ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
ON SITE ASSESSMENT REPORT
ISO 15189:2012 - Medical Laboratories –
Requirement for quality and competence
SUPPLEMENTARY CHECKLIST - SPECIALIZED TESTING
INSPECTION CHECKLIST
Part-I: GENERAL INFORMATION
ACCAB Reference No.:
Assessment Type:
Date(s) of Assessment:
Pre – Assessment
Initial Assessment
Re - Assessment
Extension of Scope
Short Notice Visit
On-site Clearance
Surveillance Visit
Re-Instatement Visit
Assessment Team:
Assessor / Technical
Expert(s)::
Persons Interviewed:
Laboratory Details:
Laboratory’s Name:
Address:
Country:
Telephone No.
Email address:
Principal Contact Name:
Postcode:
Fax. No.
Web Site:
Designation:
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
PART - II
CLAUSE
NO.
DETAILED CHECKLIST: SPECIALIZED TESTING
INSPECTION CHECKLIST
(Doc.
ASSESSMENT
Ref. /
COMPLIANCE
REQUIREMENT
Clause Y/N/NA
NOTES
No.)
1.0
QUALITY CONTROL
1.1
Test systems using only external controls:
Are two levels of external controls run each day
of use?
Test systems using internal controls:
Are internal controls run each day of use?
Has the laboratory validated the internal quality
control?
Are criteria established for frequency of
performing external quality control?
For quantitative tests, has a statistically valid
target range (mean, SD, CV) been established
for each lot of control material?
For qualitative tests that use a cut-off value to
distinguish positive from negative; is the cut-off
value established initially?
Are control specimens tested in the same
manner and by the same personnel as patient
samples?
Is quality control data reviewed at least monthly
by the laboratory director or designate?
Is this review documented?
Are results of controls verified for acceptability
before reporting results?
Are criteria for what is considered to be out of
control available to staff?
Are criteria for referral of “out of control”
results to the supervisor and/or senior staff
identified?
Is there documentation of corrective action
taken when controls exceed defined tolerance
limits?
Does the documentation include:
What was out of control?
Why the analysis was out of control?
Corrective action taken?
Signature/initials of individual responsible
Are control data organized and presented so
1.1.1
1.2
1.2.1
1.2.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
1.13.1
1.13.2
1.13.3
1.13.4
1.14
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
1.15
1.16
1.17
2.0
2.1
2.2
2.3
2.3.1
2.3.2
2.3.3
2.3.4
2.3.5
2.3.6
2.3.7
2.3.8
2.3.9
2.3.10
2.3.11
2.3.12
2.3.13
2.3.14
2.3.15
2.4
2.5
2.6
2.7
they can be evaluated daily by technical staff to
detect problems, trends, etc.?
Is lot number change of quality control material
documented on the quality control record?
Are quality control records retained for at least
two years?
Is quality control statistics (i.e. SD and CV)
calculated at specified intervals to define
analytical imprecision?
PROCEDURE MANUAL
Is a current procedure manual available for
laboratory staff?
Is the procedure manual maintained as per the
documented procedure ?
Are the following included for each procedure:
(if applicable)
Purpose
Specimens (type, source, amount, storage)
Equipment and Materials required
Preparation and storage of reagents, standards
and controls
Procedure – including Step by step instructions
Directions for calibration
Derivation of results (ie. mathematical
calculations, dilutions)
Quality control
Linearity limits
Precision
Reference ranges
Clinical Significance
Critical values
Reporting results (units, stats, critical values)
Safety
Is there documentation of annual review of the
procedure manual by the laboratory director or
designate?
Is there documentation of annual review of the
procedure manual by the laboratory staff?
Are all changes in methodology signed and
dated by whoever made the changes?
Are all new procedures reviewed by the
medical director or designate?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
2.8
2.9
2.10
3.0
3.1
3.2
3.2.1
3.2.2
3.2.3
3.2.4
3.3
4.0
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
4.2.7
4.2.8
4.3
Are discontinued procedures retained for two
years after the procedure is taken out of
service?
Is there a current file on manufacturer’s inserts?
Are there adequate and up to date reference text
books available to laboratory staff?
