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0027A
机密等级 秘密 版 本 AB
项目代码 ALL 页 码 共 39 页
项目名称:
血液细胞分析仪
文件名称:
血液细胞分析仪 LIS 通信协议说明书(英文)
适用范围:
所有血液细胞分析仪
相 关 文 档
文件编号 文件名称 版本
磁盘文件名称 字节数 复核 日期
模板编号及版本: DMR-MB-007[1.6]
修 订 记 录
DMR 文件重新排版后归档。
2018.11.05(张勇):
项目代码改为“ALL”。
AB PECR2021077 王怡岚 2022-04-14
添加支持 1116 系列产品协议内容。(B.2 表
格和 OBX 消息数据项自定义取值中的测量模
式)
优化排版。
适用范围改为“所有血液细胞分析仪”。
知识产权属帝迈公司所有 第 2 页 共 39 页
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Auto Hematology Analyzer
Instructions for LIS Communication
Protocol
Auto Hematology Analyzer Instructions for LIS Communication Protocol
1
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Sub Component
PID|1||05012006^^^^MR||^Zhang San||19991001000000|Male
PV1|1|Inpatient|Internal medicine^1^2|||||||||||||||||Self-paid
OBX|2|IS|02002^Blood Mode^99MRC||W||||||F
OBX|3|IS|02003^Test Mode^99MRC||CBC+DIFF||||||F
OBX|4|NM|30525-0^Age^LN|||yr|||||F
OBX|5|IS|09001^Remark^99MRC||||||||F
OBX|6|IS|03001^Ref Group^99MRC||General||||||F
OBX|7|NM|6690-2^WBC^LN||5.51|10*9/L|4.00-10.00||||F
OBX|8|NM|770-8^NEU%^LN||66.1|%|50.0-70.0||||F
OBX|9|NM|736-9^LYM%^LN||28.1|%|20.0-40.0||||F
OBX|10|NM|5905-5^MON%^LN||4.4|%|3.0-12.0||||F
OBX|11|NM|713-8^EOS%^LN||1.2|%|0.5-5.0||||F
OBX|12|NM|706-2^BAS%^LN||0.2|%|0.0-1.0||||F
... ...
2
Auto Hematology Analyzer Instructions for LIS Communication Protocol
2 Introduction to HL7
2.1 HL7 Basic Grammar
2.1.1 Message Composition Rule
An HL7 message consists of segments and each segment ends with <CR>.
A segment consists of a 3-character segment name and a variable number of fields. A field consists of
components and sub-components. Separators of fields, components, and sub-components are defined at
the message header (MSH) of each message.
For example:
MSH|^~\&|DH56|Dymind|||20140927104252||ORU^R01|d51b54aca4064d20be8084f00850585f|P|2.3.1||||||UNICODE
The five characters following the MSH are used to define the separators for distinguishing fields, com-
ponents, and sub-components. These characters can be any non-text characters. The characters listed in
the following table are recommended in the HL7 standard.
Character Description
| Separator of fields
^ Separator of components
& Separator of sub-components
~ Separator of duplicate items
\ Escape character
The first field of the MSH contains the separators. Some fields behind the MSH are blank because they
are optional and are not used in Dymind HL7 interfaces. The detailed definition and selecting of fields are
described in the following sections.
For any type of message, the segments behind the MSH are arranged in a certain sequence. The sub-
sequent sections describe the sequences based on the following syntax structure:
Segments in [] are optional.
Segments in {} can be duplicated for once or more times.
3
Auto Hematology Analyzer Instructions for LIS Communication Protocol
The following table lists the rules for transferring character strings used in HL7 interfaces.
Escape Character Sequence Original Character
\F\ Separator of fields
\S\ Separator of components
\T\ Separator of sub-components
\R\ Separator of duplicate items
\E\ Escape separator
\.br\ <CR>, end of segment
Note: In an escape character sequence, the slash (\) indicates an escape separator and its value is de-
fined in the MSH.
3 Duplex Separation
3.1 Supported HL7 Messages
3.1.1 Duplex Separation Process
1. The host sends the test results or QC data to the LIS directly. See Figure 3-1.
Figure 3-1 Communication process of test results or QC data
ORU
ACK
PC LIS
In the preceding figure, the ORU event indicates that the PC connecting to the host actively sends the
test results to the LIS. Both the test results and QC data can be queried by sending worklist infor-
mation in this way.
