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LIS Interface
Specification
This document describes the specifications for the transfer of data between the Echo instrument
and a Laboratory Information System (LIS).
• Detailed list of contents
• Scope
• Definitions
• Connectivity
• Communication
• Echo ASTM message structure
• Echo ASTM record structure
• Examples
• References
Scope
This document describes the specifications for the transfer of data between the Echo instrument
and a Laboratory Information System (LIS). To ensure industry standardization, the Echo follows
LIS1-A – Standard Specification for Low-Level Protocol to Transfer Messages between Clinical
Laboratory Instruments and Computer Systems (formerly ASTM E1381-02) for electronic data
transmission and incorporates LIS2-A2 – Specification for Transferring Information between
Clinical Laboratory Instruments and Information Systems (formerly ASTM E1394-97) for the
structure of the data being transferred.
Definitions
Field – One specific attribute of a record that may contain aggregates of data elements further
refining the basic attribute.
Component field – A single data element or data elements that express a finer aggregate or an
extension of data elements that precede it.
Message – A textual body of information consisting of a header (H) record through a message
terminator (L) record.
Record – An aggregate of fields describing one aspect of the complete message.
Download – Data transmitted from a computer system (LIS) to a clinical instrument (Echo).
Upload – Data transmitted from a clinical instrument (Echo) to a computer system (LIS).
Connectivity
Two methods of connectivity are supported by the Echo—serial transfer and TCP/IP socket
transfer. This section describes both methods, each of which supports the LIS1-A low-level
communication protocol.
Serial
Serial connection to the Echo instrument is made using a DB-9 pin connector. Table 1 describes
the connector contact assignments.
Direction
Contact No. EIA Circuit Description Instrument LIS
1 … Shield … No Connection
2 BA Transmitted Data Output Input
3 BB Received Data Input Output
5 AB Signal Ground … …
Table 1 – Connector Contact Assignments for RS 232 D Serial Binary Data Exchange
The default serial communication port is COM2, and it uses the defaulted settings described in
Table 2.
The serial mode of operation is a one-way transfer of information with alternate supervision.
Information flows in one direction at a time. Replies occur after information is sent, never at the
same time. It is a simplex stop-and-wait protocol.
TCP/IP
The Echo uses a standard RJ-45-style connector for TCP/IP communication. Detailed
requirements of an interconnecting cable are not defined, but good engineering practice should
be followed in selecting the cable and connectors. Low-capacitance cable and shielded
connectors may be necessary to suppress electromagnetic interface (EMI). Appropriate
connector locking hardware should be used at the conforming connectors.
The data transmission rate for the Echo conforms to a speed of 100Mbps.
The standard framework for TCP/IP network implementation is generally referred to as “socket”
implementation. The normal implementation of a socket-based communication protocol is
asymmetric. One end is considered a “server” providing service to the other end, which is
considered a “client.” Under this client/server paradigm, the LIS is defined as the “server” and
the Echo is defined as the “client.” Both must initially create sockets and bind their local Internet
addresses to their socket. The LIS, as the server, offers a socket for connection. The Echo, as
the client, is independently configurable for both socket and IP address (to facilitate use of
server-defined socket numbers and IP addresses), and requests a connection to the offered
socket.
Due to the harmful nature of viruses, worms, and other network anomalies, it is strongly
recommended that a firewall device be placed between the Echo instrument and the facility
network to protect against the malicious threats of networking. The Echo instrument connects to
the firewall device, which in turn is connected to the facility network. A firewall device is a
hardware component that will restrict access between the Echo instruments and the facility
network to block unwanted use or abuse, and a firewall is only necessary for Ethernet (TCP/IP)
connectivity. The Cisco PIX® 501 is the recommended device to be implemented.
Communication
Serial and TCP/IP Data Transfer
There are three distinct phases in transferring information between the Echo instrument and the
LIS. In each phase, one system directs the operation and is responsible for continuity of the
communication. The three phases assure that the actions of the sender and the receiver are
coordinated. The three phases are establishment, transfer, and termination. Although they are
briefly described here as an overview, the LIS-1A specification should be reviewed for complete
details. Any variance of the LIS-1A specification is described in the following section.
At no time will the Echo respond to unsolicited messages. The expectation is that messages
containing order information will follow a query made to the LIS. The Echo will maintain the
connection in an active state for 15 seconds following a query to allow for a reply. After this time
is elapsed, the Echo no longer monitors the data link state.
