Every finding on record at Lifespark Home Health

On 10/29/24 - 10/31/24 a complaint survey was conducted. This resulted in a partial extended survey at Lifesprk. 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: H81189961C Intake 110580 H81189962C Intake 110527 H81189963C Intake 109887 H81189964C Intake 109706 H81189965C Intake 108226 H81189966C Intake 106489

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 notify the provider when staff was unable to complete a service indicated on the plan of care for 1 of 3 patients (P1). P1’s care plan indicated the HHA would be completing skin assessments. Due to P1’s physical status the staff was unable to fully visualize P1’s skin during visits. A concern arose that P1 had pressure ulcers on her back and the HHA was unaware of the potential ulcers. Findings include: P1’s Home Health Certification and Plan of Care for certification period 10/2/24 – 11/30/24 indicated P1’s pertinent diagnoses were contusion (a blunt force injury) of the abdomen wall, chronic congestive heart failure, morbid obesity, chronic respiratory failure, and chronic pain. P1 received skilled nursing (SN) visits weekly for symptom management, physical therapy (PT) and occupation therapy (OT). P1’s order included skilled nurse to observe and assess integumentary (skin, hair, nails, and glands) status. SN to provide skilled teaching related to altered skin integrity including pathophysiology, nutrition, medication regimen. Skilled nurse to report significant changes in status to physician for early intervention. P1’s skilled nursing admission visit note indicated P1 did not have any pressure ulcers (damage to the skin from constant pressure on the area), stasis ulcers (a sound caused by abnormal or damaged veins), or surgical wounds. P1’s integumentary status was assessed, and bruising was noted. The note did not indicate the location of the bruising. P1’s skilled nursing visit note dated 10/9/24 indicated P1’s integumentary status was assessed and P1 had bruising. The note did not indicate what areas of skin were assessed or the location of the bruising. P1’s skilled nursing visit note dated 10/18/24 indicated P1’s integumentary status was assessed with no problems identified. P1’s skilled nursing visit note dated 10/20/24 indicated P1’s integumentary status was assessed with no problems identified. P1’s skilled nursing visit note dated 10/22/24 indicated P1’s integumentary status was assessed with no problems identified. Upon interview on 10/29/24 at 12:01 p.m. a first responder, indicated his team had been to P1’s home multiple times to assist with transfers or falls. On 10/17/24 P1 called stating she had an emergency. Upon arrival the first responders found P1 in a hospital bed in her kitchen seated on multiple urine and feces soiled pads. He stated P1’s weight 400+ lbs. When the team transferred P1 he noticed “bed sores” on her lower back and buttocks region. He described the area as open skin sores with redness covered in feces. P1 was taken to the emergency department for a complaint of abdominal pain. Upon interview on 10/29/24 at 3:18 p.m. P1 stated she was not certain whether she had skin ulcers on her back or not as she cannot visualize them. She stated she was not certain what the HHA was doing for her skin. P1 was offered a home visit by the state evaluator however declined the visit. Upon interview on 10/30/24 at 10:48 a.m. physical therapist (PT)-a stated he saw P1 for an evaluation visit. He got P1 to sit on the side of bed with taxing effort on her part and maximum effort on his part. He stated she was seated on a soiled disposable pad. P1 had a patient care assistant (PCA) through a different agency with her and PT-A held P1 in a seated position and the PCA changed the soiled pad. PT-A stated he did not notice P1’s skin because he was not looking at her skin he was concerned with her mobility. He stated P1 was unable to reposition herself and unable to transfer safely with assistance of one staff member due to her weight and physical condition. Upon interview on 10/30/24 at 11:27 a.m. registered nurse (RN)-B stated she was told by P1 that she had gone to the emergency department on 10/17/24 and was released the same evening. P1 told RN-B that she was found covered in urine and feces because her irritable bowel syndrome (IBS) had acted up. RN-B stated she had