Every finding on record at Oswego Health Home Care, LLC

This Statement of Deficiency is the result of the complaint investigation for complaint #1416134 conducted concurrently with post-certification visit on 07/15/25 - 07/23/25. During the survey the following were reviewed: 4 patient records, the complaint log, and the agency's complaint investigation. Interviews were conducted with the Director of Patient Services, the RN Team Manager, the Quality Assurance Manager, and staff members. The complaint was substantiated. The following deficiencies were identified: G 486 Protect patient during investigation, G 576 All orders recorded in the plan of care, G 580 Only as ordered by a physician, and G 584 verbal orders

Protect patient during investigation CFR(s): 484.50(e)(1)(iii) (iii) Take action to prevent further potential violations, including retaliation, while the complaint is being investigated. This ELEMENT is not met as evidenced by: Based on record review, including a review of the agency's Complaint Investigation, and interviews with pertinent staff members during the survey, it was determined for 1 of 4 patients (patient #2), the home health agency did not take action to prevent further potential violations while the complaint was being investigated. Specifically, the wound care center reported a complaint regarding how the agency was entering orders for patient #2 and there was no documented evidence the staff re-education, recommended by the Quality Assurance (QA) Manager, was completed and no documented evidence the agency reviewed other patients to ensure they were not affected and not at risk for the same potential violations. Findings include: Patient #2 was most recently admitted to the agency on 02/15/25 with diagnoses of right foot stage 3 pressure ulcer, scrotal/sacrum abrasion, quadriplegia, and neurogenic (nerve damage causing dysfunction) bowel and bladder. The 6/25/2025 agency's investigation documented they received a complaint on 6/13/2025 from the wound care center (WCC). The WCC was unwilling to sign physician orders as the orders the home care agency sent for signature did not match the orders the WCC sent electronically. The agency's investigation documented: - Chart review revealed WCC orders were routinely incomplete or lacked details that the home care agency required to meet their requirements. - Typically, when the agency identified incomplete orders, telephone calls were made to the provider for verbal orders and those calls were documented in the patient activity section of the electronic medical record. - With these cases, calls to the provider were documented in the patient activity section of the electronic medical record but the details documented did not support all of the changes made to the orders by the agency's clinicians. - The medical provider at the WCC refused to sign orders that the agency sent to them dated 5/25/2025 and notified the agency they were dissatisfied. The resolution on the 6/25/2025 agency investigation included: - The orders the WCC refused to sign were discussed by the WCC and the RN Team Manager. They were clarified, approved, and signed. - The agency identified an opportunity for improvement when documenting verbal orders. - The plan was to coach the clinician involved with the case as well as to complete agency-wide education with clinical staff. - The agency and WCC would work together to develop an approach to taking and receiving orders. The agency investigation was documented as reported by the Quality Assurance (QA) Manager and signed by the Director of Patient Services (DPS). During an interview on 7/17/2025 at 12:08 PM, the QA Manager stated they were asked to review patient #2's medical record after the WCC refused to sign orders the agency entered for the patient. During the investigation, they found that when agency nurses called the WCC for order clarification, the documentation in the medical record was lacking and did not always support the order that was entered. They completed their chart review on 6/18/2025 and emailed the chart review and their findings to the Administrative team. They recommended the RN Case Manager (RN) who mainly cared for patient #2 to be re-educated; recommended auditing additional patients' records to determine if there was a larger issue, and recommended re-education of all clinical staff. They stated the follow-up with the RN involved would be done by the DPS or Team Manager; they were told the Administrative team already reviewed additional patient records and therefore did not do that themself, and thought the staff re-education was going to be completed at a team meeting in August 2025. The QA Manager stated there was a meeting earlier this week with the agency nurses but this topic did not come up. On 7/18/2025 at 10:08 AM, the RN Team Manager stated in an interview, a couple of months ago issues arose between the WCC and the agency when the WCC was unwilling to sign orders entered by the agency's clinicians. The WCC accused the agency nurses of entering orders without having a conversation with anyone at the WCC. The Team Manager was notified there was a concern by the Health Information Technician when the WCC refused to sign orders entered by agency clinicians. They thought this affected somewhere between 2 and 5 patients but did not recall the exact number. The Team Manager stated the agency-wide education had not been done yet as a result of this investigation but there was a meeting earlier this week with the agency nurses and the topic of verbal orders was discussed. The DPS was going to follow-up with the specific RN Case Manager who cared for patient #2. The Team Manager stated no other patients' records were reviewed as part of this investigation. On 7/18/2025 at 11:17 AM, The DPS stated in an interview, the QA Manager was asked to complete an audit of patient #2's record when the Manager at the WCC called and reported a concern with orders not matching what they sent initially for the patient. The QA Manager planned to audit more records but they were not sure if that occurred yet. The agency investigation identified they had been lax in some instances with obtaining verbal orders and they sent out a re-education to staff via email and also planned to complete re-education at a meeting in August 2025. The RN who mostly cared for this patient was coached following the investigation but according to their process, verbal coaching is not documented. Failure to prevent further potential violations by reviewing other potentially affected patients and completing staff re-education while a complaint was being investigated, has the potential to cause adverse patient outcomes.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with the Director of Patient Services, RN Team Manager, and pertinent staff members, the agency failed to record all orders, including verbal orders, for 3 of 4 patients (patients #2, 3, and 4), the failed to update the patients' plan of care to accurately include all orders received from the health care provider. 2. Patient #3 was admitted to the agency on 05/07/25 with diagnoses that included chronic venous hypertension, non-pressure ulcers to the bilateral lower extremities, laceration to the left thigh, and dementia. The 04/29/25 referral from the provider at the Wound Care Center stated: - the patient had not been moving as much in the home, became deconditioned, and was sitting with legs dependent, causing swelling and leaking from wounds that would soak shows and socks (page 1) - additional orders/instructions included elevate legs to the level of the heart or above 30 minutes daily and/or when sitting (page 5) - the patient had deconditioning and would benefit from physical therapy (PT) and occupational therapy (OT) (page 8) The 04/30/25 Face to Face document from provider stated home health services including nursing, physical therapy, and occupation therapy were medically necessary. On 05/07/25, the registered nurse (RN) visited the patient and performed the start of care evaluation. The RN documented that the patient was mostly wheelchair bound with transfers from bed to wheelchair to chair and PT evaluation “would be a good idea.” There was no documentation if OT was offered. The RN also documented there was no edema present. There was no documentation to support if the patient was elevating lower extremities or teaching was done related to elevating lower extremities. The 05/07/25 Plan of Care failed to include orders for OT evaluation or to elevate lower extremities. On 07/17/25 at 9:30 a.m., the surveyor interviewed the RN who conducted the start of care evaluation. The RN reported they recalled the patient but did not recall reading anything about elevating lower extremities or occupational therapy in the referral. The RN reported that they should have entered the order to elevate lower extremities. The RN requested time to review the notes they took during the visit. At 10 a.m., the RN called the surveyor back and reported that they did not find any additional information about these items their notes and may have “missed some things.” On 07/22/25 at 1:30 p.m., the surveyor reviewed the record with the Administrator, Team Manager, and Director of Patient Services (DPS). The DPS reported that the agency does not consider Wound Care Center statements under “additional orders/instructions” as orders because sometimes they include things that may not apply to patients. On 07/23/25 at 8:40 a.m., the DPS gave the surveyor copies of multiple documents including: - 04/30/25 Face to Face Encounter that stated PT, OT, and nursing were medically necessary - 05/07/25 Plan of Care with notation that the provider refused to sign despite the Wound Care Center was the referral source and indicated skilled nursing, PT, and OT with verbal authorization given - highlighted statement for another patient under the additional orders/instructions to justify an order for that patient This information does not change the above findings. 3. Patient #6 was admitted to the agency on 04/14/25 with diagnoses that included peripheral venous insufficiency, ulcer of right lower leg, cellulitis of right lower leg, and diabetes with neuropathy. The 04/10/25 referral for home care services included: Under additional orders/instructions: - avoid standing for long periods of time, elevate legs to the level of the heart or above for 30 minutes daily and/or when sitting - Do not get the dressing or wound wet. Personal cleansing must be done in sponge bath fashion. Leave dressing in place Under the home health section, home care to admit patient for skilled nursing services to change dressing twice a week The 04/14/25 Plan of Care: - included an order that patient “may shower with entire dressing covered, do not get wet.” - failed to include order to elevate legs or affected extremity. There was no documentation the clinician obtained an order for the patient to shower if the dressing did not get wet. On 07/22/25 at 1:30 p.m., the surveyor reviewed the record with the Administrator, Team Manager, and Director of Patient Services (DPS). The DPS reported that the agency does not include Wound Care Center statements under “additional orders/instructions” as orders because sometimes they include things that may not apply to patients. On 07/23/25 at 08:40 a.m., the DPS reported to the surveyor that they thought the order for sponge bathing was subjective and did not need clarification as long as the dressing did not get wet. The DPS gave the surveyor a copy of an order from the wound care center dated 05/28/25 stating under additional orders/instructions “remove dressing and shower on days home care comes in.” Failure to accurately add all orders received from the medical provider leaves the patient population at risk for unmet needs and negative outcomes. Patient #2 was most recently admitted to the agency on 02/15/25 with diagnoses of right foot stage 3 pressure ulcer, scrotal/sacrum abrasion, quadriplegia, and neurogenic (nerve damage causing dysfunction) bowel and bladder. The agency failed to update the plan of care as ordered by the wound care clinic (WCC) specialist. On 03/05/25 the patient was seen at the WCC, who electronically sent the following wound care orders to the agency: - Right foot wound: cleanse with antibacterial soap and water. Apply moistened collagen dressing directly to wound bed, and cover with an inch thick of 4x4 gauze pads. Apply Kerlix and ACE wrap. Apply Circaid Juxta Lite compression wrap. Wound care to be completed every other day. - Scrotum/sacrum wound: cleanse with antibacterial soap and water. Apply thin layer of Silvadene cream, to wound bed only, followed by Hydrofera Blue Transfer to the entire wound. Cover with Allevyn Gentle Border Sacrum dressing. Wound care to be completed every other day. - Patient to wear compression stockings to bilateral lower extremities. The 02/15/25-04/15/25 Plan of Care, included the following wound care orders dated 03/07/25: - Right foot wound: cleanse with NS (normal saline) or soap and water (whichever is available), apply moistened collagen, and cover with bordered foam on Sunday, Monday, Wednesday, Friday, and as needed if soiled. - Scrotal/sacrum wound: cleanse with soap and water and apply Hydrofera Blue Transfer. Wrap with Kerlix and ACE wrap on Sunday, Monday, Wednesday, Friday, and as needed if soiled. Patient to wear Circaids (compression stockings) at bedtime. The wound care orders included in the plan of care were not in accordance with the care ordered by the wound care clinic specialist as follows: - Right foot wound: the agency included NS or soap and water (whichever was available) to clean the foot wound rather than the antibacterial soap which was ordered; failed to include using a thick inch of 4x4 gauze pads to cover the wound after the collagen was applied; failed to include applying Kerlix and an ACE wrap to the foot; and failed to include using the Circaid Juxta Lite compression wrap to the right leg. - Scrotal/sacrum wound: failed to include cleansing with an antibacterial soap, applying the Silvadene cream to the wound bed after cleaning, and applying an Alleyn Gentle Border. The order erroneously included Kerlix and ACE wraps, as well as the wearing of compression stockings, which were to be applied to the foot wound not the scrotal wound. - Care for both wounds were ordered by the wound care specialist to be completed every other day, the plan of care did not reflect an every other day schedule. On 04/28/25 the WCC ordered: - Sacral/gluteal wound: apply white foam to wound bed then cover with black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC (no wound cleansing agent provided on order). On 04/30/25, rather than what was ordered, the agency entered the following into the patient’s plan of care: - Sacral/gluteal wound: cleanse wound with Vashe (wound cleaning solution) wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Place white foam in base of sacral wound followed by black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. On 05/12/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply 1 piece of black foam to wound bed. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/13/25, rather than what was ordered, the agency entered the following into the patient’s plan of care: - Sacral/gluteal wound: cleanse wound with Vashe wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Place 1 piece of black foam dressing to wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. On 05/21/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply white foam to tunneled areas at 12:00 and 1:00, and apply black foam over white to fill wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/22/25, rather than what was ordered, the agency entered the following into the patient’s plan of care: - Sacral/gluteal wound: cleanse wound with Vashe wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Apply white foam into wound tunnelling at 12-1:00 and cover with black foam dressing. Attach wound vac to dressing at 125 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. On 06/04/25 the WCC ordered: -Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing and change daily for 1 week. - Right gluteal wound: cleanse wound with antibacterial soap and water. Apply Hydrofera Blue Transfer to entire wound and cover with Allevyn dressing. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 06/05/25, rather than what was ordered, the agency entered the following into the patient’s plan of care: - Sacral/gluteal wound: wound vac on hold. Cleanse wound with NS/Vashe and apply a wet to dry dressing using Kerlix and Vashe. Apply skin prep to surrounding skin and cover with a bordered dressing. Wound care to be done daily. On 06/11/25 WCC ordered: - Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing and change daily for 1 week. - Right gluteal wound: cleanse wound with antibacterial soap and water. Apply Santyl to darkened area of wound bed nickel thick and cover with Allevyn. Wound care to be done daily. On 06/11/25, rather than what was ordered, the agency entered the following into the patient’s plan of care: - Sacral/gluteal wound: wound vac on hold. Cleanse wound with NS/Vashe and apply a wet to dry dressing using Kerlix and Vashe. Apply skin prep to surrounding skin and cover with a bordered dressing. Wound care to be done daily. - Right gluteal wound: cleanse wound with NS/Vashe (whichever is available) and apply Santyl when available. Cover with bordered dressing. Wound care to be done Monday, Wednesday, Friday, and as needed. On 07/17/25, at 12:00 p.m., the surveyor interviewed the skilled nurse about how orders were received and a patient’s plan of care was updated to reflect any changes. The nurse stated orders were forwarded to them from their supervisor. Once received, the nurse reviews them and then enters and/or updates the orders in the patient’s record. The nurse continued to say the old process was if the orders needed to be clarified, they would call the WCC, a patient activity note would be created with details of the clarification, and a supplemental order would be sent out. The new process was now to have their supervisor (RN Team Manager or DPS) reach out to the WCC and get clarifications through email. The nurse was asked why the agency orders continued to say NS/Vashe to clean and Vashe for the wet to dry dressing after an email exchange on 5/6-5/7/25 with the WCC (in which the nurse was involved). The WCC clearly stated antibacterial soap should be used to clean with and NS should be used for the wet to dry dressing. The nurse responded that orders were routinely copied and pasted into the patient's record, therefore the same order was probably still being utilized. On 07/17/25, at 3:15 p.m., the surveyor interviewed the wound care clinic provider/specialist regarding orders. The provider stated the orders given by the WCC are specific and reflective of what the WCC wants to be done for the wound care. If the order was not specific, the provider would expect the agency to call and get clarification. The provider also stated if a specific product was unavailable and/or if a product substitution wanted to be used, they would expect the agency to call. On 07/18/25, at 10:10 a.m., the surveyor interviewed the agency RN Team Manager regarding orders in general. The Team Manager stated when they received an order, they would forward it to the patient’s nurse case manager, who would then enter and/or update the order. When asked what the process would be if there was a question or clarification needed on an order, the Team Manager stated the nurse would call the provider for clarification and then document the exchange in the patient’s activity notes. The Team Manager was then asked what the process was if specific supplies ordered were unavailable. The Team Manager stated the nurse should call and obtain an interim order, then, if the supplies could not be obtained within a few days, the nurse would need to get a new order.

