IQ 200 Host Transmission Manual Rev JA

Host Transmission Manual

®

iQ 200 Automated Urinalysis Series ® iRICELL Automated Automated Urinalysis Workcells ® ™ iChem Velocity ™ iWARE Software

300-4941 Revision JA

®

iQ 200 Automated Urinalysis Series iRICELL® Automated Urinalysis Workcells iChem®Velocity™ iWARE™ Software

Host Transmission Manual 300-4941 Rev JA (March 2015) ® iQ®200 Automated Urinalysis Series and a nd iRICELL Automated Urinalysis workcells includes udes the following instruments as individual or workcell (connected) (connected) systems: •

iQ®200 Microscopy analyzer

•

iChem®Velocity

™

analyzer

nd us on the World Wide Web at: Find us www.beckmancoulter.com

Revision History REVISIONS

WRITTEN/REVISED BY

A

Greg Loa

B

Greg Loa

C

Greg Loa

D

Greg Loa

E

Carol Eden

F

Greg Loa

COMMENTS

Updated Header and Footer Updated transmission samples and screenshots. Added DRBC in the Appendix.

G

Greg Loa

Updated example 8 and added ASP, Count Controls and Body Fluid Control in the Appendix

H

Greg Loa

Added table of content, updated the definitions, added LIS changes between Software versions, updated examples and added letter to customers and distributor partners

I

Greg Loa

Replaced 7.0.1 with 7.0.2 No other changes changes from 7.0.1 to 7.0.2 7.0.2 are necessary

J

Greg Loa

Replaced 7.0.2 with 7.0.5, added changes from 7.0.2 to 7.0.5, added ASA in the Appendix

JA

Greg Loa

Extensively rewritten based on revision J

This document applies to the latest software listed and higher versions. When When a subsequent subsequent software version affects the released to the Beckman Coulter website. For labeling updates, go to information in this document, a new issue will be released www.beckmancoulter.com and download the latest version of the manual or system help for your instrument.

Safety Notice Read all product manuals and consult with Beckman Coulter-trained Coulter-trained personnel before attempting to operate instrument. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your Beckman Coulter representative.

Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited limited to, protective protective eyewear, eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other autom ated laboratory analyzer.

Alerts for Warning and Caution WARNING WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. May be used to indicate the possibility of erroneou s data that could result in an incorrect diagnosis (does not apply to all products).

CAUTION CAUTION indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. May be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis (does not apply to all products).

Safety Notice WARNING Risk of operator injury if: •

• • • • •

•

All doors, covers and panels are not closed and secured in place prior to and during instrument operation. The integrity of safety interlocks and sensors is compromised. Instrument alarms and error messages are not acknowledged and acted upon. parts. You contact moving pa You mishandle broken parts. Doors, covers and panels are are not opened, closed, removed and/or replaced with care. Improper tools are used for troubleshooting.

To avoid injury: •

• • • • • •

eep doors, K eep

covers and panels closed and secured in place while the instrument is in use. Take full advantage of the safety features of the instrument. Acknowledge and act upon instrument alarms and error messages. eep away from moving parts. K eep Report any broken parts to your Beckman Coulter Representative. Open/remove and close/replace doors, covers and panels with care. Use the proper tools when troubleshooting.

CAUTION System integrity could be compromised and operational failures could occur if: •

•

•

This equipment is used in a manner other than specified. Operate the instrument as instructed in the product manuals. You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s software with software authorized by Beckman Coulter. software that is not an original copyrighted version. Only use You install software software that is an original copyrighted version to prevent virus contamination.

CAUTION If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.

Contents

Revision History Safety Notice

Introduction CHAPTER 1:

ASTM: Low-Level Protocol ASTM Physical Layer Serial Data Exchange Data Link Layer Establishment Phase Transfer Phase Frame Number Checksum Acknowledgements Receiver Interrupts Termination Phase Defective Frames Timeouts During Establishment Phase During the Transfer Phase Receiver Waiting for Frame Sender Wait on Reply Restricted Characters Transport layer Sequence

CHAPTER 2:

Iris defined XML: High-Level Protocol Message Content Communication Verification Message Specimen Analysis Report Message Specimen Information Query Message Specimen Information Response Message Specimen Information Response Message for Unrecognized Specimen Identifier Chemistry Control Report Message Count Control Report Message Body Fluid Control Report Message

APPENDIX A:

Additional Tables Test Identifiers/Upload codes LOINC Codes

APPENDIX B:

Iris defined XML: Sample Messages Verification Example Specimen Information Query Example

Specimen Information Response Example

Specimen Information Response for Unrecognized Specimen Identifier Specimen Analysis Report Example Chemistry Control Report Example Count Control Report Example Body Fluid Control Report Example

APPENDIX C:

Glossary

Introduction

Purpose The La boratory boratory Information Information System (LIS) feature of the iQ ®200 Automated Urinalysis System, iRICELL®Series, iChem®Velocity™, iWARE™ Software allows an external laboratory computer to communicate with the System Manager through a serial connection. connection. The iQ®200 Automated Urinalysis System, iRICELL ®Series, iChem®Velocity™, iWARE™ Software make an interface standard available: •

American Society for Testing and Materials (ASTM)

The ASTM AST M 1381-95 interface standard is used as low-level protocol and Iris defined XML is used as high-level pro proto toco coll: •

ASTM 1381-95

two par par ts: — Low-Level Protocol which consists of two · Physical Layer (see ASTM Physical Layer in CHAPTER 1, ASTM 1381-95: Low-Level Protocol). · •

Data Link Layer (see Data Link Layer in CHAPTER 1, ASTM 1381-95: Low-Level Protocol) .

Iris defined XML

— Message Content (see Message Content in CHAPTER 2, IRIS-defined XML Protocol: Message Layer ) which contains the specifications for each of the records that t hat are used to pass information between the instrument and the laboratory computer.

