Every finding on record at Integrity Home Care, Inc

A complaint investigation was completed on 06/13/2024 at the home health provider. The provider had 542 current patients. The complaint is substantiated. One or more of the allegations reported were verified and deficiencies were cited that are related to the allegations being investigated. §484.75 Condition of Participation - Skilled Professional Services was identified out of substantial compliance at an immediate jeopardy (IJ) level: An immediate jeopardy level for actual harm to one patient (Record/Patient #1) and potential for future harm to additional patients was identified during the survey. The findings were confirmed as immediate jeopardy by the Centers for Medicare and Medicaid Services (CMS). On 06/10/2024, at 3:50 PM, the administrator was informed verbally and in writing via the IJ Template, of the finding(s) identified at an immediate jeopardy level. A formal written removal plan was submitted by the home health provider prior to the survey exit. This removal plan was reviewed by CMS and the SA. The removal plan was determined to be acceptable. By survey exit on 06/13/2024, the satisfactory removal plan had been initiated related to the immediate jeopardy findings. The condition-level deficiency identified at §484.75 remains as cited at a condition level. A home health provider that is found out of compliance with any Condition of Participation evaluated as part of a complaint survey and found to have furnished substandard care may not train or competency evaluate home health aides for a period of two (2) years following the date of the survey (restriction for this instance ends on 06/13/2026). A deficiency has been cited at 484.80(f)(3) - See Tag G0782.

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 policy review, record review, and interview, the home health provider failed to: -Ensure nursing staff followed the provider's policy and procedures regarding communication with patients and document a complete occurrence (incident) report (G702); and -Ensure nursing staff provided timely follow-up, assessment, instructions for notifying the on-call service and/or notify the on-call service to contact the patient, and instruct the patient to seek medical attention when the patient reported abnormal symptoms, provided complete wound assessments; documented a complete assessment of a patient's report of fainting/dizziness and document what specific abnormal findings were reported to the physician. This was identified at an immediate jeopardy level (G706). The cumulative effect of these deficient practices has the potential to affect all patients served by the provider.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure staff followed their policies and procedures regarding communication with patients in one of five records reviewed (Record/Patient #1). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Confidentiality of Protected Health Information (PHI),” revised 10/23/2023, showed in part that PHI includes all medical and care-related information, specific to an individual, that can be identified by use of name, address, telephone, and mobile numbers. Cell phones, cordless phones, texting, and other electronic communications will be used only when standard telephones are not available. Any unsecured communication (texts, instant messaging, or other electronic communication) must be completely de-identified prior to transmission. Review of an undated form titled, “Technology Usage and Protected Health Information Agreement,” showed in part that each person with access to protected health information must: - Not exhibit or divulge the contents of any record/report except to fulfill a work assignment and in accordance with policy; and - Not divulge any information that identifies PHI. RECORD/PATIENT #1: Review of text messages printed by the provider from RN A's phone showed on 05/16/2024, the patient texted RN A regarding abnormal symptoms he/she had, and the patient and RN A texted back and forth on 05/18/2024 and 05/19/2024. During an interview on 06/03/2024, at 12:35 PM, the administrator stated that patients are supposed to call the office. Sometimes the staff do not give patients their phone number, but the patients had it from their caller ID (identification). Texting is not the preferred mode of communication, but with some clients it is their preferred mode. The clinicians can answer the patient’s texts. During an interview on 06/10/2024, at 3:10 PM, the administrator stated that for texting to be secure it needed to be inside a secured program like a patient portal within a medical system. The texting from the patient to the nurse was not a secure mode.