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 review of clinical records and interviews with agency staff for 2 of 4 patients (patients #2 and 3) the agency failed to ensure treatments are administered in accordance with physician orders. 1. Patient #2 was most recently admitted to the agency on 02/15/25 with diagnoses of right foot stage 3 pressure ulcer, scrotal/sacrum abrasion, quadriplegia, and neurogenic (nerve damage causing dysfunction) bowel and bladder. The agency staff failed to follow orders provided by the wound care specialist. On 03/05/25 the wound care center (WCC) electronically sent the following wound care orders to the agency: - Right foot wound: cleanse with antibacterial soap and water. Apply moistened collagen dressing directly to wound bed, and cover with an inch thick of 4x4 gauze pads. Apply Kerlix and ACE wrap. Apply Cicaid Juxta Lite compression wrap. Wound care to be completed every other day. - Scrotum/sacrum wound: cleanse with antibacterial soap and water. Apply thin layer of Silvadene cream, to wound bed only, followed by Hydrofera Blue Transfer to the entire wound. Cover with Allevyn Gentle Border Sacrum dressing. Wound care to be completed every other day. The care provided by agency nurses was not in accordance with the care ordered by the wound care clinic specialist as follows: - The patient was not seen by the agency nurse for wound care until 03/12/25, 7 days after the order for every other day wound care was received - On 03/12/25 the patient was seen by the RN Case Manager (RN) who performed the following wound care both the right foot wound and scrotal/sacrum wound: cleansed with soap and water, applied Hydrofera Blue, and covered with a bordered dressing. The RN failed to notify the WCC they were not using 1” thick 4x4 gauze pads to the foot wound or applying the Kerlix and ACE wrap; and for the scrotal/sacrum wound they were not using the Silvadene cream prior to placing the Hydrofera Blue on the wound. On 04/28/25 the WCC ordered: Sacral/gluteal wound: apply white foam to wound bed then cover with black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC (no wound cleansing agent provided on order). On 04/30/25 the RN performed the following wound care to the sacral/gluteal wound: cleansed the wound with Vashe soak for 5-10 minutes, prepped surrounding skin with skin prep, placed 1 piece of Aquacel AG to upper area, placed 1 piece of white foam into base of wound followed by black foam to fill the wound, covered wound with vac drape, and connected to wound vac at 150 mm/hg continuous pressure. The RN did not provide care per the orders and there was no evidence the nurse called the WCC to obtain an order to: - cleanse with Vashe wash soak for 5-10 minutes prior to wound care - apply skin prep to surrounding skin - apply Aquacel AG to the superficial open area On 05/05/25 the WCC ordered: - Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing. Change daily for 1 week. The following email exchange then took place between the agency (RN Team Manager) and the WCC: - 05/06/25 5:35 p.m.: The agency asked the WCC to clarify the orders received on 05/05/25 in regard to the wound cleansing agent, the product to be used for the wet to dry dressing, and what the wound should be covered with. - 05/07/25 8:10 a.m.: The WCC emailed the agency the 05/05/25 order, which had previously been sent. - 05/07/25 8:38 a.m.: The agency asked the WCC if normal saline (NS) should be used for the wet to dry dressing. -05/07/25 9:26 a.m.: The WCC informed the agency that normal saline should be used for the wet to dry dressing and antibacterial soap should be used to clean the wound. On 05/07/25, at 8:15 a.m., the patient was seen by the RN who performed the following wound care to the sacral/gluteal wound: cleansed wound with NS, applied wet kerlix into wound (solution used not documented), and covered with bordered gauze. The RN failed to follow the WCC orders by cleansing the wound with NS instead of antibacterial soap. There was no evidence the nurse called the WCC to clarify/obtain an order for the type of dressing the wound should be covered with. On 05/12/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply 1 piece of black foam to wound bed. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/13/25, without any evidence of a verbal/revised order inclusive of the following, the agency created and sent the following supplemental order to the WCC: - Sacral/gluteal wound: cleanse wound with Vashe wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Place 1 piece of black foam dressing to wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. On 05/14/25 the RN performed the following wound care to the sacral/gluteal wound: cleansed wound with NS, prepped surrounding skin with skin prep, placed one piece of foam, and connected to wound vac at 125 mm/hg continuous pressure. The RN failed to follow the WCC order when they cleansed the wound with NS instead antibacterial soap and water, and applied skin prep, which were included in the agency documented orders but not included in the WCC orders. On 05/21/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply white foam to tunneled areas at 12:00 and 1:00 and apply black foam over white to fill wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/22/25, without any evidence of a verbal/revised order, the agency implemented an order other than the above: On 05/23/25, and 5/26/25 the nurses (RN and licensed practical nurse) failed to follow the WCC orders by: - cleansing wound with NS/Vashe instead of antibacterial soap prior to wound care - applying skin prep to skin surrounding wound On 06/04/25 the WCC ordered: -Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing and change daily for 1 week. - Right gluteal wound: cleanse wound with antibacterial soap and water. Apply Hydrofera Blue Transfer to entire wound and cover with Allevyn dressing. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 06/05/25, without evidence of any changes to the orders by the WCC, the agency created and sent a different order to the WCC: The order was sent back to the agency, on an unknown date, with a notation of “not ours” handwritten on it. On 06/06/26 the RN cleansed the wound with NS instead antibacterial soap and water and applied skin prep, which was included in the agency documented orders, but not included in the WCC orders. On 06/05/25 starting at 8:05 a.m. there was an email exchange between the WCC and the agency. The WCC emailed the agency asking them to review and compare the orders they sent (WCC) to the orders the agency had because the agency orders appeared to have items in it that the WCC orders did not. The agency responded the orders they had appeared to match the WCC orders with the exception of what to clean the wound with. The WCC directed the agency to clean with antibacterial soap in which the agency responded they would let the nurse know so the necessary changes to the order could be made. On 07/17/25, at 12:00 p.m., the RN Case Manager (RN) was interviewed regarding some of the discrepancies found between WCC orders and agency orders that were entered into the patient’s record. For example: - When asked about the WCC’s 03/05/25 order including the use of 1” thick of 4x4 gauze pads and a Kerlix and ACE wrap but the agency orders did not, the RN responded the patient’s shoes would not fit with all that padding and that the WCC doesn’t understand that insurance only covers so many supplies. When the RN was asked if they called the WCC to discuss those concerns, the RN responded probably not unless there was a concern about wound drainage. - When asked about multiple WCC orders listing antibacterial soap and water as a wound cleanser and agency orders listing NS or Vashe wash, the RN stated the patient had several bottles of Vashe in the home and that it’s just a cleaning agent. When the RN was asked if they would call the WCC for that type of change, the RN stated they would, but if there was nothing noted in the patient’s activity notes then they must have forgotten to document it. - The RN was asked why the agency orders continued to say NS/Vashe to clean and Vashe for the wet to dry dressing after an email exchange on 5/6-5/7/25 with the WCC (in which the RN was involved). The WCC clearly stated antibacterial soap should be used to clean with and NS should be used for the wet to dry dressing. The RN responded that orders were routinely copied and pasted into the patient's record, therefore the same order was probably still being utilized. On 07/17/25, at 3:15 p.m., the surveyor interviewed the WCC provider/specialist regarding orders. The provider stated the orders given by the WCC are specific and reflective of what care the WCC wants done. The provider also stated if a specific product was unavailable and/or if a product substitution wanted to be used, they would expect the agency to call for a revised order prior to providing care other than what was ordered. 2. Patient # 3 was admitted to the agency on 05/07/25 with diagnoses that included chronic venous hypertension, non-pressure ulcers to the bilateral lower extremities, laceration to the left thigh, and dementia. 05/27/25 orders from the wound care center (WCC) included the following: - Dermasyn hydrogel dressing was ordered 05/27/25, if it is not in patient’s house by the time home care is scheduled for a dressing change, you may use the Collagen. - Right lower leg cleanse with antibacterial soap and water, Dermasyn hydrogel, apply 4x4 gauze over the wound, apply unna boot with calamine, coban self-adhesive wrap apply over unna boot. Home care to complete Wednesday and Friday, wound care center on Mondays. There were no orders for the trochanter wound on these orders from the WCC. Orders with a 05/28/25 start date entered into the home care electronic medical records as follows: - wound to right lower extremity, wash with soap and water, pat dry, apply hydrogel to wound bed, cover with gauze, apply unna boot toes to knee followed by coban every Wednesday and Friday and as needed for compromise, goes to wound care center Mondays. - left trochanter wound cleanse with soap and water, pat dry, apply hydrogel to wound bed and cover with foam dressing every Wednesday and Friday and as needed for compromise, goes to wound care center Mondays. On the 05/29/25 a registered nurse (RN) visited the patient for wound care and documented: - right lower extremity wound care completed – cleansed with antibacterial soap, patted dry, applied hydrogel to the wound bed then applied unna boot wrap toes to knee and covered with coban. - left trochanter wound cleansed with antibacterial soap, patted dry, applied hydrogel to the wound bed then covered with Allevyn. The order to apply hydrogel to the trochanter wound care order remained active throughout the rest of the home care episode without evidence an order was obtained to apply hydrogel to this wound. On 06/11/25, an RN visited the patient and documented that the trochanter wound was healed and Mepilex was applied per request of family. There is no evidence the nurse spoke with the physician office and obtained an order. On 07/17/25 at 2:30 p.m., the Registered Nurse Case Manager (RN) was interviewed about the wound care orders and treatments. The RN reported that if the orders entered into the home care electronic medical record did not match, the RN would have called the wound care center directly to clarify and this was done more than once and the RN documented this under patient activity. On 07/22/25 at 1:30 p.m., the record was reviewed with the Administrator, Director of Patient Services, and RN Team Manager. No further information was provided. Failure to administer treatments as ordered by the medical provider has the potential to place patient at risk for negative outcomes. 1. Patient #2 was most recently admitted to the agency on 02/15/25 with diagnoses of right foot stage 3 pressure ulcer, scrotal/sacrum abrasion, quadriplegia, and neurogenic (nerve damage causing dysfunction) bowel and bladder. The agency staff failed to follow orders provided by the wound care specialist. On 03/05/25 the wound care center (WCC) electronically sent the following wound care orders to the agency: - Right foot wound: cleanse with antibacterial soap and water. Apply moistened collagen dressing directly to wound bed, and cover with an inch thick of 4x4 gauze pads. Apply Kerlix and ACE wrap. Apply Cicaid Juxta Lite compression wrap. Wound care to be completed every other day. - Scrotum/sacrum wound: cleanse with antibacterial soap and water. Apply thin layer of Silvadene cream, to wound bed only, followed by Hydrofera Blue Transfer to the entire wound. Cover with Allevyn Gentle Border Sacrum dressing. Wound care to be completed every other day. The care provided by agency nurses was not in accordance with the care ordered by the wound care clinic specialist as follows: - The patient was not seen by the agency nurse for wound care until 03/12/25, 7 days after the order for every other day wound care was received - On 03/12/25 the patient was seen by the RN Case Manager (RN) who performed the following wound care both the right foot wound and scrotal/sacrum wound: cleansed with soap and water, applied Hydrofera Blue, and covered with a bordered dressing. The RN failed to notify the WCC they were not using 1” thick 4x4 gauze pads to the foot wound or applying the Kerlix and ACE wrap; and for the scrotal/sacrum wound they were not using the Silvadene cream prior to placing the Hydrofera Blue on the wound. On 04/28/25 the WCC ordered: Sacral/gluteal wound: apply white foam to wound bed then cover with black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC (no wound cleansing agent provided on order). On 04/30/25 the RN performed the following wound care to the sacral/gluteal wound: cleansed the wound with Vashe soak for 5-10 minutes, prepped surrounding skin with skin prep, placed 1 piece of Aquacel AG to upper area, placed 1 piece of white foam into base of wound followed by black foam to fill the wound, covered wound with vac drape, and connected to wound vac at 150 mm/hg continuous pressure. The RN did not provide care per the orders and there was no evidence the nurse called the WCC to obtain an order to: - cleanse with Vashe wash soak for 5-10 minutes prior to wound care - apply skin prep to surrounding skin - apply Aquacel AG to the superficial open area On 05/05/25 the WCC ordered: - Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing. Change daily for 1 week. The following email exchange then took place between the agency (RN Team Manager) and the WCC: - 05/06/25 5:35 p.m.: The agency asked the WCC to clarify the orders received on 05/05/25 in regard to the wound cleansing agent, the product to be used for the wet to dry dressing, and what the wound should be covered with. - 05/07/25 8:10 a.m.: The WCC emailed the agency the 05/05/25 order, which had previously been sent. - 05/07/25 8:38 a.m.: The agency asked the WCC if normal saline (NS) should be used for the wet to dry dressing. -05/07/25 9:26 a.m.: The WCC informed the agency that normal saline should be used for the wet to dry dressing and antibacterial soap should be used to clean the wound. On 05/07/25, at 8:15 a.m., the patient was seen by the RN who performed the following wound care to the sacral/gluteal wound: cleansed wound with NS, applied wet kerlix into wound (solution used not documented), and covered with bordered gauze. The RN failed to follow the WCC orders by cleansing the wound with NS instead of antibacterial soap. There was no evidence the nurse called the WCC to clarify/obtain an order for the type of dressing the wound should be covered with. On 05/12/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply 1 piece of black foam to wound bed. