Every finding on record at Amedisys North Carolina , LLC

An onsite, unannounced complaint investigation was conducted 06/18/24. Deficiencies to the Medicare Conditions of Participation were identified.

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, clinical record review, and staff interviews the agency failed to alert the relevant physician of changes in the patient’s condition that suggested expected outcomes were not being achieved for 1 of 3 records reviewed. (Patient #2). Findings included: Policy TX-002, last revised 05/22/24 and titled “Coordination of Care,” revealed, “The HHA [Home Health Agency] 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.” Patient #2 was admitted on 03/08/24 with a diagnosis of Hyperkalemia (elevated potassium level in blood); pain in left ankle; Hemiplegia (paralysis of one side of the body) following cerebral infarction (stroke) affecting left, non-dominate side. The plan of care (POC) dated 03/08/24-05/03/24 included orders for physical therapy (PT) to see the patient 1 time a week for 1 week, 2 times a week for 2 weeks, then 1 time a week for 5 weeks. During the PT visit on 03/08/24 at 8:43 AM, Employee #5, physical therapist, stated, “Patient states her left shoulder has gotten significantly worse… Patient states she was given pain medication at the hospital but that it has not been effective at managing her pain.” During the PT visit on 03/27/24 at 1:19 PM, Employee #5 stated, “Patient states that her right shoulder is beginning to hurt her more… Patient is beginning to have pain in a [sic] right upper extremity, at this time therapist does recommend that patient limit ambulation to whatever is absolutely necessary to reduce strain on right upper extremity.” On 04/01/24 at 12:14 PM Employee #5 stated, “Patient states she hurt her left wrist while performing sit/stand transfer and is utilizing a brace.” On 04/10/24 at 12:14 PM, Employee #5 stated, “Adaptive equipment using [brand name of resistance bands] for assisted ambulation has been effective in improving ambulation distance however patient continues to be dependent on [brand name of resistance bands] for safe ambulation and it is not a long-term solution… Patient is unable to safely ambulate without use of adaptive [brand name of resistance bands] equipment. Patient has been attempting to ambulate frequently by dragging her left foot or hopping on right lower extremity only…. patient has difficulty putting on and off adaptive [brand name of resistance bands] equipment due to little to no left hand function and decreased strength in right hand.” On 04/17/24 at 11:13 AM, Employee #5 stated, “Patient states his [sic] shoulder has been bothering her more and more… Patient does not have appropriate caregiver assistance with dawning [sic] and doffing [brand name of resistance bands] adaptive equipment which is limiting her ability to ambulate between therapy sessions.” There was no evidence in the clinical record that any of the above changes were communicated with the physician. An interview was conducted on 06/18/24 at 1:45 PM with Employee #5. Employee #5 stated, “Pain in the left shoulder, a rotator cuff injury, as far as I believe they were not planning on treating at the time, it didn’t actually become more of an issue until later when she tried to use the rollator to walk…No, I did not talk to the doctor about the pain or any changes…I’m not sure if I talked to the doctor or not [about the new pain in right shoulder as documented on 03/27/24]…I did not notify the doctor…she got the brace from the doctor…I did not verify that with the doctor’s office.” An interview with Employee #1, agency director, was conducted on 06/18/24 at 2:00 PM. Employee #1 stated, “Mine [expectation] would be that they [clinicians] would notify Employee #and let them know that the regime is not working…I would expect to see that he [Employee #5] documented confirmation on where the brace came from.”