not been able to assess P1’s skin because P1 is bedbound and immobile in bed except for use of her arms. P1 was unable to reposition herself even with the use her siderails. RN-B stated was unable to position P1 to fully assess all her skin. RN-B stated she was not certain if P1’s back and buttock had pressure ulcers. RN-B denied reporting her inability to assess P1’s skin to the provider. RN-B stated she had a plan to complete one of her skilled nursing visits along with PT so both could attempt to position P1 audit her skin, but P1 cancelled the PT visit. Upon interview on 10/30/24 at 1:36 p.m. RN-C stated when she assessed P1, P1 was unable to “even roll herself from side-to-side”, therefore she was unable to view the skin of her backside. She did not report to the provider that she was unable to compete the skin assessment. In addition, RN-C stated the HHA “probably” should have reported P1 as a vulnerable adult. Upon interview on 10/31/24 at 10:00 a.m. P1’s providers nurse, RN-D stated the clinic did not receive any phone calls, emails, or fax documents with concerns for P1’s skin. She stated the only information received was P1’s recertification which indicated the HHA was assessing her integumentary status and a few notifications of delayed or missed visits. Upon interview on 10/31/24 at 1:12 p.m. the Administrator stated she was aware P1 had called emergency services often, but not aware the staff could not assess her skin fully. Her expectation was if staff cannot complete an order to notify the provider. An agency policy titled Monitory Patient’s Response/Reporting to Physician with a revision date of 2022 indicated the patient’s physician (or other authorized licensed independent practitioner) will be contacted on the same day when any of the following occur: F. When there is a problem implementing the plan of care.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to administer a treatment ordered by the physician for 1 of 3 patients (P3). P3’s provider placed an order with the HHA to measure and fit P3 for specialized leg wraps on 6/19/24. The agency did not order P3’s leg wraps until 9/18/24. Findings include: P3’s Providers order dated 6/19/24 indicated to please measure/fit patient for Farrow wrap 4000 or Sigvaris Compreflex wraps. Please ensure patient has wraps available to bring to his clinic appointment in one week for reapplication. P3’s Providers order dated 7/11/24 indicated to measure/fit patient for Farrow wrap 4000 or Sigvaris Compreflex and send to his next clinic appointment. Please ensure patient has wraps available to bring to clinic appointment for reapplication. P3's Home Health Certification and Plan of Care for certification periods 7/31/24 - 9/28/24 indicated P3's pertinent diagnoses were chronic venous insufficiency (improper functioning of the vein valves in the leg causing swelling and skin issues) and non-pressure ulcer of the right lower leg with fat layer exposed. P3 required skilled nursing (SN) weekly for wound complications. A telephone voicemail recorded message dated 9/17/24 at 10:36 a.m. between the provides licensed practical nurse (LPN)-A and the HHA registered nurse (RN)-A indicated LPN-A called the HHA and spoke to RN-A with concerns that P3 had orders for wraps faxed in July and August and concerned that he didn’t have them at his appointment on 9/13/24. RN-A clarified receiving the orders from July and August and stated she didn’t order the wraps because P3’s diagnosis wasn’t lymphedema therefore the HHA could not order the wraps. LPN-A verified the wraps were for chronic venous hypertension not lymphedema. RN-A stated she wasn’t sure if anyone from the HHA had ordered P3’s wraps and she would get back to LPN-A. LPN-A stated the provider would have ordered the wraps, but since P3 was on a skilled home care Medicare episode the HHA has to order all supplies per Medicare guidelines. A second telephone voicemail recording dated 9/17/24 with no time stamp indicated RN-A placed a call to LPN-A and stated the HHA measured P3 but did not order the Farrow wraps. She also stated she had spoken with the management team at the HHA, and the agency needed to discharge P3, but she would get the wraps sent to the HHA office and get the wraps to P3. A third telephone voicemail recording dated 9/19/24 with no time stamp indicated RN-A returned a call to LPN-A