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 policy review, record review, and interview, the home health provider failed to ensure the registered nurse (RN) provided timely follow up, assessment, instruction, and coordination for three of five patients sampled. The home health nurse failed to notify on-call staff and/or arrange an on-call visit for the patient, provide instruction for the patient to seek medical attention, or notify the physician when a patient who reported to the nurse that he/she had a fall, fever, displayed non-sensical speech throughout texts, and a big infected very painful bump that took up the whole right side of the genitalia (the external sexual organs) The patient was subsequently admitted to the hospital for severe sepsis, septic shock (these are life threatening conditions that occur when the body has an extreme response to an infection, causing organ dysfunction), and necrotizing fasciitis (a flesh-eating disease that spreads quickly and destroys tissue under the skin) and required emergency surgery. This example was identified as an immediate jeopardy (Record/Patient #1). The home health failed to ensure nursing staff documented complete wound assessments for a patient (Record/Patient #2). The home health provider failed to document assessment and reporting of fainting/dizziness for a patient (Record/Patient #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Client Care Coordination,” reviewed 03/24/2023, showed in part that care coordination will include assuring coordination of care delivery to meet the client’s needs and involves the client, client’s representative, if any, and caregiver as appropriate, and integrating services to assure the identification of client needs and factors that could affect safety and treatment effectiveness and the coordination of care provided by all disciplines. Review of the provider’s policy titled, “Communication with Physicians,” reviewed 03/24/2023, showed in part that throughout the duration of service, whenever a change in client status occurs that requires the physician to be notified, the communication will be documented. This communication can be documented on the clinical notes, nurses’ notes or on a coordination of service form. The SBAR (situation, background, assessment, and recommendation) method of communication with physicians is encouraged due to its effectiveness. Review of the provider’s policy titled, “On Call Availability and Access to Services,” revised 05/03/2021, showed home health care services can be accessed 24 hours a day, 7 days per week through an on-call system. An on-call manager with access to an RN for clinical consultation is available after business hours. Clients and employees are instructed on procedures for contacting the providers after hours at admission and orientation. The client, caregivers, and facility staff receive written information at the time of admission regarding how and when to access care after business hours. Review of the provider’s policy titled, “Wound Care – Assessment and Treatment,” revised 09/09/2021, showed in part that staff should verify physician’s orders, which should include frequency of dressing change, location of wound, solution and procedure for cleansing, as applicable, specific treatment to be applied, type of dressing, and who should perform the wound care. Documentation should include wound location, drainage, communication with physician regarding client progress, response, or recommended need for a change in treatment. The RN or PT (physical therapist) will complete an assessment of the wound by measuring, assessing, and documenting effective wound treatment per physician orders. The ICC (integumentary (pertaining to the skin) command center (a wound assessment tool) will be completed at every visit and measurements completed and documented weekly. RECORD/PATIENT #1: Review of the record showed the patient was admitted to service on 04/02/2024. Diagnoses included acute pancreatitis (an inflammation of the organ (pancreas), type 2 diabetes mellitus (a group of diseases that results in too much sugar in the blood), and non-pressure chronic ulcer of the left lower leg (a skin ulceration due to poor circulation). Review of text messages from the patient to registered nurse (RN)-A showed: On 05/16/2024 (Thursday), at 7:43 PM, the patient wanted to update the home health nurse that he/she had a fall yesterday and thought he/she was running a fever, "everything is intact except my butt and elbow"; On 05/16/2024 and 05/17/2024 (Friday), the nurse failed to respond to the patient’s text; On 05/18/2024 (Saturday), at 9:32 AM, the patient texted "I hate to bother you on your day off, but my blood sugar is 180. Is there anything I can do for that? I haven’t been eating regularly the last few days"; At 4:48 PM, I feel a little bit better. Monday would be good (unclear what this referred to); At 6:04 PM, (two days after the patient’s first text) the nurse texted the patient and asked if the patient felt like he/she had an infection. "How is your appetite now? Getting enough hydration?"; At 6:04 PM, the patient responded that he/she had a big, infected bump on the “hoo ha”. It took up the whole right side. At 6:08 PM, "I’m drinking water the best I can"; At 6:08 PM, the nurse texted “Yowsa”! Is it painful to? Do you think you need to get it looked at? Not sure if you’ve had one before; At 6:11 PM, the patient responded no, but, at the moment I don’t have a doctor until June 5. The patient stated that he/she wanted to scream every time he/she sat down and he/she had never had one this size; At 6:12 PM, the nurse asked if he/she had a way to do a sits (sitz bath, a warm water bath you sit in to relieve discomfort in the perineal (genitalia) region) or an Epsom salt soak? I bet you have a Bartholin glad (gland) cyst (a fluid filled lump inside the vaginal opening) or infected follicle (inflammation of a hair follicle). Very painful; At 6:18 PM, the patient responded that he/she could not really tell. I’m dying long ass lips. Nothing. (non-sensical, unsure what this meant, could be indicative of something abnormal with the patient); At 6:19 PM, the nurse responded, “I’m so sorry! Maybe we can make some calls Monday; At 6:23 PM, the patient responded, “Once they dropped her off, he watched the parking lot she got (non-sensical, unsure what this meant); At 6:23 PM, the nurse responded, “??”; At 6:24 PM, the patient responded that we can get ahold of somebody in the morning that would be awesome; At 6:25 PM, the nurse responded, “I’ll see what I can do; At 6:25 PM, the patient responded Ty (thank you); The nurse failed to document he/she provided instruction on how to contact the on-call staff, make arrangement for the patient to be seen by on-call staff, or advise to go to the emergency room to seek medical attention; On 05/19/2024 (Sunday) at 11:09 AM, the patient texted, “Did I miss you? I’m sorry somebody just informed me at Sunday; At 12:09 PM, the nurse responded, “It’s OK. I’ll be there around 9:00 tomorrow morning (the nurse failed to inquire how the patient was doing at this time); and At 12:10 PM, the patient responded “KK”. Review of the medical record beginning on 06/03/2024, showed no nursing notes and/or coordination note entries between 05/16/2024 and 05/20/2024 regarding the patient’s report of abnormal symptoms via texting to RN-A until 05/20/2024, when the nurse made a visit to the patient. During an interview on 06/03/2024, at 12:35 PM, the administrator stated that patients are supposed to call the office. Sometimes the staff do not give patients their phone number, but the patients had it from caller ID (identification). Texting is not the preferred mode of communication, but with some clients it is their preferred mode. The clinicians can answer the patient’s texts. The clinicians should document the texted information in a coordination note. (it should be noted that in the text exchange between the patient and the home health nurse, RN-A failed to inform the patient to call the office) Review of RN-A’s visit note dated 05/20/2024, the patient reported a non-injury fall over the weekend and felt feverish two nights ago. The patient had a knot the size of baseball to the vaginal area that broke open over the weekend with foul odor and drainage. RN-A spoke with the NP’s medical assistant and reported abnormal findings and scheduled an appointment at 2:00 PM tomorrow (05/21/2024). RN-A discussed with patient the dangers of infection that may not be treated right away. The patient discussed with the patient's caregiver and decided to go to the emergency room on 05/20/2024 for evaluation. Review of the hospital record dated 05/20/2024, showed in part that the patient presented to the emergency department (ED) at 11:08 AM, for a wound check with concerns for a necrotic (dead tissue) in the vulva (genitalia). The patient had a vaginal cyst that erupted over the weekend. The patient had a large necrotic area, approximately 4 x 6 centimeters (cm) of necrosis on the vulva with pus drainage. The patient was alert to person, place, and time. The radiology report showed the right side of the mons pubis (an area of fatty tissue that covers the pubic bone) concerning for necrotizing fasciitis. Urgent surgical consultation is recommended. The critical care notes showed critical care was necessary to treat or prevent imminent (immediate) or life-threatening deterioration of the following conditions: sepsis. The primary diagnosis was necrotizing fasciitis. General surgery was emergently consulted in the ED. The patient was emergently taken to the operating room for debridement (removal of dead tissue) and will be taken back tomorrow for further debridement. Other diagnoses included severe sepsis with septic shock. During an interview on 06/05/2024, beginning at 12:27 PM, RN-A stated that: He/she typically communicated with patients through phone calls. They also have the on-call number in their folders; He/she used a google phone app tied to his/her personal phone number; Patients do text me. I don’t tell them to text me. If they text, I will call and talk to them and have them call the on-call number. If there’s an issue, I usually tell them to call the on-call number. I also tell them if they can’t get me try the on-call number. If I’m not on call, I usually don’t have my phone on me.; He/she worked on 05/16/2024 and 05/17/2024. The patient texted him/her on 05/16/2024 at 7:43 PM that he/she fell, nothing hurt, but elbow and butt sore. I responded on 05/18/2024, at 6:04 PM; When asked why he/she had not responded before, he/she stated that he/she may have tried to call. The nurse looked at his/her call log and said he/she did not call. It was unusual for him/her not to respond. It was over a weekend. The calls go over an app on his/her phone. He/she did not have an answer for that; He/she usually documented texted concerns from patients in a narrative or at the next visit usually at the time it occurred, but he/she did not this time; He/she didn’t see her or call on-call because the patient told him/her that he/she wanted to wait until Monday. I should have told her to go to the hospital right away; When asked if he/she asked the patient how he/she was doing on Sunday (05/19/2024), the nurse responded “No”; On 05/20/2024 he/she was going to assess the area, but when the patient stood up, the patient needed to go to the bathroom. While the patient was in the bathroom, the in-home caregiver came in and stated that the patient needed to go to the hospital. RN-A said I know, but he/she does not want to go. The patient liked things his/her way; and He/she called the NP’s medical assistant while the patient was in the bathroom. The patient came out and sat in a chair. I told him/her what an infection could lead to. I told the patient he/she needed to go to the hospital, and the caregiver encouraged that he/she needed to go. The appointment was made with the NP in case he/she didn’t go the hospital. The caregiver called the ambulance. He/she did not wait for the ambulance to arrive. During an interview on 06/06/2024, beginning at 9:20 AM, Patient #1 stated that: The nurse would text to let me know when he/she was coming for visits; The nurse did not tell him/her to call the on-call number after hours or to call the office if he/she needed something on the days the nurse was not there; He/she thought the first text was on Thursday (05/18/2024), and thought it was about having a fever but wasn’t sure; Regarding the text that he/she did not have a doctor until June 5, the patient stated that he/she saw the NP, but thought he/she needed an MD (medical doctor) due to his/her history of back surgery. He/she did not remember the fall; In reference to the text on 05/18/2024, at 4:48 PM, Monday was the time the nurse wanted to do my leg wraps; He/she did not remember Saturday. He/she did not think the nurse told him/her to call the on-call number or offer to call on-call or come out. When asked if he/she would have accepted a nurse visit before 05/20/2024, the patient stated, “Oh hell yeah”; When asked about the non-sensical texts, the patient stated that with the state my head was in, he/she did not know what they were about. He/she did not remember what getting ahold of somebody in the morning was in reference to; and When asked if the nurse told him/her to seek medical attention or go to the emergency room (ER), the patient stated that he/she thought the nurse just recommended to schedule a doctor’s appointment. He/she did not remember the nurse talking to him/her about going to the ER before his/her caregiver got there. During an interview with the NP’s medical assistant (MA) on 06/06/2024, beginning at 1:15 PM, the MA stated that: If the patient reported a fall and fever they would expect the home health nurse to make note of it and call to let them know. If needed, they would call and speak to the patient; When asked about the non-sensical texts, the MA stated that they may have thought the patient had a urinary tract infection; They were not informed of any issues by the nurse until 5/20/2024; If the patient reported a large, infected area, that took up the whole right side of the genitalia and made them want to scream every time they sat down, they would expect the nurse to visualize the area and call them; They had 24/7 availability and depending on what was reported, they would instruct the nurse or the patient on what to do; On 5/20/2024, the nurse reported the patient had an open wound with foul odor. The nurse did not report a size. When the NP saw the picture of the area, he/she stated that if he/she had known the area was that bad, he/she would have immediately sent the patient to the ER;; and The patient was good to message them, but there were no previous notes. They did not know about area until 5/20/2024. During an interview on 06/06/2024, beginning at 4:25 PM, RN-A stated that: Regarding the text on 05/18/2024, at 4:48 PM, he/she did not know, but assumed the statement about Monday would be good, was about the regular visit on Monday; He/she did not know what the text regarding not having a doctor referred to; The patient saw an NP, and they have an after-hours number; When asked whether the non-sensical texts on 05/18/2024, at 6:18 PM and 6:22 PM, made him/her think something was going on with the patient, RN-A stated that he/she did not necessarily think something was seriously wrong at the time; Regarding the text on 05/18/2024, at 6:24 PM and 6:25 PM, about getting ahold of someone in the morning, the nurse stated that he/she was clearly confused on the day and thinking the next day was Monday. The patient referenced it would be okay on Monday (05/20/2024); and Regarding his/her text on 05/18/2024, at 6:04 PM, when he/she questioned if the patient had an infection, and the patient reported a large, infected area that was very painful should have prompted an immediate evaluation, a visit by a nurse, or to be advised to go to the ER, RN A stated “Yes, I see that now looking back”. During an interview on 06/10/2024, beginning at 3:10 PM, the administrator stated that when the patient first texted, RN-A should have called the patient, reached out to on-call staff, or told the patient if they were not working, that he/she needed to call the on-call number. It was not appropriate to respond via texting. The nurse should have made a visit or arranged a visit. Either way, the patient needed to be seen by a nurse. RECORD/PATIENT#2: Review of the record showed the patient was admitted to service on 03/12/2024. Diagnoses included hypertensive heart disease (heart problems caused by long term high blood pressure), heart failure (a condition where the heart does not pump blood as well as it should), and diabetes mellitus. Review of the hospital discharge dated 04/02/2024, included wound care, if applicable, keep wound clean and dry. The instructions did not specify what procedure (s) the patient underwent. Review of the resumption of care (ROC, after hospitalization) orders dated 04/04/2024, included that the skilled nurse (SN) would assess and monitor the right incision (did not include location other than right) each visit. The orders included that the SN would instruct on incision care (failed to specify what incision care). Review of the nursing ROC assessment dated 04/04/2024, showed the patient had at least one (observable) surgical wound. The patient had an active wound that was newly epithelialized (healing). The assessment failed to include what the incision was from, location, measurements, whether incision care was provided or needed, or clarification with the physician regarding incision care of the wound. Review of a nursing visit note report dated 04/11/2024, the nurse documented he/she provided education including skin integrity/prevention of pressure ulcers, rotate position every two hours, turn in bed at night, keep area clean and dry (failed to document what area), and be mindful of any soreness and report for an assessment. He/she assessed the surgical incision (failed to indicate where the incision was) which was fully epithelialized (healed). During an interview on 06/04/2024, beginning at 12:00 (noon) with the administrator and clinical manager (CM)-B, CM-B stated that the nurses usually documented wound assessments and measurements in the wound care section. He/she would look for more information regarding the incision and incision care. During an interview on 06/05/2024, at 4:20 PM, the associate director stated that the hospital referral for the 04/04/2024, ROC showed the patient had a heart catheterization (a tube is inserted into a blood vessel in your groin or arm to the arteries of your heart) on 03/28/2024. The assessment of the surgical incision should have been much clearer. He/she did not see where the nurse clarified with the physician the order for incision care on the plan of care (POC). He/she did not see the heart catheterization procedure on the POC. The only diagnosis he/she saw that would go with the heart catheterization was atherosclerosis (a build-up of plaque on the artery walls). RECORD/PATIENT #3: Review of the record showed the patient was admitted to service on 05/01/2024. The primary diagnosis was atrial fibrillation (an irregular heartbeat). Review of the nursing start of care assessment dated 05/01/2024, showed under the section for cardiovascular (pertaining to the heart) assessment, the nurse documented fainting/dizziness. The narrative section included that the patient complained of dizziness. The assessment failed to include whether this was a new symptom, how often it occurred, and/or when it occurred, extent, duration, etc. The nurse documented he/she contacted the physician for clarification of medication discrepancies/abnormal assessment findings/approval of the plan of care (POC). The physician’s office verified medications, gave verbal approval for a physical therapy evaluation, and blood glucose parameters. The nurse failed to specifically document whether the patient’s dizziness was discussed. During an interview on 06/04/2024, beginning at 12:00 (noon), with the administrator and CM-B, CM-B stated that the patient was hospitalized with pneumonia on 05/07/2024. CM-B stated that the nurse probably should have documented more about the dizziness, and that the abnormal assessment findings probably needed to be a little more specific. He/she would expect the nurse to report the dizziness to the physician. The nurse documented noteworthy findings in the narrative then contacted the physician. He/she did not see specifically where the dizziness was reported. He/she would it assume the abnormal findings included all the above narrative.

