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Prévia do material em texto

全自动生化分析仪软件 
Zybio LIS 协议 
 
 
文件编号 EXC200-T-001 版本 A0 
编制 软件工程师 日期 
审核 技术主管 日期 
批准 项目经理 日期 
 
 
 
Manual of LIS Protocol Interface 
1 Terms 
This protocol applies to the Chemistry Analyzer Software developed by Zybio Inc. (herein 
after referred to as Zybio). Relevant terms are as follows: 
Manufacturer: Zybio 
Product model: EXC200 
2 HL7 underlying protocol 
The Transmission Control Protocol and the Internet Protocol (TCP/IP) is a byte-stream 
protocol not providing message boundaries, while Health Level Seven (HL7), as the upper-
layer protocol, is a message-oriented protocol not providing message termination 
mechanism. The minimum underlying protocol, HL7 Interface Standards Version 2.3.1 
(description of this protocol is given in the following paragraphs), is used to define the 
message boundaries. 
The communication layer messages are transmitted in the format of: 
<SB> ddddd <EB><CR> 
Where 
<SB> = Start Block character (1 byte) 
ASCII, i.e., <0x0B>. Do not confuse it with the ASCII characters of SOH or STX. 
ddddd = Data (variable number of bytes) 
ddddd is an HL7 message, including only the ISO 8859-1 characters (hexadecimal 
value 20-ff) and <CR>, but not control characters or nonprinting characters. 
<EB> = End Block character (1 byte) 
ASCII <FS>, i.e., <0x1C>. Do not confuse it with the ASCII characters of ETX or 
EOT. 
<CR> = Carriage Return (1 byte) 
ASCII carriage return, i.e., <0x0D>. 
Start character: hexadecimal <0B> 
End character: hexadecimal <1C><0D> 
3 Supported HL7 messages 
ORU messages, ACK messages, QRY messages, QCK messages, and DSR messages. 
 
Uploading of test results: 
 
Acquisition of the sample application from LIS: 
 
ORU/ACK: unsolicited observation results/responses. ORU^R01 message is mainly 
intended to transmit laboratory results in HL7. It is used to transmit the sample 
information, the test results, and the quality control results to the LIS. 
The transmitted information and test results include: 
 Patient information (patient name, age, etc.); 
 Medical advice (sample type, submitter, examination physician, clinical 
diagnosis, etc.); 
 Test result. 
It is a group of messages. Each message corresponds to the information of a sample (may 
be with test results of multiple items). LIS can retrieve these contents according to 
requirements. The sample information and test results are transmitted in the format as 
follows: 
ORU Observational Results 
(Unsolicited) 
Description 
MSH Message header 
PID Patient information 
OBR Observation report 
 
ORU Observational Results 
(Unsolicited) 
Description 
{OBX} Test result 
 
The calibration results include: 
 Item information (item number and item name); 
 Calibration rule and calibration time; 
 Calibrator information (quantity, catalog number, name, batch number, 
expiration date, concentration, etc.); 
 Calibration result (reactivity, and the number and value of calibration 
parameters). 
One message contains all the calibration results of one item. LIS can retrieve these 
contents according to requirements. The calibration results are transmitted in the format 
as follows: 
ORU Observational 
Results (Unsolicited) 
Description 
MSH Message header 
OBR Calibration observation report 
 
The quality control results include: 
 Item information (item number and item name); 
 Control information (quantity, catalog number, name, batch number, 
expiration date, mean value, etc.); 
 QC time and result (concentration value). 
One message contains all the quality control test results of one item. LIS can retrieve these 
contents according to requirements. 
The QC results are transmitted in the format as follows: 
ORU Observational 
Results (Unsolicited) 
Description 
MSH Message header 
 
ORU Observational 
Results (Unsolicited) 
Description 
OBR QC observation report 
 
ACK^R01 messages are the response to ORU messages. They are transmitted in the 
format as follows: 
ACK Acknowledgment Description 
MSH Message header 
MSA Message affirmation 
 
QRY^Q02 messages are intended to query the current data. Triggered by the event Q02, 
they are used to query the requested sample application information in the LIS. They are 
transmitted in the format as follows: 
QRY Query Description 
MSH Message header 
QRD Query definition 
QRF Query filter 
 
QCK^Q02 messages are the response to QRY messages. They are transmitted in the 
format as follows: 
QCK Query 
Acknowledgment 
Description 
MSH Message header 
MSA Message acknowledgment 
ERR Error 
QAK Query acknowledgment 
 
 
DSR/ACK: response to QRY messages and display/ response to observation results. One 
of the functions of DSR^Q03 messages is to respond to the QRY messages. In addition, 
DSR^Q03 messages transmit and display the query results, that is, the LIS transmits the 
requested sample application information to the Chemistry Analyzer. They are transmitted 
in the format as follows: 
DSR Display Response Description 
MSH Message header 
MSA Message acknowledgment 
ERR Error 
QAK Query acknowledgment 
QRD Query definition 
QRF Query filter 
{DSP} Display data 
DSC Continuation pointer 
 
QCK^Q03 messages are the response to DSR messages. They are transmitted in the 
format as follows: 
ACK Acknowledgment Description 
MSH Message header 
MSA Message acknowledgment 
ERR Error 
 
4 Message segment 
Special rule: all time information in the protocol is transmitted in the format of 
“yyyyMMddhhmmss” without any separation, that is, “Year, Month, Day, Hour, Minute, 
Second”. For example, “20210722094815” denotes “09:48:15, July 22nd, 2021.” 
 