SPECIMEN COLLECTION MANUAL
Is a specimen collection manual available at all
collection sites?
Does the specimen collection manual include:
Patient preparation
Specimen type and amount (ie. midstream)
Proper handling (ie. preservative/
anticoagulant)
Labelling with patient first and last name and
personal health number
Are there written criteria for specimen
rejection?
REQUISITIONS
Are all specimens accompanied by an adequate
requisition?
Does the requisition include:
Adequate patient identification – name and
other identification
Ordering physician or authorized person
ordering the test
Date of birth and gender
Date and time of collection
Tests requested
Source of specimen
Clinical information, history or clinical
diagnosis, when appropriate
Accession number
Is the date and time that the specimen was
received by the laboratory recorded?
5.0
REAGENTS
5.1
5.2
Are all reagents used within their expiry date?
Are all reagents labelled with:
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
5.2.1
5.2.2
5.2.3
5.2.4
5.3
5.4
5.5
5.6
6.0
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
Date of receipt
Date prepared or opened
Expiry date
Content and concentration
Are all reagents stored according to
manufacturer’s instructions?
Are common interferences evaluated for all
analytes measured with each reagent system or
is credible manufacturer’s information
available?
If there are multiple components of a reagent
kit, does the laboratory use components of
reagent kits only within the same kit lot, unless
otherwise specified by the manufacturer?
Prior to use, are new reagent lots checked
against old reagent lot?
INSTRUMENTS AND EQUIPMENT
Is there a procedure for maintenance of all
instruments and equipment?
Are the maintenance records reviewed by a
supervisor?
Is this review documented?
Are there instructions for troubleshooting?
Are service records maintained for the life of
the instrument, plus two years?
Is there emergency power for instruments and
equipment?
Are instruments equipped with surge
protection? (this also includes computers)
If the laboratory uses more than one instrument
/method to test for a given analyte, are the
instruments/methods checked against each other
at least twice a year for correlation of results?
Are there defined tolerance limits for result
agreement of inter-instrument assays?
Does the laboratory have a procedure for
evaluating automatic pipette systems for
carryover?
Are pipettors and dilutors (fixed volume or
adjustable) checked at least annually for
accuracy and reproducibility, and results
recorded?
Is the temperature of water baths and/or heat
blocks checked on days of use?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
6.13
6.13.1
6.13.2
6.13.3
6.14
6.15
6.16
6.17
6.17.1
6.18
6.18.1
6.18.2
6.18.3
6.18.4
6.19
6.19.1
6.19.2
6.20
6.20.1
6.20.2
6.20.3
6.21
6.21.1
6.22
6.22.1
6.23
6.23.1
7.0
Is the temperature of refrigerators and other
temperature dependent equipment documented
daily:
Room temperature
Freezer
Refrigerator
Is there evidence of active review of results of
instrument maintenance and temperature?
Is there a procedure available if acceptable
temperature ranges are exceeded?
Is this review documented?
Glassware
Are there appropriate documented procedures
for handling and cleaning glassware, including
methods for testing for detergent removal?
Microscopes
Are there an adequate number of microscopes
for the workload?
Are all microscopes clean, well maintained and
suitable for their intended use?
Is there an adequate selection of objective
lenses for the specimens examined?
Is there a procedure for Koehler illumination?
Centrifuges
Is there a schedule for maintenance of all
centrifuges?
Are operating speeds checked and documented?
Balances
Are balances mounted on vibration-free
benches?
Are balances clean and regularly serviced?
Are NIST reference weights available and used
for checking accuracy?
Autoclaves
Is the autoclave monitored weekly for proper
functioning?
Pipettes
Does your laboratory check pipettes for
calibration?
Thermometers
Are certified thermometers used in the
laboratory?
TESTING
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
7.1
7.1.1
7.1.2
7.1.3
7.1.4
7.2
7.2.1
7.2.2
7.2.3
Calibration- is the set of operations that
establish, under specified conditions, the
relationship between reagent system and the
corresponding concentration value of an
analyte.
Are criteria established for frequency of
calibration?
Is there documentation of calibration for each
analyte?
Are calibrators that have method and matrix
appropriate target values used?
Does your laboratory verify the calibration?