Eligible training/competency evaluation orgs. CFR(s): 484.80(f) A home health aide training program and competency evaluation program may be offered by any organization except by an HHA that, within the previous 2 years: (1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or (2) Permitted an individual who does not meet the definition of a "qualified home health aide" as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or (3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or (4) Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or (5) Was found to have compliance deficiencies that endangered the health and safety of the HHA's patients, and had temporary management appointed to oversee the management of the HHA; or (6) Had all or part of its Medicare payments suspended; or (7) Was found under any federal or state law to have: (i) Had its participation in the Medicare program terminated; or (ii) Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or (iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or (iv) Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA's patients; or (v) Been closed, or had its patients transferred by the state; or (vi) Been excluded from participating in federal health care programs or debarred from participating in any government program. This STANDARD is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with one Condition of Participation: §484.75 Skilled professional services, the home health provider may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 06/13/2026.

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 policy review, record review, and interview, the home health provider failed to ensure staff documented all communication with the patient and failed to complete a comprehensive occurrence report in one of five records reviewed (Record/Patient #1). This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the provider's policy titled, "Chart Data Requirements," revised 10/23/2023, showed in part that follow-up assessments are completed in the electronic medical record (EMR) and these include any change in the client condition reflected on nurse's notes/clinical notes, and the fall investigation form. Clinical documentation is completed in the EMR and should include ongoing documentation of identified problems, any changes in client status, and documentation of client and caregiver education. Review of the provider's policy titled, "Incident Reporting and Documentation," revised 08/31/2021, showed in part that employees are instructed during the orientation process that it is mandatory to report all incidents, including adverse events or serious events, to their supervisors immediately. An incident is defined as any occurrence that is not consistent with the routine delivery of care. Clients are told at the time of admission what procedure to follow should they need to report any problems they are having. Reportable incidents include a change in client condition. All incidents must be reported as soon as possible, but not more than 24 hours after learning of a potential incident. All client related incidents will be documented the applicable electronic documentation system and centralized reporting system. Review of a form titled “Code of Ethical Behavior,” and signed by RN A on 09/20/2024, included in part that the employee will: - Not fail to report an incident or injury occurring to the client while on duty and whether medical attention was or was not needed; - Report accidents or injuries occurring in the absence of staff and reported by the client or client’s family. This should be reported to your supervisor as soon as possible; and - Obey established policies, guidelines, and other written policies. RECORD/PATIENT #1: Review of the record showed the patient was admitted to service on 04/02/2024. Diagnoses included acute pancreatitis (an inflammation of the organ (pancreas), type 2 diabetes mellitus (a group of diseases that results in too much sugar in the blood), and non-pressure chronic ulcer of the left lower leg (a skin ulceration due to poor circulation). Review of text messages printed by the provider from RN-A's phone showed on 05/16/2024, the patient texted RN-A regarding abnormal symptoms he/she was had, and the patient and RN-A texted back and forth on 05/18/2024 and 05/19/2024. Review of the medical record beginning on 06/03/2024, showed no nursing notes and/or coordination note entries between 05/16/2024 and 05/20/2024 regarding the patient’s report via texting of abnormal symptoms to RN-A until 05/20/2024, when the nurse made a visit to the patient. Review of RN-A’s visit note dated 5/20/2024, the patient reported a non-injury fall over the weekend and felt feverish two nights ago. The patient had a knot the size of baseball to the vaginal area that broke open over the weekend with foul odor and drainage. RN-A spoke with the NP’s (nurse practitioner) medical assistant and reported abnormal findings and scheduled an appointment at 2:00 PM tomorrow (05/21/2024). RN-A discussed with patient the dangers of infection that may not be treated right away. The patient discussed with the caregiver and decided to go to the emergency room today for evaluation. Review of a client occurrence reports dated 05/20/2024, showed the nature of the occurrence was a fall. The description of the occurrence showed on 05/202024, at 9:47 AM, reported to the NP’s office. The report failed to include any other information related to RN-A’s nursing visit on 05/20/2024, or that the patient had went to the hospital emergency department regarding his/her symptoms. During an interview on 06/03/2024, at 12:35 PM, the administrator stated that patients are supposed to call the office. Sometimes the staff do not give patients their phone number, but the patients obtain the number from caller ID (identification). Texting is not the preferred mode of communication, but with some clients it is their preferred mode. The clinicians can answer the patient’s texts. The clinicians should document the texted information in a coordination note. During an interview on 06/05/2024, beginning at 12:27 PM, with RN-A and the administrator, RN A stated that he/she usually documented texted concerns from patients in a narrative, coordination note, or at the next visit. He/she usually documented the notes at the time it occurred, but he/she did not this time. The administrator stated that the occurrence report should have been documented by RN-A in a comprehensive report.

A partial extended survey for Medicare recertification for the home health provider was completed on 11/15/2023. The provider had 559 current patients. The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 11/15/2023. One standard level deficiency was identified.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on policy review, employee file review, and interview the home health provider failed to ensure one employee received emergency preparedness training during orientation in one of six employee files reviewed (Employee #6). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Emergency Management Program and Plan-Home Health, Medicare Certified Home Care and Hospice Offices,” revised 03/16/2020, showed in part, that all field employees and contractors must complete emergency training upon hire and every two years. Training and demonstration must be documented. EMPLOYEE #6: Review of the employee file showed: - Date of hire: 04/24/2023; and - No record of emergency preparedness training at orientation. During an interview on 11/15/2023, at 9:04 AM, the director of clinical operations stated that employees should have emergency preparedness training within their first 90 days during orientation. During an interview on 11/15/2023, at 10:22 AM, the director of clinical operations stated that he/she could not find proof the employee had emergency preparedness training during orientation.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure the initial assessment visit occurred within 48 hours of referral in one of five full records reviewed (Record/Patient #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's policy titled, "Admission Criteria and Procedure - Medicare Certified Offices," dated 08/14/2023 showed the initial assessment must be completed within 48 hours of referral. RECORD/PATIENT #3: Review of the clinical showed: -An order dated 09/22/2023 to admit the patient to home health services with a primary diagnosis of Alzheimer's disease; and -The initial assessment was completed on 09/25/2023, 3 days after the start of care order. During an interview on 11/15/2023 at 2:10 PM, the home health director of clinical operations stated that he/she had nothing to provide regarding the late start of care assessment.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview the home health provider failed to ensure the comprehensive assessment accurately reflected the patient's status in one of five full records reviewed (Record/Patient #4). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Client Assessment and Reassessment,” revised 07/05/2021, showed in part: - A comprehensive assessment gives registered nurses (RN) and therapists insight into a client’s status through observation, measurement of vital signs, and the client’s self- reported symptoms; - It includes the client’s medical history and diagnoses and a complete physical assessment; - The data collected is used to determine the client’s need for care and services to be provided, the need for further assessments, and the creation of the plan of care; and - Review of all medical equipment, resources and supplies in the home relevant to services provided. Review of the provider’s policy titled, “Chart Data Requirements and Format – Home Health Practice,” revised 10/23/2023, showed in part that the OASIS (Outcome Assessment and Information Set)-Comprehensive Adult Nursing Assessment included physical assessment, pain effects on sleep, therapy and/or activities of daily living. Review of the provider’s policy titled, “Pain Assessment and Management,” revised 07/05/2023, showed in part: - Pain is assessed for all clients at admission by a registered nurse (RN) or therapist; - In general, a client’s pain level is assessed using a 0 to 10 scale (with 0 equivalent to no pain and 10 representing the worst pain ever experienced); - When a client reports the presence of pain (1 – 10) or a recent history of pain, the nurse or therapist will assess and document other factors as appropriate to determine if pain is a problem or requires intervention. The areas to be assessed may include any or all of the following: *Origin (what is the source of the pain); *Location; *Severity (Is it continuous or intermittent); *Are there any associated symptoms; *Any factors that make the pain worse; *What helps to relieve the pain; and *What are the current pain relief methods used and are they effective. RECORD/PATIENT #4: Review of the referral information dated 10/19/2023, showed: - The patient was hospitalized from 10/14/2023 to 10/19/2023 for bacteremia (bacteria in the bloodstream) due to klebsiella pneumonia (a bacteria found in the gut) due to pneumonia (lung infection) and a UTI (urinary tract infection). The primary reason for home health care included in part, sacroiliac (low back and buttocks) pain, obstructive sleep apnea on CPAP (continuous positive airway pressure, a machine that uses mild air pressure to keep the airways open while sleeping), and type 2 diabetes mellitus (a group of diseases that results in too much sugar in the blood); - Use blood glucose meter to check blood sugars up to three times a day; and - Insulin (injectable medication used to lower blood sugar) lispro (fast acting insulin) per sliding scale (the amount of insulin administered is dependent on the blood sugar reading) three times daily. Review of the initial comprehensive assessment dated 10/20/2023, showed: - The patient had pain rated at a level of four that interfered with activity, occasionally interfered with sleep, therapy activities, and day to day activities; and - Blood sugars were checked daily and ranged from 100 to 200. Review of the initial comprehensive assessment, dated 10/20/2023, failed to: - Include the location of the pain, the description of the pain, what made the pain worse, and what interventions the patient used for the pain relief and the effectiveness of those interventions; - Include an assessment related to the use of the CPAP machine; - Include an assessment of lung sounds; - Include an assessment of how often the patient was checking his/her blood sugars and if he/she was taking the sliding scale insulin as ordered; and - Include if the patient had a history of issues with hypoglycemia (low blood sugar) or hyperglycemia (high blood sugars). During an interview on 11/15/2023, beginning at 9:10 AM, the director of clinical operations stated that he/she would expect the CPAP to be addressed. The pain assessment should include the location, what the patient was taking for pain, its effectiveness, and a description of the pain. Lung sounds should be included in the assessment. The assessment should include the patient’s history of low or high blood sugars and education of signs and symptoms to watch for. During an interview on 11/15/2023, beginning at 1:30 PM, the director of clinical operations stated that he/she did not find information regarding the patient’s CPAP in the comprehensive assessment. Their computer system was not set up to include all the components of the pain assessment but would expect staff to document all the components of the pain assessment. Their computer system did not have an assessment for lung sounds in the comprehensive assessment but would expect staff to have added lung sounds to their assessment.

