Every finding on record at Adara Home Health Inc

On 1/14/24 through 1/16/24 a complaint survey was conducted. This resulted in a partial extended survey at Adara Home Health Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency's inability to ensure provision of quality of care.

Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review the facility failed to notify the physician on missed medications for 1 of 3 clients (C1) reviewed who did not receive prescribed Venlafexine (used to treat depression, general anxiety disorder, social anxiety disorder, and panic disorder) resulting in in-patient hospitalization. Findings included: P1's Home Health Certification and Plan of Care for certification period 12/26/24 through 2/23/25, identified diagnosis that included Bipolar Disorder, Attention Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, and mood disorder. The Plan of Care indicated skilled nurse visits weekly for eight weeks and indicated nurse would fill Medi-Planner per medication orders profile weekly. P1's Plan of Care identified an order for Venlafexine 150 milligram capsule, extended release. Take two capsules by mouth daily. P1's Visit Note Reports and Client Coordination Notes identified the following: 12/24/24, visit note indicated P1's medications set up as ordered in dose health machines for her to administer. Medications reviewed and reconciled. Medications set up through 1/6/25. Missing six days of venlafexine. 12/31/24, Visit note indicated medication set up per orders. Several medications missing. These were recorded and communicated to the client. 1/6/25, coordination note indicated call from visiting nurse who reported P1 had stated her mental health was not doing well and she was suicidal. 911 was called to reported concerns and request well check. Case manager scheduled to visit client tomorrow. 1/8/25, Visit note indicated P1 picked up medications from pharmacy but missing medications. Boxes filled with what was on hand. 1/8/25, coordination notes indicated agency nurse spoke with mental health provider about P1 suicidal ideations and vulnerable adult filed. Seven doses of missed mediations due to difficulty with refills through pharmacy related to authorization needed. 1/9/25, coordination noted indicated police department called agency and reported P1 told him she had spoken to her case manager and had a plan in place to help her. Writer explained agency was case managing and had suggested P1 be evaluated in the emergency department (ED) due to concerns of suicidal ideation and that she had not taken necessary mental health medication in the last week. Writer called client who agreed to be seen in the ED. During interview on 1/15/25 at 9:02 a.m., the area manager stated P1 was supposed to have her Venlafexine and said the medication had been filled through 12/31/24. The area manager stated staff should have notified the physician when a medication was not available and stated the notification should have been documented. During interview on 1/15/25 at 11:26 a.m., registered nurse (RN)-A stated she had visited P1 in the home on 12/31/24. RN-A stated she did admissions and would occasionally pick up a home visit when needed. RN-A stated "I imagine there were several medications missing" during the visit. RN-A said if medications were not available, she would typically notify the provider. RN-A stated she did not remember if she notified the provider that day and said she should have. Facility Policy Coordination of Care/Services dated 9/10/24, indicated the company will notify the primary physician/non-physician practitioner associated with the relevant aspect of home care with a change in client condition, as appropriate.

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 11/12/24 to 11/15/24, during a recertification survey. The facility is in compliance with the Appendix Z Emergency Preparedness Requirements.

On 11/12/24 to 11/15/24 a recertification and complaint survey was conducted. This resulted in a partial extended survey at Adara Home Health Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Unduplicated census previous 12 months: 5050 Total home visits conducted: 7 Parent Location visit: Buffalo: 25 1st Ave NE Suite 100, Buffalo, MN 55313 Branches Visited: Rochester: 230 20th Ave SW Suite 101, Rochester, MN 55902 Hutchinson: 246 Main St S, Hutchinson, MN 55350 St. Joseph: 710 County Road 75 E Suite 104, St. Joseph, MN 56374 Branches not visited: Blaine: 10141 University Ave NE Suite 300, Blaine, MN 55434 Mendota Heights: 1333 Northland Drive Suite 225, Mendota Heights, MN 55120 Records Reviewed from remaining branches: Mankato: 1961 Premier Drive Suite 340, Mankato, MN 56001 List Hours of Operation: 8:00 a.m. - 5:00 p.m. List total number of records reviewed: 18 The following complaints were reviewed: H80561195C (Inc 110554) H80561261C (Inc 109598) H80561194C (Comp 107830) H80561196C (Inc 102419) H80561197C (Inc 101849) H80561198C (Inc 101593) H80561199C (Comp 100870) H80561280C (Inc 96970) H80561281C (Comp 95335) H80561283C (Inc 71747) H80561282C (Comp 71749) H80561195C (Comp 110613) H80561195C (Comp 110597)

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to timely encode and submit Outcome and Assessment Information Set (OASIS) in accordance with Center for Medicare (CMS) requirement. On the HHA Error Summary by Agency report with run date of 11/8/24, the agency had an error code of -3330: record submitted Late. The description included was the submission date was more than 30 days after M0090 on the new record. The report included the number of assessments with this error code was 204, which equaled a percentage of 0.92% of submissions with this error code. During interview on 11/14/24 at 12:45 p.m., clinical manager (CM)-D stated the agency used an automated process to submit OASIS data once the assessment was closed. They occasionally got error codes, which they would address the following day. CM-D stated she was aware some OASIS data was transmitted late due to a change in payor source or other coding errors which required resubmission past the allowed time frame. The agency reported they did not have a policy on submission of OASIS data but followed CMS guidelines.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency failed to ensure all medications were not expired during medication set up for 1 of 2 patients (R4) who was observed during a home visit. P4’s plan of care (POC) for certification period 9/15/24 to 11/13/24, indicated P4’s diagnosis included polyarthritis, anxiety, and bipolar disorder. POC included a comprehensive medication list and orders for weekly medication set up. During home visit on 11/13/24 at 10:00 a.m., registered nurse (RN)-A was observed setting up P4's medications in a weekly planner. Included in medication set up were hydroxychloroquine 200 milligrams (mg) one tab twice a day, metoprolol tartrate (medication to lower blood pressure and pulse) 25 mg 1/2 tab twice a day. Upon completion of medication set up by RN-A, review of medication bottle labels was completed by surveyor. This review revealed hydroxychloroquine had a discard date of 11/7/24 and metoprolol tartrate had a discard date of 5/1/23. During interview on 11/13/24 at 10:30 a.m., RN-A stated she did not typically check medication expiration dates or discard by dates on the labels while doing medication set up as she calls in the refills for the medications, so was confident the medications were used up prior to the discard date. RN-A reviewed both medication labels and confirmed the discard date had passed. RN-A stated the medication should not have been set up due to the discharge date being passed. During interview on 11/14/24 at 2:00 p.m., clinical manager (CM)-A stated all nurses are educated on medication set up prior to completing home visits. They were instructed to check each medication label each set up, including the expiration date. CM-A stated the nurse should have called the provider for clarification while in the home if a medication is expired and there were no additional medications in the home. CM-A stated a medication past the discard date should not have been used because potency of medications could change after they are expired. During interview on 11/14/24 at 2:50 p.m., branch CM-B stated nurses were trained during orientation on how to set up medication in the home. She expected nurses to follow the rights of medication set up, this included checking for expiration dates. CM-B stated a medication should not have been set up after the discard date and a new medication should have been ordered from the pharmacy prior to set up. Facility policy for medication set up dated 10/9/23, included each medication should be reviewed and the label should be compared to the written order. The details to be reviewed included expiration date.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency also failed to assure the medication profile was reconciled with routine visits for 1 of 2 patients (P6) reviewed for wound care observation. The agency also failed to include ostomy assessment, education, and management of ostomy care for 1 of 3 patients (P7) reviewed for plan of care. P7's start of care (SOC) to the agency was 10/28/24, with diagnoses of diverticulitis of large intestine with perforation and abscess, chronic obstructive pulmonary disease, pulmonary hypertension, colostomy, pneumonia, and acute on chronic respiratory failure. P7's POC had certification dates of 10/28/24 to 12/26/24 signed by physician 11/6/24. P7's POC included orders, "Skilled nurse for observation/assessment of gastrointestinal status and to intervene to minimize complications. Skilled nurse to provide skilled teaching/reinforcement related to altered gastrointestinal status including pathophysiology, nutritional requirements, and medication regimen." P7's hospital discharge summary dated 10/25/24 identified, "DME OSTOMY SUPPLIES, DME OXYGEN". P7's after visit summary dated 10/26/24 identified, "Pick up these medications from any pharmacy with your printed prescription" with "DME Ostomy supplies" listed. In addition, Skin/Wound/Dressing Care describes, "Ostomy Care: LLQ end colostomy is red and budded and measures 1-1/4". Sutures are intact around the stoma. Peristomal skin is good. The patient is wearing Hollister wafer #14905, with Hollister #7805 moldable barrier stretched and placed around the opening of the adhesive side of the wafer, and Hollister #18133 drainable pouch. After the stool becomes formed the patient may choose to use the closed end pouches (Hollister #18393 7" or #18373 9"). The pouching system should be changed twice a week. The patient has a box of supplies, a folder with written information including a supply list for ordering purposes." Medication List identifies, Start "DME Ostomy supplies". P7's home care observation visit on 11/13/24 at 11:30 a.m., P7 stated, "I was sent home from the hospital with the Ostomy supplies". One cardboard box of Ostomy supplies including wafers, barriers, and pouches were on a wooden television tray in living room within reach of P7 who was sitting in recliner chair. P7 stated, "I was taught how to change the ostomy. They [pointing to registered nurse (RN)-A] help me with putting it on since have to lay down flat and can't see it very well. I get the stuff (pointing to the Ostomy supplies) ready before they come, and they will hold it in place after I put the putty on around my stoma." During interview with RN-A on 11/13/24 at 12:15 p.m., RN-A stated, Ostomy orders are not in the plan because she [P7] manages and does the dressing changes. I hold the ostomy apparatus down on her stomach and help attach it when she is laying down flat. [P7] can't see it very well so I help her. I use my hands to hold it down over the stoma. Ostomy supplies are not on the DME because she manages it and we do not. During interview with clinical supervisor (CS) on 1114/24 at 11:31 a.m., CS stated the P7 POC, "is current" and "The Ostomy supplies should also be listed in the DME. Even if she is managing the oxygen supplies an ostomy supplies it should still be on the DMR. If our staff lay hands on her to assist with the Ostomy placement then that should be on the care plan." After reviewing P7's care plan SC stated, "it is not". Facility policy titled INITIAL ASSESSMENT/CERTIFICATION revised 12-29-23 identify "assessments are appropriate to the type of services provided by the company, where services are provided, and the client's need." "G. Equipment presently in home and potentially needed by client" and "N. Specific, individualized client's needs/problems pertinent to the care being provided". P6's Home Health Certification and Plan of Care, identified P6's start of care was 2/16/24. P6's Home Health Certification and Plan of Care, with a recertification period form 10/13/24 to 12/11/24, indicated P6's medical diagnoses included varicose veins of the left and right lower extremity with ulcer other part of the lower leg, non-pressure chronic ulcers of the lower legs, peripheral vascular disease (slow and progressive disorder of the blood vessels), radiculopathy (a pinched nerve which causes pain, numbness, and tingling along the nerve pathway) in the lumbosacral (lower back) region, and chronic pain. P6's orders included skilled nursing visits (SNV) three times a week for provision of wound care to non-pressure ulcers on the lower legs. In addition to provision of wound care, the skilled nurse was to review medication profile and reconcile medications as needed. Additionally, the skilled nurse may instruct and reinforce medication teaching related to use of medications to treat disease process and educate on all special precautions. On 11/13/24, at 3:15 p.m. wound care observation was completed with registered nurse (RN)-C at patient's home. Following the provision of wound care, assessment was completed in follow up for overall well-being. During this time, RN-C inquired of resident if they had been to the doctor in follow up, and if there were any changes to medications. P6 stated there were no changes. A review was completed with P6 to determine supplies for wound care was needed. P6 stated she was awaiting dressings, as well as prescriptions from the pharmacy. Upon verification of completion of assessments and visit, medication reconciliation of med listing on Plan of Care was initiated at this time by surveyor. P6 stated she no longer used the loratadine 10 mg daily as this had been discontinued by the primary doctor approximately four to six weeks ago due to dry skin. P6 stated she no longer was taking the pregabalin (Lyrica) 10 mg and had stopped using four weeks ago per the primary doctor recommendation. P6 stated she used an eye drop called Soothe XP as needed three to four times a day for dry eyes. P6 stated she was going on her third round of treatment for "pink eye". A review of the prescription bottle for the pink eye identified the medication as Gentamicin Sulfate one drop every four hours while awake for seven days. The original date of dispensing medication was 8/19/24. P6 stated this had been authorized for refills on three occasions. RN-C stated she was unaware of the changes identified and planned to follow up with the provider to determine what orders were to be in place. A review of records for visits from 10/13/24 to 12/11/24, was completed. Upon review of the visit notes, it was noted the staff routinely inquired of client if she had any physician/non-physician practitioner visits since the last home visit. On 10/18/24, RN-D identified P6 had been seen by the by the provider since the last SNV. The record prompt indicated: Obtain order to put into medical records as appropriate. Upon review of the narrative notes within the assessment, it identified P6 had an eye appointment earlier, however, there was no indication as to what the visit was for, or what the change of orders were. A review of the assessments and narrative notes was completed from the start of the last recertification period 10/13/24. The documentation reflected the following assessment for eyes/ears/nose throat: Indicate eyes/ears/nose/throat findings. The notations of 10/14/24, 10/23/24, and 10/30/24 identified only: Eyeglasses. Hard of hearing. The documentation of 10/18/24, 10/21/24, 10/25/24, 10/28/24, 11/1/24, 11/4/24, 11/6/24, 11/8/24 and 11/13/24 indicated only eyeglasses. The documentation lacked documentation of eye appearance/condition. A review of the narrative notes within the assessment for 10/18/24 indicated P6 was seen for an eye appointment, however, lacked purpose of the eye appointment (eye exam, pink eye, glasses dispensed...). Although RN-D identified P6 was seen for an appointment on 10/18/24, the only finding noted in the assessment was the fact P6 had eyeglasses. A review of the narrative note section within the assessment made the following reference to the use of pregabalin (Lyrica) 10 mg and Tylenol for pain management on 10/14/24 and 10/16/24. On 10/18/24, RN-D documented in the narrative notes patient was advised to decrease Tylenol, Lyrica, and antihistamines. RN-D indicated the teaching performed for P6 to continue to take Tylenol and Lyrica as needed, with non-pharmacological interventions. The narrative note lacked follow up with the provider to verify desired plan for Tylenol, Lyrica, or antihistamine use. The narrative note of 10/21/24, indicated the patient continued to taper off scheduled medications and used as needed. On 10/23/24, it was identified P6 continued to use Tylenol, as needed, with Lyrica. The narrative note indicated P6 was weaning Tylenol due to liver concerns. On 10/25/24, there were no changes in pain management documented. On 10/30/24, the documentation identified P6 continued to use Tylenol, as needed, with Lyrica. The subsequent documentation lacked reference of specific medications used for pain management. A review of the pain assessments completed with the SNVs through 11/13/24, identified medications were used as an effective pain management intervention in all narrative notes, except of documentation of 11/1/24 which indicated P6 had no pain. Although there had been discussion of the taper of Tylenol, Lyrica, and antihistamines in the narrative, the documentation lacked indication of verification with the provider regarding this. On 11/15/24, at 9:40 a.m. the clinical manager (CM)-E stated medication reconciliation should be completed with every visit. CM-E stated this was achieved by asking the patient if there were any changes, follow up with providers after known appointments, and with routine recertification periods. The facility policy, Medication Management, revised 5/17/24, identified if a new and/or changed medication is prescribed during the certification period, a verbal order will be obtained from the physician to confirm the additional/changed medications, and update the Medication Profile. The policy also identified if a medication was discontinued, the clinician will call the provider to confirm the change, write a verbal order, and update the Medication Profile.

On 7/25/24 – 8/7/24 a complaint survey was conducted. This resulted in an extended survey at Adara Home Health Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. The following complaints were reviewed: H80566220C/MN108375 The Condition of Participation: Care planning, Coordination of Services and Quality of Care Services at 42 CFR 484.60 at G570 was found not met.