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's 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). This ELEMENT is not met as evidenced by: Based on agency policy, clinical record review, and staff interview, the agency failed to provide adequate notice of discharge to the patient and/or responsible party or physician for 1 of 3 records reviewed. (Patient #1). Findings included: Policy AA-0016, last revised 05/23/24 and titled “Discharge of Patients” was received from the agency director on 06/18/24 at 2:10 PM. This policy revealed, “If a decision is made to terminate services, staff will normally verbally notify non-institutionalized patients and their attending physician/licensed practitioner at least 2 days prior to discharge of the date and time of termination of services…or within a specified time frame according to state regulation. These verbal communications will be documented in the patient’s chart.” Patient #1 was admitted to the agency on 04/01/24 with diagnoses including chondrocalcinosis of the right knee (a form of arthritis that causes calcium crystal deposits in the joints) and muscle weakness. Plan of Care from 04/01/24 to 05/30/24 revealed orders for skilled nursing one time per week for nine weeks, physical therapy one time per week for one week, two times per week for two weeks, and one time per week for six weeks, occupational therapy one time per week for five weeks, and speech therapy effective 04/14/24 one time per week for one week, once every three weeks for three weeks, and one time per week for three weeks. On 05/03/24, Employee #4, scheduler, entered a coordination note and documented, “Left message to discuss ins [insurance] denial with patient requesting a return phone call.” There was no evidence of further follow-up or attempts to notify the patient or caregiver of the insurance denial. Patient #1 continued to receive home health services as ordered until 05/29/24. On 05/29/24, Employee #6, speech therapist, documented that Patient #1 had dementia and “…educated pnt [patient] on reasons for DC [discharge] today vs [versus] recertification as her current dx [diagnosis] provided by PCP [primary care provider] does not support continuing ST [speech therapy] services as needed…instructed pnt as communicated by [name of clinical manager], that if she wishes to continue with ST services she will need to fu [follow up] with PCP and have new order sent to HH [home health] agency…also reviewed pnt NOMNC [Notice of Medicare Non-Coverage] and ability to appeal if she decides.” The NOMNC document listed 05/29/24 as the effective date of coverage. There was no evidence in the clinical record of care coordination with the patient, responsible party or PCP prior to 05/29/24. In an interview on 06/18/24 at 1:12 PM, Employee #4 stated that she did not receive a return call from Patient #1 and “If we’re not able to [reach the patient by phone] then yes, we return calls, but I think they [Patient #1 and/or caregiver] were made aware by clinicians.” In an interview on 06/18/24 at 1:55 PM, Employee #6 stated “Originally my plan was to continue [speech therapy services] …I was notified that I was unable to recert [recertify] and it had to be a discharge per insurance. I communicated that to the patient and the patient’s son who was present that day…he’s not the primary caregiver who lives in the home. He was visiting from out of town. I would typically always include whoever the POA [power of attorney] is…and I document that as well.” In an interview on 06/18/24 at 1:56 PM, Employee #1, agency director, stated “We let families know, we let patients know and we let physicians know that we will not be able to continue services. We reach out to physicians to let them know that we don’t have an additional auth [insurance authorization]. We try to let the patient know as soon as we find out so they can contact their case manager and see if they can help us get additional auth.”

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 agency policy, clinical record review, and staff interview, the agency failed to conduct an ordered medical social work evaluation for 1 of 1 record reviewed with orders for medical social work evaluation. (Patient #5) Findings included: Policy TX-001, last revised 06/22/23 and titled, “Physician Orders and Medical Supervision of the Plan of Care” was received from the agency’s area vice president on 12/12/23 at 11:00 AM. This policy revealed, “The agency provides care and services according to the most recent physician order. Policy TX-002, last revised 05/04/23 and titled, “Coordination of Care” was received from the agency director on 12/12/23 at 10:45 AM. This policy revealed, “The HHA [home health agency] must…integrate orders from all physicians involved in the plan of care.” Patient #5 was admitted to the agency 10/28/23 with diagnoses including left humerus (bone between shoulder and elbow joint), atrial fibrillation (irregular heart rhythm), weakness and a history of falls. Clinical record review included a Plan of Care from 10/28/23 to 12/26/23 which revealed, “…PATIENT IS VERY WEAK AND UNSTEADY ON HER FEET AND WOULD GREATLY BENEFIT FROM PT [physical therapy], OT [occupational therapy], SLP [speech and language pathologist], AND A SOCIAL WORK EVALUATION. FAMILY LIVES IN CHARLOTTE SO THEY ARE UNABLE TO BE THERE ON A DAILY BASIS…” An order for a medical social worker evaluation was entered into the electronic medical record (EMR) and added to the 485 on 11/15/23. At the time of survey, there was no evidence that a medical social worker evaluation was conducted. In an interview on 12/12/23 at 10:23 AM, the agency’s area vice president stated, “It looks like the social worker order was put in [the EMR] and they didn’t put the order in for the next week to get it plotted and scheduled…”

An onsite, unannounced recertification survey of the emergency preparedness plan was conducted 08/21/23 to 08/23/23. No deficiencies to the Medicare Conditions of Participation were identified.

