Supreme Home Health Agency Inc.

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on interview and record review, the agency failed to ensure OASIS (Outcome and Assessment Information Set – patient specific information used in Medicare to determine reimbursement and measure quality) data (facts collected for analysis) for patient assessments was transmitted to CMS (Center for Medicare and Medicaid Services) within 30 days of completing the assessments, for one of seven sampled patients (Patient 7). This failure caused missing and delayed information to CMS with the potential to result in inaccurate reimbursement calculations and quality measurement. Findings: On February 28, 2024, Patient 7’s record was reviewed. A review of Patient 7’s face sheet (a document that provides a summary of a patient’s information), indicated a start of care date of September 22, 2023, with a recertification period of September 22, 2023, to November 20, 2023. Patient 7 had diagnoses which included ataxia following cerebral infarction (loss of muscle control and coordination). A review of Patient 7’s OASIS Start of Care (SOC) Assessment dated September 23, 2023, indicated the document was signed by the Registered Nurse (RN) as complete or exported to CMS on October 25, 2023 (32 days passed Patient 7’s OASIS SOC Assessment was initiated). A review of Patient 7’s OASIS Discharge Assessment, dated November 16, 2023, indicated Patient 7’s Discharge OASIS Assessment was signed by the RN as complete on December 27, 2023 (42 days passed Patient 7’s Discharge OASIS Assessment had been completed). On February 28, 2024, at 2:15 p.m., an interview was conducted with the Director of Patient Care Services Designee/Administrator Designee (DPCS/ADM Designee). The DPCS/ADM Designee stated she was aware the OASIS Assessments for Patient 7 had been exported to CMS after 30 days. She stated all OASIS Assessments should have been signed and exported to CMS within 30 days. A review of the policy and procedure titled “OASIS Data Transmission,” revised May 2022, indicated,”…The organization will encode and transmit completed OASIS data for each applicable patient within thirty (30 days) of the M0090 date, date assessment completed...The organization may take up to thirty calendar days after the date of completion of the comprehensive assessment to enter the OASIS data into their computers using IQIES or software that conforms to all CMS data transmission specifications available on the OASIS website...””

“Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide’s performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency failed to complete an Initial Assessment Skills Checklist for Certified Home Health Aide 1 (CHHA 1) prior to furnishing in home services on behalf of the Home Health Agency. This failed practice placed medically compromised patients at risk of harm due to receiving unskilled care. Findings: On February 26, 2024, a review of an employee file for CHHA 1 was conducted. The employee file did not contain any evidence that the Home Health Agency provided an Initial Assessment Skills Checklist for CHHA 1. On February 29, 2024, at 2:15 p.m. an interview was conducted with the Director of Patient Care Services (DPCS)/Administrator (ADM) Designee. The DPCS/ADM Designee stated the employee file for CHHA 1 was incomplete and did not have an initial assessment skills check conducted by a Registered Nurse. A review of the policy and procedure titled, “Competency Assessment,” revised May 2022 indicated,”...as part of the orientation process, a preceptor/Clinical/assigned Supervisor will be assigned to each new person. Using a Competency Skills Performance checklist, and the Orientation checklist, the preceptor/Clinical/assigned Supervisor will observe the new personnel performing the required skills and activities. Upon completion of the checklists, the new staff will end initial orientation...””

