Functional Requirements

LIS Interface for BacT/Alert 3D

Rev A.00

Darrel Clark
bioMérieux
Oklahoma City, Oklahoma
Dec 17, 2001

Functional Specification—LIS Interface for BacT/3D Document Rev. A.00 page 1 of 6

1. GENERAL............................................................................................................................................. 3

1.1. ORIGIN ............................................................................................................................................. 3

1.2. TEST RESULTS ............................................................................................................................... 3

1.3. “NEW” TEST RESULTS................................................................................................................. 3

2. CONFIGURATION OPTIONS (SPECIFIED IN CONFIGURATION FILE)............................... 3

3. OPERATOR INVOKED FUNCTIONS ............................................................................................. 4

3.1. REQUEST NEW TEST ORDERS FROM LIS.............................................................................. 4

3.2. SEND ALL “NEW” TEST RESULTS............................................................................................ 4

4. SUPPORTED LIS REQUEST FUNCTIONS RECEIVED BY 3D ON LIS LINK......................... 4

5. AUTOMATIC FUNCTIONS............................................................................................................... 4

6. SUPPORTED DATA FIELDS RECEIVED BY BTA 3D ................................................................. 4

7. SUPPORTED DATA FIELDS TRANSMITTED BY BTA 3D......................................................... 5

8. BACT/VIEW LIS FUNCTIONS NOT SUPPORTED....................................................................... 5

Functional Specification—LIS Interface for BacT/3D Document Rev. A.00 page 2 of 6

1. General

1.1. Origin
The LIS interface will be based on the low-level communications protocol ASTM
E1381-91 and high-level messaging protocol ASTM E1394-91. The interface
functionality is also based on the current implementation of BacT/LINK. Except for
the omission of several data fields and certain functions, the 3D implementation of
the LIS interface is designed to work fundamentally the same as the BacT/LINK
interface. It is expected that LIS configurations that work with BacT/LINK will also
work with the 3D interface with little or no modification.

1.2. Test Results

Whenever results are transmitted, the test results of all bottles belonging to the same
Hospital ID are transmitted.

1.3. “New” Test Results

When a bottle’s test result changes, and the new result is one of the selected
configuration options listed in section 1.8 below, the bottle’s test result is considered
to be “new”. When the test result for that bottle has been successfully transmitted to
the LIS, the status is no longer considered new.

2. Configuration Options (specified in configuration file)

1.4. Baud Rate: 1200, 2400, 4800, 9600, 19200
1.5. Parity: None, Even, Odd
1.6. Data Bits: 7, 8
1.7. Stop Bits: 1,2
1.8. The following criteria can be selected in any combination to define the status
changes that will cause a bottle’s test result to be considered “new”.
1.8.1. Bottle loaded.
1.8.2. Bottle goes negative.
1.8.3. Bottle goes positive
1.8.4. Bottle unloaded.

1.9. The BacT/Alert 3D can be configured to automatically request test orders at a

configurable interval.
1.10. The BacT/Alert 3D can be configured to automatically monitor the LIS
communications link. If this option is enabled, the instrument will attempt to
communicate with the LIS periodically. The interval will be configurable. If the
communications link appears to have failed, a warning message (icon) will be
displayed.
1.11. The BacT/Alert 3D can be configured to automatically transmit “new” test
results. This is preferred for LIS systems that can handle unsolicited test results.

Functional Specification—LIS Interface for BacT/3D Document Rev. A.00 page 3 of 6

3. Operator Invoked Functions

3.1. Request new test orders from LIS.

This is for LIS systems that are not capable of automatically sending test orders and
require some manual preparation before responding to a request. New test orders are
defined as test orders that have not yet been transmitted by the LIS or test orders that
require modification.

3.2. Send all “new” test results.

This is for LIS systems that are not capable of requesting test results and require
some manual preparation before receiving results. See section 1.8 above for
configuration options concerning determination of “new” test results.

4. Supported LIS Request Functions received by 3D on LIS link

1.12. Request All Results, returns test results for all bottles belonging to an
accession for which any bottle result is considered new. Note that it is assumed
that only new results are to be sent when all results are requested.
1.13. Request Results by Patient, returns test results for all bottles belonging to all
accessions associated with the patient.
1.14. Request Results by Accession, returns test results for all bottles within the
specified accession.

