Tennessee Quality Care - Home Health

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on policy review, medical record review, and interview, the agency failed to update the medication profile for 4 of 7 (Patient #2, #3 #5 and #7) sampled patients observed during home visits. The findings included: Review of the agency’s “MEDICATION PROFILE,” policy revised 12/2025, revealed “…Patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medication and new…discontinued medications…” 2. Medical record review for Patient #2 revealed a start of care date of 4/4/2026, with diagnoses of Diabetes Mellitus, Acquire Absence of Right and Left Leg Below Knee, Stage 3 Sacral Pressure Ulcer, and Hypertension. Review of the “Home Health Certification and Plan of Care” for the certification period from 4/4/2026 to 6/2/2026, revealed the following medication orders: Fenofibrate Nanocrystalized (treats hyperlipidemia)145 milligram (mg) orally daily Furosemide (removes excess fluid from the body) 20 mg orally daily Jardiance (treats diabetes) 10 mg orally daily Losartan (treats high blood pressure) 25 mg orally daily Pioglitazone (treats diabetes) 30 mg orally daily Review of the hospital discharge medication list revealed the following medication orders: Exenatide (treats diabetes) 5 mcg (micrograms)/1 ml (milliliter) sq (subcutaneous) Fluconazole (antifungal) 200 mg orally daily Glucophage (treats diabetes) 750 mg orally daily Observations in Patient #2’s home on 4/20/2026 at 1:45 PM, revealed the following medications in the home: 2/27/2026 Amlodipine (treats high blood pressure) 5 mg orally daily 2/26/2026 Melatonin (treats insomnia) 3 mg orally as needed Over the counter (OTC) D3 (supplement) 1,000 IU (international units) orally daily OTC Multivitamin (supplement) orally daily Observations in Patient #2’s pill planner revealed an unidentified blue pill 3. Medical record review for Patient #3 revealed a start of care date of 1/30/2026 with diagnoses including Osteoporosis, Diabetes Mellitus, Rheumatoid Arthritis, and Hypertension. Review of the “Home Health Certification and Plan of Care” for the certification period from 3/31/2026 to 5/29/2026, revealed the following medication orders: Diphenhydramine (treats allergy) 25 mg orally bedtime Ferrous Sulfate (supplement) 325 mg orally daily Fluconazole (antifungal) 150 mg orally daily Pepcid (treats acid reflux) 20 mg orally twice daily Senna Lax (treats constipation) 8.6 mg orally at bedtime Observations in Patient #3’s home on 4/20/2026 at 12:45 PM, revealed the following medications in the home: D3 2,000 IU by mouth daily During an interview on 4/20/2026 at 1:00 PM, Patient #3 stated she takes Diphenhydramine as needed and not daily, finished and not taking Ferrous Sulfate and Fluconazole, Pepcid, or Senna Lax, and takes Prednisone as needed. 4. Medical record review for Patient #5 revealed a start of care date of 3/13/2026 with diagnoses of Acute Kidney Failure, Diabetes Mellitus, Stage 5 Chronic Kidney Disease, and Dementia. Review of the “Home Health Certification and Plan of Care” for the certification period from 3/13/2026 to 5/11/2026, revealed the following medication orders: Pantoprazole 40 mg orally before breakfast Quetiapine 25 mg orally daily Observations in Patient #5’s home on 4/21/2026 at 3:00 PM, revealed the following medications in the home: OTC Calcium Citrate 500 (supplement) mg orally daily OTC Equate Acetaminophen (treats pain) 650 mg orally daily 2/26/2026 Metoclopram (treats acid reflux) 10 mg orally daily OTC Melatonin 3 mg orally at bedtime 3/26/2026 Carb/Leva 25 mg-100 (treats tremors) mg orally three times daily During an interview on 4/21/2026 at 3:15 PM, Patient #5 stated she no longer takes the Quetiapine and takes Pantoprazole as needed. 5. Medical record review for Patient #7 revealed a start of care date of 3/11/2026 with diagnoses including Orthopedic Aftercare, Osteomyelitis of Vertebra, Lymphedema and Sepsis. Review of the “Home Health Certification and Plan of Care” for the certification period from 3/11/2026 to 5/9/2026, revealed the following medication orders: Cefazolin (used to treat infection) 2 Gram/100 milliliters (ml) in 0.9 percent (%) Sodium Chloride (used as a carrier for drug delivery) Intravenous (into a vein) Solution, continuous infusion, daily. Magnesium (used for electrolyte balance supplement) 400 milligrams (mg) capsule orally daily Methocarbamol (used to treat painful muscles) 500 mg tablet one orally three times daily Observations in Patient #7’s home on 4/21/2026 at 12:45 PM, revealed the following medications in the home: Cefazolin 2 Gram Solution for injection over 3 to 5 minutes every 8 hours Melatonin (used to treat insomnia) 10 mg capsule orally at bedtime Magnesium 200 mg capsule one orally daily During an interview on 4/21/2026 at 12:46 PM, Patient #7 stated Cefazolin was changed to three times a day on 3/25/2026, Melatonin started the middle of March and had taken Magnesium 200 mg for the past 3 years. Patient #7 stated the Methocarbamol was stopped at the end of February. During an interview on 4/21/2026 at 12:48 PM, Registered Nurse (RN) #1 stated the medications were not updated on the medication list. During an interview on 4/22/2026 at 10:29 AM, the Area Vice President Staff stated all medication in the home are listed on the medication list, staff are to check medications each visit, if the patent was discharged from the hospital the staff are to review the discharge medication list, check pill bottles and notify the doctor of any changes.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on policy review, medical record review, and interview, the agency failed to document the day service was rendered for 7 of 12 (Patient #4, #5, #7, #8, #9, #10, #11) patients reviewed. The findings include: Review of the agency’s “ENTRIES INTO THE CLINICAL RECORD,” revised 12/2025 revealed “…documentation in the clinical record will be timely…and reflect the care or services provided…All documentation is preferred to be stated and completed as much as possible in the patients home…When unable to complete documentation in the patients home, it must be completed and sent back to the office electronically by the end of the workday…extenuating circumstances that prevent the documentation to be transferred electronically by the end of the workday, it will be acceptable to submit within 24 hours of the visit…” Review of the medical record revealed Patient #4 was admitted to the agency on 4/2/2025, with diagnoses of Change or Removal of Drains, Malignant Neoplasm of Upper Lobe, Right Bronchus or Lung, Malignant Pleural Effusion, Hypertension, and Drug-Induced Agranulocytosis. Review of the physician order dated 2/23/2026, revealed “…SN [skilled nurse] 1wk [week] 1, 2wk8…” Review of the skilled nursing note dated 1/30/2026 documented the visit began on 1/23/2026 at 10:50 AM. Review of the Late Documentation Note documented the narrative was completed on 1/30/2026 at 10:28 PM. Review of the skilled nursing note dated 2/6/2026 documented the visit began on 1/31/2026. Review of the Late Documentation Note documented the narrative was completed on 2/6/2026 at 3:32 PM. Review of the skilled nursing note dated 2/10/2026 documented the visit began on 2/6/2026 at 4:20 PM. Review of the Late Documentation Note documented the narrative was completed on 2/10/2026 at 9:09 PM. Review of the medical record revealed Patient #5 was admitted to the agency on 3/13/2026, with diagnoses of Acute Kidney Failure, Diabetes Mellitus, Stage 5 Kidney Disease, Depression, and Dementia. Review of the physician order dated 2/23/2026, revealed “…SN [skilled nurse] 1 wk [week] 2; PT (physical therapy) effective 3/15/2026 1wk1, 2wk2,1wk5; and OT (occupational therapy) effective 3/15/2026 1wk1, 1every4wk4, 1wk1. Review of the skilled nursing note dated 3/15/2026 documented the visit began on 3/13/2026 at 4:05 PM. Review of the Late Documentation Note documented the narrative was completed on 3/15/2026 at 7:14 PM. Review of the medical record revealed Patient #7 was admitted to the agency on 3/11/2026, with diagnoses of Orthopedic Aftercare, Osteomyelitis of Cervical Vertebra, Extradural and Subdural Abscess, and Polyneuropathy. Review of the physician order dated 3/25/2026, revealed “…SN 1wk9; PT 1wk3; OT effective 3/15/2026 1 wk8; and ST 1 wk1. Review of the physical therapy note dated 3/15/2026 documented the visit began on 3/13/2026 at 11:23 AM. Review of the Late Documentation Note documented the narrative was completed on 3/15/226 at 3:34 PM. Review of the speech therapy note dated 3/15/2026 documented the visit began on 3/13/2026 at 3:39 PM. Review of the Late Documentation Note documented the narrative was completed on 3/15/226 at 9:19 PM. Review of the physical therapy note dated 3/23/2026 documented the visit began on 3/20/2026 at 9:29 AM. Review of the Late Documentation Note documented the narrative was completed on 3/23/226 at 7:28 AM. Review of the medical record revealed Patient #8 was admitted to the agency on 2/9/2026, with diagnoses of Infection of Left Lower Extremity Stump, Critical Illness Myopathy, Peripheral Vascular Disease, and Pyoderma Gangrenosum. Review of the physician order dated 2/9/2026, revealed “…SN effective 4/12/2026 1wk8…” Review of the skilled nursing note dated 2/16/2026 documented the visit began on 2/9/2026 at 3:37 PM. Review of the Late Documentation Note documented the narrative was completed on 2/16/2026 at 3:43 PM. Review of the skilled nursing note dated 2/23/2026 documented the visit began on 2/19/2026 at 12:30 PM. Review of the Late Documentation Note documented the narrative was completed on 2/23/2026 at 4:53 PM. Review of the skilled nursing note dated 3/4/2026 documented the visit began on 3/2/2026 at 11:57 AM. Review of the Late Documentation Note documented the narrative was completed on 3/4/2026 at 11:57 AM. Review of the skilled nursing note dated 3/5/2026 documented the visit began on 3/2/2026 at 4:08 PM. Review of the Late Documentation Note documented the narrative was completed on 3/5/2026 at 5:35 PM. Review of the skilled nursing note dated 3/9/2026 documented the visit began on 3/3/2026 at 10:00 AM. Review of the Late Documentation Note documented the narrative was completed on 3/9/2026 at 3:37 AM. Review of the skilled nursing note dated 3/16/2026 documented the visit began on 3/13/2026 at 1:50 PM. Review of the Late Documentation Note documented the narrative was completed on 3/16/2026 at 1:10 AM. Review of the skilled nursing note