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/13/25, without any evidence of a verbal/revised order inclusive of the following, the agency created and sent the following supplemental order to the WCC: - Sacral/gluteal wound: cleanse wound with Vashe wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Place 1 piece of black foam dressing to wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. On 05/14/25 the RN performed the following wound care to the sacral/gluteal wound: cleansed wound with NS, prepped surrounding skin with skin prep, placed one piece of foam, and connected to wound vac at 125 mm/hg continuous pressure. The RN failed to follow the WCC order when they cleansed the wound with NS instead antibacterial soap and water, and applied skin prep, which were included in the agency documented orders but not included in the WCC orders. On 05/21/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply white foam to tunneled areas at 12:00 and 1:00 and apply black foam over white to fill wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/22/25, without any evidence of a verbal/revised order, the agency implemented an order other than the above: On 05/23/25, and 5/26/25 the nurses (RN and licensed practical nurse) failed to follow the WCC orders by: - cleansing wound with NS/Vashe instead of antibacterial soap prior to wound care - applying skin prep to skin surrounding wound On 06/04/25 the WCC ordered: -Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing and change daily for 1 week. - Right gluteal wound: cleanse wound with antibacterial soap and water. Apply Hydrofera Blue Transfer to entire wound and cover with Allevyn dressing. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 06/05/25, without evidence of any changes to the orders by the WCC, the agency created and sent a different order to the WCC: The order was sent back to the agency, on an unknown date, with a notation of “not ours” handwritten on it. On 06/06/26 the RN cleansed the wound with NS instead antibacterial soap and water and applied skin prep, which was included in the agency documented orders, but not included in the WCC orders. On 06/05/25 starting at 8:05 a.m. there was an email exchange between the WCC and the agency. The WCC emailed the agency asking them to review and compare the orders they sent (WCC) to the orders the agency had because the agency orders appeared to have items in it that the WCC orders did not. The agency responded the orders they had appeared to match the WCC orders with the exception of what to clean the wound with. The WCC directed the agency to clean with antibacterial soap in which the agency responded they would let the nurse know so the necessary changes to the order could be made. On 07/17/25, at 12:00 p.m., the RN Case Manager (RN) was interviewed regarding some of the discrepancies found between WCC orders and agency orders that were entered into the patient’s record. For example: - When asked about the WCC’s 03/05/25 order including the use of 1” thick of 4x4 gauze pads and a Kerlix and ACE wrap but the agency orders did not, the RN responded the patient’s shoes would not fit with all that padding and that the WCC doesn’t understand that insurance only covers so many supplies. When the RN was asked if they called the WCC to discuss those concerns, the RN responded probably not unless there was a concern about wound drainage. - When asked about multiple WCC orders listing antibacterial soap and water as a wound cleanser and agency orders listing NS or Vashe wash, the RN stated the patient had several bottles of Vashe in the home and that it’s just a cleaning agent. When the RN was asked if they would call the WCC for that type of change, the RN stated they would, but if there was nothing noted in the patient’s activity notes then they must have forgotten to document it. - The RN was asked why the agency orders continued to say NS/Vashe to clean and Vashe for the wet to dry dressing after an email exchange on 5/6-5/7/25 with the WCC (in which the RN was involved). The WCC clearly stated antibacterial soap should be used to clean with and NS should be used for the wet to dry dressing. The RN responded that orders were routinely copied and pasted into the patient's record, therefore the same order was probably still being utilized. On 07/17/25, at 3:15 p.m., the surveyor interviewed the WCC provider/specialist regarding orders. The provider stated the orders given by the WCC are specific and reflective of what care the WCC wants done. The provider also stated if a specific product was unavailable and/or if a product substitution wanted to be used, they would expect the agency to call for a revised order prior to providing care other than what was ordered. 2. Patient # 3 was admitted to the agency on 05/07/25 with diagnoses that included chronic venous hypertension (a condition where the veins in the legs have high blood pressure due to damaged valves that prevent proper blood flow back to the heart), non-pressure ulcers to the bilateral lower extremities, laceration to the left thigh, and dementia. 05/27/25 orders from the wound care center (WCC) included the following: - DermaSyn Hydrogel dressing was ordered 05/27/25, if it is not in patient’s house by the time home care is scheduled for a dressing change, you may use the collagen. - Right lower leg cleanse with antibacterial soap and water, DermaSyn Hydrogel, apply 4x4 gauze over the wound, apply Unna Boot with Calamine, Coban (self-adhesive wrap) apply over Unna Boot (compression wrap). Home care to complete Wednesday and Friday, wound care center on Mondays. There were no orders for the trochanter wound on these orders from the WCC. Orders with a 05/28/25 start date entered into the home care electronic medical records as follows: - wound to right lower extremity, wash with soap and water, pat dry, apply Hydrogel to wound bed, cover with gauze, apply Unna Boot toes to knee followed by coban every Wednesday and Friday and as needed for compromise, goes to wound care center Mondays. - left trochanter wound cleanse with soap and water, pat dry, apply hydrogel to wound bed and cover with foam dressing every Wednesday and Friday and as needed for compromise, goes to wound care center Mondays. On the 05/29/25 a registered nurse (RN) visited the patient for wound care and documented: - right lower extremity wound care completed – cleansed with antibacterial soap, patted dry, applied hydrogel to the wound bed then applied unna boot wrap toes to knee and covered with coban. - left trochanter wound cleansed with antibacterial soap, patted dry, applied hydrogel to the wound bed then covered with Allevyn. The order to apply hydrogel to the trochanter wound care order remained active throughout the rest of the home care episode without evidence an order was obtained to apply hydrogel to this wound. On 06/11/25, an RN visited the patient and documented that the trochanter wound was healed and Mepilex was applied per request of family. There is no evidence the nurse spoke with the physician office and obtained an order. On 07/17/25 at 2:30 p.m., the Registered Nurse Case Manager (RN) was interviewed about the wound care orders and treatments. The RN reported that if the orders entered into the home care electronic medical record did not match, the RN would have called the wound care center directly to clarify and this was done more than once and the RN documented this under patient activity. On 07/22/25 at 1:30 p.m., the record was reviewed with the Administrator, Director of Patient Services, and RN Team Manager. No further information was provided. Failure to administer treatments as ordered by the medical provider has the potential to place patient at risk for negative outcomes.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on clinical record reviews and staff interviews, the agency failed to ensure verbal orders are authenticated by the medical practitioner for 1 of 4 patients (patient #2). 1. Patient #2 was most recently admitted to the agency on 02/15/25 with diagnoses of right foot stage 3 pressure ulcer, scrotal/sacrum abrasion, quadriplegia, and neurogenic (nerve damage causing dysfunction) bowel and bladder. On 03/05/25 the patient was seen at the wound care center (WCC), who electronically sent wound care orders to the agency. The 02/15/25-04/15/25 Plan of Care, sent for signature to the patient’s primary care physician’s (PCP) office on 03/12/25, included wound care orders entered by the agency dated 03/07/25 which were not in accordance with what was ordered by the provider. (See 576 and 580 for order details). On 04/28/25 the WCC ordered: - Sacral/gluteal wound: apply white foam to wound bed then cover with black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC (no wound cleansing agent provided on order). On 04/30/25 the agency sent the following supplemental order to the WCC: - Sacral/gluteal wound: cleanse wound with Vashe (wound cleaning solution) wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin Seal (a skin barrier) to obtain seal if needed. Apply Aquacel Ag (absorptive dressing with silver) to superficial open areas on scrotum and surrounding peri-wounds. Place white foam in base of sacral wound followed by black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using Kerlix (a gauze wrap) and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. There was no evidence the supplemental order was signed off by the WCC specialist following the patient’s wounds. The order was subsequently sent to the patient’s PCP who signed the order on 05/20/25. On 05/05/25 the WCC ordered: - Sacral/gluteal wound: wound vac on hold. Cleanse wound with antibacterial soap and water. Apply a wet to dry dressing. Change daily for 1 week. On 05/07/25 the patient’s nurse documented in the patient’s activity notes they discussed with the WCC about restarting the wound vac per patient/caregiver request. The WCC agreed to this change. On 05/08/25 the agency created and sent the following supplemental order to the WCC: - Effective 05/07/25, cleanse scrotal wound with soap and water, pack with kerlix wet to dry with NS, and cover with a bordered foam dressing. Discontinuation date 05/08/25. - Effective 05/08/25, sacral/gluteal wound, cleanse wound with Vashe (wound cleaning solution) wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin Seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Place white foam in base of sacral wound followed by black foam. Attach wound vac to dressing at 150 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using Kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. There was no evidence the supplemental order was signed off by the WCC specialist following the patient’s wounds. The order was subsequently sent to the patient’s PCP who signed the order on 06/04/25. On 05/12/25 the WCC ordered: - Sacral/gluteal wound: cleanse wound with antibacterial soap and water. Apply 1 piece of black foam to wound bed. Attach wound vac to dressing at 125 mm/hg continuous pressure. Apply wet to dry dressing if wound vac fails. Wound care to be done 3x/week, twice by home care agency and once by WCC. On 05/13/25 the agency created and sent the following supplemental order to the WCC: - Sacral/gluteal wound: cleanse wound with Vashe wash soak for 5-10 minutes. May prep surrounding skin with stoma powder and skin prep. May use Eakin Seal to obtain seal if needed. Apply Aquacel Ag to superficial open areas on scrotum and surrounding peri-wounds. Place 1 piece of black foam dressing to wound. Attach wound vac to dressing at 125 mm/hg continuous pressure. If wound vac fails, apply wet to dry dressing using Kerlix and Vashe wash, apply skin prep to surrounding skin and cover with dressing. Wound care to be completed Monday, Wednesday, Friday, and as needed. May cancel on WCC days. There was no evidence the supplemental order was signed by the WCC following the patient’s wounds. The order was subsequently sent to the patient’s PCP who signed the order on 06/04/25 On 07/17/25, at 3:15 p.m., the surveyor interviewed the WCC regarding orders. The provider stated the orders given by the WCC are specific and reflective of what the WCC wants to be done for the wound care. If the order is not specific, the provider would expect the agency to call and get clarification. The provider also stated if a specific product was unavailable and/or if a product substitution wanted to be used, they would expect the agency to call. On 07/18/25, at 10:10 a.m., the surveyor interviewed the agency RN Team Manager regarding orders. The Team Manager stated when they received an order, they forward it to the patient’s nurse case manager, who then reviews and enters and/or updates the order. When asked what the process was if there was a question or clarification needed on an order, the Team Manager stated the nurse would call the provider for clarification and then document the exchange in the patient’s activity notes. The Team Manager was then asked what the process was if specific supplies ordered were unavailable. The Team Manager stated the nurse should call and obtain an interim order, then, if the supplies could not be obtained within a few days, the nurse would need to get a new order. On 07/18/25, at 11:15 a.m., the DPS was interviewed regarding orders received from the WCC. The DPS stated they became aware of an issue with the WCC when they were told the WCC would not sign some of the orders sent to them by the agency. A meeting then occurred between the agency and the WCC. The DPS further stated after looking into the problems reported regarding the orders, the agency staff became “lax” when documenting the details of verbal readbacks. The DPS also stated the Team Manager worked with the WCC to correct some of the orders that were sent but not signed. Failure to ensure orders are documented and authenticated by the ordering provider has the potential for incorrect care to be performed and negative patient outcomes.

