Every finding on record at Primrose Home Care, Inc.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the agency did not participate in a full-scale exercise that was community-based. Findings include: On 4/17/23, a review of the agency's emergency plan and documentation was completed. No documentation could be located to indicate that the agency had participated in a full-scale, community-based exercise. On 4/17/23, at 12:32 PM, an interview was conducted with the administrator. The administrator confirmed a full-scale exercise that was community-based was not done.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined that the comprehensive assessment was not completed within 5 days from the start of care date for 1 of 7 sampled patients. Specifically, a referral for occupational therapy (OT) to evaluate a patient was not completed after the patient was admitted to the agency. (Patient identifier: 2) Findings Include: Patient 2 was admitted to the agency on 3/16/23, with a primary diagnosis of rheumatoid arthritis. Patient 2's medical record review was completed on 4/17/23. On patient 2’s referral dated 3/13/23, it was ordered for PT/OT (physical therapy/occupational therapy) to evaluate the patient. No OT evaluation was completed in patient 2’s medical record. There was no documentation in patients 2 medical record as to why OT did not evaluate. On 4/12/23 at 12:06 PM, the agency’s operations manager (OM) was interviewed. He was asked why OT did not go out to see patient 2. He stated patient 2 refused. He was not sure why it was not documented. The OM stated they needed to be better at documenting.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on interview and record review all comprehensive assessments did not accurately reflect the patients’ status. Specifically, 1 out of 1 sampled patient with wounds did not have an accurate comprehensive assessment that included all the patients’ wounds. (Patient identifier: 2) Findings include: Patient 2 was admitted to the agency on 3/16/23, with a primary diagnosis of rheumatoid arthritis. Additional diagnoses included: stage 2 and stage 3 pressure ulcers. Patient 2's medical record review was completed on 4/17/23. On 3/16/23, it was documented in the nurse’s initial assessment that there were two wounds. The first wound was a stage two pressure ulcer on the right ankle. The second wound was a stage three pressure ulcer located on the patient’s tailbone. These were the only documented wounds in the nursing assessment. On 3/21/23, it was documented in a physical therapy (PT) note, “patient has wounds in both feet and is non ambulance (sic) ambulatory at this time. She is having difficulty with transfers and strength. She states she also has a wound on her sacrum.” Additionally, the PT documented the, “patient has wounds on sacrum and feet which RN is treating.” On 3/23/23, it was documented in a physical therapist assistant (PTA) note that weight bearing was contraindicated due to open wounds on the plantar surface of both feet. On 4/12/23 at 11:00 AM, the Director of Nursing (DON) was interviewed. The DON was also patient 2’s case manager and nurse. The DON stated patient 2 did not have open wounds on the bottom of her feet. He stated she only had a wound on her coccyx and on her one ankle. On 4/13/23 at 8:00 AM, home health aide (HHA) 2 was interviewed. She stated patient 2 had open wounds on both feet as well as open wounds on her bottom and elbow. She stated she was not sure if patient 2 had a wound on her ankle, that her feet were always wrapped above her ankles. On 4/13/23 at 1:48 PM, the PTA treating patient 2 was interviewed. (Note: the PTA was also a relative of patient 2.) The PTA stated patient 2 had wounds on both elbows, both feet, and one on her ankle. He further stated patient 2 had a wound at the base of her toe that would gush out a "watery goo" when you pushed on it. He stated he would clean and dress that wound every other day. The PTA stated patient 2 also had a pressure ulcer on her sacrum that was “gapping, huge.” There was no documented evidence of patient 2’s additional wounds on both elbows and both feet in the nursing assessments. There was not a clear and concise comprehensive assessment of patient 2. Every discipline documented something different. On 4/3/23, patient 2 had a physician visit to assess the wounds on her feet. The physician determined her right foot was infected and immediately transferred the patient to the hospital.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview and record review, it was determined the agency failed to provide care planning, coordination of services, and quality of care as required. Findings include: 1. The agency failed to ensure the individualized plan of care included the frequency and duration of patient visits to be made. Refer to tag G574. 