Align Laboratories Llc

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: A Follow-up survey was performed at Align Laboratories, LLC, CLIA # 19D2237799, on July 27, 2023 through July 31, 2023. Findings: Based on review of patient final reports, performance verification studies, and interview with personnel, the laboratory failed to ensure results for the antibiotic resistance gene (ABG) panel for the respiratory pathogen panel (RPP) were transmitted by the laboratory information system (LIS) accurately. Findings: 1. Review of the laboratory's performance specification studies for RPP and ABR testing revealed the laboratory did not validate the test system to report Sulfonamides. 2. Review of the following two (2) patient final test reports revealed the laboratory reported incorrect results: a) Patient RC231390012: Result for Sulfonamides was reported and discrepancy between instrument and final report results for Tetracycline. The instrument result indicated Tetracycline was "detected" (resistant), while the final report indicated "Not Detected" (non-resistant). b) Patient RC231390013: Result for Sulfonamides was reported 3. In interview on July 31, 2023, the Technical Supervisor stated she was unaware that Sulfonamides results were being reported. The Technical Supervisor confirmed the laboratory did not ensure the correct drugs and results were transmitted accurately by the laboratory's LIS. 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 -- D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: A Follow-up survey was performed at Align Laboratories, LLC, CLIA # 19D2237799, on July 27, 2023 through July 31, 2023. Based on review of the laboratory's personnel records and interview with personnel, the Technical Supervisor failed to ensure performance of a semi-annual competency assessment for Urinary Tract Infection (UTI) testing as required for two (2) of two (2) testing personnel reviewed. Findings: 1. Review of personnel records revealed the initial training for UTI testing for the Technical Supervisor (also serves as Testing Personnel) and Testing Personnel 1 were performed on October 7, 2022. 2. Further review of personnel records for the Technical Supervisor and Testing Personnel 1 revealed semi- annual competency assessments for UTI testing, due April 2023, were not performed. 3. In interview on July 31, 2023 at 9:43 am, the Technical Supervisor confirmed semi- annual competency assessments for UTI testing were not performed for the identified personnel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An Initial survey was performed at Align Laboratories, LLC, CLIA # 19D2237799, on July 14, 2022 through July 15, 2022. Align Laboratories, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 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: Based on review of the laboratory's policies, personnel records, and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency of laboratory personnel. Findings: 1. Review of the laboratory's policies and personnel records revealed the laboratory did not include frequency of performance of competency assessments and a written policy that included the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Further review of the laboratory's policies revealed the laboratory did not include a written procedure that included, but not limited to, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- monitors assessed and frequency of performance for competency assessments for Technical Supervisor and General Supervisor. 3. In interview on July 14, 2022 at 11: 30 am the Technical Supervisor confirmed the laboratory did not have written policies related to competency assessments for laboratory personnel. 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 include the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within- run, as well as, operator variance), reportable and reference range studies, sensitivity, specificity, and actions to take when data from the studies fail to meet acceptability criteria b) Reporting SARS COV-2 results, to include, but not limited to procedure, who is responsible, and frequency of reporting c) Twice a year method/instrument comparison of test results for two (2) Quant Studio instruments d) Defined storage and temperature requirement for samples e) LIS check f) Monthly Quality Assurance sample test 2. In interview on July 14, 2022 at 10:04 am the Technical Supervisor stated the laboratory did not have a written procedure for reporting COVID results to the state. 3. In further interview on July 14, 2022 at 1:37 pm , the Technical Supervisor confirmed the laboratory's procedure manual did not include the identified policies. 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)