Every finding on record at Amedisys North Carolina, L.L.C.

An onsite recertification and follow up survey was conducted 10/23/23-10/25/23. No deficiencies to the Emergency Preparedness Program were identified.

An onsite recertification and follow up survey was conducted 10/23/23-10/25/23. Immediate Jeopardy was identified on 10/24/23 at 4:36 p.m. beginning 05/16/23 and was cited at G704- Responsibilities of skilled professionals. Then immediate jeopardy was abated on October 25, 2023 at 3:34 p.m. but continued at a lower level with condition and standard level non-compliance. The agency was notified of the immediate jeopardy on October 23, 2023 at 4:36 p.m. The physical therapy assistant identified a new wound located on the left great toe on 5/16/23. An order for the skilled nurse to evaluate was obtained and the RN made a visit on 5/19/23. The RN documented a wound on the left great toe measuring 2 cm x 1cm x 1 cm. The patient was admitted to the hospital on 6/14/23 and with a diagnosis of diabetic foot infection and underwent partial amputation of the left great toe. There was no follow up with the physician from 5/19/23-6/14/23.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on agency policy, clinical record review and staff interviews, the agency failed to ensure accuracy of the OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] for 6 of 18 records reviewed [#1, 5, 11,12, 14 and 16]. The findings included: The policy, Oasis Outcome and Information Set [6/23/23], was provided by the area vice president on 10/25/23 at 12:22 pm. The policy stated, “…OASIS data will be accurate…will accurately represent the patient’s status at the time of the assessment…” 1. Patient # 1 had a Start of Care [SOC] date of 5/22/23 and admission diagnoses of cirrhosis of liver [type of liver damage where healthy cells are replaced by scar tissue and diabetes mellitus. Review of the Plan of Care for the certification period 5/22/23 to 7/20/23 included orders for SN [skilled nursing] 1 time a week for 3 weeks, 1 time a week every 2 weeks for 6 weeks. Review of the clinical record revealed RN # 9 completed the SOC OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] on 5/22/23. Review of the OASIS documentation revealed RN # 9 failed to include the patient’s medication regimen included the use of an anticoagulant. The patient was taking Eliquis 5 mg twice daily. During an interview with RN # 9 on 10/25/23 at approximately 9:10 am, the RN confirmed the OASIS information related to medications was incorrect. 2. Patient # 5 had a Start of Care [SOC] date of 5/31/23 and admitting diagnoses of type 2 diabetes mellitus with hyperglycemia, type 2 diabetes with diabetic autonomic neuropathy [damage to nerves that control the internal organs], type 2 diabetes mellitus with diabetic polyneuropathy [progressive death of nerve fibers, which leads to loss of nerves, increased sensitivity, and the development of foot ulcers] and type 2 diabetes with diabetic peripheral angiopathy without gangrene [ narrowing in the arteries which results in an undersupply of blood and oxygen to different organs and can lead to damage in the long term]. Review of the Plan of Care for the certification period 3/31/23-5/29/23 included orders for PT [physical therapy] 1 time a week for 5 weeks, 1 time every 2 weeks for 2 weeks, 1time a week for 2 weeks. Review of the clinical record revealed PT [physical therapy] #3 completed the SOC OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] on 3/31/23. Review of the OASIS documentation revealed PT # 3 failed to include the patient’s medicine regimen of Humalog and Levemir insulins. During an interview with PT # 3 on 10/25/23 at approximately 9:15 am, PT # 3 stated, “I guess I just missed those.” 3. Patient # 11 had a Start of Care [SOC] date of 10/5/23 and an admitting diagnosis of pneumonia. Review of the Plan of Care [POC] for the certification period 10/5/23-12/3/23 included orders for PT [physical therapy] 1 time a week for 5 weeks and 1 time every 2 weeks for 4 weeks. Review of the clinical record revealed PT # 3 completed the SOC OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] on 10/5/23. Review of the OASIS documentation revealed PT # 3 indicated patient # 11” s medication regimen included an antipsychotic medication. Review of the clinical record revealed the patient’s medication regimen did not include use of an antipsychotic. Further review of the clinical record revealed the patient’s medication regimen included the use of Eliquis [anticoagulant]. The OASIS did not indicate use of anticoagulant. During an interview with PT # 3 on 10/25/23 at approximately 9:15 am, PT # 3 stated, “You are correct on both accounts. That was an error I made.” 4. Patient # 12 had a Start of Care [SOC] date of 10/2/23 and an admitting diagnosis of unspecified dementia. Review of the Plan of Care [POC] for the certification period 10/2/23-11/30/23 included orders for PT [physical therapy] 2 times a week for 2 weeks, 1 time a week for 7 weeks. Review of the clinical record revealed PT # 4 completed the SOC OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] on 10/2/23. Review of the OASIS documentation revealed PT # 4 indicated patient # 14’s medication regimen included an antipsychotic medication. Review of the clinical record revealed the patient’s medication regimen did not include use of an antipsychotic. During an interview with PT # 4 on 10/25/23 at approximately 9:30 am, the PT stated, “I always count the antidepressant medication as an antipsychotic medication.” 5. Patient # 14 had a Start of Care [SOC] date of 10/2/23 and admitting diagnoses of encounter for other orthopedic aftercare and radiculopathy [injury or damage to nerve roots in the area where they leave the spine]. Review of the Plan of Care [POC] for the certification period 10/2/23-11/30/23 revealed orders for PT [physical therapy] 3 times a week for 1 week, 2 times a week for 1 week, 1 time a week for 7 weeks. Review of the clinical record revealed PT # 4 completed the SOC OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] on 10/2/23. Review of the OASIS documentation revealed PT # 4 indicated patient # 14’s medication regimen included an antipsychotic medication. Review of the clinical record revealed the patient’s medication regimen did not include use of an antipsychotic. During an interview with PT # 4 on 10/25/23 at approximately 9:30 am, the PT stated, “I always count the antidepressant medication as an antipsychotic medication.” 6. Patient # 16 had a Start of Care [SOC] date of 9/20/23 and admitting diagnosis of hypo-osmolality [condition where the levels of electrolytes, proteins, and nutrients in the blood are lower than normal] and hyponatremia [low sodium]. Review of the Plan of Care for the certification period 9/20/23-11/15/23 included orders for PT [Physical therapy] 1 time a week for 1 week, 2 times a week for 1 week, 1 time a week for 3 weeks, 1 time every 2 weeks for 4 weeks. Review of the clinical record revealed PT # 4 completed the SOC OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] on 9/20/23. Review of the OASIS documentation revealed PT # 4 indicated patient # 16’s medication regimen included an antipsychotic medication. Review of the clinical record revealed the patient’s regimen did not include an antipsychotic. During an interview with PT # 4 on 10/25/23 at approximately 9:30 am, the PT stated, “I always count the antidepressant medication as an antipsychotic medication.”

