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 from year 2018 to 2019 and interview with the bacteriology supervisor and laboratory director on March 20, 2019 at 2:00 P.M. it was determined that the laboratory failed to ensure compliance with the analytic system requirements of bacteriology. The finding includes: 1. The laboratory failed to check each day of testing the antimicrobial susceptibility tests . Refer to D5507. 2. The laboratory did not take nor document any correction action when the incubator temperature was out of range. Refer to D5781. 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: 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 -- Based on bacteriology quality control records review, and bacteriology technical supervisor interview at 2:00 P.M. on March 20, 2019 , it was determined that the laboratory failed to check each day of testing the antimicrobial susceptibility tests . The findings include: 1. The laboratory begin to use the Microscan DxM 1096 system on February 12, 2019. 2. The bacteriology quality controls records ( antimicrobial susceptibility tets) showed that the laboratory did not check each day of testing the antimicrobial susceptibility tests when specimens antimicrobial susceptibility were tested from February 12, 2019 to March 19, 2019. 3. The laboratory performed and reported 3.000 patients specimens antimicrobial susceptibility tests for gram negative organism and for gram positive organism since February 12, 2019. 4. The laboratory performed weekly the antimicrobial susceptibility tests quality control procedures. 5. The bacteriology technical supervisor confirmed on March 20, 2019 at 2:00 P.M., that the laboratory did not check each day of testing the antimicrobial susceptibility tests. D5781