Linearity – is the range of analyte values that a
method can directly measure on the specimen
without any dilution, concentration, or other
pre-treatment not part of the usual assay
process.
Is linearity of the instrument validated initially
and thereafter every six months?
Is there documentation of linearity?
Is there a procedure in place to ensure correct
results are reported if the result falls outside of
linearity?
8.0
SPECTROPHOTOMETERS
8.1
8.2
Is linearity checked at least annually?
Is this documented?
Is absorbency checked periodically with filters
or standard solutions, if required by the
instrument manufacturer?
Are filters visually inspected annually?
Is wavelength calibration checked at least
annually?
Is stray light checked at least annually?
Is this documented?
Are calibration curves verified bi-annually for
procedures as well as after servicing or
recalibration of the instruments?
Is this documented?
8.3
8.4
8.5
8.6
8.7
8.8
8.9
9.0
ATOMIC ABSORPTION
SPECTROPHOTOMETERS
9.1
Are the following maintenance procedures
performed daily, prior to sample analysis:
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
9.2.3
Aligning the burner head along the light path
Flushing aspirator and burner with water
Verify and record the lamp energy
Are the following maintenance procedures
performed weekly:
Clean the aspirator and line
Check, adjust and record the flow rate using
water as a sample
Clean burner, chimney and optical surface
10.0
RADIOIMMUNOASSAYS
9.1.1
9.1.2
9.1.3
9.2
9.2.1
9.2.2
10.1
10.2
10.3
10.4
11.0
11.1
11.2
11.3
11.4
12.0
12.1
12.2
12.3
Are gamma counters or scintillation counters
calibrated, results recorded and compared to
previous values each day of use?
Is background radioactivity determined each
day of use, including the background in each
well of multi-well counter?
Are there documented criteria for acceptable (or
unacceptable) background levels?
Are counting times sufficiency long for
statistical accuracy and precision?
THIN LAYER CHROMATOGRAPHY
(TLC)
Are appropriate standards, calibrators and
controls included with each TLC batch plate?
Is a control extracted and run through the entire
procedure for each run?
Are negative and positive controls extracted and
run through the entire procedure at least once a
week?
Are solvents prepared fresh as needed or if a
commercial kit is used, are the manufacturer’s
instructions followed?
HIGH PERFORMANCE LIQUID
CHROMATOGRAPHY (HPLC)
Are calibrators or standards run with each
analytic batch?
Are controls extracted and run through the
entire procedure?
If a hydrolysis step is required, does the
laboratory include a control?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
12.4
12.5
12.6
12.7
13.0
13.1
13.2
13.3
13.4
13.5
13.6
13.7
13.7.1
13.7.2
13.7.3
13.7.4
13.8
14.0
14.1
14.2
14.3
14.4
Are new columns verified for performance
before use?
Is there a criteria established for monitoring the
performance of the column and detector on
each day of use?
Is there a procedure for the detection of
potential carryover?
Is instrument performance (ie. retention times,
detector response) checked after major
instrument maintenance?
GAS CHROMATOGRAPHY (GC)
Are calibrators or standards run with each
analytic batch?
Are controls extracted and run through the
entire procedure?
If a hydrolysis step is required, does the
laboratory include a control?
Is there a procedure for detection and
evaluation of potential carryover?
Are new columns verified before use?
Is there criteria established for monitoring the
performance of the column and detector on
each day of use?
Are the following maintenance procedures
performed on each day of use:
Tank pressure
Flow rates
Septum changes
Column changes
Are gas lines checked regularly for leaks?
MASS SPECTROMETRY (MS)
Are mass spectrometers tuned each day of
patient testing or according to manufacturer’s
recommendations?
Are tune records maintained?
Are the identification criteria for single stage
mass spectrometry (ie. CG/MS, LC/MS) in
compliance with recommendations?
Do the identification criteria for tandem mass
spectrometry (MS/MS) comply with
recommendations?
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
14.5
14.6
14.6.1
14.6.2
14.7
14.8
14.9
14.10
14.11
15.0
15.1
15.1.1
15.1.2
15.1.3
15.1.4
15.1.5
15.1.6
15.1.7
15.1.8
15.2
15.3
15.4
15.5
Does the laboratory’s assay procedure for
LC/MS include an evaluation for possible ionsuppression?