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 agency policy review, clinical record review and staff interviews the Plan of Care [POC] failed to include all current/correct medications the patient was using for 5 of 6 home visits observed (#6, #9, #10, #11, and #12), failed to include all DME (durable medical equipment) for 1 of 5 home visits (#6), failed to include all diagnoses for 1 of 18 records reviewed (#14). The findings included: 3. Patient # 10 had a Start of Care date of 12/1/22 and an admitting diagnosis of other symptoms and signs with cognitive functions following cerebral infarction [stroke]. Review of the Plan of Care [POC] for the certification period 9/27/23 -11/25/23 included orders for PT [physical therapy] 1 time a week for 8 weeks. On 10/23/23 at approximately 1:30 pm a joint visit was made with PT # 4. During the visit a medication review was conducted using a medication profile provided by the agency. The following discrepancies were noted: The medication profile listed Calcitirol [supplement] 0.25 mg take Monday, Wednesday and Friday. During an interview with the caregiver, the caregiver reported the patient has not taken that medication “for some time now”. During an interview with RN # 1 on 10/24/23 at approximately 3:30 pm, RN # 1 confirmed the POC was not correct related to medications. 4. Patient # 11 had a Start of Care date of 10/5/23 and an admitting diagnosis of pneumonia. Review of the Plan of Care [POC] for the certification period 10/5/23-12/3/23 included orders for PT [physical therapy] 1 time a week for 5 weeks and 1 time every 2 weeks for 4 weeks. A home visit was conducted with PTA [physical therapy assistant] # 8 on 10/24/23 at approximately 10:30 am. During the visit a medication review was conducted using a medication profile provided by the agency. The following discrepancies were noted: Temazepam [used for sleep] 7.5 mg take 1 pill at bedtime was noted on the profile. During a review of the medications the bottle of Temazepam dated 8/24/23 was noted with the instructions to take 1 PRN [as needed]. During an interview with the caregiver, the caregiver reported the patient only takes when “she can’t fall asleep”. During an interview with RN # 1 on 10/24/23 at approximately 3:30 pm, RN # 1 confirmed the POC was not correct related to medications. 5. Patient # 12 had a Start of Care [SOC] date of 10/2/23 and an admitting diagnosis of unspecified dementia. Review of the Plan of Care [POC] for the certification period 10/2/23-11/30/23 included orders for PT [physical therapy] 2 times a week for 2 weeks, 1 time a week for 7 weeks. On 10/24/34 at approximately 1 pm, a joint visit was made with PTA [physical therapy assistant] #11. During the visit a medication review was conducted using a medication profile provided by the agency. The following discrepancy was noted: The medication profile did not include ferrous sulfate [iron supplement] 324 mg. During an interview with the caregiver, the caregiver presented a bottle of ferrous sulfate and advised the patient had been on the medication for several years. During an interview with RN # 1 on 10/25/23 at approximately 3:30 pm, RN # 1 confirmed the POC did not include all medications the patient was using. 6. Patient # 14 had a Start of Care date of 10/2/23 and admitting diagnoses of encounter for other orthopedic aftercare and radiculopathy [injury or damage to nerve roots in the area where they leave the spine]. Review of the Plan of Care [POC] for the certification period 10/2/23-11/30/23 revealed orders for PT [physical therapy] 3 times a week for 1 week, 2 times a week for 1 week, 1 time a week for 7 weeks. Further review of the POC revealed the following information: safety precautions included diabetic precautions; nutritional requirements listed as diabetic; the medication regimen included the use of Metformin ER [diabetic medication] and Trulicity [insulin]. The POC did not include Diabetes Mellitus as a diagnosis. During an interview with RN # 2 on 10/25/23 at approximately 1pm, RN # 2 confirmed Diabetes Mellitus should have been included on the POC. The policy, “Physician Orders and Medical Supervision of the Plan of Care”, revised 6/22/23 was provided by the agency director on 10/25/23 at 12:00 p.m. The policy stated, "...the current 485/plan of care will include...all pertinent diagnoses…supervision of medications and treatments…types of services, supplies and equipment required…" 1.Patient #6 was admitted on 9/21/23 with diagnoses of bilateral primary osteoarthritis of knee (joint disease), chronic pain syndrome, and bursitis (inflammation in the fluid filled sac) of left shoulder. The Plan of Care (POC) for 9/21/23-11/19/23 included orders for physical therapy 1 time a week for 5 weeks, occupational therapy 2 times a week for 1 week, 1 time a week for 4 weeks, and 1 time a week every 2 weeks for 2 weeks. A home visit was conducted with the occupational therapist on 10/23/23 at 12:30 p.m. A medication review was conducted and revealed the following discrepancy: -oxygen 2 liters via nasal cannula continuous setting for breathing difficulties was omitted from the plan of care. Interview with the patient on 10/23/23 at 12:33 p.m. revealed she had been on oxygen for 6 weeks. Interview with the physical therapist on 10/25/23 at 9:27 a.m. revealed, “I probably just overlooked putting it on the medication list at the start of care”. 1b. Patient #6 was admitted on 9/21/23 with diagnoses of bilateral primary osteoarthritis of knee (joint disease), chronic pain syndrome, and bursitis (inflammation in the fluid filled sac) of left shoulder. The Plan of Care (POC) for 9/21/23-11/19/23 included orders for physical therapy 1 time a week for 5 weeks, occupational therapy 2 times a week for 1 week, 1 time a week for 4 weeks, and 1 time a week every 2 weeks for 2 weeks. A review of the start of care visit by the physical therapist for 9/21/23 revealed the DME (durable medical equipment) did not include oxygen. Interview with the physical therapist on 10/25/23 at 9:27 a.m. revealed, “with start of care’s it is equipment that they don’t have that we include on that section”. 2. Patient #9 was admitted on 9/26/23 with diagnoses of age related osteoporosis (weak bones) with fracture (break) of left femur, essential hypertension, and multiple sclerosis (an immune system disease). The Plan of Care (POC) for 9/26/23 -11/24/23 included orders for skilled nursing 1 time a week for 5 weeks. A home visit was conducted with the registered nurse on 10/24/23 at 11:00 a.m. A medication review was conducted and revealed the following discrepancy: -Lasix 40 mg (milligram) once a day by mouth taken for fluid retention was omitted from the plan of care. Interview with the patient/caregiver revealed she started taking the medication on 10/09/23.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on clinical record review and staff interviews the agency failed to follow the POC related to obtaining vital signs for 1 of 18 records reviewed (#13), failed to follow the POC related to suprapubic catheter (tube used to drain urine from the bladder through a cut in the abdomen) changes for 1 of 1 patients with a suprapubic catheter (#13). The findings included: 1a. Patient #13 was admitted on 5/13/23 with diagnoses of encounter and fitting for urinary device, encounter for attention to cystostomy (surgically created connection between the urinary bladder and skin), and neuromuscular dysfunction of the bladder. The Plan of Care (POC) for7/12/23-9/9/23 included orders for skilled nursing 1 week 1, 1 every 4 weeks 4 and 1 week 1. Orders for licensed professional to report vital signs falling outside the following established parameters: temperature less than 96 greater than 100, pulse less than 60 greater than 100, respirations less than 12 greater than 20, systolic (pressure caused by the heart contracting and pushing out blood) blood pressure less than 90, greater than 160, diastolic (pressure of circulating blood against the walls of the blood vessels) blood pressure less than 50 greater than 100, and pain greater than 7. Review of the skilled nursing note for 8/10/23 revealed no vital signs were obtained during the visit. Interview with the area vice president of operations on 10/25/23 at 1:51 p.m. confirmed no vital signs were in the record for the nursing visit on 8/10/23. 1b. Patient #13 was admitted on 5/13/23 with diagnoses of encounter and fitting for urinary device, encounter for attention to cystostomy (surgically created connection between the urinary bladder and skin), and neuromuscular dysfunction of the bladder. The Plan of Care (POC) for7/12/23-9/9/23 included orders for skilled nursing 1 week 1, 1 every 4 weeks 4 and 1 week 1. Skilled nursing order to change suprapubic catheter on 10/3/23 using a #18 FR (French) catheter and fill with 10cc (cubic centimeter) of water using aseptic technique (protection from germs). Review of skilled nursing note on 10/3/23 revealed the catheter was not changed on the ordered date and was changed on the next nursing visit of 10/5/23. Further documentation revealed the nurse used a #16 French catheter instead of the ordered #18 French catheter. Interview with the skilled nurse on 10/25/23 at 9:40 a.m. “No, that is what her caregiver used”, that’s correct I went back out the next morning to change the catheter, I didn’t have that size in my car stock, I used what I had”.

