Every finding on record at Tender Loving Care Health Care Services of Erie Niagara, LLC

The following statement of deficiencies represents the results of a partial extended re-certification survey of Amedisys Home Health Care Certified Home Health Agency (CHHA) conducted on 09/11/2023 to 10/06/2023 and included complaint investigation # 98840. A standard re-certification survey was initiated on 09/11/2023. Deficient practices were identified within Level I standards G-574 (Plan of Care) resulting in a partial extended survey. The survey consisted of a review of seventeen (17) clinical records, including six (6) discharged records, fifteen (15) personnel records for professional and paraprofessional personnel, two (2) contracts, and seven (7) observational home visits. The survey included a review of pertinent policies and procedures, Quality Improvement Committee Meeting minutes for the past twelve (12) months, agency’s Admission packet, the Emergency Preparedness Plan, and Complaint Log. Pre-survey activities consisted of review on 09/06/2023 of the agency’s Health Commerce System (HCS) account, Home Care Worker Registry, Criminal History Record Check, Certification and Survey Provide Enhanced Reports (CASPER) for the period of 06/01/2022 to 05/31/2023, and the agency’s compliance with submission of statistical reports and emergency drills. The Director of Operations (DOO), Area Vice President (VP) of Operations, Area VP of Clinical, Clinical Managers, and professional and paraprofessional staff were reviewed. Findings were reviewed at the exit conference on 10/06/2023. The complaint was substantiated. The following deficiencies are identified as a result of the survey: G-460, G-478, G-480, G-514, G-520, G-526, G-536, G-544, G,-546, G-572, G-574, G-578, G-580, G-586, G-590, G-598, G-608, G-642, G-714, G-716, G-718, G-754, G-984, G-1012, G-1024, J-208, J-1156, J-1168, J-1260, J-1301, J-1304, J-1328, J-1412, J-1416, J-1420, J-1424, J-1426, J-1428, J-1436, J-1440, J-1444, J-1456, J-1460, J-1464, J-1504, R-510, and R-610.

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview the agency failed for one (1) of one (1) patient refusing services (Patient #1) to educate the patient/caregiver on the risks and potential outcomes of refusing services, failed to notify the physician in a timely manner about refusal of services, and failed to document the measures and interventions the agency took in order to obtain patient participation in the plan of care. Failure to educate, inform and put measures in place to obtain patient participation with the plan of care has the potential for patient harm. The agency failed to educate the patient/caregiver on the risks and potential outcomes of refusing services, failed to notify the physician in a timely manner about refusal of services, and failed to document the measures and interventions the agency took in order to obtain patient participation in the plan of care as evidenced by the following: Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. The patient was initially admitted to agency services for Physical Therapy (PT) only on 11/12/2022 for deconditioning after a COVID-19 infection. On 12/23/2022 during a coordination of care telephone call due to a winter storm emergency, the patient’s caregiver reported to the PT that there was no heat or power at the patient’s home. On 01/03/2023 the PT documented that the patient had wounds on the left great toe and the right great toe, and a nursing evaluation was requested. On 01/04/2023 the patient went to the Emergency Room for evaluation of the left and right great toes. The patient was diagnosed with frostbite of the left and right great toes and was discharged home the same date. 01/05/2023, Skilled Nursing (SN) services were initiated for wound care to the left great and right great toes. On 01/23/2023 a third wound, located on the left second toe, was identified. The wound was described as a scabbed area. The surrounding area was documented as slightly reddened and edematous. There is no documentation that would provide insight as to the possible cause of the wound. From 01/05/2023 to 03/20/2023 the SN (Employee M) conducted all SN visits and provided wound care. Review of the RN (Registered Nurse) Recert with Skill Visit dated 03/09/2023 revealed the patient met criteria for recertification and would continue to receive SN services for wound care to the three identified toe wounds. Review of the Home Health Certification and Plan of Care for certification period 03/12/2023 to 05/10/2023 revealed SN services were ordered as “1WK1, 2WK7, 1WK1, 1PRN.” Review of the SN Subsequent Visits dated 03/27/2023, 03/30/2023, and 04/03/2023 revealed a Licensed Practical Nurse (LPN) visited the patient and provided wound care. Review of the RN Visit + Sup (supervision) dated 04/06/2023 revealed that a different RN (Employee L) completed the visit. On that date, the RN provided wound care, but did not measure or document a comprehensive assessment of the three wounds. The RN documented that she was unable to assess the wounds, but did not document an explanation why the wounds could not be assessed. Review of the SN Subsequent Visits dated 04/10/2023, 04/13/2023, 04/06/2023, and 05/02/2023 revealed that wound care was provided by LPN’s on those dates. Review of the Coordination Notes dated 04/23/2023 at 10:15 AM for a missed visit on 04/21/2023 (2 days after the visit was to occur) revealed a missed visit note for 04/21/2023. The note revealed that the Clinical Manager was notified that the missed visit occurred because the patient’s granddaughter refused the visit and requested that the visit not be rescheduled, and the visit was to be rescheduled to the next Medicare week. Additional comments state that the granddaughter requests visit at 4 PM, but “SN was not available at 4 PM due to ectend3d [sic] visit with prior patient. SN received a text at 4:20 that no one was available at patient’s home for visit.” There is no evidence the patient’s physician was notified at that time. Review of the Coordination Note dated 04/26/2023 revealed the LPN documented that wound care was provided. The LPN documented “left wound with necrotic eschar wounds, right foot with small serosanguinous drainage. No odor associated with no signs or symptoms of infection….PT (patient) has positive support from granddaughter and daughter who provide all care…they are waiting a possible wound clinic appt (appointment).” Review of the Coordination Note dated 04/28/2023 revealed the RN documented “SN text granddaughter 4/27/23 to set up visit time. Granddaughter requests visit between 8A-9A. SN stated visit can be at 9:45 Granddaughter declined.” The RN documented a missed visit that was reported to the Clinical Manager because the caregiver refused, and the patient requested that the missed visit not be rescheduled. There is no documentation to show that the patient/caregiver was educated on the risks and potential adverse outcomes as a result of refusing services. Additionally, there is no documentation to show that the agency took measures to obtain patient participation with the plan of care. Furthermore, there is no documentation to show that the physician was notified that the visit was missed because the agency was unable to accommodate the caregiver’s request for visits to be made between 8 AM and 9 AM. Review of the Coordination Note dated 05/01/2023 revealed the Clinical Manager documented “Coordination of care completed. Recertification visit scheduled. Recertification for Skilled Nursing Services for continued wound care management if caregivers agreeable. There is no documentation to show who was involved in the coordination of care, the date and proposed time of the scheduled recertification visit, and whether the visit was scheduled with participation of the patient/caregiver. It is unclear who was involved in the coordination of care, and whether the patient/caregiver, and physician were involved and/or made aware of the date for the visit. Review of the Coordination Note dated 05/04/2023 at 05:53 PM revealed the RN documented that there was a missed visit on 04/28/2023 (6 days after the missed visit). The note shows that the missed visit was reported to an individual at the physician’s office that the granddaughter refused the visit, and the visit was not rescheduled. Notification to the physician’s office occurred 6 days after the missed visit. There is no documentation explaining why the caregiver refused, whether the agency took measures to obtain patient participation with the plan of care, whether the patient/caregiver was educated on the risks and potential adverse outcomes as a result of refusing services, and whether the physician was fully notified about the circumstances leading up to the missed visits. Review of the Coordination Note dated 05/08/2023 at 09:55 AM revealed the RN documented a missed visit for that date, and that a voice mail was left on the nurse line at the physician’s office for the physician. Additionally, the Clinical Manager was notified. It is documented that the patient requested that the missed visit not be rescheduled. Additional comments state “Granddaughter requests visits at 8 AM, will not negotiate time.” There is no documentation on that date that the RN contacted the patient/caregiver by phone or another form of communication to schedule the visit, and that as a result of the conversation, the patient/caregiver refused the visit. Additionally, there is no documentation to show that the patient/caregiver was educated on the risks and potential adverse outcomes as a result of refusing services. Furthermore, there is a lack of documented evidence that the agency made efforts to resolve the problems leading to the missed visits. Review of the RN-Discharge Data Collection Only-No Visit Made dated 05/08/2023 at 08:21 AM to 10:17 AM, revealed the assessment was completed for “discharge from agency.” There is no documented evidence that the patient/caregiver or physician were made aware of the agency’s decision to discharge the patient. Review of the Coordination Note dated 05/11/2023 at 09:38 AM [3 days after the patient was discharged from the agency] revealed the RN Clinical Manager documented “Patient’s [caregiver] called to complain about ‘the nurses not showing up.” This RN explained that the nurses have offered several alternate times that have been declined for visits and the only times available are between 8-9 AM and this is not always able to be accommodated. The [caregiver] explained that she works overnight, and refuses visits any other time between 8-9 AM. When the nurse was 15 min (minutes) late, because the exact time wasn’t met’ They refused the visit and said, ‘contact the agency.’ This RN explained that ranges for visits must be given as schedule changes and emergencies happen with patients and we are required to give a range of time for visits. Again [caregiver] was not satisfied with this response. [Caregiver] stated [agency nurse name] was the last person here last week on Monday and now her foot is turning black on top. This RN recommended that ‘she needs to go to the emergency room immediately.” [Caregiver] continued to yell and stated “I called to talk to [name of agency employee]’… [Name] RN for family practice (the physician’s office) contacted this RN as [caregiver] also called the doctor’s office. [Name] wanted to know what was going on so she could notify the doctor. This RN explained that several visit times have been offered but the patient’s [caregiver] only allows visits between 8-9AM, we have offered different times in the ‘morning’ as requested but those are declined…This RN discussed that we have also spoken to the daughter about the need for more assistance with the wounds, such as a wound clinic, or doctor as the treatment is not improving the overall wound…This RN explained that the feet have remained black/necrotic and non-healing and need physician intervention. The [caregiver] had not taken her to do this. When we found out about the wounds, they would only take her to the emergency department. This RN stated ‘I was going to contact APS (Adult Protective Services) as it has now been 3 weeks with multiple missed visits and I am concerned about who cares for her while [caregiver] is sleeping and the [second caregiver] is not available to come over and let the nurse in…” There is no documentation that the patient/caregiver was notified that the patient was actually discharged on 05/08/2023, or that the physician was notified of the patient’s discharge. Review of the Coordination Note dated 05/14/2023 at 09:17 PM revealed the RN documented a missed visit for 05/05/2023 (9 days after the visit was missed and 6 days after the patient was discharged). Review of the Coordination Note dated 05/16/2023 (8 days after the patient was discharged from the agency) revealed the agency mailed the patient a Notice of Medicare Non-Coverage (NOMNC). The RN documented that the NOMNC was “mailed due to multiple missed visits and certification lapse.” There is no documented evidence that the physician was notified of the discharge. During interview on 09/28/2023 at 10:41 AM the RN (Employee L) stated that the patient’s caregiver only wanted visits by 07:30 AM. During interview on 09/28/2023 at 10:41 AM the Clinical Manager stated the missed visits occurred because the caregiver only wanted the RN to visit between 8:00 AM and 9:00 AM or between 04:00 PM and 05:00 PM. When the RN arrived on 04/21/2023 at 04:20 PM, the patient’s caregiver sent a text to the RN to go back to the agency. The Clinical Manager explained that although it is not clearly documented, the family wanted the visit right at 04:00 PM. The Clinical Manager explained that on 05/11/2023 [3 days after the patient was discharged] the family called the agency and stated that they only wanted visits between 8 and 9 AM. The Clinical Manager stated that when she spoke with the patient’s caregiver that the caregiver would not change the times, and the caregiver did not want further visits if the agency could not accommodate the caregiver’s times. When asked how the physician was notified about the decision to discharge the patient based on missed visits, the Clinical Manager stated that she could not speak to that.

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure and staff interview for one (1) of one (1) patients (Patient #1) the agency failed to investigate a complaint made by the patient’s caregiver. Failure to investigate complaints has the potential for patient needs not being met and patient harm. Review of the agency policy and procedure entitled “Patient/Caregiver Grievance/ Complaint” last reviewed 12/14/2022 revealed “The agency is to initiate a complaint investigation within 10 business days of the agency’s receipt of the complaint and document all components of the investigation.” The agency failed to investigate a complaint made by the patient’s caregiver as evidenced by the following: Patient #1- This 98-year-old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. Review of the Coordination Note dated 05/11/2023 at 09:38 AM [3 days after the patient was discharged from the agency] revealed the RN documented “Patient’s granddaughter called to complain about ‘the nurses not showing up.” This RN explained that the nurses have offered several alternate times that have been declined for visits and the only times available are between 8-9 AM and this is not always able to be accommodated. The granddaughter explained that she works overnight, and refuses visits any other time between 8-9 AM. When the nurse was 15 min (minutes) late, because the exact time wasn’t met’ They refused the visit and said ‘contact the agency.’ This RN explained that ranges for visits must be given as schedule changes and emergencies happen with patients and we are required to give a range of time for visits. Again granddaughter was not satisfied with this response. Granddaughter stated [Kyerston] was the last person here last week on Monday and now her foot is turning black on top. This RN recommended that ‘she needs to go to the emergency room immediately.” Granddaughter continued to yell and stated “I called to talk to [Darcy]’… [Nicole] RN for family practice (the physician’s office) contacted this RN as granddaughter also called the doctor’s office. [Nicole] wanted to know what was going on so she could notify the doctor. This RN explained that several visit times have been offered but the patient’s granddaughter only allows visits between 8-9AM, we have offered different times in the ‘morning’ as requested but those are declined…” There is no documentation in the record that the patient/caregiver was notified of the patient’s discharge on 05/08/2023. There is also no documentation to show that the physician was notified of the patient’s discharge. Review of the agency Complaint/Concern Log and Complaint Reports for 2023 revealed there is no documentation that the complaint was investigated by the agency for this patient/caregiver that were not made aware of the discharge on 05/08/2023. During interview on 09/26/2023 at 11:13 AM the Director of Operations (DOO) stated that she followed up with the patient’s caregiver, and tried to call the caregiver back, but the DOO didn’t log the complaint.

Treatment or care CFR(s): 484.50(e)(1)(i)(A) (i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and This ELEMENT is not met as evidenced by: Based on review of the agency policy and procedure, agency Client Roster Report, Complaint Log, Complaint Reports and staff interview for four (4) of four (4) patients (Patients #’s: 18, 19, 20 and 21) involved in a complaint, the agency failed to ensure it conducted a complete investigation of all complaints involving care that is furnished inconsistently, inappropriately or fails to be furnished. Failure to investigate complaints thoroughly has the potential for patient harm. The agency failed to ensure it conducted a complete investigation of all complaints involving care that is furnished inconsistently or inappropriately as evidenced by the following: Review of the agency policy and procedure entitled “Patient/Caregiver Grievance/ Complaint” last reviewed 12/14/2022 revealed “The agency is to initiate a complaint investigation within 10 business days of the agency’s receipt of the complaint and document all components of the investigation...The Director of Operations/designee must documentation of all components of the investigation including actions to be taken to prevent further potential violations…The Director of Operations, or designee, is responsible for reviewing every complaint; determining the necessity of corrective action; and communication regarding the resolution with the client/patient/caregiver/ family member/consumer no later than 30 calendar days following the receipt of the complaint; as well as documenting all activities involved with the complaint, investigation, analysis, resolution and communications.” Specific to New York State, the policy states “The governing authority, or designee, will review each complaint with a written response to all written complaints and a written response to oral complaints if requested by individuals making oral complaints within 15 dates of receipt…The complaint log must include the date of receipt and resolution of all complaints.” I. A.) Patient # 19- This unknown aged patient with the diagnoses of Unspecified open wound right lower leg was admitted to the agency on 02/14/2023 (per the Client Roster Report). This patient resides in an Adult Living Facility. Review of the Complaint/Concern Log from 06/05/2023 to 06/26/2023 revealed two complaints were listed. The complaint corresponding to this patient is recorded on the Complaint Log as follows: - Date/Time” 06/05/2023, no time documented - Call Taken By: employee first initial and last name. - Complaint/concern received from (name, address & telephone number): first name of a non-employee individual, with title of the individual and name of a facility. - Area of concern: service. - Date Completed: 06/06/2023 - Completed by whom: name of agency employee. Review of the Complaint Report revealed the complaint was dated 06/05/2023 (Monday) at 09:19 AM. Description of the complaint revealed that a telephone complaint was received by the agency on 06/05/2023 at 06:59 PM the complainant reported that the agency’s on-call was not able to send an agency nurse out to the facility to change the patient’s clogged Foley Catheter on “05/2023.” The agency contacted the Director of Nursing (DON) at the Adult Living Facility (ALF), who informed agency staff that the DON was going to flush the Foley catheter and contact the agency if a Skilled Nursing visit was needed for a Foley catheter change. The DON called the agency and reported that she “was unable to flush Foley. She changed Foley and noted foul smelling discharge 900 ml urine return.” Additionally, the DON reported that she would contact the patient’s physician for an antibiotic. The DON also reported that the patient did not have any more Foley supplies. The DON was advised to contact the agency’s on-call with any further needs. Under intervention/Resolution Comments, the following is documented: “N/A (not applicable) …[complainant] of facility called triage and said [person at ALF] would attempt to flush the catheter [person at ALF] was instructed by the triage nurse to call back after [person at ALF] could not get the catheter to flush. DON called triage nurse back after [person at ALF] was unable to flush catheter and then changed the catheter herself. She called back to report foul urine.” There is no investigation into why the agency could not send an agency nurse to provide Skilled Nursing services to the patient residing in a non-medical facility. During interview on 10/05/2023 at 09:30 AM the Director of Operations (DOO) stated that the agency was following the patient for Foley catheter care, catheter flushes and changes. When asked why the agency could not provide an agency nurse to flush and/or change the Foley catheter, the DOO stated that she believed that the call came in after hours, and the facility person told the agency’s triage nurse that the facility person would attempt to flush the Foley. The facility person was advised to contact the agency’s on-call with any further needs. The DOO explained that from 05:00 PM to 08:00 AM a triage nurse answers phone calls, and if the nurse feels there is a need for a nurse, then a nurse would be sent out. The DOO stated that if the facility person couldn’t flush the Foley, then an on-call nurse would be called. The DOO stated she would provide the clinical portion of the patient’s record pertaining to the complaint as requested; however no further information was provided. B.) Review of the Complaint Concern Log dated 07/19 (no year documented) to 09/6 (no year documented) revealed three complaints logged. The complaint corresponding to this patient is unknown because there are two complaints with the same information as follows: - Date/Time 09/6 (no year is documented). Additionally, no time is documented. - “Call Taken By: the employee’s first initial and last name is documented. - Complaint/concern received from (name, address & telephone number): A Name is documented. -Area of concern: wound care - Date Completed: 9/8/23. - Completed by whom: first initial and last name of employee. Review of the Complaint Report dated 09/06/2023 at 02:17 PM revealed “Description: Complainant reports nurse came to do wound care ‘over the weekend’ (09/04/2023). Reported to ALF staff that wound care was completed but that she couldn’t get the bleeding to stop. ALF LPN went to check on patient after the Amedisys nurse left. Noted the room was ‘covered in blood’ looked like a massacre.’ Patient had blood all over him and his clothes. Patient’s Foley catheter bag was being dragged across the floor. ALF LPN reports that she applied a bandage with some pressure to stop the bleeding. Upset that Amedisys did not provide complete report, nor did she ask for assistance.” Interventions: “provide education to staff member…disciplinary counseling.” Intervention/Resolution Comments: “Educated LPN to proper care coordination following visit with adverse findings-visit resolution, working with caregiver/ALF staff to resolve as possible; to include notification to clinical manager or clinical manager on-call; notification to case manager. Continued follow-up with appropriate care provider.” The follow-up comments revealed the agency LPN reported that the patient has two new lacerations, which the patient dressed with 4 foam dressings. The LPN had difficulty controlling the bleeding and recommended that the patient have the lacerations evaluated further either in an urgent care setting or ER (Emergency Room), as the lacerations needed further care and possibly sutures. The LPN re-dressed the wounds, and when the LPN attempted to clean, the patient refused further care. The LPN reported that the patient’s physician was contacted but the LPN could only leave a message. The LPD did not notify the on-call supervisor or supervisor. There is no documentation about the care the agency is to provide for the patient, what wound care is ordered, whether the LPN obtained an order to treat the lacerations, how the lacerations were obtained, whether an RN evaluated the patient after the complaint, or spoke with the patient/ caregiver/ facility staff to resolve the complaint. Additionally, there is no date of resolution of the complaint. The last entry in the Complaint Report is dated 09/11/2023. The date of resolution documented on the complaint log, for both complaints initiated on 09/06, is 09/08/2023. During interview on 10/05/2023 at 09:09 AM the Director of Operations (DOO) stated that in regard to the two identical complaint entries on the Complaint Log, one would not know which complaint entry corresponded with this complaint, but the follow-up on the Complaint Report has the information. When asked the date the complaint was resolved, the DOO stated that “It looks like 09/11/2023.” When asked whether the Registered Nurse conducted a follow-up visit to assess the patient, the DOO stated that she would have to look into it. When asked whether the lacerations were new, and whether the agency had orders to treat, the DOO stated that she would have to look into that. The DOO stated that the patient refused to go to the ER, and the bleeding had stopped. The DOO stated she would provide the clinical portion of the patient’s record pertaining to the complaint as requested; however no further information was provided. II. Patient # 18- This unknown aged patient with the diagnosis of infection following a procedure superficial incisional surgical site was admitted to the agency on 11/29/2022 (per the Client Roster Report) This patient resides in an Adult Living Facility. Review of the Complaint Concern Log dated 07/19 (no year documented) to 09/6 (no year documented) revealed three complaints logged. The complaint corresponding to this patient is unknown because there are two complaints with the same information as follows: - Date/Time 09/6 (no year is documented). Additionally, no time is documented. - “Call Taken By: the employee’s first initial and last name is documented. - Complaint/concern received from (name, address & telephone number): A Name is documented (the same name for the wo complaints dated 9/6). -Area of concern: wound care - Date Completed: 9/8/23. - Completed by whom: first initial and last name of employee. Review of the Complaint Report dated 09/06/2023 at 02:13 PM revealed under description of the complaint “Nurse completed wound care over the weekend but did not change the dressing on the LLE (left lower extremity). The patient was very upset about it and asked the ALF staff to change the dressing.” Interventions are documented as” “F/U (follow-up) with client/caregiver” and “Provide education to staff member.” Under Intervention/Resolution Comments, there is no documentation. Follow-up comments are documented as “LLE wound not documented and no orders for LLE wound care.” Additionally, there is no documentation that a message was left for the nurse that provided the patient care on that date, and the Case Manager. Under Complaint Log Updates, the following is documented: -09/11/2023 at 01:14 PM: “Processed 09/11/2023…Complaint Intervention: F/U with client/caregiver/family…Complaint Intervention: provide education to staff member…Complaint Prevention: Investigate complaint as soon as possible…Complaint Prevention: Maintain complainant’s confidentiality…Complaint Prevention: Document complaint, resolution and communications.” There is no documented evidence that all the components of an investigation were completed. It is unknown what care was completed on that date, whether the Skilled Nurse was aware that the patient had a wound on the LLE, had orders to treat the LLE wound, or whether the Skilled Nurse failed to follow the plan of care. There is also no documented evidence that the agency followed up and sent a Skilled Nurse to assess the patient and provide care accordingly, whether the agency followed up with the patient/caregiver, ALF, or the physician. During interview on 10/05/2023 at 09:05 AM the Director of Operations (DOO) stated that the facility (ALF) nurse put a dressing on the wound located on the LLE, and the physician was contacted about wound care orders. Additionally, the information should be documented on the complaint log and report. The DOO stated she would provide the clinical portion of the patient’s record pertaining to the complaint as requested; however no further information was provided. III. Patient #20- This unknown aged patient with unknown diagnoses was admitted to the agency on 07/01/2023 and discharged on 08/29/2023 after the patient was transferred to a hospital, and then a skilled nursing facility (per the agency’s discharge roster). Review of the Complaint Concern Log dated 07/19 (no year documented) to 09/6 (no year documented) revealed three complaints logged. The complaint corresponding to this patient is as follows: - Date/Time 07/19 (no year is documented). Additionally, no time is documented. - “Call Taken By: the employee’s first initial and last name is documented. - Complaint/concern received from (name, address & telephone number): An individual’s first initial and last name is documented. -Area of concern: “pt frequency.” - Date Completed: 7/20 (no year documented) - Completed by whom: first initial and last name of employee. Review of the Complaint Report dated 07/19/2023 at 01:51 PM revealed: Description: the agency received a call from an individual regarding “a concern about patient’s care.” The individual voiced a complaint about the patient’s “scheduled frequency and lack of knowledge regarding medication frequency. [The individual] said that patient had newly formed blisters on her RUE (right upper extremity) that needed compression and that the patient had a fall on 07/17/2023 which she (the patient) wad seen in the ED (Emergency Department) for. The patient had notified her SN on 07/18/2023 of the fall, but no changes in medications or no injuries. SN (Skilled Nurse) scheduled for 07/19/2023. [The individual] felt this was an inappropriate frequency and that nursing should have been to see patient on 07/18/2023. [The individual] was also concerned that PT (Physical Therapy) was only scheduled to see patient 2 x/ week and stated that the patient needed SN 3 X/ week. I explained that all orders/frequencies have been reviewed with the ordering MD and accepted. I told her I would review her concerns with CM (clinical manager) and F/U (follow up). Under Interventions: “After speaking with CM there have been issues with patient complaining about staff and asking for new PT’s. SN aware of edema to RUE, but no blisters seen last visit. Plan was to discharge for no skilled nursing need. CM did follow up call to [The individual]. There is no investigation documented. It is unknown whether the agency addressed the complainant’s issues and complaints, whether a follow-up visit was conducted to assess the patient to determine whether there are injuries related to the fall, blisters, assess the extent of the RUE edema, medication changes, determine the patient’s actual skilled needs and follow-up with the physician if needed. During interview on 10/05/2023 at 09:16 AM the Director of Operations (DOO) stated that there was follow-up with the Clinical Manager and the person who filed the complaint. When asked whether a follow-up visit with the patient was completed, the DOO stated that she would need to look that up. The DOO stated that the Registered Nurse saw the patient on 07/19/2023 and the patient was noted to have a ruptured blister on the right forearm with an intact blister. The DOO stated that the patient was discharged on 08/23/2023 with the patient to follow-up with the patient’s primary care physician two days later. The DOO stated she would provide the clinical portion of the patient’s record pertaining to the complaint as requested; however no further information was provided. IV. Patient # 21- This unknown aged patient with the diagnosis Peripheral Vascular Disease, unspecified was admitted to the agency on 05/26/2023 (per the agency’s Client Roster Report). Review of the Complaint/Concern Log from 06/05/2023 to 06/26/2023 revealed two complaints were listed. The complaint corresponding to this patient is recorded on the Complaint Log as follows: - Date/Time” 06/26/23, no time documented - Call Taken By: employee first initial and last name. - Complaint/concern received from (name, address & telephone number): RN did not do VS. - Area of concern: Performance - Date Completed: 06/27/2023 - Completed by whom: name of agency employee. Review of the Complaint Report received by the agency on 10/05/2023 revealed the following: Description “Reported that on 06/21/2023 the nurse came in and did wound care did not do any vital signs, (vs) are documented on the visit.” There is no investigation documented, no Intervention/Resolution Comments documented, and no date of resolution documented.” During interview on 10/05/2023 at 09:30 AM, the Director of Operations (DOO) was made aware that the Complaint Report was not provided when requested. The DOO stated that the report would be sent as requested.