dated 3/30/2026 documented the visit began on 3/23/2026 at 1:28 PM. Review of the Late Documentation Note documented the narrative was completed on 3/30/2026 at 12:24 AM. Review of the skilled nursing note dated 4/1/2026 documented the visit began on 3/27/2026 at 12:46 PM. Review of the Late Documentation Note documented the narrative was completed on 3/30/2026 at 10:14 PM. Review of the skilled nursing note dated 4/1/2026 documented the visit began on 3/30/2026 at 12:32 PM. Review of the Late Documentation Note documented the narrative was completed on 4/1/2026 at 11:27 AM. Review of the medical record revealed Patient #9 was admitted to the agency on 3/1/2026, with diagnoses of Left Pubis Fracture, Hypertensive Urgency, Chronic Obstructive Pulmonary Disease, and Problems Related to Living Alone. Review of the physician order dated 3/1/2026, revealed “…SN 1wk4; PT 1wk9; OT 1wk1; and ST 1wk9…” Review of the occupational therapy note dated 3/6/2026 documented the visit began on 3/4/2026 at 9:53 AM. Review of the Late Documentation Note documented the narrative was completed on 3/6/2026 at 11:57 AM. Review of the speech therapy note dated 3/8/2026 documented the visit began on 3/5/2026 at 2:55 PM. Review of the Late Documentation Note documented the narrative was completed on 3/8/2026 at 10:11 PM. Review of the medical record revealed Patient #10 was admitted to the agency on 2/27/2026, with diagnoses of Stage 3 Sacral Pressure Ulcer, Right Upper Limb Cellulitis, Diabetes Mellitus, Hypertension, and Acute Kidney Failure. Review of the physician order dated 2/27/2026, revealed “…SN 1wk1, 2wk8; PT effective 3/1/2026 1wk5; MSW [social worker] effective 3/1/2026 1wk1, 1every2wk2…” Review of the skilled nursing note dated 3/2/2026 documented the visit began on 2/27/2026 at 11:48 AM. Review of the Late Documentation Note documented the narrative was completed on 3/2/2026 at 1:05 PM. Review of the skilled nursing note dated 3/3/2026 documented the visit began on 3/8/2026 at 9:16 AM. Review of the Late Documentation Note documented the narrative was completed on 3/8/2026 at 12:37 PM. Review of the skilled nursing note dated 3/11/2026 documented the visit began on 3/9/2026 at 4:10 PM. Review of the Late Documentation Note documented the narrative was completed on 3/11/2026 at 8:49 AM. Review of the skilled nursing note dated 3/17/2026 documented the visit began on 3/16/2026 at 10:02 AM. Review of the Late Documentation Note documented the narrative was completed on 3/17/2026 at 8:56 PM. Review of the skilled nursing note dated 3/20/2026 documented the visit began on 3/18/2026 at 3:38 PM. Review of the Late Documentation Note documented the narrative was completed on 3/20/2026 at 8:29 PM. Review of the skilled nursing note dated 4/1/2026 documented the visit began on 3/30/2026 at 12:42 PM. Review of the Late Documentation Note documented the narrative was completed on 4/1/2026 at 8:11 PM. Review of the skilled nursing note dated 4/9/2026 documented the visit began on 4/8/2026 at 3:50 PM. Review of the Late Documentation Note documented the narrative was completed on 4/9/2026 at 7:58 PM. Review of the skilled nursing note dated 4/15/2026 documented the visit began on 4/13/2026 at 10:48 AM. Review of the Late Documentation Note documented the narrative was completed on 4/15/2026 at 11:48 AM. Review of the skilled nursing note dated 4/17/2026 documented the visit began on 4/15/2026 at 5:47 PM. Review of the Late Documentation Note documented the narrative was completed on 4/17/2026 at 3:18 PM. Review of the medical record revealed Patient #11 was admitted to the agency on 1/8/2026, with diagnoses of Hemiplegia Following Cerebral Infarction, Polyneuropathy, Atherosclerotic Heart Disease, and Hypertension. Review of the physician order dated 3/9/2026, revealed “…SN 1wk1, 1every2wk8; PT 1wk5, 1every2wk4…” Review of the skilled nursing note dated 3/11/2026 documented the visit began on 3/10/2026 at 12:32 PM. Review of the Late Documentation Note documented the narrative was completed on 3/11/2026 at 12:19 PM. Review of the physical therapy note dated 3/12/2026 documented the visit began on 3/10/2026 at 12:45 PM. Review of the Late Documentation Note documented the narrative was completed on 3/12/2026 at 7:54 AM. During an interview on 4/22/2026 at 10:27 AM, the Area Vice President stated the clinical documentation should be summited within 24 hours.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on review of the Tennessee Code Annotated (TCA), policy review, record review, documentation review, and interviews, the agency failed to ensure that the Quality Assessment and Performance Improvement (QAPI) program focused on indicators related to improved outcomes, including the prevention and reduction of medical errors for 1 of 1 (Patient #1) reviewed. The findings included: Review of the Tennessee Code Annotated § 63-7-127, “Medication Aides” Copyright 2025, revealed, “...’medication aide’ means an individual who administers medications under the general supervision of a licensed registered or practical nurse...In exercising the authority to administer medications pursuant to a nursing delegation, a medication aide may administer medications in any of the following categories: Oral medications...Topical medications...A medication aide shall not: Administer medications when administration would require a dosage decision or calculation...A medication aide shall not, under any circumstances, administer medications by certain methods or routes, or both, as determined by rule. These methods or routes include, but are not limited to, the following...Subcutaneous...” Review of the agency’s policy “Administration and Documentation of Medications,” dated November of 2023, revealed, “…Non-licensed personnel may, with instruction, supervise and assist with self-administration of medication. Non-licensed personnel may document assisting the patient in his/her self-administration of medications…Non-licensed personnel will not administer medications…” Review of the agency’s policy “Improving Organizational Performance,” dated November of 2023, revealed, “…The organization will collect data on the following areas at a frequency identified by policy: Significant medication errors…All other organization personnel will…Be involved in performance improvement activities…” Review of the medical record revealed Patient #1 was admitted to the agency Start of Care (SOC) dated 9/3/2024, with diagnoses including Chronic Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Essential Hypertension, and Diabetes. Review of the Private Duty (PD) Admission Booklet revised July of 2020, revealed, “…SERVICES…A CNA [Certified Nursing Assistant] cannot...Prepare or administer medications…YOUR RIGHTS…QUALITY OF CARE- YOU HAVE THE RIGHT TO: Receive high quality, appropriate care…in accordance with physician orders…” Review of the Personnel File revealed the Certified Nursing Assistant (CNA #1) was employed with the agency from 10/25/2023 to 11/22/2024 as a private duty aide. Review of the New Hire Packet dated 10/25/2023, revealed, “…Job Description:..Providing hands-on personal care including Baths, Oral Hygiene, Shampoos…and other duties within their scope of practice assigned by supervising clinician…Assisting patients in the self-administration of medication…” Review of the Home Health Aide Competency Evaluation dated 10/26/2023, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of on-line training from 5/13/2024-9/6/2024, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of the Visit Note Report dated 9/3/2024, revealed, “…RN OASIS ADMISSION PRIVATE DUTY…DIABETES…IS CLIENT TAKING INSULIN? YES. HOW FREQUENT ARE BLOOD SUGARS CHECKED…DAILY AND AS NEEDED…CAN THE PATIENT SELF INJECT INJECTABLE MEDICATION (I.E., INSULIN…)? YES…INDICATE CLIENT’S KNOWLEDGE BASE DEFICITS…MEDICATIONS…DRUG REGIMINE REVIEW: DID A COMPLETE DRUG REGIMEN REVIEW IDENTIFIY POTENTIAL CLINICALLY SIGNIFICANT MEDICATION ISSUES?...NO-NO ISSUES FOUND DURING REVIEW…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF THE CORRECT DOSAGE AT THE APPROPROIATE TIMES/INTERVALS…NA-NO INJECTABLE MEDICATIONS PRESCRIBED…HIGH-RISK DRUG CLASSES USE AND INDICATION: CHECK IF THE PATIENT IS TAKING ANY MEDICATIONS BY PHARMACOLOGICAL CLASSIFICATION…HYPOGLYCEMIC (INCLUDING) INSULIN…GOALS NOT MET…PATIENT/ CAREGIVER DEMONSTRATES SAFE, APPROPRIATE USE OF MEDICATIONS EXCEPTION CODE: ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…MEDICATION UNDERSTANDING CHANGES…[Named insulin lispro pen] [a disposable, pre-filled, insulin pen with 100 units of fast-acting insulin used to treat high blood sugar. The patient is able to rotate the dose knob in order to administer the correct dose] (U-100) INSULIN 100 UNIT/ ML [milliliter] SUBCUTANEOUS…” Review of the Private Duty Plan of Care (PDPOC) certification period from 9/3/2024-11/1/2024, revealed Skilled Nursing (SN) services were ordered once a week for one week and once every 4 weeks for eight weeks to evaluate and develop the plan of care, assess/evaluate co-morbidities, to identify changes, and intervene to minimize complications. SN was to perform management and evaluation to observe and assess underlying conditions, complications, and effects of the non-skilled care on the patient’s overall wellbeing. The SN was to develop, manage, and revise the non-skilled plan of care based on the registered nurses’ (RN’s) assessment. Home Health Aide (HHA) services were ordered 4 times a week for 1 week and 5 times a week for 8 weeks for assistance with personal care and activities of daily living (ADLs) secondary to functional limitations which prevent self-care.; and private duty certified nursing assistant (PDCNA) services ordered for 25 hours a week for 9 weeks. Medications- insulin lispro pen 100 units/ milliliter (ml) subcutaneously, three times daily. There were no skilled or non-skilled services ordered to assist or administer Patient #1’s insulin. Review of CNA #1’s Visit Note Report revealed the following: 10/1/2024 at 8:08 AM-Staff helped Patient #1 with insulin, but Patient #1 self-injected. 10/2/2024 at 7:56 AM- Patient #1 took medications. Helped Patient #1 with insulin. 12:56 AM- Helped Patient #1 with insulin. 10/4/2024 at 7:41 AM- Patient #1 took medications. Helped Patient #1 with insulin. 10/7/2024 at 7:50 AM- Helped Patient #1 with insulin. 10/8/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin 10/9/2024 at 7:50 AM- Staff helped Patient #1 with insulin. 12:50 PM- Staff helped Patient #1 with insulin. 