider for the electronic medical record in the past year. The administrator stated the OASIS reports were run monthly, and OASIS submissions were completed at that time. On 12/11/25 at 12:46 p.m., an interview was held with the director of nursing (DON) and the administrator. A review was completed regarding the current process and expectations regarding the submissions of the OASIS for review. Per both administrator, and DON, it was identified the reports run via their current EMR system would be increased to at least twice monthly to assure the OASIS submission was completed in a timely fashion. The Administrator stated there was not a separate agency policy for OASIS completion and submission. The agency followed the manual for OASIS from CMS (Centers for Medicare and Medicaid).”

“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 home health agency (HHA) failed to ensure abuse did not occur for 1 of 1 patient (P1) who was physically, verbally sexual and emotionally abused on several occasions by registered nurse (RN)-A who was providing private duty nursing to P1. The abuse was viewed via video footage. The Immediate Jeopardy (IJ) began on 12/1/25, when it was reported to the agency that registered nurse (RN)-A was physically abusive to patient (P1). The agency’s director of nursing (DON) was notified of the IJ on 12/8/25, at 2:44 p.m. The IJ was removed on 12/10/25, at 3:34 p.m., when it was verified, staff were trained on abuse, reporting and investigation of abuse. Findings include: P1’s plan of care (POC) with the start of care dated 10/3/25, indicated P1 had diagnoses of anoxic brain damage, persistent vegetive state, quadriplegia, contracture of muscle unspecified, tracheostomy status, and chronic respiratory failure with hypoxia. In addition, the POC indicated skilled nursing care 24 hours a day to administer medications, trach cares, G-J tube (soft tube that enters the stomach. G-tube in the stomach, J-tube is threaded to the small intestine) cares, nebulizer treatments, and cough assist. P1’s POC further indicated to administer medications water and feeding via j-tube. P1’s medical doctor (MD) orders directed nursing staff to do the following: - give Duo Neb (is a combination of two medications—albuterol and ipratropium—used together to help open the airways in the lungs) 0.5 milligram (mg) – 2.5 mg/3 milliliters (ml) inhalation solution. Give 3 ml nebulizer (is a medical device that turns liquid medicine into a fine mist, allowing it to be inhaled directly into the lungs to treat respiratory conditions) four times daily for respiratory health. -give Sodium chloride 3% inhalation solution (hypertonic saline to help thin and loosen thick mucus in the airways), inhale 4 ml neb, 4 times daily after DuoNeb’s. P1’s plan of care directed staff to: - Provide passive and assisted range of motion (AROM)- (when a caregiver moves a joint while the patient’s muscles remain completely relaxed) exercises twice a day according to MD orders. - Provide AROM every shift. P1’s Grievance form (Employee/Client) dated 12/1/25, indicated Grievant information identified P1, RN-A, business office manager (BOM) and DON were the involved parties and DON was the investigator. Date, time, and place of event leading to grievance indicated P1’s home on 11/28/25. Detailed account of occurrence indicated RN-A was on camera using excessive force for range of motion (ROM) and repositioning. Also concerns with hooking up g-tube and J-tube backwards. G-tube to vent and J-tube to feed due to aspiration risk caught by family member (FM)-A around midnight on 11/28/25. Results of the investigation identified P1 was evaluated in the emergency department (ED) on 12/1/25, after weekend with family monitoring, no hospital admission. Family does not want RN-A back as their nurse. DON went through counseling report with RN-A need for in person education on ROM with contractures, probationary period and importance of attention to detail regarding g versus Jtube connectors. Details of resolution indicated counseling report was reviewed and returned by RN-A. P1 home safely. RN-A will not return to P1’s home per family report. In person education mandatory period before offering RN-A other shifts at other locations. A Common Entry Point (CEP) Report dated 12/2/25, indicated an outside registered nurse (ORN) reported in the last few months P1 has had an unusual number of incidents requiring hospitalization (such as abdominal distension, flipped G-J tubes, and incorrectly administered medications) after RN-A’s work shifts. These incidents and the fact other Home Care nurses mentioned every time RN-A had a shift with P1 they needed to do additional cleanup and reposition P1 for comfort, prompted FM-A to set up video surveillance. FM-A sent ORN ten videos all taken on 11/28/25, showing RN-A being physically aggressive and abusive while providing care services to P1. The video footage included RN-A plugging P1’s nose during nebulizer treatments, slamming P1’s limbs down hard onto the bed, jamming P1’s limbs back and forth instead of properly stretching them, and slamming a large humidifier reservoir bag onto P1’s crotch in order to brace the urinal for use. In response to this evidence, FM-A contacted RN-A’s supervisor at Regency Home HealthCare and informed them RN-A will no longer be allowed in the home. An additional Common Entry Point (CEP) Report dated 12/2/25, indicated a hospital social worker (HSP) viewed video footage from FM-A that showed RN-A pushed P1’s leg down in an attempt to straighten it multiple times deliberately with extensive force (P1’s leg is contracted at baseline and unable to be straightened out due to medical conditions). In addition, it was reported that RN-A was seen pinching/plugging P1’s nose during nebulizer treatments. FM-A stated he reported to Regency Home Health Care about RN’s behavior and was told they will be doing an internal investigation. During a phone interview on 12/3/25, at 4:34 p.m., ORN stated FM-A had sent her videos with an explanation RN-A was physically and verbally abusing P1. ORN stated the videos were from a shift RN-A worked on 11/28/25. RN-A would cover P1’s face with a towel, while RN-A did things to P1. One of the things was pinching his nose while receiving a nebulizer treatment and P1’s cheeks would puff out while his face turned red. P1 had a severe leg contracture and RN-A can be seen holding the leg down. P1’s family brought P1 to the ED because he slept a straight 48 hours after RN-A last worked with him on 11/28/25. ORN stated she reported this to the DON on 12/4/25, after she had made the report to the state on 12/2/25. P1’s Video surveillance with date/time stamp for 11/28/25 starting at 6:38 a.m., was reviewed. P1 was lying in bed with the head of the bed up with a white hand towel over his head, noted to have a urinal between his legs with a large clear humidity bag laying over the top of it. P1’s left leg was lying over the edge of the bed on the left side and his left knee was bent in. At 6:39 a.m., RN-A was noted to grab a hold of P1’s left knee and lower leg and aggressively, with both hands, forcefully push P1’s leg outward and down several times and then hold his hands down on P1’s left knee with pressure. P1’s facial expression was not viewable as the towel was over his head. At 6:51 a.m., P1 was noted to be in the same position and had a nebulizer treatment hooked up to his trach. RN-A can be seen pinching P1’s nose with his left hand for 19 seconds while P1’s cheeks were puffing out and cheeks were turning red. During a phone interview on 12/4/25 at 9:47 a.m., outside licensed practical nurse (OLPN) stated she was familiar with RN-A and would sometimes take over care for P1 after RN-A worked with P1. OLPN stated at baseline P1 was non-verbal but will show signs of discomfort through facial grimacing. OLPN stated she previously witnessed RN-A plug P1’s nose while giving P1 a nebulizer treatment but could not remember what day exactly. OLPN stated the last time she took over care for P1, RN-A was yelling at P1 to go to sleep. FM-A showed OLPN the videos of what RN-A did to P1 and could not believe what she was seeing stating, “it was straight up abuse.” RN-A was pinching P1’s nose with his nebulizer treatments, forcefully pulling on his contracted limbs, yelling and swearing at him. OLPN stated she was surprised P1’s leg did not break due to his severe contractures in the leg and the amount of force RN-A used. During a phone interview on 12/4/25 at 11:20 a.m., FM-A stated RN-A had been working with P1 since January 2025, and they never had any problems until the last few weeks. FM-A stated P1 was completely dependent on staff for all activities of daily living (ADL)’s and was not verbal. FM-A stated a few weeks ago family had suspicions about what was happening with P1 due to so many emergency room visits and hospitalizations after RN-A would work. Family decided to set up cameras. FM-A stated he reviewed the footage on 11/28/25, he stated RN-A worked from 6:00 a.m., until family took over at 4:00 p.m. and found that RN-A would plug P1’s nose during his nebulizer treatments and then would look around as if to see if anyone was watching him. FM-A stated he also saw RN-A slam down hard on R1’s severely contracted left leg. “With the force he used on him I am surprised he didn’t break his hip.” FM-A stated P1 was incontinent of bladder, and you just need to check and change him every two hours, but noted in the video RN-A roughly placed a urinal and put P1’s “junk” in it and then placed a heavy humidity bag on it, “that had to hurt.” FM-A stated RN-A was seen putting a towel over P1’s head. FM-A stated he could not understand why RN-A would abuse P1 like he had witnessed in the video. During a phone interview on 12/4/25 at 12:53 p.m., RN-A stated he had worked with P1 since January of 2025, but had worked through the current agency for the last 4 months. RN-A stated P1 had an anoxic brain injury and was pretty much a vegetable meaning P1 was completely dependent on staff for all cares. RN-A stated P1 has severe contractures in all of his extremities but especially his left leg. RN-A further stated P1 does not have any voluntary movements other than blinking his eyes. RN-A stated he last worked with P1 on 11/28/25 from 6:00 a.m. until 4:00 p.m. RN-A stated DON called him on 12/1/25, and told him FM-A called about having a video of him being a little too forceful with PROM to P1’s left leg and said he was kind of pushing on P1’s left knee that was on video. RN-A stated he did use some excessive force but didn’t hear any cracking or anything further stating he would have stopped had he heard a single crackle or pop. RN-A stated DON did not talk to him about pinching P1’s nose but stated he normally pinched P1’s nose during nebulizer treatments because he wanted to make sure the nebulizer medication was getting into his lungs. RN-A stated, “that was my little trick.” RN-A stated if P1 was uncomfortable he will make facial grimacing such as when you suction his trach and you go in too deep. RN-A stated he does put a towel over P1’s head when he wants P1 to sleep. RN-A did admit, when he was using force on P1’s left leg the towel was over his head and RN-A would not be able to tell if this was uncomfortable for P1 due to not seeing any facial grimacing. RN-A stated he does use a urinal with P1 and placed it between P1’s legs and puts a humidity bag on top of it to hold it in place. RN-A didn’t think the rough edges, or the weight of the humidity bag would bother P1. The DON had told him he could come into the office for additional training and that he had not done so. During an interview on 12/4/25 at 1:28 p.m., DON stated on 11/30/25, the business office manager (BOM) sent me videos of the proof of abuse from FM-A with an explanation, RN-A was being reported for abuse against P1. DON stated he had fallen asleep and didn’t see the videos until 12/1/25 at 3:26 a.m. DON stated he reviewed the videos and found on 11/28/25 at 6:52 a.m., DON could see that RN-A put a towel over P1’s head and had his nebulizer running via P1’s trach and was noted to pinch P1’s nose for a few seconds during the nebulizer treatment. DON stated it was concerning to see RN-A do that and there would be no medical indication to ever do that with a patient and verified P1 would not be able to communicate whether it was uncomfortable or not. Regarding the video of RN-A pushing down on P1’s left leg, DON stated it was borderline abusive. DON stated he called RN-A to talk about the videos on 12/1/25, and RN-A stated to DON, this was about me pushing on P1’s knee, wasn’t it? DON stated he told RN-A it appeared he had used excessive force on P1’s left leg and RN-A agreed. RN-A then stated he would never do it again. DON stated he gave verbal education to RN-A on the phone on excessive force and told RN-A he would have to have mandatory in-service training before returning to care for any client. During an interview on 12/4/25 at 2:08 p.m., BOM stated she was first notified of P1’s physical abuse from RN-A via a text from FM-A on 11/30/25 at 10:20 p.m., he told me, “I am sorry to let you know that RN-A has been reported for abuse.” FM-A then sent me some videos of the abuse about a minute later. BOM stated she watched the videos and did not want to watch them again. BOM stated it was not appropriate at all what RN-A did to P1. BOM stated since it was an allegation of abuse, she immediately texted the information and the videos to DON after reviewing them. BOM had checked the schedule to make sure RN-A was not scheduled to work with any other clients that day. A facility reported incident (FRI) dated 12/8/25 at 3:35 p.m., indicated FM-A sent DON more videos that afternoon showing physical and verbal abuse of P1. After a call between this reporter [DON] and FM-A. FM-A stated that there are hundreds of videos over the course of 3 shifts that RN-A worked on 11/22/25, 11/26/25 and 11/28/25. Videos are extensive, but include footage of hitting, cussing, assumed penetration of P1’s rectum with a finger, improper range of motion exercises and equipment leading to pain and potential injury, improper respiratory treatment causing pain-if not respiratory infection. Abuse all caught on camera and all video footage has been submitted to the police per FM-A. DON called the police department to make sure they had the videos and were investigating and that was confirmed. DON did voice his concern to the police that the nurse in question does have multiple jobs, was unsure if RN-A will be working as a caregiver for anyone else currently or any time soon through another employer but that he would not want him to be working as a caregiver for anyone. Whether that means acting on an arrest or something else the police can do. Police contact that took the information said he would pass along that information. During an interview on 12/8/25, at 8:23 a.m., DON stated he received more videos from FM-A on 12/7/25, for the following dates: 11/22/25, 11/26/25 and 11/28/25 and correlated that RN-A did work these days. DON stated he reviewed some of the footage. DON stated the police had asked for a timeline of when RN-A was found to be abusing R1 and according to FM-A and the video footage DON had reviewed the abuse was ongoing on all three days to include swearing at P1 and banging P1’s head against the bed. DON stated RN-A had stated to P1, “you want me to put my finger up your butt?” and it looked like he did do that in the video. DON stated that the police told him this was an arrestable offense and that he had filed a report with the state on the new information that was received, RN-A was immediately terminated after the report was received and police were notified. DON stated he did not want RN-A working with any clients and police told him that RN-A will be arrested for sexual assault. P1’s Video surveillance date/time stamped for 11/22/25 from 7:35 p.m. until 8:24 p.m. was reviewed. While P1 was lying in bed with a brief on RN-A was noted to continuously physically abuse P1: using excessive force yanking on P1’s left leg with both hands to the point of P1 moving down further in the bed, roughly readjusting P1’s urinal that was placed between his legs with the humidity bag on top of it, roughly suctioning P1’s trach causing P1 to cough, gag and face to turn red and continuing to suction even though this was happening, using the same trach catheter to suction deep into P1’s mouth after roughly using a Toothette on the sides of P1’s teeth occurring at least 5 times consecutively, grabbed the top of P1’s hair holding P1’s head off the bed, before pulling P1 up in bed RN-A placed his hands under his back and shook P1 up and down causing the back of P1’s head to hit the bed continuously before moving up in bed and noted to pinch P1’s nose for seconds at a time while receiving nebulizer treatments. P1’s Video surveillance date/time stamped 11/26/25 at 5:30 a.m., P1 was lying in his bed with the head of the bed raised about 30 degrees with heated humidity connected to his trach. Lights were off in his room. RN-A was noted to be standing on the right side of P1’s bed and was noted to be wearing a head lamp. RN-A stated, “Do you want me to fucking stick my finger in your ass?” RN-A paused for about 7 seconds then stated, “fine I will.” RN-A’s back was to the camera and can be seen doing something between P1’s legs causing P1’s body to move back and forth for several seconds, while RN-A was doing this he turned his head to the left to look at P1. P1 had his eyes open. At 5:43 a.m., RN-A then grabbed the top of P1’s hair, lifted his head off the pillow while simultaneously stating, “close your eyes and go to fucking sleep.” During a phone interview on 12/11/25 at 10:00 a.m., FM-A stated we reviewed all of the videos from 11/22/25, 11/26/25 and 11/28/25, and RN-A was non-stop abusing P1. RN-A would ram the suction catheter down P1’s trach then use the same one to ram down his throat. He threatened to shove his finger up his ass then did it, he would use the cough assist machine over and over with him while plugging his nose for extended periods of time, while every last breath was being sucked out of him. FM-A further stated RN-A purposely put the feeding in his g-tube, between the excessive cough assist and the feeding in the tube we finally figured out why P1 was getting so much air in his stomach resulting in several unnecessary ED visits, laparoscopic surgeries and hospitalizations over the last year. FM-A stated this was attributed to the abuse P1 suffered from RN-A. FM-A stated from the abuse RN-A has inflicted upon P1, P1 now has severe PTSD, he hears another guys voice and he starts jumping and twitching. P1 hadn’t been sick like this until RN-A started working with him. FM-A stated RN-A was sucking the breath right out of P1 with that cough assist, then RN-A told P1 to, “smile you are on candid camera.” RN-A tortured him all night long, at one point he took P1’s nebulizer off put it up to his mouth and told P1 to, “take a hit of the weed.” On 11/26/25, he picked P1 up by his shoulders and shook him and told him to, “go to fucking sleep.” P1 does nothing but lay there, he did not deserve any of this. FM-A stated, “what the hell kind of nurse is he, he makes P1 sick then helps him then he is what, a hero?” During a phone interview on 12/9/25 at 10:50 a.m., RN-A verified he worked with P1 on 11/22/25, 11/26/25 and 11/28/25. RN-A admitted he used a toothette to swab the outside of P1’s teeth and had suctioned his mouth after using the same catheter in his trach. RN-A stated he had never noticed P1 exhibiting signs of pain when doing mouth care but did state P1 may gag or choke a little bit if he goes to deep with the suctioning of the trach and his mouth. RN-A stated for toileting, P1 does not know when he has to go to the bathroom. RN-A stated the urinal would have been put between his legs and humidity bag on top of that. “It was an optional way to toilet him.” RN-A stated,” I prefer to get his urine out that way so he is not laying in a saturated diaper.” RN-A stated there could be a potential problem for skin breakdown with placing that humidity bag on top of the urinal and stated he had never noticed any problems, nor did he think it would be uncomfortable for P1. RN-A admitted that P1 would not be able to communicate if something was uncomfortable, the only way to know would be if he exhibited facial grimacing. RN-A was asked if he ever picked P1’s head off the bed by grabbing the front of P1’s hair. RN-A laughed and stated he was seeing now how the family must be viewing his behavior as abusive towards P1. RN-A admitted he had pulled P1’s hair to lift his head off the bed stating, “it’s to get a better grip on his head in order to accomplish the task of putting a pillow behind him.” RN-A was asked if he ever stated to P1 at any time alluding to threatening to place his finger in P1’s rectum. RN-A stated he may have said something like this to P1 in order to elicit a smile. RN-A was asked if P1 ever smiled. RN-A stated no, “I wanted to see him smile once in a while, so I came up with that.” RN-A stated he had put his finger in P1’s rectum on two occasions and stated only to get a bowel movement but could not recall what dates he had done this. RN-A stated, “I might have sworn at him before when I have gotten frustrated with him. I have told him I would stick my finger in his ass, I don’t think he would ever understand that. I don’t know what he understands. I did not know that would be considered abuse to say that to someone. Now that we have discussed it boy-oh-boy, I do now.” RN-A stated he has plugged P1’s nose while doing the cough assist and his nebulizer treatments, he felt like the air does not escape intranasally and P1 would get better expansion in his lungs to do a better job. RN-A stated, “No one taught me that, I do it that way because it’s my own theoretical thinking.” RN-A stated he was terminated from the agency yesterday [12/8/25] for abuse to P1 through video evidence. RN-A stated some of the things he had done he didn’t realize they were considered abuse. RN-A stated he wished it would not have come to this and wished the family would have come to him with the things he was doing with P1 and just told me please do not do it anymore rather than directly off the bat being terminated. RN-A stated the things that he described to this surveyor were not on P1’s care plan and there were no MD orders to do things the way he did them. Facility policy, “Vulnerable Client,” reviewed 12/8/25, identified a purpose to 1. To protect individuals who, because of physical or mental disability or dependence on home health services, are particularly vulnerable to abuse or neglect. 2. To ensure a safe living environment for vulnerable individuals who are receiving services. 3. To identify within the client’s home all potential areas that might contribute to vulnerability and include corrective measures in the care plan. 4. To provide protection to individuals reporting abuse or neglect within the parameters of the law. 5. To ensure all mandated reporters understand when and how to report suspected abuse or concerns and to ensure proper reporting is being made immediately or as soon as possible… All reports will be internally investigated and reported to the common entry point immediately or as soon as possible… Abuse: 1. An act against a vulnerable adult that constitutes a violation of an attempt to violate, or aiding and abetting a violation of: a. assault in the first through fifth degrees b. the use of drugs to injure or facilitate crime. c. the solicitation, inducement, and promotion of prostitution d. criminal sexual conduct in the first through fifth degrees 2. Conduct which is not an accident or therapeutic conduct as defined in this section, which produces or could reasonably be expected to produce physical pain or injury or emotional distress including, but not limited to, the following: a. hitting, slapping, kicking, pinching, biting, or corporal punishment of a vulnerable adult. b. use of repeated or malicious oral, written, or gestured language toward a vulnerable adult or the treatment of a vulnerable adult which would be considered by a reasonable person to be disparaging, derogatory, humiliating, harassing, or threatening. c. use of any aversive or deprivation procedure, unreasonable confinement, or involuntary seclusion, including the forced separation of the vulnerable adult from other persons against the will of the vulnerable adult or the legal representative of the vulnerable adult; and d. Use of any aversive or deprivation procedures for persons with developmental disabilities or related. 3. Any sexual contact or penetration between a facility staff person or a person providing services in the facility and a resident, patient, or client of that facility. 4. The act of forcing, compelling, coercing, or enticing a vulnerable adult against the vulnerable adult’s will to perform services for the advantage of another… 11. If an employee is the suspected abuser, the employee is removed from the home and the supervisor investigates and determines WITHIN 24 HOURS either probable maltreatment, abuse, or neglect or not. The Immediate Jeopardy that began on 12/1/25, was removed on 12/10/25, when it was verified that staff were trained on reporting and taking action in response to allegations of abuse.”