4.1 MSH - message header 
The first segment of HL7 message. All messages start with the MSH located at their very 
beginning. This message segment defines the intention, source, and purpose of the 
message, and the details of message syntax. 
No. Field Description 
1# Field Separator Contains the separator between the 
segment ID and the first true domain, and 
the domain separators defining the 
remaining part of the message. (|) 
2# Encoding Characters Contains component separators, repeat 
separators, escaping separators, and sub-
component separators. ( ^~\& ) 
3# Sending Application Sender application, taking the 
manufacturer name. 
4 Sending Facility Sender device, taking the device model. 
5 Receiving Application Leave empty and reserved. Receiver 
application. 
6 Receiving Facility Leave empty and reserved. Receiver 
device. 
7 Date/Time Of Message Current message time. Invokes the system 
time information. 
8 Security Leave empty and reserved. Security 
9# Message Type Message type, such as ORU^R01. 
10# Message Control ID Message control ID, the unique identifier of 
a message. It increases incrementally from 
1 along with the quantity of messages. 
11# Processing ID Processing ID, always taking P (stands for 
product). 
12# Version ID Version ID. HL7 protocol version: 2.5. 
 
No. Field Description 
13 Sequence Number Leave empty and reserved. Sequence 
number 
14 Continuation Pointer Continuation pointer. Empty denotes the 
last message. 
15 Accept Acknowledgment 
Type 
Accept Acknowledgment Type, only valid to 
DSR^Q03 messages. Takes P as the 
value, denoting the sample information 
sent by LIS. Other values indicate the 
information responding to the query in LIS 
and can be left empty. 
16 Application Acknowledgment 
Type 
Application Acknowledgment Type, the 
type of the sent result. 0 - patient sample 
test results; 1 - calibration results; 2 - QC 
results; 3 - QC summary. 
17 Country Code Leave empty and reserved. Country code 
18 Character Set Character set, taking UNICODE. 
19 Principal Language Of 
Message 
Leave empty and reserved. Principal 
language of message 
20 Alternate Character Set 
Handling Scheme 
Leave empty and reserved. Alternatecharacter set handling scheme 
21 Message Profile Identifier Leave empty and reserved. Message 
profile identifier 
 
Example: 
When the software sends the sample test results to the LIS, the result type is “0”, and the 
sending time is “20210105104254”: 
MSH|^~\&|Zybio|EXC200|||20210105104254||ORU^R01|650|P|2.5||||0||UNICODE||| 
//Allows LIS server not to return a response 
 
4.2 MSA - message acknowledgment segment 
No. Field Description 
1# Acknowledgment Code Acknowledgment code. AA denotes accepted; 
AE denotes error; AR denotes rejected; OK 
indicates the data found, and NF indicates the 
data not found. OK and NF are valid only in 
DSR^Q03. 
2# Message Control ID Message control ID, the same with the MSH-
10 of sender. 
3 Text Message Text message, a description of an event when 
there is an error or a rejection. It corresponds 
to the 6th field and can be written in the error 
log. 
4 Expected Sequence 
Number 
Leave empty and reserved. Expected 
sequence number 
5 Delayed Acknowledgment 
Type 
Leave empty and reserved. Delayed 
acknowledgment type 
6 Error Condition Error condition (state code). 
4.3 Values of the MSA-6 field 
State code (MSA-6) State code (MSA-3) Description/Remarks 
Success AA 
0 Message accepted Success 
Successful query OK 
0 Data found, no 
errors 
Successful query 
Query does not find 
the data. 
 NF 
 
State code (MSA-6) State code (MSA-3) Description/Remarks 
0 Data found, no errors Query does not find the 
data. 
Code of error state AE 
100 Segment sequence error The segment sequence in 
the message is incorrect, or 
the required segment is 
missing. 
101 Required field missing The required field in a 
segment is missing. 
102 Data type error Incorrect data type of the 
field, for example, the data 
type of number is mistaken 
as a character. 
103 Table value not found Table value not found, 
temporarily not used. 
Code of rejection 
state 
 AR 
200 Unsupported message type Unsupported message type 
201 Unsupported event code Unsupported event code 
202 Unsupported processing id Unsupported processing id 
203 Unsupported version id Unsupported version id 
204 Unknown key identifier Unknown key identifier, such 
as to transmit the 
information of an unknown 
patient. 
205 Duplicate key identifier Duplicate key identifier 
206 Application record locked The transaction cannot be 
executed at application 
 