2. The agency failed to ensure all treatments were administered only as ordered by the physician. Refer to tag G580. 3. The agency failed to coordinate delivery of care to meet the patient's needs. Refer to tag G608.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined for 6 of 7 sampled records, that the individualized plan of care did not include the frequency and duration of the visits to be made. Specifically, a range of visits to be made were documented without the duration for each discipline. (Patient identifiers: 2, 3, 4, 5, 6 and 7) Findings include: The medical records for patients 2, 3, 4, 5, 6 and 7 were reviewed. The following durations were documented: a. Patient 2: Home health aide (HHA) 3 times a week without a duration. b. Patient 3: Physical therapy (PT) 1-3 times a week without a duration; and a HHA 1-3 times a week without a duration. c. Patient 4: PT 1-3 times a week without a duration; and a HHA 1-3 times a week without a duration. d. Patient 5: PT 1-3 times a week without a duration; and a HHA 1-3 times a week without a duration. e. Patient 6: HHA 1-3 times a week without a duration. f. Patient 7: PT 1-3 times a week without a duration. In an email from the agency’s operations manager dated 4/13/23 and timed 4:05 PM, it was documented, “We spoke with the RN. It sounds like there was a misunderstanding on how to put those into the software. That’s something we need to do better at educating them on. We will correct the 485s and get them sent back to the doctors to re-sign asap. We will also be better about reviewing our 485s before we send them out.” (Note: Deficiencies were written in this area on the previous survey.)

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the agency did not ensure all treatments were administered only as ordered by the physician. Specifically, for 1 of 1 sampled patient with wound care orders, the registered nurses (RN), home health aide (HHA), and physical therapist assistant (PTA) were performing wound care that was not ordered by a physician. (Patient identifier: 2) Findings include: Patient 2 was admitted to the agency on 3/16/23, with a primary diagnosis of rheumatoid arthritis. Additional diagnoses included: stage 2 and stage 3 pressure ulcers. Patient 2's medical record review was completed on 4/17/23. Patient 2’s referral dated 3/13/23, included wound care needs. It was documented on the history and physical provided with the referral the sacral pressure ulcer was being treated with “medihoney topical and border foam dressing.” Patient 2’s plan of care (POC) was reviewed. It was documented under orders and treatments, “change or removal of nonsurg (nonsurgical) wound dressing.” There were no other wound care orders in patient 2’s medical record. (Note: The nurse was only scheduled to go out 4 visits as needed, there was no duration and frequency of when wound care should be done.) On 3/16/23, it was documented in the nurse’s initial assessment that there were two wounds. The first wound was a stage 2 pressure ulcer on the right ankle. The assessment stated it was being treated with an ABD pad and an island dressing. The second wound was a stage 3 pressure ulcer located on the patient’s tailbone. The assessment stated that the treatment was collagen packing, honey, and an island dressing. There was no documented evidence of an order for this treatment in patient 2’s medical record. On 3/29/23, it was documented in HHA 2's visit note that patient 2’s sore on their bottom was treated with “cream and bandage.” On 4/3/23, the PTA documented, “patient seen by a foot and ankle specialist last week in SLC, UT. on Mar. 26th and was diagnosed with Charcots Syndrome of the right ankle. The open wound on the Lateral Malleolous of the right foot is infected as well as infection of open wound of the plantar surface of left foot. Dr. states…dressing change on wounds every other day. Wound care has taken place per Dr.'s orders.” (Note: There were no wound care orders in patient 2's medical record.) On 4/12/23 at 11:00 AM, the Director of Nursing (DON) was interviewed. The DON was also patient 2’s case manager and nurse. He stated there were no orders for wound care in patient 2’s medical record. The DON stated he was just doing what the nursing home where she previously resided told him they had been doing. He further stated patient 2 did not want the wound care done that had been done at the nursing home so he switched to using just antibiotic ointment and an island