NOTICE: This standard has either been superseded and replaced by a new version or discontinued, Contact ASTM International (www.astm.org) for the latest information. Aly Designation: E 1361-95 ul Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems* ‘This sand sued ues fe design & 1381; he eae immediately Flowing the eign inne th ys gia lepine, in ae of ein te yer of lat ein. Auer in penser nse yet It eps A ‘sprenp pion nice ional chang ance nt ein rape. 1. Seope 1.1 This specification describes the electronic. transmission of digital information between clinical laboratory instruments and computer systems. The clinical laboratory instruments under consideration are those that measure one or more parameters from one or more patient samples. Often they will ‘be automated instruments that measure many parameters from many patient samples. The computer systems considered here are those that are configured to accept instrument results for further processing, storage, reporting, or manipulation. This instrument output may include patient results, quality control results, and other related information. Typically, the computer ‘em will be a Laboratory Information Management System IMS) 1.2 The terminology of the Organization for Intemational Standards (ISO) Reference Mode! for Open Systems Intereon- rection (OSI) is generally followed in describing the commu- nications protocol and services. The electrical and mechanical connection between instrument and computer is described in the Physical Layer section, The methods for establishing communication, error detection, error recovery, and sending and receiving of messages are described in the Data Link Layer section, The data link layer interacts with higher layers in terms of sends and receives “messages,” handles data link connection and release requests, and reports the data link status 1.3 Specification E 1394 is concemed with message contest in the interface between clinical instruments and computer systems, The major topics are found in the following sections: ‘Character Structure 822 Seees San Intetsce Conaactons 524 ‘Connector 33 ashe $32 "This speiemion i under be juss af AST Commies E11 on nar oformatie ad i te it espa 9 Sabcommie ED 28 ‘cial Laboroy Sse. CCarent eden apeved Qet 10,1995 Pudin Jnsnry 198, Orginal bined ap £13819) Ls pros cian E381 -91 Eutabnent Phae (Lik Connacion) 8 Conenton ea ‘eget Pree . 8 ‘rae Number saz pesnonlesgrents faa Fecebe aru eas. ‘Terinain Phase (Unk Release ea Eno Recovary 65 (Detecive Free . 551 Recietas Message Carers 68 2. Referenced Documents 2.1 ASTM Standards. E 1394 Specification for Transferring ln Clinical Instruments and Computer Sy 22 ANSI Standards-! X3.4-1986 American National Standard Code for Informs- tion Systems—Coded Character Seis 7-Bit American "National Standard Code for Information Interchange (7- Bit ASCI) X3,15-1976 American National Standard for Bit Sequence ing of the American National Standard Code for Informa tion Interchange in Serial-by-Bit Data Transmission X3.16-1976 American National Standard. Character Struce ture and Character Parity Sense for Sctial-by-Bit Data Communication in the American Nations) Standaré Code for Information Interchange 23. 150 Standard? International Standard ISO 7498-1984( cessing Systems—Open Systems Inter formation Pro- rnection—Basic Reference Model, Intemational Orgarcatton for Stan- dardization 24 Other Dacument** EIA-232-D-1986 Invetface Between Dats Tecninal Equip ‘ment and Data Cireut-Terminating Equipment Employing Serial Binary Data Interchange Arnal Book of ASTM Sanderd, Vel 140 "Altheim America Nations Sundae tse 1 W. ADRES, 138 Fog, New Yar NY 10036. aval tm Eletrre ItisAsociaon, 29) 1 Set NE, Wak ingen. OC 20008,NOTICE: This standard has either been superseded and replaced by a new version or discontinued. Contact ASTM International (www.astm.org) for the latest information Gly & 1381 3. Terminology 3.1 receiver-—the device that responds to the sender and accepis the message. 3.2 sender—the device that has # message 10 send and initiates the transmission process 3.3 The parts of communication between instrument and computer ate identified by the following terms. The parts are hierarchical and are listed in order of most encompassing irs. 3.4 session—a total unit of communication activity, used in this standard to indicate the events starting with the establish- ment phase and ending with the termination phase, a5 de- scribed in subsequent sections. 3.5 message—a collection of related information on a single topic, used here to mean all the identity, tests, and comments seat at one time. When used with Specification E 1394, this tenn means a record as defined by Specification E1394, 3.6 frame—a subdivision of a message, used 10 allow periodic communication housekeeping such as error checks and acknowledgements, 4. Significance and Use 4.1. Nearly all recent major clinical instruments have provi- sion for connection to a computer system, and in nearly all laboratories that have implemented a LIMS, there is a need 10 er tthe laboratory's high volume automated instruments to “he waMS so that results can be transferred automatically. To seomplish this connection, both the instrument and the computer must have compatible circuits and appropriate sof- ‘wore, and there must be a proper cable to connect the two systems, 4.1.1 Without this standard specification, the interface be- tween each different instrument and exch different computer system is likely to be a different product. This increases the ‘ast, the chanees for compatiblity problems, and the difficulty Of specifying and designing 2 proper system. In addition, Interfaces for every instrument-computer combination may net be available, foreing expensive and time-consuming custom evelopment projects, 42 This standard specification defines the electrical param: tess, cabling, data codes, transmission protocol, and error ecovery for the information that passes between the insiru ‘meat and the laboratory computer. It is expected that future products from instrument manufacturers and computer system developers, released afier the publication of this specification, ‘will conform to this specification, and that will lead 10 plug-ogether compatibility of clinical insteurents and cont puter systems 5. Physical Layer 51 Overview—The mechanical and elec for serial binary data bit transmission betseed instrument and computer system ig deseribed in the physical layer. The & gy 4 point-to-point, a direct connection between two 52 Electrical Chavacteristics—The voluge and impedance le fied in for the generator and receiver cieuiis ars a8 sp ElA-232-D-1986 standard. S21 Signal Levels 52.1.1 For the data interchange circuits, a marking condi ‘ios corresponds to a voltage more negative thar mvinus three volts with respect to signal ground at the inieiace point. A spacing condition corresponds fo 2 voltage more oositive than plus three voles with respect to signal grown’ ol the interface poiat. 5.2.1.2 Binary state ONE (1) corresponds io the marking. condition; binary state ZERO (0) carresponi’s co the spacing, condition 5.2.1.3 The signal levels conform to the £14.25 standard 5.2.2 Character Structure 5.2.2.1 The method of data transmission is serial-by-bit star’stop. The order of the bits in a character is (1) One start bit, corresponding to a inary 0, (2) The data bits of the character, least significant bit transmitted first, (5) Parity bit, (4) Stop bit(s), corresponding to a binary | 5.2.2.2 The time between the stop bit of on character and the stat bit ofthe next character may be of any’ duration. The data interchange circuit is in the marking covsition beoween, characters, 5.123 Even parity comesponds to a parity bit chosen in such a way that there are an even number of OE bits in the sequence of data bits and parity bit, Odd panity coresponds to an odd number of ONE bits when formed in the same way. 5.2.2.4 All devices must be capable of serding and receiv- ing characters consisting of one start bit, eizht cata bits, no parity bit, and one stop bit. 5.2.2.5 The defoolt character structure consists of one start bit, eight data bits, no parity bit, and one stop bit. Eight data bit 2-0-1986 chieacter sets are allowed but not specified ) this standard ‘Other character structures can be used for specialized applic tions, for example, seven data bts, add, even, mark or space pity, or two stop bits. 5.22.6 The character bit sequencing, structs, and parity sense definitions conform to ANSI standards X3 15-1976 and X3.16-1976, 5.23 Speed: 5.2.3.1 The data transmission rate for instronssnts shall be at least one of these baud rates: 1200, 2400, 480°. or 9500 baud. ‘The preferred rate is 9600 baud and shovls be the default setting of the instrument when more than one bund rate is available, The computer system mustbave the ospabilicy forall four baud forcther 3.2 Devices may optionally have the « baud rates such os 300, 19 200, and 38 400 specialized applications. 