Every finding on record at Amedisys Home Health of Virginia LLC

An unannounced Home Health Agency recertification survey was conducted on October 10 -12, 2023 by one (1) Medical Facilities Inspector from The Office of Licensure and Certification, Virginia Department of Health. In conjunction with this survey, the agency's emergency preparedness plan was reviewed. The agency was found to be in compliance with 42 CFR 484.102 Conditions of Participation Emergency Preparedness for Home Health Agencies.

An unannounced Medicare/Medicaid Home Health Recertification survey was conducted at the above noted agency October 10-12, 2023 by one Medical Facilities Inspector from the Office of Licensure and Certification, Virginia Department of Health. The agency identified 1,638 unduplicated admissions for the past twelve (12) months. In conjunction with the survey, (17) clinical records and six (6) personnel files were reviewed. Seven (7) home visits and were conducted. The agency was found to be out of compliance with the Federal requirements of 42 CFR 484, the Medicare/Medicaid Conditions for Certification of Home Health Agencies. Deficiencies were identified and cited in this report.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on a review of clinical records and staff interview it was determined the agency staff failed to ensure a plan of care to contained the specific location of a wound and of a PICC (catheter inserted through a peripheral vein to deliver medications) line as ordered by the physician for two (2) of five (5) patients in the survey sample whom had a wound/PICC line (Clinical records: #6 and #9). Findings: Seventeen electronic clinical records were reviewed in the agency from 10/10-10/12/2023 via read only access. 1. The clinical record for patient #6 was reviewed for the period of 09/12/2023 to 11/10/2023. The plan of care contained orders for the IV therapy management of a PICC line for skilled nurse assessment, observation and response of medication. The plan of care failed to include the PICC location. 2. The clinical record for patient #9 was reviewed for the period of 09/18/2023 to 11/16/2023. The plan of care contained wound care orders that read as follows: Irrigated/cleansed with normal saline/wound cleanser, applied calcium alginate covered with unna boot from end of toes to bend of knee in circumferential manner, applied exudry secured with coflex in circumferential manner". The plan of care failed to include the wound location. The Clinical Manager acknowledged the lack of location of the PICC and wound on the plan of cares prior to and during the exit interview of 10/12/2023. A review of the record revealed the wound was located on left lower extremity.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on clinical record review and interview, it was determined the agency failed to ensure the physician was notified of the patient's condition that may suggest outcomes are not being met or changes are needed in the plan of care. Specifically, the physician was not notified about weight changes for one (1) of three (3) clinical records reviewed in the survey sample who required weight management for heart failure (Clinical record #8). Findings: Seventeen electronic clinical records were reviewed in the agency from 10/10-10/12/2023 via read only access. A review of the clinical record for patient #8 revealed a plan of care with orders that read as follows: Skilled nurse to assess cardiopulmonary system to identify signs of decompensation and intervene to minimize the severity of fluid overload. Assess patient ability to monitor and record daily weights and vital signs. Record patient reported weight, or weigh patient as needed. Report increased edema or weight gain of > (more than) 2 lbs in 1 day or > than 5 lbs in 1 week. A review of the skilled nursing clinical notes for the certification period of 09/11/2023 through 11/09/2023 revealed the patient had a recorded weight of 212 lbs on 09/11/2023 and the next weight recorded was 230 lbs on 09/27/2023. The patient had acquired a weight gain of 18 lbs over a period of 16 days . There was no indication in the record of the nurse having contacted the physician related to the patient's weight gain or making changes to the care plan. On 10/12/2023 an interview with the Clinical Manager acknowledged the lack of documentation reporting the increased weight for the patient. The failure to alert physician to changes that suggest a need to alter the plan of care was reviewed with the Administrator and Clinical Manager during the record review and again at the exit conference on 10/12/2023.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on a review of clinical records and staff interview, it was determined the agency failed to send the patient's discharge summary to the primary care physician or primary care practitioner within 5 business days from the date of the final visit for four (4) of five (5) closed clinical records reviewed in the survey sample. (Clinical record #'s 1, 2, 3 and 5). Findings: Five closed electronic clinical records were reviewed in the agency from 10/10-10/12/2023 via read only access. 1. The clinical record for patient #1 was reviewed for the certification period of 8/07/2023 to 10/05/2023. The record revealed that the patient was discharged from the agency on 08/30/2023. No discharge summary was sent to the primary physician. 2. The clinical record for patient #2 was reviewed for the certification period of 04/25/2023 to 06/23/2023. The record revealed that the patient was discharged from the agency on 05/09/2023. No discharge summary was sent to the primary physician. 3. The clinical record for patient #3 was reviewed for the certification period of 06/20/2023 to 08/18/2023. The record revealed that the patient was discharged from the agency on 0707/2023. No discharge summary was sent to the primary physician. 4. The clinical record for patient #5 was reviewed for the certification period of 03/21/2023 to 05/19/2023. The record revealed that the patient was discharged from the agency on 04/20/2023. No discharge summary was sent to the primary physician. On 10/12/2023 at 11 AM the Administrator confirmed the failed discharge summaries to the primary physician and stated, "The system doesn't notify our PSC (Patient Service Coordinator) of discharges or transfers." The lack of providing a discharge summary within 5 business days of the patient's discharge was acknowledged prior to and during the exit conference with the Administrator and Clinical Manager on 10/12/2023.

