Central Lab Partners

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Central Lab Partners laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: . Based on record review and interview the technical supervisor failed to ensure the establishment of the laboratory's test performance characteristics and that the verification of the test procedures performed were adequate for accuracy, precision, sensitivity and specificity, when applicable, prior to patient testing and reporting for thirteen (13) of thirteen (13) toxicology and routine chemistry analytes on a newly implemented chemistry analyzer as evidenced by the following: Mindray 800 a) A review of validation studies for thirteen (13) of thirteen (13) analytes for the Mindray 800 checmisrty analyzer implemented on 2/8/22 revealed no documented review and approval by the technical supervisor prior to the implementation of the analyzer for patient testing and reporting. The documented review by the technical supervisor was on 2/13/23. b) Technical supervisor number 2 confirmed in an interview on 3/15/23 at 9:39 a.m. that he had reviewed and signed off on the validation studies after the implementation of the Mindray 800 analyzer for patient testing and reporting. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the Central Lab Partners laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish performance specifications for one (1) of one (1) newly implemented test systems not subject to FDA clearance as evidenced by the following: Fentanyl Specificity and sensitivity: a) A review of validation studies for the Indiko Plus chemistry analyzer revealed that the laboratory failed to address specificity and sensitivity as part of the validation for the high complexity, non FDA categorized, fentanyl analyte. b) The technical supervisor confirmed in an interview on 4/22/21 at 10:00 a.m. that specificity and sensitivity studies had not been included as part of the validation. The laboratory performs 14,976 fentanyl assays annually. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --