Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to have a system in place to ensure 1 of 4 mycology test results were reported accurately into patients' electronic medical record in 2022 and 2023. Findings include: 1. Review on 2 /1/2024 of patient potassium hydroxide preparations (KOH prep) test records from 2022 and 2023 revealed 1 (P1) of 4 results were reported incorrectly. P1 KOH prep was performed on 9/26/2023 and recorded on the test log as negative (for fungal elements) and reported in the electronic medical record as "Examination of the slide showed: branching hyphae." 2. Interview on 2/1/2024 at 10:00 a.m. with the Practice Manager (PM) confirmed the above finding and revealed the lab did not have a system in place to review the manually entered test results. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant failed to perform competency assessments semi-annually for 1 of 2 new testing personnel performing microscopy procedures in 2023. Findings include: 1. Review on 2/1/2024 of personnel records revealed 2 new testing personnel performed microscopy procedures (potassium hydroxide preparations and direct wet mount preparations) in 2023. Further review revealed 1 (TP1) of the 2 new testing personnel failed be assessed for test performance in 2023. 2. Interview on 2/1/2024 at 10:00 a.m. with the Practice Manager (PM) revealed proficiency testing (PT) is used for assessments of test performance and confirmed TP1 did not participate any of the 3 PT events in 2023. -- 2 of 2 --