dressing. He stated he did not have orders for that switch. The DON stated he would see the patient every week and the HHA would do the dressing changes in-between. On 4/13/23 at 8:00 AM, HHA 2 was interviewed. She stated patient 2 had open wounds on both feet as well as open wounds on her bottom and elbow. She stated she was not sure if patient 2 had a wound on her ankle, that her feet were always wrapped above her ankles. HHA 2 stated she was only treating the wounds on patient 2’s bottom and elbow. She stated she would use “bag balm (a cream) and a bandage.” She stated the DON, patient 2’s nurse gave her instructions on what to use. On 4/13/23 at 1:48 PM, the PTA treating patient 2 was interviewed. (Note: the PTA was also a relative of patient 2.) The PTA stated patient 2 had wounds on both elbows, both feet, and one on her ankle. He further stated patient 2 had a wound at the base of her toe that would gush out a "watery goo" when you pushed on it. He stated he would clean and dress that wound every other day. The PTA stated patient 2 also had a pressure ulcer on her sacrum that was “gapping, huge.” He further stated he did not have anything to pack it with, so he used honey gel and a dressing. He stated he would change it every day. He was asked if there were any physician orders or any communication with a physician. He stated there were no wound care orders. He further stated patient 2’s doctor said to just “dress the wounds.” He stated the nurse liked to use bag balm and honey gel. He stated, “I just did what I could with the supplies that I had.” He stated, "the nurse was doing wound care once a week and I was doing wound care every day." He further stated the patient was not seeing anyone separately for her wounds at this time, it was just them managing her wounds. The PTA stated she went to a doctor’s appointment the week before she was transferred. (Patient 2 was transferred on 4/3/23.) The physician determined her toes were destroyed and would have to be removed. The PTA further stated a week later, at a doctor’s appointment, the physician realized there was an infection, and she was immediately admitted to the hospital. On 4/17/23 at 12:30 PM, an interview was conducted with the administrator. He stated what happened with patient 2 was unacceptable and that several people dropped the ball in caring for patient 2. There was no documented evidence a physician ordered the different techniques/treatments used nor was there documented evidence that the agency had informed or been in communication with a physician about these treatments. It was difficult to determine how often patient 2 was getting wound care, who was supposed to be doing the wound care, what the wound care was supposed to be, and how often it should have been done.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the agency did not coordinate delivery of care to meet the patient's needs. Specifically, for 1 of 1 sampled wound care patient the agency did not ensure there was coordination between caregivers to meet the patients wound care needs. (Patient identifier: 2) Findings include: Patient 2 was admitted to the agency on 3/16/23, with a primary diagnosis of rheumatoid arthritis. Additional diagnoses included: stage 2 and stage 3 pressure ulcers. Patient 2's medical record review was completed on 4/17/23. On 3/16/23, it was documented in the nurse’s initial assessment that there were two wounds. The first wound was a stage 2 pressure ulcer on the right ankle. The assessment stated it was being treated with an ABD pad and an island dressing. The second wound was a stage 3 pressure ulcer located on the patient’s tailbone. The assessment stated that the treatment was collagen packing, honey, and an island dressing. There was no documented evidence of a physicians order for this treatment in patient 2’s medical record. On 3/21/23, it was documented in a physical therapist (PT) note, “patient has wounds in both feet and is non ambulance (sic) ambulatory at this time. She is having difficulty with transfers and strength. She states she also has a wound on her sacrum.” Additionally, the PT documented, “patient has wounds on sacrum and feet which RN is treating.” On 4/12/23 at 11:00 AM, the Director of Nursing (DON) was interviewed. The DON was also patient 2’s case manager and nurse. The DON stated patient 2 did not have open wounds on the bottom of her feet. He stated she only had a wound on her coccyx and on her one ankle. (Note: The PT documented in the above note the nurse was treating wounds on her feet.) On 4/13/23 at 8:00 AM, home health aide (HHA) 2 was interviewed. She stated patient 2 had open wounds on both feet as