Summary:
Summary Statement of Deficiencies D0000 A Certification survey was performed on January 26, 2023 at Acadia Laboratory, LLC, CLIA ID 19D0461162. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of policies, quality control (QC) records, and interview with personnel, the laboratory failed to retain QC raw data to support QC range adjustments for Chemistry testing for at least two (2) years as required. Findings: 1. Review of the laboratory's "Quality Control" policy under the "Record Retention" section revealed "Analytic systems records-Retain quality control and patient test records (including instrument printouts, if applicable) and all analytic systems activities for at least 2 years." 2. Review of the laboratory's "Determination of Target Values Multiqual Unassayed Lot # 56691/56693" document revealed a summary chart that included the "mean, 2 SD, and group mean" of Level 1 and 3 for chemistry analytes. 3. Further review of the laboratory's "Determination of Target Values Multiqual Unassayed Lot # 56691/56693" document revealed the following statement "6 month re-assessment of Multiqual values based on cumulative data. 6-8-22." The document did not include the supporting raw data that included, but not limited to, the six (6) months of data assessed. 4. In interview on January 26, 2023 at 1:45 pm, Technical Consultant 2 stated he did not retain data for QC adjustments. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete written competency assessment policy for Technical Consultants. Findings: 1. Review of the laboratory's "Competency Assessment Policy" revealed the laboratory did not include performance of competency assessment for the Technical Consultants, to include, but not limited to the frequency. 2. In interview on January 26, 2023 at 11:38 am, Technical Consultant 1 confirmed the laboratory's policies did not address competency assessment for Technical Consultants. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written quality control procedure for blood culture bottles that included visual inspections. 2. In interview on January 26, 2023 at 4:33 pm, Technical Consultant 1 confirmed the laboratory did not have a procedure for visual inspections of blood culture bottles. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)