28 Point Checklist - way to achieve

S.M.A.R.T commissioning of medical

equipment in a new Hospital
Published on October 23, 2015
Like28 Point Checklis t - way to achieve S.M.A.R.T commissioning of medical equipment in a new Hospital

Deepak Agarkhed
General Manager -Facilities & Quality with experiance of 4 Green field
Hospital commissioning

The ever evolving role of technology in healthcare allows hospital to diagnose

monitor and treat faster, with greater accuracy enabling better service and faster
recovery. This is only possible provided medical equipment is safely commissioned in
suitable environment, properly calibrated to provide accurate results, handled &
maintained by trained staff.

The challenge:
The hospital project management was based on Toyota principles of quality in
healthcare. The project was led by experienced Project Director, Medical Director,
Head - Clinical engineering and purchase. The project timeline was decided of 21
months. A brainstorming session was organized to make Strategy for seamless
execution process from procurement up to the commissioning of medical
equipment. The various aspect for delays, snags, miscommunication, documentation
compliance etc. was discussed. One of the major challenges anticipated by team was
proper commissioning of en masse of medical equipment in short duration of time
in synchronization with hospital commissioning activities. The
challenge of delay in recruitment of user department staff was also anticipated. Based
on past project management experience the Head- Quality and Clinical Engineering
identified the need for detailed & standardized of medical equipment acceptance
checklist.

Key challenges anticipated were:

Hospital wide multiple equipment commissioning at the

same time

Short timeline from inception to commission the hospital

Challenge of Synchronizing
hospital & equipment commissioning
 Non uniformity in industry practice of equipment handover

Expected technical snags at the commissioning

Recruitment of user department staff for acceptance

Clinical engineers v/s equipment ratio

The acceptance of medical equipment is multifaceted function. It involves various
internal stakeholders i.e. stores, clinical engineering, end user, finance, administration.
One of the major challenge was every medical equipment service providers (i.e.
vendors) follow different practice of handover of medical equipment to hospital. After
shifting the equipment from stores to designated clinical area, as a common practice,
the service engineer of respective medical equipment vendor will install the
equipment in coordination with clinical engineer. The end user training are provided
soon after the installation so that patients can be taken for desired clinical application.
There are possibilities of encountering technical snags due to environmental
condition, functionality and improper installation. Improper documentation during
commissioning like non availability of calibration records may get scrutinized hospital
accreditation audit.

To achieve the commissioning target of time, safety, legal and

regulatory compliance; the strong need to standardize
commissioning process was felt. The goal was to anticipate
/consider all aspect and mitigate equipment related risks and
delays.

The specific goals of devising checklist were:

Standardization of installation/ commissioning process

Establish initial inspection/acceptance testing parameters of all
equipment considering installation, operational and performance
aspects.
Reduction of equipment related risks and individual subjective
redundancy.
Standard process of acceptance among the team
Avoid incomplete documentation/ delays in installation
Ensure safe maintenance practice.

The Process:
Convene Team to Design checklist: In order to address on effective &
efficient methodology for commissioning of medical equipment, the team
compromising of quality & Clinical engineering manager along clinical engineers
brainstormed on the best possible process to adopt. The team discussed various
contributing factors for unsafe & delay in commissioning of equipment. The fish bone
diagram to graphically depict various causes contributing to delay/unsafe
commissioning of medical equipment prepared by quality manager along with clinical
engineering team.

With due consideration to all practicable & measurable factors for safe commissioning
of medical equipment, checklist with 28 point measurable comprehensive checklist
was devised and implemented . A checklist is a type of informational job aid used to
reduce failure by compensating for potential limits of
human memory and attention.

The checklist was designed on S.M.A.R.T principle

Specific - requirement of infrastructure & environmental condition

Measurable functionality & calibration of equipment, training of staffs

Achievable realistic target for checks, documents and timeline

Relevant team, licensing documentation

Time bound each activity was time bound for vendor and project team as well as
users

Implementation of checklist
Checklist was shared with clinical engineers and training/ implementation session on
use of checklist was conducted. Most of the points are self-explanatory. They were
informed about some of the points which may not be relevant to certain equipment
like software license document for operating table & were asked to fill as not
applicable. The preventive maintenance related checklist and safe handling of
equipment i.e. Dos & dont are also obtained. The service report is taken along with
installation, performance and operating qualifications from service providers.

