Subject: Biomedical laboratory services Gold level

NOV. 2019

# Criteria Progress Due Responsible Remarks Potential

% Date Person Challenges
1.1 The team collects
information at least
every two years
about service
volumes and wait
times for accessing
laboratory services.
1.2 The team collects
information at least
every two years from
laboratory users and
clients about their
needs for laboratory
services.
2.1 The team establishes
an agreement with
each laboratory user
(organization) that
outlines their
requirements and
respective
responsibilities.
2.2 The team verifies
that it has the
capacity to meet the
requirements in the
agreement.
2.3 The team reviews its
agreements at least
every two years to
confirm requirements
are being met and
documents the
reviews.
2.4 The team maintains
records of all
agreements,
including any
relevant changes
made to meet
applicable
regulations.
2.5 The team informs
laboratory users
(organization) in a

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 timely manner of
changes to or
significant deviations
from the agreement
that may have an
impact on
examination results.
3.3 The team verifies
that test results from
referral laboratories
are given to the
laboratory user in a
timely and accurate
way.
4.1 The team establishes
working relationships
within its team and
with laboratory users.
5.2 The team defines
each member's
responsibilities and
required
qualifications in
position profiles.
5.3 The team recruits
members based on
the qualifications
required in the
position profiles.
5.4 The team is made up
of a sufficient
number of qualified
team members who
are able to carry out
the required volume
of laboratory
services, day-to-day
operations, and any
other responsibilities.
5.5 The team has a
laboratory director
who is responsible
for overseeing clinical
activities within and
outside the
laboratory.
5.6 The team has an
administrative leader
who is responsible
for the administration
and management of

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 services within and
outside the
laboratory.
6.1 The team receives a
comprehensive
orientation to the
organization's
laboratory's services.
7.2 The laboratory has
sufficient space to
carry out laboratory
services.
7.4 The laboratory
provides clients with
access to
washrooms.
7.6 The laboratory's
space for record
keeping and other
administrative
activities is separate
from pre-analytical
and analytical testing
areas.
7.7 The environmental
conditions of the
laboratory's storage
space protect the
integrity of its
samples and
supplies.
7.8 The laboratory is
equipped to
communicate
information within
and outside the
laboratory in an
efficient manner.
8.1 The laboratory's work
areas are clean and
well-maintained.
8.2 The layout of the
laboratory prevents
cross-contamination
by separating
incompatible
activities.
8.4 The team receives
training on hand-
washing procedures

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 and has access to
hand-washing
facilities that are
adequately supplied.
8.5 The team ensures
the safe collection,
containment, and
disposal of waste
materials in line with
applicable
requirements.
9.1 The team has the
equipment needed to
maintain appropriate
environmental
conditions in
refrigerators and
other critical
equipment.
9.2 The team regularly
monitors and records
environmental
conditions within the
laboratory.
9.3 The team identifies
and reports any
environmental issues
within the laboratory.
9.4 The team ensures
critical equipment
such as refrigerators
is protected with an
uninterruptible power
supply.
10.1 The laboratory has a
license, certificate, or
permit to carry out
its services, as
required by
applicable laws and
regulations.
10.2 The team has access
to applicable laws,
regulations, and
standards of practice.
10.3 The team has
instructions on how
to implement
applicable laws,
regulations, and
standards of practice,

4
 and how to obtain
more information or
training about them.
10.4 The team has a
process to keep track
of updates to
applicable laws,
regulations, and
standards of practice.
10.5 The team monitors
its compliance with
laws, regulations,
and standards of
practice, and makes
improvements to its
instructions or
training activities as
required.
11.1 The team has a
process to develop
clear and concise
SOPs that are in line
with applicable
regulations and
standards of practice
for laboratory
services.
11.2 The team has access
to SOPs that are
applicable to the
activities it carries
out.
11.3 The team updates its
SOPs every two years
or more often if
required.
12.1 The team develops a
transparent and
respectful
relationship with
clients and laboratory
users.
12.2 The team obtains the
client's free and
informed consent
when appropriate,
and collects only the
personal information
necessary to
complete the
procedure.

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12.3 The team uses
samples for the
stated purpose only.
12.4 The team informs
laboratory users if a
critical result needs
to be followed up
with access to
counselling.
12.7 Team members
adhere to their
respective
professional codes of
ethics for laboratory
practice, if applicable.
13.2 The team selects
equipment that can
be easily cleaned and
disinfected.
13.3 The team provides
appropriate members
with step-by-step
equipment operating
instructions as well
as troubleshooting
and equipment
malfunction
guidelines.
14.1 The team follows
manufacturer
instructions and up-
to-date SOPs to
maintain, inspect,
validate, and
calibrate equipment.
14.2 The team regularly
cleans and disinfects
equipment, and
keeps the equipment
protected when not
in use.
14.3 The team identifies,
investigates, and
corrects problems
with equipment in a
timely way.
14.4 The team removes
equipment that is
damaged or in poor
working condition
from service and