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and interviews with staff, for one (1) of eleven (11) (Patient #7), the agency failed to ensure the Registered Nurse (RN) conducted an initial assessment of the patient within forty-eight (48) hours of referral, the patient’s return home, or on a physician-ordered start of care date. Failure to conduct an initial assessment within the required timeframe has the potential to result in unmet patient needs and negative patient outcomes. Review of the agency’s policy entitled “OASIS Outcome and Information Set” last review date 06/26/2023 revealed the following: An initial assessment visit is to determine immediate care and support needs of the patient within forty-eight (48) hours of referral or within forty-eight (48) hours of patient’s return home or a physician-ordered SOC (start of care) date. Patient #7 – This 94-year-old patient with diagnoses that include polycythemia vera, pain in right hip, and constipation was admitted to the agency on 05/05/2023. Review of the physician’s office referral dated 04/13/2023 revealed the following: Reason for Referral: evaluate and treat wound care. Nurse Note: Acute visit. Pressure sore on right hip for a couple weeks. Subjective: Patient presents to discuss sore right hip. C/O (Complains of) sore right hip/buttocks region x (times) four (4) weeks. Our office sent referrals for wound care nurse to follow… Objective: Skin – one (1) cm (centimeter) superficial open area right lateral buttocks hip region. Assessment #1: Open wound of right hip region. The agency received the referral by Fax on 04/28/2023. Review of the Coordination Note dated 05/01/2023 revealed the Licensed Practical Nurse (LPN) documented the following: Primary Diagnosis/Reason for Home Health: Wound care pressure sore right hip, T9 complete fracture, and osteoporosis. Disciplines ordered: SN (Skilled Nurse). Review of the Coordination Note dated 05/02/2023 Patient Coordinator documented the following: Date of planned admission: Yes, 05/04/2023. The name of the admitting clinician (if known) and that the clinician will be calling them to schedule the visit: Yes, RN (Registered Nurse) Case Manager. Review of the clinical record from 04/28/2023 to 09/14/2023 lacked documented evidence that a SN went out to complete an initial assessment visit. During an interview on 09/25/2023 at 12:08 PM, the Clinical Manager (CM) stated that a Registered Nurse (RN) did go out to the patient’s home on 05/04/2023 and completed an assessment of the patient. The CM continued to state that upon the RN’s assessment of the patient there was no skilled need, and that the RN did not document this assessment in the clinical record and should have documented the assessment. The CM continued to state that the RN notified her of the visit and the that she should have documented the conversation, and that the patient did not have a skilled need at this time. During an interview on 09/25/2023 at 12:16 PM, the CM stated that there should be a note or an order to show the delayed start of care. As of exit, no further information was provided to refute the findings.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for three (3) of seventeen (17) patients (Patient #s: 13, 16, 17), the agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the Start of Care (SOC). The issues are: - Registered Dietician (RDT) failed to complete a comprehensive assessment within five (5) days of the SOC. - Occupation Therapy (OT) failed to complete a comprehensive assessment within five (5) days of the SOC. Failure to ensure a comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. Patient #13 - This 83-year-old patient with diagnoses that include third (oculomotor) nerve palsy, right eye, type 2 diabetes mellitus, and essential hypertension was admitted to the home care agency on 09/04/2023. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the order for an RDT evaluation. Review of the patient care record from 09/04/2023 to 09/20/2023 (timeframe provided to the surveyors) lacked documented evidence of an RDT evaluation. The RDT failed to complete a comprehensive assessment of the patient within five (5) calendar days after the start of care. During interview on 09/25/2023 at 10:59 AM, the Physical Therapist stated when she calls into the physician to get the verbal order at start of care, she states all disciplines needed. During interview on 09/25/2023 at 11:00 AM, the Clinical Manager stated that the referral was made during the care conference that occurred within 24-48 hours of the start of care. The Clinical Manager stated that dietary went to see the patient on 09/21/2023 at the request of the patient. The Clinical Manager stated she would send documentation of the visit and the patient’s request. As of exit, no further information was provided to refute the findings. Patient #16 – This 89-year-old patient with diagnoses that include metabolic encephalopathy, atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the home care agency on 08/23/2023. Review of the Home Health Certification and Plan of Care for certification period 08/23/2023 to 10/21/2023 revealed the order for an OT evaluation. Review of the Missed Visit Notification dated 08/25/2023 revealed the OT notified the physician of the need to reschedule the visit scheduled for 08/25/2023 to the next Medicare week. The Missed Visit Notification lacked a reason for the need to rescheduled visit planned for 08/25/2023. The OT failed to complete a comprehensive assessment of the patient within five (5) calendar days after the start of care. During interview on 09/26/2023 at 01:57 PM, the OT stated she can’t visualize who this patient is; but if she can recall, she had to reschedule to the following week, but she does not know why. Patient #17 - This 67-year-old patient with diagnoses that include malignant neoplasm of the hypopharynx, dysphagia, encounter for attention to gastrostomy, and hemiplegia following cerebral infarct affecting right dominant side was admitted to the home care agency on 08/22/2023. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the order for an RDT evaluation. Review of the RDT Add on Evaluation dated 09/07/2023 revealed the RDT evaluation was completed sixteen (16) days after the start of care. The RDT failed to complete a comprehensive assessment of the patient within five (5) calendar days after the start of care. During interview on 09/25/2023 at 03:30 PM, the Clinical Manager stated the Dietician works per diem. The Clinical Manager stated that the patient did not have the right equipment in the home and wanted the SLP to visit first to evaluate his swallowing and that the patient requested a delayed start because there were so many disciplines involved in his care. Additionally, the Clinical Manager stated that normally the agency would have notified the doctor regarding the need to push the initial visit out. Lastly, the Clinical Manager stated the doctor was notified of the delay but that the notification was not documented. During interview on 10/03/2023 at 01:42 PM, the Dietician 2 stated the first she heard of him was on 08/28/2023 when she received the email from the Clinical Manager.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on review of clinical records and staff interview for eight (8) of seventeen (17) patients (Patients #s: 5, 8, 10, 11, 13, 14, 16, and 17), the agency failed to ensure the comprehensive patient assessment accurately reflects the patient's status. Failure to ensure the comprehensive patient assessment is correct and accurately reflects the patient's status has the potential for unmet patient needs and can result in inadequate care. Patient #17 - This 67-year-old patient with diagnoses that include malignant neoplasm of the hypopharynx, dysphagia, encounter for attention to gastrostomy, and hemiplegia following cerebral infarct affecting right dominant side was admitted to the home care agency on 08/22/2023. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission note dated 08/22/2023 revealed there is no palliative care assessment documented for this patient to determine whether the patient had palliative care needs. During interview on 09/25/2023 at 03:30 PM, the Clinical Manager stated she would look for a late coordination note and would send it if it was available. As of exit, no further information was provided to refute the findings. Patient #14 - This 67-year-old patient with a diagnosis of dementia was admitted to the home care agency on 09/07/2023. Review of the PT (Physical Therapy) OASIS Admission note dated 09/07/2023 revealed there is no palliative care assessment documented for this patient to determine whether the patient had palliative care needs. During interview on 09/26/2023 at 12:15 PM, the PT 2 stated there is not a specific place to document the assessment of palliative care needs. The PT 2 stated he would have had a care journey conversation if the patient was appropriate. During interview on 09/26/2023 at 12:19 PM, the Area Vice President of Clinical stated there would have been a driveway call where they would have discussed if the patient was appropriate for palliative care. During interview on 09/26/2023 at 12:21 PM, the Clinical Manager stated the driveway calls are documented on a handwritten form and then put in as a care coordination note. The Clinical Manager stated that as of today, this documentation has yet to been done. Lastly, the Clinical Manager stated that agency policy allows the clinician seven days to complete their documentation, and because this timeframe has been exceeded the clinician would need to complete a late entry note. Patient #13 - This 83-year-old patient with diagnoses that include third (oculomotor) nerve palsy, right eye, type 2 diabetes mellitus, and essential hypertension was admitted to the home care agency on 09/04/2023. Review of the PT OASIS Admission note dated 09/04/2023 lacked documented evidence that the patient's immunization status was assessed. The PT failed to assess the patient's immunization status. During interview on 09/25/2023 at 10:55 AM, the Clinical Manager stated the vaccination assessment is not documented. Patient #16 – This 89-year-old patient with diagnoses that include metabolic encephalopathy, atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the home care agency on 08/23/2023. Review of the PT OASIS Admission note dated 08/23/2023 revealed there is no palliative care assessment documented for this patient to determine whether the patient had palliative care needs. During interview on 09/25/2023 at 09:45 AM, the Clinical Manager stated “I don’t know how to answer that.” Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. A.) Review of the RN OASIS Admission note dated 09/06/2022 revealed the Skilled Nurse (SN) documented the following under the head/neck assessment: -Indicate head and neck assessment findings: “Yes, abnormal findings in head and neck assessment.” -Indicate head and neck abnormalities: “other (specify)” -Indicate other head and neck abnormalities: “WNL” The Wound Assessment revealed the patient has radiation wounds on the right and left lower jaw, and the patient refused to allow the SN to assess the wounds. The narrative states that the patient has squamous cell carcinoma of the oral cavity, and the patient is being followed by an oncologist for care to the mouth wounds. The documentation is inconsistent. The patient has radiation wounds on the right and left lower jaw, and squamous cell carcinoma in the mouth. It is unclear why the clinician determined under the head and neck assessment that the abnormalities are within normal limits on an initial assessment of the patient, as these are abnormal findings at the initial assessment and the patient’s normal limitations have not been established. During interview on 09/26/2023 at 02:14 PM the Clinical Manager stated that the SN was no longer employed by the agency. The Clinical Manager stated that due to recent upgrades in the software system, the clinicians were instructed to answer yes to abnormalities in order to open the assessment so that it allows for further assessment of the area. She explained that it was the agency’s concern that it would not be enough if the clinician answers “no” in the assessment to indicate no problems were identified, then it wouldn’t allow for further assessment of the area. B.) Review of the RN OASIS Admission note dated 09/06/2022 revealed the Skilled Nurse (SN) documented the respiratory assessment as follows: -Indicate respiratory findings: “Yes, abnormal findings in respiratory assessment.” -Indicate abnormal respiratory assessment findings: “other (specify)” -Indicate other respiratory issue: “WNL” -When is the patient dyspneic or noticeably short of breath? “1-when walking more than 20 feet, climbing stairs.” The narrative states “Rt (right) upper lobe carcinoma…oxygen saturations of 99% on room air…lungs clear.” The documentation is inconsistent. It is unclear why the patient’s shortness of breath and history of lung carcinoma are documented as within normal limits on an initial assessment of the patient, as these are abnormal findings at the initial assessment and the patient’s normal limitations have not been established. During interview on 09/26/2023 at 02:14 PM the Clinical Manager stated that the SN was no longer employed by the agency. The Clinical Manager stated that due to recent upgrades in the software system, the clinicians were instructed to answer yes to abnormalities in order to open the assessment so that it allows for further assessment of the area. She explained that it was the agency’s concern that it would not be enough if the clinician answers “no” in the assessment to indicate no problems were identified, then it wouldn’t allow for further assessment of the area. C.) Review of the RN OASIS Admission note dated 09/06/2022 revealed the Skilled Nurse (SN) documented the nutritional assessment as follows: -Does the patient have food available in the home or the ability to obtain food” “Yes.” -Indicate the nutritional assessment findings: “No nutritional problems noted- 0 pts.” Under the assessment, the SN documented the following answer to the question: “Feeding or eating: current ability to feed self meals and snacks safely. Note: this refers only to the process of eating, chewing, and swallowing…unable to take nutrients orally and is fed nutrients through nasogastric tube or gastrostomy.” Additionally, the SN documented the patient is “able to take medications at the correct times if given reminders by another person at the appropriate times.” In the narrative, the SN documented the patient has basaloid squamous cell carcinoma of the oral cavity, and a Cancer Center is performing care to mouth wounds Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the patient has a gastrostomy tube for enteral feeding. Additionally, the patient’s medications are ordered to be administered by oral route. The assessment lacks documentation regarding the patient’s ability to swallow oral medications or whether administration of oral medications poses a safety hazard based on the patient’s history of oral carcinoma, mouth sores and need for enteral nutrition. During interview on 09/26/2023 at 02:30 PM the Clinical Manager stated that the SN was no longer employed by the agency. The Clinical Manager stated that she believed the patient was not taking anything by mouth and it was unknown how the patient was taking medications as it is not documented. The Clinical Manager stated that the SN should have changed the medications from oral route to be administered through the PEG tube. Additionally, the Clinical Manager stated that the patient had PEG tube for two years and was able to manage feeds and flushes independently. D.) Review of the RN OASIS Admission note dated 09/06/2022 revealed there is no palliative care assessment documented for this patient to determine whether the patient had palliative care needs. During interview on 09/26/2023 at 02:30 PM the Clinical Manager stated that the collaboration note, for the palliative care assessment, was not put in. Patient #8 – This 89-year-old patient with diagnoses that include other symptoms and signs with cognitive function following cerebral infarction, vascular dementia, and essential (primary) hypertension was admitted to the agency on 06/28/2023. Review of the PT OASIS Admission note dated 06/28/2023 revealed there is no palliative care assessment documented for this patient to determine whether the patient has palliative care needs. During an interview on 09/27/2023 at 02:15 PM, the Clinical Manager stated that the care journey note was not placed in the clinical record. HV Patient #10 – This 70-year-old patient with diagnoses that include pressure ulcer of right buttock, stage 4, morbid (severe) obesity with alveolar hypoventilation, and peripheral vascular disease was admitted to the agency on 08/09/2023. Review of the RN (Registered Nurse) OASIS Admission note dated 08/09/2023 revealed the RN documented the following: Mobility Roll left and right SOC (Start of Care)/ROC (Resumption of Care) Performance: The ability to roll from lying on back to left and right side and return to lying on back on the bed. Code the patient’s usual performance at SOC/ROC for each activity using the 6-point scale. If activity was not attempted at SOC/ROC, code the reason. Coding: safety and the quality of performance – if helper assistance is required because patient’s performance is unsafe or poor quality, score according to amount of assistance provided. 05. – Setup or clean-up assistance – helper sets up or cleans up; patient completes activity. Helper assists only prior to or following the activity. Mobility roll left and right discharge goal: the ability to roll from lying on back to left and right side and return to lying on back on bed. Code the patient’s usual performance at SOC/ROC for each activity using the 6-point scale. If activity was attempted at SOC/ROC, code the reason, coding: safety and quality of performance – if helper assistance is required because patient’s performance is unsafe or poor quality of care, score according to amount of assistance provided. 06. – Independent – Patient completes the activity by themselves with no assistance from a helper. Mobility sit to lying SOC/ROC performance: the ability to move from sitting on side of bed to lying flat on the bed, code the patient’s usual performance at SOC/ROC for each activity using the 6-point scale. If activity was not attempted at SOC/ROC, code the reason. Coding: safety and quality of performance – of helper assistance is required because of patient’s performance is unsafe or of poor quality, score according to amount of assistance provided. 05. – setup or clean-up assistance – helper sets up or cleans up; patient completes activity. Helper assists only prior to or following the activity. Mobility sit to lying discharge goal: the ability to move from sitting on side of bed to lying flat on the bed, code the patient’s discharge goal(s) using the 6-point scale, coding: safety and quality of performance – if helper assistance is required because the patient’s performance is unsafe or of poor quality, score according to amount of assistance provided. 06. Independent – Patient completes the activity by themselves with no assistance from a helper. Mobility lying to sitting on side of bed SOC/ROC performance: the ability to move from lying on the back to sitting on the side of the bed with no back support. Code the patient’s usual performance at SOC/ROC for each activity using the 6-point scale. If activity was not attempted at SOC/ROC, code the reason. Coding: safety and quality of performance – if helper assistance is required because the patient’s performance is unsafe or of poor quality, score according to amount of assistance provided. 05. – Setup or clean-up assistance – helper sets up or cleans up; patient completes activity. Helper assists only prior to or following the activity. Mobility lying to sitting on side of bed discharge goal: the ability to move from lying on the back to sitting on the side of the bed with no back support. Code the patient’s discharge goal(s) using the 6-point scale. Coding: safety and performance – if helper assistance is required because of the patient’s performance is unsafe or of poor quality, score according to amount if assistance provided. 06. – Independent – patient completes the activity by themself with on assistance from a helper. Narrative: I asked the patient if we could go in her bedroom so she can lay down; while I remove the dressing and take a look at the wound. Patient has no bed and sleeps in the recliner. During an observational home visit on 09/12/2023 at 10:00 AM, the surveyor observed the patient to not have a bed in her home. The agency failed to ensure the RN OASIS Admission (initial comprehensive assessment) accurately reflects the patient’s status at the time of the assessment. During an interview on 09/29/2023 at 03:29 PM, the RN stated that her train of thought there was that the recliner was her bed. During an interview on 09/29/2023 at 03:31 PM, the Area VP of Clinical stated that if the patient does not have a bed, then the questions should not have been answered and coded to reflect that the patient does not have a bed. Patient #11 – This 75-year-old patient with diagnoses that include Alzheimer’s disease, dementia in other diseases classified elsewhere, unspecified severity, with agitation, and iron deficiency anemia was admitted to the agency on 08/12/2023. Review of the PT OASIS Admission note dated 08/12/2023 revealed the PT documented the following: Gastrointestinal: Indicate Gastrointestinal Assessment Findings: No abnormal findings in Gastrointestinal Assessment. Indicate Date of Last Bowel Movement: 08/11/2023. Bowel Incontinence Frequency: 0 – Very rarely or never has bowel incontinence. Ostomy for Bowel Elimination: Does this patient have an ostomy for bowel elimination that (within the last 14 days): A) Was related to an inpatient facility stay: or B) Necessitated a change in medical or treatment regimen? 0- Patient does not have an ostomy for bowel elimination. There is a lack of documented evidence of the patient’s bowel frequency. During an interview on 09/29/2023 at 02:01 PM, the Clinical Manager (CM) stated that the clinician is not able to free text the patient’s bowel movement frequency and that the patient does not have any diagnosis that would flag the clinician to document the patient’s bowel movement frequency.