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, record review, home visit observation, and interview the home health provider failed to ensure staff performed a complete/accurate medication reconciliation and maintained an accurate/updated medication profile in four of five full records reviewed (Records/Patients #1, #2, #4, and #5). This deficient practice has the potential to affect all the patients served by the provider. Findings included: Review of the provider’s policy titled, “Chart Data Requirements and Format – Home Health Practice,” revised 10/23/2023, showed in part: - All home health clients will have a medication list in the home; and - The medication profile is updated as changes occur. Review of the provider’s policy titled, “Client Assessment and Reassessment,” revised 07/05/2021, showed in part that client assessments and reassessments included current and past medication use and history, including allergies, potential adverse effects, drug reactions/interactions, significant side effects and duplicate drug therapy. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 12/20/2022, with a primary diagnosis of chronic ulcers of the right lower leg. The patient resided in his/her own home with the assistance of their spouse. During a home visit observation on 11/13/2023 at 1:00 PM, a review of the patient’s medications showed the provider’s medication profile failed to contain orders for nystatin cream ordered on 09/15/2023. The patient reported that he/she used the cream for excoriated areas. During an interview on 11/15/2023 at 10:53 AM, the director of clinical operations stated that the medications on the provider’s medication profile should contain the correct medications and they had already notified the physician of the updated medications. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 10/19/2023, with a primary diagnosis of fracture (break) of the left ulna (arm) and a laceration of the left lower leg secondary to a motor vehicle accident. The patient resided alone in a private residence. During a home visit observation on 11/15/2023 at 12:00 PM, a review of the patient’s medications showed: - The provider’s medication profile failed to contain the following medications found in the patient’s home: * Docusate sodium (a stool softener); * Tums (a medication used to treat heart burn); * Tylenol (a medication used to treat pain; * Vitamin D3 (a vitamin supplement); and - The provider’s medication profile contained an order for a Lidocaine 5% patch. The patient stated that he/she had never filled the prescription for the patch. During an interview on 11/15/2023 at 1:39 PM, the director of clinical operations stated that the medications on the provider’s medication profile should contain the correct medications and they had already notified the physician of the updated medications. RECORD/PATIENT #4: Review of the referral information dated 10/19/2023, showed in part, the patient was hospitalized from 10/14/2023 to 10/19/2023 for bacteremia (bacteria in the bloodstream) due to klebsiella pneumonia (a bacteria found in the gut) due to pneumonia (lung infection) and a UTI (urinary tract infection). The primary reason for home health care included in part, sacroiliac (low back and buttocks) pain, obstructive sleep apnea on CPAP (continuous positive airway pressure, a machine that uses mild air pressure to keep the airways open while sleeping), and type 2 diabetes mellitus (a group of diseases that results in too much sugar in the blood). Review of the hospital discharge medication list dated 10/19/2023, showed the following discrepancies with the home health provider’s medication profile: - The discharge medication list showed an order for acidophilus (lactobacillus, a probiotic to promote gut health), 25 million cell/100 milligrams (mg), take two tablets by mouth three times a day with meals. The provider’s medication profile failed to include this medication; - The discharge medication list showed an order for lactobacillus 10 billion cell, one capsule two times a day for seven days. The provider’s medication profile showed an order for lactobacillus 100 million cell granules packet three times a day with meals; - The discharge medication list showed an order for budesonide (a steroid medication to decrease inflammation) 0.5 mg/2 milliliters (ml) one vial per nebulizer (turns medication into a mist for inhalation) two times a day. The provider’s medication profile showed an order for budesonide 0.25 mg/2 ml two times a day; - The discharge medication list showed an order for health eyes oral (vision supplement) daily. The provider’s medication profile failed to include this medication; - The discharge medication list showed an order for atorvastin (Lipitor, reduces cholesterol) 40 mg (frequency not included). The provider’s medication profile showed an order dated 10/20/2023, for atorvastin 40 mg every night and an order dated 10/26/2023, for Lipitor 40 mg daily (this showed a duplicate medication); and - The discharge medication list showed an order for oxybutynin (used to treat overactive bladder) 5 mg every 8 hours as needed. The provider’s medication profile showed an order for oxybutynin 5 mg every eight hours. Review of the initial comprehensive assessment dated 10/20/2023, showed: - The nurse used the referral information and medications found in the home for the medication reconciliation; - The medications on the medication list matched those ordered; - No issues were found during the drug regimen review; - No discrepancies were noted; and - The physician was contacted for medication discrepancies (above showed no discrepancies) but failed to document what the medication discrepancies were. During an interview on 11/15/2023, beginning at 9:10 AM, the director of clinical operations stated that staff reconcile medications with the most recent medication list from the referral. In the home, they ask the patient to provide all medications and compare the home medications with the medication list. They would note any discrepancies and contact the physician for clarification. If discrepancies are found, staff should document the specific discrepancies. RECORD/PATIENT #5: Review of the clinical record showed the patient was admitted to home health services on 07/18/2023, with a primary diagnosis of non-pressure ulcer of the left heel and mid-foot with fat layer exposure and a secondary diagnosis of type 2 diabetes mellitus. Review of the client medication report, dated 11/13/2023, showed an order for 5 ml of Medihoney (an antibacterial wound treatment that contains honey) topical paste to be used daily. Review of the plan of care, dated 09/16/2023 - 11/14/2023, failed to show an order for Medihoney. During an interview on 11/15/2023 at 2:10 PM, the home health director of clinical operations stated that the Medihoney was a part of the previous wound care order, and he/she would have expected the order to be discontinued when the wound order changed.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview the home health provider failed to ensure the patient received nursing services as ordered on the plan of care and the physician was notified of the missed visit in one of seven records reviewed (Record/Patient #1). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Missed Visits/Hours,” last reviewed 03/24/2023, showed that the physician must be notified when the plan of care is altered due to few visits or hours of service being provided as ordered. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 12/20/2022. The primary diagnosis for the current certification period of 10/16/2023 to 12/14/2023 was chronic ulcers of the right lower leg. The patient resided in his/her own home with the assistance of his/her spouse. Review of the document titled, “Home Health Certification and Plan of Care,” with certification dates of 10/16/2023 to 12/14/2023 showed that the patient was to receive nursing visits for wound care three times per week on Monday, Wednesday, and Friday. Review of the nursing visit documentation showed the nurse failed to visit the patient on Wednesday, 10/18/2023, and visited the patient on Thursday, 10/19/2023. The clinical record failed to contain documentation the physician was notified regarding the missed nursing visit (10/18/2023). During an interview on 11/15/2023 at 10:53 AM, the director of clinical operations stated that they would have expected the physician to be notified of the missed visit.

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 policy review, record review, and interview, the home health provider failed to ensure the plan of care (POC), included all equipment required, patient-specific interventions, and goals for all pertinent diagnoses in two of five full records reviewed (Records/Patients #4 and #5). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's policy titled, "Client Plan of Care (POC)," dated 07/05/2021, showed in part, the following: - The POC would include statements of individualized client needs and problems, and -The individualized POC is based on the client's medical diagnosis, physician's order, comprehensive assessment, and client input. RECORD/PATIENT #4: Review of the referral information dated 10/19/2023, showed in part: - The patient was hospitalized from 10/14/2023 to 10/19/2023 for bacteremia (bacteria in the bloodstream) due to klebsiella pneumonia (a bacteria found in the gut) due to pneumonia (lung infection) and a UTI (urinary tract infection). The primary reason for home health care included in part, sacroiliac (low back and buttocks) pain, obstructive sleep apnea on CPAP (continuous positive airway pressure, a machine that uses mild air pressure to keep the airways open while sleeping), and type 2 diabetes mellitus (a group of diseases that results in too much sugar in the blood); - Use blood glucose meter to check blood sugars up to three times a day; and - Insulin (injectable medication used to lower blood sugar) lispro (fast acting insulin) per sliding scale (the amount of insulin administered is dependent on the blood sugar reading) three times daily. Contact the physician’s office of blood sugar readings greater than 250 or greater than 180 for two consecutive readings. Review of the initial comprehensive assessment dated 10/20/2023, failed to show: - An assessment related to the use of the CPAP machine; - An assessment of how often the patient was checking his/her blood sugars and if the patient was taking the sliding scale insulin as ordered; and - If the patient had history of hypoglycemia (low blood sugar) or hyperglycemia (high blood sugars). Review of the POC dated 10/20/2023, failed to show: - All equipment (CPAP machine); - Patient-specific interventions and goals regarding the CPAP machine; and - The correct intervention (patient-specific) for when to notify the physician regarding the patient’s blood sugars, in all sections of the POC (was documented in one section of the POC to notify the physician of blood glucose readings greater than 70 (should have said less than) or greater than 300 (order showed above 250 or above 180 for two consecutive readings). During an interview on 11/15/2023, beginning at 9:10 AM, the director of clinical operations stated that he/she would expect the CPAP to at least be included with the DME (durable medical equipment) information on the POC. Sometimes in their computer system if they chose CPAP, it showed oxygen supplies. He/she stated that the parameter to report blood sugars above 300 was not their policy. He/she would have expected the nurse to clarify the parameters with the physician and include those parameters on the POC. RECORD/PATIENT #5: Review of the clinical record showed the provider admitted the patient to service on 07/18/2023, with a primary diagnosis of a non-pressure ulcer of the left heel and mid-foot with fat layer exposure and a secondary diagnosis of type 2 diabetes mellitus. Review of the document titled, "Home Health Certification and Plan of Care," dated 09/16/2023 - 11/14/2023, showed the following: - Skilled nurse to perform wound care to the left heel; - Patient had glucometer listed in durable medical equipment (DME) list; and -The POC failed to include patient-specific interventions regarding diabetes and the use of the glucometer. During an interview on 11/15/2023 at 2:10 PM, the home health director of clinical operations stated that he/she would expect there to have been sugar monitoring in relation to wound healing.

