Caretenders

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview, the agency failed to obtain signatures of the physician or allowed practitioner in order to administer services and treatments for 1 of 2 active patients. (Patient #1) Findings include: 1. According to the “Physician Orders” policy (2.1.008), the Plan of Care, telephone, and/or verbal orders must be signed and dated by the physician or authorized practitioner within 30 days per state regulation. 2. During a record review on 04/20/2026 for Patient #1, Start of Care 03/16/2026, failed to evidence a POC signed and dated by the patient’s ordering physician or authorized practitioner. 3. During an interview on 04/20/2026 at 11:09 AM, the Administrator indicated that the agency did not have a set deadline to obtain the physician signature on the POC and was unsure of the policy. He/she indicated that usually after 30 days the office representative will go to the physician’s office to obtain the signed POC.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure an order for Registered Nurse (RN) evaluation was completed in a timely manner for 1 of 5 active patient records reviewed (Patient #5) and 1 of 1 discharged patient records reviewed (Patient #3). Findings include: Based on record review and interview, the agency failed to ensure an order for Registered Nurse (RN) evaluation was completed in a timely manner for 1 of 5 active patient records reviewed (Patient #5) and 1 of 1 discharged patient records reviewed (Patient #3). Findings include: 1. A policy titled “Physician Orders” indicated but was not limited to: “To outline the process of receiving and documenting physician or authorized practitioner orders…Services are provided according to the most recent orders updating the patient’s Plan of Care…All care and services are provided within acceptable standards of practice…” 2. The clinical record for Patient #3, certification period 06/14/2024 - 08/12/2024, included a Physician’s Order dated 06/17/2024. The order indicated verbal orders received on 06/17/2024 for continuation of PT (Physical Therapy) and Nursing evaluation. The clinical record included a Client Coordination Note dated 06/24/2024. The note indicated a Team Case Conference for Start of Care Conference and Patient #3 needed additional disciplines or care. The clinical record included a Client Coordination Note dated 06/26/2024. The note indicated a missed visit on 06/21/2024 by the Skilled Nurse. The reason the visit was missed was documented as an add-on evaluation. The clinical record included a Physician’s Order dated 06/26/2024. The note indicated to discontinue Registered Nurse (RN) evaluation the week of 06/16/2024; Skilled Nurse to evaluate week of 06/23/2024. The clinical record included a Client Coordination Note dated 07/05/2024. The note indicated a missed visit on 06/28/2024 by the Skilled Nurse. The reason the visit was missed was documented as a staff emergency/illness. The clinical record included a Physician’s Order dated 07/10/2024 to reschedule Skilled Nurse assessment to the week of 7/14/2024 per patient request. 3. The clinical record for Patient #5, certification period 06/11/2024 - 08/09/2024, included a physician’s order dated 07/11/2024 for a nursing evaluation to be completed to assess the patient’s right heel wounds and bilateral pinky toes. The clinical record failed to evidence a nursing assessment had been completed for Patient #5. The clinical record included a client coordination note dated 07/22/2024, documented by PT 2 that indicated but was not limited to the: Patient has still not seen nursing for evaluation, they report that they have not had anybody call to schedule, and that they did not request that the evaluation be moved to this week…” The clinical record included a Physician’s Order dated 07/16/2024 to reschedule the skilled nursing evaluation to the week of 07/21/2024 per the patient request. 4. During an interview on 07/29/2024 at 10:12 AM, Patient #3’s spouse indicated the agency never came to provide nursing services to Patient #3 during his time as a patient. She indicated the patient had a wound that needed cared for by a nurse. The spouse indicated a continued need for nursing services up until the patient died at home. 5. During a phone interview on 07/29/2024 at 10:47 AM, Physical Therapist (PT) 1 indicated Patient #3 was admitted to the agency for Arteriovenous (AV) fistula (a connection that’s made between an artery and a vein for dialysis access) malfunction and based on the initial/comprehensive assessment, would need nursing services to manage wound and medications. PT 1 indicated she obtained a verbal order on 06/17/2024 from the physician for the patient to have an evaluation for skilled nursing services. She indicated as far as she knows, Patient #3 never received skilled nursing services from the agency before he died. She indicated that Patient #3’s spouse was overwhelmed and needed as much help as possible for patient care. 6. During a phone interview on 07/29/2024 at 11:15 AM, PT 2 indicated she never met Patient #3 but did speak to the spouse on the phone after the patient’s death and the spouse indicated nobody from the agency contacted her about starting nursing services after the order was obtained on 6/17/2024 and that she never requested the nursing evaluation visit to be moved. PT 2 indicated office staff were putting orders into clinical records when an evaluation was late or missing, saying the patient or family had requested the visit dates changed, but the patient/family did not request those changes. PT 2 indicated that recently PT was expected to complete Resumption of Care, Start of Care, and Recertification for patients in cases where skilled nursing services were ordered due to a shortage of nursing staff. 