indicating the HHA discharged P3 and the HHA did have an extra visit and they would provide a visit to measure for P3’s wraps. P3’s occupational therapy visit note dated 9/18/24 indicated the therapist took P3’s measurements and educated P3 on the nature of the lymphedema and strategies for donning/doffing the wraps along with the wearing schedule. The HHA’s clinical manager ordered the wraps. The note did not indicate how or when P3 would receive the wraps. Upon interview on 10/29/24 at 11:54 a.m. P3’s provider stated he had been treating P3 for pressure ulcers and placed orders with the HHA two months in a row to order leg wraps for P3 and the order wasn’t completed. P3 was discharged from the agency on 9/13/24 as the agency indicated the wounds had healed and P3 came to the clinic 9/17/24 with no leg wraps and the ulcer had re-opened. The provided stated the unhealed ulcers were a chronic concern and P3 really needed the wraps. Upon interview on 10/30/24 at 8:31 a.m. P3 stated he did receive the wraps following his discharge from the HHA and was aware he should have had them sooner that than he received them. Upon interview on 10/30/24 at 11:45 a.m. RN-A stated she did review P3’s orders and saw the order from 6/19/24 and stated she didn’t think the HHA was responsible for ordering wraps. In addition, she stated Farrow wraps are for lymphedema and the agency was not treating him for lymphedema. RN-A spoke the HHA with management team, the wraps were ordered, and an occupational therapy visit was created to measure P3 on 9/18/24. RN-A was not certain if P3 had the wraps or not at the time of the state survey. Upon interview on 10/31/24 at 11:01 a.m. LPN-A stated P3’s wraps were originally ordered on 6/19/24 and the provider wanted P3 to have dressing changes twice a week, once by the HHA and once in the clinic. The HHA was to cleanse the wound, cover and place the wraps on P3 and then clinic would do the same. P3 saw the provider monthly and clinical staff weekly. LPN-A stated when P3 saw the provider on 8/26/24 he didn’t have the wraps, so the provider ordered them again. On P3’s provider appointment on 9/17/24 he still didn’t have the wraps, and P3 had been discharged from the HHA that was when LPN-A called the HHA for clarification. Upon interview on 10/31/24 at 1:12 p.m. the Administrator stated she was unaware of the order for wraps back in July and stated that when a client is on Medicare services the HHA is required to order the supplies. The Administrators expectations were staff follow all provider orders. A policy regarding provider orders was not obtained.

On 5/4/23 - 5/8/23 an abbreviated complaint survey was conducted. This resulted in a partial extended survey at Lifespark 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. Deficiencies were issued for complaint. H81181702C (MN97529) The Condition of Participation: Care planning, Coordination of services and Quality of care 42 CFR 484.60 at G0570 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 interview, and record review, the Home Health Agency (HHA) failed to follow physician orders by failing to complete an as needed skilled nursing visit for 1 of 1 patients (P1) reviewed for care planning and quality of care. This resulted in a condition of participation not met when registered nurse (RN)-A failed to complete a skilled nurse visit after being made aware P1 was having complication related to catheter care. P1 was hospitalized with sepsis secondary to acute pyelonephritis( a systemic inflammatory response to infection that can lead to multi-organ dysfunction), and a urinary tract infection secondary to Proteus and Enterococcus species. See tag G0572. Based on interview, and record review the Home Health Agency (HHA) failed to follow physician orders by failing to complete an as needed skilled nursing visit for 1 of 1 patients (P1) reviewed for care planning and quality of care. The HHA was notified that P1 had a temperature, mucus around the catheter and decreased drainage. Registered nurse (RN)-A failed to complete the visit or notify the agency that the visit was not completed. As a result, P1 was hospitalized with sepsis secondary to acute pyelonephritis( a systemic inflammatory response to infection that can lead to multi-organ dysfunction), and a urinary tract infection secondary to Proteus and Enterococcus species.

