Lakes Regional Healthcare

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 10:27 am on 08 /28/2024, the laboratory failed to perform a self evaluation when the laboratory received three ungraded PT scores from two out of five PT testing events from 01/01 /2023- 08/28/2024. The findings include: 1. For 2024 Microbiology 1st event, the laboratory received ungraded PT test scores for the following: * Urine Culture Susceptibility Testing, MIC Testing/CLSI/Trimethoprim/Sulfamethoxazole- specimen UR-01 * Gram Stain Morphology- specimen GS-02 2. For 2024 Microbiology 2nd event, the laboratory received ungraded PT test scores for the following: * Gram Stain- specimen GS-08 6. At the time of the survey, the laboratory did not have additional documentation or

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records, lack of training records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:00 am on 09/26/2022, the laboratory director failed to ensure that prior to testing patient specimens, testing personnel performing moderate complexity testing received the appropriate training for five out of five respiratory therapists (identifiers #2 - #6) The findings include: 1. In February 2022, the respiratory therapy staff, identifiers #2 - #6, started performing arterial blood gas testing on the i-STAT test system. 2. At the time of the survey, the laboratory did not have have training records available for respiratory therapy testing personnel identifiers #2 - #6. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --