Laboratory Information System, integrated with the Hospital Information System, has been developed at the G.Pasquinucci Hospital, section of Institute of Clinical Physiology of National Research Council (CNR), specialized in adult and paediatric cardiac surgery. The aim was to automate the testing process from clinical departments to laboratory and back into medical record. Laboratory workflow consists of three parts: (a) test ordering by clinical staff, printing bar-coded ID labels and transmitting orders by network to laboratory; (b) processing test requests and controlling identified specimens by laboratory staff, providing work orders to analytical instruments and validation of results authorizing delivery into the hospital clinical repository; (c) consulting test results in clinical departments by referring physicians through the electronic medical record. This year the system has been used on adult patients processing 135000 laboratory tests concerning chemistry, haematology, coagulation and immunology

Andrenelli, Andrea

Cardillo, Maria

Carducci, Tiziano

Conte, Raffaele

Gwynne, S

Landucci, Leonardo

Lauciello, P

Macerata, Alberto

Parri, M S

Pierotti, Danilo

Pisani, Paolo

Rocca, Emiliano

Taddei, Alessandro

Vellani, Antonio

PUblication MAnagement

Laboratory Data Integration into Medical Record 
 
A Taddei1, P Pisani2, A Vellani1, S Dalmiani2, G Piccini1, T Carducci1, G Kraft1, E Rocca1, S Storti1, 
A Andrenelli1, MS Parri1, M Cardillo1, P Lauciello1, S Gwynne1, A Macerata2 
 
1CNR Institute of Clinical Physiology, G Pasquinucci Hospital, Massa, Italy 
2CNR Institute of Clinical Physiology, Pisa, Italy 
Abstract 
Laboratory Information System, integrated with the 
Hospital Information System, has been developed at the 
G.Pasquinucci Hospital, section of Institute of Clinical 
Physiology of National Research Council (CNR), 
specialized in adult and paediatric cardiac surgery. The 
aim was to automate the testing process from clinical 
departments to laboratory and back into medical record. 
Laboratory workflow consists of three parts: (a) test 
ordering by clinical staff, printing bar-coded ID labels 
and transmitting orders by network to laboratory; (b) 
processing test requests and controlling identified 
specimens by laboratory staff, providing work orders to 
analytical instruments and validation of results 
authorizing delivery into the hospital clinical repository; 
(c) consulting test results in clinical departments by 
referring  physicians through the electronic medical 
record. This year the system has been used on adult 
patients processing 135000 laboratory tests concerning 
chemistry, haematology, coagulation  and immunology. 
 
1. Introduction 
In health-care laboratory-test results are largely used 
routinely for supporting physicians to confirm  a 
suspected diagnosis, to monitor effects of treatment or to 
assess prognosis [1]. The primary function of clinical 
laboratories is to acquire, validate, interpret and 
communicate information derived from analysis of 
patient specimens. Quality of laboratory services depends 
not only on accuracy and precision of test results, but also 
on the timeliness of  delivery. In hospitals several 
millions of tests are performed each year. Increasing 
laboratory workload promoted application of computers 
since many years ago. Today Laboratory Information 
Systems (LIS) are used in most hospitals for supporting 
both data processing and laboratory management. 
Advanced analytical instruments for automated 
processing of large series of tests are available, equipped 
with on-line interface for uploading work orders and 
providing test results. Various laboratories are 
distinguished, each handling different types of specimens 
and using different analytical techniques; typical 
specialties include clinical chemistry performing 
chemical analysis of samples, haematology performing 
tests on cellular elements of blood, immunology 
measuring antigens and antibodies in body fluids.   
Testing process is divided into two cycles: one taking 
place in clinical departments or ambulatories (first, test 
ordering and specimens collection, and at last result 
reporting) and the other within the laboratory (analysis 
and validation) (figure 1). 
The classical way to order a laboratory test for a 
patient is to fill in a request (often mark-sense form) on 
which test parameters are pre-printed together with 
patient identification [2]. The form is sent with the 
patient’s specimens to laboratory where test requests are 
entered into LIS, either automatically (by optical reader in 
case of mark-sense forms) or manually. If LIS is linked to 
Hospital Information System (HIS) (according to IHE) 
[3] it is possible to request, directly from departments, 
laboratory tests, even by Electronic Medical Record 
(EMR). Test requests can be transmitted through network 
to the LIS, just waiting specimen arrival in the laboratory.  
In the latter approach patient data are automatically 
provided from HIS  to LIS, as well as identification labels 
for each specimen container. Work lists are generated 
with position assignment of specimen containers in trays. 
In case of modern instruments bar-coded labels can be 
 
Test request 
Specimens collection 
and delivery 
 Reception and 
 work orders upload 
Interpretation 
Laboratory report 
 
Specimen 
analysis 
Quality control 
and validation 
Laboratory cycle 
Extra-lab cycle 
Figure 1 The testing process 
 