524 0 5.24.1 The conforming connection spect point of interconnection hetween the face Connections here defines main of the ument and domain of the computer syst ig | and Fig, 2.) Within the domain of either éeviee, ony appropriate ‘connection system may be used, preferably wh suitable cable locking hardware. 52.4.2 The conforming connection utilizes a 25:position| connector, The connector contact assignmet are listed inNOTICE: This standard has either been superseded and replaced by a new version or discontinued Contact ASTM International (www.astm.org) for the latest information. Aly & 1381 - computer Conain (oe) oncoming FIG. 1 Connector Strategy for instrument Computer ‘onnection—Cable Mounted tom M1 ‘ contort scoters é cbntoraing ESanastion FIG. 2 Connector Strategy for Instrument Computer ‘Connections—Chassis Mounted ‘Table J. Connector contacts not listed are unused. The connec- tor contact assignments conform to the E1A-232-D-1986 stan ‘for the eirouits that are used. 2.4.3 Contact 1 is the shield connection, it connects tothe instrument's (the DTE) fame. The shield connection is left ‘open at the computer (the DCE) to avoid ground loops, There ‘will be no connections on any other pins. All other pins will be pen circuits 53 Mechanical Characteristics: 53.1 Connector: 53.1.1 The conforming connector associated with the in- strument is a commercial type DB-25P (subminiature D male) syle connector. The conforming connector associated with the computer is a commercial type DB-25S (subminiature D. female) style connector. The connector dimensions must cor- respond to those given in the EIA-232-D-1986 standacd, 53.1.2 When the conforming connector ofthe instrument is cable mounted, it shall be configured with a locking device such as No. 4-40 or M-3 thread female screw locking, hard: ware. When the conforming connector of the computer is cable ‘mounted, it shall be configured with a locking device such as No.4-40 or M-3 thread male screw locking hardware. (See Fig 53.1.3 When the conforming connector of either device is chassis mounted, it shall be configured with devices such as No. 4-80 or M-3 thread female screw locking hardware. The ‘mating cable connector shall use devices such as No, 4.40 of M-3 thread male serew locking hardware. (See Fig. 2.) TABLE 1 Connector Contact Assigamonts omen. Er Greot Dereon ER __ 7 Shes Te Gonnezicn Be “Rectvae Osten ua 53.1.4 When the conforming connector of the instrument is cable mounted and the conforming connecior of the computer is chassis mounted, then a change in the cable mounted locking hardware is necessary. 53.2 Cable—Any extension cables to connect the instru ‘ment to the computer require a female conne:tor on one end! t2 mate with the instrument and a male connecroron the other end to mate with the computer. Detaled requirements of an interconnecting cable are undefined but good engineering practice should be followed in selecting the cable and connec: tors, Shielded cable and connectors may be necessary 10 suppeess electromagnetic interface (EMI) Low capacitance cable may be necessary for long cable lengths or the higher dota rates, Appropriate connector locking hardware should be used at the conforming connectors. 6. Data Link Layer 6.1. Overview—The data link layer has procedures for link connection and release, delimiting and synch onism, sequential contral, enor detection, and error recovery 6.1.1 Link connection and release establish which system sends and which system receives information, Delimiting and synchronism provide for framing of the date and recognition of frames, Sequence control maintains the s=suential order of information across the connection, Error detection senses transmission of format erors. Emor revovery attempts (0 recover Irom detected exeoes by retransmyii2 defective frames fr returning the link to a neutal state from stherwise unrecoy- erable errors, 6.1.2 The data link layer uses a chars to send messages between directly con! ANSI X3.4-1986. Also, see Appendive X1 ASCI characters.) Some restrictions are ola ters which can appear in the message content 6.13 The data link mode of operation is on information with alternate supervision. | ‘one diretion ata time, Replies occur eft oriented protocol ted systems, (Se the coding ofthe ‘on the charac sway transfer of ation flaws inNOTICE: This standard has either been superseded and replaced by a new version or discontinued. Contact ASTM International (www.astm.org) for the latest information. - Ay & 1381 never at the same time, Its a simplex stop-and.wait protocol, 6.1.4 At times, the two systems are actively operating to tsansfer information. The remainder ofthe time the data link is in 2 neutral state, See the state diagram in Annex Al. 6.1.5 There are three distinct phases in transfering infor- ‘mation between instrument and computer system, In each phase, one system directs the operstion and is responsible for continuity of the communication. The three phases assure the actions of sender and receiver are coordinated. The three phases are establishment, transfer, and termination, 6.2 Establishment Phase (Link Connection) 6.2.1 The establishment phase determines the direction of information flow and prepares the receiver to accept informa- 6.2.2 The sender notifies the receiver that information is available. The receiver responds that itis prepared to receive before information is transmitted. 6.23 A system which does not have information to send rrormally monitors the data link to detect the establishment phase. Itacts as a receiver, waiting for the other system, 6.2.4 The system with information available iitiates the establishment phase. After the sender determines the data link is in a neutral state, it transmits the transmission control charactersto the intended receiver. Sender will ignore 4 ponses other than , , or . 0.2.5 Upon receiving the , the reesiver prepares to receive information. All other characters are ignored. It replies with the transmission control character signifying itis ready, With this sequence of events, the establishment phase ‘ends and the tansfer phase begins. 62.6 A receiver that cannot immediately receive informa- tion, replies with the transmission control character Upon receiving 6.27 Systems not having the ability to receive information always respond to an by replying with a , Systems not having the ability to send information never transmit an . 6.2.7.1 Contention—Should both systems simultaneously tragsmit an , the daia link is in eontention, The instrument system has priority to transmit information when contention occurs. Contention is resolved as follows: (1) Upon receiving a reply of to its transmitted is received, it replies with an of depending on its readiness (2) Upon receiving a reply of to its transmitted , the instrument must wait at leost I's before sending another ENQ>. 