Ask The Expert Webinar Series

DoD ELAP and the DoD/DOE QSM -

A Laboratory Perspective

Larry Penfold – Quality Compliance Director

Topics for Discussion

• DoD Laboratory Accreditation Program (ELAP) Consolidation and streamlining

Inappropriate Practices Memo

Success of ELAP

• Status of the DoD/DOE QSM Version 5.0 • Audits

• Challenge using multiple versions of QSM

• “No blanket variances”

• Expected changes & schedule for QSM Version 5.1

DoD Environmental

Laboratory Accreditation

Program (ELAP)

DoD ELAP

• DoD ELAP continues to employ 3rd-party

Accreditation Bodies (ABs) to assess and

accredit laboratories

• Currently are 3 ABs, there were 4 in 2015 ANSI-ASQ National Accreditation Board (ANAB),

dba L-A-B

American Association for Laboratory Accreditation

(A2LA)

Perry Johnson Laboratory

Accreditation, Inc. (PJLA)

Note: DOE assesses labs separately under

the Consolidated Audit Program (DOECAP)

Trends in DoD ELAP

• Currently 93 laboratories in the program, there

were 100 in 2015

• Scopes of accredited methods continue to be

streamlined by labs to conform to market

demand, for example:

Dropping EPA, ASTM, and Std. Methods used for

CWA compliance

Dropping EPA drinking water methods

Expanding specialty methods, PFOA/PFOS, air,

and radiochemistry

Where To Find Latest

Laboratory Accreditation Info

• DENIX website

http://www.denix.osd.mil/edqw

• DENIX provides list of accredited labs

searchable by method and matrix

• Links are provided to AB websites, with

• Scopes showing accredited analytes

• Certificates with effective date and expiration date

• Lab addresses and contact information

Trends in DoD ELAP

(continued)

• At 2016 EDQW workshop, informed EDQW has seen

an increase in reported incidents of inappropriate

laboratory practices

• QSM 5.0 Section 5.2.7 Fabrication or misrepresentation of data

Improper clock setting or date/time recording

Unwarranted manipulation of samples, software, or

analytical conditions

Misrepresenting or misreporting QC samples

Improper calibrations

Concealing known analytical or sample problem

Concealing known improper or unethical behavior or action

Failing to report prohibited practice or unethical act

“Inappropriate Practices”

Memo • Released in early 2016

• What does it mean?

• If a lab conducts investigation into potential

inappropriate practice, even if not willful intent to

misrepresent, we will notify our AB

• QSM 5.1 will require notification to AB’s within 30 days

• AB will notify EDQW

• Thorough and transparent investigation

• Labs notify clients, long been TestAmerica’s policy

• 6 instances communicated to EDQW as of late March

2016, 4 were confirmed problems

DoD ELAP Successes

• Uniform standard consolidating requirements

applicable to all branches of the DoD & DOE

• Requirement to analyze PTs for any

analyte/matrix commercially available

• Active oversight of ABs and labs

• New auditors observed by EDQW

• Full audit every 2 years with annual surveillance

• Higher quality laboratory assessments

Status of DoD/DOE Quality

Systems Manual (QSM)

Version 5.0

Laboratory Audits

• By January 2016 all labs performing work for the

DoD had been audited to QSM 5.0

• Labs in DOE program audited by DOECAP, audits

with QSM5-based checklist conducted this year

• Why two audit programs?

DOECAP is required to include elements not covered

by DoD ELAP:

Health & Safety

Radiological materials handling

Hazardous waste management

Increasing Challenge for

Laboratories

• QSM 5.1 – effective January 2017

• QSM 5.0 - current version

• QSM 4.1 & 4.2 – actively used for on-going projects

• Labs can have multiple projects running

simultaneously requiring different versions of QSM

Labs need rugged systems to keep track of many versions

e.g., training, special codes & instructions in LIMS

“No Blanket Variances” Announced in

2016 EDQW Workshop

• Some have interpreted this as a change, & that

variances to the QSM are no longer allowed

• What does it mean? Simply that no variance is

approved for any and all projects

• This a clarification, and not a change!

• DoD’s position has always been

1. Lab accreditation requires documented ability to

meet all QSM requirements, but also

2. Deviations from QSM are accepted if consistent

with project objectives and approved by the project

team

Variances (continued)

• QSM 5.1 will state that variances require

written approval from a project chemist (DoD

or prime contractor) and require technical

justification

• But EDQW wants labs to work with project

team to develop an optimal technical

approach

How does that work?

