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DNDO Guidance for Laboratories on the GRaDER Program


This summary introduces the guidance necessary to involve and qualify laboratories to support the Graduated Radiation/Nuclear Detector Evaluation and Reporting(GRaDERSM) Program, by providing accredited independent testing services to manufacturers and vendors of targeted radiation detectors.

The Domestic Nuclear Detection Office (DNDO) is in the process of establishing a "fee-for testing" program to test and evaluate commercially available technology for detecting nuclear explosive devices, and fissile or radiological material as directed by the Security and Accountability For Every (SAFE) Port Act of 2006. This program will be used to verify the radiation detector performance claims of manufacturers and drive the market to improve the capabilities offered to DHS components, law enforcement and first responders. The GRaDER Program establishes the current American National Standards Institute (ANSI) / Institute of Electrical and Electronic Engineers (IEEE) N42 series consensus standards as the initial acceptable performance baseline for radiation detectors, and incorporates government unique technical capability standards currently under development as the next overall performance objective.

The GRaDER Program is working with Department of Energy (DOE) laboratories and the National Institute of Standards and Technology (NIST) to establish the National Voluntary Laboratory Accreditation Program (NVLAP) as the program by which DNDO assures independent and consistent testing of the commercial-off-the-shelf radiation detectors. Results of the GRaDER Program testing will be made available to Department of Homeland Security components and state, local, and tribal law enforcement and first responder agencies for more informed procurement decisions. It is envisioned that the GRaDER Program will establish a simplified performance test results reporting protocol that may be used to develop procurement and grants award criteria.

The Department helped create and accepted ANSI/IEEE N42 consensus standards for six (6) categories of radiation detection equipment used in the prevention mission role, as well as for data formats and training. Additional ANSI/IEEE standards are being developed to address non-intrusive imaging and other technologies, and to address the response and recovery mission roles. the Department of Homeland Security/DNDO also funded development of NIST Handbook 150-23:2007 (DRAFT) NVLAP Radiation Detection Instruments.

A manufacturer or vendor may have its radiation detection product tested at DNDO-accepted or NVLAP-accredited laboratories. Testing laboratories must be DNDO-accepted or NVLAP-accredited in accordance with NIST Handbooks 150:2006, NVLAP Procedures and General Requirements and 150-23:2007 (DRAFT) NVLAP Radiation Detection Instruments, and the specific ANSI/IEEE N42 standards. DNDO may accept a test facility without NVLAP accreditation for a limited period of time or on a permanent basis based on testing resource availability. Laboratories that are not appropriately NVLAP accredited must self-declare their conformity with the above requirements to DNDO. Labs must also conform with ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories. A checklist used by DNDO to determine laboratory acceptance is attached with this guidance.

Laboratories wishing to support manufacturers/vendors that desire product listings in the GRaDER Program must submit accreditation applications to NIST before submitting Self-Declarations of Conformity to DNDO. In addition, these laboratories must provide a letter to the NVLAP manager that authorizes the NIST/NVLAP to exchange information on the details and status of the application with DNDO.

Once the applicant laboratory has submitted an application for NVLAP accreditation to NIST, it should assemble a Self-Declaration of Conformity to the NIST Handbooks 150 and 150-23-2007 (DRAFT), and ISO/IEC 17025:2005 packet with the standards for which the laboratory will offer accredited testing services. This packet shall include a signed declaration page on laboratory letterhead, a completed copy of an assessment report that attests to the satisfaction of all accreditation conditions (e.g., NIST Handbook 150 Annex C), a description of the scope of testing that the laboratory intends to perform, identification of any and all exceptions to the handbook and ANSI/IEEE N42 standards, a copy of the laboratory's quality control/quality assurance manual and work instructions/procedures for the ANSI/IEEE N42 standards, and a description of the facilities in which testing will be conducted. The Self-Declaration of Conformity packet should be submitted to the DNDO GRaDER Program Manager for consideration.

DNDO will review these conformity claims and, with NIST's assistance, determine if test results from these facilities will be accepted on a temporary or permanent basis. Only test results from DNDO-accepted or fully accredited NVLAP facilities will be considered for evaluation. DNDO reserves the right to conduct site visits of applicant laboratories that submit a Self-Declaration of Conformity, and review and observe testing in progress that supports the GRaDER Program. Once a determination has been made as to the acceptance of a laboratory, DNDO will add the facility to its list on the Department of Homeland Security/DNDO GRaDER Program Web site. DNDO will periodically confirm the NVLAP application status, and the laboratory's accreditation status with the NVLAP Program Manager at NIST. In addition, the laboratory will be subject to any NVLAP surveillance that NIST conducts. Loss of NVLAP accreditation will jeopardize the acceptance of test results reporting for the products under consideration for the GRaDER Program, and may impact the retention of existing GRaDER Program products.

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Testing and Evaluation Process

The testing process includes two phases.