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 number and/or of the deficiencies cited, the home health agency (HHA) failed to meet the Condition of Participation: Care planning, Coordination of Services and Quality of Care Services at 42 CFR 484.60. The agency failed to provide safe skilled nursing services to monitor the patients skin who had worsening of pressure ulcers, identify durable medical equipment (DME), and provide caregiver education. Findings include: Refer to G572 - Based on interview and record review the home health agency (HHA) failed to effectively provide safe skilled nursing services within the patient’s home for 1 of 3 patients (P1) when the HHA was did not adequately monitor changes of wounds and did not notify P1’s physician when the plan of care was not followed. P1 was receiving weekly skilled nursing visits. The HHA was to be assessing P1’s skin integrity, while P1’s caregivers provided wound care. P1’s chronic bilateral hip ulcers changed from stage 2, and unstageable to stage 4 pressure ulcers after a bowel resection surgery left P1 malnourished with frequent ostomy leakage. Refer to G574 – Based on observation, interview, and record review the home health agency (HHA) failed to include durable medical equipment (DME) on the plan of care (POC) for 12 of 17 patients (P1, P2, P3, P4, P8, P9, P12, P13, P14, P15, P16, P17) reviewed for the individual plan of care. In addition, the HHA failed to provide caregiver education with an acceptable standard for practice for 1 of 17 patients (P1) reviewed.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to effectively provide safe skilled nursing services within the patient’s home for 1 of 3 patients (P1) when the HHA was did not adequately monitor changes of wounds and did not notify P1’s physician when the plan of care was not followed. P1 was receiving weekly skilled nursing visits. The HHA was to be assessing P1’s skin integrity, while P1’s caregivers provided wound care. P1’s chronic bilateral hip ulcers changed from stage 2, and unstageable to stage 4 pressure ulcers after a bowel resection surgery left P1 malnourished with frequent ostomy leakage. Findings include: Hospital Wound/Skin Assessment dated 4/9/24 indicated P1 had community acquired bilateral hip pressure ulcers (P/U). P1’s left hip P/U was unstageable with a greater area of 1-2 centimeters (cm). The unstageable area measured 5 cm. x 3 cm. x 0.4 cm. (length x width x depth) covered in whitish slough with a darker area in the center. P1’s right hip P/U was healing, was unstageable with a large area of resolved scar tissue 8 cm. 12 cm. with two open areas. P1’s Home Health Certification and Plan of Care dated 5/15/24 to 7/13/24 indicated P1’s pertinent diagnoses were: -Arnold Chiari syndrome with spina bifida and hydrocephalus (a congenital condition in which the brain tissue extends into the spinal cord), Stage II pressure ulcers to the right and left hips, severe protein calorie malnutrition, epilepsy (nerve cell activity in the brain which cause seizures), asthma, anxiety and depression, acute kidney failure, sarcoidosis of the lung (an auto-immune disorder causing inflammation), dysphagia oropharyngeal phase (swallowing problems) and a history of thrombosis and embolism (blood clots). -P1 had a urinary catheter, ileostomy (a procedure in which a lumen is placed, that a person evacuates stool from), a Hickman catheter (a long term, central venous catheter placed in a large vein for easy access to blood draws or intravenous medications), oxygen therapy and was wheelchair bound. Orders of Discipline and treatment: -Care givers provide daily wound care to bilateral hips. Wound care to right and left hip. 1. Cleanse with normal saline, pat dry. 2. Skin prep entire area. 3. Light smear of Idiosorb gel to open area. 4. Cover with Mepilex foam border. -Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. Skilled nurse to provide skilled teaching related to altered skin integrity including pathophysiology, nutrition, medication regimen, and permitted activity. Skilled nurse to report significant changes in status to physician for early intervention. Goals/Rehabilitation Potential/Discharge Plans: -Patient/Caregiver will verbalize/demonstrate ability to perform wound care, wound status will improve as evidence by a decrease in size, drainage, absence of infection and decreased pain by end of episode. P1’s HHA Wound Report dated 3/30/24 – 6/25/25 indicated: -On 3/30/24 at 2: 17 p.m. P1 had a Stage II pressure ulcer (P/U) to the right hip measuring 2.5 centimeters (cm) in length x 7 cm. in width x 0.1 cm in depth the total surface area was 17.5 cm. P1’s left hip had a Stage II pressure ulcer measuring 2 cm x cm x 0.1 cm. with a total surface area of 6 cm. -On 4/5/24 at 4:00 p.m. P1’s P/U’s were not assessed and care was refused. -On 4/18/24 at 12:34 p.m. P1’s P/U’s were not assessed, and care was refused. -On 4/24/24 at 12:46 p.m. the right hip P/U measured 3.5 cm. x 3 cm. x 0.5 cm total surface area 10.5 cm. The left hip P/U measured 10 cm. x 6 cm. x 1 cm. total surface area 60 cm. -On 4/30/24 at 1:45 p.m. P1’s P/U’s were not assessed, and the caregiver (family) completed the care. -On 5/7/24 at 11:20 a.m. P1’s right hip was 2 cm. x 2 cm. x 2 cm. total surface area 4 cm. The left hip P/U measured 3 cm. x 2 cm. x 2 cm. -On 5/14/24 at 12:03 p.m. P1 P/U’s were not assessed the caregiver (family) completed the care. -On 5/19/24 at 12:08 p.m. P1’s P/U’s were not assessed, not ordered this visit. -On 5/28/24 at 12:07 p.m. P1’s P/U’s were not assessed the caregiver (family) completed cares. -On 6/4/24 at 12:11 p.m. P1’s P/U’s were not assessed the family caregiver completed cares. -On 6/11/24 at 12:16 p.m. P1's P/U’s were not assessed the family caregiver completed cares. -On 6/18/24 at 11:53 a.m. P1’s right P/U measured 7 cm. x 7 cm. x 2 cm. total surface area 49 cm. The left P/U was not assessed, the caregiver completed cares. -On 6/25/25 at 1:26 p.m. P1’s P/U’s were not assessed the family caregiver completed the care. The report indicated the left hip P/U was assessed. Inactivated – healed. Emergency Medicine Staff Physician note dated 6/25/24 at 8:03 p.m. indicated P1’s chief complaint for presenting to the emergency department was her Hickman Catheter coming off. P1 had been seen 6/24/24 at her local emergency department. P1 was noted to have had a febrile illness. P1 had two open ulcerative wounds, which did not appear grossly infected, but the hip wound was deep with drainage, therefore infection could not be ruled out. The recommendation was for P1 to transfer to the larger hospital due to P1’s complexity, history of multi-drug resistant bacteremia, and the need for complex wound management. P1’s family member took P1 home against medical advice from the local ER visit on 6/24/24. On 6/25/24 the family was notified P1’s blood cultures showed gram negative rods (bacteria that causes infections such as pneumonia, bloodstream infections, wound or surgical site infections). P1 presented to the larger hospital emergency department on 6/25/24 admitted at 11:44 p.m. with sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present. P1’s admitting diagnoses included right hip ulceration, sepsis, bacteremia, urinary tract infection and anemia. Hospital note dated 7/02/24 at 3:37 p.m. indicated P1 was admitted to the hospital with bacteremia with gram negative rods. The wound team and general surgery was consulted for deep wounds. Surgery did not feel any surgical debridement was indicated and recommended wound cares; no wound vacuum (a device used to assist closure of wounds) given due to P1 having bone exposure. The orthopedic team was consulted regarding the osteomyelitis but felt P1 was not a candidate for a flap closure. The Pallative Care Team was consulted to review goals of care in a clinically complex patient with large nonhealing wounds with malnutrition. P1’s hospital care conference note dated 7/5/24 indicated P1 had failed management at home with weight loss and worsening wounds. P1 needed a better home mattress to offload wounds and will need home nursing to help with wound cares (was not consistently getting as an outpatient). P1’s hospital death note dated 7/15/24 at 2:52 a.m. indicated P1’s cause of death was: 1. Acute hypoxic and hypercapnic respiratory failure due to pneumonia. 2. Severe sepsis due to recurrent Klebsiella bacteremia. 3 Osteomyelitis due to multiple decubitus ulcer. 4. Spina bifida complicated by hydrocephalus, neurogenic bowel and bladder, spastic paraplegia. Upon interview on 7/26/24 at 10:37 a.m. P1’s family member (FM)-A, also P1’s care giver from a non-skilled home agency stated the HHA had weekly nursing visits with P1. The visits were to change the dressing and assess P1’s Hickman catheter and to assess her health, including the status of her pressure ulcers. FM-A stated P1 would wake-up early in the mornings and the family care giver would change the dressings on her hips because they were soaked from a leaking ostomy overnight. She stated the HHA would not remove the dressing during the nursing visits, the staff would ask the family how the wounds were doing rather than viewing the wounds. Upon interview on 7/26/24 at 11:39 a.m. RN-C stated she would attempt to monitor P1’s wounds during the nursing visits, but the family refused. The family would provide the wound care prior to the nursing visits. RN-C stated on 7/18/24 she was able to visualize the wound on the right hip, and she stated she asked the family if they wanted orders for a wound clinic due to wound deterioration. RN-C denied reaching out to P1’s provider stating she offered but, “The grandma is her PCA (patient care aide) and said she contacts the physician often.” Upon interview on 7/26/24 at 12:47 a.m. P1’s primary care provider’s clinical registered nurse, (RN)-B stated the clinic did not receive any update from the HHA regarding the family refusing to allow the staff to visualize the P/U’s or any notification that the P/U’s had worsened. Upon interview on 7/26/24 at 1:50 p.m. RN-E, an area manager stated her expectation of the nursing staff was if the HHA was overseeing and managing the wound then the visit nurses should be notifying the provider. Upon interview on 7/26/24 at 2:06 p.m. RN-D, a clinical supervisor stated the HHA was providing Hickman catheter cares and lab draws for P1. She stated if the staff is aware of a wound her expectation is that the staff are looking and measuring the wound. RN-D stated if the staff is unable to perform assessments or assess worsening of a wound the patient’s provider should be notified. Upon interview on 7/29/24 at 11:49 a.m. P1’s Primary Care Physician (PCP) stated she was aware P1 had skilled nursing services in the home. She stated she had only seen P1 over video because of the difficulty to get P1 to visits, therefore she relied on the HHA for updates. She was aware of P1’s hospital admits and that P1 had wounds. She stated the first she heard of the wounds worsening was a note from P1’s local emergency department on 6/24/24 where it was documented P1 had severe wounds on her hips bilaterally with possible infection with the recommendation to transfer to the largest hospital. The PCP stated if she would have been aware that P1’s family was refusing the skilled nursing staff to assess P1’s P/U’s she would have had a discussion with the family or changed services to add more or different services that met P1’s needs in the home. Upon interview on 7/30/24 at 10:48 a.m. Hospital Physician (MD)-A stated P1 had a complicated urinary conduit surgery in 2023 which resulted in a bowel resection which led to short gut. With a short gut P1 had an inability to absorb nutrients therefore healing of wounds was incredibly difficult. The bacteria P1 had was Klebsiella which is the same microbes in the stool and were found in the wounds. She had bacteremia which means the bacteria was throughout her body via her blood. P1 was started on total parental nutrition TPN (IV administered nutrition) on 7/5/24 which would have helped with her absorbing nutrients, but the wounds were “probably” too deeply infected at that time. The infection “more than likely” did start in the wounds and progressively got worse. She stated she didn’t know what P1’s discharge orders back in 4/2024 were, but P1 required professional wound care and if that was not feasible a close eye on assessing those wounds. During P1’s hospital stay P1 had a seizure and a mild MI. P1 was admitted to the ICU and awoke, but she ultimately passed as she became more septic in her lungs, they were completely infected with the Klebsiella bacteria leading to acute respiratory distress (ARD) syndrome, that is when the lungs are completely filled with infectious fluid and unable to work properly to sustain life. Upon interview on 8/2/24 at 4:30 p.m. Hospital Physician (MD)-B stated P1 was a difficult patient, and he knew the family well. P1 had spina bifida, she had a surgery in 2023. The surgery took part of her small intestines and that left her with short gut, which basically ends up in dumping, so she could not absorb nutrition. P1 went from stage 1-2 P/U and an unstable P/U on her hips bilaterally to stage 4 in the matter of “about” 6 weeks, the hospital providers were alarmed. P1 was prone to pressure ulcers with her conditions. P1’s family lives in rural Minnesota with limited resources. “I don’t think they understand her cares fully.” The key with P/U’s is dressing changes and turning and repositioning often. P1 had no sensation below the waist so she was unable to feel the P/U’s. P1 was 21 years old and was obstinate, her demeanor was that more of 6 years old. Family had good intentions but were not trained to be skilled caregivers. “I was not aware that skilled nursing was in the home assisting with education, dressing changes and assessments.” MD-B stated the HHA needed to escalate the refusals and the changes in her P/U’s. “Her death could have been prevented at this time. I can’t say that in the long term because of her medical status. If the skilled nurses would have escalated refusals or changes in wound status plastic surgery could have formed a flap from her back around over her hips bilaterally. We had multiple discussions with plastics. She was definitely mismanaged in the home.” An agency policy titled Informed consent/refusal of treatment revision date 12/29/23 indicated: The client is informed of expected consequences whenever any treatment/service is refused. Clinical documentation of such refusals include: date/time of the visit and/or phone contact, specific treatment being refused., description of what was explained to the client regarding consequences of decision, the date and time of the physician contact, action to be taken per the physician, client response after explanations.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the home health agency (HHA) failed to include durable medical equipment (DME) on the plan of care (POC) for 12 of 17 patients (P1, P2, P3, P4, P8, P9, P12, P13, P14, P15, P16, P17) reviewed for the individual plan of care. In addition, the HHA failed to provide caregiver education with an acceptable standard for practice related to wounds for 1 of 17 patients (P1) reviewed. Findings include: P1’s Home Health Certification and Plan of Care (POC) dated 5/15/24 to 7/13/24 indicated P1’s pertinent diagnoses were: Arnold Chiari syndrome with spina bifida and hydrocephalus (a congenital condition in which the brain tissue extends into the spinal cord), Stage II pressure ulcers to the right and left hips, severe protein calorie malnutrition, epilepsy (nerve cell activity in the brain which cause seizures), asthma, anxiety and depression, acute kidney failure, sarcoidosis of the lung (an auto-immune disorder causing inflammation), dysphagia oropharyngeal phase (swallowing problems) and a history of thrombosis and embolism (blood clots). P1 had a urinary catheter, ileostomy (a procedure in which a lumen is placed, that a person evacuates stool from), a Hickman catheter (a long term, central venous catheter placed in a large vein for easy access to blood draws or intravenous medications), oxygen therapy and was wheelchair bound. P1’s durable medication equipment (DME) supplies identified were a wheelchair and a hospital bed. The POC failed to include P1’s urinary and Hickman catheter supplies, ileostomy supplies and oxygen and supplies. P1 received skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. Skilled nurse to provide skilled teaching related to altered skin integrity including pathophysiology, nutrition, medication regimen, and permitted activities. Skilled nurse to report significant changes in status to physician for early intervention. The POC did not indicate the skilled nurse would educate the caregiver (family) on completing the dressing change to acceptable standards of practice. P1's nursing visit note dated 3/30/24 indicated P1 had two new pressure ulcers, the wound care provided was skilled nurse to perform/teach pressure ulcer care to right and left hips. Cleanse with normal saline. Pat dry. Apply Triad paste to the wound bed and cover with Mepilex foam dressing. Family to assist with dressing changes. The note did not indicate the education provided to the family. P1's nursing note dated 4/5/24 did not indicate any education provided to the family. P1's nursing note dated 4/10/24 did not indicate any education provided to the family. P1's nursing note dated 4/18/24 (a recertification visit) indicated education was provided to the caregiver (family) and the caregiver verbalized understanding. The education indicated the patient/caregiver was instructed on the pathophysiology related to skin breakdown, the definition of skin breakdown, changes to intact skin, including non-blanchable erythema without overlying tissue loss, abrasion, mild entry into the skin, and deep and extensive pressure ulcers and infection signs and symptoms. The education did not indicate the specific dressing change including infection control provided to P1. P1's nursing note dated 4/23/24 indicated the nurse provided basic instruction for patient caregiver on factors to prevent pressure ulcers. The note did not indicate the factors of the basic instructions. In addition, education was provided for signs of symptoms of skin breakdown including pale or reddened area, blister, pain, itching, boggy area, and loss of tissue. The HHA instructed on care of the dressing area, no specific documentation what the care was to the dressing areas, location, measurements, who received the education or the ordered procedure. P1's nursing visit note dated 4/30/24 indicated instruction given to patient/caregiver on wound care. The documentation did not include any details or comments. Goals met indicated patient verbalized tolerance to wound care. Patient/caregiver verbalizes/returns demonstration of wound care. There were no specific details on the wound care on what the caregiver verbalized or what demonstration was performed. P1's nursing visit note dated 5/2/24 indicated patient/caregiver were instructed how to prevent skin breakdown, to turn and reposition every two hours and to keep skin clean and dry. Verbalized understanding. The note failed to provide any education on the current wounds. indicated instruction given to patient/caregiver on wound care. The documentation did not include any details or comments. Goals met indicated patient verbalized tolerance to wound care. Patient/caregiver verbalizes/returns demonstration of wound care. There were no specific details on the wound care on what the caregiver verbalized or what demonstration was performed. P1's nursing visit on 5/14/24 indicated instruction given to patient/caregiver on wound care. The documentation did not include any details or comments. Goals met indicated patient verbalized tolerance to wound care. Patient/caregiver verbalizes/returns demonstration of wound care. There were no specific details on the wound care on what the caregiver verbalized or what demonstration was performed. P1's nursing visit on 5/28/24 indicated instruction given to patient/caregiver on wound care. The documentation did not include any details or comments. Goals met indicated patient verbalized tolerance to wound care. Patient/caregiver verbalizes/returns demonstration of wound care. There were no specific details on the wound care on what the caregiver verbalized or what demonstration was performed. P1's nursing visit on 6/4/24 indicated instruction given to patient/caregiver on wound care. The documentation did not include any details or comments. Goals met indicated patient verbalized tolerance to wound care. Patient/caregiver verbalizes/returns demonstration of wound care. There were no specific details on the wound care on what the caregiver verbalized or what demonstration was performed. P1's nursing visit on 6/11/24 indicated instruction given to patient/caregiver on wound care. The documentation did not include any details or comments. Goals met indicated patient verbalized tolerance to wound care. Patient/caregiver verbalizes/returns demonstration of wound care. There were no specific details on the wound care on what the caregiver verbalized or what demonstration was performed. P1's nursing visit note dated 6/18/24 care was providing dressing change to the right hip wound upon the nurse’s arrival the nurse was able to get measurements. Discussion with caregiver on a referral to a wound clinic for wound recommendations, the caregiver not interested at that time. No risk and benefits or details about any significant changes to the wound were documented. Upon interview on 7/26/24 at 10:37 a.m. P1's caregiver, family member (FM)-A stated the HHA did not provide education to her. She stated P1's Mother received education when P1 was in the hospital and P1's Mother taught FM-A how to change the dressing. Upon interview on 7/26/24 at 11:39 a.m. registered nurse (RN)-C stated she provided education to the family on signs and symptoms of infection and stated she offered the caregiver a wound care referral when one of the P/U's had deteriorated on 7/18/24. RN-C state there was never a return demonstration because the family always provided the dressing change care prior to the nursing visits and would not allow RN-C to remove the dressing. RN-C denied any HHA handout provided to the family about dressing changes, infection control while providing dressing care or signs of symptoms of infection. RN-C stated she was told by the caregiver that the hospital provided the dressing change procedure to her. P2’s POC for certification period 6/23/24 to 8/21/24 indicated P2’s pertinent diagnoses were chronic kidney disease, a cystoscopy, cerebral palsy, and pressure ulcers of the sacral area. P2’s DME supplies identified were dressing-foam, dressing-honey, dressing-paste, gauze packing strips, skin cleanser prep and wound cleanser. Upon observation on 8/1/24 at 11:00 a.m. P2 had a shower chair, a commode, a gait belt, and an electric wheelchair in his home. Upon interview on 8/1/24 at 11:30 a.m. RN-F stated P2 had the shower chair, commode, gait belt and electric wheelchair since he had been seeing in for approximately two months. He stated he was not certain what DME was on P2’s plan of care. P3’s POC for certification period 6/4/24 to 8/2/24 indicated P3’s pertinent diagnoses were congestive heart failure, Type II Diabetes, chronic kidney disease and oxygen dependence. P3’s DME supplies identified were dressing-antimicrobial, dressing-compression, dressing-foam, and dressing-honey. Upon observation on 8/1/24 at 12:30 p.m. P3 had a walker, a medical reach grabber an oxygen concentrator and tubing a glucometer and blood glucose test strips. Upon interview on 8/1/24 at 1:00 p.m. P3 stated she had had her walker and her grabber for over a year. She had been on oxygen since 2022 and has had diabetic supplies for about a decade. P4’s POC for certification period 7/24/24 – 9/21/24 indicated P4’s pertinent diagnoses were Type II diabetes, coronary artery disease and Parkinson’s disease. P4’s DME supplies identified were dressing-oil emulsion, gauze, gauze-roll, skin protectant, tape, and wound cleanser. Upon observation on 8/1/24 at 3:30 p.m. P4 had a shower chair, shower grab bars, a cane, a wheelchair a toilet raiser, a glucometer, and blood glucose test strips. Upon interview on 8/1/24 at 3:45 p.m. nursing assistant (NA)-A stated P4 had shower chair, grab bars, can and toilet raiser the entire time she had worked with him which had been about a month. Upon interview on 8/1/24 at 3:51 p.m. P4 stated he had been testing his blood sugars for about five years. P8’s POC for certification period 7/9/24 to 9/6/24 indicated P8’s pertinent diagnoses were Alzheimer’s disease, obstructive sleep apnea, chronic kidney disease, Type II diabetes, coronary artery disease and hemiplegia following cerebral infarction. P2’s DME supplies identified were rails/grab bars, shower/tub equipment and a rolling walker. Upon observation on 8/2/24 at 10:45 a.m. P8 had a mechanical hospital bed, a C-PAP machine, a lift chair, and a walker. Upon interview on 8/2/24 at 11:15 a.m. physical therapist (PT)-A stated that P8 has had the same bed, lift chair, walker and CPAP machine since the agency started seeing him in the home. P9’s POC for certification period 6/22/24 to 8/20/24 indicated P9’s diagnoses were anxiety, stage IV kidney disease, basal cell carcinoma and obstructive sleep apnea. The DME section of the POC lacked content. Upon observation on 8/2/24 at 1:00 p.m. P9 had a CPAP machine, a bedrail, a walker, and a lift chair. Upon interview on 8/2/24 at 2:10 p.m. RN-G stated she was aware of that P9 had the CPAP machine, the bedrail, walker, and lift chair and was not on his POC. P12’s POC for certification period 6/24/24 to 8/22/24 indicated P12 had a diagnosis of spinal muscular atrophy but failed to list her other diagnoses. The DME and supplies section of P12’s POC lacked content. P12’s POC for certification period 4/25/24 to 6/23/24 included the following DME: wheelchair cushion, bipap (non-invasive ventilation breathing support), bedside commode, wheelchair, oxygen saturation monitor, trach supplies, hospital bed, g-tube (gastrostomy tube) supplies, vent, tub/shower bench. P12’s registered nurse (RN) outcome and assessment information set (OASIS), dated 1/29/19, indicated P12 had diagnoses of neuromuscular scoliosis, tachycardia, tracheostomy status, and gastrostomy status. On 8/7/24, at 2:51 p.m., RN-A stated the POC should include the additional diagnoses, as listed on prior documents. RN-A stated the POC should also indicate the DME P12 requires for her care. RN-A stated it may be a software issue that the diagnoses and DME did not auto-populate. RN-A stated P12 continued to require the same DME as she did in her prior certification period. P13’s POC for certification period 7/19/24 to 9/16/24 DME and supplies section of P13’s POC lacks content, while the activities permitted section indicated cane and walker. P13’s RN OASIS admission assessment, dated 7/19/24, indicated P13 had a cane and multi-wheeled walker available and was assessed for safety and provided education on those items. P14’s POC for certification period 6/28/24 to 8/26/24 durable medical equipment (DME) and supplies section of P14’s POC lacks content, while the activities permitted section indicated wheelchair and walker. A physical therapy (PT) OASIS admission assessment, dated 6/28/24, indicated P14 had the following DME available and had been assessed for safety and provided education: elevated toilet seat, grab bars, rolling walker, and toilet rails. The PT assessment indicated P14 had a tub chair and wheelchair available but required further assessment. A RN OASIS admission assessment, dated 6/28/24, indicated P14 had the following DME available and had been assessed for safety and provided education: bed side commode, elevated toilet seat, grab bars, standard walker, tub chair, and wheelchair. P15’s POC for certification period 6/12/24 to 8/10/24 durable medical equipment (DME) and supplies section of P15’s POC lacks content. The POC lacks listing oxygen as a treatment for P15. P15’s RN OASIS admission assessment, dated 6/12/24, indicated P15 had continuous oxygen at 2 liters, upon admission. P15’s OASIS assessment indicated P15 had been assessed for safety and provided education on the following equipment: grab bars, oxygen, rolling walker, standard walker, tub chair, and wheelchair. P16’s POC for certification period, dated 6/12/24 to 8/10/24 durable medical equipment (DME) and supplies section of P16’s POC lacks content, while the activities permitted section indicated up as tolerated with walker. P16’s PT OASIS admission assessment, dated 6/12/24, indicated P16 had been assessed for safety and provided education for the following equipment: grab bars, multi-wheeled walker, oxygen, tub chair. Other DME available listed available as lift chair. P17’s POC for certification period, dated 6/13/24 to 8/11/24 durable medical equipment (DME) and supplies section of P17’s POC lacks content, while the activities permitted section indicated walker, the skilled nurse is to perform wound care to bilateral lower legs twice weekly. P17’s RN OASIS admission assessment, dated, 6/13/24, indicated P17 had been assessed for safety and provided education for oxygen and rolling walker. P17’s OASIS assessment indicated bilateral lower legs were to be cleansed with wound wash, apply xerofoam (a special type of dressing), apply skin prep to surrounding skin, cover with foam dressing twice weekly and as needed. The wound dressing supplies were not listed on the POC. Upon interview on 8/7/24 at 9:02 a.m. RN-H, an area manager stated all equipment should be documented on the POC. She stated items such as shower chairs, other bathroom equipment, commodes, oxygen and supplies, medication cadi’s, diabetic and wound supplies. An agency policy titled Initial Assessment/Certification with a revision date of 12/29/23 indicated the assessment will include the equipment presently in the home and potentially needed by the client. In addition, the policy indicated client/family/care giver education needs, ability, and readiness to learn are assessed.