well as open wounds on her bottom and elbow. She stated she was not sure if patient 2 had a wound on her ankle, that her feet were always wrapped above her ankles. HHA 2 further stated that a physician was treating the wounds on her feet once a week and that the family was doing wound care in-between. HHA 2 stated she was only treating the wounds on patient 2’s bottom and elbow. She stated she would use “bag balm (a cream) and a bandage.” She stated the DON, patient 2’s nurse gave her instructions on what to use. (Note: There was no documented evidence in the medical record of a physician treating patient 2's wounds.) On 4/13/23 at 1:48 PM, the physical therapist assistant (PTA) treating patient 2 was interviewed. (Note: the PTA was also a relative of patient 2.) The PTA stated patient 2 had wounds on both elbows, both feet, and one on her ankle. He further stated patient 2 had a wound at the base of her toe that would gush out a "watery goo" when you pushed on it. He stated he would clean and dress that wound every other day. The PTA stated patient 2 also had a pressure ulcer on her sacrum that was “gapping, huge.” He further stated he did not have anything to pack it with, so he used honey gel and a dressing. He stated he would change it every day. He was asked if there were any physician orders or any communication with a physician. He stated there were no wound care orders; patient 2’s doctor said to just “dress the wounds.” He stated the nurse liked to use bag balm and honey gel. He stated, “I just did what I could with the supplies that I had.” He stated, "the nurse was doing wound care once a week and I was doing wound care every day". He further stated the patient was not seeing anyone separately for her wounds at this time, it was just them managing her wounds. The PTA stated she went to a doctor’s appointment the week before she was transferred. (Patient 2 was transferred on 4/3/23.) The physician determined her toes were destroyed and would have to be removed. He stated she was diagnosed with Charcot syndrome. The PTA further stated a week later, at a doctor’s appointment, the physician realized there was an infection, and patient 2 was immediately admitted to the hospital. There was no documented evidence of coordination between disciplines regarding patient 2’s wound care. Every discipline stated something different. It was difficult to determine how often patient 2 was getting wound care, who was supposed to be doing the wound care, what the wound care was supposed to be, and how often it should have been done.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on interview and document review, it was determined the agency failed to maintain a home health-wide data-driven quality assessment and performance improvement (QAPI) program. Specifically, the agency failed to develop, implement, evaluate, and maintain an effective, ongoing, QAPI program which reflected the complexity of its organization and services. Findings include: The agency failed to provide evidence, by interview or documentation; they had developed, implemented, evaluated, and maintained an effective, ongoing, agency-wide data-driven QAPI program which reflected the complexity of its organization and services. Therefore, none of the standards (tags: G644, G646, G648, G650, G652, G654, G656, G658, and G660) under this condition were met. On 3/10/23,the QAPI plan, QAPI meeting minutes (MM), and QAPI performance improvement projects (PIPs) were requested, All that was provided regarding the requested QAPI items was some tracking from 2022. The tracking included: falls, transfer and discharge policy, visit orders and 485, plan of care, patient vaccination, infection control education, background checks and CPR, and emergency preparedness. The agency could not provide any documented evidence of using this tracking information to implement PIPs, changes in processes, policies and procedures, etc. The operations manager (OM) stated via email on 4/13/23 at 11:19 AM, he sent us everything they had for QAPI. The OM was not aware of what PIPs were and was not aware of all the QAPI regulations. The OM provided quality improvement committee (QIC) MM documents dated 4/4/22 and 1/10/23; and a GB MM document dated 10/14/22. Review of the GB and QIC MM documentation revealed it was minimal and did not provide any evidence of a QAPI program which reflected the complexity of its organization and services. Additionally, the agency could not provide evidence of GB oversight to ensure the agency had an ongoing QAPI program. (Note: It was documented in the GB MM dated 10/14/22, that the agency will, "develop a quality assurance program.")

