Alleviation Healthcare Services, Inc.

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The Home Health Agency (HHA) failed to ensure an individualized written Plan of Care (POC) was implemented for six of 17 sampled patients (Patient 5, Patient 7, Patient 8, Patient 9, Patient 11 and Patient 13). This failure had the potential to result in health status decline that could affect their quality of care and well-being. Refer to G572. 2. The HHA staff failed to ensure the patient’s plan of care (POC) included pertinent clinical information and addressed these identified needs in the current plan of care for two of 17 sampled patients (Patient 3 and Patient 7). This failure had the potential to result in patients not receiving the identified needs and services, and will have a decline in health status, that could affect their quality of care and well-being. Refer to G574. 3. The Home Health Agency (HHA) staff failed to notify the physician of the patient’s change of condition for one of 17 sample patients (Patient 9). This failure resulted in the patient’s physician not informed of patient’s progress or decline of his/her clinical status prolonging the patient’s certification to receive the home health benefits. Refer to G590 4. The Home Health Agency (HHA) failed to ensure two of 17 sampled patients (Patient 7 and Patient 9) received education and training regarding care and services identified in the plan of care. This failure resulted in putting patients at risks for injury and hospitalizations. Refer to G610. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure an individualized written Plan of Care (POC) was implemented for six of 17 sampled patients (Patient 5, Patient 7, Patient 8, Patient 9, Patient 11 and Patient 13). This failure had the potential to result in health status decline that could affect their quality of care and well-being. 6. A review of Patient 13’s face sheet indicated he was admitted to the HHA agency on 10/21/2024 with an admitting diagnosis of type 2 diabetes (type of diabetes mellitus with high blood sugar and insulin resistance). A review of Patient 13’s plan of care indicated skilled nurse visits once per week. It further indicated the skilled nurse was to assess O2 saturation on room air for every visit. On 1/29/2025 at 12:30 pm., during a review of the nurse’s notes, it indicated documented evidence the O2 saturation level was completed or documented for 1/3/2025 and 1/17/2025. On 1/13/2025 at 3:40 pm., an interview was conducted with the Director of Nursing (DON) in her office. DON confirmed the MD orders for Patient 13’s O2 saturation level was to be taken and documented each visit. DON stated no O2 saturation was done or documented on 1/3/2025 and 1/17/2025. During a review of the agency’s policy entitled “Rights/Responsibilities” with a revised date of November 2020, indicated the organization shall ensure that the patient receives all services outlined in the plan of care. 1. During a record review of Patient 5’s medical record form titled “Patient Information” indicated a start of care date of 10/10/2024 with a primary diagnosis of Alzheimer’s Disease (progressive memory loss) with late onset. During a record review of Patient 5’s medical record form titled “OASIS-E Start of Care” dated 10/10/2024, indicated Patient 5’s oxygen saturation (the percentage of oxygen carried by the red blood cells in the bloodstream) on room air was at 95%. The form also indicated the Skilled Nurse (SN) was to assess Patient 5’s oxygen saturation on room air at every SN visit During a record review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care” dated from 10/10/2024 to 12/8/2024, indicated the SN was to assess Patient 5’s oxygen saturation on room air at every SN visit and notify the medical doctor is oxygen saturation was less than 92%. During a record review of Patient 5’s medical record forms titled “LVN (license Vocational Nurse) F/U (follow up)” dated 10/22/2024 and 10/31/2024, indicated Patient 5’s oxygen saturation was not assessed. During a record review of Patient 5’s medical record forms titled “Wound Measurement 2/ pic (with picture)” dated 11/8/2024, indicated Patient 5’s oxygen saturation was not assessed. During a record review of Patient 5’s medical record forms titled “Skilled Nursing Visit” dated 11/11/2024, indicated Patient 5’s oxygen saturation was not assessed. During a concurrent interview and record review on 1/31/2025 at 3:05 p.m. with the Director of Patient Care Services (DPCS) of Patient 5’s electronic medical record (EMR), the DPCS stated Patient 5’s individualized plan of care indicated her oxygen saturation was to be assessed with every skilled nurse visit. The DPCS stated Patient 5’s skilled nurse visit notes dated 10/22/2024, 10/31/2024, 11/8/2024, and 11/11/2024, did not indicate Patient 5’s oxygen saturation was assessed. The DPCS stated the skilled nurse was required to assess Patient 5’s oxygen saturation because there were reportable parameters. The DPCS stated it was important to assess Patient 5’s oxygen saturation to note any changes that need to be reported to her physician. 