Every finding on record at Arc Therapy Services, LLC

A complaint investigation was completed on 08/16/2022 at the home health provider. The agency had 158 current patients. The complaint is substantiated. One or more of the allegations reported are verified and a condition-level deficiency is identified at 484.30 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care.

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 policy review, clinical record review, and interview, the agency failed to provide an individualized, written plan of care specifying the care and services that met the requirements for the Condition of Participation: Care Planning, coordination of services and quality of care. The agency failed to: - Provide an individualized plan of care that included all required elements (G574); -Ensure drugs, services and treatments are administered only as ordered by a physician (G580); and - Ensure the home health agency (HHA) staff promptly alerted the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggested outcomes are not being achieved and/or that the POC should be altered (G590). The cumulative effect of these deficient practices has the potential to affect the provision of safe care for all patients served by the agency.

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 review of the agency’s policy, clinical record review, home visit observation, and interview, the agency failed to ensure that each patient's written individualized plan of care (POC) included all required elements in, but not limited to, two (Records/Patients #1 and #4) of four records reviewed. This deficient practice has the potential to adversely affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Care Planning and Coordination,” dated April 2022, showed, in part: - Purpose: To provide clinical direction to the clinicians providing direct patient care and outline the process to make a referral for additional services; - The individualized plan of care will be developed together with the patient/representative and approved by the physician responsible for the home health plan of care; - The plan will specify necessary care and services that will be furnished to meet specific patient needs identified in the comprehensive assessment; - All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including but not limited to: * Individualized patient needs and resultant problems related to care and functional status; * Changes in patient’s condition; * Pain and symptom management, as appropriate; - Based on the assessment and conclusions, the plan of care will include, but will not be limited to: * Identified patient problems and needs; * Reasonable, measurable, and individualized goals; * Specific services to be provided; * Actions taken to meet the patient goals; and * Equipment and supplies; and - The plan of care will be based upon the physician’s orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. RECORD/PATIENT #1: Review of the physical therapy admission comprehensive assessment dated 07/06/2022, showed the following: - Diagnosis included diabetes mellitus type two (a chronic condition that affects the way the body processes blood sugar) with hyperglycemia (high blood sugar), and anxiety; - Anxious all of the time for the past 14 days; - Pain impaired body functions that either require home health intervention or will impact the plan of care; - The patient reported acute severe left wrist pain and rated the pain an eight on a scale of zero to ten (zero representing no pain and ten representing the worst pain possible); and - The pain was relieved by ice/heat (no physician orders), medication, and rest/sleep. Review of the plan of care dated 07/06/2022, failed to include anxiousness, pain, hyperglycemia, and how often staff were to measure the patient’s left forearm wound. During an interview on 08/16/2022 at 2:41 PM, registered nurse (RN) A stated that the patient had been in pain since admission to the agency and the plan of care should have included pain. He/she measures wounds weekly. During an interview on 08/16/2022 at 3:27 PM, the clinical manager stated that he/she expected the pain to be included on the plan of care. Staff measure wounds weekly. He/she expected the plan of care to contain individualized interventions for the patient's problems identified. RECORD/PATIENT #4: Review of the RN recertification assessment dated 08/12/2022, showed the following: - Diagnosis included diabetes mellitus type two with other skin ulcer, non-pressure chronic ulcer of right ankle with unspecified severity, bilateral primary osteoarthritis of knee, long term use of insulin and hypoglycemic drugs; - The patient reported chronic lower back pain during the day, current pain rated a three, and the worst pain rated a five. The patient’s acceptable pain level was a four; - The pain was relieved by change of weight bearing, distraction, medications, positioning, and rest/sleep; - Blood sugars were checked three times daily and the blood sugar reading ranged 100 to 200 [Note: the normal range of blood sugar levels are considered between 70 and 99 after fasting/not eating, and less than 140 after eating]; and - Metformin (anti-diabetic medication) 500 milligrams (mg) two times daily; - Insulin glargine (can be used to treat people with type two diabetes and may need insulin to control their diabetes); and - Right lateral ankle wound. Review of the plan of care, dated 06/14/2022 through 08/12/2022, showed blood sugar checked daily (not three times a day per assessment). The plan of care failed to address education on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) and what to do if the patient has these symptoms, blood sugar parameters, and when/what to report to the physician. There was no individual specific interventions and goals for pain control, and how often staff were to measure the wound to the right lateral ankle. During an interview on 08/16/2022 at 12:15 PM, during the patient's home visit, the patient stated that he/she adjusts his/her diabetic medication and checks blood sugars once a day. HIs blood sugar today was 137 and yesterday 107. He/she was taking Jardiance (antidiabetic medication) for the past two months. (Jardiance was not on the plan of care.) He/she takes Metformin 500 mg one tablet every night (the plan of care showed metformin 500 mg two tablets every night). The nurse measures his/her wound weekly. He/she keeps feet elevated which helps with swelling of lower extremities. The patient takes medication almost every night for restless leg syndrome (a condition that causes an uncontrollable urge to move the legs, usually because of an uncomfortable sensation). (The plan of care failed to include any information regarding restless leg syndrome.) Per interview conducted during the patient's home visit, licensed practical nurse (LPN) stated that the Jardiance was discontinued (review of medical record showed Jardiance discontinued on 07/15/2022). He/she asked about changes with the patient’s medication every visit. He/she looked at the medications every week or two. He/she measure wounds weekly.

