EPA
NATIONAL
LEAD
LABORATORY
ACCREDITATION
PROGRAM
LABORATORY
QUALITY
SYSTEM
REQUIREMENTS
(
LQSR)
REVISION
3.0
(
August
5,
2005
draft)

The
requirements
in
this
document
apply
to
all
lead
testing
laboratories
participating
in
the
Environmental
Protection
Agency's
(
EPA)
National
Lead
Laboratory
Accreditation
Program
(
NLLAP).
In
addition
to
meeting
the
Laboratory
Quality
System
Requirements
(
LQSRs),
the
lead
testing
laboratory
must
also
successfully
participate
in
the
Environmental
Lead
Proficiency
Analytical
Testing
(
ELPAT)
Program.

NLLAP
was
established
by
the
EPA
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
under
the
legislative
directive
of
Title
X,
the
Lead­
Based
Paint
Hazard
Reduction
Act
of
1992
Sections
405
(
a)
and
(
b)
requiring
EPA
to
set
minimum
standards
for
laboratory
analysis
of
lead
in
paint
films,
soil
and
dust.

Concerning
any
future
revisions
to
the
NLLAP
Laboratory
Quality
System
Requirements,
laboratories
currently
participating
in
NLLAP
will
be
given
a
period
of
twelve
months
from
the
posting
of
the
revision
on
the
http://
epa.
gov/
lead/
nllap.
htm
to
conform
to
any
new
requirements
stated
in
the
revision.
For
further
information
concerning
NLLAP,
please
address
your
request
in
writing
to:

Oksana
Pozda
U.
S.
Environmental
Protection
Agency
Ariel
Rios
Building
(
7404T)
Office
of
Pollution
Prevention
and
Toxics
1200
Pennsylvania
Ave.,
N.
W.
Washington
D.
C.
20460
NLLAP
LQSR
Rev.
3.0
8/
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DRAFT
iii
TABLE
OF
CONTENTS
1.0
SCOPE
1.1
Laboratory
Types
2.0
NORMATIVE
REFERENCES
3.0
TERMS
AND
DEFINITIONS
4.0
MANAGEMENT
REQUIREMENTS
4.1
ORGANIZATION
AND
MANAGEMENT
4.1.1
Technical
Manager
4.1.1.1
Qualifications
4.1.1.2
Responsibilities
4.1.2
Quality
Manager
4.1.2.1
Qualifications
4.1.2.2
Responsibilities
4.2
MANAGEMENT
SYSTEM
4.2.1
Management
System
Establishment
and
Maintenance
4.2.2
Quality
Policy
Statement
4.2.3
Management
System
Manual
4.3
DOCUMENT
CONTROL
4.3.1
General
4.3.2
Document
Approval
and
Issue
4.3.3
Document
Changes
4.3.4
Document
Review
and
Revision.
4.4
REVIEW
OF
REQUEST,
TENDER
OR
CONTRACT
4.5
SUBCONTRACTING
OF
TESTS
4.6
PURCHASING
SERVICES
AND
SUPPLIES
4.6.1
Reagents
and
Standards
4.6.1.1
Reagent
Grades
Used
4.6.1.2
Reagents
and
Standards
Tracking
4.7
SERVICE
TO
THE
CUSTOMER
4.8
COMPLAINTS
4.9
IMPROVEMENTS
4.10
CONTROL
OF
NONCONFORMING
TESTS
4.11
CORRECTIVE
ACTION
4.11.1
General
4.11.2
Cause
Analysis
4.11.3
Corrective
Actions
4.11.4
Monitoring
the
Corrective
Actions
4.11.5
Special
Audits
NLLAP
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iv
4.12
PREVENTIVE
ACTION
4.13
RECORDS
4.13.1
Sample
Records
4.13.2
Laboratory
Management
System
and
Test
Records
4.13.3
Electronic
Data
obtained
4.14
INTERNAL
AUDITS
4.15
MANAGEMENT
REVIEWS
5.0
TECHNICAL
REQUIREMENTS
5.1
GENERAL
5.2
PERSONNEL
5.2.1
Analysts/
Technicians
5.2.1.1
Minimum
Qualifications
and
Training
for
Analyst/
Technician
Personnel
5.2.1.2
Additional
Requirements
for
Mobile
and
FSMO
Personnel
5.3
ACCOMMODATION
AND
ENVIRONMENTAL
CONDITIONS
5.3.1
Contamination
Control
5.3.1.1
Laboratory
Dust
Wipe
Checks
5.3.1.2
Labware
Cleaning
5.4
TEST
AND
SAMPLING
METHODS
5.4.1.
Acceptable
Methodology
5.4.2
Method
Validation
and
Performance
Demonstration
Procedures
5.4.3
Sample
Preparation
and
Analysis
Procedures
5.4.3.1
Standard
Operating
Procedures
5.4.4
Method
Performance
Characteristics
5.4.4.1
Method
Detection
Limits
5.4.4.2
Quantitation
and
Reporting
Limits
5.4.4.3
Accuracy
and
Precision
5.4.5
Sample
Aliquots
5.4.6
DATA
REDUCTION
AND
REVIEW
PROCESS
5.5
EQUIPMENT
5.5.1
Instrument
Calibration
and
Performance
Quality
Checks
5.5.2
Instrument
Calibration
Performance
Requirements
5.5.2.1
Initial
Calibration
5.5.2.2
Independent
Calibration
Verification
5.5.2.3
Continuing
Calibration
Verification
5.5.2.4
Continuing
Calibration
Blank
(
CCB)
5.6
MEASUREMENT
TRACEABILITY
5.6.1
Reference
Standards
and/
or
Reference
Materials
5.6.2
Documentation
of
Reagent
and
Calibration
Solution
Preparation
5.7
SAMPLING
5.7.1
Sampling
Media
NLLAP
LQSR
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DRAFT
v
5.8
SAMPLE
HANDLING
5.8.1
Sample
Control
5.8.2
Sample
Acceptance,
Documentation
and
Tracking
Procedures
5.8.2.1
Sample
Acceptance
Policy
5.8.2.2
Sample
Receipt
Logs
5.8.2.3
Documentation
on
Questionable
Samples
5.8.2.4
Sample
Custody
Procedures
5.8.2.5
Sample
Tracking
5.9
ASSURING
THE
QUALITY
OF
TEST
RESULTS
5.9.1
Quality
Control
Procedures.
5.9.1.1
Bias
Determination
5.9.1.2
Precision
(
repeatability)
Determination
5.9.2
Control
Charts
or
Quality
Control
Data
Base
5.9.3
Procedures
for
determination
of
out
of
control
situations
5.10
REPORTING
THE
RESULTS
5.10.1
General
5.10.2
Test
Reports
5.10.2.1
Reporting
Results
Below
the
Quantitation
Limit
5.10.2.2
Opinions
and
Interpretations
5.10.3
REPORT
REVIEW
AND
APPROVAL
PROCESS
5.10.4
TEST
REPORT
CORRECTION
PROCESS
5.10.4.1
Corrections
and
Amendments
to
Test
Reports
5.10.4.2
Test
Results
Obtained
from
Subcontractors
5.10.4.3
Electronic
Transmission
of
Results
APPENDIX
I
Acronyms
Glossary
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
6
NATIONAL
LEAD
LABORATORY
ACCREDITATION
PROGRAM
(
NLLAP)

LABORATORY
QUALITY
SYSTEM
REQUIREMENTS
INTRODUCTION
AND
PURPOSE
This
document
identifies
the
minimum
requirements
for
use
by
accreditation
organizations
when
evaluating
laboratories
performing
environmental
testing
activities
under
NLLAP
and
is
based
on
requirements
of
International
Organization
for
Standardization
and
International
Electrochemical
Commission
(
ISO/
IEC)
Standard
17025:
2005
(
E)
"
General
requirements
for
the
competence
of
testing
and
calibration
laboratories".
NLLAP
recognizes
laboratories
that
perform
quantitative
and/
or
qualitative
analytical
testing
of
paint
chip
(
film),
dust,
and/
or
soil
samples
for
lead
analysis.
NLLAP
requires
recognized
laboratories
to
employ
quality
assurance/
quality
control
systems
that
meet
the
requirements
described
in
this
document,
to
monitor
for
potential
sample
matrix
and
environmental
interferences
as
well
as
laboratory
operational
deficiencies.

1.0
SCOPE
The
requirements
described
within
this
document
must
be
met
for
a
laboratory
to
attain
recognition
under
the
NLLAP
as
a
lead
testing
laboratory,
hereafter
referred
to
in
this
document
as
a
laboratory.
An
organization
requesting
recognition
under
this
program
shall
possess
a
laboratory
operation
capable
performing
sampling
and
lead
testing,
as
appropriate,
and
which
constitutes
an
identifiable
part
of
the
overall
organization.
A
laboratory
shall
have
distinct
staffing,
instrumentation,
sampling
and
test
methods,
as
appropriate,
and
depending
upon
the
type
laboratory
may
have
physical
facilities
and
may
use
field
test
kits.
Laboratory
accreditation
under
this
program
shall
be
based
on
its
meeting
the
requirements
listed
in
this
document.

1.1
Laboratory
Types
For
the
purposes
of
NLLAP,
a
laboratory
is
defined
as
an
operation
that
performs
sampling
and/
or
quantitative
and/
or
qualitative
analytical
testing
of
paint
chip
(
film),
dust,
and/
or
soil
samples
for
lead
analysis
regardless
of
the
number
of
personnel
or
the
extent
of
the
scope
of
testing
activities.

NLLAP
recognizes
three
types
of
laboratory
operations:
fixed­
site,
mobile
and
field
sampling
and
measurement
organization
(
FSMO).
These
types
of
laboratory
operations
are
defined
as
follows:

Fixed­
Site:
An
operation
that
performs
analytical
lead
testing
at
a
permanent
NLLAP
LQSR
Rev.
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DRAFT
7
location
under
controlled
environmental
conditions.

Mobile
Facility:
A
transportable,
self
contained
operation
that
can
perform
analytical
lead
testing
under
controlled
environmental
conditions.

Field
Sampling
and
Measurement
Organization
(
FSMO):
An
operation
that
performs
sampling
and
lead
testing
on­
site
that
is
under
evaluation
by
using
portable
testing
technologies.

A
laboratory
may
include
one,
two
or
all
three
of
these
types
of
operations.
In
cases
where
a
laboratory
does
not
perform
one
or
more
of
the
operations
addressed
above,
the
requirements
relating
to
those
activities
do
not
apply.

2.0
NORMATIVE
REFERENCES
The
following
normative
documents
were
used
in
the
writing
of
this
set
of
requirements.

NLLAP
LQSR
Rev.
2.0
08/
01/
96.

ISO/
IEC
Standard
17025:
2005
(
E)
"
General
requirements
for
the
competence
of
testing
and
calibration
laboratories".

40
CFR
Part
745
­
Lead­
Based
Paint
Activities.

Performance
Characteristics
Sheets,
available
at:
http://
www.
hud.
gov/
utilities/
intercept.
cfm?/
offices/
lead/
guidelines/
hudguidelines/
Allpcs.
pdf
3.0
TERMS
AND
DEFINITIONS
A
list
of
Acronyms
and
a
Glossary
of
Terms
used
in
this
document
is
in
Appendix
1.

4.0
MANAGEMENT
REQUIREMENTS
4.1
ORGANIZATION
AND
MANAGEMENT
The
laboratory
management
shall
accept
legal
responsibility
for
its
actions
and
ensure
that
appropriate
communication
processes
are
established
within
the
laboratory
so
that
communication
takes
place
regarding
the
effectiveness
of
the
laboratory
management
system.
In
addition,
policies
and
procedures
needed
to
ensure
that
management
and
personnel
are
free
from
any
conflicts
of
interest
that
might
adversely
affect
the
quality
of
work
performed
shall
be
NLLAP
LQSR
Rev.
3.0
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05
DRAFT
8
documented
and
implemented.
Procedures
shall
be
implemented
to
ensure
confidentiality
of
customer
information
and
protection
of
proprietary
rights.

The
laboratory
shall
have
job
descriptions
for
all
positions
and
an
organizational
chart
or
other
means
of
identifying
the
functions
of
key
personnel,
their
responsibilities,
lines
of
supervision,
and
authority.
Laboratory
management
shall
be
responsible
for
all
personnel
employed
by
the
laboratory
including
those
assigned
to
mobile
laboratories
and/
or
FSMOs
and
for
ensuring
that
its
personnel
are
aware
of
the
relevance
and
importance
of
their
activities
and
how
they
contribute
to
the
achievement
of
the
objectives
of
the
management
system.

The
laboratory
shall
also
appoint
one
member
of
the
staff
to
act
as
quality
manager.
The
quality
manager
shall
have
the
responsibility
and
authority
for
assuring
implementation
of
the
management
system
at
all
times.

All
NLLAP
recognized
laboratories
shall
identify
a
responsible
laboratory
official
who
is
authorized
to
release
test
reports
on
behalf
of
the
laboratory.
In
a
laboratory
with
one
person,
that
person
will
be
the
responsible
official
for
the
release
of
the
test
report.
That
same
person
may
serve
as
both
the
technical
manager
and
the
quality
manager.
Alternatively,
the
positions
of
technical
manager
and
quality
manager
may
be
contracted
out,
but
are
not
required
to
be.
See
Sections
4.14,
5.4.6
and
5.10.3
below
for
requirements
on
one­
person
firms
regarding
internal
audits
and
the
release
of
test
reports.

The
following
specific
personnel
requirements
shall
apply
to
NLLAP
recognized
laboratories.
In
laboratories
with
a
limited
number
of
personnel,
individuals
may
be
assigned
more
than
one
duty.

4.1.1
Technical
Manager
4.1.1.1
Qualifications
The
individual
who
functions
as
the
technical
manager
(
however
named)
of
the
laboratory
shall
have
appropriate
education,
training,
and
experience,
or
combination
thereof,
to
enable
that
individual
to
identify
the
occurrence
of
departures
from
the
implemented
management
system
or
test
procedures
and
to
initiate
actions
to
prevent
or
minimize
such
departures.

4.1.1.2
Responsibilities
The
technical
manager
or
their
designee
shall
be
responsible
for
all
technical
operations
and
shall
be
available
to
address
technical
issues
for
laboratory
staff
and
customers
concerning
NLLAP
related
analyses.
NLLAP
LQSR
Rev.
3.0
8/
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05
DRAFT
9
The
technical
manager
shall
ensure
and
document
the
competence
of
all
who
operate
specific
equipment,
perform
tests,
evaluate
results,
and
sign
test
reports.
The
competence
determination
shall
be
based
on
appropriate
education,
training,
experience
and/
or
demonstrated
skills.

