Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of manufacturer's operator manual, review of analyzer maintenance records and technical supervisor (TS) interview 9/19/18, the laboratory failed to document monthly maintenance of the Diatron Pictus 700 chemistry analyzer. Review of Diatron Pictus 700 operator's manual revealed section 7.4. "Monthly maintenance recommendations....7.4.1 Washer volume calibration....Following ....Maintenance >Washer Volume Calibration....It is possible the testing and calibration of the washer volume...screen will show the pump steps settings and new pump steps required for system delivery in all four wash steps....Target is that all deliveries are between 500 and 700 microliters. It is recommended the use of the test at least once a week. 7.4.2 Other tasks...Perform a full photometer calibration....Empty an clean washing solution reservoir.....Perform an intensive washer cleaning." Review of Diatron Pictus 700 maintenance records revealed no documentation of monthly maintenance from time of last survey until time of current survey 9/19/18, at period of approximately 26 months. Interview with TS at approximately 1:00 p.m. confirmed the laboratory failed to document monthly maintenance. the TS stated she had not confirmed the laboratory was using the correct maintenance form for the Diatron Pictus 700 analyzer and the analyzer will not let you proceed with patient testing unless the required maintenance is performed first. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 -- 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 manufacturer's package insert, review of laboratory procedures, review of laboratory calibration and calibration verification records and technical supervisor (TS) inerview 9/19/18, the laboratory failed to perform calibration verification at least once every 6 months as required for Ethyl Alcohol (ETOH). Review of Thermo Scientific-Dri Ethyl Alcohol reagent package insert revealed "Quality Control and Calibration.....Both negative and 100 mg/dl alcohol calibrators should be used to calibrate the assay." Review of laboratory procedure and laboratory calibration records for ETOH testing revealed the laboratory performs a weekly 2 point calibration of ETOH using a 0 mg/dl (negative) and a 100 mg/dl calibrator as required per package insert. Review of laboratory procedure "Calibration Verification" revealed "....CLIA/COLA regulations specify the lab must also perform calibration verification at least every six months, using a least three levels of materials that are within the reportable range of the test.....To perform calibrations verification:....2. Run at least three levels of materials, in the same manner and test mode that patient specimens are tested...." Review of laboratory calibration verification records for ETOH revealed the laboratory failed to perform a 3 point calibration verification at least once every 6 months from time of last survey until current survey 9/19/18, a period of approximately 26 months. Interview with TS at approximately 11:00 a.m. confirmed the laboratory had not performed a 3 point calibration verification of ETOH. She stated she did not think it was required because it was a positive or negative result and one of the calibrators used is at the cut off level, 100 mg/dl, so she assumed the calibration verification requirement was met. D5783