VERTICAL ASSESSMENT - Sanas

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VERTICAL ASSESSMENT
ISO 15189 FOR MEDICAL LABORATORIES
Organisation’s
SANAS No.
Laboratory
Laboratory Representative
Area / field of operation
Assessor
Test Report (Select one or more final Test Report. Record at least the number, date and the accredited parameters measured.)
Req. no:
Date:
Requested tests on which Vertical Assessment is performed:
Requiremens for ISO/IEC 15189 for medical laboratories. Paragraph number against right margin.
(Give details below the requirements to INDICATE WHAT HAS BEEN CHECKED and comment on any positive aspects. Record Clause
all information pertaining to the selected data relevant to the standard questions below.)
REQUISITION FORM, SAMPLE IDENTIFICATION, TRANSPORT AND RECEIPT. 5.4
How was the primary sample traceable to an identified
individual?
5.4.5
a) What was the unique identification of the patient?
5.4.1
b) Was the name, address and/or location of the
requesting doctor?
c) What was the type of sample and the anatomical
site (Histo)
d) What examinations were requested?
e) What relevant clinical data for the test was
recorded?
f) What was the time and date of specimen
collection?
Were the instructions for sample collection and
handling available to those responsible for primary
sample collection?
5.4.2
B1.6
Were all requested tests performed and reported
within the laboratory’s TAT?
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Did the laboratory report form contain, but not limited
to, the following:
5.8.3
a) Clear and concise results, including the units
of measurement (where applicable);
b) The identification of the laboratory that issued
the report;
c) The patient’s name, address and hospital
number (where applicable);
d) The name and address of the person
requesting the test;
e) The date and time of specimen collection and
the time received by the laboratory;
f) Date and time of release of the report;
g) The type of sample & tests requested;
h) Results reported in SI units where applicable;
i) Reference ranges for each test (preferably by
age and gender);
j) Interpretation of results, where appropriate;
k) Other comments (e.g. quality or adequacy of
primary sample);
l) Identification of person authorising the release
of the report;
m) Both original and corrected results, if relevant;
n) The signature or authorisation of the person
accepting responsibility for the content of the
report;
Where a sample was unsuitable for the performance
of the test, did the report form clearly indicate this, is
there a procedure in place to cater for this?
5.8.5
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Are instructions for sample collection and handling
available?
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5.4.3
a) Are there copies of or reference to :
1) The list of available tests;
2) Consent forms (where required);
3) Instructions to patients on preparation
before primary sample collection;
4) Information for users of laboratory
services on indications for and selection
of test;
b) Procedures for:
1) Preparation of the patient;
2) Identification of the primary sample;
3) Collection, containers and preservatives;
c) Instructions for:
1) Completion of the request form (or
procedure for electronic request);
2) Type and amount of primary sample;
3) Sample timing (if required);
4) Special handling (refrigeration, urgent
etc);
5) Labelling of primary samples;
6) Necessary clinical information;
7) Positive identification;
8) Identity of person collecting the sample;
9) Safe disposal of collection material.
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How did the laboratory ensure that samples that were
transported to the laboratory:
5.4.6
a) Reached the laboratory within an appropriate
time;
b) Have not been exposed to temperatures
outside an acceptable range, where
appropriate;
c) Have been transported safely in compliance
with national, regional and local safety
requirements;
Are instructions for the receipt of samples in the
reception area available, and were they followed?
5.4.3
What was the date and time of receipt of samples and
the identity of the receiving officer?
5.4.7
Was this within the stipulated time frame?
Are there are documented instructions in place for
acceptance or rejection of primary samples?
5.4.8
Where compromised primary samples were accepted,
was this stated on the final report and is there a
procedure in place for this?
When samples are split, how are the spilt portions
traced back to the primary sample?
5.4.12
EXAMINATION PROCEDURES
Are recognised methods used for these tests?
5.5
5.5.1
If in-house procedure were used, was the validation
carried out as per procedure and was the validation
approved and the test approved for the intended use?
Validations records shall include the following but is
not limited to:
5.5.2
1. Validation procedure including acceptance
criteria;
2. Are the results that were obtained documented
and available?