On 4/2/24 through 4/5/24 an abbreviated complaint survey was conducted. This resulted in a partial extended survey at Adara Home Health. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. No deficiency was issued for the complaint investigations; however deficiencies were identified related to incidental findings at G576, G580, and G682. H80562541C (MN105756) H80562598C (MN102983) H80562599C (MN98609) H80562740C (MN96134) H80562741C (MN96060) H80562742C (MN70780)

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review the agency failed to maintain a current plan of care for 1 of 3 (P8) residents reviewed for quality of care. Findings Include: P8’s Plan of Care (POC) dated 2/20/24, for certification period 2/23/24 through 4/22/24 indicated P8 had diagnoses of Diabetes Mellitus Type 2. Discipline orders directed skilled nursing once weekly for seven weeks. The POC directed skilled nurse to review medication profile and reconcile medications as needed, perform medication assessment, and fill medi-planner per current medication orders/profile every week. P8’s POC directed Centrum Women 18 milligram (mg)-400 microgram (mcg), 1 tablet twice daily. P8’s POC directed Metformin 1000mg daily. During an observation on 4/3/24 at 3:00 p.m., registered nurse (RN)-B completed a medication set up for P8 for a full medi-planner plus two full days in another medi-planner. During the medication set up, P8 clarified her Metformin dose was increased from 1000mg to 1500mg in November 2023. RN-B verified Metformin prescription bottle directed to take 1500mg daily. The prescription bottle was observed to have been filled on 11/6/23. RN-B verified previously filled days in the medi-planner had 3 tablets, totaling 1500mg each. P8 also clarified to RN-B that Centrum Women tablets were replaced with Centrum Womens Gummies last week. RN-B verified previously filled days in the medi-planners had 2 gummies set up for each day. RN-B completed the set up with 2 Centrum Womens Gummies. On 4/3/24 at 4:15 p.m., RN-B stated she did not have orders to set up Metformin 1500mg or Centrum Womens Gummies. RN-B stated the POC should be kept up-to-date with current orders. On 4/4/24 at 11:33 a.m., area clinical manager (CM)-A stated orders are to be immediately entered into the patients’ chart upon receipt. CM-A stated the POC should be revised as orders are changed. CM-A stated the agency did not have orders directing Metformin 1500mg daily. A facility document Medication Management policy, dated 6/8/22 directed: if a new and/or changed medication is prescribed during the certification period, a verbal order will be obtained from the physician to confirm the additional/changed medication (s)., the medication profile will be updated accordingly and changes to the POC/medication profile will be communicated to the client/caregiver and confirm consent and understanding of the change(s). A facility document Clinical Practice Foundations policy dated 6/2/21, directed physician’s and non-physician practitioner’s (NPP) orders will be obtained in compliance with all federal requirements and state professional practice acts.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review the agency failed to follow orders for medication set up for 1 of 1 (P8) patients reviewed for medication management. Findings Include: P8’s Plan of Care (POC) dated 2/20/24, for certification period 2/23/24 through 4/22/24 indicated P8 had diagnoses of Diabetes Mellitus Type 2. Discipline orders directed skilled nursing once weekly for seven weeks. The POC directed skilled nurse to review medication profile and reconcile medications as needed, perform medication assessment, and fill medi-planner (a system for holding and organizing pills 4 times a day for 7 days) per current medication orders/profile every week. P8’s POC directed Centrum Women 18 milligram (mg)-400 microgram (mcg), 1 tablet twice daily. P8’s POC directed Metformin 1000mg daily. During an observation on 4/3/24 at 3:00 p.m., registered nurse (RN)-B completed a medication set up for P8 for a full medi-planner plus two full days in another medi-planner. During the medication set up, P8 clarified her Metformin dose was increased from 1000mg to 1500mg in November 2023. RN-B verified Metformin prescription bottle directed to take 1500mg daily. The prescription bottle was observed to have been filled on 11/6/23. RN-B verified previously filled days in the medi-planner had 3 tablets, totaling 1500mg each. P8 also clarified to RN-B that Centrum Women tablets were replaced with Centrum Womens Gummies last week. RN-B verified previously filled days in the medi-planners had 2 gummies set up for each day. RN-B completed the set up with 2 Centrum Womens Gummies. On 4/3/24 at 4:15 p.m., RN-B stated she did not have orders to set up Metformin 1500mg or Centrum Womens Gummies. RN-B stated she set the increased dosage of Metformin up per the directions on the prescription bottle dated 11/6/23. RN-B stated she set up the Centrum Womens Gummies as they were close to the Centrum Womens multi-vitamin tablets and the tablets were not available. On 4/4/24 at 11:33 a.m., area clinical manager (CM)-A stated she would have expected RN-B to have called P8’s doctor to clarify the medications and dosages prior to setting up the medication in medi-planner and leaving P8’s home. CM-A stated orders are to be immediately entered into the patients’ chart upon receipt. CM-A stated the POC should be revised as orders are changed. CM-A stated medication profiles should be reconciled at every visit and at the time of recertification. CM-A stated the agency did not have orders directing Metformin 1500mg daily. A facility document Medication Management policy, dated 6/8/22 directed to contact the physician/ nurse practitioner, if necessary to correct medication issues such as significant medication issues, discrepancies between the medications orders, the medications in the home and/or the client’s understanding of the medication. The policy also directed if a new and/or changed medication is prescribed during the certification period, a verbal order will be obtained from the physician to confirm the additional/changed medication (s)., the medication profile will be updated accordingly and changes to the POC/medication profile will be communicated to the client/caregiver and confirm consent and understanding of the change(s). A facility document Physician/Non-Physician Practitioner Orders policy dated 7/20/21, directed there must be a current written or electronically recorded order or prescription for all client treatments and therapies, including all prescribed medications that the company is managing for the client. A facility document Clinical Practice Foundations policy dated 6/2/21, directed physician’s and non-physician practitioner’s (NPP) orders will be obtained in compliance with all federal requirements and state professional practice acts. 6. Administer medications and perform treatments in accordance with physician/NPP order, state nurse practice acts, and professional standards of care. No medication/solution is to be administered without physician/NPP verification regarding the medication/solution name, dose, route, time, duration of administration and expiration date. Verify the medication label is clear, concise and correct before administration.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation and interview the agency failed to follow infection control practices for 2 of 3 patients (P6 and P7) observed home health visits to prevent the transmission of infections and communicable diseases. Findings Include: P6’s Plan of Care (POC), dated 3/16/24 for certification period 3/16/24 through 5/14/24, indicated P6 had diagnoses of dehiscence of amputation stump (an opening of a surgical wound at the site of leg amputation) and infection of right lower extremity amputation stump. Discipline orders for P6 directed skilled nursing one time per week for seven weeks. The POC directed the skilled nurse to perform and teach wound care to the patient. The POC also directed the skilled nurse to observe and assess skin integrity status, cardiovascular status, respiratory status, and report vital signs outside of established parameters. P6’s POC directed safety measures of universal precautions (precautions used with every patient to treat all human body fluids as if they were known to be infectious). On 4/3/24 at 11:35 a.m., licensed practical nurse (LPN)-A placed her bag on a reusable barrier on the floor. LPN-A removed the following equipment to complete vital signs during her assessment for P6: blood pressure cuff, stethoscope, oximeter (device to determine oxygenation level) and thermometer. The blood pressure cuff was placed on P6’s arm, the stethoscope bell was placed on P6’s arm and the earpieces were placed in LPN-A’s ears. The oximeter was placed on P6’s finger. The thermometer was touched to P6’s forehead. LPN-A returned the equipment directly to her bag, without sanitizing it. LPN-A moved her bag off the barrier and set it directly on the floor, while she folded the barrier and placed it directly in her bag, without sanitizing the reusable barrier. On 4/3/24 at 11:55 a.m., LPN-A stated she should not have placed her bag directly on the floor and she should have cleaned the barrier prior to placing it into her bag. LPN-A stated she planned to wipe the blood pressure cuff, stethoscope, oximeter and thermometer with a disinfectant wipe once she got out to her car. LPN-A stated she thought the patient would think it was rude of her to clean the equipment while in her room. P7’s POC, dated 2/26/24 for certification period 2/27/24 through 4/26/24, indicated P7 had diagnoses of a stage 4 (full-thickness skin loss with exposed bone, tendon or muscle) pressure ulcer (injury to skin resulting from prolonged pressure) to the right buttock, a stage 4 pressure ulcer to the right hip, a stage 3 (full thickness tissue loss) pressure ulcer to the right ankle, and quadriplegia (paralysis that affects all limbs and body from the neck down). Discipline orders for P7 directed skilled nursing one time per week for one week, followed by two times per week for 8 weeks. The POC directed the skilled nurse to perform wound care for right buttocks, right hip stage 4 pressure ulcers and right ankle stage 3 pressure ulcer three times weekly. The POC directed the home care agency to complete wound care Mondays and Wednesdays, and the wound care clinic to complete wound care on Fridays. P7’s wound care clinic orders, dated 3/29/24, directed to cleanse the right buttocks wound with wound cleanser, pack collagen, cover with an antimicrobial dressing, and secure with a foam dressing with adhesive border. P7’s wound care clinic orders, dated 3/29/24, directed to cleanse the right ankle wound and right hip wound with wound cleanser, wipe peri wound area with skin prep (provides a barrier between the patient’s skin and the adhesive on the dressing), pack collagen, cover with an antimicrobial dressing, and secure with a foam dressing with adhesive border. P7’s POC directed safety measures of universal precautions. On 4/3/24 at 1:45 p.m., while wearing gloves, registered nurse (RN)-A removed and discarded the soiled dressing from P7’s right ankle. RN-A did not remove her gloves. RN-A touched the wound cleanser bottle and cleansed the wound. RN-A placed the wound cleanser bottle back on the nightstand. RN-A wiped the perimeter of the wound with skin prep, applied the collagen, covered with the antimicrobial dressing, and secured with the adhesive foam dressing. RN-A placed the remaining supply of wound care products and scissors on the nightstand. RN-A then removed and discarded her gloves. RN-A did not disinfect the reusable equipment. RN-A did not perform hand hygiene between glove use. RN-A applied a new pair of gloves. RN-A removed and discarded the soiled dressings from the right buttocks and right hip. RN-A did not remove her gloves. RN-A took the wound cleanser from the nightstand and cleansed both the right buttocks wound and the right hip wounds with separate pieces of gauze. RN-A then discarded her gloves and performed hand hygiene. RN-A applied a new pair of gloves. RN-A applied the skin prep to the buttocks wound, placed the collagen in the center, covered with the antimicrobial dressing, secured with adhesive foam dressing. RN-A did not perform hand hygiene or change gloves before beginning care for the next wound. RN-A placed collagen in the center of the wound, covered with the antimicrobial dressing, and secured the dressing with an adhesive foam dressing. RN-A straightened P7’s clothing, sheets and sling and then removed her gloves. RN-A did not perform hand hygiene. RN-A picked up the wound cleanser bottle, scissors, and other wound care supplies and placed them into a drawer. The reusable items were not sanitized prior to placing into the drawer with other clean wound care and ostomy supplies. On 4/3/24, RN-A stated she should have changed her gloves and performed hand hygiene after removing the soiled dressings and between each wound. RN-A stated she should have cleaned the reusable equipment prior to placing it in the drawer with clean supplies and equipment. On 4/5/24 at 10:37 a.m., area clinical manager (CM)-A stated reusable items should be cleaned before they are returned to the nurse’s bag. CM-A stated gloves should be changed when soiled, after wound care, between removing the soiled dressing and putting on the clean dressing, between wounds and between procedures. On 4/5/24 at 11:12 a.m., CM-B stated hand hygiene should be performed, and gloves should be changed between wounds or performing a new procedure. On 4/5/24 at 12:23 p.m., the Vice President of Clinical Services stated equipment should be cleaned after each use and before it is returned to the nurse’s bag. She stated gloves should be changed anytime the nurse is going from dirty to clean areas. She stated hand hygiene should be performed between glove changes. A facility document, Infection Prevention-Supply Bag Guidelines, dated 11/1/23, directed the purpose of the supply bag is the protect the client, family members and health care personnel from the spread of microorganisms by utilizing appropriate bag technique. The inside of the supply bag and its contents are considered clean, therefore: Instruments/equipment which have been used in the care of a client should be cleaned before being returned to the bag. Never return unclean equipment to the supply bag. The policy directed never place the bag on the floor or furniture. A facility document Clinical Practice Foundations policy, dated 6/2/21, directed Handwashing shall be performed by the direct caregiver in the following situations: D. Before and after non-invasive procedures, such as dressing changes E. After the removal of sterile and non-sterile gloves F. Before entering the clean section of the supply bag A facility document Wound Assessment, dated 2/19/24, directed: Discard soiled dressing in the trash. Remove and discard soiled gloves. Perform hand hygiene. Put on new gloves.

On 4/11/23 – 4/13/23, a complaint survey was conducted. This resulted in a partially extended survey at Adara Home Health. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. H80561264C/94355 was unsubstantiated with no deficiencies issued. H80561266C/95974 was substantiated with deficiency issued at G478. H80561265C/95003 and H80569977C/97183 were substantiated with deficiency cited at G536. The Condition of Participation 42 CFR 484.50 Patient Rights at G430 and 42 CFR 484.55 Comprehensive Assessment of Patients at G536 was found not met.