6.3 Transfer Phase— During the transfer phase, the sender “nits messages to the reesiver. The transfer phase contin us nl all messages are sent 6.3.1 Frames—Messages each frame contains a maximum of 247 characters (including frame ‘overhead). Messages longer than 240 characters are divided benween two or more frames. 6.4.1.1 Multiple messages are never combined ia a single nt in frames frame. Every message must begin ina new fame 63.12 A frame is ane of twa types, an intermediate frame or an end fame. Intermediate frames terminate with the characters , checksum, and . End frames terminate with the characters , checksum, and . A message containing 240 characters ur less is sent in a single end frame. Longer messages ace sen) in intermediate frames with the last par of the message sent in an end frame, ‘The frame structure is illustrated as follows: FN text Cl C2 «intermediate frame FN text Cl C2 — end frame where: = Start of Text transmission control character FN = single gigit Frame Number 0 to 7 text = Dats Content of Mesiage = End of Transmission Block transmission contol character = End of Text transmission control character CL = mostsignificant character of checksum 0 10 9 and AF a least significant character of checksum O09 and AtF » Carriage Return ASCII character = Line Feed ASCII character 63.2 Frame Number— The frame number permits the receiver to distinguish between new and retransmitted frames, It isa single digit sent immediately after the character. 6.3.2.1 The frame number is an ASCII digit sanging from 0 to 7. The frame aumber begins at 1 withthe frst ffame of the ‘Transfee phase. The frame number is increnacnted by one for every new frame transmitted, After 7, the frame aumber rolls over t0 0, and continues in this fashion 6.5.3 Checksum—The checksum permits the receiver 10 detect a defective frame, The checksum is =ncoded as two characters which are gent after the or charace ter. The checksum is computed by adding the binary values of the characters, keeping the least significant eisht bits of the result. 6.3.3.1 The checksum is initialized ta 2ero with the character. The frst character used in computing the checksum 1s the ffame number, Each character in the message text is ‘added to the checksum (modulo 256). The computation for the checksum does not include , the cliesksum characters, or the tailing and . 633.2 The checksum is an integer represented by eight bits, itcan be considered as two groups of four bits. The groups ‘of four bits are converted to the ASCI] characiers of the hexadecimal representation. The two ASCI! characers are transmitted as the Checksum, with the most sisnifcant charac st 6.333 For example, a checksum of 122 sa be represented checksum is 6.34 doknawledgments— After a frame stops ing until a ceply is received 6.3.4.1 The receiver replies to each frame. When itis ready sent, the senderNOTICE: This standard has either been superseded and replaced by a new version or discontinued Contact ASTM International (www.astm.org) for the latest information. ly = 1981 to receive the next frame, it transits one of three replies 10 acknowledge the last frame This reply must be sransmitted within the timeout period specified in 6.5.2. 63.42 A reply of signifies the last frame was received successfully and the receiver is prepared 10 receive another fame. The sender must increment the frame number and either send a new frame or temicate 63.43 A reply of signifies the last frame was not successfully received and the receiver is prepared ro receive the frame again 63.44 A ceply of signifies the last frame was received successfully, the receiver is prepared to receive another frame, but is a request to the sender to stop transmit- ting, (See the following section on receiver interrupts.) 6.3.5 Receiver Interrupts—The receiver interrap is a means for the receiver to request the sender to stop transmiting messages as soon a5 possible. 6.3.5.1, During the transter phase, if the receiver responds to a frame with an in place of the usual is a positive acknowledgment of the end frame, signifies the receiver is prepared to receive next frame, and is a request to the sender fo stop transmitting 5.3.5.2 The sender does not have to stop transmitting after iving the receiver interrupt request. IF the sender chooses to iunore the , the receiver must e-request the interrupt for the request to remain valid 6.3.5.3 If the sender chooses to honor the receiver interrupt request, it must fist enter the termination phase to renum the ata link t0 the neutral state. This gives the receiver an opportunity to enter the establishment phase and become the seader. The original sender must not enter the establishment phase for at least 15 s or until the recsiver has sent a message and returned the data fink to the neutral state 6.4 Termination Phase (Link Release)—The termination phase retuns the data link to the clear or neutral state. The ender notifies the eceiver that all messages have been sent 6.4.1 ‘The sender transmits the transmission control character and then regards the data link to be ina neutral state Upon receiving , the receiver also regards the data link to be in the neutral state. 65 Error Recovery— Methods are described which enable both sender and receiver to recover, in an orderly way, from rors in data transmission. 6.5.1. Defective Frames— A receiver checks every frame to guarantee it is valid. A reply of is transmitted for invalid frames. Upon receiving the , the sender rerans- mits the last frame with the same frame number In this way, transmission errors are detected and sutomatially corrected 65.1.1 Any characters occurring before the or of after the end of the block character (the or “PX>) are ignored by the receiver when checking the fame tame should be rejeoted becouse: (3) Any character errors ace detected (parity error, 22), (2) The frame checksum does not match the checkin computed on the received frame, (3) The frame number is not the same asthe last azcepted fame or one number higher (modulo 8). 6.5.1.2 Upon receiving a or any character except an SACKS or (a condition). she sender incre ments a retransmit counter and retransmit: 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 exicemely rare, but it provides a mechanism to escape from conition where the transfer phase cannot continue. 6.5.2 Timeouts—The sender and receiver both use timers to etect loss of coordination between them. The timers provide a method for recovery if the Communication line or the other Gevice fails to respond, 6.5.2.1 During the establishment phase, the sender sets a timer when transmitting the If reply of an , is not received within 15 5, @ timeout ‘occurs. After a timeout, the sender enters the termination phase. 6.5.22 During the establishment phase, ifthe computer (as receiver) detects contention, it sets a timer. If 1n is not received within 20 s, a timeout occurs. fer a timeout, the receiver regards the line tobe in the neutral state 65.23 During the transfer phase, the sender sets a timer when transmitting the last character ofa frame. Ifa reply isnot received within 15 s, a timeout occurs, \jier a timeout, the sender abons the message transfer by proceeding 10 the termination phase. As with excessive retransinissions of defec- tive frames, the message must be remerivered so it ean be completely repeated. 6.5.24 During the transfer phase, the 1ecciver sets a timer ‘when first entering the teansfee phase ox when replying to a frame, Ifa frame or is nat received within 30 5, 2 timeout occurs, After a timeout, the receiver discards the lat incomplete message and regards the line to be in the neutral 6.5.25 A receiver must reply toa frame within 15 s or the sender sill timeout. A receiver can delay is reaky for up to 15 5 to process the frame of to otherwise go bis). Longer delays cause the sender to abort the message. 