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Real time control procedures for monitoring SMAC analytical performance
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REAL TIME CONTROL PROCEDURES FOR MONITORING SMAC ANALYTICAL PERFORMANCE* G, B/~ltlltdtl:.Sl, G, E, MARTI~ItANA, C. ZUI,Pl and A. CAITF.t.t.I'i" I~tilut~ di Chimica Iiioh~gica,Universiiii Callolicil S. C'tlt~re,I:acl~lt;idi Medicinae Chirt~rgitl sede in Roilili, llilly {Ri'reh'i'd 2.'1.him' 191~1; hi rt,i,i,~edfi~r,I 13 Norember 1981; reci,ii'ed fi>r Imbliculioa 5 MaJ' 19821
Allslrlicl \Vilh the aid of il n~illiconlputcr on litw witk SMAC, a syslenl which ill,'inages aaalylic:d results h;ls been dcvelol'~edto it;roster dllla Io suilahle support (llt~ppy disk I and to process them. C,rnpliler programs lll'ovidepositiv# sample ideJIlific;ilion,gre;~llyincreiising instrulnertt software ¢onlrols, ,:llld perform it real time extertial qu~dity col~trol, thus l'~rmiiting SMAC analytical perft~riri;ince optimization. Ailltlrnlllic illinicolilptllel'
ilnlllyzer
Perh,rnlance optimization
Real lime qualily control
On-line
INTRODUCTION The SMAC, employed routinely in our clinical chemistry laboratory, is equipped with a built-in computerized system which controls the analytical process and manages test restllts atl |OllOlllOtlSiy. SlVlAC dala reports, being printed on paper, cannot be directly transferred as such to the hospilal Data Processing Center ( D P C k unless they have been previously transferred to a suitable supporl by lengthy and error-prone manual procedures, Furthcrnaore, during analytical runs a continuous surveillance is required by st<'dY concerned with the instrument error reporting system. Both aspects soon became a cumbersome task for the clerical and technical personnel. Having previously worked out the problems of the random management of samples and results by means of a triinicomputer equipped with an automatic optical reader [I], we turned our attention to the development e t a program aiding the follow-up offault reporting, surveyed by SMAC's own software, and at the same time making available to the stafffi~rther parameters for monitoring instrument performance. In particul,'tr, we introduced additional mathematical and alerting tests to yield results with ~ high error probability arid a real time quality control procedure in order to assess quantilatively each analytical channel reliability [2, 3]. MATERIALS
AND METHODS
t h o ' d w a r e (Fi~.l. I ). P6060 (lng. C. Oli.vetti & C. S.p.A., Ivrea, Italy). 32 kbyte R O M minicomputer, 400 kbyte RAM on two floppy disks, equipped with IPSO interface for Olivetti Standard peripherals and E1A interface for 'current loop' Or 'lnode~rf type output analyzers. O P R 1830 Warrd (Ing. C, Olivetti & C. S.p.A., Ivrea, Italy). Automatic optical reader for O C R - B characters.
* This work was supported by C.N.R. re.~arch grant No. 80.02256.83,as part of the finalized project 'Prevenlive Medicine'. subproject 'Methods for Aulomalic Data Man:lgement and Medical Record Processing. "t"Address for correspondence: A. Castelli, lstituto di Chimica Biologica--Universil~i Caltolica S. Cuore--Via Pinela Sacchetti. 64,1,00168 Roma, Italy. 7
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Fig. I. Hardware contiguration.
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PR 1230 (Ing. C. Olivetti characters/s printer. SMAC (Technicon Inc., Tarrytown, NY, U.S.A.). Equipped with RS-232 interface. S~w~lre. Programs in Basic were studied and developed in our laboratory. Control sera. TQC: Technicon quality control (Technicon Inc., Tarrytown, NY, U.S.A.I. ON and OA: Ortho Normal and Ortho Abnormal unassayed .~ra. {Ortho Diagnostics Inc., Raritan, NY, U.S.A.) PN and PP; Precinorm U and Precipath U (Boehringer Biochemia Robin, Mannheim, F.R.G.).
