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Publication numberUS3831006 A
Publication typeGrant
Publication dateAug 20, 1974
Filing dateJan 19, 1973
Priority dateJan 19, 1973
Also published asCA1002205A1, DE2402492A1
Publication numberUS 3831006 A, US 3831006A, US-A-3831006, US3831006 A, US3831006A
InventorsJ Chaffin, W Ellis, H Heist, W Walters
Original AssigneeHoneywell Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Patient-specimen identification system using stored associated numbers
US 3831006 A
Abstract
A patient-specimen identification system provides error-free identification of a specimen or sample from the time it is taken from a patient to the time when the results of the sample analysis are reported. Machine-readable labels are attached to the patient and to each container in which a sample or sub-sample may be contained. The machine-readable labels each contain a permanently encoded unique random number. When a sample is taken from the patient, the labels attached to the patient and the sample container are read and the two numbers are stored in an associated manner. Similarly, when portions of the sample are transferred to sub-sample containers, labels attached to the sample container and the sub-sample container are read and the two numbers are stored in an associated manner. The sub-samples are analyzed and the analysis results are associated with the number on the sub-sample container label. The analysis results are then correlated to the patient's identity and the analysis results and patient's identity are printed out in an associated manner.
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Description  (OCR text may contain errors)

United States Patent [191 Chaffin, III et al.

[451 Aug. 20, 1974 i 1 PATIENT-SPECIMEN IDENTIFICATION Primary Examiner-Stuart N. Hecker SYSTEM USING STORED ASSOCIATED Attorney, Agent, or Firm-John S. Solakian; Ronald T. NUMBERS Rellmg [75] Inventors: John H. Chatfin, III, Minnetonka;

William D. Ellis, Bloomington; ABSTRACT Herbert Heist, IfIXCelSiOf; Wayne A patient-specimen identification system provides er- Bloommgton, 0f ror-free identification of a specimen or sample from Mlnn. the time it is taken from a patient to the time when the 73 A 2 H u I results of the sample analysis are reported. Machine- Sslgnee oneywe nc mneapo 18 mn readable labels are attached to the patient and to each Flledl J 1973 container in which a sample or sub-sample may be [21] Appl NO; 324,931 contained. The machine-readable labels each contain a permanently encoded unique random number. When a sample is taken from the patient, the labels Cl. 23/253 40/324, attached to the patient and the sample container are S 116/130 read and the two numbers are stored in an associated [51] Int. Cl .1 G06k 17/00, G09f 3/00 a n r, Similarly, when portions of the Sample are Fleld Search R, R; transferred to sub-sample containers, labels attached 23/253 R; 40/324; 116/130 to the sample container and the sub-sample container are read and the two numbers are stored in an asso- References Cited ciated manner. The sub-samples are analyzed and the UNITED STATES PATENTS analysis results are associated with the number on the 3,482,082 12/1969 lsreeli 235/6l.l2 sub-sample Container label- The analysis results are 3,565,582 2/1971 Young 23/230 then correlated to the Patients identity and the analy- 3,754,444 8/ 1973 Ure et al. 23/253 R sis results and patients identity are printed out in an associated manner.

27 Claims, 19 Drawing Figures lENT c S g PATIENT SAQAPLE 23mg? ANALYZER 12 lo I I 1 t x SAMPLE l I 2? glg A lNER SAMPLE E L I SAMPLE l D/E READER 2 2 J SUBSAMPLE j *1 SAMPLE CONTAINER R x y Elks/2% 1 san -1. 1% E24 SEHELE LA EL TEsT TEMP' y 2 RESULTS MEMORY i 2 205 X y READER READER *2 *5 D/E "2 y l: 25 I so a 21 Y L [B/E 3 D/E *4 I y y I J 26 31 PATIENT IDENTIFICATION u i[TES T Rl-I S L Jl 1: as 32 F PRINTER LOGIC MEMORY PATIENT |.D TEST RESULTS PAIENTED M 3.881.006

sum 02 0f 13 READ TRIGGER PIN E lst OCTAL men LABEL IDENTIFICATION O I O O 4 K jZnd OCTAL DIGIT 4m OCTAL DIGIT 2 PARITY BIT FOR 3rd84th PARITY BIT FOR lsi8I2nd OCTAL DIGITS OCTAL DIGITS F/G. 2a

PATIENT LABEL P76. 20 F/G. 26

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BLOOD TEST DRAWING up CONTANER LABEL LABEL PATENTEnwszmem sum ou or 13 TO DRIVE CIRCUIT TO SENSE CIRCUIT T Wu RC DR 06 T PATENTEDMIBZO'W s',ea1;o0s

sum 07 0F 13 2nd 3rd,4ih ROWS SUBSAMPLE CONTAINERS SAMPLE PATENTEDmszmm SHEET 0a or 1 QQGBm PATENTLU K119301974 3,831,006

saw 'us nr 13 STATION PATENTED M2 3.881.006

' sum '10 or 13 TEST CUP NUMBER DISPLAY 7 I TEST CUP NO.