Two (2) Medical Facilities Inspectors (MFI) from the Office of Licensure and Certification (OLC), Virginia Department of Health (VDH), conducted an unannouncd Medicare Recertification Survey from January 5 - 7, 2021 at the above- noted Home Health Agency (HHA). The survey was conducted both onsite and remotely through the use of telephone and secure email. In conjunction with the survey, the MFIs reviewed the agency's Emergency Preparedness Plan (EPP). The agency was found to be in compliance with 42 CFR 484.22, the Conditions of Participation: Emergency Preparedness for Home Health Agencies, revised February 21, 2020.

Two (2) Medical Facilities Inspectors (MFI) from the Office of Licensure and Certification (OLC), Virginia Department of Health (VDH), conducted an unannouncd Medicare Recertification Survey from January 5 - 7, 2021 at the above noted Home Health Agency (HHA). The survey was conducted both onsite and remotely through the use of telephone and secure email. The agency was found not to be in compliance with 42 CFR 484, the Conditions of Participation for Home Health Agencies, revised February 21, 2020.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on staff interview, clinical record review, and select policy review it was determined the agency failed to ensure each patient participated in and was informed about the care to be furnished by the agency. Specifically, the agency failed to inform patients of Occupational Therapy (OT) visits the agency was unable to provide for three (3) of ten (10) patients with orders for OT services and whose clinical records were reviewed in the survey sample (clinical records #4, 7, and 13). The findings were: Seventeen (17) electronic clinical records were reviewed virtually offsite in read-only mode from 01/6/2021-01/07/2021. 1. The clinical record for patient #4 contained a plan of care for the certification period of 12/29/2020 through 02/26/2021 with Occupation therapy (OT) to visit the patient for one time a week for one week. The OT missed the visit and documented the visit was missed at the end of the scheduled Medicare week and would be scheduled for the next Medicare week. The clinical record failed to contain documentation the patient was notified the OT would not visit as per the plan of care. 2. The clinical record for patient #7 contained a plan of care for the certification period of 11/30/2020 through 01/28/2021 with Occupation therapy (OT) to visit the patient for one time a week for one week. The OT missed the visit on 12/04/2020 and documented the visit was missed at the end of the scheduled Medicare week and would be scheduled for the next Medicare week. The following week the OT missed the visit and documented the same as above. The third week (12/13/2020) the OT missed and documented weather related. The clinical record failed to contain documentation the patient was notified the OT would not visit as per the plan of care. 3. The clinical record for patient #13 contained a plan of care for the certification period of 08/04/2020 through 10/02/2020 with Occupation therapy (OT) to visit the patient for one time a week for one week. The OT missed the visit on (weeks) 08/07/2020, 08/13/2020, 08/21/2020, 08/27/2020, 09/12/2020, 09/22/2020 and documented the visits were missed at the end of the scheduled Medicare week and would be scheduled for the next Medicare week. The clinical record failed to contain documentation the patient was notified the OT would not visit as per the plan of care. Subsequently, the patient declined services on 9/24/2020 as the patient was being discharged from the agency on the following week. A review of the policy for Coordination of Care reads in part: Visit schedules are coordinated whenever possible. Patients are notified of significant changes in schedule prior to scheduled visit time, unless an emergency situation prevents it. An interview with the Administrator and Clinical Manager on 01/07/2020 at 11:50 am revealed the agency was aware of the problem, as they could not keep up with the demand of patient's needing OT services. They advised that physicians were notified at the time of referral that it might be a delay before the OT could get in to see the patient.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on clinical record review, document review, policy and procedure review, and staff interview, the agency failed to ensure accurate and complete medication reviews for all patients. Specifically, the agency failed to identify incomplete medication instructions for one (1) of three (3) patients receiving insulin who were reviewed as part of the survey sample: Patient #12. Findings: Two (2) Medical Facilities Inspectors (MFI) reviewed 17 electronic health records (EHR) remotely and in the agency on January 6 - 7, 2021. In conjunction with the survey, home visits were completed for seven (7) patients that were actively receiving services from the Home Health Agency (HHA) on January 6, 2021. 