#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCELaboratory Information SystemsA Laboratory Information System (LIS) is an electronic based laboratory data system. If your lab uses aLaboratory Information System (LIS), it is important to have written policies and procedures that describesfor your staff how the LIS is utilized.You may want to address the following questions as you develop policy and procedures:• What functions does it perform?• Are there step by step instructions for staff?• Who is responsible for various functions, operation, and maintenance of the LIS?• How will data be stored, maintained, and retrieved?• What precautions are in place to protect equipment and data?The laboratory should evaluate computer processes periodically as part of its Quality Assessment Program.LIS 1 RIf the laboratory has a computer or Laboratory Information System (LIS) used to input, store, or retrieve data inrelation to activities performed in the pre-analytic, analytic, or post analytic phase of testing; is there a writtenprocedure manual available to staff?If a laboratory uses a computer or LIS, it should have a comprehensive procedure manual for its use, describinghow data is input, handled and stored, how the system is maintained, and how the systems integrity isprotected.LIS 2 RDo the procedures for the LIS include:Procedures should have sufficient detail to enable laboratory staff to perform required tasks.LIS 2.1Proper operation of LIS hardware and software?Start up and shut down sequencesLIS 2.2Data entry?LIS 2.3Generation of work lists, as applicable?LIS 2.4Validation of the accuracy of data entry and verification of accuracy of any calculations performed?This should be verified initially prior to the LIS being put into use and then assessed periodically as part ofa quality assessment review.LIS 2.5Approval or acceptance of data manually entered and/or electronically transmitted?LIS 2.6Data retrieval?LIS 2.7Reporting of test results?LIS 2.8Routine maintenance & back-up procedures?12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org