Standards/Protocols 



The iRICELL® Series with System Manager Software facilitates the connection of the ® ® ™ iQ 200 microscopy analyzer and the iChem Velocity a workcell configuration. The iQ®200 Automated Urinalysis System, iRICELL ®Series and iChem ®Velocity™ can be interfaced over Serial connection only.



®

®

®

™

The iQ 200 Automated Urinalysis System, iRICELL Series and iChem Velocity do not have the capability for TCP/IP and remote access.

CHAPTER 1

ASTM: Low-Level Low- Level Protocol

To accomplish a successful interface between the System Manager and the laboratory computer, a compatible environment, environment, both physical and logical, must be established. At the lowest level, the physical connections connections must be defined and the behavior of both the sender and receiver of information must be specified.

Instrument and the laboratory laboratory The Low-Level Protocol to use for transferring messages between the Instrument computer is the ASTM 1381-95).

ASTM Physical Layer

Serial Data Exchange All serial communications are expected to use the EIA-232-D communication protocol, communication protocol, based upon the Electronics Industries Association (EIA) standard EIA-232-D. The instrument is configured as Data Terminal Equipment (DTE). Pr ot otocol: EIA-2 32 -D Connecto Connector : DB-9 Male located on the back of the Instrument Console PC COM Port: LIS Table 1.1 Physical Parameters

Physical Setting

Default Value

Possible Values

ate s Baud R ate

9600

300, 1200, 2400, 4800, 9600, 19200, 38400

Data Bits

8

7, 8

ts Parity Bits

None

Even, Odd, None, Mark, Space

Stop Bits

1

1, 2

Table 1.2 DB-9 Pin Assignments for EIA-232-D Connection

Pin

Instrumen nstrument

LIS Port Configuration Provided on DB-9 Male

Laboratory Computer Cable Must Provide on DB-9 Female

2

R XD

TX D

3

T XD

R XD

5

Ground

Ground

NOTE Co nnection from computer to computer usual ly requires a Null Modem Cable as indicated in the table. above tabl Figure 1.1 Host Cable Connector Diagram 5

4

9

3

8

1

2

7

Ground on pin 5

6 TXD on pin 2

RXD on pin 3

Data Link Layer The data link layer has procedures for f or link connection and release, release , delimiting and synchronism, sequential control, error detection, and error recovery as specified in ASTM distinct phases in transferring information between the System 1381-95. There are three distinct phases Manager and the laboratory computer. computer. The three phases assure the actions of sender and receiver are coordinated. The three phases are establishment, transfer, and ter mination. The data link layer uses a character-oriented protocol character-oriented protocol to send messages between directly connected systems. The data link mode of operation is one-way transfer of information information with alter nate nate supervision. Information flows in one direction at a time. Replies occur after information is i s sent, never at the same time. It is a simple stop-and-wait protocol. At times the two systems are actively operating to transfer information. The remainder of the time the data link lin k is in a neutral state.

Establishment Phase The establishment phase determines the direction of information flow and prepares the receiver to accept information. A system, which does not have information to send, normally monitors the data link to detect the establishment phase. It acts as a receiver, waiting for the other system.

The system with information available initiates the establishment phase. After the sender determines the data link is in a neutral state, it transmits the transmission control character . The receiver ignores any character other than while in the neutral state. Sender will ignore any responses to the other than , , or R eceiver

State

Sender

Receiver Ready Ready

eceiver R eceiver

Tr ansf ansf er er Phase

Wait 10 seconds, then send agaiin. aga

*2

-->

<-Receiver sending *1

Sender Status After Receiving R esponse

-->

<--

Not Ready Receiver Not

Reply

-->

<--

*1 Line Contention condition - Receiver also has information available and sent the ENQ at the same time as the sende r . *2 If Sender is the Instrument, wait 1 second and then begin then begin establishment phase by sending . If Sender is the laboratory computer, the laboratory computer goes into a neutral state for a minimum of 20 seconds or until the receive message session from the System Manager is complete.

Transfer Phase During the transfer phase, the sender transmits messages to the receiver. The transfer phase continues until all messages are sent. Messages are sent in frames. Each frame contains a maximum of 247 characters (including frame overhead). Messages longer than 247 characters ar e divided between two or more frames. Multiple messages are never combined in a single frame. Every message must begin must begin in a new frame. There are two types of fr ame ames: intermediate and end. The intermediate frames terminate with the character , checksum, . End frames terminate with , checksum, . A message containing 247 characters or less is sent in a single end frame. Longer messages are sent in intermediate frames with the last part of the message sent in the end frame.

Frame Number The frame number permits the receiver to distinguish between new and retransmitted retransmitted frames. It is a single digit sent immediately after the character. The frame number is i s an ASCII digit ranging from 0 to 7. The frame number begins at 1 with the first frame of the Transfer phase. The frame number is incremented by one for every new frame transmitted. After 7, the number rolls over to 0, and continues in this fashion.

Checksum checksum permits the receiver The checksum permits receiver to detect a defective frame. The checksum is encoded as two characters, which are are sent after the , or character. The checksum is computed by adding the binary values of the characters, keeping the least significant eight bits of the result. The checksum is initialized to zero with the character. The first character character used in computing the checksum is the frame number. Each character in the message text is added to the checksum (modulo 256). The computation for the checksum does not include , the checksum characters, characters, or the trailing . The checksum is an integer represented by eight bits; it can be considered as two groups of four bits. The groups of four bits are are converted converted to the ASCII characters characters of the hexadecimal representation. The two ASCII characters are transmitted as the checksum, with the most significant character first.

Acknowledgements After a frame is sent, the sender stops transmitting received. The receiver transmitting until a reply is received. replies to each frame. When it is ready to receive the next frame, it transmits one of three replies to acknowledge the last frame. This reply must be transmitted transmitted within the timeout period. (See Timeouts for additional information.) A reply of signifies the last frame was received successfully and the receiver is prepared to receive another frame. The sender must increment the frame number and either send a new frame or terminate. A reply of signifies the last frame was not successfully received and the receiver is prepared to receive the frame again. A reply of signifies that the last frame frame was successfully received; the receiver r eceiver is prepared to receive another frame, but is a request request to the sender to stop tr ansmitting.