The
technical
manager
shall
ensure
that
adequate
supervision
is
provided
for
all
laboratory
technical
personnel
and
shall
be
easily
accessible.

The
technical
manager
shall
ensure
that
mobile
and
FSMO
personnel
have
the
capability
to
communicate
with
their
supervisor
or
the
technical
manager
while
on
site
at
a
field
job
location.

4.1.2
Quality
Manager
4.1.2.1
Qualifications
The
individual
who
functions
as
the
quality
manager
(
or
however
named)
of
the
laboratory
shall
have
the
education,
training,
and
experience,
or
combination
thereof,
to
enable
that
individual
to
identify
the
occurrence
of
departures
from
the
implemented
management
system
and
to
initiate
actions
to
prevent
or
minimize
such
departures.
The
quality
manager
shall
be
knowledgeable
of
the
management
system
and
the
technical
and
management
system
procedures
used.

4.1.2.2
Responsibilities
The
quality
manager
shall
have
defined
responsibility
and
authority
to
implement
and
oversee
the
management
system,
implement
new
quality
assurance
and
control
practices,
perform
periodic
audits
of
the
management
system,
perform
periodic
review
of
test
reports
prior
to
issue,
and
to
ensure
laboratory
management
system
deficiencies
are
documented
and
that
corrective
actions
are
implemented.

4.2
MANAGEMENT
SYSTEM
The
laboratory
management
system
shall
include
all
the
policies
and
procedures
required
by
this
document
and
the
performance
of
the
activities
covered
by
its
scope
of
accreditation.
The
management
system
manual
(
MSM)
shall
contain
all
the
required
policies
and
must
either
contain
or
cite
the
related
quality
documentation
and
procedures
to
help
ensure
and
document
the
quality
of
the
analytical
data.

The
MSM
and
related
quality
documentation
shall
state
the
laboratory's
policies
and
NLLAP
LQSR
Rev.
3.0
8/
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05
DRAFT
10
operational
procedures
established
in
order
to
meet
the
requirements
of
this
document.

All
items
in
the
laboratory's
quality
system
shall
be
available
for
on­
site
inspection
or
audit
by
EPA
NLLAP
personnel
and
by
accreditation
organizations
participating
in
NLLAP
or,
if
applicable,
to
federal/
state/
tribal
program
certifying
officials.

Laboratory
management
shall:

a.
Provide
evidence
of
its
commitment
to
the
development
and
implementation
of
the
quality
system
and
continually
improving
the
effectiveness
of
the
management
system.

b.
Ensure
the
integrity
of
the
management
system
is
maintained
when
changes
to
the
quality
system
are
planned
and
implemented.

c.
Communicate
to
the
organization
the
importance
of
meeting
customer
as
well
as
statutory
and
regulatory
requirements.

4.2.1
Management
System
Establishment
and
Maintenance
The
laboratory
shall
establish
and
maintain
a
management
system
to
ensure
the
quality
of
its
testing.

a.
The
elements
of
this
system
shall
be
documented.

b.
The
quality
documentation
shall
be
available
for
use
by
laboratory
personnel.

c.
The
laboratory
management
shall
ensure
that
these
policies
and
objectives
are
documented
in
a
MSM
and
communicated
to,
understood,
and
implemented
by
laboratory
personnel.

d.
The
MSM
shall
be
reviewed
annually,
updated
as
needed
and
maintained
under
the
responsibility
of
the
quality
manager
(
or
however
named).

4.2.2
Quality
Policy
Statement
Laboratory
management
shall
define
and
document
the
objectives
and
policies
of
the
management
system.
These
policies
and
objectives
shall
be
documented
in
a
MSM.
The
overall
objectives
shall
be
provided
in
a
quality
policy
statement
in
the
MSM
that
denotes
the
standard
of
performance
to
be
obtained
and
maintained.
The
chief
executive
shall
issue
the
quality
policy
statement.
It
shall
include:
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a.
a
statement
of
the
standard
of
service
the
laboratory
management
intends
to
provide;

b.
the
purpose
of
the
management
system;

c.
a
requirement
that
all
personnel
involved
with
testing
activities
within
the
laboratory
acquaint
themselves
with
management
system
documentation
and
implement
the
policies
and
procedures
used
in
their
work;

d.
the
commitment
of
the
laboratory
to
good
professional
laboratory
practice
and
quality
of
service
to
the
customer;

e.
the
laboratory
management's
commitment
to
compliance
with
the
requirements
of
this
document.

4.2.3
Management
System
Manual
The
QM
shall
include
the
defined
roles
and
responsibilities
of
technical
management
and
the
quality
manager,
including
their
responsibility
for
ensuring
compliance
with
the
requirements
of
this
document.
The
management
system
shall
include
an
organizational
chart
identifying
key
personnel,
responsibilities,
lines
of
authority,
and
interrelationships
of
staff.
The
MSM
shall
include
or
make
reference
to
the
supporting
procedures
including
technical
procedures
and
shall
outline
the
structure
of
the
documentation
used
in
the
management
system.

The
MSM
and
related
quality
documents
shall
include
or
address
at
least
the
following
elements:

#
Title
Page
#
Table
of
Contents
#
Management
requirements
#
Organization
(
4.1)

#
Management
system
(
4.2)

#
Document
contro
l(
4.3)

#
Review
of
requests,
tenders
and
contracts
(
4.4)

#
Subcontracting
of
tests
and
calibrations
(
4.5)

#
Purchasing
services
and
supplies
(
4.6)

#
Service
to
the
customer
(
4.7)

#
Complaints
(
4.8)

#
Control
of
nonconforming
testing
and/
or
calibration
work4.9
#
Improvement
(
4.10)
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#
Corrective
action
(
4.11)

#
Preventive
action
(
4.12)

#
Control
of
records
(
4.13)

#
Internal
audits
(
4.14)

#
Management
reviews
(
4.15)

#
Technical
requirements
#
General
(
5.1)

#
Personnel
(
5.2)

#
Accommodation
and
environmental
conditions
(
5.3)

#
Test
and
calibration
methods
and
method
validation
(
5.4)

#
Equipment
(
5.5)

#
Measurement
traceability
(
5.6)

#
Sampling
(
5.7)

#
Handling
of
test
and
calibration
items
(
5.8)

#
Assuring
the
quality
of
test
and
calibration
results
(
5.9)

#
Reporting
the
results
(
5.10)

The
MSM
shall
be
updated
whenever
necessary
and
reviewed
and
approved
by
management
at
least
annually.
The
MSM
shall
be
accessible
to
all
laboratory
personnel.

4.3
DOCUMENT
CONTROL
4.3.1
General
The
NLLAP
recognized
laboratory
shall
establish
and
maintain
procedures
for
the
control
of
all
documents
(
both
internal
and
external
documents)
that
form
the
management
system.
Documents
included
may
be
external,
such
as
standards,
regulations,
normative
documents,
test
and/
or
calibration
methods,
drawings,
specifications,
instructions,
and
manuals.
The
laboratory
document
control
system
shall
ensure
that
all
standard
operating
procedures,
manuals,
and/
or
documents
clearly
indicate
the
time
period
during
which
the
procedure
or
document
was
in
force.

4.3.2
Document
Approval
and
Issue
All
documents
in
the
laboratory
shall
be
reviewed
and
approved
before
their
release
for
use
by
authorized
personnel.
A
system
shall
be
implemented
for
identification
of
the
current
revision
status
of
quality
system
documents
to
prevent
use
of
invalid
or
obsolete
documents.

Quality
system
documents
generated
by
a
laboratory
shall
be
clearly
identified.
Included
in
the
identification
shall
be
the
issue
date,
revision
identification
and
the
total
number
of
pages
or
a
clearly
marked
document
end.
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4.3.3
Document
Changes
Document
changes
shall
be
reviewed
by
the
same
personnel
that
reviewed
the
original
document,
unless
otherwise
indicated.
Where
possible,
changes
to
the
document
shall
be
noted
in
the
document
or
in
an
attachment.
Documents
may
be
amended
by
hand
pending
reissue
of
the
most
current
version,
where
permitted.
A
revised
document
shall
be
re­
issued
as
soon
as
practicable.

A
system
shall
be
established
and
used
to
record
changes
made
in
computerized
systems.

4.3.4
Document
Review
and
Revision.

The
laboratory
shall
outline
in
its
MSM
or
document
control
standard
operating
procedure
(
SOP),
the
process
used
in
the
adoption
and
revision
of
management
system
documents.
This
process
shall
address
when
and
how
the
laboratory's
documents
are
reviewed,
identify
the
sign
off
authority,
and
state
that
the
laboratory
documents
are
reviewed
at
least
every
two
years
and/
or
revised
as
needed.

4.4
REVIEW
OF
REQUEST,
TENDER
OR
CONTRACT
Procedures
shall
be
established
by
the
laboratory
for
the
review
of
requests,
tenders,
or
contracts.
The
policies
and
procedures
shall
ensure
that:

a.
the
requirements
including
the
methods
to
be
used
are
adequately
defined,
documented,
and
understood;

b.
the
laboratory
has
the
capability
and
resources
to
meet
the
requirements;

c.
the
appropriate
test
method
is
selected
and
capable
of
meeting
the
customer's
requirements.

Differences
between
the
customer's
request
and
the
contract
offered
to
the
customer
shall
be
resolved
before
any
work
commences.
The
contract
shall
be
acceptable
to
both
the
laboratory
and
customer.
Changes
made
at
the
contract
review
shall
be
recorded
and
maintained.
Contract
review
shall
also
cover
work
to
be
subcontracted
by
the
laboratory.
If
the
contract
requires
amendment
after
work
has
begun,
the
same
contract
review
process
shall
be
repeated
and
amendments
communicated
to
all
necessary
personnel.
The
customer
shall
be
informed
of
any
deviations
from
the
contract.

4.5
SUBCONTRACTING
OF
TESTS
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An
NLLAP
recognized
laboratory
shall
only
subcontract
work
when
necessary
and
with
approval
from
the
customer
with
another
NLLAP
recognized
laboratory.
The
laboratory
shall
be
able
to
demonstrate
that
the
subcontractor
is
accredited
by
an
NLLAP
recognized
accrediting
body
for
the
methods
in
question.
A
list
of
all
subcontractors
used
for
tests
shall
be
compiled
along
with
records
of
the
evaluation
of
the
subcontractors'
qualifications.

4.6
PURCHASING
SERVICES
AND
SUPPLIES
The
laboratory
shall
implement
policies
and
procedures
for
the
selection
and
purchase
of
services
and
supplies
that
impact
the
quality
of
tests.
Only
services
and
supplies
that
satisfy
and
maintain
the
quality
needed
to
produce
acceptable
test
results
shall
be
purchased.
The
laboratory
shall
have
procedures
for
the
purchase,
receipt
and
storage
of
reagents
and
laboratory
consumables
that
impact
the
quality
of
tests.

Purchasing
documents
shall
clearly
describe
the
product
ordered.
The
laboratory
shall
ensure
that
supplies
purchased
are
not
used
until
properly
inspected
or
otherwise
verified
for
compliance
with
standard
specifications
or
method
requirements.

4.6.1
Reagents
and
Standards
Requirements
for
reagents
and
standards
shall
be
specified
in
the
documented
MSM
and/
or
technical
procedures.

4.6.1.1
Reagent
Grades
Used
Reagents
shall
be
at
least
American
Chemical
Society
(
ACS)
reagent
grade
or
of
the
quality
specified
by
the
analytical
methods
in
use
by
the
laboratory.

4.6.1.2
Reagents
and
Standards
Tracking
Upon
receipt,
purchased
reagents
and
standards
shall
be
inspected,
dated
and
initialed
or
otherwise
evaluated
to
verify
the
purchasing
document
specifications
have
been
met.
An
expiration
date
shall
be
assigned
to
each
reagent.
Reagents
shall
not
be
used
beyond
assigned
expiration
dates
nor
used
if
damaged
or
contaminated
or
suspected
to
be
damaged
or
contaminated.

When
available,
the
laboratory
shall
maintain
certificates
of
analysis
or
other
documentation
on
the
manufacturer's
statement
of
purity,
of
the
origin
and
traceability
of
all
reagents
and
standards.

4.7
SERVICE
TO
THE
CUSTOMER
NLLAP
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DRAFT
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The
NLLAP
recognized
laboratory
shall
cooperate
with
the
customer.
This
may
include
providing
the
customer
or
customer
representative
reasonable
access
to
areas
of
the
laboratory
to
witness
work
performed
for
that
customer
or
providing
test
or
sample
items
needed
by
that
customer
for
purposes
of
verification.
The
laboratory
should
also
maintain
contact
with
the
customer
throughout
the
period
of
work
and
inform
the
customer
of
any
delays
and/
or
deviations
in
performance
of
the
tests.
Laboratories
are
also
encouraged
to
seek
feedback
from
the
customer
for
improvement
of
the
quality
system.

4.8
COMPLAINTS
The
laboratory
shall
have
a
documented
policy
and
procedures
for
the
resolution
of
complaints
received
from
customers
or
other
parties
about
the
laboratory's
activities
or
results.
The
policy
shall
include
the
notice
that
"
Any
complaint
about
the
quality
of
reported
results
may
be
referred
to
the
accrediting
authority
if
such
complaints
cannot
be
resolved
directly
with
the
customer."
A
record
shall
be
maintained
of
all
complaints
and
of
the
actions
taken
by
the
laboratory.
Where
a
complaint,
or
any
other
circumstance,
raises
doubt
concerning
the
laboratory's
compliance
with
policies
its
own
procedures,
the
requirements
of
this
document,
the
management
system
and/
or
the
quality
of
the
laboratory's
analyses,
the
laboratory
shall
ensure
that
those
areas
of
activity
are
promptly
audited.

4.9
IMPROVEMENTS
The
laboratory
shall
continually
improve
the
effectiveness
of
its
management
system
through
the
use
of
its
quality
policy,
quality
objectives,
audit
results,
analysis
of
data,
corrective
and
preventive
actions
and
management
review.

4.10
CONTROL
OF
NONCONFORMING
TESTS
The
laboratory
shall
have
a
documented
policy
and
procedures
for
handling
nonconforming
tests
and
for
describing
and
recording
actions
taken
when
nonconforming
tests
are
identified.
No
data
shall
be
reported
until
the
cause
of
the
problem
is
determined
and
corrected,
or
the
laboratory
demonstrates
that
the
root
cause
of
the
nonconformance
was
a
random
event.
The
laboratory
shall
maintain
records
of
all
nonconforming
tests
or
out­
of­
control
events,
the
determined
cause(
s),
and
corrective
action(
s)
taken.
Laboratory
shall
respond
to
customer
complaints
and
maintain
records
of
corrective
action.
Once
corrective
action(
s)
have
been
implemented,
the
laboratory
shall
monitor
the
results
to
make
sure
the
actions
taken
have
been
effective
at
addressing
the
problem(
s)
of
nonconformance.

