Stat Home Health - Cenark, LLC

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on observations by home visits, clinical record review, Agency’s Policy and Procedure, current standard of practice by Centers for Disease Control (CDC) and staff interviews, it was determined the agency failed to ensure Infection Control and Prevention practices were followed for 3 (#1, #2, and #4) of 7 (#1-#7) home visit observations conducted which included wound care and Peripherally Inserted Central Catheter (PICC) line dressing change. This failed practice had the potential for harm as there may be systemic infections as a result of staff not changing gloves, using hand sanitizer, or adhering to a sterile process during a PICC line dressing change. This resulted in a condition level failed practice. See G682 for findings”

“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 observations by home visits, clinical record review, Agency’s Policy and Procedure, current standard of practice by Centers for Disease Control (CDC) and staff interviews, it was determined the agency failed to ensure Infection Control and Prevention practices were followed for 3 (#1, #2, and #4) of 7 (#1-#7) home visit observations conducted which included wound care and Peripherally Inserted Central Catheter (PICC) line dressing change. This failed practice had the potential for harm as there may be systemic infections as a result of staff not changing gloves, using hand sanitizer, or adhering to a sterile process during a PICC line dressing change. This resulted in a condition level failed practice. Findings follow: A. The Agency’s Policy and Procedure titled, “Peripherally inserted central catheter (PICC) dressing change, home care” documented, “...Put on a mask, Perform hand hygiene. Open the supplies and prepare a sterile field using a sterile drape. Using sterile technique, place the supplies on the sterile field. Perform hand hygiene, put on gloves to comply with standard precautions.... remove the existing dressing by beginning at the device hub... remove and discard your gloves, perform hand hygiene, put on sterile gloves...” B. The 02/27/24 Centers for Disease (CDC) article titled, “Clinical Safety: Hand Hygiene for Healthcare Workers” documented, “...when to clean your hands...after contact with blood, body fluids or contaminated services.... When to change gloves and clean hands.... if they look dirty or have blood or body fluids on them after completing a task...if moving from work on a soiled body site to a clean body site on the same patient...” This article is located at https://www.cdc.gov/clean-hands/hcp/clinical-safety/index.html. C. Clinical Record #1 with a Start of Care (SOC) date of 05/13/26 revealed a patient with a diagnosis of Deep Tissue Injury to left heel and Malignant Neoplasm of the Brain. The Home Health Certification and Plan of Care dated 07/12/26 - 09/09/26 documented to clean the left heel wound with wound cleanser and pat dry, apply Hydrofera Blue and Santyl to wound bed, cover with Optifoam. On 08/12/26 at 10:15 a.m., during a home visit, the nurse provided wound care. After finishing with wound care to the back of the patient’s leg, she did not change her gloves, nor use hand sanitizer. After removing the soiled dressing on the left heel and before applying the clean dressing, she did not change her gloves and use hand sanitizer. The nurse did not clean the wound. On 08/12/26 at 11:00 a.m., the nurse was asked when she should change her gloves. She stated, “When going from one wound to the next...” D. Clinical Record #2 with a SOC date of 07/10/26 revealed a patient with a diagnosis of Type 2 Diabetes Mellitus with foot ulcer and history of Kidney Transplant. The Home Health Certification and Plan of Care dated 07/10/26 - 09/07/26 documented for the PICC line dressing change, “...Remove old dressing, cleanse site with Chloraprep....allow to dry. Apply biopatch and/or new statlock, cover with transparent dressing....” On 08/11/26 at 8:15 a.m., the nurse was observed performing PICC line dressing change. The nurse had sterile gloves on and then touched the edges of the PICC dressing kit and turned the items over on to the sterile barrier. The nurse did not use hand sanitizer when changed into the sterile gloves the second time. On 08/11/26 at 8:55 a.m., the nurse was asked when she should use her hand sanitizer and she stated when she goes from a dirty to a clean area. E. Clinical Record #4 with a SOC date of 07/10/26 revealed a patient with a diagnosis of Stage 2 Pressure Ulcer. The Home Health Certification and Plan of Care dated07/10/26 - 09/07/26 documented, “...Skilled nurse to perform... pressure ulcer care to right side, right low back, and RLE [right lower extremity] ...” On 08/12/26 at 9:36 a.m., a home visit for wound care was completed. The Skilled Nurse (SN) was cleaning the buttock area wounds with saline moistened gauze. After completing the dressing to the buttock area, SN then moved to the rib area and began cleaning the wounds located on the ribs without performing hand hygiene or donning clean gloves. F. On 08/14/26 at 11:00 a.m., the Agency Representatives were interviewed and in agreement that changing gloves and hand hygiene were required during wound dressing changes as per current medical standards and the PICC dressing change is a sterile procedure.”