A complaint investigation, 100440, was completed on 08/29/2023 at the home health provider. The provider had 501 current patients. The complaint is substantiated. One or more of the allegations reported are verified and standard deficiencies were cited that are related to the allegations being investigated.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on policy review, record review, and interviews the home health provider failed to ensure nursing services were provided in accordance with the providers policy and procedures in one of three records reviewed (Record/Patient #3). This deficient practice has the potential to affect all patients on service with the provider. Findings included: Review of the home health provider's undated policy titled, "Peripherally Inserted Central Catheter: Maintenance and Dressing Change," showed in part the following: "Inspect the catheter, the access site, and the surrounding skin, as well as the patient's arm, chest and neck area for signs of complications"; "Assess for signs of infection, including redness, swelling, inflammation, tenderness, or exudate; "Assess for catheter migration. Observe the external catheter length and compare it to the insertion record"; and "Notify the practitioner if complications are present". RECORD/PATIENT #3: Review of the plan of care, signed by a physician on 08/01/2023 showed: The patient was admitted to home health services on 07/26/2023 with a primary diagnosis of partial Intestinal obstruction; The home health nurse was ordered to change PICC line (PICC line –peripherally inserted central catheter inserted in the vein of the arm to a large vein above the heart) dressing weekly and PRN (as needed) for soilage or dislodgement using sterile technique; and The home health nurse was to observe and assess the PICC line, care of the infusion line, and to report complications of IV (intravenous) therapy. Review of the PICC insertion record, included in the home health admission intake documents showed that on 07/17/2023 a double lumen PICC was inserted into the patient's right upper arm. There was "0 cm (centimeters)" of external catheter present. Review of a nurse visit note, dated 07/28/2023, showed that the home health nurse (RN-C) changed the PICC dressing, assessed that 36.0 centimeters of exposed catheter was present from insertion site to the catheter hub. (This assessment indicates that the PICC had migrated 36.0 cm from the time of insertion). No redness or site complications were documented. Review of a nurse visit note, dated 07/31/2023, showed that the home health nurse changed the PICC dressing. The nurse failed to document assessment for PICC catheter migration. The nurse documented, "No signs and symptoms of infection at this time". Review of a nurse visit note, dated 08/01/2023, showed that the home health nurse (RN-B) assessed that 1.0 centimeter of exposed catheter from insertion site to catheter hub was present. (This assessment indicates that the PICC had migrated 1.0 cm from time of the insertion, or had been reinserted by unknown methods 35 cm since the 07/28/2023 visit). No redness or site complications were documented. "No problems noted with site". Review of a nurse visit note, dated 08/02/2023, showed that the home health nurse (RN-A) assessed that 5.0 centimeters of exposed catheter from insertion site to catheter hub was present. (This assessment indicates that the PICC had migrated 5.0 cm from the time of insertion, or been reinserted by unknown methods 30 cm since the 07/28/2023 visit). The nurse assessed redness under the "stat lock" (a securement device at the PICC insertion site). The patient reported "burning on the redness area". The nurse failed to notify the physician of the PICC surrounding skin redness, burning in the redness area, or PICC catheter migration. During interview with RN-B on 08/29/2023 at 9:50 AM, the nurse stated that he/she did not call the physician (practitioner) for any complications to the PICC. He/she was present during the 08/02/2023 visit when the site redness and burning was assessed, along with the PICC catheter migration. He/she was acting as a mentor/preceptor for RN-A during the 08/02/2023 visit. During an interview with the nurse clinical manager on 08/29/2023 at 4:30 PM, he/she stated that the nurse should have notified the physician regarding redness and burning of the skin surrounding the PICC insertion site, and should have notified the physician of the PICC catheter migration in accordance with agency policy.

A complaint investigation (62955) was completed on 05/25/2022 at the home health provider. The agency had 721 current patients. 273 current patients at the parent office in Springfield, 232 current patients at the branch office in Joplin, 97 current patients at the branch office in Monett and 119 current patients at the branch office in Lebanon. The complaint is substantiated. One or more of the allegations reported are verified and standard deficiencies were cited that are related to the allegations being investigated.