DATA I I TRANSFER POWER H4 DATA/ INDICATOR 67 ,f RECIEVED ON 5 1 1 3 l l 1.

OFF

mamas AUBZ 01974 saw n or 13 250 DICLAN D'CLAN PRINTER DECIMAL OUT-OF- DATA DATA o RANGE INPUT ENVELOPE COIESERTER ALARM ALARM I ALARM TO MEMORY AND LOGIC OUT-OF RANGE ALARM DATA ENVELOPE ALARM IO IO' IO IO IO' IO r Ll U SAMPLE ST ACCESSION RESULT NUMBER I I l I I l l I I I l l I O 0.2 0.4 0.6 0.8 L0 L2 L4 L6 L8 2.0 2.2 2.4 2.6

TIME (SECONDS) PATENTEDAUBZOISM 3831006".

sum 1213f 13 TO MEMORY AND LOGIC ADDRESS SECTOR LOCATION CONTENTS A+x PATIENT ID 3 C+z B+y a INDIRECT BIT # Q PATIENT D TEsT RESULT 5 PATIENT ID TEs RESULTS PATENTEDAHBZOIW 3.831.006

SIEU '13 Bf 13 Rs l D EXECUTIVE CREATE FILE LOAD TABLE A ALPHA ETIZE DATA INPuT DATA OUTPUT DELETE FILE READ BLOCK PORTABLE YES -CHECK PARITY LOAD TABLE B -CONFIRM TRANsNIIT READ BLOCK RANSFE CHECK PARITY STATON LOAD TABLE C -CONFIRM TRANsMIT READ DATA LOAD TABLE D AUTOMATED YES READ BLOCK INsTRuII/IEN CHECK PARITY LOAD TABLE E CONFIRM TRANsMIT ACCESS TABLE D YES STORE IN BUFFER CORRELATIo ACCEss TABLE E INDIRECT SEARCH sTORE IN PATIENT FILE sEARCH FILE DATA -PR|NT RESULTS HANDLING YES sEARCH DATA AND TABLES UTPU PR|NT RESULTS PATIENT-SPECIMEN IDENTIFICATION SYSTEM USING STORED ASSOCIATED NUMBERS BACKGROUND OF THE INVENTION The present invention relates to a system for analyzing samples from a bulk quantity and reliably reporting the analysis results. In particular, the present invention relates to a system and technique for error-free identification of results of specimen analysis with the patient from whom the specimen was taken.

The process now used in hospitals and laboratories for analysis of samples from patients is very complex. The process may require the handwritten transfer of the patients name or number as many as twenty times between the time that the sample is taken and the time that the analysis results are reported to the physician. The large number of times the name or number has to be transferred greatly increases the chance for human error. In large hospitals, analysis of samples from many different patients is being performed at the same time. The chance for error in identifying the analysis results with the proper patient is unsatisfactorily high. An error may result because the sample was drawn from the wrong patient, because the sample container was incorrectly marked, because the label on the sample container was accidentally transposed during transit or processing, or because the label was misinterpreted. The results of an error may be fatal.

To solve this problem several systems have been proposed in which identification is carried from the patient to the final test results through a series of mechanical or electro-mechanical transfers of the identification data from the patient to a container and then from one container to another. For example, the system described in US. Pat. 3,618,836 by D. J. Bushnell et al. involves punching a coded number into a tag which is attached to the patients wrist. When a blood or urine specimen is taken, the nurse or technician uses special equipment to punch the same coded number into a tag attached to the specimen container. At each subsequent transfer of a portion of the specimen from one container to another, the tag attached to the new container must be punched with the same coded number. Similar systems are shown in the following US. Pat. Nos.: 3,656,473 by Sodickson et al; 3,565,582 by R. R. Young; 3,526,125 by S. R. Gilford et al; 3,523,522 by E. C. Whitehead et al; 3,320,618 by B. L. Kuch et al; and 3,266,298 by E. C. Whitehead et al. These systems have several disadvantages. First, the hardware required for the mechanical or electro-mechanical transfer of the patients'number from one container to another is quite complex. Second, errors may still arise in the transfer of data from one container to another.

SUMMARY OF THE INVENTION The present invention provides a method and system for reliably identifying the analysis results with the patient from whom the sample was taken. No manual, mechanical or electro-mechanical transfer of the patients number from one container to another is performed.

