Serial Line No.
No.
1
1
174 & 175
Page
No.
Existing Text
Submission
9
Laboratories shall not
include tests which
areperformed too
infrequently as it does
not permit calculation
of imprecision
2
8
When a Contract
1.Inability to calculate imprecision
cannot be a reason for not
including a test in the accreditation
scope It still can be calculated. Just
that it needs 20 data points with a
Reference Material or a QC
material which can be generated
over a period of time when it can
be included in scope
2.Also if it is qualitative or
interpretative test, the question of
calculation of imprecision does not
arise
Hence it is suggested to include
any test irrespective of number of
requests received for a day or
month as quality needs to be
maintained by a lab even if it is a
single test result issued to a
patient This requirement can be
removed even for HP,CP & BM
studies
If it is still desired by NABL, A
number in terms of number
requests received per month or
per day can be given to define a
test as being “performed
infrequently” as it is g given for
HP,CP & BM in the line 176 & 177
It is not clear whether routine tests
141 to 145
Modified Text
Reference for
Modification
Nil
Serial Line No.
No.
2
174 & 175
Page
No.
10
Existing Text
Submission
Research Organisation
(CRO) is involved in
bioavailability &
bioequivalence141
studies, it can apply
under ISO/IEC 17025
accreditation. The
organisations involved
in clinical 142
diagnosis will be
included under ISO
15189 accreditation.
143
The tests performed
on the human tissues
in the blood bank,
tissue bank, stem cell
harvesting 144 and
manufacturing activity
will not be covered
under ISO 15189
It is unethical for a
laboratory accredited
for a particular
discipline to continue
to perform tests that
do not meet the
quality requirements
It is desirable that
those tests which do
not fulfil the
done in a stem cell harvesting
centre as part of stem cell
harvesting like blood culture, CD
counts, HIV antibody testing, CBC,
etc can be covered under ISO
15189:2012 More clarity in terms
of drafting is needed
Modified Text
Reference for
Modification
The following
sentence may be
deleted and
rephrased as
“It is unethical for
a laboratory
accredited for a
particular
discipline /
test(s)to claim
Nil
It can be clearly stated whether
tests done in blood bank of a
hospital as part of screening blood
for infectious disease & patient
testing can be included in the
scope of accreditation if the lab of
the same hospital applies for
accreditation
Although it is said as ‘desirable’
This line is contradictory to what is
said in line 192,193,194
Hence this may be removed
In such cases it is not possible for
labs to continually improve its
quality system by bring all tests in
scope over a period of time
Accreditation is all about continual
improvement An Accredited lab is
Serial Line No.
No.
3
157
Page
No.
9
Existing Text
Submission
Modified Text
requirements
anywhere from a pass mark to a
centum and is never 100% at any
time
Quality is a never ending journey
Also as long as the laboratory does
not claim accreditation for those
tests not accredited it is not
‘Unethical’ Hence the question of
ethics never arises and it is
suggested to remove the this
sentence and rephrase it
accordingly
Also a laboratory may still continue
to do some tests as part of clinical
work and for patient care
following good clinical lab
practices which cannot be
discontinued even if not
accredited as it may include them
under scope at a later date as part
CQI
accreditation for
test(s) or
discipline(s) not
accredited by
NABL .Appropriate
& suitable action
as per NABL bye
laws will be taken
against such
laboratory
management “
“If the laboratory
wants to continue
non accredited
tests as part of
clinical work or
patient care it can
still continue to
perform them
provided they
follow Good
Clinical Laboratory
Processes and
Internal and
External Quality
Control practices
Microbiology &
infectious diseases
serology
Tests relating to Non-infectious
diseases serology (tests like
CRP,ASO ANA done by
Reference for
Modification
Serial Line No.
No.
3
376
Page
No.
18
Existing Text
TABLE 2: Qualification
norms for authorized
signatories
Submission
immunoassay) are not addressed
Does it still come under this
department ?
More clarity is needed
1.MBBS with 3 years of experience
in a clinical lab, MSc with 5 or 7
years of experience were allowed
as authorised signatories for some
discipline and for specific tests in
earlier issue of NABL 112
document But It has been
removed from this document
The same can be continued
Also Suggested to include M.Sc
MLT with 5 or 7 years experience
as authorised signatory for
specific fields
And to include MD pathology for
Molecular Diagnostics
2.Also the PhD qualification
addresses only Medical
Microbiology or Medical
Biochemistry
However there are medical
universities who confer PhD
degrees in medical field but their
PhD degree certificates mentions
the degree as Basic Medical
Sciences or Biomedical sciences
Hence to include those PhD
degrees also as signatories
Modified Text
Reference for
Modification
NABL 112
earlier
Document
Serial Line No.
No.
Page
No.