This Statement of Deficiencies report is the result of a recertification survey conducted 01/29/25 – 01/31/25 and 02/03/25 – 02/05/25 The following information was reviewed on 01/28/25 during the pre-survey preparation: accuracy of contact information in the Health Commerce System. The following information was reviewed during the survey: the agency's emergency preparedness policies and procedures, the emergency patient roster, staff roster, and staff education. Interviews were conducted with the Director of Patient Services and Administrator. No deficiencies were cited.

The following Statement of Deficiencies represents the result of a partial extended recertification survey of Oswego Health Home Care, LLC conducted 01/29/25 – 01/31/25 and 02/03/25 – 02/05/25. A standard recertification survey was initiated on 01/29/25. Deficient practices were identified within Level 1 standards in 484.55 Condition of participation: Comprehensive assessment of patients, resulting in a partial extended survey. The survey consisted of a review of 18 clinical records including 7 observational home visits and 5 discharge records, 12 personnel records, 2 contracts, pertinent policies and procedures, Quality Improvement Meeting Minutes and Governing Body Minutes for the past 12 months, the agency's Admission Packet, Emergency Preparedness Plan, and On-call and Complaint Logs. At the time of survey the agency current census was 241. Pre-survey activities, on 01/28/25, consisted of review of the agency's Health Commerce System account, internet Quality Improvement Evaluation System Potentially Avoidable Event Reports for the period 11/01/23 – 10/31/24, and compliance with report submission for the 2023 statistical report. The Administrator, Director of Patient Services, Clinical Manager, Quality Improvement Coordinator, Human Resource Director, and nurse educator were interviewed. Findings were reviewed at the exit conference on 02/05/25. The following deficiencies were identified as a result of the survey: Federal Standard Level Deficiencies: G 0528 Health, psychosocial, functional, cognition, G 0536 A review of all current medications, G 0574 Plan of care must include the following, G 590 Promptly alert relevant physician of changes , G 0596 Revisions communicated to patient and MD, and G 0610 Patients receive education and training. State Deficiencies: J 1416, J1420, and J1460 Personnel.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on a review of clinical records and interviews with the Administrator and Director of Patient Services (DPS), it was determined in 2 out of 18 records, (patients #8 and 11) that comprehensive assessments were not of sufficient scope to ensure that all patient's needs were identified. Evidence as follows: Patient #8 was admitted to the agency on 11/25/24 with diagnoses of stage 3 pressure ulcer to the sacral region (tailbone), status post bowel resection with ileostomy, enterocolitis (inflammation of the intestines), severe protein-calorie malnutrition, and neurogenic bladder (bladder dysfunction). The 11/25/24-01/23/25 plan of care included the following ostomy orders: - Instruct patient on ostomy care. - Cleanse surrounding skin with warm water and soft cloth, rinse, and dry well. Apply no sting barrier wipe and if needed, stoma paste or cohesive seal to attain a secure seal. Apply wafer to skin around stoma and close bottom of bag. Use Coloplast One-Piece drainable pouch CT21007. Change every 4 days and PRN (as needed) leaking until stoma size stabilizes. Measure stoma at each appliance change and resize appliance accordingly to prevent leaking. Patient to perform ostomy appliance change when able to demonstrate independence. On 11/25/24 the registered nurse (RN) visited the patient for an initial visit and documented: - patient independent with ostomy care and changes the bag every 4 days - patient has good seal (of ostomy bag to skin) - unable to visualize stool due to bag There was no evidence the RN: - assessed/measured the stoma and/or discussed with the patient stoma size to determine if the stoma had stabilized and no longer needed to be measured with each appliance change - assessed the patient’s ability to perform ostomy care independently On 02/03/25 at 3:00 p.m. the record was reviewed with the Administrator and Director of Patient Services who acknowledged the findings and provided no additional information. Patient #11 was admitted to the agency on 11/04/23 with diagnoses that included management of vascular access device, hypomagnesemia, congestive heart failure, and legal blindness. The 12/28/24 plan of care included: - 7 routine oral medications ordered to be taken at least daily - 6 oral medications ordered to be taken as needed - order stating “patient takes meds out of bottles” On 11/04/23, a registered nurse (RN) visited the patient for a start of care visit and documented - the patient “administers medications from bottles” - the patient can read and write – “yes” - patient was legally blind - ability to see in adequate light – “severely impaired: no vision or sees only light, colors or shapes; eyes do not appear to follow objects” On 12/23/24, a registered nurse (RN) visited the patient for a recertification visit and documented the patient takes medications from the bottles daily and patient is legally blind. On 02/03/25 at 3 p.m., the record was reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. On 02/04/25 at 4 p.m., the surveyor interviewed the RN that conducted the 12/23/24 recertification visit and asked how the visually impaired patient was able to manage the oral medications. The RN reported that the patient had a system in which the medications are lined up in a specific order and using this method, the patient was able to identify the correct medication and could report when to take it. The RN was unsure who assisted the patient with setting up the medications if a medication was refilled or if there was a change in the prescriptions but stated it could be the patient’s aide. The surveyor asked who was providing the aide service as there was no mention of aide service in the recertification visit or the plan of care. The RN reported that they believe the patient had an aide provided by the insurance company. On 02/05/25 at 8:30 a.m., the surveyor interviewed the Director of Patient Services who reported the regular case manager had resigned, and they were unable to find any documentation in the medical record regarding how the oral medications were managed. The Director could not confirm if an aide was involved in the patient’s care but did report a caregiver assists with other tasks but was unsure if they assist with oral medication management. The agency failed to assess how a legally blind patient managed oral medications. Patient #15 was admitted to the agency on 05/22/24 with diagnoses malignant neoplasm of the esophagus, sepsis, aspiration pneumonitis, and chronic obstructive pulmonary disease. This patient was selected from the internet Quality Improvement and Evaluation System (iQIES) potentially avoidable events report dated 11/01/23 through 10/31/24 for substantial decline in 3 or more activities of daily living. The 05/22/24 plan of care included: -Skilled nursing 2 times a week -Physical therapy evaluation and treat -Occupational therapy evaluation and treat -Nutritional evaluation and treat -Aide services 2 times a week The patient required a urinary Foley catheter, gastric tube for all nutritional intake, and oxygen 2 liters as needed for shortness of breath. On 05/27/24 the patient had been readmitted to the hospital due to the gastric feeding tube became dislodged, a new feeding tube had been placed and was discharged home on 06/21/24. On 06/21/24 the nurse conducted a resumption of care visit, that included patient was dependent with all aspects of activities of daily living, and patient’s spouse was able to provide care. On 06/21/24 the resumption of care orders included: -Skilled nursing 2 times a week -Physical therapy evaluate and treat -Occupational therapy evaluate and treat The patient had continued needs for a urinary Foley catheter, gastric to tube for all nutritional intake, and oxygen 2 liters as needed for shortness of breath. The 06/21/24 resumption of care assessment included needing assistance for all activities of daily living. On 07/03/24 the occupational therapy conducted an initial visit (12 days after returning home from the hospital), documented patient had been dependent on all activities of daily living and needing assistance of 2 people for bathing and dressing. The patient was scheduled to be evaluated by hospice on 07/05/24. On 02/3/25 at 1 p.m., the surveyor interviewed the Director of Patient Services (DPS) about how aide services are ordered and the process of obtaining services through the agency contract for services. The DPS stated they have an intake nurse review the nursing assessments and when an aide has been ordered, they contact the agency that provides the aide services to our agency, then a start date is determined for aide services. That process had started on the 05/22/24 start of care assessment. The surveyor asked why the aide and nutritional services had not been included on the resumption of care orders with documentation to support the need in the home. The DPS stated the patient was rallying and thought the aide services may not be needed. However, there was no supporting documentation in the record to reflect that status. The DPS provided additional documentation with a narrative noted form the resumption of care dated 06/21/24, that included "Pt required assistance with actives of daily living, which wife is assisting him with at this time No mention from wife on HHA(home health aide) services though noted in the start of care noted. Patient has activities of daily deficits and will benefit form a Occupational Therapy evaluation." The nurse failed to evaluate the need for aide services with continued increased weakness and nutritional services, since the gastric tube feeding remained place with nothing by mouth status, at the resumption of care assessment. Failure of the agency staff to perform a comprehensive assessment of the patients may result in unmet patient needs and negative outcomes.