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 and procedure, clinical record review and staff interview the agency provided care without an order for 1 of 1 patients with a suprapubic catheter (#13). Findings included: The policy, “Physician Orders and Medical Supervision of the Plan of Care”, revised 6/22/23 was provided by the agency director on 10/25/23 at 12:00 p.m. The policy stated, "...drugs, services and treatments are administered only as ordered by a physician…” 1.Patient #13 was admitted on 5/13/23 with diagnoses of encounter and fitting for urinary device, encounter for attention to cystostomy (surgically created connection between the urinary bladder and skin), and neuromuscular dysfunction of the bladder. The Plan of Care (POC) for7/12/23-9/9/23 included orders for skilled nursing 1 week 1, 1 every 4 weeks 4 and 1 week 1. Skilled nursing order to change suprapubic catheter on 10/3/23 using a #18 FR (French) catheter and fill with 10cc (cubic centimeter) of water using aseptic technique (protection from germs). Review of the skilled nurse visit for 10/03/23 had documentation of instructing the caregiver to use triple antibiotic ointment on the catheter insertion cite due to redness. There was no evidence in the record of a physician’s order to use triple antibiotic ointment. Interview with Employee #5 on 10/25/23 at 9:40 a.m. “I did not call the doctor”.

Communication with all physicians CFR(s): 484.60(d)(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 agency policy and procedure, clinical record review, and staff interview the agency failed to coordinate care with the physician regarding a suprapubic catheter for 1 of 1 records reviewed with a suprapubic catheter (#13). Findings included: A policy, “Coordination of Care”, revised 05/04/2023 was received from the agency director on 10/25/23 at approximately 11:45 a.m. The policy stated…are notified promptly of 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…” 1.Patient #13 was admitted on 5/13/23 with diagnoses of encounter and fitting for urinary device, encounter for attention to cystostomy (surgically created connection between the urinary bladder and skin), and neuromuscular dysfunction of the bladder. The Plan of Care (POC) for7/12/23-9/9/23 included orders for skilled nursing 1 week 1, 1 every 4 weeks 4 and 1 week 1. Skilled nursing order to change suprapubic catheter on 10/3/23 using a #18 FR (French) catheter and fill with 10cc (cubic centimeter) of water using aseptic technique (protection from germs). Review of the skilled nursing visit note on 10/3/23 revealed the registered nurse did not change the catheter on 10/3/23 as ordered but changed it on 10/5/23. No documentation is in the record that the physician was notified of the catheter not being changed on 10/3/23 as ordered. Interview with Employee #5 on 10/25/23 at 9:40 a.m. “No, that is what her caregiver used”, that’s correct I went back out the next morning to change the catheter. I didn’t have that size in my car stock, I used what I had. no, I did not call the doctor”.

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 agency policy, direct observation and staff interviews clinicians failed to follow proper infection control guidelines for 2 of 6 home visits [#10 and 11]. The findings included: The policy, Bag Technique [6/20/23], was provided by the agency director on 10/24/23 at 3:30 pm. The policy stated, “…Always perform hygiene before entering bag…Keep the bag closed when not in use…” 1. Patient # 10 had a Start of Care date of 12/1/22 and an admitting diagnosis of other symptoms and signs with cognitive functions following cerebral infarction [stroke]. Review of the Plan of Care [POC] for the certification period 9/27/23 -11/25/23 included orders for PT [physical therapy] 1 time a week for 8 weeks. On 10/23/23 at approximately 1:30 pm a joint visit was made with PT # 4. During the visit, PT # 4 used hand sanitizer and removed vital sign equipment. He obtained vital signs and then went back into the bag without using sanitizer to obtain pulse oximeter. Also, the PT was noted to have left his bag unzipped for the entirety of the visit. During an interview with RN # 1 on 10/24/23 at approximately 3:30 pm, RN # 1 confirmed the bag should have been closed when not in use. The RN also confirmed hand hygiene should be completed before entering the bag. 2. Patient # 11 had a Start of Care date of 10/5/23 and an admitting diagnosis of pneumonia. Review of the Plan of Care [POC] for the certification period 10/5/23-12/3/23 included orders for PT [physical therapy] 1 time a week for 5 weeks and 1 time every 2 weeks for 4 weeks. A home visit was conducted with PTA [physical therapy assistant] # 8 on 10/24/23 at approximately 10:30 am. Upon entry to the patient’s home, PTA # ‘s nursing bag was noted to be unzipped. The bag remained unzipped throughout the visit with the PTA entering the bag several times to take items out and return items to the bag. During an interview with RN # 1 on 10/24/23 at approximately 3:30 pm, RN # 1 confirmed the nursing bag should have been closed when not in use.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on agency policy, clinical record review and staff interviews the agency failed to provide care in accordance with The Condition Skilled Professional Service for 3 of 18 patient [5, 1 and 14]. Cross refer to §484.75(b) G0704 §484.75(b)(6) G0716

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on clinical record review and staff interviews the Registered Nurse [RN] failed to follow up with the physician for wound care orders for 1 of 1 patient who underwent partial amputation of left great toe [#5]. Immediate Jeopardy was identified beginning 5/16/23 and abated at 3:34 pm on 10/25/23. The findings included: Patient # 5 had a Start of Care [SOC] date of 3/31/23 and admitting diagnoses of type 2 diabetes mellitus with hyperglycemia, type 2 diabetes with diabetic autonomic neuropathy [damage to nerves that control the internal organs], type 2 diabetes mellitus with diabetic polyneuropathy [progressive death of nerve fibers, which leads to loss of nerves, increased sensitivity, and the development of foot ulcers] and type 2 diabetes with diabetic peripheral angiopathy without gangrene [ narrowing in the arteries which results in an undersupply of blood and oxygen to different organs and can lead to damage in the long term]. Review of the Plan of Care for the certification period 3/31/23-5/29/23 included orders for PT [physical therapy] 1 time a week for 5 weeks, 1 time a week every 2 weeks for 2 weeks, 1 time a week for 2 weeks and OT [occupational therapy] 1 time a week for 1 week. Patient # 5 was hospitalized from 4/13/23-4/15/23 with a diagnosis of acute metabolic encephalopathy [condition caused when elevated blood sugar causes confusion and possibly coma]. Review of the clinical record revealed PT [physical therapy] # 3 completed the Resumption of Care [ROC-comprehensive assessment completed after an inpatient stay] visit on 4/26/23. The ROC orders included PT [physical therapy] 1 time a week for 5 weeks. The comprehensive assessment on 4/26/23 did not identify any wounds. Review of the clinical record revealed PTA [physical therapy assistant] # 8 conducted a routine visit on 5/16/23 [Tuesday] and documented the following information, “…New incision/wound/skin tear not currently included on the patient’s plan of care…Patient has open wound on Left great toe…” An order dated 5/17/23 for “SN [skilled nurse] to eval [evaluate] for wound on left great