Receiver Interrupts The receiver interrupt interrupt is a means for the receiver to request the sender to stop tr ansmit ansmitting messages as soon as possible. During During the transfer phase, if the receiver recei ver responds to a frame with an in place of the usual , the sender must interpret this reply as a receiver acknowledgem ent of the end frame, interrupt request. The is a positive a positive acknowledgement f rame, signifies the receiver is prepared to receive next frame, and is a request to the sender to stop transmitting. The sender does not have to stop transmitting after receiving the receiver interrupt interrupt request. re-request the interrupt for the If the sender chooses to ignore the , the receiver must re-request request to remain valid. If the sender chooses to honor the receiver interrupt request, it must must first enter the termination terminat ion phase phase to return the data link to the neutral state. This gives the receiver an opportunity opportunity to enter the establishment phase and become the sender. The original sender sender must not enter the establishment phase for at least 15 seconds or until the receiver has sent a message and returned the data link to to the neutral state.

Termination Phase The termination termination phase returns the data link to the clear or neutral state. The sender sender notifies the receiver that all messages have been sent. The sender transmits the transmission control character and then regards the data link to be to be in a neutral state. Upon receiving , the r eceiver also regards the data link to be in a neutral state .

Defective Frames transmitted for invalid A receiver checks every frame to guarantee it is valid. A reply of is transmitted frames. Upon receiving the , the sender retransmits retr ansmits the last frame with the same frame ceiver number. In this way, transmission errors are detected and automatically corrected. The re receiver ignores any characters occurring occur ring before the or or after the end of the block character or when checking the frame. A frame should be rejected because: 1. Any character errors are detected (parity error, framing error, etc.) 2. The frame checksum does not match the checksum computed on the received frame 3. The frame number is not the same as the last accepted frame or one number higher (modulo 8).

Upon receiving a or any character except an or (a condition), the sender increments a retransmit counter and retransmits the frame. If this counter shows a single frame was sent and not accepted six times, the sender must abort this message by proceeding to the termination phase. An abort should be extremely extremely rare, but it provides a mechanism mechanism to escape from a condition where the transfer phase cannot continue.

Timeouts The sender and receiver both use timers to detect loss of coordination between them. If a reply of an , or is not received within within 15 seconds, a timeout occurs. After a timeout, the sender enters the termination phase.

During Establishment Phase During the establishment phase, if the computer (as receiver) detects contention, it sets a timer. If an is not received within 20 seconds, a timeout occurs. After a timeout, the receiver regard s the line to be in the neutral state.

During the Transfer Phase During the transfer phase, the sender sets a timer when transmitting the last character character of a frame. If a reply is not received within 15 seconds, a timeout occurs. After a timeout, the sender aborts the message transfer by proceeding to the termination termination phase. As with excessive retransmissions retransmissions of defective frames, the message must be remembered so it can be completely re peated.

Receiver Waiting for Frame During the transfer phase, the receiver sets a timer when first entering the transfer phase or when replying to a frame. If a frame or is not received within 30 seconds, a timeout occurs. After a timeout, the receiver discards the last incomplete message and regards the line to be in the neu tral state.

Sender Wait on Reply A receiver must reply to a frame within 15 seconds or the sender will timeout. A receiver can delay its reply for up to 15 seconds to process the frame. Longer delays cause the sender to abort the message. Receivers that cannot process messages fast enough to keep up with a sender may cause message buffer overflows in the sender. A sender can normally store at least one complete message. Storage space for more than one outgoing message is desirable but optional.

Restricted Characters The data link protocol is designed for sending character-based message text. Restrictions are placed on which characters may appear in the message text. The restrictions make it simpler for senders and receivers to recognize replies and frame fr ame delimiters. Additional characters are restricted r estricted to avoid interfering with software controls for devices such as multiplexers.

An character is not permitted to appear in the message text; it can appear only as the last character of a frame. None of the ten transmission control control characters, the format effector control character, character, or four device control characters may appear in message text. The restricted characters are: , , , , , , , , , , , , , , and .

Transport layer Sequence The following tables illustrate a transport layer sequence: Normal Session

Sender

Establishment Phase

R eceiver

---> <---

Tr ansfer Phase Phase

Ter min ation Phase

[frame

number] [DATA] [C1] [C2] [C2] ---> ---> frames continue until entire message sent sent

<---

--> No R esponse

Expected

Delay Request Session (NAK):

Sender

Establishment Phase

R eceiver

---> <---

< NAK>

(Delay 10 seconds)

---> <---

Tr ans ans f er er Phase

Ter mination Phase

[C2] ---> [frame number] [DATA] [C1] [C2] frames continue until entire message sent sent

<---

--->

No R esponse Expected

Establishment Phase

Ter mination Phase

--->

(Delay 10 seconds)

<---

--->

(Delay 10 seconds)

<---

--->

(Delay 10 seconds)

<---

--->

(Delay 10 seconds)

<---

--->

(Delay 10 seconds)

<---

--->

(Delay 10 seconds)

<---

--->

< NAK>

< NAK>

< NAK>

< NAK>

< NAK>

< NAK>


Establishment Phase

--->

(Time-out af ter ter 15 15 seconds)

Ter mination Phase

No R es ponse --->

No R es ponse Expected

R etransmission Request (Multiple

Establishment Phase

s):

Sender Sender

Receiver

---> <---


[C2] ---> [frame number] [DATA] [C1] [C2] <---

[frame number] [DATA] [C1] [C2] ---> <---




[frame number] [DATA] [C1] [C2] --->

Ter mination Phase

nue unt until frames cont contiinue entire message sent

<---

--->


Failure Session (Max s):

Sender

Establishment Phase

Receiver

---> <---







[C2] ---> [frame number] [DATA] [C1] [C2]

Ter mination Phase

<---

--->


Failure Session (Receiver Timeout During Transfer):

Sender

Establishment Phase

Receiver

---> <---


[C2] ---> [frame number] [DATA] [C1] [C2] <--- No R es ponse within 15 seconds

Ter mination Phase

--->


Failure Session (Sender Timeout During Transfer Phase):

Sender

Establishment Phase

Receiver

---> <---


Ter min ation Phase

[frame number] [DATA] [C1] [C2] ---> --->

No Fr am ame sent within 30 seconds

<---

--->

No R esponse Discards incomplete message and assumes neutral state.