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 follow physician orders by failing to complete an as needed skilled nursing visit for 1 of 1 patients (P1) reviewed for care planning and quality of care. The HHA was notified that P1 had a temperature, mucus around the catheter and decreased drainage. Registered nurse (RN)-A failed to complete the visit or notify the agency that the visit was not completed. As a result, P1 was hospitalized with sepsis secondary to acute pyelonephritis( a systemic inflammatory response to infection that can lead to multi-organ dysfunction), and a urinary tract infection secondary to Proteus and Enterococcus species. The HHA emergency plan dated 12//9/21 indicated for urinary catheter and urinary infection problems to call the HHA nurse and a phone number was provided. The plan indicated to call if the catheter is leaking, blocked, or dislodged, urge to urinate frequently, in small amounts or unable to urinate, burning with urination, bloody, cloudy or change in urine color or foul odor, low back pain, and fever greater than 100.5 degrees Fahrenheit (F) or chills. P1’s Home Health Certification and Plan of Care (POC) dated 3/21/23 – 5/19/23 indicated P1 was receiving skilled nursing twice a week for one week, one time a week for eight weeks and two as needed (PRN) visits for wound or catheter complications or other acute care needs. Under the title Orders or Discipline and Treatments skilled nursing had orders to instruct P1 and/or caregiver on indwelling urinary catheter management including care of Foley catheter, signs and symptoms of complications, perineal care, tube, and bag placement. Skilled nurse had orders for insertion of the indwelling urinary catheter, maintenance with the catheter, change catheter every month and as needed for dislodgement or stoppage, and obtain urine specimen as indicated. P1’s Client Episode Coordination notes dated 4/13/23, indicated RN-B received a message to call P1’s assisted living facility (AL). RN-B documented a call was returned to the AL where a report of a fever overnight of 100.3 – 100.7 F. Extra Strength Tylenol has taken care of the fever, yellow mucous drainage around the catheter with very little output the previous night and nothing in the a.m. reported by AL licensed practical nurse (LPN)-A. P1's Client Episode Coordination note dated on 4/13/23, RN-A entered a missed visit notification. The note included the physician was notified; however, the documentation did not indicate how or when the physician was notified or any response from the physician. The note indicated the visit was missed because RN-A received “no answer.” The documentation did not identify RN-A was trying to notify the AL or the family. There were two questions left back on the coordination note. 1. Are there any adverse effects from missing this visit, if yes please explain? 2. Is this service still medically necessary please specify reason was also left blank. Upon interview on 5/4/23 at 2:45 p.m. P1’s family member (FM)-A stated that on 4/12/23, RN-B had changed P1’s catheter and there were no concerns. When FM-A visited on 4/13/23 she stated that P1’s catheter had mucous and wasn’t draining well, in addition P1 had a temperature of 101.3. FM-A stated she called the HHA three times without a response. FM-A asked the assisted living facility (ALF) to contact the HHA. The HHA received the call and responded back to the AL stating there would be a nurse visiting P1 on that same day of 4/13/23. FM-A waited at the facility with P1 until after 9:00 p.m. with no call or visit from any HHA nurse. On 4/14/23, FM-A called the agency again asking for a nurse to be sent out. FM-A stated there was no response from the agency. FM-A kept a record of P1’s temperatures from 4/14/23 – 4/17/23 where the range was 98.5 to 100.9. FM-A stated P1 had cloudy urine in his catheter and the mucus was still present. FM-A stated the phone number she continually called at the HHA was the number on the emergency plan sheet provided by the HHA. FM-A stated on 4/17/23 she reached out to the AL staff asking for assistance again to notify the HHA as she still wanted the catheter assessed due to P1’s status. The AL staff did not notify the agency. (LPN)-A, an AL nurse, reached out to the physician and was given orders to obtain a chest x-ray and a urinalysis. Before the orders were processed P1 became confused and upon transferring with a mechanical stand-up lift, P1 “collapsed.” The assisted living facility called 911 for emergency medical treatment. P1 was taken and admitted to the hospital with sepsis secondary to acute pyelonephritis, and a urinary tract infection secondary to Proteus and Enterococcus species. Upon interview on 5/5/23 at 8:15 a.m. RN-B stated she changed P1’s catheter on 4/12/23 she stated the catheter had “bypassing.” so she changed the catheter with no concerns. RN-B stated she was aware P1 had been assigned a PRN visit the day following her visit and was aware the visit hadn’t been completed. RN-B stated she did not receive clarification if the visit was not needed or what the situation was following