0276−6547/05 $20.00 © 2005 IEEE 909 Computers in Cardiology 2005;32:909−912.
  
used for enabling automated identification of specimens. 
Test results are subject to validation by the laboratory 
staff  and  then authorized for reporting to the requesting 
clinician. At the Institute of Clinical Physiology (IFC) 
(health care institute of National Research Council, 
specialized in study and treatment of cardiovascular 
pathologies) HIS development was initiated ten years ago 
by a national project (SPERIGEST) [4]. Today full 
integration of clinical and administrative information over 
a networked structure has been achieved; access to patient 
information is made available through EMR [5,6]. In this 
framework a LIS, integrated with HIS, was developed for 
the automation of workflow of clinical laboratory testing. 
The aim was to automate test  ordering and collection of 
identified specimens from clinical departments or 
ambulatories, providing work orders to analyzers and 
getting back results, finally transmitted, after validation 
and authorization,  into patient EMR (figure 2).  This 
system was first developed and applied at the head of IFC 
in Pisa and recently was adapted for use at the institute 
section in Massa (G.Pasquinucci Hospital), specialized  in 
adult and paediatric cardiac surgery. 
2. Methods 
The LIS, developed at G.Pasquinucci Hospital, is 
based on a client-server networked architecture. Nursing 
workstations were set up in the clinical departments 
(Cardiology, Cardiac Surgery and ICU) for test ordering 
and printing bar-coded ID labels, while in the laboratory 
commercial software (LABITUP, Sisge) was applied for 
data exchange with analyzers. The LIS was linked with 
the HIS allowing identification of patients at nursing 
workstation and reporting test results into electronic 
medical record (EMR). Graphical applications, accessing 
both LIS and HIS database servers (SQL IBM DB2), 
were previously developed in MS-C language under IBM 
OS2 by one of the authors (Paolo Pisani)  for use at IFC 
in Pisa [5]. These programs were modified and extended 
for application in the departments of G.Pasquinucci 
Hospital.  Automated analytical instruments, charged of 
most routinely performed tests, were interfaced with the 
LIS; they concern clinical chemistry (Beckman CX), 
immunology (Abbot  Axsym), coagulation (Dasit Sysmex 
CA-1500) and hematology (Dasit SF 3000). Other few 
tests (usually performed outside the hospital) continue to 
be managed manually,  actually requiring clinical staff to 
enter corresponding results directly into EMR to complete 
laboratory test data needed routinely for patient health 
care.  
The scenario includes the following tasks (figure 2):  
o Management of test requests: ordering tests, 
collection and labeling of sample specimens. 
o Laboratory processing: work orders for analysis of 
specimens and validation/authorization of results 
o Storing results into the clinical repository for 
consultation by clinical staff through EMR. 
Figure 2 Integrated laboratory testing workflow 
910
  
2.1. Management of test requests 
Laboratory test requests, prescribed by physicians in 
the care department, are entered in clinical departments 
by nursing staff using the “order placer” application.  
First step is the selection of the single patient from the list 
of patients admitted in the department (retrieved by HIS 
database through SQL query). In case patient admission 
has not yet been recorded by administration (ADT), a 
temporary record is created.  Next step is the selection of 
tests from the full list or, more simply,  from “batteries” 
of tests, routinely requested in common situations (e.g. 1st 
day admission, post-surgery).  
Tables with relations were defined in the LIS database to 
characterize objects relating to testing process. Tests 
currently performed in the laboratory (113) are defined by 
a reference table, in which each test is identified by a key 
code and characterized in terms of destination laboratory 
analyzer, color of tube, range of normal values, group 
assignment, printing order and format (Table 1). Each 
single request is recorded  in the table of requests and the 
series of tests (coded according to reference table) are 
recorded in the related table of  requested tests. 
Each time any request with the selected tests has been 
recorded through the nursing workstation into the LIS 
database, automated retrieval from the laboratory 
workstations is enabled. Actually requests are filtered 
according to specific destination, as defined in the 
reference table (e.g. see F*111 or F*151 in table 1: the 
former corresponding to chemical chemistry and the latter 
to immunology), and distributed to the corresponding 
analytical instrument. 
Lists of the requested tests and bar-coded labels are 
printed with the patient’s name, unique identification 
number (ID), department and date of collection for each 
individual specimen container (figure 4).  A proper 
number of labels and requests are provided depending on 
how many types of tests (performed on different 
analyzers) are requested or from the quantity of tests of 
the same type.  Specimen tubes, identified by ID labels, 
are finally transferred to the laboratory. 
2.2. Laboratory processing 
The sequencing of material flow (the specimens) and 
the electronic flow (the test request) is not necessarily 
synchronized. The laboratory staff  looks at  each request 
using “order filler” application and ensures that all 
required specimens are available and conform to the order 
(figure 5). The order is rejected or accepted with 
modifications if needed. The order is then confirmed and 
scheduled by “order filler”.  Each order  is splitted into 
one or more work orders, either (the majority) sent to the 
corresponding automated analyzers (chemistry, 
immunology, coagulation or hematology) or manually 
code dest test name color range norm. grouping
202  F*111   Transaminasi G.O. (AST) M 02~ IU/L~ 0 - 50~ -01-02-11-
204  F*111   Fosfatasi Alcalina (ALP) M 02~ IU/L~ 42 - 121~ -01-02-51-
205  F*111   Latticodeidrogenasi (LD-P) M 02~ IU/L~ 266 - 500~ -01-02
502  F*151   Digossina 1 02~ ng/mL~ 0.3 - 2.0~ -32-
996  F*151   Vancomicina 1 02 ~ ng/ml ~30 - 40 ~ -32-
Table 1  Reference test definition 
Figure 3 Test ordering by nursing staff 
 
