A Andrenelli

A Macerata

A Taddei

A Vellani

E Rocca

G Kraft

G Piccini

M Cardillo

Ms Parri

P Lauciello

P Pisani

S Dalmiani

S Gwynne

S Storti

T Carducci

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Laboratory Data Integration into Medical Record 
 
A Taddei
1, P Pisani
2, A Vellani
1, S Dalmiani
2, G Piccini
1, T Carducci
1, G Kraft
1, E Rocca
1, S Storti
1, 
A Andrenelli
1, MS Parri
1, M Cardillo
1, P Lauciello
1, S Gwynne
1, A Macerata
2 
 
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. 1
st 
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). 
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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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Laboratory Data Integration into Medical Record

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