7. During an interview on 07/29/2024 at 11:32 AM, the Administrator acknowledged Patient #3 never received skilled nursing services as ordered and indicated being unsure why Patient #3 never received nursing services and that a new process had been implemented for documenting when a patient or family requests a change in visit date. The Administrator indicated the nurse who had entered the order in Patient #3’s clinical record to change the visit date per the patient request was a Patient Care Manager (PCM) from Branch Office #1 who was remotely filling in for Branch Office #2 at the time and was helping with documentation and workflow. 8. During a phone interview on 07/29/2024 at 12:11 PM, RN 1 indicated she works for Entity #2. She indicated she was previously performing remote work for the agency office to help process orders and with “workflow”. RN 1 indicated when a field clinician would receive an order they could let her know and she would enter it into the Electronic Medical Record (EMR). RN 1 indicated she was told to write the order for Patient #3 to reschedule skilled nursing evaluation to the week of 07/21/2024 per the patient’s request. She indicated she couldn’t remember who gave her the order information documented in Patient #3’s clinical record. 9. During an interview on 07/30/2024 at 2:50 PM, the Alternate Administrator acknowledged a skilled nurse evaluation was ordered on 07/11/2024, and documentation of a skilled nurse evaluation was not present in the clinical record for Patient #5. The Alternate Administrator indicated she completed Patient #5’s Skilled Nurse evaluation on 07/22/2024 after learning in a case conference that it had not been completed. She indicated the visit was documented on paper and not yet completed.”

“Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that patient comprehensive assessments were completed by the appropriate skilled professional for 1 of 1 therapy patient records reviewed (Patient #4). Findings include: A policy titled “Patient Assessment, Initial and Reassessment” indicated but was not limited to: “To describe the process of patient assessments…All patients receive ongoing and periodic reassessments. Comprehensive OASIS reassessments are made prior to patient recertification for all adult patients receiving skilled care…Physical Therapists, Speech Therapists, and Occupational Therapists may perform initial/admission comprehensive assessment visits in cased where there are no nursing services ordered or known at the time of referral…A qualified clinician performs a comprehensive assessment or reassessment visit in the following situations: A resumption of care assessment within 48 hours following post-hospitalization discharge notification or on physician-ordered resumption date…” The Clinical Record for Patient #4, Certification Period 05/08/2024 - 07/06/2024, indicated the patient was admitted to the hospital on 06/02/2024 and discharged to home on 06/21/2024 with orders for Physical Therapy, Occupational Therapy, Speech Therapy, and Nursing services. Patient #4 agreed to Resumption of Care (ROC) visit from the agency on 06/28/2024. The Clinical Record included a Client Coordination Note dated 07/10/2024 which indicated Physical Therapy completed the ROC on 06/28/2024 after hospitalization. Prior to hospitalization Patient #4 had skilled nursing, physical therapy (PT), occupational therapy (OT), and speech therapy (SLP) ordered. During chart review, it was found that hospital physician was recommending discharging patient home with PT, OT, SLP, as well as Nursing per Face-to-Face dated 06/24/2024. The patient’s recertification was scheduled to physical therapy however was not placed on therapists tablet until after episode had ended and this therapist was on vacation the last week of the patient’s episode. PT spoke with NP on 07/10/2024 at 12:15 PM and received verbal order to continue Nursing, PT, OT, and SLP services for this patient. During a phone interview on 07/29/2024 at 11:15 AM, PT 2 indicated recently Physical Therapy was expected to complete Resumption of Care (ROC) for patients in cases where skilled nursing services were ordered due to a shortage of nursing staff. During an interview on 07/30/2024 at 1:05 PM, the Administrator acknowledged Physical Therapy completed the ROC after hospitalization on 06/28/2024 for Patient #4. She indicated the patient was ordered nursing services on the hospital discharge instructions and prior to hospitalization. She indicated a Skilled Nurse should have completed the ROC. During an interview on 07/30/2024 at 1:14 PM, the Primary Caregiver for Patient #4 indicated nobody from the agency had been out to see the patient in about 2 or so weeks. They indicated being unsure if therapy or a nurse came for the last visit received. They indicated a continued need and want for home health services through the agency. They indicated patient was getting stronger now than in the past and no current issues at this time.”

“Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure an update of the comprehensive assessment was completed within the last 5 days of every 60 days beginning with the start-of-care date for 3 of 5 active patient records reviewed (Patient #4, #6, #7). Findings include: A policy titled “Patient Assessment, Initial, and Reassessment” indicated but was not limited to: “To describe the process of patient assessments…All patients receive ongoing and periodic reassessments. Comprehensive OASIS reassessments are made prior to patient recertification for all adult patients receiving skilled care…A qualified clinician performs a comprehensive assessment or reassessment visit in the following situations: …Periodic reassessment during the last 5 days of the re-certification, or at least every 60 days…” 2. The Clinical Record for Patient #4, Certification Period 07/07/2024 - 09/04/2024, indicated no documentation present for the certification period, including a Recertification Comprehensive Assessment. 3. The Clinical Record for Patient #6, Certification Period 07/14/2024 - 09/11/2024, indicated a late Recertification date of 07/20/2024. 4. The Clinical Record for Patient #7, Certification Period 07/07/2024 - 09/04/2024, indicated a late Recertification date of 07/10/2024. 5. During an interview on 07/30/2024 at 1:05 PM, the Administrator indicated having no prior knowledge of there being no visits or documentation of Recertification for Patient #4 under the current certification period in the EMR (Electronic Medical Record). She indicated she would need to go ask the Quality Assurance Registered Nurse (RN) what happened. 6. During an interview on 07/30/2024 at 1:14 PM, the Primary Caregiver for Patient #4 indicated nobody from the agency had been out to see the patient in about 2 or so weeks. He indicated being unsure if it was therapy or a nurse who last provided a visit. He indicated a continued need and want for home health services through the agency . He indicated the patient was getting stronger now than in the past and had no current issues at this time. 7. During an interview on 07/30/2024 at 1:30 PM, the Administrator indicated she was not sure why there was no documentation at all for Patient #4 for Certification Period 07/07/2024 - 09/04/2024. The Administrator indicated the Alternate Administrator is the Clinical Director at Branch office #2 and the Administrator sits at Branch office #3 usually. She indicated being unaware the Recertification for Patient #4 was not completed. 8. During an interview on 07/30/2024 at 1:38 PM, the Alternate Administrator indicated Patient #4 was discharged on 07/19/2024. She indicated she was instructed to discharge the patient and do a restart of care because the Recertification was late. The Alternate Administrator indicated she completed the discharge visit on paper and it was incomplete at this time. She indicated the Administrator was aware of the situation. 9. During an interview on 07/31/2024, the Quality Assurance RN indicated that 100% of chart audits were completed last evening to identify missing elements in patients’ records. She indicated the agency has known about the patients’ late recertification for a couple of weeks. 10. During an interview on 07/31/2024, the Administrator indicated Patient #4 was seen either yesterday or this morning for official discharge from the agency since the agency dropped the ball when the Alternate Administrator went to complete the discharge visit on 07/19/2024 on paper. The Administrator indicated late recertification was discovered a week or 2 ago and corporate held a meeting to discuss the plan moving forward. She indicated being aware that a Home Health Administrator is ultimately responsible for monitoring the functions of both offices under the provider license. 410 IAC 17-14-1(a)(1)(B)”

“Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to revise the Plan of Care (POC) to reflect medications the patients were currently taking for 5 of 7 home visits/ (Patient’s #1, #2, #4, #5, & #6) Findings include: 1. A revised policy dated 12/01/2021 titled “Plan of Care” was provided on 01/11/2024 at 1:24 PM by the Administrator. The policy indicated, but was not limited to, “Purpose: To assure an appropriate plan of care is developed and revised in a timely manner for each patient” and “The POC includes…medications and treatment”. 2. On 01/09/2024, the clinical record of Patient #5 was reviewed and a POC was provided by the Administrator. The POC failed to reflect medications the patient was currently taking. The agency failed to revise the POC to include oxycodone (a medication used to treat pain). 3. On 01/09/2024, the clinical record of Patient #6 was reviewed and a POC was provided by the Administrator. The medications on the POC failed to reflect the medications the patient was currently taking. The agency failed to revise the POC to include ascorbic acid (vitamin C) or oxycodone. 