4.11
CORRECTIVE
ACTION
NLLAP
LQSR
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DRAFT
16
4.11.1
General
A
policy
and
procedure
for
corrective
action
shall
be
established
and
implemented
for
use
by
appropriate
laboratory
authorities
when
nonconforming
work
is
identified.
Required
changes
to
the
operational
procedures
resulting
from
corrective
action
investigations
shall
be
properly
documented
and
implemented.
When
reported
results
have
been
affected
by
nonconforming
tests
all
affected
customers
shall
be
contacted
and
informed
of
the
corrective
action
taken
and
the
amended
results
(
see
5.10.4).

4.11.2
Cause
Analysis
Corrective
action
procedures
shall
begin
with
an
investigation
to
determine
the
root
cause(
s)
of
the
problem.

4.11.3
Corrective
Actions
Once
the
root
causes
have
been
identified,
the
laboratory
shall
identify
possible
corrective
actions.
The
action(
s)
most
likely
to
eliminate
the
problem
and
prevent
its
recurrence
shall
be
selected
and
implemented.

4.11.4
Monitoring
the
Corrective
Actions
Once
corrective
action(
s)
have
been
implemented,
the
laboratory
shall
monitor
the
results
to
make
sure
the
actions
taken
have
been
effective
at
addressing
the
problem(
s)
that
caused
the
nonconformance.

4.11.5
Special
Audits
If
there
is
doubt
that
the
laboratory
is
complying
with
its
own
policies
and
procedures
or
those
of
relevant
standards,
then
the
laboratory
shall
ensure
that
the
appropriate
areas
of
activity
are
audited.

4.12
PREVENTIVE
ACTION
Needed
improvements
and
potential
sources
of
nonconformance,
either
technical
or
concerning
the
management
system,
shall
be
identified.
When
improvement
opportunities
are
identified
or
if
preventive
action
is
required,
action
plans
shall
be
developed,
implemented
and
monitored
to
reduce
the
likelihood
of
the
occurrence
of
such,
nonconformities
and
to
take
advantage
of
the
opportunities
for
improvement.

4.13
RECORDS
NLLAP
LQSR
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17
The
records
for
each
laboratory
activity
shall
contain
sufficient
information
so
that
it
may
be
repeated
or
otherwise
verified.
The
record
keeping
system
shall
allow
historical
reconstruction
of
all
laboratory
activities
that
were
used
to
produce
the
associated
test
report.
The
record
keeping
system
shall
facilitate
the
retrieval
of
all
records.
Additional
record
keeping
guidance
available
from
ASTM:
E
2239
"
Standard
Practice
for
Record
Keeping
and
Record
Preservation
for
Lead
Hazard
Activities".

a.
All
records
(
including
those
pertaining
to
calibration
and
test
equipment,
certificates,
and
reports)
shall
be
safely
stored,
held
secure
and
in
confidence
to
the
customer.

b.
All
records
of
the
laboratory
associated
with
its
work
activities
shall
be
retained
for
a
minimum
of
three
years.
All
hardware
and
software
necessary
for
the
historical
reconstruction
of
data
must
be
maintained
by
the
laboratory.
These
records
shall
include
a
history
of
the
locations
of
mobile
laboratory
and
FSMO
operations,
including
a
specific
description
of
where
the
sampling
and
testing
work
activity
was
performed
and
these
records
shall
be
maintained
for
at
least
three
years.

c.
Access
to
archived
records
shall
be
controlled
and
shall
be
protected
against
fire,
theft,
loss,
environmental
deterioration,
vermin,
and
in
the
case
of
electronic
records,
electronic
or
magnetic
sources.

d.
In
the
event
that
a
laboratory
goes
out
of
business,
the
laboratory
shall
have
a
plan
to
ensure
that
its
records
are
maintained
or
transferred
according
to
the
customer's
instructions
and
applicable
regulations.

e.
The
records
shall
include
the
identity
of
all
personnel
involved
in
sampling
(
if
known),
sample
preparation,
calibration,
analysis,
final
reporting
and
a
signature
and
initial
record
for
the
involved
employees
shall
be
created
and
maintained.

f.
Entries
in
records
shall
not
be
obliterated
by
methods
such
as
erasures,
overwritten
files,
or
markings.
All
corrections
and/
or
amendments
to
records
shall
be
made
with
a
single
strike
out
line
through
the
error
and/
or
the
correct
data
or
value
added
alongside,
as
appropriate.
All
handwritten
data
shall
be
recorded
using
indelible
ink.
The
individual
making
the
correction
shall
sign
(
or
initial)
and
date
the
correction.

4.13.1
Sample
Records
NLLAP
LQSR
Rev.
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05
DRAFT
18
A
record
of
all
procedures
to
which
sample
is
subjected
(
sampling,
preparation
and
testing)
while
in
the
possession
of
the
laboratory
shall
be
maintained
for
aperiod
of
at
least
3
years
as
a
readily
retrievable
hard
copy
or
electronic
media
that
can
be
generated
without
change.
These
records
shall
include,
but
are
not
limited
to,
records
of
a.
Sample
identification,
receipt,
acceptance
or
rejection
and
log­
in;

b.
Sample
storage
and
tracking
including
shipping
receipts;

c.
Sample
preparation,
instrument
printouts,
and
calculations;

d.
Sample
analysis
logs;

e.
Standard
and
reagent
origin,
receipt,
preparation,
and
use;

f.
Equipment
and
instrument
operating
conditions;

g.
Calibration
criteria,
frequency
and
acceptance
criteria;

h.
Data
and
statistical
calculations,
review,
confirmation,
interpretation,
assessment,
and
reporting
conventions;

i.
Method
performance
criteria;

j.
Quality
control
protocols
and
assessment;

k.
Storage
and
retention;
and
l.
Sample
disposal
procedures
and
schedule.

4.13.2
Laboratory
Management
System
and
Test
Records
In
addition
to
documenting
all
the
above
mentioned
activities,
the
following
shall
be
retained:

a.
All
original
raw
data,
whether
hard
copy
or
electronic,
for
sampling
and
testing
activities
to
include:
calibrations,
samples,
and
quality
control
measurements,
work
sheets
and
data
output/
instrument
response
readout
records;

b.
A
written
description
or
reference
to
the
specific
method
used
which
includes
a
description
of
the
specific
steps
in
the
calculation
used
to
translate
parametric
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Rev.
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DRAFT
19
observations
into
a
reportable
analytical
value;

c.
Copies
of
final
reports;

d.
Archived
standard
operating
procedures;

e.
Correspondence
relating
to
laboratory
work
activities;

f.
All
corrective
action
reports,
audits,
and
audit
responses;

g.
Performance
evaluation
results
and
raw
data;
and
h.
Data
review
and
cross
checking.

4.13.3
Electronic
Data
Where
computers
or
automated
equipment
are
used
for
the
capture,
processing,
manipulation,
recording,
reporting,
storage
or
retrieval
of
data,
the
laboratory
shall
ensure
that:

a.
Electronic
computer
records
can
satisfy
the
record
keeping
requirement
without
hard
copy
files
if
hard
copies
can
be
generated
without
changing
the
information.

b.
The
computer
programs
are
validated
before
they
are
used
and
whenever
the
programs
are
changed.

c.
Computer
file
back
up
procedures
are
completed
in
accordance
with
a
predetermined
schedule.

d.
Records
that
are
stored
or
generated
by
computers,
have
a
hard
copy
or
writeprotected
backup
copies.

4.14
INTERNAL
AUDITS
At
least
annually,
the
laboratory
shall,
in
accordance
with
a
predetermined
schedule
and
procedure,
conduct
internal
audits
of
its
activities
to
ensure
that
operations
comply
with
the
requirements
of
this
document
and
the
established
management
system.
The
quality
manager
shall
be
responsible
for
the
planning
and
implementation
of
such
audits.
Such
audits
shall
be
carried
out
by
trained
and
qualified
staff
who
are,
whenever
possible,
independent
of
the
activities
to
be
audited.
All
relevant
information
pertaining
to
the
audit
activity
shall
be
recorded.
In
a
one­
person
organization,
the
annual
audits
may
be
conducted
by
the
one
member
of
the
laboratory
if
that
person
follows
independent
third­
party
guidance
for
conducting
a
quality
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system
audit,
such
as
ISO
19011,
Guidelines
for
quality
and/
or
environmental
management
systems
auditing
or
similar
third
party
guidance
published
by
organizations
such
as
ASTM
(
American
Society
for
Testing
and
Materials)
or
ANSI
(
American
National
Standards
Institute)
and
creates
and
maintains
a
written
audit
report
of
the
audit
findings
in
its
record
system.
Alternatively,
the
one­
person
organization
may
choose
to
contract
out
the
internal
audit
to
an
independent
person
or
firm
that
is
competent
and
has
the
experience
and
training
to
conduct
an
audit
of
a
quality
system.

When
the
audit
finds
doubt
on
the
correctness
or
validity
of
the
laboratory
test
results,
timely
corrective
action
shall
be
taken
by
the
laboratory.
If
the
audit
indicates
that
laboratory
results
may
have
been
affected,
customers
shall
be
notified
and
informed
of
the
corrective
action
taken
and
the
amended
results.

4.15
MANAGEMENT
REVIEWS
The
quality
system
adopted
to
satisfy
the
requirements
of
the
NLLAP
LQSR
shall
be
reviewed
at
least
once
a
year
by
the
laboratory
management
to
ensure
its
continuing
suitability
and
effectiveness
and
to
introduce
any
necessary
changes
or
improvements
(
see
Section
4.9).
Such
reviews
shall
be
carried
out
by
the
laboratory
management
in
accordance
with
a
predetermined
schedule
and
procedure.
The
review
shall
take
account
of:

#
the
suitability
of
policies
and
procedures;

#
reports
from
managerial
and
supervisory
personnel;

#
the
outcome
of
recent
internal
audits;

#
corrective
and
preventive
actions;

#
assessments
by
external
bodies;

#
the
results
of
interlaboratory
comparisons
or
proficiency
tests;

#
changes
in
the
volume
and
type
of
the
work;

#
customer
feedback;

#
complaints;

#
recommendations
for
improvement
#
other
relevant
factors,
such
as
quality
control
activities,
resources
and
staff
training.

All
relevant
information
pertaining
to
the
management
review
shall
be
recorded.
The
laboratory
management
shall
ensure
that
necessary
changes
or
improvements
are
carried
out
within
an
appropriate
and
agreed
timescale.

5.0
TECHNICAL
REQUIREMENTS
5.1
GENERAL
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21
Many
factors
contribute
to
the
correctness
and
reliability
of
lead
measurements
performed
by
a
laboratory.
These
factors
include
contributions
from:

#
human
factors
(
5.2)

#
accommodation
and
environmental
conditions
(
5.3)

#
test
and
calibration
methods
and
method
validation
(
5.4)

#
equipment
(
5.5)

#
measurement
traceability
(
5.6)

#
sampling
(
5.7)

#
sample
handling
(
5.8)

These
factors
shall
be
taken
into
account
by
the
laboratory
in
developing
test
and
calibration
methods,
in
training
personnel,
and
in
the
selection
of
equipment
used.

5.2
PERSONNEL
Laboratory
management
shall
ensure
that
all
laboratory
personnel
performing
NLLAP
recognized
analyses
are
educated,
trained,
experienced,
skilled
and
competent
in
performing
lead
sampling
and
testing
activities,
as
appropriate.
Staff
assigned
to
operate
equipment,
perform
tests,
evaluate
results,
and
sign
test
reports
shall
be
qualified
and
authorized
in
writing
by
management
to
do
so.
When
using
staff
in
training,
adequate
supervision
shall
be
provided.
A
record
of
all
employees
and
their
associated
competence,
training,
skills,
experience,
authorizations
and
professional
qualifications
shall
be
clearly
defined,
documented,
and
maintained
on
file.
The
criteria
and
training
requirements
for
laboratory
personnel
shall
be
clearly
defined,
documented,
and
readily
available.
Training
records
shall
include
a
description
of
training
program
contents,
the
duration
of
the
training,
qualifications
of
the
trainer,
and
evidence
that
the
analyst/
technician
has
successfully
demonstrated
their
competence,
such
as
described
in
Section
5.2.1.1.

Goals
for
the
laboratory
training
program
shall
be
formulated
by
laboratory
management
and
a
training
program
shall
be
in
place
to
address
the
training
needs
of
laboratory
employees
and
shall
be
relevant
to
the
present
and
anticipated
needs
of
the
laboratory.
The
effectiveness
of
the
training
shall
be
evaluated.
The
laboratory
shall
maintain
current
job
descriptions
for
managerial,
technical,
and
key
support
staff
involved
in
sampling
and
testing
activities,
as
appropriate.

The
NLLAP
recognized
laboratory
shall
use
permanently
employed
staff
or
those
under
contract
to
the
laboratory.
When
additional
support
or
technical
personnel
are
needed,
the
laboratory
shall
ensure
that
such
personnel
are
competent,
supervised
and
work
within
the
management
system.
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DRAFT
22
5.2.1
Analysts/
Technicians
Personnel
who
function
as
analysts
and/
or
technicians
(
however
named)
in
the
laboratory
shall
have
the
education,
training,
experience
and/
or
demonstrated
skills
or
combination
thereof,
to
enable
them
to
adhere
to
the
implemented
quality
system
and
to
competently
perform
test
procedures,
operate
laboratory
equipment,
evaluate
test
results
and
sign
test
reports
(
when
authorized).

5.2.1.1
Minimum
Qualifications
and
Training
for
Analyst/
Technician
Personnel
5.2.1.1.1
NLLAP
analysts
and/
or
technicians
shall
have
hands
on
experience
conducting
lead
sampling
and
testing
activities,
as
appropriate,
before
being
authorized
to
work
on
NLLAP
related
samples.

5.2.1.1.2
Analysts
and
technicians
shall
complete
an
external
and/
or
internal
training
program
for
lead
sampling
and
testing
activities,
as
appropriate,
prior
to
performing
those
activities
on
NLLAP
related
samples.
Courses
on
sample
selection,
collection,
preparation
(
when
applicable)
and
instrumental
analysis
may
be
taken
separately
or
combined.
The
criteria
and
training
requirements
for
laboratory
personnel
shall
be
clearly
defined,
documented
and
maintained
on
file.
A
description
of
the
training
program
content,
the
duration
of
the
training,
qualifications
of
the
trainer,
and
objective
evidence
that
the
analyst
/
technician
has
successfully
selected
and/
or
collected
samples
and
prepared
and
tested,
as
appropriate,
unknown
reference
samples
of
the
matrices
of
concern
within
the
specified
acceptance
criteria
must
be
maintained
by
the
laboratory.