10/11/2024 at 9:55 AM- Helped Patient #1 with insulin. 1:55 PM- Staff helped Patient #1 with insulin. 10/14/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin. 10/15/2024 at 8:09 AM- Staff helped Patient #1 with insulin. 9:35 AM- Pt needed more insulin. Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1with insulin. 10/18/2024 at 9:54 AM- Helped Patient #1 with insulin. 10:54 AM- Helped Patient #1 with insulin. 10/21/2024 at 9:01 AM- Helped Patient #1 with insulin. 11:01 AM- Helped Patient #1 with insulin. 1:01 PM- Staff helped Patient #1 with insulin. 2:01 PM- Helped Patient #1 with insulin. 10/23/2024 at 8:20 AM- Staff helped Patient #1with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/25/2024 at 8:20 AM- Staff helped Patient #1 with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/30/2024 at 8:21 AM- Patient #1 had already taken medications. Staff Patient #1 patient with insulin. 1:31 PM- Staff helped Patient #1 with insulin. 11/1/2024 at 8:01 AM- Patient #1 took medications while sitting in the living room. Staff helped Patient #1 with insulin, but Patient #1 self-injected. 11/2/2024 at 6:22 AM- Helped Patient #1 with insulin. 11:22 PM- Helped Patient #1 with insulin. 11/4/2024 at 9:15 AM- Helped Patient #1 with insulin. 12:57 PM Staff helped Patient #1 with insulin. 11/5/2024 at 9:15 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 12:00 PM- Nurse came. 12:38 PM- Nurse left. 1:00 PM- Helped Patient #1 with insulin. 11/6/2024 at 9:00 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 1:00 PM- Helped Patient #1 with insulin. 11/11/2024 at 7:50 AM- Staff checked patient’s vital signs and helped Patient #1 with insulin. 11/12/2024 at 7:31 AM- Staff helped Patient #1 with insulin. 12:31 PM- Staff helped Patient #1 with insulin. 11/15/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 10:00 AM- Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1 with insulin. 11/18/2024 at 8:57 AM- Staff helped Patient #1 with insulin. 10:57 AM- Helped Patient #1 with insulin. 12:57 PM- Staff helped Patient #1 with insulin. 1:57 PM- Helped Patient #1 with insulin. 11/19/2024 at 7:53 AM- Staff helped Patient #1 with insulin. 9:45 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/20/2024 at 7:53 AM- Helped Patient #1 with insulin. 9:55 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/22/2024 at 7:55 AM- “…Patient asked staff some questions on my job description on giving insulin. I called bosses to find out…1355 Leaving PT [patient] in care of self…” Review of the Visit Note Report dated 10/29/2024, revealed, “…RN RECERT [recertification] WITH SKILL [skilled nursing] PRIVATE DUTY…MEDICATIONS…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF CORRECT DOSAGE AT THE APPROPRIATE TIMES/ INTERVALS…ABLE TO INDEPENDENTLY TAKE THE CORRECT MEDICATION(S) AND PROPER DOSAGE AT THE CORRECT TIMES…WERE SUPERVISORY FUNCTIONS PERFORMED? YES. INDICATE DISCIPLINE OF EMPLOYEE BEING EVALUATED: HOME HEALTH AIDE. AIDE NOT PRESENT…INDICATE NAME OF HOME HEALTH AIDE BEING EVALUATED…[Named CNA #1]. AIDE FOLLOWS PLAN OF CARE/ ASSIGNED TASKS…YES…ARE THE INSULIN ADMINISTRATION ORDERS BEING FOLLOWED? YES…IS THE CLIENT/ CAREGIVER INDEPENDENT WITH BLOOD SUGAR ANALYSIS? NO. IS THE CLIENT/CAREGIVER INDEPENDENT WITH INJECTABLE MEDICATION ADMINISTRATION…CHANGES NEEDED TO SERVICES PROVIDED…NO CHANGES IN FREQUENCY/ DURATION, MEDICATIONS, OR TREATMENT…PLAN FOR NEXT VISIT…PD [private duty] RECERT VISIT COMPLETED BY SN…PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…GOALS NOT MET…NON-SKILLED PLAN OF CARE WILL BE EVALUATED WITH APPROPRIATE INTERVENTIONS AND COORDINATION OF CARE TO MAINTAIN PATIENT IN A SAFE ENVIRONMENT WITHOUT EXACERBATIONS OF DISEASE PROCESS…ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…” There were no orders to assist or administer Ms. Gilliam’s insulin, and the services received were not consistent with Patient #1’s plan of care; however, the Visit note for 10/29/2024, revealed documentation that CNA #1 was following the plan of care. Review of the Client Coordination Note Report revealed the following: 10/1/2024- “…PD [private duty] SUP [supervisory] VISIT COMPLETED BY SN…PT [patient] IS A DIABETIC AND STATES SHE DOES NOT CHECK HER SUGAR BUT GIVES INSULIN. EDUCATED ON IMPORTANCE OF MONITORING BLOOD GLUCOSE TO PREVENT HYPOGLYCEMIC EPISODE…” Entered by RN #1 10/29/2024- “…RN RECERT SUP VISIT COMPLETED BY SN...PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…” Entered by RN #1 11/26/2024- “…MEDICATION ERROR IDENTIFIED. CNA DREW UP AND ADMINISTERED INSULIN ACTING OUTSIDE THEIR SCOPE OF PRACTICE. PATIENT CONTACTED REGARDING THIS. PT STATED CAN HELPED HER BECAUSE SHE WAS HAVING DIFFICULTY GIVING HERSELF INJECTION IN HER ARM. HOME HEALTH NOTIFIED OF PATIENT NEEDING ADDITIONAL EDUCATION ON INSULIN…” Entered by LPN #1 11/26/2024- “…EMAIL SENT TO HH REGARDING NEED FOR ADDITIONAL TEACHING ON INSULIN ADMINISTRATION. HH TO NOTIFY NURSE SCHEDULED TO SEE PATIENT THIS WEEK…” Entered by LPN #1 Review of the Details of the Complaint undated, revealed on 11/22/2024, CNA #1 called LPN #1 (her supervisor) to ask if she was permitted to draw up insulin in a syringe to administer to her patients because one of CNA #1’s patients had questioned her, “...as she has been doing this and wondered if it was within her job duties...” LPN #1 instructed CNA #1 that it was not within the CNA’s scope of practice, and she needed to stop immediately. LPN #1 placed CNA #1 on suspension pending investigation. On 11/25/2024, LPN #1 spoke with CNA #1 further, and she admitted that she had been helping Patient #1 draw up the insulin because Patient #1 had an abdominal hernia (an abnormal protrusion of tissue or an organ through the abdominal wall) and struggled to administer her insulin in her arm. Patient #1 tried to inject the insulin in her arm, but her hands shook. Review of CNA #1’s written statement dated 11/25/2024 revealed, “…PT [patient] got insulin. PT would draw it up in the needle and would put needle in and most of the time push it in. Some days[,] I would help push it in due to pt hands shaking and couldn’t grip it…I only helped when [her] hand would shake[,] and she would have trouble…Staff would squeeze arm for Pt [patient] and Pt would pt [put] needled in arm…There where [were] times that I did draw up the number that the pt would tell me to draw up…” Review of the Separation Notice dated 11/26/2024, revealed CNA #1 was discharged for violation of company policy. Review of the Quality Assessment Performance Improvement (QAPI) Minutes dated 1/21/2024 and 2/18/2025, revealed no documentation of any discussion involving CNA #1 providing medication assistance or CNA #1 administering medications. The agency provided no documentation that CNA #1’s charting was reviewed, and the facility provided not documentation that they reached out to CNA #1’s other patients to identify if there were any other instances of medication administration. The agency provided no documentation that any policy or medication training was conducted after the event(s) was identified. During an interview on 3/5/2025 at 12:25 PM, The Private Duty Executive Director (PDED) confirmed there were no orders to assist Patient #1 with medications, and medications assistance was not outlined in the plan of care. She said that CNAs could assist the patient with medications by handing the patient their pill planner and remind them to take their medications, but they were not allowed to administer medication. The PDED said the CNAs cannot even touch the medications, and they do not under any circumstances even allow CNAs who are medication certified to administer medications. The PDED stated that there was a 24 hour on-call service, and there was no reason that CNA #1 could not have been supported. She said that CNA #1 should have called for direction before administering medication. The PDED said that PD used the home health nursing staff to perform supervisory visits, and they try to perform the visits every 30 days. She said that when conducting a supervisory visit, the registered nurse (RN) should perform a quick assessment to ensure the patient’s needs are met and the patient is pleased with their service. When asked if the RN is supposed to review the CNA’s visit notes, she said the RN can, but that fell on the private duty office. The PDED said that the event was reported as a medication error and verified that there was no documentation of medication training or discussion of CNA #1 administering insulin recorded on the QAPI meeting minutes. The PDED stated the PD office did not catch CNA #1’s documentation that she was assisting Patient #1 with her medications until after CNA #1 contacted the office about medication administration. During a phone interview on 3/5/2024 at 1:10 PM, LPN #1, the Clinical Services Manager reported that CNA #1 called the office and asked the scheduler, CNA #2 if she was allowed to administer insulin. She stated that CNA #1 did not administer the insulin the day she contacted the office, the event took place prior to that day. She said CNA #2 contacted the care coordinator, and the coordinator sent email to LPN #1 to let her know what had occurred. LPN #1 said she contacted CNA #1, and she spoke with the patient. She said that CNA #1 had been helping Patient #1 with her insulin, and CNA #1 administered insulin in Patient #1’s arm because Patient #1 had not been able to self-administer the medication. LPN #1 said Patient #1 had a hard time reaching her arm, and she was instructed not to administer her insulin in her stomach because of hernia. LPN #1 said that she explained to CNA #1 that insulin administration was out of her scope of practice. She said CNA #1 knew she was not supposed to administer medications, but she was just trying to help, and she was not thinking. LPN #1 said she emailed to the PDED about process and reached out to Human Resources (HR) Compliance. LPN #1 said that she spoke with Patient #1 several times, and she went back and forth on the issue. She stated that Patient #1 told her CNA #1 drew up insulin, and Patient #1 administered it. LPN #1 stated that she documented talking to Patient #1 and told her that she could administer her own insulin in the top of her thigh. LPN #1 said she reached out to the home health administrator to do more teaching with the patient. She stated the agency reported the incident to (Named State Agency that administers Medicaid) and sent everything she had written to corporate. LPN #1 said that she