State code (MSA-6) State code (MSA-3) Description/Remarks 
record level, such as when 
the database is locked. 
207 Application internal error Unknown application internal 
error 
4.4 PID - patient identification 
PID segment is mainly used to constitute the patient profile. The PID segment of this 
interface uses the following domains: 
No. Field Description 
1 Set ID –PID Defines the message segments of different 
patients. 
2 Patient ID Admission number 
3# Patient Identifier List Patient ID 
4 Alternate Patient ID_PID Bed No. 
5# Patient Name Patient name 
6 Mother’s Maiden Name Leave empty and reserved. Mother’s maiden 
name 
7 Date/Time of Birth Birth date of patient. Used as age and age 
unit. The age and age unit are separated by 
^. The age is an integer; the age unit is a 
string. Y stands for Year, M stands for 
Month, W stands for Week, D stands for 
Day, and H stands for Hour. 
8 Sex Gender. M stands for Male, F stands for 
Female, O stands for Others, and U stands 
for Unknown. 
9 Patient Alias Blood types, including A, B, AB, O, and U (U 
denotes other blood types). 
10 Race Race, used as special blood types, including 
 
No. Field Description 
RhD(+) and RhD(-). 
11 Patient Address Leave empty and reserved. Patient address 
Used as remarks 
12 Country Code Leave empty and reserved. County code 
(Postal code). 
13 Phone Number-Home Leave empty and reserved. Phone number 
14 Phone Number-Business Leave empty and reserved. Leave empty 
and reserved. Phone number 
15 Primary Language Leave empty and reserved. Leave empty 
and reserved. Principal language 
16 Marital Status Leave empty and reserved. Leave empty 
and reserved. Marital status 
17 Religion Leave empty and reserved. Leave empty 
and reserved. Religion 
18 Patient Account Number Leave empty and reserved. Patient type 
19 SSN Number -Patient Leave empty and reserved. Medical 
insurance account 
20 Driver's License Number –
Patient 
Leave empty and reserved. Driver's license 
number 
21 Mother's Identifier Leave empty and reserved. Mother’s 
identifier 
22 Ethnic Group Leave empty and reserved. Ethnic group 
23 Birth Place Leave empty and reserved. Birth place 
24 Multiple Birth Indicator Leave empty and reserved. Multiple birth 
indicator. Y stands for Yes, and N stands for 
No. 
 
No. Field Description 
25 Birth Order Leave empty and reserved. Birth order, an 
integer greater than 0. 
26 Citizenship Leave empty and reserved. Identification 
number 
27 Veterans Military Status Leave empty and reserved. Veteran status 
28 Nationality Leave empty and reserved. Country 
29 Patient Death Date and Time Leave empty and reserved. Patient death 
time 
30 Patient Death Indicator Leave empty and reserved. Patient death 
indicator. Y stands for Yes, and N stands for 
No. 
31 Identity Unknown Indicator Leave empty and reserved. Identity 
unknown indicator 
 
Example: 
Field meaning Value 
Patient ID 
1111 
Patient name 
ZHANG San 
Age 
60 
Sex 
Male 
Blood type 
A 
The software sends the following PID segment to the LIS. 
PID|1||1111||ZHANG San||60^Y|M|A|||||||||||||||||||||||||||||| 
4.5 OBR - observation request 
OBR segment transmits the doctor’s advice about the test report. 
 
4.5.1 Sample test result 
The following domains are used to transmit the information of sample test results (take 0 
as MSH-16). 
No. Field Description 
1 Set ID –OBR Defines the fields of different OBR. 
2 Placer Order Number Placer order number, used as the sample 
barcode. 
3 Filler Order Number Filler order number, used as the serial code. 
4# Universal Service ID Universal service ID, taking manufacture 
name^device model. 
5 Priority Emergency or not. STAT denotes Yes, and 
empty string denotes No. 
6 Requested Date/time Requested time and date, used as sampling 
time. 
7 Observation Date/time Observation time and date, used as 
application/test time. 
8 Observation End Date/Time Leave empty and reserved. Date of 
observation end. 
9 Collection Volume Collected sample volume, used as manual 
dilution factor. 
10 Collector Identifier Collector identifier, used as sample position 
(comprising sample disk number ^cuvette 
number). 
11 Specimen Action Code Leave empty and reserved. Specimen action 
code 
12 Danger Code Danger code, denoting whether to dilute. 
Leave empty and reserved. 
13 Relevant Clinical Info Relevant clinical information, used as clinical 
 
No. Field Description 
diagnosis of patient. 
14 Specimen Received 
Date/Time 
Submission date/time 
15 Specimen Source Sample source, used as sample type. 
Serum - SERUM, plasma - PLASMA, urine - 
URINE, whole blood - WH_BLOOD, pleural 
and peritoneal fluids - PPF, others - OTHER. 
Send text for more user-defined samples. 
16 Ordering Provider Provider of doctor’s advice, used as 
submitter. 
17 Order Callback Phone 
Number 
Used as inspection department. 
18 Placer Field 1 Leave empty and reserved. Sample 
properties (jaundice, hemolysis, and lipemia) 
19 Placer Field 2 Leave empty and reserved. Reviewer 
20 Filler Field 1 Physician-in-charge, used as examination 
physician. 
21 Filler Field 2 Leave empty and reserved. Therapy 
department 
22 Result Rpt/Status Change-
Date/Time 
Leave empty and reserved. Result report 
date/time. 
23 Charge to Practice Leave empty and reserved. Charge to 
practice 
24 Diagnostic Serv Sect ID Leave empty and reserved. Diagnostic 
section ID 
25 Result Status Leave empty and reserved. Result status26 Parent Result Leave empty and reserved. Parent order 
result 
 