CHAPTER 2

Iris defined XML: High-Level Protocol

XML message layer. The intent of this section This section conforms with Iris defined XML message is to develop a complete understanding of the particular records and fields as supported by the Instrument.

Message Content 1. Communications Communications Verification Message The instrument verifies communications with the host by sending the Communications Verification message, to which the host replies with the same message. attribute form default:

unqualified

element form default:

qualified

Elements IRISPing

element IRISPing

annotation

documentation Used for verification of the c ommunications connection between the IRIS instrument and the LIS. The inst rument sends the IRISPing element, upon receipt of which the LIS sends one back. The LIS never instigates the exchange.

2. Specimen Analysis Report Message The instrument reports patient specimen results with the Specimen Analysis Report message. attribute form default: element form default:

Elements SA

unqualified qualified

element SA diagram

properties children annotation

content

complex

PF AC FL tags reportTags tags reportTags validationTags CM ARV SEL_IMGS ARV SEL_IMGS AUD SysCfg AUD SysCfg SL

documentation SpecimenAnalysis root element.

attribute SA/@BF type properties facets

annotation

restriction of xs:string isRef 0 use required Kind Value enumeration URN enumeration

CSF

enumeration

PLE

enumeration

PER

enumeration

PED

enumeration

PEL

enumeration

PCA

enumeration

SER

enumeration

SYN

annotation documentation urine documentation cerebrospinal fluid documentation pleural fluid documentation peritoneal fluid documentation peritoneal dialysate documentation peritoneal lavage documentation pericardial fluid documentation serous fluid documentation synovial fluid

documentation Specimen type (Body Fluid type)

attribute SA/@ID type properties annotation

xs:string

isRef 0 use required documentation The specimen identifier

attribute SA/@SID type properties annotation

xs:string

isRef 0 use required documentation The system ID

attribute SA/@OP type properties annotation

xs:string

isRef 0 use required documentation Operator

attribute SA/@ADT type properties annotation

xs:string

isRef 0 use required documentation Analysis DateTime with ti me zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute SA/@ADTS type properties annotation

xs:string

isRef 0 use required documentation Analysis DateTime String

attribute SA/@RDT type properties annotation

xs:string

isRef 0 use required documentation Report DateTime with tim e zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute SA/@RDTS type properties annotation

xs:string

isRef 0 use required documentation Report DateTime String

attribute SA/@RP type properties annotation

xs:integer

isRef 0 use required documentation Rack position (tube number in the rack)

attribute SA/@SQN type properties annotation

xs:integer

isRef 0 use required documentation Sequence Number

attribute SA/@RSQN type properties annotation

xs:integer

isRef 0 use required documentation Rack Sequence Number (rack ID)

attribute SA/@DILN type properties annotation

xs:integer

isRef 0 use required documentation Dilution numerator

attribute SA/@DILD type

xs:integer

properties annotation

isRef 0 use required documentation Dilution denominator

attribute SA/@IMP type properties facets

restriction of xs:integer isRef 0 use required Kind Value minInclusive 0 maxInclusive

annotation

annotation

1

documentation Imported 1=yes, 0=no

attribute SA/@CDT type properties annotation

xs:string

isRef 0 use required documentation Chemistry DateTime with ti me zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute SA/@CDTS type properties annotation

xs:string

isRef 0 use required documentation Chemistry DateTime String

attribute SA/@REDT type properties annotation

xs:string

isRef 0 use required documentation Microscopy DateTime with time zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute SA/@REDTS type properties annotation

xs:string

isRef 0 use required documentation Microscopy DateTime String

element SA/PF diagram

type properties

xs:string

isRef

0

annotation

minOcc 0 maxOcc unbounded content simple documentation PreFace (lab information)

element SA/AC diagram

properties

children annotation

isRef minOcc maxOcc content

0 1 2 complex

AR

documentation Analysis Category

attribute SA/AC/@AT type properties facets

restriction of xs:string isRef 0 use required Kind Value enumeration Chemistry enumeration

annotation

annotation

Sediment

documentation Analysis Type

attribute SA/AC/@AS type properties facets

restriction of xs:string isRef 0 use required Kind Value enumeration Done enumeration

annotation

documentation Analysis State

Not Done

annotation

attribute SA/AC/@SO type properties annotation

restriction of xs:string isRef 0 use required documentation Analysis category SOurce

attribute SA/AC/@DSLOT properties annotation

isRef

0

documentation Chemistry dipstick lot

element SA/AC/AR diagram

type properties

annotation

extension of xs:string isRef 0 minOcc 1 maxOcc unbounded content complex documentation Analyte Result

attribute SA/AC/AR/@Key type properties annotation

xs:string

isRef 0 use required documentation Mnemonic uniquely identifying the analyte

attribute SA/AC/AR/@SN type properties annotation

xs:string

isRef 0 use required documentation Short Name

attribute SA/AC/AR/@LN type properties annotation

xs:string

isRef 0 use required documentation Long Name

attribute SA/AC/AR/@AF type properties facets

restriction of xs:integer isRef 0 use required Kind Value minInclusive 0 maxInclusive

annotation

annotation

1

documentation Abnormal Flag

attribute SA/AC/AR/@NR type properties annotation

xs:string

isRef 0 use required documentation Normal Range

element SA/FL diagram

type properties

annotation

xs:string

isRef 0 minOcc 0 maxOcc 1 content simple documentation FLags

element SA/tags diagram

properties

children annotation


0 0 1 complex

tag

documentation LIS Tags as generated by iWARE

element SA/tags/tag diagram

properties


0 1 unbounded complex

attribute SA/tags/tag/@name properties annotation

isRef 0 use required documentation name of the rule

attribute SA/tags/tag/@result properties annotation

isRef 0 use required documentation rule output text

attribute SA/tags/tag/@ruleModified type properties facets

restriction of xs:string isRef 0 use required Kind Value enumeration Yes enumeration

annotation

annotation

No

documentation Has the rule been modified since the specimen was tagged (Yes/No)?