Machine-readable labels are attached to the patient and to each container in which a sample or sub-sample may be contained. The machine-readable labels each contain an encoded random number. The patients identity and the number encoded on the label attached to the patient are stored in an associated manner.

When a sample is taken from the patient, the labels attached to the patient and the sample container are read and the two numbers are stored in an associated manner. Similarly, when portions of the sample are transferred to sub-sample containers, the labels attached to the sample container and the sub-sample container are read and the two numbers are stored in an associated manner. The sub-samples are analyzed and the label attached to the sub-sample container is read. The number of the sub-sample label is associated with the results of the analysis. Finally, the analysis results are correlated to the patients identity and the analysis results and the patients identity are recorded in an associated manner.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a schematic representation of a preferred embodiment of the patient-specimen identification system of the present invention.

FIGS. 2, 2a-2c shows a machine-readable label for a patient-specimen identification system.

FIG. 3 shows the coding of the machine-readable labelsof FIG. 2.

FIG.'4 shows the read head for reading the machinereadable labels of FIG. 2.

FIG. 5 shows amagnetic switch element of the read head of FIG. 4 when a hole is encountered in the coded label. 1

FIG. 6 shows a magnetic switch element of the read head of FIG. 4 when no hole is encountered in the coded label.

FIG. 7 is a schematic diagram of the electronics associated with the read head of FIG. 4.

FIG. 8 shows a portable console for reading and stor ing the wrist label'number and the sample number.

FIG. 9 shows a transfer station in which the sample is transferred to various sub-sample containers.

FIG. 10 shows a transfer station console for reading the sample and sub-sample numbers.

FIG. 11 shows an automated test instrument for use in a clinical chemistry laboratory.

FIG. 12 shows a test station console for reading the sub-sample number.

FIG. 13 shows a data entry system for interfacing a Honeywell Diclan 240 clinical analyzer with a Honeywell H1602 computer.

FIG. 14 shows typical signals which are transmitted to the computer by the data entry system of FIG. 13.

FIG. 15 shows a reader and data entry means for use with a manual test station.

FIG. 16 is a table illustrating a preferred correlation technique.

FIG. 17 is a flow diagram.

DESCRIPTION OF THE PREFERRED EMBODIMENT In FIG. 1 is shown a schematic representation of a preferred embodiment of the patient-specimen identification system of the present invention. The system described in FIG. 1 is concerned with a clinical chemistry laboratory. It is to be understood, however, that the system may be used in other hospital laboratories, or in other systems in which samples are taken from a bulk quantity having an unique identity and in which identification of the analysis results with the bulk quantity must be made.

When a patient enters the hospital he is given a wristband at the admission desk 11. Ordinarily the wristband contains his name, his hospital record number, and other information. To the wristband will be attached a machine-readable label 12 containing a unique random number x from a first set of random numbers X. To provide additional reliability, random number x may also be encoded on label 12 in a humanreadable fashion. Random number x is a temporary number to be used as long as patient 10 is in the hospital. Label 12 is selected at random. Random number x and the patients identity (for example his name, social security number or hospital record number) are entered into memory 13 by first data entry means 14. The patients identity and random number x are stored in memory 13 in an associated manner.

When a test request for a particular patient reaches the laboratory, a technician takes several sample containers 15, the test request, and several sample container labels 16 to the patients room. If a blood sample is requested, sample container 15 may comprise a blood drawing container such as a Becton-Dickenson Vacutainer. Sample container label 16 may be permanently attached to sample container 15 or may be capable of being attached and removed from sample container 15 at will. Sample container label 16 is encoded with a machine-readable unique random number y from a second set of random numbers Y. Random number y may also be displayed on sample container label 16 in a human readable number.

In the patients room the technician takes a fluid or tissue sample from patient 10 and places it in sample container 15. Sample container 15 will have a sample container label 16 attached to it before the sample is placed in sample container 15, or the technician will attach sample container label 16 to sample container 15 at the time that the sample is taken.

By means of first reader 17, the technician then reads label 12 and sample container label 16. First reader 17 is a portable device and may be incorporated as part of the technicians test tube tray. Random number x and random number y are stored in a temporary portable memory 20, which may also be a part of the technicians tray. Random number x and random number y are stored in temporary memory 20 in an associated manner. Additional data may also be stored with the associated pair in temporary memory 20. For example, it is often useful to record the time at which the sample was taken.

When the technician has finished her rounds, she returns to the laboratory and connects temporary memory 20 to second data entry means 21. Random number x and random number y and associated data are transferred from temporary memory 20 to memory 13 by data entry means 21. Random numbers x and y are stored in memory 13 in an associated manner.

