Summary:
Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Bacteriology quality control records review ( 2022-2023 ) and interview with the laboratory testing personnel, laboratory general supervisor and laboraory director on September 7, 2023 ay 1:00 P.M., it was determined that the laboratory failed to ensure compliance with the analytic system requirements of bacteriology. Refer to D5507 (the laboratory did not perform quality control procedures for susceptibility tests each day of testing). D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on bacteriology quality control records review , testing personnel and 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 -- laboratory director interview on September 8, 2023 at 12:30 P.M. , it was determined that the laboratory failed to check each day of testing with the appropriate control organisms the antimicrobial susceptibility tests were performed. The findings include: 1. The bacteriology quality control records showed on September 8, 2023 at 12: 30 P. M.that the laboratory did not check with the appropriate control organisms the antimicrobial susceptibility tests when patients specimens antimicrobial susceptibility were tested from may 2023 to august 2023. 2. The laboratory performed and reported 12 patients specimens antimicrobial susceptibility tests for gram negative organism and 2 patients specimens antimicrobial susceptibility tests for gram positive organism. 3. The testing personnel stated on september 8, 2023 at 12:40 P.M. , that the laboratory did not check daily the susceptibility tests. She stated that the laboratory checked monthly the susceptibility tests quality control procedures. D5781