The companies were provided 28 point checklist along with (RFP) request for
proposal so that they have time and clarity on documents expected at the time of
installation /commissioning.

Checklist signed for accountability of the completion of

documentation:
 1. Prepared by
2. Supervised by
3. Reviewed by user department
4. Authorized by GM- Clinical Engineering
5. Final authorization by Medical Director

Challenges faced during implementation:

The main challenge faced during implementation was

compliance from vendors: few of the were resistant to commit to
provide all document at the time of installation as its not a
routine industry practice
Delay in submission of some of the documents
Built stress on the clinical engineers for compliance adherence

The result: Gains & Holding on Gains

Gains:
The comprehensive commissioning checklist was implemented for most of the
medical equipment during commissioning by team of clinical engineers in full
concurrence with user team. As this activity was even new to most of medical
equipment, breaking the inertia and getting all relevant documentation was major
hurdle to clinical engineers. With timely support from top management, maximum of
the points are addressed for most of the medical equipment.

Timely training of end users on functionality has resulted in few service related
complaints. There are no adverse events related to medical equipment harming
patients occurred so far as most of safety issues are addressed as part of
commissioning itself. The calibrated equipment coupled with trained users has led to
in accurate results from equipment in shortest possible time. As a part of quality
indicator, acceptable values are obtained for % of re dos and reports correlating with
clinical diagnosis in radiology department & laboratory.

28 point" checklist Advantage:

It gave great clarity to all the stakeholders
It standardized commissioning process
Vendors had prior information on documents and
compliance requisite
Nullified commissioning knowledge and experience level
issues, as well as memory or personal redundancy,
 potential of miscommunication which can contribute to
delay, last minute rush
Ease among clinical engineering team at the time of leave
a complete objective team approach
Structured efficient and professional working environment
Maximized Project Efficiency:
It brought transparency with vendors on quality
expectations,
Minimized trivial activity supervision,
Achieved ease of traceability for pending issues/
documents,
Each Clinical Engineer felt empowered, independent,
efficient with enhanced output (efficiency)
Synchronized activities enhanced departmental and
hospital efficiency
As the process is established from start of hospital commissioning, there is no possible
measurability of outcome of process earlier.

The other benefits attributed as a result of establishing comprehensive commissioning

checklist are as follows.

The team approach for commissioning of any equipment has

resulted in collective ownership among both end user and
clinical engineers. This has resulted in developing harmonic
relationship among them and theres constant continuity in their
approach to any issues be on training or on maintenance.
No major problems are encountered by clinical engineering
team whenever the technical audits are conducted as most of
the information related to any equipment including brochure,
technical datasheet, commissioning report besides the scope of
supply are readily available in clinical engineering department.
During accreditation of hospital, the calibration certificate of
equipment, planned preventive maintenance tracker, user
training records which are captured at the time of acceptance of
equipment will be handy.
The clinical engineers are trained on first level of medical
equipment maintenance troubleshooting and have relevant
service manual for troubleshooting the equipment. This will
 contribute greatly in reduction of downtime for medical
equipment. The quality of service provided by clinical
engineering team is greatly enhanced as a result of
implementation

Holding on Gains
The sustainability of the project made practicable by adopting following things.

The 28 point comprehensive commissioning checklist is now

provided as part of annexure along with medical equipment
purchase order.
The checklist forms part of activity sheet for clinical engineer
during commissioning as it is integral part of Standard operating
procedure (SOP) of clinical engineering.
The adoption of similar pre-commissioning checklist will help any hospital in general
and Clinical engineering team in particular to mitigate possible compromise in
qualitative equipment commissioning work in turn ensuring safety of patient & staff
while using the equipment and aligning to needs hospital accreditation requirement.

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For further details please send your mail on deepakagarkhed@gmail.com