Transfer Phase
During the transfer phase, the Echo transmits and receives messages to and from the LIS. The
transfer phase will continue until all messages are sent. Messages are sent and expected to be
received in frames, with each frame containing a maximum of 247 characters. Messages longer
than 240 characters are divided between two or more frames. Every message must begin a new
frame. A frame is one of two types—an intermediate frame or an end frame. The frame structure
is illustrated in Table 3; however, further explanation on the structure of the frame, including how
the frame number and checksum are calculated, can be found in the LIS1-A specification.
Where
<STX> Start of Text transmission control character
FN Single digit Frame Number 0 to 7
Text Data Content of Message
<ETB> End of Transmission Block transmission control character
<ETX> End of Text transmission control character
C1 Most significant character of check sum 0 to 9 and A to F
C2 Least significant character of checksum 0 to 9 and A to F
<CR> Carriage Return ASCII character
<LF> Line Feed ASCII character
Table 3 – Frame Structure
The Echo follows the rules outlined for acknowledgements to each frame. An <ACK> signifies
that the last frame was received successfully and indicates readiness to receive another frame. A
<NAK> signifies that the last frame was not successfully received and indicates readiness to
receive the frame again. An <EOT> signifies the last frame was received successfully, but an
interrupt is requested.
Data Characters
All data will be represented as eight-bit, single-byte, coded graphic character values as defined
in ISO 8859-1:1987. The eight-bit values, within the range from 0 to 127 of ISO 8859-1987
correspond to the ASCII standard character set. Values from 0 to 31 are disallowed with the
exception of 7 (BEL), 9 (Horizontal Tab), 11 (Vertical Tab), and 13 (CR), where 13 is reserved as
a record terminator. Values from 32 to 126 and from 128 to 254 are allowed. Values 127 and 255
are also not allowed.
Allowed characters: 7, 9, 11, 12, 13, 32-126, 128–254
Disallowed characters: 0–6, 8, 10, 14-31, 127, 255
All records are to be terminated with character 13 (CR).
The message structure and the record structure are detailed in the sections that follow.
Uploads
Results
Messages will contain the Header (H) record, Patient (P) record, Order (O) record, Result (R)
record, and the Terminator (T) record. The records will appear in the following manner:
H
P|1
O|1
R|1
R|2
R|n…
O|n
R|n
L
Note: Result messages will contain one patient per message, but they may contain multiple
order and result records per patient record.
Query
Messages will contain the Header record (H), Request for Information (Q) record, and the
Terminator (T) record. The records will appear in the following manner:
H
Q|1
Q|2
Q|n…
L
Downloads
Orders
Messages should contain the Header (H) record, Patient (P) record, Order (O) record, Comment
(C) record (required for XM orders), and the Terminator (T) record. The records should appear in
the following manner:
H
P|1
O|1
C|1
O|2
C|1
O|n…
P|n
L
Note: Multiple orders per patient and multiple patient records per message can be received.
Only one comment record per order record is expected.
Header Record
Field Comp Field/Component Name Req Description on use
1 Record type ID B H
The character H identifies the record as the header record.
2 Delimiter Definition B | - field delimiter
\ - repeat delimiter
^ - component delimiter
& - escape character
Note: The five characters that immediately follow the H (the
header ID) define the delimiters to be used throughout the
subsequent records of the message. A field delimiter follows
these characters to separate them from subsequent fields.
The first six (6) characters of the header record will appear as
follows: H|\^&|
3 Message Control ID
4 Access Password
5 Sender Name or ID B Echo
Instrument will send Echo as the Sender Name/ID.
Instrument will accept the ID that the LIS sends.
6 Sender Street Address
7 Reserved Field
8 Sender Telephone
9 Characteristic of Sender
10 Receiver ID B Echo
Instrument will send the configurable LIS ID.
Instrument will expect Echo when receiving messages.
11 Special Instructions
12 Processing ID
13 ASTM Version No. B LIS2-A2
14 Date and time of message B YYYYMMDDHHMMSS
Patient Record
Field Comp Field/Component Name Req Description on use
1 Record Type ID B P
The character P identifies the record as the patient record.
2 Sequence Number B 1, 2, 3, n…
The number used defines the nth occurrence of the patient
record.
