Lee County Health Department

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on agency staff interview, clinical record review and agency policy review, the agency failed to ensure clinical documents were completed within regulation time frames or per agency policy for 1 of 7 sampled patients (Patient #4). Failure to maintain timely, accurate and appropriately authenticated and completed clinical record documentation increased the risk that agency staff provided services without up to date information related to the patient’s condition, and decreased the ability of agency staff to communicate effectively in order to coordinate patient care. Findings include: According to the agency’s policy, titled Clinical Records, dated November 2023, required documentation for each service provided must be completed within the following timeframes: home health aide and contracted service notes – 14 days, nursing notes – 5 days, other assessments per specific timeframe according to assessment type. During an interview on 8/27/24 at 1:11 PM, Staff A, Administrator, after reviewing the policy, reported nursing staff had 5 days to complete documentation unless specific assessment called for a specific time frame, home health aides and contracted therapy staff had 14 days to complete documentation. Patient #4 had a start of care date of 7/30/24. Clinical record review revealed: a. Skilled nurse visit note, dated 8/2/24 and 8/7/24, was completed on 8/20/24, 18 days after the visit and 13 days late per policy. b. Skilled nurse visit note, dated 8/7/24, was completed on 8/20/24, 13 days after the visit and 8 days late per policy. The skilled nurse failed to complete visit documentation per agency policy. The above information was reviewed with the Administrator.”

“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 agency policy review, and clinical record review, the agency failed to ensure accurate completion of all pertinent components of the start of care comprehensive assessment within the regulated time frame for 1 of 7 sampled patients. (Patient #7) Failure to accurately and thoroughly complete the start of care comprehensive assessment in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. According to the policy, titled Clinical Records, dated February 2023, assessments must be completed and confirmed with an electronic signature within the specific regulatory time frames to conform. 1. Patient #7 had a start of care date of 4/3/2024. Clinical record revealed the following: a. The comprehensive assessment for start of care, dated as initiated on 4/3/24, was not electronically signed as completed until 4/10/24, which exceeded the requirement by 3 days. The agency failed to complete the start of care comprehensive assessment within 5 calendar days after the start of care. The above findings were reviewed with the agency Administrator.”

“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 agency staff interviews, record reviews, and policy review, the home health agency failed to ensure the drug regimen review identified at a minimum the effectiveness of drug therapy, drug side effects, actual or potential drug interactions, duplicate drug therapy, and/or patient compliance with medications for 4 of 7 sampled patients (Patients #2, #5, #6 and #7). Failure to ensure medications reviewed at the time of each drug regimen review are current and accurate and failure to identify actual/ potential concerns increased the potential for unidentified medication interactions and side effect risks to the patient at the time of each comprehensive assessment. 3. Patient #5 had a start of care date of 8/12/24. Clinical record review revealed: a. Start of Care comprehensive assessment, dated 08/12/24, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. The RN failed to complete a drug regimen review that included the 5 required components of ineffective drug therapy, significant side effects, potential drug interactions, duplicate drug therapy and non-compliance with therapy. 4. Patient #7 had a start of care date of 4/3/24. Clinical record review revealed: a. Start of Care comprehensive assessment, dated 04/3/24, included documentation of potential drug interactions and compliance, but lacked documentation of ineffective drug therapy, side effects and duplicate medications. b. Recertification comprehensive assessment, dated 5/29/24, included documentation of potential drug interactions, but lacked documentation of ineffective drug therapy, compliance with medication, duplicate medications and side effects. c. Resumption of Care comprehensive assessment, dated 7/9/24, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. No further information was provided by the agency prior to the end of the survey. According to the agency policy, titled Drug Regimen Review and dated October 2023, on admission the Registered Nurse (RN) shall check all medications a patient may be taking to identify potential adverse effects and drug interactions, including ineffective therapy, significant side effects, significant drug interactions, duplicate drug therapy and non-compliance with therapy. The nurse shall review all medication effectiveness to ensure appropriateness, and to identify potential interactions, potential side effects, ineffective drug therapy or duplicate drug therapy. The drug regimen review (DRR) will be completed when a comprehensive assessment is completed: upon admission, every 60 days following admission, resumption of care, and discharge. During an interview on 8/27/24 at 1:11 PM, Staff B, Clinical Manager, reported RNs complete a drug regimen review at the time of start of care, resumption of care, recertification and at discharge. 1. Patient #2 had a start of care date of 11/28/23. Clinical record review revealed: a. Start of Care comprehensive assessment, dated 11/28/23, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. b. Resumption of Care comprehensive assessment, dated 1/23/24, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. c. Recertification comprehensive assessments, dated 3/25/24, 5/22/24 and 7/24/24, included documentation of duplicate drug therapy, potential drug interactions and compliance but lacked documentation of ineffective drug therapy and side effects. The RN failed to complete a drug regimen review that included the 5 required components of ineffective drug therapy, significant side effects, potential drug interactions, duplicate drug therapy and non-compliance with therapy. 2. Patient #6 had a start of care date of 8/25/23 and a discharge date of 2/20/24. Clinical record review revealed: a. Start of Care comprehensive assessment, dated 8/25/23, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. b. Recertification comprehensive assessment, dated 10/20/23, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. c. Recertification comprehensive assessments, dated 12/21/23, included documentation of duplicate drug therapy, potential drug interactions and compliance but lacked documentation of ineffective drug therapy and side effects. d. Discharge comprehensive assessment, dated 2/20/24, included documentation of duplicate drug therapy and potential drug interactions but lacked documentation of ineffective drug therapy, side effects and compliance. The RN failed to complete a drug regimen review that included the 5 required components of ineffective drug therapy, significant side effects, potential drug interactions, duplicate drug therapy and non-compliance with therapy.”

“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 clinical record review and agency policy review, the agency failed to ensure accurate completion of all required components of the recertification comprehensive assessments between day 56 and 60 of each 60 day certification period for 1 of 7 sampled patients requiring a recertification assessment. (Patient #1) Failure to accurately and thoroughly complete recertification comprehensive assessments in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. According to the policy, titled Clinical Records, dated February 2023, assessments must be completed and confirmed with an electronic signature within the specific regulatory time frames to conform. Patient #1 had a start of care date of 4/9/14. Clinical record review revealed: a. An update to the comprehensive assessment for recertification, dated as initiated on 4/12/24, was not electronically signed as completed until 4/20/24, 5 days into the new certification period. The assessment was not completed by day 60 as required by regulation. b. An update to the comprehensive assessment for recertification, dated as initiated on 6/12/24, was not electronically signed as completed until 6/17/24, 2 days into the new certification period. The assessment was not completed by day 60 as required by regulation. c. An update to the comprehensive assessment for recertification, dated as initiated on 8/9/24, was not electronically signed as completed until 8/17/24, 4 days into the new certification period. The assessment was not completed by day 60 as required by regulation. The agency failed to update the comprehensive assessment in the last 5 days of the 60 day episode. The above information was shared with the Agency Administrator and the Nursing Manager, prior to the end of the survey.”