When building an Autoverification Rule Set it’s common to include evaluation rules for Clinical Ranges. These rules typically set test reference ranges, abnormal flags, critical ranges, and critical flags for each test result according to your laboratory’s established ranges.

Many labs have established ranges for certain analytes which also take into account the patient’s Sex and Age. These patient demographics are typically provided to Instrument Manager (IM) in the LIS Test Order. However, there are some instruments which may also provide Sex and/or Age patient demographics to IM within the results message which may overwrite the information from the original LIS Test Order. If the Sex and/or Age sent from the instrument, in the result message, are incorrect, this could have a direct effect on Sex and/or Age based evaluation rules for Clinical Ranges in terms of applying the correct test ranges and flags for that patient’s test.

When constructing evaluation rules for Clinical Ranges, it is highly recommended that this possibility be taken into consideration. As a precaution, ensure that the ‘Overwrite Patient Data’ option in the Connection Configuration, for the instrument connection, is set to unchecked. . In addition, it’s also recommended that the Overwrite Patient Data setting is set to unchecked on ALL instrument connection configurations if patient demographics from the instrument are not required to populate IM Patient Demographics. The ‘Overwrite Patient Data’ option is a feature available on IM Version 8.14.10 or greater.

For customers on an IM Version prior to version 8.14.10 an Incoming Result rule which qualifies the Patient Sex and Age prior to result evaluation is highly recommended to be included as part of your evaluation rules for Clinical Ranges:

Incoming result – Before Message Queued Internally which includes a Hold all Tests Rule in instrument configuration to verify Age in Days is populated and Sex matches an expected value from the LIS order (for example, “M” or “F” are the defined Sex types configured in the LIS vs blank or “U”).

• This helps ensure Clinical Ranges Evaluation Rules which evaluate Sex and Age function as expected on test results
• If an unexpected value is present the rules will hold all results for further evaluation.

EXAMPLE RULE:
If: ( {Test Resulted} “WBC” ) {AND} ( ( ( {Sex} {NOT} = “M” ) {AND} ( {Sex} {NOT} = “F” ) ) {OR} ( {Patient Age in Days} = “” ) )
Then: {Hold all Tests for Verification} {AND} {Set} {Specimen Comment(s)} = “DO NOT REPORT – VERIFY AGE & SEX”
Else:

Important: It is critical that Rules be validated by the user to ensure that the Rules function as they are intended prior to being moved into the Live Rule set and put into practice in the laboratory setting. Refer to the Instrument Manager Rules Manual for additional recommendations regarding testing.

Data Innovations Technical Professional Service Team is available to assist customers with specific rules development and/or evaluation. For more information, please contact northamerica-sales@datainnovations.com or call 802.658-2850.

For questions related to the ‘Overwrite Patient Data’ option, the rules noted here or Instrument Manager Rules in general, please contact support at northamerica-support@datainnovations.com or call 802.658.1955.

Resources:

• Instrument Manager – Rules Manual (included with Instrument Manager software).
• Instrument Manager – Getting Started Setup Guide (included with Instrument Manager software).