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 review of clinical records, agency policy and procedure, and interviews with agency staff, for four (4) of seventeen (17) patients (Patient #s: 5, 6, 12, and 13), the clinical record lacked documented evidence of a complete review of all medications the patient is currently using to ensure accuracy of the orders, identify any potential adverse effects, drug reactions or concerns. Failure to conduct a complete medication review has the potential for the patient to experience medication side effects or to receive incorrect medication dosages. Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. A.) Review of the RN OASIS Admission note dated 09/06/2022 revealed the Skilled Nurse (SN) documented the patient is unable to take in nutrients orally and is fed nutrients through nasogastric tube of gastrostomy, there were no issues identified during the drug regimen review, and the patient was able to take medication(s) at the correct times if given reminders by another person at the appropriate times. The narrative states that the patient has basaloid squamous cell carcinoma of the oral cavity, and a Cancer Center is performing care to mouth wounds. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the patient has a gastrostomy tube for enteral feeding. Additionally, the patient’s medications are ordered to be administered by oral route as follows: -Alendronate 70 mg tab, 1 tablet weekly oral every Monday for bone health -Cipro 500 mg tablet 2 tablets oral every Tuesday and Saturday for infection prevention -Famotidine 20 mg tablet oral daily for digestion -Loperamide 2 mg tablet 1 tablet daily/prn oral for bowel management -Loratadine 10 mg capsule, 1 capsule daily oral for allergy -Pentoxifylline ER (extended release) 400 mg tablet, 1 tablet 2 times daily oral for anti-inflammatory During interview on 09/26/2023 at 02:30 PM the Clinical Manager stated that the SN was no longer employed by the agency. The Clinical Manager stated that she believed the patient was not taking anything by mouth and it was unknown how the patient was taking medications as it is not documented. The Clinical Manager stated that the SN should have changed the medications from oral route to be administered through the PEG tube. B.) Review of the RN OASIS Admission note dated 09/06/2022 revealed the Skilled Nurse (SN) documented the patient has reported pain in the last 5 days, with a maximum amount of pain rating 4/10 (with 0 being no pain and 10 the wort pain the patient experienced). Additionally, the patient reports pain daily but not constantly, and the location of the pain is the left lower extremity with aching quality. Review of the pre-admission paperwork dated 09/01/2022 revealed the patient’s medication regimen included: Ibuprofen oral 200 mg tablet PRN (as needed). Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 lacked an order for pain medications. Review of the RN OASIS Admission note dated 09/06/2022 revealed the Skilled Nurse (SN) documented the patient has reported pain in the last 5 days, with a maximum amount of pain rating 4/10 (with 0 being no pain and 10 the worst pain the patient experienced). Additionally, the patient reports pain daily but not constantly, and the location of the pain is the left lower extremity with aching quality. During interview on 09/26/2023 at 02:26 PM the Clinical Manager stated that there is no order for pain medication on the plan of care, but the patient had an order for Ibuprofen because it is listed in the face-to-face pre-admission paperwork. The Clinical Manager stated that the SN should have added Ibuprofen to the plan of care. C.) Review of the SN Subsequent Visit dated 10/03/2022 revealed the patient’s pain was documented under vital signs as “2”. The pain assessment states that the patient reported pain within the last 5 days with the maximum amount of pain rating 4/10, daily but not constantly. The pain was described as generalized chronic aching pain that is relieved by distraction, positioning, rest/sleep. The SN documented under interventions provided that the SN instructed on appropriate pain management techniques to include “taking medications as prescribed while pain is still tolerable.” Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 lacked an order for pain medications. During interview on 09/26/2023 at 02:57 PM the Clinical Manager stated agreement that there was no order for pain medication, and that the SN should have brought the Ibuprofen order from the preadmission face-to-face paperwork over to the plan of care. Patient #12- This 80 year old patient with diagnoses that include Encounter for orthopedic aftercare following surgical amputation, Type II Diabetes, and personal history of diabetic foot ulcer was admitted to the agency on 06/25/2023. This patient resides in an Assisted Living facility. The agency failed to ensure there is a complete review of all medications to ensure all medications orders are accurate as evidenced by the following: Review of the Home Health Certification and Plan of Care (POC) for certification period 08/24/2023 to 10/22/2023 revealed the following orders: -Artificial Tears 1% eye drops, 1 drop as directed every 2 hours PRN (as needed) for dry eye. -Eliquis 5 mg tablet 2 tablets, two times daily, oral, for cardiac. -Gabapentin 300 mg capsule, 1 capsule 2 times daily, oral for neuropathy. Review of the Assisted Living Order Summary Report for active orders as of 09/14/2023 revealed the following orders: -Artificial Tears Ophthalmic Solution 1%, instill 2 drops in right eye every 04 hours as needed for dry eyes. The start date for this medication is 06/14/2023. The order is inconsistent with the POC. - Eliquis Oral Tablet 5 mg (Aplxaban) Give 1 tablet by mouth two times a day for blood thinner. The start date for this medication is 06/14/2023. The order is inconsistent with the POC. -Neurontin Oral Capsule 100 mg (Gabapentin) Give 1 capsule by mouth two times a day for neuropathy. This order is inconsistent with the POC. During interview on 09/15/2023 at 01:50 PM the Director of Operations (DOO) stated that the doses should be the same, but she would have to find out. The DOO stated that a medication reconciliation should be completed at every visit. The DOO added that the nurse should review the facility’s Medication Administration Record (MAR) and review it to determine if there are discrepancies between the MAR and the agency’s record. During interview on 09/27/2023 at 03:30 PM the Registered Nurse stated that it was her practice to ask the patient at every visit if there have been any medication changes. The RN stated that the patient is capable of answering the questions, is reliable and capable of answering questions about medications. Patient #6- This 64 year old patient with diagnoses that include Ataxia following cerebral infarction, chronic atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the agency on 06/09/2023. This patient is receiving therapy only services. The agency failed to ensure a comprehensive medication review was conducted as evidenced by the following: A.) Review of the SNF IDT Post Discharge Plan of Care dated 06/05/2023 revealed the patient was discharged from the Skilled Nursing Facility with an order for Metoprolol Succinate ER 100 mg extended release 24 hour, 1 tablet, by mouth in the morning. Review of the PT (Physical Therapist) OASIS Admission dated 06/09/2023 revealed the PT documented under Medication Understanding Changes the order for Metoprolol Succinate ER 100 mg tablet, extended release 24 hour. Review of the Home Health Certification and Plan of Care (POC) for certification period 08/08/2023 to 10/16/2023 revealed the order for Metoprolol Succinate ER, extended release 24 hour, 100 mg daily, instructions: 1.5 tablets daily. The ordered dosage is inconsistent with the information in the OASIS Admission note. During interview on 09/29/2023 at 01:17 PM the Area Vice President of Operations stated that the information should match. B.) Review of the agency policy entitled “Drug Regimen Review (Home Health Only), last revised 01/2020 revealed “The clinician completing the OASIS Assessment must complete a comprehensive drug regimen review of all medications the patient is currently taking at the time of admission, recertification, resumption of care and with any major change in condition…When patients are admitted to the Home Health Agency from acute or post-acute facilities, it is the responsibility of the admitting clinician to assure they review the discharge paperwork from the facility to assure all medications with correct dosages are captured.” Review of the Skilled Nursing Facility (SNF) Order Summary Report, Active Orders As of: 07/21/2023 revealed orders for the following medications: -Acetaminophen Suppository 650 mg, insert 1 suppository rectally every 4 hours as needed PRN for general discomfort of fever(as needed) -Tylenol 325 mg, 2 tablets, by mouth, every 4 hours PRN for general discomfort or temperature -Aspirin Tablet chewable 81 mg, give 1 tablet by mouth every day for prophylaxis -Bisacodyl Suppository, insert 1 suppository rectally daily PRN for bowel management -Clopidogrel Bisulfate oral tablet 75 mg, give 1 tablet by mouth one time a day for atrial fibrillation -Digoxin tablet 125 mcg, give 1 tablet by mouth one time a day for hypertension. Hold for pulse less than 60 or above 120 and call provider -Fleet enema 7-19 gm/118 ml, insert 1 applicatorful rectally as needed for bowel management PRN -Metformin HCL oral tablet 1000 mg, give 1 tablet by mouth a day for diabetes -Metoprolol Succinate ER Oral Tablet Extended release 24 hour 100 mg, give 1.5 tablets by mouth one time a day for hypertension. -Milk of Magnesia Suspension 400 mg/5ml, give 30 cc by mouth as needed for bowel management daily PRN -Mirtazapine Oral Tablet 15 mg, Give 1 tablet by mouth at bedtime for appetite -Polyethylene Glycol, Give 17 gm by mouth one time a day for bowel management- mix in 4-6 oz of beverage. -Senna S 8.6-50 mg, Give 1 tablet by mouth one time a day for bowel management. Review of the Home Health Certification and Plan of Care for certification period 08/08/2023 to 10/06/2023 revealed the following: -Losartin 100 mg tablet oral, 100 mg daily for cardiac. This medication is not on the SNF Order Summary Report. -Repatha Sureclick 140 mg/ml Subcutaneous Pen Injector, subcutaneous 140 mg every other week for HDL (high cholesterol). This medication is not on the SNF Order Summary Report. Additionally, the following medications are on the SNF Order Report, but are not documented in the POC: Acetaminophen Suppository 650 mg, insert 1 suppository rectally every 4 hours as needed PRN for general discomfort of fever(as needed) -Tylenol 325 mg, 2 tablets, by mouth, every 4 hours PRN for general discomfort or temperature -Aspirin Tablet chewable 81 mg, give 1 tablet by mouth every day for prophylaxis -Bisacodyl Suppository, insert 1 suppository rectally daily PRN for bowel management -Clopidogrel Bisulfate oral tablet 75 mg, give 1 tablet by mouth one time a day for atrial fibrillation -Digoxin tablet 125 mcg, give 1 tablet by mouth one time a day for hypertension. Hold for pulse less than 60 or above 120 and call provider -Fleet enema 7-19 gm/118 ml, insert 1 applicatorful rectally as needed for bowel management PRN -Milk of Magnesia Suspension 400 mg/5ml, give 30 cc by mouth as needed for bowel management daily PRN -Polyethylene Glycol, Give 17 gm by mouth one time a day for bowel management- mix in 4-6 oz of beverage. -Senna S, 8.6-50 mg, Give 1 tablet by mouth one time a day for bowel management. Review of the PT Resumption of Care dated 07/27/2023 revealed the PT documented there were no medication discrepancies, issues or non-compliance found. The visit was to resume care, “Aftercare CVA (cerebral vascular accident); recent hospitalization for UTI (urinary tract infection)/sepsis and another SAR (subacute rehabilitation) admission. During interview on 09/29/2023 at 01:46 PM the findings were presented. The Area Vice President of Operations stated that the Skilled Nursing Facility (SNF) Order Summary Report was the SNF inpatient list , and not a list of the medications the patient was discharged with. She stated that she did not think the SNF Order Summary was a discharge summary. The Area Vice President stated that the clinician should be documenting what was reviewed when the medication reconciliation is completed. C.) Review of the PT/PTA Subsequent Visit dated 08/02/2023 revealed the PT documented “Medication discrepancies…Other Medication Discrepancies Found…DC Repatha injections noted in MD documentation.” Under Care Coordination the PT documented that the PT communicated with the Occupational Therapist regarding “status, recert.” There is no documentation that a Registered Nurse was notified about the medication discrepancy , and no documentation that the physician was contacted to verify orders. Review of the Physician Orders dated 07/27/2023 revealed the order for Repatha Sureclick Pen Injector 140 mg/ml, 140 mg every other week subcutaneous, for HDL (high density Lipoprotein). During interview on 09/25/2023 at 09:15 AM the PT stated that the order to discontinue Repatha came from the patient’s sister, who is also the patient’s primary caregiver. The PT stated that the patient’s sister had the patient’s medication chart from the physician on her phone, and the medication was to be discontinued at that time. The PT stated that she did not verify the order with the physician, she just visualized the information from the patient’s sister’s phone. Patient #13 - This 83-year-old patient with diagnoses that include third (oculomotor) nerve palsy, right eye, type 2 diabetes mellitus, and essential hypertension was admitted to the home care agency on 09/04/2023. The agency failed to ensure a comprehensive medication review was conducted as evidenced by the following: Review of the agency’s policy entitled “Drug Regimen Review (Home Health Only)” last revised 01/2020 revealed the following: “Procedure: 1. The clinician completing the OASIS Assessment must complete a comprehensive drug regimen review of all medications the patient is currently taking at the time of admission…When patients are admitted from acute or post-acute facilities, it is the responsibility of the admitting clinician to assure they review the discharge paperwork from the facility to assure all medications with correct dosages are captured… New York: Therapists conducting the OASIS assessment(s), for which medication profile is required, will list all the patient’s current prescribed and over the counter medications, dose, frequency, and route…and report this information back to the designated drug reviewer, Clinical Manager, at the agency…The designated drug regimen reviewer must document the review including date and signature in the clinical record…” A. Review of the Face-to-Face Encounter dated 08/31/2023 revealed orders for the following medications: - Furosemide 20mg, 1 tablet, by mouth, every day - Basaglar Kwikpen 100 unit/ml, inject 45 units daily at bedtime - Carvedilol Phosphate ER 40 mg, 1 tablet, by mouth, every day - Trulicity 0.75mg/0.5ml, administer 0.75mg under the skin, every week - Atorvastatin 80 mg, 1 tablet by mouth, every day; - Diclofenac Sodium 1%, use 2 g (grams) to affected area, max 4 times per day - Tylenol Extra Strength 500 mg, 1 by mouth, three times a day for severe pain - Ferrous Sulfate 325 mg, 1 tablet by mouth, every day - Vitamin D-3 1.25 mg, 1 by mouth, 1 time per week - Metformin HCL 1000 mg, 1 tablet by mouth, 2 times per day - Vitamin C 500 mg, 1 tablet by mouth, every day - Meclizine HCL 12.5 mg, 1 tablet by mouth, every day as needed (PRN) - Aspirin 81 mg, take 2 tablets by mouth, every day - Oxybutynin Chloride ER 5 mg, take 1 tablet by mouth, every day - Januvia 100 mg, 1 tablet by mouth, every day - Aspirin 81 mg, chew and swallow 1 tablet by mouth, once daily Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the following: - Acetaminophen 325 mg, 2 tablets by mouth, every six hours/PRN for pain. This medication dose and strength is different than what is on the Face-to-Face Encounter. - Amlodipine 5 mg, 1 tablet by mouth, daily for blood pressure. This medication is not on the Face-to-Face Encounter. - Aspirin 81 mg, delayed release, 1 tablet by mouth daily for prophylactic. This medication dose and strength is different than what is on the Face-to-Face Encounter. - Atorvastatin 80 mg, 1 tablet by mouth, every day for hyperlipidemia - Coreg 12.5 mg, 1 tablet, by mouth, every 12 hours for hypertension. This medication dose and frequency is different than what is on the Face-to-Face Encounter. - Ferrous Sulfate 325 mg, 1 tablet by mouth, every day for supplementation. - Furosemide 20mg, 1 tablet, by mouth, every day for edema. - Humalog U – 100 Insulin 100 unit/ml (milliliter) subcutaneous, use sliding scale, before meals and at bedtime for diabetes mellitus. Sliding scale: 170 – 209 (1 unit), 210 – 249 (2 units), 250 – 289 (3 units), 290 – 329 (4 units), 330 – 369 (5 units), 370 – 400 (6 units), call MD if BG is less than 60 or greater than 400. This medication is not on the Face-to-Face Encounter. - Januvia 100 mg, 1 tablet by mouth, every day for diabetes mellitus. - Lantus U-100 Insulin 100 unit/ml subcutaneous, 15 units at bedtime for diabetes mellitus. This medication is not on the Face-to-Face Encounter. - Metformin 1,000mg, by mouth two times per day for diabetes mellitus. - Oxybutynin Chloride 5 mg, take 1 tablet by mouth, every day for bladder. - Plavix 75 mg, take 1 tablet by mouth, daily for clot prevention. This medication is not on the Face-to-Face Encounter. - Trulicity 0.75mg/0.5ml subcutaneous, give one injection weekly on Sundays. Review of the PT (Physical Therapy) OASIS Admission dated 09/04/2023 revealed the PT documented the following: no medication discrepancies, issues, or noncompliance found, medications reviewed, all medications in home and accurate compared to sub-acute discharge list except needs to order Trulicity pen for weekly injection, Humalog and Lantus listed but states “has never been used before in home”, and doctor’s office to be notified next business day due to holiday. Review of the RN (Registered Nurse) Add-On Evaluation dated 09/08/2023 revealed the RN documented medication discrepancies identified and amlodipine missing from medications at home. During interview on 10/03/2023 at 09:27 AM the findings were presented. The Clinical Manager stated she is not sure what the PT reconciled the medications to. During interview on 09/25/2023 at 11:15 AM, the PT stated that from what she can recall the Lantus and Humalog were from rehab and were ordered by the discharging facility. The PT stated she did communicate with the patient’s doctor’s office, but they would not own it until seeing the discharge instructions from rehab. During interview on 09/28/2023 at 09:22 AM, the RN Case Manager stated she can’t answer whether the patient ever received the missing amlodipine because she does not recall. The RN Case Manager stated that she does not see any documentation in the patient record regarding whether the amlodipine was ever obtained. Lastly, the RN Case Manager stated that typically she would have looked through the patient’s medications, notified the doctor if it was missing, and checked with the pharmacy to see if it was ever picked up. B. Review of the Client Medication Report printed on 09/13/2023 lacked documented evidence of a review date and who it was reviewed by. During interview on 09/28/2023 at 10:53 Am, the Clinical Manager stated she reviewed the medication report, but she does not know why it is not dated or signed. The Clinical Manager stated that because the coding has not been done, and the 485 is not complete, that may be the reason for why the medication report is not signed or dated. Review of the agency’s policy entitled “Drug Regimen Review (Home Health Only) date revised 01/2020 revealed the following: 1. The clinician completing the OASIS Assessment must complete a comprehensive drug regimen review of all medications the patient is currently taking at the time of admission, recertification, resumption of care and with any major change in condition. The medication profile is completed by documenting - All the patient’s medications which includes: - Medications on written prescriptions and mediation bottles; - Over the counter medications. - Herbal products. - Vitamins and Supplements and - Oxygen. When patients are admitted to the Home Health Agency from acute or post-acute – facilities, it is the responsibility of the admitting clinician to assure they review he discharge paperwork from the facility to assure all medications with correct dosages are captured. Review and identify: - Potential adverse effects. - Ineffective drug therapy. - Drug reactions. - Significant side effects. - Significant drug interactions. - Duplicate drug therapy (Such as Lasix and Furosemide/Coumadin and Warfarin) and - Noncompliance with drug therapy. If a therapist identifies mediation discrepancies, the therapist should notify the RN – Clinical Manager or the RN – Director of Operations. If any problem/concerns are noted, the RN – Clinical Manager or the RN – Director of Operations must contact the Physician to verify, receive/write subsequent orders and amend the medication profile as indicated. Patient #11 – This 75-year-old patient with diagnoses that include Alzheimer’s disease, dementia in other diseases classified elsewhere, unspecified severity, with agitation, and iron deficiency anemia was admitted to the agency on 08/12/2023. Review of the Continuity of Care Document dated 08/11/2023 revealed the patient was taking the following medications: Quetiapine Fumarate 25 mg (milligram) tablets take one tablet by mouth twice a day. Tamsulosin HCL 0.4 mg capsules 1 (one) my mouth twice a day. Vitamin D 1000-unit tablets once per day. Atorvastatin Calcium 40 mg tablets take one tablet by mouth once daily. Ferrous Sulfate 325 (65Fe) mg tablets take one tablet my mouth twice a day. Pantoprazole Sodium 40 mg tablets DR (delayed release) take one tablet my mouth twice a day. Escitalopram Oxalate 10 mg tablets 1 (one) by mouth every day in the morning. Donepezil HCL 10 mg tablets 1 by mouth every day at night. Memantine 10 mg 2 (two) daily. Review of the Home Health Certification and Plan of Care for certification period 08/12/2023 to 10/10/2023 revealed orders for the following medications: Atorvastatin 40 mg tablet 1 tablet orally daily for cholesterol. Donepezil 10 mg tablet 1 tablet orally at bedtime for Alzheimer’s Disease. Ferrous Sulfate 325 mg (65 mg iron) tablet 1 tablet orally 2 times daily supplement. Memantine 10 mg tablet 1 tablet orally 2 times daily for dementia. Pantoprazole 40 mg tablet, delayed release 1 tablet orally 2 times daily for acid reflux. Quetiapine 25 mg tablet 1 tablet orally 2 times daily for mood. There is a lack of documented evidence that the patient is to be taking Vitamin D 1000-unit tablets once per day. During an interview on 09/29/2023 at 12:32 PM, the Clinical Manager stated vitamin D is not on the plan of care and that the clinician should have added the Vitamin D to the plan of care.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on clinical record review and staff interview for one (1) of seventeen (17) patients (Patient #1), requiring updates to the comprehensive assessment based on changes in the patient's health status, the agency failed to ensure the assessments were of sufficient scope to identify patient needs. Failure to ensure comprehensive assessments contain complete and accurate information has the potential for unmet patient needs. The agency failed to ensure assessments were of sufficient scope to identify patient needs as evidenced by the following: Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. A.) The patient was initially admitted to agency services for Physical Therapy (PT) only services on 11/12/2022 for deconditioning after a COVID-19 infection. On 12/23/2022 the PT contacted the patient’s granddaughter via phone about the PT’s inability to visit the patient because of a winter storm that affected roadway passage, the patient’s granddaughter informed the PT that there was no heat or power at the home. On 01/03/2023 the PT documented that the patient had wounds on the left great toe and the right great toe, and a nursing evaluation was requested. On 01/04/2023 the patient was brought to the Emergency Room for evaluation of the left and right great toes. Upon that visit, the patient was diagnosed with frostbite of the toes and was discharged home the same date. 01/05/2023, Skilled Nursing (SN) services were initiated for wound care to the left great and right great toes. Review of the PT OASIS Admission revealed the PT documented the patient’s height of 64 inches, weight of 112 lbs, and Body Mass Index (BMI) of 19. Under the nutritional assessment, the PT documented that the patient’s total nutritional assessment score is 1, and the risk level is “Good-reference: as appropriate reassess. Review of the Home Health Certification and Plan of Care for certification period 11/01/2022 to 01/10/2022 revealed the patient’s diet is regular. Review of the Add-ON Discipline Physician Order dated 01/05/2023 the order requires the Skilled Nurse (SN) to assess/ evaluate co-morbid conditions and any new conditions that present themselves during the episode to identify changes and intervene to minimize complications. Additionally, the SN is to observe/assess for nutrition management. Review of the RN (Registered Nurse) Add-on Evaluation dated 01/05/2023 revealed the patient has two wounds: wound #1, left great toe, frostbite and wound #2 right great toe, frostbite. Additionally, the patient has a cognitive impairment, impaired functional mobility, pain, and relies on others for activities of daily living. The RN documented under the nutritional assessment that the patient has food available, takes 3 or more prescribed or over the counter drugs per day, patient is not always physically able to shop, cook and/or feed self, the total nutritional risk score is 3, and the risk level is “moderate- reference: educate, refer and reassess based on patient situation.” Under interventions not provided, the RN documented that the patient was not instructed on nutritional/hydration requirements as diet prescribed by physician. The intervention was not provided because “additional time required to meet interventions.” No weight is documented. Review of the RN Recert Add-on Evaluation dated 01/09/2023 revealed the RN documented under the nutritional assessment that the patient has food in the home, takes 3 or more prescribed or over the counter drugs per day, without wanting to, the patient has lost or gained over 10 pounds in the past 6 months, patient not always physically able to shop, cook and/or feed self. The total nutrition score is 5 (previous score on 01/05/2023 is 3), and the patient’s nutritional risk level is “moderate-reference: educate, refer, and reassess based on patient situation.” Under the narrative, the RN documented that the patient’s appetite is “fair” per the patient’s granddaughter. Under interventions, the RN documented that the RN “instructed on appropriate food choices for prescribed diet (regular), adequate protein, and provided rationale for wound healing.” No weight is documented. It is unknown whether the patient has lost weight since admission to the agency, is maintain weight, or is gaining weight, and whether a referral for nutritional services is needed. The assessment is incomplete. During interview on 09/28/2023 at 10:06 AM the RN stated that she did not recall whether a weight was obtained during either the 01/05/2023 or 01/09/2023 assessments. The RN stated that looking at the patient’s nutritional risk score range of 3 to 5, the RN thought that a referral for nutritional services was not necessary. The RN stated that the patient had family with her at all times preparing her food. She stated that she believed the patient’s nutritional risk scores were in the same range, and the change was not significant enough to notify the physician. During interview on 09/28/2023 at 10:11 AM the Clinical Manager stated that there were no physician orders for a weight to be obtained for malnutrition. B.) Review of the PT OASIS Admission dated 11/12/2022 revealed the PT documented under Cognitive/behavioral that the patient is constantly confused, has a memory deficit: failure to recognize familiar persons/places, inability to recall events of past 24 hours, significant memory loss so that supervision is required. The patient lives with her granddaughter, who is the primary caregiver. Review of the SN Subsequent Visits from 01/20/2023 to 02/09/2023 revealed the patient’s pain was assessed using the PainAd Score scale (PAINAD is a scale that measures pain behavior in older adults who have dementia or other cognitive impairment and are unable to communicate their pain). The patient’s pain rated between 0 and 6 during that period. Review of the PT/PTA Subsequent Visit dated 01/30/2023, 02/02/2023 and 02/06/2023 revealed the PT documented “no” to the question, “does the patient report pain within the last 5 days?” It is unclear why the PT would ask the patient about a 5-day pain history if the patient was unable to recall events of the past 24 hours. During interview on 09/26/2023 at 10:50 AM the PT stated that he always conducts the pain assessment at the beginning of the visits and asked the patient about pain. The PT would then readdress the pain later in the visit. The PT stated that there were cognitive challenges with the patient and was not always freely compliant, but a caregiver was always present during visits. When asked if the PT obtained a pain history from the caregivers, the PT stated that he could not recall specifically, and that he was not sure what the pain was, and the caregiver did not bring it up. The PT stated that he did not believe pain was a limiting factor in the patient’s therapy. When asked whether the PT coordinated care with the RN or reviewed previous visit notes to determine what is going on with the patient, the PT stated that he did not, but he did not think pain was an issue.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff for one (1) of five (5) patients (Patient #2) requiring a recertification assessment, the agency failed to ensure a comprehensive assessment was completed within the last five (5) days of the sixty (60) day certification period. Failure to update the comprehensive assessment in a timely manner has the potential for unmet patient needs. Patient #2 - This 79-year-old patient with diagnoses that include venous insufficiency, non-pressure chronic ulcer of the right lower leg, chronic pain, and type 2 diabetes was admitted to the home care agency on 06/22/2018. This record was chosen as a potentially avoidable event: Substantial Decline in Management of Oral Medications. Review of the Home Health Certification revealed the current certification period is 09/29/2020 through 11/27/2022. Review of the patient care record revealed the Registered Nurse (RN) completed a visit on 11/22/2022 and the Licensed Practical Nurse (LPN) completed a visit on 11/25/2022. Review of the Client Coordination Note Report – Note Type: Late Visit Documentation dated 11/28/2022 (one day after the certification period ended) revealed the RN documented the patient orders expired, recertification was not completed, and the patient is to be readmitted under a new start of care. The agency failed to ensure a comprehensive assessment was completed within the last five days of the sixty-day certification period. During interview on 10/04/2023 at 11:15 AM, the Area Vice President of Operations stated we missed the recertification window because of a scheduling error. The Area Vice President of Operations stated the recertification should have been done at the 11/25/2022 visit, but because an LPN did that visit, the RN would have to discharge the patient and redo the start of care.

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 clinical record review and staff interview in one (1) of seventeen (17) records (Patient #5) the agency failed to provide services in accordance with an establish a Plan of Care (POC) that addresses patient needs, includes patient specific measurable outcomes and goals, and is updated as patient needs change. Failure to ensure care is provided in accordance with an individualized POC, has the potential for unmet patient needs and possible negative patient outcomes. Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. The agency failed to provide services in accordance with an establish a Plan of Care (POC) that addresses patient needs, includes patient specific measurable outcomes and goals, and is updated as patient needs change as evidenced by the following: A.) Review of the RN (Registered Nurse) OASIS Admission dated 09/06/2022 revealed the Skilled Nurse (SN) documented under the cardiovascular assessment that the patient had bilateral lower extremity edema. The right lower extremity edema is characterized as 1+ pitting edema, and the left lower extremity is characterized as 2+ pitting. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the POC does not include interventions, goals, or measurable outcomes to address the edema identified in the initial assessment of this patient who was admitted with an unstageable pressure ulcer of the left heel. During interview on 09/26/2023 at 02:50 PM the Clinical Manager stated that the SN did not write any interventions or goals for the edema. B.) Review of the RN Subsequent Visits dated 09/12/2022, 09/21/2022 and 10/03/2022 revealed the following: -On 09/12/2022 and 09/21/2022 the SN documented under the cardiovascular assessment that the patient had bilateral lower extremity edema. The right lower extremity edema is characterized as 1+ pitting edema, and the left lower extremity is characterized as 2+ pitting. There is no documentation that the RN coordinated with the patient’s authorized practitioner to review and update the POC and establish patient specific measurable outcomes and goals to address the edema. On 10/03/2022 the SN documented under the cardiovascular assessment that the patient had bilateral lower extremity edema. The right lower extremity edema is characterized as 1+ pitting edema, and the left lower extremity is characterized as 1+ pitting. There is no documentation that the RN coordinated with the patient’s authorized practitioner to review and update the POC and establish patient specific measurable outcomes and goals to address the edema. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed an order for the SN to assess, evaluate and develop an individualized plan of care. The POC does not include interventions, goals, or measurable outcomes to address the edema. During interview on 09/26/2023 at 02:50 PM the Clinical Manager stated that the SN did not write any interventions or goals for the edema.