1. The MFI reviewed patient #12's EHR on January 6, 2021 and January 7, 2020 for the period of December 20, 2020 to February 17, 2021. Patient #12's most recent Plan of Care (POC), signed on December 18, 2020, included the following information as part of the POC section titled "Medications:" "Humalog Mix 75-25 (U-100) Insulin 100 Unit/Ml Subcutaneous Suspension...Instructions: Self Administers between 80-100 units twice daily based on blood sugar." Humalog Mix was a solution of fast and intermediate acting insulin used to treat diabetes. According to A Veteran's Affairs/Department of Defense Clinical Guideline for the Management of Type 2 Diabetes Mellitus(www.healthquality.va.gov/guidelines/CD/diabetes/Vadoddmcpgfinal508.pdf), SSI orders should be "dosed based upon a number of units assigned to treat a pre-specified glucose range on a scale or table." During a home visit conducted on January 6, 2021 the MFI conducted a medication review with Patient #12. The MFI interviewed Patient #12 regarding the instructions for the Humalog Mix with a start date per the POC of September 11, 2020. The MFI asked Patient #12 how they determine the amount of insulin to administer after checking their blood glucose level. Patient #12 stated, "I just give myself what I need based on my blood sugar and how I feel. I can tell how much I need." The Registered Nurse (RN), Staff Member #4, was present at the time of the home visit. The MFI interviewed the nurse regarding the Humalog Mix instructions. The MFI asked the nurse to explain the instructions for the Humalog Mix. The RN reported that the doctor "gave the patient some leeway with his insulin." The MFI asked the RN if the order was a sliding scale insulin (SSI) order. The RN stated, "Yes." The MFI asked the nurse if their were any additional instructions in Patient #12's POC or medication list for the Humalog Mix. The nurse answered, "No." The MFI asked the RN if the sliding scale order was complete and specific. The RN replied, "No." The MFI asked the RN how they could educate the patient regarding the administration of sliding scale insulin without complete and specific orders. The RN did not respond at the time of the question. The agency's policy and procedure for medication reviews titled "Drug Regimen Review, policy number MA-002, read in part as follows: "When patients are admitted to the Home Health Agency from acute or post-acute facilities, it is the responsibility of the admitting clinican to assure they review the discharge paperwork from the facility to assure all medications with correct dosages are captured... If any problems/concerns are noted, the RN-Clinical Manager or the RN-Director of Opeations must contact the Physician to verify, receive/write subsequent orders and amend the medication profile as indicated." The agency failed to ensure that the insulin order was reviewed for completeness and specificity as part of the medication review during the comprehensive assessment. The above-noted deficiency was acknowledged by the Administrator, Staff Member #1, and the Clinical Manager, Staff Member #2, during an interview on January 6, 2021 and again during the exit conference on January 7, 2021.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on clinical record review, select policy review and interview, it was determined the agency failed to ensure that each patient received the home health services according to a written plan of care. Specifically, the agency failed to ensure each patient's plan of care was individualized and contained patient specific measurable outcomes and goals related to pain for two (2) of four (4) clinical records reviewed in the survey sample who experienced pain (clinical record #9 and 10). The findings were: Seventeen (17) electronic clinical records were reviewed virtually offsite in read-only mode from 01/6/2021-01/07/2021. 1. A review of the clinical record for patient #9 revealed a plan of care with generalized interventions for pain to include skilled nursing to observe, assess, and provided education on management techniques. No patient specific measurable outcomes or goals were identified/documented related to pain on the plan of care to include but not limited to the patient's desired or acceptable level of pain. The patient had pain medication ordered and the nurse documented, "partial effectiveness". The skilled nurses documented on six (6) of eight (8) visits that pain was relieved according to patient's goals however, the plan of care did not indicate what the patient's goals were for pain 2. A review of the clinical record for patient #10 revealed a plan of care with generalized interventions for pain to include skilled nursing to observe, assess, and provided education on management techniques. The patient stated goals included "pain under control". No patient specific measurable outcomes or goals were identified/documented related