Elite Home Health

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on clinical record review and staff interview, it was determined the Agency failed to ensure an adherence to professional skills for Intravenous infusion care during the observed care provided for 2 of 2 (#7 and #13) patients with Peripherally Inserted Central Catheter (PICC) lines observed during home visits. This deficient practice posed a risk of serious harm for all patients on census with a PICC line as the failed practice could cause systemic infections and hospitalizations. Findings follow: On 01/13/26 at 10:40 A.M., a home visit to the patient identified in Clinical record #7 was conducted with Agency Personnel #1 to observe the SN perform PICC (Peripherally Inserted Central Catheter) dressing change and site care. The SN removed the old clear dressing from the patient’s left upper chest; the catheter securement device did not easily remove from the patient’s catheter. The SN picked up a pair of scissors that were lying on the table beside the patient and used them to try to loosen the catheter securement device, laid the scissors down on the table again, and continued to try to remove the device. The SN picked the scissors up from the table again and cut the catheter securement device and removed it from around the catheter tubing. The PICC had 2 lumens. One lumen was connected to a cannister that contained Dobutamine infusing at 6.6 ml(milliliters)/HR (hour). The patient’s daughter stated, “it runs continuously.” The scissors were not observed to be cleaned before or after removing them from the table with no barrier placed on it. a. Review of Agency Policy/Procedures for PICC dressing changes showed, “ To remove the old dressing, lift edge of dressing perpendicular to the skin toward the insertion site. Remove catheter securement device and chlorhexidine-impregnated sponge (if present) Avoid tugging on the catheter, use of scissors, or other sharp objects near the catheter.” Review of Clinical Record #13 with a start of care date of 01/11/26 revealed a patient with a diagnosis of Acute Pyelonephritis and history of kidney transplant. The Home Health Certification and Plan of Care with a certification period of 01/11/26-03/11/26 documented, “…Skilled Nurse to perform…injection cap change once a week and with each lab draw…Extension tube change once a week and with each lab draw…” and “…Skilled Nurse to perform site care for infusion access device…once a week... to right upper arm…using sterile technique…”During the home visit on 01/14/26 at 12:30 p.m., the Registered Nurse (RN) did not prime the extension tubing, did not apply a new injection cap, and the skilled nurse broke sterile field by opening the non-sterile stat-lock package with sterile gloves, applied the stat-lock, and still without changing to a new pair of sterile gloves, applied the antimicrobial disk at the insertion site and covered the dressing.Review of Agency Policy/Procedures for PICC dressing changes noted, “...Remove the old dressing...Discard [old] dressing...remove gloves, perform hand hygiene, and don sterile gloves...” and “...Sterility will be maintained throughout this procedure...”The standard of practice according to How to Prime an Extension Set: A Critical Guide to IV Safety is to prime the extension line with saline prior to attaching to the PICC line to ensure that a large amount of air does not infuse into the patient which could cause harm. This article documented, “...Because extension sets are sterile but contain air when they are removed from their packaging, they must be primed before being connected to a patient’s catheter. Failure to remove this air can lead to a serious medical emergency known as an air embolism, where air bubbles enter the bloodstream and can block blood flow...” The standard of practice according to CDC is to change the injection caps (“...add-on devices...”) weekly as documented, “...In patients not receiving blood, blood products or fat emulsions, replace administration sets that are continuously used, including secondary sets and add-on devices, no more frequently than at 96-hour intervals...but at least every 7 days...” per the website location Background Information: Strategies for Prevention of Catheter-Related Infections in Adult and Pediatric Patients | Infection Control | CDC .”

“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 clinical record review and staff interview, it was determined the Agency failed to ensure infection control practices were followed during the observed care provided for 2 of 2 (#7 and #13) Peripherally Inserted Central Catheter (PICC) lines observed during home visits. This deficient practice posed a risk of potential harm for all patients on census as the failed practice could cause a systemic infection. Findings follow: On 01/13/26 at 10:40 A.M., a home visit to the patient identified in Clinical record #7 was conducted with Agency Personnel #1 to observe the SN perform PICC (Peripherally Inserted Central Catheter) dressing change and site care. The SN removed the old clear dressing from the patient’s left upper chest; the catheter securement device did not easily remove from the patient’s catheter. The SN picked up a pair of scissors that were lying on the table beside the patient and used them to try to loosen the catheter securement device, laid the scissors down on the table again, and continued to try to remove the device. The SN picked the scissors up from the table again and cut the catheter securement device and removed it from around the catheter tubing. The PICC had 2 lumens. One lumen was connected to a cannister that contained Dobutamine infusing at 6.6 ml(milliliters)/HR (hour). The patient’s daughter stated, “it runs continuously.” The scissors were not observed to be cleaned before or after removing them from the table with no barrier placed on it. a. Review of Agency Policy/Procedures for PICC dressing changes showed, “ To remove the old dressing, lift edge of dressing perpendicular to the skin toward the insertion site. Remove catheter securement device and chlorhexidine-impregnated sponge (if present) Avoid tugging on the catheter, use of scissors, or other sharp objects near the catheter.” Review of Clinical Record #13 with a start of care date of 01/11/26 revealed a patient with a diagnosis of Acute Pyelonephritis and history of kidney transplant. a. The Home Health Certification and Plan of Care with a certification period of 01/11/26-03/11/26 documented, “…Skilled Nurse to perform site care for infusion access device…once a week... to right upper arm…using sterile technique…” b. On 01/14/26 at 12:30 p.m., during a home visit, the skilled nurse broke sterile field by opening the non-sterile stat-lock package with sterile gloves, applied the stat-lock, and still without changing to a new pair of sterile gloves, applied the antimicrobial disk at the insertion site and covered the dressing. c. Review of Agency Policy/Procedures for PICC dressing changes noted, “...Remove the old dressing...Discard [old] dressing...remove gloves, perform hand hygiene, and don sterile gloves...” and “...Sterility will be maintained throughout this procedure...” On 01/14/2026 Agency staff member #2 verified proper infection control was not followed by the SN for Patient #7 and #13.”

