2.

A typical biomedical-equipment-procurement process

A typical biomedical-equipment-procurement process has been mapped, based on the
management procedures followed by the Greek National Health-Care System for the
construction of new public hospitals or their expansions. The process involves a Greek public
corporation (called DEPANOM) that assumes the responsibility of defining all-appropriate
equipment and civil-engineering specifications, and bidders (equipment suppliers) that offer bids
on the terms that DEPANOMdefines. The new hospital is delivered, using a turn-key method,
based on the detailed specifications defined by DEPANOM. The process of defining the
appropriate equipment level precedes the civil-engineering specifications, because the hospital
layout and its respective parameters (configuration of special treatment units, dimensions of
rooms that will host specific equipment etc.) are based on the specific characteristics of the
equipment. The focus has been placed on the highly critical aspects relating to biomedical
equipment procurement and particular on the corresponding Department of Biomedical
Equipment (hereafter referred to as DoBE) of the corporation. The DoBE assumes the
responsibility against DEPANOM to carry out the equipment procurement process.

2.1. End-user needs addressed

The roles of DEPANOM (i.e. defining specifications of equipment, assessing bids, selecting the
appropriate equipment and monitoring the equipment life-cycle) have been thoroughly analysed
in order to provide an enhanced business process model. Key features of the enhanced model
include: a) the definition of technical and qualitative specifications of each device; b) the
assessment of bids from technology suppliers; and c) the procurement of the biomedical
equipment itself according to the results of the bids-assessment. Such procedures within
DEPANOM, are currently labour- and paper-intensive, thus adding significant delays and
inefficiencies to the hospital’s design, construction or expansion phases. Additionally, currently
applied practices inhibit informed multiple criteria decision-making on the most appropriate
equipment level and do not exploit the past-experience of the experts through a coherent
methodology. In this respect, a streamlined managerial process addressing the above is deemed
necessary, in order to make the biomedical-equipment procurement procedure more cost-
effective and with a substantially shortened time-cycle. Furthermore, such a new process should
avoid any compromises over the crucial social and qualitative parameters of such an effort. On
the contrary, it should provide a platform that firmly supports them. In order to analyse the
typical biomedical equipment procurement process, a workflow management mapping system
has been used. A number of alternative workflow methodologies and systems were investigated
for this purpose, considering their capabilities in properly depicting the interactions between the
involved actors of the process addressed, as well as their structural approach towards
decomposing the complete process into phases, subprocesses etc. The most appropriate tool for
this purpose is the ActionWorkflow business re-engineering framework. The reasons for this
selection are summarised in the following:
The nature of interactions between the involved actors, closely resembled the workflow model of
the ActionWorkflowframework. The process addressed included actors (person, department etc.)
for whom the task is done (“the customer”) and actors who actually do the work (“the
performer”). The Action Workflow framework is an efficient framework for mapping customer-
performer processes and links, and provides an appropriate platform for analysing and improving
the associated workflows, with a wide installed-base of applications.
The biomedical equipment procurement process includes phases inherently included in the
Action Workflow framework. Such are the preparation, negotiation, performance, and
acceptance phases. Nevertheless, the acceptance phase was not needed in this particular model.
Due to the nature of the phases succession, Action Workflow modelled the complete process
most accurately, at a minimum setup time. In addition to a process modeling tool, the selected
framework provides the ability to generate an application, deploy the workflow-enabled
application, and subsequently gather measurements regarding the business process in production.
The Action Workflow uses industry standards, such as Microsoft Windows/ NT and Internet
platforms, keeping with the company’s long-term strategy of open platforms.