pulled CNA #1 from the schedule until the facility investigation was completed. She said that Patient #1 was CNA #1’s main patient. LPN #1 stated that she called one of CNA #1’s other patients and looked back at documentation. She stated that she did not identify anything that indicated she had administered medication to any other patients. LPN #1 said that she asked CNA #1 if she had administered insulin to only one patient, but she could not recall CNA #1’s response. During a phone interview on 3/5/2025 at 3:40 PM, the scheduler, CNA #2 reported that CNA #1 called her and stated that she gave insulin to Patient #1. CNA #2 said that she told CNA #1 that she was not allowed to give medications and reported it to LPN #1. CNA #2 said that CNAs were not allowed to administer any medication at all. She stated that CNAs were only allowed to remind patients to take their medications. CNA #2 stated that CNAs were also to remind patients that CNAs were not allowed to administer insulin. She said that she never received any complaints from Patient #1 before the incident, but once they learned that CNA #1 had administered insulin, Patient #1 made it known that she had issues. She stated that Patient #1 was covering for CNA #1 because she did not want to get her in trouble. During a phone interview on 3/10/2025 at 1:10 PM, CNA #1 stated that she guided Patient #1’s hand to her arm because her hand shook. She said that Patient #1 did it herself. She said Patient #1 stuck the needle in and pushed the plunger. When CNA #1 was asked if she ever drew up Ms. Patient #1 insulin, CNA #1 replied, “No ma’am.” CNA #1 said that Patient #1 was the first and only patient she assisted, and CNA #1 provided a statement to the agency.”

“Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This Standard is not met as evidenced by: Based on review of the Tennessee Code Annotated (TCA), policy review, record review, documentation review, and interviews, the agency failed to ensure appropriate nursing supervision of a certified nursing assistant (CNA #1) when CNA #1 provided services that were not ordered by the physician, not in accordance with the patients plan of care (POC), and out of the CNA’s scope of practice for 1 of 1 (Patient #1) patient reviewed. The findings included: Review of the Tenn. Code Ann. § 63-7-127, “Medication Aides” Copyright 2025, revealed, “...’medication aide’ means an individual who administers medications under the general supervision of a licensed registered or practical nurse...In exercising the authority to administer medications pursuant to a nursing delegation, a medication aide may administer medications in any of the following categories: Oral medications...Topical medications...A medication aide shall not: Administer medications when administration would require a dosage decision or calculation...A medication aide shall not, under any circumstances, administer medications by certain methods or routes, or both, as determined by rule. These methods or routes include, but are not limited to, the following...Subcutaneous...” Review of the agency’s policy “Administration and Documentation of Medications,” dated November of 2023, revealed, “…Non-licensed personnel may, with instruction, supervise and assist with self-administration of medication. Non-licensed personnel may document assisting the patient in his/her self-administration of medications…Non-licensed personnel will not administer medications…” Review of the medical record revealed Patient #1 was admitted to the agency Start of Care (SOC) dated 9/3/2024, with diagnoses including Chronic Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Essential Hypertension, and Diabetes. Review of the Private Duty (PD) Admission Booklet revised July of 2020, revealed, “…SERVICES…A CNA [Certified Nursing Assistant] cannot...Prepare or administer medications…YOUR RIGHTS…QUALITY OF CARE- YOU HAVE THE RIGHT TO: Receive high quality, appropriate care…in accordance with physician orders…” Review of the Personnel File revealed the Certified Nursing Assistant (CNA #1) was employed with the agency from 10/25/2023 to 11/22/2024 as a private duty aide. Review of the New Hire Packet dated 10/25/2023, revealed, “…Job Description:..Providing hands-on personal care including Baths, Oral Hygiene, Shampoos…and other duties within their scope of practice assigned by supervising clinician…Assisting patients in the self-administration of medication…” Review of the Home Health Aide Competency Evaluation dated 10/26/2023, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of on-line training from 5/13/2024-9/6/2024, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of the Visit Note Report dated 9/3/2024, revealed, “…RN OASIS ADMISSION PRIVATE DUTY…DIABETES…IS CLIENT TAKING INSULIN? YES. HOW FREQUENT ARE BLOOD SUGARS CHECKED…DAILY AND AS NEEDED…CAN THE PATIENT SELF INJECT INJECTABLE MEDICATION (I.E., INSULIN…)? YES…INDICATE CLIENT’S KNOWLEDGE BASE DEFICITS…MEDICATIONS…DRUG REGIMINE REVIEW: DID A COMPLETE DRUG REGIMEN REVIEW IDENTIFIY POTENTIAL CLINICALLY SIGNIFICANT MEDICATION ISSUES?...NO-NO ISSUES FOUND DURING REVIEW…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF THE CORRECT DOSAGE AT THE APPROPROIATE TIMES/INTERVALS…NA-NO INJECTABLE MEDICATIONS PRESCRIBED…HIGH-RISK DRUG CLASSES USE AND INDICATION: CHECK IF THE PATIENT IS TAKING ANY MEDICATIONS BY PHARMACOLOGICAL CLASSIFICATION…HYPOGLYCEMIC (INCLUDING) INSULIN…GOALS NOT MET…PATIENT/ CAREGIVER DEMONSTRATES SAFE, APPROPRIATE USE OF MEDICATIONS EXCEPTION CODE: ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…MEDICATION UNDERSTANDING CHANGES…[Named insulin lispro pen] [a disposable, pre-filled, insulin pen with 100 units of fast-acting insulin used to treat high blood sugar. The patient is able to rotate the dose knob in order to administer the correct dose] (U-100) INSULIN 100 UNIT/ ML [milliliter] SUBCUTANEOUS…” The Visit Note indicated that Patient #1 was able to self-inject using the prescribed insulin lispro pen, and a medication knowledge deficit was documented. However, it was documented that no injectable medications were prescribed, and no clinically significant medication issues were identified during the drug regimen review. Review of the Private Duty Plan of Care (PDPOC) certification period from 9/3/2024-11/1/2024, revealed Skilled Nursing (SN) services were ordered once a week for one week and once every 4 weeks for eight weeks to evaluate and develop the plan of care, assess/evaluate co-morbidities, to identify changes, and intervene to minimize complications. SN was to perform management and evaluation to observe and assess underlying conditions, complications, and effects of the non-skilled care on the patient’s overall wellbeing. The SN was to develop, manage, and revise the non-skilled plan of care based on the registered nurses’ (RN’s) assessment. Home Health Aide (HHA) services were ordered 4 times a week for 1 week and 5 times a week for 8 weeks for assistance with personal care and activities of daily living (ADLs) secondary to functional limitations which prevent self-care.; and private duty certified nursing assistant (PDCNA) services ordered for 25 hours a week for 9 weeks. Medications- insulin lispro pen 100 units/ milliliter (ml) subcutaneously, three times daily. Review of CNA #1’s Visit Note Report revealed the following: 10/1/2024 at 8:08 AM-Staff helped Patient #1 with insulin, but Patient #1 self-injected. 10/2/2024 at 7:56 AM- Patient #1 took medications. Helped Patient #1 with insulin. 12:56 AM- Helped Patient #1 with insulin. 10/4/2024 at 7:41 AM- Patient #1 took medications. Helped Patient #1 with insulin. 10/7/2024 at 7:50 AM- Helped Patient #1 with insulin. 10/8/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin 10/9/2024 at 7:50 AM- Staff helped Patient #1 with insulin. 12:50 PM- Staff helped Patient #1 with insulin. 10/11/2024 at 9:55 AM- Helped Patient #1 with insulin. 1:55 PM- Staff helped Patient #1 with insulin. 10/14/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin. 10/15/2024 at 8:09 AM- Staff helped Patient #1 with insulin. 9:35 AM- Pt needed more insulin. Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1with insulin. 10/18/2024 at 9:54 AM- Helped Patient #1 with insulin. 10:54 AM- Helped Patient #1 with insulin. 10/21/2024 at 9:01 AM- Helped Patient #1 with insulin. 11:01 AM- Helped Patient #1 with insulin. 1:01 PM- Staff helped Patient #1 with insulin. 2:01 PM- Helped Patient #1 with insulin. 10/23/2024 at 8:20 AM- Staff helped Patient #1with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/25/2024 at 8:20 AM- Staff helped Patient #1 with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/30/2024 at 8:21 AM- Patient #1 had already taken medications. Staff Patient #1 patient with insulin. 1:31 PM- Staff helped Patient #1 with insulin. 11/1/2024 at 8:01 AM- Patient #1 took medications while sitting in the living room. Staff helped Patient #1 with insulin, but Patient #1 self-injected. 11/2/2024 at 6:22 AM- Helped Patient #1 with insulin. 11:22 PM- Helped Patient #1 with insulin. 11/4/2024 at 9:15 AM- Helped Patient #1 with insulin. 12:57 PM Staff helped Patient #1 with insulin. 11/5/2024 at 9:15 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 12:00 PM- Nurse came. 12:38 PM- Nurse left. 1:00 PM- Helped Patient #1 with insulin. 11/6/2024 at 9:00 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 1:00 PM- Helped Patient #1 with insulin. 11/11/2024 at 7:50 AM- Staff checked patient’s vital signs and helped Patient #1 with insulin. 11/12/2024 at 7:31 AM- Staff helped Patient #1 with insulin. 12:31 PM- Staff helped Patient #1 with insulin. 11/15/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 10:00 AM- Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1 with insulin. 11/18/2024 at 8:57 AM- Staff helped Patient #1 with insulin. 10:57 AM- Helped Patient #1 with insulin. 12:57 PM- Staff helped Patient #1 with insulin. 1:57 PM- Helped Patient #1 with insulin. 11/19/2024 at 7:53 AM- Staff helped Patient #1 with insulin. 9:45 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/20/2024 at 7:53 AM- Helped Patient #1 with insulin. 