Indiana Masonic Home, Inc.

“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 observation, interview, and record review the agency failed to ensure all medications taken by the patient were recorded in the clinical record, in 1 of 3 home visit observations. Findings include: 1. Review of undated agency policy titled ‘MEDICATION MANAGEMENT C-705’ stated, “... Comprehensive client assessment performed at start of care and other defined points in time include a review of all medications the client is taking (prescribed, samples, over the counter, herbal remedies, PRN medications) and records this in the client record. Information that must be available in the record following the assessment includes: ... medications ...” 2. On 07-25-2024 at 9:30 AM during a home visit observation of Registered Nurse (RN)1 providing wound care for Patient #5, the patient indicated had used their sublingual Nitroglycerin (a medication in the form of a tablet, to be taken under the tongue and allowed to dissolve, which prevents and treats chest pain by relaxing your blood vessels) two nights ago after experiencing intense pain, and subsequently experienced complete relief after taking a second dose, praying, and laying down. RN 1 asked nothing further of the patient regarding the Nitroglycerin. 3. Review of the clinical record for Patient #5 with a start of care date 05-03-2024, contained diagnoses, which included but were not limited to: Atherosclerotic heart disease of native coronary artery without angina pectoris (a condition of the heart where there is a buildup of fats, cholesterol, and other substances in and on the artery walls, usually causes coronary artery disease, the buildup, called plaque, makes the arteries of the heart become narrowed, symptoms from the lack of blood flow to the heart may include chest pain (called angina) and shortness of breath. A complete blockage of blood flow can cause a heart attack) and old myocardial infarction (previous heart attack). Further review of the record failed to evidence Nitroglycerin had been included in the Medication profile. 4. On 07-25-2024 at 2:30 PM, RN 1 was queried as to the client’s record failing to evidence the medication, indicated they were not aware Patient #5 had this medication and would be calling the patient’s primary care physician to obtain more information.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on record review and interview the agency failed to ensure a patient received services as frequently as ordered in the Plan of Care, (see G0572), the agency failed to ensure their clinicians obtained a physician order prior to performing wound care (see G0580), the agency failed to notify the ordering provider when a lapse in ordered, regularly scheduled wound care occurred, and the agency failed to notify physicians when the agency became aware of possible contamination of wounds had occurred, (see G0590), and the agency failed to ensure patients received a Plan of Care, Medication list, and visit schedule (see G0612). The cumulative effect of these deficient practices resulted in the agency’s inability to ensure patients received ordered services for all 6 active patients with NPWT (Negative Pressure Wound Therapy, also known as ‘wound vac’), with the potential to impact a total of 23 current patients receiving wound care services from the agency. *”

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on record review and interview the agency failed to ensure field staff followed appropriate infection control practices per agency policy while providing wound care to patients, and the agency failed to take action when the agency became aware patients’ wounds had been potentially contaminated (see G0682). The cumulative effect of these deficient practices resulted in the agency’s inability to ensure patients received appropriate services which has the potential to affect all 6 current patients with NPWT (Negative Pressure Wound Therapy, also known as ‘wound vac’), with the potential to impact a total of 23 current patients receiving wound care services from the agency. *”

“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 record review and interview the agency failed to ensure a patient received services as ordered in the Plan of Care for 1 of 6 patients with a wound vac (device used to aide in the healing of a progressive wound). (Patient #1) Findings include: 1. Review of an undated agency document titled ‘PLAN OF CARE C-580’ stated, “... 2. The plan of Care shall be completed in full to include: ... c. Type, frequency, and duration of all visits/services ... l. ... treatments, and procedures ... 10. Professional staff shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ...” 2. Review of an undated agency document titled ‘SKILLED PROFESSIONAL SERVICES C-200’ stated, “... 1. Skilled professionals must assume the responsibility for, but not be restricted to the following: ... c. Providing services that are ordered by the physician as indicated in the plan of care ... g. Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care ...” 3. Review of the clinical record for Patient #1 evidenced a start of care date of 11-30-2023 for the certification period of 01-23-2024 to 03-28-2024, contained diagnoses which included but were not limited to: Multiple Sclerosis (a potentially disabling disease of the brain and spinal cord (central nervous system) where the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body), Paraplegia, complete (a total loss of function, including the ability to feel sensation and move, the body also can’t control automatic functions that rely on your spinal cord for relaying signals, such as controlling your bladder and bowels), suprapubic catheter (tube which drains urine from the bladder, inserted into the bladder through a small hole in the lower abdomen), and cognitive impairment (when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life). The record indicated the patient was dependent on others for transferring and mobility (the ability to change and control body position). The record evidenced a total of six (6) wounds were being treated. Two (2) of the wounds, the coccyx (tailbone) and left ischium (one of the three bones that make up the pelvis) required the use of specialized equipment. The record contained orders for NPWT (Negative Pressure Wound Therapy also known as ‘wound vac’: a broad term describing a unique system that aids wound healing through the application of vacuum pressure to reduce inflammatory drainage and promote the growth of healthy tissue) dressing changes 3 times each week to the coccyx and left ischium wounds. Home Health Skilled Nursing was ordered twice weekly for wound care and wound vac dressing changes, on Mondays and Fridays, and PRN (as needed). Patient #1 would visit Entity G, the ordering provider’s wound clinic, for wound vac changes and other wound care every Wednesday. The record evidenced a Missed Skilled Nursing visit for wound care on Friday, 02-16-2024, and again on Monday, 02-19-2024. Communication notes from the record failed to evidence the agency contacted Entity G on Friday, 02-16-2024 regarding the missed Skilled Nursing visit for wound care. 4. Review of a document dated 02-21-2024, from Entity D, a Local Law Enforcement agency, titled ‘Investigation Narrative’ indicated on 02-21-2024 Entity G, the ordering provider office and wound clinic, had initiated a request for law enforcement to perform a welfare check on Patient #1 and the spouse related to concerns for health and safety. The report indicated after opening an unlocked back door, officers found Patient #1’s spouse had expired, and then found the patient, “… it was evident that [Patient #1] had been laying in bed for quite some time, as [Patient #1] had been laying in what appeared to be [their] own urine and feces, which appeared to saturate [their] side of the bed …”. The report further indicated an ambulance was dispatched to the home and the patient was transported to the hospital. 5. Review of a document dated 02-21-2024, from Entity F, an Acute Care Hospital, titled ‘Emergency Documentation’ indicated, “… [Patient #1] transported from home after unfortunately being found in bed, unaware that [spouse] had died, likely at least several days ago. Patient is entirely reliant on [spouse] to care for [patient] at home. I am concerned about prolonged time down in bed. Differential diagnosis includes acute kidney injury, rhabdomyolysis, dehydration, electrolyte derangement, urinary tract infection related to contaminated suprapubic catheter, many others.” ‘Discharge Summary’ indicated, “… [Patient #1] was admitted for UTI and infection of chronic wounds … Patient presented to [Entity F] following PCP [Entity G] calling a well check as the patient had been a no show for appointment today. Home Healthcare provider was also unable to gain access to patient’s home at which time [Entity D] was called. [Entity D] broke into the home and found patient soiled and unkempt for unknown time frame. Patient’s [spouse] was then discovered dead … for an estimated seven days time. [Spouse] was patient’s primary care provider performing all patient’s ADLs and was responsible for all positioning in mobility. Patient is unable to report the last time [they] saw [spouse] … Admitted per above. Patient previously following with [Entity G] for chronic osteo to the sacrum, gluteal pressure ulcer and left heel ulcer. Wounds found to be infected and did grow streptococcus agalactiae and enterococcus faecalis. [Patient #1] did receive 5 days of IV Rocephin and plan to continue Azithromycin for 5 additional days at time of discharge. Urine culture also growing Proteus mirabilis treated with 5 days of Ceftriaxone. Also initiated on Citalopram for history of anxiety, depression in the setting of dementia, MS and recent death of [spouse]. Discharge to [Entity L, a skilled nursing facility] for skilled nursing care for complex wound management …” 6. On 06-12-2-024 at 11:59 AM Nurse Practitioner (NP) H with Entity G, a wound clinic, indicated had cared for Patient #1 for years and indicated Patient #1 was last seen in their office on Wednesday, 02-14-2024 accompanied by the patient’s spouse who was also the primary caregiver. Indicated their office did not receive a call from the home health agency on Friday, 02-16-2024 when RN 1 did not see the patient for wound care, but first learned of missed visits when they received a call on Monday, 02-19-2024 from the home health agency who then reported the patient could not be contacted for a second time. 7. On 06-12-2024 at 6:02 PM, in a telephone interview, when queried as to what actions would be taken if a wound patient were unable to be contacted, Registered Nurse (RN) 1 indicated would contact the agency office, contact the doctor, and would keep the patient on their schedule and adjust their day to accommodate the patient as needed. Indicated further they often worked holidays ‘because wound vacs can’t be moved’. When queried as to what would occur if a wound vac patient could not be reached after multiple attempts, RN 1 indicated ‘never had that happen’ but if it did, they would call the office or for a ‘well visit’ especially if it was an outlier or out of the normal for the patient. When asked to define a ‘well visit’, indicated this meant calling the police. Indicated had called for ‘well visits’ in the past for other patients, and would ‘stay until they (police) get there, to find out what happens’ (to the patient). When queried as to the events surrounding Patient #1, indicated it was not uncommon for Patient #1’s spouse to cancel nursing visits and perform the wound care themselves, often telling staff ‘I got it, don’t worry about it’. When queried as to what happened when Patient #1 could not be reached for their wound care visit on 02-16-2024, RN 1 indicated could not recall dates, but recalled the last time he/she went back to the home, no one answered so they told the Director of Nursing to call ‘well check’ and indicated ‘that’s when they found what they found’. 8. On 06-13-2024 at 9:13 AM, in a follow-up telephone interview, when queried as to how often a wound vac dressing ought to be changed, RN 1 indicated ‘for Monday, Wednesday, and Friday usually’ and indicated the consequences of overdue wound vac changes were infection or sepsis. Indicated that the Friday, 02-16-2024 visit for Patient #1 was missed as the patient could not be reached by phone or by knocking on the door. When queried as to why a ‘well check’ was not requested, indicated would not call for a well check on every missed visit, and reiterated that it was not abnormal for the spouse to remove the wound vac and apply a wet-to-dry dressing instead. Indicated there was no need for a well check because the spouse knew how to care for the wound. 9. On 06-13-2024 at 9:23 AM, when queried as to Patient #1’s missed visits for care and what had transpired afterward, the Clinical Director indicated that she and RN 1 had spoken at length, but there was no documentation of that conversation nor of what was discussed. Indicated RN 1 did not call the doctor because they were not prompted to call the doctor by the agency’s Electronic Medical Record (EMR) system, but then indicated RN 1 ‘still’ should have called the doctor the same day. 10. On 6-13-2024 at 1:08 PM, in an in-person interview, RN 1 was asked to clarify what was meant by ‘I would have never gone in the back’ as stated in the previous interview. RN 1 indicated ‘I am not creeping around houses’ ‘for my safety’. Then indicated on Friday, 02-16-2024, had gone to Patient’s #1 home and called from the home while on-site, and could hear the phone ringing inside, believed the patient answered the phone and thought the patient and spouse could both be heard speaking to each other but the sound was muffled, and they did not answer/address the nurse. RN 1 attempted to call back a few times, but ‘kept getting busy signals’ and suspected the patient and spouse had not properly hung up/disconnected their cordless phone handset. RN 1 indicated had returned to the home the following Monday, 02-19-2024, but this time could hear the phone just continuing to ring from the outside. When queried as to a back-up plan when the patient could not be reached the first time, the Clinical Director indicated there was not a plan, and a follow-up nursing visit was not attempted over that weekend, nor had a follow-up nursing visit been considered. When queried as to whether there was concern in light of the fact the caregiver, who was normally communicative (by the agency’s account and by the account of Entity G), could not be readily reached, should have alerted the agency and prompted further action or follow-up on the agency’s part, RN 1 and the Clinical Director indicated affirmatively this should have alerted the agency. RN 1 then indicated, ‘I wouldn’t have changed anything’ they had done.”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients received a Plan of Care, a Medication list, and a schedule in 2 of 3 home visits conducted. (Patients #4 and #6) Findings include: 4. On 06/17/2024 at 9:30 AM, during a home visit for Patient #6, the home folder failed to evidence a Plan of Care, a completed visit schedule, or a medication list. 5. On 06/17/2024 at 10:30 AM, when queried as to whether they were aware or played a role in patient’s receiving their Plans of Care/485, visit schedule/calendar, or a medication list, or if they were ever instructed by the office to bring such documents out to the patients home, RN 1 indicated was not a part of this and was not aware of this practice. 6. On 06/17/2024 at 11:31 AM, Registered Nurse (RN) 1 indicated had been wrong about their earlier recollection regarding Plans of Care, visit schedules/calendars and medication lists being provided for patients, and indicated they had in fact been educated upon hire regarding the patients needing to receive the aforementioned items, but had subsequently forgotten. 7. On 06/17/2024 at 12:19 PM, during a telephone interview, Patient #6 indicated they had not ever been provided with a Plan of Care or ‘485’ document, a calendar or visit schedule, nor had they been provided with a list of their medications from the agency. Reiterated they had their own list of medications, but this was not from the agency. 1. On 06/17/2024 at 11:48 AM, the Clinical Director indicated there was no agency policy to provide their Patients with a copy of their Plan of Care, a medication list, and a schedule. 2. On 06/14/2024 at 12:30 PM, during a home visit at Patient #4”s home, when queried regarding their agency folder, Person I, a family member to Patient #4 indicated they had been given one but they didn’t remember where they put it. When queried if they had been given or received a mailing of a schedule of visits, a medication list, and a plan of care, both Patient #4 and Person I indicated they had never received anything in the mail or from a nurse regarding a schedule, a medication list, or a plan of care. 3. On 06/17/2024 at 9:44 AM, the Administrator indicated all Patient’s should have an updated Plan of Care, a medication list, and a schedule in their home folders, and they should be updated every 60 days.”

“Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure their Quality Assessment Performance Improvement program included tracking adverse events, analyzing their cause, and implementing preventive actions. Findings include: 1. Review of an undated agency document titled ‘Quality Assessment and Performance Improvement (QAPI) B-260’ stated, “POLICY ... HHSCP will maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS ... PURPOSE To monitor the effectiveness and safety of services and the quality of care ... To identify opportunities for improvement ... To use performance improvement activities to track adverse client events, analyze their causes and implement preventive actions ... To measure agency success and ensure improvements are sustained ... SCOPE OF PROGRAM ... 2. The agency will identify, measure, analyze, and track quality indicators that include client adverse events, and other relevant data to assess processes of care, services, and operations ... STANDARD PROGRAM ACTIVITIES ... 3. The programs activities will lead to an immediate correction of identified problems that directly or potentially threaten health and safety of clients. 4. Adverse events will be tracked and analyzed for cause and document the implementation of preventative actions. 2. Review of an undated agency document titled ‘SAFETY MANAGEMENT PROGRAM B-315’ stated, “... 10. Documentation of incidents, including follow-up documentation with trends and patterns will be incorporated into the the agency performance improvement plan ...” 3. Review of agency records evidenced a Fall Log, Complaint/Incident Log, and rehospitalization log containing entries of events. The rehospitalization log contained an entry regarding Patient #1, dated 02-19-2024, which stated, “... Reason for Admission ... Husband (sole caregiver) passed at home ...” and failed to detail information on the patient, circumstances leading to hospitalization, or their admitting diagnosis. 4. Review of the agency’s QAPI Binder failed to evidence the agency had Performance Improvement Plans (PIPs) in place, indicated action was taken on areas of concern but failed to evidence details of the actions/strategies referred to, and failed to evidence measurable progress toward established goals. The program failed to evidence the incident regarding Patient #1 had been addressed. 5. Review of the clinical record for Patient #1 indicated the patient was dependent on others for transferring and mobility (the ability to change and control body position). The record evidenced a total of six (6) wounds were being treated by the home health agency. Two (2) of the wounds, the coccyx (tailbone) and left ischium (one of the three bones that make up the pelvis) required the use of specialized equipment. The record contained orders for NPWT (Negative Pressure Wound Therapy also known as ‘wound vac’: a broad term describing a unique system that aids wound healing through the application of vacuum pressure to reduce inflammatory drainage and promote the growth of healthy tissue) dressing changes 3 times each week to the coccyx and left ischium wounds. Home Health Skilled Nursing was ordered twice weekly for the wound care and wound vac dressing changes, on Mondays and Fridays, and PRN (as needed). Patient #1 visited Entity G, the ordering Provider’s wound clinic, for wound vac changes and other wound care every Wednesday. The record evidenced a Missed Skilled Nursing visit note for wound care on Friday, 02-16-2024, and again on Monday, 02-19-2024. Communication notes from the record failed to evidence the agency contacted Entity G on Friday, 02-16-2024 regarding the first missed Skilled Nursing visit for wound care. The record evidenced a well check was requested for Patient #1 on Wednesday, 02-21-2024 when Entity G, reported the patient was a no-show for their weekly visit. 6. Review of a third-party document from Entity F, a local acute care hospital, indicated the patient was found by Entity D, local law enforcement, during the welfare check and had been left in their bed, unattended for 3-7 days. The patient’s spouse (who was the primary caregiver) was found deceased in the home. The patient was transported to Entity F and admitted with a urinary tract infection and infection of the wounds. 7. On 06-13-2024 at 9:23 AM, when queried as to whether the incident regarding Patient #1’s two (2) missed skilled nursing visits and subsequent hospitalization would be found in QAPI, the Clinical Director indicated this incident was not in QAPI, as it was not a ‘complaint’, but was instead likely under ‘rehospitalizations’.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interview the agency failed to ensure their Quality Assessment Performance Improvement (QAPI) program evidenced at least one Performance Improvement Project (PIP) being conducted. Finding include: 1. Review of an undated agency document titled ‘Quality Assessment and Performance Improvement (QAPI) B-260’ stated,”... PERFORMANCE IMPROVEMENT PROJECTS 1. Beginning July 13, 2018, agencies must conduct performance improvement projects a. The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the agency services and operations b. The agency must document the quality performance improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects ...” 2. On 06-13-2024, a review of agency records evidenced a Fall Log, Rehospitalization Log, and Complaint/Incident Log. The QAPI Binder failed to evidence Performance Improvement Plans (PIPs) were in place, made reference to actions taken/strategies utilized, but failed to evidence details, information or documentation on follow-up or measurable progress toward established goals. 3. On 06-13-2024 at 4:08 PM, the Clinical Director/Alternate Administrator indicated would get in touch with the Administrator to inquire if there was documentation anywhere else regarding any agency PIP(s). On 06-14-2024 at 10:05 AM, the Clinical Director indicated had conferred with the Administrator who indicated regarding any QAPI documentation or Performance Improvement Plans, everything would be in the binder and there was not anything more.”