5.2.1.1.3
The
analyst/
technician
trainee
shall
complete
a
minimum
of
four
independent
test
runs
of
sample
preparation
(
when
applicable)
and/
or
instrumental
analysis
for
each
matrix.
An
independent
run
is
defined
as
analysis
of
at
least
five
samples
of
known
lead
content,
one
of
which
is
a
certified
reference
material
or
proficiency
testing
material
and
is
separated
by
a
period
of
time
sufficient
to
evaluate
the
performance
of
any
previous
independent
run.
For
sample
preparation
training,
the
recoveries
of
the
associated
reference
materials
or
proficiency
training
samples
for
each
run
must
be
within
+
20%
of
the
certified
value,
75%
of
the
time.
For
instrumental
analysis
training,
the
recoveries
of
the
associated
reference
materials
or
proficiency
training
samples
for
each
run
must
be
within
+
20%
of
the
certified
value,
75%
of
the
time.

For
some
analytical
testing
technologies
it
may
not
be
possible
to
separate
the
sample
preparation
techniques
from
instrumental
analyses.
In
such
cases,
the
NLLAP
LQSR
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05
DRAFT
23
training
requirements
shall
be
based
upon
the
minimum
requirements
stated
for
both
analysts
and
technicians.

The
reference
material/
proficiency
test
samples
utilized
shall:
1)
be
similar
to
matrices
the
analyst
/
technician
will
encounter
during
routine
lead
sample
analysis,
and
2)
cover
the
sample
mass/
concentration
range
for
which
the
analytical
SOP
has
been
validated.

5.2.1.1.4
Analyst/
technicians
authorized
to
perform
lead
testing
shall
periodically
demonstrate
their
ability
to
proficiently
test
samples
for
lead
by
analyzing
standard
reference
materials
(
SRMs),
certified
reference
materials,
proficiency
testing
materials
or
other
quality
control
samples
during
routine
sample
analysis.
This
demonstration
shall
be
evaluated
at
least
every
six
months.

5.2.1.2
Additional
Requirements
for
Mobile
and
FSMO
Personnel
5.2.1.2.1
All
mobile
laboratory
and
FSMO
personnel
involved
in
the
selection
of
samples
or
sampling
areas
as
a
part
of
a
lead­
based
paint
risk
assessment
in
target
housing
and/
or
child
occupied
facilities
shall
also
be
certified
by
EPA
or
an
authorized
state
or
tribal
program
as
a
risk
assessor/
inspector/
sampling
technician
as
pursuant
to
Section
402
of
the
Toxic
Substance
Control
Act
(
TSCA)
and
its
implementing
regulations.

5.2.1.2.2
All
mobile
or
FSMO
technicians
shall
be
evaluated
by
a
competent
supervisor
for
their
first
two
NLLAP­
related
job
sites.

5.3
ACCOMMODATION
AND
ENVIRONMENTAL
CONDITIONS
Any
fixed
site
or
mobile
laboratory
operation
shall
have,
as
appropriate,
the
space,
equipment,
instruments,
ventilation,
utility
services,
storage
space,
safety
equipment,
and
documentation
and
references
necessary
to
accomplish
the
analyses
for
lead
concentrations
in
the
matrices
of
concern
(
see
29
CFR
§
1910.1450
for
information).
FSMOs
shall
have
appropriate
storage
facilities
to
maintain
the
integrity
of
the
testing
equipment
when
not
in
use.

Temperature,
humidity,
ventilation,
dust,
and
vibration
shall
be
controlled
and/
or
monitored
to
meet
instrument
and/
or
sample
analysis
requirements.
Tests
shall
be
terminated
when
environmental
conditions
jeopardize
the
results
of
the
test.

Incompatible
activities
in
the
laboratory
shall
be
separated
to
prevent
crosscontamination
Access
to
areas
affecting
the
quality
of
test
and/
or
calibrations
shall
be
controlled.
The
integrity
of
the
laboratory
shall
be
maintained
with
good
housekeeping
NLLAP
LQSR
Rev.
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05
DRAFT
24
practices.
For
laboratories
operating
portable
testing
technologies,
sample
collection
and
field
testing
shall
be
conducted
so
as
to
minimize
the
chance
of
cross­
contamination.
Site
access
shall
be
controlled
to
the
extent
possible
while
sampling
and
testing
are
taking
place.
Activities
at
the
site
shall
be
conducted
to
minimize
the
possibility
of
creating
a
hazard
during
or
after
testing,
or
contaminating
the
site
from
sampling
and
testing.

5.3.1
Contamination
Control
5.3.1.1
Laboratory
Dust
Wipe
Checks
For
fixed­
site
and
mobile
laboratory
facilities,
wipe
sampling
of
sample
preparation
and
testing
area
surfaces
shall
be
conducted
at
least
quarterly
to
determine
surface
concentration
levels
of
lead.
Sample
preparation
and
analysis
is
not
to
proceed
until
surface
contamination
is
below
the
specified
maximum
allowable
concentration
of
50
percent
of
the
lowest
regulatory
limit
for
dust
wipe
samples.
For
FSMO,
appropriate
contamination
control
blank
samples
shall
be
run
in
order
to
monitor
potential
lead
contamination.

5.3.1.2
Labware
Cleaning
Cleaning
procedures
for
labware
shall
be
specified
by
the
laboratory
in
a
written
SOP.
The
procedure
shall
include,
where
applicable,
a
specified
frequency
for
monitoring
of
lead
concentrations
in
cleaning
baths,
the
monitoring
of
glassware
contamination
during
the
analysis
of
reagent
or
other
blanks,
and
periodic
monitoring
of
disposable
labware
contamination
by
analyzing
of
reagent
or
other
blanks.

5.4
TEST
AND
SAMPLING
METHODS
5.4.1.
Acceptable
Methodology
The
test
methods
or
written
SOPs,
dated
and
approved
by
the
appropriate
authority,
shall
be
available
for
use
where
work
activities
are
performed.
The
laboratory
shall
have
demonstrated
that
the
test
and/
or
sampling
methods
used
are
suited
for
the
intended
use.
In
addition
the
laboratory
shall
have
records
of
method
performance
demonstration
and
validation
for
laboratory
developed
or
modified
procedures.
This
includes
MDL,
Bias
and
Precision.

a.
Methods
shall
not
be
used
for
sample
analysis
until
the
laboratory
has
confirmed
and
documented
their
proficiency.
Competency
shall
be
demonstrated
over
the
lead
concentration
and
sample
mass
ranges
for
each
matrix
stated
by
the
method,
as
appropriate.

b.
Where
sample
preparation
and
analysis
methods
are
not
specified
by
regulatory
NLLAP
LQSR
Rev.
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05
DRAFT
25
programs,
the
laboratory
shall,
whenever
possible,
use
validated
procedures
published
by
federal
agencies
such
as
EPA,
HUD
or
NIOSH,
state
agencies,
or
nationally
or
internationally
recognized
consensus
standards
organizations
such
as
ASTM
International.
For
methods
under
consideration
for
analytical
testing
the
laboratory
shall
demonstrate
it
can
achieve
a
quantitation
limit
equal
to
or
less
than
20
percent
of
the
lowest
relevant
action
level
or
regulatory
limit
of
interest
for
paint
and
soil
and
50
percent
of
the
lowest
action
level
for
dust
wipe
samples.
Laboratory
SOPs
for
sample
analysis
may
require
additional
QC
procedures
to
those
stated
in
the
published
methods
in
order
to
meet
requirements
of
this
document.

Acceptable
sampling
methods
are
cited:
40
CFR
Part
745
­
Lead­
Based
Paint
Activities.

c.
New,
alternative
or
modified
analytical
methods
and/
or
new
testing
technologies
may
be
used
by
a
laboratory
if
they
have
been
validated
by
the
laboratory
or
a
third
party,
and
shown
to
meet
the
minimum
performance
requirements
stated
in
5.4.1(
b).
The
method
validation
must
be
documented
by
the
laboratory
or
qualified
third
party.
In
the
case
where
validation
is
done
by
a
party
other
than
the
laboratory,
the
laboratory
shall
confirm
its
competency
utilizing
the
method
as
described
above
in
Section
5.4.1(
a).

Acceptable
operating
characteristics
for
non­
numerical
or
pass­
fail
technologies
(
positive
or
negative
screen
technologies)
shall
be
appropriate
to
the
associated
regulatory
limits
(
e.
g.,
the
measured
value
including
its
95%
uncertainty
of
measurement
must
be
less
than
the
associated
regulatory
limit).

d.
When
a
laboratory
offers
analyses
of
composite
dust
wipe
samples,
the
laboratory
analytical
method
for
composite
dust
wipe
samples
shall
address
increase
of
sample
mass.
Laboratory
shall
meet
the
minimum
performance
requirements
stated
in
5.4.1(
b)
and
demonstrate
its
competency
utilizing
the
method
as
described
above
in
Section
5.4.1(
a).

5.4.2
Method
Validation
and
Performance
Demonstration
Procedures
A
list
of
guidance
documents
that
should
be
helpful
in
dealing
with
method
validation
and
performance
demonstration
that
include
good
professional
laboratory
principles
and
practices
are
listed
below:

#
AOAC
International
operates
method
validation
programs.
Information
on
these
programs
is
available
at:
http://
www.
aoac.
org/
vmeth/
page1.
htm
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
26
#
U.
S.
EPA
Office
of
Solid
Waste
"
Guidance
for
Method
Development
and
Method
Validation
for
the
RCRA
Program,
June
1995."
at:
www.
epa.
gov/
SW­
846/
methdev.
htm
#
"
Guidelines
for
Collaborative
Study
Procedure
to
Validate
Characteristics
of
a
Method
of
Analysis,"
J.
Assoc.
Off.
Chem.,
Vol.
72,
No.
4,
1989,
p.
694
#
"
Meeting
the
Traceability
requirements
of
ISO
17025­
An
Analyst's
Guide,"
2nd
Edition,
at:
www.
vam.
org.
uk/

#
"
Preparation
of
Calibration
Curves­
A
Guide
to
Best
Practice,"
September
2003,
LGC/
VAM/
2003/
032,
at:
www.
vam.
org.
uk/

#
"
New
Eurachem/
CITAC
guidance
on
traceability
of
chemical
measurements:
A
paradigm
for
practical
traceability,"
April
2003,
LGC/
VAM/
2003/
016,
at:
www.
vam.
org.
uk/

#
"
Quantifying
Uncertainty
in
Analytical
Measurement,
2nd
Edition,"
QUAM2000­
1,
2000,
at:
www.
vam.
org.
uk/

#
"
EURACHEM/
CITAC
Guide:
Traceability
in
Chemical
Measurement­
A
Guide
to
Achieving
Comparable
Chemical
Measurement,"
2003,
at:
www.
vam.
org.
uk/

#
"
In­
house
method
validation:
A
guide
for
chemical
laboratories,"
2003,
at:
www.
vam.
org.
uk/

#
"
A
Practical
Guide
to
Analytical
Method
Validation",
Analytical
Chemistry
1996,
(
68)
305A­
309A,
published
at:
http://
pubs.
acs.
org/
hotartcl/
ac/
96/
may/
may.
html
#
"
The
Fitness
for
Purpose
of
Analytical
Methods­
A
laboratory
Guide
to
Method
Validation
and
Related
Topics,"
EURACHEM
Guide
1998,
at:
www.
eurachem.
ul.
pt/

#
"
Standard
Practice
for
Determining
the
Precision
of
ASTM
Methods
for
Analysis
and
Testing
of
Industrial
and
Specialty
Chemicals"
ASTM
International
Practice
Designation
E
180,
at:
www.
astm.
org
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
27
#
"
Standard
Practice
for
Conducting
an
Interlaboratory
Study
to
Determine
the
Precision
of
a
Test
Method,"
ASTM
International
Practice
Designation
E
691,
at:
www.
astm.
org
#
"
Standard
Guide
for
Demonstrating
and
Assessing
Whether
a
Chemical
Analytical
Measurement
system
Provides
Analytical
Results
Consistent
with
Their
Intended
Use,"
ASTM
International
Guide
Designation
D
6956­
03,
at:
www.
astm.
org
#
"
Standard
Guide
for
Conducting
Ruggedness
Tests,"
ASTM
International
Guide
Designation
E
1169,
at:
www.
astm.
org
#
"
Standard
Guide
for
Evaluating
Laboratory
Measurement
Practices
and
the
Statistical
Analysis
of
the
Resulting
Data"
ASTM
International
Guide
Designation
E
1323,
at:
www.
astm.
org
#
"
Standard
Guide
for
Statistical
Procedures
to
Use
in
Developing
and
Applying
Test
Methods,"
ASTM
International
Guide
Designation
E
1488,
at:
www.
astm.
org
5.4.3
Sample
Preparation
and
Analysis
Procedures
5.4.3.1
Standard
Operating
Procedures
All
method
SOPs
shall
be
available
to
all
personnel
at
the
locations
where
work
activities
are
performed
and
shall
include
information
addressing
the
following
areas,
as
appropriate:

#
method
detection
limit
#
scope
and
application
#
summary
of
the
method
#
definitions
#
applicable
matrix
or
matrices
#
applicable
lead
concentration
range
#
applicable
sample
mass
range
#
method
performance
(
accuracy
and
precision)

#
interferences
#
safety
considerations
#
reagents
and
standards
#
equipment
and
supplies
#
sample
collection
(
where
applicable)

#
sample
preservation
and
storage
(
where
applicable)
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
28
#
sample
preparation
including
grinding,
homogenization,
and
subsampling
(
where
applicable)

#
instrument
calibration/
verification
#
quality
control
procedures
#
detailed
step­
by­
step
procedures
#
calculations
#
data
acceptance
criteria
#
corrective
actions
for
out­
of­
control
data
#
contingencies
for
handling
out
of
control
data
#
references
Laboratory
SOPs
which
do
not
address
all
of
the
areas
stated
above
shall
be
amended
in
accordance
with
the
laboratory's
SOP
on
document
control,
revision
/
change,
which
may
permit
the
use
of
attachments
in
order
to
meet
this
requirement
or
reference
other
quality
system
documents
as
appropriate.
All
operating
procedures
relevant
to
the
work
being
conducted
shall
be
available
for
use
where
the
work
activities
are
performed.

5.4.4
Method
Performance
Characteristics
The
acceptable
minimum
method
performance
characteristics
provided
in
Tables
3
and
4
of
this
document
shall
be
replaced
by
the
laboratory's
own
statistically
determined
performance
characteristics
and
shall
not
be
greater
than
values
stated
in
Tables
3
and
4.

