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capability_3

CA 3: Report Preparation and Distribution

This capability area addresses informatics capabilities related to electronic report preparation, electronic submission of test results, and auxiliary data report format and content, transport and distribution, and tracking.

Guidance Statement

Purpose: In order to meet the needs of their clients, PHLs are expected to provide valid and relevant results rapidly, and package these results for electronic consumption [e.g., for electronic health records (EHRs) within hospitals]. The ability to meet these needs depends on having a LIMS capable of providing the information electronically, the technical infrastructure necessary to package and transmit the results securely, and the skills to implement and manage that process.

What: This capability area assesses the ability to meet the typical electronic delivery needs of most PHLs. These capabilities are dependent on a laboratory’s level of implementation of pre-analytical steps from CA 1 and CA 2. In addition to collection, storage, and retrieval of analytical test result data and additional data to support validation (e.g., quality control data for some tests), the laboratory collects and stores associated client-specific metadata and auxiliary data. These data must be available in an electronic format before they are added into the results message. While it is helpful to be able to “begin with the end in mind” when implementing data exchange technologies, often this may be difficult, as many PHL clients have different and evolving electronic data “end” requirements. Until more universal standardization of PHL data occurs, the PHL’s capability to meet multiple data consumer needs may depend on its ability to address different electronic data message formats, vocabularies, and transport mechanisms as needed.

How: A PHL can benefit greatly from the use of an “interface engine” between its LIMS and external clients. This interface engine provides the PHL with the ability to scale its messaging infrastructure according to its needs, and insulate its LIMS from the security and performance hazards of having messaging functionality coupled with LIMS functionality.

In addition, the ability to exchange an electronic results message in the correct format requires personnel with special skill sets that include messaging and vocabulary. This exchange often includes partnership between laboratory and informatics SMEs who are capable of understanding the results well enough to translate them into their electronic format correctly and without loss of important detail. Many laboratories have found it beneficial to invest in training of laboratory staff to specialize in this area and obtain the necessary skills and experience.

A laboratory that has the desired Informatics capabilities related to report preparation, electronic submission of test results, report validation, distribution, and tracking, can:

  • Create an electronic message for test results using agreed-upon standards and vocabulary for message creation.
  • Send an electronic message for test results using agreed-upon standards and vocabulary for message transmission.
  • Receive an acknowledgement about delivery of the electronic message using agreed-upon standards and vocabulary for message receiving.
  • Electronically modify and verify submitters and data requestors authorized to receive results by referencing a test/data requestor index.
  • Modify and verify submitters and data requestors authorized to receive results through LIMS and keep a log of submitters.
  • Comply with submitters’ data exchange format requirements for electronic results submittal and reporting based on different business rules.
  • Submit results via a secure electronic message format.
  • Electronically submit results of tests performed on the sample to recipients.
  • Electronically authenticate test results.

Capability Statement #3.1

Capability Statement Level Description of Level
Capability Statement #3.1 The laboratory is able to create an electronic message for test results using agreed-upon standards and vocabulary for message creation. Level 3 The laboratory is able to perform this function.
Level 2 The laboratory is able to perform this function on a limited basis.
Level 1 The laboratory is unable to perform this function.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.2

Capability Statement Level Description of Level
Capability Statement #3.2 The laboratory is able to send an electronic message for test results using agreed-upon standards and vocabulary for message transmission. Level 3 The laboratory is able to send a new or ad hoc electronic message for test results using agreed-upon standards and vocabulary.
Level 2 The laboratory is able to perform this function on a limited basis using some of the agreed upon standards and vocabulary.
Level 1 The laboratory is unable to perform this function.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.3

Capability Statement Level Description of Level
Capability Statement #3.3 The laboratory is able to receive an acknowledgement of delivery of the electronic message using agreed-upon standards and vocabulary for message receiving. Level 3 The laboratory is able to perform this function.
Level 2 The laboratory is able to perform this function on a limited basis using some of the agreed-upon standards and vocabulary.
Level 1 The laboratory is unable to perform this function.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.4

Capability Statement Level Description of Level
Capability Statement #3.4 The laboratory is able to route results electronically to requestors other than original submitters based upon test results. Level 3 Yes
Level 1 No
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.5

Capability Statement Level Description of Level
Capability Statement #3.5 The laboratory maintains an electronic log of receivers of test results. Level 3 Yes
Level 1 No
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.6

Capability Statement Level Description of Level
Capability Statement #3.6 The laboratory is able to comply with submitters’ data exchange format requirements for electronic results submittal and reporting based on different business rules. Level 3 The laboratory is able to comply with submitters' data exchange format requirements for electronic results submittal and reporting based on different business rules.
Level 2 The laboratory is able to comply with some of the data exchange and reporting format requirements of submitters.
Level 1 The laboratory is unable to comply with submitters’ data exchange format requirements.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.7

Capability Statement Level Description of Level
Capability Statement #3.7 The laboratory is able to electronically submit results of all tests performed on a particular sample or patient to recipients. Level 3 The laboratory is able to electronically submit results of all tests performed on a particular sample or patient to recipients.
Level 2 The laboratory is able to electronically submit results for some tests performed on that sample to recipients, but cannot include results of any previous testing done on the patient.
Level 1 The laboratory is only able to submit results manually and/or by fax/mail.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.8

Capability Statement Level Description of Level
Capability Statement #3.8 The laboratory is able to track reports created, the receiver of the report, time of transmission, and version it was created in, and maintain those logs. Level 3 The laboratory is able to perform all these functions for the workflow of the report generation and transmission process.
Level 2 The laboratory is able to perform some of these functions for the workflow of the report generation and transmission process.
Level 1 The laboratory is able to track reports through disparate paper-based systems
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.9

Capability Statement Level Description of Level
Capability Statement #3.9 The laboratory is able to export all sample associated data in flexible formats for further manipulation and analysis. Level 3 The laboratory is able to export all sample associated data in flexible formats for further manipulation and analysis.
Level 2 The laboratory is able to export some sample associated data (e.g., results and some QC data or metadata) in a limited number of formats.
Level 1 The laboratory cannot export data in specified/ desired formats.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.10

Capability Statement Level Description of Level
Capability Statement #3.10 The laboratory is able to grant users permission by laboratory sections to approve, edit (amend and correct), and view a report Level 3 The laboratory is able to grant users permission by laboratory sections to approve, edit, and view a report.
Level 2 The laboratory is able to grant internal users permission to view reports but not to approve or edit.
Level 1 The laboratory cannot grant permissions.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #3.11

Capability Statement Level Description of Level
Capability Statement #3.11 The laboratory is able to filter out electronic messaging for samples that should not be reported (e.g., proficiency samples, validation samples). 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_3.txt · Last modified: 2016/12/30 21:54 by awake