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Real time co111rol procedures ff~r monitoring SMAC mmlylical performance 0
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idenlilic;,tion. 0 = batch sequence number; • = patient number; [] = SMAC sampling position number; am = SMAC reporl number. SYSTEM
DESCRIPTION
Sample identification Samples intended for SMAC come to the Laboratory and are easily recognized by their blue cap (Lithium-Heparin). They are divided into 50-150 specimen batches and are analyzed soon after centrifugation in a completely randomized manner. Patient numbers on each sample tag have been preprinted in OCR-B characters with, at the beginning, a letter 'T' defining an optical field of 6 digits, which can either be stored automatically by the OPR 1830 Wand reader or manually entered without any delay by keyboard when anything disturbs the automatic process. Possible input errors are checked by program ; in particular, input repetition is displayed and prevented, and lield numerical character and length are constantly checked (Fig. 2). With the same input procedure, sample sequence, SMAC rack position and data report output succession numbers are defined (Fig. 3). Any plasma specimen is now identified by four numbers: batch and sampling positions, report and patient numbers, which greatly help the technical staff in control operations and sample manipulation.
On-line.fetltures SMAC on-line connection to the minicomputer is of the free-running modem type and a program-defined circular buffer is used for data acquisition. Data report is built by 327 characters exchanged at 300 baud rate, by which transaction time is one third of analytical time. Each character is coded by 7 bits, even parity control, plus 1 bit for start and 1 bit for stop. SMAC report output consists of four data lines and of two carriage returns dividing each output from the next [4].
Analytica! result acquisition and control (Fig. 4) The tirst two data lines, addressed to contain census data which should have been manually entered through the SMAC key-board, are ignored by the P6060 minicomputer, while the last two lines are processed to get report number and analytical values. Report number is accepted only when it shows a unit increase from the previous one. Each result field (Table 1 ) is checked for errors (Table 2). The program is able to decipher the type of error, which the minicomputer prints out immediately for operator attention. Uncorrectable errors are pointed out at the right-hand border of the printer roll, implying the automatic cancellation of results. Errors printed on the left-hand side are referred to the operator. In addition to built-in SMAC controls, result values with a high possibility of being erroneous are checked out by a
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program with two different types oftest, the former ofthe mathematical, the latter of the alert kind (Fig. 5). Electrolyte balance evaluation is an example of the first kind of test: when a difference of more than 4 mEq/I is formed between the sums of the anions and cations, an index of probable ion unbalance is shown to the operator together with all the results pertaining to it. The same kind ofcheck is taken into account when it is possible to establish a mathematical relationship regarding a pair of interconnected chemical parameters such as bun-creatinine, G O T - G P T , total protein-albumin. Finally, the alert test ensures that abnormal values, although within the range of method linearity, do not go unnoticed. Every decision in the above-mentioned cases depends upon operator professional skill and judgement.