5.4.4.1
Method
Detection
Limits
Method
detection
limits
(
MDLs)
shall
be
established,
statistically
verified
and
monitored,
as
needed
for
each
method
and
matrix
of
concern.
For
methods
with
stated
MDLs,
demonstration
of
ability
to
achieve
such
MDLs
is
required
and
shall
be
documented.
MDLs
shall
be
determined
using
a
documented
SOP
that
is
based
on
procedures
published
or
recognized
by
nationally
or
internationally
acknowledged
technical
authorities.

5.4.4.2
Quantitation
and
Reporting
Limits
The
quantitation
limit
shall
be
"
less
than"
("<")
a
value
at
least
2
times
but
no
greater
than
10
times
the
method
detection
limit
as
determined
in
Section
5.4.4.1.

5.4.4.3
Accuracy
and
Precision
Accuracy
and
precision
shall
be
determined
for
each
analytical
method.
The
method
evaluation
results
shall
be
documented
and
kept
on
file.
Acceptable
minimum
method
performance
criteria
for
accuracy
and
precision
can
be
found
in
Tables
3
and
4
of
this
document.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
29
5.4.5
Sample
Aliquots
Where
subsampling
(
obtaining
sample
aliquots
from
a
submitted
sample)
is
carried
out
as
part
of
the
analytical
method,
the
laboratory
shall
use
documented
procedures
and
appropriate
techniques
to
obtain
representative
subsamples.

5.4.6
DATA
REDUCTION
AND
REVIEW
PROCESS
The
data
reduction
and
review
process
shall
be
conducted
by
a
qualified
person
and
include,
but
not
necessarily
be
limited
to:
comparison
of
quality
control
data
against
established
acceptance
limits,
computation
verification,
transcription
of
data,
and
adherence
to
the
procedures
established
in
the
laboratory
SOPs.
Where
appropriate,
computations
shall
be
verified
and
transcription
of
data
double
checked.
Qualified
persons
can
be
technicians,
analysts,
the
quality
manager,
or
technical
manager,
or
the
responsible
person
described
previously
in
Section
4.0.

In
the
case
of
a
one
person
laboratory,
or
where
a
qualified
person
is
not
available
for
the
review,
the
following
options
may
be
followed
to
complete
the
review.

Option
1.
The
review
process
may
be
conducted
using
an
SOP
that
is
part
of
the
laboratory's
management
system.

Option
2.
The
review
process
may
be
contracted
out
if
the
SOP
above
is
followed.

Option
3.
The
one
person
or
available
person
follows
the
SOP
referred
to
above
and
double
checks
all
QC
samples
results
for
correctness
and
conformance
to
acceptance
levels,
double
checks
all
results
equal
to
or
above
applicable
action
levels
for
correctness,
and
double
checks
20%
of
the
remaining
sample
results
for
correctness,
using
a
random
number
generator
or
sample
selection
software
to
select
samples
independently.

The
review
process
shall
be
documented
and
signed
by
the
reviewer,
and
shall
be
retained
on
file
with
a
copy
of
the
final
report
for
a
minimum
of
three
years.

5.5
EQUIPMENT
The
laboratory
shall
be
furnished
with
the
proper
equipment
to
perform
the
necessary
tests.
Should
the
laboratory
need
to
use
equipment
outside
its
permanent
control,
it
shall
ensure
that
all
NLLAP
requirements
for
equipment
and
instrumentation
are
met.
All
equipment
used
for
sample
preparation
or
for
instrumental
analysis
shall
be
maintained
and
calibrated
in
accordance
with
manufacturer
instructions,
as
well
as
any
specifications
stated
in
the
analytical
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
30
methods.
Standards
used
for
calibration
shall
be
traceable
to
National
Institute
of
Standards
and
Technology
(
NIST)
standards
(
when
available).
Equipment
is
to
be
used
by
authorized
personnel
only.

Each
item
of
equipment
shall
be
uniquely
identified
when
possible
and
records
shall
be
maintained
for
each
major
instrument,
including
records
of
in­
house
preventive
maintenance
and
service.
The
calibration/
verification
frequency
for
each
instrument
shall
be
established
and
documented.
The
documentation
shall
include
descriptions
of
the
problem
or
service,
dates
and
types
of
repair,
organization
and
person
performing
repair,
and
contact
phone
number
shall
be
recorded.
Instruments
that
are
found
to
be
out
of
calibration
or
defective
shall
be
taken
out
of
service
until
repaired
and
demonstrated
to
be
functioning
within
documented
acceptance
limits.
The
record
shall
identify
the
instrument
by
make,
model
number,
serial
number,
and
when
available,
the
date
placed
in
service.

To
prevent
contamination
or
deterioration,
the
laboratory
shall
have
procedures
for
the
safe
handling,
transport,
storage,
use,
and
maintenance
of
measurement
equipment.
Equipment
that
has
been
mishandled,
operates
outside
expected
limits,
or
provides
suspect
results
shall
be
removed
from
service
and
marked
accordingly
until
it
can
be
repaired,
recalibrated,
and
returned
to
service.
Likewise,
equipment
that
goes
outside
the
control
of
the
laboratory
for
any
period
of
time
must
be
checked
and
shown
to
provide
satisfactory
performance
before
being
returned
to
service.

All
equipment
used
to
collect,
prepare
and
test
samples
for
lead
shall
have
SOPs
for
their
calibration/
verification
and
maintenance
and
shall
be
readily
available
for
use
where
these
activities
are
performed.

5.5.1
Instrument
Calibration
and
Performance
Quality
Checks
Instruments
that
are
routinely
calibrated
shall
be
calibrated
daily
or
prior
to
analyzing
samples.
Acceptable
instrument
performance
shall
be
demonstrated
daily
or
prior
to
use.
Such
checks
may
include
evaluation
of
instrument
sensitivity,
noise
levels,
instrument
response
and
interference
levels
to
be
compared
to
historical
performance
values.
Acceptance
criteria
shall
be
determined,
documented
and
used.

All
instrument
calibration/
performance
verification
shall
be
performed
using
matrix
matched
reference
standard
materials
of
the
same
matrix
as
the
samples
being
measured,
when
available.
These
standard
materials
shall
be
traceable
to
NIST
standards
(
when
available).
In
the
absence
of
sufficient
data
for
statistical
determination
of
adequate
QC
limits
and
frequency,
the
types
of
QC
samples,
minimum
frequencies
and
the
required
minimum
acceptance
limits
shown
in
Tables
1
and
2
shall
be
met,
as
appropriate.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
31
5.5.2
Instrument
Calibration
Performance
Requirements
Instruments
and
equipment
used
for
testing
that
have
a
significant
effect
on
the
accuracy
of
the
result
shall
be
calibrated
prior
to
use.
The
laboratory
shall
have
an
established
system
for
equipment
calibration,
where
applicable.
See
"
Preparation
of
Calibration
Curves­
A
Guide
to
Best
Practice,"
September
2003,
LGC/
VAM/
2003/
032,
www.
vam.
org.
uk/
for
the
guidance.

a.
All
calibration
curves
shall
cover
(
bracket)
the
expected
sample
concentration
range
with
the
concentrations
of
the
calibration
standards
evenly
distributed
across
the
range.
The
calibration
curves
shall
be
dated,
labeled
and
include
at
least
the
following
information:
applicable
method,
instrument
identification,
analysis
date,
lead
concentrations,
instrument
response,
identify
the
personnel
responsible
for
the
calibration.

b.
When
used,
the
axis
of
the
calibration
curve
shall
be
labeled.
For
electronic
data
processing
systems
that
automatically
compute
the
calibration
curve,
the
equation
for
the
curve
and
the
correlation
coefficient
must
be
recorded.
The
equation
for
the
line
and
the
correlation
coefficient
shall
also
be
recorded
when
the
calibration
curve
is
prepared
manually.

c.
A
criterion
for
the
acceptance
of
a
calibration
curve,
(
for
example,
an
acceptable
correlation
coefficient)
shall
be
established
and
documented.

d.
All
initial
instrument
calibration
shall
be
verified
using
standards
obtained
from
a
different
source
than
initial
calibration
standards.

e.
The
sample
results
shall
be
bracketed
by
calibration
standards
under
all
circumstances.

5.5.2.1
Initial
Calibration
A
minimum
of
three
calibration
standards,
which
bracket
the
sample
concentrations,
and
an
initial
calibration
blank
(
ICB)
shall
be
analyzed
and
used
to
construct
a
calibration
curve
prior
to
the
analysis
of
samples,
as
appropriate.
Calibration
acceptance
criteria
shall
be
stated.
New
calibration
curves
shall
be
prepared
whenever
an
out
of
control
condition
is
indicated
and/
or
after
new
reagents
are
prepared.
For
those
technologies
and
software
packages
requiring
fewer
calibration
standards,
follow
the
manufacturer's
recommendations
(
e.
g.,
the
instrument
operations
manual).

When
linear
fit
is
used,
linearity
shall
be
evaluated
by
using
the
calibration
standards.
Acceptance
criteria
shall
be
stated
(
See
Tables
1
and
2).
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
32
5.5.2.2
Independent
Calibration
Verification
An
independent
calibration
verification
(
ICV)
standard
shall
be
analyzed
daily
or
prior
to
analyzing
samples.
See
Tables
1
and
2
for
minimum
performance
acceptance
criteria.

For
an
instrument
which
produces
a
numerical
result,
the
ICV
standard
shall
be
at
a
lead
concentration
in
the
range
of
customer
specified
lead
levels
of
concern
or
action
levels
such
as
regulatory
limits.

For
an
instrument
(
or
equivalent)
which
produces
a
pass­
fail
result,
the
ICV
positive
(
ICV­
P)
with
lead
level
no
more
than
20%
above
the
applicable
regulatory
limit
(
omit
for
positive
screen
technologies)
and/
or
negative
(
ICV­
N)
with
lead
level
no
less
than
20%
below
the
applicable
regulatory
limit
(
omit
for
negative
screen
technologies).

5.5.2.3
Continuing
Calibration
Verification
Continuing
calibration
verification
(
CCV)
standards
shall
be
analyzed
in
accordance
with
the
SOP.
The
CCV
standard
may
be
prepared
from
independent
reference
standards
or
from
the
same
standards
used
to
prepare
the
instrument
calibration
curve.
Acceptance
criteria
shall
be
stated
(
See
Tables
1
and
2
for
minimum
performance
acceptance
criteria).

a.
At
least
two
standards
shall
be
analyzed
every
12
hours,
or
according
to
instrument
manufacturer's
recommendations,
or
at
a
predetermined
SOP
frequency
whichever
is
most
frequent.

b.
For
an
instrument
which
produces
a
numerical
result,
the
concentration
of
these
standards
shall
be
determined
by
the
confirmed
operating
range
of
the
instrument,
regulatory
limits
and/
or
method
specified
levels.
At
least
one
standard
shall
be
at
or
below
the
laboratory
established
reporting
limit.
To
the
extent
possible,
the
samples
in
each
interval
should
be
bracketed
with
standard
concentrations
closely
representing
the
lower
and
upper
range
of
analyzed
concentrations
(
diluted,
if
necessary).
If
this
is
not
possible,
the
standard
calibration
checks
should
be
prepared
covering
the
expected
concentration
range
of
the
samples
being
tested.

c.
For
an
instrument
(
or
equivalent)
which
produces
a
pass­
fail
result,
the
concentration
of
these
standards
shall
be
determined
by
the
confirmed
operating
range
of
the
instrument,
regulatory
limits
and/
or
method
specified
levels.
Continuing
Calibration
Verification
Positive
(
CCV­
P)
with
lead
level
no
more
than
20%
above
the
applicable
regulatory
limit
(
omit
for
positive
screen
technologies)
and
Continuing
Calibration
Verification
Negative
(
CCV­
N)
with
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
33
lead
level
no
less
than
20%
below
the
applicable
regulatory
limit
(
omit
for
negative
screen
technologies).

d.
A
new
calibration
curve
shall
be
established
if
two
consecutive
test
results
of
one
continuing
calibration
check
are
outside
acceptable
limits.
When
the
continuing
calibration
check
is
confirmed
to
be
outside
acceptable
limits,
the
samples
affected
by
the
unacceptable
check
shall
be
reanalyzed
after
a
new
calibration
curve
has
been
established,
evaluated,
and
accepted.
Sample
analysis
shall
not
continue
or
be
restarted
until
a
new
calibration
curve
is
established
and
verified.

5.5.2.4
Continuing
Calibration
Blank
(
CCB)

Continuing
Calibration
Blank
(
CCB)
standards
shall
be
analyzed
in
accordance
with
the
testing
SOP.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
34
Table
1
Summary
of
Instrument
Calibration
Performance
Requirements
for
an
instrument
which
produces
a
numerical
result
QC
SAMPLE
FREQUENCY
ACCEPTANCE
LIMITS
Independent
Calibration
Verification
(
ICV)
Once
per
day
after
calibration
Within
±
10%
of
known
value
Initial
Calibration
Blank
(
ICB)
Once
per
run
at
the
beginning
of
the
run
Absolute
value
not
more
than
50
percent
of
the
lowest
regulatory
limit
for
the
sample
matrix
analyzed
or
minimum
level
of
concern
Continuing
Calibration
Verification
(
CCV)
Beginning
&
at
the
end
of
a
sample
run
as
well
as
every
12
hours,
or
according
to
instrument
manufacturer's
recommendations,
or
at
a
predetermined
SOP
frequency
whichever
is
most
frequent
Within
±
20%
of
known
value
Interference
Check
Sample
(
ICS)
(
where
applicable)
Beginning
&
end
of
each
run
or
twice
every
12
hours
Within
20%
of
known
value
Continuing
Calibration
Blank
(
CCB)
After
each
ICS
and
CCV
Absolute
value
not
more
than
50
percent
of
the
lowest
regulatory
limit
for
the
sample
matrix
analyzed
or
minimum
level
of
concern
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
35
Table
2
Summary
of
Instrument
(
or
Equivalent)
Performance
Requirements
for
an
instrument
(
or
equivalent)
which
produces
Pass­
Fail
result
QC
SAMPLE
FREQUENCY
ACCEPTANCE
LIMITS
Independent
Calibration
Verification
­
Positive
(
ICV­
P)
(
sample
lead
level
no
more
than
20%
above
the
applicable
regulatory
limit;
omit
for
positive
screen
technologies)
Once
per
run
at
the
beginning
of
the
run
Positive
Independent
Calibration
Verification
­
Negative
(
ICVN
(
sample
lead
level
no
less
than
20%
below
the
applicable
regulatory
limit;
omit
for
negative
screen
technologies)
Once
per
run
at
the
beginning
of
the
run
Negative
Initial
Calibration
Blank
(
ICB)
Once
per
run
at
the
beginning
of
the
run
Negative
Continuing
Calibration
Verification
Positive
(
CCV­
P)
(
sample
lead
level
no
more
than
20%
above
the
applicable
regulatory
limit;
omit
for
positive
screen
technologies)
At
the
end
of
a
run
as
well
as
every
12
hours,
or
according
to
the
manufacturer's
recommendations,
or
at
a
predetermined
SOP
frequency,
whichever
is
most
frequent
Positive
Continuing
Calibration
Verification
Negative
(
CCVN
(
sample
lead
level
no
less
than
20%
below
the
applicable
regulatory
limit;
omit
for
negative
screen
technologies)
At
the
end
of
a
run
as
well
as
every
12
hours,
or
according
to
the
manufacturer's
recommendations,
or
at
a
predetermined
SOP
frequency,
whichever
is
most
frequent
Negative
Interference
Check
Sample
(
ICS)
(
where
applicable)
At
the
beginning
and
end
of
each
run
or
twice
every
12
hours
Result
consistent
with
lead
level
Continuing
Calibration
Blank
(
CCB)
After
each
ICS
and
CCV
Negative
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
36
5.6
MEASUREMENT
TRACEABILITY
All
equipment
that
has
a
significant
effect
on
the
accuracy
or
validity
of
the
test
result
shall
be
calibrated
prior
to
use.
The
laboratory
shall
have
an
established
system
for
selecting,
using,
calibrating,
checking,
controlling
and
maintaining
measurement
standards,
reference
materials
and
equipment.