the missed visit. RN-B stated with P1’s history of urinary tract infections she would have made sure he was seen with the symptoms that were reported. Upon interview on 5/5/23 at 10:14 a.m. RN-C stated the AL had left a voicemail and she returned the call on 4/13/23. RN-C stated she notified the clinical managers that a PRN nursing visit was needed and to schedule one for catheter complications with a possible infection. RN-C stated once she triages visits, she is not aware when or if visits are completed. Upon interview on 5/5/23 at 11:31 a.m. with an agency team coordinator she stated she was notified that there was an approved PRN visit for P1, and she scheduled the visit to RN-A. The team coordinator stated the visit had been officially missed when checking in the software system. She stated if a clinician is not able to complete a visit, the manager on duty should be notified to make other arrangements. Upon interview on 5/6/23 at 10:12 a.m. the physician stated he was not notified of any missed visit from the HHA for P1 for a 4/13/ PRN visit. He stated he was contacted by the AL on 4/17/23 via the clinics patient portal that indicated P1 had fever ranging from 99.7 – 100.9 F for four days with minimal urinary output from his catheter and mucous in his catheter tubing and the HHA was going to do a PRN visit, however, did not. The provider ordered a chest x-ray and a urinalysis. He stated, “there is a reason the patient has the agency involved with his skilled catheter cares as this has been a persistent problem with him.” The provider also stated when a catheter is malfunctioning the bladder isn’t draining correctly, leaving the urine in the bladder which is host for infections and P1 had multiple signs and symptoms. The provider stated if the 4/13/23 visit had been performed or he had been notified sooner the situation may not have resulted in a hospital admission with the seriousness of sepsis. On 5/5/23 and 5/8/23, attempts were made to contact RN-A via phone. No return call was received. Upon interview on 5/8/23 at 9:03 a.m. RN-D stated the HHA see’s P1 for skilled catheter care as the AL does not perform skilled assessments and treatments for catheters. The services the HHA provided was education and instruction on changing of the catheter leg bags, assess for signs and symptoms of catheter complications. The HHA changed the monthly and PRN for any dislodgement or changes and the HHA was to take a urinalysis if indicated. She stated that the patient and/or caregiver is instructed on when to call the agency for catheter concerns to either triage the situation with a HHA nurse or to have a PRN visit scheduled. RN-D stated the expectation of the HHA is for the patient to be seen for a schedule PRN visit. She was not aware that P1 had a missed visit on 4/13/23. RN-D stated she was not aware of the missed visit stating the nurse assigned to the patient should have called the manager on duty if the visit was missed. She also stated she was not aware how the agency follows missed visits, other than an automatic notification goes out to the physician from the software system once the providing nurse uploads a note. RN-D stated P1’s needs were not met by the HHA. An HHA policy titled Provision of Care and Record Management, Missed Visits policy dated 5/2022, indicated the purpose was to ensure that missed visits are documented and does not affect the quality of patient care. Missed visits will be communicated to the clinical supervisor and the patient’s physician. If a visit is missed and not rescheduled the clinician will. A. Notify the physician and the clinical supervisor of the missed visit and reason for the missed visit. B. Document in the patient’s record the following information: 1. Patient name. 2. Date and type of visit that was missed. 3. Reason for the missed visit. 4. Description of any unmet needs and how the patient’s needs were met. 5. Physician notification date, time, physician name, method of notification and the staff reporting the information. 6. Any other follow-up as needed. 7. Another person(s) that were notified of the missed visit. 8. Signature of the staff member reporting the information.

On 3/24/22 and 3/25/22, an abbreviated survey was conducted to investigate a complaint. The agency was found NOT to be in compliance with the requirements of 42 CFR Part 484, requirements for Home Health Agencies. The following complaints were found to be SUBSTANTIATED: H8118005C and H8118006C with deficiencies issued at G488 and G710. In addition, the Condition of Participation: Skilled Professional Services §484.75 at G700, was found NOT met. As a result an partial extended survey was completed. The facility's plan of correction (POC) will serve as your allegation of compliance upon the Department's acceptance. Federal Law as specified in 42 CFR 484.80 (f)(3), prohibits any home health agency to offer and/or conduct home health aide training and/or competency testing which, within the previous two years has been subjected to an extended or partially extended survey as a result of having been found to have furnished substandard care.

