Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for Tosoh AIA-900 assays, laboratory freezer temperature logs from 3-1-17 through 12-31-18, and interview with the technical consultant on 1-23-19 at 3:15 p.m., the laboratory failed to follow manufacturer's instructions for storage of frozen specimens for prostate specific antigen (PSA), testosterone, luteinizing hormone (LH), prolactin (PL), estradiol, and parathyroid hormone (PTH) testing on the Tosoh AIA-900 analyzer for 325 days during this time frame. Findings include: Manufacturer's instructions for Tosoh AIA PSA, testosterone, LH, PL, and estradiol assays state, "If the analysis cannot be done within 7 days, the sample should be stored frozen at minus 20 degrees Celsius or below for up to 60 days." Manufacturer's instructions for Tosoh AIA PTH assay states, "If the analysis cannot be done within 24 hours, the sample should be stored frozen at minus 20 degrees Celsius or below for up to 200 days." Review of temperature logs for the freezer compartment of the laboratory refrigerator from 3-1- 17 through 12-31-18 revealed the freezer compartment daily temperatures fell outside the manufacturer's acceptable range for frozen storage of specimens for 325 days from 7-7-17 through 12-31-18. The technical consultant confirmed on 1-23-19 at 3:15 p.m. that testing on the Tosoh AIA-900 analyzer is performed twice per week, and specimens for PSA, testosterone, LH, PL, estradiol, and PTH testing are frozen on the day of collection if the Tosoh AIA-900 analyzer is not in use. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for Tosoh AIA-900 assays, laboratory freezer temperature logs from 3-1-17 through 12-31-18, and interview with the technical consultant on 1-23-19 at 3:15 p.m., the technical consultant failed to establish the parameters for acceptable levels of performance of routine chemistry and endocrinology testing on the Tosoh AIA-900 analyzer and ensure that these levels were maintained throughout the entire testing process from the initial collection of the specimen through sample analysis. Findings include: Manufacturer's instructions for Tosoh AIA PSA (Prostate Specific Antigen), testosterone, LH (Luteinizing Hormone), PL (Prolactin), and estradiol assays state, "If the analysis cannot be done within 7 days, the sample should be stored frozen at minus 20 degrees Celsius or below for up to 60 days." Manufacturer's instructions for Tosoh AIA PTH (Parathyroid Hormone) assay states, "If the analysis cannot be done within 24 hours, the sample should be stored frozen at minus 20 degrees Celsius or below for up to 200 days." Review of temperature logs for the freezer compartment of the laboratory refrigerator from 3-1- 17 through 12-31-18 revealed the technical consultant failed to ensure specimens for PSA, testosterone, LH, PL, estradiol, and PTH testing were stored at temperatures required by the manufacturer for 325 days from 7-7-17 through 12-31-18. The technical consultant confirmed on 1-23-19 at 3:15 p.m. that testing on the Tosoh AIA- 900 analyzer is performed twice per week, and specimens for PSA, testosterone, LH, PL, estradiol, and PTH testing are frozen on the day of collection if the Tosoh AIA- 900 analyzer is not in use. Refer to D5411 (Failure to follow manufacturer's instructions for storage of frozen specimens.) -- 2 of 2 --