2. A record review of Patient 7’s Patient Information sheet indicated a start of care date on 12/21/2024 with a primary diagnosis of Type 2 diabetes (too much sugar in the blood) with foot ulcer (opening of the skin). During an observation of the home visit on 1/29/2025, at 10:45 a.m., Licensed Vocational Nurse 3 (LVN 3), provided wound care to Patient 7’s left toe. During the visit, LVN 3 did not teach Patient 7 how to do the wound care. During a concurrent interview and record review on 1/30/2025, at 1:45 p.m., the Director of Patient Care Services (DPCS), reviewed Patient 7’s plan of care titled, “Home Health Certification and Plan of Care”, dated 12/21/2024 to 2/18/2025. The record indicated, “SN (skilled nurse) to instruct Patient/Caregiver on wound care as follows: Left Second Toe: Cleanse wound with Normal Saline solution, pat dry, paint with betadine, (a type of cleaning solution) wrap with kerlix (a type of dressing) and secure with tape. To be performed daily.” The DPCS stated the nurse was supposed to instruct the patient and/or caregiver about daily wound care every visit. During a concurrent interview and record review on 1/30/2025, at 1:45 p.m., the DPCS, reviewed Patient 7’s visit notes dated 1/1/25, 1/3/25, 1/6/25, 1/8/25, 1/10/25, 1/13/25, 1/14/25, 1/17/25, 1/23/25, 1/24/25, and 1/28/25. The DPCS stated she could not find anything that said Patient 7 was instructed to do wound care. There was nothing that specified that the nurse taught the patient or care giver. The DPCS stated the notes needed to specify that the nurse instructed on the wound care and frequency of wound care. This was important to know what the situation was. Maybe the nurse did teach the patient how to do it, and patient is refusing or needing more teaching. We could notify the doctor about it. When asked what can happen if the patient is not doing daily wound treatment as ordered, the DPCS stated the wound can deteriorate, get infected, which could cause Patient 7 to go back to the hospital. 3. A record review of Patient 8’s Patient Information sheet indicated a start of care date on 4/15/2023 with a primary diagnosis of encounter for attention to colostomy (an opening (stoma) in the belly which waste from the intestine can come out). During an observation of the home visit on 1/29/2025, at 11:30 a.m., Registered Nurse 2 (RN 2) provided care to Patient 8. During an observation of the nurse assessment on 1/29/2025, at 11:37 a.m., RN 2 did not check Patient 8’s oxygen saturation (the amount/percentage of oxygen in the blood). During a concurrent interview and record review on 1/29/2025, at 11:58 a.m., RN 2 reviewed Patient 8’s record titled, “Home Health Certification and Plan of Care, dated 12/5/2024 to 2/2/2025”. The record indicated the skilled nurse to check oxygen saturation (O2) every visit. RN 2 initially stated she did not check Patient 8’s O2 saturation because the patient was not having any respiratory issues. RN 2 stated she did not see the order on the document. RN 2 stated it was important to check the O2 saturations to make sure the oxygen levels were fine. 4. A record review of Patient 9’s Patient Information sheet indicated a start of care date on 12/26/2024 with a primary diagnosis of encounter for aftercare following liver transplant. During an interview on 1/31/2025, at 12:42 p.m., Patient 9’s family member (FM 2) stated the nurse visited Patient 9 once a week and the nurse never did wound care. FM 2 stated the nurse just looked at the wound. FM 2 stated Patient 9 went to the doctor’s office last week and the doctor removed the scab on the belly. During a concurrent interview and record review on 1/31/2025, at 1:02 p.m., the DPCS reviewed Patient 9’s record titled, “Home Health Certification and Plan of Care”, dated 12/26/24 to 2/23/24. The record indicted, “SN to instruct patient/caregiver on wound care as follows: Perform instruct wound care to abdominal incision wash with soap and water daily pat dry leave open to air daily. Caregiver