Summary:
Summary Statement of Deficiencies D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 manufacturer's instructions of Cenogenics VDRL/STS Test, syphilis serology procedures manual, syphilis serology quality control records from January 2, 2018 to January 11, 2019, policy for Laboratory Method Validation of modified FDA cleared tests and laboratory director and testing personnel interview on January 11, 2019 at 10:35 AM, it was determined that the laboratory failed to meet the requirements for syphilis serology (quantitative Venereal Disease Research Laboratories - VDRL test) from January 2, 2018 to January 11, 2019. The findings include: 1. The laboratory did not perform the quantitative VDRL in accordance with the manufacturer's instructions of Cenogenics VDRL/STS Test. Refer to D5403. 2. The laboratory did not establish the analytical sensitivity (detection limits) of the Cenogenics VDRL/STS Test (modified FDA cleared test) prior reporting patient VDRL quantitative tests. Refer to D5423. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)