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 interviews and document review, the facility failed to thoroughly investigate a medication error for 1 of 1 client (P3) who reported her iron medication was set up daily instead of every other day as ordered. P3’s Home Health Certification and Plan of Care (POC) dated 1/17/23 to 3/17/23, indicated diagnoses of anemia, gastric ulcer, unspecified as acute or chronic without hemorrhage or perforation, irritable bowel syndrome without diarrhea and gastroesophageal reflux disease. P1’s frequency of visits was skilled nursing visits (SNV) once every other week to review medication profile and reconcile medications as needed and may fill medi-planner per current medication orders/profile. P3’s POC indicated she received Ferrous Gluconate (iron) 324 milligrams (mg) tablet every other day, A complaint made to the facility for P3 on 2/08/23, from P3’s Care Coordinator (CC) indicated there were some concerns her registered nurse (RN) was consistently mixing her medication and have not ordered medications on time causing [P3] not to receive certain medications for weeks. In addition, the complaint indicated the patient stated she had current eye surgery and was no longer able to check the medications that were set up by the RN. The CC further requested to increase her SNV visits to weekly. The facility investigation indicated they spoke to licensed practical nurse (LPN)-G, who stated P3 told her that iron was set up daily and it was supposed to be every other day. LPN-G stated the client had received 90 days (45 tablets) about a month and a half ago and that it was gone. In addition, LPN-G stated P3, informed her the PCA had pulled the iron out, but some were taken, could not estimate how many. The investigation then indicated an interview with LPN-H who allegedly performed the preparation error and she had specifically remembered setting up the medications every other day which was documented in the medication setup note. LPN-H also indicated she also practices having her clients look at the medication set up prior to departure and recalls [P3] stating they looked good. The report indicated they did receive orders to increase her visits to weekly. During interview on 4/12/23, at 4:50 p.m. with the area director (AD) at the Blaine branch office stated LPN-G went out to P3’s home after the complaint was made and since the PCA took the medications out there was no way to know if there was an error or not, it was just an allegation and there was no way to prove it. In addition, since she had the correct number of pills left, they felt it really could not have been an error. The AD did state they never did contact the pharmacy to verify the medication amount, nor did they call the PCA to see if she could verify seeing the iron in the medication set up as daily. A facility policy titled Client Incident, Accident, Injury, or Unusual Occurrence dated 4/17/18 indicated the supervisor should review the Unusual Occurrence Report and determine the factors which contributed to the occurrence and complete the required documentation. The completed Unusual Occurrence Report should be submitted to the Branch General Manager for review and investigation if necessary.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on the number and/or severity of the deficiency cited the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients at G536 was found not met. The agency failed to ensure accurate medication set-up for 2 of 2 patients (P1 and P2) reviewed when an antipsychotic medication, Abilify, for P1 was not ordered and set up as prescribed. P1 went without Abilify for approximately 28 days and was hospitalized and nursing staff entered an order for Montelukast (prevent symptoms of asthma) 10 mg daily without receiving a verbal physician order. P2’s medication for neuropathy and iron were not set-up as prescribed resulting in addition dosing and skilled nursing visits for patient monitoring. Refer to G536 - Based on interview and document review the agency failed to ensure accurate medication set-up for 2 of 2 patients (P1 and P2) reviewed when an antipsychotic medication, Abilify, for P1 was not ordered and set up as prescribed. P1 went without Abilify for approximately 28 days and was hospitalized and nursing staff entered an order for Montelukast (prevent symptoms of asthma) 10 mg daily without receiving a verbal physician order. P2’s medication for neuropathy and iron were not set-up as prescribed resulting in addition dosing and skilled nursing visits for patient monitoring.

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 interview and document review the agency failed to ensure accurate medication set-up for 2 of 2 patients (P1 and P2) reviewed when an antipsychotic medication, Abilify, for P1 was not ordered and set up as prescribed. P1 went without Abilify for approximately 28 days and was hospitalized and nursing staff entered an order for Montelukast (prevent symptoms of asthma) 10 mg daily without receiving a verbal physician order. P2’s medication for neuropathy and iron were not set-up as prescribed resulting in addition dosing and skilled nursing visits for patient monitoring. P1's Home Health Updated Plan of Care Report (POC), dated for the certification period 3/13/23 through 5/11/23, indicated P1 had bipolar and anxiety disorders. The POC further indicated P1 received skilled nursing visits (SNV) one time a week times five weeks to observe and assess P1 with generalized depression and to assess the need for medication changes and the potential for the need for referral to provide counseling and assistance with managing depression. The POC further indicated P1 would receive a skilled assessment to evaluate the patient for maladaptive, aggressive, noncompliant, self-harming, and/or abusive behaviors. Assess medication/treatment compliance, the need for medication changes, and the potential need for referral to a provider for counseling/assistance with managing behaviors. Provide skilled teaching to promote personal safety, reduce maladaptive behaviors, improve daily health practices, and report significant concerns in behaviors to physician and nurse practitioner (NP) for interventions dated updated 4/04/23. P1's POC further indicated she received Abilify 20 milligrams (mg) for major depression daily. A Facility Reported Incident dated 3/31/23, indicated on 3/31/23, at 12:00 p.m. the home care agency received a phone call from the hospital pharmacy stating [P1] was admitted to the hospital for symptoms of hypomania, the pharmacy also advised they were worried [P1] was not receiving the correct medications set up in the home by the agency. After coordinating with the primary care provider, in reconciling medications not set up for the client of Abilify (an antipsychotic medication) from 2/06/23 to 3/10/23 and 3/24/23 through 3/31/23. The facility Investigation addendum from 3/31/23 indicated there was an additional medication error that occurred with P1. Licensed Practical Nurse (LPN)-C stated she entered an order for Montelukast (prevent symptoms of asthma) 10 mg daily on 3/22/23, without receiving a verbal order. LPN-C stated she entered the order because P1 stated she should be taking it. During interview on 4/13/23, at 10:37 a.m. P1's registered case manager (RNCM)-A stated he took over P1's case on 4/01/23, although RNCM-A had known her previously through the agency. RNCM-A stated he received a phone call on 3/31/23, from P1's hospital pharmacist questioning what medications P1 was receiving and wanted to go over her medication list. RNCM-A stated he then notice P1 had missed her Abilify medication due RN-D had accidentally discontinued it from the medication list during the resumption of care visit on 2/7/23. The provider signed the resumption of care order on 2/13/23 that did not include the Abilify listed as part of the medication regimen, therefore it was not reflected within the medication profile following the 2/7/23 visit. In addition, RNCM-A stated RNCM-B copied and pasted the previous medication list which had the Abilify listed and did set up the [P1]'s Abilify through 2/21/23. LPN-C performed a visit on 2/21/23 and followed the medication profile to set up the medications which did not have Abilify listed, therefore did not fill the Abilify medication from 2/21/23 to 3/10/23. On 3/10/23, RNCM-B set up the Abilify medication from 3/10/23 through 3/24/23 after copying and pasting a previous medication list which reflected the medication prior to the resumption of care visit. On 3/22/23, LPN-C did not set up Abilify from 3/22/23 through 3/31/23, due to the medication profile not listing the medication as it was discontinued following the resumption of care visit. During interview on 4/13/23, at 11:00 a.m. P1's physician assistant (PA), and registered nurse (RN)-G stated P1 received a call from RNCM-A informing the PA, P1 was becoming more manic and had a fall on 4/11/23 and had lost her leg strength and had two other falls. RN-G stated she was never informed P1 missed receiving her Abilify medication and that would have been important to know, especially since P1 went to the emergency department again this week. In addition, RN-G stated she spoke with the (PA) who stated P1's hospitalization on 3/31/23, was due to missing her Abilify medication. P1's Hospital Discharge Summary dated 4/03/23 indicated P1's discharge diagnoses were mixed bipolar disorder related to malingering (falsification or profound exaggeration of illness), the discharge summary further indicated P1 had symptoms of thrashing her apartment, paranoia, anxiety, and impulsivity upon admission. The discharge summary further indicated that P1 is to continue her Abilify 20 mg in the evening. During interview on 4/13/23, at 11:30 a.m. director of quality improvement (DOQI) stated RN-D and LPN-C had received coaching on their medication error and both are assigned to complete medication procedure in Lippincott by 4/15/23 and attend medication training on 4/20/23. P2's POC dated 12/24/22 through 02/21/23, indicated P2 had idiopathic chronic gout, superficial frostbite, cellulitis of the left lower limb, and acute embolism of the right femoral vein. In addition, the POC indicated P2 received skilled nursing one time a week to review the medication profile and reconcile medications as needed. P2's POC further indicated P2 received Gabapentin (for neuropathy) 100 mg capsules, 200 mg at 8:00 a.m. and 100 mg at 5:00 p.m. and Ferosul (iron) 325 mg take one tablet daily. A Facility Reported Incident dated 12/28/22, at 12:37 p.m. indicated licensed practical nurse (LPN)-A completed a skilled nursing visit on 12/28/22, and noticed medications set up by registered nurse (RN)-F, had errors which included two iron pills that should have been only one pill, in addition, the P2 had orders for gabapentin 100 mg three times daily (for a total dose of 300 mg daily), and the medication set up was 300 mg in the morning, and 300 mg the evening in addition to some evenings it also had 400 mg set up in P2's pill box. The agency investigation undated, indicated they informed P2’s physician of the medication error and received an order for P2 to be seen for SNV daily for seven days for close assessment of the client’s condition and monitoring for any signs or symptoms of side effects or adverse reactions and no further action was needed but an ongoing assessment of the client’s status and reporting any side effects and adverse reactions to the physician immediately. In addition, the investigation indicated P2’s Gabapentin order was changed to 200 mg in the morning and 100 mg in the evening since the dose flip machine only allowed for P2’s medication to be set up twice daily. During interview on 4/11/23, at 10:45 a.m. the director of quality improvement (DQI) stated registered nurse (RN)-F made the medication errors with P2’s medication set up and while they were completing their investigation, they were unable to contact RN-F because she was on vacation. DQI then stated when they tried to have her come in and talk with her, she resigned and dropped her supplies of at another employee’s house, so they never were able to interview her. Medication Error Policy revised 5/10/21, indicated a medication error is any error significant or not significant, that includes all errors in wrong medication, wrong time, wrong dose, extra dose, wrong route of administration, omission of ordered dose, or length of infusion whether caused by an employee or the client. The policy also identified a significant medication error as any error that requires or results in any of the following: discontinuing a medication or modifying a dose, hospitalization, disability, treatment with a prescribed medication, cognitive deterioration or impairment, life-threatening situation, death, or congenital anomalies. Once a medication error is noted, the employee is to notify the Case Manager and complete an Unusual Occurrence Report. The Branch General Manager or Clinical Manager is informed of the occurrence by the Case Manager and notify the physician and intervene as needed.

On 3/22/23 - 3/23/23 a complaint survey was conducted. This resulted in a partial extended survey at Adara Home Health. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. The following complaint was investigated with no citations issued: H80569456C/96841 and 96810.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on the number and/or severity of the deficiency cited the Condition of Participation 42 CFR 484.50 Patient Rights at G430 was not met. The agency neglected to conduct psychiatric assessments/evaluations or monitor medical needs as identified in the plan of care for a patient on an antipsychotic and antidepressant medication for 1 of 1 patient (P1) reviewed for necessary care and services. P1 went without Clozaril and Cymbalta medications for approximately 45 days and required hospitalization.

