Summary:
Summary Statement of Deficiencies D0000 A complaint survey was performed on August 26, 2021, based on a complaint intake (AL00039614) on 07/20/2020. The complaint included the following allegations: a) No maintenance procedures b) No Quality Control procedures c) No training policies d) No cleaning e) Cyber security issues f) No job descriptions g) No written procedures As a result of this complaint investigation, the following deficiencies were cited: a) The laboratory failed to verify the accuracy of test procedures when proficiency testing is unavailable (Refer to D5217). b) The laboratory's procedure manual failed to include a procedure describing its current practices of entering results and reporting patient results in 2020 to 2021 (Refer to D5403). c) The laboratory failed to perform maintenance on its instrumentation, according to the manufacturer's guidelines (Refer to D5429). d) The Laboratory Director failed to ensure his approval of the procedure manual, as would be evidenced by his signature (Refer to D5407). e) The Laboratory Director failed to ensure the laboratory was performing semi-annual and/or annual competency assessments for new testing personnel (Refer to D6107). . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of External Lab Cross Comparison records, Policy and Procedure Manual - Proficiency Testing, and an interview with the Technical Supervisor, the laboratory failed to verify the accuracy of test procedures when Proficiency Testing is unavailable. This was noted for 2021 for NTRK (Neurotrophic Tyrosine Receptor Kinase), PD-L1 (Programmed Death - Ligand 1), and ALK-ROS1 (Anaplastic lymphoma kinase c-ros oncogene 1). The findings include: 1. A review of External Lab Cross Comparison records revealed the following: a.) Proficiency, NTRK Gene Fusion Test i.) September 2020 - Three samples sent to Foundation Medicine for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- comparison. ii.) March 2020 - Three samples sent to Foundation Medicine for comparison. b.) ProGenetics, Proficiency, PD-L1 Test i.) September 2020 - Three samples sent to Liquid Genomics for comparison. ii.) March 2020 - Three samples sent to Liquid Genomics for comparison. iii.) October 2019 - Three samples sent to Liquid Genomics for comparison. iv.) April 2019 - Three samples sent to Liquid Genomics for comparison. c.) Proficiency, ALK-ROS1 Gene Fusion Test i.) September 2020 - Three samples sent to Biodesix for comparison. ii.) March 2020 - Three samples sent to Biodesix for comparison. iii.) November 2019 - Three samples sent to Biodesix for comparison. iv.) March 2019 - Three samples sent to Biodesix for comparison. d.) Promega, Proficiency, MSI Test - Moved to Proficiency Testing in November 2020. i.) March 2020 - Three samples sent to Thermo Fisher for comparison. ii.) December 2019 - Three samples sent to Thermo Fisher for comparison. iii.) April 2019 - Three samples sent to Thermo Fisher for comparison. 2. A review of Policy and Procedure Manual - Proficiency Testing (Doc #: QS - 076) revealed under 5.1.2 Proficiency Testing Unavailable " ...5.1.2.2 In the event a proficiency testing program is not available, CirculoGene will send specimens to an external lab for accuracy comparison purposes ..." 3. During an interview on 08/26 /2021 at 10:40 AM, the Technical Supervisor stated accuracy comparisons had not been performed in 2021. 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)