In the laboratory, the sample is split into several smaller samples, each of which will go to a test instrument for analysis. Sample transfer station 22 divides the sample into sub-samples and transfers thesubsamples to various sub-sample containers 23. Attached to each sub-sample container is a sub-sample container label 24. Encoded on each sub-sample container label 24 is a unique random number z from a third set of random numbers Z. Second reader 25 reads sample container label 16 and sub-sample container label 24 at the time of transfer of the sample to sub-sample containers.

Random numbers y and z are directed by reader 25 to third data entry means 26. Random numbers y and z are then directed by third data entry means 26 to memory 13, where they are stored in an associated manner.

The sub-sample containers are then taken to an analyzer 27, which may comprise an automated test instrument or a human operated tester. Sub-sample container label 24 is read by third reader 30 and random number 2 is directed to fourth data entry means 31. The sub-sample is analyzed by analyzer 27 and the test results are directed to fourth data entry means 31. Random number z and the corresponding test results are directed by fourth data entry means 31 to memory 13 in an associated manner.

At this point in the system, all of the necessary infor mation has been entered into memory 13. Four associated pairs of identification information exist in memory 13 for each test result. These are: the patients identity and random number x which were entered at the time od admission; random number x and random number y, which were read and temporarily stored when a sample was taken from the patient and which were later entered into memory 13; random number y and random number z, which were entered at the time of division of the sample into sub-samples; and random number z and the test results, which were entered at the time of the analysis by analyzer 27. Logic means 32 takes thefour associated pairs and correlates the test results with the patients identity. Logic means 32 then directs printer 33 to print out the patients identity and the test results in an associated manner so that they may be used for diagnosis.

Logic and Memory The use of a general purpose digital computer as logic means 32 and memory 13, is particularly advantageous in the present patient-specimen identification system. Many hospitals already utilize a digital computer for other purposes such as billing and accounting. By appropriate hardware and software integration, a digital computer may be time shared between the patient-specimen identification system and other, unrelated uses.

In one successful embodiment of the present invention, logic means 32 and memory 13 comprise a Honeywell H1602 computer. For the purpose of fur ther discussion, this preferred embodiment of the present invention using the H1602 computer will be specifically described. It should be understood, however, that other digital computers or any dedicated logic/memory unit may be used.

Labels FIG. 2 shows preferred embodiments of machinereadable labels for a patient-specimen identification system. For the purpose of discussion, the coding on the labels comprises a fourteen hole pattern representing four octal digits, two label identification bits, and two parity bits, as shown in FIG. 3. The readers described in later sections of the specification are shown as being adapted to read the fourteen hole pattern. It should be understood, however, that the present invention is in no way limited to a particular type of label or a particular coding system.

FIG. 2a shows one preferred embodiment of the label which is attached to the patient. A flexible band 40 is adapted to be attached to the patients wrist. Flexible band 40 contains written information about the patient, such as his name, social security number, and the like. Patient label 41 is a slotted circular member, preferably of molded plastic, which slides over a flexible band 40. Since label 41 slides over the flexible band, it may be reused after the patient has left the hospital.

Each patient label 41 is uniquely coded with a fourteen position hole pattern and a read trigger pin. The fourteen hole pattern represents four octal digits and two parity bits, as shown in FIG. 3. The read trigger pin is a different size or shape from that of the holes of the hole pattern. The read trigger pin activates the reader so that the machine-readable number contained in the fourteen hole pattern is read. The use of a read trigger pin also insures the label is aligned properly with respect to the reader.

FIG. 2b shows a machine-readable label which may be used with a Vacutainer or test tube. Label 42 is a circular collar which fits around the Vacutainer 43. As with patient label 41, sample label 42 has a fourteen hole pattern encoded in one surface.

FIG. 2c shows a sub-sample label 44 which may be attached to a sub-sample container 45 such as a test cup for an automated instrument. Sub-sample label 44 is a toroidal body which press fits over the mouth of the test cup 45. A fourteen hole pattern is encoded on the label.

It is highly desirable to use a single type of read head which is capable of reading all three types of labels. This allows the portable console and the transfer station console to have only one read head each rather than two. By the use of a single read head the mechanical and electrical hardware of the portable console and the transfer station console is significantly reduced.

While it is desirable to use a single type of read head to read all three types of labels, it is necessary that the reader be able to distinguish between the different kinds of labels. Although this identification feature can be achieved in many ways, one advantageous way of distinguishing the three types of labels utilizes the two label identification bits of the fourteen hole pattern. For example, a patient label may be identified by having both bits being a digital l The Vacutainer label is identified by having the first bit be a digital l and the second bit be a digital 0. The test cup label is identified by having the first bit be a digital O and the second bit be a digital I.