Property and person treated with respect CFR(s): 484.50(c)(1) Have his or her property and person treated with respect; This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to respect the preference of patients when assigning visit schedules for 3 of 3 patients (P1, P2, and P3) reviewed. P2 attempted to cancel due to post-traumatic stress disorder (PTSD), and P1 and P3 did not participate in their agency visit schedule. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23 to 3/21/23, indicated P1 diagnoses were schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. Upon interview on 3/22/23, at 10:43 a.m. P1 stated her next skilled nursing visit was on 3/23/23, however she does not know the time of the visit. P1 stated the times are never consistent the agency calls me the day before and lets me know the time. “It’s frustrating not knowing the time, as I can’t plan anything else that day.” P1 denied having a calendar in her home of the agency’s visits. P2’s (POC) dated 2/9/23, indicated P2’s diagnoses were chronic pain syndrome, polyneuropathy (numbness and weakness of multiple nerves), generalized anxiety disorder, post-traumatic stress disorder and occlusion and stenosis of the left carotid artery. P2’s frequency of visits was for weekly skilled nursing. P2’s Patient Information Record dated 2/27/23, indicated reason visit was not made was patient cancelled at the door. Her needs were met by having a backup of medication set-up. The note did not indicate if P2 was aware of the change of visit from a Thursday to a Monday. P2’s Patient Information Record Dated 3/2/23, indicated the reason the visit was not made was because P2 did not answer her door and did not return phone calls. The note did not indicate how P2’s needs were met. P2’s Patient Information Record dated 3/6/23, indicated a call to the P2 regarding the two missed visits asking P2 if she still wishes to have services from the agency due to two missed visits. The note did not indicate P2’s response. P2’s Patient Information Record dated 3/9/23, indicated LPN-A contacted P2 on 3/8/23, to set-up a time for the 3/9/23, visit. P2 acknowledged a time. On 3/9/23, LPN-A received a text message from P2 indicating P2 did not want a visit as she was uncomfortable with LPN-A being in her apartment. LPN-A was going to chart visit as a missed due to client refusal. LPN-A received a text message from the home office requesting that writer go to P2’s apartment as she was willing to have a visit. Upon arrival LPN-A found P2 to be very agitated and upset saying she does not know why he was there. P2 refused vital signs and assessment. P2 told LPN-A she was going outside and left LPN-A alone in her apartment. LPN-A noticed thirteen of P2’s medication bottles were completely empty and P2 had only four other medications on hand. LPN-A filled the medications on hand and ordered the rest of the medication. The medications would not be ready at the pharmacy until 3/14/12. P2 became upset-up again and told LPN-A she would get the medications the following day. LPN-A advised P2 when she did receive all the medications to call the agency. P2’s Patient Information Record dated 3/13/23, RN-A notified primary care physician about P2’s visit from 3/9/23, increased anxiety and missing medications from the home. The note did not indicate that the agency sent in a male client when client has a history of trauma from a man. P2’s Patient Information Record dated 3/15/23, indicated P2’s county case manager, called RN-A requesting only a female nurse to do the visits due to P2’s past traumatic experience. Upon interview on 3/22/23, at 1:44 p.m. P2 stated she has weekly nursing visits. P2 stated “Well it’s late afternoon and they haven’t called me, no one will probably show-up tomorrow.” P2 stated she is aware of the day of the week a nurse is coming, but not the time the nurse is arriving, or who the staff is. P2 stated she has left her home because she has not heard from the agency and that has resulted in missed visits. P2 stated the agency called her and asked if she still wanted services because she had missed two visits. P2 stated she was not aware that the agency was switching her 2/27/23, which was a Monday and then the agency attempted to see her on 3/4/23, without notifying P2 of the time for the visit. P2 stated on 3/8/23, she received a call from a “man” at the agency trying to set-up a visit time for 3/9/23. P2 stated she did set-up a time, but later sent licensed practical nurse (LPN)-A a text message saying she was uncomfortable with him coming to visit her. P2 stated she was violently assaulted years ago by a man and she feared being alone with the male staff. On 3/9/23, LPN-A showed-up to visit P2 and she became very anxious, fearful, and got “emotional” with LPN-A. “I was just scared, very scared, they know my history and I refused this visit.” P3’s POC dated 2/17/23, indicated P3’s diagnoses included type II diabetes, with chronic kidney disease, history of falls, unspecified mental disorder, and obesity. P3’s frequency of visits was one skilled nursing visit every other week. Upon interview on 3/22/23, at 2:45 p.m. P3 stated he is aware what day of the week, the agency is coming “for the most part”, however is never aware of the time of the visit. “A consistent time would be nice; I just don’t schedule anything on the day I know they are coming.” Upon interview on 3/22/23, at 3:18 p.m. RN-A, clinical supervisor stated that the agency does call the client's the day before the visit to set-up the time. RN-A also stated he was unaware if P2 missed visits due to leaving her home because she did not know the time of the visits. In addition, he stated after a male nurse was sent to P2's home, P2's county case worker called and reminded the agency of P2's violent past with a male and asked for a female staff member only. RN-A did not believe another male staff member had seen P2 since the complaint. Upon interview on 3/22/23, at 4:12 p.m. RN-C stated she does not know her work schedule until the day before. The agency lets the staff know the schedule and the agency or the nurse reach out to the patient the day before and sets the times. RN-C stated the reason the agency schedules like that is if the agency needs to staff a start of care or something else, then the agency can move the clients around. Upon interview on 3/22/23, at 4:40 p.m. RN-E, regional operations manager, stated the agency has the assigned nursing staff call the patient’s the day before the visit, this is because the staff schedules can change from day to day. For the home health aide staff RN-E believed a schedule is sent out to the patients. A facility policy titled Client Notification of Changes in Care/Service dated 6/9/23, indicated under the heading client visit schedule changes. 1. Company personnel will notify the staffing manager/designee where there is a need to significantly alter a client’s schedule (i.e., moving a visit from morning to afternoon). 2. When a significant variation of tentative time for visit (i.e., greater than one hour) is anticipated, the staffing manager/designee will immediately notify the client of the change and verify acceptance. 3. Notification to the client will be documented in the client’s clinical record. Documentation may include Date and time of the notification, specific schedule changes and the client’s response to the schedule change. A facility policy regarding specialized nursing services for PTSD patients was requested, however none was received.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on interview and document review the agency neglected to conduct psychiatric assessments/evaluations or monitor medical needs as identified in the plan of care for a patient on an antipsychotic and antidepressant medication for 1 of 1 patient (P1) reviewed for necessary care and services. P1 went without Clozaril and Cymbalta medications for approximately 45 days and required hospitalization. U.S. Food and Drug Administration (FDA) website https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s084lbl.pdf for Clozaril prescribing information indicated Clozaril is an atypical antipsychotic medication used for the treatment of resistant schizophrenia, reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Clozaril is indicated for treatment of patients who fail to respond adequately to standard antipsychotic treatment. Clozaril is a high-risk medication that can cause severe neutropenia, orthostatic hypotension, bradycardia, syncope, seizure, myocarditis, cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis. The following warnings and precautions include eosinophilia, QT interval prolongation, metabolic changes such as hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain, neuroleptic malignant syndrome, hepatotoxicity, fever, pulmonary embolism, anticholinergic toxicity, and interference with cognitive and motor performance. Clozaril has caused neutropenia leading to serious infection and death. Patients responding to Clozaril should continue maintenance treat of their effective dose beyond the acute episode. Abruptly discontinuing Clozaril is necessary only as a result of moderate to severe neutropenia, a gradually dose reduction should be planned over a period of 1 to 2 weeks. All patients should be carefully monitored for the recurrence of psychotic symptoms and symptoms related to cholinergic rebound such at profuse sweating, headache, nausea, vomiting, and diarrhea. Re-initiation of Clozaril treatment after a patient has discontinued Clozaril for 2 days or more since last dose is to reinitiate with 12.5 mg once or twice daily, if well tolerated the dose may be increased to the previously dose more quickly. Clozaril is only available through a restricted program under a Risk Evaluation and Mitigation Strategies (REMS) program because of the risk of severe neutropenia. Healthcare professionals who prescribe, patients who receive, and pharmacies dispense Clozaril must be enrolled and/or certified in the program. Patient and caregiver counseling information include the risks and warnings of taking Clozaril, reporting any symptoms to their provider, any potential drug to drug interactions of prescribed or over-the-counter medications. U.S. Food and Drug Administration (FDA) website https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf for Cymbalta prescribing information indicated Cymbalta is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. Dosage of Cymbalta was based on the indication for use. Warnings and precautions included Discontinuation Syndrome indicate patients should be monitored for symptoms when discontinuing treatment, a gradual reduction dose rather than abrupt cessation is recommended whenever possible. Additional warnings included hepatotoxicity, orthostatic hypotension, falls, syncope, serotonin syndrome, increased risk of bleeding, sever skin reactions, activation of mania or hypomania, angle-closure glaucoma, seizures, blood pressure increases, inhibitors of CYP1A2 or Thioridazine, hyponatremia, or condition that slow gastric emptying. The medication guide indicated topics on telling your healthcare provider right away of symptoms and feelings listed, what is Cymbalta, who should not take Cymbalta, how should you take it, and what you should avoid while taking Cymbalta, medical conditions to tell your provider, and side effects. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23 to 3/21/23, indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. P1’s orders of discipline and treatments. 1. Skilled nurse (SN) for instruction/reinforcement of diabetic care to include diet, skin care, administration of insulin, blood glucose testing and diabetic foot care. 2. SN to provide skilled teaching/reinforcement of management of hypertension. 3. SN to review medication profile and reconcile medications as needed, SN may instruct and reinforce medication teaching related to use of medications to treat disease process, SN may fill medication orders/profile bi-weekly. 4. Skilled nurse for observation/assessment of patient’s impaired nutrition related to obesity, instruction patient/caregiver on interventions designed to improve nutritional intake and patient well-being. 5. SN for administration of ability via IM injection every month. 6. SN to perform multifactor fall risk assessment and implement interventions to decrease risk of falls. SN to instruct on home safety, impact of polypharmacy, environmental safety and fall prevention. 7. SN to evaluate and develop plan of care to be countersigned by physician, SN to assess/evaluate co-morbid conditions including schizoaffective disorder and other conditions that present themselves while this episode to identify changes and intervene to minimize complications. 8. SN to observe and assess cardiovascular system to identify changes and intervene to minimize complications. SN to provide skilled teaching related to altered cardiovascular status including pathophysiology, nutrition, medication regimen, and permitted activities. May perform oxygen saturation levels as needed for signs and/or symptoms of possible respiratory complications. 9. SN to provide instructions related to management of congestive heart failure including, but not limited to definition, risk factors, measures to prevent exacerbation, signs/symptoms, and potential complications. 10. SN to monitor plan for current treatment of depression such as effects of medication and/or need for referral for other treatment. 10. All orders disciplines will assess for vulnerability/maltreatment concerns/changes, review the vulnerable/abuse prevention plan, facilitate patient advocacy, notify physician/nurse practitioner and/or refer to MAARC/county common entry point as appropriate for changes/concerns in vulnerability/maltreatment. 11. All ordered disciplines will implement the individual vulnerability/maltreatment/abuse prevention plan, self-management, personal safety, implement pathway, need for skilled care related to fall risk and or behavior and or need for other disciplines. 12. Self-management, medication set-up/management, implement pathways, medication management, assess for medication compliance and alert physician of significant issues/missed doses. Teach patient/caregiver how to set-up medications. Teach medication reminders including alarms. P1’s orders in the POC failed to identify any parameters for P1’s blood glucose levels, vital signs, weight monitoring, and comorbid conditions related to schizoaffective disorder. The POC failed to identify Clozaril and Cymbalta assessments, lab draws, missed doses, provider notification, and side effects. P1’s therapeutic level of Clozaril indicated the following lab values. A normal therapeutic range for the use of Clozaril was 350-600 ng/ml. lab level dated 1/3/23 indicated a level of 910 nanograms/milliliter (ng/ml) lab level dated 1/31/23 indicated a level of 952 ng/ml lab level dated 3/7/23, was lab level dated 3/16/23 was 101 ng/ml P1’s patient information report dated 1/26/23 did not identify any psychiatric assessments, medical monitoring, medication side effects, medication compliance or treatment goals. P1 was instructed to call family or the crisis hotline if she had thoughts of harming herself. P1’s medications were set-up from 1/26/23 through 2/8/23 including Clozaril and Cymbalta. P1’s patient information report dated 2/9/23 indicated there was no psychiatric assessment or medical monitoring, medication side effects, medication compliance or treatment goals during the visit. P1’s medications were set-up from 2/9/23 through 2/23/23, including Clozaril and Cymbalta. P1's patient information report dated 2/12/23 indicated P1 was hearing voices, RN-C re-educated her on the importance of calling the suicide hotline. P1 stated she had a "psych" appointment, uncertain if the appointment was with her psychologist or psychiatrist. RN-C did not conduct a psychiatric assessment nor were additional interventions identified. There was no note of medical monitoring, medication side effects, medication compliance or treatment goals. The note indicated all mediations were set-up, there was not a list and dates of the medications set-up. P1’s patient information report dated 2/27/23 P1 was seen on 2/25/23 with a note indicating no changes to the medication regimen, the note did not identify any psychiatric assessments, medical monitoring, medication side effects, medication compliance or treatment goals. The note failed to provide a list of the medications set-up and the dates. P1’s patient information report dated 3/9/23, did not identify any psychiatric assessments, medication side effects, medication compliance or treatment goals during the visit. Medical monitoring was competed. P1’s medications were set-up from 3/9/23 through 3/23/23, including Clozaril and Cymbalta. Clinical psychiatry note dated 3/10/23, indicated P1 had an error with medication set-up, missed Cymbalta, Clozaril and Chantix, which was realized 3/9/23. P1's thoughts of suicidal ideation, self-injurious behaviors have worsened. P1 came really close to self-injury on 3/9/23 but did not act on it, she felt like her brain was being shocked and zapped. P1 had increased nightmares, restlessness, more jittery, increased command hallucinations, difficulty with sleep, nausea, diarrhea, urinary urgency, some confusion, and vivid dreams. Daughter-in-law noticed in the past week P1 has been more agitated, anxious, and not sleeping. P1’s social worker was at the visit with P1, where concerns of the medication errors were brought up. P1 has been Clozapine and Cymbalta and has been experiencing symptoms of anticholinergic rebound from abrupt discontinuation of Clozapine. P1 had been experiencing discontinuation syndrome from abrupt discontinuation of Cymbalta. P1 has been experiencing significant worsening of command auditory hallucinations to harm or kill herself. Clozapine last dispensed 12/29/22, clozapine level drop from 982 ng/ml to <25 ng/ml and the Cymbalta was last dispensed 1/26/23. P1 reported to psychiatrist that when the error was noted at the nursing visit on 3/9/23, the nurse obtained Clozaril and set-up 450 mg in her med set, which she took 3/9/23. P1 was advised to not take any Clozapine 3/10/23, due to risk with resuming a high dose. Titration dose given. Family aware and is setting-up medications and if family notices any cognitive changes, encouraged them to take P1 to the emergency department. The lack of Clozapine is evidenced in lab work showing a profoundly low level. With an abrupt discontinuation of Cymbalta from 90 mg she was also experiencing antidepressant discontinuation syndrome on top of above-mentioned symptoms which includes feeling jittery, restlessness, feeling of electrical shocks/zaps throughout her body, difficulty sleeping. A psychiatry staff registered nurse (RN), contacted the HHA on 3/10/23, to request a medication administration record or other documentation. The psychiatry staff RN spoke with RN-A who is an agency Clinical Supervisor, several times but outpatient psychiatry did not receive any documentation of what happened or if there was any attempt to contact the psychiatry office. A home health agency report titled Complaint Report dated 3/13/23, indicated RN-A recorded a complaint on 3/13/23 at 7:30 a.m. regarding P1. The description of the complaint indicated a registered nurse (RN) from P1’s mental health provider office called and stated P1’s medications were set-up incorrectly. The provider reported P1’s Abilify injection was given a week late, Clozaril and Cymbalta was not given as ordered, possibly not set-up for a week or two. P1 was experiencing symptoms and may need to be taken to the emergency department. The home health agency reviewed P1’s medication set-up records for the past six weeks and all records show medication were set-up as ordered, except the medication records for the 2/25/23 visit did not have the detailed documentation which RN-A identified a nurse who completed the set-up forgot to create a note, RN-A provided education the nurse. Interventions regarding the complaint included education/retraining to a staff member and follow-up with the provider. An email dated 4/3/23 from P1’s psychiatrist indicated she was informed P1 was admitted to a hospital due her psychiatric symptoms that could not be managed safely at home and was related to the “medication error”. Upon observation on 3/23/23, at 9:30 a.m. RN-C inquired about P1's sleep pattern, and P1 stated she got three hours of sleep the night before. RN-C failed to look at P1's sleep log or provide any education. P1's weight was 301 lbs. RN-C stated the weight was "up," but could not state what P1's weight should be, only if her weight is up by 2 lbs. in 1 day to take "an extra Lasix." RN-C and P1 both stated P1 will set-up her own "extra Lasix," but does not always take her weight every day. RN-C assessed P1's oxygen saturation rate to be 93%, RN-B did not know what P1's parameters were. RN-C advised P1 to increase her fluid intake to "push out the fluids". P1 stated "I was told by my provider to not drink so much water." RN-C's response was "yeah that is probably right, do what she says." P1's vital signs were 132/72, RN-C was not aware of the specific parameters for P1. RN-C asked P1 If she had any concerns or complaints. P1 stated she was still having sleep problems and suicidal ideation. RN-C asked her if she still has the suicide hotline numbers and provided P1 with the agency after hours number. RN-C did not inquire if P1 had a suicidal plan, and no formal mental health assessment was completed. In addition, P1 stated, she still gets so anxious she cannot settle her legs down. RN-C's response was "that is tough, I am sorry for what you have been going through." Upon interview on 3/22/23, 9:36 a.m. P1 stated “my agency messed up my meds.” She stated she was not certain how long she had been without her medications but stated it “gets confusing” as sometimes she has three different medication boxes set-up in her home as the home as the agency comes out every other week. She stated she started to unravel, but could not figure out why, her legs were shaking, her mind was racing and was “being careless,” she did not care if she lived, she had many ideas of how to harm herself. P1 reported 2-3 hours of sleep a night, she joined a health club and reported she had diarrhea for a week. Her daughter-in-law locked up her medications and all the knives in the house. When her son and daughter-in-law, who live with her, went to work on their overnight shifts, family member (FM-A) had P1 stay with her father so she would always have supervision. P1 was in contact with her psychologist during this time and called the crisis line multiple times. P1 stated she has always been compliant in taking her medications because they have kept her stable. She did question that it appeared she had less medications but did not think any of it and did not have a detailed medication list to follow. P1 stated, I do not know if I can trust the agency, my daughter-in-law has really stepped up and fixed the problem. The agency did not come out and perform a visit when they heard that my Clozaril level had a significant drop. P1 stated that some of the agency nurses come in and just set-up her medications, other nurses take her vital signs, some inquire about her weight, some check her legs and feet and other do not. “I don’t know what they are supposed to be doing.” P1 does not recall an exact date a post-it note was left on her medication box. She stated some nurses leave her a note of what to fill, others just tell her pick-up her medications and place them in the boxes. P1 denied any education on medication set-up from the HHA. Upon interview on 3/22/23, at 11:33 a.m., a pharmacist stated P1’s last refill of Clozaril was 12/30/23, she had a lab draw on 1/30/23, but no refill request. Her next Clozaril dose was filled 3/15/23 with a titration order. “She went most of February and half of March without Clozaril.” “Her Cymbalta was last filled on 1/26/23, so I am assuming she has missed doses of that as well.” Upon interview on 3/22/23, at 2:10 p.m., the agency Registered Nurse (RN)-B stated that she completed a visit on 1/26/22, this was her last visit with P1 as the agency was changing branches. RN-B stated P1 receives services for her mental health. The agency performs medication set-up, weight monitoring, psychiatric assessments, physical assessments including diabetic education. The agency also administers P1's monthly Abilify medication injections. Upon interview on 3/22/23, at 3:30 p.m., RN-D stated she only saw P1 once and during the visit she was to assess P1's cognition, medication compliance and medication reconciliation. RN-D stated she was not aware of the side-effects of P1's medications, however the agency software program has the education staff should be looking at with any questions for medications, she denied using this resource for P1. RN-D stated she did not go through any formal assessment questions when seeing P1. RN-D stated she measured P1 vital signs and P1 was alert and oriented, she denied any other assessments. Upon interview on 3/22/23 at 4:12 p.m. RN-C for P1's visits the nurse set-up medications and reorders them, they also give her a monthly Abilify medication injection. RN-C stated she follows the plan of care, "it should tell us in the plan what to do." RN-C stated if the agency was supposed to do anything with Clozaril lab levels it should be on the care plan, and she did not recall hearing of any lab values needed. Upon interview on 3/23/23, at 10:55 a.m. P1’s psychologist stated P1 notified her on 3/9/23, that her HHA nurse realized she had not been getting her Clozaril in her past medication set-ups. The psychologist stated P1 first reported she was feeling “off” on 2/27/23. On 3/1/23, P1 was reporting no sleep for days, increased auditory hallucinations, suicidal ideation and thoughts of self-harm, no plan, but definite thought of method, psychomotor agitation, racing thoughts and increased self-directed energy. The psychologist stated he has worked with P1 for 16 months and this was the first time I have seen any symptoms. On 3/9/23, P1 was reporting her brain felt like a static globe and felt electric shocks, but her body felt tired. P1 was instructed to go to the emergency room. P1 had a psychiatry appointment the following day. Upon interview on 3/23/23, at 3:01 p.m. LPN-A stated on 3/9/23, he completed a visit on P1. He stated this was the first time he had seen her, so he was not familiar with her medications. LPN-A stated he does systems check of all the clients upon each visit and assesses the client's cognition. He could not recall any specific assessments or interventions for P1. Upon interview on 3/23/23, at 3:16 p.m. RN-A stated after he received a call from P1’s psychiatrist on 3/13/23 [SIC] that P1’s Clozaril level was profoundly low and has not been dispensed since 12/29/22 [SIC], it was likely P1 has not been receiving Clozaril since late January. RN-A stated he was not aware that there was a concern P1 was not receiving her prescribed Cymbalta. RN-A was not aware of any assessment the nursing staff is doing for P1’s schizoaffective disorder and Clozaril use. RN-A was not aware that Clozaril required a lab level and did not have knowledge about the REM program. Upon interview on 3/23/23, at 3:53 p.m. RN-F stated she was told by RN-A that there was a concern of possible missed medication. RN-F stated her expectations were if a medication could not be filled the agency nurse should notify the provider, call the pharmacy, follow-up with the patient, and do an as needed nursing visit if needed. RN-F stated missing Clozaril is a significant medication error. RN-F was not aware P1 was not receiving her prescribed Cymbalta. RN-F stated her expectation of the staff is that the care plan is followed at each visit and each patient should have parameters set for them to progress towards their goals and so the nurses can education to achieve the goals. The agency policy titled Vulnerability Reporting indicated neglect means the failure or omission by a caregiver to supply a vulnerable adult with care or services including but not limited to food, clothing, shelter, healthcare, or supervision which is reasonable and necessary to obtain or maintain the vulnerable adults physical or mental health or safety, considering he physical and mental capacity or dysfunction of the vulnerable adult. An agency policy titled Medication Error, dated 5/10/21 indicated an Unusual Occurrence Report is to be completed for all medication errors. Information gathered regarding medication errors will be tracked and analyzed as part of the company’s performance improvement plan. A medication error was defined as missing a scheduled administration of a medication or any reason, e.g., staffing difficulties, equipment, supplies. A significant medication error was defined any error that requires or results in the following, discontinuing a medication or modifying dose, treatment with a prescribed medication and cognitive deterioration or impairment. If the error is one of omission, follow the corrected medication schedule after discussing with the physician and pharmacist as appropriate. Document the events of the error objectively in the client’s clinical record. An agency policy titled Medication management dated 6/8/22, indicated a clinically significant medication issues would be omissions, dosage errors and impairment or decline in a patient’s mental or physical condition. An agency policy titled Initial Assessment/Certification dated 4/8/21, indicated the assessment facilitates the identification and prioritization of the patient needs, goals, and plan of care.

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 interviews and document review, the facility failed to thoroughly investigate a complaint made to the home health care agency for 2 of 3 patients (P1, and P2) reviewed. The agency was informed of a medication error for P1 on 3/10/23, began an investigation on 3/13/23, and did not complete a thorough investigation. The agency did not contact P1 until a routine assessment on 3/21/23. In addition, the agency failed to do any investigation on a complaint reported from a county case worker for P2. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23 to 3/21/23, indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. P1’s orders of discipline and treatments. 1. Skilled nurse (SN) for instruction/reinforcement of diabetic care to include diet, skin care, administration of insulin, blood glucose testing and diabetic foot care. 2. SN to provide skilled teaching/reinforcement of management of hypertension. 3. SN to review medication profile and reconcile medications as needed, SN may instruct and reinforce medication teaching related to use of medications to treat disease process, SN may fill medication orders/profile bi-weekly. 4. Skilled nurse for observation/assessment of patient’s impaired nutrition related to obesity, instruction patient/caregiver on interventions designed to improve nutritional intake and patient well-being. 5. SN for administration of ability via IM injection every month. 6. SN to perform multifactor fall risk assessment and implement interventions to decrease risk of falls. SN to instruct on home safety, impact of polypharmacy, environmental safety and fall prevention. 7. SN to evaluate and develop plan of care to be countersigned by physician, SN to assess/evaluate co-morbid conditions including schizoaffective disorder and other conditions that present themselves while this episode to identify changes and intervene to minimize complications. 8. SN to observe and assess cardiovascular system to identify changes and intervene to minimize complications. SN to provide skilled teaching related to altered cardiovascular status including pathophysiology, nutrition, medication regimen, and permitted activities. May perform oxygen saturation levels as needed for signs and/or symptoms of possible respiratory complications. 9. SN to provide instructions related to management of congestive heart failure including, but not limited to definition, risk factors, measures to prevent exacerbation, signs/symptoms, and potential complications. 10. SN to monitor plan for current treatment of depression such as effects of medication and/or need for referral for other treatment. 10. All orders disciplines will assess for vulnerability/maltreatment concerns/changes, review the vulnerable/abuse prevention plan, facilitate patient advocacy, notify physician/nurse practitioner and/or refer to MAARC/county common entry point as appropriate for changes/concerns in vulnerability/maltreatment. 11. All ordered disciplines will implement the individual vulnerability/maltreatment/abuse prevention plan, self-management, personal safety, implement pathway, need for skilled care related to fall risk and or behavior and or need for other disciplines. 12. Self-management, medication set-up/management, implement pathways, medication management, assess for medication compliance and alert physician of significant issues/missed doses. Teach patient/caregiver how to set-up medications. Teach medication reminders including alarms. Clinical psychiatry note dated 3/10/23, indicated P1 had an error with medication set-up, missed Cymbalta, Clozaril and Chantix, which was realized 3/9/23. P1's thoughts of suicidal ideation, self-injurious behaviors have worsened. P1 came really close to self-injury on 3/9/23 but did not act on it, she felt like her brain was being shocked and zapped. P1 had increased nightmares, restlessness, more jittery, increased command hallucinations, difficulty with sleep, nausea, diarrhea, urinary urgency, some confusion, and vivid dreams. Daughter-in-law noticed in the past week P1 has been more agitated, anxious, and not sleeping. P1’s social worker was at the visit with P1, where concerns of the medication errors were brought up. P1 has been Clozapine and Cymbalta and has been experiencing symptoms of anticholinergic rebound from abrupt discontinuation of Clozapine. P1 had been experiencing discontinuation syndrome from abrupt discontinuation of Cymbalta. P1 has been experiencing significant worsening of command auditory hallucinations to harm or kill herself. Clozapine last dispensed 12/29/22, clozapine level drop from 982 ng/ml to The description of the complaint indicated a registered nurse (RN) from P1’s mental health provider office called and stated P1’s medications were set-up incorrectly. The provider reported P1’s Abilify injection was given a week late, Clozaril and Cymbalta was not given as ordered, possibly not set-up for a week or two. P1 was experiencing symptoms and may need to be taken to the emergency department. The home health agency reviewed P1’s medication set-up records for the past six weeks and all records show medication were set-up as ordered, except the medication records for the 2/25/23 visit did not have the detailed documentation which RN-A identified a nurse who completed the set-up forgot to create a note, RN-A provided education the nurse. Interventions regarding the complaint included education/retraining to a staff member and follow-up with the provider. Upon interview on 3/22/23, at 10:43 a.m. P1 stated the agency did not reach out to her following the allegations. The agency did not call or provide a visit to until 3/21/23, which was a recertification visit. Upon interview on 3/22/23, at 3:18 p.m. RN-A stated receiving a call from the providers office. RN-A stated following the call he reviewed P1’s visit notes and did not see that any medications were missed. However, 2/25/23, RN-D did not document correctly. RN-A made a call to RN-D and RN-D confirmed all the medications were set-up on 2/25/23. RN-A denied reaching out to the P1, denied reaching out to the pharmacy. RN-A stated he was not aware that Clozaril required a lab draw, was a significant medication and could not be filled until lab work was completed. Upon interview on 3/23/23, at 3:53 p.m. RN-F, Director of Clinical Programs, stated she was aware there were allegations of “possibly missed set-up medications.” She stated she believed the allegations were taken care of until the state agency (SA) came onsite to investigate. RN-F was starting her own investigation of the allegations. P2’s (POC) dated 2/9/23, indicated R2’s diagnoses included chronic pain syndrome, polyneuropathy (numbness and weakness of multiple nerves), generalized anxiety disorder, post-traumatic stress disorder and occlusion and stenosis of the left carotid artery. R2’s frequency of visits was for weekly skilled nursing. 1. SN to evaluate and develop plan of care to be countersigned by physician, SN to assess/evaluate co-morbid conditions including schizoaffective disorder and other conditions that present themselves while this episode to identify changes and intervene to minimize complications. 2. SN to perform multifactor fall risk assessment and implement interventions to decrease risk of falls. 3. Skilled nursing to perform observe and assess patient with generalized depression. Assess need for medication, medication changes, and potential need for referral to provide counseling and assistance with managing depression. 4. All orders disciplines will assess for vulnerability/maltreatment concerns/changes, review the vulnerable/abuse prevention plan, facilitate patient advocacy, notify physician/nurse practitioner and/or refer to MAARC/county common entry point as appropriate for changes/concerns in vulnerability/maltreatment. 5. Self-management, medication set-up/management, implement pathways, medication management, assess for medication compliance and alert physician of significant issues/missed doses. 6. Skilled assessment to evaluate patient for maladaptive, aggressive, noncompliant, self-harming, and/or abusive behaviors. Assess medication treatment compliance, need for medication changes, and potential need for referral to a provider for counseling/assistance with managing behaviors. Provide skilled teaching to promote personal safety, reduce maladaptive behaviors and improve daily health practices. Report to significant concerns in behaviors to physician or nurse practitioner for interventions. 7. SN to review medication profile and reconcile medications as needed, SN may instruct and reinforce medication teaching related to use of medications to treat disease process, SN may fill medication orders/profile every Thursday. 8. SN to monitor plan for current treatment of depression such as effects of medication and/or need for referral for other treatment. 9. SN to provide/instruct regarding interventions to monitor and mitigate pain. 10. Licensed professional to report vital signs falling outside the following established parameters. Temp 101, pulse 100, respirations 29, systolic blood pressure 100, diastolic blood pressure 90. R2’s Patient Information Record dated 3/15/23, indicated R2’s county case manager, called RN-A requesting only a female nurse to do the visits due to R2’s past drama. Upon interview on 3/22/23, at 1:44 p.m. P2 stated on 3/9/23, LPN-A showed-up to visit P2 and she became very anxious, fearful, and got “emotional” with LPN-A. “I was just scared, very scared, they know my history and I refused this visit.” Upon interview on 3/22/23, At 3:18 p.m. RN-A, stated he did receive a complaint from R2’s county case manager about not allowing male nurses to visit P2 due to the post-traumatic stress disorder related to the violent past with a male perpetrator. RN-A denied awareness of P2’s diagnosis. RN-A stated he did not fill out a complaint report, update staff, reach out to P2 or update the visit schedule to include only female staff. Upon interview on 3/23/23, at 3:53 p.m. RN-F stated she was unaware of any complaints regarding P2, however stated there should have been an incident written up and investigated. A facility policy titled Client Incident, Accident, Injury, or Unusual Occurrence dated 4/17/18 indicated the supervisor should review the Unusual Occurrence Report and determine the factors which contributed to the occurrence and complete the required documentation. The completed Unusual Occurrence Report should be submitted to the Branch General Manger for review and investigation if necessary.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: The Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients at G536 was found not met. The agency failed to identify the potential adverse effects with the drug therapy Clozaril, an antipsychotic medication, and Cymbalta, an antidepressant for 1 of 1 patient (P1) reviewed for medication. P1's Clozaril medication was not ordered, set-up, and reconciled as prescribed. P1 went without Clozaril for approximately 45 days, psychiatrically decompensated, and was hospitalized. In addition, P1 went without Cymbalta for approximately 45 days.