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 policy review, record review, and interview the agency failed to ensure drugs, treatments and services were administered only as ordered by the physician in two (Records/Patients #1 and #2) of four records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Care Planning and Coordination,” revised April 2022, showed, in part, clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care and obtain orders. The plan of care includes types of services and specific procedures to be performed by nursing and therapies, including frequency, and duration of procedures and visits, patient specific interventions, and all care orders will be recorded in the plan of care. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 07/06/2022. The patient had a wound to his/her left forearm. Review of the occupational therapy add-on evaluation dated 07/07/2022 at 5:44 PM, showed the patient reported complaints of left wrist pain at wound site but no pain today and Ibuprofen relieves pain. There was no physician order for Ibuprofen. Review of the physical therapy visit note dated 07/12/2022 at 9:52 AM, showed ice and heat relieve pain. There was no physician order for ice and heat. During an interview on 08/16/2022 at 9:56 AM, the administrator stated that the patient was using ice and heat and this should have been verified with the physician. He/she would have expected staff to obtain an order for ibuprofen, ice, and heat. RECORD/PATIENT #2 Review of the clinical record showed the patient was admitted on 06/30/2022 with diagnosis of acute and chronic respiratory failure with hypercapnia (excessive carbon dioxide in the bloodstream, typically caused by inadequate respiration), chronic obstructive pulmonary disease with acute exacerbation, and dependent on supplemental oxygen. Skilled nursing visits started on 06/30/2022 and the skilled nurse was to do visits one time a week for one week, then two times a week for one week, and then one time a week for two weeks. The patient had one skilled nurse (SN) visit the week of 07/03/2022 (the patient should have had two SN visits). There was no SN visits the week of 07/17/2022 (there was an order for one SN visit). The agency failed to provide skilled nursing visits per the physician’s orders and there was no documentation to show they offerd to send another nurse or make up the visit on a different day. Review of a complaint report dated 08/09/2022 at 12:00 AM, showed the patient reported feeling like he/she had to beg the nurse to come and see him/her for a couple of weeks. When the nurse was able to come it was the same day his/her physician told him/her to go to the emergency room. The agency follow-up comments showed the patient had scheduled appointment with the nurse on 07/22/2022 and the nurse called in sick (there was no documentation to show the physician was notified of the missed visit and if staff offered the patient if they could make up the visit another day/time or with a another nurse). During an interview on 08/16/2022 at 3:40 PM, the clinical manager stated that the missed visits started increasing in March and April of 2022 and to help the situation the agency has decreased the nurses’ territory, refused some admissions, and have even thought about using agency staff. The patients did not have many missed visits at the current time, they have new clinicians that do not have much home health experience and were learning how to manage the schedule and work autonomous. During an interview on 08/16/2022 at 3:40 PM, the regional director of survey preparedness stated that he/she was unable to find any further information in the medical record regarding the missed visits.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to promptly alert the physician to changes in the patient's condition that may suggest a need to alter the plan of care (POC) in, but not limited to, one (Record/Patient #1) of four records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Care Planning and Coordination,” dated April 2022, showed, in part: - Purpose: To provide clinical direction to the clinicians providing direct patient care and outline the process to make a referral for additional services; and - Any revision to the plan of care due to a change in patient health status will be communicated to the patient, and all physicians issuing orders for the home health agency plan of care. RECORD/PATIENT #1: Review of the physical therapy admission comprehensive assessment dated 07/06/2022, showed the following: - Diagnosis included diabetes mellitus type two (a chronic condition that affects the way the body processes blood sugar) with hyperglycemia (high blood sugar), and anxiety; - The patient reported acute severe left wrist pain and rated the pain an eight on a scale of zero to ten (zero