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 a review of clinical records, observational home visits, and interviews with the Administrator, Director of Patient Services, and patients, it was determined in 2 of 18 records (patients #2 and 6) the skilled nurse failed to perform comprehensive medication reviews. Evidence as follows: 3. Patient #5 was admitted to the agency on 01/24/25 with diagnoses of staph bacteremia (infection in the blood), hypertensive heart disease, history of B-cell lymphoma, and depression. The 01/24/25-03/24/25 Plan of Care (POC) included citalopram 20mg daily. On 01/24/25 the registered nurse (RN) visited the patient for an initial visit and documented: - medication list reviewed with patient and patient caregiver - Zofran and hydrocodone discontinued - medication profile updated On 01/31/25 at 10:00 a.m. the surveyor conducted an observational home visit with the RN. The RN discussed the following medication changes with the patient and patient caregiver: - discontinuation of active blood pressure medications per physicians order - discontinuation of prednisone taper and starting of dexamethasone per physicians order - discontinuation of Abreva because patient was not using and did not have in the home After the RN left, the medication profile and medication bottles were reviewed with the patient and patient caregiver. The surveyor noted the patient was not taking the citalopram and there was no medication bottle for it in the home. The RN failed to perform a complete and accurate medication reconciliation with the patient. On 02/03/25 at 10:30 a.m. the record was reviewed with the Administrator and Director of Patient Services who acknowledged the findings and provided no additional information. Failure to perform complete and accurate medication reviews could lead to patients potentially taking medications inconsistent with the physician's intentions and possible negative patient outcomes. Home visit 1. Patient #6 was admitted to the agency on 12/19/24 with diagnoses that included stage 4 pressure ulcer to the sacrum, right heel deep tissue injury, and dementia. On 01/30/25, the surveyor printed the most recent updated copy of the medication profile and 12/30/24 plan of care from the electronic record. These documents included the following orders: - ProMod Protein oral liquid 30 mL to be administered orally 4 times per day - Ensure plus 3 times a day with ProMod 4 times a day On 01/31/25, the surveyor conducted an observational home visit with the nurse present. During the visit, the nurse asked the caregiver if there were any medication changes, which the caregiver denied. Following the nurse visit, the surveyor interviewed the caregiver regarding the medications the patient was taking. The following discrepancy were identified: - ProMod Protein oral liquid was not included on the caregiver’s medication list. The surveyor asked to see this medication and the caregiver did not know what it was. The caregiver showed the surveyor a bottle of Ensure and reported that was the only protein supplement patient was receiving. On 02/03/25 at 12 p.m., the surveyor interviewed the RN that conducted the visit on 01/31/25. The nurse reported that when they asked about the ProMod Protein oral liquid, the caregiver also showed the RN a bottle of Ensure. The nurse failed to perform to reconcile the use of the ProMod Protein when it was identified that this was not being administered by the caregiver. On 02/03/25 at 3 p.m., the record was reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. Home visit 2. Patient #2 was admitted to the agency on 01/16/25 with diagnoses that included dementia, chronic embolism left lower extremity, hypertension, dysphagia, and stage 2 pressure ulcers of right and left buttocks. On 01/30/25, the surveyor printed a copy of the patient’s most recent medication list, which included: - famotidine 20 mg tablet daily with instructions “do not skip doses or discontinue unless directed by your doctor” On 01/30/25, the surveyor conducted a home visit with an occupational therapist present. Following the visit, the surveyor interviewed the caregiver about the medications the patient was taking. The following discrepancies were identified: - famotidine - caregiver was unable to locate this mediation in the home and reported they thought it had not been administered recently due it was a pill and patient was unable to swallow pills. The following medications reported by the caregiver as current and were not included in the plan of care or medication profile: - biotin – caregiver reported patient takes this once daily - senna – caregiver showed surveyor a bottle of liquid senna and reported the patient does not take this often but occasionally needs - preparation H – caregiver reported this was applied to rectal area multiple times a day due to history of hemorrhoids The nurse failed to perform a comprehensive medication reconciliation. On 02/03/25 at 10:30 a.m., the record was reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. Failure to perform complete and accurate medication reviews could lead to patients potentially taking medications inconsistent with the physician's intentions and possible negative patient outcomes.

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 a review of clinical records, and interviews with the Administrator and Director of Patient Services, it was determined in 3 of 18 records (patients #1, 3, and 10) the agency failed to develop complete and accurate plans of care that were individualized to address the total needs of the patients. Evidence as follows: Home visit 1. Patient #6 was admitted to the agency on 12/19/24 with diagnoses that included stage 4 pressure ulcer to the sacrum, right heel deep tissue injury, and dementia. The 12/20/24 plan of care included the order for skilled nurse to instruct patient/caregiver to keep right heel deep tissue injury clean, dry, and open to air. Keep heel elevated and off the bed at all times. On 01/31/25, the surveyor conducted a home visit with a registered nurse (RN). During the visit, the surveyor observed the patient was wearing thin, white socks that were semi-transparent on both feet and a dressing was visible on the right heel. The nurse did not remove the socks or assess the heel wound during the visit. Following the visit, the surveyor interviewed the caregiver who reported they were told it is best to keep the heel covered so they keep a bandage on it. The caregiver could not recall who gave that instruction. The caregiver attempted to show the dressing to the surveyor, however, the patient winced slightly when the caregiver attempted to remove the sock. The surveyor told the caregiver it was not necessary to remove the socks at this time. The surveyor also observed that the heels were flat on the bed and were not elevated. On 02/03/25 at 9:30 a.m., the surveyor reviewed the RN documentation for the 01/31/25 visit, which stated: - wound #3 assessed this visit “yes” - wound 3 description – “deep tissue injury on heel of right foot” - wound 3 exudate amount today – “none” - wound 3 wound bed condition today – “dry” - wound 3 wound bed periwound today – “WNL” - wound 3 status – “no change” - wound 3 treatment – “open to air” On 02/03/25 at 12 p.m., the surveyor interviewed the nurse who confirmed the heel wound was not assessed during the visit but reported the documentation for wound #3 must have “carried over.” The RN reported that they assessed the wound on the previous visit on 01/27/25 and there was no dressing at that time. The RN edited the documentation to reflect that the heel wound was not assessed on the 01/31/25 visit. On 02/03/25 at 3 p.m., the record was reviewed with the Director of Patient Services and Administrator, they acknowledged the findings. The Director of Patient Services reported that sometimes documentation does “carry over,” however, the clinician usually has to edit the documentation in some way for this to happen. The agency failed to obtain an order for the dressing change to the heel wound. 2. Patient #2 was admitted to the agency on 01/16/25 with diagnoses that included dementia, chronic embolism left lower extremity, hypertension, dysphagia, and stage 2 pressure ulcers of right and left buttocks. The 01/16/24 plan of care DME and Supplies included “wound care supplies” and failed to include a hospital bed. The agency failed to include all DME supplies on the plan of care. Home Visit Patient #3 was admitted to the agency on 01/06/25 with diagnoses of pleural effusion with pleurx drain, breast cancer, lung cancer, chronic obstructive pulmonary disease (COPD), chronic kidney disease, post mastectomy lymphedema and dependence on supplemental oxygen. Bathing The 01/06/25-03/06/25 Plan of Care (POC) included the following orders: - Right side pleurx catheter, drain 3 times per week(M/W/F) and PRN (as needed) for shortness of breath or discomfort. Call MD for drainage less than 100cc for 2 consecutive drains. Do not drain more than 1000cc at one time. Change dressing with each draining and PRN for soiling/problems. Cleanse catheter site with alcohol swab, cover with foam sponge, dry 4x4, and transparent dressing using sterile technique. On 01/31/25 the Registered Nurse (RN) updated the POC to include the following wound care orders: - Right elbow skin tear: Cleanse wound with soap and water, pat dry, apply triple antibiotic ointment to open areas, cover with nonstick dressing, 4x4 and kerlix. To be changed 3 times a week (M/W/F) and PRN soiling. On 01/31/25 at 9:00 a.m. the surveyor completed an observational home visit with the RN. The surveyor interviewed the patient after the RN left and asked how they were bathing. The patient reported that they had been sponge bathing due to the pleurex drain. The RN failed to include bathing instructions for the patient to follow. Lymphedema The referral dated 01/03/25 listed a compression sleeve to be applied to left arm for post mastectomy lymphedema. There was no evidence in the record addressing the use of a lymphedema sleeve. Following the observational home visit on 01/31/25 at 9:00 a.m., the surveyor interviewed the patient and asked if they were using the lymphedema sleeve listed on the referral. The patient reported that she does put it on during the day when able. The RN failed to include orders for lymphedema sleeve application in the plan of care. Durable Medical Equipment (DME) The 11/25/24 POC included order for pleurx drain 3 times per week. The 11/25/24 POC failed to include in the DME and Supplies section: lymphedema compression sleeve. On 02/03/25 at 10:30 a.m., the records were reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. Home Visit Patient #4 was admitted to the agency on 01/21/25 with diagnoses of chronic ulcer of right foot, type 2 diabetes, neuropathy, hypertension, coronary artery disease and chronic pain. Medication The Surveyor reviewed the most current Plan of Care (POC) dated 01/21/25 prior to the next day observational home visit. On 01/31/25 at 9:00 a.m. the surveyor completed an observational home visit with the RN. The surveyor interviewed the patient after the RN left and asked how they managed their medication. The patient reported that their spouse pre-pours the medication and that they take is from the medbar. The RN failed to include order for medication management in the patient's POC. The POC Durable Medical Equipment (DME) and supplies included the following: -Patient/caregiver to test blood glucose 1 time a day in AM, pre-prandial and PRN for signs and symptoms of hypo or hyperglycemia; call MD is 300. -Patient to wear cam boot all the time except for hygiene care and sleeping. The DME and Supplies section failed to include glucometer and cam boot. On 02/03/25 at 10:30 a.m., the records were reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. Patient # 10 was admitted to the agency on 02/24/24 for attention to other artificial openings of urinary tract (nephrostomy), hydronephrosis, type 2 diabetes, chronic kidney disease, depression, chronic pain, and Factor V Leiden. The patient was hospitalized from 01/09/25 – 01/14/25 for acute cystitis. The resumption of care visit was conducted on 01/16/25 and included the following orders: Nephrostomy Care and Bathing - skilled nurse to cleanse nephrostomy tube site with normal saline and gauze; apply stayfix dressing and cover with gauze and then Tegaderm. Change once a week on Thursdays and PRN drainage/dressing compromise. The referral dated 01/14/25, listed bilateral nephrostomy sites. The RN documented in the wound grid that the patient had bilateral nephrostomy tubes. The plan of care post hospitalization failed to identify that the patient had bilateral nephrostomy tubes. The RN failed to include bathing instructions for the patient to follow. Durable Medical Equipment (DME) The 12/24/24 – 02/21/25 Plan of Care (POC) included the following orders: - SN to cleanse nephrostomy tube site with NS and gauze; apply stayfix dressing and cover with gauze and then Tegaderm. Change once a week on Thursdays and PRN drainage/dressing compromise. POC failed to include nephrostomy supplies in the DME and Supplies section. On 02/03/25 at 3:00 p.m., the records were reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. Patient #8 was admitted to the agency on 11/25/24 with diagnoses of stage 3 pressure ulcer to the sacral region (tailbone), status post bowel resection with ileostomy, enterocolitis (inflammation of the intestines), severe protein-calorie malnutrition, and neurogenic bladder (bladder dysfunction). Wound Care The 11/25/24 plan of care included the following wound care orders: - Wound care to stage 2 pressure ulcer M-W-F and as needed (PRN) soiling or dressing compromise. Clean with normal saline or soap and water, pat dry, apply aquacell ag to wound bed, apply skin prep to surrounding skin, apply magic butt paste to excoriated areas, and cover with meplilex border. Shower on days of wound care, remove dressing prior, nurse to reapply. On 12/10/24 the Registered Nurse (RN) updated the plan of care to include the following wound care orders: - coccyx wound: Cleanse wound with antibacterial soap and water and pat dry. Using 1 piece of calcium alginate, cut small tail and gently pack into tunnel at 12 o’clock, place remainder over wound bed, and cover with allevyn sacral with border. Dressing to be change by wound care clinic 1 X/week and agency 2 X/week and as needed dressing if comprise. On 12/10/24 the RN failed to include in the plan of care what days wound care was to be provided and bathing instructions for the patient to follow. Durable Medical Equipment (DME) and supplies The 11/25/24 plan of care included the following orders: - TPN (total parental nutrition) infusion daily - PICC (peripherally inserted central catheter) dressing change every 7 days and PRN - ostomy care/appliance change every 4 days and PRN - straight catheterization 3 times/day and PRN The DME and Supplies section: failed to include the following: - infusion supplies - PICC dressing change supplies - ostomy care supplies - straight catheterization supplies On 02/03/25 at 3:00 p.m. the record was reviewed with the Administrator and Director of Patient Services who acknowledged the findings and provided no additional information. Patient #1 was admitted to the agency on 03/02/23 with diagnoses of diabetes type 2, schizophrenia, borderline personality disorder, and legal blindness. On 10/17/24 the registered nurse (RN) saw the patient for a recertification visit and documented in the “Safety” section the patient was “able to call for help with life alert system in place.” The 10/22/24-12/20/24 Plan of Care (POC) failed to include an order for the use of a life alert system or list the life alert system in the DME and Supplies section. The 10/22/24-12/20/24 POC included an order for a CPAP (continuous positive airway pressure) at bedtime. The POC failed to include in the DME and Supplies section: CPAP machine and supplies. The 12/21/24-02/18/25 POC included the following order: - activity as tolerated, blind cane or human supervision when outside the home The POC failed to include in the DME and Supplies section: blind cane and life alert system. On 02/03/25 at 3:00 10:00 a.m. the record was reviewed with the Administrator and Director of Patient Services who acknowledged the findings and provided no additional information. Failure to ensure the development of complete and accurate plans of care to meet the needs of the patients has the potential for negative outcomes for the agency's patient population. Patient #12 was admitted 08/08/24 with diagnoses of encounter for change or removal of drains (has a biliary drain in place), cholecystitis, type 2 diabetes mellitus, cirrhosis of the liver. The 12/06/24 plan of care included orders for caregiver /nurse to perform care on upper right quadrant biliary drain. Clean drain site with normal saline, then apply stayfix, cover with gauze and apply Tegaderm. Flush biliary drain twice daily with 10ml of sterile saline. The 12/06/24 (Durable Medical Equipment) DME and supplies on the plan of care included: Shower chair, bedside commode, walker, wheelchair, glucometer, thermometer and tape measure. The DME and supplies failed to include: Biliary drain supplies, 10ml of sterile saline, stayfix, gauze, and Tegaderm. The agency failed to include all DME supplies on the plan of care. Patient #9 was admitted to the agency on 01/09/23 with diagnoses of hypertensive heart, chronic kidney disease, chronic diastolic heart failure and pleural effusion. The 12/29/24 plan of care included: Left side pleurx catheter drain to be drained once a week and as needed for shortness of breath. Change dressing with each draining and as needed. Cleanse catheter site with alcohol swab, cover with foam sponge, cover with gauze and transparent dressing using sterile technique. The 12/29/24 plan of care DME and supplies included: Inhaler, thermometer, tape measure and scale. The DME and supplies failed to include pleurx catheter drainage tubes the fluid is drained to, pleurx dressing supplies. The agency failed to include all DME supplies on the plan of care. Home visit Patient #7 was admitted to the agency on 01/01/25 with diagnoses of spondylolisthesis of the lumbar region, type 2 diabetes mellitus, hypertension, and abdominal aortic aneurysm. The 01/01/25 plan of care included: -Skilled nurse to removal of Peripherally Inserted Central Catheter (PICC) 1/03/25. -Skilled nurse to instruct patient to test blood glucose 2 times a day and as needed. -Skilled nurse to change wound Vacuum Assisted Closure (VAC) dressing 3 times a week and instruct patient on back up wound dressing of normal saline wet to dry daily. The 01/01/25 plan of care DME supplies listed was – “none”. The DME supplies failed to include: -Diabetic equipment used in the home. -Infusion supplies that patient had on start of care. -Wound care supplies needed for a VAC application and back up supplies. The agency failed to include all DME supplies on the plan of care. On 02/03/25 at 10:30 a.m., the records were reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information.