4. On 01/10/2024, the clinical record of Patient #1 was reviewed and a POC was provided by the Administrator. The medications on the POC failed to reflect medications the patient was currently taking. The agency failed to revise the POC to include the frequency of the medication to “as needed” for omeprazole (a medication used to reduce stomach acid) and to remove cefuroxime axetil (a medication used to treat infections). 5. On 01/10/2024, the clinical record of Patient #2 was reviewed and a POC was provided by the Administrator. The POC contained a list of medications that failed to reflect medications the patient was currently taking. The agency failed to revise the POC to include fioricet (a medication used for tension headaches). 6. On 01/10/2024, the clinical record of Patient #4 was reviewed and a POC was provided by the Administrator. The medications on the plan of care failed to accurately reflect the medications the patient was currently taking. The agency failed to revise the POC to indicate the correct frequency for aspirin (a medication used as a blood thinner), failed to include the correct dosage for calcium carbonate, failed to include medications the patient was actively taking, vitamin D and Milk of Magnesia (a medication used to treat constipation), and failed to remove a medication the patient was no longer taking, Linzess (a medication used to treat constipation). 7. During an interview on 01/11/2024 at 2:23 PM, the Administrator indicated medication reconciliation should be occurring with every patient at every visit, the POC is communicated with patients, and all disciplines are responsible for reporting new and/or changed medications.”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on record review, and interview, the agency failed to ensure a current plan of care was provided to the patient for 6 of 7 home visits (Patients #1, #2, #3, #4, #5, #6). Findings include: 1. A document titled “Patient Rights and Responsibilities” was provided by the Office Manager on 01/12/2024 at 2:14 PM. The document indicated, but was not limited to, “The patient has the following rights… participate in, be informed about… the care to be furnished, based on the comprehensive assessment”. 2. During a home visit on 01/09/2024 at 9:00 AM with Patient #6, the agency admission home folder was reviewed. The agency failed to ensure a current POC was provided to the patient. 3. During a home visit on 01/09/2024 at 1:00 PM with Patient #5, the agency admission home folder was reviewed. The agency failed to ensure a current POC was provided to the patient. 4. During a home visit on 01/11/2024 at 9:00 AM with Patient #1, the agency admission home folder was reviewed. The agency failed to ensure a current POC was provided to the patient. 5. During a home visit on 01/11/24 at 9:30 AM with Patient #2, the agency admission home folder was reviewed. The agency failed to ensure a current POC was provided to the patient. 6. During a home visit on 01/11/2024 at 11:45 AM with Patient #3, the agency admission home folder was reviewed. The agency failed to ensure a current POC was provided to the patient. 7. During a home visit on 01/11/2024 at 12:00 PM with Patient #4, the agency admission home folder was reviewed. The agency failed to ensure a current POC was provided to the patient. 8. During an interview on 01/09/2024 at 11:00 AM, RN 4 indicated the agency does not provide the POC after the start of care (SOC). 9. During an interview on 01/11/2024 at 9:30 AM, PT 2 indicated that patients are supposed to be mailed a POC after SOC. Employee 4 indicated patient #2 did not have a POC in the home. 10. During an interview on 01/11/2024 at 10:10 AM, RN 6 indicated POC tasks are on the bottom of medication lists given to patients, and should be in the homes of patients, and provided by the agency. RN 6 indicated there was no POC or medication list with tasks in the patient’s home and was unsure whether the patient would be mailed a copy. 11. During an interview on 01/11/2024 at 2:23 PM, the Administrator indicated POC lives in the patient’s chart, they are unsure if the POC is mailed to the patients, but patients should receive a copy. The Administrator indicated needing clarification on the process regarding patients receiving POC.