Adara Home Health Inc.

“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.”

“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.”

“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.”

“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.”

“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.”