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We have a LIS staff of 3 and would like to develop a group of "superusers" from each major lab area to become more familiar / proficient in the use and functionality of our LIS system. Any comments / suggestions on how to develop such a group?

I would suggest that you contact your LIS vendor for guidance. The various LIS systems have different procedures to set up and implement “superusers”.

We are in the process of installing a new interface which will send financial transactions from our transfusion services information system to the financials system. There are 4000 tests and producats in the table. Is it necessary to validate all 4000 items? If not, how do we determine which ones and how many to validate?

Validation of software systems and the transfer of information between software systems is an important part of a quality assurance program. I’ll start by stating that it’s not necessary to include all tests and poducasts in your validation plan. Your plan should include a good sampling of tests with different testing parameters to verify that the transfer of information is accurate. Perhaps you could select normal results, abnormal results, and calculated results (if applicable) to include in your plan. CLIA doesn’t specify a number of items to test, but states that you must develop a plan and document the findings when new systems are implemented or changes are made to the software, You need to feel comfortable that the items you are testing and the number of samplestested is a fair representation of your total testing menu.

We devote significant labor resources to create/modify validation test plans and then execute the test plans each time we make a LIS version upgrade. What are the pros/cons of using automated scripting/testing software or contracted services to perform system validation procedures?

While scripting may make the validation process more efficient, it involves yet another layer of software to validate. Remember, system validation is to ensure that the software is functioning as expected. Validation of all testing phases are required. Validation of patient demographics and orders received from the EMR, validation of results at the instrument compared to the results transferred to the LIS, test calculations, rules applied by an instrument or the LIS, and then results received in the EMR will all require validation.

I would recommend human intervention, if not a totally manual method, throughout the validation process. Laboratory inspections will include review of the worksheets and printouts (if appropriate) used to validate the required information.

1. What is the CAP requirement for instrument ID for the result? Does it have to reside in the LIS or can it reside in middleware 2. Is there a standard in ASTM protocol that defines where (which line i.e.14) the instrument ID should be available from the instrument interfacefor the LIS?

The CAP GEN.43920 states that when there are two identical analyzers being used, that they be uniquely identified so that the test result can be appropriately tracked back to the instrument performing the test. The best practice is to store these data are in the LIS.



The instrument name and ID are transmitted in the ‘H’ segment of the ASTM protocol. According to the spec, this is in field 5 of the ‘H’ spec.



Excerpt from ASTM1394 spec sheet:

7.1.5 Sender Name or ID—The purpose of this field is to define the manufacturer/instrument(s) specific to this line.

Using repeat and/or component delimiters this field may reflect software or firmware revisions, multiple instrument available

on the line, etc

We are moving into a new facility which involves moving testing equipment. Do you know exactly what CLIA requires for setting upi new equipment; such as calibration, comparison studies etc before we can put instrument back in testing mode?

If there is a change in a test system, such as an analyzer , an LIS, sample handling, reporting, etc., your policies and procedures should define how performance is verified following a change. For example, after a software

update or moving an analyzer, your policy might be to run QC and 10 patient samples to verify that the results in the LIS match the results at the analyzer and the results at the LIS match the results in the EMR. Remember to save the hard copies of the validation data.