“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 ensure physician ordered tube feeding was administered only as directed by the physician for 1 of 1 patient (P1) reviewed. Findings include: P1’s plan of care (POC) with the start of care dated 10/3/25, indicated P1 had diagnoses of anoxic brain damage, persistent vegetive state, quadriplegia, contracture of muscle unspecified, tracheostomy status, and chronic respiratory failure with hypoxia. In addition, the POC indicated skilled nursing care 24 hours a day to administer medications and gastro-jejunal tube (G/J) tube (a specialized feeding device that provides access to both the stomach (gastric) and the small intestine (jejunum) through a single opening in the abdomen). Gastric (G) Port: Connects to the stomach. It is primarily used for venting/decompression (releasing gas or air to relieve bloating) and draining stomach fluids). Jejunal (J) Port: Passes through the stomach and ends in the small intestine (jejunum). This port is used for feeding and hydration, as well as specific medications that must bypass the stomach) cares. P1’s POC further indicated to administer medications water and feeding via J-tube. P1’s MD orders dated 11/15/25, directed staff to leave G-port to continuous drain, do not rotate G/Jtube, Nutren 2.0 feeding, add one carton to bag every 6 hours, all tube feeding, water and medications go through J-tube. Goal rate 40 ml per hour, goal volume 960 ml. Skilled nurse to administer medications, feeding and water via j-tube. P1’s triage telephone encounter note dated 11/28/25 at 11:52 p.m., identified FM-A called with concerns of P1’s g/Jtube was mixed up and now P1’s gastric bag was filling 1100 ml (milliliters) within six to seven hours, heart rate and blood pressure were elevated, belly was not distended. FM-A reported RN-A had put the bags and lines on backwards resulting in P1 not receiving any of his medications or feed. P1’s food, medications and flushes went into the gastric tube and came out of the Jtube into the bag. FM-A had just discovered the error and switched it. P1 had symptoms of jerking and twitching due to myoclonus (sudden, brief, involuntary muscle twitches, jerks, or spasms). MD response was to start giving ½ doses of medications that he may have missed and if things do not improve bring P1 to the emergency department so that the tubes can be evaluated to make sure everything is flowing as it should be since there is a large amount of output in comparison to the intake. P1’s triage telephone encounter note dated 12/1/25 at 11:23 a.m., identified FM-A following up regarding triage call on 11/28/25, regarding RN-A mixing up Jtube and Gtube input with tube feed (Per FM-A this was caught on web camera, and P1 has been hospitalized other times while under this nurse’s care). P1 continued to have a lot of output. They started giving him water via jtube due to concern for dehydration. FM-A reported P1 has “been sleeping since Friday night.” Trach suctioned last night producing “thick brown goo.” FM-A was worried about aspiration pneumonia. FM-A recalled P1 in physical pain, evidenced by grimacing while asleep, restlessness, and moving his left leg/knee a lot. BP 95/60, pulse 83, O2 92-93% via trach-which was close to baseline. Temp 97.7 F, but had Tylenol. P1 was being monitored by nurse, which father reported was an LPN. The recommended disposition is go to ED now. FM-A drives truck and family member (FM)-B at work-wondering if ED can wait till this afternoon so they can be present. Explained risks of sepsis and life-threatening issues with delaying care-especially given his high complexity. FM-A agreeable, will contact FM-B and likely arrange ambulance transport. P1’s After Visit Summary (AVS) dated 12/1/25, identified P1 was seen for concern of aspiration. CT scan of abdomen and pelvis was reassuring and chest x-ray showed resolving pneumonia. P1’s Grievance form (Employee/Client) dated 12/1/25, indicated Grievant information identified P1, RN-A, business office manager (BOM) and DON were the involved parties and DON was the investigator. Date, time, and place of event leading to grievance indicated P1’s home on 11/28/25. Detailed account of occurrence indicated…concerns with RN-A hooking up G-tube and J-tube backwards. G-tube to vent and J-tube to feed due to aspiration risk caught by family member (FM)-A around midnight on 11/28/25. Results of the investigation identified P1 was evaluated in the emergency department (ED) on 12/1/25, after weekend with family monitoring, no hospital admission. Family does not want RN-A back as their nurse. DON went through counseling report with RN-A need for in person education on ROM with contractures, probationary period and importance of attention to detail regarding G versus J-tube connectors. Details of resolution indicated counseling report was reviewed and returned by RN-A. P1 home safely. RN-A will not return to P1’s home per family report. In person education mandatory period before offering RN-A other shifts at other locations. A Common Entry Point (CEP) Report dated 12/2/25, indicated an outside registered nurse (ORN) reported in the last few months P1 has had an unusual number of incidents requiring hospitalization (such as abdominal distension, flipped G-J tubes, and incorrectly administered medications) after registered nurse (RN)-A’s work shifts…Family member (FM)-A contacted Regency Home Healthcare services and informed them RN-A will no longer be allowed in P1’s home. An additional Common Entry Point (CEP) Report dated 12/2/25, indicated a hospital social worker (HSP) reported that P1 presented to the St. Mary’s Emergency Department due to his feeding tube was mismanaged; the Home health care staff switched his G and J tubes, resulting in feeding and medications being administered through the G-tube instead of the J-tube for approximately 10 to 15 hours. RN-A had last worked 11/28/25 at 4:00 p.m. Outside licensed practical nurse (OLPN) reported that RN-A had switched the P1’s J and G tubes (not sure if this was medical neglect/incompetence or targeted). OLPN stated that this was shown on video per family security cameras…FM-A noted the concerns for 11/28/25, that R1 had switched P1’s J and G tubes (not sure if this was medical neglect/incompetence or targeted). During a phone interview on 12/4/25 at 9:47 a.m., OLPN stated a typical day for P1 regarding his nutrition was to give the feeding, medications and water flushes through his J-tube. P1 has a bag hooked up to his G-tube, this was used for venting. OLPN stated in a typical 24-hour shift P1 will have approximately 325 ml (milliliters) output from his G-tube. OLPN stated RN-A was giving P1 extra water flushes. OLPN found a notebook where RN-A had been writing them down. P1 can only handle so much water. OLPN stated when P1 received his feeding his bed should be at least elevated to 30 degrees, when he lies flat, he has a hard time breathing and was more at risk for aspiration. On 11/28/25, RN-A hooked his feeding up to his G-tube and it resulted in P1 being to be sent to the ED to rule out aspiration pneumonia. During a phone interview on 12/4/25 at 11:20 a.m., FM-A stated RN-A worked until 4:00 p.m., on 11/28/25, and had hooked up P1’s feeding to the wrong tube, he hooked it up to his G-tube that was supposed to be used for only venting. FM-A stated we took over care at that time and we couldn’t figure out why P1’s gastric bag kept filling up like 100 ml every 15 minutes, in 5 hours it had filled up to 1200 ml. FM-A stated around midnight he called the hospital because he was worried about P1 being dehydrated and that’s when he noticed the lines were switched. FM-A stated RN-A had to have done that on purpose, the tube clearly states which one is the G-tube and which one is the J-tube. FM-A stated he reviewed the video footage and RN-A had switched the lines between 9:00 a.m. and 10:00 a.m. FM-A stated RN-A would have had to unscrew the bag from the gtube tube and directly hook that feeding tube into the G-tube. We did end up bringing P1 to the ED on 12/1/25, because the providers there wanted to rule out aspiration pneumonia and sepsis. During a phone interview on 12/4/25 at 12:53 p.m., RN-A stated P1 had orders to deliver all medications, feeding and water flushes through his J-tube and that there was a bag hooked up to his G-tube which is where gastric secretions and air went. RN-A admitted on 11/28/25, he was confused with the G/Jtube that day and kept switching them out and was unable to articulate why. RN-A stated, “I went with what I thought was correct.” RN-A stated the DON had called him and informed him that per video footage he had hooked it up wrong. RN-A stated the complications that can occur from this would be aspiration pneumonia. During an interview on 12/4/25 at 1:28 p.m., DON stated he received a complaint from FM-A on 12/1/25, that RN-A has switched P1’s G/Jtube, he hooked the feeding up to the G-tube instead of the J-tube and the drainage bag was hooked to the G-tube. DON stated RN-A was not following MD orders and complications from doing this could lead to aspiration pneumonia. During an interview on 12/18/25 at 11:42 a.m., via e-mail medical doctor (MD)-A identified that feeding a patient through the wrong tube (G-tube versus the J-tube) could result in increased symptoms of nausea, vomiting and/or worsen reflux. It could also increase the risk of aspiration, reflux and a lung infection (pneumonia). Facility Policy, “Gastrostomy Tube -Gastrostomy/Jejunostomy Tube Feeding,” reviewed 7/16/25, identified a purpose to provide nourishment to clients who are unable to obtain needed nutrition by oral intake. The policy identified the agency will practice accepted procedure for gastrostomy tube feeding and will use only trained and competent staff to perform the procedure. 1.Gastrostomy/Jejunostomy feedings will be done routinely by licensed nursing personnel per physician’s order.”