“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 clinical record review and staff interview, it was determined the Agency failed to ensure the agency nurse conducted a Drug Regimen Review (DRR - review of medication regimen related to potential adverse effects, drug reactions, significant side effects or significant drug interactions) to include all current and added medication the patient was taking in 2 (#14 and # 15) of 17 (#1 - #17) clinical records reviewed. This deficient practice posed a risk of potential harm for all patients on census by inhibiting the Skilled Nurse (SN) and Physician’s ability to make informed decisions regarding the patient’s medication regimen related to potential adverse effects, drug reactions, significant side effects or significant drug interactions. Findings follow: Review of Clinical Record # 14 with a start of care date of 08/01/24 revealed a patient with a diagnosis of open wound left thorax, chronic ulcer left and right lower leg. The Home Health Certification and Plan of Care with a certification period of 11/24/25 – 01/22/26 documented, “… Levemir …33 units… at bedtime daily for Diabetic Mellitus…” and “… DME [Durable Medical Equipment] … oxygen supplies…”During the home visit on 01/14/26, the patient was using oxygen via nasal cannula.The vital signs record documented O2 at 2liters in use.There was no order for oxygen documented on The Home Health Certification and Plan of Care.There was no evidence in the clinical record that Levemir nor Oxygen were checked for adverse effects, drug reaction, significant drug interactions.On 01/15/26, the Clinical Director and the Executive Director of the agency were asked to provide any documentation for a completed drug regimen review to include Levemir and Oxygen. The Executive Director stated they could not provide the requested documentation.Review of Clinical Record # 15 with a start of care date of 01/08/26 revealed a patient with a diagnosis of displaced intertrochanter fracture of left femur. The Home Health Certification and Plan of Care with a certification period of 01/08/26 – 03/08/26 documented “…O2 at 2.5 L [liters]…”There was no evidence that Oxygen was checked for adverse effects, drug reaction, significant drug interactions.On 01/15/26, the Clinical Director and the Executive Director of the agency were asked to provide any documentation for a completed drug regimen review to include Oxygen. The Executive Director stated they could not provide the requested documentation.”

“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 clinical record review and staff interview, it was determined the Agency failed to ensure the Plan of Care included current orders for 2 (#10 and #14) of 17 (#1 - #17) clinical records reviewed. This failed practice had the potential to affect all clients on census by inhibiting the Skilled Nurse (SN) and Physician’s ability to make informed decisions regarding continued care and services and the risk of error in care delivery would be increased. Findings follow: Review of Clinical Record #10 with a start of care date of 10/26/25 revealed a patient with a diagnosis of Hepatic Failure. A Visit Note Report dated 12/30/25 documented, “…Interventions Provided…[Name] ordered Chest XRAY…”A Visit Note Report dated 01/07/26 documented, “…. Interventions Provided…Received wound orders from APRN [Name]…”The Home Health Certification and Plan of Care with a certification period of 12/25/25 – 02/22/26 did not include the orders 12/30/25 and 01/07/26. There were no subsequent physician orders for the Chest XRAY nor the wound care. Review of Clinical Record # 14 with a start of care date of 08/01/24 revealed a patient with a diagnosis of open wound left thorax, chronic ulcer left and right lower leg. The Home Health Certification and Plan of Care with a certification period of 11/24/25 – 01/22/26 documented, “… DME [Durable Medical Equipment] … oxygen supplies…”During the home visit on 01/14/26, the patient was using oxygen via nasal cannula.The vital signs record documented O2 at 2liters in use.There was no order for oxygen documented on The Home Health Certification and Plan of Care nor any subsequent physician’s orders for oxygen use.”