6
 labels it as out of
order along with a
statement indicating
the problem and the
action to be taken.
15.2 The team maintains a
list of suppliers for all
supplies, reagents,
and media.
15.3 For purchased
supplies, reagents,
and media, the team
validates the quality
control testing done
by the manufacturer.
15.5 The team does not
use inappropriate,
deteriorated, and
substandard supplies,
reagents, and media.
15.7 The team uses
supplies, reagents,
and media only for
their intended
purpose.
15.8 The team has access
to complete and up-
to-date records of
supplies, reagents,
and media.
16.1 The team follows
SOPs to prepare
supplies, reagents, or
media.
16.2 To avoid
contaminations or
toxicity, the team
uses analytical grade
materials to prepare
supplies, reagents, or
media as required by
its SOPs.
16.3 The team uses sterile
techniques, as
applicable, to prepare
supplies, reagents, or
media.
16.4 The team uses water
of the highest purity
to prepare supplies,

7
 reagents, or media
as required by its
SOPs.
16.5 The team
understands and
follows safety and
information sheets on
chemicals and
hazardous materials.
16.6 The team assesses
each lot of media
that it produces on-
site before it is used
and records quality
control results.
17.1 The team follows
SOPs for
reprocessing and
sterilization that
comply with
applicable laws and
regulations.
17.2 The team uses non-
toxic detergent and
the highest purity
water to wash and
rinse glassware and
non-disposable
plastic ware when
required by its SOPs.
18.1 The team performs
analyses at the
written or electronic
request of an
authorized health
care professional.
18.2 The team follows an
SOP to respond to
verbal requests.
18.4 The request form
complies with
applicable
requirements and
standards of practice.
18.5 The team follows a
policy for identifying
and handling urgent
requests.
19.1 The team follows
SOPs for preparing

8
 the client, identifying
the sample needed,
collecting the sample,
safely disposing of
the materials used to
collect the sample,
and maintaining the
client's confidentiality
throughout the
process.
19.2.1 The organization has
a documented
method of client
identification that is
standardized across
the organization.
19.2.2 The team uses at
least two client
identifiers before
providing laboratory
services.
19.3 The team labels each
sample with the
relevant information.
19.4 The team ensures
that all samples are
traceable to the
client.
20.1 The team follows
SOPs to transport
samples to and from
the laboratory in a
safe and confidential
manner that is in line
with applicable laws
and regulations.
20.2 The laboratory
follows an SOP for
maintaining the
integrity of samples
handled after hours,
if applicable.
20.3 The team records all
samples received,
identifying the date
and time they were
received and the
individual responsible
for receiving them.
20.4 The team accepts or
rejects each sample

9
 according to
established criteria.
20.5 The team follows an
SOP for safely
handling leaking
samples and
contaminated forms.
21.1 The team follows
SOPs to decide on
examinations that are
needed and the
procedures to be
followed.
21.2 The team only uses
examination
procedures that have
been validated for
their intended use.
22.2 The team identifies
possible uncertain
results and
determines their
importance in how it
might affect
interpretation.
22.3 The team identifies
and quickly
addresses all
inaccuracies,
problems, or
deficiencies.
22.4 Once samples are no
longer needed for
examination, the
team safely disposes
of them in
accordance with
applicable regulations
for waste
management.
23.1 The team has a
standardized report
format that is
communicated to all
laboratory users.
23.2 The report uses
language,
vocabulary, syntax,
and nomenclature
consistent with that
used by applicable

10
 professional bodies.
23.3 The reports are
legible and accurately
reflect the results.
23.4 The report clearly
states if the quality
of the sample was
unsuitable for the
examination or may
have compromised
the end results.
23.5 The team follows
SOPs for handling
results that fall within
critical results.
24.1 The team has a
policy and procedure
manual for the LIS
and its applications
that is available to
team members at all
times, and that is
regularly updated to
make sure it is
complete and
accurate.
24.8 The team's
information system
can provide a
complete summary of
all outcomes of a
laboratory procedure
and any abnormal or
unusual events.
25.1 The team maintains a
comprehensive
record for each client
and procedure that is
in line with applicable
regulations.
25.2 The team can easily
retrieve records as
needed.
25.5 The team protects
the security and
confidentiality of
records.
26.3 The safety program
includes orientation
and training

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 programs, and
monitoring and
evaluation.
26.4 The safety program
includes a safety
manual that is
available to all team
members at all times.
27.1 The team uses risk
group classifications
to classify biological
agents.
27.3 The team wears
protective clothing
and Personal
Protective Equipment
(PPE) according to
the organization's
policy and applicable
regulations.
27.4 The team uses safety
practices when
handling, examining,
or disposing of
biological and
chemical materials.
27.5 The team identifies,
reports, records, and
monitors in a timely
way adverse and
sentinel events
according to the
organization's policy
and applicable
regulations.
28.1 The team selects
new methods based
on available evidence
such as scientific and
literature reviews and
best practice
guidelines.
28.2 The team conducts
preliminary studies to
validate new
methods before their
routine use.
29.1 The team has a
comprehensive
quality management
system.

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29.2 The team defines the
elements of the
quality management
system in a quality
policy statement and
makes it available in
a quality manual.
29.3 The team assigns an
individual to establish
and oversee the
quality management
system.
29.4 The team identifies
measurable
objectives for its
quality improvement
initiatives and
specifies the
timeframe in which
they will be reached.
29.5 The team identifies
the indicator(s) that
will be used to
monitor progress for
each quality
improvement
objective.
29.7 The team sets
targets and tracks
wait times and
average response
times for elective,
urgent, and
emergent requests
for laboratory
services.

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