Real lime control procedures for mottitoring SNIAC llnalytical perfornltint'¢
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"l';ible I. Accepted range values fi~r SMAC analytical tests Test name
I-"ield
Glucose ({iluc} Urea nitrogen (Ikm) "Fo1;41protein (TP) Albumin {Alb) Sodium {Na) l>otas,siunt{KI Calcitma 1(Ta) Chloride (Cll Pllospltorus I P} Cre;liitline (Cre,'tI Uric acid (Uric) Total bilirubin (Tltill Alkaline'phosphat;i.~ (AIk P) Transaminase GO (GOT) Trans,'ilninilse G P (G P'F} Cholesterol (Choll
Range of accepted values
I "~ 3 4 5 6 7 8 9 I0 I1 12 13 t4 15
16
30-300 mg/dl 3-80 mgAII 4.0-9.0 g/dl 2.0-5.0 g/dl 128-155 mEq/l 3.0-5.5 mEq/I 7.0-12.0 rag/el 95-115 mEq/I 1.5-.5.5 mg/dl 0.3-4.0 mg/dl 2.0- I 0.0 mg/dl 0.1-7.0 mg/dl 35-15(I rnU/nll 3-300 mU/ml 2-300 mOiml 1(10-4(KImg/dl
Red time qmdity cotm'ol Five sera with differing target vahtes of c o m p o u n d concentrations are employed in S M A C quality control schedule. The sera are distributed along sample batches in fixed positions previously memorized by an internal file. The following pattern is strictly followed: three control sera (TQC, PN, PP) are positioned soon after the S M A C initial calibration and before any subsequent a u t o m a t i c recalibration levery 48 s,'maples), while the other two sera (ON and OA) are alternately placed every 16 samples. The nainicomputer receives on-line from SMAC control sera analytical data, identifies serum type from its batch position, prints the corresponding results and calculates a reliability index (RI) for each chemical method (Fig. 6). This numerical value corresponds to the standardized normal deviate [5] so obtained: Xi - ,¥ . 1130 = RI SD where X; = experimental value ; X = expected correct value : SD = standard deviation. The ratio is multiplied by 100 to avoid decimal points. The correct value is the target value for accuracy index calculation or the mean value found for unassayed sera (ON, OA) for the precision index ; the s t a n d a r d deviation is calculated for each method from previous runs under carefully controlled conditions. The correct and SD values, stored on a updatable file, are loaded on a matrix of 10 columns (:,? and SD for five sera) and 16 lines (I 6 tests for each serum) to reduce time of calculation routine. All daily results are also stored in a file for retrospective m o n t h l y processing. During the last operation, all sera results and indexes obtained for each chemical parameter on that d a y are tabulated. Before this definitive storage procedure, outliers can be purged from the file.
Table 2. SMAC error reporting T D /3
G L C
Turbidity and/or depletion Reagent depleted or test results arc non linear Blank value is higher titan assay value Over range condition Sample rejected because of questionable curve quality Too-close-to-baseline condition Excessive carry-over condition possible
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DISCUSSION The reported program is not limited to an on-line computerized management of SMAC analytical dat,'l, employing ,'l floppy disk which facilitates further processing (reports, data bank, statistics and clinical evaluation), but also achieves a very necessary and accurate monitoring of an,'tlyzer performance. In fact, error reportings by the instrument's own software are recalled and brought to the attention of the operator, who is otherwise obliged to make a time-consuming inspection of each report. Moreover, additional data control routines (mathematical and alert tests)indicate clearly results with a high probability of not being wtlid. In any cam, the final decision on what to do retnains with the operator. In fact we have not introduced rigid rules for we do not support the idea of a full)' automatized laboratory with no room for human intervention [6], while our experience suggests that it correct evalttation of results largely depends upon the staff's professional judgen'lent and practical skill [7]. With this view of personal responsibility we also decided to keep the instrutnent performance under constant control by means of a suitable statistical paratneter, released in real tithe, as a further tool for quick and easy interpretation of result reliability. Finally, the awtilability of summary reports and monthly control charts permits a complete and accurate statistical analysis, monitors the instrument's general performance in titne and suggests possible corrections. This S MAC-minicomputer on-line program has proved to be very vahtable over more than two years and has been fully accepted by technical staff who, without an informative background, soon appreciated its real help for management simplification and analytical performance optimization. L,'tstly, the low cost of the hardware tless than 10'X, of SMAC) is fully recovered by reduction in instrument hours and by a marked reduction in the nutnber of clerical and technical personnel. We recommend this practical and cheap system to other laboratories for tlaetr consideration.
SUMMARY A system has been developed in our Hospital Clinical Chemistry Laboratory with the aid of a minicomputer on line with SMAC. The programs are in Basic and comprise management of patient samples and of reference sera, on-line acquisition of analytical data, checks of error reporting and of abnormal result values, real time processing of quality control parameters and data transfer on floppy disk. An efficient and easy monitoring of the chemical procedures and result reliability is achieved together with instrument performance optimization.