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the clinical records contained accurate comprehensive medication profiles, for two of three patients reviewed (Patients 1 and 2), when the medication profiles did not accurately reflect the medications Patients 1 and 2 were taking in the home. This failure increased the potential for the patients to not receive medications and treatments as ordered by the physician, placing the patients at risk for side effects, drug interaction, duplicate drug therapy, an increase in symptoms the medications were prescribed for, and possible non-compliance with physician’s orders and medication and treatment effectiveness. 2. On February 27, 2024, beginning at 10:30 a.m., a home visit was conducted with LVN 1 for Patient 2. Patient 2 was residing in an Assisted Living Facility (ALF- a group setting providing housing and personal care to it’s residents). LVN 1 requested Patient 2’s Medication Administration Record (MAR) from the staff in charge, and asked if there were any changes to Patient 2’s medications. The staff in charge stated there was none. LVN 1 further asked if there were medications that needed to be refilled, to which the staff in charge replied they were already filled by Patient 2’s pharmacy. LVN 1 was interviewed regarding the process of medication reconciliation. LVN 1 stated he had checked the new MAR provided to him by the facility, and there were no changes compared to the MAR that he had from last week’s visit. LVN 1 further stated before the home visit, he had already compared the previous week’s MAR to Patient 2’s POC and MP, and both were correct. When asked if he conducted an actual observation of Patient 2’s medication bottles, LVN 1 stated the ALF’s staff conducted that task, since they were the ones administering the medications to Patient 2. LVN 1 further stated he just made sure that Patient 2’s medications on the facility’s MAR matched the medications listed in Patient 2’s POC and MP. On February 27, 2024, Patient 2’s record was reviewed. Patient 2 was admitted to the agency on February 10, 2024, with diagnoses which included other malaise (general discomfort or illness), high blood pressure, paranoid schizophrenia (a psychiatric disorder), constipation, and anxiety disorder. The following were found: a. The medication Cholecalciferol (Vitamin D3 dietary supplement) was listed as Cholecalciferol 25 mg (milligram- unit of measurement) to be taken once daily by mouth in Patient 2’s POC and MP, but was listed as Cholecalciferol 25 mcg (microgram-unit of measurement, 1000 times smaller than a milligram) to be taken once daily by mouth on the MAR at the ALF; b. The medication Hydroxyzine (used to help control anxiety and tension caused by nervous and emotional conditions) was listed as Hydroxyzine Hydrochloride (HCl) 25 mg, to be taken once daily by mouth as needed for anxiety on the POC and MP, but was listed as Hydroxyzine HCl 25 mg, to be taken once every six hours by mouth as needed for anxiety on the MAR at the ALF; c. The medication Milk of Magnesia (a laxative) was listed as Milk of Magnesia suspension 30 ml (milliliter- a unit of measurement) to be taken by mouth once a day as needed for constipation on the MAR in the ALF, but was listed as Milk of Magnesia suspension 30 ml to be taken by mouth as needed for constipation on the POC and MP (no frequency was indicated); and d. The medication Ammonium Lactate 12 % (percent) lotion to be applied topically (on the skin) everyday as needed was listed on the MAR at the ALF, but not on Patient 2’s POC and MP. On February 29, 2024, at 2:22 p.m., the DPCS/ADM Designee was interviewed. The DPCS/ADM Designee stated she expected the nurses to physically check patients’ medication bottles and ensure they were correctly listed the patients’ MP and POC in whatever home setting the patients were in. The DPCS/ADM Designee further stated Patient 2’s medication reconciliation should have been done that way. A review of the agency’s policy and procedure titled, “Medication Profile,” revised May 2022, indicated, “…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 medications and new and/or discontinued medications…Deviations in taking medications is communicated in clinical notes, and the physician...will be notified...” Findings: 1. On February 27, 2024, at 8:00 a.m., during a home visit conducted with the Certified Home Health Aide (CHHA 1) and in the presence of Patient 1’s caregiver, Patient 1’s actual medication bottles available in the home were compared with Patient 1’s Medication Profile. On February 27, 2024, at 8:30 a.m., Patient 1’s caregiver stated she has assisted the patient with all her medications and the nurses that came from the agency have not compared the medication bottles with the patient’s Medication Profile since the patient was admitted to the home health agency. On February 27, 2024, Patient 1’s record was reviewed. The following medications were documented in Patient 1’s Plan of Care (POC) and Medication Profile (MP) but was not observed available for administration at Patient 1’s home: - Potassium Cl (chloride) ER (extended release) (electrolyte supplement) 20 meq (milliequivalent - unit of measurement) orally daily; - Tramadol 50 mg (milligram - unit of measurement) (pain medication) 1 (one) tablet orally every 6 (six) hours as needed; and - Lasix (diuretic to treat fluid retention and swelling in the body) 20 mg tablet, 1 (one) tablet orally daily. On February 27, 2024, at 8:30 a.m., an interview was conducted with Patient 1’s caregiver. Patient 1’s caregiver stated the potassium chloride ER, Lasix, and tramadol had been discontinued since Patient 1’s start of care with the home health agency. The following medications were being administered to Patient 1 but was not listed in the patient’s POC and MP: - Lipitor (medication to lower cholesterol level) 40 mg, one tablet daily; and - Gabapentin (medication to treat nerve pain) 100 mg, four capsules daily. The medication vasotec (medication that controls blood pressure) was listed on the Patient 1’s POC and MP without a frequency of when the medication was to be taken. On February 29, 2024, at 2:22 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated she expected the licensed nurses to physically check the patient’s medication bottles and ensure they coincide with the MP.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure verbal orders were signed within 30 days according to the agency’s policy and procedure, for one of seven sampled patients (Patient 7). This failure resulted in Patient 7 receiving services and procedures not authorized by a physician. Findings: On February 28, 2024, Patient 7’s record was reviewed. A review of Patient 7’s face sheet (a document that gives a patient’s information), indicated a start of care date of September 22, 2023, with a certification date of September 22, 2023, to November 20, 2023. Patient 7 had a diagnoses which included ataxia following cerebral infarction (loss of muscle control and coordination). A review of Patient 7’s “Order/Telephone Order,” dated September 29, 2023, indicated, “PT frequency of 1wk1 (one time a week for one week); 2wk3 (two times a week for 3 weeks), and 1wk1 (one time a week for one week)...” The telephone order was signed by the physician on November 3, 2023 (36 days after the verbal order was obtained). On February 27, 2024 at 2:10 p.m, an interview was conducted with the Director of Patient Care Services (DPCS)/Administrator (ADM) Designee. The DPCS/ADM Designee stated she was aware all verbal orders should be sent to the physician to be signed and returned within 30 days. She stated Patient 7’s physical therapy (PT) verbal order was not signed within 30 days. A review of the policy and procedure titled, “Verification of Physician Orders,” revised May 2022 indicated,” …signed orders will be placed in the clinical record within 30 days of initiation of the order, unless otherwise specified by applicable state law and regulation...””

“Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency failed to conduct an annual Employee Performance Evaluation, for four of four sampled employees (Employees 1, 2, 3, and 4). This failure resulted in employees not receiving feedback related to their job performance. Findings: A review of the employee files was conducted on February 26, 2024, the following were found: 1. Employee 1’s personnel file indicated a hire date of January 19, 2023. There was no documented evidence Employee 1 had a Performance Evaluation from the Home Health Agency. 2. Employee 2’s personnel file indicated a hire date of September 1, 2022. There was no documented evidence that Employee 2 had a Performance Evaluation from the Home Health Agency. 3. Employee 3’s personnel file indicated a hire date of December 13, 2021. There was no documented evidence that Employee 3 had a Performance Evaluation from the Home Health Agency. 4. Employee 4’s personnel file indicated a hire date of December 14, 2022. There was no documented evidence that Employee 4 had a Performance Evaluation from the Home Health Agency. On February 29, 2024, at 2:15 p.m., an interview was conducted with the Director of Patient Care Services (DPCS)/Administrator (ADM) Designee. The DPCS/ADM Designee stated, she was aware that the Home Health Agency was lacking in staff to assist with reviewing and organizing the personnel files. A review of the policy and procedure titled, “Competency Assessment,” revised May 2022 indicated, “...During the annual performance evaluation, staff’s competence in performing specified activities will be evaluated...Improving skills for competency will be part of the annual performance evaluation and performance plans for the next year, as well as establishing individual goals for personal/professional growth and development...””

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure the hiring of qualified employees by incomplete employment files for two of five sampled employees (Employees 1 and 2). This failure had the potential to place the patients at a potential risk from receiving care from unqualified staff. Findings: A review of Employee 1’s personnel file indicated a hire date of January 17, 2023. Employee 1 had an incomplete Initial Competency Assessment Skills Checklist for a Registered Nurse; this form was not signed or dated by Employee 1 nor was there a date on the Competency Assessment form by a supervisor. A review of Employee 2’s personnel file indicated a hire date of September 21, 2021. Employee 2 had an incomplete Initial Competency Assessment Skills Checklist for a Registered Nurse; this form was not dated by Employee 2 nor was there a signature and date on the Competency Assessment form by a supervisor. An interview was conducted with the Director of Patient Care Services (DPCS)/Administrator (ADM) Designee on February 29, 2024, at 2:15 p.m. The DPCS/ADM Designee stated she was aware that the agency was lacking in staff to assist with reviewing and organizing the personnel files. A review of the policy and procedure titled, “Competency Assessment,” revised May 2022 indicated, “…as part of the orientation process, a preceptor/Clinical /assigned Supervisor will be assigned to each new person. Using a Competency Skills Performance checklist, and the Orientation checklist, the preceptor/Clinical/assigned Supervisor will observe the new personnel performing the required skills and activities. Upon completion of the checklists, the new staff will end initial orientation…””