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SMILE Johns Hopkins University Baltimore, MD USA Verification Plan for New Mycobacteriology Drug Susceptibility Testing Method Author: Peggy Coulter Review History Document Number: Effective (or Post) Date: Date of last review: Reviewed by: Equ35-L-05 7-July-11 13-Feb-12 Heidi Hanes SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE. SMILE Document Mycobacteriology Testing Verification Template 27 June 2011 Insert Lab Header here Include full name and address of Lab Verification Plan for New Mycobacteriology Drug Susceptibility Testing Method Method being verified: The verification will be conducted on the insert method. This is a qualitative mycobacteriology method. Preparation I. SOP Development: Include target dates for the development, review and implementation of SOP for the new mycobacteriology method. An SOP that outlines the procedure for the insert method being verified will be prepared and reviewed by insert target date. II. Training and Competency: Include a timeline for staff training and competency assessment of staff members performing the verification. Training must be complete before evaluation data is collected. Proficiency must be demonstrated in sample handling and storage, proper test protocol and, interpretation of results and quality control of the system. Competency must be determined initially for responsible staff performing the verification procedures and interpreting the results. Training and competency will be performed and assessed by (describe how training will be performed and how competency will be assessed). Training and competency assessment will be completed by insert target date. Verification I. Selection of specimens Specimen Options: Cover the spectrum of organisms expected to be encountered. • Materials with assigned values (EQA events) • Patient specimens a. Shared with another accredited laboratory. b. Shared with a reference laboratory c. Shared between two in-house methods d. Saved from previously identified cultures • Outside sources a. ATCC strains b. National programs II. Number of specimens: A minimum of 5 isolates using the new method for precision of each antimycobacterial agent. A minimum of 30 specimens for categorical agreement as compared to the reference method on each antimycobacterial agent Verification will be performed using (include number of specimens and selected sample options). SMILE Document Culture Verification Template 3 June 2011 Insert Lab Header here Include full name and address of Lab Calculations I. Precision (Reproducibility) - the agreement of the measurements of replicate runs of the same sample. It is the process of determining the range of random error. Precision will be determined by testing a minimum of 5 isolates in triplicate for 3 days for each antimycobacterial agent. Precision Calculation: Precision % = number of repeated results in agreement/ total number of results X 100 II. Categorical Agreement (CA) %- agreement with interpretive results of sensitive, intermediate and resistant (S/I/R), as applicable. Categorical Agreement Calculation: Categorical agreement % = number of categorical results/matches/ total number tested X 100 Criteria for acceptability Acceptable precision results must be >95%. Categorical agreement must be > 90%. All categorical errors must be investigated. If the precision or categorical agreement of the new test does not satisfy the verification requirements, the test will be considered unverified and corrective action must be taken by the manufacturer, the laboratory, or both. Following corrective action the new or revised test will be run again in parallel with the reference method and interpreted. Method Approval The final decision on methodology verification and acceptance is made after a careful review of all the studies performed as part of the complete process. The Laboratory Director shall make the ultimate decision on method verification. Method acceptance is based on the results from the above studies plus an evaluation of the new method’s cost effectiveness, turn-around-time, laboratory staff training needs, and any other relevant operational considerations. Conclusion SMILE Document Culture Verification Template 3 June 2011 Insert Lab Header here Include full name and address of Lab Include a brief conclusion for additional notes on the process and statistical calculations to justify final approval of the new method. References SMILE Document Culture Verification Template 3 June 2011