Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory calibration records and interview with the laboratory owner 2/21/23, the laboratory failed to retain calibration records for the testing performed on the Diatron Pictus 500 analyzer from July 2022 through December 2022, a period of approximately 6 months. Findings: Review of laboratory calibration records revealed no documentation of calibrations performed from July 2022 through December 2022. Interview with laboratory owner at approximately 2:30 p.m. confirmed the laboratory failed to retain calibration records from July 2022 through December 2022. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API ) proficiency testing (PT) records, the absence of records, and interview with the laboratory owner 2/21/23, the laboratory failed to verify the accuracy of their urine toxicology testing at least twice during 2022. Review of API PT records revealed the laboratory was enrolled for urine toxicology testing during 2021 and participated in the 2021 1st and 2nd Chemistry 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 -- Miscellaneous test events. Review of API PT records revealed the laboratory was also enrolled for 2023. There were no records of enrollment or participation in API PT for 2022. During interview at approximately 11:20 a.m., the laboratory owner stated she did not think PT was ordered for 2022. She stated that messages from API were sent to the personal email of a former employee, so she was unable to track the messages. She stated that they had not been able to locate any documentation of participation in PT or other activities to verify the accuracy of the urine toxicology testing during 2022. 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) -- (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 review of laboratory procedure, review of 2020, 2021, 2022, and 2023 calibration and calibration verification records 2/21/23, the laboratory failed to perform a three point calibration verification every 6 months for the quantitative potential hydrogen (PH) and Urine Creatinine testing 3 of 4 required verifications since testing began 12/30/20. Findings: Review of laboratory procedure "Calibration and Quality Control Testing for the Pictus 500" revealed "Calibration verification: This is performed every six (6) months for analytes that are reported out quantitatively and have less than 3-point calibration.". Review of 2020, 2021, 2022 and 2023 calibration records for quantitative PH and Urine Creatinine testing revealed the laboratory performs a 2-point calibration for PH and Urine Creatinine. Review of 2020, 2021, 2022, and 2023 calibration verification records revealed the laboratory performed calibration verifications for PH and Urine Creatinine in December 2021, 12 months after testing began, and February 2023, 14 months after last calibration verification was performed. D5781