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, record review, and interview, the agency failed to ensure an accurate medication review and/or update of the patient’s medications was completed in two (Records/Patients #1, and #3) of three full charts reviewed. This deficient practice has the potential to adversely affect the accurate administration of medications to all the agency’s patients. RECORD/PATIENT #1: Review of the hospital discharge medication list, dated 01/25/2022, showed the following medications were ordered at discharge: - Azelastine (a medication used to help relieve allergy symptoms) 137 micrograms (mcg) per actuation (delivery of medication). 2 sprays in each nostril, as needed, for wheezing; - Benzonatate (a medication to treat cough) 200 milligrams (mg) by mouth 3 times daily; - Cholecalciferol (vitamin D3, a dietary supplement used to treat a vitamin D deficiency) 5,000 units, take 2 tablets by mouth daily for 1 month. Then 10,000 units on Monday, Wednesday, and Friday and 5,000 units the other four days of the week with a fat containing meal to improve absorption; - Clindamycin phosphate (a topical antibiotic) 1% lotion. Apply to affected area 2 times daily. Mix with econazole (used to treat fungal skin infections) cream and apply to underarm rash 2 times a day for 1 to 2 months; - Clonidine (a drug to treat high blood pressure) 0.1mg tablet by mouth 3 times daily as needed for systolic (top number) blood pressure over 180; - Dexamethasone (a steroid to relieve inflammation) 6 mg by mouth daily for 2 days; - Econazole (used to treat fungal skin infections) mix with clindamycin lotion and apply to underarm rash 2 times daily; - Hydroxyzine hydrochloride (an antihistamine used to treat allergies, skin rash, hives, and itching) 10 mg take 1 tablet my mouth 3 times daily, as needed; - Ipratropium-albuterol (a combination medication used to treat and prevent symptoms caused by ongoing lung disease) 0.5 mg-3 mg/3 milliliter (mL) solution for nebulization (a method of drug delivery in the form of a mist to be inhaled into the lungs). Take 3 mL by inhalation every 6 hours as needed for shortness of breath; - Ketoconazole (a drug to treat fungal infections) 2% cream, apply a thin coat twice a day until rash is gone. Then once a day for another week (does not specify where to apply); - Metoclopramide (a drug to treat nausea and vomiting) 10 mg, take one tablet by mouth 4 times daily before meals and at bedtime; and - Tramadol (a pain medication) 50 mg by mouth every 6 hours as needed for pain (note, in parenthesis, says patient is not taking). Review of the plan of care (POC), dated 01/26/2022 to 03/26/2022, showed: - The POC failed to include the listed discharge medications on the patient’s current medication list; - The POC did not include orders to discontinue the medications listed on the discharge medication list; Review of the client coordination note report, dated 01/26/2022, showed: - The patient is non-compliant with several medications upon assessment. Physician notified of this finding (note does not specify which medications); - Medications listed on the referral medication list but unable to locate in the patient’s home are dexamethasone, Tessalon (benzonatate), clonidine, Reglan (metoclopramide), and tramadol (the note does not mention other medications listed on discharge medication list); - The skilled nurse (SN) called and left message for the physician; - The SN obtained verbal clarification of medications. No further follow-up needed at this time; and - The note failed to describe the details of the verbal clarification on medications, including which medications were discussed, and whether they were to be continued or discontinued. During an interview on 05/25/2022 at 10:55 AM, Administrator B stated that he/she agreed that, regardless of the patient’s compliance, the medications should have been added to the plan of care or an order should have been obtained to discontinue the medications. During an interview on 05/25/2022 at 12:17 PM, Administrator A stated that it would be nice if the clinicians would list every medication they discuss in their notes. They have told them to list them. He/she would expect documentation that an order was received to continue or discontinue the medication. He/she stated that the clinicians usually put the medications on the plan of care then get the order to discontinue. Findings included: Review of the agency’s policy titled, “Medication Management” dated 04/05/21 showed, in part: - The agency sees that the medication regime prescribed by the physician for patients is followed; - Problems or changes in condition related to medications are identified, communicated to the physician, and modifications are made as prescribed; - Medication management involves multiple components, including medication reconciliation, medication review, medication validation, patient education, medication set-up/administration, safe storage and disposal and response to adverse reactions; - Medication reconciliation will be completed at SOC (start of care), ROC (resumption of care), SCIC (significant change in condition) and anytime a patient is seen in the ED (emergency department); - The admitting clinician initiates the patient’s medication profile upon the SOC visit. This is completed by visualizing all medications within the patient’s home comparing it to the most recent medication list contained within the referral documentation. This includes prescription, over the counter, and herbal supplements the patient is taking; - Any discrepancies found during the medication reconciliation will be documented in the EMR (electronic medical record) and the physician will be notified. If SOC clinician is unable to speak with the physician, it will be the responsibility of the clinical director to follow up on any discrepancies identified and documented within the EMR; - Any discrepancies which are identified during the reconciliation are brought to the attention of the attending physician immediately. This includes patient noncompliance. Documentation of this communication will be documented in the clinical record; - Medication reviews are completed during each subsequent visit. During the medication review process the clinician reviews medications on the medication profile within the EMR with the patient and/or patient caregiver and validates whether any changes have been made; - Any new medications should be entered using a physician order; - Physician response regarding any changes in the medication regime is requested within 24 hours; and - If there is no response within 24 hours, at least two additional requests are sent. Review of the agency’s policy titled, “Physician’s Orders” dated 12.11.17 showed, in part: - An order or prescription is verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, or the direct transcription of a verbal order; - Orders are documented and verified (approved) electronically or on a form provided by the agency, dated and signed by the professional receiving the order; and - When the signed order form is returned to the agency, it is made part of the electronic medical record as an attachment and labeled appropriately for reference. RECORD/PATIENT #1 Vikki RECORD/PATIENT #3 Review of the medication list at discharge from the hospital to home dated 02/17/2022 12:25 PM showed, in part: - Lactulose 20 gram/30ml (milliliter) take 30 ml by mouth two times daily (used to treat constipation and/or used to treat or prevent complications of liver disease by decreasing the amount of ammonia in the blood) ; - Levofloxacin 500mg (milligram) take one tablet by mouth daily (used to treat infections); - Multivitamin with folic acid 400mcg (microgram) tablet take one tablet by mouth daily (vitamin supplement); and - Thiamine mononitrate, vitamin B1 (thiamine) 100mg take one tablet by mouth daily (vitamin supplement). Review of the POC (plan of care) dated 02/22/2022 through 04/22/2022 failed to show the lactulose, levofloxacin, multivitamin with folic acid, or thiamine mononitrate listed. Review of the POC (plan of care) dated 02/22/2022 through 04/22/2022 showed gentamicin 0.3% eye drops 2 drops every four hours (no directions of which eye or if both) take for five days (used to treat eye infections). Review of the medication list at discharge from the hospital to home dated 02/17/2022 12:25 PM failed to list gentamicin eye drops. Review of a client coordination noted dated 02/22/2022 showed: - Note type: Clinically significant medication issue; - Medications listed on the referral medication list but unable to locate in the patient’s home [include full order]: *Lactulose 20gm/30ml, take 30ml by mouth twice daily for ammonia reducer. (Patient stating not taking due to giving her diarrhea, explained it’s an ammonia reducer. Patient refuses to take it); *Multivitamin with folic acid 400mcg, take one tablet by mouth every day for supplement; and *Thiamine mononitrate 100mg, take one tablet by mouth every day for 14 days for Vitamin B deficiency. Was medication follow-up completed by midnight the next calendar day? Yes (The gentamicin eye drops nor the levofloxacin were mentioned) Review of a medical record coordination note report dated 02/22/2022 showed: - Note type- HH (home health) SOC admit; - Medications found in the patient’s home but not identified on referral medication list [include full order]: all medications verified through MA (medical assistant) at the PCP (primary care physician) office at 1633; - Medications listed on the referral medication list but unable to locate in the patient’s home [include full order]: * Lactulose 20gm/30ml, take 30ml by mouth twice daily for ammonia reducer. (Patient stating not taking due to giving her diarrhea, explained it’s an ammonia reducer. Patient refuses to take it); *Multivitamin with folic acid 400mcg, take one tablet by mouth every day for supplement; and *Thiamine mononitrate 100mg, take one tablet by mouth every day for 14 days for Vitamin B deficiency. - Were medication discrepancies or any additional abnormal findings clarified by SOC clinician or is additional follow up needed by the office: Spoke with MA at PCP office at 1633. Informed him/her of vitamins have not been gotten yet due to waiting on money. (No mention of lactulose, levofloxacin or gentamicin) MA verbalized understanding. Review of the clinical record failed to show physician medication clarification orders for discontinuing the lactulose, multivitamin with folic acid, or thiamine mononitrate. It also failed to show physician medication clarification orders for initiating the gentamicin eye drops. During an interview on 05/25/2022 at 12:17 AM, Administrator A stated that for medication reconciliation/discrepancies on admission some sort of order or documentation showing whether the medication/s was to be continued or discontinued would be expected. During an interview on 05/25/2022 at 10:55 AM, Administrator B stated that there should be an order discontinue or keep medication active for medication reconciliation/discrepancies on admission.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to notify/communicate with the physician regarding patient care changes in one (Record/Patient #3) of three full records reviewed. This deficient practice has the potential to adversely affect the care of all patients served by the agency. Findings included: Review of the agency’s policy titled, “Case Management/Coordination of Care,” dated 12.11.17, showed in part: - Purpose: To assure quality and coordinated care for home care patients by providing guidelines for case management; - The case manager will: * Regularly evaluate and re-evaluate patient status; * Initiate, develop, implement, and revise the patient’s plan of care (POC), integrating orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient; * Coordinate the total POC and conference with other disciplines involved in the case, including all physicians involved in the POC; * Ensure ongoing coordination of care including all services provided directly or under arrangement/contract to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines; * Report signs/symptoms signaling a change in patient condition to the patient’s physician; ** Changes in condition identified by a visiting clinician should be reported to the physician by that clinician and Case Manager notified; and ** All changes in patient condition that result in an update to the plan of care will be reported to all physicians involved in the POC as well as the patient/caregiver and representative (if any). - The visiting clinician will be responsible for contacting the physician when assessment reveals a change in condition or to request additional orders as needed to maintain patient status. Report of all physician contact must be given to Case Manager as well as documented in the clinical record. Review of the agency’s undated policy titled “Physician Follow Up Guidelines,” showed: - Objective: Identify process for physician follow up to ensure proper care coordination; - Process to ensure objective is met: * Clinician identifies issue in field that requires follow up or communication with physician; * Clinician contacts physician’s office by phone and communications issue/needs and requests follow up call to be returned to the clinical director in the Home Health office not clinician’s personal phone; * Clinician completes a clinical coordination note detailing issue/need which populates the review coordination notes tab in workflow and notifies clinical director by phone of issue/need; * The clinical director reviews the clinical coordination note and follows up with the physician’s office if communication is not received daily from physician’s office; * When the clinical directors resolve the issue/need with the physician’s office, they place orders, communicate with case manager and team members, communicate with the patient/caregiver, and make changes to the plan of care and schedule as needed; * The clinical director will enter follow up comments daily to the clinical coordination note in review coordination notes workflow tab until the issue/need is resolved; and * Once the issue/need is resolved, the clinical coordination note will be staged completed in the review coordination notes workflow tab. Review of the agency’s policy titled “Plan of Care”, dated 12.11.17, showed in part: - The plan of care will be reviewed and revised as frequently as the patient’s condition or needs require, but no less frequently that once every 60 days; - The plan of care will be individualized and focus on identified problems, goals, and interventions which will be specific to the patient and family/caregiver; - The case manager will coordinate the total plan of care and conference with other disciplines involved in the case; - The plan of care will contain any additional items identified by the agency or the physician for inclusion in the plan of care; - The agency must promptly alert the relevant physician to any changes in the patient’s condition or needs that suggest the outcomes are not being achieved and/or that the plan of care should be altered; - A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA (home health agency) and patients in the plan of care; and - Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians issuing orders for the HHA plan of care. RECORD/PATIENT #3: Review of POC, dated 02/22/2022 through 04/22/2022 showed: - The patient was admitted with orders for SN (skilled nursing), PT (physical therapy), and OT (occupational therapy); - Diagnoses included, but not limited to, Calculus of gallbladder w/o (without) cholecystitis w/o obstruction (gallstones without inflammation of gallbladder or obstruction), nicotine dependence- cigarettes-uncomplicated, thrombocytopenia (low platelet count), alcohol abuse-uncomplicated, morbid (severe) obesity due to excess calories, personal history of other infectious and parasitic diseases (history of hepatitis C-an infection caused by a virus that attacks the liver and leads to inflammation), and personal history of covid-19 (an infectious disease caused by the SARS-CoV-2 virus); - Skilled Nurse for observation/assessment of pain, effectiveness of pain management regimen and skilled teaching related to pain management and to report to physician with increased pain level over 8 to minimize complications; - Skilled nurse to assess/evaluate co-morbid conditions including, but not limited to, jaundice non neonatal, hepatitis C, hepatic encephalopathy, cholelithiasis, tobacco abuse, alcohol abuse, altered mental status, irritable bowel disease and other conditions that present themselves during the course of this episode and identify changes and intervene to minimize complications; and - Pain medication failed to be listed on the POC. Review of the visit note report dated 02/22/2022, visit type- RN OASIS admission showed: - Patient pain score of 9; - Patient reported goal pain score (0-10) of 6; - Indicate location of pain: abdomen; - How does patient describe the character of pain: cramping and pressure; - Indicate what relieves pain: change of weight bearing, movement/exercise, positioning, rest/sleep; - Indicate what makes pain worse: weight bearing, activity, movement, exercise, certain positions, varies according to time of day; - Is the patient receiving routine pain medications: no; - Frequency of pain interfering with patient’s activity or movement marked 4- all of the time; - Indicate how often breakthrough pain medication is needed for pain: never; - Was the medication reconciliation done during the visit: yes; - Did a complete drug regimen review identify potential clinically significant medication issues marked 1-yes- issues found during review; - Did the agency contact a physician (or physician designee) by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potential clinically significant medication issues marked -1-yes; and - Medication compliance reviewed: patient/caregiver compliant with all medication administration. Further review of the clinical record failed to show communication with the physician regarding the patient’s complaint of pain rated a nine or the patient’s pain goal of a 6 on admission (02/22/2022). Review of the SN visit notes showed pain ratings varying from 0-5 and the patient’s goal ranging from 0-5. Review of a physician order dated 3/8/2022 11:30 AM, order type: add on discipline, showed occupational therapist to provide instruction regarding pain control methodologies including pharmacological and non-pharmacological methods. Occupational therapist for observation, assessment of pain, and effectiveness of pain management. Occupational therapist to intervene with increased pain of 7 or greater on numeric pain scale to minimize complications. Therapy in collaboration with skilled nurse to review medication profile and reconcile of medications as needed. Therapy may instruct and reinforce medication teaching related to use of medications to treat disease processes. Review of a physician order dated 3/8/2022 1:27 PM, order type: add on discipline, showed physical therapist to provide instruction regarding pain control including pharmacological and non-pharmacological methods. Physical therapist to report to physician with increased pain level over 8/10 to minimize complications. Physical therapy in collaboration with skilled nurse to review medication profile and reconcile of medications as needed. Physical therapy may instruct and reinforce medication teaching related to use of medications to treat disease processes. Review of the PT notes, dated 03/08/2022 through 03/15/2022, showed pain ratings varying from 0-6 and the patient’s goal always a 0. Review of the OT notes, dated 03/08/2022 through 03/15/2022, showed pain ratings varying from 5-7 and the patient’s goal ranging from 0-5. The clinical record failed to show any clarification with the physician with regards to the POC showing to report to the physician with increased pain level over 8, versus the patient’s goal varying from 0 to 6, versus the OT to intervene with increased pain over 7 and no pain medications were ordered. Review of the client coordination note report dated 02/22/2022 showed: - 64 year old patient admitted to home health with diagnosis of hepatic failure (liver failure). Patient was referred for a local hospital for SN monitoring, PT for strengthening and endurance and OT for improvement of ADLs (activities of daily living); and - Focus of care during this episode diagnosis education and monitoring. Patient has a past medical history of jaundice non-neonatal (a liver condition that causes yellowing of the skin), hepatitis C, hepatic encephalopathy (loss of brain function when a damaged liver doesn't remove toxins from the blood), pneumonia, degenerative disc disease (discs between vertebrae lose cushioning), cholelithiasis, tobacco abuse, alcohol abuse, altered mental status, morbid obesity, irritable bowel disease, neck surgery due to spinal stenosis (narrowing of the spinal canal), and partial hysterectomy (removal of a uterus leaving cervix intact). SN visit noted dated 02/28/2022 showed: - The patient reports nausea, vomiting, and diarrhea the past two days; and - The patient reports “I have trouble with my gall bladder, not sure why the Doctor does not remove it”. The clinical record showed the physician failed to be contacted regarding the nausea, vomiting and diarrhea. SN visit noted dated 03/08/2022 showed, in part, the following narrative: Upon arrival to the home, was called into the home by patient. Patient lying in bed and refuses to get out of bed stating that she just laid back down. The PT had told this nurse that she could not get the patient out of bed during her visit either. Informed patient again that if staff cannot get patient out of bed the she would be discharged for non-compliance. Patient possibly taking medications not prescribed to her. Patient slurring words and some words non-comprehensive. Patient reports taking some liquid medication that has made her loopy. Patient with complaints of pain rating at 3/10 in stomach. Patient’s husband or daughter in law sets up patient’s medication and patient is able to take medications independently with no difficulty. The clinical record showed the physician failed to be contacted regarding the possibility of taking non-prescribed medications or the patient slurring words and some words non-comprehensive. During an interview on 05/24/2022 at 12:03 PM with administrator A, he/she stated that: - To establish the pain parameter in which to contact the physician the agency asks the patient their goal; and - If the patient’s goal is for example a 5, but the physician requests notification of an 8 or above, it would be expected for the physician to be contacted for clarification and have that documented in the medical record. During an interview on 05/24/2022 at 09:52 AM with administrator A, he/she stated that it would be expected for the physician to be contacted if a patient reported nausea, vomiting and diarrhea for two days and if a patient was suspected of taking medications not prescribed to them as well as having slurred speech and some words non-comprehensive.

