Quest Diagnostics - Fort Smith Rrl

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 10/28/25 at 4:07pm, one (of one) containers of "Finntip 1000 Sterile" (Thermo Scientific, lot: 19002U0, Cat: 9401113, expiration date 01/24) were observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 10/28/25 at 4:07pm laboratory director confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel files for all personnel listed on the CMS-209 form, lack 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 -- of documentation, and interviews with laboratory staff, the laboratory director failed to authorize three (of three) testing personnel to perform tests and report results without direct supervision. Survey findings include: A) During a review of personnel files for all personnel, TP-1, TP-2, and TP- 3 (as listed on the form CMS-209) failed to have written authorization from the laboratory director for testing personnel responsibilities and duties without direct supervision. B) In an interview on 10/28 /2025 at 1:14 pm, the laboratory director confirmed the lack of written authorization for the above testing personnel. -- 2 of 2 --

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: By review of personnel records and interview it was determined that the competency of the technical consultant was not assessed by the laboratory director on an annual basis. Findings follow: A) Upon review of personnel files the last documented annual evaluation of the competency of the technical consultant (employee #5 from the form CMS-209) was dated July 2019 and was for another laboratory. B) In an interview, at 10:03 AM on 4/13/22, the laboratory staff member, identified as numbers 3 and 4 on the CMS 209 form, confirmed the lack of competency documentation for the technical consultant. 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 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 -- having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the of three months of Monthly Quality Control (QC) data and Levy-Jennings Charts, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to establish the criteria for acceptability of hematology control materials using statistical parameters for each lot number of control materials on one of three months reviewed. Survey findings follow: A) Review of the Levy-Jennings charts for hematology QC XN-Check Lot numbers 20003101, 20003102, 20003103 performed in March 2022 revealed that all daily results for all three levels appeared to be indistinguishable from the mean target values and the acceptable range for all analytes in complete blood cell testing were defined as the mean target value plus/minus the mean target value resulting in an acceptable range of 0.00 to 2 times the mean target value. Review of acceptable ranges for July and December 2021 revealed that acceptable ranges for CBC analytes were determined by plus/minus two standard deviations. B) In an interview on 4/13 /22 at 11:55 AM the laboratory staff member, identified as number three on the CMS 209 form, stated that an error was made in defining the acceptable range for hematology QC in the hematology instrument for the lot numbers of QC material identified above and for March and the entire use cycle of the lot numbers of QC material testing personnel would not have a correct notification if QC results were unacceptable. D5783