6.5.26 Receivers that cannot process ine to keep up with a sender may cause messae inthe sender. A sender can normally store message, Storage space for more than one Gesirable but optional 66 Resiricted Message Characters— ages fast enough butfer overflows east one complete ngaing message is ne data link protocot is designed for sending character based message text. Restric~ tions are placed on which characters may appesr in the ‘message text. The restrictions make it simpler for senders and ites, Additional bog with software receivers to recognize replies and frame del characters are restricted to avoid inter controls for devices such as multiplexers 6.6.1 A character is not permis message text ican appear only a the las 6.62 None of the ten transmission corral characters, the foriiat effector control character, or four device contra! characters may appear in message text, Ths restricted charec- ters sre: , , , , , to appear in the hacacter of frame.NOTICE: This standard has either been superseded and replaced by @ new version or discontinued Contact ASTM International (www.astm.org) for the latest information. Aly & 1381 , , , , , , ANNEX (Mandatory Information) Al. STATE DIAGRAM ALL The state diagram is given in Fig, ALLL Sending Device eccost Timer Timed Ov' 8" represents modulo 8 represent asigament ofa value. “Timer: = 15" resus the timer 1S a6 used here Nore J—Amow atsocited normal text denotes 4 eandiion stow axocitedalicied ox denotes ation taken, FIG, Att Stata DiagramNOTICE: This standard has Contact ASTM International (www.astm.org) for the latest information. ly € 1381 APPENDIN (Nopmandatory Information) XL. SEVEN-BIT ASCH CODE CHARTS — —— sem | ssoncmce, | leasotomae Bere ATR era ge aye ra sanaiatgniapanccag 2 pala -|a2 B52 RK] 62 as eV eat a ge Is Li ie a ak le FIG, X1.4 Decimal Character Coda AST inenaonal kes ro poston spacing te vay fay pte hls aera in canecion wi any tam ered sth sarc Usor 3 tars are eprsay san’ a otra he ayo ay Such paler 2 Of ngement of sh fh 370 ary Ia own responsi Tis tana ssl '9 ain a ay tin by eresporsse acne commie and must be vowed Bi Rv 9" ane ‘eatrovises, ete eazcoves a milan You Cannte nue a rion of Sind ar! ‘and seul ba aaressoa'0 ASTM friamatna| Heaoouatrs You” conan wi cals cooks consdeaton af ama he fesponetietarnca esta wcn you may aon yo We! lout ements have fo! eee 2a hen Ja. = Irate your vows hnwn to ASTM Commitee on Standards, 2 tho adres srawn Colom Tie tonsa copie by AST intra, 100 Ba Hates Crive, PO Box C700, West Conshohachn A 1525-2968 ning Sates ndit rool angle ee mali cop) of tvs sondae’ oy be oblied by cota ASTI a ie 5308 farese or at 1032-095 (onan) 6/0832 88 (fas) or soracaghasm.ng (amar rough fe AST ce fama og her been superseded and replaced by a new version or discontinued.aq Designation: £ 1394-97 Standard Specification for Av Arena Mabon Sansa Transferring Information Between Clinical Instruments and Computer Systems’ ‘This sna issued unde he Fed designating E1394; he amber medi lowing he designation cial niopion os the are of cvs, the year of at evn. A muberinpusetese nce he year sete year of ‘st approval. A supercedes an edtonalchsigesiace tela evion or appr 1. Scope 1,1 This standard covers the two-way digital transmission of remote requests and results between clinical instruments and computer systems. [t is intended to document the common conventions required for the interchange of clinical results and, patient data between clinical instruments and computer sys~ tems. This standard specifies the message content for transfer- sing information between a clinical instrument and a computer system, It enables any two such systems to establish a logical link for communicating text co send result, request, or demo- ‘graphic information in a standard and interpretable form. This standard does not necessarily apply to general analytical insuoments in an industrial analytical nor research and devel- ‘opment setting 2 This standard specification is intended to apply 10 the structure of messages exchanged between clinical instruments, and computer systems by means of defined communications ‘otocols. Low-level communications protocols and data trans- Jer requirements are beyond the scope of this standard, A separate specification is available from ASTM detailing a standard for low-level data wansfer communications (see Specification E 1381). 13 This standard specifies the conventions for structuring the content of the messige and for representing the data elements contained within those structures. [tis applicable (0 all text oriented elinical instrumentation. It has been specifi- cally created to provide common conventions for interfacing computers and instruments in 2 clinical setting, It would also be applicable to imerfacing instruments in clinical practice settings, such a5 physicians’ offices, clinics, and satellite laboratories. Referenced Documents 2.1 ASTM Standards: E 1238 Specification for Teansfrring Clinical Observations Between Independent Computer Systemns* E 1239 Guide for Description of Reservation/Re Admission, Discharge, Transier (R-ADT) Systems. for "This specie is anes we jusition of ASTI Commitee E31 09 Healer Informatics aa sh ie reponsy of Sbeomnnites 3) 13 ot Cheat Labortoy Syn Comentetiion approved Ges 10, 1997 Paine plished ay E 1394-91, Las previous eiton 1598-91 ‘Arua Book of ASTI Sandia, ol 1401 b 1998 Ongeally ‘seyie @AST 100 Barat ome. Automated Patient Care Information System: E1381 Specification for Low-Level Protocol to Transfer ‘Messages Between Clinical Laboratory Instruments and Computer Systems? 22. ANSI Standards? X3.30 ANSI Information Sysicm Codes X3.40 ANSI Information Sysiem Codes 33.43 ANSI Information Sysicins Codes X3.50 ANSI Information Systems Codes 23 ISO Standards:* ISO 5218 Information Iovercharige-Representation of Hu ‘man Sexes. ISO 2955-93 Information Processing—Representation of SI and Other Units in Systems with Limited Character Sets ISO 8859-1: 1987 Information Processing—8-bit single~ byte coded graphic character sess—Part 1; Latin Alphabet No.1 23. Other Standards: BIA/TIA-232-E 3. Terminology 3.1 Definitions of Terms Specific 10 This Standard 3.LL bartery—a group of tesis ordered together, for ex- ample, an admitting battery. The term battery is used in the ‘document synonomously with the ierm profile or panel. The test elements within a battery may be characteristic of a single physiologic system, for example, iver funetion tess, oF many different physiologic systems. The battery is simply a conven: tion by which a user can order multiple tests by specifying 2 single name 3.1.2 component field—a sinyle data element or data cle- ments which express a finer agereyate or extension of data elements which precede it, For example, pars of a field or repeat field entry. AS an example. the patient’s name is recorded as last name, frst name, and middle initial, each of which is separated by a component delimiter, Components cannot contain repeat fields 3.1.3 download —data transmis from a computer systern to a clinical instrument. ‘valbie fom American Naonal Sissi, Wed SL, 6 oon, New York NY 10036, wade fom Iterana Sends Poise 56, Ca122, Geneva 0 Syitetn en, 1 Roe de Vente, Cinefh) & 1394 3.1.4 field—one specific tribute of a record which may contain aggregates of data elements further refining the haste aribute, 3.1.5 message—a textual body of information consisting of a header (H) record through a message terminator (L) record, 3.1.6 record—an aggregate of fields describing one aspect ff the complete message. 3.1.7 repeat field—a single data element which expresses a duplication of the field definition it is repeating. Used for demographics, requests, orders and the like, where each clement of a repeat field is (o be weated as having equal priority or standing to associated repeat fields. 3.1.8 test—a determination of a single analyte or a comii- nation of values from other determinations ot observations which constitute a measure of a single system attribute. 3.1.9 upload—data transmitted from a clinical instrument to computer system. ificanee and Use 4.1 General fnformation: 4.1.1 This specification provides for two-way wansmission allowing for data-flow in either direction. It provides for sending demographic and test information 10 ot from clinical instruments. This specification has sufficient flexibility 10 permit the addition of fields to existing record types or the creation of new record types to accommodate new test and reporting methodologies. 