9:55 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/22/2024 at 7:55 AM- “…Patient asked staff some questions on my job description on giving insulin. I called bosses to find out…1355 Leaving PT [patient] in care of self…” Review of the Visit Note Report dated 10/29/2024, revealed, “…RN RECERT WITH SKILL PRIVATE DUTY…MEDICATIONS…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF CORRECT DOSAGE AT THE APPROPRIATE TIMES/ INTERVALS…ABLE TO INDEPENDENTLY TAKE THE CORRECT MEDICATION(S) AND PROPER DOSAGE AT THE CORRECT TIMES…WERE SUPERVISORY FUNCTIONS PERFORMED? YES. INDICATE DISCIPLINE OF EMPLOYEE BEING EVALUATED: HOME HEALTH AIDE. AIDE NOT PRESENT…INDICATE NAME OF HOME HEALTH AIDE BEING EVALUATED…[Named CNA #1]. AIDE FOLLOWS PLAN OF CARE/ ASSIGNED TASKS…YES…ARE THE INSULIN ADMINISTRATION ORDERS BEING FOLLOWED? YES…IS THE CLIENT/ CAREGIVER INDEPENDENT WITH BLOOD SUGAR ANALYSIS? NO. IS THE CLIENT/CAREGIVER INDEPENDENT WITH INJECTABLE MEDICATION ADMINISTRATION…CHANGES NEEDED TO SERVICES PROVIDED…NO CHANGES IN FREQUENCY/ DURATION, MEDICATIONS, OR TREATMENT…PLAN FOR NEXT VISIT…PD [private duty] RECERT VISIT COMPLETED BY SN…PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…GOALS NOT MET…NON-SKILLED PLAN OF CARE WILL BE EVALUATED WITH APPROPRIATE INTERVENTIONS AND COORDINATION OF CARE TO MAINTAIN PATIENT IN A SAFE ENVIRONMENT WITHOUT EXACERBATIONS OF DISEASE PROCESS…ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…” Review of the Client Coordination Note Report revealed the following: 10/1/2024- “…PD [private duty] SUP [supervisory] VISIT COMPLETED BY SN…PT [patient] IS A DIABETIC AND STATES SHE DOES NOT CHECK HER SUGAR BUT GIVES INSULIN. EDUCATED ON IMPORTANCE OF MONITORING BLOOD GLUCOSE TO PREVENT HYPOGLYCEMIC EPISODE…” Entered by RN #1 10/29/2024- “…RN RECERT SUP VISIT COMPLETED BY SN...PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…” Entered by RN #1 11/26/2024- “…MEDICATION ERROR IDENTIFIED. CNA DREW UP AND ADMINISTERED INSULIN ACTING OUTSIDE THEIR SCOPE OF PRACTICE. PATIENT CONTACTED REGARDING THIS. PT STATED CAN HELPED HER BECAUSE SHE WAS HAVING DIFFICULTY GIVING HERSELF INJECTION IN HER ARM. HOME HEALTH NOTIFIED OF PATIENT NEEDING ADDITIONAL EDUCATION ON INSULIN…” Entered by LPN #1. 11/26/2024- “…EMAIL SENT TO HH REGARDING NEED FOR ADDITIONAL TEACHING ON INSULIN ADMINISTRATION. HH TO NOTIFY NURSE SCHEDULED TO SEE PATIENT THIS WEEK…” Entered by LPN #1 Review of the Details of the Complaint undated, revealed on 11/22/2024, CNA #1 called LPN #1 (her supervisor) to ask if she was permitted to draw up insulin in syringes to administer to patients because one of CNA #1’s patients had questioned her “...as she has been doing this and wondered if it was within her job duties...” LPN #1 instructed CNA #1 that it was not within the CNA’s scope of practice, and she needed to stop immediately. LPN #1 placed CNA #1 on suspension pending investigation. On 11/25/2024, LPN #1 spoke with CNA #1 further, and she admitted that she had been helping Patient #1 draw up the insulin because Patient #1 had an abdominal hernia (an abnormal protrusion of tissue or organ through the abdominal wall) and struggled to administer her insulin in her arm. Patient #1 tried to inject the insulin in her arm, but her hands shook. Review on CNA #1’s written statement dated 11/25/2024 revealed, “…PT [patient] got insulin. PT would draw it up in the needle and would put needle in and most of the time push it in. Some days[,] I would help push it in due to pt hands shaking and couldn’t grip it…I only helped when [her] hand would shake[,] and she would have trouble…Staff would squeeze arm for Pt [patient] and Pt would pt [put] needled in arm…There where [were] times that I did draw up the number that the pt would tell me to draw up…” Review of the Separation Notice dated 11/26/2024, revealed CNA #1 was discharged for violation of company policy. There were no orders to assist or administer Patient #1’s insulin, and the services received were not consistent with Patient #1’s plan of care; however, the Visit note for 10/29/2024, revealed documentation that CNA #1 was following the plan of care. During an interview on 3/5/2025 at 12:25 PM, The Private Duty Executive Director (PDED) confirmed there were no orders to assist Patient #1 with medications, and medications assistance was not outlined in the plan of care. She said that CNAs could assist the patient with medications by handing the patient their pill planner and remind them to take their medications, but they were not allowed to administer medication. The PDED said the CNAs cannot even touch the medications, and they do not under any circumstances even allow CNAs who are medication certified to administer medications. The PDED stated that there was a 24 hour on-call service, and there was no reason that CNA #1 could not have been supported. She said that CNA #1 should have called for direction before administering medication. The PDED said that PD used the home health nursing staff to perform supervisory visits, and they try to perform the visits every 30 days. She said that when conducting a supervisory visit, the registered nurse (RN) should perform a quick assessment to ensure the patient’s needs are met and the patient is pleased with their service. When asked if the RN is supposed to review the CNA’s visit notes, she said the RN can, but that fell on the private duty office. The PDED said that the event was reported as a medication error and verified that there was no documentation of any medication training The PDED stated the PD office did not catch CNA #1’s documentation that she was assisting Patient #1 with her medications until after CNA #1 contacted the office. During a phone interview on 3/5/2024 at 1:10 PM, LPN #1, the Clinical Services Manager, reported that CNA #1 called the office and asked the scheduler, CNA #2 if she was allowed to administer insulin. She stated that CNA #1 did not administer the insulin the day she contacted the office, the event took place prior to that day. She said CNA #2 contacted the care coordinator, and the coordinator sent email to LPN #1 to let her know what had occurred. LPN #1 said she contacted CNA #1, and she spoke with the patient. She said that CNA #1 had been helping Patient #1 with her insulin, and CNA #1 administered insulin in Patient #1’s arm because Patient #1 had not been able to self-administer the medication. LPN #1 said Patient #1 had a hard time reaching her arm, and she was instructed not to administer her insulin in her stomach because of hernia. LPN #1 said that she explained to CNA #1 that insulin administration was out of her scope of practice. She said CNA #1 knew she was not supposed to administer medications, but she was just trying to help, and she was not thinking. LPN #1 said that she spoke with Patient #1 several times, and Patient #1 told her that CNA #1 drew up insulin, and Patient #1 administered it. LPN #1 stated that she told Patient #1 that she could administer her own insulin in the top of her thigh. LPN #1 said that Patient #1 was agreeable to self-administering her insulin in her thigh, and LPN #1 reached out to the home health administrator to do more teaching with the patient. LPN #1 said that she pulled CNA #1 from the schedule until the facility investigation was completed. She said that Patient #1 was CNA #1’s main patient. LPN #1 stated that she called one of CNA #1’s other patients and looked back at documentation. She stated that she did not identify anything that indicated she had administered medication to any other patients. LPN #1 said that she asked CNA #1 if she had administered insulin to only one patient, but she could not recall CNA #1’s response. During a phone interview on 3/5/2025 at 3:40 PM, the scheduler, CNA #2 reported that CNA #1 called her and stated that she gave insulin to Patient #1. CNA #2 said that she told CNA #1 that she was not allowed to give medications and reported it to LPN #1. CNA #2 said that CNAs were not allowed to administer any medication at all. She stated that CNAs were only allowed to remind patients to take their medications. CNA #2 stated that CNAs were also to remind patients that CNAs were not allowed to administer insulin. She said that she never received any complaints from Patient #1 before the incident, but once they learned that CNA #1 had administered insulin, Patient #1 made it known that she had issues. She stated that Patient #1 was covering for CNA #1 because she did not want to get her in trouble. During a phone interview on 3/10/2025 at 1:10 PM, CNA #1 stated that she guided Patient #1’s hand to her arm because her hand shook. She said that Patient #1 did it herself. She said Patient #1 stuck the needle in and pushed the plunger. When CNA #1 was asked if she ever drew up Ms. Patient #1 insulin, CNA #1 replied, “No ma’am.” CNA #1 said that Patient #1 was the first and only patient she assisted, and CNA #1 provided a statement to the agency.”

“Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient’s representative (if any), and the patient’s caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This Element is not met as evidenced by: Based on review of the Tennessee Code Annotated (TCA), policy review, record review, documentation review, and interviews, the facility failed to ensure a patient’s rights by conducting a thorough investigation surrounding an incident(s) of medication administration by unlicensed personnel when a certified nursing assistant (CNA #1) acted out of her scope of practice for 1 of 1 (Patient #1) patient reviewed. The findings included: Review of the Tennessee Code Annotated § 63-7-127, “Medication Aides” Copyright 2025, revealed, “...’medication aide’ means an individual who administers medications under the general supervision of a licensed registered or practical nurse...In exercising the authority to administer medications pursuant to a nursing delegation, a medication aide may administer medications in any of the following categories: Oral medications...Topical medications...A medication aide shall not: Administer medications when administration would require a dosage decision or calculation...A medication aide shall not, under any circumstances, administer medications by certain methods or routes, or both, as determined by rule. These methods or routes include, but are not limited to, the following...Subcutaneous...” Review of the agency’s policy “Administration and Documentation of Medications,” dated November of 2023, revealed, “…Non-licensed personnel may, with instruction, supervise and assist with self-administration of medication. Non-licensed personnel may document assisting the patient in his/her self-administration of medications…Non-licensed personnel will not administer medications…” Review of the agency’s policy “Improving Organizational Performance,” dated November of 