2. Worklist information (Order information) can be queried by sending the following HL7 messages:
General Order Message (ORM) and General Order Response Message (ORR). The communication
process is as shown in Figure 3-2.
Figure 3-2 Communication process of worklist information query
ORM
ORR
PC LIS
MSH: message header, which is mandatory and carries the message ID, sending time, message separator, and encoding
format
4
Auto Hematology Analyzer Instructions for LIS Communication Protocol
PID: basic patient information, including the patient name, gender, medical record number, and date of birth
[PV1]: medical information, including the patient type, department, bed number, and payment type
OBR: sample information, including the sample ID, tester, and test time
{[OBX]}: test data items, including the test parameter results and work mode
}
ACK^R01 message
This message is used to acknowledge the received ORU^R01 message.
ACK Acknowledgment Description
MSA: message acknowledgement, indicating whether the communication message is received successfully
ORM^ O01 message
General order message. All actions related to the order will use the message type, such as creating
an order or canceling an order. In this example, the host requests the LIS to refill the order message.
ORM General Order Message Description
{PID}: patient information, including the medical record No. of the queried sample
ORR^O02 message
This message is the acknowledgement message of ORR^O01 and carries complete information
about the work order.
ORR^O02 General Order Response Message Description
{[OBX]}: other sample information items, including the work mode of the sample
5
Auto Hematology Analyzer Instructions for LIS Communication Protocol
3.2.1 MSH
The MSH (Message Header) segment contains the basic information of HL7 message, including the value
of the message separator, message type, and encoding format. The MSH is the first field of every HL7
message.
Example:
MSH|^~\&|DH56|Dymind|||20140927104252||ORU^R01|d51b54aca4064d20be8084f00850585f|P|2.3.1||||||UNICODE
6
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Recommended
Data
SN Field Name Maximum Description Example
Type
Length
Message creation time, in the for-
Date/Time Of mat of 20140927104
7 TS 26
Message YYYY[MM[DD[HH[MM[SS]]]]]. Its 252
value is the system time.
Message Message type, in the format of
9 CM 7 ORU^R01
Type Message type^Event type.
Message Message control ID, used to
10 ST 20 1
Control ID uniquely identify a message.
Message processing ID. Itsvalue
includes:
P: the sample and worklist queried
P
11 Processing ID PT 3 information.
Q: the QC counting result. In the
ACK message, it is consistent with
the message received before.
HL7 version number. Its value is
12 Version ID VID 60 2.3.1
2.3.1.
Character set. Its value is
UNICODE, and communication
18 Character Set ID 10 UNICODE
messages are represented by
UTF-8 encoded characters.
3.2.2 MSA
The message acknowledgement (MSA) segment contains message acknowledgement information.
Example:
MSA|AA|0
Table 3-2 defines the fields used in the MSA segment.
Table 3-2 Definitions of MSA fields
Recommended
Data
SN Field Name Maximum Description Example
Type
Length
Message acknowledgement
Acknowl- code, including:
1 edgement ID 2 AA: message received AA
Code AE: error
AR: message refused
Message control ID, which is
Message
2 ST 20 the same as theMSH-10 of the 0
Control ID
received message.
Error condition (status code).
The message can be trans-
Error Condi- mitted, or the error condition
6 CE 100
tion description can be carried. For
details about the error codes,
see Table 3.
Table 3-3 Error codes of the MSA-6 field
Status Code
Status Text (MSA-3) Description
(MSA-6)
Successful status code: AA
0 Message accepted Succeed
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Auto Hematology Analyzer Instructions for LIS Communication Protocol
Status Code
Status Text (MSA-3) Description
(MSA-6)
Error status code: AE
The sequence of segments in the message is
100 Segment sequence error
wrong, or the mandatory segment is missing.
101 Required field missing The mandatory field of a segment is missing.
The data type of the field is wrong. For ex-
102 Data type error ample, the data type is set to character for
digits.
