random access clinical chemistry analyzer

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LIS Manual

Ref. 10920
006958-901R0, 2008-03
EasyRA LIS Interface manual

Table of Contents

Introduction................................................................................................................. 1
EasyRA LIS Functions........................................................................................................ 1
Communications Protocol................................................................................................. 1
Operational Overview............................................................................................2
Downloaded Test Requests..............................................................................................2
Uploaded Test Results.....................................................................................................2
Mechanical and Electrical Interfaces................................................................................3
Communications Interface...............................................................................................3
RS-232 Protocols...........................................................................................................3
Datalink Layer................................................................................................................3
Record Processing..........................................................................................................3
EasyRA LIS Application Interface..........................................................................4
Record Types.................................................................................................................4
Record Processing..........................................................................................................4
Header Record...............................................................................................................4
Patient Record................................................................................................................5
Order Record................................................................................................................6
Result Record.................................................................................................................7
Terminator Record..........................................................................................................8
Result Flags Code...........................................................................................................9
Analyte Codes............................................................................................................... 12


Introduction

The EasyRA chemistry analyzer has the capability to communicate with a

laboratory information system, or LIS, based on the CLSI/NCCLS standards
LIS1-A and LIS2-A2. The communication protocol is not a complete imple-
mentation of the standard, but will cover those areas that will allow the
EasyRA to receive and send test requests and orders consistent with the
requirements of the standards. The details of the communication are
described in this document.

EasyRA LIS Functions

The system provides the two central LIS functions of remote access and con-
trol. First, from a laboratory computer, it receives and stores information with
respect to test requests for uniquely identified sample specimens. Second,
through its internal barcode reader, it matches samples to requested tests and
on completion of the tests, sends the results back to the laboratory computer. In
addition, the system provides a means for configuring and indicating the status
of the LIS connection.

Communications Protocol
The ASTM communications protocol was designed specifically for medical
devices and supports the transfer of an array of medical data. Information
about this protocol can be found in publications produced by the Clinical
Laboratory Standards Institute (CLSI) formerly NCCLS.

References:
(NCCLS. Standard Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory, 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.)


 Operational Overview

Downloaded Test Requests

When connected to an LIS system, the EasyRA is always listening for test requests. The
EasyRA will not request test downloads and will not operate in a host query mode.
A maximum number of 400 pending samples and associated tests are stored in the
program’s buffer. Additional test requests over write earlier ones – oldest request first.
The user interface provides a menu to select viewing of the LIS pending list. The fol-
lowing data elements appear with each sample/order request: Patient name, patient
ID, specimen ID (accession number), selected tests, priority, date of birth, gender,
attending physician and time of collection. The EasyRA recognizes only one patient
record at a time. Within an order record, the EasyRA supports its own test identifica-
tion scheme (Analyte Codes) detailed later in this document. If a test is ordered which
is not supported, the EasyRA will ignore it.

The EasyRA recognizes barcode labeled sample tubes using one of the following for-
mats: Codabar, Code39, 128, and Interleaved 2 of 5. Barcodes must be no longer
than 5.72 cm and have a line width of no less than 0.5mm.

When the EasyRA is in the LIS mode of operation, a worklist inventory includes an
attempt to read a barcode at every sample position. At the end of the inventory, the
program matches pending LIS requests with barcodes read. If any selected tests are
not available to run, the EasyRA informs the user in the same manner as when it is
operating in the non-LIS mode. If a barcode is read that cannot be matched to a pend-
ing order request, a warning of this condition is also signaled in the user interface.

Uploaded Test Results

The EasyRA does not batch test results with samples. As a test result becomes avail-
able, a result record is composed, attached to its patient and order record, and
echoed back to the LIS. Requested tests not performed are purged from the LIS pend-
ing list after 60 days.

Data elements in a result message include: specimen ID, sequence number, selected
test, result value, units, normal ranges, abnormality flags, operator ID, result status,
and time of result. A detailed description of the abnormality flags (Result Flags Code)
is included later in this document.

Comment records are not supported.


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The Header record in a result message will contain sufficient information to

determine which EasyRA instrument is sending results information should there
be more than one EasyRA connected to the LIS.

Mechanical and Electrical Interfaces

A standard RS-232 interface cable with a DB9M termination is used to con-
nect the EasyRA’s computer interface to the laboratory computer. If the labora-
tory computer connection is not standard RS-232 an interface adapter must
be used. The EasyRA interface uses standard voltage levels and electrical
characteristics as defined in the EIA Standard RS-232.

Communications Interface
RS-232 Protocols
The default RS-232 protocols for the EasyRA are 19200 baud, 8 data bits, no
parity, and 1 stop bit. The system can be configured to support 9600, 38400,
57600, and 115200 baud.

Datalink Layer
The datalink layer supports the CLSI/NCCLS protocol documented for
standard LIS1-A Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory Instruments and Computer Systems. These
requirements include the means of establishing communication, error detec-
tion, error recovery, and the formatting for sending and receiving messages.

