Every finding on record at Ecumen

A survey with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 7/8/25, through 7/10/25, during a recertification survey. The facility WAS in compliance with the Appendix Z Emergency Preparedness Requirements.

On 7/8/25 through 7/10/25, a recertification survey was conducted. This resulted in a standard survey at Ecumen Home Care. 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: 454 Total home visits conducted: 04 List Parent Location visited, including the addresses as verified while on site Ecumen Home Care Lakeshore 4000 London Road Duluth MN 55804 List all other branch offices for this agency and identify which of these were visited during this survey and which you pulled records from No Branches List Hours of Operation: 8:00 a.m. to 4:30 p.m. List total number of records reviewed: 10

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on interview and document review the facility failed to give the Notice of Medicare Non-Coverage (CMS 10123-NOMNC) at least 48 hours prior to discharge from services. This had the ability to effect 1 of 3 (P8) patients reviewed for discharge process. Findings include: P8's plan of care (POC) dated 2/7/25 to 4/7/25 indicated P8 received physical therapy and occupational therapy services. P8's Discharge Order dated 3/4/25 at 2:35 p.m., indicated P8 was discharged on 3/4/25, from home health agency services. P8's CMS 10123-NOMNC dated 3/4/25 indicated last day of Medicare coverage was 3/4/25. During an interview on 7/10/25 at 1:08 p.m. the registered nurse clinical director (RNCD) stated all skilled patients would receive the CMS 10123-NOMNC at least 48hrs prior to discharge from services. P8's chart was reviewed and the RNCD acknowledged P8 received the CMS 10123-NOMNC the same day of discharge from services. Facility Policy Expedited Determination Policy undated, each Medicare beneficiary would be notified in writing using the CMS 10123 no later than two days before covered home care services would end.

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 facility failed to setup medications as ordered by the provider. This affected 1 of 1 (P5) patient reviewed for medication setup. R5's plan of care (POC) dated 5/18/25 to 7/16/25, indicated P5 received Cholecalciferol (Vitamin D3) 400 international units (IU) two times a day (BID) by mouth. During an observation on 7/9/25 at 1:18 p.m., licensed practical nurse (LPN)-A set up Vitamin D3 one time a day for the two weeks' worth of medications R5 would take. During an interview on 7/9/25 at 2:08 p.m., LPN-A stated there had been confusion on if P5 should take one table one time a day or BID. The current order in the POC was to give one BID. P5 would sometimes take 1 capsule and other times take 2 capsules. It just depended on what he wanted to take. The staff are pretty sure it should be one capsule once a day, so I have just been setting up a once-a-day dose of Vitamin D3 for P5. During an interview on 7/10/25 at 1:07 p.m., the registered nurse clinical director (RNCD) stated the medication orders on the POC were the correct orders. When the meds are set up, they should be set up according to the POC. IF there is a question related to the ordered medications the nurse should request clarification from the provider but follow the current order until the clarification is received and changed on the active orders. Facility policy Medication Administration undated, indicated medications and treatments would only be administered or set up only as ordered by the provider.

A survey with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 4/17/23, through 4/19/23 during a recertification survey. The facility is WAS in compliance with the Appendix Z Emergency Preparedness Requirements.

On 4/17/23 through 4/19/23, a recertification survey was conducted. This resulted in a partial extended survey at Ecumen Home Care. 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: 412 Total home visits conducted: 04 List Parent Location visited, including the addresses as verified while on site Ecumen Home Care Lakeshore 4000 London Road Duluth MN 55804 List all other branch offices for this agency and identify which of these were visited during this survey and which you pulled records from No Branches List Hours of Operation: 8:00 a.m. to 4:30 p.m. List total number of records reviewed: 10

