Scientific Research Consortium, Inc

Summary Statement of Deficiencies 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: . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to ensure 4 of 5 testing personnel received a competency evaluation at least semiannually during the first year of patient specimen testing. Findings are as follows: 1. The laboratory performed Amino Acid and Fatty Acid Analysis under the subspecialty of Chemistry as confirmed by Testing Supervisor 2 (TS2) and Testing Supervisor 3 (TS3) during the entrance interview and tour of the lab at 10:05 a.m. on 09/24/20. 2. Testing Personnel 3 (TP3), Testing Personnel 4 (TP4), Testing Personnel 5 (TP5) and Testing Personnel 6 (TP6) were listed on the Laboratory Personal Report (CLIA) Form CMS-209 as high complexity testing personnel. 3. Semiannual competency assessment were not found for 4 of 5 testing personnel (TP3, TP4, TP5, TP6) during review of laboratory personnel records. The laboratory was unable to provide a semiannual competency assessment for the testing personnel upon request. 5. In an interview at 9:15 a.m. on 09/24/20, TS3 confirmed the above findings. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to document the time specimens for lipid testing were received into the laboratory. Findings are as follows: 1. The laboratory performed lipid testing under the Specialty of Chemistry as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 04/19/18 at 10:05 a.m. 2. Requirements for documentation of specimen receipt time into the laboratory were found in the Sample Receipt, Storage and Disposal procedure located in the SOP manual.. 3. The time of specimen receipt into the laboratory was not documented in the lipid electronic receipt record reviewed on date of survey. 4. In an interview on 04/19/18 at 1:10 p.m., the General Supervisor confirmed the time of lipid specimen receipt was not documented. 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)