Record Processing
The record processing layer specifies the content of the records in accordance
with CLSI/NCCLS protocol Specification for Transferring Information Between
Clinical Laboratory Instruments and Information Systems. These requirements
define the hierarchical message structure, record and field composition, and
delimiters.


 EasyRA LIS Application Interface

Record Types

The instrument supports the following record types: Header Record, Patient Record, Order
Record, Result Record, and Trailer Record. The instrument ignores all other record types.

Record Processing

The tables below describe the contents to the supported fields within the records recognized by
the EasyRA system. Unsupported fields are ignored on download and a null is assigned to these
fields on an upload. Record Type fields also contain an alphabetic character to define the type
of record being processed. For example the Header Record Type would contain an "H".

Header Record
Field Field Type Download Upload Max Description
Requirement Requirement Len

1 Record Type R A 1 Required Field containing H

2 Delimiters R A 4 Default values:

Field Delimiter |
Repeat Delimiter \
Component Delimiter ^
Escape Delimiter &

5 Sender ID I A 8 Name of device sending data

13 Version# R A 8 ASTM Protocol Version

(E1394-97)

14 Date and Time I A 14 Date and time of

transmission
Formatted as
YYYYMMDDHHMMSS.
Download and Upload Requirements Field Legend:
R Required
I Ignored
A Always


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Patient Record
Field Field Type Download Upload Max Description
Requirement Requirement Len

1 Record Type R A 1 Required Field containing P

2 Sequence R A 1 Starts with 1 for the first patient

Number and is incremented by one for each
patient in the transmission

3 Lab Assigned R A 14 Assigned by the LIS. Stored in the

Patient ID Patient ID field for upload

6 Patient Name O S 20^20^1 Three components:

Last Name
First Name
Middle Initial

8 Birth Date O S 8 Formatted as YYYYMMDD.

9 Gender O S 1 Default values:

M – male
F – female
U – unassigned

14 Attending O S 20^20^1 Three components:

Physician Last Name
First Name
Middle Initial

Download and Upload Requirements Field Legend:

R Required
O Optional
A Always
S Sometime


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Order Record
Field Field Type Download Upload Max Description
Requirement Requirement Len

1 Record Type R A 1 Required Field containing O

2 Sequence R A 1 Starts with 1 for the first order

Number record and is incremented by
one for each additional order
record for a patient

3 Specimen ID R A 14 The analyzer uses and reports its

results based on the value in this
field

5 Universal R A Varies Contains four components.

Test ID The first three are ignored.
The fourth component is the
Manufacturer's Code (see
Analytes Code Table)

6 Priority O S 1 Indicates processing priority:

S – STAT
R – Routine

8 Collection O S 14 Date and time of sample

Time collection. Formatted as
YYYYMMDDHHMMSS.

16 Sample Type O S 5 Indicates sample material:

“Serum” or “Urine”

Download and Upload Requirements Field Legend:

R Required
O Optional
A Always
S Sometime


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Result Record
Field Field Type Download Upload Max Description
Requirement Requirement Len

1 Record Type - A 1 Required Field containing R

2 Sequence - A 4 Starts with 1 for the first result and

Number is incremented by one for each
additional result within the order.
Resets to 1 when the results of
another order are transmitted.

3 Universal Test ID - A 6 Contains four components. The first

three are ignored. The fourth com-
ponent is the Manufacturer's Code
(see Analytes Code Table)

4 Test Result - A 8 Floating point number if the num-

ber of decimal places is configured
in the instrument to be greater than
0. An unreportable result is repre-
sented by “-E-“ or “---“

5 Units of Measure - A 8 Configured by the operator for

individual analytes

7 Abnormality Flags - S 2 Two character code to represent

abnormal results (see Result Flag
Code table). This field may be
repeated once.

9 Result Status - A 1 Required field contains F

11 Operator ID - S 8 ID of operator running the test

13 Time Test - A 14 Date and time of test completion.

Completed Formatted as
YYYYMMDDHHMMSS.

Download and Upload Requirements Field Legend:

A Always
S Sometime


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Terminator Record
Field Field Type Download Upload Max Description
Requirement Requirement Len

1 Record R A 1 Required Field containing L

Type

2 Sequence R A 1 Contains the value 1

Number
3 Termination R A 1 Contains the value N
Code

Download and Upload Requirements Field Legend:

R Required
A Always


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Result Flags Code

The following table defines the abnormality flags that may be embedded in a result record.
A maximum of two flags may be included within any result record.

