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 - IMMUNOLOGY
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:
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 1 of 11
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.
1.0
1.1
1.2
1.3
1.4
2.0
2.1
2.2
2.3
2.4
2.5
2.6
2.7
DETAILED CHECKLIST: IMMUNOLOGY CHECKLIST
REQUIREMENT
(Doc.
Ref. /
Clause
No.)
ASSESSMENT
COMPLIANCE
Y/N/NA
NOTES
QUALITY MANAGEMENT AND
QUALITY CONTROL
Does the laboratory follow manufacturer
instructions, where applicable?
Are control results documented for quantitative
and qualitative tests, as applicable?
Is there evidence of corrective action when
control results exceed defined acceptability
limits?
Are the results of controls verified for
acceptability before reporting results?
GENERAL ISSUES
Does the immunology laboratory have a
written quality management/quality control
(QM/QC) program?
Is there a documented procedure describing
methods for patient identification, patient
preparation, specimen collection and labelling,
specimen preservation, and conditions for
transportation, and storage before testing,
consistent with good laboratory practice?
Is there evidence of ongoing evaluation of
instrument function and maintenance,
temperature, etc.?
Is there documentation of corrective action
taken when values for instrument function,
temperature, etc., exceed defined tolerance
limits?
For numeric QC data, are statistics (such as
S.D. and C.V.) calculated at specified intervals
to define analytic precision?
Does the laboratory have an action protocol
when data from precision statistics change
significantly from previous data?
Is there a documented system in operation to
detect and correct significant clerical and
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 2 of 11
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
2.8
3.0
3.1
3.2
3.3
3.4
3.5
3.6
analytical errors, and unusual laboratory
results, in a timely manner?
In the absence of on-site supervisors, are the
results of tests performed by personnel
reviewed by the laboratory director or general
supervisor within 24 hours?
PROCEDURE MANUAL
Is a complete procedure manual available at
the workbench or in the work area?
Is there documentation of at least annual
review of all policies and procedures in the
immunology/syphilis serology laboratory
section(s) by the current laboratory director or
designee?
Does the laboratory director or designate
review and approve all new policies and
procedures, as well as substantial changes to
existing documents, before implementation?
If there is a change in directorship, does the
new director ensure (over a reasonable period
of time) that laboratory procedures are welldocumented and undergo at least annual
review?
When a procedure is discontinued, is a paper
or electronic copy maintained for at least 2
years, recording initial date of use, and
retirement date?
Does the laboratory have a system
documenting that all personnel are
knowledgeable about the contents of procedure
manuals (including changes) relevant to the
scope of their testing activities?
4.0
PERSONNEL
4.1
Does the person in charge of the technical
operations in immunology and syphilis
serology have relevant education and
experience?
5.0
PHYSICAL FACILITIES
5.1
5.2
Is there adequate space for administrative
functions?
Is there adequate space for clerical work?
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 3 of 11
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
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
5.12
5.13
5.14
5.15
5.16
6.0
6.1
6.2
6.2.1
6.2.2
6.2.3
6.2.4
6.3
6.4
6.5
6.6
Is there adequate space for technical work
(bench space)?
Is there adequate space for instruments?
Is there adequate space for shelf storage?
Is there adequate refrigerator/freezer storage
space?
Is the available space efficiently utilized?
Is sufficient space available so that there is no
compromise of the quality of work, (including
quality control activities) or safety of
personnel?
Are floors and benches clean, free of clutter,
and well-maintained?
Are water taps, sinks, and drains adequate?
Are electrical outlets adequate?
Is lighting adequate?
Is ventilation adequate?
Is temperature/humidity control adequate?
Is gas and suction adequate?
Are telephones conveniently located, and are
calls easily transferred?
REAGENTS
For waived tests, does the laboratory follow
manufacturer instructions for handling and
storing reagents?
Are reagents and solutions properly labeled, as
applicable and appropriate, with the following
elements:
Content and quantity, concentration or titer
Storage requirements
Date prepared or reconstituted by laboratory
Expiration date
Are all reagents used within their indicated
expiration date?
Are reagents stored as recommended by the
manufacturer?
Are new reagent lots and/or shipments checked
against old reagent lots or with suitable
reference material before or concurrently with
being placed in service?
Are the recommendations of the manufacturer
for the proper use of reagents and controls in
kit procedures followed?
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 4 of 11
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
6.7
6.8
7.0
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
Are common interferences evaluated for all
analytes measured with each reagent system,
or is credible information available from other
sources?