No. Field Description 
27 Quantity/Timing Leave empty and reserved. Quantity / time 
28 Result Copies To Leave empty and reserved. Result copies to. 
29 Parent Leave empty and reserved. Parent order 
30 Transportation Mode Leave empty and reserved. Transportation 
mode 
31 Reason for Study Leave empty and reserved. Reason for 
study 
32 Principal Result Interpreter Principal result interpreter, used as the 
reviewer. 
33 Assistant Result Interpreter Leave empty and reserved. Assistant result 
interpreter 
34 Technician 
Leave empty and reserved. Technician 
35 Transcriptionist 
Leave empty and reserved. Transcription 
36 Scheduled Date/Time 
Leave empty and reserved. Scheduled date 
37 Number of Sample 
Containers 
Leave empty and reserved. Quantity of 
sample containers 
38 Transport Logistics of 
Collected Sample 
Leave empty and reserved. Transportation 
logistics of collected samples 
39 Collector’s Comment 
Leave empty and reserved. Collector’s 
comment 
40 Transport Arrangement 
Responsibility 
Leave empty and reserved. Transportation 
arrangement responsibility 
41 Transport Arranged 
Leave empty and reserved. Whether to 
arrange transportation 
42 Escort Required 
Leave empty and reserved. Escort is 
required. 
 
No. Field Description 
43 Planned Patient Transport 
Comment 
Leave empty and reserved. Transportation 
comment for planned patient. 
44 Procedure Code 
Leave empty and reserved. Procedure code 
45 Procedure Code Modifier 
Leave empty and reserved. Procedure code 
modifier 
46 Placer Supplemental Service 
Information 
Leave empty and reserved. Supplemental 
service information 
47 Filler Supplemental Service 
Information 
Leave empty and reserved. Fill the 
supplemental service information. 
48 Medically Necessary 
Duplicate Procedure Reason. 
Leave empty and reserved. Medically 
necessary duplicate procedure reason. 
49 Result Handling 
Leave empty and reserved. Result handling 
Example: 
Field meaning Value 
Sample bar code 123456 
Serial code 1 
Sample type Serum 
Sample position Disk No.1, cuvette No.2 
The software sends the following OBR message segment to the LIS. 
OBR|1|123456|1|Zybio^EXC200||20201130090600|20201130090608|||1^1||||2020113008
0000|SERUM||||Engineer|||||||||||||||||||||||||||||| 
4.5.2 Calibration result 
When transmitting the item calibration result (take 1 as MSH-16), the field is defined as 
follows: 
No. Field Description 
1 Set ID –OBR Defines the fields of different OBR. 
 
No. Field Description 
2 Placer Order Number Placer order number, used as the item 
number. 
3 Filler Order Number Filler order number, used as the item 
name. 
4# Universal Service ID Universal service identifier, used as 
manufacturer name ^device model. 
5 Priority Leave empty and reserved. Priority 
6 Requested Date/time Leave empty and reserved. Request time 
7 Observation Date/time Observation time and date, used as 
calibration time. 
8 Observation End Date/Time Leave empty and reserved. Date of 
observation end. 
9 Collection Volume Used as calibration rule. 0 - linearity 
(single-point linearity, two-point linearity, 
multi-point linearity); 1-Logistic-Log4P; 2-
Logistic-Log5P; 3-Exponential 5P; 4-
Polynomial 5P; 5-Spline; 6-k_factor. 
10 Collector Identifier Leave empty and reserved. Collector’s 
identifier 
11 Specimen Action Code Quantity of calibrators 
12 Danger Code Calibrator code 
13 Relevant Clinical Info Calibrator name 
14 Specimen Received Date/Time Calibrator batch No. 
15 Specimen Source Calibrator valid date 
16 Ordering Provider Standard calibrator concentration 
17 Order Callback Phone Number Calibrator concentration level 
 
No. Field Description 
18 Placer Field 1 Reactivity 
19 Placer Field 2 Number of calibration parameters 
20 Filler Field 1 Value of calibration parameter 
21 Filler Field 2 Leave empty and reserved. 
22 Result Rpt/Status Change-
Date/Time 
Leave empty and reserved. Result report 
date / time. 
23 Charge to Practice Leave empty and reserved. Charge to 
practice 
24 Diagnostic Serv Sect ID Leave empty and reserved. Diagnostic 
section 
25 Result Status Leave empty and reserved. Result status 
26 Parent Result Leave empty and reserved. Parent order 
result 
27 Quantity/Timing Leave empty and reserved. Quantity / time 
28 Result Copies To Leave empty and reserved. Result copies 
to. 
29 Parent Leave empty and reserved. Parent order 
30 Transportation Mode Leave empty and reserved. Transportation 
mode 
31 Reason for Study 
Leave empty and reserved. Reason for 
study 
32 Principal Result Interpreter 
Principal result interpreter, used as the 
reviewer. 
33 Assistant Result Interpreter Leave empty and reserved. Assistant result 
interpreter 
34 Technician Leave empty and reserved. Technician 
 