In a preferred embodiment, the labels contain a human-readable representation of the machine-readable number. This makes manual back-up procedures possible. For example, the Vacutainer (sample) number can be written on the test request and the test cup (subsample) number can be written on the laboratory work lists or in data books. In addition, the use of a humanreadable number allows easy location of particular samples to repeat tests.

READERS sure through sense winding 54 generates a signal indicating a digital 1. As shown in FIG. 5, most of the magnetic flux passes through sesse winding 54 when flux closure block 51 is in contact with ferrite C core 52.

When push rod 55 encounters no hole in the coded label, push rod 55 pushes flux closure block 51 away from ferrite C core 52 thus opening the flux closure path. As shown in FIG. 6, in the open position very little magnetic flux passes through sensing winding 54 when a current pulse is applied to drive winding 53. The signal produced when the push rod encounters no hole is designated a digital 0.

READ ELECTRONICS FIG. 7 shows the electronics used to sequence the read head having magnetic switch elements as it reads the precoded pattern stored on the labels. When the read head and the label are brought into contact, the read trigger pin causes switch S1 to close. Oscillator control 60, which may comprise a flip flop, starts oscillator 61. Oscillator 61 drives counter 62 and timing circuit 63. Counter 62 counts from 1 to 8. The output of counter 62 is decoded'by decoder 64, which sequentially addresses transistors Q1 through O7. As each transistor turns on, it supplies current to two series connected drive coils mounted in the read head. This current produces a voltage on the sense winding whose amplitude is proportional to the distance between the C core and the closure'block. For example, the output of decoder 64 which is associated with the count of 1 turns on transistor Q1. When transistor Q1 turns on, current flows through the drive line to drive coils'lA and 1B which are connected to two different C cores. Signals then appear on the secondary windings 81A and SIB; If the ferrite closure block is pressed closely to the C core, the signal is large enough to overcome the diode drop and appear at the input to a sense amplifier. The signals from the sense windings are amplified by sense amplifiers A or B, depending upon which one is strobed by timing circuit 63. When sense amplifier A is strobed, the signals from sense coils SlA through S7A are read out sequentially. This produces the first seven bits. When counter 62 begins counting from 1 to 8 a second time, sense amplifier B is strobed. Coil drive transistors Q1 through Q7 are again sequentially addressed. The signals from sense windings SIB through 57B are amplified by sense amplifier B and constitute bits 8-14.

The signals from sense amplifiers A and B are directed to OR gate 65. The fourteen bit output signal from OR gate 65 is directed to a temporary memory or a data entry device. In addition, bits 3-6 and 8-13 are directed into 12 bit shift register 66. Label identification bits 1 and 2 and parity bits 7 and 14 are not stored in shift register 66. The stored bits are then decoded and displayed by display means 67. When the read operation is complete, timing circuit 63 provides a signal to oscillator control 60, which turns off oscillator 61.

Portable Console FIG. 8 shows a portable console for reading and storing the wrist label number x and the sample number y. The portable console is incorporated in the technicians tray which is carried by the technician to the patients room when samples are to be taken. A hand held wrist label reader 101 is used to read the number encoded on the patients wrist label and the number encoded on the Vacutainer label.

Read electronics similar to those shown in FIG. 7 are included on the console. The read electronics are powered by a battery contained in the console. In order to minimize the power requirements on the battery, two power levels are maintained. A continuous power level is used for memory maintenance. The temporary memory contained in the portable console may, for example, be a semiconductor memory. It is therefore necessary to maintain continuous power to the memory so that the information will not be lost. The second power level is used for the read operation. Power is supplied to the read electronics only during the read operation. The read trigger pin triggers a switch which turns the power on when the read head and the label are brought into contact.

When the technician enters the patients room, she removes the Vacutainer from a first rack 110 of her tray. As she fills each Vacutainer, she places it in a second rack 111. After the required number of Vacutainers have been filled, the patients wrist label is read by bringing label reader 101 in contact with the patients wrist label, causing the wrist label number to be transferred to the portable memory.

After the patients wrist label is read, the label on each of the Vacutainers in rack 111 is read and transferred to the portable memory. Random number x is stored in a buffer memory which is read each time a Vacutainer label is read. These two numbers are then stored in the temporary memory. This arrangement avoids having to read the patients wrist label each time that a Vacutainer label is read. After each of the Vacutainer labels have been read, the Vacutainers from rack 111 are transferred to rack 112.