REFERENCES 1. G. Barbaresi, G. E. Martorana, C. Zuppi and A. Castelli, Sample and data random management in a medical laboratory equipped with automatic analyzers. (Submitted for publication). 2. G. Giocoli, M. L. Gozzo, G. Barbaresi and G. Miggiano, Utilizzazione della deviata standardizzata per il controllo di qualitfi dello SMAC in tempo reale, G. iral. Chim. Clin. (accepted for publication). 3. P. E. Undrill, R. E. :Stroud and N. Paterson, Incorporation e t a SMAC analyzer into the data-processing procedures of a computer-assisted laboratory, Clin. Chem. 25, 466-469 (1979). 4. Laboratory Information System (LIS) interface, Tecbnicon Information Bulletin No. TN4-0320-20 (1978). 5. P. Armitage, Statistical Method.~ in Medical Research. Black.well Scientific, Oxford (1971). 6. R. S. Melville, Dials. meters and gadgets, Lab. Mgmt, 16-18 (1972). 7. W. F. Hamilton and S. Raymond ECLIPS: an extended clinical laboratory information processing system, Comput. Biol. Med. 3, 3-12 (1973).
Real time conlrol procedures Ibr mt~uiloring SMAC analylical performtmce Almut tile Aulhor--.G II q.lA,x()ll altlU~,rlsl w,'ls h()ru in I:ano (llaly) on 15 ,~plember 1936, I le received a Ph.I). degree ill chemislry from Iioh)gna Universily in 1963. From 1966 he became ilssisianl ill Ihe Biok)gical Chemislry Inslilule of Ihe Calholic University, and now he is Assochlle l'rofes:,or of Ihe Clinical Chemislry imboralory of Policlinico Gemelli, R()me. I lis re~;ircll aciivilies, aparl [r()m problems or lipid lllel;iholisnl ;.ind enzymotogy, center around programs of compulerizalion, lie developed systems for iltllom~.ltic laboratory nmnagenlent and fl~r ;malylical data processing. Since t978 he has been working on lilt: CNR finalized project 'Prevenlive Medicine', subprojecl 'Methods for Aulonl;lliC l)ala M;magemenl und Medical Record Processing'. Almul Ihe Author:--G I~.'.;1~1,1,1E IItIRt: M .I lll I)II.INAreceived tile M.D. degree fftm~ C'atholic University (Rome} in 1971 and has heen assislanI Io the Inslilule of Bioh~gical Chemislry since lhen. I le w~rks in tile lield of enzyme kinetics and is currenlly inleresled in problems tff computer assisted instrumenlalion, lie hus also been working since 1978 on the Ilalian CNR suhprojecI 'Melhods fi~r Autonlalic I)11111Management lind Medic;,l Record Processing' of lhe project "Preventive Medicine'. ..t.bOlflthe A u l h o r - C I CII.IAZI'I'I'I W~.lSborll in Rome (Italy)on 3 June 1949. Size recmived M.i). degree from the Catholic University in 1973. Since 1974 she is assist:rot at tile Biological Chemislry Inslitute of Catholic University (Rome). She is working on lhe finalized projecl of CNR (Italy) "Prevenlive Medicine" subprt~jeel "Methods for Atltolnatic I)i|111 Managemenl and Medical Record Processing'. Ahou! tile Aulhor--Al~rlANoCASll~l.I I was horn in Massa Lomh;,rda (Ravenna) oll 25 AtlgusI 1929. I le received tile M.I). degree frown Bologna Universily in 1955. I le was an assistanl al Ihe Inslilule of Biological Chemislry of Bologn:l University from 1956 to 196~ when he became Associate Professor of Ilit~logicul Chemistry. In 1971) he became Professor and Direclor of the InslilUle of Biological Chemistry al the Catholic Universily, Rome. Since 1970 he has also been he;,d of tile Clinical Chemistry Laboratory of the Policlinico A. Gemelli, U.C.S.C., Rome, where he inlroduced aulomaled instrumentation and informative systems, lie is responsible for tile subprojecl "Melhods for Atltomalic Data Management and Medical Record Processing'. par1 of tile projecl "Preventive Medicine' of tile Italian C.N.R.
