SOURCES SOUGHT
R -- ISO/IEC 17025 Accreditation - Attachment 1
- Notice Date
- 5/10/2010
- Notice Type
- Sources Sought
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- Department of Agriculture, Animal and Plant Health Inspection Service, Administrative Services Division/Contracting, 100 North 6TH Street, Butler Square 5TH Floor, Minneapolis, Minnesota, 55403
- ZIP Code
- 55403
- Solicitation Number
- APHIS-397347
- Archive Date
- 6/5/2010
- Point of Contact
- Carol R. Dingess, Phone: 612-336-3208
- E-Mail Address
-
carol.dingess@aphis.usda.gov
(carol.dingess@aphis.usda.gov)
- Small Business Set-Aside
- N/A
- Description
- Interested sources are encouraged to complete and return Attachment 1 to the contracting office. Telephonic inquiries will not be honored. Please email all questions regarding subject item(s) prior to Sources Sought closing date to Carol.Dingess@aphis.usda.gov. DESCRIPTION ITEMS - ISO/IEC 17025 Accreditation activity described as 4-year process in Statement of Work (SOW) Interested sources are encouraged to complete and return Attachment 1 to the contracting office. Telephonic inquiries will not be honored. Please email all questions regarding subject item(s) prior to Sources Sought closing date to Carol.Dingess@aphis.usda.gov. Small Business concerns are encouraged to participate. This is not a request for competitive proposals, but instead a market research method to determine interested sources. A determination by the Government not to compete this requirement based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No requests for capability briefings will be honored as a result of this notice. Interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. Please provide Tax I.D. Number, Duns Number, and point of contact information. The Government will not award a contract based on the information received, nor reimburse participants for information or samples they provide. Information or materials provided is strictly voluntary. Please Email or Fax Attachment 1 to Carol Dingess at Carol.Dingess@aphis.usda.gov. fx# 612-336-3550 Email is the preferred method of communication. Telephonic inquiries will not be honored. Closing date for submissions of Statement's of Capability is May 21, 2010 at 4:00PM ET. Anyone interested in doing business with the USDA must also obtain a Dunn and Bradstreet number. If your company does not have a DUNS number, you may contact Dun and Bradstreet directly to obtain one by calling 1- 866-705-5711or via the following website: http://fedgov.dnb.com/webform or at ccr.dnb.com/ccr/pages/CCRSearch.jsp. Anyone interested in doing business with the USDA must complete a Representations and Certifications electronically at http://orca.bpn.gov and be listed in the government's Central Contractor Registrar. You may register on line with www.ccr.gov. or by calling Central Contractors Registration @ 1-888-227-2423 STATEMENT OF WORK Background The Center for Plant Health Science and Technology (CPHST) is the scientific support organization for the Plant Protection and Quarantine (PPQ) division of the Animal and Plant Health Inspection Service (APHIS). The CPHST Beltsville Laboratory (NPGBL) (also known as the National Plant Germplasm and Biotechnology Laboratory [NPGBL]), located at BARC- East Bldg -580 Beltsville, MD 20705, investigates cutting-edge methods and technology from the fields of plant pathology, molecular biology, human and animal clinical diagnostics, and bio-defense to develop, adapt and improve methods for accurate and rapid diagnosis of plant pathogens. Our scientists validate and simplify biochemical and molecular diagnostics prior to stakeholder release and develop clear standard operating procedures. We achieve timely delivery of diagnostics and evaluate, adapt, and implement progressive technologies that are field-deployable and uncomplicated in its operation for emergency response, and eradication and domestic programs. ISO/IEC 17025 is an international standard used by testing and calibration laboratories. This standard is composed of two major components: (1) management requirements and (2) technical requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. This includes an emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. Technical requirements address the competence of staff, methodology, equipment, quality of test results and reporting. Accreditation to the ISO/IEC 17025 international standard will be a formal, international recognition that the CPHST Beltsville Laboratory (NPGBL) is technically capable and competent to perform the work identified in their accreditation scope. Because the mission of the CPHST Beltsville Laboratory (NPGBL) for PPQ includes response to plant pathogens exotic to the U.S. or new to science, the development of a ‘flexible' scope for Accreditation under the ISO/IEC 17025 international standard is the most appropriate Quality Assurance approach. Objective ISO 17025:2005 accreditation for the CPHST Beltsville Laboratory (NPGBL) for a fixed and flexible scope covering "quantitative and qualitative detection of plant pathogens using conventional and real-time PCR". (Conventional PCR includes simplex, multiplex, nested and reverse transcription PCR assays; Real-time PCR includes TaqMan® and SYBR-G technologies in simplex, multiplex, and reverse transcription PCR assays.) Including a flexible scope will allow us to be more responsive to PPQ and afford us the opportunity to modify and/or extend the range of our accredited PCR assays and add new technically-equivalent assays between surveillance visits. Scope of Work 1. Introductory Visit: During this visit, the proposed scope of accreditation will be discussed and reviewed. The accrediting body will explain the accreditation process and answer any questions that the CPHST Beltsville Laboratory (NPGBL) may have concerning accreditation to the ISO 17025:2005 standard. The accrediting body will tour the facility and point out any obvious non-conformances at that time. The accrediting body will sign and provide a copy of the Confidentiality and Conflict of Interest Statement. 