NLLAP
recognized
laboratories
shall
establish
and
use
a
program
for
the
calibration
of
equipment
to
ensure
traceability
to
the
Syst

me
International
(
SI)
units
of
measurement.
Traceability
of
measurement
shall
be
ensured
through
the
use
of
calibration
services
from
organizations
demonstrating
competence,
traceability
and
measurement
capability.
The
laboratory
shall
obtain
and
retain
in
its
record
system
calibration
certificates
from
these
organizations
showing
the
link
to
a
primary
standard
and
containing
the
measurement
results
including
measurement
uncertainty
and/
or
a
statement
of
compliance
with
an
identified
metrological
specification.

5.6.1
Reference
Standards
and/
or
Reference
Materials
Property
values
for
reference
materials
shall
be
traced
to
SI
units
of
measurement
wherever
possible.
The
reference
standards
and
materials
values
shall
be
certified
and
traceable
to
NIST
or
verified
against
NIST
standards
(
when
available).
Intermediate
calibration
checks
shall
be
carried
out
according
to
defined
procedures
and
schedules.
To
protect
the
integrity
of
the
reference
standards,
the
laboratory
shall
have
procedures
in
place
to
ensure
their
proper
handling,
transport,
storage,
and
use
of
reference
materials.
Reference
materials
shall
have
an
expiration
date
assigned.

Reference
materials
shall
not
be
used
beyond
assigned
expiration
dates
nor
used
if
damaged
or
contaminated
or
suspected
to
be
damaged
or
contaminated.
The
laboratory
shall
maintain
records
pertaining
to
all
reference
standards,
reference
materials
and
reagents
to
include
certificates
of
analysis,
purity,
their
origin
and
traceability,
as
provided
by
the
manufacturer,
for
a
period
of
at
least
three
years.

5.6.2
Documentation
of
Reagent
and
Calibration
Solution
Preparation
Documentation
of
intermediate
and
working
standard
and
reagent
solution
preparations
shall
be
kept
to
provide
traceability
and
shall
include
the
date
of
preparation,
identity
and
concentration
or
purity
of
parent
material,
assigned
expiration
date
and
preparer's
initials.
All
prepared
reagents
and
standards
shall
be
uniquely
identified
and
the
contents
shall
be
clearly
identified.

5.7
SAMPLING
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
37
When
the
laboratory
performs
sampling
of
dust,
paint
and/
or
soil
samples
as
a
part
of
testing
for
lead,
the
sampling
shall
be
performed
in
accordance
with:
40
CFR
Part
745
­
Lead­
Based
Paint
Activities
5.7.1
Sampling
Media
Where
the
laboratory
is
responsible
for
supplying
sampling
media,
the
media
shall
be
evaluated,
as
appropriate,
for
lead
contamination.
The
evaluation
process
shall
be
defined
in
a
SOP
and
results
of
evaluations
shall
be
recorded.

5.8
SAMPLE
HANDLING
The
laboratory
shall
have
written
SOPs
for
transportation,
receipt,
handling,
protection,
retention,
and/
or
disposal
of
the
samples,
including
provisions
necessary
to
protect
the
integrity
of
the
samples.

5.8.1
Sample
Control
Appropriate
space,
equipment
and
procedures
shall
be
provided
for
sample
receipt,
storage
and
processing.

5.8.2
Sample
Acceptance,
Documentation
and
Tracking
Procedures
These
procedures
shall
include
a
laboratory
identification
system
that
uniquely
identifies
each
sample
and/
or
batch
of
samples
received
by
the
laboratory.

5.8.2.1
Sample
Acceptance
Policy
The
laboratory
shall
have
a
written
sample
acceptance
policy
that
clearly
outlines
the
circumstances
under
which
samples
will
be
accepted
(
without
issuing
results
with
a
qualifier
in
the
associated
data
report).
Data
from
any
samples
which
do
not
meet
the
following
criteria
must
be
clearly
flagged
defining
the
nature
and
substance
of
the
variation.
This
sample
acceptance
policy
shall
be
made
available
to
sample
collecting
personnel
and
shall
include,
but
is
not
limited
to,
the
following
areas
of
concern:

a.
Proper,
full,
and
complete
documentation,
which
shall
include
sample
identification,
the
location,
date
of
collection,
sample
matrix
and
any
special
remarks
concerning
the
sample;

b.
Proper
sample
labeling
that
includes
unique
field
identification.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
38
c.
Use
of
appropriate
sample
containers;

d.
Adequate
quantity
of
sample
for
analysis.

5.8.2.2
Sample
Receipt
Logs
The
laboratory
shall
utilize
a
permanent
record,
such
as
a
log
book
or
electronic
record,
to
document
receipt
of
all
samples.
The
following
information
must
be
recorded:

a.
Date
of
laboratory
receipt
of
sample;

b.
Sample
collection
date
(
if
known);

c.
Unique
laboratory
ID
code
(
5.8.2.5);

d.
Field
ID
code
supplied
by
sample
submitter;

e.
Sample
matrix;

f.
Requested
analyses,
including
method
number,
if
applicable;

g.
Signature
or
initials
of
sample
receiver
(
where
applicable);
for
electronic
sample
logging
systems,
the
identity
of
the
sample
receiver;

h.
Comments
resulting
because
of
sample
rejection.

All
associated
documentation,
such
as
memos
or
transmittal
forms
that
are
transmitted
to
the
laboratory
by
the
sample
transmitter
shall
be
retained.

5.8.2.3
Documentation
on
Questionable
Samples
Where
there
is
any
doubt
as
to
the
suitability
of
the
sample
for
testing,
the
sample
does
not
conform
to
the
description
provided,
or
the
analysis
required
is
not
fully
specified,
the
laboratory
shall
consult
the
customer
for
further
instruction
before
proceeding.
If
the
sample
does
not
meet
the
sample
acceptance
criteria,
the
laboratory
shall:

#
Retain
correspondence
and/
or
records
of
conversations
concerning
the
final
disposition
of
rejected
samples
or
fully
document
any
decision
to
proceed
with
the
analysis
of
compromised
samples.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
39
#
The
condition
of
these
samples
shall,
at
a
minimum,
be
noted
on
the
chain
of
custody
or
transmittal
form
and
laboratory
receiving
documents.

#
The
associated
test
result
shall
be
appropriately
"
qualified"
on
the
final
report.

5.8.2.4
Sample
Custody
Procedures
The
use
of
legal
chain
of
custody
(
COC)
protocols
is
strongly
recommended
and
may
be
required
by
customers
and/
or
federal/
state/
tribal
programs
(
see
ASTM
D
4840
Standard
Guide
for
Sample
Chain
of
Custody
Procedures).
Chain
of
custody
records
shall
establish
an
intact,
continuous
record
of
the
physical
possession,
storage
and
disposal
of
collected
samples.

5.8.2.5
Sample
Tracking
The
laboratory
shall
have
a
documented
system
for
uniquely
identifying
the
items
to
be
analyzed,
to
ensure
traceability
of
items
and
to
ensure
that
there
can
be
no
confusion
regarding
the
identity
of
such
items
at
any
time.
This
system
shall
include
identification
of
all
samples,
subsamples,
and
subsequent
extracts
and/
or
digestates.
The
laboratory
shall
assign
a
unique
identification
(
ID)
code
to
each
sample
container
received
in
the
laboratory.
Multiple
aliquots
of
a
sample
that
have
been
received
for
testing
must
be
assigned
a
different
ID
code
(
such
as
a
prefix
or
suffix).

The
laboratory
sample
retention
and
disposal
policies
shall
be
documented
and
used.
The
policies
shall
include
documenting
the
manner
and
duration
of
sample
retention.
Laboratories
shall
comply
with
all
applicable
federal,
state
and
local
regulations
regarding
environmental
contamination
and
waste
disposal.

5.9
ASSURING
THE
QUALITY
OF
TEST
RESULTS
The
laboratory
is
responsible
for
ensuring
the
quality
of
the
test
results
through
the
monitoring
of
the
testing
process.
Such
monitoring
plans
shall
include:

#
internal
quality
control
approaches
using
statistical
techniques;

#
participation
in
interlaboratory
comparisons
or
proficiency
testing
programs;

#
regular
use
of
reference
materials;

#
replication
of
tests
using
the
same
or
different
methods;

#
re­
testing;

The
laboratory
quality
control
program
shall
include
the
continual
evaluation
of
its
performance:
determinations
of
bias
and
precision
for
each
matrix
analyzed;
and
participation
in
the
ELPAT
Program
for
each
matrix
analyzed.
Also
laboratories
are
encouraged
to
participate
in
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
40
interlaboratory
comparisons
and/
or
other
proficiency
testing
programs.

Laboratory
system
process
control
and
system
performance
monitoring
shall
be
accomplished
using
statistical
process
control
(
charts
or
data
base)
for
monitoring
the
laboratory's
performance
with
QC
sample
analysis
results.
The
statistical
process
control
method
used
shall
specify
warning
and
action
limits
for
acceptance
or
rejection
of
the
QC
data
and
shall
be
used
to
monitor
performance
trends
within
the
management
system
over
time.
In
the
absence
of
a
statistically
sufficient
data
base
to
determine
the
necessary
frequency
for
QC
samples
and/
or
action
limits
for
acceptance
or
rejection
of
QC
data,
the
laboratory
shall
use
of
the
frequencies
and
criteria
for
QC
samples
stated
in
Tables
3
and
4.

Note:
Tables
3
and
4
contains
the
required
minimum
performance
criteria
and
frequency
for
QC
sample
analysis
(
frequency
determinations
are
usually
based
on
system
process
control
data
produced
by
the
laboratory
for
the
method
in
question).
The
laboratory
shall
establish
its
own
performance
criteria
for
QC
samples
(
uncertainty
of
measurement),
which
shall
not
be
greater
than
stated
in
tables
3
and
4.

5.9.1
Quality
Control
Procedures.

The
laboratory
shall
have
QC
procedures
for
monitoring
the
validity
of
lead
tests
undertaken.
The
resulting
data
shall
be
recorded
in
such
a
way
that
trends
are
detectable
and
statistical
techniques
shall
be
applied
to
the
reviewing
of
the
results.
The
QC
procedures
shall
be
stated
in
the
quality
documents
such
as
QM
and/
or
in
each
method
SOP
addressing,
as
appropriate:

#
Duplicate
or
"
Side­
by­
Side"
Field
Sample
Analyses
#
Spiked
and
Blank
Sample
Analyses
#
Blind
Samples
#
Split/
Spiked
Field
Sample
Analyses
#
Control
Charts
or
Equivalent
#
Calibration
Standards
#
Laboratory
Control
Samples
#
Internal
Standards
5.9.1.1
Bias
Determination
Laboratory
Control
Samples
(
LCS).
LCSs
(
External
Reference)
are
used
to
determine
the
degree
of
bias
shall
be
of
the
same
matrix
as
the
test
samples,
and
shall
be
prepared
and
analyzed
with
a
minimum
frequency
of
one
per
twenty
field
samples
or
batch,
whichever
is
most
frequent.
A
batch
is
defined
as
a
set
of
samples
which
are
processed
(
for
example,
homogenized,
digested
and
analyzed)
in
one
operation.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
41
Note:
LCS
sources
include
but
are
not
limited
to:
proficiency
testing
samples
from
the
ELPAT
Program,
commercially
available
certified
reference
materials
(
CRM),
or
materials
of
known
concentration
determined
using
definitive
methods.
All
external
reference
sample
materials
shall
be
NIST
traceable.

For
an
instrument
which
produces
a
numerical
result,
the
lead
concentration
of
the
LCS
shall
be
near
the
level
of
concern
or
action
level
and
whenever
possible
shall
not
require
extensive
pretreatment
dilution
or
concentration
prior
to
analysis.

For
an
instrument
(
or
equivalent)
which
produces
a
pass­
fail
result,
the
lead
concentration
of
the
LCS
shall
be
near
the
level
of
concern
or
action
level,
but
no
more
than
20%
above
the
applicable
regulatory
limit
(
omit
for
positive
screen
technologies)
or
no
less
than
20%
below
the
applicable
regulatory
limit
(
omit
for
negative
screen
technologies)
and
whenever
possible
shall
not
require
extensive
pretreatment
dilution
or
concentration
prior
to
analysis.

Matrix
Spike
(
Split/
Spiked)
Field
Samples.
In
an
effort
to
evaluate
potential
matrix
interference,
a
matrix
spike
sample
shall
be
analyzed
with
a
minimum
frequency
of
5%
of
the
samples
for
each
matrix
type
per
batch
of
samples.
If
there
are
fewer
than
twenty
samples
in
a
batch,
at
least
one
matrix
spike
for
each
matrix
per
batch
shall
be
analyzed.

Matrix
spike
samples
shall
be
prepared
using
a
split
field
sample
(
before
any
digestion
process
when
possible)
and
the
level
of
lead
spiked
shall
be
enough
to
result
in
a
final
lead
concentration
of
the
prepared
sample
of
five
times
the
sample's
observed
lead
concentration,
or
five
times
the
method
detection
limit,
whichever
is
greater.

Matrix
spike
analyses
shall
be
performed
using
field
samples
(
whenever
possible)
in
order
to
monitor
for
potential
field
sample
matrix
interferences.
For
field
samples
too
small
or
difficult
to
homogenize
and
split
in
order
to
obtain
samples
for
matrix
spike
evaluation
or
replicate
analyses,
the
laboratory
shall
select
alternative
QC
options.
One
of
these
alternative
options
includes
the
analysis
of
duplicate
laboratory
control
samples,
prepared
with
the
appropriate
matrix
material,
for
each
batch.