If there are multiple components of a reagent
kit, does the laboratory use only components
of reagent kits within the kit lot unless
otherwise specified by the manufacturer?
INSTRUMENTS AND EQUIPMENT
Is an appropriate thermometric standard
device of known accuracy (NPL/NISTcertified or guaranteed by manufacturer to
meet NPL/NIST Standards) available?
Are all non-certified thermometers in use in
the laboratory checked against an appropriate
thermometric standard device before being
placed in service?
Is the temperature of water baths and/or heat
blocks, refrigerators and other temperaturedependent equipment checked and recorded
appropriately?
Are mechanical timers on serologic
centrifuges, and the speed of the centrifuge,
checked for accuracy every 6 months?
Are function checks performed at specified
periodic intervals on all instruments?
Are all instruments on a routine maintenance
program?
Are instrument maintenance, service and repair
records (or copies) promptly available to, and
usable by, the technical staff operating the
equipment?
Are glass volumetric pipettes of certified
accuracy (Class A); or are they checked by
gravimetric, colorimetric, or some other
verification procedure before initial use?
Are non-class A pipettes that are used for
quantitative dispensing of material checked for
accuracy and reproducibility at specified
intervals, and results documented?
Is the use of less precise measuring devices
such as serological plastic pipettes and
graduated cylinders limited to situations where
the accuracy and precision of calibrated glass
pipettes are not required?
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 5 of 11
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
7.11
7.12
7.13
8.0
8.1
8.2
8.3
8.4
8.5
9.0
9.1
9.2
9.3
9.4
9.5
9.6
Are automatic and adjustable pipetting devices
checked at specified periodic intervals for
accuracy and reproducibility, and results
recorded?
Has the laboratory evaluated its automatic
pipetting systems for carryover?
Are glass volumetric flasks of certified
accuracy (Class A, National Institute of
Standards and Technology (NIST) standard or
equivalent), or if non-certified volumetric
glassware is used, are all items checked for
accuracy of calibration before initial use?
Analytic Balances
Are balances cleaned, serviced and checked
periodically only by qualified service
personnel (i.e., service contract or as needed)?
Are analytic balances mounted such that
vibrations do not interfere with readings?
Are standard weights of the appropriate
ANSI/ASTM/Equivalent Class available and
used for checking accuracy?
Are results of periodic accuracy checks
recorded?
Are weights well-maintained (clean, in a
covered container, not corroded) and are
appropriate lifting or handling devices
available?
CALIBRATION AND STANDARDS
For waived tests, do testing personnel follow
manufacturer instructions for calibration,
calibration verification, and related functions?
Are calibration procedures for each method
adequate, and are the calibration results
documented?
Are high quality materials with method- and
matrix-appropriate target values used for
calibration and calibration verification
whenever possible?
Are all calibration materials properly labelled
as to content and calibration values?
Do calibration materials include dates placed
in service and expiration dates?
Are criteria established for frequency of
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 6 of 11
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
9.7
9.8
9.9
9.10
9.11
10.0
10.1
10.2
10.3
recalibration or calibration verification, and
the acceptability of results?
Is the method system recalibrated when
calibration verification fails to meet the
established criteria of the laboratory?
Is validation of the analytical measurement
range (AMR) performed with matrixappropriate materials which include the low,
mid and high range of the AMR, and is the
process documented?
Are criteria established for validating the
analytical measurement range, and is
compliance documented?
Are results falling outside the AMR limits
reviewed and reassayed if necessary before
reporting?
Are dilution protocols and diluents (or
concentration protocols) specified for all
methods for which the CRR exceeds the
AMR?
SPECIMEN COLLECTION AND
HANDLING
Are procedures adequate to verify sample
identity and integrity (includes capillary
specimens, aliquots and dilutions)?
Are there documented criteria for the rejection
of unacceptable specimens and the special
handling of sub-optimal specimens?
Is the disposition of all unacceptable
specimens documented in the patient report
and/or quality management records?
11.0
PROCEDURES AND TEST SYSTEMS
11.1
BLOOD TYPE, GROUP, AND/OR
ANTIBODY SCREENS
11.1.1
11.1.2
Are package inserts for immunohematology
typing sera in use available, and are typing sera
used according to manufacturer's directions, or
if alternative procedures are used, have they
been evaluated to justify the changes?