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure standard infection control precautions were followed during an agency tour for 1 of 1 Home Health Agency. Findings include: An agency tour was conducted on 01/11/2024 at approximately 10:27 AM. The Administrator touched a urine specimen bag, found in a small refrigerator, without gloves, while on the agency tour. The Administrator failed to wear gloves while touching the contaminated item and failed to perform hand hygiene after touching the contaminated item. A revised policy dated 12/01/2021 titled “Standard Precautions” was provided on 01/11/2024 at 1:24 PM by the Administrator. The policy indicated, but was not limited to, “Standard Precautions include: Hand Hygiene… perform hand hygiene after touching blood, body fluids, sections, excretions, and contaminated items, whether or not gloves are worn…wear gloves (clean, nonsterile gloves) when touching blood, body fluids, secretions, excretions, and contaminated items”. During an interview on 01/12/2024 at 3:00 PM, the Administrator indicated staff should wear PPE (personal protective equipment), use standard precautions when handling contaminated items, and perform hand hygiene afterward. 410 IAC 17-12-1 (m)”

“Administrator must: CFR(s): 484.105(b)(1) Standard: Administrator. The administrator must: This Standard is not met as evidenced by: Based on observation, record review and interview, the Administrator failed to ensure influenza vaccines were stored in a designated refrigerator with maintained and regulated temperature for 1 of 1 Home Health Agency. Findings include: An agency tour was conducted on 01/11/2024 at approximately 10:27 AM. The break room staff refrigerator and the refrigerator located in the back room did not contain any flu vaccines. There is not a designated refrigerator marked or labeled for specimen and/or vaccine storage in the building. On 01/09/2024 at 1:53 PM a revised policy dated 09/01/2021 titled “Vaccine Storage and Transportation” was provided by the Administrator. The policy indicated but was not limited to “the following vaccines may be stored in the agency’s designated refrigerator with a maintained temperature of 35 degrees F to 46 degrees F: …influenza”. On 01/09/2024 at 1:53 PM a revised policy dated 11/01/2021 titled “Infection Control Plan” was provided by the Administrator. The policy indicated but was not limited to “Influenza Vaccines will be made available to employees and contract staff annually”. On 01/12/2024 at 2:25 PM a document titled “2023 Fu Shots” was provided by the Office Manager. The document included a list of 6 employees to whom the agency administered flu vaccines dated after 10/09/2023. During an interview on 01/08/2024 at 10:32 AM, the Administrator indicated the agency did not offer or provide employees with vaccinations. During an interview on 01/08/2024 at 4:56 PM, the Administrator indicated the back refrigerator’s purpose was to store vaccines but had not been utilized since the beginning of their employment with this agency. During an interview on 01/09/2024 at 9:00 AM, Physical Therapist Assistant (PTA) 2 indicated that the flu vaccine is offered to staff by the home health agency. During an interview on 01/09/2024 at 11:00 AM, Registered Nurse (RN) 4 indicated that the flu vaccine is offered to staff by the home health agency. During an interview on 1/11/2024 at 9:15 AM, RN 6 indicated that the flu vaccine is offered to staff by the home health agency. RN 6 indicated employees were offered and/or given the vaccine around the October 2023 timeframe with vaccines that were kept in a refrigerator at the office in what should be designated and labeled as a refrigerator for vaccines. During an interview on 01/11/2024 at 9:30 AM, Physical Therapist (PT) 2 indicated that the flu vaccine is offered to staff by the home health agency. During an interview on 01/11/2024 at 11:45 AM, RN 5 indicated that the flu vaccine is offered to staff by the home health agency. During an interview on 1/11/2024 at 1:00 PM, LPN 3 indicated the agency offers flu vaccines to staff every year, the vaccine was offered in the early fall timeframe of 2023, employees received vaccines in the office, and was unsure of where the agency stores the vaccines. During an interview on 01/11/2024 at 2:23 PM, the Administrator indicated around 10/09/2023, there were no vaccines in the building, and no further vaccinations were provided to staff after this date. The Administrator then indicated there were originally vaccines in the small refrigerator that were thrown away in the garbage due to no thermometer in the refrigerator and identified the vials as flu vaccines for staff and could not recall if packages had been opened and used. The Administrator further corrected indications that flu vaccines were not disposed of in garbage but were disposed of properly in sharps container.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on record review, and interview, the agency failed to provide a current medication schedule to the patient including medication name, dosage, and frequency for 5 of 7 home visits (Patient #1, #2, #4, #5, #6). Findings include: 1. A policy titled “Monitoring Medications” was provided by the Administrator on 01/11/2024 at 2:12 PM. The policy indicated, but was not limited to, “All clinicians will participate in medication review and reconciliation throughout the episode”. 