103 Table value not found The table value is not found.
Rejection status code: AR
200 Unsupported message type The message type is not supported.
201 Unsupported event code The event code is not supported.
202 Unsupported processing id The processing ID is not supported.
203 Unsupported version id The version ID is not supported.
An unknown key identifier is found. For ex-
204 Unknown key identifier ample, transmitting the information about a
patient that does not exist.
The key identifier is repeated with an existing
205 Duplicate key identifier
one.
A transaction cannot be executed in the
206 Application record locked storage level of the application. For example,
the database is locked.
207 Application internal error An unknown internal application error occurs.
3.2.3 PID
The patient identification (PID) segment contains basic patient information.
Example:
PID|1||05012006^^^^MR||^Zhang San||19991001000000|Male
8
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Recommended
Field Data
SN Maximum Description Example
Name Type
Length
Gender of the patient. Its val-
8 Sex IS 1 Male
ue is a character string.
3.2.4 PV1
The patient visit (PV1) segment contains medical information of the patient.
Example:
PV1|1|Inpatient|Surgical^1^2|||||||||||||||||Self-paid
3.2.5 OBR
The observation request (OBR) segment contains the information of the test report.
Example:
OBR|1||5|00001^Automated Count^99MRC||20140918091000|20140918105930|||Dr.
Wang||||20140918103000||||||||||HM||||||||develop
9
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Recommended
SN Field Name Data Type Description Example
Maximum Length
Universal service ID, used
to identify the counting 00001^Auto
Universal result type. For details mate d
4 CE 200
Service ID about the values, see Ap- Count^99M
pendix B Message RC
Codes.
Request time. It is used to
Requested 201409180
6 TS 26 represent the sampling
Date/time 91000
time.
Observation 201409181
7 TS 26 Test time.
Date/Time # 05930
Sample collector. In this
example, it is used to rep-
Collector
10 XC N 60 resent the person that Dr. Wang
Identifier *
takes the sample for test-
ing.
Clinical information. It can
be used to represent the
Relevant
13 ST 300 clinical diagnosis infor-
Clinical Info.
mation in the patient in-
formation.
Sample receiving time. It is
Specimen
used to represent the time 201409181
14 Received TS 26
when the sample is sub- 03000
Date/Time *
mitted for testing.
Sample source. In an HL7
message, its value is
Specimen BLDV, which indicates ve-
15 CM 300
Source * nous blood, or BLDCO,
which indicates umbilical
cordblood.
Results
Result report or status
Rpt/Status
change time. It is used to
22 Change TS 26
represent the validation-
-Date/Time
time.
+
Diagnostic section ID. The
Diagnostic
24 ID 10 value is HM, which indi- HM
Serv Sect ID
cates hematology.
Recipient of result copies.
Result
28 XC N 60 It represents the sample
Copies To
validator.
Principal result interpreter.
Principal It is used to represent the
32 Result In- CM 200 tester in a sample mes- develop
terpreter + sage, or the operator in a
QC counting message.
3.2.6 OBX
The observation/result (OBX) segment contains the test result parameters.
Example:
OBX|7|NM|6690-2^WBC^LN||5.51|10*9/L|4.00-10.00||||F
10
Auto Hematology Analyzer Instructions for LIS Communication Protocol
11
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Recommended
Data
SN Field Name Maximum Description Example
Type
Length
is lower than the lower refer-
ence limit.
Note: The abnormal flag and
high or low alarm flag may
exist concurrently. Multiple
flags are separated with ~, for
example, H~A.
Observe
Test result status. The value F
11 Result Sta- ID 1 F
indicates the final result.
tus
3.2.7 ORC
The common order (ORC) segment contains general order information.
Example:
ORC|RF||SampleID||IP
12
Auto Hematology Analyzer Instructions for LIS Communication Protocol
13
Auto Hematology Analyzer Instructions for LIS Communication Protocol
OBR|2||5|00002^Manual Count^99MRC
Sample response message
A sample response message must be returned when a sample result is received. A sample response
message contains two segments: MSH and MSA. In a correct response message, the MSH-9 field is
set to ACK^R01, indicating that the type of this message is sample response message. The value of
the MSA-2 field is the same as that of the MSH-10 field in the received counting result, indicating the
counting result that the response message matches. In this example, the value of MSA-2 is 1.
