Clinical Laboratory Services

Added: Jan 26, 2018 3:00 pm

PRE-SOLICITATION NOTICE OF INTENT
NON-COMPETITIVE

INTRODUCTION
PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition, Contracts Management Branch Blue, on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract to Quest Diagnostics, Nichols Institute, Inc., 14225 Newbrook Drive, Chantilly, VA 20151, for reference clinical laboratory services in support of the NIA HANDLs study.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 621511 with a Size Standard of $32.5 million.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-95, dated January 19, 2017.

STATUTORY AUTHORITY
This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source.

DESCRIPTION OF REQUIREMENT

Project Title: Reference clinical laboratory services for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study.

The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the NIA HANDLS physicians. Services shall include the transportation of clinical laboratory specimens to the contractor's laboratory(ies) (including providing the shipping/pickup containers), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility.

Purpose and Objectives
This project is a continuation of a need that is currently provided under contract HHSN271201400124C, which expires June 30, 2018. These services have been provided via the incumbent since 2004. HANDLS is a longitudinal study in which participants are compared to one another and to themselves over time. Consistency in measurement is paramount because NIA HANDLS investigators must attribute any changes observed to changes in HANDLS participants, not to changes in the assays. Although repeatability is important for all measures in HANDLS, it is particularly crucial for clinical laboratory assays because these tests have specific reference ranges that define abnormal health conditions. Reference ranges vary among different vendors and each vendor is responsible via Clinical Laboratory Improvement Amendment (CLIA) program certification for developing and standardizing their own reference ranges. Consequently, it is crucial to maintain consistency by using the same laboratory facilities for performing HANDLS clinical assays. Not doing so would introduce unmeasurable error in our assessments of change over time that would invalidate estimates of variation associated with age, race, and socioeconomic status. Changes in methodology and reference ranges might also have untoward effects on HANDLS participants. Participants may provide these results to their physicians, who may inappropriately interpret changes in clinical status unless laboratory methods are consistent over time. Therefore, NIA requires an agreement with the current contractor.

Period of Performance
The period of performance will consist of one 12-month base period and three 12-month option periods as specified below:

Base Year: July 1, 2018 - June 30, 2019
Option Year 1: July 1, 2019 - June 30, 2020
Option Year 2: July 1, 2020 - June 30, 2021
Option Year 3: July 1, 2021 - June 30, 2022

CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.

Responses to this notification must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by Feburary 5, 2018 at 9:00 AM Eastern Time and must reference number HHS-NIH-NIDA(AG)-NOI-18-013.

Responses must be submitted electronically to Jon Gottschalk, jon.gottschalk@nih.gov, and must reference the solicitation number HHS-NIH-NIDA(AG)-NOI-18-013, on your electronic request. FAX requests are not accepted.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.