representing no pain and ten representing the worst pain possible); - Left wrist intravenous (IV) site (the IV was removed prior to home health services were started) with infection and cellulitis (a common and potentially serious bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin); and - The documentation failed to show physician notification of the patient’s pain and left wrist cellulitis. Review of the plan of care dated 07/06/2022, signed by the physician on 07/13/2022, showed the following: - Cleanse wound with normal saline, pat dry, cover with four by four, secure with tape, change twice a week and as needed, if soiled; - Skilled nurse to assess/evaluate co-morbid conditions including complications of wound infection that present during the course of this episode to identify significant changes in condition and intervene to minimize complications; and - Goals patient will verbalize/demonstrate understanding of wound care to left forearm including management and ability to perform wound care, wound status will improve as evidenced by optimal wound healing with a decrease in size, drainage, and absence of signs and symptoms of infection to be completed in four weeks. Review of the registered nurse (RN) add-on evaluation dated 07/07/2022 at 2:14 PM, showed: - Left forearm wound, red, and inflamed (no further assessment); and - The patient denied pain during wound care. Review of a client coordination note dated 07/07/2022, showed RN A documented received POC skilled nursing two times a week for wound care per the physician’s nurse. The documentation failed to include physician notification of the left forearm wound being red, and inflamed. Review of the skilled nurse visit note dated 07/13/2022 at 12:01 PM, showed the following: - The left forearm wound assessment showed the length was 2.8 cm (centimeters) by 2.6 cm by 0.1 cm and the surface area was 7.28 cm; - The depth description showed partial thickness (involves epidermis and dermis), small amount of purulent drainage (sign of infection), wound edges distinct, round shape, acute, and signs and symptoms of infection; - The RN called the physician’s nurse for wound care orders, put in orders and wound care supplies, and provided basic first aid care (no documentation of what basic first aid care used); and - RN communicated with the supervisor. Review of a physician order dated 07/13/2022 at 12:01 PM, showed wound care twice weekly. RN to cleanse left wrist trauma wound with wound cleanser, pat dry and apply Aquacel ag (wound dressing) to wound base and secure with ABD pad and Kerlix. Review of the RN visit dated 07/15/2022 at 1:15 PM, showed the following: - The left forearm wound assessment showed the length was 2.8 cm (centimeters) by 2.6 cm by 0.1 cm and the surface area was 7.28 cm; - The depth description showed full thickness (involve the dermis, subcutaneous fat and sometimes bone), small amount of purulent drainage, wound edges not attached, irregular shape; - Wound edges and surrounding tissue macerated (occurs when skin is in contact with moisture for too long and often associated with improper wound care), chronic, and no signs and symptoms of infection; - Waiting for Aquacel ag to be delivered from supply company; and - The documentation failed to show physician notification of the wounds full thickness, edges not attached, irregular shape, and the edge of wound macerated, and wound care supplies (ordered on 07/13/2022) not delivered. Review of the ambulatory referral to home care order, dated 07/18/2022 at 1:43 PM, showed to please send wound care nurse to re-dress the patient’s left wrist wound three times per week plus as needed visits. Review of the nurse’s visit note dated 07/18/2022 at 2:45 PM, showed RN A documented the following: - The patient had daily acute left forearm pain in the upper extremity, rated a four, aching and tender, two is acceptable pain level; - There was surrounding redness to left forearm; - The wound to the left forearm had yellow slough in the wound bed and surrounding skin was inflamed; - The patient was taking ibuprofen for pain (no orders); - Educated the patient on fever, chills, increased redness, increased pain and call physician to report symptoms; - The patient awaiting package for UPS and received incomplete supply order (no documentation to show what supplies were not delivered); - The documentation failed to show physician notification of yellow slough in the wound bed, the surrounding skin was inflamed, the wound was red, moderate drainage and slight pain with wound care and rest, the patient was taking ibuprofen for pain, and supplies not delivered. Review of the skilled nurse visit note dated 07/20/2022 at 5:38 PM, showed RN A documented the following: - Vital sign alert, the pulse was 101 and upper limit 100 [Note: the normal pulse/heart