The portable console optionally may contain display means for visually displaying random numbers x and y as read by the reader. This allows the technician an opportunity to visually perform a check to determine if the numbers were correctly read.

When the technician returns to the laboratory, data is transferred from the temporary memory into memory 13. An electrical connection between memory 13 and the portable console may be made through data transfer terminal 113. When the data has been entered into memory 13 and properly stored, a signal is sent to the portable console which causes data transfer indicator 114 to indicate that the data has been properly received.

It is often desirable to record additional information along with the wrist label number and the Vacutainer numbers. In particular, it is often useful to have a record of the time at which the sample was taken. In one preferred embodiment of the present invention, therefore, an oscillator and counter are provided inside of the portable console. When the technician is about to leave to take samples from patients, she makes electrical contact with memory 13 and logic means 32 through data transfer terminal 113. The count on the counter as well as the actual time from the clock in logic means 32 are stored in memory 13. In one embodiment the count is zero and the oscillator is started by making electrical contact. In another embodiment, the oscillator is free running and the count on the counter is some random number r. Each time a Vacutainer label is read, the count on the counter is stored in the temporary memory along with the associated random numbers x and y. From this information the time that the sample was taken can be obtained. In the embodiment in which the initial count was zero, the actual time of taking the sample is the initial time when the technician made electrical contact to the memory plus the count times the time increment between counts of the oscillator. In the second embodiment in which the initial count was random number r, the actual time of taking the samples is the original time stored plus the stored count minus the original count times the time increment between counts of the oscillator.

TRANSFER STATION In FIG. 9 is shown a transfer station in which blood from the Vacutainers is transferred to various test cups. As shown in FIG. 9, each Vacutainer is arranged in a column with the test cups. Blood is transferred from a Vacutainer to each of the test cups in the column. This transfer may be done manually or by automated techniques. The read head sequentially reads the Vacutainer label and then each of the test cup labels in a column. The read head may be hand held, as shown in FIG. 9, or may-beincorporated in automatic apparatus.

FIG. 10 shows a transfer station console. The apparatus and operation of the transfer station console is similar to the portable console. Similar numerals have therefore been used to designate similar elements. Since it is desirable to avoid reading the Vacutainer label each time one of the test cup labels is read, a buffer memory is provided to store the Vacutainer n-umberwhile each one of the test cup labels is read. Each time a test cup label is. read the buffer memory containing the Vacutainer number is also read. The associated pair of numbers is sent to memory 13. Data re ceived indicator 114 indicates that the associated pair has been received and properly stored in memory 13.

AUTOMATED TEST STATION One highly advantageous automated test instrument for use in a clinical chemistry laboratory is the Honeywell Diclan 240 clinical analyzer. A patient-specimen indentification system utilizing the Diclan will therefore be described. It should be understood, however, that other automated test instruments may also be used.

FIG. 11 shows a Diclan 240 clinical analyzer. Test cups containing sub-samples are received from the transfer station and placed in a sample chain 150. As sample chain is sequentially advanced, sub-sample extractor removes the contents of each test cup and transfers the contents to a Diclan test cup. The Diclan test cups are arranged in a test chain. The first subsample extracted is placed in thefirst Diclan test cup, and so on. Thus the order of the sub-samples is maintained throughout analysis.

Testcup label reader reads the test cup labels in the same order that the samples are extracted. In other words, the first label read corresponds to the first sample extracted. Since the order of the sub-samples is maintained throughout analysis, the first test cup number read is associated with the first test result produced by the Diclan. It can be seen that the test cup label may be read immediately before, after, or concurrent with sub-sample extraction. The important feature is that the labels are read in the same order that the subsamples are extracted.

In present laboratory procedures, even in laboratories with computerization, a load list is typically made for automated instruments. This means that the samples must be placed in the instrument transport system in a prescribed order. This has several disadvantages: (a) mis-ordering causes results to be attributed to the wrong sample; (b) the instrument may not be started until all samples have been received and are in place; and (c) rush or emergency samples must either be placed at the end of the line when they arrive or the load list must be modified in a time-consuming step. With the present invention, these problems do not exist and the samples may go into the sample transport in any order since they are identified at the time the sample is entered into the instrument for analysis.

FIG. 12 shows a test station console. The apparatus and operation of the test station console is similar to the portable and transfer station consoles. Similar numerals are therefore used to designate similar elements. As shown in FIG. 11, read head 101 is preferably mounted in an atuomatic mechanism rather than being hand held. In such an embodiment, the test cup labels are provided with an alignment pin or' notch so that the labels are all aligned in the same direction in thesample chain.

