Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of quality control of culture media and interview with the laboratory testing personnel on February 15, 2023 at 11:31 AM; it was determined that the laboratory processed 25 out of 25 patient's with a Hektoen enteric agar culture media with exceeded the expiration date from April 28, 2022 to May 19, 2022. The findings include: a. The laboratory used a Hektoen enteric agar for stool culture. b. On February 15, 2023 at 11:28 AM, the cultures media quality control were reviewed. The quality control record showed that the Hektoen enteric agar lot # 441343 with expiration date of April 27, 2022 was used from april 28, 2022 to May 19, 2022. The records showed that a new lot # 488733 was received on May 20, 2022. c. On February 15, 2023 at 11:31 AM, the laboratory testing personnel stated that the laboratory used an expired Hektoen agar culture media to perform and process 25 patient's out of 25 patient's stool culture from April 28, 2022 to May 19, 2022. d. The laboratory did not check the positivity and negativity of culture media nor the ability to support growth, when they used the expired culture media with patient samples. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on routine chemistry calibration verification records review (year 2021-2022) and interview with the laboratory technical consultant on February 15,2023, at 1:20 P. M., it was determined that the laboratory failed to perform at least , every six months, the calibration verification procedures for the glycosylated hemoglobin test processed by the Tosoh G8 HPLC Analyzer. The findings include: 1.The laboratory used the Tosoh G8 HPLC Analyzer for glycosylated hemoglobin test. 2. The review of routine chemistry calibration verification records showed that the calibration verification procedures for the glycosylated hemoglobin test was performed each six months. 2.On February 15, 2023 at 1:25 P.M. review the routine chemistry calibration verification records showed that the glycosylated hemoglobin test calibration verification procedure was performed for year 2022 on November 15,2022. The laboratory failed to performed the glycosylated hemoglobin calibration verification procedure in May 2022. 3.On February 15,2023 at 1:30 P.M., the technical consultant confirmed that the glycosylated hemoglobin calibration verification procedure was performed for year 2022 on November 15,2022. 4.The laboratory processed a total of 4,324 glycosylated hemoglobin patient test from July,2022 to October,2022 D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on laboratory comparison test results records review (year 2022) and interview with the laboratory technical consultant on February 15,2023, at 2:00 P.M., it was determined that the laboratory failed to perform and evaluate, twice a year, the relationship of the following tests performed by the Dxl 800 Access and Access 2 : CK-MB, Troponin I, Estradiol, Hcg and TSH tests during year 2022. The findings include: 1.The laboratory used the Dxl 800 Access and Access 2 to perform CK-MB ( creatine kinase- MB ) , Troponin I, Estradiol, ( human chorionic hormone ) and TSH ( -- 2 of 5 -- thyroid stimulating hormone ) tests. 2.On February 15, 2023, at 2:05 P.M., review of the laboratory comparison test results showed that the laboratory performed the comparison of tests results for: CK-MB, Troponin I, Estradiol, Hcg and TSH tests only on June 8, 2022. 3. On February 15,2023, at 2:10 P.M., the technical consultant confirmed that the laboratory failed to perform and evaluate twice a year . 4.The laboratory processed and reported a total of 2,703 patient's test since June 8, 2022. D5785