element SA/reportTags diagram

properties

children annotation


0 0 1 complex

reportTag

documentation Report Tags as generated by i WARE

element SA/reportTags/reportTag diagram

properties



attribute SA/reportTags/reportTag/@RuleName properties annotation


attribute SA/reportTags/reportTag/@RuleTaggingResult properties annotation

isRef 0 use required documentation rule output text

attribute SA/reportTags/reportTag/@RuleModified properties annotation

isRef 0 use required documentation Has the rule been modified since the specimen was tagged (Yes/No)?

element SA/validationTags diagram

properties

children annotation


0 0 1 complex

validationTag

documentation Validation Tags as generated by iWARE

element SA/validationTags/validationTag diagram

properties



attribute SA/validationTags/validationTag/@RuleName properties annotation


attribute SA/validationTags/validationTag/@RuleModified properties annotation

isRef 0 use required documentation Has the rule been modified since the specimen was tagged (Yes/No)?

element SA/CM diagram

type properties

annotation

xs:string

isRef 0 minOcc 0 maxOcc 1 content simple documentation Operator comment

element SA/ARV diagram

type properties annotation

xs:string

isRef 0 content simple documentation APR ReVision

element SA/SEL_IMGS diagram

properties

children annotation


0 0 1 complex

SI

documentation Selected images

element SA/SEL_IMGS/SI diagram

properties

annotation

isRef 0 minOcc 1 maxOcc unbounded content complex documentation Selected Image

attribute SA/SEL_IMGS/SI/@img properties annotation

isRef 0 use required documentation Location of image on the instrument

attribute SA/SEL_IMGS/SI/@call properties annotation

isRef 0 use required documentation The long name of the classification of the image

attribute SA/SEL_IMGS/SI/@note properties annotation

isRef 0 use required documentation Annotation from operator, may be blank

element SA/AUD diagram

properties

children annotation


0 0 1 complex

XE

documentation AUDit trail

element SA/AUD/XE diagram

properties

children annotation



ED

documentation Acceptor Entry

attribute SA/AUD/XE/@OP properties annotation


attribute SA/AUD/XE/@dt properties annotation

isRef 0 use required documentation date/time

attribute SA/AUD/XE/@EdFL type properties facets

annotation

restriction of xs:string isRef

0

Kind enumeration

Value T

enumeration

F

annotation

documentation Edit FLags (did the operator clear any flags, T/F?)

attribute SA/AUD/XE/@EdDEMOG type properties facets

annotation


0

Kind enumeration

Value T

enumeration

F

annotation

documentation Edit DEMOGraphics (did the operator edit any demographics, T/F?)

attribute SA/AUD/XE/@EdID type properties facets

annotation


0

Kind enumeration

Value T

enumeration

F

annotation

documentation Edit ID (did the operator alter the specimen ID, T/F?)

attribute SA/AUD/XE/@CM properties annotation

isRef

0

documentation Comment (if the operator changed it)

element SA/AUD/XE/ED diagram

properties

annotation

isRef 0 minOcc 0 maxOcc unbounded content complex documentation Edit Detail

attribute SA/AUD/XE/ED/@SN properties annotation

isRef 0 use required documentation Short Name of the analyte changed

attribute SA/AUD/XE/ED/@FROM properties annotation

isRef 0 use required documentation Analyte result before the change

attribute SA/AUD/XE/ED/@TO properties annotation

isRef 0 use required documentation Analyte result after the change

element SA/SysCfg diagram


isRef 0 content complex documentation System Configuration

attribute SA/SysCfg/@MicroPresent type

restriction of xs:string

isRef 0 use required Kind Value enumeration T

properties facets

enumeration

annotation

F

attribute SA/SysCfg/@AXPresent type

restriction of xs:string isRef 0 use required Kind Value enumeration T

properties facets

enumeration

annotation

F

attribute SA/SysCfg/@iChem200Present type

restriction of xs:string isRef 0 use required Kind Value enumeration T

properties facets

enumeration

annotation

F

element SA/SL diagram

isRef 0 minOcc 0 maxOcc 1 documentation Signature Line

properties

annotation

3. Specimen Information Query Message The instrument requests specimen information via the Specimen Information Query request message.

attribute form default: element form default:

Elements SIQ


element SIQ diagram

annotation

documentation Specimen Information Query, contains the specimen identifier for which to retrieve information from the LIS host

4. Specimen Information Response Message The LIS responds to to the instrument’s Specimen Information Query with the Specimen Information Response message.

attribute form default: element form default:


Elements SI

element SI diagram


content mixed

complex true

RCS DEMOG

documentation Specimen Information; contents are the specified specimen's identifier

attribute SI/@BF type properties facets

annotation

restriction of xs:string isRef 0 use required Kind Value enumeration URN enumeration

CSF

enumeration

PLE

enumeration

PER

enumeration

PED

enumeration

PEL

enumeration

PCA

enumeration

SER

enumeration

SYN

annotation documentation urine documentation cerebrospinal fluid documentation pleural fluid documentation peritoneal fluid documentation peritoneal dialysate documentation peritoneal lavage documentation pericardial fluid documentation serous fluid documentation synovial fluid

documentation Specimen type (Body Fluid type)

attribute SI/@WO type properties facets

restriction of xs:string isRef 0 use required Kind Value enumeration skip enumeration

gate

enumeration

run

enumeration

microonly chemonly

enumeration annotation

annotation documentation skip microscopy documentation use internal gating parameters to determine whether to run microscopy documentation run microscopy documentation only run microscopy documentation only run chemistry

documentation Work Order

element SI/RCS diagram

properties

children annotation


0 0 1 complex

RC

documentation RawChems holding the raw chemistry values from the LIS Host

element SI/RCS/RC diagram

type properties

annotation

extension of xs:string isRef 0 minOcc 12 maxOcc 13 content complex documentation Individual chemistry result in the element text; 12 or 13 (ascorbic is optional)

attribute SI/RCS/RC/@Key type properties facets

restriction of xs:string isRef 0 use required Kind Value enumeration BLD enumeration