to pain on the plan of care to include but not limited to the patient's desired or acceptable level of pain. The nurse documented patient utilizing oxycodone and Tylenol prn (as needed) with some effect. The skilled nurses documented on five (5) of eight (8) visits that pain was relieved according to patient's goals however, the plan of care did not indicate what the patient's goals were for pain An interview with the Administrator and the Clinical Manager on 01/07/2021 at 11:50 am revealed the electronic medical record has an alert system that should alert them when pain is listed in the vital sign section that is greater than a seven (7). The clinical manager stated seven (7) is the parameters set that should trigger the alert and nurses should be calling the physician. If the nurse has not called the physician, the clinical manager would call. A review of the policy for Pain Assessment and Management failed to have any information on the parameters as mentioned in the interview and no parameters were listed on the plans of care. The policy for Pain Assessment and Management stated in part: Pain assessment should include ongoing goals and outcomes of pain control and management.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician may choose to include. This ELEMENT is not met as evidenced by: Based on clinical record review, staff interview, and review of policy and procedure, it was determined the agency failed to include all necessary information on the Plan of Care (POC). Specifically, the agency failed to include all medications and treatments on the POC for two (2) of four (4) patients who were receiving oxygen that were reviewed as part of the survey sample: Patients #8 and #11. Findings: Two (2) Medical Facilities Inspectors (MFI) reviewed 17 electronic health records (EHR) remotely and in the agency on January 6 - 7, 2021. In conjunction with the survey, home visits were completed for seven (7) patients that were actively receiving services from the Home Health Agency (HHA) on January 6, 2021. 1. The MFI reviewed the EHR for Patient #8 on January 6, 2021 for the period of 12/24/2020 to February 21, 2021. In conjunction with the survey, the MFI conducted a visit to the home of Patient #8 to observe the Registered Nurse (RN), Staff Member #4, on January 6, 2021. Upon arrival to Patient #8's home, the MFI observed the patient using an oxygen via nasal cannula [a tube that deliver oxygen through the nose] at a rate of three (3) liters per minute. Patient #8's POC failed to contain an order detailing instructions for the use of oxygen and failed to list oxygen in the section titeld "Medications." The MFI asked the RN if oxygen was considered a medication. The RN answered, "Yes, it is." The MFI asked the RN where oxygen orders would be located on the POC. The RN reported, "It is supposed to show up on the medication list." The MFI asked the RN if oxygen was present on Patient #8's POC at the time of the home visit. The RN confirmed that Patient #8's POC failed to list oxygen as a medication and failed to include instructions for the use of oxygen. 2. The MFI reviewed the EHR for Patient #11 on January 6, 2021 for the period of December 27, 2020 to February 24, 2021. In conjunction with the survey, the MFI conducted a visit to the home of Patient #11 to observe the Speech Therapist (ST), Staff Member #7, on January 6, 2021. Upon arrival to the home visit, the MFI observed an oxygen concentrator and oxygen tubing beside of Patient #11. During the visit, the ST applied oxygen to the patient at a rate of two (2) liters per minute. The MFI interviewed Patient #11's caregiver regarding the oxygen. The MFI asked the caregiver how often the patient uses oxygen therapy. Per the caregiver, the patient required oxygen during sleep and "occasionally throughout the day." The MFI asked the caregiver at what setting the oxygen is administered. The caregiver reported that the rate used was two (2) liters per minute. The MFI observed the ST confirm that the oxygen was set at two (2) liters per minute at the time of the home visit. Patient #11's POC failed to contain an order detailing instructions for the use of oxygen and failed to list oxygen in the section titeld "Medications." 3. The MFI requested the agency's policy for medication review and medication reconciliation on January 6, 2020 from the Clinical Manager, Staff Member #2. The policy provided titled "Drug Regimen Review," policy number MA-002, contained the following information: "The Medication profile is completed by documenting - All the patient's medications which includes: medications on written prescriptions and medication bottles; over-the-counter medications; herbal products; vitamins and supplements and oxygen." The Administrator, Staff Member #1, and Clinical Manager acknowledged the above-noted deficiency during an interview on January 6, 2021 and again during the exit conference on January 7, 2021.