FDASS123093.pdf

Title:

International Organization for Standardization/ International Electro-technical

1.0 Background

As part of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), enacted January 4, 2011, Section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to establish a program for the recognition of accreditation bodies in support of the accreditation of laboratories in areas of testing, calibration and proficiency testing. The primary role of the Center for Food Safety and Applied Nutrition (CFSAN) Moffett Campus Proficiency Testing Laboratory (Moffett PT) is to conduct proficiency testing programs for state, local and private laboratories that perform milk, shellfish and other food testing. The PT Laboratory provides samples to customers to test their ability to identify/analyze the samples. Results are returned to the Moffett PT laboratory for analysis and review.

Many regulatory and public health decisions are supported by laboratory data. If the data are of questionable quality, then these decisions may be untenable or incorrect. Moffett proficiency testing samples include PT studies for both chemical and microbiological analysis in a variety of food matrices and are specifically designed to fulfill the requirements of the agency’s needs. Moffett PT Laboratory provides proficiency study samples for a variety of regulatory, food safety and food defense mandates.

Proficiency testing accreditation ensures the PT laboratory delivers a consistent level of quality to its customers by having well defined and regularly reviewed processes and procedures through a rigorous assessment, conducted by an independent science-based organization. As a PT provider Moffett must have a Laboratory Quality Assurance program to ensure that the data integrity that underlies agency decisions are reliable; and meet standards described by the International Organization for Standardization/ International Electro-technical Commission, (ISO/IEC) 17043 accreditation programs. ISO/IEC 17043 accreditation assures the overall capability and competency of the Moffett PT laboratory and its Quality Management Systems. Accreditation indicates that the Moffett PT laboratory is generally competent to perform, supply and analyze specific PT test samples to customers.

2.0 Objective

The objectives of this contract are as follows:

Achieve international accreditation as a proficiency testing provider for Moffett proficiency studies, to include PT studies for both chemical and microbiological analysis Assure Moffett Proficiency Testing (PT) laboratory conforms to the International Standard

ISO/IEC 17043 through the accreditation process.

Assure competence, to customer, as PT provider through formal recognition by ISO/IEC17043 accreditation.

3.0 Scope

Independently, and not as an agent of Government, the Contractor shall furnish the necessary personnel, materials, services and otherwise do all things necessary for, or incident to, the performance of the work described below. The Contractor shall work closely with the Contracting Officer’s Representative (COR) and in cooperation with the Moffett Center PT Laboratories for the ISO 17043 accreditation assessment.

4.0 General Requirements

4.1 TASK 1: Reassessment (Year One)

Task: Reassessment (RA):

4.1.1. The contractor shall provide the Contracting Officer Representative (COR) with an assessment schedule and plan for the Moffett Proficiency Testing Laboratories approximately ten (10) days prior to the assessment to include the number of assessment days needed to complete the accreditation process.

4.1.2. Prior to the reassessment, the contractor shall conduct a document review to verify that the Moffett Proficiency Testing Laboratory provider has addressed understands and documented all management system requirements. The contractor shall ask the Moffett Proficiency Testing Laboratories to complete an accreditation checklist with quality system references identified. The results of the document review shall include a completed accreditation checklist for the relevant accreditation program. The checklist shall be used to provide a paragraph-by-paragraph indication of how the Moffett Proficiency Testing Laboratories meets the requirements. The checklist shall include quality system references. Findings of this document review shall be written in a report for submission to COR.

4.1.3. As part of the reassessment, the Contractor shall sample the Moffett Proficiency Testing Laboratory provider quality and technical management system and determines through interviews and by reviewing procedures, data, and records whether the Moffett Proficiency Testing Laboratory provider system is effectively implemented and meets applicable requirements, ISO 17043. The Contractor shall conduct along with the COR an on-site assessment following the document review, which shall include at a minimum:

Review of the quality management system, to include a thorough review of the Moffett Proficiency Testing Laboratories compliance to the accreditation requirements.

Process for handling complaints including any corrective action taken (records shall be made available to the Contractor upon request).

Review of the procedures in place to ensure that all personnel are aware of and abide by standards of conduct for Moffett Proficiency Testing Laboratories providers and confidentiality of assigned values and participant results.

Assessment of the general awareness throughout the organization of the requirements of the standards being assessed, as appropriate.

Opening meeting with the Proficiency Testing management.