BIL

enumeration

URO

enumeration

KET

enumeration

GLU

enumeration

PRO

enumeration

NIT

enumeration

LEU

enumeration

PH

enumeration

SG

enumeration

COL

enumeration

CLA

enumeration

ASA

annotation documentation Blood documentation Bilirubin documentation Urobilinogen documentation Ketone documentation Glucose documentation Protein documentation Nitrite documentation Leukocyte esterase documentation pH documentation Specific Gravity documentation Color documentation Clarity documentation Ascorbic Acid

element SI/DEMOG diagram

properties

annotation

isRef 0 minOcc 0 maxOcc 1 content complex documentation DEMOGraphics from the LIS Host

attribute SI/DEMOG/@LName type properties facets annotation


0

Kind maxLength

Value 26

annotation

documentation Last name

attribute SI/DEMOG/@FName type properties facets annotation


0

Kind maxLength

Value 26

annotation

documentation First name

attribute SI/DEMOG/@MName type properties facets annotation


0

Kind maxLength

Value 26

documentation Middle name

annotation

attribute SI/DEMOG/@DOB type


properties

0

Kind length

Value 10

pattern

[0-9][0-9][0-9][0-9]-[0-9][ [0-9][0-9][0-9][0-9]-[0-9][0-9]-[0-9][0-9] 0-9]-[0-9][0-9]

facets

annotation

documentation Date of birth (YYYY-MM-DD)

annotation

attribute SI/DEMOG/@Loc type


properties

0

Kind maxLength

facets

Value 26

annotation

documentation Location

annotation

attribute SI/DEMOG/@RecNum type


properties

0

Kind maxLength

facets

Value 26

annotation

documentation Medical record number

annotation

attribute SI/DEMOG/@Gender type


properties facets

0

Kind enumeration

Value M

enumeration

F

annotation

documentation Gender (M/F)

annotation

5. Specimen Information Response Message for Unrecognized Specimen Identifier The LIS host responds to the instrument’s Specimen Information Query with the UNKID message when the host does not recognize the supplied specimen identifier. attribute form default: element form default:

Elements UNKID


element UNKID diagram

type

xs:string

content


simple

documentation The LIS Host did not recognize the specimen ID (UNKnown ID); the unrecognized ID is in the element text

6. Chemistry Control Report Message The instrument reports chemistry control results with the Chemistry Control Report message.

Attribute form default: element form default:

Elements ChemQC


element ChemQC diagram


content

complex

PF QCR CM

documentation ChemistryQualityControl root element.

attribute ChemQC/@NAME type properties annotation

xs:string

isRef 0 use required documentation The control name, e.g., "CA"

attribute ChemQC/@SID type properties annotation

xs:string


attribute ChemQC/@OP properties annotation


attribute ChemQC/@ADT type properties annotation

xs:string

isRef 0 use required documentation Analysis DateTime with time zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute ChemQC/@ADTS type properties annotation

xs:string


attribute ChemQC/@RDT type properties annotation

xs:string

isRef 0 use required documentation Report DateTime with time zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute ChemQC/@RDTS type properties annotation

xs:string


attribute ChemQC/@LOT type

xs:string


isRef 0 use required documentation Control lot

attribute ChemQC/@EXPIR type properties annotation

xs:string

isRef 0 use required documentation Lot expiration

attribute ChemQC/@DSID type properties annotation

xs:string

isRef 0 use required documentation Dipstick lot ID

attribute ChemQC/@DSEXPIR type properties annotation

xs:string

isRef 0 use required documentation Dipstick lot expiration

attribute ChemQC/@RP type properties annotation

xs:integer

isRef 0 use optional documentation Rack position (tube number in the rack)

attribute ChemQC/@STATUS type properties annotation

xs:string

isRef 0 use required documentation Pass (P) or Fail (F)

element ChemQC/PF diagram

type properties

xs:string


0 0 unbounded simple

element ChemQC/QCR diagram

type properties

annotation

extension of xs:string isRef 0 minOcc 1 maxOcc unbounded content complex documentation QC Result

attribute ChemQC/QCR/@SN type properties annotation

xs:string

isRef 0 use required documentation Short Name of the analyte

attribute ChemQC/QCR/@LN properties annotation

isRef 0 use required documentation Long Name of the analyte

attribute ChemQC/QCR/@ISTATUS type properties facets

annotation

restriction of xs:string isRef 0 use required Kind Value enumeration P enumeration

F

enumeration

-

documentation Pass (P), Fail (F), ignore (-)

attribute ChemQC/QCR/@LL properties

annotation

isRef use

0 required

annotation

documentation Lower Limit

attribute ChemQC/QCR/@UL properties annotation

isRef 0 use required documentation Upper Limit

attribute ChemQC/QCR/@UNIT properties annotation

isRef 0 use optional documentation Unit of measure (if not already in result)

element ChemQC/CM diagram

type properties

annotation

xs:string


7. C ount Co C ontrol R epor t Me M essag ssage The instrument reports count control results with the Count Control Report message. attribute form default: element form default:

Elements CQC


element CQC diagram


content

complex

PF MIN MAX COUNT STATUS COUNT STATUS REF CM

documentation CountQualityControl root element.

attribute CQC/@CCType type properties facets

annotation

restriction of xs:string isRef 0 use required Kind Value enumeration +L enumeration