“Within 48 hours of the patient’s return CFR(s): 484.55(d)(2) Within 48 hours of the patient’s return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This Element is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to update the comprehensive assessment within 48-hours of the patient’s return to home from a hospital admission of 24 hours or more for 1 of 3 patients (P1) reviewed. P1 was admitted to the hospital for three days and the HHA did not provider a skilled nursing visit until 4 days following her discharge and the comprehensive assessment was not updated. Findings include: P1’s Home Health Certification and Plan of Care for period 4/19/25 – 6/17/25 indicated P1’s diagnosis’s were Bipolar II disorder, depression, chronic pain syndrome, Type II diabetes and seizure disorder. P1’s mental status was oriented. P1 was seen by a skilled nurse weekly for medication set-up and vital sign checks. No transfer assessment or return of care was completed by the HHA for her hospital admission and discharge of 5/22/25 – 5/24/25. A hospital summary provided by the HHA dated 5/22/25 indicated P1 was an inpatient in the hospital. The note indicated P1 was a 51-year-old with a history of seizure disorder, anxiety, depression, asthma, bipolar disorder, type 2 diabetes who was admitted on 5/22/25 following several seizures earlier in the day. P1’s principal problem was she presented to the emergency room with several seizure episodes at home, in the setting of missed anti-epileptic (seizure) medication doses. A nursing visit note dated 5/28/25 at 12:28 p.m. indicated P1 had no medications changes since the prior visit, she was compliant between visits. P1 remained compliant with medication, denied falls, in good spirts. She denied seizure activity. P1’s medications were set-up for three weeks. P1 was going on vacation. The note did not indicate P1 was in the hospital from 5/22/25 – 5/24/25 with seizures due to missed medications. Upon interview on 6/16/25 at 12:37 p.m. a hospital social worker (SW)-A stated she met with P1 for hospitalization discharge arrangement due to concerns because the hospitalization was due to missed medications. She stated she notified the HHA and was “alarmed” because P1 was going to be discharged from the hospital on 5/24/25 and the HHA would not be providing a visit until 5/28/25. She stated the plan was for the HHA’s nurse to facetime with P1’s family and have them set-up P1’s set-up P1’s medications until care could be resumed. Upon interview on 6/17/25 at 9:30 a.m. P1 stated she was in the hospital from 5/22/25 -5/24/25 due to seizures following missing her medications. She stated registered nurse, (RN)-A completed a skilled nursing visit on 5/28/25. FM-A set-up medications for a few days, “only the important ones pain and seizure meds.” She was not certain how FM-A communicated with the HHA to set-up her medications via facetime or via text messages. Upon interview on 6/16/25 at 1:54 p.m. RN-A stated she was not aware that P1 had an “actual” hospital admission. She was aware that P1 was in the emergency department (ED) because P1 was scheduled for a skilled nursing the day she presented to the ED. RN-A was contact with FM-A often however does not recall whether she talked her through the medication set-up or not. Upon interview on 6/17/25 at 12:42 p.m. the assistant director of nursing (ADON) stated she was not aware that P1 was admitted to the hospital. She verified she received the emailed hospital summary and stated she must have missed where it was indicated she was admitted because the agency should have completed a visit and performed a comprehensive assessment within 48-hours of her returning home. Upon interview on 6/17/25 at 12:55 p.m. the director or nurse (DON) stated the HHA must complete a transfer assessment and a return of care assessment within 48-hours following a hospital discharge. An HHA policy titled Oasis Implementation and Transmission dated 7/19/24 indicated: Assessments will follow the times identified in the Conditions of Participation: a. The follow-up comprehensive assessment is updated and revised (including the administration of the OASIS) within the last 5 days of the 60 days certification (between and including days 56-60 of certification period) b. Updated comprehensive assessment is completed within 48 hours of (or knowledge of) the patient’s return home from a hospital stay of 24 hours or more for any reason except diagnostic tests or from an inpatient stay (resumption of care OASIS data set) c. Updated comprehensive assessment is completed within 48 hours of (or knowledge of) transfer to any inpatient facility (transfer to an inpatient facility comprehensive assessment with OASIS data items integrated, with or without agency discharge) d. Updated comprehensive assessment is completed within 48 hours of (or knowledge of) discharge to the community or death at home (discharge OASIS assessment with OASIS data items integrated).”

“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 observation interview and record review the home health agency (HHA) failed to ensure the individualized care plan included all the supplies and/or equipment in the homes of 2 of 3 patients (P1 and P2). Findings include: P1’s Home Health Certification and Plan of Care for period 4/19/25 – 6/17/25 indicated P1’s diagnosis’s were Bipolar II disorder, depression, chronic pain syndrome, Type II diabetes and seizure disorder. P1’s mental status was oriented. P1 was seen by a skilled nurse weekly for medication set-up and vital sign checks. P1’s durable medical equipment (DME) and supplies indicated P1 had a cane, scooter, and crutches. P1’s care plan did not indicate she had a bed rail. Upon observation and interview on 6/17/25 at 9:30 a.m. one half-length bed rail was observed in P1’s room. P1 stated she had two half-length bed rails for her bed, but one of them broke, that was why she only had one on her bed. P1 used the bed rail for sitting to standing transferring due to spinal fusions in her back, post knee surgeries, and post surgeries to her left hand. P1 stated her home care nurse, registered nurse (RN)-A had seen the rail in her room. She denied receiving any education on the safety of bed rails. P1 had a nebulizer machine and a chest physiotherapy vest (CPT) in her bedroom. She used both devices daily and the devices were ordered by her pulmonary and sleep provider. In addition, her medications were set-up in a MD2 dispenser (monitored automatic pill dispenser), and she had a toilet raiser over the toilet in her bathroom. P2 P2’s Home Health Certification and Plan of Care for period 4/22/25 – 6/20/25 indicated R2’s pertinent diagnosis’s were heart failure unspecific, hypertensive chronic kidney disease, chronic obstructive pulmonary disease (a progressive lung disease that causes airflow obstruction and breathing difficulties. P2’s DME and supplies indicated P1 used a bed side commode, cane, oxygen, and a walker. P2’s care plan did not indicate P2 had a bed rail on her bed. Upon interview on 6/16/25 at 1:54 p.m. registered nurse (RN)-A stated she identified P1’s home as cluttered and was aware that P1 had a nebulizer, an MD2 machine and a bed rail. She was not aware of P1’s toilet raiser or her CPT vest. RN-A stated she was aware that P2 had the bed rails and the MD2 machine. RN-A did not provide a reason for the DME missed on P1’s assessment or P2’s assessment. Upon interview on 6/17/25 at 12:42 p.m. the assistant director of nursing (ADON) stated all DME/supplies should be on the assessment. She was the case manager for P1 and P2 however was not aware what supplies they had in their homes because RN-A was a registered nurse, and she reported on P1 and P2 so the ADON could fill out the assessment tool every 60 days. Upon interview on 6/17/25 at 12:55 p.m. the director of nurse (DON) stated the HHA recently completed bed rail education with the staff. He stated the facility was to indicate the use of the bed rails on the care plan and the HHA had put together education on the risk and benefits that was to be taught to all patients with bed rails. He verified the patient’s do not need rehabilitation services in the home for the nurses to assess and education on the use of bed rails and the HHA must identify all DME and supplies on the patient’s assessment. Upon interview on 6/17/25 at 1:28 p.m. RN-A stated she had seen bed rails at both P1 and P2’s homes. She stated the HHA does not have an order for the rails because the patients were not on Medicare, nor did they have physical or occupation therapy services in the home. Upon interview on 6/17/25 at 3:37 p.m. P2 stated she had a half-length bed rail that slid between her mattresses. She used the bed rail for transferring in and out of bed. She denied receiving any education from the HHA regarding the use of the bed rail. In addition, she had a MD2 machine. An HHA policy titled Coordination of Services dated 7/19/25 indicated: The essential components of professional coordination of home care services include the following: Assessing and planning for the required services, supplies, and equipment as ordered or approved by the physician. An agency policy titled Practice Policies Restraints dated 11/15/24 indicated: Policy Clients receiving homecare services and living in their own home have the right to be free of restraints and must have all other measures taken to avoid them. This includes any physical, chemical, or environmental form that restricts the client’s movement. If a form of restraint is needed, the client and/or guardian are agreeable, and all other options have been exhausted they must be ordered by the doctor and may only be used to ensure the immediate physical safety of the patient, staff or others and must be discontinued at the earliest possible time. In the event there are safety concerns, family members will be asked to assist to keep the client safe. Definitions: 1. Physical restraints are defined as: Any manual method or physical or mechanical device, material or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body. Restraints are considered a form of medical treatment. 2. Side Rails are not a restraint a. When used to prevent the patient from sliding out of bed with beds with certain therapeutic surfaces, and other beds that have slippery surfaces b. When used with patients who are experiencing involuntary movements c. When used with patients who are not physically capable of getting out of bed regardless of whether side rails are raised or not d. When padded and raised for Seizure Precautions Procedure 1. If an employee is concerned over the safety and the well-being of a client, they should first discuss with the supervising nurse who will involve family as necessary and assist with the implementation of alternative measures that may be provided for the client safety. Physicians and case managers will be included and updated as necessary. 2. Other methods will be used in the effort to keep the client safe. These may include but are not limited to more frequent monitoring, using a companion, sitter, distraction, redirection, etc. 3. Prior to any form of restraint, the family will be asked to assist staff in keeping the client safe. 4. If the concerns are not relieved by alternative methods a care conference will be held to determine the next plan or option. 5. The client physician will be involved throughout the process to monitor the condition changes to address any medical or behavioral concerns. 6. All equipment and/or supplies deemed necessary for the client’s safety must be ordered by the physician. 7. In the event of a form of restraint being necessary it must follow the following guidelines. a. All other methods for client safety have been tried and documented. b. The client and/or guardian are made aware of the situation and agrees. If either party disagrees, no form of restraint may be allowed. c. A doctor must medically order any type of restrictive equipment along with the proper use. d. Staff must be present to always monitor and document the occurrence. e. The restraint must be removed as soon as it is safely able to.”