toe week of 5/17/23. Spoke with Dr. _____ [name] office.” RN # 9 conducted a visit on 5/19/23 [Friday] and documented, “Patient seen today for evaluation of left great toe. Patient unsure how she received wound but thinks she hit something by accident…No orders at this time but patient will see PCP [primary care physician] on Monday [5/22/23].” RN # 9 documented the wound was “2 cm x 1 cm x 1 cm... Awaiting orders for left great toe…” There was no evidence RN # 9 notified the physician of the assessment results made by the RN. Review of the clinical record revealed a physician’s order dated 5/25/23 that stated, “Discharge from nursing services until patient sees physician.” Further review of the clinical record revealed a progress note dated 5/26/23 from _______ PA [physician’s assistant]. The note stated, “…presents complaining of left great toe distal tip wound x 6 weeks. Sustained during a fall…requesting home health wound care…Agree with home health wound care…” There was no evidence the nurse followed up with the physician after the patient saw the physician on 5/26/23 regarding any wound care orders. The clinical record revealed no further documentation regarding the wound to left great toe. On 6/14/23, the patient was admitted to _______ [name of hospital] with a diagnosis of diabetic foot infection and underwent partial amputation of the left great toe. During an interview with RN # 9 on 10/24/23 at approximately 10 am, the RN stated, “I can’t remember anything about that patient.” During an interview with RN # 10 on 10/25/23 at approximately 12 noon, the RN stated, “The patient had a doctor’s appointment on that Monday but didn’t have transportation. We [the agency] arranged for her to get transportation to the doctor’s office on Friday the 26th. May 26, 2023, would have been the first time the physician saw the wound. I believe we did all we could do for this patient. We went above and beyond. We would have had no reason to reach out to the physician’s office after the visit.” I believe we did all we could do for this patient. We went above and beyond. We would have had no reason to reach out to the physician’s office after the visit.” Credible Allegation of Compliance The plan of correcting the specific deficiency. The plan should address the processes that lead to the deficiency cited. On 10/23/23, an onsite, recertification survey was initiated. It was identified and discussed with agency/regional leadership on 10/24/23 that a PTA had identified breakdown to patient’s left great toe during visit on 5/16/23. Patient had admitting diagnosis of Type 2 Diabetes with Hyperglycemia and Type 2 Diabetes with Diabetic Polyneuropathy. An RN evaluation was performed on 5/19/23 and documented the following information about the wound to the left toe “Patient seen today for evaluation of left great toe. Patient unsure how she received the wound but thinks she may have hit something by accident. No orders at this time [for wound care] but patient will see PCP on Monday.” The wound measurements were 2 cm x 1 cm x 1 cm. The RN failed to notify the physician to obtain orders related to the wound. No more SN visits were made to see the patient. Review of the medical record revealed the patient was seen in the MD office on 5/26/23 after the RN assessed the patient on 5/19/23. The md indicated home health was changing the dressing to the left toe 2 times per week. However, no order was noted for wound care to be done by the agency. The RN did not see the patient after the visit on 5/19/23 and did not follow up with the physician for any type of orders. The patient was admitted to the hospital on 6/14/23 with a diagnosis of Osteomyelitis of left foot and underwent amputation of left hallux. The procedure for implementing the acceptable plan of correction for the specific deficiency cited; Immediately, 100% review of all current wound patients reviewed by corporate Assistant VP Wound Care and Directors of Operations: Immediately, wound care education provided 10/25/23 to clinicians by corporate Assistant VP Wound Care including reporting findings/changes in wound status/new wounds to physician and documenting in medical record all correspondence with physician related to wounds. The monitoring procedure to ensure that the plan of correction is effective, and that specific deficiency cited remains corrected and/or in compliance with the regulatory requirements; DOO/Designee will audit 100% of all active wound care charts to ensure the physician was notified of any change in the patient condition. Audits will continue until 95% compliance is reached and maintained for 3 consecutive weeks. Audits will then be decreased to 50% of all active wound care charts and will continue until compliance is maintained at 95% for 2 additional consecutive weeks then will decrease to 10 charts per quarter during utilization review. If compliance is not met or maintained at 95% compliance, re-education and remediation will be performed as needed. The HR disciplinary process will be implemented as necessary based on trends of non-compliance. The AVP of Wound Care Excellence and/Wound Care Director can be accessed for wound consultation and PCC involvement. The title of the person responsible for implementing the acceptable plan of correction. Administrator

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on agency policy, clinical record review and staff interviews the OT [occupational therapist] and PT [physical therapy] failed to document accurately related to skin breakdown/presence of nonremovable dressing for 3 of 18 patients [#1, 5 and 14]. The findings included The policy, Clinical Record Contents [9/1/23], was provided by the agency director on 19/24/23 at 3 pm. The policy stated, “…Information in the clinical record must be accurate…” 1. Patient # 1 had a Start of Care [SOC] date of 5/22/23 and admission diagnoses of cirrhosis of liver [type of liver damage where healthy cells are replaced by scar tissue and diabetes mellitus. Review of the Plan of Care for the certification period 5/22/23 to 7/20/23 included orders for SN [skilled nursing] 1 time a week for 3 weeks, 1 time a week every 2 weeks for 6 weeks; PT [physical therapy] 2 times a week for 3 weeks, 1 time a week for 6 weeks; OT [occupational therapy] 1 time a week for 5 weeks. The patient was admitted to the hospital on 5/26/23 with a diagnosis of hypoglycemia [low blood sugar]. The following supplemental orders were written following the Resumption of Care [ROC- comprehensive assessment completed after inpatient stay]:6/18/23-PT 1 time a week for 1 week; 6/25/23 OT 1 time a week for 4 weeks. On 6/28/23, OT # 7 completed the OT evaluation. Review of the OT evaluation revealed the following information was documented under the Integumentary Section of the visit note “New incision/wound/skin tear not currently included on the patient’s plan of care”. Review of the clinical record revealed COTA [occupational assistant] # 12 conducted a routine visit on 7/3/23 and documented the following information under the integumentary section “Incision/wound/skin tear with care currently included on the patient’s plan of care by another discipline.” Further review of the clinical record revealed no evidence the patient had any type of wound. During an interview with RN # 1 on 10/26/23 at approximately 1:30 pm, RN # 1 confirmed the patient did not have any wounds. 