An onsite, unannounced recertification and follow-up survey was conducted 08/21/23 to 08/23/23. Deficiencies to the Medicare conditions of participation were identified. The following previous citations returned to compliant status 08/23/23: G434, G580, G706, G718, G806, G1012.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and staff interview, the agency failed to maintain an accurate medication list for 3 of 6 home visits conducted during survey (Patients #13, #14 and #15). Findings included: A policy, Drug Regime Review Home Health (revised 01/20/23), was received on 08/23/23 at approximately 12:45 P.M. from the agency director. The policy stated, “The clinician will also ask to periodically allow them to visualize all the medications the patient is currently taking. [Medications will be visualized minimally at SOC [start of care], Recert/Follow-up, ROC [resumption of care], and upon any medication changes.]” Patient #15 was admitted on 02/13/2023 with diagnoses of non-pressure chronic ulcer right lower leg, acute on chronic diastolic (congestive) heart failure, and dependence on oxygen. The plan of care for 08/12/2023-10/10/2023 included orders for skilled nurse (SN) visits 2 times a week for 8 weeks and 1 time a week for 1 week. A home visit was conducted with LPN #4 on 08/23/2023 at 9:00 A.M. A review of current medications was conducted with patient #15. The review revealed the following omitted medications: Eliquis (blood thinner) 15mg 1 tablet 1 time a day, nitroglycerin (treats chest pain) 0.4 mg as directed, and Potassium Chloride (prevents low potassium) extended release 10 mEq 2 times daily. Patient #15 was no longer taking Benazepril (treats high blood pressure) 20 mg daily and simvastatin (treats high cholesterol) 20 mg. An interview was conducted with patient #15 on 08/23/23 at approximately 9:30 A.M. Patient #14 stated that the blood pressure and cholesterol medications were discontinued months ago and, “I have been on Eliquis, nitroglycerin, and potassium for years and years. No one [agency staff] has ever looked at my medications like this.” An interview was conducted with LPN #4 on 08/23/23 at 9:45 A.M. LPN #4 stated, “I always ask if there have been any changes [medication]. If I see someone regularly I, do it [complete medication review] about once every 2 weeks.” An interview was conducted with the agency director on 08/23/23 at 9:50 A.M. The agency director stated, “Complete medication review should occur every visit by the nurse or physical therapist.” 1. Patient #13 was admitted to the agency on 07/28/23 with diagnoses including age-related osteoporosis (condition causing weak, brittle bones), peripheral vascular disease (narrowed blood vessels causing decreased blood flow to the limbs) and polyneuropathy (damage to multiple peripheral nerves). Plan of Care from 07/28/23 to 09/25/23 revealed orders for physical therapy one time per week for one week, two times per week for one week, and one time per week for seven weeks, occupational therapy one time per week for one week, speech therapy one time per week for one week, one time every four weeks for four weeks, and one time per week for three weeks, and medical social worker one time per week for one week. A home visit of Patient #13 was conducted with Employee #14 on 08/22/23 at 12:00 PM. During the visit, Employee #14 reviewed Patient #13’s medications and that were in a medication blister pack and asked the patient if she was taking gabapentin. Patient #13 stated, “I take what’s there [in the blister pack]…if it’s there I take it…” Gabapentin was not listed as a current medication for Patient #13 at the time of the home visit. In an interview on 8/23/23 at approximately 1:30 PM, Employee #12, physical therapist, stated that he needed to contact the physician to see if the patient had had any recent appointments and verify any medication changes. In an interview on 8/23/23 at approximately 1:35 PM, Employee #1, agency director, stated that Employee #12, “…needs to clarify with the physician and see whether or not she needs to be taking that medication…” 2. Patient #14 was admitted to the agency on 04/17/23 with diagnoses including hypertensive chronic kidney disease (kidney disease caused by high blood pressure), vascular dementia (dementia caused by impaired blow flow to the brain), esophagitis (inflammation of the esophagus), and history of urinary tract infections. Plan of care from 08/05/23 to 10/03/23 revealed orders for skilled nursing one time per week for one week and once every two weeks for six weeks, and speech therapy one time per week for nine weeks. A home visit of Patient #13 was conducted with Employee #14 on 08/22/23 at 2:00 PM. A medication list was received from the assisted living facility where the patient resided. On comparing the agency’s medication list to the list received from the assisted living facility, multiple discrepancies were identified. The assisted living facility’s medication list included orders for the following medications that were not on the agency’s medication list: furosemide 20 milligrams, one tablet by mouth daily (for leg edema); potassium and sodium phosphates oral packet 280-160-250 milligrams, one packet by mouth daily (for low phosphorous); potassium chloride extended release oral tablet, 20 milligrams by mouth daily (for low potassium); loperamide hydrochloride two milligrams, one tablet by mouth every six hours as needed for diarrhea; polyethylene glycol powder 17 grams mixed with eight ounces of fluid by mouth every 24 hours as needed for constipation. The agency’s medication list included orders for senna laxative 8.6 milligram tablets, two tablets daily (for constipation). This medication was listed on the facility’s medication list as an as-needed medication that was discontinued on 08/01/23. Additionally, the agency’s medication list included trazodone 50 milligrams, one tablet every 6 hours (for anxiety) but the facility’s medication list had this medication listed as needed. In an interview on 08/23/23 at approximately 2:00 PM, Employee #1 stated that the expectation of clinicians would be for a complete medication reconciliation to have been conducted when Patient #14 was recertified for the benefit period beginning 08/05/23.