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 a review of clinical records, and interviews with the Director of Patient Services (DPS) and Clinical Administrator it was determined for 1 out of 18 patients (patient #10) the nurse failed to consult with the physician when changes in the patient's condition occurred. Evidence as follows: 1.Patient #10 was admitted to the agency on 02/24/24 with diagnoses of attention to other artificial openings of urinary tract (nephrostomy), hydronephrosis, type 2 diabetes, chronic kidney disease, depression, chronic pain, and Factor V Leiden. The patient was hospitalized from 01/09/25 - 01/14/25 for acute cystitis. The resumption Of care (ROC) visit was conducted on 01/16/25 and included the following orders: - nurse to cleanse nephrostomy tube site with NS and gauze; apply stayfix dressing, cover with gauze and then tegaderm. Change once a week on Thursdays and PRN drainage/dressing compromise. At the ROC visit on 01/16/25 the nurse documented: -Wound narrative: Patient’s back was breaking out in a rash from being in the hospital. Patients back cleansed to remove betadine. -Synopsis: rash would “require close monitoring”. On 01/23/25, at the next nursing visit, the nurse documented: -Wound narrative: Cleansed nephrostomy tube site with NS (normal saline) and patted dry with gauze. Applied gauze to site and then secured with tape. -Synopsis: Patient's back was excoriated with a weeping rash, only used gauze over sites today for the rash to dry out. On 01/27/25 the patient had a nursing visit to assess bilateral nephrostomy tube dressings, the nurse documented: -Wound narrative: Cleansed nephrostomy tube site with NS (normal saline) and patted dry with gauze. Applied gauze to site and then secured with tape. -Synopsis: Patient's back remains excoriated with a semi weeping rash in areas and dried in others. Patient is now broken out in a very itchy rash on their chest, abdomen and upper arms. Will make physician aware. -Activity log: Call placed to physician on 01/27/25 to notify of new rash to patient's chest, abdomen and upper arms. Physician office instructed patient to go to urgent care for evaluation of new rash. On 01/30/25 the nurse visited the patient and documented: -Wound narrative: Cleansed nephrostomy tube site with NS (normal saline) and patted dry with gauze. Applied gauze to site and then secured with tape. Patient's back remains with a dried out rash to back and continues to refuse the stayfix at visit. -Synopsis: Patient's back is excoriated with a semi weeping rash. Patient did not go to urgent care for evaluation of new rash. Rash to chest, abdomen and upper arms better with the use of betamethasone cream that was already in the home. There was no evidence the nurse notified the physician the patient did not go to urgent care as instructed, was using betamethasone cream to treat rash, had excoriated/weeping area on their back, and the use of alternative products to secure nephrostomy tubes. On 02/03/25 at 3:00 p.m., the records were reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information.

Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) 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 or allowed practitioner's issuing orders for the HHA plan of care. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with the Director of Patient Services and Administrator, it was determined 1 of 18 records (patient #15) the agency failed to explain changes in the plan of care to the patient/caregiver. 1.Patient #15 was admitted to the agency on 05/22/24 with diagnoses of malignant neoplasm of the esophagus, sepsis, aspiration pneumonitis, and chronic obstructive pulmonary disease. This patient was selected from the internet Quality Improvement and Evaluation System (iQIES) potentially avoidable events report dated 11/01/23 through 10/31/24 for substantial decline in 3 or more activities of daily living. The 05/22/24 plan of care included: - skilled nursing 2 times a week - physical therapy evaluation and treat - occupational therapy evaluation and treat - nutritional evaluation and treat - aide services 2 times a week The patient required a urinary Foley catheter, gastric tube for all nutritional intake, and oxygen 2 liters as needed for shortness of breath. On 05/27/24 the patient was readmitted to the hospital due to the gastric feeding tube becoming dislodged. A new feeding tube was placed, and the patient was discharged home on 06/21/24. On 06/21/24 the nurse conducted a resumption of care visit and documented: the patient required assistance with activities of daily living, which spouse was assisting with. No mention from [spouse] on HHA (home health aide) services though noted in the start of care. Patient has activities of daily deficits and will benefit from a Occupational Therapy evaluation. On 06/21/24 the resumption of care orders included: - skilled nursing 2 times a week - physical therapy evaluate and treat - occupational therapy evaluate and treat The patient had continued needs for a urinary Foley catheter, gastric tube for all nutritional intake, and oxygen 2 liters as needed for shortness of breath. On 07/03/24 the occupational therapist conducted an initial visit and documented the patient was dependent on all activities of daily living and needed assistance of 2 people for bathing and dressing. The patient was scheduled to be evaluated by hospice on 07/05/24. On 02/03/25 at 1 p.m., the surveyor interviewed the Director of Patient Services (DPS) about how aide services are ordered and the process of obtaining services through the agency contract for services. The DPS stated they have an intake nurse review the nursing assessments and when an aide has been ordered, they contact the agency that provides the aide services via contract, then a start date is determined for aide services. That process had started for this patient on the 05/22/24 start of care assessment. The surveyor asked why the aide and nutritional services had not been included on the resumption of care orders as documentation supported their continued need. The DPS stated they thought the patient was rallying and aide services may not have been needed. However, there was no supporting documentation in the record to reflect that status. There was no evidence the nurse informed the patient and caregiver of the changes to the plan of care that included elimination of home health aide and nutritional services, or that patient and or caregiver agreed to those changes. On 02/03/25 at 10 a.m., the record was reviewed with the Administrator and Director of Patient Services who acknowledged the findings and provided no additional information. Failure to explain changes in the plan of care to the patient and or caregiver may result in unmet needs and negative patient outcomes.

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 clinical records and interviews with the Director of Patient Services (DPS) and Administrator, it was determined in 1 of the 18 records (patient #6) the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Home visit Patient #6 was admitted to the agency on 12/19/24 with diagnoses that included stage 4 pressure ulcer to the sacrum, right heel deep tissue injury, and dementia. The 12/20/24 plan of care included the following orders: - nurse visit frequency of 2w1, 3 week 6, and 6 PRN [as needed] - Skilled nurse to perform wound care to stage 4 pressure ulcer of sacrum Monday, Wednesday, and Friday and as needed for soiling, loss of integrity. Cleanse wound with normal saline, apply hydrofera blue moistened with normal saline into wound bed, cover with 4x4’s, secure with mepilex border. Instruct caregiver to call agency if becomes wet, soiled, loss of integrity or any symptoms of infection. OK to use aquacel covered with foam or dry dressing until ordered supplies arrive at home. - Skilled nurse to instruct patient/caregiver to keep right heel deep tissue injury clean, dry, and open to air. Keep heel elevated and off the bed at all times. Call skilled nurse if area opens. Call MD for signs/symptoms of infection, temperature 100.4, increased pain, problems with dressing. The week of 01/26/25, nurse visits were made on Monday 01/27/25 and Friday 01/31/25. There was no documentation why only 2 visits were scheduled for the week. On 01/31/25, the surveyor conducted an observational home visit with the nurse present. During the visit, the nurse asked the patient if there were any changes made at the wound care center appointment on Wednesday 01/29/25. The caregiver reported that the appointment was canceled due to inclement weather. The nurse did not ask the caregiver if the dressing had been changed or instruct the caregiver to contact the office to request a nurse visit for dressing change in the event of a canceled visit in the future. Following the nursing visit, the surveyor interviewed the caregiver who reported that they perform the sacral dressing change when the patient has a canceled appointment at the wound care center or if the patient is incontinent of stool and soils the dressing. On 02/03/25 at 12 p.m., the surveyor interviewed the nurse who was the case manager and visited the patient on 01/31/25. They reported that they were not aware the caregiver was performing wound care and did not believe the caregiver was ever taught or demonstrated wound care to agency staff. The nurse also reported the caregiver did perform wound care prior to receiving home care services and questioned if the caregiver was confused when speaking to the surveyor about when they performed wound care. The caregiver did not appear to be confused during the nursing visit and indicated they were performing dressing changes currently as needed between nursing visits. The agency failed to instruct the caregiver on how to perform dressing changes. On 02/03/25 at 10:30 a.m., the records were reviewed with the Director of Patient Services and Administrator, they acknowledged the findings and provided no additional information. Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in a negative patient outcome.

This Statement of Deficiencies report is the result of a recertification survey conducted 02/23/22 - 03/04/22. The following information was reviewed on 02/22/22 during the pre-survey preparation: Participation in the required emergency drills, and accuracy of contact information in the Health Commerce System. The following information was reviewed during the survey: the agency's emergency preparedness policies and procedures, the emergency patient roster and current listing of agency staff. Interviews were conducted with the Administrator, Director of Patient Services and Nursing Manager. No deficiencies are being cited.