15
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REAL TIME CONTROL PROCEDURES FOR MONITORING SMAC ANALYTICAL PERFORMANCE* G, B/~ltlltdtl:.Sl, G, E, MARTI~ItANA, C. ZUI,Pl and A. CAITF.t.t.I'i" I~tilut~ di Chimica Iiioh~gica,Universiiii Callolicil S. C'tlt~re,I:acl~lt;idi Medicinae Chirt~rgitl sede in Roilili, llilly {Ri'reh'i'd 2.'1.him' 191~1; hi rt,i,i,~edfi~r,I 13 Norember 1981; reci,ii'ed fi>r Imbliculioa 5 MaJ' 19821
Allslrlicl \Vilh the aid of il n~illiconlputcr on litw witk SMAC, a syslenl which ill,'inages aaalylic:d results h;ls been dcvelol'~edto it;roster dllla Io suilahle support (llt~ppy disk I and to process them. C,rnpliler programs lll'ovidepositiv# sample ideJIlific;ilion,gre;~llyincreiising instrulnertt software ¢onlrols, ,:llld perform it real time extertial qu~dity col~trol, thus l'~rmiiting SMAC analytical perft~riri;ince optimization. Ailltlrnlllic illinicolilptllel'
ilnlllyzer
Perh,rnlance optimization
Real lime qualily control
On-line
INTRODUCTION The SMAC, employed routinely in our clinical chemistry laboratory, is equipped with a built-in computerized system which controls the analytical process and manages test restllts atl |OllOlllOtlSiy. SlVlAC dala reports, being printed on paper, cannot be directly transferred as such to the hospilal Data Processing Center ( D P C k unless they have been previously transferred to a suitable supporl by lengthy and error-prone manual procedures, Furthcrnaore, during analytical runs a continuous surveillance is required by st<'dY concerned with the instrument error reporting system. Both aspects soon became a cumbersome task for the clerical and technical personnel. Having previously worked out the problems of the random management of samples and results by means of a triinicomputer equipped with an automatic optical reader [I], we turned our attention to the development e t a program aiding the follow-up offault reporting, surveyed by SMAC's own software, and at the same time making available to the stafffi~rther parameters for monitoring instrument performance. In particul,'tr, we introduced additional mathematical and alerting tests to yield results with ~ high error probability arid a real time quality control procedure in order to assess quantilatively each analytical channel reliability [2, 3]. MATERIALS
AND METHODS
t h o ' d w a r e (Fi~.l. I ). P6060 (lng. C. Oli.vetti & C. S.p.A., Ivrea, Italy). 32 kbyte R O M minicomputer, 400 kbyte RAM on two floppy disks, equipped with IPSO interface for Olivetti Standard peripherals and E1A interface for 'current loop' Or 'lnode~rf type output analyzers. O P R 1830 Warrd (Ing. C, Olivetti & C. S.p.A., Ivrea, Italy). Automatic optical reader for O C R - B characters.
* This work was supported by C.N.R. re.~arch grant No. 80.02256.83,as part of the finalized project 'Prevenlive Medicine'. subproject 'Methods for Aulomalic Data Man:lgement and Medical Record Processing. "t"Address for correspondence: A. Castelli, lstituto di Chimica Biologica--Universil~i Caltolica S. Cuore--Via Pinela Sacchetti. 64,1,00168 Roma, Italy. 7
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Fig. I. Hardware contiguration.
&C.S.p.A.,lvrea,Italy).130
PR 1230 (Ing. C. Olivetti characters/s printer. SMAC (Technicon Inc., Tarrytown, NY, U.S.A.). Equipped with RS-232 interface. S~w~lre. Programs in Basic were studied and developed in our laboratory. Control sera. TQC: Technicon quality control (Technicon Inc., Tarrytown, NY, U.S.A.I. ON and OA: Ortho Normal and Ortho Abnormal unassayed .~ra. {Ortho Diagnostics Inc., Raritan, NY, U.S.A.) PN and PP; Precinorm U and Precipath U (Boehringer Biochemia Robin, Mannheim, F.R.G.).
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Keyboard Input
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Yes Fig. 2. Patient number input.
