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CA 2: Test Preparation, LIMS Processing, Test Results Recording and Verification

This capability area addresses informatics capabilities related to the business processes associated with initial sample test request and receiving.

Guidance Statement

Purpose: A critical function of an environmental, clinical, or public health laboratory is to receive requests for laboratory testing from an authorized submitter, process them and validate the results obtained, then issue reports to the submitter; and, when required, submit results reports to a local or state or federal public health agency. Traditionally, such requests and reports were exchanged manually, in paper form, via fax, email, or by postal service. Computerized LIMS with the capability to securely transfer encrypted request and result messages between data systems via national standard messaging formats, codes and terms, can achieve significant efficiencies in accuracy, time, and cost.

What: This capability area addresses test preparation, LIMS processing, test results recording and verification, and the progress achieved in implementing data system interoperability (i.e., the ability to receive test requests, verify and return test results and forward laboratory reports for notifiable diseases to public health agencies using secure electronic messaging).

How: The process of moving from an entirely paper-based work flow system to a secure electronic work flow system using standard messaging formats, codes, and terms can be a lengthy one requiring careful planning and staging of activities. Availability of resources to carry out this process also influences the timeline for achieving full interoperability.

A laboratory that has the desired informatics capabilities to efficiently manage the process for sample receiving and test requests can:

  • Receive samples and associated electronic test requests from submitting laboratories and can perform pre-processing of the sample for testing individually, or in batches, through LIMS and integrated systems.
  • Assign one or more samples to individual tests or combinations of tests, instruments, runs and batches, prepare test queue, and prioritize through LIMS and/or other integrated systems.
  • Populate test results data [sample and Quality Control (QC)1] from instruments back into LIMS through a seamless integrated process.
  • Send test order data from LIMS to an instrument in an automated manner.
  • Perform verification for QC and test results for individual samples or batches within the LIMS and report QC parameters through the LIMS.
  • Automatically flag and auto-assign tests to samples that need retesting (individual or batch), and review and update samples and their results through the LIMS.
  • Auto-assign reflex testing to samples either individually or in a batch.
  • Track reports created, the receiver of the report, the version it was created in, and maintain those logs.
  • Export all sample associated data in flexible formats for further manipulation and analysis.
  • Grant users permission by laboratory sections, to approve, edit (amend and correct), and view a report.
  • Block electronic messaging for samples which should not be reported (e.g., proficiency samples, and validation samples).

Capability Statement #2.1

Capability Statement Level Description of Level
Capability Statement #2.1 The laboratory is able to receive samples and associated electronic test requests from submitters (including other laboratories) and can perform pre-processing2 of the samples for testing individually or in batches through the LIMS and integrated systems. Level 3 The laboratory is able to perform these functions electronically through the LIMS and integrated systems.
Level 2 The laboratory is able to perform some of these functions electronically.
Level 1 The laboratory uses a paper-based system to perform these functions.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.2

Capability Statement Level Description of Level
Capability Statement #2.2 The laboratory is able to assign one or more samples to individual or combinations of tests, instruments, runs and batches4, prepare test queue, and prioritize through the LIMS and/or other integrated systems. Level 3 The laboratory is able to perform these functions through the LIMS and/or other integrated systems.
Level 2 The laboratory is able to perform some of these functions electronically.
Level 1 The laboratory uses a paper-based system to perform these functions.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.3

Capability Statement Level Description of Level
Capability Statement #2.3 The laboratory is able to populate test results data (sample and QC1) from instruments back into LIMS through a seamless integrated process. Level 3 The laboratory is able to electronically receive both sample and QC results in their LIMS.
Level 2 The laboratory is able to electronically receive sample results but not QC.
Level 1 The laboratory enters sample and QC results manually.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.4

Capability Statement Level Description of Level
Capability Statement #2.4 The laboratory’s LIMS is able to build an analytical sequence for instrument integration (e.g., create run queue for the instrument and upload it to the instrument). Level 3 The laboratory is able to perform this function.
Level 1 The laboratory is unable to perform this function.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.5

Capability Statement Level Description of Level
Capability Statement #2.5 The laboratory is able to perform verification for QC and test results for individual samples or batches within LIMS and send QC parameters and instrument name to LIMS from the instrument. Level 3 The laboratory is able to perform these functions.
Level 2 The laboratory is able to perform some of these functions.
Level 1 The laboratory is unable to perform these functions.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.6

Capability Statement Level Description of Level
Capability Statement #2.6 The laboratory is able to automatically flag and auto assign tests to samples that need retesting (individual or batch) and can review and update samples and results through the LIMS. Level 3 The laboratory is able to perform these functions through the LIMS.
Level 1 The laboratory is unable to perform these functions through the LIMS.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.7

Capability Statement Level Description of Level
Capability Statement #2.7 The laboratory is able to auto-assign reflex or repeat testing5 to samples either individually or in a batch Level 3 The laboratory is able to perform this function.
Level 1 The laboratory is unable to perform this function.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #2.8

Capability Statement Level Description of Level
Capability Statement #2.8 The laboratory is able to identify samples received for individual patients and maintain a local master patient index that can be used to detect discrepancies and support ongoing treatment management and monitoring efforts of public health submitters. Level 3 The laboratory maintains a master patient index for samples where it is appropriate to do so, and can automatically detect potential matches and discrepancies.
Level 2 The laboratory maintains a master patient index for samples where it is appropriate to do so.
Level 1 The laboratory is not able to electronically identify multiple samples for individual patients.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules
capability_2.txt · Last modified: 2016/12/30 20:59 by awake