to perform wound care on non-skilled nurse visit days.” The DPCS further reviewed Patient 9’s visit note dated 1/3/2025 and stated the document did not indicate that the wound care was done nor the patient was instructed to do wound care. The DPCS stated the document indicated the wound was closed. If the wound was closed, the nurse was supposed to notify the doctor and case management so an order can be obtained to discontinue the wound care. The DPCS stated there was no doctor’s orders to discontinue the wound care. The importance of notifying the doctor was so the doctor know how the wound is doing, that is has closed. When the wound is closed, the doctor sometimes wants the HHA to monitor the wound even though it is closed. The nurse should have notified the HHA that the wound was closed. During a concurrent interview and record review on 1/31/2025, at 1:08 p.m., the DPCS reviewed Patient 9’s visit notes of 1/11/2025. The DPCS stated the note did not mention that the wound was closed. Based on the documentation, the HHA did not know if the wound remained closed. For active wounds, pictures were supposed to be taken once a week. Since there was no order to discontinue wound care, the wound was considered active. The DPCS stated there was no pictures of the wound uploaded in Patient 9’s medical records. The purpose of taking pictures of the wounds weekly was to monitor, to see if the wound was healing or worsening, to send to the doctor if requested. The pictures help the HHA know how the wound is healing. The DPCS continued to review the notes and stated there was no documentation that the nurse instructed the patient/caregiver to perform daily wound care when the nurse did not visit. During a concurrent interview and record review on 1/31/2025, at 1:13 p.m., the DPCS reviewed Patient 9’s visit notes of 1/24/2025. The DPCS stated the note did not mention that the wound was closed. Based on the documentation, the HHA did not know if the wound remained closed. The DPCS stated no pictures of Patient 9’s wound were taken. There was no documentation that the nurse instructed the patient/caregiver to perform daily wound care when nurse didn’t come. If the wound was closed, there was no need to measure it. Since the nurse did not mention that the wound remained closed, wound measurements and pictures were still expected. 5. A record review of Patient 11’s Patient Information sheet indicated a start of care date on 2/7/2024 with a primary diagnosis of Type 2 diabetes (too much sugar in the blood) with circulatory complications. During a concurrent interview and record review on 1/31/2025, at 2:36 p.m., the DPCS reviewed Patient 11’s record titled, “Home Health Certification and Plan of Care”, dated 6/6/2024 to 8/4/2024. The record indicated the nurse was to notify the doctor if the fasting (empty stomach) was greater than 250 or less than 60. The DPCS stated the purpose of the SN (skilled nurse) visits was to monitor the blood sugars, teach about medications, and monitor for complications of diabetes such as hypoglycemia (low blood sugar levels) and/or hyperglycemia. During a concurrent interview and record review on 1/31/2025, at 2:36 p.m., the DPCS reviewed Patient 11’s nurse visit records, dated 6/6/2024, 7/1/2024, 7/9/2024, 7/17/24, and 7/25/24. All notes indicated that Patient 11’s daughter stated she did not have a glucometer (a device that measures blood sugar levels). The DPCS stated there was no monitoring of blood sugar levels because the patient did not have a glucometer. The DPCS was asked if there were additional interventions needed. The DPCS stated the HHA tells the nurses that if the patient does not have a glucometer, the nurse needed to call the doctor so a prescription can be obtained to get a glucometer. During a concurrent interview and record review on 1/31/2025, at 2:36 p.m., the DPCS reviewed Patient 11’s record titled, “Patient Communication”, dated 4/16/2024. The DPCS stated this note was from the previous care episode (4/7/2024 to 6/5/2024). The note was about insurance denying authorization for the glucometer. The DPCS stated the doctor should have been called to inform that blood sugar levels could not be monitored. The DPCS stated the doctor was not notified. It was important to notify the doctor because the doctor needed to know that the patient was not checking his blood sugars. If the issue was insurance, the doctor could have been notified, so the HHA can see how it can help getting a glucometer. During a concurrent interview and record review on 1/31/2025, at 