2023, revealed, “…The organization will collect data on the following areas at a frequency identified by policy: Significant medication errors…All other organization personnel will…Be involved in performance improvement activities…” Review of the medical record revealed Patient #1 was admitted to the agency Start of Care (SOC) dated 9/3/2024, with diagnoses including Chronic Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Essential Hypertension, and Diabetes. Review of the Private Duty (PD) Admission Booklet revised July of 2020, revealed, “…SERVICES…A CNA [Certified Nursing Assistant] cannot...Prepare or administer medications…YOUR RIGHTS…QUALITY OF CARE- YOU HAVE THE RIGHT TO: Receive high quality, appropriate care…in accordance with physician orders…” Review of the Personnel File revealed the Certified Nursing Assistant (CNA #1) was employed with the agency from 10/25/2023 to 11/22/2024 as a private duty aide. Review of the New Hire Packet dated 10/25/2023, revealed, “…Job Description:..Providing hands-on personal care including Baths, Oral Hygiene, Shampoos…and other duties within their scope of practice assigned by supervising clinician…Assisting patients in the self-administration of medication…” Review of the Home Health Aide Competency Evaluation dated 10/26/2023, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of on-line training from 5/13/2024-9/6/2024, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of the Visit Note Report dated 9/3/2024, revealed, “…RN OASIS ADMISSION PRIVATE DUTY…DIABETES…IS CLIENT TAKING INSULIN? YES. HOW FREQUENT ARE BLOOD SUGARS CHECKED…DAILY AND AS NEEDED…CAN THE PATIENT SELF INJECT INJECTABLE MEDICATION (I.E., INSULIN…)? YES…INDICATE CLIENT’S KNOWLEDGE BASE DEFICITS…MEDICATIONS…DRUG REGIMINE REVIEW: DID A COMPLETE DRUG REGIMEN REVIEW IDENTIFIY POTENTIAL CLINICALLY SIGNIFICANT MEDICATION ISSUES?...NO-NO ISSUES FOUND DURING REVIEW…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF THE CORRECT DOSAGE AT THE APPROPROIATE TIMES/INTERVALS…NA-NO INJECTABLE MEDICATIONS PRESCRIBED…HIGH-RISK DRUG CLASSES USE AND INDICATION: CHECK IF THE PATIENT IS TAKING ANY MEDICATIONS BY PHARMACOLOGICAL CLASSIFICATION…HYPOGLYCEMIC (INCLUDING) INSULIN…GOALS NOT MET…PATIENT/ CAREGIVER DEMONSTRATES SAFE, APPROPRIATE USE OF MEDICATIONS EXCEPTION CODE: ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…MEDICATION UNDERSTANDING CHANGES…[Named insulin lispro pen] [a disposable, pre-filled, insulin pen with 100 units of fast-acting insulin used to treat high blood sugar. The patient is able to rotate the dose knob in order to administer the correct dose] (U-100) INSULIN 100 UNIT/ ML [milliliter] SUBCUTANEOUS…” Review of the Private Duty Plan of Care (PDPOC) certification period from 9/3/2024-11/1/2024, revealed Skilled Nursing (SN) services were ordered once a week for one week and once every 4 weeks for eight weeks to evaluate and develop the plan of care, assess/evaluate co-morbidities, to identify changes, and intervene to minimize complications. SN was to perform management and evaluation to observe and assess underlying conditions, complications, and effects of the non-skilled care on the patient’s overall wellbeing. The SN was to develop, manage, and revise the non-skilled plan of care based on the registered nurses’ (RN’s) assessment. Home Health Aide (HHA) services were ordered 4 times a week for 1 week and 5 times a week for 8 weeks for assistance with personal care and activities of daily living (ADLs) secondary to functional limitations which prevent self-care.; and private duty certified nursing assistant (PDCNA) services ordered for 25 hours a week for 9 weeks. Medications- insulin lispro pen 100 units/ milliliter (ml) subcutaneously, three times daily. Review of CNA #1’s Visit Note Report revealed the following: 10/1/2024 at 8:08 AM-Staff helped Patient #1 with insulin, but Patient #1 self-injected. 10/2/2024 at 7:56 AM- Patient #1 took medications. Helped Patient #1 with insulin. 12:56 AM- Helped Patient #1 with insulin. 10/4/2024 at 7:41 AM- Patient #1 took medications. Helped Patient #1 with insulin. 10/7/2024 at 7:50 AM- Helped Patient #1 with insulin. 10/8/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin 10/9/2024 at 7:50 AM- Staff helped Patient #1 with insulin. 12:50 PM- Staff helped Patient #1 with insulin. 10/11/2024 at 9:55 AM- Helped Patient #1 with insulin. 1:55 PM- Staff helped Patient #1 with insulin. 10/14/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin. 10/15/2024 at 8:09 AM- Staff helped Patient #1 with insulin. 9:35 AM- Pt needed more insulin. Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1with insulin. 10/18/2024 at 9:54 AM- Helped Patient #1 with insulin. 10:54 AM- Helped Patient #1 with insulin. 10/21/2024 at 9:01 AM- Helped Patient #1 with insulin. 11:01 AM- Helped Patient #1 with insulin. 1:01 PM- Staff helped Patient #1 with insulin. 2:01 PM- Helped Patient #1 with insulin. 10/23/2024 at 8:20 AM- Staff helped Patient #1with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/25/2024 at 8:20 AM- Staff helped Patient #1 with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/30/2024 at 8:21 AM- Patient #1 had already taken medications. Staff Patient #1 patient with insulin. 1:31 PM- Staff helped Patient #1 with insulin. 11/1/2024 at 8:01 AM- Patient #1 took medications while sitting in the living room. Staff helped Patient #1 with insulin, but Patient #1 self-injected. 11/2/2024 at 6:22 AM- Helped Patient #1 with insulin. 11:22 PM- Helped Patient #1 with insulin. 11/4/2024 at 9:15 AM- Helped Patient #1 with insulin. 12:57 PM Staff helped Patient #1 with insulin. 11/5/2024 at 9:15 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 12:00 PM- Nurse came. 12:38 PM- Nurse left. 1:00 PM- Helped Patient #1 with insulin. 11/6/2024 at 9:00 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 1:00 PM- Helped Patient #1 with insulin. 11/11/2024 at 7:50 AM- Staff checked patient’s vital signs and helped Patient #1 with insulin. 11/12/2024 at 7:31 AM- Staff helped Patient #1 with insulin. 12:31 PM- Staff helped Patient #1 with insulin. 11/15/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 10:00 AM- Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1 with insulin. 11/18/2024 at 8:57 AM- Staff helped Patient #1 with insulin. 10:57 AM- Helped Patient #1 with insulin. 12:57 PM- Staff helped Patient #1 with insulin. 1:57 PM- Helped Patient #1 with insulin. 11/19/2024 at 7:53 AM- Staff helped Patient #1 with insulin. 9:45 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/20/2024 at 7:53 AM- Helped Patient #1 with insulin. 9:55 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/22/2024 at 7:55 AM- “…Patient asked staff some questions on my job description on giving insulin. I called bosses to find out…1355 Leaving PT [patient] in care of self…” Review of the Visit Note Report dated 10/29/2024, revealed, “…RN RECERT [recertification] WITH SKILL [skilled nursing] PRIVATE DUTY…MEDICATIONS…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF CORRECT DOSAGE AT THE APPROPRIATE TIMES/ INTERVALS…ABLE TO INDEPENDENTLY TAKE THE CORRECT MEDICATION(S) AND PROPER DOSAGE AT THE CORRECT TIMES…WERE SUPERVISORY FUNCTIONS PERFORMED? YES. INDICATE DISCIPLINE OF EMPLOYEE BEING EVALUATED: HOME HEALTH AIDE. AIDE NOT PRESENT…INDICATE NAME OF HOME HEALTH AIDE BEING EVALUATED…[Named CNA #1]. AIDE FOLLOWS PLAN OF CARE/ ASSIGNED TASKS…YES…ARE THE INSULIN ADMINISTRATION ORDERS BEING FOLLOWED? YES…IS THE CLIENT/ CAREGIVER INDEPENDENT WITH BLOOD SUGAR ANALYSIS? NO. IS THE CLIENT/CAREGIVER INDEPENDENT WITH INJECTABLE MEDICATION ADMINISTRATION…CHANGES NEEDED TO SERVICES PROVIDED…NO CHANGES IN FREQUENCY/ DURATION, MEDICATIONS, OR TREATMENT…PLAN FOR NEXT VISIT…PD [private duty] RECERT VISIT COMPLETED BY SN…PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…GOALS NOT MET…NON-SKILLED PLAN OF CARE WILL BE EVALUATED WITH APPROPRIATE INTERVENTIONS AND COORDINATION OF CARE TO MAINTAIN PATIENT IN A SAFE ENVIRONMENT WITHOUT EXACERBATIONS OF DISEASE PROCESS…ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…” There were no orders to assist or administer Patient #1’s insulin, and the services received were not consistent with Patient #1’s plan of care; however, the Visit note for 10/29/2024, revealed documentation that CNA #1 was following the plan of care. Review of the Client Coordination Note Report revealed the following: 10/1/2024- “…PD [private duty] SUP [supervisory] VISIT COMPLETED BY SN…PT [patient] IS A DIABETIC AND STATES SHE DOES NOT CHECK HER SUGAR BUT GIVES INSULIN. EDUCATED ON IMPORTANCE OF MONITORING BLOOD GLUCOSE TO PREVENT HYPOGLYCEMIC EPISODE…” Entered by RN #1. 10/29/2024- “…RN RECERT SUP VISIT COMPLETED BY SN...PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…” Entered by RN #1. 11/26/2024- “…MEDICATION ERROR IDENTIFIED. CNA DREW UP AND ADMINISTERED INSULIN ACTING OUTSIDE THEIR SCOPE OF PRACTICE. PATIENT CONTACTED REGARDING THIS. PT STATED CAN HELPED HER BECAUSE SHE WAS HAVING DIFFICULTY GIVING HERSELF INJECTION IN HER ARM. HOME HEALTH NOTIFIED OF PATIENT NEEDING ADDITIONAL EDUCATION ON INSULIN…” Enterer by LPN #1. 