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3. Who reviewed the records of the validations
and approved the procedure for the intended
use?
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5.5.2
4. Did the performance specifications for each
procedure relate to the intended use of that
procedure?
If there are any deviations on the instruction for use
written by the manufacturer, was this reviewed,
validated and documented?
5.5.3
Is there an inventory control system for supplies and
did it include the recording of lot numbers of all
relevant reagents, control materials and calibrators,
the date of receipt and the date the material was
placed in service?
4.6.3
Did the documented procedures/instructions available
for all tests include , where applicable:
a) The purpose of the examination;
5.5.3
5.8.11
5.4.3 d)
b) The principle of the procedure;
c) Performance specifications including
uncertainty of measurement;
d) Primary sample;
e) Type of container and additives;
f) Required equipment and reagents;
g) Calibration procedures;
h) Step by step instructions;
i) Quality Control procedures;
j) Interferences (e.g. lipemia, hemolysis etc);
k) Principle for calculating results, including
measurement uncertainty;
l) Biological reference interval;
m) Patient reference ranges;
n) Alert/critical values, where appropriate;
o) Laboratory interpretation;
p) Safety precautions (PPE, available and used);
q) Potential sources of variability;
r) Required calibrators and controls;
s) The storage and preparation of materials;
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t) The source of method e.g. literature
references, manufacturers, leaflets etc.;
u) Turnaround times for examination;
5.5.3
5.8.11
5.4.3 d)
(cont.)
v) The storage conditions for specimens;
w) Time limits for additional requests;
x) Repeat examinations due to analytical failure.
LABORATORY EQUIPMENT
Note: All Instruments, reagents, consumables and analytical systems are included under this heading. 5.3
What equipment was used to perform the tests?
5.3.1
If the equipment used was outside the permanent
control of the laboratory, how did management
ensure that the requirements of this standard were
met?
Is a programme and standard operating procedure
available for monitoring in-service checks and
calibrations performed on all equipment in the
laboratory, and was this done?
5.3.2
How was the equipment uniquely labelled /
otherwise identified?
5.3.3
Are records for each item of equipment
maintained?
5.3.4
Do the records include the following:
a) Identity of the equipment;
b) Manufacturer’s name, type identification, and
serial number or other unique identification;
c) Manufacturer’s contact person and telephone
number;
d) Date received and date placed in service;
e) Current location, where appropriate;
f) Condition when received (e.g., new, used,
reconditioned);
g) Manufacturers instructions, if available, or
reference to their retention;
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h) Performance records that confirm the
equipments continued suitability for use (should
include reports/certificates of all calibrations
and or verifications including dates, time and
results, adjustments, the criteria and due date
of the next calibration together with the
frequency of checks carried out between
maintenance /calibration).
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5.3.4
(cont.)
i) What maintenance was carried out to date and
what maintenance is planned for the future;
j) Are records of damage, malfunction,
modification or repair to the equipment
available?
k) Predicted replacement date, if possible.
Where are the operating manuals / standard
operating procedures or similar documents for all
relevant pieces of equipment stored and are they
readily accessible in the laboratory?
5.3.5
What functional and safety checks on instruments
are carried out and at what intervals?
5.3.6
Is there evidence that safety checks are
documented to detect trends or malfunctions?
Is defective equipment taken out of service and
suitably labelled?
5.3.7
What measures were taken to reduce contamination
of the equipment prior to servicing?
5.3.8
Where practicable, how is equipment labelled to
indicate the calibration or verification status?
5.3.9
How was the equipment checked for proper function
before being put to use after being out of the control
of the laboratory?
5.3.10
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When computers or automated equipment are used
for collection, processing, recording, reporting,
storage or retrieval of data, how did management
ensure that:
5.3.11
a) All software including that built into equipment
was validated and documented as adequate
for use;
b) Were procedures in place for protecting the
integrity of data at all times ;
c) Are computers and automated equipment
maintained and operated so as to ensure the
integrity of data ;
Does the laboratory have procedures for the safe
handling, transport, storage and use of equipment to
prevent its contamination or deterioration?
Where calibrations gave rise to a set of correction
factors, did the laboratory have procedures for
ensuring that copies of prior correction factors were
correctly updated?
