CSF: 7.1.6 Wound: 7.1.7 Genital: 7.1.8 7.1.9 Throats: 7.1.10 (specify): 7.1.11 Media 7.2 Are there instructions to indicate the number and 7.2.1 types of media and method of inoculation required? Does the laboratory have documentation that its 7.2.2 media supplier carries out the quality assurance guidelines as per CLSI document M22-A3? Does the laboratory have documentation that the purchased media that are not listed in M22-A3 as exempt from testing is checked for each of the 7.2.3 following: Ability to support growth by means of stock cultures or by parallel testing with previous batches? Biochemical reactivity (where appropriate)? 7.2.4 For media prepared in-house, is there documentation that it is checked for each of the 7.2.5 following: Sterility (following introduction of additives after sterilization)? Ability to support growth by means of stock 7.2.6 cultures or by parallel testing with previous batches? Biochemical reactivity (where appropriate)? 7.2.7 8.0 GYNECOLOGICAL SPECIMENS Are B streptococcus screens collected and 8.1 cultures from pregnant women in accordance with current guidelines? DETECTION OF SEXUALLY 9.0 TRANSMITTED PATHOGENS Are culture conditions optimal for isolation of 9.1 Neisseria gonorrhoeae? If Neisseria gonorrhoeae isolated, is 9.2 being tested and reported? Are culture facilities or NAAT methods 9.3 available locally or via a reference laboratory for the detection of Chlamydia trachomatis?
7.1.6 CSF: 7.1.7 Wound: 7.1.8 Genital: 7.1.9 7.1.10 Throats: 7.1.11 (specify): 7.2 Media 7.2.1 Are there instructions to indicate the number and types of media and method of inoculation required? 7.2.2 Does the laboratory have documentation that its media supplier carries out the quality assurance guidelines as per CLSI document M22-A3? 7.2.3 Does the laboratory have documentation that the purchased media that are not listed in M22-A3 as exempt from testing is checked for each of the following: Ability to support growth by means of stock cultures or by parallel testing with previous batches? 7.2.4 Biochemical reactivity (where appropriate)? 7.2.5 For media prepared in-house, is there documentation that it is checked for each of the following: Sterility (following introduction of additives after sterilization)? 7.2.6 Ability to support growth by means of stock cultures or by parallel testing with previous batches? 7.2.7 Biochemical reactivity (where appropriate)? 8.0 GYNECOLOGICAL SPECIMENS 8.1 Are B streptococcus screens collected and cultures from pregnant women in accordance with current guidelines? 9.0 DETECTION OF SEXUALLY TRANSMITTED PATHOGENS 9.1 Are culture conditions optimal for isolation of Neisseria gonorrhoeae? 9.2 If Neisseria gonorrhoeae isolated, is being tested and reported? 9.3 Are culture facilities or NAAT methods available locally or via a reference laboratory for the detection of Chlamydia trachomatis?
CRA-F-05-15189-S-08-Microbiology%20Inspection%20Checklist.docx