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to immediately report an incident of a medication error for 1 of 3 patients (P1) to the State Agency (SA) reviewed for medication errors. P1's plan of care (POC) for the certification period of 1/9/22 to 3/9/22, indicated P1's diagnoses included ventricular tachycardia, intracardiac thrombosis, hypertensive heart disease with heart failure, chronic systolic congestive heart failure, presence of automatic (implantable) cardiac defibrillator, long term use of anticoagulants and ischemic cardiomyopathy. The POC indicated P1 required skilled nursing visits one time weekly for five weeks for medications education and management, monitoring vital signs, international normalized ratio management (a test that measures the time for the blood to clot used to monitor blood-thinning medicines, which are also known as anticoagulants) (INR), labs and blood draws. In addition, the POC indicated targeted INR range was 2.5 to 3.0. P1’s physician verbal order given to LPN-A by the anticoagulant clinic RN-B dated 3/4/22, indicated “INR result 3.0 via fingerstick. Warfarin 4 mg every day. Recheck on Friday 3/11/22.” During a review of the agency incident self-report to the State Agency dated 3/11/22, the report indicated the writer had received a call from P1’s family member (FM)-A on 3/10/22, stating “there was a medication error in [P1’s] medication [med] set up.” The report indicated P1’s medications were set up on 3/4/22, and P1 started having nosebleed and hematuria (blood in the urine) on 3/8/22. On 3/9/22 registered nurse (RN)-A completed a home visit and at the time RN-A had repeated INR with a result of 11.0. FM-A stated RN-A and FM-B had discovered an incorrect Coumadin dose was set up with medication set up. P1was hospitalized due to elevated INR, nosebleed, and hematuria. During an interview on 3/24/22, at 11:15 a.m. RN-A case manager stated she had updated the agency of the elevated INR and medication error by sending an email the night of 3/9/22 or the following morning to intake to let them know P1 was admitted to the hospital for the elevated INR. RN-A also stated she had also called her supervisors twice that following morning on 3/10/22 and left a voice message then at around 11:00 a.m. she then received a call from the home health administrator, and she then informed her of the medication error and P1’s hospitalization. RN-A acknowledged she did not call the on-call to inform the clinical staff of the medication error. During an interview on 3/24/22, at 12:08 p.m. the home health administrator (HHA) stated she was made aware of the medication error on 3/10/22, first by FM-A and then later that morning she had spoken with RN-A who gave more details about the series of events. The HHA stated her expectation was RN-A was supposed to report by the end of the day the suspected med error to the on-call clinical manager on duty and all the staff knew to call this number even after hours. The HHA stated after she was made aware of the medication error, she had reported it to risk management right away and the case manager at the hospital had also sent me an e-mail and when she called her back, she was informed the hospital had filed a vulnerable adult (VA) report against the agency to the State Agency. The HHA stated she did not file the agency report until 3/11/22, because it was the end of the day on 3/10/22 and she thought because the hospital had filed a report “My urgency was if I was the first person who knew it, I would have done it immediately but they had done it so I did it the next morning. If they had not told me, they had filed I would have filed the VA. This is a learning opportunity about reporting.” During an interview on 3/24/22, at 2:49 p.m. the agency executive director (ED) she was made aware of the delay in reporting, and she would have expected the staff to have reported immediately as this was on the policy and they should have called the on-call as soon as the suspected medication error was identified. The ED acknowledged no training had been offered to other nurses and physical therapy staff who completed start of care cases. The ED stated training was going to be implemented for the staff. The agency's undated Medication Administration Error policy indicated all medication errors will be documented on an incident report and defined a medication error as, but not limited to wrong medication, wrong time, wrong dose, wrong route of administration during intervention by the nurse, extra dose, omission of ordered drug. In addition, the policy directed any medication error will be reported to the clinical director or clinical supervisor and the attending physician. The agency Assessment of Possible Abuse/Neglect policy revised October 2019, directed “Any clinician who discovers, within the course of rendering care, any suspected abuse or neglect will immediately, including after hours, report such occurrences to his/her immediate supervisor…”