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 review of clinical records, agency policy and procedure, and interviews with agency staff for ten (10) of seventeen (17) patients (Patient #s: 1, 5, 6, 9, 10, 11, 13, 15, 16, and 17), the agency failed to ensure a comprehensive Plan of Care (POC) was developed, based on interdisciplinary assessments, to meet the individualized needs of the patients. Failure to develop a complete and accurate POC that is comprehensive and addresses the patient needs has the potential to result in patient harm. The agency failed to ensure a comprehensive, individualized POC was developed as evidenced by the following: Patient #17 - This 67-year-old patient with diagnoses that include malignant neoplasm of the hypopharynx, dysphagia, encounter for attention to gastrostomy, and hemiplegia following cerebral infarct affecting right dominant side was admitted to the home care agency on 08/22/2023. A. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the following order: for SN three (3) times a week for one (1) week, one (1) time a week for four (4) weeks, and one (1) time every other week for four (4) weeks. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the following order: Enteral feeding/care and teaching - SN to perform and instruct in management of gastrostomy tube in left lower quadrant including care of site, equipment and preparation/administration of feedings. Type: Jevity 1.5 via bolus, six (6) cans daily, flush gastrostomy tube with 60 cc (cubic centimeters) of water before and after feeds, and additional 350 mls (milliliters) per day. Site care. Check tube placement, check residual with every feed. The order lacks direction for the following: the type and frequency of site care and who prepares, administers, checks for placement, and checks for residuals prior to each feed in the absence of the SN. The POC lacks a complete order for enteral feeds and feeding tube care to include the type and frequency of site care, who is responsible for site care in the absence of the SN, who is responsible for preparation, administration, and verification of tube placement in the absence of the SN, and who checks for residuals prior to each feed in the absence of the SN. During interview on 09/25/2023 at 03:40 PM, the Clinical Manager stated she should have put a note in stating that the patient was independent with g-tube (a tube inserted through the belly that brings nutrition directly to the stomach) management and feeds. Additionally, the Clinical Manager stated that the patient can check for residuals, but it is difficult for him to do. Lastly, the Clinical Manager stated there was no specific site care given by the provider specified on the 485. B. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission dated 08/22/2023 revealed that the RN documented: “G-Tube/PEG Tube, 18 French.” The POC lacks an order for durable medical equipment (DME) to include PEG tube, 18 French. During interview on 09/27/2023 at 03:50 PM, the Clinical Manager stated at the opening the patient did not have tubing or a pump and that he was currently using the syringe method to deliver his feeds. The Clinical Manager stated syringes and PEG tube supplies are not listed under DME. C. Review of the Referral dated 08/21/2023 revealed the patient was discharged to home requiring enteral feeds and a thickened liquid diet Review of the RN OASIS Admission dated 08/22/2023 revealed that the RN documented: “Nutritional Approaches; Check all of the nutritional approaches that apply on admission. B. Feeding tube and C. Mechanically altered diet – require change in texture of food or liquids.” Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the following order: Nutritional Requirements: six (6) cans Jevity 1.5 bolus daily, tube feedings. The POC lacks a complete diet order to include thickened liquids. During interview on 09/27/2023 at 03:45 PM, the Clinical Manager stated there was no specific diet order at opening because the ordering physician would not provide one until they received the orders from the referring facility. D. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the following order: Registered Dietician to evaluate for decreased intake. The order lacked a frequency for how often the Registered Dietician should visit the patient. During interview in 09/25/203 at 03:30 PM, the Clinical Manager stated the dietician frequency is not on the 485, it should be, and she does not know why it is not. Patient #13 - This 83-year-old patient with diagnoses that include third (oculomotor) nerve palsy, right eye, type 2 diabetes mellitus, and essential hypertension was admitted to the home care agency on 09/04/2023. Review of the agency policy entitled “Physician Orders and Medical Supervision of the Plan of Care” last reviewed 06/22/2023 revealed the following: “(b) A plan of care shall be developed within 10 days of admission to the agency and approved by the patient based on the comprehensive interdisciplinary patient assessment… (c) The plan of care shall cover pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, need for palliative care, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, instructions for timely discharge or referral, and any other appropriate items… (d) Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency and duration of such services…” A. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the following order: Registered Dietician to evaluate for proper diet guidelines. The order lacked a frequency for how often the Registered Dietician should visit the patient. During interview on 09/25/2023 at 10:35 AM, the Clinical Manager stated the frequency should be there, she is not sure why the frequency did not come over onto the plan of care, and this is not a complete plan of care because it is still in coding. B. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the following: - Type 2 diabetes - Physical Therapist (PT) for diabetes management. - Patient/caregiver to perform finger sticks three (3) times per day and report if blood glucose is less than 60 and greater than 400. -Skilled Nurse (SN) for instructions of diabetic care to include diet – no concentrated sweets, signs and symptoms of hypo/hyperglycemia, proper administration of diabetic medication, blood glucose testing per MD (medical doctor) orders, assess patient/caregiver ability to perform and record blood glucose testing as ordered and report abnormal findings to physician, perform blood glucose test as needed, and report to physician blood glucose readings “greater than 70 or less than 350.” - The patient's diabetic medications include: Humalog U – 100 Insulin 100 unit/ml (milliliter) subcutaneous, use sliding scale, before meals and at bedtime. Sliding scale: 170 – 209 (1 unit), 210 – 249 (2 units), 250 – 289 (3 units), 290 – 329 (4 units), 330 – 369 (5 units), 370 – 400 (6 units), call MD if BG is less than 60 or greater than 400; Januvia 100mg (milligram) tablet by mouth daily; Lantus U-100 Insulin 100 unit/ml subcutaneous, 15 units at bedtime; Metformin 1,000mg tablet, by mouth two times per day; and Trulicity 0.75mg/0.5ml subcutaneous, give one injection weekly on Sundays. Review of the Physician Orders from 09/04/2023 to 11/02/2023 revealed there was no order for blood glucose testing supplies to include lancets, strips, and a glucometer. The POC lacks orders for blood glucose testing supplies. During interview on 09/25/2023 at 10:45 AM, the Clinical Manager stated the diabetic supplies should be on the plan of care under supplies and they are not. C. Review of the Occupation Therapy (OT) Add On Discipline orders dated 09/06/2023 revealed the following order: OT will report blood sugar outside of parameters to the primary MD. The order lacked a blood glucose testing frequency and blood glucose parameters. During interview on 09/27/2023 at 01:55 PM, the Clinical Manger stated she believes the OT was referencing the parameters stated in the PT orders. D. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the patient takes 75 mg of Plavix by mouth daily for clot prevention. The POC lacked bleeding precautions for patients receiving anticoagulation therapy. During interview on 09/25/2023 at 10:46 AM, the Clinical Manager stated that the agency does not expect their clinicians to list bleeding precautions on the plan of care under safety measures if the anticoagulant pathway is selected. E. Review of the Face-to-Face Encounter dated 08/31/2023 revealed the patient has the following medical diagnoses: cerebral vascular attack (CVA), hypertension, type 2 diabetes, partial oculomotor nerve palsy, occlusion and stenosis of right posterior cerebral artery, congestive heart failure, and physical deconditioning. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 lacked documented evidence of the following diagnoses: CVA, occlusion and stenosis of right posterior cerebral artery, congestive heart failure, and physical deconditioning. The POC lacked documentation of all pertinent diagnoses. During interview on 09/25/2023 at 10:45 AM, the Clinical Manager stated the plan of care has not been completed by coding, so all diagnoses are not on the plan of care. F. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed an order for Oxybutynin Chloride 5mg tablet, by mouth, daily for bladder. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 lacked a medical diagnosis to correlate with Oxybutynin Chloride. The POC lacked documentation of all pertinent diagnoses. During interview on 09/25/2023 at 10:43 AM, the PT stated she doesn’t know why the patient is taking this medication and she cannot find a specific diagnosis for it, but it is listed as a medication the patient takes on the 485. During interview on 09/25/2023 at 10:45 AM, the Clinical Manager stated the plan of care has not been completed by coding, so all diagnoses are not on the plan of care. Patient #15 - This 83-year-old patient with diagnoses that include hypertensive heart disease with heart failure, chronic obstructive pulmonary disease, and atrial fibrillation was admitted to the home care agency on 08/24/2023. Review of the Home Health Certification and Plan of Care for certification period 08/24/2023 to 10/22/2023 revealed the Physical Therapist (PT) is to assess and record patient weight and notify CM (Clinical Manager) or RN (Registered Nurse) Case Manager for MD (Medical Doctor) notification for signs and symptoms of exacerbation (2 lb. (pound) weight gain in one (1) day, 5 lbs. in a week or 5 lbs. over baseline). The POC lacks a complete weight order to include how frequently it should be obtained. During interview the on 09/26/2023 at 11:20 AM, the PT stated the patient is to weight himself daily and the value should be documented under the vital signs. Additionally, the PT stated that if the patient was unstable the weight would be done more frequently than daily. During interview on 09/26/2023 at 1123 AM, the Area Vice President of Clinical stated there are pathways clinicians can choose based on diagnosis and the weight should have a specific frequency for how often it should be obtained. Patient #16 – This 89-year-old patient with diagnoses that include metabolic encephalopathy, atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the home care agency on 08/23/2023. A. Review of the Home Health Certification and Plan of Care for certification period 08/23/2023 to 10/21/2023 revealed the patient takes 5 mg of Eliquis by mouth two times daily for atrial fibrillation. The POC lacked bleeding precautions for patients receiving anticoagulation therapy. During interview on 09/25/2023 at 09:45 AM, the Clinical Manager stated that listing bleeding precautions as a safety measure is not an expectation, having the pathway is. B. Review of the Home Health Certification and Plan of Care for certification period 08/23/2023 to 10/21/2023 revealed an order for Nystatin 100,000 unit/gram topical daily for fungal infection. The order is incomplete and does not specify the site where the medication should be applied. During interview on 10/03/2023 10:00 AM, the Area Vice President of Operations stated that the order only says fungal infection and it lacks an area for application. C. Review of the Home Health Certification and Plan of Care for certification period 08/23/2023 to 10/21/2023 revealed an order for Nystatin 100,000 unit/gram topical daily for fungal infection. Review of the Home Health Certification and Plan of Care for certification period 08/23/2023 to 10/21/2023 lacked a medical diagnosis to correlate with Nystatin. During interview on 10/03/2023 10:03 AM, the Area Vice President of Operations stated that fungal infection is not listed as a diagnosis. The Area Vice President of Operations stated she sees an order on the referral for Nystatin powder, apply under breast, from back in July, but that later in July there is a note from a Nurse Practitioner that states no new rashes, so she is not sure if this issue had been resolved. The agency failed to ensure a comprehensive, individualized POC was developed as evidenced by the following: Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the order for the “Skilled Nurse (SN) to perform/teach patient/caregiver wound care pressure injury to unstageable L (left) heel: Cleanse wound with wound cleanser and gauze wrap with 4 layer wrap…secure with tape change dressing 2X per week and PRN (as needed) for soiled/dislodged…” Review of the RN (Registered Nurse) OASIS Admission dated 09/06/2022 revealed the RN documented that wound care was provided as ordered. There is no documented evidence that the patient/caregiver was educated or taught how to treat the left heel wound per the POC. During interview on 09/26/2023 at 02:40 PM the Clinical Manager stated that a 4-layer wrap should only be performed by a Skilled Nurse, and that the POC should not have included an order to teach the patient/caregiver how to apply a 4-layer wrap. Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. Review of the Home Health Certification and Plan of Care for certification period 01/11/2023 to 03/11/2023 revealed the Skilled Nurse is to “cleanse wound R (right) great toe with wound cleanser, apply Silvadene to toe, cover with gauze, secure with tape, 3 x weekly and PRN (as needed) dressing dislodgement…Skilled Nurse to cleanse L (left) great toe with wound cleanser, apply Silvadene to toe, cover with gauze, secure with tape 3 x weekly and PRN dressing dislodgement. Caregiver will perform wound care when SN not present.” Review of the Physician Order dated 01/20/2023 at 08:53 AM revealed orders for the following: -SN to cleanse the wound R great toe with wound cleanser, apply Medihoney to wound cover with dry gauze dressing, secure with tape… -SN to cleanse the wound L great toe with wound cleanser, apply Medihoney to wound cover with dry gauze dressing, secure with tape… Review of the Physicians Orders from 01/20/2023 to 03/11/2023 lack an order to discontinue the Silvadine. During interview on 09/28/2023 at 10:30 AM the Clinical Manager stated that there is no documentation to show that the Silvadene was discontinued. There is just an understanding to use the Medihoney. Patient #6- This 64 year old patient with diagnoses that include Ataxia following cerebral infarction, chronic atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the agency on 06/09/2023. This patient is receiving therapy only services. Review of the Home Health Certification and Plan of Care for certification period 08/08/2023 to 10/06/2023 revealed “Safety Measures: Fall precautions” for this patient with a history of falls. Review of the Aide Care Plan Report for 08/2023 to 10/06/2023 revealed under directions, there is nothing documented. Under transfers, the following is documented “Note PT (Physical Therapy) transfers with 1 assist using gait belt.” Under Activity, the Aide Care directs the following: Assist patient with ambulation, assist with transfer to chair, ambulate with walker, ambulate with stand by assistance. The Aide Care Plan does not have documentation that would alert the aide to use fall precautions in this patient who has a history of falls. On 09/29/2023 at 01:55 PM the Area Vice President of Clinical stated that she did not see fall precautions in the Aide Care Plan. On 09/29/2023 at 01:59 PM the Area Vice President of Operations stated that the precautions are inherent in the directions to assist the patient with ambulation, transfers and stand by assist with ambulation. HV Patient #9 – This 82-year-old patient with diagnoses that include encounter for orthopedic aftercare, other acquired deformities of the left foot, and aortic aneurysm of unspecified site, without rupture was admitted to the agency on 08/18/2023. Review of the PT OASIS Admission note dated 08/18/2023 revealed the following: Integumentary: Surgical wound known but not observable due to non-removable dressing/device. L (left) ankle/foot SX (unknown abbreviation) site, covered by dressing and brace, not to be removed until ortho (orthopedic) follow ups on 8/24 and/or 8/31. During an observational home visit on 09/12/2023 at 09:05 AM, the surveyors observed the patient to remove a boot from his left foot/leg. Review of the Home Health Certification and Plan of Care for certification period 08/18/2023 to 10/16/2023 lacked documented evidence of the brace/boot. During an interview on 09/28/2023 at 03:04 PM, the Physical Therapist stated that he typically tries to put the patient’s use of a boot at the beginning of the plan of care. He continued to state that the patient may not have had the boot initially after surgery but may have obtained at a later visit. As of exit, no further information was provided to refute the findings. Patient #10 – This 70-year-old patient with diagnoses that include pressure ulcer of right buttock, stage 4, morbid (severe) obesity with alveolar hypoventilation, and peripheral vascular disease was admitted to the agency on 08/09/2023. Review of the RN OASIS Admission dated 08/09/2023 revealed the RN documented the following: Does the patient have a willing and able caregiver to provide assistance: Yes. Determine the ability and willingness of family members, friends, or privately paid caregivers to provide assistance in the below areas (mark all that apply): ADL (Activities of Daily Living) Assistance (transfer/ambulation, bathing, dressing, toileting, eating/feeding). IADL (Instrumental Activities of Daily Living) Assistance (Meals, housekeeping, laundry, telephone, shopping, finances). Medication administration (oral, inhaled, or injectable). Advocacy or facilitation od patient’s participation in appropriate medical care (transportation to or from appointments). Indicate other details on patient assistance or caregiver support needs: Patient has a friend in building who is willing to help and has private pay aids through Medicaid. Narrative: Patient has no family available and has paid aide services through Medicaid to assist her. Review of the Home Health Certification and Plan of Care for certification period 08/09/2023 to 10/07/2023 laced documented evidence of an order for the patient’s use of private pay aides through Medicaid. During an interview on 09/29/2023 at 03:34 PM, the RN stated that the patient received aide services two (2) times a week through her senior living apartment prior to her hospitalization and not sure what the patient was receiving after her hospitalization. The RN continued to state that she did not believe that there was an order for the aide services on the plan of care. HV Patient #11 – This 75-year-old patient with diagnoses that include Alzheimer’s disease, dementia in other diseases classified elsewhere, unspecified severity, with agitation, and iron deficiency anemia was admitted to the agency on 08/12/2023. During an observational home on 09/13/2023 at 10:00 AM, the surveyor observed the patient to be sitting in a lift chair. The PT instructed the patient to use the remote to raise the lift chair up and assisted the patient to a stand position from the lift chair. Review of the Home Health Certification and Plan of Care for certification period 08/12/2023 to 10/10/2023 revealed DME (Durable Medical Equipment) and Supplies: beside commode; cane; long-handled shower; shower chair; and walker. There is a lack of documented evidence of the lift chair under DME on the Plan of Care. During an interview on 09/28/2023 at 01:49 PM, the CM stated that adding the lift chair as DME to the Plan of Care is a limitation in the agency’s software and clinicians do not have the ability to add the lift chair.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with agency staff, for four (4) of seventeen (17) patients (Patient #s: 12, 13, 15, and 17), the agency failed to provide services in accordance with physician orders. Failure to ensure patient care is provided in accordance with physician orders has the potential for patients to receive poor care and for health care needs to go unmet. Patient #17 - This 67-year-old patient with diagnoses that include malignant neoplasm of the hypopharynx, dysphagia, encounter for attention to gastrostomy, and hemiplegia following cerebral infarct affecting right dominant side was admitted to the home care agency on 08/22/2023. The agency failed to ensure patient care is provided in accordance with physician orders as evidenced by the following: A. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the Occupational Therapist (OT) is to obtain an oxygen saturation and notify MD (medical doctor) if oxygen saturation is below 90% after 10 (ten) minutes of rest. Review of the OT Add-On Evaluation visit dated 08/29/2023 revealed there is no documentation of an oxygen saturation. During interview on 09/27/2023 at 02:35 PM, the OT stated that she was told not to do an oxygen saturation during an evaluation visit because there is no order to do so. During interview on 09/27/2023 at 02:36 PM, the Clinical Manager stated she had never been told not to obtain an oxygen saturation during an initial evaluation. The Clinical Manager stated that if there is an order that contains parameters the clinician should be checking, and the OT did not obtain an oxygen saturation at this visit. B. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the Skilled Nurse (SN) is to assess patient’s ability to monitor and record daily weights and vital signs, including pulse and blood pressure; scales and blood pressure monitor to be provided if needed. Review of the RN (Registered Nurse) Subsequent Visit dated 09/06/2023 revealed there is no documentation of weight. During interview on 09/27/2023 the RN Case Manager stated I do not recall notifying the doctor about the patient’s inability to weigh himself. The RN Case Manager stated that the patient was unable to stand on the scale without holding on to something and that as a result of this the patient was unable to get an accurate weight. C. Review of the agency’s policy entitled “Administration of Enteral Feedings – Gastrostomy or Jejunostomy Tube” last reviewed 03/07/2023 revealed the following: “Procedure…7. Verify feeding tube placement following Physician orders. Recommended verification approaches include: a. For a gastrostomy tube attach syringe and aspirate gastric secretions…b. Return the aspirated content in accordance with Physician orders (if less than 250cc (cubic centimeters). Notify the Physician if the residual volume is greater than 250 cc…” Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the SN is to check residual with every feed (order does not include what the SN is to do with the aspirated contents). Review of the RN Subsequent Visit dated 08/30/2023 revealed the RN “flushed the J-tube with 200 cc of free water.” There is a lack of documented evidence the RN verified placement or checked residuals prior to flushing the patients feeding tube. Review of the RN Subsequent Visit dated 09/06/2023 revealed the RN “flushed the J-tube with 250 cc of free water.” There is a lack of documented evidence the RN verified placement or checked residuals prior to flushing the patients feeding tube. During interview on 09/25/2023 at 03:45 PM, the Clinical Manager stated, “I don’t know what he would do with residuals, there is no order.” During interview on 09/27/2023 at 09:32 AM, the RN Case Manager stated the patient has a PEG tube, not a J-tube, and that she made an error in her documentation. Patient #15 - This 83-year-old patient with diagnoses that include hypertensive heart disease with heart failure, chronic obstructive pulmonary disease, and atrial fibrillation was admitted to the home care agency on 08/24/2023. The agency failed to ensure patient care is provided in accordance with physician orders as evidenced by the following: Review of the Home Health Certification and Plan of Care for certification period 08/24/2023 to 10/22/2023 revealed the Physical Therapist (PT) is to assess and record patient weight and notify CM (Clinical Manager) or RN (Registered Nurse) Case Manager for MD (Medical Doctor) notification for signs and symptoms of exacerbation (2 lb. (pound) weight gain in one (1) day, 5 lbs. in a week or 5 lbs. over baseline). Review of the PT/PTA (Physical Therapy Assistant) Subsequent Visit dated 08/29/2023 revealed there is no documentation of weight. During interview on 09/27/2023 at 09:02 AM, the PT 2 stated he does not believe he obtained a weight. Patient #13 - This 83-year-old patient with diagnoses that include third (oculomotor) nerve palsy, right eye, type 2 diabetes mellitus, and essential hypertension was admitted to the home care agency on 09/04/2023. The agency failed to ensure patient care is provided in accordance with physician orders as evidenced by the following: A. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the following orders: Physical Therapist (PT) for diabetes management and patient/caregiver to perform finger sticks three times per day and report if blood glucose is less than 60 or greater than 400. Review of the PT OASIS Admission dated 09/04/2023 revealed the PT documented the following: the patient has diabetes that is managed by insulin, oral antidiabetics and diet, the insulin is administered by an insulin pen, the patient cannot self-inject due to poor manual dexterity, cognitive impairment and impaired vision, blood sugars are checked daily, and the range of the patient’s usual blood sugar reading are unknown. There is no documentation of a blood glucose reading. During interview on 09/25/2023 at 11:05 AM, the PT stated from what she recalls there were a lot of family dynamics, and she does not know why the patient was not checking her blood sugars. The PT stated that she does not know what the patient’s blood sugar was at the time of her visit because the patient had not been checking her sugars since she got home from sub-acute rehab on 08/31/2023. Lastly, the PT stated that the doctor was notified about the patient non-compliance with blood sugar checks, however these conversations were not clearly documented. Review of the PT Routine Visit dated 09/09/2023 revealed the PT documented the patient has no abnormal endocrine/hematopoietic findings. There is no documentation of a blood glucose reading. During interview on 09/27/2023 at 02:49 PM, the PT stated that the patient does have diabetes and that she documents no abnormal endocrine/hematopoietic findings when the patient is not experiencing any signs or symptoms of hypo or hyperglycemia. Additionally, the PT stated that she asked the patient if she was having trouble checking her blood sugars and that what she remembers is that the patient’s glucometer was broken, and she possibly did not have supplies. B. Review of the Occupational Therapy (OT) Add-On Discipline Plan of Care dated 09/06/2023 revealed the OT will report BS (blood sugar) outside of parameters to primary MD (medical doctor). Review of the OT Add-On Evaluation dated 09/06/2023 revealed the OT documented the patient has no abnormal endocrine/hematopoietic findings. There is no documentation of a blood glucose reading. During interview on 09/27/2023 at 02:00 PM, the OT stated she was unable to take a blood sugar test because the patient’s glucometer was not working and that several family members stated they need to get the patient a new glucometer. The OT also stated that when she documents vital signs there is an option for the clinician to select ‘unable’ if for some reason the clinician is unable to obtain a value. During interview on 09/27/2023 at 02:05 PM, the Clinical Manager stated the blood glucose is not documented and the agency expectation is that there should be documentation of an explanation as to why the clinician is unable to carry out the order. C. Review of the Add-On Discipline Plan of Care dated 09/08/2023 revealed the following orders: Skilled Nurse (SN) for instructions of diabetic care to include blood glucose testing per MD orders, assess patient/caregiver ability to perform and record blood glucose testing as ordered and to report abnormal findings to the physician, and to report to physician blood glucose readings “greater than 70 or less than 350.” Review of the RN Add-On Evaluation dated 09/08/2023 revealed the RN documented the patient has diabetes that is managed by insulin, oral antidiabetics, and diet, insulin is administered by an insulin pen, the patient cannot self-inject due to poor manual dexterity due to ortho/arthritic/neurological manifestations and impaired vision, no blood sugar checks have been ordered by the physician, patient has not checked blood sugar readings, glucometer recommended, and the patient’s daughter has a glucometer but it is not working. There is no documentation of a blood glucose reading. During interview on 09/28/2023 at 09:03 AM, the RN Case Manager stated that the meaning behind her documentation “no blood sugar checks ordered by MD” means that when she called the doctor, the doctor responded that the patient does not need to check her blood sugars at home. The RN Case Manager stated that her order reflects her conversation with the doctor and that she did not need to check the patient’s blood glucose because the order says “may.” Lastly, the RN Case Manager stated she does not see a note that specifies that the doctor stated the patient does not need to check her blood sugar, nor does she see documentation regarding physician notification of the patient’s non-compliance with testing or the broken glucometer. D. Review of the OT Add-On Discipline Plan of Care dated 09/06/2023 revealed the OT will notify MD if O2 (oxygen) saturations fall below 90% after 10 minutes of rest. Review of the OT Add-On Evaluation lacked documented evidence of an O2 saturation During interview on 09/27/2023 at 01:50 PM, the OT stated she thinks that with her, she attempted many times and was unable to obtain an oxygen saturation. Patient #12- This 80 year old patient with diagnoses that include Encounter for orthopedic aftercare following surgical amputation, Type II Diabetes, and personal history of diabetic foot ulcer was admitted to the agency on 06/25/2023. This patient resides in an Assisted Living facility. The agency failed to ensure patient care is provided in accordance with physician orders as evidenced by the following: Review of the Home Health Certification and Plan of Care for certification period 06/25/2023 to 08/23/2023 revealed the Skilled Nurse is to assess, evaluate and develop an individualized plan of care, to assess/ evaluate co-morbid conditions and any new conditions that present themselves during this episode to identify changes and intervene to minimize complications. Under goals/rehabilitation potential/discharge plans, “Patient’s blood sugar will remain well controlled throughout episode of care and patient will not have any signs of skin breakdown or complications. Review of the SN Subsequent Visits dated 08/10/2023 revealed the RN was conducting the visit for a new wound, a diabetic ulcer, located on the right plantar foot. There is no documentation of a blood sugar or blood sugar ranges on this date, or any documentation to show that the SN monitored the patient’s blood sugars to ensure they were well controlled. Review of the SN Subsequent Visits dated 08/14/2023 and 08/17/2023 revealed there is no documentation of sugars or blood sugar ranges. Review of the Home Health Certification and Plan of Care for certification period 08/24/2023 to 10/22/2023 revealed the order “Diabetes management: Skilled Nurse for instructions of diabetic care to include diet, skin care, signs and symptoms of hypo/hyperglycemia…blood glucose testing daily, Skilled Nurse to assess patient/caregiver ability to perform and record blood glucose testing as ordered and to report abnormal findings to physician. Skilled Nurse may perform blood glucose test as needed. Skilled Nurse to report to physician blood glucose readings greater that 400 or less than 60.” Review of the SN Subsequent Visits dated 08/24/2023 and 08/28/2023 revealed there is no documentation of the patient’s blood sugar readings or documentation of blood sugar ranges. During interview on 10/05/2023 at 03:18 PM the Area Vice President of Clinical stated that it is the agency’s expectation to record and monitor the blood sugars.

