Summary:
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 observation, review of the laboratory records, and interview with the laboratory staff and the technical consultant, it was determined that the laboratory failed to select and perform temperature monitoring system in the blood storage freezer, and an incubator in testing systems. The findings included: a. In the sample processing area, a freezer was assigned for blood sample storage, the acceptable temperature for the storage condition was set between - 10 to - 20 oC. b. At the time of the survey @ 10:45 AM, a digital thermometer by Fisher had seen the records with Min - 22 while Max -14 oC which indicated that at some ago, there was a storage condition (-22 oC) was out of the acceptable temperature range of - 10 to - 20 oC. c. There was no indication of the laboratory had taken actions to correct or remedial the problems. d. The laboratory technical consultant affirmed ( 03/01/18 @ 10:50 am) that the out of range condition was not noticed. e. An incubator was used for glucuronization procedure. A digital and a traditional thermometer were used to monitor the temperature of the incubator. f. The digital thermometer has features of "out" and "in" temperatures. f. The digital thermometer for the incubator at the time of survey (@ 3:15 PM) had numbers shown 54 for "out" and 24 for "in". g. The laboratory staff can not explain what these numbers, 54 and 24 oC are, but stated that the two thermometer probes were install reversibly. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) 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 CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview with the laboratory staff and the technical consultant, it was determine that the laboratory failed to use different lot number of the same calibration materials when preparing a control material. The findings included: a The laboratory purchased its calibration materials from Cerillien and prepared its calibration and control materials out of the Cerillient product. b. The laboratory prepared both the calibrators and quality controls out of the the same lot number. c. The laboratory failed to use different lot of the calibration material or purchase the quality control materials from different vendors. d. The laboratory consultant affirmed that the laboratory did not use different lot number to prepare for calibration and quality control materials. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory records and interview with the laboratory staff and the technical consultant, it was determined that the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, or instruments, and document all test result comparison activities. The findings included: a. The laboratory used Sysmex XS-1000i to provide WBC with automated cell differential, RBC, Hemoglobin, Hematocrit and platelet count. b. The laboratory established a criteria of WBC and other parameters to perform a MANUAL WBC cell differentials. c. There was no evidence that the laboratory had established the written policies and procedures to perform "Comparison of test results" and documented all test result comparison activities. D5781