Daily assessor meetings and Proficiency Testing management debriefings.

Review of any open Opportunity for improvements (OFIs) from the document review and planning visit (if applicable).

Verification of proficiency testing/inter-laboratory comparisons (PT/ILC) participation for at least one of the parameters/categories identified in the scope (if available), done within a twelve (12) month period prior to the accreditation assessment.

Verification of an internal audit completed within a twelve (12) month period prior to the accreditation assessment, to include witnessing of a proposed scope parameter.

Verification of a completed management review completed within a twelve (12) month period prior to the accreditation assessment.

Review of the laboratory’s four (4) year plan for PT/ILC participation where applicable.

Verification of competence in estimating measurement uncertainty where applicable.

Review of uncertainty budgets or other calculations of measurement uncertainty (as applicable) to ensure they are available and adequate for all relevant proposed scope parameters.

Review of the format of proposed accredited certificates/reports (with data) and non-accredited certificates/reports (if available).

Witnessing of the proposed scope of accreditation to assess technical competence.

Witnessing of any internal (off-scope) calibrations done to disseminate traceability.

Final assessment team meeting to discuss findings.

Closing meeting.

4.1.4. The Contractor shall use the appropriate assessment ISO 17043 checklist to document how each requirement is met while in the areas being assessed and they shall document witnessing. All notes and forms shall be kept on the assessment checklist and become part of the accreditation records.

4.1.5. One (1) year after the reassessment, the contractor shall conduct at a minimum a one (1) day surveillance assessment (SA) or surveillance document review (SDR) of the Moffett Proficiency Testing Laboratory management system to ensure it has been maintained and remains effective.

4.1.6. If the Moffett Proficiency Testing Laboratory provider demonstrates stability and competence after the Task One (1) (Year One) reassessment, the Contractor in consultation with the COR, shall consider a surveillance document review. In such a case, the Moffett Proficiency Testing Laboratory shall submit the following information in-between reassessments:

Quality manual if there has been any change since the last visit Evidence of closure/implementation of prior nonconformities from recent assessment from the contractor.

Statistical data and analysis as appropriate for each PT program Management review, internal audit, and corrective action from the previous year Brief narrative describing any changes in ownership, management, and organization structure.

Evidence of any complaints and their resolution, including any corrective action taken Internal audit report Management review minutes Representative proficiency test report issued.

4.1.7. The Contractor shall inform the COR of Moffett Proficiency Testing Laboratory opportunities for improvement (OFIs), which shall be written to document concerns and questions that may be identified as nonconformities during the reassessment. The Contractor shall resolve all OFIs identified during the document review prior to the reassessment along with the COR and Moffett Proficiency Testing Laboratory.

4.1.8. The Contactor shall decide along with COR whether to proceed if any OFIs are not resolved prior to the accreditation assessment. If contractor and COR believes the Moffett Proficiency Testing Laboratory provider needs further preparation, the reassessments shall be turned into practice assessments if the Moffett Proficiency Testing Laboratory’s management, agrees.

NONCONFORMITIES (NC)

4.1.9. The contractor shall write nonconformities (NCs) to highlight minor and/or major deficiencies in the management system. These findings and timeframe for their closure shall be reviewed at the closing meeting of each visit. The contactor shall classify each NC as major or minor according to these guidelines and must notify the COR and Moffett Proficiency Testing Laboratory during the assessment when a major NC is identified.

4.1.10. The Moffett Proficiency Testing Laboratory provider shall respond to any NC within thirty (30) days of the closing meeting (unless otherwise agreed by COR, Moffett Proficiency Testing Laboratory Provider and the contractor) for review by the contractor or designee.

CORRECTIVE ACTION AND FOLLOW - UP VISIT

4.1.11. The Moffett Proficiency Testing Laboratory provider will respond to the NCs within sixty (60) days of the closing meeting and the responses must be accepted by the COR and contractor before the accreditation process can be completed. The contractor shall inform the COR if a finding is to be withdrawn, judged redundant or invalid, change the category of a finding, or require additional input from Moffett Proficiency Testing Laboratory provider.

4.2 TASK 2: Surveillance (Year Two)

4.2.1. The Contractor shall notify the COR in writing at least thirty (30) days before the surveillance assessment or surveillance document review.

4.2.2. The Contractor, along with the COR, shall assess the Moffett Proficiency Testing Laboratory provider through surveillance, one year after the reassessment. The surveillance assessment shall include:

Opening meeting.