2. Patient # 5 had a Start of Care [SOC] date of 3/31/23 and admitting diagnoses of type 2 diabetes mellitus with hyperglycemia, type 2 diabetes with diabetic autonomic neuropathy [damage to nerves that control the internal organs], type 2 diabetes mellitus with diabetic polyneuropathy [progressive death of nerve fibers, which leads to loss of nerves, increased sensitivity, and the development of foot ulcers] and type 2 diabetes with diabetic peripheral angiopathy without gangrene [ narrowing in the arteries which results in an undersupply of blood and oxygen to different organs and can lead to damage in the long term]. There was a Resumption of Care [ROC-comprehensive assessment completed after an inpatient stay] conducted on 4/26/23. Review of the ROC orders revealed an order for OT [occupational therapy] to evaluate the week of 4/40/23. Review of the clinical record revealed OT # 7 conducted the OT evaluation visit on 5/1/23. Review of OT # 7’s documentation indicated the patient had skin tears. No other documentation related to the integumentary system was documented. During an interview with OT # 7 on 10/25/23 at 9 am, the OT stated, “I don’t recall anything about any skin tears.” 3. Patient # 14 had a Start of Care [SOC] date of 10/2/23 and admitting diagnoses of encounter for other orthopedic aftercare and radiculopathy [injury or damage to nerve roots in the area where they leave the spine]. Review of the Plan of Care [POC] for the certification period 10/2/23-11/30/23 revealed orders for PT [physical therapy] 3 times a week for 1 week, 2 times a week for 1 week, 1 time a week for 7 weeks. Review of the clinical record revealed PT # 4 completed the SOC visit on 10/2/23. Review of the SOC documentation revealed PT # 4 indicated the patient had a non-removable dressing. Review of the Orthopedic Discharge Summary dated 9/21/23 revealed the following documentation,” …The patient has a [sic] aquacel dressing in place and can be removed in 7 days [9/28/23].” The patient was not admitted to the agency until 10/2/23. During an interview with RN # 2 on 10/25/23 at approximately 1 pm, RN # 2 confirmed the clinical record was not accurate when stating the patient had a non-removable dressing in place.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on agency policy, clinical record review and staff interviews the agency failed to complete/provide physician with a transfer summary for 3 of 4 patients who were transferred/admitted to the hospital [#1, 5 and 8]. The findings included: The policy, Transfer of Patients [1/23/23], was provided by the area vice president on 10/25/23 at 12:33 pm. The policy stated, “…Completed transfer summary is sent within 2 business days of becoming aware of an unplanned transfer…A copy of the summary is placed in the clinical record…” 1. Patient # 1 had a Start of Care [SOC] date of 5/22/23 and admission diagnoses of cirrhosis of liver [type of liver damage where healthy cells are replaced by scar tissue and diabetes mellitus. Review of the Plan of Care for the certification period 5/22/23 to 7/20/23 included orders for SN [skilled nursing] 1 time a week for 3 weeks, 1 time a week every 2 weeks for 6 weeks; PT [physical therapy] 2 times a week for 3 weeks, 1 time a week for 6 weeks; OT [occupational therapy] 1 time a week for 5 weeks. Review of the clinical record revealed the patient was transferred and admitted to the hospital on 5/26/23 for hypoglycemia [low blood sugar]. Further review of the clinical record revealed no transfer summary was completed and sent to the physician. During an interview with RN # 10 on 10/25/23 at approximately 2 pm, the RN confirmed no transfer summary was completed. 2. Patient # 5 had a Start of Care date of 3/31/23 with admitting diagnoses of type 2 diabetes mellitus with hyperglycemia [elevated blood sugar], type 2 diabetes with diabetic autonomic neuropathy [damage to nerves that control the internal organs], type 2 diabetes mellitus with diabetic polyneuropathy [progressive death of nerve fibers, which leads to loss of nerves, increased sensitivity, and the development of foot ulcers] and type 2 diabetes with diabetic peripheral angiopathy without gangrene [ narrowing in the arteries which results in an undersupply of blood and oxygen to different organs and can lead to damage in the long term]. Review of the clinical record revealed Patient # 5 was transferred and admitted to an inpatient setting [hospital] on 4/13/23. Further review of the clinical record revealed no evidence a transfer summary was completed and sent to the physician. During an interview with RN # 10 on 10/25/23 at approximately 2 pm, RN # 10 confirmed no transfer summary was completed. 3. Patient # 8 had a Start of Care date of 9/7/23 and admitting diagnosis of ataxia [lack of coordination] following cerebral infarction [stroke]. Review of the Plan of Care for the certification period 9/7/23-11/5/23 included orders for PT [physical therapy] 1 time a week for 1 week, 2 times a week for 1 week, 1 time a week for 3 weeks, 1 time a week every other 2 weeks for 4 weeks. Review of the clinical record revealed a transfer OASIS [Outcome and Assessment Information Set-a group of standard date elements included in comprehensive assessments] was completed on 10/18/23. The transfer OASIS indicated the patient was admitted to the hospital on 10/16/23. Further review of the clinical record revealed no evidence a transfer summary was completed and sent to the physician. During an interview with RN # 10 on 10/25/23 at approximately 2 pm, RN # 10 confirmed no transfer summary was completed.

An onsite unannounced recertification survey was conducted 8/16/21-8/19/21. No deficiencies to the Emergency Preparedness Plan was identified.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and staff interviews the agency failed to document the existence of a complaint for 1 of 5 discharged charts reviewed [#22]. The findings included: The policy, Patient/Caregiver Grievance/Complaint Policy [review date of 6/24/21], was presented by RN # 16 on 8/19/21. The policy stated, “…The agency is to initiate a complaint investigation within 10 business days of the agency’s receipt of the complaint and document all components of the investigation. Documentation of the complaint is completed by the employee to whom the complaint is received and forwarded to the agency that includes the following: Date of the complaint, Person filing the complaint, Person involved in complaint, Person lodging complaint…” Patient # 22 had a Start of Care [SOC] date of 12/22/21 and an admitting diagnosis of COVID-19. A review of the Plan of Care [POC] for the certification period 12/22/21 to 2/19/21 revealed orders for SN [skilled nursing] 1 time a week for 1 week; 2 times a week for 2 weeks; 1 time a week for 6 weeks. A review of the clinical record revealed the following information: On 12/22/21 RN # 14 completed the admission assessment. The next visit was on 1/15/21 [the patient had reported missed visits up until this point]. The patient was admitted to the hospital on 1/19/21 for severe hip pain. When RN # 1 contacted the patient on 1/25/21 the RN documented the following, “Called patient to follow up on her decision to change to another hh [home health] …Patient stated that we didn’t know what we were doing…I apologized to her…I assured her the previous problems wouldn’t be repeated…” A review of the complaint log revealed no information related to this concern was documented. RN # 1 or RN # 14 are employed with the agency any longer. An interview was conducted with RN # 16 on 8/19/21 at approximately 11 am. During the interview the RN confirmed this issue should have been logged in the complaint log.