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 review of clinical records and interviews with agency staff, three (3)of seventeen (17) patients (Patient #s: 10, 15, and 17) the agency failed to ensure drugs and treatments are administered in accordance with physician orders. Failure to administer drugs and treatments without a physician's order has the potential to result in poor quality of care. Patient #17 - This 67-year-old patient with diagnoses that include malignant neoplasm of the hypopharynx, dysphagia, encounter for attention to gastrostomy, and hemiplegia following cerebral infarct affecting right dominant side was admitted to the home care agency on 08/22/2023. A. Review of the Dietician Add-On Evaluation dated 09/07/2023 revealed the Dietician documented the patient consumes two (2) t0 three (3) cans of Ensure per day. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 lacked an order for Ensure. The agency failed to obtain an order for Ensure. During interview on 10/03/2023 at 02:28 PM, the Dietician 2 stated there is not an order for Ensure, and she would have put it in her order however the tube feed was on her mind. B. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the following order: Nutritional Requirements: six (6) cans Jevity 1.5 bolus daily, tube feedings. Review of the OT (Occupational Therapy) Add-On Evaluation dated 08/29/2023 revealed the OT documented the patient states he is having some difficulty swallowing but if he “chews enough” he does not have any problems. Review of the ST (Speech Therapy) Add-On Evaluation dated 08/30/2023 revealed the ST documented the patient has a PEG (percutaneous endoscopic gastrostomy) tube (a feeding tube used to deliver nutrition through the stomach) that he is not currently using, the current diet is mechanical soft, and the patient has been diagnosed with dysphagia and it is recommended he consume a soft diet with nectar thickened liquids. During interview on 10/03/2023 at 10:57 AM, the Speech Language Pathologist (SLP) stated at the time of her evaluation the patient stated that the PEG tube was placed as a precaution and in anticipation of his upcoming need for chemotherapy and radiation. The SLP stated that at the time of her evaluation the patient was on an oral diet but that she did not see an order for the mechanical soft diet that she referenced in her documentation. Lastly, the SLP stated that it was her understanding that the patient came home on a mechanical soft diet with thickened liquids and that she would only contact the doctor for an order if she was changing the diet. Review of the RN (Registered Nurse) Subsequent Visit dated 08/30/2023 revealed the RN documented the patient states he has been tolerating PO (by mouth). During interview on 09:27 AM at 09:26 AM, the Clinical Manger stated the doctor was made aware of his diet and mechanical soft was his choice, but she inadvertently did not put in an order. The Clinical Manager also stated that the patient was not utilizing his feeding tube at this time because he was eating and did not need it. Review of the RN Subsequent Visit dated 09/06/2023 revealed the RN documented the patient continues to take PO with thin liquids and states he is tolerating well. During interview on 09/27/2023 at 09:51 AM, the RN Case Manager stated the patient told her that he was doing this. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 lacked an order for an oral diet. Patient #15 - This 83-year-old patient with diagnoses that include hypertensive heart disease with heart failure, chronic obstructive pulmonary disease, and atrial fibrillation was admitted to the home care agency on 08/24/2023. Review of the OT (Occupational Therapy)/OTA (Occupational Therapy Assistant) Subsequent Visit dated 09/01/2023 revealed the OTA documented she completed education review on the importance of following with incentive spirometer throughout the day to strengthen respirations and better activity tolerance with attempting to titrate from current 2 liters of oxygen at all times. Review of the OT/OTA Subsequent Visit dated 09/07/2023 revealed the OTA documented she titrated oxygen during activity to maintain oxygen saturation greater than 90% during activity and that the patient’s oxygen saturation was 97% on 2 liters of oxygen. Review of the Home Health Certification and Plan of Care for certification period 08/24/2023 to 10/22/2023 lacked an order for an incentive spirometer and an order for oxygen titration. The agency failed to obtain an order for incentive spirometry and oxygen titration. During interview on 09/25/2023 at 11:25 AM, the OTA stated there is no order for incentive spirometry. The OTA stated that during her visit the patient was not using an incentive spirometer, but it was on the stand next to him. Additionally, the OTA stated that she did not attempt to titrate the patient’s oxygen and he was on oxygen the entire visit. During interview on 09/25/2023 at 11:27 AM, the Clinical Manager stated if it was in the home there should be an order for it. Additionally, the Clinical Manager stated that there is not an order for titration, so there should not be a goal, and that it must be a Home Care Home Based (electronic medical record system) issue. The Clinical Manager stated that if it is not an order it should not be an intervention. Lastly, the Clinical Manager stated that she would have to investigate the issue. As of exit, no further information was provided to refute the findings. Patient #10 – This 70-year-old patient with diagnoses that include pressure ulcer of right buttock, stage 4, morbid (severe) obesity with alveolar hypoventilation, and peripheral vascular disease was admitted to the agency on 08/09/2023. Review of the LPN (Licensed Practical Nurse) Subsequent Visit dated 08/25/2023 revealed the following: Pain: Pain in lower extremities – BLE (bilateral lower extremity), right buttock. Was the patient was instructed to pre-mediate prior to wound care: Yes. Indicate details of medication administration prior to wound care and outcome: Advil. Narrative: Spoke to primary about pulse and OTC (over the counter) medication Advil. Advil 2 tablets TID (three times a day). Review of the Home Health Certification and Plan of Care for 08/09/2023 to 10/07/2023 lacked an order for Advil. Review of the Physician Orders from 08/09/2023 to 09/12/2023 (date of home visit) lacked an order for Advil. During an interview on 09/29/2023 at 01:59 PM, the Director of Operations (DOO) stated that she would except to see an order for the patient’s use of Advil. The DOO continued to state that she is not sure if the LPN mixed the two medications up or if she documented incorrectly and that she will have to reach out to the nurse to find out. During an interview on 09/29/2023 at 03:02 PM, the LPN stated that the patient was using Advil two (2) tablets three (3) times a day. As of exit, no further information was provided to refute the findings.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with staff for one (1) of seventeen (17) patients (Patient #5), the agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's current status. Failure to ensure the POC is updated and revised has the potential to result in negative patient outcomes. The agency failed to ensure the plan of care is reviewed and updated to include a pain medication regimen that addresses the patient’s pain as evidenced by the following: Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. A.) Review of the RN (Registered Nurse) Subsequent Visit dated 09/12/2022 revealed the RN documented that the patient has pain daily, but not constantly. In the Vital Sign portion of the documentation, the RN documented the patient’s pain as 1 out of 10 (with 0 being no pain and 10 being the worst pain experienced). The pain assessment revealed the maximum pain in the past 5 days was reported as 3/10 The pain is located in the left lower extremity and was characterized as aching and tender. Additionally, the RN documented under interventions, “Instruct on appropriate pain management techniques…Taking medications as prescribed while pain is still tolerable.” Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed there is no order for pain medications. During interview on 09/26/2023 at 02:45 PM the Clinical Manager stated that the RN should have done an accurate pain medication reconciliation and checked to see if pain medication was in place. B.) Review of the RN (Registered Nurse) Subsequent Visit dated 09/21/2022 revealed the RN documented that the patient has pain daily, but not constantly. In the Vital Sign portion of the documentation, the RN documented the patient’s pain as 1 out of 10 (with 0 being no pain and 10 being the worst pain experienced). The pain assessment revealed the minimum pain in the past 5 days was 2/10 and maximum pain was 4/10 (which has increased since the previous RN visit on 09/12/2022). The RN documented that the patient’s pain that occurred “all the time,” is generalized, aching and relieved by distraction, but is tolerable. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed there is no order for pain medications. During interview on 09/26/2023 at 02:45 PM the Clinical Manager stated that the RN should have done an accurate pain medication reconciliation and checked to see if pain medication was in place. C.)Review of the RN (Registered Nurse) Subsequent Visit dated 10/03/2022 revealed the RN documented that the patient has pain daily, but not constantly. In the Vital Sign portion of the documentation, the RN documented the patient’s pain as 2 out of 10 (with 0 being no pain and 10 being the worst pain experienced). The pain assessment revealed the minimum pain in the past 5 days was 0/10 and maximum pain was 4/10, which occurred daily but not constantly, is generalized and aching. Additionally, the RN documented under interventions, “Instruct on appropriate pain management techniques…Taking medications as prescribed while pain is still tolerable.” Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed there is no order for pain medications. During interview on 09/26/2023 at 02:57 PM the Clinical Manager stated that the Skilled Nurse should have brought the Ibuprofen order from the preadmission face-to-face over to the plan of care.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on review of clinical records and interview with agency staff for two (2) of seventeen (17) patients (Patient #s: 6 and 9), the agency staff failed to promptly alert the physician to any changes in the patient's condition that suggests the need to alter the plan of care (POC). Failure to promptly notify the physician to any changes in the patient's condition that suggests the plan of care should be altered has the potential to result in unmet patient needs and negative patient outcomes. Patient #6- This 64 year old patient with diagnoses that include Ataxia following cerebral infarction, chronic atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the agency on 06/09/2023. This patient is receiving therapy only services. The agency failed to ensure the physician was promptly notified of a change in the patient’s status as evidenced by the following: Review of the 06/23/2023 OT/OTA Subsequent Visit dated 06/23/2023 revealed the Certified Occupational Therapy Aide (COTA) documented “Clinician noted closed trauma wound to RLE (Right lower extremity)/foot with the foot appearing reddened and slight edema; education provided to caregivers present and sister [name] via text to keep area dry and clean (dial soap and water) and elevate when possible; furthermore if any changes in appearance occur PT/caregiver need to contact PMD or [agency] as soon as change is noted so area can be monitored properly.” Additionally, the COTA documented that the clinician manager was notified regarding the trauma wound.” Review of the Coordination Notes for 06/23/2023 to 07/01/2023 revealed there is no documentation of communication between the COTA and Clinical Manager regarding the closed foot trauma or whether the physician was notified. During interview on 09/29/2023 at 10:18 AM the COTA stated that she was not sure how the injury occurred. The COTA stated that when she arrived for the visit and saw the trauma, she asked the patient how it occurred, and the patient could not recall. The COTA stated that she emailed the Clinical Manager to notify the Clinical Manager of the trauma, she did not notify the physician. During interview on 09/29/2023 at 01:28 PM the Director of Operations stated that the physician was not notified. Patient #9 – This 82-year-old patient with diagnoses that include encounter for orthopedic aftercare, other acquired deformities of the left foot, and aortic aneurysm of unspecified site, without rupture was admitted to the agency on 08/18/2023. Review of the PT (Physical Therapy) OASIS (Outcome and Assessment Information Set) Admission dated 08/18/2023 revealed the PT documented the following: yes, abnormal findings in gastrointestinal assessment, constipated, and last bowel movement was on 08/14/2023. Review of the clinical record from 08/18/2023 to 09/12/2023 lacked documented evidence that the physician was notified of the patient’s constipation. During an interview on 09/28/2023 at 03:01 PM, the PT stated that no, I don’t see that I documented that I notified the patient’s physician that the patient is constipated and that his last bowel movement was on 08/14/2023.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA 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). This ELEMENT is not met as evidenced by: Based on clinical record review and interview with agency staff, for one (1) of six (6) discharged patients (Patient #1), the agency failed to ensure that discharge planning was communicated with the patient/caregiver and the responsible physician prior to discharge from the agency. Failure to communicate discharge planning has the potential for unmet patient needs. The agency failed to ensure the patient and physician were fully informed of the agency’s plan to discharge the patient as evidenced by the following: Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. Review of the Home Health Certification and Plan of Care for certification period 03/12/2023 to 05/10/2023 revealed SN (Skilled Nursing) services were ordered as “1WK1, 2WK7, 1WK1, 1PRN.” Orders for SN include: -assessing and evaluating the patient for co-morbid conditions and any new conditions that present themselves during the episode; - reviewing medications for interactions, effectiveness of drug therapy and signs and symptoms of adverse reactions; -observing and assessing integumentary status to identify changes and intervene to minimize complications; -provide wound care and treatment to the right great toe, left great toe, and left 2nd toe; -to observe, assess and provide education on pain management techniques; and -provide fall reduction management Review of the SN Subsequent Visits from 04/10/2023 to 05/02/2023 revealed that LPN’s provided wound care on 04/10/2023, 04/13/2023, 04/06/2023, and 05/02/2023. Review of the Coordination Notes dated 04/23/2023 at 10:15 AM for a missed visit on 04/21/2023 (2 days after the visit was to occur) revealed that the RN documented a missed visit note for 04/21/2023. The note revealed that the Clinical Manager was notified that the missed visit occurred because the patient’s granddaughter refused the visit and requested that the visit not be rescheduled, and the visit was to be rescheduled to the next Medicare week. Additional comments state that the granddaughter requests visit at 4 PM, but “SN was not available at 4 PM due to ectend3d [sic] visit with prior patient. SN received a text at 4:20 that no one was available at patient’s home for visit.” There is no evidence the patient’s physician was notified at that time. Review of the Coordination Note dated 04/26/2023 revealed the LPN documented that wound care was provided. The LPN documented “left wound with necrotic eschar wounds, right foot with small serosanguinous drainage. No odor associated with no signs or symptoms of infection….PT (patient) has positive support from granddaughter and daughter who provide all care…they are waiting a possible wound clinic appt (appointment).” Review of the Coordination Note dated 04/28/2023 revealed the RN documented “SN text granddaughter 4/27/23 to set up visit time. Granddaughter requests visit between 8A-9A. SN stated visit can be at 9:45 Granddaughter declined.” The RN documented a missed visit that was reported to the Clinical Manager because the caregiver refused, and the patient requested that the missed visit not be rescheduled. There is no documentation to show that the patient/caregiver was educated on the risks and potential adverse outcomes as a result of refusing services. Additionally, there is no documentation to show that the agency took measures to obtain patient participation with the plan of care. Furthermore, there is no documentation to show that the physician was notified that the visit was missed because the agency was unable to accommodate the caregiver’s request for visits to be made between 8 AM and 9 AM. Review of the Coordination Note dated 05/01/2023 revealed the Clinical Manager documented “Coordination of care completed. Recertification visit scheduled. Recertification for Skilled Nursing Services for continued wound care management if caregivers agreeable. There is no documentation to show who was involved in the coordination of care, the date and proposed time of the scheduled recertification visit, and whether the visit was scheduled with participation of the patient/caregiver. It is unclear who was involved in the coordination of care, and whether the patient/caregiver, and physician were involved and/or made aware of the date for the visit. Review of the Coordination Note dated 05/04/2023 at 05:53 PM revealed the RN documented that there was a missed visit on 04/28/2023 (6 days after the missed visit). The note shows that the missed visit was reported to an individual at the physician’s office that the granddaughter refused the visit, and the visit was not rescheduled. Notification to the physician’s office occurred 6 days after the missed visit. There is no documentation explaining why the caregiver refused, whether the agency took measures to obtain patient participation with the plan of care, whether the patient/caregiver was educated on the risks and potential adverse outcomes as a result of refusing services, and whether the physician was fully notified about the circumstances leading up to the missed visits. Review of the Coordination Note dated 05/08/2023 at 09:55 AM revealed the RN documented a missed visit for that date, and that a voice mail was left on the nurse line at the physician’s office for the physician. Additionally, the Clinical Manager was notified. It is documented that the patient requested that the missed visit not be rescheduled. Additional comments state “Granddaughter requests visits at 8 AM, will not negotiate time.” There is no documentation on that date that the RN contacted the patient/caregiver by phone or another form of communication to schedule the visit, and that as a result of the conversation, the patient/caregiver refused the visit. Additionally, there is no documentation to show that the patient/caregiver was educated on the risks and potential adverse outcomes as a result of refusing services. Furthermore, there is a lack of documented evidence that the agency made efforts to resolve the problems leading to the missed visits. Review of the RN-Discharge Data Collection Only-No Visit Made dated 05/08/2023 at 08:21 AM to 10:17 AM, revealed the assessment was completed for “discharge from agency.” There is no documented evidence that the patient/caregiver or physician were made aware of the agency’s decision to discharge the patient. Review of the Coordination Note dated 05/11/2023 at 09:38 AM [3 days after the patient was discharged from the agency] revealed the RN Clinical Manager documented “Patient’s [caregiver] called to complain about ‘the nurses not showing up.” This RN explained that the nurses have offered several alternate times that have been declined for visits and the only times available are between 8-9 AM and this is not always able to be accommodated. The [caregiver] explained that she works overnight, and refuses visits any other time between 8-9 AM. When the nurse was 15 min (minutes) late, because the exact time wasn’t met’ They refused the visit and said, ‘contact the agency.’ This RN explained that ranges for visits must be given as schedule changes and emergencies happen with patients and we are required to give a range of time for visits. Again [caregiver] was not satisfied with this response. [Caregiver] stated [agency nurse name] was the last person here last week on Monday and now her foot is turning black on top. This RN recommended that ‘she needs to go to the emergency room immediately.” [Caregiver] continued to yell and stated “I called to talk to [name of agency employee]’… [Name] RN for family practice (the physician’s office) contacted this RN as [caregiver] also called the doctor’s office. [Name] wanted to know what was going on so she could notify the doctor. This RN explained that several visit times have been offered but the patient’s [caregiver] only allows visits between 8-9AM, we have offered different times in the ‘morning’ as requested but those are declined…This RN discussed that we have also spoken to the daughter about the need for more assistance with the wounds, such as a wound clinic, or doctor as the treatment is not improving the overall wound…This RN explained that the feet have remained black/necrotic and non-healing and need physician intervention. The [caregiver] had not taken her to do this. When we found out about the wounds, they would only take her to the emergency department. This RN stated ‘I was going to contact APS (Adult Protective Services) as it has now been 3 weeks with multiple missed visits and I am concerned about who cares for her while [caregiver] is sleeping and the [second caregiver] is not available to come over and let the nurse in…” There is no documentation that the patient/caregiver was notified that the patient was actually discharged on 05/08/2023, or that the physician was notified of the patient’s discharge. Review of the Coordination Note dated 05/14/2023 at 09:17 PM revealed the RN documented a missed visit for 05/05/2023 (9 days after the visit was missed and 6 days after the patient was discharged). Review of the Coordination Note dated 05/16/2023 (8 days after the patient was discharged from the agency) revealed the agency mailed the patient a Notice of Medicare Non-Coverage (NOMNC). The RN documented that the NOMNC was “mailed due to multiple missed visits and certification lapse.” There is no documented evidence that the physician was notified of the discharge. Additionally, the patient was discharged on 05/08/2023, prior to the date the new certification period would begin. During interview on 09/28/2023 at 11:03 AM the Clinical Manager stated that she could not speak to how the physician was notified about the decision to discharge the patient. She stated that the patient was not discharged until after the certification period ended, and the NOMNC was mailed to the patient on 05/16/2023. Additionally, the patient’s caregiver only wanted nurses to visit between 8 and 9 AM. When the nurses were not at the home at those times, the caregiver refused the visits. When asked whether the caregiver was notified of the patient’s discharge during the 05/11/2023 telephone call when the caregiver called to complain that the nurses were not showing up, the Clinical Manager stated that the patient was not discharged at the time that the Coordination Note was written, and that is why that information is not in the note. During interview on 09/28/2023 at 11:07 AM the Director of Operations (DOO) stated that the patient discharge date in their computer system is 05/08/2023, and that 60 days was “up on the 8th.” The DOO stated that the agency’s electronic record system would not allow the agency to send the NOMC until 05/16/2023, after the certification period lapsed.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for one (1) of six (6) therapy only cases (Patient # 11), the agency failed coordinate care delivery to meet the patient’s needs. Specifically, the Physical Therapist Assistant (PTA) failed to notify the agency’s Physical Therapist (PT) that the patient had seen his physician, had a urine test and waiting on culture. Failure to coordinate care delivery has the potential for negative patient outcomes. Patient #11 – This 75-year-old patient with diagnoses that include Alzheimer’s disease, dementia in other diseases classified elsewhere, unspecified severity, with agitation, and iron deficiency anemia was admitted to the agency on 08/12/2023. Review of the PT/PTA Subsequent Visit note dated 08/16/2023 revealed the PTA documented the following: - No changes in genitourinary findings since last visit. - Patient is present when I arrived. Vitals assessed. Patient saw PMD (Primary Medical Doctor) Monday. Had urine test. Waiting on culture. Wife said initial test was positive for UTI (Urinary Tract Infection). Review of the clinical record from 08/12/2023 to 09/13/2023 (date of home visit) lacked documented evidence that PTA notified the Physical Therapist of the patient going to his PMD and possibly having a UTI. During an interview on 09/28/2023 at 02:27 PM, the PTA stated that the patient did not end up having a UTI and was not started on an antibiotic. The PTA continued to state that she did communicate with the PT by phone call that the patient had seen his physician on Monday, had a urine test, waiting on the culture, and that wife said the initial test was positive for UTI but may have not documented the communication with the PT in the patient’s clinical record. She continued to state that she may have communicated with the PT via e-mail.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on review of the agency's Quality Assurance Performance Improvement (QAPI) program and staff interview it was determined the agency failed to analyze, and track quality indicators, including patient events to implement adequate action plans to lead to measurable improvements in areas identified and to maintain an agency wide program for the surveillance, investigation prevention and control of infectious diseases as part of the QAPI program. Failure to implement effective measures to improve care and prevent infectious and communicable diseases has the potential for patient harm. A.) Review of the Agency Patient-Related Characteristics (Case Mix) Report for period 06/2022 to 05/2023 revealed the agency’s incidence of any falls since Start of Care (SOC)/Resumption of Care (ROC) is listed as 12.36% compared to the national average for home health agencies of 8.42%. Review of the agency’s Potentially Avoidable Event Overview report dated 04/11/2022, and 10/10/2022, revealed the agency identified that the agency’s incidences of falls with major injury, minor injury and no injury were well above the national average and State average. Review of the Quality Assurance Performance Improvement Program (QAPI) documentation revealed that the agency failed to demonstrate that it conducted a review of the clinical records of patients identified as having falls, with and without injury, and implemented effective measures to improve care and prevent further adverse patient outcomes. During interview on 10/05/2023 at 09:32 AM the Director of Operations (DOO) stated that the agency’s current Performance Improvement Projects are acute hospitalizations, and quality metrics. She stated that if the agency sees trends, then the agency would track them. The DOO stated that during QAPI the agency discusses action plans, and the agency maintains an agenda, but meeting minutes are not recorded. B.) Review of the agency’s Professional Advisory Group (PAG) Meeting Agendas revealed the following: -05/24/2022: the agency identified 43 infections; -05/16/2023: the agency identified 52 infections; -02/21/2023: the agency identified 68 infections; -05/16/2023: the agency identified 52 infections; -08/15/2023: the agency 62 infections (30 Urinary Tract Infections, 12 respiratory, and 20 wound); -08/23/22: the agency identified 60 infections; and -11/22/2022: the agency identified 19 infections. There are no QAPI Meeting Minutes that address the infections outlined in the PAG Meeting Agendas. Additionally, there is no documentation to the types of infections, or evidence the agency is investigation and/or analyzing sources or causative factors of infection, tracking and putting a plan in place to prevent infections. There is no documented performance improvement initiatives to indicate what the agency is doing in an attempt to prevent infections. During interview on 10/05/2023 at 09:32 AM the Director of Operations (DOO) stated that the agency’s current Performance Improvement Projects are acute hospitalizations, and quality metrics. She stated that if the agency sees trends, then the agency would track them. The DOO stated that during QAPI the agency discusses action plans, and the agency maintains an agenda, but meeting minutes are not recorded.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for two (2) of seventeen (17) patients (Patient #s: 1 and13) the agency failed to ensure the patient/caregiver is provided with appropriate education in order to carry out the plan of care. Failure to educate the patient/caregiver has to potential for unmet patient needs, provision of inappropriate care and patient harm. Patient #13 - This 83-year-old patient with diagnoses that include third (oculomotor) nerve palsy, right eye, type 2 diabetes mellitus, and essential hypertension was admitted to the home care agency on 09/04/2023. Review of the Home Health Certification and Plan of Care for certification period 09/04/2023 to 11/02/2023 revealed the following: - Type 2 diabetes - Physical Therapist (PT) for diabetes management. - Patient/caregiver to perform finger sticks three (3) times per day and report if blood glucose is less than 60 and greater than 400. -Skilled Nurse (SN) for instructions of diabetic care to include diet – no concentrated sweets, signs and symptoms of hypo/hyperglycemia, proper administration of diabetic medication, blood glucose testing per MD (medical doctor) orders, assess patient/caregiver ability to perform and record blood glucose testing as ordered and report abnormal findings to physician, perform blood glucose test as needed, and report to physician blood glucose readings “greater than 70 or less than 350.” - The patient's diabetic medications include: Humalog U – 100 Insulin 100 unit/ml (milliliter) subcutaneous, use sliding scale, before meals and at bedtime. Sliding scale: 170 – 209 (1 unit), 210 – 249 (2 units), 250 – 289 (3 units), 290 – 329 (4 units), 330 – 369 (5 units), 370 – 400 (6 units), call MD if BG is less than 60 or greater than 400; Januvia 100mg (milligram) tablet by mouth daily; Lantus U-100 Insulin 100 unit/ml subcutaneous, 15 units at bedtime; Metformin 1,000mg tablet, by mouth two times per day; and Trulicity 0.75mg/0.5ml subcutaneous, give one injection weekly on Sundays. A. Review of the PT OASIS Admission note dated 09/04/2023 revealed the PT documented the patient has diabetes that is managed by insulin, oral antidiabetics, and diet; insulin is administered by an insulin pen; the patient cannot self-inject due to manual dexterity due to ortho/arthritic/neurological manifestations, cognitive impairment, and impaired vision; and a caregiver is willing to provide injections. There is no documented evidence that the PT assessed the caregiver’s ability to perform finger sticks or that there was appropriate re-demonstration on the part of the caregiver. The PT failed to ensure the caregiver was able to successfully demonstrate the ability to obtain a blood glucose independently. B. Review of the RN (Registered Nurse) Add-On Evaluation dated 09/08/2023 revealed the RN documented the patient has diabetes that is managed by insulin, oral antidiabetics, and diet; insulin is administered by an insulin pen; the patient cannot self-inject due to manual dexterity due to ortho/arthritic/neurological manifestations, and impaired vision; a caregiver is willing to provide injections; no blood sugar checks ordered by physician; patient has not checked blood sugar readings; recommended a glucometer; and daughter has a glucometer but it is not working. There is no documented evidence that the RN assessed the caregiver’s ability to perform proper administration of diabetic medication and blood glucose testing or that there was appropriate re-demonstration on the part of the caregiver. The RN failed to ensure the caregiver was able to successfully demonstrate the ability to properly administer diabetic medication or obtain a blood glucose independently. During interview on 09/25/2023 at 11:00 AM, the Clinical Manager stated that documentation of the caregiver’s ability is not in the patient’s medical record. The Clinical Manager stated there should be documentation of the caregiver’s verbalization of their ability to perform the task or documentation of re-demonstration of the task by the responsible caregiver. Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. Review of the Physician Order dated 01/20/2023 revealed the following order: SN (Skilled Nurse) to cleanse wound left great toe with wound cleanser, apply Medihoney to wound, cover with dry gauze dressing, secure with tape 3 x weekly and PRN (as needed) dressing dislodgement. Caregiver performs wound care when SN not present. Review of the Physician Orders from 01/21/2023 to 03/11/2023 revealed there are no new orders for wound care to the left great toe wound. Review of the Home Health Certification and Plan of Care for certification period 03/12/2023 to 05/10/2023 revealed the order for the left great toe was changed to: cleanse wound Left great toe with wound cleanser, apply Silvadene to wound, cover with dry gauze, secure dressing with tape 3 x weekly and PRN dislodgement. Caregiver performs wound care when SN not present. Review of the SN Subsequent Visit dated 03/13/2023 revealed the RN provided wound care to the left great toe as ordered (Silvadene). Additionally, the RN documented that the patient’s daughter is able to perform wound care when SN is not present. There is no documented evidence that the RN informed the daughter that the treatment changed, that the RN provided education and training, and that the daughter was able to redemonstrate the ability to provide appropriate care to the wound. During interview on 09/28/2023 at 12:24 PM the Clinical Manager stated that the narrative stated that the patient’s daughter is able to provide wound care when the SN is not present, but there is no specific documentation to state that the daughter was informed of the change in the treatment, and that redemonstration was provided.