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 surveyor's review of the chemistry calibration records and an interview with the technical consultant and the testing person, the laboratory failed to discontinue the use of expired calibration materials. FINDINGS: 1) On January 3, 2019 at approximately 12:00 PM the technical consultant and the testing person confirmed surveyor findings that the laboratory used expired calibrator materials, lot number 76193U100 expired July 28, 2018 to calibrate Vitamin D 25 OH testing on August 6, 2018. 2) Approximately 100 patients were tested for VitD 25 OH testing using the expired calibrator materials during the above time frame. PLEASE NOTE: THIS IS A REPEATED CITATION FROM THE SURVEYS CONDUCTED ON MARCH 24, 2015 AND FEBRUARY 3, 2017. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory Quality Control (QC) records and an interview with the technical consultant and the testing person, the laboratory failed to perform lot to lot verification of the Abbott Architect i2000 and the Immulite 2000 analyzers assayed controls. Findings: At approximately 1:00 PM on January 3, 2019, the technical consultant and the testing person confirmed that the laboratory had not verified chemistry, endocrinology and immunology assayed QC prior to use in calendar years 2017 and 2018. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the surveyor's review of laboratory records, the laboratory director failed to provide overall management and direction of the laboratory. The laboratory director failed to ensure that the laboratory had: 1. Maintained the