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 clinical record review and staff interviews the agency failed to notify the physician of a patient's inability to attend wound clinic appointments (#2) for 1 of 1 patients with wound clinic referrals and failed to notify the physician of changes in weight for 1 of 2 patients with an order for weight monitoring (#15). Findings included: 2. Patient #15 was admitted on 02/13/2023 with diagnoses of non-pressure chronic ulcer right lower leg, acute on chronic diastolic (congestive) heart failure, and dependence on oxygen. The plan of care for 06/13/2023-08/11/2023 included orders for skilled nurse (SN) visits 1 time a week for 1 week and 2 times a week for 8 weeks and to report (to physician/nurse practitioner) increased edema or weight gain of more than 2 pounds in 1 day or more than 5 pounds in 1 week. The plan of care for 08/12/2023-10/10/2023 included orders for SN visits 2 times a week for 8 weeks and 1 time a week for 1 week and to report (to physician/nurse practitioner) increased edema or weight gain of more than 2 pounds in 1 day or more than 5 pounds in 1 week. For the SN visit of 08/11/2023, LPN #6 included evidence of a 10-pound weight gain over 4 days. For the SN visit of 08/15/2023, RN #7 included evidence of a 5-pound weight gain over 4 days. There was no evidence in the clinical record of the physician/nurse practitioner being notified. An interview was conducted with LPN #6 on 08/22/23 at approximately 11:40 A.M. LPN #6 stated, “I would have called the doctor, but I didn’t notice the 10-pound weight gain.” An interview was conducted with RN# 7 on 08/22/23 at approximately 1:00 P.M. RN #7 stated, “I left a message for her NP [nurse practitioner]. I did not document [in the clinical record] the message for the NP. I did not hear back from the NP. Typically, I would put [document] calls to the doctor or NP in the note [visit note] or a coordination note. I should have called the NP back [to follow-up].” An interview was conducted with the agency director on 08/22/2023 at approximately 1:15 P.M. The agency director stated that the physician or nurse practitioner should have been notified with each documented weight gain and the clinical manager should be notified to follow-up. 1. Patient #2 was admitted to the agency on 08/27/22 with diagnoses including Stage III pressure ulcer (wound that goes into the fatty layer of skin) of right and left buttocks and multiple sclerosis (a chronic disease that affects the central nervous system). Plan of Care from 08/27/22 to 10/25/22 revealed orders for skilled nursing one time per week for one week, four times per week for one week, two times per week for seven weeks, and one time per week for one week; physical therapy one time per week for two weeks, two times per week for two weeks, one time per week for one week, and one time per week for three weeks; occupational therapy one time per week for one week; and home health aide one time per week for three weeks. Employee #11, registered nurse, conducted a skilled nursing visit on 08/31/22. This visit note revealed, “…they [primary care physician’s office] have called in a referral to [name] wound clinic…this nurse then contacted [name] wound clinic to update them that patient would need transport service ie [sic] wheelchair van as she cannot transfer to the car.” Employee #11 also conducted a skilled nursing visit on 09/06/22 and documented that a message was left with the wound clinic nurse line that Patient #2 still needed an appointment. Employee #8, registered nurse case manager, conducted a skilled nursing visit on 09/09/22. This visit note revealed, “Patient reports she is unable to schedule wound clinic appt [appointment] due to inability to transfer fr9m [sic] chair to car.” There was no evidence in the clinical record that Employee #8 contacted the wound clinic or the primary care physician (PCP) regarding the patient’s inability to visit the wound clinic as ordered. In an interview on 08/23/23 at approximately 1:30 PM, Employee #8 stated, “The patient didn’t want to go to a wound clinic ... As soon as we got her to be able to transfer, she wanted to go to outpatient.” Employee #8 stated that the PCP “knew” that Patient #2 was not going to the wound clinic, however, there was no evidence in the clinical record indicating that the PCP was aware. In an interview on 08/23/23 at approximately 2:25 PM, Employee #1, agency director, stated that the expectation of clinicians would be that the physician was notified regarding the patient’s inability or unwillingness to attend the wound clinic.