No. Field Description 
35 Transcriptionist Leave empty and reserved. Transcription 
36 Scheduled Date/Time Leave empty and reserved. Scheduled 
date 
37 Number of Sample Containers Leave empty and reserved. Quantity of 
sample containers 
38 Transport Logistics of 
Collected Sample 
Leave empty and reserved. Transportation 
logistics of collected samples 
39 Collector’s Comment Leave empty and reserved. Collector’s 
comment 
40 Transport Arrangement 
Responsibility 
Leave empty and reserved. Transportation 
arrangement responsibility 
41 Transport Arranged Leave empty and reserved. Whether to 
arrange transportation 
42 Escort Required Leave empty and reserved. Escort is 
required. 
43 Planned Patient Transport 
Comment 
Leave empty and reserved. Transportation 
comment for planned patient. 
44 Procedure Code Leave empty and reserved. Procedure 
code 
45 Procedure Code Modifier Leave empty and reserved. Procedure 
code modifier 
46 Placer Supplemental Service 
Information 
Leave empty and reserved. Supplemental 
service information 
47 Filler Supplemental Service 
Information 
Leave empty and reserved. Fill the 
supplemental service information. 
48 Medically Necessary Duplicate 
Procedure Reason. 
Leave empty and reserved. Medically 
necessary duplicate procedure reason. 
 
No. Field Description 
49 Result Handling Leave empty and reserved. Result 
handling 
According to the quantity of calibrators, the content of the 12th to 18th fields is in the format 
of: 
V1^V2^ …Vi. For the 20th field, the values are separated by ^ according to the number of 
calibration parameters. 
For different calibration rules, there are different calibration parameters. 
For single-point linear calibration, two-point linear calibration, multi-point linear calibration, 
and K-f Method (k_factor), there are two calibration parameters, i.e., K and R0; 
For Logistic-Log4P, there are four calibration parameters, i.e., K, R0, a, and b; 
For Logistic-Log5P and Exponential 5P, there are five calibration parameters, i.e., K, R0, 
a, b, c; 
For Polynomial 5P, there are five calibration parameters, i.e., R0, a, b, c, and d; 
For Spline, there are 4*(n-1) calibration parameters, i.e., R0i, ai, bi, and ci. Where n 
denotes the quantity of calibrators. 
4.5.3 QC result 
When transmitting the QC data result (take 2 as MSH-16), the field is defined as follows: 
No. Field Description 
1 Set ID –OBR Defines the fields of different OBR. 
2 Placer Order Number 
Placer order number, used as the item 
number. 
3 Filler Order Number 
Filler order number, used as the item 
name. 
4# Universal Service ID 
Universal service ID, taking manufacture 
name^device model. 
5 Priority Leave empty and reserved. Priority 
6 Requested Date/time Leave empty and reserved. Request time 
 
No. Field Description 
7 Observation Date/time 
Observation time and date, used as quality 
control date. 
8 Observation End Date/Time 
Leave empty and reserved. Date of 
observation end. 
9 Collection Volume Quality control rule, no data yet. 
10Collector Identifier Sample type 
11 Specimen Action Code Quantity of controls 
12 Danger Code Control code 
13 Relevant Clinical Info Control name 
14 Specimen Received Date/Time Control batch No. 
15 Specimen Source Control valid date 
16 Ordering Provider Item result unit 
17 Order Callback Phone Number Out-of-control tag 
18 Placer Field 1 Control mean value (mean concentration) 
19 Placer Field 2 Control standard deviation 
20 Filler Field 1 Test result value (concentration value) 
21 Filler Field 2 Reminder 
22 
Result Rpt/Status Change-
Date/Time 
Leave empty and reserved. Result report 
date / time. 
23 Charge to Practice 
Leave empty and reserved. Charge to 
practice 
24 Diagnostic Serv Sect ID 
Leave empty and reserved. Diagnostic 
section 
 
No. Field Description 
25 Result Status Leave empty and reserved. Result status 
26 Parent Result 
Leave empty and reserved. Parent order 
result 
27 Quantity/Timing Leave empty and reserved. Quantity / time 
28 Result Copies To 
Leave empty and reserved. Result copies 
to. 
29 Parent Leave empty and reserved. Parent order 
30 Transportation Mode 
Leave empty and reserved. Transportation 
mode 
31 Reason for Study 
Leave empty and reserved. Reason for 
study 
32 Principal Result Interpreter 
Principal result interpreter, used as the 
reviewer. 
33 Assistant Result Interpreter 
Leave empty and reserved. Assistant result 
interpreter 
34 Technician Leave empty and reserved. Technician 
35 Transcriptionist Leave empty and reserved. Transcription 
36 Scheduled Date/Time 
Leave empty and reserved. Scheduled 
date 
37 Number of Sample Containers 
Leave empty and reserved. Quantity of 
sample containers 
38 
Transport Logistics of 
Collected Sample 
Leave empty and reserved. Transportation 
logistics of collected samples 
39 Collector’s Comment 
Leave empty and reserved. Collector’s 
comment 
40 Transport Arrangement Leave empty and reserved. Transportation 
 