Verification of proper use of the appropriate accreditation symbol Review of any changes to the Moffett Proficiency Testing Laboratory provider management system.

Review of any changes to the accreditation scope.

Assessment of specific sections of relevant checklists based on minimum requirements and the contractor’s previous review of Moffett Proficiency Testing Laboratory provider records. For a second consecutive surveillance assessment, key sections not assessed in the previous surveillance assessment should be included.

Sampling of the scope of accreditation.

Assessment of the general awareness throughout the organization of the requirements of the standards being assessed, as appropriate.

Review of the corrective action system.

Review of any results from proficiency testing, as applicable, including corrective action for any outliers.

Review of the Moffett Proficiency Testing Laboratory provider four (4)year plan, as applicable.

Verification of implementation of corrective action for nonconformities from the previous assessment.

Assessment of management reviews.

Assessment of the internal audit system and its effectiveness.

Assessment of complaints and corresponding corrective action.

Recommendation and subsequent determination concerning continuing accreditation.

Closing meeting.

4.2.3. The contractor shall write nonconformities (NCs) to highlight minor and/or major deficiencies in the management system. These findings and timeframe for their closure shall be reviewed at the closing meeting. The COR provide a final report thirty (30) days after closing meeting.

4.3 TASK 3: Reassessment (Year Three)

4.3.1. The Contractor, along with the COR, shall reassess the Moffett Proficiency Testing Laboratory provider two years after the Task One (1)Year One reassessment. The Contractor shall notify the COR in writing at least thirty (30) days before the reassessment.

The reassessment shall be performed in the same manner as the reassessment specified in Task One (1) (Year One):

5.0 Deliverables

The Contractor shall provide oral and written status reports. The reports shall include the work that has been accomplished, the activities planned for the next period, and any barriers to success. The Contractor shall provide all written reports in electronic format with reading/writing capability using Microsoft Office applications to the COR/Project Officer. The Contractor shall be available to discuss with the COR/Project Officer any current or anticipated problems. ·

SCHEDULE OF DELIVERABLES

Task No.

Description Deliverables Frequency

TASK 1: Reassessment: (BASE YEAR)

4.1.1 Contractor provides the COR assessment schedule

and plan Reassessment plan

Ten (10) days after contract is awarded

4.1.2 Contractor will perform a Document review of

findings. Contractor will provide PT with accreditation checklist

Written report of findings to COR

Twenty (20) days after contract is awarded

4.1.3, 4.1.4

Conduct reassessment

On site assessment (Moffett Proficiency Testing Laboratory)

Twenty-five (25) days after contract awarded for up to five (5) days

4.1.5, 4.1.6

Contractor provides nonconformities at audit closing meeting and provides

Final written report to COR

Thirty (30) days after closing meeting

4.1.7, 4.1.8

Contractor will provide COR in writing of all OFI’s observed while conducting initial on-site assessment.

Written report at the end of each day of auditing

Five (5) written reports, one for each day of the initial audit

4.1.9, 4.1.10

Contractor shall write nonconformities (NCs) closure shall be reviewed at the closing meeting of each visit.

Discussion Closing meeting for each day of the initial audit

4.1.11 Contractor shall inform the COR if a finding is to be

withdrawn, judged redundant or invalid, change the category of a finding, or require additional input from Moffett Proficiency Testing Laboratory provider.

Written report Twenty (20) days after closing meeting

TASK 2: SURVEILLANCE (YEAR TWO)

4.2.1 Contractor will notify the COR in writing at least

thirty (30) days before the surveillance assessment.

A written Notice of Surveillance assessment

One (1) year after the reassessment and thirty

Poullard, Teiana This is different from the previous one. Please see under the schedule of deliverables

Watson, Cecelia This is the same-not sure what you mean

(30) days before the surveillance assessment.

4.1.6, 4.2.1

Reassessment Moffett Proficiency Testing Laboratory provider one (1) year after the reassessment:

• Opening meeting.

• Verification of proper use of the appropriate accreditation symbol

• Review of any changes to the Moffett

Proficiency Testing Laboratory provider management system.

• Review of any changes to the accreditation scope.

• Assessment of specific sections of relevant checklists based on minimum requirements and the contractor’s previous review of Moffett Proficiency Testing Laboratory provider records. For a second consecutive surveillance assessment, key sections not assessed in the previous surveillance assessment Should be included.