“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 interview and record review the home health agency (HHA) failed to conform with practitioner orders for 1 of 3 patients (P1). P1 was ordered to have weekly skilled nursing visits weekly for medication set-up. P1 was going on a vacation for three weeks. Registered nurse, (RN)-A filled three weeks of medications for P1 without getting an order from the provider for a safe travel plan. P1 had missed doses of medications over the three-week period and ended up having seizures with a three-day hospital stay. Findings include: P1’s Home Health Certification and Plan of Care for period 4/19/25 – 6/17/25 indicated P1’s diagnosis’s were Bipolar II disorder, depression, chronic pain syndrome, Type II diabetes and seizure disorder. P1’s mental status was oriented. P1 was seen by a skilled nurse weekly for medication set-up and vital checks. A hospital summary dated 5/22/25 indicated P1 was an inpatient in the hospital. The note indicated P1 was a 51-year-old with a history of seizure disorder, anxiety, depression, asthma, bipolar disorder, type 2 diabetes who was admitted on 5/22/25 following several seizures earlier in the day. P1’s principal problem was she presented to the emergency room with several seizure episodes at home, in the setting of missed anti-epileptic medication doses. A nursing visit note dated 4/22/25 indicated P1 remained complaint with medication, denied falls and in good spirts. She denied seizure activity. P1’s medication was set-up for 3 weeks. P1 was going on vacation. A missed visit note dated 5/2/25 at 7:00 p.m. indicated P1 had a skilled nursing visit on 5/2/25. P1 was out of town on a cruise. The note did not indicate P1 had three weeks of medication set-up or how her needs were going to be met. A missed visit note dated 5/16/25 at 7:00 p.m. indicated P1 had a skilled nursing visit on 5/2/25. P1 was out of town on a cruise. The note did not indicate P1 had three weeks of medication set-up or how her needs were going to be met. A missed visit note dated 5/23/25 at 6:00 p.m. indicated P1 had a skilled nursing visit on 5/23/25, however was at the emergency room. No other details documented. A nursing visit note dated 5/28/25 at 12:28 p.m. indicated P1 had no medications changes since the prior visit, she was compliant between visits. P1 remained compliant with medication, denied falls, in good spirts. She denied seizure activity. P1’s medications were set-up for three weeks. P1 was going on vacation. The note did not indicate P1 was in the hospital from 5/22/25 – 5/24/25 with seizures due to missed medications. Upon interview on 6/16/25 at 12:55 p.m. a hospital social worker (SW)-A stated she met with P1 in the hospital due to medication noncompliant. SW-A was told that P1 was supposed to be seen weekly by a nurse and had her medications set-up in her MD2 machine (a machine that dispensed and notifies the patient when to take the medication). P1 told SW-A she went on vacation and was very confused about her medications. On one instance she missed four entire days of medications which included her anti-epileptic medications, and, on another instance, she was confused with how her medications were set-up. P1 was not able to identify her medications and did not have a list to follow while on vacation. Upon observation and interview on 6/17/25 at 9:30 a.m. P1 demonstrated the use of her MD2 machine and showed bin overflowing with medication bottles, stating she could not keep her medication straight without assistance. P1 provider’s order were to have weekly skilled nursing visits for medication set-up. She was not certain if her provider was notified and gave new orders for her vacation. P1 went on her vacation with three weeks of her medications set-up in plastic pill boxes. She forgot to take the medications on a 4-day cruise, missing 4 full days of medications. She completed the cruise and continued her vacation for two days and was confused about her medications and missed a “few doses.” The day after she returned home, she had 5-6 seizures and was taken to the emergency department. She admitted to the hospital from 5/22/25 - 5/24/25. Upon interview on 6/16/25 at 1:54 p.m. registered nurse, (RN)-A stated she set-up P1’s medication for 3 weeks prior to a vacation. She denied notifying the provider to obtain orders prior to the visit. Her process was to fill-out and send a missed visit note to the provider on the day the actual visits were missed. She stated she believed P1, per her assessment, was able to take her medications correctly as long as they were set-up. It was not the HHA’s policy to obtain vacation medication set-up orders or ask for safe guidance when a patient is away from home. Upon interview on 6/17/25 at 12:42 p.m. the assistant director of nursing (ADON) stated the HHA sets up medications for as long as the patients want for their vacations and notify the provider at the time a visit was missed. She stated each patient was assessed on an individual basis. The HHA could have a different plan for each patient on their individual need for vacation. Notifying the provider to change the frequency order and any additional safety guidelines was not needed for the HHA as the patients had a right to dictate their time away. Upon interview on 6/17/25 at 12:55 p.m. the director or nurse (DON) stated the HHA must notify the provider before changing any orders. An HHA policy titled Service Policies, Coordination of services dated 7/11/24 indicated: Communication between the staffer, support staff, nurse, and doctor to notify of any missed or deferred services.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to provide communication with all the physician involved in the plan of care related to the current plan of care for 2 of 3 patients (P1 and P2) reviewed. P1 and P2 and providers other than their primary physicians ordering medications and/or treatments for them. Findings include: P1’s Home Health Certification and Plan of Care for period 4/19/25 – 6/17/25 indicated P1’s diagnosis’s were Bipolar II disorder, depression, chronic pain syndrome, Type II diabetes and seizure disorder. P1’s mental status was oriented. P1 was seen by a skilled nurse weekly for medication set-up and vital checks. No transfer assessment or return of care was completed by the HHA. Upon interview on 6/17/25 at 9:30 a.m. P1 stated she has multiple providers. She received medication and/or treatment orders from a gastroenterologist, the Epilepsy Foundation, the pain clinic, and she had a sleep and lung specialist. P1’s Patient Profile dated 6/17/25 indicated information only for a primary care provider. P2’s Home Health Certification and Plan of Care for period 4/22/25 – 6/20/25 indicated R2’s pertinent diagnosis’s were heart failure unspecific, hypertensive chronic kidney disease, chronic obstructive pulmonary disease (a progressive lung disease that causes airflow obstruction and breathing difficulties). P2 was seen by a skilled nurse weekly for medication set-up and skilled observation of vital signs and respiratory status. Upon interview on 6/17/25 at 3:37 p.m. P2 stated she had a primary care provider and received care from a cardiologist and a nephrologist. P2’s Patient Profile dated 6/18/25 indicated information only for a primary care provider. Upon interview on 6/16/25 at 1:54 p.m. registered nurse (RN)-A stated she was aware that P1 had multiple specialists involved in her care, and she had reached out to many of them. She was not certain whether the HHA kept track of the specialists or not. Upon interview on 6/17/25 at 12:42 p.m. the assistant director of nursing (ADON) stated that the HHA notifies the primary care physicians only and they coordinate the care with the specialists. The primary care provider is aware of all the medications the patients take because they are listed on the 60-day assessments. Upon interview on 6/17/25 at 12:55 p.m. the director or nurse (DON) stated the HHA must identify all the providers in the patient’s care on the patient’s profile. An HHA policy titled Coordination of Services dated 7/19/24 indicated the agency worked with contracted service agencies to ensure good communication and coordination of services.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on observation, interview, and record review the home health agency (HHA) failed to provide services in accordance with clinical practice guidelines and accepted professional standards of practice when 2 of 3 patients (P1 and P2) reviewed used of bed rails in their homes. Findings include: A Food and Drug Administration (FDA)website regarding bedrail safety viewed 6/17/25 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362848.htm indicated: Education /Training Hospitals, long term care facilities, and home health care providers should provide education and training about bed rail use to assist in creating and implementing a safe and comfortable sleeping environment for their patients. It is recommended that the education and training be directed toward the following groups: • Staff • Patient/family • Physicians, including medical directors and physician extenders such as physician assistants and nurse practitioners • Long term care ombudsman • Regulatory agencies or representatives Bed Rail Safety Guidelines If it is determined that bed rails are required and that other environmental or treatment considerations may not meet the individual patient’s assessed needs or have been tried and were unsuccessful in meeting the patient’s assessed needs, then close attention must be given to the design of the rails and the relationship between rails and other parts of the bed. 1. The bars within the bed rails should be closely spaced to prevent a patient’s head from passing through the openings and becoming entrapped. 2. The mattress to bed rail interface should prevent an individual from falling between the mattress and bed rails and smothering. 3. Care should be taken that the mattress does not shrink over time or after cleaning. Such shrinkage increases the potential space between the rails and the mattress. 4. Check for compression of the mattress’ outside perimeter. Easily compressed perimeters can increase the gaps between the mattress and the bed rail. 5. Ensure that the mattress is appropriately sized for the selected bed frame, as not all beds and mattresses are interchangeable. 6. The space between the bed rails, the mattress, the headboard, and the mattress should be filled either by an added firm inlay or a mattress that creates an interface with the bed rail that prevents an individual from falling between the mattress and bed rails. 7. Latches securing bed rails should be stable so that the bed rails will not fall when shaken. 8. Older bed rail designs that have tapered or winged ends are not appropriate for use with patients assessed to be at risk for entrapment. 9. Maintenance and monitoring of the bed, mattress, and accessories. P1’s Home Health Certification and Plan of Care for period 4/19/25 – 6/17/25 indicated P1’s diagnosis’s were Bipolar II disorder, depression, chronic pain syndrome, Type II diabetes and seizure disorder. P1’s mental status was oriented. P1 was seen by a skilled nurse weekly for medication set-up and vital checks. P1’s care plan did not indicate she had a bed rail. No safety guidelines were included such as measurements, placement, latches, set-up, mattresses used and maintenance of the side rails. Upon observation and interview on 6/17/25 at 9:30 a.m. one half-length bed rail was observed in P1’s room. P1 stated she used to have two half-length side rails for her bed, but one of them broke. She reported getting a new bed and was waiting for a family member to left and slide the rail between her mattresses. P1 used the bed rail for sitting to standing transferring due to spinal fusions in her bed, post knee surgeries and post surgeries to her left hand. P1 stated her home care nurse, registered nurse (RN)-A had seen the bed rail in her room. She stated she believed RN-A had seen the bed rail. She was not aware if RN-A completed an assessment of the bed rail. P2’s Home Health Certification and Plan of Care for period 4/22/25 – 6/20/25 indicated R2’s pertinent diagnosis’s were heart failure unspecific, hypertensive chronic kidney disease, chronic obstructive pulmonary disease. P2’s care plan did not indicate P2 had a bed rail on her bed. No safety guidelines were included such as measurements, placement, latches, set-up, mattresses used and maintenance of the bed rails. Upon interview on 3/17/25 at 3:37 p.m. P2 stated she had a half-length bed rail that slid between her mattresses. She used it for transferring in and out of bed. She denied any nursing assessment of the bed rails. Upon interview on 6/17/25 at 1:28 p.m. RN-A stated she had seen bed rails at both P1 and P2’s homes. She stated the HHA does not have an order for the rails because the patients were not on Medicare, nor did they have physical or occupation therapy services in the home. She would not be involved with bedrails due to the payor source for P1 and P2 since the payor was not Medicare. Upon interview on 6/17/25 at 12:55 p.m. the director of nurse (DON) stated the HHA recently completed bed rail education with the staff. He stated the facility was to indicate the use of the bed rails on the care plan and the HHA had put together education on the risk and benefits that was to be taught to all patients with bed rails. He verified the patient is do not need rehabilitation services in the home meaning skilled nurses need to ensure the safety guidelines were met. An agency policy titled Practice Policies Restraints dated 11/15/24 indicated: Policy Clients receiving homecare services and living in their own home have the right to be free of restraints and must have all other measures taken to avoid them. This includes any physical, chemical, or environmental form that restricts the client’s movement. If a form of restraint is needed, the client and/or guardian are agreeable, and all other options have been exhausted they must be ordered by the doctor and may only be used to ensure the immediate physical safety of the patient, staff or others and must be discontinued at the earliest possible time. In the event there are safety concerns, family members will be asked to assist to keep the client safe. Definitions 1. Physical restraints are defined as: Any manual method or physical or mechanical device, material or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body. Restraints are considered a form of medical treatment. 2. Side Rails are not a restraint a. When used to prevent the patient from sliding out of bed with beds with certain therapeutic surfaces, and other beds that have slippery surfaces b. When used with patients who are experiencing involuntary movements c. When used with patients who are not physically capable of getting out of bed regardless of whether side rails are raised or not d. When padded and raised for Seizure Precautions Procedure 1. If an employee is concerned over the safety and the well-being of a client, they should first discuss with the supervising nurse who will involve family as necessary and assist with the implementation of alternative measures that may be provided for the client safety. Physicians and case managers will be included and updated, as necessary. 2. Other methods will be used in the effort to keep the client safe. These may include but are not limited to more frequent monitoring, using a companion, sitter, distraction, redirection, etc. 3. Prior to any form of restraint, the family will be asked to assist staff in keeping the client safe. 4. If the concerns are not relieved by alternative methods a care conference will be held to determine the next plan or option. 5. The client physician will be involved throughout the process to monitor the condition changes to address any medical or behavioral concerns. 6. All equipment and/or supplies deemed necessary for the client’s safety must be ordered by the physician. 7. In the event of a form of restraint being necessary it must follow the following guidelines. a. All other methods for client safety have been tried and documented. b. The client and/or guardian are made aware of the situation and agrees. If either party disagrees, no form of restraint may be allowed. c. A doctor must medically order any type of restrictive equipment along with the proper use. d. Staff must be present to always monitor and document the occurrence. e. The restraint must be removed as soon as it is safely able to.”

“Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient’s status at the time of assessment. This Standard is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to accurately assess 1 of 3 patient’s (P1). P1 had a known cardiac diagnose that was not coded on the Oasis certification. Findings include: P1’s clinical physical note dated 6/2/23 indicated P1 had a complicated history and indicated he had a diagnosis of pulmonary valve stenosis (a heart defect that occurs when the pulmonary valve narrows, restricting blood flow from the heart’s right ventricle to the lungs). P1’s Oasis recertification dated 2/27/25 – 4/27/25 indicated P1’s active diagnoses were diagnoses were myotonic muscular dystrophy (a hereditary muscular disease featuring and inability to relax muscles at will, where muscles are weakened and damaged), tracheostomy status (a surgical opening in the windpipe to allow breathing), respiratory failure, dependent on respirator (requiring mechanical ventilation to breathe effectively), neuromuscular scoliosis, thoracolumbar region (a sideways curvature of the spine in that impairs the ability to control the muscles), gastrostomy status (opening in the stomach for a feeding tube). No cardiac diagnoses were identified. Under the heading Cardiac Status, no problems were identified. In addition, under the heading patient’s history associated with circulatory system was listed as nonapplicable. P1’s Home Health Certificate and Plan of care for certification period 2/27/25 – 4/27/25 indicated P1 diagnoses were myotonic muscular dystrophy, tracheostomy status, respiratory failure, dependent on respirator, neuromuscular scoliosis, thoracolumbar region, gastrostomy status. P1 was oriented with a mild intellectual disability. P1’s treatment and orders for disciplines were respiratory therapy (RT) 7-14 visits a week, skilled nursing 24 hours per day. Upon interview on 4/11/25 at 12:45 p.m. respiratory therapist (RT)-A stated during an interview regarding P1’s respiratory suctioning that P1 had a cardiac issue that would change the orders in the event of an emergency. She stated if P1 was having an emergency with his tracheostomy she would not recommend changing the tracheostomy tubing due to P1’s pulmonary valve stenosis because of the stenosis, his airway could clamp down and the vascular bed causing closure of the airway. RT-A stated upon her initial visit with P1 she asked the agency case manager and Administrator if P1 had any cardiac defects and was then told he had pulmonary valve stenosis. RT-A was not aware the diagnosis was not on the nurses assessment and plan of care. Upon interview on 4/11/25 at 3:32 the direct of nursing, (DON) stated he believed that P1’s pulmonary valve stenosis was not on his assessment was because the agency was not completing cares under that diagnosis. Upon interview on 4/11/25 at 3:40 p.m. the Administrator stated the reason the pulmonary valve stenosis diagnosis was not on the assessment was because he was not on any medications for it and the agency was not providing cares for that diagnosis. She was aware of the diagnosis. An agency policy titled OASIS implementation and transmission reviewed on 7/19/24 did not indicate anything about the accuracy of the assessment.”