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for nine (9) of seventeen (17) patients (Patient #s: 1, 5, 6, 7, 8, 9,10, 12, and 17), the agency failed to ensure all clinical notes are complete and accurate and contain all pertinent information about the patient’s current status. Failure to document complete and accurate clinical and progress notes has the potential for unmet patient needs. The agency failed to ensure all clinical notes are complete and accurate as evidenced by the following: Patient #17 - This 67-year-old patient with diagnoses that include malignant neoplasm of the hypopharynx, dysphagia, encounter for attention to gastrostomy, and hemiplegia following cerebral infarct affecting right dominant side was admitted to the home care agency on 08/22/2023. A. Review of the Home Health Certification and Plan of Care for certification period 08/22/2023 to 10/20/2023 revealed the following order: Enteral feeding care/teaching: Skilled Nurse (SN) to perform and instruct in management of gastrostomy tube in left lower quadrant. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission dated 08/22/2023 revealed the RN documented 18 French gastrostomy tube in the left lower quadrant that is clean, dry and intact. Review of the RN Subsequent Visit dated 08/30/2023 revealed the RN “flushed the J-tube with 200 cc (cubic centimeters) of free water.” Review of the RN Subsequent Visit dated 09/06/2023 revealed the RN “flushed the J-tube with 250 cc of free water.” During interview on 09/27/2023 at 09:32 AM, the RN Case Manager stated the patient has a PEG tube, not a J-tube, and that she made an error in her documentation. B. Review of the RN OASIS Admission dated 08/22/2023 revealed the RN documented the following: patient lives alone and has no assistance, does not have a willing and able caregiver to provide assistance, has a niece and reports that “she helps when I call her”, has “multiple friends in the building that help me and take me to the grocery store and errands”, no significant caregivers available for continued support in the home, intermittent support only reported by patient from family and friends outside the home, non-agency caregivers are not likely to provide assistance or it is unclear if they will provide assistance, and has an 18 French gastrostomy tube that the patient manages in the absence of the SN. During interview on 09/25/2023 at 03:40 PM, the Clinical Manager stated that she should have entered a note stating the patient was independent with PEG tube management and feeds at the start of care and that the patient can check for residuals, but it is difficult for him to do so. Additionally, the Clinical Manager stated at opening the patient was being tube fed, utilizing bolus method and that she showed him how to do it. Review of the ST (Speech Therapy) Add-On Evaluation dated 08/30/2023 revealed the ST documented that the patient has a PEG tube that is not currently in use and there is no family or non-paid caregivers involved in the patient’s care. During interview on 10/03/2023 at 10:57 AM, the Speech Language Pathologist (SLP) stated that at the time of her evaluation the patient indicated that the PEG was placed as a precaution and in anticipation of his need for chemo and radiation. The SLP stated at the time of her evaluation the patient was consuming food by mouth. Review of the RN Subsequent Visit dated 08/30/2023 revealed the RN documented the following: that patient manages and cares for the feeding tube in the absence of the SN, there are no family or other nonpaid caregivers involved in the patient’s care, and the patient states he is “unable to manage JT (j-tube) independently due to RUE (right upper extremity) hemiparesis.” During interview on 09/27/2023 at 09:32 AM, the RN Case Manager stated the patient has a PEG tube, not a J-tube, and that she made an error in her documentation. During interview on 09/27/2023 at 09:38 AM, the Clinical Manager stated that the patient has family assistance to help him and that she was under the impression that the niece was his primary support, and the sister was secondary. The Clinical Manager stated that this information was not documented by the RN Case Manager, but that the dietician documented this in a subsequent visit. Review of the Care Coordination Follow Up note dated 08/31/2023 and entered at 11:12 AM revealed the Dietician documented the following: called the patient to schedule but he does not have a feeding pump nor a supply such as a liter bottle, patient was not sure if he could open it, other type is a liter bag but this might be awkward, patient needs a pump and possibly one liter of formula, this would not meet the patient’s entire needs but it would be approximately 2/3, and the patient does not have reliable help. Review of the Care Coordination Follow Up note dated 08/31/2023 and entered at 07:06 PM revealed the Dietician documented the following: patient has an appointment at 11:00 tomorrow which is expected to be the pump and bags for water flushes and if the patient receives pump and education could see him on Saturday. During interview on 10/03/2023 at 01:50 PM, the Dietician 2 stated they knew from the beginning that he could not do the feedings, we knew we needed a pump, so he didn’t have to do the bolus, and that the bottles were too difficult for him. Review of the Client Coordination Note Report dated 09/04/2023 revealed the Dietician documented the following: patient not seen on 09/02/2023 because he had not received an enteral feeding pump, bags for flushing, formula in a liter bottle, and has not gotten supplies he can use with right upper hemiparesis as of Friday. Review of the RN Subsequent Visit dated 09/06/2023 revealed the RN documented the patient has no family of other non-paid caregivers involved in his care and has not received an IV pole or gravity gags for JT feeds. During interview on 09/27/2023 at 09:32 AM, the RN Case Manager stated the patient has a PEG tube, not a J-tube, and that she made an error in her documentation. During interview on 09/27/2023 at 09:40 the Clinical Manager stated this is the part of the documentation that is missing, the conversations had regarding changing the feeds from bolus to gravity pump to make it easier for the patient to administer. Additionally, the Clinical Manager stated that the patient had bolus supplies in his home and that the referring facility had been notified multiple times that tubing was needed, but these conversations are not documented. Review of the Dietician Add On Evaluation dated 09/07/2023 revealed the Dietician documented the following: not tolerating current feeding regimen, has right hemiplegia and can not do feedings yet, lives alone, suppose to get a bag and pole, can not be transitioned from enteral feeds to oral intake, no further nutrition intervention is warranted because long term goals are met, taking oral intake, lives alone, cannot hold PEG tube when putting formula or water by syringe since his right hand does not work properly, and cannot do bolus feedings into the PEG tube with right hemiplegia although he is left handed: needs two hands. During interview on 10/03/2023 at 02:10 PM, the Dietician 2 stated the patient was not transitioning to oral feeds because he was already taking food orally. The Dietician 2 stated that what she documented does not sound correct and that she thinks she was trying to say that if the patient was getting the TF as ordered he would be getting what he needed. Additionally, the Dietician 2 stated as far as the tube feed goes, she asked the patient if he could get anyone to help him and he could not. The Dietician 2 stated that she talked with the dietician at the referring facility to figure out what would work, and she also spoke with the Occupational Therapist to see what was available. Lastly, the Dietician 2 stated we thought we had it figured out, but somewhere along the way someone changed their plan. Based on the documented inconsistencies, it is unclear if the patient could mange his tube feeds in the absence of the SN, if there was an available family member or caregiver available to help him in the absence of the SN, and if the necessary supplies were ever obtained. The agency failed to ensure all clinical notes are complete and accurate as evidenced by the following: Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. Review of the Physician Order dated 09/12/2022 revealed the order for the “Skilled Nurse to perform/teach patient/caregiver wound care pressure injury to unstageable L (left) heel: cleanse wound with wound cleanser and gauze, apply Nickle thick Santyl to wound bed cover with DCD (dry clean dressing) may apply skin barrier to periwound prn (as needed) to prevent maceration and protect periwound wrap with gauze wrap secure with tape change dressing daily and PRN for soiled/dislodged…patient’s sister and daughter to change on non nursing days… Goal: patient/caregiver will verbalize understanding &demonstrate compliance with wound care as evidenced by decrease in size & drainage throughout cert period.” A.) Review of the RN (Registered Nurse) Subsequent Visit dated 09/12/2022 revealed the RN documented “provided/instructed patient/caregiver on pressure ulcer care…details: instructed on care of wound.” Under goals met, the RN documented “Patient verbalized tolerance to wound care. Patient/caregiver verbalized/gave return demonstration of wound care as applicable.” The clinical note does not state who (the daughter or sister) the caregiver is that was instructed on wound care and demonstrated the ability to provide the wound care. During interview on 09/26/2023 at 02:47 PM the Clinical Manager stated that the clinical record does not state which caregiver was taught and redemonstrated wound care. B.) Review of the SN Subsequent Visit dated 09/21/2022 revealed the SN (Skilled Nurse) documented under wound care, that an updated wound care order was received on 09/12/2022. Under interventions, the SN documented “Provided/instructed patient/caregiver on pressure ulcer care.” Under goals met, the SN documented “Patient/caregiver verbalizes/gives returns demonstration of wound care as applicable.” The note does not state who was provided with wound education and returned demonstration. During interview on 09/26/2023 at 03:05 PM the Clinical Manager stated that the note does not state which caregiver was taught and redemonstrated wound care. C.) Review of the SN Subsequent Visit dated 10/03/2022 revealed the SN (Skilled Nurse) documented under the nutritional assessment that the patient is a tube feed and receives Vital 1.5, four times a day. There is no documentation that the patient receives food and fluids orally. Under Interventions provided, the SN documented “Instructed on appropriate food/fluid intake encouraging small frequent meals, timing of meals and controlling stress before/during meals. Details/comments: collecting/documenting food/fluid intake for 24 hour period small frequent meals and eating slowly.” Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the order for “Enteral feeding/care and teaching; Skilled Nurse to perform and instruct in management of gastrostomy including care of site…type bolus type Vital 1.5 4 cans 4X per day frequency flush gastrostomy with 240 cc of water frequency 4 X daily.” There is no order to collect food or fluid intake for 24 hours or for the patient to take small frequent meals by mouth. During interview on 09/26/2023 at 03:06 PM the Clinical Manager stated that she could not state whether the patient was taking food/fluids by mouth. The Clinical Manager stated that there was no order for intakes or outputs, and that the intervention should not have been chosen. Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. I. The agency failed to ensure pain assessments are consistent and accurately reflect the patient’s current status as evidenced by the following: Review of the Home Health Certification and Plan of Care for certification period 11/12/2022 to 01/10/2023 revealed the patient’s medication orders included: Aleve 220 mg tablet, 1 tablet two times daily PRN (as needed) for pain, and Tylenol Extra Strength 500 mg tablet, 1 tablet two times a daily PRN for pain. Review of the Add On Discipline Physician Order dated 01/05/2023 revealed orders for the following: -Skilled Nurse (SN) to assess, evaluate and develop an individualized plan of care. -Skilled Nurse to review medications for interactions, effectiveness of drug therapy…may instruct and reinforce medication teaching related to the use of medications. Dosage, frequency, purpose… -Skilled nurse to observe, assess and provide education on pain management techniques. Review of the RN-Add-On Evaluation dated 01/05/2023 revealed the Registered Nurse (RN) documented under the Vital Signs that the patient’s pain was rated “0” out of 10 (0 is no pain at all and 10 is the worst pain experienced). In the pain assessment, the RN documented the patents PainAd Score (PAINAD is a scale that measures pain behavior in older adults who have dementia or other cognitive impairment and are unable to communicate their pain) was “3” mild pain. Additionally, the patient vocalized an occasional moan/groan, and low level speech with a negative or disapproving quality, facial grimacing, but a relaxed body language. Review of the RN Recert Add-On Evaluation dated 01/09/2023 revealed the RN documented the patients pain under the Vital Signs as “2.” In the pain assessment the RN documented the PainAd score of 3. Additionally, the patient denied pain when asked, but showed non-verbal signs of pain on toes during wound care. The RN documented that the caregiver was present for the visit and was instructed on pain management; specifically, “taking medications as prescribed while pain is still tolerable.” There is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the Home Health Certification and Plan of Care for certification period 01/11/2023 to 03/11/2023 revealed the patient’s medication orders included: Aleve 220 mg tablet, 1 tablet two times daily PRN (as needed) for pain, and Tylenol Extra Strength 500 mg tablet, 1 tablet two times a daily PRN for pain. Additionally, the Skilled Nurse (SN)is to assess, evaluate and develop an individualized plan of care, review medications for interactions, effectiveness of drug therapy…may instruct and reinforce medication teaching related to the use of medications. Dosage, frequency, purpose, and to observe, assess and provide education on pain management techniques. Review of the RN Recert Add-On Evaluation dated 01/20/2023 revealed the RN documented the patients pain under the Vital Signs as 0. In the pain assessment the RN documented the PainAd score of 3. The patient had pain with wound care and the RN instructed the caregiver on pain management. There is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the SN Subsequent Visit dated 01/23/2023 revealed the RN documented the patients pain under the Vital Signs as 3. In the pain assessment the RN documented the PainAd score of 5. The patient had pain with wound care, and the RN instructed the caregivers to “continue with pain management measures. There is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the SN Subsequent Visit dated 01/26/2023 revealed the RN documented the patients pain under the Vital Signs as 4. In the pain assessment the RN documented the PainAd score of 5. The patient had pain with wound care, displayed occasional labored breathing with short periods of hyperventilation with sad, frightened and frowned facial expressions noted. The RN documented that the patient had a open area on the left second toe that “has gotten larger,” and that the patient verbally expressed pain during treatment when the toes were touched. The RN contacted the physician’s office to update the physician on the second toe area and the left great toe, which was “blackened with no change in size or appearance. Additionally, the RN asked whether a virtual visit could be done so that the physician could see the wounds. There is no documentation that the RN notified the physician about the patient’s pain. Furthermore, there is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the SN Subsequent Visit dated 01/30/2023 revealed the RN documented the patients pain under the Vital Signs as 4. In the pain assessment the RN documented the PainAd score of 1. The patient complained of pain during wound care when toes are touched, and the pain decreased when the treatment was finished. There is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the SN Subsequent Visit dated 02/06/2023 revealed the RN documented the patients pain under the Vital Signs as 4. In the pain assessment the RN documented the PainAd score of 6. The patient showed signs and symptoms of pain during wound care but is unable to verbalize pain number amount. There is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the SN Subsequent Visit dated 02/09/2023 revealed the RN documented the patients pain under the Vital Signs as 4. In the pain assessment the RN documented the PainAd score of 4. The patient had pain with wound care, and tolerated wound care “fair.” The RN instructed the patient’s daughter to notify the physician if the patient’s pain increases, to medicate for pain when noted, to inform the physician if pain is not managed by current measures. There is no documentation about the type of pain medication the patient has in place; the frequency in which the patient displays pain, whether the caregiver was administering pain medication, how often, which medication was administered; whether the medication was effective or whether there was a knowledge deficit on the part of the caregiver requiring further education on pain management. Review of the SN Subsequent Visit dated 02/13/2023 revealed the RN documented the patients pain under the Vital Signs as 5. In the pain assessment the RN documented the PainAd score of 6. The RN documented that the patient was unable to say how much pain there is, but the patient was grimacing and moaning during wound care. Additionally, the patient’s caregiver reported that she gives the patient Aleve at night and Tylenol during the day for pain management with relief for a few hours. There is no documentation that the RN inquired about the timing or duration of pain, whether it is constant or episodic, the nature of the pain, location of the pain, what exacerbates the pain, how the pain affects the patient’s well-being, if it interferes with sleep and rest, the actual or approximate times the caregiver administers pain medication, whether the caregiver is administering pain medication before the pain exacerbates, whether the physician was notified that the current pain regimen may be ineffective. Review of the SN Subsequent Visit dated 02/16/2023 revealed the RN documented the patients pain under the Vital Signs as 0. In the pain assessment the RN documented the PainAd score of 6. The RN documented that the patient shows non-verbal signs and symptoms of pain when wound care is done and the patient’s daughter reported that the patient has pain sometimes in her feet. The RN “instructed daughter on pain management measures and to notify MD or SN if pain increasing or not relieved by current measures.” There is no documentation about the type of pain medication the patient has in place; whether the caregiver was administering pain medication, how often, which medication was administered; or whether the medication was effective. Review of the SN Subsequent Visit dated 02/20/2023 revealed the RN documented the patients pain under the Vital Signs as 0. In the pain assessment the RN documented the PainAd score of 5. The RN documented that the patient shows non-verbal signs of pain with wound care, unable to say number amount. The RN instructed the patient’s daughter to provide Aleve or Tylenol for pain, and the daughter reported that she does. There is no documentation that the RN inquired about the timing or duration of pain, whether it is constant or episodic, the nature of the pain, location of the pain, what exacerbates the pain, how the pain affects the patient’s well-being, if it interferes with sleep and rest, the actual or approximate times the caregiver administers pain medication, whether the caregiver is administering pain medication before the pain exacerbates, whether the physician was notified that the current pain regimen may be ineffective. Review of the SN Subsequent Visit dated 02/20/2023 revealed the RN documented the patients pain under the Vital Signs as 0. In the pain assessment the RN documented the PainAd score of 5. The RN documented the patient complained of pain during wound care. There is no documentation about the type of pain medication the patient has in place; whether the caregiver was administering pain medication, how often, which medication was administered; or whether the medication was effective. Review of the SN Subsequent Visit dated 02/27/2023 revealed the RN documented the patients pain under the Vital Signs as 4. In the pain assessment the RN documented the PainAd score of 5. The RN documented the patient was moaning, sighing and guarded during wound care. Additionally, the patient’s daughter was instructed on pain management techniques and measures, and the daughter verbalized “medicates patient when needed.” It is unknown what pain management techniques and measures were discussed. There is no documentation that the RN inquired about the timing or duration of pain, whether it is constant or episodic, the nature of the pain, location of the pain, what exacerbates the pain, how the pain affects the patient’s well-being, if it interferes with sleep and rest, the actual or approximate times the caregiver administers pain medication, whether the caregiver is administering pain medication before the pain exacerbates, whether the physician was notified that the current pain regimen may be ineffective. Review of the SN Subsequent Visit dated 03/02/2023 revealed the RN documented the patients pain under the Vital Signs as 3. In the pain assessment the RN documented the PainAd score of 5. There is no documentation about the type of pain medication the patient has in place; whether the caregiver was administering pain medication, how often, which medication was administered; or whether the medication was effective. Review of the SN Subsequent Visit dated 03/02/2023 revealed the RN documented the patients pain under the Vital Signs as 0. On this visit the RN assessed the patient’s pain using the Wong Baker (Faces) Scale (a pain rating scale that allows a person to self-assess and communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate “no hurt” to a crying face at 10 to indicate “hurts worst”). In the pain assessment, the RN documented that the patient reported no pain within the last 5 days. Under the wound assessment, the RN documented that the patient had pain with wound care, and the RN documented in the narrative note that the patient complained of pain during wound care, which was relieved when wound care was completed.” The documentation is inconsistent. Review of the RN Recert with Skill dated 03/09/2023 revealed the RN documented the patient’s pain under the Vital Signs as 4. In the pain assessment the RN documented the PainAd score of 5. The RN further documented that the patient shows non-verbal signs of pain during wound care, relieved with rest after wound care completed. Daughter gives Aleve or Tylenol for pain PRN with effect per daughter. Review of the Home Health Certification and Plan of Care for certification period 03/12/2023 to 05/10/2023 revealed the patient’s medication orders included: Aleve 220 mg tablet, 1 tablet two times daily PRN (as needed) for pain, and Tylenol Extra Strength 500 mg tablet, 1 tablet two times a daily PRN for pain. Additionally, the Skilled Nurse (SN) is to assess, evaluate and develop an individualized plan of care, review medications for interactions, effectiveness of drug therapy…may instruct and reinforce medication teaching related to the use of medications. Dosage, frequency, purpose, and to observe, assess and provide education on pain management techniques. Review of the SN Subsequent Visit dated 03/13/2023 revealed the RN documented the patient’s pain under the Vital Signs as 5. In the pain assessment the RN documented the PainAd score of 5. In the narrative note the RN documented that the daughter was instructed on pain management and says she does give patient medication for pain when she sees signs of pain or patient says something is hurting. There is no documentation as to what was discussed with the patient’s daughter regarding the patient’s pain and pain management. Review of the SN Subsequent Visit dated 03/20/2023 revealed the RN documented the patient’s pain under the Vital Signs as 5. In the pain assessment the RN documented the PainAd score of 6, and the patient had pain with wound care. Review of the SN Subsequent Visit dated 03/23/2023 revealed the Licensed Practical Nurse (LPN) documented the patient’s pain under the Vital Signs as 0. In the pain assessment the LPN documented the numeric pain scale 0 to 10 was used, and the patient reported no pain in the past 5 days. Under the wound assessment, the LPN documented the patient had pain with wound care. Review of the SN Subsequent Visit dated 03/27/2023 revealed the Licensed Practical Nurse (LPN) documented the patient’s pain under the Vital Signs as 2. In the pain assessment the LPN documented the numeric pain scale 0 to 10 was used, and the patient reported no pain in the past 5 days. Under the wound assessment, the LPN documented the patient had pain with wound care. Additionally, the LPN documented “pain when touching wound site. States it is tolerable. Patient having pain at night and removed dressing on right foot in sleep.” Review of the SN Subsequent Visit dated 03/27/2023 revealed the Licensed Practical Nurse (LPN) documented the patient’s pain under the Vital Signs as 0. In the pain assessment the LPN documented the numeric pain scale 0 to 10 was used, and the patient reported no pain in the past 5 days. Under the wound assessment, the LPN documented the patient had pain with wound care. Review of the SN Subsequent Visit dated 03/30/2023 revealed the Licensed Practical Nurse (LPN) documented the patient’s pain under the Vital Signs as 0. In the pain assessment the LPN documented the numeric pain scale 0 to 10 was used, and the patient reported no pain in the past 5 days. Under the wound assessment, the LPN documented the patient had pain with wound care. In the narrative note the LPN documented “No complaints of pain at this time.” Review of the SN Subsequent Visit dated 04/03/2023 revealed the Licensed Practical Nurse (LPN) documented the patient’s pain under the Vital Signs as 0. In the pain assessment the LPN documented the numeric pain scale 0 to 10 was used, and the patient reported no pain in the past 5 days. Under the wound assessment, the LPN documented the patient had pain with wound care. Review of the SN Subsequent Visit dated 04/07/2023 revealed the RN documented the patient’s pain under the Vital Signs as 3. In the pain assessment the RN documented the numeric pain scale 0 to 10 was used, and the patient reported no pain in the past 5 days. During interview on 09/28/2023 at 09:38 AM the RN (Employee M) stated that she could recall why the pain ratings are different, but that “normally I would agree they should be the same.” At 11:02 AM the RN stated that in the pain area of the electronic record, there is an area to document whether the patient is being medicated and how long it lasts, but the RN did not have the note in front of her to further comment. At 11:16 AM when asked whether the patient’s caregivers were asked about the patient’s pain, frequency/intensity/triggers and what was done to alleviate pain and the effectiveness of the interventions, the RN stated that she could not recall, but she instructed the caregivers on medications for pain and to give the medications when there were signs and symptoms of pain or when the patient expressed pain. When asked what was discussed with the physician regarding the patient’s pain or need to change the plan of care, the RN stated that she did not recall, but that on 02/09/2023 she instructed the patient’s daughter to inform the physician if pain increases and the pain is not managed by current measures. During interview on 09/28/2023 at 11:03 AM the Clinical Manager stated that she would have to find out and provide further information but was not sure if the electronic record prompts the clinician to document whether the patient is being medicated or how long the pain medication lasts. The Clinical Manager stated that if there are any other details about the pain that are not included in the assessment portion of the electronic record, then the clinician could free text it. At 11:16 AM the Clinical Manager stated that the patient’s pain history should be part of the pain assessment. At 11:28 AM the Clinical Manager stated that there is a patient specific order for the physician to be notified is the pain rating exceeds 7/10. During interview on 09/28/2023 at 11:30 AM the Area Vice President of Operations (AVPO) stated that the agency would expect that the clinician educate on how to manage pain in order to not get to a level of intolerance. II. The agency failed to ensure clinical records contain information that accurately reflect the patient’s status as evidenced by the following: Review of the agency’s Guide for Measuring Wounds, revised 07/2019, revealed “To conform to specific instructions provided by the WAT (Wound Assessment Tool) in HCHB, the [agency name] policy on measuring (WC-001) was updated July 1st, 2016. As per the WAT instructions, the updated policy will change the method for how wounds will be measured to the following: Length is measured by placing the measuring device at the longest length of the wound. Width is measured by placing the measuring device side to side at the greatest width perpendicular to the length. is measured by inserting a cotton-tipped applicator at the deepest point in the wound. Hold the cotton tipped applicator with thumb and index finger to mark the depth and hold against a measuring device to determine the depth. For open wounds with shallow un-measureable depth, indicate by 0.1 cm. Tunnels and undermining are documented according to the face of a clock with 12 o’clock being toward the head and 6 o’clock being toward the toes. Example: 6cm tunnel at 4 o’clock. 