2:36 p.m., the DPCS reviewed Patient 11’s record titled, “OASIS-E-Recertification”, dated 4/5/2024. The DPCS stated this was the recertification assessment for certification period 4/7/2024 to 6/5/2024. The record indicated, “Patient/cg (caregiver) has not been able to acquire glucometer, the pop ordered a machine not covered by insurance and per (relative) she has not been able to get a hold of dr. (doctor) Insurance gave dr a list of machines that would be covered”. The DPCS stated there was no additional documentation in the medical records of following up with the glucometer. A record review of Patient 11’s record titled, “Home Health Certification and Plan of Care”, for certification period 4/7/2024 to 6/5/2024, indicated the SN was to instruct patient/caregiver on all aspects of diabetic management to include glucometer use. The record also provided blood sugar parameters, with instructions on when to call the doctor if Patient 11’s blood sugar levels exceeded the parameters. During an interview and record review on 1/31/2025, at 2:36 p.m., the DPCS stated the HHA took care of Patient 11 for 3 episodes of care. The interventions done for Patient 11 not having a glucometer where on 4/5/2024 and 4/26/2024. There was no other follow up or interventions documented. The DPCS stated the importance of Patient 11 checking his blood sugar levels was for the nurse to monitor the blood sugar levels. The nurses do not know if the medications need to be adjusted. The HHA wants to avoid complications of diabetes such as hypo and hyperglycemia. The DPCS stated it was hard to keep track of the patient’s goals when nurses are not monitoring blood sugar levels. A record review of Patient 11’s record titled, “OASIS-E-Start of Care”, dated 2/7/2024, indicated the doctor was contacted about glucometer not being provided to the patient. The record also indicted the nurse was unable to check sugars due to patient not having a glucometer. A record review of Patient 11’s record titled, “Home Health Certification and Plan of Care”, dated 2/7/2024 to 4/6/2024, indicated the SN was to perform finger stick (prick the finger to obtain a blood sample, to check for blood sugar levels) during the visits. A record review of Patient 11’s record titled, “OASIS-E-Recertification”, dated 6/5/2024 indicated Patient 11’s blood sugar levels were checked. The record also indicated Patient 11 was independent with glucometer use. A record review of Patient 11’s record titled, “Discharge Summary”, dated 8/5/2024, indicated Patient 11 was discharged due to episode ended and patient/caregiver are not answering. The record also indicated the goals were not met due to the visits not being completed.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to review and document all the current medications the patients are taking for four of 17 sampled patients (Patient 1, Patient 2, Patient 6, and Patient 7). This failure placed the patients at risk of drug-to-drug interaction and possible side effects that could impact the patient’s health and safety. During an interview on 1/30/2025 at 10:18 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated skilled nurses (SN) are expected to complete a medication reconciliation (a process of comparing a patient’s medication orders to all of the medications that the patient has been taking) during every home visit. The DPCS stated the SN was supposed to notify the patients physician and update their medication profile if there were any changes. The DPCS stated it was important to keep an updated patient medication profile because patients need to be educated on the medications being taken. 1.During a record review of Patient 1’s medical record form titled “Patient Information” indicated a start of care date of 12/14/2024 with a primary diagnosis of type 2 diabetes (high blood sugar) without complications. During a record review of Patient 1’s medical record form titled “Home Health Certification and Plan of Care” dated from 12/14/2024 to 2/11/2025, indicated Patient 1’s current medications were Enalapril (medication for high blood pressure) 20 milligrams (mg) once a day, Potassium Chloride (supplement), and Furosemide (medication to remove excess water from body). During a record review of Patient 1’s medical record from titled “Medication Profile” dated from 12/14/2024 to 2/11/2025, indicated Patient 1’s current medications were Enalapril 20 mg, Potassium Chloride, and Furosemide. During a record review of Patient 1’s medical record form titled “Task Details” dated 1/28/2025, indicated LVN 4 