• Sampling of the scope of accreditation.

• Assessment of the general awareness throughout the organization of the requirements of the standards being assessed, as appropriate.

• Review of the corrective action system.

• Review of any results from proficiency testing, as applicable, including corrective action for any outliers.

• Review of the Moffett Proficiency Testing Laboratory provider four-year plan, as applicable.

• Verification of implementation of corrective action for nonconformities from the previous assessment.

• Assessment of management reviews.

• Assessment of the internal audit system and its effectiveness.

• Assessment of complaints and corresponding corrective action.

• Recommendation and subsequent determination concerning continuing accreditation.

• Closing meeting.

On-site assessment (Moffett Proficiency Testing Laboratory)

Surveillance audit one day

4.2.3 Contractor provides written nonconformities at audit

closing meeting and final report thirty (30) days after closing meeting

Final written report to COR

Thirty (30) days after closing meeting

TASK 3: REASSESSMENT (YEAR THREE)

4.3.1 Contractor will notify the COR in writing at least

thirty (30) days before the reassessment.

A written Notice of Reassessment to COR

Two (2) year after the reassessment and thirty

(30) days before the Reassessment.

4.3.2 Reassess Moffett Proficiency Testing Laboratory

provider two (2) years after the reassessment:

• Opening meeting.

• Verification of proper use of the appropriate

ANAB accreditation symbol and Accredited CAB Combined ILAC MRA Mark, if applicable.

• Review of any changes to the accreditation scope.

• Review of any changes to the Moffett Proficiency Testing Laboratory provider management system.

• Review of the applicable requirements using the relevant checklists.

• Verifying and, as appropriate, witnessing of the entire scope of accreditation.

• Assessment of the general awareness throughout the organization of the requirements of the standards being assessed, as appropriate.

• Review of any results from proficiency testing, as applicable, including corrective action for any outliers.

• Review of the PT/ILC four-year plan, as applicable.

• Review of alternate quality assurance methods.

• Verification of effective implementation of corrective action for nonconformities from the previous assessment.

• Review of the corrective action system.

• Assessment of management reviews.

• Assessment of the internal audit system and its effectiveness.

• Review of complaints and corresponding corrective action.

• Recommendation and subsequent determination concerning continuing accreditation.

• Daily assessor meetings and customer progress meetings (where applicable).

• Closing meeting.

On-site (Moffett Proficiency Testing Laboratory)

On-site reassessment four (4) days

4.3.3 Contractor provides written nonconformities at audit

closing meeting and final report Thirty (30 days after closing meeting

Final written report to COR

Thirty (30) days after closing meeting

6.0 Personnel Qualifications

The Contactor shall be a U.S. accreditation body for management systems (for example, ISO 9001) certification bodies, and provides accreditation for ISO/IEC 17043 proficiency testing providers.

The Contractor shall have significant experience accrediting ISO/IEC 17043 for PT providers. The Contractor shall have experience accrediting one of the two federal food agencies (FDA or USDA) within the US Government to the ISO/IEC 17043 standard.

The Contactor shall be a signatory of the multilateral recognition arrangements (MRAs) of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC). The contractor must also be a signatory of the Inter-American Accreditation Cooperation (IAAC) multilateral recognition arrangement (MLA). Must be domestically, recognized by the Federal Communications Commission, the National Institute of Standards and Technology (NIST) National Voluntary Conformity Assessment Systems Evaluation Program (NVCASE), the NELAC Institute (TNI), and other private and government organizations. The contractor must be recognized internationally, nationally, by states and regionally.

The Contractor shall be evaluated every four (4) years by its peers in the international accreditation community. To include evaluation of its compliance with the requirements of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies.

The Contractor shall provide resumes and statements regarding experience related to the project requirements for all key personnel involved in assisting with this effort and the CFSAN has the right to refuse personnel deemed unqualified.

The COR reserves the right to approve in advance Contractor personnel to be assigned to this project and, should it be necessary, to disapprove the continuing assignment of the Contractor personnel provided under the contract. If any employee of the Contractor is unable to perform due to illness, resignation or other factors beyond the Contractor’s control, the Contractor shall immediately provide acceptable substitute personnel.

7.0 Personnel Security Clearance Requirements

Risk level of this requirement is Level 5. New employees and all Contractor staff under this contract will be required to submit required documentation, including fingerprints, for security clearances for Contractor positions of public trust in FDA at the 5 Level. FDA will automatically reject any Contractor staff not passing the security background check.