“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 observation, record review, and interview, the agency failed to ensure field staff followed appropriate infection control practices per agency policy while providing patient care in 3 of 3 home visits conducted, and the agency failed to take action when made aware wounds were potentially contaminated (Registered Nurse (RN) 1, Licensed Practical Nurse (LPN) 1 and 2, and Clinical Director) Findings include: 5. On 06/14/2024 at 1:00 PM during a home visit with Licensed Practical Nurse (LPN) 1 for Patient #8’s wound care, the LPN was observed performing a wound vac dressing change to the patient’s right heel. Patient #8 was positioned in their recliner with their legs propped up on the chair’s footrest and LPN 1 placed their scissors, a small pair of pink bandage scissors, a larger pair of pink bandage scissors, and a few packets of Skin-Prep Protective Wipes (pre-packaged moistened wipes that when applied to the skin forms a barrier between the skin and adhesives to help preserve skin integrity and prevent insult or injury during removal of tapes and films) directly on the surface of the footrest, between the patient’s legs, without a barrier. Later in the visit the nurse, with gloved hands, picked up the larger pair of pink scissors and used them to cut a piece of black foam wound dressing that was then placed directly against the wound bed. Later in the visit LPN 1 took the patient’s vital signs, utilizing the following vital sign equipment: a stethoscope, pulse oximeter (an electronic device that measures the saturation of oxygen carried in your red blood cells and checks your pulse rate), thermometer, and blood pressure cuff, which had all been sitting on the bare surface of a coffee table nearby. The table was visibly dusty and there was not a barrier in place. After vital signs were taken, all items were then sanitized with a disposable sanitizing wipe and put directly back into the nursing bag. At the end of the visit, the nurse pulled a disposable barrier out from underneath their nursing bag which had been placed on the floor, the nursing bag then sat in direct contact with the surface of the bare floor. LPN 1 was queried as to whether they had sanitized the surface of the footrest before placing items there, LPN 1 indicated they had not sanitized the surface and indicated understanding they had likely contaminated the wound using scissors that had contact with a potentially contaminated surface, and then had cut into the black foam wound dressing which was then placed directly on the surface of the wound, thereby potentially contaminating the wound. LPN 1 indicated should have used a barrier from the start for the vital sign equipment and indicated realized their mistake when pulling the disposable barrier out from underneath the nursing bag, and should have done that differently. 6. On 6-17-2024 at 9:30 AM during a home visit with Registered Nurse (RN) 1 for Patient #6’s wound care, the RN was observed performing a wound vac dressing change to the lower abdomen. The patient was reclined in bed and the old dressing was removed. The nurse doffed their gloves, performed hand hygiene and donned new gloves, cleansed the wound with wound cleanser and 4x4 gauze. The nurse was noted to be wearing a dark, thin, string-like bracelet on the right hand, the loose end of the bracelet hanging down approximately 1.0 - 1.5 inches off the wrist, this not covered by the glove worn. The loose end of the bracelet made contact with the bare wound bed, and gloves were doffed. When it was noted the bracelet had made contact with the wound bed, the nurse promptly removed the bracelet. When queried, the nurse indicated understanding they had inadvertently but likely contaminated the wound. Returning to the wound the nurse performed hand hygiene, donned new gloves, cleansed the wound again, and completed the wound vac dressing change. 7. On 06-14-2024 at 4:57 PM, the Clinical Director and the Alternate Clinical Director were informed of infection prevention breaches that occurred during the home observations for Patient #4 and Patient #8 on 06-14-2024, related to poor aseptic technique during wound vac dressing changes. The Clinical Director indicated understanding that there were now two potentially contaminated wounds in the field and indicated to the Alternate Clinical Director they ‘needed to get those changed’. On 06-17-2024 at 11:30 AM, the Administrator, Clinical Director, and Alternate Clinical Director were queried as to actions taken and outcome for Patients #4 and #8 after being notified of breaches in infection prevention during the wound care provided three days prior. The Clinical Director indicated that the patient’s physicians had not been notified, the patients had not been seen, and could not answer if either patient was currently receiving antibiotic therapy. The Clinical Director indicated the patients’ physicians should have been contacted on Friday, but indicated both patients were scheduled for nursing visits today. 1. A review of an undated policy titled, ‘INFECTION PREVENTION/CONTROL B-403’ revealed, “... STANDARD PRECAUTIONS - TIER ON ... 2. Hands are washed ... immediately after gloves are removed, between client contacts, and when indicated to prevent transfer of microorganisms ...”. 2. A review of an undated policy titled, ‘HANDWASHING/HAND HYGIENE D-330’ revealed, “... SPECIAL INSTRUCTIONS ... 3. Indications for hand washing and hand antisepsis: ... d. Between tasks on the same client. e. Before touching a wound. f. After removing gloves. g. After touching objects that are potentially contaminated. ...”. 3. On 06/14/2024 at 1:18 PM during a home observation with LPN 2 for Patient #4’s wound care, LPN 2 created a barrier for their nursing bag, performed hand hygiene, reached into the nursing bag for supplies, put normal saline syringes on the barrier and put gauze pads and scissors on top of their laptop, which was not observed to be clean. LPN 2 placed alcohol pads on the table. LPN 2 cleaned the pulse oximeter (an electronic device that measures the saturation of oxygen carried in your red blood cells and checks your pulse rate) with an alcohol pad, placed it on Patient #4’s finger, used a gloved hand reached into their nursing bag to retrieve their thermometer, took Patient #4 temperature, and placed the thermometer on top of alcohol pads that were on the table. LPN 2 moved the barrier that contained the normal saline syringes along with the gauze and scissors to the floor by the recliner, placed a box of gloves on the floor next to the barrier, and placed a barrier under Patient #4 right heel. Without a change of gloves and hand hygiene performed, LPN #2 used normal saline syringes to clean the wound on the right heal, dried it with the gauze, and applied the Quticell (used on superficial exuding wounds such as first- and second-degree burns, cuts and abrasions, lacerations, radiation injuries, and donor and recipient skin graft sites), and covered with roll gauze, and then ace wrapped