Do records document acceptable reactivity and
specificity of typing sera and reagent cells on
each day of use, including a check against
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 7 of 11
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
11.1.3
11.1.4
11.1.5
11.1.6
11.1.7
11.1.8
11.1.9
11.1.10
11.2
11.2.1
11.2.2
11.2.3
known positive and negative cells or antisera,
or are manufacturer’s directions for daily
quality control followed?
Are criteria for agglutination and/or hemolysis
defined?
Are observations of all test results recorded
properly at the time done?
Are appropriate control(s) used for anti-D
testing?
Are ABO, Rh, and antibody screen test results
compared against the same tests performed
previously to detect discrepancies and identify
patients requiring specially selected units?
Are records available that document
investigation and reconciliation of all cases in
which ABO and Rh typing results were not in
accord with the patient's historical record?
When a direct antiglobulin test is ordered by a
patient's physician, does the test system allow
detection of RBC-bound complement as well
as IgG?
When performing an antiglobulin test with
anti-IgG or polyspecific antiglobulin reagents
are IgG-coated red blood cells used in all
negative antiglobulin tests?
When performing an antiglobulin test with
anti-C3 antiglobulin reagents, are C3-coated
red blood cells used in all negative antiglobulin
tests?
SYPHILIS SEROLOGY
If antigen is delivered by needles, is the
volume of delivery checked under each of the
following circumstances?
1. Each time a new needle is used
2. When control patterns cannot be reproduced
3. When the antigen drop does not fall cleanly
from the tip
Is a negative control, plus positive serum
controls of known titer or controls of graded
reactivity run each day of patient testing?
Are new reagent lots of antigen for VDRL,
RPR, TRUST (toluidine red unheated serum
test), and USR (unheated serum reagin) tests
checked in parallel with reference reagents to
verify that they are of standard reactivity?
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 8 of 11
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
12.0
12.1
12.2
12.3
12.4
12.5
12.6
12.7
12.8
12.9
12.10
12.11
12.12
12.13
CONTROLS
Are controls run daily for quantitative and
qualitative tests?
For quantitative tests, has a valid acceptable
range been established or verified for each lot
of control material?
Are controls properly labelled as to content, lot
number, date of preparation and expiration
date?
Are reactive, weakly reactive and nonreactive
controls all used in test systems where results
are reported in that fashion?
Are there records to reflect the results of all
control procedures?
Is there documented evidence of corrective
action taken when results of controls exceed
defined acceptability limits?
Are control specimens tested in the same
manner and by the same personnel as patient
samples?
Are the results of controls verified for
acceptability before reporting results?
Are quality control data reviewed and assessed
at least monthly by the laboratory director or
designee?
Are all histochemical stains checked for
intended reactivity each day of use?
Are positive and negative controls included
with each patient run for all fluorescent or
enzyme antibody stains?
If the laboratory performs test procedures for
which calibration or control materials are not
commercially available, have guidelines been
established to verify the accuracy of patient
test results?
If the laboratory uses more than one method
to test for a given analyte, are the methods
checked against each other at least twice a
year for correlation of patient/client results?
13.0
PROFICIENCY TESTING
13.1
Does the laboratory’s activity for which
accreditation is sought / under accreditation
accurately reflect the testing performed?
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 9 of 11
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
13.2
13.3
13.4
13.5
13.6
13.7
14.0
14.1
14.2
Does the laboratory participate in the
appropriate required proficiency testing (PT)
/External quality assessment program accepted
by ACCAB for the patient testing performed?
If the tests do not require PT or is not available
or not economically viable, does the laboratory
exercises an alternative performance
assessment system for determining the
reliability of analytic testing?
Does the laboratory integrate all proficiency
testing samples into the routine laboratory
workload as much as possible, and are those
samples analyzed by personnel who routinely
test patient samples, using the same primary
method systems as for patient samples?
Is there ongoing evaluation of PT and
alternative assessment results, with prompt
corrective action taken for unacceptable
results?
Is there a policy that prohibits interlaboratory
communication about proficiency testing
samples until after the deadline for submission
of data to the proficiency testing provider?
Is there a policy that prohibits referral of
proficiency testing specimens to another
laboratory?
RESULTS REPORTING
Are reference intervals (normal values)
established or verified by the laboratory for the
population being tested?
As appropriate, are all patient results reported
with accompanying reference (normal)
intervals or interpretations?
CRA-F-05-15189-S-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 10 of 11
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-12-IC
RD-00-01/07/2014
This report shall not be reproduced in part without the permission of ACCAB
Page 11 of 11