CLSI M Quality Control for Commercial Microbial Identification Systems; Approved Guideline. Final document was approved through the CLSI voting process. – Publication of CLSI M Quality Control for. Commercial Microbial. Buy CLSI M50 A Ed. 1 () Quality Control For Commercial Microbial Identification Systems from SAI Global.

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Notes The views expressed in this Commentary do not necessarily reflect the views of the journal or of ASM.

Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

Please review our privacy policy. Quality control for commercially prepared microbiological culture media; approved standard3rd ed CLSI document MA3.

Clinical and Laboratory Standards Institute. For laboratories accredited by the College of American Pathologists CAPit should be noted that the most recent version of the CAP checklist will require testing of an external control every 31 days 5. CMS states that IQCP is a new, flexible QC option that provides the opportunity to tailor QC to your unique testing environment and patients and will establish the appropriate quality practices which will reduce the likelihood of errors occurring in your laboratory.

Likewise, for commercial microbial identification systems MIS that use two or more substrates, CLIA ’88 requires QC testing with positive and negative reactivity controls for each substrate with each batch, lot number, and shipment of reagents.


Spring Meeting Summary Report Cdc-pdf. Your Alert Profile lists the documents that will be monitored. This standard is not included in any packages.

Clinical Laboratory Improvement Advisory Committee (CLIAC)

The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. This document is based on United States US regulations and will also serve as a useful resource for a wider audience.


Prepublished online Oct 7. Address correspondence to Susan E. Performance standards for antimicrobial susceptibility testing; 25th informational supplement.

CLSI MA – Quality Control for Commercial Microbial Identification Systems; Approved Guideline

Laboratory quality control based on risk management; approved guideline. One other facet of the RA is to note both the frequency of occurrence and impact of possible laboratory errors.

Likewise, daily external QC of self-contained molecular test systems that have internal controls also does not mitigate the risk of cartridge-specific errors or inadequate specimen collection. EQC primarily refers to those test systems that utilize internal controls. Already Subscribed to this document. We also understand that there are common errors in microbiology that need to be managed; however, it is difficult to see how the implementation of IQCP and the elimination of both EQC and the use of recommendations in CLSI standards and guidelines will have a positive effect for our patients.

CLIA ’67 required these large laboratories to adhere to quality control QCproficiency testing PTtest performance, and personnel standards. A discussion of the statistical considerations that support the CLSI recommendations for frequency of QC testing is available College of American Pathologists.

Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Again, c,si stated in the ASM letter to CMS, there are many tests in clinical microbiology where additional QC testing does nothing to prevent reporting erroneous results on patient’s isolates or samples.

Partially in response to public furor over deaths attributed to false-negative Pap smear readings, Congress passed the Clinical Laboratory Improvement Act of The data showed a failure rate of less than m50–a. Arch Pathol Lab Med There are three components to an IQCP: Sharpa Clxi B. Due to the refinement and advancement of MIS, this requirement has become difficult and costly for clinical microbiology laboratories and has not been shown to prevent errors when testing patients’ isolates.


Clinical Laboratory Improvement Advisory Committee (CLIAC) | DLS |CDC

The QC recommendations in the CLSI standards are supported by data demonstrating that following CLIA default QC daily testing of QC strains will not improve the quality of patient results for laboratories that have documented satisfactory performance with a specified amount of daily QC testing.

Again, following the CLSI statistically based standard cksi antimicrobial susceptibility QC testing should be sufficient, and it is unclear how the development of an IQCP will improve the quality of reporting patients’ results. To this end, our clinical microbiology community is more than willing to have its members assist CMS in this endeavor. These two options would apply to all nonwaived tests and would become effective on 1 January Facebook Twitter Email Syndicate.

Support Center Support Center. Please first verify your email before subscribing to alerts. Published online Nov Individualized quality control plan IQCP: US Statutes at Large 81 Links with this icon indicate that you are leaving the CDC website.

The clinical and anatomic pathology laboratory specialties represented include microbiology, immunology, chemistry, hematology, immunohematology, cytopathology, histopathology, genetic testing, and informatics. The views expressed in this Commentary do not necessarily reflect the views of the journal or of ASM. Clinical Laboratory Improvement Act Amendments of