In FIG. 13 is shown the data entry system for interfacing the Diclan 240 clinical analyzer with the Honeywell I-I1602 computer. To understand the operation of this data entry system, it is first necessary to understand the generation and output of signals from the Diclan 240 clinical analyzer. A three digit sample accession number is displayed on a counter, and a three digit test result is displayed on Nixie tubes in the Diclan 240 clinical analyzer. Both numbers are also output to a printer 250.

The sample accession number is a sequential count of the Diclan test cups as they are analyzed. 'A starting ring is placed on the first Diclan test cup in a batch of samples to be tested, and subsequent test cups are sened by a Microswitch, which generates a positive pulse for each test cup. These pulses are counted and the count is held in a three digit electro-mechanical decimal counter.

Test results are generated by a photometric measurement. The photometer output with no test sample present charges a reference capacitor. The amount of the charge on the reference capacitor may be modified by calibration potentiometers. When the test sample is in place in the photometer beam, three events take place: an oscillator gate is opened; the reference capacitor begins discharging in smallincrements; and a comparator starts comparing the photometer output voltage with the voltage on the reference capacitor. The gate directs the oscillator pulses to the test result binary coded decimal (BCD) counter. When the reference and test sample voltage are equal the comparator shuts off the oscillator gate. Thus the number of oscillator pulses is proportional to the test result.

Data is transmitted to printer 250 by a set of ten digit lines. Six decimal digits (three for the sample number, and three for the test results) are sent serially in an interval of approximately two seconds. The transfer is initiated by a timing cam, and the transfer sequence is controlled by gating pulses under the direction of printer 250. The sample accession number is transferred to printer 250 first. A gate pulse applies voltage to the 10 electro-mechanical decimal counter. The ten outputs of each of the electro-mechanical counters are connected to the ten data transmission digit lines, so the gate pulse causes the appropriate 10 digit to be transferred to printer 250. The 10 and 10 electromechanical counters are gated in sequence to complete the transfer of the sample accession number. This procedure is then repeated for the test result BCD counters, resulting in that data being converted to a decimal format and sent to printer 250.

The data entry system shown in FIG. 13 provides an interface between the Diclan 240 clinical analyzer and H1602 computer by utilizing the data flow to printer 250. The data being transmitted to printer 250 is in decimal form. The data entry system converts the decimal data to the BCD format so that only four data lines, rather than ten data lines, are required to go to the computer.

FIG. 14 shows an example of the signals transmitted to the computer by the data entry system of FIG. 13. For the purpose of this example, the sample accession number is 127 and the test result is 805. It can be seen that in addition to the sample accession number and the test result number three other types of signals are directed to the computer: the out-of-range" interrupt signal, the"data input interrupt signal, and the .data envelope" interrupt signal.

The out-of-range interrupt signal indicates that the test result is out of range and therefore inaccurate. This signal corresponds to thered overrange light on the Diclan and a special out-of-range printer format on printer 250. If the test result is out of range, out-ofrange alarm 252 sends an interrupt signal to the computer as shown in FIG. 14. This signal stays on as long as out-of-range samples are present. When a normal range sample appears, the out-of-range interrupt signal turns off.

Data input alarm 253 provides a data input interrupt signal. One signal is associated with the transfer of each BCD digit. The data input interrupt signal is derived from the transfer sequence signal from the printer and the gate pulses. Since both of these signals contain pulses other than the required alarm pulses, the desired data input alarm signal is derived by differentiating the sequence signal and then ANDing the result with the gate pulses.

Data envelope alarm 254 provides an interrupt signal at the beginning and the end of data transmission. The data envelope interrupt signals are derived from the Diclan timing cam.

It should be noted that the Diclan sample accession number is not utilized by the present patient-specimen identification system. This number may be discarded if desired by appropriate hardware or software modification.

MANUAL TEST STATION In FIG. 15 is shown a reader and data entry means for use when the sample analysis is performed manually. After the analysis has been performed, the analysis result is entered into the console 300 by pressing the appropriate buttons on keyboard 301. The analysis result is displayed on display 302' and is also stored in a buffer memory. After the analysis result is verified by visually checking display 302, read head 303 is pressed against the sub-sample label. Random number 2 is read and the analysis result and random number 1 are sent to memory 13.

DATA ENTRY In one embodiment of the present invention, the data entry means sends an interrupt signal to memory 13 and logic means 32. This interrupt signal indicates that data is about to be sent and that the pairs of random numbers should be stored in an associated manner in memory 13.

In the case of data entry from the transfer station and from the automated instrument, timing means 63 may provide the interrupt signal. The sequence of fourteen bits from the sense amplifiers is then sent to the memory by a line driver. Thus the fourteen bits from each label are entered into memory 13 as they are being read out.