The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 03/18/2021 during the survey it was determined Integrity Home Care and Hospice is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

A complaint investigation (#MO00182077) was completed on 03/18/2021 at Integrity Home Care and Hospice. The agency had 861 current patients. The complaint was substantiated. One or more of the allegations reported were verified and deficiencies were cited that are related to the allegations being investigated. The agency's noncompliance related to the comprehensive assessment of patients resulted in an immediate jeopardy (IJ) level finding, at: - §484.55 Comprehensive assessment of patients. An immediate jeopardy (IJ) level for actual harm to one patient (Patient # 1) and likelihood for current and future harm to patients was identified during the survey. The findings were confirmed as immediate jeopardy by the Centers for Medicare and Medicaid Services (CMS). On 03/10/2021 at 12:00 PM, the administrator was informed verbally and in writing via the IJ Template, of the findings(s) identified at an immediate jeopardy level. A formal written removal plan was submitted by the agency on 03/10/2021. This removal plan was reviewed by the state agency (SA) in conjunction with CMS and, it was not accepted as a satisfactory removal plan for the immediate jeopardy findings. A revised removal plan was submitted on 03/15/21. This removal plan was also reviewed by the SA and CMS and it was determined that a satisfactory removal plan had been initiated related to the IJ findings. The condition-level deficiency, §484.55 Comprehensive assessment of patients remains cited. An extended survey for Medicare certification was also completed for Integrity Home Care and Hospice on 03/18/2021. A COVID-19 Focused Infection Control survey was completed in conjunction with the extended survey and no deficiencies were identified related to the Focused Infection Control survey.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on policy review, record review, and interview, the home health agency failed to ensure that patients received a patient-specific comprehensive assessment that accurately reflected the patient's current health status which resulted in a complaint investigation with an immediate jeopardy level finding: - The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the patient's current health, psychosocial, functional, and cognitive status (G528). The cumulative effect of this deficient practice caused harm to one patient (Patient #1) and has the likelihood for harm for all the agency's patients. During the full survey conducted in conjunction with the complaint investigation, the following standard citation was found under this condition and requires correction: - Review of all medications the patient is currently using (G536).

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and interview, the agency failed to ensure the patient's current health status was assessed and documented in one (Patient/Record #1) of three records reviewed, and the agency failed to identify psychosocial needs of two (Patients/Records #4 and #8) of eight records reviewed. This deficient practice has the potential to affect the identification of patient needs for all patients on service with the agency. Findings included: Review of the agency policy titled, "Assessment of Patient Clinical Status," dated 10/01/2018 showed the following: - A full head to toe physical assessment will be performed; - On going assessments occur during routine visits; - Each wound is numbered and identified by anatomical location; - Functional assessment; - Safety of home environment; - Activities of daily living; and - Care management. RECORD/PATIENT #1: Review of the initial comprehensive assessment dated 02/10/2021 showed: - 75 year old admitted to home health agency post stay at Hospital #1 for a necrotic (dying) ulcer (sore) on his/her left heel; - Pressure ulcer of left heel, stage 3 (sore extends into the skin forming a small crater. Fat may show in the sore, but not muscle, tendon or bone); - Had a moderate protein-calorie malnutrition; - Had peripheral vascular disease (narrowing, blockage, or spasms in a blood vessel); - Had other cardiac conditions; and - The assessing clinician failed to assess/document a full head to toe physical assessment of the patient. The comprehensive assessment failed to include a full assessment of the patient's gluteal/buttock area, after the patient stated that, "he/she had a sore on my "butt", but hospital healed it". Clinical record review, from 02/10/2021 to 02/25/2021, showed five agency skilled nurses (SN) failed to complete/document a full head to toe assessment as part of the skin assessment during their nursing visits. The nurses failed to document a comprehensive assessment of the patient's buttocks. There was no skin assessment documented in the record for the patient's body, other than his/her left heel wound. The patient was noted on each visit to be sitting in his/her recliner, and the patient, on admission 02/10/21, had stated "sore on butt". The record failed to include follow up nursing documentation/assessment that the patient's gluteal/buttock area remained healed. Further review of the clinical record documentation showed the patient was always sitting in his/her recliner (a risk factor for skin break down in the elderly). Review of Hospital #1 episode summary report, dated 02/27/2021, showed the patient was transferred and admitted to the hospital on 02/25/2021 for sepsis (a life-threatening complication of an infection). The hospital record further documented wounds noted with largest on sacrum (buttocks) and an expanding, eroded (worn) left heel wound. The record also showed the patient's urine was purulent (pus), and a test on the patient's urine showed an infection. During an interview on 03/09/2021 at 12:30 PM, the hospitalist responsible for this patient during both hospital stays, validated that the patient was admitted to the hospital on 02/25/21 with sepsis and two (2) decubitus ulcers (wounds). The hospitalist stated the sacral wound was also present during the hospital stay that ended with a discharge on 02/09/2021 (prior to the home health agency admission). During an interview on 03/09/2021 at 2:45 PM, registered nurse (RN), RN A stated that during the comprehensive assessment he/she did not perform a complete head to toe assessment. RN A stated that the patient partially pulled down his/her pajama bottoms and that he/she was unable to do a complete assessment of the patient's bottom (buttocks). The above information was reviewed with the administrator on 03/10/2021 at 6:00 PM. The administrator concurred that there was not a head to toe assessment on this patient and that no further assessments of the patient's buttocks were found in the record. The administrator stated that nursing care should be complete. PATIENT/RECORD #4: Review of the initial comprehensive assessment dated 03/03/2021 showed: - 68 year old admitted to home health agency post stay at hospital for a surgical procedure, and post surgery developed a left groin wound; - Patient's medical history showed heart disease and peripheral vascular disease (PVD - narrowed or blocked blood vessels that supply blood to the legs); - Patient taking an anticoagulant (reduces blood thickening); and - Care management - stated no assistance needed - patient independent or does not have needs in this area. During a home visit observation on 03/15/2021 at 2:00 PM, medication review showed the patient was not taking clopidogrel (prevents blood clots) 75 milligrams (mg) as ordered on agency medication list, and patient stated "not taking, because I don't have a primary care doctor". During an interview on 03/16/2021 at 4:30 PM the administrator acknowledged the findings and no further information was provided. PATIENT/RECORD #8: Review of the initial comprehensive assessment dated 02/01/2021 showed: - 48 year old admitted to home health on 02/01/2021 for treatment of a wound on his/her left foot; - Legally blind; - Walks occasionally during the day, but for very short distances, with or without assistance. Spends majority of day in bed or chair; - Environmental Hazards -- indicated poor illumination; floor surfaces cluttered; - Care Management -- No assistance needed - Patient is independent or does not have needs in this area; and - Narrative note by nurse stated, "MSW (masters social worker) not needed at this time". During a home visit observation on 03/16/2021 at 12:30 PM, patient stated that he/she needed help with his/her house keeping. Patient's home environment was soiled and cluttered. Patient had a path only in his/her rooms. Due to patient's blindness he/she was unable to see to care for his/her home. During the visit the nurse stated that the patient's care giver was available by phone only. The above information was discussed with the administrator on 03/17/2021 at 11:00 AM, the administrator agreed with the findings.