The following statement of deficiencies represents the results of a partial extended re-certification survey of Oswego Health Home Care, Certified Home Health Agency conducted on 02/23/22 through 03/04/22. A standard re-certification survey was initiated on 02/23/22. Deficient practices were identified within Level 1 standards in 484.60 Care Planning, Coordination, and 484.8 Home Health Aide Service resulting in a partial extended survey. The survey consisted of a review of 17 clinical records including 5 discharge records, 7 observational home visits and 12 personnel records for professional and paraprofessional personnel. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past 12 months, the agency's Admission Packet, the Emergency Preparedness Plan, complaint, and on-call logs. Pre-survey activities consisted of review on 02/22/22 of the agency's Health Commerce System account, Home Care Worker Registry, Criminal History Record Check, Certification and Survey Provider Enhanced Reports (CASPER) for the period 12/01/2020 - 10/29/21, and the agency's compliance with report submissions for the 2021 statistical report and the Emergency Drill conducted 06/11/2019 through 06/13/2019. The Administrator, Director of Patient Services, Nursing Manager, Quality Improvement Nurse, and staff were interviewed throughout the survey. Findings were reviewed with the Administrator, Director of Patient Services, Nursing Manager, Quality Improvement Nurse at the exit conference on 03/04/22. Covid-19 mandated vaccination status was reviewed. The following deficiencies are identified as a result of the survey: Federal: G 526 Content of the Comprehensive Assessment; G 536 A review of all Medications; G 572 Plan of care; G 606 Integrate All Services; G 682 Infection Prevention; G 687 Vaccination of HHA staff and G 798 Home Health Aide Assignment and Duties State: J 1426 Personnel

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on a review of clinical records, policies and procedures, and interviews with the Director of Patient Services (DPS), and Nursing Manager, it was determined in 1 of 17 records (Patients #7) the agency failed to ensure comprehensive assessments were of sufficient scope to identify all patient needs. Evidence as follows: 1. Patient #7 was admitted to the agency on 02/13/22 with a primary diagnosis of surgical amputation of the left great toe and secondary diagnoses of type 2 diabetes, osteomyelitis of the left foot, depression, anxiety, and hyperlipidemia. On 02/13/22 the Registered Nurse (RN) visited to perform a comprehensive assessment. The RN documented fasting glucose of 250 that morning but failed to determine how many units of insulin were taken and if the patient was proficient in using the sliding scale. The RN documented "she (the patient) gave me a sliding scale, I will confirm with the PCP (primary care physician) as I am unsure if she is even taking. I do question compliance because when I reviewed the short-acting insulin and sliding scale, the patient seemed evasive and the husband asked her why she didn't do it like that." There was no indication where the patient had obtained the sliding scale, or if it was written down or on the patient's phone. On 02/14/22, the RN called the physician to obtain the patient's sliding scale. The office personnel could not locate an ordered sliding scale and called back to inform the RN an ordered sliding scale could not be found; the RN relayed the scale the patient had given (200 - 250 > 20u, 251 - 300 > 24u, 301 - 350 > 26u, 351 - 400 > 28u) to the office personnel who then stated that scale was "OK". On 02/14/22 the RN visited and documented "patient covers sliding scale as prescribed" but did not indicate what the glucose reading was or how many units were taken. On 02/15/22 the licensed practical nurse (LPN) visited and documented the glucose levels ranged between 165 and 213 since the last visit and the morning glucose was 213. The LPN failed to document if the patient had correctly utilized the sliding scale or how many units were taken for the 213 reading. On 02/17/22 the RN visited and documented the glucose levels ranged between 144 - 240 since the last visit, the patient can teach back the sliding scale, but failed to document the morning fasting blood glucose. On 02/21/22, the RN visited and documented glucose readings between 108 and 235 since the last visit, the patient can teach back the sliding scale. The RN failed to document the morning fasting blood glucose. On 02/23/22 the LPN visited and identified the range of 135 - 223 since the last visit. The LPN failed to document the morning fasting blood glucose. On 02/27/22 the LPN visited and the readings were 140 - 198 since the last visit with fasting glucose of 244. The patient can correctly teach back the sliding scale. The LPN did not indicate how many units the patient had taken for the elevated reading of 244 to identify patient competency with the sliding scale. On 02/28/22, the surveyor conducted an observational home visit with the registered nurse (RN) to perform a peripherally inserted central catheter dressing change and medication reconciliation. The following insulin sliding scale discrepancy was identified: The RN asked the patient what the morning fingerstick glucose was (240) and how much insulin coverage she had taken? (18 units). The RN asked why only 18u and asked to see the patient's sliding scale. The patient responded that she did not have the sliding scale written down, that it was on her phone. The RN asked her where she got the sliding scale on her phone because it did not match the sliding scale from the physician. The patient said, "from the internet". The RN indicated that 20 units should have been taken for a reading of 240, not 18, and the patient agreed to take an additional 2 units. A review of the Agency's Policy titled Diabetes Mellitus Standard of Care, revised 08/2021 included "The nurse will assess patient knowledge/skill deficits in the following areas and instruct as needed: observation of preparation and administration of injectable medications as ordered until independence has been demonstrated (e.g. long-acting, short-acting and/or sliding scale insulins). After the visit, the Surveyor interviewed the patient. The patient stated the nurses asked her about it at every visit and then admitted that she didn't have a copy of the sliding scale or anything that was written down and was "lackadaisical" when answering about the sliding scale and avoided talking about it. The RNs and LPNs failed to ensure the patient had an accurate copy of the physician-ordered sliding scale and knew how many units to take each time the blood glucose was tested and failed to follow the Agency's policy to observe and instruct sliding scale insulin until independence is demonstrated. After the initial note on 02/13/22 that questioned compliance and comprehension, the RNs and LPNs failed to follow up to ensure the patient had the correct sliding scale ordered by the physician. and was using it correctly. On 03/01/22 at 1:30 pm, the surveyor reviewed the record with the Administrator, DPS, Nursing Manager, and Quality Nurse. They acknowledged the findings and provided no additional information. Failure to ensure comprehensive assessments are complete and accurately the patient's status can result in negative patient outcomes.

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 a review of clinical records and interviews with the Administrator, Director of Patient Services (DPS), Nursing Manager, and clinical staff it was determined in 3 of 17 records (patients # 3, 7, and 12) the registered nurse (RN) failed to perform comprehensive medication reviews. Evidence as follows: HV Patient # 3 was admitted to the agency on 07/19/21 with diagnoses of type 2 diabetes with chronic foot ulcer, Charcot’s joint left ankle and foot, osteomyelitis, and hypertension. On 01/11/22 the registered nurse (RN) visited the patient for a recertification assessment. The RN documented all medications were reviewed and medications in home matched the agency medication list. No discrepancies were found. The 01/15/22 Plan of Care included the following medications, all with a start date of 10/12/21: - metronidazole (antibiotic) 500 mg twice daily for 30 days - florastor (probiotic) 250 mg twice daily for 30 days - magnesium (supplement) 400 mg daily On 02/24/22 the surveyor completed an observational home visit with the RN. During the visit the RN reviewed the patient’s current medications. The patient stated he was no longer taking metronidazole, florastor or magnesium, and had completed those medications in November (2021). The RN stated that she would contact the physician to confirm discontinuation and update the medication profile. From the time the above listed medications were completed on or around 11/11/21, through the observational home visit on 02/24/22, the RN failed to complete a comprehensive assessment of all patient medications. On 03/01/22 at 1:30 PM, the record was reviewed with Administrator, DPS, Nursing Manager and Quality Nurse. No additional relevant information was provided. 1. Patient # 12 was admitted to the agency on 02/15/22 with a primary diagnosis of urinary tract infection and secondary diagnoses of surgical aftercare of abdominal wound, liver transplant, COPD, chronic kidney disease, hypertension, orthostatic hypotension, PTSD, anxiety, major depressive disorder, and atrial fibrillation. The Registered Nurse failed to ensure the medication list was accurate and updated with changes. On 02/15/22, the RN attempted to reconcile the medications and obtained a printed MAR (medication administration record) from the assisted living facility staff to compare with the hospital discharged medication list. Several discrepancies were noted. The RN phoned the physician's office and developed a plan with the office staff to fax the MAR to the MD office for review and documented "a med rec. will need to be done". - On 02/18/22, the RN visited and documented "ALF (assisted living facility) staff manages all medications. Lactulose not yet in " regarding medications and did not indicate if the medication reconciliation had been completed. - On 02/21/22, the RN visited and documented "ALF (assisted living facility) staff manages all medications. Lactulose, not yet in. Med list reviewed, no med changes or problems identified. Medication reconciliation performed, "Yes". - On 02/25/22, the RN visited and documented "ALF (assisted living facility) staff manages all medications. Med list reviewed, no med changes or problems identified. Med rec done today with the nurse from primary care provider's office - 3 discrepancies noted. - On 02/28/22, the RN visited and documented a medication reconciliation was completed, the med list was reviewed and there were no changes or problems identified. Respiratory Inhaler On 02/15/22, the RN assessed the patient had COPD and moderate shortness of breath with exertion while walking distances less than 20 feet. The SN also noted the patient had an albuterol inhaler on the MAR at the ALF for as-needed use. Upon review of the ALF MAR, other medications that remained unaddressed were: Excedrin migraine, nystatin cream, Tylenol, Mylanta, and Robitussin. There was no evidence a full medication reconciliation had been completed with discrepancies resolved between discharge medications, primary care provider, ALF, and agency. On 03/03/22 at 9:30 AM, the record was reviewed with the Administrator, DPS, Nursing Manager, and Quality Nurse. No additional information was provided. 2. Patient #7 was admitted to the agency on 02/13/22 with a primary diagnosis of surgical amputation of the left great toe and secondary diagnoses of type 2 diabetes, osteomyelitis of the left foot, depression, anxiety, and hyperlipidemia. The RN failed to ensure the medication list was accurate and updated with changes. On 02/28/22, the surveyor conducted an observational home visit with the registered nurse (RN) to perform a peripherally inserted central catheter dressing change and medication reconciliation. The following medication discrepancies were identified: - the patient stated the citalopram was 40mg daily, showing the bottle, the agency profile said 20mg - the patient stated she takes "Xanax" for anxiety, the agency does not have Xanax listed The 02/13/22 comprehensive assessment note identified a discrepancy with the citalopram. The dosage on the referral list was 20mg daily and the "active bottle" was 40mg daily. The 02/14/22 patient activity note includes the medication citalopram was "confirmed" with the physician's office as 20mg daily. The RN failed to follow up with the patient and physician to determine why the discrepancy in the citalopram existed. Upon review of the 02/28/22 Visit Detail note and observation at the home visit, the RN failed to discuss the discrepancy with the patient and to contact the physician regarding both medications. On 03/01/22 at 1:30 PM, the record was reviewed with the Administrator, DPS, Nursing Manager, and Quality Nurse. No additional relevant information was provided.