No. Field Description 
Responsibility arrangement responsibility 
41 Transport Arranged 
Leave empty and reserved. Whether to 
arrange transportation 
42 Escort Required 
Leave empty and reserved. Escort is 
required. 
43 
Planned Patient Transport 
Comment 
Leave empty and reserved. Transportation 
comment for planned patient. 
44 Procedure Code 
Leave empty and reserved. Procedure 
code 
45 Procedure Code Modifier 
Leave empty and reserved. Procedure 
code modifier 
46 
Placer Supplemental Service 
Information 
Leave empty and reserved. Supplemental 
service information 
47 
Filler Supplemental Service 
Information 
Leave empty and reserved. Fill the 
supplemental service information. 
48 
Medically Necessary Duplicate 
Procedure Reason. 
Leave empty and reserved. Medically 
necessary duplicate procedure reason. 
49 Result Handling 
Leave empty and reserved. Result 
handling 
According to the quantity of controls, the content of the 12th, the 13th, the 14th, the 17th, 
the 18th, the 19th, and the 20th fields is in the format of V1^V2^ … Vi. It should be noted 
that for day-to-day control, each quality control test constitutes a message to be sent, while 
for real-time quality control and daily control, multiple tests of each item together constitute 
a message to be sent, with the quality control tests of different batches sent separately. 
Example: 
QC result message field, refer to Section 3.5.3 QC Results of LIS Protocol. 
Field meaning Value 
Item No. 
1 
 
Item name 
ALT 
Sample type 
Serum 
Number of controls 
1 
Control code 
2 
Control name 
qcc 
Control batch No. 
201106 
Control mean value 2 
Control standard deviation 0.5 
QC result 1.5 
The software sends the following ORU^R01 message to the LIS. 
OBR|1|1| ALT 
|Zybio^EXC200|||20201106104516|||Serum|1|2|qcc|201106||g/L||2|0.5|1.5|||||||||||||||||||||||||||
|| 
4.5.4 QC summary 
When transmitting the QC data result (take 3 as MSH-16), the field is defined as follows: 
No. Field Description 
1 Set ID –OBR Defines the fields of different OBR. 
2 Placer Order Number Placer order number, used as the item 
number. 
3 Filler Order Number Filler order number, used as the item 
name. 
4# Universal Service ID Universal service ID, taking manufacture 
name^device model. 
5 Priority Leave empty and reserved. Priority 
6 Requested Date/time Leave empty and reserved. Request time 
7 Observation Date/time Leave empty and reserved. Observation 
time and date 
8 Observation End Date/Time Leave empty and reserved. Date of 
 
No. Field Description 
observation end. 
9 Collection Volume Leave empty and reserved. 
10 Collector Identifier Sample type 
11 Specimen Action Code Item result unit 
12 Danger Code Leave empty and reserved. 
13 Relevant Clinical Info Control name 
14 Specimen Received Date/Time Control batch No. 
15 Specimen Source Mean value 
16 Ordering Provider Standard deviation 
17 Order Callback Phone Number Summary of mean value 
18 Placer Field 1 Summary of standard deviation 
19 Placer Field 2 Summary of CV 
20 Filler Field 1 Summary of N 
21 Filler Field 2 Leave empty and reserved. 
22 Result Rpt/Status Change-
Date/Time 
Leave empty and reserved. Result report 
date / time. 
23 Charge to Practice Leave empty and reserved. Charge to 
practice 
24 Diagnostic Serv Sect ID Leave empty and reserved. Diagnostic 
section 
25 Result Status Leave empty and reserved. Result status 
26 Parent Result Leave empty and reserved. Parent order 
result 
27 Quantity/Timing Leave empty and reserved. Quantity / time 
28 Result Copies To Leave empty and reserved. Result copies 
to. 
29 Parent Leave empty and reserved. Parent order 
30 Transportation Mode Leave empty and reserved. Transportation 
mode 
31 Reason for Study Leave empty and reserved. Reason for 
study 
32 Principal Result Interpreter Principal result interpreter, used as the 
reviewer. 
 
No. Field Description 
33 Assistant Result Interpreter Leave empty and reserved. Assistant result 
interpreter 
34 Technician Leave empty and reserved. Technician 
35 Transcriptionist Leave empty and reserved. Transcription 
36 Scheduled Date/Time Leave empty and reserved. Scheduled 
date 
37 Number of Sample Containers Leave empty and reserved. Quantity of 
sample containers 
38 Transport Logistics of 
Collected Sample 
Leave empty and reserved. Transportation 
logistics of collected samples 
39 Collector’s Comment Leave empty and reserved. Collector’s 
comment 
40 Transport Arrangement 
Responsibility 
Leave empty and reserved. Transportation 
arrangement responsibility 
41 Transport Arranged Leave empty and reserved. Whether to 
arrange transportation 
42 Escort Required Leave empty and reserved. Escort is 
required. 
43 Planned Patient Transport 
Comment 
Leave empty and reserved. Transportation 
comment for planned patient. 
44 Procedure Code Leave empty and reserved. Procedure 
code 
45 Procedure Code Modifier Leave empty and reserved. Procedure 
code modifier 
46 Placer Supplemental Service 
Information 
Leave empty and reserved. Supplemental 
service information 
47 Filler Supplemental Service 
Information 
Leave empty and reserved. Fill the 
supplemental service information. 
48 Medically Necessary Duplicate 
Procedure Reason. 
Leave empty and reserved. Medically 
necessary duplicate procedure reason. 
49 Result Handling Leave empty and reserved. Result 
handling 
4.6 OBX - observation 
OBX is used mainly to transmit the observation information in the report message. When 
transmitting the sample test information of a patient (take 0 as MSH-16), there may be 
 