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure each patient had an initial assessment visit within 48 hours of the referral date for 5 of 10 patients (P1, P2, P4, P5, P6) reviewed in the sample. P2's plan of care (POC), dated 2/18/23 to 4/18/23, indicated P2's start of care (SOC) was 12/20/22. Diagnoses included stage two pressure ulcer left and right heel, parkinson's disease and neurocognitive disorder with lewy bodies. The POC further indicated P2 required skilled nurse visits (SNV) for dressing changes physical therapy (PT) and occupational therapy (PT). SNV were ordered three times a week for nine weeks, PT three times a week for four weeks and OT two times a week for three weeks. P2's referral order fax stamped 12/6/22, indicated a home care evaluation for Occupational and Physical therapy evaluation. The referral order also indicated P2 was discharged from the skilled nursing facility on 12/9/22 The clinical record failed to identify any reason why P2 had not been assessed within 48 hours of the discharge date of 12/9/22,and lacked evidence P2's physician was notified of the delay in the SOC date. P6s POC dated 4/2/23 to 5/31/23, indicated P6's SOC was 2/1/23. Diagnoses included sepsis, klebsiella pnuemonia and hypertensive kidney disease. SNV was ordered for PICC line catheter dressing change weekly. SNV were scheduled 1 time a week for 9 weeks. P6's referral with dated of 1/29/23, indicated SNV for IV antibiotic and PICC line management. The clinical record lacked evidence P5's physician was notified of the delay in the SOC date or an order written to delay admit. When interviewed on 4/18/23 at 1:46 p.m., centralized intake specialist (CIS) stated referrals came through the referral center, was scheduled within 48 hours of arrival and sent to the branch facility. When interviewed on 4/18/23, at 9:47 a.m. the director of nursing (DON) stated it was the agency's policy to admit patients within 48 hours of receiving their referral. If the admission cannot occur within 48 hrs of referral we would notify the referral source such as the hospital. We do not get an order to delay the admission past 48 hrs. Home Care policy Initial Assessments/Comprehensive Assessments dated 2/21, indicated if the agency could not complete the admission assessment with 48 hours of referral the medical provider would be notified of the delay of care and the facility would obtain a verbal or written order so the medical provider could acknowledge and accept the safe plan. P1's plan of care (POC) 9/29/22 through 11/27/22, indicated a start of care date (SOC) 9/29/22. Diagnoses included heart disease, macular degeneration, depression and spinal stenosis. P1 required skilled nurse visits (SNV) one visit every other week for nine weeks for various assessments and evaluation and, occupational therapy visits (OT) to evaluate for home safety. A physical therapy (PT) had been requested. A referral order with fax stamped received on 9/19/22, indicated the physician requested services for skilled home care, OT to evaluate and treat. The referral indicated the request was called to the agency, and the agency had accepted the referral to provide the therapy services. P1's clinical record failed to identify any reason P1 had not been assessed within 48 hours of the referral date 9/19/22, and lacked evidence P1's physician was notified of the delay in the SOC date. P4's POC 3/28/23 through 5/26/23, indicated a SOC date 3/28/23. Diagnoses included malignant neoplasm of lung, heart disease, heart failure, diabetes and post traumatic stress disorder. P4 required SNV every week for nine weeks for various assessments and evaluation of condition as well as medication management, home health aide (HHA) every week for eight weeks for assist with bathing, dress, and grooming. OT was ordered one time per week for one week then two times per week for three weeks to train with activities of daily living, adaptive equipment. PT was ordered two times per week for three weeks for therapeutic exercises and gait training. P4's discharge summary indicated P4 was discharged to his home on 3/24/23, with orders for in home PT, OT, SNV, and HHA visits. P4's clinical record failed to identify any reason P4 had not been assessed within 48 hours of the referral date 3/24/23, and lacked evidence P4's physician was notified of the delay in the SOC date. P5's POC 3/23/23 through 5/21/23, identified a SOC date 3/23/23. Diagnoses included fracture of right clavicle, atrial fibrillation (irregular heartbeat), depression, adjustment disorder, pacemaker and long term use of anticoagulants (blood thinner medication). P4 required a SNV for the SOC assessment, OT three times per week for four weeks to train with ADL and therapeutic exercises and PT one time per week for one week, then two times per week for four weeks for gait and balance training, fall prevention, positioning and exercises. P5's faxed referral was dated 3/9/23, with orders to start PT for range of motion and strengthening. P5's clinical record failed to identify any reason P5 had not been assessed within 48 hours of the referral date 3/9/23, and lacked evidence P5's physician was notified of the delay in the SOC date. During interview on 4/19/23, at 11:45 a.m. the director of nursing (DON) stated referrals were routed to the agency's centralized intake. They entered the referral into the agency's system and added the SOC to the agency's calendar. The clinical manager or DON assigned them to staff from that point. It was the agency's practice to obtain a supplemental order from the physician for a delayed SOC date if the assessment could not be completed within the 48 hour time frame after receiving the referral.

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: P6's plan of care (POC) dated 4/2/23 to 5/31/23 included diagnoses of sepsis, hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease and postsurgical malabsorption. The POC also included medication Lasix 20 milligrams (mg) orally once a day. When interviewed on 4/18/23 at 11:45 a.m., P6 stated she had never taken Lasix and couldn't because of all of her issues with fluid malabsorption. When interviewed on 4/18/23 at 11:48 a.m., registered nurse (RN)-B stated medication reviews were performed on start of care and each recertification visit. RN-B stated she had just finished the current POC on 4/2/23 and had verbally gone over all of the medications with P6 but did not remember if P6 told her that she could not take the Lasix. She agreed Lasix would not be an appropriate medication for R6 due to her malabsorption concerns. When interviewed on 4/19/23 at 11:53 a.m., the director of nursing (DON) stated during medication review the nurses would look at the medication bottles and compare to the medication list. They would verify correct medication, correct dose and if the medication bottles were expired or not. If the patient is no longer taking the medication, then an order from the provider would be obtained to discontinue the medication. Facility policy Medication Management last revised 3/18, indicated medications in the home would be reviewed with the client to determine current medications prescribed.