Real time co111rol procedures ff~r monitoring SMAC mmlylical performance 0
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idenlilic;,tion. 0 = batch sequence number; • = patient number; [] = SMAC sampling position number; am = SMAC reporl number. SYSTEM
DESCRIPTION
Sample identification Samples intended for SMAC come to the Laboratory and are easily recognized by their blue cap (Lithium-Heparin). They are divided into 50-150 specimen batches and are analyzed soon after centrifugation in a completely randomized manner. Patient numbers on each sample tag have been preprinted in OCR-B characters with, at the beginning, a letter 'T' defining an optical field of 6 digits, which can either be stored automatically by the OPR 1830 Wand reader or manually entered without any delay by keyboard when anything disturbs the automatic process. Possible input errors are checked by program ; in particular, input repetition is displayed and prevented, and lield numerical character and length are constantly checked (Fig. 2). With the same input procedure, sample sequence, SMAC rack position and data report output succession numbers are defined (Fig. 3). Any plasma specimen is now identified by four numbers: batch and sampling positions, report and patient numbers, which greatly help the technical staff in control operations and sample manipulation.
On-line.fetltures SMAC on-line connection to the minicomputer is of the free-running modem type and a program-defined circular buffer is used for data acquisition. Data report is built by 327 characters exchanged at 300 baud rate, by which transaction time is one third of analytical time. Each character is coded by 7 bits, even parity control, plus 1 bit for start and 1 bit for stop. SMAC report output consists of four data lines and of two carriage returns dividing each output from the next [4].
Analytica! result acquisition and control (Fig. 4) The tirst two data lines, addressed to contain census data which should have been manually entered through the SMAC key-board, are ignored by the P6060 minicomputer, while the last two lines are processed to get report number and analytical values. Report number is accepted only when it shows a unit increase from the previous one. Each result field (Table 1 ) is checked for errors (Table 2). The program is able to decipher the type of error, which the minicomputer prints out immediately for operator attention. Uncorrectable errors are pointed out at the right-hand border of the printer roll, implying the automatic cancellation of results. Errors printed on the left-hand side are referred to the operator. In addition to built-in SMAC controls, result values with a high possibility of being erroneous are checked out by a
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program with two different types oftest, the former ofthe mathematical, the latter of the alert kind (Fig. 5). Electrolyte balance evaluation is an example of the first kind of test: when a difference of more than 4 mEq/I is formed between the sums of the anions and cations, an index of probable ion unbalance is shown to the operator together with all the results pertaining to it. The same kind ofcheck is taken into account when it is possible to establish a mathematical relationship regarding a pair of interconnected chemical parameters such as bun-creatinine, G O T - G P T , total protein-albumin. Finally, the alert test ensures that abnormal values, although within the range of method linearity, do not go unnoticed. Every decision in the above-mentioned cases depends upon operator professional skill and judgement.
Real lime control procedures for mottitoring SNIAC llnalytical perfornltint'¢
I1
"l';ible I. Accepted range values fi~r SMAC analytical tests Test name
I-"ield
Glucose ({iluc} Urea nitrogen (Ikm) "Fo1;41protein (TP) Albumin {Alb) Sodium {Na) l>otas,siunt{KI Calcitma 1(Ta) Chloride (Cll Pllospltorus I P} Cre;liitline (Cre,'tI Uric acid (Uric) Total bilirubin (Tltill Alkaline'phosphat;i.~ (AIk P) Transaminase GO (GOT) Trans,'ilninilse G P (G P'F} Cholesterol (Choll
Range of accepted values
I "~ 3 4 5 6 7 8 9 I0 I1 12 13 t4 15
16
30-300 mg/dl 3-80 mgAII 4.0-9.0 g/dl 2.0-5.0 g/dl 128-155 mEq/l 3.0-5.5 mEq/I 7.0-12.0 rag/el 95-115 mEq/I 1.5-.5.5 mg/dl 0.3-4.0 mg/dl 2.0- I 0.0 mg/dl 0.1-7.0 mg/dl 35-15(I rnU/nll 3-300 mU/ml 2-300 mOiml 1(10-4(KImg/dl