the right heel. While wound care was performed, 2 normal saline syringes had fallen off the barrier onto the floor. At 1:46 PM, LPN 2 removed their gloves did not perform hand hygiene, picked up the 2 normal saline syringes, the package of gauze, and the box of gloves off the floor and placed them into their nursing bag, gathered the barriers off the floor, threw them in the trash, went to the kitchen sink, and washed their hands appropriately, and turned the water off with their bare hands. Patient #4 proceeded to their bedroom for the wound treatment to their left buttock and indicated they would say when they were ready. At 1:53 PM, LPN 2 asked if Patient #4 was ready, and they indicated they were. LPN 2 created a barrier on Patient #4’s bed, hand hygiene performed, and reached into their bag for scissors, alcohol pads, and a marker. LPN 2 reached into a box by Patient #4’s bed to retrieve the Negative pressure wound therapy kit (NPWT) (Negative Pressure Wound Therapy also known as ‘wound vac’: a broad term describing a unique system that aids the optimization of wound healing through the application of vacuum pressure to reduce inflammatory drainage and promote the growth of healthy tissue), and without hand hygiene, reached into their nursing bag for the box of gloves and placed them on the foot of Patient #4’s bed, performed hand hygiene, donned gloves, placed a barrier under Patient #4’s buttock, then touched the clean barrier, and reached into their nursing bag for more barriers. LPN 2 cleaned their scissors with an alcohol pad, turned the NPWT pump off, doffed their gloves, without hand hygiene donned a pair of gloves, and opened gauze dressings and syringes. At 2:03 PM LPN 2 unhooked the tubing from the dressing, with the end that was attached to the machine lying on Patient #4’s bed, LPN 2 removed the dressing. Once removed, LPN 2 doffed their gloves, without hand hygiene, reached into their nursing bag, retrieved packaged Q-tips, then performed hand hygiene, and donned gloves. Using a Q-tip and a measuring device to obtain measurements of the wound, doffed their gloves, without hand hygiene, picked up the marker, and marked on the measuring tape the measurements of the wound. LPN #2 without hand hygiene, donned gloves, used normal saline syringes began to cleanse the wound, used gauze to dry the wound, doffed their gloves, and performed hand hygiene. LPN 2 donned gloves, using skin prep around the wound, then doffed their gloves without hand hygiene. While performing that task, a packaged normal saline syringe and 3 skin prep packages slid off the barrier onto the bed. Without hand hygiene, LPN 2 donned a pair of gloves, opened the NPWT kit, cut strips to prepare for placement around the wound, then placed them around the peri-wound.. LPN 2 began cutting a long strip (approximately 12 inches) of the black sponge that was to be placed in the wound bed. As LPN 2 had attempted to place the sponge into the wound bed with their gloved finger, some of the sponge came out, and they pushed it back into the wound, and continued to pack the wound with their finger until it appeared to be full, then proceeded to dress the wound, reapplied the NPWT to the dressing, and turned the pump on. 4. On 06/14/2024 at 2:45 when queried if it was normal to use their finger to try to pack the wound with the sponge, LPN 2 indicated they felt they couldn’t stop the dressing change at that point to retrieve a Q-tip from their nursing bag. When queried about hand hygiene, LPN 2 indicated they thought they performed hand hygiene when they should have. When queried if they were to put unused items that had fallen off the barriers or items that had been placed on the floor or the patient’s bed back into their nursing bag, they indicated it was fine. When queried LPN 2 if the inside of the nursing bag was clean, they indicated it was, this writer queried after placing the normal saline syringes, gauze pads, and the box of gloves that had been on the floor and the patient’s bed, was their nursing bag still clean, LPN 2 indicated it probably was not. On 06/14/2024 at 3:59 PM the Clinical Director indicated they expect clinicians to perform hand hygiene every time gloves are removed, a sterile Q-tip should be used to push the black sponge into the wound, and anytime disposable items fall off the barrier the items should be discarded, not placed back into the nursing bag.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure their clinicians obtained a physician order prior to performing wound care in 1 of 6 active record reviews. (Patient #3) Findings include: 1. A review of an undated policy titled ‘PLAN OF CARE C-580’ revealed, “... 10. Professional staff shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ...”. 2. A review of an undated policy titled ‘PHYSICIAN ORDERS C-635’ revealed, “... All medications and treatments, ... must be ordered by the physician ...”. 3. A review of the clinical record for Patient #3 revealed a document titled “Home Health Care Certification and Plan of Care for the certification periods of 04/11/2024 through 06/09/2024 signed by the Director of Nursing on 04/16/2024. Patient #3 diagnoses included but were not limited to Pressure ulcer of other site Stage 2 (partial thickness loss of dermis [middle layer of skin] presenting as a shallow open area with a red or pink wound bed, without slough or bruising] and Abrasion of lower back and pelvis. For the certification period of 04/16/2024 through 06/09/2024 Patient #3 was to receive skilled nursing visits 1 time a week to assess pain, assess pressure ulcer status. Further review of the clinical record evidenced a skilled nursing visit conducted on 06/04/2024, from 12:28 PM to 1:03 PM signed by LPN 2, the narrative note evidenced, “SN performed wound care per MD order without complication ... Pt indicates discomfort at right pannus. Upon SN visual assessment pt has stage 2 skin breakdown of area approximation 10 x 8.5x 0.1 ... SN to call MD and request order for tx. SN cleansed area with saline, pat dry, applied saline moistened Puracol sheet and bordered gauze dressing to area ... “. A review of the clinical record of Patient #3 evidenced a document titled “PATIENT CARE ORDER” dated 06/05/2024 signed by LPN 2 evidenced, “Cleanse wound with normal saline, pat dry, apply Puracol to the wound bed, cover with border foam gauze. Effective 06/05/2024, Twice weekly, - read back and confirmed; start date 06/05/2024”. The agency failed to ensure staff obtained physician orders before the treatment of a wound on 06/04/2024. 4. On 06/14/2024 at 2:45 PM, LPN 2 stated, “If a Patient has a new wound, I can look at it but I can’t treat it and must notify the physician”. When queried if they would notify anyone else, LPN 2 indicated they would notify the office. On 06/14/2024 at 8:25 AM, the Director of Nursing indicated when a new wound is identified during a visit, the clinician should not treat it, maybe cover it, report it to the physician preferably while onsite with the Patient, and obtain physician orders.”