multiple OBXs of one patient. This interface doses not provide repeatability test for test 
data, and the LIS of user shall process the data. 
No. Field Description 
1 Set ID – OBR Defines the fields of different OBXs. 
2 Value Type Value type, taken as NM. 
3# Observation Identifier Observation identifier, used as item 
numberand item name. The item 
number and item name are separated 
by ^, such as: 1^CRP. 
4 Observation Sub-ID Leave empty and reserved. Observation 
Sub-ID 
5 Observation Value Observation value, used as test result 
value (result concentration, negative, 
positive, etc.) 
6 Units Unit, the measuring unit of test result 
value. 
7 References Range Reference range, the normal range of 
test result value. 
8 Abnormal Flags Leave empty and reserved. Abnormal 
flag, describing whether the test result is 
normal. L - Low, H - High, N - Normal. 
9 Probability Probability Used as a result tag, linked 
with ^. It includes: 1. LRL (above the 
upper limit of linear range), 2. LRG 
(below the lower limit of linear range), 3. 
↑! (above the upper limit of critical 
value), 4. ↓! (below the lower limit of 
danger value), 5. ↑ (above the upper 
limit of reference range), 6. ↓ (below 
the lower limit of reference range). 
10 Nature of Abnormal Test Leave empty and reserved. Reason of 
abnormal test, used as qualitative 
 
No. Field Description 
reference value. 
11# Observe Result Status Leave empty and reserved. Observation 
result status, taking F-final results. 
12 Date Last Observe Normal 
Values 
Leave empty and reserved. Date of the 
last normal observation values. 
13 User Defined Access Checks User-defined access test, used as 
original result. 
14 Date/Time of the Observation Leave empty and reserved. Observation 
time and date 
15 Producer's ID Result producer’s ID 
16 Responsible Observer Responsible observer, used as 
examination physician. 
17 Observation Method Leave empty and reserved. Observation 
method 
18 Equipment_Instance_Identifi
er 
Leave empty and reserved. Equipment 
instance identifier 
19 Date_Time_of_the_Analysis Observation time and date, used as test 
time. 
Example: 
Field meaning Value 
Item No. 19 
Item name ALT 
Test result value 35.85 
Unit U/L 
Reference range 5.00-40.00 
 
The software sends the following OBX message segment to the LIS. 
OBX|0|NM|19^ALT||35.85|U/L|5.00-40.00||||||||||||20201130090608 
4.7 QRD - query definition segment 
No. Field Description 
1# Query Date/Time The generation time of current query, taking 
the system time. 
2# Query Format Code Query format code, query method. N 
denotes the LIS serial code, R denotes the 
sample bar code, T denotes the time period. 
3# Query Priority Query priority, taking D (deferred). 
4# Query ID Query ID, representing different queries. It 
increases incrementally along with the 
number of queries. 
5 Deferred Response Type Leave empty and reserved. Deferred 
response type 
6 Deferred Response Date/Time Leave empty and reserved. Deferred 
response date 
7# Quantity Limited Request Quantity limit request, taking RD (Records). 
8# Who Subject Filter Inquirer filter identifier, used as sample bar 
code. 
9# What Subject Filter Leave empty and reserved. Query content 
filter identifier 
10# What Department Data Code Leave empty and reserved. Partial data 
code 
11 What Data Code Value Qual Leave empty and reserved. Data code value 
limit 
12 Query Results Level Leave empty and reserved. Query results 
level, taking T (full results). 
 
4.8 QRF - query filter segment 
QRF segment is used together with QRD to further simplify the original query content. 
No. Field Description 
1# Where Subject Filter Inquirer address filter identifier, taking device 
model. 
2 When Data Start Date/Time Record start date and time, used as the start 
time of sample acceptance at query. 
3 When Data End Date/Time Record end date and time, used as the end 
time of sample acceptance at query. 
4 What User Qualifier Leave empty and reserved. User qualifier 
5 Other QRY Subject Filter Leave empty and reserved. Other. QRF 
acceptance filter 
6 Which Date/Time Qualifier Target type, taking RCT. 
7 Which Date/Time Status 
Qualifier 
Target status, taking COR. 
8 Date/Time Selection 
Qualifier 
Date/time selection qualifier, taking ALL. 
9 When Quantity/Timing 
Qualifier 
Leave empty and reserved. Time interval 
segment 
4.9 ERR - error segment 
ERR segment adds the error description in the acknowledgment message. 
No. Field Description 
1# Error Code and Location Error code and location 
2 Error Location Leave empty and reserved. Error location 
3 HL7 Error Code Leave empty and reserved. HL7 error code 
 
No. Field Description 
4 Severity Leave empty and reserved. Severity 
5 Application Error Code Leave empty and reserved. 
6 Application Error Parameter Leave empty and reserved. Application error 
parameter 
7 Diagnostic Information Leave empty and reserved. Diagnostic 
information 
8 User Message Leave empty and reserved. User information 
9 Inform Person Indicator Leave empty and reserved. Inform person 
indicator 
10 Override Type Leave empty and reserved. Override type 
11 Override Reason Code Leave empty and reserved. Override reason 
code 
12 Help Desk Contact Point Leave empty and reserved. Help desk contact 
point 
4.10 QAK - query acknowledgment segment 
QAK segment contains query response messages. 
No. Field Description 
1# Query Tag Query tag, taking SR. 
2 Query Response Status Query response status 
OK: Data found, no errors 
NF: No data found, no errors 
AE: Application error 
AR: Application reject 
3 Message Query Name Leave empty and reserved. Message query 
name 
 