signed and completed Patient 1’s medical record form titled “LVN F/U” on 1/28/2025. During a joint home visit on 1/29/2025 at 10:45 a.m. with License Vocational Nurse 2 (LVN2) to Patient 1’s home, Patient 1’s daughter stated Patient 1’s Potassium and furosemide were discontinued by her primary physician on 12/20/2024. Patient 1’s daughter also stated Patient 1’s Enalapril was decreased to 10mg during same visit. During a concurrent interview and record review on 1/30/2025 at 2:10 p.m., with the Director of Patient Care Services (DPCS) of Patient 1’s electronic medical record (EMR), the DPCS stated Patient 1’s medication list should have been updated when the SN was made aware of any changes to the medications. The DPCS stated LVN 4 was supposed to update Patient 1’s medication list to reflect the change of the Enalapril dosage. 2.During a record review of Patient 2’s medical record form titled “Patient Information” indicated a start of care date of 12/24/2024, indicated a primary diagnosis of trauma subdural hematoma without loss of consciousness. During a record review of Patient 2’s medical record form titled “Home Health Certification and Plan of Care” dated from 12/24/2024 to 2/21/2025, indicated Patient 2’s current medication included Enoxaparin (blood thinner medication) and Sodium Chloride (electrolyte replenisher). During a record review of Patient 2’s medical record form titled “Medication Profile” dated from 12/24/2024 to 2/21/2025, indicated Patient 2’s current medication included Enoxaparin (blood thinner medication) and Sodium Chloride (electrolyte replenisher). During a record review of Patient 2’s medical record form titled “Physician Order” dated from 1/18/2025, indicated Patient 2’s Enoxaparin and Sodium Chloride medications were to be discontinued. During a concurrent interview and record review on 1/31/2025 at 2 p.m., with DPCS of Patient 2’s EMR, the DPCS stated both of Patient 2’s medications, Enoxaparin and Sodium Chloride were to be discontinued on 1/18/2025 when the physician’s order was given. The DPCS stated Patient 2’s medication profile needed to be updated on the same day the order was given, 1/18/2025. The DPCS stated it was important to update Patient 2’s medication profile to prevent errors, and duplicate medications. The DPCS stated medication profiles need to be updated in case it needs to be sent to the patient’s physician. 3.A record review of Patient 6’s Patient Information sheet indicated a start of care date on 11/12/2024 with a primary diagnosis of encounter for surgical after care following surgery on the digestive system. During an observation on 1/29/2025, at 9 a.m., Licensed Vocational Nurse 1 (LVN 1) provided care to Patient 6. During a concurrent observation, interview, and record review on 1/29/2025, at 9:42 a.m., LVN 1 reviewed the medications Patient 6 was taking. The following medications were listed in Patient 6’s record titled, “Patient Medication Record”, dated 11/12/2024 to 1/10/2024, and Patient 6 stated she was no longer taking: Probiotic Product (a supplement) Senna-Docusate sodium (a stool softener) Trazadone hydrochloride (to treat depression). LVN 1 observed Patient 6’s medication bottles and labels. Patient 6 stated taking the following medications: Omeprazole (treats stomach upset) 20 mg (milligrams, mg-unit of measurement.) 1 capsule by mouth every day. The label indicated the medication was prescribed on 12/17/2024. Jardiance (treats diabetes-too much sugar in the blood) 10 mg, 1 tablet by mouth daily. Omeprazole and Jardiance were not listed in Patient 6’s “Patient Medication Record”, dated 11/12/2024 to 1/10/2024. 4.A record review of Patient 7’s Patient Information sheet indicated a start of care date on 12/21/2024 with a primary diagnosis of Type 2 diabetes (too much sugar in the blood) with foot ulcer (opening of the skin). During an observation on 1/29/2025, at 10:36 a.m., Licensed Vocational Nurse 3 (LVN 3), provided care to Patient 7. During a concurrent observation, interview, and record review on 1/29/2025, at 10:56 a.m., LVN 3 reviewed the medications Patient 7 was taking. The following medications were listed in Patient 7s record titled, “Medication Profile”, dated 12/21/2024 to 2/18/2025, and Patient 7 stated he was no longer taking: Famotidine (treats stomach upset) Mounjaro (injectable medicine for adults to treat type 2 diabetes) LVN 3 observed Patient 7’s medication bottles and labels. Patient 7 stated taking the following medications: these were not listed in Patient 7’s “Medication Profile”, dated 12/21/2024 