3 Practice Assigned ID O Medical Record Number
4 Laboratory Assigned ID
5 Patient ID No. 3
6 Patient Name O Last Name^First Name^Middle Name
6.1 Last Name O Patient Last Name
6.2 First Name O Patient First Name
6.3 Middle Name or Initial O Patient Middle Name (or Initial)
7 Mothers maiden name
8 Birthdate O YYYYMMDD or YYYYMMDDHHMMSS
9 Patient Sex O M, F, or U
10 Patient Ethnic origin
11 Patient Address
12 Reserved Field
13 Patient Tel Number
14 Attending Physician
15 Special Field 1
16 Special Field 2
17 Patient Height
18 Patient Weight
19 Patient’s Diagnosis
20 Patient Active Medicines
21 Patient’s Diet
22 Practice Field No. 1
23 Practice Field No. 2
24 Admission & Discharge
25 Admission status
26 Location
27 Alt. Diagnosis
28 Alt. Diagnosis Code
29 Patient Religion
30 Marital Status
31 Isolation Status
32 Language
33 Hospital Service
34 Hospital Institution
35 Dosage category
Note: The Echo does not authenticate nor verify the Patient Demographics received in fields 3,
6, 8, and 9. The instrument will simply return the values that were received from the LIS.
Order Record
Field Comp Field/Component Name Req Description on use
1 Record type ID B O
The character O identifies the record as the order record.
2 Sequence Number B 1, 2, 3, n…
The number used defines the nth occurrence of the order
record at a particular hierarchical level and is reset to 1
whenever a patient record of greater hierarchical significance
is transmitted.
3 Specimen ID B Sample Accession Number
4 Instrument Specimen ID
5 Universal Test ID ^^^Assay Code
5.1 Universal Test ID Reserved by standard
5.2 Universal Test ID Name Reserved by standard
5.3 Universal Test ID Type Reserved by standard
5.4 Instrument Code B Instrument Assay Code
See Instrument Assay Code Table
6 Priority B R (See Priority Code Table)
7 Request Order Date
8 Specimen Collection Date
9 Collection End Time
10 Collection Volume
11 Collector ID
12 Action Code D N (See Action Code Table)
13 Danger Code
14 Relevant Clinical Inf.
15 Date specimen received
16 Specimen Descriptor B Type^Source
16.1 Specimen Type B Blood
16.2 Specimen Source B Patient or Product
Note: Patient is used when sample is from a patient; Product
is used when sample is from a donor unit or product.
17 Ordering Physician
18 Physician Tel No.
19 User Field 1
20 User Field 2
21 Laboratory Field 1
22 Laboratory Filed 2
23 Report Date Time
24 Instrument Charge
25 Instrument Section ID
26 Report Type O Y, Z (See Report Type Table)
27 Reserved Field
28 Location or Ward
29 Infection Flag
30 Specimen Service
31 Specimen Institution
ABOD Check
Forward blood type with Rh determination and 3-Cell screen
Screen
ABOD Check2
Forward blood type with Rh determination and 3-Cell screen
Screen
ABOD Full
Forward and reverse blood type with Rh determination and 3-Cell screen
Screen
ABOD Long
Forward and reverse blood type with Rh determination and 3-Cell screen
Screen
Result Record
Field Comp Field/Component Name Req Description on use
1 Record type ID U R
The character R identifies the record as the result record.
2 Sequence Number U 1, 2, 3, n…
The number used defines the nth occurrence of the result
record at a particular hierarchical level and is reset to 1
whenever an order record of a greater hierarchical
significance is transmitted.
3 Universal Test ID U ^^^Analyte Code
3.1 Universal Test ID Reserved by standard
3.2 Universal Test ID Name Reserved by standard
3.3 Universal Test ID Type Reserved by standard
3.4 Instrument Analyte Code U Instrument Analyte Code
See Analyte Code Table
4 Measurement Value U Original Reaction^Edited Reaction^Measured Value
If providing well results, this field is divided into components
as described in 4.1, 4.2, and 4.3. If the Analyte code
indicates an interpretive value, only component 4.1 will be
populated.
See Measurement Value Table for possible values
4.1 Original Result Value U Original instrument reaction
4.2 Edited Result Value U User edited reaction
4.3 Measured Value U Instrument measured reaction
5 Units
6 Reference Range
7 Result Abnormal Flags
8 Nature of Abnormality
9 Result Status U F (See Result Status Code Table)
10 Date of Change in Instrument
11 Operator Identification U Operator ID
12 Date/Time test started
13 Date/Time test completed U YYYYMMDDHHMMSS
14 Instrument Identification U Instrument serial number
Note: The sequence of the Analyte Codes in the Upload Messages is not fixed.
Note: Analyte Codes are subject to change.
Comment Record
Field Comp Field/Component Name Req Description on use
1 Record type ID D C
The character C identifies the record as a comment record.