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, record review, home visit observation, and interview, the agency failed to perform a review of all medications the patient is currently using in order to identify any potential adverse effects, drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy in three (Records/Patients #4, #6 and #8) of five records reviewed for medication administration. This deficient practice has the potential to affect the medication management of all patients served by the agency. Findings included: Review of the agency policy dated 01/13/21 and titled, "Medication Management," showed that: - Medication reconciliation will be completed at Start of Care (SOC), Resumption of Care (ROC) and any time a patient is seen in the emergency department (ED); - The admitting clinician initiates the patient's medication profile upon the SOC visit. This is completed by visualizing all medications within the patient's home and comparing it to the most recent medication list contained within the referral documentation. This includes prescription, over the counter, and herbal supplements the patient is taking. - Any discrepancies found during the medication reconciliation will be documented within the electronic medical record (EMR) and the physician will be notified. - Medication profile will reflect medication name, dosage, frequency, schedule, route, and instructions for administration including notation of which medications (if any) will be administrated by agency staff. - Any discrepancies which are identified during the reconciliation are brought to the attention of the attending physician immediately. This includes patient noncompliance. Documentation of this communication will be documented in the clinical record. - Medication reviews are completed during each subsequent visit. During the medication review process the clinician reviews medications on the medication profile within the EMR with the patient and/or patient caregiver and validates whether any changes have been made. Any new medications should be entered using a physician order. - Agency personnel do not store or transport medication, except for extenuating circumstances that are necessary for patient care. RECORD/PATIENT #4: Review of the clinical record showed that the patient was admitted to home health services on 03/03/21 for disruption of surgical wound and wound healing. During a home visit observation on 03/15/21 at 2:05 PM, review of the patient's medications compared to the agency medication list showed: - Doxycycline (antibiotic) ordered to take two times a day, order end date was 03/16/21, observation of the medication bottle showed 10 pills remaining, patient stated that he/she was only taking medication one time a day due to the medication upsetting his/her stomach; - Glipizide (blood sugar control) 10 milligrams (mg) noted on medication bottle, agency medication list showed 5 mg per day; - Clopidogrel (blood thinner) 75 mg one tablet daily per agency medication profile, medication was not found in the home; and - Over the counter probiotic was in the home and patient stated that he/she takes for his/her "stomach", medication was not listed on the agency medication list. The findings were presented to the administrator on 03/16/21 at 2:20 PM, no further documentation provided. RECORD/PATIENT #6: Review of the clinical record showed that the patient was admitted to home health services on 02/23/21 for an infection following a surgical procedure. During a home visit observation on 03/16/21 at 1:30 PM, review of the patient's medications compared to the agency medication list showed: - Agency medication list showed chlorzoxazone (muscle relaxant) 500 mg three times a day as needed (prn), patient stated that he/she had not been taking for "months"; - Agency medication list showed etodolac (relieve pain) 500 mg two times a day, patient stated that he/she had not been taking "for months", took in December; - Agency medication list showed triamcinolone acetonide (itching relief) topical cream two times a day prn, patient stated stopped using the cream eight months ago; - Agency medication list showed vancomycin (antibiotic) 50 mg/2.5 milliliter (ml) patient stated that he/she had not taken since 03/11/21 (medication was for 14 days only); Medication that patient stated that he/she was taking and not listed on the agency medication list are: - Hydrochlorothiazide (HCTZ-high blood pressure) 12.5 mg once daily, medication bottle showed an order date of 02/25/21; - Duloxetin (treat depression) 60 mg twice daily, medication bottle showed an order date of 02/07/21, - Ropinirole (treat restless leg) 1 mg at bedtime, medication bottle showed an order date of 02/11/21; and - Tolterodine ER (treat frequent urination) 20 mg daily, medication bottle showed an order date of 03/04/21. The findings were presented to the administrator on 03/17/21 at 3:20 PM, and no further documentation was provided. RECORD/PATIENT #8: Review of the clinical record showed that the patient was admitted to home health services on 02/01/21 for a wound on his/her left foot. During a home visit observation on 03/16/21 at 12:30 PM, review of the patient's medications compared to the agency medication list showed: - Lisinopril (treat high blood pressure) 5 mg daily, medication was not in the patient's home; and - Ventolin (for shortness of breath) HFA 90 micrograms (mcg)/actuation two puffs, medication was not found in the patient's home; and - Numerous capsules and medications found in the patient's medication box (too numerous to count), Licensed Practical Nurse (LPN) placed medications in a plastic bag and removed the medications from the home. The findings were presented to the administrator on 03/17/21 at 4:20 PM, the administrator stated that the LPN should not have removed the medications and no further documentation was provided.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of policy, and clinical record review, the agency failed to ensure the integration of orders from all physicians involved in the plan of care (POC) to assure the coordination of all services, interventions, and education was provided to the patients in two (Records/Patients #4 and #5) of three wound care records reviewed. This deficient practice has the potential to affect the coordination of care and services for all patients on service with the agency. Findings included: Review of the agency's policy titled, "Medication Management," dated January 13, 2021 showed: - Nurses provide instruction to the patient on a continuing basis: - The medication profile serves as a patient education guide; and - Care plan updates are made as indicated, to facilitate communication among clinicians. RECORD/PATIENT #4: Review of the plan of care (POC) showed that the patient was certified for home health from 03/03/2021 through 05/01/2021 with diagnoses of disruption of external operation (surgical) wound , infection following a procedure, wound left suprapubic/groin area. The POC showed: - The nurse to assess/evaluate wound left suprapubic/groin area; - The nurse to cleanse wound to left groin and provide wound care; and - The nurse to assess pain and effectiveness of pain management. During a home visit observation of wound care on 03/15/2021 at 2:00 PM, the patient had visible pain during wound care. On interview, the patient stated that no one had instructed the patient to take his/her pain medication prior to the nurse's arrival for wound care. Findings provided to administrator on 03/16/2021 at 12:30 PM, no further information provided at this time. RECORD/PATIENT # 5: Review of the POC showed that the patient was certified for home health care from 02/08/2021 through 04/08/2021 with the diagnosis of Cellulitis (an infection in the tissue under the skin, commonly associated with a small cut or abrasion) of the right and left lower limbs/legs. The POC showed: - The nurse to observe and assess integumentary (skin) status to identify changes; - The nurse to perform/teach wound care to venous stasis ulcer (wound) to rt/lt lower extremities - legs; and - The nurse to assess pain, effectiveness of pain management regimen and teach related to pain management. During the home visit observation on 03/16/2021 at 9:55 AM, the surveyor asked the patient if the nurse called/ instructed patient related to pain medication prior to wound care. Patient stated "not really" and patient stated that nurse did not call in advance of nursing visit. Findings provided to administrator on 03/16/2021 at 5:30 PM, no further information provided at this time.

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 nationally recognized standards, policy review, clinical record review, and home visit observation, the agency failed to assure the staff followed accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases in two (Records/Patients #4 and #5) of three home visits performed. This deficient practice has the potential to affect the standard precautions taken for all patients served by the agency. Findings included: Review of the Centers for Disease Control (CDC) publication dated 01/08/21 and titled, "Hand Hygiene in Healthcare Settings," showed the following clinical indications for hand hygiene: - Immediately before touching a patient; - Before performing an aseptic task (i.e., placing an indwelling device) or handling invasive medical devices; - Before moving from work on a soiled body site to a clean body site on the same patient; - After contact with blood, body fluids, or contaminated surfaces; and - Immediately after glove removal. Review of the agency policy dated 11/12/19 and titled, "Infection Control Plan," showed, the agency will comply with all applicable local, state, and federal regulations, including, but not limited to State and federal OSHA guidelines and CDC recommendations and guidelines. Review of the agency undated policy titled, "Application of Wound Dressing," showed: - Remove tape by pushing skin from tape. Remove soiled dressing. Discard dressing and gloves in appropriate containers. Decontaminate hands and don clean gloves. RECORD/PATIENT #4 and #5: During home visit observations on March 15 and 16, observation of the nurse showed the nurse placing multiple gloves on prior to wound care. Nurse removed soiled dressing and removed first layer of gloves. Nurse failed to remove all layers of gloves and perform hand hygiene. Home observation findings were reviewed with the administrator on 03/16/21 at 2:30 PM. The administrator stated that multiple layers of gloves was not in their policy. The administrator stated that the nurses should have removed their gloves and performed hand hygiene with each dressing change.