“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 record review and interview the agency failed to notify the ordering provider when a lapse in ordered, regularly scheduled wound care occurred and the agency failed to notify physicians when the agency became aware of possible contamination of wounds had occurred, in 1 of 10 clinical records reviewed (Patient #1) and 2 of 3 home visits observed (Patients #4 and #8) Findings include: 1. Review of an undated agency document titled ‘PLAN OF CARE C-580’ stated, “... 10. Professional staff shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ...” 2. Review of an undated agency document titled ‘CLINICAL DOCUMENTATION C-680’ stated, “... 6. Services not provided and the reason for the missed visit will be documented and reported to the physician ...” 3. Review of the clinical record for Patient #1 indicated the patient was dependent on others for transferring and mobility (the ability to change and control body position). The record evidenced a total of six (6) wounds were being treated by the home health agency. Two (2) of the wounds, the coccyx (tailbone) and left ischium (one of the three bones that make up the pelvis) required the use of specialized equipment. The record contained orders for NPWT (Negative Pressure Wound Therapy also known as ‘wound vac’: a broad term describing a unique system that aids wound healing through the application of vacuum pressure to reduce inflammatory drainage and promote the growth of healthy tissue) dressing changes 3 times each week to the coccyx and left ischium wounds. Home Health Skilled Nursing was ordered twice weekly for the wound care and wound vac dressing changes, on Mondays and Fridays, and PRN (as needed). Patient #1 would then visit Entity G, the ordering Provider’s wound clinic, for wound vac changes and other wound care every Wednesday. The record evidenced a Missed Skilled Nursing visit note for wound care on Friday, 02-16-2024, and again on Monday, 02-19-2024. Communication notes from the record failed to evidence the agency contacted Entity G on Friday, 02-16-2024 regarding the first missed Skilled Nursing visit for wound care. 4. On 06-12-2-024 at 11:59 AM, Nurse Practitioner (NP) H with Entity G, a wound clinic, indicated had cared for Patient #1 for years and indicated Patient #1 was last seen in their office on Wednesday, 02-14-2024 accompanied by the patient’s spouse who was also the primary caregiver. Indicated their office did not receive a call from the home health agency on Friday, 02-16-2024 when RN 1 did not see the patient for wound care, but first learned of missed visits when they received a call on Monday, 02-19-2024 from the home health agency who then reported the patient could not be contacted for a second time. Indicated it was abnormal for the spouse not to call, as he/she was very communicative with the wound care clinic. Indicated the wound clinic themselves attempted to reach Patient #1 on Tuesday, 02-20-2024 and followed up with other providers as well, without success. On Wednesday, 02-21-2024 when Patient #1 did not show up for their weekly appointment, Entity G indicated other providers were again contacted to determine the patient’s whereabouts, and it was at that time the police were dispatched to perform a welfare check at the patient’s home. NP H indicated was worried about the patient, the wound vac still being in place, and expressed concern for possible infection or sepsis. Indicated had learned of the spouse’s demise and that the patient had been transported to a local hospital for care and had since been transferred to a Skilled Nursing Facility. On 06-12-2024 at 6:02 PM, in a telephone interview, when queried as to what actions would be taken if a wound patient were unable to be contacted, Registered Nurse (RN) 1 indicated would contact the agency office, contact the doctor, and would keep the patient on their schedule and adjust their day to accommodate the patient as needed. Indicated further they often worked holidays ‘because wound vacs can’t be moved’. When queried as to what would occur if a wound vac patient could not be reached after multiple attempts, RN 1 indicated ‘never had that happen’ but if it did, they would call the office or for a ‘well visit’ especially if it was an outlier or out of the normal for the patient. When asked to define a ‘well visit’, indicated this meant calling the police. Indicated had called for ‘well visits’ in the past for other patients, and would ‘stay until they (police) get there, to find out what happens’ (to the patient). When queried as to the events surrounding Patient #1, indicated it was not uncommon for Patient #1’s spouse to cancel nursing visits and perform the wound care themselves, often telling staff ‘I got it, don’t worry about it’. When queried as to what happened when Patient #1 could not be reached for their wound care visit on 02-16-2024, RN 1 indicated could not recall dates, but recalled the last time he/she went back to the home, no one answered so they told the Director of Nursing to call ‘well check’ and indicated ‘that’s when they found what they found’. On 06-13-2024 at 9:13 AM, in a follow-up telephone interview, when queried as to how often a wound vac dressing ought to be changed, RN 1 indicated ‘for Monday, Wednesday, and Friday usually’ and indicated the consequences of overdue wound vac changes were infection or sepsis. Indicated that the Friday, 02-16-2024 visit for Patient #1 was missed as the patient could not be reached by phone or by knocking on the door. When queried as to why a ‘well check’ was not requested, indicated would not call for a well check on every missed visit, and reiterated that it was not abnormal for the spouse to remove the wound vac and apply a wet-to-dry dressing instead. Indicated there was no need for a well check because the spouse knew how to care for the wound. On 06-13-2024 at 9:23 AM, when queried as to Patient #1’s missed visits for care and what had transpired afterward, the Clinical Director indicated that she and RN 1 had spoken at length, but there was no documentation of that conversation nor of what was discussed. Indicated RN 1 did not call the doctor because they were not prompted to call the doctor by the agency’s Electronic Medical Record (EMR) system, but then indicated RN 1 ‘still’ should have called the doctor the same day. On 6-13-2024 at 1:08 PM, in an in-person interview, RN 1 was asked to clarify what was meant by ‘I would have never gone in the back’ as stated in the previous interview. RN 1 indicated ‘I am not creeping around houses’ ‘for my safety’. Then indicated on Friday, 02-16-2024, had gone to Patient’s #1 home and called from the home while on-site, and could hear the phone ringing inside, believed the patient answered the phone and thought the patient and spouse could both be heard speaking to each other but the sound was muffled, and they did not answer/address the nurse. RN 1 attempted to call back a few times, but ‘kept getting busy signals’ and suspected the patient and spouse had not properly hung up/disconnected their cordless phone handset. RN 1 indicated had returned to the home the following Monday, 02-19-2024, but this time could hear the phone just continuing to ring from the outside. When queried as to a back-up plan when the patient could not be reached the first time, the Clinical Director indicated there was not a plan, and a follow-up nursing visit was not attempted over that weekend, nor had a follow-up nursing visit been considered. When queried as to whether there was concern in light of the fact the caregiver, who was normally communicative (by the agency’s account and by the account of Entity G), could not be readily reached, should have alerted the agency and prompted further action or follow-up on the agency’s part, RN 1 and the Clinical Director indicated affirmatively this should have alerted the agency. RN 1 then indicated, ‘I wouldn’t have changed anything’ they had done. On 06-14-2024 at 2:22 PM, LPN 1 was interviewed after a home visit for a wound vac dressing change with Patient #8. When queried as to how often wound vacs needed to be changed indicated according to doctors orders but that this was usually ordered as three times per week, Mondays, Wednesdays, and Fridays. When queried as to why it was important the wound vac dressing changes were performed timely indicated there would be risk for the good tissue to grow into the black foam, infection, or the machine could malfunction. And when queried as to what actions would be taken if a wound vac patient could not be reached for a regularly scheduled skilled nursing visit, LPN 1 indicated would look in the system for other contacts, call the office, call the physician, look for a vehicle at the home, ask for a welfare check to be done, and seek guidance from their supervisor. 6. On 06-14-2024 at 4:57 PM, the Clinical Director and the Alternate Clinical Director were informed of infection prevention breaches that occurred during the home observations for Patient #4 and Patient #8, related to poor aseptic technique during wound vac dressing changes. The Clinical Director indicated understanding that there were now two potentially contaminated wounds in the field and then indicated to the Alternate Clinical Director they ‘needed to get those changed’. On 06-17-2024 at 11:30 AM, the Administrator, Clinical Director, and Alternate Clinical Director were queried as to actions taken and outcome for Patients #4 and #8 after being notified of breaches in infection prevention during the wound care provided three days prior. The Clinical Director indicated that the patient’s physicians had not been notified, the patients had not been seen, and could not answer if either patient was currently receiving antibiotic therapy. The Clinical Director indicated the patients’ physicians should have been contacted on Friday, but indicated both patients were scheduled for nursing visits today.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interviews, the agency failed to ensure clinicians followed the agency’s policy on completion of the documentation of services they provided on the day the service was rendered in 4 of 6 active clinical records reviewed. (Employee: RN 1, RN 2, LPN 1 and LPN 2) Findings include: 1. A review of an undated policy titled, ‘CLINICAL DOCUMENTATION C-680’ revealed, “... 5. Documentation of services ordered on the plan of care will be completed the day service is rendered ... “. 2. A review of the clinical record for Patient #3 revealed two (2) documents titled “Home Health Care Certification and Plan of Care for the certification periods of 04/11/2024 through 06/09/2024 signed by the Director of Nursing on 04/16/2024 and the 2nd for the certification period of 06/10/2024 through 08/08/2024 signed by the Alternate Director of Nursing on 06/12/2024. Patient #3 diagnoses included but were not limited to Pressure ulcer of other site Stage 2 (partial thickness loss of dermis [middle layer of skin] presenting as a shallow open area with a red or pink wound bed, without slough or bruising] and Abrasion of lower back and pelvis. For the certification period of 04/16/2024 through 06/09/2024 Patient #3 was to receive skilled nursing visits 1 time a week, physical therapy 1 time a week for 1 week, 2 times a week for 6 weeks, and 1 time a week for 1 week. For the certification period of 06/10/2024 through 08/08/2024 Patient #3 was to receive skilled nursing 2 times a week for 9 weeks, and physical therapy 2 times a week for 8 weeks. Further review of the clinical record for Patient #3 evidenced skilled nursing visits and when the clinicians completed the visit notes: on 04/11/2024 signed by RN 1 on 04/16/2024, on 05/07/2024 signed by RN1 on 05/09/2024, on 05/09/2024 signed by LPN 2 on 05/11/2024, on 05/16/2024 signed by LPN 2 on 05/23/2024, on 05/23/2024 signed by LPN 2 on 05/28/2024, on 06/4/2024 signed by LPN 2 on 06/06/2024, and on 06/07/2024 signed by RN 1 on 06/11/2024. The Clinical Record failed to evidence the skilled nursing documentation was completed on the day services were rendered. 2. A review of the clinical record for Patient #4 revealed two (2) documents titled “Home Health Care Certification and Plan of Care” for the certification periods of 04/10/2024 through 06/08/2024 signed by the Clinical Director on 04/16/2024 and the 2nd for the certification period of 06/09/2024 through 08/07/2024 signed by the Alternate Clinical Director on 06/11/2024. Patient #4’s diagnoses included but were not limited to Cellulitis of the buttock (a deep infection of the skin), Pressure ulcer of left buttock stage 4 (Full-thickness skin loss extends through the fascia[thin casing of connective tissue that surrounds and holds every organ, blood vessel, bone, nerve fiber and muscle in place] with considerable tissue loss), and Pressure ulcer of Left heel, stage 3 (full thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon, or muscle is not exposed). Patient #4 was to receive skilled nursing visits for the certification period of 04/10/2024 through 06/08/2024 3 times a week and for the certification period of 06/09/2024 through 08/07/2024 wound care was to be performed 2 times a week. Further review of the clinical record for Patient #4 evidenced the following skilled nursing visits and when the clinicians completed the visit notes were: on 04/10/2024 signed by RN 1 on 04/15/2024, on 04/15/2024 signed by RN 1 on 04/16/2024, on 04/19/2024 signed by LPN 2 on 04/22/2024, on 04/22/2024 signed by LPN 2 on 04/23/2024, on 04/26/2024 signed by LPN 2 on 04/30/2024, on 04/29/2024 signed by LPN 1 on 05/03/2024, on 05/03/2024 signed by LPN 1 on 05/07/2024, 0n 05/06/2024 signed by LPN 1 on 05/11/2024, on 05/08/2024 signed by RN 3 on 05/09/2024, on 05/10/2024 signed by LPN 1 on 05/14/2024, on 05/13/2024 signed by LPN 1 on 05/14/2024, on 05/17/2024 signed by RN 3 on 05/18/2024, on 05/20/2024 signed by LPN 1 on 05/30/2024, on 05/24/2024 signed by LPN 1 on 05/30/2024, on 05/27/2024 signed by LPN 1 on 05/28/2024, on 05/31/2024 signed by LPN 1 on 06/03/2024, on 06/03/2024 signed by LPN 1 on 06/06/2024, on 06/07/2024 signed by RN 3 on 06/11/2024, and on 06/12/2024 signed by RN 3 on 06/13/2024. The Clinical Record failed to evidence the skilled nursing documentation was completed on the day services were rendered. 3. A review of the clinical record for Patient #6 revealed a document titled “Home Health Care Certification and Plan of Care” signed by the Alternate Clinical Director and dated 04/25/2024 for the certification period of 04/25/2024 through 06/23/2024. Patient #6’s diagnoses included but were not limited to Disruption of external operation (surgical) wound (surgical complication where a surgery wound reopens, either internally or externally). Patient #6 was to receive skilled nursing visits 2 times a week for wound care/dressing change. Further review of the clinical record evidenced the following skilled nursing visits and when the clinician completed the visit notes were: on 04/25/2024 signed by RN 1 on 04/29/2024, on 04/29/2024 signed by RN 1 on 05/01/2024, on 05/06/2024 signed by RN 1 on 05/08/2024, on 05/17/2024 signed by LPN 1 on 05/18/2024, on 05/24/2024 signed by RN 1 on 05/25/2024, on 05/27/2024 signed RN 1, on 05/31/2024 signed by RN 1 on 06/01/2024, on 06/03/2024 signed by RN 1 on 06/05/2024, and on 06/10/2024 signed by LPN 2. The Clinical Record failed to evidence the skilled nursing documentation was completed on the day services were rendered. 