GRaDERSM Program Overview
Radiation/Nuclear Detectors for Prevention

Illustration showing DNDO and NIST to do Product Surveillance on tested products

The first phase will involve testing by DNDO-accepted laboratories participating in the NIST NVLAP accreditation process against existing unclassified, consensus based ANSI/IEEE N42 standards. Subsets of the requirements in these consensus standards will be used to determine DNDO compliance levels. These subsets emphasize radiation detection performance capability first and then environmental and operational capabilities and limitations.

The second phase will entail testing at DNDO sponsored government facilities against more challenging threat based government unique technical capability standards (to be published), and sources under realistic operational and environmental conditions.

In addition to these two phases of GRaDER testing, DNDO will implement a product surveillance program that will be conducted by NIST. This will involve subsequent post-market testing and assessments of radiation detectors that have already been tested and evaluated under the GRaDER Program. Results of these post-market assessments may impact the standing of the radiation detectors identified within the GRaDER Program.

All testing is voluntary and at the vendor's expense.

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Reporting Conventions

DNDO will assign compliance levels based on test results and observations. Laboratories report results as prescribed by the NVLAP. DNDO will require an original signed copy of the test results issued by the NVLAP accredited laboratory.

Observations from testing that relate to radiation detector suitability for missions and DHS component environmental conditions will be captured in comment form and will be provided for the consideration of the users.

Manufacturers may elect to have their test results included in a DNDO-published listing made available to interested parties outside the federal government. This listing may be used by federal, state and local authorities in making procurement and grant decisions. If a manufacturer does not agree to such publication, the test results will not be released outside the federal government. The incentive to participate comes from government procurement and gant programs award criteria. Only equipment that meets the designated criteria will receive government funding.

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Laboratory Participation Process

Once the applicant laboratory has submitted an application for NVLAP accreditation to NIST, it should assemble a Self-Declaration of Conformity to the NIST Handbooks 150 and 150-23-2007 (DRAFT), and International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025:2005 packet with the standards for which the laboratory will offer accredited testing services. This packet shall include a signed declaration page on laboratory letterhead, a completed copy of an assessment report that attests to the satisfaction of all accreditation conditions (e.g., NIST Handbook 150 Annex C), a description of the scope of testing that the laboratory intends to perform, identification of any and all exceptions to the handbook and ANSI/IEEE N42 standards, a copy of the laboratory's quality control/quality assurance manual and work instructions/procedures for the ANSI/IEEE N42 standards, and a description of the facilities in which testing will be conducted. The Self-Declaration of Conformity packet should be submitted to the DNDO GRaDER Program Manager for consideration.

DNDO will review these conformity claims and, with NIST's assistance, determine if test results from these facilities will be accepted on a temporary or permanent basis. Only test results from DNDO-accepted or fully accredited NVLAP facilities will be considered for evaluation. DNDO reserves the right to conduct site visits of applicant laboratories that submit a Self-Declaration of Conformity, and review and observe testing in progress that supports the GRaDER Program. Once a determination has been made as to the acceptance of a laboratory, DNDO will add the facility to its list on the Department of Homeland Security/DNDO GRaDER Program Web site. DNDO will periodically confirm the NVLAP application status and the laboratory's accreditation status with the NVLAP Program Manager at NIST. In addition, the laboratory will be subject to any NVLAP surveillance that NIST conducts. Loss of NVLAP accreditation will jeopardize the acceptance of test results reporting for the products under consideration for the GRaDER program, and may impact the retention of existing GRaDER Program products.

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Test and Evaluation Interest Areas

A complete and independently verifiable detector configuration description must be provided with the application, to include software and firmware version identification and instructions. Applications must include manufacturer or vendor points of contact names, mailing and shipping addresses, telephone number, and electronic mail addresses.

DNDO requires that vendors provide information relating to conformance to other industry and government standards, including those identified below. The GRaDER Program examines certifications from recognized organizations and agencies, and original signed declarations of conformity to these standards. GRaDER verification may include audit and/or testing at the government’s discretion, and as part of the GRaDER post-market surveillance program.

Training Capabilities. DNDO assesses the vendor provided training capabilities and materials as part of the Government unique technical capability standards phase of GRaDER testing. DNDO uses portions of ANSI/IEEE N42.37-2006 American National Standard for Training Requirements for Homeland Security Purposes Using Radiation Detection Instrumentation for Interdiction and Prevention as the standard with which to evaluate training.

Electrical Safety. Electrical equipment that is intended to be used in a regulated workplace will be "certified" to the appropriate safety requirements by an Occupational Safety and Health Administration (OSHA)-accredited Nationally Recognized Testing Laboratory (NRTL), under the General Industry Standards (Part 1910 of Title 29, Code of Federal Regulations - 29 CFR Part 1910). Please vist OSHA for a listing of NRTL facilities:

      http://www.osha.gov/dts/otpca/nrtl/index.html

GRaDER compliance verification for these Test and Evaluation interest areas may include audit and/or testing at the government's discretion, and as part of the GRaDER post-market surveillance program. Any additional costs for government verification of conformity will be at the manufacturer's expense.