11/26/2024- “…EMAIL SENT TO HH REGARDING NEED FOR ADDITIONAL TEACHING ON INSULIN ADMINISTRATION. HH TO NOTIFY NURSE SCHEDULED TO SEE PATIENT THIS WEEK…” Enterer by LPN #1. Review of the Details of the Complaint undated, revealed on 11/22/2024, CNA #1 called LPN #1 (her supervisor) to ask if she was permitted to draw up insulin in a syringe to administer to her patients because one of CNA #1’s patients had questioned her, “...as she has been doing this and wondered if it was within her job duties...” LPN #1 instructed CNA #1 that it was not within the CNA’s scope of practice, and she needed to stop immediately. LPN #1 placed CNA #1 on suspension pending investigation. On 11/25/2024, LPN #1 spoke with CNA #1 further, and she admitted that she had been helping Patient #1 draw up the insulin because Patient #1 had an abdominal hernia (an abnormal protrusion of tissue or an organ through the abdominal wall) and struggled to administer her insulin in her arm. Patient #1 tried to inject the insulin in her arm, but her hands shook. Review of CNA #1’s written statement dated 11/25/2024 revealed, “…PT [patient] got insulin. PT would draw it up in the needle and would put needle in and most of the time push it in. Some days[,] I would help push it in due to pt hands shaking and couldn’t grip it…I only helped when [her] hand would shake[,] and she would have trouble…Staff would squeeze arm for Pt [patient] and Pt would pt [put] needled in arm…There where [were] times that I did draw up the number that the pt would tell me to draw up…” Review of the Separation Notice dated 11/26/2024, revealed CNA #1 was discharged for violation of company policy. Review of the Quality Assessment Performance Improvement (QAPI) Minutes dated 1/21/2024 and 2/18/2025, revealed no documentation of any discussion involving CNA #1 providing medication assistance or CNA #1 administering medications. The agency provided no documentation that CNA #1’s charting was reviewed or and the facility provided not documentation that they reached out to CNA #1’s other patients to identify if there were any other instances of medication administration. The agency provided no documentation that any policy or medication training was conducted after the event(s) was identified. During an interview on 3/5/2025 at 12:25 PM, The Private Duty Executive Director (PDED) stated that CNAs could assist the patient with medications. She said that CNAs could hand the patient their pill planner and remind them to take their medications, but they were not allowed to administer medication. The PDED said the CNAs cannot even touch the medications, and they do not under any circumstances even allow CNAs who are medication certified to administer medications. The PDED said that the event was reported as a medication error and confirmed that there was no documentation of medication training. The PDED also confirmed that there was no documentation of CNA #1 providing assistance or administering insulin recorded on the QAPI meeting minutes. During a phone interview on 3/5/2024 at 1:10 PM, LPN #1, the Clinical Services Manager reported that CNA #1 called the office and asked the scheduler, CNA #2 if she was allowed to administer insulin. She stated that CNA #1 did not administer the insulin the day she contacted the office, the event took place prior to that day. She said CNA #2 contacted the care coordinator, and the coordinator sent email to LPN #1 to let her know what had occurred. LPN #1 said she contacted CNA #1, and she spoke with the patient. She said that CNA #1 had been helping Patient #1 with her insulin, and CNA #1 administered insulin in Patient #1’s arm because Patient #1 had not been able to self-administer the medication. LPN #1 said Patient #1 had a hard time reaching her arm, and she was instructed not to administer her insulin in her stomach because of hernia. LPN #1 said that she explained to CNA #1 that insulin administration was out of her scope of practice. She said CNA #1 knew she was not supposed to administer medications, but she was just trying to help, and she was not thinking. LPN #1 said she emailed to the PDED about process and reached out to Human Resources (HR) Compliance. LPN #1 said that she spoke with Patient #1 several times, and she went back and forth on the issue. She stated that Patient #1 told her CNA #1 drew up insulin, and Patient #1 administered it. LPN #1 stated that she documented talking to Patient #1 and told her that she could administer her own insulin in the top of her thigh. LPN #1 said she reached out to the home health administrator to do more teaching with the patient. She stated the agency reported the incident to (Named State Agency that administers Medicaid) and sent everything she had written to corporate. LPN #1 said that she pulled CNA #1 from the schedule until the facility investigation was completed. She said that Patient #1 was CNA #1’s main patient. LPN #1 stated that she called one of CNA #1’s other patients and looked back at documentation. She stated that she did not identify anything that indicated she had administered medication to any other patients. LPN #1 said that she asked CNA #1 if she had administered insulin to only one patient, but she could not recall CNA #1’s response. During a phone interview on 3/5/2025 at 3:40 PM, the scheduler, CNA #2 reported that CNA #1 called her and stated that she gave insulin to Patient #1. CNA #2 said that she told CNA #1 that she was not allowed to give medications and reported it to LPN #1. CNA #2 said that CNAs were not allowed to administer any medication at all. She stated that CNAs were only allowed to remind patients to take their medications. CNA #2 stated that CNAs were also to remind patients that CNAs were not allowed to administer insulin. She said that she never received any complaints from Patient #1 before the incident, but once they learned that CNA #1 had administered insulin, Patient #1 made it known that she had issues. She stated that Patient #1 was covering for CNA #1 because she did not want to get her in trouble. During a phone interview on 3/10/2025 at 1:10 PM, CNA #1 stated that she guided Patient #1’s hand to her arm because her hand shook. She said that Patient #1 did it herself. She said Patient #1 stuck the needle in and pushed the plunger. When CNA #1 was asked if she ever drew up Ms. Patient #1 insulin, CNA #1 replied, “No ma’am.” CNA #1 said that Patient #1 was the first and only patient she assisted, and CNA #1 provided a statement to the agency.”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on review of the Tennessee Code Annotated (TCA), policy review, record review, documentation review, and interviews, the facility failed to ensure that home health aide services were delivered in accordance with physician orders, the plan of care, state law, and consistent with home health aide training for 1 of 1 patient (Patient #1) reviewed. The findings included: Review of the Tenn. Code Ann. § 63-7-127, “Medication Aides” Copyright 2025, revealed, “...’medication aide’ means an individual who administers medications under the general supervision of a licensed registered or practical nurse...In exercising the authority to administer medications pursuant to a nursing delegation, a medication aide may administer medications in any of the following categories: Oral medications...Topical medications...A medication aide shall not: Administer medications when administration would require a dosage decision or calculation...A medication aide shall not, under any circumstances, administer medications by certain methods or routes, or both, as determined by rule. These methods or routes include, but are not limited to, the following...Subcutaneous...” Review of the agency’s policy “Administration and Documentation of Medications,” dated November of 2023, revealed, “…Non-licensed personnel may, with instruction, supervise and assist with self-administration of medication. Non-licensed personnel may document assisting the patient in his/her self-administration of medications…Non-licensed personnel will not administer medications…” Review of the medical record revealed Patient #1 was admitted to the agency Start of Care (SOC) dated 9/3/2024, with diagnoses including Chronic Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Essential Hypertension, and Diabetes. Review of the Private Duty (PD) Admission Booklet for PD patients revised July of 2020, revealed, “…SERVICES…A CNA [Certified Nursing Assistant] cannot...Prepare or administer medications…YOUR RIGHTS…QUALITY OF CARE- YOU HAVE THE RIGHT TO: Receive high quality, appropriate care…in accordance with physician orders…” Review of the Personnel File revealed the Certified Nursing Assistant (CNA #1) was employed with the agency from 10/25/2023 to 11/22/2024 as a private duty aide. Review of the New Hire Packet dated 10/25/2023, revealed, “…Job Description...Providing hands-on personal care including Baths, Oral Hygiene, Shampoos…and other duties within their scope of practice assigned by supervising clinician…Assisting patients in the self-administration of medication…” Review of the Visit Note Report dated 9/3/2024, revealed, “…RN OASIS ADMISSION PRIVATE DUTY…DIABETES…IS CLIENT TAKING INSULIN? YES. HOW FREQUENT ARE BLOOD SUGARS CHECKED…DAILY AND AS NEEDED…CAN THE PATIENT SELF INJECT INJECTABLE MEDICATION (I.E., INSULIN…)? YES…INDICATE CLIENT’S KNOWLEDGE BASE DEFICITS…MEDICATIONS…DRUG REGIMINE REVIEW: DID A COMPLETE DRUG REGIMEN REVIEW IDENTIFIY POTENTIAL CLINICALLY SIGNIFICANT MEDICATION ISSUES?...NO-NO ISSUES FOUND DURING REVIEW…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF THE CORRECT DOSAGE AT THE APPROPROIATE TIMES/INTERVALS…NA-NO INJECTABLE MEDICATIONS PRESCRIBED…HIGH-RISK DRUG CLASSES USE AND INDICATION: CHECK IF THE PATIENT IS TAKING ANY MEDICATIONS BY PHARMACOLOGICAL CLASSIFICATION…HYPOGLYCEMIC (INCLUDING) INSULIN…GOALS NOT MET…PATIENT/ CAREGIVER DEMONSTRATES SAFE, APPROPRIATE USE OF MEDICATIONS EXCEPTION CODE: ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…MEDICATION UNDERSTANDING CHANGES…[Named insulin lispro pen] [a disposable, pre-filled, insulin pen with 100 units of fast-acting insulin used to treat high blood sugar. The patient is able to rotate the dose knob in order to administer the correct dose] (U-100) INSULIN 100 UNIT/ ML [milliliter] SUBCUTANEOUS…” Review of the Private Duty Plan of Care (PDPOC) certification period from 9/3/2024-11/1/2024, revealed Skilled Nursing (SN) services were ordered once a week for one week and once every 4 weeks for eight weeks to evaluate and develop the plan of care, assess/evaluate co-morbidities, to identify changes, and intervene to minimize complications. SN was to perform management and evaluation to observe and assess underlying conditions, complications, and effects of the non-skilled care on the patient’s overall wellbeing. The SN was to develop, manage, and revise the non-skilled plan of care based on the registered nurses’ (RN’s) assessment. Home Health Aide (HHA) services were ordered 4 times a week for 1 week and 5 times a week for 8 weeks for assistance with personal care and activities of daily living (ADLs) secondary to functional limitations which prevent self-care.; and private duty certified nursing assistant (PDCNA) services ordered for 25 hours a week for 9 weeks. Medications- insulin lispro pen 100 units/ milliliter (ml) subcutaneously, three times daily. There were no skilled or non-skilled services ordered to assist or administer Patient #1’s insulin. Review of CNA #1’s Visit Note Report revealed the following: 10/1/2024 at 8:08 AM-Staff helped Patient #1 with insulin, but Patient #1 self-injected. 10/2/2024 at 7:56 AM- Patient #1 took medications. Helped Patient #1 with insulin. 12:56 AM- Helped Patient #1 with insulin. 10/4/2024 at 7:41 AM- Patient #1 took medications. Helped Patient #1 with insulin. 