to 2/18/2025: Humalog (insulin, a hormone/medication that regulates blood sugar levels) sliding scale (gives directions on how much insulin to give based on blood sugar levels): Blood sugar level of 150-200 =4 units. Blood sugar level of 201-250= 6 units. Blood sugar level 251-300= 8 units. EpiPen (used to treat allergic reactions). Ozempic (used to treat diabetes). LVN 3 observed Patient 7’s medication bottles and labels. Patient 7 stated taking the following medications: these medications had either the wrong dose or instructions listed in Patient 7’s “Medication Profile”, dated 12/21/2024 to 2/18/2025: Listed: Sildenafil Citrate (treats erectile dysfunction) Oral 20 mg 1 tablet by mouth daily as needed for high blood pressure. The label indicated to take 20-30 minutes prior to intercourse. Listed: Ibuprofen (pain medication) 800 mg 1 tablet by mouth daily as needed for mild pain. The label indicated to take twice a day Listed: Gabapentin (800 mg, 1 tablet by mouth daily. The label indicated to take 3 times a day. Listed: Lisinopril-hydrochlorothiazide 20-12.5 mg 1 tablet by mouth daily. The label indicted to take 30 minutes before breakfast on empty stomach. Listed: Pregabalin Oral 50 mg 1 capsule, take by mouth every 12 hours. The label indicated to take 75 mg every 8 hours. During an interview on 1/29/2025, at 11:15 a.m., LVN 3 stated whenever there is a new medication, she adds it to the electronic medical record (EMR). For existing medications, that need changes, she just tells the nurse because she doesn’t know how to update the changes in the EMR. LVN 3 stated she takes picture of the medication and reports it to the supervisor either the same day or the following day. LVN 3 stated she does not check the medication bottles and list every visit but does do it every 2 weeks. LVN 3 stated it was important to check the medications every visit to see if everything is correct, to see if they need refills. During an interview on 1/29/2025, at 11:15 a.m., Registered Nurse 3 (RN 3) stated that every visit the nurse had to look at the medication bottles and compare it to the list to make sure it was correct and matched. The importance of doing this was to avoid any adverse reactions, check for compliance and report to the doctor any changes. During a record review of HHA form titled “Medication Reconciliation” revised 4/2020, indicated “Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen.””

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on observation, interview and record review, the HHA staff failed to ensure the patients plan of care (POC) included pertinent clinical information and addressed these identified needs in the current plan of care for two of 17 sampled patients (Patient 3 and Patient 7). This failure had the potential to result in patients not receiving the identified needs and services, and have a decline in health status, that could affect their quality of care and well-being. 1. During a record review of Patient 3’s medical record form titled “Patient Information” indicated a start of care date of 11/3/2024. During a record review of Patient 3’s medical record form titled “Home Health and Plan of Care” dated from 1/2/2025 to 3/2/2025, indicated Patient 3’s primary diagnosis was infection following a procedure, other surgical site. The form also indicated Patient 3 was to have skilled nurse (SN) visits once a week for one week, then three times a week for eight weeks. Lastly, the form indicated Patient 3 had a wound care treatment to follow. During a record review of Patient 3’s medical record form titled “Physician Order” dated 1/10/2025, indicated Patient 3’s wound treatment was discontinued. During a record review of Patient 3’s medical record form titled “SN Frequency Change Order” dated 1/24/2025, indicated Patient 3’s SN visit frequency was changed to twice a week for five weeks. During a concurrent interview and record review on 1/31/2025 at 1:40 p.m. with the Director of Patient Care Services (DPCS) of Patient 3’s electronic medical record (EMR), the DPCS stated Patient 3’s individualized plan of care (POC) had not been changed or amended to note the change in SN frequency and the wound treatment status. The DPCS stated the HHA does not do amendments to the patients POC. The DPCS stated patients POC are followed by all the disciplines. 