Labcorp Kansas, Inc - Founder's Circle

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the review of the Individualized Quality Control Plan (IQCP) for the i- STAT EG7+ test cartridge from Abbott, the "Monthly IQCP Assessment" log, "IQCP E-OPTIMIZER", lack of

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a lack of available documentation and confirmed during interview with the technical consultant, the laboratory failed to have a procedure approved, signed, and dated by the laboratory director before use. Findings: 1. Upon review of the laboratory procedures, the laboratory director did not approve, sign, and date the laboratory procedure for: TOSOH A1A 360 SN: 27868704 analyzer at time of survey. 2. Interview with the technical consultant on February 24, 2022 at 9:35 a.m. confirmed, the laboratory failed to have a procedure approved, signed, and dated by the laboratory director before use. 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 D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of Quality Assurance (QA) procedure, the lack of available (QA) documents, and interview with staff revealed that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems. Findings: 1. The QA procedure required a mechanism to monitor specimen quality to determine when correction action was needed. 2. No documents were made availible for specimen rejection monitoring at the time of survey. 3. Interview with Technical Consultant (TC) #2 February 25, 2020 at 10:30 a.m. confirmed, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of performance verification documentation for the AIA 360 Tosoh analyzer and interview, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population. Findings: 1. Review of the verification documentation of the AIA 360 Tosoh analyzer, S/N 27868704, installed August 7, 2018, for the analyte Parathyroid hormone (PTH) testing showed no verification of normal values. 2. Interview with TC #2 on February 25,2020 at 12: 20 p.m. confirmed, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of