Method
Blanks.
A
method
blank
containing
all
reagents
(
and
in
the
case
of
dust
wipes,
the
representative
blank
wipe)
and
subject
to
all
preparation
steps
shall
be
processed
and
analyzed
along
with
the
samples.
Method
blanks
shall
be
analyzed
with
a
minimum
frequency
of
5%
of
the
samples
for
each
matrix
per
batch
of
samples.
If
there
are
fewer
than
twenty
samples
in
a
batch,
at
least
one
method
blank
for
each
matrix
per
batch
shall
be
analyzed.
Method
blanks
(
or
other
QC
results)
shall
not
be
used
to
correct
sample
results.

5.9.1.2
Precision
(
repeatability)
Determination
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A
split
field
sample
(
the
initial
sample
being
split
into
two
fractions
before
digestion
and
analysis)
for
precision
determination
shall
be
analyzed
with
a
minimum
frequency
of
5%
of
the
samples
for
each
matrix
type
per
batch
of
samples.
If
there
are
fewer
than
twenty
samples
in
a
batch,
at
least
one
test
sample
for
each
matrix
per
batch
shall
be
analyzed.
For
analyses
where
there
is
not
a
sufficient
amount
of
field
sample
for
splitting
or
the
analytical
technology
does
not
allow
for
split
samples,
the
laboratory
shall
use
alternative
QC
procedures
in
an
effort
to
monitor
the
laboratory's
precision
of
analysis.
One
of
these
options
is
the
analysis
of
duplicate
laboratory
control
samples,
prepared
with
the
appropriate
matrix
material,
for
each
batch
in
order
to
monitor
laboratory
performance.

Table
3
Summary
of
QC
Sample
Performance
Requirements
for
an
instrument
which
produces
a
numerical
result
QC
SAMPLE
FREQUENCY
ACCEPTANCE
LIMITS
Laboratory
Control
Sample
One
per
20
samples
or
batch
(
min.
frequency
5%)
Within
±
20%
of
known
value
Matrix
Spike
Sample
One
per
20
samples
or
batch
(
min.
frequency
5%)
Within
±
25%
of
calculated
value
Duplicate
Sample
One
per
20
samples
or
batch
(
min.
frequency
5%)
Within
±
25%
Relative
Percent
Difference
(
RPD)

Method
Blank
One
per
20
samples
or
batch
(
min.
frequency
5%)
Absolute
value
not
more
than
50
percent
of
the
lowest
regulatory
limit
for
the
sample
matrix
analyzed
or
minimum
level
of
concern
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Table
4
Summary
of
QC
Sample
Performance
Requirements
for
an
instrument
(
or
equivalent)
which
produces
Pass­
Fail
result
QC
SAMPLE
FREQUENCY
ACCEPTANCE
LIMITS
Laboratory
Control
Sample
Positive
LCS­
P
(
sample
lead
level
no
more
than
20%
above
the
applicable
regulatory
limit;
omit
for
positive
screen
technologies)
One
per
20
samples
or
batch
(
min.
frequency
5%)
Positive
Laboratory
Control
Sample
Negative
LCS­
N
(
sample
lead
level
no
less
than
20%
below
the
applicable
regulatory
limit;
omit
for
negative
screen
technologies)
One
per
20
samples
or
batch
(
min.
frequency
5%)
Negative
Duplicate
Laboratory
Control
Sample
LCS­
P
or
LCS­
N
One
per
20
samples
or
batch
(
min.
frequency
5%)
Positive
or
Negative,
depending
on
the
choice
of
lead
level
and
the
capability
of
the
technology
Method
Blank
One
per
20
samples
or
batch
(
min.
frequency
5%)
Negative
5.9.2
Control
Charts
or
Quality
Control
Data
Base
Control
charts
or
a
quality
control
data
base
shall
be
used
to
record
quality
control
data
and
track
laboratory
performances
with
respect
to
the
associated
acceptance
limits
for
each
matrix.
The
performance
tracking
of
critical
QC
samples
shall
be
done
as
close
as
possible
on
a
real
time
basis.

5.9.3
Procedures
for
determination
of
out
of
control
situations
The
laboratory
shall
implement
general
procedures
to
be
followed
to
determine
when
quality
control
data
is
out
of
control.
These
procedures
shall
address
the
following
:

a.
Assigning
responsibility
for
assessing
each
QC
data
type;
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b.
Assigning
responsibility
for
initiating
and/
or
recommending
corrective
actions;

c.
Defining
how
the
analyst
should
treat
a
data
set
if
the
associated
QC
measurements
are
unacceptable;
and
d.
Specifying
how
out­
of
control
situations
and
subsequent
corrective
actions
are
to
be
documented.

When
QC
sample
results
fall
outside
the
acceptance
limits,
the
affected
batch
of
samples
shall
be
reanalyzed,
whenever
possible.
The
re­
analysis
shall
begin
with
the
sample
preparation
stage,
when
applicable,
and
shall
include
a
new
set
of
QC
samples,
when
possible.
When
feasible,
a
lead
laboratory
may
arrange
for
the
re­
collection
or
re­
taking
of
field
samples.

5.10
REPORTING
THE
RESULTS
5.10.1
General
Results
of
test
activities
carried
out
by
the
NLLAP
recognized
laboratory
shall
be
reported
clearly
and
objectively.
These
test
results
shall
be
reported
in
a
test
report
that
includes
all
the
information
needed
for
the
interpretation
of
the
test
results
and
required
by
the
test
method
used,
as
well
as
any
additional
information
requested
by
the
customer.

When
tests
are
performed
for
internal
customers,
or
by
customer
request,
the
results
may
be
reported
in
a
simplified
manner
upon
written
agreement
with
the
customer.
In
this
case,
the
information
listed
in
5.10.2
that
is
not
reported
shall
be
easily
accessed
in
the
laboratory
that
performed
the
tests.

5.10.2
Test
Reports
Final
test
reports
shall
contain,
at
a
minimum,
the
information
outlined
below.
The
customer
may
request
additional
information
to
be
included
in
the
report.
Along
with
the
final
test
report,
the
laboratory
shall
maintain
a
sample
case
file
or
be
able
to
assimilate
the
sample
case
information
described
in
this
document
for
a
period
of
at
least
three
years
after
the
final
test
report
is
issued.
It
is
also
recommended
that
the
document
include
a
clause
stating
that
the
test
report
is
not
to
be
reproduced
except
in
full
without
written
approval
of
the
laboratory.

Each
report
shall
include
at
least
the
following
information:

a.
title,
e.
g.,
"
Test
Report",
or
"
Report
of
Results"
or
"
Laboratory
Results";

b.
name
and
address
of
laboratory,
location
where
the
analysis
was
carried
out,
if
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different
from
the
address
of
the
laboratory,
and
name
and
phone
number
of
contact
person
for
questions;

c.
unique
identification
of
the
report
(
such
as
serial
number)
and
of
each
page,
the
total
number
of
pages,
and
a
clear
identification
of
the
end
of
the
report;

d.
name
and
address
of
customer,
where
appropriate,
and
project
name
if
applicable;

e.
description,
condition,
and
clear
identification
of
the
analyzed
samples;

f.
date
of
receipt
of
the
sample(
s);

g.
identification
of
the
validated
analytical
method
used;

h.
any
deviations
from,
additions
to,
or
exclusions
from
the
analytical
method,
and
any
other
information
relevant
to
a
specific
analytical
method,
such
as
environmental
conditions
including
the
use
of
relevant
data
qualifiers;

i.
identification
of
the
standard(
s)
or
specification(
s)
relevant
to
the
test
(
when
required
by
customer);

j.
where
necessary,
a
statement
of
compliance/
non
compliance
with
requirements
and/
or
specifications;

k.
analytical
test
results,
supported
by
tables,
graphs,
sketches,
and
photographs
as
appropriate,
with
units
of
measurement;
and
any
failures
identified;
and
identification
of
the
reporting
limit
and
reporting
units
(
such
as
mg/
kg
with
identification
of
whether
data
is
calculated
on
a
dry
weight
or
wet
weight
basis);

l.
a
signature
and
title,
or
an
equivalent
identification,
of
the
person(
s)
accepting
responsibility
on
behalf
of
the
laboratory
for
the
content
of
the
report
(
however
produced),
and
date
of
issue;

m.
where
relevant,
a
statement
to
the
effect
that
the
results
relate
only
to
the
items
analyzed;

n.
where
appropriate
and
needed,
opinions
and
interpretations
including
synopsis
of
analytical
quality
control
results
focusing
on
any
quality
control
sample
measurements
that
did
not
meet
the
method
specified
requirements;

o.
reference
to
sampling
procedure,
where
relevant;
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46
p.
statement
on
the
estimated
uncertainty
of
the
measurement
when
the
uncertainty
affects
reported
lead
result
or
is
required
by
the
customer.

In
addition
to
the
requirements
listed
above,
test
reports
containing
the
results
of
sampling
shall
include
the
following,
if
available:

a.
the
date
of
sampling;

b.
location(
s)
of
sampling,
including
any
relevant
diagrams,
sketches,
or
photographs;

c.
reference
to
the
specific
sampling
plan
used;

d.
detailed
environmental
conditions
present
during
sampling
that
may
affect
the
interpretation
of
the
test
results;

e.
identification
of
the
sampling
method
or
procedure
used;

f.
protocols
or
specifications
used
for
the
sampling
methods
or
procedures,
as
well
as
any
deviations
from,
additions
to,
or
exclusions
from
the
specification
concerned.

5.10.2.1
Reporting
Results
Below
the
Quantitation
Limit
Report
of
zero
concentration
is
not
permitted.
Laboratories
shall
establish
a
method
of
limiting
the
lower
reported
values
to
a
positive
finite
lead
level
that
is
appropriate
for
the
technology
being
used.
Measured
lead
levels
below
this
positive
finite
value
shall
be
reported
with
a
qualifier
"
less
than"
("<")
this
positive
finite
value.

For
pass­
fail
technologies,
clear
statement
of
measurement
capability
with
associated
uncertainty
shall
be
reported
to
the
customer.

5.10.2.2
Opinions
and
Interpretations
When
opinions
and
interpretations
are
included
in
the
test
report,
the
laboratory
shall
be
able
to
show
that
it
has
documented
the
basis
upon
which
the
opinions
and
interpretations
have
been
made.
Examples
of
opinions
and
interpretations
that
might
be
included
in
a
test
report
are
recommendations
on
how
to
use
results,
guidance
for
improvement,
and
conformity
of
results
with
requirements.
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5.10.3
REPORT
REVIEW
AND
APPROVAL
PROCESS
All
final
test
reports
shall
undergo
the
documented
data
review
process
before
release
to
the
customer.
If
a
qualified
person
who
was
not
involved
in
the
physical
preparation
or
analysis
of
samples
in
question
is
available
to
review
the
final
report,
than
that
person
shall
conduct
the
review.
Qualified
persons
can
be
technicians,
analysts,
the
quality
manager,
or
technical
manager,
or
the
responsible
person
described
previously
in
Section
4.0.

In
the
case
of
a
one
person
laboratory,
or
where
a
qualified
person
is
not
available
for
the
review,
the
following
options
may
be
followed
to
complete
the
review.

Option
1.
The
review
process
may
be
conducted
under
using
an
SOP
that
is
part
of
the
laboratory's
management
system.

Option
2.
The
review
process
may
be
contracted
out
if
the
SOP
above
is
followed.

The
review
process
shall
be
documented
and
signed
by
the
reviewer,
and
shall
be
retained
on
file
with
a
copy
of
the
final
report
for
a
minimum
of
three
years.

5.10.4
TEST
REPORT
CORRECTION
PROCESS
5.10.4.1
Corrections
and
Amendments
to
Test
Reports
If
corrections
or
additions
to
a
test
report
are
made,
they
shall
be
documented
and
the
report
reissued
as
an
amended
report.

Once
a
test
report
has
been
issued,
material
amendments
shall
be
made
only
in
the
form
of
a
further
document
or
data
transfer
that
is
clearly
identified
as
a
supplement
to
the
original.
When
issuance
of
a
complete
new
report
is
warranted,
it
shall
be
uniquely
identified
and
shall
contain
a
reference
to
the
original
it
replaces.

5.10.4.2
Test
Results
Obtained
from
Subcontractors
Test
results
obtained
from
subcontractors
shall
be
clearly
identified
in
the
test
report.
The
subcontracted
laboratory
or
organization
must
be
currently
NLLAP
recognized
for
the
subcontracted
test
methods
in
question.

5.10.4.3
Electronic
Transmission
of
Results
When
transmitting
test
results
via
telex,
facsimile,
telephone,
or
other
electronic
or
electromagnetic
means,
the
requirements
in
4.12.3
of
this
document
must
be
met.
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NLLAP
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49
APPENDIX
I
ACRONYMS
AND
GLOSSARY
OF
TERMS
ASSOCIATED
WITH
THE
NLLAP
Acronyms
ACS
American
Chemical
Society
AIHA
American
Industrial
Hygiene
Association
ASTM
American
Society
for
Testing
and
Materials
ANSI
American
National
Standards
Institute
CCB
Continuing
Calibration
Blank
CCV
Continuing
Calibration
Verification
CDC
Centers
for
Disease
Control
COC
Chain
of
Custody
ELPAT
Environmental
Lead
Proficiency
Analytical
Testing
(
AIHA/
NIOSH)
EPA
Environmental
Protection
Agency
HUD
Housing
and
Urban
Development
ICB
Initial
Calibration
Blank
ICV
Independent
Calibration
Verification
ICS
Interference
Check
Standard
ISO
International
Organization
for
Standardization
ISO­
IEC
International
Organization
for
Standardization
and
International
Electrochemical
Commission
LCS
Laboratory
Control
Sample
MDL
Method
Detection
Limit
MOU
Memorandum
of
Understanding
MSM
Management
System
Manual
NIOSH
National
Institute
for
Occupational
Safety
and
Health
NIST
National
Institute
of
Standards
and
Technology
NLLAP
National
Lead
Laboratory
Accreditation
Program
OPPT
Office
of
Pollution
Prevention
and
Toxics
PE
Performance
Evaluation
PT
Proficiency
Testing
QA
Quality
Assurance
QC
Quality
Control
RE
Relative
Error
RPD
Relative
Percent
Difference
SAP
Sample
Analysis
Plan
SI
Syst

me
International
units
of
measurement
SOP
Standard
Operating
Procedure
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50
SRM
Standard
Reference
Material
Produced
by
NIST
TSCA
Toxic
Substances
Control
Act
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51
Glossary
Accreditation:
A
formal
recognition
that
an
organization
(
e.
g.,
laboratory)
is
competent
to
carry
out
specific
tasks
or
specific
types
of
analyses.