“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 record review the home health agency (HHA) failed to conform with practitioner orders for 1 of 3 patients (P2). P2 was ordered to have a mechanical soft diet with small bites and small frequent meals. P2’s nurses were not aware of his dietary orders therefore were not following his dietary orders. Findings include: P2’s Home Health Certification and Plan of Care for certification period 2/27/25 – 4/27/25 indicated P2’s pertinent diagnoses were myotonic muscular dystrophy (a hereditary muscular disease featuring and inability to relax muscles at will, where muscles are weakened and damaged), mild intellectual disabilities and dysphagia (difficulty swallowing foods or liquids). P2’s diet was mechanical soft (preparing foods to a soft texture). P2 was to have small bites, and small frequent meals. P2 required aspiration precautions (measure to prevent food, liquid, or saliva to enter the lungs) and proper positioning during meals. P2’s plan of care did not identify that P2 was noncompliant with his ordered diet. P2’s treatment and orders for discipline were respiratory therapy 7-14 visits per week. Nursing assistant 16 hours per day and skilled nursing 24 hours per day. P2’s nursing notes dated 3/29/25 – 4/11/25 did not indicate what client was fed nor did they indicate he was noncompliant with meals. P2’s nursing note dated 4/8/25 indicated P2’s diet orders were given regular diet. P2’s nursing note dated 4/9/25 indicated P2’s diet orders were given regular diet. P2’s nursing note dated 4/10/25 indicated P2’s diet orders were given regular diet. P2’s nursing note dated 4/11/25 indicated P2’s diet orders were given regular diet. Upon interview on 4/9/25 at 10:51 p.m. P2 stated he had not eaten yet that day. He stated he was supposed to be a on a soft diet but does not recall choking since he had been at the “new house.” P2 stated if he cannot hold the food himself and chew on it the staff will cut it for him. The foods P2 ate where he would hold it while taking bites were hamburgers, tacos, and pizza. He stated he liked it and had been given Cheetos and other types of chips. Upon observation and interview on 4/9/25 at 11:08 a.m. licensed practical nurse, (LPN)-B asked P2 if he would like chicken nuggets and French fries for lunch. He agreed. LPN-B stated she thought P2 was on a regular diet. LPN-B did not know where to find P2’s diet order in the software system. LPN-B made him the chicken nuggets and cut them for him without incident. Upon interview on 4/10/25 at 12:08 p.m. registered nurse, (RN)-D stated P2 was a choking hazard, and he was a fussy eater, however she believed he was on a regular diet. She stated she always watched him closely while eating as P2 would pick-up finger food himself like pizza and take bites from it. Upon interview on 4/11/25 at 9:18 a.m. P2’s Physician Assistant, (PA) stated he was a choking hazard, and his diet was to be mechanical soft with small portions and food cut-up. She stated the agency had not notified her of any dietary concerns or requested a different diet. Upon interview on 4/11/25 at 3:20 p.m. RN-E, P2’s agency case manager stated P2 eats what he wants. He was supposed to have small bites and frequent feeding along with following a soft diet, but he will not eat it. She stated at times it took him and hour or two to complete a meal. She did not believe she asked the provider to change his dietary order or assist with a solution. An agency policy titled General Administration with a review date of 7/19/4 indicated: All clients are visited as defined in the physician orders and/or client plan of care. Nurse Managers are responsible for coordination of all services and communication with the physician and other agencies. All activities are performed according to acceptable professional standards and policies. Nurse Managers are responsible for coordination of all the services and for seeing that the established plan of care is carried out.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on interviews and record review the home health agency (HHA) failed to conduct a thorough respiratory assessment for 1 of 3 patients (P1) reviewed. P1 was suctioned five times over approximately six hours and P1 continued to complain of the need for suctioning. P1 was sent to the hospital. Findings include: National Library of Medicine, Nursing Skills, Chapter 10 Respiratory Assessment retrieved on 4/11/25 from https://www.ncbi.nlm.nih.gov/books/NBK593192/#:~:text=Obtain%20the%20respiratory%20rate%20over,and%20in%20a%20regular%20rhythm indicated a focused respiratory objective assessment includes interpretation of vital signs; inspection of the patient’s breathing pattern, skin color, and respiratory status; palpation to identify abnormalities; and auscultation of lung sounds using a stethoscope. For more information regarding interpreting vital signs, see the “General Survey” chapter. The nurse must have an understanding of what is expected for the patient’s age, gender, development, race, culture, environmental factors, and current health condition to determine the meaning of the data that is being collected. Inspection during a focused respiratory assessment includes observation of level of consciousness, breathing rate, pattern and effort, skin color, chest configuration, and symmetry of expansion. Objective Assessment Prior to suctioning, a baseline assessment for indications of respiratory distress and the need for suctioning should be obtained and documented, including, but not limited to, the following: Secretions from the mouth and/or tracheal stomaAuscultation of lung soundsHeart rateRespiratory rateCardiac rhythmOxygen saturationSkin color and perfusionEffectiveness of cough [1] P1’s Home Health Certificate and Plan of care for certification period 2/27/25 – 4/27/25 indicated P1 diagnoses were myotonic muscular dystrophy (a hereditary muscular disease featuring and inability to relax muscles at will, where muscles are weakened and damaged), tracheostomy status (a surgical opening in the windpipe to allow breathing), respiratory failure, dependent on respirator (requiring mechanical ventilation to breathe effectively), neuromuscular scoliosis, thoracolumbar region (a sideways curvature of the spine in that impairs the ability to control the muscles), gastrostomy status (opening in the stomach for a feeding tube). P1 was oriented with a mild intellectual disability. P1’s safety measures included: Aspiration precautions (measure to prevent food, liquid, or saliva to enter the lungs) Assistance with activities of daily living Equipment safety Fall/safety precautions. Respiratory/Tracheostomy precautions Oxygen precautions. Safe transfers Supervision Transfer precautions Universal precaution Use of Assistance Devices P1’s treatment and orders for disciplines were respiratory therapy (RT) 7-14 visits a week, skilled nursing 24 hours per day. P1’s nursing visit note dated 3/30/25 from 8:06 a.m. – 4:00 p.m. indicated at 2:00 p.m. P1’s temperature was 97.1 degrees Fahrenheit (F) (normal 97.5 – 98.9 F), his pulse rate was 72 (normal range 60-100), pain level was a 0 (0-10 indicating no pain 0 and 10 extreme), P1’s skin was clear, pink, and warm. His mucous membranes (moist lining of nose, mouth, lungs, and stomach) were warm. He was alert, responsive and awake, his motor functions were of purposeful movement with limited range of motions. P1 was chairbound with no seizure activity. His respirations were regular, his oxygen and trach collar clear. He was not on an oxygen nasal cannula or mask. Tracheostomy was cuffed and the site was cleaned with an aseptic technique. P1’s heart tones were regular; he had no edema (fluid retention), and his capillary refill (applying pressure to the fingertip to see how fast blood returns) was brisk < 3 seconds (normal 1-3 seconds) P1’s abdomen was soft with active bowel sounds in all four quadrants. P1’s assessment on the nursing note did not indicate P1’s blood pressure, oxygen saturation (O2 sat), suction or suction size, or what safety precautions were completed. P1’s 2:00 p.m. assessment was the only documented assessment on 3/30/25 and there were no other notes on the suctioning P1 received. P1’s narrative nursing note/comments indicated: licensed practical nurse (LPN)-A arrived at the agencies home at 8:05 on 3/30/25 and P1 was in bed sleeping. At 9:30 a.m. LPN-A set up P1’s feeding which went on for 2 hours. At 10:20 a.m. LPN-A suctioned P1’s mouth and tracheostomy site. At 11:30 a.m. P1 was given a bed bath and dressed. LPN-A deflated P1’s cuff (a little balloon at the end of the tube which seals off the airway) and put the speaking valve (a one-way valve that allows a patient on a tracheostomy speak) on. At 11:45 a.m. P1 had another suction of his mouth and tracheostomy site. At 12:30 p.m. P1 stated he was needing more suctioning, which was just completed without much secretion. LPN-A went to find registered nurse (RN)-A who was working in the upstairs of the home and explained she suctioned P1 without much secretion and P1 was still complaining of secretions. At an unidentified “later” time LPN-A gave P1 his second feeding which lasted about an hour. At 1:30 p.m. LPN-A completed another mouth and tracheostomy suctioning. At 1:45 p.m. LPN-A asked P1 if he wanted to go be with his brother, which P1 declined and wanted to stay in his room and watch television on his phone. At 1:50 p.m. LPN-A again completed suction on the tracheostomy with not much secretion. At 2:15 p.m. RN-D notified LPN-A that P1 was unresponsive. RN-D called for help and ran upstairs to call the other nurse. LPN-A and RN-A placed P1 on the floor. RN-A started chest compression while LPN-A called 911 at 2:16 p.m. The paramedics arrived at 2:20 p.m. The emergency respondent was on the phone with LPN-A giving instructions on how to perform cardio-pulmonary resuscitation (CPR) while the staff waited for the paramedics to arrive. The paramedics took over CPR upon arrival. Upon interview on 4/9/25 at 10:49 a.m. RN-C stated he did not work the day P1 was sent to the hospital. P1 stated he had worked with patients with respiratory concerns for 17 years and stated his expectation and practice is at the minimum complete a respiratory assessment, closely monitor the patient, and continuously monitor his O2 sats. Upon interview on 4/9/25 at 12:08 p.m. RN-D stated she was working upstairs the day P1 was sent to the hospital. She stated she went downstairs of the home around 2:15 p.m. and looked in P1’s room and found he was unresponsive in his wheelchair. P1’s color was pale. RN-D shook P1 without a response and shouted for assistance. RN-D assisted with CPR. She stated she aware P1 had a change of condition that same morning as LPN-A asked for assistance from the nurses who were working upstairs. She was not aware of what assessments LPN-A had completed during the multiple times she suctioned him. Upon interview on 4/10/25 at 4:38 p.m. the hospital pulmonary provider stated P1 arrived at the hospital in pulmonary arrest (patient had stopped breathing) and brain anoxia (loss of oxygen to the brain). The provider was unable to determine if the brain anoxia suffered by P1 was the result of the uncertainly of the timing P1 was unresponsive for. He stated P1 was a complex case and anoxic brain injury can happen to some patient’s within minutes and others can go for up to an hour or more without suffering a brain injury. The provider stated his expectation of nursing staff would be to provider thorough nursing assessments such as a respiratory assessment. He stated he would expect to see vital signs, lung sounds and O2 saturations often. If the patient was still struggling with secretions the nurse should call respiratory therapy or the nursing supervisor for direction. Upon interview on 4/15/25 at 7:00 p.m. LPN-A stated she suctioned P1 at 10:20 a.m. and again 11:45 a.m. with “minimal” results. At 12:30 p.m. P1 was complaining he needed more suctioning LPN-A felt P1 needed a deeper suctioning and had never performed deep suctioning on patient, so she asked RN-A for assistance. RN-A suctioned P1 with the same “minimal” results. At 1:30 p.m. P1 was still complaining of needing to be suctioning LPN-A suctioned him again and P1 still felt he needed more. LPN-A asked P1 if it was o.k. to wait for respiratory therapy to come for their second visit of the day. P1 agreed. LPN-A was uncertain of the time the therapist would arrive. LPN-A stated she was completing her daily charting when RN-D found P1 unresponsive. P1 released a lot of mucous with the chest compressions during CPR. LPN-A stated 2:00 p.m. assessment she charted on P1 was not in real time, she stated that charting was from her approximately 10:00 a.m. assessment. She did not complete any further assessments when P1 continued to require suctioning. LPN-A stated P1 did not appear sick therefor she did not feel any further assessing was required. Upon interview on 4/11/25 at 9:18 a.m. P1’s Physician Assistant (PA) stated it sounded like P1 needed deep suctioning and she had never ordered deep suctioning. She stated a deep suctioning order would come from respiratory therapy. She was not aware if the nursing staff were trained in deep suctioning. If staff was unable to deep suction they should have called respiratory therapy. Her expectation of a patient complaining of sections following multiple attempts at suctioning would be to take vital signs along with O2 sats more frequently and to frequently monitor the patient. She was uncertain what type of assessment should have been completed, however staff should follow the agencies assessment protocol. She stated the nurse should have notified respiratory therapy, called the agency nursing supervisor, and left a message on the providers online portal (the providers website that was monitored 24-hours a day for updates and questions). Upon interview on 4/11/25 at 12:45 p.m. respiratory therapist (RT)-A and agency trainer stated all nursing staff were trained on deep suctioning prior to working with the patients. She stated with any change in a patient staff should perform nursing assessments which included a pulmonary assessment and monitor the patient’s closely as tracheostomy patients can change rapidly. Upon interview on 4/11/25 at 3:32 p.m. the director of nursing (DON) stated when a patient has a change of status who is a tracheostomy a respiratory assessment should be completed. In addition, the nurse should be charting every suctioning event along with the assessment completed with the results of the suctioning such as color of sputum, amount, and the type suctioning completed. An agency policy titled Tracheostomy Tube Suction Technique last reviewed 7/19/2024 did not indicate which assessments should be performed with suctioning. The policy did indicate staff should document cares and patient response. An agency policy titled Respiratory care review date of 7/19/24 indicated: Definition. Homecare nursing and Respiratory Therapy Services for respiratory patients focuses on improving survival, decreasing complications, and enhancing quality of life while promoting patient independence and self-management. It involves a range of services, including medication and disease education, oxygen therapy, vital signs monitoring, and coordination with other healthcare professionals. Policy Evaluation: Assess the patient’s respiratory status, including lung function and sounds, oxygen saturation, and the ability to manage secretions. Treatment: Based on the doctor orders, a care plan would be developed outlining specific interventions, such as: 1. Respiratory Therapy Services: This therapy can be provided in conjunction of nursing services or by itself. 2. Respiratory Assessment and Monitoring: Assess lung sounds, oxygen saturation, and other vital signs to detect changes in respiratory status. 3. Oxygen Therapy: Administer oxygen therapy, ensuring proper delivery and monitoring the patient’s response. 4. Breathing Exercises: Teach and guide patients in performing breathing exercises to improve lung function and airway clearance. 5. Medication Administration and Education: Administer medications, educate patients on their proper use, and monitor for side effects. 6. Patient Positioning: Assist patients with positioning to optimize breathing and comfort. 7. Coordination of Care: Collaborate with physicians, therapists, and other healthcare providers to ensure a holistic approach to care. 8. Infection Prevention: Implement infection control measures to protect patients from respiratory infections. 9. Supportive Care: Provide support for the patient’s emotional and psychological well-being, as well as their family. 10. Education: Educate patients and families about respiratory conditions, treatments, and self-management techniques. 11. Pulmonary Rehabilitation: Assist patients with pulmonary rehabilitation programs to improve their exercise capacity and overall quality of life. Procedure 1. At the time of admission, the admitting clinician will assess the client for respiratory diagnosis and needs. 2. Physician orders will be obtained for all services, assessments, treatments, and equipment. 3. The agency will coordinate the orders and need for Respiratory Services if applicable. 4. The client will receive all ordered cares and services which may be (but are not limited to): a. Assessments b. Oxygen Therapy c. Inhalation Therapy d. Airway Clearance e. Ventilator Support f. Pulmonary Rehabilitation g. Patient/Caregiver Education 5. Staff will be properly trained in emergency procedures in the home such as choking, sudden respiratory distress, and ventilator malfunctions. 6. Infection control will be practiced, and the client and family will receive education. This will include hand hygiene, basic infection control, and proper maintenance and cleaning of equipment. 7. All cares will be provided as ordered by the doctor and documented. Any refusals will be addressed and documented.”

