Sample and data random management

(1)

in

a

medical

laboratory

equipped

with

automatic

analysers

G. Barbaresi,

G. E.

Martorana,

C. Zuppi and

A. Castelli

Istituto diChimicaBiologica, Universit CattolicaS.Cuore, Facolti di Medicinae Chirurgia, Viadella PinetaSacchetti664,

00168 Rome,Italy

Introduction

Recent advancesintheperformanceof automaticanalysers and

in computer technology, although both share the aim of

increasing speed, ease and operational capacity, have

para-doxically led to astalemate inmanyclinical laboratories.The

new autoanalysers equipped with computers are capable of

coping with a large analytical load, but often they can only

partly cope with the data management process and so they

increase laboratory tasks. Further, many hospital data

pro-cessing centres(DPCs),copyingtheiroldmanualproceduresare limited to clericalwork,which isagreat pity consideringtheir enormouscomputing powers [-1].

Laboratories often find that their advanced instrument

analytical capabilityis conditionedbytwobottlenecks: manual

inputoftestrequestsand memorizationofclinicalresults[2-1.

Sinceacentraldata-bankisnecessary forthecompleteclinical and statistical use of laboratory data in a large university

hospital [-3-],acomputerizedsystem has beendevelopedinthe

authors’clinical chemistrylaboratorywhich isconnectedtothe

DPC bymeansoffloppydisc informationtransfer. The system

allows positive sample identification by anautomatic optical

reader and,togetherwith on-lineanalyticalresultacquisition,it

ispossibletoprocess patient specimensatrandomastheyarrive

in the laboratory. This feature means that the delays and

difficulties encountered with an exclusively centralized

managementare avoided.

Materials

and

methods

Hardware

TheDPCintheauthors’teaching hospitalisequipped withan

IBMsystem, which is usedforgeneral accounting and, bymeans ofterminals and printers, for the admission office and other centralized servicesand laboratories.The authors’laboratory

usestheDPCasadata-bank(itmemorizespatient requests and

results, prints-out worksheets and clinicalreports).

The central system (seefigure 1) consists of the following

instruments:

IBM 370/138 (CPU [1 Mbyte memory]).

IBM 3340 (data-bank).

IBM 3344 (discunit).

IBM 3741 (recordingunit).

IBM 3287 (printingterminal).

IBM 2741 (printing terminal with

characters).

IBM 1403 (printer).

IBM 3747 (disc-tapeconversion unit).

OCR-B

The laboratory system is based on a minicomputer (the

P6060:Ing. C.Olivetti&C.

S.p.A.,

Ivrea,Italy),witha32-Kbyte

ROMand 400KbyteRAMinfloppydiscs,equippedwithtwo interfaces for Olivetti standard peripherals and for analytical

instruments.The system comprises the following: Olivetti 6602 Olivetti 2132 Olivetti 6600 Olivetti Olivetti EIA SMAC CLINICAB PR 1230 OPR1830 wand (CPU). (ROM).

(IPSOstandardOlivettiperipheral

interface).

(printer [130 characters/s-I).

(automatic opticalreader for

OCR-B characters).

(seriesinterface for on-line’modem’

and/or

’current loop’ connection

withinstruments).

(supplied by Technicon Inc.,

Tarrytown, New York, USA--a

sequential multichannel analyser

computerized for serum and

plasmasamples).

(supplied bytheAMES Company,

Division Miles Laboratory Inc.,

Elkhart, Indiana, USA, an

auto-mated urinalysis system).

Software

Programs for the P 6060 and connected peripherals are in

BASIC and were written bylaboratory staff. IBM programs

mentionedin thispaperweresuggested by the authors and then

writtenby DPC personnel.

System

description

Sample

_flow

When the patients’ samples arriveinthe laboratory,theyare

pretaggedin OCR-Bcharacters.These tagsare automatically

producedwhenapatientisadmitted to thehospital and theyare

sent to thewards togetherwith the clinicalreport. Sarhplesfor automatic instruments areeasily recognizable: theircontainer

hasacoloured cap; theyareanalysedquicklyinacompletely

random manner. The results, sequentially furnished by the

analyseron-line to theminicomputer, are associated with the

sequence ofthepatient numbers printedontagswhich areread

by the OPR 1830wand (seefigure2). Inthisway a ’result file’

composed ofmany records is automatic,ally generated; each

recordismadeupofanalytical data and of patientidentification

(ID)numbers.

0142 0453/82/04040169$05’00

(2)

Request

input

3741

1403

Local

systems

SMAC

Clinilab

bank

CPU

370/158

R T

dinal

term

2741

P’6060

PR

1230

)

N

f

₂₈₇

₎

Patient

sample

(3)

On-line results

record

J

Sample

in

QPR

or

eyboerd

inp Validation routines

Integrative

procedures

Result

file

Figure 2. Result-sample linkage.

System efficiency depends upon the analytical and ID

sequence,so avalidationroutine isalso included.Ifautomatic

optical reading is not possible (as a result of blood spots,

misprinting etc.), then manual input by keyboard, used as a

remote peripheral,is allowed.

and sent directly to theDPC,wheretheyarestored, processed,

sequenced and, finally, printed on traditional worksheets,

disregarding test codes which require automatic instrument

analysis(seetable 1).Fortheselatter requests,asequential file,

made upof 128byte records,isgeneratedonfloppydisc. The

first32bytesofeachrecordarereserved for the memorization of

the patients’numbers(six bytes), oftheward codes(twobytes)

and of the patients’names(24bytes).The following 68bytesare divided into 17fields, fourbytes long, which areflagged only

when the corresponding test codeisrequested.