4.1.2 This specification is related to Specification & 1238 Both standards use positional convention o define the structure fof messages that exchange information about clinical test requests and results. The set of conventions specifies a hiera- chical set of records in which the records higher in the hierarchy contain information that is common to all records lower in the hierarchy and thus avoids redundancy in linking data together. The positional convention is simple and direct to implement, requiring only a sequence of strings each having variable length delimited fields which are positionally speci- fied 4.13 Specification E 1238, in its entirety, is not appropriate for use as a clinical instrament to computer system interface. The conventions of Specification E1238 regarding cecord types and the organization of data elements within the records have been adhered to as closely as possible to ensure that common data elements defined there and used within instruc ments are specified as closely as possible. This facilitates the use of this specification consistent with Specification E {238 in a number of settings. These are hues compelling reasons for developing a separate standard which deviates from Specific tion E 1238, 4.13.1 The scope of Speciiication E 1238 is specifically targeted to accommodate information transfer between two independent computer systems requiring shared ‘graphic and test result data, Specification E1238 conains extensive requirements and limitations, much of which may be of little, af any, use by clinical instrument systems. Fursher, clinical instruments have test and instrument specific requice iments outside the scope of Specification E 1238 and, as such, sie fot available within the existing Specification E 1238 4.1.2. The structure of Specification E 1238 provides areat atient demo- Alexibility in the ordering and sporting of test results and patient demographics. While this is appropriate for use by advanced computer systems of equivalent rank, Specification E 1238 clearly falls beyond the cochnicat limitations of many clinical laboratory instrumen's. This specification attempts 10 identify, and simplify, all complex data structures and interface procedures and, where practical. cesrict multiple procedural ‘options to single procedures appropriate forthe clinical instru- iment setting, Further, this specification has attempted to assign a masterislave hierarchy where conflicts may occur, assigning appropriate responsibility for vsia processing or reporting jperations to the pary (clinical instrument or computer 3y3- tem) better able to process a particular task, For example, in al cases involving the ordering or reporting of tests, the instru- ‘ment manufacturer is solely responsible for assigning the test and result ID numbers (see 6.5.1). These reductions in flex ibility directly result in increased structure and clarity, which is deemed more appropriate for cosuring successful interface implementation within the clinical instrument setting. 4.1.3.3 Specification E 1238 vas developed independent of data protocol and transfer consiccrations. Specification E 1238 uses maximum field and record! lengths, Combined with its record level checksum and ero recovery facilities, Specifica tion E 1238 may be implemented without a data protocol layer. By contrast this message-conien specification has been devel- oped in cooperative effort with » correlative ASTM low-level data transfer and protocol specification. While each specifics tion (message-content and low: evel protocol) is designed to be independently implemented ani maintained, the message content specification presumes thst a protocol layer exists that will handle record blockingic:biocking, error detection and recovery, and other associated data transport tasks. As such, all protocol level operations and limitations existing in Specifica- tion E 1238 are not applicable, and therefore not included in this document. 5, Information Requirements in Cli Sil General Approach 5.1.1 Messages may contain one of more requests/results for one or more patients. Tests may be requested as groups of many individual tests. These groups are referred to as batteries. amples of batteries are tests produced on a multichannel analyzer, such as a CHEMI2, physiological groupings of tesis (Guch as liver function tests) and Minimum Inhibitory Concen tration tests (MIC'S) in microbiology testing. The fact that a sefies of tests is contained in a battery dees not imply that they are all performed on the same analytic instrument. 5.1.2 Messages consist af a hierarchy of records of various lypes. Records a! level zero contain information pertaining {0 the sender identification and completion of transmission Records at level ane ofthe hierscchy contain information about Individual patients. Records a! (evel two contain information about test order eequests and spesimens, Records at level three contain information about test sets. 5.1.3 Comment records may be inserted at any level int hierarchy. A comment record a2 relates tothe immediately preceding patient, ofder, resuit, scientific or manufacturer information record. Therefore, \{ a comment record were 10 follow a patient record (level on), then that comment record ical Testingih © 1394 Using the transmission example as given in 5.21 and as outlined in Fig. 2, the following record recovery examples ‘would be vali. Line Fate Ossi Pecpces Raransmiaion Ot 5 Ae z hac 5 ABCO E ARCO F AREF 6 ARERG x AG, K AGHLYK t AGH KL « AGH LM N AGMN ° ANO ® AN a ANORO 6. Message Content—General Considerations 6.1 Character Codes 6.1.1 All data shall be represented as cigh-bit, single-byte, coded graphic character values as defined in ISO $859-1:1987, The eight-bit values, within the range from 0 19 127 of {SO '8859-1:1987 correspond to the ASCII standard character set. Values from 0 t0 31 sre disallowed with the exception of 7 (BEL), 9 (Horizontal tab), U1 (Venical tab), and 13 (CR), Where 13 is reserved as a record terminator Values from 32 (0 126 and from 128 to 254 are allowed, Values 127 and 255 are also not allowed. It is the responsibility of the instrument ‘vendor and computer system vendor to understand the repre- sentation of any extended or alternate character set being used ‘As an example, the numeric value 13.5 would be sent as Four-byte value characters 13.5 or Latin-1(89), Latin-I(S1), Latin-1(46), and Latin-1(53). ‘Aowed Characters: 7.9.1, 12,19, soa, 126-254 05,5, 30, 14-31, 127,255 6.1.2 Within text data fields, only the Latin-1 characters 32-126 and the undefined characters 128-254 are permitted as usable characters (excluding those used as delimiter characters in a particular transmission). Furthermore, all characters used as delimiters ina particular transmission are excluded from the permitted range. The sender is responsible for screening all ext data fields to ensure that the text does not contain those delimiters. Unless otherwise stated, contents of data fields shall be case sensitive. 62 Maximum Field Lengihs—This specification assumes that all fields are variable in length. No storage js allocated (except for the delimiter) for a cull field. When, for example, ten characters of data are entered within a field, only wen characters will be used. This specification does not define @ maximum length for any field or record and relies upon the receiver's buifering capabilities, and the logical layer’s wrans- ort facilities, (0 parse information into workable lengths for transmission and processing purposes. [cis the responsibility af the instrument vendor and computer system vender to agree on any arbitrary field or record truncation that may need to be imposed. Icis recommended that the instrument vendor provide documentation disclosing any field or record limits that will be mandated by the clinical instrument. 