“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 2 of 4 residents reviewed. The patients (P2 and P3) did not have a way to notify staff when they required assistance, except by yelling for staff attention. P2 P2’s Home Health Certification and Plan of Care for period 1/31/25 and 3/31/25 indicated P2’s pertinent diagnoses included quadriplegia, C1-C4 complete (no motor function in the arms or legs, only head and neck movement). R2 required 24-hour supervision, fall/safety precautions, respiratory/trach precautions, skin care and universal precautions. P2’s functional limitations were bowel and bladder incontinence, contracture (hardening of muscles), paralysis, endurance, and ambulation. P2’s activities permitted were to be up as tolerated and transfer from bed to the chair. P2’s mental status was orientated. Upon observation and interview on 3/17/25 at 9:38 a.m., P2 was seated in an upright position in his hospital bed. P2 stated when he required staff assistance he would have to shout out and keep shouting until staff arrived. He stated with the location of his room staff came quickly. Having to yell made he feel “undignified” especially if visitors were in the house as they could look right in his room at him. He stated he didn’t have any use of his arms, and he was born without legs. He would like to have a device in which he blows into to call for assistance or a baby monitor where only the staff member caring for him could hear him and respond. Upon interview on 3/17/25 at 11:10 a.m., registered nurse (RN)-A confirmed P3 did not have a call light. He just yelled and staff responded right away because the staffing table, where the nurses chart, was right outside his door. He stated P3 had never mentioned he felt that yelling was undignified. RN-A stated he didn’t know of another way P2 could call for assistance with his disabilities. P3 P3’s Home Health Certification and Plan of Care for period 2/18/25 – 4/18/25, indicated R3’s pertinent diagnosis was a nontraumatic intracerebral hemorrhage (ruptured blood vessel that bled into the brain). P3 required 24-hour supervision, anticoagulation (blood thinner) precautions, fall/safety and universal precautions. P3’s functional limitations were bowel/bladder incontinence, speech, ambulation, and weakness. P3’s activities permitted were transfer from bed to chair. P3’s mental status was oriented, depressed, and nonverbal. Upon observation and interview on 3/17/25 at 10:48 a.m., P3 was resting in his hospital bed. P3 had a tracheostomy tube (breathing tube) that was capped. P3’s room was to the backside of the home approximately 40 feet from the area were the staff congregated. There was one other patient’s room between P3’s room and the staff area. P3 communicated with head nods and could only speak saying yes, no, and hey. P3 stated “no” he didn’t have a call button. He demonstrated how he calls for staff by yelling “hey, hey!” He answered “yes” that he would use a call button or a bell for assistance. He stated “yes” at times he yelled for over thirty minutes waiting for staff. Upon interview on 3/17/25 at 10:58 a.m., licensed practical nurse (LPN)-A stated P3 would be able to use a call light, she was uncertain why he didn’t have one. Upon interview on 3/17/25 at 1:15 p.m., RN-C, the house manager stated staff responded to P2 by hearing him yell or if there is a crisis his respiratory machines beep loudly. P2 knows the staff so well that he yells out for staff by their name. RN-C was not aware P2 felt undignified by having to yell for assistance. RN-C stated P3 used to have a call light, but didn’t use it, he would yell-out, therefore the call light was taken away. Upon interview on 3/18/25 at 11:11 a.m., the director of nursing, DON stated for the residents who required 24-hour supervision in one of the agency’s homes should have a “documented legitimate reason” why they would not have some sort of call light and should not require yelling for assistance. An agency policy title Call Lights and Communication dated 5/17/24 indicated: Purpose The purpose of this policy is to establish guidelines for client communication and methods of ways to call for a nurse. Policy To ensure clients are able to communicate their needs and to call for a nurse as they need. PROCEDURE 1. Clients will be evaluated at the start of care to determine their ability to call for a nurse as needed as well as the most appropriate method of calling for assistance. 2. All clients live independently and have the right to refuse all ideas brought forward by staff. 3. As much as possible and willingness, clients will be encouraged to be out of their rooms and in common areas where staff are. 4. If the client chooses to, a monitor or a doorbell will be placed in the client’s room with the other end out by nurses so that nurses may hear clients needing assistance. 5. Nurses will also perform checks with clients throughout the shift to ensure the client’s safety and well-being.”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review the facility failed to provide the services identified in the plan of care for 1 of 4 patients (P3) reviewed. P3 was to be transferred from his bed to his chair. The staff was not getting him up and out of bed into his mechanical wheelchair. In addition, P3 was only receiving bed bathes and preferred a shower at least weekly or more often. P3’s Home Health Certification and Plan of Care for period 2/18/25 – 4/18/25 indicated R3’s pertinent diagnosis was a nontraumatic intracerebral hemorrhage (ruptured blood vessel that bled into the brain). P3 required 24-hour supervision, anticoagulation (blood thinner) precautions, fall/safety and universal precautions. P3’s functional limitations were bowel/bladder incontinence, speech, ambulation, and weakness. P3’s activities permitted were transfer from bed to chair. P3’s mental status was oriented, depressed, and nonverbal. The plan did not indicate how often P3 was to be transferred from his bed to his chair. P3’s clinical notes dated 2/18/25 – 3/17/25 indicated on 2/14/25 P3 was up in his chair watching television. On 3/9/25 P3 refused to get into his wheelchair. On 3/13/25 P3 refused to get in his wheelchair. The rest of P3’s notes covering all three shifts per day did not indicate P3 had gotten out of his bed into his chair or had been asked to get up and if he refused. Upon observation and interview on 3/17/25 at 10:48 a.m. P3 was resting in his hospital bed. P3 communicated with head nods and could speak “yes, no, and hey”. P3 stated “yes” he wanted to get up out of his bed. He stated “yes” right away he wanted to get out his bed. He stated “no” he hadn’t been out of bed for days at a time. He stated “yes” he would like to be up in his chair so he could electrically scoot around and go outside. In addition, P3 stated “yes” to he would like a shower and not a bed bath. Upon interview on 3/17/25 at 10:58 a.m. licensed practical nurse (LPN)-A stated P3 never got up when she was on duty. She didn’t get P3 out of bed because she he would want to do is go outside or shopping and he would get into trouble when he did. LPN-A stated she believed the reason P3 didn’t get into the shower was because he didn’t have a shower chair large enough. Upon interview on 3/17/25 at 11:10 a.m. registered nurse, (RN)-B stated P3 did not have a shower chair large enough, however the county was working on getting him one. He stated P3 had lived in the house about ten years. Upon interview on 3/17/25 at 1:15 p.m. RN-C, the house manager stated P3 does not have a shower chair to accommodate him for a shower. She wasn’t certain when he would get one. She stated the only time P3 got up was when he was going outside. She stated P3 will refuse to get up. P3 would go on outings and wheel himself into other people and had gotten kicked out of a nearby mall. P3 was able to be outside of the agency home with staff supervision. Upon interview on 3/18/25 at 11:11 a.m. the director of nursing (DON) stated patients’ should have their preferred bathing method followed if possible. He stated he would find it reasonable for P3 to get out of bed multiple times a week if not daily and staff should be asking him if he wanted to get into his chair if they were not. An agency policy titled Client Privacy Rights dated 10/4/24 indicated the agency provided each patient or the client’s representative with a copy of the client’s Bill of Rights. The Agencies Home Care Bill of Rights undated indicated the client had the right to receive all services on the plan of care.”

“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 observation, interview, and record review the home health agency (HHA) failed to include all types of equipment required on the plan of care for 3 or 4 patients (P1, P3 and P4) who were observed to have side rails attached to their hospital beds and no documentation found on their care plans. P1 P1’s Home Health Certification and Plan of Care for period 3/6/25 – 5/4/25, indicated P1’s diagnosis was muscular dystrophy (a genetic disease that causes progressive weakness and muscle mass. P1 required 24 hours supervision, fall/safety precautions, transfer precautions, universal precautions. P1’s functional limitations were bowel/bladder incontinence, paralysis, ambulation and endurance. Activities permitted were transfer bed/chair. P1’s mental status was oriented. P1’s durable medical equipment (DME) and supplies listed were an elevated toilet seat, hospital bed, Hoyer lift (mechanical lift), respiratory equipment and a wheelchair. P1’s plan of care did not indicate he had bilateral half side-rails on his hospital bed. Upon observation and interview on 3/17/25 at 10:00 a.m., P1 was well-groomed lying-in his hospital bed covered with a sheet. He had bilateral half side rails at the head of his hospital bed which were in the upright position. Upon interview on 3/17/25 at 11:10 a.m., registered nurse (RN)-A stated P1 is able to minimally use his side rails to turn himself and grab onto the rails with cares. He was not certain what P1’s care plan indicated. He stated the case manager completed the care plans. P3 P3’s Home Health Certification and Plan of Care for period 2/18/25 – 4/18/25, indicated R3’s pertinent diagnosis was a nontraumatic intracerebral hemorrhage (ruptured blood vessel that bled into the brain). P3 required 24-hour supervision, anticoagulation (blood thinner) precautions, fall/safety and universal precautions. P3’s functional limitations were bowel/bladder incontinence, speech, ambulation, and weakness. P3’s activities permitted were transfer from bed to chair. P3’s mental status was oriented, depressed, and nonverbal. P3’s DME was a hospital bed, Hoyer lift, respiratory equipment and a wheelchair. P3’s plan of care did not indicate he had bilateral half side rails on his hospital bed. Upon observation and interview on 3/17/25 at 10:48 a.m., P3 was resting in his hospital bed with bilateral half side rails at the head of his hospital bed which were in the upright position. Upon interview on 3/17/25 at 10:58 a.m., licensed practical nurse (LPN-A) was not certain how P3’s care plan read in regard to side rails. P4 P4’s Home Health Certification and Plan of Care for period 2/2/25 – 4/2/25, indicated P4’s pertinent diagnoses were quadriplegia (loss of movement of all four limbs) and anoxic brain damage (brain completely deprived of oxygen). P4 required 24-hour supervision, aspiration precautions, safe transfers, and universal precautions. P4’s functional limitations were bowel/bladder incontinence, contractures (hardening of muscles and tendons), paralysis, ambulation, speech, and endurance. Activities permitted were up as tolerated and transfer from bed to chair. P4’s mental status was identified as non-verbal. P4’s DME included a bed overlay (a mattress topper for pressure ulcers and support), hospital bed, Hoyer lift, respiratory equipment and a wheelchair. P4’s plan of care did not indicate P4 had bilateral half side rails on her hospital bed. Upon observation on 3/17/25 at 10:35 a.m., P4 was lying in bed under a blanket. P4 had bilateral half side rails at the head of her hospital bed in the upright position. Upon interview on 3/17/25 at 12:04 p.m., RN-B stated she was uncertain on what was on P4’s plan of care. Upon interview on 1/17/25 at 1:15 p.m., RN-C, the house manager stated she was aware the side rails were not on the plan of care for physician orders. She stated she didn’t realize the side rails needed to be. Upon interview on 1/17/25 at 3:05 p.m., the Administrator stated a lot of the side rail assessments occur when patients are in the hospital if the rails are warranted and ordered prior to admission. The agency used those recommendations and orders and not orders or notification to the attending provider when the patients were in the agencies living centers. An agency policy titled Practice Policies Restraints dated 11/15/24, indicated: All equipment and/or supplies deemed necessary for the client’s safety must be ordered by the physician. A doctor must medically order any type of restrictive equipment along with the proper use.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on observation, interview, and record review the home health agency (HHA) failed to assess and educate the patient and/or caregiver on professional standards of practice regarding bedrail use for 3 of 4 patients (P1, P3, and P4) observed to have side rails attached to their hospital bed. A Food and Drug Administration (FDA)website regarding bedrail safety viewed 3/17/25, https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/BedRailSafety/ucm362848.htm indicated: Education /Training Hospitals, long term care facilities, and home health care providers should provide education and training about bed rail use to assist in creating and implementing a safe and comfortable sleeping environment for their patients. It is recommended that the education and training be directed toward the following groups: • Staff • Patient/family • Physicians, including medical directors and physician extenders such as physician assistants and nurse practitioners • Long term care ombudsman • Regulatory agencies or representatives Bed Rail Safety Guidelines If it is determined that bed rails are required and that other environmental or treatment considerations may not meet the individual patient’s assessed needs, or have been tried and were unsuccessful in meeting the patient’s assessed needs, then close attention must be given to the design of the rails and the relationship between rails and other parts of the bed. 1. The bars within the bed rails should be closely spaced to prevent a patient’s head from passing through the openings and becoming entrapped. 2. The mattress to bed rail interface should prevent an individual from falling between the mattress and bed rails and possibly smothering. 3. Care should be taken that the mattress does not shrink over time or after cleaning. Such shrinkage increases the potential space between the rails and the mattress. 4. Check for compression of the mattress’ outside perimeter. Easily compressed perimeters can increase the gaps between the mattress and the bed rail. 5. Ensure that the mattress is appropriately sized for the selected bed frame, as not all beds and mattresses are interchangeable. 6. The space between the bed rails and the mattress and the headboard and the mattress should be filled either by an added firm inlay or a mattress that creates an interface with the bed rail that prevents an individual from falling between the mattress and bed rails. 7. Latches securing bed rails should be stable so that the bed rails will not fall when shaken. 8. Older bed rail designs that have tapered or winged ends are not appropriate for use with patients assessed to be at risk for entrapment. 9. Maintenance and monitoring of the bed, mattress, and accessories. P1 P1’s Home Health Certification and Plan of Care for period 3/6/25 – 5/4/25, indicated P1’s diagnosis was muscular dystrophy (a genetic disease that causes progressive weakness and loss of muscle mass). P1 required 24 hours supervision, fall/safety precautions, transfer precautions, universal precautions. P1’s functional limitations were bowel/bladder incontinence, paralysis, ambulation and endurance. Activities permitted were transfer bed/chair. P1’s mental status was oriented. P1’s durable medical equipment (DME) and supplies listed were an elevated toilet seat, hospital bed, Hoyer lift (mechanical lift), respiratory equipment and a wheelchair. P1’s plan of care did not indicate he had bilateral half side-rails on his hospital bed. Upon observation and interview on 3/17/25 at 10:00 a.m., P1 was well-groomed lying-in his hospital bed covered with a sheet. He had bilateral half side rails at the head of his hospital bed which were in the upright position. P1 stated he has minimum strength in his arms and was not able to reposition himself with the rails. He can hold on to the rails when staff are turning him to complete cares. He believed the rails were to keep him in from falling out of bed. P1 denied any formal education regarding the rails. Upon interview on 3/17/25 at 11:10 a.m., registered nurse (RN)-A stated P1 is able to minimally use his side rails to turn himself and grab onto the rails with cares. He was not certain what assessment or education was completed for sider ails. P3 P3’s Home Health Certification and Plan of Care for period 2/18/25 – 4/18/25, indicated R3’s pertinent diagnosis was a nontraumatic intracerebral hemorrhage (ruptured blood vessel that bled into the brain). P3 required 24-hour supervision, anticoagulation (blood thinner) precautions, fall/safety and universal precautions. P3’s functions limitations were bowel/bladder incontinence, speech, ambulation, and weakness. P3’s activities permitted were transfer from bed to chair. P3’s mental status was oriented, depressed, and nonverbal. P3’s DME was a hospital bed, Hoyer lift, respiratory equipment and a wheelchair. P3’s plan of care did not indicate he had bilateral half side rails on his hospital bed. Upon observation and interview on 3/17/25 at 10:48 a.m., P3 was resting in his hospital bed with bilateral half side rails at the head of his hospital bed which were in the upright position. P3 had a tracheostomy tube (breathing tube) that was capped. P3 communicated with head nods and could speak “yes,” “no,” and “hey.” P3 stated “yes” he used the side rails to turn himself in bed. He stated “no” he had not received any education from the staff and “no” he wasn’t certain why the rails were in place. Upon interview on 3/17/25 at 10:58 a.m., licensed practical nurse (LPN)-A stated P3 was able to use his side rails to hold himself during cares. She stated the rails were in place so P3 didn’t roll out of bed. LPN-A wasn’t certain what assessments or education the agency provided on the use of the side rails. P4 P4’s Home Health Certification and Plan of Care for period 2/2/25 – 4/2/25, indicated P4’s pertinent diagnoses were quadriplegia (loss of movement of all four limbs) and anoxic brain damage (brain completely deprived of oxygen). P4 required 24-hour supervision, aspiration precautions, safe transfers, and universal precautions. P4’s functional limitations were bowel/bladder incontinence, contractures (hardening of muscles and tendons), paralysis, ambulation, speech, and endurance. Activities permitted were up as tolerated and transfer from bed to chair. P4’s mental status was identified as non-verbal. P4’s DME was a bed overlay (a mattress topper for pressure ulcers and support), hospital bed, Hoyer lift, respiratory equipment and a wheelchair. P4’s plan of care did not indicate P4 had bilateral half side rails on her hospital bed. Upon observation on 3/17/25 at 10:35 a.m., P4 was lying in bed under a blanket. She had her eyes open, no movement and not responsive with her eyes during greeting. P4 had bilateral half side rails at the head of her hospital bed in the upright position. Upon interview on 3/17/25 at 12:04 p.m., RN-B stated P4 did not move at all and was not able to use the side rails. She believed the side rails were in place to keep P4 safe in bed. She was uncertain on what assessments and education the agency provided. Upon interview on 1/17/25 at 1:15 p.m., RN-C, the house manager stated she didn’t have the answer about the assessments the agency used and the criteria for side rails in homecare. She stated she knew the side rails were not on the plan of care for physician orders. Upon interview on 1/17/25 at 3:05 p.m., the Administrator stated a lot of the side rail assessments occur when patients are in the hospital, If the rails were warranted and ordered. The agency used those recommendations and orders and not orders or notification to the attending provider when the patients’ were in the agencies living centers. An agency policy titled Practice Policies Restraints dated 11/15/24 indicated: Policy Clients receiving homecare services and living in their own home have the right to be free of restraints and must have all other measures taken to avoid them. This includes any physical, chemical, or environmental form that restricts the client’s movement. If a form of restraint is needed, the client and/or guardian are agreeable, and all other options have been exhausted they must be ordered by the doctor and may only be used to ensure the immediate physical safety of the patient, staff or others and must be discontinued at the earliest possible time. In the event there are safety concerns, family members will be asked to assist to keep the client safe. Definitions Physical restraints are defined as: Any manual method or physical or mechanical device, material or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body. Restraints are considered a form of medical treatment. 2. Side Rails are not a restraint a. When used to prevent the patient from sliding out of bed with beds with certain therapeutic surfaces, and other beds that have slippery surfaces b. When used with patients who are experiencing involuntary movements c. When used with patients who are not physically capable of getting out of bed regardless of whether side rails are raised or not d. When padded and raised for Seizure Precautions Procedure 1. If an employee is concerned over the safety and the well-being of a client, they should first discuss with the supervising nurse who will involve family as necessary and assist with the implementation of alternative measures that may be provided for the client safety. Physicians and case managers will be included and updated as necessary. 2. Other methods will be used in the effort to keep the client safe. These may include but are not limited to more frequent monitoring, using a companion, sitter, distraction, redirection, etc. 3. Prior to any form of restraint, the family will be asked to assist staff in keeping the client safe. 4. If the concerns are not relieved by alternative methods a care conference will be held to determine the next plan or option. 5. The client physician will be involved throughout the process to monitor the condition changes to address any medical or behavioral concerns. 6. All equipment and/or supplies deemed necessary for the client’s safety must be ordered by the physician. 7. In the event of a form of restraint being necessary it must follow the following guidelines. a. All other methods for client safety have been tried and documented. b. The client and/or guardian are made aware of the situation and agrees. If either party disagrees, no form of restraint may be allowed. c. A doctor must medically order any type of restrictive equipment along with the proper use. d. Staff must be present to always monitor and document the occurrence. e. The restraint must be removed as soon as it is safely able to.”