No. Field Description 
4 Hit Count Leave empty and reserved. Hit count 
5 This payload Leave empty and reserved. Current 
payload 
6 Hits remaining Leave empty and reserved. Counts of 
mishit 
4.11 DSP - display data segment 
DSP segment is used to display the queried sample application information and patient 
information. It can be repeated. 
No. Field Description 
1 Set ID-DSP Defines different DSP segment. 
2 Display Level Display level 
3# Data Line Data line, the queried content. 
4 Logical Break Point Logical break point 
5 Result ID Result ID 
The 3rd field of “Data Line” is used to display the sample application information 
downloaded from the LIS server. Refer to the table below for the detailed sample 
application information entries and sequence, wherein bar code and item number are 
indispensable, and other information can be empty. When the sample involves more than 
1 items, fields are added at from the 29th field, in the same format with the 29th field. 
Sequence Content Remarks 
1 Admission Number Admission number 
2 Bed Number Bed No. 
3 Patient Name Patient name 
4 Date of Birth Age and age unit. The age and age 
unit (Year - Y, Month - M, Week - W, 
 
Sequence Content Remarks 
Day - D, Hour - H) are separated 
with ^. 
5 Sex M stands for male, F stands for 
Female, O stands for Others, and U 
stands for Unknown. 
6 Patient Alias Blood types, including A, B, AB, O, 
and U (U denotes other blood types). 
7 Race Special blood type: RhD(+),RhD(-) 
8 Patient Address Examination physician 
9 County code Reviewer 
10 Home Phone Number Patient ID 
11 Business Phone Number Sample position, comprising sample 
disk number ^cuvette number (not 
enabled yet). 
12 Primary Language Sampling time 
13 Marital Status 
14 Religion 
15 Patient Account Number Clinical diagnosis 
16 Social security number Remarks 
17 Driver License Number Examination physician 
18 Ethnic Group 
19 Birth Place 
20 Nationality 
21 Bar code Sample bar code 
 
Sequence Content Remarks 
22 Sample ID Serial code 
23 Sample Time Submission date 
24 Emergency or not. Y stands for 
Yes, and N stands for No. N is 
the default selection. 
 
25 Collection volume Manual dilution factor 
26 Sample type Serum - SERUM, plasma - PLASMA, 
urine - URINE, whole blood – 
WH_Blood, pleural and peritoneal 
fluids – PPF, cerebrospinal fluid - 
CSF, other - OTHER. 
27 Fetch Doctor Submitter 
28 Fetch department Fetch department. 
29 Test ID^Test Name^Unit^Normal 
Range 
The ID of theitem parsed by 
instrument (channel number), the 
item parameters are subject 
instrument parameters. 
4.12 DSC - continuation pointer segment 
DSC segment is used to indicate whether the response message is the last data message. 
No. Field Description 
1 Continuation pointer Continuation pointer 
Note: this message segment is used only in DSR^Q03 message for response. For mass 
query, the value of the unique field of the segment in the last sample application information 
DSR message is null (as an identifier of the completion of data transmission), and the 
unique field of the segment in other DSR messages is not null. 
5 Summary of examples 
Sample test result 
 
Field meaning Value 
Patient ID 1111 
Patient name ZHANG San 
Age 60 
Sex Male 
Blood type A 
Sample bar code 123456 
Serial code 1 
Sample type Serum 
Sample position Disk No.1, cuvette No.2 
Item number 19 
Item name ALT 
Test result value 35.85 
Unit U/L 
Reference range 5.00-40.00 
<SB>MSH|^~\&|Zybio|EXC200|||20210105104254||ORU^R01|650|P|2.5||||0||UNICODE|||
<CR> 
PID|1||1111||ZHANG San||60^Y|M|A||||||||||||||||||||||||||||||<CR> 
OBR|1|123456|1|Zybio^EXC200||20201130090600|20201130090608|||1^1||||2020113008
0000|SERUM||||Engineer||||||||||||||||||||||||||||||<CR> 
OBX|0|NM|19^ALT||35.85|U/L|5.00-40.00|N|||||||||||20201130090608<CR> 
<EB><CR> 
QC result 
Field meaning Value 
Item No. 1 
 
Item name ALT 
Sample type Serum 
Number of controls 1 
Control code 2 
Control name qcc 
Control batch No. 201106 
Control mean value 2 
Control standard deviation 0.5 
QC result 1.5 
<SB>MSH|^~\&|Zybio|EXC200|||20201106104535||ORU^R01|13|P|2.5||||2||UNICODE|||<
CR> 
OBR|1|1| ALT 
|Zybio^EXC200|||20201106104516|||serum|1|2|qcc|201106||g/L||2|0.5|1.5||||||||||||||||||||||||||||
|<CR> 
<EB><CR>

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