Are mass spectrometric identification
performed by:
Selected Ion Monitoring (SIC)
Total Ion Current (TIC)
Where applicable, are TIC identification criteria
based on retention time and MS Library?
Are SIM spectra identification criteria based on
retention time?
Is there documentation indicating the precision
of each assay around the cut-off?
Is there evidence that the limit of detection
(sensitivity) and the linearity for quantitative
methods has been determined for each
procedure?
Are there criteria for the detection of potential
carryover?
MATERNAL SCREENING
Do the requisitions contain the following
information:
Collection date
Last menstrual period (LMP) or estimated
gestational age by ultrasound
Maternal birth date
Patient race
Maternal weight
History of insulin-dependent diabetes mellitus
Clinical evidence of multiple gestations
Initial screening sample or a repeat test for this
pregnancy
Is there documentation that the laboratory has
established its own median values or verified
that the manufacturer’s package insert or other
source of medians is appropriate for the
population being screened?
Are medians recalculated or re-verified at least
annually?
Are the percentages of women with screenpositive test results for both neural tube defects
and Down’s Syndrome calculated and reviewed
at least quarterly?
If calculations are performed on a computer is
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ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
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Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
15.6
15.6.1
15.6.2
15.6.3
15.6.4
15.6.5
15.6.6
15.6.7
15.6.8
15.6
15.7
15.8
15.9
15.10
15.11
15.12
15.13
15.14
16.0
16.1
16.2
there documentation that these calculations
were initially verified for accuracy and reverified with any software updates or change?
Is the following information included in the
report:
Date of birth
Maternal weight
Maternal race
First day of last menstrual period or gestational
age as determined by ultrasound examination
Specimen draw date
Initial or repeat specimen
Presence of insulin dependent diabetes
Presence of multiple gestation
Are test results reported as multiples of the
median (MoM)?
Does the report classify a pregnancy as screenpositive or screen-negative for open neural tube
defects, based on the maternal screen test
results?
Does the report classify a pregnancy as screenpositive or screen-negative for fetal Down’s
Syndrome, based on the calculated risk?
If an amniotic fluid sample has an elevated AFP
MoM is the fluid checked for fetal blood
contamination?
Is at least one amniotic fluid dilution control
processed with each analytic run of amniotic
fluids
Is acetylcholinesterase (AChE) testing
performed on all amniotic fluids having
elevated AFAFP concentration?
If no, explain what samples are not tested for
AChE:
If AChE is run in-house, are both positive and
negative controls included with each analytic
run?
If AChE is run in-house, are positive results
confirmed by addition of a specific inhibitor?
NEWBORN SCREENING
Is the newborn screening program monitored to
ensure 100% screening?
Is collection of sample required before
discharge?
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Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
16.3
16.4
16.5
16.6
16.6.1
16.7
16.8
16.8.1
16.8.2
16.8.3
16.9
16.10
16.11
17.0
17.1
17.2
17.3
17.4
17.5
17.6
17.7
17.8
17.9
17.10
Is transit time to the laboratory monitored?
Are delayed samples tested?
What is the number of delayed samples each
month?
Are unsatisfactory samples analyzed?
If yes, please explain:
What is the number of NSQ/ unsatisfactory
samples each month
Is a repeat screen requested for:
All abnormal results
Early discharge from hospital
Data omission
What is the number of delayed re-screens each
month?
Is there monitoring to ensure collection of all
repeat samples?
Is there a registry of abnormal results?
SWEAT TESTING FOR CYSTIC
FIBROSIS
Is the sweat test offered only to patients at an
appropriate age?
Does the testing protocol require a sweat
stimulation and collection from the patient’s
lower arm or upper leg, using a site that is free
from diffuse inflammation or rash?
Does the procedure specify the conditions of
iontophoresis?
Does the procedure specify that iontophoresis is
withheld from patients receiving oxygen by an
open delivery system?
Does the procedure specify that the area of
iontophoretic stimulation is equivalent to the
area of sweat collection?
Does the procedure specify the parameters of
sweat collection?