Red time qmdity cotm'ol Five sera with differing target vahtes of c o m p o u n d concentrations are employed in S M A C quality control schedule. The sera are distributed along sample batches in fixed positions previously memorized by an internal file. The following pattern is strictly followed: three control sera (TQC, PN, PP) are positioned soon after the S M A C initial calibration and before any subsequent a u t o m a t i c recalibration levery 48 s,'maples), while the other two sera (ON and OA) are alternately placed every 16 samples. The nainicomputer receives on-line from SMAC control sera analytical data, identifies serum type from its batch position, prints the corresponding results and calculates a reliability index (RI) for each chemical method (Fig. 6). This numerical value corresponds to the standardized normal deviate [5] so obtained: Xi - ,¥ . 1130 = RI SD where X; = experimental value ; X = expected correct value : SD = standard deviation. The ratio is multiplied by 100 to avoid decimal points. The correct value is the target value for accuracy index calculation or the mean value found for unassayed sera (ON, OA) for the precision index ; the s t a n d a r d deviation is calculated for each method from previous runs under carefully controlled conditions. The correct and SD values, stored on a updatable file, are loaded on a matrix of 10 columns (:,? and SD for five sera) and 16 lines (I 6 tests for each serum) to reduce time of calculation routine. All daily results are also stored in a file for retrospective m o n t h l y processing. During the last operation, all sera results and indexes obtained for each chemical parameter on that d a y are tabulated. Before this definitive storage procedure, outliers can be purged from the file.
Table 2. SMAC error reporting T D /3
G L C
Turbidity and/or depletion Reagent depleted or test results arc non linear Blank value is higher titan assay value Over range condition Sample rejected because of questionable curve quality Too-close-to-baseline condition Excessive carry-over condition possible
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G. IIARIIAItI~il,G, E. M,'HIIlIRAN,'~C, ZtlI'I'I and A. CASll I.I l
DISCUSSION The reported program is not limited to an on-line computerized management of SMAC analytical dat,'l, employing ,'l floppy disk which facilitates further processing (reports, data bank, statistics and clinical evaluation), but also achieves a very necessary and accurate monitoring of an,'tlyzer performance. In fact, error reportings by the instrument's own software are recalled and brought to the attention of the operator, who is otherwise obliged to make a time-consuming inspection of each report. Moreover, additional data control routines (mathematical and alert tests)indicate clearly results with a high probability of not being wtlid. In any cam, the final decision on what to do retnains with the operator. In fact we have not introduced rigid rules for we do not support the idea of a full)' automatized laboratory with no room for human intervention [6], while our experience suggests that it correct evalttation of results largely depends upon the staff's professional judgen'lent and practical skill [7]. With this view of personal responsibility we also decided to keep the instrutnent performance under constant control by means of a suitable statistical paratneter, released in real tithe, as a further tool for quick and easy interpretation of result reliability. Finally, the awtilability of summary reports and monthly control charts permits a complete and accurate statistical analysis, monitors the instrument's general performance in titne and suggests possible corrections. This S MAC-minicomputer on-line program has proved to be very vahtable over more than two years and has been fully accepted by technical staff who, without an informative background, soon appreciated its real help for management simplification and analytical performance optimization. L,'tstly, the low cost of the hardware tless than 10'X, of SMAC) is fully recovered by reduction in instrument hours and by a marked reduction in the nutnber of clerical and technical personnel. We recommend this practical and cheap system to other laboratories for tlaetr consideration.
SUMMARY A system has been developed in our Hospital Clinical Chemistry Laboratory with the aid of a minicomputer on line with SMAC. The programs are in Basic and comprise management of patient samples and of reference sera, on-line acquisition of analytical data, checks of error reporting and of abnormal result values, real time processing of quality control parameters and data transfer on floppy disk. An efficient and easy monitoring of the chemical procedures and result reliability is achieved together with instrument performance optimization.