“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 agency failed to establish a plan of care with patient-specific measurable outcomes and goals for 2 of 3 patient’s (P1 and P3) reviewed. Findings include: P1’s vulnerability assessment dated 9/28/22 indicated P1 had suicidal ideation. P1’s Home Health Certification and Plan of Care dated 5/20/24 – 7/18/24 indicated P1’s diagnoses were dissociative identity disorder (a mental health condition where a person has two or more separate identities) and post-traumatic stress disorder, chronic. P1 was seen by the agency for weekly skilled nursing visit for skilled observation, assessment, evaluation of vital signs and respiratory status. P1 had specific orders to teach him the name of the medications, purpose, dose, schedule, side effects, medication set-up and signs and symptoms to report to the nurse. P1’s goals were identified as: P1 will have vital signs within normal limits and clear lung sounds. P1 will verbalize/demonstrate taking meds as prescribed by MD and set-up by Registered nurse (RN) in locked medication machine. P1 to report signs and symptoms of urinary tract infection (UTI) to RN or physician. Client to remain free of UTI’s. P1’s goals did not identify any specific patient care goals on managing his mental dissociative identity disorder or his post-traumatic stress disorder or P1’s suicidal ideation, eating disorder, attention deficit hyperactive disorder (ADHD), insomnia, or borderline personality. Upon interview on 7/1/24 at 4:13 p.m. P1 stated he was not certain what the agency had for goals for him. He stated if he wrote his own goals, they would be to feel balanced and not have the highs and lows he had. Upon interview on 7/2/24 at 8:15 a.m. Registered nurse (RN)-A stated she asked P1 “all the time” about his mental health and suicidal ideation, but probably did not chart much about it because it was not on the care plan. She stated she was mainly in the home for safe medication administration. “He had tons of mental health support.” Upon interview on 7/2/24 at 9:10 a.m. (RN)-C, P1’s primary care nurse stated P1’s diagnoses were depression, chronic post-traumatic stress disorder, anxiety, sexual assault, dissociation identity disorder, borderline personality disorder, insomnia, human papilloma virus (HPV) anogenital, lactose intolerance, osteopenia, vitamin D deficiency and transsexualism. Upon interview on 7/9/24 at 10:15 a.m. P1’s Psychiatric Nurse Practitioner (NP) stated she has never had communication with the agency. She stated she sees P1 in clinic and gives him multiple goals, goals at each visit. “Goals are an important strategy in treating mental illness.” She stated working with the skilled nurse who sees the patient in the home setting and reporting to her is her expectation. She did not know why this agency did not reach out to like others do. P3’s Home Health Certification and Plan of Care dated 5/10/24 -7/8/24 indicated P3’s diagnoses were bipolar disorder and fibromyalgia. P3 was on a low sodium diet. P3 was seen by the agency for weekly skilled nursing visits for skilled observation, assessment and evaluation of vital signs and respiratory status. Specific orders to teach client, name of med, purpose, dose, schedule, signs and symptoms, medication set-up and signs and symptoms to report to the nurse and or physician. P3’s goals were identified as: P3 will verbalize/demonstrated taking medications and set-up by nurse. P3 will have stable vital signs and clear lung sounds. P3’s goals did not identify any specific patient care goals on managing her bipolar disorder or the pain from fibromyalgia. P1 did not have any dietary goals regarding her low sodium diet. Upon observation and interview on 7/2/24 at 10:30 a.m. RN-A took P3’s vital signs and listened to her lungs. RN-A asked P3 her bowel and bladder status and appetite. No education was completed and P3’s mental health was not addressed. RN-A stated P3 is very much control that was the reason she did not inquire about her mental health status. Upon interview on 7/3/24 at 12:07 the director of nursing stated the agency should have a goal for specific diagnoses and especially if the client’s take medications in which the agency sets up. Upon interview on 7/3/24 at 1:41 p.m. the Administrator believed P1 and P3 had client specific goals and was going to check and email any findings. No additional documents were received regarding patient goals. An agency policy titled Service Polices Client Cares dated 11/2/23 indicated caregivers must comply with the client’s care plan that addresses each client’s preferences, daily needs, interest, activities, and personal goals as well as their medical needs.”

“Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; This Element is not met as evidenced by: Based on interview and record review the agency failed to notify the patient, the Primary care Practitioner (PCP) that the patient was considered being discharged for cause. In addition, the agency failed to notify the Independent Living Service (ILS) agency, the Patient Care Assistant (PCA) agency, the Mental Health case worker, the Licensed Psychologist, and the Psychiatrist when the discharge became imminent for 1 of 3 patients (P1) reviewed. Finding include: P1’s Home Health Certification and Plan of Care dated 5/20/24 – 7/18/24 indicated P1’s diagnoses were Dissociative Identify Disorder (a mental health condition where a person has two or more separate identities) and post-traumatic stress disorder, chronic. P1 was seen by the agency for weekly skilled nursing visit for skilled observation, assessment, evaluation of vital signs and respiratory status. P1 had specific orders to teach him the name of the medications, purpose, dose, schedule, side effects, medication set-up and signs and symptoms to report to the nurse. An agency grievance form dated 5/24/24 detailed account of occurrence on 5/24/24 indicated it was decided by the county case manager to switch to a new agency. The county and the hospital requested the agency to perform one more visit when the P1 discharged from the hospital 5/24/24 in the afternoon. P1 refused all available nurses and told the hospital he did not need a visit. P1 called the agency the morning of 5/25/24 saying he needed nurse to come out when the agency returned the call he did not answer, nor did he call back. The results of the investigation were that P1 found a new agency by the county and the agency was instructed to discharge from services. A physician order dated 5/31/24 at 3:30 p.m. indicated P1 went to the emergency department on 5/23/24 for taking too many of his PRN (as needed) medications, Flexeril (pain medication and meclizine (antihistamine to treat motion sickness and vertigo). P1 reported he was angry and upset and did not know what else to do. P1 reported many times that he was not suicidal, just angry. Agency is working with the county case manger to find a new nursing agency. P1 refused any nurse available for a nursing visit. Discharging client from nurse visits and agency. Upon interview on 7/1/24 at 4:13 p.m. P1 stated he was not aware he had been “formally discharged” from the agency. He stated he had refused the current nurse who he alleged verbally abused him and then had one other nurse who “couldn’t set-up my medications accurately.” He stated during his time with the agency he had one other who left the agency and he had seen his case manager registered nurse (RN)-B for nursing visits and really liked the nurse who left and RN-B. P1 denied any form of correspondence from the agency regarding a discharge. He stated he was currently without a nurse and was having assistance from his county case worker and a nurse practitioner for medication set-up, but he did not realize the discharge was permanent. Upon interview on 7/2/24 at 4:39 p.m. P1’s county case worker stated after P1 had an allegation of verbal abuse with his current agency registered nurse (RN)-A he refused to see her again. She stated the agency stated they did not have any other nurses in the area to work with P1, therefore the county case manager was working on finding a new agency for P1. Upon interview on 7/2/24 at 8:42 a.m. RN-B stated she was P1’s agency case manager but was not involved much in the discharge. She stated she was aware that the agency discharged P1 because the agency did not have a nurse for him. She stated she had seen P1 in the past on visits but was not available at that time. She denied awareness of who was prescribing P1’s psychiatric medication, was not aware of the specific other mental health workers P1 had in place to notify upon discharge. She stated the only person notified of the discharge was P1’s primary care physician. Upon interview on 7/2/24 at 4:40 p.m. P1’s mental health licensed practitioner stated she was aware that P1 did not have skilled nursing service because she found out that that P1’s county case worker and a “nurse practitioner” was assisting him with medication set-up. She stated with all the verbal abuse allegations, the medication overdose and the agency withdrawing skilled services that P1 was unsafe. She stated P1 had been stable for months prior to these current occurrences. Upon interview on 7/3/24 at 12:07 p.m. the county case worker supervisor stated she worked on P1’s case and stated P1 wanted a different nurse and the agency stated they did not have one. P1 stated he did not want that nurse he had and was asked to see her until a different nurse was found and P1 refused. She stated she was going off what P1 said that he has had three nurses with the agency, two of which he was dissatisfied with and on who had moved on. She stated the county is working on a new agency for P1 and she stated she did not tell the agency to not see him. “If they had a nurse that would have been great until we found someone.” Upon interview on 7/3/24 at 1:41 p.m. the Administrator stated the reason the agency discharged P1 was because they did not have any nurses available to see him and the county told them to discharge him. She stated she believed P1 had a new agency but denied sending a new agency any medical history. She was unable to produce documentation of notification to P1 regarding the discharge. Upon interview on 7/9/24 at 10:15 a.m. P1’s Psychiatric Nurse Practitioner (NP) stated she had been informed of P1’s discharge by P1’s county Community Access for Disability Inclusion (CADI) worker. She stated her and the CADI worker had been assisting P1 with his medication set-up as no other agency was in place. She stated P1 was not safe that is why the CADI worker and her stepped in. She stated she orders his medications weekly, so he does not have very many on hand. A facility discharge policy was requested however none was received.”

“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 record review the agency failed to report allegations of verbal abuse to the state agency immediately for 1 of 3 patients (P1) reviewed. P1 alleged that when discussing P1’s medication and suicidal ideation with registered nurse (RN)-A, RN-A allegedly stated to P1 “well when are you going to do it?” P1 stated he felt taunted by RN-A’s comment and P1 overdosed on his medications. Findings include: P1’s Home Health Certification and Plan of Care dated 5/20/24 – 7/18/24 indicated P1’s diagnoses were dissociative identity disorder (a mental health condition where a person has two or more separate identities) and post-traumatic stress disorder, chronic. P1 was seen by the agency for weekly skilled nursing visit for skilled observation, assessment, evaluation of vital signs and respiratory status. P1 had specific orders to teach him the name of the medications, purpose, dose, schedule, side effects, medication set-up and signs and symptoms to report to the nurse. Emergency Room visit after visit summary dated 5/23/24 indicated P1 was seen for intentional overdose of medications. The history of present illness indicated P1 had an interaction with his home care nurse around two months ago and apparently the nurse made negative comments about the patient’s chronic suicidal ideations. He continued to perseverate on the comment until recently when the home healthcare nurse made a similar comment. At which point, P1 to prove to the nurse that he was suicidal, took a handful of his medications. A facility investigation dated 5/24/24 indicated on 5/23/24 the agency received a voicemail from P1’s county case manager stating P1 had taken an overdose of his medications and was in the emergency department. In addition, there some dynamics going between P1 and RN-A which trigged him to take his prn (as needed) medications. The report indicated that on 5/24/24 P1 stated he asked RN-A if she wanted him to “off himself” because she was not placing his lithium medication (a mood stabilizer) in his medication set-up, and he reported she said, “when are you going to do it?” The agency spoke with RN-A, and she stated she was asking P1 about a suicidal plan, not asking him to hurt himself. Upon interview on 7/1/24 at 4:13 p.m. P1 stated on his home health nursing visit on 5/21/24 P1 told RN-A that she forgot to set-up his Lithium (a mood stabilizer) in medication box. He stated he told RN-A when he misses his lithium, he feels suicidal. P1 stated RN-A’s response was “So when are you going to do it?” P1 stated he was so angry following the visit with her that took “a bunch of medications.” P1 had called poison control questioning the number of medications he had taken and was advised call 911. P1 was taken to the emergency department. Upon interview on 7/1/24 at 4:39 p.m. P1’s county case worker stated P1’s weekly home healthcare nurse who was working with him per P1 had medication errors and P1 asked her if she was trying to make him hurt himself by now giving him his lithium and the nurses response was “when are you going to do it?” The case worker stated she did reach out to the administrator of the agency regarding the alleged verbal abuse and stated the administrator defended her nurse, by saying “I don’t see how this could be the case.” Upon interview on 7/2/24 at 8:30 a.m. RN-A stated P1 was very cunning, very bright, and very mentally ill. RN-A stated P1’s interpretation was tied to her function of medication set-up where he believed he should take all his medications and harm himself. RN-A stated she ran into P1 on 6/22/24 at a mutual church event where P1 confronted RN-A about saying “so when are you going to do it?” and RN-A stated, “I don’t believe I told you that.” RN-A stated during interview “I did not tell him to overdose.” Upon interview on 7/2/24 at 8:42 a.m. RN-B stated she spoke with P1 on 5/23/24 when he was in the emergency department and P1 told her that RN-A had made comments that made him feel like she wanted him to die. RN-B stated she was not certain about the exact interaction. RN-B stated she felt the interaction was a miscommunication and the agency had a team meeting and concluded the same thing. RN-B stated verbal abuse is reportable immediately, but due to the agencies conclusion of miscommunication it was not reported. Upon interview on 7/3/24 at 1:41 p.m. the Administrator stated she heard on 5/25/24 from the county case manager that P1 had been hospitalized with an overdose. She stated she was informed the P1 was blaming RN-A and she was confused how RN-A could be blamed. She stated did not report the allegations because it was RN-B who took the report from P1. She stated, “I didn’t feel like I could make the report because I didn’t know his allegations.” An agency policy titled Vulnerable Client dated 5/4/23 indicated if maltreatment, abuse or is suspected a report is called to the CEP (common entry point) immediately.”