-L

enumeration

+L2

enumeration

-L2

annotation

documentation +L=Primary Positive Count Control; -L=Primary Negative Count Control; +L2=Secondary Positive Count Control; -L2=Secondary Negative Count Control

attribute CQC/@ID type properties annotation

xs:string

isRef 0 use required documentation The control ID

attribute CQC/@SID type properties annotation

xs:string


attribute CQC/@OP properties annotation


attribute CQC/@ADT type properties annotation

xs:string


attribute CQC/@ADTS type properties annotation

xs:string


attribute CQC/@RDT type properties annotation

xs:string

isRef 0 use required documentation Report DateTime with time zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute CQC/@RDTS type properties annotation

xs:string


attribute CQC/@LOT type properties annotation

xs:string


attribute CQC/@EXPIR type properties annotation

xs:string


attribute CQC/@PRODID type properties annotation

xs:string

isRef 0 use required documentation Product ID of the control

attribute CQC/@MEAN type properties annotation

xs:integer

isRef 0 use required documentation Mean value

attribute CQC/@MNC type properties annotation

xs:integer

isRef 0 use optional documentation Maximum negative count (the maximum count for a negative control)

attribute CQC/@RP type properties annotation

xs:integer


attribute CQC/@SQN type properties annotation

xs:integer

isRef 0 use optional documentation Sequence Number

attribute CQC/@RSQN type properties annotation

xs:integer

isRef 0 use optional documentation Rack Sequence Number (rack ID)

element CQC/PF diagram

type properties

xs:string



element CQC/MIN diagram


xs:integer

isRef 0 content simple documentation Minimum to pass

element CQC/MAX diagram


xs:integer

isRef 0 content simple documentation Maximum to pass

element CQC/COUNT diagram


xs:integer

isRef 0 content simple documentation Actual count

element CQC/STATUS diagram

type properties facets

restriction of xs:string isRef 0 content simple Kind Value enumeration P enumeration

annotation

F

documentation Pass (P) or Fail (F)

element CQC/REF diagram


xs:double

isRef 0 content simple documentation Run Equivalency Factor

element CQC/CM diagram

type properties

annotation

xs:string


annotation

8. B ody F luid lui d Contr Contr ol R epor t Me M essag ssag e The instrument reports body fluid control results with the Body Fluid Control Report message. attribute form default: element form default:

Elements BFQC


element BFQC diagram

properties children

annotation

content

complex

PF RBCMIN RBCMAX RBCCOUNT NUCMIN RBCCOUNT NUCMIN NUCMAX NUCCOUNT STATUS REF CM

documentation BodyFluidQualityControl root element.

attribute BFQC/@BFCType type properties facets

annotation

restriction of xs:string isRef 0 use required Kind Value enumeration BGC enumeration

BL1

enumeration

BL2

annotation

documentation BGC=BFA Background Check; BL1=BFA Level I Control; BL2=BFA Level II Control

attribute BFQC/@ID type properties annotation

xs:string

isRef 0 use required documentation The control ID

attribute BFQC/@SID type properties annotation

xs:string


attribute BFQC/@OP properties annotation


attribute BFQC/@ADT type properties annotation

xs:string


attribute BFQC/@ADTS type properties annotation

xs:string


attribute BFQC/@RDT type properties annotation

xs:string

isRef 0 use required documentation Report DateTime with t ime zone info (YYYY-MM-DD HH:MM:SStz, where an example of tz is "-8:00" for Pacific time)

attribute BFQC/@RDTS type properties annotation

xs:string


attribute BFQC/@LOT type properties annotation

xs:string


attribute BFQC/@EXPIR type properties annotation

xs:string


attribute BFQC/@PRODID type properties annotation

xs:string

isRef 0 use required documentation Product ID of the control

attribute BFQC/@RBCMEAN type properties annotation

xs:integer

isRef 0 use required documentation Mean RBC value

attribute BFQC/@NUCMEAN type properties annotation

xs:integer

isRef 0 use required documentation Mean nucleated value

attribute BFQC/@RP type properties annotation

xs:integer


attribute BFQC/@SQN type properties annotation

xs:integer

isRef 0 use optional documentation Sequence Number

attribute BFQC/@RSQN type properties annotation

xs:integer

isRef 0 use optional documentation Rack Sequence Number (rack ID)

element BFQC/PF diagram

type properties

xs:string



element BFQC/RBCMIN diagram


xs:integer

isRef 0 content simple documentation Minimum RBC to pass

element BFQC/RBCMAX diagram


xs:integer

isRef 0 content simple documentation Maximum RBC to pass

element BFQC/RBCCOUNT diagram


xs:integer

isRef 0 content simple documentation Actual RBC count

element BFQC/NUCMIN diagram


xs:integer

isRef 0 content simple documentation Minimum NUC to pass

element BFQC/NUCMAX diagram


xs:integer

isRef 0 content simple documentation Maximum NUC to pass

element BFQC/NUCCOUNT diagram


xs:integer

isRef 0 content simple documentation Actual NUC count

element BFQC/STATUS diagram

type properties facets

restriction of xs:string isRef 0 content simple Kind Value enumeration P enumeration

annotation

F

documentation Pass (P) or Fail (F)

annotation

element BFQC/REF diagram


xs:double

isRef 0 content simple documentation Run Equivalency Factor

element BFQC/CM diagram

type properties

annotation

xs:string


APPENDIX A

Additional Tables

The following table lists the Test Identifiers/Upload codes (in the Test column) for all tests that correspond to each Simple Panel that makes up the Predefined Panel listed in Table A.1, Predefined Panel Identifiers Table A.1 Test Identifiers/Upload codes

Panel

Specimen Type

Tests

Description

UA Chemistry

Urine

BLD

Blood

BIL

Bilirubin

URO

Urobilinogen

KET

Ketone

GLU

Glucose

PRO

Protein

NIT

Nitrite Nitri te

LEU

Leukocytes

PH

pH

SG

Specific Gravity

COL

Color

CLA

Clarity

ASA

Ascorbic Acid

Table A.1 Test Identifiers/Upload codes (Continued)