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 agency policy review, clinical record review and staff interviews the Plan of Care [POC] failed to include all current/correct medications the patient is using for 2 of 24 charts reviewed [#6 and 18]; failed to include blood sugar parameters on the Plan of Care [POC] for 7 of 24 charts [#6, 1, 2, 5, 9, 19, 23]. The findings included: The policy, Physician Orders and Medical Supervision of the Plan of Care [review date of 4/29/21] was provided by RN # 16 on 8/19/21. The policy stated, "...The current 485 will include...medications and treatments..." 1A. Patient # 6 had a Start of Care [SOC] date of 7/27/21 and admitting diagnoses of type 2 diabetes mellitus with other skin ulcer and dependence on supplemental oxygen. A review of the Plan of Care [POC] for the certification period 7/27/21 to 9/24/21 revealed orders for SN [skilled nursing] 2 times a week for 4 weeks; 1 time a week for 5 weeks. A review of the POC revealed oxygen was not included on the medication profile. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15. During the interview RN # 15 confirmed the patient did use supplemental oxygen in the home and the oxygen was not included on the medication profile on the POC. 1B. Patient # 6 had a Start of Care [SOC] date of 7/27/21 and an admitting diagnosis of type 2 diabetes mellitus with other skin ulcer. A review of the Plan of Care [POC] for the certification period 7/27/21 to 9/24/21 revealed orders for SN [skilled nursing] 2 times a week for 4 weeks; 1 time a week for 5 weeks. A review of the safety measures on the POC included “Diabetic Precautions”. Further review of the POC revealed the POC did not include blood sugar parameters. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15. RN # 15 confirmed the POC should have included blood sugar parameters. 2. Patient # 18 had a Start of Care [SOC] date of 7/22/21 and an admitting diagnosis of chronic respiratory failure with hypoxia. A review of the Plan of Care for the certification period 7/22/21 to 9/19/21 revealed orders for PT [physical therapy] 1 time a week for 2 weeks; 2 times a week for 1 week; 1 time a week for 2 weeks; 1 time every 2 weeks for 4 weeks, OT [occupational therapy] 2 times a week for 1 week; 1 time a week for 2 weeks; 1 time every 2 weeks for 4 weeks; 1 time a week for 1 week. A review of the clinical record revealed PT # 3 completed the start of care assessment on 7/22/21 and noted the patient used supplemental oxygen. PTA # 17 made routine visits on 7/30/21 and 8/6/21 and documented Patient # 18 used supplemental oxygen at 2 liters per minute. On 8/13/21 OT # 5 documented the patient had supplemental oxygen in place. A review of the POC revealed oxygen was not listed in the medication section of the POC. An interview was conducted with RN # 15 on 8/19/21 at approximately 9:30 am. During the interview the RN confirmed oxygen is considered a medication and should have been listed on the POC. 3. Patient # 1 had a Start of Care [SOC] date of 6/29/21 and admitting diagnoses of disruption of external operation wound, type 2 diabetes mellitus with diabetic polyneuropathy and type 2 diabetes mellitus with other specified complication. A review of the Plan of Care for the certification period 6/29/21 to 8/27/21 revealed orders for SN [skilled nursing] 2 times a week for 1 week; 3 times a week for 7 weeks and 2 times a week for 1 week. Further review of the Plan of Care revealed safety measures to included “diabetic precautions”. Further review of the POC revealed no blood sugar parameters were included on the POC. An interview was conducted with RN # 15 on 8/19/21 at approximately 9:30 am. During the interview RN stated, “the plan of care should include blood sugar parameters.” 4. Patient # 2 had a Start of Care [SOC] date of 7/12/21 and an admitting diagnosis of other specified diabetes mellitus with foot ulcer. A review of the Plan of Care [POC] for the certification period 7/12/21 to 9/9/21 revealed orders for SN [skilled nursing] 2 times a week for 2 weeks; 1 time a week for 7 weeks and “Diabetic Precautions”. A review of the Plan of Care revealed no blood sugar parameters. On 8/19/21 at approximately 9:30 am. an interview was conducted with RN # 15. During the interview RN # 15 confirmed the POC should include blood sugar parameters. 5. Patient # 5 had a Start of Care [SOC] date of 7/22/21 and admitting diagnoses of hypertensive heart disease without heart failure and type 2 diabetes mellitus with hyperglycemia. A review of the Plan of Care for the certification period 7/1/21 to 8/29/21 revealed orders for SN [skilled nursing] 1 time a week for 5 weeks; “skilled nurse for instructions of diabetic care to include: …signs and symptoms of hypo/hyperglycemia…skilled nurse to report to physician blood glucose readings greater than or less than [no parameters included in the order] …” On 8/19/21 an interview was conducted with RN # 15. During the interview the RN confirmed the POC failed to include blood sugar parameters. 6. Patient # 9 had a Start of Care [SOC] date of 7/8/21 and an admitting diagnosis of type 2 diabetes mellitus with foot ulcer. A review of the Plan of Care [POC] for the certification period 7/8/21 to 9/8/21 revealed orders for SN [skilled nursing] 1 time a week for 5 weeks; 1 time every 4 weeks for 4 weeks and “Diabetic Precautions”. Further review of the Plan of Care revealed no blood sugar parameters. An interview was conducted with RN # 15 on 8/19/21 at approximately 9:30 am. During the interview RN confirmed blood sugar parameters should have been included on the POC. 7. Patient # 19 had a Start of Care [SOC] date of 4/30/21 and admitting diagnoses of pressure ulcer of sacral region, stage 3, type 2 diabetes with diabetic peripheral angiopath without gangrene, type 2 diabetes mellitus with diabetic polyneuropathy and type 2 diabetes mellitus with other circulatory complications. A review of the Plan of Care for the certification period 6/26/21 to 8/27/21 revealed orders for SN [skilled nursing] 1 time a week for 9 weeks and “Diabetic Precautions”. Further review of the POC revealed no blood sugar parameters. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15. The RN confirmed the POC should have included blood sugar parameters. 8. Patient # 23 had a Start of Care [SOC] date of 5/14/21 and admitting diagnoses of type 1 diabetes mellitus with hyperglycemia and type 1 diabetes mellitus with foot ulcer. A review of the Plan of Care for the certification period 5/14/21 to 7/12/21 revealed orders for SN [skilled nursing] 1 time a week for 1 week; 3 times a week for 8 weeks; 1 time a week for 1 week. Further review of the POC revealed, "Diabetic Precautions" and "SN for instructions of diabetic care to include: …signs and symptoms of hypo/hyperglycemia...blood glucose testing..." The POC did not include blood sugar parameters. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15. During the interview RN # 15 confirmed blood sugar parameters should have been included on the POC.