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and staff interviews the agency failed to prepare accurate clinical notes for 1 of 5 discharged patients (#3) and failed to include Central Line measurements for 1 of 1 patient with a central line (#8). Findings included: A policy, Patient Assessment/Reassessment (revised 03/03/22), was received on 08/23/23 at approximately 8:00 A.M. from the agency director. The policy stated, “The comprehensive assessment must accurately reflect the patient’s status.” A policy Central Venous Access Device (CVAD) Dressing Change (revised 03/07/23), was received on 08/22/23 at 12:05 P.M. from the agency director. The policy stated, “DOCUMENT IN THE CLINICAL RECORD:… Length of external catheter and segment measured.” Patient #3 was admitted on 04/10/2022 with a diagnosis of Non-pressure chronic ulcer of other part of right foot with unspecified severity. The plan of care included orders for skilled nurse (SN) visits 1 time 1 week for 1 month, 2 times a week for 2 weeks, 1 time a week for 5 weeks, and 4 PRN (as needed) visits. For the SN visit of 04/10/2022 SN # 5 stated, “Right foot Plantar [bottom of foot] area/Venous stasis ulcer…Amputation RLE [right lower extremity] BKA [below the knee amputation].” Nurse # 5 was not available for an interview. An interview was conducted with clinical manager #3 on 08/22/2023 at approximately 12:15 P.M. Clinical manager #3 stated that an amputation RLE BKA and a right planter foot wound cannot exist on the same patient. [since the patient has had an amputation of the foot] Patient #8 was admitted on 04/11/2023 with diagnoses of acute and sub-acute infective endocarditis (infection of the hearts inner lining) and bacteremia (presence of bacteria in the blood stream). The plan of care for 06/10/2023-08/08/23 included orders for skilled nurse (SN) visits 1 time a week for 9 weeks and weekly maintenance of the central line (dressing and cap changes with flushes) effective 07/18/2023. There was no evidence in the clinical record of central line measurements for the SN visits of 07/25/2023 and 07/31/2023. An interview was conducted with LPN #10 on 08/22/23 at approximately 1:00 P.M. LPN #10 stated, “I know that we measured every time, always 1cm, I can’t get into the record now.” An interview was conducted with the agency director on 08/22/23 at approximately 1:05 P.M. The agency director stated, “Line [central line] should be measured at least weekly and as needed with dressing changes.”

An unannounced, onsite complaint investigation was conducted on 01/04/22. Deficiencies to the Medicare Conditions of Participation were identified.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review and staff interview, the allegation that the agency failed to provide timely notification of discharge to 1 of 3 patients (Patient #1) is substantiated. Findings included: The following policies were received from the agency director on 01/04/22 at approximately 10:00 AM: Policy #RI.1, titled Rights/Responsibilities, effective 07/15/03 and last revised 11/10/17, revealed, “…Each patient will be an active, informed participant in his/her plan of care…” Policy #PE.6, titled Discharge Planning, effective 08/05/05 and last revised 11/09/17, revealed, “…Health care personnel will assist patients regarding their discharge by:…Consulting with the patient, representative/caregiver, and physician regarding the need for the discharge from the company…” and “…Documenting efforts and communications about discharge activities made within the clinical notes…” Patient #1 was admitted to the agency on 06/08/21 with a primary diagnosis of Type II diabetes mellitus with foot ulcer. Plan of Care from 10/06/21 to 12/04/21 revealed an order for skilled nursing services 1 time per week for 1 week, 2 times per week for 1 week, 1 time per week for 1 week, and 2 PRN (as needed). This Plan of Care further revealed, “She (Patient #1) must user her electric wheelchair and assist of another person to leave the house.” The following skilled nursing visits were performed by Employee #2, the registered nurse case manager. Skilled nursing visit note of 10/14/21 revealed, “Wound is not improving as it should. width [sic] of wound is slowly increasing. Drainage has increased and it is bloody. Patient advised to stay off foot as much as possible. She states that she is.” Skilled nursing visit note of 10/21/21 revealed, “Wound has not improved. Extra padding added to bottom of dressing to act as a buffer. Patient advised to stay off of foot. She verbalized