Filedata arealsotabulated.

Table1. Analytical tests:code and

_field

number.

Test Code Field

Glucose Ureanitrogen 2 2 Total protein 3 3 Albumin 5 4 Sodium 6 5 Potassium 7 6 Calcium 17 7 Chloride 20 8 Phosphorus 19 9 Creatinine 14 10 Uricacid 15 11 Totalbilirubin 11 12 Alkalinephosphatase 10 13 GOT 8 14 GPT 9 15 Cholesterol 16 16 Urinalysis 29 17

Result-request linkage

(see

figure

3)

SMAC analytical results

SMAC data records are logically set in numerical order by

patient number and matched with request records; only

re-questedresultsarestored. Itispossibletomanuallyenterthose

results which, because of momentary instrument failure,sample

turbidity, out ofrangevalues andcarry-over,forexample,were

notcorrectly supplied bytheSMAC,orwhichwereconsidered

unreliablebyareal-timequality control program [4]. At the end of the linkage procedure, patients’ numbers without requests and their related results are automatically listed.Similarly, outstandingrequestsareprintedout.Finally,

pathologicalresultsofnon-requested parametersarereportedin

aprintedlist.

CLINILABurinalysis results

CLINILAB data records generate worksheets for sediment

microscopy and for glucose and protein quantitative assays

following analysed sample sequence (seefigure 4). Up to five

parameters for each sample are provided in the microscope

examinationworksheet.Eachparameterisidentifiedbya

three-digitnumber:twofor the kind and one for thequantity.Inthe

work-list forglucose and protein quantitative assay onlythose

samples with abnormal qualitative results are printed, each

urinespecimen beingidentifiedbythepatientnumber andbythe

CLINILABsequence number.

Analyticalresultscanbeenteredbykeyboard, by worksheet

orbothandinput accuracyiscontrolledbyavalidation routine.

Urinechemistry and microscopyresults arestoredon a

(4)

DPC

P6060

Request

file

Result

file

Request

record

Patient

number

Result

record

Patient

number

Smaller

number of

No

The

No

requests

same

number

Smaller number of

requests

Outstanding

request

Yes

Requestless

No

Result noticed

(5)

Clinilab

data record

Microscopy

]

Glu’cose

No

Figure 4. Subsidiary worksheets

generated

_from

CLINILAB data records.

for specific gravity and a two-bytefieldfor pH; six fields, one

byte each,for qualitativeassays(glucose, protein, haemoglobin,

ketone bodies, bilirubin and urobilinogen); two fields,

three-bytes each, for possible glucose and protein quantative

determinationsand, finally,fivethree-bytefieldsfor microscope

findings. All these records are numbered in order and then

matched with request records for linking. At the end of this

procedure, results of patient samples without requests and

outstanding requestsare automatically noted.

printing. Reports can, ifr6quired, be printed directly by the

laboratory’s PR 1230,wardbyward.

Discussion

WhentheSMACwasintroduced intotheauthors’ laboratoryin

1978, analytical capabilitywasconsiderably increased and the

laboratory’s clerical work-load grew with it. Many manual

operationshad tobeperformedtopersonalizeclinical reports

andSMACkeyboardentry of census data takesupalotoftime.

Thisworkisalsounnecessary because thesedata arealreadyon

fileintheDPC.The authors also discovered thatmanuallinking

ofthe SMAC IDEEsystem withpatient number and related

datais liable to humanerror.Anotherdrawback ofthe usual

SMACprocedureisthatitsreports,printedonpaper,cannotbe

directlytransferred toadata-bank unless they have previously

been transformed byfurther manualprocedures.

Asfar as CLINILABisconcerned, the instrument gives a

non-personalized report limited to physical and qualitative

tests.

In order to fully exploit the SMAC’s analytical capacity,

which is morethan 1500tests, andtocomplete the CLINILAB

urinalysisreports,alocal informationsystemwasdeveloped by

the authors.Itisintegratedwiththe centralsystemandpermits

the random management of samples and results and the

automatictransfer of information to and from the DPC. The

adoptionofan automatic optical reader(anOPR 1830wand)

permitssampleidentificationand, therefore,on-lineacquisition

of ’personalized’ result records. With theuse ofa floppydisc, censusand testrequest dataaretransferred fromthe DPCtothe

laboratoryeachday.Theauthors’program providesfor

auto-maticlinking of information from theDPC and of theresults

fromon-lineanalysers.Thesedata, processed and completedif

necessary,arestoredonfloppydisc.Theauthors preferfloppy

disc to tape and to remote on-line connection becausetapes do

notpermitadataoutputcontrol and validation routine[5],and

on-line connectionwouldmeanthat the laboratory wouldbe

dependenton theDPC.With thistype ofdistributedlaboratory

computing, theproblemsofanalyserswithdigital output, but

notprovidedwith autonomouscomputerized data equipment,

likeCLINILAB,are also solved.

The use of floppy disc for data exchange between the

laboratory andtheDPC allows easyinformation retrieval for

clinical and statistical research. The system proposed in this

paperischeap, hasaproven versatility andisvery easytouse.

Acknowledgements

This work was supported ’by the CNR research grant

N.80.02256.83,as partof the ’Preventivemedicine’project.

References

WHITCOMB, C.C., VOGT,C.P.andWILBUR, N. M., Computersin

Biology andMedicine,8(1978),197.

GROVES, W. E., American Journal _ofMedical Technology, 44 (1978),575.

WYCOVF, D. A.andWAGNER,J.R.,AmericanJournal_ofClinical Pathology,70(1978),390.

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