8.0 Place of Performance

The work involved in the execution of this Contract shall be performed at the government site primarily at the Moffett Center in Summit-Argo, Illinois, when approved by the COR. The contractor shall be available and accessible as necessary, during hours that are consistent with the Moffett Proficiency

Testing Laboratory, to perform the duties described in this scope of work. Normal working hours of operation are 8:00A.M to 4:00P.M., Monday through Friday, except Federal Holidays.

9.0 Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or

GFI)

The Government will provide the equipment (laptop) equivalent to Government employees that are necessary to perform the services required in the Statement of Work (SOW). The Contractor shall use the Government-furnished property only for the performance of work under this task order. The COR will provide the most recent edition of the Moffett Quality Manual, SOPs, forms and guidance documents and internal assessment accreditation audit.

10.0 Travel

The Contractor is required to travel to the FDA government site Moffett Center in Summit-Argo, Illinois at least three (3) times during the life of the contract; year one (1) the reassessment, year two (2) surveillance assessment and year three (3) reassessment.

11.0 Period of Performance

The Performance Period for this task order shall consist of a twelve (12) month base period and two (2) twelve (12)-month option periods.

Base Year September 1, 2024 – August 31, 2025

Option Year 1 September 1, 2025 – August 31, 2026

Option Year 2 September 1, 2026 - August 31, 2027

Option Year 3 September 1, 2027 – August 31, 2028

12.0 Contracting Officer's Representative (COR)

Cecelia Watson Cecelia.watson@fda.hhs.govCecelia.watson@fda.hhs.gov Phone: 240-346-3687

13.0 SECTION 508 COMPLIANCE

Section 508 of the Rehabilitation Act of 1973 (29. U.S.C. 794d), as amended by the Workforce Investment Act 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this award must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information mailto:Cecelia.watson@fda.hhs.gov mailto:Cecelia.watson@fda.hhs.gov about Section 508 is available at http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards. This requirement is shall comply with the following standards.

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance (Appendix C, Functional Performance Criteria and Technical

Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed a https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except up approval of the Contract Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

All EIT must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at: https://www.section508.gov/.

14. OCCUPATIONAL SAFETY AND HEALTH TERMS AND CONDITIONS

1. The contractor is responsible for ensuring contractor personnel comply with applicable OSHA requirements, report unsafe conditions or activities to the Contracting Officer’s Representative (COR), and avoid actions and conditions that may result in an accident.

2. The contractor shall submit to the COR a site-specific safety and accident prevention plan and OSHA 300A reports from the past three (3) calendar years.

3. The contractor shall report all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than twenty four (24)hours after discovery of the incident, illness or injury, or near-miss.

4. The contractor shall provide an investigation report at no cost to the Government for all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than twenty four (24) hours after the conclusion of the investigation of the incident, illness or injury, or near-miss.

5. The contractor shall report all activities or conditions that pose imminent danger or harm to persons, animals, or Government property immediately upon discovery to FDA Security or directly to local emergency services, as appropriate. In addition, the contractor shall report the incident to the COR immediately thereafter.

http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.section508.gov/

6. The contractor shall be responsible for any and all costs, expenses, and other obligations paid or incurred, due to the contractor’s noncompliance with federal, state, and/or local laws or ordinances.

7. As applicable, the contractor shall provide personal protective equipment (e.g., hard hats, safety glasses, work gloves) for anticipated hazards and ensure that contractor personnel wear the prescribed safety and health equipment within the work area, as prescribed by 29 CFR part 1910, Subpart I. The contractor shall provide instructions to personnel on the proper wear, maintenance, and limitations of the personal protective equipment prior to commencement of any work under the acquisition.

8. Prior to bringing any hazardous material to an FDA facility, the contractor shall provide the COR copies of any Safety Data Sheets (SDS) to obtain advance, written authorization.

9. Unless otherwise specified in the acquisition, the contractor is responsible for removing any hazardous material, or any material with an SDS, that the contractor brought with them for use at an FDA facility before or during performance of the acquisition.

15.0 OBSERVANCE OF FEDERAL HOLIDAYS

Government personnel observes the following days as holidays:

New Year’s Day Labor Day Martin Luther King Day Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure. If more than forty (40) hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the Contracting Officer.