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, that agency failed to ensure visits were conducted in accordance with physician orders for 4 of 10 patients (P1,P3,P4, P10) and failed to notify the physician when the visits were not conducted according to the plan of care (POC). P1's plan of care (POC) 9/29/22 through 11/27/22, indicated a start of care date (SOC) 9/29/22. Diagnoses included heart disease, macular degeneration, depression and spinal stenosis. P1 required skilled nurse visits (SNV) one visit every other week for nine weeks for various assessments and evaluation and, occupational therapy visits (OT) to evaluate for home safety. A physical therapy (PT) had been requested. P1's SNV from 1/01/23, through 4/19/23, indicated SNV were performed 1/19/23, 1/26/23, 2/2/23, 2/16/23, 3/16/23, 3/27/23, and 4/14/23. P1's documented visit schedule indicated he had refused nurse visits on 1/5/23, and 3/6/23. P1's medical record lacked evidence P1's physician had been notified of the missed SNV. P3's POC 1/25/23 through 3/25/23, indicated at SOC date 1/25/23. Diagnoses included attention to colostomy (artificial opening in the colon through the abdomen), hemiplegia, pulmonary fibrosis and chronic obstructive lung disease (COPD). P3 required SNV two times per week for 9 weeks plus four as needed (PRN) for various assessments, evaluation, monitoring anticoagulation treatment and colostomy care. OT was ordered tow times per week for three weeks, then one times per week for one week and two times per week for three weeks for training with activities of daily living (ADL), therapeutic exercises, pain management and fall prevention. Physical therapy (PT) was ordered tow times per week for six weeks, one time per week for one week and two times per week for three weeks for balance, gait training, home safety and transfer techniques. P3's visit schedule from 1/1/23 through 4/19/23, indicated P3 had missed OT visits on 2/2/23, 2/13/23, and 3/10/23. P3 had also missed PT visits on 2/3/23, 210/23, and 3/8/23. P3's medical record lacked evidence P3's physician had been notified of the missed visits. P4's POC 3/28/23 through 5/26/23, indicated a SOC date 3/28/23. Diagnoses included malignant neoplasm of lung, heart disease, heart failure, diabetes and post traumatic stress disorder. P4 required SNV every week for nine weeks for various assessments and evaluation of condition as well as medication management, home health aide (HHA) every week for eight weeks for assist with bathing, dress, and grooming. OT was ordered one time per week for one week then two times per week for three weeks to train with activities of daily living, adaptive equipment. PT was ordered two times per week for three weeks for therapeutic exercises and gait training. P4's visit schedule from 1/1/23 through 4/19/23, indicated P4 did not receive an HHA visit due to the agency did not have sufficient staff and the record did not indicate a HHA visit was scheduled on the schedule for the week of 4/10/23. P4's medical record lacked evidence P4's physician had been notified of the missed visits. P10's POC 1/27/23 through 3/27/23, indicated a SOC 1/27/23. Diagnoses included chronic ulcer left foot, kidney disease, COPD, peripheral vascular disease, heart disease, and open wounds left elbow and knee. Services included SNV one time every day for ten weeks for various assessments, evaluation, medication management, and monitoring for anticoagulant medication. OT was ordered one time per week for one week, then two times week for two weeks for ADL training, cognitive assessment, adaptive equipment, fall prevention and therapeutic exercises, PT was ordered one time per week for one week, then two times per week for four weeks for gait and balance training, fall prevention, lower body strength, and transfer techniques. A HHA was ordered one time per week for eight weeks to assist with bath, dress and grooming. P10's visit schedule from 1/1/23 through 4/19/23, indicated P10 had missed SNV on 2/9/23, and 2/28/23. P10 refused OT visits on 2/16/23 and HHA visits on 2/1/23 and 2/28/23. P10's medical record lacked evidence P10's physician had been notified of the missed visits. During interview on 4/19/23, the director of nursing (DON) indicated it was the agency's practice to notify physicians when patient visits were missed. The agency's undated policy Missed Visits indicated patient orders for treatments and services were the foundation of the plan of car. If the agency missed a visit or treatment or services as required by the plan of care which resulted in any potential for clinical impact the agency must notify the physician. If a patient refused care the agency must attempt to identify the reason and communicate with the physician on how to proceed with patient care.