63 Maximum Record Leng! 6.4 Delimiters: 6.1 Alphanumeric characters should not be used as delim iters because they are likely to appear within field content Moreover, some alphabetic characters have special uses 25 follows: HPO.8C.05.Lm None imposed. reco oe Os atn(36) ‘roma! po ca) «ati comma SAC brety cases Cie Nu0.8.W foout codes GREXLO resut stats For the purpose of providing examples, the following delimiters are used in this spe ication: Fat ctirtr = varcal (att (124 Fepeat dirt = Backs Lt) (69 Compaen tr = et) ate (8) Escape dima = amps (8 Lat (8) 6.4.2 Record Detimiter—Carviage retum (13) shall be the delimiter for the end of any of the defined record types. 64.3 Field Delimiter—A single allowable characer as de- Fined in 6.1.1 excluding Latin-((13) (carriage return), shall separate adjacent fields. ‘The ‘cli delimiter is variable and defined in the message header The same delimiter must be used in all records following a header and preceding a message terminator record. 6444 Repeat Delimiter—A single allowable character as defined in 6.1.1 excluding Laiin-I(13) and the value for the field delimiter defined in 6.4.3. The repest delimiter must be defined in the message header and is used to separate variable numbers of descriptors for felis containing pans of equal members of the same set. 64.5 Component Delimiter single allowable character as defined in 6.1.1 excluding Latin-I(13) and the fetd and repeat delimiter values. The component delimiter is used to separate data elements of fils of a hierarchical or qualifier nature. For example the street, city, state, zip, et. of an address field would be separated by component delimiters. 6.4.6 Escape Deliniter—A single allowable character, 35 defined in 6.1.1, excluding Lavin-I(13) and the field, repeat, ‘and component delimiter values. The escape delimiter is used within text elds to signify special case operations. Applica- tions of the escape delimiter are optional and may be used or Jgnored at tbe discretion of either transmitter oF receiver However, all applications are required to accept the escape delimiter and use it to correctly parse fields within the record. 6.4.6.1 Use of Escape Delir’er—The escape detmiter may ‘be used to signal certain special characteristics of portions of a text field (for example, imbed2< elsmaters, line feed, carriage return, efe). An escape sequenc> consists ofthe estape delim- iter character followed by a single escape code ID (listed below), followed by zero or mor data characters followed by another (closing) occurrence of the escape delimiter character No escape sequence may contain a nested escape sequence. The following escape sequences are pre-defined. AHS sa nahiting et ANS malo (and ching) AFR Inedeng fac ceo chase ase I ante character RA bade repeat os Sarr charactergb & 1394 Aes embed Sacre spa debt chart lore |—Aay number of hexadecimal digits (0-9, AF) may follow Uthat is, XAG: sould equal line feed), ‘AZoeec® Lota mans deine) espa sequence Nort 2—Aay numberof tegal characters imay follow. 6.4. Specification of Delimiters—The actual delimiters to be employed in a given transmission shall Be specified in the header message. Its the responsibility ofthe sender 19 avoid the inclusion of any delimiter characters within the field contents. The receiving computer will determine what charac ters t0 use by reading the specifications of the header it receives. See 64.1 for examples of delimiters used for this document 6.48 Delimiters far Null Values—Fields shall be identified by their position, obtained by counting field delimiters from the front of the record. This position-sensitive identification oro- cedure requires that when the contents of the field are ull is corresponding field delimiter must be included in the record to ensure that the th field can be found by counting (é1) delimiters. Delimiters are not included for wang noll fields; that is, ifthe tenth field was the last fleld containing data, the record could terminate after the tenth eld, and therefore would contain only nine delimiters 649 Fields of No Concern 10 the Receiving System— ‘Transmitted records may include more fields than are required by a receiving system. When processing a message, the “eiving system may ignore any field it does aot require sls must abways be transmitted, however, in the positional onder specitied 6.4.10 Fields with Null Values: 6.4.10. & system may transmit a null value for a field because (/) itdoes not know the value, (2) it knows the value is irelevant to the receiving system, or (3) the value has not changed since the last transmission, oF any combination thereof. To exemplify case (3) a lab within a tightly linked hospital network may never transmit the patient's birthdate, 5X, race inthe patient record when tansmilting the order and result records (0 the requesting system, because it knows that the hospital registry system always broadcasts new or changed patient data to the receiving system. 64.102 Because the sending system can use null values to indicate no change, a mull value does act overwrite existing data in the receiving system, In rare circumstances, for example, if a system erroneously sent a patients bisthdate when the birthdate was actually unknown, the receiving system should replace its existing value for afield with a nul value 64.103 A field containing ofly 8 pair of double quotes (Latin-1(349) should be treated a5 an instruction to the receiver that the existing contents pertaining t0 that field definition should be deleted 6.5 Data Record Usage Overview—Data shall be ex changed in ecords of different types. Each recor is introduced by field (umber one) identifying the record type, and termi vd by a carriage return. The following record types are aed Nore 3-—The record type ID el shall he caze insensitive 65.1 Message Header Record (H)—this record shall con- tain information about the sender and the receiver, that is, it shall identify the instruments) and che computer systems whose records are being exchanged. It also defines the field, ‘repeat field, and component field delimiter characters 65.2 Patient Identifying Record (P)—This record type con: ‘ains information about an individual povient 65.3 Test Order Record (O}—Whes sent from the computer system to the instrument, his record sill represent atest order and may be followed by one or mors result records which ‘would contain information pertinent xo the test being ordered. ‘When sent by the instrument to the computer system, it shall provide information about the specimeiviest request, and may be followed by result records (atleast ove reeord for each test within the ordered batterie). 65.4 Result Record (R)—Each result record shall contain the results of a single analytic determination. 65.5 Comment Record (C)—Commeat records shall apply to any other record except the message trailer record. They may be free standing messages sent to or fom the instrument, unrelated to a particular patient or tes: procedure. 65.6 Request Information Record (()—This record shall be used fo request information for new tess, for tests previously ordered, and. possibly for tests previously reported. A single request information record may request demographic informa- tion, or results for an individual test, multiple test, or all tests, fora single date, a series of dates, or a ange of dates, or both, and for an individual patient, group of patients, individual specimens, groups of specimens, ete 6.5.7 Scientific Record (S)—This ecord shall be used (0 exchange results between clinical sites for the purposes of proficiency testing or method development. 6.5.8 Manufacturer Information Record (M)—This record, ‘whiei is similar to the comment recor, may be used to send complex structures: where use of the cxisting record types would not be appropriate. The fields wichin this record type are defined by the manufacture. 