5.3.13
ASSURING QUALITY OF EXAMINATION PROCEDURES 5.6
Are all aspects of specimen handling and testing
subjected to internal quality control procedures?
5.6.1
Where relevant and possible, has the uncertainty of
results for each procedure been determined?
(including sources which may influence results).
5.6.2
Is there a programme for calibration to verify
trueness of a result to ensure it’s traceable to a
reference? (eg: International References/ SI units)
5.6.3
Where calibration and verification is not possible,
are other means for providing confidence in the
results applied, which include but are not limited to
the following:
a) Participation in a suitable inter-laboratory
comparison programme?
b) Uses suitable reference material;
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c) Examines or calibrates by another procedure;
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5.6.3
(cont.)
d) Performs ratio or reciprocity-type
measurements;
e) Uses mutual consent standards or methods
which are clearly established;
f) Documents statements on traceability
supplied by the manufacturer or supplier.
What external quality assessment scheme ( formal
interlaboratory comparison programme ) does the
lab participate in?
5.6.4
How does laboratory management monitor the
results of external quality assessment and the
participation in the implementation of corrective
actions when control criteria is not fulfilled?
Is there evidence that the External Quality
Assessment programme provides clinically relevant
challenges that mimic patient samples and have the
effect of checking the entire examination process
including the pre-and post examination procedures?
If a formal interlaboratory comparison programme is
not available what mechanism has the laboratory
developed for determining the acceptability of
procedures not otherwise evaluated?
5.6.5
Are inter-laboratory results clearly documented and
monitored?
Are appropriate actions taken if external and/or
internal QC results are outside stated limits and are
these corrective actions recorded?
Is the type and frequency of external and internal
QC samples for each procedure clearly stated?
Where examinations are performed at different
sites, have correlation studies been performed, and
the data recorded?
5.6.6
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Where applicable, are Cause Analysis performed
and the appropriate preventative action(s)
implemented? Give examples.
4.10.1
Where adjustment factors had to be introduced as
a result of the correlation studies, was this done
timeously and the action recorded?
5.6.7
QUALITY & TECHNICAL RECORDS 4.13
Are all records legible and stored in a manner such
that they are readily retrievable?
4.13.2
(Note Records may be stored on any appropriate
medium subject to national, regional or local legal
requirements)
Do storage facilities provide an environment which
prevents damage, deterioration, loss or unauthorized
access?
Are any amendments made clearly marked, initialled
and dated?
4.3.2
(g)
Is it possible to establish an audit trail, by examining
raw data, records, covering all activities from the
receipt, identification and data input of samples, all
stages of the analytical process, its storage in the
laboratory and final disposal, and the issuing of the
final reports?
B1.5
Is a file available which contains hard copies of all
patient data? (results of tests and test process hard
copy)
B1.7
PERSONNEL
Were the examinations carried out by authorised and
competent personnel?
5.1.7
5.1
5.1.11
Are training & competency records of staff who
performed the tests available?
Are there records of relevant educational and
professional qualifications and current registration with
the relevant body?
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LABORATORY SAFETY, ACCOMODATION & ENVIRONMENTAL CONDITIONS 5.9
Is there sufficient space to perform work without
compromising the quality of work and safety of staff
and patients?
5.2.1
Are all isles and corridors free from obstruction?
5.2.4&5
Is the laboratory environment monitored and of such
a nature that it does not invalidate test results?
5.2.6
Are incompatible activities effectively separated from
one another?
5.2.7
Is access to, and use of, all areas affecting the quality
of test results are defined and controlled?
5.2.10 &
5.7.3
Does the laboratory monitor, control and record
environmental conditions ,as required by relevant
specifications or where they may influence the quality
of results? Attention should be paid to sterility, dust,
electromagnetic inetrefernce, radiation, humidity,
electrical supply, temperature and sound and
vibrations levels.
Are work areas clean?
Is storage and disposal of dangerous materials done
in a safe manner?
GENERAL/ADDITIONAL COMMENTS AND MATTERS TO FOLLOW UP AT NEXT ASSESSMENT
Signed:
Technical Assessor
Signed:
Lead Assessor
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