4. A review of the clinical record for Patient #10 revealed a document titled “Home Health Care Certification and Plan of Care” signed by the Alternate Clinical Director and dated 05/30/2024 for the certification period of 05/27/2024 through 07/25/2024. Patient #10’s diagnoses included but were not limited to Encounter for change or removal of surgical wound dressing and Encounter for orthopedic aftercare following surgical amputation. Patient #6 was to receive skilled nursing visits 2 times a week for wound care assessment. Further review of the clinical record evidenced the following skilled nursing visits and when the clinicians completed the visit notes were: on 05/27/2024 signed by RN 1 on 05/28/2024, on 05/29/2024 signed by RN 1 on 06/02/2024, on 06/10/2024 signed by RN 1 on 06/11/2024, and on 06/12/2024 signed by RN 1 on 06/14/2024, The Clinical Record failed to evidence the skilled nursing documentation was completed on the day services were rendered. On 06/14/2024 at 8:39 AM, RN 3 indicated they were to have their documentation completed within 24-48 hours. On 06/14/2024 at 2:45 PM, LPN 2 indicated they were to have their documentation completed within 24-48 hours. On 06/14/2024 at 9:03 AM, RN 1 indicated they were to have their documentation completed within 24-48 hours. On 06/17/2024 at 11:39 AM, the Clinical Director indicated all clinicians should have their documentation completed within 24-48 hours.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on record review and interview the agency failed to ensure clinicians followed the agency’s policy when performing wound care with the use of negative pressure wound therapy in 1 of 3 home visits. (LPN 2) Findings include: 1. A review of a policy titled ‘NEGATIVE PRESSURE WOUND THERAPY POLICY’ dated May 17, 2023 revealed, “... 8. General application process: ... e. Select foam type to the size and characteristics of the wound, and place gently into the wound ... “. 2. A review of the clinical record for Patient #4 revealed two (2) documents titled “Home Health Care Certification and Plan of Care” for the certification period 06/09/2024 through 08/07/2024 signed by the Alternate Clinical Director on 06/11/2024. Patient #4’s diagnoses included but were not limited to Cellulitis of the buttock (a deep infection of the skin), Pressure ulcer of left buttock stage 4 (Full-thickness skin loss extends through the fascia[thin casing of connective tissue that surrounds and holds every organ, blood vessel, bone, nerve fiber and muscle in place] with considerable tissue loss), and Pressure ulcer of Left heel, stage 3 (full thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon, or muscle is not exposed). Patient #4 was to receive skilled nursing wound care visits, “Left buttock cleanse with normal saline, use skin prep for peri-wound, cover with transparent dressing, Negative pressure wound therapy (NPWT) (Negative Pressure Wound Therapy also known as ‘wound vac’: a broad term describing a unique system that aids the optimization of wound healing through the application of vacuum pressure to reduce inflammatory drainage and promote the growth of healthy tissue), type of dressing, black foam, and NPWT settings continuous 125 mmHg (millimeters of mercury)”. On 06/14/2024 at 1:53 PM during a home observation with LPN 2 for Patient #4’s stage 4 left buttock wound care. LPN 2 created a barrier on Patient #4’s bed, hand hygiene performed, and reached into their bag for scissors, alcohol pads, and a marker. LPN 2 reached into a box by Patient #4’s bed to retrieve the NPWT kit, without using hand hygiene, reached into their nursing bag for the box of gloves and placed them on the foot of Patient #4’s bed, then performed hand hygiene, donned gloves, placed a barrier under Patient #4’s buttock, touched the clean barrier before getting back into their nursing bag for more barriers. LPN 2 cleaned their scissors with an alcohol pad, turned the NPWT pump off, doffed their gloves, with no hand hygiene, donned a pair of gloves, and opened gauze dressing packages, and normal saline syringes. At 2:03 PM LPN 2 unhooked the tubing from the dressing, with the end of the tubing attached to the machine lying on Patient #4’s bed, LPN 2 removed the dressing. Once removed, LPN 2 doffed their gloves, reached into their nursing bag retrieved packaged Q-tips, performed hand hygiene, and donned gloves. Using a Q-tip and a measuring device to obtain measurements of the wound, doffed their gloves with no hand hygiene, picked up the marker, and marked on the measuring tape the measurements of the wound. LPN #2 donned gloves, using normal saline syringes began washing the wound, using gauze to dry the wound, doffed their gloves, and performed hand hygiene. LPN 2 donned gloves, using skin prep around the wound, then doffed their gloves. LPN 2 donned a pair of gloves without performing hand hygiene, opened the NPWT kit, cut strips of a clear dressing for the drape placement around the wound, and placed them around the peri-wound. LPN 2 began cutting a long strip (approximately 12 inches) of the black sponge. As LPN 2 attempted to place the sponge into the wound bed with their gloved finger, some of the sponge came out, and they pushed it back into the wound with their finger, and continued to pack the wound with the sponge with their finger until it appeared to be full, took the tail of the the black sponge approximately four inches and ran it up Patient #4’s buttock toward their waist, proceeded to cover the wound with a clear dressing, cut a hole in the clear dressing at the end of the sponge, and used the attached tubing adhesive drape sealed the tubing on top of the dressing, and reapplied the NPWT to the dressing and turned the pump on. On 06/17/2024 at 10 AM, a review of the Personnel Record for LPN 2 was conducted, evidenced a hire date of 10/23/2023 and failed to evidence training specific to NPWT. On 06/14/2024 at 2:45 PM, LPN 2 indicated they should have used a Q-Tip to push the sponge into the wound. When queried if they normally cut a long strip of foam, they indicated they do and pack it into the wound. When queried if they had been trained on how to properly use NPWT, they indicated they had not received official training but had job shadowed, and could reach out to the case manager if there were any tasks they were unsure of. On 06/14/2024 at 3:59 PM, the Clinical Director indicated LPN 2 should have not used their finger to put the sponge into the wound, and should have cut the sponge to fit the wound, not packed the wound with the sponge. The Clinical Director indicated that the agency needed to have a Registered Nurse (RN) follow up with the visit. On 06/17/2024 at 9:11 AM, Person K with Entity J indicated they were familiar with Patient #4, indicated the agency hadn’t reached out to them since 06/14/2224, and they were not comfortable with giving answers regarding wound care vac dressing changes, they would have their Supervisor return this writer’s phone call. On 06/17/2024 at 11:18 AM, this writer requested from the Clinical Director training or in-services for NPWT which LPN 2 had completed. On 06/17/2024 at 11:33 AM, the Clinical Director indicated they had not notified the Physician of the visit nor had an RN follow-up over the weekend. On 06/17/2024 at 3:13 the Clinical Director indicated LPN 2 had not received any training or in-services for NPWT.”