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: The agency failed to maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. Findings include: The agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the agency’s quality assessment and performance improvement program. Refer to tag G684.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the agency did not maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the agency’s quality assessment and performance improvement (QAPI) program. Findings include: On 4/12/23, surveyors requested the agency’s infection control program and surveillance data. The agency provided infection control policy and procedure documents and logs for staff and patient infections. There was no further evidence provided that the agency maintained a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that was an integral part of the agency’s QAPI program. On 4/17/23 and 12:00 PM, an interview was conducted with the administrator (ADM). The ADM stated they needed to work on the infection control program. He stated that he had a person in mind to delegate putting together a program.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the agency did not ensure skilled professional services were delivered according to the agency’s policies and procedures. Specifically, for 1 of 1 sampled patient with wounds, a skilled nurse was not assessing and providing wound care per policy. Additionally, a home health aide (HHA) was providing wound care outside of their scope of practice. (Patient identifier: 2) Findings include: Patient 2 was admitted to the agency on 3/16/23, with a primary diagnosis of rheumatoid arthritis. Additional diagnoses included: stage 2 and stage 3 pressure ulcer. Patient 2's medical record review was completed on 4/17/23. Patient 2’s referral dated 3/13/23, was for the patient to receive PT/OT (physical therapy/occupational therapy) and wound care. 1. On 3/16/23, it was documented in the nurse’s initial assessment that there were two wounds. The first wound was a stage 2 pressure ulcer on the right ankle. It was documented that the wound was 1.2 centimeters (cm) in length and 1.2 cm in width, and 0.2 cm in depth, with tunneling. The assessment stated it was being treated with an ABD pad and an island dressing. The second wound was a stage 3 pressure ulcer located on the patient’s tailbone. It was documented that the wound was 2 cm in length, 1.7 cm in width, and 1.2 cm in depth, with tunneling. The assessment stated that the treatment was collagen packing, honey, and an island dressing. Wound measurements were only done on the initial assessment. There was no other documented assessment of patients 2’s wounds. A review of the policy titled “Photo Documentation” was completed on 4/17/23. It was documented under purpose: -To document the initial condition of the client’s skin upon admission. -To document clear, accurate status of skin condition. -To document objective images of the outcomes of treatment for referral and payer sources. - To facilitate communication between the treatment team and prescribing physician. There was no documented evidence of pictures of any wounds in patient 2’s medical record. A review of the policy titled “Pressure Ulcer Dressing Changes” was completed 4/17/23. It read under documentation guidelines, that the following should be documented in the medical record when doing dressing changes: -Date and time of procedure. -Specific treatment. -Location, size of ulcer. -Color and appearance of wound bed. -Amount color and consistency of drainage. -Condition of surround tissue. -Change in general condition – complaints of pain, elevated temperature. -Physician notification -Preventive measure taken. -Teaching done. -Client response. There was no documented evidence patient 2’s nurse followed policy and procedures when documenting dressing changes. On 4/12/23 at 12:06 PM, the agency’s operations manager (OM) was interviewed. He was asked if there should be pictures of wounds in patient records and how often wounds should be measured and assessed. The OM stated he was not super familiar with their wound care policy and that we should ask their Director of Nursing (DON). On 4/12/23 at 11:00 AM, the DON was interviewed. The DON was asked how often wounds should be assessed and measured. He stated, “I don’t think I was doing it as much as I was supposed to. It should be done as least once a week.” The DON was asked if there should be pictures of the wounds in the medical record. He stated there was not any photos in patient 2’s medical record and that he was not very familiar with providing wound care. He further stated they do not do a lot of wound care. 2. All the agencies’ wound care policies were reviewed. None