Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of validation studies performed for the complete blood count (CBC) instrument, the first patient reported from the new CBC instrument, and interview with the technical consultant, the laboratory failed to verify the reference range for the new CBC instrument in 2018. The findings include: 1) Observation of the laboratory on June 3, 2019 at 9:15 am revealed the Sysmex XN 430 (serial # 11054) in use for patient CBC testing. 2) Review of the validation studies performed for the Sysmex XN430 CBC instrument revealed the patient reference (normal) range used had not been verified for the new instrument. 3) Review of the first patient reported revealed patient testing began December 3, 2018. 4) Interview with the technical consultant on June 3, 2019 at 11:00 am confirmed the laboratory failed to verify the patient reference (normal) range for the Sysmex XN 430 CBC instrument in 2018. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel competency assessments and interview with the technical consultant, the technical consultant failed to ensure blind testing was included as part of competency assessment documentation in 2018 and 2019. The findings include: 1) Review of testing personnel competency assessment documentation for the complete blood count instrument revealed blind testing was not included in the competency documentation for testing personnel number one competency performed August 2018, or testing personnel number two competency performed February 2019. 2) Interview with the technical consultant on June 3, 2019 at 10:00 am confirmed the technical consultant failed to ensure blind testing was included as part of competency assessment procedures for the complete blood count for testing personnel numbers one and two in 2018 and 2019. -- 2 of 2 --