Sugarland Walk In Clinic

Summary Statement of Deficiencies 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 lack of documentation, review of the Abbott iSTAT manufacturer's instructions, and staff interview, the laboratory failed to verify the reportable range at least every 6 months using testing materials with values at the zero or minimal level, the mid-level, and the upper-level of the reportable range for the CHEM8+ test cartridge (sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, total carbon dioxide, hematocrit, and hemoglobin) for 2 of 2 years of 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 -- testing (2021, 2022) reviewed. The laboratory performed approximately 3,204 patient tests annually using the Abbott iSTAT instrument. The findings were: 1. Review of the laboratory's records showed no documentation the reportable range of the analytes tested on the Abbott i-STAT instrument had been verified. 2. Review of the Abbott iSTAT manufacturer's instructions, last revised 2/26/20, showed "Calibration verification procedure is intended to verify the accuracy of results over the entire measurement range of a test as may be required by regulatory or accreditation bodies." 3. Interview with the technical consultant on 3/20/23 at 3 PM confirmed the calibration verification studies had not been completed. -- 2 of 2 --

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 complete blood count (CBC) test record review, lack of documentation, review of the manufacturer's operator's manual, and staff interview, the laboratory failed to follow the manufacturer's instructions to review flagged analytes on the analyzer printout for 1 of 14 (#36617) hematology samples reviewed. The laboratory performed approximately 1700 CBCs per year. The findings were: 1. Review of the Sysmex XP-300 instrument printout for specimen #36617 showed the result for the lymphocyte count was flagged with the code F1 and the mixed leukocyte count was flagged with the code F2. There was no documentation the sample had been reviewed for accuracy. 2. Review of the Sysmex XP-300 operator's manual showed the code F1 indicated the "lymphocyte relative frequency of T1 has exceeded range" and F2 indicated the mixed leukocyte count "frequency of T1 or T2 has exceeded range." 3. Interview with the technical consultant on 5/18/21 at 1 PM confirmed the specimen had not been repeated, and the flagged analytes should have been reviewed for accuracy. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of 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 -- specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on complete blood count (CBC) test record review, lack of documentation, and staff interview, the laboratory failed to ensure the laboratory test records included the identity of the personnel who performed 2 of 14 (#36672, #39923) CBC tests results reviewed. The findings were: Review of the Sysmex XP-300 instrument printouts, patient test reports, and the corresponding hematology specimen log book, showed the laboratory failed to include the identity of the personnel performing the CBC for specimen #39923 collected on 10/11/20, and specimen #36672 collected on 5/7/21. Interview with the technical consultant on 5/18/21 at 12:30 PM confirmed the identity of the testing personnel had not been documented. -- 2 of 2 --

Summary Statement of Deficiencies D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of