66 Common Field Types 6.6.1 Universal Test ID—This fell \s defined as a four part field with provisions to farther define te test identification vis, use of component fields, The test ID jcld is used to identify @ test or battery name. The four parts sshich are defined below are the universal tet identifier, the test rime, the test identifier {ype and the manufacturer defined test code. All est ID parts ‘must be separated by a component de'jniter and are position dependent. As an example, additions) in‘ormation which may be included in this field type are insinunent 1D, organism ID (for sensitivity tests), well umber. cup number, (cation number, ray number, bar code number. etc. [tis the responsi- bility of the instrument manufacturer io define the data content of the test ID field, When the tes 1D is sed in the result recor, there must be sufficient information wha the test ID field 10 determine the relationship of the test result to the test, batery or batteries on 66.1.1 Universal Test 1D (Part 1)—This is the first compo: nent of the test ID field, This field is currently unused but reserved for the application of a universal test idemifer code, should one system become available fo use ata Future timedh & 1394 6.6.12 Universal Test 1D Name\(Part 2}—This would be the test or battery name associated with the universal test ID code described in 6.6.1.1 6.6.1.3 Universal Test ID Type (Part 3}—In the case where multiple national or international coding schemes exist, this field may be used to determine what coding scheme is employed in the test ID and rest ID name fields, 6.6.1.4 Manufacturer's or Local Code (Part 4}—This is the code defined by the manufacturer. This code may be a number, characters, or multiple test designator based on manufacturer defined delimiters (that is, AK.23.34-B), Extensions or quali- fiers 10 this code may be followed by subsequent component fields which must be defined and documented by the manulac ‘ucer. For example, this cole may represent a three part identifier such as—Dilution” Diluent” Description 6.6.2 Dates and Times —In all cases, dates shall be recorded in the YYYYMMDD format as required by ANSI X3.30. December 1, 1989 would be represented as 19891201. When, times are transmitted, they shall be represented as HHMMSS, shall be linked to dates as specified by ANSI X3.43. Date and lime together shall be specified as up to a fourteen-character siting: YYYYMMDDHHMMSS. 6.6.2.1 Time Zone—The time zone may be optionally ap- pended to the dateltime field in the format + HHMM or ~ HHMM as appropriate. The defaule ime zone is that of the sender. 6.6.3 Telephone Numbers—Phone numbers shall be re- corded as free text, which may contain extensions such as area code, country code, beeper number, hours to call, ete 6.63.1 Multiple Phone Numbers—When multiple tele- phone numbers apply, they may fe included in one field and Separated from each other by repeat delimiters, The first such entry is considered the primary or the daytime number. 6.64 Fixed Measurements and Units—When a field con- tains a specific observation, for example, patient's weight, patient’s height, or collection volume, the default units of measurement for that observation are specified in the field definition, When the observation is measured in the default units, the units need not be transmivted. If the measure is recorded in units different from the default, for example, ifthe ‘weight is measured in pounds rather than kilograms, the ‘measurement units must be transmitted. In this case the units are transmitted in the same field as the measurement, The units follow the measure and are separated from it by a component delimiter, for example, 100° Ib. Units should be expressed in ISO standard abbreviations ia accordance with ISO 29: 6.65 Addresses—An address occupies single field in a record. The address may be comprised of five components (street address, city, state, zip, or postal code, and country code) Separated by component delimiters s0 that the re party can break them into separa fields as needed, An exam ple would be 52 Hilton Street #B42° Chicago" IL” 60305" USA The country need only be transmitted assumed from the context. The companents of this field are position dependent. 6.66 Provider and User 1D's—Physician's and other care sgivers’ codes may be transmitted as internal code numbers, a8 ull names, oF both, as muually agreed upon between the when it cannot be sender and the receiver. When boil) she name and ID number are sent, {D numbers should come first and be separated from the name by a component delimiter Each component of the name is also separated by a component delimiter. The order of the components of the name shall be (F) last name, (2) first ‘ame, (3) middle initial or name, (4) suffix, for example, J, Sr. ete., and (5) title, for example, De, Mr, ete. Thus, if Dr. John G. Jones, Jt. had an identifier of 401-0, his number and name would be transmitted as 41-0" JONES” JOBN”G" JR “DR. When necessary, more than one ID may be sent within ‘one field. Multiple IDs in one ficld are separated by repeat delimiters. 6.6.7 Record Sequence Number—This is a required field used in record types that may occur multiple times within a single message. The numer used defines the th occurrence of the associated record type ata particular hierarchical level and is reset to one Whenever a record of a greater hierarchical significance (lower number) is transmitted Or if the same record is used at 2 different hierarchical level (for example, comment records). 6.7 Examples of Basic Recor Types—The following ex- amples are given for a set of transiitted results for a given patient. These will show how the employment of the conven- tions defined lead to a valid messize. In these examples the first two fields of each line (record) of the message body contain the record type andthe intcaer record sequence number (excepting the header record), Cariage return is indicated by . To simplify the example, all the components of each record have not been inchided.Ellinses (..) are used to indicate fields that are left out and comments are enclosed in square brackets. Record hierarchical levels are shown by indentation. Nore 4—YYou may wish to study th record definitions outined in Section 7 before ceviewing the samplcs snown in Figs. 3-1. Trang fields, unused, may or may not have ‘ea delimiters transite. Both cases should be handled by the receivins parser 7. Message Header Record 7.1 General—The header shall contain identifiers of both the sender and the receiver. The mcssage header is level zex0 record and must be followed at some point by a message terminator record before ending ‘he session or transmitting HV aera Pltecrs On| ate Al |0.356 Plvscce> Ot) +rzecme 2) |o.eazeeR> rece Nove 1—This sample isnot receminced for implementation. Nove 2—Direction: instrament copter system, FIG. 3 Minimal Implementation (No Patient 10 oF Specimen !D)lh E1394 uy ecm P| ol |9a7se9)|-~“AN\""*aacee> sa]s|-""a4|0.295| ||| ||| 9e9052r152247. alalaz|0.312 |||] i9e0nn27 a2zsacen> el2| of) [927s ||*""A8\""“AcecR> 2]4)°°74s|3. 