3cm undermining from 1 o’clock to 7 o’clock. All wound measurements will be measured in centimeters (cm) and per Medicare Guidance measurements, should be rounded to the nearest tenth of a centimeter. Measure wounds at a minimum frequency of once each calendar week (usually the first visit of the week). Note: when the ordered frequency is less than weekly, the wound is measured on each visit. There are multiple ways to measure a wound. There is no clear method of measuring that is more appropriate than others. Consistency in measuring across the board yields the best results… With chronic untreated venous stasis disease and some other disease processes, you will sometimes have multiple open, weepy areas encompassing the entire circumference of the leg. It would be literally impossible to document the location and the precise measurement of every lesion. Do your best to write a thorough description of what you are seeing. Remember, a picture paints a thousand words, photos are essential on these types of wounds.” Review of the Wound Assessment Tool Reports from 01/05/2023 to 05/08/2023 revealed the following: A.) Wound #1 located on the patient’s left great toe (frostbite) measurements: -On 01/05/2023 the RN documented the wound was measured as 8.5 cm length (l) x 4.5 cm width (w) x 0.1 cm depth (d). -On 01/09/2023 the RN documented the wound measured 8.5 cm x 4.5 cm x 0.1 cm. -On 01/18/2023 the RN documented the patient’s wound measured 8 cm x 4.5 cm x 0.1 cm. -On 01/23/2023 the RN documented the patient’s wound measured 8 cm x 4.5 cm x 0 cm. -On 01/30/2023 the RN documented the patient’s wound measured 8 cm x 4.5 cm x 0.1 cm. -On 02/06/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 02/13/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 02/20/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0 cm. -On 02/27/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0 cm. -On 03/06/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 03/09/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 03/13/2023 the RN documented the patient’s wound measured 8 cm x 4 cm x 0.1 cm. -On 03/20/2023 the RN documented the patient’s wound measured 8 cm x 4 cm x 0.1 cm. Review of the RN Add-On Evaluation dated 01/05/2023 revealed the RN obtained photographs of the patient’s left great toe and foot. Review of the photograph revealed a wound measurement tape was placed on the anterior medial aspect of the patient’s foot. The anterior medial aspect of the patient’s foot measured side to side (width) was approximately 7.5 cm. Based on the photograph, the patient’s great toe is proportionate in size to the foot. B.) Wound #2 located on the right great toe (frostbite) measurements: -On 01/05/2023 the RN documented the wound was measured as 10 cm length (l) x 1 cm width (w) x 0.2 cm depth (d). -On 01/09/2023 the RN documented the wound measured 10 cm x 1 cm x 0.2 cm. -On 01/18/2023 the RN documented the patient’s wound measured 10 cm x 1 cm x 0.1 cm. -On 01/23/2023 the RN documented the patient’s wound measured 6 cm x 1 cm x 0.1 cm. -On 01/30/2023 the RN documented the patient’s wound measured 5.5 cm x 1 cm x 0.1 cm. -On 02/06/2023 the RN documented the patient’s wound measured 5 cm x 2 cm x 0.1 cm. -On 02/13/2023 the RN documented the patient’s wound measured 2.5 cm x 2.5 cm x 0.1 cm. -On 02/20/2023 the RN documented the patient’s wound measured 2.9 cm x 2.5 cm x 0.1 cm. -On 02/27/2023 the RN documented the patient’s wound measured 3 cm x 2.2 cm x 0.1 cm. -On 03/06/2023 the RN documented the patient’s wound measured 3 cm x 2 cm x 0.1 cm. -On 03/09/2023 the RN documented the patient’s wound measured 3 cm x 2 cm x 0.1 cm. -On 03/13/2023 the RN documented the patient’s wound measured 3 cm x 2 cm x 0.1 cm. -On 03/20/2023 the RN documented the patient’s wound measured 2 cm x 2 cm x 0.1 cm. -On 04/26/2023 the Skilled Nurse (SN) documented the patient’s wound measured 5 cm x 0.4 cm x 0.1 cm. Review of the RN Add-On Evaluation dated 01/05/2023 revealed the RN obtained a photograph of the patient’s right great toe and foot. Review of the photograph revealed a wound measurement tape was placed on the anterior medial aspect of the patient’s foot. The anterior medial aspect of the patient’s foot measured side to side (width) was approximately 7 to 7.5 cm. Review of the photograph revealed the patient’s great toe is proportionate in size to the foot. During interview on 09/28/2023 beginning at 09:41 AM the RN initially stated that she measured length x width x depth, and that the patient’s entire toes were necrotic. The RN then stated that the RN believed the measurement was front to back and “I think I was saying front on necrotic.” The RN stated that she measured the front, around to the back of the toe and not just top to bottom. During interview on 09/28/2023 beginning at 09:43 the Clinical Manager stated that the agency’s policy for wound measurement states to measure the longest point of the wound in any direction. During interview on 09/28/2023 at 09:51 AM the Area Vice President of Operations (AVPO) stated the agency’s wound guidance states that length is a measured at the largest length of the wound and width is perpendicular. The AVPO added that there are multiple ways to measure a wound, but consistency yields the best results, and the wound measurements were consistent. III. The clinical record is incomplete as evidenced by the following: A.) Review of the Home Health Certification and Plan of Care for certification period 01/11/2023 to 03/11/2023 revealed the Skilled Nurse is to “cleanse wound R (right) great toe with wound cleanser, apply Silvadene to toe, cover with gauze, secure with tape, 3 x weekly and PRN (as needed) dressing dislodgement…Skilled Nurse to cleanse L (left) great toe with wound cleanser, apply Silvadene to toe, cover with gauze, secure with tape 3 x weekly and PRN dressing dislodgement. Caregiver will perform wound care when SN not present.” Review of the 01/18/2023 SN Subsequent Visit revealed the RN documented “R great toe measuring 3.5 cm x 1 cm scabbed other area draining small amount L great toe continues to have soft black eschar with very scant drainage. Instructed caregivers, dtr (daughter) [name] and granddaughter [name] to give medication for pain if patient c/o (complains of) pain…TC (telephone call) to Dr. [name] office and left message re [regarding] need for MD consult, left phone number for return call.” There is no documentation that the physician returned the call. Review of the Coordination Note dated 01/18/2023 at 09:30 AM revealed the RN documented “R great toe measuring 3.5 cm x 1 cm scabbed other area draining small amount L great toe continues to have soft black eschar with very scant drainage. Instructed caregivers, dtr (daughter) [name] and granddaughter [name] to give medication for pain if patient c/o (complains of) pain…TC (telephone call) to Dr. [name] office and left message re [regarding] need for MD consult, left phone number for return call.” There is no documentation that the physician returned the call. Review of the Clinical Notes from 01/18/2023 to 01/21/2023 revealed there is no Clinical Note documented regarding the physician returning the RN’s call and no documented evidence of any discussion or coordination of care with the physician or individuals involved in the patient’s care. Review of the SN Subsequent Visit dated 01/20/2023 revealed the RN documented the in-home time began at 08:53 AM and ended at 09:37 AM. The RN documented that the patient’s granddaughter was present at the visit and “she reports she did speak with Dr. [name] yesterday she was updated on wounds instructed granddtr (granddaughter) on pain management.” The RN documented under interventions provided that the RN instructed the patient/caregiver on wound care, and “performed wound care to: R great toe, L great toe.” Additionally, the “patient/caregiver verbalized/gave return demonstration of wound care.” Under the Wound Assessment the RN documented the wound care provided to the Left great toe as: “SN cleaned wound L great toe with wound cleanser applied Medihoney to wound covered with dry dressing…” The wound care to the right great toe was documented as “SN cleaned wound R great toe with wound cleanser applied Medihoney to wound covered with dry dressing.” There is no documentation in the visit note that the RN spoke with the physician and obtained new orders for wound treatment. Review of the Physician Order dated 01/20/2023 at 08:53 AM revealed orders for the following: -SN to cleanse the wound R great toe with wound cleanser, apply Medihoney to wound cover with dry gauze dressing, secure with tape… -SN to cleanse the wound L great toe with wound cleanser, apply Medihoney to wound cover with dry gauze dressing, secure with tape… Review of the Physicians Orders from 01/20/2023 to 03/11/2023 lack an order to discontinue the Silvadine. It is unclear when the RN spoke with the physician and obtained the wound treatment orders, why the orders were changed and under what circumstances the Medihoney should be used to treat the wounds as opposed to the Silvadene. During interview on 09/28/2023 at 10:18 AM the RN stated “When an order is written, it comes from the physician…I do not recall when I got an order,” and the RN did not know whether there is documentation to explain where the order to change the wound treatments came from or why the treatment was changed. During interview on 09/28/2023 at 10:27 AM the Area Vice President of Operations (AVPO) stated that there is a note that states that the patient’s granddaughter spoke with the physician the day before the visit. The AVPO added that “This was 9 months ago.” The AVPO stated, “We should know what prompted the order.” During interview on 09/28/2023 at 10:30 AM the Clinical Manager stated that there is no documentation to show that the Silvadene was discontinued. There is just an understanding to use the Medihoney. B.) Review of the SN Subsequent Visit dated 01/23/2023 revealed the in-home visit took place from 08:54 AM to 09:29 AM. The RN documented a wound on the left 2nd toe that is slightly reddened and slightly edematous. Under the wound assessment, the RN identified the wound as wound #3- 2nd toe, LT (left) edema, scab. No measurements were taken, and no photographs were taken. The wound had a scant amount of serosanguinous exudate, nonpitting peripheral edema Review of the Physician Order dated 01/23/2023 at 08:54 AM revealed the order for the SN to cleanse wound L 2nd toe with wound cleanser apply Medihoney to wound, cover with dry gauze and secure with tape. It is unclear when the RN spoke with the physician to obtain the verbal order, as there is no documentation that a conversation occurred. Additionally, there is no documentation about possible etiology of the new wound. During interview on 09/28/2023 at 10:40 AM the Clinical Manager stated that there was no documentation in the record about the etiology of the wound. C.) Review of the SN Subsequent Note dated 01/23/2023 revealed the RN documented that wound #2, the right great toe, had a small amount of serosanguinous exudate with no odor and no necrotic tissue. Review of the SN Subsequent Note dated 01/26/2023 revealed the RN documented that there was no change in status of wound #2, the right great toe; however, the wound had a small amount of purulent exudate with a faint odor and yellow necrotic tissue. No measurements were obtained during the visit. The documentation is inconsistent. During interview on 09/28/2023 at 10:45 AM the RN stated that she did not know why the documentation was inconsistent. D.) Review of the SN Subsequent Note dated 01/23/2023 revealed the RN identified wound #3 as a scabbed area located on the left anterior 2nd toe. The wound had a scant amount of serosanguinous exudate, nonpitting peripheral edema Review of the SN Subsequent Note dated 01/26/2023 revealed the RN documented there was no change in the wound status; however, the RN documented that the wound was now open and measured 1.2 cm x 1.1 cm x 0.1 cm, and there was a small amount of purulent exudate with a faint odor. The documentation is inconsistent and does not reflect the patient’s current status. There is evidence of a wound status change. During interview on 09/28/2023 at 10:52 AM the Clinical Manager stated that there was a change in the wound status, and it was documented in the narrative. E.) Review of the SN Subsequent Note dated 02/13/2023 revealed the RN documented under the wound assessment for wound #2, the right great toe, there is no peripheral tissue edema. Review of the SN Subsequent Note dated 02/16/2023/2023 revealed the RN documented under the wound assessment for wound #2, there is peripheral tissue edema, non-pitting >= 4cm. Additionally, the RN documented there is no change in the wound status. The documentation is inconsistent and does not reflect the patient’s current status. There is evidence of a wound status change. During interview on 09/28/2023 at 11:40 AM the Clinical Manager stated that if there is a difference from one visit to the next visit, then it is considered a change in status. She stated that in the previous assessment there was no edema, but now there is. F.) Review of the SN Subsequent Note dated 02/13/2023 revealed the RN documented under the wound assessment for wound #3, the left 2nd toe, there is no peripheral tissue edema. Review of the SN Subsequent Note dated 02/16/2023/2023 revealed the RN documented under the wound assessment for wound #3, there is peripheral tissue edema, non-pitting >= 4cm. Additionally, the RN documented there is no change in the wound status. The documentation is inconsistent and does not reflect the patient’s current status. There is evidence of a wound status change. During interview on 09/28/2023 at 11:40 AM the Clinical Manager stated that if there is a difference from one visit to the next visit, then it is considered a change in status. She stated that in the previous assessment there was no edema, but now there is. G.) Review of the RN Recert with Skill dated 03/09/2023 revealed the RN under the wound assessment for the left great toe that wound care was performed , there was no change in the wound status, the wound measured 8 cm x 4.2 cm x 0.1 cm, the wound is necrotic and the patient had pain with wound care. The SN cleansed the wound with cleanser, applied Medihoney, covered it with dry gauze dressing and secured it with tape. The RN documented there was communication with the physician; specifically, “spoke with [individual’s name] at Dr. [name]’s office. Received verbal order for recert.” Under Medication Understanding Changes, the RN documented “Silvadene 1% topical cream, dose: per instructions, purpose: “N”, directions for use: “N”, side effects/interactions: “N”, Med understanding notes: [left blank].” There is no documentation to explain why the RN is documenting about Silvadene. Review of the Home Health Certification and Plan of Care for certification period 03/12/2023 to 05/10/2023 revealed an order for the SN to cleanse the wound to the left great toe with wound cleanser, apply Silvadene to wound, cover with dry gauze dressing and secure with tape 3 x weekly and PRN for dressing dislodgement. There is a lack of documentation to explain why the treatment for the wound was changed from Medihoney to Silvadene. During interview on 09/28/2023 at 12:20 PM the RN stated that it was difficult for the RN to recall why the change was made. During interview on 09/28/2023 at 12:21 PM the Clinical Manager stated that there is no documentation in the record to explain why there was a change from Medihoney to Silvadene. H.) Review of the RN Visit + SUP revealed the RN documented in the wound assessment that for wound #2, right great toe, that Medihoney was applied to the wound. For wound #3, the left anterior 2nd toe, Medihoney was applied to the wound. In the narrative note, the RN documented “SN visit for wound care to bilat (bilateral) toe wounds. Drsgs (dressings) removed, wounds cleansed with wound cleanser, Silvadene cream applied followed by 4 x 4 drsg, Kerlix and tape.” The documentation is inconsistent. It is unclear what treatment was completed. During interview on 09/27/2023 at 10:35 AM the RN stated that Silvadene was applied to the left great toe, as she recalled. She stated that she followed the orders for wound care but can’t recall exactly. During interview on 09/27/2023 at 10:36 AM the Clinical Manager stated there are inconsistencies between the narrative and the wound care provided. The agency failed to ensure assessments are complete, consistent and accurately reflect the patient’s current status as evidenced by the following: Patient #12- This 80 year old patient with diagnoses that include Encounter for orthopedic aftercare following surgical amputation, Type II Diabetes, and personal history of diabetic foot ulcer was admitted to the agency on 06/25/2023. This patient resides in an Assisted Living facility. A.) Review of the Home Health Certification and Plan of Care for certification period 06/25/2023 to 08/23/2023 revealed the Skilled Nurse is to assess, evaluate and develop an individualized plan of care, to assess/ evaluate co-morbid conditions and any new conditions that present themselves during this episode to identify changes and intervene to minimize complications. Under goals/rehabilitation potential/discharge plans, “Patient’s blood sugar will remain well controlled throughout episode of care and patient will not have any signs of skin breakdown or complications. Review of the RN OASIS Assessment dated 06/25/2023 revealed the Registered Nurse (RN) documented under the endocrine/hemapoietic assessment that the patient has a diagnosis of diabetes, the diabetes is managed with an oral antidiabetic, blood sugars are checked daily, the range of the patient’s usual blood sugar reading is “60 – 400,” and there are no abnormal endocrine/hematopoietic findings. There is no documentation of the patient’s blood sugar for that date to establish a baseline at the start of care. During interview on 09/27/2023 at 10:06 AM the RN stated that she does not look at the patient’s glucometer, and she considers a blood sugar range of 60 to 400 to be a normal range for patients who have diabetes. The RN stated that she did not obtain a blood sugar on that date, and “usually we ask the patient how their sugars range and they let us know.” The documentation is incomplete and does not include a blood sugar reading for the date of the assessment. During interview on 09/28/2023 at 10:18 AM the Clinical Manager stated that she did not believe there are orders on the plan of care for the Skilled Nurse (SN) to assess the diabetes. B.) Review of the RN OASIS Assessment dated 06/25/2023 revealed the Registered Nurse (RN) documented under the Genitourinary assessment, “No abnormal findings in the genitourinary assessment…indicate any genitourinary catheters, ostomies or tubes: None of the above…Urinary incontinence or urinary catheter presence: patient requires a urinary catheter.” There is no documentation of the size of the catheter, amount of balloon inflation, or when it was placed. Review of the Home Health Certification and Plan of Care for certification period 06/25/2023 to 08/23/2023 revealed the Skilled Nurse is to perform insertion of 16 Fr (French) indwelling catheter, instill 10 cc of normal saline or sterile water into balloon, secure tubing with appropriate securement device, change every month and PRN (as needed) for leakage, blockage, dislodgement or malfunction. The documentation is incomplete and does not include the size of the patient’s foley, the amount of balloon inflation, or the date it was last placed. During interview on 09/28/2023 at 10:19 AM the Clinical Manager stated that there is no documentation of when the catheter was placed. During interview on 09/28/2023 at 10:20 AM the RN stated that the catheter should be changed one time a month per protocol, and the RN would change it one month from the date the case was opened. C.) Review of the SN Subsequent Visit dated 08/10/2023 revealed the RN documented “SN visit for new wound right plantar foot. Client is alert and forgetful…new diabetic ulcer right plantar foot #8 0.8 x 0.6 x 0.2 with small amount of serosanguinous drainage.” Under the wound assessment the RN identifies the same wound as wound #9: “Mid Prox plantar, Rt (right), Diab (diabetic) Ulcer.” The documentation is inconsistent. During interview on 09/27/2023 at 03:17 PM the RN stated that she documented the wrong wound number, and that the correct number for the wound is #9. Patient #6- This 64 year old patient with diagnoses that include Ataxia following cerebral infarction, chronic atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the agency on 06/09/2023. This patient is receiving therapy only services. The agency failed to ensure documentation is complete and consistent with the patient’s current status as evidenced by the following: A.) Review of the PT (Physical Therapy) Routine Visit dated 06/26/2023 revealed the PT documented the following under integumentary: “No abnormal findings in integumentary assessment…abrasion top of right foot.” Under interventions provided, the PT documented “Clinician observed for signs and symptoms of hypo and hyperglycemia and assessed feet: Details/comments: Does not test blood sugar intact skin B (both) feet.” There is no documentation regarding how the abrasion of the right foot occurred, or evidence the PT asked about the etiology of the abrasion. Additionally, there is no evidence the PT was made aware of the abrasion by the Certified Occupational Therapist (COTA) that identified the abrasion on 06/23/2023. During interview on 09/29/2023 at 01:22 PM the Director of Operations stated that there is nothing in the record about the PT exploring the etiology of the abrasion, or the PT being informed about the abrasion by the COTA. Review of the Hospital Hold Physician Order dated 07/01/2023 revealed the order “Patient admitted to [hospital] with a fib on 06/27/2023.” Review of the PT Resumption of Care dated 07/27/2023 revealed the PT services were being resumed because the patient had a recent hospitalization for UTI (urinary tract infection)/Sepsis and subacute rehabilitation admission. During interview on 09/29/2023 at 01:28 PM the Area Vice President of Clinical stated that the PT should have elaborated and talked about the abnormal skin in the documentation. B.) Review of the agency policy entitled “Pain Assessment and Management” last reviewed 03/07/2023 revealed “ Many patients experience pain classified as acute or chronic. Acute pain such as post-operative pain or injuries related to falls or other actions subsides as healing takes place…Specific diseases or complications of illness may impair the patient’s ability to define or report pain. Use very specific questions and use visual facial descriptions of pain for clarification…the physician should be notified when there are new complaints of pain or when prescribed interventions do not result in adequate pain relief.” Review of the PT (Physical Therapy) Routine Visit dated 06/26/2023 revealed the PT documented under Vital Signs that the patient’s pain rated 3 out of 10. Under the pain assessment, the PT documented “no” to the question, “Does the patient report pain within the last 5 days?” Under Therapy Subjective, the PT documented that the patient has “inconsistent unreliable answers.” It is unknown what the patient’s pain level was, where the pain was located, when it started, what triggers the pain, what the pain characteristics are, whether the pain is distressing to the patient, and what non-pharmacologic interventions alleviate the pain. Review of the Home Health Certification and Plan of Care for certification period 08/08/2023 to 10/06/2023 revealed there is no order for pain medication for this patient. During interview on 09/29/2023 at 01:30 PM the Clinical Manager stated that the information should not be inconsistent. When asked whether the PT explored the patient’s complaint of pain further, since the report of pain was a new finding, the Clinical Manager stated that she did not see any documentation to indicate the PT did so. During interview on 09/29/2023 at 01:31 PM the Area Vice President of Clinical stated that it is the agency’s expectation to report new findings to the physician and ask for recommendations. C.) Review of the PT OASIS Admission revealed the patient’s height is documented as 70 inches. Review of the PT Resumption of Care dated 07/27/2023 revealed the PT documented the patient’s height to be “841” inches. The height is inconsistent with the previous height recorded on the initial assessment. During interview on 09/29/2023 at 01:30 PM the Clinical Manager stated that the height documented on 07/27/2023 has “got to be inaccurate.” D.) Review of the PT Recert with Skill revealed the PT documented that the patient’s skin was intact, and the patient had a small scab on the right 4th digit. There is no further documentation to describe the exact location of the scab (hand or foot). During interview on 09/25/2023 at 10:09 AM the PT stated that the scab would have been on the patient’s toe. Regarding the patient’s skin being intact, the PT stated that if the patient did not have an open wound, then she considers the skin to be intact, “but there was a small scab.” Patient #7 – This 94-year-old patient with diagnoses that include polycythemia vera, pain in right hip, and constipation was admitted to the agency on 05/05/2023. Review of the Home Health Certification and Plan of Care for certification period 05/05/2023 to 07/03/ 2023 revealed an order for licensed professional to report vital signs falling outside the following established parameters. Temp (Temperature) (greater than) 100, Pulse 100 Resp (Respirations) 20, Systolic BP (blood pressure) 180, Diastolic BP 100, and Pain >7. Review of the PT (Physical Therapy) OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 05/05/2023 revealed the Physical Therapist documented the following vital signs: Temperature: 96 Pulse: 91 Respirations: 18 Body Mass Index (%): 19 Height: 62 Pain: 3 Weight (LBS)(pounds): 104 There is a lack of documented evidence of the patient’s blood pressure. The PT failed to prepare clinical and progress notes. During an interview on 09/25/2023 at 12:20 PM, the Physical Therapist (PT) stated that he did not know why the patient’s blood pressure was not documented because he did take a blood pressure on the patient and that he takes blood pressures on all patients. During an interview on 09/25/2023 at 12:21 PM, the Clinical Manager (CM) stated that the clinicians cannot go past the assessment without documenting a blood pressure and that she is not sure what happened. Patient #8 – This 89-year-old patient with diagnoses that include other symptoms and signs with cognitive function following cerebral infarction, vascular dementia, and essential (primary) hypertension was admitted to the agency on 06/28/2023. A. Review of the Home Health Certification and Plan of Care for certification period 08/27/2023 to 10/25/2023 revealed the has a diagnosis of constipation, unspecified. Review of the OT (Occupational Therapy)/OTA (Occupational Therapy Assistant) Visit note dated 08/28/2023, 09/05/2023, and 09/12/2023 revealed the OTA documented no changes in gastrointestinal findings since last visit. The documentation is unclear and does not indicate if the patient is constipated or having regular bowel movements and when the patient’s last bowel movement was. During an interview on 09/27/2023 at 11:36 AM, the OTA stated that in the past there was an option to be able to document when the patient’s last bowel movement was. The OTA continued to state that the patient has regular bowel movements. During an interview on 09/27/2023 at 11:38 AM, the Area Vice President of Clinical stated that she is not sure why the clinician’s ability to document a complete gastrointestinal assessment was taking away from the agency’s software that they use. During an interview on 09/27/2023 at 11:49 AM, the OTA stated that she does ask the patient when their last bowel movement is but doesn’t have the ability to document the patient’s last bowel movement under the gastrointestinal assessment or in a narrative in the patient’s electronic medical record. B. Review of the Home Health Certification and Plan of Care for certification period 08/27/2023 to 10/25/2023 revealed the has a diagnosis of constipation, unspecified. Review of the PT/PTA Subsequent Visit note dated 09/08/2023 revealed the PT documented the following no changes in gastrointestinal findings since last visit. The documentation is unclear and does not indicate if the patient is constipated or having regular bowel movements and when the patient’s last bowel movement was. During an interview on 09/27/2023 at 03:05 PM, the PT stated every time that I am at the patient’s home, I always ask if there are changes with the patient’s bowel movements, signs and symptoms of constipation and the patient’s bowel movement frequency. I honestly don't have the specific answer as to when the patient’s last bowel movement was. Patient #9 – This 82-year-old patient with diagnoses that include encounter for orthopedic aftercare, other acquired deformities of the left foot, and aortic aneurysm of unspecified site, without rupture was admitted to the agency on 08/18/2023. Review of the PT (Physical Therapy) OASIS (Outcome and Assessment Information Set) Admission dated 08/18/2023 revealed the PT documented the following: yes, abnormal findings in gastrointestinal assessment, constipated and last bowel movement was on 08/14/2023. Review of the PT/PTA (Physical Therapy Assistant) Subsequent Visits dated 08/23/2023 and 08/29/2023 revealed the PT documented the following: no changes in gastrointestinal findings since last visit. The documentation is unclear and does not indicate if the patient is constipated or having regular bowel movements and when the patient’s last bowel movement was. During an interview on 09/28/2023 at 03:03 PM, the PT stated that the patient had no abnormalities and that there is a limitation to documentation due to the software the agency uses. During an interview on 09/28/2023 at 03:04 PM, the PT stated that he would indicate that the patient’s constipation has resolved and did not know when the patient last had a bowel movement. HV Patient #10 – This 70-year-old patient with diagnoses that include pressure ulcer of right buttock, stage 4, morbid (severe) obesity with alveolar hypoventilation, and peripheral vascular disease was admitted to the agency on 08/09/2023. A. Review of the RN Subsequent Visit note dated 08/11/2023 revealed the following: Wound Assessment: Low buttock, RT (Right), PU (Pressure Ulcer), Stage IV. Reason Measurements not taken – Not Due. Narrative: Tenderness when pressure measurement of depth. The documentation is unclear as to whether the SN took wound measurements. During an interview on 09/29/2021 at 12:50 PM, the RN stated that she always checks to see if there is depth to the wound and that she may not always get measurements with a ruler. B. Review of the OT Add-On Evaluation Review of the Home Health Certification and Plan of Care for certification period 08/09/2023 to 10/07/2023 revealed the patient’s date of birth as 03/01/1953. Review of the RN OASIS Admission note dated 08/09/2023 revealed the RN documented the following: Narrative: This 71-year-old women who lives on the ground floor appt (unknown abbreviation) returned home Monday from an extensive rehab (rehabilitation) stay. There is inconsistent documentation regarding the patient’s age. During an interview on 09/29/2023 at 03:40 PM, the RN stated that the patient is 70-years-old and agreed that her documentation was a typographical error. C. Review of the OT Add-On Evaluation Review of the Home Health Certification and Plan of Care for certification period 08/09/2023 to 10/07/2023 revealed the patient’s date of birth as 03/01/1953. Review of the OT Add-On Evaluation dated 08/14/2023 revealed the OT documented the following: this is a 71-year-old female resident of a senior apartment. There is inconsistent documentation regarding the patient’s age. During an interview on 09/27/2023 at 12:22 PM, the OT stated that the patient is 70-year-old and that he must have made a typo in his documentation of the patient’s age. D. Review of the Home Health Certification and Plan of Care for certification period 08/09/2023 to 10/07/2023 revealed the following: Occupational Therapist to evaluate for ADLs (Activities of Daily Living). DME and Supplies: Grab bars, shower chair, and walker. Review of the OT Add-On Evaluation dated 08/14/2023 revealed the following: Durable Medical Equipment (DME) Available: bath/shower – grab bars. Indicate other DME recommended: four-wheel walker? wheelchair, lift chair, bath seat, and bath grab bar. During an observational home visit on 09/12/2023 at 10:00 AM, the surveyors observed the following: the patient with her four-wheeled walker greeted the occupational therapist and the surveyors at the door. The documentation is inconsistent/unclear as to why the there is a recommendation for a four-wheeled walker, shower chair and grab bars. During an interview on 09/27/2023 at 12:25 PM, the OT stated that he was not sure, and that recommendation was an oversight, or he added the DME when it was not necessary. The OT continued to state that the recommendation for a shower chair and wheelchair were to maximize the patient’s safety. As of exit, no further information was provided. E. Review of the RN Subsequent Visit note dated 08/21/2023 revealed the RN documented the following: Wound Assessment: #1 Low buttock, RT, PU, Stage IV. Measurements taken: Yes. Length x Width x Depth (CM) (centimeters): 5 x 2 x 4. Review of the RN Subsequent Visit note dated 08/25/2023 revealed the LPN documented the following: Wound Assessment: #1 – Low buttock, RT, PU, Stage IV. Measurements taken: Yes. Length x Width x Depth (CM): 5.5 x 2 x 11.5. This is a 7.5 cm increase to the depth of the wound. There is inconsistent documentation regarding the depth of the wound. During an interview on 09/29/2023 at 03:04 PM, the LPN stated that her documentation of 11.5 cm as the depth the patient’s wound was an error, and that the actual depth was 2 cm. F. Review of the Home Health Certification and Plan of Care for certification period 08/09/2023 to 10/07/2023 revealed an order for skilled nurse to perform/teach patient/caregiver wound care pressure injury to right buttock irrigate cleanse with wound cleanser calcium alginate AG and rolled gauze. May apply skin barrier to peri-wound PRN (as needed) to prevent maceration and protect peri-wound cover with bordered gauze, secure with tape if edges roll, and change dressing three times a week and prn. Review of the Physician Order dated 08/21/2023 the following orders: No change SN frequency, when supplies available, DC (Discontinue) the following wound care and begin the new wound care as follows: DC (Discontinue): Perform/teach patient/caregiver wound care pressure injury to right buttock. Irrigate/cleanse with wound cleanser. Fill cavity with calcium alginate AG (unknown abbreviation) and rolled gauze. May apply skin barrier to peri-wound PRN to prevent maceration and protect peri-wound. Cover with bordered gauze. Secure edges with tape if edges roll. Change dressing three (3) times a week and prn. Begin: Perform/teach patient/caregiver wound care pressure injury to right buttock. Irrigate/cleanse with wound cleanser. Fill with wet to dry Dakin’s rolled gauze. May apply skin barrier to peri-wound PRN to prevent maceration and protect peri-wound. Cover with Abd (abdominal) pad. Secure with tape. SN/caregiver to change dressing three times a week. PT/caregiver may change outer drsg (dressing) is required for displacement/soiling. Goal R (right) buttock WND (unknown abbreviation) to progress toward healing EOC (unknown abbreviation). Review of the RN Subsequent Visit note dated 08/21/2023 revealed the RN documented the following: Alginate dressing changed. Attempted to order Dakin’s SOLN (unknown abbreviation) through medical supply company states Dakin’s is not covered and patient would have to purchase privately. Patient instructed and stated she does not want to purchase Dakin’s and would prefer if doctor would consider another alternative. Msg (unknow abbreviation) that no Dakin’s available, insurance won’t cover, alginate ag dressing changed. No new orders at this time. Review of the LPN Subsequent Visit note dated 08/23/2023 revealed the following: Wound Assessment: #1 – Low buttock, RT, PU Stage IV. Change in Status: None. Wound Assessed: Yes. Wound Care Provided: perform/teach patient/caregiver wound care pressure injury to right buttock. Irrigate/cleanse with wound cleanser. Fill with wet to dry Dakin’s rolled gauze. May apply skin barrier to peri-wound PRN to prevent maceration and protect peri-wound. Cover with Abd pad. Secure with tape change dressing three times a week. PT may change outer dressing if required for displacement/soiling. Goal R buttock WND to progress toward healing EOC. Patient tolerated well. There is unclear/inconsistent documentation as to what wound care was provided. During an interview on 09/29/2023 at 02:59 PM, the LPN stated that she did a wet to dry gauze dressing, cleansed with normal saline and applied an Abd pad. I may not have used the calcium alginate dressing that day and that I don’t really remember. The LPN continued to state that this was one (1) of her first visits, that she receives a phone report from the nurse and looks at prior notes and orders to see what is going on with the patient.

