Summary:
Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review, observations, and interviews, the laboratory failed to establish procedures to include specimen transportation (refer to D5403 A), failed to establish control procedures to include the laboratory's process for assessing staining control reactivity for flow cytometry testing using the BD FACSLyric instrumentation (refer to D5403 B), failed to establish procedures to include reference intervals for its immunophenotyping and natural killer cells functional assays (D5403 C), failed to ensure blood collection tubes had not exceeded expiration dates (refer to D5417), failed to establish performance specifications for its flow cytometry testing to include reference intervals (refer to D5423 A), failed to establish performance specifications for its flow cytometry testing to include the use of the Countess 3 automated cell counting system (refer to D5423 B), failed to establish accuracy and precision performance specifications for its flow cytometry testing (refer to D5423 C), failed to establish flow cytometry testing analytical specificity performance specifications including interfering substances for antibody cross reactivity (refer to D5423 D), and failed to perform and document positive and negative reactivity for its flow cytometry testing each time of use (refer to D5475). D5403 PROCEDURE MANUAL CFR(s): 493.1251(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 12 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)