Lab Express Corporation

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider, the laboratory was found to be out of compliance with the 42 C.F.R. Part 493 CLIA requirements for the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory failed to successfully participate in their PT program for the analyte Total Cholesterol for two consecutive PT events in 2026 (Event 1 of 2026 and Event 2 of 2026). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the routine chemistry analyte Total Cholesterol for two consecutive PT events in 2026 (Event 1 of 2026 and Event 2 of 2026) resulting in the initial unsuccessful PT performance for Total Cholesterol. Findings include: 1. Review of the CASPER Report 0155D, generated on 08/02/2026, the laboratory received the following unsatisfactory scores for the routine chemistry analyte Total Cholesterol. Total Cholesterol Event 1, 2026 - 40% Unsatisfactory Event 2, 2026 - 0% Unsatisfactory 2. Review of AAB-MLE PT evaluation reports for the chemistry events M1 2026 and M2 2026 confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the routine chemistry analyte Total Cholesterol. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in their PT program for the analyte Total Cholesterol for two consecutive PT events in 2026 (Event 1 of 2026 and Event 2 of 2026). Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in their PT program for the analyte Total Cholesterol for two consecutive PT events in 2026 (Event 1 of 2026 and Event 2 of 2026). Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the technical consultant (TC), the laboratory failed to have available written procedures for the testing of 2 of 39 chemistry analytes (Potassium (K)) and Sodium (Na)) listed on the "Lab Express Corporation...Non Waived Test List" affecting over 20,116 tests. Findings include: 1. Review of the "Lab Express Corporation...Non Waived Test List" revealed 39 chemistry analytes utilized for patient testing. Albumin, Alkaline phosphatase, Alanine transaminase, Aspartate aminotransferase, Total carbon dioxide, Direct Bilirubin, Total Bilirubin, Calcium, Chloride, Cholesterol, Creatinine, Urine Creatinine, C - Reactive Protein, Glucose, Hemoglobin A1C, High - Density Lipoprotein cholesterol, Iron, Low - Density Lipoprotein cholesterol, Magnesium, Phosphorous, Total Protein, Urine Protein, Potassium, Recombinant Human C - Reactive Protein, Sodium, Total Iron-Binding Capacity, Triglyceride, Urea Nitrogen, Uric Acid, Vancomycin, Valproic Acid, Ferritin, Folate, Free T4, Free T3, Total Prostate-Specific Antigen, Thyroid-stimulating hormone, Vitamin B12, and Vitamin D 2. Review of the laboratory's procedure manual revealed the laboratory failed to make available written procedures for the testing of 2 of 39 chemistry analytes, K and Na. 3. Review of patient test records documented 20,116 patient tests were performed for K and Na from January 2024 to January 2025. 4. On 01/14/2025, the TC confirmed the lab failed to have procedures available for testing K and Na. D5403 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)