2 Sequence Number D 1, 2, 3, n…
The number used defines the nth occurrence of the query
record
3 Comment Source D L
4 Comment Text D Donor^Actual Unit Number
4.1 Comment Code D Donor
4.2 Comment Text D Actual donor or unit number identifier
5 Comment Type
Terminator Record
Field Comp Field/Component Name Req Description on use
1 Record type ID B L
The character L identifies the record as the terminator record.
2 Sequence Number B 1
There will only be one terminator record per message.
3 Termination Code B N (See Termination Code Table)
Examples
Result
ABOD Full Screen
H|\^&|||Echo|||||LIS|||LIS2-A2|20060306164429
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^^ABOD Full|R||||||||||Blood^Patient
R|1|^^^Rh Ctrl|0^0^0|||||F||brentp||20060306164429|M0002
R|2|^^^Anti-A|0^0^0|||||F||brentp||20060306164429|M0002
R|3|^^^Anti-B|3+^3+^45|||||F||brentp||20060306164429|M0002
R|4|^^^Anti-AB|3+^3+^45|||||F||brentp||20060306164429|M0002
R|5|^^^Anti-D1|3+^3+^29|||||F||brentp||20060306164429|M0002
R|6|^^^Anti-D2|3+^3+^40|||||F||brentp||20060306164429|M0002
R|7|^^^A1 Cells|2+^2+^17|||||F||brentp||20060306164429|M0002
R|8|^^^B Cells|0^0^0|||||F||brentp||20060306164429|M0002
R|9|^^^ABOD Full Interp|B Pos|||||F||brentp||20060306164429|M0002
O|2|0651439A||^^^Screen|R||||||||||Blood^Patient
R|1|^^^Screen 1|4+^4+^100|||||F||brentp||20060306164429|M0002
R|2|^^^Screen 2|4+^4+^99|||||F||brentp||20060306164429|M0002
R|3|^^^Screen 3|4+^4+^100|||||F||brentp||20060306164429|M0002
R|4|^^^Pos Ctrl|4+^4+^100|||||F||brentp||20060306164429|M0002
R|5|^^^Screen Interp|Pos|||||F||brentp||20060306164429|M0002
L|1|N
Crossmatch
H|\^&|||Echo|||||LIS|||LIS2-A2|20060309084558
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^^Crossmatch|R||||||||||Blood^Patient
R|1|^^^Donor|R02460|||||F||brentp||20060309084558|M0002
R|2|^^^IgG XM|3+^3+^68|||||F||brentp||20060309084558|M0002
R|3|^^^Ind Ctrl|4+^4+^94|||||F||brentp||20060309084558|M0002
R|4|^^^Crossmatch Interp|Incomp.|||||F||brentp||20060309084558|M0002
L|1|N
Donor
H|\^&|||Echo|||||LIS|||LIS2-A2|20060310100612
P|1|||||||
O|1|FY72698||^^^Donor Short|R||||||||||Blood^Product
R|1|^^^Rh Ctrl|0^0^0|||||F||brentp||20060310100612|M0002
R|2|^^^Anti-A|0^0^0|||||F||brentp||20060310100612|M0002
R|3|^^^Anti-B|0^0^0|||||F||brentp||20060310100612|M0002
R|4|^^^Anti-D|3+^3+^24|||||F||brentp||20060310100612|M0002
R|5|^^^Donor Short Interp|O Pos|||||F||brentp||20060310100612|M0002
L|1|N
Query
H|\^&|||Echo|||||LIS|||LIS2-A2|20050222140243
Q|1|0651439A||ALL
Q|2|R02460||ALL
L|1|N
Order
H|\^&|||LIS|||||Echo|||LIS2-A2|20050222140243
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^^Crossmatch|R||||||N||||Blood^Patient
C|1|L|Donor^R02460
L|1|N
H|\^&|||LIS|||||Echo|||LIS2-A2|20050222140243
P|1|1171984|||Patient^Test||19590422|M
O|1|0651439A||^^^ABOD Full Screen|R||||||N||||Blood^Patient
L|1|N
H|\^&|||LIS|||||Echo|||LIS2-A2|20050222140243
P|1|
O|1|FY72698||^^^Donor Short|R||||||N||||Blood^Product
L|1|N
References
NCCLS. Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical
Instruments and Computer Systems. NCCLS document LIS1-A [ISBN 1-56238-489-9]. NCCLS,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2003.
NCCLS. Specification for Transferring Information Between Clinical Laboratory Instruments and
Information Systems; Approved Standard—Second Edition. NCCLS document LIS2-A2 [ISBN 1-
56238-550-X]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2004.