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on interview and document review, the agency was found not in compliance with the Condition of Participation at 484.75, Skilled Professional Services. The agency failed to ensure medication was correctly set up for 1 of 3 patients (P1) who received skilled nursing services with medications management. The wrong medication dose resulted in a significant adverse reaction and R1 required hospitalization. Refer to G710: Based on interview and document review, the home health agency (HHA) failed to ensure medication set up was performed correctly for 1 of 3 patients (P1) when a licensed practical nurse (LPN) set up Warfarin (an anticoagulant/blood thinner also known as Coumadin) incorrectly which resulted in a significant adverse reaction and hospitalization for P1.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on interview and document review, the home health agency (HHA) failed to ensure medication set up was performed correctly for 1 of 3 patients (P1) when a licensed practical nurse (LPN) set up Warfarin (an anticoagulant/blood thinner also known as Coumadin) incorrectly which resulted in a significant adverse reaction and hospitalization for P1. P1's plan of care (POC) for the certification period of 1/9/22 to 3/9/22, indicated P1's diagnoses included ventricular tachycardia, intracardiac thrombosis, hypertensive heart disease with heart failure, chronic systolic congestive heart failure, presence of automatic (implantable) cardiac defibrillator, long term use of anticoagulants and ischemic cardiomyopathy. The POC indicated P1 required skilled nursing visits one time weekly for five weeks for medications education and management, monitoring vital signs, international normalized ratio management (a test that measures the time for the blood to clot used to monitor blood-thinning medicines, which are also known as anticoagulants) (INR), labs and blood draws. In addition, the POC indicated targeted INR range was 2.5 to 3.0. P1’s physician verbal order given to LPN-A by the anticoagulant clinic RN-B dated 3/4/22, indicated “INR result 3.0 via fingerstick. Warfarin 4 mg every day. Recheck on Friday 3/11/22.” During a review of the agency incident self-report to the State Agency dated 3/11/22, the report indicated the writer had received a call from P1’s family member (FM)-A on 3/10/22, stating “there was a medication error in [P1’s] medication [med] set up.” The report indicated P1’s medications were set up on 3/4/22, and P1 started having nosebleed and hematuria (blood in the urine) on 3/8/22. On 3/9/22 registered nurse (RN)-A completed a home visit and at the time RN-A had repeated INR with a result of 11.0. FM-A stated RN-A and FM-B had discovered an incorrect Coumadin dose was set up with medication set up. P1was hospitalized due to elevated INR, nosebleed, and hematuria. The report indicated following intervention/resolution comments were on 3/14/22, education was provided to licensed practical nurse (LPN)-A on following the 5 R’s of medication administration right dose, right drug, right route, right client, and right time. In addition, a plan for Educare education and ride a long for medication set up with LPN-A was planned for 3/24/22. During interview on 3/24/22, at 12:58 p.m. FM-B stated on 3/9/22, RN-A had completed a home visit and at the beginning of the visit she had informed RN-A P1 had experienced a nosebleed the night before. FM-B stated at that time RN-A had checked P’s INR using her machine and the reading was 7.0. Then she again had used their machine and gotten the same reading and that was when RN-A called the Coumadin clinic and was instructed to draw blood and bring it in. FM-B stated the clinic had called her and informed them the INR from the lab was 11.0. At this time she spoke to RN-A who instructed her to remove the Coumadin pills still in the pill box which had been set up by LPN-A on 3/4/22, and that was when she found each day left from 3/9/22, to 3/10/22, LPN-A had set up 4 tablets with each being 5 milligram (mg) a total of 20 mg. FM-B stated she had compared the pills with the ones in the two bottles in the home which were 1 mg and 5 mg and they were 5 mg tablets. FM-B stated she then she separated the pills into a Ziploc bag and at P1’s most recent appointment the physician had confirmed they were 5 mg tablets. FM-B stated the physician had told them P1 was lucky to have survived the significant medication error. FM-B stated following the elevated INR P1 had been hospitalized twice because of the medication error and said P1 was devastated, worried about his health and was physically weakened. During interview on 3/24/22, at 11:15 a.m. RN-A case manager stated she remembered the medication error with P1. RN-A stated she had gone to P1’s home to complete a recertification visit and as RN-A entered the home FM-B stated to her something had happened to P1 the previous night and he was lying in bed. RN-A stated she then told both FM-B and P1 because P1 was on Coumadin she was concerned with the nosebleed, and she was going to call the INR clinic to get an order to check the INR at the visit because it was not due until 3/11/22. RN-A stated she then called the clinic and got an order and when she checked the INR using her machine and the patients’ machine, with the finger stick, she had got a result of 7.0 and said the machines would take a long time to give the reading and an error message after. RN-A then stated she had called the INR clinic and had reported to them and at that time she was given another order to do a vein puncture to obtain blood which she got and delivered to the lab. RN-A then stated she had called FM-A who informed her the clinic had called and told her the result for the INR was 11.0 and at this time she had asked FM-B to remove the Coumadin pills from the medications still set up for the reminder days and put them in a