“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 review of Clinical Records, Agency Policy and Procedure, observation during home visits and staff interview, the Skilled Nurse (SN) failed to include all medications the patient was taking during the drug regimen review in 1 (#1) of 17 (#1 - #17) Clinical Records reviewed. This failed practice had the potential to affect all patients currently on census in that the Clinician may be unaware of all medications being taken by the patients and could fail to identify and notify the Physician of potential reactions, ineffective drug therapy, interactions, duplicate drug therapy and noncompliance. Findings follow: Review of Clinical Record #1 with a Start of Care (SOC) date of 05/13/26 revealed a patient with a diagnosis of Deep Tissue Injury Left heel, and Malignant Neoplasm of the Brain. The agency’s Policy and Procedure titled, “Medication Reconciliation” documented, “The Agency will reconcile patient’s medications at time of admission and on an ongoing basis...” During a home visit on 08/12/26, the patient’s spouse was interviewed, and the medication list provided by the Agency was compared to what the spouse provides to the patient (Medication Reconciliation). She stated the patient doesn’t take Vitamin D anymore, the Hydrocortisone 20mg is a total of 100mg [milligrams] a day rather than 120mg, she doesn’t give him Silodosin but rather gives him Saw Palmetto. She further stated she has been giving him Tylenol #3 for pain, Trazodone and he was supposed to be on Potassium that was ordered from a recent Emergency Room visit, but she gives him an Electrolyte 100mg instead. The nurse stated to the patient’s spouse, “Yes, we talked about that [Tylenol #3 and Trazodone]”. As these medications were not on the medication profile, there has not been a medication regimen review completed. On 08/12/26 the Agency Representatives were asked to provide any further information. On 08/14/26 at 11:00 a.m., the Agency Representatives confirmed the findings.”

“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 Clinical Record review, Agency Policy and Procedure, and Agency staff interviews, the Skilled Nurse (SN) failed to ensure the patients Plan of Care (POC) included the required elements of all medication and treatments in 2 (#1 and #2) of 7 (#1 -#7) clinical records reviewed. This failed practice had the potential to result in harm for all patients on census by inhibiting the SN and Physician’s ability to make informed decisions regarding the patients’ medication and treatment regimen and potential subsequent adverse effects or infection. Findings follow: Review of Clinical Record #1 with a Start of Care (SOC) date of 05/13/26 revealed a patient with a diagnosis of Deep Tissue Injury Left heel, and Malignant Neoplasm of the Brain. During a home visit on 08/11/26, the patient’s spouse was interviewed. The agency’s medication list provided to the surveyor against what she provides to him were reviewed. She stated the patient doesn’t take Vitamin D anymore, the Hydrocortisone 20mg is a total of 100mg [milligrams] a day rather than 120mg, she doesn’t give him Silodosin but rather gives him Saw Palmetto. She further stated she has been giving him Tylenol #3 for pain, Trazodone and he was supposed to be on Potassium that was ordered from a recent Emergency Room visit, but she gives him an Electrolyte 100mg instead. The nurse stated to the patient’s spouse, “Yes, we talked about that [Tylenol #3 and Trazodone]”. Additionally, during the home visit on 08/11/26 the nurse had provided wound care to both upper arms prior to the surveyor’s arrival. There were visible large, open wounds on each upper arm. The patient’s spouse reported these were skin tears and more skin was disturbed when an adherent bandage was removed. The agency nurse reported that the product Triad (zinc oxide-based wound treatment) was being used. The wound record report and Home Health Certification and Plan of Care had no documentation of the wounds, nor the treatment. Review of Clinical Record #2 with a SOC date of 07/10/26 revealed a patient with a diagnosis of Type 2 Diabetes Mellitus with Foot Ulcer, history of Kidney transplant. On 08/11/26, the patient’s spouse was interviewed. The agency’s medication list provided to the surveyor against what she provides to him were reviewed. She stated the patient takes Amlodipine as needed rather than daily, the Ceftazidime 1 gram is given every 24 hours but is documented, “as directed”. The Tacrolimus is listed as 1mg, but she gives 3 mg, and Vancomycin is listed as daily but is given every 48 hours. The Agency’s Policy and Procedure titled, “Plan of Care-CMS [Centers for Medicare and Medicaid Services] #485 and Physician/ Practitioner’s Orders” documented, “...Each patient must receive an individualized written plan of care, including any revisions or additions...The individualized plan of care must include the following: ...All medications and treatment...” On 08/12/26 the Agency Representatives were interviewed. They were asked to provide any further documentation regarding the medication discrepancies and the wound which was treated but was not listed on the Plan of Care. On 08/14/26 at 11:00 a.m., the Agency Representatives were not able to provide further documentation and confirmed findings.