RFP_75F40125R00021.pdf

RFP_75F40125R00021

ORA ORS Laboratory third party laboratory accreditation services for ISO 17025

This is a Request for Proposal (RFP) for the U.S. Food and Drug Administration’s (FDA) for ORA ORS Laboratory third party laboratory accreditation services for ISO 17025.

Requirement Synopsis

Purchase of third-party accreditation services so labs can maintain ISO 17025 accreditation for ORS Medical Products and Food and Feed Laboratories.

PROJECT OBJECTIVE

The objective of an accreditation assessment is to establish whether or not a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the “AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, Pharmaceuticals, and Cannabis”. The purpose of this contract is to have an independent, third-party Contractor perform the accreditation assessments and make the proper determinations and to identify any deficiencies.

PROJECT SCOPE

Laboratory accreditation is an important aspect of maintaining Field Laboratories and is an important commitment by FDA. It recognizes the need for FDA Regulatory laboratories to have international recognition and parity; to share data and other information with other accredited labs around the world; to share a common set of policies and procedures in improving operations and harmonization; and, to provide excellent work products that are defensible and consistent.

Proposal Instructions

Please review the attached Statement of Work (SOW) and submit separate technical and business proposals in accordance with the below instructions.

Questions shall be submitted to Amanda Edger at Amanda.edger@fda.hhs.gov by Monday, December 2nd, 2024, by 10 AM EST.

Quote shall be submitted to Amanda Edger at Amanda.edger@fda.hhs.gov by Wednesday, December 11th, 2024, by 10 AM EST.

It is anticipated that this will be a Firm Fixed Price (FFP) type order.

Volume One-Technical Proposal

The Technical Proposal must include the following elements:

• Brief narrative description demonstrating Contractors understanding of and approach for performing the requirement.

• Staffing plan. This should include the availability and names of the individuals, a description of their roles in performing the work required, and the amount of time that Contractor anticipates the individuals will be dedicated to this requirement. It should also indicate which, if any, personnel are employees of the prime or subcontractor (if applicable).

• Resumes from the individuals identified in the staffing plan.

Volume One should not exceed 25 pages in length. The 25 pages do not include the resumes of proposed personnel, which should not exceed 3 pages each. Volume One shall not include any pricing information.

Volume Two-Business Proposal

The business proposal must include the following elements:

• A cover letter signed by an official authorized to bind Contractor.

• Any notes or assumptions.

• Concurrence with a FFP-type order.

Anticipated Period of Performance: 01/01/2025 – 12/31/2025

Please submit the documents in both PDF and Word/Excel formats. FDA will evaluate the proposal to ensure that it is responsive, and that the Contractors proposed labor mix is responsive and appropriate, and that the proposed price is fair and reasonable.

Other Proposal Instructions:

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

Technical Evaluation Factors

Labor Category Description Skill set/expertise

Technical Evaluation Criteria

Technical proposals shall be evaluated individually for compliance and conformance with the solicitation requirements.

Technical Approach

The proposal shall be evaluated to determine if the offeror provides a sound, compliant approach to establish that the offeror possesses a thorough knowledge and understanding of the technical requirements outlined in the Statement of Work as well as providing personnel meeting the experience criteria set forth.

Price Evaluation Criteria

Price reasonableness will be assessed to ensure that the proposed rates accurately reflect an understanding of the required tasks and skills for contract execution, and that the pricing aligns appropriately with the relevant labor categories.

Basis of Award and Evaluation Criteria

From a technical perspective, the Government will evaluate whether the work plan included in the submission will comply with the tasks and goals described in the Statement of Work (SOW) and whether the implementation approach described by the Offeror is technically sound, following standard practices while adhering to government guidelines and regulations.

From a business perspective, the Government will evaluate whether the Offeror’s submission demonstrates a clear understanding of the labor skill mix and level‐of‐effort required to meet the proposed deliverables and whether the labor categories, proposed hours, and overall staffing plan is in line with government assumptions and estimates for the task and is adequate to meet the outlined work plan.

Confidence Ratings

The Government will assess its confidence level in the Offeror’s ability to successfully perform all requirements based on the proposal’s demonstration of technical understanding, personnel qualifications, and management approach. Each proposal will be evaluated according to three primary factors: Technical Approach, Staffing and Key Personnel, and Management Approach.

Confidence ratings of High, Some, or Low will be assigned to each factor to reflect the Government's level of confidence in the Offeror’s approach to meeting solicitation requirements.

This confidence-based evaluation framework enables a best-value assessment, where proposals demonstrating a higher confidence level may justify trade-offs in other factors to achieve the best outcome for the Government.

Confidence Rating Table

Evaluation Factor High Confidence Some Confidence Low Confidence

Factor 1:

Technical Approach

Proposal demonstrates a comprehensive and logical technical approach, with a strong understanding of the work’s purpose, methodologies, and objectives.

Proven and innovative methodologies, especially those relevant to scientific and regulatory agencies, are clearly identified and likely to succeed.

Proposal shows an adequate understanding of the objectives and methodologies, addressing the scope with general relevance and adequacy. Some innovations or proven methodologies may be included.

Limited or unclear technical approach, lacking detail or proven methodologies, leading to low confidence in effective performance and achieving objectives.

Factor 2:

Staffing and Key Personnel

Staffing plan presents a highly qualified team with relevant experience, with all staff matched to appropriate tasks.

All key personnel demonstrate the required expertise for analysis, synthesis, and communication.

Staffing plan generally meets qualifications, with adequate skills and relevant experience.

Some key personnel require clarification on task relevance or commitment.

Limited experience or mismatched qualifications among personnel, raising doubts on capability to perform required tasks, impacting performance confidence.

Factor 3:

Management Approach

Management approach is robust, with a clear organizational structure, proactive management controls, and strong collaboration plans with FDA and subcontractors. Risk management measures are extensive and well-suited for program goals.

Management approach is reasonable, with outlined plans for organizational resources and collaboration, though some areas may lack specificity in risk management or resource use.

Management approach lacks detail or clarity in structure, coordination, or risk controls, leading to low confidence in managing timelines and objectives effectively.

Confidence Rating Definitions:

• High Confidence: The Government has a strong expectation that the Offeror will successfully perform all requirements, based on the proposal’s demonstrated strengths and alignment with project needs.

• Some Confidence: The Government has a reasonable expectation of successful performance, with minor weaknesses in the proposal that could be improved.

• Low Confidence: The Government has little expectation of successful performance, as the proposal shows significant weaknesses or lacks critical details needed to meet requirements effectively.

This table aligns with the specified evaluation factors, allowing the evaluation team to gauge confidence in each aspect of the Offeror’s proposal and support best-value assessments.

Attachments:

1) Statement of Work

2) Pricing Worksheet