Does the procedure specify that multiple
insufficient sweat samples are rejected and not
pooled for analysis?
Does the laboratory report indicate the analytes
measured in the sweat analysis and the
reference ranges?
If the test performed is a screening test, is it
indicated on the report?
If the test performed is a confirmatory test, is
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17.11
18.0
the upper limit of reportable sweat chloride
results less than or equal to 160 mmol/L?
Are the personnel performing sweat test
collection and analysis trained to ensure
proficiency with collection and analysis
procedures?
PROFICIENCY TESTING
18.8
Proficiency Testing (PT) – a program where
multiple samples are periodically sent to a
group of laboratories for analysis and/or
identification, where each laboratory’s results
are compared with those of other laboratories in
the group and/or with an assigned value.
Is the laboratory enrolled in an external PT
program?
For analytes where graded PT is not available,
is there an alternative assessment procedure in
place?
Is alternative assessment performed twice a
year and documented?
Does the laboratory integrate all PT samples
within the routine workload?
Are PT samples analyzed by personnel who
routinely test patient samples?
Is there documentation of corrective action of
unacceptable PT results?
Is there documented evidence of review by the
laboratory director or designate of the external
PT results?
Are PT survey results retained for two years?
19.0
REPORTS
18.1
18.2
18.3
18.4
18.5
18.6
18.7
19.1
19.1.1
19.1.2
19.1.3
19.1.4
19.1.5
19.1.6
19.1.7
19.1.8
Do the report forms include:
patient name and other identification
physician or authorized person ordering test
date and time of specimen collection
test result(s) and units of measurement (when
applicable)
reference values
date and time of report release
conditions of specimen that may limit adequacy
of testing
name of laboratory performing the test(s)
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E-Mail: info@accab.org Website: www.accab.org
19.1.9
19.1.10
19.2
19.3
19.4
19.5
19.5.1
19.5.2
19.5.3
19.5.4
19.6
19.7
19.8
19.9
19.10
19.11
19.12
19.13
19.14
19.15
19.16
specimen source
specimen collected by
Are there established criteria for immediate
notification of critical test results?
Is there documentation of notification to the
proper clinical individual of results of all
critical values?
Does the laboratory have a policy regarding
“read back” of critical values that are
communicated verbally or by phone?
Is confidentiality ensured for laboratory results
received and distributed by the laboratory via:
Fax
Electronic Mail
Mail
Delivery
Is there a procedure to identify and trace
late/lost reports?
Is there a policy for retention of patient reports?
Does the laboratory promptly notify clinical
personnel and issue a corrected report when
errors are detected in patient test reports?
Is there a documented system to ensure that all
revised reports for previously reported incorrect
patient results are identified as amended on all
forms of patient reports?
Is there a policy regarding the communication
and documentation of reportable diseases?
Are all patient results reported with reference
ranges?
Are reference ranges verified or established by
the laboratory for the population being tested?
Is there a stat list in place?
Are stat results available within a reasonable
time?
Are routine results available within a reasonable
time?
Is the referral laboratory identified on the final
report, if specimens are referred out?
CRA-F-05-15189-S-05-STIC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 14 of 15
ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES
Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: info@accab.org Website: www.accab.org
Bibliography:
FAIR USE ACT 1976 NOTICE: This document may contain copyrighted material the use of
which has not always been specifically authorized by the copyright owner. such material is
made available to advance understanding of political, human rights, economic, scientific,
moral, ethical, and social justice issues. this constitutes a 'fair use' of any such copyrighted
material as provided for in section 107 of the 1976 us fair use copyright act. in accordance
with title 17 U.S.C. section 107, this material is distributed without profit, to those who have
expressed a prior general interest in receiving similar information for research and
educational purposes. In the event that any content of this checklist causes harm/unlawful
use/loss/unhappiness to anyone, the same should be brought to the notice of Accreditation
Commission For Conformity Assessment Bodies Private Limited, Mumbai India
info@accab.org
1. College of Physicians & Surgeons of Saskatchewan
2. College of Physicians & Surgeons of Alberta
3. Various other internet sources.
CRA-F-05-15189-S-05-STIC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 15 of 15