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 interview and document review the agency failed to identify the potential adverse effects with the drug therapy Clozaril, an antipsychotic medication, and Cymbalta, an antidepressant for 1 of 1 patient (P1) reviewed for medication. P1's Clozaril medication was not ordered, set-up, and reconciled as prescribed. P1 went without Clozaril for approximately 45 days, psychiatrically decompensated, and was hospitalized. In addition, P1 went without Cymbalta for approximately 45 days. U.S. Food and Drug Administration (FDA) website https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s084lbl.pdf for Clozaril prescribing information indicated Clozaril is an atypical antipsychotic medication used for the treatment of resistant schizophrenia, reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Clozaril is indicated for treatment of patients who fail to respond adequately to standard antipsychotic treatment. Doses start at 12.5 mg once or twice daily and to use caution with titration increasing to total daily dosage in increments of 25 milligrams (mg) to 50 mg if well tolerated with a maximum daily dose of 900 mg. Clozaril is a high risk medication that can cause severe neutropenia, orthostatic hypotension, bradycardia, syncope, seizure, myocarditis, cardiomyopathy, and increased mortality in elderly patients with dementia-related psychosis. The following warnings and precautions include eosinophilia, QT interval prolongation, metabolic changes such as hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain, neuroleptic malignant syndrome, hepatotoxicity, fever, pulmonary embolism, anticholinergic toxicity, and interference with cognitive and motor performance. Clozaril has caused neutropenia leading to serious infection and death when a patients absolute neutrophil count (ANC) is less than 500 microliters (ul). Prior to initiating treatment, a patient's ANC baseline must be at least 1500 ul. During treatment, patients must have regular ANC monitoring. Patients are to immediately report symptoms consistent with severe neutropenia or infection, e.g., fever, weakness, lethargy, or sore throat. Patients responding to Clozaril should continue maintenance treat of their effective dose beyond the acute episode. Abruptly discontinuing Clozaril is necessary only as a result of moderate to severe neutropenia, a gradually dose reduction should be planned over a period of 1 to 2 weeks with additional ANC monitoring and all patients should be carefully monitored for the recurrence of psychotic symptoms and symptoms related to cholinergic rebound such at profuse sweating, headache, nausea, vomiting, and diarrhea. Re-initiation of Clozaril treatment after a patient has discontinued Clozaril for 2 days or more since last dose is to reinitiate with 12.5 mg once or twice daily, if well tolerated the dose may be increased to the previously dose more quickly. Clozaril is only available through a restricted program under a Risk Evaluation and Mitigation Strategies (REMS) program because of the risk of severe neutropenia. Healthcare professionals who prescribe, patients who receive, and pharmacies dispense Clozaril must be enrolled and/or certified in the program. Patient and caregiver counseling information include the risks and warnings of taking Clozaril, reporting any symptoms to their provider, any potential drug to drug interactions of prescribed or over-the-counter medications. U.S. Food and Drug Administration (FDA) website https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf for Cymbalta prescribing information indicated Cymbalta is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. Dosage of Cymbalta was based on the indication for use. Warnings and precautions included Discontinuation Syndrome indicate patients should be monitored for symptoms when discontinuing treatment, a gradual reduction dose rather than abrupt cessation is recommended whenever possible. Additional warnings included hepatotoxicity, orthostatic hypotension, falls, syncope, serotonin syndrome, increased risk of bleeding, sever skin reactions, activation of mania or hypomania, angle-closure glaucoma, seizures, blood pressure increases, inhibitors of CYP1A2 or Thioridazine, hyponatremia, or condition that slow gastric emptying. The medication guide indicated topics on telling your healthcare provider right away of symptoms and feelings listed, what is Cymbalta, who should not take Cymbalta, how should you take it, and what you should avoid while taking Cymbalta, medical conditions to tell your provider, and side effects. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23, indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. P1’s orders of discipline and treatments. 1. Skilled nurse (SN) for instruction/reinforcement of diabetic care to include diet, skin care, administration of insulin, blood glucose testing and diabetic foot care. 2. SN to provide skilled teaching/reinforcement of management of hypertension. 3. SN to review medication profile and reconcile medications as needed, SN may instruct and reinforce medication teaching related to use of medications to treat disease process, SN may fill medication orders/profile bi-weekly. 4. Skilled nurse for observation/assessment of patient’s impaired nutrition related to obesity, instruction patient/caregiver on interventions designed to improve nutritional intake and patient well-being. 5. SN for administration of ability via IM injection every month. 6. SN to perform multifactor fall risk assessment and implement interventions to decrease risk of falls. SN to instruct on home safety, impact of polypharmacy, environmental safety and fall prevention. 7. SN to evaluate and develop plan of care to be countersigned by physician, SN to assess/evaluate co-morbid conditions including schizoaffective disorder and other conditions that present themselves while this episode to identify changes and intervene to minimize complications. 8. SN to observe and assess cardiovascular system to identify changes and intervene to minimize complications. SN to provide skilled teaching related to altered cardiovascular status including pathophysiology, nutrition, medication regimen, and permitted activities. May perform oxygen saturation levels as needed for signs and/or symptoms of possible respiratory complications. 9. SN to provide instructions related to management of congestive heart failure including, but not limited to definition, risk factors, measures to prevent exacerbation, signs/symptoms, and potential complications. 10. SN to monitor plan for current treatment of depression such as effects of medication and/or need for referral for other treatment. 10. All orders disciplines will assess for vulnerability/maltreatment concerns/changes, review the vulnerable/abuse prevention plan, facilitate patient advocacy, notify physician/nurse practitioner and/or refer to MAARC/county common entry point as appropriate for changes/concerns in vulnerability/maltreatment. 11. All ordered disciplines will implement the individual vulnerability/maltreatment/abuse prevention plan, self-management, personal safety, implement pathway, need for skilled care related to fall risk and or behavior and or need for other disciplines. 12. Self-management, medication set-up/management, implement pathways, medication management, assess for medication compliance and alert physician of significant issues/missed doses. Teach patient/caregiver how to set-up medications. Teach medication reminders including alarms. P1’s treatment orders failed to identify any parameters for P1’s blood glucose levels, vital signs, and weight monitoring. In addition, the POC failed to identify Clozaril assessments, lab draws, missed doses, provider notification, and side effects. P1’s therapeutic level of Clozaril indicated the following lab values. A normal therapeutic range for the use of Clozaril was 350-600 ng/ml. lab level dated 1/3/23 indicated a level of 910 nanograms/milliliter (ng/ml) lab level dated 1/31/23 indicated a level of 952 ng/ml lab level dated 3/7/23, was lab level dated 3/16/23 was 101 ng/ml P1’s patient information report dated 1/26/23, indicated all P1’s medications were set-up from 1/26/23 through 2/8/23, including Clozaril and Cymbalta. The note did not indicate any refills were ordered or P1 was short of any medications or instructions given to P1 to picking and fill medications on her own. P1’s patient information report dated 2/9/23, indicated all P1’s medications were set-up from 2/9/23 – 2/23/23, including Clozaril and Cymbalta. The note indicated Clozaril, duloxetine and ropinirole were called into pharmacy for a refill. The note failed to indicate any instructions given to P1 regarding the medications called into pharmacy. P1’s patient information report dated 2/27/23, indicated P1 was seen on 2/25/23 with a narrative note indicating no changes to the medication regimen. The note failed to provide a list of the medications set-up and the dates. P1’s patient information report dated 3/9/23, indicated all P1’s medications set-up from 3-9-23 through 3/23/23, including Clozaril and Cymbalta. Refills ordered were Clozaril, Cymbalta, gabapentin, and celecoxib. The note failed indicate licensed practical nurse (LPN)-A could not find P1’s Clozaril, so he looked in her medication tote and found a bottle of 50 mg tables, where on the bottle it said, “do not use.” He used this bottle to fill “around 400 or 450 mg of the medication” to fill a couple of days until P1 could get her refill. Clinical psychiatry note dated 3/10/23, indicated there was an error with P1’s medication set-up, missed Cymbalta, Clozaril and Chantix, this was realized yesterday. Thoughts of suicidal ideation, self-injurious behaviors have worsened, came really close to self-injury on Wednesday but did not act on it. P1 felt like her brain was being shocked and zapped P1 had increased nightmares, restlessness, was more jittery, increased command hallucinations, difficulty with sleep, nausea, diarrhea, urinary urgency, some confusion, and vivid dreams. Daughter-in-law noticed in the past week P1 has been more agitated, anxious, and not sleeping. P1’s social worker was at the visit with P1, where concerns of the medication errors were brought up. P1 had been Clozapine and Cymbalta and had experienced symptoms of anticholinergic rebound from abrupt discontinuation of Clozapine. P1 had been experiencing discontinuation syndrome from abrupt discontinuation of Cymbalta. P1 had been experienced significant worsening of command auditory hallucinations to harm or kill herself. Clozapine last dispensed 12/29/22 [SIC], clozapine level drop from 982 ng/ml to 12/30/22, she had a lab draw on 1/30/23, but no refill request. Her next Clozaril dose was filled 3/15/23 with a titration order. “She went most of February and half of March without Clozaril.” “Her Cymbalta was last filled on 1/26/23, so I am assuming she has missed doses of that as well.” Upon interview on 3/22/23, at 2:10 p.m., the agency Registered Nurse (RN)-B stated that she completed a visit on 1/26/22, this was her last visit with P1 as the agency was changing branches. She stated she did run out of two medications during the medication set-up. RN-B could not recall the names of the medications, but stated one was an anti-psychotic and one was an antidepressant. She stated she may have charted incorrectly that all medications were set-up as she automatically put in the dates the medications. RN-B stated sometimes she charts her medication set-up in the home and other times after the visit. She stated she is able and has copied and pasted medications and then puts in the dates to save time. RN-B stated on 1/26/23 she was short about 4-5 day of the "anti-psychotic and the antidepressant," she stated she left a post-it note on P1's medication set box to fill in the missing medications when she picked them up from the pharmacy. RN-B could not recall if she ordered refills. RN-B stated she did not reach out to the ordering provider that P1 did not have enough medications to complete the medication set-up. RN-B was aware that Clozaril required lab results prior to refilling but did not discuss with P1. RN-B denied follow-up with P1 to see if medications were refilled and set-up. RN-B did not believe that P1 had been educated on setting-up her own medication. “I haven’t seen any formal documentation in the agency on any patients.” Upon interview on 3/23/23, at 10:55 a.m. P1’s psychologist stated P1 notified her on 3/9/23, that her HHA nurse realized she had not been getting her Clozaril in her past medication set-ups. The psychologist stated P1 first reported she was feeling “off” on 2/27/23. On 3/1/23, P1 was reporting no sleep for days, increased auditory hallucinations, suicidal ideation and thoughts of self-harm, no plan, but definite thought of method, psychomotor agitation, racing thoughts and increased self-directed energy. “I have worked with her for 16 months and this was the first time I have seen any symptoms of bipolar”. On 3/9/23, P1 was reporting her brain felt like a static globe and felt electric shocks, but her body felt tired. P1 was instructed to go to the emergency room. P1 had a psychiatry appointment the following day. The psychologist asked why the HHA did not reach out to her regarding the increase in psychiatric symptoms? Upon interview on 3/23/23, at 3:01 p.m. LPN-A stated on 3/9/23, he completed a visit on P1. He stated this was the first time he had seen her, so he was not familiar with her medications. He stated he filled her medications. He remembered he could not find her anti-psychotic, so he looked in her medication tote and found a bottle of 50 mg tables, where on the bottle it said, “do not use.” He used this bottle to fill “around 400 or 450 mg of the medication.” He stated he had enough medications to use “9 or 10 tablets to make the dose” of this medication and was able to “make the dose” to fill a couple of days until P1 could get her refill. LPN-A does not recall having a conversation with RN-A about P1 not having the medications prior to his visit. P1 stated he was not aware that Clozaril required a lab level prior to refills and was not certain exactly what assessments he should be doing a patient on Clozaril. LPN-A stated he gave P1 instructions to fill her medication box when she picked up her medications. LPN-A stated he was not certain if P1 was educated to set-up her medications. He stated, “If I had concerns if a patient could be trusted to set-up their own medications, I would visit with them and see where they were at cognitively and if they were safe to set-up their own medications and she seemed safe.” LPN-A stated he did not notify the physician following the visit. Upon interview on 3/23/23, at 3:16 p.m. RN-A stated after he received a call from P1’s psychiatrist on 3/13/23 [SIC], that P1’s Clozaril level was profoundly low and has not been dispensed since 12/29/22 [SIC],it is likely P1 has not been receiving Clozaril since late January about the complaint. P1 denied awareness that there was a concern about P1’s Cymbalta as well. RN-A stated he reached out to LPN-A and asked if P1’s Clozaril had been set-up on 3/9/23. LPN-A told RN-A that he used 25 mg [SIC] tablets to fill in the dose. RN-A stated he could not explain why the agency nurses documented the medication was given, and P1’s lab level was >25 ng/ml and the pharmacy indicated the medication was not filled since 12/30/23. RN-A was not aware of any assessment the nursing staff is doing for P1’s schizoaffective disorder and Clozaril use. RN-A was not aware that Clozaril required a lab level and did not have knowledge about the REM program. Upon interview on 3/23/23, at 3:53 p.m. RN-F stated she was told by RN-A that there was a concern of possible missed medication. RN-F stated there is a list of high-risk medications that all the agency nurses need to be aware of and Clozaril is on that list. She stated all the nurses have access to the Lippincott medication library right in the software systems, so the nurses should be accessing that. RN-F stated her expectations were if a medication could not be filled per provider until the next visit, the agency nurse should notify the provider, call the pharmacy, follow-up with the patient and do an as needed nursing visit if needed. RN-F stated missing Clozaril is a significant medication error. RN-F was unable to state why the agency staff was documenting all medications were set-up and the pharmacy was saying there had not been a refill since 12/30/23 and her lab level came back at >25 ng/ml. RN-F was not aware there was a Cymbalta medication error. An agency policy titled Medication Error, dated 5/10/21 indicated an Unusual Occurrence Report is to be completed for all medication errors. Information gathered regarding medication errors will be tracked and analyzed as part of the company’s performance improvement plan. A medication error was defined as missing a scheduled administration of a medication or any reason, e.g., staffing difficulties, equipment, supplies. A significant medication error was defined any error that requires or results in the following, discontinuing a medication or modifying dose, treatment with a prescribed medication and cognitive deterioration or impairment. If the error is one of omission, follow the corrected medication schedule after discussing with the physician and pharmacist as appropriate. Document the events of the error objectively in the client’s clinical record. An agency policy titled Medication management dated 6/8/22, indicated a clinically significant medication issues would be omissions, dosage errors and impairment or decline in a patient’s mental or physical condition.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure the plan of care (POC) included a description of the risk for emergency department visits and hospital re-admission, advanced directives, and/or education, including all necessary interventions to address the underlying risk factors, and identify parameters for goals and education for 2 of 3 patients (P1 and P2) reviewed. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23 indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, morbid obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. P1’s orders of discipline and treatments. The POC failed to identify advanced directives, DME and supplies and a description of the risk for emergency department visits and hospital re-admission, including all necessary interventions to address the underlying risk factors as required so the provider was aware of all risks, interventions, and orders. In addition, the POC indicated skilled nursing for a treatment completed administration of insulin, P1’s medication profile dated 1/20/23, does not indicate P1 takes insulin. The POC failed to identify any parameters for P1’s blood glucose levels, vital signs, and weight monitoring. P2’s (POC) dated 2/9/23 indicated P2’s diagnoses included chronic pain syndrome, polyneuropathy (numbness and weakness of multiple nerves), generalized anxiety disorder, post-traumatic stress disorder and occlusion and stenosis of the left carotid artery. P2’s frequency of visits was for weekly skilled nursing. The POC failed to identify advanced directives, DME and supplies and a description of the risk for emergency department visits and hospital re-admission, including all necessary interventions to address the underlying risk factors as required so the provider was aware of all risks, interventions, and orders. An agency policy titled Initial Assessment/Certification dated 4/8/21, indicated the assessment will include an evaluation of the following: Patient’s medical history, pertinent physical findings, problems and goals, need for strengths, psychosocial status, nutritional status, prevent of advanced directives, equipment presently in the home, medications, patient support systems, involvement of family/caregiver and other support, medical, alcohol and other drug history, preventative ad period health screening, specific, individualized patient needs/problems pertinent to the care provided, age and gender specific findings, home environment, education needs, vulnerability and emergency plan.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on interview and document review, the agency failed to provide medications as ordered by the patient's physician for 1 of 3 patients (P1) reviewed, when nursing staff failed to set-up the patient's anti-psychotic medication and anti-depressant medications as ordered and did not notify the provider. This practice caused P1 to go without her anti-psychotic medication for over a month, leading to abnormal lab values, and increased mental health symptoms. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23, indicated P1s diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. R1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. R1’s orders of discipline and treatments. P1's medications included clozapine (an anti-psychotic medication) 200 mg 2 tablets in the morning for a total of 400 mg. P1's treatments included skilled nursing which included that during every skilled nurse visit, the nurse was to perform medication management, including medication set-up, refill ordering, and compliance monitoring. An outpatient lab result dated 3/6/23, indicated an abnormal lab for Clozapine level of <25 nanograms per milliliter (ng/ml). Normal range is 350 – 600 ng/ml. A clinical psychiatry visit note dated 3/10/23, indicated an error with medication set-up. P1 missed Cymbalta (an anti-depressant), Clozapine (anti-psychotic) and Chantix (smoking cessation). The note indicated P1s thoughts of suicidal ideation and serious injurious behavior have worsened. P1 feels like her brain is being shocked with zaps. P1 was suffering from increased nightmares, restless, more jittery, increased command hallucinations, difficulty with sleep, nausea, diarrhea, urinary urgency, some confusion, and vivid dreams. Upon interview on 3/22/23, at 11:33, a pharmacist stated P1’s last refill of Clozaril was 12/30/23, she had a lab draw on 1/30/23, but no refill request. Her next Clozaril dose was filled 3/15/23 with a titration order. “She went most of February and half of March without Clozaril.” “Her Cymbalta was last filled on 1/26/23, so I am assuming she has missed doses of that as well.” Upon interview on 3/22/23, at 2:10 p.m., the agency Registered Nurse (RN)-B stated that she completed a visit on 1/26/22, this was her last visit with P1 as the agency was changing branches. She stated she did run out of two medications during the medication set-up. RN-B could not recall the names of the medications, but stated one was an anti-psychotic and on was an antidepressant. She stated she may have charted incorrectly that all medications were set-up as she automatically put in the dates the medications should have been set-up for. RN-B stated sometimes she charts her medication set-up in the home and other times after the visit. She stated she is able and has copied and pasted medications and then puts in the dates filled. RN-B stated on 1/26/23 she was short about 4-5 day of the "anti-psychotic and the antidepressant," she stated she left a post-it note on P1's medication set box to fill in the missing medications when she picked them up from the pharmacy. RN-B could not recall if she ordered refills. RN-B stated she did not reach out to the ordering provider that she did not have enough medications to complete the medication set-up. RN-B was aware that Clozaril required lab results prior to refilling. RN-B denied follow-up with P1 to see if medications were refilled and set-up. Upon interview on 3/22/23, at 3:53 p.m. RN-F stated it is the expectation of the HHA for the nurse to call the provider if there is a concern of not having enough medications in the home and to follow-up with the patient if medication set-up is not completed in full during visit. An agency policy titled Medication Management, Home Care dated 5/19/22, indicated to notify the practitioner regarding any unresolved concerns regarding the patient’s medication regimen. An agency policy titled Medication Management, dated 6/8/22, indicated the client/caregiver will be instructed on special precautions for high-risk medications identified on the medication profile.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the facility failed to provide 1 of 3 patients (P1) and/or representatives a with a medication regimen, including medication name, dose and frequency and which medications will be set-up by the home health agency (HHA) in the patient’s home. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23, indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. P1’s orders of discipline and treatments. SN to review medication profile and reconcile medications as needed, SN may instruct and reinforce medication teaching related to use of medications to treat disease process, SN may fill medication orders/profile bi-weekly. SN for administration of ability via IM injection every month. Self-management, medication set-up/management, implement pathways, medication management, assess for medication compliance and alert physician of significant issues/missed doses. Teach patient/caregiver how to set-up medications. Teach medication reminders including alarms. Upon observation on 3/23/23, at 9:35 a.m. P1 had a large plastic unlocked tote with medications. In tote was a provider medication list dated 1/17/23. P1 also had a list of a Clozaril titration dated 3/10/23, from the provider. An agency medication profile list was not found. Upon interview on 3/23/23, at 11:17 a.m. P1 stated she did not have a medication list from the HHA in her home. She stated she would like a list, as there are times when she questions her medications and would like to perform her own reconciliation when she is having a question. Upon interview on 3/23/23, at 11:32 a.m. RN-C stated she has not left a printed medication sheet in P1’s home. RN-C was not certain if it was the agencies practice to have an updated medication list in the home or if the providers list was enough. Upon interview on 3/23/23, at 3:53 p.m. RN-E stated it was her expectation that patients have an updated medication profile in the home, especially since P1’s plan of care indicated to teach patient/caregiver how to set-up medications and P1 had multiple disciplines in the home. A facility policy titled Medication Management, home care dated 5/19/22, under the heading Patient Teaching, indicated the importance of keeping an accurate, up-to-date list of medications in the home and advise the patient to keep the medication list handy at all times in case of an emergency.