124 |||] ]39600527132622.em> l2|-~"xe| 1.097] |] |] 99e903171526—5 teers FIG. 4 No Patient ID; Specimen 1D and Multiple Results Shown another header record. This record type must always be the frst record in a transmission, 7.L.1 Record Type 1D—The character H identifies the record as a message header record, 7.1.2 Delimiter Definition—The five Latin-1 characters that immediately follow the H (dhe header ID) define the delimiters to be used throughout the subsequent records of the message. “The second character in the heaser record is he feld delimiter, the third character is the repeat delimiter, the fourth character is the component delimiter, and the fifth is the escape character. ‘Afield delimiter follows these characters to separate them from subsequent fields. Another way to view this is thatthe first field contains H and the second field contains the repeat, component and escape delimiters. Using the example delimiters, the first, six characters in the header record would appear as follows BI el 7.13 Message Control 1D—~This is a unique number or other ID that uniquely identifies the transmission for use in network systems that have defined acknowledgment protocols that are outside of the scope af this specification. Note that this, is the third field TAA Access Password—This is a level securitylaccess ‘password as motually agreed upon by the sender and receiver If this security check fails, the transmission will be aborted and the sender will be notified of an access violation. TAS Sender Name or 10—The purpose of this field is © define the manufacrurerinstrument(s) specific 10 this line Using repeat and/or component delimiters this field may reRect software or fimmware revisions, multiple instrament available om the line, etc. 7.1.6 Sender Street Address—This text value shall contain the street address of the sender as specified in 6.6.5 TAT Reserved Field—Ths field is currently unused! but reserved for future use 7.18 Sender Telephone: Nunber—This Feld identifies 0 telephone number for voice communication with the sender as specified in 6.653, 7.1.9 Characteristics of Sender—This field contains any characteristics of the sender such as, party, checksums, op: tional protocols, etc. necessary for establishing a communica: tion link with the send TAO Receiver 1D—This text value inclutes the name ar other ID of the receives. lis purpose 1s verification that the transmission is indeed forthe receiv TAAL Comment or Special inseructions—This ext shall contain any comments or special instuctions reiting to the subsequent reeoris 10 be transmitted 7.1.12 Processing 1D—Indicaic processed: PProcsction:Tea! message as coxang sander processing “Tea Atgsaga iad Sy > ner an Shoe ac have an Joe on ne system -Deouomien: ocean eto! re purpose of 3 deouRHg oe "0-Ovally Cont taesage is nia for te purpose ol Kansiting ually conelquatyagsraren of eco sta how this message is t0 be rove magnage te ba conpltes 26 T.L13 Version No—This valuc identifies the version level of the specification. This value is curently E 139-97. 7.1.14 Date and Time of Message-—This field consins the date and time that the message ss generated using the format specified in 6.6.2. 8, Patient Information Record 8.1 General—Each tine of the patient record shall begin with a record type and end with » cartiage eeturn. 8.1.1. Record Type—The character P identifies the record as «patient record, 8.1.2 Sequence Number—For the fist patient transmitted, 1 shall be entered, forthe second, 2 until the las as defines in 6.64. 8.13 Practice Assigned Patiens !D—This identifier shall be the unique ID assigned and used y the practice to identify the patient and his/her results upon return of the results of testing 8.1.4 Laboratory Assigned Porienc ID—This identifier shall be the unique processing number assigned to the patient by the laboratory, 8.1.5 Patient 1D No. 3—This ‘eld shall be optionally used for additional, universal or manufacturer defined identifiers (och as Social Security Account No}, a8 arranged berween ‘vansmitter and receiver, 8.16 Patient Name—The patient's name shall be presented in the following format: last name, frst name, middle ame or initial, suffix, and tide, and eae of these components shall be separated by’a component delimiver as described in 6.6.6. BLT Mother's Maiden Nome—The optional mother’s maiden name may be required 1 distinguish between patients ‘with the same biethdate and last same when registry files are very large. This name shall be presented as the mother's maiden surname, for example, Thompson. 8.1.8 Birthdate—The birthdate shall be presented in the standard format specified in 6.6 > 8.19 Patient Sex—This field shall be represented by M, F, oe U. 8.1.10 Patiens Race amples may be used Boek Oesenbnatic hile Origin—The following ex Jeo be eteed tes 8.11 Patient Address—Thi sweet address of the paient’s 6.065. 81.12 Reserved Field—This expansion. xt value shall record the ving addvess as defined in | 38 reserved for futureih & 1394 caesar Lb087 Souci Avene SunasehT305|319 1292 SOAS RE Shr ocacion alate thee FIG. 5 Request from Analyzer for Test Selections on Specimens 032980325-032088327 HivSuPSivo Rarer Lang? Sout AanurSter NY" 720519 312672291 SBLOTHSHR| CR (12723305787 auaceanaeeY AAS» ‘js josznzse =a nce» faloszoazaas|| te cae sonar [~"mu\"-aty|ace> Plz)2da| 5627-17-29 vom aten nc aspera ""unven"-ausccas [3}9as|250151-37 926 stow ane mR 9 josaesser "cuenta" en| een» niece FIG. § Response trom Computer System for Previous Request HiPsiP swore aban? Sounstem enue Buta Taso «129721 9S4STI PRED [rae 2306-07-45 tac ase" msc» e[sfseelty 196 1F seats ponisiv seth urine ptt |t0>tee crouth Ponhivale> [2}tjesteny enue 71, 600)pca> ofaonnenss||""rse|ncea> af) Be a ere» eats ele 2eeaytccre Ap] ise eltipearten ‘ofslosaerses "we asca> ja} 70.2940 ol jazvenses||"~ aku acces A)s) koje. 98cm» laltltensing a supe |e [2242 seen. 270 fam ALLE ne | sevens |" Liven|see> ALP everast|2zen> Apap tier at ]s0e> 2)3) ver rani y7 2m fe) wer cer 29cm jajszensze||-~a.ui secs fap. sec 1398320] tst-37 a2 snes uae MRO josey even acea> U3] as aeces (rent 19 Hial toplichty Rotates co Uvte vcer 1 Rial ar [ecm jst |7 See nel eariteens lajosasenna| ereaayecea> AIR[ vente At fncehe Tear 16 Weld Extieitly Relates to SHE? oer fe] vere a jdsen> #1 als} as} cree cal. cm» one onze» (bee CHEAT e205 tal -cmne res| cer» 7 emene clump. ecm» fai emena aaj. recty Afo|"ewene“efin deo shay tneme csr a] “enema? Been> aya) exe item FIG. 7 Results from Given Ordored Test Selections Shown in Various Formats 8.1.13 Patient Telephone Number: number formatted as defined in 6.6.3 Patient's telephone agreed upon between the sender and the receiver. Identifiers or 8.1.14 Attending Physician /O—This field shall identity the physician(s) caring for the patient as either names or codes, a8 ‘ames, oF both, should be separated hy component delimiters as specified in 6.6.6. Multiple pivysician names (for example, ordering physician, attending physician, referring physician)4g) E1394 tesjeSHO Harper aba? Sauron Avende Dug NYTOCOSEN9 412 OTRRUPHIBEETH BREEDS 191303279325 ALLce> FIG. 8 Request from Computer System to Instrument for Previously Run Results ‘HS )PSWO}aetLane2097 Sunway Aves 73C5I09 ARTE SOEST INNA [esa 150 257-17-2791 pow ALH > of asasers|[ "unease caster laf vacrsocens Pr ear ej vastjancn> faosvensz6|""culseen AB) se tires FIG. 9 Reply to Result Request oeeiPasamosn eran. SH PSSA 9q GeBOSOTOTASCORCR> 2n]s288251 Smite Samvels OOAOI NW |SR6 C Sweet FremcAaRDAL=NT SHENGIS:2°r romi7= 172% Panes oSODHZAIP Wert ROMMSPIERPLSPragt Cree ise 86-teartutue"POc OM EO)R e080" 1559 ASOEATIOGSE aN senso jorge SpmcaysCR> ake YUEiisnarens ERNE Rige-Biyoroous Hey Nec urea FIG. 10 Microbiology Order and Result-Download of Demographics and Order ivaypaccwor MoH BLSt]PI33=8580081078500 nysecasaprcee ‘fs |s7e'05]}*ac"“poscoma 1118111 11 sc [ore] on cram 0 emaroccs ame me rsoscer ee eset tan esac P0 250-50 we sence ]5 [an Dome costeoe|aesec 26|--an eana|oreen> tlr|'ssawoostea|iv 1.02.0 oe atheoe> 8) Re RNO"p'soEke3 po 259-500 my eery IN p soeace costa sec» Any“ tatearef nese OL oem 077.2 MIL U 26 TNE oot FIG. 11 Microbiology Order and Result-Upload of Finalized Results shall be separated by repeat delimiters 8.1.15 Special Field }—An optional text field for vendor use (each laboratory can use this differently), 8.1.16 Special Field 2—An optional text field for vendor 8.1.17 Patient Height—(Default in cms.) An optional au- ‘meric field containing the patient's height. The default units are centimetres. [F measured in terms of another unit, the units should also be transmitted as specified in 6.6.4 8.1.18 Patient Weight—An optional numer field. contain ‘the patient's weight. The default nits are kilograms. If rule copies) ol te sankdard may Be obained by cnacing ASTM alte above = ‘10-832 9585 pro, 610.892 3585 ag), oF serca Darn eg (era), Haugh he ASTI west (wen ast)