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 a review of clinical records, and interviews with the Director of Patient Services (DPS), Nursing Manager, and clinical staff it was determined in 2 of 17 records (Patients # 5 and 6) the agency failed to develop complete and accurate plans of care that were individualized to address the total needs of the patients. Evidence as follows: HV 1. Patient # 6 was admitted to the agency on 02/03/20 with diagnoses of unstageable pressure ulcer (on left upper back), flaccid neuropathic bladder with cystostomy, chronic obstructive destructive pulmonary disease, hypertension, and atrial fibrillation. The 01/23/22 Plan of Care was incomplete as follows: NEPHROSTOMY TUBE SITE On 12/21/21 the patient was discharged from the hospital and returned home with a right-sided nephrostomy tube (catheter inserted through the skin directly into the kidney to drain urine). On 12/22/21 the registered nurse (RN) completed a resumption of care assessment. The 01/23/22 Plan of Care included wound care 3 times weekly to pressure ulcer on upper back and nephrostomy dressing change weekly. On 01/28/22 the registered nurse (RN) updated the Plan of Care with an order that “patient may sponge bathe only without getting site wet.” The order did not specify what “site” was not to get wet but was ordered by the wound care clinic, not the nephrology, clinic. On 02/28/22 the surveyor completed an observational home visit with the RN. During the visit the patient told the RN that the previous week she took a shower with her son’s assistance and he changed the dressing on her back. The RN instructed the patient she was to sponge bathe only, not just because of the dressing to her upper back, but also because she was not supposed to get the nephrostomy tube site wet. The patient said she did not know she was not supposed to get the nephrostomy site wet. From the 12/22/21 resumption of care assessment, through the observational home visit on 02/28/22, the RN failed to update the plan of care with instructions for the patient to keep the nephrostomy tube site dry. MEDICATION During the observational home visit, the RN assessed the patient’s pain. The patient stated that she had no pain but needed “to get more Advil.” As the RN reviewed the patient’s medications, the surveyor observed a tube of Voltaren gel in the container with the patient’s prescription bottles. After the visit was completed, the surveyor interviewed the patient. The patient stated that she took Advil a couple times a month for pain in her kidneys, and used Voltaren gel daily for pain in her right 4th finger. The 01/23/22 Plan of Care failed to include Advil and Voltaren gel. FINGER BRACE The patient showed the surveyor her right 4th finger which was deformed at the middle knuckle. The patient stated she injured it the previous July and had a brace that she was supposed to wear continuously, but she usually only wore it when she went to the physician or was having increased pain. The 01/23/22 Plan of Care failed to include instruction for use of finger brace. On 03/01/22 at 1:30 PM, the record was reviewed with the Administrator, DPS, Nursing Manager, and Quality Nurse. No additional information was provided 2. Patient # 5 was admitted to the agency on 01/03/22 with diagnoses of hydronephrosis, urinary tract infection, chronic kidney disease, and type 2 diabetes. On 01/24/22 the patient was hospitalized with sepsis secondary to a urinary tract infection. On 01/31/22 the registered nurse (RN) visited the patient for a resumption of care assessment and medications were updated to include Eliquis (a blood thinner) 2.5 mg twice daily. The RN documented performing education related to high-risk medications including Eliquis but failed to update the plan of care to include bleeding precautions or to monitor for bleeding. On 03/01/22 at 1:30 PM, the record was reviewed with the Administrator, DPS, Nursing Manager, and Quality Nurse. No additional information was provided. Failure to ensure the development of comprehensive and individualized plans of care can result in negative outcomes.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, 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. This ELEMENT is not met as evidenced by: Based on a review of clinical records, and interviews with the Director of Patient Services (DPS), Nursing Manager, and clinical staff, it was determined in 3 of 17 records (Patients # 6, 8, and 11 ) the agency failed to ensure: - This was evidenced by: Patient # 6 was admitted to the agency on 02/03/20 with diagnoses of unstageable pressure ulcer (left upper back), flaccid neuropathic bladder with cystostomy, chronic obstructive destructive pulmonary disease, hypertension, and atrial fibrillation (irregular heart beat). The patient was hospitalized 11/31/21-12/21/21 with pneumonia, right sided hydronephrosis secondary to kidney stones, and right sided nephrostomy tube placement (a tube placed directly into kidney to drain urine). The discharge summary from the hospital included the following medications: - diltiazem (for hypertension and atrial fibrillation) 240 mg extended release once daily - losartan (for hypertension) 50 mg once daily - famotidine (for heartburn / reflux) 20 mg once daily - atorvastatin (treats high cholesterol) 40 mg daily at bedtime On 12/22/21 the registered nurse (RN) visited the patient for a resumption of care assessment and documented the patient was missing all of the above listed medications. The RN notified the physician, documented the medications would be delivered by the pharmacy later that day, and the patient would be visited the following day for medication reconciliation. On 12/23/21 the RN documented she spoke with the patient at 9:25 AM and scheduled visit for 12:30-1 PM. At 12:45 PM the RN arrived at the patient’s apartment building and the patient did not answer the door buzzer. Another resident let the RN in to the building. The RN knocked on the patient’s apartment door and there was no answer. The RN left a note on the door requesting a call back and called the patient again at 1:15 PM. The RN documented at 4:30 PM there was no return call from the patient and the visit was canceled. The RN failed to notify the patient’s emergency contact, agency supervisor and/or physician that the patient was unable to be located to complete the visit; and failed to continue attempts to reach the patient and reschedule the visit for the following day. The surveyor reviewed of the agency’s “Difficulty Contacting Patient Policy,” dated November 2021, which stated “Due diligence will be done to make contact with the patient, their caregiver and/or the emergency contact person to confirm visit schedule and/or determine patient status when there is a concern.” The policy included that if the patient does not respond to home visit attempt: - A written note may be left on the patient’s door. - Supervisor is notified of unsuccessful visit attempt to discuss further plan for follow up. - If the ordered frequency cannot be met or care cannot be delivered on a specific date, the physician is notified. - Attempts to contact the patient continue as outlined above until the visit is made or confirmation of the patient status is ascertained. - All attempts to contact the patient, the emergency contact, and physician notification are documented in the medical record. On 12/27/21 at 12:15 PM the LPN visited the patient and documented the patient still had no medication delivered or picked up, and that the patient was going to go to the pharmacy to pick up medications that day. Vital signs included the patient’s heart rate was 116. The LPN documented a call to the physician’s office to report the patient had not taken any medications since resumption of care. The LPN failed to notify the physician of the elevated pulse rate, coordinate with the pharmacy or emergency contact to ensure the patient obtained medications, or notify the case manager or a supervisor that the patient was without medication since resumption of care on 12/22/21. On 12/28/21 the RN visited the patient and documented the patient still did not have medication from the pharmacy, the RN spoke with the pharmacist who stated they were on priority delivery for that evening. There was no evidence the RN specifically discussed what medications were to be delivered. On 12/30/21 the RN visited the patient and documented atorvastatin and famotidine still were not in the home. Atorvastatin was available at the pharmacy for pick up and patient agreeable to get, famotidine could be obtained over-the-counter until prescription can be filled. From the resumption of care visit on 12/22, through 12/30/21, agency staff failed to coordinate amongst themselves; or with the patient’s family, physician and pharmacist; to ensure the patient had all necessary medications. On 03/01/22 at 1:30 PM, the record was reviewed with Administrator, DPS, Nursing Manager and Quality Nurse. No additional information was provided. Patient # 8 was admitted to the agency 02/08/22 with diagnoses of atherosclerotic heart disease, pneumonia, hypertensive heart and chronic kidney disease, congestive heart failure (CHF), type 2 diabetes and dysphasia. On 02/21/22 the registered nurse visited the patient following hospitalization for pneumonia and CHF. The registered nurse documented the patient had a foley catheter, was refusing to allow her son to assist with any hygiene, and weekly aide visits were ordered. Aide visits plotted on the agency calendar for 02/23/22 and 03/02/22 were not completed. There was no documentation of coordination amongst agency staff related to why the aide visits were not completed, and no evidence the agency communicated with the physician regarding the agency’s inability to provide aide service. On 03/04/22 at 9:30 AM, the record was reviewed with Administrator, DPS, Nursing Manager and Quality Nurse. No additional information was provided. Patient # 13 was admitted to the agency 05/22/21 with diagnoses of hypertensive heart and chronic kidney disease, acute and chronic kidney failure, congestive heart failure, atrial fibrillation, chronic obstructive pulmonary disease and epilepsy. The 05/22/21 Plan of Care included aide services 3 times weekly. Review of the patient’s record revealed from the time of agency admission, through discharge on 08/31/21, only one aide visit (05/26/21) was completed. There was no documentation related to why the aide visits were not completed, and no evidence the agency communicated with the physician regarding the agency’s inability to provide aide service as ordered. On 03/04/22 at 9:30 AM, the record was reviewed with Administrator, DPS, Nursing Manager and Quality Nurse. No additional information was provided. Patient #11 was admitted to the agency on 01/15/22 with a primary diagnosis of lumbago with sciatica, type 2 diabetes, chronic kidney disease, heart failure, COPD, hyperlipidemia, ASHD, and long-term use of insulin. On 01/15/22, the physical therapist (PT) visited and completed a start of care assessment which included a phone call to the physician's office on 01/17/22 to obtain authorization for visits: 1/week for 1 week, and 2/week for 5 weeks. On 01/27/22, the PT called the patient to confirm the visit and the daughter requested to cancel as the patient wasn't feeling well. On 02/15/22 the PT called the physician to obtain further visits for the patient after hospitalization. The PT documented "this PT is unavailable between 02/17/22 - 02/28/22". An alternate PT was offered but the patient preferred to wait for the return of the known PT and would wait to resume PT sessions. There was no evidence the PT notified the therapy supervisor or the physician of the patient's decision to temporarily stop PT while the PT was unavailable or of the missed visits. On 02/11/22 after further hospitalization, the agency added orders for a home health aide (HHA): 1/week for 4 weeks. The aide visits on the agency calendar for 02/14, 02/21, and 02/28 were not completed. There was no documentation why the aide visits were not completed and no evidence the agency communicated with the physician about the agency’s inability to provide aide service. On 03/01/22 at 01:30 PM, the record was reviewed with the Administrator, DPS, Nursing Manager, and Quality Nurse. No additional information was provided.

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 7 observational home visits with skilled nurses (SN) and physical therapists (PT), review of agency policies and procedures, and interviews with the Director of Patient Services (DPS) and Nursing Manager, it was determined during 1 of 7 visits (patients #7), the registered nurse (RN) failed to follow accepted standards of infection control practices. Evidence as follows: Patient #7 was admitted to the agency on 02/13/22 with a primary diagnosis of care after surgical amputation and secondary diagnoses of type 2 diabetes, osteomyelitis of the left foot, depression, anxiety, and hyperlipidemia. On 02/28/22 the surveyor conducted an observational home visit with the registered nurse (RN) to perform a peripherally inserted central catheter (PICC) dressing change and medication reconciliation. The surveyor observed the following: Prior to beginning the PICC line dressing change, the RN performed hand hygiene and donned clean gloves. The RN then placed a drape on the couch and added several items to the field. The RN picked up the patient's cat, returning it to the floor away from the field without changing gloves and performing hand hygiene. The RN continued to arrange items on the clean field items with the gloves that had touched the cat. The RN removed the soiled gloves, performed hand hygiene, opened the dressing kit and donned the gloves within the kit, and proceeded with the dressing change, handling items that had been touched by the soiled gloves. The Administrator, DPS and Clinical Manager acknowledged gloves should have been changed immediately after touching the cat. The Core Infection Prevention and Control Practices for Safe Care Delivery in All Healthcare Settings and recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) included the following strong recommendations for hand hygiene in healthcare settings. Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications: - Immediately before touching a patient - Before performing an aseptic task (e.g., 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 touching a patient or the patient's immediate environment - After contact with blood, body fluids, or contaminated surfaces - Immediately after glove removal Reference: https://www.cdc.gov/handhygiene/providers/guideline.html Failure to ensure the RN is oriented to agency policies and procedures regarding standard precautions for the prevention and transmission of infectious agents has the potential for unmet patient needs and possible negative patient outcomes. On 03/01/22 at 1:30 PM, the record was reviewed with the Administrator, DPS, Nursing Manager, and Quality Nurse. No additional relevant information was provided.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on a review of the employee rosters, documentation of vaccination status, and interviews with the Director of Patient Services, it was determined the agency failed to ensure policies were created Evidence as follows: On 02/23/22, the Surveyor requested a list of all employees and documentation of their Covid-19 vaccination status. 100% of required employees were vaccinated. On 02/24/22, the Surveyor requested the agency's Covid-19 policies and procedures. The Director of Patient Services stated the agency didn't have policies and procedures specific to the mandated Covid-19 vaccination of employees. Failure to develop policies and procedures to ensure all staff are vaccinated can lead to the spread of disease and negative outcomes for patients and staff. The agency failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on a review of clinical records for patients receiving home health aide (HHA) service, and interviews with the Director of Patient Services (DPS) and Nursing Manager, it was determined in 2 of 17 records (patients #8 and 13), the skilled nurse (SN) failed to develop complete and accurate aide written instructions. Evidence as follows: Patient # 8 was admitted to the agency on 02/08/22 with diagnoses of atherosclerotic heart disease, pneumonia, hypertensive heart and chronic kidney disease, congestive heart failure, type 2 diabetes and dysphasia (difficulty swallowing). On 02/21/22 the registered nurse (RN) visited the patient following hospitalization for pneumonia and CHF. The registered nurse documented the patient had a foley catheter and was refusing to allow her son to assist with any hygiene. 02/21/22 physicians’ orders included: - aide once weekly - stage 2 pressure sore left coccyx area open to air, may apply balmex daily as needed - DIET: nectar thick liquids, mechanical soft, “HH DM” The 02/21/22 aide care plan failed to include: - aspiration / swallowing precautions - any instruction regarding bathing / care to buttocks The aide care plan included SKIN – lotion, but failed to specify what type of lotion and where it was to be applied. On 02/24/22 the RN documented buttocks and backs of thighs were red and balmex was applied; 2 small fluid filled blisters were present on right shin, gauze was placed over the blisters and secured with tubigrip. The RN failed to update the aide care plan to include any instruction regarding bathing / care to buttocks and right lower leg. On 03/04/22 at 9:30 AM, the record was reviewed with Administrator, DPS, Nursing Manager and Quality Nurse. No additional information was provided. Patient # 13 was admitted to the agency on 05/22/21 with diagnoses of hypertensive heart and chronic kidney disease, acute and chronic kidney failure, congestive heart failure, atrial fibrillation, chronic obstructive pulmonary disease and epilepsy (seizures). The 05/22/21 Plan of Care included aide services 3 times weekly. On 05/22/21 the registered nurse visited the patient and documented in the initial assessment that the patient was bedbound, used a lift sheet for positioning, was incontinent, used diapers and barrier cream to buttocks. The aide care plan dated 05/22/21 failed to include: - bedbound status - instruction to position with a lift sheet - incontinence product(s) - diaper and barrier cream - seizure precautions On 03/04/22 at 9:30 AM, the record was reviewed with Administrator, DPS, Nursing Manager and Quality Nurse. No additional information was provided. .