Summary:
Summary Statement of Deficiencies D0000 An initial survey was completed 10/27/2023. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 CFR 493.1212 Condition: Endocrinology 42 CFR 493.1403 Condition: Moderate Complexity Laboratory Director 42 CFR 493.1409 Condition: Technical Consultant - Moderate Complexity 42 CFR 493.1421 Condition: Laboratory Testing Personnel D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on lack of proficiency testing records and an Individualized Quality Control Plan (IQCP); review of Frend operator manual, quality control (QC) records, QC manufacturer's package insert; observations made during the survey and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), the laboratory failed to: twice annually verify the accuracy of the analyte, testosterone, refer to D5217; include all the necessary policies and procedure for performing testosterone testing, refer to D5403; ensure the laboratory director approved, signed and dated all policies and procedures, refer to D5407; complete an IQCP plan for performing testosterone QC and perform electronic QC each day of patient testing, refer to D5445; perform external testosterone QC each day of patient testing, refer to D5449; and take