2. During a home visit on 01/11/2024 at 9:00 AM with Patient #1, the agency admission home folder was reviewed. . The folder failed to include a current medication list. RN 6 provided a medication list to place in Patient #1’s folder during the visit but the list failed to reflect the correct medications the patient was taking. 3. During a home visit on 01/11/2024 at 12:00 PM with patient #4, the agency admission home folder was reviewed. The folder failed to include a current medication list. RN 6 provided a medication list to place in Patient #4’s folder during the visit but the list failed to reflect the correct medications the patient was taking. 4. During a home visit on 01/09/2024 at 9:00 AM with Patient #6, the agency admission home folder was reviewed. The medication list failed to include all the medications the patient was taking including ascorbic acid (vitamin C) and oxycodone (a medication used to treat pain). 5. During a home visit on 01/09/2024 at 1:00 PM with Patient #5, the agency admission home folder was reviewed. The medication list failed to include Oxycodone. 6. During a home visit on 01/11/24 at 9:30 AM with Patient #2, the agency admission home folder was reviewed. The medication list failed to include Fioricet (a medication used to treat tension headaches). 7. During an interview on 01/09/2024 at 11:00 AM, RN 4 indicated the agency does not provide the medication list after start of care (SOC). 8. During an interview on 01/11/2024 at 9:30 AM, PT 2 indicated that patients are supposed to be mailed a medication list after SOC. PT 2 indicated patient #2 did not have an updated medication list in the home. 9. During an interview on 01/11/2024 at 10:10 AM, RN 6 indicated medication lists are in the homes of patients provided by the agency. 10. During an interview on 01/11/2024 at 1:00 PM, Licensed Practical Nurse (LPN) 3 indicated medication lists are in the homes of patients provided by the agency. 11. During an interview on 01/11/2024 at 2:23 PM, the Administrator indicated the agency’s expectation for medication reconciliation is to occur with every patient, every visit, by all disciplines reporting new and changed medications. The Administrator indicated the current medication list should be in the patient’s home folders.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on observation, record review, and interview the Administrator failed to ensure that staff followed standard precautions and guidelines for urine specimen storage for 1 of 1 Home Health Agency. Findings include: During a tour of the Home Health Agency on 01/08/2024 at 10:30 AM, a biohazard bag with an unlabeled urine specimen was observed in an unlabeled miniature refrigerator with no temperature monitoring in a back room of the agency. The Administrator indicated nothing is being kept in the refrigerator and he/she was surprised to see the unlabeled urine specimen in the refrigerator. The Administrator indicated it is not agency procedure to bring specimens collected from patients into the agency office for storage. He/she indicated that further investigation would be needed to explain why the urine specimen was present in the refrigerator. The electronic Code of Federal Regulations (eCFR), 29 CFR 1910.1030 was reviewed on 01/08/2024. The eCFR indicated but was not limited to: “Communication of hazards to employees…warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material…these labels shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting color. Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal…” A document titled “Organizational Responsibilities and Organizational Charts” was provided by the Administrator on 01/09/2024 at 1:53 PM. The document indicated but was not limited to: “The Executive Director thus assumes full legal authority and responsibility for the agency’s overall management and operation, provision of all home health services, fiscal operations, review of the agency’s budget and operational plans and its quality assessment and performance improvement program…” During an interview on 01/09/2024 at 3:50 PM, the Administrator indicated he/she discovered the urine specimen had been dropped of at the agency by the family of a patient. He/she indicated the urine specimen had been appropriately disposed of at time of the interview. A document titled “Standard Precautions” was provided by the Administrator on 01/11/2024 at 1:24 PM. The document indicated but was not limited to: “Specimen Collection…Specimen(s) brought into office are stored in containers with biohazardous labels and are prepared for transport according to the guidelines set by the laboratory collection service…” 410 IAC 17-12-1(c)(1)”