MSH|^~\&|DH56|Dymind|||20140927104252||ACK^R01|d51b54aca4064d20be8084f00850585f |P|2.3.1||||||UNICODE
MSA|AA|1
MSA|AA|1
14
Auto Hematology Analyzer Instructions for LIS Communication Protocol
response message. If the query is successful, the response message will contain the PID, PV1, ORC,
OBR and OBX segments, which describe the patient and sample information. The information de-
scription method is the same as that in sample data communication messages. In a successful query
message, the ORC segment is mandatory. The value of ORC-1 is AF, and the value of ORC-2 is the
sample ID. OBR-2 specifies the sample ID. The device will not verify whether the received sample ID
is consistent with the medical number.
MSA-2 specifies the response result. In this example, its value is AR, indicating that the query re-
quest is rejected. Its value can also be AE, indicating that an error occurs in processing the query
request
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Auto Hematology Analyzer Instructions for LIS Communication Protocol
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Auto Hematology Analyzer Instructions for LIS Communication Protocol
17
Auto Hematology Analyzer Instructions for LIS Communication Protocol
18
Auto Hematology Analyzer Instructions for LIS Communication Protocol
19
Auto Hematology Analyzer Instructions for LIS Communication Protocol
20
Auto Hematology Analyzer Instructions for LIS Communication Protocol
11025^WBC-N(TBD)^99MR
WBC-N(TBD) NM 11025 WBC-N(TBD) 99MRC
C
21
Auto Hematology Analyzer Instructions for LIS Communication Protocol
22
Auto Hematology Analyzer Instructions for LIS Communication Protocol
23
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Erythrocyte
sedimentation NM 30341-2 ESR LN 30341-2^ESR^LN
rate (ESR)
Abnormal 29261-5^Abnormal
Atypical lympho-
NM 29261-5 Lymphs%. Man- LN Lymphs%. Manual^LN
cyte
ual
24
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Intermediate Data of Test Results (WBC, RBC and PLT Histogram and Scattergram Data)
Left line of WBC NM 12001 WBC Histogram. 99MRC 12001^WBC Histogram. Left
histogram Left Line Line^99MRC
25
Auto Hematology Analyzer Instructions for LIS Communication Protocol
26
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Alarm Information
13101^Leucocytosis^99MR
Leucocytosis IS 13101 Leucocytosis 99MRC
C
13105^Lymphocytosis^99M
Lymphocytosis IS 13105 Lymphocytosis 99MRC
RC
13106^Lymphopenia^99MR
Lymphopenia IS 13106 Lymphopenia 99MRC
C
17790-7^WBC Left
WBC left shift? IS 17790-7 WBC Left Shift? LN
Shift?^LN
Atypical 15192-8^Atypical
Atypical lymphs? IS 15192-8 LN
Lymphs? Lymphs?^LN
27
Auto Hematology Analyzer Instructions for LIS Communication Protocol
13002^WBC Abnor-
WBC abnormal IS 13002 WBC Abnormal 99MRC
mal^99MRC
13301^Erythrocy to-
Erythrocytosis IS 13301 Erythrocytosis 99MRC
sis^99MRC
RBC dual pop IS 10379-6 RBC Dual Pop LN 10379-6^RBC Dual Pop^LN
13202^RBC
RBC clump? IS 13202 RBC Clump? 99MRC
Clump?^99MRC
13203^Iron Deficien-
Iron deficiency? IS 13203 Iron Deficiency? 99MRC
cy?^99MRC
13204^HGB Inter-
HGB Interfere IS 13204 HGB Interfere 99MRC
fere^99MRC
13501^Thrombocytosis^99
Thrombocytosis IS 13501 Thrombocytosis 99MRC
MRC
13502^Thrombopenia^99M
Thrombopenia IS 13502 Thrombopenia 99MRC
RC
28
Auto Hematology Analyzer Instructions for LIS Communication Protocol
13701^CRP In-
CRP increased IS 13701 CRP Increased 99MRC
creased^99MRC
13704^ RF In-
RF increased IS 13704 RF Increased 99MRC
creased^99MRC
13705^ TRF In-
TRF increased IS 13705 TRF Increased 99MRC
creased^99MRC
13706^ SAA In-
SAA increased IS 13706 SAA Increased 99MRC
creased^99MRC
29
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Part of the OBX message data uses user-defined enumerated values. The following table describes
the values of different data items.