Figure 4 ID bar-coded labels and test orders  
Figure 5 Laboratory staff controlling test 
requests, preparing work orders and validating 
911
  
managed by laboratory staff. Identified specimen tubes 
are distributed to the analyzers according to the work 
orders and uploaded in the trays in the positions assigned 
by application program. Tubes can be positioned 
randomly if bar code recognition has been enabled.  Then 
the laboratory staff performs a validation (technical and 
clinical) of all the results returned from analyzers and 
finally authorizes only the right ones, which are recorded 
into the clinical repository (ARCA) of medical records. 
Reports are finally printed and signed by laboratory head. 
2.3. Reporting results in EMR 
Results of laboratory tests, managed by LIS and 
recorded in clinical repository (ARCA), are reported for 
consultation in the EMR, which is routinely used in the 
hospital for patient care.  Test results are represented in 
tabular form where abnormal values are marked for 
evidence and the applied normality ranges are made 
available. Graphical trends of  parameters can be 
represented for analysis of time variations. PDF printouts 
are provided for documentation of patient medical record. 
 
3. Results 
Since January 2005 the system has been used routinely 
for automating flow of laboratory data on adult patients 
admitted in departments of Cardiology, Cardiac Surgery 
and ICU. Up to 5500 requests have been processed for a 
total amount of 135000 tests (out of 113 types). Recently 
application to pediatric patients (Cardiology/Cardiac-
surgery and ICU) has been scheduled. 
 
4. Discussion and conclusions 
Both clinical and laboratory staff, after initial training 
and efforts, have got advantages using the system in 
terms of both time saving and reliable documentation. 
The nursing staff found the pre-printed labels very useful 
and effective. Reports of test values in EMR were 
effective for patient care by physicians in clinical 
departments. Increasing laboratory workload with the 
expected extension of laboratory service to outpatients 
will further benefit by the automation of workflow. Given 
IHE initiatives [3] for standardization of laboratory 
integration in health care enterprises using HL7 protocols, 
a revision of the actual system is scheduled to be 
eventually upgraded for improving performance. 
Acknowledgements 
We gratefully acknowledge advice of physicians and 
nursing personnel at G.Pasquinucci Hospital and of 
colleagues at IFC in Pisa: D.Pierotti, (database); 
L.Landucci (network), A.Ciriegia (operating systems). 
References 
[1] Smith JW, Svirbely JR. Laboratory information systems. 
In: EH Shortliffe, LE Perreault, editors. Medical 
Informatics: computer applications in health care. Reading, 
MA, USA: Addison-Wesley Publishing Company, 1990: 
273-297.  
[2] Van Bemmel JH, Musen MA. Handbook of medical 
informatics. Houten (NL): Bohn Stafleu Van Loghum, 
1997: 207-17.  
[3] http://www.ihe-europe.org/ IHE laboratory technical 
framework, vol.1, rev.1.1, 2004. 
[4] Macerata A, Landucci L et al. Networking for health care 
administration and delivery: the information system at the 
CNR Institute of Clinical Physiology. In: Proceedings of 
Health Telematics ’95. Pisa: CNR, 1995, 113-18. 
[5] Carpeggiani C, Dalmiani S, Taddei A et al. Use of an 
electronic medical record in a department of Cardiology.   
Computers in Cardiology 2000; 27: 291-294.  
[6] Taddei A, Dalmiani S, Piccini G et al. Data integration in 
cardiac surgery and resource management. Computers in 
Cardiology 2003; 30:279-282. 
 
Address for correspondence 
Alessandro Taddei 
CNR Institute of Clinical Physiology 
Hospital Pasquinucci – Medical Informatics 
Via Aurelia Sud – 54100 Massa (Italy) 
taddei@ifc.cnr.it 
Figure 6   Reporting test results in EMR 
Figure 7  Plotting parameter time variations 
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Laboratory data integration into medical record

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