Panel

Specimen Type

Tests

Description

UA Microscopy

Urine

ART

Artifact

RBC

Red Blood Cell

DRBC

Dysmorphic Red Blood Cell

WBC

White Blood Cell

WBCC

White Blood Cell Clump

BACT

Bacteria

BYST

Budding Yeast

HYST

Hyphae Yeast

SQEP

Squamous Epithelial

TREP

Transitional Epithelial

REEP

Renal Epithelial

OVFB

Oval Fat Body

FAT

Fat

MUCS

Mucous

RBCC

Red Blood Cell Clump

SPRM

Sperm

TRCH

Trichomonas

NSE

Non-Squam Non-Squamous ous Epithelial Epithelial

UNCC

Unclassified Cast

HYAL

Hyaline Cast

EPIC

Epithelial Cast

WBCT

White Blood Cell Cast

RBCT

Red Blood Cell Cast

GRAN

Granular Cast

CELL

Cellular Cast

BROAD

Broad Cast

FATC

Fatty Cast

WAXY

Waxy Cast

UNCX

Unclassified Crystal

TPO4

Triple Phosphate Crystal

CAOX

Calcium Oxalate

CAPH

Calcium Phosphate Crystal

CACB

Calcium Carbonate

URIC

Uric Acid Crystal

LEUC

Leucine Crystal

Body Fluid

Cerebrospinal Fluid Pleural Fluid Peritoneal dialysate Peritoneal lavage Pericardial Fluid Serious Fluid Synovial Fluid

CYST

Cystine Crystal

TYRO

Tyrosine Crystal

AMOR

Amorphous Crystal

UNCL

Unclassified

ASP

All Small Particle

RBC

Red Blood Cells

NUCL

Nuclea Nucleated ted Cells Cells

UNCX

Crystal

BACT

Bacteria

LOINC

Codes

The following table lists the LOINC codes. Table A.2 LOINC Codes

APPENDIX B

Sample Messages

The communications consists of ASCII-encoded XML messages transmitted between the instrument system manager and the laboratory information system (LIS) over an ASTM-E 1381-95 low-level protocol. Messages from the instrument fall into one of two categories: reports or queries. Reports are informational, expecting no response from the LIS. Queries, however, expect a reply from the LIS. The only time the host sends a message to the instrument is in reply to a query. The messages are in Unicode and ASCII-encoded. ASCII encoding takes the hexadecimal representation of each byte of the Unicode message and sends that representation in ASCII. For example, “CAT” has a non -Unicode hexadecimal representation as 434154, which in Unicode is 430041005400, so it would be transmitted as “430041005400”.

The following are examples of messages transmitted between the System Manager and the laboratory information system.

Verification Example Communication: 13C004900520049005300500069006E0067002F003E000D000A00C4 Data:

Specimen Information Query Example Communication: 13C005300490051003E0037003000370031003000390030003100380037003C002F0053004900 51003E000D000A0089 Data: <7071090187

Specimen Information Response Example Data: 7071090187

Specimen Information Response for Unrecogniz Unrecognized ed Specimen Identifier Example Data: 1529934

Specimen Analysis Report Example Data: Iris Diagnostics9172 Eton AveChatsworth, CA 91311+4+3 mg/dL-+1 mg/dL5.0---25 Leu/uLClear1.0001.000Yellow[none][none]Not Detected[none][none]None Seen[none]NONE DETECTED+[none][none][none]1 /uL[none]1 /uL[none]1 /uL[none]1 /uL[none][none][none][none][none][none]4 /LPF[none][none][none][none][none][none]RARE[none][none][none][none][none][none]
SN="CYST" LN="Cystine Crystal" AF="0" NR="POS">[none][none][none][none][none] Urine Culture Recommended42Signature

Chemistry Control Report Example Data: Iris Diagnostics9172 Eton AveChatsworth, CA 91311800.776.4747+2 (0.2 mg/dL)+1 (1 mg/dL)Normal-+2 (200 mg/dL)+3 (600 mg/dL)-Negative8.51.012GreenClear

Count Control Report Example Data: IRISChatsworth, California 8041206921P2.265

Body Fluid Control Report Example Data: Iris LIS Laboratory917 2 Eton AveChatsworth, CA 91311800.776.474733670 62530298311889< NUCMAX>35102496F< REF>2 .408

APPENDIX C

Glossary

This glossary is a collection of specialized terms and their meanings that are either used in this manual or related to the information in it. If a term has more than one meaning, all meanings relevant to this manual are included.

Acknowledgment [C1] The most significant character of Checksum [C2] The least significant character of Checksum Carriage Return

[DA TA] ecor d The data contents of the r ecor

Inquire End of Transmission

End of Transmission Block. For use only when a single record is too large to fit into one frame. End of Text. Required at the end of each record.

Frame communication housekeeping housekeeping such as error A subdivision of a message, used to allow periodic communication checks and acknowledgement [frame number] Single digit frame number “0” to “7.” Star ts with ts with “1.” Line feed ne feed

Negative Acknowledgment

Start of Frame An alyze yzer ™

iQ®200 Automated Urinalysis Series, iRICELL ® Automated Urinal Urinalysis ysis workcells, workcells, iChe iC hem m®Velocity analyzer ASTM The American Society for Testing and Materials ASCII American Standard Code for Information Interchange XML Extensible Markup Language

Unicode Unicode is a standard a standard for the consistent encoding, consistent encoding, representation, representation, and handling of text text expressed in most of the the world's writing world's writing systems. Communications Packet All framing required for transmission of data. This framing includes: [frame [frame number][DATA] [ or ][C1][C2] . Component Field A single data element or data elements that express a finer aggregate or extension of data elements which precede it. Components cannot contain repeat fields. LIS

La bor atory Information tory Information System. (Laboratory com puter ) Download The transmission of data from the LIS to the analyzer workstation

WO Work Order

Upload The transmission of data from the Instrument to the LIS

IQ 200 Host Transmission Manual Rev JA

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