Ziploc bag for her to come see later. RN-A also stated she was aware P1 had both doses of Coumadin in the home and when she did the medication set up, she put the dose she was not going to set up aside from other pills. RN-A stated FM-B had informed her the instructions they had received from the clinic however, she felt P1 needed to go to the hospital instead due to the elevated INR. RN-A stated she then called the INR clinic and was informed the physician had recommended P1 to go to the hospital. RN-A then stated she had called FM-B and P1 and encouraged them to go in for evaluation as she did not feel P1 was safe staying at home until 3/11/22, to re-check the INR. RN-A also stated, “I have no reason to doubt her what pills she told me about the pills she had removed from the pill box because she knows the medications and they even have an INR machine in the room which she was assisting him with before we admitted him.” RN-A further stated she had done a follow up with FM-B around 7:30 p.m. and FM-B had informed her P1 was being kept at the hospital for observation related to the elevated INR. When asked who at the agency she had updated about the elevated INR and medication error, RN-A stated she had sent an e-mail that night or morning to intake to let them know P1 was admitted to the hospital for the elevated INR. RN-A also stated she had also called her supervisors twice that following morning on 3/10/22, and left a voice message then at around 11:00 a.m. she then received a call from the home health administrator, and she then informed her of the medication error and P1’s hospitalization. RN-A acknowledged she did not call the on-call to inform the clinical staff of the medication error. During interview on 3/24/22, at 12:08 p.m. the home health administrator (HHA) stated she was made aware of the medication error on 3/10/22, first by FM-A and then later that morning she had spoken with RN-A who gave more details about the series of events. The HHA stated the agency was not made aware of the symptoms until 3/9/22, when RN-A had gone to complete a home visit and based on the INR results she had intervened to ensure P1 received proper treatment. The HHA stated her expectation was RN-A was supposed to report by the end of the day the suspected med error to the on-call clinical manager on duty and all the staff knew to call this number even after hours. The HHA stated after she was made aware of the medication error, she had reported it to risk management right away and the case manager at the hospital had also sent me an e-mail and when she called her back, she was informed the hospital had filed a vulnerable adult (VA) report against the agency to the State Agency. During interview, on 3/24/22, at 3:49 p.m. LPN-A stated on 3/4/22, after checking the INR and calling the result to the INR clinic she was given a verbal order with the next dosage for Coumadin for P1 and at that time she set up the medications including the Coumadin as P1 sat close by. LPN-A stated P1 liked to set the Vitamins in a separate pill planner from the prescription pills and all the medications P1 was supposed to take were stored in a “baggie.” LPN-A stated she had done at least three other visits for P1, and this visit she had gone through the medications first and then started to set them up and had gone through them before she left the home. LPN-A stated although P1 would usually participate in setting the pills up, that visit P1 was distracted with little pillows he had gotten and had asked her what she thought of them. When asked what the Coumadin dosage and INR were for P1, LPN-A stated she could not remember. LPN-A stated she had found out about the medication error from the clinical manager and had gone over the incident then had been educated to prevent medication errors and that morning 3/24/22, she had been out with the clinical manager to do a ride along INR check then medication set up for another patient. LPN-A acknowledged she knew P1 had two bottles of Coumadin in the home but could not remember if they were the same dosage. LPN-A also stated she used the medication list when setting medication up and each nurse was supposed to update the list at each visit, so it was accurate. LPN-A further stated usually when she got verbal orders on the phone, she would write the order on the notebook then read it back to the clinic nurse and then she would transcribe it to the medication list and the orders for the patient. During interview on 3/24/22, at 2:49 p.m. the agency executive director (ED) stated “it was a terrible thing to have happened especially with a high-risk medication.” The ED then stated she did not understand how the nurse did not look at the dosing on the bottle which subsequently caused the medication error. The ED acknowledged no training had been offered to other nurses and physical therapy staff who completed start of care cases. The ED stated training was going to be implemented for the staff. The agency's undated Medication Administration Error policy indicated all medication errors will be documented on an incident report and defined a medication error as, but not limited to wrong medication, wrong time, wrong dose, wrong route of administration during intervention by the nurse, extra dose, omission of ordered drug. In addition, the policy directed any medication error will be reported to the clinical director or clinical supervisor and the attending physician.