understanding.” Skilled nursing visit note of 10/25/21 revealed, “Wound has not improved. Extra padding added to bottom of dressing to act as a buffer. Patient advised to stay off of foot. She verbalized understanding.” Skilled nursing visit of 11/01/21 revealed, “Patient’s wound has not improved. Patient states that she is not staying off of it when she goes out. She declines to use the scooter at the store or hers [sic]. The patient also says she does not wear the boot because MD (Medical Doctor) said she does not have to wear it. Informed her to stay off the foot as much as possible or the wound would never heal.” Skilled nursing visit note of 11/04/21 revealed, “Patient refuses to wear recommended boot to add support.” Skilled nursing visit note of 11/18/21 revealed, “Patient has been noncompliant by not reducing ambulation and wearing support boot when ambulating as directed by MD and nurse. She has repeatedly been told of what [sic] she needs to do to help the healing process. She will verbalize understanding when talking to her. However, there have been multiple times where she will admit that she does not use the automatic wheelchair when she goes out and stated that she filed a complaint against her CAP (Community Alternatives Program) worker because they make her use the wheelchair during shopping visits. She also does not wear her boot that her podiatrist recommends, saying that the MD told her she did not have to wear it anymore. I spoke with (medical assistant and physician’s assistant for primary care physician) multiple times about issues of noncompliance and also confirmed she should be wearing the boot…” There is no evidence in the clinical record of patient education regarding the potential for discharge related to noncompliance. Additionally, there is no evidence in the clinical record of physician notification regarding patient noncompliance prior to the 11/18/21, which was the final skilled nursing visit. In an interview with Employee #4, the Clinical Manager, on 01/04/22 at approximately 2:50 PM, Employee #4 revealed, “I had reviewed the notes…(Employee #2) is new to home health so I have to get on (Employee #2) regarding documentation.” Employee #4 agreed that the clinical record should have included documentation regarding patient education of the potential for discharge related to noncompliance and that the clinical record should have included documentation of physician notification of patient non-compliance prior to the final skilled nursing visit.

An onsite recertification survey was conducted June 1, 2021-June 4, 2021. No deficiencies noted to the Emergency Preparedness Program.

An unannounced onsite recertification survey was conducted June 1, 2021-June 4, 2021. Standard level deficiencies to the Medicare CoP were identified.

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 agency policy review, clinical record review and staff interviews the agency applied Silvadene to a wound without a physician's order for 1 of 2 patients who was receiving negative pressure wound therapy [#5]; prefilled a medication tray for 1 of 1 chart without an order [#15]. The findings included: The policy, Care Planning Process [5/14/19], was provided by the agency director on 6/4/21 at approximately 12:30 pm. The policy stated, “…The clinical plan of care included pertinent diagnoses…goals and interventions appropriate for each discipline…treatments…” 1. Patient # 5 had a Start of Care [SOC] date of 5/20/20 and diagnoses of Cutaneous Abscess of the Groin and Type 1 Diabetes Mellitus with Foot Ulcer. A review of the Plan of Care [POC] for the certification period 5/20/20 to 7/18/20 revealed orders for SN [skilled nursing] 2 times a week for 1 week and 3 times a week for 9 weeks. A review of the clinical record revealed on 5/26/20 and 5/28/20 RN # 15 performed the following wound care to the anterior medial foot: “Cleaned with normal saline and applied Silvadene and covered with gauze." A review of the POC revealed no order for Silvadene to the anterior medial foot. An interview was conducted with RN # 15 on 6/4/21 at approximately 11:15 am. RN # 15 confirmed there was no order for Silvadene to be applied to the foot. "The patient and his dad said the hospital was using the Silvadene before we admitting him to home health." 