rate for healthy adults ranges from 60 to 100 beats per minute], the patient has anxiety and denies symptoms, "the clinician was to do further documentation if rechecked pulse and if physician was notified, if not resolved”; - Upper left extremity at left forearm was aching, the pain was rated a four and acceptable level of pain was a zero; - The left forearm wound assessment showed the length was 5 cm (increase of 2.2 cm since last assessment on 07/15/2022) by 4 cm (increase of 1.4 cm since last assessment on 07/15/2022) by zero cm and the surface area was 20 cm (increase of 12.2 cm since last assessment on 07/15/2022); - Moderate amount of serosanguinous drainage (wound drainage secreted by an open wound in response to tissue damage); - Total necrotic tissue slough (necrotic tissue that needs to be removed from the wound for healing to take place) 26-50% and total necrotic tissue (black necrotic tissue is formed with healthy tissue dies and becomes dehydrated) of amount 75- 100% (there was no necrotic tissue on 07/15/2022); - Edges and surrounding tissue macerated (occurs when skin is in contact with moisture for too long and often associated with improper wound care), chronic, and no signs and symptoms of infection; and The documentation failed to show physician notification of the increased pulse rate, increase in the size of the wound, increase in total necrotic tissue slough, moderate amount of serosanguinous drainage, edges and surrounding tissue macerated. Review of a complaint report dated 07/22/2022 at 4:05 PM, provided by the agency, showed the patient stated that his/her primary care physician referred him/her to a wound clinic and at the time of his/her appointmnet he/she verbalized his/her unhapiness with the home health agency. He/she was not happpy with the progress of his/her wound and a referral was sent to another home health agency. The patient called on 07/22/2022 at 8:30 AM. Follow-up comments showed the patient was discharged from the agency on 07/22/2022 when the patient called. Review of a physician’s order dated 07/22/2022 at 9:46 AM, showed the patient has requested to be discharged and is going to be admitted to another home health agency. During a telephone interview on 08/16/2022 at 8:00 AM, the patient stated that he/she did not receive the right wound care treatment while he/she was a patient of the agency and the wound continued to get worst. He/she is with a different home health agency now and his/her left forearm wound has healed. During an interview on 08/16/2022 at 2:41 PM, registered nurse (RN) A stated that: - He/she was the nurse that conducted patient #1’s evaluation on 07/07/2022; - The patient had a wound from an IV (intravenous) insertion site that became infected; - The wound that was the size of an eraser and was on top of the left forearm down by the wrist and it had a little center that looked like a needle insertion site, there was redness that went half way up the forearm and inflammation that never went away; - The patient said the wound was painful and draining and he/she tried different dressings. The patient complained of pain since day one of admission; - He/she should have sent the patient back to the hospital and never admitted him/her to home health due to the infiltration of the IV that caused cellulitis to the patient’s left wrist and the physician would not address it; - He/she received wound care orders but not specifics, it was his/her discretion with the wound and he/she applied first aid, which was cleaning the wound and applying a clean gauze; - He/she discussed using Aquacel, which was an absorbent dressing, with the office because the patient said the drainage was soaking the dressing he/she had been using; - There was a mix up with UPS and they did not deliver the Aquacel for a few weeks and staff was using clean gauze and 4x4 until the Aquacel arrived; - On 07/18/2022, he/she visited the patient and did not use the Aquacel because not all of the supplies had been delivered, the wound was a small little dot at that time, like a spider bite, and was inflamed and the measurements included all of the redness surrounding the wound; and - He/she discussed the wound at the initial plan of care and applied first aid until the Aquacel was ordered. There was no more communication with the physician because the patient had an appointment with the physician and referred to the wound care clinic, and this kept him/her from having to call the physician and the “wound care center was not impressed.” During an interview on 08/16/2022 at 3:27 PM, the clinical manager stated that he/she would have expected the physician to be notified of the patient’s pain and changes with the wound. The staff should have called for a different order if the dressing was not available. There was no further information provided.