10/7/2024 at 7:50 AM- Helped Patient #1 with insulin. 10/8/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin 10/9/2024 at 7:50 AM- Staff helped Patient #1 with insulin. 12:50 PM- Staff helped Patient #1 with insulin. 10/11/2024 at 9:55 AM- Helped Patient #1 with insulin. 1:55 PM- Staff helped Patient #1 with insulin. 10/14/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 12:30 PM- Staff helped Patient #1 with insulin. 10/15/2024 at 8:09 AM- Staff helped Patient #1 with insulin. 9:35 AM- Pt needed more insulin. Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1with insulin. 10/18/2024 at 9:54 AM- Helped Patient #1 with insulin. 10:54 AM- Helped Patient #1 with insulin. 10/21/2024 at 9:01 AM- Helped Patient #1 with insulin. 11:01 AM- Helped Patient #1 with insulin. 1:01 PM- Staff helped Patient #1 with insulin. 2:01 PM- Helped Patient #1 with insulin. 10/23/2024 at 8:20 AM- Staff helped Patient #1with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/25/2024 at 8:20 AM- Staff helped Patient #1 with insulin. 10:20 AM- Staff helped Patient #1 with insulin. 1:20 PM- Staff helped Patient #1 with insulin. 10/30/2024 at 8:21 AM- Patient #1 had already taken medications. Staff Patient #1 patient with insulin. 1:31 PM- Staff helped Patient #1 with insulin. 11/1/2024 at 8:01 AM- Patient #1 took medications while sitting in the living room. Staff helped Patient #1 with insulin, but Patient #1 self-injected. 11/2/2024 at 6:22 AM- Helped Patient #1 with insulin. 11:22 PM- Helped Patient #1 with insulin. 11/4/2024 at 9:15 AM- Helped Patient #1 with insulin. 12:57 PM Staff helped Patient #1 with insulin. 11/5/2024 at 9:15 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 12:00 PM- Nurse came. 12:38 PM- Nurse left. 1:00 PM- Helped Patient #1 with insulin. 11/6/2024 at 9:00 AM- Helped Patient #1 with insulin. 11:00 AM- Helped Patient #1 with insulin. 1:00 PM- Helped Patient #1 with insulin. 11/11/2024 at 7:50 AM- Staff checked patient’s vital signs and helped Patient #1 with insulin. 11/12/2024 at 7:31 AM- Staff helped Patient #1 with insulin. 12:31 PM- Staff helped Patient #1 with insulin. 11/15/2024 at 8:00 AM- Staff helped Patient #1 with insulin. 10:00 AM- Staff helped Patient #1 with insulin. 1:30 PM- Staff helped Patient #1 with insulin. 11/18/2024 at 8:57 AM- Staff helped Patient #1 with insulin. 10:57 AM- Helped Patient #1 with insulin. 12:57 PM- Staff helped Patient #1 with insulin. 1:57 PM- Helped Patient #1 with insulin. 11/19/2024 at 7:53 AM- Staff helped Patient #1 with insulin. 9:45 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/20/2024 at 7:53 AM- Helped Patient #1 with insulin. 9:55 AM- Helped Patient #1 with insulin. 12:53 PM- Staff helped Patient #1 with insulin. 11/22/2024 at 7:55 AM- “…Patient asked staff some questions on my job description on giving insulin. I called bosses to find out…1355 Leaving PT [patient] in care of self…” Review of the Visit Note Report dated 10/29/2024, revealed, “…RN RECERT WITH SKILL PRIVATE DUTY…MEDICATIONS…MANAGEMENT OF INJECTABLE MEDICATIONS: PATIENT’S CURRENT ABILITY TO PREPARE AND TAKE ALL PRESCRIBED INJECTABLE MEDICATIONS RELIABLY AND SAFELY, INCLUDING ADMINISTRATION OF CORRECT DOSAGE AT THE APPROPRIATE TIMES/ INTERVALS…ABLE TO INDEPENDENTLY TAKE THE CORRECT MEDICATION(S) AND PROPER DOSAGE AT THE CORRECT TIMES…WERE SUPERVISORY FUNCTIONS PERFORMED? YES. INDICATE DISCIPLINE OF EMPLOYEE BEING EVALUATED: HOME HEALTH AIDE. AIDE NOT PRESENT…INDICATE NAME OF HOME HEALTH AIDE BEING EVALUATED…[Named CNA #1]. AIDE FOLLOWS PLAN OF CARE/ ASSIGNED TASKS…YES…ARE THE INSULIN ADMINISTRATION ORDERS BEING FOLLOWED? YES…IS THE CLIENT/ CAREGIVER INDEPENDENT WITH BLOOD SUGAR ANALYSIS? NO. IS THE CLIENT/CAREGIVER INDEPENDENT WITH INJECTABLE MEDICATION ADMINISTRATION…CHANGES NEEDED TO SERVICES PROVIDED…NO CHANGES IN FREQUENCY/ DURATION, MEDICATIONS, OR TREATMENT…PLAN FOR NEXT VISIT…PD [private duty] RECERT VISIT COMPLETED BY SN…PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…GOALS NOT MET…NON-SKILLED PLAN OF CARE WILL BE EVALUATED WITH APPROPRIATE INTERVENTIONS AND COORDINATION OF CARE TO MAINTAIN PATIENT IN A SAFE ENVIRONMENT WITHOUT EXACERBATIONS OF DISEASE PROCESS…ADDITIONAL TIME REQUIRED TO MEET INTERVENTION/ GOAL…” Review of the Client Coordination Note Report revealed the following: 10/1/2024- “…PD [private duty] SUP [supervisory] VISIT COMPLETED BY SN…PT [patient] IS A DIABETIC AND STATES SHE DOES NOT CHECK HER SUGAR BUT GIVES INSULIN. EDUCATED ON IMPORTANCE OF MONITORING BLOOD GLUCOSE TO PREVENT HYPOGLYCEMIC EPISODE…” Entered by RN #1 10/29/2024- “…RN RECERT SUP VISIT COMPLETED BY SN...PT IS A DIABETIC AND IS BECOMING COMPLIANT WITH MEDS AND CHECKING BLOOD SUGARS…” Entered by RN #1 11/26/2024- “…MEDICATION ERROR IDENTIFIED. CNA DREW UP AND ADMINISTERED INSULIN ACTING OUTSIDE THEIR SCOPE OF PRACTICE. PATIENT CONTACTED REGARDING THIS. PT STATED CAN HELPED HER BECAUSE SHE WAS HAVING DIFFICULTY GIVING HERSELF INJECTION IN HER ARM. HOME HEALTH NOTIFIED OF PATIENT NEEDING ADDITIONAL EDUCATION ON INSULIN…” Entered by LPN #1 11/26/2024- “…EMAIL SENT TO HH REGARDING NEED FOR ADDITIONAL TEACHING ON INSULIN ADMINISTRATION. HH TO NOTIFY NURSE SCHEDULED TO SEE PATIENT THIS WEEK…” Entered by LPN #1 Review of the Details of the Complaint undated, revealed on 11/22/2024, CNA #1 called LPN #1 (her supervisor) to ask if she was permitted to draw up insulin in syringes to administer to patients because one of CNA #1’s patients had questioned her “...as she has been doing this and wondered if it was within her job duties...” LPN #1 instructed CNA #1 that it was not within the CNA’s scope of practice, and she needed to stop immediately. LPN #1 placed CNA #1 on suspension pending investigation. On 11/25/2024, LPN #1 spoke with CNA #1 further, and she admitted that she had been helping Patient #1 draw up the insulin because Patient #1 had an abdominal hernia (an abnormal protrusion of tissue or organ through the abdominal wall) and struggled to administer her insulin in her arm. Patient #1 tried to inject the insulin in her arm, but her hands shook. Review on CNA #1’s written statement dated 11/25/2024 revealed, “…PT [patient] got insulin. PT would draw it up in the needle and would put needle in and most of the time push it in. Some days[,] I would help push it in due to pt hands shaking and couldn’t grip it…I only helped when [her] hand would shake[,] and she would have trouble…Staff would squeeze arm for Pt [patient] and Pt would pt [put] needled in arm…There where [were] times that I did draw up the number that the pt would tell me to draw up…” Review of the Separation Notice dated 11/26/2024, revealed CNA #1 was discharged for violation of company policy. There were no orders to assist or administer Patient #1’s insulin, and the services received were not consistent with Patient #1’s plan of care; however, the Visit note for 10/29/2024, revealed documentation that CNA #1 was following the plan of care. Review of the Home Health Aide Competency Evaluation dated 10/26/2023, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. Review of on-line training from 5/13/2024-9/6/2024, revealed no documentation of medication assistance training or any documentation indicating that administration assistance was not permitted by the agency. During an interview on 3/5/2025 at 12:25 PM, The Private Duty Executive Director (PDED) confirmed there were no orders to assist Patient #1 with medications, and medications assistance was not outlined in the plan of care. She said that CNAs could assist the patient with medications by handing the patient their pill planner and remind them to take their medications, but they were not allowed to administer medication. The PDED said the CNAs cannot even touch the medications, and they do not under any circumstances even allow CNAs who are medication certified to administer medications. The PDED stated that there was a 24 hour on-call service, and there was no reason that CNA #1 could not have been supported. She said that CNA #1 should have called for direction before administering medication. The PDED said that PD used the home health nursing staff to perform supervisory visits, and they try to perform the visits every 30 days. She said that when conducting a supervisory visit, the registered nurse (RN) should perform a quick assessment to ensure the patient’s needs are met and the patient is pleased with their service. When asked if the RN is supposed to review the CNA’s visit notes, she said the RN can, but that fell on the private duty office. The PDED said that the event was reported as a medication error and verified that there was no documentation of any medication training The PDED stated the PD office did not catch CNA #1’s documentation that she was assisting Patient #1 with her medications until after CNA #1 contacted the office about medication administration. During a phone interview on 3/5/2024 at 1:10 PM, LPN #1, the Clinical Services Manager reported said that CNA #1 had been helping Patient #1 with her insulin, and CNA #1 administered insulin in Patient #1’s arm because Patient #1 had not been able to self-administer the medication. LPN #1 stated that Patient #1 told her that CNA #1 drew up insulin, but Patient #1 self- administered. LPN #1 said Patient #1 had a hard time reaching her arm, and she was instructed not to administer her insulin in her stomach because of hernia. LPN #1 said that she explained to CNA #1 that insulin administration was out of her scope of practice. She said CNA #1 knew she was not supposed to administer medications. During a phone interview on 3/5/2025 at 3:40 PM, the scheduler, CNA #2 reported that CNA #1 called her and stated that she gave insulin to Patient #1. CNA #2 said that she told CNA #1 that she was not allowed to give medications and reported it to LPN #1. CNA #2 said that CNAs were not allowed to administer any medication at all. She stated that CNAs were only allowed to remind patients to take their medications. CNA #2 stated that CNAs were also to remind patients that CNAs were not allowed to administer insulin. During a phone interview on 3/10/2025 at 1:10 PM, CNA #1 stated that she guided Patient #1’s hand to her arm because her hand shook. She said that Patient #1 self-injected. She said Patient #1 stuck the needle in and pushed the plunger. When CNA #1 was asked if she ever drew up Patient #1’s insulin, CNA #1 replied, “No ma’am.” CNA #1 said that Patient #1 was the first and only patient she assisted, and CNA #1 provided a statement to the agency.”