2. Patient # 15 had a Start of Care [SOC] date of 5/9/21 and a diagnosis of Hypertensive Urgency [a clinical situation in which blood pressure is very high with minimal or no symptoms]. A review of the Plan of Care for the certification period 5/9/21 to 7/9/21 revealed orders for SN [skilled nursing] 1 time a week for 1 week; 2 times a week for 1 week; 1 time a week for 7 weeks. A review of the clinical record revealed a routine visit was made on 5/11/21 by RN # 11. RN # 11 documented the following information in the narrative section of the visit note, “…SN arrived at patients [sic] home at previously scheduled time for follow up visit and to set up patients [sic] medication trays.” On 5/24/21 LPN # 12 made a routine visit. A review of the clinical record revealed LPN # 12 documented the following information, “…SN filled medication trays for 2 weeks…” A phone interview was conducted with RN # 11 on 6/4/21 at approximately 11 am. During the interview RN # 11 confirmed the POC did not include an order for the SN to prefill a medication tray.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and staff interviews skilled nursing failed to provide an ongoing interdisciplinary assessment [consistent wound measurements] with 2 of 2 patients with a wound vac [#3 and 5]. The findings included: The policy, “All Wounds” no date, was provided by the agency director on 6/3/21 at approximately 3 pm. The policy stated, “All wounds require measurements at least weekly even if it’s a surgical incision and unlikely to change, even for short term patients, even for non-infected wounds, even for wounds that are doing well…” 1. Patient # 3 had a Start of Care [SOC] date of 9/23/20 and a diagnosis of Pressure Ulcer of Left Buttock Stage II and Type 2 Diabetes Mellitus with Diabetic Polyneuropathy. A review of the Plan of Care [POC] for the certification period 11/22/20 to 1/20/21 revealed orders for SN [skilled nursing] 1 x time a week for 7 weeks. A Resumption of Care [ROC] visit was done on 12/13/20 with orders to Primary diagnosis of Pressure Injury Left Buttock Stage IV and SN to see patient 2 times a week for 1 week; 3 times a week for 4 weeks; 2 times a week for 1 week and “…SN 3 times per week for wound Vac dressing changes, monitoring and teaching…Cleanse wound with NS [normal saline]…Therapy setting 125mgHg…” A review of the clinical record revealed the stage IV pressure ulcer noted on the left buttock was measured on 12/13/20 and the measurements were 5 cm x 3 cm x 1.25 cm. Further review of the clinical record revealed LPN # 18 made a routine visit on 12/21/20, RN # 9 made a routine visit on 12/23/20 and 12/24/20. The next wound measurements were obtained on 12/31/20 by LPN # 18. The wound measurements were 6 cm x 5 cm x 2 cm. Patient # 3 received 3 SN visits the week of 1/2/21, 3 SN visits the week of 1/10/21 and was discharged on 1/29/21 to a skilled nursing facility with the wound vac in place. No wound measurements were obtained after the visit on 12/31/20. An interview was conducted with RN #5 on 6/4/21 at approximately 11:10 am. During the interview RN # 5 stated, “We knew that would measurements were a problem and we had already started chart audits to identify these records.” 2. Patient # 5 had a Start of Care [SOC] date of 5/20/20 and diagnoses of Cutaneous Abscess of the Groin and Type 1 Diabetes Mellitus with Foot Ulcer. A review of the Plan of Care [POC] for the certification period 5/20/20 to 7/18/20 revealed orders for SN [skilled nursing] 2 times a week for 1 week and 3 times a week for 9 weeks. A review of the clinical record revealed the RN # 15 completed the admission Oasis [Outcome and Assessment Information Set] on 5/20/20 and identified 3 wounds. The location of the wounds were: Anterior medial foot [diabetic ulcer], left abdomen/groin [surgical wound] and upper leg/thigh [surgical wound]. A review of the clinical record revealed the patient received 19 SN visits from 5/20/20 to 7/18/20. The diabetic ulcer located on the anterior medial foot was measured at the time of admission and the measurements were 8 cm x 9 cm x .5 cm. This wound was not measured again until the week of 6/20/20. After the measurements the week of 6/20/20 the wound was not measured again until the week of 7/13/20. The surgical wound located at the left abdomen/groin was measured weekly from 5/20/20 through the week of 6/21/20. After the wound was measured the week of 6/21/20 no wound measurements were obtained until the week of 7/13/20 [2 weeks with no wound measurements]. The surgical wound located on the upper leg/thigh was not measured during the 5/20/20-7/18/20 time frame. An interview was conducted with RN # 4 on 6/4/21 at approximately 11:25 am. During the interview the RN confirmed the wounds were not measured weekly. RN # 4 stated, "We have been auditing charts to find missing wound measurements."