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 review of clinical records, agency policies and procedures and staff interview for four (4) of seventeen (17) clinical records (Patient #s: 1, 2, 5, and 8), the agency failed to ensure there was effective communication and follow-up with the physician involved in the patient’s plan of care. Failure to communicate with the physician involved in the patient's care has the potential for unmet patient needs and negative outcomes. The agency failed to communicate patient findings and needs with the physician as evidenced by the following: Patient #5- This 71-year-old patient with diagnoses that include pressure ulcer of left heel, unstageable; other disorder of the skin, subcutaneous related to radiation, and malignant neoplasm of overlapping sites of other parts mouth was admitted to the agency on 09/06/2022 and discharged on 10/17/2022. This record was reviewed as a potentially avoidable event: discharge to community with unhealed stage 2 pressure ulcer. A.) Review of the RN (Registered Nurse) OASIS Admission dated 09/06/2022 revealed the Skilled Nurse (SN) documented under the cardiovascular assessment that the patient had bilateral lower extremity edema. The right lower extremity edema is characterized as 1+ pitting edema, and the left lower extremity is characterized as 2+ pitting. Review of the narrative note revealed the RN documented that the physician’s office was called via telephone and the RN spoke with someone in the physician’s office and confirmed the patient’s diagnoses. There is no evidence the physician was made aware of the patient’s edema. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed the POC does not include orders, interventions, goals, or measurable outcomes to address the edema identified in the initial assessment of this patient who was admitted with an unstageable pressure ulcer of the left heel. During interview on 09/26/2023 at 02:50 PM the Clinical Manager stated that the SN did not write any interventions or goals for the edema. B.) Review of the RN Subsequent Visits dated 09/12/2022, 09/21/2022 and 10/03/2022 revealed the following: -On 09/12/2022 and 09/21/2022 the SN documented under the cardiovascular assessment that the patient had bilateral lower extremity edema. The right lower extremity edema is characterized as 1+ pitting edema, and the left lower extremity is characterized as 2+ pitting. There is no documentation that the RN notified the patient’s physician about the edema or obtained instructions or orders to address the edema. -On 10/03/2022 the SN documented under the cardiovascular assessment that the patient had bilateral lower extremity edema. The right lower extremity edema is characterized as 1+ pitting edema, and the left lower extremity is characterized as 1+ pitting. There is no documentation that the RN notified the patient’s physician about the edema or obtained instructions or orders to address the edema. Review of the Home Health Certification and Plan of Care for certification period 09/06/2022 to 11/04/2022 revealed an order for the SN to assess, evaluate and develop an individualized plan of care. The POC does not include interventions, goals, or measurable outcomes to address the edema. During interview on 09/26/2023 at 02:50 PM the Clinical Manager stated that the SN did not write any interventions or goals for the edema. The Clinical Manager stated that the clinical record does not show that the physician was made aware of the edema, but the SN should have contacted the physician for goals, interventions, or orders that the physician wanted in place. Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. Review of the agency policy entitled “Digital Wound Photography” last revised 05/11/2023 revealed “It is suggested, digital photography of wounds is completed: - At start of care - Minimum of monthly - At recertification - Any time there is a change in the wound, positive or negative, at the discretion of the clinician, request of the MD or wound care specialist. Photos should be downloaded per Manufacturer's Device Instructions and emailed to the person designated to receive photos for the care center. Print a copy of the photo for the physician unless the physician or patient has refused or requested not to receive photos.” Review of the SN Subsequent Visit dated 01/26/2023 revealed the RN documented that she contacted the patient’s physician’s office and spoke with an employee at the office. The RN documented “informed her [employee at physician’s office] to update MD (physician) that patient has 2nd L (left) toe open area that was previously scabbed, L great toe blackened with no change in size or appearance. She took information to update MD asked if MD can do virtual visit with grandtr (granddaughter) to see wounds, she took info to give MD. She did give me office email to send wound photos if able to be done by my office.” Review of the Clinical Notes from 01/26/2023 to 05/08/2023 (date the patient was discharged from the agency) lacked documentation that the RN followed up with the physician regarding a visual meeting or evidence that the RN printed a copy of the wound photographs to send to the physician. During interview on 09/28/2023 at 10:46 AM the Clinical Manager stated that the wound was larger, and the RN called the physician to update. The Clinical Manager stated that although it is not specifically stated in the documentation, she believed that there was a visual with the physician. She later stated that she did not see any specific documentation in the record to indicate the RN followed up with the physician. During interview on 09/28/2023 at 10:51 AM the Area Vice President of Operations stated that there is no evidence in the record of a follow-up with the physician. The agency failed to communicate patient findings and needs with the physician as evidenced by the following: Patient #2 - This 79-year-old patient with diagnoses that include venous insufficiency, non-pressure chronic ulcer of the right lower leg, chronic pain, and type 2 diabetes was admitted to the home care agency on 06/22/2018. This record was chosen as a potentially avoidable event for Substantial Decline in Management of Oral Medications. Review of the Home Health Certification and Plan of Care for certification period 09/29/2022 to 11/27/2022 revealed the following orders: - Acetaminophen 650 mg, every 6 hours by mouth, as needed (PRN) for pain; - Gabapentin 100 mg, take 1 capsule by mouth, 3 times per day for neuropathy; - Lidocaine 5% topical cream, 2 times daily PRN for pain; - Tramadol 50 mg, take 2 tablets by mouth, every 8 hours PRN for pain; and - Tramadol 50 mg, take 2 tablets by mouth, every 12 hours PRN for pain. Review of the RN (Registered Nurse) ROC (Resumption of Care)/Recert Within 5 Day Window dated 09/27/2022 revealed the RN documented the patient has 7 out of 10 pain. Review of the SN (Skilled Nurse) Subsequent Visit dated 10/01/2022 revealed the Licensed Practical Nurse (LPN) documented the patient has 7 out of 10 pain. Review of the SN Subsequent Visit dated 10/04/2022 revealed the RN documented the patient has 6 out of 10 pain. Review of the SN Subsequent Visit dated 10/07/2022 revealed the LPN documented the patient has 6 out of 10 pain. Review of the SN Subsequent Visit dated 10/14/2022 revealed the LPN documented the patient has 3 out of 10 pain. Review of the SN Subsequent Visit dated 10/18/2022 revealed the LPN documented the patient has 4 out of 10 pain. Review of the PT (Physical Therapy) Add-On Evaluation dated 10/19/2022 revealed the PT documented the patient has 8 out of 10 pain. Review of the SN Subsequent Visit dated 10/21/2022 revealed the RN documented the patient has 7 out of 10 pain. Review of the PT/PTA (Physical Therapy Assistant) Subsequent Visit dated 10/26/2022 revealed the PT documented the patient has 8 out of 10 pain. Review of the SN Subsequent Visit dated 10/28/2022 revealed the LPN documented the patient has 6 out of 10 pain. Review of the SN Subsequent Visit dated 11/01/2022 revealed the RN documented the patient has 6 out of 10 pain. Review of the PT/PTA Subsequent Visit dated 11/01/2022 revealed the PT documented the patient has 7 out of 10 pain. Review of the SN Subsequent Visit dated 11/08/2022 revealed the RN documented the patient has 7 out of 10 pain. Review of the Physician Order dated 11/08/2022 revealed a discontinuation order for Tramadol 100 mg, every 8 hours by mouth, PRN for pain. Review of the patient care record from 09/27/2022 to 11/08/2022 lacked documented evidence the physician was notified about the patient’s persistent pain or the need to discontinue the Tramadol. During interview on 10/04/2023 at 10:57 AM, the Area Vice President of Operations stated she does not see documentation of communication with the physician or the reason for the discontinuation in the visit note, but the RN who obtained the order may have just been cleaning things up using the referral medication list. Review of agency’s policy entitled “Incident/Occurrence Reporting System” last review date 06/06/2023 revealed the following: Definition: An incident/occurrence is any situation occurring “out of the ordinary” from what is routine and expected during the patient’s length of service and/or the employee’s workday. 1. An Incident/Occurrence Report is completed by the employee/staff member who is involved in the incident/occurrence, or who initially receives information from the patient or family regarding an occurrence (patient incident/occurrence). The incident/occurrence is reported by the employee/staff member to their immediate supervisor. 10. The documentation captured in the incident/occurrence report will contain the incident/occurrence, the interventions taken and the communication/follow-up with physician. Patient #8 – This 89-year-old patient with diagnoses that include other symptoms and signs with cognitive function following cerebral infarction, vascular dementia, and essential (primary) hypertension was admitted to the agency on 06/28/2023. Review of the OT (Occupational Therapy)/OTA (Occupational Therapy Assistant) note dated 08/28/2023 revealed the OTA documented the following: PT (patient) reports having a fall this morning when attempting to sit in the dining room chair. PT reports she missed the chair and landed on the floor. She did not hit her head, report UE (Upper Extremity) soreness from pulling herself up. Review of the Patient Occurrence Report dated 08/28/2023 at 01:20 PM revealed the OTA documented the following: Nature of Occurrence: Unattended Falls, Not Requiring Employee Intervention. Description of Occurrence: PT reports attempting to sit in dining room chair and missed the chair landed on bottom. PT did not hit her head and no injury to report other than UE soreness from pulling her up. COTA left voicemail on nursing line of Doctor’s office. There is a lack of documented evidence of the physician response to the occurrence. During an interview on 09/27/2023 at 01:24 PM, the OTA stated that she did notify the patient’s doctor and completed an occurrence report. The OTA continued to state occurrence reports go to the clinical managers workflow and that the clinical manager addresses on the occurrence report if there is injury or follow up needed. The OTA continued to state there was not on this particular case and no follow up was needed. During an interview on 09/29/2023 at 01:00 PM, the Director of Operations stated that there is no note and there should be another attempt to notify the patient’s doctor of the fall and if no response then a note should be documented to show that multiple attempts were made or what the response was from the doctor’s office.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on personnel record reviews, the New York State Home Care Registry (HCR), and staff interview, the agency failed to ensure for one (1) of four (4) Aides (Employee H) that all Aides have completed an approved NYS Home Health Aide training program. Failure to ensure that all aides have completed an approved Home Health Aide (HHA) training program places patients at risk for poor quality of care and potential harm. The agency failed to ensure all aides have completed an approved NYS HHA Training Program as evidenced by the following: Employee H- This Personal Care Aide (PCA) was hired by the agency on an unknown date. The active employee roster provided to surveyors on 09/11/2023 at 10:00 AM lists the employee’s dates of hire as 11/10/1993 and 03/26/2008. The Home Care Registry shows the employee’s hire date as 02/14/2005, and the Employment Eligibility Verification United States Citizenship, and Immigration Services (USCIS) Form I-9 shows the employee’s first day of work as 11/10/1993. Review of the employee’s personnel file revealed the following: -The employee was hired as a Home Health Aide. -The Job Description signed by the employee on 10/13/2017 is for a Home Health Aide. -The employee file contains a certificate for a Personal Care Aide (PCA), and a “Certificate of Completion” for successful completion of a Home Health Aide Training Program; however, the certificate is not signed by an authorized representative of the HHA Training Program, and is invalid because it cannot been authenticated. The HCR was viewed on 09/26/2023. The profile lists the aide’s certifications a PCA effective 02/14/2005. The is no evidence that the employee is certified as a HHA. During interview on 10/04/2023 at 03:02 PM, the Office Manager (OM) stated, “If they were hired as a PCA, they should have gone through the HHA training. They have a thick record, but the HHA certification should be in there.” At 03:03 PM, the OM stated they found the HHA certification and would send it. HHA Certificate of Completion dated 12/26/1993 was received from the agency on 10/04/2023 review of document revealed the certificate is not signed by an Official Agency Designee and is invalid. As of exit, no further information was provided to refute the findings.

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 review of clinical records, agency policies and procedures, and staff interview for three (3) of seventeen (17) Patients (Patient #s: 1, 7, and 11) the agency failed to ensure staff clinical staff provided care in accordance with agency policies and procedures, current clinical practice guidelines and accepted standards of practice. Failure to provide services in accordance with agency policies and procedures, and accepted practices has the potential to cause patient harm. Review of the agency’s Guide for Measuring Wounds, revised 07/2019, revealed “To conform to specific instructions provided by the WAT (Wound Assessment Tool) in HCHB, the [agency name] policy on measuring (WC-001) was updated July 1st, 2016. As per the WAT instructions, the updated policy will change the method for how wounds will be measured to the following: Length is measured by placing the measuring device at the longest length of the wound. Width is measured by placing the measuring device side to side at the greatest width perpendicular to the length. Depth is measured by inserting a cotton-tipped applicator at the deepest point in the wound. Hold the cotton tipped applicator with thumb and index finger to mark the depth and hold against a measuring device to determine the depth. For open wounds with shallow un-measurable depth, indicate by 0.1 cm. Tunnels and undermining are documented according to the face of a clock with 12 o’clock being toward the head and 6 o’clock being toward the toes. Example: 6cm tunnel at 4 o’clock. 3cm undermining from 1 o’clock to 7 o’clock. All wound measurements will be measured in centimeters (cm) and per Medicare Guidance measurements, should be rounded to the nearest tenth of a centimeter. Measure wounds at a minimum frequency of once each calendar week (usually the first visit of the week). Note: when the ordered frequency is less than weekly, the wound is measured on each visit. There are multiple ways to measure a wound. There is no clear method of measuring that is more appropriate than others. Consistency in measuring across the board yields the best results… With chronic untreated venous stasis disease and some other disease processes, you will sometimes have multiple open, weepy areas encompassing the entire circumference of the leg. It would be literally impossible to document the location and the precise measurement of every lesion. Do your best to write a thorough description of what you are seeing. Remember, a picture paints a thousand words, photos are essential on these types of wounds.” Review of the agency’s policy entitled “The Provision of Wound and Skin Care” last reviewed 03/08/2023 revealed “ In accordance with best practice and standard of care, wounds will be measured a minimum of one time a week, preferably on the first visit of the week, by the same nurse, utilizing the same tool and measurement terminology.” Patient #1- This 98 year old patient with diagnoses that include Superficial frostbite of right toe(s), superficial frostbite of left toe(s) and hypothyroidism was admitted to the agency on 11/12/2022 and was discharged on 05/08/2023. The agency failed to ensure Skilled Nurses measured wounds in accordance with agency policies and procedures as evidenced by the following: Review of the Wound Assessment Tool Reports from 01/05/2023 to 05/08/2023 revealed the following: A.) Wound #1 located on the patient’s left great toe (frostbite) measurements: -On 01/05/2023 the RN documented the wound was measured as 8.5 cm length (l) x 4.5 cm width (w) x 0.1 cm depth (d). -On 01/09/2023 the RN documented the wound measured 8.5 cm x 4.5 cm x 0.1 cm. -On 01/18/2023 the RN documented the patient’s wound measured 8 cm x 4.5 cm x 0.1 cm. -On 01/23/2023 the RN documented the patient’s wound measured 8 cm x 4.5 cm x 0 cm. -On 01/30/2023 the RN documented the patient’s wound measured 8 cm x 4.5 cm x 0.1 cm. -On 02/06/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 02/13/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 02/20/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0 cm. -On 02/27/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0 cm. -On 03/06/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 03/09/2023 the RN documented the patient’s wound measured 8 cm x 4.2 cm x 0.1 cm. -On 03/13/2023 the RN documented the patient’s wound measured 8 cm x 4 cm x 0.1 cm. -On 03/20/2023 the RN documented the patient’s wound measured 8 cm x 4 cm x 0.1 cm. Review of the RN Add-On Evaluation dated 01/05/2023 revealed the RN obtained photographs of the patient’s left great toe and foot. Review of the photograph revealed a wound measurement tape was placed on the anterior medial aspect of the patient’s foot. The anterior medial aspect of the patient’s foot measured side to side (width) was approximately 7.5 cm. Based on the photograph, the patient’s great toe is proportionate in size to the foot. B.) Wound #2 located on the right great toe (frostbite) measurements: -On 01/05/2023 the RN documented the wound was measured as 10 cm length (l) x 1 cm width (w) x 0.2 cm depth (d). -On 01/09/2023 the RN documented the wound measured 10 cm x 1 cm x 0.2 cm. -On 01/18/2023 the RN documented the patient’s wound measured 10 cm x 1 cm x 0.1 cm. -On 01/23/2023 the RN documented the patient’s wound measured 6 cm x 1 cm x 0.1 cm. -On 01/30/2023 the RN documented the patient’s wound measured 5.5 cm x 1 cm x 0.1 cm. -On 02/06/2023 the RN documented the patient’s wound measured 5 cm x 2 cm x 0.1 cm. -On 02/13/2023 the RN documented the patient’s wound measured 2.5 cm x 2.5 cm x 0.1 cm. -On 02/20/2023 the RN documented the patient’s wound measured 2.9 cm x 2.5 cm x 0.1 cm. -On 02/27/2023 the RN documented the patient’s wound measured 3 cm x 2.2 cm x 0.1 cm. -On 03/06/2023 the RN documented the patient’s wound measured 3 cm x 2 cm x 0.1 cm. -On 03/09/2023 the RN documented the patient’s wound measured 3 cm x 2 cm x 0.1 cm. -On 03/13/2023 the RN documented the patient’s wound measured 3 cm x 2 cm x 0.1 cm. -On 03/20/2023 the RN documented the patient’s wound measured 2 cm x 2 cm x 0.1 cm. -On 04/26/2023 the Skilled Nurse (SN) documented the patient’s wound measured 5 cm x 0.4 cm x 0.1 cm. Review of the RN Add-On Evaluation dated 01/05/2023 revealed the RN obtained a photograph of the patient’s right great toe and foot. Review of the photograph revealed a wound measurement tape was placed on the anterior medial aspect of the patient’s foot. The anterior medial aspect of the patient’s foot measured side to side (width) was approximately 7 to 7.5 cm. Review of the photograph revealed the patient’s great toe is proportionate in size to the foot. During interview on 09/28/2023 beginning at 09:41 AM the RN initially stated that she measured length x width x depth, and that the patient’s entire toes were necrotic. The RN then stated that the RN believed the measurement was front to back and “I think I was saying front on necrotic.” The RN stated that she measured the front, around to the back of the toe and not just top to bottom. During interview on 09/28/2023 beginning at 09:43 the Clinical Manager stated that the agency’s policy for wound measurement states to measure the longest point of the wound in any direction. During interview on 09/28/2023 at 09:51 AM the Area Vice President of Operations (AVPO) stated the agency’s wound guidance states that length is measured at the largest length of the wound and width is perpendicular. The AVPO added that there are multiple ways to measure a wound, but consistency yields the best results, and the wound measurements were consistent. C.) Review of the Visit Note Reports from 03/19/2023 to 05/08/2023 (the date the patient was discharged from the agency) revealed the patient has three wounds requiring weekly measurements as follows: Wound #1, left great toe (frostbite), wound #2, right great toe (frostbite), and wound #3 anterior 2nd left toe. -On 03/20/2023 all three wounds were measured as follows: Wound #1 measured 8 cm x 4 cm x 0.1 cm. Wound #2 measured 2 cm x 2 cm x 0.1 cm Wound #3 measured 2 cm x 2 cm x 0.1 cm -During the week from 03/26/2023 to 04/01/2023, no wound measurements were obtained. - During the week from 04/02/2023 to 04/08/2023, no wound measurements were obtained. -During the week from 04/16/2023 to 04/22/2023, no wound measurements were obtained. -During the week from 04/23/2023 to 04/26/2023, wound # 1 (left great toe was measured), wounds #2 and #3 were not measured. -During the week from 04/30/2023 to 05/06/2023, no wounds were measured. During interview on 09/27/2023 at 10:26 AM the RN stated that she did not measure the wounds because they were multiple scattered wounds and the entire left and right toe were entirely necrotic. During interview on 09/27/2023 the Clinical Manager stated that measurements should have been obtained on the 04/03/2023 visit by the Licensed Practical Nurse (LPN) that is no longer employed by the agency. She stated that the RN should have obtained the measurements as it is the RN’s responsibility. The Clinical Manager stated that it is the agency’s policy to obtain measurements weekly. Review of the agency’s policy entitled “Criteria for Admission” last review date 06/26/2023 revealed the following: Non-Admission: When patients are not admitted to the agency after an assessment visit because they do not meet one (1) or more of the criteria listed above, agency staff will take the following action: 1. When patients are not admitted to the agency after an assessment visit because they do not meet one or more criteria listed, - all information, i.e., the patient assessment, referral form, and a coordination care note explaining the reason for non-admission will be maintained and accessible in the electronic medical record system. Patient #7 – This 94-year-old patient with diagnoses that include polycythemia vera, pain in right hip, and constipation was admitted to the agency on 05/05/2023. Review of the Referral from the Medical Group dated 04/13/2023 faxed on 04/28/2023 revealed the following: Reason for Referral: evaluate and treat wound care. Nurse Note: Acute visit. Pressure sore on right hip for a couple weeks. Subjective: Patient presents to discuss sore right hip. C/O (Complains of) sore right hip/buttocks region x (times) four (4) weeks. Objective: Skin – one (1) cm (centimeter) superficial open area right lateral buttocks hip region. Assessment #1: Open wound of right hip region. Review of the Coordination Note dated 05/01/2023 revealed the Licensed Practical Nurse (LPN) documented the following: Primary Diagnosis/Reason for Home Health: Wound care pressure sore right hip, T9 complete fracture, and osteoporosis. Disciplines ordered: SN (Skilled Nurse). Review of the Coordination Note dated 05/02/2023 Patient Service Coordinator – Non-clinical documented the following: Date of planned admission: Yes, 05/04/2023. The name of the admitting clinician (if known) and that the clinician will be calling them to schedule the visit: Yes, RN (Registered Nurse) Case Manager. Review of the clinical record from 04/28/2023 to 09/14/2023 lacked documented evidence that a SN went out to complete an initial assessment visit and documented a coordination care note explaining the reason for non-admission. The agency failed to ensure the RN followed the agency’s policy and document a coordination care note explaining the reason for non-admission. During an interview on 09/25/2023 at 12:08 PM, the Clinical Manager (CM) stated that a Registered Nurse (RN) did go out to the patient’s home on 05/04/2023 and completed an assessment of the patient. The CM continued to state that upon the RN’s assessment of the patient there was no skilled need, and that the RN did not document this assessment in the clinical record and should have documented the assessment. The CM continued to that the RN notified her of the visit and the that she should have documented the conversation, and that the patient did not have a skilled need at this time. Review of the agency’s entitled “The Provision of Wound and Skin Care” last review date 03/28/2023 revealed the following: Measuring: In accordance with best practice and standard of care, wounds will be measured a minimum of one time a week, preferably on the first visit of the week, by the same nurse utilizing the same tool and terminology. The preferred day for measuring the is the first visit of the week. Patient #7 – This 94-year-old patient with diagnoses that include polycythemia vera, pain in right hip, and constipation was admitted to the agency on 05/05/2023. Review of the Physician Order dated 06/21/2023 revealed an order for SN (Skilled Nurse) to evaluate and treat lower extremity wound. Review of the Add on Discipline order date 06/22/2023 revealed the following orders: Skilled nurse to perform/teach patient/caregiver on wound care to skin tear to right calf, cleanse with normal saline, apply collagen calcium AG (unknown abbreviation) to wound bed, and cover with foam dressing. May secure with transparent dressing. Perform wound care 2X/WK (two times a week) and PRN (as needed) soiled and/pr dislodged dressing. Patient/caregiver may perform care. May cleanse with normal saline and cover with nonstick pad secured with tape until supplies arrives. Review of the RN (Registered Nurse) Add-On Evaluation dated 06/22/2023 revealed the following: Unspecified open wound, right lower leg, initial encounter. #1 – RT (Right) – Dist (Unknown Abbreviation) Calf, RT, Skin Tear Wound Assessed: Yes. Measurements Taken: Yes. Length x Width x Depth (CM) (centimeters) 5 x 2.5 x 1. Review of the SN (Skilled Nurse) Subsequent Visit note dated 06/29/2023 revealed the RN documented the following: #1 – RT (Right) – Dist (Unknown Abbreviation) Calf, RT, Skin Tear Wound Assessed: Yes. Measurements Taken: No. Reason Measurements not Taken: Not Due. There is a lack of documented evidence of weekly wound measurements for the week of 06/25/2023 to 07/01/2023. The agency failed to follow their policy and procedure for wound measurements. During an interview on 09/25/2023 at 02:33 PM, the Clinical Manager stated there should be weekly wound measurements and that she does not see any wound measurements in the clinical record for this week. Review of the agency’s policy entitled “Abbreviations, Acronyms, & Symbol List” last review date 03/07/2023 revealed the following: - Whenever possible, agency staff/contractors will use the agency Standardized Abbreviation listing when making entries into the clinical record. - To provide a list of abbreviations, acronym, and symbols that are acceptable for use in the clinical record. Considerations: The following is a list of abbreviations adopted by the agency: - Great care should be taken to use legible penmanship when documenting abbreviations, acronyms, and symbols. - This list should be maintained on an ongoing basis in order that it be kept up to date. Patient #11 – This 75-year-old patient with diagnoses that include Alzheimer’s disease, dementia in other diseases classified elsewhere, unspecified severity, with agitation, and iron deficiency anemia was admitted to the agency on 08/12/2023. Review of the PT/PTA Subsequent Visit note dated 09/08/2023 revealed the PTA documented the following: patient is present when I arrived. Vital signs assessed. EDN (unknown abbreviation) issued. During an interview on 09/28/2023 at 02:31 PM, the PTA stated that EDN stood for Advanced Directive Notice or Expedited Discharge Notice and that she has been using that abbreviation for the past fourteen (14) years. Review of the agency’s policy entitled “Abbreviations, Acronyms, & Symbols” last review date 03/07/2023 lacked documented evidence of the abbreviation of EDN. During an interview on 09/28/2023 at 02:32 PM, the Area Vice President of Clinical stated that EDN was not an approved abbreviation and that she will take the unapproved abbreviation to the agency for review.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for one (1) of seventeen (17) patients (Patient #16) the agency failed to ensure that the patient's current comprehensive assessment, including all the assessments from the most recent home health admission, clinical notes, plans of care, and physician orders reflects the most current and accurate patient assessment. Failure to establish and clearly document the patient's current comprehensive assessment, including all the assessments from the most recent home health admission, and clinical notes has the potential for staff to make clinical decisions based on inaccurate and/or missing information with the potential to result in negative patient outcomes. Patient #16 – This 89-year-old patient with diagnoses that include metabolic encephalopathy, atrial fibrillation, and hypertensive heart disease with heart failure was admitted to the home care agency on 08/23/2023. Review of the Client Coordination Type – Note Type Discharge Summary revealed the RN documented the patient was discharged on 08/28/2023 because the patient was opened to another Certified Home Health Agency (CHHA) on 08/25/2023, the Occupational Therapist (OT) discussed with the patient the ability to work with only one agency, the OT gave the patient her options, and the patient opted to work with the other CHHA. Review of the clinical record lacked documented evidence of an assessment, or a clinical note completed by the OT from the visit conducted on 08/28/2023. During interview on 09/26/2023 the OT stated that when she went in to the patient’s room on 08/28/2023 the patient was working with a therapist from the other CHHA. The OT stated that she did not even start her evaluation and she contacted the manager immediately. The OT stated that her manager instructed her to ask the patient which agency she wanted to work with, and the patient selected the other CHHA. Lastly, the OT stated that it was her fault and that she should have done a coordination note when she found this out.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with staff, for two (2) of seventeen (17) patients (Patient #s: 2 and 4), the agency failed to ensure all documentation by professional staff is appropriately authenticated in accordance with accepted standards of practice. Specifically, the physician orders and plans of care lack legible identifiers and documentation of the physician's credentials. Failure to authenticate documentation with professional credentials has the potential for patients to receive care from unlicensed staff. Patient #2 - This 79-year-old patient with diagnoses that include venous insufficiency, non-pressure chronic ulcer of the right lower leg, chronic pain, and type 2 diabetes was admitted to the home care agency on 06/22/2018. This record was chosen as a potentially avoidable event for Substantial Decline in Management of Oral Medications. A. Review of the Home Health Certification and Plan of Care for certification period 09/29/2022 to 11/27/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. B. Review of the Add On Discipline Physical Therapy Plan of Care dated 10/19/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. C. Review of the Physician Order dated 11/08/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. D. Review of the Physician Order dated 11/22/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. E. Review of the Physician Order dated 11/29/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. During interview on 09/26/2023 at 04:00 PM, the Clinical Manager stated she would look for a signature log. As of exit, no further evidence was provided to refute the findings. Patient # 4 – This This 74-year-old patient with diagnoses that include right femur stress fracture, right artificial hip, and delusional disorders was admitted to the home care agency on 10/21/2022. This record was chosen as a potentially avoidable event for Discharge to the Community Needing Toileting Assistance and Discharge to the Community with Behavioral Health Problems. A. Review of the Home Health Certification and Plan of Care for certification period 10/21/2022 to 12/19/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. B. Review of the Add On Discipline Occupational Therapy Plan of Care dated 10/24/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. C. Review of the Face to Face Clarification Addendum dated 11/02/2022 revealed an illegible signature and there was no legible identifier. The agency failed to ensure documentation is legible and authenticated. During interview on 09/26/2023 at 04:00 PM, the Clinical Manager stated she would look for a signature log. As of exit, no further evidence was provided to refute the findings.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on review of clinical records and interview with agency staff for one (1) of five (5) patients (Patient #2), the agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. Specifically, the Physical Therapist (PT) failed to assess the manner the patient receives her medications. Failure to ensure comprehensive assessments accurately reflect the patient status and needs has the potential for unmet patient needs and the potential for negative patient outcomes. Findings are: Patient #2 - This therapy-only 54-year-old patient with diagnoses that include a right tibia fracture, anxiety and hyponatremia was admitted to the home care agency on 09/09/2021. Review of the PT OASIS (Outcome and Assessment Information Set) Admission Note dated 09/09/2021 revealed the PT documented the following: - Patient lives alone; - Family not present for PT visit; - Patient cannot see medication labels or newsprint; - Patient is unable to take medication unless administered by another person; - Patient reports two family members will provide intermittent assistance to her and - Patient reports compliance with medications as prescribed. - The PT failed to assess the manner the patient receives medications. During interview on 09/21/2021 at 11:40 AM, the PT stated the patient's family prefill the patient's medications in a pill box routinely, but he failed to document this.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for two (2) of five (5) patients (Patient #'s: 1 and 5), the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Findings are: Patient #1 - This therapy-only 79-year-old patient with diagnoses that include psychophysiologic insomnia, acute kidney failure, and adjustment disorder was admitted to the home care agency on 09/15/2021. Review of the Home Health Certification and Plan of Care for certification period 09/15/2021 to 11/13/2021 revealed the following orders: - Fingerstick frequency of patient/caregiver three times a day - Lantus Solostar U-100 insulin 100 unit/ml (units per milliliters) 10 units two times a day subcutaneous - Novolog Flexpen U-100 Insulin Aspart 100 unit/ml 48 units daily subcutaneous Review of the PT (Physical Therapy) OASIS (Outcome and Assessment Information Set) Admission Note dated 09/15/2021 revealed the PT documented "Patient unable to test at this time due to wrong test strips. Is getting correct ones." There is a lack of documented evidence the PT observed a demonstration of the patient/caregiver obtaining a blood glucose or administrating insulin. Review of the clinical record lacks documented evidence the patient received appropriate education regarding obtaining a blood glucose and administering insulin. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose or administer a subcutaneous diabetic medication. During interview on 09/21/2021 at 12:50 PM, the Area Vice President (VP) of Operations (the PT was unavailable) stated there is no documented evidence the PT observed the patient/caregiver demonstrate obtaining a blood glucose or administering insulin. Patient # 5 - This therapy-only 70-year-old patient with diagnoses that include pneumonia, presence of left artificial hip joint, and parkinson's disease was admitted to the home care agency on 08/08/2021. Review of the Home Health Certification and Plan of Care for certification period 08/08/2021 to 10/06/2021 revealed the following orders: - Fingerstick frequency of patient/caregiver three times a day - Insulin Lispro (U-100) 100 unit/ml subcutaneous pend before meals inject as per sliding scale: if 70-130 = 0 units, 131-180= 4 units, 181-240 = 8 units, 241-300 = 10 units, 301-350=12 units, 351-400=16 units, 401-999= 20 units, > 400 call MD (medical doctor). Review of the PT OASIS Admission Note dated 08/08/2021 revealed the PT documented the following assessment: - How is insulin administered: insulin pen - Can the patient self-inject injectable medication (insulin)?: yes - What is the client's usual blood sugar readings?: 130-280 Review of the PT OASIS Admission Note dated 08/08/2021 lacks documented evidence the PT observed a demonstration of the patient/caregiver obtaining a blood glucose or administrating insulin. Review of the clinical record lacks documented evidence the patient received appropriate education regarding obtaining a blood glucose and administering insulin. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose or administer a subcutaneous diabetic medication. During interview on 09/21/2021 at 12:35 PM, the Director of Operations (DOO), Niagara Falls (the PT was unavailable) stated the patient lives in an adult living facility and is expected to administer his own insulin, however the PT did not document observing him obtain a blood glucose or administering insulin.