Other pertinent instructions CFR(s): 484.60(e)(4) Any other pertinent instruction related to the patient's care and treatments that the HHA will provide, specific to the patient's care needs. This ELEMENT is not met as evidenced by: Based on observation, interviews, and document review the home health agency (HHA) failed to provide 1 of 3 patients (P1) pertinent instruction related to the patient’s specific care needs. The plan of care and a crisis plan were not present P1’s home upon visit. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23, indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. P1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. P1’s orders of discipline and treatments. 1. Skilled nursing (SN) to review medication profile and reconcile medications as needed, SN may instruct and reinforce medication teaching related to use of medications to treat disease process, SN may fill medication orders/profile bi-weekly. 4. Skilled nurse for observation/assessment of patient’s impaired nutrition related to obesity, instruction patient/caregiver on interventions designed to improve nutritional intake and patient well-being. 5. SN for administration of ability via IM injection every month. 6. SN to perform multifactor fall risk assessment and implement interventions to decrease risk of falls. SN to instruct on home safety, impact of polypharmacy, environmental safety and fall prevention. 7. SN to evaluate and develop plan of care to be countersigned by physician, SN to assess/evaluate co-morbid conditions including schizoaffective disorder and other conditions that present themselves while this episode to identify changes and intervene to minimize complications. 8. SN to observe and assess cardiovascular system to identify changes and intervene to minimize complications. SN to provide skilled teaching related to altered cardiovascular status including pathophysiology, nutrition, medication regimen, and permitted activities. May perform oxygen saturation levels as needed for signs and/or symptoms of possible respiratory complications. 9. SN to provide instructions related to management of congestive heart failure including, but not limited to definition, risk factors, measures to prevent exacerbation, signs/symptoms, and potential complications. 10. SN to monitor plan for current treatment of depression such as effects of medication and/or need for referral for other treatment. 10. All orders disciplines will assess for vulnerability/maltreatment concerns/changes, review the vulnerable/abuse prevention plan, facilitate patient advocacy, notify physician/nurse practitioner and/or refer to MAARC/county common entry point as appropriate for changes/concerns in vulnerability/maltreatment. 11. All ordered disciplines will implement the individual vulnerability/maltreatment/abuse prevention plan, self-management, personal safety, implement pathway, need for skilled care related to fall risk and or behavior and or need for other disciplines. 12. Self-management, medication set-up/management, implement pathways, medication management, assess for medication compliance and alert physician of significant issues/missed doses. Teach patient/caregiver how to set-up medications. Teach medication reminders including alarms. Upon interview on 3/23/23, at 111:40 a.m. P1 stated she was not aware of everything her skilled nursing are to be completing on her nursing visits. She denied having an updated plan of care in her house following her re-certification assessments and/or any changes in her medical care. P1 stated the HHA nurses have advised her when she is having suicidal ideations or hallucinations to call her father, call psychiatrist and/or psychologist and to call or text the suicide hotline. P1 denied having a documented crisis plan from the HHA at any time. Upon observation on 3/23/22 at 9:30 a.m. P1 had an admission folder from the HHA. In the folder was signed forms including bill or rights, consent form, and service agreement. There was not a copy of P1’s plan of care or a crisis plan in the folder. Upon interview on 3/23/22, at 11:32 a.m. RN- C stated she did know of a documented crisis plan for P1 and was unaware if P1 had a plan of care in the home. Upon interview on 3/23/22, at 11:35 a.m. RN-G stated P1 had an emergency plan that she would provide to the surveyor, however, was not certain if P1 had a plan in the home or when a crisis had been updated and provided to the client. Upon interview on 3/23 at 3:53 p.m. RN-F stated it is her expectation that all the patient’s especially those diagnosed with mental illness have a crisis in the home and is an HHA expectation that every patient has their plan of care in the home. RN-F stated the agency is in a software transition and they are working getting a patient portal. An agency policy titled Initial Assessment/Certification dated 4/8/21, indicated findings are documented in the clinical record and may be placed in the patient’s home.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on interview and document review the home health agency (HHA) failed to involve an interdisciplinary approach from all health providers for involvement in the patient’s initial assessment, follow-up assessments, and plan of care for 1 of 3 patients (P1) reviewed. P1 was taking Clozaril, a high-risk anti-psychotic medication, and did not include P1’s psychologist and psychiatrist interventions, assessment expectations, and a crisis plan to meet P1’s care needs. P1’s Home Health Certification and Plan of Care (POC) dated 1/21/23, indicated P1 diagnoses included schizoaffective disorder (a combination of schizophrenia and mood disorders), major depression disorder, bipolar disorder, anxiety disorder, pain, unspecific psychosis, post-traumatic stress disorder, chronic systolic stress disorder, obesity, and type II diabetes. R1’s frequency of visits was skilled nursing visits every other week and one as needed (PRN) visit for changes in medical condition. R1’s orders of discipline and treatments. Upon interview on 3/23/23, at 10:55 a.m. P1’s psychologist stated she had not any communication with the agency since she had been working with P1 for 16 months. P1 stated she was aware that the agency set-up meds, but uncertain as to what else they provide. She sated she has never been updated about increased symptoms of concerns when P1 has had a crisis. Upon interview on 3/23/23, at 5:12 p.m. P1’s psychiatrist stated she has expectations of what an agency should be assessing. The psychiatrist stated she would be sending an e-mail to the surveyor of her expectations. On 3/10/23, the clinic reached out to the HHA requesting a medication list for care involvement, however none was received. “I would like to know what the agency does during the visits and how can they handle all of co-morbidities once every other week?” An email from the psychiatrist dated 3/24/23, at 12:21 indicated expectations as follows: Under the heading Psychiatric Symptoms: Behavior, Mood/Affect, Speech, Thought Processes, Social Judgement, Appearance, Suicide Risk, Hallucinations, Paranoia, Delusions, tardive dyskinesia. Also, hours of sleep, quality of sleep, exercise, and smoking. Under the heading Medical Symptoms: Infections, Gastrointestinal, (Bowel Assessment), Salivation, Cardiovascular/pulmonary (vital signs, cough, shortness of breath), under the heading Screens: Nutrition, Domestic Abuse Assessment, Fall Risk Assessment. A visit summary indicating any concerns, medication compliance, laboratory compliance, future visits/appointments. Measurable treatment goals listed, and progress of goals made along with education. The visit should include if the provider was contacted, and any refills needed. Upon interview on 3/23/23, at 3:16 p.m. RN-A, clinical supervisor stated he had not had any contact with P1’s psychiatrist or psychologist. P1 was uncertain whether other staff had reached out to them since they do not sign P1’s orders. Upon interview on 3/23/23, at 3:53 p.m. RN-F denied any agency contact with P1’s interdisciplinary team. An agency policy regarding notifying of providers or interdisciplinary team was requested, none was received.

On 8/18/22 to 8/19/22, a complaint survey was conducted. This resulted in a standard, survey at Adara Home Health Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. H80563992C/71502 was unsubstantiated, however related deficiencies were issued at G716, as a result of the complaint investigation.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and document review, the facility failed to ensure clinical notes were prepared to reflect care given during patient visits for 1 of 3 patients (P1) whose records were reviewed. P1's plan of care (POC) for the recertification period of 6/28/22 through 8/26/22, revealed diagnoses of unspecified cirrhosis of liver, thrombocytopenia, decreased white blood cell count, and psoriasis. In addition, the POC indicated P1 had skilled nursing services (SN) effective 7/10/22, once every four weeks and a skilled nurse was to obtain blood specimen via venipuncture 7/14/22 and 8/10/22. During review of Visit Note Report dated 8/11/22, it was revealed registered nurse (RN)-A documented the following "Unable to draw client's blood due to non-distended veins. Nurse unable to get blood draw today as [patient] PT is difficult to find vein." The note did not indicate how many times RN-A had attempted to do a venipuncture and how P1 had tolerated the procedure and what interventions were completed to enable the blood draw to be completed as ordered. During an interview on 8/19/22, at 9:06 a.m. family member (FM)-A stated, she was present during the skilled nursing visit on 8/11/22, when RN-A had gone to draw the blood for labs but was not successful. FM-A stated during the observation, she observed RN-A attempt to do the venipuncture several times not sure of how many and during the procedure, FM-A stated RN-A had left the building and gone back to the car to get additional needles to use. FM-A stated she had concerns of P1 bleeding out related to repeated venipuncture and had asked P1 how hospital staff were able to start get his veins and P1 had stated they would use a scanner to find the veins. During interview on 8/18/22, at 1:36 p.m. RN-A stated she had attempted to draw monthly labs on P1, and she was not able to do because P1's skin was not easy. RN-A stated she had inserted the butterfly needle in P1's arm, had gotten a flush of blood using the butterfly needle but was not able to get the blood and she had cued P1 she was going to pull the needle out and had applied pressure in the area using gauze. RN-A then stated P1 had informed her he was difficult patient to get a vein to get the blood draw. RN-A stated she had on a previous visit had been able to complete the blood draw with her preceptor and thought she was going to be able to do it at this visit also. RN-A then stated she thought she had attempted the blood draw two to three times and then she had called her supervisor who had instructed her to ask P1 to go in to have it completed at the primary physician clinic or the agency was going to send another nurse the next day to do it. RN-A stated during the procedure FM-A was present and each time she tried to do the venipuncture, FM-A would turn around and never asked her to stop attempting the blood draw. RN-A acknowledged each time she had pulled the needle off P1's skin, P1 would have a few drops of blood but was able to stop the bleeding with applying pressure in the area. RN-A stated after she stopped all the attempts before she left the facility, she stayed to make sure P1 did not have any bleeding. RN-A stated she had called the primary physician office and left a voice message about not being able to do the blood draw that day. RN-A acknowledged she had not documented the chain of events during the visit. RN-A stated she was supposed to document everything including communication to the physician. RN-A stated the next day also her supervisor did send a message to the primary to inform them the blood draw was not successful and that due to staffing the blood draw was going to be completed the next week. During a follow interview on 8/18/22, at 4:16 p.m., RN-A stated during the attempts she had asked P1 if he was experiencing pain, and P1 did not tell her he was in pain in any of the hands and after each failed attempt P1 kept asking her to "do it." RN-A stated also during the procedure as she attempted FM-A was talking to P1 and her directly and FM-A did not ask her to stop attempting the procedure. RN-A acknowledged she had gone to her car a couple times because first she had realized she had forgotten to bring in the appropriate form to fill out for the blood draw and then the second time she had gone to her car to get another butterfly needle because she had used the two needles in the kit. During an interview on 8/18/22, at 3:18 p.m. the RN manager stated she would have expected all staff to at least attempt to do two pokes any blood draw and the nurses were supposed to do the procedure to include what was being done, how many attempts had been completed, how the patient tolerated the procedure and when and if the physician was notified this all was also supposed to be documented in the medical record. The agency Clinical Practice Foundations policy revised 6/2/21, directed staff: "11. Document all client/caregiver interactions, including communications, procedures, instructions, and response in the clinical record. Unusual occurrence/client complaints are documented and kept separate from the clinical record..." The agency Venipuncture policy revised August 2021, directed nurses to "document the patient's tolerance of the procedure, any adverse reactions that occurred, the name of the practitioner notified, the date and time of notification..."

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 4/18/22-4/21/22 during a recertification survey. The facility is in compliance with the Appendix Z Emergency Preparedness Requirements.