TestAmerica’s Technical

Specifications Document

• Submitted with bids and proposals, tailored

to methods required for the project

• Proposed analytical approach to help

facilitate an efficient and smooth running

project

• All subject to discussion and approval with

project chemist before receiving samples

Technical Specifications

Document (continued)

• Many elements would never be interpreted

as variances, but should be discussed in

advance (e.g., identifying common lab contaminants)

• Some options frequently considered

reasonable and acceptable to data validators (e.g., reporting qualified ND sample results with high CCV)

• Some elements deal with non-routine analytes,

poor performers, as shown in next slide

A Few Examples of 8260 CCV Limits

Inconsistent With LCS Limits

Method 8260 LCS is functionally identical to CCV

Important to work with lab to establish criteria if poor

performing compounds included in project !

Starting 12-hr Ending LCS

Analyte CCV Limit CCV Limit Limit

% recovery % recovery % recovery

1,3-Butadiene 80-120 50-150 43-158

2-Methylnapthalene 80-120 50-150 17-142

Acetone 80-120 50-150 39-160

Acrolein 80-120 50-150 39-155

QSM 5.1 Expected

Changes and Schedule

QSM 5.1 Expected Changes

• Laboratory notification to ABs and clients if

inappropriate and prohibited practices found

• Clarification on need from written approval from

project chemists and technical justification for

variances

• New tables for specialty methods Air methods using GC/MS, e.g., TO-14 and TO-15

Selective ion monitoring (SIM) GC/MS 8270

Bulk soil preparation by Incremental Sampling

Methodology (ISM)

Explosives by LC/MS and LC/MS/MS, e.g., 8321

Revisions to tables for PFOA/PFOS by LC/MS/MS

QSM 5.1 Changes

(continued)

• Metals

ICB/CCB limits < ½*LOQ, rather than < LOD

Change to criteria for PDS

Low-level check standard for CVAA, GFAA, & FAA

• Volatile Organics

Single-point calibration acceptable for surrogates

• Dioxins/Furans

Reporting Total Toxic Equivalent (TEQ) based on EDL,

EQL, and EMPC (rather than DL, LOD, and LOQ)

QSM 5.1 Changes

(continued) • Radiochemistry

Detection Limit (DL) must be based on Combined

Standard Uncertainty (i.e., MDC at 1 standard

deviation), rather than MDL or simple counting

statistics

Liquid Scintillation Counting (LSC) quench curve

required for determination of subtraction

backgrounds

Methods without preparatory physical or chemical

steps (e.g., gamma spectrometry, C-14 ghost

wipes, alpha/beta air filters), CCV can be used as

an LCS

DOE chemists working on more changes

QSM 5.1 Expected Schedule

• July 2016 - DOE to complete changes for

radiochemistry methods

• July 2016 – EDQW principals to complete review

of changes to non-rad methods and general

requirements

• September 2016 – Presentation of QSM 5.1 to

ELAP community for comments

• January 2017 publication and application to new

projects

Factors for Success

Keys To A Successful

Project

• Engage the lab during project planning phase!

• Work with a lab that:

– Knows the program

– Is adept at working with client to fit practical approach

to project objectives

– Has project managers and key personnel with

DoD/DOE experience

– Has project managers that are responsive and stay in

close contact with client

TestAmerica’s

Leadership Position

• Involved in DoD and DOE environmental

programs more than 40 years

• Supported DoD ELAP program since first

proposed in 2007

• Regular contributor at annual conferences

• Largest contributor to 2013 LCS study

• Internal workgroup of 20 people spent 20 weeks

to understand QSM 5 and develop a practical

approach

TestAmerica Labs in DoD

and DOE Programs

* Seattle’s accreditation includes 3 mobile labs operating in Alaska

DoD ELAP DOECAP

Burlington, VT yes

Denver, CO yes yes

Knoxville, TN yes yes

Richland, WA yes yes

Savannah, GA yes

Seattle*, WA yes

St. Louis, MO yes yes

Sacramento, CA yes yes

All labs are operating using a single LIMS system, under a

single quality assurance program, with a pool of project

managers familiar with the QSM

Where To Get Documents

QSM 5.0 posted on DENIX website

www.denix.osd.mil/edqw

2009 TNI + ISO 2005 purchased from TNI

www.nelac-institute.org

Note: 2009 TNI Standard is posted on TNI website, but

does not include ISO text, which is licensed,

you will need to purchase a licensed copy

27

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DoD ELAP and the DoD/DOE QSM - A Laboratory Perspective

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