5. Automatic Functions
1.15. Request Test Orders from the LIS at a specified interval.
1.16. Transmit accession test results when test results change (become “new”) for
any bottle in the accession.
1.17. Monitor the LIS communication link and display a warning message (iconic)
when communications fail.

6. Supported Data Fields Received by BTA 3D

1.18. Accession Number
1.19. Bottle ID
1.20. Patient (Hospital) ID
1.21. Patient Last Name
1.22. Patient Other Name
1.23. Universal Test ID
1.23.1. Component 5, Bottle Type (Used when Bottle ID’s do not contain bottle
ID prefix.)
1.23.2. Component 6, Bottle ID
1.23.3. Component 7, Maximum Test Time (days)
1.24. Test Result
1.24.1. “+” Positive
1.24.2. “-“ Negative
1.24.3. “*” Negative to date
1.24.4. Bottle not loaded
1.25. Test Result Status

Functional Specification—LIS Interface for BacT/3D Document Rev. A.00 page 4 of 6

 1.25.1. Final (Negatives only after bottles are removed)
1.25.2. Preliminary (Positives-loaded or unloaded, negatives still loaded)
1.25.3. Incomplete (Negative to date)

7. Supported Data Fields Transmitted by BTA 3D

1.26. Accession Number
1.27. Bottle ID
1.28. Patient (Hospital) ID
1.29. Universal Test ID
1.29.1. Component 4, Test ID
1.29.1.1. “BC” for blood culture
1.29.1.2. “TTD” Time to Detection transmitted for positives in addition to
the basic result (positive, negative, etc.).
1.29.2. Component 5, Bottle Type
1.29.3. Component 6, Bottle ID
1.29.4. Component 7, Max Test Time (days)
1.30. Test (bottle) result
1.30.1. “+” Positive
1.30.2. “-“ Negative
1.30.3. “*” Negative to date
1.30.4. Bottle not loaded
1.31. Time to detection (positives only)
1.32. Test Result Status is determined as described below by the 3D. The LIS,
however, can overwrite the test result status and in this case, the 3D will return
whatever status the LIS has assigned.
1.32.1. Final (Negatives only after bottle is unloaded)
1.32.2. Preliminary (Positive-loaded or unloaded, negative still loaded)
1.32.3. Incomplete (Negative to date)
1.33. First Load Date/Time
1.34. Date/Time of positive/negative determination
1.35. Instrument Cell ID

8. BacT/VIEW LIS Functions Not Supported

This section is included to enumerate specific LIS capabilities currently available
using BacT/VIEW which will not be supported by BacT/3D.
1.36. The interface function “Request Patient Information” from the 3D to the LIS
will not be supported. All Test Orders (which includes patient information),
however, can be requested:
(1) Automatically on a periodic basis
(2) Manually at any time
(3) When Load Mode on the 3D is entered.
Supported patient information fields can be obtained by those requests.

1.37. The interface function “Request Patient Test Orders” for specified patients
will not be supported. All Test Orders for may be requested as described in the
section above.

Functional Specification—LIS Interface for BacT/3D Document Rev. A.00 page 5 of 6

 1.38. The interface function “Request Accession Test Orders” for specified
accessions will not be supported. All Test Orders for may be requested as
described in the section above.

1.39. The interface function “Send Patient Test Results” for specified patients will
not be supported. Test results for all patients may be transmitted to the LIS
• Automatically, as described in section 1.16 above
• Manually, as described in section 3.2 above.

1.40. The manual command “Send Accession Test Results” (from the 3D to the
LIS) for specified accessions will not be supported. (See Section 4.1.10
BacT/Link External Specifications A.01). Test results for all accessions may be
transmitted to the LIS
• Automatically, as described in section 1.16 above.
• Manually, as described in section 3.2 above.

1.41. Test results such as organism ID’s and smear test results cannot be
downloaded to the 3D by the LIS.

1.42. Requests from the LIS for test results specifying a range of ID’s is not
supported. The LIS may request ALL results for a patient or accession or may
request ALL new results.

Functional Specification—LIS Interface for BacT/3D Document Rev. A.00 page 6 of 6