2. A record review of Patient 7’s Patient Information sheet indicated a start of care date on 12/21/2024 with a primary diagnosis of Type 2 diabetes (too much sugar in the blood) with foot ulcer (opening of the skin). During an interview on 1/29/2025, at 10:36 a.m., Patient 7 stated he had a history of sepsis (a life-threatening infection in the blood) and that experience was scary: to now he could die from it. Patient 7 stated a nurse visited him every Monday to give him antibiotics through his PICC line (PICC-Peripherally Inserted Central Catheter, a special tube inserted through the skin by means of the arm, that goes into a large vein near the heart.) The nurse who visited him was from a different agency. During a concurrent observation and interview of the home visit on 1/29/2025, at 10:54 a.m., Registered Nurse 3 (RN 3) observed Patient 7’s left upper arm. RN 3 stated Patient 7 had a PICC line on the upper left arm. During a concurrent interview and record review on 1/30/2025, at 1:32 p.m., the Director of Patient Care Services (DPCS), reviewed Patient 7’s record titled “OASIS-E Start of Care”, dated 12/21/2024. The DPCS stated Patient 7’s PICC line was identified on the initial comprehensive assessment done on 12/21/2024. The DPCS stated even though the HHA was not administering medications through the PICC line, the nurses could monitor it for signs of infection. If there was a problem, the nurse could notify the doctor, coordinate with the agency taking care of the PICC line, and report if there was something wrong with it. During a concurrent interview and record review on 1/30/2025, at 1:39 p.m., the DPCS, reviewed Patient 7’s plan of care titled, “Home Health Certification and Plan of Care”, dated 12/21/2024 to 2/18/2025. The DPCS stated she did not see anything that said the nurse needed to assess the PICC line. The interventions should be there because the nurse should know that it is part of the assessment. The nurse needed to know if there were signs of infection, to know it needed to be reported. If these interventions are in the plan of care, the nurse knows she is responsible for doing the assessment. During a record review of HHA form titled “Care Planning Process” revised 11/2020, indicated “The patient-specific clinical plan of care includes all pertinent diagnoses… frequency of visits, goals and interventions…medications, treatments… The plan of care will be based upon the physician’s orders and will encompass the equipment, supplies, and services required to meet the patients’ needs. The plan of care will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient. Revision dates will be noted on 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 interview and record review, the Home Health Agency (HHA) staff failed to notify the physician of the patient’s change of condition for one of 17 sample patients (Patient 9). This failure resulted in the patient’s physician not informed of patient’s progress or decline of his/her clinical status prolonging the patient’s certification to receive the home health benefits. A record review of Patient 9’s Patient Information sheet indicated a start of care date on 12/26/2024 with a primary diagnosis of encounter for aftercare following liver transplant. During an interview on 1/31/2025, at 12:42 p.m., Patient 9’s family member (FM 2) stated the nurse visited Patient 9 once a week and the nurse never did wound care. FM 2 stated the nurse just looked at the wound. FM 2 stated Patient 9 went to the doctor’s office last week and the doctor removed the scab on the belly. FM 2 stated the wound was healing and there were no issues with it. During a concurrent interview and record review on 1/31/2025, at 1:02 p.m., the Director of Patient Care Services (DPCS), reviewed Patient 9’s record titled, Visit Note dated 1/3/2025. The DPCS stated the document indicated the wound was closed. If the wound was closed, the nurse was supposed to notify the doctor and case management so an order can be obtained to discontinue the wound care. The DPCS stated there was no doctor’s orders to discontinue the wound care. The importance of notifying the doctor was so the doctor knows how the wound was doing, that it had closed. When the wound was closed, the doctor sometimes wants the HHA to monitor the wound even though it was closed. The nurse should have notified the HHA that the wound was closed. A review of Patient 9’s record titled, “Home Health Certification and Plan of Care”, dated 12/26/2024 to 2/23/2025, indicated, “Report to physician…any other significant changes.” During an interview on 1/31/2025, at 1:14 p.m., the DON stated that when the nurse identified that the wound was closed, the plan of care needed to be updated so the HHA knows if wound care was still needed.”