Existing Text
376
18
TABLE 2: Qualification
norms for authorized
signatories
3
263 to 265
13
4
277 to 278
13
Director/ Chairman/
Head (howsoever
named) shall have
basic Medical
academic and
postgraduate
qualifications with
continuous medical
education and five
years of experience in
medical laboratory
NABL also allows
referral to eminent
individuals who have
extensively published
in indexed scientific
journals. Referral is
also allowed to some
central laboratories
Submission
Modified Text
MD(Path) who have competency
to handle the Infectious and Noninfectious Molecular diagnostics
have to be considered with
appropriate experience in the
Authorised signatory
The document does not address
Post Graduate degree given by
American Board and others such as
Royal College (England, Australia)
which are considered atleast equal
to MD or DNB
It is not clear whether chairman /
Nil
head of a hospital need to have
Medical Qualification at all or
Medical Degree with a PG
qualification in Laboratory field or
any medical field if the hospital has
a Lab Qualified person designated
as Lab Director
More clarity in this sentence is
needed
A lot of subjectivity on the part of
labs and assessors will arise in
deciding “eminent individuals” &
“Reputed Institutions”
5
Reference for
Modification
Nil
Serial Line No.
No.
Page
No.
Existing Text
(NCDC New Delhi, NIV
278 Pune, CCMB
Hyderabad etc.) or
other reputed
institutions.
For POCTs, the tests
can be applied for
accreditation under
respective discipline of
Medical testing
4
170,171
9
4.
170
9
Only trained &
authorised persons
shall perform POCT
5
2421
101
The results must be
concordant with those
from central lab and
....
Submission
A separate ISO standard is
available for POCT testing ISO
22870: 2006
Hence It is suggested thatPOCT
tests should not and cannot be
included under scope of
accreditation under the respective
discipline
POCT testing is meant to be done
at or near bed side and not in
central lab Hence It may be
mentioned “non laboratory staff
namely nursing staff, clinicians,
physician assistant can perform
such tests if they are trained in
performing the particular POCT
Many a time a concordant value
will not be obtained with central
lab method as regular venous
blood sample / another specimen
is never taken simultaneously to
be done in central lab
Also it becomes ‘subjective’ to say
what is concordant both by the lab
personnel and by assessors Hence
may be deleted
Modified Text
Reference for
Modification
NA
NA
Serial Line No.
No.
6
351,352
Page
No.
17
Existing Text
Submission
Modified Text
Large /Very Large
Laboratory shall have
atleast one full time
authorised signatory in
each discipline
NA
7
335
16
Turn Around Time
NA
NA
8
526,527
26
The temperature in all
chambers of
refrigerator and deep
freezer shall be
checked and records
maintained till next
assessment
It is not clear if an authorised
signatory is required for each
discipline even when the person is
authorised to sign reports for more
than one discipline as per the table
2.
For example if a lab has
Histopathology, Cytopathology,
Biochemistry, Hematology, Clinical
Pathology Can One MD pathology
sign for all departments or one
authorised signatory is required
for each department in such labs?
Definition for Turn Around Time
may be given whether it is from
the time of collection or from the
time of receipt esp for samples
received from outside labs or
collected outside the lab premises
in collection centres
Monitoring the temperature of all
chambers of all refrigerators daily
requires more thermometers and
is expensive and time consuming
If the lab can show evidence of
monitoring all chambers and
maintaining temperature within
specified range it would be
sufficient monitor different
chambers can be monitored on
different days and show
Reference for
Modification
NA
Nil
Nil
Serial Line No.
No.
Page
No.
9
531,532
26
10
716
33
11
1166,1167
49
Existing Text
Submission
maintenance of temperature
within acceptable range
Refrigerators and Deep In a medical lab all refrigerators
freezers requiring
are critical as reagents, chemicals,
critical and continuous samples, reference materials QC
temperature control
samples are stored The document
shall be fitted with 24x can mention “when a refrigerator
7 temperature
is considered critical”or specify
recorders
those freezers where Temperature
recorders are required For
example refrigerators where
extracted DNA /RNA or reagents of
molecular diagnostic tests,
cytogenetics can be considered
critical, Sub stock cultures of
Reference Organisms
The Laboratory shall
1. It may not be possible for
establish and display
stand alone labs to
critical limits for tests
establish critical alert
in consultation with
levels in consultation with
the clinicians
clinicians
2.This requirement was
addressed in ISO 15189: 2007
but has been removed ( not
given as a requirement) from
the 15189: 2012 version
Anti HIV Ab testing
In a hospital attached lab Consent
Written informed
for Anti HIV testing is taken by the
consent of the
referring physician and the
individual must be
consent goes into the medical
taken before the blood record of the patient .In such a
Modified Text
Reference for
Modification
Nil
Nil
Clause 5.9.1 a
& b of ISO
standard
15189:2012
and ISO
15189:2007
Sub Clause
5.8.8
Evidence of
counselling and
consent shall be
shown by the
laboratory
Serial Line No.