2.2. The Action Workflow framework

The current process has been mapped on the main workflow entitled “Biomedical Equipment
Procurement” . The involved actors are the public Corporation (DEPANOM) which acts as “the
Customer” (placed left on the workflow) while the main Performer is the DoBE, essentially
deciding over the selection of the appropriate equipment (placed right on the workflow). In the
existing process, the Preparation phase (phase one, upper left part of the main workflow)
corresponds to the creation of the Request for Bids (RfB) volume for the new hospital’s
equipment. The Negotiation phase (phase two, upper-right part of the main workflow) includes
the Request for Offers to vendors and the collection of their respective quotes. The assessment of
the bids and the final decision over the most suitable set of equipment is concluded at the
Performance phase of the workflow’s main process (phase three, lower right part of the main
workflow). The Acceptance Phase has not been analysed, since the customer (DEPANOM)
almost always abides by the results of the work of the performer (DoBE). Each phase is broken
up into sub-processes as depicted on the same figure. The current mean average duration (in
days) of each phase is presented at the centre of each workflow. Each sub-process (depicted as a
sub-workflow) has its respective “Customer” and “Performer”, not necessarily the same as those
of the main workflow. More specifically, in the currently applied managerial procedure, the
Preparation Phase of the workflow includes the following sub-processes:
– The identification of the appropriate level of equipment for the hospital site (sub-workflow
“Select appropriate equipment level”, mean duration 20 days). This phase is currently performed
through utilising the expertise of the teamworking over each specific project, and/or through
mining data from previously constructed hospitals, usually similar as far as their demographic
and social parameters are concerned (sub-workflow entitled “Consult previous hospital
constructions”, mean duration 5 days).
– The finalisation of the level of equipment, performed by DoBE, in close co-ordination with
other departments in order to allow the civil-engineering parts of the project to proceed (sub-
workflow entitled “Co-ordinate with other Departments”, mean duration 10 days).
– The definition of the biomedical equipment specifications (sub-workflow entitled “Define
equipment specifications”, mean duration 30 days) which includes thoroughly detailed data and
requirements over a huge-number of parameters for each distinct biomedical device out of the
complete set that will equip the hospital. This sub-process is coupled by a quality assurance
process (sub-workflow entitled “Quality assurance”, mean duration 10 days) which ensures that
every device parameter is reflecting all latest technological advances as well as the legal and
qualitative requirements, set by the Ministry of Health or any other international organisation.
– The creation of the Request for Bids in the format of a detailed Biomedical Equipment Tender
document (sub-workflow entitled “Create Equipment RfB”, mean duration 8 days), which is later
disseminated to all interested biomedical equipment suppliers. The Negotiation Phase of the
current biomedical-equipment procurement process includes bids from equipment suppliers, in
response to the Request for Bids for Biomedical Equipment (sub-workflow entitled “Get Bids”).
The process ends at a specified deadline date. The mean time for the conclusion of the
Negotiation phase is usually 50 working days, initiating from the mailing of the Request for Bids
by DoBE to all interested vendors/ equipment suppliers.
The Performance Phase includes all activities relating to the assessment of the bids offered, on
the basis of the equipment specifications, as stated in the Request for Bids document. More
specifically, this phase includes:
– Legal procedures, which aim to filter out those bids that are not coupled by the requested legal
documentation or the documentation does not prove the vendors legal and fiscal credibility (sub-
workflow entitled “Check Legal Documentation”, mean duration 10 days). This sub-process
currently precedes the evaluation itself.
– The evaluation of the alternative bids which is the core of the assessment work performed by
DoBE (sub-workflow entitled “Check technical specifications”, mean duration 28 days). During
this process all biomedical equipment offers are evaluated against the technical specifications of
each and every device, and those bids that do not conform to the required levels (technical,
qualitative etc.) are rejected.
– Clarifications over the bids, in order to lift any queries regarding further details on the offers
(sub-workflow entitled “Clarifications on bids”, mean duration 10 days).
– The financial assessment of the offers (sub-workflow entitled “Bids’ financial assessment”,
mean duration 8 days). The assessment includes those bids that respect all legal, technical and
qualitative specifications.

Evaluation of the current process

The process map developed was enriched with all details concerning time, delays and errors. The
main information extracted from the map by utilising the Action Workflow consistent
methodology, included a) Touch time – the typical number of hours an employee (or team of
experts) actually spends on a task, which combined with salary information, if available, can
potentially indicate the cost of each step, and of the process itself; b) Lag time – the time
between process steps, when none is working on a task. Examples include sitting in an “in-box”
and waiting for additional information. Lag time is a crucial parameter increasing the final cost
of the process substantially; and c) Value-added analysis – distinguishes between activities that
add value from the Customer’s perspective (Ministry of Health Care – DEPANOM) and those
that do not. By eliminating non value-added activities, the final process was greatly enhanced.
The current typical process, however, has been solely judged upon the criteria of time-cycle and
quality only, since costs associated with the employees’ performance were difficult to evaluate.
A highlight (dashed line) is placed on those activities or processes which have been proved
inefficient on the basis of the aforementioned criteria. More specifically inefficiencies (both
qualitative and in terms of time-cycle) were spotted at:

3.1. The Preparation Phase

Past data concerning previous hospital constructions (sub-workflowentitled “Consult previous
hospital constructions”) are archived using an inconsistent paper-oriented methodology, which
hinders the whole process and adds significant delays. Past-data mining that would potentially
assist decisions over the appropriate level of equipment of new hospitals is slow and inefficient.
Furthermore, archived data (sub-work flowentitled “Consult previous hospital constructions”)
includes only the final selection of equipment with no obvious links between the relationship of
social/ demographic parameters of the hospital site and the desired level of equipment, i.e. there
is no link between needs and actual equipment selections. Additionally, there exists no registered
data from the real-life operation of the hospital and its installed equipment in order to accurately
judge the degree that the equipment level actually served the local needs (sub-workflow “Select
appropriate equipment level”). The appropriate level of equipment (sub-workflow “Select
appropriate equipment level”) is derived solely by the experts input, without any rational and
consistent methodology in place, linking the hospital’s social mission (population served,
number of hospitals in the area, infrastructure requirements etc.) to the appropriate equipment
that should be installed. The above applies equally in the process of defining each individual
biomedical device’s specifications (sub-workflow entitled “Define equipment specifications”).
Although this is a very critical task, no consistent methodology exists managing the qualitative,
technical, financial and regulatory specifications/ parameters of biomedical equipment, in order
to reach the desired level of health-care servicing. It was also found that information over current
technical and regulatory advances is not managed through an integrated database. Thus, the huge
volume of technical and qualitative criteria upon which equipment is finally selected is not
managed properly and is mainly based on the expert’s judgmental input. Detailed specifications
and requirements over a large number of parameters are currently also managed through a paper-
oriented methodology (coupled with simple spreadsheet functions) which renders the whole
process time-consuming. There exists no multi-criteria decision-making system considering each
parameter of every type of device.

3.2. The Negotiation Phase

In the Negotiation Phase, inefficiencies were spotted at the process related to the bids
submission,which includes only paper-format offers, rendering the subsequent evaluation
process more time-consuming.

3.3. The Performance Phase

In the Performance Phase the evaluation of bids (submitted in paper format) is a labour-intensive
operation, mainly assisted through spreadsheets (sub-workflow “Check technical
specifications”). However, it’s a very lengthy process since it requires evaluation of multiple
bids that include numerous devices on the basis of many technical, qualitative etc. parameters.
Furthermore, all equipment judged on the basis of a “fulfills/ does not fulfill” criterion for each
parameter and generally there exists no consistent weighting factor for each technical or
qualitative parameter or a coherent coring system for the technical aspects of each device.
Adding to inefficiency, it was noted that frequently, equipment suppliers do not provide data in
the desired format (measurement units, required details etc.) creating a need for additional
clarifications and thus delays. Another parameter leading to inefficiency in the process stems
from the fact that there exists no centrally planned knowledge-base, handling data from the real-
life operation of each device and the respective services of each equipment supplier, although
procedures are in place, i.e. DoBE already has consistent feedback relating to the actual
operation of each device in existing hospital sites. Consequently, crucial past experience over
each device’s real operation and each supplier’s credibility is lost and not evaluated. Moreover,
the final selection of the supplier that will equip the new hospital site is based solely on the
financial aspects of his bid, as long as all other specifications are met. No consistent combined
technical and financial scoring system exists.
The safety and performance of the device is to a greater or lesser extent dependent upon the in-
use situation (the user and his qualification, the medical procedure, the medical condition of the
patient, circumstances, the man-machine interface, the intended use, calibration, maintenance
etc). Therefore, it is very important that the appropriate device is selected and put into service for
a specific procedure, occasion and patient. The procurement and purchasing are therefore
important steps. The user’s requirements and wishes must be conveyed via the distributor to the
MANUFACTURER so he can offer the most appropriate solution.
HARM may occur if at least one of the following elements is not appropriately covered:
􀂾 The wrong device might be bought due to misunderstanding regarding the actual use in the
practitioner-engineer-clinic-procurer-distributor-MANUFACTURER chain.
􀂾 The wrong device is bought due to inexperienced clinical, technical and administrative staff –
what was needed was never really understood or carried forward.
􀂾 The intended use of a device has shifted since the first specifications were written.
􀂾 An inappropriate device is selected due to: tradition, similar devices already in use, existing
consumables, lack of funding, user policy etc.
􀂾 A mismatch may result in the incorrect operation or inferior performance of a device/system,
unsafe combinations with other devices or costly maintenance.
􀂾 An expensive combination of devices might be bought because of the selection of a cheap
main unit and costly consumables.

Interested parties such as clinical engineering staff and the Radiation Protection Advisor
should be involved at the contract stage.
The medical device will be delivered with
􀂾 all information needed to verify whether the device is properly installed and can operate
correctly and safely, plus details of the nature and frequency of the maintenance and calibration
needed to ensure that the device operates properly and safely at all times
􀂾 where appropriate, information to avoid certain RISKs in connection with implantation of the
device,
􀂾 information regarding the RISKs of reciprocal interference posed by the presence of the
device during specific investigation or treatment,
􀂾 in the case of devices capable of emitting radiation for medical purposes, details of the nature,
type, intensity and distribution of this radiation
􀂾 the instructions for use, including details allowing the medical staff to brief the patient on any
contra-indications and any precautions to be taken [6].
The required language of all documentation is to be clearly defined in the contract, taking into
account the prevailing national regulations.