On 4/18/22-4/21/22 a recertification and complaint survey was conducted. This resulted in a partial extended survey at Adara Home Health Inc. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. An IDR was completed on 11/30/22 as a result of this survey. The facility was challenging G0940, G0972 and G0974. As a result, the condition level tag at G0940 will be removed and the standard level tags at G0972 and G0974 will also be removed. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Unduplicated census previous 12 months: 4488 Total home visits conducted: 7 Location visited: Parent office location: Buffalo-25 1st Ave. NE, Suite 100 Buffalo, MN 55313 Branches Visited Blaine-10141 University Ave. NE, Suite 300 Blaine, MN 55434 Mankato-1961 Premier Dr., Suite 340 Mankato, MN 56001 Granite Falls- 761 Prentice St, Suite 3 Granite Falls, MN 56241 Other locations visited: Mendota Heights- Pending branch application approval 1333 Northland Drive Suite 225, Mendota Heights, 55120 Branch not visited: Hutchinson- 246 Main St. S Hutchinson, MN 55350 RECORDS REVIEWED FROM REMAINING BRANCHES: St. Jospeph-710 County Rd 75, Suite 104 St. Joseph, MN 56374 Rochester-230 20th Ave. SW, Suite 101 Rochester, MN 55902 Hours of Operation: 8:00 a.m.- 5:00 p.m. Total number of records reviewed: 18 The following complaints were found to be unsubstantiated: H8056076C/62701 H8056077C/61680

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency failed to complete a comprehensive drug regimen review to ensure the accuracy of all medications/dosage for 2 of 7 patients, (P7) and P(8) whose medications were reviewed during home visit and record review. P7’s plan of care (POC) indicated start of care (SOC) of 2/9/22. The POC for certification date of 4/10/22 to 6/8/22 included diagnoses of hypertensive heart disease with heart failure, acute on chronic systolic (congestive) heart failure, atherosclerotic heart disease, constipation, osteoarthritis, anemia, long term use of anticoagulants, and history of falling. The POC indicated skilled nursing (SN) one visit per week for two weeks. SN was to provide overall assessment, medication review and teaching. P7’s POC included the following medications: amiodarone 200 milligrams (mg) by mouth (po) daily (qd); Apixaban 5 mg po twice per day (BID); atorvastatin 40 mg po every bedtime (q hs); caltrate 600 + D oral tablet, two tablets po BID; dutasteride 0.5 mg po qd; furosemide 20 mg po qd, mirtazapine 15 mg po q hs; multivitamin one tablet po qd; nitroglycerin 0.4 mg po every (q) 5 minutes as needed (prn) for chest pain; and senekot s 50 mg-8.6 mg one tablet po bid prn. During home visit on 4/19/22, at 10:00 a.m. P7’s medications were reviewed with assistance from his spouse. P7 indicated the apixaban had been discontinued early February due to his history of falling. P7 also indicated the furosemide had been decreased to 20 mg q 3rd day. P7 stated the changes were made by his cardiologist. P7 reported to registered nurse (RN)-B that he had been taking Tylenol Arthritis, two tablets po q am, one tablet at noon and two tablets at hs, since the middle of March when he had fallen at his physician appointment. Upon review of P7’s clinical record, skilled nursing was discontinued on 2/17/22. Physical therapy (PT) and occupational therapy (OT) continued. Review of PT note dated 3/23/22, revealed P8 was taking Tylenol to manage his back pain. The PT did not update the medication regimen. OT discontinued visits with P7 on 4/5/22 and PT discontinued visits on 4/6/22. Upon review of P7’s clinical record, RN-B completed at skilled nurse visit on 4/8/22 for recertification of his plan of care. RN-B documented comprehensive drug regimen review completed and no changes to medications. During interview with RN-B on 4/19/22, at 2:00 p.m. she indicated she was not aware of the medication changes. She stated she updated P7’s medication profile to indicate the addition of Tylenol after the 4/19/22 visit. RN-B stated she checked with clients at every visit for new or changed medications. RN-B confirmed that she completed the recertification assessment on 4/8/22. During interview with Blaine clinical manager (CM)-D on 4/20/22, at 11:50 a.m. she stated therapists could also update medication regimens and could also reach out to a nurse if the change warranted nursing involvement. P8’s plan of care (POC) indicated start of care (SOC) date of 2/12/22. The POC for certification date 4/13/22 to 6/11/22 included diagnoses of chronic obstructive pulmonary disease (COPD), hypertensive heart and chronic kidney disease with heart failure, acute in chronic combined systolic and diastolic congestive heart failure, type 2 diabetes mellitus with diabetic chronic kidney disease, and chronic kidney disease, anemia, Vitamin D deficiency, and morbid obesity. The POC indicated occupational therapy (OT) one visit as needed (prn) for three weeks and OT one visit per week for four weeks, physical therapy (PT) one visit prn and PT one visit per week for three weeks, skilled nurse (SN) three visits prn for 10 weeks and SN two visits per week for 10 weeks, and home health aide (HHA) one to three hours per week for 10 weeks. P8’s POC included the following medication: Aquaphor Healing 41% white petroleum, apply topically to BLE twice per day (BID) am and pm; atorvastatin 40 milligrams (mg) by mouth (po) every (q) bedtime (hs); bumetanide 2 mg po BID am and pm; clopidogrel 75 mg po q am; ferrous sulfate 325 mg po q am; fluticasone spray, suspension, 50 micrograms (mcg)/actuation, two sprays each nostril each morning; lactobacillis rhamnosus one capsule po BID; levothyroxine 50 mcg q Sun, Tues, Thurs, Sat in am, and 75 mcg po q Mon, Wed and Fri in am; losartan 50 mg po q am; magnesium oxide 200 mg po q am; metoprolol tartrate 25 mg po BID; montelukast 10 mg po q pm, nystatin 100,000 units/gram, apply to skin folds and groin to affected areas BID’ potassium chloride 20 milliequivalents (mEq) extended release po BID; and warfarin 2.5 mg po on Mon, wed, Thurs, Fri and Sat q pm. During a home visit on 4/20/22, at 1:20 p.m. P8 stated she handled her own medications and had a system to take them. P8’s current medications in her home were compared to the POC dated 4/13/22 to 6/11/22. Medications P8 indicated she was taking that were not included on the POC included: Advair 250/50 inhaler, two puffs po BID, Vitamin D2 50,000 units one po Sun and Wed, and also Balmex (zinc oxide cream), topically to open or irritated areas as needed. P8 stated she had been taking the medications for at least a year. During interview with Blaine clinical manager (CM)-D on 4/20/22, at 11:50 a.m. stated the clinicians complete a medication review at every visit and update in the software system. The software then was able to run the drug to drug interaction report and notify the provider of any major interactions. During interview with registered nurse (RN)- A on 4/21/22 at 8:45 a.m. she stated she could have missed the medications at the SOC, stated she wasn’t sure what happened. RN-A stated medication reviews were completed at every visit. During interview with Blaine general manager (GM)-B on 4/20/22 at 4:20 p.m. stated she expected all clinicians to perform a medication review at every visit. Review of the agency’s policy, Medication Management, reviewed 4/6/21, indicated it was the responsibility of the healthcare professional to complete a comprehensive drug regimen review of prescribed medications, over-the-counter medications and herbal supplements for each client. Further, the review was to be completed at a minimum at the following time points: initial assessment/SOC visit, resumption of care, when there is a new medication, and following a significant change in the client’s condition.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on interview and document review, the agency failed to ensure the physician orders were followed for 1 of 18 patients (P7), who had home health aide ordered, but the service had not been provided, and the physician had not been notified the service was not provided. P7’s plan of care (POC) indicated start of care (SOC) of 2/9/22. The POC for certification date of 2/9/22 to 4/9/22 included diagnoses of hypertensive heart disease with heart failure, acute on chronic systolic (congestive) heart failure, atherosclerotic heart disease, constipation, osteoarthritis, anemia, long term use of anticoagulants, and history of falling. The POC indicated skilled nursing (SN) one visit per week for three weeks to provide overall assessment, medication review and teaching; occupational therapy (OT) and physical therapy (PT) one visit each as needed (PRN) for an evaluation; and home health aide (HHA) one visit per week for four weeks for shower assistance. Review of P7’s clinical record revealed that the agency did not provide the HHA visits. The agency failed to notify the physician of the HHA visits not provided to P7. During interview on 4/19/22, at 9:15 a.m. Mendota Heights (MH) general manager (GM)-D stated she could not locate HHA visits or verbal orders regarding HHA in P7's clinical record. Further, at 9:45 a.m., MH GM-D stated P7 and spouse declined HHA services and the agency overlooked sending a verbal order to the MD, it was an error. Review of policy, Missed Visits, Process No: O-11-053, undated, indicated the physician must be notified of the missed visit within 10 business days.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to obtain physician orders to provide skilled nursing (SN), for 1 of 18 patients (P7), reviewed for home care services. P7’s plan of care (POC) indicated start of care (SOC) of 2/9/22. The POC for certification date of 2/9/22 to 4/9/22 included diagnoses of hypertensive heart disease with heart failure, acute on chronic systolic (congestive) heart failure, atherosclerotic heart disease, constipation, osteoarthritis, anemia, long term use of anticoagulants, and history of falling. The POC indicated skilled nursing (SN) one visit per week for three weeks to provide overall assessment, medication review and teaching; occupational therapy (OT) and physical therapy (PT) one visit each as needed (PRN) for an evaluation; and home health aide (HHA) one visit per week for four weeks for shower assistance. Review of P7’s physician’s orders revealed a supplemental order dated 2/17/22 that indicated client was stable, discharge from SN, continue with home therapy. Verbal order dated 4/5/22 indicated discharge of OT. Verbal order dated 4/6/22 indicated discharge of PT. P7 had complained of shortness of breath at PT's discharge visit, PT recommended transfer to emergency room. Registered nurse (RN)-B completed an SN visit on 4/8/22 to complete a comprehensive assessment and recertify P7 for orders dated 4/10/22 to 6/8/22. Review of P7's discharge orders from emergency room visit on 4/6/22 indicated discharge to home or self care. The medical record lacked orders for nursing services. The POC dated 4/10/22 to 6/8/22, electronically signed by RN- on 4/8/22, indicated SN one visit per week for two weeks. The POC had not yet been signed and returned to the agency at time of survey. Further, P7 did not receive an SN visit the week of 4/11/22, as P7 spouse stated she had cancelled the visit related to P7 going to the emergency room again. The medical record lacked any communication related to missed visit. During interview on 4/19/22, at 2:00 p.m. RN-B indicated she had not obtained a physician order for nursing services prior to 4/8/22. During interview on 4/19/22, at 3:55pm MH GM-D indicated RN-B saw P7 on 4/8/22 to complete a significant change in condition, but had no orders to do so. Agency policy, Physician/Non-Physician Practitioner Orders, revised 7/20/21, indicated there must be a current written or electronically recorded order or prescription for all client treatments and therapies, including all prescribed medications that the company is managing for the client. All physician/NPP orders will be reduced to writing at the time they are received, signed and dated and sent to the physician/NPP for signature.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on observation, interview and document review the home health agency (HHA) failed to ensure screening for COVID-19 signs and symptoms was completed prior to the start of a visit for 1 of 7 patients (P4) observed during home visits. P4's start of care (SOC) was 12/8/2020. P4’s plan of care (POC) for certification period 3/13/22 to 5/11/22, indicated he received home health aid visits for one to three hours each week. P4 received physical assist with bathing and dressing from agency staff. P4’s diagnoses included heart failure and congestive heart failure. P4’s Care Coordination Note, print date 4/21/22, indicated P4 received the initial two doses of a COVID vaccination, but had not received a booster dose. On 4/19/22, at 1:40 p.m. home care aide (HCA)-A entered P4’s home, asked how P4 was, but failed to ask specific questions related to COVID-19 signs and symptoms. HCA-A proceeded to gather supplies, preparing to assist P4 with his shower. HCA-A assisted P4 to the bathroom to undress and into the shower. HCA-A assisted P4 with bathing and rinsing task followed by drying, applying lotion and dressing. P4 was not observed to have COVID-19 signs and symptoms. On 4/19/22, at 2:15 p.m. HCA-A confirmed she did not call P4 prior to arriving to his home to screen him for COVID-19 signs and symptoms and did not ask specific questions when she entered his home. HCA-A stated she worked with P4 each week and was not concerned his health would change enough to screen him with each visit and P4’s spouse will usually alert HCA-A if P4 is not feeling well. HCA-A stated she was aware she needed to screen all patients before her visits and did this with other patients. HCA-A was not aware of P4’s vaccination status. On 4/20/22, at 2:30 p.m. clinical manager (CM)-F stated she expected staff to screen patients at the patient’s door for COVID-19 signs and symptoms, before fully entering the home. CM-F stated all disciplines visiting the patient needed to complete the screening with each visit. The risks of not screening included the not identifying potential health concern prior to providing care. CM-F stated, “not screening is not acceptable.” Agency policy, Client Screening Process for COVID-19 dated 2/22, instructed COVID-19 screen on arrival to home was done before entering the home, while maintaining a distance of at least six feet.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: The Condition of Participation: Organization and administration of services 42 CFR 484.105 at G940, was found not met. The parent home health agency (HHA) failed to provide support and administrative control of its branches. Administrative and supervisory functions were being provided by a corporate division out side of the parent location. This had the potential to affect all six approved branch and one pending branch of the HHA’s branches and all patients who received services from the HHA branches. See G972 for additional information. Based on observation, interview and document review, the home health agency (HHA) failed to to obtain branch status approval at the Mendota Heights branch which was determined to be fully operational from this location at the time of survey. This had the potential to affect all patients who received services from the HHA branches See G974 for additional information. Based on interview and record review, the parent home health agency (HHA) failed to ensure support and administrative control was being provided by parent location. The supervision and administrative control was done by the cooperate division outside of the parent location. This had the potential to affect all six approved branches and one pending branch of the HHA branches and all patients who received services from the HHA branches.

Report all branch locations to SA CFR(s): 484.105(d)(1) The parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA's request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the home health agency (HHA) failed to to obtain branch status approval at the Mendota Heights branch which was determined to be fully operational from this location at the time of survey. This had the potential to affect all patients who received services from the HHA branches During interview with Mendota Heights (MH) general manager (GM)-D on 4/18/22, at 10:50 a.m. she confirmed the MH office had 87 employees and client census of 184. During interview with MH GM-D on 4/18/22, at 1:00 p.m. she indicated Adara office located in MH included a general manager, clinical manager, staffing manager, administrative assistant, document reviewer, and would have a business manager shortly. MH GM-D stated MH office had staff strictly assigned to the office and also had shared employees from other branches. She confirmed that she or the staffing manager perform job interviews at this location. During interview with MH GM-D on 4/19/22, at 3:00 p.m. she indicated the corporate office submits their OASIS data because the MH office does not have a federal ID. She stated the CEO was working on getting branch approved. Further, she stated when they do become approved, it would change the advertising, OASIS submissions and they would have a dedicated intake line. She indicated MH office did take referrals, but they came in through the MH office main phone line. Surveyor informed GM-D that a patient information handbook was observed during home visit on 4/19/22, at 10:00 a.m that listed MH as a branch office. GM-D stated she must have forgotten about that. Upon review of organizational chart for the Mendota Heights (MH) office dated 5/6/21, it indicated general manager (GM)-D, along with clinical manager, staffing manager, administrative assistant, business manager, intake coordinator, customer relations manager, clinical quality specialist, RN and PT managers, and field staff, among many others, assigned to MH office. Upon review of employee list dated 4/4/22, surveyor confirmed 87 employees at MH office. Surveyor observed various MH employees present at the office on 4/18/22 and 4/19/22. During home visit on 4/19/22, at 10:00 a.m. surveyor observed MH employee, RN-B, providing nursing services to P7. Surveyor also observed P7's patient information booklet from the agency. It listed MH as a branch office, included address and phone number.

Direct support and administrative control CFR(s): 484.105(d)(2) The parent HHA provides direct support and administrative control of its branches. This ELEMENT is not met as evidenced by: Based on interview and record review, the parent home health agency (HHA) failed to ensure support and administrative control was being provided by parent location. The supervision and administrative control was done by the cooperate division outside of the parent location. This had the potential to affect all six approved branches and one pending branch of the HHA branches and all patients who received services from the HHA branches. Following survey exit, on 4/25/22, an email communication from Adara Home Health Inc. agency was revived and identified the following: The parent consists of two Divisions: 1. Buffalo location– provides services to patients within the designated zip codes assigned to the Buffalo location 2. Corporate location- provides administrative services and supervisory/compliance functions for all locations (the parent Buffalo location and all branches), including sharing employees across parent/branch locations The corporate division of the parent is responsible for the following parent and all branches: -Administrative functions: payroll, client billing, electronic medical record, IT support, benefits administration, recruiting, all contract management (payer, subcontracts, etc.) for the parent and branches, etc. -Supervisory functions: onsite supervision at all locations, parent and branches, for clinical and regulatory compliance, establishment of clinical and regulatory policy, involvement in any issues and unusual occurrences company-wide in the provision of patient care and employee management, development and implementation of clinical/regulatory/human resources training company wide, sharing The email identified the following designated functions: Administrator: oversees the parent and all branches. Utilizes the teams below to effectively manage the company. Is available to all patients and employees to contact at any time, and is involved with concerns and issues at the parent and branches on a daily basis. During interview with General Manager (GM)-A on 4/18/22, at 11:20 a.m. in charge of Mankato branch stated that she reports to corporate (parent ) one to two times a week and as needed. GM-A indicated corporate has monthly meetings called round table with each department. GM-A reported the intake and referrals are completed through the branch office and will involve corporate if there are any concerns. GM-A further stated that the hiring process includes receiving the application from corporate and and each branch office staff will interview the applicant and then decide if the applicant is appropriate for hiring. GM-A indicated will reach out to corporate if they have any questions or concerns. GM-A reported that the corporate office does not have a service area itself however, they have the corporate office in buffalo and then a branch office. GM-A reported the corporate and branch office in Buffalo are in the same building. During interview with clinical manager (CM)-C on 4/18/22, at 1:20 p.m. for Mankato branch stated that the parent branch are available if they are needed. CM-C further stated that the branch offices are in charge of referrals and intake process. CM-C stated with the hiring of staff the recruiter at the corporate level will send the applicant to the branch to where the staff would work to interview with the mangers and then they would make the decision to hiring if applicable. CM-C stated they have monthly meetings per discipline called a round table they also do IDT meetings weekly. CM-C further stated the parent are made aware of any unusual incidents that would occur. During interview with GM-C on 4/20/22, at 9:45 a.m. stated being in charge of the Granite Falls branch office and then oversees the clinical managers and the day-to-day items. She reports directly to corporate and is involved with weekly and monthly meetings. GM-C reported corporate is always there if they are needed and feels very supported. GM-C reported intake and referrals are handled within each branch and would involve corporate if needed. The hiring process is the same. If they had any concerns with payor source they would reach out to corporate. During interview with CM-A on 4/20/22, at 9:56 a.m. for Granite Falls branch stated they communicate with the parent branch daily. If there were any unusual occurrences, they would involve corporate after reviewing incident. CM-A further stated all applicants come from the corporate office for the branch to interview and hire. CM-A stated intake and referrals are completed at each branch office. The parent branch is not involved with the referrals or case intake. On 4/19/22, at 2:30 p.m. branch manager (BM)-E stated she oversees all operations of the Buffalo branch office only. BM-E has no administrative control of the other branch offices, the corporate office manages that control. Referrals for intakes and new employees are managed by the branch office. The corporate office manages policies and assists with patient complaints and concerns regarding current employees. BM-E stated, need for additional staff was discussed with the corporate office, but the final decision to hire, for the Buffalo branch office was hers. On 4/19/22 at 3:50 p.m. the Director of Operations stated she was an employee of the corporate office. She confirmed the corporate office was considered the parent location, not the Buffalo branch. It was her responsibility to provide parent oversite to all branch locations. Director of Operations stated she was not involved in the referral or intake process. The intake department, in the corporate office, reviewed the intake and communicated directly with the appropriate branch manager. She was made aware of current client concerns and complaints, but was not directly involved in resolving these. She was not involved in the new hire process. She worked with the general managers of each branch office to ensure staffing was adequate to meet the needs of existing and possible new patients. On 4/21/22, at 10:20 a.m. the Director of Clinical Operations stated she was an employee of the corporate office. She stated, all offices, included the Buffalo offices were limited in what patient information they have access to. Each branch office was able to access patient information for their own branch, but no branch office was able to access all patient information. Only staff who were assigned to the corporate office were able to access all patient information.