2. Document Review: Upon receipt of documentation from the CPHST Beltsville Laboratory (NPGBL) (NPGBL), the accrediting body will perform an evaluation to begin the determination of conformance of the laboratory management system to the ISO 17025:2005 requirements. The accrediting body will deliver to CPHST Beltsville Laboratory (NPGBL) (NPGBL) a document review report indicating which requirements are adequately addressed and a summary of any issues. This report includes the use of the ISO/IEC 17025 accreditation checklist, which shows a clause by clause and paragraph by paragraph review by the accrediting body's assessor. 3. Planning Visit: The accrediting body will visit the CPHST Beltsville Laboratory (NPGBL) to review resolution of any issues from the document review and to verify that other documentation exists supporting the laboratory's management system. The accrediting body's assessor will also perform sample assessment questioning. This allows the assessor to judge if the laboratory is ready for the accreditation assessment. This planning visit is also used to enable the assessor to prepare the plan and schedule for the formal assessment. The accrediting body will provide the CPHST Beltsville Laboratory (NPGBL) with a planning visit report. This report will contain the laboratory's scope and scope description as it is to be formally listed on the accreditation certificate, as appropriate, the status of any document review issues, and any new issues that may have arisen during the planning visit. 4. Accreditation Assessment: The accreditation assessment will be conducted in accordance with the accrediting body's documented procedure. Each type of PCR test(s) shall be sampled and to the extent possible, representative samples of the laboratory's technicians are witnessed performing the accredited procedures. The assessment is used to determine if the laboratory has effectively implemented its quality management system and documentation. The assessment team will document how the laboratory complies with each ISO 17025:2005 requirement using their own organization's documented checklists. Findings will be classified in one of three categories: major nonconformance, minor nonconformance, or opportunity for improvement. The laboratory will receive a detailed accreditation assessment report. This report will contain details about the scope of accreditation, identification and information about the assessors, a summary of the assessment results, and copies of each finding. The report will also include copies of the assessors' accreditation checklist and any notes. 5. Corrective Follow-up Visit (as necessary): Based on the recommendation of the assessment team and results of the assessment, extensive corrective actions and a possible follow-up visit may be required. The timing for this part of the assessment process will be coordinated between the accrediting body and the CPHST Beltsville Laboratory (NPGBL) 6. Accreditation Decision: The accrediting body will review the recommendation of the assessment team and will ensure that all accreditation requirements have been met and are properly documented in accordance with their documented procedures. The accrediting body will notify the CPHST Beltsville Laboratory (NPGBL) when the accreditation decision has been made. 7. Surveillance audits will ensure that all elements of the CPHST Beltsville Laboratory's (NPGBL) quality management system are assessed over the two year audit cycle. 8. Period of Performance The timeline for the activities outlined above is as such: a. Introductory Visit Month 1 b. Document Review Month 2 c. Planning Visit Month 3 d. Accreditation Assessment Month 4 e. Issuance of Accreditation Certificate - within 30 days of initial assessment f. Surveillance Assessment (12 months following initial assessment) g. Re-Accreditation Assessment (24 months following initial assessment) h. Surveillance Assessment (36 months following initial assessment) Contract Scope The contract fee shall include all registration fees, and travel and per diem expenses of the accrediting body representatives. The accrediting body shall accept all Government per diem rates for meals, hotels and travel reimbursement. Qualifications The accrediting body selected for this contract must: 1. Clearly accept and agree to the concept and use of flexible scopes; 2. Be able and willing to accredit a biological testing laboratory to a combination scope that contains both fixed and flexible scope of accreditation aspects within the same accreditation. (This element is best suited to the work conducted by the Beltsville Laboratory.) 3. Be able to accredit laboratories to the ISO 17043 international standard. (This requirement is due to possible future expansion of the quality management system at the Beltsville Laboratory); 4. Meet the requirements of ISO 17011:2004: Conformity Assessment, General requirements for accreditation bodies accrediting conformity assessment bodies. 5. Be recognized by organizations that internationally facilitate acceptance of test and calibration data. Such organizations can include: ILAC, APLAC and IAAC. Time Line The accrediting body will be prepared to initiate this process prior to the beginning of FY2011. Payment Schedule Payment will be made to the vendor upon invoice submittal following the completion of each phase of work.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USDA/APHIS/Contracting/APHIS-397347/listing.html)
- Place of Performance
- Address: National Plant Germplasm and Biotechnology Laboratory (NPGBL), BARC-East, Bldg-580, Beltsville, Maryland, 20705, United States
- Zip Code: 20705
- Zip Code: 20705
- Record
- SN02144528-W 20100512/100510234302-bd9b7cfd45c28054a3fd58c306f859e0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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