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on clinical record review and staff interviews the agency failed to communicate with the physician changes related to a wound vac for 1 of 2 patients with a wound vac [#3]. The findings included: Patient # 3 had a Start of Care [SOC] date of 9/23/20 and a diagnosis of Pressure Ulcer of Left Buttock Stage II and Type 2 Diabetes Mellitus with Diabetic Polyneuropathy. A review of the Plan of Care [POC] for the certification period 11/22/20 to 1/20/21 revealed orders for SN [skilled nursing] 1 x a week for 7 weeks. A Resumption of Care [ROC] visit was done on 12/13/20 with orders to change the primary diagnosis of Pressure Injury Left Buttock Stage IV and SN to see patient 2 times a week for 1 week; 3 times a week for 4 weeks; 2 times a week for 1 week and “…SN 3 times per week for wound Vac dressing changes, monitoring and teaching…Cleanse wound with NS [normal saline]…Therapy setting 125mgHg…” A review of the clinical record revealed during the SN visit by LPN # 18 on 1/4/20 the LPN documented, “…Routine visit for wound care and assessment…patient ran out I’ve [sic] wound vac supplies…placed wet to dry…” Further review of the clinical record revealed the wound vac was not applied again until 1/7/21. There was no communication with the physician to discuss leaving the vac off. An interview was conducted with RN # 7 on 6/4/21 at approximately 12 noon. RN # 7 confirmed no communication with the physician related to the wound vac not being reapplied on 1/4/21 was noted.

Supervision of home health aides CFR(s): 484.80(h) Standard: Supervision of home health aides. This STANDARD is not met as evidenced by: Based on agency policy review, clinical record review and staff interviews the agency failed to do ensure aide supervisory visits were performed for 1 of 1 charts receiving aide services [#6]. The findings included: The policy, Responsibilities/Supervision [6/26/20], was provided by the agency administrator on 6/4/21 at approximately 1 pm. The policy stated, “…Home health aide supervisory visits will be conducted on site at least every two weeks by skilled personnel…” Patient # 6 had a Start of Care [SOC] date of 5/5/21 and a diagnosis of Encounter for Orthopedic Aftercare Following Surgical Amputation. A review of the Plan of Care [POC] for the certification period for 5/5/21 to 7/3/21 revealed orders for SN [skilled nursing] 1 time a week for 1 week; 2 times a week for 1 week; 1 time a week for 3 weeks and HHA [home health aide] 1 time a week for 1 week and 2 times a week for 2 weeks. A review of the aide care plan revealed the patient needed assistance with personal care. Further review of the clinical record revealed the HHA made 1 visit the week of 5/6/21, 2 visits the week of 5/10/21, 2 visits the week of 5/17/21 and 2 visits the week of 5/24/21. Further review of the clinical record revealed the RN did not make any visits after the SOC and all SN visits were made by the LPN. No aide supervisory visits were conducted from 5/6/21 through 5/27/21. An interview was conducted with RN # 4 on 6/4/21 at approximately 10 am. During the interview the RN confirmed the RN failed to see the patient for any aide supervisory visits.

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 education document review, clinical record review and staff interview, the agency failed to document a complete wound assessment for 1 of 6 patients (Patient #4) with wounds. Review of the unnamed, undated wound care education documents provided by the Agency Director on 06/04/21 at approximately 1:00 PM revealed “ALL Wounds Require Measurements at least WEEKLY…” Patient #4 was admitted to the agency on 01/06/20 with diagnoses including surgical repair of the right tibia/fibula, Type 2 diabetes, hypertension, congestive heart failure, and the presence of pacemaker. Review of the Plan of Care dated 01/06/20 to 03/05/20 revealed orders for skilled nursing 2 times per week for 1 week, 1 time per week for 4 weeks, and 2 PRN (as needed) visits, and occupational therapy 2 times per week for 2 weeks and 1 time per week for 2 weeks. Clinical record review revealed an initial assessment completed on 01/06/20. The OASIS (Outcome and Assessment Information Set) revealed the presence of two Stage 2 (open area of outer layer of skin) wounds. There is no evidence of further documentation including visualization or measurements related to wounds in the 01/06/20 initial assessment. The occupational therapy visit of 01/08/20 referenced “2 wounds noted, R (right) heel, R (right) ankle.” The next skilled nurse visit of 01/17/20 revealed wound assessment and care provided to a right dorsal foot wound and a right heel wound. There is no evidence of wound measurements obtained at the 01/17/20 visit. Additionally, there is no evidence of wound care orders on the Plan of Care. The patient was hospitalized prior to the next nursing visit. In an interview on 06/04/21 at 12:45 PM, Employee #7 the Clinical Manager, stated that there was email evidence that the nurse who completed the initial assessment had given report to the primary nurse case manager that included information regarding Patient #4’s foot wounds, which he forgot to put in the initial assessment. Employee #7 stated, “This information did not make it to the chart.” The Clinical Manger verbally confirmed that wound measurement timeframe expectation is weekly.