“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 observation, interview and record review, the Home Health Agency (HHA) failed to ensure two of 17 sampled patients (Patient 7 and Patient 9) received education and training regarding care and services identified in the plan of care. This failure resulted in putting patients at risks for injury and hospitalizations. 1. A record review of Patient 7’s Patient Information sheet indicated a start of care date on 12/21/2024 with a primary diagnosis of Type 2 diabetes (too much sugar in the blood) with foot ulcer (opening of the skin). During an interview on 1/29/2025, at 10:36 a.m., Patient 7 stated he had a history of sepsis (a life-threatening infection in the blood) and that experience was scary, to know he could die from it. During an observation of the home visit on 1/29/2025, at 10:45 a.m., Licensed Vocational Nurse 3 (LVN 3), provided wound care to Patient 7. Patient 7 stated he learned how to do wound care in the hospital. Patient 7 stated wound care was supposed to be done 2 to 3 times a week. During the visit, LVN 3 did not teach Patient 7 how to do the wound care. During a concurrent interview and record review on 1/30/2025, at 1:45 p.m., the Director of Patient Care Services (DPCS), reviewed Patient 7’s plan of care titled, “Home Health Certification and Plan of Care”, dated 12/21/2024 to 2/18/2025. The record indicated, “SN (skilled nurse) to instruct Patient/Caregiver on wound care as follows....To be performed daily.” The DPCS stated the nurse was supposed to instruct the patient and/or caregiver about daily wound care every visit. During a concurrent interview and record review on 1/30/2025, at 1:45 p.m., the DPCS, reviewed Patient 7’s visit notes dated 1/1/2025, 1/3/2025, 1/6/2025, 1/8/2025, 1/10/25, 1/13/25, 1/14/25, 1/17/25, 1/23/25, 1/24/25, and 1/28/25. The DPCS stated she could not find anything that said Patient 7 was instructed to do wound care. There was no documented evidence the nurse taught the patient or care giver. The DPCS stated the notes needed to specify that the nurse instructed on the wound care and frequency of wound care. This was important to know what the situation was. Maybe the nurse did teach the patient how to do it, and patient is refusing or needing more teaching. We could notify the doctor about it. When asked what can happen if the patient is not doing daily wound treatment as ordered, the DPCS stated the wound can deteriorate, get infected, which could cause Patient 7 to go back to the hospital. 2. A record review of Patient 9’s Patient Information sheet indicated a start of care date on 12/26/2024 with a primary diagnosis of encounter for aftercare following liver transplant. During an interview on 1/31/2025, at 12:42 p.m., Patient 9’s family member (FM 2) stated the nurse visited Patient 9 once a week and the nurse never did wound care. FM 2 stated the nurse just looked at the wound. FM 2 stated Patient 9 went to the doctor’s office last week and the doctor removed the scab on the belly. During a concurrent interview and record review on 1/31/2025, at 1:02 p.m., the DPCS reviewed Patient 9’s record titled, “Home Health Certification and Plan of Care”, dated 12/26/2024 to 2/23/2024. The record indicated, “SN to instruct patient/caregiver on wound care as follows: Perform instruct wound care to abdominal incision wash with soap and water daily pat dry leave open to air daily. Caregiver to perform wound care on non-skilled nurse visit days.” The DPCS further reviewed Patient 9’s visit note dated 1/3/2025 and stated the document did not indicate that the wound care was done, nor the patient was instructed to do wound care. During a concurrent interview and record review on 1/31/2025, at 1:08 p.m., the DPCS reviewed Patient 9’s visit notes of 1/11/2025. The DPCS stated the note did not indicate the nurse instructed the patient/caregiver to perform daily wound care when the nurse did not visit. During a concurrent interview and record review on 1/31/2025, at 1:13 p.m., the DPCS reviewed Patient 9’s visit notes of 1/24/2025. The DPCS stated there was no documentation that the nurse instructed the patient/caregiver to perform daily wound care when nurse didn’t come. During a record review of HHA form titled “Patient Education” revised 4/2020, indicated “Patients and family/caregivers will receive education in verbal, and written format, as appropriate.” During a record review of HHA form titled “Patient Education” revised 4/2020, indicated “Patients and family/caregivers will receive education in verbal, and written format, as appropriate.””

“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 interview and record review the Home Health Agency (HHA) staff failed to ensure the clinical record contained completed clinical notes one of 17 sampled patients (Patient 9). This failure resulted in the lack of coordination of the care and services provided to the patient among the HHA staff. A record review of Patient 9’s Patient Information sheet indicated a start of care date on 12/26/2024 with a primary diagnosis of encounter for aftercare following liver transplant. During an interview on 1/31/25 at 1:18 p.m., the Director of Patient Care Services (DPCS) reviewed the referral order and stated Patient 9 should have been seen by Physical Therapy (PT) for evaluation, within 48 hours of start of care, by 12/28/2024. The DPCS stated Patient 9 was seen on 1/3/2025. The DPCS stated there was no note in Patient 9’s record to specify why the PT evaluation was done late. The importance of the PT evaluation to be done within 48 hours was to do the home safety assessment to prevent falls, and deterioration. If patient is not seen within 48 hours, the doctor has to be notified why the evaluation was late. During an interview on 1/31/25 at 2 p.m., the DPCS stated the PT order to explain why the PT evaluation was late was not uploaded into the medical record. During a record review of HHA form titled “Entries into the Clinical Record” revised 4/2014, indicted “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided.””