In the case of the portable console, the random numbers x and y are read and stored in temporary memory 20 and later entered into memory 13. In this case, when connectionis made to data output terminal 103 on the portable console an interrupt signal is sent to memory 13 and logic means 32. The random numbers are then sequentially entered into memory 13. First one random number is entered and then the random number associated with that number is entered.

As a random number is received from one of the data entry means, logic means 32 performs a parity check using the two parity bits. If there are no parity errors and the data is properly stored, a data received" signal is sent to a data received flip flop located in the particular console which is sending the data. When the data received flip flop receives the data received pulse, it changes state and turns on data received indicator 114. This informs the technician or operator that the data has been received and the parity check found no error.

In a large patient-specimen identification system, there is a possibility that simultaneous interrupt signals may be sent to memory 13 from two different data entry means. This could result in erroneous information being stored. Another embodiment of the data entry means avoids this problem. In this preferred embodiment, each data entry means contains a small buffer memory to hold one or two sets of data. Logic means 32 and memory 13 cycle through the various data entry means every few seconds and interrogate each one as to whether it has data available. If a particular data entry means has data to be stored, a short time of exclusive use of logic and memory is allotted to that particular data entry means for dumping the data stored in the buffer memory into memory 13. In addition to eliminating a simultaneous interrupt problem, this preferred embodiment results in tighter control of the data and less chance of introducing spurious (noise) signals into memory 13. I

ASSOCIATION AND CORRELATION Although a variety of correlation techniques may be used with the present invention, one particularly advantageous correlation technique uses the computer instruction known as indirect addressing. With normal or direct addressing, the desired operation is performed on the contents of the address portion of the instruction. For example, LDA 20145 means load into the A register of the computer the contents of memory address 20145". With indirect addressing, which is signified by setting a designated bit in the instruction word, the command is modified to mean load into the A register the contents of the address which is in turn the contents of memory location 20145. The correlation technique can best be understood by reference to the following example.

When a patient 10 enters the hospital, random number x which appears on label 12 and the patients identity are entered into memory 13 by first data .entry means 14. Random number x is transformed into an address by adding address sector location A to random number 2:. Address sector location A is the first location in address sector No. 1. The patients identity is then stored in location A+x, as shown in FIG. 16.

When a sample is taken from the patient, random number x from the patients wrist label and random number y from the sample container label 16 are temporarily stored in an associated manner in temporary portable memory 20. Random number x and random number y are later transferred from temporary memory 20 to memory 13 by data entry means 21. Random number y is transformed into an address by adding address sector location B to it. Address sector location B is the first location in address sector No. 2. A+x is then stored in location B+y. It should be noted that since the addresses in address sector No. 2 correspond to the random numbers from the sample container labels, address sector No. 2 must be of a size equal to the number of sample container labels in the system, regardless of how many labels are actually being used on a given day.

When the sample is transferred to sub-sample containers, random number y and random number 2 are read and entered into memory 13. Random number z from the sub-sample label is transformed into an ad dress by adding address sector location C to it. Address sector location C is the first location of address sector No. 3. As with address sector No. 2, address sector No. 3 must be as large as the total number of subsample labels in the system. An indirect address designation bit is then added to word B+y and the modified word is stored in location C+z. 7

When random number 2, arrives at memory 13 from fourth data entry means 31, the contents of location C+z are indirectly retrieved. Logic means 32 goes to location C+z and notes the contents. Since an indirect bit is included in the contents, logic means 32 goes into an indirect mode to address location B+y. Logic means 32 notes the contents of location B+y (A+x) and proceeds to location A+x. Logic means 32 takes the contents of location A+x (the patients identity) and stores it temporarily.

When the test result from the sub-sample arrives at memory 13, it is paired with the patients identity. This pairing may be in the form of a dual table-double word method as shown in address sector No. 4, or a direct address method, as shown in address sector No. 5, in which the patients identity is the address and the test results are the contents.

Once the patients identity and the test results are paired, they are typically printed out by printer 33. It may also be desirable to retain the paired information in memory 13 for future use. Sample number y and subsample number 2 are no longer needed once correlation has occurred. Address locations B+y and C+z may therefore be cleared so that the labels containing random numbers y and z may be reused. Similarly, when

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Classifications
U.S. Classification235/375, 116/279, 422/67, 40/324
International ClassificationG01N35/02, G01N33/48, B01L3/14, G06K7/08, G06F19/00, G07C9/00
Cooperative ClassificationB01L3/5453, G06K7/089, G07C9/00015, G06F19/366, G06F19/3487
European ClassificationG06F19/36C, G06F19/34P, B01L3/5453, G07C9/00B2, G06K7/08D