Data Item Enumerated Value
O: open
Take Mode A: automatic
C: closed
W: whole blood
Blood Mode P: pre-diluted blood
C: capillary blood
CBC
CBC+DIFF
RET
CBC+RET
CBC+DIFF+RET
SAA
CRP
Test Mode
CBC+CRP
CRP+SAA
CBC+DIFF+SAA
CBC+DIFF+CRP
CBC+DIFF+SAA+CRP
X
CBC+X
The format is AB blood type RH blood type.
Blood Type The values of AB blood type include A, B, AB, and O, and those
of RH blood type include RH+ and RH-.
L: low
QC Level M: medium
H: high
The data type of OBX-2 is IS. Its value can be either of the fol-
Histogram line adjustment flag lowing enumerated values:
and alarm flag T: true
F: false
Histogram data transmission include the following situations according to software settings:
Do not transmit histogram data.
Transmit the histogram data in the form of bitmap. In the OBX segment, the value of the data
type field is ED. The value of the data field is in the format of ^Image^BMP^Base64^…bitmap of
histogram data, in which,Image indicates that an image is transmitted; BMP is a user-defined
sub-data type, indicating that a bitmap of the BMP type is transmitted. Currently supported image
formats include BMP and PNG.
Base64 indicates the encoding format of bitmap data.
The printed bitmap and displayed bitmap are differentiated.
For scattergram data, the value of the data type field in the OBX segment of the bitmap data is
ED. The value of the data field is in the format of ^Image^BMP^Base64^…bitmap of scattergram
data, in which, Image^BMP^Base64 indicates transmitting BMP bitmap data that is encoded in
Base64 format.
30
Auto Hematology Analyzer Instructions for LIS Communication Protocol
31
Auto Hematology Analyzer Instructions for LIS Communication Protocol
The six bits can be combined in 64 ways. That is, Base64 encoding requires at least 64 characters. A
special character = will be introduced later. Base64 encoding uses characters from A to Z, a to z, 0 to
9, +, and / (that is, [A-Za-z0-9+/]).
Assume that there is a 3-byte data, byte[] {1, 2, 3}, which is as follows in binary format:
00000001 | 00000010 | 00000011
The data record is as follows after being encoded in Base64 encoding format:
000000 | 010000 | 001000 | 000011
The data record is 0 | 16 | 8 | 3 in decimal format, and is AQID in text format after encoding.
32
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Base64 encoding convert every three bytes into four characters. What if the number of bytes of an
image cannot be exactly divided by 3?
In Base64 encoding, if there is one remaining byte after division, this byte will also be converted into
four characters. The first 6-bit of this byte will be converted into a character, the other 2-bitwill be
converted into a character (zeros will be added on the right), and two equal signs (=) are added at the
end.
Assume that there is a 4-byte, byte[] {1, 2, 3, 4}-, which is as follows in binary format:
00000001 | 00000010 | 00000011 | 00000100
The data record is as follows after being encoded in Base64 encoding format:
000000 | 010000 | 001000 | 000011 | 000001 | 000000
The data record is 0 | 16 | 8 | 3 | 1 | 0 in decimal format, and is AQIDBA== in text format after en-
coding.
After being divided by 3, two bytes are left. The encoding mode is similar to that for a single byte.
Each byte will be converted into four characters, and an equal sign (=) will be added at the end.
Assume that there is a 5-byte data, byte[] {1, 2, 3, 4, 5}, which is as follows in binary format:
00000001 | 00000010 | 00000011 | 00000100 | 00000101
The data is as follows after being encoded in Base64 encoding format:
000000 | 010000 | 001000 | 000011 | 000001 | 000000 | 010100
The data record is 0 | 16 | 8 | 3 | 1 | 0 | 20 in decimal format, and is AQIDBAU= in text format after
encoding.
33
Auto Hematology Analyzer Instructions for LIS Communication Protocol
Base64 encoding is also used to simply encrypt some data. The actual encryption process is usually
complex.
Spam spreaders will use Base64 encoding to prevent spam from being blocked by anti-spam tools
because these tools will not translate information encoded in Base64 format.
In LDIF archives, Base64 is used to encode characters strings.
34
P/N: 65.05.0027A[AB]