REFERENCES 1. G. Barbaresi, G. E. Martorana, C. Zuppi and A. Castelli, Sample and data random management in a medical laboratory equipped with automatic analyzers. (Submitted for publication). 2. G. Giocoli, M. L. Gozzo, G. Barbaresi and G. Miggiano, Utilizzazione della deviata standardizzata per il controllo di qualitfi dello SMAC in tempo reale, G. iral. Chim. Clin. (accepted for publication). 3. P. E. Undrill, R. E. :Stroud and N. Paterson, Incorporation e t a SMAC analyzer into the data-processing procedures of a computer-assisted laboratory, Clin. Chem. 25, 466-469 (1979). 4. Laboratory Information System (LIS) interface, Tecbnicon Information Bulletin No. TN4-0320-20 (1978). 5. P. Armitage, Statistical Method.~ in Medical Research. Black.well Scientific, Oxford (1971). 6. R. S. Melville, Dials. meters and gadgets, Lab. Mgmt, 16-18 (1972). 7. W. F. Hamilton and S. Raymond ECLIPS: an extended clinical laboratory information processing system, Comput. Biol. Med. 3, 3-12 (1973).
Real time conlrol procedures Ibr mt~uiloring SMAC analylical performtmce Almut tile Aulhor--.G II q.lA,x()ll altlU~,rlsl w,'ls h()ru in I:ano (llaly) on 15 ,~plember 1936, I le received a Ph.I). degree ill chemislry from Iioh)gna Universily in 1963. From 1966 he became ilssisianl ill Ihe Biok)gical Chemislry Inslilule of Ihe Calholic University, and now he is Assochlle l'rofes:,or of Ihe Clinical Chemislry imboralory of Policlinico Gemelli, R()me. I lis re~;ircll aciivilies, aparl [r()m problems or lipid lllel;iholisnl ;.ind enzymotogy, center around programs of compulerizalion, lie developed systems for iltllom~.ltic laboratory nmnagenlent and fl~r ;malylical data processing. Since t978 he has been working on lilt: CNR finalized project 'Prevenlive Medicine', subprojecl 'Methods for Aulonl;lliC l)ala M;magemenl und Medical Record Processing'. Almul Ihe Author:--G I~.'.;1~1,1,1E IItIRt: M .I lll I)II.INAreceived tile M.D. degree fftm~ C'atholic University (Rome} in 1971 and has heen assislanI Io the Inslilule of Bioh~gical Chemislry since lhen. I le w~rks in tile lield of enzyme kinetics and is currenlly inleresled in problems tff computer assisted instrumenlalion, lie hus also been working since 1978 on the Ilalian CNR suhprojecI 'Melhods fi~r Autonlalic I)11111Management lind Medic;,l Record Processing' of lhe project "Preventive Medicine'. ..t.bOlflthe A u l h o r - C I CII.IAZI'I'I'I W~.lSborll in Rome (Italy)on 3 June 1949. Size recmived M.i). degree from the Catholic University in 1973. Since 1974 she is assist:rot at tile Biological Chemislry Inslitute of Catholic University (Rome). She is working on lhe finalized projecl of CNR (Italy) "Prevenlive Medicine" subprt~jeel "Methods for Atltolnatic I)i|111 Managemenl and Medical Record Processing'. Ahou! tile Aulhor--Al~rlANoCASll~l.I I was horn in Massa Lomh;,rda (Ravenna) oll 25 AtlgusI 1929. I le received tile M.I). degree frown Bologna Universily in 1955. I le was an assistanl al Ihe Inslilule of Biological Chemislry of Bologn:l University from 1956 to 196~ when he became Associate Professor of Ilit~logicul Chemistry. In 1971) he became Professor and Direclor of the InslilUle of Biological Chemistry al the Catholic Universily, Rome. Since 1970 he has also been he;,d of tile Clinical Chemistry Laboratory of the Policlinico A. Gemelli, U.C.S.C., Rome, where he inlroduced aulomaled instrumentation and informative systems, lie is responsible for tile subprojecl "Melhods for Atltomalic Data Management and Medical Record Processing'. par1 of tile projecl "Preventive Medicine' of tile Italian C.N.R.
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