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on clinical record review and staff interviews the agency failed to follow the Plan of Care related to wound care orders for 2 of 13 records reviewed [#1 and 6]; failed to follow the POC related to suprapubic catheter changes for 1 of 1 patient with a suprapubic catheter [#9]; failed to obtain a full set of vital signs for 2 of 24 charts [#15 and 19]. The findings included: 1. Patient # 1 had a Start of Care [SOC] date of 6/29/21 and admitting diagnoses of disruption of external operation wound, type 2 diabetes mellitus with diabetic polyneuropathy and type 2 diabetes mellitus with other specified complication. A review of the Plan of Care for the certification period 6/29/21 to 8/27/21 revealed orders for SN [skilled nursing] 2 times a week for 1 week; 3 times a week for 7 weeks and 2 times a week for 1 week. Further review of the clinical record revealed the patient was hospitalized from 7/5/21 until 7/9/21. A resumption of care visit was done on 7/10/21. A review of the resumption of care orders revealed new orders for SN 1 time a week for 1 week and 3 times a week for 7 weeks and, “SN to apply NPWT [negative pressure wound therapy] to right heel at 125 mm hg continuous suction…cleanse with NS [normal saline] …in the event of a malfunction of the device, complications maintaining a seal…cleanse the wound with wound cleanser and apply a NS [normal saline] moistened gauze dressing…” A review of the clinical record revealed RN # 4 made a routine visit on 7/19/21 and documented the following information, “SN attempted to apply vac unable to get seal; due to no supplies betadine abd [abdominal] applied.” Further review of the clinical record revealed RN # 4 made a routine visit on 7/21/21 and documented the following information, “Wound cleansed with NS [normal saline] and Dakin’s…” An interview was conducted with RN # 4 on 8/19/21 at approximately 1 pm. During the interview, RN # 4 confirmed she did not follow the POC related to the type of dressing she applied during the visit on 7/19/21 or the cleaning solution during the visit on 7/21/21. 2. Patient # 6 had a Start of Care [SOC] date of 7/27/21 and an admitting diagnosis of type 2 diabetes mellitus with other skin ulcer. A review of the Plan of Care [POC] for the certification period 7/27/21 to 9/24/21 revealed orders for SN [skilled nursing] 2 times a week for 4 weeks; 1 time a week for 5 weeks and “SN to perform/teach diabetic ulcer…care to irrigate/cleanse WC [wound cleanser] …apply aquacel ag…wrap from base of toes to below the knee…change dressing 2 times per week…” A review of the clinical record revealed the following documentation on 8/3/21 by RN # 4, “…Old dressing removed, due to lack of supplies wound was cleaned with betadine and dressed with kerlix…” On 8/19/21 at approximately 1 pm an interview was conducted with RN # 4. During the interview the RN confirmed she did not follow the POC related to the wound care and did not notify the physician to obtain an order for the wound care she performed during the visit. 3. Patient # 9 had a Start of Care [SOC] date of 7/8/21 and an admitting diagnosis of type 2 diabetes mellitus with foot ulcer. A review of the Plan of Care [POC] for the certification period 7/8/21 to 9/8/21 revealed orders for SN [skilled nursing] 1 time a week for 5 weeks; 1 time every 4 weeks for 4 weeks and “…skilled nurse to perform insertion of 16 French indwelling catheter, instill 10 cc of NS [normal saline] into the balloon…change every 4 weeks and PRN for leakage, blockage, dislodgement or malfunction.” A review of the clinical record revealed RN # 9 made routine visits on 8/6/21, 8/12/21 and 8/13/21. A review of the clinical record revealed the following documentation, “8/6/21-cathether leaks profusely. MD aware…8/12/21-patient’s cath [catheter] has been leaking worse than ever…8/13/21-leaking catheter.” RN # 7 made a routine visit on 8/9/21 and documented the patient had a “leaking catheter.” Further review of the clinical record revealed neither RN contacted the MD to report the leaking catheter or made a PRN visit to change the catheter. An interview was conducted with RN # 15 on 8/19/21 at approximately 9:30 am. During the interview RN confirmed a PRN should have been made to change the suprapubic catheter in accordance with the POC. 4. Patient # 15 had a Start of Care [SOC] date of 3/31/21 and an admitting diagnosis of pressure ulcer of right buttock, stage 3. A review of the Plan of Care [POC] for the certification period 7/29/21 to 9/26/21 revealed orders for OT [occupational therapy] 1 time a week for 5 weeks and “licensed professional to report vital signs falling outside the following established parameters temp less than 96 or greater than 100, pulse less than 60 or greater than 100, respiratory rate less than 12 or greater than 20, systolic bp less than 90 or greater than 180, diastolic blood pressure less than 50 or greater than 100.” A review of the clinical record revealed employee # 6 made routine visits on 7/29/21, 8/3/21 and 8/17/21. During the visit on 7/29/21 employee # 6 failed to obtain a temperature and respirations. During the visit on 8/3/21 employee # 6 failed to obtain a blood pressure or a temperature. During the 8/17/21 visit the employee failed to obtain a temperature. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15. During the interview RN # 15 confirmed all employees are expected to obtain a full set of vital signs at each visit. 5. Patient # 19 had a Start of Care [SOC] date of 4/30/21 and an admitting diagnosis of pressure ulcer of sacral region, stage 3. A review of the Plan of Care for the certification period 6/26/21 to 8/27/21 revealed orders for OT [occupational therapy] 1 time a week for 1 week; 1 time every 3 weeks for 3 weeks and “licensed professional to report vital signs falling outside the following established parameters temp less than 96 or greater than 100, pulse less than 60 or greater than 100, respiratory rate less than 12 or greater than 20, systolic bp less than 90 or greater than 180, diastolic blood pressure less than 50 or greater than 100.” A review of the clinical record revealed OT # 6 made a routine visit on 7/8/21. Further review of the clinical record revealed no temperature was obtained during the 7/15/21 visit. An interview was conducted with RN # 15 on 8/19/21 at approximately 9:30 am. During the interview the RN confirmed a full set of vital signs is expected each visit by each discipline in conformance with the POC.

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 clinical record review and staff interviews the agency failed to obtain orders for wound care for 1 of 13 charts [#1]; failed to obtain an order to flush a Foley catheter for 1 of 1 patient with a Foley catheter [#9]. The findings included: 1. Patient # 1 had a Start of Care [SOC] date of 6/29/21 and admitting diagnoses of disruption of external operation wound, type 2 diabetes mellitus with diabetic polyneuropathy and type 2 diabetes mellitus with other specified complication. A review of the Plan of Care for the certification period 6/29/21 to 8/27/21 revealed orders for SN [skilled nursing] 2 times a week for 1 week; 3 times a week for 7 weeks and 2 times a week for 1 week. Further review of the clinical record revealed the patient was hospitalized from 7/5/21 until 7/9/21. A resumption of care visit was done on 7/10/21. A review of the resumption of care orders revealed new orders for SN 1 time a week for 1 week and 3 times a week for 7 weeks. A review of the clinical record revealed a routine visit was made on 8/9/21 by RN # 9. RN # 9 documented the following information, “..patient has 2 wounds now…mid edge of right foot…alginate applied…right heel…wet to dry applied…called md office…office closed…will call tomorrow…” There is no evidence the MD was notified for the orders. RN # 9 was no longer employed with the agency. An interview was conducted with RN # 15 on 8/19/21. During the interview RN # 15 confirmed there was no evidence the MD was notified for the orders. 2. Patient # 9 had a Start of Care [SOC] date of 7/8/21 and an admitting diagnosis of type 2 diabetes mellitus with foot ulcer. A review of the Plan of Care [POC] for the certification period 7/8/21 to 9/8/21 revealed orders for SN [skilled nursing] 1 time a week for 5 weeks; 1 time every 4 weeks for 4 weeks and “…skilled nurse to perform insertion of 16 French indwelling catheter, instill 10 cc of NS [normal saline] into the balloon…change every 4 weeks and PRN for leakage, blockage, dislodgement or malfunction.” A review of the clinical record revealed RN # 9 made a routine visit on 8/12/21 and documented the following, “…patient’s catheter has been leaking worse than ever…flushed and added water to bulb…” A review of the POC revealed no order for the SN to flush the catheter. RN # 9 is no longer employed with the agency. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15. During the interview RN # 15 confirmed there was no order on the POC for the SN to flush the catheter or add water to the bulb.