No.
12
1043 to
1045
13
14
Page
No.
45
44
681-684
31
Existing Text
Submission
sample is collected.
Evidence of
counselling and
consent shall be
retained by the
laboratory
case it will be difficult for the lab to
maintain the consent forms for
Anti HIV testing within the lab
However evidence of having taken
consent can be produced at the
time of audit.
Hence the draft can be modified
accordingly
It is not clear whether a separate
area or separate room is required
for media preparation in view of
space constraints for a lab in a
hospital attached lab or a small lab
carrying out basic C & S tests
Incompatible activities
shall be performed in
separate areas, e.g.,
the area for media
preparation shall be
different from that of
sample processing in
Microbiology.
Clinical Pathology
Clause 5.5
If the laboratory uses
more than one
measuring system
where the
The document does not address
automation in urine microscopy,
Automation in Seminal fluid
analysis &Body fluid analysis as
automation is increasingly used in
these tests
Suggested to include and address
the requirements for automated
seminal fluid counts and
microscopy, urine & body fluid
microscopy
It is not clear if method
comparison needs to be
undertaken if 2 similar instruments
from the same manufacturer using
Modified Text
Reference for
Modification
Nil
Can be changed
:”shall be
conducted atleast
once a year”
Serial Line No.
No.
Page
No.
1433,1434
58
1270
53
Existing Text
Submission
measurements are not
traceable to the same
reference material /
reference method, or
the biological
reference interval are
different, it is essential
to perform a
comparability study
between the systems
and prove that there is
agreement in
performance
throughout
appropriate clinical
intervals
Volume of workload
for each screener shall
be recorded. The
laboratory shall avoid
overloading the
screener
the same reagents, and calibrators
and controls are used
Also it is time consuming and
costly to perform twice a year
The examined
specimens shall be
stored for reexamination and/ or
additional tests for a
minimumperiod as
In view of space constraints in a
lab especially hospital attached lab
it is difficult to retain block and
slides for 10 years Hence
suggested to retain the older
requirement of 5 years for HP
It desirable that the workload can
be specified in terms of No of
slides per hour
Modified Text
Reference for
Modification
CLSI Standard says
12.5 slides per
working hour for
full manual review
(FMR) )if slides are
manually prepared
which works out to
100 slides / 8-hour
day
CLSI standard
and
www.fda.org/
medicaldevices
/safety/alertsa
ndnotices
Earlier version
of NABL 112
document
Serial Line No.
No.
Page
No.
1200
50
992-995
43
Existing Text
Submission
specified below:
Specimens – 30 days
Slides/ Blocks – 10
years
Sensitivity for those
antibiotics e.g.
vancomycin for S.
aureus, and colistin,
that cannot be
reported on the basis
of disc diffusion
method shall be
reported on the basis
of MIC testing based
on broth/ agar dilution
or automated systems,
or an E- test or
equivalent.
Biological Reference
Intervals (BRI) show
significant differences
with each lot of
reagent, type of
reagent, technique
and the instrument
used and should be
determined for each of
the situations if the
laboratory uses more
than one system. The
BRIstated in the
slides and blocks and specimens
for 15 days
Modified Text
Difficult to perform Disc Diffusion
Method for Vancomycin & Colistin
Sensitivity by medium and small
labs Hence may be deleted
Determination of BRI with each lot
of reagent is difficult as it requires
an elaborate study with a
minimum of 120 individuals (each
males and females) But Reference
Intervals given in product insert
can be verified for each new lot
Verification of reference intervals
using 20 apparently healthy
subjects is an accepted guideline
as per CLSI C28-A3 Third Edition
“Defining, Verifying, Establishing
Reference Intervals in a Clinical
Reference for
Modification
Nil
“ Should be
determined or
Verified”
CLSI Document
““Defining,
Verifying,
Establishing
Reference
Intervals in a
Clinical
LaboratoryApproved
Guideline C28 A23-third
edition
Serial Line No.
No.
Page
No.
1458 to
1685
5967
656 - 672
30 31
Existing Text
Submission
literature is unsuitable
for reporting the
prothrombin time
results.
Flow Cytometry
Laboratory-Approved Guideline
It can be carried out for any
analyte
Inter Laboratory
Comparison - Scheme
The document does not address
the requirements for Flow
Crossmatch offered by some
Transplantation Immunology Labs
Also the document does not
address HLA MultiplexMethod
PRA,DSA detection although it is
being done in some centres
The Term Reference Lab to be
defined more clearly
Modified Text
Reference for
Modification