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation during home visits, clinical record review, Agency Policy and Procedure, and staff and family interviews, it was determined the agency failed to ensure there was an accurate medication profile in the patient’s home for 6 (#1, #2, #4, #5, #6, #7) of 7 (#1 -#7) home visits. This failed practice had the potential to affect all patients on census in that an inaccurate or absent medication profile may lead to medication errors or misinformation to the physician who develops the patient’s plan of care. Findings follow: The agency’s Policy and Procedure titled, “Medication Profile” documented, “...All prescribed medications, over the counter (OTC) medications and home remedies will be documented on the medication profile.... The medication profile will be reviewed every home visit and updated as changes occur...The Agency must provide the patient and caregiver with a copy of written instructions outlining patient medication schedule/instructions...”Review of Clinical Record #1 with a Start of Care (SOC) date of 05/13/26 revealed a patient with a diagnosis of Deep Tissue Injury Left heel, and Malignant Neoplasm of the Brain. During a home visit on 08/12/26, the patient’s spouse was interviewed. The agency’s medication list provided to the surveyor against what she provides to him were reviewed. She stated the patient doesn’t take Vitamin D anymore, the Hydrocortisone 20mg is a total of 100mg [milligrams] a day rather than 120mg, she doesn’t give him Silodosin but rather gives him Saw Palmetto. She further stated she has been giving him Tylenol #3 for pain, Trazodone and he was supposed to be on Potassium that was ordered from a recent Emergency Room visit, but she gives him an Electrolyte 100mg instead. The nurse stated to the patient’s spouse, “Yes, we talked about that [Tylenol #3 and Trazodone]”. Review of Clinical Record #2 with a SOC date of 07/10/26 revealed a patient with a diagnosis of Type 2 Diabetes Mellitus with Foot Ulcer, history of Kidney transplant. On 08/11/26, the patient’s spouse was interviewed. The agency’s medication list provided to the surveyor against what she provides to him were reviewed. She stated the patient takes Amlodipine as needed rather than daily, the Ceftazidime 1 gram is given every 24 hours but is documented, “as directed”. The Tacrolimus is listed as 1mg, but she gives 3 mg, and Vancomycin is listed as daily but is given every 48 hours. During Home visits on 08/11/26 and 08/12/26, it was noted Clinical Records #4 - #7 did not have a current and active medication list at the patient’s home. On 08/12/26, the Agency Representatives were asked to provide any further documentation. On 08/14/26 at 11:00 a.m., the Agency Representatives confirmed the findings.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on observation during home visits, clinical record review and staff interview it was determined the agency failed to document wound assessments and responses to wound care for 2 (#1 and #12) of 8 (#1 - #7, and #12) clinical records reviewed that had wounds. This failed practice had the potential to affect all patients on census that had wounds as the wounds may worsen, have infections, or stall in progress of healing without timely interventions by change of the plan of care. Findings follow: A. Review of Clinical Record #1 with a Start of Care (SOC) date of 05/13/26 revealed a patient with a diagnosis of Deep Tissue Injury Left heel, and Malignant Neoplasm of the Brain. During a home visit on 08/12/26, the nurse had already provided wound care to both upper arms prior to the surveyor’s arrival. There were visible large, open wounds on each upper arm which were partially covered with a white paste. The patient’s spouse reported these were skin tears and more skin was disturbed when an adherent bandage was removed. The agency nurse reported that the product Triad (zinc oxide-based wound treatment) was being used. The wound record report and Home Health Certification and Plan of Care had no documentation of the wounds, treatment orders, nor the progress of wound healing. B. Review of Clinical Record #12 with a SOC date of 02/11/26 revealed a patient with a diagnosis of Pressure Ulcer Stage III sacrum, Deep Tissue Injury (DTI) Right heel, Stage III ulcers to right and left upper legs, left heel pressure ulcer, and Quadriplegia. The Wound Record Report documented the following: The last wound measurement was 07/02/26 for the sacral wound. The measurements were exactly the same for 06/16/26, 06/30/26, and 07/02/26 which indicates this wound had stalled in healing. On 07/14/26 and 07/28/26 a nurse documented the reason for the wound not assessed as, “...Covered by non-removable dressing or device...” The patient did not have a non-removable dressing. The DTI to right heel was last measured on 07/28/26 and was 6.8 x(by) 5x0.1 compared to 4x3x1 from the prior measurement on 07/02/26. On 07/14/26 a nurse documented the reason for the wound not assessed as, “...Covered by non-removable dressing or device...” The patient did not have a non-removable dressing. The left upper leg wound was last assessed 07/28/26 and was 7x4x0.1 as compared to 4x3x0.1 from the prior measurement on 07/02/26. On 07/14/26 a nurse documented the reason for the wound not assessed as, “...Covered by non-removable dressing or device...” The patient did not have a non-removable dressing. The right upper leg wound was last assessed on 07/28/26 and measured 4x2x0.1 as compared to 3.1x2x0.1 from the prior assessment on 07/02/26. On 07/14/26 a nurse documented the reason for the wound not assessed as, “...Covered by non-removable dressing or device...” The patient did not have a non-removable dressing. The left heel ulcer identified on 07/09/26 had no measurement and last assessment was dated 07/28/26. On 07/14/26 a nurse documented the reason for the wound not assessed as, “...Covered by non-removable dressing or device...” The patient did not have a non-removable dressing. C. On 08/12/26 the Agency Representative was asked to provide any further information. On 08/14/26 at 11:00 a.m., the Agency Representative confirmed the findings.”