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 agency policy review, clinical record review and staff interviews the agency failed to notify the MD of the deterioration of a wound for 1 of 2 patients with NPWT [negative pressure wound therapy] [#1]. The findings included: The policy, Coordination of Care [revised date of 4/2019], was provided by RN # 16 on 8/19/21. The policy stated, "...physicians are notified promptly of any changes in the patient's condition or needs that suggest than [sic] outcomes are not being achieved and or that the plan of care should be altered..." Patient # 1 had a Start of Care [SOC] date of 6/29/21 and admitting diagnoses of disruption of external operation wound, type 2 diabetes mellitus with diabetic polyneuropathy and type 2 diabetes mellitus with other specified complication. A review of the Plan of Care for the certification period 6/29/21 to 8/27/21 revealed orders for SN [skilled nursing] 2 times a week for 1 week; 3 times a week for 7 weeks and 2 times a week for 1 week. Further review of the clinical record revealed the patient was hospitalized from 7/5/21 until 7/9/21. A resumption of care visit was done on 7/10/21. A review of the resumption of care orders revealed new orders for SN 1 time a week for 1 week and 3 times a week for 7 weeks and, “SN to apply NPWT [negative pressure wound therapy] to right heel at 125 mm hg continuous suction…cleanse with NS [normal saline] …in the event of a malfunction of the device, complications maintaining a seal…cleanse the wound with wound cleanser and apply a NS [normal saline] moistened gauze dressing. RN # 9 made a routine visit on 8/11/21 and documented the following, “… wound vac removed. There are various stitches hanging…looks like hamburger meat…wound macerated. Reapplied vac. Attempted to call MD office. Office closed.” There is no evidence the RN notified a physician of her findings until the following week. RN # 9 was no longer employed by the agency. An interview was conducted with RN # 15 on 8/19/21 at approximately 9:30 am. During the interview RN # 15 confirmed the physician was not notified of the nurse's findings.

Communication with all physicians CFR(s): 484.60(d)(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 clinical record review and staff interviews the agency failed to coordinate care with the MD related to medications and dressing orders for 2 of 24 charts [#5 and 20]. The findings included: 1. Patient # 5 had a Start of Care [SOC] date of 7/22/21 and admitting diagnoses of hypertensive heart disease without heart failure and type 2 diabetes mellitus with hyperglycemia. A review of the Plan of Care for the certification period 7/1/21 to 8/29/21 revealed orders for SN [skilled nursing] 1 time a week for 5 weeks. A review of the clinical record revealed the start of care assessment was completed on 7/1/21 by RN # 4. Further review of the start of care assessment revealed the following documentation on 7/1/21 by RN # 4, “…patient states she only takes Metformin [diabetic medication] once a day. Advised patient medication was ordered two times per day and she should talk to the md office if needing to change the dose…” On 8/19/21 at approximately 1 pm an interview was conducted with RN # 4 . During the interview the RN reported she failed to notify the physician the patient was not taking Metformin as ordered. 2. Patient # 20 had a Start of Care [SOC] date of 11/25/20 and an admitting diagnosis of encounter for change or removal of nonsurg wound dressing. A review of the Plan of Care [POC] for the certification period 11/25/20 to 1/23/21 revealed orders for SN [skilled nursing] 1 time a week for 2 weeks; 2 times a week for 7 weeks and “skilled nurse to perform…wound care to top of right foot…irrigate /cleanse with NS [normal saline] or wound cleanser, apply medihoney, may apply skin barrier…cover with gauze…change dressing every day and prn…” Further review of the clinical record revealed the hospital discharge instructions called for, “caradress gel sheet”. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15 . During the interview RN # 15 confirmed there was no communication with the physician related to using medihoney instead of the caradress gel as ordered.

Other pertinent instructions CFR(s): 484.60(e)(4) Any other pertinent instruction related to the patient's care and treatments that the HHA will provide, specific to the patient's care needs. This ELEMENT is not met as evidenced by: Based on clinical record and staff interviews the agency failed to give the patient correct information related to frequency of dressing changes for 1 of 24 charts [#9]. The findings included: Patient # 9 had a Start of Care [SOC] date of 7/8/21 and an admitting diagnosis of type 2 diabetes mellitus with foot ulcer. A review of the Plan of Care [POC] for the certification period 7/8/21 to 9/8/21 revealed orders for SN [skilled nursing] 1 time a week for 5 weeks; 1 time every 4 weeks for 4 weeks and “Skilled nurse to perform/teach incision care to right foot area…apply betadine…cover with kerlix…home health SN to change dressing once weekly and PRN [as needed] for dislodgement or soiling.” A review of the clinical record revealed RN # made a routine visit on 7/12/21. During the visit RN #9 made a note that stated, “…contacted MD office and per Medicare guidelines betadine and a wrap can only be performed once weekly by home health and patient will have to do on other days.” RN # 9 is no longer employed with the agency. On 8/19/21 at approximately 11 am an interview was conducted with RN # 16. During the interview RN confirmed this was incorrect information.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and staff interviews the agency failed to document wound measurements in accordance with agency policy for 2 of 13 patients [#19 and 23]. the findings included: The policy, The Provision of Wound and Skin Care [revised date of 2/25/21] was provided by RN # 16 on 8/19/21. The policy stated, "...In accordance with best practice and standard of care, wounds will be measured a minimum of one time a week..." 1. Patient # 19 had a Start of Care [SOC] date of 4/30/21 and an admitting diagnosis of pressure ulcer of sacral region, stage 3. A review of the Plan of Care for the certification period 6/26/21 to 8/27/21 revealed orders for SN [skilled nursing] 1 time a week for 9 weeks and “skilled nurse to perform…pressure ulcer care to sacrum, cleanse wound with wound cleanser pat dry with 4x4…pack wound with 0.025% dakins soaked kerlix…change dressing twice daily…” A review of the clinical record revealed no documented wound measurements from 6/29/21-8/17/21. On 8/19/21 at approximately 9:30 am an interview was conducted with RN # 15 . During the interview RN confirmed no wound measurements were documented. 2. Patient # 23 had a Start of Care [SOC] date of 5/14/21 and admitting diagnoses of type 1 diabetes mellitus with hyperglycemia and type 1 diabetes mellitus with foot ulcer. A review of the Plan of Care for the certification period 5/14/21 to 7/12/21 revealed orders for SN [skilled nursing] 1 time a week for 1 week; 3 times a week for 8 weeks; 1 time a week for 1 week and "skilled nurse to perform/teach patient/caregiver wound care to right lower extremity, right leg apply xeroform and kerlix every 3 days; heel-apply barrier cream, dampen gauze with dakins, pack into wound bed, cover with abd pad and kerlix BID [2 times per day] 3 times per week..." A review of the clinical record revealed RN # 1 completed the admission assessment. RN # 1 documented the following information, "...Patient has wounds...recent hospitalization for...osteomyelitis..." Further review of the clinical record revealed no wound assessment or measurements. RN # 1 is no longer employed with the agency. On 8/19/21 at 9:30 am an interview was conducted with RN # 15. During the interview RN # 15 confirmed the wound assessment was not included in the clinical record.