of the policies noted that it was within the scope of practice of an HHA to provide any sort of wound care. On 3/29/23, it was documented in HHA 2's visit note, that patient 2’s sore on their bottom was treated with “cream and bandage.” On 4/13/23 at 8:00 AM, HHA 2 was interviewed. She stated patient 2 had open wounds on both feet as well as open wounds on her bottom and elbow. HHA 2 stated she was only treating the wounds on patient 2’s bottom and elbow. She stated she would use “bag balm (a cream) and a bandage.” She stated the DON, patient 2’s nurse, gave her instructions on what to use. On 4/12/23 at 11:00 AM, the DON was interviewed. The DON was also patient 2’s case manager and nurse. The DON stated he would typically go out to see patient 2 every week and the HHA would do the wound care in-between his visits. He was asked what training the HHA's received. He stated they were trained on simple dressing changes and signs and symptoms of infection. On 4/12/23 at 12:06 PM, the operations manager (OM) was interviewed. The OM stated he believed the HHAs were trained on wound care. He further stated they were mainly trained on reporting signs and symptoms; they were not allowed to do wound care. On 4/12/23, the OM was asked what guidelines they follow for wound care of pressure ulcers. He replied via email on 4/13/23 at 1:13 PM, “We don’t have guidelines for that. We sent you everything we have regarding it (pressure ulcer wound care guidelines). Our aides (HHA) typically do not provide stage 3 wound care…In reviewing the record we realize this should have been completed by a nurse.”

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: The agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The agency failed to assure that administrative and supervisory functions were not delegated to another agency or organization, and all services not furnished directly were monitored and controlled. The agency failed to set forth, in writing, its organizational structure, including lines of authority, and services furnished. Findings include: 1. The agency failed to ensure it hired qualified personnel. Refer to tag G952. 2. The agency failed to ensure that one or more qualified individuals provided oversight of all patient care services and personnel. Refer to tag G958. 3. The agency failed to ensure the comprehensive assessment was completed within 5 days from the start of care. Refer to tag G520. 4. The agency failed to ensure the comprehensive assessment accurately reflected the patient's status. Refer to tag G526. 5. The agency failed to provide care planning, coordination of services, and quality of care as required. Refer to tag G570. 6. The agency failed to maintain a home health-wide data-driven quality assessment and performance improvement program. Refer to tag G640. 7. The agency failed to maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. Refer to tag G680. 8. The agency failed to ensure skilled professional services were delivered according to the agency’s policies and procedures. Refer to tag G702. 9. The agency failed to ensure participation in a full-scale community-based emergency preparedness exercise. Refer to tag G0039.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the agency did not ensure it hired qualified personnel. Specifically, for 11 of 11 contracted employees, the agency did not perform a skills assessment. Findings include: On 4/13/23 at 12:29 PM, surveyors asked via email if the agency did skills assessments for contracted employees. An email response at 12:39 PM, from the agency’s operations manager read as follows: “We don’t…We’ll be aware of that moving forward.” The agency could not provide evidence that they had assessed skills of contracted staff prior to them performing patient care. (Note: Deficiencies were written in this area on the previous survey.)

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the agency did not ensure that one or more qualified individuals provided oversight of all patient care services and personnel. Findings include: On 4/12/23 at 11:00 AM, an interview was conducted with RN 8. RN 8 was asked if he was the director of nursing (DON). RN 8 stated. "Not really, I do all the training and stuff with the aides so maybe that's my title but maybe it's (Name)." On 4/12/23 at 12:15 PM, an interview was conducted with the agency's operations manager (OM). The OM was asked who the DON was. The OM stated that RN 8 was the DON. On 4/12/23 at 1:20 PM, a document titled Director of Nursing was provided to surveyors. It detailed the job description of the DON. The details reflected the responsibilities outlined in tags G960, G962, G964, G966, and G968 under this standard. It was signed by RN 8 and dated 6/1/2020.