CRITERIA FOR QUALITY LABORATORY PERFORMANCE>M 5 RIs each batch or shipment of media checked to show:• It is sterile; AND• Supports, selects, or inhibits bacterial growth, (as appropriate based on type of media), OR• Has the biochemical reactivity that is expected?Documentation available to show that the manufacturer has checked these specifications according to the standardsof the Clinical Laboratory Standards Institute (CLSI formerly NCCLS) can satisfy this requirement.If your manufacturer has already checked the media in accordance with CLSI standards and states so in thepackage insert or by letter, the laboratory does not have to repeat these checks. This exception does notinclude:• Chocolate agar,• Campylobacter media, and• Selective media for the isolation of Neisseria species.These must be controlled upon receipt in the laboratory due to a high percentage of failure during shipment.M 6 RAre media visually inspected before use?The general condition of media should be checked upon receipt. Record this check and any action taken inyour records. Media should also be checked for the absence of growth prior to inoculation. The absence ofgrowth upon visual inspection of media prior to culture inoculation may also be recorded.M 7 RDoes the laboratory report any deteriorated or substandard media to the manufacturer?If any problems are noted, you should report the problem to your supplier. Record any actions taken in yourrecords.M 8 RWhere applicable, are positive, negative, and graded reactivity checked with each batch, lot number and shipmentof microbiology reagents, discs, stains, and anti-sera when prepared or opened?Whether these reagents are prepared in house or purchased commercially, the laboratory must verify properreactivity prior to or concurrent with patient testing.If performed concurrent with patient testing, and results are not as expected, the patient test may not bereported and must be repeated once the problem has been identified, resolved, and acceptable performancehas been verified.> NOTE: For a number of reagents there are ongoing QC requirements further specified in the microbiologysubspecialty sections. Please refer to BA 3-5.M 9 RAre positive and negative or graded reactivity checked with each batch, lot number and shipment of identificationsystems when prepared, received, or when first opened?This category includes all biochemical identification systems, either single or combinations of tests for anorganism, and systems, such as API strips or Microscan panels. It also includes pre-packaged media combinationssuch as Uricult or Bullseye, when they are used for presumptive identification of microorganisms.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org41
CRITERIA FOR QUALITY LABORATORY PERFORMANCEIf these systems are used to report presumptive identification of organisms, the key components, uponwhich the laboratory’s level of identification is based, needs to be validated to give appropriate reactions inthe presence of known organisms.In some cases it may not be feasible to maintain a complete cadre of organisms to be able to establish bothpositive and negative reactivity for every potential component used by the system to make identification.The laboratory must challenge the system with the organisms suggested by the manufacturer, commonlyavailable, easily maintained, and that represent those organisms most commonly identified among the laboratory’spatient population.M 10 RDoes the microbiology record, for each sample, include documentation of the reactivity noted for each step ofthe identification process?This documentation will vary based on the identification system in use. It should enable staff to look backand verify that the identification reported based on the reactions observed is valid. Common items to includein documentation are: growth characteristics on various media, positive or negative reactivity with variousstain, reagents, or disks. This documentation provides valuable information if there is a question later aboutthe interpretation of results that lead to identification of a specific organism on the final report.42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT <strong>COLA</strong> PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org