Accredited
laboratory:
A
laboratory
that
has
been
evaluated
and
given
approval
to
perform
a
specified
analysis
or
task,
usually
for
a
specific
property
or
analyte
and
for
a
specified
period
of
time.

Acceptance
limits:
Data
quality
limits
specified
by
the
National
Lead
Laboratory
Accreditation
Program
for
analytical
method
performance.

Accuracy:
The
degree
of
agreement
between
an
observed
value
and
an
accepted
reference
value.
Accuracy
includes
a
combination
of
random
error
(
precision)
and
systematic
error
(
bias)
components
which
are
due
to
sampling
and
analytical
operations;
a
data
quality
indicator.
See
Precision
and
Bias.

Aliquot:
See
Subsample.

Batch:
A
quantity
of
material
produced
or
processed
(
in
example,
homogenized,
digested
and
analyzed)
in
one
operation,
considered
to
be
a
uniform,
discrete
unit.

Bias:
The
systematic
error
manifested
as
a
consistent
positive
or
negative
deviation
from
the
known
true
value.

Blind
sample:
A
subsample
submitted
for
analysis
with
a
composition
and
identity
known
to
the
submitter
but
unknown
to
the
analyst
and
used
to
test
the
analyst's
or
laboratory's
proficiency
in
the
execution
of
the
measurement
process.

Calibrate:
To
determine,
by
measurement
or
comparison
with
a
standard,
the
correct
value
of
each
scale
reading
on
a
meter
or
other
device,
or
the
correct
value
for
each
setting
of
a
control
knob.
The
levels
of
the
calibration
standards
should
bracket
the
range
of
planned
measurements.
See
Calibration
curve.

Calibration
blank:
See
Initial
calibration
blank.

Calibration­
check:
See
Calibration
verification.
NLLAP
LQSR
Rev.
3.0
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52
Calibration­
check
standard:
See
Calibration
verification.

Calibration
curve:
The
graphical
relationship
between
the
known
values
for
a
series
of
calibration
standards
and
instrument
responses.

Calibration
drift:
The
difference
between
the
instrument
response
and
a
reference
value
after
a
period
of
operation
without
recalibration.
See
Continuing
calibration
verification.

Calibration
standard:
A
substance
or
reference
material
used
to
calibrate
an
instrument.

Calibration
solution:
See
Calibration
standard.

Calibration
verification:
See
Initial
or
continuing
calibration
verification.

Certified
Reference
Material:
A
reference
material
that
has
one
or
more
of
its
property
values
established
by
a
technically
valid
procedure
and
is
accompanied
by
or
traceable
to
a
certificate
or
other
documentation
issued
by
a
certifying
body.
See
Certification
and
Reference
material.

Chain
of
custody
(
COC):
An
unbroken
trail
of
accountability
that
insures
the
physical
security
of
samples,
data,
and
records.

Check
sample:
An
uncontaminated
sample
matrix
spiked
with
known
amounts
of
analytes,
usually
from
the
same
source
as
the
calibration
standards.
It
is
generally
used
to
establish
the
stability
of
the
analytical
system,
but
may
also
be
used
to
assess
the
performance
of
all
or
a
portion
of
the
measurement
system.
See
also
Quality
control
sample.

Composite
sample:
A
sample
composed
as
a
result
of
collection
of
more
than
one
sample
of
the
same
medium
(
e.
g.,
dust)
from
the
same
type
of
surface
(
e.
g.,
floor,
interior
window
sill,
or
window
trough)
so
that
multiple
samples
can
be
analyzed
as
a
single
sample.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
53
Continuing
Calibration
Blank
(
CCB):
A
standard
solution
which
has
no
analyte
and
is
used
to
verify
blank
response
and
freedom
from
carryover.
The
CCB
should
be
analyzed
after
the
CCV
and
after
the
Interference
Check
Standard
(
ICS).

Continuing
Calibration
Verification
(
CCV):
A
standard
solution
(
or
set
of
solutions)
used
to
verify
freedom
of
excessive
instrumental
drift.
The
concentration
to
be
near
midrange
of
linear
curve.
The
CCV
should
be
matrix
matched
to
acid
content
present
in
sample
digestates.
The
CCV
should
be
analyzed
before
and
after
all
sample
digests.

Control
chart:
A
graph
of
some
measurement
plotted
over
time
or
sequence
of
sampling,
together
with
control
limit(
s)
and,
usually,
a
central
line
and
warning
limit(
s).

Control
sample:
See
Laboratory
control
sample.

Corrective
action:
Action
taken
to
correct
a
deficiency
noted
in
a
technical
systems
audit.
See
Deficiency
and
Systems
audit.

Deficiency:
A
failure
to
fully
comply
with
the
requirements
of
NLLAP
usually
noted
during
a
technical
systems
audit.
See
NLLAP
and
Systems
audit.

ELPAT:
Environmental
Lead
Proficiency
Analytical
Testing
Program.
Successful
participation
in
this
proficiency
testing
program
on
a
semi­
annual
basis
is
required
for
all
EPA/
NLLAP
recognized
laboratories.
ELPAT
Program
is
administered
by
AIHA
in
cooperation
with
NIOSH
and
EPA.

Initial
calibration
blank
(
ICB):
A
standard
solution
that
contains
no
analyte
and
is
used
for
initial
calibration
and
zeroing
instrument
response.
The
ICB
must
be
matrix
matched
to
acid
content
present
in
sample
digestates.
The
ICB
should
be
measured
during
calibration
and
after
calibration.

Independent
calibration
verification
(
ICV):
A
standard
solution
(
or
set
of
solutions)
used
to
verify
calibration
standard
levels.
Concentration
of
analyte
to
be
near
mid­
range
of
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
54
linear
curve
which
is
made
from
a
stock
solution
having
a
different
manufacturer
or
manufacturer
lot
identification
than
the
calibration
standards.
The
ICV
must
be
matrix
matched
to
acid
content
present
in
sample
digestates.
The
ICV
should
be
measured
after
calibration
and
before
measuring
any
sample
digestates.

Instrument:
An
instrument
which
produces
a
quantitative
(
numerical
result)
performs
a
measurement
of
lead
that
can
be
quantified
numerically
or
an
instrument
(
or
equivalent)
which
produces
qualitative
(
passfail
result
performs
a
measurement
that
indicates
the
absence
or
presence
of
lead
relative
to
a
given
threshold
level.

Interference
check
standard
(
ICS):
A
standard
solution
(
or
set
of
solutions)
used
to
verify
accurate
analyte
response
in
the
presence
of
possible
interferences
from
other
analytes
present
in
samples.
The
ICS
must
be
matrix
matched
to
the
reagent
content
present
in
sample
digestates.

Internal
quality
control:
The
routine
activities
and
checks,
such
as
periodic
calibrations,
duplicate
analyses,
and
spiked
samples,
that
are
included
in
normal
internal
procedures
to
control
the
accuracy
and
precision
of
measurements.

Internal
standard:
A
standard
added
to
a
test
portion
of
a
sample
in
a
known
amount
and
carried
through
the
entire
demonstration
procedure
as
a
reference
for
calibration
and
controlling
the
precision
and
bias
of
the
applied
analytical
method.

Laboratory:
Any
operation
that
performs
quantitative
and/
or
qualitative
analytical
testing
of
paint
chip
(
film),
dust,
and/
or
soil
samples
for
lead
analysis
regardless
of
the
number
of
personnel
or
the
extent
of
the
scope
of
testing
activities.
Laboratory
control
sample
(
LCS):
A
matrix­
based
reference
material
with
an
established
concentration
obtained
from
a
source
independent
of
the
instrument
calibration
and
traceable
to
NIST
or
other
reference
materials.
The
LCS
is
carried
through
the
entire
procedure
from
digestion
through
analysis
as
a
field
sample.
The
purpose
of
the
LCS
is
to
evaluate
bias
of
the
method.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
55
Laboratory
systems
audit:
See
Systems
audit.

Lot:
A
set
of
samples
submitted
together
for
laboratory
analysis
which
can
be
treated
as
one
or
more
batches.
Matrix:
The
component
or
substrate
which
contains
the
analyte
of
interest.

Matrix
spike:
See
Spiked
sample.

Method
blank:
A
mixture
of
all
reagents
used
for
the
digestion
of
paint,
soil,
or
dust
matrices
but
without
the
matrix.
This
blank,
is
carried
through
all
steps
of
the
analysis
starting
with
the
digestion
step.
This
blank
evaluates
the
process
for
contamination
from
the
laboratory.

Method
performance:
A
general
term
used
to
document
the
characteristics
of
a
method.
These
characteristics
usually
include
method
detection
limits,
linearity,
precision,
accuracy
and
bias.
The
minimum
acceptable
criteria
for
method
performance
characteristics
are
determined
and/
or
verified
as
part
of
method
validation,
method
measurement
uncertainty
determination
and
method
performance
demonstrations.

Method
detection
limit
(
MDL):
The
minimum
concentration
of
an
analyte
that,
in
a
given
matrix
and
with
a
specific
method,
has
a
99%
probability
of
being
identified,
qualitatively
or
quantitatively
measured,
and
reported
to
be
greater
than
zero.

NLLAP:
National
Lead
Laboratory
Accreditation
Program.
This
EPA
program
recognizes
laboratories
which
have
demonstrated
they
are
capable
of
analyzing
paint
chip
(
film),
dust
and/
or
soil
samples
for
lead.

NLLAP
requirements:
Requirements
specified
by
the
EPA
National
Lead
Laboratory
Accreditation
Program
(
NLLAP)
in
order
to
be
accredited
for
lead
analysis
in
paint
chip
(
film),
dust,
and/
or
soil
matrices
by
an
EPArecognized
laboratory
accreditation
organization.
(
NLLAP
requirements
are
designed
to
be
used
for
accreditation
purposes
and
should
not
be
used
for
purpose
of
verification/
validation
of
any
specific
technology).
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
56
Precision
(
repeatability):
The
degree
to
which
a
set
of
observations
or
measurements
of
the
same
property,
usually
obtained
under
similar
conditions,
conform
to
themselves;
a
data
quality
indicator.
Precision
is
usually
expressed
as
standard
deviation,
variance,
or
range,
in
either
absolute
or
relative
terms.

Proficiency
testing:
A
systematic
program
in
which
one
or
more
standardized
samples
is
analyzed
by
one
or
more
laboratories
to
determine
the
capability
of
each
participant.

Quality
assurance
(
QA):
An
integrated
system
of
activities
involving
planning,
quality
control,
quality
assessment,
reporting,
and
quality
improvement
to
ensure
that
a
product
or
service
meets
defined
standards
of
quality
within
a
stated
level
of
confidence.

Quality
control
(
QC):
The
overall
system
of
technical
activities
whose
purpose
is
to
measure
and
control
the
quality
of
a
product
or
service
so
that
it
meets
the
needs
of
users.
The
aim
is
to
provide
quality
that
is
satisfactory,
adequate,
dependable,
and
economical.

Quality
manager:
The
manager
of
the
quality
system.
The
quality
manager
is
independent
of
the
analyst
and
reports
directly
to
management.

Quantitation
Limits:
The
maximum
or
minimum
levels
or
quantities
of
a
target
analyte
that
can
be
quantified
to
a
specified
accuracy.

Reference
material:
A
material
or
substance,
one
or
more
properties
of
which
are
sufficiently
well
established
to
be
used
for
the
calibration
of
an
apparatus,
the
assessment
of
a
measurement
method,
or
assigning
values
to
materials.

Reference
standard:
See
Calibration
standard.

Relative
percent
difference:
A
term
defined
as:
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
57
where
|
R1

R2
|
represents
the
absolute
difference
in
two
values
and
R
represents
the
average
of
the
two
values.

Run:
A
set
of
consecutive
sample
measurements.

Sample
log:
The
document
where
sample
identification,
condition,
etc
is
noted
when
samples
arrive
at
the
laboratory.
The
log
is
part
of
the
sample
tracking
system.
See
Sample
tracking.

Sample
tracking:
A
system
of
following
a
sample
from
receipt
at
the
laboratory,
through
sample
processing
and
analysis,
and
to
final
reporting.
The
system
includes
unique
numbering
or
bar
coding
labels
and
the
use
of
a
sample
log.

Site
inspection/
assessment:
An
on­
site
visit
to
a
laboratory
for
the
purpose
of
conducting
a
systems
audit.

Spiked
sample:
A
sample
prepared
by
adding
a
known
mass
of
target
analyte
to
a
specified
amount
of
matrix
sample
for
which
an
independent
estimate
of
target
analyte
concentration
is
available.
Spiked
samples
are
used,
for
example,
to
determine
the
effect
of
the
matrix
on
a
method's
recovery
efficiency.

Split
samples:
Two
or
more
representative
portions
taken
from
a
sample
or
subsample
and
analyzed
by
different
analysts
or
laboratories.
Split
samples
are
used
to
replicate
the
measurement
of
the
variable(
s)
of
interest.

Standard
operating
procedure
(
SOP):
A
written
document
that
details
the
method
of
an
operation,
analysis,
or
action
whose
techniques
and
procedures
are
thoroughly
prescribed
and
which
is
accepted
as
the
method
for
performing
certain
routine
or
repetitive
tasks.
NLLAP
LQSR
Rev.
3.0
8/
XX/
05
DRAFT
58
Standard
reference
material
(
SRM):
A
certified
reference
material
produced
by
the
U.
S.
National
Institute
of
Standards
and
Technology
and
characterized
for
absolute
content
independent
of
analytical
method.

Standardization:
The
process
of
establishing
the
quantitative
relationship
between
a
known
mass
of
target
material
(
e.
g.,
concentration)
and
the
response
variable
(
e.
g.,
the
measurement
system
or
instrument
response).
See
Calibrate
and
Calibration
curve.

Stock
solution:
A
concentrated
solution
of
analyte(
s)
or
reagent(
s)
prepared
and
verified
by
prescribed
procedure(
s),
and
used
for
preparing
working
standards
or
standard
solutions.

Subsample:
A
representative
portion
of
a
sample.

Systems
audit:
A
thorough
systematic
on­
site,
qualitative
review
of
facilities,
equipment,
personnel,
training,
procedures,
record
keeping,
data
validation,
data
management,
and
reporting
aspects
of
a
total
measurement
system.

Traceability:
An
established
property
of
the
result
of
a
measurement,
to
stated
references
(
usually
national
or
international
standards)
at
a
stated
level
of
uncertainty
through
an
unbroken
chain
of
comparisons.

Validation:
The
process
of
substantiating
specified
performance
criteria.
