Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on bacteriology testing records review and laboratory director interview on May 14, 2019 at 11:00 AM, it was determined that the laboratory failed to document and maintain the bacteriology testing records when 98 patients specimens for urine culture were processed and reported from March 8, 2019 to May 13, 2019. The findings include: 1. The laboratory processed patients specimens for urine culture and reports in 48 hours the following results: colony count and no growth. The positive culture were referred for microorganisms identification and susceptibility tests. 2. On May 14, 2019 at 11:00 AM, the bacteriology testing records showed that the laboratory did not document the testing records during the 24 hours and 48 hours, when 98 patients specimens for urine culture were processed and reported from March 8, 2019 to May 13, 2019. 3. The laboratory director confirmed on May 14, 2019 at 11: 00, that the laboratory did not document nor maintain the bacteriology testing records when those patients specimens were processed and reported from March 8, 2019 to May 13, 2019. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on bacteriology testing records review and laboratory director interview on May 14, 2019 at 11:00 AM, it was determined that the laboratory director failed to comply with the analytic requirement of Bacteriology specialty from March 8, 2019 to May 13, 2019. The finding includes: 1. The laboratory failed to document and maintain the bacteriology testing records when 98 patients specimens for urine culture were processed and reported from March 8, 2019 to May 13, 2019. -- 2 of 2 --