Flag Description Condition Action

AA (ISE) Air in Cal A Air bubble was detected in Test results are not shown –
A Calibration Fluid Repeat test; Prime ISE
Calibration Fluid – Repeat
test; Replace ISE Reagent Pack
– Repeat test

AB (ISE) Air in Cal B Air bubble was detected in Test results are not shown–
B Calibration Fluid Repeat test; Prime ISE
Calibration Fluid –Repeat test;
Replace ISE Reagent Pack
– Repeat test

AD (ISE) Cal A mV Drift Two subsequent Cal A mV Test results are not shown –
measurements differ by more Repeat test; Prime ISE
than a specified amount Calibration Fluid – Repeat
test; Replace ISE Reagent Pack
– Repeat test

AN (ISE) Cal A mV Noise Individual mV readings differ Test results are not shown –
by more than 0.7 mV from Repeat test; Prime ISE
a mean value Calibration Fluid – Repeat
test; Troubleshoot ISE Module
– Repeat test

AS (ISE) Air in Sample Air bubble was detected in Test results are not shown –
Sample Fluid Repeat test; Troubleshoot
– Repeat test

BA Blank Absorbance Reagent Blank absorbance Calibration results are shown

exceed an absorbance limit but sample testing is not
allowed – Repeat Calibration;
Troubleshoot – Repeat
Calibration

BN (ISE) Cal B mV Drift Two subsequent Cal B mV Test results are shown – Repeat
measurements differ by more test; Prime ISE Calibration Fluid
than a specified amount – Repeat test; Replace ISE
Reagent Pack – Repeat test


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CD Calibration Deviation One or more calibration results Calibration results are shown
differ by more than a preset but value sample testing is not
percentage from the Mean allowed – Repeat Calibration;
calibration value Troubleshoot – Repeat Calibration

CF Calibration Factor Range Calibration Factor result is Calibration results are shown but
outside the allowable range sample testing is not allowed–
Repeat Calibration; Troubleshoot
– Repeat Calibration

CR Outside Critical Range Sample results are outside Sample results are highlighted
the user defined critical range in red – Repeat test

DS Slope Drift Back to back calibrations for a Calibration results are shown but
particular ISE sensor exceeded sample testing is not allowed
a preset value – Repeat Calibration; Troubleshoot
– Repeat Calibration

EN End Point Noise Two end point absorbance Sample results are shown – Repeat
measurements differ by more test; Troubleshoot – Repeat test
than 1% or 0.002 Abs. units,
whichever is larger

HA High Absorbance Measured absorbance is greater Sample results are shown –

than 2.5 Abs. units repeat test

HN High Reaction Rate For kinectic reactions, where Sample results are not shown
Noise two or more points are 0.003. – repeat test
Abs. units away from the line
of best fit

LH Linear Range High Results are above the linear Sample results are not shown – test
range of the reagent for a should be repeated and instrument
particular test; the range is shown will automatically retest with
on the reagent insert sheet a larger dilution ratio

LL Linear Range Low Results are below the linear Samples results are not shown
range of the reagent for a – repeat test
particular test; the range is
shown on the reagent insert sheet

LH (ISE) Linear Range High Results are above the test range Samples results are not shown
of the reagent for a particular –test should be repeated and
ISE test; the range is shown on instrument will automatically
the reagent insert sheet retest with a larger dilution ratio.

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LL (ISE) Linear Range Low Results are below the test range. Samples results are not shown
limits for a particular sensor –Repeat test.
The ranges are programmed into
the ISE Module software

MV (ISE) Cal A / Cal B Cal A or Cal B mV are out of the Sample results are shown
Out of mV range specified range – Repeat test; Troubleshoot
– Repeat test

NF (ISE) No Flow ISE module could not position Test results are not shown
sample or calibration material Repeat test; Troubleshoot
– Repeat test

NR Outside Normal Limits Test result for a particular chemistry Sample results are shown in
is outside the user defined gold/yellow – Repeat sample
normal range results

QC QC Confidence Range QC results are outside the interval QC results are shown
for a test pre-set by the user – Repeat QC test;
Troubleshoot – Repeat QC test

RD Reaction Direction Chemical reaction is going in Results are shown – Repeat

the incorrect direction test; Troubleshoot – Repeat test

RN Reaction Rate Noise For kinetic reactions, where one Results are shown – Repeat
point is 0.003 Abs. units away test; Troubleshoot – Repeat
from the line of best fit test

RR Outside Rerun Range Test result for a particular chemistry Sample results are shown
is outside the user defined and re-run box is automati-
re-run range cally checked – Repeat test

SD Substrate Depletion Substrate for enzyme activity Sample results are not shown
measurement is used up and re-run box is automati-
(exceeds linear range of method cally checked – test should be
– results if displayed would repeated and instrument will
be misleading) automatically retest with a
larger dilution ratio

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Analyte Codes

Code Analyte

ALB Albumin
ALP Alkaline Phosphatase
ALT Alanine Aminotransferase
AMY Amylase
AST Aspartate Aminotransferase
BUN Urea Nitrogen
Ca Calcium
CHOL Cholesterol
CK Creatine Kinase
Cl- Chloride
CO2 Total Carbon Dioxide
CREA Creatinine
DBIL Direct Bilirubin
HDL HDL Cholesterol
Fe Iron
GGT Gamma Glutalmyltransferase
GLU-H Glucose Hexokinase
GLU-T Glucose Trinder
K+ Potassium
LDH Lactate Dehydrogenase
Li+ Lithium
Mg Magnesium
Na+ Sodium
PHOS Phosphorus
TBIL Total Bilirubin
TP Total Protein
TRIG Triglycerides
URIC Uric Acid
UCREA Urine Creatinine

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 006958-901 R0

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