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Prime Applicant and Subcontractor/Partner Accreditation and Testing

The following provides guidance to laboratories seeking DNDO acceptance for GRaDER Program test results.  Specifically, this guidance applies to laboratories that are not yet National Voluntary Laboratory Accreditation Program (NVLAP) accredited, and that cannot demonstrate competence in all areas required by the American National Standards Institute (ANSI) / Institute of Electrical and Electronic Engineers (IEEE) N42 consensus standards used by the GRaDER Program.  In such cases, participating laboratories may seek to “team” with outside laboratories as partners or subcontractors in order to test all requirements in the ANSI/IEEE consensus standard.  The entire scope of the applicable standards must be reported by the prime laboratory in order for the test reports to be considered by DNDO.  Therefore, DNDO was asked about procedures for networking with other laboratories in order to comply with the requirements of the GRaDER Program.  The requirements below apply to all members of the participating laboratory team.

The long-term requirements for a laboratory/laboratory team acceptance by DNDO are to be accredited to the appropriate standards [i.e. NIST handbook 150:2006; ISO/IEC 170205, the appropriate ANSI/IEEE radiation detector standard, and the International basic or generic standards required in the ANSI/IEEE standard (e.g., IEC 61000-4-3)].  In addition, the international basic standards require that a test plan be generated that integrates the international standard with the specific features, dimensions and attributes of the system under test.

NIST Handbook 150:2006, section 4.5, indicates that the subcontractor or partner laboratory should be competent and conform to the NIST 150 handbook.  NVLAP accreditation is one acceptable method of demonstrating competence.  Another is a Self Declaration of Conformity (SDOC) that includes a completed application for NVLAP accreditation, or modification of scope of an existing accreditation, along with copies of the documentation supporting the accreditation application as required by the accrediting body.  Included in the SDOC packet submitted to DNDO is the completed DNDO Checklist: NVLAP Applicant Laboratory Self Declarations of Conformity to the GRaDER Program Requirements that is published on the GRaDER Web page for laboratories.  All team members shall comply with this checklist.

The NVLAP has entered into Mutual Recognition Arrangements (MRAs) with a number of organizations that are identified on the NVLAP web site.  By signing these MRAs, NVLAP accepts accreditations granted by signatory partner laboratory accreditation bodies (ABs) that are accomplished through a process that is in conformance with internationally accepted standards and practices.  As a result, NVLAP promotes the acceptance of test results within the respective scopes of accreditation for laboratories accredited by any of the MRA signatory ABs.  Additional guidance may be found on the NVLAP Web site.

SDOCs that are submitted to DNDO for acceptance must include the full scope of the requirements listed on the DNDO Checklist: NVLAP Applicant Laboratory Self Declarations of Conformity to the GRaDER Program Requirements that is published on the GRaDER Web page.  In addition, the following must be accomplished.

  1. The laboratory (prime or subcontractor/partner) that is both familiar with the product and the affected standards shall author test procedures and protocols in a test plan.  The test plan shall be reviewed by all stakeholder parties, including participating laboratories and the test article manufacturer.  The test plan shall document, bridge and integrate the participation of all affected stakeholders in satisfying the requirements of the relevant standards, and shall be incorporated into the policies and procedures of the participating laboratories.  DNDO must receive: a) a draft test plan with the SDOC that describes the linkage and procedures employed by the networked laboratories, b) specific coordinated test plans per each system under test prior to test execution, and c) completed test plans included in the subsequent test reports.
  2. The subcontractor laboratory shall be competent (accredited) in the relevant portions of the ANSI/IEEE standard and the basic international standards.  This requirement may be satisfied by appropriate (e.g., NVLAP, American Association for Lab Accreditation (A2LA), etc.) accreditation to all the standards that are relevant.  If only some standards are on the scope of accreditation, then the accrediting body needs to perform a technical audit of the subcontractor/partner laboratory to verify conformance to the test plan, ANSI/IEEE standard, and the basic international standards.  The subcontractor needs to be accredited for only the relevant portion of the standard.  For example, when the radioactive source detection (primary laboratory responsibility) is combined with the relevant environmental tests (subcontractor/partner laboratory responsibility), the radioactive source detection activities can be performed by the prime NVLAP accredited or DNDO accepted laboratory at the appropriate facility.
  3. Conformance to NIST 150:2006 can be achieved by formal accreditation by NVLAP or other accrediting body with which NVLAP has entered into a Mutual Recognition Arrangement (MRA).
  4. All participating test laboratories shall employ the published test protocols that supplement the ANSI/IEEE N42 standards.  These test protocols are available from NIST via the NVLAP Program Manager for Homeland Security Applications - Radiation Detection Instruments.

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