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: Through observation, review of manufacturer's package insert, and interview it was determined that the laboratory failed to ensure that reagents were not used in performing testing past their date of expiration for one of one bottles of 10% Potassium Hydroxide and one of one vials of Free T4 substrate. Findings follow: 1. The laboratory failed to ensure that one of one bottles of 10% Potassium Hydroxide that had exceeded its expiration date was not used in KOH testing. A. On a tour of the laboratory on 7/18/18 at approximately 13:15, one of one bottles of 10% Potassium Hydroxide lot # 5773-00 with an expiration date of APR-2018 was observed adjacent to the microscope in the Women's Clinic testing area. B. In an interview on 7/18/18 at approximately 13:15, the general supervisor identified as number 3 on the CMS 209 form confirmed that the Potassium Hydroxide was in use for patient testing and had exceeded its expiration date. 2. The laboratory failed to ensure that one of one vials of Free T4 substrate was not used for testing after it had exceeded its date of expiration. A. Review of the manufacturer's package insert for the Free T4 substrate revealed that after reconstituting the substrate is stable at refrigerator temperature for seven days. B. On a tour of the laboratory on 7/19/18 at approximately 14:00, one of one vial of Free T4 substrate lot # 1X60053 with a hand written in use date of of 7/6/18 was observed in the laboratory refrigerator (13 days after the in use date). C. In an interview on 7/19 /18 at approximately 14:30, the general supervisor identified as number 3 on the CMS 209 form confirmed that the Free T4 substrate was in use and had exceeded its expiration date. 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 -- 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 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: Through review of manufacturer's package inserts, Sysmex instrument control result summaries, three months of Levey-Jennings Reports for July 2017, November 2017 and March 2018, and interview it was determined that the laboratory failed to establish target mean and ranges for three of three levels of Sysmex e-CHECK XS hematology control material and failed to establish establish the mean target for two of two levels of Alfa Wassermann chemistry controls. Findings follow: 1. The laboratory did not establish their mean target and acceptable ranges for Sysmex e- CHECK XS hematology controls. A. Review of all three levels of the manufacturer's package insert for Sysmex e-CHECK XS hematology controls reveals that "the mean values obtained on e-CHECK XS should be within the expected ranges" and "these expected ranges should not be used as QC file limits". B. Review of all three levels of the Sysmex instrument control result summaries for July 2017, Novemebr 2017, and March 2018 reveal that target mean values for complete blood cell analysis were set identical to the target mean values listed in the manfacturer's package insert and expected range values were not established or set in the instrument. C. Review of the laboratory information system Levey-Jennings report for July 2017, November 2017, and March 2018 revealed that mean target values for complete blood cell analysis were identical to the target mean listed on the manufacturer's package insert and the expected ranges were identical to the range of means listed on the manufacturer's package insert. D. In an interview on 7/18/18 at approximately 1545, the technical consultant identified as number 1 on the CMS 209 report confirmed that the mean target values and expected ranges listed on the manufacturer's pacakge insert were set as target values and acceptable ranges in the laboratory information system and used to evaluate quality control results for acceptability of complete blood count controls. 2. The laboratory did not establish their own mean target value for both levels of Alfa Wassermann Chemistry Controls.. A. Review of the manufacturer's package insert for the Alfa Wassermann Chemistry Controls revealed that "each laboratory should establish its own mean and precision parameters". B. Review of the Levey-Jennings Report in the laboratory information system for Alfa Wassermann Chemistry Controls for July 2017, November 2017, and March 2018 for ten analytes (Albumin, AST, Amylase, BUN, Creatinine, Glucose, Lipase, Sodium, Free T4, and Triglycerides) revealed that mean target values set in the laboratory information system Levey- Jennings report for all analytes for all three months were identical to the mean value listed on the manfacturer's package insert. C. In an interview on 7/19/18 at approximately 1400, the technical consultant identified as number 1 on the CMS 209 -- 2 of 3 -- form confirmed that the mean target values set in the laboratory information system were identical to the target values on the manufacturer's package insert. D5783