“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 observation, interview, and record review the agency filled to provide an individual care plan that included all pertinent diagnoses, supplies and equipment required for 2 of 3 patients (P1 and P3) reviewed. Findings include: P1’s Home Health Certification and Plan of Care dated 5/20/24 – 7/18/24 indicated P1’s diagnoses were dissociative identity disorder (a mental health condition where a person has two or more separate identities) and post-traumatic stress disorder, chronic. P1 was seen by the agency for weekly skilled nursing visit for skilled observation, assessment, evaluation of vital signs and respiratory status. P1 had specific orders to teach him the name of the medications, purpose, dose, schedule, side effects, medication set-up and signs and symptoms to report to the nurse. P1’s pertinent medications and rationale for medications indicating a diagnosis: Melatonin 10 milligrams (mg) daily for insomnia Propranolol 10 mg daily for cardiovascular concern Raloxifene 60 mg daily for hormonal replacement Senna 8.6 mg daily as needed for constipation. Atomoxetine 80 mg tablets daily for central nervous system Atorvastatin 40 mg daily for anti-hyperlipidemic (high cholesterol and/or triglycerides) Bupropion 75 mg daily for depression Buspar 75 mg daily for anxiety Caffeine 100 mg daily for stimulation Cetirizine 10 mg daily for allergies Cyclobenzaprine 10 mg daily for muscle relaxation Fluoxetine 20 mg along with 40 mg daily for depression Guaifenesin 400 mg daily for insomnia Lithium 450 mg daily for anti-psychosis Meclizine 25 mg three times daily as needed for vertigo P1’s plan of care failed to list insomnia, any cardiovascular concerns, diagnosis for hormonal replacement, constipation, pain, central nervous system concerns, allergies, or vertigo. Upon interview on 7/2/24 at 9:10 a.m. (RN)-C, P1’s primary care nurse stated P1’s diagnoses were depression, chronic post-traumatic stress disorder, anxiety, sexual assault, dissociation identity disorder, borderline personality disorder, insomnia, human papilloma virus (HPV) anogenital, lactose intolerance, osteopenia, vitamin D deficiency and transsexualism. Upon interview on 7/9/24 at 10:15 a.m. P1’s Psychiatric Nurse Practitioner stated she prescribes all psychiatric medications. She was aware P1 had a home care agency, but the agency has never communicated with her. In going over P1’s medication she stated P1 had been on Adderall. She stated she had been titrating the Adderall since 4/2024 for attention deficit hyperactivity disorder (ADHD). She stated she would write her orders on a prescription and P1 gave the orders to his home health nurse. Adderall was not listed on P1’s care plan nor was the ADHD diagnosis. P3’s Home Health Certification and Plan of Care dated 5/10/24 -7/8/24 indicated P3’s diagnoses were bipolar disorder and fibromyalgia. P3 was on a low sodium diet. P3 was seen by the agency for weekly skilled nursing visits for skilled observation, assessment and evaluation of vital signs and respiratory status. Specific orders to teach client, name of med, purpose, dose, schedule, signs and symptoms, medication set-up and signs and symptoms to report to the nurse and or physician. P3’s DME and supplies were a cane and a walker. P3’s pertinent medications and rationale for medications indicating a diagnosis: Methotrexate 10 mg weekly for anti-metabolite (chemotherapy medications) MiraLAX oral powder, no dosage indicated, twice daily as needed for constipation Oxycodone 5 mg 5-10 mg every four hours as needed for pain Montelukast 10 mg at bedtime for respiratory status Pantoprazole 40 mg daily for gastric reflux disease Primidone 50 mg take 100 mg daily for nervous system agent Remicade 100 mg Intravenous injection Senna plus 50 mg 8.6 mg twice daily for constipation Spirolactone 100 mg daily for cardiovascular Trazodone 300 mg daily for sleep Trospium 60 mg daily for urinary antispasmodic P3’s care plan failed to list any type of diagnosis for required for chemotherapy, constipation, respiratory concerns, cardiovascular concerns, urinary concerns, or gastrointestinal concerns. Upon observation and interview on 7/2/24 at 11:00 a.m. registered nurse (RN)-A was setting up medications. RN-A placed 1 tablet of Carbidopa/Levodopa 25/100 mg three times. RN-A stated the Carbidopa/Levodopa was for Parkinsonian traits. RN-a was not certain if P3 was diagnosed with Parkinson’s disease. She stated she was not certain type of cardiovascular or respiratory concerns P3 was diagnosed with. She stated P3’s methotrexate was diagnosed for her pain, even though the care plan called it an anti-metabolite and she was aware of P3’s sleep and constipation concerns. The Carbidopa/Levodopa was not listed on the care plan nor were Parkinson’s concerns. Upon observation and interview on 7/2/24 at 11:30 a.m. an observation of P3’s home showed P3 had a MD2 machine (locked medication dispenser), shower chair, shower grab bars, a toilet raiser, and a lift chair in her home. RN-A stated P3 had those items in the home for “quite some time” and was not certain if it was on her care plan. RN-A completed P3’s visit without her laptop due to the laptop being repaired. Upon interview on 7/3/24 at 12:07 the director of nursing stated the agency should have a diagnosis for specific medications if the agency is setting them up and all supplies should be on the care plan. Upon interview on 7/3/24 at 1:41 p.m. the Administrator believed P1 and P3 stated the agency is not always why some specific medications are given, therefor they may not always be a diagnosis to coincide. She was going to review P1 and P3’s records since the agency had a new software system. No additional documents were received regarding patient diagnoses and/or equipment. An agency policy titled Service Polices Client Cares dated 11/2/23 indicated caregivers must comply with the client’s care plan that addresses each client’s preferences, daily needs, interest, activities, and personal goals as well as their medical needs.”

“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 agency failed to administer drugs in accordance with physician orders for 1 of 3 patients (P1). P1’s Psychiatric Nurse Practitioner’s (NP) expectation was for P1 to have all medication in his MD2 machine (a locked pill dispensing machine) or locked in his safe. Findings include: P1’s Home Health Certification and Plan of Care dated 5/20/24 – 7/18/24 indicated P1’s diagnoses were dissociative identity disorder (a mental health condition where a person has two or more separate identities) and post-traumatic stress disorder, chronic. P1 was seen by the agency for weekly skilled nursing visit for skilled observation, assessment, evaluation of vital signs and respiratory status. P1 had specific orders to teach him the name of the medications, purpose, dose, schedule, side effects, medication set-up and signs and symptoms to report to the nurse. Upon interview on 7/1/24 at 4:13 p.m. P1 stated when his home health nurse set-up his medications she sets-up seven full days in MD2 machine and will leave out three to five days of medications that he had access to. He stated the medications the nurse left out were scheduled and as needed medications. P1 stated the medications he used to overdosed were melatonin (for sleep), Flexeril (for pain) and meclizine (for vertigo). Upon interview on 7/2/24 at 8:15 a.m. Registered nurse (RN)-A stated she did leave “about” three days of medications out for P1. She stated the nurse prior to her was doing that so she did the same. RN-A stated the agency had an order to lock-up P1’s medications. RN-A was uncertain whether P1 had an order to leave any medications out. RN-A stated P1 told her that he overdosed on his Bupropion (antidepressant), Buspar (antianxiety), lithium (mood stabilizer), Flexeril and meclizine. RN-A stated RN-B the case managed stated it was o.k. to leave out the medications. Upon interview on 7/2/24 at 8:42 a.m. RN-B stated she was aware that the agency nursing staff was leaving out a “few days of emergency medication.” She stated P1’s Primary Care Physician (PCP) was aware medications were being left out. She stated the agency did not have a formal order, but they had been leaving medications out since P1’s admission from 2022 to now because that was what his former home care agency was doing. RN-B was unable to provide documentation of the PCP’s awareness of practice of leaving P1’s medications out versus having them all locked up on his safe. Upon interview on 7/2/24 at 9:10 a.m. RN-C, P1’s primary care nurse, stated P1’s PCP relayed to her that she was aware P1 had medication set-up in a lock box. She unaware of how P1’s psychiatrist wanted P1 to have access to his medications as they prescribed all psychiatric medications. Upon interview on 7/9/24 at 10:15 a.m. P1’s psychiatric nurse practitioner (NP) stated it was not safe for P1 to have his medications left out and she had been wondering how he had gotten a hold of medications when he overdosed. She stated she has never had communication with the agency. The NP would write her orders and give them to P1 or his county CADI worker to give to the agency. The NP stated since P1 had been discharged from the agency with no skilled service she is only prescribes him one weeks’ worth of medication and either herself or the CADI worker assist P1 via video to set-up the medications and make sure left-over medications are locked in the safe provided to him. Upon interview on 7/3/24 at 12:07 p.m. the director of nursing, DON stated it was expectation that any patient who needs a lock box would get a written order if any medications were placed in the lock box. Upon interview on 7/3/24 at 1:41 p.m. the Administrator was not certain if P1 had orders for “emergency medications” to be left out. She stated the agency is using a new software system and was going to look for orders. She did not forward any documents of any orders following the survey exit. An agency policy titled Service Polices Client Cares dated 11/2/23 indicated caregivers must comply with the client’s care plan that addresses each client’s preferences, daily needs, interest, activities, and personal goals as well as their medical needs.”

“Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on interview and record review the facility failed to assure communication with all practitioners involved in the plan of care for 2 of 3 clients reviewed (P1 and P3). Findings include: P1’s client profile dated 9/28/22 identified one physician, P1’s primary care physician (PCP), no other providers were listed. P1’s Home Health Certification and Plan of Care dated 5/20/24 – 7/18/24 indicated P1’s diagnoses were dissociative identity disorder (a mental health condition where a person has two or more separate identities) and post-traumatic stress disorder, chronic. P1 was seen by the agency for weekly skilled nursing visit for skilled observation, assessment, evaluation of vital signs and respiratory status. P1 had specific orders to teach the name of the medications, purpose, dose, schedule, side effects, medication set-up and signs and symptoms to report to the nurse. Upon interview on 7/1/24 at 4:13 p.m. P1 stated he had multiple worked involved with his cares. He stated he had a PCP, psychologist, psychiatrist, nurse practitioner for mental health, positive support team, patient care assistant (PCA) and independent living services (ILS). P1 stated they are all instrumental to his care. Upon interview on 7/2/24 at 8:20 a.m. registered nurse (RN)-A stated she was aware P1 had a psychiatrist and multiple counselors, but stated she was not the case manager, therefor she did not have correspondence with those caregivers. Upon interview on 7/2/24 at 8:42 a.m. RN-B P1’s case manager stated she was not certain who prescribed P1’s psychiatric medications. She stated P1’s visit nurses would know more about that. She believed P1’s PCP prescribed his psychiatric medications but was not certain. Upon interview on 7/2/24 at 9:10 a.m. RN-C, P1’s PCP’s clinical nurse stated the PCP does not order his psychiatric medications and provided the name of the psychiatrist who was in the clinic records from 4/2023. Upon interview on 7/9/24 at 10:15 a.m. P1’s Psychiatric Nurse Practitioner (NP) stated she prescribes all P1’s medications. She stated that she was aware P1 had a home care agency and she stated she worked through P1 and his county CADI worker with her orders as she had no communication with the agency. P3’s client profile dated 5/16/23 identified on physician, P1’s primary care physician, no other providers were listed. P3’s Home Health Certification and Plan of Care dated 5/10/24 -7/8/24 indicated P3’s diagnoses were bipolar disorder and fibromyalgia. P3 was seen by the agency for weekly skilled nursing visits for skilled observation, assessment and evaluation of vital signs and respiratory status. Specific orders to teach client, name of med, purpose, dose, schedule, signs and symptoms, medication set-up and signs and symptoms to report to the nurse and or physician. Upon interview on 7/2/24 at 10:30 a.m. P3 (via a professional interpreter) stated she has just switched primary care providers and she also sees a practitioner for her arthritis and a mental health provider. She did not know if her visit nurse RN-A was aware of the providers she sees. Upon interview on 7/2/24 at 11:00 a.m. RN-A stated P3 does have multiple providers as she see’s other providers on the medication bottles, she sets-up for P3. She stated her involvement is to call the pharmacy and reorder the medications. Upon interview on 7/3/24 at 12:07 p.m. the director or nursing (DON) stated the agency should have all providers on their orders, especially the ones who order medications for the clients. Upon interview on 7/3/24 at 1:41 p.m. the Administrator stated all the providers should be in the orders and she believed they were. The facility had gotten a new software system a few prior and she was going to look in the old system and search for them. She did not provide any documentation that the providers were found. An agency policy dated 11/2/23 titled Service Policies Client cares indicated it was the client’s responsibility to notify the provider of changes in their condition, to participate in the development of the plan of care, to follow the plan or care and to notify the provider of doctor appointments.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview and record review the facility failed to update the plan of care (poc) when there were changes to medications, for 1 of 2 (P5) patients observed during medication set-up. P5’s POC dated 10/5/23 to 12/3/2023, indicated P5 was on Donepezil (medication for dementia) 5mg by mouth at night, iron sulfate 325mg by mouth daily and Loratadine (medication for allergies) 10mg by mouth daily. The POC lacked the medication Galantamine (medication for Dementia) by mouth daily. During medication setup observation on 11/7/23 at 2:35 p.m., registered nurse (RN)-A placed the medication galantamine in the patient medication box for each day, but failed to place the medications donepezil, iron sulfate or loratadine in the medication box for each day. During interview on 11/7/23 at 2:48 p.m., RN-A stated she placed the medications in the medication box based on what was in the locked medication case instead of the POC. RN-A reviewed P5’s POC and acknowledge Donepezil, iron sulfate and loratadine were medications no longer taken and galantamine was a medication that was taken currently and was not on the POC. The case manager was responsible to update the POC and remove any old medications that were not given anymore when the recertification visit was performed. For new medications, they should be updated when they are made aware of the new medication. During an interview on 11/8/23 at 10:11 a.m., the branch clinical manager (BCM) stated medications would be placed in the medication box based on the active medication list, which was transferred over from the POC. When nursing would set up medications each week, they would only place medications on the POC into the medication box for patients to take. If a medication was discontinued the nurse would remove it from the POC right away and any new medications would be added to the POC when they are ordered. Facility policy Medication Administration last reviewed 3/8/23, indicated a comprehensive medication assessment would be completed upon admission, with each recertification and with any changes in the medication review.”